Method of making implantable devices with reduced needle puncture site leakage

• US 8,906,087 B2
• Filed: 09/30/2011
• Issued: 12/09/2014
• 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: House, Wayne D., Cully, Edward H., Pond, Daniel B.
• Primary Examiner(s): Matthews, Howie
• Application Number:
  US13/250,656
• Publication Number:
  US 20120058249A1
• Time in Patent Office: 1,166 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, 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.

Claims

1. 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;

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.

2. 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;

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 while said elastomeric tube remains in a state of tension;

i) curing said elastomeric material; and

j) removing all three tubes from said mandrel wherein the tension on the elastomeric tube is released resulting in the application of axial compression to the first and second expanded polytetrafluoroethylene tubes, and trimming both ends of the resulting tubular implantable device.