Subsonic Pressure Wave Intravascular Lithotripsy Balloon

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Solution Overview

Problem

Traditional balloon angioplasty systems face challenges such as arterial rupture, damage to vessel wall tissue, and limited axial coverage of lesions due to high stress and strain rates, as well as the need for multiple electrode pairs to effectively treat elongated calcified lesions.

Innovation Solution

The system generates subsonic pressure waves using a fluid-filled balloon with axially spaced ring electrodes, creating a spark gap that produces arcs and energy waves traveling at subsonic speeds to disrupt calcified regions within blood vessels, allowing for more controlled and effective treatment of calcified lesions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If traditional high pressure balloon angioplasty is used to treat calcified lesions, then the occlusion yields and blood flow improves, but the vessel wall tissue suffers damage or dissection due to high stress and strain rate

Engineering Contradiction:

Improveocclusion yield and blood flow improvementVSAvoidvessel wall damage and dissection

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the fundamental parameter of pressure wave propagation speed from supersonic (traditional lithotripsy) to subsonic. This parameter change allows the pressure wave to deliver therapeutic effect to calcified lesions while reducing peak stress and strain rate on the vessel wall, thereby preventing tissue damage and dissection

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The system employs periodic electrical pulses to generate repeated subsonic pressure waves through the balloon wall. This periodic action allows controlled delivery of mechanical energy to disrupt calcified material over time while maintaining safety through repeated low-intensity cycles rather than a single high-intensity event

Inventive Principle:

Principle #19Periodic action

2Area of stationary object

If multiple electrode pairs are spaced apart axially to cover elongated lesions in traditional systems, then axial coverage improves, but device complexity increases

Engineering Contradiction:

Improveaxial coverage of lesionsVSAvoidnumber of electrode pairs and translatable components

Core Design Contradiction:

Area of stationary objectVSDevice complexity

Solution Approach 1:

The patent divides the treatment function into multiple axially-spaced electrode pairs within the balloon, where each pair can be independently controlled. This segmentation allows coverage of elongated lesions through selective activation of different electrode pairs along the axial direction, providing flexible treatment zones without requiring mechanical translation

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The system enables dynamic selection and independent control of multiple electrode pairs along the axial direction. By dynamically activating specific electrode pairs based on lesion location and extent, the system achieves adaptable axial coverage without mechanical movement or complex positioning mechanisms

Inventive Principle:

Principle #15Dynamics

3Strength

If supersonic shock waves are generated in traditional intravascular lithotripsy, then calcified material is disrupted effectively, but the risk of arterial rupture and vessel wall damage increases

Engineering Contradiction:

Improvecalcified material disruptionVSAvoidarterial rupture and vessel wall damage

Core Design Contradiction:

StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent fundamentally changes the pressure wave propagation speed parameter from supersonic to subsonic range. This parameter change maintains the ability to disrupt calcified material through mechanical pressure while reducing the harmful effects associated with supersonic shock waves, such as arterial rupture and vessel wall damage

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The invention converts the potentially harmful supersonic shock wave into a beneficial subsonic pressure wave. By changing the propagation speed regime, the system retains the therapeutic benefit of calcified material disruption while eliminating the harmful effects of excessive peak pressures and vessel wall damage

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

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 reduces the risk of vessel damage and improves axial coverage by generating subsonic pressure waves that effectively disrupt calcified and non-calcified occluding material, enhancing the safety and efficacy of the angioplasty procedure.

Implementation Method 1

an electrical arc is generated between two electrodes disposed within a fluid-filled balloon, creating a subsonic pressure wave

Methodology Applied

Scientific EffectElectrical arc: Electric Arc

Data Source

PatentUS20230044926A1Methods, systems and devices for generating subsonic pressure waves in intravascular lithotripsy

Publication Date: 2023.02.09 CARDIOVASCULAR SYSTEMS INC

AI summary

Various embodiments of the systems, methods and devices are provided for breaking up calcified lesions in an anatomical conduit. More specifically, an electrical arc is generated between two spaced-apart electrodes disposed within a fluid-filled balloon, creating a subsonic pressure wave. In some embodiments, the electrodes comprise a plurality of points that allow the electrical arc to form at any one of the plurality of points to, among other things, extend the electrode life.