Analyte sensor

• US 20060270923A1
• Filed: 05/23/2006
• Published: 11/30/2006
• Est. Priority Date: 07/13/2004
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Boock, Robert, Brister, Mark, Brauker, James H., Simpson, Peter C., Rixman, Monica
• Granted Patent: US 10,022,078 B2
• Time in Patent Office: Days
• US Class Current: 600/345
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/418 lymph vessels, ducts or nodes
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The present invention relates generally to biointerface membranes utilized with implantable devices, such as devices for the detection of analyte concentrations in a biological sample. More particularly, the invention relates to novel biointerface membranes, to devices and implantable devices including these membranes, methods for forming the biointerface membranes on or around the implantable devices, and to methods for monitoring glucose levels in a biological fluid sample using an implantable analyte detection device.

Claims

1. An analyte sensing device adapted for short term insertion into a host'"'"'s soft tissue, comprising:

a sensor having an architecture with at least one dimension less than about 1 mm, wherein the architecture is configured to create a fluid-filled pocket surrounding at least a portion of the sensor in vivo.

2. The device of claim 1, wherein the sensor is configured to measure a signal that is indicative of a concentration of the analyte within the fluid-filled pocket.

3. The device of claim 1, further comprising electronics operatively coupled to the sensor and configured for detecting a signal from the sensor, wherein the signal is indicative of a concentration of an analyte within the host.

4. The device of claim 3, further comprising a housing configured for placement adjacent to a host'"'"'s skin, wherein at least a portion of the electronics are disposed in the housing.

5. The device of claim 1, wherein the sensor is a transcutaneous sensor.

6. The device of claim 1, further comprising a spacer covering at least a portion of the sensor.

7. The device of claim 6, wherein the spacer covers a sensing mechanism of the sensor.

8. The device of claim 6, wherein the spacer comprises a biointerface.

9. The device of claim 6, wherein the spacer comprises a porous membrane configured to allow a body fluid to fill pores to thereby form a fluid-filled pocket.

10. The device of claim 1, further comprising a bioactive agent incorporated into the sensor.

11. The device of claim 10, wherein the bioactive agent is selected from the group consisting of an anti-barrier cell agent, an anti-inflammatory agent, an anti-infective agent, a necrosing agent, an anesthetic, an inflammatory agent, a growth factor, an angiogenic factor, an adjuvant, an immunosuppressive agent, an antiplatelet agent, an anticoagulant, an ACE inhibitor, a cytotoxic agent, a vascularization compound, and an anti-sense molecule.

12. An analyte sensor for measuring an analyte in a host, the sensor comprising:

a sensor configured for transcutaneous insertion into a host'"'"'s skin, wherein the sensor has an architecture with at least one dimension less than about 1 mm; and

a biointerface covering at least a portion of the sensor.

13. The device of claim 12, wherein the biointerface is configured to allow fluid influx.

14. The device of claim 12, wherein the sensor is a transcutaneous sensor.

15. The device of claim 12, further comprising electronics operatively coupled to the sensor and configured for detecting a signal from the sensor.

16. The device of claim 15, wherein the electronics are inductively coupled to the sensor.

17. The device of claim 12, further comprising a housing configured for placement adjacent to the host'"'"'s skin.

18. The device of claim 12, further comprising a bioactive agent incorporated into the sensor.

19. The device of claim 18, wherein the bioactive agent is selected from the group consisting of an anti-barrier cell agent, an anti-inflammatory agent, an anti-infective agent, a necrosing agent, an anesthetic, an inflammatory agent, a growth factor, an angiogenic factor, an adjuvant, an immunosuppressive agent, an antiplatelet agent, an anticoagulant, an ACE inhibitor, a cytotoxic agent, a vascularization compound, and an anti-sense molecule.

20. The device of claim 12, wherein the biointerface is configured to provide a space for a body fluid to reside around the sensor in vivo.

21. The device of claim 12, wherein the biointerface is a porous membrane.

22. The device of claim 12, wherein the biointerface covers at least a sensing mechanism of the sensor.

23. A method of detecting an analyte in a host, comprising:

a) inserting a sensor through a host'"'"'s skin and into the host, wherein the sensor is a component of an analyte sensing device configured for transcutaneous insertion into the host, wherein the sensor has an architecture with at least one dimension less than about 1 mm, and wherein a biointerface covers at least a portion of the sensor, whereby fluid flows into the biointerface upon insertion of the sensor into the host;

b) detecting from the sensor a signal indicative of a presence or a concentration of the analyte in the host; and

c) removing the sensor from the host.

24. The method of claim 23, further comprising repeating steps a) through c) within about 3 days or less.

25. The method of claim 23, further comprising repeating steps a) through c) within about 5 days or less.

26. The method of claim 23, further comprising repeating steps a) through c) within about 7 days or less.

27. The method of claim 23, further comprising repeating steps a) through c) within about 10 days or less.

28. The method of claim 23, further comprising repeating steps a) through c) after about 3 days.

29. The method of claim 23, further comprising repeating steps a) through c) after about 5 days.

30. The method of claim 23, further comprising repeating steps a) through c) after about 7 days.

31. The method of claim 23, further comprising repeating steps a) through c) after about 10 days.

32. The method of claim 23, further comprising coupling an electronics unit to the sensor.

33. The method of claim 23, wherein the sensor is a transcutaneous sensor.

34. The method of claim 23, further comprising inductively coupling an electronics unit to the sensor.