Auto Injector Reconstitution Control Using Inversion-Guided Mixing

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Solution Overview

Problem

Existing auto injectors lack automation in the preparation and administration of medicaments, and there is a need for improved precision and efficiency in delivering fluids to the body, particularly when mixing multiple components. The existing technologies have not addressed the need for precise control in varying circumstances. The existing technologies have not addressed the need for precise control in varying circumstances. The existing technologies have not addressed the need for precise control in varying circumstances. The existing technologies have not addressed the need for precise control in varying circumstances.

Innovation Solution

An auto injector with a processing unit that controls a drive module to move a plunger rod between positions, ensuring thorough mixing of medicament components through inversions, providing an onset signal after a predefined number of inversions, and allowing for orientation-based operations without temperature sensing elements.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Extent of automation

If manual operation of hypodermic syringes is used, then device complexity is reduced, but automation and precision in medicament preparation and administration are insufficient

Engineering Contradiction:
Improveautomation of medicament preparation and administrationVSAvoidcomplexity of auto injector system
Core Design Contradiction:
Extent of automationVSDevice complexity

Solution Approach 1:

The auto injector is configured to automatically perform multiple functions including mixing medicament components, administering the medicament, and ejecting the cartridge without requiring user intervention for each step. The processing unit autonomously controls the drive module to move the plunger rod between positions, counts inversions, and manages the entire injection process sequence.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The auto injector integrates multiple functions into a single device: it can mix different medicament components, administer the medicament, monitor inversion count, and automatically eject the cartridge. The drive module serves multiple purposes by moving the plunger rod for both mixing and administration phases.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Manufacturing precision

If automated mixing process is implemented with inversion counting, then mixing precision and homogeneity are improved, but device complexity and cost increase due to additional sensors and processing requirements

Engineering Contradiction:
Improveprecision of medicament mixingVSAvoidcomplexity of inversion sensing and control system
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The auto injector incorporates a sensor that detects the inversion of the device and provides feedback to the processing unit. The processing unit counts the inversions and uses this information to determine when the mixing process is complete, ensuring precise control over the mixing duration and intensity.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent replaces complex mechanical mixing mechanisms with a simpler system that uses device inversion combined with plunger rod movement. The drive module moves the plunger rod to mix the medicament components during the inversion process, eliminating the need for separate mechanical mixers or stirrers.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Adaptability or versatility

If temperature sensing elements are added for precise control in varying circumstances, then control precision is improved, but device complexity and cost increase

Engineering Contradiction:
Improvecontrol capability in varying circumstancesVSAvoidcomplexity of sensing elements
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent uses the inversion count as an intermediary parameter to control the mixing process. Instead of directly measuring temperature or other environmental conditions, the system uses the number of inversions as a proxy to ensure adequate mixing under varying circumstances, simplifying the sensing requirements.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Stability of the object's composition

If thorough mixing is achieved through multiple inversions, then medicament homogeneity is improved, but administration time increases

Engineering Contradiction:
Improvehomogeneity of medicament mixtureVSAvoidtime required for mixing and administration
Core Design Contradiction:
Stability of the object's compositionVSLoss of time

Solution Approach 1:

The mixing and administration processes are performed continuously without interruption. The drive module moves the plunger rod to mix the medicament components during the inversion process, and immediately afterward, the same plunger rod continues moving to administer the medicament. This eliminates idle time between mixing and administration phases.

Inventive Principle:
Principle #20Continuity of useful action

Data Source

PatentUS12514983B2Auto injector with reconstitution handling support
Publication Date: 2026.01.06 ASCENDIS PHARM AS
  • US12514983B2 patent drawing
  • US12514983B2 patent drawing
  • US12514983B2 patent drawing

AI summary

Disclosed herein is an auto injector for administering a medicament, the auto injector comprising: a housing; a cartridge receiver configured to receive a cartridge comprising a first stopper and a cartridge compartment containing the medicament, the cartridge compartment having a first cartridge subcompartment containing a first medicament component of the medicament and a second cartridge subcompartment containing a second medicament component of the medicament; a drive module coupled to move a plunger rod between a retracted plunger rod position and an extended plunger rod position, the plunger rod being configured to move the first stopper; a processing unit coupled to the drive module, wherein the processing unit is configured to control the drive module to move the plunger rod from a first plunger rod position to a mix plunger rod position with a mix plunger rod speed, wherein the mix plunger rod position is selected to position the first stopper in a position wherein the first medicament component is mixed with the second medicament component, and to provide an onset signal after a number of completed inversions of the auto injector has been performed.