Multi-Stage Pressure Regulator for Cryoablation Balloon Inflation

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Solution Overview

Problem

Current systems for controlling balloon inflation and cryotherapy delivery in pulmonary vein isolation procedures lack precision and efficiency, leading to suboptimal occlusion and ablation of cardiac tissue during cryoablation treatments for arrhythmias.

Innovation Solution

A cryogenic ablation catheter balloon inflation system featuring a fluid source and a multi-stage pressure regulating system that transitions the fluid from a liquid to a gas state, allowing for precise control of inflation pressure, ensuring effective occlusion and ablation while minimizing adverse temperature changes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If a single-stage pressure regulator is used to inflate the cryogenic ablation catheter balloon, then the device complexity is reduced, but the precision and efficiency of balloon inflation control deteriorates

Engineering Contradiction:
Improvepressure regulation system complexityVSAvoidinflation pressure control precision
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The pressure regulation system is divided into multiple stages, with each stage performing a specific function: the first stage reduces high pressure to intermediate pressure, and the second stage reduces intermediate pressure to the final low inflation pressure. This segmentation allows each regulator to operate within optimal pressure ranges, improving control precision while keeping individual stages relatively simple.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

An intermediate pressure stage is introduced between the high-pressure source and the final low-pressure requirement. This intermediate stage acts as a mediator that逐步 reduces pressure, preventing excessive pressure drops in a single stage and enabling more precise final pressure control for balloon inflation.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

If high pressure is applied to inflate the balloon quickly, then the productivity of the procedure is improved, but the harmful factors affecting the tissue increase due to uncontrolled temperature changes

Engineering Contradiction:
Improveballoon inflation speedVSAvoidtissue temperature damage
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The pressure reduction process is segmented into multiple stages, allowing controlled expansion of the cryogenic fluid. This prevents rapid uncontrolled expansion that would cause excessive cooling and tissue damage, while still achieving relatively quick inflation through the efficient multi-stage process.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system utilizes the phase transition of cryogenic fluid from liquid to gas in a controlled manner across multiple pressure stages. By managing this phase transition gradually through intermediate pressure reduction, the system achieves rapid balloon inflation while controlling the temperature drop to prevent tissue damage.

Inventive Principle:
Principle #36Phase transitions

3Device complexity

If the fluid pressure is reduced in a single stage, then the device complexity is reduced, but the temperature control precision deteriorates leading to adverse temperature changes

Engineering Contradiction:
Improvepressure regulation system complexityVSAvoidfluid temperature control
Core Design Contradiction:
Device complexityVSTemperature

Solution Approach 1:

The pressure reduction is divided into two distinct stages, with each stage contributing to controlled temperature management. The first stage handles the primary pressure reduction with associated temperature change, while the second stage completes the pressure reduction with finer temperature control, ensuring the fluid reaches the appropriate temperature for safe balloon inflation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The intermediate pressure stage serves as a thermal mediator, allowing the cryogenic fluid to gradually adjust its temperature as pressure is reduced. This prevents sudden temperature drops that would occur with single-stage pressure reduction, maintaining temperature control within safe ranges for tissue exposure.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 system achieves improved precision and efficiency in balloon inflation and cryotherapy delivery, enhancing the effectiveness of pulmonary vein isolation procedures by maintaining consistent balloon pressure and reducing tissue damage.

Implementation Method 1

a first stage configured to cause the fluid to transition from the liquid state to a gas state

Methodology Applied
Scientific EffectPhase change: Phase Change

Implementation Method 2

a multi-stage pressure regulating system... configured to receive the fluid at a first pressure and to discharge the fluid at a second pressure that is lower than the first pressure

Methodology Applied
Scientific EffectPressure reduction: Pressure Drop

Data Source

PatentUS11684403B2System and method for inflating a cryoablation balloon catheter
Publication Date: 2023.06.27 BOSTON SCIENTIFIC SCIMED INC
  • US11684403B2 patent drawing
  • US11684403B2 patent drawing
  • US11684403B2 patent drawing

AI summary

A system for inflating a cryogenic ablation catheter balloon, the system comprising a fluid source containing a fluid in a liquid state, a first supply line fluidly coupled to the fluid source and configured to be fluidly coupled to an internal space within the cryogenic ablation catheter balloon, the first supply line including an inline multi-stage pressure regulating system. The multi-stage pressure regulating system includes a first stage configured to cause the fluid to transition from the liquid state to a gas state, and a second stage downstream of the first stage configured to maintain the fluid downstream of the second stage at a pressure corresponding to an inflation pressure of cryogenic ablation catheter balloon.