Endovascular prosthesis having a layer of biological tissue

• US 20030195608A1
• Filed: 04/09/2003
• Published: 10/16/2003
• Est. Priority Date: 07/19/2001
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Sarac, Timur Paul
• Granted Patent: US 7,137,947 B2
• Time in Patent Office: Days
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/062 Apparatus for the production of blood vessels made from natural tissue or with layers of living cells prostheses made from natural tissue or living cells A61L27/507
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• 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 31/005 Ingredients of undetermined constitution or reaction products thereof

Abstract

An apparatus (10) for grafting of a blood vessel (12) and a method of forming the apparatus (10) is provided. The apparatus (10) comprises an expandable support member (16) having inner and outer surfaces (36 and 34). The outer surface (34) of the expandable support member (16) is for engaging and adhering to an inside surface (68) of the blood vessel (12). A layer of biological tissue (14) is attached to the inner surface (36) of the support member (16). The layer of biological tissue (14) has an uninterrupted inwardly facing surface (50) for extending confluently with the inside surface (68) of the blood vessel (12) to provide resistance to thrombosis and platelet deposition.

Claims

1. An apparatus for grafting of a blood vessel, the blood vessel having an inside surface that defines a conduit for directing blood flow, said apparatus comprising:

an expandable support member having inner and outer surfaces, said outer surface for engaging and adhering to the inside surface of the blood vessel; and

a layer of biological tissue being attached to said inner surface of said support member, said layer of biological tissue having an uninterrupted inwardly facing surface for extending confluently with the inside surface of the blood vessel to provide resistance to thrombosis and platelet deposition as blood flows through the conduit.

2. The apparatus of claim 1 wherein said layer of biological tissue comprises an inner lining of a serous membrane.

3. The apparatus of claim 2 wherein said layer of biological tissue also comprises an outer layer of associated fascia, said inner layer of serous membrane being supported by said outer lining of associated fascia.

4. The apparatus of claim 3 wherein said inner lining of a serous membrane is selected from the group consisting of peritoneum, pleura, and pericardium.

5. The apparatus of claim 1 wherein said layer of biological tissue comprises a peritoneal membrane.

6. The apparatus of claim 1 wherein said layer of biological tissue comprises a pleural membrane.

7. The apparatus of claim 1 wherein said layer of biological tissue comprises a pericardial membrane.

8. The apparatus of claim 1 wherein said expandable support member comprises a fabric layer.

9. The apparatus of claim 1 wherein said expandable support member comprises a metallic stent.

10. The apparatus of claim 1 wherein said expandable support member comprises a layer of polytetraflouroethylene.

11. The apparatus of claim 1 wherein said expandable support member includes a plurality of eyelets for receiving a portion of a suture used for attaching said layer of biological tissue to said expandable support member.

12. The apparatus of claim 1 wherein said expandable support member includes a plurality of axially extending support rods.

13. The apparatus of claim 12 wherein said expandable support member further includes a plurality of eyelets for receiving a portion of a suture used for attaching said layer of biological tissue to said expandable support member, each eyelet being attached to an axially extending support rod.

14. The apparatus of claim 1 wherein said layer of biological tissue is provided by an autogenous graft.

15. The apparatus of claim 1 wherein said layer of biological tissue is provided by a cadaveric graft.

16. The apparatus of claim 1 wherein said layer of biological tissue is provided by a xenogeneic graft.

17. The apparatus of claim 1 wherein said layer of biological tissue forms a radially innermost component of said apparatus.

18. The apparatus of claim 17 wherein said layer of biological tissue includes first and second side surfaces, said first and second side surfaces abutting to form a seam.

19. The apparatus of claim 18 wherein said layer of biological tissue includes an inner surface and an outer surface, said outer surface of said layer of biological tissue being attached to said inner surface of said support member.

20. The apparatus of claim 19 wherein a layer of biological glue is applied over said outer surface of said layer of biological tissue at a location of said seam, said biological glue helping to prevent leakage through said seam.

21. The apparatus of claim 18 wherein said seam extend along an axial length of said layer of biological tissue.

22. An apparatus for grafting of a blood vessel, the blood vessel having an inside surface that defines a conduit for directing blood flow, said apparatus comprising:

an expandable support member having inner and outer surfaces, said outer surface for engaging and adhering to the inside surface of the blood vessel; and

a layer of tissue being attached to said inner surface of said support member, said layer of tissue having an uninterrupted inwardly facing surface for extending confluently with the inside surface of the blood vessel to provide resistance to thrombosis and platelet deposition as blood flows through the conduit.

23. The apparatus of claim 22 wherein said layer of tissue is a layer of biological tissue that is selected from the group consisting of peritoneum, pleura, and pericardium.

24. The apparatus of claim 22 wherein said layer of tissue is an artificial tissue that mimics the characteristics of biological tissue that is selected from the group consisting of peritoneum, pleura, and pericardium.

25. The apparatus of claim 24 wherein said artificial tissue is constructed from collagen scaffolding that is seeded with tissue cells.

26. The apparatus of claim 25 wherein said tissue cells comprise human keratinocytes.

27. The apparatus of claim 24 wherein said layer of tissue also includes a basement membrane.

28. The apparatus of claim 25 wherein said basement membrane is a fascia lining for supporting the collagen scaffolding.

29. An apparatus for grafting of a blood vessel, the blood vessel having an inside surface that defines a conduit for directing blood flow, said apparatus comprising:

a support member having first and second surfaces, one of said first and second surfaces for engaging and adhering to the inside surface of the blood vessel; and

a layer of biological tissue being attached to the other of said first and second surfaces of said support member, said layer of biological tissue having an uninterrupted inwardly facing surface for extending confluently with the inside surface of the blood vessel to provide resistance to thrombosis and platelet deposition as blood flows through the conduit;

said layer of biological tissue being selected from the group consisting of peritoneum, pleura, and pericardium.

30. The apparatus of claim 29 wherein said layer of biological tissue includes a serous membrane lining.

31. The apparatus of claim 30 wherein said layer of biological tissue further includes an associated fascia lining, said serous membrane lining forming a radially innermost component of said apparatus.

32. The apparatus of claim 31 wherein said layer of biological tissue includes first and second side surfaces that are abutted to form a seam, said layer of biological tissue having a tubular shape when said first and second side surfaces are abutted to form said seam.

33. The apparatus of claim 30 wherein said support member includes an outer frame and inner support beams, said outer frame supporting a peripheral portion of said layer of biological tissue and said inner support beams supporting an interior portion of said layer of biological tissue.

34. The apparatus of claim 33 wherein said outer frame has a shape that is similar to a shape of said layer of biological tissue.

35. A graft for a blood vessel, the blood vessel having an inside surface that defines a conduit for directing blood flow, said graft comprising a layer of biological tissue having an uninterrupted inwardly facing surface, said uninterrupted inwardly facing surface for extending confluently with the inside surface of the blood vessel to provide resistance to thrombosis and platelet deposition as blood flows through the conduit.

36. The graft of claim 35 wherein said layer of biological tissue is selected from the group consisting of peritoneum, pleura, and pericardium.

37. The graft of claim 35 further including an expandable support member, said expandable support member having an outer surface and an inner surface, said inner surface engaging and supporting said layer of biological tissue.

38. The graft of claim 37 wherein said expandable support member forms an outermost portion of said graft and wherein said layer of biological tissue forms an innermost component of said graft.

39. The graft of claim 38 wherein said layer of biological tissue is selected from the group consisting of peritoneum, pleura, and pericardium.

40. The graft of claim 38 wherein said layer of biological tissue is provided by one of an autogenous graft, a cadaveric graft, and a xenogeneic graft.

41. A graft for a blood vessel, the blood vessel having an inside surface that defines a conduit for directing blood flow, said graft consisting of a layer of biological tissue having an uninterrupted inwardly facing surface, said uninterrupted inwardly facing surface for extending confluently with the inside surface of the blood vessel to provide resistance to thrombosis and platelet deposition as blood flows through the conduit, said layer of biological tissue comprising an inner lining of a serous membrane supported by an outer lining of associated fascia.

42. A method for forming a graft for insertion in a blood vessel, the blood vessel having an inside surface that defines a conduit for directing blood flow, said method comprising the steps of:

providing an expandable support member having inner and outer surfaces, the outer surface for engaging and adhering to the inside surface of the blood vessel;

providing a layer of biological tissue having an uninterrupted inwardly facing surface for extending confluently with the inside surface of the blood vessel to provide resistance to thrombosis and platelet deposition as blood flows through the conduit;

molding the layer of biological tissue into a desired shape; and

attaching the layer of biological tissue to the inner surface of the support member.

43. The method of claim 42 the step of providing a layer of biological tissue having an uninterrupted inwardly facing surface includes the steps of:

harvesting said layer of biological tissue from the group consisting of peritoneum, pleura, and pericardium;

fixing said layer of biological tissue with a fixing agent; and

trimming said layer of biological tissue.

44. The method of claim 42 wherein the step of molding the layer of biological tissue into a desired shape includes the steps of:

providing a dowel having an outer surface with a cross-section having the desired shape; and

wrapping said layer of biological tissue around said outer surface of said dowel.

45. The method of claim 42 wherein the step of attaching the layer of biological tissue to the inner surface of the support member further includes the steps of:

inserting said layer of biological tissue into said support member; and

suturing said layer of biological tissue to said support member.

46. The method of claim 45 wherein the step of inserting said layer of biological tissue into said support member includes the steps of:

expanding said support member;

moving the support member relative to said layer of biological tissue until and equal amount of biological tissue extends from first and second ends of said support structure; and

constricting said support structure around said layer of biological tissue.

47. A method for preparing a patch for insertion in a blood vessel, the blood vessel having an inside surface that defines a conduit for directing blood flow, said method comprising the steps of:

harvesting a layer of biological tissue comprising an inner lining of a serous membrane supported by an outer lining of associated fascia, the inner lining of serous membrane having an uninterrupted inwardly facing surface for extending confluently with the inside surface of the blood vessel to provide resistance to thrombosis and platelet deposition as blood flows through the conduit;

molding the layer of biological tissue into a desired shape; and

packaging the layer of biological tissue in a sterile vacuum-packed container.