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 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 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 prepared tissue for medical use with a patient is provided. Methods for preparing such tissue are also provided. Implantable tissue is provided by harvesting a tissue, such as but not limited to a pericardium tissue, and exposing the tissue to various cleaning, rinsing, treatment, separating, and fixation steps. The tissue of at least one embodiment is cleaned with distilled water, rinsed with isopropyl alcohol, and treated with a glutaraldehyde solution. The prepared tissue may be allowed to dry or partially hydrated prior to packaging and shipment. As such, the tissue can be implanted into the receiving patient in either a dry or wet state. The relatively thin yet strong tissue material is adapted for implanting within or grafting to human tissue. By way of example, the tissue may be used in a shunt, a valve, as graft material, as a patch, as a prosthetic tissue in a tendon and/or ligament, and a tissue product for wound management.
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.