Sterile device and method for producing same

• US 6,923,936 B2
• Filed: 12/28/2001
• Issued: 08/02/2005
• Est. Priority Date: 10/23/2001
• Status: Expired due to Term

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Shah, Rajiv, Reynolds, Jennifer M., Swanson, Aaron J.
• Primary Examiner(s): Warden, Sr., Robert J.
• Assistant Examiner(s): Chorbaji, Monzer R.
• Application Number:
  US10/034,505
• Publication Number:
  US 20050118056A1
• Time in Patent Office: 1,313 Days
• Field of Search: 422/56, 422/82.01, 422/98, 422/1, 422/6, 422/22, 422/24, 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 method for producing a sterile, implantable medical device for in vivo implantation comprising:

providing a device substrate;

affixing non-biological elements to the substrate;

sterilizing the non-biological elements and the substrate with a gaseous sterilant;

affixing biological elements to the substrate;

sterilizing the biological elements with a wet sterilant;

packaging the substrate, the non-biological and biological elements into a wet buffer; and

sterilizing the substrate, the non-biological and biological elements packaged in the wet buffer using light.

2. The method of claim 1, wherein sterilizing the non-biological elements and the substrate with a gaseous sterilant comprises sterilizing the non-biological elements and the substrate with ethylene oxide.

3. The method of claim 1, wherein biological elements are affixed to the substrate after sterilizing the non-biological elements and the substrate with a gaseous sterilant.

4. The method of claim 1, wherein sterilizing the biological elements with a wet sterilant comprises sterilizing the biological elements with glutaraldehyde.

5. The method of claim 1, wherein sterilizing the substrate, the non-biological and biological elements packaged in the wet buffer using light comprises sterilizing the substrate, the non-biological and biological elements packaged in the wet buffer using a broad spectrum pulse light.

6. The method of claim 1, wherein sterilizing the biological elements with a wet sterilant comprises:

preparing a sterilization chamber;

preparing the wet sterilant;

pre-warming the wet sterilant;

loading sensors into the chamber;

exposing the sensors to the wet sterilant;

rinsing the sensors a first time; and

rinsing the sensors a second time.

7. The method of claim 6 wherein rinsing the sensors a first time and a second time comprises rinsing the sensors with a bicarbonate buffer.

8. The method of claim 1, further comprising implanting the device in vivo.

9. The method of claim 8, where in implanting the device in vivo comprises implanting the device in vivo without rinsing.