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

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

Abstract: This invention provides a method and apparatus for calculating a hemodialysis parameter, especially blood access flow rate, using multiple dialysance values. The dialysance values may be calculated based upon either sodium or urea concentrations. One dialysance value can be determined for conditions in which a patient's arterial line withdraws blood from an upstream location in a patient's fistula and treated blood is returned by a venous line to a downstream location in a patient's fistula. The second dialysance value can be determined when the lines have been reconfigured so that the arterial line withdraws blood from a downstream portion of a patient's fistula and the venous line returns treated blood to an upstream portion of a patient's fistula.

Abstract: The present invention provides a blood transfusion system having valve circuit, for transfusion of blood to a patient, said system comprising a Y-Shaped connector comprising of three arm [7, 16(a) and 16(b)] and a junction (9), wherein arm 7 is connected to the patient at its one end and to the junction (9) at its other end, arm 16(a) is connected to the junction (9) at its one end and to a waste-blood suction syringe (10) at its other end through a valve (11), an outlet is being provided in the arm 16(a) between the valve 11 and the waste-blood suction syringe for dispensing the waste blood, arm 16(b) is connected to the junction (9) at its one end and to a fresh-blood supplying syringe (13) at its other end through a valve (14), a fresh-blood supplying means is being connected in the arm 16(b) between the valve 14 and the fresh-blood supplying syringe through a valve (15), and syringes (10 and 13) are being operated synchronously.

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

Abstract: Apparatus for processing blood in an extracorporeal circuit with automatic flow control is provided in which error conditions are sensed and system operation is modulated responsive to the error conditions. The apparatus includes an extracorporeal blood processing system, at least one sensor that senses the presence or absence of gas or monitors venous pressure, and a controller operably coupled to the blood processing system to selectively reduce pump speed or to reconfigure flow paths within the blood processing system responsive to the sensor output.

Abstract: Systems and related methods pump fluid through a pump. The pump comprises a pump chamber, which is responsive to applied pressures to convey fluid. The systems and methods place an electrode in electrical conductive contact with fluid in the pump chamber which, in use, is coupled to an electrical source. The electrode generates an electrical field in the pump chamber that varies according volume of fluid in the pump chamber. The systems and methods register variations in the electrical field as fluid is conveyed through the pump chamber.

Abstract: An endovascular system for arresting a patient's heart and maintaining the patient on cardiopulmonary bypass. A venous cannula, venting catheter and an aortic occlusion device are all coupled together so that the blood drawn into each of these catheters may be fed to a pump. A manifold has valves which control flows through the venous cannula, venting catheter and aortic occlusion device. A blood storage element is also provided so that the amount of blood in the perfusion circuit may be varied if necessary. The blood storage element is preferably positioned in parallel with the pump so that the pump may be used to add and remove blood to and from the blood storage element.

Abstract: An infusion control device controls infusion of a liquid in an extracorporeal blood circuit having an arterial pipe connected to an inlet of a blood compartment of a filter and a venous pipe connected to an outlet of the blood compartment. The arterial pipe is also connected to a pre-dilution pipe of an infusion circuit, and the venous pipe is also connected to a post-dilution pipe of said infusion circuit. The infusion control device regulates and distributes an infusion flow rate in the arterial and venous pipes based on a monitoring of quantities that are directly correlated with the operating conditions of the filter.

Abstract: Programmable, fluid pressure actuated blood processing systems and methods are used in association a blood separation device. The systems and methods employ a cassette, which contains several preformed, pneumatically actuated pump stations, several preformed fluid flow paths, and several preformed, pneumatically actuated valves in the fluid flow paths. The systems and methods also employ a programmable pneumatic actuator to hold the cassette and selectively apply pneumatic force to the valves and pump stations.

Abstract: A device for monitoring the access to the cardiovascular system of a patient undergoing an extracorporeal treatment of blood in a machine (1) comprising a treatment device (4) and an extracorporeal circuit (2), comprises: a voltage generator (16) for generating a potential difference between a part of the machine (1) and a first point (B) of a venous branch (8) of the extracorporeal circuit (2), connecting the patient to the treatment device (4); a detector (17) for detecting the value (dV) of a quantity that correlates with the electric current along at least one section (10a; 10b; 10c) of the venous branch (10) between the first point (B) and a venous needle (13) fitted at the end of the venous branch (8) and inserted in the vascular system of the patient (P); calculating means (15) for comparing the detected value (dV) with a reference range (I).

Abstract: A pulsating pumping unit for a fluid, particularly blood, includes means suitable to draw the fluid from an intake connector in order to send it to a outlet connector. The means are contained in an enclosure provided with valves connected to the inlet and the outlet. The valve connected to the outlet has at least one duct passing through the wall of the enclosure, is open at the end that leads into the portion of space. The pumping unit has a flow control element comprising a band of elastic material fixed to the outer wall of the enclosure at the edges, so as to have a blind portion which faces the exit port of the duct and a portion provided with holes which faces the outer wall.

Abstract: An intravascular device comprising an intra-aortic and extra-aortic component for perfusing the spinal arteries during thoracoabdominal surgeries. The intra-aortic component comprises a catheter having a shunt releasably mounted on a distal end of the catheter. An expandable occluder is disposed about the shunt for occluding the aortic lumen. The extra-aortic component comprises a tubular member having a lumen communicating with a first end and a second end. The first end is adapted for attachment to the shunt. The second end of the second tubular member is attached to a plurality of tubular branches. A cooler may be attached to the second tubular member for providing hypothermic perfusion. When the intra-aortic component is attached to the extra-aortic component, blood flows from the proximal aorta to the spinal arteries through the lumens of the tubular branches. Methods of using the device for spinal perfusion during thoracoabdominal surgeries herein are also disclosed.

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

Abstract: Automated systems and methods for withdrawing and replacing fluids in a patient are disclosed. The system withdraws blood from a donor or patient, separates the blood into two or more components and collects the separated component. A replacement fluid capable of at least partially providing the biological function of the separated component is infused into the patient.

Abstract: A flow cytometer containg a device for sampling cellular material within a body, comprising. The flow cytometer is adapted to mark cells within bodily fluid with a marker to produce marked cells, to analyze the marked cells, to sort the cells within the bodily fluid to produce sorted cells, and to maintain the sorted cells cells in a viable state.

Abstract: A device and methods for filtering blood clot particles from blood from patient undergoing treatment for a thrombotic condition with a catheter are described. The device comprises a housing having a first end defining a fluid port, an opposite end defining a suction port, and a valve member disposed between the fluid port and the reservoir. The valve member has a semipermeable membrane portion permeable to blood but impermeable to blood clot particles and a one way valve portion having an open position permitting passage of fluid and particles from the fluid port to the reservoir and a closed position blocking passage of particles between the reservoir and the fluid port.

Abstract: Apparatus and methods for removing gas from a blood handling system. A filter apparatus for monitoring and removing gas is provided comprising of a gas removal/blood filter, a sensor to sense the presence of gas, and a valve operably coupled to the sensor to evacuate gas from the apparatus when the sensor detects an accumulation of gas. When used with a previously known blood handling system, the present filter apparatus facilitates priming and the addition of additional blood handling elements during operation of the blood handling system.

Abstract: A tube system comprising a blood inlet line with an arterial patient connection and a blood return line with a venous patient connection, where a rinsing liquid inlet line branches off from the blood inlet line downstream from the arterial patient connection, and a rinsing liquid return line branches off from the blood return line upstream from the venous patient connection is filled while maintaining sterility in that rinsing liquid is pumped from a rinsing liquid container through the rinsing liquid inlet line, the blood inlet line, the blood return line and the rinsing liquid return line, establishing a liquid connection between the rinsing liquid inlet line and return line. The venous patient connection is sealed liquid-tight with a venous safety cap, and the arterial patient connection is sealed liquid-tight with an arterial safety cap. The safety caps are removed from the patient connections for connecting the tube system to the patient.

Abstract: Systems and methods for processing blood use at least one fluid activated pump and at least one fluid activated valve. The systems and methods apply positive and negative fluid pressures to operate the pump and valve. Different pressure conditions are applied to the pump and the valve, to insure that a valve used in conjunction with a pump is not overcome by the pressure applied to operate the pump, and that both the valve and pump are not overcome by normal system processing pressures.

Abstract: A flow cytometer containg a device for sampling cellular material within a body. The flow cytometer is adapted to mark cells within bodily fluid with a marker to produce marked cells, to analyze the marked cells, to sort the cells within the bodily fluid to produce sorted cells, to maintain the sorted cells cells in a viable state, and to remove the marker from the marked cells. Two marker removal devices are used in the flow cytomter.

Abstract: A flow diverting appliance has a flexible valve body to which a number of flow lines are connected. The valve body is deformed to create different flow paths within it. The valve body may be deformed, for example, by pinching it to define press-seals in an enclosed volume inside the valve body. The press seals divide the enclosed volume to form exclusive flow channels which allow communication between some flow lines and permit flow communication between other lines. The invention provides a way of making flow diverters part of a replaceable blood circuit which is fully hermetic and with no dead-end spaces which would allow blood to cagulate.

Abstract: A dialysis machine includes an extracorporeal blood circuit having an arterial pipe and a venous pipe respectively connected to an inlet and an outlet of a blood compartment of a filter. The blood compartment and a dialysis liquid compartment of the filter are separated by a semi-permeable membrane. The machine is configured to determine a sequence of infusion of a liquid in the extracorporeal blood circuit, from at least one characteristic value correlated with the concentration of the blood and/or a filtration efficiency of the filter, and to infuse the infusion solution in the arterial pipe and in the venous pipe in accordance with the determined infusion sequence.

Abstract: In a blood dialysis system including a source of substitution fluid (10) and a blood dialysis machine, a hemodiafiltration system having a first dialyzer (1) including a first blood compartment (4) having a first blood inlet which receives blood to be cleaned and a first blood outlet which discharges partially diafiltered blood and a first dialysate compartment (5) having a first dialysate inlet and a first dialysate outlet, means (8) for mixing the partially diafiltered blood with substitution fluid from the source to obtain a blood/substitution fluid mixture, and a second hemofilter (2) including a second blood compartment (11) having a second blood inlet which receives the blood/substitution fluid mixture and a second blood outlet which discharges filtered blood and a second permeate compartment (12) having a second permeate outlet.

Abstract: A single-use system for separating blood and producing platelet concentrates includes an elongated container for receiving blood from a patient. The container has a movable plunger mounted within the blood container for expressing blood fractions separated during centrifugation of the container through a first port mounted at one end of said container, a second port mounted on the plunger, and a third port mounted on a plunger rod attached to the plunger.

Abstract: A process for manufacturing an adsorbent for reducing the concentration of fibrinogen and/or fibrin in blood or blood plasma in which a carrier material, which is preferably a copolymer derived from (meth)acrylates and or (meth)acrylic acid amides, is activated by amination, and subsequently undergoes thermal treatment at a temperature of over 100° C. An adsorber for the purpose of reducing the concentration of fibrinogen and/or fibrin in blood or blood plasma may be produced from the adsorbent.

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

Abstract: A tubular set portion for circulating blood between a patient and an extracorporeal blood treatment device. The set portion has: an arterial tube for conveying blood from a patient toward the blood treatment device; a venous tube for conveying blood from the blood treatment device back towards the patient; and a pair of spaced, transverse tubes that each connect between the arterial tube and the venous tube, each of the tubes being capable of clamp sealing. The arterial and venous tubes are clamp sealable between the spaced, transverse tubes. Flow reversal on the patient's side of this device is possible by appropriate clamping of two opposed tube sections of the rectangular array which may be formed by the joined tube sections, while flow remains unchanged on the side of the tubular set portion that is connected to the extracorporeal blood treatment device.

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

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

Abstract: The present invention provides a blood transfusion system having valve circuit, for transfusion of blood to a patient, said system comprising a Y-Shaped connector comprising of three arm [7, 16(a) and 16(b)] and a junction (9), wherein arm 7 is connected to the patient at its one end and to the junction (9) at its other end, arm 16(a) is connected to the junction (9) at its one end and to a waste-blood suction syringe (10) at its other end through a valve (11), an outlet is being provided in the arm 16(a) between the valve 11 and the waste-blood suction syringe for dispensing the waste blood, arm 16(b) is connected to the junction (9) at its one end and to a fresh-blood supplying syringe (13) at its other end through a valve (14), a fresh-blood supplying means is being connected in the arm 16(b) between the valve 14 and the fresh-blood supplying syringe through a valve (15), and syringes (10 and 13) are being operated synchronously.

Abstract: A vacuum assisted venous blood reservoir has a controller that can sense pressure within a sealed blood chamber. The controller regulates the amount of vacuum within the chamber to control the level of blood in the venous reservoir. A safety valve is included to prevent blood from entering the vacuum line.

Abstract: The present invention is a cardiopulmonary bypass and extracorporeal oxygenation apparatus that provides a pulsatile blood flow output. The apparatus comprises: a primary pump, which primary pump is preferably a continuous pump; an oxygenator in fluid communication with the primary pump; a pulse wave generator in fluid communication with the oxygenator and positioned downstream from the primary pump. The pulse wave generator comprises: (i) a collapsible chamber having an inlet opening and an outlet opening formed therein; (ii) a first one-way valve connected to the inlet opening and positioned to permit the flow of blood from the primary pump through the collapsible chamber. A compression assembly is operatively associated with the collapsible chamber and configured to alternately compress said collapsible chamber and permit the expansion of the collapsible chamber.

Abstract: A tubular set is provided for the extracorporeal treatment of blood, for example hemodialysis. The set has a patient arterial line and a patient venous line, each line having a patient connector at one end thereof. Each patient line connects at its other end to a reversing flow valve. The valve also connects to respective first ends of a blood processing unit arterial line and a blood processing unit venous line. Each of the unit lines carry a connector at ends opposed to the first ends for connection respectively to arterial and venous ports of a blood processing device, typically a dialyzer. The reversing flow valve has a first position that respectively connects the patient and unit arterial lines with the patient and unit venous lines. The reversing flow valve has a second position that connects the patient arterial line with the unit venous line, and the unit arterial line with the patient venous line.

Abstract: A medical fluid passage switching apparatus comprising: at least, a rotatable shaft F; a cam C which is rotated in relation to the rotating movement of the shaft F to close and open divided tubes for determining a passage of a fluid; and a housing L having tube accepting holes I and so arranged to enable the holding of the cam C, is provided. More particularly, provided are such a medical fluid passage switching apparatus in a continuous ambulatory peritoneal dialysis (CAPD) system and a tube which is decreased in the diameter and/or thinned in the wall at a region where the cam or a combination of the cam and the clamp is engaged for closing and opening.

Abstract: Automated systems and method for processing blood and other fluids are disclosed. The systems and methods utilize a disposable fluid circuit mounted on a re-usable hardware component or module. The system withdraws blood from a donor or patient, separates the blood into two or more components and further processes or treats the separated component.

Abstract: A device for producing a gas-supersaturated fluid is provided. The device includes a chamber having a first inlet to receive a gas and a second and a third inlets to receive a fluid; and an outlet for removal of the produced gas-supersaturated fluid. The gas is received from a gas supply that maintains pressure within the chamber at a predetermined level. An atomizer nozzle is coupled to the third inlet to create fine droplets of fluid within the chamber into which gas diffuses to create the gas-supersaturated fluid. The device also includes a first valve coupled to the outlet of the chamber and a second valve coupled to the second inlet, the third inlet and an actuator assembly to control delivery of the fluid from the piston assembly into the chamber. The fluid is delivered into the chamber through the second inlet when the second valve is open and the fluid is delivered through the third inlet when the second valve is closed.

Abstract: Methods and devices for the removal of psoralens and psoralen photoproducts from blood products are described. The methods include contacting a psoralen- and irradiation-treated blood product with a resin capable of adsorbing psoralens and psoralen photoproducts. The removal process is particularly suitable for use with platelet concentrates and plasma because the process does not have a significant adverse effect on clotting factor function. The methods and devices can be incorporated with apheresis systems and other devices and procedures currently used to process blood products for transfusion.

Abstract: Devices for controlling the flow of fluid through plastic tubes, such as tubes which are part of a disposable blood donation tubing set are disclosed. The device comprises a clamp adapted for attachment with one or more other clamps to allow for easy flow control through two or more tubing segments.

Abstract: A flow diverting appliance has a flexible valve body to which a number of flow lines are connected. The valve body is deformed to create different flow paths within it. The valve body may be deformed, for example, by pinching it to define press-seals in an enclosed volume inside the valve body. The press seals divide the enclosed volume to form exclusive flow channels which allow communication between some flow lines and permit flow communication between other lines. The invention provides a way of making flow diverters part of a replaceable blood circuit which is fully hermetic and with no dead-end spaces which would allow blood to cagulate.

Abstract: The invention comprises a disposable tubing set (4) for connection to a rigid canister (2) that is maintained at a controlled reduced (vacuum) pressure.

Abstract: An apparatus controls movement of fluids during an extracorporeal blood treatment session. A hollow cassette enclosure has a plurality of fluid input ports for receiving fluids into the enclosure and a plurality of fluid output ports for expelling fluids from the enclosure. Internal fluid passageways disposed within the hollow enclosure are provided for coupling together the fluid input ports, and the fluid output ports. At least one internal valve is disposed within the hollow enclosure for controlling movement of the fluid within the hollow enclosure. A filter is integrated into the cassette to filter the blood passing therethrough.

Abstract: An implantable fluid valve for the adjustable limitation of the fluid pressure in the brain of a patient, has all valve component parts composed of non-magnetic material, thereby making the valve MR-compatible.

Abstract: An obturator prevents the tips or flaps of a duck-bill valve from self-adhering during storage or during sterilization procedures. The obturator holds the tips apart until the end-user is ready to use the valve. The duck-bill valve is used as an air outlet valve in blood reservoirs.

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

Abstract: A diverter for selectively providing fluid communication between ports to a common chamber is disclosed. The diverter includes a resilient deformable common chamber having a plurality of ports. Upon deforming the common chamber along a given line, fluid communication between selected ports is precluded, which flow preclusion is used to effectively reverse a flow direction in a circuit connected to the diverter.

Abstract: Methods and apparatus filter and reinfuse aspirate removed from body lumens following a medical procedure. Evacuation of harmful material such as blood clot or plaque from a blood vessel can be combined with filtering of blood from the unwanted material, allowing the blood to be reinfused back into the patient's system through various means, thereby minimizing the effects of blood loss to the patient.

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

Abstract: A tubular set is provided for use with extracorporeal treatment of blood. The set comprises: a flow reversing valve having a patient arterial line and a patient venous line each separately connected to one side of the valve. A unit arterial line and a unit venous line are each separately connected to the other side of the valve. The patient arterial line connects with the unit arterial line in a first position of a valve, and the patient venous line connects with the unit venous line in the same first valve position. The patient arterial line connects with the patient venous line in a second position of a valve, while the patient venous line connects with the unit arterial line in the same second valve position. The flow reversing valve is movable between the first and second positions by relative rotation of part of the valve and adjacent portions of the respective lines.

Abstract: A diverter for selectively providing fluid communication between ports to a common chamber is disclosed. The diverter includes a resilient deformable common chamber having a plurality of ports. Upon deforming the common chamber along a given line, fluid communication between selected ports is precluded, which flow preclusion is used to effectively reverse a flow direction in a circuit connected to the diverter.