Tricuspid Valve Plug With Prosthetic Valve for Regurgitation Treatment
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Solution Overview
Problem
Current treatments for tricuspid regurgitation, such as open-heart surgery and minimally invasive techniques, pose risks and procedural complexities, and often result in recurring regurgitation or tricuspid stenosis, limiting effective management for high-risk patients.
Innovation Solution
A compressible and expandable plug device with a prosthetic valve is implanted at the native tricuspid valve orifice, acting as a plug during systole to prevent regurgitation and allowing full blood flow during diastole, utilizing a stent with a lattice structure and anchoring mechanism for secure placement without requiring open-heart surgery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a tricuspid plug is placed in the valve leakage gap to block regurgitation, then regurgitation is reduced, but the effective orifice area of the tricuspid valve is significantly reduced during diastole, resulting in elevation of venous pressure and reduction of right ventricular function
Solution Approach 1:
The prosthetic valve is nested inside the plug device, with the valve positioned within the plug's structure. This allows the plug to block regurgitation during systole while the nested valve opens during diastole to maintain adequate forward blood flow through the orifice, preventing tricuspid stenosis.
Solution Approach 2:
The device incorporates a dynamic prosthetic valve that can open and close in response to pressure changes during the cardiac cycle. During diastole, the valve opens to allow full blood flow through the orifice; during systole, the plug closes to prevent regurgitation. This dynamic behavior resolves the contradiction between blocking regurgitation and maintaining forward flow.
2Reliability
If open-heart surgery such as valve annuloplasty is performed to treat tricuspid regurgitation, then regurgitation can be corrected, but the procedure involves high risk and mortality especially for high-risk patients
Solution Approach 1:
The invention replaces the mechanical open-heart surgical system with a transcatheter-based delivery system. The plug device with integrated prosthetic valve is delivered through a catheter inserted via the jugular vein, eliminating the need for sternotomy and cardiopulmonary bypass, thereby significantly reducing surgical risk and mortality for high-risk patients.
Solution Approach 2:
The catheter serves as an intermediary delivery mechanism, allowing the plug device to be implanted percutaneously rather than requiring open surgical access. This intermediary approach enables treatment of high-risk patients who would otherwise be ineligible for surgical intervention.
3Object-affected harmful factors
If minimally invasive techniques such as transcatheter valve annuloplasty are used to treat tricuspid regurgitation, then surgical risk is reduced, but the procedures involve significant procedural difficulties and results vary
Solution Approach 1:
The invention merges the plug device and prosthetic valve into a single integrated unit. This combination simplifies the implantation procedure compared to separate annuloplasty rings or valves, as the integrated device can be deployed in one action while providing both regurgitation prevention and forward flow capability.
Solution Approach 2:
The plug device serves multiple functions: it acts as an annuloplasty ring to reshape the valve, provides a scaffold for the prosthetic valve, and directly blocks regurgitation. This multi-functionality reduces procedural complexity by consolidating multiple surgical steps into a single device implantation.
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 treats tricuspid regurgitation by blocking leakage during systole while maintaining blood flow during diastole, reducing the risk of tricuspid stenosis and being suitable for minimally invasive procedures, including high-risk patients, with the option for retrieval if placement is suboptimal.
Implementation Method 1
The stent has a shape of one or combination of a tubular shape, a conical shape or a spherical shape
Implementation Method 2
a compressible and expandable valve-in-plug
Data Source
AI summary
A device for treating regurgitation of a tricuspid valve (4) is disclosed. The device comprises a tricuspid valve plug (21) capable of compressing and expanding and a tricuspid valve plug fixing device used for anchoring the tricuspid valve-in-plug (21) to an orifice of the tricuspid valve (4). The tricuspid valve plug (21) is provided with an inflow end (42, 52) and an opposite outflow end (47, 57), and a prosthetic valve (50, 70) capable of being opened and closed is disposed in the tricuspid valve plug (21). When the tricuspid valve (4) is dosed, the prosthetic valve (50, 70) is automatically closed, and when the tricuspid valve (4) is opened, the prosthetic valve (50, 70) is automatically opened.