Intravascular Lithotripsy Balloon with Electrical Arc Electrodes

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Solution Overview

Problem

Traditional balloon angioplasty systems face challenges such as arterial rupture, damage to vessel walls, and limited axial coverage due to high stress and strain rates, as well as the need for multiple electrode pairs to treat elongated lesions, which can lead to complications like hematoma and pseudoaneurysm formation.

Innovation Solution

The development of a system using a fluid-filled balloon with multiple subsonic pressure wave generators, each comprising a proximal and distal ring electrode with a spark gap, generating subsonic pressure waves that travel through the balloon material at speeds below the speed of sound, allowing for effective disruption of calcified lesions with improved axial coverage and reduced tissue 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 vessel lumen is opened, but the vessel wall tissue suffers damage including arterial rupture, dissection, and formation of hematoma or pseudoaneurysm

Engineering Contradiction:
Improveeffectiveness of occlusion removalVSAvoidvessel 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. Electromagnetic energy is converted to mechanical shock waves through electrical arcs generated between electrodes, which then disrupt calcified lesions without requiring high mechanical pressure that damages vessel walls

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

Solution Approach 2:

The invention changes the fundamental parameter of energy delivery from continuous mechanical pressure to pulsed electrical discharge. The electrical arcs generate shock waves with peak pressures that are highly localized to the calcified material, while the pulsed nature of the discharge allows tissue recovery between pulses, reducing cumulative damage to the vessel wall

Inventive Principle:
Principle #35Parameter changes

2Length of moving object

If multiple electrode pairs are spaced apart axially to treat elongated lesions, then axial coverage is improved, but device complexity increases requiring additional electrode pairs and translatable carriers

Engineering Contradiction:
Improveaxial coverageVSAvoidnumber of electrode pairs
Core Design Contradiction:
Length of moving objectVSDevice complexity

Solution Approach 1:

The patent divides the treatment zone into multiple discrete electrode pairs spaced along the balloon circumference and axis. Each electrode pair acts as an independent treatment module that can be selectively activated, providing modular coverage of elongated lesions without requiring a single complex translatable carrier system

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent designs the electrode pairs to be multi-functional, serving both as treatment elements and as positioning references. The same electrode structure that generates the electrical arc also defines the spatial configuration for treating different segments of the lesion, eliminating the need for separate positioning mechanisms

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 enables more controlled and efficient disruption of calcified lesions with reduced risk of vessel wall damage, providing broader axial coverage and minimizing complications associated with traditional high-pressure angioplasty.

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... Shockwave Medical, Inc., intravascular lithotripsy system generates 'shock waves' within a fluid-filled balloon

Methodology Applied
Scientific EffectPressure wave generation: Shock Wave

Data Source

PatentUS20240197350A1Intravascular lithotripsy systems, devices and methods
Publication Date: 2024.06.20 CARDIOVASCULAR SYSTEMS INC
  • US20240197350A1 patent drawing
  • US20240197350A1 patent drawing
  • US20240197350A1 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 or extensions that allow the electrical arc to form at any one of the plurality of points to, among other things, extend the electrode life.