Laminated self-sealing vascular access graft

• US 6,319,279 B1
• Filed: 10/15/1999
• Issued: 11/20/2001
• Est. Priority Date: 10/15/1999
• Status: Expired due to Fees

• Current Assignee: Access Connections LLC
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Shannon, Don, Kuo, Chris, Tu, Benny
• Primary Examiner(s): O'Connor, Cary E.
• Application Number:
  US09/419,315
• Time in Patent Office: 767 Days
• Field of Search: 623/1.39, 623/1.4, 623/1.1, 623/1, 623/1.44, 623/1.49
• US Class Current: 623/1.44
• CPC Class Codes: A61F 2/06 Blood vessels

Abstract

A vascular access graft that is radially supported and self-sealing upon puncture with, for example, a dialysis needle. The graft has at least one access segment that is formed by an inner layer, an intermediate layer, and outer layer. The intermediate layer has, in longitudinal cross-section, regions of different densities. Radial support members within the intermediate layer prevent collapse of vascular access graft and may be formed of a material that has a lower melting temperature than the other components of the graft. A porous or low-density material is provided between the radial support members to permit blood seepage therein, and the graft is formed by heating to cause the radial support members to melt slightly into the interstitial spaces of the low-density material. The radial support members may be individual turns of a helical coil of FEP, and the low-density material may be compressed PTFE “cotton”. The inner and outer layers may also be formed of PTFE. An adhesive layer of FEP may be provided closely surrounding the inner layer to further anchor the various components of the graft during the step of heating. The inner layer extends on either side of the access segment to provide junction segments that can be cleanly trimmed to size, and which can be used for graft cannulation in lieu of the access segment after suitable tissue ingrowth. A method of manufacture of the vascular access graft is also provided.

Claims

1. A vascular access graft that can be punctured and will seal about the puncture hole, comprising:

an inner tube defining an inner lumen of the graft;

an outer tube concentrically disposed about the inner tube; and

an intermediate tubular layer concentrically positioned between the inner and outer tubes, the intermediate tubular layer comprising, in longitudinal cross-section, alternating regions of materials of different densities, one of the materials being porous to blood, wherein the material of the inner tube is the same as the material of the outer tube.

2. The graft of claim 1, wherein the material of both the inner and outer tubes is PTFE.

3. The graft of claim 1, wherein the porous material of the intermediate layer is the same material as both the inner and outer tubes.

4. The graft of claim 3, wherein the material of both the inner and outer tubes is PTFE that is substantially non-porous to blood, and the porous material of the intermediate layer is low-density PTFE.

5. A vascular access graft that can be punctured and will seal about the puncture hole, comprising:

an inner tube defining an inner lumen of the graft;

an outer tube concentrically disposed about the inner tube; and

an intermediate tubular layer concentrically positioned between the inner and outer tubes, the intermediate tubular layer comprising, in longitudinal cross-section, alternating regions of materials of different densities, one of the materials being porous to blood;

wherein the intermediate tubular layer comprises a plurality of axially-spaced radial support members and regions of less dense material that is porous to blood axially interposed between the radial support members, and

wherein the radial support members comprise individual turns of a helical coil.

6. The graft of claim 5, wherein the porous material of the intermediate layer is low-density PTFE and the radial support members are made of a material that has a lower melting temperature that PTFE.

7. The graft of claim 6, wherein the radial support members are made of FEP.

8. A vascular access graft that can be punctured and will seal about the puncture hole, comprising:

an inner tube defining an inner lumen of the graft;

an outer tube concentrically disposed about the inner tube; and

an intermediate tubular layer concentrically positioned between the inner and outer tubes, the intermediate tubular layer comprising, in longitudinal cross-section, alternating regions of materials of different densities, one of the materials being porous to blood;

wherein the intermediate tubular layer includes a thin adhesive layer closely surrounding the inner tube and bonded to the regions of less dense material.

9. The graft of claim 8, wherein both the radial support members and the adhesive layer are formed of materials that have lower melting temperatures than the regions of less dense material.

10. The graft of claim 9, wherein the radial support members and the adhesive layer are formed of the same material.

11. The graft of claim 10, wherein the radial support members and adhesive layer are formed of FEP, and the regions of less dense material are formed of PTFE.

12. A vascular access graft that can be punctured and will seal about the puncture hole, comprising:

an inner tube defining an inner lumen of the graft;

an outer tube concentrically disposed about the inner tube; and

an intermediate tubular layer concentrically positioned between the inner and outer tubes, the intermediate tubular layer comprising, in longitudinal cross-section, alternating regions of materials of different densities, one of the materials being porous to blood,

wherein the porous material of the intermediate layer comprises a low-density textile-like material that is longitudinally compressed from a relaxed state of the material.

13. A vascular access graft that can be punctured and will seal about the puncture hole, comprising:

an inner tube defining an inner lumen of the graft;

an outer tube concentrically disposed about the inner tube; and

an intermediate tubular layer concentrically positioned between the inner and outer tubes, the intermediate tubular layer comprising, in longitudinal cross-section, alternating regions of materials of different densities, one of the materials being porous to blood,

wherein the low-density textile-like material is made of PTFE.

14. A vascular access graft that can be punctured and will seal about the puncture hole, comprising:

an inner tube defining an inner lumen of the graft;

an outer tube concentrically disposed about the inner tube; and

an intermediate tubular layer concentrically positioned between the inner and outer tubes, the intermediate tubular layer comprising, in longitudinal cross-section, alternating regions of materials of different densities, one of the materials being porous to blood,

wherein the intermediate layer further includes a second material that is substantially non-porous to blood, the low-density textile-like material and second material forming, in longitudinal cross-section, the alternating regions of the vascular access graft, and wherein the vascular access graft is formed by bonding the second material to the low-density textile-like material.

15. The graft of claim 14, wherein the second material has a lower melting temperature than the low-density textile-like material, and the bonding is accomplished by laminating the second material to the low-density textile-like material.

16. The graft of claim 15, wherein the second material comprises radial support members, and the vascular access graft is formed by heating the radial support members causing them to melt and migrate into interstitial spaces formed in the low-density textile-like material.

17. A vascular access graft that can be punctured and will seal about the puncture hole, comprising:

an inner tube defining an inner lumen of the graft;

an intermediate tubular layer having a porosity and concentrically fitted around the inner tube;

a plurality of radial support members concentrically fitted around the intermediate tubular layer; and

an outer tube concentrically disposed about the intermediate tubular layer and radial support members,

wherein the plurality of radial support members define axial spaces therebetween, and the intermediate tubular layer is further axially interposed between the radial support members,

wherein the radial support members comprise individual turns of a helical coil,

wherein the intermediate tubular layer is low-density PTFE and the radial support members are made of a material that has a lower melting temperature that PTFE.

18. The graft of claim 17, wherein the radial support members are made of FEP.

19. A vascular access graft that can be punctured and will seal about the puncture hole, comprising:

an inner tube defining an inner lumen of the graft;

an intermediate tubular layer having a porosity and concentrically fitted around the inner tube;

a plurality of radial support members concentrically fitted around the intermediate tubular layer;

an outer tube concentrically disposed about the intermediate tubular layer and radial support members, and

a thin adhesive layer closely surrounding the inner tube and bonded to the intermediate tubular layer.

20. The graft of claim 19, wherein both the radial support members and the adhesive layer are formed of materials that have a lower melting temperatures than the material of the intermediate tubular layer.

21. The graft of claim 20, wherein the radial support members and the adhesive layer are formed of the same material.

22. The graft of claim 21, wherein the radial support members and adhesive layer are formed of FEP, and the intermediate tubular layer is formed of PTFE.

23. A method of manufacturing a vascular access graft, comprising:

placing an inner layer on a mandrel;

positioning a tube of low-density material over the inner layer, the tube having a first density;

compressing the tube of low-density material to a second density higher than the first density;

providing a plurality of axially spaced radial support members over the compressed tube of low-density material;

closely surrounding the assembly of the tube of low-density material and radial support members with an outer tubular layer;

bonding the aforementioned components of the vascular access graft; and

removing the mandrel.

24. The method of claim 23, wherein the step of bonding comprises heating.

25. The method of claim 24, where the radial support members are made of the material that has a lower melting temperature than the melting temperature of low-density material, and the step of heating comprises heating the graft to a temperature between the respective melting temperatures of the radial support members and the low-density material.

26. The method of claim 25, wherein the radial support members are made of FEP and the low-density material is made of PTFE.

27. A product, produced by the method of claim 26.

28. A product, produced by the method of claim 25.

29. A product, produced by the method of claim 24.

30. The method of claim 23, wherein the step of compressing comprises:

longitudinally compressing the tube of low-density material to a second length shorter than the first length.

31. A product, produced by the method of claim 30.

32. A product, produced by the method of claim 23.