Prosthetic heart valve delivery systems and methods

Abstract

Methods of transcatheter delivery of a prosthetic heart valve. A distal region of a guide member assembly is advanced into a heart of a patient. The distal region is docked to native anatomy of the heart. A delivery device, including a collapsed prosthetic heart valve, is advanced over the docked guide member assembly. The collapsed prosthetic heart valve is located at an implantation site. The prosthetic heart valve is deployed from the delivery device, and then the delivery device is removed from the patient. At least a portion of the guide member assembly is removed from the patient. In some embodiments, the docking structure is docked to one or more of native mitral valve leaflets, chordae in the left ventricle, or walls of the left ventricle as part of a transseptal mitral valve delivery procedure.

What is claimed is: 
     
         1 . A system for treating a defective heart valve, the system comprising:
 a prosthetic heart valve expandable from a collapsed condition to an expanded condition;   a delivery device including:
 a delivery sheath assembly including a capsule, 
 a support shaft assembly disposed within the delivery sheath assembly and defining a central lumen, 
 wherein the delivery device is configured to maintain the prosthetic heart valve in the delivery condition between the capsule and the support shaft assembly, and is further configured to release the prosthetic heart valve with retraction of the capsule from over the prosthetic heart valve; and 
   a guide member assembly including:
 an elongated member sized to be slidably received within the central lumen, 
 a docking structure connected to a distal region of the elongated member, wherein the docking structure is configured to transition between a delivery arrangement and a deployed arrangement, and further wherein the docking structure is configured to dock with native anatomy in the deployed arrangement; 
   wherein the guide member assembly is associated with the delivery device such that upon docking of the docking structure to native anatomy, the elongated member can be tensioned with advancement of the delivery device.   
     
     
         2 . The system of  claim 1 , wherein the docking structure is releasably connected to the elongated member. 
     
     
         3 . The system of  claim 2 , wherein the docking structure is threadably connected to the elongated member. 
     
     
         4 . The system of  claim 1 , wherein the docking structure is affixed to the elongated member. 
     
     
         5 . The system of  claim 1 , wherein the docking structure includes at least one anchor member selected from the group consisting of a clip, a hook, a screw, a barb, and a pincer. 
     
     
         6 . The system of  claim 1 , wherein the docking structure includes first and second anchor arms configured such that in the deployed arrangement, the first and second anchor arms span a heart chamber. 
     
     
         7 . The system of  claim 1 , wherein the guide member assembly further includes an outer sheath slidably receiving the elongated member and the docking structure, and further wherein the delivery arrangement includes the docking structure arranged in a collapsed condition within the outer sheath. 
     
     
         8 . The system of  claim 7 , wherein the docking structure is configured to self-deploy from the collapsed condition to the deployed arrangement upon release from the outer sheath. 
     
     
         9 . The system of  claim 1 , wherein the elongated member is a first elongated member and the docking structure is a first docking structure connected to the first elongated member, and wherein the guide member assembly further includes a second elongated member connected to a second docking structure, and a third elongated member connected to a third docking structure. 
     
     
         10 . The system of  claim 9 , wherein the guide member assembly further includes an outer sheath slidably receiving the first, second and third elongated members and the first-third docking structures. 
     
     
         11 . The system of  claim 10 , wherein the guide member assembly is configured such that when extended distal a distal end of the outer sheath, the first, second, and third elongated members can be manipulated independent of one another. 
     
     
         12 . The system of  claim 1 , wherein the elongated member and the docking structure are formed of an electrically conductive material, and wherein the system further includes an energy source electrically connected to the elongated member. 
     
     
         13 . The system of  claim 1 , wherein the docking structure includes an inflatable balloon. 
     
     
         14 . The system of  claim 13 , wherein the guide member assembly further includes a plurality of gripping bodies disposed on an exterior surface of the balloon. 
     
     
         15 . The system of  claim 14 , wherein each of the gripping bodies includes a base attached to the balloon and a tip opposite the base, and further wherein a direction of extension from the base to the tip includes a proximal component. 
     
     
         16 . The system of  claim 1 , wherein the docking structure includes a basket body. 
     
     
         17 . The system of  claim 1 , wherein the delivery device comprises the guide member assembly, and the docking structure is configured to provide a nose cone of the delivery device in the delivery arrangement. 
     
     
         18 . The system of  claim 17 , wherein the system is configured to provide a delivery state in which the docking structure is in the delivery arrangement and abuts a distal end of the delivery sheath assembly. 
     
     
         19 . The system of  claim 18 , wherein the delivery state includes the docking structure extending distal the distal end of the delivery sheath assembly. 
     
     
         20 . The system of  claim 1 , wherein the elongated member is selected from the group consisting of a wire and a suture.