Abstract: A blood purification device capable of performing an ideal blood purification treatment which accounts for blood recirculation is provided. That is, a blood purification device is furnished with a blood circuit containing an arterial blood circuit and a venous blood circuit for circulating blood outside the body, a dialyzer for purifying blood flowing in the blood circuit, hematocrit sensors for measuring the hematocrit value of blood circulating outside the body in the blood circuit, and a recirculation rate derivation means for obtaining a recirculation rate, and further provided with a true value derivation means for obtaining a patient's true hematocrit value based on the recirculation rate obtained by the recirculation rate derivation means.

Abstract: A continuous renal replacement therapy (CRRT) device adapted to be worn on a portion of the body of a patient. The CRRT device is worn by the patient and operates on rechargeable batteries for more than 5 hours. Dialysate is used to remove impurities from the blood. The dialysate is recycled and refreshed by a filter section. Less than one liter of dialysate is required to circulate through the wearable CRRT device.

Abstract: A hemofiltration system and method to treat an Inflammatory Mediator Related Disease in a mammal, including chronic and acute diseases, include a hemofilter and an adsorptive device. The hemofilter removes ultrafiltrate from a blood stream extracted from the mammal to create a filtered blood stream and an ultrafiltrate stream. The adsorptive device may include one or more adsorbent materials and may be used to adsorb inflammatory mediators from the ultrafiltrate stream received from the hemofilter to create a post adsorption ultrafiltrate stream. The post adsorption ultrafiltrate stream may be selectively combined with the filtered blood stream and together with the filtered blood stream may be returned to the mammal.

Abstract: A device and method for an extracorporeal blood treatment is described. The device comprising at least one exchanger equipped with at least one first inlet for the blood to be treated, a first fluid outlet and a second fluid outlet, an input line for blood to be treated connected to the first inlet of the exchanger, a blood output line (or venous line) connected to the first outlet of the exchanger, at least one treatment unit comprising at least one first fluid inlet and at least one first fluid outlet, the second outlet of the exchanger being in fluid communication with the first inlet of the treatment unit, where the first outlet from the treatment unit is in fluid communication with the input line and the second outlet of the treatment unit is in fluid communication with a first waste liquid discharge line.

Abstract: A hemodiafiltration/hemofiltration cartridge is preferably formed of a single cartridge providing multi-stage hemofiltration and hemodiafiltration defined by a first hemodiafiltration stage having first filtering elements and a second hemofiltration stage having second filtering elements. Both stages are contained in a single cartridge. The cartridge can be used in a mid-dilution scheme, a pre-dilution scheme or a post-dilution scheme.

Abstract: An automatic dialyzer for purifying blood brought into contact with a dialysate via a semi-impermeable membrane. The dialyzer includes at least a blood circulating system and a dialysate supply/discharge system, wherein the blood line of the blood circulating system is connected to an overflow line having a reversibly-rotatable blood pump, a blood chamber, and an open/close device for overflowing of liquid from the blood chamber to the outside of the blood line. Liquid supply means is provided to a first bypass line and/or a second bypass line for supplying liquid in both forward and reverse directions to enable regulation of the supply amount of the dialysate for water removing/liquid replenishing. The supply speed of the liquid supply device and the supply speed of the blood pump are regulatable in conjunction with each other. Also provided is a dialyzing method using the automatic dialyzer.

Abstract: A cartridge for treating medical or biological fluid includes a first cap having an inlet for the fluid, a container including a plurality of compartments and a second cap including an outlet for the fluid, wherein each compartment contains a plurality of particles, wherein the fluid is adapted to flow through the compartments and react with the plurality of particles.

Abstract: A first flow path is defined within a first panel that forms a part of an extracorporeal fluid circuit. A second flow path is defined within a second panel that also forms a part of the extracorporeal fluid circuit. The first and second panels are oriented in a fluid processing cartridge for mounting as an integrated unit on a fluid processing machine and for removal as an integrated unit from the fluid processing machine.

Abstract: Methods and devices for providing dialysis treatment are provided. The device includes a resin bed including zirconium phosphate, zirconium oxide, and urease.

Abstract: A method and apparatus for preventing and treating septicemia in patient blood is provided. The extracorporeal system includes an antimicrobial device to inactivate at least 99% of bloodborne microorganisms, a hemoconcentrator/filtration unit to remove approximately 50–75% of target molecules from the patient blood and a filter unit to remove target molecules from patient blood from the sieved plasma filtrate. Target molecules are produced by microorganisms, as well as by the patient's cells. These molecules include endotoxins from Gram negative bacteria, exotoxins from Gram negative and Gram positive bacteria, as well as RAP protein mediator from Staphylococcus aureus, and cell mediators such as tumor necrosis factor-alpha, and interleukin 1-beta, interleukin 6, complement proteins C3a and C5a, and bradykinin.

Abstract: The present invention provides an apparatus for separating components of a fluid having an outer housing containing a core wherein three separate fluid pathways are provided to allow continuous separation of biological fluids.

Abstract: A method and system for the extracorporeal treatment of blood to remove fluid from the fluid overloaded patient is disclosed that non-invasively measures an oxygen level in the venous blood. The oxygen blood level is used to detect when hypotension is about to occur in a patient. The oxygen level measurements are used as feedback signals. These feedback signals are applied to automatically control the rate of fluid extraction to achieve the desired clinical outcome and avoid precipitating a hypotensive crisis in the patient.

Abstract: A method and a device for determining the blood flow QF in a vascular access (F) during an extracorporeal blood treatment is described, where the blood enters the blood treatment unit (3) of the blood treatment machine through an arterial branch (19) of an extracorporeal circulation loop (2) which is in fluid connection with the vascular access at an arterial connection. The blood is returned through a venous branch (21) of the extracorporeal circulation, which is in fluid connection with the vascular access at a venous connection (13). The blood flow in the vascular access is determined by measuring the pressure part, pven, in the arterial and/or venous branch of the extracorporeal circulation when the vascular access is open and interrupted, while the extracorporeal blood flow QB is varied. Then the fistula flow QF is determined from the measured values for the arterial and/or venous pressure while the vascular access is open and interrupted.

Abstract: An extracorpeal blood circuit for removal of contrast from human blood using a filter and withdrawal filter pump and a by-pass pump. The withdrawal filter blood pump operates when a contrast bolus has been detected. Otherwise the bypass blood pump maintains physiological blood flow from the coronary sinus preventing the need for deflation and re-inflation of the balloon catheter. When contrast is detected blood the bypass blood pump is stopped to prevent contrast from leaking back into the patients circulatory system via the bypass pump and CS blood flow is maintained at its physiological blood flow resulting in the heart being oblivious to the transition by the prefilter blood pump.

Abstract: The present invention provides automated peritoneal dialysis systems, methods of operating the systems and devices for performing same. A typical therapy performed by the present invention begins by draining dialysis solution that is already in the patient's peritoneal cavity. The system pumps fresh dialysate from one of a plurality of supply bags, through an in-line heater to the patient's peritoneal cavity. After a dwell period, the spent dialysate in the cavity is pumped out of the patient to a drain or other disposal means. The system then pumps fresh dialysate from the supply bags to the patient and the procedure is repeated as defined in the therapy protocol. The system can pump a last bag of dialysate to the peritoneal cavity for an extended dwell, such as a daytime dwell.

Abstract: Apparatuses, devices, systems and methods for detecting access disconnection are provided. The present invention includes electrical contacts in fluid and electrical communication with a fluid passing between a patient and a medical system during therapy. In this regard, the present invention can use a direct-contact measurement to detect access disconnection, such as dislodgment of an access device from the patient through which fluid can flow during therapy including, for example, medication delivery, dialysis therapy and the like.

Abstract: Method and apparatus for the extracorporeal treatment of blood by utilizing a peripherally inserted dual lumen catheter assembly for the continuous removal and return of blood for renal replacement treatment, in particularly, treatment of congestive heart failure and fluid overload by ultrafiltration. A catheter is inserted in a peripheral vein and maneuvered upward through the vascular system to access the reservoir of blood in the large or great veins for continuous blood withdrawal and treatment. Air-tight connectors are incorporated in the catheter assembly to overcome the untoward effects of negative pressure in blood withdrawal.

Abstract: A device and method for increasing the safety of an extracorporeal blood treatment machine are based on monitoring transmembrane pressure. The transmembrane pressure measured by a measuring device during the treatment is compared with an upper limit transmembrane pressure L1 and a lower limit transmembrane pressure L2 which define a monitoring window. If the transmembrane pressure is outside this monitoring window, an alarm is triggered by an alarm device. The monitoring window is shifted as a function of the ultrafiltration rate. To determine the window limits, the transmembrane pressure is established after a change in the ultrafiltration rate is calculated. Thereafter, the window limits are determined on the basis of the expected transmembrane pressure.

Abstract: A dialysis machine comprises: means for calculating (60) a filtration factor (FF) as a function of the ultrafiltration rate (UFR) and of a plasma flow rate (Qp); first comparison means (65) for comparing the filtration factor (FF) with a limit value of admissibility; and signaling means (70) for generating a signal (A) indicating the result of the comparison.

Abstract: A dialysis apparatus for treating a patient with liver and/or kidney disease. In one embodiment a liver dialysis apparatus comprises an artificial liver. The artificial liver comprises a blood compartment, a vegetable protein compartment, and a clear dialysis compartment. In another embodiment the liver dialysis apparatus comprises cartridge made up of at least one layer of vegetable protein. In a further embodiment of the invention a dialysate regeneration device is provided which comprises at least one layer of vegetable protein. The vegetable protein is preferably a soy protein. The soy protein may be unmodified soy protein with urease enzyme activity, modified soy protein with or without urease activity, alone or in combination.

Abstract: The invention relates to a method for determining the volume of distribution of a blood component in the body of a living organism, especially the volume of distribution of urea, during an extracorporeal blood treatment. According to this method, the blood to be treated flows through the blood chamber (3) of a dialysis machine (1) in an extracorporeal circuit, said dialysis machine being divided into said blood chamber and a dialysing liquid chamber (4) by a semipermeable membrane (2). Dialysing liquid flows through the dialysing liquid chamber of the dialysis machine in a dialysing liquid channel.

Abstract: An adsorbent for removing hepatitis C virus which has the ability to adsorb HCV particles, particularly immune-complex HCV particles, from a patient's body blood safely and with high efficiency and high selectivity for enhancing the efficacy of interferon therapy, an HCV adsorption apparatus including said adsorbent, and a adsorbing method for removing HCV are provided. An adsorbent for removing hepatitis C virus which comprises a compound capable of adsorbing hepatitis C virus as immobilized on a water-insoluble carrier, an adsorption apparatus including said adsorbent, and an adsorbing method for removing HCV.

Abstract: A continuous renal replacement therapy device adapted to be worn on a portion of the body of a patient, including: a plurality of contoured dialyzers, which are connected in series and utilize dialysate to remove impurities from the blood of the patient; and a plurality of contoured sorbent device, which are connected in series and are for regenerating the spent dialysate.

Abstract: A circuit for extracorporeal treatment of a body fluid, the circuit including in serial fluidic communication an inlet for receiving the body fluid from a patient, a first pump, a first treatment device for processing the body fluid, a second pump, an outlet for returning processed body fluid to the patient; and a shunt. The shunt is upstream from the first pump and downstream from the second pump.

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: The invention relates to immunoadsorbers for use in sepsis therapy, in particular for removal of complement factors and lipopolysaccharides (LPS) and, if need be, further sepsis mediators such as TNF and interleukins from body fluids, methods for their production and their use.

Abstract: An apparatus and method for use in blood dialysis. The apparatus includes: two dialyzers each containing a semipermeable membrane that divides the dialyzer into a blood compartment and a dialysate compartment; a blood compartment connecting line connecting the blood compartments of the dialyzers together in series; blood connecting lines for connecting the blood compartments to the vascular system of a patient; a dialysate compartment connecting unit connecting the dialysate compartments of the dialyzers together in series; and dialysate connecting lines for connecting the dialysate compartments to a dialysis machine. The dialysate compartment connecting unit includes an adjustable flow varying device for controllably setting the rate of the flow of dialysate through the connecting unit.

Abstract: The invention relates to methods and compositions for delivering iron to an iron-deficient patient, more particularly, to methods whereby an iron complex comprising divalent or trivalent ionic iron complexed with one or more low molecular weight anions is administered to a patient by transfer from dialysate. A complex selected according to the invention is non-polymeric; soluble in an aqueous medium; chemically stable, thereby preventing the dissociation of iron ions from the anions under conditions according to the invention; and can be well absorbed into blood and the living body. Also provided are dialysate compositions including therein an iron complex selected according to the invention, and dialysate concentrates which may be diluted to yield an inventive dialysate composition.

Abstract: A method and a device for determining the blood flow QF in a vascular access (F) during an extracorporeal blood treatment is described, where the blood enters the blood treatment unit (3) of the blood treatment machine through an arterial branch (19) of an extracorporeal circulation loop (2) which is in fluid connection with the vascular access at an arterial connection. The blood is returned through a venous branch (21) of the extracorporeal circulation, which is in fluid connection with the vascular access at a venous connection (13). The blood flow in the vascular access is determined by measuring the pressure Part, Pven, in the arterial and/or venous branch of the extracorporeal circulation when the vascular access is open and interrupted, while the extracorporeal blood flow QB is varied. Then the fistula flow QF is determined from the measured values for the arterial and/or venous pressure while the vascular access is open and interrupted.

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: A dialyzer design that includes a potting material encasing a microfiber bundle in each end of a cylindrical body. The potting material is set by spinning the dialyzer in a centrifuge to force the potting material to the ends of the dialyzer interior chamber, where it sets with a non-planar surface. Dialysate fluid distribution rings define a space between the dialyzer interior chamber and dialyzer inlet and outlet ports, and laterally support the microfiber bundle against the dialysate fluid flow pressure. The dialysate fluid distribution ring circumferential edge substantially conforms to the non-planar potting material surface, to ensure that the lateral support to the microfiber bundle is constant, thereby lessening distortion, rupturing and obstruction of the microfibers.

Abstract: The present invention relates to a method and system for using a hemofilter to treat IMRD, hepatic failure, exogenous intoxication and other conditions associated with toxins in a patient's blood. One treatment includes the use of a very large pore hemofilter to remove target complex molecules and/or target molecules from a patient's blood and to infuse a replacement fluid into the patient's blood to maintain a prescribed albumin concentration in the patient's blood.

Abstract: A graphical user interface for a medical instruments for a Renal Replacement Therapy is disclosed that includes a pictogram representation of the fluid path of an extracorporeal blood circuit that represents fluid lines, pumps and sensors. To assist the user in responding to alarms and rectifying faults in the system the source of a potential trouble is animated. The location of a trouble spot is easily identified by flashing of the corresponding element of the pictogram, change of color or thickness of a corresponding line.

Abstract: This invention describes blood treating material having the capacity to selectively remove endotoxin and cytokine inducing substances from blood or plasma by extracorporeal adsorption for therapeutic septic shock treatment. The endotoxin adsorption ligands of the invention are oligopeptides synthesized from amino acids having a pk>7.2 such as arginine, lysine or histidine, using a polycondensation step such that the resultant oligopeptides exhibit a high degree of polydispersity. Also provided are methods and devices using an adsorbent having a polydisperse oligopeptide of the invention immobilized on a solid state support medium for removing endotoxin from the blood of human or animal subject.

Abstract: The present invention relates to a method and system for providing hemofiltration for reducing inflammatory mediator related diseases. In one form, a hemofiltration system for treating inflammatory mediator related diseases is disclosed. The system includes a hemofilter to receive blood from a specimen, the hemofilter removing selective inflammatory mediators from the blood and at least one therapeutic agent used in association with the hemofilter, the therapeutic agent to reduce adverse inflammatory mediator effects.

Abstract: A hemofiltration system for a mammal is provided with a hemofilter and an adsorbent device. The hemofilter removes ultrafiltrate from a blood stream extracted from the mammal to create a filtered blood stream and an ultrafiltrate stream. The adsorbent device has one or more adsorbent materials and is used to adsorb inflammatory mediators from the ultrafiltrate stream received from the hemofilter removing inflammatory mediators that cause inflammatory mediator related disease, sepsis, and SIRS/MODS/MOSF to create a post adsorption ultrafiltrate stream. The post adsorption ultrafiltrate stream is selectively combined with the filtered blood stream and together with the filtered blood stream is returned to the mammal.

Abstract: The present invention provides a dialysis machine that is readily moved by a patient, nurse or other operator. A display is provided on the front of the machine, which displays and controls various dialysis functions. The display is robust, mounted directly to the body and includes an open area that can be grasped by a person to move the entire machine. The combination display/handle enables the person to move the machine from the front of same and from odd angles with respect to the machine.

Abstract: A system and method are provided for determining the performance of a vessel, such as a hemodialysis access, which communicates blood between two locations of a patient. A conduit, such as an external dialysis circuit or an intravascular catheter, is provided in fluid communication with the vessel, and has a diversion point for diverting blood from the vessel into the conduit. The system further includes means for determining a flow rate of the diverted blood through the conduit. A first sensor in communication with the vessel generates at least one signal that is a function of a blood flow rate in the vessel downstream from the diversion point, wherein the downstream flow rate depends on the determined conduit flow rate and the performance of the vessel can be determined based on the signal. In addition, a processor can be provided in communication with the first sensor for determining a flow rate in the vessel upstream from the diversion point from the signal and the conduit flow rate.

Abstract: A method for measurement of mass and energy transfer parameters (clearance and dialysance) in hemodialysis. A sensor is provided in the dialysate flow path downstream of the dialyzer and means are provided to add concentrate upstream of the dialyzer. A pre-determined amount of a substance whose dialysance is to be measured is added upstream of the dialyzer. The amount of substance riot dialyzed in the dialyzer is measured downstream of the dialyzer by said sensor by integrating the concentration over time. Dialysance is calculated from the amount added upstream, the amount measured downstream and the dialysate flow. In case the substance is part of the dialysate the base concentration is subtracted during integration. The addition of the concentrate upstream of the dialyzer can be done manually or, alternatively by the mixing pump of the dialysis machine. Instead of an increase of the concentration with a concentrate dilution with water can be used as well.

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: A method and system for the extracorporeal treatment of blood to remove fluid from the fluid overloaded patient is disclosed that non-invasively measures osmotic pressure across a filter membrane of a blood filter. The filter is permeable to water and electrolytes, but not to blood protein. The osmotic pressure indicates the protein concentration in the blood. Osmotic pressure is used to detect when hypotension is about to occur in a patient, as a result of excessive blood volume reduction during treatment of the blood. Using the osmotic pressure measurement as a feedback signal, the rate of fluid extraction is automatically controlled to achieve the desired clinical outcome and avoid precipitating a hypotensive crisis in the patient.

Abstract: The present invention relates to novel methods and devices for treating severe bacterial infections, such as septicemia, using an extracorporeal adsorption container. The device has a solid support disposed and confined within the container and a binding means associated with the solid support that is specific for affixing an infecting bacterium that is causing the severe peripheral bacterial infection and/or bacterial toxins from the bacterium. By passing the infected blood through the container. at least a portion of the infecting bacterium and/or bacterial toxins are removed. The treated blood is returned to the patient.

Abstract: Method and apparatus for the extracorporeal treatment of blood by utilizing a peripherally inserted catheter assembly for the continuous removal of blood for renal replacement treatment, in particularly, treatment of congestive heart failure and fluid overload by ultrafiltration. A catheter is inserted in a peripheral vein and maneuvered upward through the vascular system to access the reservoir of blood in the large or great veins for continuous blood withdrawal and treatment. Air-tight connectors are incorporated in the catheter assembly to overcome the untoward effects of negative pressure in blood withdrawal.

Abstract: Method and device for determining in dialysis treatment the content of waste products in the outgoing dialysis liquid from the dialyzer. Measurement of the concentration of a certain substance or a combination of substances included in the waste products is effected spectrophotometrically directly on the outgoing dialysis liquid from the dialyzer. For that purpose there is provided after the dialyzer in or after the dialysing machine a measuring cell for spectrophotometric measurement. The measurement value obtained is multiplied by the flow of dialysis liquid for determining the content of said substance or said combination of substances in the outgoing dialysis liquid from the dialyzer.

Abstract: A biosensor capable of monitoring a number of different constituents of a dialysate solution used during dialysis therapy is provided. The biosensor of the present invention includes an integrated array of reactive elements and sensing elements that can be hydraulically coupled to the dialysate solution. In this regard, the biosensor can be utilized to provide on-line monitoring of total solutes removed from a patient during dialysis therapy, infection levels and/or other desirable parameters such that an overall assessment of dialysis therapy can be readily evaluated.

Abstract: A haemofiltration machine designed to work with a haemofilter comprises two compartments separated by a semipermeable membrane, one compartment having an inlet connected to a withdrawing tube for taking blood from the patient and an outlet connected to a blood return tube, the other having an outlet connected to a tube for removing used liquid.

Abstract: An intraoperative autotransfusion system and method of use. The system includes an autotransfusion device, a removable cassette, a cardiotomy reservoir, a container for holding washing fluid, and a reservoir for containing processed blood. The removable cassette includes a centrifugal cell, a peristaltic pump, and multiple clamps, each having fixed and sliding elements. The cassette has a housing and multiple ducts for connection to the cardiotomy reservoir.

Abstract: This invention provides a process for producing major histocompatibility antigen class II protein (hereinafter referred to as “MHC class II” for short) which occurs on the surfaces of antigen-presenting cells and the like, and MHC class II-bound materials in which MHC class II, &agr; and/or &bgr; subunit of MHC class II, or a part thereof is bound to a carrier such as beads, fibers and hollow fibers via covalent bond, as well as a module for removing superantigen using the same. This invention also provides a method for detecting or quantifying superantigens using MHC class II or a part thereof having an affinity to the superantigens, as well as an assay kit therefor.

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: An artificial kidney capable of cleaning blood, like a kidney of a healthy body, by any person even at home which is small in the size and simple in the structure and handling, without requiring any pharmaceutical solution. A metabolic end product separation chamber (9) is placed to the center of a cylindrical centrifugator (7) for circulating blood continuously and separating it into blood cell ingredients and plasma ingredients for conducting ultrafiltration of the separated plasmas and intaking water, serum electrolytes and unnecessary metabolic end products, in which a water re-absorbing module (11) capable of flowing the concentrated plasma ingredients and re-absorbing the water content and the serum electrolytes to obtain a cleaned plasma ingredient is placed, and the obtained cleaned blood ingredients are mixed with the blood cell ingredients separated by the centrifugator (7) to obtain cleaned blood.