Asymmetrical Mitral Valve Prosthesis with Flexible Leaflets
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Solution Overview
Problem
Current mitral valve prostheses are unnatural in shape, rigid, and often require multiple surgeries due to limited durability, leading to heart strain and failure, with existing solutions failing to replicate the natural anatomy and function of the human mitral valve effectively.
Innovation Solution
A prosthetic mitral valve with an asymmetrical, flexible ring and two leaflets that mimic the natural anatomy, featuring cords similar to native chordae tendineae for blood flow regulation, constructed from flexible materials like bovine pericardium and biocompatible polymers, customized to match individual patient anatomy through advanced imaging techniques.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a rigid circular prosthesis is used, then manufacturing is simplified, but the natural anatomy of the heart is distorted and hemodynamic performance deteriorates
Solution Approach 1:
The patent applies asymmetry by designing the prosthesis with an asymmetric ring structure that mirrors the natural asymmetric shape of the human mitral annulus, and asymmetric leaflets with different sizes (anterior and posterior leaflets) to replicate the natural valve geometry. This asymmetric design allows the prosthesis to conform to the natural heart anatomy, improving hemodynamic performance while maintaining manufacturability through 3D printing techniques.
Solution Approach 2:
The patent changes the geometric parameters of the prosthesis by transitioning from a standard circular shape to a customized asymmetric shape that matches the patient's specific annular dimensions and leaflet configurations. This parameter customization is achieved through 3D printing with precise control over the ring's eccentricity and leaflet dimensions, thereby optimizing blood flow dynamics while keeping the manufacturing process straightforward.
2Strength
If a mechanical valve with rigid components is used, then structural strength is improved, but blood clots form on the valve requiring anticoagulation medication
Solution Approach 1:
The patent employs flexible shells and thin films by constructing the valve components from flexible materials such as biocompatible polymers and pericardium that can deform and flex with the natural motion of the heart. This flexibility prevents the formation of rigid surfaces where blood clots prefer to adhere, while the structural integrity is maintained through the flexible nature of the materials that allow dynamic movement without compromising strength.
Solution Approach 2:
The patent changes the material parameters by using flexible, biocompatible materials instead of rigid mechanical components. The flexible ring and leaflets are made from materials like pericardium and biocompatible polymers that resist blood clotting while providing sufficient structural strength through their flexible mechanical properties, eliminating the need for anticoagulation medication.
3Object-generated harmful factors
If a biological valve is used, then blood clotting risk is reduced, but durability is limited requiring frequent replacement
Solution Approach 1:
The patent applies composite materials by combining multiple materials with complementary properties to create a valve that achieves both low clotting risk and high durability. The valve structure integrates flexible biocompatible polymers, pericardium, and other natural materials in a composite construction that leverages the clot-resistant properties of biological materials while enhancing their durability through optimized composite结构设计, potentially extending the valve lifespan significantly.
Solution Approach 2:
The patent uses flexible shells and thin films made from durable biocompatible materials that maintain their structural integrity over time while resisting blood clotting. The flexible ring and leaflets are constructed from materials like pericardium and biocompatible polymers that provide both longevity and clot resistance, addressing the durability limitation of traditional biological valves.
4Reliability
If a custom asymmetric prosthesis is designed to match patient anatomy, then hemodynamic performance is improved, but manufacturing complexity increases
Solution Approach 1:
The patent changes the design parameters by using 3D printing technology that allows direct fabrication of custom asymmetric geometries from digital models derived from patient imaging. This parameter customization is achieved through software-based design that translates patient-specific annular dimensions and leaflet configurations into precise 3D prints, thereby optimizing hemodynamic performance while the 3D printing process manages the manufacturing complexity through automated fabrication.
Solution Approach 2:
The patent applies copying by creating a 3D digital copy of the patient's native mitral valve anatomy from imaging data, and then fabricating the prosthesis as a physical replica of this digital model. This copying approach allows the complex asymmetric geometry to be precisely reproduced without manual fabrication complexity, as the 3D printing process automatically generates the custom shape from the digital blueprint.
5Stability of the object's composition
If rigid materials are used for the prosthesis, then structural stability is improved, but the heart muscle surrounding the prosthesis does not recover well
Solution Approach 1:
The patent uses flexible shells and thin films made from biocompatible materials that can deform and flex with the natural motion of the heart. This flexibility allows the prosthesis to move synchronously with the surrounding heart muscle, reducing mechanical stress and inflammation at the interface, thereby improving heart muscle recovery. The structural stability is maintained through the flexible nature of the materials that provide durable, long-lasting performance while adapting to cardiac movements.
Data Source
AI summary
A mitral valve prosthesis to be implanted in a heart, comprises an asymmetrical ring, the asymmetrical ring is dimensioned to mimic a native mitral annulus of a patient; an anterior flexible leaflet and a posterior flexible leaflet, said leaflets suspended from the asymmetrical ring and configured to substantially coapt with each other; and at least four sets of cords, each set of cords attached to the anterior or posterior leaflet on a first end and attached into a cap on a second end, the cap is configured to be attached onto papillary muscles of the heart on another end of the cap.