Treatment of collagenous tissue with glutaraldehyde and aminodiphosphonate calcification inhibitor
First Claim
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1. A process for the treatment of collagenous tissue to adapt it for use in a prosthetic implant and to promote the growth of endothelial cells thereon after implantation, which comprises the steps of:
- (a) contacting said tissue with at least one surfactant for a time sufficient to substantially completely remove deleterious material and open up the fibrous structure of the collagenous tissue;
(b) washing the resulting fibrous matrix to remove substantially all surfactant;
(c) fixing the washed tissue with glutaraldehyde;
(d) treating the glutaraldehyde-fixed tissue with a calcification-inhibiting agent, an agent which inhibits infiltration and attack by phagocytic cells upon implantation and/or an agent which inhibits infection; and
(e) treating the resulting agent/matrix tissue with a reducing agent to stabilize the bonding of the glutaraldehyde of step (c) and the agent of step (d) to the tissue.
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Abstract
A process for the treatment of collagenous tissue to adapt it for use in a prosthetic implant and to promote the growth of endothelial cells thereon after implantation comprising treatment with at least one surfactant prior to fixation, treatment with agents which inhibit calcification and agents which resist attack by phagocytic cells and optional treatment with stabilizing agents.
181 Citations
38 Claims
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1. A process for the treatment of collagenous tissue to adapt it for use in a prosthetic implant and to promote the growth of endothelial cells thereon after implantation, which comprises the steps of:
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(a) contacting said tissue with at least one surfactant for a time sufficient to substantially completely remove deleterious material and open up the fibrous structure of the collagenous tissue; (b) washing the resulting fibrous matrix to remove substantially all surfactant; (c) fixing the washed tissue with glutaraldehyde; (d) treating the glutaraldehyde-fixed tissue with a calcification-inhibiting agent, an agent which inhibits infiltration and attack by phagocytic cells upon implantation and/or an agent which inhibits infection; and (e) treating the resulting agent/matrix tissue with a reducing agent to stabilize the bonding of the glutaraldehyde of step (c) and the agent of step (d) to the tissue. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. A process for the treatment of collagenous tissue to adapt it for use in a prosthetic implant and to promote the growth of endothelial cells thereon after implantation which comprises the sequential combination of the following steps:
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(1) contacting the tissue with at least one surfactant for a time sufficient to substantially completely remove deleterious material and open up the fibrous structure to form a matrix substantially free from lipids, red blood cells, plasma protein, organelles, and dead cell fragments; (2) rinsing the cleaned fibrous matrix resulting from step 1 with distilled water or saline solution to remove substantially all surfactant; (3) soaking said matrix in aqueous glutaraldehyde solution for a time sufficient to bond the glutaraldehyde molecules to substantially all the reactive amino groups present in the protein molecules of the tissue; (4) washing the glutaraldehyde-fixed tissue to remove excess glutaraldehyde; (5) treating the fixed tissue with an aqueous solution of amino diphosphonate containing reactive amino groups for a time sufficient to bond substantially all the free reactive groups of the bonded glutaraldehyde molecules to the reactive amino groups of the amino diphosphonate; (6) washing to remove excess amino diphosphonate; and (7) treating the diphosphonate-bonded tissue matrix with sodium borohydride to stabilize the bonding of the amino diphosphonate and glutaraldehyde to the protein molecules of the tissue; and (8) washing to remove excess sodium borohydride and, if desired, storing the resulting treated tissue in aqueous formaldehyde for subsequent use. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38)
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Specification