Mechanical Valve Design in Prosthetic Hearts
Mechanical heart valves face durability challenges under constant cyclic loading, with over 40 million openings and closures per year at pressures up to 150 mmHg. Current designs show wear patterns at pivoting points and experience complications from blood flow turbulence, with 2-5% of patients developing thrombotic events annually despite anticoagulation therapy.
The core engineering challenge lies in creating valve designs that balance mechanical durability against optimal hemodynamics while minimizing blood damage and thrombogenicity.
This page brings together solutions from recent research—including porous metallic leaflets, pyrolytic carbon assemblies with removable bearing blocks, and amorphous metal alloy implementations. These and other approaches focus on improving long-term reliability while reducing thrombotic complications in clinical use.
1. Prosthetic Heart Valve with Commissure-Attached Stress-Isolating Patches
ST JUDE MEDICAL CARDIOLOGY DIV INC, ST JUDE MEDICAL CARDIOLOGY DIVISION INC, 2024
Prosthetic heart valve design with improved stress isolation and leaflet durability in transcatheter valve replacement procedures. The valve has patches attached to the commissure attachment features of the stent to absorb forces during valve operation. The patches can be rigid or billowing to provide stress isolation. This reduces mechanical stresses on the leaflet tissue, especially in cobalt-chromium stents where the leaflets are coupled directly to the stent. The patches are disposed around the commissure features and the leaflets are attached to the patches instead of the stent.
2. Artificial Heart Valve with Walled Groove Leaflet Fixation Mechanism
JIANGSU TRULIVE MEDTECH CO LTD, 2023
Artificial heart valve design with improved durability and reduced calcification compared to traditional valves. The valve has a unique fixation mechanism for the leaflets to attach to the stent. The stent has a walled groove that the leaflets pass through and connect to. This allows evenly fixing the leaflets to the stent without wrinkles. This reduces stress concentration and calcification compared to sewing the leaflets to the stent. The smooth leaflet attachment prevents tears and calcification from blood flow impact.
3. Prosthetic Heart Valve with Tissue Bumpers on Stent Struts
MEDTRONIC INC, 2023
Prosthetic heart valve design with tissue bumpers to reduce leaflet abrasion on the stent frame during valve expansion. The bumpers are made of tissue strips wrapped around specific struts of the stent. This protects the leaflets from contacting the stent frame and reduces wear. The tissue strip wraps start at the axial strut and extend along inflow struts to prevent leaflet-frame contact during valve opening.
4. Biomechanically Anchored Artificial Tricuspid Valve with Axial Mobility and Asymmetric Support Structures
INQB8 MEDICAL TECH LLC, INQB8 MEDICAL TECHNOLOGIES LLC, 2023
A biomechanically anchored artificial tricuspid valve that improves function and reduces complications compared to conventional replacement valves. The valve is designed to biomechanically secure to the native tricuspid valve leaflets instead of attaching to the annulus. This allows the prosthetic valve to move axially within the native valve during the cardiac cycle. The anchoring reduces motion differences compared to the native valve, avoiding conduction blockages. The valve also has asymmetric support structures, pleated atrium covers, and leaflets that contact each other to prevent leakage. The biomechanical anchoring reduces blood flow obstruction and thrombus formation compared to rigidly fixing the prosthetic valve to the annulus.
5. Cardiac Valve Prosthesis with Armature Featuring Alternating Anchoring Formations and Support Posts
Corcym S.r.l., 2023
A cardiac valve prosthesis with an armature design to prevent folding and improve function when implanted in irregular annuli. The prosthesis has a multi-leaflet valve supported by an armature with an annular part and arched struts. The annular part alternates sets of outwardly protruding anchoring formations with support posts around the circumference. This alternating arrangement prevents folding when implanted in irregular annuli like bicuspid valves or flat sinuses. The alternating anchoring and support distribution prevents excessive bending and folding forces on the annular part.
6. Prosthetic Heart Valve with Collapsible Stent and Conformable Cuff Featuring Variable Radii and Sealing Enhancements
St. Jude Medical, LLC, 2023
Prosthetic heart valve design with features to reduce complications and improve outcomes when replacing native valves. The valve has a collapsible stent body, valve elements, and a cuff that expands to anchor the valve. The cuff has sections with different radii to conform to irregular native tissues. It also has features like pleats, biasing elements, and pockets to promote better sealing and reduce leakage. The cuff can be turned inside out to position the free end around the annulus. This allows compact collapsing for delivery and expansion during implantation. The cuff can also be bonded to native tissues using energy sources like lasers.
7. 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.
8. Prosthetic Heart Valve with Pore-Structured Metal Leaflets and Collapsible Stent
St. Jude Medical, Cardiology Division, Inc., 2022
Prosthetic heart valve with metal leaflets having pores instead of using biological leaflets. The valve has a collapsible stent, cuff, and metal leaflets that coapt to close the valve and pivot open. The leaflets are made of braided wire or mesh with pores instead of using biological tissue. This makes the valve durable and less prone to erosion than valves with biological leaflets.
9. Prosthetic Heart Valve with Suture-Based Leaflet Attachment and Self-Tightening Structures
EDDERHOLTZ LIFE SCIENCE CO, 2022
Prosthetic heart valve design with improved attachment of the leaflets to the frame that reduces thrombosis risk compared to fabric-based attachment methods. The leaflets have rounded tips that are secured to the frame struts using a primary suture threaded through the tip in an in-and-out pattern. Secondary sutures surround the struts and lock the primary suture in place. This forms self-tightening structures that contract under tension to secure the leaflet tips. The lack of fabric strips between the leaflets and frame reduces tissue ingrowth and thrombosis risk.
10. Artificial Heart Valve Prosthesis with Dual-End Leaflet Attachment for Reduced Radial Force
SHANGHAI 10 BILLION MEDICAL SCIENCE AND TECH LIMITED CO, SHANGHAI 10 BILLION MEDICAL SCIENCE AND TECHNOLOGY LIMITED CO, 2022
An artificial heart valve prosthesis design that improves the durability and lifespan of the valve by preventing excessive forces on the valve leaflets during operation. The valve has a unique configuration where the leaflets attach at the top to the inflow end of the stent and at the bottom to the outflow end. This allows the leaflets to open without forming an angle with the blood flow direction, reducing the radial component force on the leaflets. This avoids interference with the stent inner wall and friction that shortens valve life. The leaflets remain fixed at the top and bottom ends during closure to prevent excessive force.
11. Prosthetic Heart Valve with Interconnected Struts and Obliquely Oriented Yarn Skirts
EDWARDS LIFESCIENCES CORP, 2022
Prosthetic heart valve design to improve durability and reduce wear compared to conventional prosthetic valves. The valve has a frame with interconnected struts and leaflets with undulating cusp edges. The leaflet cusps connect to the struts via skirts. The skirts have yarns that intersect at oblique angles to the strut axis. This angled orientation provides larger skirt overlap and contact with the struts, increasing durability by reducing wear compared to parallel or perpendicular yarns.
12. Artificial Heart Valve Prosthesis with Stent Windows and Leaflet Protrusions Covering Joints
SHANGHAI MICROPORT CARDIOFLOW MEDTECH CO LTD, 2022
Artificial heart valve prosthesis with improved durability and reduced stress on the valve leaflets. The valve has a stent with windows, joints, and protrusions. The leaflets have protrusions that cover the joints and windows. This disperses stress and prevents calcification at the leaflet-stent connections. Additionally, an intermediate piece covers the joints to reduce friction and wear.
13. Prosthetic Heart Valve with Reinforced Leaflets Incorporating Variable Thickness and Stress-Resistant Material
St. Jude Medical, Cardiology Division, Inc., 2021
Prosthetic heart valve with improved durability for younger, lower-risk patients. The valve has leaflets with a reinforcing material like sutures or a rigid skeleton attached to the biological tissue leaflets. This reinforcement provides strength to areas of the leaflets with higher stresses like the belly attachment points. It prevents tearing or hole formation compared to all-biological leaflets. The reinforced leaflets can better withstand forces without excessive thickness that would impede collapsibility. The valve also allows variable leaflet thickness to reduce volume while concentrating reinforcement where needed.
14. Heart Valve Prosthesis with Flexible Leaflets and Conically Tapered Skirt for Adaptable Anchoring
BIOTRONIK AG, 2021
Heart valve prosthesis with flexible leaflet and skirt components that can adapt to specific locations like the aorta. The prosthesis has a valve member with flexible leaflets and a valvular support structure, and an anchoring member with a flexible skirt. The leaflets and skirt can be made from materials like pericardium or bacterial cellulose. The skirt tapers conically like the valve member. This allows the prosthesis to conform to aortic geometry during implantation. The skirt and leaflets can be connected by sewing to prevent displacement. The skirt folds around the anchoring structure for fixation. A releasable connection between the valve and anchoring allows prosthesis replacement without removing the entire implant.
15. Mechanical Heart Valve with Annular Support Extensions and Inclined Upper Bearings for Leaflet Guidance
NOVOSTIA SA, 2021
A mechanical heart valve with improved leaflet guidance and wear resistance. The valve has an annular support with extensions and lower bearings, plus upper bearings for each leaflet. The upper bearings have inclined intermediate sections that the leaflet contacts as it opens. This prevents concentrated loading and wear at the leaflet edges. The lower bearings prevent excessive leaflet motion in the closed position. The recessed extensions guide the leaflet ends during closure. This allows the leaflets to rotate about apexes of the upper bearings when opening, avoiding wear on the rotational sections. The leaflets contact the bearings at locations away from their rotation points.
16. Mechanical Prosthetic Heart Valve with Rotatable Flaps and Curved Recess Supports
NOVOSTIA SA, 2021
Mechanical prosthetic heart valve with reduced wear and improved guidance of the flaps compared to conventional valves. The valve has three movable flaps that can rotate around axes perpendicular to the valve axis. Each flap has two support points at the leading edge contacting the lower supports during closure. This prevents wear at the sharp leading edge. The supports also rest against the flap in the closed position to prevent escaping. The flap thickness is greater between the supports than at the leading edge. The supports have curved recesses for guiding the flap ends during motion.
17. Prosthetic Heart Valve with Composite Leaflet Structure and Securement Features
W L GORE & ASSOCIATES INC, 2020
Crushable and expandable prosthetic heart valves that can be delivered minimally invasively and have improved reliability. The valves have a leaflet structure with a porous synthetic polymer membrane layer sandwiched between synthetic polymer membrane layers. The porous layer allows flow and prevents backflow. The valves also have features like loops, retaining elements, and guide protrusions to secure the leaflets during expansion. The porous membrane prevents collapse during delivery and expansion. The composite leaflet construction improves crushability, expandability, and performance reliability compared to solid leaflets.
18. Artificial Heart Valve with Leaflets Connected to Axial Joint for Stress Distribution and Fabricated by Folding or Weaving Techniques
DSM Intellectual Property Asset Management Ltd., 2019
Artificial heart valve design that improves durability and reduces wear compared to conventional valves. The valve has leaflets that can coapt without excessive stretching. The leaflets are connected to a supporting element along a joint extending from the free edge parallel to the valve axis. This distributes stress over length instead of concentrating at the free edge. The leaflets can coapt even when not pulsating, with engagement height >0.1 mm along the edge. The valve can be made by folding, weaving, or double weaving fabric to form the leaflets and support. This allows leaflet engagement without extreme elongation.
19. Artificial Heart Valve with Intermediate Fixing Member for Leaflet Attachment
Jian Technology (Shenzhen) Co., Ltd., 2019
Artificial heart valve with improved durability compared to conventional designs. The valve has a leaflet that connects to the frame using an intermediate fixing member instead of directly suturing the leaflet to the frame. This prevents tearing and damage to the leaflet sutures as the valve opens and closes. The fixing member has a receiving groove that holds the leaflet edge, allowing the leaflet to move freely. The fixing member is also sutured to the frame separately. This reduces stress and strain on the leaflet-frame junction compared to direct suturing.
20. Prosthetic Heart Valve with Compliant Central Support, Internal Load-Reducing Valve, and Thrombus-Holding Capsular Closure Member
TENDYNE HOLDINGS INC, 2018
A prosthetic heart valve design that addresses problems like insufficient sealing, leakage, poor cooperation, tissue erosion, and thrombosis. The valve has an external support component and an internal valve component. The external support component has a more compliant central portion compared to the ventricular ends. This allows the valve to seat firmly in the annulus. The internal valve component reduces leaflet load. Additionally, the valve has a capsular closure member to hold thrombi. An atrial Halo electrode raises the valve above the annulus plane to improve leaflet closure.
21. Prosthetic Heart Valve Leaflets with Pre-Stressed Fiber Reinforcement Encapsulated in Composite Materials
BOSTON SCIENTIFIC SCIMED INC, 2017
Prosthetic heart valves with improved durability and mechanical properties using pre-stressed reinforcement elements like fibers. The valve leaflets contain composite materials with pre-stressed fibers encapsulated between polymer layers. The fibers are pre-stressed before coupling to the layers. This provides initial tension that balances the valve's compression forces during use. The pre-stressed fibers increase durability by reducing overstretching and maintain desired leaflet elongation.
22. Artificial Heart Valve with Convex-Concave Leaflet Geometry and Annular Support Structure
THE DAVID J WHEATLEY DISCRETIONARY TRUST, 2016
An artificial heart valve with improved haemodynamic performance and reduced durability issues compared to conventional designs. The valve has leaflets that move more freely and open fully to minimize obstruction and regurgitation. The leaflets have a unique shape with an outwardly convex portion near the attachment points, followed by a concave portion. This allows full opening and prevents wrinkling or buckling during valve operation. The valve also has a base structure with an annular support that prevents needle puncture during surgery. The leaflets are formed by dip coating the structure in a liquid that solidifies. This allows precise shaping and thickness control.
23. Prosthetic Heart Valve with Multi-Layer Stent Comprising Hard Inner and Elastic Outer Rings
Shanghai Cingular Biotech Corporation, 2015
A prosthetic heart valve with a stent design that improves stability and longevity compared to conventional designs. The valve has a multi-layer stent with an inner ring made of a harder material and an outer ring made of a more elastic material. This configuration allows the rings to compress and expand together, preventing displacement between the stent and the valve wire. The annular shape is maintained even under stress, reducing wrinkles and wear on the leaflets. The stent layers can be made of materials like Elgiloy alloy and polyester fabric.
24. Collapsible Prosthetic Heart Valve with Annular Sealing Members and Flared Anchoring Stent
ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC., 2015
Collapsible prosthetic heart valves with improved sealing and anchoring properties. The valves have a stent with features that prevent retrograde blood leakage and prevent movement of the valve in the heart. The stent has expanded and collapsed conditions. In the expanded condition, it has annular sealing members at the inflow and outflow ends, flared portions, and anchor members. In the collapsed condition, these extend further away from the ends. This provides better sealing and anchoring while compressing. The valve assembly has leaflets attached to the expanded stent. The sealing members have non-planar shapes in the expanded condition. The flared portions and anchor members extend further from the ends in collapse. This reduces contact with the heart tissue. The sealing members have larger diameters than the stent. The flared portions and anchors extend further from the ends in collapse.
25. Prosthetic Heart Valve with Elastic Tissue Supports and Integrated Leaflet Attachment
EPYGON SAS, 2015
A prosthetic heart valve design with improved durability and reduced stress on the leaflets. The valve has multiple tissue supports attached to the inner surface of the stent or annulus. The leaflet is attached between the supports or integrally formed with one support. This allows the leaflet to flex between the supports instead of bending over edges like in conventional designs. The supports are preferably elastic to further reduce stress on the leaflets. This evenly distributes stress along the leaflet length for better long-term durability compared to stitching directly to the stent.
26. Implantable Blood Pump with Oscillating Valves and Rigid Closure Members Driven by Reciprocating Mechanism
MARLIN STEPHEN HEILMAN, DOUGLAS J. KOEBLER, CHARLES ROBERT KOHLER, 2013
Implantable pump systems assist blood flow and treat heart failure. The pump systems have moving valves that oscillate back and forth to propel blood. The valves have rigid closure members that can be actively moved to close or open. This allows precise control over the pumping action. The valves are driven by a reciprocating mechanism. The pumps can be fully implanted in the aorta or other vessels to boost blood flow and relieve heart failure symptoms.
27. Prosthetic Heart Valve Sizer with Flexible Annular Wall and Outer Ring
Medtronic, Inc., 2009
A flexible sizer for accurately determining the proper size of a prosthetic heart valve to be implanted during heart valve replacement surgery. The sizer has a body with an outer ring and an annular wall that extends from the ring. The annular wall has a flexibility similar to the annular extension of the prosthetic heart valve. This allows the sizer to better match the flexibility of the actual prosthetic valve when inserted into the patient's heart valve annulus, providing a more accurate size evaluation.
28. Percutaneous Prosthetic Valve with Layered Metal Film Flaps and Cell-Permeable Graft Covering
Advanced Bio Prosthetic Surfaces, Ltd., 2007
Percutaneous prosthetic valves for implantation in mammals like humans, using metal or pseudometal films to make the valve flaps and graft covering. The valve flaps are made from layered metal films to improve mechanical properties compared to wrought metal. The graft covering has openings to allow cell migration but prevent fluid flow. The metal valve flaps are coupled to a stent and biased to close. The metal films provide improved mechanical strength, corrosion resistance, and fatigue compared to wrought metal. The layered flaps also have better crack propagation resistance due to interface microroughness. The metal films are delivered endovascularly without removing the native valve.
29. Bi-Leaflet Prosthetic Heart Valve with Pyrolytic Carbon Leaflets and Molded Plastic Annulus
Harischandra K. Mhatre, 2005
A bi-leaflet prosthetic heart valve made of pyrolytic carbon and plastic components that provides improved durability, reliability, and performance compared to prior art valves. The valve assembly avoids issues like component warping, cracking, dislodging, and poor function by using molded plastic for the annulus and carbon for the leaflets and bearing blocks. This allows assembly without flexing and prevents deformities or slippage. The carbon components provide strength and closure while the plastic annulus allows flexibility. The carbon and plastic components work cooperatively for long-term durability and function.
30. Pyrolytic Carbon Bi-Leaflet Prosthetic Heart Valve with Removable Tapered Bearing Blocks
Harischandra K. Mhatre, 2005
A pyrolytic carbon bi-leaflet prosthetic heart valve with improved reliability, durability, ease of assembly, and reduced cost compared to prior art designs. The valve uses a ring structure with removable and replaceable bearing blocks instead of integrated bearing surfaces. The blocks have tapers that mate with the ring's tapers for secure retention. This allows separate fabrication and replacement of the blocks, preventing damage to the pyrolytic carbon coating during assembly. The ring has recesses for the leaflet ears, but the other block provides the opposite bearing. This reduces contact between the ears and the ring, preventing slipping or dislodgement. The removable blocks also enable adjustment of axial play for optimal hinge engagement.
31. Mechanical Heart Valve with Pivoting and Translating Occluders and Contoured Orifice
Medical Carbon Research Institute L.L.C., 1998
Mechanical heart valve design with pivoting occluders to minimize blood flow turbulence and thrombosis. The valve has a longer axial length compared to traditional designs. The occluders pivot and translate to open and close, following the direction of blood flow. This reduces turbulence compared to fixed occluders. The valve body orifice is contoured to eliminate the usual zone of separation that causes turbulence. The extended length, pivoting occluders, and shaped orifice aim to reduce pressure drop and thrombosis risk in mechanical heart valves.
32. Heart Valve with Integrally Formed Ring and Teardrop Cross-Section Support Strut
Shiley, Inc., 1982
Improving blood flow through heart valves by integrally forming the valve ring and closing support strut to eliminate welds and allow optimal cross-section shapes. The strut can have a teardrop cross-section with increased area for strength, as the integral formation allows machining without distortion. This reduces flow obstruction compared to circular wires. Eliminating the weld fillet also allows smaller ring heights. The integral formation improves valve structural integrity and flow simultaneously.
Mechanical and metallic prosthetic heart valves are an essential part of modern cardiac care, offering durable and effective solutions for heart valve replacement. Innovations in material science and engineering continue to improve their performance, longevity, and safety. As research advances, these valves are set to deliver even better outcomes for patients, enhancing their quality of life.
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