Hybrid Prosthetic Heart Valves: Innovations in Design and Technology

Improving features of implantable medical devices, such as prosthetic heart valves, for implantation, function, and explant. The valves have skirts with inner thromboresistant sections and outer tissue ingrowth-allowing sections. The inner section prevents thrombosis, while the outer section promotes tissue attachment. The skirt is also bioresorbable and can be separated during implant removal. The valves can also have bioresorbable couplers between the skirt and leaflets. This allows tissue growth while the valve is implanted,and then the couplers dissolve for easy explant. The skirt can also be porous for tissue ingrowth.

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Self-expanding replacement mitral valve that can be delivered minimally invasively and has improved flexibility for implantation in the complex mitral valve anatomy. The valve has a separate ventricular anchor, central portion, and atrial anchor that expand radially. The atrial anchor has an annular frame with apertures aligned with central portion apertures. Couplers extend through the aligned apertures and are plastically deformed to secure the central portion and frame. This allows separate expansion and flexibility of the ventricular and atrial anchors while maintaining valve integrity. The valve also has struts connecting the central portion to the leaflets.

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A simplified hybrid prosthetic heart valve design for easier assembly and reduced labor hours, that facilitates valve-in-valve deployment and reduces manufacturing complexity. The valve has a expandable frame at the inflow end that can be compressed for delivery. The expandable frame can plastically expand when subjected to sufficient force, allowing post-implant expansion. This avoids the need for an overall expandable frame. The inflow stent provides anchoring while allowing valve-in-valve. The outflow stent is compressible to reduce size during delivery.

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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 design with multiple leaflets that grow with the patient's heart and avoids commissure failure like current valves. The valve has multiple aligned tubular members that are sutured together longitudinally and horizontally to form the leaflets. This prevents the inner tubes from collapsing like in prior designs. The commissures are defined by fixed attachment of the exterior surfaces of adjacent tubes along the longitudinal axis. This allows the valve to grow as the patient's heart expands, unlike fixed-tube designs. The valve can be made by growing collagenous matrix tubes in vitro from cells and then decellularizing them for use as allografts.

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A holder for a hybrid surgical prosthetic heart valve that enables quick release and deployment of the valve during surgery, reducing the time the heart is stopped. The holder has sutures that constrict an expandable anchoring stent on the valve inflow end. Severing the sutures allows the stent to expand to its natural size and detach the holder.

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Composite skirt for a prosthetic heart valve with optimized regions to reduce regurgitation and improve function. The skirt has separate sections for the inflow, transition, and outflow segments of the stent. The inflow section has elasticity for adaptation. The transition and outflow sections have skirts with lower permeability materials to reduce regurgitation. When the permeability of the transition skirt is higher than the outflow skirt, regurgitation is further reduced. This tailored skirt design allows matching skirt parameters to the stent regions for better primary tissue integration and reduced regurgitation.

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A replacement heart valve that can be compacted for delivery and then expanded in place during minimally invasive procedures. The valve has an expandable frame with anchors to engage the native valve annulus. The valve body is attached to the frame and has larger diameter at the downstream end compared to the upstream end. This configuration allows the valve to expand radially while compressing longitudinally during delivery. The anchor tips positioning and differential frame diameters enable controlled placement and secure fixation once expanded.

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Heart valve replacement prosthesis with improved alignment properties for minimally invasive implantation. The prosthesis has a stent with annulus and commissure alignment features. The annulus alignment means engage the native valve annulus and the commissure alignment means engage the native valve commissures. This provides better alignment and seating of the prosthesis without interfering with the heart structure. The alignment features also prevent blockage of coronary artery ostia. The prosthesis ratio of annulus to commissure distance to annulus diameter is 1.01-1.14, mimicking the native valve. The cell distribution in the inflow and outflow ends further mimics the native valve. The alignment features, cell distribution, and prosthesis dimensions improve prosthesis alignment, durability, and reduce long-term side effects compared to prior art prostheses.

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A prosthetic tricuspid valve that biodynamically fixes to the native valve without direct attachment to preserve native motion. The prosthetic valve has an asymmetric central passageway support structure that grasps and stabilizes the native leaflets. Leaflets inside the passageway control blood flow. Cover segments enclose arm sections to reduce leakage. The asymmetry allows motion with pressure differentials. This allows the valve to move with the native annulus without direct attachment.

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Heart valve assembly with a jacket to enhance biocompatibility and reduce thrombus formation. The heart valve has a frame, leaflets, and a jacket that covers gaps and interfaces between the frame and leaflets. The jacket helps mask manufacturing imperfections and customize the valve based on patient needs. The jacket material can be porous synthetic polymer membrane with an elastomer filling the pores. The jacket can also have a composite leaflet with a porous synthetic polymer membrane and elastomer filling the pores.

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Hybrid surgical prosthetic heart valves with sealing solutions to reduce paravalvular leakage during implantation. The hybrid valve has a non-expandable valve member and an expandable stent. Sealing structures around the stent prevent leakage between the stent and implant site. These include flaps, covers, pleated skirts, bands, patches, glue, and expandable foam. The expandable stent allows faster implantation compared to suturing. The sealing structures mitigate leakage around the stent when expanded.

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A percutaneous mitral valve replacement device for treating mitral valve stenosis or insufficiency. The valve has a collapsible frame with a wire stent and wire mesh. The wire stent provides radial strength for the valve lumen and orifice, while the wire mesh adds flexibility for conforming to the mitral annulus. The frame captures and immobilizes the native mitral leaflets during deployment. This provides tactile feedback and stabilization at the ventricular level. The frame design allows optimal sealing and apposition at the annulus and atrial floor. The valve can be delivered retrograde or antegrade through a catheter for minimally invasive implantation.

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Heart valve prosthesis for minimally invasive implantation at larger sizes like for mitral valve replacement. The prosthesis has a deformable fixation support member that extends radially outward from the inner contact surface. It attaches to the valve at the inflow end. This allows the prosthesis to be inserted through a small incision and expanded inside the heart. The deformability allows the fixation member to compress for insertion and expand to secure the prosthesis in place.

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