EP0458877B1
Expired / Lapsed
EP
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Calcification mitigation of bioprosthetic implants
Assignee: Baxter International Inc
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Filing: 1990-02-01
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Granted: 1995-05-17
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Expires: 2010-02-01
Abstract
Abstract Calcification resistant bioprosthetic implants are made from tanned biological materials, such as porcine heart valves, bovine pericardium, human dura mater or the like, which has been impregnated with a calcification-mitigating effective amount of a ferric and/or stannic salt, and having been treated with one or more diamines in combination with one or more activating factors. The impregnated biological materials and processes are particularly advantageous for the preparation of bioprosthetic heart valves. These implants have been found to be highly resistant to calcification in vivo.
Inventors
- 👤 Alain Carpentier
- 👤 Sophie Carpentier
- 👤 Aws Nashef
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-29 04:21
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/36; A61L27/3683; A61L27/3687; A61L2400/00; A61L2400/02; A61L2430/00; A61L2430/40
Claims Analysis
Total Claims: 19
Claim 1
Independent Claim
115 words
A process of preparing biologically-derived tissue comprising:- (a) treating the biologically-derived tissue with: i) either sufficient of a tanning solution adequately to tan the tissue; or ii) sufficient of a solution of a soluble, substantially non-toxic ferric salt, stannic salt or a combination thereof to mitigate calcification of the tissue in vivo ; (b) subsequently treating the tissue with sufficient of the other of the solutions, wherein the tanning solution is not a solution of a ferric salt, stannic salt or a combination thereof; and (c) treating the tissue with a diamine and an activating factor for initiating reaction of the diamine with the tissue, this step being performed before step (a) or step (b)
Claim 2
Dependent Claim
22 words
The process of claim 1 wherein the tissue is treated with said diamine and said activating factor as a single aqueous solution.
Claim 3
Dependent Claim
14 words
The process of claim 1 or 2 wherein said activating factor is a carbodiimide.
Claim 4
Dependent Claim
10 words
The process of claim 3 wherein said carbodiimide is 1-ethyl-3(3-dimethylaminopropyl)-carboidimide-HCL.
Claim 5
Dependent Claim
23 words
The process of any preceding claim wherein the salt is a nitrate, sulfate, borate, carbonate, halide, citrate or acetate of ferric or stannic.
Claim 6
Dependent Claim
30 words
The process of claim 5 wherein the salt is ferric nitrate, stannic nitrate, ferric sulfate, stannic sulfate, ferric chloride, stannic chloride, ferric citrate, stannic citrate, ferric acetate or stannic acetate.
Claim 7
Dependent Claim
23 words
The process of claim 5 or 6 wherein the salt is dissolved in an aqueous solution of water-miscible alcohol, glycol, triol, or aldehyde.
Claim 8
Dependent Claim
20 words
The process of claim 7 wherein the salt is dissolved in an aqueous solution of ethanol, formaldehyde, glutaraldehyde, or glycerol.
Claim 9
Dependent Claim
33 words
The process of claim 8 wherein the solution contains up to about 30% ethanol, up to about 5% formaldehyde, up to about 1% glutaraldehyde, or up to about 30% glycerol, or mixtures thereof.
Claim 10
Dependent Claim
23 words
The process of any preceding claim wherein the pH of said ferric and/or stannic salt solution ranges from about 2 to about 7.
Claim 11
Dependent Claim
22 words
The process of claim 10 wherein the pH of said ferric or stannic salt solution ranges from about 2 to about 3.
Claim 12
Dependent Claim
29 words
The process of any preceding claim wherein the said ferric or stannic salt solution contains from about 0.01% to about 2.5% by weight of the ferric or stannic salt.
Claim 13
Dependent Claim
26 words
The process of claim 12 wherein the said ferric or stannic salt solution contains from about 0.05% to about 15% of the ferric or stannic salt.
Claim 14
Dependent Claim
31 words
The process of any preceding claim wherein said diamine is selected from those having the formula: R-(NH₂)₂ Wherein: R is a C₁-C₁₀ cyclic or noncylic alkyl, aryl, alkylene, arylalkyl, arylalkylene radical.
Claim 15
Dependent Claim
13 words
The process of claim 14 wherein R is a straight chain aliphatic group.
Claim 16
Dependent Claim
11 words
The process of any preceding claim wherein said diamine is ethylenediamine.
Claim 17
Dependent Claim
19 words
The process of any preceding claim wherein said biological tissue is in the form of a porcine heart valve.
Claim 18
Dependent Claim
31 words
The process of any preceding claim wherein said tissue is treated with said diamine at a rate of one-hundred fifty moles diamine to every one mole of collagen of said tissue.
Claim 19
Dependent Claim
31 words
The process of any preceding claim wherein said tissue is treated with said activating factor at a rate of five times the amount of carboxylic residues of collagen of said tissue.
References Cited (Backward Citations)
US4378224A
Cited
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