Variable-Sealing Heart Valve Prosthesis for Gradual Pressure Adaptation
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Solution Overview
Problem
Existing heart valve replacement devices cause sudden changes in pressure gradients upon implantation, leading to increased ventricular pump resistance and potential cardiogenic shock in patients with severe cardiac dysfunction, as they abruptly stop leaks, which the heart cannot immediately adapt to.
Innovation Solution
A heart valve prosthesis with a variable sealing function that allows for a defined amount of blood backflow when closed, using spacers, filters, or biodegradable materials to gradually adjust to the patient's physiology over time, reducing leakiness and adapting to the corrected anatomy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a heart valve prosthesis provides complete sealing immediately upon implantation, then valve function and prevention of backflow are improved, but ventricular pump resistance increases abruptly causing potential cardiogenic shock
Solution Approach 1:
The sealing function of the valve prosthesis is made dynamic rather than static. The sealing elements are designed to move and adapt over time, transitioning from an initial state that allows controlled backflow to a final state of complete sealing. This dynamic behavior enables the valve to provide reliable sealing function while avoiding abrupt increases in ventricular pump resistance during the adaptation period.
Solution Approach 2:
The valve prosthesis is designed with preliminary features that enable controlled backflow during the initial period after implantation. This preliminary action allows the heart to adapt gradually to the new valve anatomy, reducing the risk of cardiogenic shock. The controlled backflow mechanism is built into the valve structure from the beginning, providing a safe transition period before complete sealing is achieved.
2Object-affected harmful factors
If a heart valve prosthesis allows controlled backflow during adaptation period, then ventricular pump resistance is reduced and patient safety is improved, but sealing effectiveness is temporarily compromised
Solution Approach 1:
The valve prosthesis incorporates controlled backflow capability as a preliminary feature during the adaptation period. This allows the heart to gradually adjust to the new valve anatomy, reducing ventricular pump resistance and preventing sudden hemodynamic shifts. The controlled backflow mechanism is designed to be temporary and progressive, transitioning to complete sealing as the heart adapts.
Solution Approach 2:
The sealing elements are designed with dynamic properties that allow them to change their sealing characteristics over time. During the initial adaptation period, the sealing elements remain slightly open to permit controlled backflow, reducing ventricular pump resistance. Over weeks to months, the sealing elements progressively close more completely, improving sealing effectiveness while maintaining patient safety throughout the transition.
3Productivity
If the heart adapts quickly to a new valve anatomy, then treatment efficiency is improved, but the heart cannot accommodate the corrected anatomy without causing insufficiency
Solution Approach 1:
The valve prosthesis is designed with preliminary features that facilitate gradual adaptation of the heart to corrected anatomy. The controlled backflow mechanism allows the heart to adjust progressively over weeks to months, maintaining stable function throughout the adaptation period. This preliminary design prevents sudden hemodynamic shifts that could cause insufficiency while enabling the heart to accommodate the corrected anatomy.
Solution Approach 2:
The valve prosthesis utilizes parameter changes in its sealing elements to facilitate gradual adaptation. The sealing elements are designed to change their geometric parameters (opening size, contact area) over time, transitioning from an initial state that allows controlled backflow to a final state of complete sealing. This controlled parameter change enables the heart to adapt gradually to the corrected anatomy while maintaining reliable function throughout the transition period.
Data Source
AI summary
The disclosure relates to a heart valve prosthesis with a variable sealing function, a method for replacing a native heart valve with a heart valve replacement prosthesis with a variable sealing function and the use of a heart valve replacement prosthesis with a variable sealing function for treating a heart valve disorder.