Self-sealing vascular graft

• US 20070123968A1
• Filed: 09/08/2006
• Published: 05/31/2007
• Est. Priority Date: 11/14/2005
• Status: Active Grant

• Current Assignee: Vascular Devices Pty., Ltd.
• Original Assignee: Artegraft, Inc.
• Inventors: Weinberg, Steven
• Granted Patent: US 8,163,002 B2
• Time in Patent Office: Days
• US Class Current: 623/1.100
• CPC Class Codes: A61M 2039/0072 Means for increasing tightness of the septum, e.g. compression rings, special materials, special constructions
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276

Abstract

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.

Claims

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

a compression element of a biocompatible material overlying said tubular access element providing radially inward compression thereto.

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 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 compression element is a strand-like compression element wound over said access element.

10. The self-sealing vascular graft of claim 9, wherein said strand-like compression element is helically wound about the exterior surface of said access element.

11. The self-sealing vascular graft of claim 9, wherein said strand-like compression element is a polytetrafluoroethylene tape or yarn.

12. The self-sealing vascular graft of claim 9, wherein the width of said strand-like compression element is wide enough so that said strand-like compression element will not be severed when punctured using a hemodialysis needle.

13. The self-sealing vascular graft of claim 9, wherein said strand-like compression element is wound about said access element from the beginning to the end of said access element, wherein said strand-like compression element is secured at said beginning and said end of said access element.

14. The self-sealing vascular graft of claim 13, wherein said strand-like compression element is secured at said beginning and said end of said access element using a biocompatible bonding material.

15. The self-sealing vascular graft of claim 1, wherein said compression element comprises a covering layer surrounding said access element so as to provide radial compression thereto.

16. The self-sealing vascular graft of claim 15, wherein said covering layer 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.

17. The self-sealing vascular graft of claim 15, wherein said covering layer has a durometer hardness of about 20 to about 35 Shore A.

18. The self-sealing vascular graft of claim 15, wherein the wall thickness of said covering layer is from about 0.25 to about 0.55 mm.

19. The self-sealing vascular graft of claim 15, wherein the exterior surface of said covering layer is microporous or textured.

20. 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,

a strand-like compression element of a biocompatible material surrounding said access element providing radially inward compression thereto, and

a covering element of a biocompatible material surrounding said strand-like compression element.

21. The self-sealing vascular graft of claim 20, wherein said biocompatible material for said covering element is selected from the group consisting of a gum silicone elastomer, liquid silicone elastomer, polyether based polyurethane, polycarbonate based polyurethane, polyurethane, and urethane.

22. The self-sealing vascular graft of claim 20, wherein said outer covering element is micro-porous or textured.

23. The self-sealing vascular graft of claim 20, wherein said compression element is arranged about said access element in the form of a spiral winding.

24. A method of making a self-sealing vascular graft comprising:

providing a base tubing element of biocompatible material,

bonding at least one tubular access element of biocompatible material surrounding said base tubing element, and

radially inward compressing said access element with a compression element arranged about said access element.

25. The method of claim 24, wherein said access element is bonded to the exterior surface of said base tubing element by being compression molded or liquid injection molded onto the exterior surface of said base tubing element.

26. The method of claim 24, wherein said access element is bonded to the exterior surface of said base tubing element by forming and partially curing said access element, fitting said access element over said tubing element;

and adhering them together.

27. The method of claim 24, wherein the exterior surface of a portion of said base tubing element or the interior surface of at least a portion of said access element is subjected to surface activation by applying a chemical treatment or a physical treatment.

28. The method of claim 24, wherein said compression element is wound about said access element with a tension causing an increase in self-sealing ability of said access element, while not causing said tubing element to collapse.

29. The method of claim 28, wherein said compression element is wound with a tension in the range of about 10 grams to 300 grams.

30. The method of claim 29, wherein said tension is about 40 grams.

31. The method of claim 28, wherein said compression element is wound about said access element in a helical pattern.

32. The method of claim 31, wherein said helical pattern advances about 1.5 mm per rotation.

33. The method of claim 24, wherein said compression element is wound about said access element in a double helix pattern.

34. The method of claim 33, wherein said double helix pattern advances 2 mm per rotation.