Abstract: Peritoneal dialysis admixing and/or treatment devices, methods, and systems are disclosed. The systems, methods, and devices provide high-level guarantees of sterility and employ relatively inexpensive disposable components to provide pumping. Disclosed systems, methods, and devices and features thereof are adapted for point of use generation of medicament. In particular, admixing systems that employ independently-replaceable long term concentrate are disclosed. Features are directed to assurance of sterility and accurate admixing of water and concentrate to generate ready-to-use medicaments and other benefits.

Abstract: Fluid couplings prevent or discourage misconnection of fluid lines. In embodiments, a coupling device includes multiple male and female connectors that are joined to a common line. The coupling device is mated to a matching coupling device only when all the multiple male and female connectors are properly joined. If any of the connectors is not properly mated to a corresponding one, the coupling will leak, since the connectors on each side are joined to a furcating channel. In embodiments, the coupling devices are made unique by providing an arrangement of the connectors, number of connectors, shape of connectors or arrangement of interfering connector parts that ensure that any attempt to improperly couple two fluid lines will result in the incomplete mating and thereby cause leakage of the fluid, failure of the coupling to engage, or otherwise cause the attempt to connect to fail.

Abstract: A flow switch device includes a flow switch with four ports oriented at 90 degree intervals around a center of the flow switch. The flow switch is of a type that forms selectable flow passages between ports separated by 90 degrees and blocks flow between ports separated by 180 degrees in each of multiple selected positions. Two of the ports are connected to fixed flow passages and each of the fixed flow passages defines a flow path toward a remote port separated from each of the fixed flow passages by 180 degrees so that each of the fixed flow passages and a respective remote port are positioned in pairs on opposite sides of the flow switch.

Abstract: A medical treatment device is configured to be used during a treatment session at a first location and includes a medical treatment component configured to perform at least one of hemodialysis, hemofiltration, and peritoneal dialysis on a patient during the treatment session at the first location. The device also includes a monitoring system configured to receive data from one or more sensors connected to the monitoring system, and to confirm a presence of an authorized helper at the first location. A user interface permits an operator to control functions of the medical treatment component and the monitoring system is configured to perform the presence confirmation automatically and at the predefined time intervals during the treatment session. The monitoring system is also configured to generate an alarm and to cause the medical treatment component to go into a failsafe operational mode.

Abstract: According to embodiments, priming systems, methods, and devices are disclosed which allow medical treatment devices which pump fluid to be primed with minimal operator intervention and a high level of convenience. A blood circuit with a filter fitted with one or more air vents on a non-blood compartment is attached to a treatment system and priming fluid pumped slowly through the blood circuit in a loop. The source of fluid may be elevated, or the pumping may generate pressure, such that priming fluid is forced through the membrane of the filter and out the air vent(s). In embodiments, the vents are hydrophobic which prevent fluid from being ejected, so the priming system can run without intervention.

Abstract: A medical treatment system includes a disposable fluid circuit that includes a water inlet and a batch container arranged to hold a mixture, the mixture including water that is received from the water inlet and at least one concentrate. The fluid circuit also includes a drain line for draining fluid from the disposable fluid circuit, and a manifold with a plurality of fluid lines, the manifold connecting the water inlet, the batch container, a source of the at least one concentrate, and the drain line. A source of purified water supplies the purified water to the water inlet and a sensor detects a property of fluid in the disposable fluid circuit. A controller controls flowing of a first fluid followed by displacement by a second fluid causing the first fluid to flow to the sensor.

Abstract: A medicament preparation system includes a water purification module and a medicament proportioning module that is interoperable with a replaceable fluid circuit. The fluid circuit includes a purified water inlet, a product medicament outlet, and a plurality of pumping tube segments. At least a first concentrate container is connected by at least a portion of the fluid circuit to the product medicament output and a first concentration measurement sensor station is positioned in a flow path. A controller is programmed to calculate iteratively a concentration of a first concentrate from the first concentrate container and the purified water from a signal generated by the first concentration measurement sensor station and to regulate one or both of a first pumping actuator engaged with the first pumping tube segment and a second pumping actuator engaged with the second pumping tube segment, responsively to the concentration of the first concentrate and water.

Abstract: Simple-to-use systems, methods, and devices for priming replacement blood treatment devices, for swapping the blood treatment devices out, for replacing swapped-out blood treatment devices, and other related operations are described. In embodiments, a blood treatment device can be primed while a therapy is still running. When the replacement blood treatment device is needed, the therapy can be stopped momentarily (less than a minute) for the rapid and safe swap of the blood treatment device. Blood loss can be minimized. The down time from therapy can be minimized.

Abstract: Peritoneal dialysis admixing and/or treatment devices, methods, and systems are disclosed. The systems, methods, and devices provide high-level guarantees of sterility and employs relatively inexpensive disposable components to provide pumping. Disclosed systems, methods, and devices and features thereof are adapted for point of use generation of medicament. In particular admixing systems that employ independently-replaceable long term concentrate are disclosed. Features are directed to assurance of sterility and accurate admixing of water and concentrate to generate ready-to-use medicaments and other benefits.

Abstract: A pressure measurement system includes a pressure pod with two chambers separated by a diaphragm such that a deformation/movement of the diaphragm is indicative of a difference between the pressures of the two chambers. Such deformation/movement is detected by a device that has no physical contact with the diaphragm, for example, by an optical detector that detects a change in the shape of the diaphragm or a movement of a protrusion on the diaphragm.

Abstract: A medicament preparation system includes a water purification module and a medicament proportioning module that is interoperable with a replaceable fluid circuit. The fluid circuit includes a purified water inlet, a product medicament outlet, and a plurality of pumping tube segments. At least a first concentrate container is connected by at least a portion of the fluid circuit to the product medicament output and a first concentration measurement sensor station is positioned in a flow path. A controller is programmed to calculate iteratively a concentration of a first concentrate from the first concentrate container and the purified water from a signal generated by the first concentration measurement sensor station and to regulate one or both of a first pumping actuator engaged with the first pumping tube segment and a second pumping actuator engaged with the second pumping tube segment, responsively to the concentration of the first concentrate and water.

Abstract: A medical treatment system includes a disposable fluid circuit that includes a water inlet and a batch container arranged to hold a mixture, the mixture including water that is received from the water inlet and at least one concentrate. The fluid circuit also includes a drain line for draining fluid from the disposable fluid circuit, and a manifold with a plurality of fluid lines, the manifold connecting the water inlet, the batch container, a source of the at least one concentrate, and the drain line. A source of purified water supplies the purified water to the water inlet and a sensor detects a property of fluid in the disposable fluid circuit. A controller controls flowing of a first fluid followed by displacement by a second fluid causing the first fluid to flow to the sensor.

Abstract: A method of making a needle guard includes providing a mold having a portion defining a volume, the volume being a hollow cylinder with non-uniform walls with a pair of slots therein, the slots being open at one end and closed at the other end, the pair of slots having a major portion of constant width. The walls are thicker at the other end than at the one end. The method includes filling the volume with polymer and releasing a molded part from said mold and cooling a molded part resulting from the filling and releasing such that temperature that the widths of the pair of slots is non-uniform after cooling. The needle guard has upper and lower jaws defining a channel and coming together at a hinge. A winged needle can be inserted between the jaws, with the wings of the winged needle passing through slots between the jaws.

Abstract: Simple-to-use systems, methods, and devices for priming replacement blood treatment devices, for swapping the blood treatment devices out, for replacing swapped-out blood treatment devices, and other related operations are described. In embodiments, a blood treatment device can be primed while a therapy is still running. When the replacement blood treatment device is needed, the therapy can be stopped momentarily (less than a minute) for the rapid and safe swap of the blood treatment device. Blood loss can be minimized. The down time from therapy can be minimized.

Abstract: A fluid treatment plant has a filter module including at least a first filter and a second filter connected in series and connectable to a supply of fluid. A pump is fluidly connected to the filter module and a controller with a fluid quality sensor is connected to detect a quality of the fluid between the first filter and the second filter. A filter module detector is connected to the controller configured to uniquely detect a filter module connected to the pump, and the controller is controls the pump responsively to a signal from the fluid quality sensor and the module detector. The controller is configured to continue pumping based on output of the quality sensor and/or based on output from the filter module detector.

Abstract: A blood treatment system with pressure sensors may be configured to control blood flow to and from the patient and use readings of the pressure sensors to determine a change in a pressure drop across a flow restriction in the blood circuit to estimate a condition of the machine or the patient, or outputting data responsive to the estimation. Further embodiments employ measurement of pressure drop to detect abnormal viscosity or viscosity variations in order to detect possible infection.

Abstract: The disclosed subject matter relates to extracorporeal blood processing or other processing of fluids. Volumetric fluid balance, a required element of many such processes, may be achieved with multiple pumps or other proportioning or balancing devices which are to some extent independent of each other. This need may arise in treatments that involve multiple fluids. Safe and secure mechanisms to ensure fluid balance in such systems are described.

Abstract: A pressure measurement system includes a pressure pod with two chambers separated by a diaphragm such that a deformation/movement of the diaphragm is indicative of a difference between the pressures of the two chambers. Such deformation/movement is detected by a device that has no physical contact with the diaphragm, for example, by an optical detector that detects a change in the shape of the diaphragm or a movement of a protrusion on the diaphragm.

Abstract: A method of making a needle guard includes providing a mold having a portion defining a volume, the volume being a hollow cylinder with non-uniform walls with a pair of slots therein, the slots being open at one end and closed at the other end, the pair of slots having a major portion of constant width. The walls are thicker at the other end than at the one end. The method includes filling the volume with polymer and releasing a molded part from said mold and cooling a molded part resulting from the filling and releasing such that temperature that the widths of the pair of slots is non-uniform after cooling. The needle guard has upper and lower jaws defining a channel and coming together at a hinge. A winged needle can be inserted between the jaws, with the wings of the winged needle passing through slots between the jaws.

Abstract: A fluid treatment plant has a filter module including at least a first filter and a second filter connected in series and connectable to a supply of fluid. A pump is fluidly connected to the filter module and a controller with a fluid quality sensor is connected to detect a quality of the fluid between the first filter and the second filter. A filter module detector is connected to the controller configured to uniquely detect a filter module connected to the pump, and the controller is controls the pump responsively to a signal from the fluid quality sensor and the module detector. The controller is configured to continue pumping based on output of the quality sensor and/or based on output from the filter module detector.