Leaflet Design for Prosthetic Heart Valves
91 patents in this list
Updated:
Prosthetic heart valve leaflets experience complex mechanical stresses during each cardiac cycle, with peak pressures reaching 120 mmHg during systole and shear forces that can accelerate material fatigue. Current synthetic and biological valve designs show durability limitations, with calcification and mechanical failure occurring in 10-15 years for many patients.
The fundamental challenge lies in creating leaflet structures that can withstand millions of cycles while maintaining natural hemodynamics and preventing thrombosis formation.
This page brings together solutions from recent research—including composite materials with embedded electrospun fibers, asymmetrical leaflet configurations that reduce wear, biomimetic designs that replicate natural valve mechanics, and novel attachment mechanisms that minimize stress concentrations. These and other approaches aim to extend valve longevity while preserving physiological blood flow patterns.
1. Transcatheter Heart Valve Prosthesis with Chevron-Patterned Leaflet Edges and Integrated Valve Cylinder
MEDTRONIC VASCULAR INC, 2024
A transcatheter heart valve prosthesis with reduced stress and pinwheeling compared to conventional designs. The prosthesis has a one-piece molded valve with leaflets that have free edges in a chevron down pattern. This shape reduces pinwheeling and stress on the valve during expansion and contraction. The valve also has the valve cylinder directly attached to the stent inflow portion proximal to the skirt to further reduce prosthetic valve profile.
2. Prosthetic Heart Valve with Non-Uniform Leaflets Incorporating Movable and Stiffer Sections on Expandable Frame
EDWARDS LIFESCIENCES CORP, 2024
Prosthetic heart valve with non-uniform leaflets that have movable sections and stiffer sections. The valve has a frame that expands and contracts. The leaflets are attached to the frame and have sections that move during valve opening/closing, and stiffer sections. The movable sections allow flexible leaflet motion, while the stiffer sections provide support and prevent excessive leaflet deformation. This reduces stress concentrations and leaflet tears compared to uniform leaflets. The non-uniform leaflets are formed as single continuous pieces. The valve assembly method involves attaching the stiffer sections to the frame while the movable sections are left flexible.
3. Polymer Composite Heart Valve Leaflets with Polyurethane-Coated Polyolefin or Polysiloxane Substrate
VENUS MEDTECH HANGZHOU INC, VENUS MEDTECH INC, 2024
Artificial heart valve leaflets made of polymer materials that have improved tear resistance compared to conventional polymer leaflets. The leaflets are made by coating a polyurethane layer onto a substrate of polyolefin or polysiloxane. The coating process involves dissolving the polyurethane in a solvent like N,N-dimethylacetamide and spreading it onto the substrate. This provides a composite leaflet with a hard segment (urethane) layer on a soft segment (polyolefin or polysiloxane) substrate. The composite structure improves tear resistance of the polymer leaflets. The coated leaflets also have better biocompatibility and adhesion to platelets compared to uncoated polymer leaflets.
4. Collapsible Prosthetic Heart Valve with Non-Uniform Tissue Thickness and Integrated Collagen-Producing Cells
St. Jude Medical, Cardiology Division, Inc., 2024
Collapsible prosthetic heart valves with optimized tissue thickness for better delivery and durability. The valves have leaflets made from tissue with non-uniform thickness. The thickness is greatest at the sewing edge and gradually decreases toward the free edge. This allows the valve to be compressed for delivery and then expand to full size once implanted. The thinner edges reduce the collapsible size. The thickness variation also improves durability by reducing stress concentrations. Collagen-producing cells like smooth muscle or stem cells can be incorporated in the tissue to further enhance durability.
5. Transcatheter Prosthetic Heart Valve with Leaflet-Encapsulating Skirt for Compression Protection
MEDTRONIC INC, 2024
Transcatheter prosthetic heart valves that can be compressed for delivery via a catheter without damaging the leaflets. The valves have a skirt that fully encapsulates the leaflets both when compressed and expanded. This prevents localized forces from deforming the leaflets during compression. The skirt extends beyond the leaflet edges in the compressed state to protect them. The skirt also extends past the coaptation area in the expanded state. This configuration allows consistent loading of the valve into a compact catheter shape without risking leaflet damage.
6. Prosthetic Heart Valve with Resilient Protrusion-Assisted Leaflet Actuation
FOLDAX INC, 2024
Prosthetic heart valve with a support structure that actively assists in opening and closing the valve leaflets. The support structure has resilient protrusions coupled to the leaflets and a base. When the transvalvular pressure becomes less negative, the protrusions begin to move from a closed position to an open position, aiding in valve opening. This provides active leaflet assistance compared to passive support structures. The resilient protrusions help the leaflets open and close without needing high leaflet stiffness.
7. Artificial Heart Valve with Leaflet Flaps and Hinge Sheets for Stress Distribution
SHANGHAI MICROPORT CARDIOFLOW MEDTECH CO., LTD., 2024
Artificial heart valve prosthesis that improves durability by distributing stress more evenly around the commissures connecting the valve leaflets to the stent. The valve has leaflets with flaps that extend beyond the commissures and are sutured at both the commissure and stent windows. This spreads forces across the joint instead of concentrating them at the commissure. It also uses hinge sheets between the commissures and flaps to reduce friction.
8. Polymer Heart Valve with Curved Leaflets and Thinned Regions for Stress Dispersion
SUZHOU XINLING MAIDE MEDICAL TECH CO LTD, SUZHOU XINLING MAIDE MEDICAL TECHNOLOGY CO LTD, 2023
Artificial polymer heart valve design with improved fatigue resistance and longer service life compared to conventional valves. The valve has a hollow frame with peaks at one end and multiple leaflets connecting adjacent peaks. The leaflets have a curved shape with at least one thinned region along the curve. The thinned regions increase stress dispersion and reduce peak stresses compared to uniform thickness leaflets. This improves fatigue resistance and extends valve life. The thinned regions also allow earlier leaflet opening for better overall valve performance.
9. Prosthetic Tricuspid Heart Valve with Biomechanical Leaflet Securing and Asymmetric Leaflet Design
Incube8 Medical Technologies Limited Liability Company, INQB8 MEDICAL TECHNOLOGIES LLC, Incubeé 8 Medical Technologies Limited Liability Company, 2023
A prosthetic heart valve designed specifically for the tricuspid valve to address the unique challenges of treating tricuspid regurgitation. The valve is biomechanically secured to the native tricuspid valve leaflets instead of directly attaching to the annulus or chords. This allows the valve to pivot within the native valve annulus in response to pressure changes. The valve has asymmetric leaflets, expanded armsets, and covers to reduce leakage. The expanded armsets have asymmetric lengths to match the native valve leaflets. The covers surround the arms and contact the native valve leaflets. The valve maintains axial stability within the native annulus without attaching to it.
10. Collagen-Based Heart Valve with Integrated Leaflets and Body Molded from Single Sheet
ANTERIS TECH CORP, ANTERIS TECHNOLOGIES CORP, 2023
Replacement heart valves made from a single molded sheet of collagen-based biomaterial that integrates the leaflets and body portion. The valves have fewer sutures than conventional valves since the leaflets and body are formed together. The valves are inserted into a stent and secured with fewer sutures compared to traditional valves. The molding process allows shaping the leaflets with concavities and variations in thickness. The valves have improved efficiency and cost compared to hand-sewn valves with separate leaflets and body pieces.
11. Elliptical Multi-Valve Artificial Heart Valve with Saddle-Shaped Support Base
SHANGHAI CINGULAR BIOTECH CORP, 2023
An artificial heart valve design that reduces the risk of left ventricular outflow tract obstruction and improves fatigue life compared to traditional circular valves. The valve has multiple incompressible valves arranged on a saddle-shaped support base. The individual valves are connected at their seats to form an overall elliptical shape. This prevents compression of the aortic valve when the mitral valve is replaced. The reduced height and width of the multi-valve assembly compared to a single circular valve also reduces the risk of left ventricular outflow tract obstruction.
12. Prosthetic Tricuspid Valve with Asymmetrical Support Structures for Native Leaflet Grasping
INQB8 MEDICAL TECH LLC, INQB8 MEDICAL TECHNOLOGIES LLC, 2023
A prosthetic tricuspid valve that can be implanted in a native tricuspid valve without direct attachment to the annulus or chordae tendineae. The valve has asymmetrical support structures that grasp the native leaflets and allow the prosthetic valve to move with the native valve during the cardiac cycle. This biodynamic design preserves native annulus motion and prevents issues like heart block. The valve has leaflets, covers, and arms that attach to the native leaflets and surround the native annulus.
13. Polymer Composite Heart Valve with Frosted Surface Support and Three-Layer Valve Structure Featuring Modified Skirts and Spacer
Shandong Ruian Tai Medical Technology Co., Ltd., SHANDONG RUIANTAI MEDICAL TECHNOLOGY CO LTD, 2023
Polymer composite heart valve with improved durability, seal, and thrombus resistance compared to existing valves. The valve has a frosted surface support, a three-layer polymer valve with modified inner and outer skirts, and a spacer. The three-layer valve is made by stacking films with specific properties, such as modulus, water contact angle, and platelet adhesion, and treating the inner and outer skirts to prevent thrombus. The frosted support provides a rough surface for tissue ingrowth. The spacer between the valve and tissue prevents paravalvular leakage. The valve is prepared by vacuum pressing the stacked films at controlled temperatures.
14. Polymer Heart Valve with Curved Leaflets and Natural Open State Configuration
Shanghai Blue Sail Boa Medical Technology Co., Ltd., SHANGHAI BLUESAIL BOAO MEDICAL TECHNOLOGY CO LTD, 2023
Artificial heart valve made of polymer material that opens and closes naturally like a natural heart valve. The polymer leaflets are arranged in a configuration that allows the valve to be in an open position in its natural state. This eliminates the need for anticoagulant drugs and reduces the risk of bleeding compared to mechanical valves. The polymer leaflets have a curved shape with different upper curves to prevent premature closure. This allows the leaflets to deform and open more easily with blood flow compared to flat polymer valves.
15. Heart Valve Prosthesis with Tubular Braided Support and Interlaced Fabric Leaflets
Shanqian Biomaterials Technology Co., Ltd., YAMAZEN BIOLOGICAL MATERIALS TECHNOLOGY CO LTD, Shanqian (Zhuhai) Biomaterials Technology Co., Ltd., 2023
Heart valve prosthesis made of a tubular support member with braided outer layers and leaflets attached to the inner wall. The leaflets are made by interlacing inner warp and weft threads to form layers. The leaflet edges are entangled between the outer braided layers using the inner weft threads. This allows the valve to be made entirely of woven fabric instead of separate components sewn together. The braided outer layers provide structure while the interlaced leaflets allow valve motion. The woven construction reduces fatigue and allows customized leaflet shapes.
16. Prosthetic Heart Valve Leaflet Assembly with Asymmetrical Leaflets and Interlocking Commissure Tabs
Edwards Lifesciences Corporation, 2023
Prosthetic heart valve leaflet assembly with asymmetrical leaflets and commissure assembly configurations to improve durability and reduce wear compared to conventional symmetrical leaflet designs. The leaflets have tabs with vertical extensions that fold over adjacent leaflet tabs to form commissures.
17. Expandable Heart Valve Prosthesis with Outer-Coated Frame and External Leaflet Attachment
ANTERIS TECH CORP, ANTERIS TECHNOLOGIES CORP, 2023
Expandable heart valve prosthesis that aims to improve durability and hemodynamics compared to existing transcatheter valves. The prosthesis has a frame with an outer coating instead of the typical inner coating. The valve leaflets are attached to the outer coated frame instead of the inner frame. This allows the leaflets to fully open beyond the frame size in the expanded state, improving hemodynamics. The outer coating reduces frame-tissue contact and inflammation compared to inner coatings. The coating material can be biocompatible polymers, bovine/porcine tissue, or pericardium. The outer coated frame can have radiopaque markers for precise positioning during delivery.
18. Prosthetic Heart Valve with Conformable Cuff Incorporating Pleats, Biasing Elements, and Variable Thickness Regions
St. Jude Medical, LLC, 2023
Prosthetic heart valve with a unique cuff design to improve sealing, reduce leakage, and minimize impacts on surrounding tissue compared to traditional collapsible valves. The cuff has features like pleats, biasing elements, and movable sections to conform better to irregular anatomy and provide tighter engagement. The cuff can also have regions with varying thicknesses to match the native valve shape. This helps prevent leakage around the cuff and mitigate issues like mitral valve impingement.
19. Heart Valve Prosthesis with Asymmetric Leaflets and Separable Anchor Connectivity
BIOTRONIK AG, 2023
Heart valve prosthesis with a unique leaflet arrangement and connectivity between the valve and anchor components that allows separate replacement of the valve without removing the anchor. The valve has asymmetric leaflets that close the valve orifice in different angles. The leaflets are fixed to a conical support structure. The anchor has a skirt that folds around it and connects to the valve via seams. The valve and anchor are separated by the skirt folds, allowing valve replacement without anchor removal.
20. Prosthetic Heart Valve with Annular Frame and Partially Unsupported Leaflets
Edwards Lifesciences Corporation, 2023
A prosthetic heart valve designed to reduce tissue trauma and mechanical stress during implantation to avoid complications like rupture. The valve has an annular frame with leaflets that partially extend outside the frame at the inflow end. This unsupported portion of the leaflets connects to an outer skirt that extends beyond the frame. The skirt and outer leaflet edges avoid direct contact with the native anatomy, reducing trauma compared to fully frame-supported valves.
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Innovations in leaflet design are transforming prosthetic heart valves, making them more durable and effective. These advancements focus on reducing wear, enhancing blood flow, and ensuring long-term reliability. By addressing the challenges of material compatibility and structural demands, researchers are shaping a future where prosthetic heart valves provide better outcomes and improved quality of life for patients worldwide.