Uterine Ablation Device Integrity Verification
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Solution Overview
Problem
Current endometrial ablation techniques without hysteroscopic visualization lack effective methods to verify uterine cavity integrity, risking perforations and unintended injuries, as perforations may not be readily detectable even under direct vision.
Innovation Solution
A uterine ablation device equipped with a system for performing integrity and patency tests using a heated vapor, which includes a shaft with vapor ports, balloons for positioning, and flow meters to assess the uterine cavity's sealing and flow integrity, ensuring proper device placement and preventing perforations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If hysteroscopic visualization is used during endometrial ablation, then procedural accuracy and safety are improved, but device complexity and procedure time increase
Solution Approach 1:
The patent performs integrity and patency tests before the actual endometrial ablation procedure to verify uterine cavity integrity and device placement. This preliminary verification action ensures safety without requiring continuous hysteroscopic visualization during the ablation itself, thus reducing procedural complexity while maintaining reliability
Solution Approach 2:
The patent introduces flow meters and pressure sensors as intermediary measurement devices to assess uterine cavity integrity indirectly, rather than relying on direct visual inspection. These intermediary tools provide reliable safety verification through quantitative measurements of fluid flow and pressure, eliminating the need for complex real-time hysteroscopic monitoring
2Reliability
If integrity tests are performed to verify uterine cavity integrity, then procedural safety is improved, but procedure time increases
Solution Approach 1:
The patent integrates integrity and patency tests into the existing device insertion and positioning sequence, performing these verification actions continuously as part of the standard workflow rather than as separate discrete steps. The flow meters and pressure sensors operate simultaneously with device positioning, ensuring safety verification does not add net time to the procedure
Solution Approach 2:
The device performs self-verification through automated flow meter readings and pressure sensor measurements that continuously monitor integrity and patency without requiring additional manual intervention or separate test procedures. The system serves its own verification needs using integrated sensors and display mechanisms, eliminating time-consuming manual testing
3Measurement precision
If flow meters are used to measure fluid flow for integrity testing, then measurement precision is improved, but device complexity increases
Solution Approach 1:
The patent employs flow meters and pressure sensors that serve multiple functions: they measure fluid flow during integrity tests, monitor pressure during patency tests, and provide real-time feedback during the entire ablation procedure. This multi-functionality justifies the added device complexity by delivering precise measurements across multiple operational phases without requiring separate specialized instruments
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 device effectively verifies uterine cavity integrity and proper device placement, reducing the risk of perforations and enhancing safety during 'blind' endometrial ablation procedures by stabilizing flow meter readings and ensuring accurate flow rates, thus improving procedural accuracy and patient safety.
Implementation Method 1
detect with the at least one flow meter an integrity flow rate of gas or fluid as it is delivered into the uterus
Implementation Method 2
pressure regulator configured to regulate a pressure of the gas or fluid from the gas source
Data Source
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AI summary
A method and system of providing therapy to a patient's uterus is provided, which can include any number of features. The method can include the steps of inserting a uterine device into the uterus and performing a uterine integrity test to determine that the uterus is intact and not perforated. If it is determined that the uterus is not perforated, a patency test can be performed to determine that the uterine device is not clogged or embedded in tissue. If the uterus is intact and the device is not clogged or embedded in tissue, the uterus can be treated with the uterine device, e.g., uterine ablation. Systems for performing these methods are also disclosed.