Analyte sensor

• US 20060270922A1
• Filed: 05/23/2006
• Published: 11/30/2006
• Est. Priority Date: 07/13/2004
• Status: Abandoned Application

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Boock, Robert, Brister, Mark, Brauker, James H., Simpson, Peter C., Rixman, Monica
• Application Number:
  US11/439,559
• Publication Number:
  US 20060270922A1
• 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. A wholly implantable sensing device, the device comprising:

a sensor configured for implantation into a host and configured to detect an analyte in the host, wherein the sensor has an architecture with at least one dimension less than about 1 mm;

a porous biointerface covering at least a portion of the sensor; and

electronics operatively coupled to the sensor.

2. The device of claim 1, wherein the electronics are operatively connected to the sensor within a body of the sensor.

3. The device of claim 1, further comprising a tether configured for operatively connecting the sensor to the electronics.

4. The device of claim 1, wherein the electronics are inductively coupled to the sensor.

5. The device of claim 1, further comprising a mechanical spacer around the sensor or a protective framework around the sensor.

6. The device of claim 1, wherein the electronics are configured to detect a signal from the sensor and wherein the signal is indicative of at least one of a presence and a concentration of the analyte within the biointerface.

7. The device of claim 1, wherein the biointerface is an electrospun biointerface.

8. The device of claim 1, wherein the biointerface is formed directly on the sensor.

9. The device of claim 1, wherein the biointerface is preformed and subsequently applied to the sensor.

10. The device of claim 1, wherein the biointerface comprises a material selected from the group consisting of silicone, polytetrafluoroethylene, expanded polytetrafluoroethylene, polyethylene-co-tetrafluoroethylene, polyolefin, polyester, polycarbonate, biostable polytetrafluoroethylene, polyurethane homopolymer, polyurethane copolymer, polyurethane terpolymer, polypropylene, polyvinylchloride, polyvinylidene fluoride, polyvinyl alcohol, polybutylene terephthalate, polymethylmethacrylate, polyether ether ketone, polyamide, polyurethane, cellulosic polymer, poly(ethylene oxide), poly(propylene oxide), poly(propylene oxide) copolymer, polysulfone, polysulfone, block copolymers thereof, di-block copolymers thereof, tri-block copolymers thereof, alternating copolymers thereof, random copolymers thereof, graft copolymers thereof, mixtures thereof, and blends thereof.

11. The device of claim 1, wherein the biointerface is a fibrous biointerface.

12. The device of claim 11, wherein the biointerface comprises fibers less than about 6 microns in all but the longest dimension.

13. The device of claim 11, wherein passageways in the biointerface are configured to allow passage therein of invasive cells and to not allow extensive ingrowth of vascular tissue therein.

14. The device of claim 1, wherein the biointerface is an amorphous biointerface.

15. The device of claim 1, wherein a majority of pores of the biointerface are greater than about 0.6 microns in at least one dimension.

16. The device of claim 1, wherein the porous biointerface is configured to support tissue ingrowth.

17. The device of claim 1, wherein the biointerface is configured to resist barrier cell layer formation.

18. The device of claim 1, wherein the porous biointerface comprises interconnected pores.

19. The device of claim 1, wherein the biointerface further comprises a bioactive agent.

20. The device of claim 19, 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.

21. The device of claim 1, wherein the sensor comprises a working electrode embedded within the biointerface.

22. The device of claim 1, wherein the sensor further comprises at least one of a reference electrode embedded within the biointerface or deposited on a surface of the biointerface and a counter electrode embedded within the biointerface or deposited on a surface of the biointerface.

23. A wholly implantable device for measuring an analyte in a host, the device comprising a sensor configured for insertion into the host, wherein the sensor has an architecture with at least one dimension less than about 1 mm, a porous biointerface comprising a solid portion and a plurality of passageways extending from openings in an exterior surface of the biointerface into an interior portion of the biointerface, and electronics operatively coupled to the sensor.

24. The device of claim 23, wherein the passageways are interconnected.

25. The device of claim 23, wherein a cavity size of the passageways is greater than about 0.6 microns in at least one dimension.

26. The device of claim 23, wherein the biointerface is configured to resist barrier cell layer formation.

27. The device of claim 23, wherein the biointerface is configured to have a depth of greater than one passageway in three dimensions substantially throughout the entirety of a matrix comprising the biointerface.

28. The device of claim 23 wherein the solid portion comprises fibers.

29. The device of claim 23, wherein the solid portion comprises fibers less than about 6 microns in all but the longest dimension.

30. The device of claim 23, wherein the passageways are configured to allow passage of invasive cells therein and to not allow extensive ingrowth of vascular tissue therein.

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

wholly implanting an analyte sensing device within a host, the device comprising a sensor for measuring the analyte in the host, wherein the sensor has an architecture with at least one dimension less than about 1 mm, a porous biointerface covering at least a portion of the sensor, and an electronics unit operatively coupled to the sensor;

allowing tissue ingrowth within the biointerface; and

detecting from the sensor a signal indicative of at least one of a presence and a concentration of the analyte in the host.

32. The method of claim 31, wherein the sensor is tethered to the electronics unit.

33. The method of claim 31, wherein the sensor is inductively coupled to the electronics unit.

34. The method of claim 31, wherein the signal is indicative of a presence of the analyte in the host or a concentration of analyte in the host.

35. The method of claim 31, wherein the biointerface is configured to prevent formation of a barrier-cell layer.

36. The method of claim 31, further comprising removing the sensor from the host after at least about 1 month.