Implantable devices with reduced needle puncture site leakage

• US 20060118236A1
• Filed: 11/29/2004
• Published: 06/08/2006
• Est. Priority Date: 11/29/2004
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Cully, Edward H., Pond, Daniel B., House, Wayne D.
• Granted Patent: US 8,029,563 B2
• Time in Patent Office: Days
• US Class Current: 156/294
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/34 Macromolecular 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 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: B29C 35/02 Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mouldcold vulcanisation B29C35/18 ; vulcanising tyres, presses therefor B29D30/0601
• CPC Class Codes: B29C 41/08 Coating a former, core or other substrate by spraying or fluidisation, e.g. spraying powder spray-up of reinforcing fibres B29C70/305
• CPC Class Codes: B29C 63/18 using tubular layers or sheathings B29C63/26 and B29C63/38 take precedence; placing tubular labels around rigid containers B65C3/065
• CPC Class Codes: B29C 66/344 Stretching or tensioning the joint area during joining
• CPC Class Codes: B29D 23/001 Pipes; Pipe joints pleated hoses B29D23/18
• CPC Class Codes: B29K 2021/00 Use of unspecified rubbers as moulding material
• CPC Class Codes: B29K 2027/18 PTFE, i.e. polytetrafluorethene , e.g. ePTFE, i.e. expanded polytetrafluorethene
• CPC Class Codes: B29K 2105/246 Uncured, e.g. green
• CPC Class Codes: B29L 2009/00 Layered products
• CPC Class Codes: B29L 2023/007 Medical tubes other than catheters catheters B29L2031/7542
• CPC Class Codes: B32B 1/08 Tubular products
• CPC Class Codes: B32B 2250/03 3 layers
• CPC Class Codes: B32B 2250/24 All layers being polymeric
• CPC Class Codes: B32B 2250/40 Symmetrical or sandwich layers, e.g. ABA, ABCBA, ABCCBA
• CPC Class Codes: B32B 2264/105 Metal
• CPC Class Codes: B32B 2307/546 : Flexural strength; Flexion stiffness
• CPC Class Codes: B32B 2307/722 : Non-uniform density
• CPC Class Codes: B32B 2307/762 : Self-repairing, self-healing
• CPC Class Codes: B32B 25/08 : of synthetic resin
• CPC Class Codes: B32B 25/20 : comprising silicone rubber
• CPC Class Codes: B32B 2535/00 : Medical equipment, e.g. bandage, prostheses, catheter medical patches B32B2556/00
• CPC Class Codes: B32B 2597/00 : Tubular articles, e.g. hoses, pipes
• CPC Class Codes: B32B 27/00 : Layered products comprising a layer of synthetic resin fibrous or filamentary layer made of a synthetic resin B32B5/02; particulate layer made of a synthetic resin B32B5/16; foamed layer made of a synthetic resin B32B5/18
• CPC Class Codes: B32B 27/08 : of synthetic resin
• CPC Class Codes: B32B 27/16 : specially treated, e.g. irradiated
• CPC Class Codes: B32B 27/18 : characterised by the use of special additives
• CPC Class Codes: B32B 27/304 : comprising vinyl halide (co)polymers, e.g. PVC, PVDC, PVF, PVDF
• CPC Class Codes: B32B 27/322 : comprising halogenated polyolefins, e.g. PTFE
• CPC Class Codes: B32B 27/40 : comprising polyurethanes
• CPC Class Codes: B32B 3/26 : characterised by a particular shape of the outline of the cross-section of a continuous layer; characterised by a layer with cavities or internal voids foam layer B32B5/18; layer of synthetic resin characterised by fillers that create voids or cavities B32B27/205; characterised by an apertured layer
• CPC Class Codes: B32B 5/142 : Variation across the area of the layer
• CPC Class Codes: C08L 27/18 : Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: F16L 11/04 : made of rubber or flexible plastics

Abstract

A prosthetic implantable device that offers a reduction in fluid loss when the device is punctured, such as by a dialysis needle or suture needle, and the needle is subsequently removed. The device may be made to be thin and flexible, and with longitudinal stretch, in order that it also offers good handling and kink resistance to a surgeon. While the device is preferably of tubular form, flat sheets or other forms may also be made. The device includes inner and outer layers of a porous material having a microstructure of nodes interconnected by bent fibrils, and having void spaces between adjacent bent fibrils. The inner and outer layers are joined by an elastomeric adhesive that may interpenetrate the void spaces of the adjacent surfaces of the inner and outer layers, that is, the inner surface of the outer layer and the outer surface of the inner layer. Optionally, a middle layer of an elastomeric material may also be provided, joined to the inner and outer porous layers by the interpenetrating elastomeric adhesive. The device is preferably a vascular graft and more preferably a vascular graft for kidney dialysis.

Claims

1. An implantable device comprising:

a.) an inner layer of porous material having a microstructure of nodes and fibrils wherein a substantial portion of said fibrils are in a bent configuration;

b.) a middle layer of an elastomeric material; and

c.) an outer layer of porous material having a microstructure of nodes and fibrils wherein a substantial portion of said fibrils are in a bent configuration.

2. An implantable device according to claim 1 wherein said device is tubular.

3. An implantable device according to claim 1 wherein at least one of said inner and outer layers comprise expanded polytetrafluoroethylene.

4. An implantable device according to claim 3 wherein said device is tubular.

5. An implantable device according to claim 4 wherein at least one of said inner and outer layers is provided with a helical wrap of expanded polytetrafluoroethylene film about at least a portion of an outer surface of said layer.

6. An implantable device according to claim 4 wherein said elastomeric material comprises silicone.

7. An implantable device according to claim 4 wherein said elastomeric material comprises polyurethane.

8. An implantable device according to claim 4 wherein said elastomeric material comprises a fluoroelastomer.

9. An implantable device according to claim 4 wherein said device further comprises nitinol.

10. An implantable device according to claim 4 wherein said inner and outer layers of porous material each have a thickness and said elastomer extends into void spaces of the porous material for a portion of said thickness.

11. An implantable device according to claim 4 wherein said inner and outer layers each has a length and at least one of said inner and outer layers has regions of higher density alternating with regions of lower density alternating along said length.

12. An implantable device according to claim 4 wherein at least one of said inner and outer layers comprises expanded polytetrafluoroethylene film.

13. An implantable device according to claim 1 wherein said elastomeric material comprises silicone.

14. An implantable device according to claim 1 wherein said elastomeric material comprises polyurethane.

15. An implantable device according to claim 1 wherein said elastomeric material comprises a fluoroelastomer.

16. An implantable device according to claim 1 wherein said device further comprises nitinol.

17. An implantable device according to claim 1 wherein said inner and outer layers of porous material each has a thickness and said elastomer extends into void spaces of the porous material for a portion of said thickness.

18. An implantable device according to claim 1 wherein said inner and outer layers each has a length and at least one of said inner and outer layers has regions of higher density alternating with regions of lower density along said length.

19. A tubular implantable device comprising first and second tubes having inner and outer surfaces and a microstructure including fibrils between the inner and outer surfaces, wherein said second tube is arranged concentrically around said first tube, wherein the outer surface of said first tube and the inner surface of said second tube are adhered with an elastomeric material, and wherein at least a substantial portion of the fibrils of the first and second tubes are in a bent configuration.

20. A tubular implantable device according to claim 19 wherein at least one of said first and second tubes comprises expanded polytetrafluoroethylene.

21. A tubular implantable device according to claim 20 wherein at least one of said first and second tubes is provided with a helical wrap of expanded polytetrafluoroethylene film about at least a portion of the outer surface of said tube.

22. A tubular implantable device according to claim 20 wherein said elastomeric material comprises silicone.

23. A tubular implantable device according to claim 20 wherein said elastomeric material comprises polyurethane.

24. A tubular implantable device according to claim 20 wherein said elastomeric material comprises a fluoroelastomer.

25. A tubular implantable device according to claim 20 wherein said first and second tubes each has a thickness and said elastomer extends into void spaces of the microstructure for a portion of said thickness.

26. A tubular implantable device according to claim 20 wherein said first and second tubes each has a length and at least one of said first and second tubes has regions of higher density alternating with regions of lower density along said length.

27. A tubular implantable device according to claim 20 wherein at least one of said inner and outer layers comprises expanded polytetrafluoroethylene film.

28. A tubular implantable device according to claim 19 wherein said elastomeric material comprises silicone.

29. A tubular implantable device according to claim 19 wherein said elastomeric material comprises polyurethane.

30. A tubular implantable device according to claim 19 wherein said elastomeric material comprises a fluoroelastomer.

31. A tubular implantable device according to claim 19 wherein said first and second tubes each has a thickness and said elastomer extends into void spaces of the microstructure for a portion of said thickness.

32. The tubular implantable device of claim 19 wherein a tubular layer of elastomeric material is located between the outer surface of the first tube and the inner surface of the second tube.

33. A tubular implantable device according to claim 32 wherein at least one of said first and second tubes comprises expanded polytetrafluoroethylene.

34. A tubular implantable device according to claim 33 wherein at least one of said first and second tubes is provided with a helical wrap of expanded polytetrafluoroethylene film about at least a portion of the outer surface of said tube.

35. A tubular implantable device according to claim 33 wherein said tubular layer of elastomeric material comprises silicone.

36. A tubular implantable device according to claim 33 wherein said tubular layer of elastomeric material comprises polyurethane.

37. A tubular implantable device according to claim 33 wherein said tubular layer of elastomeric material comprises a fluoroelastomer.

38. A tubular implantable device according to claim 33 wherein said tubular layer of elastomeric material comprises nitinol.

39. A vascular graft for dialysis comprising at least two layers of expanded polytetrafluoroethylene with an elastomeric material between the two layers of expanded polytetrafluoroethylene, the vascular graft having a bend radius of 30 mm without kinking, wherein the vascular graft is adapted for cannulation with a dialysis needle within 48 hours after implantation.

40. A vascular graft according to claim 39 wherein the vascular graft is adapted for cannulation with a dialysis needle within 24 hours after implantation.

41. A vascular graft according to claim 39 having a bend radius of 25 mm without kinking, wherein the vascular graft is adapted for cannulation with a dialysis needle within 48 hours after implantation.

42. A vascular graft according to claim 41 wherein the vascular graft is adapted for cannulation with a dialysis needle within 24 hours after implantation.

43. A vascular graft according to claim 39 having a bend radius of 20 mm without kinking, wherein the vascular graft is adapted for cannulation with a dialysis needle within 48 hours after implantation.

44. A vascular graft according to claim 43 wherein the vascular graft is adapted for cannulation with a dialysis needle within 24 hours after implantation.

45. A vascular graft according to claim 39 having a bend radius of 17 mm without kinking, wherein the vascular graft is adapted for cannulation with a dialysis needle within 48 hours after implantation.

46. A vascular graft according to claim 45 wherein the vascular graft is adapted for cannulation with a dialysis needle within 24 hours after implantation.

47. A vascular graft according to claim 39 having a bend radius of 15 mm without kinking, wherein the vascular graft is adapted for cannulation with a dialysis needle within 48 hours after implantation.

48. A vascular graft according to claim 47 wherein the vascular graft is adapted for cannulation with a dialysis needle within 24 hours after implantation.

49. A vascular graft for dialysis comprising at least two layers of expanded polytetrafluoroethylene with an elastomeric material between the two layers of expanded polytetrafluoroethylene, the expanded polytetrafluoroethylene having a microstructure of substantially bent fibrils, wherein the vascular graft is adapted for cannulation with a dialysis needle within 48 hours after implantation.

50. A vascular graft according to claim 49 wherein the vascular graft is adapted for cannulation with a dialysis needle within 24 hours after implantation.

51. A method of making a tubular implantable device comprising:

a) providing first and second expanded polytetrafluoroethylene tubes, said tubes having outer surfaces;

b) fitting said first expanded polytetrafluoroethylene tube over a mandrel with a slight interference fit;

c) coating at least a portion of the outer surface of said first tube with an elastomeric material;

d) fitting said second expanded polytetrafluoroethylene tube over the coated surface of said first tube;

e) longitudinally compressing said first and second expanded polytetrafluoroethylene tubes;

f) curing said elastomeric material; and

g) removing said first and second tubes from said mandrel.

52. A method of making a tubular implantable device comprising:

a) providing first and second tubes of expanded polytetrafluoroethylene, said tubes having outer surfaces;

b) providing an elastomeric tube having an outer surface;

c) fitting said first tube of expanded polytetrafluoroethylene over a mandrel with a slight interference fit;

d) coating at least a portion of the outer surface of said first tube with an elastomeric material;

e) fitting said elastomeric tube over the first expanded polytetrafluoroethylene tube;

f) applying tension longitudinally to said elastomeric tube and restraining both ends of said elastomeric tube to maintain said elastomeric tube in a state of tension;

g) coating at least a portion of the outer surface of said elastomeric tube with an elastomeric material;

h) fitting said second expanded polytetrafluoroethylene tube over the coated surface of said elastomeric tube;

i) curing said elastomeric material; and

j) removing all three tubes from said mandrel and trimming both ends of the resulting tubular implantable device.