Flow Control in Prosthetic Heart Valves

An artificial heart valve that reduces paravalvular leakage, the gap between the valve and native tissue, after implantation. The valve has a stent, leaflet assembly, inner skirt, and sealing area. The sealing area adapts to the shape and size of the gap and seals it using pockets that can accommodate refluxed blood. This prevents leakage by sealing around the stent instead of compressing tissue. The skirt seals the leaflets to the stent, and the sealing area expands and deforms to adaptively seal the gap.

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Artificial heart valve design with features to prevent leaflet deformation under backpressure and improve durability. The valve has leaflets attached to a frame that can move between open and closed configurations. Support members are attached to the leaflets and move with them. When the valve is closed under backpressure, the support members prevent leaflet deformation by transferring force to the frame instead. This prevents buckling and displacement. The leaflets can be formed separately as flat sheets then attached to the frame.

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Compressible prosthetic heart valve with improved function and reduced risk of thrombus formation. The valve has a sealing feature that partially extends between the inner and outer frames, allowing backpressure to act on it during ventricular systole instead of the valve leaflets. This reduces forces on the inner frame and coupling arms. The sealing feature also prevents blood stagnation and clot formation in partially confined pockets between the frames. An embolism retention member with lower permeability than the sealing feature can be added to fully confine clots.

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A prosthetic valve for replacing a tricuspid valve that reduces regurgitation by using a diaphragm that collapses during forward flow and expands to seal the valve during reverse flow. The diaphragm is supported by a flexible frame that conforms to the annulus shape. The diaphragm divides the flow channel into disconnected chambers. The frame flexes during the cardiac cycle. The diaphragm fills with blood when flow is blocked, preventing regurgitation, and returns during diastole. The flexible frame shape matches the annulus. The delivery system has a guide wire with a knurl and threaded tube to prevent disconnection.

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Heart valve prosthesis that reduces paravalvular leakage after implantation compared to conventional valves. The prosthesis has an inflatable bag on the atrial side that expands when the heart contracts. Blood rushes into the bag through an opening in the coating, filling gaps between the valve and annular tissue. This adaptively fills the gaps and reduces leakage. The bag is formed by redundant covering on the atrial segment of the valve frame. The bag expands when the heart contracts, utilizing blood flow characteristics to fill gaps and reduce leakage.

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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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Prosthetic heart valve with a support structure that actively assists in opening and closing the valve leaflets. The support structure has resilient protrusions coupled to the leaflets and a base. When the transvalvular pressure becomes less negative, the protrusions begin to move from a closed position to an open position, aiding in valve opening. This provides active leaflet assistance compared to passive support structures. The resilient protrusions help the leaflets open and close without needing high leaflet stiffness.

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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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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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A prosthetic heart valve designed specifically for the tricuspid valve to address the unique challenges of treating tricuspid regurgitation. The valve is biomechanically secured to the native tricuspid valve leaflets instead of directly attaching to the annulus or chords. This allows the valve to pivot within the native valve annulus in response to pressure changes. The valve has asymmetric leaflets, expanded armsets, and covers to reduce leakage. The expanded armsets have asymmetric lengths to match the native valve leaflets. The covers surround the arms and contact the native valve leaflets. The valve maintains axial stability within the native annulus without attaching to it.

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Prosthetic heart valve design to mitigate blood stagnation and reduce fluttering of the valve flaps. The valve has additional openings in the inner wall through which blood can be redirected away from the main flow path. This mitigates stagnation points and promotes laminar flow. The openings are positioned and sized to prevent turbulence and maintain low shear stress. The redirected flow flushes the valve walls. The valve also has sub-passages to further control flow and reduce the volumetric flow rate. Tethers can couple the flaps to prevent excessive fluttering.

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A prosthetic heart valve for treating mitral regurgitation when the native mitral valve leaflets still allow backflow during systole despite being clipped together. The prosthetic valve has a body with inlet and outlet ports, flaps, and a flow control device between the flaps. It is implanted in the flow control portion between the clipped mitral leaflets. The prosthetic valve allows blood flow during diastole and prevents regurgitation during systole. The body seals with the leaflets and resists displacement. The flow control device replaces the native leaflets' function.

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Artificial heart valve with reduced paravalvular leakage by using an outer skirt that compresses against the native valve annulus to seal gaps, and an inner skirt that prevents fluid leakage between the outer skirt and the valve support. The outer skirt has higher elasticity than the inner skirt. This allows the outer skirt to deform and better conform to the annulus shape for sealing, while the inner skirt maintains contact with the valve support. The skirts surround the valve frame and are connected to enclose a space filled with a fluid. When implanted, the outer skirt first contacts the annulus and compresses the fluid between it and the inner skirt to seal gaps. This reduces paravalvular leakage compared to just filling the gap with a single skirt.

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A prosthetic mitral valve with angled leaflets that directs blood flow towards the posterior wall of the left ventricle. The valve has an expandable frame, a covering, and leaflets angled relative to the longitudinal axis. This design allows the prosthetic valve to be implanted in the native mitral valve and expand into engagement. The angled leaflets direct blood flow parallel to the axis towards the posterior wall of the left ventricle, which may help maintain more natural flow patterns compared to parallel flow.

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Transcatheter prosthetic heart valves that can be delivered through small diameter catheters and deployed orthogonally to the long axis of the catheter. The valve has a compressible tubular frame with an inner flow control component that permits flow in one direction. The valve is deployed by releasing it from the catheter, transitioning from a compressed to expanded configuration. It can be delivered to desired locations in the body via catheters with reduced profile compared to traditional valves.

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A monoleaflet prosthetic heart valve designed to reduce thrombosis and hydraulic resistance compared to existing prosthetic valves. The valve has a specialized leaflet shape, size, and orientation. The leaflet has a flat side, a tapered side with a central groove, and a cylindrical surface. The groove, leaflet thickness, and angular motion are finely tuned dimensions to optimize flow and thrombosis. The leaflet is housed by struts that support it while restricting motion. The struts, valve size, and leaflet placement are adjusted based on the optimized dimensions.

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Securing, tensioning, and re-tensioning a tether of a prosthetic heart valve to improve positioning and adjustability. The tether connects the valve to an anchor outside the heart. After initial tensioning, a collapsible tube with a wire leader is used to access and secure the tether end beyond the anchor. This allows tightening the tether without removing the excess length. The tube can be tensioned proximally to tighten the tether. This enables adjusting valve position post-surgery without re-capturing the tether. The tube can also be used to replace the anchor without losing tension.

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An implantable valve prosthesis for preventing blood reflux from the heart chambers into veins like pulmonary or caval veins. The valve has a collapsible tube with a closed end that protrudes beyond the stent's opening. A stabilization wire supports the tube end to prevent collapse. The valve opens in the neutral state but closes when pressurized. Two valves can be connected to span multiple veins. This allows implanting a single valve in veins connecting to both atria, like pulmonary veins or caval veins, to prevent backflow into the veins during systole.

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Prosthetic heart valve with modified structure to reduce pressure drop across the valve. The valve has a support frame with undulating inflow cusps and outflow commissure posts that angle outward to widen the outflow orifice. The flexible leaflets attach to the cusps and coapt in the middle. When the valve opens, the leaflets spread outward to provide an outflow orifice area at least as large as the maximum flow orifice area. This prevents flow restriction. The angled commissures provide a larger exit orifice than entrance orifice to induce laminar flow and reduce pressure drop.

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Heart valve design to mitigate blood clot formation and reduce fluttering of the valve leaflets. The valve has openings in the inner surface through which blood is redirected from the main flow path during valve opening. This prevents stagnation and promotes laminar flow. The openings are positioned and sized to reduce flow rate below a threshold. This prevents turbulence and fluttering. The valve housing and leaflets also have shapes to reduce shear stress below thresholds for platelet activation and hemolysis.

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Artificial heart valve design for transcatheter replacement that aims to provide improved fixation and prevention of complications compared to existing devices. The valve has a multi-layer mesh stent, discs at the outflow end, valve leaflets inside, and a suture membrane. The leaflets have protrusions that fit into suture holes and are sequentially sutured to the stent. This provides strong radial support and fixation to the native valve, reducing paravalvular leakage and avoiding issues like atrioventricular block. The valve is delivered using compression to expand it after implantation.

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Prosthetic heart valve with adjustable commissure supports to enable proper coaptation of leaflets over a wide range of expansion diameters. The valve has an adjustable frame with commissure supports that have adjustable arms. The leaflets are attached to the adjustable arms. Twisting or rotating the adjustable arms changes the tension of the attached leaflets. This allows adjusting the leaflet coaptation force to match the expanded valve diameter. A delivery assembly with adjustment tools enables adjusting the commissure supports during implantation. The adjustable commissure supports prevent overstretching or loosening of the leaflets at extreme expansion diameters.

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A blood flow controlling apparatus for treating leaking heart valves without open heart surgery. The device has a valve that can extend into the heart to block regurgitation, and an anchoring element to fix it in place. The valve contacts tissue when inserted but releases when exposed to blood flow. This allows implantation through small puncture sites by separating the valve and anchoring diameters. The valve extends transversely to engage the valve leaflets or vessel wall, preventing backflow. The anchoring element secures the position. The device can be delivered using a catheter and implanted without stopping the heart.

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Prosthetic heart valves that can replace native valves without a support frame to reduce disruption of blood flow. The valves have conical shapes with multiple flow modulation regions. They are made of collagenous tissue like pericardium to promote tissue growth and integration. The valves expand when blood pressure opens them. When implanted, they provide blood flow rates and dynamics similar to natural valves. The conical shape reduces disruption of outflow from the left ventricle. The valves can contain biologically active agents to stimulate tissue growth or suppress immune response.

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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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A prosthetic heart valve that gradually reduces regurgitation over time to allow the body to adapt to the new valve. The valve has features like temporary openings, degradable components, and growing tissue that restrict flow after deployment. This prevents sudden changes in afterload/preload that could cause heart failure. The valve starts with regurgitation then gradually seals off the temporary openings as tissue grows. Some components degrade over time as well. This allows the body to adapt to the new valve's functionality instead of having an instant change.

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Hybrid heart valve that can expand after implantation to receive an expandable prosthetic valve inside it. The hybrid valve has a fixed, non-expandable valve component with leaflets and commissure posts to ensure blood flow. But it also has a separate expandable frame at the inflow end that can plastically expand when a force exceeding normal physiological levels is applied. This allows the hybrid valve to expand to accommodate an expandable prosthetic valve implanted inside.

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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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Prosthetic heart valve design for transcatheter delivery that prevents misorientation during implantation. The valve has a unique wire mesh flange shape with a tubular inner frame and tapered hooks. The mesh is radially collapsible for catheter delivery. In the expanded state, the tubular frame allows the mesh to conform to any annulus orientation. The tapered hooks capture native leaflets. The tapered hook shape allows flexibility in orientation during implantation. The valve also has features like low permeability liners on the frame and mesh to restrict blood flow.

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Prosthetic heart valve design to reduce post-implantation issues like obstruction or gradients in the left ventricular outflow tract (LVOT). The valve has an outer frame with an angled anterior end and a raised atrial halo. The inner valve assembly is positioned closer to the ventricle centerline. This allows the valve to seat in the annulus without obstructing the LVOT. The inner frame can also have compressed posts or offset centerlines. These variations further enhance LVOT clearance.

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Stabilizing prosthetic heart valves to prevent migration during implantation and reduce the risk of valve displacement. The stabilization involves attaching the valve to the heart tissue using devices like clasps, barbs, or coils. This can be done by delivering a prosthetic valve with a cord and attachment device to a location near the valve annulus. The attachment device is then coupled to the heart tissue like papillary muscles or inner ventricular wall. The cord can also be connected to a ring implanted in the wall. This stabilizes the valve in place by anchoring it to the heart structure.

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Devices and methods for managing cardiac hemodynamics after implanting a prosthetic heart valve to prevent obstruction and optimize blood flow. The method involves using the prosthetic valve tether to pace the heart, deliver electrical signals, and sense cardiac measurements. This allows manipulating heart geometry and function to mitigate valve interference and promote adequate left ventricular outflow tract (LVOT) size. The tether can have electrodes for pacing and sensing. This provides a minimally invasive way to monitor heart response post-implantation and address issues like septal bumps that can narrow the LVOT.

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An artificial heart valve that aims to improve upon existing prosthetic valves for the mitral position by addressing issues like poor atrial drainage, leaking, erosion, and thrombosis. The valve design involves a ring structure that rises above the atrial bed to create a complete seal around the leaflets. This prevents retrograde blood from hitting the valve during systole, preventing regurgitation. The raised ring also helps align the leaflets properly for efficient ventricular filling during diastole. It aims to provide a customized, sealing, and thrombosis-resistant valve that addresses issues of existing prosthetic valves.

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Prosthetic heart valve that gradually adapts to the body after implantation to reduce the risk of left ventricular failure. The valve has a feature called a regurgitation device that allows some backward flow initially. This regurgitation gradually decreases over time as tissue grows into temporary openings. The device becomes fully effective after a deployment period allowing the body to adapt. The regurgitation device can be a member leaving openings in the leaflets or holes, a coiled spring, or scaffolds promoting tissue growth in other holes.

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An improved heart valve design that allows blood to flow around the valve instead of through the center. The valve has flaps that move inward from the lumen wall instead of opening in the center. This provides a larger effective surface area for blood flow. The valve also aims to prevent contamination and thrombosis by avoiding cells growing on the valve membrane. The design aims to optimize flow, minimize energy losses, and reduce the risk of complications compared to traditional valves with membranes attached to the lumen wall. The disclosure also proposes combining one-way valves with a balloon in the aorta to improve pumping efficiency.

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Prosthetic heart valve system that allows better fixing, capturing, and manipulation of native heart valve leaflets when a prosthetic valve is implanted. The system has a prosthetic heart valve with a leaflet clip that can transition between configurations. In the first configuration, the clip allows the valve to self-expand. In the second configuration, the clip captures the native leaflets between it and the valve body. A control element extends outside the heart to switch the clip configuration. This prevents native leaflet interference with prosthetic valve function by capturing them outside the flow path.

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A transcatheter heart valve design with improved leak prevention without significantly impeding compressibility for delivery. The valve has a flexible seal around the stent that conforms to the irregular native anatomy to reduce paravalvular leakage. The seal is made of a compliant material like pericardium or synthetic materials like PET or PEEK. This allows better sealing without adding bulk that impedes compression. The seal can be integrated into the stent design or added as an external skirt.

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A mechanical heart valve prosthesis that is specifically designed for implantation in the right ventricle to reduce the risk of blood clots compared to left ventricular implantation. The right ventricular valve has a different flow profile due to higher pressures, and lower flow through the valve hinge when closed. The valve is designed to address this by reducing turbulence, shear stress, and stagnant areas to prevent thrombus formation. This is achieved by optimizing the leaflet shape, hinge configuration, and flow geometry to minimize flow disturbances when the valve is closed. The aim is to provide a mechanical right ventricular heart valve prosthesis that reduces thrombus formation compared to a left ventricular valve implanted in the right ventricle.

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Minimally invasive heart valve replacement system with a collapsible valve design that allows compact delivery through small catheters followed by expansion at the implant site. The valve has a unique support frame with alternating cusp and commissure regions. The cusps mimic the natural aortic valve structure and the commissures contact the sinuses. Three cusp positioners fix the cusps and prevent blockage of the coronary ostia. The collapsible frame allows flexible leaflets attachment and constriction for delivery. It expands to position the cusps in the sinuses. The flexible frame material can be shape memory alloys for self-expansion or superelastic materials. The collapsible valve reduces trauma and complications compared to full-size valves.

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Collapsible prosthetic heart valve with a conformable sealing band to reduce leakage and improve implantation accuracy. The valve has a collapsible stent, valve assembly, and a conformable band that expands to seal gaps between the valve and body tissue. This band fills gaps between the implanted valve and native tissue to prevent leakage. It provides a better seal than relying on irregular native valve annulus geometry. The conformable band conforms to the tissue and expands with the stent to seal the valve position.

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Collapsible and reexpandable prosthetic heart valve with a cuff design that reduces perivalvular leakage, mitral valve compression, and conduction system disruption compared to conventional collapsible valves. The valve has a stent body with a radially expandable ring section. The cuff surrounds the stent body and has a pleated section that collapses during delivery and expands during expansion. The cuff also has an outward biasing element to push against the annulus. This allows the cuff to seal against irregular annuli without excessive force. The cuff can have pockets that expand radially during valve operation for stronger engagement. The cuff can also have a thinner ring section and thicker bulge sections for variable radial thickness. This reduces leakage by conforming to irregular annuli.

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Collapsible prosthetic heart valve design with improved durability, mitral valve impingement reduction, and leakage prevention compared to existing collapsible valves. The valve has a collapsible, annular supporting structure and flexible leaflets that form a chord across the interior of the structure. The leaflets extend beyond the chord and fold around commissure posts. This securement method prevents flap abrasion and reduces movement. The valve also has annular substructures connected by parallel linking members that don't deform during collapse/expansion. The design aims to provide long-term durability, prevent impingement on the mitral valve, and minimize leakage compared to prior collapsible valves.

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A prosthetic heart valve with a unique sewing cuff design that improves implantation and hemodynamics. The cuff surrounds the valve body and extends below the inlet end but not above the outlet end. The lower portion slopes down and away from the axis. It has scalloped sections with unequal arc lengths. This curved, sloping cuff shape allows better attachment to the native annulus compared to a flat cuff. It also maintains a more natural annular shape when implanted, reducing hemodynamic issues. The scalloped sections further aid attachment.

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Artificial heart valve that opens at a higher pressure than normal to increase blood flow to coronary arteries. The valve has moving parts that delay closing compared to a native valve. This allows blood to flow at lower pressure during diastole. The valve can be implanted surgically or using minimally invasive techniques. It may also have sensors, control units, and wireless power to monitor and optimize function.

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A prosthetic heart valve system with an integrated sealing mechanism to reduce paravalvular leakage around the implanted valve. The sealing mechanism extends over the stent frame and contains semi-permeable membranes and osmotic materials. When deployed, the sealing mechanism swells due to fluid passage through the membranes, conforming to the native tissue and reducing gaps. This prevents leakage between the prosthetic valve and native heart tissue.

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A delivery system for expandable heart valves that provides controlled expansion during implantation to reduce paravalvular leakage and improve outcomes compared to self-expanding valves. The system uses a catheter with a deployment mechanism to regulate the rate of valve expansion from contracted to final size. This prevents overexpansion and prolapse. It also allows stabilizing the valve before expansion and expanding it in stages. The mechanism has proximal and distal deployment fingers that radially move to regulate expansion. Alternatively, a gear shaft engages the valve gear track. The system aims to improve minimally invasive valve replacement (MIV) outcomes by enabling more precise expansion control.

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Intraluminal valve prosthesis for treating venous insufficiency that allows controlled retrograde flow. The valve has a support frame and at least one leaflet attached to it. The leaflet regulates forward flow through the vessel. But when closed, the leaflet allows a small amount of retrograde flow. This mimics natural valves that leak a bit to prevent pooling. The controlled retrograde flow reduces thrombus formation compared to fully closed prosthetic valves.

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