Abstract: Unique semi-circular papillary muscle and annulus bands are described that are useful for modifying the alignment of papillary muscles, a mitral valve annulus and/or a tricuspid valve annulus. Methods to effect the alignment are also described and an unique sizing device that can be used for such alignment is described.

Abstract: A multi-leaflet valve adapted to serve as a prosthesis for diseased native valve of a mammal is incorporated in self-expandable or inflatable endovascular stents or stents to form a combination which is introduced on a catheter with a guide wire into the circulatory system of the mammal to replace the diseased native valve. Once the combination is at the desired location the stent is caused to expand and affix itself to the patient's vessel wall. The prosthetic valve has the shape of a truncated cone that has an inflow and an outflow orifice with leaflets forming the outflow orifice and forming a plurality of commissures. A first flexible circular support is affixed in a substantially circular fashion around the truncated cone in proximity of the inflow orifice, and a second flexible circular support is affixed at the location of the commissures to form a circle around the truncated cone in proximity of the outflow orifice.

Abstract: A multi-leaflet valve adapted to serve as a prosthesis for diseased native valve of a mammal is constructed of biologic membrane or of biocompatible synthetic membrane. The valve has the shape of a truncated cone that has an inflow and an outflow orifice with leaflets forming the outflow orifice and forming a plurality of commissures. A first flexible stent is removably affixed in a substantially circular fashion around the truncated cone in proximity of the inflow orifice, and a second flexible stent is removably affixed at the location of the commissures to form a circle around the truncated cone in proximity of the outflow orifice. The stents maintain the shape of the valve during the surgical implantation procedure. Each stent independently can be left in the valve or can be removed during the implantation procedure based upon the judgement of the cardiac surgeon performing the implantation procedure.

Abstract: A multi-leaflet valve adapted to serve as a prosthesis for diseased native valve of a mammal is incorporated in self-expandable or inflatable endovascular stents or stents to form a combination which is introduced on a catheter with a guide wire into the circulatory system of the mammal to replace the diseased native valve. Once the combination is at the desired location the stent is caused to expand and affix itself to the patient's vessel wall. The prosthetic valve has the shape of a truncated cone that has an inflow and an outflow orifice with leaflets forming the outflow orifice and forming a plurality of commissures. A first flexible circular support is affixed in a substantially circular fashion around the truncated cone in proximity of the inflow orifice, and a second flexible circular support is affixed at the location of the commissures to form a circle around the truncated cone in proximity of the outflow orifice.

Abstract: A process for preparing pliable soft tissue specimen which are resistant to cracking and devoid of viable cells includes the steps of treating native soft tissue obtained from a donor by a gradually increasing gradient of aliphatic alcohol or other suitable water miscible polar organic solvent until the last alcohol (or other solvent) solution has at least 25% by volume of the organic liquid. Thereafter, the tissue specimen is treated with a solution containing glycerol or low molecular weight (<1000 D) polyethylene glycol, and polyethylene glycol of a molecular weight between approximately 6,000 to 15,000 D and heparin. Thereafter, the tissue specimen is briefly immersed in aqueous heparin solution, frozen and lyophilized. The tissue specimen is suitable for implantation as a homograft or xenograft, with or without rehydration.

Abstract: A pair of templates form a mold for substantially flat biological membranes to shape the membrane into a configuration that, after trimming of excess tissue, is adapted for forming a replacement aortic, pulmonary, tricuspid or mitral heart valve. Each template has three members joined to another laterally, with each member configured to form, together with its mating member, the mold for one leaflet or cusp of the replacement heart valve. The negative template has concave surfaces for each member and the positive template has convex surfaces which mate with the concave surfaces of the first template. Each of the templates is made of thin, shell like material and has beveled edges. The biological membrane is placed between the mating convex and concave surfaces of the two templates assembled to one another to form the membrane into the configuration of the three leaflets of the replacement heart valve.

Abstract: An anatomically designed atrioventricular valve is made of biologically compatible synthetic membrane or biological membrane of autologous, homologous or heterologous origin. A single piece of the selected membrane material is trimmed so as to form two unequal sheaths similar to the normal anterior and posterior mammalian mitral valve leaflets with a wide upper base to be sutured to the host's mitral annulus. These two leaflets are prolonged and tapered into two thin bands to be connected to the papillary muscles serving as replacements for the natural marginal chordae tendinae of the normal mitral valve. The two lateral sides of the membrane are joined to form a truncated cone with a wider upper circular base and a narrow extremity formed by the thin chordal bands. A set of sutures are placed between selected points at the base of the cone and the two thin prolongations serving as replacements for the strut or stay basal chords of the natural mitral valve.

Abstract: An aqueous solution containing a water miscible organic solvent, polyethylene glycol and heparine, is used to modify the tissue reactivity of an autologous tissue freshly obtained from a host mammal and to render the tissue temporarily more rigid than in its native state, and better suited for shaping, molding, handling and cutting prior to implantation into the host patient. The implant is highly resistant or immune to thickening, contraction and reduced fibrin deposition after it is implanted and exposed to the bloodstream of the host.

Abstract: A process for preparing pliable soft tissue specimen which are resistant to cracking and devoid of viable cells includes the steps of treating native soft tissue obtained from a donor by a gradually increasing gradient of aliphatic alcohol or other suitable water miscible polar organic solvent until the last alcohol (or other solvent) solution has at least 25% by volume of the organic liquid. Thereafter, the tissue specimen is treated with a solution containing glycerol or low molecular weight (<1000 D) polyethylene glycol, and polyethylene glycol of a molecular weight between approximately 6,000 to 15,000 D and heparin. Thereafter, the tissue specimen is briefly immersed in aqueous heparin solution, frozen and lyophilized. The tissue specimen is suitable for implantation as a homograft or xenograft, with or without rehydration.