Endometrial Ablation System with Gas Flow Integrity Testing
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Solution Overview
Problem
Existing endometrial ablation systems face challenges such as difficulty in expanding energy applicators within the uterus, excessive heat transfer to vaginal tissues, and limited visibility during insertion, which complicates the procedure and increases the risk of injury to adjacent organs.
Innovation Solution
The system includes an elongated shaft with a distal energy applicator that can be actuated between non-expanded and expanded shapes, featuring a handle with movable grips and springs for easy expansion within the uterus, along with a thermally insulating sleeve and a mechanism for uterine cavity integrity testing using gas flow to prevent perforations, allowing for controlled ablation and reduced heat transfer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an energy applicator is expanded within the uterus for endometrial ablation, then ablation effectiveness is improved, but the risk of uterine wall perforation increases
Solution Approach 1:
The system performs a gas flow test through the expanded applicator before delivering RF energy to verify uterine cavity integrity. This preliminary action detects potential perforations or misplaced applicators, allowing the physician to reposition or discard the applicator before ablation, thereby preventing harmful effects while maintaining ablation effectiveness
Solution Approach 2:
The system uses gas flow sensors to provide real-time feedback on uterine cavity integrity after applicator expansion. The controller monitors gas flow parameters and alerts the physician to abnormal conditions, enabling immediate corrective action before energy delivery, thus resolving the contradiction between effective ablation and perforation risk
2Reliability
If radiofrequency energy is applied to ablate uterine tissue, then treatment efficacy is improved, but heat transfer to vaginal tissues increases
Solution Approach 1:
The system introduces a gas flow intermediary between the RF energy source and vaginal tissues. The gas acts as a thermal barrier that absorbs and dissipates heat away from the vaginal wall while allowing RF energy to effectively ablate the endometrium, thus resolving the contradiction between treatment efficacy and heat transfer to adjacent tissues
3Ease of operation
If the energy applicator is inserted into the uterus, then ablation treatment can be performed, but visibility during insertion is limited
Solution Approach 1:
The energy applicator is designed with multi-functionality, integrating both RF ablation capability and gas flow testing functionality into a single device. This allows the same applicator to be used for both treatment and safety verification, eliminating the need for separate instruments and simplifying the overall procedure while maintaining visibility and control
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 enables rapid, controlled uterine tissue ablation with reduced risk of heat transfer to non-target tissues and improved visibility, facilitating safer procedures by ensuring uterine cavity integrity before ablation.
Implementation Method 1
providing a flow of gas through the energy applicator to a patient's uterine cavity... monitoring at least one parameter of the gas flow to determine whether there is a perforation in a wall of the patient's uterine cavity
Implementation Method 2
delivering a pressurized flow of a liquid medium which carries a radiofrequency current to tissue... radiofrequency ablation devices have been proposed
Data Source
AI summary
A system for treating uterine tissue comprises an elongated shaft having a proximal end, a distal end, and a longitudinal axis extending between said proximal and distal ends. An energy applicator at the distal end of the elongated shaft is actuatable between a non-expanded shape to be inserted through a patient's cervical canal and an expanded shape to conform to the walls of the patient's uterus. A handle is coupled to a proximal end of the elongated shaft. The handle may include first and second moveable grips coupled to actuate the energy applicator with an upper spring and a lower spring disposed to urge the first and second moveable grips to move apart. An inflatable seal may be located at a distal end of the elongated shaft with a thermally insulating sleeve disposed over the elongated shaft proximal to the inflatable seal. An extension member may be coupled to axially advance and retract the extension member and have a central passage to removably receive an endoscope to enable viewing through the transparent portion of the energy applicator. Alternatively, a tubular sheath may be coupled to the elongated shaft to removably receive an endoscope to enable forward viewing from a location near the distal end of the energy applicator.