Method and apparatus for percutaneous delivery and deployment of a cardiac valve prosthesis
Catheter apparatuses and methods are provided for repairing heart valves, particularly mitral valves. The method includes providing a catheter having an elongate, flexible body, with a proximal end and a distal end. The distal end can be transluminally advanced from the left atrium through the mitral valve. A distal anchor zone or portion coupled with the proximal end can extend and along the left ventricular outflow tract into the ascending aorta. A valve repair device is deployed to permanently connect leaflets at a mid-section of a mitral valve while permitting medial and lateral portions of the natural leaflets to open and close. The catheter apparatuses may be positionable using a steering device. The valve repair device detachably connects the distal and proximal ends of the catheter. The valve repair device can be detached using low profile devices actuatable from the proximal or distal ends, e.g., at a venous or arterial access site.
1. A system for deploying a mitral prosthesis, comprising:
an elongate catheter body assembly comprising a venous portion and an arterial portion having a length disposed between a proximal end of the arterial portion and a distal end of the arterial portion, the elongate catheter body assembly sized to extend from a peripheral venous access site to a heart and from the heart to a peripheral arterial access site;
a mitral prosthesis disposed between and coupled to the venous portion of the elongate catheter body assembly and the arterial portion of the elongate catheter body assembly to provide an outer profile defined by an outer surface of the venous portion, an outer surface of the mitral prosthesis, and an outer surface of the arterial portion, wherein a distal end of the venous portion is coupled to a proximal end of the mitral prosthesis radially inward of the outer profile and a proximal end of the arterial portion is coupled to a distal end of the mitral prosthesis radially inward of the outer profile, wherein the arterial portion of the elongate catheter body assembly is configured to detachably couple from the distal end of the mitral prosthesis, wherein when the system is disposed in a patient with the mitral prosthesis positioned at a mitral valve for deployment, the length of the arterial portion extends from the heart to the peripheral arterial access site; and
a first control device disposed in the venous portion of the elongate catheter body assembly to facilitate angulation of the mitral prosthesis from a venous end;
wherein the mitral prosthesis can be positioned by manipulation of one or both of the venous portion and the arterial portion and the mitral prosthesis can be angled by the first control device.
2. The system of claim 1 , wherein the first control device comprises a tension member disposed in a peripheral lumen of the venous portion.
3. The system of claim 1 , further comprising a second control device disposed in the venous portion to facilitate remote deployment of each of a plurality of grasping elements of the mitral prosthesis.
4. The system of claim 1 , further comprising a detachment actuator configured to separate the mitral prosthesis from at least one of the venous portion and the arterial portion of the elongate catheter body assembly.
5. The system of claim 1 , wherein the mitral prosthesis includes a base and at least one tissue grasper.
6. The system of claim 5 , wherein the at least one tissue grasper is covered by a fabric material.
7. The system of claim 1 , further comprising a guidewire configured to extend through the venous portion of the elongate catheter body assembly from the venous end to support an anchor portion of the elongate catheter body assembly.
8. The system of claim 1 , wherein the arterial portion comprises a tapered portion coupled to the mitral prosthesis and the arterial portion, the tapered portion configured to provide a progressively smaller profile in a direction from the mitral prosthesis toward a distal end of the arterial portion.
9. The system of claim 8 , wherein a proximal face of the tapered portion is configured to detach from the mitral prosthesis without disrupting a securement of the mitral prosthesis to a heart valve leaflet.
10. The system of claim 8 , wherein the tapered portion is integrated into the mitral prosthesis.
11. The system of claim 1 further comprising:
the mitral prosthesis, comprising:
an elongate body, wherein the distal end comprises a distal interface and the proximal end comprising a proximal interface, the distal interface adapted to reversibly couple with the arterial portion of the elongate catheter body assembly while the proximal interface remains coupled to the venous portion of the elongate catheter body assembly;
an arcuate anterior leaflet grasping element articulated at the distal end of the elongate body, the arcuate anterior leaflet grasping element being movable between an open position and a closed position; and
an arcuate posterior leaflet grasping element articulated at the distal end of the elongate body, the arcuate posterior leaflet grasping element being movable between an open position and a closed position.
12. The system of claim 11 , wherein the arcuate anterior leaflet grasping element is configured to be actuated independently of the arcuate posterior leaflet grasping element.
13. The system of claim 11 , wherein when the arcuate posterior leaflet grasping element is in the closed position the arcuate posterior leaflet grasping element is received in a space at least partially bounded by a base of the elongate body.
14. The system of claim 11 , wherein at least one of the arcuate anterior leaflet grasping element and the arcuate posterior leaflet grasping element comprises a control member disposed in a channel, a grasping face, and an elastically deformable region coupled with the grasping face and the control member.
15. A system for deploying a mitral prosthesis, comprising:
an elongate catheter body assembly comprising a venous portion and an arterial portion, the elongate catheter body assembly sized to extend from a peripheral venous site, through a heart, to a peripheral arterial site and when so extended, the venous portion traverses the peripheral venous site while the arterial portion traverses the peripheral arterial site;
a mitral prosthesis disposed between and coupled to the venous portion of the elongate catheter body assembly and the arterial portion of the elongate catheter body assembly to provide an outer profile defined by an outer surface of the venous portion, an outer surface of the mitral prosthesis, and an outer surface of the arterial portion, wherein a distal end of the venous portion is coupled to a proximal end of the mitral prosthesis radially inward of the outer profile and a proximal end of the arterial portion is coupled to a distal end of the mitral prosthesis radially inward of the outer profile, wherein the arterial portion of the elongate catheter body assembly is configured to detachably couple from the distal end of the mitral prosthesis; and
a first control device disposed in the venous portion of the elongate catheter body assembly to facilitate angulation of the mitral prosthesis from a venous end;
wherein the mitral prosthesis can be positioned by manipulation of one or both of the venous portion and the arterial portion and the mitral prosthesis can be angled by the first control device,
wherein the arterial portion comprises a tapered portion coupled to the mitral prosthesis and the arterial portion, the tapered portion configured to provide a progressively smaller profile in a direction from the mitral prosthesis toward a distal end of the arterial portion, and
wherein an outer surface of the tapered portion encloses an expandable cavity that can be filled with an inflation medium.
16. A system for deploying a mitral prosthesis, comprising:
a distal portion, a proximal portion, and a length disposed between the distal portion and the proximal portion, the length sized to extend from a peripheral venous access site to a heart and from the heart to a peripheral arterial access site;
a mitral prosthesis disposed between a proximal end of the distal portion and a distal end of the proximal portion, wherein the distal end of the proximal portion is coupled to a proximal end of the mitral prosthesis and the proximal end of the distal portion is coupled to a distal end of the mitral prosthesis to provide a continuous outer profile defined by an outer surface of the proximal portion, an outer surface of the mitral prosthesis, and an outer surface of the distal portion when the system is introduced into a delivery path and as the mitral prosthesis is advanced to a deployment location, wherein when the system is disposed in a patient with the mitral prosthesis positioned at a mitral valve for deployment. a length of the distal portion extends from the heart to the peripheral arterial access site; and
a detachment actuator configured to separate the proximal end of the distal portion from the distal end of the mitral prosthesis,
wherein the mitral prosthesis can be positioned by manipulation of one or both of the distal portion and the proximal portion of the system.
17. The system of claim 16 , further comprising a control device disposed in the proximal portion to facilitate angulation of the mitral prosthesis.
18. The system of claim 16 , wherein the distal portion comprises a tapered portion coupled to the mitral prosthesis, the tapered portion configured to provide a progressively smaller profile in a direction from the mitral prosthesis toward a distal end of the distal portion.
19. The system of claim 18 , wherein a proximal face of the tapered portion is configured to detach from the mitral prosthesis without disrupting a securement of the mitral prosthesis to a heart valve leaflet.