Disposable Fluid Circuit with Frangible Cannula for Photopheresis
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Solution Overview
Problem
Current extracorporeal photopheresis systems rely on operators to accurately mix and administer photoactive agents like 8-MOP, risking operator error and patient safety due to incorrect dosages, which can lead to ineffective therapy or severe side effects.
Innovation Solution
A disposable fluid circuit with an integrated source of the photoactive agent, featuring a frangible cannula that automatically combines the agent with the collected mononuclear cells, reducing the risk of operator error and ensuring correct dosages through automated flow path opening.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the operator manually prepares and injects the photoactive agent using a syringe, then the operator has control over the administration process, but the risk of operator error increases leading to incorrect dosages and potential patient harm
Solution Approach 1:
The system enables self-service by integrating the photoactive agent directly into the fluid circuit, allowing the agent to be automatically delivered to the treatment container without requiring operator intervention for manual preparation and injection. The frangible cannula automatically opens to allow flow, and the system self-regulates the dosing process.
Solution Approach 2:
The photoactive agent container is merged with the fluid circuit as an integrated component rather than a separate entity. This combining of the agent source with the circuit eliminates the need for separate manual handling steps and ensures the agent is delivered through the same controlled pathway as the blood components.
2Reliability
If a higher 8-MOP dosage is administered to ensure effective therapy, then the therapeutic effect is improved, but severe patient side effects such as skin irritation, eye damage, and increased cancer risk may occur
Solution Approach 1:
The manual mechanical injection process is replaced with an automated fluid delivery system. The frangible cannula provides a predetermined, controlled opening mechanism that replaces operator-controlled syringe injection, ensuring consistent and accurate dosing that prevents both under-dosing and over-dosing.
Solution Approach 2:
The photoactive agent is pre-loaded into the fluid circuit at the correct concentration and volume before the procedure begins. The frangible cannula is pre-positioned to open at the appropriate time, ensuring the correct dosage is delivered in advance without requiring real-time operator judgment or adjustment.
3Adaptability or versatility
If the operator is responsible for correct storage, aseptic techniques, and proper disposal of the photoactive agent, then flexibility in handling is maintained, but the risk of bacterial contamination and operator error increases
Solution Approach 1:
The fluid circuit including the photoactive agent container is designed as a disposable single-use system. This eliminates the need for operator responsibility regarding storage conditions, sterilization procedures, and disposal protocols, as the entire system is discarded after one use, guaranteeing sterility and eliminating cross-contamination risks.
Solution Approach 2:
The photoactive agent is merged with the disposable fluid circuit system, so that the agent, container, and delivery mechanism form an integrated sterile barrier. This combining ensures that the agent remains protected from contamination throughout the procedure without requiring separate sterilization or handling precautions.
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
This solution ensures precise and safe administration of the photoactive agent, minimizing the risk of bacterial contamination and patient side effects by automating the mixing process, thereby enhancing the efficacy of the treatment while reducing operator responsibility.
Implementation Method 1
a frangible cannula for preventing flow of photoactive agent from the container of photoactive agent to the treatment container
Implementation Method 2
a treatment container including walls made of a material that is transparent to light of a selected wavelength
Implementation Method 3
the mononuclear cells are separated (typically by centrifugation) from the remainder of the other whole blood components
Implementation Method 4
subjected to light (typically UV-A) to activate the 8-MOP molecules. The light crosslinks 8-MOP to DNA strands inside the cell
Data Source
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AI summary
Disposable fluid circuits, systems utilizing disposable fluid circuits and methods for combining a treating agent with separated blood component are disclosed. The treating agent is contained within a container and the disposable fluid circuit includes one or more frangible cannulas located in one or more flow paths of the circuit that are selectively opened to establish flow communication between the treating agent container and a treatment container, and/or a separation chamber or other container.