Innovative Paravalvular Leak Prevention in Prosthetic Heart Valves

A system and method to prevent paravalvular leak (PVL) in replacement cardiac valves. The system uses a containment ring that actively couples to the native valve annulus to prevent axial migration. Inside the ring, a resilient valve scaffold engages both the ring and native valve. This prevents scaffold translation. The ring has anchors that continuously bias the annulus tissue towards the ring. The scaffold transitions from insertion to operative configuration within the ring. This encloses the scaffold vertex inside the ring, preventing axial movement. The ring and scaffold prevent PVL by restricting valve migration.

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An expandable prosthetic heart valve with improved sealing to reduce paravalvular leakage. The valve has an annular frame that compresses for delivery and expands when implanted. A sealing member surrounds part of the outer frame surface near the inflow end. This member bulges outward when the valve expands, sealing against the tissue. The sealing member length matches the frame's compressed length. This allows the frame to expand without damaging the sealing member. The sealing member can have a mesh layer with pile yarns extending outward. The inner mesh surface contacts the frame, while the outer pile yarns bulge out.

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Transcatheter valve prosthesis with an anti-paravalvular leakage component to prevent blood regurgitation around the valve when deployed in a native heart valve. The anti-PVL component has an inner skirt on the valve stent and an outer wrap forming a cavity accessible via a one-way valve. Blood can flow into the cavity but not out. When the valve expands, the outer wrap expands, too, filling gaps and sealing against the native valve. The cavity fills with blood, clots, and seals permanently.

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Endovascular aortic valve replacement device for treating aortic aneurysms, valve disease, and dissection in a way that allows for future valve re-interventions and coronary re-interventions. The device has a unique prosthetic component design with an expandable frame that tapers inwardly at the proximal end and outwardly at the distal end. This allows the device to engage the aortic annulus while avoiding coronary compression. The device also has a covered stent that can be advanced through a conduit in the first prosthetic component to access a coronary artery. This allows separate access to the coronaries without compressing the native valve. The device can also have a detachable first prosthetic component that is introduced first, followed by a second prosthetic component that expands to seal the aorta.

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A replacement stent assembly for prosthetic heart valves that reduces paravalvular leakage. The stent has an attached cuff that can invert between two orientations - inside the stent lumen and over the stent abluminal surface - using shape memory or elastic members. This allows the cuff to seal against the stent and tissue when deployed to reduce leaks, but retract inside the stent for delivery to maintain a low profile.

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Prosthetic mitral valve with improved design to reduce regurgitation and improve blood flow compared to conventional mitral valve replacements. The valve has features like angled outflow orifice, offset centerline, and flange directing flow towards the posterior wall to enhance flow dynamics. It also has a frame expandable into the native valve for anchoring. The valve is delivered minimally invasively into the native valve. The unique design aims to improve regurgitation reduction and blood flow compared to conventional mitral valves.

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Collapsible prosthetic heart valves with sealing mechanisms to mitigate paravalvular leakage. The valves have expandable sealing members attached to the cuff surrounding the stent body. These members have openings facing the blood flow direction. When blood flows retrograde, it pushes into the sealing members causing them to billow outwardly against the tissue, sealing against leakage. The sealing members can be rectangular, triangular, trapezoidal, or semicircular.

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Minimally invasive replacement mitral valve that can be delivered through small incisions and access routes, like the apex of the heart or transseptally through the left atrium. The valve has a self-expanding anchor with separate ventricular and atrial portions that flare out radially when expanded. The atrial portion is not integrated with the central portion but is secured to it. This allows flexibility in the atrial portion. The central portion has overlapping apertures that align with the atrial portion apertures. Couplers extend through these aligned apertures and are plastically deformed to secure the central portion and atrial portion together. The valve also has struts connecting the leaflets to the anchor. The separate expandable ventricular and atrial portions with overlapping apertures and coupler deformation allows flexibility in the atrial portion for better adaptation to the mitral

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A stented prosthetic heart valve with a wrap to prevent paravalvular leakage and delivery devices to selectively deploy the wrap. The wrap is made of a flexible material that can be stretched over the stent frame of the valve and anchored at various points to cover and seal any gaps between the prosthetic valve and the surrounding native tissue. The wrap can be selectively deployed after the valve is implanted using a delivery catheter with retractable sheaths. The sheaths cover the wrap during delivery and can be retracted to expose the wrap for deployment. This allows the wrap to be precisely positioned and anchored where needed to seal paravalvular gaps. The wrap can also be repositioned or retrieved if necessary.

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Catheter-based prosthetic heart valves with sealing members to prevent regurgitation, and delivery systems for implanting them. The valves have a collapsible frame, expandable valve, and a skirt assembly. The skirt has upper and lower skirts to connect the valve to the frame, and an outer sealing skirt that protrudes through the frame cells when expanded. This seals against the native tissue. The delivery systems have sheaths with inner liners made by expanding a polymer tube against a metal sleeve. This reduces friction and kinking during insertion. The valve can be advanced with precise controlled motion for deployment.

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Heart valve replacement device with a sealing member to prevent paravalvular leakage around the implanted valve. The sealing member is separate from the valve and has protrusions that extend radially outward when attached to the collapsible stent. These protrusions contact the native annulus to create a sealed interface and prevent blood leakage. The protrusions can be formed by folding or pinching the sealing member material. This allows the stent to self-expand and reposition without compromising the seal. The sealing member can be positioned internally or externally on the stent.

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Transcatheter heart valve with a sealing component to prevent paravalvular leakage around the prosthetic valve. The component is a self-expanding ring with segments that curve radially away from the valve stent. The segments attach to the stent surface at spaced points. When deployed, the ring expands and fills gaps between the valve and native valve annulus to seal against leakage. The segments have varying flexibility to conform to the native anatomy.

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Prosthetic heart valve for implantation at the mitral valve that reduces migration and improves fixation compared to existing mitral valve replacements. The valve has a radially expandable frame with projections that penetrate the native mitral valve leaflets to secure the prosthetic valve in place. This provides better anchoring and migration resistance compared to valves that just expand inside the annulus. The projections engage the leaflets during implantation to fix the valve in position. The valve can be delivered transapically or transatrial and expands inside the leaflets.

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Heart valve replacement system with an expandable and collapsible stent, a heart valve mounted inside the stent, and a sealing member around the stent inflow end. The sealing member expands to seal against the native annulus and prevent paravalvular leakage. It can collapse for delivery through a catheter. The stent connects to the sealing member at points. This allows the sealing member to extend around the stent and fill gaps between the stent and annulus for a better seal.

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Collapsible prosthetic heart valve with a sealing member that can move to reduce paravalvular leakage. The valve has an expandable stent, leaflets, and a cuff. The sealing member extends from the cuff to a free edge. It can be moved from an extended position proximal to the stent to an inverted position distal to the stent after initial deployment. This inverted position allows the sealing member to engage the native valve annulus and reduce gaps between the valve and native valve, reducing paravalvular leakage.

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Prosthetic heart valve design to reduce paravalvular leakage by adding a tissue liner inside the outer layer of the valve support structure. This liner prevents blood flow between the valve leaflets and the support structure. The liner can extend through gaps in the support structure or be attached to the inner or outer surface of the middle layer. The valve also has a tissue skirt attached to the inner or outer surface of the middle layer to further reduce leakage.

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Collapsible prosthetic heart valve with reduced paravalvular leakage by optimizing the fit between the valve and the native annulus. The valve has a unique cuff design with features like concave struts, notches, and gathered edges. These features allow the cuff to better fill gaps between the valve and native annulus, reducing paravalvular leakage. The concave struts on the stent have curved shapes that allow the cuff to billow outward and fill gaps. The notches and gathered edges on the cuff can close up to match the irregular native annulus better.

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Transcatheter heart valve with a skirt component to prevent paravalvular leakage. The skirt, made of flexible material, encircles the outer surface of the valve stent. It has a fixed edge attached to the stent and a free edge that can expand radially. This expansion allows the skirt to fill gaps between the valve and native tissue, sealing against leakage. An expandable control ring on the free edge extends the skirt outward against the native valve. The skirt catches retrograde blood flow to prevent regurgitation.

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