Endometrial Ablation Device Integrity Testing
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Solution Overview
Problem
Current endometrial ablation techniques without hysteroscopic visualization rely heavily on physician manipulation, leading to inconsistent device placement and increased risk of adverse events due to the inability to assess proper placement and sealing within the uterine cavity, which can result in incomplete or ineffective procedures.
Innovation Solution
A method and system utilizing heated vapor with a uterine ablation device equipped with balloons and a control system for integrity and patency testing, ensuring proper placement and sealing by monitoring pressure and flow rates, and automatically terminating vapor delivery if temperature thresholds are exceeded, thereby enhancing procedural safety and consistency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If blind endometrial ablation techniques are used without hysteroscopic visualization, then the procedure is simplified and can be performed without concurrent visualization equipment, but the physician cannot verify proper device placement and sealing within the uterine cavity, leading to inconsistent placement and increased risk of perforation
Solution Approach 1:
The patent implements a feedback mechanism by introducing a distension media (gas or fluid) into the uterine cavity and monitoring pressure changes to provide real-time information about device placement and uterine cavity integrity. The pressure sensor feedback allows the physician to verify proper balloon positioning and detect perforations without requiring hysteroscopic visualization during the procedure.
Solution Approach 2:
The patent uses distension media (gas or fluid) as an intermediary substance to transmit information about device placement and uterine cavity status. The media fills the space between the balloons and uterine walls, and pressure changes in this media provide indirect but reliable information about proper device positioning and sealing without requiring direct visual observation.
2Device complexity
If physician tactile manipulation is used for device placement, then the procedure can be performed without complex visualization systems, but the placement consistency depends on physician skill and experience, leading to variable procedural outcomes
Solution Approach 1:
The pressure monitoring system provides objective feedback that reduces dependence on physician tactile skill. The pressure sensor continuously monitors the uterine cavity pressure, providing quantifiable data that guides device placement and confirms proper positioning, thereby standardizing the procedure across different operators.
Solution Approach 2:
The patent replaces reliance on physician tactile sensation and manual manipulation skills with an automated pressure sensing system. The mechanical pressure sensor objectively detects device placement accuracy, substituting the subjective tactile feedback that varies with physician experience.
3Loss of time
If no integrity testing is performed, then the procedure time is reduced and the workflow is simplified, but the risk of undetected perforations and adverse events increases
Solution Approach 1:
The patent performs integrity testing as a preliminary action before completing the ablation procedure. The distension media is introduced and pressure monitoring is performed during the procedure to verify uterine cavity integrity before finalizing treatment, preventing undetected perforations without significantly extending total procedure time.
Solution Approach 2:
The pressure monitoring and integrity testing are performed continuously throughout the ablation procedure rather than as a separate discrete step. The distension media remains in place and pressure is continuously monitored, providing ongoing verification of uterine integrity without interrupting the therapeutic vapor delivery.
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 accurate device placement and sealing within the uterine cavity, reducing the risk of perforation and improving the consistency and safety of endometrial ablation procedures by providing real-time feedback and automatic termination of vapor delivery to prevent overheating.
Implementation Method 1
uses radio-frequency electrical current (RF current) to remove or coagulate the endometrial tissue
Implementation Method 2
uses radio-frequency electrical current (RF current) to remove or coagulate the endometrial tissue
Implementation Method 3
A method and system utilizing heated vapor with a uterine ablation device equipped with balloons and a control system for integrity and patency testing
Implementation Method 4
ensuring proper placement and sealing by monitoring pressure and flow rates
Implementation Method 5
automatically terminating vapor delivery if temperature thresholds are exceeded, thereby enhancing procedural safety and consistency
Data Source
Figure 1A
Figure 1B
Figure 1C
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.