AV grafts with rapid post-operative self-sealing capabilities

• US 7,452,374 B2
• Filed: 04/24/2003
• Issued: 11/18/2008
• Est. Priority Date: 04/24/2003
• Status: Expired due to Fees

• Current Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Original Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Inventors: King, Tamara, Hain, Matt
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US10/422,118
• Publication Number:
  US 20040215337A1
• Time in Patent Office: 2,035 Days
• Field of Search: 623 132- 154
• US Class Current: 623/1.44
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: A61L 33/0005 Use of materials characterised by their function or physical properties
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 7/02 Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

Abstract

The invention provides a self-sealing arteriovenous graft including a tube having a polymeric inner layer defining a lumen through which blood may flow and an outer textile layer. The outer textile layer is concentrically disposed about the inner layer. Furthermore, an intermediate self-sealing layer is concentrically positioned between the inner and outer layers. The self-sealing layer includes a biocompatible polymer.

Claims

1. A self-sealing arteriovenous access graft comprising:

a polymeric inner layer defining a lumen through which blood may flow;

an outer textile layer concentrically disposed about the inner layer, said outer textile layer comprising biodegradable fibers comprising calcium alginate fibers; and

an intermediate self-sealing tubular layer concentrically positioned between the inner and outer layers, said self-sealing layer being uninterrupted circumferentially about, and in full face-to-face contiguous contact with, said inner layer, said self-sealing layer comprising a biocompatible polymer, said self-sealing layer having a thickness of about 0.1 mm. to about 3 mm. which prevents blood leakage when punctured for dialysis,

wherein said graft is configured to have a burst pressure of at least about 80 psi after repeated punctures for dialysis.

2. The graft according to claim 1, wherein said self-sealing layer is selected from the group consisting of silicone, polyurethane, polyurethane-carbonates and combinations thereof.

3. The graft according to claim 1, wherein said self-sealing layer comprises a silicone elastomer.

4. The graft according to claim 1, wherein said self-sealing layer comprises foamed polymer.

5. The graft according to claim 1, wherein said self-sealing layer further comprises a bio-therapeutic agent selected from the group consisting of thrombo-resistant agents, antibiotics, anti-tumor agents, anti-viral agents and combinations thereof.

6. The graft according to claim 1, wherein said self-sealing layer further comprises thrombo-resistant agents.

7. The graft according to claim 1, wherein said polymeric inner layer comprises ePTFE.

8. The graft according to claim 1, wherein the textile outer layer is selected from the group consisting of a knitted layer, a woven layer, a braided layer and a non-woven layer.

9. The graft according to claim 1, wherein the textile outer layer is a knitted layer.

10. The graft according to claim 9, wherein the knitted layer is warp knitted.

11. The graft according to claim 10, wherein the warp-knit is selected from the group consisting of a tricot and a double tricot pattern.

12. The graft according to claim 1, wherein said outer layer is shorter than said inner layer and is positioned over the center of the inner layer thereby allowing the ends of the inner layer to extend beyond each of the ends of the outer layer.

13. The graft according to claim 1, wherein said inner layer is shorter than said outer layer and is positioned over the center of the inner layer thereby allowing the ends of the outer layer to extend beyond each of the ends of the inner layer.

14. A self-sealing arteriovenous graft comprising:

a polymeric inner layer defining a lumen through which blood may flow, said inner layer comprising ePTFE;

an outer knit layer concentrically disposed about the inner layer, said outer layer comprising biodegradable fibers comprising calcium alginate fibers, and

an intermediate self-sealing tubular layer concentrically positioned between the inner and outer layers, said self-sealing layer being uninterrupted circumferentially about, and in full face-to-face contiguous contact with, said inner layer, said self-sealing layer comprising a silicone elastomer, said self-sealing layer having a thickness of about 0.01 mm. to about 1.0 mm. which prevents blood leakage when punctured for dialysis,

wherein said graft is configured to have a burst pressure of at least about 80 psi after repeated punctures for dialysis.

15. The graft according to claim 14, wherein said knit layer is of a pattern selected from the group consisting of tricot and double tricot.

16. The graft according to claim 14, wherein said self-sealing layer has a thickness of about 0.5 mm to about 0.75 mm.