Asymmetrical Mitral Valve Prosthesis with Flexible Leaflets
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Solution Overview
Problem
Current mitral valve prostheses are unnatural in shape and rigid, leading to suboptimal hemodynamic performance, frequent surgeries, and anticoagulation requirements due to clotting issues, failing to mimic the native mitral valve's anatomy and function.
Innovation Solution
A prosthetic mitral valve with an asymmetrical, flexible ring and two leaflets that mimic the natural anatomy, featuring cords similar to chordae tendineae for blood flow regulation, made from 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 hemodynamic performance deteriorates and heart muscle recovery is impaired
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 valve annulus, and asymmetric leaflets with different sizes (anterior and posterior leaflets) to replicate the native valve's geometry. This asymmetric design allows the prosthesis to conform to the natural cardiac anatomy, improving hemodynamic performance and enabling better heart muscle recovery while maintaining manufacturability through 3D printing techniques.
2Strength
If mechanical valve components are used, then structural strength is improved, but blood cloting increases and anticoagulation is required
Solution Approach 1:
The patent changes the material parameters from rigid mechanical materials to flexible, biocompatible materials such as bovine pericardium and biocompatible polymers. This parameter change maintains sufficient structural strength for valve function while eliminating the blood cloting issue associated with mechanical components, as the natural tissue-like materials do not promote coagulation. The flexible materials also allow the valve to move with the natural distortion of heart muscle during the cardiac cycle.
3Ease of manufacture
If a symmetric three-leaflet design is used, then manufacturing is simplified, but anatomical accuracy deteriorates
Solution Approach 1:
The patent employs asymmetry by creating a prosthesis with an asymmetric ring and two asymmetric leaflets (anterior and posterior) of different sizes, accurately replicating the natural mitral valve anatomy. This asymmetric design provides precise anatomical accuracy while maintaining ease of manufacture through customized 3D printing processes that can produce complex asymmetric geometries from digital models derived from patient imaging.
4Manufacturing precision
If a flexible asymmetric design is used, then anatomical accuracy is improved, but device complexity increases
Solution Approach 1:
The patent utilizes flexible shells and thin films by constructing the prosthesis from flexible materials such as bovine pericardium and biocompatible polymers that can deform and move with the natural distortion of heart muscle during the cardiac cycle. This flexibility enables the prosthesis to achieve high anatomical accuracy and functional performance while the modular nature of the flexible construction keeps the overall device complexity manageable through 3D printing fabrication.
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.