Vascular device with valve for approximating vessel wall

• US 20090062901A1
• Filed: 08/07/2008
• Published: 03/05/2009
• Est. Priority Date: 08/31/2007
• Status: Active Grant

• Current Assignee: REX Medical LP
• Original Assignee: REX Medical LP
• Inventors: McGuckin, James F. JR.
• Granted Patent: US 8,834,551 B2
• Time in Patent Office: Days
• US Class Current: 623/1.150
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

A vascular device comprising a body movable from a collapsed insertion position to an expanded position having a larger cross-sectional dimension. The body includes a plurality of struts. At least two elongated struts extend distally from the body. A plurality of vessel engaging members extend outwardly from the body for engaging the internal wall of a vessel. A valve is movable between a collapsed delivery position and an expanded placement position, wherein at least a portion of the valve extends distally from the body in the delivery and placement positions and the elongated struts engage a distal portion of the valve in the placement position of the valve to retain the valve.

Claims

1. A vascular device comprising:

a body having a proximal portion and a distal portion and movable from a collapsed insertion position to an expanded position having a larger cross-sectional dimension, the body including a plurality of struts,

at least two elongated struts extending distally from the body; and

a plurality of vessel engaging members extending outwardly from the body for engaging the internal wall of a vessel; and

a valve movable between a collapsed delivery position and an expanded placement position, at least a portion of the valve extending distally from the body in the delivery and placement positions, wherein the elongated struts engage a distal portion of the valve in the placement position of the valve to retain the valve.

2. The vascular device of claim 1, wherein the vessel engaging members pull the internal wall of the vessel radially.

3. The vascular device of claim 2, wherein the body is composed of shape memory material and the expanded position substantially corresponds to a memorized position of the body, and the body is further expanded to a second expanded position by an expandable member.

4. The vascular device of claim 1, wherein in the collapsed position, the elongated struts extend external to at least a proximal portion of the valve.

5. The vascular device of claim 4, wherein in the collapsed position, a distal end of elongated struts extends over an edge of a distal portion of the valve.

6. The vascular device of claim 4, wherein the valve includes at least two openings and in the placement position, a portion of the elongated struts extends through the openings in the valve.

7. The vascular device of claim 6, wherein upon exposure of the valve from a delivery sheath, a portion of the valve is pulled proximally toward the body.

8. The vascular device of claim 1, further comprising an expandable ring positioned within the valve, wherein in the insertion position the ring is in a collapsed position.

9. The vascular device of claim 1, wherein the elongated struts have an inwardly angled strut portion extending toward a longitudinal axis of the valve.

10. A vascular device comprising:

a body having a proximal portion and a distal portion;

a valve extending distally from the body; and

a retraction member connected to the valve;

wherein the body and valve are movable between a collapsed insertion position within a delivery sheath to an expanded placement position exposed from the delivery sheath, the body and valve having a larger cross-sectional dimension in the placement position than in the collapsed position, wherein upon exposure from the delivery sheath, the retraction member applies a retraction force to the valve to pull the valve in a proximal direction.

11. The vascular device of claim 10, further comprising at least two elongated members extending distally of the body, wherein the elongated members are external to the valve as the valve is pulled proximally by the retraction member.

12. The vascular device of claim 10, wherein the retraction member comprises at least one shape memory wire.

13. The vascular device of claim 11, wherein the elongated members engage a distal portion of the valve to retain the valve.

14. The vascular device of claim 11, wherein the valve has a plurality of openings and wherein upon retraction of the valve, the elongated members extend through openings in the valve.

15. The vascular device of claim 10, further comprising an expandable ring contained within the valve, the expandable ring applying a radial force to the valve to force the valve against a vessel wall.

16. The vascular device of claim 11, wherein a distal portion of the elongated members extend radially inwardly toward a longitudinal axis of the valve.

17. The vascular device of claim 11, wherein at least one of the elongated members is attached to the valve.

18. The vascular system of claim 10, wherein the body is composed of a shape memory material and is expandable first to a memorized condition in response to exposure to body temperature and subsequently expanded to the expanded position by an expandable member.

19. A method for treating venous valve insufficiency comprising:

inserting into a target vessel adjacent the region of the removed portion of valve leaflets a delivery device and a vascular device in an insertion position within the delivery device, the vascular device including a body, a plurality of vessel engaging members extending from the body, a valve, and a retraction member connected to the valve, wherein in the insertion position the body, retraction member and valve are in a reduced transverse dimensional configuration with at least a portion of the valve positioned distal of the body; and

exposing the vascular device from the delivery device, wherein the exposure enables the retraction member to move the valve in a proximal direction and the exposure enables the body to expand to enable the vessel engaging members to engage the internal wall of the vessel

20. The method of claim 19, wherein in the insertion position, at least a portion of the retraction member is positioned proximal of the valve.

21. The method of claim 20, wherein in the insertion position the vascular device has a first overall length and after the retraction member self coils, the vascular device has a second overall length less than the first overall length.