US20040030405A1
Expired / Lapsed
US
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Methods for treating implantable biological tissues to mitigate the calcification thereof and bioprosthetic articles treated by such methods
Assignee: Individual
•
Filing: 2003-02-05
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Granted: —
•
Expires: 2023-02-05
Abstract
Abstract A method for treating fixed biological tissue inhibits calcification of the biological tissue following implantation thereof in a mammalian body. The method includes placing the biological tissue in contact with glutaraldehyde and then heating the glutaraldehyde. Alternatively, methods other than heating (e.g., chemical or mechanical means), for effecting polymerization of the glutaraldehyde may also be utilized. Alternatively, the tissue may be heat treated prior to fixing thereof. Alternatively, methods other than glutaraldehyde may also be used for fixing the tissue. The biological tissue may be so treated at any time prior to implantation thereof in a mammalian body.
Inventors
- 👤 Sophie Carpentier
- 👤 Alain Carpentier
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-22 19:30
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/36; A61L27/3683; A61L27/3687; A61L27/3604; A61L2400/00; A61L2400/02; Y; Y10; Y10S; Y10S623/00; Y10S623/915
Claims Analysis
Total Claims: 30
Claim 1
Independent Claim
42 words
1 . A method for treating glutaraldehyde fixed biological tissue to inhibit calcification of said tissue following implantation in a mammalian body, said method comprising the steps of: a) placing the biological tissue in contact with glutaraldehyde; and b) heating the glutaraldehyde.
Claim 2
Dependent Claim
42 words
1 . A method for treating glutaraldehyde fixed biological tissue to inhibit calcification of said tissue following implantation in a mammalian body, said method comprising the steps of: a) placing the biological tissue in contact with glutaraldehyde; and b) heating the glutaraldehyde.
Claim 3
Dependent Claim
82 words
2 . The method as recited in claim 1 wherein the step, of placing the biological tissue in contact with glutaraldehyde comprises placing the biological tissue in contact with an approximately 0.625% solution of glutaraldehyde comprising: a) approximately 26 ml/l glutaraldehyde (25%); b) approximately 4.863 g/l HEPES buffer; c) approximately 2.65 g/l MgCl 2 .6H 2 0 ; d) approximately 4.71 g/l NaCl; e) balance of solution double filtered H 2 O; and f) sufficient NaOH to adjust pH to approximately 7.4.
Claim 4
Dependent Claim
26 words
3 . The method as recited in claim 1 wherein the step of heating the glutaraldehyde comprises heating said solution of glutaraldehyde to approximately 35-55° C.
Claim 5
Dependent Claim
24 words
4 . The method as recited in claim 1 wherein the step of heating the glutaraldehyde comprises heating said glutaraldehyde for approximately 4-22 weeks.
Claim 6
Dependent Claim
28 words
5 . The method as recited in claim 1 wherein the step of heating the glutaraldehyde comprises heating said glutaraldehyde during the process of fixing the biological tissue.
Claim 7
Dependent Claim
33 words
6 . The method as recited in claim 1 wherein the step of heating the glutaraldehyde comprises heating said glutaraldehyde after fixing of the biological tissue and before storage of the biological tissue.
Claim 8
Dependent Claim
26 words
7 . The method as recited in claim 1 wherein the step of heating the glutaraldehyde comprises heating said glutaraldehyde after storage of the biological tissue.
Claim 9
Dependent Claim
28 words
8 . The method as recited in claim 6 wherein the step of heating the glutaraldehyde comprises heating said glutaraldehyde in which the biological tissue is subsequently stored.
Claim 10
Dependent Claim
50 words
9 . The method as recited in claim 1 wherein the biological tissue is stored in a glutaraldehyde solution after fixation of the tissue has been completed and wherein the step of heating the solution of glutaraldehyde comprises heating the solution of glutaraldehyde in which the biological tissue is stored.
Claim 11
Dependent Claim
45 words
10 . The method as recited in claim 1 wherein the tissue is treated, after fixation treatment with an antimineralization treatment solution containing glutaraldehyde, and wherein the step of heating the glutaraldehyde comprises heating glutaraldehyde containing antimineralization treatment solution with which said tissue is treated.
Claim 12
Dependent Claim
42 words
11 . A method for treating glutaraldehyde fixed biological tissue to inhibit calcification following implantation in a mammalian body, the method comprising the steps of: a) disposing the biological tissue in a solution of glutaraldehyde; and b) causing the glutaraldehyde to polymerize.
Claim 13
Dependent Claim
42 words
11 . A method for treating glutaraldehyde fixed biological tissue to inhibit calcification following implantation in a mammalian body, the method comprising the steps of: a) disposing the biological tissue in a solution of glutaraldehyde; and b) causing the glutaraldehyde to polymerize.
Claim 14
Dependent Claim
19 words
12 . The method of claim 11 wherein step (b) comprises applying heat to cause said glutaraldehyde to polymerize.
Claim 15
Dependent Claim
23 words
13 . The method of claim 11 wherein step (b) comprises adding a chemical to the glutaraldehyde to cause the glutaraldehyde to polymerize.
Claim 16
Dependent Claim
20 words
14 . The method of claim 11 wherein step (b) comprises utilizing mechanical means to cause the glutaraldehyde to polymerize.
Claim 17
Dependent Claim
82 words
15 . The method as recited in claim 11 wherein the step of disposing the biological tissue in a solution of glutaraldehyde comprises dispensing the biological tissue in an approximately 0.625% solution of glutaraldehyde comprising: a) approximately 26 ml/l glutaraldehyde (25%); b) approximately 4.863 g/l HEPES buffer; c) approximately 2.65 g/l MgCl 2 .6H 2 0 ; d) approximately 4.71 g/l NaCl; e) balance of solution double filtered H 2 0 ; and f) sufficient NaOH to adjust pH to approximately 7.4.
Claim 18
Dependent Claim
12 words
16 . A bioprosthesis formed by the process of claim 1 .
Claim 19
Dependent Claim
34 words
17 . The bioprosthesis of claim 16 wherein the fixed biological tissue comprises: a) a cardiac valve; b) vascular tissue; c) skin; d) dura mater; e) pericardium; f) a ligament; and/or g) a tendon.
Claim 20
Dependent Claim
24 words
18 . The bioprosthesis of claim 16 wherein the step of heating the glutaraldehyde comprises heating said glutaraldehyde during fixing of the biological tissue.
Claim 21
Dependent Claim
31 words
19 . The bioprosthesis of claim 16 wherein the step of heating the glutaraldehyde comprises heating said glutaraldehyde after fixing of the biological tissue and before storage of the biological tissue.
Claim 22
Dependent Claim
24 words
20 . The bioprosthesis of claim 16 wherein the step of heating the glutaraldehyde comprises heating said glutaraldehyde after storage of the biological tissue.
Claim 23
Dependent Claim
26 words
21 . The bioprosthesis of claim 16 wherein the step of heating the glutaraldehyde comprises heating glutaraldehyde containing antimineralization solution with which said tissue is treated.
Claim 24
Dependent Claim
12 words
22 . A bioprosthesis formed by the process of claim 11 .
Claim 25
Dependent Claim
34 words
23 . The bioprosthesis of claim 22 wherein the fixed biological tissue comprises: a) a cardiac valve; b) vascular tissue; c) skin; d) dura mater; e) pericardium; f) a ligament; and/or g) a tendon.
Claim 26
Dependent Claim
20 words
24 . The bioprosthesis of claim 22 wherein the step of causing the glutaraldehyde to polymerize comprises heating said glutaraldehyde.
Claim 27
Dependent Claim
31 words
25 . The bioprosthesis of claim 22 wherein the step of causing the glutaraldehyde to polymerize is carried out during fixing of the biological tissue and before storage of the bioprosthesis.
Claim 28
Dependent Claim
25 words
26 . The bioprosthesis of claim 22 wherein the step of causing the glutaraldehyde to polymerize is carried out after fixation but prior to bioprosthesis.
Claim 29
Dependent Claim
32 words
27 . The bioprosthesis of claim 22 wherein the step of causing the glutaraldehyde to polymerize is carried out concomitantly with exposure of the bioprosthesis to a glutaraldehyde containing antimineralization treatment solution.
Claim 30
Dependent Claim
32 words
28 . The bioprosthesis of claim 22 wherein the step of causing the glutaraldehyde to polymerize is carried out after fixation and during storage of the bioprosthesis in a glutaraldehyde—containing storage solution.
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