Naloxone Auto-Injector Spring Actuation
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Solution Overview
Problem
Current methods for delivering naloxone, an opioid antagonist, often result in variability and inefficiency due to manual operation, which can lead to incomplete or uneven drug delivery, and may not maintain the desired pharmacokinetic characteristics, especially in emergency situations where access to medical facilities and trained professionals is limited.
Innovation Solution
A medicament delivery device with a housing, a medicament container, and an actuation assembly that includes an energy storage member and a movable member, configured to deliver a dose of naloxone composition in a manner that ensures pharmacokinetic parameters such as plasma concentration and bioavailability are bioequivalent to those achieved with manual syringe delivery, using an energy storage member to move the needle from a retracted position to a position in fluid communication with the container, ensuring consistent and effective delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If manual syringe delivery is used, then ease of operation is improved, but manufacturing precision and reliability deteriorate due to variability in user-generated force
Solution Approach 1:
The patent replaces the manual mechanical system with an automated delivery system that uses a spring-loaded plunger mechanism. The spring is compressed during loading and automatically propels the plunger to deliver the medicament with consistent force, eliminating reliance on user-generated mechanical force while maintaining ease of operation through simple activation.
Solution Approach 2:
The delivery device is designed to perform the delivery function automatically once activated. The spring-loaded mechanism self-propels the plunger without requiring continuous user input or manual force generation, allowing the device to service itself during the critical delivery phase and ensuring consistent pharmacokinetic parameters.
2Manufacturing precision
If automated delivery is used, then manufacturing precision is improved, but device complexity increases
Solution Approach 1:
The device is segmented into distinct functional modules: a housing, a medicament container, a spring-loaded plunger mechanism, and a needle assembly. This segmentation allows each component to be optimized independently while maintaining overall simplicity. The spring mechanism is a separate, self-contained unit that provides automated delivery without requiring complex control systems.
Solution Approach 2:
The patent describes a single-use disposable device where the entire assembly including the spring-loaded mechanism is discarded after one delivery. This approach simplifies the design by eliminating the need for complex reset mechanisms or durable components, allowing optimization for precise single-use delivery without worrying about long-term durability or complex reconfiguration.
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 consistent and effective delivery of naloxone, maintaining bioequivalent pharmacokinetic parameters to manual syringe delivery, even in emergency situations, reducing variability and ensuring reliable reversal of opioid overdose effects.
Implementation Method 1
The actuation assembly includes an energy storage member and a movable member. The energy storage member is configured to produce a force on the movable member to move the needle from a first needle position, in which the needle is disposed within the housing, and a second needle position, in which the needle is placed in fluid communication with the medicament container
Data Source
AI summary
An apparatus includes a container, a needle, and an actuation assembly. The container contains a dose of a naloxone composition having a delivered volume of at least about 0.34 mL. The actuation assembly includes an energy storage member that produces a force on a movable member to move the needle and to deliver the dose of the naloxone composition. The 90% confidence interval of at least one of the relative mean maximum naloxone plasma concentration after dose delivery into the body (C.sub.max), time to reach the maximum naloxone plasma concentration (T.sub.max), area under the plasma concentration-time curve from pre-dose (time 0) extrapolated to infinity (AUC.sub.0-.infin.), or area under the plasma concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration (T.sub.last) (AUC.sub.0-t) of the delivered dose to a delivered dose of a corresponding naloxone composition delivered via a manually-actuated syringe is within 80% to 125%.