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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