PROTECTIVE SHELL FOR AN IN VIVO SENSOR MADE FROM RESORBABLE POLYMER

• US 20100298674A1
• Filed: 04/21/2010
• Published: 11/25/2010
• Est. Priority Date: 04/21/2009
• Status: Abandoned Application

• Current Assignee: Sensors For Medicine and Science Incorporated
• Original Assignee: Sensors For Medicine and Science Incorporated
• Inventors: Colvin, Jason D., Colvin, Arthur E. JR.
• Application Number:
  US12/764,389
• Publication Number:
  US 20100298674A1
• Time in Patent Office: Days
• US Class Current: 600/316
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• 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
• CPC Class Codes: A61B 5/6861 Capsules, e.g. for swallowing or implanting

Abstract

An implantable device with in vivo functionality, where the functionality of the device is negatively affected by the inflammation reaction generally associated with tissue injury, encapsulated by a protective coating that prevents damage to the device from any inflammation reactions. The protective coating is designed to persist for a set period of time, generally until after the inflammation reaction of the surrounding in vivo environment in response to the injury caused by the implantation procedure has concluded. The protective coating is further designed to “resorb” (i.e. to dissociate from the device, dissolve, and be absorbed into the surrounding environment) after a set period of time, allowing the device to perform its in vivo functionality unhindered without loss of performance.

Claims

1. A device comprising:

(a) an implantable device which has an in vivo functionality and;

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

(1) the protective coating prevents or reduces degradation or interference of the implantable device from inflammation reactions; and

(2) the protective coating is designed to resorb over a period of time under in vivo conditions.

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

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

4. The device of claim 1, wherein the protective coating is applied to the device by dipping the device in the coating material.

5. The device of claim 1, wherein the protective coating is applied to the device by spraying the coating onto the device.

6. The device of claim 1, wherein the protective coating is applied to the device by thermal extrusion of the coating onto the device.

7. The device of claim 1, wherein the protective coating is a physiologically compatible material comprising one or more polyanhydrides.

8. The device of claim 7, wherein the one or more polyanhydrides comprises poly(sebacic acid) and/or poly(1,3-bis(p-carboxyphenoxy)propane-co-sebacic acid).

9. The device of claim 1, wherein the protective coating is a physiologically compatible material comprising processed collagen.

10. The device of claim 1, wherein the protective coating is a physiologically compatible material comprising one or more polyesters.

11. The device of claim 10, wherein the one or more polyesters comprises polyglycolic acid and/or polylactic acid, or copolymers thereof.

12. The device of claim 1, wherein the layer of protective coating is from about 5 to about 200 microns thick.

13. The device of claim 12, wherein the layer of the protective coating is from about 20 to about 30 microns thick.

14. The device of claim 1, wherein the period of time is from about 4 to about 5 days.

15. The device of claim 2, wherein the sensor comprises a body surrounding a photosensitive detector element and a light source, and further wherein the external surface of the sensor body comprises a matrix layer that comprises one or more indicator molecules.

16. The device of claim 15, wherein the one or more indicator molecules comprises a phenylboronic acid residue.

17. The device of claim 15, wherein the sensor further comprises a power source and a transmitter surrounded by the sensor body.

18. A method for using an implantable device in in vivo applications comprising:

(a) providing an implantable device which has an in vivo functionality, and which comprises a layer of a protective coating on the device wherein;

(1) the protective coating prevents or reduces degradation or interference of the device from inflammation reactions; and

(2) during use the protective coating resorbs into the surrounding environment over a period of time; and

(b) implanting the implantable device in a subject body.

19. The method of claim 18, wherein the in vivo functionality of the implantable device is to operate as a sensor designed to detect a target analyte.

20. The method of claim 19, wherein the in vivo functionality of the implantable device is to operate as a sensor designed to detect glucose.

21. The method of claim 18, wherein the protective coating is applied by spraying the protective coating onto the implantable device.

22. The method of claim 18, wherein the protective coating is applied by dipping the implantable device into a reservoir of the protective coating.

23. The method of claim 18, wherein the protective coating is applied by thermal extrusion onto the implantable device.

24. The method of claim 18, wherein the protective coating comprises one or more of processed collagen, polyesters, or polyanhydrides.

25. The method of claim 18, wherein the protective coating is from about 5 to about 200 microns thick.

26. The method of claim 25, wherein the protective coating is from about 20 to about 30 microns thick.

27. The method of claim 18, wherein the protective coating resorbs into the surrounding environment over a period of about 4 to about 5 days.

28. The method of claim 19, wherein the sensor comprises a sensor body surrounding a photosensitive detector element and a light source, and further wherein the external surface of the sensor body comprises a matrix layer that comprises one or more indicator molecules.

29. The method of claim 28, wherein the one or more indicator molecules comprises a phenylboronic acid residue.

30. The method of claim 28, wherein the sensor further comprises a power source and a transmitter surrounded by the sensor body.

31. 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 device having a detectable quality that changes when the device is exposed to the analyte, said device comprising a layer of protective coating applied onto the implantable device wherein;

(1) the protective coating prevents or reduces degradation or interference of the device from inflammation reactions; and

(2) the protective coating is designed to resorb over a period of time under in vivo conditions,

such that the device has enhanced resistance to degradation or interference as compared to a corresponding device 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.

32. The method of claim 31, wherein the analyte is glucose.

33. The method of claim 31, wherein the protective coating comprises one or more of processed collagen, polyesters, or polyanhydrides.

34. The method of claim 31, wherein the protective coating is from about 5 to about 200 microns thick.

35. The method of claim 34, wherein the protective coating is from about 20 to about 30 microns thick.

36. The method of claim 31, wherein the protective coating resorbs into the surrounding environment over a period of about 4 to about 5 days.

37. The method of claim 31, wherein the device comprises a sensor body surrounding a photosensitive detector element and a light source, and further wherein the external surface of the sensor body comprises a matrix layer that comprises one or more indicator molecules.

38. The method of claim 37, wherein the one or more indicator molecules comprises a phenylboronic acid residue.

39. The method of claim 37, wherein the sensor further comprises a power source and a transmitter surrounded by the sensor body.