Fenwal, Inc.

Other

Tanima Jahan Abedin

Katherine N Radwanski

Lan T Nguyen

Zahra R Ali

Kyungyoon Min

Christopher J Wegener

Jonathan W Prendergast

Molly Erickson

Korri Hershenhouse

Nicole F Young

Alaina Schlinker

Christian Bernard

Angela N Carlson

Greg Coultas

Brian C Nelson

Jacintha Sales

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

Methods and systems for treating a biological fluid with light are disclosed. The methods and systems include determining the light dose being delivered to a biological fluid and adjusting the duration of a treatment or the intensity of light emitted in the event of a detected light source outage.

Systems and methods for treating a biological fluid with light in the event of a bulb outage

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 method for prophylaxis or treatment of a graft's rejection of a recipient, driven and adjusted by a microprocessor-based controller. Provided is a fluid circuit comprising a first container configured to receive a transplant component and a second container configured to receive an apoptotic component. Provided is a separator configured to associate with the fluid circuit and separate whole blood into a red blood cell component, a plasma component, and a white blood cell component. Whole blood is directed into the fluid circuit and the separator. The whole blood is separated into the red blood cell component, the plasma component, and the white blood cell component. A first portion comprising the transplant component of the white blood cell component is directed to the first container. A second portion of the white blood cell component is directed to the second container and the second portion is rendered apoptotic.

System and method of collecting and infusing an apoptotic white blood cell component and a transplant component

A method is provided for removing red blood cells from a suspension comprising red blood cells, white blood cells, platelets and plasma using a spinning membrane separator. The method comprises: a) flowing whole blood into the gap of the spinning membrane separator; b) collecting red blood cells and white blood cells in the gap and passing plasma and platelets through the membrane; c) introducing a first quantity of lysing buffer into the gap; d) incubating the red blood cells, white blood cells and lysing buffer in the gap for a period of time to cause a lysis reaction with the red blood cells; e) introducing a second quantity of lysing buffer into the gap to displace the first quantity of lysing buffer and a first quantity of red blood cell debris out of the gap; f) introducing a first quantity of wash buffer into the gap to quench the lysis reaction and displace the second quantity of lysing buffer and a second quantity of red blood cell debris out of the gap; and g) introducing a second quantity of wash buffer into the gap to flow washed white blood cells out of the housing.

System and method to lyse and remove red blood cells from a cell product

Methods and systems for maintaining patient fluid balance during an extracorporeal cell treatment are disclosed. The method includes minimizing the amount of saline or other fluid that is returned to the donor. Saline used during priming of the fluid circuit may be used to increase the volume of the collected cells to arrive at a treatment-ready product with a suitable hematocrit.

Methods and systems for maintaining patient fluid balance during an extracorporeal therapeutic cell treatment

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

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

A system for collecting MNCs to be treated with irradiation comprises a fluid circuit comprising a product container for receiving a MNC product. The system comprises a separator to work in association with the fluid circuit, the separator comprising a chamber for separation into RBCs, plasma, and an interface carrying MNCs between the RBCs and the plasma. A microprocessor-based controller is in communication with the separator, wherein the controller receives input of a target hematocrit for the MNC product. The controller also receives input for a total volume of whole blood and a number of cycles, and directs the interface and a portion of the RBCs into the product container for a resulting product volume comprising a volume of MNCs and a volume of RBCs. The controller automatically adjusts a RBC volume so that a ratio of RBCs within the MNC product to MNC product equals the target hematocrit.

System for collecting mononuclear cells having a suitable hematocrit for extracorporeal photopheresis

Methods and systems for the treatment and post-treatment processing of a mononuclear cell product are disclosed. The methods and systems include and provide for the separation of excess conditioning fluid and unbound treating agent prior to return of said treated mononuclear cell product to a patient.

Methods and systems for processing and washing a photopheresis mononuclear cell product

A kit for blood component processing comprising a fluid circuit into which blood is drawn, wherein the fluid circuit comprises a plurality of pathways; wherein the first pathway is configured to receive blood drawn from a blood source and leads to a separation device, wherein the separation device is configured to separate the blood into components; wherein the second pathway is configured to receive a first component from the separation device and transport at least a portion of the first component to a first processing device, wherein the first processing device may alter the first component to produce a first output; and wherein the third pathway is configured to receive a second component from the separation device and transport at least a portion of the second component to a second processing device, wherein the second processing device may alter the second component to produce a second output.

Parallel processing of fluid components

Methods and systems are provided automatically removing air from a collection container for a blood product. The system comprises a disposable flow circuit including a tubing in fluid communication with the collection container and a durable hardware component. A programmable controller operates the pump in a first/forward direction to flow the target product into the collection container; determines that substantially all the target product has been pumped into the collection container; and operates the pump in the first/forward direction to pump a chase volume of air into the collection container along with any target product remaining in the tubing. In one embodiment, after the chase volume of air is pumped into the collection container, the controller operates the pump in a second/reverse direction for removing air from the collection container, and stops operation of the pump when the amount of air removed from the collection container is substantially equal to the residual volume of air.

Growing community of inventors

Chicago, IL, United States of America

Tanima Jahan Abedin