Large-Volume Injector Assembly for Aseptic Fluid Connection
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing large volume injection devices face challenges in establishing a sterile or aseptic connection between the medicament container and the fluid flow path, complicating assembly and increasing costs.
Innovation Solution
A method involving a medicament delivery device with a moveable medicament container sled, needle insertion mechanism, and drive mechanism, allowing for aseptic connection by securing the medicament container in the sled and activating the drive mechanism to apply pressure to the plunger, thereby establishing a fluid connection with the fluid path.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional large volume injection devices are assembled in a clean room environment to ensure sterility, then the sterility of the device is improved, but the manufacturing complexity and cost increase
Solution Approach 1:
The device is divided into sterile components (medicament container, fluid path) and non-sterile components (external housing, drive mechanism). The sterile components are pre-assembled and sealed in a sterile barrier, allowing final assembly to occur outside the clean room while maintaining sterility through the barrier until the moment of use.
Solution Approach 2:
The sterile components are prepared and sealed in advance within a sterile barrier package. This preliminary sterile assembly eliminates the need for clean room conditions during final device assembly, as the sterile integrity is already established before the device leaves the manufacturing environment.
2Reliability
If traditional large volume injection devices use complex sterilization and connection mechanisms, then the sterility is improved, but the manufacturing cost increases
Solution Approach 1:
The device employs a disposable sterile barrier package that is discarded after single use. This eliminates the need for expensive, complex sterilization mechanisms and allows standard manufacturing processes to be used, significantly reducing manufacturing costs while maintaining sterility through the barrier until use.
3Reliability
If the medicament container is securely connected to the fluid path, then the sterility is improved, but the device complexity increases
Solution Approach 1:
The connection between the medicament container and fluid path is pre-established within the sterile barrier during manufacturing. This preliminary connection eliminates the need for complex connection mechanisms during patient use, as the sterile integrity and fluid connection are already established before the device leaves the manufacturing environment.
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 aseptic connection of the medicament container with the fluid path without requiring a clean room environment for all assembly steps, reducing complexity and cost while maintaining sterility.
Implementation Method 1
activating the drive mechanism to cause the drive mechanism to apply pressure to the plunger of the medicament container
Data Source
AI summary
A method of operating a medicament delivery device is provided. The method can include selecting a medicament delivery device, comprising: an external housing including a substantially rigid body; a moveable medicament container sled; a needle insertion mechanism; a fluid path operable to connect a needle of the needle insertion mechanism with a medicament container; a medicament container including a container body and plunger, wherein the medicament container is secured in a portion of the moveable medicament container sled; and a drive mechanism. The method can include applying the medicament delivery device to a skin surface of a patient; and activating the medicament delivery device to cause the drive mechanism to apply pressure to the plunger of the medicament container, wherein activating the medicament delivery device comprises releasing a latch mechanism of the drive mechanism.