Intravascular Lithotripsy Balloon with Axially Spaced Ring Electrodes

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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 energy waves that travel through the balloon material at subsonic speeds, effectively disrupting calcified regions within blood vessels without causing damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Force

If traditional high pressure balloon angioplasty is used, then the occlusion is cracked open, but the vessel wall suffers damage or dissection due to high stress and strain rate

Engineering Contradiction:
Improveradial forceVSAvoidvessel wall damage
Core Design Contradiction:
ForceVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the traditional mechanical high-pressure balloon expansion system with an electrical discharge system. Electrical arcs are generated between two electrodes disposed within a fluid-filled balloon, creating subsonic pressure waves that propagate through the balloon material to interact with the vessel wall and calcified lesions. This substitution reduces the peak mechanical stress and strain rate applied to the vessel wall while maintaining the therapeutic effect of cracking open the occlusion.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If existing shockwave systems with close electrode spacing are used, then effective lesion treatment is achieved, but the axial coverage is limited

Engineering Contradiction:
Improvelesion treatment effectivenessVSAvoidaxial coverage
Core Design Contradiction:
ReliabilityVSLength of moving object

Solution Approach 1:

The patent employs multiple electrode pairs spaced axially apart from each other along the length of the balloon. Each electrode pair can generate electrical arcs and subsonic pressure waves independently or in combination with adjacent pairs. This segmentation of the treatment zone along the axial dimension enables broader coverage of elongated lesions while maintaining the close spacing within each electrode pair for effective treatment.

Inventive Principle:
Principle #1Segmentation

3Length of moving object

If multiple electrode pairs are spaced apart axially, then broader axial coverage is achieved, but the device complexity increases

Engineering Contradiction:
Improveaxial coverageVSAvoidelectrode pair configuration
Core Design Contradiction:
Length of moving objectVSDevice complexity

Solution Approach 1:

The patent designs the electrode pairs and their carrier as a modular, multi-functional assembly that can serve multiple purposes. The same electrode pair carrier that holds the electrodes can be translated axially to treat different segments of elongated lesions. The fluid-filled balloon serves both as a medium for electrical arc generation and as a pressure wave transmission medium. This multi-functionality reduces the need for separate components and simplifies the overall device structure despite the presence of multiple electrode pairs.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 provides broader axial coverage by generating subsonic pressure waves that effectively crack calcified lesions while minimizing stress on the vessel wall, improving 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

Implementation Method 2

creating a subsonic pressure wave

Methodology Applied
Scientific EffectPressure wave generation: Shock Wave

Data Source

PatentUS11896248B2Systems, devices and methods for generating subsonic pressure waves in intravascular lithotripsy
Publication Date: 2024.02.13 CARDIOVASCULAR SYSTEMS INC
  • US11896248B2 patent drawing
  • US11896248B2 patent drawing
  • US11896248B2 patent drawing

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.