Claims
- 1. A composite multilayer implantable material comprising:
a first inner tubular layer formed of expanded polytetrafluoroethyene having a porous microstructure defined by nodes interconnected by fibrils, wherein said first layer has a plurality of pleated folds; a second tubular layer formed of textile material circumferentially disposed exteriorly to said first layer; and having an elastomeric bonding agent applied to one of said first layer or second layer for securing said first layer to said second layer.
- 2. The implantable material of claim 1 wherein said bonding agent is applied to one surface of said first layer.
- 3. The implantable material of claim 1 wherein said bonding agent is selected from the group consisting of urethanes, styrene/isobutylene/styrene block copolymers, silicones and combinations thereof.
- 4. The implantable material of claim 1 wherein said second layer comprises a textile pattern selected from the group comprising knits, weaves, stretch-knits, braids, any non-woven process, and combinations thereof.
- 5. The implantable material of claim 1 wherein said second layer is placed in contact with said one surface of said first layer.
- 6. The implantable material of claim 1 wherein said implantable material includes said first layer being a blood contact layer and said second layer being a tissue contacting layer.
- 7. The implantable material of claim 1 wherein said first, and second tubular layers form an elongate tubular vascular graft.
- 8. The implantable material of claim 7 wherein said graft includes a plurality of longitudinally spaced crimps therealong.
- 9. The implantable material of claim 7 wherein said graft is helically wrapped with a monofilament externally therearound.
- 10. The implantable material of claim 9 wherein said monofilament comprises polypropylene.
- 11. The implantable material of claim 10 wherein said monofilament is attached by heat bonding.
- 12. The implantable material of claim 9 wherein said graft includes an external support coil helically positioned thereover.
- 13. The implantable material of claim 1 wherein said elastomeric bonding agent is applied to said second layer in solution.
- 14. The implantable material of claim 13 wherein said solution includes dimethylacetamide.
- 15. The implantable material of claim 1, wherein the pleats are of uniform length.
- 16. The implantable material of claim 1, wherein the pleats are of variable length.
- 17. The implantable material of claim 1, wherein the pleats have uniform spacing.
- 18. The implantable material of claim 1, wherein the pleats have variable spacing.
- 19. A composite multilayer implantable structure comprising:
a first inner tubular layer formed of expanded polytetrafluoroethyene having a porous microstructure defined by nodes interconnected by fibrils, and a second tubular layer of expanded polytetrafluoroethyene circumferentially disposed exteriorly to said first layer, wherein said first and second layers have a plurality of pleated folds, and wherein said first and second layers having a support structure positioned therebetween, a third tubular layer formed of textile material circumferentially disposed exteriorly to said second layer; and an elastomeric bonding agent applied to one of said second layer or third layer for securing said second layer to said third layer.
- 20. A composite structure of claim 19 wherein said bonding agent is applied to one surface of said first layer.
- 21. A composite structure of claim 19 wherein said bonding agent is applied to a surface of said second textile layer.
- 22. A composite structure of claim 19 wherein said bonding agent is selected from the group consisting of urethanes, styrene/isobutylene/styrene block copolymers, silicones and combinations thereof.
- 23. A composite structure of claim 19 wherein said third layer comprises a textile pattern selected from the group comprising knits, weaves, stretch-knits, braids, any non-woven process, and combinations thereof.
- 24. A composite structure of claim 19 wherein said third layer is placed in contact with said one surface of said second layer.
- 25. A composite structure of claim 19 wherein said implantable structure includes said first layer being a blood contact layer and said third layer being a tissue contacting layer.
- 26. A composite structure of claim 19 wherein said first, second and third tubular layers form an elongate tubular vascular graft.
- 27. A composite structure of claim 26 wherein said graft includes a plurality of longitudinally spaced crimps therealong.
- 28. A composite structure of claim 26 wherein said graft is helically wrapped with a monofilament externally therearound.
- 29. A composite structure of claim 26 wherein said monofilament comprises polypropylene.
- 30. A composite structure of claim 29 wherein said monofilament is attached by heat bonding.
- 31. A composite structure of claim 28 wherein said graft includes an external support coil helically positioned thereover.
- 32. A composite structure of claim 19 wherein said elastomeric bonding agent is applied to said second layer in solution.
- 33. A composite structure of claim 32 wherein said solution includes dimethylacetamide.
- 34. A composite structure of claim 19 further comprising a fourth tubular layer formed of textile material circumferentially disposed interiorly to said first and second layers; and
an elastomeric bonding agent applied to one of said first layer or said fourth layer for securing said first layer to said fourth layer.
- 35. The implantable material of claim 19, wherein the pleated folds are of uniform length.
- 36. The implantable material of claim 19, wherein the pleated folds are of variable length.
- 37. The implantable material of claim 19, wherein the pleated folds have uniform spacing.
- 38. The implantable material of claim 19, wherein the pleated folds have variable spacing.
- 39. A method of forming a textile ePTFE composite graft material comprising:
providing a first tubular ePTFE structure having a microporous structure of nodes interconnected by fibrils; providing a second tubular ePTFE structure having a microporous structure of nodes interconnected by fibrils; folding a plurality of pleats into said first tubular ePTFE structure and said second tubular ePTFE structure; providing a tubular textile structure; placing a tubular support structure circumferentially around said first ePTFE tubular structure; placing said second tubular ePTFE structure circumferentially around said tubular support structure; applying a coating of an elastomeric bonding agent to a surface of said second ePTFE structure or said textile structure; and securing said second ePTFE structure to said textile structure.
- 40. A method of claim 39 wherein said tubular textile structure defines an inner and outer surface.
- 41. A method of claim 40 wherein said first and second ePTFE tubular structures are applied to said inner surface of said textile structure.
- 42. A method of claim 39 wherein said bonding agent is applied to one surface of said second ePTFE structure.
- 43. A method of claim 42 wherein said bonding agent is selected from the group consisting of urethanes, styrene/isobutylene/styrene block copolymers, silicones, and combinations thereof.
- 44. A method of claim 39 wherein said textile structure is formed by a process selected from the group consisting of knitting, weaving, stretch-knitting, braiding, any non-woven process, and combinations thereof.
- 45. A method of claim 39 wherein said elastomeric bonding agent is applied to said one surface in solution.
- 46. A method of claim 45 wherein said solution includes dimethylacetamide.
- 47. A method of claim 39 further comprising the following steps:
applying an elastomeric bonding agent to an interior surface of said first ePTFE tubular structure; placing a fourth tubular structure formed of textile material circumferentially interior to said first and second ePTFE tubular layers;and bonding said layers together.
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation in part of application Ser. No. 10/166,842, filed Jun. 11, 2002, which claims priority to U.S. Provisional Application No. 60/297,401, both of which are incorporated by reference herein.
Provisional Applications (1)
|
Number |
Date |
Country |
|
60297401 |
Jun 2001 |
US |
Continuation in Parts (1)
|
Number |
Date |
Country |
Parent |
10166842 |
Jun 2002 |
US |
Child |
10643315 |
Aug 2003 |
US |