Unidirectional Valvular Implant for Mitral Regurgitation
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Solution Overview
Problem
Heart valve regurgitation, particularly functional mitral regurgitation, occurs when the mitral valve leaflets fail to coapt properly, leading to backward leakage of blood, which impairs heart function and can progress to severe conditions like congestive heart failure if left untreated.
Innovation Solution
The use of unidirectional valvular implants, comprising a resilient frame and a valve, is proposed to prevent backflow into pulmonary veins by blocking the pulmonary vein orifices during systole, thereby addressing the issue of mitral valve regurgitation indirectly.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the mitral valve leaflets are structurally normal but fail to coapt properly causing regurgitation, then direct valve replacement or repair is complex and invasive, but indirect treatment by blocking pulmonary vein orifices is simpler and less invasive
Solution Approach 1:
The patent introduces an intermediary device (pulmonary vein occlusion device) that blocks the pulmonary vein orifices to prevent regurgitated blood from entering the pulmonary veins. This indirect approach avoids direct manipulation of the mitral valve while still achieving the therapeutic goal of preventing harmful backflow.
Solution Approach 2:
Instead of directly addressing the mitral valve leaflet coaptation problem, the invention inverts the approach by blocking the alternative pathway (pulmonary vein orifices) through which regurgitated blood would otherwise flow. This reverse thinking simplifies the treatment while maintaining effectiveness.
2Reliability
If unidirectional valvular implants are used to block pulmonary vein orifices during systole, then backflow into pulmonary veins is prevented, but the device complexity increases
Solution Approach 1:
The patent divides the treatment into separate functional components: a resilient frame for structural support and positioning, and a valve component for unidirectional flow control. This segmentation allows each component to be optimized independently while working together to prevent backflow.
Solution Approach 2:
The valvular implant is designed with dynamic characteristics, where the resilient frame can expand and contract in response to pressure changes during the cardiac cycle. The valve component dynamically opens during diastole to allow forward flow and closes during systole to prevent backflow, adapting to the pulsatile nature of blood flow.
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 implementation of these valvular implants effectively reduces the consequences of regurgitation by preventing blood from flowing back into the pulmonary veins, enhancing cardiac output, and reducing the risk of pulmonary edema.
Implementation Method 1
The frame can be made of a resilient material, such as a metal, and can be expandable from a compressed condition to an expanded condition
Implementation Method 2
The flaps can be configured to flex open to permit blood flow from the pulmonary veins into the atrium
Implementation Method 3
The flaps can be configured to close to block blood flow from the atrium into the pulmonary veins during systole
Data Source
AI summary
Valvular implants and blood vessel closure devices herein are configured to be positioned in the heart and to block regurgitant blood flow from the heart into blood vessels supplying blood to the heart. The device can include an expandable docking station configured to be installed in the left atrium of the heart, at least one valve retained in a docking portion of the docking station, and a fluid blocking material secured to the docking station and configured to surround the first and second pulmonary vein openings and provide a fluid seal around the at least one valve.