Method and System for Sterilizing an Analyte Sensor

• US 20090257911A1
• Filed: 04/10/2009
• Published: 10/15/2009
• 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: Zhao, Jasmin Y., Thomas, Christopher Allen
• Granted Patent: US 8,252,229 B2
• Time in Patent Office: Days
• 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 sensor, the method comprising:

assembling a glucose sensor with a sensor mounting unit and a sensor delivery unit, where the glucose sensor comprises at least one electrode, an enzyme area, and a glucose diffusion limiting area, the sensor delivery unit comprises a housing and a metal sharp, and the sensor mounting unit comprises an adhesive; and

irradiating the assembly with a predetermined dose level and/or for a predetermined time period to sterilize the assembly.

2. The method of claim 1, comprising positioning the assembly in a container and sealing the assembly in the container with a cover.

3. The method of claim 2 wherein the container includes thermoformed plastic.

4. The method of claim 2 wherein the cover includes aluminum.

5. The method of claim 2 wherein the cover and the container form the seal with an adhesive material disposed therebetween.

6. The method of claim 1 wherein the assembly is irradiated at a surface dosage of between approximately 25 kGy and 60 kGy.

7. The method of claim 1 wherein the irradiation of the packaged assembled analyte sensor and sensor insertion device results in about 10⁻

6 sterility assurance level.

8. The method of claim 1 wherein the assembly is sterilized to maintain a predetermined sterility level for at least about six months.

9. The method of claim 1 wherein the assembly is sterilized to maintain a predetermined sterility level for at least about 18 months.

10. The method of claim 1 wherein the enzyme area comprises a mediator.

11. The method of claim 10, wherein the enzyme area comprises a redox polymer.

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

13. The method of claim 1 wherein the glucose diffusion limiting area comprises a polymer.

14. The method of claim 1 wherein the sensor comprises a substantially planar substrate on which the at lest one electrode is positioned.

15. A method of sensor delivery assembly sterilization, comprising:

assembling an analyte sensor with an analyte sensor insertion device;

packaging the assembled analyte sensor and sensor insertion device in a container; and

irradiating the container including packaged assembled analyte sensor and sensor insertion device at a predetermined dose using one or more electron beam accelerators.

16. The method of claim 15, wherein the predetermined dose is approximately 30 kGy.

17. The method of claim 15, wherein the packaged assembled analyte sensor and sensor insertion device are irradiated at a surface dosage of between approximately 25 kGy and 60 kGy.

18. The method of claim 15, wherein the irradiation of the packaged assembled analyte sensor and sensor insertion device produces about 10⁻

6 sterility assurance level.

19. The method of claim 15, wherein the packaged assembled analyte sensor and sensor insertion device are irradiated from two opposing sides using at least two electron beam accelerators.

20. The method of claim 19, wherein a respective time period associated with the irradiation of the packaged assembled analyte sensor and sensor insertion device from each of the at least two electron beam accelerators are substantially non-overlapping.

21. The method of claim 19, wherein the irradiation of the packaged assembled analyte sensor and sensor insertion device produces about 10⁻

6 sterility assurance level.

22. The method of claim 15, wherein the packaged assembled analyte sensor and sensor insertion device is sterilized with one electron beam accelerator.

23. The method of claim 22 including rotating the packaged assembled analyte sensor and sensor insertion device during irradiation to expose the maximum surface of the packaged assembled analyte sensor and sensor insertion device substantially perpendicular to the electron beam irradiation.

24. The method of claim 22, wherein the irradiation of the packaged assembled analyte sensor and sensor insertion device produces about 10⁻

6 sterility assurance level.

25. The method of claim 15, including providing an indication of sterilization status on the irradiated packaged assembled analyte sensor and sensor insertion device.

26. The method of claim 15, wherein assembling the analyte sensor with the analyte sensor insertion device includes coupling the analyte sensor to the analyte sensor insertion device.

27. The method of claim 26 wherein coupling includes decoupleably coupling the analyte sensor to a predetermined portion of the analyte sensor insertion device.

28. A system for sterilizing an analyte sensor insertion device assembly, comprising:

a container including an inner cavity and a seal, the container including an analyte sensor insertion device assembly positioned substantially within the inner cavity, wherein the seal is provided entirely over the cavity on the container; and

an electron beam accelerator configured to irradiate the container at a predetermined dose.

29. The system of claim 28, wherein the predetermined dose is at least approximately 30 kGy.

30. The system of claim 28, wherein electron beam accelerator is configured to irradiate the packaging at a surface dosage of between approximately 25 kGy and 60 kGy.

31. The system of claim 28, wherein the electron beam accelerator irradiation of the packaging results in approximately 10⁻

6 sterility assurance level.

32. The system of claim 28 wherein the packaging includes a sterilization status indicator.

33. The system of claim 28 wherein the analyte sensor includes a glucose sensor.

34. A method, comprising:

exposing a packaged assembly including an analyte sensor and sensor insertion device to electron beam irradiation to result in approximately 10<sup>−

6</sup> sterility assurance level.