Air-Intake Nasal Delivery Device with Valve Segmentation
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Solution Overview
Problem
Traditional nasal delivery devices struggle to achieve optimal efficacy due to issues like nasal irritation, limited absorption surface area, and inefficient delivery of substances to the nasal epithelia, leading to low bioavailability and poor patient compliance.
Innovation Solution
An air-intake actuated device that utilizes the natural swallowing mechanism to isolate the nasal passageways from the respiratory system, featuring a valve system that activates upon air intake to deliver a predetermined amount of substance directly to the nasal cavity, ensuring accurate dosing, minimal lung deposition, and improved penetration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If traditional nasal delivery devices present medicament in a stream, then the device structure is simple, but much of the medicament runs out of the patient's nose and only a small amount reaches the nasal epithelia
Solution Approach 1:
The device segments the medicament delivery process into multiple stages: initial stream delivery to fill the nasal cavity, followed by controlled droplet delivery to ensure proper distribution on the nasal epithelia. This segmentation allows the device to achieve both simple structure and precise delivery by breaking down the complex delivery task into manageable phases.
Solution Approach 2:
The device employs periodic action by delivering medicament in alternating patterns of streams and droplets. The stream delivery phase is followed by a droplet delivery phase, creating a periodic cycle that optimizes both coverage and precision. This periodic delivery pattern ensures that medicament is first distributed broadly then precisely placed on target areas.
2Speed
If nasal delivery devices deliver substance directly to nasal cavity, then absorption rate improves, but nasal irritation occurs
Solution Approach 1:
The device changes the physical parameters of medicament delivery by alternating between stream mode (higher flow rate, lower concentration contact) and droplet mode (lower flow rate, higher concentration contact). This parameter variation allows rapid absorption through streams while minimizing irritation through controlled droplet delivery, optimizing both speed and safety.
Solution Approach 2:
The device acts as an intermediary that controls the interaction between medicament and nasal tissue. By regulating delivery mode (stream vs. droplet) and timing, the device mediates between the need for rapid absorption and the need to minimize irritation, delivering medicament in a way that balances efficacy and patient comfort.
3Reliability
If air-exhale activated devices are used, then nasal delivery is improved during exhalation, but the device cannot deliver substance during inhalation when soft palate is open
Solution Approach 1:
The device achieves multi-functionality by being capable of both air-exhale activation and air-intake activation. This universal design allows the device to adapt to different breathing phases and deliver medicament reliably whether the patient is exhaling or inhaling, overcoming the limitation of single-mode activation devices.
Solution Approach 2:
The device employs dynamic activation by responding to different breathing mechanisms (exhalation vs. inhalation) rather than being fixed to one mode. The activation mechanism dynamically adapts to the patient's breathing pattern, ensuring reliable delivery regardless of whether the soft palate is closed or open, thus maintaining versatility while ensuring reliability.
4Quantity of substance
If valve remains open for extended period, then more substance can be delivered, but substance may enter lungs instead of nasal cavity
Solution Approach 1:
The valve operates through periodic opening and closing cycles synchronized with breathing phases. During inhalation when soft palate is open, the valve closes to prevent lung deposition. During exhalation when soft palate closes, the valve opens to deliver substance to the nasal cavity. This periodic operation ensures adequate substance delivery while preventing harmful lung exposure.
Solution Approach 2:
The device incorporates feedback from the patient's breathing pattern to control valve timing. By detecting breathing phase (inhalation vs. exhalation), the system adjusts valve operation accordingly - closing during inhalation to prevent lung deposition and opening during exhalation to enable nasal delivery. This feedback mechanism balances quantity delivery with safety.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device ensures precise and efficient delivery of substances to the nasal epithelium, enhancing bioavailability, patient compliance, and minimizing side effects like nasal irritation, while preventing entry into the lungs.
Implementation Method 1
a valve system that activates upon air intake to deliver a predetermined amount of substance directly to the nasal cavity
Data Source
AI summary
The present invention provides a method for delivering a substance to the nasal cavity of a subject in which drawing air from a mouthpiece triggers release of a substance to a subject's nasal cavities. The device comprises a container for containing the substance in fluid communication with a nosepiece, a valve with an active configuration and an inactive configuration, and a trigger mechanism to reconfigure the valve from its inactive configuration to its active configuration and vice versa. Drawing air from the mouthpiece, e.g., when the subject takes in air by mouth, activates the trigger mechanism, thereby reconfiguring the valve from its inactive configuration to its active configuration for a predetermined period of time and delivering the substance from the device to a nasal cavity of the subject.