Removable occlusion system for aneurysm neck

• US 5,928,260 A
• Filed: 07/10/1997
• Issued: 07/27/1999
• Est. Priority Date: 07/10/1997
• Status: Expired due to Term

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Dassa, Alyssa, Guterman, Lee R., Chin, Yem, Hudson, Richard, Tremaglio, Anthony R. Jr., McCrory, Jennifer J.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US08/891,011
• Time in Patent Office: 747 Days
• Field of Search: 606/200, 606/194, 606/159, 623/1, 604/104-108
• US Class Current: 606/200
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• 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 17/12036 partial occlusion
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

A system for treating an aneurysm in a vessel includes a delivery device having a delivery portion suitable for delivery of embolic material. The delivery device is placed in a neck of the aneurysm and an expandable member is placed proximate the neck. The expandable member is expanded to overlie substantially the entire neck. Embolic material is delivered to the aneurysm with a delivery device. The expandable member is held over the neck to inhibit movement of the embolic material out of the aneurysm. Blood is allowed to flow out of the aneurysm, past the neck of the aneurysm, and through the vessel while the expandable member is held over the neck of the aneurysm.

Claims

1. A system for treating an aneurysm in a vessel, the aneurysm having a neck communicating with the vessel, the system comprising:

an embolic material; and

a delivery catheter adapted for delivering the embolic material to the aneurysm, the delivery catheter comprising;

a first elongate member;

a second elongate member longitudinally movable relative to the first elongate member;

a tubular expandable member radially expandable and contractible in response to longitudinal movement of the first and second elongate members relative to one another; and

wherein the expandable member is configured, when overlying the neck of the aneurysm, to allow delivery of embolic material to the aneurysm, to inhibit the embolic material from moving out of the aneurysm into the vessel, and to allow blood to flow through the vessel and to flow out of the aneurysm during delivery of the embolic material into the aneurysm.

2. The system of claim 1 wherein the first and second elongate members are arranged coaxially with one another.

3. The system of claim 2 wherein the expandable member comprises:

a first collapsible tube generally coaxially arranged with the first and second elongate members, having a first end connected to the first elongate member and a second end connected to the second elongate member and being configured such that longitudinal movement of the first and second elongate members relative to one another causes variation in a distance between the first and second ends of the first collapsible tube.

4. The system of claim 3 wherein the first collapsible tube comprises:

a first plurality of struts having distal ends coupled to one of the first and second elongate members and proximal ends coupled to another of the first and second elongate members, the first struts being configured such that movement of the proximal and distal ends thereof toward one another causes the first struts to bow radially outwardly relative to the first and second elongate members.

5. The system of claim 4 wherein the first and second elongate members are rotatable relative to one another and configured such that an outer diameter defined by the first struts, when bowed outwardly, is adjustable based on rotation of the first and second elongate members relative to one another.

6. The system of claim 4 wherein the first struts are configured such that the distal ends of the first struts are angularly offset from the proximal ends of the first struts about an outer periphery of the first and second elongate members.

7. The system of claim 4 wherein the expandable member comprises:

a second collapsible tube generally coaxially arranged with the first collapsible tube having a first end operably connected to the first elongate member and a second end operably connected to the second elongate member and being configured such that longitudinal movement of the first and second elongate members relative to one another causes variation in a distance between the first and second ends of the second collapsible tube.

8. The system of claim 7 wherein the second collapsible tube comprises:

a second plurality of struts having distal ends coupled to one of the first and second elongate members and proximal ends coupled to another of the first and second elongate members, the second struts being configured such that movement of the proximal and distal ends thereof toward one another causes the second struts to bow radially outwardly relative to the first and second elongate members.

9. The system of claim 8 wherein the second struts are angularly offset from the first struts about the periphery of the first and second elongate members.

10. The system of claim 4 and further comprising:

a thread-like member connected to the first struts and configured to reside in spaces between the first struts when the first struts are expanded.

11. The system of claim 4 wherein the first struts have distal regions with a larger surface area than proximal regions thereof.

12. The system of claim 11 wherein the proximal regions of the first struts are perforated.

13. The system of claim 4 and further comprising:

a perforated covering disposed about the first struts and configured to be carried radially outwardly with the first struts.

14. The system of claim 1 wherein the expandable member comprises:

an expandable mesh disposed about an outer periphery of the first and second elongate members.

15. The system of claim 14 wherein the mesh has at least one aperture therein sized to receive a delivery device therethrough for delivering embolic material.

16. The system of claim 1 wherein the expandable member comprises:

a self expanding device biased to be retained in a collapsed position in response to the first and second elongate members being maintained in a first longitudinal position relative to one another.

17. The system of claim 16 wherein the self-expanding device comprises:

a plurality of biased members biased to an expanded position relative to the elongate members and configured such that when the elongate members are in the first position relative to one another, the biased members are held in a radially contracted position closely approximating an outer diameter of at least one of the first and second elongate members and when the elongate members are in a second position relative to one another, the second position being longitudinally offset from the first position, the biased members are allowed to expand radially outwardly.

18. The system of claim 17 wherein the first elongate member includes a hub with a retaining rim, and wherein the second elongate member includes the biased members, the retaining rim and the biased members having cooperable surfaces such that when the first and second elongate members are in the first position, the retaining rim engages the biased members retaining them in a collapsed position, and when the first and second elongate members are in the second position, the cooperable surfaces are out of engagement with one another allowing the biased members to deploy to a radially expanded position.

19. The system of claim 1 and further comprising:

a third elongate member cooperable with the first and second elongate members and having a delivery portion proximate a distal end thereof and configured to deliver embolic material to the aneurysm.

20. The system of claim 1 wherein one of the first and second elongate members includes a delivery portion for delivering the embolic material to the aneurysm.

21. A method of treating an aneurysm having a neck communicating with a vessel, comprising:

providing a delivery device having a delivery portion suitable for delivery of embolic material;

placing the delivery device in the neck of the aneurysm;

placing a removable expandable member proximate the neck;

expanding the expandable member to overlie substantially the entire neck;

delivering embolic material to the aneurysm with the delivery device; and

holding the expandable member over the neck to inhibit movement of the embolic material out of the aneurysm, while allowing flow of blood through the vessel past the neck of the aneurysm.

22. The method of claim 21 wherein holding the expandable member over the neck comprises:

allowing blood to flow out of the aneurysm during delivery of the embolic material to the aneurysm.

23. The method of claim 22 wherein the expandable member is provided on a first elongate member and wherein holding the expandable member over the neck comprises:

pushing longitudinally on the first elongate member such that the expandable member engages a wall of the vessel about the neck of the aneurysm.

24. The method of claim 21 wherein placing an expandable member proximate the neck comprises:

providing a first elongate member and a second elongate member longitudinally movable relative to the first elongate member, wherein the expandable member is operably coupled to a distal region of the first and second elongate members; and

wherein expanding the expandable member includes longitudinally moving the first and second elongate members relative to one another such that the expandable member moves between an expanded position and a contracted position.

25. The method of claim 24 wherein placing an expandable member proximate the neck comprises:

providing a first collapsible tube generally coaxially arranged with the first and second elongate members, having a first end connected to the first elongate member and a second end connected to the second elongate member; and

wherein expanding the expandable member includes longitudinally moving the first and second elongate members relative to one another to cause variation in a distance between the first and second ends of the first collapsible tube.

26. The method of claim 25 wherein providing a first collapsible tube comprises:

providing a first plurality of struts having distal ends coupled to one of the first and second elongate members and proximal ends coupled to another of the first and second elongate members; and

wherein expanding the expandable member includes manipulating the first and second elongate members relative to one another to cause movement of the proximal and distal ends of the first plurality of struts toward one another causing the first struts to bow radially outwardly relative to the first and second elongate members.

27. The method of claim 26 wherein the first and second elongate members are rotatable relative to one another and wherein expanding the expandable member comprises:

rotating the first and second elongate members relative to one another to adjust an outer diameter defined by the first struts, when bowed outwardly.

28. The method of claim 26 wherein placing the expandable member proximate the neck comprises:

providing a second collapsible tube generally coaxially arranged with the first collapsible tube having a first end operably connected to the first elongate member and a second end operably connected to the second elongate member; and

wherein expanding the expandable member includes longitudinally moving the first and second elongate members relative to one another to cause variation in a distance between the first and second ends of the second collapsible tube.

29. The method of claim 28 wherein providing a second collapsible tube comprises:

providing a second plurality of struts having distal ends coupled to one of the first and second elongate members and proximal ends coupled to another of the first and second elongate members; and

wherein expanding the expandable member includes moving the proximal and distal ends thereof toward one another to cause the second struts to bow radially outwardly relative to the first and second elongate members.

30. The method of claim 29 wherein the second struts are angularly offset from the first struts about the periphery of the first and second elongate members and wherein expanding the expandable member includes causing the first and second struts to bow outwardly such that radially outwardly displaced portions of the second struts reside in spaces between radially outwardly displaced portions of the first struts.

31. The method of claim 21 wherein a first portion of the expandable member, when expanded, has apertures therein such that the first portion has a first surface area per unit of area, and wherein a second portion of the expandable member, when expanded, has apertures therein such that the second portion has a second surface area per unit of area, the second surface area being smaller than the first surface area, and wherein holding the expandable member over the neck comprises:

holding the first portion of the expandable member over the neck while retaining the second portion in the parent vessel.

32. The method of claim 24 wherein the expandable member comprises an expandable mesh disposed about an outer periphery of the first and second elongate members and wherein expanding the expandable member comprises:

manipulating the first and second elongate members to move the expandable mesh to the expanded position.

33. The method of claim 32 wherein the mesh has at least one aperture therein sized to receive a delivery device therethrough for delivering embolic material;

and wherein delivering embolic material comprises;

delivering the embolic material with the delivery device through the at least one aperture.

34. The method of claim 33 wherein delivering the embolic material with the delivery device comprises:

delivering the embolic material through a delivery portion in one of the first and second elongate members.

35. The method of claim 24 wherein placing an expandable member proximate the neck comprises:

providing a first elongate member and a second elongate member longitudinally movable relative to the first elongate member, wherein the expandable member is operably coupled to a distal region of at least one of the first and second elongate members; and

providing a self expanding device biased to be retained in a collapsed position in response to the first and second elongate members being maintained in a first longitudinal position relative to one another; and

wherein expanding the expandable member comprises moving the first and second elongate members out of the first longitudinal position.

36. The method of claim 35 wherein providing the self-expanding device comprises:

providing a plurality of biased members biased to an expanded position relative to the elongate members and configured such that when the elongate members are in the first position relative to one another, the biased members are held in a radially contracted position closely approximating an outer diameter of at least one of the first and second elongate members; and

wherein expanding the expandable member comprises moving the elongate members to a second position relative to one another, the second position being longitudinally offset from the first position, such that the biased members are allowed to expand radially outwardly.

37. The method of claim 36 wherein the first elongate member includes a hub with a retaining rim, and wherein the second elongate member includes the biased members, the retaining rim and the biased members having cooperable surfaces such that when the first and second elongate members are in the first position, the retaining rim engages the biased members retaining them in a collapsed position;

and

wherein expanding the expandable member includes moving the first and second elongate members to the second position such that the cooperable surfaces are out of engagement with one another allowing the biased members to deploy to a radially expanded position.

38. The method of claim 21 wherein the delivery device comprises a third elongate member cooperable with the first and second elongate members and wherein delivering embolic material to the aneurysm comprises moving a delivery portion of the third elongate member into the aneurysm and delivering the embolic material to the aneurysm with the third elongate member.

39. The method of claim 21 and further comprising:

allowing the embolic material to remain in the aneurysm for a time period while holding the expandable member over the neck; and

removing the expandable member from the vessel.