Device and method for determining analyte levels

• US 7,110,803 B2
• Filed: 09/09/2003
• Issued: 09/19/2006
• Est. Priority Date: 03/04/1997
• Status: Expired due to Fees

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Shults, Mark C., Updike, Stuart J., Rhodes, Rathbun K.
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US10/657,843
• Publication Number:
  US 20040045879A1
• Time in Patent Office: 1,106 Days
• Field of Search: 600345-350, 204/415
• US Class Current: 600/347
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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

Devices and methods for determining analyte levels are described. The devices and methods allow for the implantation of analyte-monitoring devices, such as glucose monitoring devices, that result in the delivery of a dependable flow of blood to deliver sample to the implanted device. The devices comprise a unique microarchitectural arrangement in the sensor region that allows accurate data to be obtained over long periods of time.

Claims

1. A wholly implantable glucose monitoring device, the device comprising:

a) a housing and a sensor, wherein the sensor is situated on the housing, wherein the sensor comprises a member for determining an amount of glucose in a biological fluid of a tissue of a host, and wherein the tissue of the host is adapted to be adjacent to a first side of the housing;

b) an angiogenic layer situated on said sensor, wherein the angiogenic layer promotes adequate microcirculatory delivery of analyte and oxygen to the sensor; and

c) a securing member for securing the device to the tissue of the host, wherein the securing member is situated on the first side of the housing wherein one of the angiogenic layer and securing member is more proximal to the housing than other of the angiogenic layer and the securing member.

2. The device of claim 1, further comprising a radiotelemetry device for transmitting data, wherein the radiotelemetry device is situated within the housing.

3. The device of claim 1,

wherein the member comprises a sensor interface dome, wherein the sensor interface dome comprises a membrane assembly, wherein the membrane assembly comprises the angiogenic layer.

4. The device of claim 1, wherein the securing member comprises a material selected from the group consisting of polyester, polypropylene cloth, polytetrafluoroethylene felts and expanded polytetrafluoroethylene.

5. The device of claim 1, wherein the angiogenic layer is selected from the group consisting of expanded polytetrafluoroethylene, polyester, hydrophilic polyvinylidene fluoride, mixed cellulose esters, polyvinyl chloride, polypropylene, polysulfone, and polymethacrylate.

6. The device of claim 1, wherein the glucose determining member comprises an electrochemical cell.

7. The device of claim 1, wherein the glucose determining member measures surface plasmon resonance.

8. The device of claim 1, wherein the glucose determining member measures surface acoustic waves.

9. The device of claim 1, wherein the glucose determining member measures optical absorbance in the long wave infrared region.

10. The device of claim 1, wherein the glucose determining member measures optical rotation of polarized light.

11. The device of claim 1, wherein the housing comprises a second side situated opposite to the first side, wherein the second side is substantially smooth.

12. The device of claim 1, wherein the securing member is situated substantially only on the first side of the housing.

13. The device of claim 1, wherein the securing member is situated on more than one side of said housing.

14. The device of claim 1, wherein the sensor is convex with reference to the housing.

15. The device of claim 1, wherein the sensor comprises a membrane assembly.

16. The device of claim 15, wherein the membrane assembly comprises an enzyme membrane adapted to:

1) control a flux of oxygen and the analyte,

     2) enyzmatically react with the analyte, and

     3) restrict passage of a species that interferes with a measurement of the analyte.

17. The device of claim 16, wherein the enzyme membrane is selected from the group consisting of polyethylene, polyvinylchloride, tetrafluoroethylene, polytetrafluoroethylene, polypropylene, polyacrylamide, polymethyl methacrylate, silicone polymer, polycarbonate, collagen, polyurethane, polyurethane block copolymers, cellulose acetate, and cellulosic polymer.

18. The device of claim 16, wherein the enzyme membrane comprises a resistance layer, wherein the resistance layer restricts transport of glucose through the enzyme membrane.

19. The device of claim 18, wherein the resistance layer comprises a polymer membrane with an oxygen-to-glucose permeability ratio of approximately 200:

1.

20. The device of claim 16, wherein the enzyme membrane comprises a comprises glucose oxidase.

21. The device of claim 16, wherein the enzyme membrane comprises an interference layer, wherein the interference layer comprises a hydrophobic membrane substantially permeable to hydrogen peroxide.

22. The device of claim 21, wherein the interference layer comprises a hydrophobic membrane substantially impermeable to a chemical composition comprising a molecular weight substantially greater than a molecular weight of hydrogen peroxide.

23. The device of claim 16, wherein the enzyme membrane comprises an electrolyte layer, wherein the electrolyte layer comprises a semipermeable hydrophilic coating.

24. The device of claim 23, wherein the electrolyte layer comprises a curable copolymer, wherein the curable copolymer comprising comprises a urethane polymer and a hydrophilic film-forming polymer.

25. A device for measuring glucose in a tissue of a host, the device comprising:

a wholly implantable device comprising a analyte sensor having an interface for communicating with a tissue of the host, the interface comprising an angiogenic layer for promoting adequate microcirculatory delivery of glucose and oxygen to the sensor, and an outermost stability layer for promoting formation of a stable foreign body capsule structure wherein one of the angiogenic layer and the stability layer.

26. The device of claim 25, wherein the angiogenic layer is selected from the group consisting of expanded polytetrafluoroethylene, polyester, hydrophilic polyvinylidene fluoride, mixed cellulose esters, polyvinyl chloride, polypropylene, polysulfone, and polymethacrylate.

27. The device of claim 25, wherein the outermost stability layer comprises a polyester.

28. The device of claim 25, wherein the apparatus comprises a housing, and wherein the sensor is convex with reference to the housing.

29. The device of claim 25, wherein the sensor comprises a membrane assembly.

30. The device of claim 29, wherein the membrane assembly is selected from the group consisting of polyethylene, polyvinyichioride, tetrafluoroethylene, polytetrafluoroethylene, polypropylene, polyacrylamide, polymethyl methacrylate, silicone polymer, polycarbonate, collagen, polyurethane, polyurethane block copolymers, cellulose acetate, and cellulosic polymer.

31. The device of claim 29, wherein the membrane assembly comprises an enzyme membrane adapted to:

1) control a flux of oxygen and the analyte,

     2) enyzmatically react with the analyte, and

     3) restrict passage of a species that interferes with a measurement of the analyte.

32. The device of claim 31, wherein the enzyme membrane comprises a resistance layer, wherein the resistance layer restricts transport of glucose through the enzyme membrane.

33. The device of claim 32, wherein the resistance layer comprises a polymer membrane with an oxygen-to-glucose permeability ratio of approximately 200:

1.

34. The device of claim 31, wherein the enzyme membrane comprises an enzyme layer, wherein the enzyme layer comprises glucose oxidase.

35. The device of claim 31, wherein the enzyme membrane comprises an interference layer, wherein the interference layer comprises a hydrophobic membrane substantially permeable to hydrogen peroxide.

36. The device of claim 35, wherein the interference layer comprises a hydrophobic membrane substantially impermeable to a chemical composition comprising a molecular weight substantially greater than a molecular weight of hydrogen peroxide.

37. The device of claim 31, wherein the enzyme membrane comprises an electrolyte layer, wherein the electrolyte layer comprises a semipermeable hydrophilic coating.

38. The device of claim 37, wherein the electrolyte layer comprises a curable copolymer, wherein the curable copolymer comprises a urethane polymer and a hydrophilic film-forming polymer.

39. The device of claim 25, further comprising a radiotelemetry device for transmitting data, wherein the radiotelemetry device is situated within the housing.

40. The device of claim 25, wherein the apparatus comprises a sensor interface dome.

41. An analyte-measuring device suitable for implantation in a host, the device comprising:

a housing, wherein the housing comprises a securing member for preventing movement of the device after implantation;

a sensor for determining an amount of an analyte in the host; and

an angiogenic layer, wherein the angiogenic layer promotes development of blood vessels microcirculation wherein one of the angiogenic layer and securing member is more proximal to the housing the other of the angiogenic layer and the securing member.

42. The analyte-measuring device of claim 41, further comprising an electrolyte layer, wherein the electrolyte layer maintains hydrophilicity on a surface of the sensor.

43. The analyte-measuring device of claim 41, further comprising an interference layer, wherein the interference layer restricts passage of a species that interferes with a measurement of the analyte.

44. The analyte-measuring device of claim 41, further comprising an enzyme layer, wherein the enzyme layer comprises a component for catalyzing an enzyme reaction.

45. The analyte-measuring device of claim 41, further comprising a resistance layer, wherein the resistance layer controls a flux of oxygen and the analyte through the membrane assembly.

46. The analyte-measuring device of claim 41, further comprising a bioprotective layer, wherein the bioprotective layer blocks passage of macrophages.

47. The device of claim 41, wherein the sensor is convex with reference to the housing.

48. The device of claim 41, wherein the sensor comprises a membrane assembly.

49. The device of claim 48, wherein the membrane assembly is selected from the group consisting of polyethylene, polyvinylchloride, tetrafluoroethylene, polytetrafluoroethylene, polypropylene, polyacrylamide, polymethyl methacrylate, silicone polymer, polycarbonate, collagen, polyurethane, polyurethane block copolymers, cellulose acetate, and cellulosic polymer.

50. The device of claim 48, wherein the membrane assembly comprises an enzyme membrane adapted to:

1) control a flux of oxygen and the analyte,

     2) enyzmatically react with the analyte, and

     3) restrict passage of a species that interferes with a measurement of the analyte.

51. The device of claim 50, wherein the enzyme membrane comprises a resistance layer, wherein the resistance layer restricts transport of glucose through the enzyme membrane.

52. The device of claim 51, wherein the resistance layer comprises a polymer membrane with an oxygen-to-glucose permeability ratio of approximately 200:

1.

53. The device of claim 50, wherein the enzyme membrane comprises an enzyme layer, wherein the enzyme layer comprises glucose oxidase.

54. The device of claim 50, wherein the enzyme membrane comprises an interference layer, wherein the interference layer comprises a hydrophobic membrane substantially permeable to hydrogen peroxide.

55. The device of claim 54, wherein the interference layer comprises a hydrophobic membrane substantially impermeable to a chemical composition comprising a molecular weight substantially greater than a molecular weight of hydrogen peroxide.

56. The device of claim 50, wherein the enzyme membrane comprises an electrolyte layer, wherein the electrolyte layer comprises a semipermeable hydrophilic coating.

57. The device of claim 56, wherein the electrolyte layer comprises a curable copolymer, wherein the curable copolymer comprises a urethane polymer and a hydrophilic film-forming polymer.

58. The device of claim 41, further comprising a radiotelemetry device for transmitting data, wherein the radiotelemetry device is situated within the housing.

59. The device of claim 41, wherein the device comprises a sensor interface dome.

60. An analyte-measuring device suitable for implantation in a host, the device comprising:

a housing, wherein the housing comprises a securing member for preventing movement of the device after implantation;

a sensor for determining an amount of an analyte in the host; and

a stability layer, wherein the stability layer promotes formation of a stable foreign body capsule structure wherein one of the stability layer and securing member is more proximal to the housing than other of the stability layer and the securing member.

61. The device of claim 60, wherein the sensor is convex with reference to the housing.

62. The device of claim 60, wherein the sensor comprises a membrane assembly.

63. The device of claim 62, wherein the membrane assembly is selected from the group consisting of polyethylene, polyvinylchloride, tetrafluoroethylene, polytetrafluoroethylene, polypropylene, polyacrylamide, polymethyl methacrylate, silicone polymer, polycarbonate, collagen, polyurethane, polyurethane block copolymers, cellulose acetate, and cellulosic polymer.

64. The device of claim 62, wherein the membrane assembly comprises an enzyme membrane adapted to:

1) control a flux of oxygen and the analyte,

     2) enyzmatically react with the analyte, and

     3) restrict passage of a species that interferes with a measurement of the analyte.

65. The device of claim 64, wherein the enzyme membrane comprises a resistance layer, wherein the resistance layer restricts transport of glucose through the enzyme membrane.

66. The device of claim 65, wherein the resistance layer comprises a polymer membrane with an oxygen-to-glucose permeability ratio of approximately 200:

1.

67. The device of claim 64, wherein the enzyme membrane comprises an enzyme layer, wherein the enzyme layer comprises glucose oxidase.

68. The device of claim 64, wherein the enzyme membrane comprises an interference layer, wherein the interference layer comprises a hydrophobic membrane substantially permeable to hydrogen peroxide.

69. The device of claim 68, wherein the interference layer comprises a hydrophobic membrane substantially impermeable to a chemical composition comprising a molecular weight substantially greater than a molecular weight of hydrogen peroxide.

70. The device of claim 64, wherein the enzyme membrane comprises an electrolyte layer, wherein the electrolyte layer comprises a semipermeable hydrophilic coating.

71. The device of claim 70, wherein the electrolyte layer comprises a curable copolymer, wherein the curable copolymer comprises a urethane polymer and a hydrophilic film-forming polymer.

72. The device of claim 60, further comprising a radiotelemetry device for transmitting data, wherein the radiotelemetry device is situated within the housing.

73. The device of claim 60, wherein the device comprises a sensor interface dome.