Valve-in-Valve Implantation for Heart Valve Replacement

Delivery systems for prosthetic heart valves and methods to deliver and deploy them in the body. The systems have features like compactable tethers, retention mechanisms, and controllable deflection to facilitate implantation through narrow access points. The prosthetic valves themselves have features like expandable frames, retention tethers, and disintegration assemblies to aid implantation and securement. The delivery systems also have features like deflection actuators, pull tethers, and spacer bodies to enable controlled deployment in complex anatomies.

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A transcatheter valve prosthesis and implantation method to replace a native heart valve like the mitral or tricuspid valve. The prosthesis has a tubular body with a prosthetic valve and a fabric covering. It's delivered catheterically to the native valve location. Instead of removing the native valve, the prosthesis partially deploys to engage the native leaflets. Then it's fully deployed to lift the native leaflets and avoid obstruction. This allows natural blood flow through the ventricle. The fabric-covered tubular body replaces valve function without obstructing.

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Implanting a prosthetic valve within a native valve for replacing a calcified native heart valve. The prosthetic valve includes a support structure for deployment on an upstream side of the native valve and including an atrial anchor forming a ring about the flow channel.

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Prosthetic heart valves that can be accurately positioned within existing implanted valves using percutaneous techniques. The valves have radiopaque markers that can be visualized outside the body to identify valve size, position, and depth after implantation. The markers aid in optimal placement, reducing the risk of coronary artery obstruction and enabling multiple valve stacking if needed.

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Safe and controlled replacement of heart valves using expandable prosthetic valves that can be precisely delivered and secured in place. The method involves expanding the prosthetic valve inside a support structure positioned on the native valve. This frictionally secures the leaflets between the support and prosthetic valves. The support structure can be delivered separately or as part of the prosthetic valve delivery catheter. The support structure is expandable and can have features like peaks that align with native valve leaflet tips to facilitate securement. This prevents the prosthetic valve from ejecting quickly and allows precise positioning. It also prevents further valve dilatation. The support structure is later disconnected from the delivery catheter once secured.

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A replacement heart valve system that enables compact delivery and customizable expansion while anchoring securely to the native valve tissue. The system uses a collapsible adapter that attaches to the native valve and provides a sealing portion. The replacement valve itself is a flexible frame optimized for sealing and fixation. The adapter and replacement valve can be delivered separately or together. The adaptive frame allows compact delivery via catheters and expands to fit the heart. The adapter anchors supra-annularly, sub-annularly, and radially. The replacement valve can be removed and replaced. The system aims to improve heart valve intervention outcomes by allowing retrievability, directional flow, and native valve compatibility.

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A expandable prosthetic heart valve designed to securely anchor in a native mitral valve annulus without impeding blood flow to the left ventricular outflow tract. The valve has an inner stent, valve assembly, outer stent, and tether. The outer stent folds into a double-walled flange that engages the atrial surface of the native annulus. A sealing cuff on the flange prevents leaks. The tether anchors the valve to the heart wall. This allows the valve to expand without extending into the ventricle. The folded flange reduces profile for delivery.

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A prosthetic mitral valve system for reducing regurgitation and avoiding obstruction issues when implanted without removing the native valve. The system has separate expandable anchor and valve components that engage the native mitral valve. A containment member on the anchor restricts anterior leaflet movement to prevent it from obstructing the outflow tract. This prevents the leaflet from being pulled into the outflow tract by pressure differential during systole, which can cause obstruction. The containment member can be angled beyond the leaflet to further prevent retraction. The separate expandable components allow independent positioning and adjustment for optimal mitral valve replacement without obstructing the outflow tract.

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A delivery system for percutaneous implantation of a prosthetic heart valve. The system allows controlled and precise deployment of a self-expanding valve from a sheath using rotational movement instead of push-pull forces that can cause uncontrolled valve jumping. The valve is connected to a torque shaft catheter that can be rotated to unsheathe and expand the valve in a controlled manner. The system also has releasable mechanisms to disconnect the valve from the catheter after deployment.

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A compact, easy-to-handle percutaneous valve delivery system for implanting prosthetic heart valves through minimally invasive procedures. The system uses a balloon expandable prosthetic valve mounted on a single balloon with differential inflation. The balloon has a distal section, middle section, and proximal section. Inflation starts with the distal section, then the middle section, and finally the proximal section. This staged inflation allows precise placement and retrievability of the valve across the native valve annulus. The compact design avoids obstruction of the coronary arteries and simplifies handling compared to conventional two-balloon systems.

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Interventional artificial heart valve that reduces blood regurgitation and mitigates complications compared to existing devices. The valve has a collapsible stent with artificial leaflets, covered by a blood-absorbing annular seal. The seal expands after absorbing blood to secure the valve in place. The stent also has connecting elements to attach an anchoring section that fixes the valve. The anchoring section has elasticity and attaches to the native valve annulus. This improves stability and reduces leakage compared to prior devices that just compress and expand the valve stent.

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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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A transcatheter heart valve replacement with adjustable regurgitation control. The valve has a compressible frame that allows delivery through a small catheter. It has inner and outer flow control components, with the outer component having a compressible wire cell. The frame can be compressed for delivery and expands in place. The wire cell allows backflow adjustment by cutting an opening in the tissue cover. This allows intentional regurgitation to match native valve function. The valve can be delivered orthogonally through major blood vessels.

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A method for replacing native heart valves with prosthetic valves that can be used to treat conditions like aortic insufficiency where the native valve has soft leaflets that can't securely anchor a balloon-expandable prosthetic valve. The method involves delivering a support structure like a stent or band to the native valve location and expanding it. Then, a prosthetic valve is delivered into the support structure and expanded to secure the native leaflets between them. This allows the prosthetic valve to be accurately positioned and anchored without compressing the native valve. The support structure is later disconnected from the delivery catheter.

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A prosthetic heart valve assembly that aims to reduce complications and improve outcomes from heart valve replacement procedures. The assembly has a unique prosthetic heart valve design that closely matches the size and shape of a native valve. This reduces obstruction of blood flow and avoids issues like conduction disturbances and coronary occlusions. The assembly also uses a specialized dispensing catheter with features like uniform radial expansion and linear valve positioning to prevent embolization and occlusions. The goal is to provide a more accurate, efficient, and safer replacement heart valve implantation procedure.

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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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Prosthetic heart valve that can be moved to an inverted configuration for delivery of the prosthetic valve to within a patient's heart. The prosthetic valve includes an outer frame that can be inverted relative to an inner frame when the prosthetic valve is in a biased expanded configuration. This allows the valve to be collapsed for delivery in a sheath, then expanded in the heart.

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Minimally invasive method and device for delivering and expanding prosthetic heart valves through the vasculature without fully occluding the lumen during expansion. The device has an expandable frame with movable distal and proximal ends that can be configured to separate and then join together. When the ends are separated, the frame expands radially outwards to deliver and expand the prosthetic valve without fully occluding the lumen. This reduces blockage during implantation compared to expanding a balloon to deliver the valve.

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

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A prosthetic heart valve design that allows precise and repeatable placement during minimally invasive procedures. The valve has a radiopaque element around the base that can be easily identified using X-rays to accurately position the valve inside the heart. This helps avoid issues like misplacement or regurgitation that can occur with conventional valves. The valve also has commissure posts and a stent structure that allow multiple valves to be stacked on top of each other for repeat implantation in the same location. The radiopaque base enables visual confirmation of valve stacking depth.

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Steerable catheter system for delivering prosthetic heart valves to replace native valves. The system has a flexible delivery sleeve with a section that can be steered by a pull wire. The valve is mounted on a balloon catheter inside the sleeve. The wire can bend the steerable section to navigate curves like the aortic arch. After delivery, the wire releases and the sleeve straightens. This allows advancing the valve through tight areas. The valve can be deployed by inflating the balloon.

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Modular valve replacement system for minimally invasive heart valve replacement using separate catheter deliveries to reduce device size. The system involves a fixation device implanted first to anchor in place, then a separate permanent valve assembly attached later. The fixation device has an expandable frame with a tissue-fitting portion to secure it in the heart. The permanent valve has a detachable support with an artificial valve. This allows delivering the smaller fixation device initially, then connecting the larger permanent valve assembly afterwards. The fixation device can also have a temporary valve to prevent leakage before the permanent valve is attached.

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Delivering and securing expandable prosthetic heart valves in patients with native valves that don't have calcified leaflets. The method involves using a support structure like a stent or band to frictionally secure the native valve leaflets between the support and the prosthetic valve. This prevents the prosthetic valve from ejecting rapidly from the delivery catheter and helps prevent valve dilatation. The support structure is delivered first to the valve site, then the prosthetic valve is advanced into it. The support is disconnected once the native leaflets are secured. This allows precise, controlled delivery of the prosthetic valve without compressing it during catheterization.

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Prosthetic heart valve replacement system for mitral valve regurgitation that uses a multi-stage, multi-lumen delivery system to secure the valve in place. The valve has a stent with flared annular and ventricular portions. Dual guiding and fixation (DGF) members attach to the annulus. The ventricular portion displaces native leaflets. The stent has prosthetic leaflets. Locking devices fixate the valve. The delivery system stages the components for implantation.

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A mitral valve implanted in the left atrium above the native valve using a transcatheter method to address stability issues during heart movement. The valve is positioned higher than the native valve structures to prevent obstruction of the left ventricular outflow tract. This allows the valve to remain stable during heart motion instead of relying on direct attachment to the native valve structures. The valve also uses ligaments to prevent prolapse and severed chordae tendineae to allow the leaflets to close properly.

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Prosthetic devices and methods for sealing native heart valves and preventing regurgitation. The devices are implanted onto the leaflets of a native valve to augment coaptation and reduce leakage. They can be delivered using catheters and rails. Some devices expand to fill gaps between the leaflets. Others have fasteners to secure them to the leaflets. Inflatable bodies can anchor the prosthetic valve in place. The devices can be delivered using steerable catheters and rails to position them accurately.

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Implanting a secondary prosthetic heart valve within an existing deteriorating implanted valve to restore function without disrupting the original valve. The secondary valve is positioned in series or offset relative to the primary valve. It expands within the existing valve using a balloon catheter to avoid interacting with the ventricular portion. The secondary valve has tethers anchoring it to the heart wall. This allows replacement of failing implanted valves without removing the original one, extending valve longevity.

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Delivery system and prosthetic heart valve design to enable precise and controlled deployment of self-expanding valves in the heart. The delivery system allows controlled expansion of the valve from the sheath to prevent jumping out during implantation. The valve has a curved stent shape with reduced diameter at the annulus and flared ends to retain in place. The delivery apparatus has a rotatable shaft that moves the sheath relative to the valve to expand. A retaining mechanism secures the valve after expansion for adjustment. The sheath design allows unsheathing by moving the sheath relative to the catheter.

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Percutaneous valve replacement system for minimally invasive heart and vascular valve replacement. The system uses a catheter with a retractable sheath to deliver a deformable prosthetic valve. The valve is initially in a long, cylindrical shape inside the sheath. When the sheath retracts, the valve deforms into an arcuate shape ready for implantation. This allows partial or complete valve replacement in a stepwise fashion using percutaneous access.

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Transcatheter delivery system for implanting prosthetic heart valves that can close a septal hole left after delivery. The system has a compressible delivery sleeve, shaft, and tip assembly. The prosthetic valve is loaded inside the sleeve. During delivery, the tip compresses for passage through the hole. After valve implantation, the tip expands to occlude the hole. This avoids leaving a large hole and allows removing the delivery components without reopening the heart.

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Delivery system for implanting a prosthetic heart valve without using a guide sheath. The system has a delivery sleeve, valve catheter, and prosthetic valve. The valve catheter slides inside the sleeve and has a mechanism to release the valve. The sleeve is retracted to expose the valve, then the valve is released. This allows advancing the valve without a separate guide, easing tracking through curved vessels and reducing displacement of plaque. The catheter can also have a balloon for dilating the native valve. A lead screw retracts the sleeve after exposure.

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A delivery system for collapsible heart valves that allows precise and controlled deployment of the valve inside a patient's heart. The system has a catheter with an enclosed compartment to hold the collapsed valve, and an operating handle with dual lead screws. One screw moves the valve partially out of the compartment, the other fully deploys it. The screws can be separately operated or simultaneously rotated. This allows staged deployment with intermediate expansion for better positioning before full expansion. The handle design enables more controlled and accurate valve deployment compared to traditional systems with single screws.

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Transcatheter stent valve design to mitigate leakage around the implanted valve without increasing valve size. The valve has a seal that can be compressed during delivery and expands after implantation. The seal is supported by a shape memory material that helps it conform to the irregular tissue contours without penetrating. This prevents gaps and leaks around the valve when the natural tissue is not perfectly circular. The seal can be made of flexible materials like natural tissue or synthetic films.

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Prosthetic heart valve designed to be expandable from within in order to receive a replacement prosthetic valve. The valve has a structure that can be dilated using a balloon catheter, allowing it to expand to a larger diameter. This enables a second replacement valve to later be implanted inside. The expandable valve has a composite support ring with flexible segments that can stretch when dilated. This allows it to transform from a rigid configuration to an expanded configuration to accommodate the replacement valve.

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A low profile, side delivered, implantable prosthetic heart valve that can be delivered using a catheter through a small incision rather than open heart surgery. The valve has a compressible frame that can be expanded after delivery. It also has a flow control component with leaflets and a tension arm for anchoring. The side delivery approach avoids perforating the heart and reduces trauma compared to transapical valves. The valve can be delivered through a catheter inserted into the atrium and expanded in place.

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A system for repairing heart valves using an adjustable implant that can be delivered non-invasively. The implant has an expandable artificial valve to replace a defective valve, and an anchor to fix it in place. The anchor can be adjusted to fine-tune the distance between the valve and the anchor. This allows customization of the implant position after deployment. The implant is delivered through a catheter to the heart, where the valve is expanded and suspended in the native valve opening. The anchor is then fixed to the heart tissue nearby. The adjustable length feature allows optimizing the valve-anchor distance without requiring a second procedure.

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Prosthetic heart valve that can be delivered percutaneously and expand inside the native valve to secure it in place. The valve has an expandable tubular frame, fixed outer frame, and moveable upstream support. Compressing the tubular frame reduces its diameter and length, but expands the outer frame and moves the legs upwards. This allows the valve to be delivered compactly, then expand and sandwich the native valve tissue.

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Catheter-based prosthetic heart valves with collapsible frames that minimize trauma and risks associated with implantation compared to open-chest surgery. The valves have leaflet structures with commissures attached to inwardly protruding posts or struts on the frame. This allows the leaflets to open with the movable portions spaced inwardly from the frame to prevent abrasion. The frame collapses for delivery and expands in place. The inwardly mounted commissures reduce valve size for easier catheter delivery and minimize leaflet-frame contact during valve operation.

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Reducing the French size of catheters used to deliver transcatheter heart valves by loading the valve in an inverted orientation inside the stent, then pulling it through to transpose it during deployment. The valve is connected to the stent proximal end in the inverted position. After partial stent expansion, the valve is pulled through the stent lumen using cables to transpose it from inverted to deployed orientation. This reduces the thickness of the loaded valve assembly for smaller catheter sizes.

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Minimally invasive procedure to replace a heart valve without open heart surgery. The procedure involves implanting a prosthetic valve into the aortic annulus through a puncture in the left ventricle wall, without stopping the heart. A balloon catheter with a crimped valve is inserted through an introducer sheath into the left ventricle. The valve is expanded at the aortic annulus using the balloon. This allows valve replacement without opening the chest or using cardiopulmonary bypass.

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A hybrid prosthetic heart valve that can be implanted more quickly and efficiently than traditional valves. The valve has an expandable metallic skirt that mechanically connects to the native valve annulus. A delivery system with a locking mechanism prevents premature deployment. The valve can be delivered through a smaller incision since the skirt expands in place instead of needing sutures. This reduces morbidity and mortality compared to open-heart surgery. The system also has a balloon catheter for expanding the skirt. The balloon locks in place until ready to deploy, preventing accidental expansion during delivery.

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Minimally invasive artificial heart valve system and method for replacing natural valves like mitral valves that have irregular shapes and are difficult to replace with conventional aortic valve prosthetics. The artificial valve has a deformable support that expands after implantation to match the irregular valve annulus. It also has a fixation member that can be deformed to engage surrounding tissue. This allows the valve to be delivered compressed then expand in place. An indicator portion deflects during implantation to guide positioning. The valve can also have a separate expandable frame that deforms while the fixation member stays folded.

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Minimally invasive delivery system for implanting prosthetic heart valves using a transseptal approach. The system involves a guide member assembly that can be advanced into the heart through the septum and docked at the native mitral valve. A collapsed prosthetic valve is then advanced over the docked guide member and deployed at the implantation site. The guide member is removed after docking, allowing the valve to be precisely positioned and oriented for implantation. This reduces the difficulty and risks of aligning the valve in the confined space of the left atrium during transseptal delivery.

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A percutaneously deliverable heart valve that can be implanted using a catheter to replace diseased valves without open surgery. The valve has a collapsible frame with dry, thin, treated pericardial tissue leaflets. The leaflets are prepared by fixing the tissue with glutaraldehyde and glycerol, then drying it. This allows a low profile valve that can be packed and delivered dry without a preservative solution. The valve is mounted on a catheter balloon for insertion. The dry valve reduces profile compared to hydrated valves, simplifying delivery through small catheter sizes.

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A prosthetic heart valve designed to allow replacement of a native valve using a traditional valve, then later replacing that valve with an expandable prosthetic valve without compromising blood flow. The valve has a support structure that is initially rigid to implant like a regular valve, but can expand radially when subjected to higher pressures. This allows a new expandable valve to be deployed inside the expanded original valve without obstructing blood flow. The expanded valve has weakened sections that fail at higher pressures, causing expansion.

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An interventional artificial heart valve that can be implanted percutaneously and easily recovered. The valve has a recoverable design that allows it to be fully retrieved and repositioned if needed during implantation, unlike conventional irreversibly expanded valves. The valve has a deformable frame that compresses for delivery and expands in the body. The valve leaflets and cover are made of biocompatible materials. The frame has openings for coronary arteries. The valve is designed to avoid friction between the frame and leaflets. The recoverable valve allows accurate placement and size adjustment without the risks and limitations of irreversible valves.

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Method for implanting a smaller prosthetic heart valve, like a mitral valve, with reduced axial length that can be delivered into the heart with less trauma and protrusion compared to larger valves. The method involves releasing ventricular and atrial anchors within the atrium, then moving the ventricular anchors through the mitral valve into the ventricle, and finally expanding the valve body to anchor it between the ventricular and atrial anchors. This allows the valve to be implanted with a smaller delivery profile, then expanded in place to secure it without protruding into the chambers.

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Minimally invasive heart valve replacement without open chest surgery. The method involves accessing the heart through small incisions, resecting the diseased valve using expandable devices, and implanting a new valve via the same access points. This allows valve replacement without the need for extracorporeal bypass or sternotomy. The access devices seal against the heart wall to prevent bleeding.

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A prosthetic heart valve that can be collapsed to a smaller diameter for delivery and then expanded to a larger diameter after implantation. The valve has a stent frame and a valve support that can invert within the stent frame. When inverted, the two structures overlap to reduce the overall diameter. This allows the valve to be compressed to a smaller size for delivery through a catheter, then expanded to full size after implantation.

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Minimally invasive delivery system and technique for implanting a mitral valve prosthesis to replace a diseased mitral valve. The prosthesis has an expandable anchoring element and a separate expandable valve component that can be delivered separately and assembled in the native valve annulus. The delivery system has two sheaths, one for the anchoring element and one for the valve component. The anchoring element is released first and expanded in the atrium, then the valve component is released and expanded in the annulus. This allows precise positioning and anchoring of the prosthesis without compressing it during delivery.

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