Expandable RF Balloon for Uniform Endometrial Ablation
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Solution Overview
Problem
Existing endometrial ablation methods using radiofrequency current face challenges such as slow treatment times, incomplete treatments, non-uniform ablation depths, and risk of injury to adjacent organs.
Innovation Solution
A system and method involving an expandable RF energy delivery surface with a sealing structure for positioning in the uterine cavity, using an elongated introducer with a deployable frame and inflatable seal to ensure precise delivery of RF energy, minimizing the risk of organ injury and achieving uniform ablation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If conventional radiofrequency ablation devices are used, then endometrial ablation can be performed, but treatment time is slow and productivity is low
Solution Approach 1:
The balloon electrode is designed to be expandable and collapsible. When collapsed, it can be inserted through the cervical canal into the uterine cavity. Once positioned, it is expanded to contact the endometrial tissue, enabling rapid ablation. After treatment, it is collapsed and removed. This dynamic transformation allows the device to efficiently perform ablation while minimizing insertion and removal time.
Solution Approach 2:
The balloon electrode uses gas or liquid inflation to expand within the uterine cavity. This pneumatic/hydraulic mechanism allows rapid deployment of the ablation surface against the endometrium, significantly reducing the time required to establish effective treatment contact compared to manual positioning of solid electrodes.
2Manufacturing precision
If prior electrode designs are used, then ablation can be performed, but ablation depth is non-uniform and manufacturing precision is poor
Solution Approach 1:
The balloon electrode employs a flexible thin-walled structure that can conform to the irregular surface of the uterine cavity. This flexibility ensures uniform contact between the electrode surface and the endometrial tissue, creating consistent ablation depth across the treatment area. The thin wall allows effective RF energy transmission while maintaining conformal contact.
Solution Approach 2:
The balloon electrode adopts a spherical or dome-shaped geometry when expanded, which naturally conforms to the curved surface of the uterine cavity. This spherical configuration ensures that the electrode surface maintains relatively uniform distance from the target tissue, promoting uniform ablation depth and energy distribution across the treatment field.
3Object-affected harmful factors
If radiofrequency ablation is performed without proper sealing, then treatment can proceed, but risk of injury to adjacent organs increases
Solution Approach 1:
The balloon electrode acts as an intermediary barrier between the RF energy source and the surrounding tissues. By inflating the balloon to contact the endometrium, it confines the RF energy delivery to the intended target area, preventing energy leakage that could injure adjacent organs such as the bowel or bladder. The balloon wall serves as a controlled interface for energy transmission.
Solution Approach 2:
The cervical sealing structure extracts and isolates the treatment zone by sealing the cervical canal. This creates a closed system within the uterine cavity, ensuring that RF energy and any generated fluids or vapor remain confined to the treatment area and cannot escape to damage surrounding structures. The seal effectively removes the risk pathway to adjacent organs.
4Reliability
If incomplete ablation treatments are performed, then treatment time is reduced, but treatment reliability is poor
Solution Approach 1:
The balloon electrode is designed with a large surface area that can simultaneously treat multiple regions of the endometrium. The balloon can be positioned to contact the fundus and extend down the uterine cavity, enabling global ablation in a single application. This multi-functional coverage ensures complete treatment of the entire endometrial surface without requiring multiple sequential interventions.
Solution Approach 2:
The balloon electrode maintains continuous contact with the endometrial tissue during RF energy delivery. This continuous contact ensures uninterrupted energy transmission across the entire treatment field, preventing areas of incomplete ablation. The sustained contact and continuous energy application guarantee thorough treatment while maintaining efficient single-stage 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 system enables rapid, controlled endometrial ablation with reduced risk of injury to adjacent organs, achieving uniform tissue effects and efficient treatment.
Implementation Method 1
capacitively coupling the current through an expandable, thin-wall dielectric member enclosing an ionized gas
Implementation Method 2
applying radiofrequency current to endometrial tissue by means of capacitively coupling the current through an expandable, thin-wall dielectric member enclosing an ionized gas
Implementation Method 3
The RF current heats the tissue to a temperature sufficient to ablate the tissue
Implementation Method 4
The RF current heats the tissue to a temperature sufficient to ablate the tissue
Implementation Method 5
The RF current heats the tissue to a temperature sufficient to ablate the tissue
Implementation Method 6
a flow of a gas is provided through the probe into the dielectric structure to expand the dielectric structure
Data Source
AI summary
A system for treating uterine tissue comprises an elongated introducer with a working end configured for endometrial ablation. The working end includes an expandable seal for positioning in a patient's cervical canal and an actuator pump mechanism carried by a proximal handle coupled to the introducer for expanding the seal. The handle optionally includes a mechanism for simultaneously expanding the seal and deploying a treatment element on the working end of the introducer.