Vascular device with valve for approximating vessel wall

• US 8,834,551 B2
• Filed: 08/07/2008
• Issued: 09/16/2014
• Est. Priority Date: 08/31/2007
• Status: Active Grant

• Current Assignee: REX Medical LP
• Original Assignee: REX Medical LP
• Inventors: McGuckin, James F. Jr.
• Primary Examiner(s): Holwerda, Kathleen
• Assistant Examiner(s): ALEMAN, SARAH WEBB
• Application Number:
  US12/221,911
• Publication Number:
  US 20090062901A1
• Time in Patent Office: 2,231 Days
• Field of Search: 623/1.23, 623/1.26, 623/1.11, 623/1.13, 623/2.11
• US Class Current: 623/1.11
• 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 formed from a tubular member and having a proximal portion and a distal portion and movable from a collapsed delivery position to an expanded placement position having a larger cross-sectional dimension, the body including a plurality of first struts forming a plurality of cells;

at least two elongated struts formed from the tubular member and integral with the first struts, the at least two elongated struts extending distally from the plurality of cells, and each elongated strut having a portion extending radially inwardly to extend transverse to a longitudinal axis of the device in an unconstrained position;

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, in the collapsed delivery position the valve spaced distally of the plurality of cells, at least a portion of the valve extending distally from a distal portion of the body in the placement position, wherein the elongated struts are positioned external of the valve and engage and lie over a distalmost edge of the valve in the placement position of the valve to retain the valve, the vessel engaging members positioned proximal of the valve, the valve engaged by the radially inwardly extending portions of the at least two elongated struts.

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 the radially inwardly extending portions are at a distal end of the elongated struts and wherein in the collapsed position, the radially inwardly extending portions of elongated struts extend over an edge of a distal portion of the valve.

6. The vascular device of claim 1, wherein upon exposure of the valve from a delivery sheath, a portion of the valve is pulled proximally toward the body.

7. 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.

8. The vascular device of claim 1, wherein the collapsed insertion position, the retraction member defines a loop positioned proximal and external of the valve.

9. A vascular device comprising:

a body having a proximal portion and a distal portion;

a valve extending distally from the body and having openings in a sidewall;

a retraction member connected to the valve and having a first longitudinal length in a first extended position and a second smaller longitudinal length in a second retracted position; and

at least two elongated struts extending radially inwardly and external of 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 is movable in a proximal direction relative to the body from the first extended position for delivery to the second retracted position to apply a retraction force to the valve to pull the valve in a proximal direction such that the valve is closer to the body in the retracted position of the retraction member than in the extended position of the retraction member, wherein the elongated struts are out of engagement with the openings of the valve in the insertion position and are in engagement with the openings in the placement position.

10. The vascular device of claim 9, wherein the at least two elongated struts extend distally of the body, wherein the elongated struts are external to the valve as the valve is pulled proximally by the retraction member.

11. The vascular device of claim 10, wherein the elongated struts engage a distal portion of the valve to retain the valve.

12. The vascular device of claim 10, wherein a distal portion of the elongated struts extend radially inwardly toward a longitudinal axis of the valve.

13. The vascular device of claim 10, wherein at least one of the elongated struts is attached to the valve in the placement position.

14. The vascular device of claim 9, wherein the retraction member comprises at least one shape memory wire.

15. The vascular device of claim 9, 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 system of claim 9, 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.

17. The method of claim 9, wherein in the retracted position the retraction member is a wire forming a ring shape to apply a radial force against the valve.

18. 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, at least two elongated struts extending from the 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 the retraction member defines a loop in the insertion position, the loop is positioned between the body and the valve such that it is proximal and external of the valve in the insertion position; and

exposing the vascular device from the delivery device, wherein when exposed the retraction member moves in a proximal direction relative to the body toward the vessel engaging members, from an extended position to a retracted position to move the valve in a proximal direction and when exposed the body expands to enable the vessel engaging members to engage the internal wall of the vessel, wherein in the retracted position of the retraction member the valve is closer to the body than in the extended position of the retraction member.

19. The method of claim 18, wherein in the insertion position, at least a portion of the retraction member is positioned proximal of the valve.

20. The method of claim 19, 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.