Silicone-Free Syringe Plunger Locking for Precise Dose Delivery
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Solution Overview
Problem
Existing drug delivery systems face challenges in achieving precise dose delivery, maintaining sterility during handling, and efficient sterilization of medical devices, particularly pre-filled syringes, which can lead to contamination and inaccurate dosing.
Innovation Solution
The system includes a drug delivery device with a plunger rod and flange configuration that allows for precise dose delivery and priming, a silicone-free design to prevent contamination, and a packaging system with a flexible tray and removable cover for sterilization using vaporized hydrogen peroxide.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional drug delivery systems are used, then device simplicity is maintained, but dose delivery precision deteriorates
Solution Approach 1:
The plunger rod is segmented into multiple functional sections: a body portion, a dose setting portion with circumferential grooves for volume measurement, and a flange portion with engagement features. This segmentation allows each section to perform its specific function while maintaining overall device precision without excessive complexity.
Solution Approach 2:
The device incorporates preliminary priming actions where the plunger rod is pre-configured to automatically prime the delivery system by forcing fluid through the needle upon initial actuation. This preliminary action ensures accurate dosing without requiring separate priming steps, maintaining precision while controlling complexity.
2Ease of operation
If handling and storage operations are performed, then device usability is improved, but sterility is compromised
Solution Approach 1:
The dose delivery device is nested within a sterile packaging system consisting of a sterile barrier pouch and an outer package. The device remains protected within these nested layers during handling and storage, maintaining sterility while allowing easy access when needed.
Solution Approach 2:
The device is pre-sterilized and sealed within the sterile barrier pouch before distribution. This preliminary sterilization action ensures sterility is maintained throughout storage and handling without requiring additional protective measures during normal operations.
3Reliability
If conventional sterilization methods are used, then sterilization effectiveness is achieved, but device contamination risk increases
Solution Approach 1:
A sterile barrier pouch acts as an intermediary between the sterilization process and the dose delivery device. The pouch allows sterilization agents to penetrate and sterilize the device while protecting it from contamination during handling and storage, reducing contamination risk while maintaining sterilization effectiveness.
Solution Approach 2:
The sterile barrier pouch creates an inert, sterile environment around the device during storage and transport. This inert atmosphere prevents contamination while allowing the device to remain sterilized without exposure to harmful external factors.
4Ease of operation
If multiple handling operations are performed, then device accessibility is improved, but contamination probability increases
Solution Approach 1:
The device is nested within multiple packaging layers (sterile barrier pouch within outer package) that can be sequentially opened. This nested structure allows the device to remain protected and inaccessible to contaminants during storage, then becomes progressively accessible during use without requiring the device itself to be handled prematurely.
Solution Approach 2:
The packaging system acts as an intermediary that controls access to the device. The sterile barrier pouch and outer package serve as intermediate barriers that can be opened in a controlled manner, allowing the device to be accessed when needed while preventing contamination during storage and transport.
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 system ensures accurate dose delivery, maintains sterility, and reduces handling-induced contamination, while enabling efficient sterilization of medical devices, particularly pre-filled syringes, thereby improving patient safety and treatment efficacy.
Implementation Method 1
sterilizing the packaging assembly by conducting a sterilant exposure that includes exposing the packaging assembly to vaporized hydrogen peroxide
Implementation Method 2
distal movement of the plunger rod relative to the body is limited upon the pair of protrusions extending into the pair of slots to deliver the medicament from the body
Data Source
AI summary
A drug delivery device that includes a body storing a VEGF antagonist, a plunger rod contacting a stopper inside the body, and a flange coupled to the body. The body is silicone-free. The plunger rod includes protrusions and the flange includes a proximal collar and slots positioned along the proximal collar. The flange is configured such that when the protrusions and slots are misaligned, distal movement of the plunger rod relative to the body is limited upon the protrusions contacting the proximal collar to prime the drug delivery device. The flange is configured such that when the protrusions and slots are aligned, distal movement of the plunger rod relative to the body is limited upon the protrusions extending into the slots to deliver the VEGF antagonist.