Cardiac Valve Tissue Compression Device for Residual Regurgitation
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Solution Overview
Problem
Existing cardiac valve repair methods, such as interventional clips, often fail to completely eliminate regurgitation due to anatomical constraints and the risk of valve stenosis, particularly in cases where conventional clips cannot be deployed effectively at small gaps between valve commissures or between clips and commissures.
Innovation Solution
Development of an interventional device with flexible arms and a self-centering delivery catheter that can compress cardiac valve tissue at targeted gaps, allowing for precise tensioning and compression to reduce regurgitation, even in small anatomical spaces, and an anchor for tissue ingrowth to prevent displacement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional clips are deployed to repair cardiac valve, then regurgitation is reduced, but residual regurgitation remains and valve stenosis risk increases
Solution Approach 1:
The device divides the compression function into multiple segments: compression arms for applying force, tensioning elements for maintaining separation, and anchoring components for securing position. This segmentation allows the device to reduce regurgitation through controlled compression while preventing stenosis through distributed force application and maintained leaflet mobility.
Solution Approach 2:
The device changes the physical parameters of valve repair by applying controlled compressive forces through spring-loaded arms while simultaneously maintaining tensile forces through detachable tensioning elements. This dual parameter approach (compression + tension) enables effective regurgitation reduction without the excessive compression that causes stenosis.
2Reliability
If conventional clips are used for valve repair, then coaptation is improved, but deployment is impossible in small gaps between commissures or clips
Solution Approach 1:
The device incorporates dynamic elements including spring-loaded compression arms that can expand and contract, detachable tensioning elements that can be engaged or released, and flexible delivery catheters that can navigate small gaps. This dynamic design allows the device to adapt to varying gap sizes and anatomical configurations, enabling deployment in spaces where conventional static clips cannot be placed.
Solution Approach 2:
The device employs a nested configuration where compression arms are housed within a delivery catheter, tensioning elements are contained within the compression assembly, and anchoring components are integrated into the overall structure. This nested design allows the entire device to be delivered through small gaps via catheter while providing full functionality once deployed.
3Reliability
If compression force is increased to reduce regurgitation, then valve closure improves, but tissue damage and stenosis occur
Solution Approach 1:
The device uses spring-loaded compression arms that provide controlled compressive force counterbalanced by detachable tensioning elements. The tensioning elements act as counterweights to the compression force, distributing the mechanical load and preventing excessive compression that would cause tissue damage. This counterbalancing mechanism maintains effective valve closure while protecting tissue integrity.
Solution Approach 2:
The device applies compression in a controlled, periodic manner through the spring-loaded arms that can be engaged and disengaged. The detachable tensioning elements allow for periodic adjustment of the compression force, enabling the operator to optimize valve closure while monitoring for signs of tissue stress. This periodic application of force prevents continuous excessive compression that would lead to tissue damage.
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
The device effectively reduces regurgitation by applying compressive forces and tensioning along the line of coaptation, improving valve closure without causing stenosis, and can be deployed in spaces where conventional clips are inappropriate, providing a solution for residual regurgitation issues.
Implementation Method 1
the device is formed from a shape-memory material such that the free ends, when deployed distally, sweep around proximally to grasp targeted cardiac valve tissue
Implementation Method 2
The arms have a default position and are flexibly moveable apart from one another away from the default position to increase the size of the interior space and to enable grasping of cardiac valve tissue within the interior space. The arms are configured to be biased toward the default position when moved apart from one another. In this manner, the arms provide a compressive force upon cardiac valve tissue held within the interior space.
Data Source
AI summary
The present disclosure describes interventional devices, systems, and methods for closing a regurgitant gap in a cardiac valve. Interventional devices are configured to be deployed between two previously placed implants or between a previously placed implant and a valve commissure. The interventional devices compress captured leaflet tissue and/or apply a tensioning force along the line of coaptation to assist in closing the gap and reducing regurgitant flow through the gap.