Segmented Balloon Catheter with Interstitial Gel for Cardiac Tissue Contact

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Solution Overview

Problem

Existing medical devices face challenges in securely placing and maintaining position on uneven cardiac tissue surfaces during minimally invasive procedures, particularly in the left atrium, due to irregular topography and anatomical variations, which can lead to tissue damage or displacement.

Innovation Solution

An intravascular catheter with a first expandable member and a second expandable member defining an interstitial region, filled with a gel or liquid agent, providing a coolant flow path and a cryogenic coolant source, along with a fluid ingress detection system, to ensure secure placement and minimize tissue injury.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a single expandable balloon is used to contact tissue, then the device structure is simple, but it cannot securely maintain position on uneven cardiac tissue surfaces

Engineering Contradiction:

Improvesecure placementVSAvoiddevice structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The single balloon is divided into multiple segmented balloons (first, second, third, and fourth balloons) arranged in series. Each balloon can independently expand to contact the tissue surface, allowing the device to adapt to uneven topography while maintaining secure placement through multiple contact points rather than relying on a single large balloon.

Inventive Principle:

Principle #1Segmentation

2Reliability

If excessive force is applied to maintain device contact with tissue, then the device remains securely positioned, but tissue damage or device displacement occurs

Engineering Contradiction:

Improvedevice positioningVSAvoidtissue damage

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The balloons are designed with dynamic expansion and compression capabilities, allowing them to adapt their contact force to the tissue surface. The balloons can expand to make contact, maintain positioning through controlled compression, and compress to release force, preventing tissue damage while avoiding device displacement.

Inventive Principle:

Principle #15Dynamics

3Adaptability or versatility

If the device is designed to conform to irregular tissue surfaces, then secure contact is achieved, but the device loses rigidity needed for stable positioning

Engineering Contradiction:

Improveconformance to surfaceVSAvoiddevice rigidity

Core Design Contradiction:

Adaptability or versatilityVSStability of the object's composition

Solution Approach 1:

The device uses multiple discrete balloon segments rather than a single continuous compliant structure. Each balloon can independently conform to local surface irregularities while the collective arrangement of segmented balloons maintains overall structural stability and rigidity for stable positioning.

Inventive Principle:

Principle #1Segmentation

4Area of stationary object

If a large expandable balloon is used to cover irregular surfaces, then tissue contact area is increased, but the balloon cannot adapt to anatomical variations between patients

Engineering Contradiction:

Improvetissue contact areaVSAvoidanatomical adaptation

Core Design Contradiction:

Area of stationary objectVSAdaptability or versatility

Solution Approach 1:

Instead of one large balloon, the device uses multiple smaller balloons arranged in series. This segmentation allows each balloon to adapt to local anatomical variations between patients while collectively providing sufficient total contact area for effective treatment.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The balloons can dynamically expand and compress to adapt to different anatomical configurations. This dynamic capability allows the same device to accommodate anatomical variations between patients while maintaining adequate tissue contact area for treatment effectiveness.

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

The catheter enables secure positioning on uneven surfaces, reducing the risk of tissue damage by using a gel or liquid agent with controlled viscosity and thermal conductivity, and a dual expandable structure to maintain contact and prevent unwanted displacement during procedures like RF ablation.

Implementation Method 1

An intravascular catheter with a first expandable member and a second expandable member defining an interstitial region, filled with a gel or liquid agent

Methodology Applied

Scientific EffectThermal insulation: Thermal Insulation

Implementation Method 2

providing a coolant flow path and a cryogenic coolant source, along with a fluid ingress detection system

Methodology Applied

Scientific EffectHeat transfer: Conduction (thermal)

Data Source

PatentEP2528527B1Partially compliant balloon device

Publication Date: 2020.01.01 MEDTRONIC CRYOCATH LP

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AI summary

A medical device is provided, having an elongate body defining a distal portion and a proximal portion; a first expandable member disposed on the distal portion of the elongate body and defining a cooling chamber therein, the first expandable member having a first rigidity; a second expandable member disposed around the first expandable member to define an interstitial region therebetween, where the second expandable member has a second rigidity less than the first rigidity; a gel disposed within the interstitial region; a coolant flow path in fluid communication with the cooling chamber; and a cryogenic coolant source in fluid communication with the coolant flow path.