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 20100268260A1
• Filed: 01/22/2010
• Published: 10/21/2010
• Est. Priority Date: 12/11/2007
• Status: Active Grant

• Current Assignee: Cornell University
• Original Assignee: Cornell University
• Inventors: Smith, Kevin Thomas, Andrews, Robert, Nguyen, Tuan Anh, Milsom, Jeffrey, Cornhill, J. Frederick, Riina, Howard, Strohl, Clair, Lamphere, David G.
• Granted Patent: US 8,663,301 B2
• Time in Patent Office: Days
• US Class Current: 606/191
• 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. 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.

2. An expandable substantially spherical structure according to claim 1 wherein the flow-restricting face is impervious to fluid flow.

3. An expandable substantially spherical structure according to claim 1 wherein the flow-restricting face is not impervious to fluid flow.

4. An expandable substantially spherical structure according to claim 3 wherein the flow-restricting face is formed out of the same closed loop of filament as the open frame.

5. An expandable substantially spherical structure according to claim 1 wherein the open frame is self-sizing, with the dimensions of the expanded configuration of the open frame being established by the size of the blood vessel or other body lumen.

6. An expandable substantially spherical structure according to claim 1 wherein the open frame is configured to assume its expanded configuration in situ within the blood vessel or other body lumen.

7. An expandable substantially spherical structure according to claim 1 wherein the open frame comprises a resilient material.

8. An expandable substantially spherical structure according to claim 7 wherein the resilient material comprises a shape memory alloy.

9. An expandable substantially spherical structure according to claim 7 wherein the resilient material comprises a polymer.

10. An expandable substantially spherical structure according to claim 1 wherein the open frame is configured to assume its collapsed configuration when cooled to a temperature below body temperature and to assume its expanded configuration when heated to body temperature.

11. An expandable substantially spherical structure according to claim 1 wherein the open frame is configured to transform from its expanded configuration to its collapsed configuration by the application of mechanical stress.

12. An expandable substantially spherical structure according to claim 1 wherein the open frame is configured to transform from its collapsed configuration to its expanded configuration by the release of mechanical stress.

13. A system for restricting flow to an opening in the side wall of a blood vessel or other body lumen and/or reinforcing a weakness in the side wall or apex of a bifurcation of the blood vessel or other body lumen, while maintaining substantially normal flow through the blood vessel or other body lumen, comprising:

an expandable substantially spherical structure for deployment in the 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 expandable open frame is in its expanded configuration, and further wherein the flow-restricting face is configured so as to restrict flow therethrough; and

an installation tool for carrying the expandable substantially spherical structure to a deployment site, wherein the installation tool comprises;

an elongated structure having a first mount for seating a first portion of the closed loop and a second mount for seating a second portion of the closed loop, 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 closed loop is seated in the first mount and the second portion of the closed loop is seated in the second mount and the first mount and second mount are in their first position, the open frame is in its expanded substantially spherical configuration, and (ii) when the first portion of the closed loop is seated in the first mount and the second portion of the closed loop is seated in the second mount and the first mount and second mount are in their second position, the open frame is in its collapsed and elongated configuration.

14. A system according to claim 13 wherein the elongated structure comprises a hollow catheter.

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

16. A system according to claim 13 wherein the second mount of the installation tool is formed by a projection extending laterally outboard from the elongated structure.

17. A system according to claim 13 wherein the first mount is fixed in position on the elongated structure and the second mount is movable relative to the elongate structure.

18. A system according to claim 13 further comprising a hollow sleeve sized to receive the expandable substantially spherical structure when the expandable substantially spherical structure is mounted on the elongated structure.

19. A method for restricting flow to an opening in the side wall of a body lumen while maintaining substantially normal flow through the body lumen, comprising:

providing an expandable substantially spherical structure for deployment in the 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 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;

delivering the expandable substantially spherical structure to a therapy site within the body lumen while the open frame is in its collapsed configuration; and

transforming the expandable substantially spherical structure from its collapsed configuration to its expanded configuration so that the expandable substantially spherical structure is securely lodged in the body lumen, with the flow-restricting face of the expandable substantially spherical structure positioned so as to restrict flow to the opening in the side wall of the body lumen and with the open frame permitting flow through the body lumen.

20. A method according to claim 19 wherein the body lumen comprises a blood vessel.

21. A method according to claim 20 wherein the opening of the side wall of the blood vessel comprises the opening to an aneurysm.

22. A method according to claim 21 wherein the aneurysm comprises a lateral aneurysm.

23. A method according to claim 21 wherein the aneurysm comprises a bifurcation aneurysm.

24. A method according to claim 19 wherein the open frame is self-sizing, with the dimensions of the expanded configuration of the open frame being established by the size of the blood vessel or other body lumen.

25. A method according to claim 19 wherein the open frame is configured to assume its expanded configuration in situ within the blood vessel or other body lumen.

26. A method according to claim 19 wherein the flow-restricting face of the expandable substantially spherical structure is formed out of the same closed loop of filament as the open frame of the expandable substantially spherical structure.

27. A method according to claim 19 wherein the open frame is configured to transform from its expanded configuration to its collapsed configuration by the application of mechanical stress.

28. A method according to claim 19 wherein the open frame is configured to transform from its collapsed configuration to its expanded configuration by the release of mechanical stress.

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

an open frame configured to assume a collapsed configuration and an expanded configuration;

a flow-restricting face carried by the open frame; and

a plurality of stabilizing legs attached to, and extending away from, the open frame;

wherein the open frame and the plurality of stabilizing legs are 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.

30. An expandable substantially spherical structure according to claim 29 wherein the open frame and the plurality of stabilizing legs are self-sizing, with the dimensions of the expanded configuration of the open frame and the dimensions of the plurality of stabilizing legs being established by the size of the blood vessel or other body lumen.

31. An expandable substantially spherical structure according to claim 29 wherein the open frame is configured to assume its expanded configuration in situ within the blood vessel or other body lumen.

32. An expandable substantially spherical structure according to claim 29 wherein the open frame and the plurality of stabilizing legs comprise a resilient material.

33. An expandable substantially spherical structure according to claim 32 wherein the resilient material comprises a shape memory alloy.

34. An expandable substantially spherical structure according to claim 32 wherein the resilient material comprises a polymer.

35. An expandable substantially spherical structure according to claim 29 wherein the plurality of stabilizing legs form a conical structure about a common axis.

36. An expandable substantially spherical structure according to claim 29 wherein the open frame comprises a plurality of struts, and further wherein the plurality of stabilizing legs form extensions of the plurality of struts.

37. An expandable substantially spherical structure according to claim 29 wherein the open frame comprises a plurality of axially aligned struts.

38. An expandable substantially spherical structure according to claim 37 wherein the axially aligned struts are configured so as to bow outwardly from a longitudinal axis of the expandable substantially spherical structure when the open frame is in its expanded configuration.

39. An expandable substantially spherical structure according to claim 37 wherein the axially aligned struts are configured so as to extend parallel to one another, whereby to form the skeleton of a cylindrical structure when the open frame is in its collapsed configuration.

40. An expandable substantially spherical structure according to claim 37 wherein the plurality of axially aligned struts define a longitudinal axis, and further wherein the flow-restricting face intersects the longitudinal axis.

41. An expandable substantially spherical structure according to claim 37 wherein the plurality of axially aligned struts define a longitudinal axis, and further wherein the flow-restricting face is laterally displaced from the longitudinal axis.

42. An expandable substantially spherical structure according to claim 29 wherein the open frame comprises an annular ring at an outer surface of the open frame.

43. An expandable substantially spherical structure according to claim 42 wherein the annular ring terminates one end of the open frame.

44. An expandable substantially spherical structure according to claim 29 wherein the flow-restricting face comprises a substantially complete surface.

45. An expandable substantially spherical structure according to claim 29 wherein the flow-restricting face comprises a face having a high strut density.

46. A method for restricting flow through an opening in the side wall of a body lumen while maintaining substantially normal flow through the body lumen, comprising:

providing an expandable substantially spherical structure for deployment in the body lumen, comprising;

an open frame configured to assume a collapsed configuration and an expanded configuration;

a flow-restricting face carried by the open frame; and

a plurality of stabilizing legs attached to, and extending away from, the open frame;

wherein the open frame and the plurality of stabilizing legs are configured so as to permit 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;

delivering the expandable substantially spherical structure to a therapy site within the body lumen while the open frame is in its collapsed configuration and the plurality of stabilizing legs are in a collapsed configuration; and

transforming the expandable substantially spherical structure from its collapsed configuration to its expanded configuration, and transforming the plurality of stabilizing legs from their collapsed configuration to an expanded configuration, so that the expandable substantially spherical structure is securely lodged in the body lumen, with the flow-restricting face of the expandable substantially spherical structure positioned so as to restrict flow to the opening in the side wall of the body lumen and with the open frame and the plurality of stabilizing legs permitting flow through the body lumen.

47. A method according to claim 46 wherein the body lumen comprises a blood vessel.

48. A method according to claim 47 wherein the opening of the side wall of the blood vessel comprises the opening to an aneurysm.

49. A method according to claim 48 wherein the aneurysm comprises a lateral aneurysm.

50. A method according to claim 48 wherein the aneurysm comprises a bifurcation aneurysm.

51. A method according to claim 47 wherein the open frame is self-sizing, with the dimensions of the expanded configuration of the open frame and the plurality of stabilizing legs being established by the size of the blood vessel or other body lumen.

52. A method according to claim 47 wherein the open frame is configured to assume its expanded configuration in situ within the blood vessel or other body lumen.

53. A method according to claim 46 wherein the expandable substantially spherical structure is delivered to the therapy site with the open frame preceeding the stabilizing legs.

54. A method according to claim 46 wherein the expandable substantially spherical structure is delivered to the therapy site with the stabilizing legs preceeding the open frame.