Prosthetic Heart Valve Leaflet Clip Capture Mechanism
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Solution Overview
Problem
Prosthetic heart valves often face interference from native valve leaflets, which can obstruct blood flow and reduce the effective orifice area, leading to improper operation and turbulence, especially as the native leaflets stiffen due to calcification.
Innovation Solution
A prosthetic heart valve system with self-expanding wire frame bodies and leaflet clips that can transition between configurations to capture and position native valve leaflets, ensuring they do not obstruct the flow path and maintain a desirable blood flow profile, using a control element to facilitate this positioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a prosthetic heart valve is implanted to replace a native valve, then the valve function is improved, but native valve leaflets may become disposed between the prosthetic valve and the myocardium, interfering with blood flow and reducing the effective orifice area
Solution Approach 1:
The patent extracts and removes the harmful native valve leaflets from the flow path by capturing them with the leaflet clips and positioning them away from the prosthetic valve orifice, thereby eliminating the interference while preserving the prosthetic valve function
Solution Approach 2:
The leaflet clips serve as intermediary elements between the prosthetic valve and the native leaflets, capturing and positioning the native leaflets to prevent them from interfering with blood flow while allowing the prosthetic valve to function properly
2Object-affected harmful factors
If native valve leaflets are captured and positioned away from the flow path, then blood flow is improved, but additional components (leaflet clips and control elements) are required, increasing device complexity
Solution Approach 1:
The patent merges the leaflet clips and control elements into an integrated assembly that can be delivered and deployed together with the prosthetic valve, reducing the overall complexity compared to separate components while achieving the goal of native leaflet capture and positioning
3Ease of operation
If the prosthetic valve is delivered in a compressed state, then it can be inserted through the delivery catheter, but the valve body must be expanded in the heart, requiring precise control during deployment
Solution Approach 1:
The patent employs a self-expanding valve body that transitions from a compressed delivery state to an expanded functional state automatically upon release from the delivery catheter, reducing the need for complex manual expansion control while maintaining ease of delivery
Data Source
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Figure 2b
AI summary
A prosthetic heart valve includes a self-expanding wire frame body, a valve disposed in the body, a leaflet clip coupled to the body, and a control element operably coupled to the leaflet clip. The body has a proximal end and a distal end. The leaflet clip is configured to be transitioned between a first configuration in which the prosthetic valve can be inserted into a heart, and a second configuration in which the leaflet clip is disposed to capture a native valve leaflet between the leaflet clip and the wire frame body when the body is disposed in a native annulus of an atrioventricular valve of a heart. The control element extends from the leaflet clip through a ventricle of the heart and out a wall of the ventricle to allow a user to transition the leaflet clip from its first configuration to its second configuration.