Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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 gluteraldehyde. 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.

Abstract: The present invention comprises a percutaneously implantable replacement heart valve device and a method of making same. The replacement heart valve device comprises a stent member made of stainless steel or self-expanding nitinol, a biological tissue artificial valve means disposed within the inner space of the stent member. An implantation and delivery system having a central part which consists of a flexible hollow tube catheter that allows a metallic wire guide to be advanced inside it. The endovascular stented-valve is a glutaraldehyde fixed bovine pericardium which has two or three cusps that open distally to permit unidirectional blood flow.