STERILE DEVICE AND METHOD FOR PRODUCING SAME
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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.
133 Citations
44 Claims
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1-35. -35. (canceled)
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36. A method for producing a sterile, implantable medical device for in vivo implantation comprising:
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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. - View Dependent Claims (37, 38, 39, 40, 41, 42, 43, 44)
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Specification