Fluid Path Assembly Needle Shield Valve Member Compact Drug Delivery
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Solution Overview
Problem
Conventional drug delivery devices with crimped glass septum interfaces in cartridge-based primary containers occupy a large footprint, increasing material, storage, and transportation costs, and pose challenges during sterilization due to complex components and particulate risks.
Innovation Solution
A fluid path assembly for drug delivery devices featuring a reservoir with a needle shield valve member that includes a movable needle and barrier, allowing for a compact configuration and easy sterilization, reducing the device's footprint and component count, and utilizing a gas-permeable material for the needle shield valve member.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a crimped glass septum interface is used in a cartridge-based primary container, then the container can be fluidly coupled to the rest of the fluid path, but the device occupies a relatively large footprint
Solution Approach 1:
The needle shield valve member integrates multiple functions: it acts as a needle shield, a valve with barrier, and a fluid path connector. By combining these components into a single integrated structure, the overall device footprint is reduced while maintaining the crimped glass septum interface functionality for fluid path coupling.
Solution Approach 2:
The needle is embedded within or spaced from the barrier of the needle shield valve member, and the reservoir can be positioned within the housing structure. This nested arrangement allows components to occupy overlapping or adjacent spaces, minimizing the overall device length and footprint.
2Reliability
If conventional containers and fill container assemblies with complex components are used, then the device can achieve reliable fluid path sealing, but particulate risk and residuals from sterilization increase
Solution Approach 1:
The design eliminates the separate fill container assembly and its complex crimp interface components by integrating the fluid path coupling directly into the reservoir and needle shield valve member. This extraction of unnecessary components reduces particulate generation during assembly and sterilization while maintaining reliable sealing through the barrier and flange-groove interface.
Solution Approach 2:
The barrier in the needle shield valve member can be made of a flexible material that forms a reliable seal without requiring complex rigid sealing structures. This flexible barrier reduces particulate risk compared to rigid crimped septums while maintaining fluid path sealing reliability.
3Reliability
If conventional configurations with multiple components are used, then the device can achieve proper fluid path sealing and needle protection, but material, storage, and transportation costs increase
Solution Approach 1:
The needle shield valve member combines needle shielding, valving, and fluid path connection functions into a single component, reducing the total number of parts that require materials. This integration maintains needle protection and fluid path sealing while reducing material costs and simplifying storage and transportation.
Solution Approach 2:
The reservoir flange serves multiple functions: it provides structural support, enables attachment to the needle shield valve member via groove engagement, and contributes to the compact overall structure. This multi-functionality reduces the need for additional components, lowering material requirements and costs.
4Length of stationary object
If a compact configuration is implemented, then the device footprint is reduced, but sterilization accessibility may be compromised
Solution Approach 1:
The needle shield valve member body can be made of a flexible, gas-permeable material that allows sterilization gases to penetrate through the component walls. This enables effective sterilization of internal surfaces and embedded components like the needle and barrier without requiring disassembly, maintaining compact dimensions while ensuring complete sterilization.
Solution Approach 2:
Instead of relying on mechanical disassembly for sterilization access, the design uses gas permeable materials that allow sterilization agents to diffuse through the component structure. This replaces the need for mechanical opening/access with a chemical diffusion-based sterilization approach, enabling sterilization of compact, sealed configurations.
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
The solution significantly reduces the device's length by up to 7 mm, saving costs and minimizing particulate risks, while enabling efficient sterilization and maintaining sterility of the fluid path.
Implementation Method 1
a barrier extending between the inlet and the outlet to prevent fluid flow through the body
Implementation Method 2
the body of the needle shield valve member can be made of a material permeable by a sterilization gas
Implementation Method 3
the needle extends through the barrier to establish a fluid path from the interior of the reservoir to the outlet of the body
Data Source
AI summary
Fluid path assemblies for drug delivery devices and methods of establishing a fluid flow path for drug delivery devices are described that include a needle shield valve member that couples to a reservoir having a needle mounted thereto. The needle shield valve member includes an internal barrier that protects the needle and/or contains a drug within the reservoir until activation of the drug delivery device. Upon activation, there is relative movement between the reservoir and needle shield valve member until the needle pierces the barrier to establish a fluid flow path from the reservoir through the needle shield valve member.