Abstract: An implantable prosthetic device can include a frame that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration. The frame can have a first set of a plurality of struts extending in a first direction, and a second set of a plurality of struts extending in a second direction, and each strut of the first set of struts can be pivotably connected to at least one strut of the second set of struts. Each strut can be curved helically with respect to a first, longitudinal axis of the frame, and each strut can be curved with respect to a second axis that is perpendicular to the first, longitudinal axis of the frame.

Abstract: An assembly can comprise a radially expandable and compressible annular frame, at least one linear actuator assembly coupled to the frame and at least one locking mechanism coupled to the frame. The linear actuator can be configured to apply a distally directed force and/or a proximally directed force to the frame to radially expand or compress the frame. The locking mechanism can comprise a first sleeve member connected to the frame at a first location, a second sleeve member having internal threads and being connected to the frame at a second location, and a first screw configured to engage the internal threads of the second sleeve member to retain the frame in a radially expanded state.

Abstract: A prosthesis retaining assembly for securing an implantable prosthesis to a catheter assembly can include a first member including a prosthesis retaining slot configured to retain a portion of the prosthesis. The retaining slot can have a first portion with a first width and a second portion with a second width. The first portion can be distal to the second portion. The second width can be larger than the first width, and the retaining slot can have an opening at a first surface of the first member. The prosthesis retaining assembly can also include a second member configured to be move relative to the first member. The second member can be configured to move to a position that obstructs a portion of the opening of the retaining slot.

Abstract: A prosthesis retaining assembly for securing an implantable prosthesis to a catheter assembly can include a first member including a prosthesis retaining slot configured to retain a portion of the prosthesis. The retaining slot can have a first portion with a first width and a second portion with a second width. The first portion can be distal to the second portion. The second width can be larger than the first width, and the retaining slot can have an opening at a first surface of the first member. The prosthesis retaining assembly can also include a second member configured to be move relative to the first member. The second member can be configured to move to a position that obstructs a portion of the opening of the retaining slot.

Abstract: An assembly can comprise a radially expandable and compressible annular frame, at least one linear actuator assembly coupled to the frame and at least one locking mechanism coupled to the frame. The linear actuator can be configured to apply a distally directed force and/or a proximally directed force to the frame to radially expand or compress the frame. The locking mechanism can comprise a first sleeve member connected to the frame at a first location, a second sleeve member having internal threads and being connected to the frame at a second location, and a first screw configured to engage the internal threads of the second sleeve member to retain the frame in a radially expanded state.

Abstract: A medical device delivery system can include a dilator including a tip having a taper in a distal direction, a coupler, and a flap that radially protrudes from the tip. The flap can be configured to bend against a body lumen to cover at least a portion of the delivery system when the dilator is tracked through the body lumen. A medical device delivery system can include a dilator including a tip having a lumen and a coupler having a lumen. The coupler can be configured to securely connect to the tip such that the lumen of the tip is aligned with the lumen of the coupler to allow a guide wire to pass therethrough. Methods for loading a medical device into a delivery catheter are also disclosed.

Abstract: A valve retainer is connected to an elongate delivery member. The valve retainer is configured to releasably secure a prosthesis (e.g., a heart valve prosthesis) to the delivery member during delivery to a target site in a body (e.g., a native valve annulus). The valve retainer includes a rotational identifier that identifies the rotational orientation of the valve retainer when the valve retainer is positioned proximate to the target site. A heart valve prosthesis can include a commissural post that has a predetermined rotational position relative to the rotational identifier, such that the heart valve prosthesis can be rotationally aligned with the native commissures of the native valve by rotating the delivery member and the valve retainer until the commissural post is aligned with a native valve commissure and the rotational identifier is visible.

Abstract: A prosthesis retaining assembly for securing an implantable prosthesis to a catheter assembly can include a first member including a prosthesis retaining slot configured to retain a portion of the prosthesis. The retaining slot can have a first portion with a first width and a second portion with a second width. The first portion can be distal to the second portion. The second width can be larger than the first width, and the retaining slot can have an opening at a first surface of the first member. The prosthesis retaining assembly can also include a second member configured to be move relative to the first member. The second member can be configured to move to a position that obstructs a portion of the opening of the retaining slot.

Abstract: Catheter assemblies including a handle assembly located on the proximal end of the catheter assembly and a distal tip assembly located on the distal end of the catheter assembly. A crimping funnel is slidably positioned along the catheter. The crimping funnel includes a distal end having a first diameter and a proximal end having a second diameter smaller than the first diameter. An axial split is formed in the proximal end. A first collar is provided encompassing a portion of the proximal end. The first collar is configured to hold the axial split in the proximal end together when the first collar is at a first axial location along the proximal end, and to allow the axial split in the proximal end to open when the first collar is at a second axial location along the proximal end, such that the crimping funnel can be removed from the catheter assembly. Various methods of retaining a prosthetic valve on the catheter assembly during the crimping process are described.

Abstract: A prosthesis retaining assembly for securing an implantable prosthesis to a catheter assembly can include a first member including a prosthesis retaining slot configured to retain a portion of the prosthesis. The retaining slot can have a first portion with a first width and a second portion with a second width. The first portion can be distal to the second portion. The second width can be larger than the first width, and the retaining slot can have an opening at a first surface of the first member. The prosthesis retaining assembly can also include a second member configured to be move relative to the first member. The second member can be configured to move to a position that obstructs a portion of the opening of the retaining slot.

Abstract: A stented prosthetic heart valve including a stent, a plurality of leaflets, and a coupling apparatus. The stent includes a plurality of struts combining to define a generally tubular body, with the struts forming strut segments. The leaflets are mounted to the stent, and include a leaflet provided as part of a first leaflet layer that further forms a tab region. The coupling apparatus is configured for connecting the first leaflet layer to the stent, and includes a backing layer, a guide plate, and a pin. The guide plate and the pin are formed apart from the stent. In this regard, a portion of the backing layer and the tab region are secured between the guide plate and the pin. Further, another portion of the backing layer is attached to at least one of the strut segments to mount the leaflet of the first leaflet layer to the stent.

Abstract: A stented prosthetic heart valve including a stent, a plurality of leaflets, and a coupling apparatus. The stent includes a plurality of struts combining to define a generally tubular body, with the struts forming strut segments. The leaflets are mounted to the stent, and include a leaflet provided as part of a first leaflet layer that further forms a tab region. The coupling apparatus is configured for connecting the first leaflet layer to the stent, and includes a backing layer, a guide plate, and a pin. The guide plate and the pin are formed apart from the stent. In this regard, a portion of the backing layer and the tab region are secured between the guide plate and the pin. Further, another portion of the backing layer is attached to at least one of the strut segments to mount the leaflet of the first leaflet layer to the stent.

Abstract: A medical device delivery system can include a dilator including a tip having a taper in a distal direction, a coupler, and a flap that radially protrudes from the tip. The flap can be configured to bend against a body lumen to cover at least a portion of the delivery system when the dilator is tracked through the body lumen. A medical device delivery system can include a dilator including a tip having a lumen and a coupler having a lumen. The coupler can be configured to securely connect to the tip such that the lumen of the tip is aligned with the lumen of the coupler to allow a guide wire to pass therethrough. Methods for loading a medical device into a delivery catheter are also disclosed.

Abstract: A valve retainer is connected to an elongate delivery member. The valve retainer is configured to releasably secure a prosthesis (e.g., a heart valve prosthesis) to the delivery member during delivery to a target site in a body (e.g., a native valve annulus). The valve retainer includes a rotational identifier that identifies the rotational orientation of the valve retainer when the valve retainer is positioned proximate to the target site. A heart valve prosthesis can include a commissural post that has a predetermined rotational position relative to the rotational identifier, such that the heart valve prosthesis can be rotationally aligned with the native commissures of the native valve by rotating the delivery member and the valve retainer until the commissural post is aligned with a native valve commissure and the rotational identifier is visible.

Abstract: A prosthesis retaining assembly for securing an implantable prosthesis to a catheter assembly can include a first member including a prosthesis retaining slot configured to retain a portion of the prosthesis. The retaining slot can have a first portion with a first width and a second portion with a second width. The first portion can be distal to the second portion. The second width can be larger than the first width, and the retaining slot can have an opening at a first surface of the first member. The prosthesis retaining assembly can also include a second member configured to be move relative to the first member. The second member can be configured to move to a position that obstructs a portion of the opening of the retaining slot.

Abstract: Catheter assemblies including a handle assembly located on the proximal end of the catheter assembly and a distal tip assembly located on the distal end of the catheter assembly. A crimping funnel is slidably positioned along the catheter. The crimping funnel includes a distal end having a first diameter and a proximal end having a second diameter smaller than the first diameter. An axial split is formed in the proximal end. A first collar is provided encompassing a portion of the proximal end. The first collar is configured to hold the axial split in the proximal end together when the first collar is at a first axial location along the proximal end, and to allow the axial split in the proximal end to open when the first collar is at a second axial location along the proximal end, such that the crimping funnel can be removed from the catheter assembly. Various methods of retaining a prosthetic valve on the catheter assembly during the crimping process are described.