Transcutaneous analyte sensor

• US 9,801,572 B2
• Filed: 06/18/2015
• Issued: 10/31/2017
• Est. Priority Date: 07/13/2004
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brister, Mark C., Neale, Paul V., Brauker, James H.
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US14/743,777
• Publication Number:
  US 20150282741A1
• Time in Patent Office: 866 Days
• Field of Search: 600309, 600345-366
• 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 system for measuring an analyte in a host, comprising:

a sensor electronics housing;

an on-skin assembly configured to releasably attach with the sensor electronics housing; and

a sensor comprising at least one electrode, the sensor comprising;

an in vivo portion adapted for insertion through an exit port of the sensor electronics housing and through an exit site of the host'"'"'s skin; and

an ex vivo portion adapted to remain above the host'"'"'s skin after sensor insertion and to operably connect to the sensor electronics housing, wherein the ex vivo portion is configured to be bent by attachment of the sensor electronics housing to the on-skin assembly.

2. The system of claim 1, wherein the ex vivo portion is configured to be bent relative to the in vivo portion following attachment of the sensor electronics housing to the on-skin assembly.

3. The system of claim 1, wherein the on skin assembly is adapted for placement over an exit site of the host'"'"'s skin.

4. The system of claim 1, wherein the exit port is at a location substantially closer to the center than edges of the on skin assembly.

5. The system of claim 1, wherein the exit port comprises a layer of sealing material to reduce or eliminate the migration of bacteria or other contaminants between the exit-site and the housing.

6. The system of claim 4, wherein the layer of sealing material comprises a septum seal.

7. The system of claim 4, wherein the layer of sealing material comprises a silicone seal.

8. The system of claim 1, further comprising an applicator configured to insert the sensor through the exit port and the exit site.

9. The system of claim 1, wherein the sensor comprises a plurality of electrodes.

10. The system of claim 1, wherein the sensor electronics comprise a data sampling portion in data communication with the at least one electrode, wherein the data sampling portion comprises an analog portion configured to measure the current flowing at the at least one electrode and to convert the current measurement to digital values representative of the current, wherein the digital values are acquired at a predetermined time interval.

11. The system of claim 10, wherein the predetermined time interval is adaptively determined based on another parameter of the system.

12. The system of claim 10, wherein the sensor electronics comprise an integrated circuit comprising the data sampling portion.

13. The system of claim 1, wherein the sensor electronics comprise a transmitter portion for transmitting a signal indicating a level of the analyte in the host at a programmable transmission interval.

14. The system of claim 13, wherein the programmable transmission interval is adaptively determined based on another parameter of the system.

15. The system of claim 13, wherein the sensor electronics comprise an integrated circuit comprising the transmitter portion.

16. A system for measuring an analyte in a host, comprising:

a sensor electronics housing;

an on-skin assembly configured to releasably attach with the sensor electronics housing;

a sensor comprising at least one electrode, the sensor comprising;

an in vivo portion adapted for insertion through an exit port of the sensor electronics housing and through an exit site of the host'"'"'s skin; and

an ex vivo portion adapted to remain above the host'"'"'s skin after sensor insertion and to operably connect to the sensor electronics housing, wherein the ex vivo portion is configured to be bent by attachment of the sensor electronics housing to the on-skin assembly; and

an inserter configured to insert the sensor into the host, wherein the inserter is configured to be removed from the on-skin assembly prior to attachment of the electronics housing.

17. The system of claim 16, wherein the ex vivo portion is configured to be bent after sensor insertion.

18. The system of claim 16, wherein the ex vivo portion is configured to be bent relative to the in vivo portion following attachment of the sensor electronics housing to the on-skin assembly.

19. The system of claim 16, wherein the on skin assembly is adapted for placement over an exit site of the host'"'"'s skin.

20. The system of claim 16, wherein the inserter is configured to insert the sensor through the exit port and the exit site.