Disclosed herein are systems and methods for a replacement heart-valve delivery system, comprising a replacement heart valve and a delivery component. The delivery component enables control of the replacement heart valve such that it can control collapsing and expanding the heart valve. Due to the nature of the flexible wire frame making up the heart valve, as well as its size, the delivery component allow for flexibility in the delivery catheter. The claimed invention thus allows for less traumatic delivery, more precise delivery, and a greater number of options on how to deliver.

Systems and methods are provided for repairing a heart valve, such as a mitral, tricuspid or aortic valve, using an adjustable and removable implant that can be delivered to the heart through the apex in a simplified and non-invasive manner. The implant can include a prosthetic valve portion coupled to a proximal end of a shaft, and an anchor portion coupled to a distal end of the shaft. The prosthetic valve can be suspended within an opening of the heart valve while the anchor portion is affixed to the apex of the heart. When the implant is deployed, a distance between the prosthetic valve portion and the anchor portion can be adjusted, and/or the implant or a portion thereof can be rotated to thereby change the position of the prosthetic valve within the heart valve. This can allow correcting for post-implantation movements of the implant to mitigate potential complications.

Disclosed herein are embodiments of a delivery system which can be used to recapture and/or reposition a replacement valve, such as a replacement mitral valve, after initial deployment of the valve. Embodiments of the disclosure can use the crimping/tensioning of sutures in order to re-crimp the replacement valve after release, though longitudinal or rotational forces.

A guide wire introduction device for positioning at least one guide wire around a heart valve. The device includes a first catheter provided with a distal deflection system, a second catheter inserted inside the first catheter, at least one lumen capable of causing a guide wire to slide therein and provided with a distal deflection system for deflecting the end thereof through an angle greater than 90°, and a third catheter inserted inside the first catheter. The third catheter has a guide wire capturing device therein and is provided with a distal deflection system.

Described is a delivery system for percutaneous delivery and implantation of a heart valve. The delivery system includes a handle with a sheath extending therefrom. A splay shaft extends from the handle through the sheath. At least two arms extend from the handle through the splay shaft. The at least two arms are operable for holding a heart valve. A sheath controller is housed within the handle and is operable for selectively advancing or retracting the sheath to constrain or expose a heart valve as attached with the at least two arms. A splay shaft controller is housed within the handle for allowing the user to selectively advance or retract the splay shaft to constrain or expose the at least two arms. Finally, a valve release is attached with the handle to allow a user to selectively release a heart valve as attached with the at least two arms.

A prosthetic heart valve includes a collapsible and expandable stent having an outflow end and an inflow end, a plurality of commissure features attached to the stent, a plurality of anchoring features disposed on legs of the stent, the plurality of anchoring features being coupleable to a delivery device for repositioning, and a valve assembly disposed within the stent. The anchoring features may be configured to attach to heart tissue to help secure the prosthetic heart valve in an operating position.

An expansion and locking mechanism for a prosthetic valve and associated methods are disclosed. As one example, an expansion and locking mechanism for an implantable prosthetic device can include a first member coupled to a frame of the device and including at least one extension member extending in a circumferential direction and having a free end biased radially inward, into an interior of the first member and a second member coupled to the frame at a second location spaced apart from the first location, the second member extending at least partially inside the first member and comprising a plurality of radial extensions spaced apart from one another along a portion of a length of the second member, the plurality of radial extensions arranged in a first side of the second member that is arranged opposite a second side of the second member, the second side not including any radial extensions.

Stented prosthetic heart valve crimping tools and methods, and transcatheter delivery systems for delivering a crimped prosthetic heart valve. Methods of the present disclosure include crimping or compressing a stented prosthetic heart valve via spherical compression to a spherically compressed shape, and then delivering the so-shaped prosthesis to a target site. Delivery systems carrying a spherically-compressed prosthesis have a reduced length profile as compared to conventional, elongated configurations, providing increased maneuverability and positioning.

Delivery devices for a stented prosthetic heart valve. The delivery device includes a spindle, at least one cord, and a lateral control feature. The cord is tensioned to crimp the prosthesis to a compressed condition for delivery to a target site. Tension is lessened to allow the prosthesis to self-expand. In a tethered and expanded state in which the prosthesis has self-expanded and is connected to the spindle by the cord, the lateral control feature directs the spindle to a prescribed location relative to the prosthesis appropriate for a functional evaluation of the prosthesis. In some embodiments, the spindle is directed to a center of the prosthesis; in other embodiments, the spindle is held at a commissure of the prosthesis. The lateral control features of the present disclosure assume numerous forms.

Delivery devices for a stented prosthetic heart valve. The delivery device includes a spindle, at least one cord, and a covering feature associated with the spindle for selectively covering at least a portion of a stented prosthetic heart valve tethered to the spindle in a delivery state. In some embodiments, the covering feature includes a tip mounted to the spindle. The tip can include an overhang region for selectively covering a portion of the stented prosthetic heart valve. In other embodiments, the tip can include a tip body and a compressible foam bumper. In yet other embodiments, the covering feature includes an outer sheath arranged to selectively cover the stented prosthetic heart valve. The outer sheath can be elastic and stretchable for recapturing a partially expanded prosthesis, for example by including one or more windows covered by a stretchable covering layer.