Prosthetic valved conduits are provided that include a leaflet construct coupled between two portions of a conduit. Each leaflet has a free edge and a leaflet attachment edge. The leaflet attachment edge is disposed between a first conduit distal end and a second conduit proximal end that are coaxial therebetween defining a junction.

The present disclosure relates to numerous delivery devices and methods for transcatheter prosthetic heart valve loading, deployment and delivery utilizing at least one suture. Disclosed delivery devices utilize improved suture routing methods and configurations that reduce suture tangling and also provide the ability to adjust the prosthetic heart valve expansion and contraction prior to the final release of the prosthetic heart valve from the delivery device.

Assembly methods for installing a valvular structure to an expandable annular frame of a prosthetic heart valve are described. The valvular structure has a multiple leaflets, each with a pair of tabs. Each tab of the leaflet has upper and lower portions. Commissures formed by paired tabs of adjacent leaflets are coupled to corresponding commissure windows to support the valvular structure within the frame. Each commissure window has upper and lower openings separated from each other by a crossbar and may have an H-shape. The upper and lower tab portions extend through the upper and lower openings, respectively, of the corresponding commissure window. One or more wedge members coupled to the tab portions can prevent the leaflet tab from passing back through the commissure window, thereby retaining the valvular structure to the annular frame.

The present invention is directed toward prosthetic heart valves that include an expandable frame and a leaflet assembly mounted therein, wherein the leaflet assembly is coupled to the frame via a plurality of commissure assemblies, formed from tabs of adjacent asymmetrical leaflets secured to each other, wherein at least one of the leaflet tabs includes a vertical tab portion folded over the tab of an adjacent leaflet.

A heart valve replacement device comprises a stent having a first end, a second end, an outer surface, and an inner surface, the inner surface defining a lumen; and a valve disposed within the lumen of the stent, the valve formed from a single sheet of tissue, the valve having an outer surface, an inner surface, and a thickness between the outer surface and the inner surface, the valve comprising at least three leaflets, wherein, the valve is attached to the stent with minimal sutures. The leaflets are formed with a curvilinear surface.

Some embodiments are directed to methods for serially expanding an artificial heart valve within a pediatric patient. For example, the artificial heart valve can be implanted into the pediatric patient during a first procedure, and then expanded during a second procedure to accommodate for the pediatric patient’s growth. Some embodiments include introducing an expander into the implanted valve when the frame is expanded to a first working diameter, and then actuating the expander to expand the frame to a second working diameter greater than the first working diameter, to accommodate for the pediatric patient’s growth.

The present invention concerns a prosthetic valve device for treatment of mitral valve insufficiency, as well as methods of manufacturing the device. The device comprises a main body with a flexible stent frame and a prosthetic material covering the stent frame at least partially, and a valve structure, wherein the valve structure is formed by wire-elements having elongated loop-structures with prosthesis material attached thereto.

The present invention concerns a tissue-engineered medical device, as well as a method for the production said medical device, comprising the following steps: providing a polymer scaffold comprising a mesh comprising polyglycolic acid, and a coating comprising poly-4-hydroxybutyrate; application of a cell suspension containing preferably human cells to the polymer scaffold; placement of the seeded polymer scaffold in a bioreactor and mechanical stimulation by exposure to a pulsatile flux of incremental intensity, thereby forming an extracellular matrix; mounting of the graft on a conduit stabilizer and incubation in cell culture medium; decellularisation of the graft in a washing solution; nuclease treatment of the graft; and rinsing of graft. The invention further comprises and various steps of quality control of the tissue-engineered medical device.

A replacement heart valve implant may include a tubular anchor member actuatable between a delivery and a deployed configuration, the tubular anchor member including an inflow end, an outflow end, and a plurality of anchor member intersection points, and defining a longitudinal axis extending from the inflow end to the outflow end, a plurality of valve leaflets, and a seal member secured to the tubular anchor member at the inflow end. An end surface of each of the plurality of valve leaflets may abut an inner-facing surface of the seal member. The plurality of valve leaflets each define a secured end and a free end. The secured end may be attached to the seal member adjacent the inflow end. The secured end may define the end surface, and the end surface may face toward the outflow end when the plurality of valve leaflets is in an everted position.

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.