Minimally Invasive Heart Valve Deployment

Catheter system for precise, sequential placement of prosthetic heart valves using a delivery catheter that allows controlled step-by-step expansion and release of the valve. The catheter has separate sleeves and a stent holder to retain the valve. It has a manipulator with a protrusion that unlocks and moves sleeves to release the valve in stages. This allows sequential expansion and detachment of the valve after insertion. The catheter also has features like alignment markers and springs to aid positioning and release.

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Delivering side-deliverable transcatheter prosthetic heart valves using supports and actuators to facilitate deployment into the native annulus. The delivery system has a control catheter and a removable supra-annular support. The valve is compressed and loaded in a catheter. At the target site, the valve is deployed and the supra-annular support transitions to stabilize the valve during seating in the annulus. This prevents the valve from collapsing or falling into the annulus. The control catheter is then detached. The supra-annular support can be a tether or rigid member. The support can be coupled to the valve at the proximal supra-annular region. The distal supra-annular region is fixed in the expanded valve configuration. This stabilizes the valve during deployment. The support can

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A sheath for delivering prosthetic devices like heart valves into the body that expands locally when a device is inserted and then collapses back to its original size afterwards. The sheath has an inner liner made of a spiral-wound sheet that can expand by sliding segments of the sheet past each other. An outer layer is bonded to the sheet. The local expansion allows larger devices to be passed through the sheath without excessive force or damage to blood vessels. The segmented spiral design allows controlled expansion and retraction.

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Balloon-expandable prosthetic heart valve that can be used for a variety of purposes, including prosthesis, cardiac, and heart surgery. The valve includes a stent, a cuff and a plurality of leaflets, the cuff and the plurality of leaflets forming a valve assembly, and a delivery device having an inner shaft and an expandable balloon transitionable between a deflated state and an inflated state, the delivery device having a hub with one or more receivers to accept the one or more retention tabs.

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A delivery system for implanting heart valves like mitral valves that enables less invasive and more efficient valve replacement procedures compared to traditional open-heart surgery. The system uses a reusable access sheath with interchangeable catheters that can be inserted through a small incision. The catheters carry the valve prosthesis components. A handle seals over the catheter exit to maintain hemostasis. The access sheath can be bent to navigate the heart anatomy. This reduces the number of catheters needed compared to multi-catheter systems. The reusable sheath and handle simplify the procedure compared to single-use catheter sets. The interchangeable catheter design allows customization for different valve sizes.

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Delivery system for implanting a prosthetic tricuspid valve to replace a diseased native tricuspid valve. The delivery system allows accessing the right atrium, bending the shaft to angles of up to 125 degrees and 30 degrees, and recapturing the valve after implantation. The system houses the valve in a crimped state in a capsule that engages the deployed valve. This allows evaluating valve function before release. The capsule bends with the valve to maintain contact. The shaft can bend in two planes.

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Minimally invasive implantation of prosthetic mitral valves to replace native mitral valves without open heart surgery. The prosthetic valves have compressible frames that can be delivered through catheters into the heart and then expand to capture the native mitral valve leaflets. The frames have ventricular anchors that extend outside the main body and can capture the leaflets. This allows secure fixation of the prosthetic valve without relying solely on radial friction. The compressible frames also reduce mitral regurgitation by reshaping the mitral annulus.

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A prosthetic mitral valve delivery system that allows easy and precise positioning and anchoring of the valve in the native anatomy. The delivery system has an outer sheath with a reduced diameter section. The prosthetic valve has an atrial skirt, ventricular skirt, and a tab connected to the ventricular skirt. When the outer sheath retracts, it releases the atrial and ventricular skirts to self-expand. Further retraction releases the tab tip to expand and form a window between the atrial skirt and tab tip. The tab base remains constrained. Additional retraction removes the base constraint, causing the tab tip to close the window. This sequential self-expansion and constraint release allows controlled positioning of the valve components. The system reduces the risk of valve misplacement and improves anchoring compared to collapsible valves that expand all at once.

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A folded, double-walled heart valve prosthesis that can be delivered through small catheters for transcatheter valve replacement. The valve has a unique folded design with an outer wall, inner wall, and transition region between them. The folded configuration allows compact delivery, and expanding the outer wall expands the inner wall to deploy the valve. The double-walled structure isolates valve geometry from the outer support. The folded design reduces valve size for delivery, allows separating valve geometry from the support, and provides structural integrity.

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Transcatheter valve delivery system that improves the TAVR procedure for a matched prosthetic valve design and has several design features that enable the precise placement and deployment of the prosthetic valve specially designed for the TAVR procedure. The system includes structural features to improve the TAVR procedure for a matched prosthetic valve design, including loading of the valve at the distal end of the catheter by reducing the diameter of the prosthetic valve from an expanded to a collapsed condition, and structure features that promote preferable folding and orientation of the valve leaflets when the prosthetic valve is reduced in diameter from the expanded configuration to the collapsed configuration as the valve is introduced into the distal end of the catheter.

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A prosthetic heart valve that can be delivered through less invasive percutaneous techniques by compressing or folding the valve during delivery then transitioning it to an expanded operating configuration once in place. The valve has a stent, leaflets, and a flexible sleeve connecting them. The valve can transform from a delivery configuration with the leaflets outside the stent to an operating configuration with the leaflets inside the stent by pushing the leaflets into the stent as the sleeve inverts. This allows a smaller delivery profile. The valve can be anchored by outward force on the native valve annulus when expanded.

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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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Catheter system for delivering prosthetic heart valves to mitral and tricuspid valves using anchoring devices to secure the valves in place. The delivery catheter has sections that bend around the native valve annulus to position the valve near the commissures. The catheter can also adjust height and angle to align with the annulus plane. This allows accurate placement of the anchoring device and valve without pushing the valve into the left atrium. The anchoring device forms a stable docking site for the valve. A sheath catheter system with nested housings is provided to enclose the delivery catheter.

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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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A transcatheter prosthetic mitral valve and delivery system for minimally invasive treatment of mitral valve insufficiency and stenosis. The prosthetic valve has a collapsible wire frame with a stent part and a mesh part that complement each other. The frame has features for conformation and anchoring. The leaflets are made of natural or synthetic materials that can switch between open and closed positions. The delivery system can access the mitral valve retrograde from the left ventricle or antegrade from the left atrium. The delivery system captures and immobilizes the native valve leaflets during deployment to stabilize the prosthetic valve at the ventricular level. The frame provides optimal apposition, sealing, and stabilization at the annulus and atrial floor.

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Heart valve replacement system for minimally invasive transcatheter replacement of diseased mitral valves without open heart surgery. The system uses a multi-stage, multi-lumen delivery catheter to guide and secure a prosthetic mitral valve in place. The delivery catheter has components like a docking sheath, valve chamber sheath, and locking catheter to precisely position the prosthesis. The prosthesis has a collapsible stent with fixation members implanted in the mitral annulus. The delivery catheter expands and releases the prosthesis over the fixation members. This prevents displacement and leakage. The system aims to address challenges like instability, paravalvular leakage, and LVOT occlusion in transcatheter mitral valve replacement.

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Delivering a valve prosthesis to replace a diseased native heart valve using a tethered anchor system. The anchor is deployed around the native valve chordae and leaflets. The tether extends through the native valve annulus and out of the heart. A guidewire is advanced through the native valve annulus and the anchor. The valve prosthesis is delivered over the guidewire and expanded inside the anchor and native valve. The tether is then released to allow the prosthetic valve to fully expand and secure in place. The anchor provides initial fixation while the prosthetic valve is deployed. The tether allows the anchor and prosthetic valve to be delivered separately and sequentially.

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Catheter system for transvascular implantation of prosthetic heart valves with self-expanding anchoring systems that can be implanted with minimal invasion and reduced risk to the patient. The catheter has a flexible, bendable distal section to navigate through the aorta without damaging the vessel walls. It also has a mechanism to retract the valve into the catheter if it is improperly positioned for repositioning rather than attempting to remove it.

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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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Delivery systems for implantable medical devices that enable accurate placement and orientation during deployment. The systems use visual markers on the devices and delivery shafts to provide alignment references during implantation. The markers can be seen in fluoroscopic images to verify proper device orientation. This allows visual confirmation that the device is properly aligned with the target anatomy, without needing radiography or other imaging modalities. The markers can be proximal and distal shaft markers, implant markers, or a combination.

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Preventing heart block after aortic valve replacement by modifying the valve design and implantation technique. The valve frame has a single recess aligned with the conduction tissue below the native valve to prevent contact. This reduces risk of heart block compared to full frames. A guide device helps center the valve during implantation. The guide is removed after implantation to avoid trapping. This ensures the valve doesn't impinge on the conduction tissue.

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Docking devices and prosthetic valves for treating heart valve problems like mitral regurgitation that have circular cross-sections to better match the non-circular native annulus shapes. The docking devices expand to create a more circular anchoring site for the prosthetic valve. They also constrict the native valve anatomy to reduce leakage. The docking devices have features like foam, woven textures, and radiopaque markers to optimize retention, tissue ingrowth, and imaging. Delivery systems have separate push and sleeve shafts to advance the docking devices without increasing outer diameter.

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A mitral valve replacement system that can be delivered and repositioned in a controlled manner using inverted deployable anchors. The valve prosthesis has expandable feet at the end of its frame, which can pivot from an inverted position to an expanded position upon release. The delivery instrument can collapse the anchors to the inverted position for crossing the native valve annulus, then extend them once past the annulus to anchor the valve subannularly. This controlled anchor deployment allows repositioning the valve if needed. The pivotable inverted anchors ensure secure attachment without damaging heart tissue.

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A delivery catheter for implantable medical devices with improved flexibility and lower profile for navigating through tortuous anatomy. The catheter has a braided shaft with an axial spine between inner and outer braid layers. The spine provides axial rigidity for push/pull forces, while the braided layers provide flexibility. The distal end has a capsule that can be actuated to expose the device. The capsule has a flexible region with delaminated jacket for increased flexibility. The lower profile, flexible catheter reduces trauma when delivering implants like stents and heart valves via minimally invasive procedures.

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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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Reducing contact between prosthetic heart valve apices and a delivery sheath during transcatheter delivery to minimize damage to the sheath and patient anatomy. The prosthetic valve has padding elements covering the distal valve apexes to prevent abrasion during delivery. The delivery device has a conical tip with a sliding cover that can be advanced distally to protect the valve apexes as they pass through the sheath. This prevents sheath degradation and reduces friction.

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A prosthetic heart valve assembly and delivery catheter that accurately deploy the valve without obstructing the heart anatomy and eliminating the need for post-surgery pacemakers. The valve mimics the natural heart valve shape with specific dimensions to avoid obstruction and maintain blood flow. The delivery catheter has components like a balloon, stoppers, and shaft to precisely position the valve during deployment. The catheter balloon expands the valve at the target location, and the stoppers ensure accurate placement. The valve's similar shape and the catheter's components enable precise implantation without complications.

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Accessory for compressing a transcatheter heart valve prosthesis without damaging the leaflets during crimping for delivery. The accessory has flexible guide fingers that contact the leaflets and hold them in a predetermined state during crimping. This prevents irregular folding and damage to the leaflets. The fingers are removed after crimping before encapsulating the valve in the delivery system. This allows the leaflets to fold into a compact shape with a smaller delivery profile.

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Minimally invasive system for delivering a prosthetic heart valve to replace a diseased mitral valve using a retrograde approach through the aortic valve. The system has a catheter with an articulating section that can flex for intravascular delivery and extend to angle the valve prosthesis towards the mitral valve. This allows navigating through the aortic valve and left ventricle before expanding the prosthetic valve in place.

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A delivery system for implanting prosthetic heart valves using a specialized catheter that allows precise and controlled deployment of the valve at the implantation site. The delivery system has a compressed prosthetic valve contained within a sheath that can be advanced through the vasculature to the target location. The valve is released from the sheath using a slideable release member that extends through suture loops attached to the valve. This prevents the valve from popping out prematurely during delivery. The valve can then be deployed by retracting the sheath while still secured by the sutures. The valve expands radially and the sutures are removed. The valve can also be recaptured by advancing the sheath back over the valve. This allows accurate deployment and retrieval of the valve without trauma.

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Transcatheter delivery of a two-part prosthetic mitral valve for implantation within the native mitral valve. The valve has an anchor assembly and a nested valve assembly that expand separately. The anchor engages the native annulus while the valve seals with the leaflets. The two-part design enables smaller delivery size through catheters. The valve parts are deployed in stages, first expanding the anchor then the valve inside it.

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Mitral valve prosthesis with a unique configuration that allows secure implantation and reduced risk of paravalvular leakage. The prosthesis has separate upper and lower supports that expand radially to engage the mitral annulus. A flexible connector connects the supports. The valve component expands inside the lower support to seal against the mitral annulus. This allows independent positioning of the supports before expanding the valve. It also allows the valve to be delivered compactly and expanded after placement. The flexible connector prevents paravalvular leakage by sealing around the valve.

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Catheter system for precisely delivering prosthetic heart valves with irregular shapes into patient anatomy. The catheter has two nested tubes, an outer sheath and an inner sheath with an anchor. The tubes have matching indices that allow them to rotate and translate independently. This allows adjusting the prosthetic valve angle while advancing it. The outer sheath moves axially to release the valve, separate from rotation. The catheter can deliver the folded valve through a puncture, rotate it in place, then extend it for implantation.

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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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Delivery system for catheter-based prosthetic heart valve implantation that enables precise and controlled deployment of the valve at the target site. The system has a delivery sheath with a tip section that facilitates directed expansion of the valve as it passes through. The tip section has features like alternating concave-convex curves or folding sections that guide and shape the valve expansion. This prevents sudden ejection of the valve from the sheath and allows controlled deployment at the desired location.

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A catheter-based system for retrieving and repositioning transcatheter prosthetic mitral valves from inside the heart. The system involves using a specialized catheter assembly to capture, collapse, and remove a previously implanted mitral valve through a transseptal approach. This enables percutaneous retrieval and repositioning of the mitral valve without open heart surgery. The catheter assembly has multiple catheters and a snare to invert and collapse the valve for retrieval through the catheter lumen.

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Artificial heart valve and delivery system that allows minimally invasive implantation with reduced profile for patients with difficult access. The artificial valve has an outer stent and detachable inner stent. During delivery, the inner stent is inside the outer stent. This allows the valve to be compressed for delivery through a small sheath. After implantation, the inner stent is released to expand the valve and anchor it in place. The detachable inner stent allows a smaller initial profile compared to a fully enclosed valve.

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Percutaneous transcatheter valve replacement for dysfunctional heart valves like the mitral, tricuspid, and aortic valves. The method involves using a specially designed prosthetic valve that can be everted to a compressed pre-deployment configuration to fit inside a catheter, then expanded to a deployed configuration once positioned at the valve annulus. The expanded valve is secured in place with tethers that pierce the surrounding tissue. This allows precise positioning and secure attachment without sutures or adhesives.

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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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Minimally invasive method for replacing both heart valves and aortic segments using a single delivery device. The technique involves delivering a balloon expandable conduit with a self-expanding prosthetic valve inside a collapsible balloon. The device is inserted through a blood vessel into the heart. The balloon is inflated to expand the conduit against the vessel wall. Then the valve is expanded within the native valve using a retraction sheath. The balloon is deflated and the delivery catheter removed, leaving the expanded conduit and valve in place. This allows simultaneous valve replacement and aortic repair through a minimally invasive transvascular approach.

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Reducing embolic complications during transcatheter aortic valve replacement (TAVR) by accessing the aortic valve through the carotid artery instead of the femoral artery. This involves percutaneous puncture or surgical cutdown of the carotid or subclavian artery, then inserting a specialized sheath into the artery to deliver the TAVR prosthetic valve. The sheath provides protection against embolic debris during the procedure by occluding the carotid artery and preventing debris release. The shorter, more direct access path through the carotid reduces the need for large, flexible delivery systems.

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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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Collapsible mitral valve replacement with separate atrial and ventricular portions that can be delivered separately and then cinched together after expansion to reduce delivery system size. The separate portions collapse into the delivery device with reduced radial overlap compared to collapsing in their final position. This allows a smaller device profile for delivery. The separate portions are deployed sequentially and then cinched together before final release from the device.

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Controlled delivery system and methods for implanting prosthetic heart valves like mitral valves. The delivery system allows compacted valves to be delivered percutaneously and then expanded in controlled stages to avoid tissue trauma. It uses a sequential restraint mechanism with nose cone, inner retention, tether, and outer elongate member that allows incremental expansion. The tether keeps the valve compact during removal of the outer member. Then the tether releases to expand the valve fully. This prevents contact with tissue during expansion.

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Two-stage prosthetic heart valve replacement system for quickly and easily replacing a heart valve while minimizing time on extracorporeal circulation. The system involves delivering a pre-expanded base stent to anchor against the valve annulus first, then a separate valve component with an expandable coupling stent that connects to the base stent. This allows faster initial anchoring compared to sutures, reducing extracorporeal circulation time. The valve component expands inside the pre-anchored base stent to join them and complete the valve implant.

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Delivery assembly for implanting transcatheter heart valves that allows tilting the valve relative to the delivery catheter to achieve coaxial alignment with the native annulus, even if the catheter is not fully coaxial. The assembly has an expandable valve with pivotable ends that can tilt relative to the catheter arms. This allows the valve to be positioned correctly even if the catheter is not perfectly aligned due to patient anatomy variations. The tilting mechanism allows the valve to be coaxial with the native annulus while the catheter is not.

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A new type of transcatheter prosthetic aortic valve system for transarterial implantation that addresses limitations of existing systems for treating aortic valve disease. The system has a folding positioning member that extends into the aortic root and anchors the valve in place. The positioning member has a bent end that extends toward the lower end of the valve stent. This provides strong anchoring and prevents valve displacement. The delivery system has a collapsible inner sheath that expands to contain the valve during deployment. This allows the valve to be delivered through a small catheter and expanded in place. The folding positioning member and delivery system enable transarterial implantation of the valve without requiring thoracotomy.

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Percutaneously implantable prosthetic mitral valve designed for secure fixation in the native mitral valve anatomy, ease of deployment and ability to be repositioned. The valve has separate anchor and valve components that can be deployed independently. The anchor expands to engage sub-annular tissue and stabilize the valve, while the valve attaches to the anchor and replaces the native valve function. The valve and anchor can be separately mounted to a delivery catheter system.

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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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Transcatheter delivery system for implanting prosthetic heart valves like mitral valves. The system has multiple catheters that can slide and lock together. It also has a frame with clamps to hold the catheters. The frame can translate and rotate to separately deploy the anchor and valve components of the prosthetic valve. This allows staged deployment of the valve components through a smaller delivery system. The frame controls the relative movements of the catheters to accurately position the valve components for implantation.

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