Abstract: A bioprosthetic valve stent is fabricated from a hydrogel, and a bioprosthetic heart valve comprises such a stent. A method for fabricating a hydrogel bioprosthetic valve stent comprises filling a mold cavity with a solution of a hydrogel, allowing the hydrogel to solidity, removing the solidified hydrogel from the mold cavity and hydrating the hydrogel.

Abstract: Expandable heart valves for minimally invasive valve replacement surgeries are disclosed. In a first embodiment, an expandable pre-assembled heart valve includes a plastically-expandable annular base having plurality of upstanding commissure posts. A tubular flexible member including a prosthetic section and a fabric section is provided, with the prosthetic section being connected to the commissure posts and defining leaflets therebetween, and the fabric section being attached to the annular base. In a second embodiment, an expandable heart valve includes an annular tissue-engaging base and a subassembly having an elastic wireform and a plurality of leaflets connected thereto. The annular base and subassembly are separately stored and connected just prior to delivery to the host annulus. Preferably, the leaflet subassembly is stored in its relaxed configuration to avoid deformation of the leaflets. The expandable heart valves may be implanted using a balloon catheter.

Abstract: Methods and apparatus for direct coronary revascularization wherein a transmyocardial passageway is formed between a chamber of the heart and a coronary blood vessel to permit blood to flow therebetween. In some embodiments, the transmyocardial passageway is formed between a chamber of the heart and a coronary vein. The invention includes unstented transmyocardial passageways, as well as transmyocardial passageways wherein protrusive stent devices extend from the transmyocardial passageway into an adjacent coronary vessel or chamber of the heart. The apparatus of the present invention include protrusive stent devices for stenting of transmyocardial passageways, intraluminal valving devices for valving of transmyocardial passageways, intracardiac valving devices for valving of transmyocardial passageways, endogenous tissue valves for valving of transmyocardial passageways, and ancillary apparatus for use in conjunction therewith.

Abstract: A highly flexible tissue-type heart valve is disclosed having a structural stent in a generally cylindrical configuration with cusps and commissures that are permitted to move radially. The stent commissures are constructed so that the cusps are pivotably or flexibly coupled together at the commissures to permit relative movement therebetween. The stent may be cloth-covered and may be a single element or may be made in three separate elements for a three cusp valve, each element having a cusp portion and two commissure portions; adjacent commissure portions for each pair of adjacent stent element combining to form the stent commissures. If the stent has separate elements their commissure portions may be pivotably or flexible coupled, or may be designed to completely separate into independent leaflets at bioresorbable couples. The cloth covering may have an outwardly projecting flap that mates with valve leaflets (e.g., pericardial leaflets) along the cusps and commissures.

Abstract: A trileaflet biological prosthetic heart valve comprising a thin, rigid annular outer frame which supports three elastic, laminated spring inner frames which in turn provide consistent geometric form and structure for attachment of tissue leaflets.

Abstract: A heart valve prosthesis and method of implanting the prosthesis are disclosed. A valve is mounted within a support apparatus that is deformable between a first condition and a second condition. The prosthesis has a cross-sectional dimension in the second condition that is less than a cross-sectional dimension of the supported valve when in first condition. The prosthesis can be implanted into a patient's heart, such as during a direct vision procedure through a tubular implantation apparatus that maintains the prosthesis in its second condition until discharged from the tubular apparatus.

Abstract: An apparatus and a method for constructing a heart valve prepared from autologous tissue is disclosed. Three tissue leaflets are held in place with tissue anchors on a tissue mounting frame having an annular base and a plurality of commissure posts extending from the base. An elastomeric sheath rests gently on the tissue leaflets to prevent the leaflets from coming off of the anchor hooks and encloses the leaflets to form valve cusps. The leaflets touch each other on a coaptation line with an angle of approximately 65° C. relative to the commissure post. The heart valves can be constructed intraoperatively in a short time, typically ten minutes. The low coaptation angle and the fact that the leaflets are held in place without being clamped between two unyielding members minimize stress on the tissue.

Abstract: A supported bioprosthetic heart valve is provided. The valve includes a stent and a bilogical valve member. The stent has an annular frame defined by a support rail. The support rail is formed to define a triad of axially-projecting circumferentially-spaced commissure posts, each post having an inverted U-shaped configuration and a pair of legs. Each of the pair of legs has an upper end and a lower end. The lower end of each leg merges smoothly with the lower end of a leg of an adjacent commissure post. A sleeve having an inflow end and an outflow end is fitted around the annular frame. The biological valve member is defined by a tubular wall and three leaflets, the three leaflets being attached to the tubular wall and axially converging along three commissures. The biological valve member has a shape which fits the contour of the support rail and is disposed under the support rail. The biological valve member is sutured to the support rail and the outflow end of the sleeve.

Abstract: A method for producing a non-immunogenic and durable living graft involves the recellularization of a decellularized heart valve allograft or xenograft by recipient cells after implantation of such graft into a living patient. Decellularized allograft or xenograft grafts which have not been exposed to a cytotoxic environment are treated with either chemotactic factors or cell adhesion factors, or both, to retain desirable recipient cells into the tissue graft after implantation.

Abstract: A prosthetic cardiac valvular member of flexible material includes a flexible stent member which may be either attached to the cardiac valvular member or molded therein. The stent member is formed by a plurality of adjacent filaments which are bound together by suturing, braiding, jacketing or encapsulating. The prosthetic cardiac valvular member may be either a flexible heart valve or an annuloplasty ring. Post members are formed into the stent member when the stent member is used in the flexible heart valve.

Abstract: An apparatus and a method for constructing a heart valve prepared from autologous tissue. Three tissue leaflets are held in place with tissue anchors on a tissue mounting frame having an annular base and a plurality of commissure posts extending from the base. An elastomeric sheath rests gently on the tissue leaflets to prevent the leaflets from coming off of the anchor hooks and encloses the leaflets to form valve cusps. The leaflets touch each other on a coaptation line with an angle of approximately 65° relative to the commissure post. The heart valves can be constructed intraoperatively in a short time, typically ten minutes. The low coaptation angle and the fact that the leaflets are held in place without being clamped between two unyielding members minimize stress on the tissue.

Abstract: A stent includes an elongated stent member having a plurality of post members. Each post member includes a pair of opposite sides. A first end of each post member includes an arcuate apex interconnecting the opposite sides. A second end of each post member has an open end. The opposite sides are angled to converge toward each other at the second end. The second end of each post member is connected to an adjacent post member by a stent portion. Each opposite side and each stent portion converge at an angle of less than 90°. The opposite sides are angled to converge toward each other at the second end.

Abstract: A multiple-sided medical device comprises a frame comprising wire or other resilient material and having a series of bends and interconnecting sides. The device has both a flat configuration and a second, folded configuration which a generally serpentine shape. The device is pushed from a delivery catheter into the lumen of a duct or vessel and may include one or more barbs for anchoring purposes. A full or partial covering of fabric or other flexible material such as DACRON, PTFE, or a collagen-based material such as small intestinal submucosa (SIS), may be sutured or attached to the frame to form an occlusion device, a stent graft, or an implantable, intraluminal valve such as for correcting incompetent veins in the lower legs and feet.

Abstract: A heart valve prosthesis including a heart valve formed of a flexible material. An elongated stent member is provided in the valve and includes terminal ends. A plurality of flexible post members are formed in the stent member. Each post member includes a pair of opposite sides. A crimp collar interconnects the terminal ends of the stent member. The crimp collar is positioned between adjacent post members. A first radius is formed in the stent member between the crimp collar and an adjacent side of each adjacent post member. A plurality of second radii are formed in the stent member between an opposite side of a first one of the adjacent post members and an opposite side of a second one of the adjacent post members. The second radii are greater than each first radius.

Abstract: An apparatus and method are disclosed for supporting a heart valve with a flexible girdle. The girdle has an elongated cylindrical sidewall having an axial length at least commensurate with the heart valve. The girdle is disposed around a tubular valve wall of the heart valve being implanted so that the inflow end of the girdle is adjacent the inflow end of the tubular valve wall. The inflow ends of the girdle and heart valve may then be sutured together to implant the valve. The girdle provides support to stabilize the heart valve and inhibit deformation thereof.