Two-Valve Caval Stent for Tricuspid Regurgitation

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Solution Overview

Problem

Current treatments for incompetent tricuspid valve regurgitation lack effective minimally invasive solutions, with concerns over device fixation, embolization, and myocardial trauma in existing stent valve devices.

Innovation Solution

A two-valve caval stent system with self-expanding vascular stents and adjustable bridge connecting struts, featuring cone-shaped valves with three cusps to simulate native tricuspid valve function, allowing precise positioning and fixation in the superior and inferior vena cavae to prevent retrograde blood flow.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a stent valve device is implanted to replace the tricuspid valve, then tricuspid regurgitation is treated, but device fixation and embolization risks increase

Engineering Contradiction:
Improvetricuspid regurgitation treatmentVSAvoiddevice fixation and embolization risks
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device is divided into two separate stents (superior vena cava stent and inferior vena cava stent) connected by a bridge structure. This segmentation allows each stent to be independently positioned and secured in its respective vein, distributing the fixation burden and reducing the risk of simultaneous embolization. The bridge connects the two stents to maintain proper spacing and functional relationship while allowing independent stabilization of each component.

Inventive Principle:
Principle #1Segmentation

2Reliability

If existing stent valve devices are used for tricuspid valve replacement, then valve function is restored, but myocardial trauma risk increases

Engineering Contradiction:
Improvevalve function restorationVSAvoidmyocardial trauma risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention extracts the valve function from the traditional single-structure stent valve and relocates it to a dual-stent configuration with a bridge. This extraction allows the device to achieve valve replacement function while avoiding direct contact with and trauma to the myocardium, as the two stents are positioned in the vena cavae rather than requiring direct myocardial interaction for stabilization.

Inventive Principle:
Principle #2Taking out (Extraction)

3Stability of the object's composition

If a fixed-structure stent valve is implanted, then device stability is achieved, but adaptability to patient anatomy is reduced

Engineering Contradiction:
Improvedevice stabilityVSAvoidanatomical adaptability
Core Design Contradiction:
Stability of the object's compositionVSAdaptability or versatility

Solution Approach 1:

The bridge connecting the two stents is designed to be adjustable in length, transforming the device from a fixed-structure to a dynamic, adaptable configuration. This allows the distance between the superior and inferior vena cava stents to be customized according to individual patient anatomy while maintaining stable fixation of each stent in its respective vein. The adjustability is achieved through mechanisms such as telescoping sections or adjustable connection elements.

Inventive Principle:
Principle #15Dynamics

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 system effectively prevents tricuspid regurgitation by blocking retrograde blood flow into the right atrium, demonstrating functional replacement of the tricuspid valve with stable positioning and patency, as shown in animal studies, reducing symptoms of congestive heart failure.

Implementation Method 1

the stents may be formed of a shape memory alloy and have a wire braided construction that permits self-expansion when deployed inside the superior and inferior caval veins

Methodology Applied
Scientific EffectShape memory alloy: Shape Memory Alloy

Data Source

PatentEP2600798B1Two valve caval stent for functional replacement of incompetent tricuspid valve
Publication Date: 2015.10.28 COOK MEDICAL TECHNOLOGIES LLC
  • EP2600798B1 patent drawingFigure 1A~1B
  • EP2600798B1 patent drawingFigure 2A~2B
  • EP2600798B1 patent drawingFigure 3A~3F

AI summary

A two valve caval stent for functional replacement of an incompetent tricuspid valve. The device is designed for minimally invasive percutaneous transcatheter placement and includes two stents connected by a bridge sized to span the right atrium, and two valves anchored by the stents in the superior and inferior vena cavas. Each of the valves optionally has a conical shape divided by supporting struts into three cusps that simulate the action of a native tricuspid valve.