Prosthetic cardiac valve devices, systems, and methods

Abstract

A system for treating a diseased native valve in a patient includes a valve prosthesis and a delivery device. The prosthesis includes an anchor and a frame. The delivery device includes an outer sheath, an inner shaft, an anchor guide, and a tether. The anchor is shaped to encircle chordae or leaflets of a native valve. The frame is configured to sit within the anchor. The inner shaft is positioned within the outer sheath and translatable and rotatable relative to the outer sheath. The anchor guide is attached to a distal end of the inner shaft and has a curved distal section. The tether is configured to detachably couple to the anchor and to longitudinally translate the anchor within the inner shaft and anchor guide. The anchor is configured to be actuated from a delivery configuration to the deployed configuration when the anchor is translated out of the anchor guide.

1 - 25 . (canceled) 
     
     
         26 . A delivery system for delivering a prosthesis to a diseased valve, the delivery system comprising:
 an outer sheath;   an inner shaft within the outer sheath, the inner shaft translatable and rotatable relative to the outer sheath; and   an anchor guide attached to a distal end of the inner shaft, the anchor guide comprising a proximal section that defines a central axis and a distal section that curves about the central axis in a tapered spiral.   
     
     
         27 . The delivery system of  claim 26 , wherein the tapered spiral of the distal section extends more than 360 degrees. 
     
     
         28 . The delivery system of  claim 26 , further comprising an anchor slidably disposed within the anchor guide. 
     
     
         29 . The delivery system of  claim 28 , wherein the anchor guide is configured to correctly orient the anchor relative to a longitudinal axis of the inner shaft in order to facilitate concentric wrapping of the anchor around the inner shaft as the anchor is deployed from the anchor guide. 
     
     
         30 . The delivery system of  claim 26 , wherein the outer sheath is steerable. 
     
     
         31 . The delivery system of  claim 26 , wherein the distal section transitions continuously from a high pitch, low radius curve at a proximal end to a low pitch, high radius curve at a distal end. 
     
     
         32 . The delivery system of  claim 26 , wherein a distal-most portion of the distal section resides in a plane that is orthogonal to the central axis. 
     
     
         33 . The delivery system of  claim 26 , wherein a curvature of the distal section is configured to match a curvature of an anchor of the prosthesis. 
     
     
         34 . The delivery system of  claim 26 , wherein the inner shaft and the anchor guide are of unitary construction. 
     
     
         35 . A delivery system for delivering a prosthesis to a diseased valve, the delivery system comprising:
 an outer sheath;   an inner shaft within the outer sheath, the inner shaft translatable and rotatable relative to the outer sheath; and   an anchor guide attached to a distal end of the inner shaft, the anchor guide comprising a proximal section that defines a central axis and a distal section that forms a tapered corkscrew and curves about the central axis, wherein the inner shaft and anchor guide are configured to rotate relative to the outer sheath.   
     
     
         36 . The delivery system of  claim 35 , wherein the distal section extends more than 360 degrees. 
     
     
         37 . The delivery system of  claim 35 , further comprising an anchor slidably disposed within the anchor guide. 
     
     
         38 . The delivery system of  claim 37 , wherein the anchor guide is configured to correctly orient the anchor of the prosthesis relative to the central axis in order to facilitate concentric wrapping of the anchor around the central axis as the anchor is deployed from the anchor guide. 
     
     
         39 . The delivery system of  claim 35 , wherein the outer sheath is steerable. 
     
     
         40 . The delivery system of  claim 35 , wherein the distal section transitions continuously from a high pitch, low radius curve at a proximal end to a low pitch, high radius curve at a distal end. 
     
     
         41 . The delivery system of  claim 35 , wherein a distal-most plane of the distal section is orthogonal to the central axis. 
     
     
         42 . The delivery system of  claim 35 , wherein a curvature of the distal section is configured to match a curvature of an anchor of the prosthesis. 
     
     
         43 . The delivery system of  claim 35 , wherein the inner shaft and the anchor guide are of unitary construction. 
     
     
         44 . A delivery system for delivering a prosthesis to a diseased valve, the delivery system comprising:
 an outer sheath;   an inner shaft within the outer sheath, the inner shaft translatable and rotatable relative to the outer sheath; and   an anchor guide attached to a distal end of the inner shaft, the anchor guide comprising a proximal section that defines a central axis, a distal section that curves about the central axis, and an intermediate section between the proximal section and the distal section, wherein the intermediate section transitions in a tapered spiral from a first radius of curvature to a second radius of curvature.   
     
     
         45 . The delivery system of  claim 44 , wherein the distal section extends more than 360 degrees. 
     
     
         46 . The delivery system of  claim 44 , wherein the distal section comprises the second radius of curvature. 
     
     
         47 . The delivery system of  claim 44 , wherein the distal section resides in a distal-most plane that is orthogonal to the central axis. 
     
     
         48 . The delivery system of  claim 44 , wherein the distal section has a relatively constant radius of curvature. 
     
     
         49 . The delivery system of  claim 44 , further comprising an anchor slidably disposed within the anchor guide. 
     
     
         50 . The delivery system of  claim 44 , wherein a curvature of the distal section is configured to match a curvature of an anchor of the prosthesis. 
     
     
         51 . The delivery system of  claim 44 , wherein the inner shaft and the anchor guide are of unitary construction. 
     
     
         52 . The delivery system of  claim 44 , wherein the distal section is concentric to the central axis of the proximal section. 
     
     
         53 . The delivery system of  claim 44 , wherein the second radius of curvature is larger than the first radius of curvature. 
     
     
         54 . The delivery system of  claim 32 , wherein the distal-most portion of the distal section extends at least 180 degrees.