Retrievable Valve Clip With Superelastic Arms for Leaflet Coaptation
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Solution Overview
Problem
Existing treatments for mitral valve regurgitation, such as the MitraClip device, are invasive and complex, limiting their applicability to elderly and frail patients, and there is a need for improved minimally invasive devices that can effectively seal native heart valves and reduce regurgitation without open heart surgery.
Innovation Solution
The development of prosthetic devices and methods that utilize flexible, superelastic arms with atraumatic barbs and passive closure mechanisms to grasp and coapt heart valve leaflets in a parallel or vertical relationship, allowing for minimally invasive procedures and reversible implantation without entanglement, and optionally incorporating visualization techniques for precise device placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the MitraClip device is used to treat mitral valve regurgitation, then valve sealing function is improved, but device complexity and invasiveness increase
Solution Approach 1:
The device is divided into separate functional components: an anchor component that secures to the valve annulus and a leaflet engagement component that grasps the leaflets. This segmentation allows each component to be optimized independently and simplifies the overall device architecture while maintaining effective valve sealing.
Solution Approach 2:
The invention extracts the essential function of valve sealing from complex mechanical clipping mechanisms and achieves it through a simplified anchor-engage system that relies on anatomical positioning and basic grasping forces, eliminating unnecessary complexity while preserving reliability.
2Reliability
If traditional surgical repair or replacement is performed, then valve function is restored, but patient trauma and recovery time increase
Solution Approach 1:
The device serves as an intermediary between the defective valve and the desired functional outcome, providing a minimally invasive bridge that restores valve function without requiring open heart surgery. The catheter-based delivery system acts as an intermediary pathway to implant the device through peripheral vessels.
Solution Approach 2:
The device incorporates flexible, compliant materials that conform to the native valve anatomy, allowing minimally invasive delivery while effectively restoring valve function. The flexibility enables passage through small access sites while maintaining structural integrity for functional restoration.
3Reliability
If complex multi-component devices are used, then valve sealing effectiveness is improved, but ease of operation and implantation simplicity deteriorate
Solution Approach 1:
The anchor and leaflet engagement functions are merged into a single integrated device that can be deployed as one unit, simplifying the implantation procedure while maintaining effective valve sealing. The combined design eliminates the need for multiple separate implantation steps.
Solution Approach 2:
The device incorporates self-positioning and self-adjusting features that automatically align with the valve anatomy during deployment, reducing the skill level and complexity required for successful implantation while maintaining effective sealing.
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
These devices enable effective sealing of heart valves to reduce regurgitation through minimally invasive procedures, maintaining valve function and allowing for retrieval without tissue impairment, thus providing a safer and more adaptable treatment option for patients.
Implementation Method 1
flexible, superelastic arms with atraumatic barbs and passive closure mechanisms to grasp and coapt heart valve leaflets
Data Source
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AI summary
A clip for immobilizing leaflets of a cardiac or venous valve includes a hub having a pair of tangle resistant spring-biased outer arms coupled to an inferior end of the hub. A pair of tangle- resistant spring-biased inner arms lies adjacent to the outer arms and is coupled to a superior end of the hub. The clip may incorporate adjustable spacers and retrievable post implantation. A delivery catheter is used to position the valve clip adjacent a target valve while the outer and inner arms are biased in an opened position relative to each other. After the valve leaflets are located between the opened outer and inner arms, the biasing forces may be released to allow the clip to self-close over the valve leaflets.