This invention relates to the design and function of a compressible valve replacement prosthesis, collared or uncollared, which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed focuses on the deployment of a device via a minimally invasive fashion and by way of example considers a minimally invasive surgical procedure preferably utilizing the intercostal or subxyphoid space for valve introduction. In order to accomplish this, the valve is formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the annulus of a target valve such as a mitral valve or tricuspid valve.

Apparatus and methods are described including placing a valve frame within a subject's heart. The valve frame includes a valve frame body that is configured to support the prosthetic valve within the native atrio-ventricular valve, and at least one arm that is configured to extend from a ventricular portion of the valve frame. The at least one arm is deployed among chords of the native atrio-ventricular valve. Subsequently, at least a portion of the valve frame is rotated in a direction in which an interior of the arm faces, such as to modify shapes of the native valve leaflets and the ventricular structures, by recruiting and deflecting at least a portion of the chords. The frame body of the valve frame is then radially expanded, such as to hold the native valve leaflets and the ventricular structures at least partially in the modified shapes. Other applications are also described.

A prosthetic heart valve can include an outer support assembly, an inner valve assembly, which define between them an annular space, and a pocket closure that bounds the annular space to form a pocket in which thrombus can be formed and retained. Alternatively, or additionally, the outer support assembly and the inner valve assembly can be coupled at the ventricle ends of the outer support assembly and the inner valve assembly, with the outer support assembly being relatively more compliant in hoop compression in a central, annulus portion than at the ventricle end, so that the prosthetic valve can seat securely in the annulus while imposing minimal loads on the inner valve assembly that could degrade the performance of the valve leaflets.

A method comprises inserting a needle into a ventricle of a heart. The needle is configured to deliver a first anchoring element, a second anchoring element, and a tethering suture to the ventricle. The tethering suture is tethered between the first anchoring element and the second anchoring element. The method further comprises penetrating a first leaflet of a heart valve with the needle, penetrating a second leaflet of the heart valve with the needle, deploying the first anchoring element at a distal side of the second leaflet, retracting the needle from the first leaflet and the second leaflet, deploying the second anchoring element at a proximal side of the first leaflet, cinching the tethering suture to cause a desired amount of valve coaptation, and locking the tethering suture.

A sutureless implant for replacing damaged natural chordae tendineae of a human or possibly animal heart, the implant including a distal implant part, a proximal implant part, and an artificial chord. The distal implant part is configured to fit in a lumen of an implant delivery device and includes a self-spreading portion spreading radially outside when the distal implant part is released from the lumen, the self-spreading portion being capable of anchoring the distal implant part in human muscle tissue. The proximal implant part is configured to fit in the lumen of the implant delivery device and comprises a self-spreading portion spreading radially outside when the proximal implant part is released from the lumen, the self-spreading portion being capable of bearing on a tissue portion of leaflet tissue. The distal implant part and the proximal implant part are connected by the chord.

A prosthetic mitral valve with improved blood flow to the left ventricular outflow tract (LVOT). The prosthetic mitral valve includes an expandable outer stent having an atrial end and a ventricular end, and an expandable inner stent attached to and at least partially positioned within the outer stent. The inner stent has an inflow end, an outflow end and a connector securing a tether. A valve assembly including a cuff and a plurality of leaflets may be disposed within the inner stent. The outer stent is expandable from a delivery condition in which the outer stent is axially elongated to a deployed condition in which a first portion of the outer stent is folded upon a second portion of the outer stent to define a flange for engaging an atrial surface of a native valve annulus and to stabilize the prosthetic heart valve within the native valve annulus.

A method of reducing tricuspid valve regurgitation is provided, including implanting first, second, and third tissue anchors at respective different first, second, and third implantation sites in cardiac tissue in the vicinity of the tricuspid valve of the patient. The geometry of the tricuspid valve is altered by drawing the leaflets of the tricuspid valve toward one another by applying tension between the first, the second, and the third tissue anchors by rotating a spool that (a) winds therewithin respective portions of first, second, and third longitudinal members coupled to the first, the second, and the third tissue anchors, respectively, and (b) is suspended along the first, the second, and the third longitudinal members hovering over the tricuspid valve away from the annulus of the tricuspid valve. Other embodiments are also described.

Inflatable heart valve implants and methods utilizing those valves designed to reduce or eliminate the regurgitant jet associated with an incompetent atrioventricular valve. The heart valve implants, which are deployed via a transcatheter venous approach, comprise an inflatable balloon portion movably connected to an anchored guide shaft and movable from a distal position in the ventricle to a more proximal position between leaflets of a native atrioventricular valve. The range of movement of the inflatable valve body can be adjusted in situ after or before the guide shaft has been anchored to native heart tissue during surgery.

Methods and devices for transvascular prosthetic chordae tendinea implantation are disclosed. A catheter is advanced into the left atrium. From an atrium side, the catheter can be anchored to a superior surface of a mitral valve leaflet and a leaflet anchor can be advanced into the mitral valve leaflet to secure the mitral valve leaflet to a leaflet suture. A ventricular anchor is anchored to the wall of the ventricle to secure the ventricular wall to a ventricle suture. The leaflet suture and the ventricle suture may be tensioned and connected by a suture lock to form an artificial chordae.

A system for treating valvular regurgitation in a heart valve includes a flexible canopy and an elongated tether including an elastic portion and an inelastic portion. When the system is in a deployed configuration, a proximal end of the flexible canopy is coupled to an annulus of the heart valve and a distal end of the elongated tether is coupled to a ventricle. The flexible canopy is configured to overlay a first native leaflet of the heart valve, and tension on the elongated tether is applied and/or adjusted to prevent the first leaflet from prolapsing, to maximize coaptation of the flexible canopy with a second native leaflet of the heart valve, and to minimize regurgitation of the heart valve.