IVL Energy Pulse Control for Calcified Lesion Disruption

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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.

Innovation Solution

The system employs a control mechanism with a processor and circuitry to adjust energy delivery to electrodes within a fluid-filled member, incrementally increasing voltage and duration to generate effective sparks and pressure waves while monitoring parameters, ensuring efficient and safe energy application.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If high pressure is applied to break calcified lesions, then treatment efficacy is improved, but risk of vessel wall damage increases

Engineering Contradiction:

Improvetreatment efficacyVSAvoidvessel wall damage

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system applies electrical energy in periodic pulsed sequences rather than continuous delivery. The controller delivers multiple voltage pulses with controlled intervals, allowing tissue response time between pulses. This periodic action enables effective calcified lesion disruption while providing natural stress relief periods that prevent cumulative damage to vessel walls.

Inventive Principle:

Principle #19Periodic action

Solution Approach 2:

The system dynamically adjusts voltage magnitude, pulse duration, and inter-pulse intervals based on real-time monitoring of electrical parameters and tissue response. The controller modifies delivery parameters mid-procedure to optimize therapeutic effect while preventing excessive stress accumulation, transitioning from static to adaptive energy delivery.

Inventive Principle:

Principle #15Dynamics

2Productivity

If voltage pulse magnitude is increased to improve calcified lesion disruption, then treatment effectiveness is improved, but risk of over-inflation and tissue damage increases

Engineering Contradiction:

Improvecalcified lesion disruption efficiencyVSAvoidtissue damage from over-inflation

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The system continuously monitors electrical parameters including impedance, current draw, and voltage delivery during each pulse sequence. The controller uses this feedback information to detect tissue response and adjust subsequent pulse magnitude and duration, preventing excessive energy delivery that could cause vessel wall damage while maintaining effective disruption of calcified lesions.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The system dynamically changes multiple parameters including voltage magnitude, pulse width, inter-pulse interval, and total pulse number based on tissue response. Rather than using fixed high-amplitude pulses, the controller adapts parameter combinations to achieve effective calcified lesion disruption at lower peak stresses, reducing risk of vessel wall damage.

Inventive Principle:

Principle #35Parameter changes

3Device complexity

If coarse system controls are used with simple on/off power supply, then device complexity is reduced, but therapy precision and consistency deteriorate

Engineering Contradiction:

Improvecontrol system simplicityVSAvoidtherapy delivery precision

Core Design Contradiction:

Device complexityVSManufacturing precision

Solution Approach 1:

The control system transitions from static on/off switching to dynamic multi-parameter control. The controller adjusts voltage magnitude, pulse duration, and inter-pulse intervals in real-time based on tissue response, enabling precise therapy delivery. This dynamic control achieves consistent therapeutic outcomes while maintaining reasonable device complexity through integrated control algorithms.

Inventive Principle:

Principle #15Dynamics

4Productivity

If high stress and strain rate are applied to occlusion, then calcified lesion removal is improved, but conduit damage or dissection occurs

Engineering Contradiction:

Improvecalcified lesion removal efficiencyVSAvoidconduit damage

Core Design Contradiction:

ProductivityVSObject-generated harmful factors

Solution Approach 1:

The system applies electrical stress in periodic pulses with controlled duty cycles rather than continuous high-stress delivery. The intermittent nature of pulsed energy delivery allows stress relaxation between pulses, preventing cumulative damage to the conduit while maintaining effective disruption of calcified lesions during active pulse periods.

Inventive Principle:

Principle #19Periodic action

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 consistency of therapy, maintaining higher pressure output over a longer number of pulses, reducing the risk of vessel damage and improving treatment efficacy.

Implementation Method 1

applying electrical arc spaced-apart electrodes disposed within a fluid-filled member to creating flow and pressure waves

Methodology Applied

Scientific EffectElectrical arc: Electric Arc

Data Source

PatentUS20240156477A1Control of IVL systems, devices and methods thereof

Publication Date: 2024.05.16 CARDIOVASCULAR SYSTEMS INC

AI summary

Various embodiments of the systems, methods, and devices are provided for controlled operation of an intravascular lithotripsy system 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 fluid-fillable member are disclosed.