Method and system for sterilizing an analyte sensor

• US 8,802,006 B2
• Filed: 08/27/2012
• Issued: 08/12/2014
• Est. Priority Date: 04/10/2008
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Thomas, Christopher Allen, Zhao, Jasmin Y.
• Primary Examiner(s): Chorbaji, Monzer R
• Application Number:
  US13/595,673
• Publication Number:
  US 20120328473A1
• Time in Patent Office: 715 Days
• Field of Search: 422/1, 422/22, 250/453.11, 250/492.1, 600/347, 600/365, 600/133, 435/4, 435/173.1
• US Class Current: 422/22
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 50/39 the containers containing antimicrobial, antiviral or disinfectant agents
• CPC Class Codes: A61B 90/70 Cleaning devices specially adapted for surgical instruments
• CPC Class Codes: A61L 2/08 Radiation
• CPC Class Codes: A61L 2/087 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61L 2/20 Gaseous substances, e.g. vapours
• CPC Class Codes: A61L 2/206 Ethylene oxide
• CPC Class Codes: A61L 2202/14 Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: A61M 5/003 Kits for diabetics
• CPC Class Codes: B65B 5/04 Packaging single articles
• CPC Class Codes: B65B 55/08 by irradiation
• CPC Class Codes: B65B 55/10 by liquids or gases
• CPC Class Codes: B65B 55/16 by irradiation
• CPC Class Codes: B65B 55/18 by liquids or gases B65B55/14 takes precedence
• CPC Class Codes: B65B 7/16 : Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
• CPC Class Codes: B65D 65/38 : Packaging materials of special type or form
• CPC Class Codes: B65D 77/26 : Elements or devices for locating or protecting articles

Abstract

In one aspect, there is provided assembling an analyte sensor with an analyte sensor insertion device, packaging the assembled analyte sensor and sensor insertion device in a substantially airtight seal, and irradiating the packaged assembled analyte sensor and sensor insertion device at a predetermined dose using one or more electron beam accelerators.

Claims

1. A method of sterilizing a glucose monitoring assembly, the method comprising:

assembling a glucose sensor and a sensor introducer to form a glucose sensor assembly, wherein the glucose sensor comprises at least one electrode, an enzyme layer, and a glucose diffusion limiting layer;

assembling a medical device assembly including sensor electronics;

packaging the glucose sensor assembly in a first container;

packaging the first container in a second container that includes at least one glucose sensor assembly;

irradiating the second container including the at least one glucose sensor assembly at a predetermined dose level using electron beam irradiation; and

exposing the medical device unit assembly to a chemical solution for a second predetermined time period to sterilize the medical device assembly.

2. The method of claim 1, wherein the chemical solution is a gaseous solution.

3. The method of claim 2, wherein the gaseous solution includes one of ethylene oxide, vaporized hydrogen peroxide, and nitrogen oxide.

4. The method of claim 1, further comprising sealing the first container with a cover, wherein the first container includes thermoformed plastic.

5. The method of claim 4, wherein the cover includes aluminum.

6. The method of claim 4, wherein the cover and the first container form the seal with an adhesive material disposed therebetween.

7. The method of claim 1, wherein the packaged glucose sensor assembly is irradiated at a surface dosage of between 25 kGy and 60 kGy.

8. The method of claim 1, wherein the irradiation of the packaged glucose sensor assembly and the exposure of the medical device assembly to the chemical solution results in a 10⁻

6 sterility assurance level for both of the assemblies.

9. The method of claim 1, wherein both the packaged glucose sensor assembly and the medical device assembly are sterilized to maintain a predetermined sterility level for at least six months.

10. The method of claim 1, wherein both the packaged glucose sensor assembly and the medical device assembly are sterilized to maintain a predetermined sterility level for at least 18 months.

11. The method of claim 1, wherein the enzyme layer comprises a mediator.

12. The method of claim 11, wherein the enzyme layer comprises a redox polymer.

13. The method of claim 11, wherein the redox polymer comprises an osmium-containing polymer.

14. The method of claim 1, wherein the glucose diffusion limiting layer comprises a polymer.

15. The method of claim 1, wherein the glucose sensor comprises a planar substrate on which the at least one electrode is positioned.

16. The method of claim 1, wherein the packaged glucose sensor assembly is irradiated using at least one electron beam accelerator.

17. The method of claim 1, wherein the medical device assembly is exposed to the chemical solution in an environment with a predetermined temperature.

18. The method of claim 17, wherein the environment has a predetermined humidity.

19. The method of claim 18, wherein the second predetermined time period is determined based on at least one of the predetermined temperature and the predetermined humidity of the environment, and wherein the chemical solution has a predetermined concentration.

20. The method of claim 1, further comprising packaging the medical device assembly and the glucose sensor assembly in a kit.

21. The method of claim 1, wherein the medical device assembly includes a sensor delivery unit.

22. The method of claim 1, wherein the medical device assembly includes an adhesive for adhering the sensor electronics assembly to a skin surface.

23. The method of claim 1, wherein the glucose sensor assembly includes a desiccant.

24. A method of sterilizing a glucose monitoring assembly, the method comprising:

assembling a glucose sensor and a sensor introducer to form a glucose sensor assembly, wherein the glucose sensor comprises at least one electrode, an enzyme layer, and a glucose diffusion limiting layer;

packaging the glucose sensor assembly in a first container;

packaging the first container in a second container that includes at least one glucose sensor assembly; and

irradiating the second container including the at least one glucose sensor assembly at a predetermined dose level using electron beam irradiation.

25. The method of claim 24, wherein packaging the glucose sensor assembly in the first container includes sealing the first container including thermoformed plastic with a cover.

26. The method of claim 25, wherein the cover includes foil.

27. The method of claim 25, wherein the cover and the first container form a seal with an adhesive material disposed therebetween.

28. The method of claim 24, wherein irradiating the second container includes irradiating at a surface dosage of between 25 kGy and 60 kGy.

29. The method of claim 24, wherein irradiating the second container including a predetermined number of glucose sensor assemblies results in a 10⁻

6 sterility assurance level.

30. The method of claim 24, wherein the packaged glucose sensor assembly is sterilized to maintain a predetermined sterility level for at least six months.

31. The method of claim 24, wherein the packaged glucose sensor assembly is sterilized to maintain a predetermined sterility level for at least 18 months.

32. The method of claim 24, wherein the enzyme layer comprises a mediator.

33. The method of claim 32, wherein the enzyme layer comprises a redox polymer.

34. The method of claim 33, wherein the redox polymer comprises an osmium-containing polymer.

35. The method of claim 24, wherein the glucose diffusion limiting layer comprises a polymer.

36. The method of claim 24, wherein the packaged glucose sensor assembly is irradiated using an electron beam accelerator.

37. The method of claim 24, wherein the glucose sensor assembly includes a desiccant.

38. The method of claim 24, further comprising:

assembling a medical device assembly including sensor electronics; and

packaging the sterilized glucose sensor assembly with the medical device assembly.

39. The method of claim 38, wherein the medical device assembly includes a sensor delivery unit.