Uterine Integrity Testing via Fluid Pressure Monitoring
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Solution Overview
Problem
Current endometrial ablation procedures without hysteroscopic visualization face challenges in verifying uterine cavity integrity, as perforations may not be readily detectable, leading to potential complications and the need for more invasive methods to ensure proper device placement and function.
Innovation Solution
A real-time fluid flow rate control system is implemented, allowing for increased fluid flow to clear clogs during patency testing, and a pressurized fluid reservoir within the uterine insertion device, eliminating the need for external height measurements and accessory components, to enhance the accuracy and efficiency of uterine integrity and patency tests.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If hysteroscopy is used to verify uterine cavity integrity, then detection accuracy improves, but procedure complexity and time increase
Solution Approach 1:
The patent extracts the integrity verification function from the complex hysteroscopic procedure by implementing a separate, dedicated integrity test system that uses fluid pressure monitoring to detect perforations independently of visual inspection
Solution Approach 2:
The patent introduces fluid pressure as an intermediary medium to detect uterine cavity integrity. By monitoring pressure changes during fluid infusion, the system can detect perforations without requiring direct visual inspection through hysteroscopy
2Reliability
If fluid flow rate is increased to clear clogs during patency testing, then testing reliability improves, but risk of tissue damage increases
Solution Approach 1:
The patent implements dynamic fluid flow rate control that adjusts the infusion rate based on real-time pressure feedback. The system can temporarily increase flow rate to clear clogs during patency testing, then immediately reduce it to safe levels, thereby maintaining testing reliability while minimizing tissue damage risk
Solution Approach 2:
The patent uses pressure feedback from the uterine cavity to regulate fluid flow rate. When pressure exceeds safe thresholds, the system automatically reduces flow rate to prevent tissue damage, while still allowing sufficient flow to clear clogs when needed
3Measurement precision
If external height measurements and accessory components are used for fluid reservoir positioning, then fluid delivery accuracy improves, but device complexity increases
Solution Approach 1:
The patent implements a self-regulating pressurized fluid reservoir system that maintains accurate fluid delivery without requiring external height measurements or additional accessory components. The system uses internal pressure regulation mechanisms to ensure consistent fluid delivery to the uterine cavity
Solution Approach 2:
The patent integrates multiple functions into the pressurized fluid reservoir, combining fluid storage, pressure regulation, and delivery control in a single component, thereby eliminating the need for separate height measurement devices and accessory components
4Measurement precision
If device removal and reinsertion is performed to clear clogs, then patency testing accuracy improves, but procedure time and patient discomfort increase
Solution Approach 1:
The patent performs preliminary patency testing with controlled fluid flow before proceeding with the main procedure. By using dynamic flow rate adjustment to clear clogs in situ during the initial testing phase, the system ensures accurate patency verification without requiring subsequent device removal and reinsertion
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 reduces procedure time, minimizes patient discomfort, and eliminates the need for device removal and reinsertion, providing a more robust and accurate integrity and patency testing system.
Implementation Method 1
pressurizing the fluid in the reservoir with a pressure source acting through a pressure regulator to deliver fluid from the reservoir of the uterine ablation device into the uterus
Implementation Method 2
A real-time fluid flow rate control system is implemented, allowing for increased fluid flow to clear clogs during patency testing
Implementation Method 3
monitoring the fluid level of the fluid in the reservoir with one or more sensors of the reservoir
Data Source
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. Systems for performing these methods with monitored flow rate and independent of patient height relative to the pressure source are also disclosed.