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EP0267434A2 Expired / Lapsed EP ⏱️ 0.0 years remaining

Process for decreasing residual aldehyde levels in implantable bioprosthetic tissue

Assignee: Baxter International Inc
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Filing: 1987-10-09
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Granted: —
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Expires: 2007-10-09
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Abstract

Abstract Residual aldehyde levels in bioprosthetic tissue are reduced by contacting the tissue with a rinsing solution such that aldehyde which has diffused out of the tissue into the rinsing solution comes into contact with, and reacts with, an amine, thus causing further diffusion of aldehyde out of said tissue. The amine may be dissolved in said rinsing solution or may be immobilized on a solid support to which the rinsing solution is periodically or continuously exposed.

Inventors

  • 👤 Aws Nashef
  • 👤 Ronald Dieck

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-10-23 13:10
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/36; A61L27/3683; A61L27/3687; A01; A01N; A01N1/00; A01N1/10; A01N1/12; A01N1/122; A01N1/128; Y; Y10; Y10S; Y10S623/00; Y10S623/915; Y10S623/916

Claims Analysis

Total Claims: 13
Claim 1
Independent Claim 53 words
A method for decreasing residual aldehyde levels in bioprosthetic tissue previously contacted with said aldehyde, comprising contacting said tissue with a rinsing solution, such that aldehyde which has diffused out of said tissue into said solution contacts and reacts with an amine group, thus causing further diffusion of aldehyde out of said tissue.
Claim 2
Independent Claim 53 words
A method for decreasing residual aldehyde levels in bioprosthetic tissue previously contacted with said aldehyde, comprising contacting said tissue with a rinsing solution, such that aldehyde which has diffused out of said tissue into said solution contacts and reacts with an amine group, thus causing further diffusion of aldehyde out of said tissue.
Claim 3
Dependent Claim 37 words
The method of claim 1 wherein said bioprosthetic tissue is mammalian tissue selected from the group consisting of pericardial tissue, dura mater , fascia lata , amnion, tendon, ligament, cartilage, collagen, arteries, veins, skin patches, and bone.
Claim 4
Dependent Claim 16 words
The method of claim 2 wherein said bioprosthetic tissue is subjected to a calcification mitigation treatment.
Claim 5
Dependent Claim 33 words
The method of claim 3 wherein said tissue is immersed in a rinsing solution, such that efficient diffusion of said aldehyde out of said tissue occurs, and said tissue is rendered substantially non-cytotoxic.
Claim 6
Dependent Claim 20 words
The method of claim 4 wherein said rinsing solution is maintained at a pH between about 7.0 and about 7.6.
Claim 7
Dependent Claim 20 words
The method of claim 5 wherein said rinsing solution is maintained at a temperature between about 4°C and about 45°C.
Claim 8
Dependent Claim 38 words
The method of claim 6 wherein said rinsing solution contains, dissolved within it, said amine in a concentration of from about 0.001M to about 1.0M, such that there is a stoichiometric excess of amino groups over said aldehyde.
Claim 9
Dependent Claim 31 words
The method of claim 7 wherein said amine is bound to a non-toxic solid support, and said rinsing solution is periodically or continuously contacted with said amine immobilized on said support.
Claim 10
Dependent Claim 15 words
The method of claim 8 wherein said periodically changed rinsing solution is substantially amine free.
Claim 11
Dependent Claim 47 words
The method of claim 7, wherein said tissue is repeatedly bathed in said rinsing solution, comprising about 0.1M tris buffer at a pH of about 7.4 at a temperature of about 35°C such that said tissue has a residual aldehyde level below about 1 part per million.
Claim 12
Dependent Claim 35 words
The method of claim 8 wherein every 10 grams (wet weight) of said tissue is immersed in about 100mls of a slurry comprised of said amine immobilized on said support added to said rinsing solution.
Claim 13
Dependent Claim 25 words
Bioprosthetic tissue which has been treated by the method of claims 10 or 11 such that the residual aldehyde level in said tissue is non-cytotoxic.

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