Implant deployment restraint device

• US 9,125,765 B2
• Filed: 12/12/2011
• Issued: 09/08/2015
• Est. Priority Date: 12/13/2010
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Melsheimer, Jeffry S.
• Primary Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US13/323,048
• Publication Number:
  US 20120150272A1
• Time in Patent Office: 1,366 Days
• Field of Search: 623/1.11
• US Class Current: 1/1
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: Y10T 29/49908 Joining by deforming

Abstract

A restraint member is provided for preventing longitudinal movement between a self-expanding medical implant and the inner catheter upon which the implant is mounted. The restraint member may be particularly useful for a woven wire self-expanding stent where the restraint member is positioned only under one or more ends of the stent.

Claims

1. A medical device, comprising:

an inner catheter comprising an outer diameter along a distal portion of said inner catheter;

a restraint member disposed on said inner catheter, said restraint member comprising an inner diameter, a hub extending from said inner diameter and around said restraint member, and a plurality of protrusions extending outward from an outer surface of said hub, each of said protrusions comprising a base at said outer surface of said hub and an outer end, said base being larger than said outer end, wherein said restraint member comprises a row of said protrusions around a circumference of said hub, said inner diameter of said restraint member being bonded to said inner catheter along said distal portion of said inner catheter;

a self-expanding stent compressed onto said inner catheter and said restraint member, said self-expanding stent comprising elastic wire with a plurality of bends at a proximal end and a distal end of said stent, said wire being woven between said proximal and distal ends, wherein each of said protrusions extends through an opening formed by one of said bends at said proximal end of said stent, said hub thereby being disposed under said proximal end of said stent and no other protrusions on said restraint member extending through an opening of said stent, a middle portion of said stent being disposed on said outer diameter of said inner catheter, wherein said outer diameter of said inner catheter is smaller than said outer surface of said hub of said restraint member;

an outer sheath disposed over said inner catheter, said restraint member, and said stent; and

wherein said restraint member comprises a row of partial protrusions around the circumference of said hub offset from said row of protrusions so that the partial protrusions do not extend through any openings in said self-expanding stent.

2. The medical device according to claim 1, wherein said protrusions are oblong-shaped.

3. The medical device according to claim 2, wherein said protrusions fill about 80% to about 90% of the open area of each of said openings, said open areas being defined by said bends and adjacent struts of said stent when said stent is compressed.

4. The medical device according to claim 1, wherein said protrusions are tapered from said base to said outer end about 10°

to about 20°

.

5. The medical device according to claim 1, wherein said protrusions are cone-shaped.

6. The medical device according to claim 1, wherein said protrusions are pyramid-shaped.

7. The medical device according to claim 1, wherein said restraint member is made from a polymer.

8. The medical device according to claim 1, further comprising a stop surface disposed proximally adjacent said hub of said restraint member, said stop surface extending outward from said outer surface of said hub.

9. The medical device according to claim 1, further comprising a second restraint member disposed at said distal end of said stent, wherein each of said protrusions of said second restraint member extends through an opening formed by one of said bends at said distal end of said stent, said hub of said second restraint member thereby being disposed under said distal end of said stent and no other protrusions on said second restraint member extending through an opening of said stent.

10. The medical device according to claim 1, wherein an open space is disposed between said bends of said proximal end and said distal end of said stent and said stent and said outer diameter of said inner catheter, no portion of said outer diameter of said inner catheter extending outward from said outer surface of said restraint member between said bends of said proximal end and said distal end of said stent.

11. The medical device according to claim 1, wherein an open space is disposed between said bends of said proximal end and said distal end of said stent and said stent and said outer diameter of said inner catheter, no portion of said outer diameter of said inner catheter extending outward from said inner diameter of said restraint member between said bends of said proximal end and said distal end of said stent.

12. The medical device according to claim 1, wherein said restraint member is made from a polymer, further comprising a stop surface disposed proximally adjacent said hub of said restraint member, said stop surface extending outward from said outer surface of said hub, and wherein an open space is disposed between said bends of said proximal end and said distal end of said stent and said stent and said outer diameter of said inner catheter, no portion of said outer diameter of said inner catheter extending outward from said outer surface of said restraint member between said bends of said proximal end and said distal end of said stent.

13. The medical device according to claim 12, wherein no portion of said outer diameter of said inner catheter extends outward from said inner diameter of said restraint member between said bends of said proximal end and said distal end of said stent.

14. The medical device according to claim 13, further comprising a second restraint member disposed at said distal end of said stent, wherein each of said protrusions of said second restraint member extends through an opening formed by one of said bends at said distal end of said stent, said hub of said second restraint member thereby being disposed under said distal end of said stent and no other protrusions on said second restraint member extending through an opening of said stent.

15. The medical device according to claim 13, wherein said protrusions are oblong-shaped, said protrusions fill about 80% to about 90% of the open area of each of said openings, said open areas being defined by said bends and adjacent struts of said stent when said stent is compressed, and said protrusions are tapered from said base to said outer end about 10°

to about 20°

.

16. The medical device according to claim 1, further comprising a stop surface disposed proximally adjacent said hub of said restraint member, said stop surface extending outward from said outer surface of said hub, and wherein an open space is disposed between said bends of said proximal end and said distal end of said stent and said stent and said outer diameter of said inner catheter, no portion of said outer diameter of said inner catheter extending outward from said inner diameter of said restraint member between said bends of said proximal end and said distal end of said stent.

17. The medical device according to claim 16, wherein said protrusions are oblong-shaped.

18. The medical device according to claim 17, wherein said protrusions fill about 80% to about 90% of the open area of each of said openings, said open areas being defined by said bends and adjacent struts of said stent when said stent is compressed, and said protrusions are tapered from said base to said outer end about 10°

to about 20°

.

21. The medical device according to claim 6, wherein said protrusions are separated by a criss-crossing helix pattern on the outer surface of said hub.

22. The medical device according to claim 6, wherein said protrusions are four-sided pyramid-shaped.

19. A method of manufacturing a medical device, comprising:

providing an inner catheter comprising an outer diameter along a distal portion of said inner catheter;

providing a tube comprising an inner diameter;

forming a plurality of protrusions on said tube, wherein after forming said protrusions said tube comprises an outer surface with said protrusions extending outward therefrom and a thickness between said inner diameter and said outer surface;

sliding said inner diameter of said tube over a distal end and said outer diameter of said inner catheter;

bonding said inner diameter of said tube to said inner catheter;

compressing a self-expanding stent onto said inner catheter and said tube, wherein said stent comprises elastic wire with a plurality of bends at a proximal end and a distal end of said stent, said wire being woven between said proximal and distal ends, wherein each of said protrusions extends through an opening formed by one of said bends at said proximal end of said stent, said tube thereby being disposed under said proximal end of said stent and no other protrusions on said tube extending through an opening of said stent, a middle portion of said stent being disposed on said outer diameter of said inner catheter, wherein said outer diameter of said inner catheter is smaller than said outer surface of said tube;

sliding an outer sheath over said compressed stent, said inner catheter and said tube; and

wherein said tube comprises a row of partial protrusions around the circumference of the outer surface of the tube offset from said protrusions so that the partial protrusions do not extend through any openings in said self-expanding stent.

20. The method according to claim 19, further comprising:

bonding a distal tip onto said distal end of said inner catheter after sliding said tube over said distal end and before said stent is compressed onto said inner catheter;

sliding an inner diameter of another of said tube over said distal end and said outer diameter of said inner catheter;

bonding said inner diameter of said another of said tube to said inner catheter;

wherein each of said protrusions of said another of said tube extends through an opening formed by one of said bends at said distal end of said stent, said another of said tube thereby being disposed under said distal end of said stent and no other protrusions on said another of said tube extending through an opening of said stent

said forming said plurality of protrusions on said tube comprises removing material from said tube; and

said forming said plurality of protrusions on said tube comprises removing material along a length of a longer tube and then slicing a length from said longer tube.