Prosthetic heart valve and delivery apparatus

A delivery apparatus, comprising:

• an expandable prosthetic heart valve comprising a frame and a valve member having a plurality of flexible leaflets;
• a handle portion;
• a sheath configured to extend over and retain a self-expandable prosthetic heart valve in a compressed state;
• a shaft having a proximal end portion and a distal end portion, wherein the proximal end portion of the shaft is coupled to the handle portion;
• a tubular member positioned radially outside the shaft;
• at least one suture member secured to and extending from the tubular member proximate the distal end portion of the shaft and forming a loop;
• and
• a release wire radially outside of the shaft that extends through and is movable axially within a lumen of the tubular member;
• wherein the at least one suture member can extend through a portion of the prosthetic heart valve, wherein a spacer is positioned radially outside the shaft, and wherein a portion of the release wire is axially movable from a first position to a second position, wherein as viewed in a proximal to distal direction, the portion of the release wire extending from the tubular member, through the loop of the at least one suture member, and then through the spacer in the first position to releasably secure the suture member relative to the prosthetic heart valve, and the portion of the release wire withdrawn from the spacer and the loop of the at least one suture member in the second position, thereby releasing the suture member from the prosthetic heart valve.

A system for replacing a native heart valve, comprising:

• a prosthetic heart valve self-expandable from a low-profile collapsed configuration to an expanded configuration, wherein the prosthetic heart valve comprises a frame and a valve member having a plurality of flexible leaflets configured for allowing blood flow in only one direction, wherein the valve member is mounted to the frame;
• and
• a delivery apparatus comprising:
• a handle portion;
• a sheath sized to extend over and retain the prosthetic heart valve in a compressed state;
• a shaft having a proximal end portion and a distal end portion, wherein the proximal end portion of the shaft is coupled to the handle portion and the distal end portion is coupled to a nose piece that includes a gradual taper from a larger diameter to a smaller diameter;
• a tube positioned radially outside the shaft proximate the distal end portion of the shaft;
• at least one suture member secured to and extending from the tube and comprising a loop;
• and
• a release wire radially outside of the shaft that extends through and is movable axially within a lumen of the tube;
• wherein the release wire is axially movable from a first position to a second position, wherein, in the first position, the release wire extends through the lumen of the tube, then extends through the loop of the at least one suture member, as viewed in a proximal to distal direction, the at least one suture member extending through a proximal end portion of the frame of the prosthetic heart valve, and then extends through a spacer, and wherein, in the second position, the release wire is withdrawn from the spacer and the loop of the at least one suture member, thereby releasing the suture member from the prosthetic heart valve.