Vascular device and method for valve leaflet apposition

• US 6,527,800 B1
• Filed: 06/08/2001
• Issued: 03/04/2003
• Est. Priority Date: 06/26/2000
• Status: Expired due to Term

• Current Assignee: REX Medical LP
• Original Assignee: REX Medical LP
• Inventors: McGuckin, James F. Jr., Briganti, Richard T.
• Primary Examiner(s): DeMille, Danton D.
• Assistant Examiner(s): Thanh, Quang D
• Application Number:
  US09/877,480
• Time in Patent Office: 634 Days
• Field of Search: 623/1.11, 623/1.23, 623/1.24, 623/1.19, 623/1.36, 623/1.14, 623/1.15, 623/2.36, 623/2.37, 623/902, 623/903, 128/898
• US Class Current: 623/1.24
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• 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 17/12109 in a blood vessel
• 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 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2475 Venous valves
• 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 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

A method for treating venous valve insufficiency comprising inserting a delivery device and a vascular device into a target vessel adjacent valve leaflets of the vessel, deploying the vascular device to an enlarged diameter to securely engage the internal wall of the vessel and reducing the diameter of the vascular device to move the vessel wall radially inwardly and bring the valve leaflets closer together.

Claims

1. A method for treating venous valve insufficiency comprising:

inserting a delivery device and a vascular device into a target vessel adjacent valve leaflets of the vessel;

deploying the vascular device to an enlarged diameter to securely engage the internal wall of the vessel; and

reducing the diameter of the vascular device to move the vessel wall radially inwardly and bring the valve leaflets closer together.

2. The method of claim 1, further comprising the step of deploying the vascular device to a first expanded diameter prior to deploying the device to the enlarged diameter, the first expanded diameter being less than the enlarged diameter.

3. The method of claim 2, wherein the step of reducing the diameter of the vascular device returns the device to a diameter substantially equal to the first expanded diameter.

4. The method of claim 3, wherein the step of deploying the vascular device to a first diameter comprises the step of exposing the vascular device from a sheath of the delivery device to enable the vascular device to return a shape memorized configuration in response to being warmed by body temperature.

5. The method of claim 4, wherein the step of the deploying the vascular device to an enlarged diameter includes the step of inflating a balloon positioned within the device.

6. The method of claim 1, wherein the step of the deploying the vascular device to an enlarged diameter includes the step of inflating a balloon positioned within the device.

7. The method of claim 6, wherein the step of inflating the balloon enables a plurality of vessel engaging members of the vascular device to penetrate and retain the vessel wall.

8. The method of claim 1, wherein the step of deploying the vascular device to an enlarged diameter moves a plurality of penetrating tips of vessel engaging members of the vascular device to a position substantially perpendicular to a longitudinal axis of the vascular device to engage the internal wall of the vessel.

9. The method of claim 1, wherein the delivery device is inserted to a position upstream of the valve leaflets to deliver the vascular device upstream of the valve leaflets.

10. The method of claim 1, wherein the delivery device is inserted to a position downstream of the valve leaflets to deliver the vascular device downstream of the valve leaflets.

11. The method of claim 1, wherein the delivery device is inserted through the jugular vein into the popliteal vein or the saphenous vein.

12. The method of claim 1, wherein the step of deploying the vascular device to an enlarged diameter comprises releasing the vascular device from the delivery device to enable it to return to a shape memorized condition and substantially simultaneously inflating a balloon.

13. The method of claim 12, further comprising the step of separating the balloon from the vascular device.

14. A method of approximating vein valve leaflets comprising:

inserting a vascular device of shape memory material in a collapsed configuration intravascularly to a target vessel;

actuating an expandable member to expand the vascular device to an expanded configuration to enable wall engaging members of the device to secure the internal vessel wall; and

contracting the expandable member to allow the vascular device to contract towards its memorized expanded configuration to bring the valve leaflets closer together.

15. The method of claim 14, further comprising the step of releasing the vascular device from a delivery device to enable it to return to its memorized expanded configuration prior to the step of actuating the expandable member.

16. The method of claim 15, wherein release of the vascular device from the delivery device causes a plurality of hooks to extend at an angle to a longitudinal axis of the delivery member in a direction to engage the vessel wall.

17. The method of claim 14, wherein contracting the expandable member returns the vascular device substantially to the memorized expanded configuration.

18. The method of claim 17, wherein the wall engaging members have penetrating tips and the step of actuating the expandable member causes the penetrating tips disposed on a proximal portion and a distal portion of the vascular device to securely grasp the internal vessel wall.

19. The method of claim 14, wherein the vascular device is inserted through the saphenous vein or the popliteal vein to a position downstream of the valve leaflets.

20. The method of claim 14, wherein the vascular device is inserted through the saphenous vein or the popliteal vein to a position upstream of the valve leaflets.

21. The method of claim 15, wherein release of the vascular device from a delivery sheath causes a middle portion of the vascular device to buckle radially outwardly thereby causing hooks extending therefrom to engage the vessel walls.

22. The method of claim 15, wherein the device returns to the memorized expanded configuration in response to exposure to body temperature, and the step of actuating the expandable member occurs substantially simultaneously with exposure of the device to body temperature.

23. The method of claim 22, wherein the expandable member is attached to the vascular device, and the step of actuating the expandable member automatically separates the expandable member from the vascular device.