Abstract: The invention is directed to two minimally invasive therapeutic procedures, particularly for patients with congestive heart failure, and devices and systems for such procedures. One procedure involves providing a valved passageway through the patient's left ventricular wall at the apex of the patient's heart and advancing instruments through the valved passageway to connect the valve leaflets of the patient's heart valve, e.g. the mitral valve, in a “Bow-Tie” configuration to prevent or minimize regurgitation through the valve. The second procedure involves advancing a pacing lead and a pacing lead implanting device through a trocar in the patient's chest and implanting the pacing lead on an exposed epicardial region of the patient's heart wall. The pacing lead has a penetrating electrode which is secured within the heart wall. One or both procedures may be performed on a patient with CHF.

Abstract: The endovalve comprises an endoprosthesis deployable between a contracted state and an expanded state. The endoprosthesis defines an internal duct. The endovalve includes a valve placed in the internal duct and movable between a closed configuration shutting the duct and a release configuration leaving the duct open. The endovalve has connection means between the valve and the endoprosthesis. The connection means comprise at least one intermediate connection member connected to the endoprosthesis and including at least one region that is movable relative to the endoprosthesis. The valve is fastened to the movable region.

Abstract: A prosthetic tri-leaflet valve formed by involuting a portion of a tubular structure inside itself. The valve can be made by a method comprising providing a tubular segment in which three equidistant longitudinal incisions are made in one end of the tube creating three flaps which are involuted, i.e., folded, in toward the inside of the tube and the edges of the flaps secured to the inner wall of the tube to form leaflets. The tube can be formed of a single sheet of synthetic, organic or biological material and can be solid, woven, braided or the like. A braided configuration permits the valve to be annularly compressed and delivered to the site using a minimally invasive delivery mechanism, then expanded at the implantation site.

Abstract: Devices, systems and methods supplement, repair, or replace a native heart valve. The devices, systems, and methods employ an implant that, in use, extends adjacent a valve annulus. The implant includes a mobile neoleaflet element that occupies the space of at least a portion of one native valve leaflet. The implant mimics the one-way valve function of a native leaflet, to resist or prevent retrograde flow. The implant restores normal coaptation of the leaflets to resist retrograde flow, thereby resisting eversion and/or prolapse, which, in turn, reduces regurgitation.

Abstract: Expandable heart valves for minimally invasive valve replacement surgeries are disclosed. The valves are rolled into a first, contracted configuration for minimally invasive delivery using a catheter, and then unrolled or unfurled at the implantation site. One- and two-piece stents may be used in conjunction with a plurality of flexible leaflet-forming membranes. The stents may include an annulus section, a sinus section with the membranes attached over sinus apertures, and an outflow section. Lockout tabs and making slots secure the stents in their expanded shapes. Alignment structure ensures concentric unfurling of the stent. Anchoring elements at the stent edges or in the stent body secure the valve within the annulus. A method of manufacture includes shape setting the sheet-like stent to ensure an outward bias during deployment. The stent may also include dear tracks for engagement with a gear mechanism for deployment.

Abstract: A device (1) for treating valve failure in a patient is provided. The device has one or more engaging zones (3) for engaging the device with the annulus of the valve being treated. The device also has pre-disposition means for changing the geometry of the device to a predetermined configuration which is suitable for constricting the valve annulus. The device is compressible for percutaneous delivery to the valve. When in the predetermined configuration, the engaged device constricts the valve annulus facilitating substantial closure of leaflets of the valve.

Abstract: A prosthetic tri-leaflet valve formed by involuting a portion of a tubular structure inside itself. The valve can be made by a method comprising providing a tubular segment in which three equidistant longitudinal incisions are made in one end of the tube creating three flaps which are involuted, i.e., folded, in toward the inside of the tube and the edges of the flaps secured to the inner wall of the tube to form leaflets. The tube can be formed of a single sheet of synthetic, organic or biological material and can be solid, woven, braided or the like. A braided configuration permits the valve to be annularly compressed and delivered to the site using a minimally invasive delivery mechanism, then expanded at the implantation site.

Abstract: A heart valve constructed from a synthetic resin that is designed to be surgically implanted in the right ventricular outflow tract of the heart, comprising a plurality of flexible members, and an orifice.

Abstract: The invention is device and method for reducing regurgitation through a mitral valve. The device and method is directed to an anchor portion for engagement with the heart wall and an expandable valve portion configured for deployment between the mitral valve leaflets. The valve portion is expandable for preventing regurgitation through the mitral valve while allowing blood to circulate through the heart. The expandable valve portion may include apertures for reducing the stagnation of blood. In a preferred configuration, the device is configured to be delivered in two-stages wherein an anchor portion is first delivered and the valve structure is then coupled to the anchor portion. In yet another embodiment, the present invention provides a method of forming an anchor portion wherein a disposable jig is used to mold the anchor portion into a three-dimensional shape for conforming to a heart chamber.

Abstract: A prosthetic device including a valve-orifice attachment member attachable to a valve in a blood vessel and including a fluid inlet, and a diverging member that extends from the fluid inlet, the diverging member including a proximal end near the fluid inlet and a distal end distanced from the proximal end, wherein a distal portion of the diverging member has a larger cross-sectional area for fluid flow therethrough than a proximal portion thereof. The diverging member may have a diverging taper that causes fluid to flow therethrough with pressure recovery at the distal end thereof.

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: 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: Method and apparatus implementing and using techniques for controlling flow in a body lumen, including use of an implantable medical device. The device includes a membrane implantable in a body lumen and invertibly deformable between a first position and a second position. The membrane is invertible in response to the direction of fluid flow through the lumen and can be deformable by fluid flow in the body lumen.

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: Disclosed are methods and devices for determining valve leaflet orientation. A catheter is provided with a conformable, radiopaque target. The target is deployed within a valve, such as the mitral valve. The conformable target conforms to the coaptation axis in response to closing of the valve leaflets. That coaptation axis may then be visualized, and utilized to determine information about valve operation, or to assist in placement of devices in the vicinity of the valve.

Abstract: A venous valve prosthesis includes a hollow conduit (40) defining a central passageway through which blood may flow. Opposing, pliable leaflet members (30) are located within the conduit and move back and forth between a first, open position, whereby blood may flow through the central passageway in a first direction, and a second, closed position, whereby blood is prevented from backflowing through the central passageway in a second direction which is opposite the first direction. A hollow and generally cylindrical support member (10, 20) retains the leaflet members and is coaxially disposed within the conduit. The support member includes opposing cutaway regions (18) defining two axially extending struts (16) supporting the leaflet members. The cutaway regions, in cooperation with the struts, allow the leaflet members to collapse inwardly to the closed position.

Abstract: A sewing ring (12) has a diameter commensurate with a diameter of a removed mitral valve. Skirts (44, 46) of mesh or net material extend downward from the sewing ring and line the walls of an associated vessel (58). Basal chordae simulating structures (34, 36) in the form of elongated strips of mesh or netting, rods, or the like extend from the skirt to an underside of each of two valve leaflets (14, 16). Marginal chordae simulating structures (30, 32) extend between each leaflet and the basal chordae simulating structure. The sewing ring (12) is stitched to an open end of a vessel and inner ends of the basal chordae simulating structure are stitched or stapled (50, 52) to associated papillary musculature (54, 56). In this manner, the papillary muscles assist in controlling the timing and control of the mitral valve.

Abstract: Heart valve leaflets (10) are 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: An artificial heart valve comprising a tubular base body having sinuse(s) of Valsalva and valve cusp(s) provided inside the base body, characterized in that the base body and the valve cusps comprise a bioabsorbable polymer material.

Abstract: A method of cutting material for use in an implantable medical device employs a plotted laser cutting system. The laser cutting system is computer controlled and includes a laser combined with a motion system. The laser precisely cuts segments out of source material according to a predetermined pattern as designated by the computer. The segments are used in constructing implantable medical devices. The cutting energy of the laser is selected so that the cut edges of the segments are melted to discourage delamination or fraying, but communication of thermal energy into the segment beyond the edge is minimized to avoid damaging the segment adjacent the edge.

Abstract: A stentless atrioventricular valve intended for attaching to a circumferential valve ring and papillary muscles of a patient comprising a singular flexible membrane of tissue or synthetic biomaterial, the valve having a sewing ring, an anterior cusp and a posterior cusp, wherein the anterior cusp and said posterior cusp are an integral part of a continuum from the singular membrane without sutured commissure between remote ends of the cusps and wherein texture elements secured at edge portions of the cusps configured to extend the texture elements for connection to papillary muscles in a ventricle cavity when the sewing ring is sutured to an atrioventricular junction of a patient's heart.

Abstract: Method and apparatus implementing and using techniques for controlling flow in a body lumen, including use of an implantable medical device. The device includes a membrane implantable in a body lumen and invertibly deformable between a first position and a second position. The membrane is invertible in response to the direction of fluid flow through the lumen and can be deformable by fluid flow in the body lumen.

Abstract: A sewing ring (12) has a diameter commensurate with a diameter of a removed mitral valve. Skirts (44, 46) of mesh or net material extend downward from the sewing ring and line the walls of an associated vessel (58). Basal chordae simulating structures (34, 36) in the form of elongated strips of mesh or netting, rods, or the like extend from the skirt to an underside of each of two valve leaflets (14, 16). Marginal chordae simulating structures (30, 32) extend between each leaflet and the basal chordae simulating structure. The sewing ring (12) is stitched to an open end of a vessel and inner ends of the basal chordae simulating structure are stitched or stapled (50, 52) to associated papillary musculature (54, 56). In this manner, the papillary muscles assist in controlling the timing and control of the mitral valve.

Abstract: A valve repair device and method of repair for the mitral valve of the heart is disclosed. The valve repair device includes a leaflet portion, a muscle portion, and a plurality of chords connecting the leaflet portion to the muscle portion. The valve repair device is attached to the diseased valve by suturing the leaflet portion to the affected leaflet and suturing the muscle portion to the affected muscle. The leaflet portion and muscle portion are constructed of cloth made from expanded polytetraflouroethylene. The chords are sutures also constructed from expanded polytetraflouroethylene. The suture position for the muscle portion is determined by positioning the valve repair device adjacent to a normal marginal chord. The valve repair device may be employed to repair the anterior leaflet or posterior leaflet of the mitral valve.

Abstract: Biocompatible prostheses, specifically, biocompatible heart valves, are described having incorporated therein an effective amount of coating applied thereto to render the valve resistant to in vivo pathologic thrombus formation and in vivo pathologic mineralization. Preferably, the coating is derived from a precursor having the formula: X—Y—Z wherein X is a chemically reactive group capable, upon activation, of bonding to the surface of the heart valve; Y is either null or a relatively inert skeletal moiety resistant to cleavage in aqueous physiological fluids; and Z is a functionally active moiety or a biocompatible agent.

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: Implantable vascular devices and implantable cardiovascular devices suitable for contacting a patient's blood or bodily fluids include a polymer substrate that is at least partly coated with a diamond-like carbon coating. The diamond-like carbon coated polymer substrate can be flexible or rigid. Preferred medical devices include heart valve prostheses with leaflets or orifice rings formed from diamond-like carbon coated polymer materials. Preferred approaches for the deposition of the diamond-like carbon coating are performed at low pressures and include ion beam assisted deposition.

Abstract: A stentless bioprosthetic valve includes at least one piece of biocompatible material comprising a bi-leaflet conduit. The conduit has a distal end and a proximal end that defines a first annulus for suturing to the valve annulus of a heart. The conduit further includes first and second leaflets that mimic the anterior and posterior leaflets of the native mitral valve. The first and second leaflets extend between the proximal and distal ends. The distal end defines a second annulus at which the first and second leaflets terminate. The second annulus is for suturing to free edges of the anterior and posterior leaflets of the native mitral valve that remain intact following resection of the native mitral valve so that the native chordae tendinae continue to provide prolapse prevention and left ventricular muscle support functions in addition to maintaining the continuity between the valve annulus and the papillary muscles.

Abstract: A stentless bioprosthetic valve includes at least one piece of biocompatible material comprising a bi-leaflet conduit having a proximal end and a distal end. The proximal end defines a first annulus for suturing to the valve annulus in the heart. The conduit includes first and second leaflets that mimic the native anterior and posterior leaflets and extend between the ends of the conduit. The distal end defines a second annulus at which the first and second leaflets terminate. The conduit further includes first and second pairs of prosthetic chordae projecting from the leaflets at the second annulus. Each of the prosthetic chordae comprises a solid uninterrupted extension of the piece of biocompatible material.

Abstract: Method and apparatus implementing and using techniques for controlling flow in a body lumen, including use of an implantable medical device. The device includes a membrane implantable in a body lumen and invertably deformable between a first position and a second position. The membrane is invertible in response to the direction of fluid flow through the lumen and can be deformable by fluid flow in the body lumen.

Abstract: An improved prosthetic mitral valve is provided having advantageous hemodynamic performance, nonthrombogenicity, and durability. The valve includes a valve body having an inflow annulus and an outflow annulus. Commissural attachment locations are disposed adjacent the outflow annulus. An anterior leaflet and a posterior leaflet of the valve are shaped differently from one another. The inflow annulus preferably is scalloped so as to have a saddle-shaped periphery having a pair of relatively high portions separated by a pair of relatively low portions. The anterior high portion preferably is vertically higher than the posterior high portion.

Abstract: A support, and a method for attaching said support, for providing additional strength to existing regurgitant or prolapsed valve leaflets. The support restores an otherwise non-functioning, or poorly functioning, native valve to a functioning condition, obviating the need for a complete valve removal or replacement. The support may also be applied to a functioning valve leaflet as a prophylactic measure against future failure. The delivery method includes a delivery mechanism for attaching the support to the native valve leaflet.

Abstract: A method is disclosed for using tubular material to replace a semilunar heart valve (i.e., an aortic or pulmonary valve). To create such a replacement valve, the native valve cusps are removed from inside an aorta or pulmonary artery, and the inlet end of a tubular segment is sutured to the valve annulus. The outlet (distal) end of the tube is either “tacked” at three points distally, or sutured longitudinally along three lines; either method will allow the flaps of tissue between the suture lines to function as movable cusps. This approach generates flow patterns that reduce turbulence and closely duplicate the flow patterns of native semilunar valves. An article of manufacture is also disclosed, comprising a sterile biocompatible synthetic material which has been manufactured in tubular form, by methods such as extrusion or coating a cylindrical molding device, to avoid a need for a suture line or other seam to convert a flat sheet of material into a tubular shape.

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: A heart valve prosthesis for use as an aortic or pulmonary replacement valve, or as a mitral or tricuspid valve includes leaflets that are reinforced through the use of oriented fiber components in a laminated composite, in which the leaflets of the valve are reinforced with fiber-reinforcing materials oriented along lines of stress in the material, thus to provide a long-lived valve that provides strength at points of maximal stress that have hitherto been foci for material failure. In a preferred embodiment involving a stentless valve, the reinforcing materials are optimized in terms of the density and orientation of the fibers in the composite materials, thus to extend the life of a stentless valve, with the valve requiring no anti-coagulants as is the case with mechanical valves and exhibiting no hemolysis in which red cells are damaged by the action of mechanical valves. Longevity exceeds thirty five years in most cases, making replacement of such a valve a remote possibility.

Abstract: A method is disclosed for using tubular material to replace a semilunar heart valve (i.e., an aortic or pulmonary valve). To create such a replacement valve, the native valve cusps are removed from inside an aorta or pulmonary artery, and the inlet end of a tubular segment is sutured to the valve annulus. The outlet (distal) end of the tube is either “tacked” at three points distally, or sutured longitudinally along three lines; either method will allow the flaps of tissue between the suture lines to function as movable cusps. This approach generates flow patterns that reduce turbulence and closely duplicate the flow patterns of native semilunar valves. An article of manufacture is also disclosed, comprising a sterile biocompatible synthetic material which has been manufactured in tubular form, by methods such as extrusion or coating a cylindrical molding device, to avoid a need for a suture line or other seam to convert a flat sheet of material into a tubular shape.

Abstract: A replacement heart valve is configured to replace a native atrioventricular heart valve (mitral or tricuspid valve, positioned between an atrial chamber and a ventricular chamber). The replacement valve includes a a thin and flexible wall portion having no more than two leaflets. Two securement locations adjacent the outlet end of the valve are adapted to be attached to respective papillary muscles. The unconstrained regions between the securement locations flex inwardly into and out of engagement with each other in response to blood pressure in order to close and open the valve. The leaflets engage each other along a line of commissure.

Abstract: A biocompatible heart valve is described having incorporated therein an effective amount of applied coating to render the valve resistant to in vivo pathologic thrombus formation and resistant to in vivo pathologic calcification.

Abstract: Valved prostheses are described with crosslinked leaflets. At least one of the leaflets has a shape corresponding to a contoured surface. The leaflets are individually attached to the prostheses. Furthermore, in some embodiments, the leaflets do not comprise native leaflet tissue. Methods for forming tissue heart valve prostheses can comprise assembling a plurality of leaflets configured to open and close the valve in response to pressure differentials. Each of the plurality of leaflets is preformed individually when at least partially crosslinked in contact with a contoured surface. The individual crosslinked leaflets can be selected and matched for assembly into a valve. In general, the tissue, when it is crosslinked, has a size and shape approximately the size of a single human heart valve leaflet.

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. 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 tab portions of adjacent leaflets are folded over each other and sewn together to form commissural attachment tabs. The commissural tabs provide commissural attachment points to accommodate sutures and the like in order to secure the tab to a vessel wall, if a semilunar valve, and papillary muscles and/or chordae tendineae, if an atrioventricular valve.

Abstract: A method is disclosed for using tubular material to replace a semilunar heart valve (i.e., an aortic or pulmonary valve). To create such a replacement valve, the native valve cusps are removed from inside an aorta or pulmonary artery, and the inlet end of a tubular segment is sutured to the valve annulus. The outlet (distal) end of the tube is either “tacked” at three points distally, or sutured longitudinally along three lines; either method will allow the flaps of tissue between the suture lines to function as movable cusps. This approach generates flow patterns that reduce turbulence and closely duplicate the flow patterns of native semilunar valves. An article of manufacture is also disclosed, comprising a sterile biocompatible synthetic material which has been manufactured in tubular form, by methods such as extrusion or coating a cylindrical molding device, to avoid a need for a suture line or other seam to convert a flat sheet of material into a tubular shape.

Abstract: The invention provides a molded valve leaflet containing a molded biopolymer having fibrils and cells within the molded biopolymer, wherein the fibrils of the molded biopolymer have commisure-to-commisure alignment. The invention also provides a valve equivalent containing a plurality of molded valve leaflets that are connected to a base, wherein the molded valve leaflets include a molded biopolymer having fibrils and cells within the molded biopolymer, wherein the fibrils of the molded biopolymer have commisure-to-commisure alignment.

Abstract: A heart valve is disclosed which includes a valve body and a plurality of flexible leaflets coupled to the valve body. The plurality of leaflets can have an open position and a closed position. Each of the plurality of leaflets can comprise a belly when the plurality of leaflets are in their respective closed positions. The belly of one or more of the plurality of leaflets preferably has a continuous curvature except for two or more features.

Abstract: A tri-leaflet prosthetic cardiac valve with leaflets having an analytic shape in a selected position. The leaflets are connected to a valve body at attachment curves. The shape of the leaflet is selected from a set of geometries that can be represented mathematically. The attachment curve is selected to improve the durability of the tri-leaflet valve by moving the point of maximum loaded stress along the attachment curve away from the commissures. An inner wall of the valve body is given a non-circular shape near the attachment curve, the shape of the inner wall corresponding to the attachment curve. Also, a method of making a valve by selecting an analytic leaflet shape, selecting an attachment curve to improve durability of the valve by moving the point of maximum loaded stress along the attachment curve away from the commissures, and forming a valve body to support one or more leaflets, the valve body having a non-circular inner wall conforming to the attachment curve.

Abstract: Devices and methods are provided for securing leaflets of a cardiac valve together. The subject devices include an assembly having a fastener, means for temporarily securing the fastener to the leaflets and means for permanently securing the fastener to the leaflets and means for anchoring the fastener to the heart wall. The subject methods are characterized by temporarily grasping the leaflets of a valve together at an apposition point, assessing at least one of blood flow and pressure gradient across said valve, determining whether to permanently secure the valve leaflets at said selected apposition point based upon at least one of the measured blood flow and pressure gradient, and performing one of permanently attaching the leaflets together at the apposition site or releasing the grasped leaflets. Also included are assemblies which include a subject device and a delivery device and may include a pressure monitoring member and/or a flow monitoring member.

Abstract: A prosthetic heart valve comprises a valve body and a plurality of flexible leaflets. Each leaflet comprises an attachment end, attached to the valve body, and a free margin. The free margin comprises a center portion and two side portions, an inflow surface and an outflow surface. The outflow surface has a lower curvature than the inflow surface such that the center portion of the free margin has a first cross section which is greater than a second cross section of the side portions.

Abstract: Medical devices are described that have a releasable quantity of a stimulation compound that stimulates production of VEGF. The stimulation compound can be a polypeptide, such as hypoxia-inducible factor 1. Suitable stimulation compounds stimulate transcription of VEGF. Medical devices of particular interest include, for example, heart valve prostheses, vascular prostheses and vascular stents.

Abstract: Valved prostheses include a support structure and a plurality of flexible polymer leaflets connected to the support structure, in which the leaflets have an improved structural design. The support structure has a plurality of commissure supports and scallops between the commissure supports. Generally, the flexible polymer leaflets project away from the support structure at an attachment edge where the leaflets connect to the support structure. In particular embodiments, the leaflets at the attachment edge are at an angle from about 5 degrees to about 85 degrees relative to a plane normal to the valve axis. In some embodiments, the flexible polymer leaflets having a coaptation depth from about 0.3 times the valve radius to about 0.8 times the valve radius. In further embodiments, the flexible polymer leaflets form a valve with a valve height from about one times the valve radius to about 2 times the valve radius and have leaflet lengths at least about 1 millimeter greater than the valve radius.

Abstract: A heart valve prosthesis for use as an aortic or pulmonary replacement valve, or as a mitral or tricuspid valve includes leaflets that are reinforced through the use of oriented fiber components in a laminated composite, in which the leaflets of the valve are reinforced with fiber-reinforcing materials oriented along lines of stress in the material, thus to provide a long-lived valve that provides strength at points of maximal stress that have hitherto been foci for material failure. In a preferred embodiment involving a stentless valve, the reinforcing materials are optimized in terms of the density and orientation of the fibers in the composite materials, thus to extend the life of a stentless valve, with the valve requiring no anti-coagulants as is the case with mechanical valves and exhibiting no hemolysis in which red cells are damaged by the action of mechanical valves. Longevity exceeds thirty five years in most cases, making replacement of such a valve a remote possibility.

Abstract: A novel durable prosthetic heart valve compatible with implantation in a human natural heart valve annulus. The prosthetic heart valve comprises a tubular heart valve which in function resembles a human heart valve, but which is formed of either synthetic or biologic material. The present valve is capable of structurally complying with annular deformation during each heartbeat. Valve embodiments comprise aortic, mitral, tricuspid, and pulmonic implantable valves. Valves can be selectively impregnated with a group of biologically active substances consisting of antibiotics, bactericidal agents, anticoagulant medications, endothelial cells, genetic material, growth factors or other hormonal or biologically active substances. Use of non-thrombogenic biocompatible materials in the valve which mimics operation of a natural heart valve essentially eliminates the need for long term administration of anticoagulants.