Heart valve support device
Devices for assisting with the functioning of a tricuspid valve of a heart include a shaft, a flow optimizer, and an anchoring mechanism. A tilting mechanism can be configured to tilt the shaft relative to a central axis of the anchoring mechanism. Leaflets (e.g., multi-layer leaflets) of the flow optimizer can include a membrane and a rim, and the rim can have a higher stiffness than the membrane.
1. A device for assisting with functioning of a tricuspid valve of a heart, comprising:
a shaft;
a flow optimizer fixedly connected to a distal end of the shaft;
an anchoring mechanism comprising a core having a socket therein; and
a ball positioned within the socket, the ball having a lumen therein through which the shaft is configured to extend, wherein the ball is configured to rotate within the socket so as to tilt the shaft relative to a central axis of the anchoring mechanism.
2. The device of claim 1 , wherein the shaft is configured to slide axially and rotate within the lumen.
3. The device of claim 1 , wherein the core comprises an angled ledge configured to limit an angle of the flow optimizer relative to the anchoring mechanism.
4. The device of claim 3 , wherein the angle is less than 45 degrees.
5. The device of claim 1 , further comprising a locking mechanism configured to lock an angle of tilt of the flow optimizer relative to the anchoring mechanism.
6. The device of claim 5 , wherein the locking mechanism is further configured to lock an axial and rotational position of the flow optimizer relative to the anchoring mechanism.
7. The device of claim 5 , wherein the locking mechanism comprises one or more screws configured to extend through the core and engage the ball.
8. The device of claim 5 , wherein the locking mechanism comprises an annular lock configured to fit between the core and the ball.
9. The device of claim 8 , wherein the annular lock is configured to move axially between a proximal position in which the ball is configured to rotate and a distal position in which the ball is fixed.
10. The device of claim 8 , wherein the annular lock is a snap fit lock.
11. The device of claim 8 , wherein the annular lock includes threaded grooves configured to mate with threaded grooves on an inner surface of the core.
12. The device of claim 1 , wherein the flow optimizer comprises a frame and a plurality of leaflets attached to the frame.
13. The device of claim 12 , wherein the plurality of leaflets are configured to expand to an expanded configuration during systole to block a flow of blood around the flow optimizer and to collapse to a collapsed configuration during diastole to allow a flow of blood around the flow optimizer.
14. The device of claim 1 , wherein the anchoring mechanism further comprises a plurality of anchoring arms extending radially away from the core.
15. A method of assisting with functioning of a tricuspid valve of a heart, comprising:
inserting a tricuspid valve device into a native tricuspid valve, wherein the tricuspid valve device comprises a shaft, a flow optimizer, and an anchoring mechanism;
fixing the anchoring mechanism at commissures leaflets of the native tricuspid valve; and
tilting the shaft relative to a central axis of the anchoring mechanism so as to position the flow optimizer at a desired angular position within the native tricuspid valve.
16. The method of claim 15 , wherein tilting the shaft comprises rotating a ball within a socket of the tricuspid valve device.
17. The method of claim 15 , further comprising:
during diastole, reducing a cross-sectional area of the flow optimizer to allow hemodynamic flow around and through the flow optimizer; and
during systole, increasing a cross-sectional area of the flow optimizer to seal an orifice of the native tricuspid valve.
18. The method of claim 15 , further comprising axially moving the shaft relative to the anchoring mechanism after fixing the anchoring mechanism so as to position the flow optimizer at a desired axial position within the native tricuspid valve.
19. The method of claim 15 , further comprising rotating the shaft relative to the anchoring mechanism after fixing the anchoring mechanism so as to position the flow optimizer at a desired rotational position within the native tricuspid valve.
20. The method of claim 15 , further comprising locking the flow optimizer at the desired angular position with a locking mechanism.
21. The method of claim 20 , wherein the locking mechanism further locks an axial and rotational position of the flow optimizer relative to the anchoring mechanism.
22. The method of claim 20 , wherein the locking mechanism comprises one or more screws configured to extend through the core and engage with the ball.
23. The method of claim 20 , wherein the locking mechanism comprises an annular lock configured to fit around the shaft.
24. The method of claim 23 , wherein locking comprises distally moving the annular lock relative to the anchoring mechanism.
25. The method of claim 23 , wherein locking comprises rotating the annular lock relative to the anchoring mechanism.