Abstract: An optical sensor device includes a light source configured to emit a light including a wavelength in a range of 650 to 900 nm that is exposed to a biological fluid at first and second times. At least a portion of the light is reflected off of the fluid and received by a light detector. The light detector analyzes at least a portion of the received light to determine a first intensity of the light at the wavelength at the first time and a second intensity of the light at the wavelength at the second time. A controller compares the first and second intensities and generates an output indicative of the presence of red blood cells or free hemoglobin in the biological fluid depending on which intensity is greater and whether there is more redness in the biological fluid at the first time or at the second time.

Abstract: A colorimetric optical sensor device includes a broadband light source configured to emit a light that is exposed to a fluid in a vessel. At least a portion of the light is reflected off of the fluid and received by an optical spectrometer. The optical spectrometer analyzes at least a portion of the received light to determine a main wavelength of the light. A controller correlates the main wavelength to a corresponding hematocrit or free hemoglobin concentration and generates an output indicative of the hematocrit or the free hemoglobin concentration of the fluid. The hematocrit or free hemoglobin concentration information may be used by a separation assembly in which the colorimetric optical sensor device may be incorporated to modify a separation procedure in which the monitored fluid is to be separated or is a component or constituent of a previously separated biological fluid.

Abstract: Systems and methods are provided for separating blood into two or more components. A blood separation system includes a blood separation device and a fluid flow circuit configured to be mounted to the blood separation device. The blood separation device includes a centrifugal separator and a spinning membrane separator drive unit incorporated into a common case, which allows for fluid separation by two different methods. Depending on the separation procedure to be carried out, the fluid flow circuit paired with the blood separation device may include only one separation chamber configured to be mounted to the centrifugal separator or spinning membrane separator drive unit or two separation chambers, with one being mounted to the centrifugal separator and the other to the spinning membrane separator drive unit. The system may be used to separate and collect any combination of red blood cells, plasma, and platelets.

Abstract: A system and method are provided for controlling fouling and complement protein activation during separation of plasma from whole blood using a spinning membrane separator. The separator includes a pair of relatively rotating surfaces spaced apart to define a gap therebetween, with at least one of the surfaces comprising a membrane that allows plasma to pass therethrough but substantially prevents the passage of red cells. In accordance with the method, the membrane material and membrane fabrication technique are selected so as that the resulting membrane both resists fouling and complement protein activation. In a specific embodiment, the membrane is has a smooth surface and substantially linear pores. The pores have a nominal diameter of less than 2 microns (so as to exclude platelets) and preferably a diameter of from 0.6 microns to 0.8 microns, as may be obtained by use of track-etching.

Abstract: A system for controlling a fluid procedure comprising a reusable separation apparatus controlled by a microprocessing controller. A sterile circuit is configured to associate with the reusable separation apparatus and provide a first fluid flow path in association with a pressure sensor in communication with the controller and a first pump configured to transmit pulsatile pressure signals to the pressure sensor during operation in association with the first fluid flow path. The reusable apparatus and the controller are configured to receive from the pressure sensor pressure signals comprising the pulsatile pressure signals, perform a frequency analysis of the pressure signals received by the pressure sensor over a time duration, derive a first rotation rate of the first pump or a first fluid flow rate at the first pump from the frequency analysis, and provide a response action based on the first rotation rate or the first fluid flow rate.

Abstract: A computer-implemented method for controlling fluid flow rates during a biological fluid procedure, comprising providing a membrane separator configured to separate a biological fluid into filtrate and retentate, wherein concentration of retentate exiting the membrane separator is controllable by altering a flow rate of the retentate exiting the membrane separator. The computer-implemented method also comprises detecting a change of attenuated retentate particles within the filtrate, comparing the change of attenuated retentate particles within the filtrate with a threshold level, and providing a response action comprising altering the concentration of retentate exiting the membrane separator if the change of attenuated retentate particles within the filtrate exceeds the threshold level.

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 method of separating blood into two or more components and subsequently washing a component, comprising providing a blood storage container containing an initial blood composition, and a blood separation circuit comprising a separator. The method also comprises separating and washing cellular material within the same blood separation circuit.

Abstract: A fluid flow circuit assembly for a fluid processing device, comprising a housing having a plurality of openings, a separator disposed at least partially within the housing, and a plurality of flow paths communicating between an interior and an exterior of the housing via the plurality of openings, wherein the separator is disposed substantially at the center of the plurality of flow paths.

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: 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: Systems and methods are provided for deriving a platelet product from a plurality of buffy coats. A plurality of buffy coats are separately collected, for example, using a conventional floor centrifuge. Plasma and/or a platelet additive solution may be added to the buffy coats. The buffy coats are pooled into a container and conveyed into a centrifuge or are sequentially conveyed into the centrifuge without being pooled, where they are continuously processed to separate platelets from the other cellular blood components. The separated platelets are conveyed out of the centrifuge as a platelet product, which may be passed through a leukocyte removal filter to reduce the white blood cell content of the platelet product. By continuously separating the buffy coats, fewer buffy coats are required to produce a single-dose platelet product, while also allowing for the derivation and collection of a plurality of single-dose platelet products.

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: 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: 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: A system and method are provided for controlling fouling and complement protein activation during separation of plasma from whole blood using a spinning membrane separator. The separator includes a pair of relatively rotating surfaces spaced apart to define a gap therebetween, with at least one of the surfaces comprising a membrane that allows plasma to pass therethrough but substantially prevents the passage of red cells. In accordance with the method, the membrane material and membrane fabrication technique are selected so as that the resulting membrane both resists fouling and complement protein activation. In a specific embodiment, the membrane is has a smooth surface and substantially linear pores. The pores have a nominal diameter of less than 2 microns (so as to exclude platelets) and preferably a diameter of from 0.6 microns to 0.8 microns, as may be obtained by use of track-etching.

Abstract: A system and method are provided, including an integrated single-use kit, for processing whole blood to produce platelet rich plasma. A two stage spinning membrane separator, has a first stage for receiving whole blood and separating substantially all red blood cells from plasma and platelets, and a second stage for further separating platelet rich plasma from plasma. A first waste container is in fluid communication with the first stage of the separator for receiving separated red blood cells, while a second waste container is in fluid communication with the second stage of the separator for receiving separated plasma. An outlet line is in fluid communication with the second stage of the separator for receiving platelet rich plasma, and a reinfusion container is removably connected to the outlet line for receiving platelet rich plasma from the second stage of the separator.