Implantable sensor

• US 7,033,322 B2
• Filed: 11/08/2001
• Issued: 04/25/2006
• Est. Priority Date: 05/15/2000
• Status: Expired due to Term

• Current Assignee: James H. Silver
• Original Assignee: James H. Silver
• Inventors: Silver, James H.
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US10/041,036
• Publication Number:
  US 20020128546A1
• Time in Patent Office: 1,629 Days
• Field of Search: 600/549, 600/561, 600/486, 600/488, 600/505, 600345-350, 600/365
• US Class Current: 600/486
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 5/6862 Stents
• CPC Class Codes: A61B 5/6876 Blood vessel

Abstract

A sensor is disclosed, for implantation within a blood vessel to monitor an analyte in blood. In one embodiment, the analyte is glucose. A signal indicative of glucose level is transmitted to an external receiver. The signal may also be used to drive an internal or externally worn insulin pump. Methods are also disclosed.

Claims

1. An implantable sensor for sensing the presence of an analyte in a vessel, comprising:

at least two substantially tubular support structures directly connected to one another, for anchoring the sensor in the vessel, each support structure having a side wall with a luminal side facing toward the center of the vessel and an abluminal side facing toward the wall of the vessel;

a sensor housing carried by the support structures, the housing having a streamlined exterior configuration to minimize blood flow turbulence and located between two support structures;

a power supply and electrical circuitry in the housing; and

a sensing surface exposed to the exterior of the housing;

wherein the sensing surface is positioned on the radially inwardly most portion of the luminal side of the housing.

2. An implantable sensor as in claim 1, wherein the sensor housing is positioned on the luminal side of the support structures.

3. An implantable sensor as in claim 1, further comprising tubular sleeves surrounding the tubular support structures.

4. An implantable sensor as in claim 3, wherein the tubular sleeves are on the abluminal surface of the tubular support structures.

5. An implantable sensor as in claim 3, wherein the tubular sleeves are on the luminal surface of the tubular support structures.

6. An implantable sensor as in claim 3, wherein the tubular sleeves comprise ePTFE.

7. An implantable sensor as in claim 1, further comprising an analyte permeable membrane and an enzyme gel layer.

8. An implantable sensor as in claim 7, wherein the enzyme gel layer comprises glucose oxidase.

9. An implantable sensor as in claim 1, wherein the sensor comprises an amperometric sensor.

10. An implantable sensor as in claim 1, wherein the sensor comprises an electrode selected from the group consisting of oxygen electrodes, hydrogen peroxide electrodes, and electrodes with mediated electron transfer.

11. An implantable sensor as in claim 1, wherein the sensing surface is spaced radially inwardly from the luminal side by a distance of at least about 0.2 mm, such that the velocity of blood in the vessel inhibits obstruction of the sensing surface.

12. An implantable sensor as in claim 11, wherein the distance is at least about 0.5 mm.

13. An implantable sensor as in claim 11, wherein the distance is within the range of from about 0.3 mm to about 2.5 mm.

14. An implantable sensor as in claim 11, wherein the distance is sufficient to increase the blood flow velocity at the sensing surface to from about 125% to about 200% of the blood flow velocity immediately proximal to the support structures.

15. An implantable sensor as in claim 11, further comprising a transmitter mounted to at least one of the support structures, for transmitting information from the sensor to an external receiver.

16. An implantable sensor as in claim 15, wherein an inductive link supplies power to the transmitter.

17. An implantable sensor as in claim 11, further comprising a thin film rechargeable battery carried by the support structures.

18. An implantable sensor as in claim 11, wherein the support structures comprise enlargeable frames.

19. An implantable sensor as in claim 18, wherein the support structures comprise expandable tubular bodies.

20. An implantable sensor as in claim 11, wherein the support structures comprise balloon expandable stents.

21. An implantable sensor as in claim 11, wherein the support structures comprise self expandable stents.

22. An implantable sensor for sensing the presence of an analyte in a vessel, comprising:

at least two substantially tubular support structures for anchoring the sensor in the vessel, each support structure having a side wall with a luminal side facing toward the center of the vessel and an abluminal side facing toward the wall of the vessel;

a sensor housing carried by the support structures, the housing having a streamlined exterior configuration to minimize blood flow turbulence and located between the two support structures and positioned on the luminal side of the support structures;

a power supply and electrical circuitry in the housing; and

a sensing surface exposed to the exterior of the housing;

wherein the sensing surface is positioned radially inwardly from the tubular support structures.

23. An implantable sensor as in claim 22, wherein the support structures are directly connected to one another.

24. An implantable sensor as in claim 22, wherein the support structures are not directly connected to one another.

25. An implantable sensor as in claim 22, further comprising a tubular sleeves surrounding the tubular support structures.

26. An implantable sensor as in claim 25, wherein the tubular sleeves are on the abluminal surface of the tubular support structures.

27. An implantable sensor as in claim 25, wherein the tubular sleeve is on the luminal surface of the tubular support structures.

28. An implantable sensor as in claim 25, wherein the tubular sleeves comprise ePTFE.

29. An implantable sensor as in claim 22, further comprising an analyte permeable membrane and an enzyme gel layer.

30. An implantable sensor as in claim 29, wherein the enzyme gel layer comprises glucose oxidase.

31. An implantable sensor as in claim 22, wherein the sensor comprises an amperometric sensor.

32. An implantable sensor as in claim 22, wherein the sensor comprises an electrode selected from the group consisting of oxygen electrodes, hydrogen peroxide electrodes, and electrodes with mediated electron transfer.

33. An implantable sensor for sensing the presence of an analyte in a vessel, comprising:

at least two substantially tubular support structures for anchoring the sensor in the vessel, each support structure having a side wall with a luminal side facing toward the center of the vessel and an abluminal side facing toward the wall of the vessel;

tubular sleeves surrounding the tubular support structures;

a sensor housing carried by the support structures, the housing having a streamlined exterior configuration to minimize blood flow turbulence and located between two support structures;

a power supply and electrical circuitry in the housing; and

a sensing surface exposed to the exterior of the housing;

wherein the sensing surface is positioned radially inwardly from the tubular support structures.

34. An implantable sensor as in claim 33, wherein the support structures are directly connected to one another.

35. An implantable sensor as in claim 33, wherein the support structures are not directly connected to one another.

36. An implantable sensor as in claim 33, wherein the sensor housing is positioned on the luminal side of the support structures.

37. An implantable sensor as in claim 33, wherein the tubular sleeves are on the abluminal surface of the tubular support structures.

38. An implantable sensor as in claim 33, wherein the tubular sleeves are on the luminal surface of the tubular support structures.

39. An implantable sensor as in claim 33, wherein the tubular sleeves comprise ePTFE.

40. An implantable sensor as in claim 33, further comprising an analyte permeable membrane and an enzyme gel layer.

41. An implantable sensor as in claim 40, wherein the enzyme gel layer comprises glucose oxidase.

42. An implantable sensor as in claim 33, wherein the sensor comprises an amperometric sensor.

43. An implantable sensor as in claim 33, wherein the sensor comprises an electrode selected from the group consisting of oxygen electrodes, hydrogen peroxide electrodes, and electrodes with mediated electron transfer.

44. An implantable sensor as in claim 33, wherein the sensing surface is spaced radially inwardly from the luminal side by a distance of at least about 0.2 mm, such that the velocity of blood in the vessel inhibits obstruction of the sensing surface.

45. An implantable sensor as in claim 33, wherein the distance is at least about 0.5 mm.

46. An implantable sensor as in claim 33, wherein the distance is within the range of from about 0.3 mm to about 2.5 mm.

47. An implantable sensor as in claim 33, wherein the distance is sufficient to increase the blood flow velocity at the sensing surface to from about 125% to about 200% of the blood flow velocity immediately proximal to the support structures.

48. An implantable sensor as in claim 33, further comprising a transmitter mounted to at least one of the support structures, for transmitting information from the sensor to an external receiver.

49. An implantable sensor as in claim 48, wherein an inductive link supplies power to the transmitter.

50. An implantable sensor as in claim 33, further comprising a thin film rechargeable battery carried by the support structures.

51. An implantable sensor as in claim 33, wherein the support structures comprise enlargeable frames.

52. An implantable sensor as in claim 51, wherein the support structures comprise expandable tubular bodies.

53. An implantable sensor as in claim 33, wherein the support structures comprise balloon expandable stents.

54. An implantable sensor as in claim 33, wherein the support structures comprise self expandable stents.