Shock Wave Balloon Catheter for Calcified Lesion Treatment

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Solution Overview

Problem

Percutaneous coronary and peripheral angioplasty procedures face challenges with calcified lesions, as high pressures required to break these lesions can cause vessel trauma, dissection, thrombus formation, and restenosis, especially when using conventional dilation catheters and balloons.

Innovation Solution

A catheter system with a balloon that generates mechanical shock waves to break calcified lesions without excessive pressure, while simultaneously releasing medicinal agents, such as microspheres or microcapsules, to reduce restenosis risk.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If high pressures are used to break calcified lesions, then the calcified plaque can be broken and blood flow restored, but vessel trauma, dissection, thrombus formation, and restenosis occur

Engineering Contradiction:

Improveforce to break calcified lesionVSAvoidvessel trauma and restenosis

Core Design Contradiction:

StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the conventional mechanical pressure-based lesion breaking system with an acoustic shock wave system. Shock waves are generated within the balloon using piezoelectric or piezocomposite materials that convert electrical energy to mechanical shock waves, which then break the calcified plaque without requiring high inflation pressures that cause vessel trauma

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent changes the physical state and delivery mechanism of the medicinal agent by using shock waves to trigger drug release from microcapsules or microspheres. The shock waves cause phase changes or structural breakdown of the microcapsule materials (polymer, starch, or glucose-based), releasing the encapsulated drug at the lesion site without requiring high balloon pressures

Inventive Principle:

Principle #35Parameter changes

2Productivity

If high inflation pressures are applied to open calcified lesions, then blood flow passage is restored, but energy is stored and released causing rapid balloon expansion and vessel wall injury

Engineering Contradiction:

Improvelesion opening efficiencyVSAvoidvessel wall stress and injury

Core Design Contradiction:

ProductivityVSObject-generated harmful factors

Solution Approach 1:

The patent substitutes the mechanical pressure-inflation system with an acoustic shock wave system for lesion modification. The shock waves are generated internally within the balloon using piezoelectric elements, allowing precise control of energy delivery to the calcified plaque without the need for high inflation pressures that lead to dangerous energy storage and sudden release

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent employs periodic or pulsed shock wave delivery rather than continuous high pressure. The shock waves can be delivered in controlled bursts, allowing energy to be dissipated safely without accumulating in the balloon wall, thereby preventing the rapid expansion and vessel injury associated with continuous high-pressure inflation

Inventive Principle:

Principle #19Periodic action

3Reliability

If anti-proliferative drugs are coated on stent surface, then restenosis due to cell proliferation is prevented long term, but drug delivery to the site of balloon expansion is limited

Engineering Contradiction:

Improverestenosis preventionVSAvoiddrug delivery to lesion site

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The patent applies preliminary action by pre-encapsulating the medicinal agent in microcapsules or microspheres that are carried on the balloon surface before deployment. These microcapsules are designed to break open upon exposure to shock waves, releasing the drug directly at the lesion site before stent deployment, ensuring immediate local drug delivery rather than relying solely on stent coating

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent introduces microcapsules and microspheres as intermediary carriers for the medicinal agent. These carriers protect the drug during delivery and enable controlled release at the target site through shock wave activation, serving as a mediator between the drug and the lesion site, improving delivery efficiency compared to direct stent coating alone

Inventive Principle:

Principle #24Intermediary (Mediator)

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

The shock wave generator allows for controlled breaking of calcified lesions without vessel injury and enhances drug delivery to the affected area, reducing restenosis and improving blood flow without the need for high inflation pressures.

Implementation Method 1

a shock wave generator within the balloon that forms mechanical shock waves within the balloon

Methodology Applied

Scientific EffectShock wave: Shock Wave

Data Source

PatentUS11517338B2Drug delivery shock wave balloon catheter system

Publication Date: 2022.12.06 SHOCKWAVE MEDICAL INC

AI summary

A catheter comprises an elongated carrier and a balloon carried by the carrier in sealed relation thereto. The balloon has an outer surface and is arranged to receive a fluid therein that inflates the balloon. The catheter further comprises a shock wave generator within the balloon that forms mechanical shock waves within the balloon, and a medicinal agent carried on the outer surface of the balloon. The medicinal agent is releasable from the balloon either before or in response to the shock wave.