Regenerative tissue and natural tissue implants
The present invention is an improved implant made from regenerative tissue or natural tissue, methods of making the implant, and methods of using the implant.
1 . A prosthesis comprising biologically engineered extracellular matrix (ECM) tissue formed into pre-determined shape, wherein a central portion of said prosthesis is isodiametric, a first end of said prosthesis is flared, and a second end of said prosthesis is a cuff, wherein an internal diameter of said central portion is from 2 mm to 6 mm, or wherein the internal diameter is from 2 mm to 4 mm, or wherein the internal diameter is from 3 mm to 6 mm.
2 . A process for making a prosthesis comprising culturing regenerative extracellular matrix (ECM) tissue, wherein said culturing occurs around a mandrel, shape or form and results in a shaped prosthesis; removing the shaped prosthesis from the mandrel, shape, or form; and shaping at least one end of said prosthesis, wherein a central portion of said prosthesis is isodiametric, a first end of said prosthesis is flared, and a second end of said prosthesis is a cuff, wherein an internal diameter of said central portion is from 2 mm to 6 mm, or wherein the internal diameter is from 2 mm to 4 mm, or wherein the internal diameter is from 3 mm to 6 mm.
3 . A process for preparing a graft comprising the steps of: 1) selecting an animal tissue specimen; 2) cleaning the selected tissue to produce a cleaned tissue; 3) digesting the cleaned tissue with at least one enzyme to produce digested tissue; 4) surface-treating the digested tissue to produce surface-treated tissue; 5) forming the surface-treated tissue into a predetermined shape to produce formed tissue, wherein a central portion of said shape is isodiametric, a first end of said shape is flared, and a second end of said shape is a cuff; 6) crosslinking the formed tissue to produce crosslinked tissue; and 7) sterilizing the crosslinked tissue, wherein an internal diameter of said central portion is from 2 mm to 6 mm, or wherein the internal diameter is from 2 mm to 4 mm, or wherein the internal diameter is from 3 mm to 6 mm.
4 . The process of claim 3 wherein the tissue specimen is a ureter.
5 . The process of claim 3 wherein the pre-determined shape corresponds to an anastomosis site on a recipient blood vessel.
6 . The prosthesis of claim 1 configured as a coronary artery bypass graft or a peripheral graft.
7 . The prosthesis of claim 1 , wherein a length of said prosthesis is from 20 cm to 60 cm.
8 . The prosthesis of claim 1 , wherein a length of said prosthesis is from 40 cm to 120 cm.