Modular Needle Connectors for Multi-Dose Septum Piercing
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Solution Overview
Problem
Existing multi-dose injection systems cause contamination of therapeutic agents due to repeated piercing of the septum by needle connectors, leading to rubber particle generation and potential adverse effects on patients.
Innovation Solution
The system employs modular, attachable needle connectors with varied proximal needle locations and anti-rotation features to ensure that the septum is pierced at different locations, reducing the frequency of piercing at any given spot and minimizing contamination.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a needle assembly is designed to accept multiple cartridges, then the device can deliver multiple different drugs or formulations, but the complexity of the connector system increases
Solution Approach 1:
The needle assembly is designed with a universal connector that can accept multiple different cartridge types through a single standardized interface. The connector includes a receptacle with engagement features that are compatible with various cartridge configurations, allowing one needle assembly to deliver multiple different drugs or formulations without requiring separate assemblies for each cartridge type.
Solution Approach 2:
The connector system is divided into separate functional components: a receptacle portion, an interference fit section, and a latch mechanism. This segmentation allows each component to perform its specific function independently while maintaining overall system simplicity. The receptacle accepts different cartridge types, the interference fit section provides secure mechanical coupling, and the latch mechanism ensures proper engagement and sealing.
2Reliability
If a needle assembly is designed for single use and then discarded, then contamination risk is reduced, but the cost and waste increase
Solution Approach 1:
The needle assembly is designed as a disposable component that is intended for single use and then discarded. This ensures that the needle assembly and any connected cartridge are guaranteed to be sterile and free from contamination, as the entire assembly is replaced rather than cleaned or sterilized between uses. The design accepts that the needle assembly will be discarded after one use to maintain reliability and prevent contamination.
Solution Approach 2:
The needle assembly includes features that facilitate easy attachment and detachment of cartridges, allowing the reusable portion of the device to be separated from the disposable needle assembly and cartridge. This enables recovery and reuse of expensive components while the needle assembly and cartridge are discarded as single-use items, optimizing the balance between cost, waste, and contamination prevention.
3Reliability
If the needle assembly includes features to prevent reattachment of used cartridges, then patient safety is improved, but the device complexity increases
Solution Approach 1:
The connector includes asymmetric features such as a cam-shaped latch and corresponding engagement surfaces that allow easy attachment in one direction but prevent reattachment after use. The latch mechanism is designed to engage smoothly during initial attachment but becomes mechanically locked or misaligned if removal and reattachment are attempted, providing patient safety through prevention of reuse while maintaining relatively simple device architecture.
Solution Approach 2:
The anti-reattachment features are built into the connector design from the beginning, with pre-configured mechanical constraints and asymmetric engagement surfaces that prevent misuse before it can occur. The latch mechanism is pre-set to engage in a specific orientation and includes features that become deactivated or misaligned after removal, eliminating the need for additional complex safety systems or user actions to prevent reattachment.
Data Source
Figure 1
Figure 2A~2C
Figure 3A~3B
AI summary
Systems and devices described herein include multi-dose injection systems for delivering drugs, hormones, biologics, and other therapeutic agents. Systems include multiple single-injection needle connectors attachable to a reusable injector. The needle connectors include a needle having a distal end for administering the therapeutic agent to the patient and a proximal end to pierce a septum of the reusable injector. The proximal ends of the needles across the multiple needle connectors can vary such that the piercing location on the septum varies. The systems also include modular needle connectors. The modular needle connectors can include a disk rotatable within a connector body. A position of a needle within the rotatable disk changes each time the modular needle connector is connected to a reusable injector.