Integrated catalytic protection of oxidation sensitive materials

• US 9,681,824 B2
• Filed: 03/15/2012
• Issued: 06/20/2017
• Est. Priority Date: 03/15/2011
• Status: Active Grant

• Current Assignee: Senseonics, Incorporated (Senseonics Holdings, Inc.)
• Original Assignee: Senseonics, Incorporated (Senseonics Holdings, Inc.)
• Inventors: Colvin, Jr., Arthur E., Jiang, Hui
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US13/421,013
• Publication Number:
  US 20120238842A1
• Time in Patent Office: 1,923 Days
• Field of Search: 600310-344
• CPC Class Codes: A61B 2562/028 Microscale sensors, e.g. electromechanical sensors [MEMS]
• CPC Class Codes: A61B 2562/162 Capsule shaped sensor housings, e.g. for swallowing or implantation
• CPC Class Codes: A61B 2562/18 Shielding or protection of sensors from environmental influences, e.g. protection from mechanical damage
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence

Abstract

An implantable device with in vivo functionality, where the functionality of the device is negatively affected by ROS typically associated with inflammation reaction as well as chronic foreign body response as a result of tissue injury, is at least partially surrounded by a protective material, structure, and/or a coating that prevents damage to the device from any inflammation reactions. The protective material, structure, and/or coating is a biocompatible metal, preferably silver, platinum, palladium, gold, manganese, or alloys or oxides thereof that decomposes reactive oxygen species (ROS), such as hydrogen peroxide, and prevents ROS from oxidizing molecules on the surface of or within the device. The protective material, structure, and/or coating thereby prevents ROS from degrading the in vivo functionality of the implantable device.

Claims

1. A sensor having an in vivo functionality, the sensor comprising:

a sensor body encasing a photosensitive detector element and a light source, the sensor body comprising an exterior surface and a groove in the exterior surface;

a porous sensor graft on at least the groove in the exterior surface of the sensor body, wherein the porous graft comprises one or more indicator macromolecules; and

a protective material in close proximity to the porous sensor graft and surrounding one or more of (i) a portion or all of the porous sensor graft and (ii) a portion of the exterior surface of the sensor body, wherein;

(1) the protective material prevents or reduces degradation or interference of the porous sensor graft due to inflammation reactions and/or foreign body response;

(2) the protective material comprises a metal or metal oxide which catalytically decomposes or inactivates in vivo reactive oxygen species or biological oxidizers; and

(3) the protective material does not completely surround the sensor body.

2. The sensor of claim 1, wherein the sensor is for monitoring glucose levels.

3. The sensor of claim 1, wherein the one or more indicator macromolecules comprises a phenylboronic acid residue.

4. The sensor of claim 1, wherein the metal or metal oxide comprises silver, palladium, platinum, manganese, or alloys, or gold-inclusive alloys, or combinations thereof.

5. The sensor of claim 1, wherein the porous sensor graft is made from a material that is sensitive to, or is susceptible to damage from, oxidation.

6. The sensor of claim 1, wherein the protective material is in close proximity to at least a part of the sensor body that comprises a polymer.

7. The sensor of claim 1, wherein the protective material is from about 0.5 nm to about 2.5 mm thick.

49. The sensor of claim 1, wherein sensor body has a 360 degree cut shape.

50. The sensor of claim 1, wherein the sensor body has a saddle-cut shape.

51. The sensor of claim 1, wherein the protective material is applied by sputter deposition.

52. The sensor of claim 1, wherein the protective material is a structure that comprises a coil, mesh, weave, or perforated and/or slotted structure at least partially surrounding the device.

8. A sensor having an in vivo functionality, the sensor comprising:

a sensor body encasing a photosensitive detector element and a light source, the sensor body comprising an exterior surface and having a saddle-cut shape in the exterior surface;

a porous sensor graft on at least a portion of the exterior surface of the sensor body, wherein the porous graft comprises one or more indicator macromolecules; and

a layer of protective coating applied onto one or more of (i) a portion or all of the porous sensor graft and (ii) a portion of the exterior surface of the sensor body, wherein;

(1) the protective coating prevents or reduces degradation or interference of the porous sensor graft from inflammation reactions and/or foreign body response;

(2) the protective coating comprises a metal or metal oxide which catalytically decomposes or inactivates in vivo reactive oxygen species or biological oxidizers; and

(3) the layer of protective coating does not completely surround the sensor body.

9. The sensor of claim 8, wherein the sensor is for monitoring glucose levels.

10. The sensor of claim 8, wherein the one or more indicator macromolecules comprises a phenylboronic acid residue.

11. The sensor of claim 8, wherein the protective coating is applied by sputter deposition.

12. The sensor of claim 8, wherein the metal or metal oxide comprises silver, palladium, platinum, manganese, or alloys, or gold-inclusive alloys, or combinations thereof.

13. The sensor of claim 8, wherein the protective coating is from about 0.5 nm to about 500 nm thick.

14. The sensor of claim 8, wherein the protective coating is from about 1 nm to about 20 nm thick.

15. The sensor of claim 8, wherein the protective coating is from about 3 nm to about 6 nm thick.

16. The sensor of claim 8, wherein the protective coating is at least about 1 nm thick.

17. The sensor of claim 8, wherein the porous sensor graft is made from a material that is sensitive to, or is susceptible to damage from, oxidation.

18. The sensor of claim 8, wherein the protective coating is applied onto at least a part of the sensor body that comprises a polymer.

19. The sensor of claim 8, wherein the sensor has an in vivo functionality for a substantially elongated period of time, as compared to the useful life of a separate material with in vivo utility but without the layer of protective coating, following implant in an environment where the sensor is exposed to inflammation reactions and/or foreign body response.

20. A method for using a sensor for in vivo applications comprising:

implanting a sensor in a subject body, wherein the sensor has an in vivo functionality and comprises a sensor body encasing a photosensitive detector element and a light source, comprising an exterior surface, and having a saddle-cut shape in the exterior surface;

a porous sensor graft on at least a portion of the exterior surface of the sensor body, the porous graft comprising one or more indicator macromolecules; and

a layer of a protective coating on one or more of (i) a portion or all of the porous sensor graft and (ii) a portion of the exterior surface of the sensor body, wherein;

(1) the protective coating prevents or reduces degradation or interference of the porous sensor graft due to inflammation reactions and/or foreign body response;

(2) the protective coating comprises a metal or metal oxide which catalytically decomposes or inactivates in vivo reactive oxygen species or biological oxidizers; and

(3) the protective coating does not completely surround the sensor body.

21. The method of claim 20, wherein the in vivo functionality of the sensor is to operate as a sensor designed to detect glucose.

22. The method of claim 20, wherein the one or more indicator molecules comprises a phenylboronic acid residue.

23. The method of claim 20, wherein the protective coating is applied by sputter deposition.

24. The method of claim 20, wherein the metal or metal oxide comprises silver, palladium, platinum, manganese, or alloys, or gold-inclusive alloys, or combinations thereof.

25. The method of claim 20, wherein the protective coating is from about 0.5 nm to about 500 nm thick.

26. The method of claim 20, wherein the protective coating is from about 1 nm to about 20 nm thick.

27. The method of claim 20, wherein the protective coating is from about 3 nm to about 6 nm thick.

28. The method of claim 20, wherein the protective coating is at least about 1 nm thick.

29. The method of claim 20, wherein the in vivo functionality of the sensor is to operate as a sensor designed to detect a target analyte.

30. The method of claim 20, wherein the porous sensor graft is made from a material that is sensitive to, or is susceptible to damage from, oxidation.

31. The method of claim 20, wherein the protective coating is applied onto at least a part of the sensor body that comprises a polymer.

32. The method of claim 20, wherein the sensor has an in vivo functionality for a substantially elongated period of time, as compared to the useful life of a separate material with in vivo utility but without the layer of protective coating, following implant in an environment where the sensor is exposed to inflammation reactions and/or foreign body response.

33. A method for detecting the presence or concentration of an analyte in an in vivo sample, said method comprising:

(a) exposing the sample to a porous sensor graft of a sensor, the porous sensor graft having a detectable quality that changes when the porous sensor graft is exposed to the analyte, said sensor comprising a sensor body encasing a photosensitive detector element and a light source, comprising an exterior surface, and having a saddle-cut shape in the exterior surface;

a porous sensor graft on at least a portion of the exterior surface of the sensor body, the porous graft comprising one or more indicator macromolecules; and

a layer of protective coating applied onto one or more of (i) a portion or all of the porous sensor graft and (ii) a portion of the exterior surface of the sensor body, wherein;

(1) the protective coating prevents or reduces degradation or interference of the porous sensor graft from inflammation reactions and/or foreign body response;

(2) the protective coating comprises a metal or metal oxide which catalytically decomposes or inactivates in vivo reactive oxygen species or biological oxidizers; and

(3) the protective coating does not completely surround the sensor body, such that the sensor has enhanced resistance to degradation or interference as compared to a corresponding sensor without the protective coating; and

(b) measuring any change in said detectable quality to thereby determine the presence or concentration of said analyte in said sample.

34. The method of claim 33, wherein the analyte is glucose.

35. The method of claim 33, wherein the one or more indicator molecules comprises a phenylboronic acid residue.

36. The method of claim 33, wherein the protective coating is applied by sputter deposition.

37. The method of claim 33, wherein the metal or metal oxide comprises silver, palladium, platinum, manganese, or alloys, or gold-inclusive alloys or combinations thereof.

38. The method of claim 33, wherein the protective coating is from about 0.5 nm to about 500 nm thick.

39. The method of claim 33, wherein the protective coating is from about 1 nm to about 20 nm thick.

40. The method of claim 33, wherein the protective coating is from about 3 nm to about 6 nm thick.

41. The method of claim 33, wherein the protective coating is at least about 1 nm thick.

42. The method of claim 33, wherein the porous sensor graft is made from a material that is sensitive to, or is susceptible to damage from, oxidation.

43. The method of claim 33, wherein the protective coating is applied onto at least a part of one or more of the sensor body that comprises a polymer.

44. The method of claim 33, wherein the sensor has an in vivo functionality for a substantially elongated period of time, as compared to the useful life of a separate material with in vivo utility but without the layer of protective coating, following implant in an environment where the sensor is exposed to inflammation reactions and/or foreign body response.

45. An implantable glucose sensor for determining the presence or concentration of glucose in an animal, said sensor comprising:

(a) a sensor body having an outer surface surrounding said sensor body and a groove in the outer surface;

(b) a radiation source in said sensor body which emits radiation within said sensor body;

(c) an indicator element that is affected by the presence or concentration of glucose in said animal, said indicator element being on at least the groove in said outer surface of said sensor body;

(d) a photosensitive element located in said sensor body and positioned to receive radiation within the sensor body, said photosensitive element configured to generate a signal responsive to radiation received from said indicator element and which is indicative of the presence or concentration of glucose in said animal; and

(e) a protective barrier comprising silver, palladium, platinum, manganese, or alloys, or gold-inclusive alloys, or combinations thereof, surrounding one or more of (i) a portion or all of said indicator element and (ii) a portion of said outer surface of said sensor body, wherein the protective barrier surrounds one or more of (1) a portion or all of said indicator element and (2) a portion of said outer surface of said sensor body, and the protective barrier does not completely surround the sensor body.

46. The sensor of claim 45, wherein the outer surface is comprised of a polymer.

47. The sensor of claim 45, wherein the indicator element comprises at least one indicator macromolecule.

48. The sensor of claim 45, wherein the protective barrier is further comprised of oxides of silver, platinum, palladium, manganese, alloys, or gold-inclusive alloys, or combinations thereof.

53. The sensor of claim 45, wherein the protective barrier is a structural encasement in the form of a wire, mesh, weave, or a perforated and/or slotted encasement at least partially surrounding said porous graft.

54. The sensor of claim 45, wherein the protective barrier is a coating directly covering at least a part of said porous graft.

55. The sensor of claim 45, wherein sensor body has a 360 degree cut shape.

56. The sensor of claim 45, wherein the sensor body has a saddle-cut shape.

57. The sensor of claim 45, wherein the protective barrier is applied by sputter deposition.