Percutaneous Mitral Valve Prosthesis With Magnetic Clamping
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Solution Overview
Problem
Existing transcatheter mitral valve therapies face challenges due to the complex structure and function of the mitral valve, including a D-shaped annulus, lack of a fibrous annular structure, variability of leaflet and subvalvular apparatus anatomy, and proximity to critical structures like the left ventricular outflow tract and coronary arteries, making minimally invasive replacement difficult.
Innovation Solution
A percutaneous prosthetic device with a cylindrically-shaped body and a clamping ring, anchored by ferromagnetic elements, is deployed using a minimally invasive technique, allowing magnetic closure to mimic the mitral valve's function by expanding during diastole to allow blood flow and contracting during systole to prevent backflow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If open-heart surgery is used to replace the mitral valve, then the valve replacement can be performed with direct access, but the procedure risks damaging heart tissue and requires cardioplegia
Solution Approach 1:
The patent uses a delivery catheter as an intermediary device to transport the prosthetic valve to the mitral valve position through the vasculature, avoiding direct surgical access to the heart. The catheter navigates through blood vessels and delivers the valve percutaneously, eliminating the need for open-heart surgery and associated risks to heart tissue
Solution Approach 2:
The patent replaces the mechanical open-heart surgical approach with a percutaneous catheter-based delivery system. Instead of physically accessing the heart through incisions and stopping the heart with cardioplegia, the system uses a flexible catheter that can be guided through the body's natural pathways to deliver the valve replacement
2Duration of action of stationary object
If a mechanical valve is used, then the valve lasts longer and is not subject to wear, but blood thinning medications are required to prevent clotting
Solution Approach 1:
The patent changes the material parameter of the prosthetic valve from traditional mechanical or bioprosthetic materials to a shape memory alloy that can dynamically change its physical state. The valve transitions between a compressed delivery state and an expanded functional state, allowing for minimally invasive deployment while maintaining mechanical durability without the same clotting risks as traditional mechanical valves
3Object-generated harmful factors
If a bioprosthetic valve is used, then no blood thinning medications are required, but the valve will wear over time and require further surgery
Solution Approach 1:
The patent employs shape memory alloy, a composite material with unique properties combining the durability and structural integrity of metals with the ability to undergo reversible phase transformations. This allows the valve to achieve the longevity of mechanical valves while potentially offering improved hemocompatibility, eliminating the need for blood thinning medications like bioprosthetic valves
4Loss of time
If a percutaneous procedure is used, then patient recovery is faster and hospitalization is shorter, but the complex mitral valve structure makes replacement difficult
Solution Approach 1:
The patent segments the prosthetic valve into modular components that can be independently manipulated and deployed. The valve is divided into a frame structure and leaflet components that can be assembled and positioned separately through the catheter, simplifying the deployment process despite the complexity of the mitral valve anatomy
Solution Approach 2:
The patent utilizes the dynamic nature of the shape memory alloy to allow the valve to transition from a static compressed state during delivery to a dynamic expanded state at the implantation site. This dynamic transformation enables the valve to adapt to the complex mitral valve anatomy and function properly after deployment
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device provides stable, effective mitral valve replacement with minimal invasiveness, reducing complications and improving patient outcomes by maintaining proper blood flow dynamics.
Implementation Method 1
the waist portion comprising the plurality of ferromagnetic elements and the clamping ring supporting the plurality of ferromagnetic spheres to be drawn together magnetically
Data Source
AI summary
A device for replacing a mitral valve includes a substantially cylindrically-shaped body having a top portion, a bottom portion, and a waist portion disposed therebetween and having ferromagnetic elements arranged circumferentially, and the top portion, waist portion, and bottom portion defining an aperture extending therethrough for allowing blood flow; and a clamping ring formed of a ferromagnetic material and supporting a plurality of ferromagnetic spheres thereon.