Self-Expandable Tricuspid Valve Frame Design
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Solution Overview
Problem
Current treatments for tricuspid valve regurgitation, such as the TriAlign system and MitraClip, are either repair systems not designed for replacement or are not FDA approved for tricuspid valve use, posing safety and efficacy issues, especially for patients ineligible for open-heart surgery.
Innovation Solution
A self-expandable tricuspid valve apparatus with a frame and neo-prosthetic valve designed for transcatheter placement, featuring a strutted atrial dome and ventricular struts that conform to the heart's anatomy without obstructing blood flow, allowing for the restoration of right-sided heart function and reversal of pathophysiology associated with severe tricuspid regurgitation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open-heart valve surgery is performed, then valve replacement effectiveness is achieved, but perioperative mortality and post-operative complications increase
Solution Approach 1:
The patent replaces the mechanical open-heart surgical system with a transcatheter delivery system. The self-expandable frame is delivered through a catheter and deployed within the heart, eliminating the need for sternotomy and cardiopulmonary bypass. This substitution of delivery mechanism directly reduces perioperative mortality and post-operative complications while maintaining valve replacement effectiveness.
Solution Approach 2:
The patent employs a self-expandable frame constructed from flexible materials that can be compressed into a catheter for delivery and then automatically expand to their predetermined shape upon deployment. This flexibility enables minimally invasive transcatheter delivery while ensuring proper anatomical conforming and secure positioning of the valve prosthesis, thereby reducing surgical trauma and complications.
2Shape
If TriAlign repair system is used, then annulus morphology is improved, but valve replacement function is not achieved
Solution Approach 1:
The patent combines the annuloplasty function (shaping the annulus) with the valve replacement function into a single integrated device. The self-expandable frame includes an annuloplasty portion that reshapes the annulus and a valve support portion that holds the valve prosthesis, merging two separate functions into one device that simultaneously achieves both annular remodeling and valve replacement.
Solution Approach 2:
The self-expandable frame serves multiple functions: it provides annuloplasty by reshaping the annulus, supports the valve prosthesis in proper positioning, and anchors the entire assembly securely within the heart. This multi-functionality allows a single device to accomplish what previously required separate repair and replacement procedures.
3Ease of operation
If MitraClip is used for tricuspid valve, then repair capability is provided, but FDA approval and safety for tricuspid use are not established
Solution Approach 1:
The patent introduces a dedicated tricuspid valve replacement system that serves as an intermediary solution specifically designed for the tricuspid valve anatomy. Rather than adapting mitral valve devices, this system is purpose-built with appropriate sizing, geometry, and delivery mechanisms for tricuspid application, establishing proper safety and efficacy through dedicated design and FDA approval.
Solution Approach 2:
The patent applies local quality by designing the frame and valve prosthesis with specific geometric characteristics matched to tricuspid valve anatomy. The frame geometry, strutting pattern, and valve size are optimized for the tricuspid valve's unique anatomical features, ensuring proper function and safety specific to this valve location rather than using generic or mitral-specific designs.
4Ease of operation
If self-expandable frame is deployed, then transcatheter placement is achieved, but frame stability and anchoring must be ensured
Solution Approach 1:
The patent segments the frame into multiple functional portions: an annuloplasty portion for reshaping the annulus, a valve support portion for holding the prosthesis, and anchoring elements for securing the device. This segmentation allows each portion to perform its specific function while collectively providing stable anchoring through distributed engagement with the cardiac anatomy.
Solution Approach 2:
The patent employs curved and contoured frame elements that conform to the natural curvature of the cardiac anatomy. The frame's geometry is designed to match the spherical or ellipsoidal shape of the annulus and ventricular surface, enhancing anchoring stability through geometric interlocking and distributed contact forces rather than relying solely on mechanical locking mechanisms.
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 solution provides a less invasive, safer option for tricuspid valve replacement, improving patient symptoms and potentially extending life expectancy, suitable for patients with advanced right heart disease or contraindications for open-heart surgery.
Implementation Method 1
The frame and valve assembly is collapsible so that prior to deployment, the assembly is placed in a vascular catheter, and then self-expands upon release in the heart (cardiac chambers)
Data Source
AI summary
A tricuspid valve apparatus may include a frame and an associated neo-prosthetic valve. The frame acts as a stabilizing structure that extends cephalad into the morphologic or functional right atrium (upstream) and caudally into the morphologic or functional right ventricle (downstream). The frame comprises a strutted atrial dome that conforms to the atrium without obstruction of blood flow from the incoming great veins (i.e. superior vena cava and inferior vena cava) or other anomalous veins and/or tributaries. The frame further comprises ventricular struts to be placed within the right ventricle to secure the neo-prosthetic valve in a desired position. The assembly of the frame and valve is collapsible so that prior to deployment the assembly is placed in a vascular catheter, and then self-expands upon release in the heart.