Heart valve prosthesis delivery

Abstract

The present disclosure relates to heart valve prostheses, delivery devices, actuation handles, and other improved devices and methods that facilitate delivery of a heart valve prosthesis to a defective native valve structure in a patient, such as the aortic valve.

What is claimed is: 
     
         1 . A method for delivering a prosthetic heart valve prosthesis to a native valve structure of a patient, the valve prosthesis comprising a valve frame and a valve anchor, the method comprising:
 introducing the valve prosthesis into the patient at an implantation site via a valve prosthesis delivery device, the device comprising a proximal sheath component and a distal carrier assembly, the proximal sheath component receiving at least a portion of the valve anchor in a proximal sheath lumen, and the distal carrier assembly comprising a distal enclosure and a proximal enclosure, the distal enclosure being configured to receive at least a distal portion of the valve frame;   proximally retracting the proximal sheath in a proximal direction to permit expansion of the valve anchor; and   expanding the distal carrier assembly to permit expansion of the valve frame.   
     
     
         2 . The method of  claim 1 , further comprising distally urging a base portion of the valve anchor into engagement with a native valve structure. 
     
     
         3 . The method of  claim 1 , further comprising proximally retracting the valve frame relative to the valve anchor to engage a link mechanism therebetween and restricting a range of movement of the valve frame relative to the valve anchor. 
     
     
         4 . The method of  claim 3 , further comprising distally advancing the valve frame. 
     
     
         5 . The method of  claim 1 , wherein the expanding comprises distally advancing the distal enclosure relative to the proximal enclosure to permit expansion of the distal portion of the valve frame. 
     
     
         6 . The method of  claim 1 , wherein the expanding comprises proximally retracting the proximal enclosure relative to the distal enclosure to permit expansion of a proximal portion of the valve frame. 
     
     
         7 . The method of  claim 1 , wherein the expanding comprises proximally retracting the distal enclosure relative to the proximal enclosure and distally advancing the proximal enclosure relative to the distal enclosure to move the distal carrier assembly to a retrieval configuration for retracting the valve prosthesis delivery device from the patient. 
     
     
         8 . The method of  claim 1 , further comprising extending a plunger mechanism at least partially proximally out of the distal enclosure toward the proximal enclosure, aligning an outer surface of the distal enclosure with an outer surface of the proximal enclosure. 
     
     
         9 . The method of  claim 1 , wherein the proximal enclosure comprises a proximal section having an outer diameter smaller than the proximal enclosure, and wherein when a valve anchor is loaded onto the delivery device, the valve anchor extends between the proximal section and the proximal sheath in a loaded configuration. 
     
     
         10 . The method of  claim 9 , wherein the proximal section tapers in a proximal direction. 
     
     
         11 . A method for delivering a prosthetic heart valve prosthesis to a native valve structure of a patient, the method comprising:
 introducing the valve prosthesis into the patient at an implantation site via a valve prosthesis delivery device, the valve prosthesis comprising a valve frame coupled to a valve anchor via a link mechanism, the valve prosthesis being carried by the delivery device;   permitting expansion of the valve anchor; and   with the valve anchor expanded, proximally retracting the valve frame within and relative to the valve anchor to proximally slide the link mechanism along the valve anchor toward an engagement region of the valve anchor for capturing the link mechanism in the engagement region for restricting a range of movement of the valve frame relative to the valve anchor.   
     
     
         12 . The method of  claim 10 , wherein the delivery device comprises a proximal sheath component and a distal carrier assembly, the proximal sheath component receiving at least a portion of the valve anchor in a proximal sheath lumen, and wherein the permitting expansion of the valve anchor comprises proximally retracting the proximal sheath in a proximal direction relative to the valve anchor to permit expansion of the valve anchor. 
     
     
         13 . The method of  claim 12 , the distal carrier assembly comprising a distal enclosure and a proximal enclosure. 
     
     
         14 . The method of  claim 12 , further comprising distally advancing the valve frame into the valve anchor. 
     
     
         15 . The method of  claim 12 , further comprising expanding the distal carrier assembly to permit expansion of the valve frame. 
     
     
         16 . The method of  claim 12 , wherein the distally advancing the valve frame into the valve anchor comprises distally advancing the valve frame until further distal movement of the valve frame relative to the valve anchor is restricted by the link mechanism. 
     
     
         17 . The method of  claim 12 , wherein the permitting expansion of the valve frame comprises proximally retracting a proximal enclosure of the distal carrier assembly to expose a proximal portion of the valve frame. 
     
     
         18 . The method of  claim 17 , wherein the permitting expansion of the valve frame further comprises permitting a plunger mechanism to proximally urge a distal portion of the valve frame out of a distal enclosure of the distal carrier assembly to facilitate release of the valve frame from the distal carrier assembly. 
     
     
         19 . The method of  claim 18 , wherein the distal carrier assembly comprises a distal lumen and the plunger mechanism has a plunger head and biasing means disposed within the distal lumen, the plunger head being biased in a proximal direction by the biasing means, and wherein the permitting expansion of the valve frame comprises permitting the plunger head to move proximally within the distal lumen and to exert a proximally oriented force on the valve frame to release the valve frame from the distal lumen. 
     
     
         20 . The method of  claim 18 , wherein after the valve frame has been released, the method further comprises distally advancing the proximal enclosure over a proximal conical portion of the plunger mechanism to align an outer surface of the proximal enclosure with an outer surface of the distal enclosure of the distal carrier assembly. 
     
     
         21 . The method of  claim 20 , wherein the distally advancing the proximal enclosure over a proximal conical portion comprises abutting a distal end of the proximal enclosure against a proximal end of the distal enclosure. 
     
     
         22 . The method of  claim 11 , further comprising distally advancing the valve frame to pull the valve anchor distally relative to the native valve structure. 
     
     
         23 . The method of  claim 11 , further comprising rotating the valve frame, to rotationally adjust a position of the valve anchor relative to the native valve structure. 
     
     
         24 . The method of  claim 11 , wherein the permitting expansion of the valve frame comprises proximally retracting a proximal sheath of a delivery device to permit expansion of a base portion of the valve anchor. 
     
     
         25 . The method of  claim 24 , wherein a peak portion of the valve anchor is coupled to a grasper mechanism of a delivery device, and wherein distally urging the base portion of the valve anchor comprises distally advancing the grasper mechanism to convey a distal force to the valve anchor. 
     
     
         26 . The method of  claim 24 , wherein a base portion of the valve anchor is coupled to a grasper mechanism of a delivery device, and wherein distally urging the base portion of the valve anchor comprises distally advancing the grasper mechanism to convey a distal force to the valve anchor.