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: 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: The present disclosure relates to systems and methods for the separation of blood into blood products and, more particularly, to systems and methods that permit automated recovery of white blood cells after producing a leukocyte-reduced blood product.

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: 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 blood separation system is provided that includes a blood separation device that includes a centrifugal separator and a spinning membrane separator drive unit incorporated into a common case and a fluid flow circuit having both a separation chamber configured to be mounted in the centrifugal separator of the blood separation device and a spinning membrane separator configured to be received in the spinning membrane separator drive unit. In an exemplary procedure, the system is used to collect concentrated platelets and/or concentrated platelets and plasma, and to further permit harvesting of the mononuclear cells from the centrifugal separator at the conclusion of platelet collection, and transfer of the mononuclear cells to the spinning membrane separator.

Abstract: Systems and methods are provided for separating blood into two or more components for collection of red blood cells, plasma, or both red blood cells and plasma. 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, with the blood being separated into its constituents by the centrifugal separator. Separated plasma may be collected following separation by the centrifugal separator or may first be conveyed from the centrifugal separator into the spinning membrane separator drive unit to separate cellular blood components from the plasma prior to collection of the filtered plasma. The cellular blood components filtered from the plasma may be retained in the circuit as a waste product or may be flushed out of the circuit to a recipient.

Abstract: A fluid separation device includes a centrifuge in which a fluid is separated into at least two components, with an interface therebetween. At least a portion of one of the separated fluid components is removed from the centrifuge and flows through a vessel. Light is reflected off of the separated fluid component in the vessel and received and analyzed to determine its main wavelength. If the main wavelength is higher than a maximum value, a target location of the interface is changed. If the main wavelength is less than the maximum value, then the location of the interface is compared to the target location. When the interface is sufficiently close to the target location, the optical density of the separated fluid component in the vessel is compared to a minimum value. If the optical density is less than the minimum value, the target location of the interface is changed.

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: Blood from a blood source is drawn into a fluid flow circuit. A mononuclear cell product is separated from the blood, followed by at least a portion of the mononuclear cell product being conveyed into an electroporation device without disconnecting the blood source from the fluid flow circuit. The electroporation device opens pores in a membrane of at least one of the cells of the mononuclear cell product to allow DNA material (which is added to the mononuclear cell product prior to electroporation) to enter and modify the genome of the cell. At least a portion of the modified mononuclear cell product is returned to the blood source. The mononuclear cell product may be washed prior to being conveyed into the electroporation device. The modified mononuclear cell product may be washed after exiting the electroporation device.

Abstract: Blood in a separation chamber is separated into a red blood cell layer, a plasma constituent, and a mononuclear cell-containing layer. A portion of the plasma constituent exits the chamber via a plasma outlet, while a first portion of the red blood cell layer exits via a red blood cell outlet. A second portion of the red blood cell layer exits the chamber via the red blood cell outlet and is collected. At least a portion of the collected red blood cell layer may then be conveyed to the chamber via the red blood cell outlet to convey at least a portion of the mononuclear cell-containing layer out of the chamber via the plasma outlet for collection. A second portion of the plasma constituent may be conveyed out of the chamber via the plasma outlet to more fully collect the mononuclear cell-containing layer without the use of collected plasma.

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: 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: A fluid to be optically monitored may be optically mixed to modify the apparent color perceived by a colorimetric optical sensor device. The fluid is positioned within a fluid compartment of a vessel also including a contrast compartment adjacent to the fluid compartment. The contrast compartment is configured to have a contrast color with a known main wavelength that is different from the main wavelength of the fluid color. Light from a broadband light source of the colorimetric optical sensor device is reflected off of the vessel, with the received light being received by an optical spectrometer. The optical spectrometer analyzes the received light to determine a main wavelength of the received light, followed by a controller determining a characteristic of the fluid, which is based on the main wavelengths of the received light and the contrast color and the percentage of the vessel occupied by the fluid compartment.

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.