Implantable analyte sensor

• US 6,405,066 B1
• Filed: 03/17/2000
• Issued: 06/11/2002
• Est. Priority Date: 03/17/2000
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Corporation (Roche Holding AG), Regents of the University of California (University of California)
• Inventors: Desai, Tejal A., Hansford, Derek J., Ferrari, Mauro, Essenpreis, Matthias
• Primary Examiner(s): Shaver, Kevin
• Assistant Examiner(s): Natnithithadha, Navin
• Application Number:
  US09/528,277
• Time in Patent Office: 816 Days
• Field of Search: 600/309, 600/316, 600/319, 600/345, 600/347, 600/365, 600/372, 600/373, 600/377, 204/403, 204/400, 204/415, 204/411, 204/412, 204/401
• US Class Current: 600/347
• 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: C12Q 1/006 for glucose

Abstract

An implantable analyte sensor includes a substrate, electrodes on the substrate, and a membrane on the electrodes. The membrane can comprise elemental silicon and has a glucose diffusion test result of at least 1 mg/dl in 330 min., and an albumin diffusion test result of at most 0.1 g/dl in 420 min.

Claims

1. An implantable analyte sensor, comprising:

(a) a substrate,

(b) electrodes on said substrate, and

(c) a membrane on said electrodes,

wherein said membrane comprises elemental silicon and has a glucose diffusion test result of at least 1 mg/dl in 330 min., and an albumin diffusion test result of at most 0.1 g/dl in 420 min.

2. The implantable analyte sensor of claim 1, further comprising:

(d) microelectronic circuitry electrically connected to said electrodes.

3. The implantable analyte sensor of claim 1, further comprising:

(e) leads electrically connected to said electrodes.

4. The implantable analyte sensor of claim 2, further comprising:

(e) leads electrically connected to said electrodes,

wherein said leads are electrically connected to said electrodes via said microelectronic circuitry.

5. The implantable analyte sensor of claim 2, wherein said microelectronic circuitry comprises a transmitter and a power supply.

6. The implantable analyte sensor of claim 1, further comprising:

(f) a coating surrounding said substrate and said membrane.

7. The implantable analyte sensor of claim 6, wherein said coating comprises an internal coating and an external coating.

8. The implantable analyte sensor of claim 1, wherein said substrate comprises elemental silicon.

9. The implantable analyte sensor of claim 1, wherein said membrane is prepared by micromachining.

10. The implantable analyte sensor of claim 1, wherein said glucose diffusion test result is at least 60 mg/dl in 330 min., and said albumin diffusion test result is at most 0.001 g/dl in 420 min.

11. The implantable analyte sensor of claim 1, wherein the implantable analyte sensor is a glucose sensor.

12. An implantable analyte sensor, comprising:

(a) a substrate,

(b) electrodes on said substrate, and

(c) a membrane on said electrodes,

wherein said membrane has a glucose diffusion test result of at least 1 mg/dl in 330 min., and an albumin diffusion test result of at most 0.1 g/dl in 420 min.

13. The implantable analyte sensor of claim 12, wherein said glucose diffusion test result is at least 60 mg/dl in 330 min., and said albumin diffusion test result is at most 0.001 g/dl in 420 min.

14. The implantable analyte sensor of claim 12, further comprising:

(d) microelectronic circuitry electrically connected to said electrodes.

15. The implantable analyte sensor of claim 12, further comprising:

(e) leads electrically connected to said electrodes.

16. The implantable analyte sensor of claim 14, further comprising:

(e) leads electrically connected to said electrodes,

wherein said leads are electrically connected to said electrodes via said microelectronic circuitry.

17. The implantable analyte sensor of claim 14, wherein said microelectronic circuitry comprises a transmitter and a power supply.

18. The implantable analyte sensor of claim 12, further comprising:

(f) a coating surrounding said substrate and said membrane.

19. The implantable analyte sensor of claim 18, wherein said coating comprises an internal coating and an external coating.

20. The implantable analyte sensor of claim 12, wherein said substrate comprises elemental silicon.

21. The implantable analyte sensor of claim 12, wherein said membrane is prepared by micromachining.

22. The implantable analyte sensor of claim 12, wherein the implantable analyte sensor is a glucose sensor.

23. A method of making an implantable analyte sensor, comprising:

covering electrodes with a membrane;

wherein said electrodes are on a substrate and said membrane comprises elemental silicon and has a glucose diffusion test result of at least 1 mg/dl in 330 min., and an albumin diffusion test result of at most 0.1 g/dl in 420 min.

24. The method of claim 23, further comprising:

forming said membrane by micromachining elemental silicon.

25. The method of claim 23, further comprising:

surrounding said membrane and said substrate with a coating.

26. The method of claim 23, wherein said glucose diffusion test result is at least 60 mg/dl in 330 min., and said albumin diffusion test result is at most 0.001 g/dl in 420 min.

27. The method of claim 23, wherein the implantable analyte sensor is a glucose sensor.

28. A method of making an implantable analyte sensor, comprising:

covering electrodes with a membrane,

wherein said electrodes are on a substrate, and

said membrane has a glucose diffusion test result of at least 1 mg/dl in 330 min., and an albumin diffusion test result of at most 0.1 g/dl in 420 min.

29. The method of claim 28, further comprising:

forming said membrane by micromachining elemental silicon.

30. The method of claim 28, further comprising:

surrounding said membrane and said substrate with a coating.

31. The method of claim 28, wherein said glucose diffusion test result is at least 60 mg/dl in 330 min., and said albumin diffusion test result is at most 0.001 g/dl in 420 min.

32. The method of claim 28, wherein said membrane is prepared by micromachining.

33. The method of claim 28, wherein the implantable analyte sensor is a glucose sensor.

34. In an implantable analyte sensor including electrodes on a substrate and a membrane covering the electrodes, the improvement comprising the membrane having a glucose diffusion test result of at least 1 mg/dl in 330 min., and an albumin diffusion test result of at most 0.1 g/dl in 420 min.

35. An implantable analyte sensor, comprising:

(i) means for measuring an analyte electrochemically, and

(ii) a membrane on said means,

wherein said membrane has a glucose diffusion test result of at least 1 mg/dl in 330 min., and an albumin diffusion test result of at most 0.1 g/dl in 420 min.