Abstract: 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.

Abstract: A blood treatment apparatus is disclosed. In an example, the blood treatment apparatus includes a blood treatment unit; a blood line configured to extract blood from a blood source, pass the blood through the blood treatment unit and deliver treated blood to a target vessel; and a fluid line configured to pass treatment fluid through the blood treatment unit and deliver used treatment fluid to a fluid sink. A flow divider is arranged in the fluid line for separating treatment fluid into to a first fluid section and a second fluid section, thereby electrically isolating the fluid sections such that electrical current flowing in the fluid line between the fluid sections is limited. Related manufacturing and verification methods are also described.

Abstract: A device for filtration of fat extracted during liposuction procedures. The device includes: a first reservoir filled with a physiological solution adapted to be suctioned by a syringe containing fat mixed with blood and anesthetic; a second reservoir, empty, intended to receive cyclically from the syringe a liquid mixture consisting of the suctioned solution, blood and anesthetic separated from the fat; and at least one filter element provided with a connection member for connection of the syringe, the filter element being connected to the first reservoir and the second reservoir through a three-way connector. A first one-way valve configured to allow passage of a flow of fluid from the first reservoir towards the connector is arranged on a branch of the connector connected to the first reservoir. A second one-way valve configured to allow passage of a flow of fluid from the connector towards the second reservoir is arranged on a branch of the connector connected to the second reservoir.

Abstract: A whole blood filtration device is provided with a filter membrane separating a feeding volume and a clean side of the filter membrane from each other. The feeding volume communicates with a first feeding side opening and with a second feeding side opening. The filter membrane has pores with a pore size that ensures permeability of the filter membrane to blood plasma/serum and that retains blood cells. The first feeding side opening can be coupled to a first blood pump for feeding blood from the first feeding side opening into the feeding volume so that blood plasma/serum permeates the filter membrane and blood cells, retained by the filter membrane, exit from the feeding volume through the second feeding side opening.

Abstract: 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.

Abstract: Devices for the removal of cells or other particles from a biological fluid are disclosed. The devices include a removal medium housed within a chamber of a housing. The devices include inlet and outlet ports carried by the walls. One or both of the ports includes a flow path portion having a chamber-communicating portion that has a cross-section that is larger than the cross-section of an adjacent flow path portion.

Abstract: The present disclosure provides systems, devices, and methods for purifying microorganism nucleic acid from a host sample, such as a whole blood sample from a human. In certain embodiments, devices and systems with multiple filters are employed and provide for the selective removal of blood cells and host nucleic acids from a sample in order to enrich for microorganism nucleic acid.

Abstract: A device for transporting waste gases and liquid exudates from a wound. The device may include a multi lumen tubing and a connector for securing the multi lumen tubing to a fitting. The multi lumen tubing may include a double wall containment structure with a first lumen and a second lumen. The connector may include a body with a first cavity on one side, a second cavity on another side, and an interior wall located between the first cavity and the second cavity. The interior wall may form a projection in the second cavity. The projection may include an outer surface and a ledge adjacent the outer surface. The projection may cooperate with the multi lumen tubing to form a liquid-gas separator. The ledge may include a bore extending between the first cavity and the second cavity. The bore may house a gas permeable and a liquid impermeable barrier.

Abstract: An anti-cancer substance is administered via the patient's blood ex vivo and in line by establishing a connection between the patient and a device having a chamber containing the anti-cancer substance. The patient's blood in the chamber and the anti-cancer substance interact so that immune cells in the blood (1) are activated to produce an immune response in the patient, or (2) are pre-armed by attaching to the cells antibodies, or (3) both. After activating or pre-arming the cells, the patient's treated blood is returned to the patient. The anti-cancer substance may be within the chamber prior to drawing the patient's blood into the chamber, may be introduced into the chamber after drawing the patient's blood into the chamber, or may be introduced into the chamber concurrent with the introduction of the patient's blood into the chamber. The connection is terminated after returning to the patient's blood including the activated or pre-armed cells.

Abstract: Certain examples describe systems and methods for increasing plasma extracted from donor blood. An example method includes receiving blood extracted from a donor connected to a blood collection machine. The example method includes filtering the blood using a filtration device to remove at least a portion of plasma included in the blood to separate the plasma removed from remaining blood. The example method includes routing the plasma removed for collection. The example method includes re-filtering the remaining blood using a or the filtration device to remove additional plasma from the remaining blood. The example method includes routing the additional plasma removed for collection.

Abstract: This invention provides an apparatus and methods to consistently separate and concentrate selected blood components. The system includes, e.g., a computerized fluid handling system to transfer blood components between a centrifugal blood separation disc, containers and a concentrator.

Abstract: Apparatus for contacting body fluids with the bio-affinity material is disclosed. The apparatus includes a container having top and bottom lock covers that clip onto the container.

Abstract: A method for the re-anticoagulation of platelet rich plasma in a blood apheresis system includes priming the blood apheresis system with anticoagulant, such that a volume of anticoagulant is transferred to a PRP container. The method may then transfer the anticoagulant within the PRP container to a red blood cell container, and collect a volume of platelet rich plasma within the PRP container. The platelet rich plasma may be collected in a plurality of cycles. Between collection cycles, the method may transfer a portion of the volume of anticoagulant from the red blood cell container to the PRP container.

Abstract: A method and apparatus for collecting plasma reduced platelets potentially suspended in a synthetic solution from a donor. Whole blood is drawn from the donor and introduced into a separation chamber. Platelets are extracted from the separation chamber into a container, using, for example, surge (with anticoagulated plasma or a synthetic solution) or push methodologies. The remaining blood components in the separation chamber are returned back to the donor. The steps of drawing whole blood and introducing the whole blood into the separation chamber, extracting platelets from the separation chamber into the container, and returning the remaining components in the chamber back to the donor are repeated. The sequestered platelets in the container are reintroduced into the separation chamber, whereupon a plasma reduced platelet product is extracted.

Abstract: Permselective asymmetric membranes suitable e.g. for hemodialysis, hemodiafiltration and hemofiltration of blood, and having improved performance, including improved sieving characteristics, providing enhanced removal of middle molecular weight substances, e.g. inflammatory mediators having a molecular weight between 20 and 40 kDa. The improved sieving characteristics are due to a narrow pore size distribution of the membranes created in the production process. Processes for the preparation of these membranes, devices comprising these membranes, and the use of these membranes in hemodialysis, hemodiafiltration and hemofiltration of blood, as well as in bioprocessing, plasma fractionation and the preparation of protein solutions.

Abstract: The invention is directed to the removal of serum gal-3 from circulation by plasmapheresis using gal-3 binding agents in either a fixed bed, or in a form easily removed, such as by being complexed with magnetic particles. This method, on its own, brings a sharp reduction and relief from the inflammation and fibroses that can be induced by circulating gal-3. The process may be combined with the administration of gal-3 binding agents, such as modified citrus pectin, to further lower unbound gal-3 levels, to the point where gal-3 in the tissues may be addressed. This method may also be combined with removal of TNF receptors to provide an effective treatment for cancer.

Abstract: Provided herein are, inter alia, methods of diagnosing and treating autoimmune cardiomyopathy in subjects, based upon the detection of IgG4 antibodies to cardiac autoantigens.

Abstract: A blood processing device includes a venous-access device, a blood component separation device, a return line, a draw line, a first pressure sensor, a second pressure sensor, and a first pump. The first pressure sensor is located on the return line between the blood component separation device and the venous-access device, and determines a first pressure. The second pressure sensor is located on the draw line between the blood component separation device and the venous-access device, and determines a second pressure. The first pump is connected to at least one of the return line and the draw line and controls a flow rate within the connected line based on a subject access pressure determined based upon the first and second pressures.

Abstract: A blood processing device includes a venous-access device, a blood component separation device, a return line, a draw line, a first pressure sensor, a second pressure sensor, and a first pump. The first pressure sensor is located on the return line between the blood component separation device and the venous-access device, and determines a first pressure. The second pressure sensor is located on the draw line between the blood component separation device and the venous-access device, and determines a second pressure. The first pump is connected to at least one of the return line and the draw line and controls a flow rate within the connected line based on a subject access pressure determined based upon the first and second pressures.

Abstract: An access disconnect system includes a blood processing machine having a blood pump operable with blood tubing, first and second conductive contacts located in the blood tubing on an arterial tubing side of a blood filter. The first conductive contact is located upstream of the blood pump and the second conductive contact is located downstream of the blood pump. The first and second conductive contacts are positioned and arranged to form a conductive circuit including a vascular system of a patient and the blood processing machine. The system further includes a source of electric current connected to at least one of the first and second conductive contacts and a transmitter for sending a signal indicative of an amount of current flowing through the conductive circuit when the source of electric current is applied.

Abstract: Disclosed is an apparatus that allows for separating and collecting a fraction of a sample. The apparatus, when used with a centrifuge, allows for the creation of at various fractions in the apparatus. A buoy system that may include a first buoy portion and a second member operably interconnected may be used to form at least three fractions from a sample during a substantially single centrifugation process. Therefore, the separation of various fractions may be substantially quick and efficient. Also selected fractions from the sample can be applied to a patient, either alone or as part of a mixture.

Abstract: A method and device for treating cholesterol disorders includes administering at least one treatment regime including two or more rounds of plasmapheresis to a patient having abnormal total cholesterol, abnormal LDL levels and/or abnormal HDL levels prior to treatment. Treatment according to the method results in decreased LDL levels in patients having abnormal LDL levels and increased HDL levels in patients having abnormal HDL levels. Each subsequent round of plasmapheresis is conducted weekly, but no more than twice per week.

Abstract: Provided herein are, inter alia, methods of diagnosing and treating autoimmune cardiomyopathy in subjects, based upon the detection of IgG4 antibodies to cardiac autoantigens.

Abstract: A membraneless separation device can be applied to a variety of treatments, such as the ultrafiltration of blood for a patient with end stage renal disease. An ultrafiltration device can include a membraneless separation device, which separates an incoming blood flow into a substantially cytoplasmic body-free plasma flow and remaining fraction, and a dialysate-free second stage, which selectively removes excess fluid, toxins and other substances from the plasma flow and returns the processed plasma to the membraneless separation device. A treatment protocol can include ultrafiltering blood of a patient using the ultrafiltration device and performing a secondary treatment on the blood of the patient at a reduced frequency compared to the ultrafiltering. The membraneless separation device can also be applied to treatment, analysis, and/or exchange of plasma from blood, or combined with conventional dialyzers to perform dialysis on a cytoplasmic body-free plasma fraction.

Abstract: Devices, systems and methods are disclosed for removing undesirable materials from a sample fluid by contact with a second fluid. The sample fluid flows as a thin layer adjacent to, or between, concurrently flowing layers of the second fluid, without an intervening membrane. In various embodiments, a secondary separator is used to restrict the removal of desirable substances and effect the removal of undesirable substances from blood. The embodiments may be used for the removal of components from a sample fluid that vary in size. When blood is the sample fluid, for example, this may include the removal of small molecules, middle molecules, macromolecules, macromolecular aggregates, and cells, from the blood sample to the extractor fluid.

Abstract: Centrifuges are useful to, among other things, remove red blood cells from whole blood and retain platelets and other factors in a reduced volume of plasma. Platelet rich plasma (PRP) can be obtained rapidly and is ready for immediate injection into the host. Embodiments may include valves, operated manually or automatically, to open ports that discharge the excess red blood cells and the excess plasma while retaining the platelets and other factors. High speeds used allow simple and small embodiments to be used at the patient's side during surgical procedures. The embodiments can also be used for the separation of liquids or slurries in other fields such as, for example, the separation of pigments or lubricants.

Abstract: Certain examples describe systems and methods for increasing plasma extracted from donor blood. An example method includes receiving blood extracted from a donor connected to a blood collection machine. The example method includes filtering the blood using a filtration device to remove at least a portion of plasma included in the blood to separate the plasma removed from remaining blood. The example method includes routing the plasma removed for collection. The example method includes re-filtering the remaining blood using a or the filtration device to remove additional plasma from the remaining blood. The example method includes routing the additional plasma removed for collection.

Abstract: A method and apparatus for collecting plasma reduced platelets potentially suspended in a synthetic solution from a donor. Whole blood is drawn from the donor and introduced into a separation chamber. Platelets are extracted from the separation chamber into a container, using, for example, surge (with anticoagulated plasma or a synthetic solution) or push methodologies. The remaining blood components in the separation chamber are returned back to the donor. The steps of drawing whole blood and introducing the whole blood into the separation chamber, extracting platelets from the separation chamber into the container, and returning the remaining components in the chamber back to the donor are repeated. The sequestered platelets in the container are reintroduced into the separation chamber, whereupon a plasma reduced platelet product is extracted.

Abstract: A centrifuge for separating blood having a camera observing fluid flow, and a controller controlling the flow. The location of an interface is detected by image processing steps, which may comprise the steps of “spoiling” the image, “diffusing” the image, “edge detection”, “edge linking”, “region-based confirmation”, and “interface calculation”. “Spoiling” reduces the number of pixels to be examined preferentially on orthogonal axis oriented with respect to the expected location of the interface or phase boundary. “Diffusing” smoothes out small oscillations in the interface boundary, making to the location of the interface more distinct. “Edge detection” computes the rate of change in pixel intensity. “Edge linking” connects adjacent maxima. “Region-based confirmation” creates a pseudo image of the regions that qualify as distinct. “Final edge calculation” uses the points where the shade changes in the pseudo image, averages the radial displacement of these points for the interface position.

Abstract: An anti-MHC removal device includes a serologically active, soluble MHC moiety covalently coupled to a solid support. Methods of production include covalently coupling the serologically active, soluble MHC moiety to the solid support. Methods of use of the anti-MHC removal device include contacting a biological sample with the device so that antibodies specific for the MHC moiety are removed from the biological sample. The biological sample is then recovered.

Abstract: This invention is directed to a method of collecting and separating whole blood into components. The method includes the steps of adding an anticoagulant having an acidic pH to a bag for collecting and/or separating whole blood, collecting whole blood in the bag, loading the bag containing anticoagulated whole blood on a rotor, spinning the bag on the rotor to separate the whole blood into at least one component; and squeezing the bag on the rotor to push the component from the separation bag into at least one satellite bag.

Abstract: The invention relates to a method for diagnosis of multiple sclerosis (MS) wherein, presence or absence of an anti-AT1 receptor antibody is determined in a sample from a patient to be diagnosed and wherein, the presence of an anti-AT1-receptor antibody is indicative of the disease.

Abstract: This invention provides an apparatus and methods to consistently separate and concentrate selected blood components. The system includes, e.g., a computerized fluid handling system to transfer blood components between a centrifugal blood separation disc, containers and a concentrator.

Abstract: In some embodiments, a method to detect acute rejection in allograft from is described. In some embodiments, a method to anticipate an episode of acute rejection in allografts is also described. In some embodiments, a kit for detecting or predicting acute transplant rejection of a transplanted organ is described.

Abstract: A centrifuge for separating blood having a camera observing fluid flow, and a controller controlling the flow. The location of an interface is detected by image processing steps, which may comprise the steps of “spoiling” the image, “diffusing” the image, “edge detection”, “edge linking”, “region-based confirmation”, and “interface calculation”. “Spoiling” reduces the number of pixels to be examined preferentially on orthogonal axis oriented with respect to the expected location of the interface or phase boundary. “Diffusing” smoothes out small oscillations in the interface boundary, making the location of the interface more distinct. “Edge detection” computes the rate of change in pixel intensity, or. “Edge linking” connects adjacent maxima. “Region-based confirmation” creates a pseudo image of the regions that qualify as distinct. “Final edge calculation” uses the points where the shade changes in the pseudo image, averages the radial displacement of these points for the interface position.

Abstract: A single use, sterile, self-contained, compact, easy to use centrifugal separation unit provides for quick, reliable platelet concentration from whole blood. Anti-coagulated blood is injected through an elastomeric seal into a separation chamber featuring a tapered barrel and an end cap. At least one port is located in the end cap, at a desired radius from the longitudinal axis. The centrifugal field created by rotation of the chamber stratifies the blood radially, with red blood cells adjacent the wall of the barrel, and plasma found closest to the longitudinal axis. Opening the port causes the pressure of the centrifugal field to eject red blood cells or plasma, thereby increasing the concentration of platelets remaining in the chamber. After ceasing chamber rotation, the concentrated platelets are recovered.

Abstract: A separation device including a first buoy, a second buoy, a first valve, and a second valve. The first buoy is mounted to a buoy guide post and slidably mounted within a separation chamber. The second buoy is slidably mounted to the guide post and movable between a first position and a second position. The second buoy closes the first valve and opens the second valve when in the first position. The second buoy opens the first valve and closes the second valve when in the second position. The second buoy has a density such that after spinning the device for a suitable period of time a first component of the composition is isolated between the first buoy and the second buoy and a second component of the composition is isolated between the second buoy and the end of the separation chamber that is opposite to a port.

Abstract: Artificial kidney for gradual, and at least semi-continuous, blood treatment, wherein a blood stream is fed from a body of a living human or animal being into the artificial kidney, where anticoagulation is first effected, blood cells and molecules of large and medium molecular weight, such as proteins, are then primarily separated from plasma and fed back to the blood stream, regulating a water and salt balance by diverting excess plasma water and further removing from the blood stream, plasma or plasma water accumulated and toxic substances, by removal of specific electrolytes and waste products and wherein purified or partially purified plasma and plasma water is being carried back to the blood tract of the body.

Abstract: Certain examples describe systems and methods for increasing plasma extracted from donor blood. An example method includes receiving blood extracted from a donor connected to a blood collection machine. The example method includes filtering the blood using a filtration device to remove at least a portion of plasma included in the blood to separate the plasma removed from remaining blood. The example method includes routing the plasma removed for collection. The example method includes re-filtering the remaining blood using a or the filtration device to remove additional plasma from the remaining blood. The example method includes routing the additional plasma removed for collection.

Abstract: A process for detoxifying the blood of a patient in need thereof involves: collecting albumin from human plasma and/or plasma fractions; diafiltration of a mixture containing the collected albumin; stabilizing the resulting diafiltered albumin mixture with sodium chloride and an amino acid in the absence of any added fatty acid; pasteurizing the stabilized albumin mixture; diafiltering the pasteurized mixture to remove, among other things, stabilizers; and detoxifying the blood of the patient by administering the resulting albumin to the patient. In one embodiment, the amino acid stabilizing agent is acetyl tryptophan. The resulting albumin has at least about 80% albumin binding capacity relative to natural plasma albumin, and is storage stable for about 30 months at 30° C.

Abstract: A novel system and method for fluid management for accurate continuous venovenous hemofiltration (CWH) in extracorporeal membrane oxygenation (ECMO). The fluid management or CWH system is automated and configured for operation as a stand alone unit and can be easily integrated with an ECMO system. The fluid management system is capable of producing either perfect or negative fluid balance between ultrafiltrate removal and replacement fluid delivery. The fluid management system can achieve electrolyte replacement over a range of flow rates needed to care for patients ranging from neonates to adults. Finally, the novel fluid management system preserves patient safety, maintains sterility during operation, is easy to operate, and is compact enough to fit near a patient's bed.

Abstract: Method and apparatus for separating plasma from blood in a membrane separator and further separator the separated plasma into desired plasma proteins in a plasma separator fluidly connected to the membrane separator to receive the separated plasma.

Abstract: A method to treat cancer uses ultrapheresis, refined to remove compounds of less than 120,000 daltons molecular weight, followed by administration of replacement fluid, to stimulate the patient's immune system to attack solid tumors. In the preferred embodiment, the patient is ultrapheresed using a capillary tube ultrafilter having a pore size of 0.02 to 0.05 microns, with a molecular weight cutoff of 120,000 daltons, sufficient to filter one blood volume. The preferred replacement fluid is ultrapheresed normal plasma. The patient is preferably treated daily for three weeks, diagnostic tests conducted to verify that there has been shrinkage of the tumors, then the treatment regime is repeated. The treatment is preferably combined with an alternative therapy, for example, treatment with an anti-angiogenic compound, one or more cytokines such as TNF, gamma interferon, or IL-2, or a procoagulant compound. The treatment increases endogenous, local levels of cytokines, such as TNF.

Abstract: A method for batch implementation of settings in a renal replacement therapy device including: displaying on a user interface control settings which may be manually selected by an operator; selecting an independent control setting of the plurality of control settings; adjusting the independent control setting to an independent control setting level selected by an operator; temporarily storing the adjusted independent control setting level; automatically adjusting a dependent control setting level based upon the independent control level; displaying the adjusted independent control setting level and the adjusted dependent control setting, and implementing both the adjusted independent control setting level and the adjusted dependent control setting to control the device, by actuating a batch setting acceptance operation.

Abstract: Systems and methods for controlling hematocrit during a blood processing procedure. 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 second and third flow paths to control fluid communication between the second and third flow paths and addition of separated plasma to the separated red blood cells. The resulting red blood cells and plasma has a resulting hematocrit. Hematocrit is calculated or sensed in operative association with the third flow path and communicated to the flow controller for controlling the amount of plasma added to the third flow path and the resulting hematocrit.

Abstract: Method and apparatus for separating plasma from blood in a separation vessel and further separator the separated plasma into desired plasma proteins in a plasma separator fluidly connected to the separation vessel to receive the separated plasma.

Abstract: A connection of a patient's vascular system to an extracorporeal blood treatment machine is monitored to ensure the patient's safety during a procedure. The procedure may be hemodialysis, apheresis, plasmapheresis, a coronary by-pass operation, or other procedure. To ensure safe electrical connection, a contact and a return are connected via a conductive connection into the extracorporeal blood circuit. A current is then generated between the contact and the return and is monitored by a non-contact sensor near an access site of the patient. If the current or other quantity related to the current changes significantly, a signal is sent to the machine or a controller to notify a caregiver or a medical professional. The signal may also be sent to immediately stop a blood pump or other component of the machine.

Abstract: Apparatus for controlling an extra-corporeal blood treatment in a medical device, comprising a blood treatment device (7), an extra-corporeal blood transport line (4), a fluid transport line (3) for a treatment fluid for the blood, at least a sensor adapted to provide a measure (M) correlated to at least a treatment parameter of the extra-corporeal blood treatment and/or of the treatment device (7) in the medical device (1), at least one storage memory (29), and at least a control device (28), operatively connected at least with the storage memory (29) and with the sensor, and configured for receiving the measure (M) from the sensor, correlating the measure (M) with referential data (R) of the treatment device for the treatment parameter provided by the at least one storage memory (29), and correlating the measure (M) with patient historical data (H) for the treatment parameter for obtaining an information representative of the quality of the extra-corporeal blood treatment.

Abstract: Method for in-vivo plasmapheresis utilizing a plurality of elongated hollow microporous filter fibers periodically interrupt diffusion of blood plasma from a patient, and, for a selected time, directing backflush fluid into the fibers at a pressure and interval sufficient to cleanse the fiber pores, after which plasma diffusion is resumed. The backflush fluid, preferably a normal saline solution, may contain an anticoagulant such as heparin, citrate or NO donor in suitable concentration for systemic anti-coagulation or for treating the fiber for thromboresistance.

Abstract: A method and a device to increase the efficiency of dialysis for the removal from blood of substances that are more or less tightly bound to carriers such as albumin. According to the invention this is accomplished by a simultaneous significant increase of the flow rate of the dialysis fluid and of the area of the membrane that separates the blood from the dialysis fluid, compared to conventional dialysis.