Thermal Ablation System Fluid Pressure and Temperature Control

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Solution Overview

Problem

Current less invasive procedures for treating menorrhagia, such as thermal ablation, often require direct visualization and skilled operator intervention, and may not efficiently manage fluid pressure and temperature distribution within the uterus.

Innovation Solution

A thermal ablation system comprising a console with a fluid handling unit, a heater, and an introducer with a sheath for delivering and returning heated fluid, featuring a height-adjusting mechanism to control fluid pressure and a valve arrangement for precise fluid flow management, allowing for automated and controlled thermal ablation of the uterine lining.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If direct visualization and skilled operator intervention are used in thermal ablation procedures, then treatment precision can be achieved, but procedural complexity and operator dependency increase

Engineering Contradiction:
Improvetreatment precisionVSAvoidprocedural complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The system enables self-service operation through automated fluid circulation and temperature control. The pump automatically circulates fluid through the uterine cavity, the heater maintains predetermined temperature, and the pressure regulator controls fluid pressure without requiring continuous operator intervention or direct visualization during the ablation process.

Inventive Principle:
Principle #25Self-service

2Quantity of substance

If heated fluid is circulated through the uterus for thermal ablation, then treatment coverage is improved, but fluid pressure and temperature distribution control become challenging

Engineering Contradiction:
Improvefluid distribution coverageVSAvoidpressure and temperature control precision
Core Design Contradiction:
Quantity of substanceVSManufacturing precision

Solution Approach 1:

The system incorporates feedback control through temperature sensors that continuously monitor the fluid temperature and provide signals to the controller, which adjusts the heater accordingly to maintain predetermined temperature. Similarly, pressure regulation provides feedback control to maintain optimal fluid pressure throughout the circulation process, ensuring consistent treatment delivery.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system maintains predetermined temperature and pressure parameters throughout the fluid circulation process. The controller regulates the heater and pressure regulator to keep these parameters constant, ensuring uniform thermal ablation treatment throughout the uterine cavity without variation in treatment intensity.

Inventive Principle:
Principle #35Parameter changes

3Adaptability or versatility

If manual operation of thermal ablation systems is used, then flexibility in procedure adjustment is maintained, but consistency and reproducibility of treatment decrease

Engineering Contradiction:
Improveprocedure flexibilityVSAvoidtreatment consistency
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The system replaces manual mechanical operation with automated mechanical and electronic control. The pump, heater, and pressure regulator are controlled by an electronic controller that automatically manages fluid circulation, heating, and pressure regulation according to predetermined parameters, eliminating variability introduced by manual operation while maintaining procedural flexibility through programmable settings.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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

Enables efficient and controlled thermal ablation of the uterine lining with reduced operator intervention, ensuring consistent fluid pressure and temperature distribution, thereby improving the efficacy and safety of the procedure.

Implementation Method 1

a heater heating the fluid to a desired temperature

Methodology Applied
Scientific EffectHeating: Heating

Implementation Method 2

the pump increases a pressure of the fluid between the fluid source and the delivery lumen of the introducer

Methodology Applied
Scientific EffectPressure increase: Pressure Increase

Implementation Method 3

a delivery lumen introducing fluid heated by the heater to the hollow organ and a return lumen withdrawing fluid from the hollow organ

Methodology Applied
Scientific EffectThermal conduction: Conduction (thermal)

Data Source

PatentEP2207492B1Thermal ablation system
Publication Date: 2018.03.07 BOSTON SCIENTIFIC SCIMED INC
  • EP2207492B1 patent drawingFigure 1
  • EP2207492B1 patent drawingFigure 2
  • EP2207492B1 patent drawingFigure 3

AI summary

A thermal ablation system comprises a fluid handling unit receiving fluid from a fluid source at a first pressure, the fluid handling unit including a heater heating the fluid to a desired temperature and a pump and an introducer including a sheath which, when in an operative position, is received within a hollow organ, the sheath including a delivery lumen introducing fluid heated by the heater to the hollow organ and a return lumen withdrawing fluid from the hollow organ and returning the withdrawn fluid to the console via a return lumen, wherein the pump increases a pressure of the fluid between the fluid source and the delivery lumen of the introducer.