US5911951A
Expired / Lapsed
US
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Method of sterilization
Assignee: Biomedical Design Inc
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Filing: 1998-02-09
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Granted: 1999-06-15
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Expires: 2018-02-09
Abstract
Abstract Heart valves or other components for replacement of heart or other bodily organs and tissue prostheses or synthetic prosthetic materials are effectively sterilized by treatment with a coupling agent known to create amide linkages between amines and carboxylic acids in the presence of a lower alkanol. Such treatment has been shown to be bactericidal when carried out at 40 DEG C. for over 1 hour. The sterilization treatment preferably employs EDC as a water-soluble coupling agent plus an optional coupling enhancer such as sulfo-NHS or NHS, in the presence of isopropanol or an equivalent alkanol. Such sterilization treatment is preferably carried out at a temperature above ambient temperature in a buffered aqueous solution. The treatment leaves no residuals other than ones which are nontoxic and biocompatible, does not affect the resistance of the tissue to thermal denaturation and to digestion by proteolytic enzymes, and surprisingly also increases the resistance of fixed biological tissue to calcification.
Inventors
- 👤 Jean-Marie Girardot
- 👤 Marie-Nadia Girardot
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 01:49
CPC Classifications
A; A01; A01N; A01N47/00; A01N47/40; A61; A61L; A61L2/00; A61L2/16; A61L2/18; A61L2103/00; A61L2103/05
Claims Analysis
Total Claims: 22
Claim 1
Independent Claim
92 words
A process for sterilization of material by effectively killing microorganisms carried by such material, which process comprises treating such material for an effective length of time with an aqueous solution containing an effective amount of a coupling agent capable of creating amide bonds and an effective amount of an alkanol which achieves penetration of said coupling agent into the cells of microorganisms, in the optional presence of (a) a coupling enhancer that enhances the amide-creating action of said coupling agent so as to increase the number of amide bonds that are created.
Claim 2
Dependent Claim
92 words
A process for sterilization of material by effectively killing microorganisms carried by such material, which process comprises treating such material for an effective length of time with an aqueous solution containing an effective amount of a coupling agent capable of creating amide bonds and an effective amount of an alkanol which achieves penetration of said coupling agent into the cells of microorganisms, in the optional presence of (a) a coupling enhancer that enhances the amide-creating action of said coupling agent so as to increase the number of amide bonds that are created.
Claim 3
Dependent Claim
34 words
The process for sterilization according to claim 1 wherein said alkanol is a C 2 to C 4 alkanol and is included in an amount of at least about 10 volume % of solution.
Claim 4
Dependent Claim
24 words
The process for sterilization according to claim 1 wherein said treatment is carried out at a temperature of out 25° to about 55° C.
Claim 5
Dependent Claim
24 words
The process for sterilization according to claim 1 wherein said treatment is carried out at a temperature of out 35° to about 45° C.
Claim 6
Dependent Claim
20 words
The process for sterilization according to claim 1 wherein said treatment is carried out for at least about 1 hour.
Claim 7
Dependent Claim
20 words
The process for sterilization according to claim 1 wherein said treatment is carried out for at least about 5 hours.
Claim 8
Dependent Claim
25 words
The process for sterilization according to claim 1 wherein said coupling agent is present in said solution a concentration of at least about 5 mM.
Claim 9
Dependent Claim
25 words
The process for sterilization according to claim 1 wherein said coupling agent is present in said solution a concentration of at least about 20 mM.
Claim 10
Dependent Claim
16 words
The process for sterilization according to claim 1 wherein said coupling agent is a water-soluble carbodiimide.
Claim 11
Dependent Claim
14 words
The process for sterilization according to claim 1 wherein said coupling agent is EDC.
Claim 12
Dependent Claim
21 words
The process for sterilization according to claim 10 wherein EDC is present at a concentration of at least about 20 millimolar.
Claim 13
Dependent Claim
22 words
The process for sterilization according to claim 11 wherein said solution contains at least about 1 mM sulfo-NHS as a coupling enhancer.
Claim 14
Dependent Claim
22 words
The process for sterilization according to claim 11 wherein said solution contains at least about 1 mM NHS as a coupling enhancer.
Claim 15
Dependent Claim
25 words
The process for sterilization according to claim 10 wherein said aqueous solution contains at least about 10 grams of isopropanol per 100 ml of solution.
Claim 16
Dependent Claim
41 words
The process for sterilization according to claim 1 wherein said solution contains at least about 20 grams of isopropanol per 100 ml of solution and said treatment is carried out at a temperature of between about 35° and about 45° C.
Claim 17
Dependent Claim
60 words
A process for sterilization of material by effectively killing bacteria and spores carried by such material, which process comprises treating such material for at least about 1 hour with an aqueous solution containing an effective amount of a water-soluble carbodiimide coupling agent capable of creating amide bonds, which solution contains at least about 10 volume % of a lower alkanol.
Claim 18
Dependent Claim
60 words
A process for sterilization of material by effectively killing bacteria and spores carried by such material, which process comprises treating such material for at least about 1 hour with an aqueous solution containing an effective amount of a water-soluble carbodiimide coupling agent capable of creating amide bonds, which solution contains at least about 10 volume % of a lower alkanol.
Claim 19
Dependent Claim
43 words
The process for sterilization according to claim 16 wherein said solution contains at least about 1 mM of a water-soluble coupling enhancer that enhances the amide-creating action of said coupling agent so as to increase the number of amide bonds that are created.
Claim 20
Dependent Claim
27 words
The process for sterilization according to claim 16 wherein said solution contains at least about 20 grams of a C 3 alkanol per 100 ml of solution.
Claim 21
Dependent Claim
83 words
A process for sterilization of biological tissue intended for implantation by effectively killing bacteria and spores, including Bacillus subtilis, carried by such tissue and for increasing the resistance to calcification of such tissue, which process comprises treating such tissue for at least about 1 hour at about 35° C. or higher with an aqueous solution containing at least about 25 mM of a water-soluble carbodiimide coupling agent capable of creating amide bonds, which solution contains at least about 20 volume % of isopropanol.
Claim 22
Dependent Claim
83 words
A process for sterilization of biological tissue intended for implantation by effectively killing bacteria and spores, including Bacillus subtilis, carried by such tissue and for increasing the resistance to calcification of such tissue, which process comprises treating such tissue for at least about 1 hour at about 35° C. or higher with an aqueous solution containing at least about 25 mM of a water-soluble carbodiimide coupling agent capable of creating amide bonds, which solution contains at least about 20 volume % of isopropanol.
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