Variable Offset Fixation Clip for Mitral Valve Leaflets
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Solution Overview
Problem
Current medical devices for treating mitral valve regurgitation lack the ability to accommodate varying leaflet thicknesses, leading to procedural challenges and potential tissue injury during transcatheter edge-to-edge valve repair.
Innovation Solution
A fixation device with rotatable arms and gripping elements that can be variably offset to accommodate different leaflet thicknesses, featuring adjustable axis offsets and compliant hinges to ensure secure coaptation without causing tissue damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a fixation device with fixed gripping elements is used, then the device structure is simple, but it cannot accommodate varying leaflet thicknesses leading to tissue injury
Solution Approach 1:
The gripping elements are made rotatable about their respective axes, allowing them to dynamically adjust their position relative to the arms. This rotational freedom enables the gripping elements to accommodate varying leaflet thicknesses by rotating to appropriate angles, transforming a static fixed-structure problem into a dynamic adjustable solution.
Solution Approach 2:
The fixation device is divided into independent rotatable components: arms and gripping elements that can rotate independently about their hinge points and respective axes. This segmentation allows each component to be optimized and adjusted independently, enabling the gripping elements to adapt to different tissue thicknesses without requiring complete device redesign.
2Object-affected harmful factors
If the gripping elements are fixed in position, then the device is easier to manufacture, but it causes tissue injury when leaflet thickness varies
Solution Approach 1:
By making the gripping elements rotatable rather than fixed, the device dynamically adapts to the actual tissue thickness encountered during the procedure. This prevents tissue injury by allowing the gripping elements to position themselves at appropriate angles for the specific leaflet thickness, rather than forcing a fixed geometry that may be inappropriate for varying tissue conditions.
Solution Approach 2:
The rotational capability of the gripping elements changes the geometric parameters of tissue engagement. By rotating the gripping elements about their axes, the device can alter the effective gripping angle and position to match the specific leaflet thickness, thereby preventing tissue injury through parameter adaptation rather than fixed geometry.
3Ease of operation
If standard fixation devices are used, then the procedure is straightforward, but repositioning and removal of fixation devices is not allowed
Solution Approach 1:
The rotatable arms and gripping elements provide dynamic repositioning capability before final fixation. The device can be adjusted and repositioned by rotating the arms about hinge points and gripping elements about their axes, allowing optimization of the fixation position before engagement, which is particularly valuable in transcatheter procedures where precision is critical.
Data Source
AI summary
Fixation device for fixation of heart valve leaflets includes an elongate central member defining a longitudinal axis of the fixation device and first and second arms rotatable about at least one arm hinge point between an open position and a closed position. The fixation device further includes a first gripping element rotatable about a first gripping element axis of rotation to capture a first leaflet of a heart valve between the first gripping element and the first arm, and a second gripping element rotatable about a second gripping element axis of rotation to capture a second leaflet of a heart valve between the second gripping element and the second arm. At least one of the first gripping element axis of rotation and the second gripping element axis of rotation is variably offset from the arm hinge point by an axis offset distance defined along the longitudinal axis.