Flow Communication Unit With Valve Barrier for Preservative-Free Reuse
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Solution Overview
Problem
Existing drug delivery devices for multiple doses are prone to contamination during extended use, necessitating the use of preservatives that can reduce the efficacy of the drug or be incompatible, and there is a risk of microbial growth without effective microbial barrier properties in the packaging system.
Innovation Solution
A flow communication unit with a unidirectional valve system that allows extended use without preservatives, featuring a connected and unconnected configuration to reduce contamination, including an inlet and outlet surface with sealing members and valves to ensure fluid tightness and prevent microbial ingress.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If a replaceable needle unit is used for multiple injections, then the device can be used for extended use, but the risk of contamination of the cartridge contents increases
Solution Approach 1:
A flow communication unit with valve means is introduced as an intermediary component between the cartridge and the needle unit. The valve means controls fluid flow and prevents backflow, acting as a barrier that allows multiple injections while maintaining cartridge sterility and preventing contamination of the drug formulation.
Solution Approach 2:
The system is divided into separate functional components: a cartridge containing the drug, a flow communication unit with valve means, and a replaceable needle unit. This segmentation allows the needle unit to be replaced for each injection while the cartridge remains sealed and sterile, enabling extended use without increasing contamination risk.
2Reliability
If preservatives are added to prevent microbial growth, then microbial contamination is prevented, but the efficacy of the drug may be reduced or the preservative may be incompatible
Solution Approach 1:
The flow communication unit with valve means serves as a sterile barrier that prevents microbial ingress into the cartridge without requiring preservatives in the drug formulation. This mechanical barrier approach preserves drug efficacy while reliably preventing contamination.
3Productivity
If the outlet surface allows connection to flow conducting device, then flow communication is established, but the entrance of contaminations into the interior space increases
Solution Approach 1:
The outlet surface dynamically changes configuration between connected and unconnected states. When connected, flow communication is established; when unconnected, the outlet surface closes to prevent contamination. This dynamic adaptation allows productive flow communication while preventing contamination during storage or disconnection.
Solution Approach 2:
Different regions of the outlet surface have different functions: one region allows connection and flow communication when needed, while another region provides sealing to prevent contamination when not in use. This local differentiation enables both flow communication and contamination prevention.
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
Enables extended use of drug formulations without preservatives by preventing microbial growth and contamination, maintaining drug efficacy while reducing the risk of needle injuries and maintaining packaging integrity.
Implementation Method 1
an outlet barrier comprising a second outlet valve member adapted to cooperate with the first outlet valve member, wherein the outlet barrier provides a portion of the outlet surface, and wherein the outlet barrier is configured for being in: (i) a closed configuration, wherein the outlet surface is in the unconnected configuration, wherein the second outlet valve member is adapted to cooperate with the first outlet valve member to provide an outlet barrier seal
Implementation Method 2
an outlet sealing member providing a portion of the outlet surface, for the outlet surface being in the connected configuration, wherein the outlet sealing member is adapted for contacting the flow conducting device to establish a fluid tight channel seal
Implementation Method 3
the drug delivery device comprises a pressurizeable reservoir comprising multiple doses of a liquid drug formulation
Implementation Method 4
A flow communication unit with a unidirectional valve system that allows extended use without preservatives, featuring a connected and unconnected configuration to reduce contamination
Data Source
Figure 1A~1C
Figure 1D~1E
Figure 2A~2B
AI summary
A flow communication unit (240, 540, 640, 740, 840, 940, 1040, 1140, 1240) for establishing flow communication from a multi-use drug delivery device adapted for extended use, to a flow conducting device, wherein the drug delivery device comprises a reservoir comprising multiple doses of a liquid drug formulation, wherein the reservoir is adapted to pressurize the liquid drug formulation, wherein the flow conducting device (230) is adapted for conducting the drug to the subcutaneous tissue of a subject, wherein the flow communication unit is adapted for being in an unconnected and a connected configarion, whereby the flow communication unit (240, 540, 640, 740, 840, 940, 1040, 1140,1240) is adapted to enable the extended use of the multi-use drug delivery device.