Abstract: This disclosure relates to vial spiking assemblies and related methods. In certain aspects, the vial spiking assemblies include a vial adapter having a base, a spike extending from a central region of the base, and a sidewall extending from the base and surrounding the spike. The base and the sidewalls partially, define a cavity that is configured to receive at least a portion of the vial. The assemblies also include a spike cover that is removably attached to the spike and that includes a material configured to indicate when the material is contacted with liquid.

Abstract: According to one embodiment, a dialysis device is made available that can be implanted at least partially into the body of a patient and comprises a blood chamber, through which the patient's blood can flow, a dialysis chamber for receiving a dialysate, and a hydraulic pump device for compressing the two chambers alternately by means of a hydraulic fluid, wherein both chambers are each equipped with two valves for controlling the inflow and outflow of blood and dialysate, respectively, and wherein both chambers are connected to each other in an area designed as a membrane.

Abstract: A pump cassette is disclosed. The pump cassette includes a housing having at least, one fluid inlet line and at least one fluid outlet line. The cassette also includes at least one reciprocating pressure displacement membrane pump within the housing. The pressure pump pumps a fluid from the fluid inlet line to the fluid outlet line. A hollow spike is also included on the housing as well as at least one metering pump The metering pump is fluidly connected to the hollow spike on the housing and to a metering pump fluid line. The metering pump fluid line is fluidly connected to the fluid outlet line.

Abstract: The present invention involves, in some embodiments, systems and methods for performing an integrity test on a medical grade cassette that is configured to be used on a medical fluid handling system, wherein the cassette may be disposable and may comprise a membrane therein. The test may be configured to determine an error condition, such as detection of membrane leakage above a threshold value, and may in certain cases be implemented by a medical computer system. In certain cases the integrity test is a dry integrity test and in certain cases, the test is configured to determine a leakage rate of fluid through the membrane.

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 invention concerns a circuit comprising a bag (111) comprising two flexible films (145, 146) and routing network connectors, and a press (110) comprising a first shell (114) and a second shell (113) clamping the bag to form pipes (104) between the films, the first shell comprising a pinch valve (120) which comprises an actuator (121) comprising a movable member (124) and in register with the moveable member an elastically compressible pad (131) which, when the valve is in an open position, has a resting configuration in which a second face (33) of the pad is concave and locally delimits a shaping channel (118), and, when the valve is in a closed position, has a pinching configuration in which the second face (133) is convex, with the pipe and the pad sandwiched between a shaping channel (116) and the moveable member.

Abstract: A dialysis system includes a dialysis machine having a pump actuator, a valve actuator and a sorbent device, and a disposable cassette including (i) a housing having a dialyzer inlet port, a dialyzer outlet port, a pump portion configured to operate with the pump actuator, a valve portion configured to operate with the valve actuator, a venous port, and an arterial port, (ii) at least one dialyzer in fluid communication with the housing, the at least one dialyzer including a dialysate inlet, and a dialysate outlet; (iii) an arterial line for connecting to a patient, the arterial line connected to and extending externally from the arterial port of the housing; (iv) a venous line for connecting to a patient, the venous line connected to and extending externally from the venous port of the housing; and (v) first and second dialysate fluid connections in fluid communication with the sorbent device.

Abstract: A concentrate container for preparing a medical fluid, preferably for preparing a dialysis solution, is provided, the concentrate container including at least two concentrate compartments, wherein at least one of the concentrate compartments has a medical fluid outlet, and at least one of the concentrate compartments has a diluent inlet. Further, systems for preparing a medical fluid and a method for preparing a medical fluid are described.

Abstract: A method for providing a negative pressure wherein a pump is cycled on and off to achieve a target negative pressure, which is set slightly lower than the therapeutic negative pressure. A device determines the actual pressure by averaging samples which may occur at a different rate than the pump cycle.

Abstract: A liquid collection bag is used as a part of an extracorporeal circuit and is connected via a tube to a storage container containing a priming solution. The collection container collects the priming solution from the storage container by a pressure differential between the pressure inside the collection container and the pressure inside the storage container. The liquid collection container is a flexible bag body having a partition part dividing the inside of the bag body into a first space and a second space. In addition, a communication part communicates the first space with the second space.

Abstract: The invention further relates to an apparatus and method for monitoring a peristaltic hose pump, in particular a peristaltic hose pump of an extracorporeal blood treatment device. The power consumed by the pump and/or the pressure in the tubing segment upstream or downstream of the pump is/are measured during operation of the pump and test signals I1(t), I2(t) which are associated with the individual displacement members are determined. The power or pressure signals associated with the individual displacement members significantly differ from each other during abnormal operation of the hose pump, but no significant differences can be recognized during normal operation of the pump.

Abstract: A dialysis system includes a fresh dialysis fluid membrane pump; a spent dialysis fluid membrane pump; a first balance chamber having a fresh dialysis fluid compartment connected fluidly to the fresh dialysis fluid membrane pump and a spent dialysis fluid compartment connected fluidly to the spent dialysis fluid membrane pump; a second balance chamber having a fresh dialysis fluid compartment connected fluidly to the fresh dialysis fluid membrane pump and a spent dialysis fluid compartment connected fluidly to the spent dialysis fluid membrane pump; and a dialysis fluid cassette, wherein at least one of the fresh dialysis fluid membrane pump, the spent dialysis fluid membrane pump, the first balance chamber and the second balance chamber includes a fluid receiving portion provided in the dialysis fluid cassette.

Abstract: A method of pneumatically operating a dialysis system includes (i) pumping air in a first valve state from a pneumatic pump to operate a component of the dialysis system, and (ii) recirculating air in a second valve state by pumping air from an outlet of the pneumatic pump to an inlet of the pneumatic pump to minimize at least one of a noise pitch or noise amplitude when switching from the second valve state to the first valve state.

Abstract: A method is provided for regulating fluid pump pressures by detecting an elevation differential between a fluid flow control device and the distal end of a fluid line in communication with the fluid flow control device. A fluid flow control device, for instance a peritoneal dialysis device, is at a first height, a distal end of a fluid line is at a second height, and a valved outlet, when open, affords communication between the fluid flow control device and the distal end of the fluid line. The elevation differential is correlatable with a pressure measurable during a calibration procedure provided as a part of the methodology.

Abstract: An access disconnection system includes a venous line, an arterial line, a first electrode coupled to (i) the arterial line, (ii) a patient, or (iii) a cardiac catheter assembly; and a second electrode coupled to (i) the venous line, or (ii) the cardiac catheter assembly. The access disconnection system further includes electronic circuitry communicating electrically with the first second electrode to sense an electrical heartbeat signal generated by the patient. The electronic circuitry is configured to send a disconnection output indicative of a change in the electrical signal sufficient to expect that an access disconnection of the venous line has occurred.

Abstract: A cardiopulmonary bypass system utilizing membrane-based reciprocating positive displacement blood pumps (“pod pumps”). In one aspect, the pod pumps are constructed to provide reduced shear forces on the blood being pumped. In another aspect blood flow through the pod pumps can be controlled by a controller using information from pressure sensors in the control chamber of the pod pumps. In another aspect, the pod pumps are included on a disposable unit that can be received and held by a receptacle means on a base unit, the base unit also providing pressurized control fluid to the pod pumps on the disposable unit through the receptacle means.

Abstract: Embodiments of the present invention relate generally to heat-exchanger systems that can be used to heat or cool a fluid such as blood. Pod pumps that provide low shear and low turbulence may be used in such systems, particularly for systems that pump blood. A certain heat-exchanger system used to heat blood or other fluids may be used to provide whole-body hyperthermic treatments or regional hyperthermic chemotherapy treatments. A disposable unit may be used to separate the fluid path from the fluid control systems. The disposable unit typically includes a heat-exchanger component that is received by a corresponding heat exchanger in a base unit. Fluid pumped through the heat-exchanger component is heated by the heat exchanger.

Abstract: A dialysis fluid pressure manifold system includes a plurality of pump and valve chambers controlling a flow of dialysis fluid; a header including a plurality of pneumatic passageways, each passageway in pneumatic communication with one of the pump or valve chambers; a plurality of electrically actuated pneumatic valves; and a plate defining a plurality of pneumatic apertures, each pneumatic aperture in pneumatic communication with one of the plurality of electrically actuated pneumatic valves, the plate providing the apertures each with an o-ring seal for airtight connection with the pneumatic passageways of the header.

Abstract: In a single needle extracorporeal blood treatment apparatus, an ultrafiltration pump (10) performs a pure ultrafiltration of ultrafiltrate from an hemofilter (4). The blood may be continuously circulated through the hemofilter using a first pump (5), which alternates an higher flow rate during the arterial phase and a lower flow rate during the venous phase, and a second pump (6) which is maintained at a flow rate intermediate between said higher and lower flow rate. The apparatus may be used for treatment of Congestive Heart Failure.

Abstract: A method includes initiating a blood fluid removal session of a patient; monitoring an indicator of tissue fluid volume of the patient, or a portion thereof, during the blood fluid removal session; monitoring an indicator of blood fluid volume of the patient during the blood fluid removal session; determining whether a ratio of the indicator of tissue fluid volume to indicator of blood fluid volume is outside of a predetermined range; and altering the rate of fluid removal during the blood fluid removal session if the ratio is determined to be outside of the predetermined range. A blood fluid removal system may be configured to carry out the method.

Abstract: A blood purification apparatus has a dialyzer (1), an arterial blood circuit (2) with a blood pump 4, a venous blood circuit 3, a dialysate introduction line L1, a dialysate discharge line L2, a substitution line L3, and a substitution pump 9 that supplies the dialysate flowing in the substitution line L3 to the arterial blood circuit 2. A control device (11) estimates or measures the concentration of blood in a dilution channel section A. The control device (11) controls the volume of dialysate supplied by the substitution pump 9 on the basis of the estimated or measured blood concentration.

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: A system and method for removing gas bubbles from blood during circulatory assist procedures. An active filter apparatus forces the bubbles to the center of the system where they are removed from the blood before the blood exits the filter.

Abstract: A process fluid pump can include a pump chamber, an inlet valve, and an outlet valve. Diaphragm regions can define at least a portion of each of the pump chamber, the inlet valve, and the outlet valve. The diaphragm regions can each have an actuation region with a surface that is convexly shaped when the formed actuation region is in a natural unstressed first state, and each formed actuation region can be actuated by a motive fluid to transition to a second state in which the surface is non-convexly shaped.

Abstract: Patients suffering from acute renal failure must be diagnosed and treated quickly so that a physician can confidently prescribe either peritoneal dialysis or hemodialysis. In one way of quickly treating the patients, software is used to calculate a suitable peritoneal dialysis prescription without regard to how short or how long a dialysis cycle is used, and without regard to a total dialysate fluid volume for a therapy. For patients with suitable peritoneal membrane transport properties, the software program suggests that, at least over a short period of time, unexpectedly high ultrafiltrate volumes and high clearances may be achieved.

Abstract: A dialysis system includes: a blood filter; a dialysate pump connected to a dialysate portion of the blood filter; a blood pump connected to a blood portion of the blood filter, the blood pump including a diaphragm that is moved in cycles to pump the blood, the cycles having a flow period and a no-flow period; a patient access device in fluid communication with the blood portion of the blood filter, the no-flow period having a first characteristic of a property when the patient access device is lodged in a patient and a second characteristic of the property when the patient access device is dislodged from the patient; and a logic implementer configured to determine that the patient access device has been dislodged from the patient when the second characteristic of the parameter is detected.

Abstract: A dialysis machine that includes a valve member having a deformable area configured to deform outwardly away when pressurized fluid is introduced into the valve member. The valve member is configured so that, when a dialysis fluid cassette is disposed in a cassette compartment of the dialysis machine and pressurized fluid is introduced into the valve member, the deformable area obstructs a fluid channel of the dialysis fluid cassette to control dialysis fluid flow therethrough.

Abstract: A method includes monitoring an indicator of fluid volume of a patient via a sensor device, and setting an initial fluid volume removal prescription for a blood fluid removal session based on the monitored indicator of fluid volume. The method may further include transmitting data regarding the indicator of fluid volume from the implantable sensor device to fluid removal device. In some embodiments, the fluid removal device sets or calculated the initial fluid volume removal prescription based on the data received from the implantable sensor. The indicator of fluid volume may be an indicator of tissue fluid volume or an indicator of blood fluid volume.

Abstract: A coupler includes a conductive polymer material that is so constructed and arranged to join tubing, wherein the conductive polymer material includes a conductive polymer component selected from the group consisting of polyaniline, polypyrrole, polythiophenes, polyethylenedioxythiophene, poly(p-phenylene vinylene) and mixtures thereof.

Abstract: The present invention relates to a method for removing blood from an extracorporeal blood circuit and/or a functional device, each connectable or connected with a blood treatment apparatus for the purpose of blood treatment of a patient. The blood treatment apparatus of the method comprises or is connected with at least one extracorporeal blood circuit with a line having interior portions, the extracorporeal blood circuit comprising at least one arterial line section and at least one venous line section, wherein a first section of the arterial line section is configured to be connected with a second section of the venous line section, and further comprises at least one blood pump for conveying blood within the line interior portions. The method includes the step of operating the blood pump in a second conveying direction which is opposite to a first customary conveying direction. It further relates to corresponding apparatuses.

Abstract: The present invention concerns a multipart fluid system for use in CRRT, wherein the multipart fluid system comprises an anticoagulation fluid and at least one fluid from the group consisting of a dialysis fluid and an infusion fluid. According to the invention the anticoagulation fluid comprises at least 8 mM citrate, and the dialysis fluid and/or infusion fluid comprises 2-8 mM citrate and 1-5 mM total calcium. The present invention further concerns a system for regional citrate anticoagulation in an extracorporeal blood circuit.

Abstract: A device for the filtration of a complex fluid composition such as blood, includes a base (12) with a bottom (18), a top (14) with a bottom (30), and a membrane (16) that is arranged between the base and the top so as to define a low chamber C1 and a high chamber C2, with an input tap (26) of the complex composition that is to be filtered emptying into the low chamber C1, an output tap (28) of the retentate with elements for adjusting the flow rate emptying into this same low chamber C1, and an output tap (36, 36-1) of the high chamber C2, whereby this output tap (36, 36-1) of the permeate is subjected to negative pressure.

Abstract: A blood oxygenator includes an integral pneumatic pump disposed substantially within a housing thereof, an inlet blood flow redirector, and an outflow blood collector. An atrium provided at an inlet of the oxygenator promotes even delivery of blood to the oxygenator. In use, the oxygenator provides an even dispersion of blood therethrough, establishing even perfusion and reducing areas of stagnant blood flow.

Abstract: A method for operating a dialysis cassette including a flexible membrane that covers a pump chamber includes applying a vacuum about a piston head and sucking the flexible membrane of the dialysis cassette onto the piston head; mechanically retracting the piston head along with the vacuum applied membrane away from the dialysis cassette to draw fluid into the pump chamber; mechanically extending the piston head and the flexible membrane into the pump chamber to expel fluid from the pump chamber through a flow path; and directly sensing a pressure of the fluid flowing through the flow path at a location of the dialysis cassette adjacent to the pump chamber.

Abstract: A hemodialysis system includes an on-line dialysate generator; a dialysate pump actuator configured to pump dialysate generated by the generator to a dialyzer; a conductivity sensor located adjacent to a temperature sensor upstream of the dialyzer; a blood pump actuator; an air detector; and a disposable cassette configured to carry dialysate pumped by the dialysate pump actuator, the disposable cassette including a conductivity sensor portion and a temperature sensor portion located to operate with the conductivity sensor and the temperature sensor, respectively, the disposable cassette further configured to carry blood pumped by the blood pump actuator and to provide an air detection portion located to operate with the air detector.

Abstract: A catheter assembly for use in accessing a vasculature of a patient during renal replacement or other therapies is disclosed. In one embodiment, the catheter assembly includes a catheter body that defines first and second lumens. The catheter body defines a distal tip region that includes a venous lateral opening that is in fluid communication with the first lumen and an arterial lateral opening that is in fluid communication with the second lumen.

Abstract: An improved intravascular blood pump and related methods involving the broad inventive concept of equipping the intravascular blood pump with guiding features such that the intravascular blood pump can be selectively positioned at a predetermined location within the circulatory system of a patient.

Abstract: Apparatus and methods for providing extracorporeal blood circulation and oxygenation control include seven-stage de-airing of blood to provide automated cardiopulmonary replacement to sustain patient life during a medical procedure comprising repairing or replacing the heart valve in a patient.

Abstract: A hemodialysis system for operation with a blood source and a dialysate source, the system including: (i) a first machine portion including a blood pump; (ii) a blood cassette operatively connected to the blood pump such that the blood pump can pump blood through the blood cassette when the blood cassette is in fluid communication with the blood source; (iii) a dialyzer fluidly connected to the blood cassette; (iv) a second machine portion separate from the first machine portion, the second machine portion including a dialysate pump; and (v) a dialysate cassette separate from the blood cassette, the dialysate cassette operatively connected to the dialysate pump such that the dialysate pump can pump dialysate through the dialysate cassette when the dialysate cassette is in fluid communication with the dialysate source, the dialysate cassette being fluidly connected to the dialyzer.

Abstract: A dialysis system including a dialysis machine including a blood pump actuator, dialysate pump actuator, a blood valve actuator and a dialysate valve actuator; and a disposable cassette operable with the dialysis machine, the disposable cassette including: (i) a housing, (ii) a dialysate pump portion of the housing configured to operate with the dialysate pump actuator, (iii) a blood valve portion of the housing configured to operate with the blood valve actuator, (iv) a dialysate valve portion of the housing configured to operate with the dialysate valve actuator, (v) a dialyzer supported by the housing, the dialyzer including a dialysate inlet and a dialysate outlet, (vi) a first dialysate connection extending externally from the housing to the dialyzer inlet, and (vii) a second dialysate connection extending externally from the housing to the dialyzer outlet.

Abstract: Systems and methods are provided for automatically adjusting the operational parameters of a blood separation procedure. A blood separation device has an inlet for passing fluid thereinto and an outlet for removing fluid therefrom. A pump system is provided for moving fluid into and out of the device. In use, blood is conveyed into the device, where platelets are separated from at least a portion of the blood. A controller determines the amount of platelets in the device. Based at least in part on the amount of platelets in the device, corrective action is taken to avoid platelet aggregation in the device. The corrective action may be conveying an elevated amount of anticoagulant into the blood and/or the device and may be initiated when the determined amount of platelets approaches, meets, or exceeds a threshold predicted likelihood of platelet aggregation.

Abstract: Control methods of a dialysis machine for allowing the dialysate-side detection of a recirculation in an arteriovenous shunt of a patient during ongoing hemodialysis are described. A sensor is arranged downstream of a dialyser and detects a change of a physicochemical parameter PD of outflowing dialysis fluid. Control elements are provided to guide the dialysis fluid in a selected manner through the dialyser or pass it by.

Abstract: Apparatus and methods for providing extracorporeal blood circulation and oxygenation control include multi-stage de-airing of blood to provide automated cardiopulmonary replacement to preserve the viability or one or more organs in a clinically dead organ donor or harvested donor organ for subsequent transplantation to an organ receiver patient.

Abstract: An air purging method includes: (a) detecting a low fluid level in a blood circuit indicating a high amount of air in the blood circuit; (b) stopping a blood pump; (c) closing a venous patient line; (d) opening a blood circuit air vent valve and a drain valve; and (e) running the blood pump to meter air through the air vent valve and the drain valve to a drain.

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

Abstract: An artificial kidney that regenerates dialysate includes: a catheter having an inflow lumen and an outflow lumen for communication with a peritoneal cavity of a patient; a fluid circuit in fluid communication with the catheter for circulating dialysate into, through and out of the peritoneal cavity; a pump configured to circulate the dialysate; a cleaning cartridge coupled to the fluid circuit for removing solutes from the dialysate, including a therapeutically effective amount of urea from the dialysate as the dialysate circulates along the fluid circuit; and wherein the fluid circuit is configured to receive a volume of ultrafilterate removed from the patient, such that the pump can mix the ultrafiltrate volume with the dialysate to an increase an overall therapy fluid volume.

Abstract: According to the present invention, a dialysis fluid pump comprises: a housing having an accommodating space formed therein; a dialysis fluid supply tube and a dialysis fluid recovery tube, at least a portion of each of which is accommodated in the accommodating space; a cam rotatably installed in the accommodating space; a motor for rotating the cam; and a first backflow pressure preventer and a second backflow pressure preventer adapted to be mobile in the accommodating space and be pushed by the cam. The dialysis fluid supply tube is made of a flexible material which can be contracted or relaxed, and one end thereof is connected to a dialysis fluid supply tank and the other end thereof is connected to a hemodialysis filter. The dialysis fluid recovery tube is made of a flexible material which can be contracted or relaxed, and one end thereof is connected to a dialysis fluid recovery tank and the other end thereof connected to the hemodialysis filter.

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

Abstract: An extracorporeal blood system includes: an extracorporeal blood machine; an arterial line extending from the extracorporeal blood machine; a venous line extending from the extracorporeal blood machine; and an access disconnection circuit for detecting a disconnection of at least one of the arterial or venous lines from a patient, the access disconnection circuit including (i) a signal generation source having first and second signal generation source electrical lines each in electrical communication with blood traveling through one of the arterial or venous lines, (ii) a conductive pathway electrically communicating blood traveling through the arterial line with blood traveling through the venous line, and (iii) a signal processing unit positioned and arranged to process a signal generated by the source to detect the disconnection of the at least one of the arterial and venous lines.

Abstract: A machine-readable medium with instructions for pumping blood from a patient's blood stream into an access line, introducing an anticoagulant solution into the pumped blood, filtering the pumped blood and delivering it to a return line, introducing a substitution fluid into the pumped blood, introducing a calcium and magnesium solution into the blood traveling through the return line, and returning the blood back to the patient's blood stream.