Catheter Coaptation Aid for Spaced Mitral Leaflet Grasping
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing methods for repairing heart valves, particularly the mitral valve, face challenges in effectively grasping and stabilizing leaflets due to varying anatomies and erratic motion, leading to difficulties in reducing regurgitation, especially when the leaflets are significantly spaced or dynamically move away from each other.
Innovation Solution
A catheter assembly with a coaptation aid featuring a lever and actuation assembly that includes an atraumatic tip and gripper assemblies, allowing for remote transition between delivery and deployed configurations to stabilize and grasp leaflets, facilitating edge-to-edge repair by positioning and capturing both leaflets.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional leaflet grasping methods are used, then the procedure is simple, but the ability to stabilize leaflets in challenging anatomies is insufficient
Solution Approach 1:
The catheter assembly is divided into functional segments: a delivery catheter shaft, a deployable lever with coaptation aid, and gripper assemblies. This segmentation allows the complex stabilization function to be achieved through coordinated action of simpler, specialized components rather than a single complex structure.
Solution Approach 2:
The lever is designed to transition dynamically between a delivery configuration (aligned with catheter shaft) and a deployed configuration (extending transversely). This dynamic transformation enables the same structure to serve both delivery and stabilization functions, improving reliability without permanently increasing complexity.
2Ease of operation
If the lever is extended to reach spaced leaflets, then leaflet grasping effectiveness is improved, but the device profile increases
Solution Approach 1:
The lever transitions from a compact delivery configuration where it is aligned with the catheter shaft to a deployed configuration where it extends transversely. This dynamic positioning allows the lever to achieve the necessary reach for spaced leaflets only when needed, maintaining a small profile during delivery.
Solution Approach 2:
The lever extends in a transverse dimension perpendicular to the catheter shaft axis when deployed. This dimensional change allows the coaptation aid to reach spaced leaflets effectively without increasing the longitudinal profile of the delivery system, as the extension occurs in a different spatial dimension.
3Measurement precision
If the catheter assembly is designed for remote actuation, then operational precision is improved, but the actuation mechanism complexity increases
Solution Approach 1:
The actuation assembly replaces complex mechanical transmission systems with a pull-wire mechanism that can be remotely actuated. This substitution enables precise control of the lever deployment from a distance while simplifying the overall actuation mechanism through the use of flexible wire transmission rather than rigid mechanical linkages.
4Object-affected harmful factors
If the atraumatic tip is designed to contact leaflets, then tissue safety is improved, but the grasping force capability is reduced
Solution Approach 1:
The atraumatic tip serves as an intermediary element that contacts the leaflet surface to stabilize it during grasping. This intermediary design allows force transmission for stabilization while the tip's atraumatic properties protect the tissue from injury, separating the functions of force application and tissue protection.
Solution Approach 2:
The tip is designed with localized atraumatic properties at the surface that contacts the leaflet, while the rest of the lever structure maintains sufficient rigidity and force capability. This local quality differentiation allows the tip to be tissue-friendly without compromising the overall grasping force capability of the lever assembly.
Data Source
AI summary
Catheter assembly with a coaptation aid for repair of leaflets of a heart valve includes an elongate catheter shaft adapted to be positioned transvascularly proximate a heart valve and a lever coupled to the catheter shaft. The lever has a hinge to transition the lever between an elongate delivery configuration generally aligned longitudinally with the catheter shaft and a deployed configuration extending transversely from the catheter shaft. The lever also includes an atraumatic tip at a distal end thereof and adapted to contact a distal side of a native leaflet of the heart valve when the catheter shaft is positioned proximate the heart valve and the lever is in the deployed configuration, and an actuation assembly coupled to the lever to remotely transition the lever between the delivery configuration and the deployed configuration. Method for fixation of native leaflets of a heart valve using the catheter assembly also disclosed.