ANEURYSM OCCLUSION SYSTEM AND METHOD

• US 20140180377A1
• Filed: 12/20/2012
• Published: 06/26/2014
• Est. Priority Date: 12/20/2012
• Status: Abandoned Application

• Current Assignee: Penumbra, Inc.
• Original Assignee: Penumbra, Inc.
• Inventors: Bose, Arani, Gupta, Vikas
• Application Number:
  US13/722,709
• Publication Number:
  US 20140180377A1
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526

Abstract

An aneurysm occlusion system includes devices positionable within a cerebral blood vessel covering a neck of an aneurysm in the blood vessel. A component device includes an expandable tubular body, an expandable anchor, and a link connecting the body to the anchor. One or more devices deployed using a method according to the invention includes a novel feature that guarantees that the distal high coverage segment aligns with the neck of the aneurysm. A single device or multiple devices, used in conjunction with an embolic material or coil, may be combined to form a system according to the invention. When positioned and deployed strategically either alone or with a second device utilizing a method according to the invention, the system has a high coverage region covering a neck of an aneurysm, and a gap between the system and healthy vessel. The system and method prevent blood flow into an aneurysm while permitting blood flow through healthy vessel.

Claims

1. A system for use in treatment of an aneurysm having a neck, the aneurysm located near a bifurcation in a vessel, the system comprising:

at least one elongate delivery device; and

at least one intravascular device comprising a reduced profile delivery configuration and an expanded profile deployment configuration, a proximal end and a distal end, a generally tubular segment having a longitudinal gap, the generally tubular segment disposed near the distal end and positionable across the neck of the aneurysm;

an anchor disposed near the proximal end and positionable within the vessel; and

a flexible link joining the generally tubular segment and the anchor, the flexible link positionable within or across a bifurcation in a vessel.

2. The system according to claim 1 wherein said longitudinal gap extends the length of the generally tubular segment.

3. The system according to claim 2 wherein said longitudinal gap has a first width at the proximal end of the generally tubular segment and a second width at the distal end of the generally tubular segment, wherein said first width is greater than said second width.

4. The system according to claim 1 wherein said generally tubular segment comprises at least one longitudinal standard and a plurality of struts extending a length from said longitudinal standard to define a generally tubular wall, wherein said struts terminate to define the longitudinal gap in the wall.

5. The system according to claim 1 wherein said generally tubular segment comprises a first longitudinal standard and a second longitudinal standard and struts extending from the first longitudinal standard to the second longitudinal standard, wherein said longitudinal gap is defined by the open space between the first longitudinal standard and the second longitudinal standard.

6. The system according to claim 5 wherein said struts are generally V-shaped.

7. The system according to claim 6 wherein said V-shaped struts have an apex and further comprise S-shaped members disposed near the apex.

8. The system according to claim 1 wherein said anchor comprises a first and a second lateral apex for engaging the wall of the vessel.

9. The system according to claim 5 wherein said first and second longitudinal standards extend proximally from said generally tubular element to said define said flexible link, and wherein said first longitudinal standard further splits to form a first and a second tine, and each tine extends proximally;

and said second longitudinal standard further splits to form a first and a second tine, and each tine extends proximally, each tine of the first longitudinal standard then converging with each tine of said second longitudinal standard to define lateral apexes of the anchor.

10. The system according to claim 1 wherein said system further comprises an embolic device or material positionable through said gap and into the aneurysm.

11. A system for use in treatment of an aneurysm having a neck, the aneurysm located near a bifurcation in a vessel, the system comprising:

at least one elongate delivery device; and

a first intravascular device and a second intravascular device, at least one of the first and second intravascular devices comprising a reduced profile delivery configuration and an expanded profile deployment configuration, a proximal end and a distal end, a generally tubular segment disposed near the distal end and positionable across the neck of the aneurysm, an anchor disposed near the proximal end and positionable within the vessel, and at least one flexible link joining the generally tubular segment and the anchor, the flexible link positionable within or across a bifurcation in a vessel;

wherein said generally tubular segment comprises a longitudinal gap.

12. The system according to claim 11 wherein said longitudinal gap extends the length of the generally tubular segment.

13. The system according to claim 12 wherein said longitudinal gap has a first width at the proximal end of the generally tubular segment and a second width at the distal end of the generally tubular segment, wherein said first width is greater than said second width.

14. The system according to claim 11 wherein said generally tubular segment comprises at least one longitudinal standard and a plurality of struts extending a length from said longitudinal standard to define a generally tubular wall, wherein said struts terminate to define the longitudinal gap in the wall.

15. The system according to claim 11 wherein said generally tubular segment comprises a first longitudinal standard and a second longitudinal standard and struts extending from the first longitudinal standard to the second longitudinal standard, wherein said longitudinal gap is defined by the open space between the first longitudinal standard and the second longitudinal standard.

16. The system according to claim 15 wherein said struts are generally V-shaped.

17. The system according to claim 16 wherein said V-shaped struts have an apex and further comprise S-shaped members disposed near the apex.

18. The system according to claim 11 wherein said anchor comprises a first and a second lateral apex for engaging the wall of the vessel.

19. The system according to claim 15 wherein said first and second longitudinal standards extend proximally from said generally tubular element to said define said flexible link, and wherein said first longitudinal standard further splits to form a first and a second tine, and each tine extends proximally;

and said second longitudinal standard further splits to form a first and a second tine, and each tine extends proximally, each tine of the first longitudinal standard then converging with each tine of said second longitudinal standard to define lateral apexes of the anchor.

20. The system according to claim 11 wherein said system further comprises an embolic device or material positionable through said gap and into the aneurysm.

21. The system according to claim 15 wherein both the first and the second intravascular devices comprise struts and said system further comprises an area of overlap of said struts.

22. The system according to claim 21 wherein said area of overlap is positionable across the neck of the aneurysm.

23. A method of manufacture of an intravascular device, said method comprising the steps of:

providing a tube comprising one or more shape memory materials;

cutting the tube according to a predetermined pattern to impart a generally tubular segment having a plurality of struts and a longitudinal gap between the struts;

an anchor and a link between the generally tubular segment and the anchor;

shaping the intravascular device to impart a desired orientation of the generally tubular segment to the anchor;

applying a shape memory set to the shaped cut tube.

24. The method according to claim 23 wherein said shape memory material is nitinol.

25. The method according to claim 23 wherein said predetermined pattern defines at least two elongate standards.

26. The method according to claim 25 wherein said predetermined pattern defines the plurality of struts having at least one end connected to an elongate standard.

27. The method according to claim 23 wherein said struts are V-shaped.

28. A method of treating an aneurysm located in a blood vessel of a subject, the aneurysm having a neck and the method comprising the steps of:

introducing into the blood vessel a first intravascular device that is radially expandable from a compressed position to an expanded position, the intravascular device comprising a tubular element having a longitudinal gap;

an anchor; and

a link between the tubular element and the anchor;

bridging at least some of the neck of the aneurysm with the tubular element;

deploying the anchor within the vessel; and

delivering one or more embolic materials to the aneurysm.

29. The method according to claim 28 wherein the step of bridging the neck of the aneurysm includes introducing the tubular element distally of the aneurysm;

partially deploying the intravascular device so that the tubular element is expanded;

then retracting the intravascular device proximally to permit the tubular element to align its struts along the neck of the aneurysm and to align the longitudinal gap opposite the aneurysm; and

then fully deploying the intravascular device to permit the anchor to engage the vessel wall.

30. The method according to claim 28 with the additional step of deploying a second intravascular device prior to the step of delivering an embolic material, by introducing and deploying the second intravascular device through the anchor of the first intravascular device.

31. The method according to claim 30 wherein each tubular element has a plurality of struts and said second intravascular device is deployed so that the struts of each tubular element overlap to form a high coverage region across at least some of the aneurysm neck.

32. The method according to claim 31 wherein the step of deploying said second intravascular device further comprises introducing said second intravascular device into the vessel distally of the aneurysm;

partially deploying said second intravascular device so that the tubular element is expanded;

retracting the intravascular device proximally to permit the struts to self align with the neck of the aneurysm and the longitudinal gap to self align opposite the aneurysm neck;

deploying the entire intravascular device to permit the anchor to engage the vessel wall.