Systems and methods for aneurysm treatment and vessel occlusion

• US 8,470,013 B2
• Filed: 10/20/2009
• Issued: 06/25/2013
• Est. Priority Date: 10/20/2008
• Status: Expired due to Fees

• Current Assignee: 2377469 Ontario Incorporated
• Original Assignee: IMDS Corporation, Neil Duggal
• Inventors: Duggal, Neil, De Hoog, Robert John, Lee, Donald H., Raymond, Louise C., Butters, Joshua A.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): DUKERT, BRIAN AINSLEY
• Application Number:
  US12/582,052
• Publication Number:
  US 20100106240A1
• Time in Patent Office: 1,344 Days
• Field of Search: 623/1.25
• US Class Current: 623/1.1
• 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 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61B 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• 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 2017/1205 Introduction devices
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• 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 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure

Abstract

A system for treating an aneurysm includes an expandable barrier positionable to bridge an aneurysm neck. The barrier may comprise a fiber mesh, a balloon or a molly anchor member, and may unroll, unfold, or inflate from a compact configuration to an expanded configuration. Expansion of the barrier may be greater radially than axially. A vaso-occlusive member comprising a coil or balloon may be deposited in the aneurysm. Another aneurysm treatment system comprises an outer fenestrated stent and/or an inner fenestrated sleeve, which may be implanted together adjacent an aneurysm neck to regulate blood flow to the aneurysm. The sleeve may be movable relative to the stent to open or occlude the fenestrations, which may vary in size, shape, and distribution. An intra-luminal vessel occlusion device comprises a stent and a sheath. A drawstring may be actuated to gradually close a sheath orifice to control blood flow through the vessel.

Claims

1. A system for treating an aneurysm in a parent vessel, the parent vessel defining a lumen and having a lumen wall, the aneurysm having a neck communicating with the lumen, the system comprising:

a flexible stent configured for placement in the parent vessel adjacent the aneurysm neck, the stent comprising a first end and a second end and a stent wall extending therebetween defining a stent bore, the stent wall permeable to blood flow, the stent wall comprising a plurality of stent cells;

an inner sleeve positioned inside and coaxial with the flexible stent, the inner sleeve comprising a first end and a second end and a sleeve wall extending therebetween defining a sleeve bore, the sleeve wall comprising a plurality of sleeve cells; and

an implantable barrier device configured for placement within the aneurysm neck, the barrier device positioned outside of the stent and adjacent to the stent, the barrier device formed as a disc-shaped member having a first side and a second side opposite the first side, the barrier device comprising a first compact configuration and a second expanded configuration, the barrier device impermeable to blood flow in the second expanded configuration, wherein in the second expanded configuration, the barrier device is shaped to extend across the aneurysm neck to prevent blood flow through the aneurysm neck;

a vaso-occlusive device positioned outside the stent and adjacent the barrier device, the barrier device between the vaso-occlusive device and the stent, wherein when the vaso-occlusive device is in the aneurysm and the barrier device is extended across the aneurysm neck in the second expanded configuration, the barrier device retains the vaso-occlusive device within the aneurysm

wherein the vaso-occlusive device comprises a balloon comprise-sing an elastomeric sheath having a plurality of zones, the zones having varying levels of elasticity.

2. The system of claim 1, wherein the barrier device is configured to radially expand from the first compact configuration to the second expanded configuration.

3. The system of claim 1, wherein the barrier device is configured to unroll or unfold from the first compact configuration to the second expanded configuration.

4. The system of claim 1, wherein the barrier device comprises a fiber mesh, the fiber mesh comprising strands chosen from the group consisting of:

nylon, polypropylene, polyester, polyurethane, polyvinyl chloride, Teflon, ePTFE, PTFE, polyethylene, polypropylene, silicone, PEEK, and hydrogel.

5. The system of claim 1, wherein the barrier device is connected to the vaso-occlusive device, and wherein the barrier device and the vaso-occlusive device are configured to be deliverable together through a microcatheter.

6. A system for treating an aneurysm in a parent vessel, the parent vessel defining a lumen and having a lumen wall, the aneurysm having a neck communicating with the lumen, the system comprising:

a flexible stent configured for placement in the parent vessel adjacent the aneurysm neck, the stent comprising a first end and a second end and a stent wall extending therebetween defining a stent bore, the stent wall permeable to blood flow, the stent wall comprising a plurality of stent cells, the stent further comprising a stent window located in the stent wall;

an inner sleeve positioned inside and coaxial with the flexible stent, the inner sleeve comprising a first end and a second end and a sleeve wall extending therebetween defining a sleeve bore, the sleeve wall comprising a plurality of sleeve cells; and

an implantable barrier device configured for placement within the aneurysm neck, the barrier device positioned outside of the stent and adjacent to the stent, the barrier device formed as a disc-shaped member having a first side and a second side opposite the first side, the barrier device comprising a first compact configuration and a second expanded configuration, the barrier device impermeable to blood flow in the second expanded configuration;

wherein in the second expanded configuration, the barrier device is shaped to extend across the aneurysm neck to prevent blood flow through the aneurysm neck.

7. The system of claim 6, wherein the sleeve further comprises a sleeve window located in the sleeve wall.

8. The system of claim 7, wherein the system comprises a closed configuration in which the sleeve window is offset from the stent window so that no portion of the sleeve window overlaps the stent window.

9. The system of claim 8, wherein the system further comprises an open configuration in which the sleeve window is aligned with the stent window, forming an unimpeded opening through the stent wall and the sleeve wall.

10. The system of claim 9, wherein the sleeve rotates relative to the stent to transform the system between the open configuration and the closed configuration.

11. A system for treating an aneurysm in a parent vessel, the parent vessel defining a lumen and having a lumen wall, the aneurysm having a neck communicating with the lumen, the system comprising:

a flexible stent configured for placement in the parent vessel adjacent the aneurysm neck, the stent comprising a first end and a second end and a stent wall extending therebetween defining a stent bore, the stent wall permeable to blood flow, the stent wall comprising a plurality of stent cells, a stent window located in the stent wall;

an inner sleeve positioned inside and coaxial with the flexible stent, the inner sleeve comprising a first end and a second end and a sleeve wall extending therebetween defining a sleeve bore, the sleeve wall comprising a plurality of sleeve cells, a sleeve window located in the sleeve wall;

wherein the system comprises an open configuration in which the sleeve window is aligned with the stent window, forming an unimpeded opening through the stent wall and the sleeve wall; and

wherein the system comprises a closed configuration in which the sleeve window is offset from the stent window so that no portion of the sleeve window overlaps the stent window.

12. The system of claim 11, wherein the vaso-occlusive device is a coil.

13. The system of claim 11, wherein the sleeve cells are differently shaped than the stent cells.

14. The system of claim 11, the system further comprising a vaso-occlusive device configured to be deployed inside the aneurysm, wherein the vaso-occlusive device is positioned outside the stent.

15. The system of claim 14, wherein the system is in the closed configuration, wherein the stent window is positioned between the sleeve wall and the vaso-occlusive device.

16. The system of claim 14, the system further comprising an expandable barrier configured for placement within the aneurysm neck, the expandable barrier comprising a first compact configuration and a second expanded configuration, the expandable barrier positioned between the stent and the vaso-occlusive device.

17. The system of claim 16, wherein the expandable barrier is positioned outside the sleeve wall, and the stent window is positioned between the sleeve wall and the expandable barrier.

18. The system of claim 16, wherein the vaso-occlusive device is coupled to the expandable barrier to be deployed with the expandable barrier.

19. The system of claim 16, wherein the expandable barrier comprises an anchor.

20. The system of claim 16, wherein the expandable barrier is disc-shaped, the expandable barrier comprising an outer side, an inner side and a stem.

21. The system of claim 20, wherein the outer side is coupled to the stem, and the stem is slidable relative to the inner side to transform the expandable barrier between the first compact configuration and the second expanded configuration.