Shockwave Balloon Catheter for Calcified Lesion Dilation

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Solution Overview

Problem

Percutaneous coronary and peripheral angioplasty procedures face challenges with calcified lesions, as high pressures required to dilate them can cause vessel trauma, dissection, thrombus formation, and restenosis due to the rapid expansion of angioplasty balloons.

Innovation Solution

A catheter system with a dilating balloon and an arc generator using electrodes to produce mechanical shock waves within the balloon, which are synchronized with cardiac R waves and controlled for intensity, allows for the breaking of calcified lesions without excessive pressure, using a fluid like saline that may include x-ray contrast and a guide wire lumen.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If high pressure is applied to dilate calcified lesions, then the lesion can be broken and blood flow restored, but vessel trauma, dissection, and restenosis occur

Engineering Contradiction:

Improvelesion dilation effectivenessVSAvoidvessel trauma

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the conventional mechanical pressure-based dilation system with an electrical discharge system. Electromagnetic energy is delivered through electrodes within the balloon to fracture calcified plaque, substituting mechanical force with electromagnetic field effects. This allows plaque breakdown without the excessive mechanical pressures that cause vessel trauma

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent changes the physical parameter from mechanical pressure to electrical voltage. By applying high voltage electrical discharges (e.g., 1000-5000 volts) through electrodes, the system creates plasma channels and shock waves that fracture calcified lesions. This parameter transformation enables effective plaque modification while avoiding the harmful mechanical stresses associated with traditional high-pressure balloon inflation

Inventive Principle:

Principle #35Parameter changes

2Productivity

If balloon maximum diameter is used to open calcified lesion, then passage way for blood is created, but energy is stored and released causing rapid expansion and vessel wall injury

Engineering Contradiction:

Improvevessel opening effectivenessVSAvoidballoon energy release trauma

Core Design Contradiction:

ProductivityVSObject-generated harmful factors

Solution Approach 1:

The patent applies preliminary electrical discharge action to fracture the calcified plaque before balloon expansion. By delivering electrical energy through electrodes to pre-soften and fracture the calcified lesion, the system reduces the mechanical energy required for subsequent balloon dilation. This preliminary treatment prevents the sudden energy release and rapid expansion that injure vessel walls

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent employs periodic electrical discharges delivered in controlled pulses through the electrodes. Rather than continuous high-pressure inflation, the system uses repeated electrical bursts (e.g., multiple pulses at controlled intervals) to progressively fracture the plaque. This periodic energy delivery allows controlled plaque modification while avoiding the single-event catastrophic energy release that causes vessel trauma

Inventive Principle:

Principle #19Periodic action

3Productivity

If non-concentric calcified lesion is treated with high pressure, then lesion can be opened, but undue stress is placed on free wall of vessel

Engineering Contradiction:

Improvelesion opening capabilityVSAvoidfree wall stress

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent applies local electrical discharge treatment through electrodes positioned within the balloon at the specific site of calcified lesion. The electrical energy is delivered locally to the plaque burden area, creating focused plasma channels and shock waves that fracture calcification only where needed. This localized approach opens the lesion without subjecting the entire vessel, particularly the free wall, to undue mechanical stress from global high-pressure inflation

Inventive Principle:

Principle #3Local quality

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 method effectively breaks down calcified lesions with controlled mechanical shock waves, reducing the risk of vessel trauma and restenosis by distributing energy evenly, allowing for safer and more effective dilation of arteries without the need for high pressures.

Implementation Method 1

an arc generator including at least one electrode within the balloon that forms a mechanical shock wave within the balloon

Methodology Applied

Scientific EffectElectrical arc: Electric Arc

Implementation Method 2

forms a mechanical shock wave within the balloon

Methodology Applied

Scientific EffectShock wave: Shock Wave

Data Source

PatentUS20230380849A1Shockwave balloon catheter system

Publication Date: 2023.11.30 SHOCKWAVE MEDICAL INC

AI summary

A system for breaking obstructions in body lumens includes a catheter including an elongated carrier, a balloon about the carrier in sealed relation thereto, the balloon being arranged to receive a fluid therein that inflates the balloon, and an arc generator including at least one electrode within the balloon that forms a mechanical shock wave within the balloon. The system further includes a power source that provides electrical energy to the arc generator.