Method and apparatus for restricting flow through an opening in the side wall of a body lumen, and/or for reinforcing a weakness in the side wall of a body lumen, while still maintaining substantially normal flow through the body lumen

• US 8,956,475 B2
• Filed: 04/02/2012
• Issued: 02/17/2015
• Est. Priority Date: 12/11/2007
• Status: Active Grant

• Current Assignee: Cornell University
• Original Assignee: Cornell University
• Inventors: Riina, Howard, Milsom, Jeffrey, Cornhill, J. Frederick, Nguyen, Tuan Anh, Keough, Kevin, Andrews, Robert, Smith, Kevin
• Primary Examiner(s): WYSZOMIERSKI, GEORGE P
• Application Number:
  US13/437,777
• Publication Number:
  US 20120289988A1
• Time in Patent Office: 1,051 Days
• Field of Search: None
• US Class Current: 148/563
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/30242 spherical
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2230/0095 Saddle-shaped
• CPC Class Codes: A61H 23/00 Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms apparatus for passive exercising A61H1/00; generating or transmitting mechanical vibrations in general B06B
• CPC Class Codes: A61N 5/0616 Skin treatment other than tanning
• CPC Class Codes: C22F 1/006 Resulting in heat recoverable alloys with a memory effect

Abstract

A method for making a device for causing thrombosis of an aneurysm, wherein said device comprises a single elastic filament configurable between (i) an elongated, substantially linear configuration, and (ii) a longitudinally-contracted, substantially three-dimensional configuration, said method comprising:

• • providing a sheet of shape memory material;
  • producing a single filament, two-dimensional interim structure from said sheet of shape memory material;
  • mounting said single filament, two-dimensional interim structure to a fixture so that said single filament, two-dimensional interim structure is transformed into said longitudinally-contracted, substantially three-dimensional configuration; and
  • heat treating said single filament, two-dimensional interim structure while it is mounted to said fixture so as to produce said device in its longitudinally-contracted, substantially three-dimensional configuration.

Claims

1. A method for making a device for causing thrombosis of an aneurysm, wherein said device comprises a single elastic filament configurable between (i) an elongated, substantially linear configuration, and (ii) a longitudinally-contracted, substantially three-dimensional configuration, said method comprising:

providing a sheet of shape memory material;

producing a single filament, two-dimensional interim structure from said sheet of shape memory material, wherein said single filament, two-dimensional interim structure is temporarily held to said sheet of shape memory material by an attachment tab;

mounting said single filament, two-dimensional interim structure to a fixture so that said single filament, two-dimensional interim structure is transformed into said longitudinally-contracted, substantially three-dimensional configuration; and

heat treating said single filament, two-dimensional interim structure while it is mounted to said fixture so as to produce said single elastic filament in its longitudinally-contracted, substantially three-dimensional configuration.

2. A method according to claim 1 wherein said single filament, two-dimensional interim structure is produced from said sheet of shape memory material by etching.

3. A method according to claim 1 wherein said single filament, two-dimensional interim structure is produced from said sheet of shape memory material by laser cutting.

4. A method according to claim 1 further comprising the step of electro-polishing said single filament, two-dimensional interim structure before it is mounted to said fixture.

5. A method according to claim 4 wherein said step of electro-polishing said single filament, two-dimensional interim structure is performed while said single filament, two-dimensional interim structure is still attached to said sheet of shape memory material.

6. A method according to claim 1 wherein said fixture comprises a three-dimensional body.

7. A method according to claim 6 wherein said three-dimensional body comprises surface features for releasably retaining said single filament, two-dimensional interim structure on said three-dimensional body.

8. A method according to claim 7 wherein said surface features comprise posts mounted to said three-dimensional body.

9. A method according to claim 1 wherein said fixture comprises a two part fixture comprising a male half and a female half.

10. A method according to claim 9 wherein said male half of said fixture comprises surface features for releasably retaining said single filament, two-dimensional interim structure on said male half of said fixture.

11. A method according to claim 9 wherein said surface features comprise posts mounted to said male half of said fixture.

12. A method according to claim 1 wherein said step of heat treating comprises heating followed by quenching.

13. A method according to claim 1 wherein said single filament, two-dimensional interim structure comprises a continuous closed loop.

14. A method according to claim 1 wherein said single filament, two-dimensional interim structure comprises two distinct ends.

15. A method according to claim 14 comprising the additional step of unifying the two distinct ends so as to form a continuous closed loop.

16. A method according to claim 15 wherein the two distinct ends are unified by welding.

17. A method according to claim 15 wherein the two distinct ends are unified by banding.

18. A method according to claim 1 wherein a plurality of single filament, two-dimensional interim structures are produced from said sheet of shape memory material.

19. A method according to claim 1 wherein said single filament, two-dimensional interim structure is released from said sheet of shape memory material by severing said attachment tab.

20. A method according to claim 1 wherein said single filament, two-dimensional interim structure has a width which varies along its length.

21. A method according to claim 1 wherein said single filament, two-dimensional interim structure has a thickness which varies along its length.

22. A method according to claim 1 wherein said single filament, two-dimensional interim structure has a cross-section which varies along its length.

23. A method according to claim 1 wherein said single filament, two-dimensional interim structure comprises a cross-section comprising flat edges.

24. A method according to claim 1 wherein said single filament, two-dimensional interim structure comprises a cross-section comprising flat edges and rounded edges.

25. A method according to claim 1 wherein said single filament, two-dimensional interim structure comprises a cross-section which is circular.

26. A method according to claim 1 wherein said single filament, two-dimensional interim structure comprises a cross-section which is ovoid.

27. A method according to claim 1 wherein said sheet of shape memory material has different material properties in different dimensions.

28. A method according to claim 1 wherein the shape memory material is selected from the group consisting of:

a nickel titanium alloy, a copper-based alloy, an iron-based alloy, and a shape memory polymer.

29. A method according to claim 28 wherein the nickel titanium alloy comprises nitinol.

30. A method for making a device for causing thrombosis of an aneurysm, wherein said device comprises a single elastic filament configurable between (i) an elongated, substantially linear configuration, and (ii) a longitudinally-contracted, substantially three-dimensional configuration, said method comprising:

providing a filament of shape memory material, wherein said filament is produced from a sheet of shape memory material, and further wherein said filament is temporarily held to the sheet of shape memory material by an attachment tab;

mounting said filament of shape memory material to a fixture so that said filament is transformed into said longitudinally-contracted, substantially three-dimensional configuration; and

heat treating said filament so as to produce said single elastic filament in its longitudinally-contracted, substantially three-dimensional configuration.

31. A method according to claim 30 wherein said fixture comprises a three-dimensional body having surface features for releasably retaining said filament of shape memory material on said three-dimensional body, and further wherein mounting said filament of shape memory material to said fixture comprises winding said filament of shape memory material around said surface features.

32. A method according to claim 31 wherein said surface features comprise posts mounted to said three-dimensional body.