Sterile device and method for producing same

• US 20050158205A1
• Filed: 12/31/2004
• Published: 07/21/2005
• Est. Priority Date: 10/23/2001
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Shah, Rajiv, Reynolds, Jennifer M., Swanson, Aaron J.
• Granted Patent: US 8,133,435 B2
• Time in Patent Office: Days
• 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 buffer for hydration;

a sterile device for use in a sterile application, the sterile device comprising sterile electronics enclosed in a substantially liquid impervious housing, the sterile device being immersed in the sterile buffer; and

a sterile package, wherein the sterile package encloses the sterile device and the sterile buffer.

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 comprise a hydrated element.

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

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

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

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

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

10. The apparatus of claim 1, wherein the sterile electronics comprise a gas-sterilized device.

11. The apparatus of claim 1, wherein the sterile device further comprises a liquid-sterilized device.

12. The apparatus of claim 1, wherein the sterile device further comprises a biomolecule operatively coupled to the sterile electronics.

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

45. The apparatus of claim 1, wherein the sterile electronics comprise an integrated circuit.

46. The apparatus of claim 1,

wherein the sterile device comprises a substrate;

and

wherein the sterile electronics are supported on the substrate.

47. The apparatus of claim 1,

wherein the sterile electronics comprise circuitry for performing signal processing.

48. 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.

14. A method for sterilizing an apparatus having electronics, comprising:

enclosing the electronics in a substantially liquid impervious housing;

placing the apparatus with the electronics in a buffer;

enclosing the apparatus and the buffer in a package; and

sterilizing the package using light.

15. The method of claim 14, further comprising

sterilizing the apparatus in a gas;

and

sterilizing the apparatus in a liquid.

16. The method of claim 14, wherein sterilizing the package using light comprises sterilizing the package using a broad spectrum pulse light.

17. The method of claim 15, wherein sterilizing the apparatus in a gas comprises sterilizing the apparatus in ethylene oxide.

18. The method of claim 15, wherein sterilizing the apparatus in a liquid comprises sterilizing the apparatus in glutaraldehyde.

19. The method of claim 14, wherein placing the apparatus with the electronics in a buffer comprises placing the apparatus in a bicarbonate solution.

20. The method of claim 14, wherein the apparatus further includes a biosensor.

21. The method of claim 20, wherein the biosensor comprises a biomolecule.

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

23. A sterile apparatus comprising:

a sterile package;

a sterile buffer for hydration; and

a sterile device for use in a sterile application, the sterile device comprising sterile electronics, the sterile electronics comprising an integrated circuit, the sterile device being immersed in the sterile buffer;

wherein the sterile package encloses the sterile device and the sterile buffer.

24. The apparatus of claim 23, wherein the sterile device is a medical device.

25. The apparatus of claim 23, wherein the sterile device is a sensor.

26. A sterile, implantable medical device for in vivo implantation comprising:

a sterile electronic circuit enclosed in a substantially liquid impervious housing;

a sterile biological molecule for use as an agent in generating a signal to be used by the sterile electronic circuit; and

a sterile reservoir for containing the sterile biological molecule.

27. The device of claim 26, further comprising a sterile package for packaging the device.

28. The device of claim 27, wherein the device is packaged in a wet, sterile buffer solution.

29. The device of claim 28, wherein the device requires no rinsing before implantation.

30. The device of claim 26, wherein the sterile biological molecule is a sensor protein reactive to environmental conditions.

31. The device of claim 26, wherein the sterile electronic circuit is an integrated circuit.

32. The device of claim 26, wherein the sterile reservoir is a polymer.

33. The device of claim 26, further comprising a permeable window covering the biological molecule.

34. The device of claim 26, wherein the device may be used without an acclimation period.

35. The device of claim 27, wherein the package is optically transmissive.

36-44. -44. (canceled)