Transcatheter mitral valve prosthesis
A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient's heart.
1 . A delivery system for a prosthetic heart valve, the system comprising:
a stationary inner guidewire shaft having a lumen extending therethrough;
a stationary hub shaft over the inner guidewire shaft and having a plurality of prosthesis engagement slots in an outer surface of and adjacent to a distal end of the hub shaft;
a movable bell shaft over the hub shaft and configured to cover the plurality of slots on condition that the bell shaft is disposed thereover;
a movable sheath over the bell shaft and configured to hold one or more portions of the prosthetic valve in a collapsed configuration between the sheath and the bell shaft on condition that the sheath is disposed thereover;
a handle adjacent a proximal end of the delivery system and having an actuator configured to move the bell shaft and the sheath to modulate engagement of the prosthetic valve with the delivery system; and
a pin lock coupled to the handle and configured to prevent proximal retraction of the sheath.
2 . The delivery system of claim 1 , wherein the inner guidewire shaft further comprises a tip configured to penetrate an apex of the patient's heart.
3 . The delivery system of claim 1 , wherein the inner guidewire shaft, the hub shaft, the bell shaft, and the sheath are concentric relative to one another.
4 . The delivery system of claim 1 , further comprising the prosthetic valve.
5 . The delivery system of claim 1 , wherein the actuator is a rotatable thumbwheel disposed in the handle.
6 . The delivery system of claim 1 , wherein actuation of the actuator in a first direction proximally retracts the sheath and the bell shaft, and wherein actuation of the actuator in a second direction opposite the first direction distally advances the sheath and the bell shaft.
7 . The delivery system of claim 6 , wherein actuation in the first direction proximally retracts the sheath first, followed by proximal retraction of the bell shaft, and wherein actuation in the second direction distally advances the bell shaft first, followed by distal advancement of the sheath.
8 . The delivery system of 1 , wherein the delivery system is configured to deliver the prosthetic heart valve transapically to the patient's heart.
9 . The delivery system of 1 , wherein a distal end of the bell catheter has a diameter larger than a proximal portion of the bell catheter.
10 . The delivery catheter of claim 1 , wherein the plurality of slots comprises three slots spaced circumferentially 120 degrees apart from one another.
11 . The delivery catheter of claim 1 , wherein proximal retraction of the bell catheter relative to the hub shaft removes a constraint from the plurality of slots allowing self-expansion of the portion of the prosthetic valve received in the plurality of slots, away from the plurality of slots.
12 . A delivery system for a prosthetic heart valve, the system comprising:
a stationary inner guidewire shaft having a lumen extending therethrough;
a stationary hub shaft over the inner guidewire shaft and having a plurality of prosthesis engagement slots in an outer surface of and adjacent to a distal end of the hub shaft, wherein the plurality of slots comprises three slots spaced circumferentially 120 degrees apart from one another;
a movable bell shaft over the hub shaft and configured to cover the plurality of slots on condition that the bell shaft is disposed thereover;
a movable sheath over the bell shaft and configured to hold one or more portions of the prosthetic valve in a collapsed configuration between the sheath and the bell shaft on condition that the sheath is disposed thereover; and
a handle adjacent a proximal end of the delivery system and having an actuator configured to move the bell shaft and the sheath to modulate engagement of the prosthetic valve with the delivery system.
13 . The delivery system of claim 12 , wherein the inner guidewire shaft further comprises a tip configured to penetrate an apex of the patient's heart.
14 . The delivery system of claim 12 , wherein the inner guidewire shaft, the hub shaft, the bell shaft, and the sheath are concentric relative to one another.
15 . The delivery system of claim 12 , further comprising the prosthetic valve.
16 . The delivery system of claim 12 , wherein the actuator is a rotatable thumbwheel disposed in the handle.
17 . The delivery system of claim 12 , wherein actuation of the actuator in a first direction proximally retracts the sheath and the bell shaft, and wherein actuation of the actuator in a second direction opposite the first direction distally advances the sheath and the bell shaft.
18 . The delivery system of claim 17 , wherein actuation in the first direction proximally retracts the sheath first, followed by proximal retraction of the bell shaft, and wherein actuation in the second direction distally advances the bell shaft first, followed by distal advancement of the sheath.
19 . The delivery system of 12 , wherein the delivery system is configured to deliver the prosthetic heart valve transapically to the patient's heart.
20 . The delivery system of 12 , wherein a distal end of the bell catheter has a diameter larger than a proximal portion of the bell catheter.
21 . The delivery catheter of claim 12 , wherein proximal retraction of the bell catheter relative to the hub shaft removes a constraint from the plurality of slots allowing self-expansion of the portion of the prosthetic valve received in the plurality of slots, away from the plurality of slots.