Frame Design for Prosthetic Heart Valves

A medical device, such as a prosthetic heart valve, with a frame made from a rhenium-containing metal alloy. The alloy composition and frame geometry are optimized to address deficiencies of existing prosthetic valves. The rhenium alloy provides high radial strength, low recoil, and improved durability compared to traditional materials. The frame geometry has an open cell pattern to reduce vascular access size, accurate annulus placement, and prevent foreshortening. The alloy and geometry enable a prosthetic valve with lower risk of vascular/neurological complications, better hemodynamics, and reduced valve embolization.

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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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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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Prosthetic heart valve with improved sealing to reduce leakage when implanted. The valve has an outer sealing member mounted around the frame outside of the leaflets. The sealing member is made of a fabric with a mesh layer and pile layer. The pile yarns extend outward from the mesh to provide a soft, plush texture. The density of the pile yarns varies in axial and circumferential directions. This allows the sealing member to stretch axially as the frame compresses for delivery, then relax when expanded. The variable pile density provides flexibility and conforms to the heart annulus better than rigid skirts.

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Implantable, mechanically expandable prosthetic devices like heart valves with frames that minimize the number of individual parts, maintain flexibility, collapses to a low profile for catheter introduction, and reduces risk of embolization compared to current frames. The frames use interwoven strut sets that pivot at junctions during expansion/compression. The struts have integrated hinges and locking members. The interweaving allows compact assembly without separate connectors. The strut sets have different deformation ranges for pivoting. Annealing can be done to optimize this difference. This allows the frame to collapse without separating strut sets, but expand fully without embolizing strut segments.

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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 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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A prosthetic heart valve that can be adapted for different implantation positions, procedures, and conditions using interchangeable components. The valve has a universal core with a contractible mesh stent and leaflets that can be anchored at the implant site using interchangeable adapters. The leaflets have movable cantilever struts connected by a wire. This allows tailoring the valve for specific applications by swapping adapters and sewing the components together. The interchangeable components enable versatility in implanting the valve for various positions, procedures, and conditions using a single valve design.

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Tissue-based replacement heart valve with improved durability and deliverability compared to traditional valves. The valve has a flexible, thin-walled valve body made from tissue layers that attach to a stent. The stent can compact and expand radially for minimally invasive delivery. The valve body is attached at the edges and commissures to the stent, but an inner layer with the leaflets is separate and attaches only at the edges. This prevents stress concentration and seams in the leaflet area. The stent can have a foreshortening section that longitudinally expands/contracts during compression/expansion. This allows the valve body to move longitudinally relative to the stent without stretching or crushing. The valve body can also have a longitudinally stretchable portion that stretches/contracts with the foreshortening. The separate inner and outer layers are

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Prosthetic heart valves with frames that expand and contract for customized sizing. The frames have interconnected struts with different segment lengths. The longer struts extend from the ends while the shorter ones connect between. This allows the frame to expand/contract by pivoting the struts. The strut length ratio lets the valve size adjust without needing to match the native annulus exactly. The valves also have features like locking mechanisms, skirt attachments, and expandable leaflets to facilitate implantation and retention.

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Prosthetic heart valve design with a cover that extends over the commissure edges to prevent protrusion during compression. The valve has a radially expandable frame, valve structure, and commissure cover. The cover is partially disposed over the commissure outflow edges. When the valve is compressed, the cover pulls taut to form a ramped surface from the frame to the commissure edge. This allows the valve to be advanced without engaging the commissure edges.

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Artificial polymer heart valve design with improved fatigue resistance and longer service life compared to conventional valves. The valve has a hollow frame with peaks at one end and multiple leaflets connecting adjacent peaks. The leaflets have a curved shape with at least one thinned region along the curve. The thinned regions increase stress dispersion and reduce peak stresses compared to uniform thickness leaflets. This improves fatigue resistance and extends valve life. The thinned regions also allow earlier leaflet opening for better overall valve performance.

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Prosthetic heart valves with improved assembly methods to reduce balloon abrasion during implantation. The valves have frames with collapsible and expandable struts. The valve structure inside has leaflets with tabs and cusps. The tabs connect to adjacent leaflets to form commissures that attach to the frame. During assembly, skirts are attached to the frame struts. This prevents direct contact between the struts and balloon during compression, reducing abrasion and degradation.

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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 design with improved commissure formation and attachment for enhanced durability. The valve has annular frame with leaflets attached by folded commissures. The folded commissural tabs of adjacent leaflets are overlapped and secured directly to a protruding portion of a mounting member. The mounting member is then attached to the frame. This provides rigid commissures without requiring extensive leaflet folding or suturing. It also allows easier assembly compared to wrapping the tabs around the frame. The folded tabs can be secured to the protruding member before attaching the entire assembly to the frame.

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Prosthetic heart valve design that allows for improved attachment of the expansion and locking assemblies and simplifies assembly. The valve uses clamps with side arms to attach the expansion and locking assemblies to the frame. The clamps are attached to junctions on the frame struts and have openings to receive fasteners. This allows the clamps to pivot with the frame during expansion. The expansion and locking assemblies have recesses to receive the clamps.

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Artificial heart valve design with leaflets that have reduced weight and improved durability compared to traditional heart valves. The leaflets have an inner section made of auxetic materials with negative Poisson's ratios and an outer section made of regular materials with positive Poisson's ratios. The auxetic inner section compresses in response to forces instead of expanding, reducing stress and preventing damage compared to a uniform positive Poisson's ratio material. The outer section provides durability and sealing.

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A medical device for replacing a worn-out prosthetic heart valve without open-heart surgery. The device is a new valve that can be implanted inside an existing prosthetic valve. The new valve has a lattice frame with protrusions that expand to engage the old valve's struts. This provides secure seating for the new valve inside the old one without reducing the blood flow area. The new valve can expand and replace the old one without needing a larger annulus. It allows valve-in-valve replacement of deteriorated prosthetic valves in lower-risk patients.

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Expandable prosthetic heart valve with frame design that reduces interaction with the native anatomy and mitigates valve dysfunction. The frame has an offset inflow end with struts that extend axially beyond the inflow end. Leaflet cusp edges are attached to these offset struts. This reduces valve-native tissue interaction compared to struts extending directly into the left ventricle outflow tract. The offset struts also provide better support for the leaflet cusp edges during closure.

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Prosthetic heart valve with improved coaptation and pressure gradients for use in transcatheter aortic valve replacement (TAVR) procedures. The valve has a radially expandable frame with leaflets linked to it. The leaflet inflow edges have movable portions that radially contract when the valve closes to prevent leakage. The leaflet outflow edges coapt to fully close the valve. The movable inflow edge sections allow proper coaptation and pressure gradients over a range of sizes. The frame design allows radial expansion and compression. The leaflets have commissures that attach to fixed frame sections. The movable inflow edge sections contract radially to facilitate leaflet coaptation. The frame expansion mechanism and locking features prevent overexpansion.

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Prosthetic heart valve design with improved performance for smaller diameters. The valve has quadrilateral leaflets, shorter frame height, and external commissure supports to reduce risk of leaflet snapping, coronary access obstruction, and valve-on-valve misalignment. The leaflets are attached to the frame via external commissure supports instead of sewing them directly to the frame. This allows the leaflets to be positioned closer to the inflow end without extending beyond the annulus. The external supports also prevent leaflet bouncing at the outflow end. The valve also has shorter overall height and reduced frame openings for smaller diameters.

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Prosthetic heart valve design with improved commissure assembly and leaflet attachment to reduce wear and deformation. The valve has commissure tabs on adjacent leaflets folded into overlapping layers that surround the commissure support element. This protects the leaflet bodies from forces pulling the tabs during valve operation. The folded tabs surround the element axially and radially, reducing stress concentration compared to simple attachment. The folded tabs also reduce lateral movement and sliding. The folded commissure configuration is formed by overlapping layers that extend through the commissure element window and outwardly.

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Heart valve prosthesis with a collapsible and expandable frame made of non-uniform struts for minimally invasive implantation. The frame has struts of varying thickness and width to compress into a smaller profile for delivery through small arteries. The non-uniform strut design allows the frame to collapse and expand without kinking or buckling during insertion and expansion. This enables transcatheter implantation of the valve without open-heart surgery. The frame attaches to the valve commissures using windows or posts for anchoring.

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Stemless prosthetic heart valve that minimizes the risk of cardiac pacing issues post implantation. The valve is secured to a lumen of the stent frame and has a lattice structure forming a tubular shape defining a circumference.

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Collapsible heart valve with design features to reduce wear and improve implantation. The valve has a frame with inwardly extending commissure attachment posts that support the leaflet commissures. This keeps the leaflet moveable portions inside the frame when open to prevent contact with the frame. It also has features like struts and gaps to further prevent leaflet-frame contact. This reduces wear and improves durability compared to valves with leaflets directly attached to the frame. The collapsible frame allows transcatheter delivery through small access points.

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

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Prosthetic heart valve design with improved durability and manufacturing efficiency for commissure attachment. The valve has a stent with a dedicated feature called the commissure attachment between the inflow and outflow ends. The commissure attachment has a frame with an opening. The valve also has a skirt connected to the commissure attachment frame. The leaflets are attached both through the opening and outside the commissure attachment feature. This dual attachment method provides stronger commissure fixation while allowing flexible skirt movement.

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Prosthetic heart valve with commissures that can slide axially relative to the frame during radial compression and expansion. This allows the commissures to maintain a constant height without axial deformation as the frame size changes. The commissures are mounted on sliding elements attached to the frame. This allows the commissures to move axially when the frame is compressed versus expanded. This prevents the commissure height from changing as the frame size changes.

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

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A prosthetic heart valve with a unique frame design that aims to overcome the drawbacks of current designs. The frame has inner and outer struts that pivot at joints to form a collapsible and expandable structure. The struts have recessed portions at the pivot joints where segments of other struts are seated. This allows the struts to move parallel when compressed instead of shearing like scissors. It also prevents gaps forming between struts in the expanded state.

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Prosthetic heart valve design that enables smaller size and easier implantation compared to existing valves. The valve has an outer frame with anchor portions that attach to the heart tissue. An inner frame is connected only at the anchor locations inside the outer frame. This allows the outer frame to expand and anchor in the heart, while the inner frame remains compact during delivery. The valve is delivered through a small incision and expands inside the heart, reducing protrusion into chambers. The anchored outer frame secures the valve without needing extensive tissue fixation.

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Prosthetic heart valve design with features to secure the commissure components to the frame during implantation and prevent movement. The valve has commissural support posts on the frame with protrusions perpendicular to the longitudinal axis. Commissure lugs from adjacent leaflets wrap around these posts. The protrusions restrict axial movement of the commissure lugs in the downstream direction. This prevents dislodging during crimping and deployment. The protrusions can have slots or wider end portions to accommodate the leaflet lugs.

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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 valve with improved leaflet assembly for reducing leaflet wear and increasing valve opening diameter. The leaflets have subcommissural lugs extending radially inward towards the frame when the valve is expanded. This prevents folds or slacks in the unattached subcommissural portions that can contact the frame during valve closure. The subcommissural lugs mate with adjacent leaflets to connect them inwardly. The commissure lugs attach the leaflets to the frame. This allows the leaflets to fully open without restriction when the frame compresses during implantation.

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Tapered prosthetic heart valves with improved flow characteristics and implantation techniques. The valves have a unique shape and tab configuration that allows for a tapered flow channel. The frame expands into an inverted frustoconical shape with a larger diameter outflow end. The leaflets attach via tabs that form commissure assemblies. In the open valve position, blood flow through the tapered channel increases gradually. The tabs and leaflet shapes allow the valve to close without contacting the frame during systole. The frame-leaflet coupling at annular backflow locations prevents leaflet-frame contact when the valve is open. This allows the tapered channel to expand fully.

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

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Prosthetic heart valve design with improved durability and reduced wear compared to conventional designs. The valve has a unique leaflet assembly with asymmetrical leaflets joined at angled tabs. Each leaflet has a vertical tab extending orthogonally from one side and folding over an adjacent leaflet. This creates annular commissures without centrally-located fabric or reinforcements. The asymmetry and folded vertical tabs space the leaflet articulation axes inward, reducing abrasion against the frame.

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Heart valve that facilitates valve-in-valve procedures and simplifies manufacturing techniques. The valve includes a dual wireform support frame that is reshaped into an expanded form in order to receive and/or support the expandable prosthetic heart valve therein.

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Assembling leaflet commissures in prosthetic heart valves to improve durability and reduce size during crimping. The commissure attachment assembly uses a support member that surrounds the folded commissure tabs to secure them to the frame post. The tabs are clamped by the support member and held in place by attachment members that loop around the post. This assembly prevents slipping or rotation during crimping and expansion. The support member can bend radially to tighten around the tabs. The looped attachment members tighten around the post channels.

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Collapsible prosthetic heart valve with a frame design that improves anchoring and reduces paravalvular leakage. The frame has an indentation that forms against the native valve annulus during expansion. This creates a sub-annular bulge that aids in anchoring the valve. The indentation is formed by compliant wires in the frame. Pressing the frame against the annulus during deployment causes the indentation to form. The bulge below the indentation prevents paravalvular leakage by providing additional anchoring force.

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Collapsible prosthetic heart valve with a frame design that helps anchor it securely in place during implantation. The frame has an indentation near where it contacts the native valve annulus. When the valve expands, the frame compresses slightly in that area forming an indentation. This bulging sub-annular portion aids in anchoring the valve and prevents paravalvular leakage by impeding movement of the valve. The frame can also have an expandable pivot arm that extends outward when the valve expands, providing additional anchoring force.

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A prosthetic heart valve design to minimize stress on the valve leaflets for improved durability. The valve has a collapsible stent frame with flexible connections between the stent cells. The flexible stent has a main body with proximal and distal ends, support struts, and one or more support posts. The stent cells at the proximal and distal ends are longitudinally spaced apart.

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

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

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

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A radially collapsible and expandable prosthetic heart valve with an improved outer skirt design to reduce paravalvular leakage. The skirt has a fixed inflow edge and a movable outflow edge with alternating protrusions and notches. This allows the skirt to retract radially within the frame when the valve is collapsed, preventing excess material that can cause leaks during implantation. The skirt creases and openings align with frame struts to facilitate uniform crimping.

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Prosthetic heart valve that can be implanted percutaneously with guiding catheters. The valve includes a stent, a wire mesh, a collapsible wire valve frame and many other components that facilitate its stabilization and anchoring in the anatomic structures it contacts.

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Heart valve replacement prosthesis designed to prevent paravalvular leakage and securely anchor in place without requiring open heart surgery. The prosthesis has an expandable frame, valve body, and skirt to replace a native valve. The frame expands to fit the native annulus. The skirt prevents leakage around the exterior of the frame. The skirt can be partially porous or with holes to allow some regurgitation initially. The prosthesis also has anchors to attach to the native tissue for securement. This reduces paravalvular leakage compared to traditional prostheses. It also enables delivery via minimally invasive techniques since the prosthesis expands in place rather than relying on sutures or other fixation methods.

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A transcatheter heart valve design that aims to reduce tissue trauma and stress during implantation compared to conventional valves. The valve has an annular frame with an inner skirt that extends around the frame's internal surface. This inner skirt reduces contact between the frame and the native tissue at the implant site, minimizing the risk of injury and complications during insertion. The skirt also helps anchor the valve in place. The skirt has a portion that extends inside the frame and a separate portion that extends out of the frame.

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