Uterine Cavity Integrity Detection via Fluid Flow Monitoring

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Solution Overview

Problem

Existing endometrial ablation technologies face challenges such as slow treatment times, incomplete treatments, non-uniform ablation depths, and risk of injury to adjacent organs, particularly due to uncertainties in uterine cavity integrity during procedures.

Innovation Solution

A method and system that assess uterine cavity integrity by introducing a fluid flow through a probe into the uterine cavity and monitoring the flow rate to characterize the cavity as perforated or non-perforated, enabling controlled and safe radiofrequency ablation only when the cavity is intact.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If radiofrequency ablation is performed without verifying uterine cavity integrity, then treatment speed is improved, but risk of injury to adjacent organs increases

Engineering Contradiction:
Improvetreatment speedVSAvoidrisk of injury to adjacent organs
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The system performs a preliminary integrity test by introducing a fluid flow through the probe into the uterine cavity before ablation. The controller monitors the flow rate to determine if the uterine wall is intact or perforated. Only after confirming integrity does the system enable ablation treatment, thus preventing injury to adjacent organs while maintaining treatment efficiency.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If fluid flow monitoring is implemented to check uterine cavity integrity, then safety is improved, but device complexity increases

Engineering Contradiction:
ImprovesafetyVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The probe serves multiple functions: it acts as both the ablation electrode and the fluid delivery conduit for integrity testing. The same probe structure is used to deliver radiofrequency energy and to monitor fluid flow characteristics, eliminating the need for separate testing devices and reducing overall system complexity.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The controller continuously monitors the fluid flow rate through the probe and provides feedback to determine uterine cavity integrity. Based on this feedback, the controller enables or disables the ablation function. This automated feedback mechanism ensures safety without requiring complex manual monitoring procedures.

Inventive Principle:
Principle #23Feedback

3Measurement precision

If a fluid flow test is performed before ablation, then accuracy of cavity integrity assessment is improved, but treatment time increases

Engineering Contradiction:
Improveaccuracy of cavity integrity assessmentVSAvoidtreatment time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The fluid flow monitoring is performed continuously during probe insertion and positioning, rather than as a separate discrete step. The integrity assessment occurs in real-time as part of the overall treatment workflow, minimizing interruption to the treatment process and reducing total treatment time while maintaining high measurement accuracy.

Inventive Principle:
Principle #20Continuity of useful action

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

This approach allows for rapid, controlled, and safe endometrial ablation by ensuring the uterine cavity is intact before proceeding with the procedure, reducing the risk of injury to adjacent organs and improving treatment efficiency.

Implementation Method 1

providing a flow of a fluid (e.g., CO2) through the probe into the uterine cavity and monitoring the rate of the flow to characterize the uterine cavity as perforated or non-perforated based on a change in the flow rate

Methodology Applied
Scientific EffectFluid flow monitoring:

Data Source

PatentUS11382557B2Systems and methods for evaluating the integrity of a uterine cavity
Publication Date: 2022.07.12 AXORA MEDICAL INC
  • US11382557B2 patent drawing
  • US11382557B2 patent drawing
  • US11382557B2 patent drawing

AI summary

A system for accessing a patient's uterine cavity and detecting perforations in the uterus includes an elongated probe having a flow channel extending to a terminal outlet in a distal region of the probe. A fluid source is coupled to the flow channel, and a seal on the probe is positionable in an endocervical canal. The probe may be trans-cervically inserted into the uterine cavity, and a fluid may be introduced through the channel to flow outwardly from the terminal outlet into the uterine cavity. A parameter of said fluid flow is monitored to detect a perforation in the uterus.