Systems and methods for monitoring and controlling fluid balance during a biological fluid procedure

A method for monitoring and controlling fluid volume balance during an extracorporeal photopheresis procedure, driven and adjusted by a microprocessor-based controller, comprising the steps of:

• configuring the controller manually or automatically with a first set of inputs comprising a hematocrit of a blood source, a total blood volume of the blood source, and an ACD ratio relating unanticoagulated extracorporeal whole blood to anticoagulant solution;
• estimating based on the first set of inputs a maximum extracorporeal red blood cell amount during the procedure;
• priming a fluid circuit with a priming fluid having a prime fluid hematocrit value inputted into the controller;
• drawing whole blood from the blood source into the fluid circuit and a separator;
• separating the whole blood into a red blood cell component, a target cell component, and a plasma component;
• directing the target cell component to a product container;
• treating the product container comprising the target cell component to create a treated target cell component;
• returning to the blood source the treated target cell component, a portion of the red blood cell component remaining in the fluid circuit, and/or a portion of the plasma component remaining in the fluid circuit;
• and
• providing a first response action if the maximum extracorporeal red blood cell amount estimated is above a programmed limit.

A method for monitoring and controlling fluid volume balance during an extracorporeal photopheresis procedure, driven and adjusted by a microprocessor-based controller, comprising the steps of:

• 1) configuring the controller manually or automatically with inputs comprising a hematocrit of a blood source, a total blood volume of the blood source, an ACD ratio relating unanticoagulated extracorporeal whole blood to anticoagulant solution, a citrate infusion threshold rate, a volume of whole blood to process, and a patient body weight associated with the blood source;
• 2) priming a fluid circuit with a priming fluid;
• 3) returning none or some of the priming fluid to the blood source;
• 4) withdrawing whole blood from the blood source into the fluid circuit at a first flow rate and withdrawing anticoagulant solution at a second flow rate in accordance with the ACD ratio, the citrate infusion threshold rate, the volume of whole blood to process, and the patient body weight;
• 5) separating within a separation chamber the whole blood into a red blood cell component, a mononuclear cell component, and a plasma component;
• 6) returning a first portion of the red blood cell component and a first portion of the plasma component to the blood source;
• 7) retaining a second portion of the red blood cell component and a second portion of the plasma component within the fluid circuit;
• 8) collecting the mononuclear cell component in the separation chamber over a plurality of cycles comprising steps 4 through 7, while anticoagulated whole blood enters the separation chamber continuously, at select intervals, and/or for a predetermined period of time;
• 9) pumping a volume of fluid comprising the mononuclear cell component and a third portion of the red blood cell component from the separation chamber at an MNC transfer rate;
• 10) directing the mononuclear cell component into a first container without the red blood cell component;
• 11) diluting the mononuclear cell component with a volume of the second portion of the plasma component within the fluid circuit pumped into the first container at a PRP rate;
• 12) adding a photoactivation agent to the mononuclear cell component to create an agent-added mononuclear cell component;
• 13) irradiating the agent-added mononuclear cell component to create a photoactivated mononuclear cell component;
• and
• 14) returning the photoactivated mononuclear cell component, the second portion of the red blood cell component, and/or the second portion of the plasma component;
• wherein the controller is configured to estimate throughout the procedure an end-of-procedure fluid balance based on the inputs of step 1, any priming fluid returned to the blood source in step 3, the volume of fluid in step 9, the MNC transfer rate in step 9, the volume of the second portion of the plasma component within the fluid circuit in step 11, and the PRP rate in step 11;
• wherein the controller is configured to provide a response action if the end-of-procedure fluid balance is above or below a programmed fluid balance range.