VENOUS VALVE PROSTHESIS
A venous valve prosthetic implant for treatment of venous disease may include an expandable anchoring frame, a valve seat attached to the anchoring frame, a ball retention member attached to the anchoring frame, and a ball disposed within the lumen of the anchoring frame, between the valve seat and the ball retention member. The anchoring frame may include a first end, a second end, and a middle valve portion, where the middle valve portion expands to a smaller diameter than a diameter of either the first end or the second end. The ball may move back and forth within the middle valve portion, between a fully open position and a fully closed position.
1 . (canceled)
2 . A venous valve prosthetic implant for implantation in a vein for treatment of venous disease, the implant comprising:
an expandable anchoring frame comprising a first upstream end, a second downstream end, a middle valve portion between the first and second ends, and a lumen extending between the first and second ends; and
a collapsible ball disposed within the lumen of the anchoring frame, the ball being moveable within the middle valve portion between a closed position in which the ball prevents backflow of blood in an upstream direction through the implant and an open position in which the ball allows forward flow of blood in a downstream direction through the implant.
3 . The implant of claim 2 , wherein the anchoring frame comprises a tubular, stent-like lattice structure.
4 . The implant of claim 3 , wherein the middle valve portion expands to a smaller diameter than an expanded diameter of either the first end or the second end.
5 . The implant of claim 3 , wherein the second end expands to a larger diameter than an expanded diameter of the first end.
6 . The implant of claim 2 , further comprising a coating disposed over at least a portion of the anchoring frame.
7 . The implant of claim 6 , wherein the coating is made of at least one substance selected from the group consisting of polymers, hyaluronic acid, heparin and anticoagulant agents.
8 . The implant of claim 2 , wherein the ball prevents backflow of blood in the upstream direction by contacting a valve seat.
9 . The implant of claim 8 , wherein the valve seat is integrally formed with the anchoring frame.
10 . The implant of claim 8 , wherein the valve seat comprises a flexible polymer attached to an inner surface of the anchoring frame in the middle valve portion.
11 . The implant of claim 2 , further comprising a ball retention member that prevents the ball from passing out of the implant in the downstream direction.
12 . The implant of claim 11 , wherein the ball retention member comprises at least one suture member attached to the ball and to a location upstream of the ball.
13 . A venous valve prosthetic implant for implantation in a vein for treatment of venous disease, the implant comprising:
an expandable anchoring frame comprising a first upstream end, a second downstream end, a middle valve portion between the first and second ends, and a lumen extending between the first and second ends;
a ball disposed within the lumen of the anchoring frame, the ball being moveable between a closed position in which the ball prevents backflow of blood in an upstream direction through the implant and an open position in which the ball allows forward flow of blood in a downstream direction through the implant; and
a tether attached to the ball and to a location upstream of the ball to prevent the ball from passing out of the expandable anchoring frame in the downstream direction.
14 . The implant of claim 13 , wherein the anchoring frame comprises a superelastic nitinol frame.
15 . The implant of claim 14 , wherein the middle valve portion expands to a smaller diameter than an expanded diameter of either the first end or the second end.
16 . The implant of claim 15 , wherein the second end expands to a larger diameter than an expanded diameter of the first end.
17 . The implant of claim 13 , wherein the implant further comprises a coating disposed over at least a portion of the anchoring frame in the middle valve portion to seal against an inner vein wall, and a valve seat in the middle valve portion comprising a flexible polymer attached to an inner surface of the anchoring frame, wherein the ball prevents backflow of blood in the upstream direction by contacting the valve seat.
18 . The implant of claim 13 , wherein the anchoring frame and the ball are each self-expandable from a collapsed configuration, for delivery through a delivery catheter, to an expanded configuration upon release from the delivery catheter.
19 . The implant of claim 13 , wherein the tether comprises at least one of a suture material or nitinol.
20 . The implant of claim 13 , wherein the ball comprises a shell and a core.