Eustachian Tube Dilator Sleeve for Atraumatic Therapeutic Access
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Solution Overview
Problem
Existing medical procedures for treating Eustachian tube dysfunction, such as patulous and obstructive conditions, face challenges in effectively keeping the eustachian tube open and delivering therapeutic agents without causing mucosa injury.
Innovation Solution
A device with a dilating element and protective sleeve is used to trans-nasally insert and expand the eustachian tube, allowing for direct delivery of therapeutic means like drugs, laser energy, or suction, while minimizing mucosa contact and injury through a protective sleeve mechanism.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a dilating element is inserted to expand the eustachian tube, then the tube can be kept open for therapeutic interventions, but the dilating element may directly contact and irritate the mucosa walls causing injury
Solution Approach 1:
A protective sleeve is introduced as an intermediary component between the dilating element and the eustachian tube mucosa. The sleeve covers the dilating element during insertion and withdrawal, preventing direct contact with the mucosa walls. The sleeve can be retracted or removed once the dilating element is properly positioned and expanded, allowing the tube to remain open while protecting the mucosa from irritation and injury.
2Adaptability or versatility
If the eustachian tube is dilated to allow therapeutic means delivery, then access for laser energy or drugs is improved, but the tube structure must be significantly altered from its closed state
Solution Approach 1:
The dilating element is designed to be dynamically expandable and collapsible. In its collapsed state, it has a small profile that allows easy insertion through the nasal passage. Once positioned within the eustachian tube, the element expands to a larger diameter to dilate the tube and create access for therapeutic interventions. The dynamic nature allows the element to be collapsed again for safe removal, temporarily altering the tube shape only when needed for treatment.
3Ease of operation
If the dilating element is kept small for easy insertion, then ease of insertion is improved, but the element cannot effectively dilate the tube to maintain it open
Solution Approach 1:
The dilating element transitions from a compressed, low-profile state during insertion to an expanded, high-profile state during the procedure. This dynamic size change allows the element to be easily inserted in a small configuration while effectively dilating the eustachian tube when expanded, maintaining the tube open for therapeutic interventions.
Solution Approach 2:
The dilating element is nested within a delivery catheter or protective sleeve during insertion. This nesting allows the dilating element to be transported in a compact form that facilitates easy insertion through the nasal passage. Once positioned, the element is deployed from its nested state to expand and dilate the eustachian tube, achieving both ease of insertion and effective dilation.
Data Source
AI summary
There is provided a device for eustachian tube treatments having a handle section with proximal and distal ends where the handle section has a dilator control with at least first and second positions. The dilator control is connected to a plate internal to the handle section, which is connected to an internal shaft. An insertion tube is connected to the plate and extends from the distal end of the handle section. A protective sleeve is inside of the insertion tube and connected to the plate. A dilator is connected at a first end to the plate and collapsed within the protective sleeve, with the dilator expanding when moved to a position external to the distal end of the insertion tube and the protective sleeve is withdrawn back into the insertion tube. The dilator maintains the eustachian tube open for delivery of laser energy or therapeutics to a desired treatment area.