Analyte sensor
First Claim
1. A device for measuring an analyte in a host, the device comprising:
- a sensor operably connected to sensor electronics, the sensor electronics configured for measuring an analyte in a host;
at least one electrical contact configured to connect the sensor to the sensor electronics; and
a sealing member, wherein the sealing member at least partially surrounds at least one of the sensor and the electrical contact, wherein the sealing member comprises a material having a durometer hardness of from about 5 Shore A to about 80 Shore A.
1 Assignment
0 Petitions

Accused Products

Abstract
The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.
613 Citations
Analyte monitoring device and methods of use | ||
Patent #
US 7,885,699 B2
Filed 08/06/2010
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for providing continuous calibration of implantable analyte sensors | ||
Patent #
US 7,885,698 B2
Filed 02/28/2006
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 7,885,697 B2
Filed 03/10/2005
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
ANALYTE SENSOR | ||
Patent #
US 20110024307A1
Filed 07/01/2010
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Low oxygen in vivo analyte sensor | ||
Patent #
US 7,899,511 B2
Filed 01/17/2006
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 7,905,833 B2
Filed 06/21/2005
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
TRANSCUTANEOUS ANALYTE SENSOR | ||
Patent #
US 20110077490A1
Filed 09/29/2010
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Low oxygen in vivo analyte sensor | ||
Patent #
US 7,901,354 B2
Filed 05/01/2008
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 7,869,853 B1
Filed 08/06/2010
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 7,946,984 B2
Filed 03/10/2005
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 7,949,381 B2
Filed 04/11/2008
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte monitoring system and method | ||
Patent #
US 7,920,907 B2
Filed 06/07/2007
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring system and methods | ||
Patent #
US 7,928,850 B2
Filed 05/08/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Device and method for determining analyte levels | ||
Patent #
US 7,970,448 B2
Filed 04/19/2010
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and apparatus for providing dynamic multi-stage signal amplification in a medical device | ||
Patent #
US 7,948,369 B2
Filed 08/02/2010
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Blood glucose tracking apparatus | ||
Patent #
US 7,976,778 B2
Filed 06/22/2005
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 8,000,901 B2
Filed 08/09/2010
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Device and method for determining analyte levels | ||
Patent #
US 7,974,672 B2
Filed 04/19/2010
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 7,996,158 B2
Filed 05/14/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Techniques to improve polyurethane membranes for implantable glucose sensors | ||
Patent #
US 8,053,018 B2
Filed 01/15/2010
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Glucose measuring device for use in personal area network | ||
Patent #
US 8,066,639 B2
Filed 06/04/2004
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Techniques to improve polyurethane membranes for implantable glucose sensors | ||
Patent #
US 8,050,731 B2
Filed 11/16/2005
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte sensor transmitter unit configuration for a data monitoring and management system | ||
Patent #
US 8,029,441 B2
Filed 02/28/2006
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 7,860,544 B2
Filed 03/07/2007
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Device and method for determining analyte levels | ||
Patent #
US 7,792,562 B2
Filed 12/22/2009
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Continuous glucose monitoring system and methods of use | ||
Patent #
US 7,811,231 B2
Filed 12/26/2003
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Low oxygen in vivo analyte sensor | ||
Patent #
US 7,771,352 B2
Filed 05/01/2008
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and system for providing calibration of an analyte sensor in an analyte monitoring system | ||
Patent #
US 7,653,425 B2
Filed 08/09/2006
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Dual electrode system for a continuous analyte sensor | ||
Patent #
US 7,831,287 B2
Filed 04/28/2008
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Device and method for determining analyte levels | ||
Patent #
US 7,835,777 B2
Filed 12/22/2009
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and apparatus for providing dynamic multi-stage signal amplification in a medical device | ||
Patent #
US 7,768,387 B2
Filed 04/14/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 7,768,386 B2
Filed 07/31/2007
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Transcutaneous medical device with variable stiffness | ||
Patent #
US 7,783,333 B2
Filed 03/10/2005
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte sensor | ||
Patent #
US 7,828,728 B2
Filed 02/14/2007
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Close proximity communication device and methods | ||
Patent #
US 7,826,382 B2
Filed 05/30/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor | ||
Patent #
US 7,857,760 B2
Filed 02/22/2006
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
TRANSCUTANEOUS ANALYTE SENSOR | ||
Patent #
US 20090163790A1
Filed 01/23/2009
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
HYDROGEL THIN FILM FOR USE AS A BIOSENSOR | ||
Patent #
US 20090170124A1
Filed 12/18/2008
|
Current Assignee
Covidien LP
|
Original Assignee
Nellcor Puritan Bennett LLC
|
ANALYTE SENSOR SUBASSEMBLY AND METHODS AND APPARATUSES FOR INSERTING AN ANALYTE SENSOR ASSOCIATED WITH SAME | ||
Patent #
US 20090234212A1
Filed 03/17/2009
|
Current Assignee
WaveForm Technologies Inc.
|
Original Assignee
Isense Corporation
|
Silicone based membranes for use in implantable glucose sensors | ||
Patent #
US 7,613,491 B2
Filed 04/14/2006
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte sensor | ||
Patent #
US 7,640,048 B2
Filed 02/22/2006
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Coding module and sensing meter and system therefor | ||
Patent #
US 20060290488A1
Filed 05/26/2006
|
Current Assignee
Bionime Corporation
|
Original Assignee
Bionime Corporation
|
Method and apparatus for providing rolling data in communication systems | ||
Patent #
US 8,123,686 B2
Filed 03/01/2007
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Silicone based membranes for use in implantable glucose sensors | ||
Patent #
US 8,064,977 B2
Filed 07/29/2009
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 8,103,471 B2
Filed 05/14/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method of calibrating of an analyte-measurement device, and associated methods, devices and systems | ||
Patent #
US 8,116,840 B2
Filed 10/30/2007
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Hydrogel thin film for use as a biosensor | ||
Patent #
US 8,092,993 B2
Filed 12/18/2008
|
Current Assignee
Covidien LP
|
Original Assignee
Nellcor Puritan Bennett LLC
|
RF tag on test strips, test strip vials and boxes | ||
Patent #
US 8,115,635 B2
Filed 11/24/2009
|
Current Assignee
Therasense Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing leak detection in data monitoring and management systems | ||
Patent #
US 8,112,240 B2
Filed 04/29/2005
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Device and method for automatic data acquisition and/or detection | ||
Patent #
US 8,121,857 B2
Filed 02/14/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method, system and computer program product for real-time detection of sensitivity decline in analyte sensors | ||
Patent #
US 8,135,548 B2
Filed 10/26/2007
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated, University of Virginia Patent Foundation
|
Analyte sensor | ||
Patent #
US 8,133,178 B2
Filed 02/22/2006
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and apparatus for providing dynamic multi-stage amplification in a medical device | ||
Patent #
US 8,149,103 B2
Filed 05/23/2011
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring system and methods | ||
Patent #
US 8,149,117 B2
Filed 08/29/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing data processing and control in medical communication system | ||
Patent #
US 8,140,142 B2
Filed 04/14/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for determining analyte levels | ||
Patent #
US 8,140,312 B2
Filed 01/31/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 8,160,669 B2
Filed 04/11/2007
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Calibration techniques for a continuous analyte sensor | ||
Patent #
US 8,160,671 B2
Filed 09/01/2010
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,162,829 B2
Filed 03/30/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,175,673 B2
Filed 11/09/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,177,716 B2
Filed 12/21/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for detecting false hypoglycemic conditions | ||
Patent #
US 8,185,181 B2
Filed 10/29/2010
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Electrode systems for electrochemical sensors | ||
Patent #
US RE43,399 E1
Filed 06/13/2008
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Continuous glucose monitoring system and methods of use | ||
Patent #
US 8,187,183 B2
Filed 10/11/2010
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for providing analyte monitoring | ||
Patent #
US 8,211,016 B2
Filed 09/26/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method of calibrating an analyte-measurement device, and associated methods, devices and systems | ||
Patent #
US 8,219,175 B2
Filed 06/29/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method of calibrating an analyte-measurement device, and associated methods, devices and systems | ||
Patent #
US 8,219,174 B2
Filed 06/29/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Correlation of alternative site blood and interstitial fluid glucose concentrations to venous glucose concentration | ||
Patent #
US 8,216,138 B1
Filed 10/23/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for providing analyte monitoring | ||
Patent #
US 8,216,137 B2
Filed 07/20/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Optimizing analyte sensor calibration | ||
Patent #
US 8,219,173 B2
Filed 09/30/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,224,413 B2
Filed 10/10/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and device for providing offset model based calibration for analyte sensor | ||
Patent #
US 8,224,415 B2
Filed 01/29/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
RF tag on test strips, test strip vials and boxes | ||
Patent #
US 8,223,021 B2
Filed 11/24/2009
|
Current Assignee
Therasense Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,226,558 B2
Filed 09/27/2010
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,226,557 B2
Filed 12/28/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,226,555 B2
Filed 03/18/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring devices and methods therefor | ||
Patent #
US 8,226,891 B2
Filed 03/31/2006
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor | ||
Patent #
US 8,231,531 B2
Filed 06/01/2006
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,231,532 B2
Filed 04/30/2007
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Blood glucose tracking apparatus and methods | ||
Patent #
US 8,236,242 B2
Filed 02/12/2010
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 8,239,166 B2
Filed 05/14/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,235,896 B2
Filed 12/21/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Calibration techniques for a continuous analyte sensor | ||
Patent #
US 8,249,684 B2
Filed 09/01/2010
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Oxygen enhancing membrane systems for implantable devices | ||
Patent #
US 8,255,032 B2
Filed 01/15/2010
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Oxygen enhancing membrane systems for implantable devices | ||
Patent #
US 8,255,030 B2
Filed 04/25/2006
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,255,031 B2
Filed 03/17/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Oxygen enhancing membrane systems for implantable devices | ||
Patent #
US 8,255,033 B2
Filed 04/25/2006
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,260,392 B2
Filed 06/09/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 8,260,558 B2
Filed 05/14/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,265,726 B2
Filed 11/09/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Blood glucose tracking apparatus and methods | ||
Patent #
US 8,268,243 B2
Filed 12/28/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,273,022 B2
Filed 02/13/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,275,439 B2
Filed 11/09/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Implantable analyte sensor | ||
Patent #
US 8,277,713 B2
Filed 05/03/2004
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 8,280,475 B2
Filed 02/23/2009
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,287,454 B2
Filed 09/27/2010
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor | ||
Patent #
US 8,287,453 B2
Filed 11/07/2008
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,306,598 B2
Filed 11/09/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,346,336 B2
Filed 03/18/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,346,337 B2
Filed 06/30/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor calibration management | ||
Patent #
US 8,346,335 B2
Filed 01/30/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,353,829 B2
Filed 12/21/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,357,091 B2
Filed 12/21/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
RF tag on test strips, test strip vials and boxes | ||
Patent #
US 8,358,210 B2
Filed 11/24/2009
|
Current Assignee
Therasense Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring system and methods | ||
Patent #
US 8,362,904 B2
Filed 04/18/2011
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensors having a signal-to-noise ratio substantially unaffected by non-constant noise | ||
Patent #
US 8,364,229 B2
Filed 05/18/2007
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,366,614 B2
Filed 03/30/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for providing data communication in continuous glucose monitoring and management system | ||
Patent #
US 8,368,556 B2
Filed 04/29/2010
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,372,005 B2
Filed 12/21/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor with lag compensation | ||
Patent #
US 8,374,668 B1
Filed 10/23/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for providing calibration of an analyte sensor in an analyte monitoring system | ||
Patent #
US 8,376,945 B2
Filed 11/23/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Closed loop control system with safety parameters and methods | ||
Patent #
US 8,377,031 B2
Filed 08/31/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,380,273 B2
Filed 04/11/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
RF tag on test strips, test strip vials and boxes | ||
Patent #
US 8,390,455 B2
Filed 11/24/2009
|
Current Assignee
Therasense Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,391,945 B2
Filed 03/17/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
System and methods for processing analyte sensor data | ||
Patent #
US 8,394,021 B2
Filed 10/01/2007
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte sensor | ||
Patent #
US 8,396,528 B2
Filed 03/25/2008
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,409,131 B2
Filed 03/07/2007
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Assessing measures of glycemic variability | ||
Patent #
US 8,409,093 B2
Filed 10/23/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Device and method for automatic data acquisition and/or detection | ||
Patent #
US 8,417,545 B2
Filed 02/17/2012
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Systems and methods for processing sensor data | ||
Patent #
US 8,417,312 B2
Filed 10/24/2008
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Dual electrode system for a continuous analyte sensor | ||
Patent #
US 8,423,114 B2
Filed 10/01/2007
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and apparatus for providing dynamic multi-stage amplification in a medical device | ||
Patent #
US 8,427,298 B2
Filed 04/02/2012
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Calibration techniques for a continuous analyte sensor | ||
Patent #
US 8,428,678 B2
Filed 05/16/2012
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 8,444,560 B2
Filed 05/14/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring system and methods | ||
Patent #
US 8,456,301 B2
Filed 05/08/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 8,457,708 B2
Filed 12/05/2008
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte monitoring system and methods | ||
Patent #
US 8,461,985 B2
Filed 05/08/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,465,425 B2
Filed 06/30/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,473,021 B2
Filed 07/31/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor with time lag compensation | ||
Patent #
US 8,473,022 B2
Filed 01/30/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 8,475,373 B2
Filed 07/17/2008
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and apparatus for providing analyte monitoring system calibration accuracy | ||
Patent #
US 8,478,557 B2
Filed 07/30/2010
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,480,580 B2
Filed 04/19/2007
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 8,483,791 B2
Filed 04/11/2008
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte sensor subassembly and methods and apparatuses for inserting an analyte sensor associated with same | ||
Patent #
US 8,483,792 B2
Filed 03/17/2009
|
Current Assignee
WaveForm Technologies Inc.
|
Original Assignee
Isense Corporation
|
Method and system for providing real time analyte sensor calibration with retrospective backfill | ||
Patent #
US 8,483,967 B2
Filed 04/28/2010
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for determining analyte levels | ||
Patent #
US 8,484,005 B2
Filed 03/19/2012
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring system having an alert | ||
Patent #
US 8,497,777 B2
Filed 04/15/2010
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for providing continuous calibration of implantable analyte sensors | ||
Patent #
US 8,506,482 B2
Filed 02/07/2011
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Close proximity communication device and methods | ||
Patent #
US 8,509,107 B2
Filed 11/01/2010
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Sensor head for use with implantable devices | ||
Patent #
US 8,509,871 B2
Filed 10/28/2008
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Glucose measuring device for use in personal area network | ||
Patent #
US 8,512,239 B2
Filed 04/20/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for dynamically updating calibration parameters for an analyte sensor | ||
Patent #
US 8,515,517 B2
Filed 09/30/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Displays for a medical device | ||
Patent #
US 8,514,086 B2
Filed 08/30/2010
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 8,515,519 B2
Filed 02/26/2009
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Device and method for determining analyte levels | ||
Patent #
US 8,527,025 B1
Filed 11/22/1999
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and device for providing offset model based calibration for analyte sensor | ||
Patent #
US 8,532,935 B2
Filed 07/16/2012
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Glucose measurement device and methods using RFID | ||
Patent #
US 8,542,122 B2
Filed 01/17/2013
|
Current Assignee
Therasense Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Silicone based membranes for use in implantable glucose sensors | ||
Patent #
US 8,543,184 B2
Filed 10/20/2011
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 8,560,038 B2
Filed 05/14/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Particle-containing membrane and particulate electrode for analyte sensors | ||
Patent #
US 8,560,039 B2
Filed 09/17/2009
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 8,565,848 B2
Filed 05/07/2009
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 8,571,808 B2
Filed 01/23/2012
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Polymer membranes for continuous analyte sensors | ||
Patent #
US 8,583,204 B2
Filed 03/05/2010
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte sensor calibration management | ||
Patent #
US 8,583,205 B2
Filed 04/16/2010
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for providing basal profile modification in analyte monitoring and management systems | ||
Patent #
US 8,585,591 B2
Filed 07/10/2010
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring system and methods | ||
Patent #
US 8,593,287 B2
Filed 07/20/2012
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for powering an electronic device | ||
Patent #
US 8,593,109 B2
Filed 11/03/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Health management devices and methods | ||
Patent #
US 8,597,188 B2
Filed 06/20/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,597,189 B2
Filed 03/03/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring devices and methods therefor | ||
Patent #
US 8,597,575 B2
Filed 07/23/2012
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 8,600,681 B2
Filed 05/14/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,612,159 B2
Filed 02/16/2004
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 8,612,163 B2
Filed 08/30/2012
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor | ||
Patent #
US 8,615,282 B2
Filed 02/22/2006
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Health monitor | ||
Patent #
US 8,617,069 B2
Filed 06/20/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,617,071 B2
Filed 06/21/2007
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Continuous glucose monitoring system and methods of use | ||
Patent #
US 8,622,903 B2
Filed 05/25/2012
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
System and methods for processing analyte sensor data | ||
Patent #
US 8,622,905 B2
Filed 12/11/2009
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,622,906 B2
Filed 12/21/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Variable rate closed loop control and methods | ||
Patent #
US 8,622,988 B2
Filed 08/31/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for evaluating analyte sensor response characteristics | ||
Patent #
US 8,635,046 B2
Filed 06/22/2011
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,641,619 B2
Filed 12/21/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Glucose measuring device for use in personal area network | ||
Patent #
US 8,647,269 B2
Filed 04/20/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,649,841 B2
Filed 04/03/2007
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,652,043 B2
Filed 07/20/2012
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,660,627 B2
Filed 03/17/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 8,663,109 B2
Filed 03/29/2010
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and device for determining elapsed sensor life | ||
Patent #
US 8,665,091 B2
Filed 06/30/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,666,469 B2
Filed 11/16/2007
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,668,645 B2
Filed 01/03/2003
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,670,815 B2
Filed 04/30/2007
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,672,844 B2
Filed 02/27/2004
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
System and methods for processing analyte sensor data | ||
Patent #
US 8,676,287 B2
Filed 12/11/2009
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Device and method for determining analyte levels | ||
Patent #
US 8,676,288 B2
Filed 06/22/2011
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Device and method for automatic data acquisition and/or detection | ||
Patent #
US 8,676,601 B2
Filed 04/08/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 8,682,615 B2
Filed 08/04/2012
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Polymer membranes for continuous analyte sensors | ||
Patent #
US 8,682,408 B2
Filed 03/05/2010
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method of calibrating an analyte-measurement device, and associated methods, devices and systems | ||
Patent #
US 8,684,930 B2
Filed 06/29/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,688,188 B2
Filed 06/30/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 8,690,775 B2
Filed 04/11/2008
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and apparatus for providing dynamic multi-stage signal amplification in a medical device | ||
Patent #
US 8,698,615 B2
Filed 04/22/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
System and methods for processing analyte sensor data | ||
Patent #
US 8,700,117 B2
Filed 12/08/2009
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Mitigating single point failure of devices in an analyte monitoring system and methods thereof | ||
Patent #
US 8,710,993 B2
Filed 11/21/2012
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor calibration management | ||
Patent #
US 8,718,739 B2
Filed 12/28/2012
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing analyte monitoring system calibration accuracy | ||
Patent #
US 8,718,965 B2
Filed 06/24/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method, system and computer program product for real-time detection of sensitivity decline in analyte sensors | ||
Patent #
US 8,718,958 B2
Filed 03/12/2012
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated, University of Virginia Patent Foundation
|
Transcutaneous analyte sensor | ||
Patent #
US 8,721,545 B2
Filed 03/22/2010
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte monitoring system having an alert | ||
Patent #
US 8,730,058 B2
Filed 07/29/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,734,348 B2
Filed 03/17/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Closed loop control with improved alarm functions | ||
Patent #
US 8,734,422 B2
Filed 08/31/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,734,346 B2
Filed 04/30/2007
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Close proximity communication device and methods | ||
Patent #
US 8,737,259 B2
Filed 08/05/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,738,109 B2
Filed 03/03/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Optimizing analyte sensor calibration | ||
Patent #
US 8,744,547 B2
Filed 07/09/2012
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Cellulosic-based resistance domain for an analyte sensor | ||
Patent #
US 8,744,546 B2
Filed 04/28/2006
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,744,545 B2
Filed 03/03/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor | ||
Patent #
US 8,750,955 B2
Filed 11/02/2009
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Blood glucose tracking apparatus | ||
Patent #
US 8,765,059 B2
Filed 10/27/2010
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for providing data communication in continuous glucose monitoring and management system | ||
Patent #
US 8,771,183 B2
Filed 02/16/2005
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,774,887 B2
Filed 03/24/2007
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
System and methods for processing analyte sensor data | ||
Patent #
US 8,788,006 B2
Filed 12/11/2009
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 8,788,007 B2
Filed 03/08/2012
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 8,792,953 B2
Filed 03/19/2010
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Robust closed loop control and methods | ||
Patent #
US 8,795,252 B2
Filed 10/16/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 8,801,611 B2
Filed 03/22/2010
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Transcutaneous medical device with variable stiffness | ||
Patent #
US 8,812,072 B2
Filed 04/17/2008
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Displays for a medical device | ||
Patent #
US 8,816,862 B2
Filed 08/19/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensors and methods of manufacturing same | ||
Patent #
US 8,828,201 B2
Filed 07/01/2010
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and apparatus for providing analyte sensor calibration | ||
Patent #
US 8,834,366 B2
Filed 07/31/2007
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,840,553 B2
Filed 02/26/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Techniques to improve polyurethane membranes for implantable glucose sensors | ||
Patent #
US 8,865,249 B2
Filed 09/28/2012
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,880,137 B2
Filed 04/18/2003
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor | ||
Patent #
US 8,886,272 B2
Filed 02/22/2006
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte sensor | ||
Patent #
US 8,900,431 B2
Filed 08/25/2009
|
Current Assignee
Edwards Lifesciences Corporation
|
Original Assignee
Edwards Lifesciences Corporation
|
Oxygen enhancing membrane systems for implantable devices | ||
Patent #
US 8,909,314 B2
Filed 07/20/2011
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Dual electrode system for a continuous analyte sensor | ||
Patent #
US 8,911,369 B2
Filed 12/15/2008
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 8,915,849 B2
Filed 02/03/2009
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,915,850 B2
Filed 03/28/2014
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,920,319 B2
Filed 12/28/2012
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for powering an electronic device | ||
Patent #
US 8,933,664 B2
Filed 11/25/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing dynamic multi-stage signal amplification in a medical device | ||
Patent #
US 8,937,540 B2
Filed 02/24/2014
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Polymer membranes for continuous analyte sensors | ||
Patent #
US 8,954,128 B2
Filed 10/18/2013
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,974,386 B2
Filed 11/01/2005
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor sensitivity attenuation mitigation | ||
Patent #
US 8,986,208 B2
Filed 09/30/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring system and methods for managing power and noise | ||
Patent #
US 8,993,331 B2
Filed 08/31/2010
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring system and methods | ||
Patent #
US 9,000,929 B2
Filed 11/22/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing data processing and control in medical communication system | ||
Patent #
US 9,008,743 B2
Filed 04/14/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 9,011,332 B2
Filed 10/30/2007
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 9,011,331 B2
Filed 12/29/2004
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 9,014,773 B2
Filed 03/07/2007
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring system and methods | ||
Patent #
US 9,035,767 B2
Filed 05/30/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Receivers for analyzing and displaying sensor data | ||
Patent #
US 9,041,730 B2
Filed 02/11/2011
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte monitoring devices and methods therefor | ||
Patent #
US 9,039,975 B2
Filed 12/02/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 9,042,953 B2
Filed 03/02/2007
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 9,044,199 B2
Filed 03/10/2005
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and apparatus for detecting false hypoglycemic conditions | ||
Patent #
US 9,050,041 B2
Filed 05/21/2012
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 9,055,901 B2
Filed 09/14/2012
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 9,060,719 B2
Filed 12/13/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 9,066,695 B2
Filed 04/12/2007
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 9,066,697 B2
Filed 10/27/2011
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Electronic devices having integrated reset systems and methods thereof | ||
Patent #
US 9,069,536 B2
Filed 10/30/2012
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 9,066,694 B2
Filed 04/03/2007
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 9,072,477 B2
Filed 06/21/2007
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 9,078,626 B2
Filed 03/31/2011
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 9,078,607 B2
Filed 06/17/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for providing data communication in continuous glucose monitoring and management system | ||
Patent #
US 9,088,452 B2
Filed 01/31/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing rolling data in communication systems | ||
Patent #
US 9,095,290 B2
Filed 02/27/2012
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for providing analyte monitoring | ||
Patent #
US 9,113,828 B2
Filed 07/09/2012
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 9,125,548 B2
Filed 05/14/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensors and methods of manufacturing same | ||
Patent #
US 9,131,885 B2
Filed 07/01/2010
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Low oxygen in vivo analyte sensor | ||
Patent #
US 9,155,496 B2
Filed 02/18/2011
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Polymer membranes for continuous analyte sensors | ||
Patent #
US 9,173,607 B2
Filed 01/30/2014
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte monitoring system and methods | ||
Patent #
US 9,177,456 B2
Filed 06/10/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring system having an alert | ||
Patent #
US 9,178,752 B2
Filed 04/25/2014
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Polymer membranes for continuous analyte sensors | ||
Patent #
US 9,173,606 B2
Filed 01/30/2014
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Techniques to improve polyurethane membranes for implantable glucose sensors | ||
Patent #
US 9,179,869 B2
Filed 09/10/2014
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Close proximity communication device and methods | ||
Patent #
US 9,184,875 B2
Filed 04/25/2014
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Displays for a medical device | ||
Patent #
US 9,186,113 B2
Filed 08/11/2014
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing data processing and control in medical communication system | ||
Patent #
US 9,204,827 B2
Filed 04/14/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Displays for a medical device | ||
Patent #
US 9,226,714 B2
Filed 01/08/2015
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Error detection in critical repeating data in a wireless sensor system | ||
Patent #
US 9,226,701 B2
Filed 04/28/2010
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensors and methods of manufacturing same | ||
Patent #
US 9,237,864 B2
Filed 07/01/2010
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte sensor | ||
Patent #
US 9,247,900 B2
Filed 06/04/2013
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Mitigating single point failure of devices in an analyte monitoring system and methods thereof | ||
Patent #
US 9,289,179 B2
Filed 04/11/2014
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for providing real time analyte sensor calibration with retrospective backfill | ||
Patent #
US 9,310,230 B2
Filed 06/24/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Compatibility mechanisms for devices in a continuous analyte monitoring system and methods thereof | ||
Patent #
US 9,317,656 B2
Filed 11/21/2012
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring system and methods | ||
Patent #
US 9,314,198 B2
Filed 04/03/2015
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte signal processing device and methods | ||
Patent #
US 9,314,195 B2
Filed 08/31/2010
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor calibration management | ||
Patent #
US 9,320,462 B2
Filed 05/05/2014
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for providing basal profile modification in analyte monitoring and management systems | ||
Patent #
US 9,323,898 B2
Filed 11/15/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor | ||
Patent #
US 9,320,466 B2
Filed 10/18/2013
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte sensor with time lag compensation | ||
Patent #
US 9,320,468 B2
Filed 06/21/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Systems, devices and methods for managing glucose levels | ||
Patent #
US 9,326,709 B2
Filed 03/09/2011
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 9,326,716 B2
Filed 12/05/2014
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Sensor head for use with implantable devices | ||
Patent #
US 9,328,371 B2
Filed 07/16/2013
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 9,326,714 B2
Filed 06/29/2010
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Alarm characterization for analyte monitoring devices and systems | ||
Patent #
US 9,326,707 B2
Filed 11/10/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor with lag compensation | ||
Patent #
US 9,332,934 B2
Filed 02/08/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Device and method for determining analyte levels | ||
Patent #
US 9,339,223 B2
Filed 12/30/2013
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Particle-containing membrane and particulate electrode for analyte sensors | ||
Patent #
US 9,339,222 B2
Filed 05/31/2013
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte monitoring system and methods of use | ||
Patent #
US 9,339,217 B2
Filed 11/21/2012
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor with increased reference capacity | ||
Patent #
US 9,351,677 B2
Filed 03/04/2013
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 9,357,951 B2
Filed 09/29/2010
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and system for dynamically updating calibration parameters for an analyte sensor | ||
Patent #
US 9,357,959 B2
Filed 08/19/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor transmitter unit configuration for a data monitoring and management system | ||
Patent #
US 9,364,149 B2
Filed 10/03/2011
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for powering an electronic device | ||
Patent #
US 9,380,971 B2
Filed 12/05/2014
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Closed loop control and signal attenuation detection | ||
Patent #
US 9,392,969 B2
Filed 08/31/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing analyte sensor calibration | ||
Patent #
US 9,398,872 B2
Filed 08/28/2014
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing dynamic multi-stage signal amplification in a medical device | ||
Patent #
US 9,402,584 B2
Filed 01/14/2015
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for providing calibration of an analyte sensor in an analyte monitoring system | ||
Patent #
US 9,408,566 B2
Filed 02/13/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 9,414,777 B2
Filed 03/10/2005
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Assessing measures of glycemic variability | ||
Patent #
US 9,439,586 B2
Filed 03/29/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Device and method for determining analyte levels | ||
Patent #
US 9,439,589 B2
Filed 11/25/2014
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 9,451,910 B2
Filed 08/27/2010
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte sensor | ||
Patent #
US 9,451,908 B2
Filed 12/19/2012
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Electronic devices having integrated reset systems and methods thereof | ||
Patent #
US 9,465,420 B2
Filed 06/26/2015
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Multi-rate analyte sensor data collection with sample rate configurable signal processing | ||
Patent #
US 9,474,475 B1
Filed 03/13/2014
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Blood glucose tracking apparatus and methods | ||
Patent #
US 9,477,811 B2
Filed 06/23/2005
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 9,483,608 B2
Filed 05/20/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 9,498,159 B2
Filed 10/30/2007
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Receivers for analyzing and displaying sensor data | ||
Patent #
US 9,498,164 B2
Filed 12/05/2013
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Receivers for analyzing and displaying sensor data | ||
Patent #
US 9,498,165 B2
Filed 12/05/2013
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Dual electrode system for a continuous analyte sensor | ||
Patent #
US 9,504,413 B2
Filed 04/15/2013
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Receivers for analyzing and displaying sensor data | ||
Patent #
US 9,504,430 B2
Filed 12/05/2013
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte sensor with increased reference capacity | ||
Patent #
US 9,517,025 B2
Filed 05/12/2016
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte sensor retention mechanism and methods of use | ||
Patent #
US 9,521,968 B2
Filed 09/30/2005
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Devices, systems, and methods associated with analyte monitoring devices and devices incorporating the same | ||
Patent #
US 9,532,737 B2
Filed 02/28/2012
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Displays for a medical device | ||
Patent #
US 9,549,694 B2
Filed 11/11/2015
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Silicone based membranes for use in implantable glucose sensors | ||
Patent #
US 9,549,693 B2
Filed 07/25/2013
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Polymer membranes for continuous analyte sensors | ||
Patent #
US 9,549,699 B2
Filed 10/17/2014
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and system for determining analyte levels | ||
Patent #
US 9,558,325 B2
Filed 06/24/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Polymer membranes for continuous analyte sensors | ||
Patent #
US 9,566,026 B2
Filed 10/17/2014
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Robust closed loop control and methods | ||
Patent #
US 9,572,934 B2
Filed 08/01/2014
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Polymer membranes for continuous analyte sensors | ||
Patent #
US 9,572,523 B2
Filed 09/22/2015
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and device for determining elapsed sensor life | ||
Patent #
US 9,574,914 B2
Filed 03/03/2014
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Dual electrode system for a continuous analyte sensor | ||
Patent #
US 9,579,053 B2
Filed 03/26/2010
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Oxygen enhancing membrane systems for implantable devices | ||
Patent #
US 9,597,027 B2
Filed 10/30/2014
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 9,610,034 B2
Filed 11/09/2015
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 9,610,031 B2
Filed 04/13/2011
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Closed loop control with improved alarm functions | ||
Patent #
US 9,610,046 B2
Filed 04/29/2014
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing data processing and control in medical communication system | ||
Patent #
US 9,615,780 B2
Filed 04/14/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Model based variable risk false glucose threshold alarm prevention mechanism | ||
Patent #
US 9,622,691 B2
Filed 10/30/2012
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring devices and methods therefor | ||
Patent #
US 9,625,413 B2
Filed 05/19/2015
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for dynamically updating calibration parameters for an analyte sensor | ||
Patent #
US 9,629,578 B2
Filed 03/26/2016
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring system and methods | ||
Patent #
US 9,649,057 B2
Filed 05/11/2015
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Optimizing analyte sensor calibration | ||
Patent #
US 9,662,056 B2
Filed 05/22/2014
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor | ||
Patent #
US 9,668,677 B2
Filed 10/26/2015
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 9,668,682 B2
Filed 12/18/2014
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and system for providing basal profile modification in analyte monitoring and management systems | ||
Patent #
US 9,669,162 B2
Filed 03/16/2016
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Sensitivity calibration of in vivo sensors used to measure analyte concentration | ||
Patent #
US 9,675,290 B2
Filed 10/29/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for providing data communication in continuous glucose monitoring and management system | ||
Patent #
US 9,693,688 B2
Filed 07/16/2015
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Polymer membranes for continuous analyte sensors | ||
Patent #
US 9,693,721 B2
Filed 06/17/2015
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Systems and methods for processing sensor data | ||
Patent #
US 9,717,449 B2
Filed 01/15/2013
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte sensor | ||
Patent #
US 9,724,028 B2
Filed 11/24/2014
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Glucose measuring device for use in personal area network | ||
Patent #
US 9,730,584 B2
Filed 02/10/2014
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor calibration management | ||
Patent #
US 9,730,623 B2
Filed 02/05/2016
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Alarm characterization for analyte monitoring devices and systems | ||
Patent #
US 9,730,650 B2
Filed 01/15/2016
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 9,737,249 B2
Filed 06/17/2015
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing dynamic multi-stage signal amplification in a medical device | ||
Patent #
US 9,743,866 B2
Filed 07/13/2016
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for powering an electronic device | ||
Patent #
US 9,743,863 B2
Filed 06/01/2016
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Assessing measures of glycemic variability | ||
Patent #
US 9,743,865 B2
Filed 06/25/2016
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Mitigating single point failure of devices in an analyte monitoring system and methods thereof | ||
Patent #
US 9,743,872 B2
Filed 02/04/2016
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Interconnect for on-body analyte monitoring device | ||
Patent #
US 9,750,444 B2
Filed 04/27/2016
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Low oxygen in vivo analyte sensor | ||
Patent #
US 9,757,061 B2
Filed 09/01/2015
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte sensors and methods of manufacturing same | ||
Patent #
US 9,763,608 B2
Filed 12/04/2015
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte sensors having a signal-to-noise ratio substantially unaffected by non-constant noise | ||
Patent #
US 9,763,609 B2
Filed 01/02/2013
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte sensor with time lag compensation | ||
Patent #
US 9,770,211 B2
Filed 04/08/2016
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 9,775,543 B2
Filed 12/30/2013
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and apparatus for providing analyte sensor insertion | ||
Patent #
US 9,795,331 B2
Filed 04/28/2016
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 9,797,880 B2
Filed 10/11/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Techniques to improve polyurethane membranes for implantable glucose sensors | ||
Patent #
US 9,801,574 B2
Filed 10/05/2015
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and apparatus for providing rolling data in communication systems | ||
Patent #
US 9,801,545 B2
Filed 07/30/2015
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing data processing and control in medical communication system | ||
Patent #
US 9,801,571 B2
Filed 09/16/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Sensitivity calibration of in vivo sensors used to measure analyte concentration | ||
Patent #
US 9,801,577 B2
Filed 06/07/2017
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 9,804,150 B2
Filed 03/24/2014
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor with lag compensation | ||
Patent #
US 9,804,148 B2
Filed 04/29/2016
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Sensor head for use with implantable devices | ||
Patent #
US 9,804,114 B2
Filed 03/02/2016
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Displays for a medical device | ||
Patent #
US 9,814,416 B2
Filed 12/13/2016
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for providing analyte monitoring | ||
Patent #
US 9,814,428 B2
Filed 08/22/2015
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 9,814,414 B2
Filed 03/30/2010
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Close proximity communication device and methods | ||
Patent #
US 9,831,985 B2
Filed 09/29/2015
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for providing calibration of an analyte sensor in an analyte monitoring system | ||
Patent #
US 9,833,181 B2
Filed 07/13/2016
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Receivers for analyzing and displaying sensor data | ||
Patent #
US 9,833,199 B2
Filed 05/19/2015
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and system for dynamically updating calibration parameters for an analyte sensor | ||
Patent #
US 9,839,383 B2
Filed 04/21/2017
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method, system and computer program product for real-time detection of sensitivity decline in analyte sensors | ||
Patent #
US 9,882,660 B2
Filed 04/30/2014
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated, University of Virginia Patent Foundation
|
Analyte sensor | ||
Patent #
US 9,907,497 B2
Filed 10/18/2013
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and apparatus for improving lag correction during in vivo measurement of analyte concentration with analyte concentration variability and range data | ||
Patent #
US 9,907,492 B2
Filed 09/18/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Model based variable risk false glucose threshold alarm prevention mechanism | ||
Patent #
US 9,913,619 B2
Filed 04/13/2017
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Device and method for determining analyte levels | ||
Patent #
US 9,931,067 B2
Filed 09/13/2016
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Closed loop control with reference measurement and methods thereof | ||
Patent #
US 9,943,644 B2
Filed 08/31/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for providing data communication in continuous glucose monitoring and management system | ||
Patent #
US 9,949,639 B2
Filed 06/27/2017
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and device for determining elapsed sensor life | ||
Patent #
US 9,949,678 B2
Filed 02/16/2017
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Continuous glucose monitoring system and methods of use | ||
Patent #
US 9,962,091 B2
Filed 01/06/2014
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte signal processing device and methods | ||
Patent #
US 9,968,302 B2
Filed 04/04/2016
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Methods and apparatuses for providing adverse condition notification with enhanced wireless communication range in analyte monitoring systems | ||
Patent #
US 9,968,306 B2
Filed 10/21/2014
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods | ||
Patent #
US 9,980,669 B2
Filed 11/07/2012
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor | ||
Patent #
US 9,986,942 B2
Filed 08/10/2006
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Oxygen enhancing membrane systems for implantable devices | ||
Patent #
US 9,993,186 B2
Filed 02/09/2017
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 10,002,233 B2
Filed 05/14/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring system having an alert | ||
Patent #
US 10,009,244 B2
Filed 10/30/2015
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor | ||
Patent #
US 10,022,078 B2
Filed 05/23/2006
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Device and method for automatic data acquisition and/or detection | ||
Patent #
US 10,022,499 B2
Filed 08/18/2015
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Particle-containing membrane and particulate electrode for analyte sensors | ||
Patent #
US 10,028,683 B2
Filed 10/07/2014
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Particle-containing membrane and particulate electrode for analyte sensors | ||
Patent #
US 10,028,684 B2
Filed 09/21/2017
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 10,031,002 B2
Filed 12/02/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for providing data communication in continuous glucose monitoring and management system | ||
Patent #
US 10,039,881 B2
Filed 07/07/2014
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor sensitivity attenuation mitigation | ||
Patent #
US 10,045,739 B2
Filed 03/23/2015
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 10,045,720 B2
Filed 10/15/2016
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Silicone based membranes for use in implantable glucose sensors | ||
Patent #
US 10,052,051 B2
Filed 10/27/2017
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Sensor fault detection using analyte sensor data pattern comparison | ||
Patent #
US 10,076,285 B2
Filed 03/13/2014
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring system and methods of use | ||
Patent #
US 10,082,493 B2
Filed 04/29/2016
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and device for providing offset model based calibration for analyte sensor | ||
Patent #
US 10,089,446 B2
Filed 09/03/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Calibration of analyte measurement system | ||
Patent #
US 10,092,229 B2
Filed 06/29/2011
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing data processing and control in medical communication system | ||
Patent #
US 10,111,608 B2
Filed 04/14/2008
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for providing continuous calibration of implantable analyte sensors | ||
Patent #
US 10,117,614 B2
Filed 09/11/2015
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for detecting false hypoglycemic conditions | ||
Patent #
US 10,117,606 B2
Filed 06/03/2015
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 10,119,956 B2
Filed 10/27/2017
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Displays for a medical device | ||
Patent #
US 10,123,752 B2
Filed 11/10/2017
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Dropout detection in continuous analyte monitoring data during data excursions | ||
Patent #
US 10,132,793 B2
Filed 08/20/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Dual electrode system for a continuous analyte sensor | ||
Patent #
US 10,136,844 B2
Filed 11/18/2016
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Medical devices and methods | ||
Patent #
US 10,136,816 B2
Filed 08/31/2010
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Mitigating single point failure of devices in an analyte monitoring system and methods thereof | ||
Patent #
US 10,136,847 B2
Filed 08/24/2017
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 10,143,409 B2
Filed 10/27/2017
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Polymer membranes for continuous analyte sensors | ||
Patent #
US 10,143,410 B2
Filed 06/01/2017
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Techniques to improve polyurethane membranes for implantable glucose sensors | ||
Patent #
US 10,154,807 B2
Filed 09/27/2017
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte sensor transmitter unit configuration for a data monitoring and management system | ||
Patent #
US 10,159,433 B2
Filed 04/18/2016
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Receivers for analyzing and displaying sensor data | ||
Patent #
US 10,165,986 B2
Filed 10/26/2016
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and system for providing data communication in continuous glucose monitoring and management system | ||
Patent #
US 10,172,518 B2
Filed 04/13/2018
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Closed loop control system with safety parameters and methods | ||
Patent #
US 10,173,007 B2
Filed 02/13/2013
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring system and methods | ||
Patent #
US 10,178,954 B2
Filed 05/09/2017
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Systems and methods for processing sensor data | ||
Patent #
US 10,182,751 B2
Filed 06/26/2017
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Sensitivity calibration of in vivo sensors used to measure analyte concentration | ||
Patent #
US 10,188,334 B2
Filed 10/20/2017
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing dynamic multi-stage signal amplification in a medical device | ||
Patent #
US 10,194,846 B2
Filed 08/25/2017
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and system for providing analyte monitoring | ||
Patent #
US 10,194,868 B2
Filed 11/10/2017
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 10,201,301 B2
Filed 04/18/2016
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte monitoring device and methods of use | ||
Patent #
US 10,231,654 B2
Filed 06/23/2015
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Displays for a medical device | ||
Patent #
US RE47,315 E1
Filed 06/30/2016
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 10,261,069 B2
Filed 10/20/2017
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Low oxygen in vivo analyte sensor | ||
Patent #
US 10,265,000 B2
Filed 08/03/2017
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Receivers for analyzing and displaying sensor data | ||
Patent #
US 10,265,030 B2
Filed 12/17/2015
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and system for providing calibration of an analyte sensor in an analyte monitoring system | ||
Patent #
US 10,278,630 B2
Filed 11/30/2017
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Receivers for analyzing and displaying sensor data | ||
Patent #
US 10,278,650 B2
Filed 12/16/2015
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Dual electrode system for a continuous analyte sensor | ||
Patent #
US 10,299,712 B2
Filed 09/05/2017
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Cellulosic-based resistance domain for an analyte sensor | ||
Patent #
US 10,300,507 B2
Filed 02/14/2014
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and apparatus for providing analyte sensor insertion | ||
Patent #
US 10,307,091 B2
Filed 10/20/2017
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor | ||
Patent #
US 10,314,525 B2
Filed 01/06/2015
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and system for dynamically updating calibration parameters for an analyte sensor | ||
Patent #
US 10,342,469 B2
Filed 12/08/2017
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Dropout detection in continuous analyte monitoring data during data excursions | ||
Patent #
US 10,345,291 B2
Filed 11/16/2018
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing data processing and control in medical communication system | ||
Patent #
US 10,349,877 B2
Filed 04/03/2015
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor | ||
Patent #
US 10,349,873 B2
Filed 04/27/2016
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Fitness training system with energy expenditure calculation that uses multiple sensor inputs | ||
Patent #
US 10,369,412 B2
Filed 12/14/2016
|
Current Assignee
Nike Inc.
|
Original Assignee
Nike Inc.
|
Analyte sensors having a signal-to-noise ratio substantially unaffected by non-constant noise | ||
Patent #
US 10,376,143 B2
Filed 12/31/2013
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte monitoring system and methods for managing power and noise | ||
Patent #
US 10,429,250 B2
Filed 03/26/2015
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Noise rejection methods and apparatus for sparsely sampled analyte sensor data | ||
Patent #
US 10,433,773 B1
Filed 03/13/2014
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Displays for a medical device | ||
Patent #
US 10,456,091 B2
Filed 11/05/2018
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor calibration management | ||
Patent #
US 10,463,288 B2
Filed 08/11/2017
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 10,463,310 B2
Filed 09/07/2015
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensor with increased reference capacity | ||
Patent #
US 10,470,691 B2
Filed 12/06/2016
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Subcutaneous device for monitoring and/or providing therapies | ||
Patent #
US 10,471,251 B1
Filed 07/31/2018
|
Current Assignee
Calyan Technologies Inc.
|
Original Assignee
Manicka Institute LLC
|
Analyte monitoring device and methods of use | ||
Patent #
US 10,478,108 B2
Filed 02/05/2016
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Medical devices and methods | ||
Patent #
US 10,492,685 B2
Filed 08/31/2015
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 10,524,703 B2
Filed 01/24/2014
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Advanced analyte sensor calibration and error detection | ||
Patent #
US 10,555,695 B2
Filed 07/02/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Systems and methods for display device and sensor electronics unit communication | ||
Patent #
US 10,561,349 B2
Filed 03/28/2017
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Particle-containing membrane and particulate electrode for analyte sensors | ||
Patent #
US 10,561,352 B2
Filed 07/03/2018
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Advanced analyte sensor calibration and error detection | ||
Patent #
US 10,561,354 B2
Filed 07/02/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Systems and methods for display device and sensor electronics unit communication | ||
Patent #
US 10,568,552 B2
Filed 03/28/2017
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Injectable subcutaneous device | ||
Patent #
US 10,569,093 B1
Filed 03/15/2019
|
Current Assignee
Calyan Technologies Inc.
|
Original Assignee
Manicka Institute LLC
|
Subcutaneous device for monitoring and/or providing therapies | ||
Patent #
US 10,569,078 B1
Filed 03/15/2019
|
Current Assignee
Calyan Technologies Inc.
|
Original Assignee
Manicka Institute LLC
|
Subcutaneous device | ||
Patent #
US 10,576,291 B2
Filed 07/31/2018
|
Current Assignee
Calyan Technologies Inc.
|
Original Assignee
Manicka Institute LLC
|
Analyte sensor | ||
Patent #
US 10,602,968 B2
Filed 09/10/2014
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 10,610,103 B2
Filed 08/16/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
System and methods for processing analyte sensor data for sensor calibration | ||
Patent #
US 10,610,137 B2
Filed 06/28/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 10,610,102 B2
Filed 07/03/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
System and methods for processing analyte sensor data for sensor calibration | ||
Patent #
US 10,610,136 B2
Filed 06/28/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Oxygen enhancing membrane systems for implantable devices | ||
Patent #
US 10,610,140 B2
Filed 05/11/2018
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Advanced analyte sensor calibration and error detection | ||
Patent #
US 10,610,141 B2
Filed 09/27/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
System and methods for processing analyte sensor data for sensor calibration | ||
Patent #
US 10,610,135 B2
Filed 06/28/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and system for providing data communication in continuous glucose monitoring and management system | ||
Patent #
US 10,617,296 B2
Filed 01/07/2019
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
System and methods for processing analyte sensor data for sensor calibration | ||
Patent #
US 10,617,336 B2
Filed 06/28/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Device and method for automatic data acquisition and/or detection | ||
Patent #
US 10,617,823 B2
Filed 06/27/2018
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 10,624,539 B2
Filed 07/03/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Advanced analyte sensor calibration and error detection | ||
Patent #
US 10,624,568 B2
Filed 08/13/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 10,634,662 B2
Filed 11/05/2018
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Subcutaneous device | ||
Patent #
US 10,639,483 B2
Filed 08/30/2019
|
Current Assignee
Calyan Technologies Inc.
|
Original Assignee
Manicka Institute LLC
|
Injectable subcutaneous device | ||
Patent #
US 10,646,721 B2
Filed 07/31/2018
|
Current Assignee
Calyan Technologies Inc.
|
Original Assignee
Manicka Institute LLC
|
Analyte monitoring system and methods | ||
Patent #
US 10,653,317 B2
Filed 01/10/2019
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 10,653,344 B2
Filed 11/19/2018
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Dropout detection in continuous analyte monitoring data during data excursions | ||
Patent #
US 10,656,139 B2
Filed 07/08/2019
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 10,667,733 B2
Filed 12/14/2015
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Advanced analyte sensor calibration and error detection | ||
Patent #
US 10,682,084 B2
Filed 05/07/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Insulin delivery apparatuses capable of bluetooth data transmission | ||
Patent #
US 10,685,749 B2
Filed 12/28/2015
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
System and methods for processing analyte sensor data for sensor calibration | ||
Patent #
US 10,709,364 B2
Filed 11/21/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 10,709,332 B2
Filed 08/16/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte sensor | ||
Patent #
US 10,709,362 B2
Filed 11/21/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte sensor | ||
Patent #
US 10,709,363 B2
Filed 11/21/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
System and methods for processing analyte sensor data for sensor calibration | ||
Patent #
US 10,716,498 B2
Filed 11/21/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Subcutaneous device for monitoring and/or providing therapies | ||
Patent #
US 10,716,511 B2
Filed 11/11/2019
|
Current Assignee
Calyan Technologies Inc.
|
Original Assignee
Manicka Institute LLC
|
Analyte sensor | ||
Patent #
US 10,722,152 B2
Filed 11/05/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Advanced analyte sensor calibration and error detection | ||
Patent #
US 10,722,162 B2
Filed 09/27/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
System and methods for processing analyte sensor data for sensor calibration | ||
Patent #
US 10,743,801 B2
Filed 11/21/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Continuous glucose monitoring system and methods of use | ||
Patent #
US 10,750,952 B2
Filed 03/26/2018
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Interconnect for on-body analyte monitoring device | ||
Patent #
US 10,765,351 B2
Filed 08/10/2017
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Displays for a medical device | ||
Patent #
US 10,772,572 B2
Filed 10/25/2019
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Analyte sensors having a signal-to-noise ratio substantially unaffected by non-constant noise | ||
Patent #
US 10,791,928 B2
Filed 02/20/2020
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte sensor | ||
Patent #
US 10,799,158 B2
Filed 11/21/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Systems and methods for display device and sensor electronics unit communication | ||
Patent #
US 10,799,157 B2
Filed 08/29/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte sensor | ||
Patent #
US 10,799,159 B2
Filed 02/13/2020
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte sensor | ||
Patent #
US 10,813,577 B2
Filed 02/13/2020
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte sensor | ||
Patent #
US 10,813,576 B2
Filed 11/21/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and apparatus for providing data processing and control in a medical communication system | ||
Patent #
US 10,820,841 B2
Filed 08/09/2018
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 10,835,161 B2
Filed 02/12/2016
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Advanced analyte sensor calibration and error detection | ||
Patent #
US 10,835,162 B2
Filed 09/27/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Method and apparatus for improving lag correction during in vivo measurement of analyte concentration with analyte concentration variability and range data | ||
Patent #
US 10,842,420 B2
Filed 03/02/2018
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Remote monitoring of analyte measurements | ||
Patent #
US 10,856,736 B2
Filed 03/26/2020
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
System and methods for processing analyte sensor data for sensor calibration | ||
Patent #
US 10,856,787 B2
Filed 07/31/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Remote monitoring of analyte measurements | ||
Patent #
US 10,860,687 B2
Filed 06/23/2017
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Remote monitoring of analyte measurements | ||
Patent #
US 10,869,599 B2
Filed 03/26/2020
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Multi-rate analyte sensor data collection with sample rate configurable signal processing | ||
Patent #
US 10,874,336 B2
Filed 10/12/2016
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Systems and methods for display device and sensor electronics unit communication | ||
Patent #
US 10,881,335 B2
Filed 08/29/2019
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Displays for a medical device | ||
Patent #
US 10,881,355 B2
Filed 06/15/2020
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Infusion set | ||
Patent #
US 7,879,010 B2
Filed 10/06/2003
|
Current Assignee
Roche Diabetes Care Inc.
|
Original Assignee
Roche Diagnostics International AG
|
Transcutaneous analyte sensor | ||
Patent #
US 7,885,697 B2
Filed 03/10/2005
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Transcutaneous analyte sensor | ||
Patent #
US 7,654,956 B2
Filed 03/10/2005
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
EQUILIBRIUM NON-CONSUMING FLUORESCENCE SENSOR FOR REAL TIME INTRAVASCULAR GLUCOSE MEASUREMENT | ||
Patent #
US 20090018418A1
Filed 05/09/2008
|
Current Assignee
Medtronic Minimed Incorporated
|
Original Assignee
GluMetrics Inc.
|
DEVICE AND METHODS FOR CALIBRATING ANALYTE SENSORS | ||
Patent #
US 20090018426A1
Filed 05/09/2008
|
Current Assignee
Medtronic Minimed Incorporated
|
Original Assignee
GluMetrics Inc.
|
Telemetered characteristic monitor system and method of using the same | ||
Patent #
US 7,324,012 B2
Filed 09/12/2005
|
Current Assignee
Medtronic Minimed Incorporated
|
Original Assignee
Medtronic Minimed Incorporated
|
Method and Apparatus for Providing Analyte Sensor Insertion | ||
Patent #
US 20080033268A1
Filed 09/28/2006
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Insertion device for an insertion set and method of using the same | ||
Patent #
US 7,329,239 B2
Filed 02/20/2003
|
Current Assignee
Medtronic Minimed Incorporated
|
Original Assignee
Medtronic Minimed Incorporated
|
Sensor inserter assembly | ||
Patent #
US 7,381,184 B2
Filed 11/05/2003
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Method and device for sampling and analyzing interstitial fluid and whole blood samples | ||
Patent #
US 20070017805A1
Filed 06/30/2006
|
Current Assignee
Lifescan Incorporated
|
Original Assignee
Lifescan Incorporated
|
Analyte sensor | ||
Patent #
US 20070038044A1
Filed 06/03/2006
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Optical fiber cable provided with stabilized waterblocking material | ||
Patent #
US 5,285,513 A
Filed 11/30/1992
|
Current Assignee
Furukawa Electric North America Incorporated
|
Original Assignee
ATT Inc.
|
Current collection through thermally sprayed tabs at the ends of a spirally wound electrochemical cell | ||
Patent #
US 6,187,062 B1
Filed 06/16/1998
|
Current Assignee
Saft Finance Sarl
|
Original Assignee
Alcatel-Lucent SA
|
Liquid handling device with surface features at a seal | ||
Patent #
US 20060008370A1
Filed 07/09/2004
|
Current Assignee
Protedyne Corporation
|
Original Assignee
Protedyne Corporation
|
Transcutaneous medical device with variable stiffness | ||
Patent #
US 20060015024A1
Filed 03/10/2005
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
TRANSCUTANEOUS ANALYTE SENSOR | ||
Patent #
US 20060020187A1
Filed 03/10/2005
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Methods and compositions for the inhibition of biofilms on medical devices | ||
Patent #
US 20050008671A1
Filed 07/10/2003
|
Current Assignee
Medtronic Minimed Incorporated
|
Original Assignee
Medtronic Minimed Incorporated
|
Fully implantable nerve signal sensing and stimulation device and method for treating foot drop and other neurological disorders | ||
Patent #
US 20050010265A1
Filed 04/02/2004
|
Current Assignee
4491343 Canada Inc.
|
Original Assignee
Neurostream Technologies G.P.
|
Systems and methods for replacing signal artifacts in a glucose sensor data stream | ||
Patent #
US 20050043598A1
Filed 08/22/2003
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Biointerface membranes incorporating bioactive agents | ||
Patent #
US 20050031689A1
Filed 05/10/2004
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Analyte measuring device | ||
Patent #
US 20050033132A1
Filed 05/14/2004
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
System and methods for processing analyte sensor data | ||
Patent #
US 20050027181A1
Filed 08/01/2003
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
System and methods for processing analyte sensor data | ||
Patent #
US 20050027180A1
Filed 08/01/2003
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
System and methods for processing analyte sensor data | ||
Patent #
US 20050027463A1
Filed 08/01/2003
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
System and methods for processing analyte sensor data | ||
Patent #
US 20050027462A1
Filed 08/01/2003
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Gas column pressure monitoring catheters | ||
Patent #
US 6,673,022 B1
Filed 07/18/2000
|
Current Assignee
IRRAS USA Inc.
|
Original Assignee
InnerSpace Medical Inc.
|
Drug delivery systems and methods | ||
Patent #
US 20040015134A1
Filed 07/14/2003
|
Current Assignee
Elan Pharma International Limited
|
Original Assignee
Elan Pharma International Limited
|
Transcutaneous sensor insertion device | ||
Patent #
US 6,695,860 B1
Filed 11/13/2000
|
Current Assignee
WaveForm Technologies Inc.
|
Original Assignee
Isense Corporation
|
Drug delivery systems and methods | ||
Patent #
US 20040030285A1
Filed 08/07/2003
|
Current Assignee
Elan Pharma International Limited
|
Original Assignee
Elan Pharma International Limited
|
Method and apparatus for real time display of filtered electrocardiogram data | ||
Patent #
US 20040024327A1
Filed 08/01/2002
|
Current Assignee
GE Medical Systems Information Technologies Incorporated
|
Original Assignee
GE Medical Systems Information Technologies Incorporated
|
Self-sealing materials and devices comprising same | ||
Patent #
US 20040052689A1
Filed 06/26/2003
|
Current Assignee
Porex Corporation
|
Original Assignee
POREX TECHNOLOGIES CORPORATION
|
Method of making a kink-resistant catheter | ||
Patent #
US 6,702,972 B1
Filed 08/23/2000
|
Current Assignee
Medtronic Minimed Incorporated
|
Original Assignee
DIAMETRICS MEDICAL LIMITED
|
Membrane for use with implantable devices | ||
Patent #
US 6,702,857 B2
Filed 07/27/2001
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Membrane for use with implantable devices | ||
Patent #
US 20030023317A1
Filed 07/27/2001
|
Current Assignee
DexCom Incorporated
|
Original Assignee
DexCom Incorporated
|
Porous three dimensional structure | ||
Patent #
US 6,520,997 B1
Filed 12/07/2000
|
Current Assignee
Baxter International Inc.
|
Original Assignee
Baxter International Inc.
|
Glucose sensor package system | ||
Patent #
US 6,520,326 B2
Filed 10/09/2001
|
Current Assignee
Medtronic Minimed Incorporated
|
Original Assignee
Medtronic Minimed Incorporated
|
Subcutaneous glucose electrode | ||
Patent #
US 6,514,718 B2
Filed 11/29/2001
|
Current Assignee
Therasense Incorporated
|
Original Assignee
Therasense Incorporated
|
Use of glucomannan hydrocolloid as filler material in prostheses | ||
Patent #
US 6,537,318 B1
Filed 04/06/1998
|
Current Assignee
KONJAC TECHNOLOGIES L.L.C.
|
Original Assignee
KONJAC TECHNOLOGIES LLC
|
Method of fabricating an interconnection element | ||
Patent #
US 6,336,269 B1
Filed 05/26/1995
|
Current Assignee
FormFactor Incorporated
|
Original Assignee
FormFactor Incorporated
|
Subcutaneous glucose measurement device | ||
Patent #
US 20020016535A1
Filed 01/26/2001
|
Current Assignee
Martin W. Blake, Micah D. Schmidt
|
Original Assignee
Martin W. Blake, Micah D. Schmidt
|
Glucose sensor package system | ||
Patent #
US 20020023852A1
Filed 10/09/2001
|
Current Assignee
Minimed Inc.
|
Original Assignee
Minimed Inc.
|
Tissue engineering composite | ||
Patent #
US 20020022883A1
Filed 06/12/2001
|
Current Assignee
Clemson University
|
Original Assignee
Clemson University
|
Glucose sensor package system | ||
Patent #
US 6,360,888 B1
Filed 02/10/2000
|
Current Assignee
Medtronic Minimed Incorporated
|
Original Assignee
Minimed Inc.
|
Sensor array for rapid materials characterization | ||
Patent #
US 20020032531A1
Filed 05/23/2001
|
Current Assignee
Freeslate Inc.
|
Original Assignee
Symyx Technologies Incorporated
|
Silicone gel composition and silicone gel produced therefrom | ||
Patent #
US 6,169,155 B1
Filed 01/14/1999
|
Current Assignee
Dow Inc.
|
Original Assignee
Dow Inc.
|
Analyte monitoring device and methods of use | ||
Patent #
US 6,175,752 B1
Filed 04/30/1998
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Therasense Incorporated
|
Phonopneumograph system | ||
Patent #
US 6,168,568 B1
Filed 10/04/1996
|
Current Assignee
Isonea Limited
|
Original Assignee
Karmel Medical Acoustic Technologies Ltd.
|
Modified polyurethane membrane sensors and analytical methods | ||
Patent #
US 6,200,772 B1
Filed 05/10/2000
|
Current Assignee
Sensalyse Holdings Limited
|
Original Assignee
Sensalyse Holdings Limited
|
Molecular imaging | ||
Patent #
US 6,017,435 A
Filed 04/23/1998
|
Current Assignee
deltaDOT Limited
|
Original Assignee
Imperial College of Science Technology Medicine
|
Slotted insulator for unsealed electrode edges in electrochemical cells | ||
Patent #
US 6,013,113 A
Filed 03/06/1998
|
Current Assignee
Greatbatch Limited
|
Original Assignee
Wilson Greatbatch Technologies Inc.
|
Cassette of lancet cartridges for sampling blood | ||
Patent #
US 6,036,924 A
Filed 12/04/1997
|
Current Assignee
Sanofi-Aventis Deutschland GmbH
|
Original Assignee
HP Inc.
|
Attachment apparatus for an implantable medical device employing ultrasonic energy | ||
Patent #
US 5,871,514 A
Filed 08/01/1997
|
Current Assignee
Medtronic Incorporated
|
Original Assignee
Medtronic Incorporated
|
Child birth assisting system | ||
Patent #
US 5,871,499 A
Filed 04/25/1997
|
Current Assignee
Paldo Co. Ltd.
|
Original Assignee
Novatrix Inc.
|
Polyurethane/polyurea compositions containing silicone for biosensor membranes | ||
Patent #
US 5,882,494 A
Filed 08/28/1995
|
Current Assignee
Minimed Inc.
|
Original Assignee
Minimed Inc.
|
Device for monitoring changes in analyte concentration | ||
Patent #
US 5,711,861 A
Filed 11/22/1995
|
Current Assignee
LEGACY GOOD SAMARITAN HOSPITAL AND MEDICAL CENTER
|
Original Assignee
Ward W. Kenneth, Eric S. Wilgus
|
Disposable transducer with digital processing and readout | ||
Patent #
US 5,711,302 A
Filed 03/03/1994
|
Current Assignee
Merit Medical Systems Inc.
|
Original Assignee
Merit Medical Systems Inc.
|
Sensor device covered with foam membrane | ||
Patent #
US 5,706,807 A
Filed 10/11/1996
|
Current Assignee
Applied Medical Research
|
Original Assignee
Applied Medical Research
|
Tissue implant systems | ||
Patent #
US 5,713,888 A
Filed 06/05/1995
|
Current Assignee
Baxalta Incorporated, Baxalta GmbH
|
Original Assignee
Baxter International Inc.
|
Protective shield for a blood glucose strip | ||
Patent #
US 5,714,123 A
Filed 09/30/1996
|
Current Assignee
Lifescan Incorporated
|
Original Assignee
Lifescan Incorporated
|
Ported tissue implant systems and methods of using same | ||
Patent #
US 5,733,336 A
Filed 03/30/1995
|
Current Assignee
Baxter International Inc.
|
Original Assignee
Baxter International Inc.
|
Subcutaneous glucose electrode | ||
Patent #
US 5,593,852 A
Filed 09/01/1994
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Adam Heller, Michael V. Pishko
|
Tissue implant systems and methods for sustaining viable high cell densities within a host | ||
Patent #
US 5,593,440 A
Filed 05/23/1994
|
Current Assignee
Baxter International Inc.
|
Original Assignee
Baxter International Inc.
|
Breathable liquid elimination analysis | ||
Patent #
US 5,590,651 A
Filed 01/17/1995
|
Current Assignee
Temple University of The Commonwealth System of Higher Education
|
Original Assignee
Temple University of The Commonwealth System of Higher Education
|
Flex circuit connector | ||
Patent #
US 5,482,473 A
Filed 05/09/1994
|
Current Assignee
MINI Med Incorporated
|
Original Assignee
Minimed Inc.
|
Measuring device with connection for a removable sensor | ||
Patent #
US 5,502,396 A
Filed 09/21/1994
|
Current Assignee
Asulab SA
|
Original Assignee
Asulab SA
|
Biocompatible microcapsules | ||
Patent #
US 5,380,536 A
Filed 08/05/1991
|
Current Assignee
Board of Regents of the University of Texas System
|
Original Assignee
Board of Regents of the University of Texas System
|
Biosensor with a data memory | ||
Patent #
US 5,384,028 A
Filed 08/27/1993
|
Current Assignee
NEC Corporation
|
Original Assignee
NEC Corporation
|
Transcutaneous sensor insertion set | ||
Patent #
US 5,390,671 A
Filed 03/15/1994
|
Current Assignee
Medtronic Minimed Incorporated
|
Original Assignee
Minimed Inc.
|
Method of fabricating thin film sensors | ||
Patent #
US 5,391,250 A
Filed 03/15/1994
|
Current Assignee
Medtronic Minimed Incorporated
|
Original Assignee
Minimed Inc.
|
Enhancing the hydrophilicity of silicone polymers | ||
Patent #
US 5,397,848 A
Filed 05/21/1993
|
Current Assignee
Abbott Medical Optics Incorporated
|
Original Assignee
Allergan Inc. Canada
|
Fluid sample analyte collector and calibration assembly | ||
Patent #
US 5,284,570 A
Filed 06/26/1991
|
Current Assignee
RADIOMETER CALIFORNIA INC.
|
Original Assignee
PPG Industries Incorporated
|
Self-supporting woven vascular graft | ||
Patent #
US 5,282,848 A
Filed 04/19/1993
|
Current Assignee
Maquet Cardiovascular LLC
|
Original Assignee
Meadox Medicals Inc.
|
Continuous display of peak and mean blood flow velocities | ||
Patent #
US 5,287,753 A
Filed 05/02/1992
|
Current Assignee
Advanced Technology Materials Inc.
|
Original Assignee
Advanced Technology Materials Inc.
|
Enzyme electrochemical sensor electrode and method of making it | ||
Patent #
US 5,082,550 A
Filed 12/11/1989
|
Current Assignee
The United States of America As Represented By The Secretary of Agriculture
|
Original Assignee
United States Of America As Represented By The Department Of Energy
|
Vivo refillable glucose sensor | ||
Patent #
US 4,986,271 A
Filed 07/19/1989
|
Current Assignee
The University of New Mexico
|
Original Assignee
The University of New Mexico
|
Fitting for fastening the rail member of a drawer | ||
Patent #
US 4,984,929 A
Filed 05/16/1989
|
Current Assignee
Julius BLUM GmbH
|
Original Assignee
Julius BLUM GmbH
|
Sterilizing dressing device and method for skin puncture | ||
Patent #
US 4,988,341 A
Filed 06/05/1989
|
Current Assignee
Clinical Diagnostic Systems Inc.
|
Original Assignee
Eastman Kodak Company
|
Fluorosilicone rubber composition | ||
Patent #
US 4,988,758 A
Filed 07/21/1988
|
Current Assignee
Shin-Etsu Chemical Company Limited
|
Original Assignee
Shin-Etsu Chemical Company Limited
|
Biological fluid measuring device | ||
Patent #
US 4,994,167 A
Filed 07/07/1988
|
Current Assignee
DexCom Incorporated
|
Original Assignee
Markwell Medical Institute Inc.
|
Two-dimensional diffusion glucose substrate sensing electrode | ||
Patent #
US 4,890,620 A
Filed 02/17/1988
|
Current Assignee
Regents of the University of California
|
Original Assignee
Regents of the University of California
|
Device for protecting a wound | ||
Patent #
US 4,795,435 A
Filed 02/08/1984
|
Current Assignee
E R Squibb Sons Incorporated
|
Original Assignee
E R Squibb Sons Incorporated
|
Block-graft copolymer | ||
Patent #
US 4,803,243 A
Filed 03/25/1987
|
Current Assignee
Shin-Etsu Chemical Company Limited
|
Original Assignee
Shin-Etsu Chemical Company Limited
|
Volume independent diagnostic device | ||
Patent #
US 4,810,470 A
Filed 06/19/1987
|
Current Assignee
Miles Inc.
|
Original Assignee
Miles Inc.
|
Implantable gas-containing biosensor and method for measuring an analyte such as glucose | ||
Patent #
US 4,721,677 A
Filed 05/07/1987
|
Current Assignee
Childrens Hospital Medical Center
|
Original Assignee
Childrens Hospital Medical Center
|
Method of producing combination ion selective sensing electrode | ||
Patent #
US 4,565,666 A
Filed 07/18/1984
|
Current Assignee
Medtronic Incorporated
|
Original Assignee
Medtronic Incorporated
|
Drug dispensing body implantable lead employing molecular sieves and methods of fabrication | ||
Patent #
US 4,577,642 A
Filed 02/27/1985
|
Current Assignee
Medtronic Incorporated
|
Original Assignee
Medtronic Incorporated
|
Plural module medication delivery system | ||
Patent #
US 4,494,950 A
Filed 01/19/1982
|
Current Assignee
Johns Hopkins University
|
Original Assignee
Johns Hopkins University
|
Drug dispensing body implantable lead | ||
Patent #
US 4,506,680 A
Filed 03/17/1983
|
Current Assignee
Medtronic Incorporated
|
Original Assignee
Medtronic Incorporated
|
Enzyme electrode | ||
Patent #
US 4,431,507 A
Filed 01/12/1982
|
Current Assignee
Matsushita Electric Industrial Company Limited
|
Original Assignee
Matsushita Electric Industrial Company Limited
|
Implantable glucose sensor | ||
Patent #
US 4,431,004 A
Filed 10/27/1981
|
Current Assignee
Ennis C. Layne, Samuel P. Bessman, Lyell J. Thomas
|
Original Assignee
Ennis C. Layne, Samuel P. Bessman, Lyell J. Thomas
|
Oxygen stabilized enzyme electrode | ||
Patent #
US 4,374,013 A
Filed 03/03/1981
|
Current Assignee
Sven-Olof Enfors
|
Original Assignee
Sven-Olof Enfors
|
Micro pH electrode assembly for wire transmission | ||
Patent #
US 4,319,578 A
Filed 10/09/1979
|
Current Assignee
General Mills Incorporated
|
Original Assignee
General Mills Incorporated
|
Filled cables | ||
Patent #
US 4,259,540 A
Filed 04/20/1979
|
Current Assignee
Bell Telephone Laboratories Inc.
|
Original Assignee
Bell Telephone Laboratories Inc.
|
Vibration resistant electrochemical cell having deformed casing and method of making same | ||
Patent #
US 4,255,500 A
Filed 03/29/1979
|
Current Assignee
Gates Energy Products Inc.
|
Original Assignee
General Electric Company
|
Catheter placement assembly improvement | ||
Patent #
US 4,068,660 A
Filed 07/12/1976
|
Current Assignee
Deseret Medical Inc.
|
Original Assignee
DESERET PHARMACEUTICAL CO. INC.
|
Membrane for enzyme electrodes | ||
Patent #
US 4,073,713 A
Filed 07/26/1976
|
Current Assignee
The Yellow Springs Instrument Company Inc.
|
Original Assignee
THE YELLOW SPRINGS INSTRUMENT COMPANY INC.
|
Method of producing porous plastic materials | ||
Patent #
US 4,076,656 A
Filed 07/20/1973
|
Current Assignee
DeBell Richardson Inc.
|
Original Assignee
DEBELL RICHARDSON INC.
|
Electrical connector employing conductive rectilinear elements | ||
Patent #
US 4,003,621 A
Filed 06/16/1975
|
Current Assignee
Fuji Polymer Industries Co. Ltd.
|
Original Assignee
TECHNICAL WIRE PRODUCTS INC.
|
Analyte monitoring device and methods of use | ||
Patent #
US 8,366,614 B2
Filed 03/30/2009
|
Current Assignee
Abbott Diabetes Care Incorporated
|
Original Assignee
Abbott Diabetes Care Incorporated
|
Electrode for electroanalytic studies | ||
Patent #
US 3,882,011 A
Filed 12/26/1973
|
Current Assignee
Theodore G. Hines, Dennis C. Johnson
|
Original Assignee
Pine Instrument Company
|
35 Claims
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1. A device for measuring an analyte in a host, the device comprising:
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a sensor operably connected to sensor electronics, the sensor electronics configured for measuring an analyte in a host;
at least one electrical contact configured to connect the sensor to the sensor electronics; and
a sealing member, wherein the sealing member at least partially surrounds at least one of the sensor and the electrical contact, wherein the sealing member comprises a material having a durometer hardness of from about 5 Shore A to about 80 Shore A. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A device for use in measuring an analyte in a host, the device comprising:
-
a sensor operably connected to sensor electronics, the sensor electronics configured for measuring an analyte in a host;
at least one electrical contact configured to operably connect the sensor to the sensor electronics; and
a sealing member at least partially surrounding at least one of the sensor and the electrical contact, wherein the sealing member is configured to seal the electrical contact from moisture when the sensor is operably connected to the sensor electronics. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28)
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29. A device for use in measuring an analyte in a host, the device comprising:
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a sensor operably connected to sensor electronics, the sensor electronics configured for measuring an analyte in a host;
at least one electrical contact configured to connect the sensor to the sensor electronics, wherein the electrical contact comprises a material having a durometer hardness of from about 5 Shore A to about 80 Shore A; and
a sealing member at least partially surrounding at least one of the sensor and the electrical contact, wherein the sealing member comprises a material having a durometer hardness of from about 5 Shore A to about 80 Shore A. - View Dependent Claims (30, 31, 32, 33, 34, 35)
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1 Specification
This application is a continuation-in-part of U.S. Application No. 11/077,715 filed Mar. 10, 2005, which claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 60/587,787 filed Jul. 13, 2004; U.S. Provisional Application No. 60/587,800 filed Jul. 13, 2004; U.S. Provisional Application No. 60/614,683 filed Sep. 30, 2004; and U.S. Provisional Application No. 60/614,764 filed Sep. 30, 2004, each of which is incorporated by reference herein in its entirety, and each of which is hereby made a part of this specification.
The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.
Diabetes mellitus is a disorder in which the pancreas cannot create sufficient insulin (Type I or insulin dependent) and/or in which insulin is not effective (Type 2 or non-insulin dependent). In the diabetic state, the victim suffers from high blood sugar, which can cause an array of physiological derangements associated with the deterioration of small blood vessels, for example, kidney failure, skin ulcers, or bleeding into the vitreous of the eye. A hypoglycemic reaction (low blood sugar) can be induced by an inadvertent overdose of insulin, or after a normal dose of insulin or glucose-lowering agent accompanied by extraordinary exercise or insufficient food intake.
Conventionally, a person with diabetes carries a self-monitoring blood glucose (SMBG) monitor, which typically requires uncomfortable finger pricking methods. Due to the lack of comfort and convenience, a person with diabetes normally only measures his or her glucose levels two to four times per day. Unfortunately, such time intervals are so far spread apart that the person with diabetes likely finds out too late of a hyperglycemic or hypoglycemic condition, sometimes incurring dangerous side effects. It is not only unlikely that a person with diabetes will take a timely SMBG value, it is also likely that he or she will not know if his or her blood glucose value is going up (higher) or down (lower) based on conventional method. This inhibits the ability to make educated insulin therapy decisions.
A variety of sensors are known that use an electrochemical cell to provide output signals by which the presence or absence of an analyte, such as glucose, in a sample can be determined. For example, in an electrochemical cell, an analyte (or a species derived from it) that is electro-active generates a detectable signal at an electrode, and this signal can be used to detect or measure the presence and/or amount within a biological sample. In some conventional sensors, an enzyme is provided that reacts with the analyte to be measured, and the byproduct of the reaction is qualified or quantified at the electrode. An enzyme has the advantage that it can be very specific to an analyte and also, when the analyte itself is not sufficiently electro-active, can be used to interact with the analyte to generate another species which is electro-active and to which the sensor can produce a desired output. In one conventional amperometric glucose oxidase-based glucose sensor, immobilized glucose oxidase catalyses the oxidation of glucose to form hydrogen peroxide, which is then quantified by amperometric measurement (for example, change in electrical current) through a polarized electrode.
In a first aspect, a sensor for transcutaneous measurement of an analyte in a host is provided, the sensor comprising at least one electrode formed from a conductive material; and a membrane disposed on an electroactive portion of the electrode, wherein the membrane is configured to control an influx of the analyte therethrough, and wherein the membrane comprises a substantially non-smooth outer surface.
In an embodiment of the first aspect, the substantially non-smooth surface appears under magnification to resemble a super-positioning of disc shaped objects.
In an embodiment of the first aspect, the disc shaped objects comprise a rounded shape.
In an embodiment of the first aspect, the disc shaped objects have an average diameter of from about 5 microns to about 250 microns.
In an embodiment of the first aspect, the membrane further comprises an enzyme domain.
In an embodiment of the first aspect, the membrane further comprises an interference domain.
In an embodiment of the first aspect, the membrane further comprises an electrode domain.
In an embodiment of the first aspect, the membrane is at least partially formed by a vapor deposition coating process.
In an embodiment of the first aspect, the vapor deposition coating process comprises a physical vapor deposition coating process, e.g., ultrasonic vapor deposition.
In an embodiment of the first aspect, the membrane substantially resists ascorbate flux therethrough.
In an embodiment of the first aspect, the electrode comprises a wire comprising a conductive material, and wherein the sensor is configured for substantially continuous measurement of glucose in a host.
In a second aspect, a method for manufacturing a transcutaneous analyte sensor is provided, the method comprising the steps of providing at least one electrode comprising an electroactive portion; and applying a membrane to the electroactive port ion, wherein at least one layer of the membrane is applied by vapor deposition.
In an embodiment of the second aspect, the vapor deposition comprises physical vapor deposition.
In an embodiment of the second aspect, the physical vapor deposition comprises ultrasonic vapor deposition.
In an embodiment of the second aspect, the layer of the membrane is deposited in a vacuum chamber. The layer can be configured to resist flow of the analyte therethrough.
In an embodiment of the second aspect, at least one layer of the membrane is applied using an ultrasonic nozzle. The layer can be configured to resist flow of the analyte therethrough.
In an embodiment of the second aspect, the step of applying a membrane comprises applying an enzyme domain. The enzyme domain can be applied by dip coating.
In an embodiment of the second aspect, the step of applying a membrane comprises applying an electrode domain. The electrode domain can be applied by dip coating.
In an embodiment of the second aspect, the electrode comprises a wire comprising a conductive material, and wherein the sensor is configured for substantially continuous measurement of glucose in a host.
In a third aspect, a method for manufacturing a plurality of transcutaneous analyte sensors is provided, the method comprising providing a plurality of electrodes, each electrode comprising an electroactive portion; placing the plurality of electrodes into a vacuum chamber; and vapor depositing at least one membrane layer thereon.
In an embodiment of the third aspect, the membrane layer is configured to control influx of an analyte therethrough.
In an embodiment of the third aspect, wherein an in vitro sensitivity of the plurality of sensors deviates from a median in vitro sensitivity by less about 20%.
In an embodiment of the third aspect, an in vitro sensitivity of the plurality of sensors deviates from a median in vitro sensitivity by less about 16%.
In an embodiment of the third aspect, an in vitro sensitivity of the plurality of sensors deviates from a median in vitro sensitivity by less about 12%.
In an embodiment of the third aspect, the method further comprises curing the membrane layer. The curing step can include placing a plurality of electrodes, each comprising the membrane layer, into a vacuum oven, a convection oven, or a variable frequency microwave oven.
In an embodiment of the third aspect, each electrode comprises a wire comprising a conductive material, and wherein each sensor is configured for substantially continuous measurement of glucose in a host.
In a fourth aspect, a method for limiting use of an analyte sensor to a predetermined time period is provided, the method comprising providing a key associated with an analyte sensor, wherein the key is configured to control an amount of time over which information is obtained from the analyte sensor.
In an embodiment of the fourth aspect, the analyte sensor is a transcutaneous glucose sensor.
In an embodiment of the fourth aspect, the sensor is operatively connected to a receiver, wherein the receiver is configured to display sensor data.
In an embodiment of the fourth aspect, the receiver is configured to receive the key.
In an embodiment of the fourth aspect, the receiver is configured to control an amount of time over which information is displayed on the receiver from the sensor in response to the key.
In an embodiment of the fourth aspect, the key is a software key.
In an embodiment of the fourth aspect, the key is a unique code.
In an embodiment of the fourth aspect, the key is selected from the group consisting of a unique number, a receiver ID, a sensor duration, a number of sensor systems, and combinations thereof.
In an embodiment of the fourth aspect, the key is configured for use with a plurality of sensors.
In an embodiment of the fourth aspect, the key is provided by an information tag.
In a fifth aspect, a method for distributing and controlling use of implantable sensor systems comprising reusable and disposable parts, the method comprising providing a single-use device associated with the sensor system, wherein the single-use device is configured to be inserted into a host'"'"'s tissue; providing a key associated with the single-use device; and providing a reusable device associated with a sensor system, wherein the reusable device is configured to provide sensor information responsive to receipt of the key.
In an embodiment of the fifth aspect, the reusable device comprises a receiver configured to receive sensor information.
In an embodiment of the fifth aspect, the reusable device further comprises an electronics unit configured to releasably mate with the single-use device.
In an embodiment of the fifth aspect, the method further comprises obtaining a package containing a plurality of single-use devices.
In an embodiment of the fifth aspect, the single-use device is a transcutaneous analyte sensor configured for insertion into a subcutaneous tissue of a host.
In an embodiment of the fifth aspect, the key comprises a written license code packaged with the single-use device.
In an embodiment of the fifth aspect, the step of providing the key comprises providing a license code via at least one communication selected from the group consisting of written communication, voice communication, and electronic communication.
In an embodiment of the fifth aspect, the reusable device is configured to receive the key via manual entry.
In an embodiment of the fifth aspect, the reusable device is configured to wirelessly receive the key.
In an embodiment of the fifth aspect, key comprises sensor duration information configured to enable the sensor system to control an amount of time over which information is obtained from the single-use device or is displayed by the reusable device.
In an embodiment of the fifth aspect, the single-use device comprises a transcutaneous analyte sensor configured for insertion in a subcutaneous tissue of a host, and wherein the key comprises sensor insertion information configured to enable the sensor system to control a number of sensor insertions.
In an embodiment of the fifth aspect, the single-use device comprises a transcutaneous analyte sensor configured for insertion in a subcutaneous tissue of a host, and wherein the step of inserting the single-use device into a host comprises using an applicator to insert the sensor into the host.
In an embodiment of the fifth aspect, the step of obtaining sensor information from the sensor system comprises at least one step selected from the group consisting of measurement of analyte information, digitalizing of sensor information, transmission of sensor information, receiving of sensor information, storing of sensor information, processing of sensor information, and displaying of sensor information.
In a sixth aspect, a method for limiting use of a glucose sensor system to a predetermined time period is provided, the method comprising inputting a key into a receiver, wherein the key is configured to control an amount of time over which information is obtained from a sensor system, after which time the sensor system is disabled such that glucose information cannot be obtained, wherein the sensor system is a transcutaneous glucose sensor system comprising a sensor configured for insertion into a tissue of a host and an electronics unit operatively connected to the sensor and configured to provide a signal representative of a glucose concentration in the host, and wherein the receiver is configured to receive the signal representative of a glucose concentration in the host and to display corresponding glucose information; and obtaining glucose information from the sensor.
In an embodiment of the sixth aspect, the step of inputting the key into the receiver is performed before the step of obtaining glucose information from the sensor.
In a seventh aspect, a device for measuring an analyte in a host is provided, the device comprising a sensor operably connected to sensor electronics, the sensor electronics configured for measuring an analyte in a host; at least one electrical contact configured to connect the sensor to the sensor electronics; and a sealing member, wherein the sealing member at least partially surrounds at least one of the sensor and the electrical contact, wherein the sealing member comprises a material having a durometer hardness of from about 5 Shore A to about 80 Shore A.
In an embodiment of the seventh aspect, the durometer hardness is from about 10 Shore A to about 50 Shore A.
In an embodiment of the seventh aspect, the durometer hardness is about 20 Shore A.
In an embodiment of the seventh aspect, the durometer hardness is about 50 Shore A
In an embodiment of the seventh aspect, the sensor comprises a wire.
In an embodiment of the seventh aspect, the sensor comprises a planar substrate.
In an embodiment of the seventh aspect, the sealing material comprises a silicone.
In an embodiment of the seventh aspect, the device further comprises a sealant adjacent to the sealing member.
In an embodiment of the seventh aspect, the sensor electronics are housed within an electronics unit configured to mate with the electrical contact.
In an embodiment of the seventh aspect, the electronics unit and the sealing member are configured to mate to provide a compression force therebetween.
In an embodiment of the seventh aspect, the device further comprises at least one raised portion configured to provide a compression force to the sealing member when the electrical contact is connected to the sensor electronics.
In an eighth embodiment, a device for use in measuring an analyte in a host is provided, the device comprising a sensor operably connected to sensor electronics, the sensor electronics configured for measuring an analyte in a host; at least one electrical contact configured to operably connect the sensor to the sensor electronics; and a sealing member at least partially surrounding at least one of the sensor and the electrical contact, wherein the sealing member is configured to seal the electrical contact from moisture when the sensor is operably connected to the sensor electronics.
In an embodiment of the eighth aspect, the sealing member comprises a material having a durometer hardness of from about 5 Shore A to about 80 Shore A.
In an embodiment of the eighth aspect, the device further comprises a sealant adjacent to the sealing member.
In an embodiment of the eighth aspect, the device further comprises a housing on which the sealing member is disposed, wherein the housing is configured to mechanically or chemically hold the sealing member thereon.
In an embodiment of the eighth aspect, the device further comprises an adhesive configured to hold the sealing member on the housing.
In an embodiment of the eighth aspect, the device further comprises at least one protrusion configured to substantially mate with at least one depression, whereby the sealing member is held on the housing.
In an embodiment of the eighth aspect, the sealing member comprises at least one gap that is maintained when the electrical contact is operably connected to the sensor electronics.
In an embodiment of the eighth aspect, the sensor at least partially extends through the gap.
In an embodiment of the eighth aspect, the gap is filled with a sealant.
In an embodiment of the eighth aspect, the device further comprises at least one channel communicating between a first side of the sealing member and a second side of the sealing member.
In an embodiment of the eighth aspect, the channel is filled with a sealant.
In an embodiment of the eighth aspect, substantially no air gaps are adjacent to the electrical contact when the electrical contact is operably connected to the sensor electronics.
In an embodiment of the eighth aspect, the sealing member comprises a material selected from the group consisting of silicone, silicone/polyurethane hybrid, polyurethane, polysulfide, and mixtures thereof.
In an embodiment of the eighth aspect, the sealing member is self-lubricating.
In an embodiment of the eighth aspect, the sealing member comprises a sealant sandwiched between an upper portion of the sealing member and a lower portion of the sealing member.
In an embodiment of the eighth aspect, the device further comprises a guide tube configured to maintain an opening in the sealing member prior to sensor insertion into the host.
In an embodiment of the eighth aspect, the device further comprises a lubricant between the sealing member and the guide tube.
In a ninth aspect, a device for use in measuring an analyte in a host is provided, the device comprising a sensor operably connected to sensor electronics, the sensor electronics configured for measuring an analyte in a host; at least one electrical contact configured to connect the sensor to the sensor electronics, wherein the electrical contact comprises a material having a durometer hardness of from about 5 Shore A to about 80 Shore A; and a sealing member at least partially surrounding at least one of the sensor and the electrical contact, wherein the sealing member comprises a material having a durometer hardness of from about 5 Shore A to about 80 Shore A.
In an embodiment of the ninth aspect, the durometer hardness of the electrical contact is higher than the durometer hardness of the sealing member.
In an embodiment of the ninth aspect, the durometer hardness of the electrical contact is about 50 Shore A.
In an embodiment of the ninth aspect, the durometer hardness of the sealing member is higher than the durometer hardness of the contact.
In an embodiment of the ninth aspect, the durometer hardness of the sealing member is about 50 Shore A.
In an embodiment of the ninth aspect, the sealing member comprises a filler material.
In an embodiment of the ninth aspect, the filler material is configured to stiffen the sealing member.
In a tenth aspect, a sensor system for measuring an analyte concentration in a host is provided, the system comprising at least one electrode configured for implantation in a host and configured to measure an analyte concentration in a tissue of the host; sensor electronics operably connected to the electrode and configured to provide analyte data representative of an analyte concentration in the host; and an information tag comprising sensor information.
In an embodiment of the tenth aspect, the information tag comprises a memory.
In an embodiment of the tenth aspect, the information tag transmits information using at least one connection selected from the group consisting of a serial connection, a radio frequency connection, an acoustic frequency connection, an infrared frequency connection, and a magnetic induction connection.
In an embodiment of the tenth aspect, the system further comprises a mounting unit configured to maintain the sensor positioned transcutaneously within the tissue of the host.
In an embodiment of the tenth aspect, the information tag is embedded within the mounting unit.
In an embodiment of the tenth aspect, the system further comprises a receiver configured to receive the analyte data from the sensor electronics.
In an embodiment of the tenth aspect, the receiver is configured to read sensor information from the information tag.
In an embodiment of the tenth aspect, the system further comprises packaging configured to contain at least a portion of a sensor system during transport.
In an embodiment of the tenth aspect, the information tag is in or on the packaging.
In an embodiment of the tenth aspect, the sensor information comprises at least one item selected from the group consisting of manufacturing information, calibration information, identification information, expiration information, sensor duration information, and archived data.
In an embodiment of the tenth aspect, the sensor information comprises a license code.
In an eleventh aspect, a transcutaneous analyte sensor assembly is provided, the assembly comprising a mounting unit adapted for mounting on a skin of a host; an electronics unit configured to releasably mate with the mounting unit; a sensor configured to measure a concentration of an analyte in the host, wherein the sensor is operably connected to the electronics unit when the electronics unit is mated to the mounting unit; and an information tag comprising sensor information.
In an embodiment of the eleventh aspect, the sensor information is embedded in an information tag within the mounting unit.
In an embodiment of the eleventh aspect, the assembly further comprises a receiver, wherein the receiver is configured to read sensor information from the information tag.
In an embodiment of the eleventh aspect, the information tag comprises a memory.
In an embodiment of the eleventh aspect, the information tag transmits information using at least one connection selected from the group consisting of a serial connection, a radio frequency connection, an acoustic frequency connection, an infrared frequency connection, and a magnetic induction connection.
In an embodiment of the eleventh aspect, the sensor information is embedded within the electronics unit.
In an embodiment of the eleventh aspect, the assembly further comprises packaging configured to contain the sensor assembly during transport, wherein the information tag is provided in or on the packaging.
In an embodiment of the eleventh aspect, the assembly further comprises a receiver, wherein the receiver is configured to read the sensor information from the information tag.
In an embodiment of the eleventh aspect, the sensor information comprises information configured to trigger initialization of the sensor.
In a twelfth aspect, a transcutaneous glucose sensor system is provided, the sensor system comprising a mounting unit adapted for mounting on a skin of a host; a sensor configured to measure an analyte concentration in the host; sensor electronics operably connected to the sensor, wherein the sensor is configured to provide data representative of an analyte concentration in the host; a receiver remote from the mounting unit and configured to receive sensor data from the electronics unit representative of a measured analyte concentration; and an information tag configured to provide sensor information selected from the group consisting of manufacturing information, calibration information, identification information, expiration information, sensor duration information, archived data, license code information, and combinations thereof.
In an embodiment of the twelfth aspect, the receiver is configured to read sensor information from the information tag.
In an embodiment of the twelfth aspect, the electronics unit is configured to releasably mate with the mounting unit, and wherein the electronics unit is operably connected to the sensor when the electronics unit is mated to the mounting unit.
In a thirteenth aspect, a device configured for placement on a skin surface of a host is provided, the device comprising a sensor configured for transcutaneous insertion into a host and operatively connected to sensor electronics for processing data obtained from the sensor; and a housing adapted for placement on a skin surface of the host and coupled to the sensor electronics, wherein at least one of the housing and the sensor electronics comprises a user interface configured to communicate information responsive to processed sensor data.
In an embodiment of the thirteenth aspect, the user interface comprises a screen configured to display at least one numerical value.
In an embodiment of the thirteenth aspect, the user interface comprises a screen configured to display trend information.
In an embodiment of the thirteenth aspect, the user interface comprises a screen configured to display graphical information.
In an embodiment of the thirteenth aspect, the user interface is configured to communicate information audibly.
In an embodiment of the thirteenth aspect, the user interface is configured to communicate information tactilely.
In an embodiment of the thirteenth aspect, the user interface is configured to provide information to the host in response to activation of a button.
In an embodiment of the thirteenth aspect, the sensor electronics are configured to alert the host when the sensor data is outside a predetermined boundary.
In an embodiment of the thirteenth aspect, the sensor electronics are configured to filter the sensor data.
In an embodiment of the thirteenth aspect, the sensor electronics are configured to calibrate the sensor data.
In an embodiment of the thirteenth aspect, the device further comprises a receiver, wherein the receiver is configured to communicate with the sensor electronics.
In an embodiment of the thirteenth aspect, the receiver is configured to request information from the sensor electronics.
In an embodiment of the thirteenth aspect, the sensor electronics are configured to transmit sensor data responsive to a request by the receiver.
In an embodiment of the thirteenth aspect, the receiver and the sensor electronics are operatively connected by at least one connection selected from the group consisting of a cable, a radio frequency connection, an optical connection, an inductive coupling connection, an infrared connection, and a microwave connection.
In an embodiment of the thirteenth aspect, the sensor electronics are releasably attachable to the housing.
In a fourteenth aspect, a transcutaneous glucose sensing device is provided, the device comprising a glucose sensor configured for transcutaneous insertion through a skin of a host; and an on-skin housing coupled to the sensor, wherein the on-skin housing is adhered to the skin, and wherein the on-skin housing comprises sensor electronics configured to process sensor data and to provide sensor data to the host via a user interface.
In an embodiment of the fourteenth aspect, the user interface is configured to provide sensor data by at least method selected from the group consisting of visually, audibly, and tactilely.
In an embodiment of the fourteenth aspect, the user interface is housed on or in toe on-skin housing.
In an embodiment of the fourteenth aspect, the user interface is operatively connected to the on-skin housing via at least one wire.
In an embodiment of the fourteenth aspect, the user interface is configured to be worn on the host at a location remote from the on-skin housing.
In an embodiment of the fourteenth aspect, the user interface is configured to be worn on clothing of the host, and wherein the on-skin housing in configured to be worn on the skin of the host.
In an embodiment of the fourteenth aspect, the user interface is directly wired to the on-skin housing.
In an embodiment of the fourteenth aspect, the sensor electronics are releasably attachable to the on-skin housing.
In a fifteenth aspect, a transcutaneous glucose sensor system is provided, the system comprising a glucose sensor configured for transcutaneous insertion through skin of a host; an on-skin device coupled to the sensor and comprising electronics configured to process data obtained from the sensor; and a receiver remote from the on-skin device configured to request information from the on-skin device.
In an embodiment of the fifteenth aspect, the on-skin device is configured to provide sensor information indicative of a glucose value of the host by at least one method selected from the group consisting of visual, audible, and tactile.
In an embodiment of the fifteenth aspect, the on-skin device is configured to provide filtered sensor data by at least one method selected from the group consisting of visual, audible, and tactile.
In an embodiment of the fifteenth aspect, the on-skin device is configured to provide calibrated sensor data by at least one method selected from the group consisting of visual, audible, and tactile.
The following description and examples illustrate some exemplary embodiments of the disclosed invention in detail. Those of skill in the art will recognize that there are numerous variations and modifications of this invention that are encompassed by its scope. Accordingly, the description of a certain exemplary embodiment should not be deemed to limit the scope of the present invention.
Definitions
In order to facilitate an understanding of the preferred embodiments, a number of terms are defined below.
The term “analyte” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a substance or chemical constituent in a biological fluid (for example, blood, interstitial fluid, cerebral spinal fluid, lymph fluid or urine) that can be analyzed. Analytes can include naturally occurring substances, artificial substances, metabolites, and/or reaction products. In some embodiments, the analyte for measurement by the sensing regions, devices, and methods is glucose. However, other analytes are contemplated as well, including but not limited to acarboxyprothrombin; acylcamitine; adenine phosphoribosyl transferase; adenosine deaminase; albumin; alpha-fetoprotein; amino acid profiles (arginine (Krebs cycle), histidine/urocanic acid, homocysteine, phenylalanine/tyrosine, tryptophan); andrenostenedione; antipyrine; arabinitol enantiomers; arginase; benzoylecgonine (cocaine); biotinidase; biopterin; c-reactive protein; carnitine; carnosinase; CD4; ceruloplasmin; chenodeoxycholic acid; chloroquine; cholesterol; cholinesterase; conjugated 1-13 hydroxy-cholic acid; cortisol; creatine kinase; creatine kinase MM isoenzyme; cyclosporin A; d-penicillamine; de-ethylchloroquine; dehydroepiandrosterone sulfate; DNA (acetylator polymorphism, alcohol dehydrogenase, alpha 1-antitrypsin, cystic fibrosis, Duchenne/Becker muscular dystrophy, glucose-6-phosphate dehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F, D-Punjab, beta-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1, Leber hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax, sexual differentiation, 21-deoxycortisol); desbutylhalofantrine; dihydropteridine reductase; diptheria/tetanus antitoxin; erythrocyte arginase; erythrocyte protoporphyrin; esterase D; fatty acids/acylglycines; free β-human chorionic gonadotropin; free erythrocyte porphyrin; free thyroxine (FT4); free tri-iodothyronine (FT3); fumarylacetoacetase; galactose/gal-1-phosphate; galactose-1-phosphate uridyltransferase; gentamicin; glucose-6-phosphate dehydrogenase; glutathione; glutathione perioxidase; glycocholic acid; glycosylated hemoglobin; halofantrine; hemoglobin variants; hexosaminidase A; human erythrocyte carbonic anhydrase I; 17-alpha-hydroxyprogesterone; hypoxanthine phosphoribosyl transferase; immunoreactive trypsin; lactate; lead; lipoproteins ((a), B/A-1, β); lysozyme; mefloquine; netilmicin; phenobarbitone; phenyloin; phytanic/pristanic acid; progesterone; prolactin; prolidase; purine nucleoside phosphorylase; quinine; reverse tri-iodothyronine (rT3); selenium; serum pancreatic lipase; sissomicin; somatomedin C; specific antibodies (adenovirus, anti-nuclear antibody, anti-zeta antibody, arbovirus, Aujeszky'"'"'s disease virus, dengue virus, Dracunculus medinensis, Echinococcus granulosus, Entamoeba histolytica, enterovirus, Giardia duodenalisa, Helicobacter pylori, hepatitis B virus, herpes virus, HIV-1, IgE (atopic disease), influenza virus, Leishmania donovani, leptospira, measles/mumps/rubella, Mycobacterium leprae, Mycoplasma pneumoniae, Myoglobin, Onchocerca volvulus, parainfluenza virus, Plasmodium falciparum, poliovirus, Pseudomonas aeruginosa, respiratory syncytial virus, rickettsia (scrub typhus), Schistosoma mansoni, Toxoplasma gondii, Trepenoma pallidium, Trypanosoma cruzi/rangeli, vesicular stomatis virus, Wuchereria bancrofti, yellow fever virus); specific antigens (hepatitis B virus, HIV-1); succinylacetone; sulfadoxine; theophylline; thyrotropin (TSH); thyroxine (T4); thyroxine-binding globulin; trace elements; transferrin; UDP-galactose-4-epimerase; urea; uroporphyrinogen I synthase; vitamin A; white blood cells; and zinc protoporphyrin. Salts, sugar, protein, fat, vitamins, and hormones naturally occurring in blood or interstitial fluids can also constitute analytes in certain embodiments. The analyte can be naturally present in the biological fluid, for example, a metabolic product, a hormone, an antigen, an antibody, and the like. Alternatively, the analyte can be introduced into the body, for example, a contrast agent for imaging, a radioisotope, a chemical agent, a fluorocarbon-based synthetic blood, or a drug or pharmaceutical composition, including but not limited to insulin; ethanol; cannabis (marijuana, tetrahydrocannabinol, hashish); inhalants (nitrous oxide, amyl nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons); cocaine (crack cocaine); stimulants (amphetamines, methamphetamines, Ritalin, Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine); depressants (barbituates, methaqualone, tranquilizers such as Valium, Librium, Miltown, Serax, Equanil, Tranxene); hallucinogens (phencyclidine, lysergic acid, mescaline, peyote, psilocybin); narcotics (heroin, codeine, morphine, opium, meperidine, Percocet, Percodan, Tussionex, Fentanyl, Darvon, Talwin, Lomotil); designer drugs (analogs of fentanyl, meperidine, amphetamines, methamphetamines, and phencyclidine, for example, Ecstasy); anabolic steroids; and nicotine. The metabolic products of drugs and pharmaceutical compositions are also contemplated analytes. Analytes such as neurochemicals and other chemicals generated within the body can also be analyzed, such as, for example, ascorbic acid, uric acid, dopamine, noradrenaline, 3-methoxytyramine (3MT), 3,4-dihydroxyphenylacetic acid (DOPAC), homovanillic acid (HVA), 5-hydroxytryptamine (5HT), histamine, Advanced Glycation End Products (AGEs) and 5-hydroxyindoleacetic acid (FHIAA).
The term “host” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to mammals, particularly humans.
The term “exit-site” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to the area where a medical device (for example, a sensor and/or needle) exits from the host'"'"'s body.
The term “continuous (or continual) analyte sensing” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to the period in which monitoring of analyte concentration is continuously, continually, and or intermittently (regularly or irregularly) performed, for example, about every 5 to 10 minutes.
The term “electrochemically reactive surface” as used herein is a broad term, and is not to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to the surface of an electrode where an electrochemical reaction takes place. For example, a working electrode measures hydrogen peroxide produced by the enzyme-catalyzed reaction of the analyte detected, which reacts to create an electric current. Glucose analyte can be detected utilizing glucose oxidase, which produces H2O2 as a byproduct. H2O2 reacts with the surface of the working electrode, producing two protons (2H+), two electrons (2e−) and one molecule of oxygen (O2), which produces the electronic current being detected.
The term “electronic connection” as used herein is a broad term, and is to to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to any electronic connection known to those in the art that can be utilized to interface the sensing region electrodes with the electronic circuitry of a device, such as mechanical (for example, pin and socket) or soldered electronic connections.
The term “sensing region” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to the region of a monitoring device responsible for the detection of a particular analyte. The sensing region generally comprises a non-conductive body, a working electrode (anode), a reference electrode (optional), and/or a counter electrode (cathode) passing through and secured within the body forming electrochemically reactive surfaces on the body and an electronic connective means at another location on the body, and a multi-domain membrane affixed to the body and covering the electrochemically reactive surface.
The term “high oxygen solubility domain” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a domain composed of a material that has higher oxygen solubility than aqueous media such that it concentrates oxygen from the biological fluid surrounding the membrane system. The domain can act as an oxygen reservoir during times of minimal oxygen need and has the capacity to provide, on demand, a higher oxygen gradient to facilitate oxygen transport across the membrane. Thus, the ability of the high oxygen solubility domain to supply a higher flux of oxygen to critical domains when needed can improve overall sensor function.
The term “domain” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a region of the membrane system that can be a layer, a uniform or non-uniform gradient (for example, an anisotropic region of a membrane), or a portion of a membrane.
The term “distal to” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to the spatial relationship between various elements in comparison to a particular point of reference. In general, the term indicates an element is located relatively far from the reference point than another element.
The term “proximal to” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to the spatial relationship between various elements in comparison to a particular point of reference. In general, the term indicates an element is located relatively near to the reference point than another element.
The term “in vivo portion” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to the portion of the device (for example, a sensor) adapted for insertion into and/or existence within a living body of a host.
The term “ex vivo portion” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to the portion of the device (for example, a sensor) adapted to remain and/or exist outside of a living body of a host.
The terms “raw data stream”, “raw data signal”, and “data stream” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to an analog or digital signal from the analyte sensor directly related to the measured analyte. For example, the raw data stream is digital data in “counts” converted by an A/D converter from an analog signal (for example, voltage or amps) representative of an analyte concentration. The terms broadly encompass a plurality of time spaced data points from a substantially continuous analyte sensor, each of which comprises individual measurements taken at time intervals ranging from fractions of a second up to, for example, 1, 2, or 5 minutes or longer.
The term “count” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a unit of measurement of a digital signal. For example, a raw data stream or raw data signal measured in counts is directly related to a voltage (for example, converted by an A/D converter), which is directly related to current from the working electrode.
The term “physiologically feasible” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to one or more physiological parameters obtained from continuous studies of glucose data in humans and/or animals. For example, a maximal sustained rate of change of glucose in humans of about 4 mg/dL/min to about 6 mg/dL/min and a maximum acceleration of the rate of change of about 0.1 mg/dL/min/min to about 0.2 mg/dL/min/min are deemed physiologically feasible limits. Values outside of these limits are considered non-physiological and are likely a result of, e.g., signal error.
The term “ischemia” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to local and temporary deficiency of blood supply due to obstruction of circulation to a part (for example, a sensor). Ischemia can be caused, for example, by mechanical obstruction (for example, arterial narrowing or disruption) of the blood supply.
The term “matched data pairs” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to reference data (for example, one or more reference analyte data points) matched with substantially time corresponding sensor data (for example, one or more sensor data points).
The term “Clarke Error Grid” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to an error grid analysis, for example, an error grid analysis used to evaluate the clinical significance of the difference between a reference glucose value and a sensor generated glucose value, taking into account 1) the value of the reference glucose measurement, 2) the value of the sensor glucose measurement, 3) the relative difference between the two values, and 4) the clinical significance of this difference. See Clarke et al., “Evaluating Clinical Accuracy of Systems for Self-Monitoring of Blood Glucose” Diabetes Care, Volume 10, Number 5, September-October 1987.
The term “Consensus Error Grid” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to an error grid analysis that assigns a specific level of clinical risk to any possible error between two time corresponding measurements, e.g., glucose measurements. The Consensus Error Grid is divided into zones signifying the degree of risk posed by the deviation. See Parkes et al., “A New Consensus Error Grid to Evaluate the Clinical Significance of Inaccuracies in the Measurement of Blood Glucose” Diabetes Care, Volume 23, Number 8, August 2000.
The term “clinical acceptability” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to determination of the risk of an inaccuracy to a patient. Clinical acceptability considers a deviation between time corresponding analyte measurements (for example, data from a glucose sensor and data from a reference glucose monitor) and the risk (for example, to the decision making of a person with diabetes) associated with that deviation based on the analyte value indicated by the sensor and/or reference data. An example of clinical acceptability can be 85% of a given set of measured analyte values within the “A” and “B” region of a standard Clarke Error Grid when the sensor measurements are compared to a standard reference measurement.
The terms “sensor” and “sensor system” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to the component or region of a device by which an analyte can be quantified.
The term “needle” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a slender hollow instrument for introducing material into or removing material from the body.
The terms “operatively connected,” “operatively linked,” “operably connected,” and “operably linked” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to one or more components linked to one or more other components. The terms can refer to a mechanical connection, an electrical connection, or a connection that allows transmission of signals between the components. For example, one or more electrodes can be used to detect the amount of analyte in a sample and to convert that information into a signal; the signal can then be transmitted to a circuit. In such an example, the electrode is “operably linked” to the electronic circuitry.
The term “baseline” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to the component of an analyte sensor signal that is not related to the analyte concentration. In one example of a glucose sensor, the baseline is composed substantially of signal contribution due to factors other than glucose (for example, interfering species, non-reaction-related hydrogen peroxide, or other electroactive species with an oxidation potential that overlaps with hydrogen peroxide). In some embodiments wherein a calibration is defined by solving for the equation y=m×+b, the value of b represents the baseline of the signal.
The terms “sensitivity” and “slope” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to an amount of electrical current produced by a predetermined amount (unit) of the measured analyte. For example, in one preferred embodiment, a sensor has a sensitivity (or slope) of about 3.5 to about 7.5 picoAmps of current for every 1 mg/dL of glucose analyte.
The term “membrane system” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a permeable or semi-permeable membrane that can be comprised of two or more domains and is typically constructed of materials of one or more microns in thickness, which is permeable to oxygen and is optionally permeable to, e.g., glucose or another analyte. In one example, the membrane system comprises an immobilized glucose oxidase enzyme, which enables a reaction to occur between glucose and oxygen whereby a concentration of glucose can be measured.
The terms “processor module” and “microprocessor” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to a computer system, state machine, processor, or the like designed to perform arithmetic or logic operations using logic circuitry that responds to and processes the basic instructions that drive a computer.
The terms “smoothing” and “filtering” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to modification of a set of data to make it smoother and more continuous or to remove or diminish outlying points, for example, by performing a moving average of the raw data stream.
The term “algorithm” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a computational process (for example, programs) involved in transforming information from one state to another, for example, by using computer processing.
The term “regression” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to finding a line for which a set of data has a minimal measurement (for example, deviation) from that line. Regression can be linear, non-linear, first order, second order, or the like. One example of regression is least squares regression.
The term “calibration” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to the process of determining the relationship between the sensor data and the corresponding reference data, which can be used to convert sensor data into meaningful values substantially equivalent to the reference data. In some embodiments, namely, in continuous analyte sensors, calibration can be updated or recalibrated over time as changes in the relationship between the sensor data and reference data occur, for example, due to changes in sensitivity, baseline, transport, metabolism, or the like.
The terms “interferents” and “interfering species” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to effects and/or species that interfere with the measurement of an analyte of interest in a sensor to produce a signal that does not accurately represent the analyte concentration. In one example of an electrochemical sensor, interfering species are compounds with an oxidation potential that overlap that of the analyte to be measured, thereby producing a false positive signal.
The terms “chloridization” and “chloridizing” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to treatment or preparation with chloride. The term “chloride” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, to refer to Cl− ions, sources of Cl− ions, and salts of hydrochloric acid. Chloridization and chloridizing methods include, but are not limited to, chemical and electrochemical methods.
The term “R-value” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to one conventional way of summarizing the correlation of data; that is, a statement of what residuals (e.g., root mean square deviations) are to be expected if the data are fitted to a straight line by the a regression.
The terms “data association” and “data association function” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to a statistical analysis of data and particularly its correlation to, or deviation from, from a particular curve. A data association function is used to show data association. For example, the data that forms that calibration set as described herein can be analyzed mathematically to determine its correlation to, or deviation from, a curve (e.g., line or set of lines) that defines the conversion function; this correlation or deviation is the data association. A data association function is used to determine data association. Examples of data association functions include, but are not limited to, linear regression, non-linear mapping/regression, rank (e.g., non-parametric) correlation, least mean square fit, mean absolute deviation (MAD), mean absolute relative difference. In one such example, the correlation coefficient of linear regression is indicative of the amount of data association of the calibration set that forms the conversion function, and thus the quality of the calibration.
The term “quality of calibration” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to the statistical association of matched data pairs in the calibration set used to create the conversion function. For example, an R-value can be calculated for a calibration set to determine its statistical data association, wherein an R-value greater than 0.79 determines a statistically acceptable calibration quality, while an R-value less than 0.79 determines statistically unacceptable calibration quality.
The term “congruence” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to the quality or state of agreeing, coinciding, or being concordant. In one example, congruence can be determined using rank correlation.
The term “concordant” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to being in agreement or harmony, and/or free from discord.
The phrase “continuous glucose sensing” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to the period in which monitoring of plasma glucose concentration is continuously or continually performed, for example, at time intervals ranging from fractions of a second up to, for example, 1, 2, or 5 minutes, or longer.
The term “single point glucose monitor” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a device that can be used to measure a glucose concentration within a host at a single point in time, for example, some embodiments utilize a small volume in vitro glucose monitor that includes an enzyme membrane such as described with reference to U.S. Pat. No. 4,994,167 and U.S. Pat. No. 4,757,022. It should be understood that single point glucose monitors can measure multiple samples (for example, blood or interstitial fluid); however only one sample is measured at a time and typically requires some user initiation and/or interaction.
The term “biological sample” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to sample of a host body, for example blood, interstitial fluid, spinal fluid, saliva, urine, tears, sweat, or the like.
The terms “substantial” and “substantially” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to a sufficient amount that provides a desired function. For example, the interference domain of the preferred embodiments is configured to resist a sufficient amount of interfering species such that tracking of glucose levels can be achieved, which may include an amount greater than 50 percent, an amount greater than 60 percent, an amount greater than 70 percent, an amount greater than 80 percent, and an amount greater than 90 percent of interfering species.
The terms “cellulosic derivatives” and “cellulosic polymers” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to derivatives of cellulose formed by reaction with carboxylic acid anhydrides. Examples of cellulosic derivatives include cellulose acetate, 2-hydroxyethyl cellulose, cellulose acetate phthalate, cellulose acetate propionate, cellulose acetate butyrate, cellulose acetate trimellitate, and the like.
The term “cellulose acetate” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to any of several compounds obtained by treating cellulose with acetic anhydride.
The term “cellulose acetate butyrate” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to any of several compounds obtained by treating cellulose with acetic anhydride and butyric anhydride.
The term “Nafion®” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to DuPont'"'"'s trademark of a sulfonated tetrafluorethylene polymer modified from Teflon® developed in the late 1960s. In general, Nafion® is a perfluorinated polymer that contains small proportions of sulfonic or carboxylic ionic functional groups.
The terms “crosslink” and “crosslinking” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to joining (adjacent chains of a polymer or protein) by creating covalent bonds. Crosslinking can be accomplished by techniques such as thermal reaction, chemical reaction or by providing ionizing radiation (for example, electron beam radiation, UV radiation, or gamma radiation). In preferred embodiments, crosslinking utilizes a technique that forms free radicals, for example, electron beam exposure. The term “ionizing radiation” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to radiation consisting of particles, X-ray beams, electron beams, UV beams, or gamma ray beams, which produce ions in the medium through which it passes.
The term “casting” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a process where a fluid material is applied to a surface or surfaces and allowed to cure or dry. The term is broad enough to encompass a variety of coating techniques, for example, using a draw-down machine (i.e., drawing-down), dip coating, spray coating, spin coating, or the like.
The term “dip coating” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to coating which involves spraying an object or material into a liquid coating substance.
The term “spray coating” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to coating which involves spraying a liquid coating substance onto an object or material.
The term “spin coating” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a coating process in which a thin film is created by dropping a raw material solution onto a substrate while it is rotating.
The terms “solvent” and “solvent systems” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to substances (e.g., liquids) capable of dissolving or dispersing one or more other substances. Solvents and solvent systems can include compounds and/or solutions that include components in addition to the solvent itself.
The term “baseline” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to the component of an analyte sensor signal that is not related to the analyte concentration. In one example of a glucose sensor, the baseline is composed substantially of signal contribution due to factors other than glucose (for example, interfering species, non-reaction-related hydrogen peroxide, or other electroactive species with an oxidation potential that overlaps with hydrogen peroxide). In some embodiments wherein a calibration is defined by solving for the equation y=m×+b, the value of b represents the baseline of the signal.
The terms “sensitivity” and “slope” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to an amount of electrical current produced by a predetermined amount (unit) of the measured analyte. For example, in one preferred embodiment, a sensor has a sensitivity (or slope) of about 3.5 to about 7.5 picoAmps of current for every 1 mg/dL of glucose analyte.
The terms “baseline and/or sensitivity shift,” “baseline and/or sensitivity drift,” “shift,” and “drift” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to a change in the baseline and/or sensitivity of the sensor signal over time. While the term “shift” generally refers to a substantially distinct change over a relatively short time period, and the term “drift” generally refers to a substantially gradual change over a relatively longer time period, the terms can be used interchangeably and can also be generally referred to as “change” in baseline and/or sensitivity.
The terms “sealant” and “lubricant” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and are not to be limited to a special or customized meaning), and refer without limitation to a material with a low surface tension that repels and/or blocks moisture, for example, oil, grease, or gel. Sealants or lubricants can be used to fill gaps and/or to repel or block water. One exemplary sealant is petroleum jelly.
Sensor System
The preferred embodiments relate to the use of an analyte sensor that measures a concentration of analyte of interest or a substance indicative of the concentration or presence of the analyte. In some embodiments, the sensor is a continuous device, for example a subcutaneous, transdermal (e.g., transcutaneous), or intravascular device. In some embodiments, the device can analyze a plurality of intermittent blood samples. The analyte sensor can use any method of analyte-sensing, including enzymatic, chemical, physical, electrochemical, spectrophotometric, polarimetric, calorimetric, radiometric, or the like.
The analyte sensor uses any method, including invasive, minimally invasive, and non-invasive sensing techniques, to provide an output signal indicative of the concentration of the analyte of interest. The output signal is typically a raw signal that is used to provide a useful value of the analyte of interest to a user, such as a patient or physician, who can be using the device. Accordingly, appropriate smoothing, calibration, and evaluation methods can be applied to the raw signal and/or system as a whole to provide relevant and acceptable estimated analyte data to the user.
The methods and devices of preferred embodiments can be employed in a continuous glucose sensor that measures a concentration of glucose or a substance indicative of a concentration or a presence of glucose. However, certain methods and devices of preferred embodiments are also suitable for use in connection with non-continuous (e.g., single point measurement or finger stick) monitors, such as the OneTouch® system manufactured by LifeScan, Inc., or monitors as disclosed in U.S. Pat. Nos. 5,418,142; 5,515,170; 5,526,120; 5,922,530; 5,968,836; and 6,335,203. In some embodiments, the glucose sensor is an invasive, minimally-invasive, or non-invasive device, for example a subcutaneous, transdermal, or intravascular device. In some embodiments, the device can analyze a plurality of intermittent biological samples, such as blood, interstitial fluid, or the like. The glucose sensor can use any method of glucose-measurement, including calorimetric, enzymatic, chemical, physical, electrochemical, spectrophotometric, polarimetric, calorimetric, radiometric, or the like. In alternative embodiments, the sensor can be any sensor capable of determining the level of an analyte in the body, for example oxygen, lactase, hormones, cholesterol, medicaments, viruses, or the like.
The glucose sensor uses any method to provide an output signal indicative of the concentration of the glucose. The output signal is typically a raw data stream that is used to provide a value indicative of the measured glucose concentration to a patient or doctor, for example.
One exemplary embodiment described in detail below utilizes an implantable glucose sensor. Another exemplary embodiment described in detail below utilizes a transcutaneous glucose sensor.
In one alternative embodiment, the continuous glucose sensor comprises a transcutaneous sensor such as described in U.S. Pat. No. 6,565,509 to Say et al. In another alternative embodiment, the continuous glucose sensor comprises a subcutaneous sensor such as described with reference to U.S. Pat. No. 6,579,690 to Bonnecaze et al. or U.S. Pat. No. 6,484,046 to Say et al. In another alternative embodiment, the continuous glucose sensor comprises a refillable subcutaneous sensor such as described with reference to U.S. Pat. No. 6,512,939 to Colvin et al. In another alternative embodiment, the continuous glucose sensor comprises an intravascular sensor such as described with reference to U.S. Pat. No. 6,477,395 to Schulman et al. In another alternative embodiment, the continuous glucose sensor comprises an intravascular sensor such as described with reference to U.S. Pat. No. 6,424,847 to Mastrototaro et al. All of the above patents are incorporated in their entirety herein by reference.
Although a few exemplary embodiments of continuous glucose sensors are illustrated and described herein, it should be understood that the disclosed embodiments are applicable to any device capable of single analyte, substantially continual or substantially continuous measurement of a concentration of analyte of interest and providing an output signal that represents the concentration of that analyte.
In a first exemplary embodiment, a transcutaneous analyte sensor system is provided that includes an applicator for inserting the transdermal analyte sensor under a host'"'"'s skin. The sensor system includes a sensor for sensing the analyte, wherein the sensor is associated with a mounting unit adapted for mounting on the skin of the host. The mounting unit houses the electronics unit associated with the sensor and is adapted for fastening to the host'"'"'s skin. In certain embodiments, the system further includes a receiver for receiving and/or processing sensor data.
The mounting unit (housing) 14 includes a base 24 adapted for mounting on the skin of a host, a sensor adapted for transdermal insertion through the skin of a host (see
In one embodiment, an applicator 12 is provided for inserting the sensor 32 through the host'"'"'s skin at the appropriate insertion angle with the aid of a needle (see
The electronics unit 16 includes hardware, firmware, and/or software that enable measurement of levels of the analyte via the sensor. For example, the electronics unit 16 can comprise a potentiostat, a power source for providing power to the sensor, other components useful for signal processing, and preferably an RF module for transmitting data from the electronics unit 16 to a receiver (see FIGS. 14 to 16). Electronics can be affixed to a printed circuit board (PCB), or the like, and can take a variety of forms. For example, the electronics can take the form of an integrated circuit (IC), such as an Application-Specific Integrated Circuit (ASIC), a microcontroller, or a processor. Preferably, electronics unit 16 houses the sensor electronics, which comprise systems and methods for processing sensor analyte data. Examples of systems and methods for processing sensor analyte data are described in more detail in U.S. Publication No. US-2005-0027463-A1.
After insertion of the sensor using the applicator 12, and subsequent release of the applicator 12 from the mounting unit 14 (see
Mounting Unit
In preferred embodiments, the mounting unit 14, also referred to as a housing, comprises a base 24 adapted for fastening to a host'"'"'s skin. The base can be formed from a variety of hard or soft materials, and preferably comprises a low profile for minimizing protrusion of the device from the host during use. In some embodiments, the base 24 is formed at least partially from a flexible material, which is believed to provide numerous advantages over conventional transcutaneous sensors, which, unfortunately, can suffer from motion-related artifacts associated with the host'"'"'s movement when the host is using the device. For example, when a transcutaneous analyte sensor is inserted into the host, various movements of the sensor (for example, relative movement between the in vivo portion and the ex vivo portion, movement of the skin, and/or movement within the host (dermis or subcutaneous)) create stresses on the device and can produce noise in the sensor signal. It is believed that even small movements of the skin can translate to discomfort and/or motion-related artifact, which can be reduced or obviated by a flexible or articulated base. Thus, by providing flexibility and/or articulation of the device against the host'"'"'s skin, better conformity of the sensor system 10 to the regular use and movements of the host can be achieved. Flexibility or articulation is believed to increase adhesion (with the use of an adhesive pad) of the mounting unit 14 onto the skin, thereby decreasing motion-related artifact that can otherwise translate from the host'"'"'s movements and reduced sensor performance.
In certain embodiments, the mounting unit 14 is provided with an adhesive pad 8, preferably disposed on the mounting unit'"'"'s back surface and preferably including a releasable backing layer 9. Thus, removing the backing layer 9 and pressing the base portion 24 of the mounting unit onto the host'"'"'s skin adheres the mounting unit 14 to the host'"'"'s skin. Additionally or alternatively, an adhesive pad can be placed over some or all of the sensor system after sensor insertion is complete to ensure adhesion, and optionally to ensure an airtight seal or watertight seal around the wound exit-site (or sensor insertion site) (not shown). Appropriate adhesive pads can be chosen and designed to stretch, elongate, conform to, and/or aerate the region (e.g., host'"'"'s skin).
In preferred embodiments, the adhesive pad 8 is formed from spun-laced, open- or closed-cell foam, and/or non-woven fibers, and includes an adhesive disposed thereon, however a variety of adhesive pads appropriate for adhesion to the host'"'"'s skin can be used, as is appreciated by one skilled in the art of medical adhesive pads. In some embodiments, a double-sided adhesive pad is used to adhere the mounting unit to the host'"'"'s skin. In other embodiments, the adhesive pad includes a foam layer, for example, a layer wherein the foam is disposed between the adhesive pad'"'"'s side edges and acts as a shock absorber.
In some embodiments, the surface area of the adhesive pad 8 is greater than the surface area of the mounting unit'"'"'s back surface. Alternatively, the adhesive pad can be sized with substantially the same surface area as the back surface of the base portion. Preferably, the adhesive pad has a surface area on the side to be mounted on the host'"'"'s skin that is greater than about 1, 1.25, 1.5, 1.75, 2, 2.25, or 2.5, times the surface area of the back surface 25 of the mounting unit base 24. Such a greater surface area can increase adhesion between the mounting unit and the host'"'"'s skin, minimize movement between the mounting unit and the host'"'"'s skin, and/or protect the wound exit-site (sensor insertion site) from environmental and/or biological contamination. In some alternative embodiments, however, the adhesive pad can be smaller in surface area than the back surface assuming a sufficient adhesion can be accomplished.
In some embodiments, the adhesive pad 8 is substantially the same shape as the back surface 25 of the base 24, although other shapes can also be advantageously employed, for example, butterfly-shaped, round, square, or rectangular. The adhesive pad backing can be designed for two-step release, for example, a primary release wherein only a portion of the adhesive pad is initially exposed to allow adjustable positioning of the device, and a secondary release wherein the remaining adhesive pad is later exposed to firmly and securely adhere the device to the host'"'"'s skin once appropriately positioned. The adhesive pad is preferably waterproof. Preferably, a stretch-release adhesive pad is provided on the back surface of the base portion to enable easy release from the host'"'"'s skin at the end of the useable life of the sensor, as is described in more detail with reference to
In some circumstances, it has been found that a conventional bond between the adhesive pad and the mounting unit may not be sufficient, for example, due to humidity that can cause release of the adhesive pad from the mounting unit. Accordingly, in some embodiments, the adhesive pad can be bonded using a bonding agent activated by or accelerated by an ultraviolet, acoustic, radio frequency, or humidity cure. In some embodiments, a eutectic bond of first and second composite materials can form a strong adhesion. In some embodiments, the surface of the mounting unit can be pretreated utilizing ozone, plasma, chemicals, or the like, in order to enhance the bondability of the surface.
A bioactive agent is preferably applied locally at the insertion site (exit-site) prior to or during sensor insertion. Suitable bioactive agents include those which are known to discourage or prevent bacterial growth and infection, for example, anti-inflammatory agents, antimicrobials, antibiotics, or the like. It is believed that the diffusion or presence of a bioactive agent can aid in prevention or elimination of bacteria adjacent to the exit-site. Additionally or alternatively, the bioactive agent can be integral with or coated on the adhesive pad, or no bioactive agent at all is employed.
Preferably, the sealing member is selected using a durometer. A durometer is an instrument used for measuring the indentation hardness of rubber, plastics, and other materials. Durometers are built to various standards from ASTM, DIN, JIS, and ISO. The hardness of plastics is most commonly measured by the Shore (Durometer) test or Rockwell hardness test. Both methods measure the resistance of plastics toward indentation and provide an empirical hardness value. Shore Hardness, using either the Shore A or Shore D scale, is the preferred method for rubbers/elastomers and is also commonly used for softer plastics such as polyolefins, fluoropolymers, and vinyls. The Shore A scale is used for softer rubbers while the Shore D scale is used for harder ones. In preferred embodiments, the Shore A scale is employed in connection with selection of a sealing member.
The Shore hardness is measured with a Durometer and sometimes referred to as “Durometer hardness.” The hardness value is determined by the penetration of the Durometer indenter foot into the sample. Because of the resilience of rubbers and plastics, the indentation reading may change over time, so the indentation time is sometimes reported along with the hardness number. The ASTM test method designation for the Shore Durometer hardness test is ASTM D2240. The results obtained from this test are a useful measure of relative resistance to indentation of various grades of polymers.
Using a durometer in the selection of a sealing member enables selection of a material with optimal durometer hardness that balances the advantages of a lower durometer hardness with the advantages of a higher durometer hardness. For example, when a guide tube (e.g., cannula) is utilized to maintain an opening in a silicone sealing member prior to sensor insertion, a compression set (e.g., some retention of a compressed shape caused by compression of the material over time) within the silicone can result due to compression over time of the sealing member by the guide tube. Compression set can also result from certain sterilization procedures (e.g., radiation sterilization such as electron beam or gamma radiation). Unfortunately, in some circumstances, the compression set of the sealing member may cause gaps or incompleteness of contact between the sealing member and the contacts and/or sensor. In general, a lower durometer hardness provides a better conformation (e.g., seal) surrounding the contacts and/or sensor as compared to a higher durometer hardness. Additionally, a lower durometer hardness enables a design wherein less force is required to create the seal (e.g., to snaphthe electronics unit into the mounting unit, for example, as in the embodiment illustrated in
It is generally preferred that a sealing member 36 with a durometer hardness of from about 5 to about 80 Shore A is employed, more preferably a durometer hardness of from about 10 to about 50 Shore A, and even more preferably from about 20 to about 50 Shore A. In one embodiment, of a transcutaneous analyte sensor, the sealing member is fabricated using a silicone of about 20 Shore A to maximize the conformance of the seal around the contacts and/or sensor while minimizing the force required to compress the silicone for that conformance. In another embodiment, the sealing member is formed from a silicone of about 50 Shore A so as to provide increased strength of the sealing member (e.g., its resistance to compression). While a few representative examples have been provided above, one skilled in the art appreciates that higher or lower durometer hardness sealing material may also be suitable for use.
In one alternative embodiment, a sealing member 36 with a durometer hardness of about 10 Shore A is used. In this embodiment, the sealing material tends to “weep” out, further increasing conformance of the seal against the adjacent parts. In another alternative embodiment, a sealing material with a durometer hardness of about 0 (zero) Shore A is used as a sealant and/or in combination with a sealant, also referred to as a lubricant, which in some embodiments is a hydrophobic fluid filling material such as a grease, silicone, petroleum jelly, or the like. Preferably, the sensor and/or contacts are encased in a housing that contains the sealant, causing the material to “squeeze” around contacts and/or sensor. Any suitable hydrophobic fluid filling material can be employed. Especially preferred are synthetic or petroleum hydrocarbon-based materials, silicone-based materials, ester-based greases, and other pharmaceutical-grade materials.
In some embodiments, the sealing member can comprise a material that has been modified to enhance the desirable properties of the sealing member 36. For example, one or more filler materials or stiffening agents such as glass beads, polymer beads, composite beads, beads comprising various inert materials, carbon black, talc, titanium oxide, silicone dioxide, and the like. In some embodiments, the filler material is incorporated into the sealing member material to mechanically stiffen the sealing member. In general, however, use of a filler material or stiffening agent in the sealing member material can provide a variety of enhanced properties including increased modulus of elasticity, crosslink density, hardness, and stiffness, and decreased creep, for example. In some alternative embodiments, gases are chemically (or otherwise) injected into the sealing member material. For example, the sealing material can comprise a polymeric foam (e.g., a polyurethane foam, a latex foam, a styrene-butadiene foam, and the like), or a dispersion of gas bubbles in a grease or jelly.
In alternative embodiments, the seal 36 is designed to form an interference fit with the electronics unit and can be formed from a variety of materials, for example, flexible plastics, or noble metals. One of ordinary skill in the art appreciates that a variety of designs can be employed to provide a seal surrounding electrical contacts such as described herein. For example, the contact holder 34 can be integrally designed as a part of the mounting unit, rather than as a separate piece thereof. Additionally or alternatively, a sealant can be provided in or around the sensor (e.g., within or on the contact subassembly or sealing member), such as is described in more detail with reference to
In the illustrated embodiment of
Contacts 28 fit within the seal 36 and provide for electrical connection between the sensor 32 and the electronics unit 16. In general, the contacts are designed to ensure a stable mechanical and electrical connection of the electrodes that form the sensor 32 (see
In preferred embodiments, the contacts 28 are formed from a conductive elastomeric material, such as a carbon black elastomer, through which the sensor 32 extends (see
In an alternative embodiment, a conductive, stiff plastic forms the contacts, which are shaped to comply upon application of pressure (for example, a leaf-spring shape). Contacts of such a configuration can be used instead of a metallic spring, for example, and advantageously avoid the need for crimping or soldering through compliant materials; additionally, a wiping action can be incorporated into the design to remove contaminants from the surfaces during connection. Non-metallic contacts can be advantageous because of their seamless manufacturability, robustness to thermal compression, non-corrosive surfaces, and native resistance to electrostatic discharge (ESD) damage due to their higher-than-metal resistance.
In certain circumstances, such as during sensor insertion or needle/guide tube retraction (see
In certain circumstances moisture may “wick” along the length of the sensor (e.g., from an exposed end) through the sealing member 36 to the contacts 28.
In some embodiments, gaps 400 can be filled by a sealant, which also may be referred to as a lubricant, for example, oil, grease, or gel. In one exemplary embodiment, the sealant includes petroleum jelly and is used to provide a moisture barrier surrounding the sensor. Referring to
In some sealing member configurations, it can be advantageous to provide a channel 406 through the sealing member 36 in order to create an additional pathway for sealant (e.g. lubricant) in order to expel air and/or to provide a path for excess sealant to escape. In some embodiments, more than one channel is provided.
Sensor
Preferably, the sensor 32 includes a distal portion 42, also referred to as the in vivo portion, adapted to extend out of the mounting unit for insertion under the host'"'"'s skin, and a proximal portion 40, also referred to as an ex vivo portion, adapted to remain above the host'"'"'s skin after sensor insertion and to operably connect to the electronics unit 16 via contacts 28. Preferably, the sensor 32 includes two or more electrodes: a working electrode 44 and at least one additional electrode, which can function as a counter electrode and/or reference electrode, hereinafter referred to as the reference electrode 46. A membrane system is preferably deposited over the electrodes, such as described in more detail with reference to
In alternative embodiments, the contacts 28 are formed into a variety of alternative shapes and/or sizes. For example, the contacts 28 can be discs, spheres, cuboids, and the like. Furthermore, the contacts 28 can be designed to extend from the mounting unit in a manner that causes an interference fit within a mating cavity or groove of the electronics unit, forming a stable mechanical and electrical connection therewith.
In preferred embodiments, each electrode is formed from a fine wire with a diameter of from about 0.001 or less to about 0.010 inches or more, for example, and is formed from, e.g., a plated insulator, a plated wire, or bulk electrically conductive material. Although the illustrated electrode configuration and associated text describe one preferred method of forming a transcutaneous sensor, a variety of known transcutaneous sensor configurations can be employed with the transcutaneous analyte sensor system of the preferred embodiments, such as U.S. Pat. No. 5,711,861 to Ward et al., U.S. Pat. No. 6,642,015 to Vachon et al., U.S. Pat. No. 6,654,625 to Say et al., U.S. Pat. No. 6,565,509 to Say et al., U.S. Pat. No. 6,514,718 to Heller, U.S. Pat. No. 6,465,066 to Essenpreis et al., U.S. Pat. No. 6,214,185 to Offenbacher et al., U.S. Pat. No. 5,310,469 to Cunningham et al., and U.S. Pat. No. 5,683,562 to Shaffer et al., U.S. Pat. No. 6,579,690 to Bonnecaze et al., U.S. Pat. No. 6,484,046 to Say et al., U.S. Pat. No. 6,512,939 to Colvin et al., U.S. Pat. No. 6,424,847 to Mastrototaro et al., U.S. Pat. No. 6,424,847 to Mastrototaro et al, for example. All of the above patents are incorporated in their entirety herein by reference and are not inclusive of all applicable analyte sensors; in general, it should be understood that the disclosed embodiments are applicable to a variety of analyte sensor configurations. It is noted that much of the description of the preferred embodiments, for example the membrane system described below, can be implemented not only with in vivo sensors, but also with in vitro sensors, such as blood glucose meters (SMBG).
In preferred embodiments, the working electrode comprises a wire formed from a conductive material, such as platinum, platinum-iridium, palladium, graphite, gold, carbon, conductive polymer, alloys, or the like. Although the electrodes can by formed by a variety of manufacturing techniques (bulk metal processing, deposition of metal onto a substrate, or the like), it can be advantageous to form the electrodes from plated wire (e.g., platinum on steel wire) or bulk metal (e.g., platinum wire). It is believed that electrodes formed from bulk metal wire provide superior performance (e.g, in contrast to deposited electrodes), including increased stability of assay, simplified manufacturability, resistance to contamination (e.g., which can be introduced in deposition processes), and improved surface reaction (e.g., due to purity of material) without peeling or delamination.
The working electrode 44 is configured to measure the concentration of an analyte. In an enzymatic electrochemical sensor for detecting glucose, for example, the working electrode measures the hydrogen peroxide produced by an enzyme catalyzed reaction of the analyte being detected and creates a measurable electronic current For example, in the detection of glucose wherein glucose oxidase produces hydrogen peroxide as a byproduct, hydrogen peroxide reacts with the surface of the working electrode producing two protons (2H+), two electrons (2e−) and one molecule of oxygen (O2), which produces the electronic current being detected.
In preferred embodiments, the working electrode 44 is covered with an insulating material 45, for example, a non-conductive polymer. Dip-coating, spray-coating, vapor-deposition, or other coating or deposition techniques can be used to deposit the insulating material on the working electrode. In one embodiment, the insulating material comprises parylene, which can be an advantageous polymer coating for its strength, lubricity, and electrical insulation properties. Generally, parylene is produced by vapor deposition and polymerization of para-xylylene (or its substituted derivatives). While not wishing to be bound by theory, it is believed that the lubricious (e.g., smooth) coating (e.g., parylene) on the sensors of the preferred embodiments contributes to minimal trauma and extended sensor life.
The reference electrode 46, which can function as a reference electrode alone, or as a dual reference and counter electrode, is formed from silver, silver/silver chloride, or the like. Preferably, the reference electrode 46 is juxtapositioned and/or twisted with or around the working electrode 44; however other configurations are also possible (e.g., an intradermal or on-skin reference electrode). In the illustrated embodiments, the reference electrode 46 is helically wound around the working electrode 44. The assembly of wires is then optionally coated or adhered together with an insulating material, similar to that described above, so as to provide an insulating attachment.
In some embodiments, a silver wire is formed onto the sensor as described above, and subsequently chloridized to form silver/silver chloride reference electrode. Advantageously, chloridizing the silver wire as described herein enables the manufacture of a reference electrode with optimal in vivo performance. Namely, by controlling the quantity and amount of chloridization of the silver to form silver/silver chloride, improved break-in time, stability of the reference electrode, and extended life has been shown with the preferred embodiments (see
In embodiments wherein an outer insulator is disposed, a portion of the coated assembly structure can be stripped or otherwise removed, for example, by hand, excimer lasing, chemical etching, laser ablation, grit-blasting (e.g., with sodium bicarbonate or other suitable grit), or the like, to expose the electroactive surfaces. Alternatively, a portion of the electrode can be masked prior to depositing the insulator in order to maintain an exposed electroactive surface area. In one exemplary embodiment, grit blasting is implemented to expose the electroactive surfaces, preferably utilizing a grit material that is sufficiently hard to ablate the polymer material, while being sufficiently soft so as to minimize or avoid damage to the underlying metal electrode (e.g., a platinum electrode). Although a variety of “grit” materials can be used (e.g., sand, talc, walnut shell, ground plastic, sea salt, and the like), in some preferred embodiments, sodium bicarbonate is an advantageous grit-material because it is sufficiently hard to ablate, e.g., a parylene coating without damaging, e.g., an underlying platinum conductor. One additional advantage of sodium bicarbonate blasting includes its polishing action on the metal as it strips the polymer layer, thereby eliminating a cleaning step that might otherwise be necessary.
In the embodiment illustrated in
In some applications, cellular attack or migration of cells to the sensor can cause reduced sensitivity and/or function of the device, particularly after the first day of implantation. However, when the exposed electroactive surface is distributed circumferentially about the sensor (e.g., as in a radial window), the available surface area for reaction can be sufficiently distributed so as to minimize the effect of local cellular invasion of the sensor on the sensor signal. Alternatively, a tangential exposed electroactive window can be formed, for example, by stripping only one side of the coated assembly structure. In other alternative embodiments, the window can be provided at the tip of the coated assembly structure such that the electroactive surfaces are exposed at the tip of the sensor. Other methods and configurations for exposing electroactive surfaces can also be employed.
In some embodiments, the working electrode has a diameter of from about 0.001 inches or less to about 0.010 inches or more, preferably from about 0.002 inches to about 0.008 inches, and more preferably from about 0.004 inches to about 0.005 inches. The length of the window can be from about 0.1 mm (about 0.004 inches) or less to about 2 mm (about 0.078 inches) or more, and preferably from about 0.5 mm (about 0.02 inches) to about 0.75 mm (0.03 inches). In such embodiments, the exposed surface area of the working electrode is preferably from about 0.000013 in2 (0.0000839 cm2) or less to about 0.0025 in2 (0.016129 cm2) or more (assuming a diameter of from about 0.001 inches to about 0.010 inches and a length of from about 0.004 inches to about 0.078 inches). The preferred exposed surface area of the working electrode is selected to produce an analyte signal with a current in the picoAmp range, such as is described in more detail elsewhere herein. However, a current in the picoAmp range can be dependent upon a variety of factors, for example the electronic circuitry design (e.g., sample rate, current draw, A/D converter bit resolution, etc.), the membrane system (e.g., permeability of the analyte through the membrane system), and the exposed surface area of the working electrode. Accordingly, the exposed electroactive working electrode surface area can be selected to have a value greater than or less than the above-described ranges taking into consideration alterations in the membrane system and/or electronic circuitry. In preferred embodiments of a glucose sensor, it can be advantageous to minimize the surface area of the working electrode while maximizing the diffusivity of glucose in order to optimize the signal-to-noise ratio while maintaining sensor performance in both high and low glucose concentration ranges.
In some alternative embodiments, the exposed surface area of the working (and/or other) electrode can be increased by altering the cross-section of the electrode itself. For example, in some embodiments the cross-section of the working electrode can be defined by a cross, star, cloverleaf, ribbed, dimpled, ridged, irregular, or other non-circular configuration; thus, for any predetermined length of electrode, a specific increased surface area can be achieved (as compared to the area achieved by a circular cross-section). Increasing the surface area of the working electrode can be advantageous in providing an increased signal responsive to the analyte concentration, which in turn can be helpful in improving the signal-to-noise ratio, for example.
In some alternative embodiments, additional electrodes can be included within the assembly, for example, a three-electrode system (working, reference, and counter electrodes) and/or an additional working electrode (e.g., an electrode which can be used to generate oxygen, which is configured as a baseline subtracting electrode, or which is configured for measuring additional analytes). U.S. Publication No. US-2005-0161346-A1 and U.S. Publication No. US-2005-0143635-A1 describe some systems and methods for implementing and using additional working, counter, and/or reference electrodes. In one implementation wherein the sensor comprises two working electrodes, the two working electrodes are juxtapositioned (e.g., extend parallel to each other), around which the reference electrode is disposed (e.g., helically wound). In some embodiments wherein two or more working electrodes are provided, the working electrodes can be formed in a double-, triple-, quad-, etc. helix configuration along the length of the sensor (for example, surrounding a reference electrode, insulated rod, or other support structure). The resulting electrode system can be configured with an appropriate membrane system, wherein the first working electrode is configured to measure a first signal comprising glucose and baseline and the additional working electrode is configured to measure a baseline signal consisting of baseline only (e.g., configured to be substantially similar to the first working electrode without an enzyme disposed thereon). In this way, the baseline signal can be subtracted from the first signal to produce a glucose-only signal that is substantially not subject to fluctuations in the baseline and/or interfering species on the signal.
Although the preferred embodiments illustrate one electrode configuration including one bulk metal wire helically wound around another bulk metal wire, other electrode configurations are also contemplated. In an alternative embodiment, the working electrode comprises a tube with a reference electrode disposed or coiled inside, including an insulator therebetween. Alternatively, the reference electrode comprises a tube with a working electrode disposed or coiled inside, including an insulator therebetween. In another alternative embodiment, a polymer (e.g., insulating) rod is provided, wherein the electrodes are deposited (e.g., electroplated) thereon. In yet another alternative embodiment, a metallic (e.g., steel) rod is provided, coated with an insulating material, onto which the working and reference electrodes are deposited. In yet another alternative embodiment, one or more working electrodes are helically wound around a reference electrode.
Preferably, the electrodes and membrane systems of the preferred embodiments are coaxially formed, namely, the electrodes and/or membrane system all share the same central axis. While not wishing to be bound by theory, it is believed that a coaxial design of the sensor enables a symmetrical design without a preferred bend radius. Namely, in contrast to prior art sensors comprising a substantially planar configuration that can suffer from regular bending about the plane of the sensor, the coaxial design of the preferred embodiments do not have a preferred bend radius and therefore are not subject to regular bending about a particular plane (which can cause fatigue failures and the like). However, non-coaxial sensors can be implemented with the sensor system of the preferred embodiments.
In addition to the above-described advantages, the coaxial sensor design of the preferred embodiments enables the diameter of the connecting end of the sensor (proximal portion) to be substantially the same as that of the sensing end (distal portion) such that the needle is able to insert the sensor into the host and subsequently slide back over the sensor and release the sensor from the needle, without slots or other complex multi-component designs.
In one such alternative embodiment, the two wires of the sensor are held apart and configured for insertion into the host in proximal but separate locations. The separation of the working and reference electrodes in such an embodiment can provide additional electrochemical stability with simplified manufacture and electrical connectivity. It is appreciated by one skilled in the art that a variety of electrode configurations can be implemented with the preferred embodiments.
In some embodiments, the sensor includes an antimicrobial portion configured to extend through the exit-site when the sensor is implanted in the host. Namely, the sensor is designed with in vivo and ex vivo portions as described in more detail elsewhere herein; additionally, the sensor comprises a transition portion, also referred to as an antimicrobial portion, located between the in vivo and ex vivo portions 42, 40. The antimicrobial portion is designed to provide antimicrobial effects to the exit-site and adjacent tissue when implanted in the host.
In some embodiments, the antimicrobial portion comprises silver, e.g., the portion of a silver reference electrode that is configured to extend through the exit-site when implanted. Although exit-site infections are a common adverse occurrence associated with some conventional transcutaneous medical devices, the devices of preferred embodiments are designed at least in part to minimize infection, to minimize irritation, and/or to extend the duration of implantation of the sensor by utilizing a silver reference electrode to extend through the exit-site when implanted in a patient. While not wishing to be bound by theory, it is believed that the silver may reduce local tissue infections (within the tissue and at the exit-site); namely, steady release of molecular quantities of silver is believed to have an antimicrobial effect in biological tissue (e.g., reducing or preventing irritation and infection), also referred to as passive antimicrobial effects. Although one example of passive antimicrobial effects is described herein, one skilled in the art can appreciate a variety of passive anti-microbial systems and methods that can be implemented with the preferred embodiments. Additionally, it is believed that antimicrobial effects can contribute to extended life of a transcutaneous analyte sensor, enabling a functional lifetime past a few days, e.g., seven days or longer.
In some embodiments, active antimicrobial systems and methods are provided in the sensor system in order to further enhance the antimicrobial effects at the exit-site. In one such embodiment, an auxiliary silver wire is disposed on or around the sensor, wherein the auxiliary silver wire is connected to electronics and configured to pass a current sufficient to enhance its antimicrobial properties (active antimicrobial effects), as is appreciated by one skilled in the art. The current can be passed continuously or intermittently, such that sufficient antimicrobial properties are provided. Although one example of active antimicrobial effects is described herein, one skilled in the art can appreciate a variety of active anti-microbial systems and methods that can be implemented with the preferred embodiments.
Anchoring Mechanism
It is preferred that the sensor remains substantially stationary within the tissue of the host, such that migration or motion of the sensor with respect to the surrounding tissue is minimized. Migration or motion is believed to cause inflammation at the sensor implant site due to irritation, and can also cause noise on the sensor signal due to motion-related artifact, for example. Therefore, it can be advantageous to provide an anchoring mechanism that provides support for the sensor'"'"'s in vivo portion to avoid the above-mentioned problems. Combining advantageous sensor geometry with an advantageous anchoring minimizes additional parts and allows for an optimally small or low profile design of the sensor. In one embodiment the sensor includes a surface topography, such as the helical surface topography provided by the reference electrode surrounding the working electrode. In alternative embodiments, a surface topography could be provided by a roughened surface, porous surface (e.g porous parylene), ridged surface, or the like. Additionally (or alternatively), the anchoring can be provided by prongs, spines, barbs, wings, hooks, a bulbous portion (for example, at the distal end), an S-bend along the sensor, a rough surface topography, a gradually changing diameter, combinations thereof, or the like, which can be used alone or in combination with the helical surface topography to stabilize the sensor within the subcutaneous tissue.
Variable Stiffness
As described above, conventional transcutaneous devices are believed to suffer from motion artifact associated with host movement when the host is using the device. For example, when a transcutaneous analyte sensor is inserted into the host, various movements on the sensor (for example, relative movement within and between the subcutaneous space, dermis, skin, and external portions of the sensor) create stresses on the device, which is known to produce artifacts on the sensor signal. Accordingly, there are different design considerations (for example, stress considerations) on various sections of the sensor. For example, the distal portion 42 of the sensor can benefit in general from greater flexibility as it encounters greater mechanical stresses caused by movement of the tissue within the patient and relative movement between the in vivo and ex vivo portions of the sensor. On the other hand, the proximal portion 40 of the sensor can benefit in general from a stiffer, more robust design to ensure structural integrity and/or reliable electrical connections. Additionally, in some embodiments wherein a needle is retracted over the proximal portion 40 of the device (see FIGS. 6 to 8), a stiffer design can minimize crimping of the sensor and/or ease in retraction of the needle from the sensor. Thus, by designing greater flexibility into the in vivo (distal) portion 42, the flexibility is believed to compensate for patient movement, and noise associated therewith. By designing greater stiffness into the ex vivo (proximal) portion 40, column strength (for retraction of the needle over the sensor), electrical connections, and integrity can be enhanced. In some alternative embodiments, a stiffer distal end and/or a more flexible proximal end can be advantageous as described in U.S. Publication No. US-2006-0015024-A1.
The preferred embodiments provide a distal portion 42 of the sensor 32 designed to be more flexible than a proximal portion 40 of the sensor. The variable stiffness of the preferred embodiments can be provided by variable pitch of any one or more helically wound wires of the device, variable cross-section of any one or more wires of the device, and/or variable hardening and/or softening of any one or more wires of the device, such as is described in more detail with reference to U.S. Publication No. US-2006-0015024-A1.
Membrane System
In general, the membrane system includes a plurality of domains, for example, an electrode domain 47, an interference domain 48, an enzyme domain 49 (for example, including glucose oxidase), and a resistance domain 50, as shown in
In some embodiments, one or more domains of the membrane systems are formed from materials such as described above in connection with the porous layer, such as silicone, polytetrafluoroethylene, polyethylene-co-tetrafluoroethylene, polyolefin, polyester, polycarbonate, biostable polytetrafluoroethylene, homopolymers, copolymers, terpolymers of polyurethanes, polypropylene (PP), polyvinylchloride (PVC), polyvinylidene fluoride (PVDF), polybutylene terephthalate (PBT), polymethylmethacrylate (PMMA), polyether ether ketone (PEEK), polyurethanes, cellulosic polymers, polysulfones and block copolymers thereof including, for example, di-block, tri-block, alternating, random and graft copolymers. U.S. Publication No. US-2005-0245799-A1 describes biointerface and membrane system configurations and materials that may be applied to the preferred embodiments.
Electrode Domain
In selected embodiments, the membrane system comprises an electrode domain. The electrode domain 47 is provided to ensure that an electrochemical reaction occurs between the electroactive surfaces of the working electrode and the reference electrode, and thus the electrode domain 47 is preferably situated more proximal to the electroactive surfaces than the interference and/or enzyme domain. Preferably, the electrode domain includes a coating that maintains a layer of water at the electrochemically reactive surfaces of the sensor. In other words, the electrode domain is present to provide an environment between the surfaces of the working electrode and the reference electrode which facilitates an electrochemical reaction between the electrodes. For example, a humectant in a binder material can be employed as an electrode domain; this allows for the full transport of ions in the aqueous environment. The electrode domain can also assist in stabilizing the operation of the sensor by accelerating electrode start-up and drifting problems caused by inadequate electrolyte. The material that forms the electrode domain can also provide an environment that protects against pH-mediated damage that can result from the formation of a large pH gradient due to the electrochemical activity of the electrodes.
In one embodiment, the electrode domain 47 includes a flexible, water-swellable, hydrogel film having a “dry film” thickness of from about 0.05 micron or less to about 20 microns or more, more preferably from about 0.05, 0.1, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 1, 1.5, 2, 2.5, 3, or 3.5 microns to about 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 19.5 microns, and more preferably still from about 2, 2.5 or 3 microns to about 3.5, 4, 4.5, or 5 microns. “Dry film” thickness refers to the thickness of a cured film cast from a coating formulation by standard coating techniques.
In certain embodiments, the electrode domain 47 is formed of a curable mixture of a urethane polymer and a hydrophilic polymer. Particularly preferred coatings are formed of a polyurethane polymer having carboxylate or hydroxyl functional groups and non-ionic hydrophilic polyether segments, wherein the polyurethane polymer is crosslinked with a water soluble carbodiimide (e.g., 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide (EDC)) in the presence of polyvinylpyrrolidone and cured at a moderate temperature of about 50° C.
In some preferred embodiments, the electrode domain 47 is formed from a hydrophilic polymer such as polyvinylpyrrolidone (PVP). An electrode domain formed from PVP has been shown to reduce break-in time of analyte sensors; for example, a glucose sensor utilizing a cellulosic-based interference domain such as described in more detail below.
Preferably, the electrode domain is deposited by vapor deposition, spray coating, dip coating, or other thin film techniques on the electroactive surfaces of the sensor. In one preferred embodiment, the electrode domain is formed by dip-coating the electroactive surfaces in an electrode layer solution and curing the domain for a time of from about 15 minutes to about 30 minutes at a temperature of from about 40° C. to about 55° C. (and can be accomplished under vacuum (e.g., 20 to 30 mmHg)). In embodiments wherein dip-coating is used to deposit the electrode domain, a preferred insertion rate of from about 1 to about 3 inches per minute into the electrode layer solution, with a preferred dwell time of from about 0.5 to about 2 minutes in the electrode layer solution, and a preferred withdrawal rate of from about 0.25 to about 2 inches per minute from the electrode layer solution provide a functional coating. However, values outside of those set forth above can be acceptable or even desirable in certain embodiments, for example, depending upon solution viscosity and solution surface tension, as is appreciated by one skilled in the art. In one embodiment, the electroactive surfaces of the electrode system are dip-coated one time (one layer) and cured at 50° C. under vacuum for 20 minutes.
Although an independent electrode domain 47 is described herein, in some embodiments sufficient hydrophilicity can be provided in the interference domain and/or enzyme domain (the domain adjacent to the electroactive surfaces) so as to provide for the full transport of ions in the aqueous environment (e.g. without a distinct electrode domain). In these embodiments, an electrode domain is not necessary.
Interference Domain
Interferents are molecules or other species that are reduced or oxidized at the electrochemically reactive surfaces of the sensor, either directly or via an electron transfer agent, to produce a false positive analyte signal. In preferred embodiments, an interference domain 48 is provided that substantially restricts, resists, or blocks the flow of one or more interfering species. Some known interfering species for a glucose sensor, as described in more detail above, include acetaminophen, ascorbic acid, bilirubin, cholesterol, creatinine, dopamine, ephedrine, ibuprofen, L-dopa, methyl dopa, salicylate, tetracycline, tolazamide, tolbutamide, triglycerides, and uric acid. In general, the interference domain of the preferred embodiments is less permeable to one or more of the interfering species than to the analyte, e.g., glucose.
In one embodiment, the interference domain 48 is formed from one or more cellulosic derivatives. In general, cellulosic derivatives include polymers such as cellulose acetate, cellulose acetate butyrate, 2-hydroxyethyl cellulose, cellulose acetate phthalate, cellulose acetate propionate, cellulose acetate trimellitate, and the like.
In one preferred embodiment, the interference domain 48 is formed from cellulose acetate butyrate. Cellulose acetate butyrate with a molecular weight of about 10,000 daltons to about 75,000 daltons, preferably from about 15,000, 20,000, or 25,000 daltons to about 50,000, 55,000, 60,000, 65,000, or 70,000 daltons, and more preferably about 20,000 daltons is employed. In certain embodiments, however, higher or lower molecular weights can be preferred. Additionally, a casting solution or dispersion of cellulose acetate butyrate at a weight percent of about 15% to about 25%, preferably from about 15%, 16%, 17%, 18%, 19% to about 20%, 21%, 22%, 23%, 24% or 25%, and more preferably about 18% is preferred. Preferably, the casting solution includes a solvent or solvent system, for example an acetone:ethanol solvent system. Higher or lower concentrations can be preferred in certain embodiments. A plurality of layers of cellulose acetate butyrate can be advantageously combined to form the interference domain in some embodiments, for example, three layers can be employed. It can be desirable to employ a mixture of cellulose acetate butyrate components with different molecular weights in a single solution, or to deposit multiple layers of cellulose acetate butyrate from different solutions comprising cellulose acetate butyrate of different molecular weights, different concentrations, and/or different chemistries (e.g., functional groups). It can also be desirable to include additional substances in the casting solutions or dispersions, e.g., functionalizing agents, crosslinking agents, other polymeric substances, substances capable of modifying the hydrophilicity/hydrophobicity of the resulting layer, and the like.
In one alternative embodiment, the interference domain 48 is formed from cellulose acetate. Cellulose acetate with a molecular weight of about 30,000 daltons or less to about 100,000 daltons or more, preferably from about 35,000, 40,000, or 45,000 daltons to about 55,000, 60,000, 65,000, 70,000, 75,000, 80,000, 85,000, 90,000, or 95,000 daltons, and more preferably about 50,000 daltons is preferred. Additionally, a casting solution or dispersion of cellulose acetate at a weight percent of about 3% to about 10%, preferably from about 3.5%, 4.0%, 4.5%, 5.0%, 5.5%, 6.0%, or 6.5% to about 7.5%, 8.0%, 8.5%, 9.0%, or 9.5%, and more preferably about 8% is preferred. In certain embodiments, however, higher or lower molecular weights and/or cellulose acetate weight percentages can be preferred. It can be desirable to employ a mixture of cellulose acetates with molecular weights in a single solution, or to deposit multiple layers of cellulose acetate from different solutions comprising cellulose acetates of different molecular weights, different concentrations, or different chemistries (e.g., functional groups). It can also be desirable to include additional substances in the casting solutions or dispersions such as described in more detail above.
Layer(s) prepared from combinations of cellulose acetate and cellulose acetate butyrate, or combinations of layer(s) of cellulose acetate and layer(s) of cellulose acetate butyrate can also be employed to form the interference domain 48.
In some alternative embodiments, additional polymers, such as Nafion®, can be used in combination with cellulosic derivatives to provide equivalent and/or enhanced function of the interference domain 48. As one example, a 5 wt % Nafion® casting solution or dispersion can be used in combination with a 8 wt % cellulose acetate casting solution or dispersion, e.g., by dip coating at least one layer of cellulose acetate and subsequently dip coating at least one layer Nafion® onto a needle-type sensor such as described with reference to the preferred embodiments. Any number of coatings or layers formed in any order may be suitable for forming the interference domain of the preferred embodiments.
In some alternative embodiments, more than one cellulosic derivative can be used to form the interference domain 48 of the preferred embodiments. In general, the formation of the interference domain on a surface utilizes a solvent or solvent system in order to solvate the cellulosic derivative (or other polymer) prior to film formation thereon. In preferred embodiments, acetone and ethanol are used as solvents for cellulose acetate; however one skilled in the art appreciates the numerous solvents that are suitable for use with cellulosic derivatives (and other polymers). Additionally, one skilled in the art appreciates that the preferred relative amounts of solvent can be dependent upon the cellulosic derivative (or other polymer) used, its molecular weight, its method of deposition, its desired thickness, and the like. However, a percent solute of from about 1% to about 25% is preferably used to form the interference domain solution so as to yield an interference domain having the desired properties. The cellulosic derivative (or other polymer) used, its molecular weight, method of deposition, and desired thickness can be adjusted, depending upon one or more other of the parameters, and can be varied accordingly as is appreciated by one skilled in the art.
In some alternative embodiments, other polymer types that can be utilized as a base material for the interference domain 48 including polyurethanes, polymers having pendant ionic groups, and polymers having controlled pore size, for example. In one such alternative embodiment, the interference domain includes a thin, hydrophobic membrane that is non-swellable and restricts diffusion of low molecular weight species. The interference domain 48 is permeable to relatively low molecular weight substances, such as hydrogen peroxide, but restricts the passage of higher molecular weight substances, including glucose and ascorbic acid. Other systems and methods for reducing or eliminating interference species that can be applied to the membrane system of the preferred embodiments are described in U.S. Publication No. US-2005-0115832-A1, U.S. Publication No. US-2005-0176136-A1, U.S. Publication No. US-2005-0161346-A1, and U.S. Publication No. US-2005-0143635-A1. In some alternative embodiments, a distinct interference domain is not included.
In preferred embodiments, the interference domain 48 is deposited directly onto the electroactive surfaces of the sensor for a domain thickness of from about 0.05 micron or less to about 20 microns or more, more preferably from about 0.05, 0.1, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 1, 1.5, 2, 2.5, 3, or 3.5 microns to about 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 19.5 microns, and more preferably still from about 1, 1.5 or 2 microns to about 2.5 or 3 microns. Thicker membranes can also be desirable in certain embodiments, but thinner membranes are generally preferred because they have a lower impact on the rate of diffusion of hydrogen peroxide from the enzyme membrane to the electrodes.
In general, the membrane systems of the preferred embodiments can be formed and/or deposited on the exposed electroactive surfaces (e.g., one or more of the working and reference electrodes) using known thin film techniques (for example, casting, spray coating, drawing down, electro-depositing, dip coating, and the like), however casting or other known application techniques can also be utilized. Preferably, the interference domain is deposited by vapor deposition, spray coating, or dip coating. In one exemplary embodiment of a needle-type (transcutaneous) sensor such as described herein, the interference domain is formed by dip coating the sensor into an interference domain solution using an insertion rate of from about 20 inches/min to about 60 inches/min, preferably 40 inches/min, a dwell time of from about 0 minute to about 5 seconds, preferably 0 seconds, and a withdrawal rate of from about 20 inches/minute to about 60 inches/minute, preferably about 40 inches/minute, and curing (drying) the domain from about 1 minute to about 30 minutes, preferably from about 3 minutes to about 15 minutes (and can be accomplished at room temperature or under vacuum (e.g., 20 to 30 mmHg)). In one exemplary embodiment including cellulose acetate butyrate interference domain, a 3-minute cure (i.e., dry) time is preferred between each layer applied. In another exemplary embodiment employing a cellulose acetate interference domain, a 15 minute cure (i.e., dry) time is preferred between each layer applied.
The dip process can be repeated at least one time and up to 10 times or more. The preferred number of repeated dip processes depends upon the cellulosic derivative(s) used, their concentration, conditions during deposition (e.g., dipping) and the desired thickness (e.g., sufficient thickness to provide functional blocking of (or resistance to) certain interferents), and the like. In some embodiments, 1 to 3 microns may be preferred for the interference domain thickness; however, values outside of these can be acceptable or even desirable in certain embodiments, for example, depending upon viscosity and surface tension, as is appreciated by one skilled in the art. In one exemplary embodiment, an interference domain is formed from three layers of cellulose acetate butyrate. In another exemplary embodiment, an interference domain is formed from 10 layers of cellulose acetate. In alternative embodiments, the interference domain can be formed using any known method and combination of cellulose acetate and cellulose acetate butyrate, as will be appreciated by one skilled in the art.
In some embodiments, the electroactive surface can be cleaned prior to application of the interference domain 48. In some embodiments, the interference domain 48 of the preferred embodiments can be useful as a bioprotective or biocompatible domain, namely, a domain that interfaces with host tissue when implanted in an animal (e.g., a human) due to its stability and biocompatibility.
Enzyme Domain
In preferred embodiments, the membrane system further includes an enzyme domain 49 disposed more distally from the electroactive surfaces than the interference domain 48; however other configurations can be desirable. In the preferred embodiments, the enzyme domain provides an enzyme to catalyze the reaction of the analyte and its co-reactant, as described in more detail below. In the preferred embodiments of a glucose sensor, the enzyme domain includes glucose oxidase; however other oxidases, for example, galactose oxidase or uricase oxidase, can also be used.
For an enzyme-based electrochemical glucose sensor to perform well, the sensor'"'"'s response is preferably limited by neither enzyme activity nor co-reactant concentration. Because enzymes, including glucose oxidase, are subject to deactivation as a function of time even in ambient conditions, this behavior is compensated for in forming the enzyme domain. Preferably, the enzyme domain is constructed of aqueous dispersions of colloidal polyurethane polymers including the enzyme. However, in alternative embodiments the enzyme domain is constructed from an oxygen enhancing material, for example, silicone, or fluorocarbon, in order to provide a supply of excess oxygen during transient ischemia. Preferably, the enzyme is immobilized within the domain. See, e.g., U.S. patent application Ser. No. 10/896,639 filed on Jul. 21, 2004 and entitled “Oxygen Enhancing Membrane Systems for Implantable Device.”
In preferred embodiments, the enzyme domain is deposited onto the interference domain for a domain thickness of from about 0.05 micron or less to about 20 microns or more, more preferably from about 0.05, 0.1, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 1, 1.5, 2, 2.5, 3, or 3.5 microns to about 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 19.5 microns, and more preferably still from about 2, 2.5 or 3 microns to about 3.5, 4, 4.5, or 5 microns. However in some embodiments, the enzyme domain can be deposited directly onto the electroactive surfaces. Preferably, the enzyme domain is deposited by spray or dip coating. In one embodiment of needle-type (transcutaneous) sensor such as described herein, the enzyme domain is formed by dip coating the interference domain coated sensor into an enzyme domain solution and curing the domain for from about 15 to about 30 minutes at a temperature of from about 40° C. to about 55° C. (and can be accomplished under vacuum (e.g., 20 to 30 mmHg)). In embodiments wherein dip coating is used to deposit the enzyme domain at room temperature, a preferred insertion rate of from about 0.25 inch per minute to about 3 inches per minute, with a preferred dwell time of from about 0.5 minutes to about 2 minutes, and a preferred withdrawal rate of from about 0.25 inch per minute to about 2 inches per minute provides a functional coating. However, values outside of those set forth above can be acceptable or even desirable in certain embodiments, for example, depending upon viscosity and surface tension, as is appreciated by one skilled in the art. In one embodiment, the enzyme domain is formed by dip coating two times (namely, forming two layers) in an enzyme domain solution and curing at 50° C. under vacuum for 20 minutes. However, in some embodiments, the enzyme domain can be formed by dip coating and/or spray coating one or more layers at a predetermined concentration of the coating solution, insertion rate, dwell time, withdrawal rate, and/or desired thickness.
Resistance Domain
In preferred embodiments, the membrane system includes a resistance domain 50 disposed more distal from the electroactive surfaces than the enzyme domain. Although the following description is directed to a resistance domain for a glucose sensor, the resistance domain can be modified for other analytes and co-reactants as well.
There exists a molar excess of glucose relative to the amount of oxygen in blood; that is, for every free oxygen molecule in extracellular fluid, there are typically more than 100 glucose molecules present (see Updike et al., Diabetes Care 5:207-21(1982)). However, an immobilized enzyme-based glucose sensor employing oxygen as co-reactant is preferably supplied with oxygen in non-rate-limiting excess in order for the sensor to respond linearly to changes in glucose concentration, while not responding to changes in oxygen concentration. Specifically, when a glucose-monitoring reaction is oxygen limited, linearity is not achieved above minimal concentrations of glucose. Without a semipermeable membrane situated over the enzyme domain to control the flux of glucose and oxygen, a linear response to glucose levels can be obtained only for glucose concentrations of up to about 40 mg/dL. However, in a clinical setting, a linear response to glucose levels is desirable up to at least about 400 mg/dL.
The resistance domain includes a semipermeable membrane that controls the flux of oxygen and glucose to the underlying enzyme domain, preferably rendering oxygen in a non-rate-limiting excess. As a result, the upper limit of linearity of glucose measurement is extended to a much higher value than that which is achieved without the resistance domain. In one embodiment, the resistance domain exhibits an oxygen to glucose permeability ratio of from about 50:1 or less to about 400:1 or more, preferably about 200:1. As a result, one-dimensional reactant diffusion is adequate to provide excess oxygen at all reasonable glucose and oxygen concentrations found in the subcutaneous matrix (See Rhodes et al., Anal. Chem., 66:1520-1529 (1994)).
In alternative embodiments, a lower ratio of oxygen-to-glucose can be sufficient to provide excess oxygen by using a high oxygen solubility domain (for example, a silicone or fluorocarbon-based material or domain) to enhance the supply/transport of oxygen to the enzyme domain. If more oxygen is supplied to the enzyme, then more glucose can also be supplied to the enzyme without creating an oxygen rate-limiting excess. In alternative embodiments, the resistance domain is formed from a silicone composition, such as is described in U.S. Publication No. US-2005-0090607-A1.
In a preferred embodiment, the resistance domain includes a polyurethane membrane with both hydrophilic and hydrophobic regions to control the diffusion of glucose and oxygen to an analyte sensor, the membrane being fabricated easily and reproducibly from commercially available materials. A suitable hydrophobic polymer component is a polyurethane, or polyetherurethaneurea. Polyurethane is a polymer produced by the condensation reaction of a diisocyanate and a difunctional hydroxyl-containing material. A polyurethaneurea is a polymer produced by the condensation reaction of a diisocyanate and a difunctional amine-containing material. Preferred diisocyanates include aliphatic diisocyanates containing from about 4 to about 8 methylene units. Diisocyanates containing cycloaliphatic moieties can also be useful in the preparation of the polymer and copolymer components of the membranes of preferred embodiments. The material that forms the basis of the hydrophobic matrix of the resistance domain can be any of those known in the art as appropriate for use as membranes in sensor devices and as having sufficient permeability to allow relevant compounds to pass through it, for example, to allow an oxygen molecule to pass through the membrane from the sample under examination in order to reach the active enzyme or electrochemical electrodes. Examples of materials which can be used to make non-polyurethane type membranes include vinyl polymers, polyethers, polyesters, polyamides, inorganic polymers such as polysiloxanes and polycarbosiloxanes, natural polymers such as cellulosic and protein based materials, and mixtures or combinations thereof.
In a preferred embodiment, the hydrophilic polymer component is polyethylene oxide. For example, one useful hydrophobic-hydrophilic copolymer component is a polyurethane polymer that includes about 20% hydrophilic polyethylene oxide. The polyethylene oxide portions of the copolymer are thermodynamically driven to separate from the hydrophobic portions of the copolymer and the hydrophobic polymer component. The 20% polyethylene oxide-based soft segment portion of the copolymer used to form the final blend affects the water pick-up and subsequent glucose permeability of the membrane.
In preferred embodiments, the resistance domain is deposited onto the enzyme domain to yield a domain thickness of from about 0.05 microns or less to about 20 microns or more, more preferably from about 0.05, 0.1, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 1, 1.5, 2, 2.5, 3, or 3.5 microns to about 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 19.5 microns, and more preferably still from about 2, 2.5 or 3 microns to about 3.5, 4, 4.5, or 5 microns. Preferably, the resistance domain is deposited onto the enzyme domain by vapor deposition, spray coating, or dip coating. In one preferred embodiment, spray coating is the preferred deposition technique. The spraying process atomizes and mists the solution, and therefore most or all of the solvent is evaporated prior to the coating material settling on the underlying domain, thereby minimizing contact of the solvent with the enzyme.
In another preferred embodiment, physical vapor deposition (e.g., ultrasonic vapor deposition) is used for coating one or more of the membrane domain(s) onto the electrodes, wherein the vapor deposition apparatus and process include an ultrasonic nozzle that produces a mist of micro-droplets in a vacuum chamber. In these embodiments, the micro-droplets move turbulently within the vacuum chamber, isotropically impacting and adhering to the surface of the substrate. Advantageously, vapor deposition as described above can be implemented to provide high production throughput of membrane deposition processes (e.g., at least about 20 to about 200 or more electrodes per chamber), greater consistency of the membrane on each sensor, and increased uniformity of sensor performance, for example, as described below.
In some embodiments, depositing the resistance domain (for example, as described in the preferred embodiments above) includes formation of a membrane system that substantially blocks or resists ascorbate (a known electrochemical interferant in hydrogen peroxide-measuring glucose sensors). While not wishing to be bound by theory, it is believed that during the process of depositing the resistance domain as described in the preferred embodiments, a structural morphology is formed that is characterized in that ascorbate does not substantially permeate therethrough.
In a preferred embodiment, the resistance domain is deposited on the enzyme domain by spray coating a solution of from about 1 wt. % to about 5 wt. % polymer and from about 95 wt. % to about 99 wt. % solvent. In spraying a solution of resistance domain material, including a solvent, onto the enzyme domain, it is desirable to mitigate or substantially reduce any contact with enzyme of any solvent in the spray solution that can deactivate the underlying enzyme of the enzyme domain. Tetrahydrofuran (THF) is one solvent that minimally or negligibly affects the enzyme of the enzyme domain upon spraying. Other solvents can also be suitable for use, as is appreciated by one skilled in the art.
Although a variety of spraying or deposition techniques can be used, spraying the resistance domain material and rotating the sensor at least one time by 180° can typically provide adequate coverage by the resistance domain. Spraying the resistance domain material and rotating the sensor at least two times by 120° provides even greater coverage (one layer of 360° coverage), thereby ensuring resistivity to glucose, such as is described in more detail above.
In preferred embodiments, the resistance domain is spray coated and subsequently cured for a time of from about 15 minutes to about 90 minutes at a temperature of from about 40° C. to about 60° C. (and can be accomplished under vacuum (e.g., from 20 to 30 mmHg)). A cure time of up to about 90 minutes or more can be advantageous to ensure complete drying of the resistance domain.
In one embodiment, the resistance domain is formed by spray coating at least six layers (namely, rotating the sensor seventeen times by 120° for at least six layers of 360° coverage) and curing at 50° C. under vacuum for 60 minutes. However, the resistance domain can be formed by dip coating or spray coating any layer or plurality of layers, depending upon the concentration of the solution, insertion rate, dwell time, withdrawal rate, and/or the desired thickness of the resulting film. Additionally, curing in a convention oven can also be employed.
In certain embodiments, a variable frequency microwave oven can be used to cure the membrane domains/layers. In general, microwave ovens directly excite the rotational mode of solvents. Consequently, microwave ovens cure coatings from the inside out rather than from the outside in as with conventional convection ovens. This direct rotational mode excitation is responsible for the typically observed “fast” curing within a microwave oven. In contrast to conventional microwave ovens, which rely upon a fixed frequency of emission that can cause arcing of dielectric (metallic) substrates if placed within a conventional microwave oven, Variable Frequency Microwave (VFM) ovens emit thousands of frequencies within 100 milliseconds, which substantially eliminates arcing of dielectric substrates. Consequently, the membrane domains/layers can be cured even after deposition on metallic electrodes as described herein. While not wishing to be bound by theory, it is believe that VFM curing can increase the rate and completeness of solvent evaporation from a liquid membrane solution applied to a sensor, as compared to the rate and completeness of solvent evaporation observed for curing in conventional convection ovens.
In certain embodiments, VFM is can be used together with convection oven curing to further accelerate cure time. In some sensor applications wherein the membrane is cured prior to application on the electrode (see, for example, U.S. Publication No. US-2005-0245799-A1, which is incorporated herein by reference in its entirety), conventional microwave ovens (e.g., fixed frequency microwave ovens) can be used to cure the membrane layer.
Treatment of Interference Domain/Membrane System
Although the above-described methods generally include a curing step in formation of the membrane system, including the interference domain, the preferred embodiments further include an additional treatment step, which can be performed directly after the formation of the interference domain and/or some time after the formation of the entire membrane system (or anytime in between). In some embodiments, the additional treatment step is performed during (or in combination with) sterilization of the sensor.
In some embodiments, the membrane system (or interference domain) is treated by exposure to ionizing radiation, for example, electron beam radiation, UV radiation, X-ray radiation, gamma radiation, and the like. Alternatively, the membrane can be exposed to visible light when suitable photoinitiators are incorporated into the interference domain. While not wishing to be bound by theory, it is believed that exposing the interference domain to ionizing radiation substantially crosslinks the interference domain and thereby creates a tighter, less permeable network than an interference domain that has not been exposed to ionizing radiation.
In some embodiments, the membrane system (or interference domain) is crosslinked by forming free radicals, which may include the use of ionizing radiation, thermal initiators, chemical initiators, photoinitiators (e.g., UV and visible light), and the like. Any suitable initiator or any suitable initiator system can be employed, for example, α-hydroxyketone, α-aminoketone, ammonium persulfate (APS), redox systems such as APS/bisulfite, or potassium permanganate. Suitable thermal initiators include but are not limited to potassium persulfate, ammonium persulfate, sodium persulfate, and mixtures thereof.
In embodiments wherein electron beam radiation is used to treat the membrane system (or interference domain), a preferred exposure time is from about 6 k or 12 kGy to about 25 or 50 kGy, more preferably about 25 kGy. However, one skilled in the art appreciates that choice of molecular weight, composition of cellulosic derivative (or other polymer), and/or the thickness of the layer can affect the preferred exposure time of membrane to radiation. Preferably, the exposure is sufficient for substantially crosslinking the interference domain to form free radicals, but does not destroy or significantly break down the membrane or does not significantly damage the underlying electroactive surfaces.
In embodiments wherein UV radiation is employed to treat the membrane, UV rays from about 200 nm to about 400 nm are preferred; however values outside of this range can be employed in certain embodiments, dependent upon the cellulosic derivative and/or other polymer used.
In some embodiments, for example, wherein photoinitiators are employed to crosslink the interference domain, one or more additional domains can be provided adjacent to the interference domain for preventing delamination that may be caused by the crosslinking treatment. These additional domains can be “tie layers” (i.e., film layers that enhance adhesion of the interference domain to other domains of the membrane system). In one exemplary embodiment, a membrane system is formed that includes the following domains: resistance domain, enzyme domain, electrode domain, and cellulosic-based interference domain, wherein the electrode domain is configured to ensure adhesion between the enzyme domain and the interference domain. In embodiments wherein photoinitiators are employed to crosslink the interference domain, UV radiation of greater than about 290 nm is preferred. Additionally, from about 0.01 to about 1 wt % photoinitiator is preferred weight-to-weight with a preselected cellulosic polymer (e.g., cellulose acetate); however values outside of this range can be desirable dependent upon the cellulosic polymer selected.
In general, sterilization of the transcutaneous sensor can be completed after final assembly, utilizing methods such as electron beam radiation, gamma radiation, glutaraldehyde treatment, or the like. The sensor can be sterilized prior to or after packaging. In an alternative embodiment, one or more sensors can be sterilized using variable frequency microwave chamber(s), which can increase the speed and reduce the cost of the sterilization process. In another alternative embodiment, one or more sensors can be sterilized using ethylene oxide (EtO) gas sterilization, for example, by treating with 100% ethylene oxide, which can be used when the sensor electronics are not detachably connected to the sensor and/or when the sensor electronics must undergo a sterilization process. In one embodiment, one or more packaged sets of transcutaneous sensors (e.g., 1, 2, 3, 4, or 5 sensors or more) are sterilized simultaneously.
Signal Response
Advantageously, sensors with the membrane system of the preferred embodiments, including an electrode domain 47 and/or interference domain 48, an enzyme domain 49, and a resistance domain 50, provide stable signal response to increasing glucose levels of from about 40 to about 400 mg/dL, and sustained function (at least 90% signal strength) even at low oxygen levels (for example, at about 0.6 mg/L O2). While not wishing to be bound by theory, it is believed that the resistance domain provides sufficient resistivity, or the enzyme domain provides sufficient enzyme, such that oxygen limitations are seen at a much lower concentration of oxygen as compared to prior art sensors.
In preferred embodiments, a sensor signal with a current in the picoAmp range is preferred, which is described in more detail elsewhere herein. However, the ability to produce a signal with a current in the picoAmp range can be dependent upon a combination of factors, including the electronic circuitry design (e.g., A/D converter, bit resolution, and the like), the membrane system (e.g., permeability of the analyte through the resistance domain, enzyme concentration, and/or electrolyte availability to the electrochemical reaction at the electrodes), and the exposed surface area of the working electrode. For example, the resistance domain can be designed to be more or less restrictive to the analyte depending upon to the design of the electronic circuitry, membrane system, and/or exposed electroactive surface area of the working electrode.
Accordingly, in preferred embodiments, the membrane system is designed with a sensitivity of from about 1 pA/mg/dL to about 100 pA/mg/dL, preferably from about 5 pA/mg/dL to 25 pA/mg/dL, and more preferably from about 3.5 to about 7.5 pA/mg/dL. While not wishing to be bound by any particular theory, it is believed that membrane systems designed with a sensitivity in the preferred ranges permit measurement of the analyte signal in low analyte and/or low oxygen situations. Namely, conventional analyte sensors have shown reduced measurement accuracy in low analyte ranges due to lower availability of the analyte to the sensor and/or have shown increased signal noise in high analyte ranges due to insufficient oxygen necessary to react with the amount of analyte being measured. While not wishing to be bound by theory, it is believed that the membrane systems of the preferred embodiments, in combination with the electronic circuitry design and exposed electrochemical reactive surface area design, support measurement of the analyte in the picoAmp range, which enables an improved level of resolution and accuracy in both low and high analyte ranges not seen in the prior art.
Mutarotase Enzyme
In some embodiments, mutarotase, an enzyme that converts α D-glucose to β D-glucose, is incorporated into the membrane system. Mutarotase can be incorporated into the enzyme domain and/or can be incorporated into another domain of the membrane system. In general, glucose exists in two distinct isomers, α and β, which are in equilibrium with one another in solution and in the blood or interstitial fluid. At equilibrium, α is present at a relative concentration of about 35.5% and β is present in the relative concentration of about 64.5% (see Okuda et. al., Anal Biochem. 1971 September; 43(1):312-5). Glucose oxidase, which is a conventional enzyme used to react with glucose in glucose sensors, reacts with β D-glucose and not with α D-glucose. Since only the β D-glucose isomer reacts with the glucose oxidase, errant readings may occur in a glucose sensor responsive to a shift of the equilibrium between the α D-glucose and the β D-glucose. Many compounds, such as calcium, can affect equilibrium shifts of α D-glucose and β D-glucose. For example, as disclosed in U.S. Pat. No. 3,964,974 to Banaugh et al., compounds that exert a mutarotation accelerating effect on α D-glucose include histidine, aspartic acid, imidazole, glutamic acid, cc hydroxyl pyridine, and phosphate.
Accordingly, a shift in α D-glucose and β D-glucose equilibrium can cause a glucose sensor based on glucose oxidase to err high or low. To overcome the risks associated with errantly high or low sensor readings due to equilibrium shifts, the sensor of the preferred embodiments can be configured to measure total glucose in the host, including α D-glucose and β D-glucose by the incorporation of the mutarotase enzyme, which converts α D-glucose to β D-glucose.
Although sensors of some embodiments described herein include an interference domain in order to block or reduce one or more interferents, sensors with the membrane systems of the preferred embodiments, including an electrode domain 47, an enzyme domain 48, and a resistance domain 49, have been shown to inhibit ascorbate without an additional interference domain. Namely, the membrane system of the preferred embodiments, including an electrode domain 47, an enzyme domain 48, and a resistance domain 49, has been shown to be substantially non-responsive to ascorbate in physiologically acceptable ranges. While not wishing to be bound by theory, it is believed that the processing process of spraying the depositing the resistance domain by spray coating, as described herein, forms results in a structural morphology that is substantially resistance resistant to ascorbate.
Oxygen Conduit
As described above, certain sensors depend upon an enzyme within the membrane system through which the host'"'"'s bodily fluid passes and in which the analyte (for example, glucose) within the bodily fluid reacts in the presence of a co-reactant (for example, oxygen) to generate a product. The product is then measured using electrochemical methods, and thus the output of an electrode system functions as a measure of the analyte. For example, when the sensor is a glucose oxidase based glucose sensor, the species measured at the working electrode is H2O2. An enzyme, glucose oxidase, catalyzes the conversion of oxygen and glucose to hydrogen peroxide and gluconate according to the following reaction:
Glucose+O2→Gluconate+H2O2
Because for each glucose molecule reacted there is a proportional change in the product, H2O2, one can monitor the change in H2O2 to determine glucose concentration. Oxidation of H2O2 by the working electrode is balanced by reduction of ambient oxygen, enzyme generated H2O2 and other reducible species at a counter electrode, for example. See Fraser, D. M., “An Introduction to In Vivo Biosensing: Progress and Problems.” In “Biosensors and the Body,” D. M. Fraser, ed., 1997, pp. 1-56 John Wiley and Sons, New York))
In vivo, glucose concentration is generally about one hundred times or more that of the oxygen concentration. Consequently, oxygen is a limiting reactant in the electrochemical reaction, and when insufficient oxygen is provided to the sensor, the sensor is unable to accurately measure glucose concentration. Thus, depressed sensor function or inaccuracy is believed to be a result of problems in availability of oxygen to the enzyme and/or electroactive surface(s).
Accordingly, in an alternative embodiment, an oxygen conduit (for example, a high oxygen solubility domain formed from silicone or fluorochemicals) is provided that extends from the ex vivo portion of the sensor to the in vivo portion of the sensor to increase oxygen availability to the enzyme. The oxygen conduit can be formed as a part of the coating (insulating) material or can be a separate conduit associated with the assembly of wires that forms the sensor.
Porous Biointerface Materials
In alternative embodiments, the distal portion 42 includes a porous material disposed over some portion thereof, which modifies the host'"'"'s tissue response to the sensor. In some embodiments, the porous material surrounding the sensor advantageously enhances and extends sensor performance and lifetime in the short term by slowing or reducing cellular migration to the sensor and associated degradation that would otherwise be caused by cellular invasion if the sensor were directly exposed to the in vivo environment. Alternatively, the porous material can provide stabilization of the sensor via tissue ingrowth into the porous material in the long term. Suitable porous materials include silicone, polytetrafluoroethylene, expanded polytetrafluoroethylene, polyethylene-co-tetrafluoroethylene, polyolefin, polyester, polycarbonate, biostable polytetrafluoroethylene, homopolymers, copolymers, terpolymers of polyurethanes, polypropylene (PP), polyvinylchloride (PVC), polyvinylidene fluoride (PVDF), polyvinyl alcohol (PVA), polybutylene terephthalate (PBT), polymethylmethacrylate (PMMA), polyether ether ketone (PEEK), polyamides, polyurethanes, cellulosic polymers, polysulfones and block copolymers thereof including, for example, di-block, tri-block, alternating, random and graft copolymers, as well as metals, ceramics, cellulose, hydrogel polymers, poly (2-hydroxyethyl methacrylate, pHEMA), hydroxyethyl methacrylate, (HEMA), polyacrylonitrile-polyvinyl chloride (PAN-PVC), high density polyethylene, acrylic copolymers, nylon, polyvinyl difluoride, polyanhydrides, poly(1-lysine), poly (L-lactic acid), hydroxyethylmethacrylate, hydroxyapeptite, alumina, zirconia, carbon fiber, aluminum, calcium phosphate, titanium, titanium alloy, nintinol, stainless steel, and CoCr alloy, or the like, such as are described in U.S. Publication No. US-2005-0031689-A1 and U.S. Publication No. US-2005-0112169-A1.
In some embodiments, the porous material surrounding the sensor provides unique advantages in the short term (e.g., one to 30 days) that can be used to enhance and extend sensor performance and lifetime. However, such materials can also provide advantages in the long term too (e.g., greater than 30 days). Particularly, the in vivo portion of the sensor (the portion of the sensor that is implanted into the host'"'"'s tissue) is encased (partially or fully) in a porous material. The porous material can be wrapped around the sensor (for example, by wrapping the porous material around the sensor or by inserting the sensor into a section of porous material sized to receive the sensor). Alternately, the porous material can be deposited on the sensor (for example, by electrospinning of a polymer directly thereon). In yet other alternative embodiments, the sensor is inserted into a selected section of porous biomaterial. Other methods for surrounding the in vivo portion of the sensor with a porous material can also be used as is appreciated by one skilled in the art.
The porous material surrounding the sensor advantageously slows or reduces cellular migration to the sensor and associated degradation that would otherwise be caused by cellular invasion if the sensor were directly exposed to the in vivo environment. Namely, the porous material provides a barrier that makes the migration of cells towards the sensor more tortuous and therefore slower (providing short term advantages). It is believed that this reduces or slows the sensitivity loss normally observed in a short-term sensor over time.
In an embodiment wherein the porous material is a high oxygen solubility material, such as porous silicone, the high oxygen solubility porous material surrounds some of or the entire in vivo portion 42 of the sensor. High oxygen solubility materials are materials that dynamically retain a high availability of oxygen that can be used to compensate for the local oxygen deficit during times of transient ischemia (e.g., silicone and fluorocarbons). It is believed that some signal noise normally seen by a conventional sensor can be attributed to an oxygen deficit. In one exemplary embodiment, porous silicone surrounds the sensor and thereby effectively increases the concentration of oxygen local (proximal) to the sensor. Thus, an increase in oxygen availability proximal to the sensor as achieved by this embodiment ensures that an excess of oxygen over glucose is provided to the sensor; thereby reducing the likelihood of oxygen limited reactions therein. Accordingly, by providing a high oxygen solubility material (e.g., porous silicone) surrounding the in vivo portion of the sensor, it is believed that increased oxygen availability, reduced signal noise, longevity, and ultimately enhanced sensor performance can be achieved.
Bioactive Agents
In some alternative embodiments, a bioactive agent is incorporated into the above described porous material and/or membrane system, which diffuses out into the environment adjacent to the sensing region, such as is described in U.S. Publication No. US-2005-0031689-A1. Additionally or alternately, a bioactive agent can be administered locally at the exit-site or implantation-site. Suitable bioactive agents are those that modify the host'"'"'s tissue response to the sensor, for example anti-inflammatory agents, anti-infective agents, anesthetics, inflammatory agents, growth factors, immunosuppressive agents, antiplatelet agents, anti-coagulants, anti-proliferates, ACE inhibitors, cytotoxic agents, anti-barrier cell compounds, vascularization-inducing compounds, anti-sense molecules, or mixtures thereof, such as are described in more detail in co-pending U.S. Patent Publication No. US-2005-0031689-A1.
In embodiments wherein the porous material is designed to enhance short-term (e.g., from about 1 to about 30 days) lifetime or performance of the sensor, a suitable bioactive agent can be chosen to ensure that tissue ingrowth does not substantially occur within the pores of the porous material. Namely, by providing a tissue modifying bioactive agent, such as an anti-inflammatory agent (for example, Dexamethasone), substantially tissue ingrowth can be inhibited, at least in the short term, in order to maintain sufficient glucose transport through the pores of the porous material to maintain a stable sensitivity.
In embodiments wherein the porous material is designed to enhance long-term (e.g., from about a day to about a year or more) lifetime or performance of the sensor, a suitable bioactive agent, such as a vascularization-inducing compound or anti-barrier cell compound, can be chosen to encourage tissue ingrowth without barrier cell formation.
In some alternative embodiments, the in vivo portion of the sensor is designed with porosity therethrough, for example, a design wherein the sensor wires are configured in a mesh, loose helix configuration (namely, with spaces between the wires), or with micro-fabricated holes therethrough. Porosity within the sensor modifies the host'"'"'s tissue response to the sensor, because tissue ingrowth into and/or through the in vivo portion of the sensor increases stability of the sensor and/or improves host acceptance of the sensor, thereby extending the lifetime of the sensor in vivo.
Sensor Manufacture
In some embodiments, the sensor is manufactured partially or wholly using a continuous reel-to-reel process, wherein one or more manufacturing steps are automated. In such embodiments, a manufacturing process can be provided substantially without the need for manual mounting and fixing steps and substantially without the need human interaction. A process can be utilized wherein a plurality of sensors of the preferred embodiments, including the electrodes, insulator, and membrane system, are continuously manufactured in a semi-automated or automated process.
In one embodiment, a plurality of twisted pairs is continuously formed into a coil, wherein a working electrode is coated with an insulator material around which a plurality of reference electrodes is wound. The plurality of twisted pairs are preferably indexed and subsequently moved from one station to the next whereby the membrane system is serially deposited according to the preferred embodiments. Preferably, the coil is continuous and remains as such during the entire sensor fabrication process, including winding of the electrodes, insulator application, and membrane coating processes. After drying of the membrane system, each individual sensor is cut from the continuous coil.
A continuous reel-to-reel process for manufacturing the sensor eliminates possible sensor damage due to handling by eliminating handling steps, and provides faster manufacturing due to faster trouble shooting by isolation when a product fails. Additionally, a process run can be facilitated because of elimination of steps that would otherwise be required (e.g., steps in a manual manufacturing process). Finally, increased or improved product consistency due to consistent processes within a controlled environment can be achieved in a machine or robot driven operation.
In certain embodiments, vapor deposition (e.g., physical vapor deposition) is utilized to deposit one or more of the membrane domains onto the sensor. Vapor deposition can be used to coat one or more insulating layers onto the electrodes and one or more of the domains of the membrane system onto the electrochemically reactive surfaces. The vapor deposition process can be a part of a continuous manufacturing process, for example, a semi-automated or fully-automated manufacturing process. Physical vapor deposition processes are generally preferred. In such physical vapor deposition processes in the gas phase for forming a thin film, source material is physically transferred in a vacuum to the substrate without any chemical reaction(s) involved. Physical vapor deposition processes include evaporation (e.g., by thermal or e-beam) and sputtering processes. In alternative embodiments, chemical vapor deposition can be used. In chemical vapor deposition processes for depositing a thin film, the substrate is exposed to one or more volatile precursors, which react and/or decompose on the substrate surface to produce the desired deposit. Advantageously, vapor deposition processes can be implemented to provide high production throughput of membrane deposition processes (e.g., deposition on at least about 20 to about 200 or more electrodes per chamber), greater consistency of the membrane on each senso