Valve Leaflet Fixation Structure for Protected Coaptation
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Solution Overview
Problem
Mitral and tricuspid valve regurgitation (MVR and TVR) lead to severe health consequences due to the failure of valve leaflets to properly seal during systole, causing regurgitative flow into the atrium, and existing treatments like Guideline-Directed Medical Therapy, valve replacement, and catheter-based repair have limitations.
Innovation Solution
A fixation device with distal and proximal elements, featuring elongate arms, guard rails, 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 interventional means.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If catheter-based repair procedures (TEER) are used to treat MVR and TVR, then the invasiveness of treatment is reduced, but the ability to properly secure and maintain valve leaflet coaptation is compromised
Solution Approach 1:
The fixation device is divided into multiple independent elements including proximal elements with elongate arms, distal elements, guard rails, and frictional elements. Each segment performs a specific function: proximal elements grasp the valve leaflet, distal elements provide counter-grasp, guard rails protect tissue, and frictional elements maintain secure holding. This segmentation allows the device to be delivered catheter-based while reliably securing leaflet coaptation through coordinated action of multiple specialized components.
Solution Approach 2:
Different portions of the fixation device have specialized local characteristics optimized for specific functions. The proximal elements feature frictional elements with specific surface properties for grasping leaflet tissue, while distal elements have complementary grasping surfaces. Guard rails have specific geometric profiles for tissue protection. This local quality differentiation enables reliable coaptation maintenance through catheter-based delivery, as each local feature contributes to overall device effectiveness without requiring open surgical exposure.
2Force
If frictional elements are added to the proximal elements, then the grasping capability on valve leaflets is improved, but the risk of tissue damage from excessive friction increases
Solution Approach 1:
The proximal elements incorporate frictional elements with specific local surface characteristics that provide enhanced grasping force while controlling tissue interaction. These frictional elements have localized high-friction zones for secure holding combined with protective geometric features that limit contact pressure and distribution. This local quality optimization allows the device to exert sufficient grasping force for reliable leaflet coaptation while minimizing the risk of tissue damage through controlled friction distribution.
Solution Approach 2:
The proximal elements are designed with frictional elements that incorporate tissue protection features before tissue contact occurs. The geometric configuration of these elements includes rounded surfaces, controlled contact areas, and friction-modulating structures that prevent excessive localized stress. This beforehand cushioning approach ensures that when the device grasps the valve leaflet, the frictional force is distributed in a way that secures the leaflet without causing damage, resolving the contradiction between grasping capability and tissue safety.
3Object-affected harmful factors
If guard rails are incorporated to protect tissue, then the safety of the procedure is improved, but the device complexity increases
Solution Approach 1:
The guard rails are merged with the proximal and distal elements to form an integrated fixation device structure. Rather than being separate components, the guard rails are incorporated as integral features of the elongate arms and grasping elements, protecting tissue while maintaining structural efficiency. This merging approach provides comprehensive tissue protection through coordinated action of multiple integrated components, achieving safety goals without proportionally increasing overall device complexity.
Solution Approach 2:
The proximal and distal elements serve multiple functions simultaneously: they provide tissue grasping, maintain coaptation positioning, and protect surrounding tissue through integrated guard rail features. This multi-functionality reduces the need for separate dedicated protection components, as the primary structural elements are designed to perform both grasping and protective functions. The guard rails are thus incorporated into the essential grasping structure rather than added as separate complexity-increasing components.
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 leaflets in a coapted state, improving hemodynamic function and providing a minimally invasive treatment option for MVR and TVR.
Implementation Method 1
a first proximal element moveable relative to the first distal element, the first proximal element having a first elongate arm with a plurality of frictional elements
Data Source
AI summary
A fixation device includes first and second distal elements and first and second proximal elements. The first and second proximal elements include a first elongate arm and a second elongate arm, respectively. The first and second elongate arms each include first and second side edges and plurality of frictional elements defining a plurality notches in the first and second side edges. The first and second proximal elements also each include first and second guard rails extending adjacent to and along the first and second side edges, respectively.