Vascular device with valve for approximating vessel wall

• US 6,676,698 B2
• Filed: 12/05/2001
• Issued: 01/13/2004
• 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., Hinchliffe, Peter W. J.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Phan, Hieu
• Application Number:
  US10/011,345
• Publication Number:
  US 20020055772A1
• Time in Patent Office: 769 Days
• Field of Search: 623/1.36, 623/1.14, 623/1.15, 623/1.11, 623/1.23, 623/1.19, 623/232, 623/236, 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 17/12036 partial occlusion
• 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
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• 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 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

A vascular device comprising a plurality of vessel engaging members and a valve. The device is movable from a collapsed insertion position having a first diameter to a second expanded position having a second diameter larger than the first diameter. The plurality of vessel engaging members extend outwardly from the device for securely engaging the internal wall of a vessel upon expansion of the device to the second expanded position, wherein the vessel engaging members pull the internal wall of the vessel radially inwardly upon movement of the device from the second expanded position toward a first expanded position having a third diameter greater than the first diameter and less than the second diameter. In the first expanded position the valve is movable between an open position to allow blood flow therethrough to a closed position to prevent blood flow.

Claims

1. A method for treating venous valve insufficiency comprising:

inserting a delivery device and a vascular device having a replacement valve into a target vessel adjacent the region of the removed portion of leaflets;

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 to reduce dilation of the vessel and implant the replacement valve.

2. The method of claim 1, further comprising the step of removing at least a portion of vein valve leaflets of a patient prior to deploying the vascular device.

3. The method of claim 2, wherein the step of the deploying the vascular device to an enlarged diameter includes the step of moving a plurality of vessel engaging members of the vascular device to penetrate the vessel wall and retain the device.

4. 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 step of deploying the vascular device to a first diameter including 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, the first expanded diameter being less than the enlarged diameter, and the step of reducing the diameter of the vascular device returns the device to a diameter substantially equal to the first expanded diameter.

5. The method of claim 4, further comprising the step of removing at least a portion of vein valve leaflets of a patient prior to deploying the vascular device.

6. The method of claim 5, wherein the delivery device is inserted into the popliteal vein in a retrogade fashion.

7. 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, the step of inflating the balloon enabling a plurality of vessel engaging members of the vascular device to penetrate the vessel wall and retain the device.

8. The method of claim 7, wherein the vascular device is composed of stainless steel and the step of deploying the vascular device expands the device below its elastic limit to enable it to return to its reduced diameter when the balloon is deflated.

9. The method of claim 7, further comprising the step of releasing the device from the balloon.

10. The method of claim 1, wherein the vascular device is composed of stainless steel and the step of deploying the vascular device expands the device below its elastic limit to enable it to return to its reduced diameter when the balloon is deflated.

11. The method of claim 1, wherein the delivery device is inserted through the jugular vein or the femoral 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 1, wherein the step of deploying the vascular device to an enlarged diameter includes the step of moving a plurality of vessel engaging members of the vascular device to penetrate the vessel wall and retain the device.

14. 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 wherein the expandable member is attached to the vascular device, and the step of actuating the expandable member automatically separates the expandable member the vascular device.

15. 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.

16. The method of claim 15, wherein the step of deploying the vascular device to an enlarged diameter also includes the step of inflating a balloon positioned within the device.