Coaptation Aid for Mitral Valve Leaflet Stabilization
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Solution Overview
Problem
Current methods for repairing mitral valve regurgitation, particularly in anatomies where the anterior and posterior leaflets are significantly spaced or dynamically misaligned, face challenges in effectively grasping and stabilizing the leaflets for edge-to-edge repair, leading to difficulties in reducing regurgitation due to procedural complexity and limited access.
Innovation Solution
A kit comprising a coaptation aid with a coaptation catheter featuring an expandable member, such as a self-expanding scaffold or balloon, that facilitates positioning of the anterior leaflet proximate the posterior leaflet via a retrograde approach, combined with a fixation system to couple the leaflets, allowing for improved leaflet grasping and stabilization during edge-to-edge repair.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional fixation systems are used without coaptation aid, then the device complexity is reduced, but the ease of operation deteriorates due to difficulty in grasping and stabilizing misaligned leaflets
Solution Approach 1:
The coaptation aid acts as an intermediary device between the fixation system and the valve leaflets. It includes a positioning element that can be positioned between the anterior and posterior leaflets to stabilize them in a coapting configuration, making the leaflets easier to grasp and fixate without requiring complex manipulation of the fixation system itself
Solution Approach 2:
The coaptation aid enables preliminary positioning and stabilization of the leaflets before the fixation system is activated. By first establishing the coapting configuration with the positioning element, the subsequent fixation operation becomes simpler and more reliable
2Adaptability or versatility
If the anterior and posterior leaflets are significantly spaced or dynamically misaligned, then the anatomical variability is increased, but the ease of operation deteriorates due to limited access for repair
Solution Approach 1:
The coaptation aid incorporates a positioning element that can be dynamically adjusted to accommodate varying leaflet positions and alignments. The element can be positioned at different locations along the leaflets to adapt to anatomical variability, maintaining ease of operation across different patient anatomies
Solution Approach 2:
The coaptation aid is designed to be universally applicable to various anatomical configurations. The positioning element can engage with different leaflet positions, making the system versatile for treating anatomical variability while maintaining consistent ease of operation across different cases
3Productivity
If edge-to-edge repair is performed without coaptation aid, then the procedural steps are reduced, but the productivity deteriorates due to increased procedural complexity and time
Solution Approach 1:
The coaptation aid serves as a mediator that simplifies the edge-to-edge repair procedure by providing a stable platform for leaflet positioning. This reduces procedural complexity by eliminating the need for complex manipulation techniques, thereby improving productivity
Solution Approach 2:
By performing preliminary positioning of the leaflets using the coaptation aid before the actual repair operation, the procedure becomes more efficient. The preliminary action establishes the correct geometry early, reducing the time and complexity required for the subsequent fixation steps
Data Source
AI summary
Kit includes coaptation aid and fixation system for repair of leaflets of a heart valve. Coaptation aid includes coaptation catheter having an expandable member at a distal end thereof adapted to be introduced to a left ventricular outflow tract of a heart via a retrograde approach. Expandable member has a delivery configuration with a reduced cross-dimension and a deployed configuration with an expanded cross-dimension adapted to contact a ventricular side of a first leaflet of a heart valve and position the first leaflet generally proximate a coapting configuration with a second leaflet. Fixation system includes a delivery catheter having a distal end, and a fixation device removably coupled to the distal end of the delivery catheter and is adapted to couple the first leaflet to the second leaflet of the heart valve. Methods for fixation of native leaflets of a heart valve using a coaptation aid also disclosed.