Folding Valve Leaflet Gripper for Atraumatic Coaptation
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Solution Overview
Problem
Mitral and tricuspid valve regurgitation (MVR and TVR) occur due to improper closure of valve leaflets, leading to severe health consequences, and existing treatments like Guideline-Directed Medical Therapy, valve replacement, and catheter-based repairs face limitations.
Innovation Solution
A fixation device with distal and proximal elements, featuring a hinge mechanism and frictional elements, is used to percutaneously grasp and hold valve leaflets in a coapted position, mimicking a surgical bow-tie repair, reducing regurgitation through a minimally invasive procedure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a fixation device with gripping elements is used to grasp valve leaflets, then the valve regurgitation is reduced by maintaining leaflet coaptation, but the frictional elements may cause tissue trauma or injury
Solution Approach 1:
The patent employs a flexible covering that envelops the frictional elements of the gripping device. This covering is made of soft, compliant material that allows the device to maintain grip on valve leaflets while preventing direct contact between the frictional elements and the tissue, thereby reducing tissue trauma while maintaining fixation reliability
Solution Approach 2:
The covering acts as an intermediary layer between the frictional elements and the valve leaflets. It transmits the gripping force necessary to maintain coaptation while simultaneously protecting the tissue from direct mechanical injury by the rigid frictional elements
2Strength
If the frictional elements are made prominent to enhance gripping capability, then the leaflet coaptation is improved, but the risk of snagging on chordae tendineae or papillary muscles increases
Solution Approach 1:
The flexible covering extends over the frictional elements, allowing them to maintain sufficient prominence for gripping while the soft material prevents them from snagging on delicate structures like chordae tendineae and papillary muscles by allowing smooth passage and reducing mechanical interference
3Ease of operation
If a minimally invasive percutaneous procedure is used for valve repair, then the patient recovery is improved, but the precision and control of the repair procedure is reduced compared to surgical approaches
Solution Approach 1:
The gripping device incorporates dynamic elements including a movable proximal element that can be adjusted between engaged and disengaged positions, and a hinge mechanism that allows the distal element to pivot. These dynamic features enable precise control and adjustment of the gripping force and angle, allowing the operator to achieve accurate leaflet coaptation while maintaining a minimally invasive percutaneous approach
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 valve regurgitation by maintaining leaflet coaptation, providing a durable and minimally invasive solution for MVR and TVR, with adjustable tension and atraumatic engagement to minimize tissue trauma.
Implementation Method 1
The gripping device may include a base section, a first bend feature defining a first hinge axis, and a first proximal element extending from the first bend feature
Implementation Method 2
The second section may have a plurality of frictional elements that may extend therefrom and may be rotatable about the second hinge axis
Data Source
AI summary
A fixation device includes a first distal element and a gripping device. The gripping device including a base section, a first bend feature, and a first proximal element. The first bend feature defining a first hinge axis. The first proximal element extending from the first bend feature and having a first section, a second section, and a first hinge disposed between the first section and the second section and defining a second hinge axis. The second section having a plurality of frictional elements extending therefrom and being rotatable about the second hinge axis between a first configuration and a second configuration.