Dielectric Balloon Endometrial Ablation Vapor Management

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Solution Overview

Problem

Existing endometrial ablation methods using radiofrequency current face challenges such as slow treatment times, incomplete ablation, non-uniform depths, and risk of injury to adjacent organs, due to inefficiencies in energy transfer and vapor accumulation in the uterine cavity.

Innovation Solution

The method involves expanding a thin-wall dielectric structure within the uterus to apply radiofrequency energy through inductive coupling, with a vapor release mechanism that opens at a preselected pressure to prevent vapor accumulation, ensuring efficient energy transfer and minimizing tissue damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If radiofrequency ablation is applied using conventional electrodes, then endometrial tissue can be ablated, but treatment time is prolonged and ablation uniformity is poor

Engineering Contradiction:
Improvetreatment timeVSAvoidablation uniformity
Core Design Contradiction:
ProductivityVSManufacturing precision

Solution Approach 1:

A dielectric balloon is introduced as an intermediary medium between the RF electrode and the endometrial tissue. The balloon is filled with a dielectric fluid that allows capacitive coupling of RF energy to the tissue, enabling more uniform and faster ablation compared to direct electrode contact methods

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

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

Engineering Contradiction:
Improveablation speedVSAvoidrisk of organ injury
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The dielectric balloon provides localized energy delivery by conforming to the uterine cavity shape and distributing RF energy uniformly across the endometrial surface. This localized and controlled energy delivery accelerates ablation while minimizing thermal spread to adjacent organs through the dielectric barrier

Inventive Principle:
Principle #3Local quality

3Loss of energy

If vapor is not released during ablation, then energy transfer efficiency decreases, but system complexity increases with vapor management

Engineering Contradiction:
Improveenergy transfer efficiencyVSAvoidvapor management system
Core Design Contradiction:
Loss of energyVSDevice complexity

Solution Approach 1:

Vapor extraction ports are incorporated into the dielectric balloon to actively remove vapor generated during RF ablation. This extraction mechanism prevents vapor accumulation that would insulate the tissue and reduce energy transfer efficiency, while integrating the function into the existing balloon structure rather than adding separate complex systems

Inventive Principle:
Principle #2Taking out (Extraction)

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 allows for rapid, controlled, and uniform endometrial ablation with reduced risk of organ injury by efficiently managing vapor pressure and enhancing energy delivery across the uterine wall.

Implementation Method 1

applying energy across the wall of the structure into the uterine wall

Methodology Applied
Scientific EffectInductive coupling: Electromagnetic Induction

Implementation Method 2

applying radiofrequency energy through inductive coupling

Methodology Applied
Scientific EffectRadiofrequency heating: Dielectric Heating

Implementation Method 3

releasing can be effected by inflating a barrier in a vapor release path between the uterine cavity and an exterior where the barrier is inflated at the desired release pressure

Methodology Applied
Scientific EffectPressure-driven flow: Pressure Gradient

Implementation Method 4

generating a plasma in a low pressure gas within the structure and inductively coupling the energy across the dielectric wall

Methodology Applied
Scientific EffectPlasma generation: Plasma

Implementation Method 5

inductively coupling the energy across the dielectric wall

Methodology Applied
Scientific EffectInductive coupling: Electromagnetic Induction

Implementation Method 6

The exterior surface conforms to an inner wall of the uterus

Methodology Applied
Scientific EffectElastic expansion: Elasticity

Data Source

PatentUS10456194B2System and method for endometrial ablation
Publication Date: 2019.10.29 AXORA MEDICAL INC
  • US10456194B2 patent drawing
  • US10456194B2 patent drawing
  • US10456194B2 patent drawing

AI summary

A wall of a uterus is ablated by expanding a structure in the uterus and applying energy across the wall of the structure into the uterine wall. An exterior surface of the structure conforms to an inner wall of the uterus, and the energy may cause vapor to collect between the wall and the structure. The vapor is released by providing a barrier to release which is inflated at a pressure above which the barrier at least partially collapses to allow the vapor to leave the uterus.