Coapting Element for Cardiac Valve Regurgitation Reduction
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Solution Overview
Problem
Heart valve regurgitation, caused by improperly functioning heart valves, leads to decreased heart efficiency, reduced blood circulation, and increased stress, often requiring invasive open-heart surgery for treatment, which is not suitable for all patients.
Innovation Solution
A valved regurgitation reduction device with a coapting element that adjusts size to allow flow during diastole and prevent flow during systole, coupled with a valve that opens and closes accordingly, is implanted to reduce regurgitation through the heart valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open-heart surgery is performed to replace or repair the diseased valve, then the heart valve function is restored, but the invasiveness and surgical risk increase significantly
Solution Approach 1:
The patent introduces a coapting element as an intermediary device that is implanted into the valve annulus to facilitate proper leaflet coaptation. This intermediary structure allows the natural valve leaflets to function correctly without requiring complete valve replacement through open-heart surgery, thereby restoring valve function while avoiding the invasiveness of traditional surgical approaches
Solution Approach 2:
The device utilizes the patient's own heart valve leaflets and annular tissue to achieve valve repair. The coapting element is designed to work with the existing biological structures, allowing the natural valve components to perform their function of opening and closing, thereby eliminating the need for artificial valve grafts and reducing surgical complexity
2Productivity
If the coapting element is sized to provide a gap during diastole for proper flow, then blood circulation is improved, but the risk of regurgitation during systole increases
Solution Approach 1:
The coapting element is designed with dynamic characteristics that allow it to adapt to the changing pressure conditions during the cardiac cycle. During diastole, when pressure is lower, the element maintains a configuration that provides adequate gap for blood flow. During systole, when pressure increases, the element dynamically adjusts to enhance sealing, thereby resolving the contradiction between maintaining flow and preventing regurgitation
Solution Approach 2:
The device utilizes changes in pressure and flow parameters during the cardiac cycle to achieve its dual function. The coapting element's geometry and material properties are designed to respond to pressure changes, automatically adjusting the gap size between diastole and systole to optimize both circulation and sealing without requiring active control mechanisms
Data Source
Figure 1A
Figure 1B
Figure 2A
AI summary
Heart valve regurgitation is reduced by sizing a coapting element to provide a gap between the coapting element and a heart valve when the heart is in a diastolic phase. The size of the coapting element is also selected such that the heart valve seals against the coapting element when the heart is in the systolic phase. The coapting element allows flow through the coapting element when the heart is in a diastolic phase and prevents flow through the coapting element when the heart is in a systolic phase.