IVL Control System Managing Electrical Arc Pressure
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Solution Overview
Problem
Traditional intravascular lithotripsy systems face challenges in effectively and safely breaking up calcified lesions due to high stress and strain rates, leading to potential damage or dissection of blood vessel walls, and lack refined control over energy delivery, resulting in inconsistent therapy outcomes.
Innovation Solution
The system employs a controlled IVL control system with adjustable energy delivery, incrementally increasing voltage and duration of electrical pulses to generate effective sparks and pressure waves, using spaced-apart electrodes within a fluid-filled member, allowing for precise energy management and reduced risk to the patient.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional balloon angioplasty applies high pressure (10-15 atm) to open occlusions, then the occlusion yields and blood flow improves, but the vessel wall tissue suffers damage or dissection due to high stress and strain rate
Solution Approach 1:
The system applies electrical energy in a series of voltage pulses rather than a single high-pressure event. The controller delivers multiple pulses with controlled duration and magnitude, allowing periodic energy delivery that accumulates therapeutic effect while permitting tissue recovery between pulses, thereby reducing peak stress damage to the vessel wall
Solution Approach 2:
The invention replaces the traditional mechanical balloon inflation system with an electrical energy delivery system. Instead of using mechanical pressure from a balloon to crack calcified lesions, the system uses electrical voltage pulses applied through electrodes to generate thermal and mechanical effects that fragment the calcification, eliminating the need for high mechanical pressure and associated vessel wall damage
2Ease of operation
If coarse system controls are used with simple power supply cessation, then the system is easy to operate, but the energy delivery lacks precision and therapy outcomes are inconsistent
Solution Approach 1:
The system dynamically adjusts multiple electrical parameters including voltage magnitude, pulse duration, and inter-pulse intervals based on real-time feedback and pre-programmed protocols. The controller modifies these parameters during therapy delivery to optimize treatment efficacy while maintaining safety, enabling precise energy delivery without requiring complex manual adjustments by the operator
Solution Approach 2:
The system incorporates feedback mechanisms where the controller monitors delivered energy and tissue response, automatically adjusting subsequent pulse parameters based on measured outcomes. This closed-loop control ensures consistent and precise energy delivery to achieve uniform calcification fracture while preventing overheating or excessive tissue damage
3Strength
If a single high-energy pulse is applied to fracture calcified lesions, then the calcification breaks effectively, but the vessel wall suffers damage from the high stress and strain rate
Solution Approach 1:
The system delivers energy in multiple periodic voltage pulses rather than a single high-energy pulse. Each pulse contributes to calcification fracture through cumulative thermal and mechanical effects, while the intervals between pulses allow heat dissipation and reduce peak stress on the vessel wall, achieving effective calcification removal with minimal tissue damage
Solution Approach 2:
The system applies lower-magnitude preparatory pulses before delivering higher energy pulses. These initial pulses create micro-fractures in the calcification and generate heat that softens the calcified material, reducing the peak stress required for complete fracture and thereby protecting the vessel wall from damage during the main treatment phase
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
This approach enhances the durability and efficiency of the therapy by maintaining consistent pressure output over a longer number of pulses, reducing the risk of vessel damage and improving treatment efficacy while ensuring safety.
Implementation Method 1
applying electrical arc spaced-apart electrodes disposed within a fluid-filled member to creating flow and pressure waves
Implementation Method 2
applying electrical arc spaced-apart electrodes disposed within a fluid-filled member to creating flow and pressure waves
Data Source
AI summary
Various embodiments of the systems, methods, and devices are provided for controlled operation of IVL for breaking up calcified lesions in an anatomical conduit. More specifically, control arrangements are disclosed concerning managing and/or providing electrical energy to generate an electrical arc between a set of spaced-apart electrodes disposed within a fluid-filled balloon, creating stable and constant, or slightly increasing, pressure output over at least 300 voltage pulses. Control arrangements disclosed further determine whether an electrical arc was successfully generated.