Leaflet Clip Deployment for Minimally Invasive Heart Valve Repair
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Solution Overview
Problem
Existing heart valve disease treatments, such as invasive surgical interventions and complex pinching techniques, fail to effectively repair damaged chordae tendineae, leading to improper valve closure and blood regurgitation, necessitating minimally invasive solutions for heart valve repair.
Innovation Solution
A leaflet clip delivery and deployment system featuring a clip spreader with atrial and ventricular spreader arms and clip arms, allowing for sliding engagement and disengagement, and a leaflet clip with a flex zone that biases into a closed configuration for clamping onto heart valve leaflets, facilitating the deployment of artificial chordae tendineae.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If invasive surgical intervention is used to repair heart valves, then the valve can be directly accessed and repaired, but the patient faces high surgical risks and requires open chest surgery
Solution Approach 1:
A delivery catheter serves as an intermediary device, transporting the leaflet clip through the bloodstream to the heart valve without requiring open surgery. The catheter enables minimally invasive access to the valve, eliminating the need for chest opening while maintaining repair capability
Solution Approach 2:
The invention replaces the traditional mechanical surgical approach (direct manual manipulation during open surgery) with a catheter-based delivery system that uses fluid dynamics and remote actuation to deploy the repair device at the target site
2Shape
If complex pinching techniques are used to create dual smaller openings, then the leaflet diameter is reduced, but the technique does not provide a durable solution and fails to repair damaged chordae tendineae
Solution Approach 1:
The leaflet clip is segmented into two separate arms (first and second arms) that can independently engage with the leaflet tissue. This segmentation allows the clip to apply distributed clamping force while maintaining the ability to repair chordae tendineae through the integrated delivery system
Solution Approach 2:
The delivery catheter acts as an intermediary that enables the attachment of artificial chordae tendineae to the leaflet through the clip mechanism, providing a durable repair solution that addresses the root cause of valve failure rather than just modifying leaflet shape
3Shape
If resection and surgical ring implantation are performed to reduce annulus diameter, then leaflet coaptation is improved, but the procedure is complex and does not address damaged chordae tendineae
Solution Approach 1:
The invention extracts the annulus reduction function from the complex surgical ring implantation procedure. The leaflet clip itself performs the diameter reduction by clamping the leaflet, eliminating the need for separate ring implantation surgery while maintaining the therapeutic effect
Solution Approach 2:
The invention merges multiple functions (leaflet clamping, chordae tendineae repair, and annulus reduction) into a single integrated device and delivery system, simplifying the overall procedure while providing comprehensive valve repair
4Ease of operation
If a leaflet clip with sliding engagement mechanism is used, then the clip can be easily deployed and repositioned, but the retention mechanism becomes more complex
Solution Approach 1:
The retention elements incorporate movable features that transition between engaged and disengaged states. The first retention element moves from an initial engaged position to a disengaged position, enabling dynamic control of clip retention and release during the procedure
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
Enables minimally invasive repair of heart valves by securely clamping leaflets and deploying artificial chordae tendineae, improving valve function and reducing blood regurgitation without the risks of open surgery.
Implementation Method 1
a leaflet clip with a flex zone that biases into a closed configuration for clamping onto heart valve leaflets
Data Source
AI summary
A clip and a clip deployment and delivery system. The clip may be engaged with a clip spreader such that simple relative movement, such as sliding movement, between the clip and clip spreader causes the clip and clip spreader to disengage from each other. A clip spreader actuator may be coupled to one arm of the clip spreader, extend distally around a distal end of the clip spreader, proximally along the other clip spreader arm, and to a proximal end at which the actuator may be controlled to open or close the clip spreader. The clips may be leaflet clips having teeth on one arm thereof and bumps on another arm thereof. The arms of the leaflet clip may be biased into a closed configuration by a flex zone which has an expanded portion extending laterally away from only one of the clip arms.