Tricuspid Valve Clip With Adjustable Tines for Leaflet Coaptation
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Solution Overview
Problem
Tricuspid valve regurgitation, often caused by structural deformations or defects, leads to blood flow reversal, which is difficult to treat with existing methods, especially in patients with pacemaker leads or during left heart surgeries, and current repair devices face challenges in positioning and effectiveness.
Innovation Solution
An interventional clip device with rotatable distal elements and adjustable proximal elements, delivered via a guide catheter with a support structure, is used to grasp and align tricuspid valve leaflets, allowing for precise repair by deploying clips at optimal positions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If valve replacement procedure is performed, then tricuspid valve regurgitation is treated, but natural valve tissues are removed or rendered inoperable
Solution Approach 1:
The invention extracts only the necessary function of valve replacement (treating regurgitation) while leaving the natural valve tissues intact and functional. The clip device is deployed to approximate leaflets without removing or destroying the natural valve, thus achieving the therapeutic effect while preserving biological tissue.
2Reliability
If valve replacement procedure is performed, then tricuspid valve regurgitation is treated, but patients with pacemaker leads cannot easily or safely undergo the procedure
Solution Approach 1:
The clip device provides a universal treatment approach that can be applied to various patient populations including those with pacemaker leads. By using a percutaneous delivery system that accesses the heart through veins rather than requiring surgical exposure of the valve, the procedure becomes compatible with patients who have pacemaker leads in the vicinity of the valve.
3Reliability
If repair device is deployed, then tricuspid valve regurgitation is treated, but positioning and aligning the device with the valve is difficult
Solution Approach 1:
The invention introduces an intermediary delivery catheter system that facilitates precise positioning of the clip device. The delivery catheter is navigated through the venous system to the right heart, and the clip is deployed from within the catheter at the target site. This intermediary system provides control and stability during positioning, making the procedure easier to perform despite the dynamic cardiac environment.
4Reliability
If clip device is used to grasp valve leaflets, then leaflet coaptation is enhanced, but tissue trauma and entanglement may occur
Solution Approach 1:
The clip device is designed with specific local qualities to minimize tissue trauma while achieving effective grasping. The clip elements have rounded leading edges and smooth surfaces that reduce mechanical damage to the leaflet tissue. The grasping mechanism is designed to distribute force evenly across the tissue surface, preventing concentrated stress points that could cause trauma or entanglement.
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 clip device effectively reduces tricuspid valve regurgitation, improving cardiac output and pulmonary pressure by enhancing leaflet coaptation, with minimal tissue trauma and entanglement.
Implementation Method 1
a pair of proximal elements resiliently biased toward the distal elements
Data Source
AI summary
Devices and methods for use in a cardiac valve repair procedure, particularly a tricuspid valve repair procedure. An interventional clip device includes a pair of distal elements rotatably joined to a coupling member, and a pair of proximal elements resiliently biased toward the distal elements to grasp tissue therebetween. The proximal elements include a plurality of adjustable tines moveable between a retracted configuration and an open configuration to avoid damage to tissue prior to engagement while allowing tines to enhance gripping to targeted tissue when open. A delivery system enables delivery of an interventional clip to a targeted cardiac valve, and includes a support structure for maintaining position relative to the cardiac valve.