Major Prosthetic Heart Valve Innovations to Prevent Thrombosis

Implantable prosthetic heart valve design with features to improve explantability and reduce complications. The valve has a skirt around the valve body that allows tissue ingrowth. This skirt is porous to promote tissue ingrowth. An inner thromboresistant skirt contacts the heart tissue to prevent thrombus formation. The prosthetic leaflets are attached to the valve body with bioresorbable couplers. This allows the skirt to separate and detach from the leaflets when the couplers dissolve, making explant easier. The bioresorbable couplers also allow the skirt to separate from the leaflets after implantation if needed.

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Prosthetic heart valves with reduced risk of thrombosis. The valves have hermetic layers on the skirts and a unique leaflet design to prevent tissue ingrowth and abnormal leaflet motion. The inner skirt prevents cells from growing onto the leaflets. The leaflets have curved cusp edges and parallel tabs to reduce stasis. This avoids tissue ingrowth onto the leaflets and reduces thrombosis from abnormal leaflet motion.

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Prosthetic heart valve design to mitigate blood stasis and reduce fluttering of the leaflets. The valve has openings in the inner wall that redirect blood flow away from the main passage. This reduces the volumetric flow rate below a threshold to prevent fluttering. The redirected flow has a component normal to the main flow to prevent stagnation. The openings are positioned to flush valve surfaces and promote laminar flow. The flow fields are shaped to have low Reynolds numbers to prevent turbulence. This reduces shear stress below thresholds for platelet activation and hemolysis.

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Prosthetic heart valve design to improve implantation and sealing while reducing complications like leakage, migration, impingement, and conduction disruption. The valve has a collapsible stent body with expandable annulus region. The cuff surrounds the annulus and has features like pleats, biasing elements, and movable portions to better conform to irregular native tissue during expansion. The cuff can also have pockets to expand against tissue. These design elements aim to provide adequate sealing without excessive radial force on the native valve annulus.

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Heart valve replacement prosthesis for minimally invasive treatment of aortic valve stenosis and insufficiency. The prosthesis has a collapsible expandable stent and a valve component. The stent has alignment features like feelers to engage with native cusps and commissure alignment means. The valve component has specific cell distribution and aspect ratios in the inflow and outflow regions. This design aims to mimic native valve anatomy and alignment for better implantation and long-term performance compared to prior prostheses.

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Valved conduit for replacing pulmonary valves that reduces thrombus formation compared to traditional valved conduits. The valve structure is formed by non-mechanically adhering flexible synthetic leaflets to the exterior of the conduit. The leaflets are arranged inside the conduit lumen to open and close like a valve without mechanical attachment. This eliminates potential turbulence, stagnant blood pockets, and suture holes that can promote thrombus formation. The valved conduit can be implanted to replace a native pulmonary valve without pre-clotting or reconstruction.

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A heart valve prosthesis that reduces the risk of paravalvular leakage by promoting thrombus formation on the exterior of the prosthesis. The prosthesis has a terminating material on the outer surface of the main body that is designed to induce thrombus formation when it comes into contact with blood. This material can be fibrous, spongy, or liquid-permeable. The thrombus formed seals off any potential leaks around the prosthesis. The terminating material can be made from biocompatible polymers, biopolymers, or cationic polymers. It can be secured to the main body or integrated into the fibers themselves. The material can be configured to deform and crimp when hydrated to increase volume. The goal is to use the patient's own blood coagulation system to prevent leakage from the prosthetic heart valve.

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Mechanically advanced prosthetic heart valve that is more durable and thromboresistant than current valves. The valve is designed to mimic the native aortic valve and can be made from biocompatible polymers like polyurethane. The valve has leaflets with embedded oligofluorinated additives that give the leaflet surface nonstick properties. This reduces blood clot formation and prevents valve obstruction. The additive-modified polymer leaflets are created by coating a base polymer leaflet assembly with a mixture of the base polymer and the oligofluorinated additive. Dip-coating the leaflets in polycarbonate urethane with an oligofluorinated additive in tetrahydrofuran is one example method.

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Diagnosing and monitoring bioprosthetic valve degeneration, particularly calcification, to improve durability of artificial heart valves. The method involves measuring soluble endothelial protein C receptor (sEPCR) levels in biological samples from patients. Low sEPCR indicates a risk of valve degeneration and calcification. Coating the valves with EPCR can protect against degeneration. Anticoagulation can mitigate procoagulant state caused by valve degeneration.

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Prosthetic heart valves with coverings to reduce tissue damage and improve patient outcomes. The valves have a cushioned outer covering with a plush surface layer and a backing layer. The plush layer extends beyond the valve struts to prevent contact with native heart tissue. This reduces friction and abrasion when the valve expands and contracts. The covering also has inflow and outflow protective portions that fold over the valve ends to cushion surrounding anatomy and prevent tissue from contacting the struts.

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Catheter-based system for replacing heart valves in a minimally invasive procedure that allows treating endocarditis while replacing a valve. The system has a stent with a replacement heart valve attached, and chambers in the stent that can be filled with antimicrobial substances. The chambers release the substances into the bloodstream around the valve to treat endocarditis. The chambers can also have fluidic connections to the stent retention areas to directly treat the valve tissue. The chambers can be filled before, during, or after implantation. This allows localized antimicrobial treatment of the valve and surrounding tissue without systemic medication.

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Inhibiting stenosis, obstruction, or calcification of heart valves and stents by coating them with a composition containing therapeutic agents to prevent tissue overgrowth and calcification after implantation. The coating is applied to the stent, valve leaflets, or graft materials before implantation. The coated prostheses are then positioned in the heart to contact the native valves. The coating composition can include anti-proliferative drugs, calcification inhibitors, and anti-inflammatory agents to reduce tissue proliferation, calcification, and inflammation around the prostheses.

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Reducing stenosis, obstruction, and calcification of heart valves and prosthetic valves after implantation by coating the stent portion of the valve prosthesis with a composition containing therapeutic agents. The coated valve prosthesis is then positioned in the heart with the stent in contact with the valve tissue. The coating inhibits cell proliferation, inflammation, and calcification around the stent to prevent valve narrowing or obstruction.

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Prosthetic heart valve assembly with sealing members to prevent paravalvular leakage around the edges of the implanted valve. The sealing members are mounted on the valve and positioned to engage the commissure points of the native valve leaflets. This ensures sealing at the locations where gaps can form between the valve frame and annulus wall. The sealing members are precisely oriented on the valve so they align with the commissural points when the valve is implanted. This reduces leakage through gaps that can form at those points. The valve can have a waisted middle section where the sealing members are located to avoid increasing valve diameter.

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A catheter-based system for percutaneous replacement of pulmonary valves in a less invasive and repeatable procedure compared to open-heart surgery. The system uses a catheter to deliver a valve device with an expandable support structure and a barrier material that prevents blood flow around the valve. The device is expanded inside the existing pulmonary valve conduit to replace the valve. The barrier contacts the conduit wall to seal against regurgitation. This allows replacing the pulmonary valve without disturbing the conduit or surrounding tissue.

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