Pierceable Seal Fluid Pathway Connection for Sterile Drug Delivery
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Solution Overview
Problem
Current drug delivery devices face challenges such as high costs, complexity, and sterility issues due to the need for terminal sterilization, which limits their manufacturing efficiency and increases costs, and they often require specialized handling and maintenance, making them cumbersome and expensive for both patients and healthcare providers.
Innovation Solution
The development of user-initiated container connections that maintain sterility by keeping the fluid pathway disconnected until activation, using a piercing member and sleeve assembly that forms a sterile volume within a pierceable seal, allowing for safe and efficient connection and fluid flow, reducing the need for terminal sterilization and enabling pre-filled devices with standard fill-finish processes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If terminal sterilization is used to ensure sterility of the fluid pathway, then sterility is improved, but manufacturing complexity and cost increase
Solution Approach 1:
The device is divided into sterile components (piercing member, fluid pathway) and non-sterile components (housing, control system). The sterile components are pre-sterilized and packaged separately, then connected to the non-sterile components at the point of use, eliminating the need to sterilize the entire device.
Solution Approach 2:
The piercing member and fluid pathway are pre-sterilized and pre-packaged in sterile condition before use. The sterile barrier is maintained until the moment of connection, at which point the sterile components are already prepared and ready for immediate use without requiring terminal sterilization of the complete device.
2Reliability
If terminal sterilization is used to maintain sterility, then sterility is improved, but manufacturing cost increases
Solution Approach 1:
The device is divided into sterile components (piercing member, fluid pathway) and non-sterile components (housing, control system). The sterile components are pre-sterilized and packaged separately, then connected to the non-sterile components at the point of use, eliminating the need to sterilize the entire device.
Solution Approach 2:
The piercing member and fluid pathway are designed as disposable sterile components that are pre-sterilized and discarded after single use. This eliminates the need for expensive terminal sterilization of reusable components and allows for cost-effective manufacturing of the non-sterile portions of the device.
3Ease of operation
If the fluid pathway is kept connected for ease of use, then ease of operation is improved, but sterility is compromised
Solution Approach 1:
A sterile barrier (pierceable seal with piercing member) acts as an intermediary that maintains sterility during storage and transport. The barrier is breached only at the moment of use through a controlled piercing action, allowing the fluid pathway to remain sterile until connection is needed while enabling easy operation at the point of use.
4Ease of manufacture
If pre-filled devices are manufactured without terminal sterilization, then manufacturing cost decreases, but risk of contamination increases
Solution Approach 1:
The device is divided into sterile components (piercing member, fluid pathway) and non-sterile components (housing, control system). The sterile components are pre-sterilized and packaged separately, then connected to the non-sterile components at the point of use, eliminating the need to sterilize the entire device.
Solution Approach 2:
The piercing member and fluid pathway are pre-sterilized and pre-packaged in sterile condition before use. The sterile barrier is maintained until the moment of connection, at which point the sterile components are already prepared and ready for immediate use without requiring terminal sterilization of the complete device.
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
This solution provides a cost-effective, user-friendly, and sterile drug delivery system that simplifies manufacturing, reduces the risk of contamination, and allows for the use of less expensive materials, while ensuring the sterility and safety of the fluid pathway, making it suitable for self-administration and reducing the burden on healthcare systems.
Implementation Method 1
a piercing member and sleeve assembly that forms a sterile volume within a pierceable seal, allowing for safe and efficient connection and fluid flow
Implementation Method 2
maintain sterility by keeping the fluid pathway disconnected until activation, using a piercing member and sleeve assembly that forms a sterile volume within a pierceable seal
Data Source
AI summary
Provided herein is a fluid pathway connection assembly, e.g., for connecting a fluid flowpath within a drug delivery device for delivery of a medicament to a target site. The fluid pathway connection assembly comprises a hollow needle piercing member, a sleeve fixedly engaged with the piercing member and a pierceable seal configured to sealingly engage the piercing member or the sleeve. Upon, sealing engagement, the piercing member or the sleeve and the pierceable seal form a volume within which a portion of the piercing member is disposed. The fluid pathway connection assembly is activated by relative movement between the piercing member and the pierceable seal and activation causes the piercing member to pierce the pierceable seal, thereby establishing a fluid flowpath through the pierceable seal. Upon incorporation of the assembly into a sealed fluid flowpath, the volume is isolated from the environment and maintains the sterile condition of the portion of the piercing member disposed therein. Also provided herein are drug delivery pumps and methods of operating and assembling the assemblies and pumps described herein.