Leak Prevention in Prosthetic Heart Valves
57 patents in this list
Updated:
Paravalvular leak (PVL) affects up to 10% of prosthetic heart valve implants, leading to complications that range from mild hemolysis to severe heart failure. When PVL occurs, blood flows between the prosthetic valve's external surface and the native tissue, creating pathological flow patterns that can necessitate costly reintervention procedures.
The fundamental challenge lies in creating a reliable seal between the prosthetic valve and the irregular, calcified surface of the native annulus while maintaining the delicate balance between radial force, tissue compliance, and long-term durability.
This page brings together solutions from recent research—including expandable sealing members that respond to retrograde flow, containment rings with active tissue coupling, and adaptive cuff designs that conform to irregular surfaces. These and other approaches focus on achieving consistent sealing while accommodating the dynamic nature of cardiac tissue and maintaining deliverability through minimally invasive routes.
1. Replacement Cardiac Valve System with Containment Ring and Resilient Scaffold for Migration Restriction
VALCARE, INC., 2023
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.
2. Expandable Prosthetic Heart Valve with Annular Frame and Outflow Sealing Member Featuring Mesh Layer with Pile Yarns
EDWARDS LIFESCIENCES CORPORATION, 2023
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.
3. Prosthetic Heart Valve Device with Flexible Clasp Mechanism and Self-Expanding Coaptation Element
EDWARDS LIFESCIENCES CORP, 2023
Prosthetic device for sealing a native heart valve and reducing regurgitation while preserving native valve function. The device has clasps that attach to leaflets and close during systole to prevent regurgitation. The clasps have flexible ends that move apart during diastole as leaflets open. This allows leaflet motion while still sealing. The clasps flex to move together during systole. The clasps can also bend to adapt to leaflet shape. A coaptation element in the valve orifice further helps seal. The clasps and coaptation element can self-expand after delivery. The device can be delivered through a catheter.
4. Collapsible Heart Valve with Misaligned Grid Structure and Adaptive Seals
SHANGHAI NEWMED MEDICAL CO LTD, 2023
Artificial heart valve design to reduce paravalvular leakage and compressible size. The valve has a collapsible support structure with rows of misaligned grid structures. Seals are placed over portions of the grids. When the valve expands, the seals cover the grids to prevent regurgitation. When the valve collapses, the seals shrink. This reduces paravalvular leakage without adding bulk.
5. Transcatheter Valve Prosthesis with Dual-Skirt Anti-Paravalvular Leakage Mechanism
Medtronic, Inc., 2023
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.
6. Prosthetic Heart Valve with Radially Extending Anchors and Variable Conformity Features
EDWARDS LIFESCIENCES CORP, 2023
Prosthetic heart valve design to improve sealing and anchoring at the implantation site. The valve has features to conform better to non-circular native valves and reduce paravalvular leakage. The valve has anchors that extend radially outward from the leaflets to engage the native valve annulus. It also has anchors that abut the leaflets to prevent prolapse. This allows secure fixation of the valve without requiring circular symmetry. The valve can also have features like distal anchors, expandable frames, adjustable outer diameters, inflatable seals, and frameless seals for better anchoring and sealing.
7. Transcatheter Mitral Valve Replacement System with Prosthetic Half-Valve and Dual Guide Fixation Members
SHUCIA MEDICAL INC, 2023
Transcatheter mitral valve replacement system with a prosthetic half-valve that attaches directly to the native mitral valve annulus to prevent displacement and regurgitation. The prosthetic half-valve has a stent with an atrial portion to anchor the valve and a ventricular portion to displace the diseased leaflet. Dual guide and fixation (DGF) members with compressible legs secure the stent to the annulus. The prosthetic leaflets attach to the stent and skirt. The half-valve design allows for compact delivery, improved anchoring, and reduced paravalvular leakage compared to full-size prostheses.
8. Artificial Heart Valve with Collapsible Misaligned Grid Support and Radially Expanding Seals
SHANGHAI NEWMED MEDICAL CO LTD, 2022
An artificial heart valve design to reduce paravalvular leakage while compressing smaller for delivery through narrow vessels. The valve has a collapsible support structure with misaligned grid rows, an inner skirt, artificial leaflets, and external seals. The seals cover grid sections and expand radially when blood regurgitates into pockets formed by the misaligned grids. This enhances seal against native tissue and prevents paravalvular leakage.
9. Endovascular Aortic Valve Replacement Device with Expandable Frame and Detachable Prosthetic Components
Aortic Innovations, LLC, 2022
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.
10. Heart Valve Prosthesis with Multi-Layer Sealing Mechanism and Functionally Segmented Frame
SHANGHAI TRULIVE MEDTECH CO LTD, 2022
A heart valve prosthesis with a sealing mechanism to prevent paravalvular leakage in minimally invasive valve replacements. The prosthesis has a frame to support the artificial valve leaflets and a sealing mechanism covering the frame surface. The sealing mechanism has layers, like an inner hydrophilic layer and an outer non-permeable layer, that expand when wet to seal against tissue. This helps fill gaps and prevent leakage around the prosthesis. The double-layer frame distributes functions like leaflet support and sealing to different parts.
11. Stent Assembly with Reversible Cuff Orientation Using Shape Memory Elements
St. Jude Medical, Cardiology Division, Inc., 2022
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.
12. Prosthetic Mitral Valve with Angled Outflow Orifice and Offset Centerline
Neovasc Tiara Inc., 2022
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.
13. Tricuspid Valve Prosthesis with Ventricular Septum Anchoring and Adaptive Sealing Mechanism
THE FIRST AFFILIATED HOSPITAL OF THE SECOND MILITARY MEDICAL UNIV, THE FIRST AFFILIATED HOSPITAL OF THE SECOND MILITARY MEDICAL UNIVERSITY, 2022
Tricuspid valve prosthesis that is fixed on the ventricular septum to prevent paravalvular leakage. The prosthesis has a stent, artificial valve leaflets, a sealing device, and an anchoring member. The sealing device is unique in design to prevent paravalvular leakage. It has a sealing rod and an elastic adaptation layer. When the atrial wall squeezes the sealing device, the sealing rod folds toward the bottom of the native valve annulus, preventing gaps and folds in the atrium segment. The elastic adaptation layer compresses and expands with the native valve annulus, fitting and sealing it. This avoids blood reflux from folds and gaps.
14. Artificial Heart Valve with Hydrophilic Inflow Sealing Membrane and Coiled Leaflet Anchor
SHANGHAI NEWMED MEDICAL CO LTD, 2022
An artificial heart valve designed to reduce paravalvular leakage and minimize the risk of displacement during implantation compared to conventional valves. The valve has features like an inflow sealing membrane, an outflow sealing membrane, a leaflet, and a leaflet anchor. The inflow sealing membrane is made of a hydrophilic material that expands when contacting blood to prevent leakage. The outflow sealing membrane covers the inflow sealing membrane to further reduce leakage. The leaflet anchor is a coiled structure that wraps around the chordae tendineae outside the native valve to secure the valve in place.
15. Artificial Heart Valve with Dual Sealing Membranes and External Anchor for Enhanced Stability
SHANGHAI NEWMED MEDICAL CO LTD, 2022
An artificial heart valve with features to improve stability and reduce paravalvular leakage compared to standard heart valve replacements. The valve has a unique design with a valve support, sealing membranes, a leaflet, and an anchor. The valve support has an inflow section and outflow section. A first sealing membrane covers the outside of the inflow section. A second sealing membrane is on the inside and folds outward. The folded second membrane covers part of the first membrane to prevent leakage. The leaflet is inside the support. An anchor outside the chordae tendineae helps stabilize the valve during heart contractions.
16. Artificial Heart Valve Prosthesis with Rotational Sealing Frame and Fulcrum-Based Leak Prevention Mechanism
NINGBO JIANSHI TECH CO LTD, NINGBO JIANSHI TECHNOLOGY CO LTD, 2022
An artificial heart valve prosthesis with a sealing device to prevent paravalvular leakage when the heart beats. The valve prosthesis has a sealing frame connected to the support structure. The sealing frame provides a fulcrum point. When the heart contracts, the sealing frame rotates around the fulcrum, with one curved segment moving inward and the other outward. This action drives the valve leaflet to fit against the native valve annulus and atrial wall. It also lifts the sealing member to fit against the native valve annulus. This ensures tight sealing during contraction and expansion cycles.
17. Collapsible Prosthetic Heart Valves with Expandable Sealing Members Featuring Directional Openings
St. Jude Medical, Cardiology Division, Inc., 2022
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.
18. Prosthetic Heart Valve with Inner Stent Frame and Concave Waist Outer Anchor Assembly with Integrated Gasket
Cephea Valve Technologies, Inc., 2022
A prosthetic heart valve with a sealing feature to prevent paravalvular leakage (PVL) around the valve annulus while minimizing delivery profile. The valve has an inner stent frame, an outer anchor assembly, a gasket, and leaflets. The gasket surrounds the outer anchor waist portion to seal against the annulus. In the collapsed state, the gasket doesn't extend beyond the anchors. This allows a smaller delivery profile. The outer anchor has a concave waist that aligns with a convex skirt protrusion. This geometry helps prevent PVL. The inner stent, outer anchor, gasket, and leaflets expand to implant the valve.
19. Heart Valve with Grid-Like Frame and Blocked Sections for Reduced Paravalvular Leakage
HANGZHOU XINSMOOTH MEDICAL EQUIPMENT LIMITED CO, HANGZHOU XINSMOOTH MEDICAL EQUIPMENT LTD CO, 2022
A percutaneously implanted heart valve design that reduces paravalvular leakage during transcatheter valve replacement. The valve has a unique holder structure that helps prevent blood regurgitation around the edges. The valve holder has a grid-like frame with blocked sections. The valve leaflets are mounted inside the frame. The skirt around the valve attaches to both the leaflets and the bottom of the frame. During implantation, the compressed valve is expanded in place to replace the native valve. The blocked sections of the frame prevent blood from flowing between the native annulus and the valve holder, reducing paravalvular leakage.
20. Artificial Heart Valve Connection Structure with Sutured Membranes, Zigzag Skirts, and Sealing Strips for Leak Prevention
COKEVA LIFE SCIENCE LIMITED CO, COKEVA NANTONG LIFE SCIENCE LTD CO, 2022
Artificial heart valve connection structure to prevent paravalvular leakage in transcatheter aortic valve replacement (TAVR) procedures. The structure connects the artificial heart valve support and the valve leaflets in a way that prevents paravalvular leakage. It uses features like sutured membranes, zigzag skirts, and sealing strips to securely attach the valve components. This reduces the risk of leaks between the valve and the native heart tissue, which can cause complications. The sutured membranes cover the inflow end of the support, with a matching zigzag skirt. A sealing strip attaches to the leaflet and has a clip to fold over the support. This provides a secure and leak-free connection between the valve components during TAVR implantation.
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Preventing paravalvular leakage is essential for improving prosthetic heart valve performance and patient outcomes. Recent innovations in sealing mechanisms, material design, and valve structures are minimizing leakage risks and reducing the need for re-intervention. These advancements ensure that prosthetic valves deliver long-lasting, efficient, and reliable results, contributing to better cardiovascular care worldwide.