Abstract: The techniques of this disclosure generally relate to a valve prosthesis having a one piece molded prosthetic valve and a reinforcement member attached to the prosthetic valve directly adjacent a cylindrical inflow end of the prosthetic valve. The reinforcement member is additional material outside the leaflet belly region that gets attached directly to a stent structure to provide reinforcement and durability of the prosthetic valve.

Abstract: The techniques of this disclosure generally relate to a valve prosthesis having a stent structure and a prosthetic valve coupled to the stent structure. The stent structure includes an inflow portion having an outflow crown ring and an outflow portion comprising an outflow portion crown ring. The outflow crown ring includes outflow struts and outflow crowns coupled to the outflow struts. The outflow portion crown ring includes outflow portion struts and superior crowns coupled to the outflow portion struts. The valve prosthesis further comprises an inferior tissue bumper covering the outflow crowns and a superior tissue bumper covering the superior crowns. The tissue bumpers provide a buffer, sometimes called a padding or cushion, between the prosthetic valve and outflow crowns and superior crowns. In this manner, the tissue bumpers protect the prosthetic valve from being damaged by the outflow crowns and the superior crowns.

Abstract: A transcatheter heart valve prosthesis and a method of assembling the transcatheter heart valve prosthesis are disclosed. The heart valve prosthesis includes a valve-skirt assembly having an inner skirt, a frame, an outer wrap backing and an outer wrap. The method includes: tacking the valve-skirt assembly within the frame; attaching the inner skirt below commissure posts of the frame; attaching commissures of the valve component to the commissure posts; attaching a plurality of outer wrap backings to the inner skirt; attaching the outer wrap backings and the inner skirt to the frame; attaching tissue bumpers to struts in an outflow section of the frame; attaching an outer wrap and the inner skirt to the frame; attaching the outer wrap to the inner skirt proximate inflow edges thereof; and attaching the outer wrap to the inner skirt and to the outer wrap backings proximate respective outflow edges thereof.

Abstract: A method of manufacturing a heart valve prosthesis includes cutting a flat sheet of a valve material into a single-piece valve pattern having two or more valve leaflet regions and a valve skirt region. The method also includes arranging the two or more valve leaflet regions of the single-piece valve pattern into a mold for forming a leaflet belly for each of the two or more valve leaflet regions. Further, the method includes fixing, while arranged in the mold, a shape of the leaflet belly of each of two or more valve leaflet regions of the single piece-valve pattern. The method additionally includes creating a side seam by attaching two longitudinal edges of the single-piece valve pattern, to thereby form a tubular valve subassembly with two or more valve leaflets. The method includes attaching the tubular valve subassembly within a tubular frame to form a heart valve prosthesis.

Abstract: Novel tools and techniques are provided for implementing protection of at least one tissue layer of a medical device or implant during crimping of the medical device or implant. In various embodiments, an implant tissue protection tool may include an outer portion configured to surround one or more outer segments of at least one tissue layer of a medical device to be implanted into a body of a subject and at least one protrusion (which may be affixed to a surface of the outer portion) configured to minimize or prevent occurrence (or likelihood of occurrence) of the at least one tissue layer (in some cases, leaflet material, or the like) of the medical device passing through at least one opening defined by a frame structure of the medical device during crimping of the medical device by a crimping device in preparation for implantation into the body of the subject.

Abstract: Aspects of the disclosure include apparatuses for and methods of removing a ligation clip interconnecting two mitral valve leaflets. Methods can include providing a mitral valve having first and second valve leaflets interconnected with a ligation clip. The ligation clip includes a base supporting a first and second retaining arms each having an end opposite the base. The first and second valve leaflets are compressed between the first and second retaining arms. The methods further include physically separating the ligation clip from both of the first and second leaflets with the apparatus, which is configured to dislodge the first and second leaflets from the ligation clip. The apparatuses are further configured to withdraw the ligation clip from the patient along with the apparatus.

Abstract: Methods of transcatheter delivery of a prosthetic heart valve. A distal region of a guide member assembly is advanced into a heart of a patient. The distal region is docked to native anatomy of the heart. A delivery device, including a collapsed prosthetic heart valve, is advanced over the docked guide member assembly. The collapsed prosthetic heart valve is located at an implantation site. The prosthetic heart valve is deployed from the delivery device, and then the delivery device is removed from the patient. At least a portion of the guide member assembly is removed from the patient. In some embodiments, the docking structure is docked to one or more of native mitral valve leaflets, chordae in the left ventricle, or walls of the left ventricle as part of a transseptal mitral valve delivery procedure.

Abstract: Methods of transcatheter delivery of a prosthetic heart valve. A distal region of a guide member assembly is advanced into a heart of a patient. The distal region is docked to native anatomy of the heart. A delivery device, including a collapsed prosthetic heart valve, is advanced over the docked guide member assembly. The collapsed prosthetic heart valve is located at an implantation site. The prosthetic heart valve is deployed from the delivery device, and then the delivery device is removed from the patient. At least a portion of the guide member assembly is removed from the patient. In some embodiments, the docking structure is docked to one or more of native mitral valve leaflets, chordae in the left ventricle, or walls of the left ventricle as part of a transseptal mitral valve delivery procedure.

Abstract: Methods of transcatheter delivery of a prosthetic heart valve. A distal region of a guide member assembly is advanced into a heart of a patient. The distal region is docked to native anatomy of the heart. A delivery device, including a collapsed prosthetic heart valve, is advanced over the docked guide member assembly. The collapsed prosthetic heart valve is located at an implantation site. The prosthetic heart valve is deployed from the delivery device, and then the delivery device is removed from the patient. At least a portion of the guide member assembly is removed from the patient. In some embodiments, the docking structure is docked to one or more of native mitral valve leaflets, chordae in the left ventricle, or walls of the left ventricle as part of a transseptal mitral valve delivery procedure.