Integrated catalytic protection of oxidation sensitive materials

• US 10,674,937 B2
• Filed: 06/15/2017
• Issued: 06/09/2020
• 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 F
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US15/623,474
• Publication Number:
  US 20180146885A1
• Time in Patent Office: 1,090 Days
• Field of Search: None
• 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 system comprising:

(a) a device configured for implantation or insertion into the body of an animal; and

(b) a protective material in close proximity to a surface of the device, wherein;

(1) the protective material prevents or reduces degradation or interference of the device 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 thickness of the protective material is in a range from about 1 nm to about 20 nm.

2. The system of claim 1, wherein the device is a sensor.

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

4. The system of claim 2, wherein the sensor comprises a body at least partially surrounding a photosensitive detector element and a light source, and further wherein an external surface of the sensor body comprises a porous sensor graft layer that comprises one or more indicator macromolecules.

5. The system of claim 4, wherein the one or more indicator macromolecules comprises a phenylboronic acid residue.

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

7. The system of claim 1, wherein the device is a material that is sensitive to, or is susceptible to damage from, oxidation.

8. The system of claim 1, wherein the protective structure is in close proximity to at least a part of the device that comprises a polymer.

9. The system of claim 1, wherein the thickness of the protective material is in a range from about 3 nm to about 6 nm.

10. A system comprising:

(a) a device configured for implantation or insertion into the body of an animal; and

(b) a layer of protective coating applied onto the device wherein;

(1) the protective coating prevents or reduces degradation or interference of the device 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 thickness of the protective coating is in a range from about 1 nm to about 20 nm.

11. The system of claim 10, wherein the device is a sensor.

12. The system of claim 11, wherein the sensor is for monitoring glucose levels.

13. The system of claim 11, wherein the sensor comprises a body surrounding a photosensitive detector element and a light source, and further wherein an external surface of the sensor body comprises a porous sensor graft layer that comprises one or more indicator macromolecules.

14. The system of claim 13, wherein the one or more indicator macromolecules comprises a phenylboronic acid residue.

15. The system of claim 13, wherein the sensor body has a saddle-cut shape.

16. The system of claim 10, wherein the protective coating is applied by sputter deposition.

17. The system of claim 10, wherein the metal or metal oxide comprises silver, palladium, platinum, manganese, or alloys, or gold-inclusive alloys, or combinations thereof.

18. The system of claim 10, wherein the thickness of the protective coating is in a range from about 3 nm to about 6 nm.

19. The system of claim 10, wherein the thickness of the protective coating is about 1 nm thick.

20. The system of claim 10, wherein the device is a material that is sensitive to, or is susceptible to damage from, oxidation.

21. The system of claim 10, wherein the protective coating is applied onto at least a part of the device that comprises a polymer.

22. The system of claim 10, wherein the device 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 implantable device is exposed to inflammation reactions and/or foreign body response.

23. A 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;

(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 positioned in close proximity to at least a portion of 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 emit 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 coating comprising silver, palladium, platinum, manganese, or alloys, or gold-inclusive alloys, or combinations thereof, at least partially covering said indicator element, wherein the thickness of the protective barrier is in a range from about 1 nm to about 20 nm.

24. The sensor of claim 23, wherein the outer surface is comprised of a polymer.

25. The sensor of claim 23, wherein the indicator element comprises at least one indicator macromolecule.

26. The sensor of claim 23, wherein the protective coating is further comprised of oxides of silver, platinum, palladium, manganese, alloys, or gold-inclusive alloys, or combinations thereof.