Nested Intravascular Lithotripsy Balloon for Tortuous Arteries

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Solution Overview

Problem

Conventional intravascular lithotripsy (IVL) treatments face challenges due to the bulkiness and stiffness of existing balloon and electrode systems, which make it difficult to deliver shockwaves effectively in calcified and tortuous coronary and peripheral arteries.

Innovation Solution

The development of a balloon assembly coupled to an inner catheter and shielded by an outer catheter, allowing for easier insertion and advancement by protecting the balloon assembly and enabling longer balloon lengths compared to conventional systems.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Use of energy by moving object

If conventional IVL balloons and electrodes are used, then shockwave generation capability is achieved, but delivery difficulty increases due to bulkiness and stiffness

Engineering Contradiction:

Improveshockwave generation capabilityVSAvoiddelivery difficulty

Core Design Contradiction:

Use of energy by moving objectVSEase of operation

Solution Approach 1:

The balloon assembly is nested within the outer catheter, which provides a flexible delivery system. The outer catheter can be advanced through tortuous vessels while the balloon remains protected inside, and then deployed at the target site. This nesting approach allows the stiff balloon to be delivered through flexible pathways without compromising either the shockwave generation capability or the ease of delivery.

Inventive Principle:

Principle #7Nested doll (Nesting)

Solution Approach 2:

The IVL system is divided into separate functional components: the inner catheter with balloon assembly for shockwave generation, and the outer catheter for delivery and protection. This segmentation allows each component to be optimized independently - the balloon for energy delivery and the outer catheter for navigability through tortuous vessels.

Inventive Principle:

Principle #1Segmentation

2Length of moving object

If longer balloon assemblies are used, then treatment coverage of calcified vessels is improved, but insertion and advancement difficulty increases

Engineering Contradiction:

Improveballoon assembly lengthVSAvoidinsertion and advancement difficulty

Core Design Contradiction:

Length of moving objectVSEase of operation

Solution Approach 1:

The outer catheter serves as a delivery sheath that accommodates and protects the longer balloon assembly during insertion and advancement through the vascular system. The nested configuration allows the extended balloon to navigate tortuous pathways within the outer catheter's lumen, then be deployed fully at the treatment site to cover longer segments of calcified vessels.

Inventive Principle:

Principle #7Nested doll (Nesting)

Solution Approach 2:

The outer catheter acts as a flexible protective sheath that enables the longer balloon assembly to be advanced through curved and tortuous blood vessels. The flexible nature of the outer catheter allows it to conform to vessel geometry while protecting the balloon, facilitating insertion of longer devices that would otherwise be too stiff to deliver.

Inventive Principle:

Principle #30Flexible shells and thin films

3Ease of operation

If balloon assembly is exposed during insertion, then deployment is simplified, but protection from damage and fish-mouthing increases

Engineering Contradiction:

Improvedeployment simplicityVSAvoiddamage and fish-mouthing risk

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The outer catheter is positioned and advanced to the target site before the balloon assembly is deployed. This preliminary positioning protects the balloon during navigation through the vascular system, preventing damage and fish-mouthing. Once the outer catheter is in place, the balloon is then deployed in a controlled manner at the treatment site.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The outer catheter is selectively retracted or withdrawn from around the balloon assembly at the target site, exposing the balloon for deployment while leaving the balloon protected during the critical advancement phase. This selective extraction allows the balloon to be deployed only when needed at the treatment location.

Inventive Principle:

Principle #2Taking out (Extraction)

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 solution facilitates more efficient and effective delivery of shockwaves to calcified regions, improving treatment outcomes by allowing longer segments of calcified vessels to be treated with reduced procedural time and complexity.

Implementation Method 1

The electrodes may receive high voltage energy pulses with which to generate shockwaves by emitting electric arcs.

Methodology Applied

Scientific EffectElectric arc: Electric Arc

Implementation Method 2

the balloon assembly may be configured to expand or be inflated by the presence of a liquid or a gas.

Methodology Applied

Scientific EffectInflation:

Data Source

PatentUS20250049455A1System and method for efficient intravascular lithotripsy

Publication Date: 2025.02.13 VANTIS VASCULAR INC

AI summary

An intravascular lithotripsy apparatus is disclosed. The apparatus may include a balloon assembly that expands and provides shockwaves for any feasible lumen. The balloon assembly may be shielded by an outer catheter providing a smooth surface to ease advancement through the lumen. Also described herein are locking mechanism for securing dual catheters that may be incorporated with any of the apparatuses described.