Coupling device and method of use

• US 5,728,131 A
• Filed: 06/12/1995
• Issued: 03/17/1998
• Est. Priority Date: 06/12/1995
• Status: Expired due to Term

• Current Assignee: Endotex Interventional Systems Incorporated (Boston Scientific Corporation)
• Original Assignee: Endotex Interventional Systems Incorporated (Boston Scientific Corporation)
• Inventors: Orth, Geoffrey A., Frantzen, John J.
• Primary Examiner(s): Schmidt, Jeffrey A.
• Application Number:
  US08/489,650
• Time in Patent Office: 1,009 Days
• Field of Search: 606/191, 606/192, 606/194, 606/200, 606/151, 623/1, 623/11, 623/12
• US Class Current: 623/1.13
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/30172 T-shaped
• CPC Class Codes: A61F 2002/30217 hollow cones, e.g. tubular-like cones
• CPC Class Codes: A61F 2002/30233 Stepped cylinders, i.e. having discrete diameter changes
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30329 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2002/30354 Cylindrically-shaped protrusion and recess, e.g. cylinder of circular basis
• CPC Class Codes: A61F 2002/30461 sutured, ligatured or stitched
• CPC Class Codes: A61F 2002/30589 Sealing means
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0033 : made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0052 : T-shaped
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2240/001 : Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0069 : Sealing means

Abstract

A coupler is provided for connecting a stent and a vascular graft for repairing aneurysms. An intravascular stent is connected to a vascular graft by a coupler having a high degree of elasticity so that the stent-coupler-graft assembly can be implanted to repair a body passageway, including aortic aneurysms.

Claims

1. An assembly for connecting a stent and a vascular graft, comprising:

an intravascular stent that is expandable from a delivery diameter to an implanted diameter;

a vascular graft having a folded diameter approximating said delivery diameter of said stent, and having an unfolded diameter approximating said implanted diameter of said stent;

a flexible coupler having a first end attached to said stent and a second end attached to said graft, said stent, said graft and said coupler forming a stent-coupler graft assembly that remains connected during delivery through a body lumen,

wherein said stent-coupler-graft assembly has a substantially uniform reduced profile formed by contracting said stent and folding said graft, said stent-coupler-graft assembly remaining connected after deployment of said stent to said implanted diameter and said graft to said unfolded diameter, with no portion of said graft overlapping said stent.

2. The assembly of claim 1, wherein said coupler is funnel-shaped.

3. The assembly of claim 2, wherein said first end of said coupler is expandable up to a diameter of approximately 0.800 inches, and said second end of said coupler is unexpanded and at rest at a diameter of approximately 0.800 inches.

4. The assembly of claim 1, wherein said coupler material can elongate up to 500%.

5. The assembly of claim 1, wherein said coupler is made from a biocompatible material.

6. The assembly of claim 5, wherein said coupler is made from highly elastic materials, taken from the group of elastic materials of polyurethane, silicone copolymers, latex, and polyseloxane modified ethylene/butylene-styrene block copylymers (SEB'"'"'s).

7. The assembly of claim 1, wherein said coupler has a wall thickness in the range of 0.0003 inches to 0.010 inches.

8. The assembly of claim 1, wherein said coupler provides a fluid-tight seal between said stent and said graft.

9. The assembly of claim 1, wherein said graft is bonded to said second end of said coupler.

10. The assembly of claim 1, wherein said stent is bonded to said first end of said coupler.

11. The assembly of claim 1, wherein said stent has a plurality of T-members extending from one end, said T-members being adapted for attachment to said first end of said graft.

12. The assembly of claim 1, wherein said first end of said coupler is sutured to said stent, and said second end of said coupler is attached to said graft by a dipping process.

13. The assembly of claim 1, wherein a plurality of fibers are woven into said coupler, said fibers extending from said first end and from said second end of said coupler, wherein said fibers extending from said first end are attached to said stent, and said fibers extending from said second end are attached to said graft.

14. The assembly of claim 13, wherein said fibers are made from a suture material.

15. The assembly of claim 14, wherein said fibers are bonded to said stent and said graft.

16. A method of repairing a body passageway, including an intravascular stent that is expandable from a first, delivery diameter to a second, implanted diameter, a vascular graft having a diameter approximating said implanted diameter of said stent, and a flexible coupler adapted to attach said intravascular stent and said vascular graft to form a stent-coupler-graft assembly, the method comprising:

attaching said stent to one end of said coupler and attaching said graft to the opposite end of said coupler;

mounting the stent-coupler-graft assembly on a balloon catheter;

reducing the profile of the stent-coupler-graft assembly to a first diameter by crimping said stent onto the balloon portion of said catheter, and folding said graft onto said catheter, to reduce the overall profile so that said stent-coupler-graft assembly has a substantially uniform first delivery diameter;

inserting said stent-coupler-graft assembly on said balloon catheter assembly percutaneously and transporting through the body passageway;

deploying said stent-coupler-graft assembly by expanding said stent to an enlarged, second diameter and unfolding said graft; and

withdrawing said balloon catheter assembly from the body passageway.

17. The method of claim 16, wherein said coupler expands up to 500% when said stent is expanded.

18. The method of claim 16, wherein said stent and said graft remain spaced apart during delivery and implanting of said stent-coupler-graft assembly.