Hybrid Prosthetic Heart Valves

Improving features of implantable medical devices, such as prosthetic heart valves, for implantation, function, and explant. The valves have skirts with inner thromboresistant sections and outer tissue ingrowth-allowing sections. The inner section prevents thrombosis, while the outer section promotes tissue attachment. The skirt is also bioresorbable and can be separated during implant removal. The valves can also have bioresorbable couplers between the skirt and leaflets. This allows tissue growth while the valve is implanted,and then the couplers dissolve for easy explant. The skirt can also be porous for tissue ingrowth.

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Self-expanding replacement mitral valve that can be delivered minimally invasively and has improved flexibility for implantation in the complex mitral valve anatomy. The valve has a separate ventricular anchor, central portion, and atrial anchor that expand radially. The atrial anchor has an annular frame with apertures aligned with central portion apertures. Couplers extend through the aligned apertures and are plastically deformed to secure the central portion and frame. This allows separate expansion and flexibility of the ventricular and atrial anchors while maintaining valve integrity. The valve also has struts connecting the central portion to the leaflets.

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Prosthetic heart valve for replacement of a native valve like the aortic valve, designed for transcatheter implantation. The valve has a unique frame shape that engages both the native valve inflow and outflow surfaces. The frame has an inner frame that defines the valve lumen and an outer frame around it. The inner frame struts form double strut pairs converging at proximal junctions. The outer frame struts form multiple strut pairs converging at proximal junctions. These junctions align circumferentially and engage the native valve leaflets. The inner frame engages the inflow surface and the outer frame engages the outflow surface. This provides better anchoring compared to a single frame design.

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A low-profile prosthetic mitral valve replacement device that can be delivered transcatheterly and anchored to the native mitral annulus without enlarging the implant size. The device has a partially elliptical upper stent portion for annulus anchoring and a smaller fish mouth-shaped lower portion with a mobile prosthetic leaflet. The lower portion is suspended near the native valve coaptation line. The leaflet coapts with the native anterior leaflet during systole, then moves in diastole to allow flow. Channels prevent leakage between posterior leaflets. The lower portion's smaller size allows crimping for delivery.

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Prosthetic heart valve design that allows the valve to self-expand to its functional size after implantation without requiring a balloon or other external expansion method. The valve has leaflets with a height difference between the attachment edge and the free edge. The upper material portion connecting the free edge provides relaxation that allows the leaflet edges to extend radially when the commissures form, avoiding gaps and ensuring apposition. The height difference also allows the free edges to separate during diastole. This self-expanding design enables radial compression for delivery and reduces pressure gradients compared to crimped valves.

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Collapsible transcatheter heart valve with a single flexible leaflet made of biocompatible tissue like pericardium. The leaflet has a body that can flex between open and closed positions, with a separate extension integral to the body. This allows the leaflet to move independently from the frame during valve closure, reducing stress concentrations compared to fixed leaflets. The flexible leaflet design provides improved durability for single leaflet valves by distributing closing forces over the leaflet area instead of concentrating them on a single point.

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Valve prosthesis for heart replacement that adapts to various anatomical structures to improve fit and reduce leakage. The prosthesis has a detachable valve annulus that can be customized to match the patient's native annulus shape. The valve frame connects to the annulus using a snap-fit mechanism. This allows the annulus to be 3D printed separately based on imaging of the patient's native annulus for a better fit. The detachable connection allows optimal annulus shape without compromising valve performance.

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Prosthetic heart valves with reinforced leaflets for improved durability during implantation and expansion. The leaflets have a cusp edge reinforcement structure attached along the edge. This reinforcement includes reinforcing members on opposing major surfaces of the leaflet. The leaflets are sewn to the frame at the cusp edge using the reinforcing members. This prevents excessive stretching and deformation of the leaflets during implantation and expansion. The reinforced leaflets provide enhanced structural integrity compared to traditional un-reinforced leaflets.

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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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Prosthetic heart valve assembly that can transition between forward and reverse flow configurations to reduce pressure and afterload during heart contractions. The assembly has a movable docking device with a fixed valve between inflow and outflow ends. The valve can slide within the docking device during flow cycles. This allows multiple flow pathways through the assembly during reverse flow, reducing pressure compared to a fixed valve.

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Prosthetic heart valve design with reduced contact between the valve supports and the balloon of a delivery catheter when compressing the valve for implantation. The valve has a collapsible frame with angled supports. The leaflets have connecting skirts with central portions and base portions. The skirts attach the leaflet edges to the frame supports. This configuration allows the leaflet cusps to fold into the frame instead of directly contacting the balloon when compressing the valve for delivery. An external sealing member around the frame further isolates the leaflet edges from the balloon.

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A simplified hybrid prosthetic heart valve design for easier assembly and reduced labor hours, that facilitates valve-in-valve deployment and reduces manufacturing complexity. The valve has a expandable frame at the inflow end that can be compressed for delivery. The expandable frame can plastically expand when subjected to sufficient force, allowing post-implant expansion. This avoids the need for an overall expandable frame. The inflow stent provides anchoring while allowing valve-in-valve. The outflow stent is compressible to reduce size during delivery.

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A prosthetic heart valve design with improved sealing and lower profile for minimally invasive implantation. The valve has a collapsible frame with a valve structure inside. The leaflets have features like folded tabs and connecting skirts to allow blood flow between the frame and unattached edges. A sealing member covers the frame openings between leaflets but leaves gaps facing the outflow surfaces to allow retrograde flow. This prevents leakage while reducing profile during crimping.

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Prosthetic heart valve with improved commissural support to prevent leaflet wear and failure. The valve has a collapsible frame with angled commissure attachment struts that allow the leaflets to open without contacting the frame. This prevents rubbing and wear on the leaflet edges. The struts deflect inward during initial implantation and then stay in position during valve cycles. The spaced inner commissures and deflecting struts prevent leaflet-frame contact during operation.

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A prosthetic tricuspid valve that can be implanted in a native tricuspid valve without direct attachment to the annulus or chordae tendineae. The valve has asymmetrical support structures that grasp the native leaflets and allow the prosthetic valve to move with the native valve during the cardiac cycle. This biodynamic design preserves native annulus motion and prevents issues like heart block. The valve has leaflets, covers, and arms that attach to the native leaflets and surround the native annulus.

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Prosthetic heart valves with improved sealing and anchoring for minimally invasive implantation. The valves have features like anchors that extend over and couple to the native valve leaflets, sealing prongs that reduce flow around the valve, and adjustable outer diameters for better conformance to non-circular annuli. The valves also have methods like retaining native leaflets between outer and inner anchors, sealing against recesses, and extending anchors over distal tips. This aims to prevent paravalvular leakage and provide secure and atraumatic implantation in irregular anatomy.

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Implanting a prosthetic valve within a heart valve. The implant includes a plurality of prosthetic valve leaflets, a valve frame configured to support the plurality of prosthetic valve leaflets, and a plurality of elongate anchor arms each having a first end portion coupled to the valve frame and each configured to extend radially outward from the valve frame to a second end portion that is configured to anchor to an interior surface of the heart valve.

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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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A biomechanically anchored artificial tricuspid valve that improves function and reduces complications compared to conventional replacement valves. The valve is designed to biomechanically secure to the native tricuspid valve leaflets instead of attaching to the annulus. This allows the prosthetic valve to move axially within the native valve during the cardiac cycle. The anchoring reduces motion differences compared to the native valve, avoiding conduction blockages. The valve also has asymmetric support structures, pleated atrium covers, and leaflets that contact each other to prevent leakage. The biomechanical anchoring reduces blood flow obstruction and thrombus formation compared to rigidly fixing the prosthetic valve to the annulus.

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Mitral valve replacement prosthesis that reduces the risk of displacement and obstruction compared to conventional designs. The prosthesis has a separate anchor that attaches to the valve frame and extends outward. This allows the valve frame to be shorter and not extend into the left ventricle as much, preventing obstruction. The anchor also secures the valve in place to prevent displacement. The prosthesis can be delivered using a steerable sheath and guide wire for accurate anchor placement.

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Prosthetic heart valve with flexible leaflets that are mechanically secured to the valve frame to prevent separation during use. The valve has a frame with projections extending through leaflet apertures in the leaflets. This retention mechanism prevents leaflet detachment compared to suturing or gluing. The projections are spaced apart from the leaflet edges and bases. The leaflets have matching apertures for the projections. The projections can be formed integrally with the frame or attached. This provides secure leaflet retention without adhesives or sutures.

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Prosthetic heart valves for transcatheter implantation with improved performance and durability. The valves have a unique leaflet shape to reduce stress and improve function, and protective covering members attached to the stent frame to prevent contact with the leaflets. The leaflets have a three-part shape with planar regions connected by a concave region. This shape reduces stress and improves function compared to conventional leaflets. The covering members on the stent frame prevent direct contact between the leaflets and frame during expansion, which can degrade the leaflet material.

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A delivery system for implanting a heart valve device at a native heart valve that allows easier delivery and improved engagement of the device with native leaflets to reduce paravalvular leakage. The system has a detachable support that attaches during delivery and separates after implantation. The support has components like rails, catheters, and locks that engage during delivery and detach during implantation. An actuator activates the locks to secure the valve and detach the delivery components. This allows the valve to be delivered through smaller vessels and then expand and lock in place.

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A prosthetic heart valve design with multiple leaflets that grow with the patient's heart and avoids commissure failure like current valves. The valve has multiple aligned tubular members that are sutured together longitudinally and horizontally to form the leaflets. This prevents the inner tubes from collapsing like in prior designs. The commissures are defined by fixed attachment of the exterior surfaces of adjacent tubes along the longitudinal axis. This allows the valve to grow as the patient's heart expands, unlike fixed-tube designs. The valve can be made by growing collagenous matrix tubes in vitro from cells and then decellularizing them for use as allografts.

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A holder for a hybrid surgical prosthetic heart valve that enables quick release and deployment of the valve during surgery, reducing the time the heart is stopped. The holder has sutures that constrict an expandable anchoring stent on the valve inflow end. Severing the sutures allows the stent to expand to its natural size and detach the holder.

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An implantable prosthetic heart valve with a unique attachment method that allows the flexible leaflets to be securely attached to the frame in a crimped state without requiring excess slack to accommodate expansion. The leaflets are sandwiched between arcs of the frame, wrapped with a cloth, and sewn together. This creates a robust attachment point that maintains constant distance as the valve deploys. The cloth wraps around the frame posts to secure the leaflets. This allows a compact crimped size for delivery, avoids tearing during expansion, and prevents deformation of the leaflets.

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Composite skirt for a prosthetic heart valve with optimized regions to reduce regurgitation and improve function. The skirt has separate sections for the inflow, transition, and outflow segments of the stent. The inflow section has elasticity for adaptation. The transition and outflow sections have skirts with lower permeability materials to reduce regurgitation. When the permeability of the transition skirt is higher than the outflow skirt, regurgitation is further reduced. This tailored skirt design allows matching skirt parameters to the stent regions for better primary tissue integration and reduced regurgitation.

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A replacement heart valve that can be compacted for delivery and then expanded in place during minimally invasive procedures. The valve has an expandable frame with anchors to engage the native valve annulus. The valve body is attached to the frame and has larger diameter at the downstream end compared to the upstream end. This configuration allows the valve to expand radially while compressing longitudinally during delivery. The anchor tips positioning and differential frame diameters enable controlled placement and secure fixation once expanded.

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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 assembly for minimally invasive replacement of native valves like mitral or tricuspid valves. The assembly has a compressible anchor with a clamping part that can grasp part of the native valve leaflets during delivery. The anchor is released first to position it, then the compressed prosthetic valve is released to expand and engage the anchor. This prevents left ventricular outflow tract obstruction by clamping the anchor leaflets. The compressible design allows delivery through catheters and reduces implant size.

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Artificial heart valve system with improved anchoring mechanism for interventional valves that can be delivered through catheters for less invasive valve replacement. The valve has a holder with an anchoring part that extends toward the atrium. The delivery system has a section that engages the anchoring part and opens it outward when acted upon. This allows the valve to expand and evert more fully when released, making it easier to grasp and anchor the natural valve leaflets for secure implantation. The delivery system also has a head fixing frame that accommodates the anchoring part section.

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Expandable prosthetic heart valve with features to prevent paravalvular leakage and improve longevity. The valve has an expandable frame, a valve body, and an annular skirt. The skirt surrounds the frame exterior to block flow around the valve. The frame has anchors to secure the valve in place. The valve can be delivered through minimally invasive procedures. The skirt and anchors prevent paravalvular leakage. The skirt with holes allows some regurgitation initially. The anchors atraumatically fixate the valve. The frame design reduces thrombosis. The skirt and frame features enable valve-in-valve replacement.

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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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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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Heart valve replacement prosthesis with improved alignment properties for minimally invasive implantation. The prosthesis has a stent with annulus and commissure alignment features. The annulus alignment means engage the native valve annulus and the commissure alignment means engage the native valve commissures. This provides better alignment and seating of the prosthesis without interfering with the heart structure. The alignment features also prevent blockage of coronary artery ostia. The prosthesis ratio of annulus to commissure distance to annulus diameter is 1.01-1.14, mimicking the native valve. The cell distribution in the inflow and outflow ends further mimics the native valve. The alignment features, cell distribution, and prosthesis dimensions improve prosthesis alignment, durability, and reduce long-term side effects compared to prior art prostheses.

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Prosthetic heart valve with an airtight layer to reduce tissue ingrowth and thrombosis. The valve has an annular frame, a valve structure with leaflets, and an inner skirt enclosed by an airtight layer. The airtight layer prevents cells from the patient's tissue from growing into the valve structure. This reduces the risk of tissue ingrowth and thrombosis compared to conventional valves with porous skirts. The valve can also have features like curved leaflet tips, collapsible frames, and low pressure optimization.

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A durable transcatheter prosthetic heart valve with optimized leaflet and stent design, fiber reinforcement, and shock absorbers to improve longevity and reduce failure mechanisms compared to conventional bioprosthetic valves. The valve has shaped leaflets that weave through the stent frame to enhance durability. Reinforcement components are coupled to the frame and/or leaflets to enhance performance. The leaflets are thermoformed into optimized shapes based on stress-free state studies. The stent design is optimized to minimize stress concentrations at the leaflet-frame interface. Fiber reinforcement is added to the leaflets and frame to strengthen them. Shock absorbers are placed between the leaflets to reduce stresses during closure. These optimizations aim to reduce calcification, degeneration, and structural damage compared to conventional valves.

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Prosthetic heart valves and other prosthetic devices with anchoring frames to secure them in place when implanted in native tissue without calcification or stenosis. The anchoring frames have tissue engaging elements that contact native tissue to resist displacement. This allows implanting the prosthetic devices in non-stenotic native valves where conventional devices lack anchoring. The anchoring frames can be added to existing prosthetic devices without major redesign. The frames can expand with the device and be delivered in a compressed state. They can also have sutures to reduce paravalvular leakage.

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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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Biodynamic prosthetic tricuspid valve that can replace a faulty tricuspid valve while preserving the natural motion of the native valve. The prosthetic valve has support structures with arms that secure to the native valve leaflets instead of directly attaching to the annulus. This allows the prosthetic valve to stabilize in the native annulus and respond to pressure changes without restricting leaflet motion. The biodynamic fixation prevents conduction blockage near the native valve. The valve also has a central channel, leaflet elements, and covers. The central channel defines a path for blood flow. The leaflet elements attach inside the channel to control flow. The covers are in the channel and arms to protect components. The biodynamic fixation allows the prosthetic valve to match the native valve's motion during the cardiac cycle.

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A prosthetic tricuspid valve that biodynamically fixes to the native valve without direct attachment to preserve native motion. The prosthetic valve has an asymmetric central passageway support structure that grasps and stabilizes the native leaflets. Leaflets inside the passageway control blood flow. Cover segments enclose arm sections to reduce leakage. The asymmetry allows motion with pressure differentials. This allows the valve to move with the native annulus without direct attachment.

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Self-expanding mitral and tricuspid valve prosthesis to replace diseased native heart valves. The prosthesis has a main body implanted at the annulus, artificial leaflets attached to the body, and chordae tendineae connecting the leaflets. The chordae limit leaflet motion and prevent prolapse/evertion. The leaflets have connecting portions instead of direct attachment. This reduces leaflet stress and improves durability compared to direct attachment. The connecting portions have holes for the chordae to pass through. The holes distribute force evenly.

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Collapsible prosthetic mitral valve design with controlled deployment for minimally invasive implantation. The valve has an outer frame that engages the native valve tissue, an inner frame inside the outer frame, a prosthetic valve assembly inside the inner frame, and a constraining band around the inner frame. During delivery, the outer frame is collapsed inside a sheath. The inner frame is deployed first to anchor the valve, then the outer frame expands. The constraining band prevents overexpansion of the inner frame. This allows controlled expression of the valve components from the delivery device to avoid damaging the native valve or surrounding tissue.

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Percutaneous prosthetic valve replacement system for minimally invasive heart valve replacement that can be delivered through a catheter. The prosthetic valve has a expandable support with arms that engage the native valve annulus and leaflets to secure the prosthesis in place. The arms extend around the leaflet edges, between the chordae tendineae, and engage the subannular surface. This provides anchoring without compressing the native annulus. The expandable support has an interior to house the prosthetic valve. The arms have variable lengths and angles to match the native anatomy. The device can also have membranes to seal commissural regions.

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Artificial heart valve design to avoid obstructing blood flow and maintain natural channels when implanted in the mitral valve. The valve has a unique configuration with a central hub surrounded by multiple leaflets that open and close like a natural mitral valve. The hub has a concave shape that conforms to the mitral valve anatomy and allows blood to flow smoothly around it. This prevents obstruction and turbulence compared to conventional valves that can obstruct natural flow paths. The valve is implanted through minimally invasive procedures to repair mitral regurgitation without open heart surgery.

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A crushable and expandable prosthetic heart valve with improved reliability and a delivery system for implantation. The valve has a frame and a leaflet structure that can expand and contract. The leaflet has a composite material with a porous synthetic polymer membrane layer and an elastomer layer. This composite leaflet design provides better crushability and expandability compared to traditional leaflets. The delivery system has features to prevent the leaflet from collapsing during delivery and deployment. The valve frame has projections that engage loops on the leaflet tabs to secure the leaflet during delivery. The leaflet also has projections that slide onto the frame to further secure it. This prevents the leaflet from sliding off the frame during delivery.

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Artificial heart valve designed to prevent paravalvular leakage by tightly sealing against the native valve annulus. The valve has a blocking mechanism that extends outward from the stent to fill recesses in the annulus. It consists of telescopic units that can contract or expand to conform to the annulus shape. This allows the valve to adapt to different annulus sizes and positions. The telescopic units fill the annulus recesses to create a tight seal between the valve and annulus, preventing leakage.

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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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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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Flexible leaflet prosthetic heart valve that can be delivered through a catheter into a native valve, then expanded inside the native valve to replace it. The valve has a two-part design with a nested frame configuration for delivery. The leaflet frame is smaller than the anchor frame and offset when delivered. Inside the native valve, the leaflet frame nests inside the anchor frame to expand the valve. This reduces downstream occlusion compared to a single-piece prosthetic valve. The nesting frames allow a smaller delivery profile while still expanding fully inside the native valve.

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