Ampule Autoinjector with Segmented Biasing Mechanism
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Solution Overview
Problem
Current autoinjectors for medications like epinephrine are costly due to aseptic manufacturing requirements and are classified as drug/device combinations, necessitating expensive regulatory approvals, and they become obsolete when the medication expires, requiring the entire device to be replaced.
Innovation Solution
An autoinjector design that includes a first compartment for loading a medicament ampule, which can be broken by a biasing member upon trigger activation, and a second compartment for fluid communication with an output needle, allowing the medicament to be injected without the need for aseptic manufacturing and enabling ampule replacement, thus reducing costs and regulatory burdens.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Extent of automation
If autoinjectors use pre-filled syringes or drug bottles with membrane tops, then automatic injection function is achieved, but manufacturing cost increases due to aseptic manufacturing requirements
Solution Approach 1:
The device is divided into separate functional components: a reusable autoinjector body and replaceable ampules. This segmentation allows the expensive automated injection mechanism to be reused while only the inexpensive ampules need to be manufactured under strict aseptic conditions, thereby reducing overall manufacturing costs.
Solution Approach 2:
The invention uses disposable glass ampules instead of expensive pre-filled syringes. The ampules are inexpensive, single-use containers that can be manufactured more economically and then loaded into the reusable autoinjector body, reducing the cost burden while maintaining automated injection functionality.
2Extent of automation
If autoinjectors use pre-filled syringes or drug bottles, then automatic injection is enabled, but regulatory approval process becomes expensive and time-consuming due to drug/device combination classification
Solution Approach 1:
By separating the device into a reusable autoinjector body and replaceable ampules, the system avoids being classified as a drug/device combination. The ampules serve as simple drug containers rather than integrated drug delivery systems, simplifying regulatory classification and reducing approval complexity.
3Reliability
If the entire autoinjector is replaced when medication expires, then drug freshness is ensured, but device waste increases and cost increases
Solution Approach 1:
The reusable body and disposable ampule segmentation enables users to replace only the expired ampule while retaining the functional autoinjector body. This eliminates the need to discard the entire device, reducing waste and allowing continued use of the expensive automated injection mechanism with new ampules.
Solution Approach 2:
The invention allows recovery and continued use of the reusable autoinjector body after the ampule is consumed or expired. Users discard only the used ampule and reload a new one into the same device, maximizing device utilization and minimizing waste.
4Adaptability or versatility
If manual injection components (syringe, needle, ampule) are kept separate, then flexibility is maintained, but user convenience decreases due to need to carry multiple components
Solution Approach 1:
The invention merges the ampule loading and automated injection functions into a single integrated autoinjector device. Users carry one compact device that combines the benefits of separate components (flexibility to use different ampules) with the convenience of an integrated system (no assembly required at point of use).
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 autoinjector provides a cost-effective, user-friendly solution for administering medications by allowing ampule replacement and simplifying the manufacturing process, reducing waste and regulatory complexities, while ensuring accurate and efficient dosing.
Implementation Method 1
a first biasing member coupled to the first trigger... configured to, upon application of force to the first trigger, automatically move an ampule when loaded in the main body in a distal direction relative to the main body to force the ampule against the protrusion
Implementation Method 2
a second biasing member coupled to a second trigger... configured to, upon application of force to the second trigger, automatically move the first compartment in the distal direction relative to the outer housing and the second compartment to force medicament from the second compartment to the output needle
Data Source
AI summary
An autoinjector is described that includes an outer body, a first trigger, an output needle, and a first compartment. The first compartment is positioned within the outer body and includes (i) a main body, (ii) a first biasing member coupled to the first trigger, and (iii) a protrusion positioned at a distal end of the main body. The autoinjector further includes a second compartment positioned in the outer body and in fluid communication with the first compartment and the output needle. The autoinjector also includes a second biasing member coupled to a second trigger. The first biasing member is configured to, upon application of force to the first trigger, automatically move an ampule in a distal direction relative to the main body to force the ampule against the protrusion, so as to break the ampule and allow a medicament to flow from the ampule to the second compartment.