Polymer Leaflets in Prosthetic Heart Valves

Reducing stress on leaflets of transcatheter heart valves to improve durability and longevity by allowing deflection at attachment points. The technique involves using patches, billowing patches, or flexible intermediate materials between the leaflets, cuffs, and stents to enable localized movement of the leaflets during valve operation. This reduces stress concentrations in high-stress regions like commissures, preventing leaflet damage and failure over time.

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Artificial heart valve leaflets made of polymer materials that have improved tear resistance compared to conventional polymer leaflets. The leaflets are made by coating a polyurethane layer onto a substrate of polyolefin or polysiloxane. The coating process involves dissolving the polyurethane in a solvent like N,N-dimethylacetamide and spreading it onto the substrate. This provides a composite leaflet with a hard segment (urethane) layer on a soft segment (polyolefin or polysiloxane) substrate. The composite structure improves tear resistance of the polymer leaflets. The coated leaflets also have better biocompatibility and adhesion to platelets compared to uncoated polymer leaflets.

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Collapsible prosthetic heart valves with optimized tissue thickness for better delivery and durability. The valves have leaflets made from tissue with non-uniform thickness. The thickness is greatest at the sewing edge and gradually decreases toward the free edge. This allows the valve to be compressed for delivery and then expand to full size once implanted. The thinner edges reduce the collapsible size. The thickness variation also improves durability by reducing stress concentrations. Collagen-producing cells like smooth muscle or stem cells can be incorporated in the tissue to further enhance durability.

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Transcatheter prosthetic heart valves that can be compressed for delivery via a catheter without damaging the leaflets. The valves have a skirt that fully encapsulates the leaflets both when compressed and expanded. This prevents localized forces from deforming the leaflets during compression. The skirt extends beyond the leaflet edges in the compressed state to protect them. The skirt also extends past the coaptation area in the expanded state. This configuration allows consistent loading of the valve into a compact catheter shape without risking leaflet damage.

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Artificial heart valve design with improved durability and reduced calcification compared to traditional valves. The valve has a unique fixation mechanism for the leaflets to attach to the stent. The stent has a walled groove that the leaflets pass through and connect to. This allows evenly fixing the leaflets to the stent without wrinkles. This reduces stress concentration and calcification compared to sewing the leaflets to the stent. The smooth leaflet attachment prevents tears and calcification from blood flow impact.

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Customizable prosthetic heart valves with a modular design that allows the number of leaflets to be tailored based on the native valve configuration. The valves have an annular support structure that can accommodate any number of leaflets, such as bi-leaflet, tri-leaflet, quadri-leaflet, or more. This allows a personalized number of leaflets to match the subject's native valve for improved fit and function. It also aims to reduce structural valve degeneration by avoiding excessive leaflet stresses and optimizing orifice area. The valves can be made using techniques like 3D printing, bio-printing, or xenograft tissue.

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Artificial heart valve design to improve performance and longevity compared to existing interventional valves. The valve replaces the native posterior leaflet of the mitral valve with an artificial leaflet that seals against the native anterior leaflet. This preserves the healthy anterior leaflet while replacing the failing posterior leaflet. The valve also has features like barbs on the stent to anchor it to the mitral annulus and a clamp structure to secure the artificial leaflet between the native leaflets. This reduces trauma and force on the artificial leaflet compared to compressing it into the native valve.

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Replacement heart valves made from a single molded sheet of collagen-based biomaterial that integrates the leaflets and body portion. The valves have fewer sutures than conventional valves since the leaflets and body are formed together. The valves are inserted into a stent and secured with fewer sutures compared to traditional valves. The molding process allows shaping the leaflets with concavities and variations in thickness. The valves have improved efficiency and cost compared to hand-sewn valves with separate leaflets and body pieces.

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Bionic heart valve leaflet with a three-layer structure that aims to replicate the natural heart valve leaflet's functionality and improve durability and endothelialization compared to existing synthetic valves. The leaflet has three layers: a fabric layer, a collagen layer, and a glycosaminoglycan layer. The fabric layer is made of a reticulated structure using non-degradable high-strength flexible fabric like polyester or nylon. This provides the elasticity needed for the leaflet to open and close. The collagen layer restrains leaflet movement and provides support. The glycosaminoglycan layer absorbs water and swells to buffer the leaflet movement. This bionic leaflet aims to provide elasticity, support, and buffer functions similar to the natural heart valve leaflet.

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Transcatheter heart valve replacement prosthesis with improved performance and reduced calcification compared to conventional valves. The prosthesis has an expandable frame with the valve components mounted externally on the outer surface instead of internally on the lumen side. This reduces inflammation and calcification since the frame doesn't contact the native heart tissue. The external valve attachment allows a larger outer diameter when expanded compared to the frame diameter. The external mounting also enables leaflet design with openings between posts to allow leaflet motion in the lumen.

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Prosthetic heart valve with reduced risk of thrombosis by preventing cell ingrowth onto the leaflets. The valve has an inner skirt joined to the frame that seals against the tissue. This prevents tissue from growing onto the leaflets. The skirt material is porous to allow ingrowth of tissue into the skirt itself, but not onto the leaflets. This reduces the risk of thrombosis compared to valves with exposed leaflets. The skirt can also have an airtight layer encapsulating the frame. The valve design aims to minimize contact between the valve and native tissue, reducing the risk of chronic thrombosis in low pressure applications.

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An implant to improve coaptation of an atrioventricular valve by preventing prolapse of the leaflets. The implant has a replaceable artificial leaflet, fixation to the annulus or native leaflet, and a bendable backbone connecting the artificial leaflet. The backbone restricts leaflet movement to prevent prolapse. It can be integrated into the artificial leaflet or attached to its sides. The bendable backbone allows adjustment to leaflet curvature while preventing prolapse.

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Artificial heart valve with improved coordination between leaflets to reduce regurgitation and prolong valve life. The leaflets have connecting ears on each side that have aligned holes. A flexible connector with matching holes is inserted through the holes to join the adjacent leaflets. This allows motion transmission between the leaflets for better coordination and reduces regurgitation compared to sewn leaflets with variable heights.

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A heart valve prosthesis designed to minimize regurgitation when implanted in a native mitral valve with high ellipticity. The prosthetic valve component has shaped leaflets that coapt fully when deployed in the frame to prevent central leakage. The leaflet shape is determined by a ratio of free edge length to frame inner diameter. The leaflets have slightly raised midpoints and gradual height transitions to ensure full contact when closed. This prevents regurgitation without sacrificing low profile.

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Artificial heart valve made of polymer material that overcomes some limitations of existing mechanical and biological valves. The polymer valve has leaflets that are arranged along the circumference of the valve and meet at junctions. In the natural state, the valve is not fully closed but has gaps between the leaflets. This allows blood to flow through the valve more easily compared to fully closed polymer valves. The leaflets have curved surfaces with different upper curves that converge at the junctions. This configuration reduces stress concentrations and transvalvular pressure differences during opening.

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Heart valve prosthesis with a unique leaflet arrangement and connectivity between the valve and anchor components that allows separate replacement of the valve without removing the anchor. The valve has asymmetric leaflets that close the valve orifice in different angles. The leaflets are fixed to a conical support structure. The anchor has a skirt that folds around it and connects to the valve via seams. The valve and anchor are separated by the skirt folds, allowing valve replacement without anchor removal.

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A bionic heart valve with improved durability and flexibility compared to existing prosthetic heart valves. The valve has a three-layer valve leaflet structure with an inner reinforcement layer sandwiched between an outer base layer and a wrapping layer. The reinforcement layer provides strength while the base and wrapping layers improve flexibility. This balance between strength and flexibility improves the valve's overall durability and reduces the risk of thromboembolism. The valve also has a sewing ring with a variable diameter shape to match the valve frame and facilitate suturing.

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Flexible synthetic leaflets for prosthetic heart valves that promote tissue ingrowth to reduce complications like thrombus formation. The leaflets have a composite structure with a porous synthetic membrane filled with a material that inhibits tissue growth. This inner layer is covered by an outer layer that promotes tissue ingrowth. The inner layer prevents excessive tissue growth, while the outer layer encourages normal tissue ingrowth. The composite structure allows tissue ingrowth while avoiding excessive tissue entanglement in the leaflets.

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Implantable prosthetic heart valve with a skirt that allows tissue ingrowth for anchoring and sealing while the inner surface is thromboresistant to prevent leaflet attachment. The skirt has an outer layer for tissue ingrowth and an inner layer for thromboresistance. This allows the skirt to anchor and seal in the native valve annulus while preventing excessive tissue growth inside the valve flow channel. The skirt also has bioresorbable couplers connecting it to the valve leaflets. When the couplers dissolve, the skirt separates leaving just the thromboresistant inner layer. This facilitates explant by avoiding the need for surgical cutting.

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A heart valve replacement system for treating valve diseases like pulmonary valve stenosis or insufficiency. The system has a prosthetic valve with adjustable length and bendable sections to conform to varying patient anatomies. The valve has extended leaflet edges and prongs to prevent leakage if the stent expands. The leaflets and prongs are designed to prevent contact with the stent during valve closure and opening. This allows the valve to expand to accommodate artery dilation without losing function.

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Prosthetic heart valve with flexible leaflets that are supported by a frame in a way that reduces stress and fatigue for improved durability. The valve has a cylindrical leaflet frame with commissure posts and an outer frame. The leaflets are assembled between the inner surface of the outer frame and the outer surface of the leaflet frame. The leaflets extend through slots in the commissure posts. This configuration allows the leaflets to coapt against the outer frame shoulder instead of directly against the rigid frame, reducing stress and fatigue. The leaflets also have fold-over portions that wrap around the inflow edge and are secured to the outer frame. This provides additional support and reduces stress at the attachment points. The outer frame is secured to the leaflet frame using sutures through aligned openings.

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Artificial heart valve prosthesis to improve durability and prevent calcification of the leaflets by dispersing the stress and preventing sliding. The valve has a stent with windows, leaflets with protrusions, and an intervening sheet. The windows are at the joints and the leaflet protrusions cover them. This disperses the stress at the joint-leaflet connection. The sheet covers the joint outer surface. The leaflet protrusions pass through the sheet and windows. This prevents sliding and further disperses stress.

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A synthetic valve membrane for use in prosthetic heart valves that promotes tissue ingrowth to prevent complications like thrombus formation. The membrane has a porous structure made of a stretched fluoropolymer like ePTFE, with pores filled by an elastomeric material. The membrane can also have a tissue inward growth curtain adhered to the underlying membrane base. The curtain contains pores filled with an absorbable filler material. The membrane is fixed to the valve frame to encourage tissue ingrowth across the frame and membrane interfaces.

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A replaceable heart valve designed to reduce paravalvular leaks and provide secure fixation. The valve has an expandable frame with features like circumferential curves, offsets, and compressible sections that engage surrounding tissue when expanded. The frame surrounds a valve body with three pericardial leaflets. The frame design aims to prevent blood flow around the valve by anchoring in the annulus and adjacent tissue to prevent leakage.

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Prosthetic heart valve design with improved attachment of the leaflets to the frame that reduces thrombosis risk compared to fabric-based attachment methods. The leaflets have rounded tips that are secured to the frame struts using a primary suture threaded through the tip in an in-and-out pattern. Secondary sutures surround the struts and lock the primary suture in place. This forms self-tightening structures that contract under tension to secure the leaflet tips. The lack of fabric strips between the leaflets and frame reduces tissue ingrowth and thrombosis risk.

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Assembling commissures for prosthetic heart valves using folded leaflet tabs to reduce wear and simplify assembly compared to sutures. The method involves folding the commissure tabs of adjacent leaflets into overlapping layers, with the outer edges folded inward. These folded tabs are then joined together and attached to the valve frame using separate fasteners. The folded tabs are positioned tangential to the valve circumference outside the leaflet body. This allows the leaflets to move independently during valve operation while the commissures are fixed. The folded tabs provide a secure, wear-resistant commissure connection without stitching the leaflets directly to the frame.

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A prosthetic heart valve design with improved leaflet attachment and sealing at the commissures. The leaflets are assembled with overlapping folds at the commissure tabs that are secured to an attachment member. The folded tabs are sandwiched between the valve frame and the attachment member. This avoids vertical folds that weaken the commissure. The attachment member is directly attached to the frame supports or a separate element. This improves durability and sealing compared to stitching. The overlapping folds allow secure attachment with fewer stitches.

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A prosthetic heart valve made from a composite material containing fibrous reinforcements that resist calcification and tearing. The valve leaflet includes electrospun fibers embedded in a polymer matrix. The fibers can be composed of different materials to provide tailored physical and mechanical properties. The polymer matrix can be a polyisobutylene urethane copolymer for chemical inertness.

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Prosthetic heart valves with synthetic leaflets that are heat treated to improve motion and coaptation. The leaflets are made from synthetic materials like UHMWPE, PTFE, or polyurethane. Heat setting the leaflets at temperatures between 90-170°C for 20-30 seconds biases the leaflets towards either the closed or open position. Folds or creases formed during heat setting further guide leaflet motion. This heat treatment provides a more uniform leaflet shape and motion compared to untreated synthetic leaflets.

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Prosthetic heart valves with improved leaflet motion and durability using synthetic materials. The synthetic materials are treated by heat setting at specific temperatures and times to bias the leaflets towards either the closed or open position. This helps the valve coapt and seal better. The heat treatment forms a three-dimensional geometry in the leaflets that aids in motion and coaptation. The heat setting can be done before attaching the leaflets to the valve structure.

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Foldable prosthetic heart valve made from a flexible substrate that can be folded into the final valve shape. The valve has regions defining the leaflets and outer wall when folded. The leaflet regions are arcuate segments extending from the outer to inner periphery, with adjacent leaflets meeting at seams. The wall regions are between the leaflet seams. When folded, the seams form the cylindrical outer wall and the leaflets are the flexible parts extending from the inner to outer periphery.

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Prosthetic heart valve design to improve durability and reduce wear compared to conventional prosthetic valves. The valve has a frame with interconnected struts and leaflets with undulating cusp edges. The leaflet cusps connect to the struts via skirts. The skirts have yarns that intersect at oblique angles to the strut axis. This angled orientation provides larger skirt overlap and contact with the struts, increasing durability by reducing wear compared to parallel or perpendicular yarns.

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Artificial heart valve prosthesis with improved durability and reduced stress on the valve leaflets. The valve has a stent with windows, joints, and protrusions. The leaflets have protrusions that cover the joints and windows. This disperses stress and prevents calcification at the leaflet-stent connections. Additionally, an intermediate piece covers the joints to reduce friction and wear.

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Partially reinforced textile-based artificial heart valve leaflets that have improved durability and hemodynamics compared to conventional leaflets. The valve leaflets are made by selectively enhancing specific areas like the attachment edge, joint, and free edge using jacquard weaving techniques. These areas are reinforced with higher tightness, thickness, or both to match the functional requirements. This provides targeted property enhancement without compromising overall valve flexibility. The reinforced areas reduce stress concentration and tearing compared to uniform leaflets.

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A minimally invasive prosthetic heart valve for replacing dysfunctional atrioventricular valves like the mitral valve. The valve is designed for transcatheter delivery and implantation through small incisions without open-heart surgery. The valve has a valve portion with expandable artificial leaflets, a binding portion that constricts expansion, and a connecting portion to securely attach the valve portion to the binding portion. The binding portion surrounds the natural valve annulus without interruption to prevent regurgitation. The binding portion can have annular or saddle shapes matching the natural annulus. The binding portion expands to pinch the natural valve leaflets and provide tightness. The connecting portion secures the valve portion to the binding portion.

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Prosthetic heart valves with improved durability and reduced calcification compared to traditional valves made from animal tissue. The valves have leaflets made from composites, fabrics, or meshes instead of natural tissue. The composites have a metal substrate with openings coated with a polymer. The fabrics and meshes are made from fine metal wires or braided/knitted metal structures. The valves can also have leaflets made from preserved natural tissue like pericardium that has been plastinated to replace the water and fat with a biocompatible polymer.

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Implantable prosthetic heart valves that can be delivered in a compressed state and expanded to full size after deployment to reduce the size of the delivery catheter. The valves have a stent frame with deflectable struts that can transition between contracted and expanded states. The valve body has flexible polymeric leaflets. The valve can be made using a dip casting process where the stent is dipped in wet polymer and cured, then the leaflets are formed by dipping a mold in wet polymer and curing. The stent and leaflets are assembled to complete the valve.

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Composite leaflet material for artificial heart valves that have improved durability and reduced wrinkling compared to conventional materials. The composite material is formed by combining an expanded fluoropolymer membrane with an elastomer. The elastomer fills the pores of the expanded fluoropolymer. The composite leaflets made from this material exhibit elongation while maintaining strength and then increase in stiffness beyond a certain strain. This provides flexibility during valve opening without excessive wrinkling, and resistance to tearing or failure during long-term cyclic operation.

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Replacement heart valve with improved shape to enhance function and durability compared to flat or concave valves. The replacement valve has a cylindrical support structure and multiple artificial leaflets that attach at the base and move independently. The leaflet bases are partially convex when viewed from outside the support. This shape reduces stress concentrations and prevents bulging compared to flat or concave designs. The leaflet profiles allow full opening and prevent restriction. The valve can be implanted via open heart surgery.

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Prosthetic heart valve leaflets made of composite materials with porous synthetic polymer films filled with elastomers to improve durability and biocompatibility. The leaflets have a porous synthetic polymer membrane with pores filled with an elastomer material like PMVE copolymer. This makes the membrane impermeable to prevent blood leakage. A non-elastomer PMVE copolymer coating is applied to prevent sticking. The composite structure provides flexibility, durability, and calcification resistance for long-lasting prosthetic valves.

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Heart valve prosthesis with a jacket surrounding the valve frame to improve biocompatibility and reduce thrombus formation. The jacket is made of a composite material with a porous synthetic polymer membrane and filled voids. It covers gaps and interfaces between the frame and leaflets to hide manufacturing imperfections and customize the valve for patients. The composite jacket promotes blood flow and reduces stagnation compared to solid frame surfaces.

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Artificial heart valve leaflet design to prevent regurgitation and reduce transvalvular pressure difference compared to existing artificial valves. The leaflets have overlapping main body walls and closing walls when closed, providing complete leaflet closure and avoiding regurgitation. This is achieved by having a main body wall and a separate closing wall on each leaflet that overlap when the valve is closed. This eliminates gaps between overlapping leaflets and prevents blood reflux. When the valve is open, the leaflets still overlap at the main body walls to ensure closure. The additional closing walls also help increase closure force.

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Crushable and expandable prosthetic heart valves that can be delivered minimally invasively and have improved reliability. The valves have a leaflet structure with a porous synthetic polymer membrane layer sandwiched between synthetic polymer membrane layers. The porous layer allows flow and prevents backflow. The valves also have features like loops, retaining elements, and guide protrusions to secure the leaflets during expansion. The porous membrane prevents collapse during delivery and expansion. The composite leaflet construction improves crushability, expandability, and performance reliability compared to solid leaflets.

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Artificial heart valve leaflet design to prevent regurgitation and reduce transvalvular pressure differences compared to existing artificial heart valves. The leaflets have overlapping main body and closing walls when closed to provide complete valve closure. This eliminates regurgitation and reduces the transvalvular pressure difference compared to incomplete closure. The overlapping walls also allow the leaflets to reset to the closed position after expansion. The leaflets can be made of elastic or shape memory materials to automatically close.

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Synthetic leaflet prosthetic heart valve design that improves durability and reduces stress compared to conventional synthetic leaflet valves. The valve has a coaxially arranged frame and outer frame connected by a membrane. The leaflets extend from windows defined by the inner frame. The leaflet shape is an isosceles trapezoid with diverging sides converging at a flat base. This reduces stress concentrations compared to spherical or cylindrical leaflets. The truncated base also helps prevent holes or cracks. The coaxial frames provide structural support and prevent relative motion.

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Flexible leaflet prosthetic heart valve with improved durability and manufacturing methods. The valve has a unique leaflet structure with folded sections and bridge loops connecting the leaflets. Retaining elements in the bridge loops prevent the loops from passing through post slots. This stops the leaflets from pushing against the commissure posts during closure. The folded leaflet sections are also sutured against the frame, reducing loading on the mounting ends. The valve is assembled by cutting leaflets from a stretched PTFE tube, bending the bridges into loops, placing retaining elements, sewing holding elements, and folding the leaflets.

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Artificial heart valve design that improves durability and reduces wear compared to conventional valves. The valve has leaflets that can coapt without excessive stretching. The leaflets are connected to a supporting element along a joint extending from the free edge parallel to the valve axis. This distributes stress over length instead of concentrating at the free edge. The leaflets can coapt even when not pulsating, with engagement height >0.1 mm along the edge. The valve can be made by folding, weaving, or double weaving fabric to form the leaflets and support. This allows leaflet engagement without extreme elongation.

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Artificial heart valve leaflets with improved durability and reduced wrinkling. The leaflets are made of composite materials containing a stretched fluoropolymer membrane with serpentine fibers and an elastomer. The elastomer is present in all or substantially all of the pore spaces of the fluoropolymer membrane. This composite structure allows the leaflets to bend and flex without wrinkling or folds during valve cycling. The elastomer improves leaflet elasticity and reduces closing stress. The stretched fluoropolymer membrane with serpentine fibers provides high elongation while retaining strength. The composites have reduced wrinkling compared to conventional leaflets. The elastomer-filled pores also prevent defects like holes and fissures.

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Artificial heart valve with improved durability compared to conventional designs. The valve has a leaflet that connects to the frame using an intermediate fixing member instead of directly suturing the leaflet to the frame. This prevents tearing and damage to the leaflet sutures as the valve opens and closes. The fixing member has a receiving groove that holds the leaflet edge, allowing the leaflet to move freely. The fixing member is also sutured to the frame separately. This reduces stress and strain on the leaflet-frame junction compared to direct suturing.

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Artificial heart valve made using a substrate that promotes tissue ingrowth to form functional valve leaflets. The substrate has a base with recesses covered by a removable lid. Tissue invades through ports between the recesses and base to form leaflets connected to the outer tube. This allows the leaflets to be supported by the tube and deform radially under pressure. The substrate is placed in a tissue environment to form the leaflets, then the base is removed leaving the ingrown tissue leaflets attached to the tube.

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