Polymer and Tissue Valves for Prosthetic Hearts

Prosthetic heart valve design with improved stress isolation and leaflet durability in transcatheter valve replacement procedures. The valve has patches attached to the commissure attachment features of the stent to absorb forces during valve operation. The patches can be rigid or billowing to provide stress isolation. This reduces mechanical stresses on the leaflet tissue, especially in cobalt-chromium stents where the leaflets are coupled directly to the stent. The patches are disposed around the commissure features and the leaflets are attached to the patches instead of the stent.

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Heart valve prosthesis design to reduce complications and improve durability compared to conventional valve replacements. The prosthesis has an inner stent with a thin channel for the valve leaflets and a thick channel. An outer cylindrical stent surrounds the inner stent. The top of the outer stent is sutured to the thin channel and the bottom to the thick channel, creating a sealed cavity between. This prevents false lumens and thrombosis. The outer stent buffering prevents channel compression by heart contraction. An inward depression covered by a brim in the outer stent avoids contact with native tissues like the conduction system and outflow tract.

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A prosthetic heart valve for replacing native atrioventricular valves, like the tricuspid and mitral valves, that can collapse to a small size for transcatheter delivery and expand in place. The valve has a self-expanding stent with an inner frame for the leaflets and an outer frame. A non-stretchable fabric seals the atrial side and a stretchable fabric seals the ventricular side. This allows the valve to collapse into a catheter with an inner diameter of 22-32 French. The small profile enables minimally invasive transcatheter delivery through small access sites. The valve expands in place to cover the native valve annulus without pressing against it. The outer fabrics provide sealing contact.

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Replacement heart valves made from a single molded sheet of collagen-based biomaterial that integrates the leaflets and body portion. The valves have fewer sutures than conventional valves since the leaflets and body are formed together. The valves are inserted into a stent and secured with fewer sutures compared to traditional valves. The molding process allows shaping the leaflets with concavities and variations in thickness. The valves have improved efficiency and cost compared to hand-sewn valves with separate leaflets and body pieces.

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Artificial heart valve made of polymer material that opens and closes naturally like a natural heart valve. The polymer leaflets are arranged in a configuration that allows the valve to be in an open position in its natural state. This eliminates the need for anticoagulant drugs and reduces the risk of bleeding compared to mechanical valves. The polymer leaflets have a curved shape with different upper curves to prevent premature closure. This allows the leaflets to deform and open more easily with blood flow compared to flat polymer valves.

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A three leaflet prosthetic heart valve for percutaneous valve replacement procedures that aims to provide a durable, anticoagulation-free alternative to mechanical and bioprosthetic valves. The valve has a unique leaflet design where the upper portion of the leaflet material wraps around the inner surface of the stent frame and folds over, allowing the upper portion to move within the stent frame. This design eliminates the need for a separate annular skirt or sewing ring, simplifying manufacturing and reducing the risk of leakage. The leaflet material can be a continuous sheet or multiple pieces, and can be made of polymeric materials like polyethylene or polyurethane. The three-dimensional curvature of the leaflets mimics natural valves and allows them to open and close like a natural valve.

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Prosthetic heart valves for transcatheter implantation with improved performance and durability. The valves have a unique leaflet shape to reduce stress and improve function, and protective covering members attached to the stent frame to prevent contact with the leaflets. The leaflets have a three-part shape with planar regions connected by a concave region. This shape reduces stress and improves function compared to conventional leaflets. The covering members on the stent frame prevent direct contact between the leaflets and frame during expansion, which can degrade the leaflet material.

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A prosthetic heart valve assembly for sealing native valves and reducing regurgitation, along with methods for implanting it. The assembly includes a prosthetic device that can be implanted on the native leaflets of a valve like mitral. The device coaps with the opposing native leaflet during valve operation. It attaches using a suture through the leaflets. The device can be delivered using a catheter or rail to the valve. The assembly also has expandable bodies to anchor the prosthetic valve in place. The expandable bodies secure to the native valve annulus and engage the prosthetic valve surface. This holds the prosthetic valve within the annulus.

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Expandable prosthetic heart valve with features to prevent paravalvular leakage and improve longevity. The valve has an expandable frame, a valve body, and an annular skirt. The skirt surrounds the frame exterior to block flow around the valve. The frame has anchors to secure the valve in place. The valve can be delivered through minimally invasive procedures. The skirt and anchors prevent paravalvular leakage. The skirt with holes allows some regurgitation initially. The anchors atraumatically fixate the valve. The frame design reduces thrombosis. The skirt and frame features enable valve-in-valve replacement.

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A synthetic valve membrane for use in prosthetic heart valves that promotes tissue ingrowth to prevent complications like thrombus formation. The membrane has a porous structure made of a stretched fluoropolymer like ePTFE, with pores filled by an elastomeric material. The membrane can also have a tissue inward growth curtain adhered to the underlying membrane base. The curtain contains pores filled with an absorbable filler material. The membrane is fixed to the valve frame to encourage tissue ingrowth across the frame and membrane interfaces.

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Tissue-engineered heart and vein valves that can be implanted without the need for lifelong anticoagulation therapy. The valves are made by culturing cells in a hydrogel to form an extracellular matrix around a stent. The hydrogel is then everted through the stent and anchored to form commissures and leaflets. The matrix remodels into a functional valve tissue. The engineered matrix provides durability, low pressure drop, and minimal regurgitation.

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Prosthetic heart valves with reduced risk of thrombosis and methods for assembling and implanting them. The valves have hermetic layers preventing tissue ingrowth from the patient's tissue into the valve leaflets. The hermetic layers can be directly formed on the frame or attached to the inner skirt. The leaflets have curved cusps to reduce stasis. This reduces thrombosis in low pressure applications like mitral or tricuspid valves. The valves are delivered collapsed then expand in place.

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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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Self-expanding prosthetic valve replacement system for treating heart valve diseases like mitral regurgitation. The system replaces a diseased native valve without open-heart surgery. It uses an expandable anchoring member with end portions to secure in the native annulus. An expandable support member with the prosthetic valve is contained inside. The device is delivered through a catheter, expanded, and released to replace the native valve. The anchoring members fixate in place while the support member expands. This provides a secure valve implant without suturing or attaching to the native annulus.

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Prosthetic heart valves with synthetic leaflets that are heat treated to improve motion and coaptation. The leaflets are made from synthetic materials like UHMWPE, PTFE, or polyurethane. Heat setting the leaflets at temperatures between 90-170°C for 20-30 seconds biases the leaflets towards either the closed or open position. Folds or creases formed during heat setting further guide leaflet motion. This heat treatment provides a more uniform leaflet shape and motion compared to untreated synthetic leaflets.

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Foldable prosthetic heart valve made from a flexible substrate that can be folded into the final valve shape. The valve has regions defining the leaflets and outer wall when folded. The leaflet regions are arcuate segments extending from the outer to inner periphery, with adjacent leaflets meeting at seams. The wall regions are between the leaflet seams. When folded, the seams form the cylindrical outer wall and the leaflets are the flexible parts extending from the inner to outer periphery.

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An expandable prosthetic mitral valve with a constraining element to control expansion during delivery. The valve has an expandable frame with an atrial flange, ventricular skirt, annular region, and anchor tab. A constraint element applies a hoop force to the frame to limit expansion during delivery. This prevents sudden opening that could move the valve. The valve can be advanced in a crushed state using the hoop force, then expanded in place. The constraint also helps with accurate deployment and anchoring. The valve can have features like echo-sourced tips for visualization during delivery.

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A minimally invasive prosthetic heart valve for replacing dysfunctional atrioventricular valves like the mitral valve. The valve is designed for transcatheter delivery and implantation through small incisions without open-heart surgery. The valve has a valve portion with expandable artificial leaflets, a binding portion that constricts expansion, and a connecting portion to securely attach the valve portion to the binding portion. The binding portion surrounds the natural valve annulus without interruption to prevent regurgitation. The binding portion can have annular or saddle shapes matching the natural annulus. The binding portion expands to pinch the natural valve leaflets and provide tightness. The connecting portion secures the valve portion to the binding portion.

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Modular heart valve prosthesis that can be delivered through smaller catheters compared to traditional valve replacements. The modular design allows separating a first self-expanding valve device with synthetic leaflets from a second balloon-expandable valve device with tissue leaflets. The first device is delivered and expanded first, then the second device is inserted and expanded inside the first device. This allows a smaller initial delivery profile for the first device, followed by expansion of the second device inside. The modular design reduces the crossing profile during delivery compared to a single-piece valve replacement.

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Prosthetic heart valve with improved durability for younger, lower-risk patients. The valve has leaflets with a reinforcing material like sutures or a rigid skeleton attached to the biological tissue leaflets. This reinforcement provides strength to areas of the leaflets with higher stresses like the belly attachment points. It prevents tearing or hole formation compared to all-biological leaflets. The reinforced leaflets can better withstand forces without excessive thickness that would impede collapsibility. The valve also allows variable leaflet thickness to reduce volume while concentrating reinforcement where needed.

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