Model Face and Airway for Medication Delivery Seal Testing
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Solution Overview
Problem
Current methods for testing medication delivery apparatus face challenges in achieving a seal between the apparatus and test devices, leading to inefficiencies in medication delivery, as small leakages significantly decrease delivery efficiency, and existing standards often require altering the apparatus during testing, which does not simulate real-world conditions effectively.
Innovation Solution
A model face and airway system is developed, simulating bone structure, trachea, soft tissue, and epidermal skin layers, mounted on a test cradle, allowing for clinically appropriate force application and evaluation of medication delivery from devices like pressurized metered dose inhalers, with adjustable positions to test ideal and non-ideal seals, and using a multi-stage cascade impactor for particle size distribution analysis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a seal is achieved between the delivery apparatus and test apparatus, then medication delivery efficiency is improved, but the device complexity and difficulty of testing increase
Solution Approach 1:
The patent uses a facsimile model face that replicates the key geometric and functional features of a human face (contours, nasal cavity, oral cavity, throat) without requiring a real patient. This copying approach enables seal testing and medication delivery evaluation while avoiding the complexity and ethical issues of human testing, thus improving productivity without excessive device complexity
Solution Approach 2:
The facsimile model allows testing under various parameter conditions (different seal qualities, positions, and configurations) that can be adjusted and controlled. By changing parameters like seal tightness, model positioning, and medication delivery settings, comprehensive testing can be performed without increasing fundamental system complexity
2Ease of operation
If the delivery apparatus is altered during testing, then testing simplicity is improved, but the realism and reliability of test results deteriorate
Solution Approach 1:
Instead of altering the actual delivery apparatus, the patent creates a facsimile model that copies the target environment (human face and airway). This allows testing of the unchanged delivery apparatus under realistic conditions, maintaining both ease of operation and reliability of results
Solution Approach 2:
The testing system is segmented into separate components: the unchanged delivery apparatus, the facsimile model, and the test apparatus. This segmentation allows each component to be optimized independently while maintaining realistic interaction, simplifying the overall testing process without compromising reliability
3Object-affected harmful factors
If a facemask is removed during testing, then leakage issues are reduced, but the realism of the test conditions deteriorates
Solution Approach 1:
The facsimile model includes a simplified airway structure that copies the essential geometry of the human respiratory tract. This allows the facemask to be properly positioned and sealed without the complexity of a complete facial structure, reducing leakage while maintaining realistic medication delivery conditions
Solution Approach 2:
The patent extracts only the essential features needed for medication delivery testing (airway geometry, seal surface) from the complete facial structure. This extraction creates a simplified model that reduces leakage issues while preserving the realism of medication delivery conditions
Data Source
AI summary
The present application is directed to systems and methods for evaluating medication delivery from a delivery apparatus using a model face and airway. Generally, a model face and airway may include a simulated bone structure; a simulated trachea defining an air passageway; simulated soft tissue positioned over a least a portion of the simulated bone structure; and a simulated epidermal skin layer surrounding at least one side of the simulated soft tissue. The simulated soft tissue and the simulated epidermal skin layer define at least one of a nasal cavity and a mouth cavity in communication with the air passageway of the simulated trachea.