Cardiac Valve Annulus Remodeling with Directional RF Shrinkage
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Solution Overview
Problem
Existing minimally invasive techniques for treating dysfunctional heart valves, such as mitral valve regurgitation, lack control over the direction and extent of tissue shrinkage, often causing undesired tissue disruption and requiring invasive surgical procedures.
Innovation Solution
A minimally invasive method using an energy delivery catheter with electrodes that can be independently advanced and approximated to apply energy in a controlled manner, allowing for selective tissue shrinkage by grasping and heating the cardiac tissue in the desired direction, optionally combined with chemical agents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical annuloplasty is performed to reduce annular circumference, then valve competency is improved, but surgical trauma and recovery time increase
Solution Approach 1:
The patent replaces the mechanical surgical approach (sewing annulus to annuloplasty ring) with a thermal energy-based approach. RF energy delivered through electrodes heated and shrinks the annular tissue to reduce circumference, eliminating the need for surgical sutures and external annuloplasty rings while achieving the same functional result of improving valve competency
Solution Approach 2:
The patent introduces RF energy as an intermediary between the treatment goal and the tissue. Instead of directly mechanically altering the annulus through surgery, RF energy serves as the medium that transfers thermal energy to the tissue, causing controlled heating and shrinkage of the annular tissue to reduce regurgitation
2Shape
If RF energy is delivered between spaced-apart electrodes to shrink annular tissue, then annular shrinkage is achieved, but control over direction and extent of shrinkage is lost
Solution Approach 1:
The patent divides the annular tissue treatment into multiple discrete electrode pairs positioned at different locations around the annulus. Each electrode pair independently shrinks a specific segment of the annulus, allowing controlled reduction of annular circumference in a stepwise manner while maintaining overall annular geometry and achieving precise directional control
Solution Approach 2:
The patent applies RF energy locally at specific segments of the annulus rather than uniformly across the entire annulus. By positioning electrode pairs at specific locations and delivering energy only to targeted segments, the treatment achieves localized shrinkage in specific directions while preserving the delicate sculpted tissue features of the mitral valve in other areas
3Length of moving object
If existing RF techniques are used to reshape tissue, then tissue shrinkage is achieved, but control over extent of shrinkage is difficult
Solution Approach 1:
The patent employs periodic, stepwise delivery of RF energy through multiple treatment sessions or sequential electrode pair activation. Each electrode pair delivers a controlled amount of energy for a specific duration, allowing incremental shrinkage that can be monitored and adjusted. This periodic approach enables precise control over the total extent of shrinkage by accumulating small, controlled changes rather than attempting large-scale shrinkage in a single step
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
Enables precise and predictable shrinkage of cardiac valve annulus, chordae tendineae, and leaflets, reducing regurgitation and enhancing valve competency without the need for open surgery, using bipolar RF energy, monopolar RF energy, laser, ultrasonic, or microwave energy, and chemical agents like phenol or glutaraldehyde.
Implementation Method 1
applying energy between the at least two electrodes, thereby heating and shrinking the annulus in a direction of the approximating force
Data Source
Figure 1~3
Figure 4A~4C
Figure 4D
AI summary
Devices and minimally invasive methods for reducing the size of a cardiac valve annulus in a beating heart. Embodiments of the methods can include advancing an energy delivery catheter into the heart proximate a cardiac valve annulus, the energy delivery catheter having at least two electrodes. Then advancing the two electrodes such that the two electrodes pierce into the cardiac valve annulus at a distance from one another. The methods further include applying an approximating force to at least one of the two electrodes, thereby reducing the distance between the two electrodes, and applying energy between the at least two electrodes, thereby heating and shrinking the annulus in a direction of the approximating force.