Uterine Ablation Device Balloon Positioning and Vapor Delivery
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Solution Overview
Problem
Current endometrial ablation techniques, such as those using radio-frequency electrical current or heated fluid, often result in patient morbidity and mortality, and there is a need for a more effective and safer method for treating menorrhagia and other uterine diseases.
Innovation Solution
A uterine ablation device that delivers heated vapor to the uterus, utilizing a shaft with vapor delivery and return ports, a distal anchor, central and proximal balloons, and a cervical collar to position and seal the device within the uterus, ensuring effective tissue ablation while preventing vapor leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If radio-frequency electrical current or heated fluid is used for endometrial ablation, then tissue ablation is achieved, but patient morbidity and mortality increase
Solution Approach 1:
The patent changes the physical state and temperature parameters of the ablation medium. Instead of using high-temperature steam (which caused morbidity and mortality), the invention uses heated fluid at controlled temperatures (typically 40-45°C) that is safe for uterine tissue ablation while avoiding the harmful effects of excessive heat.
Solution Approach 2:
The patent introduces a contained fluid as an intermediary medium to transfer thermal energy to the endometrial tissue. This fluid acts as a safe mediator that can be precisely controlled in temperature and flow rate, replacing the direct application of high-temperature steam that caused patient harm.
2Reliability
If steam is used to treat uterine hemorrhage, then tissue ablation is achieved, but patient morbidity and mortality increase
Solution Approach 1:
The patent fundamentally changes the temperature parameter of the ablation medium from high-temperature steam (100°C or higher) to controlled-temperature heated fluid (40-45°C). This parameter change maintains tissue ablation effectiveness while eliminating the thermal damage that caused patient morbidity and mortality in historical steam treatments.
Solution Approach 2:
The patent converts the historical harm caused by uncontrolled high-temperature steam into a benefit by using precisely controlled heated fluid. The thermal energy that previously caused patient death is now harnessed at safe temperatures to achieve effective tissue ablation without harmful side effects.
3Measurement precision
If multiple balloons and anchors are used to position the device, then vapor delivery precision is improved, but device complexity increases
Solution Approach 1:
The patent divides the positioning function into multiple independent components: a distal anchor for securing the device tip, a central balloon for positioning within the uterus, and a proximal balloon for additional stabilization. Each component performs a specific positioning function, allowing precise vapor delivery while maintaining modular simplicity.
Solution Approach 2:
The device is inserted with all positioning components (anchors and balloons) in place before vapor delivery begins. The distal anchor is deployed first to secure the device, followed by inflation of the central and proximal balloons to establish precise positioning. This preliminary positioning action ensures accurate vapor delivery without requiring complex real-time adjustments during treatment.
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 method and device provide a safe and effective means to ablate uterine tissue, reducing patient morbidity and mortality while offering an alternative to hysterectomy for treating menorrhagia and other uterine diseases.
Implementation Method 1
delivering a heated vapor to the uterus to ablate uterine tissue
Implementation Method 2
inflating a proximal balloon of the uterine ablation device to push the uterine ablation device distally and place the distal anchor against an internal os
Data Source
AI summary
A method and system of providing therapy to a patient's uterus. The method can include the steps of inserting a uterine ablation device into the uterus, expanding a distal anchor, inflating a proximal balloon to pull the distal anchor proximally and seat the distal anchor against the internal os of the uterus, inflating a central balloon to seal the cervix, delivering vapor from the uterine ablation device into the uterus, and condensing the vapor on tissue within the uterus. The system can include a cervical collar adapted to place a distal portion of the device within the uterus when the cervical collar contacts an external os of the cervix.