Expandable Dielectric Balloon for Uniform Endometrial Ablation

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Solution Overview

Problem

Existing endometrial ablation technologies face challenges such as slow treatment times, incomplete ablation, non-uniform ablation depths, and risk of injury to adjacent organs during radiofrequency current application for menorrhagia treatment.

Innovation Solution

An electrosurgical system utilizing an expandable thin-wall dielectric member that capacitively couples radiofrequency current through an ionized gas, allowing for controlled and uniform ablation depths while minimizing the risk of organ injury, by deploying a dielectric structure within the uterine cavity and using a frame to expand the structure for effective tissue contact.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If traditional radiofrequency ablation devices are used, then treatment can be performed, but treatment time is slow and ablation depth is non-uniform

Engineering Contradiction:

Improvetreatment speedVSAvoidablation depth uniformity

Core Design Contradiction:

ProductivityVSManufacturing precision

Solution Approach 1:

The balloon electrode is designed to be expandable, transitioning from a compressed delivery state to an expanded treatment state. This dynamic expansion allows the electrode to conform to the uterine cavity shape, ensuring uniform contact and consistent ablation depth across the treatment area, while the rapid expansion capability enables faster treatment compared to traditional fixed electrodes

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The balloon electrode incorporates a non-uniform thickness design, with varying wall thickness in different regions. This allows different portions of the balloon to deliver different energy densities to corresponding regions of the endometrium, achieving uniform ablation depth despite variations in tissue characteristics and balloon curvature, thereby resolving the contradiction between treatment speed and ablation uniformity

Inventive Principle:

Principle #3Local quality

2Productivity

If higher energy is applied to speed up treatment, then treatment time decreases, but risk of injury to adjacent organs increases

Engineering Contradiction:

Improvetreatment speedVSAvoidrisk of organ injury

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

A dielectric material is introduced as an intermediary between the radiofrequency energy source and the endometrial tissue. This dielectric layer acts as a controlled barrier that allows rapid charging and discharging of energy, enabling short high-energy pulses that achieve quick ablation while the dielectric properties prevent uncontrolled energy transmission that could injure adjacent organs

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The ablation process uses periodic pulsed radiofrequency energy delivery through the dielectric-filled balloon. These controlled pulses allow for rapid energy deposition in the endometrium while providing intervals for heat dissipation and preventing thermal damage to deeper structures, thus achieving fast treatment without increasing organ injury risk

Inventive Principle:

Principle #19Periodic action

3Reliability

If incomplete ablation is avoided by increasing treatment intensity, then ablation completeness improves, but treatment time increases

Engineering Contradiction:

Improveablation completenessVSAvoidtreatment speed

Core Design Contradiction:

ReliabilityVSProductivity

Solution Approach 1:

The balloon electrode design provides universal coverage of the entire endometrial surface through its expandable nature. Once expanded, the balloon contacts all regions of the uterine cavity simultaneously, ensuring complete ablation coverage in a single treatment session. This eliminates the need for multiple passes or prolonged treatment times required by focal electrodes, achieving both completeness and speed

Inventive Principle:

Principle #6Universality (Multi-functionality)

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 and uniform endometrial ablation with controlled depth, reducing the risk of injury to adjacent organs and improving treatment efficiency.

Implementation Method 1

capacitively coupling the current through an expandable, thin-wall dielectric member enclosing an ionized gas

Methodology Applied

Scientific EffectCapacitive coupling: Capacitance

Implementation Method 2

applying radiofrequency current to endometrial tissue by means of capacitively coupling the current

Methodology Applied

Scientific EffectRadiofrequency heating: Dielectric Heating

Implementation Method 3

enclosing an ionized gas

Methodology Applied

Scientific EffectPlasma: Plasma

Data Source

PatentUS8956348B2Methods and systems for endometrial ablation

Publication Date: 2015.02.17 AXORA MEDICAL INC

AI summary

Methods, systems and devices for endometrial ablation. In accordance with a method, a working end of an RF ablation device is positioned in a patient uterus to contact endometrial tissue, the working end comprising a dielectric wall capable of non-expanded and expanded shapes. A Hall effect sensor carried by the working end is used to generate a signal that indicates a dimension of the uterine cavity or a frame-open parameter of the working end.