Aneurysm neck bridging processes with revascularization systems methods and products thereby

• US 8,926,680 B2
• Filed: 06/10/2008
• Issued: 01/06/2015
• Est. Priority Date: 11/12/2007
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Ferrera, David A., Fulkerson, John
• Primary Examiner(s): SHI, KATHERINE MENGLIN
• Application Number:
  US12/136,737
• Publication Number:
  US 20090125053A1
• Time in Patent Office: 2,401 Days
• Field of Search: 623/1.11, 623/1.12, 606/108, 606/157, 606/191, 606/192, 606/194, 606/198, 606/200
• 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 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2250/0059 temporary

Abstract

Devices, methods and systems facilitate and enable vessel wall treatment, particularly at the neck of an aneurysm. A tethered cage-like structure functions in conjunction with supplemental therapies such as a vaso-occlusive coil delivering microcatheter system and/or pharmaceutical delivery, among other things, by stabilizing vessel walls and providing tethered cage-like therapeutic support for treating aneurysms, temporarily or on an implantable basis.

Claims

1. An improved system for bridging aneurysms in neurovasculature, the system comprising:

a first microcatheter for accessing neurovascular vessels over a guidewire;

a variable stiffness delivery tube comprising a proximal section and a distal section,

wherein said distal section has a decreased stiffness and a greater flexibility as compared to the proximal section to allow tracking through tortuous anatomy of the neurovasculature,

wherein said variable stiffness delivery tube comprises an internal lumen configured to receive a guidewire, said guidewire providing trackability, maintained access and vessel support; and

a tethered cage-like structure eccentrically coupled to said delivery tube via a plurality of tethers such that the tethered cage-like structure is temporary and configured for removal from a patient'"'"'s body,

wherein said cage-like structure has an open proximal end, an open distal end, and a tapering portion, the tapering portion located between the plurality of tethers and the open distal end, the tapering portion tapering, in absence of external forces, between a proximal end of the tapering portion and the open distal end such that said cage-like structure has a first circumference at the proximal end of the tapering portion and a second circumference, smaller than the first circumference, at the open distal end,

wherein said cage-like structure comprises a plurality of struts and a plurality of openings formed between the struts to provide vessel support without obstructing blood flow,

wherein said cage-like structure can be delivered to a target site local to an aneurysm and positioned to bridge the neck of the aneurysm, thereby covering the aneurysm to reconstruct a vessel wall; and

whereby a second microcatheter can be threaded through one or more open cells of the cage-like structure for delivery of supplemental therapy to the aneurysm while maintaining revascularization.

2. The system of claim 1, the supplemental therapy being deployment of vasa-occlusive coils.

3. The system of claim 1, wherein the aneurysm is reperfused through the origin of the aneurysm.

4. The system of claim 1, wherein the tethered cage-like structure is expandable and reconstrainable.

5. The system of claim 1, wherein the tethered cage-like structure is self-expandable.

6. The system of claim 1, wherein the aneurysm comprises a wide-neck aneurysm having a dome to neck ratio of less than 2:

1.

7. The system of claim 1, wherein said delivery tube comprises a hypotube.

8. The system of claim 1, wherein said cage-like structure comprises a super-elastic material.

9. The system of claim 8, wherein said cage-like structure comprises Nitinol.

10. The system of claim 1, wherein said cage-like structure is coupled to the delivery tube by soldering.

11. The system of claim 1, wherein said cage-like structure is coupled to the delivery tube by welding.

12. The system of claim 1, wherein said cage-like structure is coupled to the delivery tube by press-fitting.

13. The system of claim 1, wherein said cage-like structure has an aspect ratio of 0.05 (thickness/width) or less.

14. The system of claim 1, wherein said cage-like structure is configured to be recaptured into the first microcatheter and repositioned.

15. The system of claim 1, wherein the aneurysm comprises a wide-neck aneurysm having a neck greater than 4 mm.

16. A temporary aneurysm neck bridge device for placement across a neck of an aneurysm, the temporary aneurysm neck bridge device comprising:

a delivery device;

a tethered cage-like structure eccentrically coupled to a distal end of the delivery device by a plurality of tether lines such that the tethered cage-like structure is configured for removal from a patient'"'"'s body, the tethered cage-like structure having an open strut design that is expandable from a non-expanded configuration to an expanded configuration upon being unsheathed from a microcatheter, said tethered cage-like structure having an open proximal end, an open distal end, and a tapering portion, the tapering portion located between the plurality of tether lines and the open distal end, the tapering portion tapering, in absence of external forces, between a proximal end of the tapering portion and the open distal end such that said tethered cage-like structure has a first circumference at the proximal end of the tapering portion and a second circumference, smaller than the first circumference, at the open distal end of the tapering portion, said tethered cage-like structure being configured to be delivered within a blood vessel to a neck of an aneurysm while housed within the microcatheter in the non-expanded configuration; and

radiopaque markers configured to allow tracking of the cage-like structure,

wherein, in use, said tethered cage-like structure is configured to transition from said non-expanded configuration to said expanded configuration at a location such that the tethered cage-like structure bridges the neck of the aneurysm upon retraction of the microcatheter within which the tethered cage-like structure is housed.

17. The device of claim 16, the tethered cage-like structure further comprised of variable cell sizes.

18. The device of claim 16, the radiopaque markers further comprised of at least one of platinum and gold pegs pressed into pre-laser cut holes.

19. The device of claim 16, wherein the delivery device is a delivery tube.

20. The device of claim 19, wherein the delivery tube is a variable stiffness tube that is configured to navigate through tortuous anatomy of the cerebral vasculature to distal cerebral arteries.

21. The device of claim 20, wherein a distal portion of the delivery tube has greater flexibility than a proximal portion of the delivery tube.

22. The device of claim 16, wherein the delivery device is a delivery wire.