Delayed-Release Annuloplasty Ring for Tricuspid Annulus Reshaping
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Solution Overview
Problem
Existing treatments for heart valve disease, such as transcatheter valve replacement and annuloplasty, face challenges with the tricuspid valve due to its large annulus size and potential for blood clotting and inadequate remodeling, while percutaneous annuloplasty procedures are complex and time-consuming with mixed clinical success.
Innovation Solution
An annuloplasty ring system with a shape-memory frame and biodegradable connectors that maintains an initial larger diameter until secured by tissue ingrowth, gradually reducing the tricuspid valve annulus diameter over time, avoiding the need for prosthetic valves and invasive surgery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a transcatheter replacement valve is implanted in a large dilated annulus, then the tricuspid valve regurgitation is treated, but the risk of blood clotting increases and foreign material accumulates in low-flow areas
Solution Approach 1:
The annuloplasty ring is deployed preliminarily to reshape and reduce the size of the dilated annulus before the prosthetic valve is implanted. This preliminary action creates a smaller, more appropriate annular dimension that reduces low-flow areas and minimizes the risk of blood clotting and thrombosis while still allowing effective treatment of tricuspid valve regurgitation.
2Shape
If a rigid annuloplasty ring is sutured during open heart surgery, then the annulus is forced to resize and reshape, but the procedure becomes highly invasive
Solution Approach 1:
The patent replaces the mechanical suture fixation system used in open heart surgery with a self-expanding elastic memory alloy structure. The annuloplasty ring is delivered catheter-based and expands automatically upon deployment, using the elastic memory effect of the alloy to achieve annulus reshaping without the need for open surgery, sutures, or clamps, thereby significantly reducing surgical invasiveness.
3Ease of manufacture
If a percutaneous annuloplasty ring is attempted, then invasive surgery is avoided, but the procedure becomes highly complex and time-consuming with mixed clinical success
Solution Approach 1:
The patent employs an elastic memory alloy structure that functions as a flexible self-expanding shell. This single-piece flexible structure simplifies the device design and deployment mechanism, allowing the annuloplasty ring to be delivered through a catheter and expand automatically upon release, thereby reducing procedural complexity and improving clinical success rates while maintaining percutaneous access benefits.
4Reliability
If a prosthetic heart valve is implanted, then tricuspid valve regurgitation is treated, but the frame inhibits desirable remodeling of the right ventricle
Solution Approach 1:
The patent segments the treatment approach into two distinct components: first, the annuloplasty ring that reshapes the annulus to treat regurgitation, and second, the prosthetic valve that provides valve function. By treating the annulus separately before valve implantation, the patent allows the right ventricle to remodel more naturally around the prosthetic valve, improving ventricular-annular geometry and reducing the inhibitory effect on desirable remodeling.
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 annuloplasty ring effectively reduces tricuspid valve regurgitation by reshaping the annulus after secure implantation, minimizing blood clotting risks and promoting natural heart remodeling without invasive surgery.
Implementation Method 1
The frame may be formed of a shape-memory material and may be shape-set to a final condition in which the frame has a final diameter
Implementation Method 2
The plurality of biodegradable connectors may maintain the frame in an initial condition having an initial diameter, the initial diameter being larger than the final diameter
Data Source
Figure 1
Figure 2A~2B
Figure 2C~2D
AI summary
An annuloplasty ring system may include an annuloplasty ring (100a). The annuloplasty ring may include a frame (120a) having a plurality of cells, the plurality of cells forming a circumferential ring. The annuloplasty ring may also include a skirt (160a) coupled to a bottom surface of the frame, and a plurality of biodegradable connectors (140a), each of the plurality of biodegradable connectors connecting two portions of a corresponding one of the plurality of cells. The frame may be formed of a shape-memory material and may be shape-set to a final condition in which the frame has a final diameter (Db). The plurality of biodegradable connectors may maintain the frame in an initial condition having an initial diameter (Da), the initial diameter being larger than the final diameter.