Variable Rigidity Balloon Catheter for Coronary Sinus Occlusion

Solution Overview

Problem

Balloon catheters used for intermittent occlusion of the coronary sinus face challenges such as difficulty in precise placement due to the need for skilled insertion and risk of slipping or kinking under blood pressure, which prolongs treatment duration and increases patient strain.

Innovation Solution

A balloon catheter design that combines sufficient rigidity to prevent slipping and flexibility to navigate curved vessels, featuring a central lumen for pressure measurement and a stiffening element with variable flexural strength to facilitate safe advancement and maintain balloon position, along with a separate lumen for balloon inflation and pressure monitoring to prevent buckling.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the catheter is made sufficiently rigid to prevent slipping and kinking under blood pressure, then the reliability of balloon position is improved, but the ease of operation deteriorates due to difficulty in navigating curved vessels

Engineering Contradiction:

Improveballoon position stabilityVSAvoidcatheter navigation

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The catheter shaft is divided into multiple sections with different flexural rigidities. The proximal portion has higher rigidity to prevent slipping and kinking under blood pressure during occlusion, while the distal portion has lower rigidity to enable safe navigation through curved vessel regions. This segmentation allows each section to perform its specific function optimally.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different portions of the catheter shaft are assigned different mechanical properties. The proximal portion is designed with higher flexural rigidity to provide stability and prevent slipping, while the distal portion is designed with lower flexural rigidity to provide flexibility for navigation. This local differentiation of properties resolves the contradiction between stability and navigability.

Inventive Principle:

Principle #3Local quality

2Ease of operation

If the catheter is made sufficiently flexible to navigate curved vessels safely, then the ease of operation is improved, but the reliability deteriorates due to increased likelihood of slipping and kinking under blood pressure

Engineering Contradiction:

Improvecatheter navigationVSAvoidballoon position stability

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The catheter shaft is divided into multiple sections with different flexural rigidities. The proximal portion has higher rigidity to prevent slipping and kinking under blood pressure during occlusion, while the distal portion has lower rigidity to enable safe navigation through curved vessel regions. This segmentation allows each section to perform its specific function optimally.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different portions of the catheter shaft are assigned different mechanical properties. The proximal portion is designed with higher flexural rigidity to provide stability and prevent slipping, while the distal portion is designed with lower flexural rigidity to provide flexibility for navigation. This local differentiation of properties resolves the contradiction between stability and navigability.

Inventive Principle:

Principle #3Local quality

3Adaptability or versatility

If multiple lumens are added for pressure measurement and balloon inflation, then the functionality is improved, but the device complexity increases

Engineering Contradiction:

Improvepressure control capabilityVSAvoidcatheter structure

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

Multiple lumens for different functions (pressure measurement, balloon inflation, deflation) are integrated within a single catheter shaft structure. The pressure sensor lumen, inflation lumen, and deflation lumen are all incorporated into one device, allowing simultaneous pressure monitoring and balloon control without requiring separate catheters.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The catheter shaft is designed as a multi-functional device that simultaneously performs pressure measurement, balloon inflation, and deflation functions through its multiple lumens. This universal design allows a single device to replace what would otherwise require multiple separate devices, managing complexity through integration.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Data Source

PatentUS10743780B2Catheter system and method for occluding a body vessel

Publication Date: 2020.08.18 MIRACOR MEDICAL SA

AI summary

Some embodiments of a balloon catheter device for introduction into a body vessel, in particular the coronary sinus, can include a catheter shaft which carries an inflatable balloon on its distal portion and in which a plurality of different lumens are formed. In particular embodiments, a system for treating heart tissue can include a coronary sinus occlusion catheter configured for improved deliverability to the coronary sinus and for thereafter performing intermittent occlusion of the coronary sinus.