Thin collagen tissue for medical device applications
OwnerKemal Schankereliinventor
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Abstract
This invention relates to processes of preparing heterogeneous graft material from animal tissue. Specifically, the invention relates to the preparation of animal tissue, in which the tissue is cleaned and chemically cross-linked using both vaporized and liquid cross-linking agents, resulting in improved physical properties such as thin tissue and lowered antigenicity, thereby increasing the ease of delivering the tissue during surgery and decreasing the risk of post-surgical complication, respectively.
Claims43
A process of preparing a bioprosthetic or implant tissue material for use in surgical procedures on humans comprising the steps of:
- (a) vapor cross-linking a pre-digested compressed tissue specimen by exposing the tissue specimen to a vapor of a cross-linking agent selected from the group consisting of aldehydes, epoxides, isocyanates, carbodiimides, isothiocyanates, glycidalethers, and acyl azides;
- and
- (b) chemically cross-linking the vapor-cross-linked tissue specimen by exposing the vapor-crosslinked tissue specimen to an aqueous crosslinking bath for a predetermined time, such crosslinking bath containing a liquid phase of a crosslinking agent selected from the group consisting of aldehydes, epoxides, isocyanates, carbodiimides, isothiocyanates, glycidalethers, and acyl azides.
A process of preparing animal-derived collagen tissue material for use in surgical procedures on humans comprising the steps of:
- vapor cross-linking a pre-digested collagen tissue specimen by exposing the tissue specimen to a formaldehyde vapor phase;
- and subjecting the vapor-crosslinked collagen tissue specimen to an aqueous glutaraldehyde bath for a predetermined time.
A process of preparing a bioprosthetic transcatheter valve material for use in surgical procedures on humans comprising the steps of:
- vapor cross-linking a pre-digested compressed bovine pericardium tissue specimen by exposing the tissue specimen to a formaldehyde vapor phase;
- and subjecting the vapor-crosslinked tissue specimen to an aqueous glutaraldehyde bath for a predetermined time.
A process of preparing heterogenous or homogenous tissue material for use in surgical procedures on humans wherein an animal collagen tissue specimen is chemically cross-linked first by exposing the tissue to formaldehyde vapor for approximately 10 minutes, and second by immersing the tissue in a glutaraldehyde solution for two consecutive sessions of approximately 24 hours each.
A process of converting a pericardial tissue specimen taken from a porcine, ovine or bovine animal not more than 30 days old to a non-antigenic, non-thrombogenic, calcification-resistant implantable material for use in surgical procedures on humans wherein the pericardial tissue specimen is cleaned, digested by surfactant, compressed to approximately 0.002″ (0.0508 mm) to 0.005″ (0.127 mm) in thickness, vapor cross-linked by exposing the tissue to a vapor-phase cross-linking agent selected from the group consisting of aldehydes, epoxides, isocyanates, carbodiimides, isothiocyanates, glycidalethers, and acyl azides, and liquid-phase cross-linked by immersing the tissue in a liquid cross-linking agent selected from the group consisting of aldehydes, epoxides, isocyanates, carbodiimides, isothiocyanates, glycidalethers, and acyl azides.
A process of converting pericardial tissue specimen taken from a porcine, ovine or bovine animal not more than 30 days old to a non-antigenic, non-thrombogenic, calcification-resistant implantable material for use in surgical procedures on humans wherein the pericardial tissue specimen is cleaned, digested by surfactant, compressed to approximately 0.002″ (0.0508 mm) to 0.005″ (0.127 mm) in thickness, vapor cross-linked by exposing the tissue to formaldehyde vapor for approximately 10 minutes, and further cross-linked by immersing in a glutaraldehyde solution for at least 24 hours.
Dependencies are inferred from the claim text.