Fenwal, Inc.

Lan T Nguyen

Brian C Case

Jonathan W Prendergast

John T Foley

Zahra R Ali

Kyungyoon Min

Katherine N Radwanski

Daniel R Boggs

Tanima Jahan Abedin

Samantha M Planas

Amit J Patel

Walter T Watts

Angela N Carlson

Molly Erickson

Korri Hershenhouse

Matthew J Schoonover

John W Barry

Jeffrey Maher

Greg Coultas

Nicole F Young

Christopher Mikkelson

Christopher J Wegener

Tony Nguyen

Christian Bernard

David Edward Stude

Elizabeth Nelson

Kevin Schalte

Yamen Alshawaf

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

Systems and methods are disclosed for performing online extracorporeal photopheresis in which the needs of a particular patient as to the fluid balance to be achieved and the time allotted to perform the procedure can be prioritized. Whole blood is removed from a patient and introduced through a processing set into a separation chamber to separate the desired cell population from the blood. The separated cell population is processed through the set which is associated with a treatment chamber where the cells are treated. Once treated, the cells are returned to the patient.

Systems and methods for performing extracorporeal photopheresis

A system and method for collecting plasma includes drawing whole blood from a donor, combining anticoagulant with the whole blood from the donor, separating the whole blood into a plasma product and a second blood component and sending the plasma product to a collection container. A controller determines a total blood volume for a donor based on donor weight, height and gender. The system comprises a touchscreen for receiving a confirming user input and a scanning device configured to scan a bar code associated with a donor. The system and method operate a plurality of draw and return phases.

Plasma collection

Blood treatment systems and methods are provided for combining a blood separation system and an adsorption device. The blood separation system is configured to separate a blood component from blood, while the adsorption device is configured to receive at least a portion of the separated blood component and process it. The blood separation system includes a fluid flow element and a controller. The fluid flow element is configured for flowing the separated blood component into the adsorption device. The controller controls the fluid flow element based at least in part on one or more processing parameters. The processing parameters include a maximum flow rate of the separated blood component flowed into the adsorption device, a maximum pressure of the separated blood component flowed into the adsorption device, and/or the volume of fluid in a location of the system.

Systems and methods for use and control of an automated separator with adsorption columns

Methods and systems for treating a biological fluid with light are disclosed. The methods and systems provide for determining a target light dose for the biological fluid; loading a treatment container holding the biological fluid into an irradiation chamber of an irradiation device comprising: with the treatment container being supported in the irradiation device in between a first array of light sources and first light energy sensors and a second light energy sensor. The first array of light sources is activated, and a first light intensity is measured with the first light energy sensors. A second light intensity is measured with the second light energy sensor, and the first light intensity is compared to the second light intensity to determine an attenuation factor. The attenuation factor is applied to the first light intensity to determine a time to achieve the target light dose, with the first array of multiple light sources being deactivated after the time to achieve the target light dose has elapsed.

Systems and methods for photoactivation of a biological fluid

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

A system and method for collecting plasma includes drawing whole blood from a donor, combining anticoagulant with the whole blood from the donor, separating the whole blood into a plasma product and a second blood component and sending the plasma product to a collection container. A controller receives parameters over a network from a remote computer, receives a user input to confirm the a parameter and/or procedure, determines a target volume for plasma product and/or raw plasma based on the parameters and, in response to confirming the donor, controls the system to collect the plasma using draw and return phases.

Plasma collection with remote programming

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

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.

An apparatus and method for the batch photoactivation of mononuclear cells (MNCs) is described. The system includes a programmable controller configured to automatically separate whole blood in a first collection cycle to obtain a first quantity of MNCs; separate whole blood in a second collection cycle to obtain a second quantity of MNCs while simultaneously photoactivating the first quantity of MNCs to obtain a first quantity of treated MNCs; either store the first quantity of treated MNCs or reinfuse the first quantity of treated MNCs; photoactivate the second quantity of MNCs to obtain a second quantity of treated MNCs; either store the second quantity of treated MNCs or reinfuse the second quantity of treated MNCs; and reinfuse any blood components remaining after the second collection cycle.

Apparatus and method for batch photoactivation of mononuclear cells

A method of collecting mononuclear cells includes separating plasma from cellular components of whole blood. The cellular components, which include mononuclear cells and red blood cells, are combined with plasma replacement fluid to form a first mixture. The mononuclear cells of the first mixture are separated from the red blood cells of the first mixture, which may be followed by extracorporeal photopheresis being performed on the mononuclear cells.

System and method for plasma purification prior to mononuclear cell collection

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.

Growing community of inventors

Vernon Hills, IL, United States of America

Lan T Nguyen