Needle-Shielded Connector Assembly for Sterile Vial Reconstitution
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Solution Overview
Problem
Existing medical injection processes are cumbersome, prone to needle damage and misalignment, expose the needle during reconstitution, pose a risk of injury, and fail to ensure sterility when connecting prefilled syringes to vials, leading to drug loss and needle stick injuries.
Innovation Solution
A connector with a proximal part, distal part, and needle shield that securely attaches to a medical injection device and container, ensuring a tight, sealed connection, protecting the needle, and reducing steps for drug reconstitution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a needle is used to pierce the septum and transfer diluent, then the reconstitution process can be completed, but the needle tip may be damaged due to removal of shield, piercing, and misalignment during insertion
Solution Approach 1:
The connector is pre-assembled with the needle already attached and the shield in place before use. The proximal part is pre-configured with the needle extending through it, so that when the user connects the connector to the syringe, the needle is already positioned and protected, eliminating the need for separate needle attachment steps that could cause misalignment or damage.
2Ease of operation
If the needle is left free and unprotected during reconstitution, then the user can manipulate the syringe, but this represents a high risk of accident and needle stick injuries
Solution Approach 1:
The needle is nested within the proximal part of the connector, which encloses and protects it during storage and transport. When in use, the needle remains partially enclosed by the proximal part structure, providing continuous protection while still allowing the user to manipulate the syringe plunger and connect/disconnect the device.
3Loss of substance
If the user needs to adjust needle insertion depth as drug amount decreases, then the needle can remain in contact with drug, but this handling is hard to perform and leads to significant drug loss
Solution Approach 1:
The connector structure automatically maintains proper needle positioning relative to the container contents. As the user withdraws the connector from the container, the needle naturally remains immersed in the remaining drug solution due to its fixed position within the connector body, eliminating the need for manual repositioning by the user and preventing drug loss from premature needle withdrawal.
4Reliability
If a connection device is designed for disposable use only, then it can be simple in structure, but it cannot ensure sterility when connected to prefilled syringes for long-term storage
Solution Approach 1:
The connector is designed with multi-functionality to serve both disposable reconstitution applications and long-term storage connections with prefilled syringes. The proximal part incorporates sealing surfaces and engagement features that maintain sterility barriers when connected to prefilled syringes, while the overall structure remains suitable for single-use disposal after use, combining multiple functions in a unified design.
Data Source
AI summary
A connector for connecting a medical injection device having a distal tip, a needle extending from the distal tip and a sleeve extending around the tip comprising an inner threaded portion, to a container including a collar closed by a pierceable septum, including: a proximal part configured to sealingly engage the tip of the injection device so as to enclose at least a part of the needle; a distal part configured to be connected to the container, including a skirt configured to extend around the needle when the connector is connected to the injection device; and a needle shield configured to be mounted on the needle, so as to sealingly enclose at least the tip of the needle, the needle shield being configured to be pierced by the needle inserted via the opening for sealingly enclosing said needle.