Glucose sensor package system

• US 6,520,326 B2
• Filed: 10/09/2001
• Issued: 02/18/2003
• Est. Priority Date: 02/25/1999
• Status: Expired due to Term

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Halili, Edgardo C., Branch, Kevin D., Cabernoch, James L., McIvor, K. Collin, Mastrototaro, John J., Van Antwerp, Nannette M.
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): Natnithithadha, Navin
• Application Number:
  US09/973,852
• Publication Number:
  US 20020023852A1
• Time in Patent Office: 497 Days
• Field of Search: 600/345, 600/347, 600/357, 600/309, 600/365, 206/305, 206/306, 206/363, 206/438, 206/459.1, 204/403, 204/411, 204/412, 422/1, 422/22
• US Class Current: 206/305
• 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 5/6849 in combination with a needle set

Abstract

A glucose sensor package system that includes a glucose sensor and a protective package that indicates exposure to temperature changes to indicate proper temperature control. Also covered are methods of transporting and sterilizing the package. In addition, glucose sensors directed to various sizing and positioning of the electrodes on the glucose sensor are covered.

Claims

1. A glucose sensor package system for sterilizing a glucose sensor using electron beam sterilization, the system comprising:

at least one glucose sensor;

a protective package having an interior to hold the at least one glucose sensor in the interior of the protective package; and

at least one radiation exposure indicator to determine if the protective package has been exposed to a predetermined exposure level of electron beam sterilization.

2. The glucose sensor package system according to claim 1, wherein the predetermined exposure level is above 2.0 Mrad.

3. The glucose sensor package system according to claim 1, wherein the predetermined exposure level is less than or equal to 5.0 Mrad.

4. The glucose sensor package system according to claim 1, wherein the predetermined temperature is above 0.5 Mrad.

5. The glucose sensor package system according to claim 1 wherein the at least one radiation exposure indicator indicates that the predetermined exposure level existed for a period of time.

6. The glucose sensor package system according to claim 1, wherein the at least one radiation exposure indicator is attached to the protective package.

7. The glucose sensor package system according to claim 6, wherein the at least one radiation exposure indicator is attached to the interior of the protective package.

8. The glucose sensor package system according to claim 6, wherein the at least one radiation exposure indicator is attached to an exterior of the protective package.

9. The glucose sensor package system according to claim 1, wherein the at least one radiation exposure indicator is contained within the protective package.

10. The glucose sensor package system according to claim 1, wherein the at least one radiation exposure indicator is attached to the glucose sensor.

11. The glucose sensor package system according to claim 1, wherein the at least one radiation exposure indicator is a sticker.

12. A method of sterilizing a glucose sensor using electron beam sterilization, the method comprising the steps of:

providing at least one glucose sensor;

providing protective package having an interior;

holding the at least one glucose sensor in the interior of the protective package; and

using at least one radiation exposure indicator to determine if the protective package has been exposed to a predetermined exposure value.

13. The method according to claim 12, wherein the predetermined exposure value is 2 Mrads.

14. The method according to claim 12, wherein the predetermined exposure value is less than or equal to 5 Mrads.

15. The method according to claim 12, wherein the predetermined exposure value is above 0.5 Mrads.

16. The method according to claim 12, further using the at least one radiation exposure indicator to indicate that the predetermined exposure value existed for a period of time.

17. The method according to claim 12, further comprising the step of attaching the at least one radiation exposure indicator to the protective package.

18. The method according to claim 17, further comprising the step of attaching the at least one radiation exposure indicator to the interior of the protective package.

19. The method according to claim 17 further comprising the step of attaching the at least one radiation exposure indicator to an exterior of the protective package.

20. The method according to claim 12, further comprising the step of containing the at least one radiation exposure indicator within the protective package.

21. The method according to claim 12, further comprising the step of attaching the at least one radiation exposure indicator to the glucose sensor.

22. The method according to claim 12, further comprising using the at least one radiation exposure indicator formed as a sticker.