Collapsible Valves for Prosthetic Heart Implants

Valve frame assembly and artificial heart valve that can be delivered and implanted in a single step without separate components for anchoring. The assembly has a valve frame body that accommodates the artificial leaflets, an anchor to clamp the native valve, and a connecting mechanism that allows radial swing and axial movement between the frame and anchor. This allows the frame to compress during delivery and expand to fix against the native valve, without needing a separate anchoring device. The connecting mechanism allows some swing to compensate for misalignment during implantation.

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Valve frame assembly, artificial heart valve, and replacement system that allows easier and more reliable implantation of artificial heart valves. The assembly has an anchor connected to the valve frame body that expands to clamp the native valve. The anchor has elasticity and is annular when expanded. It has an outer mechanism, multiple extensions, and bases. The valve frame body is accommodated inside the compressed anchor. The outer tube delivery system compresses the anchor and valve frame inside. The anchor is released first by axially moving the outer tube, then the valve frame by moving the inner tube. This allows implanting the entire assembly as a unit.

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Replacement heart valves that can be compacted for delivery and then expand in the body to the desired size without excess expansion that could enlarge the valve annulus. The valves have frames that can foreshorten longitudinally when compacted and then expand when deployed. This allows the frames to reduce diameter without compressing the valve body, preventing annulus enlargement. Features like tethers, rings, and reverse foreshortening anchors constrain frame expansion after deployment.

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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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Collapsible prosthetic heart valve for replacing the tricuspid valve that has a single expandable frame with a fabric tube suspended inside. The tube allows blood flow and the frame anchors the valve. This eliminates the need for a separate inner frame to support the leaflets. The fabric tube is attached to the frame with sutures and forms the valve without separate leaflets. The tube collapses and expands with the heartbeat.

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Collapsible prosthetic heart valves with sealing members to protect the valve during implantation. The valves have a sealing assembly that completely covers the leaflets at one end when compressed. This assembly forms a pocket between the sealing member and the leaflets. The pocket allows the frame to extend without protruding through the skirt during compression. This prevents valve damage during delivery through narrow catheters. The pocket is formed by folding the inner skirt over itself at the frame end.

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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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Collapsible and expandable prosthetic tricuspid valve that can be delivered through the vasculature in a transcatheter procedure. The valve includes a collapsible and expandable frame that, in an expanded condition, includes a central portion, an atrial portion flaring radially outwardly from the central portion, and a ventricular portion flaring radially outwardly from the central portion.

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Prosthetic heart valve system for transcatheter replacement of the native tricuspid valve. The system has an expandable frame with flared atrial and ventricular portions to clamp the annulus. The frame has inner sheets extending radially inward. A cylindrical leaflet support structure connects the sheets. This forms a central conduit between the sheets. Shunts in the sheets allow blood flow around the leaflets. An occluder seals the shunt initially. A guidewire passes radially outside the conduit for catheter delivery. The shunts and guidewire path avoid obstructing valve leaflet motion.

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Prosthetic heart valves with actuator rods that expand and contract the valve frame without exposing the threads to the valve or surrounding tissue. The actuator rods extend partially through posts of the frame, with a threaded portion inside and an unthreaded portion exposed. When the frame is compressed, the threaded portion is fully inside a post. This prevents threads from interacting with the valve leaflets or native tissue during deployment.

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Implantable expandable prosthetic heart valves that isolate the actuators from the bending stresses caused by radial compression of the frame of the prosthetic heart valve assemblies. The valve includes a frame, a valvular structure, an actuation assembly, and a valve.

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Transformable heart valve with a stent and leaflets that can be compressed for delivery and expanded in place during implantation. The valve has a stent with a lumen and a separate valve portion with leaflets. In the compressed state, the leaflets are outside the stent. To implant, the valve is advanced, expanded to engage the annulus, then transitioned by sliding the valve portion into the stent lumen. This avoids separating components during delivery. The stent expands along with the valve.

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Prosthetic heart valve and delivery system with improved sealing and delivery capabilities for transcatheter implantation. The prosthetic valve has a collapsible frame, expandable valve, and skirt assembly that seals against the native annulus. The skirt has upper and lower skirts to prevent contact with the valve. When expanded, protruding skirt sections seal gaps. The delivery system has an inner liner made by expanding a polymer tube against a metal sleeve. This allows controlled expansion and contraction without compressing the shaft. It also enables lower profile sheaths for smaller access points.

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A collapsible prosthetic heart valve that can be collapsed for minimally invasive delivery and expands after implantation. The valve has a collapsible stent with a downstream ring connected by flexible struts near the commissures. This prevents the leaflets from contacting the ring. The stent has a serpentine outflow edge with inner and outer rings. The ring has small connections to the outer ring, allowing leaflets to be inserted between them. This configuration reduces impingement, paravalvular leakage, and leaflet abrasion compared to prior designs.

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Expandable heart valve replacement prosthesis with improved longevity and hemodynamic performance compared to existing devices. The prosthesis has an expandable frame with the valve components attached to the outer surface instead of the inner lumen. This prevents the frame from contacting the native heart tissue, reducing inflammation and calcification. The frame design with expandable regions and valve posts allows customization of leaflet size and spacing for optimal flow dynamics. The valve components can be made from biomaterials like polymers, bovine tissue, or pericardium.

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Mechanically expandable heart valve implant and delivery system that allows for controlled, precise, and reversible expansion and locking of the valve frame after deployment. The expandable frame has a guide member and base member connected by wires. The delivery system has a sleeve that can push/pull the guide and base members together to expand the valve diameter. The wires can then twist and lock to maintain expansion. The sleeve can be moved to unlock and compress the valve for retrieval if needed.

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Prosthetic heart valve that can be compressed and expanded for transcatheter delivery. The valve has distal, proximal, and septal subannular anchoring elements to secure it in a native valve annulus. The septal element extends below the annulus to stabilize the valve against rotation. This anchoring configuration allows the valve to be side-loaded into a catheter for delivery instead of fully compressing it radially. It is released from the catheter to expand and anchor in the annulus. The septal element pinning the native leaflet prevents dislodgement.

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Collapsible transcatheter heart valve that can be delivered through a small catheter and expanded inside the heart to replace a diseased valve. The valve has a radially collapsible frame with struts and openings. The valve structure with leaflets is mounted inside the frame. The leaflets have separate flanges and cusp portions connected by reinforcing cords. The cusps flex around the struts while the flanges seal against the frame. This allows compact folding for catheter delivery. The valve expands inside the heart and the leaflets open. The separate flanges prevent leaflet extension through the frame during folding.

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Percutaneously implantable prosthetic heart valves that can be deployed through minimally invasive procedures. The valves use collapsible stents with docking structures that allow percutaneous delivery and expansion in the heart. The stents have flexible wires and posts that can be compressed for delivery on catheters, then expanded and rotated into position. Valves are attached to the stents with features to distribute stress for durability. The delivery systems allow retrieval and repositioning of partially deployed valves.

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Expandable prosthetic heart valve that is relatively simple to manufacture and deliver and that is suitable for operation within a designated range of working diameters. The valve includes an annular frame, which is movable between a radially expanded state and a radially compressed state. The valve includes at least one compliant actuator coupled to the annular frame, a proximal connector head, a distal connector base, and at least one extension spring.

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A heart valve prosthesis that can be implanted without open heart surgery. The prosthesis frame has supports extending from the native valve annulus upstream and downstream, connected by expandable arcs. The frame expands to clamp and anchor the native valve leaflets. This allows leaflet capture without resecting the native valve. The frame also has an expandable torus shape to push against the annulus. The expandable frame design enables percutaneous implantation through a catheter.

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Endoluminal support structures and prosthetic valves that can be compressed for delivery and expanded in place. The support structures have articulated joints connecting interlinked strut members. They can reversibly expand and compress between compact and expanded configurations. The joints allow compacting for delivery and then expanding to secure the device in place. The valve structures have commissure strut members with attached leaflets that form a shape suitable for a prosthetic valve.

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Expandable prosthetic heart valve with improved expansion and locking mechanisms for delivery, expansion, and implantation. The valve has an annular frame that self-expands from a compressed state, an actuator to radially expand and lock the valve, and a locking element. The actuator applies a proximally directed force to the frame to expand and lock it. The locking element continuously engages the actuator to prevent it from sliding back. This allows controlled expansion and locking of the valve without complex actuators or locking mechanisms. The valve self-expands then the actuator is pulled to tighten the locking element and prevent compression.

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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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Prosthetic heart valve with metal leaflets having pores instead of using biological leaflets. The valve has a collapsible stent, cuff, and metal leaflets that coapt to close the valve and pivot open. The leaflets are made of braided wire or mesh with pores instead of using biological tissue. This allows the valve to be durable and less prone to erosion compared to valves with biological leaflets.

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A delivery apparatus for an expandable prosthetic heart valve that allows precise control of the expansion forces and displacements of the valve when deploying it inside the body. The apparatus has multiple actuation shafts to expand the valve. These are connected through control mechanisms like pulley systems and gears to evenly distribute forces and allow independent movement. A multi-lumen shaft with helical lumens can keep the actuation shafts uniform when curved. This prevents uneven expansion and damage when navigating tortuous anatomy.

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Mechanically expandable prosthetic heart valve with controlled expansion, contraction, and locking capabilities. The valve has an actuator with parallel lumens, a locking member, and locking element. The actuator allows radial compression/expansion. The locking member can move axially to limit compression/expansion. The locking element adjustably couples to the locking member to lock the valve in expanded or compressed states. This provides predictable expansion/contraction and locked configurations. The valve also facilitates reliable attachment of the valve structure to the frame.

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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 collapsible prosthetic heart valve for replacing a mitral valve in the heart. The valve has a collapsible stent, a valve assembly, a flange and coupling tubes. The stent has a collapsed condition for delivery and an expanded condition for implantation. The valve assembly is inside the stent. The flange has braided wires and a flared portion. The coupling tubes connect the flange to the stent.

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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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A transcatheter prosthetic heart valve that can be side delivered through a small catheter and then expand once deployed in the heart. The valve has a compressible frame with anchoring tabs and a central flow component. The frame is compressed orthogonal to the catheter axis. After release, it expands to engage the native valve annulus. The tabs anchor the valve while the central portion allows unidirectional blood flow.

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

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A transcatheter prosthetic heart valve that can be delivered through a small catheter for minimally invasive valve replacement. The valve has a compressible frame that expands when released from the catheter. It has fixation elements on both ends that can extend through the native valve annulus before the valve is seated. This anchors the valve in place without increasing the compression size. The valve also has a flow control component to allow blood flow. The compressed valve diameter is smaller than the catheter diameter for transcatheter delivery.

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Simplified prosthetic heart valves that can be expanded after implantation to accommodate larger expandable prosthetic heart valves for valve-in-valve procedures. The expansion capability is achieved by incorporating two wireform frames, an upper one and a lower one, that can stretch apart slightly upon application of an outward dilatory force. The lower wireform has a shallow undulation that prevents excessive expansion. The upper wireform has inflow cusps and commissure posts while the lower wireform has truncated peaks between them. The wireforms permit limited expansion of the valve diameter upon dilation to receive a larger valve inside.

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Collapsible prosthetic heart valves with improved durability and resistance to wear. The valves have features to reduce abrasion between the leaflets and stent components. These include buffer strips on the stent struts that minimize contact with the leaflet edges when opened. The cuff material is a fabric and a second material that reduces leaflet-stent friction. The cuff is positioned so that leaflet edges open against the fabric rather than the stent.

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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 collapsible and expandable prosthetic heart valve with an improved skirt design to reduce leakage and enable better crimping for minimally invasive implantation. The skirt has an inflow edge secured to the frame, an outflow edge with alternating projections and notches, and an intermediate section with openings. The projections secure the skirt to the frame, while the notches allow some skirt retraction into the valve during compression. The skirt design allows uniform crimping without deforming the valve frame.

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Heart valve prosthesis with flexible leaflet and skirt components that can adapt to specific locations like the aorta. The prosthesis has a valve member with flexible leaflets and a valvular support structure, and an anchoring member with a flexible skirt. The leaflets and skirt can be made from materials like pericardium or bacterial cellulose. The skirt tapers conically like the valve member. This allows the prosthesis to conform to aortic geometry during implantation. The skirt and leaflets can be connected by sewing to prevent displacement. The skirt folds around the anchoring structure for fixation. A releasable connection between the valve and anchoring allows prosthesis replacement without removing the entire implant.

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Prosthetic heart valves with improved leaflet assembly and delivery methods that reduce leaflet deformation during implantation. The valves have frames that compress axially when radially compressed. The leaflets are attached with slack in the compressed state. When expanded, the frame elongates and the leaflets relax. This avoids overstretching the leaflets during delivery. The leaflets have unattached neck regions that allow relaxation. The necks stretch axially when compressed. The frames have discrete skirts sutured to the leaflet edges. The skirts extend beyond the leaflets and attach to frame struts. This provides leaflet support without axial compression.

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Prosthetic heart valve design with a collapsible commissure clamp to secure the leaflets together when the valve is closed. The collapsible commissure clamp has a wire-shaped member that can be bent into a desired shape. It attaches to the actuator component of the collapsible frame and holds the leaflet edges together at the commissures. This allows the leaflets to be folded compactly without adding bulk. The collapsible clamp deforms during assembly but returns to shape during valve operation to secure the leaflets.

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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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Heart valve design for minimally invasive replacement procedures that allows larger transcatheter valves to be implanted inside the original valve to reduce patient-prosthesis mismatch. The valve has an expandable frame section between the commissure posts that can enlarge when force is applied to expand the inner surface. This allows the implanted valve to be larger than the original valve diameter. The expandable section may have a weakened portion like a slit or cut that allows expansion.

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A two-step deployment method for prosthetic heart valves that allows for collapsible valves with fewer layers and a simpler design to be used. The method involves first implanting an expandable anchoring platform in the patient's heart. Then a separate expandable valve with interlocking features is deployed inside the anchored platform. The valve expands and locks into the platform to complete the implant. This sequential deployment allows for collapsible valves without multi-layer designs while still having secure anchoring.

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Prosthetic heart valve with a shortening, expanding frame and curved struts that allow it to collapse and expand radially without significantly increasing the implant size. The frame shortens when expanded, causing the curved struts to arch outward. This anchors the valve without adding bulk. The valve can be delivered collapsed and expanded in place. The curved struts also help prevent leakage and obstruction compared to flat-collapsing valves.

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An implantable prosthetic heart valve design that allows for minimally invasive transcatheter implantation through small incisions. The valve has a collapsible frame that can be crimped to a smaller diameter for delivery through a catheter, and expands once deployed inside the heart. The valve also has a skirt between the frame and leaflets to protect the leaflets during crimping. The skirt can be made of silicone to expand and stretch during crimping. This allows for smaller valve profiles that can be delivered through narrow catheter lumens.

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A prosthetic heart valve replacement device that can be delivered percutaneously to replace a native valve with a lower risk of complications compared to open-heart surgery. The device has a compressible valve frame with an outer frame that expands as the frame compresses. This allows the device to be delivered in a compressed state through a small incision, then expand at the native valve. The outer frame engages the native tissue to secure the device in place. Compressing the frame pulls the outer frame inward, increasing its amplitude. The device has a tool to transition it from compressed to expanded while retaining the frame. This expands the outer frame and moves it longitudinally to engage tissue.

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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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Valve replacement device for minimally invasive implantation in the heart that can replace a native heart valve like the mitral valve without open-heart surgery. The device collapses for transcatheter delivery into the heart and then expands to replace the native valve. It has a collapsible annular ring with pivot joints between segments. The ring expands to engage the native valve chordae tendineae, gathering them between the ring segments and anchors. This provides support while replacing the valve. The ring also has skirts to seat flush against the ventricle and atrium.

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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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A transcatheter mitral valve replacement system for treating mitral valve disease without open heart surgery. The system uses a collapsible prosthetic valve with a unique frame design to replace the mitral valve through a catheter. The frame has a stent part for radial strength and a wire mesh part for flexibility. The valve leaflets are attached to the frame. The mesh part helps the valve conform to the mitral annulus. The stent part forms the valve orifice. The system also has features to capture and stabilize the native mitral leaflets during valve deployment. This allows the new valve to replace the old one without prolapse or regurgitation. The valve is delivered retrograde through the left ventricle or antegrade through the left atrium.

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