Reinforcement Materials for Prosthetic Heart Valves

Prosthetic heart valve design with improved stress isolation and leaflet durability in transcatheter valve replacement procedures. The valve has patches attached to the commissure attachment features of the stent to absorb forces during valve operation. The patches can be rigid or billowing to provide stress isolation. This reduces mechanical stresses on the leaflet tissue, especially in cobalt-chromium stents where the leaflets are coupled directly to the stent. The patches are disposed around the commissure features and the leaflets are attached to the patches instead of the stent.

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A balloon-expandable transcatheter heart valve prosthesis with improved durability and prevention of contact between the valve leaflets and stent frame during expansion. The prosthesis has a molded valve with a reinforcement member attached directly to the inflow cylinder adjacent to the leaflets. This reinforcement prevents the leaflets from hitting the frame and adds strength to the valve attachment point. Additionally, tacking stitching secures the inflow cylinder to the inner skirt to prevent bulging away from the frame during expansion.

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Prosthetic heart valve with non-uniform leaflets that have movable sections and stiffer sections. The valve has a frame that expands and contracts. The leaflets are attached to the frame and have sections that move during valve opening/closing, and stiffer sections. The movable sections allow flexible leaflet motion, while the stiffer sections provide support and prevent excessive leaflet deformation. This reduces stress concentrations and leaflet tears compared to uniform leaflets. The non-uniform leaflets are formed as single continuous pieces. The valve assembly method involves attaching the stiffer sections to the frame while the movable sections are left flexible.

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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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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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Artificial heart valve design with improved durability and fixation for percutaneous interventional implantation. The valve has a skirt unit with a downward concave defect and a leaflet unit with a matching downward protrusion. The skirt and leaflet connect with sutures through the concave/protrusion interface. This allows the skirt to anchor against the heart wall and prevent upward displacement of the leaflets. The valve also has lifting parts on the leaflets that wrap around the stent mesh to secure it. This prevents upward migration of the valve during expansion. The stent has positioning members with roots and bottoms. The roots attach to the stent and the bottoms penetrate the heart wall for anchoring. This allows the valve to expand and secure itself without separating from the stent. The lifting parts, protrusions, and roots provide additional fixation points compared

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An artificial heart valve design to improve durability and reduce replacement frequency. The valve has a reinforcing layer added to the leaflets and a suture ring around the frame. The reinforcing layer increases leaflet strength and fatigue resistance. The suture ring provides additional support and anchoring for the valve in the native annulus. The reinforcing layer is fixed to the leaflet base and extends into the suture ring. This disperses stress and prevents concentration at the leaflet base. The suture ring can extend into the aorta or left atrium for secure anchoring.

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An artificial heart valve design that aims to improve durability and reduce complications compared to conventional heart valves. The valve has multiple independently functioning incompressible valves connected together. Each valve has its own support seat and frame with attached leaflets. This modular design allows for customizable valve sizes without sacrificing fatigue performance. The multiple valves prevent compression of the native aortic valve and mitigate left ventricular outflow tract obstruction risks. It also reduces valve height compared to a single large valve.

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Transcatheter-delivered prosthetic tricuspid heart valves that can be deployed via catheters to replace sub-optimally functioning native tricuspid valves. The prosthetic valves have features to anchor them securely in the tricuspid anatomy, including flaps and arms to engage surrounding structures. This mitigates migration. The valves also have shaped leaflets and occluders to improve sealing and reduce paravalvular leakage. The deployment catheter systems have curved inner catheters to navigate the tricuspid anatomy via the vena cavas.

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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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Heart valve prosthesis made of a tubular support member with braided outer layers and leaflets attached to the inner wall. The leaflets are made by interlacing inner warp and weft threads to form layers. The leaflet edges are entangled between the outer braided layers using the inner weft threads. This allows the valve to be made entirely of woven fabric instead of separate components sewn together. The braided outer layers provide structure while the interlaced leaflets allow valve motion. The woven construction reduces fatigue and allows customized leaflet shapes.

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Prosthetic heart valve design that improves durability and prevents leaflet damage by using a skirt between the leaflets and frame. The skirt buffers the leaflets from direct contact with the frame when they close, preventing concentrations of stress that can tear or damage the leaflets. The skirt also provides reinforcement at the connection points between the skirt and frame. The skirt is sewn to the leaflet first, then to the frame, allowing the skirt to act as a cushion between the leaflet and frame. This prevents direct pulling forces on the leaflets when they close. The skirt also provides a reinforced area at the connection points between the skirt and frame, which reduces stress concentrations and makes the area flat for easier handling.

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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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A valve prosthesis design that improves closure, stability, and reduces calcification risk compared to conventional artificial heart valves. The prosthesis has a valve leaflet connector that folds around the support rod to connect the leaflet to the stent. This configuration improves leaflet closure, reduces stress concentration, and prevents calcification compared to attaching the leaflet directly to the stent.

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Implantable prosthetic heart valve design that reduces the risk of valve failure and thrombosis while allowing tissue ingrowth to anchor the valve in place. The valve has an outer skirt with a porous section to promote tissue ingrowth and a thromboresistant inner section. This allows tissue to fill gaps around the valve and prevent paravalvular leakage while preventing excessive tissue growth inside the valve. The skirt is coupled to the leaflets using bioresorbable sutures. After implantation, the sutures dissolve, allowing the skirt to separate from the leaflets. The porous skirt promotes tissue ingrowth, while the thromboresistant inner section prevents tissue intrusion into the valve flow channel.

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Prosthetic heart valve with restraining posts that prevent unwanted rotation or movement of the leaflet commissure assembly during crimping and expansion of the valve. The posts have protrusions that engage the commissure tabs to limit axial motion. The commissure tabs wrap around the posts in opposing directions. This provides a secure and self-aligning attachment of the leaflets to the frame, reducing the risk of detachment or misalignment during deployment.

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Prosthetic heart valve having increased effective flow area for a given valve size, with wireform and flexible leaflet structure modifications. The valve has an undulating wireform/stent covered in cloth with cusps and commissures. Flexible leaflets attach between the cusps and around the commissures. To increase orifice area, the leaflets extend over the cusps and/or commissures of the wireform. This allows larger leaflet coaptation area compared to traditional heart valves, increasing effective flow area for a given valve size.

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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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Improved attachment mechanisms for prosthetic heart valves that reduces stress concentrations, abrasion, and stretching of the valve leaflets compared to conventional attachment techniques. The attachments allow the leaflets to move more freely relative to the frame during expansion and contraction. One mechanism involves suturing the leaflet scalloped edges to struts perpendicular to the scallop line, allowing sliding movement. Another mechanism uses a separate flexible element to connect the scalloped edge to the frame.

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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 durable transcatheter prosthetic heart valve that avoids calcification and degradation issues of existing prosthetic valves. The valve has optimized leaflet and stent designs, woven attachment to the stent, and reinforcements. The leaflets are thermoformed from polymer material into an optimized shape. The leaflets weave through the stent frame to anchor in place. This prevents shearing forces that can damage fixed-edge valves. Fibers or other reinforcements are added to enhance valve durability.

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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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An artificial heart valve prosthesis design that improves the durability and lifespan of the valve by preventing excessive forces on the valve leaflets during operation. The valve has a unique configuration where the leaflets attach at the top to the inflow end of the stent and at the bottom to the outflow end. This allows the leaflets to open without forming an angle with the blood flow direction, reducing the radial component force on the leaflets. This avoids interference with the stent inner wall and friction that shortens valve life. The leaflets remain fixed at the top and bottom ends during closure to prevent excessive force.

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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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Prosthetic heart valve with a unique leaflet attachment method that reduces thrombus formation and eliminates the need for fabric components. The leaflets are attached to the frame using a primary suture threaded through the cusp end and a secondary suture that wraps around the struts and forms self-tightening constructs. The primary suture tracks the cusp edge shape. This allows direct attachment of the leaflets to the frame struts without intermediate fabric layers that can promote tissue ingrowth. The secondary suture forms loops and knots around the struts to secure the leaflets.

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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 heart valve prosthesis with a reinforced structure that provides stability and fixation to prevent valve migration and leakage when implanted. The prosthesis has a self-adaptive component with reinforcing features that engage the surrounding heart tissue. This component clamps onto the native valve annulus and has a bonding area that conforms to the heart tissue. The reinforcing structure on the clamping area provides rigidity to stabilize the prosthesis. The adaptive component also has a covering film that contacts the heart tissue to prevent leakage. The reinforcing features, clamping mechanism, and self-adaptive component work together to securely position and fix the prosthesis in the heart without harming the native 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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Prosthetic heart valve design with collapsible leaflets that can be delivered via a catheter. The valve has an expandable stent frame and flexible leaflets that can collapse for delivery, then re-expand once deployed in the heart. The leaflets are secured to the stent frame and have features to prevent damage from abrasion. The valve design enables less invasive delivery compared to traditional open-heart surgery.

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Highly durable synthetic flexible leaflet prosthetic heart valve design that prevents premature failure. The valve uses a composite leaflet material with an expanded fluoropolymer membrane and an elastomeric material. It also has a unique leaflet shape with an isosceles trapezoid attachment zone on the frame. The composite material and shape prevent leaflet delamination and tearing. The valve has two frames, a nested leaflet frame and an outer frame, to provide structural support and prevent leakage. It can be delivered via transcatheter or surgical methods.

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Artificial heart valve leaflet that prevents collapse and central regurgitation over time due to fatigue. The leaflet has multiple closing walls connected to a central body. Pulling tabs are attached to some of the closing walls and connect to a bracket. In the open position, the closing walls are separated and the tabs relaxed. In the closed position, all walls enclose and the tabs straighten. This allows the closing walls to be pulled by the tabs if they fatigue, preventing collapse and maintaining seal. The leaflet is used in a heart valve prosthesis where the leaflet is attached to the stent and the tabs connect to the stent bracket.

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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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An artificial heart valve leaflet and heart valve prosthesis that can fully close to avoid regurgitation and prevent large pressure differences compared to existing heart valves. The artificial leaflet has overlapping main body and closed walls that allow complete closure when the valve is closed. This prevents blood reflux and reduces pressure differences compared to incomplete closure. The overlapping walls provide a closed height that stops regurgitation and prevents large transvalvular pressure drops. The leaflet can also automatically reset to the closed position without external 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 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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Minimally invasive collapsible heart valve with a flexible support frame for easier delivery and implantation compared to conventional fixed-frame valves. The valve has a collapsible leaflet frame with alternating cusp and commissure regions. Three cusp positioners are fixed on the outflow end between the commissures. This configuration allows the valve to compress into a small diameter for delivery through a catheter. The positioners contact the aortic sinuses during implantation without blocking the coronaries. The valve expands and anchors in place. The flexible frame allows relative movement between the cusps and commissures for better durability and function compared to rigid frames.

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A prosthetic heart valve with improved durability and leaflet opening characteristics. The valve has synthetic leaflets with a central planar zone that minimizes crease formation during opening and closing. The leaflet shape also prevents intersecting creases. The planar zone has a larger area near the base than the free edge. This reduces stress concentrations compared to traditional leaflets. The valve frame has leaflet windows shaped to match the isosceles trapezoidal leaflet profile. This prevents crease intersections. The valve can be made by wrapping a composite film around a mandrel and forming the leaflets over it.

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Manufacturing prosthetic heart valves with artificial polymeric leaflets that aims at improving the manufacturability and consistency of these valves. The manufacturing involves applying a liquid polymer to the valve frame and a leaflet formation structure, partially curing the polymer in a humidity chamber, then fully curing it in another chamber. This allows the thickness of the leaflets to be precisely controlled. An identifier is marked on the valve frame to track and optimize the manufacturing process.

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Prosthetic heart valve with improved durability and function. The valve has a leaflet assembly where the leaflet can form a coaptation height of at least 0.1 mm along the free margin without pulsatile load. This prevents excessive regurgitation when the valve closes. The leaflet is attached to a supporting element along a commissure that runs a certain length parallel to the flow direction. The leaflet assembly can be made by weaving a textile structure into multiple layers, with connections between layers defining the leaflet and supporting element shapes. This provides a stable valve structure with controlled motion. The woven leaflet geometry allows for a thicker coaptation height without excess stress concentration.

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Biocompatible artificial heart valves with improved durability and reduced risk of delamination. The valves have leaflets made of coherent single layers of porous synthetic polymer membranes with elastomer present in the pores. The synthetic polymer membranes contain ultrafine fibers defining the pore structure. This design prevents delamination by sealing the pores with an elastomer, making the leaflets impermeable. The fibrous structure provides strength while the elastomer prevents separation of the membrane layers. The coherent single layers can be multiple stacked membranes bonded together.

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A method of manufacturing an implantable artificial heart valve with improved durability and less backflow compared to existing valves. The method involves weaving a seamless tubular fabric with stabilized edges to form the valve leaflets and support structure. This eliminates seams and joins compared to traditional valves. The tubular fabric has layers that can be partially inverted to create the leaflet shape. The oversized leaflet edges prevent backflow by providing a large closing surface.

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A prosthetic heart valve design with improved performance and durability compared to existing bioprosthetic valves. The valve has a unique leaflet configuration that allows shorter leaflets while maintaining good function. The leaflets are made of a film material wrapped around a support frame. The leaflets have a flat base that attaches to the frame and diverge sides. This allows shorter leaflets compared to traditional curved leaflets for better performance in a limited space. The film material can be a biocompatible polymer filled with an elastomer to provide flexibility and durability. The valve can also have a compacted size for delivery through catheters.

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Prosthetic heart valve design that reduces the risk of leakage and improves durability by ensuring proper leaflet coaptation without needing excessive elongation. The valve has a leaflet assembly where the leaflets can form a minimum coaptation height along the free margin even without pulsatile load. This is achieved by shaping the leaflets during manufacturing to impose a geometry that allows contact with the closure surface without stretching. The leaflets attach to a supporting element along a commissure that runs parallel to the flow direction. The valve can be made from woven fabrics using techniques like double weaving and thermal finishing to form the leaflets and supporting element layers.

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Prosthetic heart valves with improved durability and mechanical properties using pre-stressed reinforcement elements like fibers. The valve leaflets contain composite materials with pre-stressed fibers encapsulated between polymer layers. The fibers are pre-stressed before coupling to the layers. This provides initial tension that balances the valve's compression forces during use. The pre-stressed fibers increase durability by reducing overstretching and maintain desired leaflet elongation.

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