Sterile device and method for producing same

• US 7,833,474 B2
• Filed: 03/17/2009
• Issued: 11/16/2010
• Est. Priority Date: 10/23/2001
• Status: Expired due to Fees

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Reynolds, Jennifer M., Swanson, Aaron J., Shah, Rajiv
• Primary Examiner(s): Warden; Jill
• Assistant Examiner(s): Chorbaji; Monzer R.
• Application Number:
  US12/405,840
• Publication Number:
  US 20090177281A1
• Time in Patent Office: 609 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, 205/779
• US Class Current: 422/1
• 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 of making a sterile, implantable medical device for in vivo implantation comprising:

arranging an electronic circuit on a substrate;

sterilizing the electronic circuit and the substrate with a first sterilization technique to provide a sterile electronic circuit and a sterile substrate;

arranging a reservoir on the sterile substrate;

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

then

sterilizing the biological molecule with a second sterilization technique, which is a different type of sterilization technique from the first sterilization technique, to provide a sterile biological molecule.

2. The method of claim 1, further comprising:

arranging a permeable window covering the sterile biological molecule.

3. The method of claim 1, wherein the biological molecule is a sensor matrix protein.

4. The method of claim 1, further comprising:

Packaging the device in a sterile package.

5. The method of claim 4, wherein the package is optically transmissive.

6. The method of claim 1, further comprising:

Packaging the device in a wet, sterile buffer solution.

7. The method of claim 1, wherein the electronic circuit is an integrated circuit.

8. The method of claim 1, wherein the reservoir is a polymer.