Abstract: A membrane separation device is disclosed along with systems and methods employing the device in blood processing procedures. In one embodiment, a spinning membrane separator is provided in which at least two zones or regions are created in the gap between the spinning membrane and the shell, such that mixing of the fluid between the two regions is inhibited by a radial rib or ridge associated with the spinning membrane that decreases the gap between the spinning membrane and the shell to define two fluid regions, the ridge isolating the fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously-collected whole blood into selected blood components, such as concentrated red cells and plasma, for collecting red cells and plasma directly from a donor in a single pass, and for cell washing. Data management systems and methods and priming methods are also disclosed.

Abstract: A computer-implemented method comprises providing a fluid circuit comprising fluid pathways configured to mount and associate with a durable processing device comprising a pressure sensor in communication with a controller and a fluid pathway. A container is connected to the pressure sensor and may receive a volume of fluid. A change in pressure values between a first and second time is measured from when the volume of fluid is not in communication with the pressure sensor to when the volume of fluid is in communication with the pressure sensor, the volume of fluid within the container or a presence or absence of a fluid connection to the fluid pathway based on the change in pressure values is determined, and a response action is executed if the volume of fluid within the container is not within an authorized volume range for the time period, or if a fluid connection is unauthorized.

Abstract: Method and apparatus are disclosed for mechanically opening a heat-bonded connection site between two hollow, flexible, thermoplastic segments of a medical fluid flow path, the heat-bonded connection site having an axis. The connection site is compressed between two facing surfaces, and the facing surfaces are relatively moved to rotate the connection site about the connection site axis and to apply force to the connection site substantially perpendicular to the connection site axis.

Abstract: System, apparatus and method for opening a heat-bonded connection formed between two hollow, flexible thermoplastic conduits. A pressure difference is created between the inside of at least one of the conduits and the ambient atmosphere sufficient to cause expansion of a wall of the tubing conduit in the vicinity of a frangible portion at least partially blocking the connection to disrupt the frangible portion and reduce the blocking.

Abstract: 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.

Abstract: Methods and systems for obtaining platelets are disclosed. Platelets are collected in a pre-determined volume of plasma and a determined amount of a combined storage medium including the pre-determined amount of plasma and a volume of a synthetic additive solution.

Abstract: A membrane separation device is disclosed along with systems and methods employing the device in blood processing procedures. In one embodiment, a spinning membrane separator is provided in which at least two zones or regions are created in the gap between the membrane and the shell, such that mixing of the fluid between the two regions is inhibited by a radial rib associated with the membrane that decreases the gap between the membrane and the shell to define two fluid regions, the ridge isolating the fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously collected whole blood into components, such as concentrated red cells and plasma, for collecting red cells and plasma directly from a donor in a single pass, and for cell washing. Data management systems and methods and priming methods are also disclosed.

Abstract: Red blood cell products and compositions are disclosed. The product includes a container made from PVC or a non-PVC material that is substantially free of a phthalate plasticizer but otherwise includes one or more non-phthalate plasticizers or extractable agents. The product includes a RBC concentrate which has been combined with an additive solution for storing the RBCs.

Abstract: A system for separating a suspension of biological cells is disclosed comprising a single-use fluid circuit and a durable hardware component. The fluid circuit comprises a separator having a housing that includes an inlet for introducing the suspension of biological cells into the gap, a first outlet in communication with the gap for flowing a first type of cells from the separator, and a second outlet in communication with the second side of the filter membrane for flowing a second type of cells from the separator.

Abstract: Methods for controlling a spinning membrane separator so as to limit fouling of the membrane by changing the rotation rate of the spinning membrane in response to the fouling rate, while maintaining a constant outlet cellular concentration. Increasing the spinner rotation rate will increase the strength of the Taylor vortices generated within the separator by the spinning of the membrane, which should reduce fouling of the membrane. The goal of the method is to rotate the spinning membrane at the slowest rate possible without unacceptable fouling. Two specific methods to control fouling are disclosed. In a first, unidirectional method, the spin rate of the membrane is only increased in response to undesirable fouling in order to prevent the fouling from continuing. In a second, bidirectional method, the spin rate of the membrane may be either increased or decreased in response to the measured fouling rate in order to maintain the fouling rate within a desired range.

Abstract: Fluid separation chambers are provided for rotation about an axis in a fluid processing system. The fluid separation chamber may be provided with first and second stages, with the first and second stages being positioned at different axial locations. In another embodiment, at least one of the stages may be provided with a non-uniform outer diameter about the rotational axis, which may define a generally spiral-shaped profile or a different profile for fractionating a fluid or fluid component. One or more of the stages may also have a varying outer diameter along the axis. The profile of the chamber may be provided by the chamber itself (in the case of rigid chambers) or by an associated fixture or centrifuge apparatus (in the case of flexible chambers).

Abstract: Methods and systems for obtaining platelets are disclosed. Platelets are collected in a pre-determined volume of plasma and a determined amount of a combined storage medium including the pre-determined amount of plasma and a volume of a synthetic additive solution.

Abstract: A cell processing system includes a first processor connectable to a source container filled with a biological fluid, a second processor, and a controller coupled to the processors. The first processor includes a separator configured to separate the biological fluid into at least two streams of material, and a first container configured to receive one of the streams. The second processor includes a magnetic separator configured to select target cells, the target cells being associated with magnetic particles, a second, pass-through container associated with the magnetic separator, the second container connected at a first end to the first container, and a third container connected to a second end of the pass-through container. One of the processors includes at least one pump configured to transfer material between the separator and the first container, and between the first container and the second container.

Abstract: Red blood cell products and compositions are disclosed. The product includes a container made from PVC or a non-PVC material that is substantially free of a phthalate plasticizer but otherwise includes one or more non-phthalate plasticizers or extractable agents. The product includes a RBC concentrate which has been combined with an additive solution for storing the RBCs.

Abstract: A device for pooling a blood component stored in source containers includes a pump or pumps configured to pump a fluid in a first direction and a second direction and receive a pump line having a first end connected to the source containers. A pool clamp is configured to receive a pool line having a first end connected to a second end of the pump line and a second end connected to a pool container. A wash clamp is configured to receive a wash line having a first end connected to the second end of the pump line and a second end connected to a wash media container. A controller is configured to open the pool clamp, close the wash clamp and operate the pump in the first direction and to alternatively close the pool clamp, open the wash clamp and operate the pump in the second direction.

Abstract: A variety of fill options is provided for a cell processing system. Certain options relate to a filling system associated with the cell processing system, the filling system comprising one or more filling stations, each with at least one container that may receive product from a container associated with a cell processing system. Other options relate to a syringe assembly that receives a product from a container associated with a cell processing system.

Abstract: A method and system for treating a biological fluid within a container by subjecting the container to light is provided. The system includes a fluid treatment chamber for receiving the container of biological fluid; an agitation assembly for oscillating the container of biological fluid within the fluid treatment chamber including a variable speed motor; one or more light sources in proximity to the fluid treatment chamber; at least one sensor for sensing a condition of the biological fluid in the container; and a programmable controller.

Abstract: Centrifuges are provided for rotating fluid separation chambers about an axis in a fluid processing system. The centrifuge may be provided with high- and low-G walls, with a gap defined between the high- and low-G walls. A first section of the gap may have a substantially uniform radius about the axis, while a second section of the gap may have a non-uniform radius about the axis. The radius of the second section of the gap about the axis at all locations is no larger than the radius of the first section of the gap about the axis. The high-G wall may comprise an inner surface of an outer bowl, while the low-G wall may comprise an outer surface of an inner spool. At least a portion of the second section of the gap may have a varying radius along the axis and/or be configured as a spiral.

Abstract: Systems and methods for performing a therapeutic red blood cell exchange procedure are disclosed. In one aspect, a system includes a first flow path for flowing whole blood from a patient. A separator communicates with the first flow path for separating at least red blood cells from plasma. Second and third flow paths communicate with the separator for respectively flowing the separated plasma and red blood cells from the separator. A flow controller is associated with the flow paths to control fluid communication between the flow paths. The controller is configured to perform the procedure to achieve a target fraction of patient cells remaining, target hematocrit, and a target patient fluid volume change at the completion of the procedure based on data input by the operator.

Abstract: Systems and methods for the washing and processing of biological fluid/biological cells are disclosed. The systems and methods utilize a disposable fluid circuit including a spinning membrane separation device to wash the biological cells.