Implantable devices with reduced needle puncture site leakage

• US 8,029,563 B2
• Filed: 11/29/2004
• Issued: 10/04/2011
• Est. Priority Date: 11/29/2004
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Enterprise Holdings Incorporated (W.L. Gore and Associates)
• Inventors: Pond, Daniel B., Cully, Edward H., House, Wayne D.
• Primary Examiner(s): Matthews; William H.
• Application Number:
  US10/999,276
• Publication Number:
  US 20060118236A1
• Time in Patent Office: 2,500 Days
• Field of Search: 623/1.1, 623/1.11, 623/1.13, 623/1.14, 623/1.18, 623/1.22, 623/1.23, 623/1.27, 623/1.32, 623/1.39, 623/1.4, 623 144 - 154
• US Class Current: 623/1.44
• 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 or catheter
• 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 with reduced needle puncture site leakage comprising:

a.) a longitudinally extruded and expanded inner tubular layer of porous material having a length and 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.) a longitudinally extruded and expanded outer tubular layer of porous material having a length and having a microstructure of nodes and fibrils wherein a substantial portion of said fibrils are in a bent configuration; and

wherein the fibrils of the inner and outer tubular layers are substantially parallel to each other and oriented in a direction substantially parallel to the lengths of the tubular layers.

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

3. An implantable device according to claim 2 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.

4. An implantable device according to claim 2 wherein said elastomeric material comprises silicone.

5. An implantable device according to claim 2 wherein said inner and outer layers of porous material each have a thickness and said elastomeric material extends into void spaces of the porous material of said inner and said outer layers for a portion of said thickness.

6. An implantable device according to claim 2 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 expanded polytetrafluoroethylene alternating with regions of lower density expanded polytetrafluoroethylene along said length.

7. An implantable device according to claim 2 wherein at least one of said inner and outer layers comprises expanded polytetrafluoroethylene film.

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

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

10. 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 expanded polytetrafluoroethylene alternating with regions of lower density expanded polytetrafluoroethylene along said length.

11. A tubular implantable device with reduced needle puncture site leakage comprising first and second longitudinally extruded and expanded tubes each having a length and 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;

and wherein the fibrils of the first and second tubes are substantially parallel to each other and oriented in a direction substantially parallel to the lengths of the first and second tubes.

12. A tubular implantable device according to claim 11 wherein at least one of said first and second tubes comprises expanded polytetrafluoroethylene.

13. A tubular implantable device according to claim 12 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.

14. A tubular implantable device according to claim 12 wherein said elastomeric material comprises silicone.

15. A tubular implantable device according to claim 12 wherein said first and second tubes each have a thickness and said elastomeric material extends into void spaces of the microstructure of said first and said second tubes for a portion of said thickness.

16. A tubular implantable device according to claim 12 wherein at least one of said first and second tubes has regions of higher density expanded polytetrafluoroethylene alternating with regions of lower density expanded polytetrafluoroethylene along said lengths of the first and second tubes.

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

18. A tubular implantable device according to claim 11 wherein said elastomeric material comprises silicone.

19. A tubular implantable device according to claim 11 wherein said first and second tubes each have a thickness and said elastomeric material extends into void spaces of the microstructure of said first and said second tubes for a portion of said thickness.