Membranes for an analyte sensor

• US 20070173709A1
• Filed: 01/17/2007
• Published: 07/26/2007
• Est. Priority Date: 04/08/2005
• Status: Abandoned Application

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Campbell, Rebecca, Tran, Olivia, Nicholas, Melissa, Petisce, James, Woo, Kum
• Application Number:
  US11/654,140
• Publication Number:
  US 20070173709A1
• Time in Patent Office: Days
• US Class Current: 600/345
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 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 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: C12Q 1/002 Electrode membranes
• CPC Class Codes: C12Q 1/003 Functionalisation

Abstract

The present invention relates generally to devices for measuring an analyte in a host. More particularly, the present invention relates to devices for measurement of glucose in a host that incorporate a hydrophilic electrode domain and/or a cellulosic-based interference domain.

Claims

1. An electrochemical analyte sensor configured for implantation in vivo and for measuring an analyte concentration in a host, the sensor comprising:

at least one electroactive surface; and

a membrane system disposed on the electroactive surface, wherein the membrane system comprises an electrode domain, wherein the electrode domain is adjacent to the electroactive surface, and wherein the sensor is configured to break in, in vivo, in less than about 2 hours.

2. The sensor of claim 1, wherein the sensor is configured to break in, in vivo, in less than about 1 hour.

3. The sensor of claim 1, wherein the sensor is configured to break in, in vivo, in less than about 20 minutes.

4. The sensor of claim 1, wherein the sensor is configured to break in, in vivo, substantially immediately.

5. The sensor of claim 1, wherein the electrode domain is substantially more hydrophilic than an adjacent domain that is more distal to the electroactive surface than the electrode domain.

6. The sensor of claim 5, wherein the electrode domain absorbs at least about 5 wt. % more water than the adjacent domain during membrane equilibration.

7. The sensor of claim 5, wherein the electrode domain absorbs at least about 20 wt. % more water than the adjacent domain during membrane equilibration.

8. The sensor of claim 1, wherein the electrode domain comprises a single hydrophilic polymer.

9. The sensor of claim 1, wherein the electrode domain comprises at least one layer comprising at least one hydrophilic polymer.

10. The sensor of claim 1, wherein the electrode domain comprises at least two layers, each layer comprising at least one hydrophilic polymer.

11. The sensor of claim 1, wherein the electrode domain comprises a hydrophilic polymer selected from the group consisting of a polyamide, a polylactone, a polyimide, a polylactam, a functionalized polyamide, a functionalized polylactone, a functionalized polyimide, a functionalized polylactam, and copolymers thereof.

12. The sensor of claim 1, wherein the electrode domain comprises a hydrophilic polymer selected from the group consisting of poly-N-vinylpyrrolidone, poly-N-vinyl-2-piperidone, poly-N-vinyl-2-caprolactam, poly-N-vinyl-3-methyl-2-caprolactam, poly-N-vinyl-3-methyl-2-piperidone, poly-N-vinyl-4-methyl-2-piperidone, poly-N-vinyl-4-methyl-2-caprolactam, poly-N-vinyl-3-ethyl-2-pyrrolidone, poly-N-vinyl-4,5-dimethyl-2-pyrrolidone, polyvinylimidazole, poly-N,N-dimethylacrylamide, polyvinyl alcohol, polyacrylic acid, polyethylene oxide, poly-2-ethyl-oxazoline, and copolymers thereof.

13. The sensor of claim 1, wherein the electrode domain comprises poly-N-vinylpyrrolidone.

14. The sensor of claim 1, further comprising sensor electronics operably connected to the electrode and configured to provide a signal representative of an analyte concentration in the host, wherein the analyte is glucose, wherein the membrane system comprises at least one additional domain, wherein the electrode domain is more proximal to the electroactive surface than the additional domain, wherein the additional domain comprises an interference domain configured to substantially block passage therethrough of at least one interferent;

and wherein an equivalent glucose signal response of the interferent is less than about 60 mg/dl.

15. The sensor of claim 14, wherein the interferent is selected from the group consisting of acetaminophen, ascorbic acid, dopamine, ibuprofen, salicylic acid, tolbutamide, tetracycline, creatinine, uric acid, ephedrine, L-dopa, methyl dopa and tolazamide.

16. The sensor of claim 14, wherein the equivalent glucose signal response of the interferent is less than about 40 mg/dL.

17. The sensor of claim 14, wherein the equivalent glucose signal response of the interferent is less than about 20 mg/dL.

18. The sensor of claim 14, wherein the interferent is acetaminophen and the equivalent glucose signal response of the acetaminophen is about 20 mg/dL or less.

19. The sensor of claim 14, wherein the interference domain comprises at least one cellulosic derivative.

20. The sensor of claim 19, wherein the cellulosic derivative is cellulose acetate.

21. The sensor of claim 19, wherein the cellulosic derivative is cellulose acetate butyrate.

22. The sensor of claim 19, wherein the cellulosic derivative comprises a blend of cellulose acetate and cellulose acetate butyrate.

23. An electrochemical analyte sensor configured for implantation in vivo and for measuring an analyte concentration in a host, the sensor comprising:

at least one electroactive surface; and

a membrane system disposed on the electroactive surface, wherein the membrane system comprises a uni-component hydrophilic domain, wherein the hydrophilic domain is adjacent to the electroactive surface.

24. The sensor of claim 23, wherein the uni-component hydrophilic domain is not crosslinked.

25. The sensor of claim 23, wherein the uni-component hydrophilic domain is crosslinked.

26. The sensor of claim 23, wherein the uni-component hydrophilic domain comprises a material selected from the group consisting of polyamides, polylactones, polyimides, polylactams, functionalized polyamides, functionalized polylactones, functionalized polyimides, functionalized polylactams, and copolymers thereof.

27. The sensor of claim 23, wherein the uni-component hydrophilic domain comprises a hydrophilic polymer selected from the group consisting of poly-N-vinylpyrrolidone, poly-N-vinyl-2-piperidone, poly-N-vinyl-2-caprolactam, poly-N-vinyl-3-methyl-2-caprolactam, poly-N-vinyl-3-methyl-2-piperidone, poly-N-vinyl-4-methyl-2-piperidone, poly-N-vinyl-4-methyl-2-caprolactam, poly-N-vinyl-3-ethyl-2-pyrrolidone, poly-N-vinyl-4,5-dimethyl-2-pyrrolidone, polyvinylimidazole, poly-N,N-dimethylacrylamide, polyvinyl alcohol, polyacrylic acid, polyethylene oxide, poly-2-ethyl-oxazoline, and copolymers thereof.

28. The sensor of claim 23, wherein the uni-component hydrophilic domain comprises poly-N-vinylpyrrolidone.

29. The sensor of claim 23, wherein the sensor is configured to break in, in vivo, in less than about 2 hours.

30. A method of using an analyte sensor configured for in vivo implantation in a host, comprising:

implanting an analyte sensor in a host;

allowing the sensor to break-in in vivo; and

measuring a signal representative of a concentration of an analyte in the host, wherein the step of measuring is capable of being performed with substantial accuracy less than about 2 hours after the step of implanting.

31. The method of claim 30, wherein the step of measuring is capable of being performed with substantial accuracy less than about 1 hour after the step of implanting.

32. The method of claim 30, wherein the step of measuring is capable of being performed with substantial accuracy less than about 20 minutes after the step of implanting.

33. The method of claim 30, wherein the step of measuring is capable of being performed with substantial accuracy substantially immediately after the step of implanting.

34. The method of claim 30, wherein the analyte sensor comprises an electroactive surface and a membrane system comprising a hydrophilic electrode domain, wherein the step of allowing the sensor to break in further comprises the step of allowing the membrane system to equilibrate to a surrounding physiological environment.

35. The method of claim 34, wherein the step of allowing the membrane system to equilibrate comprises absorption of more water by the electrode domain than by an adjacent domain that is more distal to the electroactive surface than the electrode domain.

36. The method of claim 35, wherein the electrode domain absorbs at least about 5 wt. % more water than the adjacent domain.

37. The method of claim 35, wherein the electrode domain absorbs at least about 20 wt. % more water than the adjacent domain.

38. The method of claim 30, wherein the step of implanting the analyte sensor in the host comprises inserting the sensor into a subcutaneous tissue through a skin.

39. The method of claim 30, wherein the step of implanting the analyte sensor in the host comprises inserting the sensor into a vascular system of the host or into an extracorporeal device connected to a circulatory system of the host.