Composite ePTFE/textile prosthesis

• US 20060264138A1
• Filed: 06/13/2006
• Published: 11/23/2006
• Est. Priority Date: 06/11/2001
• Status: Abandoned Application

• Current Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Sowinski, Krzysztof, Kujawski, Dennis, Rakos, Ronald, Dong, Jerry
• Application Number:
  US11/451,789
• Publication Number:
  US 20060264138A1
• Time in Patent Office: Days
• US Class Current: 442/315
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• 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 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: B32B 1/08 Tubular products
• CPC Class Codes: B32B 27/08 of synthetic resin
• CPC Class Codes: B32B 5/022 Non-woven fabric
• CPC Class Codes: B32B 5/024 Woven fabric
• CPC Class Codes: B32B 5/026 Knitted fabric
• CPC Class Codes: B32B 5/245 another layer next to it being a foam layer
• CPC Class Codes: B32B 7/12 using interposed adhesives or interposed materials with bonding properties
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: Y10T 428/1362 : Textile, fabric, cloth, or pile containing [e.g., web, net, woven, knitted, mesh, nonwoven, matted, etc.]
• CPC Class Codes: Y10T 428/1369 : Fiber or fibers wound around each other or into a self-sustaining shape [e.g., yarn, braid, fibers shaped around a core, etc.]
• CPC Class Codes: Y10T 428/1393 : Multilayer [continuous layer]
• CPC Class Codes: Y10T 428/249985 : Composition of adhesive or bonding component specified
• CPC Class Codes: Y10T 442/3325 : Including a foamed layer or component
• CPC Class Codes: Y10T 442/469 : Including a foamed layer or component
• CPC Class Codes: Y10T 442/647 : Including a foamed layer or component

Abstract

A composite intraluminal prosthesis which is preferably used as a vascular prothesis includes a layer of ePTFE and a layer of textile material which are secured together by an elastomeric bonding agent. The ePTFE layer includes a porous microstructure defined by nodes interconnected by fibrils. The adhesive bonding agent is preferably applied in solution so that the bonding agent enters the pores of the microstructure of the ePTFE. This helps secure the textile layer to the ePTFE layer.

Claims

1. A composite multilayer implantable structure comprising:

a first layer formed of textile material;

a second layer formed of expanded polytetrafluoroethyene having a porous microstructure defined by nodes interconnected by fibrils; and

an elastomeric bonding agent applied to one of said layers and disposed within the pores of said microstrcture for securing said first layer to said second layer.

2. A composite structure of claim 1 wherein said bonding agent is applied to one surface of said second layer.

3. A composite structure of claim 1 wherein said bonding agent is selected form the group consisting of urethanes, styrene/isobutylene/styrene block copolymers, silicones and combinations thereof.

4. A composite structure of claim 1 wherein said first layer comprises a textile pattern selected from the group comprising knits, weaves, stretch-knits, braids, non-woven textile structures and combinations thereof.

5. A composite structure of claim 2 wherein said first layer is placed in contact with said one surface of said second layer.

6. A composite structure of claim 1 wherein said first and second layers are substantially planar.

7. A composite structure of claim 6 wherein said first and second planar layers form a vascular patch.

8. A composite structure of claim 7 wherein said vascular patch includes said first layer being a blood contact layer and said second layer being a tissue contacting layer.

9. A composite structure of claim 1 wherein said first and second layers are substantially tubular.

10. A composite structure of claim 9 wherein said first and second tubular layers form an elongate tubular vascular graft.

11. A composite structure of claim 10 wherein said vascular graft has an inner blood-contacting second layer and an outer tissue-contacting first layer.

12. A composite structure of claim 10 wherein said vascular graft has an inner blood-contacting textile layer and an outer tissue-contacting non-textile layer.

13. A composite structure of claim 10 wherein said graft includes a plurality of longitudinally spaced crimps therealong.

14. A composite structure of claim 10 wherein said graft is helically wrapped with a monofilament externally therearound.

15. A composite structure of claim 14 wherein said monofilament comprises polypropylene.

16. A composite structure of claim 15 wherein said monofilament is attached by heat bonding.

17. A composite structure of claim 10 wherein said graft includes an external support coil helically positioned thereover.

18. A composite structure of claim 10 wherein said graft includes a support coil helically positioned between said first and second tubular layers.

19. A composite structure of claim 10 wherein said elastomeric bonding agent is self-sealing.

20. A composite structure of claim 10 wherein said composite tubular structure is longitudinally compressed.

21. A composite structure of claim 10 wherein said vascular graft has enhanced tear-resistant characteristics.

22. A composite structure of claim 1 wherein said textile material comprises PET and the elastomeric bonding agent is a polycarbonate urethane.

23. A composite structure of claim 1 wherein said composite structure further comprises a third layer.

24. A composite structure of claim 23 wherein said third layer is positioned adjacent said second layer.

25. A composite structure of claim 24 wherein said third layer is ePTFE.

26. A composite structure of claim 23 wherein said third layer is positioned said adjacent said first layer.

27. A composite structure of claim 26 wherein said third layer is formed of textile material.

28. A composite structure of claim 1 wherein said elastomeric bonding agent is applied to said second layer in solution.

29. A composite structure of claim 28 wherein said solution includes dimethylacetamide.

30. A composite structure of claim 1 wherein said bonding agent is a solid tubular structure.

31. A composite structure of claim 1 wherein said bonding agent is a powder.

32. A composite structure of claim 1 wherein said bond agent is applied by thermal processing means.

42. A composite structure of claim 1 wherein said bonding agent is a polycarbonate urethane having a Shore hardness from about 75 A to about 85 A and which is a reaction product of polyhexamethylenecarbonate diol, methylene bisphenyl diisocyanate and 1,4-butanediol.

43. A composite structure of claim 42 wherein said bonding agent includes a solvent.

45. A composite structure of claim 1 wherein said bonding agent is a styrene/isobutylene/styrene block copolymer.

46. A composite structure of claim 45 wherein said bonding agent includes a solvent.

47. A composite structure of claim 46 wherein said solvent is removed from said bonding agent prior to bonding said layers.

48. A composite structure of claim 20 wherein said composite tubular structure is longitudinally compressed in the axial direction to between 1% to 85% of its length to coil the fibrils of the ePTFE.

33. A method of forming a vascular prosthesis comprising the steps of:

forming an ePTFE layer having opposed surfaces comprising a microporous structure of nodes interconnected by fibrils;

forming a textile layer having opposed surfaces;

applying a coating of an elastomeric bonding agent to one of said opposed surfaces; and

securing said ePTFE and said textile layer together with said bonding agent being disposed in said microporous structure.

34. A method of claim 33 wherein said applying step includes:

applying a solution of said bonding agent.

35. A method of claim 34 wherein said applying step further includes:

spray coating said surface of said ePTFE with said solution.

49. A method of claim 33 wherein said bonding agent is a polycarbonate urethane having a Shore hardness from about 75 A to about 85 A and which is a reaction product of polyhexamethylenecarbonate diol, methylene bisphenyl diisocyanate and 1,4-butanediol.

50. A method of claim 49 wherein the polycarbonate urethane comprises a solvent.

51. A method of claim 50 wherein the step of securing further comprises heating the layers to a temperature of about 18°

C. to about 150°

C. to remove the solvent and heating the layers 180°

C. to about 220°

C. to bond the layers.

52. A method of claim 34 wherein the step of securing further comprises heating the layers to a temperature of about 18°

C. to about 150°

C. to dry off the solution and heating the layers 180°

C. to about 220°

C. to bond the layers.

53. A method of claim 33 wherein said bonding agent is a styrene/isobutylene/styrene block copolymer.

36. A method of forming a textile ePTFE composite graft comprising:

providing a tubular textile structure having opposed surfaces;

providing a tubular ePTFE liner structure having opposed surfaces and having a microporous structure of nodes interconnected by fibrils;

applying a coating of an elastomeric bonding agent to one of said opposed surfaces; and

securing said textile structure and said ePTFE liner structure with said bonding agent being present in mircropores of said microporous structure.

37. A method of claim 36 wherein said tubular textile structure defines an inner and outer surface.

38. A method of claim 37 wherein said ePTFE liner structure is applied to said outer textile surface.

39. A method of claim 37 wherein said ePTFE liner structure is applied to said inner textile surface.

40. A method of forming a textile covered ePTFE graft, comprising the steps of:

providing an ePTFE tube having a microporous structure of nodes interconnected by fibrils;

applying a coating of an elastomeric bonding agent to a surface of said ePTFE tube with said bonding agent being disposed within said micropores thereof; and

securing a textile tube to said coated surface of said ePTFE tube.

41. A method of forming a composite implantable patch comprising the steps of:

providing an elongate planar ePTFE substrate, said substrate having a microporous structure defined by nodes interconnected by fibrils;

applying a coating of an elastomeric bonding agent to one surface of said ePTFE substrate, said bonding agent being disposed within said micropores thereof; and

securing an elongate planar textile substrate to said coated surface of said ePTFE substrate.

44. A composite structure of claim 44 wherein said solvent is removed from said bonding agent prior to bonding said layers.