Eustachian Tube Balloon Catheter Depth Marking for Precise Dilation
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Solution Overview
Problem
Existing methods for dilating the Eustachian tube face challenges in accessing and preserving the integrity of the tympanic membrane and middle ear structures, particularly when anatomical constraints or skill limitations hinder the use of conventional instruments.
Innovation Solution
A guidewire with an inflatable balloon and navigation sensor is used to access the Eustachian tube through the middle ear, featuring depth indicia markers and a surgical navigation system for precise positioning, allowing dilation without compromising the tympanic membrane.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional instruments are used to access the Eustachian tube, then the procedure can be performed, but the integrity of the tympanic membrane and middle ear structures is compromised
Solution Approach 1:
The instrument is divided into distinct functional segments: a guidewire for navigation, an inflatable balloon for dilation, and depth indicia for positioning. This segmentation allows each component to perform its specific function while minimizing overall trauma to the tympanic membrane and middle ear structures.
Solution Approach 2:
The guidewire acts as an intermediary element that facilitates access to the Eustachian tube through the tympanic membrane while preserving its integrity. The wire provides a stable pathway for the balloon catheter without requiring direct manipulation of the delicate middle ear structures.
2Measurement precision
If depth indicia are added to the guidewire, then positioning precision is improved, but device complexity increases
Solution Approach 1:
Depth indicia are provided as visual markers (such as colored bands or contrasting patterns) on the guidewire that indicate specific depths or positions. This allows the operator to precisely position the balloon catheter without complex electronic systems, maintaining simplicity while improving measurement precision.
3Productivity
If the balloon is inflated to dilate the Eustachian tube, then pressure equalization is achieved, but trauma to the tympanic membrane increases
Solution Approach 1:
The guidewire is first advanced through the tympanic membrane to the Eustachian tube under visual guidance before the balloon is inflated. This preliminary positioning ensures that the balloon will be correctly placed in the Eustachian tube rather than on the tympanic membrane, preventing trauma while enabling effective dilation for pressure equalization.
Solution Approach 2:
Visual feedback from the surgical microscope allows the operator to monitor the position of the guidewire and balloon in real-time. This feedback mechanism enables precise control during inflation, ensuring the balloon dilates the Eustachian tube without exerting harmful forces on the tympanic membrane.
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 safe and precise dilation of the Eustachian tube while minimizing trauma, facilitating effective pressure equalization and reducing the risk of infection.
Implementation Method 1
a dilator secured on the distal body end portion and configured to expand from a contracted state to an expanded state
Data Source
AI summary
A surgical system and method are used to position a guidewire within an anatomical passageway includes the guidewire, a dilator, a reference feature, and a marker. The guidewire has a guidewire body extending to a distal body end portion. The dilator is secured on the distal body end portion and configured to expand from a contracted state to an expanded state. The dilator in the contracted state is configured to pass through an isthmus of a Eustachian tube. The dilator in the expanded state is configured to dilate the Eustachian tube. The reference feature secured relative to the guidewire, and the marker is positioned on the guidewire a predetermined distance from the reference feature. Thereby, the marker is configured to indicate the predetermined distance to an operator for determining a depth of the reference feature in the anatomical passageway.