Breakthroughs in Precision and Retrieval for Heart Valve Implants

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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Recapturing of partially deployed prosthetic heart valves in a minimally invasive manner during transcatheter valve deployment procedures. The catheter has a recapture funnel that can be used to retract a partially deployed prosthetic heart valve back into the delivery sheath. The funnel is advanced over the protruding valve skirt, inverts it back into the sheath, and then collapses to capture it for retrieval.

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Transcatheter delivery system for deploying a self-expanding prosthetic heart valve. The system has an inner steerable catheter and an outer steerable catheter with independent flexing and rotation. The inner catheter has a distal section with a flex pattern that curls when tensioned. The outer catheter has a distal section with a different flex pattern that also curls when tensioned. The inner catheter can flex and rotate inside the outer catheter. This allows the delivery system to navigate tortuous anatomy while delivering a collapsed heart valve without a capsule. The independent flexing and rotation of the inner and outer catheters provide flexible but strong and controllable delivery performance.

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Low-profile delivery system for collapsing, maintaining, delivering, deploying, repositioning, and retrieving collapsible/expandable prosthetic heart valves. The system uses a modular design with multiple components that slide over each other to expand, deploy and retrieve the valve. The valve is collapsed around a central shaft and covered by two sheaths. Moving the sheaths uncovers and expands the valve. The modular components allow flexibility in deploying the valve's ends in different orders for optimal positioning.

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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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Packaging design for prosthetic heart valves that securely retains the valve within a jar and facilitates retrieval therefrom. The packaging assembly includes a jar, a prosthetic heart valve, a valve holder, and a packaging sleeve. The sleeve fits closely within the jar and has a clip structure for securing the valve holder. This allows the valve assembly to be packaged with the valve inverted. A shaft can then be inserted through the valve to attach to the holder and lift the valve out of the jar for implantation.

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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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Prosthetic heart valve that can be used for transcatheter delivery and placement to replace damaged mitral valves. The prosthetic valve has features to aid delivery and positioning. It includes an anchoring tether coupling portion to secure a tether that attaches the valve to the heart wall. The tether maintains valve position. The coupling portion can also engage with a positioning device to help position the valve during delivery.

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Device for accurately positioning a prosthetic heart valve during minimally-invasive transvascular implantation to improve outcomes over prior techniques. The device includes a self-expanding stent that can be inserted into the patient's aortic valve to define a precise position and alignment for the prosthetic valve. A separate self-expanding stent with the prosthetic valve is then inserted into the artery. When the stents expand, they interlock to fix the prosthetic valve in the predetermined position set by the aortic stent. This ensures accurate angular alignment and reduces risk of malpositioning.

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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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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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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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An expandable introducer sheath for minimally invasive delivery of medical implants like prosthetic heart valves. The sheath can temporarily expand and contract to accommodate larger devices while minimizing vessel trauma during insertion. The sheath has alternating sections of stiff material and elastic material that allows expansion without buckling. The expandable sheath can also have reinforcing layers like braided fibers or a stent for added strength. The variable stiffness of the alternating sections enables temporary diameter expansion to fit the implant and then returning to the original profile after passage. This provides a minimally invasive delivery system that reduces vessel tearing and plaque dislodgement compared to fixed diameter sheaths.

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Delivery system for transfemoral delivery of collapsible prosthetic heart valves that can be re-collapsed if necessary. The delivery system has a flexible catheter with a reinforced tubular member made of helically wound metal strands. The strands are joined together and/or coated with polymer to prevent sliding and maintain dimensional stability under load. This allows safe transmission of high forces to re-collapse the valve if needed. The re-expandable valve can be partially collapsed if repositioning or removal is required.

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Enhanced cardiac imaging and navigation for transcatheter heart valve procedures. The technique involves using a small electrophysiological 3D mapping catheter to create a detailed 3D map of the heart. This map is displayed in real-time during the procedure along with other imaging modalities like echocardiography or fluoroscopy. The combined imaging provides enhanced visualization for accurate positioning and deployment of transcatheter heart valves.

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