STERILE DEVICE AND METHOD FOR PRODUCING SAME

• US 20090177281A1
• Filed: 03/17/2009
• Published: 07/09/2009
• 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 7,833,474 B2
• Time in Patent Office: Days
• US Class Current: 623/11.110
• 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, implantable medical device for in vivo implantation comprising:

a sterile electronic circuit;

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 housing the sterile biological molecule,

wherein the sterile biological molecule is a sensor matrix protein.

2. The device of claim 1, further comprising a sterile package for packaging the device.

3. The device of claim 2, wherein the device is packaged in a wet, sterile buffer solution.

4. The device of claim 3, wherein the device requires no rinsing before implantation.

5. The device of claim 1, wherein the sterile electronic circuit is an integrated circuit.

6. The device of claim 1, wherein the sterile reservoir is a polymer.

7. The device of claim 1, further comprising a permeable window covering the biological molecule.

8. The device of claim 1, wherein the device may be used without an acclimation period.

9. The device of claim 2, wherein the package is optically transmissive.

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

a sterile electronic circuit;

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

a sterile reservoir for housing the sterile biological molecule; and

a permeable window covering the biological molecule.

11. The device of claim 10, further comprising a sterile package for packaging the device.

12. The device of claim 11, wherein the device is packaged in a wet, sterile buffer solution.

13. The device of claim 12, wherein the device requires no rinsing before implantation.

14. The device of claim 10, wherein the sterile biological molecule is a sensor matrix protein.

15. The device of claim 10, wherein the sterile electronic circuit is an integrated circuit.

16. The device of claim 10, wherein the sterile reservoir is a polymer.

17. The device of claim 10, wherein the device may be used without an acclimation period.

18. The device of claim 11, wherein the package is optically transmissive.