Heart valve support device and methods for making and using the same
The disclosure relates to a device for supporting functions of a heart valve and methods for making and using the same. The device includes a flow optimizer configured to be located in the valve and having a cross sectional area that reduces a regurgitation orifice of the valve during systole. The device includes an anchoring mechanism coupled to the flow optimizer and configured to fix a position of the flow optimizer relative to the valve. The flow optimizer allows hemodynamic flow during diastole, minimizing risk of inducing atrioventricular pressure gradient and thrombogenesis, and seals or minimizes the regurgitation orifice during systole and reinstates efficacy of the valve. The anchoring system requires no traumatic interaction with the valve, atrium and ventricle. Implantation of the device can be achieved without invasive surgery. The device permits intra-procedural optimization of the positioning of the flow optimizer.
1 . A device for assisting with functioning of a cardiac valve, comprising:
an inner core; and
an anchoring mechanism connected to the inner core and configured to fix the device in the cardiac valve, the anchoring mechanism comprising one or more anchoring arms extending radially away from the inner core, wherein a first of the one or more anchoring arms is configured to rotate relative to a second of the one or more anchoring arms about the inner core and the one or more anchoring arms are further configured to individually expand and contract relative to a center axis of the anchoring mechanism to position the one or more anchoring arms at relative angles configured to match angles across commissures of leaflets of the cardiac valve.
2 . The device of claim 1 , further comprising a flow optimizer connected to the anchoring mechanism, wherein the flow optimizer is configured to collapse inwards during diastole and to expand at least partially outwards toward native valve leaflets of the cardiac valve during systole.
3 . The device of claim 1 , further comprising a flow optimizer connected to the anchoring mechanism, wherein the flow optimizer has a conical shape.
4 . The device of claim 1 , further comprising a flow optimizer connected to the anchoring mechanism, wherein the flow optimizer comprises a plurality of leaflet layers each arranged concentrically about a central axis of the flow optimizer.
5 . The device of claim 4 , wherein the plurality of leaflet layers comprises two or more leaflet layers, the two or more leaflet layers comprising first and second leaflet layers that at least partially overlap.
6 . The device of claim 5 , wherein the first and second leaflet layers are configured to open a gap to hemodynamic flow between the first and second leaflet layers during diastole.
7 . The device of claim 1 , wherein each of the one or more anchoring arms is configured to have a range of shape expansion and adapts to a geometry of an annulus of the cardiac valve at a commissure.
8 . The device of claim 1 , wherein a proximal end portion of the first anchoring arm comprises a cylindrical protrusion aligned with a central axis of the anchoring mechanism.
9 . The device of claim 8 , wherein a proximal end portion of the second anchoring arm is mated with the inner core, the inner core configured to be positioned within the cylindrical protrusion.
10 . The device of claim 1 , wherein the anchoring mechanism comprises a locking mechanism configured to fix relative positions among the one or more anchoring arms.
11 . The device of claim 1 , wherein the anchoring mechanism has a crimped conformation adapted to be loaded in a catheter and a deployed conformation upon deployment in the cardiac valve.
12 . The device of claim 1 , wherein the first of the one or more anchoring arms is configured to rotate starting from a symmetrical configuration of the one or more anchoring arms in one of a clockwise or counter-clockwise direction relative to the second of the one or more anchoring arms about the inner core.
13 . The device of claim 1 , wherein the one or more anchoring arms are further configured to individually expand and contract via a slider located along the one or more anchoring arms and configured to be longitudinally displaced in one of a distal or proximal direction and further to engage and disengage with a plurality of detents.
14 . The device of claim 13 , wherein the plurality of detents are configured to allow the longitudinal displacement of the slider in one or more of: a distal direction and a proximal direction.
15 . The device of claim 14 , wherein the distal direction corresponds to movement towards a ventricle and the proximal direction corresponds to movement towards an atrium.
16 . The device of claim 13 , further comprising an outer lumen coupled to the slider, further wherein the slider is a plurality of sliders including three sliders configured to control the individual expanding and contracting of the one or more anchoring arms.