Method and apparatus for restricting flow through an opening in the side wall

• US 8,968,382 B2
• Filed: 10/09/2012
• Issued: 03/03/2015
• 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, Smith, Kevin Thomas, Nguyen, Tuan Anh, Dillon, Christopher, Gupta, Rainuka, Van Hill, Jeremy, Johnston, Leslie, Schneider, Darren, Greeley, Gabriel, DeNardo, Matthew, Sathe, Rahul
• Primary Examiner(s): Dowe, Katherine
• Assistant Examiner(s): Shipley, Amy
• Application Number:
  US13/648,177
• Publication Number:
  US 20130103074A1
• Time in Patent Office: 875 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 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

A device comprising a single closed loop of elastic filament configurable between (i) a first configuration for movement along a blood vessel; and (ii) a second configuration for lodging within a blood vessel, the second configuration providing a single flow-restricting face sized and configured to cover the mouth of the aneurysm and obstruct blood flow to the aneurysm while permitting substantially normal blood flow through the blood vessel, with the degree of obstruction at the mouth of the aneurysm being such that the aneurysm thromboses when the face is positioned over the aneurysm, the flow-restricting face comprising a plurality of lengths of the closed loop of filament disposed in close proximity to one another in a switchback configuration, and at least one leg for holding the flow-restricting face adjacent the mouth of the aneurysm, the leg configured so as to maintain substantially normal blood flow through the blood vessel.

Claims

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

a single closed loop of elastic filament configurable between;

(i) a first longitudinally-expanded, radially and laterally-contracted configuration for movement along a blood vessel, the first configuration providing two parallel lengths of the closed loop of elastic filament; and

(ii) a second longitudinally-contracted, radially and laterally-expanded spherical configuration for lodging within a blood vessel, the second configuration providing (a) a single flow-restricting face sized and configured so as to cover the mouth of the aneurysm and obstruct 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 obstruction at the mouth of the aneurysm being such that the aneurysm thromboses when the 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 in a switchback configuration, and (b) at least one leg for holding the single flow-restricting face adjacent the mouth of the aneurysm, the at least one leg configured so as to maintain substantially normal blood flow through the blood vessel.

2. A device according to claim 1 wherein the flow restricting face comprises a plurality of parallel lengths of elastic filament, with adjacent parallel lengths of elastic filament being connected by end returns.

3. A device according to claim 2 wherein the flow-restricting face is formed by two symmetric halves separated by a midline, and further wherein the internal end returns of each half of the flow-restricting face about the midline, and the external end returns of each half of the flow-restricting face define the perimeter of the flow-restricting face.

4. A device according to claim 3 wherein the internal end returns of one half of the flow-restricting face are aligned with the internal end returns of the other half of the flow-restricting face.

5. A device according to claim 3 wherein the internal end returns of one half of the flow-restricting face are offset from the internal end returns of the other half of the flow-restricting face.

6. A device according to claim 2 wherein the flow-restricting face is formed by two halves each extending over a midline, and further wherein the internal end returns of each half of the flow-restricting face are disposed across the midline, and the external end returns of each half of the flow-restricting face define the perimeter of the flow-restricting face.

7. A device according to claim 6 wherein the internal end returns of one half of the flow-restricting face are aligned with the internal end returns of the other half of the flow-restricting face, and with the adjacent parallel lengths of elastic filament, form a plurality of enclosures.

8. A device according to claim 7 wherein the plurality of enclosures are aligned along the midline.

9. A device according to claim 7 wherein the plurality of enclosures are offset from the midline in an alternating pattern.

10. A device according to claim 6 wherein the internal end returns of one half of the flow-restricting face are offset from the internal end returns of the other half of the flow-restricting face.

11. A device according to claim 1 wherein the single, flow-restricting face follows the curve of a generally spherical structure.

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

providing a device comprising;

a single closed loop of elastic filament configurable between;

(i) a first longitudinally-expanded, radially and laterally-contracted configuration for movement along a blood vessel, the first configuration providing two parallel lengths of the closed loop of elastic filament; and

(ii) a second longitudinally-contracted, radially and laterally-expanded spherical configuration for lodging within a blood vessel, the second configuration providing (a) a single flow-restricting face sized and configured so as to cover the mouth of the aneurysm and obstruct 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 obstruction at the mouth of the aneurysm being such that the aneurysm thromboses when the 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 in a switchback configuration, and (b) at least one leg for holding the single flow-restricting face adjacent the mouth of the aneurysm, the at least one leg configured so as to maintain substantially normal blood flow through the blood vessel;

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

transforming the single closed loop of elastic filament to its second configuration so that the single closed loop of elastic filament is lodged adjacent the mouth of the aneurysm, with the single flow-restricting face being positioned over the mouth of the aneurysm so as to obstruct blood flow to the aneurysm while permitting substantially normal blood flow through the blood vessel and with the at least one leg maintaining substantially normal blood flow through the blood vessel.

13. A method according to claim 12 wherein the flow restricting face comprises a plurality of parallel lengths of elastic filament, with adjacent parallel lengths of elastic filament being connected by end returns.

14. A method according to claim 13 wherein the flow-restricting face is formed by two symmetric halves separated by a midline, and further wherein the internal end returns of each half of the flow-restricting face abut the midline, and the external end returns of each half of the flow-restricting face define the perimeter of the flow-restricting face.

15. A method according to claim 14 wherein the internal end returns of one half of the flow-restricting face are aligned with the internal end returns of the other half of the flow-restricting face.

16. A method according to claim 14 wherein the internal end returns of one half of the flow-restricting face are offset from the internal end returns of the other half of the flow-restricting face.

17. A method according to claim 13 wherein the flow-restricting face is formed by two halves each extending over a midline, and further wherein the internal end returns of each half of the flow-restricting face are disposed across the midline, and the external end returns of each half of the flow-restricting face define the perimeter of the flow-restricting face.

18. A method according to claim 17 wherein the internal end returns of one half of the flow-restricting face are aligned with the internal end returns of the other half of the flow-restricting face, and with the adjacent parallel lengths of elastic filament, form a plurality of enclosures.

19. A method according to claim 18 wherein the plurality of enclosures are aligned along the midline.

20. A method according to claim 18 wherein the plurality of enclosures are offset from the midline in an alternating pattern.

21. A method according to claim 17 wherein the internal end returns of one half of the flow-restricting face are offset from the internal end returns of the other half of the flow-restricting face.

22. A method according to claim 12 wherein the single, flow-restricting face follows the curve of a generally spherical structure.

23. A system for treating a patient, comprising:

a device for positioning within the lumen of a blood vessel, adjacent to the mouth of an aneurysm extending from the lumen of the blood vessel, for causing thrombosis of the aneurysm while maintaining substantially normal blood flow through the blood vessel, the device comprising;

a single closed loop of elastic filament configurable between;

(i) a first longitudinally-expanded, radially and laterally-contracted configuration for movement along a blood vessel, the first configuration providing two parallel lengths of the closed loop of elastic filament; and

(ii) a second longitudinally-contracted, radially and laterally-expanded spherical configuration for lodging within a blood vessel, the second configuration providing (a) a single flow-restricting face sized and configured so as to cover the mouth of the aneurysm and obstruct 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 obstruction at the mouth of the aneurysm being such that the aneurysm thromboses when the 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 in a switchback configuration, and (b) at least one leg for holding the single flow-restricting face adjacent the mouth of the aneurysm, the at least one leg configured so as to maintain substantially normal blood flow through the blood vessel; and

an inserter for carrying the device 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 second 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 first configuration.

24. Apparatus according to claim 23 wherein the inserter comprises a first member carrying the first mount and a second member carrying the second mount, and further wherein the first member is movable relative to the second member.

25. Apparatus according to claim 24 wherein the first member and the second member are arranged in coaxial, telescoping relation.

26. Apparatus according to claim 24 wherein the second member further comprises a third mount for seating a third portion of the closed loop.

27. Apparatus according to claim 24 wherein the first member and the second member are independently slidably mounted to a third member.

28. Apparatus according to claim 24 wherein the first mount is formed out of an atraumatic material.