Vascular device with valve for approximating vessel wall

• US 9,675,474 B2
• Filed: 02/09/2014
• Issued: 06/13/2017
• Est. Priority Date: 06/26/2000
• Status: Expired due to Fees

• Current Assignee: REX Medical LP
• Original Assignee: REX Medical LP
• Inventors: McGuckin, Jr., James F., Hinchliffe, Peter W. J.
• Primary Examiner(s): SCHILLINGER, ANN M
• Application Number:
  US14/176,126
• Publication Number:
  US 20140155988A1
• Time in Patent Office: 1,220 Days
• 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 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 2/2433 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 vascular device for treating venous valve insufficiency by an intravascular approach to a target vessel, the device comprising a body and a plurality of vessel penetrating members extending radially from the body in a direction away from a longitudinal axis of the body, the body composed of shape memory material with a low profile insertion position of a first cross-sectional dimension, a shape memorized configuration being of a second reduced cross-sectional dimension but of larger cross-sectional dimension than the first cross sectional dimension and a vessel wall engagement position having a third cross-sectional dimension greater than the second cross-sectional dimension, the vessel engaging members having penetrating tips to penetrate the vessel wall and securely grasp the vessel wall for approximation of the wall, the body movable from the vessel wall engagement position, wherein the penetrating tips of the vessel engaging members penetrate to grasp the vessel wall, toward the shape memorized configuration to thereby bring the vessel wall radially inwardly so the vessel wall is changed from a first diameter to a second diameter, the second diameter being less than the first diameter, such reduction in diameter enabling the treatment of venous valve insufficiency by one of a) bringing the vessel wall to the second diameter such that existing valve leaflets extending radially inwardly from an internal portion of the vessel wall move closer together to thereby reduce a gap in the leaflets to prevent retrograde flow which gap otherwise is insufficient for proper closing of the valve which results in improper functioning of the valves such that retrograde blood flow is not prevented or b) implantation of a replacement valve extending from the vascular device and connected thereto and implanted with the vascular device to prevent retrograde blood flow as the replacement valve moves to a closed position.

2. The device of claim 1, wherein the device is expandable by a balloon positionable within an internal portion of the body.

3. The device of claim 1, wherein the penetrating tips include a hook having a piercing tip to prevent axial movement of the pierced vessel and a barb to restrict radial movement of the pierced vessel.

4. The device of claim 1, wherein the device is laser cut from a tube.

5. The device of claim 1, wherein the vascular device is positionable upstream of the leaflets of the vessel.

6. The device of claim 5, wherein exposure of the vascular device from the delivery member enables the body to expand from a collapsed insertion position.

7. The device of claim 1, wherein the vascular device is positionable downstream of the leaflets of the vessel.

8. The device of claim 7, wherein exposure of the vascular device from a delivery member enables the body to expand from a collapsed insertion position.

9. The device of claim 1, wherein the device includes a replacement valve having a closed position to prevent blood flow and an open position to enable blood flow therethrough, and a plurality of supports extending into the replacement valve which are movable to move the replacement valve between the closed and opened positions.

10. The device of claim 9, wherein the device is expandable by a balloon positionable within an internal portion of the body.

11. The device of claim 9, wherein the penetrating tips include a hook having a piercing tip to prevent axial movement of the pierced vessel and a barb to restrict radial movement of the pierced vessel.