Mitral Valve Prosthesis with Leaflet Immobilization
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Solution Overview
Problem
Existing mitral valve replacement techniques are traumatic, often inoperable for high-risk patients, and can lead to complications such as increased heart wall stress, peri-valvular leaks, and reduced left ventricular function due to disruption of the mitral annulus-papillary muscle continuity.
Innovation Solution
A mitral valve prosthesis with a self-expanding frame and engagement arms that immobilize native leaflets, maintaining the MA-PM continuity, along with anchor attachment points for secure fixation, allowing for minimally invasive implantation and reduced trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional surgical mitral valve replacement is performed, then the valve can be replaced, but it causes trauma, interrupts MA-PM continuity, and increases mortality in high-risk patients
Solution Approach 1:
The patent uses a delivery device as an intermediary tool that enables minimally invasive implantation of the mitral valve prosthesis. The delivery device allows the prosthesis to be introduced through a catheter-based approach rather than open surgery, thereby reducing trauma while maintaining valve replacement success. This intermediary mechanism resolves the contradiction by providing a less invasive pathway for achieving the same therapeutic outcome.
Solution Approach 2:
The patent replaces the traditional mechanical surgical system (open heart surgery, heart-lung machine) with a minimally invasive catheter-based delivery system. This substitution eliminates the need for thoracotomy and cardiopulmonary bypass, significantly reducing surgical trauma and mortality risk while still achieving effective valve replacement. The mechanical approach is replaced with a percutaneous, less invasive delivery mechanism.
2Reliability
If surgical mitral valve replacement is performed, then the valve can be replaced, but it leads to disruption of MA-PM continuity and reduced left ventricular function
Solution Approach 1:
The patent extracts and preserves the native MA-PM continuity structure during valve replacement. By using a minimally invasive approach with careful tissue preservation, the procedure removes only the diseased valve tissue while leaving the annulus and papillary muscle intact. This extraction approach maintains the structural integrity and functional continuity of the MA-PM apparatus, resolving the contradiction between valve replacement and structural preservation.
Solution Approach 2:
The patent applies local quality changes by selectively replacing only the valve leaflets while preserving the surrounding healthy tissue structures. The prosthesis is designed to interface locally with the annulus and papillary muscles without disrupting their continuity. This localized approach ensures that the MA-PM complex maintains its structural stability and functional integrity, addressing the contradiction between complete valve replacement and structural preservation.
3Shape
If a small artificial valve is used, then the valve fits the annulus, but it limits mitral flow during exercise due to high cardiac output requirements
Solution Approach 1:
The patent employs a self-expanding frame structure that dynamically adapts to the annular geometry. The frame expands to the appropriate size during deployment, ensuring optimal fit while maintaining adequate orifice area for blood flow. This dynamic expansion mechanism allows the valve to achieve both proper sizing and sufficient flow capacity, resolving the contradiction between valve fit and flow productivity.
Solution Approach 2:
The patent utilizes shape memory alloy materials that undergo parameter changes in response to body temperature. The frame transitions from a compressed delivery state to an expanded functional state, changing its dimensional parameters to match the annulus geometry. This parameter transformation enables the valve to achieve optimal fit while maintaining adequate orifice area, addressing the contradiction between valve sizing and flow capacity.
4Strength
If a rigid artificial valve structure is used, then the valve provides structural support, but it prevents physiologic contraction of the posterior wall during systole
Solution Approach 1:
The patent incorporates flexible, compliant materials in the valve construction, particularly in the leaflets and supporting structures. This flexibility allows the valve to accommodate the dynamic mechanical stresses of cardiac contraction while maintaining structural integrity. The flexible design enables the posterior wall to contract physiologically during systole without being constrained by a rigid valve structure, resolving the contradiction between structural support and contractile stability.
5Reliability
If the chordae are severed during valve replacement, then the valve can be replaced, but it reduces chamber function by 30%
Solution Approach 1:
The patent extracts and preserves the chordae tendineae during the valve replacement procedure. By using a minimally invasive approach that avoids chordal transection, the procedure maintains the integrity of the subvalvular apparatus. This extraction approach allows valve replacement while preserving chordal function, thereby maintaining chamber performance and resolving the contradiction between valve replacement and chamber function preservation.
Data Source
AI summary
A valve prosthesis and methods for implanting the prosthesis are provided. The prosthesis generally includes a self-expanding frame and two or more engagement arms. A valve prosthesis is sutured to the self-expanding frame. Each engagement arm corresponds to a native mitral valve leaflet. At least one engagement arm immobilizes the native leaflets, and holds the native leaflets close to the main frame. The prosthetic mitral valve frame also includes two or more anchor attachment points. Each anchor attachment point is attached to one or more anchors that help attach the valve prosthesis to the heart.