Abstract: The invention relates to a calculation and control system for determining whether a patient intended to follow several sessions of hemodialysis treatment falls or not within one group among several groups of hypertension-affected patients, the system comprising: a) means for determining the value of at least one parameter representing the mass interdialytic evolution of the patient, for at least two sessions, b) means for determining the value of at least one parameter representing the plasmatic conductivity of the patient for at least two sessions, c) means for determining the value of a parameter representing the ionic mass transfer of the treatment for at least two sessions, d) programmed means for determining whether the patient falls or not within a group of hypertension-affected patients as a function of the interdialytic mass evolution of the patient, and/or of the plasmatic conductivity and/or of the ionic mass transfer.

Abstract: A system or method controls total fluid loss (TFL) in a patient undergoing hemofiltration therapy administered through an extracorporeal circuit by frequently calculating and storing a retrievable value representing TFL. At session start or restart, the value is read to determine whether TFL is out of tolerance, and if so, fluid balance is restored before administering a prescribed therapy. The TFL value is calculated during therapy by measuring fluid added to the circuit and fluid removed from the circuit, and the result is stored as an updated value. If TFL drifts out of tolerance fluid flow rates may be temporarily changed until a desired fluid balance is restored. The system may include a microprocessor based advanced controller receiving the fluid measurements as feedback for regulating substitution fluid and filtrate flow rates, and updating the TFL, value in non-volatile memory.

Abstract: The present invention relates to methods and systems for optimization of dilution of a viscous starting material to isolate and/or concentrate the product of interest from the starting source material such that the process minimizes the volume of diluent and the total volume of the waste stream generated during the process as well as maximizing the yield of desired product. The system employs cross-flow filtration modules with sub-channels that are equidistant to the inlet and outlet of said modules and such modules are characterized by optimal channel height, optimal transmembrane pressure, etc., which are selected in order to achieve the best combination of product quality and production yield.

Abstract: A cell sorting apparatus includes an extracorporeal circulation system 10 for sampling blood from a subject and circulating the blood outside a body; a cell measuring section 20 for supplying measurement light to cells contained in the blood to optically measure cell information on the physical quantity relating to the volume of the cell itself or a nucleus of the cell; and a cell separating section 30 for separating cells with reference to the cell information measured. The cell separating section 30 separates cells, based on the cell information measured by the cell measuring section 20 and a sorting condition set for sorting a specific type of cell such as a cancer cell, the cells satisfying the sorting condition, and returns the other cells into the body via the extracorporeal circulation system 10. Thus, a cell sorting apparatus can be realized which is capable of suitably sorting a target cell from the cells in blood.

Abstract: One or more waste balancing systems may be used in a fluid circulating system for medical use. The fluid circulating system may be part of a blood treatment system for a patient suffering renal failure. A waste balancing system may include a pressure element operable to maintain a constant fluid pressure created by the combined weight of waste removed from a patient and replacement fluid for providing to a patient. Multiple evaluation characteristics or control parameters may be evaluated or controlled for safety and accuracy. At least part of the waste balancing system may be incorporated into a disposable cartridge.

Abstract: An apparatus and a method for monitoring the supply of replacement fluid during an extracorporeal treatment of blood is disclosed. Detection of the supply of replacement fluid upstream or downstream of the dialyser or filter is based on a measurement of the optical or physical density of the blood or of a constituent of blood in the extracorporeal circulation. To detect pre- or post-dilution, the blood flow rate and/or the replacement rate and/or the flow rate of the fluid removed from the blood through the dialyser membrane is altered, and the density of the blood or of the constituent of blood is measured upstream and/or downstream of the dialyser. Additionally, an apparatus for treating blood with an apparatus for monitoring the supply of replacement fluid is disclosed.

Abstract: A reservoir for use with a blood collection system includes a housing, a pre-filter, and a spring mechanism. The housing defines a cavity and has an inlet for receiving fluid from a source. The pre-filter is located within the cavity, removes particulates contained within the fluid, and allows the fluid to pass through the pre-filter. The spring mechanism is connected to the pre-filter and allows the pre-filter to travel within the cavity as the pre-filter collects particulates.

Abstract: A size-selective hemocompatible porous polymeric adsorbent system is provided, the polymer system comprises at least one polymer with a plurality of pores, and the polymer has at least one transport pore with a diameter from about 250 Angstroms to about 2000 Angstroms, and the polymer has a transport pore volume greater than about 1.8% to about 78% of a capacity pore of volume of the polymer.

Abstract: Blood filtering device (1), comprising: * a filter body (3; 103), having an inlet port (4; 104) for blood to be filtered; * a delivery flexible hose (5; 105) of the blood to be filtered, apt to be connected to said inlet port (4; 104) and to further ducts linked to a circulatory system; * peristaltic pump means (10; 105, 109, 114, 115, 117, 118, 143, 144, 145), wherein a case (16; 116) forms at least one peristaltic pump rotor chamber (13; 114), apt to house inside a portion of said delivery flexible hose (5; 105) for obtaining a peristaltic effect, wherein said case (16; 116) defines means for maintaining said filter body (3; 103) in a working position.

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: The invention is directed to a method of removing a deleterious substance bound to a protein in blood of a patient by introducing a displacer substance into the blood under conditions in which the displacer substance replaces deleterious substance bound to the protein, thereby resulting in additional unbound deleterious substance in the blood, and removing unbound deleterious substance from the blood by extracorporeal renal replacement treatment.

Abstract: An integrated blood treatment module comprises a blood treatment device (1) having a housing (2) and a first end-cap (4) and a second end-cap (5) closing both ends of the housing (2). A pump hose (17) for a peristaltic pump has a first end (18) that is secured to the housing (2) and a second end (16) that is connected to a blood inlet port (15) of the first end-cap (4) so as to form a loop. A degassing device (30) is connected to the second end-cap (5). The degassing device (30), which, in use, is full of liquid, comprises a hydrophobic membrane through which bubbles and micro-bubbles escape the degassing device.

Abstract: Devices, systems, and methods are provided for controlling an inflammatory response in a subject. Extracorporeal devices, systems, and methods are provided that alter the functional structure of one or more inflammatory mediators in the peripheral blood of the subject. The device or system is useful in a method for treating an inflammatory disease or condition in the subject.

Abstract: An ultrafiltration device adapted to be worn on a portion of the body of a patient includes a blood inlet tube leading from a first blood vessel, a blood pump, an anticoagulant reservoir for infusing anticoagulants into the blood, a blood filter including a substrate through which the blood is circulated and filtered, a fluid bag for storing the excess fluid and a blood outlet tube leading to a second blood vessel.

Abstract: The invention relates to a filter device, preferably for hemodialysis, that consists of a cylindrical filter housing and a bundle of curled hollow fibers. The bundle is arranged in the filter housing. According to the invention, the curled hollow fibers are provided with an essentially sinusoidal texture and a wavelength that is defined by means of certain limits. The invention also relates to a curled hollow fiber and a method for filling a hollow fiber dialyser.

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: Devices, systems, and methods are provided for controlling an inflammatory response in a subject. Devices, systems, and methods are provided that alter the functional structure of one or more inflammatory mediators in the peripheral blood of the subject. The device or system is useful in a method for treating an inflammatory disease or condition in the subject.

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: Phosphate depletion, a physiological condition commonly seen in certain patient populations, including alcoholics, malnourished, acutely ill patients, patients receiving parenteral nutrition, patients being re-fed after prolonged fasting, and dialysis patients, requires intravenous supplementation when oral repletion is not feasible. This invention provides a method and pharmaceutical composition for therapeutic administration of pyrophosphate, instead of phosphate, for phosphate or pyrophosphate repletion. During hemodialysis or peritoneal dialysis significant removal of phosphate and pyrophosphate occurs. Pyrophosphate depletion predisposes patients to vascular calcification. This invention further provides a method and pharmaceutical composition for therapeutic administration of pyrophosphate for phosphate or pyrophosphate repletion by addition of pyrophosphate to hemodialysis or peritoneal dialysis solutions.

Abstract: In general, this disclosure relates to extracorporeal fluid circuits. In some aspects, an air-release device for allowing air to be released from a liquid in extracorporeal circuitry includes an elongate chamber having a bottom region and a top region and a fluid entry port and fluid exit port at or near the bottom region. The air release device also includes a vent structure at or near the top region of the elongate chamber that includes a porous material capable of swelling when moistened such that the vent structure can inhibit liquid from escaping the air-release device during use.

Abstract: A blood filtering device for the recuperation of blood from wound drained blood, in particular for an autologous blood transfusion system, has a first filter arranged upstream of a second filter. The first filter is adapted for removing emboli and/or large particulate matter from the blood and for allowing red blood cells to pass. The second filter is adapted for retaining red blood cells. An exit port is arranged downstream of the first filter and upstream of the second filter. The device is characterised in that the second filter has a pore size of more than about 0.5 ?m. A method of recuperating blood from wound drained blood is also disclosed.

Abstract: Solutions, dialysates, and methods for measuring solutes in blood and/or for treating blood. In one aspect of the invention, a method of performing dialysis includes placing a solution in communication with blood of a subject, where a concentration of at least one electrically conductive solute in the solution, prior to being placed in communication with the blood of the subject, is substantially equal to a concentration of the at least one electrically conductive solute in the blood of the subject.

Abstract: The present invention relates to a method for filtering blood to produce plasma or serum and to a blood filter for the production of plasma or serum from a blood sample. The invention further relates to a kit comprising a blood filter for the production of plasma or serum from a blood sample and a syringe.

Abstract: A cardiotomy and venous blood reservoir including a housing assembly, a downtube, and a bowl. The housing assembly forms a chamber. The downtube extends from an inlet port to a downstream end within the chamber. A diameter of the tube lumen increases to the downstream end. The bowl forms a floor surface shoulder, intermediate segment, and protrusion. The shoulder circumferentially surrounds, and is spatially above, the downstream end. The intermediate segment extends radially inwardly and downwardly from the shoulder to a bottom face. The protrusion extends radially inwardly and upwardly from the bottom face to a center that is aligned with the lumen and below the downstream end. The flared inner diameter of the lumen reduces fluid velocity as venous blood enters the reservoir. The bowl floor surface gently receives the incoming venous blood at the protrusion, and smoothly guides the blood flow.

Abstract: A method and apparatus for performing coronary perfusion and cardiac reoxygenation that enables accurate control of oxygen levels in blood used for the coronary circulation. Deoxygenated blood and oxygenated blood are collected and oxygen levels are measured by sensors. The deoxygenated and oxygenated blood is then mixed and the mixed blood is measured by another sensor. The sensors provide data used to provide real-time oxygen level measurement and adjustment for blood supplied for coronary circulation.

Abstract: The present invention relates to methods for the preparation of functionalized sulfated cellulose membranes. In particular, the present invention relates to the preparation of sulfated cellulose membranes under specific reaction conditions allowing to provide a sulfated cellulose membrane useful for pseudo-affinity purification. In another aspect, the present invention relates to the sulfated cellulose membrane itself as well as its use for isolation of proteinaceous compositions. Finally, the present invention provides a method for isolating whole virus, virus proteins or heparin binding molecules comprising the step of affinity purification using the sulfated cellulose membrane according to the present invention.

Abstract: Described are compositions and methods for treating liver disease, e.g., acute liver disease, using bone marrow-derived stem cells and bone marrow-derived stem cell conditioned media.

Abstract: A device, system and method for exchanging components between first and second fluids by direct contact in a microfluidic channel. The fluids flow as thin layers in the channel. One of the fluids is passed through a filter upon exiting the channel and is recycled through a secondary processor which changes the fluid's properties. The recycled fluid is reused for further exchange. The filter excludes blood cells from the recycled fluid and prevents or limits clogging of the filter. The secondary processor removes metabolic waste and water by diafiltration.

Abstract: A microfluidic fluid separator for separating target components of a fluid by filtration is described. Methods for separating target components of a fluid by filtration and methods for processing blood on a large scale with the microfluidic fluid separator are provided.

Abstract: The present disclosure describes novel standardized citrate replacement fluid solutions and a standardized dialysate solution for use with CRRT methods. The standardized citrate replacement fluid solutions and standardized dialysate solutions do not require modification based on the clinical status of the individual patients. The use of the standardized solutions described herein offers significant advantages over the prior art solutions used in CRRT. The present disclosure describes superior metabolic and electrolyte control and significantly increased dialyzer patency in: (a) 24 intensive care unit (ICU) patients with ARF using a 0.67% trisodium citrate replacement fluid solution, and (b) 32 ICU patients with ARF using a 0.5% trisodium citrate replacement fluid solution. Both groups were treated with Bicarbonate-25 dialysate and achieved effluent rates of 35 mL/kg/hr.

Abstract: The present invention provides a separating material producable by a) providing a solid substrate, having amino-functional groups coupled to the substrate surface, b) covalently coupling of the amino-functional groups with a thermally labile radical initiator, c) contacting the substrate surface with a solution of polymerizable monomers under conditions, where thermally initiated graft copolymerization of the monomers takes place, to form a structure of adjacent functional polymer chains on the surface of the substrate.

Abstract: A system and method for automatically adjusting a Continuous Cycling Peritoneal Dialysis (“CCPD”) therapy to minimize the potential for excess intra-peritoneal volume. The adjustments are made at the end of the drain, just prior to the next fill. The adjustments short the next fill, if necessary, to limit the intra-peritoneal volume, add a cycle, if necessary, to use all of the available dialysis solution and will average the remaining dwell time to maximize the therapeutic benefit of the therapy in the allotted time. In another embodiment, a tidal therapy using trended patient UF data is provided.

Abstract: The present disclosure describes devices useful for microscale fluid purification, separation, and synthesis devices. Generally, such devices comprise a fluid membrane that separates two or more fluids flowing through plural microchannels operatively associated with the membrane. The fluids can both be liquids, gases, or a liquid and a gas, such as may be used for gas absorption into a liquid. Often, the membrane is a semipermeable membrane, such as might be used with a filtration device, such as a dialyzer. Devices of the present invention can be combined with other microscale devices to make systems. For example, the devices may be coupled with one or more microchemical microfactories, one or more micromixers, one or more microheaters; etc. Examples of devices made according to the present invention included an oxygenator, a dialzyer, microheat exchangers, etc. Particular materials had to be developed for use with certain embodiments of the device disclosed herein.

Abstract: An extracorporeal blood system includes: an extracorporeal blood machine including an extracorporeal blood circuit; an access device enabling the extracorporeal blood circuit to be connected to a patient; first and second tube connecting members for connecting respectively to first and second tubes of the extracorporeal circuit; first and second electrodes held, at least in part, by the first and second tube connecting members so as to contact blood flowing through the extracorporeal blood circuit, the first and second electrodes enabling an electrical signal to be injected into the extracorporeal blood circuit; first and second contact members contacting the first and second electrodes respectively; and electronics coupled operably to the first and second contact members for applying the electrical signal, the signal used to monitor the access device.

Abstract: One object of the present invention is to provide polymers suitable for use as medical materials. The present invention provides a polymer useful as a medical material having the general formula -(A)1-(B)m—(C)n—??(I) in which A is derived from an alkoxyalkyl (alkyl)acrylate monomer; B is derived from a monomer containing a primary, secondary, tertiary or quaternary amine group; C is derived from a non-ionic monomer; and 1+m+n=100,0<1, m, n<100.

Abstract: An ultrafiltration device adapted to be worn on a portion of the body of a patient includes a blood inlet tube leading from a first blood vessel, a blood pump, an anticoagulant reservoir for infusing anticoagulants into the blood, a blood filter including a substrate through which the blood is circulated and filtered, a fluid bag for storing the excess fluid and a blood outlet tube leading to a second blood vessel.

Abstract: The invention concerns a composite support comprising a base support for the treatment of a biological fluid, in which: “the base support is essentially-constituted by a first polymer carrying anionic or anionizable groups;” at least a part of the surface of the base support is coated with a second polymer ionically bonded to the first polymer, the second polymer carrying the cationic or cationizable groups which are capable of forming an ionic bond with the anionic or anionizable groups of the first polymer; in which the second polymer is in the colloidal form and in mixture with a polyacid during application to the support, allowing the composite membrane to adsorb at least one entity containing anionic or anionizable groups by bonding with cationic or cationizable groups of the second polymer.

Abstract: The present invention includes a comprehensive replacement fluid system and method for the delivery of regional citrate anticoagulation (RCA) to extracorporeal blood circuits, wherein the system may include an online clearance monitor (OCM) and a circuit effluent online sensor system (OSS) for the continuous determination of patient plasma content of ultrafilterable solutes.

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 renal treatment fluid priming method includes priming an extracorporeal circuit connected to a patient with a physiologically compatible fluid, the extracorporeal circuit including an arterial line, a venous line and blood compartment of a blood filter; and pumping from a renal treatment fluid line in communication with the blood filter (i) pulling blood from the patient through the arterial line to flush the physiologically compatible fluid through the arterial line and the blood filter compartment into the renal treatment fluid line and (ii) pulling blood from the patient through the venous line to flush the physiologically compatible fluid through the venous line and the blood filter compartment into the renal treatment fluid line, such that a greater volume of blood is pulled from the patient via (i) and (ii) than a volume of the extracorporeal circuit.

Abstract: A patient wearable, continuously operating extracorporeal pump apparatus which accesses the patient's arterial venous pressure differential by applying external pressure to a subcutaneous graft that has been cannualized to modulate blood flow through an extracorporeal circuit and to drive the pump for delivering a medicament, such as an anticoagulant, to the site of an intravenous cannula to prevent clogging thereof and also to move a dialysate through a circuit, including a dialyzer and a dialysate rejuvenating cartridge, whereby kidney failure can be treated without recourse to prior art hemodialysis machines found in most treatment facilities. With slight modification, the present invention can be used to remove excess fluids from CHF patients, to remove toxins from the blood in those suffering from liver failure and to facilitate administration of insulin to diabetics and/or glucose to those having hypoglycemia.

Abstract: A machine (1) for extracorporeal blood treatment comprises a device (2) for ultrafiltration of a liquid through a semi-permeable membrane (3) of a blood treatment device (4), a first sensor (11) for ultrafiltration rate through the membrane, a second group of sensors (13) for measuring a trans-membrane pressure, and a programmed controller (14) for calculating a maximum ultrafiltration rate as a function of the transmembrane pressure. The machine is suitable for kidney failure treatments, such as hemofiltration and hemodiafiltration. In a relatively short time the machine enables a large quantity of corporeal blood to be removed from the patient.

Abstract: An extracorporeal filtration and detoxification system and method generally comprise separating ultrafiltrate from cellular components of blood, treating the ultrafiltrate independently of the cellular components in a recirculation circuit, recombining treated ultrafiltrate and the cellular components, and returning whole blood to the patient. A recirculation circuit generally comprises an active cartridge including active cells operative to effectuate a selected treatment; in some embodiments, the active cells are the C3A cell line.

Abstract: A device, system and method for exchanging components between first and second fluids by direct contact in a microfluidic channel. The fluids flow as thin layers in the channel. One of the fluids is passed through a filter upon exiting the channel and is recycled through a secondary processor which changes the fluid's properties. The recycled fluid is reused for further exchange. The filter excludes blood cells from the recycled fluid and prevents or limits clogging of the filter. The secondary processor removes metabolic waste and water by diafiltration.

Abstract: A device, system and method for exchanging components between first and second fluids by direct contact in a microfluidic channel. The fluids flow as thin layers in the channel. One of the fluids is passed through a filter upon exiting the channel and is recycled through a secondary processor which changes the fluid's properties. The recycled fluid is reused for further exchange. The filter excludes blood cells from the recycled fluid and prevents or limits clogging of the filter. The secondary processor removes metabolic waste and water by diafiltration.

Abstract: A device, system and method for exchanging components between first and second fluids by direct contact in a microfluidic channel. The fluids flow as thin layers in the channel. One of the fluids is passed through a filter upon exiting the channel and is recycled through a secondary processor which changes the fluid's properties. The recycled fluid is reused for further exchange. The filter excludes blood cells from the recycled fluid and prevents or limits clogging of the filter. The secondary processor removes metabolic waste and water by diafiltration.

Abstract: This invention provides a method for controlling a fluid separation system, preferably a blood apheresis system having a leukocyte reduction chamber. The method utilizes at least a two-level alarm system. A first-level alarm condition is triggered in response to a pressure drop in the system to less than or equal to a specified system pressure and pauses fluid flow in at least a portion of the system. A second-level alarm condition is triggered in response to a specified number of said pressure drops within a specified period and reduces the flow rate of the fluid in the system. The alarm conditions may also trigger a visible and/or audible alarm. These alarm levels permit flow through the leukocyte reduction chamber to continue when the pressure drop is caused by a non-serious, self-resolving or easily-correctable condition such as misalignment of system components.

Abstract: The present invention is directed to devices, systems and methods 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 invention is useful in a variety of situations where a sample fluid is to be purified via a diffusion mechanism against an extractor fluid. Moreover, the invention 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.