Methods for making a supported graft

• US 7,060,150 B2
• Filed: 05/08/2003
• Issued: 06/13/2006
• Est. Priority Date: 03/10/1995
• Status: Expired due to Fees

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Original Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Inventors: Edwin, Tarun J., McCrea, Brendan, Kowligi, Rajagopal R., Banas, Chris
• Primary Examiner(s): Aftergut, Jeff H.
• Application Number:
  US10/431,685
• Publication Number:
  US 20030201058A1
• Time in Patent Office: 1,132 Days
• Field of Search: 156/169, 156/173, 156/175, 156/184, 156/191, 156/192, 156/195, 156/309.6, 156/308.2
• US Class Current: 156/184
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• 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 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• 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: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30448 using adhesives
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene

Abstract

A method for making an endoluminal prosthesis for implantation within a body lumen to maintain luminal patency, the prothesis including a support structure, such as a wire member, and a polymer component, such as a polymer cladding. The method may include joining a wire member to a polymer cladding, helically wrapping a length of the joined support wire member and polymer cladding such that adjacent windings of the polymer cladding have overlapping regions, and heating the joined support wire member and polymer cladding above the melt point of the polymer cladding.

Claims

1. A method for making an endoluminal prosthesis, comprising:

joining an elongate support wire member to a polymer cladding;

helically wrapping a length of the joined support wire member and polymer cladding such that adjacent windings of the polymer cladding have overlapping regions;

heating the joined support wire member and polymer cladding above the melt point of the polymer cladding, wherein the wire member and polymer cladding together form a generally tubular structure having a first diameter; and

manipulating the generally tubular structure to a second diameter smaller than the first diameter.

2. The method according to claim 1, wherein the joining comprises completely surrounding the wire member with the polymer cladding.

3. The method according to claim 2, wherein the joining comprises coextruding the support wire member with the polymer cladding.

4. The method according to claim 2, wherein the joining comprises extruding the polymer cladding with a central lumen dimensioned to receive the support wire member and threading the support wire member into said central lumen.

5. The method according to claim 1, wherein the joining comprises extruding the polymer cladding with a longitudinally extending recess dimensioned to receive and retain the support wire member and placing the support wire member into said longitudinally extending recess.

6. The method according to claim 1, wherein the joining comprises dip-coating the support wire member, wherein the polymer cladding is in solvent or aqueous form, and drying the polymer cladding.

7. The method according to claim 1, wherein the joining comprises spraying the support wire member with the polymer cladding in solvent or aqueous form and drying the polymer cladding.

8. The method according to claim 1, further comprising encapsulating said joined support wire member and polymer cladding between an outer and an inner tabular substrate.

9. The method according to claim 1, further comprising selecting the polymer cladding material from the group consisting of polytetrafluoroethylene, polyurethane, polyethylene, polypropylene, polyamide, polyimide, polyester, polyfluoroethylenes, silicone, fluorinated polyolefin, fluorinated ethylene/propylene copolymer, perfluoroalkoxy fluorocarbon, ethylene/tetrafluoroethylene copolymer, polyvinylpyrrolidone, and combinations thereof.

10. The method according to claim 1, wherein the elongate support wire member is made of shape memory alloy, further comprising:

winding the wire member about a shaping mandrel;

imparting shape memory characteristics to the wire member by heating at a temperature where the austenite phase of the shape memory alloy is stable;

cooling the wire member to a temperature where the martensite phase of the shape memory alloy is stable; and

straightening the wire member for joining to the polymer cladding.

11. The method according to claim 1, wherein manipulating comprises mechanically deforming the generally tubular substrate.

12. The method according to claim 1, wherein manipulating comprises drawing the generally tubular substrate through a die.

13. The method according to claim 1, wherein manipulating comprises folding the generally tubular substrate.

14. The method according to claim 1, further comprising loading the generally tubular substrate into a restraining sheath, wherein the restraining sheath prevents the generally tubular substrate from reverting to the first diameter.

15. The method according to claim 1, further comprising sterilizing the generally tubular substrate.

16. The method according to claim 15, wherein sterilizing comprises exposing the generally tubular substrate to ethylene oxide.