Cryoablation Catheter Pressure Regulation Using Check Valves

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Cryoablation systems face challenges in maintaining predictable expansion element deflation shapes during tissue ablation procedures, leading to potential immobilization or obstruction issues due to undesirable pressure levels within the inter-expansion-element space.

Innovation Solution

A pressure regulation system using two or more check valves is integrated along the fluid pathway to passively regulate pressure within the inter-expansion-element space, ensuring safe and controlled pressure levels by comparing pressures to ambient or fluid-drawing source levels, preventing excessive pressure drops that cause unpredictable expansion element shapes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If pressure regulation is not implemented in the inter-expansion-element space, then the system structure remains simple, but the expansion element deflation becomes unpredictable and may cause immobilization or obstruction issues

Engineering Contradiction:
Improvepredictability of expansion element deflationVSAvoidstructure of pressure regulation system
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The pressure regulation system is segmented into multiple independent check valves (first check valve between inter-expansion-element space and fluid-drawing source region, second check valve between first region and external environment). This segmentation allows each valve to independently control pressure differentials, ensuring reliable deflation while maintaining manageable structural complexity through modular design.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The first check valve acts as an intermediary component between the inter-expansion-element space and the fluid-drawing source region, mediating pressure control. This intermediary structure enables predictable pressure regulation during deflation without requiring direct complex control mechanisms, thus improving reliability while limiting complexity growth.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If excessive pressure drops are allowed in the inter-expansion-element space, then the pressure regulation system becomes simpler, but the expansion element develops unpredictable shapes causing catheter immobilization

Engineering Contradiction:
Improveretraction and movement of catheterVSAvoidpressure regulation system
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The pressure regulation system implements preliminary anti-action by using check valves to prevent excessive pressure drops before they can occur. The first check valve anticipates and counteracts potential pressure drops by maintaining minimum pressure thresholds, ensuring the expansion element maintains predictable shapes throughout deflation, thus preserving ease of catheter operation.

Inventive Principle:
Principle #9Preliminary anti-action

Solution Approach 2:

The system controls pressure parameters within the inter-expansion-element space by using check valves to maintain pressure differentials within specific ranges. This parameter control ensures the expansion element transitions through predictable shape changes during deflation, preventing immobilization while avoiding excessive system complexity through passive pressure regulation.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If passive pressure regulation using check valves is implemented, then unsafe pressure conditions are prevented, but the device complexity increases

Engineering Contradiction:
Improvecontrol of pressure differentialsVSAvoidnumber of check valves
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The pressure regulation system uses self-service mechanisms through passive check valves that automatically regulate pressure differentials without requiring external control systems. The check valves self-regulate based on pressure conditions, improving reliability through automatic safety control while minimizing device complexity by eliminating the need for active control mechanisms, sensors, or power sources.

Inventive Principle:
Principle #25Self-service

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 pressure regulation system maintains stable and predictable expansion element deflation, facilitating easy retraction and movement of the catheter, thereby enhancing procedural efficiency and safety by controlling pressure differentials and preventing unsafe pressure conditions.

Implementation Method 1

The pressure regulation system uses two or more check valves and is configured and arranged to passively regulate the pressure within the inter-expansion-element space

Methodology Applied
Scientific EffectCheck valve mechanism: Valve

Data Source

PatentEP2459091B1Systems regulating pressure levels in an inter-expansion-element space of a cryoablation system
Publication Date: 2016.02.10 BOSTON SCIENTIFIC SCIMED INC
  • EP2459091B1 patent drawingFigure 1
  • EP2459091B1 patent drawingFigure 2A
  • EP2459091B1 patent drawingFigure 2B

AI summary

A cryoablation catheter assembly includes a catheter having a coolant outtake region and receives a guide tube and a coolant transfer tube. The coolant transfer tube receives and transfers coolant from a coolant source to an expansion element coupled to a distal portion of the catheter. The expansion element includes an outer layer disposed over an inner layer such that the expansion element defines an inter- expansion-element space between the inner layer and the outer layer and an intra- expansion-element space within the inner layer. The intra-expansion-element space is in fluid communication with the coolant outtake region and the coolant transfer tube. The inter-expansion-element space is in fluid communication with a fluid pathway that transfers fluids to a fluid-drawing source. A pressure regulation system is disposed along the fluid pathway and passively regulates the pressure in the inter- expansion-element space using at least one check valve.