Integrated catalytic protection of oxidation sensitive materials

Patent metadata

Field	Value
Publication number	US-9681824-B2
Application number	US-201213421013-A
Country	US
Kind code	B2
Filing date	Mar 15, 2012
Priority date	Mar 15, 2011
Publication date	Jun 20, 2017
Grant date	Jun 20, 2017

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.

First claim

The invention claimed is:

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.

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 graf

Assignees

• Colvin Jr Arthur E
• Jiang Hui
• Senseonics Inc

Inventors

• Colvin Jr Arthur E
• Jiang Hui

Classifications

• A61B5/076 Primary

  Permanent implantation · CPC title

• A61B5/1459 Primary

  invasive, e.g. introduced into the body by a catheter · CPC title

• A61B5/14532

  for measuring glucose, e.g. by tissue impedance measurement · CPC title

• A61B2562/18

  Shielding or protection of sensors from environmental influences, e.g. protection from mechanical damage · CPC title

• A61B5/145

  Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value {; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue} (non-radiation detecting or locating of foreign bodies in blood A61B5/06) · CPC title