Medical Fluid Transfer Apparatus Passive Warming
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Solution Overview
Problem
Current drug delivery systems face challenges with the transfer and administration of high viscosity and high volume drugs from vials, leading to risks such as needle stick injuries, improper mixing, and contamination, especially when transferring from vials to injection devices, which require significant preparation and can result in incomplete drug transfer and waste.
Innovation Solution
A disposable, one-time-use apparatus and method for automatically mixing and transferring the contents of vials into an injection device, which includes a transfer apparatus with a docking station and an expandable chamber that passively warms chilled injectables and features a radiofrequency tag for monitoring patient compliance, and an injection device with a skin-facing surface and tissue displacement structure to ensure accurate and safe drug delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual transfer of drug from vial to injection device is used, then flexibility in drug administration is maintained, but risk of needle stick injury, contamination, and improper mixing increases
Solution Approach 1:
The patent introduces a transfer device as an intermediary system between the vial and injection device. This transfer device includes a receiving chamber that accepts the vial, a transfer mechanism with needle and syringe components, and a control system that automates the aspiration and injection processes. The intermediary transfer device handles the hazardous manual operations, reducing needle stick injuries and contamination risks while maintaining connection between the vial and injection device throughout the process.
Solution Approach 2:
The transfer device incorporates automatic control mechanisms that perform the transfer operations without requiring manual intervention for critical steps. The control system automatically controls the aspiration of drug from the vial, the transfer to the injection device, and the injection process. This self-service capability reduces human error in mixing and administration while maintaining safety, allowing the system to perform complex operations autonomously.
2Manufacturing precision
If overfilling of vial is performed to ensure complete drug transfer, then complete drug delivery is achieved, but drug waste increases
Solution Approach 1:
The transfer device incorporates sensors and control mechanisms that provide feedback during the drug transfer process. The system can detect the volume of drug remaining in the vial and the volume received in the injection device, allowing for real-time monitoring and adjustment of the transfer process. This feedback control enables complete drug transfer without requiring excessive overfilling, as the system can precisely control the aspiration and transfer volumes to match the actual drug availability.
Solution Approach 2:
The patent replaces the manual mechanical process of drug transfer with an automated system that uses controlled mechanical movement of the syringe plunger and needle positioning. The automated control system precisely regulates the aspiration and injection rates, ensuring complete drug transfer without the need for manual estimation or excessive overfilling that would occur with manual techniques.
3Ease of operation
If high viscosity drugs are administered using traditional syringes, then direct injection is possible, but the forces required exceed what can be safely applied to glass container closure systems
Solution Approach 1:
The transfer device segments the drug delivery process into distinct phases: aspiration from vial, transfer through controlled mechanism, and injection into target site. By separating the high-force aspiration phase from the injection phase, the system can apply high forces during drug withdrawal from the vial without compromising the container closure system, as the force is applied through the transfer device's own mechanical system rather than directly to the glass vial during injection.
Solution Approach 2:
The transfer device acts as an intermediary that handles the high-force operations of extracting high viscosity drugs from the vial. The device's mechanical system is designed to generate and control the high forces needed for viscous drug aspiration, then smoothly transitions to the injection phase. This intermediary function protects the glass container closure system from excessive forces while enabling administration of high viscosity drugs that would be difficult or impossible to administer with traditional syringes.
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 enables efficient, safe, and accurate transfer and administration of drugs, reducing the risk of contamination and incomplete transfer, while providing real-time monitoring of patient compliance and ensuring comfortable subcutaneous injection with minimal waste.
Implementation Method 1
the temperature of a single dose of chilled injectable that is transferred through the transfer apparatus into the injection device is passively increased by at least about 5°C.-about 25°C.
Implementation Method 2
an expandable chamber including an inlet that is configured for placement into fluid communication with the transfer apparatus fluid passageway
Data Source
AI summary
Drug delivery system, injection device, transfer apparatus, vial holder and method of administering and transferring are disclosed which provide for passive warming of chilled injectable transferred through the transfer apparatus and into the injection device. The injection device may include a skin-facing surface including a skin boundary displacement extension or structure around a needle injection site to create a high pressure zone in the tissue. Radio frequency tracking and monitoring features for tracking patient compliance also may be provided.