Mitral Valve Leaflet Fixation Device with Biased Arms
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Solution Overview
Problem
Mitral regurgitation occurs when the native mitral valve fails to close properly, leading to blood flowing back into the left atrium, which can cause fatigue, lightheadedness, and eventually compromise heart function.
Innovation Solution
A leaflet fixation device with a unitary elongate body featuring a proximal neck portion and a distal portion with arms, biased towards a closed configuration to grasp valve leaflets, is used. The device includes tissue retention features and is delivered using a tool with a spreader mechanism to independently translate the arms between open and closed configurations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a fixation device is used to secure valve leaflets, then regurgitation is reduced and cardiac performance is improved, but the device complexity increases due to the need for multiple arms and tissue retention features
Solution Approach 1:
The fixation device is divided into multiple arms (first arm, second arm, etc.) that can independently engage tissue, allowing the device to secure multiple valve leaflets simultaneously while maintaining a modular structure that manages complexity
Solution Approach 2:
The arms are configured to be nestable within each other when in the retracted position, allowing the complex multi-arm structure to be collapsed into a compact form for delivery through catheters, thus managing device complexity during storage and delivery
2Reliability
If the arms are biased towards a closed configuration to grasp valve leaflets, then tissue retention is enhanced, but the force required to open the arms increases
Solution Approach 1:
A delivery tool with a spreader mechanism acts as an intermediary to apply the necessary force to open the arms against their bias, allowing the arms to be opened during delivery without requiring excessive force from the operator, while the arms maintain their biased closed configuration for reliable tissue retention after deployment
3Reliability
If tissue retention features are added to penetrate and secure tissue, then tissue engagement is improved, but the risk of tissue damage increases
Solution Approach 1:
The tissue retention features (barbs, hooks, teeth, tines) are localized to specific regions on the arms and proximal neck portion, allowing tissue engagement only at designated points rather than along the entire surface, which improves targeted tissue engagement while minimizing unnecessary tissue damage
Solution Approach 2:
The arms are designed to be movable between retracted and extended configurations, allowing the tissue retention features to be positioned dynamically - retracted during delivery to avoid damage, and extended after positioning to engage tissue securely
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 device effectively secures valve leaflets, reducing regurgitation and improving cardiac performance by reducing the size of the valve opening and enhancing tissue retention without unduly affecting the valve's operation.
Implementation Method 1
the arm being biased towards a closed configuration where the second tissue engaging surface may be retained adjacent to the first tissue engaging surface by a bias force
Data Source
AI summary
A valve fixation device may comprise a unitary elongate member that is biased towards a closed configuration wherein at least a pair of tissue engaging surfaces of the elongate member are held adjacent to each other by a bias force. The bias force is at least equal to a valve leaflet grasping force, enabling the fixation device to grasp and retain leaflets as part of cardiac treatment. A delivery tool including a spreader may independently translate the tissue engaging surfaces to enable cardiac leaflets to be captured and retained by and/or between the tissue engaging surfaces. The valve fixation device may include at least two arms, each of which may be independently controlled to grasp and capture opposing leaflets of a valve, such as the anterior and posterior leaflets of a mitral valve, to reduce the size of the valve opening and improve cardiac performance.