Paravalvular leak occlusion device for self-expanding heart valves

Abstract

A system for replacing native valve function includes a prosthetic heart valve having a collapsible and expandable stent, the stent having a plurality of sections, and a valve assembly disposed in the stent. The system further includes an occluder device having an expandable body having a first end and a second end, a fastener coupled to the first end of the body and to a portion of the stent at a first position adjacent a first section of the stent, and a disk coupled to the second end of the body and to a portion of the stent at a second position in a section other than the first section.

1 . (canceled) 
     
     
         2 . A system for replacing native valve function, the system comprising:
 a prosthetic heart valve having a collapsible and expandable stent, the stent having a plurality of sections, and a valve assembly disposed in the stent; and   an occluder device comprising an expandable body having a first end and a second end, a fastener coupled to the first end of the body and to a portion of the stent at a first position adjacent a first section of the stent, and a disk coupled to the second end of the body and to a portion of the stent at a second position in a section other than the first section.   
     
     
         3 . The system of  claim 2 , wherein the stent includes an annulus section, a transition section, and an aortic section. 
     
     
         4 . The system of  claim 2 , wherein the disk is expandable from a collapsed configuration to a relaxed configuration. 
     
     
         5 . The system of  claim 4 , wherein the stent includes a plurality of cells, and the disk, in the relaxed configuration, has a size larger than a size of at least some of the cells of the stent and incapable of passing therethrough. 
     
     
         6 . The system of  claim 2 , wherein the stent includes a plurality of struts and the fastener is coupled to at least one of the plurality of the struts. 
     
     
         7 . The system of  claim 2 , wherein the body includes at least one of a metallic mesh or a shape-memory material. 
     
     
         8 . The system of  claim 2 , wherein the body has an elliptical longitudinal cross-section. 
     
     
         9 . The system of  claim 2 , wherein the body includes a metal mesh and polyester fiber intertwined with the metal mesh. 
     
     
         10 . The system of  claim 2 , wherein the fastener includes a loop of wire. 
     
     
         11 . The system of  claim 2 , wherein the disk is expandable and includes at least one of a metallic mesh or a shape-memory material. 
     
     
         12 . The system of  claim 2 , further comprising:
 a connector attached to the disk for coupling to a delivery device.   
     
     
         13 . The system of  claim 2 , wherein the body includes multiple segments, each segment being capable of independent radial expansion from the other segments. 
     
     
         14 . The system of  claim 2 , further comprising:
 a delivery system including an outer sheath, an inner wire disposed within and translatable with respect to the outer sheath, and a connector attached to the inner wire, the connector being configured to couple the inner wire to the disk of the occluder device.   
     
     
         15 . The system of  claim 14 , wherein the outer sheath is adapted to house the occluder device in a contracted configuration, and the outer sheath is sized to pass through a cell of the expandable stent. 
     
     
         16 . A method for occluding a gap between a prosthetic heart valve and adjacent body tissue, the method comprising:
 delivering an occluder to the heart valve, the occluder including (i) an expandable body, (ii) a fastener coupled to one end of the body, and (iii) an expandable disk coupled to another end of the body;   coupling the fastener to one end of the prosthetic heart valve; and   coupling the expandable disk to the prosthetic heart valve at a position spaced from the one end.   
     
     
         17 . The method of  claim 16 , wherein the step of coupling the fastener includes positioning a loop around an apex of a cell at the one end of the prosthetic heart valve. 
     
     
         18 . The method of  claim 16 , wherein the step of coupling the disk includes disposing the disk on an outside of at least one cell of the stent such that the disk cannot pass therethrough. 
     
     
         19 . The method of  claim 16 , wherein delivering the occluder comprises disposing the occluder within a delivery system and advancing the delivery system to the heart valve. 
     
     
         20 . The method of  claim 19 , further comprising:
 coupling the expandable disk to an inner wire of the delivery system.   
     
     
         21 . The method of  claim 20 , further comprising:
 decoupling the expandable disk from the inner wire after coupling the expandable disk to the heart valve.