Leak Prevention in Prosthetic Heart Valves

A system and method to prevent paravalvular leak (PVL) in replacement cardiac valves. The system uses a containment ring that actively couples to the native valve annulus to prevent axial migration. Inside the ring, a resilient valve scaffold engages both the ring and native valve. This prevents scaffold translation. The ring has anchors that continuously bias the annulus tissue towards the ring. The scaffold transitions from insertion to operative configuration within the ring. This encloses the scaffold vertex inside the ring, preventing axial movement. The ring and scaffold prevent PVL by restricting valve migration.

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An expandable prosthetic heart valve with improved sealing to reduce paravalvular leakage. The valve has an annular frame that compresses for delivery and expands when implanted. A sealing member surrounds part of the outer frame surface near the inflow end. This member bulges outward when the valve expands, sealing against the tissue. The sealing member length matches the frame's compressed length. This allows the frame to expand without damaging the sealing member. The sealing member can have a mesh layer with pile yarns extending outward. The inner mesh surface contacts the frame, while the outer pile yarns bulge out.

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Prosthetic device for sealing a native heart valve and reducing regurgitation while preserving native valve function. The device has clasps that attach to leaflets and close during systole to prevent regurgitation. The clasps have flexible ends that move apart during diastole as leaflets open. This allows leaflet motion while still sealing. The clasps flex to move together during systole. The clasps can also bend to adapt to leaflet shape. A coaptation element in the valve orifice further helps seal. The clasps and coaptation element can self-expand after delivery. The device can be delivered through a catheter.

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Artificial heart valve design to reduce paravalvular leakage and compressible size. The valve has a collapsible support structure with rows of misaligned grid structures. Seals are placed over portions of the grids. When the valve expands, the seals cover the grids to prevent regurgitation. When the valve collapses, the seals shrink. This reduces paravalvular leakage without adding bulk.

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Transcatheter valve prosthesis with an anti-paravalvular leakage component to prevent blood regurgitation around the valve when deployed in a native heart valve. The anti-PVL component has an inner skirt on the valve stent and an outer wrap forming a cavity accessible via a one-way valve. Blood can flow into the cavity but not out. When the valve expands, the outer wrap expands, too, filling gaps and sealing against the native valve. The cavity fills with blood, clots, and seals permanently.

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Prosthetic heart valve design to improve sealing and anchoring at the implantation site. The valve has features to conform better to non-circular native valves and reduce paravalvular leakage. The valve has anchors that extend radially outward from the leaflets to engage the native valve annulus. It also has anchors that abut the leaflets to prevent prolapse. This allows secure fixation of the valve without requiring circular symmetry. The valve can also have features like distal anchors, expandable frames, adjustable outer diameters, inflatable seals, and frameless seals for better anchoring and sealing.

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Transcatheter mitral valve replacement system with a prosthetic half-valve that attaches directly to the native mitral valve annulus to prevent displacement and regurgitation. The prosthetic half-valve has a stent with an atrial portion to anchor the valve and a ventricular portion to displace the diseased leaflet. Dual guide and fixation (DGF) members with compressible legs secure the stent to the annulus. The prosthetic leaflets attach to the stent and skirt. The half-valve design allows for compact delivery, improved anchoring, and reduced paravalvular leakage compared to full-size prostheses.

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An artificial heart valve design to reduce paravalvular leakage while compressing smaller for delivery through narrow vessels. The valve has a collapsible support structure with misaligned grid rows, an inner skirt, artificial leaflets, and external seals. The seals cover grid sections and expand radially when blood regurgitates into pockets formed by the misaligned grids. This enhances seal against native tissue and prevents paravalvular leakage.

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A heart valve prosthesis with a sealing mechanism to prevent paravalvular leakage in minimally invasive valve replacements. The prosthesis has a frame to support the artificial valve leaflets and a sealing mechanism covering the frame surface. The sealing mechanism has layers, like an inner hydrophilic layer and an outer non-permeable layer, that expand when wet to seal against tissue. This helps fill gaps and prevent leakage around the prosthesis. The double-layer frame distributes functions like leaflet support and sealing to different parts.

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A replacement stent assembly for prosthetic heart valves that reduces paravalvular leakage. The stent has an attached cuff that can invert between two orientations - inside the stent lumen and over the stent abluminal surface - using shape memory or elastic members. This allows the cuff to seal against the stent and tissue when deployed to reduce leaks, but retract inside the stent for delivery to maintain a low profile.

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Prosthetic mitral valve with improved design to reduce regurgitation and improve blood flow compared to conventional mitral valve replacements. The valve has features like angled outflow orifice, offset centerline, and flange directing flow towards the posterior wall to enhance flow dynamics. It also has a frame expandable into the native valve for anchoring. The valve is delivered minimally invasively into the native valve. The unique design aims to improve regurgitation reduction and blood flow compared to conventional mitral valves.

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Tricuspid valve prosthesis that is fixed on the ventricular septum to prevent paravalvular leakage. The prosthesis has a stent, artificial valve leaflets, a sealing device, and an anchoring member. The sealing device is unique in design to prevent paravalvular leakage. It has a sealing rod and an elastic adaptation layer. When the atrial wall squeezes the sealing device, the sealing rod folds toward the bottom of the native valve annulus, preventing gaps and folds in the atrium segment. The elastic adaptation layer compresses and expands with the native valve annulus, fitting and sealing it. This avoids blood reflux from folds and gaps.

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An artificial heart valve designed to reduce paravalvular leakage and minimize the risk of displacement during implantation compared to conventional valves. The valve has features like an inflow sealing membrane, an outflow sealing membrane, a leaflet, and a leaflet anchor. The inflow sealing membrane is made of a hydrophilic material that expands when contacting blood to prevent leakage. The outflow sealing membrane covers the inflow sealing membrane to further reduce leakage. The leaflet anchor is a coiled structure that wraps around the chordae tendineae outside the native valve to secure the valve in place.

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An artificial heart valve with features to improve stability and reduce paravalvular leakage compared to standard heart valve replacements. The valve has a unique design with a valve support, sealing membranes, a leaflet, and an anchor. The valve support has an inflow section and outflow section. A first sealing membrane covers the outside of the inflow section. A second sealing membrane is on the inside and folds outward. The folded second membrane covers part of the first membrane to prevent leakage. The leaflet is inside the support. An anchor outside the chordae tendineae helps stabilize the valve during heart contractions.

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An artificial heart valve prosthesis with a sealing device to prevent paravalvular leakage when the heart beats. The valve prosthesis has a sealing frame connected to the support structure. The sealing frame provides a fulcrum point. When the heart contracts, the sealing frame rotates around the fulcrum, with one curved segment moving inward and the other outward. This action drives the valve leaflet to fit against the native valve annulus and atrial wall. It also lifts the sealing member to fit against the native valve annulus. This ensures tight sealing during contraction and expansion cycles.

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Collapsible prosthetic heart valves with sealing mechanisms to mitigate paravalvular leakage. The valves have expandable sealing members attached to the cuff surrounding the stent body. These members have openings facing the blood flow direction. When blood flows retrograde, it pushes into the sealing members causing them to billow outwardly against the tissue, sealing against leakage. The sealing members can be rectangular, triangular, trapezoidal, or semicircular.

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A prosthetic heart valve with a sealing feature to prevent paravalvular leakage (PVL) around the valve annulus while minimizing delivery profile. The valve has an inner stent frame, an outer anchor assembly, a gasket, and leaflets. The gasket surrounds the outer anchor waist portion to seal against the annulus. In the collapsed state, the gasket doesn't extend beyond the anchors. This allows a smaller delivery profile. The outer anchor has a concave waist that aligns with a convex skirt protrusion. This geometry helps prevent PVL. The inner stent, outer anchor, gasket, and leaflets expand to implant the valve.

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A percutaneously implanted heart valve design that reduces paravalvular leakage during transcatheter valve replacement. The valve has a unique holder structure that helps prevent blood regurgitation around the edges. The valve holder has a grid-like frame with blocked sections. The valve leaflets are mounted inside the frame. The skirt around the valve attaches to both the leaflets and the bottom of the frame. During implantation, the compressed valve is expanded in place to replace the native valve. The blocked sections of the frame prevent blood from flowing between the native annulus and the valve holder, reducing paravalvular leakage.

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Artificial heart valve connection structure to prevent paravalvular leakage in transcatheter aortic valve replacement (TAVR) procedures. The structure connects the artificial heart valve support and the valve leaflets in a way that prevents paravalvular leakage. It uses features like sutured membranes, zigzag skirts, and sealing strips to securely attach the valve components. This reduces the risk of leaks between the valve and the native heart tissue, which can cause complications. The sutured membranes cover the inflow end of the support, with a matching zigzag skirt. A sealing strip attaches to the leaflet and has a clip to fold over the support. This provides a secure and leak-free connection between the valve components during TAVR implantation.

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Prosthetic heart valve design to reduce paravalvular leakage and provide secure anchoring. The valve has a modular structure with customizable anchors that can engage the patient's heart structures like chordae tendineae, trabeculae, or calcified native valve tissue. The anchors pass through a sealing body that abuts the heart to prevent leakage. This allows the valve to be anchored atraumatically and securely without relying solely on calcified native valve tissue engagement. The modular design enables customizing the anchor configuration for different patient anatomies.

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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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Heart valve prosthesis device to reduce paravalvular leakage during minimally invasive valve replacements. The device has a sealing mechanism covering the frame that carries the artificial valve leaflets. The sealing mechanism has layers with liquid absorption ability. This allows it to expand and fill irregularities between the prosthesis and native tissue, preventing leakage. The outermost layer is a hydrophilic seal that absorbs fluid and expands to assist in sealing.

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Hybrid surgical prosthetic heart valve with improved sealing to reduce leakage around the implant compared to traditional valves. The hybrid valve has a non-expandable valve member with leaflets mounted on an annular support structure, and an expandable stent attached to the inflow end of the support structure. Sealing structures around the stent prevent leakage. These include flaps, covers, pleated skirts, foam strips, hydrophilic bands, and tissue adhesives that expand and seal against the native tissue when the stent is expanded. The expandable stent allows rapid implantation by expanding against the tissue instead of suturing.

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Valve prosthesis for replacing a damaged heart valve that reduces paravalvular leakage after implantation compared to conventional prostheses. The prosthesis has a clamping mechanism with a reinforced section near the valve annulus that provides higher rigidity compared to the surrounding bonding area. This prevents the clamping mechanism from collapsing between the valve leaflets when they move. Additionally, the prosthesis has a skirt that tightly fits the native valve leaflets to seal against the heart tissue and prevent leakage around the prosthesis. The reinforced clamping area and tight-fitting skirt help stabilize the prosthesis in place and reduce paravalvular leakage compared to conventional prostheses that may allow movement and gaps between the prosthesis and heart tissue.

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Prosthetic heart valve with sealing elements to prevent paravalvular leakage. The valve has a compressible stent support and a valve element with attached sealing strips. The strips protrude from the valve element when expanded to touch the native tissue and seal against leakage. The strips are spaced and shaped to avoid tangling. This improves fixation and reduces leakage compared to valves without sealing elements. The sealing strips can be made of tissue or synthetic material.

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Prosthetic heart valve design to reduce or eliminate perivalvular leakage around the valve after implantation. The valve has a frame, valve component, and a sealing member with ribs, drapes, and cords. The ribs extend radially from the frame. Drapes extend radially between the frame and ribs. Cords connect the frame and ribs. The drapes and cords limit rib expansion relative to the frame. This sealing configuration helps prevent leakage around the implanted valve.

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Heart valve prosthesis device with improved sealing to prevent paravalvular leakage. The device has a frame structure with artificial valve leaflets and a sealing mechanism covering the frame. The sealing mechanism includes layers with liquid absorbing ability, like expanded polymer seals. These seals absorb fluid and expand to fill gaps and prevent leakage. The outermost seal expands to match irregular valve shapes. The inner seals cooperate to further prevent leakage and thrombus.

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Collapsible prosthetic heart valve design with improved sealing and reduced risk of leakage compared to conventional collapsible valves. The valve has a stent, valve assembly, and a cuff that extends beyond the stent proximal end. This cuff surplus portion can be expanded to form a larger sealing structure around the native valve annulus at the proximal end. This compensates for irregularities in native valve geometry and reduces gaps between the implanted valve and native valve tissue. The larger cuff diameter sealing structure helps prevent leakage compared to a regular cuff size.

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A stented prosthetic heart valve with a wrap to prevent paravalvular leakage and delivery devices to selectively deploy the wrap. The wrap is made of a flexible material that can be stretched over the stent frame of the valve and anchored at various points to cover and seal any gaps between the prosthetic valve and the surrounding native tissue. The wrap can be selectively deployed after the valve is implanted using a delivery catheter with retractable sheaths. The sheaths cover the wrap during delivery and can be retracted to expose the wrap for deployment. This allows the wrap to be precisely positioned and anchored where needed to seal paravalvular gaps. The wrap can also be repositioned or retrieved if necessary.

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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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Catheter-based prosthetic heart valves with sealing members to prevent regurgitation, and delivery systems for implanting them. The valves have a collapsible frame, expandable valve, and a skirt assembly. The skirt has upper and lower skirts to connect the valve to the frame, and an outer sealing skirt that protrudes through the frame cells when expanded. This seals against the native tissue. The delivery systems have sheaths with inner liners made by expanding a polymer tube against a metal sleeve. This reduces friction and kinking during insertion. The valve can be advanced with precise controlled motion for deployment.

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A prosthetic heart valve with a sealing skirt that prevents regurgitation around the edges of the valve when implanted. The skirt protrudes through the frame cells when expanded. It also has a collapsible frame, expandable valve, and collapsible skirt assembly. The valve can be delivered through a catheter and expanded in place. The skirt prevents contact with the valve and couples to the frame. The catheter also has a liner made by expanding a polymer tube inside a metal sleeve.

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Heart valve replacement device with a sealing member to prevent paravalvular leakage around the implanted valve. The sealing member is separate from the valve and has protrusions that extend radially outward when attached to the collapsible stent. These protrusions contact the native annulus to create a sealed interface and prevent blood leakage. The protrusions can be formed by folding or pinching the sealing member material. This allows the stent to self-expand and reposition without compromising the seal. The sealing member can be positioned internally or externally on the stent.

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A prosthetic heart valve with improved fit, apposition, and paravalvular leakage mitigation compared to conventional valves. The valve has an anchoring structure made partially from a hydrophilic material that swells when contacted with blood. This swelling improves the device's fit and sealing against the native tissue, reducing paravalvular leakage. The hydrophilic material is located in areas like the annular surface to specifically address issues like calcification that affect sealing.

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Transcatheter heart valve with a sealing component to prevent paravalvular leakage around the prosthetic valve. The component is a self-expanding ring with segments that curve radially away from the valve stent. The segments attach to the stent surface at spaced points. When deployed, the ring expands and fills gaps between the valve and native valve annulus to seal against leakage. The segments have varying flexibility to conform to the native anatomy.

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Collapsible prosthetic heart valve design with a cuff feature that reduces paravalvular leakage when replacing native heart valves. The cuff has a first orientation where it extends outward from the stent and a second orientation where it lies against the stent's abluminal surface. Members connect the cuff to the stent and can be tensioned to hold the cuff outward for delivery. After implantation, the members relax and hold the cuff against the stent to seal against the native valve annulus. This reduces gaps and leakage compared to a cuff that stays outward.

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Prosthetic heart valve design to reduce paravalvular leakage during implantation. The valve has sealing members mounted on its outer surface that are precisely positioned at commissural points of the native valve. This ensures alignment with gaps that can form between the implanted prosthetic valve and native annulus. The sealing members engage these gaps to prevent leakage. By locating the seals in the waisted middle section, it doesn't impact the crimped diameter for transcatheter delivery.

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Prosthetic heart valve for implantation at the mitral valve that reduces migration and improves fixation compared to existing mitral valve replacements. The valve has a radially expandable frame with projections that penetrate the native mitral valve leaflets to secure the prosthetic valve in place. This provides better anchoring and migration resistance compared to valves that just expand inside the annulus. The projections engage the leaflets during implantation to fix the valve in position. The valve can be delivered transapically or transatrial and expands inside the leaflets.

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Heart valve replacement system with an expandable and collapsible stent, a heart valve mounted inside the stent, and a sealing member around the stent inflow end. The sealing member expands to seal against the native annulus and prevent paravalvular leakage. It can collapse for delivery through a catheter. The stent connects to the sealing member at points. This allows the sealing member to extend around the stent and fill gaps between the stent and annulus for a better seal.

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Collapsible prosthetic heart valve with a sealing member that can move to reduce paravalvular leakage. The valve has an expandable stent, leaflets, and a cuff. The sealing member extends from the cuff to a free edge. It can be moved from an extended position proximal to the stent to an inverted position distal to the stent after initial deployment. This inverted position allows the sealing member to engage the native valve annulus and reduce gaps between the valve and native valve, reducing paravalvular leakage.

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Transcatheter heart valve system with reduced paravalvular leakage. The system has a separate anti-leakage component that is implanted first, followed by the valve component. The anti-leakage component has a fixed portion that anchors to the native valve and a sealing portion that fills gaps. This component is made of a shape memory alloy that self-expands after release. The valve component has a skirt that attaches to the valve holder. By implanting the anti-leakage component separately, it can be optimized for filling gaps and anchoring, while the valve component focuses on valve function.

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Prosthetic heart valve design to reduce paravalvular leakage by adding a tissue liner inside the outer layer of the valve support structure. This liner prevents blood flow between the valve leaflets and the support structure. The liner can extend through gaps in the support structure or be attached to the inner or outer surface of the middle layer. The valve also has a tissue skirt attached to the inner or outer surface of the middle layer to further reduce leakage.

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Prosthetic heart valve design to improve performance and reduce complications compared to existing valves. The valve has features like an elevated ring structure in the atrium to promote complete leaflet closure, a compliant cuff at the annulus to secure the valve, and a thrombus containment bag. These features aim to prevent regurgitation, leaks, erosion, thrombosis, and obstruction issues seen with conventional valves. The elevated atrial ring promotes complete leaflet closure during ventricular contraction. The compliant cuff provides annulus fixation. The thrombus bag captures blood clots inside the valve.

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Collapsible prosthetic heart valve with improved sealing and accuracy during implantation to reduce risks and complications compared to conventional valves. The valve has a stent, valve assembly, and elongated legs that can transition between an extended configuration for delivery and a relaxed configuration for implantation. A sealing portion connects the legs and forms a sealing structure when the legs relax. This helps fill gaps between the valve and native annulus during implantation to prevent leakage. The legs can extend further than the valve for easier delivery and then relax to better conform to the annulus shape.

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Collapsible prosthetic heart valve with reduced paravalvular leakage by optimizing the fit between the valve and the native annulus. The valve has a unique cuff design with features like concave struts, notches, and gathered edges. These features allow the cuff to better fill gaps between the valve and native annulus, reducing paravalvular leakage. The concave struts on the stent have curved shapes that allow the cuff to billow outward and fill gaps. The notches and gathered edges on the cuff can close up to match the irregular native annulus better.

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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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Replacement heart valve with a tubular anchor that can be delivered and deployed through a catheter. The valve has a seal at the inflow end that attaches the leaflets. This allows the leaflets to fold inward during delivery and then evert outward when deployed. The seal prevents backward leakage. The seal has a polymeric section and a fabric strip fixed to it. The leaflets are attached to the fabric strip using a single suture at the secured end. This creates a joint where the inner and outer layers of the fabric strip align. The sealed leaflets are then placed against the outer surface of the tubular anchor and attached at some points using lashings. This holds the seal and leaflets in place while deploying the valve.

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Reducing regurgitation through a heart valve like the aortic valve using a prosthetic device that can be implanted less invasively than a full valve replacement. The device has an anchoring member to secure it in place and an expandable insert member that deploys between the valve leaflets to fill gaps and prevent backward flow. The anchoring member can be a stent expanded in the aorta or attached to an ingrowing left ventricle anchor. The device is delivered percutaneously to treat aortic valve insufficiency without open heart surgery.

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Sutureless prosthetic heart valve with features to prevent paravalvular leakage. The valve has anchoring features on opposite sides of the stent to secure it in place without sutures. It also has sealing rings with spaced tubes to create a barrier around the valve assembly. This prevents regurgitation through the annulus gaps. The valve can be implanted without exposing the native valve, reducing risks and complications compared to open-heart surgery.

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Collapsible prosthetic heart valve with improved mechanisms to seal against paravalvular leakage. The valve has expandable sealing members attached to the cuff that billow out when blood flows in the reverse direction. This helps prevent leakage between the valve and native tissue by sealing the gaps. The sealing members have open sides facing the blood flow direction and closed sides facing opposite. The members can be rectangular or triangular shapes. They expand into pockets on the cuff when deployed.

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