Semi-Disposable Drug Delivery Device With Rupturing Interface
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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 steps, which can lead to contamination and compromised drug delivery accuracy.
Innovation Solution
A drug delivery device with a reusable module and disposable module featuring a first connecting interface that removably connects to a disposable housing with a protective lid, where the interface includes a rupturing element to open the lid during connection, ensuring sterility by preventing contamination of the inner surface of the reservoir and maintaining the sealing function of the plunger.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a protective lid is added to cover the actuation opening, then sterility is improved, but device complexity increases
Solution Approach 1:
The device is divided into a reusable module and a disposable module, with the protective lid being part of the disposable module. This segmentation allows the lid to be designed specifically for its protective function while being discarded after use, avoiding the need for complex cleaning and sterilization procedures for the reusable parts.
Solution Approach 2:
The protective lid is pre-installed on the disposable module to cover the actuation opening before use. This preliminary protective action ensures sterility is maintained from the start, and the lid is designed to be ruptured at a specific moment during the first actuation, eliminating the need for manual opening operations.
2Ease of operation
If a rupturing element is added to open the protective lid during connection, then ease of operation is improved, but device complexity increases
Solution Approach 1:
The rupturing element is integrated into the connecting interface between the reusable and disposable modules. This merging of the rupturing function with the connection mechanism allows the lid to be opened automatically during the normal assembly process, eliminating the need for separate opening operations while adding minimal structural complexity.
Solution Approach 2:
The protective lid is designed to rupture automatically when the reusable module is connected to the disposable module, without requiring manual intervention. The connection action itself serves to open the lid, making the system self-sufficient and simplifying the user interface.
3Reliability
If the protective lid is made to rupture during connection, then sterility is maintained, but manufacturing precision requirements increase
Solution Approach 1:
The protective lid is designed with a specific local weakness or rupture point that is intentionally created during manufacturing. This localized feature allows the lid to rupture at a controlled location during connection, maintaining sterility by ensuring the rupture occurs only when the module is being assembled, while reducing the need for high-precision manufacturing across the entire component.
Data Source
AI summary
A drug delivery device, such as a wearable patch injector or patch pump for subcutaneous delivery of a fluid medicament from a reservoir, includes a reusable module and a disposable. A protective lid of the disposable module ensures sterility prior to rupturing and reliability of drug delivery after the modules are connected via connecting interfaces of the modules due to the disposable module including a reservoir configured to hold a variable amount of liquid therein and a slidable plunger, and the reusable module including an actuation assembly configured to be extendable through the actuation opening into the disposable module and advance the plunger for drug delivery. The protective lid is ruptured when the reusable module and the disposable module are being connected.