Porous synthetic vascular grafts with oriented ingrowth channels

• US 6,540,780 B1
• Filed: 11/05/1999
• Issued: 04/01/2003
• Est. Priority Date: 11/23/1998
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Zilla, Peter Paul, Bezuidenhout, Deon
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): Bui, Vy Q.
• Application Number:
  US09/434,071
• Time in Patent Office: 1,243 Days
• Field of Search: 623/1--, 623/1.23, 623/1.25, 623/1.36, 623/1.39, 623/1.42, 623/1.44, 623/1.45, 623/1.46, 623/1.49, 606/108, 606/191, 606/194, 606/195, 606/198
• US Class Current: 623/1.39
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: B29C 48/022 characterised by the choice of material
• CPC Class Codes: B29C 48/05 Filamentary, e.g. strands
• CPC Class Codes: B29C 48/09 Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
• CPC Class Codes: B29C 48/32 with annular openings, e.g. for forming tubular articles
• CPC Class Codes: B29C 53/587 having a non-uniform wall-structure, e.g. with inserts, perforations, locally concentrated reinforcements
• CPC Class Codes: B29C 53/665 Coordinating the movements of the winding feed member and the mandrel
• CPC Class Codes: B29K 2075/00 Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2105/045 with open cells
• CPC Class Codes: B29K 2105/06 containing reinforcements, fillers or inserts
• CPC Class Codes: B29K 2105/101 Oriented
• CPC Class Codes: B29L 2031/7534 Cardiovascular protheses
• CPC Class Codes: C08L 75/04 Polyurethanes

Abstract

A vascular prosthesis is constructed from a structure having interconnected, helically oriented channel-porosity to allow oriented ingrowth of connective tissue into a wall of the prosthesis. The prosthesis can have a small internal diameter of 6 mm or less. Several different methods can be used to produce the prosthesis, including a fiber winding and extraction technique, a melt extrusion technique, and a particle and fiber extraction technique using either a layered method or a continuous method. Furthermore, mechanical properties of the prosthesis are matched with mechanical properties of the host vessel, thereby overcoming problems of compliance mismatch.

Claims

1. A vascular graft prosthesis comprising:

an elastomeric polymeric tubular structure having a wall; and

helically oriented, interconnected transmural ingrowth tubular channels formed from extractable fiber in the tube wall.

2. The vascular graft prosthesis of claim 1 wherein the tubular structure has an internal diameter in a range of 1-20 mm.

3. The vascular graft prosthesis of claim 1 wherein the tubular structure has an internal diameter in a range of 2-6 mm.

4. The vascular graft prosthesis of claim 1 wherein the diameters of the channels are in a range of 10-300 μ

m.

5. The vascular graft prosthesis of claim 1 wherein the diameters of the channels are in a range of 40-110 μ

m.

6. The vascular graft prosthesis of claim 1 wherein the elastomeric polymeric tubular structure comprises polyurethane.

7. The vascular graft prosthesis of claim 1 wherein the elastomeric polymeric tubular structure comprises a segmented aliphatic polyurethane.

8. The vascular graft prosthesis of claim 1 wherein the elastomeric polymeric tubular structure comprises a material selected from the group consisting of Pellethane, Chronoflex, Hydrothane, Estane, Elast-Eon, Texin, Biomer, Surethane, Corethane, Carbothane, Techoflex, Tecothane and Biospan.

9. The vascular prosthesis of claim 1 wherein substantially all of the channels have diameters within 10 μ

m.

10. The vascular prosthesis of claim 1 wherein the elastomeric polymeric tubular structure comprises PTFE.

11. The vascular graft prosthesis of claim 1 wherein the elastomeric polymeric tubular structure comprises ePTFE.

12. The vascular graft prosthesis of claim 1 wherein the elastomeric polymeric tubular structure comprises Dacron.

13. The vascular graft prosthesis of claim 1 further comprising reinforcing fibers in the elastomeric polymeric tubular structure.

14. The vascular graft prosthesis of claim 13 wherein the reinforcing fibers have diameters in a range of 10 to 100 micrometers.

15. The vascular graft prosthesis of claim 13 wherein the fibers used to form the tube wall have diameters with a standard deviation of less than 20 micrometers.

16. The vascular graft prosthesis of claim 13 wherein the fibers used to form the tube wall have diameters with a standard deviation of less than 10 micrometers.

17. The vascular graft prosthesis of claim 13 wherein the reinforcing fibers comprise an elastic, non-degradable material.

18. The reinforcing fibers of claim 17 further comprising a material degradable in vivo.

19. The vascular graft prosthesis of claim 13 wherein the reinforcing fibers comprise a non-elastic, non-degradable material.

20. The reinforcing fibers of claim 19 further comprising a material degradable in vivo.

21. The reinforcing fibers of claim 19 further comprising an elastic, non-degradable material.

22. The reinforcing fibers of claim 21 further comprising a material degradable in vivo.

23. An aortic valve prosthesis comprising:

an elastomeric polymeric tubular structure having a wall; and

helically oriented, interconnected transmural ingrowth tubular channels formed from extractable fiber in the tube wall.