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 8,663,301 B2
• Filed: 01/22/2010
• Issued: 03/04/2014
• Est. Priority Date: 12/11/2007
• Status: Active Grant

• Current Assignee: Cornell University
• Original Assignee: Cornell University
• Inventors: Riina, Howard, Andrews, Robert, Strohl, Clair, Milsom, Jeffrey, Cornhill, J. Frederick, Smith, Kevin Thomas, Lamphere, David G., Nguyen, Tuan Anh
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): SHIPLEY, AMY R
• Application Number:
  US12/657,598
• Publication Number:
  US 20100268260A1
• Time in Patent Office: 1,502 Days
• Field of Search: 606/200, 606/191, 606127-128, 623 111- 122, 623/23.72
• US Class Current: 623/1.11
• 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 17/12113 within an aneurysm
• 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 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00871 polymeric
• 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 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• 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

Abstract

An expandable substantially spherical structure for deployment in a blood vessel or other body lumen, comprising:

• • an open frame formed out of a closed loop of filament and configured to assume (i) a collapsed configuration in the form of a substantially two-dimensional elongated loop structure so as to facilitate insertion into the blood vessel or other body lumen, and (ii) an expanded configuration in the form of a three-dimensional substantially spherical structure so as to facilitate retention at a site in the blood vessel or other body lumen; and
  • a flow-restricting face carried by the open frame;
  • wherein the open frame is configured so as to permit substantially normal flow therethrough when the open frame is in its expanded configuration, and further wherein the flow-restricting face is configured so as to restrict flow therethrough.

Claims

1. A device for positioning within a lumen of a blood vessel, adjacent to the mouth of an aneurysm extending from the blood vessel, for causing thrombosis of the aneurysm while maintaining substantially normal blood flow through the lumen of the blood vessel, the device consisting of:

a single closed loop of elastic filament configurable between;

(i) an elongated, substantially linear configuration formed by two parallel lengths of the closed loop of elastic filament, whereby to facilitate movement along the lumen of the blood vessel; and

(ii) a spheroidal configuration for lodging within the lumen of the blood vessel, the spheroidal configuration providing (a) a single flow-restricting face sized and configured so as to cover the mouth of the aneurysm and restrict blood flow to the aneurysm, the size of the single flow-restricting face being larger than the mouth of the aneurysm so that the single flow-restricting face seats against the mouth of the aneurysm so as to restrict blood flow to the aneurysm while permitting substantially normal blood flow through the blood vessel when the flow-restricting face is positioned over the mouth of the aneurysm, with the degree of restriction at the mouth of the aneurysm being such that the aneurysm thromboses when the single flow-restricting face is positioned over the mouth of the aneurysm, the single, flow-restricting face comprising a plurality of lengths of the closed loop of elastic filament disposed in close proximity to one another, and (b) an open frame for engaging the interior side wall of the blood vessel and holding the single flow-restricting face against the mouth of the aneurysm, the open frame configured so as to maintain substantially normal blood flow through the lumen of the blood vessel, wherein the single flow-restricting face has a higher density of wire than the open frame.

2. A device according to claim 1 wherein the single flow-restricting face is not impervious to fluid flow.

3. A device according to claim 1 wherein the dimensions of the spheroidal configuration are established by the size of the blood vessel.

4. A device according to claim 1 wherein the single closed loop of elastic filament is configured to assume its spheroidal configuration in situ within the blood vessel.

5. A device according to claim 1 wherein the single closed loop of elastic filament comprises a resilient material.

6. A device according to claim 5 wherein the resilient material comprises a shape memory alloy.

7. A device according to claim 5 wherein the resilient material comprises a polymer.

8. A device according to claim 1 wherein the single closed loop of elastic filament is configured to assume its elongated, substantially linear configuration when cooled to a temperature below body temperature and to assume its spheroidal configuration when heated to body temperature.

9. A device according to claim 1 wherein the single closed loop of elastic filament is configured to transform from its spheroidal configuration to its elongated, substantially linear configuration by the application of mechanical stress.

10. A device according to claim 1 wherein the single closed loop of elastic filament is configured to transform from its elongated, substantially linear configuration to its spheroidal configuration by the release of mechanical stress.

11. A device according to claim 1 further comprising

an installation tool for carrying the single closed loop of elastic filament to a deployment site, wherein the installation tool comprises:

an elongated structure having a first mount for seating a first portion of the single closed loop of elastic filament and a second mount for seating a second portion of the single closed loop of elastic filament, the first mount and the second mount being movable relative to one another between a first position and a second position so that (i) when the first portion of the single closed loop of elastic filament is seated in the first mount and the second portion of the single closed loop of elastic filament is seated in the second mount and the first mount and the second mount are in their first position, the single closed loop of elastic filament is in its spheroidal configuration, and (ii) when the first portion of the single closed loop of elastic filament is seated in the first mount and the second portion of the single closed loop of elastic filament is seated in the second mount and the first mount and second mount are in their second position, the single closed loop of elastic filament is in its elongated, substantially linear configuration.

12. A device according to claim 11 wherein the elongated structure comprises a hollow catheter.

13. A device according to claim 11 wherein the first mount of the installation tool is formed by a slot in the distal end of the elongated structure.

14. A device according to claim 11 wherein the second mount of the installation tool is formed by a projection extending laterally from the elongated structure.

15. A device according to claim 11 wherein the first mount is fixed in position on the elongated structure and the second mount is movable relative to the elongated structure.

16. A device according to claim 11 further comprising a hollow sleeve sized to receive the single closed loop of elastic filament when the single closed loop of elastic filament is mounted on the elongated structure.

17. A device according to claim 1 wherein the plurality of lengths of the closed loop of elastic filament are disposed in a patterned configuration.

18. A device according to claim 1 wherein the plurality of lengths of the closed loop of elastic filament are disposed in a non-overlapping configuration.

19. A device according to claim 1 wherein the plurality of lengths of the closed loop of elastic filament are disposed in an ordered configuration.

20. A device according to claim 1 wherein the plurality of lengths of the closed loop of elastic filament are disposed in a nestled configuration.

21. A device according to claim 1 wherein the plurality of lengths of the closed loop of elastic filament are disposed in a pre-determined configuration.

22. A device according to claim 1 wherein the plurality of lengths of the closed loop of elastic filament are disposed in a switchback configuration.

23. A method for causing thrombosis of an aneurysm extending from a blood vessel while maintaining substantially normal blood flow through the lumen of the blood vessel, the method comprising:

providing a device consisting of;

a single closed loop of elastic filament configurable between;

(i) an elongated, substantially linear configuration formed by two parallel lengths of the closed loop of elastic filament, whereby to facilitate movement along the lumen of the blood vessel; and

(ii) a spheroidal configuration for lodging within the lumen of the blood vessel, the spheroidal configuration providing (a) a single flow-restricting face sized and configured so as to cover the mouth of the aneurysm and restrict blood flow to the aneurysm, the size of the single flow-restricting face being larger than the mouth of the aneurysm so that the single flow-restricting face seats against the mouth of the aneurysm so as to restrict blood flow to the aneurysm while permitting substantially normal blood flow through the blood vessel when the single flow-restricting face is positioned over the mouth of the aneurysm, with the degree of restriction at the mouth of the aneurysm being such that the aneurysm thromboses when the single flow-restricting face is positioned over the mouth of the aneurysm, the single flow-restricting face comprising a plurality of lengths of the closed loop of elastic filament disposed in close proximity to one another, and (b) an open frame for engaging the interior side wall of the blood vessel and holding the single flow-restricting face against the mouth of the aneurysm, the open frame configured so as to maintain substantially normal blood flow through the lumen of the blood vessel, wherein the single flow-restricting face has a higher density of wire than the open frame;

delivering the single closed loop of elastic filament to the aneurysm site while the single closed loop of elastic filament is configured in its elongated configuration; and

transforming the single closed loop of elastic filament to its spheroidal configuration so that the single closed loop of elastic filament is lodged against the mouth of the aneurysm, with the single flow-restricting face being positioned over the mouth of the aneurysm so as to restrict blood flow to the aneurysm while permitting substantially normal blood flow through the blood vessel and with the open frame maintaining substantially normal blood flow through the lumen of the blood vessel.

24. A method according to claim 23 wherein the aneurysm comprises a lateral aneurysm.

25. A method according to claim 23 wherein the aneurysm comprises a bifurcation aneurysm.

26. A method according to claim 23 wherein the dimensions of the spheroidal configuration are established by the size of the blood vessel.

27. A method according to claim 23 wherein the single closed loop of elastic filament is configured to assume its spheroidal configuration in situ within the blood vessel.

28. A method according to claim 23 wherein the single closed loop of elastic filament is configured to transform from its spheroidal configuration to its elongated, substantially linear configuration by the application of mechanical stress.

29. A method according to claim 23 wherein the single closed loop of elastic filament is configured to transform from its elongated, substantially linear configuration to its spheroidal configuration by the release of mechanical stress.

30. A method according to claim 23 wherein the plurality of lengths of the closed loop of elastic filament are disposed in a patterned configuration.

31. A method according to claim 23 wherein the plurality of lengths of the closed loop of elastic filament are disposed in a non-overlapping configuration.

32. A method according to claim 23 wherein the plurality of lengths of the closed loop of elastic filament are disposed in an ordered configuration.

33. A method according to claim 23 wherein the plurality of lengths of the closed loop of elastic filament are disposed in a nestled configuration.

34. A method according to claim 23 wherein the plurality of lengths of the closed loop of elastic filament are disposed in a pre-determined configuration.

35. A method according to claim 23 wherein the plurality of lengths of the closed loop of wire are disposed in a switchback configuration.

36. A method according to claim 23 wherein the single flow-restricting face is not impervious to fluid flow.

37. A method according to claim 23 wherein the single closed loop of elastic filament comprises a resilient material.

38. A method according to claim 37 wherein the resilient material comprises a shape memory alloy.

39. A method according to claim 37 wherein the resilient material comprises a polymer.

40. A method according to claim 23 wherein the single closed loop of elastic filament is configured to assume its elongated, substantially linear configuration when cooled to a temperature below body temperature and to assume its spheroidal configuration when heated to body temperature.

41. A method according to claim 23 further comprising an installation tool for carrying the single closed loop of elastic filament to a deployment site, wherein the installation tool comprises:

an elongated structure having a first mount for seating a first portion of the single closed loop of elastic filament and a second mount for seating a second portion of the single closed loop of elastic filament, the first mount and the second mount being movable relative to one another between a first position and a second position so that (i) when the first portion of the single closed loop of elastic filament is seated in the first mount and the second portion of the single closed loop of elastic filament is seated in the second mount and the first mount and the second mount are in their first position, the single closed loop of elastic filament is in its spheroidal configuration, and (ii) when the first portion of the single closed loop of elastic filament is seated in the first mount and the second portion of the single closed loop of elastic filament is seated in the second mount and the first mount and second mount are in their second position, the single closed loop of elastic filament is in its elongated, substantially linear configuration.

42. A method according to claim 41 wherein the elongated structure comprises a hollow catheter.

43. A method according to claim 41 wherein the first mount of the installation tool is formed by a slot in the distal end of the elongated structure.

44. A method according to claim 41 wherein the second mount of the installation tool is formed by a projection extending laterally from the elongated structure.

45. A method according to claim 41 wherein the first mount is fixed in position on the elongated structure and the second mount is movable relative to the elongated structure.

46. A method according to claim 41 further comprising a hollow sleeve sized to receive the single closed loop of elastic filament when the single closed loop of elastic filament is mounted on the elongated structure.