Semi-Disposable Drug Delivery Interface With Rupturable Sterile Lid
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Solution Overview
Problem
Existing semi-disposable drug delivery devices face challenges in ensuring sterility and reliability at the interface between reusable and disposable modules, particularly during manual handling and use in non-sterile environments, which can lead to contamination and compromised drug delivery.
Innovation Solution
A drug delivery device with a reusable module and disposable module featuring a protective lid that covers the actuation opening, and a rupturing means integrated into the connecting interface to ensure sterility by rupturing the lid during connection, allowing the actuation assembly to advance without contacting the lid, thus maintaining the integrity of the reservoir and plunger sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a protective lid covers the actuation opening to maintain sterility, then the risk of contamination is reduced, but the actuation assembly cannot advance into the disposable module until the lid is removed
Solution Approach 1:
The protective lid is pre-positioned to cover the actuation opening before use, maintaining sterility during storage and handling. The lid is designed to be automatically removed or broken during the connection process, enabling the actuation assembly to advance without requiring separate manual removal steps.
Solution Approach 2:
The protective lid is extracted or removed from the actuation opening during the connection process, allowing the actuation assembly to advance into the disposable module. This separation enables the sterility function to be maintained initially while permitting access when needed.
2Ease of operation
If the actuation assembly advances through the actuation opening, then drug delivery is enabled, but the protective lid must be removed which increases contamination risk
Solution Approach 1:
The protective lid is designed to be removed or broken in advance during the connection process, before the actuation assembly needs to advance. This preliminary removal eliminates the need to compromise sterility during the actual drug delivery operation.
Solution Approach 2:
The protective lid is quickly broken or removed during the connection process, minimizing the time the actuation opening is exposed to potential contamination. The rapid transition from protected to accessible state reduces the window of vulnerability.
3Reliability
If additional components are added to maintain sterility at the interface, then contamination is prevented, but device complexity increases
Solution Approach 1:
The protective lid function is merged with the existing actuation opening structure, eliminating the need for separate sterilization mechanisms. The lid serves both as a protective barrier and as an integrated part of the module interface, reducing overall component count.
Solution Approach 2:
The protective lid serves multiple functions: maintaining sterility during storage and handling, enabling easy identification of the actuation opening, and facilitating the connection process through its designed removal mechanism. This multi-functionality reduces the need for additional dedicated components.
Data Source
Figure 1a~1b
Figure 1c~2
Figure 3a~3b
AI summary
The present invention is concerned with a drug delivery device, in particular with a wearable patch injector or patch pump for subcutaneous delivery of a fluid medicament from a reservoir. The invention includes an improved design of an interface between a reusable and a disposable portion of the drug delivery device, where a protective lid is attached to the housing of the disposable module to ensure sterility and reliability of drug delivery. The protective lid is ruptured when the reusable module and the disposable module are being connected.