DRUG ELUTION FOR IN VIVO PROTECTION OF BIO-SENSING ANALYTES

• US 20150057509A1
• Filed: 08/21/2014
• Published: 02/26/2015
• Est. Priority Date: 08/21/2013
• Status: Active Grant

• Current Assignee: Senseonics, Incorporated (Senseonics Holdings, Inc.)
• Original Assignee: Senseonics, Incorporated (Senseonics Holdings, Inc.)
• Inventors: Huffstetler, Philip, Emken, Jeremy, Whitehurst, Todd
• Granted Patent: US 9,931,068 B2
• Time in Patent Office: Days
• US Class Current: 600/309
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14556 by fluorescence A61B5/14555 takes precedence
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6847 mounted on an invasive device
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04

Abstract

A sensor (e.g., an optical sensor) that may be implanted within a living animal (e.g., a human) and may be used to measure an analyte (e.g., glucose or oxygen) in a medium (e.g., interstitial fluid, blood, or intraperitoneal fluid) within the animal. The sensor may include a sensor housing, an analyte indicator covering at least a portion of the sensor housing, and one or more therapeutic agents. The one or more therapeutic agents may reduce deterioration of the analyte indicator. The one or more therapeutic agents may be incorporated within the analyte indicator, a membrane covering at least a portion of the analyte indicator, and/or one or more drug eluting polymer matrices, which may be external to or within the sensor housing.

Claims

1. A sensor for measurement of an analyte in a medium within a living animal, the sensor comprising:

a sensor housing;

an analyte indicator covering at least a portion of the sensor housing; and

one or more therapeutic agents that reduce deterioration of the analyte indicator.

2. The sensor of claim 1, wherein the sensor is implantable within a living animal.

3. The sensor of claim 1, further comprising at least one drug eluting polymer matrix, wherein the one or more therapeutic agents are dispersed within the drug eluting polymer matrix.

4. The sensor of claim 3, wherein the drug eluting polymer matrix covers at least a portion of the sensor housing.

5. The sensor of claim 3, wherein the drug eluting polymer matrix is applied to the sensor housing via dip coating or spray coating.

6. The sensor of claim 3, wherein one or more of the therapeutic agents are incorporated within the drug eluting polymer matrix via one or more covalent bonds that break in the presence of aqueous media and release the one or more therapeutic agents.

7. The sensor of claim 3, wherein one or more of the therapeutic agents are incorporated within the drug eluting polymer matrix via one or more covalent bonds that break through exposure to light and release the one or more therapeutic agents.

8. The sensor of claim 7, further comprising a light source, wherein the covalent bonds break through exposure to light emitted by the light source.

9. The sensor of claim 3, wherein the drug eluting polymer matrix has a preformed shape.

10. The sensor of claim 9, wherein the preformed shape is a ring.

11. The sensor of claim 9, wherein the preformed shape is a sleeve.

12. The sensor of claim 9, wherein the preformed shape is a conformal shell.

13. The sensor of claim 9, wherein the preformed shape is a cylinder

14. The sensor of claim 9, wherein the preformed shape is a monolith.

15. The sensor of claim 14, wherein the monolith is a rectangular monolith.

16. The sensor of claim 3, wherein the drug eluting polymer matrix is adjacent to the analyte indicator.

17. The sensor of claim 3, wherein the analyte indicator has a first side and a second side, and wherein the drug eluting polymer matrix is located adjacent to the analyte indicator on the first side and the second side of the analyte indicator.

18. The sensor of claim 3, wherein the drug eluting polymer matrix is within the sensor housing.

19. The sensor of claim 18, wherein the sensor housing is perforated to allow elution of the one or more therapeutic agents.

20. The sensor of claim 18, wherein the drug eluting polymer matrix is within a hole, opening, groove or channel in the sensor housing and wherein the sensor housing has an exposed face to allow the elution of the one or more therapeutic agents.

21. The sensor of claim 1, wherein the analyte indicator is located in a polymer matrix.

22. The sensor of claim 21, wherein the one or more therapeutic agents are incorporated in the analyte indicator polymer matrix.

23. The sensor of claim 1, wherein the one or more therapeutic agents include an anti-inflammatory drug.

24. The sensor of claim 23, wherein the anti-inflammatory drug is a non-steroidal anti-inflammatory drug.

25. The sensor of claim 24, wherein the non-steroidal anti-inflammatory drug is acetylsalicylic acid.

26. The sensor of claim 24, wherein the non-steroidal anti-inflammatory drug is isobutylphenylpropanoic acid.

27. The sensor of claim 1, wherein the one or more therapeutic agents include a glucocorticoid.

28. The sensor of claim 1, wherein the one or more therapeutic agents include one or more of dexamethasone, triamcinolone, betamethasone, methylprednisolone, beclometasone, fludrocortisone, derivatives thereof, and analogs thereof.

29. The sensor of claim 1, wherein the one or more therapeutic agents reduce oxidation of the analyte indicator.

30. The sensor of claim 1, wherein the analyte indicator is a graft including indicator molecules.

31. The sensor of claim 1, further comprising a layer of a catalyst capable of converting hydrogen peroxide into water and oxygen on at least a portion of the analyte indicator.

32. The sensor of claim 1, further comprising a membrane covering at least a portion of the analyte indicator.

33. The sensor of claim 32, wherein the membrane is a porous, opaque diffusion membrane.

34. The sensor of claim 32, wherein the membrane is configured to:

substantially prevent white blood cells from passing through the membrane,

permit an analyte of interest to pass through the membrane to the graft, and

substantially prevent transmission of light of at least a specified wavelength or range of wavelengths through the membrane.

35. The sensor of claim 32, wherein the one or more therapeutic agents are incorporated within the membrane.

36. The sensor of claim 35, wherein one or more of the therapeutic agents are incorporated within the membrane via one or more covalent bonds that break in the presence of an aqueous media and release the one or more therapeutic agents.

37. The sensor of claim 35, wherein one or more of the therapeutic agents are incorporated within the membrane via one or more covalent bonds that break through exposure to light and release the one or more therapeutic agents.

38. The sensor of claim 37, further comprising a light source, wherein the covalent bonds break through exposure to light emitted by the light source.

39. The sensor of claim 38, where in light is UV or visible light.

40. The sensor of claim 1, further comprising a first drug eluting polymer matrix and a second drug eluting polymer matrix, wherein the one or more therapeutic agents are dispersed within the first drug eluting polymer matrix, and one or more therapeutic agents are dispersed within the second drug eluting polymer matrix.

41. The sensor of claim 40, wherein the first drug eluting polymer matrix releases the one or more therapeutic agents dispersed within the first drug eluting polymer matrix at a first rate, and the second drug eluting polymer matrix releases the one or more therapeutic agents dispersed within the second drug eluting polymer matrix at a second rate that is different from the first rate.

42. A sensor for measurement of an analyte in a medium within a living animal, the sensor comprising:

a sensor housing;

an analyte indicator covering at least a portion of the sensor housing;

a layer of a catalyst that facilitates the conversion of hydrogen peroxide into water and oxygen on at least a portion of the analyte indicator; and

at least one drug eluting polymer matrix dispersed within the drug eluting polymer matrix, wherein the one or more therapeutic agents reduce deterioration of the analyte indicator.

43. The sensor of claim 42, wherein the drug eluting polymer matrix covers at least a portion of the sensor housing.

44. The sensor of claim 42, wherein the drug eluting polymer matrix is within the sensor housing, and the sensor housing is perforated to allow elution of the one or more therapeutic agents.

45. The sensor of claim 42, wherein one or more therapeutic agents that reduce deterioration of the analyte indicator are incorporated within the analyte indicator.

46. The sensor of claim 42, further comprising a membrane covering at least a portion of the analyte indicator.

47. The sensor of claim 46, wherein one or more therapeutic agents that reduce deterioration of the analyte indicator are incorporated within the membrane.