SYSTEMS, DEVICES, AND METHODS FOR REDUCING HEART VALVE REGURGITATION
Embodiments described herein relate to an implant delivery system for delivering an implant for reducing heart valve regurgitation. The implant delivery system may include an implant catheter disposed in an inner lumen of a guide catheter. The implant catheter may include one or more hypotubes disposed therein, each hypotube configured to receive an elongate member such as a braided tether. A distal end of the implant catheter may be coupled to an implant holder configured to receive the implant. The implant holder may define one or more channels, each channel configured to receive a portion of a respective elongate member. The elongate members configured to couple the implant to the implant holder and transition the implant between configurations. The implant configured to be disposed around a portion of a leaflet of a heart valve to improve coaptation of the heart valve.
1 . A system, comprising:
an implant configured to be coupled to a native heart valve leaflet of a heart of a patient to reduce valve regurgitation, the implant including (1) an atrial arm and a ventricular arm collectively movable between a closed position and an open position and defining a space sufficient to capture a portion of the native heart valve leaflet between the atrial arm and the ventricular arm and (2) a leaflet enhancer, the ventricular arm being configured to move laterally relative to the atrial arm to define the space;
an implant catheter including an implant holder at a distal end thereof, the implant holder configured to hold the implant to form a distal assembly, the implant holder including an engagement surface,
when the implant is in a delivery configuration, at least one of the atrial arm and the ventricular arm is configured to abut the engagement surface and the leaflet enhancer is configured to extend distal to the engagement surface, a maximum lateral dimension of the distal assembly being defined by the implant when the implant is in the closed position.
2 . The system of claim 1 , wherein the implant holder includes a proximal portion and a distal portion defining an opening therebetween, the implant holder including a connector configured to extend across the opening to connect the proximal portion and the distal portion, a portion of the leaflet enhancer is configured to extend laterally beyond the connector and a perimeter defined by the implant holder.
3 . The system of claim 1 , wherein the implant holder includes a proximal portion and a distal portion defining an opening therebetween, a distance between a distal end of the implant and the distal portion of the implant holder is such that a moment arm for moving the ventricular arm to the open position is above a predetermined value with a lower force.
4 . The system of claim 1 , wherein the implant holder includes a proximal portion and a distal portion defining an opening therebetween, the proximal portion of the implant holder defines a shape corresponding to a shape of the implant such that the implant sits in the opening.
5 . The system of claim 1 , wherein the implant holder includes a proximal portion and a distal portion defining an opening therebetween, the distal portion of the implant holder includes an atraumatic distal end.
6 . The system of claim 1 , further comprising:
a first tether configured to be removably coupled to the atrial arm; and
a second tether configured to be removably coupled to the ventricular arm.
7 . The system of claim 6 , wherein tension applied to a proximal portion of the first tether moves the atrial arm of the implant toward the engagement surface.
8 . The system of claim 6 , wherein tension applied to a proximal portion of the second tether, and while the atrial arm of the implant abuts the engagement surface based on tension applied to the proximal portion of the first tether, moves the ventricular arm of the implant away from the atrial arm of the implant, thereby transitioning the implant towards the open position.
9 . The system of claim 8 , wherein tension released from the proximal portion of the second tether moves the ventricular arm of the implant closer to the atrial arm of the implant, thereby transitioning the implant from the open position towards the closed position.
10 . The system of claim 6 , wherein implant holder defines a plurality of channels including a first pair of channels and a second pair of channels, the first pair of channels configured to slidably receive a respective portion of the first tether, and the second pair of channels configured to slidably receive a respective portion of the second tether.
11 . The system of claim 1 , wherein the implant catheter is configured to be manipulated to position the implant within a gap defined between the native heart valve leaflet and another native leaflet of the heart valve such that a level of regurgitation can be determined by performing at least one of fluoroscopy imaging or echocardiography (1) while the implant remains coupled to the implant catheter and is positioned within the gap, and (2) before the implant captures the native heart valve leaflet between the atrial arm and the ventricular arm.
12 . The system of claim 11 , wherein a level of regurgitation after the implant captures the native heart valve leaflet can be determined by performing at least one of fluoroscopy imaging or echocardiography.
13 . The system of claim 12 , wherein the level of valve regurgitation determined before the implant captures the native heart valve leaflet is substantially similar to the level of valve regurgitation determined after the implant captures the native heart valve leaflet between the atrial arm and the ventricular arm.
14 . The system of claim 1 , wherein the space between the atrial arm and the ventricular arm is sufficient to capture a length of the native heart valve leaflet.
15 . A system, comprising:
an implant configured to be to delivered to a native heart valve leaflet of a heart of a patient to reduce valve regurgitation through a gap within a native heart valve, the implant including (1) an atrial arm and a ventricular arm collectively movable between a closed position and an open position and defining a space sufficient to capture a portion of the native heart valve leaflet between the atrial arm and the ventricular arm, and (2) a leaflet enhancer, the ventricular arm being configured to move laterally relative to the atrial arm to define the space; and
an implant catheter including an implant holder at a distal end thereof, the implant holder configured to hold the implant to form a distal assembly, the implant holder defining a plurality of channels including a first pair of channels and a second pair of channels, the first pair of channels configured to slidably receive a portion of a first tether, and the second pair of channels configured to slidably receive a portion of a second tether, the first tether removably coupleable to the atrial arm and the second tether removably coupleable to the ventricular arm.
16 . The system of claim 15 , wherein the implant holder further comprises engagement surface, the atrial arm and the ventricular arm configured to abut the engagement surface when the implant is in a delivery configuration.
17 . The system of claim 16 , wherein tension applied to a proximal portion of the first tether moves the atrial arm of the implant toward the engagement surface.
18 . The system of claim 15 , wherein tension applied to a proximal portion of the second tether, after the atrial arm of the implant abuts the engagement surface, moves the ventricular arm of the implant away from the atrial arm of the implant, thereby transitioning the implant towards the open position.
19 . The system of claim 18 , wherein tension released from the proximal portion of the second tether moves the ventricular arm of the implant closer to the atrial arm of the implant, thereby transitioning the implant from the open position towards the closed position.
20 . The system of claim 15 , wherein the plurality of channels are configured to receive a flushing fluid from a fluid source to prevent blood clots from forming therein.
21 . The system of claim 15 , wherein the implant holder includes a proximal portion and a distal portion defining an opening therebetween, the proximal portion defining the first pair of channels and the second pair of channels, the distal portion defining a third pair of channels configured to slidably receive a second portion of the second tether.
22 . A system, comprising:
an implant configured to be coupled to a native heart valve leaflet of a heart of a patient to reduce valve regurgitation, the implant including (1) an atrial arm and a ventricular arm collectively movable between a closed position and an open position and defining a space sufficient to capture a portion of the native heart valve leaflet between the atrial arm and the ventricular arm, and (2) a leaflet enhancer; and
an implant catheter including an implant holder at a distal end thereof, the implant holder configured to hold the implant to form a distal assembly, the implant holder including a proximal portion and a distal portion defining an opening therebetween, the implant holder defining a plurality of channels, each channel of the plurality of channels configured to receive a respective portion of a plurality of tethers such that each of the plurality of tethers partially extends outside of the implant holder and across the opening.
23 . The system of claim 22 , wherein the implant holder includes a connector configured to extend across the opening to connect the proximal portion and the distal portion.
24 . The system of claim 23 , wherein the connector includes at least one hypotube.
25 . The system of claim 23 , wherein the connector is configured such that a length between the proximal portion and the distal portion is adjustable.
26 . The system of claim 23 , wherein the implant is configured to be coupled to the implant holder such that a portion of the leaflet enhancer extends laterally beyond the connector and a perimeter defined by the implant holder such that the implant defines a maximum lateral dimension of the distal assembly.
27 . The system of claim 22 , wherein the first tether is configured to be removably coupled to the atrial arm and the second tether is configured to be removably coupled to the ventricular arm.
28 . The system of claim 27 , wherein the implant holder further comprises engagement surface, the atrial arm and the ventricular arm configured to abut the engagement surface when the implant is in a delivery configuration.
29 . The system of claim 28 , wherein tension applied to a proximal portion of the first tether moves the atrial arm of the implant toward the engagement surface.
30 . The system of claim 29 , wherein tension applied to a proximal portion of the second tether moves the ventricular arm of the implant away from the atrial arm of the implant, thereby transitioning the implant towards the open position.