Analyte sensor

• US 20070027370A1
• Filed: 08/10/2006
• Published: 02/01/2007
• Est. Priority Date: 07/13/2004
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Boock, Robert, Brister, Mark, Brauker, James, Simpson, Peter, Rixman, Monica
• Granted Patent: US 9,986,942 B2
• Time in Patent Office: Days
• US Class Current: 600/309
• 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

Biointerface membranes are provided which can be utilized with implantable devices, such as devices for the detection of analyte concentrations in a biological sample. More particularly, methods for monitoring glucose levels in a biological fluid sample using an implantable analyte detection device incorporating such membranes are provided.

Claims

1. An analyte sensing device adapted for implantation into a host'"'"'s tissue, comprising:

a sensor configured to measure an analyte in a host, wherein the sensor comprises a biointerface configured to promote at least one function selected from the group consisting of increasing fluid bulk surrounding at least a portion of the sensor in vivo, increasing bulk fluid flow surrounding at least a portion of the sensor in vivo, and increasing diffusion rates surrounding at least a portion of the sensor in vivo.

2. The device of claim 1, wherein the biointerface comprises a spacer.

3. The device of claim 2, wherein the spacer comprises a mesh.

4. The device of claim 2, wherein the spacer comprises a hydrogel.

5. The device of claim 4, wherein the hydrogel comprises from about 20 wt. % to about 99 wt. % water.

6. The device of claim 4, wherein the hydrogel comprises from about 80 wt. % to about 99 wt. % water.

7. The device of claim 2, wherein the spacer comprises a shedding layer.

8. The device of claim 2, wherein the spacer is a fibrous structure.

9. The device of claim 2, wherein the spacer is a porous polymer membrane.

10. The device of claim 2, wherein the spacer comprises a material selected from the group consisting of polysulfone, polytetrafluoroethylene, polyvinylidene difluoride, polyacrylonitrile, silicone, polytetrafluoroethylene, expanded polytetrafluoroethylene, polyethylene-co-tetrafluoroethylene, polyolefin, polyester, polycarbonate, biostable polytetrafluoroethylene, polyurethane, polypropylene, polyvinylchloride, polyvinylidene fluoride, polyvinyl alcohol, polybutylene terephthalate, polymethylmethacrylate, polyether ether ketone, polyamides, cellulosic polymer, poly(ethylene oxide), poly(propylene oxide), hydrogel polymer, poly(2-hydroxyethyl methacrylate), hydroxyethyl methacrylate, high density polyethylene, acrylic copolymer, nylon, polyvinyl difluoride, polyanhydride, poly(1-lysine), poly (L-lactic acid), hydroxyethylmethacrylate, homopolymers thereof, copolymers thereof, di-block copolymers thereof, tri-block copolymers thereof, alternating copolymers thereof, random copolymers thereof, graft copolymers thereof, terpolymers thereof, and blends thereof.

11. The device of claim 2, wherein the spacer comprises a material selected from the group consisting of metal, ceramic, hydroxyapeptite, alumina, zirconia, carbon fiber, aluminum, calcium phosphate, titanium, titanium alloy, nintinol, stainless steel, CoCr alloy, and combinations thereof.

12. The device of claim 2, wherein the spacer has an average nominal pore size of from about 0.6 μ

m to about 20 μ

m.

13. The device of claim 2, wherein at least 50% of the pores of the spacer have an average size of from about 0.6 μ

m to about 20 μ

m.

14. The device of claim 1, wherein the biointerface is configured to provide a fluid pocket.

15. The device of claim 1, wherein the biointerface comprises a roughened surface.

16. The device of claim 15, wherein the roughened surface is a vasodilating surface.

17. The device of claim 1, wherein the biointerface comprises an irregular surface.

18. The device of claim 1, wherein the biointerface comprises a nanoporous material, a swellable material, or a collapsible material.

19. The device of claim 1, wherein the biointerface comprises an irritating superstructure.

20. The device of claim 19, wherein the irritating superstructure comprises a coiled silver wire.

21. The device of claim 1, wherein the biointerface comprises a biodegradable material.

22. The device of claim 21, wherein the biodegradable material is a biodegradable polymer.

23. The claim of 22, wherein the biodegradable polymer comprises an irritating polymer.

24. The device of claim 2, wherein the spacer comprises a self-assembling material.

25. The device of claim 24, wherein the self-assembling material comprises a self-assembling peptide.

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

27. The device of claim 25, wherein the bioactive agent is selected from the group consisting of anti-barrier cell agent, an anti-infective agent, a necrosing agent, an inflammatory agent, a growth factor, an angiogenic factor, an adjuvant, an antiplatelet agent, an anticoagulant, an ACE inhibitor, a cytotoxic agent, a vascularization compound, an anti-sense molecule, an enzyme, a metal, a hydrophilic biodegradable polymer, a glycolic acid-based polymer, a lactic acid-based polymer, polyethylene oxide, silver, and combinations thereof.

28. The device of claim 1, wherein the sensor is configured to measure a signal that is indicative of a quantity of the analyte within a fluid surrounding at least a portion of the sensor.

29. The device of claim 28, wherein the fluid surrounding at least a portion of the sensor comprises wound fluid.

30. The device of claim 1, further comprising electronics operably connected to the sensor and adapted for detecting a signal from the sensor, wherein the signal is indicative of a quantity of analyte within the host.

31. The device of claim 1, further comprising a housing adapted for placement adjacent to the host'"'"'s skin, wherein at least a portion of the electronics are disposed in the housing.

32. The device of claim 1, wherein the sensor is adapted for short-term implantation.

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

58. The device of claim 51, wherein the biointerface comprises a pro-inflammatory architecture.

34. An analyte sensing device adapted for implantation into a host'"'"'s tissue, comprising:

a sensor for measuring an analyte in the host, wherein the sensor comprises a biointerface configured to irritate a surrounding in vivo environment.

35. The device of claim 34, wherein the biointerface comprises a shedding layer.

36. The device of claim 34, wherein the biointerface comprises a roughened surface.

37. The device of claim 34, wherein the biointerface comprises an irritating superstructure.

38. The device of claim 37, wherein the irritating superstructure comprises a coiled silver wire.

39. The device of claim 34, wherein the biointerface comprises an irregular surface.

40. The device of claim 34, wherein the biointerface comprises a biodegradable material.

41. The device of claim 40, wherein the biodegradable material is a biodegradable polymer.

42. The claim of 40, wherein the biodegradable polymer comprises an irritating polymer.

43. The device of claim 34, wherein the biointerface comprises a bioactive agent.

44. The device of claim 43, wherein the bioactive agent is selected from the group consisting of an anti-barrier cell agent, an anti-infective agent, a necrosing agent, an inflammatory agent, a growth factor, an angiogenic factor, an adjuvant, an antiplatelet agent, an anticoagulant, an ACE inhibitor, a cytotoxic agent, a vascularization compound, an anti-sense molecule, an enzyme, a metal, a hydrophilic biodegradable polymer, a glycolic acid-based polymer, a lactic acid-based polymer, polyethylene oxide, silver, and combinations thereof.

45. The device of claim 34, wherein the sensor is configured to measure a signal that is indicative of a quantity of the analyte within a fluid surrounding at least a portion of the sensor.

46. The device of claim 34, wherein the fluid surrounding at least a portion of the sensor comprises wound fluid.

47. The device of claim 34, further comprising electronics operably connected to the sensor and adapted for detecting a signal from the sensor, wherein the signal is indicative of a quantity of the analyte within the host.

48. The device of claim 34, further comprising a housing adapted for placement adjacent to the host'"'"'s skin, wherein at least a portion of the electronics are disposed in the housing.

49. The device of claim 34, wherein the sensor is adapted for short-term implantation

50. The device of claim 34, wherein the sensor is a transcutaneous sensor.

51. An analyte sensing device adapted for implantation into a host'"'"'s tissue, comprising:

a sensor for measuring an analyte in a host, wherein the sensor comprises a biointerface configured to suppress wound healing around at least a portion of the sensor in vivo.

52. The device of claim 51, wherein the biointerface comprises a scavenging agent.

53. The device of claim 51, wherein the biointerface comprises a bioactive agent.

54. The device of claim 53, wherein the bioactive agent is selected from the group consisting of an anti-inflammatory agent, an anti-infective agent, an anesthetic, a growth factor, an angiogenic factor, an immunosuppressive agent, an antiplatelet agent, an anticoagulant, a scavenging agent, an anti-histamine, and combinations thereof.

55. The device of claim 53, wherein the bioactive agent comprises an anti-histamine.

56. The device of claim 51, wherein the biointerface comprises an architecture configured to suppress wounding.

57. The device of claim 51, wherein the biointerface comprises an anti-inflammatory architecture.

59. The device of claim 51, wherein the biointerface comprises an artificial protective coating.

60. The device of claim 59, wherein the artificial protective coating comprises a substance selected from the group consisting of albumin, fibrin, collagen, endothelial cells, wound closure chemicals, blood products, platelet-rich plasma, growth factors, and combinations thereof.

61. The device of claim 51, wherein the sensor is configured to measure a signal that is indicative of a quantity of the analyte within a fluid surrounding at least a portion of the sensor.

62. The device of claim 61, wherein the fluid surrounding at least a portion of the sensor comprises wound fluid.

63. The device of claim 51, further comprising electronics operably connected to the sensor and adapted for detecting a signal from the sensor, wherein the signal is indicative of a quantity of the analyte within the host.

64. The device of claim 51, further comprising a housing adapted for placement adjacent to the host'"'"'s skin, wherein at least a portion of the electronics are disposed in the housing.

65. The device of claim 51, wherein the sensor is adapted for short-term implantation

66. The device of claim 51, wherein the sensor is a transcutaneous sensor.

67. A method for detecting an analyte in a host, comprising:

providing an analyte sensing device adapted for transcutaneous insertion into the host, the device comprising a sensor for measuring the analyte in the host, wherein the sensor is configured to reduce noise in vivo;

inserting the sensor through the host'"'"'s skin and into the host;

waiting a first period of time, during which first period of time the sensor remains in the host, wherein the first period of time is sufficient for at least partial wound healing to occur;

initiating a sensor function; and

detecting a signal from the sensor, wherein the signal is indicative of a concentration of an analyte in the host.

68. The method of claim 67, wherein the first time period is at least about 1 hour.

69. The method of claim 67, wherein the first time period is at least about 24 hours.

70. The method of claim 67, wherein the first period of time is from about 1 hour to about 48 hours.

71. The method of claim 67, further comprising a step of waiting a second period of time during which the sensor remains in the host, wherein the step of waiting a second period of time is conducted after the step of initiating a sensor function and before the step of detecting a signal from the sensor.

72. The method of claim 71, wherein the second period of time is at least about 1 hour.

73. The method of claim 71, wherein the second period of time is at least about 24 hours.

74. The method of claim 71, wherein the second period of time is from about 1 hour to about 48 hours.