Bi-Dose Nasal Spray for Orientation-Independent Dosing

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Solution Overview

Problem

Existing nasal sprays for administering anxiolytic or anticonvulsant agents like midazolam face challenges in ensuring uniform and orientation-independent dosing, particularly in non-upright positions, leading to variability in drug administration and potential patient discomfort or ineffective treatment due to incorrect dosing and hygiene issues.

Innovation Solution

A bi-dose nasal spray device that allows for two equal sprays of a defined volume of an active agent, such as midazolam, to be administered regardless of the patient's position, using a spring-driven mechanism with an airtight seal and blocking system to ensure precise dosing without prior activation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a nasal spray is used in non-upright positions, then patient comfort and accessibility are improved, but dosing uniformity and medication delivery precision deteriorate

Engineering Contradiction:
Improvepatient comfortVSAvoiddosing uniformity
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The nasal spray device incorporates a spring-driven mechanism that dynamically adjusts to different orientations. The spring force compensates for gravitational effects in various positions, ensuring consistent spray delivery whether the patient is upright, lying down, or in intermediate positions. This dynamic adaptation resolves the contradiction between patient comfort in non-upright positions and dosing uniformity.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The device changes the physical parameters of spray delivery by using a spring-driven pressurization system instead of gravity-dependent flow. By altering the driving force from gravitational to elastic spring force, the system maintains consistent spray characteristics across different orientations, thereby preserving dosing uniformity while improving ease of operation in various positions.

Inventive Principle:
Principle #35Parameter changes

2Manufacturing precision

If a nasal spray requires prior activation, then dosing control is improved, but treatment time and operational complexity worsen

Engineering Contradiction:
Improvedosing controlVSAvoidtreatment time
Core Design Contradiction:
Manufacturing precisionVSLoss of time

Solution Approach 1:

The nasal spray device is pre-loaded with the spring mechanism and medication reservoir during manufacturing, ready for immediate use. The spring is pre-compressed or pre-positioned to deliver the correct dose without requiring activation steps by the patient. This preliminary preparation maintains dosing control while eliminating activation time, resolving the contradiction between dosing precision and treatment speed.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The spring-driven mechanism automatically delivers the prescribed dose without requiring manual activation or complex user operations. The device self-regulates the spray delivery through the spring's mechanical action, ensuring accurate dosing control while minimizing the time and effort required from the patient, thus resolving the contradiction between dosing precision and treatment time.

Inventive Principle:
Principle #25Self-service

3Object-affected harmful factors

If a nasal spray is designed for single-use, then hygiene and contamination prevention are improved, but device complexity and cost worsen

Engineering Contradiction:
Improvecontamination riskVSAvoiddevice complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The nasal spray is designed as a disposable single-use device with an integrated spring mechanism and medication reservoir. The entire assembly is inexpensive to manufacture and can be discarded after one use, eliminating contamination risks without requiring complex reusable components that need cleaning and sterilization. This approach resolves the contradiction between hygiene and device complexity by using a simple, disposable design.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

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

Enables consistent and hygienic administration of anxiolytic or anticonvulsant agents, improving treatment efficacy in situations like MRI scans and emergency seizures by ensuring accurate dosing in any position, reducing patient discomfort and minimizing contamination risks.

Implementation Method 1

using a spring-driven mechanism with an airtight seal and blocking system to ensure precise dosing

Methodology Applied
Scientific EffectSpring mechanism: Spring

Data Source

PatentEP4382149B1Bi-dose nasal spray
Publication Date: 2025.11.19 AKROSWISS AG
  • EP4382149B1 patent drawingFigure 1
  • EP4382149B1 patent drawingFigure 2
  • EP4382149B1 patent drawingFigure 3

AI summary

The present invention relates to a novel nasal spray containing an aqueous solution or a fluid with an anxiolytic or anticonvulsant substance, wherein the nasal spray is characterized in that with the nasal spray, two sprays with each an equivalent, defined volume of the aqueous solution or liquid of the active agent, can be intranasally administered to a patient and wherein the nasal spray allows for an administration, independent of the spatial orientation of the nasal spray in any position of the patient (standing upright, sitting, lying or in any intermediate position). The nasal spray can be used directly without prior activation. Preferably it is apparent from the nasal spray whether a spray or even a second spray has been made with the nasal spray. Preferably, a spray of the nasal spray can be administered one-handed by the patient or a third person. The active agent in the inventive nasal spray is a benzodiazepine or a GABA-receptor agonist, preferably midazolam or a derivative thereof or a salt of these active agents. The nasal spray according to the present invention may be used for sedation, premedication or treatment of patients with claustrophobia, anxiety disorders or panic attacks or for the treatment of convulsions in CNS diseases, particularly in epileptic seizures or other manifestations of seizures (e.g. febrile convulsions). The invention also relates to a method for hermetically sealing an active agent container for use in supplying an nasal spray in accordance with the invention. The invention also relates to a method of detection by localizing the locally precise administration of an active agent in nasal application, as well as a nasal spray, preferably a bi-dose nasal spray, for which, using the cited method of detection, it has been shown both visually (qualitatively) and quantitatively that an orientation-independent, uniform and locally precise administration of the dose of the active agent onto the nasal mucosa of a patient can be achieved. Also provided is a method for airless and air-tight sealing of an active agent container in accordance with the invention.