Abstract: An in-vivo plasmapheresis and/or in-vivo ultrafiltration membrane comprises a plurality of elongated hollow fibers each fiber having an interior lumen extending along the fiber length, the fiber wall having a plurality of zones between the inner and outer wall surfaces, each of the zones having a mass density different than the mass density of an adjacent zone. The fiber wall is characterized by having a lower mass density zone at the inner wall surface and a higher mass density zone at the outer wall surface.

Abstract: The invention relates to a method for the effective treatment of diseases associated with a deterioration of the macrocirculation, microcirculation and organ perfusion to achieve an improvement of the local environment and the metabolic situation and to aim at the improvement of organ function or the stabilization of organ function with imminent functional deterioration, which comprises the treatment of blood of patients by extracorporeal plasmapheresis techniques.

Abstract: A portable hand-held blood sampling device having a self-filling capability includes a blood separation filter. The filter has a plurality of pores sized to permit passage of selected blood constituents such as blood plasma through the device. The device has a separated blood conduit that extends beyond the outlet of the device and is shaped for easy penetration into a self-sealing septum of a blood analyzer. An annular shield extends from the device outlet beyond the conduit to prevent inadvertent contact of the conduit by a user.

Abstract: Methods and apparatus particularly involving the separation of blood into blood components and the collection of such components are disclosed. In one aspect, an extracorporeal method for the collection of plasma and red blood cells is provided, wherein the collection of plasma and red blood cells may occur simultaneously or subsequently utilizing the same dual stage blood processing vessel. The flow of blood to the blood processing vessel and return of uncollected blood components may be provided via a single needle, wherein blood is removed from and returned to a donor/patient during alternating blood removal and blood return submodes. Platelet separation and collection options are also described. In either case, prior to red blood cell collection, a set-up phase may be carried out to set a predetermined hematocrit and AC ratio. Replacement fluid delivery may optionally also be provided either substantially continuously during any collection phase(s) and/or in a bolus mode.

Abstract: The platelet gel manufacturer includes a platelet gel applicator, a controllable platelet receptacle, a controllable coagulant receptacle, and a controllable platelet gel receptacle. The controllable platelet receptacle is fluidly coupled to the closed corporeal system, the controllable coagulant receptacle is fluidly coupled to the controllable platelet gel receptacle, and the controllable platelet gel receptacle is fluidly coupled to the platelet gel applicator. The controllable platelet receptacle is operable to receive the platelet rich plasma obtained from the patient by the closed corporeal system, and controllably deliver the platelet rich plasma to the controllable platelet gel receptacle. The controllable coagulant receptacle is operable to store a coagulant used to produce platelet gel, and controllably deliver the coagulant to the controllable platelet gel receptacle.

Abstract: Systems and methods separate blood cells from whole blood and pump the separated blood cells through an in-line leukofilter to a blood cell storage container. The leukofilter has a filtration medium enclosed within a flexile housing. The systems and methods employ a fixture to restrain expansion of the flexible filter housing during operation of the pump. The fixture has a bracket to enable its releasable attachment to the blood processing device employed to carry out the separation process.

Abstract: Automated systems and methods for withdrawing a selected compound from blood are disclosed. The systems and methods utilize a disposable fluid circuit mounted on a re-usable hardware component or module. The system withdraws blood from a donor or patient, separates the blood into two or more components and further combines the separated component with a solvent so as to remove a compound from the blood component.

Abstract: A method for carrying out therapeutic apheresis comprises separating plasma from whole blood in-vivo and removing selected disease-related components from the separated plasma. Apparatus for carrying out therapeutic apheresis includes a filter device for being implanted in a blood vessel for carrying out in-vivo plasma separation having one or more elongated hollow tubes and a plurality of elongated hollow microporous fibers capable of separating plasma from whole blood at pressure and blood flow within a patient's vein, a multiple lumen catheter secured to the proximal end of the filter device having one or more lumens in fluid communication with the interior of said one or more hollow tubes and a plasma return lumen, and therapeutic apheresis apparatus for removing and/or separating selected disease-related components from the separated plasma and means for directing plasma between said catheter and the selective component removal apparatus.

Abstract: Devices and methods of delivering therapeutic agents to tissue are provided, which provide reduced outflow of therapeutic agents from an injection site. The methods include delivering one or more clot-promoting substances, such as platelets, fibrin and/or thrombin, to the injection site to entrap the therapeutic agent in the injection site. Devices include devices that are suitable for use in the provided methods.

Abstract: A method for rapid purification of a blood component from blood is described in which the blood plasma is first separated from the cellular blood elements by any conventional means, such as centrifugation. An affinity cartridge is then activated with a molecule, such as an amino acid, which binds with a blood component such as plasminogen. The separated blood plasma is then passed through the affinity cartridge such that the blood component is retained by the affinity cartridge. Thereafter, the blood component is eluted from the affinity cartridge by passing a buffer solution containing a releasing agent through the affinity cartridge. This releasing agent disengages the blood component from the affinity cartridge. The releasing agent is then separated from the eluted solution by passing the eluted solution through a device, such as an ion exchange, gel filter, or size exclusion device. The isolated plasminogen solution is then concentrated by a factor of from 2 to 10. The separated blood component, e.g.

Abstract: Apparatus and 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, 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 in suitable concentration for systemic anti-coagulation or for treating the fiber for thromboresistance.

Abstract: Apparatus and 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, backflush fluid into the fibers at a pressure and interval sufficient to cleanse the fiber pores, after which plasma diffusion is resumed.

Abstract: A method and apparatus for producing blood component products. In one embodiment, a plurality of a predetermined type of blood component is harvested from a source of whole blood. At least two on-line yield determination techniques are utilized to determine the yield for the harvested blood components. One is a predetermined yield prediction technique and the second is a predetermined yield monitoring technique, each of which are individually calibrated in relation to a predetermined off-line yield determination technique. The predetermined yield prediction and monitoring techniques each provide the yield for the harvested blood components and each is then utilized to provide a determined yield. Consequently, when the harvested blood components are packaged the determined yield my be associated therewith, thereby providing a blood component product.

Abstract: A method for treating systemic inflammatory response syndrome (SIRS) by contacting the bodily fluid of a patient with renal tubule cells outside of the kidney.

Abstract: A system compact enough to be located entirely beside the donor's chair, and able to process the blood while the donor is still resting in the chair after having donated the blood. The separated blood components (plasma and red blood cells) may be stored in their individual optimum environments immediately after the whole blood is drawn, and the blood does not need to be transported back to a separation laboratory for processing. The system includes a needle (72) (or other cannula-like device) for insertion into a vein of the donor and drawing whole blood therethrough, a rotor (2a) for holding the blood after it is drawn, and a motor (50) for spinning the rotor so as to cause the blood to separate into components, for example, plasma and red blood cells.

Abstract: A system for automatically collecting and separating whole blood into its components is described. The system includes a console, which contains all motors, pumps, sensors, valves and control circuitry, and a unique disposable set that includes a cassette supporting a centrifuge with an improved design, pump interfaces with an improved design, component and solution bags, and tubing. Various processes are implemented using a specific disposable set for each process which allows automatic identification of the process to be performed the console.

Abstract: A system for collecting red blood cells (RBCs) and other blood components that reduces the need for human intervention. A disposable set is provided having a port, an RBC container, a centrifuge rotor having a variable total volume, and a filter, along with tubing connecting the port, the container, the rotor and the filter. A control unit is also provided and includes a spinner in which the rotor may be held, a flow-control arrangement for controlling flow among the various components of the disposable set, and an electronic controller. The whole blood is directed by the flow-control arrangement from the port through the tubing to the rotor. The rotor includes an elastic diaphragm, and the control unit's flow-control arrangement includes a pump or other device for applying a positive and negative pressure to the rotor's elastic diaphragm. The spinner rotates the rotor so as to separate the whole blood into plasma and RBCs.

Abstract: Segmental edema is treated by inserting a plasma extraction filter device in a major vein of a body segment or servicing the body segment containing the edemic tissues, and inserting a return catheter in a major artery of the body segment affected or feeding the body segment from which plasma is extracted. Blood plasma and plasma proteins extracted from the edemic body segment through the plasma extraction filter fluids are directed to an ultrafiltration apparatus where plasma water is separated from the plasma proteins. Plasma proteins are returned to the body segment from which the plasma was extracted via the return catheter in the major artery of the subject body segment.

Abstract: An extracorporeal blood processing system is disclosed which includes a variety of novel components and which may be operated in accordance with a variety of novel methodologies. For instance, the system includes a graphical operator interface which directs the operator through various aspects of the apheresis procedure. Moreover, the system also includes a variety of features relating to loading a blood processing vessel into a blood processing channel and removing the same after completion of the procedure. Furthermore, the system also includes a variety of features relating to utilizing a blood priming of at least portions of the apheresis system in preparation for the procedure. In addition, the system includes a variety of features enhancing the performance of the apheresis system, including the interrelationship between the blood processing vessel and the blood processing vessel and the utilization of high packing factors for the procedure.

Abstract: The present invention is directed to a method of treating cells, tissues or organs using in vivo plasma separation by implanting a plasma separation filter device within a blood vessel of a patient, or allogenic, or xenogenic donor, continuously separating blood plasma from whole blood in vivo, directing the plasma from the plasma separation filter device to a bioreactor, and exposing the plasma to cells, tissue or an organ within the bioreactor utilizing immune separation membranes where necessary.

Abstract: Segmental edema is treated by inserting a plasma extraction filter device in a major vein of a body segment or servicing the body segment containing the edemic tissues, and inserting a return catheter in a major artery of the body segment affected or feeding the body segment from which plasma is extracted. Blood plasma and plasma proteins extracted from the edemic body segment through the plasma extraction filter fluids are directed to an ultrafiltration apparatus where plasma water is separated from the plasma proteins. Plasma proteins are returned to the body segment from which the plasma was extracted via the return catheter in the major artery of the subject body segment.

Abstract: A filter device for being implanted in a blood vessel for carrying out in-vivo plasma separation comprises one or more elongated hollow tubes and a plurality of elongated hollow microporous fibers, each fiber having a first and second end secured to one or more of the elongated hollow tubes with the interior lumen of each of the fibers communicating with the interior of the one or more of the hollow tubes, and wherein the fiber wall has a higher mass density zone adjacent to the outer wall surface and a lower mass density zone adjacent to the inner wall surface.

Abstract: A blood processing system comprises a blood separation chamber constructed and arranged for rotation about an axis separate blood into a plasma layer and an adjoining region comprising different first and second cellular blood species arranged in layers according to density. A collection line including a pump removes the plasma layer from the blood separation chamber. The pump operates to control flow through the collection line in response to pump control signals. A sensor assembly in the collection line detects concentration of first and second cellular blood species in the collection line. A controller coupled to the sensor assembly operates to generate the pump control signals according to a selected blood collection protocol. The controller operates, when a first blood collection protocol is selected, to generate a pump control signal when the sensor assembly detects changes in concentration of the first cellular blood species in the collection line.

Abstract: A multi-stage cell segregation from the plasma by staged separation and rinsing processes is performed while the plasma is diverted to the dialyzer and de-watering steps are completed without the cells being present. Cleaning the plasma of the urea and other life threatening toxins and pathogens permits a faster and more thorough cleaning of the plasma and cells which in turn reduces the therapy time.

Abstract: To provide a blood processing system easy to operate and excellent in safety factor, the blood processing system includes a plasma separating unit for separating a plasma from a blood; a plasma purifying unit for purifying the separated plasma to which the plasma is introduced into the plasma purifying unit through a plasma introducing fluid circuit by means of a plasma feed pump, and a plasma return fluid circuit for returning the plasma, which has been purified by the plasma purifying unit, back to the plasma separating unit. A plasma inlet pressure gauge measures a pressure of the plasma at the plasma intake port of the plasma feed pump. A bypass fluid circuit extending between the plasma introducing fluid circuit and the plasma return fluid circuit for bypassing the plasma feed pump and the plasma purifying unit has a valve disposed therein for opening the bypass circuit.

Abstract: An extracorporeal blood processing system is disclosed which includes a variety of novel components and which may be operated in accordance with a variety of novel methodologies. For instance, the system includes a graphical operator interface which directs the operator through various aspects of the apheresis procedure. Moreover, the system also includes a variety of features relating to loading a blood processing vessel into a blood processing channel and removing the same after completion of the procedure. Furthermore, the system also includes a variety of features relating to utilizing a blood priming of at least portions of the apheresis system in preparation for the procedure. In addition, the system includes a variety of features enhancing the performance of the apheresis system, including the interrelationship between the blood processing vessel and the blood processing vessel and the utilization of high packing factors for the procedure.

Abstract: This invention describes a method for pumping or delivering fluids utilizing a flexible vessel subject to controlled pressures within another pressure vessel. The pressure vessel can be sourced with positive and/or negative (e.g., vacuum) pressure.

Abstract: The present invention is directed to a method of treating cells, tissues or organs using in vivo plasma separation by implanting a plasma separation filter device within a blood vessel of a patient, or allogenic, or xenogenic donor, continuously separating blood plasma from whole blood in vivo, directing the plasma from the plasma separation filter device to a bioreactor, and exposing the plasma to cells, tissue or an organ within the bioreactor utilizing immune separation membranes where necessary.

Abstract: The invention relates to a filter arrangement for the separation of blood into plasma and cellular components, comprising at least one filter element with an inlet and an outlet chamber (24) in a closed housing (9), separated by a fine pore membrane. The inlet chamber is connected to an inlet line (13) for donor blood and an outlet line (14) for cellular components and the outlet chamber (24) is connected to an outlet line (15) for plasma. The arrangement further comprises a device for the production of a back-pressure in the filter element, whereby the fine pore membrane is in the form of a U-shaped bundle (1) of n=650 hollow fibres (21) of the type Micro PES-TF 10 from Akzo Faser AG, the ends of which are fixed in an air-tight and germ-tight manner to an aperture plate (5) which seals the open end region (8) of the housing (9), which is open at just one end, in an air-tight and germ-tight manner.

Abstract: Segmental edema is treated by inserting a plasma extraction filter device in a major vein of a body segment or servicing the body segment containing the edemic tissues, and inserting a return catheter in a major artery of the body segment affected or feeding the body segment from which plasma is extracted. Blood plasma and plasma proteins extracted from the edemic body segment through the plasma extraction filter fluids are directed to an ultrafiltration apparatus where plasma water is separated from the plasma proteins. Plasma proteins are returned to the body segment from which the plasma was extracted via the return catheter in the major artery of the subject body segment.

Abstract: Plasma fluid removal is needed in a variety of clinical conditions including congestive heart failure and moderate renal insufficiency. In order to avoid the problems inherent in extracorporeal ultrafiltration methods, the present invention removes fluid using an intravascular or intracorporeal dual-lumen catheter. Plasma fluid is driven across a semipermeable membrane, as in an in vivo vascular catheter. Suboptimal intracatheter flow, luminal collapse, erratic high transmembrane flow with nonhomogenous caking and clotting of the external catheter surface are all avoided by inducing pressure gradients across the wall by means of osmotic forces instead of negative pressures induced by hydraulic pumps. Osmotically induced fluid flow would tend to keep the lumena slightly distended and thereby simplify the fluid delivery systems.

Abstract: A platelet collecting apparatus 1 comprises a centrifugal separator 20 possessing a rotatable rotor 142; a first line 21 for allowing the flow of the blood entering the centrifugal separator 20; a second line 22 for allowing the flow of the blood emanating from the centrifugal separator, a plasma collecting bag 25 connected to the first line 21 and the second line 22 so as to collect the plasma emanating from the centrifugal separator 20 and return the collected plasma to the centrifugal separator 20, a platelet collecting bag 26 connected to the second line 22 so as to collect the platelets emanating from the centrifugal separator 20, a blood delivering pump 11 disposed in the first line 21, and a controller 13 for controlling the operation of the rotor of the centrifugal separator 20 and the operation of the blood delivering pump 11.

Abstract: An apparatus and methods for enhanced plasmapheresis comprising a filter membrane under an orbital motion or movement that has optimal local shear forces and maximum plasma flow output. The separation apparatus comprises a first plate, a second plate and a hollow interior therebetween, wherein the second plate is detachably coupled to a non-rotational drive structure that controls the second plate in an orbital motion in reference to a center axis of the first plate for enhanced blood separation.

Abstract: Apparatus and 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, backflush fluid into the fibers at a pressure and interval sufficient to cleanse the fiber pores, after which plasma diffusion is resumed.

Abstract: Blood processing systems and methods convey blood drawn from a donor through a blood processing circuit to separate the blood into at least one targeted blood component for collection. The systems and methods derive an estimated effect of the procedure upon the donor. The estimated effect can be expressed in terms of a net blood fluid volume loss, or as a hematocrit of the donor after completion of the desired blood collection procedure. The systems and methods present the estimated effect to an operator for viewing, reading, or offloading.

Abstract: A system for collecting and processing blood from a donor (70), wherein the system may be compact enough to be located entirely beside the donor's chair, and be able to process the blood while the donor is still resting in the chair after having donated the blood. Thus, the separated blood components (plasma and red blood cells) may be stored in their individual optimum environments immediately after the whole blood is drawn, and the blood does not need to be transported back to a separation laboratory for processing. The system includes a needle (72) (or other cannula-like device) for insertion into a vein of the donor and drawing whole blood therethrough, a variable-volume rotor (2a) for holding the blood after it is drawn, and a motor (50) for spinning the rotor so as to cause the blood to separate into components, for example, plasma and red blood cells. The system also provides for a container for collecting a separated component.

Abstract: A blood processing device is self-contained within a case, which sized to enable hand transport. Self-contained in the case is a blood separation device, which, for example, can comprise a centrifuge. A controller is also self-contained in the case. The controller includes a control program for carrying out one or more blood processing procedures. A fluid processing system employs a centralized cassette containing preformed, fluid pressure actuated pump stations, preformed fluid flow paths, and preformed, fluid pressure actuated valves in the fluid flow paths. A fluid pressure actuator in the case holds the cassette and selectively applies fluid pressure force to the valves and pump stations in response to the control program. The control program thereby operates the cassette to convey blood to and from the blood separation device through the fluid processing system.

Abstract: Blood separation systems and methods draw whole blood from a blood donor selected from a population of blood donors. The whole blood of the selected blood donor has a known hematocrit value that varies within the population of blood donors according to morphology of the selected blood donor. The systems and methods operate a pump in the inlet line to convey a volume of whole blood from the donor at a commanded flow rate for processing into plasma constituent and concentrated red blood cells. The systems and methods set the commanded flow rate to vary the volume of whole blood conveyed over time as a function of the known hematocrit value of the selected donor. The systems and methods obtain, after processing the whole blood volume, a targeted volume of concentrated red blood cells, which is substantially constant for the population of blood donors despite variances in known hematocrit values among the donors.

Abstract: Systems and methods separate platelets from a selected donor. The systems and methods convey anticoagulated blood containing plasma and platelets from the selected donor into the separation device for separating into a plasma yield and a platelet yield. The systems and methods estimate, at least in part while separation occurs, a count of platelets (PltCirc) available for collection from the selected donor by measuring the selected donor's platelet precount (Pltpre), estimating a dilution factor caused by addition of anticoagulant (Dilution), and estimating a depletion factor (Depletion) caused by removal of available platelets during blood processing. In estimating Depletion, the systems and methods take into account a splenic mobilization function (Spleen), which is derived from a population of donors and not specific to the selected donor, where Spleen comprises a function of PltPRE.

Abstract: A separating device for extracting cholesterol from plasma uses a spinner to disperse plasma into an extracting solvent in the form of fine droplets to improve separation efficiency, thereby making it suitable for delipidating blood plasma. Blood plasma is delipidated by providing the plasma to the spinner and dispersing the plasma into the extracting solvent in fine droplets. A de-emulsification step removes residual solvent from the plasma. Blood is removed from an animal and the blood plasma is delipidated. Delipidated plasma is de-emulsified and combined with the animal blood, which is then reintroduced into the animal.