Sedated Endoscopy Face Mask With One-Way Valve
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Solution Overview
Problem
Current masks fail to adequately ventilate and oxygenate patients during sedated endoscopic procedures, particularly those with anatomical variations or underlying conditions, leading to hypoxia and potential respiratory arrest, as they cannot maintain positive pressure ventilation and seal effectively.
Innovation Solution
A face mask design that includes means for positive airway pressure, a bite block with a one-way valve, and integrated sealing elements to secure a tight fit, allowing connection to CPAP devices and sensing systems for continuous oxygenation and ventilation, while accommodating endoscopic devices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional mask is used during sedated endoscopic procedures, then the patient can breathe spontaneously, but the mask cannot maintain positive pressure ventilation or seal effectively, leading to hypoxia
Solution Approach 1:
The mask is divided into separate functional components: a head portion for sealing, a body portion for ventilation, a bite block for positioning, and integrated one-way valves. This segmentation allows each component to perform its specific function optimally while maintaining overall system reliability for positive pressure ventilation.
Solution Approach 2:
The bite block is integrated within the mask body, and the one-way valves are embedded within the bite block structure. This nesting approach consolidates multiple functions (sealing, ventilation, positioning, and valve operation) into a unified device without proportionally increasing complexity.
2Ease of operation
If higher sedative doses are used to ensure adequate sedation, then the patient is well sedated, but spontaneous respiration deteriorates leading to oxygen tension dipping below 90%
Solution Approach 1:
The one-way valve acts as an intermediary mechanism that allows the mask to adapt to different respiratory states. During spontaneous breathing, the valve opens to allow exhalation; during positive pressure ventilation, the valve directs airflow appropriately. This intermediary structure enables the mask to maintain ventilation reliability across varying sedation levels.
Solution Approach 2:
The mask incorporates dynamic elements including the one-way valve that automatically adjusts its state based on pressure differentials, and the bite block that can be repositioned. These dynamic features allow the system to transition between spontaneous ventilation and positive pressure ventilation modes as sedation depth changes, maintaining ventilation reliability.
3Reliability
If a tight seal is required for positive pressure ventilation, then ventilation effectiveness improves, but the mask becomes difficult to fit on patients with variable facial structures
Solution Approach 1:
The mask incorporates a flexible head portion with a seal that can conform to various facial contours. This flexible sealing surface adapts to different facial structures while maintaining the tight seal necessary for effective positive pressure ventilation, resolving the contradiction between seal reliability and facial adaptability.
Solution Approach 2:
The mask design applies different properties to different regions: the head portion has a flexible, conforming seal for adaptability, while the body portion and bite block provide rigid structural support for ventilation effectiveness. This local differentiation of properties allows the mask to achieve both tight sealing and facial structure adaptability.
4Adaptability or versatility
If the mask accommodates endoscopic devices through an opening, then the procedure can be performed, but the seal is compromised allowing gas leakage
Solution Approach 1:
The one-way valve is extracted as a separate functional element within the bite block, positioned to allow endoscopic device passage while maintaining seal integrity. The valve can be opened to accommodate the endoscope and then closed to restore sealing, enabling both endoscopic access and ventilation reliability.
Solution Approach 2:
The one-way valve operates periodically, opening to allow endoscopic device insertion and then closing to maintain seal integrity during ventilation. This periodic opening and closing action enables the system to alternately accommodate medical devices and maintain sealing, resolving the contradiction between device access and seal reliability.
Data Source
AI summary
A face mask (10) for a patient undergoing a sedated endoscopic procedure. The face mask (10) includes at least one of a duct or an aperture (16, 17) to provide positive airway pressure to the nose, a bite block (18) with an opening therein (20) and a one-way valve (22). The one-way valve (22) has an open position, allowing passage of an endoscopic device therethrough and into the opening (20), and a closed position substantially sealing the opening (20).