Fluid-Filled Balloon Electrode 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 lesion treatment.

Innovation Solution

The system generates subsonic pressure waves using a fluid-filled balloon with axially spaced ring electrodes, creating a spark gap to produce arcs that travel at subsonic speeds, effectively disrupting calcified regions within blood vessels while minimizing tissue damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

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

Engineering Contradiction:

Improveocclusion yieldVSAvoidvessel wall damage

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the traditional mechanical high-pressure balloon expansion system with an electrical discharge system. Electrodes generate electrical arcs that create plasma channels and pressure waves to fracture calcified lesions, substituting mechanical force with electrical and plasma-based mechanisms to achieve lesion disruption without excessive mechanical stress on the vessel wall

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent changes the physical parameters of energy delivery by using controlled electrical discharge parameters (voltage, current, pulse duration) instead of mechanical pressure parameters. The system controls the energy delivery to fracture calcification while maintaining vessel wall integrity through precise parameter management

Inventive Principle:

Principle #35Parameter changes

2Reliability

If close electrode spacing is used in shockwave systems to generate effective pressure waves, then lesion treatment effectiveness improves, but the axial coverage is limited

Engineering Contradiction:

Improvelesion treatment effectivenessVSAvoidaxial coverage

Core Design Contradiction:

ReliabilityVSLength of moving object

Solution Approach 1:

The patent divides the treatment system into multiple electrode pairs spaced axially along the balloon. Each electrode pair acts as an independent treatment zone, allowing the system to cover extended axial lengths while maintaining effective treatment at each segment. The balloon is inflated to contact the vessel wall along a sufficient axial distance to treat the entire lesion

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent transitions from a single-point or limited-zone treatment approach to a distributed multi-zone treatment system. By spacing multiple electrode pairs axially along the balloon circumference, the system expands treatment coverage from a single location to multiple axial positions, effectively increasing the treated length

Inventive Principle:

Principle #17Another dimension (Dimensionality change)

3Reliability

If supersonic shock waves are generated to disrupt calcified lesions, then lesion fracture effectiveness improves, but the risk of tissue damage and arterial rupture increases

Engineering Contradiction:

Improvelesion fracture effectivenessVSAvoidtissue damage

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the wave velocity parameter from supersonic to subsonic by controlling the electrical discharge characteristics and balloon inflation parameters. This parameter change allows effective lesion disruption through controlled pressure wave generation while reducing the harmful effects associated with supersonic shock waves, such as excessive tissue damage and arterial rupture risk

Inventive Principle:

Principle #35Parameter changes

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 allows for more controlled and efficient disruption of calcified lesions with reduced risk of vessel damage, providing broader axial coverage and safer treatment by using subsonic waves that travel through the balloon material at slower speeds, impacting tissue at subsonic velocities.

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

PatentUS11877761B2Systems, devices and methods for monitoring voltage and current and controlling voltage of voltage pulse generators

Publication Date: 2024.01.23 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.