Lithoplasty Balloon Spark Gap for Subsonic Pressure Wave Generation

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Solution Overview

Problem

Traditional balloon angioplasty systems face challenges such as arterial rupture, vessel wall damage, and limited axial coverage due to high stress and strain rates, especially when dealing with calcified lesions, and existing shockwave systems require close electrode spacing for effective treatment.

Innovation Solution

The use of subsonic pressure wave generators within a fluid-filled balloon, comprising proximal and distal ring electrodes with spark gaps, generates energy waves that travel at subsonic speeds through the balloon material to interact with tissue and calcified material, providing broader axial coverage and reducing the risk of vessel damage.

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 suffers damage including arterial rupture and dissection due to high stress and strain rates

Engineering Contradiction:

Improveblood flow improvementVSAvoidvessel wall damage

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The invention changes the fundamental parameter of wave propagation speed from supersonic to subsonic. By controlling the electrode spacing and electrical pulse parameters, the system generates pressure waves that travel through the balloon wall at subsonic speeds, fundamentally altering the interaction mechanism with calcified lesions to reduce vessel wall damage while maintaining treatment efficacy

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The system dynamically adjusts electrode spacing and electrical pulse parameters to control pressure wave generation. The electrode spacing is specifically designed to create subsonic pressure waves, and the electrical pulses are timed and sized to optimize the dynamic interaction with calcified lesions while minimizing harmful effects on the vessel wall

Inventive Principle:

Principle #15Dynamics

2Reliability

If shockwave systems with close electrode spacing are used to generate pressure waves, then treatment effectiveness improves, but axial coverage is limited requiring multiple electrode pairs or translatable carriers

Engineering Contradiction:

Improvetreatment effectivenessVSAvoidaxial coverage

Core Design Contradiction:

ReliabilityVSLength of moving object

Solution Approach 1:

The invention transitions from a single electrode pair to multiple electrode pairs arranged axially along the balloon. This dimensional expansion allows simultaneous generation of multiple subsonic pressure waves at different axial positions, dramatically extending the axial coverage from millimeters to centimeters while maintaining treatment effectiveness through the subsonic wave mechanism

Inventive Principle:

Principle #17Another dimension (Dimensionality change)

3Strength

If supersonic shock waves are generated to disrupt calcified material, then lesion disruption is effective, but the risk of arterial rupture and vessel dissection increases

Engineering Contradiction:

Improvelesion disruption capabilityVSAvoidarterial rupture risk

Core Design Contradiction:

StrengthVSObject-affected harmful factors

Solution Approach 1:

The invention fundamentally changes the wave speed parameter from supersonic to subsonic. This parameter change alters the physical interaction mechanism with calcified lesions, providing sufficient disruption capability through repeated subsonic cycling while eliminating the catastrophic vessel wall damage associated with supersonic shock waves

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The system employs periodic electrical pulses to generate repeated subsonic pressure waves. This periodic action allows cumulative disruption of calcified material through multiple cycles of pressure application and release, achieving effective lesion treatment while maintaining vessel wall integrity through the gentler subsonic mechanism

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 effectively disrupts calcified regions within blood vessels while minimizing damage to the vessel wall, offering improved treatment efficacy and safety by using subsonic waves that travel through the balloon material at slower speeds, thus reducing the risk of arterial rupture and dissection.

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

Implementation Method 2

creating a subsonic pressure wave

Methodology Applied

Scientific EffectPressure wave generation: Shock Wave

Data Source

PatentUS11801066B2Systems, devices and methods for selection of arc location within a lithoplasty balloon spark gap

Publication Date: 2023.10.31 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.