Bioengineered vascular graft prostheses
The invention is directed to bioengineered graft prostheses prepared from cleaned tissue material derived from animal sources. The bioengineered graft prostheses of the invention are prepared using methods that preserve cell compatibility, strength, and bioremodelability of the processed tissue matrix. The bioengineered graft prostheses are used for implantation, repair, or use in a mammalian host.
1 . A bioremodelable tubular prosthesis comprising a first layer of processed tissue matrix formed into a tube having a luminal surface and abluminal surface and a second layer of dense fibrillar collagen on the luminal surface of the first layer.
2 . A bioremodelable tubular prosthesis comprising a first layer of processed tissue matrix formed into a tube having a luminal surface and abluminal surface wherein opposing edges of the layer overlap to form a bonding region between about 5% and 20% of the circumference of the tube and a second layer of dense fibrillar collagen on the luminal surface of the first layer.
3 . The bioremodelable tubular prosthesis of claims 1 and 2 wherein the processed tissue matrix is derived from the tunica submucosa of small intestine.
4 . The bioremodelable tubular prosthesis of claims 1 and 2 wherein the prosthesis is crosslinked with EDC.
5 . A method for producing a bioremodelable prosthetic tube construct comprising at least two layers of processed tissue matrix wherein the method comprises:
(a) flagging the processed tissue matrix around a sleeve-covered mandrel by hydrating one edge of the processed tissue matrix and contacting the sleeve-covered mandrel to the hydrated edge of the processed tissue matrix;
(b) drying the processed tissue matrix to the sleeve-covered mandrel;
(c) rehydrating the processed tissue matrix with a hydrating agent to form hydrated processed tissue matrix;
(d) rotating the mandrel twice to wrap the hydrated processed tissue matrix to form two wrapped hydrated layers of processed tissue matrix;
(e) dehydrating the layers of the processed tissue matrix;
(f) removing the processed tissue matrix from the mandrel;
(g) contacting the processed tissue matrix with a crosslinking agent to crosslink the collagen; and,
(h) depositing a dense fibrillar collagen layer on the luminal surface of the tube.
6 . A method for replacing a damaged or diseased portion of vasculature with a bioremodelable tubular prosthesis comprising a two layers of processed tissue matrix and a layer of dense fibrillar collagen on the luminal surface of the tubular prosthesis wherein the method comprises:
(a) anastomosizing a segment of vasculature;
(b) removing the segment of vasculature;
(c) replacing the segment of removed vasculature with a bioremodelable tubular prosthesis;
(d) suturing the bioremodelable tubular prosthesis; and,
(e) removing the anastomoses to resume blood flow.