METHOD AND APPARATUS FOR SEALING 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 MAINTAINING SUBSTANTIALLY NORMAL FLOW THROUGH THE BODY LUMEN

• US 20090264914A1
• Filed: 12/11/2008
• Published: 10/22/2009
• Est. Priority Date: 12/11/2007
• Status: Active Grant

• Current Assignee: Cornell University
• Original Assignee: Cornell University
• Inventors: Andrews, Robert, Nguyen, Tuan Anh, Milsom, Jeffrey, Riina, Howard, Strohl, Clair, Cornhill, J. Fredrick, Lamphere, David G., Smith, Kevin Thomas
• Granted Patent: US 8,728,141 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 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• 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 2017/12054 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

Abstract

An expandable 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; and
  • a closed 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 closed face is configured so as to obstruct flow therethrough.

Claims

1. An expandable 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; and

a closed 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 closed face is configured so as to obstruct flow therethrough.

2. An expandable 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.

3. An expandable 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.

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

5. An expandable spherical structure according to claim 4 wherein the resilient material comprises a shape memory alloy.

6. An expandable spherical structure according to claim 4 wherein the resilient material comprises a polymer.

7. An expandable 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.

8. An expandable spherical structure according to claim 1 wherein the open frame is configured to transform from its collapsed configuration to its expanded configuration using temperature modulation applied by resistance heating.

9. An expandable spherical structure according to claim 1 wherein the open frame is configured to transform from its collapsed configuration to its expanded configuration using temperature modulation applied by passing fluid of an appropriate temperature through the open frame.

10. An expandable spherical structure according to claim 1 wherein the open frame is configured to be expanded from its collapsed configuration to its expanded configuration using an internal balloon.

11. An expandable spherical structure according to claim 1 wherein the open frame comprises a plurality of struts.

12. An expandable spherical structure according to claim 11 wherein the plurality of struts form a plurality of interconnected polygons.

13. An expandable spherical structure according to claim 12 wherein the interconnected polygons comprise triangles.

14. An expandable spherical structure according to claim 12 wherein the interconnected polygons comprise rectangles.

15. An expandable spherical structure according to claim 12 wherein the interconnected polygons comprise hexagons.

16. An expandable spherical structure according to claim 12 wherein the interconnected polygons comprise irregular shapes.

17. An expandable spherical structure according to claim 11 wherein the open frame comprises a plurality of axially aligned struts.

18. An expandable spherical structure according to claim 17 wherein the axially aligned struts are configured so as to bow outwardly from a longitudinal axis of the expandable spherical structure when the open frame is in its expanded configuration.

19. An expandable spherical structure according to claim 18 herein 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.

20. An expandable spherical structure according to claim 17 wherein the plurality of axially aligned struts define a longitudinal axis, and further wherein the closed face intersects the longitudinal axis.

21. An expandable spherical structure according to claim 17 wherein the plurality of axially aligned struts define a longitudinal axis, and further wherein the closed face is laterally displaced from the longitudinal axis.

22. An expandable spherical structure according to claim 17 wherein the open frame comprises an annular ring at an outer surface of the open frame.

23. An expandable spherical structure according to claim 22 wherein the annular ring terminates one end of the open frame.

24. An expandable spherical structure according to claim 22 wherein the annular ring is diametrically opposed from the closed face.

25. An expandable spherical structure according to claim 22 wherein the annular ring is disposed at the equator of the open frame.

26. An expandable spherical structure according to claim 1 wherein the open frame comprises a spherical spiral structure.

27. An expandable spherical structure according to claim 1 wherein the open frame is formed out of an absorbable material.

28. An expandable spherical structure according to claim 1 wherein the open frame is formed out of a non-absorbable material.

29. An expandable spherical structure according to claim 1 wherein the open frame comprises a wire.

30. An expandable spherical structure according to claim 29 wherein the open frame comprises a single wire.

31. An expandable spherical structure according to claim 1 wherein the open frame and the closed face are formed out of a single wire.

32. An expandable spherical structure according to claim 1 wherein the closed face comprises a substantially complete surface.

33. An expandable spherical structure according to claim 1 wherein the closed face comprises a face having a high strut density.

34. An expandable spherical structure according to claim 1 wherein the closed face is configured so as to be substantially rigid.

35. An expandable spherical structure according to claim 1 wherein the closed face is configured so as to be flexible.

36. An expandable spherical structure according to claim 1 wherein the closed face is formed out of an absorbable material.

37. An expandable spherical structure according to claim 1 wherein the closed face is formed out of a non-absorbable material.

38. An expandable spherical structure according to claim 1 wherein the closed face comprises a wire.

39. An expandable spherical structure according to claim 38 wherein the closed face comprises a single wire.

40. A system for sealing 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 spherical structure for deployment in the blood vessel or other body lumen, comprising;

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

a closed 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 closed face is configured so as to obstruct flow therethrough; and

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

a hollow sleeve having a lumen therein; and

a pusher slidably movable within the lumen between a retracted position and a extended position;

wherein the lumen is sized so as to receive the expandable spherical structure when the open frame is in its collapsed configuration, and further wherein the pusher is configured to eject the expandable spherical structure from the lumen when the pusher is moved from its retracted position to its extended position.

41. A system according to claim 40 wherein the installation tool further comprises a gripper mechanism configured to releasably secure the expandable spherical structure to the hollow sleeve.

42. A system according to claim 40 wherein the installation tool further comprises an expandable balloon for transforming the open frame from its collapsed configuration to its expanded configuration.

43. A system according to claim 40 wherein the installation tool further comprises an expandable balloon which transports the structure to a therapy site and then transforms the open frame from its collapsed configuration to a expanded configuration.

44. A system according to claim 40 wherein the installation tool further comprises a mechanism for supplying heat to the expandable spherical structure, whereby to facilitate transforming the open frame from its collapsed configuration to its expanded configuration.

45. An endoluminal device for deployment in a blood vessel or other body lumen, comprising:

an expandable sphere-like structure which is collapsible for delivery to a therapy site within the body, wherein the expandable sphere-like structure comprises;

a first portion which has a high density face and is capable of obstructing fluid flow;

a second portion which is open and permits fluid flow therethrough; and

a third portion which facilitates control of the position, orientation and expansion of the expandable sphere-like structure.

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

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

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

a closed 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 closed face is configured so as to obstruct flow therethrough;

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

transforming the expandable spherical structure from its collapsed configuration to its expanded configuration so that the expandable spherical structure is securely lodged in the body lumen, with the closed face of the expandable spherical structure positioned so as to close off the opening in the side wall of the body lumen and with the open frame 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 46 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.

52. A method according to claim 46 wherein the open frame is configured to assume its expanded configuration in situ within the blood vessel or other body lumen.

53. A method for reinforcing a weakness in a side wall of a body lumen while maintaining flow through the body lumen, comprising:

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

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

a closed 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 closed face is configured so as to reinforce a weakness in a side wall of a body lumen;

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

transforming the expandable spherical structure from its collapsed configuration to its expanded configuration so that the expandable spherical structure is securely lodged in the body lumen, with the closed face of the expandable spherical structure positioned so as to reinforce the weakness in a side wall of the body lumen and with the open frame permitting flow through the body lumen.