This application relates to methods, systems, and apparatus for replacing native heart valves with prosthetic heart valves and treating valvular insufficiency. In a representative embodiment, a support frame configured to be implanted in a heart valve comprises a main body formed by formed by a plurality of inner members forming an inner clover and a plurality of outer members forming an outer clover. The support frame can include gaps located between inner members of the plurality of inner members and outer members of the plurality of outer members. The inner clover can be radially inside the outer clover, and the outer clover can have larger dimensions than the inner clover. The support frames herein can be radially expandable and collapsible.

Embodiments of the present disclosure include an implantable assembly for a native heart valve that includes a prosthetic heart valve and a braided support structure. The prosthetic valve includes a frame and prosthetic leaflets. The braided support structure has an inner braided layer and an outer braided layer. The outer braided layer is disposed over the inner braided layer. The outer braided layer is less porous to blood than the inner braided layer. The braided support structure defines a plurality of arms that are angularly spaced around the prosthetic heart valve such that each arm extends radially outwardly from the prosthetic heart valve. Other embodiments are also described.

An expandable prosthetic valve is implantable within a native mitral valve by terminal ends of ventricular anchors of the prosthetic valve moving outwardly from a constrained delivery position of the ventricular anchors, while the ventricular anchors are positioned within the atrium. Then, a portion of the expandable prosthetic valve containing the ventricular anchors is advanced through the native mitral valve into the ventricle. Terminal ends of atrial anchors of the prosthetic valve move outwardly relative to a portion of an annular valve body of the prosthetic valve while the atrial anchors are at least partially positioned within the atrium. Next, the annular valve body is radially expanded while the ventricular anchors are in the ventricle and the atrial anchors are in the atrium, thereby anchoring native heart valve tissue between the atrial anchors and ventricular anchors. Other embodiments are also described.

A leaflet positioning and fixing clip and a narrow-environment orientation system thereof are provided. The clip includes a fixing element, a lower gripping arm assembly sleeved outside the fixing element, an upper gripping arm assembly sleeved outside the lower gripping arm assembly, a pull rope controlling the upper gripping arm assembly to move, and an occlusive film attached below the lower gripping arm assembly. The upper gripping arm assembly includes an upper central fixing plate and upper gripping arms radially distributed around the upper central fixing plate. The lower gripping arm assembly includes a lower central fixing plate and lower gripping arms. There are at least two upper gripping arms mated with at least two lower gripping arms to form grippers for gripping a tricuspid valve. The occlusive film is stably positioned in a center of the tricuspid valve through the grippers .

A leaflet positioning and fixing clip and a narrow-environment orientation system thereof are provided. The clip includes a fixing element, a lower gripping arm assembly sleeved outside the fixing element, an upper gripping arm assembly sleeved outside the lower gripping arm assembly, a pull rope controlling the upper gripping arm assembly to move, and an occlusive film attached below the lower gripping arm assembly. The upper gripping arm assembly includes an upper central fixing plate and upper gripping arms radially distributed around the upper central fixing plate. The lower gripping arm assembly includes a lower central fixing plate and lower gripping arms. There are at least two upper gripping arms mated with at least two lower gripping arms to form grippers for gripping a tricuspid valve. The occlusive film is stably positioned in a center of the tricuspid valve through the grippers.

Described embodiments are directed toward centrally-opening leaflet prosthetic valve devices having synthetic leaflets that are configured to promote and encourage tissue ingrowth thereon and/or therein. The leaflets are coupled to a leaflet frame to form a prosthetic valve suitable for use in biological anatomy.

A system for repairing a valve leaflet in minimally invasive surgery includes: a delivery device comprising: an operating handle; an outer delivery tube coupled to the operating handle; a delivery needle coupled to the operating handle; and a pushing tube coupled to the operating handle. The system further comprises a repair component comprising an anchor and a connection wire. The delivery device is configured to perform, in response to a trigger operation, a linkage release operation that includes actuating the delivery needle and releasing the repair component.

Bioabsorbable medical devices such as vascular closures, mitral chorea replacements, and mitral leaflet extensions are provided.

An implantable device or implant includes an anchor portion comprising one or more anchors. The anchors are configured to attach to one or more leaflets of a native heart valve. The anchors are configured to move between an open position and a closed position. The device or implant includes an indication feature that is movable between an allowable tension position and an exceeded tension position. When the anchors are attached to the leaflets of the native heart valve, the indication feature indicates to a user when an amount of force applied to the anchor portion by the leaflets of the native heart valve exceeds a pre-set or predetermined amount of force.

A trans-apical implant includes a spacer defining spacer cavity configured to be expanded from a retracted position, a shaft extending from the spacer, the shaft defining an inflation lumen fluidly coupled to the spacer cavity and configured to be fluidly coupled to an expansion medium source, and a spacer valve assembly disposed within at least one of the spacer or shaft, the spacer valve assembly configured to allow selectively allow an expansion medium to flow into the spacer cavity to be selectively expand the spacer from a retracted position to an expanded position.

The invention is a method for reducing regurgitation through a mitral valve. The device and method is directed to an anchor portion for engagement with the heart wall and an expandable valve portion configured for deployment between the mitral valve leaflets. The valve portion is expandable for preventing regurgitation through the mitral valve while allowing blood to circulate through the heart. The expandable valve portion may include apertures for reducing the stagnation of blood. In a preferred configuration, the device is preferably configured to be delivered in two-stages wherein an anchor portion is first delivered and the valve structure is then coupled to the anchor portion. In yet another embodiment, the present invention provides a method of forming an anchor portion wherein a disposable jig is used to mold the anchor portion into a three-dimensional shape for conforming to a heart chamber.