Fenwal, Inc.

Zahra R Ali

Lan T Nguyen

Tanima Jahan Abedin

Katherine N Radwanski

Molly Erickson

Korri Hershenhouse

Angela N Carlson

Kyungyoon Min

Jonathan W Prendergast

Nicole F Young

Christopher J Wegener

Christian Bernard

David Edward Stude

Brian C Nelson

Christian R Bernard

Fluid processing assemblies and methods are provided for mononuclear cell collection. Mononuclear cells are separated from red blood cells in a blood separation chamber, with the mononuclear cells and then the red blood cells exiting the chamber via an outlet port. The mononuclear cells and then the red blood cells enter an outlet flow path that is in fluid communication with a mononuclear cell collection container. The outlet flow path includes a visual indicium, which an operator may use to determine the position of the red blood cells within the outlet flow path and when to end mononuclear cell collection by preventing fluid communication between the outlet flow path and the mononuclear cell collection container.

Systems and methods for collecting mononuclear cells

Described is a method for controlling fluid volume balance. A controller is configured with a first set of inputs comprising a hematocrit, a total blood volume, and an ACD ratio. A maximum extracorporeal RBC amount during the procedure is estimated based on the first set of inputs. A fluid circuit is primed with a priming fluid. Whole blood is drawn from a blood source and separated into a RBC component, a target cell component, and a plasma component. The target cell component is directed to a product container. The product container comprising the target cell component is treated. A treated target cell component, a portion of the RBC component remaining in the fluid circuit, and/or a portion of the plasma component remaining in the fluid circuit are returned to the blood source. A first response action is provided if the maximum extracorporeal RBC amount estimated is above a programmed limit.

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

Methods and systems for sampling blood components in a photopheresis procedure are disclosed. The methods include collecting samples at selected times during a photopheresis procedure.

Methods and systems for collecting samples in a photopheresis procedure

A processing system includes a processor including a separator, a set configured to cooperate with the separator to separate whole blood into plasma and other components, the set including an inlet line attachable to a patient to receive whole blood and an return line attachable to a patient to return processed fluid, and a source of replacement fluid connected to the disposable set, the processor configured to combine the other components with replacement fluid to define the processed fluid. The processor includes a controller and an input device coupled to the controller, the controller configured to receive an input via the input device, the input representing a volume of replacement fluid, and to control the processor to separate whole blood passing through the set and to combine the other components with the replacement fluid according to the input until the source of replacement fluid is empty.

System and methods incorporating replacement fluid maximization

Mid-procedure termination of a mononuclear cell collection procedure may prevent collection of an amount of red blood cells that is required to harvest a complete mononuclear cell product. Blood separation systems and methods are provided for minimizing the impact of or recovering from mid-procedure termination of such a mononuclear cell collection procedure. According to one approach, blood or separated red blood cells are conveyed into a red blood cell collection container relatively early in the procedure to minimize the impact of a later termination of the procedure. According to another approach, blood and/or separated red blood cells within a fluid processing assembly are redirected through the fluid processing assembly following mid-procedure termination to allow for at least partial mononuclear cell collection. According to yet another approach, a double-needle fluid processing assembly may be converted into a single-needle configuration to allow for continued processing following mid-procedure termination.

Collection of mononuclear cells upon mid-procedure termination

An extracorporeal photopheresis system includes a separator with a disposable fluid circuit including a treatment container, an irradiation device configured to treat the contents of the treatment container, and a controller configured to control the system to perform a procedure including drawing anticoagulated whole blood into the fluid circuit from a blood source and returning to the blood source a treated target cell component, a portion of a red blood cell component remaining in the fluid circuit, and/or a portion of a plasma component remaining in the fluid circuit. The controller is further configured to estimate an end-of-procedure fluid balance estimated based on manual or automatic inputs including a patient body weight associated with the blood source and a total blood volume of the blood source, indicate the fluid balance to an operator, and receive one or more changes that affect the fluid balance after indicating the fluid balance.

Systems and method for verifying the timely placement of a container of biolocal cells or fluid within a treatment chamber of a biological fluid treating device are disclosed. The systems and methods utilize a sensor that detects the presence of a container at an appropriate and pre-determined time and, optionally, detects the weight of the container and cells.

Systems and methods for verifying that a biological product is ready for treatment

A computer-implemented method for approving a medical device disposable component used in a medical procedure comprising providing an identifiable feature on a medical device disposable component, wherein the identifiable feature comprises one or more photo-identifiable entities having a first emission pattern when in an unexcited state and a second emission pattern when in an excited state. The method also comprises illuminating the identifiable feature with an excitation light source to elicit the second emission pattern, detecting the second emission pattern and comparing the second emission pattern against a set of established reference emission patterns, and determining whether the medical device disposable component is approved based on comparison of the second emission pattern to the set of established reference emission patterns.

System and method for authenticating medical device disposable components

Systems and methods for performing online extracorporeal photopheresis of mononuclear cells are disclosed. During a mononuclear cell collection cycle, blood is removed from a source and separated into a plasma constituent, a mononuclear cell-containing layer, and red blood cells, followed by the collection of a pre-product including at least a portion of the mononuclear cell-containing layer and at least a portion of the separated red blood cells. The mononuclear cell collection cycle may be repeated, followed by the production of a single mononuclear cell product using the collected pre-product(s). The mononuclear cell product is irradiated using a fixed dose of light, such that the mononuclear cell product is produced so as to have a predetermined volume and a predetermined hematocrit, regardless of the number of pre-products used to produce the mononuclear cell product. Following irradiation, at least a portion of the irradiated mononuclear cell product is returned to the source.

Systems and methods for performing online extracorporeal photopheresis

Blood separation systems and methods are provided for separating blood under conditions of reduced plasma clarity. The system may assess plasma clarity by monitoring light transmissivity of plasma or comparing an actual plasma flow rate to an ideal plasma flow rate, with a low flow rate indicating decreased clarity, which may be addressed by increasing the plasma flow rate. For extracorporeal photopheresis, plasma clarity may be a factor in determining the dosage of irradiating light to apply to mononuclear cells. A fluid processing assembly for mononuclear cell collection may include visual indicium, which an operator may use to determine when to end mononuclear cell collection. The system may detect red blood cells flowing toward a mononuclear cell collection container and reverse the direction of flow to prevent red blood cells from entering the container. An operator may also be enabled to selectively begin and/or end harvesting of mononuclear cells.

Systems and methods for separating blood under conditions of reduced plasma clarity

Convertible fluid processing assemblies

A medical device verification system for an extracorporeal photopheresis procedure comprises a reusable irradiation device comprising a UV light source and a scanner. A fluid circuit comprises a disposable cell suspension container having a photo-reactive label comprising an identifiable code. The identifiable code is unobscured when the label in a first state and is obscured when the label is in a second state. The irradiation step is performed by irradiating the disposable cell suspension container for a predetermined period of time at or above the threshold UV irradiation level. A second input is received from the scanner during the irradiation step, the second input comprising identification of a state of the label. A response action is provided if the first input comprises identification of the second state of the label and/or if the second input comprises identification of the first state of the label.

System and method for authenticating disposable components in extracorporeal photopheresis

Systems and methods are provided for depleting platelets from blood. The system includes a multi-stage blood separation chamber in which blood is separated into red blood cells and platelet-rich plasma. The platelet-rich plasma is conveyed from a first stage of the chamber to a second stage, where it is separated into platelets and platelet-poor plasma. The platelet-poor plasma is conveyed out of the chamber while the platelets are allowed to accumulate in the second stage of the chamber. When a controller of the system has determined that the maximum chamber capacity of platelets has been accumulated in the second stage of the chamber, the platelets are conveyed out of the chamber to a waste container. The cycle of separating blood into its components, accumulating platelets in the chamber, and then flushing the platelets from the chamber is repeated until a target platelet concentration of the blood is achieved.

Growing community of inventors

Chicago, IL, United States of America

Zahra R Ali