Self-sealing vascular graft
The present invention relates to a segmental self-sealing graft for implantation in a patient including a base tubing element, a tubular access element overlying the base tubing, and a strand-like compression element wound over the access element so as to provide radially inward compression, and a method of making same.
1. A self-sealing vascular graft for implantation in a patient comprising:
a base tubing element of a biocompatible material,
at least one tubular access element overlying said base tubing element, wherein said access element is made of a biocompatible material and said base tubing element and said access element are adhered to each other over substantially the entire length of said access element so they do not delaminate when punctured, wherein said access element is a homogeneous continuous structure over substantially the entire length of said access element, and
a compression element of a biocompatible material surrounding said tubular access element, said compression element providing radially inward compression about said access element sufficient to increase the self-sealing ability of said access element without causing said base tubing element to collapse, wherein said compression element is a homogeneous continuous structure over substantially the entire length of said compression element.
2. The self-sealing vascular graft of claim 1 , wherein said biocompatible material for said base tubing element is polyurethane or polyester.
3. The self-sealing vascular graft of claim 1 , wherein said biocompatible material for said base tubing element is expanded polytetrafluoroethylene.
4. The self-sealing vascular graft of claim 1 , wherein said access element is comprised of two access elements, wherein one of said two access element is adapted for removal of untreated blood and the other access element is adapted for the return of filtered blood.
5. The self-sealing vascular graft of claim 1 , wherein said biocompatible material for said access element is selected from the group consisting of a gum silicone elastomer, liquid silicon elastomer, polyether based polyurethane, polycarbonate based polyurethane, polyurethane and urethane.
6. The self-sealing vascular graft of claim 1 , wherein said biocompatible material for said access element is a platinum-cured gum silicone elastomer.
7. The self-sealing vascular graft of claim 1 , wherein said access element has a wall thickness of about 0.3 mm to about 1.5 mm.
8. The self-sealing vascular graft of claim 1 , wherein said access element has a wall thickness of about 0.5 mm to about 1.0 mm.
9. The self-sealing vascular graft of claim 1 , wherein said biocompatible material for said compression element is selected from the group consisting of a platinum cured silicone gum elastomer, liquid silicone elastomer, polyether based polyurethane, polycarbonate based polyurethane, polyurethane, and urethane.
10. The self-sealing vascular graft of claim 1 , wherein said compression element has a durometer hardness of about 20 to about 35 Shore A.
11. The self-sealing vascular graft of claim 1 , wherein the wall thickness of said compression element is from about 0.25 mm to about 0.55 mm.
12. The self-sealing vascular graft of claim 1 , wherein the exterior surface of said compression element is microporous or textured.
13. The self-sealing vascular graft of claim 1 , wherein said biocompatible material for said base tubing element is expanded polytetrafluorethylene; said biocompatible material for said access element is a platinum-cured gum silicone elastomer; and said biocompatible material for said compression element is a platinum cured silicone gum elastomer.
14. The self-sealing vascular graft of claim 13 , wherein said access element has a wall thickness of about 0.33 mm to about 1.5 mm; and said compression element has a wall thickness of about 0.25 mm to about 0.55 mm, wherein the exterior surface of said compression element is microporous or textured.
15. The self-sealing vascular graft of claim 1 , wherein the biocompatible material of said access element is worked in surface pores of the base tubing element.
16. A self-sealing vascular graft for implantation in a patient produced by steps comprising:
providing a base tubing element of biocompatible material,
adhering at least one tubular access element of biocompatible material to the exterior surface of said base tubing element over substantially the entire length of said access element by compression molding or liquid injection molding technique so that said base tubing element and said access element do not delaminate when punctured, wherein said access element is a homogeneous continuous structure over substantially the entire length of said access element,
providing a compression element of a biocompatible material over the exterior surface of said at least one tubular access element, said compression element providing radially inward compression about said access element sufficient to increase the self-sealing ability of said access element without causing said base tubing element to collapse, wherein said compression element is a homogeneous continuous structure over substantially the entire length of said access element.
17. The self-sealing vascular graft of claim 16 , wherein said biocompatible material for said base tubing element is or expanded polytetrafluorethylene; said biocompatible material for said access element is a platinum-cured gum silicone elastomer; and said biocompatible material for said compression element is a platinum cured silicone gum elastomer.
18. The self-sealing vascular graft of claim 17 , wherein said access element has a wall thickness of about 0.33 mm to about 1.5 mm; and said compression element has a wall thickness of about 0.25 mm to about 0.55 mm, wherein the exterior surface of said compression element is microporous or textured.