A delivery system for delivering a heart valve prosthesis includes a heart valve prosthesis and a delivery catheter. The heart valve prosthesis includes an anchoring member and an inner valve support, and further includes a radially collapsed configuration and a radially expanded configuration. The delivery catheter includes a handle, an outer shaft, an intermediate shaft, an inner shaft, and a distal tip component. The delivery catheter further includes a delivery configuration. In the delivery configuration, the outer shaft of the delivery catheter is configured to retain a first portion of the anchoring member, the intermediate shaft is configured to retain a first portion of the inner valve support, and the distal tip component is configured to retain a second end of the anchoring member and a second end of the inner valve support each in a radially compressed state.

Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve assembly. In embodiments, a prosthetic heart valve assembly, including a self-expandable support structure and a self-expanding heart valve, are advanced through the aortic arch of a patient using a delivery system. The support structure, which includes a plurality leaflet retaining arms, is at least partially expanded and positioned on or adjacent to the outflow side of the aortic valve. The prosthetic heart valve is positioned in the aortic valve. The prosthetic heart valve is expanded while it is within an interior of the support structure and while the support structure is positioned on or adjacent to the outflow side of the aortic valve, thereby causing one or more native leaflets of the aortic valve to be frictionally secured between the arms of the support structure and the expanded prosthetic heart valve.

A method is provided for implanting a valve having at least one valve leaflet within the cardiovascular system of a subject. One step of the method includes preparing a substantially dehydrated bioprosthetic valve and then providing an expandable support member having oppositely disposed first and second ends and a main body portion extending between the ends. Next, the substantially dehydrated bioprosthetic valve is attached to the expandable support member so that the substantially dehydrated bioprosthetic valve is operably secured within the main body portion of the expandable support member. The expandable support member is then crimped into a compressed configuration and placed at a desired location within the cardiovascular system of the subject. Either before or after placement at the desired location, fluid or blood re-hydrates the substantially dehydrated bioprosthetic valve.

A system including a self-expanding prosthesis configured to foreshorten during deployment thereof and a delivery device configured to percutaneously deliver the self-expanding prosthesis. The delivery device includes a handle having an actuator thereon, an outer sheath including a proximal end coupled to the handle and a pusher shaft slidingly disposed within the outer sheath. The pusher shaft has a proximal end coupled to the handle and a distal end configured to releasably couple to the self-expanding prosthesis such that the self-expanding prosthesis axially moves therewith. The inner shaft has a distal portion of the inner shaft that is configured to receive a self-expanding prosthesis thereon. The outer sheath and the pusher shaft are configured to simultaneously move in opposing axial directions via actuation of the actuator on the handle to compensate for the foreshortening of the self-expanding prosthesis during deployment.

A catheter device for transporting an implant to a target location in a body lumen and also for releasing the implant at the target location. The device includes an outer shaft configured to transport the implant to the target location, and an implant capsule configured to receive the implant. The implant capsule has a tubular capsule core, which surrounds the implant prior to the release. The capsule core, at a proximal end of the capsule core, has a plurality of tabs for fixing the capsule core to the outer shaft, which tabs protrude from a tubular portion of the capsule core along an axial direction of the capsule core.

A delivery system includes a handle, an inner shaft having a distal portion configured to receive the heart valve prosthesis thereon, a push wire slidingly disposed through a lumen of the inner shaft, and an outer sheath configured to cover the heart valve prosthesis during delivery. A split distal tip or nosecone is attached to a distal end of the inner shaft and includes at least one cutout portion formed through a sidewall thereof. A proximal end of the push wire is operatively coupled to an actuator of the handle and a distal end of the push wire is attached to the cutout portion of the nosecone. When the nosecone is in a delivery configuration the cutout portion is substantially flush with the sidewall of the nosecone. When the nosecone is in a deployed configuration the cutout portion is spaced apart from the sidewall of the nosecone.

Methods and systems for rotationally aligning a commissure of a prosthetic heart valve with a commissure of a native valve are disclosed. In some examples, a delivery apparatus can include a first shaft configured to rotate around a central longitudinal axis of the delivery apparatus, a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end portion of the first shaft, an inflatable balloon coupled to the distal end portion of the first shaft, and a third shaft surrounding the first shaft. The first shaft is configured to rotate within the third shaft and translate axially relative to the third shaft, and the third shaft includes a distal tip portion including a plurality of internal helical expansion grooves and a plurality of external helical expansion grooves that are configured to allow the distal tip portion to flex radially outward.

Embodiments of a delivery apparatus for implanting a prosthetic valve are disclosed. The delivery apparatus can include a handle, a first shaft extending from a distal end of the handle, a second shaft extending through a lumen of the first shaft and the handle, and a gripper located proximal to a proximal end of the handle. A proximal end of the second shaft can be connected to the gripper, and the gripper can be axially moveable relative to the handle such that axial movement of the gripper causes corresponding axial movement of the second shaft relative to the first shaft. The gripper can have a bottom surface that is substantially coplanar with a bottom surface of the handle.

A delivery assembly includes a prosthetic device, a catheter shaft, a release wire, a first line, and a second line. The prosthetic device has a first arm and a second arm. The release wire extends through the catheter shaft. The first line includes a first loop. The first line extends from the catheter shaft, through the first arm of the prosthetic device, and to the release wire, where the release wire extends through the first loop. The second line includes a second loop. The second line extends from the catheter shaft, through the second arm of the prosthetic device, and to the release wire, where the release wire extends through the second loop.

An implant includes a primary structural element, and two clips coupled to the primary structural element, on opposite lateral sides of the primary structural element from each other, each of the clips having a first clip element and a second clip element. The implant is transluminally advanced to a heart valve of a subject. The implant is coupled to leaflets of the valve (i) by, for each of the clips, closing the clip around a central part of a respective leaflet of the valve by causing deflection between the first clip element and the second clip element, thereby sandwiching the central part of the respective leaflet between the first clip element and the second clip element, and (ii) such that the leaflets form a double orifice configuration, with the primary structural element disposed between the central parts of the leaflets. Other embodiments are also described.