Advancements in Tissue and Polymer Prosthetic Heart Valves

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 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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Polymer coated prosthetic heart valves with improved integrity and durability. The valves have a frame with valve leaflets attached. The leaflets have a porous support web coated with a polymer to strengthen it. The coating covers the web attachment points to avoid suture holes through the coating. The coating can be applied by methods like dip coating.

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Implantable venous valve device for treating venous insufficiency by replacing damaged valves in veins. The device has a bioprosthetic valve made from a harvested native valve leaflet and contiguous wall segment. This bioprosthetic valve is attached to a support frame that creates a sinus region in the recipient vein. The device can be delivered percutaneously and implanted at the treatment site. The bioprosthetic valve mimics native valve function to restore venous flow direction. The device aims to address shortcomings of current treatments for venous insufficiency like compression stockings and surgical bypasses.

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Packaging for sterile storage of dry prosthetic heart valves that is lighter and less bulky than current liquid-filled packaging. The packaging uses a double sterile barrier to protect the dry tissue implant during sterilization, transit, and storage. The inner barrier is a tray with a lid that suspends and secures the valve. The outer barrier is a secondary container that holds the tray and is sealed for gas sterilization. Then the outer container is sealed with an impermeable barrier to prevent oxidation.

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A replacement mitral valve and valve support for minimally invasive transvascular implantation that can be crimped to a small diameter for delivery through a catheter. The valve has a collapsible stent-like portion with leaflets, covered by a fabric or tissue sleeve. Commissural struts connect the leaflets to prevent collapse. The valve support has similar components but lacks leaflets. The devices have a hollow frusto-conical plug element to improve sealing in the native annulus. The plug is frusto-conical with a larger upper diameter than lower to match the annulus size. The plug attaches to the device and is surrounded by a fabric sleeve. The device also has support elements for attaching the plug fabric. The frusto-conical shape and fabric sleeve help prevent paravalvular leakage.

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A tissue-based replacement heart valve with improved durability and expandability for minimally invasive delivery. The valve has a flexible tubular outer layer with thin walls and a thin inner layer containing the valve leaflets. The outer layer is sewn to the leaflets at the edges and commissures. This allows the thin leaflets to move freely without stress concentrations. The stent can have a foreshortening section that expands longitudinally when radially compressed. This prevents valve stretching or crushing during stent compression. The valve body is attached to the stent outside the foreshortening section. This allows the body to move longitudinally relative to the stent during foreshortening. The valve body can also have a stretchable section that stretches or contracts with the stent. The separate inner and outer layer construction with sewn edges improves durability compared to traditional se

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Heart valve prosthesis for cardiac surgery that aims to improve upon traditional valves by eliminating the need for synthetic materials, reducing thrombus and bacterial attachment, simplifying manufacturing, and improving compliance with the heart. The valve is made entirely of biological tissues, with the valve leaflets, auxiliary structure, and support frame all made of animal pericardium or other biocompatible materials. This eliminates synthetic fabrics and metals that can promote thrombus and bacterial attachment. The valve is also manufactured using a preset suturing pattern to standardize assembly and simplify production.

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A transcatheter heart valve with a sealing component that prevents leaks around the implant. The sealing component is made from tissue with an altered extracellular matrix that contains weakened connections. When blood infiltrates these weakened connections, the tissue swells and expands to fill gaps between the valve and native valve annulus, reducing paravalvular leakage. The tissue with altered extracellular matrix is more compressible in its compressed state for delivery, but expands when exposed to fluid.

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Implantable valve devices for treating cardiac and venous valve disorders using tissue grown in the patient's own body. The valves have cusps made by inserting a device into a body cavity like the abdomen, allowing tissue to grow on it, then removing the device. The isolated granulation tissue forms the cusps. This autologous tissue reduces the risk of rejection compared to synthetic valves. The valves can be customized to match patient anatomy by varying the cusp size and shape. The tissue is manipulated before implantation to optimize performance. The valves are packaged sterilely and delivered percutaneously.

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A percutaneously implantable replacement heart valve that can be delivered through a small catheter for minimally invasive valve replacement. The valve has a collapsible stent and a unique foldable valve leaflet design made from cleaned and pressed bovine pericardium. The leaflets are formed by folding the pericardium instead of cutting and suturing separate leaflet pieces. This reduces tearing risk. The valve is expanded inside the stent to its functional size. The foldable design allows compact delivery through small catheters.

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Prosthetic heart valves that delay valving function immediately after implantation to reduce thrombosis and improve survival. The valves have features like restraining members that temporarily prevent leaflet movement between open and closed positions after implantation. This allows unobstructed blood flow in both directions until the vessel heals. The restraining members are removed later, allowing normal valve function. The delay prevents thrombogenic turbulent flow and trauma that can occur when valves immediately close after implantation.

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Bioprosthetic heart valve with a flexible leaflet design that conforms to the native annulus shape during implantation while preventing migration. The valve has commissural sutures that are initially tightened to a first distance. After implantation, some sutures are removed to loosen the commissures to a second distance. This creates a larger valve circumference that conforms to the annulus while preventing compression and migration. The leaflets coapt at a smaller diameter when the stent is partially expanded.

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