Steerable Medical Device for Airway Visualization
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Solution Overview
Problem
Conventional methods for diagnosing obstructive sleep apnea (OSA) are limited by the inability to visualize airway obstructions during natural sleep and the risks associated with artificially induced sleep studies, which can alter normal bodily functions and provide incomplete data on obstructions in different sleeping positions.
Innovation Solution
A medical device with an elongate member that can be advanced through the airway to define a curve, allowing for visualization and treatment by incorporating an imaging device and actuator to manipulate the device between straight and curved configurations, enabling visualization and treatment of airway obstructions without the need for induced sleep.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional sleep studies are performed during natural sleep, then the airway can be monitored without anesthesia risks, but visualization of airway obstructions is not performed
Solution Approach 1:
The patent combines monitoring capabilities with visualization capabilities into a single integrated device. The medical device includes both sensors for monitoring physiological parameters and an imaging device with light source and optical fibers for visualizing airway obstructions, allowing simultaneous acquisition of both functional and structural data during natural sleep.
Solution Approach 2:
The medical device performs multiple functions: it monitors respiratory parameters, visualizes airway obstructions through imaging, and can be positioned in different sleeping configurations. This multi-functional approach eliminates the need for separate natural sleep monitoring and artificial sleep endoscopy procedures.
2Difficulty of detecting and measuring
If artificially induced sleep studies are performed, then airway visualization can be achieved, but the use of anesthesia increases risks and may alter normal bodily functions
Solution Approach 1:
The device is designed to be introduced and positioned during wakeful states or mild sedation, with all imaging and monitoring components pre-assembled and tested before patient contact. The elongate member can be configured in advance to match expected airway anatomy, reducing the need for complex maneuvers under anesthesia.
Solution Approach 2:
The patent replaces the mechanical/anesthesia-based approach of DISE with a flexible, steerable elongate member that can be navigated through the airway using controlled actuation. The imaging device uses optical fibers and light sources rather than requiring surgical-grade endoscopes that necessitate deep anesthesia.
3Difficulty of detecting and measuring
If artificially induced sleep studies are performed with the individual laying on their back, then airway visualization is obtained, but data regarding obstructions in other sleeping positions is not provided
Solution Approach 1:
The medical device incorporates a flexible elongate member with articulation sections that can dynamically adapt to different airway configurations. The device can be repositioned and reconfigured during the study to accommodate various sleeping positions (supine, lateral, prone), allowing comprehensive data collection across multiple positions without requiring separate studies.
Solution Approach 2:
The device allows changes in spatial orientation and configuration parameters of the elongate member to match different sleeping positions. The imaging device can be redirected and the elongate member rearticulated to capture airway anatomy in supine, lateral, and prone positions, providing complete positional data in a single study session.
Data Source
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AI summary
Medical devices are described herein. More particularly, the disclosure relates to medical devices, systems, and methods for the visualization and treatment of bodily passages, such as an airway, sinus cavity, or sinus passages. An exemplary medical device comprises an elongate member, an actuator moveable between an actuator first position and an actuator second position, and a wire member. The elongate member has a first straight, or substantially straight configuration, when the actuator is in the actuator first position and a second curved configuration when the actuator is in the actuator second position.