Fixation Device Flexure Portion Mitral Valve Leaflet Stress
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Solution Overview
Problem
Existing fixation devices for treating mitral valve regurgitation face challenges in reliably grasping leaflets with dynamic, chaotic, or severely degenerative anatomical features, leading to uneven tissue stress and potential complications.
Innovation Solution
A fixation device with a central element and a distal portion featuring moveable arms and legs, including a contact portion that can flex within a specific angle range to reduce uneven leaflet tension and stress, and a gripping element to capture native leaflets.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If a fixation device uses rigid arms to grasp valve leaflets, then the device provides stable structural support, but it creates uneven tissue stress and fails to adapt to dynamic or chaotic anatomical features
Solution Approach 1:
The patent applies the dynamics principle by transforming the rigid arm structure into a dynamic system with flexure portions that can adapt to varying anatomical conditions. The arms include flexure portions that allow controlled movement and adjustment, enabling the fixation device to accommodate dynamic or chaotic leaflet anatomy while maintaining stable fixation. This dynamic capability allows the device to respond to tissue movement and anatomical variations without creating uneven stress concentrations.
Solution Approach 2:
The patent implements parameter changes by modifying the mechanical properties of the arm structure through flexure portions. These flexure portions change the stiffness and flexibility parameters of the arms, allowing them to transition from rigid to compliant behavior. This parameter modification enables the arms to conform to irregular anatomical surfaces and distribute tissue stress more evenly, improving both reliability and adaptability.
2Device complexity
If a fixation device uses fixed contact portion angle, then the device structure is simple, but it cannot reduce uneven leaflet tension in patients with degenerative anatomical features
Solution Approach 1:
The contact portion angle is made dynamic through the flexure portion mechanism. Instead of being fixed, the contact portion can adjust its angle relative to the central axis within a specific range (approximately 5 to 30 degrees) in response to anatomical variations. This dynamic adjustment capability allows the device to automatically compensate for uneven leaflet tension without requiring complex control systems, maintaining relative structural simplicity while eliminating harmful stress concentrations.
Solution Approach 2:
The patent changes the contact portion angle parameter from a fixed value to a variable parameter that can adjust within a defined range. The flexure portion enables this parameter change in response to anatomical conditions, allowing the contact portion to optimize its engagement angle with the leaflet tissue. This parameter variability directly addresses uneven tissue stress by distributing forces more evenly across the contact interface.
3Ease of manufacture
If a fixation device lacks flexure capability, then the device is easier to manufacture, but it fails to grasp leaflets with dynamic or chaotic anatomical features reliably
Solution Approach 1:
The flexure portion is integrated into the arm structure as an inherent dynamic element rather than a separate complex mechanism. This design allows the arms to naturally flex and adapt to anatomical variations through their structural geometry, maintaining manufacturing simplicity while achieving reliable grasping of dynamic or chaotic leaflet tissue. The flexure capability is built into the basic arm design rather than requiring additional actuating mechanisms.
Solution Approach 2:
The patent employs flexible structural elements (flexure portions) within the arms that provide the necessary compliance for reliable tissue grasping. These flexure portions act as flexible elements that can bend and conform to the irregular surfaces of degenerative or dynamic leaflet anatomy, enabling reliable engagement without complicating the manufacturing process. The flexible geometry allows the rigid-looking arms to adapt to complex anatomical features.
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 achieves more reliable leaflet grasping and reduced tissue stress by allowing the contact portion to flex, thereby improving the efficacy of mitral valve repair and reducing the risk of complications.
Implementation Method 1
a flexure portion configured to enable the contact portion in the selected position to move within a flex angle range between an undeformed contact portion angle relative to the central axis and a flexed contact portion angle relative to the central axis
Data Source
AI summary
A fixation device for fixation of tissue includes a central element defining a central axis. The fixation device also includes a distal portion that includes an arm coupled to the central element and a leg operatively coupled to the arm. The arm is moveable to a selected position between a fully open position and a fully closed position. The leg is configured to move the arm to the selected position. The arm includes a contact portion for engaging tissue. The distal portion also includes a flexure portion configured to enable the contact portion in the selected position to move within a flex angle range between an undeformed contact portion angle relative to the central axis and a flexed contact portion angle relative to the central axis. The fixation device further includes at least one gripping element moveable relative to the at least one arm to capture tissue therebetween.