Implantable heart valve devices, mitral valve repair devices and associated systems and methods

Abstract

Systems, devices and methods for repairing a native heart valve. In one embodiment, a repair device for repairing a native mitral valve having an anterior leaflet and a posterior leaflet between a left atrium and a left ventricle comprises a support having a contracted configuration and an extended configuration. In the contracted configuration, the support is sized to be inserted under the posterior leaflet between a wall of the left ventricle and chordae tendineae. In the extended configuration, the support is configured to project anteriorly with respect to a posterior wall of the left ventricle by a distance sufficient to position at least a portion of the posterior leaflet toward the anterior leaflet.

What is claimed is: 
     
         1 . A mitral valve repair device, comprising:
 a frame comprising a shape memory material; and   an extension unit positioned around at least a portion of the frame, the extension unit comprising a flexible material configured to move from a contracted configuration for delivery to an expanded configuration, the extension unit having an inner volume configured to be filled with blood in the expanded configuration, and the extension unit configured to extend inwardly toward a central axis of an orifice of a native mitral valve to close a gap relative to a free edge of an anterior leaflet of the native mitral valve in the expanded configuration.   
     
     
         2 . The mitral valve repair device of  claim 1 , wherein the flexible material comprises a cover, and wherein the cover is configured to enable tissue ingrowth. 
     
     
         3 . The mitral valve repair device of  claim 1 , wherein, when in the contracted configuration, the frame and the extension unit are sized to fit within a delivery catheter. 
     
     
         4 . The mitral valve repair device of  claim 1 , wherein the extension unit comprises a fluid absorbing material within the inner volume. 
     
     
         5 . The mitral valve repair device of  claim 4 , wherein the fluid absorbing material comprises a foam. 
     
     
         6 . The mitral valve repair device of  claim 4 , wherein the fluid absorbing material comprises a hydrogel. 
     
     
         7 . The mitral valve repair device of  claim 4 , wherein, when in contact with the blood, the fluid absorbing material is configured to expand to inflate the extension unit from the contracted configuration to the expanded configuration. 
     
     
         8 . The mitral valve repair device of  claim 1 , wherein the extension unit is configured to push at least a portion of a posterior leaflet of the native mitral valve toward the anterior leaflet of the native mitral valve. 
     
     
         9 . The mitral valve repair device of  claim 1 , wherein the extension unit comprises an inflatable bladder within the inner volume and extending the extension unit comprises injecting the blood into the inflatable bladder. 
     
     
         10 . The mitral valve repair device of  claim 1 , wherein the frame is configured to, in response to deployment from a delivery catheter, move from a collapsed configuration toward a deployed configuration, and wherein, when in the deployed configuration, the frame is configured to press against an underside of a posterior leaflet of the native mitral valve. 
     
     
         11 . The mitral valve repair device of  claim 1 , wherein the extension unit comprises a plurality of projections and a plurality of depressions, each depression being disposed between two of the projections, wherein at least some of the projections are configured to engage an underside of a posterior leaflet of the native mitral valve, and wherein at least some of the depressions are configured to receive chordae tendineae coupled to the underside of the posterior leaflet. 
     
     
         12 . A method of repairing a native mitral valve having an anterior leaflet and a posterior leaflet between a left atrium and a left ventricle, comprising:
 implanting a mitral valve repair device under the posterior leaflet, wherein the mitral valve repair device comprises:
 a frame defined by a shape memory material; and 
 an extension unit positioned around at least a portion of the frame, the extension unit comprising a flexible material configured to move from a contracted configuration for delivery to an expanded configuration; and 
   inflating, with blood, an inner volume of the extension unit to move the flexible material from the contracted configuration to the expanded configuration and to extend inwardly toward a central axis of the valve orifice to close a gap relative to a free edge of an anterior leaflet of a native mitral valve in the expanded configuration.   
     
     
         13 . The method of  claim 12 , wherein positioning the mitral valve repair device under the posterior leaflet comprises positioning the extension unit in the contracted configuration under the posterior leaflet, and wherein inflating the at least one pocket comprises expanding the cover to presses against a wider portion of the posterior leaflet in the expanded configuration relative to the contracted configuration. 
     
     
         14 . The method of  claim 12 , wherein the method further comprises, before inflating the at least one pocket, releasing the frame from a collapsed configuration such that the frame moves toward a deployed configuration to press against an underside of the posterior leaflet. 
     
     
         15 . The method of  claim 12 , wherein the extension unit comprises a plurality of projections and a plurality of depressions, each depression being disposed between two of the projections, and wherein inflating the at least one pocket comprises extending the projections along an underside of the posterior leaflet such that an upper side of the projections presses against the posterior leaflet and the chordae tendineae are positioned in at least some of the depressions. 
     
     
         16 . The method of  claim 12 , wherein inflating the at least one pocket further comprises closing a gap relative to free edges of the posterior leaflet and the anterior leaflet. 
     
     
         17 . A medical system for repairing a native valve of a patient, the system comprising:
 a delivery catheter extending from a proximal portion controllable by a clinician to a distal portion introducible into a vasculature of a patient; and   a valve repair device positioned within the distal portion of the delivery catheter, wherein the valve repair device comprises:
 a frame defined by a shape memory material; and 
 an extension unit positioned around at least a portion of the frame, the extension unit comprising a flexible material configured to move from a contracted configuration for delivery to an expanded configuration, the extension unit having an inner volume configured to be filled with blood in the expanded configuration, 
   wherein the delivery catheter is configured to deploy the valve repair device in the contracted configuration into a subannular position behind at least one leaflet of a native valve connected to chordae tendineae, and   wherein the extension unit, when in the expanded configuration, is configured to extend inwardly toward a central axis of an orifice of the native valve to close a gap relative to a free edge of the at least one leaflet of the native valve in the expanded configuration.   
     
     
         18 . The medical system of  claim 17 , wherein the native valve is a mitral valve, and wherein the heart wall is a left ventricular wall and the leaflet is a posterior mitral valve leaflet. 
     
     
         19 . The medical system of  claim 17 , wherein the chordae tendineae are basal or tertiary chordae tendineae. 
     
     
         20 . The medical system of  claim 17 , wherein the valve repair device is configured to engage the heart wall and the underside of the at least one leaflet without penetrating the heart wall tissue or the leaflet.