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US 11,027,048 B2Granted
Methods for tissue decellularization
AssigneeDecell Technologies Inc.
InventorPaul Frank Gratzer
Life of this patent
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AssigneeDecell Technologies Inc.
InventorPaul Frank Gratzer
Estimating the term…
A method for producing sterile, decellurized bioprosthetic tissue comprising: (a) contacting a human tissue with a hypotonic solution to produce a lysed tissue, (b) contacting the lysed tissue with a first surfactant to produce a surfactant-treated tissue, (c) contacting the surfactant-treated tissue with a nuclease enzyme solution to produce an enzyme-treated tissue, (d) contacting the enzyme-treated tissue with a cleaning solution comprising a second surfactant, a chaotropic agent or a mixture thereof to produce a decellurized tissue and (e) contacting the decellurized tissue with a bioburden reducing agent to produce the final bioprosthetic tissue. Kits to be used in conjunction with said method, as well as, the bioprosthetic tissue produced via said method are also provided.
A bioprosthetic tissue, wherein the tissue is 95±5% free of nucleic acids, wherein the tissue is 95±5% free of major histocompatibility molecules, wherein the tissue is 95±5% free of Staphylococcus bacteria, Streptococcus bacteria, Enterococcus bacteria, and Bacillus bacteria, or complies with American Association of Tissue Banks Standards for Tissue Banking under K2.200, wherein the collagen structure of the tissue is not altered compared to a fresh control tissue as measured by a Hydrothermal Isometric Tension test, and wherein the bioprosthetic tissue has been prepared from a human tissue having an epidermal cellular layer with an underlying basement membrane matrix such that the human tissue's epidermal cellular layer has been removed, leaving the underlying basement membrane matrix intact in the bioprosthetic tissue.
Dependencies are inferred from the claim text.