Abstract: A device for regulating blood pressure between a patient's left atrium and right atrium comprises an hourglass-shaped stent comprising a neck region and first and second flared end regions, the neck region disposed between the first and second end regions and configured to engage the fossa ovalis of the patient's atrial septum; and a one-way tissue valve coupled to the first flared end region and configured to shunt blood from the left atrium to the right atrium when blood pressure in the left atrium exceeds blood pressure in the right atrium. The inventive devices may reduce left atrial pressure and left ventricular end diastolic pressure, and may increase cardiac output, increase ejection fraction, relieve pulmonary congestion, and lower pulmonary artery pressure, among other benefits. The inventive devices may be used, for example, to treat subjects having heart failure, pulmonary congestion, or myocardial infarction, among other pathologies.

Abstract: A prosthetic stented heart valve which includes a compressible and expandable stent structure having first and second opposite ends, an expanded outer periphery, and a compressed outer periphery that is at least slightly smaller than the expanded outer periphery when subjected to an external radial force. The valve further includes a valve segment comprising a dual-layer sheet formed into a generally tubular shape having at least one longitudinally extending seam, and a plurality of leaflets formed by attachment of an outer layer of the dual-layer sheet to an inner layer of the dual-layer sheet in a leaflet defining pattern. The valve segment is at least partially positioned within the stent structure. The valve may further include at least one opening in the outer layer of the dual-layer sheet that is spaced from both the first and second ends of the stent structure.

Abstract: A surgical sutureless valve that is attached to a stent frame for delivery to a location in a patient using percutaneous implantation devices and methods.

Abstract: An anatomically approximate prosthetic heart valve includes dissimilar flexible leaflets, dissimilar commissures and/or a non-circular flow orifice. The heart valve may be implanted in the mitral position and have one larger leaflet oriented along the anterior aspect so as to mimic the natural anterior leaflet. Two other smaller leaflets extend around the posterior aspect of the valve. A basic structure providing peripheral support for the leaflets includes two taller commissures on both sides of the larger leaflet, with a third, smaller commissure between the other two leaflets. The larger leaflet may be thicker and/or stronger than the other two leaflets. The base structure defines a flow orifice intended to simulate the shape of the mitral annulus during the systolic phase. For example, the flow orifice may be elliptical.

Abstract: A prosthetic valve assembly for implantation within a native aortic valve using a catheterization technique. The prosthetic valve assembly includes a collapsible and expandable metallic frame. The frame is constructed to resist the recoil forces of the native aortic valve. The frame may be formed with a concave profile. A valvular structure made with pericardial tissue is sewn to the frame for permitting blood flow in one direction. An internal cover is provided along an internal surface of the frame and provides a sleeve which prevents blood from passing through gaps in the frame.

Abstract: A prosthetic mitral heart valve including a contoured sewing ring that better matches the mitral valve annulus. The sewing ring includes an inflow end and an outflow end, the outflow and having at least one raised portion. There may be two raised portions located approximately 120° apart from each other and designed to register with two anterior trigones of the mitral valve annulus. The sewing ring may be formed by a suture-permeable annular member surrounded by a fabric covering, the annular member desirably being molded of silicone. The raised portion(s) may gently curve upward to a height of about 2 mm above the adjacent portions of the outflow end of the sewing ring. The sewing ring may also be constructed so as to be more flexible around a posterior aspect than around an anterior aspect to accommodate calcified tissue more commonly found around the posterior annulus. The contoured sewing ring can be combined with various types of heart valve including bioprosthetic and mechanical valves.

Abstract: An valve prosthesis, such as an artificial venous valve, having a support frame and leaf structure comprising one or more leaflets in which the outer edge of each leaflet engages the inner circumference of the bodily passageway along a serpentine path urged against the passageway by an expandable frame, while the inner edges move in response to fluid to restrict retrograde flow. Optionally, one or more elements can extend from the support frame/leaf structure to provide centering support and/or protection from the leaflet adhering to the vessel wall. In one embodiment, the centering support structure comprises a second or third expandable frames attached to and extending from the proximal and/or distal ends of main valve structure and support frame. In another embodiment, one or more support elements extend outward from the valve support frame to engage the vessel wall to provide greater longitudinal stability.

Abstract: A valve prosthesis which is especially useful in the case of aortic stenosis and capable of resisting the powerful recoil force and to stand the forceful balloon inflation performed to deploy the valve and to embed it in the aortic annulus, comprises a collapsible valvular structure and an expandable frame on which said valvular structure is mounted. The valvular structure is composed of physiologically compatible valvular tissue that is sufficiently supple and resistant to allow the valvular structure to be deformed from a closed state to an opened state. The valvular tissue forms a continuous surface and is provided with strut members that create stiffened zones which induce the valvular structure to follow a patterned movement in its expansion to its opened state and in its turning back to its closed state.

Abstract: A cardiovascular prosthetic valve includes a cuff having a distal end and a proximal end. An inflatable structure is coupled to the cuff and has at least one inflatable channel that forms a toroidal structure. A valve is coupled to the cuff; the valve configured to permit flow in a first axial direction and to inhibit flow in a second axial direction opposite to the first axial direction. In one arrangement, the distal end of the cuff has a non-circular cross-section with respect to the flow and the non-circular cross-section is configured to affect the performance of an adjacent valve. In another arrangement, the cuff includes an anchor moveable from a first position to a second position. In another arrangement, control wires are coupled to the cuff.

Abstract: A mono cusped patch for repairing cardiac outflow tract is disclosed in the present invention, which comprises an inner patch, an external supporting patch and a leaflet. An approximate semicircular slit is provided on the inner patch. The inferior border of the leaflet is set between the inner patch and the external supporting patch along the slit. The inner patch, the inferior border of the leaflet and the external supporting patch are stitched together along the slit edge of the inner patch with sutures. The inferior border of the leaflet is fixed between the inner patch and the external supporting patch. According to this special stitching structure, the present invention also provides a valved conduit of good performance.

Abstract: A prosthetic device is provided for treatment of an aortic valve, having a compressed state for transarterial delivery and being expandable to an expanded state for implantation. The device includes an expandable support implantable in the expanded state of the prosthetic device in an aortic annulus, and an inner envelope having an upstream portion that lines the inner surface of the support, and a downstream portion which, when the prosthetic device is in the expanded state, extends into an aorta and defines a diverging conical section having a diameter that gradually increases from an upstream end of the section to a downstream end of the section. The section is configured to produce, during systole, a non-turbulent blood flow into the aorta with pressure recovery at the downstream end of the section. Other embodiments are also described.

Abstract: There is described a prosthetic valve to be inserted into a body lumen, the valve having leaflets that are spread apart during forward flow of fluid to create an orifice, and the leaflets coming into contact with each other during reverse flow of fluid, thereby impeding the reverse flow of fluid, the valve comprising: a hollow, cylindrical stent having an inner surface and an outer surface, and having a first and a second open end; and valve means formed from a single tubular membrane, the membrane mounted to the stent, the membrane having a graft portion internally folded and bonded to itself at a plurality of points to form pouches such that the leaflets extend from the pouches, and a sleeve portion on an outer surface of the stent to secure the membrane thereto.

Abstract: Prosthetic conduits include biocompatible material formed into a generally cylindrical section and an expanded section connected to the generally cylindrical section. The conduit has a lumen extending through the generally cylindrical section and the expanded section. The biocompatible material may be tissue. The biocompatible material can include one segment or a plurality of segments joined together to form the generally cylindrical section and the expanded section. The prosthetic conduit may include a reinforcement to prevent dilation or collapse of the conduit. The reinforcement can be placed at or near the junction of a generally cylindrical section and an expanded section and/or at other locations along the conduit. The prosthetic conduit may include a prosthetic heart valve. The prosthetic conduit can include tubules to facilitate attachment of coronary arteries to the prosthetic conduit The prosthetic conduit includes two sections that are joined to form the prosthetic conduit.

Abstract: A replacement heart valve and fixture assembly for limiting longitudinal stretch during fixation of a harvested aortic root including valve leaflets. The assembly includes an inflow plug inserted into the inflow section of the aortic root and having an apertured tube or cannula extending through the valve leaflets to an outflow plug inserted into the outflow section of the aortic root. Apertures in the tube are located on either side of the valve leaflets and the tube is coupled to a fluid inlet, preferably located on the outflow plug. The outflow plug is slidable relative to the tube and is provided with an engagement mechanism such as a setscrew for fixing the location of the outflow plug relative to the tube and the inflow plug.

Abstract: A bioprosthetic heart valve is disclosed. In a first aspect of the invention, a prosthetic heart valve comprises three mammalian heart valve leaflets, each valve leaflet including a full root length of tissue, the valve leaflets being affixed to one another to define a fluid flow passage, the fluid flow through which may be governed by the valve leaflets. In a second aspect the heart valve comprises a plurality of heart valve leaflets affixed to one another to define a fluid flow passage, the fluid flow through which may be governed by the valve leaflets; and a permanent trimming guide on at least one of the plurality of valve leaflets. In yet a third aspect of the invention, a bioprosthetic heart valve comprises a plurality of assembled parts, wherein the assembled parts are sutured together by hidden and locking stitches.

Abstract: A prosthetic heart valve has leaflets made of a thin and flexible material. The side edges of adjacent leaflets are sewn together so as to form a substantially tubular valve structure having an in-flow end and an out-flow end. Each of the leaflets is adapted to flex inwardly into and out of engagement with another leaflet so as to close and open the valve in response to force by blood pressure. The leaflets are configured so that a portion of the inner face of each leaflet is in a facing relationship with a portion of the inner face of an adjacent leaflet.

Abstract: Heart valve leaflets (10) arm described that include a plurality of supports (350) within a coapting portion (20) and a substantially arcuate portion (30). The plurality of supports (350) provide the leaflet (10) with anisotropic elasticity.

Abstract: Tools can be used to assist with the implantation of heart valve prostheses, especially stentless aortic heart valve prostheses. In some embodiments, a heart valve prosthesis includes a plurality of flexible leaflets, a commissure support and a plurality of fasteners inserted into the inner surface of the commissure support and protruding from the outer surface of the commissure support. The fasteners comprise an elongated portion and a tip at an end of the elongated portion. In other embodiments, a heart valve prosthesis includes a plurality of flexible leaflets and a reinforcement secured to an inner surface of a valve commissure support. The reinforcement has an aperture. The heart valve prosthesis and fastener components can be placed into kits. The fasteners can be used to perform improved implantation procedures.

Abstract: The present invention is directed to novel, less invasive and improved methods of tissue-engineering of constructs that require an endothelial surface such as blood vessels and heart valves. The constructs of the present invention possess long-term patency. The method of the present invention is particularly suited for making small diameter vessels to replace clogged or damaged coronary blood vessels, for making trileaflet heart valve conduits to replace damaged or malformed pulmonic and aortic valves, and for other vascular structures that require an endothelial surface.

Abstract: A valve prosthesis device is disclosed suitable for implantation in body ducts. The device comprises a support stent, comprised of a deployable construction adapted to be initially crimped in a narrow configuration suitable for catheterization through the body duct to a target location and adapted to be deployed by exerting substantially radial forces from within by means of a deployment device to a deployed state in the target location, and a valve assembly comprising a flexible conduit having an inlet end and an outlet, made of pliant material attached to the support beams providing collapsible slack portions of the conduit at the outlet. The support stent is provided with a plurality of longitudinally rigid support beams of fixed length.

Abstract: A valve prosthesis device is disclosed suitable for implantation in body ducts. The device comprises a support stent, comprised of a deployable construction adapted to be initially crimped in a narrow configuration suitable for catheterization through the body duct to a target location and adapted to be deployed by exerting substantially radial forces from within by means of a deployment device to a deployed state in the target location, and a valve assembly comprising a flexible conduit having an inlet end and an outlet, made of pliant material attached to the support beams providing collapsible slack portions of the conduit at the outlet. The support stent is provided with a plurality of longitudinally rigid support beams of fixed length.

Abstract: An aortic root prosthesis for being implanted into a patient during a valve sparing surgery as a replacement for a biological aortic root segment of an ascending aorta is disclosed. The aortic root prosthesis includes a hollow, annular tube having proximal and distal ends, and an inner and outer wall. The distal end is for being attached to the ascending aorta. A plurality of sinuses are circumferentially connected to the proximal end of the tube. Each of the sinuses is adapted for being attached to the aortic wall. Each of the sinuses also includes contouring means for imparting a convex contour to an outer wall of the sinus to thereby create a space between the open leaflet and its respective sinus to prevent impact between the leaflet of the valve and the inner wall of the sinus.

Abstract: A flexible prosthetic tissue-type heart valve having commissures that are substantially decoupled from a cusp support structure. The valve includes three leaflets having arcuate cusp edges and opposed concave shaped free edges, with outwardly-directed attachment tabs therebetween. A cusp support structure in either one or more pieces attaches to the leaflet cusp edges. Three commissures are each formed partly with an axially-extending insert member to which two adjacent leaflet tabs attach. An inverted V-shaped clip maintains close contact between the adjacent leaflet tabs and provides a stress-relieving clamping action in conjunction with the insert member. The insert member attaches about its lower end to base sections of the cusp support structure, or to an intermediate sewing ring, so that the commissures may pivot about the cusp support structure. The sewing band is scalloped and enables attachment of the valve along the scalloped aortic root so as to couple the valve to the natural motion of the aorta.

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: A valve prosthesis includes a plurality of flexible leaflets and a stent having a central lumen. A slit in the stent extends from the central lumen to an outer surface. An occluding portion of the flexible leaflets extends across the central lumen and an attachment portion extends from the central lumen through the slit and forms a sewing cuff for attachment to a patient's tissue. The attachment portion forms a sewing cuff for attachment to native heart tissue.

Abstract: A polymer heart valve has a leaflet with a base geometry of a cylinder for simplicity and effective opening. A helical swept surface is added to the top of the cylinder to enhance stable coaption. The heart valve includes a plurality of flexible leaflets. Each leaflet includes a top portion and a bottom portion. The bottom portion is an axial section of a cylinder having an axis and a radius. A first section of the top portion is a surface defined by a first arc having a first radius swept along a first helix. The first arc is tangent to the axial section of the cylinder. A second section of the top portion is a surface defined by a second arc having a second radius swept along a second helix. The second arc is tangent to the axial section of the cylinder. The second helix is a left-handed helix having the same radius and axis as the cylinder.

Abstract: A bioprosthetic heart valve is disclosed. In a first aspect of the invention, a prosthetic heart valve comprises three mammalian heart valve leaflets, each valve leaflet including a full root length of tissue, the valve leaflets being affixed to one another to define a fluid flow passage, the fluid flow through which may be governed by the valve leaflets. In a second aspect the heart valve comprises a plurality of heart valve leaflets affixed to one another to define a fluid flow passage, the fluid flow through which may be governed by the valve leaflets; and a permanent trimming guide on at least one of the plurality of valve leaflets. In yet a third aspect of the invention, a bioprosthetic heart valve comprises a plurality of assembled parts, wherein the assembled parts are sutured together by hidden and locking stitches.

Abstract: A semilunar stentless valve is formed entirely of biological tissue, and has a plurality of leaflets that are joined to form an annulus and coapt to form a one-way valve. The leaflets open fully to minimize obstruction. A narrow rim of tissue is provided over commissures where the leaflets join and around a base of the valve for a serving ring. The valves can be sutured to heart tissue wall in a single suture row.

Abstract: A tubular prosthetic semilunar or atrioventricular heart valve is formed by cutting flat, flexible leaflets according to a pattern. The valve is constructed by aligning the side edges of adjacent leaflets so that the leaflet inner faces engage each other, and then suturing the leaflets together with successive stitches along a fold line adjacent the side edges. The stitches are placed successively from a proximal in-flow end of each leaflet toward a distal out-flow end. During operation, when the leaflets open and close, the leaflets fold along the fold line. Distal tabs extend beyond the distal end of each leaflet. The successive stitches terminate proximal of the distal tab portion so that no locked stitches are placed along the distal portion of the fold line. The tab portions of adjacent leaflets are folded over each other and sewn together to form commissural attachment tabs.

Abstract: The combination of a prosthetic valve and a sinus. The valve has a plurality of flexible leaflets for opening and closing the valve, each leaflet having an edge region attached to a frame of the valve and further having a free edge. The sinus has a plurality of lobes symmetrically disposed around the periphery of the sinus, and a conduit located downstream of said lobes in the direction of blood flow through the sinus. The sinus is such that the valve may be located therein with said attached edges of any one of the leaflets extending in coincidence with an upstream edge region of a respective lobe, wherein in axial section taken centrally through a lobe.

Abstract: A bioprosthetic heart valve is disclosed. In a first aspect of the invention, a prosthetic heart valve comprises three mammalian heart valve leaflets, each valve leaflet including a full root length of tissue, the valve leaflets being affixed to one another to define a fluid flow passage, the fluid flow through which may be governed by the valve leaflets. In a second aspect the heart valve comprises a plurality of heart valve leaflets affixed to one another to define a fluid flow passage, the fluid flow through which may be governed by the valve leaflets; and a permanent trimming guide on at least one of the plurality of valve leaflets. In yet a third aspect of the invention, a bioprosthetic heart valve comprises a plurality of assembled parts, wherein the assembled parts are sutured together by hidden and locking stitches.

Abstract: A stentless aortic bioprosthesis having patent, non-ligated coronary artery segments extending therefrom, and methods for surgical replacement of aortic and/or non-aortic (e.g., pulmonary) heart valves with such stentless aortic bioprosthesis. The presence of the patent, non-ligated coronary segments facilitates end to end anastomosis of the patient's native coronary arteries and/or existing coronary artery bypass grafts to the coronary segments of the bioprosthesis even when such native coronary arteries (or coronary grafts) are too short to reach the wall of the aortic segment of the bioprosthesis. The presence of such patent, non-ligated coronary segments also eliminates the need for removal of a “button” or segment of the native aorta in connection with the native coronary artery segments prior to implantation of the bioprosthesis, and is thus advantageous for patients whose ascending aorta is diseased or otherwise compromised.

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 new and unique, optimized, two-dimensional heart valve tissue pattern, valve, and a method of reconstructing a three-dimensional semilunar heart valve, or portion thereof. In one preferred embodiment, the two-dimensional valve tissue pattern, and method of the present invention, comprises a two-dimensional configuration developed and optimized by employing, in part, the anatomy of a three-dimensional human heart valve, and said two-dimensional configuration delimits a two dimensional area that corresponds to the shape of tissue to be used in the repair of at least one leaflet of a circulatory system semilunar valve, wherein the configuration delimits at least one segment, and up to all three segments, of a three segment “trefoil” shape.

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: Pre-trimmed, cryopreserved homografts and other stentless bioprosthetic heart valves having natural tissue sewing rings formed thereon. The sewing ring may be formed of strip of pericardium or other suitable tissue. Material may be captured between the natural tissue sewing ring and a sub-valvular lip formed on the valve to impart a desired size or shape to the sewing ring. In the case of cryopreserved embodiments of the invention (e.g., cryopreserved human homografts) the sewing ring is attached to the valve by way of a natural tissue suture, biological glue or other attachment component that is capable of undergoing cryopreservation without breaking, excessive weakening, or other changes that prevent it from performing its attachment function.

Abstract: A semilunar stentless valve is constructed entirely of biocompatible material, and has a plurality of leaflets that are joined to form an annulus and coapt to form a one-way valve. The leaflets open fully to minimize obstruction. A narrow rim strip overlies commissures where the leaflets join and around a base of the valve. The valve is of a conical design, flexible, easy to fit and preserves the integrity of the coronary sinuses. The valves can be implanted with a single suture row, reducing implant time significantly.