Segmented Balloon Catheter for Differential Stent-Valve Dilation

Solution Overview

Problem

Current balloon catheters for post-implantation dilation of self-expanding prosthetic valves lack precision in applying differential dilation forces to avoid damaging the leaflet portion while ensuring proper anchoring, particularly for less-experienced practitioners.

Innovation Solution

A balloon catheter with regions of varying diameters, including a larger diameter region for applying dilation force to the anchor portion and smaller diameter regions for reduced dilation to the leaflet portion, designed to minimize risk of damage and provide stability during inflation, with an optional interface region to bridge diameter differences and a pressure relief valve for safety.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a uniform diameter balloon catheter is used for post-implantation dilation, then the dilation force is applied uniformly to the entire stent-valve, but this may cause damage to the leaflet portion while ensuring anchoring of the anchor portion

Engineering Contradiction:

Improveanchoring reliabilityVSAvoidleaflet damage risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The balloon catheter is divided into multiple axial segments with different diameters: a first axial region with a larger diameter for applying dilation force to the anchor portion, and a second axial region with a smaller diameter for applying reduced dilation to the leaflet portion. This segmentation allows differential force application to protect different components of the stent-valve.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different regions of the balloon catheter are designed with different diameters to provide localized dilation characteristics. The larger diameter first axial region provides strong dilation for anchoring, while the smaller diameter second axial region provides gentle dilation for the leaflet portion, ensuring each region receives appropriate dilation force for its specific function.

Inventive Principle:

Principle #3Local quality

2Reliability

If a larger diameter balloon is used to ensure proper anchoring of the stent-valve, then anchoring reliability is improved, but the risk of damaging the leaflet portion increases

Engineering Contradiction:

Improveanchoring reliabilityVSAvoidleaflet damage risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The balloon catheter is divided into multiple axial segments with different diameters: a first axial region with a larger diameter for applying dilation force to the anchor portion, and a second axial region with a smaller diameter for applying reduced dilation to the leaflet portion. This segmentation allows differential force application to protect different components of the stent-valve.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different regions of the balloon catheter are designed with different diameters to provide localized dilation characteristics. The larger diameter first axial region provides strong dilation for anchoring, while the smaller diameter second axial region provides gentle dilation for the leaflet portion, ensuring each region receives appropriate dilation force for its specific function.

Inventive Principle:

Principle #3Local quality

3Object-affected harmful factors

If a smaller diameter balloon is used to protect the leaflet portion, then leaflet damage risk is reduced, but anchoring reliability is compromised

Engineering Contradiction:

Improveleaflet damage riskVSAvoidanchoring reliability

Core Design Contradiction:

Object-affected harmful factorsVSReliability

Solution Approach 1:

The balloon catheter is divided into multiple axial segments with different diameters: a first axial region with a larger diameter for applying dilation force to the anchor portion, and a second axial region with a smaller diameter for applying reduced dilation to the leaflet portion. This segmentation allows differential force application to protect different components of the stent-valve.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different regions of the balloon catheter are designed with different diameters to provide localized dilation characteristics. The larger diameter first axial region provides strong dilation for anchoring, while the smaller diameter second axial region provides gentle dilation for the leaflet portion, ensuring each region receives appropriate dilation force for its specific function.

Inventive Principle:

Principle #3Local quality

4Measurement precision

If a balloon catheter with varying diameter regions is used, then differential dilation control is improved, but the device complexity increases

Engineering Contradiction:

Improvedilation force control precisionVSAvoidballoon structure complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The balloon catheter is divided into multiple axial segments with different diameters: a first axial region with a larger diameter for applying dilation force to the anchor portion, and a second axial region with a smaller diameter for applying reduced dilation to the leaflet portion. This segmentation allows differential force application to protect different components of the stent-valve.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different regions of the balloon catheter are designed with different diameters to provide localized dilation characteristics. The larger diameter first axial region provides strong dilation for anchoring, while the smaller diameter second axial region provides gentle dilation for the leaflet portion, ensuring each region receives appropriate dilation force for its specific function.

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

Facilitates controlled and safe post-implantation dilation, reducing the risk of leaflet damage and ensuring proper anchoring, while providing rapid inflation capabilities through a sufficiently sized inflation lumen, thereby improving procedural efficiency and patient outcomes.

Implementation Method 1

an inflatable region shaped for applying a dilation force to an anchor portion of a stent-valve

Methodology Applied

Scientific EffectInflation: Pressure Increase

Implementation Method 2

with an optional interface region to bridge diameter differences and a pressure relief valve for safety

Methodology Applied

Scientific EffectPressure relief: Depressurisation

Data Source

PatentEP3316819B1Balloon catheter for prosthetic valves

Publication Date: 2020.11.11 SYMETIS

Figure 1

AI summary

A balloon catheter (8) for post-implantation dilation of a self-expanding stent- valve (12) that comprises a stent component (14) and a valve component (16), the balloon catheter comprising an inflatable region (10) shaped to include a first region (30) configured for applying a dilation force to an anchor portion (18) of the stent-component, and at least one second region (32a/b) for applying less dilation to a leaflet portion (24) of the valve component, wherein the first region (30) has a larger diameter than the second region (32a/b).