Uterine Cavity Integrity Testing by Transcervical CO2 Flow Monitoring
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Solution Overview
Problem
Existing endometrial ablation devices face issues such as slow treatment times, incomplete treatments, non-uniform ablation depths, and risk of injury to adjacent organs, particularly due to perforations in the uterine wall.
Innovation Solution
A method and system using a transcervically introduced probe to evaluate the integrity of the uterine cavity by monitoring fluid flow, enabling controlled radiofrequency ablation with a capacitive coupling mechanism through an expandable thin-wall dielectric member containing ionized gas, which allows for rapid and uniform tissue ablation while minimizing organ damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If radiofrequency ablation is performed using conventional electrode designs, then treatment can be provided, but treatment times are relatively slow and ablation depths are non-uniform
Solution Approach 1:
The balloon electrode is designed to be expandable and inflatable, transitioning from a collapsed state during insertion to an expanded state during treatment. This dynamic configuration allows the electrode surface to conform to the uterine cavity shape, ensuring uniform contact and consistent ablation depth across the treatment area, while enabling rapid deployment and treatment delivery.
Solution Approach 2:
The system controls ablation parameters including radiofrequency power levels, balloon inflation pressure, and treatment duration to achieve uniform ablation depths. By adjusting these parameters and maintaining them within optimized ranges, the system ensures consistent energy delivery across the entire electrode surface, producing uniform ablation while maintaining efficient treatment times.
2Reliability
If radiofrequency current is applied directly to tissue, then ablation can be achieved, but there is risk of injury to adjacent organs due to perforation
Solution Approach 1:
A dielectric barrier (such as a thin-walled balloon or insulating layer) is introduced as an intermediary between the radiofrequency electrode and the uterine tissue. This dielectric layer allows capacitive coupling of radiofrequency energy to the tissue while providing a safety buffer that prevents direct contact and potential perforation, thereby reducing the risk of injury to adjacent organs while maintaining effective ablation capability.
Solution Approach 2:
The system incorporates safety features including balloon pressure monitoring, radiofrequency power control, and dielectric barriers that provide beforehand cushioning against potential tissue perforation. These preventive measures are built into the system design to cushion against excessive energy delivery or mechanical trauma before they can cause damage to adjacent organs.
3Reliability
If endometrial ablation is performed, then treatment of menorrhagia can be achieved, but incomplete treatments may occur
Solution Approach 1:
The balloon electrode is designed to provide complete coverage of the uterine cavity through its expandable structure, ensuring that all areas of the endometrium are treated uniformly. The balloon can be inflated to contact the entire cavity surface, and the radiofrequency energy is distributed across the entire electrode surface, ensuring complete and uniform ablation treatment without missing areas.
4Device complexity
If conventional ablation devices are used, then treatment can be provided, but device complexity and risk of perforation increase
Solution Approach 1:
The system employs a thin-walled balloon or flexible dielectric membrane as the electrode structure. This thin-film approach provides adequate insulation and safety against perforation while maintaining structural simplicity and flexibility for easy insertion and deployment. The thin-walled design reduces device complexity compared to rigid multi-component systems while maintaining safety through the dielectric barrier.
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 ensures rapid and uniform ablation depths with reduced risk of adjacent organ injury by characterizing uterine cavity integrity and enabling controlled radiofrequency ablation using capacitive coupling, ensuring effective treatment without perforation.
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
Implementation Method 2
applying radiofrequency current to endometrial tissue by means of capacitively coupling the current through an expandable, thin-wall dielectric member enclosing an ionized gas
Implementation Method 3
applying radiofrequency current to endometrial tissue by means of capacitively coupling the current through an expandable, thin-wall dielectric member enclosing an ionized gas
Implementation Method 4
expandable, thin-wall dielectric member enclosing an ionized gas
Implementation Method 5
applying radiofrequency current to endometrial tissue
Data Source
AI summary
Methods, systems and devices for evaluating the integrity of a uterine cavity. A method comprises introducing transcervically a probe into a patient's uterine cavity, 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.