Uterine Cavity Integrity Probe with 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 risks of injury to adjacent organs due to perforated uterine cavities, which are not adequately addressed by current methods for evaluating uterine integrity before proceeding with ablation procedures.

Innovation Solution

A method involving the transcervical introduction of a probe into the uterine cavity, with a flow of fluid (e.g., CO2) to characterize the cavity as perforated or non-perforated based on flow rate changes, enabling controlled radiofrequency ablation only when the cavity is intact, using a system with a gas flow controller and energy delivery surface activation/deactivation depending on uterine integrity assessment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If radiofrequency ablation is performed without adequate uterine integrity assessment, 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 uterine integrity assessment using fluid pressure monitoring and flow rate detection before initiating radiofrequency ablation. This preliminary action identifies perforations in the uterine wall, allowing the operator to correct them before ablation, thereby preventing injury to adjacent organs while maintaining efficient treatment progression

Inventive Principle:

Principle #10Preliminary action

2Device complexity

If traditional electrode designs are used for endometrial ablation, then device complexity is reduced, but treatment completeness and uniformity deteriorate

Engineering Contradiction:

Improvedevice simplicityVSAvoidablation depth uniformity

Core Design Contradiction:

Device complexityVSManufacturing precision

Solution Approach 1:

The ablation catheter incorporates multiple segmented electrodes distributed along its length, each capable of independent radiofrequency energy delivery. This segmentation allows for uniform ablation across different regions of the endometrium, ensuring complete and consistent treatment while maintaining a relatively simple overall device structure

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The system applies radiofrequency energy through multiple localized electrode contacts that can be independently controlled. This allows for tailored energy delivery to specific regions of the endometrium, ensuring uniform ablation depth and complete treatment coverage while keeping the device design straightforward

Inventive Principle:

Principle #3Local quality

3Measurement precision

If fluid flow rate monitoring is implemented for uterine integrity assessment, then detection precision is improved, but device complexity increases

Engineering Contradiction:

Improveperforation detection accuracyVSAvoidassessment system complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The system utilizes the patient's own physiological response to fluid pressure changes as the indicator of uterine integrity. By monitoring flow rate variations and pressure changes during fluid instillation, the system self-identifies perforations without requiring additional complex sensors or external monitoring equipment, thereby maintaining detection precision while minimizing device complexity

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

This approach allows for rapid, controlled endometrial ablation with reduced risk of adjacent organ injury by ensuring the uterine cavity is intact before energy delivery, improving treatment efficiency and safety.

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:

Implementation Method 2

endometrial ablation using radiofrequency current which is rapid, provides for controlled ablation depth

Methodology Applied

Scientific EffectRadiofrequency ablation:

Data Source

PatentUS11020045B2Systems and methods for evaluating the integrity of a uterine cavity

Publication Date: 2021.06.01 AXORA MEDICAL INC

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.