Abstract: An extracorporeal therapy machine removes blood from a patient in order to treat the blood and then return the blood to the patient. If the removal needle or the return needle is dislodged and blood is not returned, the patient may suffer a great blood loss. A new technique for detecting dislodgement uses the normal, initial values of a plurality of parameters of the patient and the therapy machine to set criteria or limits for an alarm, and then adjusts those criteria based on the later values of those parameters as they change during one therapy or over several therapies experienced by the patient.

Abstract: The present invention relates to dialysis devices comprising peristaltic pumps of linear build with piezoelectric actuators.

Abstract: The invention provides container systems, kits and methods for peritoneal dialysis (PD) solutions. Such a system, for example, includes a first compartment that contains a PD osmotic agent and a second compartment that contains a PD buffer agent. The compartments maintain their respective contents separately from one another for purposes of transport, storage and/or sterilization. However, the compartments are fluidly couplable, so that their respective contents can be combined with one another, e.g., following sterilization of the agents and prior to their introduction into the patient's abdomen.

Abstract: A method of removing toxins from blood from a patient in need of such toxin removal includes: providing a countercurrent dialysis filter (20) having a blood compartment and a dialysate compartment separated from the blood compartment by a semi-permeable membrane; conveying blood from the patient through the blood compartment of a countercurrent filter (20) an back to the patient; and drawing dialysate from a reservoir (32) through the dialysate compartment of the countercurrent filter (20). At least one of the blood or dialysate experiences pulsatile flow. The steps are carried out such that blood toxins are drawn from the blood compartment through the semi-permeable membrane into the dialysate compartment.

Abstract: A blood purification apparatus that can make the specific peak to be imparted to the blood more distinct, and therefore can detect blood recirculation reliably and precisely, is presented. It contains a blood circuit route, a blood pump, a dialyzer, dialysate introduction and discharge lines, a duplex pump, a pressurizing pump, a blood concentration means, and detection means that detect the specific peak imparted by the blood concentration means. The blood concentration means is configured to have an atmosphere release line, the tip of which is open to the atmosphere, that extends from between the pressurizing pump and the duplex pump in the dialysate discharge line, and to have an electromagnetic valve that can open or close the atmosphere release line. The electromagnetic valve opens the atmosphere release line to impart the specific peak by rapidly concentrating the blood flowing in the dialyzer for a short period of time.

Abstract: Microfluidic bioreactor devices may feature intercommunicating microchannels defined in two polymer layers separated by a membrane. A geometric parameter associated with the microchannels in one layer may vary along a length of those channels.

Abstract: The present invention provides an apparatus for separating components of a fluid having an outer housing containing a core and other components wherein three separate fluid pathways are provided to allow continuous separation of biological fluids; this apparatus is particularly useful for the administration of extracorporeal photopheresis in that it enhances the collection of the desired blood components, the return of the treated blood, and the speed with which the therapy is administered.

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 switch valve for use in an extracorporeal blood flow circuit comprises a valve housing having a chamber, four openings communicating with the chamber, and a valve member located in the valve chamber. A first opening is to be connected to a patient via an arterial cannula, a second opening is to be connected to a patient via an venous cannula, a third opening is to be connected to a first inlet/outlet of a blood treatment device, and a fourth opening is to be connected to a second inlet/outlet of a blood treatment device. The valve member is movable within the valve housing to fluidly connect the first opening to either the third or the fourth opening and to fluidly connect the second opening to either the third or the fourth opening. The width of the valve member is smaller than a peripheral dimension of the openings.

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: 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 system for priming an extracorporeal blood circuit is described. The system includes a fluid circuit with an air venting mechanism, a reversible pump, arterial and venous lines, a prime waste bag and a switchable coupler selectively connecting the arterial and venous lines to the waste bag or alternatively interconnecting the arterial and venous lines. A priming fluid is connected to the circuit and circulated in the circuit under different configurations of the arterial and venous line connections.

Abstract: The present invention relates to a method and system for using a very large pore 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: Disclosed herein are methods, systems and devices to monitor vascular volume status during renal replacement therapy utilizing at least one oximetry/photoplethysmography sensor. The methods, systems and devices provide an alternative to conventional vascular volume monitoring methods during renal replacement therapy while enabling reliable, non-invasive, and automatic monitoring of vascular volume to avert patient hypotension. The methods, systems and devices may be employed in the context of both inpatient and outpatient dialysis facilities and may also be incorporated into conventional hemodialysis and hemofiltration techniques and equipment.

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.

Abstract: The present invention relates to filtration devices and related methods of use. In particular, the present invention relates to implantable filtration devices used, for example, for filtering impurities from a body fluid of a subject.

Abstract: A continuous renal replacement therapy (CRRT) device is provided that weighs between 2 and 10 pounds. The CRRT device can be portable, mobile or completely worn on the person of the patient. Blood and dialysate are each pumped in a pulsed or pulsatile manner through a dialyzer such that a significant portion of the peak pulse of the blood flow coincides with a significant portion of a low pulse portion of the dialysate flow. An differential pressure between a dialysate inlet of the dialyzer and the blood inlet of the dialyzer periodically changes from a high differential pressure of between 70 and 120 mmHg for a first time period and a low differential pressure of between ?10 and 10 mmHg for a second time period. The frequency of the high and low differential pressure cycle is between about 0.5 and 4 Hz.

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: A dual channel pulsatile pump for use with a completely wearable renal replacement device is provided.

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: An improved method for separating whole blood into components and collecting a desired blood component. The method allows a desired blood component to be subjected to centrifugal forces within a separator for prolonged periods of time, yielding a cleaner cut and higher yield of the desired blood component. Whole blood is drawn from a source and pumped into a separator, the undesired blood components are removed from the separator at rates so as to build up the desired blood component in the separator. The desired blood component is only removed after a predetermined amount of the desired blood component has built up in the separator. It is preferred that the desired blood component be buffy coat and that the method be used to perform photopheresis treatments. In another aspect, the invention is a method of performing a full photopheresis treatment to treat diseases in a reduced time, preferably less than about 70 minutes, and more preferably less than about 45 minutes.

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.

Abstract: An automatic priming method in which an arterial-side chamber is maintained in a normal position during priming, as in a case of dialysis treatment, and in which forward and backward rotations of a blood pump are employed, and a speed of rotation, in particular, backward rotation, is adjusted to be low, so that air or the like is reliably prevented from entering a dialyzer. The priming method for use in a blood purification circuit in which priming is conducted by supplying physiological saline into a circulation circuit formed by connecting an arterial blood circuit with a venous blood circuit includes filling the venous blood circuit with a priming solution (physiological saline), discharging the priming solution for cleaning the arterial blood circuit, conducting a treatment in a direction opposite to the overflow step, which may be followed by a forward direction re-circulation step, and re-circulating in a forward direction.

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: An external functional means comprises at least one housing body, at least one chamber integrated into the housing body for receiving medical fluids, at least one passage integrated into the housing body for receiving and/or conducting a medical fluid, and at least one valve means completely or partly integrated into the housing body for controlling or regulating a fluid flowing through the external functional means. The invention further specifies a blood treatment apparatus and methods which may be carried out by means of the external functional means of the invention and by means of the blood treatment apparatus, respectively.

Abstract: A medical fluid circuit comprises a fluid transport unit connected to a source of a medical fluid for infusion into an extracorporeal blood circuit. A support element for the transport line exhibits three engaging projections predisposed for mounting the unit to an external apparatus. A first and a second projection each comprise a first and a second tubular extension (38), while a third projection (37) is distant from an imaginary straight zone which unites the tubular extensions. An ultrafilter (28) for ultrafiltration of the medical fluid is situated in a space comprised between the third projection and the imaginary straight zone. The unit, which is for providing a replacement fluid to a hemo(dia)filtration apparatus, can be easily mounted on the apparatus.

Abstract: The present invention relates to a device for extracorporeal removal of harmful agents from blood or blood components, comprising full length heparin immobilized on a solid substrate by covalent end point attachment. The present invention also relates to a method for extracorporeal removal of a harmful agent from mammalian blood or blood components. The present invention further relates to a process for covalent end point attachment of full length heparin to a solid substrate.

Abstract: A renal therapy blood cleaning system includes: a blood filtering device in communication with an extracorporeal circuit; a first pump configured to pump fluid to the blood filtering device; a second pump configured to pump fluid from the blood filtering device; a balance chamber in fluid communication with first and second lines, the first and second lines in fluid communication with the first and second pumps, respectively, the balance chamber configured to exchange like volumes of fresh and spent fluid; a plurality of valves; and a control scheme programmed to operate the plurality of valves to enable spent fluid taken from the balancing chamber through one of the first and second lines to be recirculated to the balance chamber through the other of the first and second lines to compensate for a volume of fresh fluid delivered to the blood filtering device.

Abstract: An apparatus for hemo(dia)filtration comprises an extracorporeal blood circuit and a supply line of a replacement fluid to the extracorporeal blood circuit. The supply line has a bifurcation which divides a main branch (24) into a pre-dilution branch (25) and a post-dilution branch (26). A pump tube tract (29) is predisposed in the supply line for coupling with a circuit pump of the replacement fluid. An expansion chamber is predisposed in the extracorporeal blood circuit and is fluidly connected to the pre-dilution branch. The invention provides a disposable fluid circuit usable for performing a hemodiafiltration treatment with pre-dilution and post-dilution which is couplable simply, rapidly, economically and reliably to a machine for monitoring the treatment.

Abstract: Provided is a hemodialyzer for preventing beforehand any medical accident such as air inclusion or blood loss during a medical treatment by detecting even a minute connection failure, if any.

Abstract: A peristaltic roller pump includes a rotor carrying a pumping roller on one end and an occluding roller on the other end. Occluding roller has a number of protrusions designed to occlude the tubing section that is located under that roller as it moves over it in order to prevent any back flow through that section of the tube. Occluding roller is designed to not cause any pumping of fluid through the section of the tubing under that roller. Such design is useful in a single-needle dialysis system in which during a first phase of pumping blood is moved in one direction from the patient towards the dialysis unit and during the second phase of operation blood is returned to the patient in the opposite direction.

Abstract: A method and device for blood treatments that use fluids such as dialysate and replacement fluid for renal replacement therapy. In an embodiment, fluid is passed either by pump or passively by gravity feed, through a microporous sterilization filter from a fluid source to a replacement fluid container. The latter forms a batch that may be used during treatment. The advantage of forming the batch before treatment is that the rate of filtering needn't match the rate of consumption during treatment. As a result, the sterilization filter can have a small capacity. In another embodiment, a filter is placed immediately prior to the point at which the sterile fluid is consumed by the treatment process. The latter may be used in combination with the former embodiment as a last-chance guarantee of sterility and/or that the fluid is free of air bubbles. It may also be used as the primary means of sterile-filtration.

Abstract: The present invention relates to a method for checking and/or monitoring the correct operation of an adding device of a medical apparatus, wherein the medical apparatus includes an extracorporeal circuit with which the adding device is connected such that an agent can be introduced into the extracorporeal circuit by means of the adding device, the pressure loss in the extracorporeal circuit being measured and evaluated for checking and/or monitoring the correct operation of the adding device. In accordance with the invention, the adding device for this purpose generates an oscillating pressure course.

Abstract: A biological fluid device (703) comprises a pressure sensor (702), which is arranged on the device. The pressure sensor comprises a compressible container, the compression of which is indicative of the pressure, and is capable of wireless communication.

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 hemodialysis apparatus includes a blood processing machine, a blood circuit through which blood led from a patient flows, a blood pump attached to the blood circuit to pump blood, a dialysate circuit, a clamp disposed downstream of the blood pump for the blood circuit to block the blood circuit, a blood pressure sensor for detecting the pressure of a part of the blood circuit between the blood pump and the blocker, and a control unit connected with the blood pump and the blood pressure sensor. The control unit is configured to determine, based on the pressure detected by the blood circuit pressure detector, whether or not the blood circuit has encountered abnormal conditions while the blood circuit blocked by the clamp is filled with liquid by the blood pump (steps SA2, SA3, and SA5).

Abstract: A treatment assembly is positioned along an AV-fistula and couples therapeutic energy to an adjacent area due to a material response to an applied energy field from a remotely located energy source. The treatment assembly may be delivered into the fistula through a hemodialysis needle, or may be secured to the fistula graft itself and implanted therewith in a patient. A cover provides a shield between an anastomosis area and blood flow. Another AV-fistula includes a valved reservoir that receives a fluid agent from a hemodialysis needle while moving the needle into or from the fistula; the agent leaks from the reservoir into the fistula lumen. Another valved fistula is adjustable between an open condition and closed conditions during and between hemodialysis treatments, respectively. Another AV-fistula has a bladder reservoir coupled to a second refillable fluid reservoir and is adapted to locally deliver a therapeutic agent into the fistula lumen.

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 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: Systems and methods for improving medical fluid delivery systems, such as hemofiltration (“HF”) and hemodiafiltration (“HDF”) are provided. In first embodiments, systems and methods for selectively performing pre- and postdilution HF and HDF clearance modes is provided. In other embodiments, systems and methods for providing prime bolus and rinseback fluid volumes before, during and/or after HF and HDF therapies are provided. In further embodiments, improved systems and methods for removing ultrafiltrate from the patient are provided. Still further, improved filtration configurations and methods are provided.

Abstract: A method for aligning a disposable cassette within a dialysis machine includes actuating a pump head toward the disposable cassette and to contact a pumping portion of the disposable cassette and shift the disposable cassette if need be into proper operational alignment and locking the disposable cassette in place.

Abstract: The present invention relates to a method and a device for monitoring a blood treatment unit, subdivided by a semipermeable membrane into a blood chamber and a dialysis liquid chamber, of an extra-corporeal blood treatment device, which comprises an extra-corporeal blood circuit having an arterial branch leading to the blood chamber of the blood treatment unit, a venous branch, which extends away from the blood chamber, and a dialysis fluid system, in which the dialysis liquid chamber is arranged.

Abstract: The invention relates to support element (4) comprising a main body (6) having a front wall (25) and a peripheral wall (32) projecting away from the front wall. The front wall and the peripheral wall define a housing compartment (33) designed to receive a fluid distribution circuitry cooperating with a treatment unit for defining an integrated blood treatment module.

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 blood purification apparatus in which the pressure in a circuit is measured by directly measuring the strain of an air trap by a strain sensor without providing a pressure measuring section in the circuit.

Abstract: Blood treatment apparatus comprise an enclosure having one or more blood treatment modules, typically, hollow fiber bundles, therein. A blood flow inlet distribution network divides an inlet blood flow into a series of successive individual blood flow stages in order to increase uniformity of the distribution of the blood flow into the hollow fiber bundles. The inlet blood flow may be divided in two, three, four, or more stages, providing a large number of end stage flow channels to feed blood into the hollow fiber bundle.

Abstract: A hemodialysis patient data acquisition and management system resides on a host computer which receives information from one or more non-invasive, optical blood monitors associated with a hemodialysis system. When a patient is undergoing hemodialysis treatment, a sensor assembly monitors the patient's blood flowing through the hemodialysis system and a controller for the blood monitor generates data which includes at least an identification code for the patient undergoing the treatment on the respective system, and non-invasively determined blood data taken at the onset of the scheduled treatment, such as initial Hgb, HCT, and SAT values. A host computer communicates with the one or more optical blood monitors, preferably via a wireless network, and the patient's session commencement data is downloaded to the host computer.

Abstract: A device is provided for transferring mass and/or exchanging energy between two media, particularly between blood and a gas/gas mixture. The device includes a chamber (2), through which the first medium flows and inside which at least one mass-permeable and/or energy-permeable hollow fiber (5), preferably a plurality of mass-permeable and/or energy-permeable hollow fibers (5), is/ are arranged. The second medium can flow through the at least one hollow fiber (5), while the first medium can flow therearound. At least one pumping element (5), which allows the first medium to be displaced from the chamber (2) and/or to be sucked into the chamber (2), is disposed in the chamber (2) of the device.

Abstract: An example embodiment of the invention provides a system and method for detecting a liquid leak that includes a sensor with a passive resonant circuit having a resonant frequency, an interrogation unit to transmit a radio frequency (RF) wave corresponding to the resonant circuit's resonant frequency, and a receiver to measure the resonant circuit's response. A determination unit is configured to determine the presence of liquid based on the measured response. In the absence of liquid, the resonant circuit radiates a signal corresponding to its resonant frequency; however, in the presence of liquid, the resonant circuit's electrical characteristics change such that the resonant circuit does not resonate at its resonant frequency. The resonant circuit may include inductive and capacitive elements formed on a substrate using electrically conductive materials. Thus, the system may quickly, safely and accurately detect potentially life-threatening blood leaks that may occur during, for example, hemodialysis.

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.