A guiding device is provided. An implantable apparatus includes a member to be anchored. A position-limiting wire is detachably connected to the implantable apparatus. A proximal end of the position-limiting wire is connected to the control handle. A distal end of the guiding catheter is provided with a guiding member. A distal end portion of the guiding catheter is bendable. A proximal end of the delivery catheter and a proximal end of the guiding catheter are respectively connected to the control handle. When the control handle is manipulated to make the guiding member on the guiding catheter move along the position-limiting wire toward the distal end, the distal end portion of the guiding catheter is bent and deformed, such that the distal end of the guiding catheter abuts against the member to be anchored of the implantable apparatus.

A delivery apparatus for an expandable, implantable medical device comprises a handle portion, a shaft extending from the handle portion, a delivery capsule configured to house the medical device in a radially compressed state, and a rotatable component disposed in the handle portion and operatively coupled to the delivery capsule to produce axial movement of the delivery capsule upon rotation of the rotatable component. The delivery apparatus further comprises a motor disposed in the handle portion that is operatively coupled to the rotatable component so as to produce rotation of the rotatable component and corresponding axial movement of the delivery capsule. Further, the delivery apparatus comprises a manual deployment tool that is also configured to produce rotation of the rotatable component and corresponding axial movement of the delivery capsule when a manual pulling force is applied to the pull cord to pull the pull cord relative to the rotatable component.

A delivery apparatus for implanting a prosthetic heart valve includes one or more shafts and a handle coupled to the one or more shafts. The handle comprises one or more knobs, one or more adjustment mechanisms, and/or one or more control mechanisms. The knobs are configured for actuating the one or more adjustment mechanisms and/or the one or more control mechanisms. The one or more adjustment mechanisms are configured for moving the shafts relative to each other and/or relative to the handle. The one or more control mechanisms are configured for limiting the direction of movement and/or force applied to the one or more shafts.

A delivery system includes a catheter with a removable constraint. The removable constraint is a knit tubular construct. The removable constraint can be used, for example, to constrain a medical device to a delivery configuration. The removable constraint may include one or more fibers or strands arranged about the device to maintain the device in a constrained or delivery configuration.

A prosthetic heart valve comprises an annular frame comprising a plurality of interconnected struts, wherein the frame is radially compressible and expandable between a radially compressed state and a radially expanded state. A plurality of leaflets are situated within the frame, each leaflet comprising a main body, two opposing commissure tabs arranged on opposite sides of the main body and two opposing sub-commissure tabs arranged on opposite sides of the main body. Each commissure tab of a leaflet is paired with an adjacent commissure tab of an adjacent leaflet to form a commissure that is coupled to the frame. Each sub-commissure tab is paired with an adjacent sub-commissure tab of an adjacent leaflet and connected thereto, wherein each pair of sub-commissure tabs extends radially inwardly relative to the frame.

Apparatus includes a delivery tool and a prosthetic valve, the prosthetic valve includes a first frame, and a second frame coupled to the first frame. The delivery tool includes a first catheter, a second catheter, and a rod. A steerable portion of the second catheter extends out of the first catheter, and a steerable distal portion of the rod extends out of the second catheter. An extracorporeal rod-controller is operably coupled to the rod such that operating the extracorporeal rod-controller steers the steerable distal portion of the rod. In a delivery state of the apparatus, the prosthetic valve is compressed onto the rod, distal to the distal end of the second catheter, and the apparatus is transfemorally and transseptally advanceable into a left atrium of a heart of a subject. Other embodiments are also described.

Apparatus and methods are described herein for various embodiments of a prosthetic heart valve, delivery apparatus and delivery methods for delivering a prosthetic heart valve to a heart of a patient via a transapical or transvascular delivery approach. In some embodiments, a prosthetic heart valve includes an outer frame coupled to an inner frame and the outer frame is movable between a first configuration relative to the inner frame and a second inverted configuration relative to the inner frame. The valve can be delivered to a heart using an apparatus that includes a delivery sheath that defines a lumen that can receive the prosthetic heart valve therein when the outer frame is in the inverted configuration. Actuation wires are releasably coupled to the outer frame and can be used to help revert the outer frame after the valve is deployed outside of the delivery sheath and within the heart.

A gimbal handle assembly including: an inner gimbal and an outer gimbal that are concentrically linked and have pivot axes that are orthogonal relative to each other, a spool coupled to and rotatable around the outer gimbal, and a plurality of draw lines attached to the spool in a circumferential configuration, wherein rotation of the spool and/or rotation of the spool and the outer and inner gimbals increases or reduces tension in the draw lines. Also disclosed are a transcatheter valve delivery assembly that includes the gimbal handle assembly, a multi-lumen catheter, a sleeve attached to a distal end of the multi-lumen catheter, and a transcatheter heart valve including an expandable valve frame. Methods of delivering the transcatheter valve to a subject are described, wherein pitch and yaw orientations of the transcatheter valve can be precisely controlled with enhanced degrees of freedom.

A system for heart valve repair includes a packaging assembly for storing the replacement heart valve. The packaging assembly includes a valve support having a base for holding the replacement heart valve, a ring positioned within the valve support and configured to fit around a circumference of the replacement heart valve, and a retention mechanism. The retention mechanism includes a cap and plurality of sutures configured to be attached to the cap and to the replacement heart. The packaging assembly having a locked configuration in which the ring and the valve support are locked together and the sutures tension the replacement heart valve. The packaging assembly is designed to hold and transport a replacement heart valve and fits within a shipment jar.

Apparatus for endovascularly replacing a patient's heart valve, including: a replacement valve adapted to be delivered endovascularly to a vicinity of the heart valve; an expandable anchor adapted to be delivered endovascularly to the vicinity of the heart valve; and a lock mechanism configured to maintain a minimum amount of anchor expansion. The invention also includes a method for endovascularly replacing a patient's heart valve. In some embodiments the method includes the steps of: endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve; expanding the anchor to a deployed configuration; and locking the anchor in the deployed configuration.