摘要:
A transcatheter, percutaneously implantable, prosthetic heart valve is provided that comprises a lattice frame and two or more integrated cusp and leaflet folded structures attached to the lattice frame. The two or more integrated cusp and leaflet folded structures each comprise a flat sheet of biocompatible membrane that is folded to include a substantially conical shape according to a flat folding pattern. The substantially conical shape is further formed by joining apposing sides of the substantially conical shape along a seam. The two or more integrated cusp and leaflet folded structures are each attached along their respective seams to the lattice frame in a direction substantially parallel to an axis of the lattice frame. Embodiments of valves described herein have application within the entire vascular system.
摘要:
A prosthetic heart valve implantable by catheter without surgery includes a substantially “dry” membrane or tissue material. In at least one embodiment, the tissue is folded in a dry state to form a tissue leaflet assembly that is then attached to a frame to form an implantable prosthetic heart valve. Alternatively, one or more tissue leaflets are operatively associated with a frame to form an implantable prosthetic heart valve. The implantable prosthetic heart valve is subsequently pre-mounted on an integrated catheter delivery system. The catheter delivery system that includes the implantable prosthetic heart valve is then packaged and transported while the tissue remains dry. The implantable prosthetic heart valve, while remaining substantially dry, can then be implanted into the receiving patient.
摘要:
A method of making a replacement heart valve device whereby a fragment of biocompatible tissue material is treated and soaked in one or more alcohol solutions and a solution of glutaraldehyde. The dried biocompatible tissue material is folded and rehydrated in such a way that forms a two- or three-leaflet/cusp valve without affixing of separate cusps or leaflets or cutting slits into the biocompatible tissue material to form the cusps or leaflets. After the biocompatible tissue material is folded, it is affixed at one or more points on the outer surface to the inner cavity or a stent.
摘要:
A prosthetic valve implantable by catheter without surgery includes a frame with an abluminal surface extending between a proximal end of the frame and a distal end of the frame, and a single layer of a biocompatible membrane material mounted to the abluminal surface of the frame. The single layer of biocompatible membrane is located such that an interior surface of the membrane sheet extends between the proximal end of the frame and the distal end of the frame, and resides radially exterior the abluminal surface of the frame. In at least one embodiment, the disposition of membrane sheet at all points of attachment is entirely exterior/abluminal to the frame, such that no part of the abluminal surface of the membrane sheet contacts the frame.
摘要:
A dual-balloon delivery catheter system includes a carrier segment that is a lead/carrier balloon or mandrel at a distal portion of a catheter. The carrier segment is sequentially arrayed with a more proximally positioned delivery segment, wherein the delivery segment is a delivery balloon or mandrel. The first carrier segment expands the stent-valve a sufficient amount to receive the delivery segment after the carrier segment is moved away from the sent-valve. The delivery segment is then positioned at the target site and the stent-valve is then deployed.