Single-Applicator Sinus Access With Dynamic Pullwire Deflection
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Solution Overview
Problem
Current treatments for nasal, otic, and throat conditions face challenges with poor patient compliance and efficacy due to difficulties in delivering drugs to distal sinus and ear anatomies, and minimally invasive systems lack improved ergonomics and the ability to treat multiple sinuses with a single device while minimizing therapeutic agent loss.
Innovation Solution
A single pullwire system with an integrated applicator allows adjustable deflection angles for accessing multiple target tissue sites, including paranasal sinuses, nose, ear, and throat, using a fixed handle orientation, and includes features to minimize drug loss during deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a single applicator is used to access multiple target tissue sites, then device complexity is reduced, but the applicator must achieve multiple deflection angles which increases operational complexity
Solution Approach 1:
The applicator incorporates a dynamic deflection mechanism that allows the distal end to bend to different angles (e.g., 0 degrees, 45 degrees, 90 degrees) relative to the longitudinal axis. This is achieved through a pullwire system where pulling the wire causes the distal end to deflect, enabling a single applicator to access multiple target tissue sites including paranasal sinuses, nose, ear, and throat with varying anatomical orientations
2Ease of operation
If minimally invasive systems are used to reduce patient trauma, then patient compliance improves, but the systems lack improved ergonomics and ability to treat multiple sinuses with a single device
Solution Approach 1:
The system integrates multiple functions into a single handheld device: the applicator can deflect to multiple angles to access different paranasal sinuses (frontal, maxillary, sphenoid), deliver therapeutic agents via balloon catheter, and perform tissue dilation. The system includes an integrated handle with controls for deflection, balloon inflation, and device deployment, allowing one device to treat multiple sinuses and conditions
3Quantity of substance
If balloon catheter is used to deliver therapeutic agent, then drug delivery capability is improved, but therapeutic agent loss during balloon deployment occurs
Solution Approach 1:
The balloon catheter is nested within the applicator in a configuration where the balloon is positioned inside the applicator lumen. The balloon can be inflated with therapeutic agent directly at the target site, and the applicator structure contains the balloon during deployment, minimizing agent loss. The system includes features to retain the therapeutic agent within the balloon until deployment is complete
Data Source
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AI summary
This application is generally related to systems and methods for accessing the paranasal sinuses and other passages of the nose, ear, and throat. The systems and methods generally employ devices capable of maintaining a fixed handle orientation with respect to the patient while generating the appropriate applicator deflection angle required to rotationally align or orient the applicator tip to the intended target tissue/anatomy for treatment. Methods are also described for deploying drug delivery devices within these body structures using the systems to treat medical conditions associated therewith.