Opacity consistent polymer graft for optical sensor

• US 9,498,156 B2
• Filed: 05/16/2014
• Issued: 11/22/2016
• Est. Priority Date: 05/17/2013
• Status: Active Grant

• Current Assignee: Senseonics, Incorporated (Senseonics Holdings, Inc.)
• Original Assignee: Senseonics, Incorporated (Senseonics Holdings, Inc.)
• Inventors: Whitehurst, Todd, Huffstetler, Philip
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US14/279,759
• Publication Number:
  US 20140343381A1
• Time in Patent Office: 921 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/162 Capsule shaped sensor housings, e.g. for swallowing or implantation
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence

Abstract

A sensor (e.g., an optical sensor) that may be placed 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) within the animal. The sensor may include a sensor housing and a polymer graft including indicator molecules and covering at least a portion of the sensor housing. The opacity of the polymer graft may remain substantially the same (i.e., may have little or no variation) over time. The sensor may include a photodetector, and variation in the opacity of the polymer graft does not cause a significant change in a measurement signal output by the photodetector. The polymer hydrogel may be made of polymers including acrylic acid and/or polyethylene glycol.

Claims

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

a sensor housing; and

a polymer graft including indicator molecules and covering at least a portion of the sensor housing;

wherein the polymer graft is clear, and the opacity of the graft remains the same over time.

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

a sensor housing; and

a polymer graft including indicator molecules and covering at least a portion of the sensor housing, wherein the polymer graft is clear, configured to pass a percentage of light and configured such that the percentage of light passing through the polymer graft would not change by more than 50% if the sensor were placed within the living animal for at least one month.

3. The sensor of claim 2, wherein the percentage of light passing through the polymer graft would not change by more than 20% if the sensor were placed within the living animal for at least one month.

4. The sensor of claim 3, wherein the percentage of light passing through the polymer graft would not change by more than 10% if the sensor were placed within the living animal for at least one month.

5. The sensor of claim 2, wherein the percentage of light passing through the polymer graft would not change by more than 50% if the sensor were placed within the living animal for at least two months.

6. The sensor of claim 2, wherein the percentage of light passing through the polymer graft would not change by more than 50% if the sensor were placed within the living animal for at least six months.

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

a sensor housing; and

a polymer graft including indicator molecules, said polymer graft covering at least a portion of the sensor housing;

a light source configured to emit excitation light to the indicator molecules of the polymer graft;

a photodetector configured to receive emission light from the indicator molecules of the polymer graft and output a measurement signal indicative of the amount of the received emission light, wherein the amount of the emission light received by the photodetector is indicative of the amount of the analyte in the medium within the living animal;

wherein the polymer graft is clear and configured such that variation of the opacity of the polymer graft during measurement of the analye in the medium within the living animal causes a change, which is unrelated to the amount of analyte in the medium, in the measurement signal of 20% or less.

8. The sensor of claim 7, wherein the change in the measurement signal caused by the variation of the opacity of the polymer graft is 10% or less.

9. The sensor of claim 8, wherein the change in the measurement signal caused by the variation of the opacity of the polymer graft is 5% or less.

10. The sensor of claim 9, wherein the change in the measurement signal caused by the variation of the opacity of the polymer graft is 2% or less.

11. The sensor of claim 10, wherein the change in the measurement signal caused by the variation of the opacity of the polymer graft is 1% or less.

12. The sensor of claim 7, wherein the polymer graft has an analyte response time less than 15 minutes.

13. The sensor of claim 12, wherein the polymer graft has an analyte response time less than 10 minutes.

14. The sensor of claim 13, wherein the polymer graft has an analyte response time less than 5 minutes.

15. The sensor of claim 7, wherein the polymer graft is made of a polymer hydrogel including acrylic acid.

16. The sensor of claim 15, wherein the polymer hydrogel includes polyethylene glycol monomers.

17. The sensor of claim 7, wherein the polymer graft is made of a polymer hydrogel including polyethylene glycol monomers.

18. The sensor of claim 7, further comprising a layer of platinum on an outside surface of the polymer graft.

19. The sensor of claim 18, wherein the platinum layer is sputtered on the polymer graft.

20. The sensor of claim 18, further comprising an opaque analyte permeable membrane over at least a portion of the polymer graft and the platinum layer, wherein the opaque analyte permeable membrane is configured to (i) block light from passing beyond the polymer graft and the platinum layer and (ii) channel the analyte to the graft.

21. The sensor of claim 7, further comprising an opaque analyte permeable membrane over at least a portion of the polymer graft.

22. The sensor of claim 21, wherein the opaque analyte permeable membrane is configured to (i) block light from passing beyond the polymer graft and (ii) channel the analyte to the graft.

23. The sensor of claim 21, wherein the opaque analyte permeable membrane is hydrophilic.

24. The sensor of claim 21, wherein the opaque analyte permeable membrane is a hydrophobic material that is functionalized to be hydrophilic.

25. The sensor of claim 21, wherein the opaque analyte permeable membrane is a hydrophilic nylon membrane.

26. The sensor of claim 21, wherein the opaque analyte permeable membrane is porous polyethylene terephthalate (PET) membrane.

27. The sensor of claim 7, wherein the living animal is a human.

28. The sensor of claim 7, wherein the medium is interstitial fluid.

29. The sensor of claim 7, wherein the analyte is glucose.

30. The sensor of claim 7, wherein the analyte is oxygen.

31. The sensor of claim 7, wherein the indicator molecules are fluorescent indicator molecules.