Iontophoretic Earplug with Flexible Sealing and Movable Electrode
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Solution Overview
Problem
Current iontophoresis devices for anesthetizing the tympanic membrane have limitations, including inability to administer anesthesia in an upright position and difficulty in sealing the ear canal, leading to inefficient drug delivery and discomfort, especially in children, as they often require reclining and tilting, and can only anesthetize one ear at a time.
Innovation Solution
The development of an iontophoresis system comprising an earplug with flexible sealing elements and a movable electrode device that conforms to the ear canal, allowing for bilateral simultaneous anesthesia in an upright position, featuring a side vent for pressure relief and a headset for maintaining the earplugs in place, ensuring a secure and efficient delivery of the anesthetizing drug.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional iontophoresis devices are used without earplug sealing, then the patient can maintain head movement freedom, but the drug solution leaks out of the ear canal making iontophoretic anesthesia delivery difficult or impossible
Solution Approach 1:
The earplug is inserted into the ear canal before administering the iontophoretic drug solution, creating a sealed environment in advance. This preliminary sealing action prevents fluid leakage during the procedure and eliminates the need for specific patient positioning, allowing the patient to remain upright and mobile throughout treatment.
2Productivity
If traditional iontophoresis devices are used, then the device structure is simple, but the procedure time is lengthy as only one ear can be anesthetized at a time
Solution Approach 1:
The system combines multiple earplugs (first earplug for left ear, second earplug for right ear) with a common fluid reservoir and control system into a single integrated apparatus. This merging allows simultaneous bilateral iontophoretic anesthesia delivery to both ears, reducing total procedure time while maintaining complete functional control through a unified system.
3Adaptability or versatility
If rigid earplug structures are used, then the manufacturing precision is high, but the adaptability to different ear canal curvatures is poor
Solution Approach 1:
The earplug incorporates a flexible membrane structure that can conform to the curved anatomy of the ear canal. This flexible shell design allows the earplug to adapt to individual patient anatomies while maintaining its sealing function, eliminating the need for high manufacturing precision rigid structures and improving universal applicability.
4Reliability
If the electrode is stationary within the earplug, then the device complexity is low, but the ability to maintain consistent electrode-solution contact is poor due to bubble formation
Solution Approach 1:
The electrode is designed to be movable within the earplug, capable of adjusting its position to maintain consistent contact with the iontophoretic drug solution. This dynamic adjustment mechanism allows the electrode to compensate for bubble formation and fluid level changes, ensuring reliable iontophoretic delivery without requiring overly complex control systems.
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 efficient and comfortable bilateral iontophoretic anesthesia of the tympanic membrane in an upright position, improving patient mobility and reducing procedure time, while preventing fluid leakage and bubble interference, thus enhancing the effectiveness of iontophoretic drug delivery.
Implementation Method 1
Iontophoresis is a method for delivering a drug across a biological membrane, such as the skin or, in the case of certain ear surgery procedures, the tympanic membrane (TM). By applying low-level electrical current to a similarly charged drug solution, iontophoresis repels ions of the drug, thus transporting them across the skin or other membrane.
Implementation Method 2
The flexible sealing element may be coupled to the tube of the earplug and may be shaped to form a seal within the ear canal
Data Source
AI summary
A system and method for use in iontophoretic anesthesia of a tympanic membrane are disclosed. The system generally includes an earplug and an electrode device. The earplug includes at least one sealing member for sealing the earplug in an ear canal. The sealing member includes microholes which vent fluid above a certain pressure threshold. A headset may connect the earplug to a second earplug. The method involves using the system on a human or animal subject.