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 8,728,141 B2
• Filed: 12/11/2008
• Issued: 05/20/2014
• 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. Fredrick, Smith, Kevin Thomas, Lamphere, David G., Nguyen, Tuan Anh
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): SHIPLEY, AMY R
• Application Number:
  US12/332,727
• Publication Number:
  US 20090264914A1
• Time in Patent Office: 1,986 Days
• Field of Search: 606/200, 606/191, 606127-128, 623 111- 122
• 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 17/12172 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. 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 elastic filament configurable between;

(i) an elongated, substantially linear configuration, 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 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 elastic filament to the aneurysm site while the single elastic filament is configured in its elongated configuration; and

transforming the single elastic filament to its spheroidal configuration so that the single 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.

2. A method according to claim 1 wherein the aneurysm comprises a lateral aneurysm.

3. A method according to claim 1 wherein the aneurysm comprises a bifurcation aneurysm.

4. A method according to claim 1 wherein the dimensions of the spheroidal configuration of the single elastic filament are established by the size of the blood vessel.

5. A method according to claim 1 wherein the single elastic filament is configured to assume its spheroidal configuration in situ within the blood vessel.

6. A method according to claim 1 wherein the plurality of lengths of the elastic filament are disposed in a patterned configuration.

7. A method according to claim 1 wherein the plurality of lengths of the elastic filament are disposed in a non-overlapping configuration.

8. A method according to claim 1 wherein the plurality of lengths of the elastic filament are disposed in an ordered configuration.

9. A method according to claim 1 wherein the plurality of lengths of the elastic filament are disposed in a nestled configuration.

10. A method according to claim 1 wherein the plurality of lengths of the elastic filament are disposed in a pre-determined configuration.

11. A method according to claim 1 wherein the plurality of lengths of the elastic filament are disposed in a switchback configuration.

12. A method according to claim 1 wherein the single elastic filament comprises a resilient material.

13. A method according to claim 12 wherein the resilient material comprises a shape memory alloy.

14. A method according to claim 12 wherein the resilient material comprises a polymer.

15. A method according to claim 1 wherein the single 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.

16. A method according to claim 1 wherein the single elastic filament is configured to transform from its elongated, substantially linear configuration to its spheroidal configuration using temperature modulation applied by resistance heating.

17. A method according to claim 1 wherein the single elastic filament is configured to transform from its elongated, substantially linear configuration to its spheroidal configuration using temperature modulation applied by passing fluid of an appropriate temperature through the single elastic filament.

18. A method according to claim 1 wherein the single elastic filament is configured to transform from its elongated, substantially linear configuration to its spheroidal configuration using an internal balloon.

19. A method according to claim 1 wherein the single elastic filament is formed out of a non-absorbable material.

20. A method according to claim 1 wherein the single elastic filament is configured so as to be flexible.

21. A method according to claim 1 wherein the method further comprises providing an installation tool for carrying the single elastic filament 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 an extended position;

wherein the lumen is sized so as to receive the single elastic filament when the single elastic filament is in its elongated, substantially linear configuration, and further wherein the pusher is configured to eject the single elastic filament from the lumen when the pusher is moved from its retracted position to its extended position.

22. A method according to claim 21 wherein the installation tool further comprises a mechanism for supplying heat to the single elastic filament, whereby to facilitate transforming the single elastic filament from its elongated, substantially linear configuration to its spheroidal configuration.