Sterile device and method for producing same

• US 8,133,435 B2
• Filed: 12/31/2004
• Issued: 03/13/2012
• Est. Priority Date: 10/23/2001
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Reynolds, Jennifer M., Swanson, Aaron, Shah, Rajiv
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): Chorbaji, Monzer
• Application Number:
  US11/026,678
• Publication Number:
  US 20050158205A1
• Time in Patent Office: 2,629 Days
• Field of Search: 422/56, 422/82.01, 422/98, 422/1, 422/6, 422/22, 422/2, 422/4, 422/121, 422/186, 422/292, 422/186.05, 422/300, 422/305, 422/905, 427/74, 427/282, 623 24- 26, 534/25, 534/31, 206/524.1, 607/6
• US Class Current: 422/22
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61L 2/08 Radiation
• CPC Class Codes: A61L 2/18 Liquid substances or solutions comprising solids or dissolved gases
• CPC Class Codes: A61L 2/206 Ethylene oxide
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: Y10S 422/905 Miscellaneous liquid sterilization means

Abstract

A sterile device immersed in a sterile buffer and a method for providing same. The sterile device may be a medical device such as a biosensor having a biomolecule as a sensing element such as, for example, a glucose oxidase enzyme. The buffer may be a bicarbonate solution. Both the device and the buffer may be packaged and stored over long term while maintaining sterilization. The sterilization method may comprise a combination of gaseous, liquid and light sterilization.

Claims

1. A sterile apparatus comprising:

a sterile device for use in a sterile application, the sterile device comprising a biomolecule; and

a package that encloses the sterile device, the package comprising a material that allows light of a wavelength of between about 200 nm and about 1000 nm to pass through the package to shine on the sterile device enclosed within the package;

wherein the sterile device has been sterilized in the package to a desired level of sterilization by light of a wavelength of between about 200 nm and about 1000 nm.

2. The apparatus of claim 1, wherein the sterile device is a medical device.

3. The apparatus of claim 1, wherein the sterile device is a sensor.

4. The apparatus of claim 1, wherein the sterile device further comprises a hydrated element.

5. The apparatus of claim 1, wherein the sterile device is implantable.

6. The apparatus of claim 1, wherein the package is transparent.

7. The apparatus of claim 1, wherein the package is translucent.

8. The apparatus of claim 1, wherein the package is optically transmissive.

9. The apparatus of claim 1, further comprising a sterile buffer for hydration, wherein the sterile device, sterile buffer and package have been sterilized using light.

10. The apparatus of claim 1, the sterile device comprising sterile electronics in a substantially liquid impervious housing, wherein the sterile electronics comprises a gas-sterilized device.

11. The apparatus of claim 10, wherein the sterile device further comprises a liquid-sterilized biomolecule.

12. The apparatus of claim 1, the sterile device comprising sterile electronics in a substantially liquid impervious housing, wherein the biomolecule is operatively coupled to the sterile electronics.

13. The apparatus of claim 12, wherein the biomolecule is glucose oxidase.

14. The apparatus of claim 12,

wherein, when the sterile device is enclosed in the sterile package, the biomolecule is exposed to the sterile buffer for hydration.

15. The apparatus of claim 1, the sterile device comprising sterile electronics in a substantially liquid impervious housing, wherein the sterile electronics comprise an integrated circuit.

16. The apparatus of claim 15,

wherein the sterile device comprises a substrate;

and

wherein the sterile electronics are supported on the substrate.

17. The apparatus of claim 1, the sterile device comprising sterile electronics in a substantially liquid impervious housing, wherein the sterile electronics comprise circuitry for performing signal processing.

18. The apparatus of claim 1, the sterile device comprising sterile electronics in a substantially liquid impervious housing.

19. The apparatus of claim 1, further comprising a sterile buffer for hydration, wherein:

the sterile device is immersed in a buffer;

the sterile package encloses the buffer with the sterile device;

the material of the sterile package allows the light of a wavelength of between about 200 nm and about 1000 nm to shine on the buffer with the sterile device;

at least one of the sterile device and the buffer is sterilized in the sterile package to a desired level of sterilization by light of a wavelength of between about 200 nm and about 1000 nm.

20. The apparatus of claim 1, wherein the sterile device has sterilized to the desired level of sterilization by a plurality of lamps that flash at least three times.

21. A method for sterilizing an apparatus, comprising:

providing an apparatus having a biomolecule;

enclosing the apparatus in a package, the package comprising a material that allows light of a wavelength of between about 200 nm and about 1000 nm to pass through the package to shine on the apparatus enclosed within the package; and

sterilizing the apparatus enclosed in the package to a desired level of sterilization by shining light of a wavelength of between about 200 nm and about 1000 nm through the sterile package and onto the apparatus enclosed within the package.

22. The method of claim 21, further comprising

sterilizing the apparatus in a gas;

and

sterilizing the apparatus in a liquid.

23. The method of claim 22, wherein sterilizing the apparatus in a gas comprises sterilizing the apparatus in ethylene oxide.

24. The method of claim 22, wherein sterilizing the apparatus in a liquid comprises sterilizing the apparatus in glutaraldehyde.

25. The method of claim 21, wherein sterilizing the apparatus enclosed in the package comprises shining a broad spectrum pulse light through the package and onto the apparatus enclosed within the package.

26. The method of claim 21, further comprising enclosing electronics in a substantially liquid impervious housing, placing the apparatus with the electronics in a buffer comprising a bicarbonate solution.

27. The method of claim 21, wherein the apparatus further includes a biosensor.

28. The method of claim 21, wherein the biomolecule comprises a glucose oxidase enzyme.

29. The method of claim 21, further comprising enclosing electronics in a substantially liquid impervious housing, wherein placing the apparatus in a buffer comprises placing the apparatus with the electronics in a buffer.

30. A sterile apparatus comprising:

a package;

a buffer for hydration; and

a sterile device for use in a sterile application, the sterile device comprising a liquid sterilized biomolecule subsequent to, comprising a gas sterilized electronics, the sterile device being immersed in the buffer,

wherein the package encloses the sterile device and the buffer, the package comprising a material that allows light of a wavelength of between about 200 nm and about 1000 nm to pass through the package to shine on the sterile device and the buffer enclosed within the package;

wherein the sterile device has been sterilized in the package to a desired level of sterilization by light of a wavelength of between about 200 nm and about 1000 nm.

31. The apparatus of claim 30, wherein the sterile device is a medical device.

32. The apparatus of claim 30, wherein the sterile device is a sensor.

33. The apparatus of claim 30, wherein the sterile device comprising sterile electronics includes an integrated circuit.