TRANSCUTANEOUS ANALYTE SENSOR

• US 20120277562A1
• Filed: 07/12/2012
• Published: 11/01/2012
• Est. Priority Date: 07/13/2004
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brister, Mark, Neale, Paul V., Saint, Sean, Petisce, James R., McGee, Thomas F., Codd, Daniel Shawn, Petersen, David Michael, Kline, Daniel S.
• Granted Patent: US 9,833,176 B2
• Time in Patent Office: Days
• US Class Current: 600/347
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/3492 against the outside of the body
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 2562/18 Shielding or protection of sensors from environmental influences, e.g. protection from mechanical damage
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/14 Devices for taking samples of blood hypodermic syringes A61M5/00; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood measuring of blood pressure A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/1473 : invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/14735 : comprising an immobilised reagent
• CPC Class Codes: A61B 5/1486 : using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/14865 : invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/1495 : Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/150022 : for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/6801 : specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: A61B 5/68335 : including release sheets or liners
• CPC Class Codes: A61B 5/6848 : Needles
• CPC Class Codes: A61B 5/6849 : in combination with a needle set
• CPC Class Codes: A61B 5/72 : Signal processing specially adapted for physiological signals or for diagnostic purposes character recognition, recognising digital ink, document-oriented image-based pattern recognition G06V30/00; recognition or understanding of postal images G06V30/424
• CPC Class Codes: A61M 2005/1585 : Needle inserters
• CPC Class Codes: A61M 5/14244 : adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

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.

Claims

1. A transcutaneous system for measuring an analyte concentration in a host, the system comprising:

a sensor adapted for transcutaneous placement through a skin of a host, the sensor comprising a first end and a second end;

a housing configured to support the sensor during a period of transcutaneous insertion; and

an applicator comprising a needle configured for inserting the sensor into the skin of the host;

wherein the needle is capable of inserting the first end of sensor into the host, sliding back over the second end of the sensor, and wherein the needle is configured to be released from the housing during the period of continuous transcutaneous insertion, wherein the first end and second end of the sensor are sized to fully reside within the needle.

2. The system of claim 1, further comprising sensor electronics configured to releasably attach to the housing during the period of transcutaneous insertion.

3. The system of claim 1, wherein the time period of transcutaneous insertion is at least about 3 days.

4. A transcutaneous system for measuring an analyte concentration in a host, the system comprising:

a non-planar sensor adapted for transcutaneous placement through a skin of a host, the sensor comprising a first end and a second end; and

an applicator comprising a needle configured for inserting the sensor into the skin of the host, wherein the system is configured such that the needle is capable of inserting the first end of sensor into the host, sliding back over the second end of the sensor, and thereby releasing the sensor from the needle, wherein a portion of the second end of the sensor is configured to provide connectivity between the sensor and sensor electronics.

5. The system of claim 4, wherein the non-planar sensor comprises a working electrode formed from a wire.

6. The system of claim 5, wherein the wire has a diameter of less than about 0.010 inches.

7. A transcutaneous system for measuring an analyte concentration in a host, the system comprising:

a sensor adapted for transcutaneous placement through a skin of a host, the sensor comprising a first electrode formed from a wire, an insulator that fully surrounds at least a portion of the wire and a second electrode that fully surrounds at least a portion of the insulator; and

an applicator comprising a needle configured for inserting the sensor into the skin of the host;

wherein the system is configured such that the needle is capable of inserting at least the first electrode of the sensor into the host, sliding back over the first electrode and the second electrode of the sensor, and thereby releasing the sensor from the needle, wherein a portion of the second end has a first electrode connection comprising an exposed electroactive surface of the wire and a second electrode connection on an exposed electroactive surface of the second electrode.

8. The system of claim 7, wherein the wire has a diameter of less than about 0.010 inches.

9. The system of claim 7, wherein the wire has a diameter of less than about 0.005 inches.

10. A transcutaneous system for measuring an analyte concentration in a host, the system comprising:

a sensor adapted for transcutaneous placement through a skin of a host, the sensor comprising a first end and a second end; and

an applicator comprising a needle configured for inserting the sensor into the skin of the host;

wherein the system is configured such that the needle is capable of inserting the first end of sensor into the host, sliding back over the second end of the sensor, and releasing the sensor from the needle, wherein a portion of the second end comprises a first electrode connection and a second electrode connection, and wherein the first electrode connection and the second electrode connection are longitudinally separated along a longitudinal axis of the sensor.

11. The system of claim 10, wherein the non-planar sensor is formed from a wire.

12. The system of claim 10, wherein the non-planar sensor comprises a circular cross-section.