Shockwave Catheter Follower Arrangement Maintains Distance

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Solution Overview

Problem

The effectiveness of shock wave therapy for aortic valve stenosis decreases as the distance between the shock wave generator and the valve leaflets increases during balloon expansion, requiring longer treatment times and more shock waves to achieve complete dilation.

Innovation Solution

A catheter with an inflatable balloon and a follower arrangement that maintains the shock wave source at a substantially fixed distance from the inner surface of the balloon using a biasing mechanism, such as a spring or flexible stand-offs, to ensure consistent therapy effectiveness during valve dilation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Volume of moving object

If the balloon is inflated to dilate the valve, then the valve opening increases, but the distance between the shock wave generator and the balloon wall increases causing therapy effectiveness to decrease

Engineering Contradiction:
Improvevalve openingVSAvoidtherapy effectiveness
Core Design Contradiction:
Volume of moving objectVSReliability

Solution Approach 1:

The shock wave generator is mounted on a follower arrangement that dynamically adjusts its position relative to the balloon wall during inflation. The biasing means (spring or flexible stand-offs) allow the generator to move closer to the wall as the balloon expands, maintaining an optimal substantially fixed distance throughout the dilation process, thus preserving therapy effectiveness while the valve opening increases

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The follower arrangement acts as an intermediary mechanism between the shock wave generator and the balloon wall. It includes biasing means (spring or flexible stand-offs) that mediate the interaction, allowing the generator to maintain a controlled substantially fixed distance from the wall while accommodating balloon expansion, thereby ensuring consistent shock wave delivery effectiveness

Inventive Principle:
Principle #24Intermediary (Mediator)

2Length of moving object

If the distance between the shock wave generator and the valve leaflets increases, then the valve can be opened wider, but the shock wave effectiveness decreases requiring more shock waves and longer treatment time

Engineering Contradiction:
Improvevalve dilationVSAvoidtreatment time
Core Design Contradiction:
Length of moving objectVSLoss of time

Solution Approach 1:

The follower arrangement with biasing means enables dynamic position adjustment of the shock wave generator during balloon inflation. By maintaining a substantially fixed optimal distance from the balloon wall throughout the dilation process, the system preserves shock wave effectiveness, allowing wider valve opening to be achieved without increasing treatment time

Inventive Principle:
Principle #15Dynamics

3Length of moving object

If the distance between the shock wave generator and the valve leaflets increases, then the valve can be dilated more, but the number of shock waves required increases

Engineering Contradiction:
Improvevalve dilationVSAvoidtreatment efficiency
Core Design Contradiction:
Length of moving objectVSProductivity

Solution Approach 1:

The follower arrangement dynamically maintains the shock wave generator at a substantially fixed optimal distance from the balloon wall during inflation. This dynamic positioning ensures consistent shock wave effectiveness throughout the dilation process, achieving greater valve dilation without increasing the number of shock waves required, thus maintaining high treatment efficiency

Inventive Principle:
Principle #15Dynamics

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 configuration maintains the shock wave source's effectiveness throughout the treatment, reducing treatment time and the number of shock waves needed to effectively break up calcification and dilate the valve.

Implementation Method 1

When a high voltage pulse is applied across the electrodes, an electrical arc is formed. The electrical arc creates a shock wave within the fluid

Methodology Applied
Scientific EffectElectrical arc: Electric Arc

Implementation Method 2

The electrical arc creates a shock wave within the fluid that propagates to the balloon walls to impinge upon the valve leaflets and the calcification on the valve

Methodology Applied
Scientific EffectShock wave: Shock Wave

Implementation Method 3

The follower arrangement may include at least one stand-off extending from the electrode pair. The stand-off may be formed of flexible material.

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 4

The catheter may further include a biasing member carried by the elongated lead that biases the elongated lead towards the inner surface of the inflatable balloon. The biasing member may be a spring.

Methodology Applied
Scientific EffectSpring mechanism: Spring

Data Source

PatentEP2879597B1Shockwave catheter
Publication Date: 2016.09.21 SHOCKWAVE MEDICAL INC
  • EP2879597B1 patent drawingFigure 1~2
  • EP2879597B1 patent drawingFigure 3
  • EP2879597B1 patent drawingFigure 4

AI summary

A catheter (10), for use, for example, in valvuloplasty, includes an elongated body (12) and an inflatable balloon (14) carried by the elongated body (12). The balloon (14) has an inner surface (16) and an outer surface (18). The catheter (10) further includes at least one shock wave source (20) within the inflatable balloon (14) and a follower arrangement (30) that maintains the at least one shock wave source (20) a substantially fixed distance from the inner surface (16).of the balloon.