Enhancing Heart Valve Performance Through Advanced Leaflet Designs
14 patents in this list
Updated:
The leaflets in prosthetic heart valves are essential for directing blood flow and mimicking the natural function of the heart. Their design and durability are critical to ensuring effective valve performance and longevity. Innovations in materials, structures, and attachment techniques have paved the way for leaflets that resist wear, reduce clotting risks, and enhance blood flow.
The challenges and advancements in leaflet design for prosthetic heart valves are discussed on this page.
1. 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.
2. 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.
3. Prosthetic Heart Valve Leaflets with Biomimetic Structure and Elastic Fiber Integration
EPYGON, 2023
Prosthetic heart valve leaflets that mimic the structure and function of natural heart valves to provide long-term durability and prevent valve failure. The leaflets are designed to replicate the composition, thickness, and shape of natural valve leaflets to optimize valve mechanics, competence, and coaptation. This involves balancing stiffness and flexibility, having redundant tissue at the leaflet tips for closure, and having elastic fibers extending from the hinge to the coaptation edge.
4. Prosthetic Heart Valve with Elastic Support Structure and Load-Transferring Synthetic Leaflets
FOLDAX, INC., 2022
Prosthetic heart valve design with a support structure that actively assists in valve opening and closing. The valve has synthetic leaflets and an elastic support structure with projections and a base. The leaflets transfer load to the elastic support during closing, which stores the energy. When the pressure decreases, the elastic support automatically starts opening in a precursory transition using the stored energy. This provides a natural valve-like pressure wave.
5. Composite Prosthetic Heart Valve Leaflets with Dual-Layer Structure for Controlled Tissue Ingrowth
W. L. Gore & Associates, Inc., 2022
Flexible synthetic leaflets for prosthetic heart valves that promote tissue ingrowth to reduce complications like thrombus formation. The leaflets have a composite structure with a porous synthetic membrane filled with a material that inhibits tissue growth. This inner layer is covered by an outer layer that promotes tissue ingrowth. The inner layer prevents excessive tissue growth, while the outer layer encourages normal tissue ingrowth. The composite structure allows tissue ingrowth while avoiding excessive tissue entanglement in the leaflets.
6. Prosthetic Heart Valve Attachment Mechanisms with Leaflet Mobility Enhancement
Edwards Lifesciences Corporation, 2022
Improved attachment mechanisms for prosthetic heart valves that reduces stress concentrations, abrasion, and stretching of the valve leaflets compared to conventional attachment techniques. The attachments allow the leaflets to move more freely relative to the frame during expansion and contraction. One mechanism involves suturing the leaflet scalloped edges to struts perpendicular to the scallop line, allowing sliding movement. Another mechanism uses a separate flexible element to connect the scalloped edge to the frame.
7. Transcatheter Prosthetic Heart Valve with Thermoformed Polymer Leaflets and Woven Stent Integration
Ohio State Innovation Foundation, Georgia Institute of Technology, Colorado State University Research Foundation, 2022
A durable transcatheter prosthetic heart valve that avoids calcification and degradation issues of existing prosthetic valves. The valve has optimized leaflet and stent designs, woven attachment to the stent, and reinforcements. The leaflets are thermoformed from polymer material into an optimized shape. The leaflets weave through the stent frame to anchor in place. This prevents shearing forces that can damage fixed-edge valves. Fibers or other reinforcements are added to enhance valve durability.
8. Prosthetic Heart Valve with Fibrous Reinforced Composite Leaflets Containing Electrospun Fibers in Polyisobutylene Urethane Matrix
Boston Scientific Scimed, Inc., 2022
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.
9. Collapsible Prosthetic Heart Valve with Longitudinal Stent and Commissure Features
St. Jude Medical, Cardiology Division, Inc., 2022
Collapsible prosthetic heart valve that can be delivered into a patient less invasively than valves that are not collapsible. The valve includes a stent extending in a longitudinal direction, the stent being formed of a plurality of struts forming cells and having a plurality of commissure features, a collapsed condition and an expanded condition.
10. Composite Leaflet Material with Expanded Fluoropolymer and Elastomer Integration for Artificial Heart Valves
W. L. Gore & Associates, Inc., 2021
Composite leaflet material for artificial heart valves that have improved durability and reduced wrinkling compared to conventional materials. The composite material is formed by combining an expanded fluoropolymer membrane with an elastomer. The elastomer fills the pores of the expanded fluoropolymer. The composite leaflets made from this material exhibit elongation while maintaining strength and then increase in stiffness beyond a certain strain. This provides flexibility during valve opening without excessive wrinkling, and resistance to tearing or failure during long-term cyclic operation.
11. Prosthetic Heart Valve with Expandable Stent Frame and Collapsible Leaflets
St. Jude Medical, LLC, 2021
Prosthetic heart valve design with collapsible leaflets that can be delivered via a catheter. The valve has an expandable stent frame and flexible leaflets that can collapse for delivery, then re-expand once deployed in the heart. The leaflets are secured to the stent frame and have features to prevent damage from abrasion. The valve design enables less invasive delivery compared to traditional open-heart surgery.
12. Synthetic Flexible Leaflet Prosthetic Heart Valve with Composite Material and Isosceles Trapezoid Attachment Zone
W. L. Gore & Associates, Inc., 2021
Highly durable synthetic flexible leaflet prosthetic heart valve design that prevents premature failure. The valve uses a composite leaflet material with an expanded fluoropolymer membrane and an elastomeric material. It also has a unique leaflet shape with an isosceles trapezoid attachment zone on the frame. The composite material and shape prevent leaflet delamination and tearing. The valve has two frames, a nested leaflet frame and an outer frame, to provide structural support and prevent leakage. It can be delivered via transcatheter or surgical methods.
13. Prosthetic Heart Valve with U-Shaped Transition Area and Collapsible Design for Transcatheter Delivery
JenaValve Technology, Inc., 2020
A prosthetic heart valve designed for transcatheter delivery to treat heart valve disorders. The valve has a unique shape with a U-shaped transition area connecting the leaflets to the skirt. This shape reduces stresses during valve motion compared to separate leaflets and skirt. The valve is made of natural tissue or synthetic material, and can be made in one piece for easier manufacturing. The valve also has features like tapered leaflets, redundant coaptation, and fastening holes to aid in attachment to the stent. The valve is collapsible for delivery via catheter.
14. Prosthetic Heart Valve Leaflets with Internal Guiding Elements for Controlled Bending
W. L. Gore & Associates, Inc., 2014
Leaflets for prosthetic heart valves that improve performance and longevity compared to conventional valves. The leaflets have internal guiding elements made of stiffer material sandwiched between layers of film. The guiding elements control the leaflet bending shape as it opens and closes, preventing tight radius bending that causes failure. This improves hemodynamics by allowing larger orifice areas and reduces fatigue by preventing folding.
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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.