Abstract: A delivery apparatus for a prosthetic heart valve includes a shaft, an inner balloon, and an outer balloon. The shaft has a lumen extending from a proximal end portion to a distal end portion and a plurality of openings formed in the distal end portion. The shaft is configured such that a fluid can flow through the lumen and the openings. The inner balloon has end portions and a center portion disposed between the end portions. The inner balloon is mounted on the distal end portion of the shaft and is in fluid communication with the openings of the shaft. When the inner balloon is inflated with the fluid, the end portions expand farther radially outwardly than the center portion. The outer balloon is mounted to the shaft and disposed over the inner balloon. The outer balloon is configured to fully expand after the inner balloon at least partially expands.

Abstract: Embodiments of the present disclosure provide a delivery apparatus for a prosthetic heart valve. Disclosed steerable catheters can include a handle, a steerable shaft extending from the handle, and a pull wire. The shaft can include a main lumen, an inner polymeric layer surrounding the main lumen, a braided layer surrounding the inner polymeric layer, and an outer polymeric layer surrounding the braided layer, the outer polymeric layer defining a pull wire lumen. The pull wire can extend from the handle and through the pull wire lumen and can have a distal end portion coupled to a distal end portion of the shaft.

Abstract: Embodiments of the present disclosure provide a delivery apparatus for a prosthetic heart valve. Disclosed delivery apparatuses can include a handle, a first shaft extending from the handle, a second shaft disposed around the first shaft, and a valve cover. The valve cover can be coupled to a distal end portion of the first shaft and can be configured to house a prosthetic heart valve in a radially compressed state. The valve cover can have an outer diameter greater than an outer diameter of the second shaft, and the first shaft and valve cover can be movable together in an axial direction relative to the second shaft.

Abstract: In one representative embodiment, a steerable catheter device comprises a shaft comprising a proximal portion, a distal portion, and a pull-wire lumen that extends at least partially through the proximal and distal portions. A pull wire extends through the pull-wire lumen and has a proximal end portion and a distal end portion, wherein the distal end portion of pull wire is fixed to the distal end portion of the shaft. An adjustment mechanism is operatively connected to the proximal end portion of the pull wire and configured to increase and decrease tension in the pull wire to adjust the curvature of the distal portion of the shaft. An axially non-compressible pull-wire sleeve extends co-axially through the pull-wire lumen and over the pull wire.

Abstract: A method of delivery a prosthetic heart valve includes inserting a delivery apparatus and a prosthetic heart valve into a patient's vasculature. The delivery apparatus includes a steerable guide catheter, a balloon catheter, and a flex indicator. The balloon catheter extends coaxially through the guide catheter, the prosthetic heart valve is mounted on a distal end portion of the balloon catheter, and the flex indicator is movably coupled to a handle of the guide catheter. The method further includes adjusting flexion of a steerable section of the guide catheter to position the prosthetic heart valve. The flex indicator moves relative to the handle of the guide catheter as the flexion of the steerable section is adjusted, and the handle comprises one or more visual indicators adjacent the flex indicator to provide visual indication of an amount of flexion of the steerable section of the guide catheter.

Abstract: An apparatus for delivering a prosthetic heart valve includes a steerable guide catheter, a balloon catheter, and a flex indicator. The guide catheter has a handle and a guide tube extending from the handle. The guide tube has a distal end portion comprising a steerable section. The guide catheter further includes an adjustment mechanism on the handle and a pull wire connecting the adjustment mechanism to the steerable section for changing flexion of the steerable section. The balloon catheter includes a shaft extending coaxially through the guide tube. The shaft includes a proximal end portion and a distal end portion. The balloon catheter further includes a balloon mounted on the distal end portion of the shaft. The flex indicator moves relative to the handle upon adjustment of the adjustment mechanism. The handle includes visual indicia adjacent the flex indicator to provide visual indication of the flexion of the steerable section.

Abstract: A heart valve delivery apparatus includes a valve carrying member. A prosthetic valve is crimped onto the valve carrying member at a location that is distal or proximal to the balloon member, thereby providing a smaller profile delivery apparatus.

Abstract: A method of delivery a prosthetic heart valve includes inserting a delivery apparatus and a prosthetic heart valve into a patient's vasculature. The delivery apparatus includes a steerable guide catheter, a balloon catheter, and a flex indicator. The balloon catheter extends coaxially through the guide catheter, the prosthetic heart valve is mounted on a distal end portion of the balloon catheter, and the flex indicator is movably coupled to a handle of the guide catheter. The method further includes adjusting flexion of a steerable section of the guide catheter to position the prosthetic heart valve. The flex indicator moves relative to the handle of the guide catheter as the flexion of the steerable section is adjusted, and the handle comprises one or more visual indicators adjacent the flex indicator to provide visual indication of an amount of flexion of the steerable section of the guide catheter.

Abstract: An assembly includes a prosthetic heart valve and a delivery apparatus for implanting the prosthetic heart valve within the native aortic valve of a patient. The prosthetic heart valve has a radially compressible and expandable metallic stent and a flexible valvular structure mounted within the stent. The delivery apparatus has a handle, a first shaft having a proximal end portion and a distal end portion, a second shaft extending co-axially through the first shaft and having a proximal end portion and a distal end portion, the proximal end portions of the first and second shafts extending distally from the handle, a valve cover coupled to the distal end portion of the first shaft, and a nose piece coupled to the distal end portion of the second shaft.

Abstract: Embodiments of the present disclosure provide an introducer device for introducing a medical device into a patient's vasculature. In one embodiment, the introducer device comprises a housing, a distal sheath adapted to be inserted into a patient's vasculature with the housing positioned outside of the patient's vasculature, a hemostatic seal mounted within the housing, and a tube positioned within the housing and movable longitudinally relative to the hemostatic seal between a proximal position and a distal position. In the proximal position, a distal end of the tube is positioned proximal to the hemostatic seal with the hemostatic seal closed. In the distal position, the distal end of the tube extends through the hemostatic seal and permits the medical device to be inserted through the housing and into the patient's vasculature without contacting the hemostatic seal.

Abstract: A method of delivery a prosthetic heart valve includes inserting a delivery apparatus and a prosthetic heart valve into a patient's vasculature. The delivery apparatus includes a steerable guide catheter, a balloon catheter, and a flex indicator. The balloon catheter extends coaxially through the guide catheter, the prosthetic heart valve is mounted on a distal end portion of the balloon catheter, and the flex indicator is movably coupled to a handle of the guide catheter. The method further includes adjusting flexion of a steerable section of the guide catheter to position the prosthetic heart valve. The flex indicator moves relative to the handle of the guide catheter as the flexion of the steerable section is adjusted, and the handle comprises one or more visual indicators adjacent the flex indicator to provide visual indication of an amount of flexion of the steerable section of the guide catheter.

Abstract: An apparatus for delivering a prosthetic heart valve includes a steerable guide catheter, a balloon catheter, and a flex indicator. The guide catheter has a handle and a guide tube extending from the handle. The guide tube has a distal end portion comprising a steerable section. The guide catheter further includes an adjustment mechanism on the handle and a pull wire connecting the adjustment mechanism to the steerable section for changing flexion of the steerable section. The balloon catheter includes a shaft extending coaxially through the guide tube. The shaft includes a proximal end portion and a distal end portion. The balloon catheter further includes a balloon mounted on the distal end portion of the shaft. The flex indicator moves relative to the handle upon adjustment of the adjustment mechanism. The handle includes visual indicia adjacent the flex indicator to provide visual indication of the flexion of the steerable section.

Abstract: Embodiments of the present disclosure provide a delivery apparatus for delivering a prosthetic heart valve to a native valve site via the human vasculature without the need for a separate introducer sheath. The delivery apparatus is particularly well-suited for advancing a prosthetic valve through the aorta (i.e., in a retrograde approach) for replacing a stenotic aortic valve.

Abstract: In one representative embodiment, a steerable catheter device comprises a shaft comprising a proximal portion, a distal portion, and a pull-wire lumen that extends at least partially through the proximal and distal portions. A pull wire extends through the pull-wire lumen and has a proximal end portion and a distal end portion, wherein the distal end portion of pull wire is fixed to the distal end portion of the shaft. An adjustment mechanism is operatively connected to the proximal end portion of the pull wire and configured to increase and decrease tension in the pull wire to adjust the curvature of the distal portion of the shaft. An axially non-compressible pull-wire sleeve extends co-axially through the pull-wire lumen and over the pull wire.

Abstract: An assembly includes a prosthetic heart valve and a delivery apparatus for implanting the prosthetic heart valve within the native aortic valve of a patient. The prosthetic heart valve has a radially compressible and expandable metallic stent and a flexible valvular structure mounted within the stent. The delivery apparatus has a handle, a first shaft having a proximal end portion and a distal end portion, a second shaft extending co-axially through the first shaft and having a proximal end portion and a distal end portion, the proximal end portions of the first and second shafts extending distally from the handle, a valve cover coupled to the distal end portion of the first shaft, and a nose piece coupled to the distal end portion of the second shaft.

Abstract: In one representative embodiment, a steerable catheter device comprises a shaft comprising a proximal portion, a distal portion, and a pull-wire lumen that extends at least partially through the proximal and distal portions. A pull wire extends through the pull-wire lumen and has a proximal end portion and a distal end portion, wherein the distal end portion of pull wire is fixed to the distal end portion of the shaft. An adjustment mechanism is operatively connected to the proximal end portion of the pull wire and configured to increase and decrease tension in the pull wire to adjust the curvature of the distal portion of the shaft. An axially non-compressible pull-wire sleeve extends co-axially through the pull-wire lumen and over the pull wire.

Abstract: A delivery apparatus for a prosthetic heart valve includes a shaft, an inner balloon, and an outer balloon. The shaft has a lumen extending from a proximal end portion to a distal end portion and a plurality of openings formed in the distal end portion. The shaft is configured such that a fluid can flow through the lumen and the openings. The inner balloon has end portions and a center portion disposed between the end portions. The inner balloon is mounted on the distal end portion of the shaft and is in fluid communication with the openings of the shaft. When the inner balloon is inflated with the fluid, the end portions expand farther radially outwardly than the center portion. The outer balloon is mounted to the shaft and disposed over the inner balloon. The outer balloon is configured to fully expand after the inner balloon at least partially expands.

Abstract: Described herein are systems and methods from delivering prosthetic devices, such as prosthetic heart valves, through the body and into the heart for implantation therein. The prosthetic devices delivered with the delivery systems disclosed herein are, for example, radially expandable from a radially compressed state mounted on the delivery system to a radially expanded state for implantation using an inflatable balloon of the delivery system. Exemplary delivery routes through the body and into the heart include transfemoral routes, transapical routes, and transaortic routes, among others.

Abstract: Described herein are systems and methods from delivering prosthetic devices, such as prosthetic heart valves, through the body and into the heart for implantation therein. The prosthetic devices delivered with the delivery systems disclosed herein are, for example, radially expandable from a radially compressed state mounted on the delivery system to a radially expanded state for implantation using an inflatable balloon of the delivery system. Exemplary delivery routes through the body and into the heart include transfemoral routes, transapical routes, and transaortic routes, among others.

Abstract: Embodiments of the present disclosure provide a delivery apparatus for delivering a prosthetic heart valve to a native valve site via the human vasculature without the need for a separate introducer sheath. The delivery apparatus is particularly well-suited for advancing a prosthetic valve through the aorta (i.e., in a retrograde approach) for replacing a stenotic aortic valve.