Iontophoresis Earplug Fluid Management for Tube Insertion

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Solution Overview

Problem

Current methods for inserting pressure equalization tubes into the tympanic membrane often require general anesthesia, which is resource-intensive and carries risks, and existing iontophoresis systems may not effectively manage fluid flow during procedures, leading to interruptions.

Innovation Solution

A pressure equalization tube delivery device (PETDD) that uses iontophoresis for local anesthesia and an earplug system with improved fluid management to maintain a fluid tight seal and tolerate volumetric changes in the ear canal, allowing for the insertion of pressure equalization tubes without general anesthesia.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If general anesthesia is used for pressure equalization tube insertion, then the procedure can be performed safely, but resource requirements increase and procedural risks increase

Engineering Contradiction:
Improveprocedural safetyVSAvoidresource requirements
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent extracts the anesthesia function from general anesthesia and implements it through local iontophoresis delivery. The iontophoresis device delivers local anesthetic directly to the tympanic membrane area, eliminating the need for general anesthesia while maintaining procedural safety and comfort.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent replaces the mechanical/general anesthesia system with an electrochemical iontophoresis system. The iontophoresis device uses electrical current to drive anesthetic ions through the skin, providing localized anesthesia without the complexity of general anesthesia administration.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Device complexity

If iontophoresis is used for local anesthesia, then resource requirements are reduced, but fluid flow management becomes problematic causing procedural interruptions

Engineering Contradiction:
Improveresource requirementsVSAvoidprocedural efficiency
Core Design Contradiction:
Device complexityVSProductivity

Solution Approach 1:

The patent introduces a fluid management system as an intermediary between the iontophoresis device and the patient's ear canal. This system includes fluid reservoirs, delivery channels, and drainage mechanisms that actively manage fluid flow during the procedure, preventing interruptions while maintaining the benefits of iontophoresis.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The iontophoresis device incorporates self-regulating fluid management features, including automatic fluid level sensing, controlled drainage pathways, and integrated reservoirs that maintain optimal fluid levels throughout the procedure without requiring external intervention.

Inventive Principle:
Principle #25Self-service

3Reliability

If a fluid tight seal is maintained in the ear canal, then iontophoresis effectiveness is improved, but volumetric changes in the ear canal cause fluid flow interruptions

Engineering Contradiction:
Improveiontophoresis effectivenessVSAvoidtolerance to volumetric changes
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent implements a dynamic fluid management system that adapts to volumetric changes in the ear canal. The system includes flexible sealing elements, adjustable fluid reservoirs, and controlled drainage pathways that automatically adjust to maintain the fluid tight seal necessary for effective iontophoresis while accommodating natural ear canal volume changes during the procedure.

Inventive Principle:
Principle #15Dynamics

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

Enables the safe and efficient insertion of pressure equalization tubes using local anesthesia, reducing resource requirements and minimizing procedural interruptions due to fluid flow management.

Implementation Method 1

Some pressure equalization tube delivery systems and methods provide a local anesthetic through iontophoresis

Methodology Applied
Scientific EffectIontophoresis: Iontophoresis

Implementation Method 2

maintain a fluid tight seal and tolerate volumetric changes in the ear canal

Methodology Applied
Scientific EffectFluid tight seal:

Data Source

PatentEP3322390B1Earplug for iontophoresis system
Publication Date: 2024.06.12 TUSKER MEDICAL INC
  • EP3322390B1 patent drawingFigure 1
  • EP3322390B1 patent drawingFigure 2~3
  • EP3322390B1 patent drawingFigure 4

AI summary

Systems, apparatus, and methods are disclosed for gripping and/or positioning a plug (320) in an ear canal outside a tympanic membrane, performing iontophoresis, and/or delivering a pressure equalization tube to the tympanic membrane, including a rigid body (323), an electrode (352), and/or a liner strip (380). The rigid body may define a channel (321), a vent path (329), and a reservoir (370) in fluid communication with the channel the vent path. The reservoir may be configured to increase the volume of the channel, thereby tolerating volumetric changes in the ear without exposing the electrode disposed within the channel to air. The electrode may define a longitudinal axis from which the reservoir extends laterally and proximally to increase a spacing between the electrode and the vent path. The liner strip may include a plurality of gripping portions and attachment portions to cover at least some of a pressure sensitive adhesive on the plug.