Reinforcing Prosthetic Heart Valve Leaflets: Innovations in Durability

Transcatheter-delivered prosthetic tricuspid heart valves that can be deployed via catheters to replace sub-optimally functioning native tricuspid valves. The prosthetic valves have features to anchor them securely in the tricuspid anatomy, including flaps and arms to engage surrounding structures. This mitigates migration. The valves also have shaped leaflets and occluders to improve sealing and reduce paravalvular leakage. The deployment catheter systems have curved inner catheters to navigate the tricuspid anatomy via the vena cavas.

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Prosthetic heart valve with adjustable commissure supports that allow the valve to be expanded to a wide range of diameters while maintaining proper leaflet coaptation. The commissure supports have adjustable arms that can be rotated or twisted to adjust the tension on the attached leaflets. This allows customizing the valve diameter for each patient by adjusting the commissure support arms to match the expansion diameter of the valve frame. A delivery assembly allows in-situ adjustment of the commissure supports after valve implantation.

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Prosthetic heart valve leaflet assembly with asymmetrical leaflets and commissure assembly configurations to improve durability and reduce wear compared to conventional symmetrical leaflet designs. The leaflets have tabs with vertical extensions that fold over adjacent leaflet tabs to form commissures.

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Leaflet assembly techniques for prosthetic heart valves. It involves attaching the leaflets to the frame by passing their tabs through windows in the frame and then securing them in place. The tabs have upper and lower portions separated by a gap. This allows the tabs to be inserted through the frame windows. Once inserted, the tabs are folded over and stitched together. The leaflets cannot pass back through the windows due to the gap between the upper and lower tab portions.

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Method of assembling prosthetic heart valves with improved leaflet attachment using buckle clamps. The assembly method involves pre-assembling the leaflets by wrapping their tabs around buckle clamps. The preassembled leaflet/clamp units are then attached to the valve frame. This improves attachment compared to directly suturing leaflet tabs to the frame.

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Prosthetic heart valve with restraining posts that prevent unwanted rotation or movement of the leaflet commissure assembly during crimping and expansion of the valve. The posts have protrusions that engage the commissure tabs to limit axial motion. The commissure tabs wrap around the posts in opposing directions. This provides a secure and self-aligning attachment of the leaflets to the frame, reducing the risk of detachment or misalignment during deployment.

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Prosthetic heart valve having increased effective flow area for a given valve size, with wireform and flexible leaflet structure modifications. The valve has an undulating wireform/stent covered in cloth with cusps and commissures. Flexible leaflets attach between the cusps and around the commissures. To increase orifice area, the leaflets extend over the cusps and/or commissures of the wireform. This allows larger leaflet coaptation area compared to traditional heart valves, increasing effective flow area for a given valve size.

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Improved attachment mechanisms for prosthetic heart valves that reduces stress concentrations, abrasion, and stretching of the valve leaflets compared to conventional attachment techniques. The attachments allow the leaflets to move more freely relative to the frame during expansion and contraction. One mechanism involves suturing the leaflet scalloped edges to struts perpendicular to the scallop line, allowing sliding movement. Another mechanism uses a separate flexible element to connect the scalloped edge to the frame.

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A durable transcatheter prosthetic heart valve that avoids calcification and degradation issues of existing prosthetic valves. The valve has optimized leaflet and stent designs, woven attachment to the stent, and reinforcements. The leaflets are thermoformed from polymer material into an optimized shape. The leaflets weave through the stent frame to anchor in place. This prevents shearing forces that can damage fixed-edge valves. Fibers or other reinforcements are added to enhance valve durability.

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Prosthetic heart valve made from a composite material containing fibrous reinforcements that resist calcification and tearing. The valve leaflet includes electrospun fibers embedded in a polymer matrix. The fibers can be composed of different materials to provide tailored physical and mechanical properties. The polymer matrix can be a polyisobutylene urethane copolymer for chemical inertness.

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Composite leaflet material for artificial heart valves that have improved durability and reduced wrinkling compared to conventional materials. The composite material is formed by combining an expanded fluoropolymer membrane with an elastomer. The elastomer fills the pores of the expanded fluoropolymer. The composite leaflets made from this material exhibit elongation while maintaining strength and then increase in stiffness beyond a certain strain. This provides flexibility during valve opening without excessive wrinkling, and resistance to tearing or failure during long-term cyclic operation.

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Prosthetic heart valve design with collapsible leaflets that can be delivered via a catheter. The valve has an expandable stent frame and flexible leaflets that can collapse for delivery, then re-expand once deployed in the heart. The leaflets are secured to the stent frame and have features to prevent damage from abrasion. The valve design enables less invasive delivery compared to traditional open-heart surgery.

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Highly durable synthetic flexible leaflet prosthetic heart valve design that prevents premature failure. The valve uses a composite leaflet material with an expanded fluoropolymer membrane and an elastomeric material. It also has a unique leaflet shape with an isosceles trapezoid attachment zone on the frame. The composite material and shape prevent leaflet delamination and tearing. The valve has two frames, a nested leaflet frame and an outer frame, to provide structural support and prevent leakage. It can be delivered via transcatheter or surgical methods.

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Manufacturing prosthetic heart valves with artificial polymeric leaflets that aims at improving the manufacturability and consistency of these valves. The manufacturing involves applying a liquid polymer to the valve frame and a leaflet formation structure, partially curing the polymer in a humidity chamber, then fully curing it in another chamber. This allows the thickness of the leaflets to be precisely controlled. An identifier is marked on the valve frame to track and optimize the manufacturing process.

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