Process for devitalizing soft-tissue engineered medical implants, and devitalized soft-tissue medical implants produced
First Claim
1. A process for preparing a devitalized soft tissue graft for implantation into a mammalian system, comprising:
- extracting a soft tissue sample with an extracting solution comprising a non-denaturing anionic detergent and a first decontaminating agent to produce an extracted tissue comprising cell lysis remnants;
washing at least some cell lysis remnants from said extracted tissue with water and, subsequently placing the extracted, washed tissue into a storage solution comprising a water replacement agent to produce said devitalized soft tissue graft;
wherein said devitalized soft tissue graft retains at least one of non-viable cells or cellular elements capable of inducing graft repopulation with an appropriate cell type, andwherein said process does not include deoxycholic acid or cholic acid.
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Accused Products
Abstract
The invention provides methodologies and apparatus for producing devitalized soft-tissue implants where the implant retains metabolically non-viable and/or reproductively non-viable cells, and preferably retains large molecular weight cytoplasmic proteins, such implants produced both in small quantities and in commercializable quantities. Such soft-tissue implants include vascular graft substitutes. A devitalized graft is produced by subjecting the tissue sample to an induced pressure mediated flow of an extracting solution, optionally followed by inducing a pressure mediated flow of a salt solution, then washing the tissue to produce the devitalized graft. The devitalized grafts produced are uniform and non-immunogenic. The inventive method allows for the production of multiple devitalized soft tissue implants, where processing time is significantly less than prior art processes and the number of implants produced per day is increased over prior art processes. In clinical use, the devitalized grafts produced exhibit significantly improved in long-term durability and function, and enhanced recellularization post-implantation.
91 Citations
41 Claims
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1. A process for preparing a devitalized soft tissue graft for implantation into a mammalian system, comprising:
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extracting a soft tissue sample with an extracting solution comprising a non-denaturing anionic detergent and a first decontaminating agent to produce an extracted tissue comprising cell lysis remnants; washing at least some cell lysis remnants from said extracted tissue with water and, subsequently placing the extracted, washed tissue into a storage solution comprising a water replacement agent to produce said devitalized soft tissue graft; wherein said devitalized soft tissue graft retains at least one of non-viable cells or cellular elements capable of inducing graft repopulation with an appropriate cell type, and wherein said process does not include deoxycholic acid or cholic acid. - View Dependent Claims (2, 3, 4, 5, 6, 7, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41)
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8. A process for preparing a devitalized soft tissue graft for implantation into a mammalian system, comprising:
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extracting a soft tissue sample with an extracting solution comprising a non-denaturing anionic detergent to produce an extracted tissue comprising cell lysis remnants, washing at least some cell lysis remnants from said extracted tissue with water, and subsequently placing the extracted, washed tissue into a storage solution comprising a water replacement agent and a decontaminating agent to produce said devitalized soft tissue graft, wherein said devitalized soft tissue graft retains at least one of non-viable cells or cellular elements capable of inducing graft repopulation with an appropriate cell type, and wherein said process does not include deoxycholic acid or cholic acid. - View Dependent Claims (9, 10, 11, 12)
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Specification