Sliding Piercable Seal Fluid Pathway Connection
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Solution Overview
Problem
Current drug delivery systems, such as ambulatory infusion pumps, are expensive, bulky, difficult to program, and require specialized care, while manually operated syringes and injection pens lack precision and reliability for adjustable and programmable infusion.
Innovation Solution
A fluid pathway connection integrated into drug containers that maintains sterility and is activated by user-initiated operation, using a sliding pierceable seal and piercing member to connect with a fluid conduit upon activation, ensuring precise and reliable drug delivery without unnecessary steps or components.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If ambulatory infusion pumps are used to provide precise and programmable drug delivery, then delivery precision and reliability are improved, but device complexity, cost, and bulk increase
Solution Approach 1:
The device is divided into distinct functional modules: a sterile disposable cartridge containing the drug reservoir and fluid pathway connection, and a non-sterile reusable pump body. This segmentation allows the complex pump functions to be separated from the sterile drug delivery system, reducing the complexity of the sterile portion while maintaining precise delivery capabilities.
Solution Approach 2:
The fluid pathway connection components (piercing member, sliding pierceable seal, connection hub) are pre-assembled and sterilized together as an integrated unit within the cartridge. This preliminary assembly and sterilization eliminates the need for complex sterilization procedures on the pump body and reduces device complexity by having the sterile pathway ready before use.
2Reliability
If traditional sterilization methods are applied to entire infusion devices, then sterility is ensured, but manufacturing complexity and costs increase
Solution Approach 1:
The device is divided into sterile and non-sterile portions, with only the essential fluid pathway components (cartridge, piercing member, sliding pierceable seal, connection hub) requiring sterilization. This segmentation reduces manufacturing complexity by eliminating the need to sterilize entire devices, while still ensuring sterility where required.
Solution Approach 2:
The fluid pathway connection components are extracted as a separate sterilizable module from the main pump body. This allows these specific components to be sterilized independently using standard methods, while the pump body remains non-sterile, thereby reducing overall manufacturing complexity and costs.
3Device complexity
If fluid pathway connections are integrated into drug containers, then device complexity is reduced, but maintaining sterility during connection becomes more difficult
Solution Approach 1:
The piercing member, sliding pierceable seal, and connection hub are pre-assembled and sterilized together as an integrated unit before being attached to the drug container. This preliminary sterilization of the complete fluid pathway connection ensures sterility is maintained while reducing device complexity through integration.
Solution Approach 2:
The sliding pierceable seal acts as an intermediary barrier that remains sterile until activation. It mediates between the sterile drug container interior and the non-sterile external environment, maintaining sterility during connection while allowing the integrated design to proceed.
4Device complexity
If manual syringes and injection pens are used for drug delivery, then device simplicity and low cost are achieved, but delivery precision and reliability decrease
Solution Approach 1:
The integrated fluid pathway connection with its sliding pierceable seal and piercing member provides automatic sterile barrier breach and fluid pathway establishment when the drive mechanism activates. This self-service mechanism eliminates the need for manual connection steps while maintaining device simplicity, yet enables precise delivery through the integrated design.
Data Source
Figure 1A~1C
Figure 2A~2B
Figure 3A~3B
AI summary
A fluid pathway connection 300 includes a piercing member 330, a connection hub 310, and a sliding pierceable seal 56, wherein the sliding pierceable seal 56 is configured to move from a first position, where the piercing member 330 is initially retained within a sterile cavity 311 between the connection hub 310 and the sliding pierceable seal 56, to a second position, where the pierceable seal 56 has been penetrated by the piercing member 330. A filter 309 may be utilized to enclose the sterile cavity 311 from the outside environment. The fluid pathway connection 300 may further be configured to move to a third position where one or more interconnects 61, 102 and/or one or more corresponding contacts 62, 104 are permitted to transmit a signal to the user. Such fluid pathway connections 300 may be integrated into a drug container 50 having a barrel 58 and a plunger seal 60. A drug delivery pump 10 includes such integrated fluid pathway connections 300 and drug containers 50.