Abstract: Prosthetic valves, methods of making medical devices, and methods of treatment are provided. The prosthetic valves of the invention have a valve portion moveable between first and second positions, and a spacing member that has a thickness and protects a portion of the valve portion from contact with a wall of a vessel in which the prosthetic valve is implanted, and/or another structural component of the prosthetic valve, such as a support frame.

Abstract: Apparatus is provided that includes a valve prosthesis for attachment to a native valve complex of a subject. The prosthesis is configured to assume a compressed delivery state and an uncompressed implantation state. The prosthesis includes a support frame, which is shaped so as to define an upstream inlet having upstream-most portions that are tapered in an upstream direction toward a central longitudinal axis of the prosthesis when the prosthesis assumes the compressed delivery state. The prosthesis further includes a flexible prosthetic heart valve component, coupled to the support frame. Other embodiments are also described.

Abstract: A percutaneously inserted bistable heart valve prosthesis is folded inside a catheter for transseptal delivery to the patient's heart for implantation. The heart valve has an annular ring, a body member having a plurality of legs, each leg connecting at one end to the annular ring, claws that are adjustable from a first position to a second position by application of external force so as to allow ingress of surrounding heart tissue into the claws in the second position, and leaflet membranes connected to the annular ring, the body member and/or the legs, the leaflet membranes having a first position for blocking blood flow therethrough and a second position for allowing blood flow therethrough. The heart valve is designed such that upon removal of the external force the claws elastically revert to the first position so as to grip the heart tissue positioned within the claws, thereby holding the heart valve in place. The body member and claws may be integrated into a one-piece design.

Abstract: An improved trileaflet mechanical heart valve 100 can include an improved leaflet 110. The valve 100 and leaflet 110 provide improved flow characteristics, minimize blood clotting behind the leaflets, and provide more natural opening and closing times. The valve can include a valve housing 105 which contains pivot/hinge mechanism (130, 200, and 300) for allowing rotation of and retention of the leaflets 110. The valve housing 105 can also be solid or include windows or openings 125 which allows for washing of the pivot/hinge mechanism (130, 200, and 300) as well as the leaflets 110. The housing 105 preferably has a top surface that is scalloped shaped when viewed from the side such that the wetted area is reduced. The novel leaflets 110 are airfoil-like having a complex S-shaped curvature on their outer surface. This novel geometry, when combined with the location of the leaflet's pivot axis, causes a tendency for the leaflets 110 to rotate towards the closed position.

Abstract: There is disclosed a heart valve prosthesis having a configuration such that blood flow through it has a helical flow pattern such as to substantially reduce or eliminate turbulence and dead flow regions in the blood flow.

Abstract: A valve shield comprising a shaped sheet of material adapted to be affixed to the annulus of a valve and adapted to extend over at least a portion of at least one leaflet of the valve so as to assist or replace the closing function of that valve leaflet.

Abstract: A vessel valve including a sleeve or ring having a central opening and openable and closeable flap elements intended to allow the flow of blood through the central opening in one direction, whereas the flap elements are designed as circle segments, and the sector angle is 360 ? ° n wherein n is a number of circle segments and is equal to 3, 4, 5 or 6, and wherein each flap element at its outer edge is pivotably connected to an inwardly directed flange on the inside of the ring so that in a closed position they co-operate to form a sealing body and in an open position they allow free passage of blood. The ring is composed of n sections, whose pair-wise juxtaposed ends form recesses in the flange accommodating hinge elements which are arranged in the middle of the outer edge of each of the flap elements and which with assembled sections are locked by undercutting; and a method for the manufacture of such vessel valve.

Abstract: The present invention provides a valve configured for insertion on the proximal and distal sides of a heart valve annulus to replace the heart valve of a patient. The valve comprises a first substantially annular portion adapted to be positioned on a proximal side of the annulus of a patient and a second substantially annular portion adapted to be positioned on a distal side of the annulus of a patient, wherein at least one of the first and second substantially annular portions is movable towards the other portion to a clamped position to clamp around the annulus. The second portion has a flow restricting portion extending therefrom and is movable between a first position to permit the flow of blood and a second position to restrict the flow of blood. In one embodiment, the valve has a suture joining the first and second portions to draw the first and second portions into closer proximity and a cinch member to secure the suture to maintain the first and second portions in the clamped position.

Abstract: There is disclosed a heart valve prosthesis having a configuration such that blood flow through it has a helical flow pattern such as to substantially reduce or eliminate turbulence and dead flow regions in the blood flow.

Abstract: A prosthetic heart valve for replacing a native heart valve is provided and includes a generally circular heart valve body having an inner wall defining a lumen configured to allow blood flow therethrough. Occluders are configured to rotate about opposed occluder ends between an open position and a closed position. The minor radius arcs cooperate with the occluders to allow the occluders to block blood flow through lumen when in a closed position yet provide an increased lumen when the occluders are in an open position.

Abstract: A mechanical heart valve prosthesis has a generally rectangular orifice and two leaflets that move between a closed position nearly perpendicular to blood flow and an open position nearly parallel to blood flow. Due to the uniform dimension of a rectangle, the leaflets are hinged at the periphery of the orifice, and present a single large central flow region to the blood when opened. The base provides several means of constraining the leaflet rotation during opening and closing.

Abstract: A prosthetic valve adapted to be inserted into a blood vessel and held in a desired position therein. The valve includes an annular support ring having a longitudinal axis and defining a substantially circular central opening for passage of blood. The support ring has an outer wall that may be formed with a central annular depression. A leaflet is mounted on the support ring for pivotal movement between a closed position wherein the leaflet substantially blocks the central opening and an open position wherein blood is permitted through the opening. The valve is adapted to be inserted into the blood vessel such that the support ring longitudinal axis is substantially coincident with an axis of elongation of said blood vessel and held in such position in suitable fashion, such as by suturing or by way of a tightened cord holding a proximate portion of the blood vessel against the support outer wall if it is formed with an annular depression.

Abstract: A mechanical heart valve prosthesis has a generally rectangular orifice and two leaflets that move between a closed position nearly perpendicular to blood flow and an open position nearly parallel to blood flow. Due to the uniform dimension of a rectangle, the leaflets are hinged at the periphery of the orifice, and present a single large central flow region to the blood when opened. The base provides several means of constraining the leaflet rotation during opening and closing.

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: A bileaflet heart valve comprising an annular base and pivoting leaflets. Each leaflet is “free-floating” within recesses without fixed rotational axis in order to increase translational movement and redistribute stresses. Each recess fluidly communicates with a groove extending at least partially around the inner surface of the annular base and fluid flow is directed through the recesses at different angles during antegrade circulation, retograde circulation, and valve closure. A recess entrance angle to each of the recesses in certain embodiments is preferably less than about 35° and the pivoting mechanism within each recess includes first and second fulcrum edges of each leaflet shiftably engaged with side surfaces of the respective recesses. The leaflets have a beveled bottom side having two separate planar surfaces which lie at an angle to one another.

Abstract: An improved artificial mechanical heart valve prosthesis having an improved leaflet hinge mechanism which improves washing of the hinge recess, reduces leaflet closing impact force and decreases noise and wear. A generally annular valve body having an annular interior surface extending between an inflow rim and an outflow rim thereof defines an annular orifice therethrough. A pair of leaflets are supported on said annular valve body for alternately blocking blood flow in an inflow direction when seated against the annular interior side wall in a closed position and then allowing the flow of blood through said annular orifice in a predetermined blood outflow direction when rotated into an open position. Each leaflet is supported for pivotal movement by a pair of hinge mechanisms comprising a pair of convexly extending leaflet ears that each fit within a hinge recess formed in parallel planar surfaces of the annular interior side wall.

Abstract: A heart valve prosthesis which incorporates a substantially permanently implantable abutment structure which is surgically attached to a native heart valve annulus through utilization of a resilient metal substructure having an attachment portion which moves into engagement with a native heart annulus upon being released from a retracted orientation. The system employs a positioning instrument which locates the abutment structure and associated heart valve prosthesis at the proper location for releasing the attachment components. Mechanical heart valve components including an occluder function are removably attached to the abutment structure using sutures, such that the valve function itself may be subsequently replaced.

Abstract: A heart valve prosthesis includes a valve housing having an opening formed therein having an inmost arcuate surface and a leaflet pivotally mounted in the opening for movement between an open position and a closed position with the inmost arcuate surface. The leaflet has an outmost edge providing multiple points of contact with the housing. The leaflet also forms a leakage gap adjacent the leaflet major radius and between the inmost and outmost surfaces such that the multiple points of contact are displaced from the leaflet major radius and are adjacent to and on opposite sides of the leakage gap. One or several such leaflets may be provided in the housing. Each leaflet respectively includes the leakage gap and the adjacent multiple points of contact.

Abstract: Prosthesis for the replacement of heart valves, with a valve ring (10) with a radius R, in which at least two substantially elongated wing valves (12, 14, 16) are mounted so as to rotate about in each case an axis (18) located in the ring plane, the axes (18) in the projection on the ring plane having a distance of 0.5 R to 0.9 R from the center of the ring plane and the edges of the inwardly directed portions engage in flush manner on the edges of the corresponding portions of the other wing valves (12, 14, 16) and in the area (20) of the wing valves (12, 14, 16) pointing in the flow direction in the opened state thereof, said valves are provided with a bevel (24), constructed as a sharp break-away edge (22), running from the outside to the inside in the flow direction.

Abstract: The invention provides a prosthetic valve having a generally annular frame with three post and three scallops. The frame is tri-symmetric with an axis of symmetry defined by the axis of blood flow through the valve. The external surface of the frame is generally cylindrical with diameter D. Each leaflet has a truncated spherical surface adjacent to its free edge. The spherical surface is joined tangentially to a truncated conical surface. The half angle of the truncated cone is approximately 37.5°. The radius of the sphere is approximately D/2−0.5 (mm). The leaflet surface is axi-symmetrical with the axis of symmetry being perpendicular to the axis of the valve frame and blood flow.