Sterile Valve Assembly for Extended-Wear Drug Delivery
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Solution Overview
Problem
Existing drug delivery devices face challenges in maintaining contact between the device and the patient's skin for extended injection times, especially when administering larger volumes of liquid therapeutic preparations, and there is a need for improved valve mechanisms to ensure sterility and prevent contamination during self-injection.
Innovation Solution
A valve assembly with a valve housing, cannula, pierce plate, and valve boot, featuring a coiled elongate member and elastomeric materials, that moves between pre-use and use positions to facilitate sterile connection and prevent contamination, using a shape memory alloy for the piercing member to ensure efficient and controlled injection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If the injection time is extended to accommodate larger drug volumes, then the patient can receive larger volumes of drug, but the patient cannot maintain contact between the device and the target area of the skin
Solution Approach 1:
The valve assembly is divided into multiple functional components (valve body, elastomeric member, cannula, pierce plate) that work together to maintain sealing and contact. The elastomeric member acts as a separate sealing component that can deform independently to maintain contact with the syringe plunger, allowing the overall device to maintain reliable connection during extended injection periods.
2Duration of action of moving object
If a traditional IV method is used to inject drug slowly into the patient, then the injection time can be extended, but the procedure requires hospital or outpatient setting and cannot be performed as self-injection
Solution Approach 1:
The valve assembly is designed to be self-activating through the interaction between the elastomeric member and the syringe plunger. When the plunger is inserted, the elastomeric member automatically deforms and creates fluid communication without requiring additional activation steps. This self-service mechanism enables patients to perform the injection themselves at home, eliminating the need for hospital-based IV administration while maintaining extended injection duration.
3Extent of automation
If a valve mechanism is added to control fluid flow timing, then the liquid therapeutic preparation can begin to flow at the proper time, but the device complexity increases
Solution Approach 1:
The valve mechanism utilizes changes in the physical state and position of the elastomeric member to control fluid flow. The elastomeric member transitions from a compressed state (blocking flow) to an expanded state (allowing flow) based on the insertion depth of the syringe plunger. This parameter-based control approach provides automated flow timing using a simple elastomeric component rather than a complex multi-part valve mechanism.
4Reliability
If the valve boot moves from pre-use to use position to facilitate connection, then sterile connection can be established, but the mechanism requires additional moving parts
Solution Approach 1:
The valve boot, elastomeric member, and cannula are combined into an integrated assembly where the movement of one component facilitates the function of others. When the syringe plunger compresses the elastomeric member, this single action simultaneously advances the cannula through the valve boot and establishes sterile fluid communication. This merging of functions reduces the need for separate moving parts while maintaining sterility.
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 valve assembly ensures reliable and contamination-free drug delivery over extended periods, maintaining skin contact and facilitating smooth operation of drug delivery devices, particularly for larger volumes, while ensuring sterility and minimizing contamination risks.
Implementation Method 1
a pierce plate including a body and a piercing member extending from the body, with the body formed by a coiled elongate member... using a shape memory alloy for the piercing member
Data Source
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AI summary
A valve assembly for a drug delivery device includes a valve housing having a first side and a second side positioned opposite from the first side, a cannula having a first end and a second end positioned opposite the first end, a pierce plate having a body and a piercing member extending from the body, with the body defining a coiled elongate member, and a valve boot connected to the valve housing and defining an interior space. The valve boot is configured to move from a pre-use position where the first end of the cannula and the piercing member of the pierce plate are received within the interior space to a use position where the piercing member of the pierce plate and the first end of the cannula extend outside of the valve boot and the interior space.