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.

Systems and methods for monitoring the presence of blood in an extracorporeal blood circuit are disclosed. A control unit, which is connected to a blood detector and to one or several pressure sensors, determines whether blood is present in the membrane device based on the differential pressure there over and generates a signal if the presence of blood as detected by the blood detector and the presence of blood as determined based on the differential pressure value do not coincide with each other.

An automated peritoneal dialysis system provides various features including prescription-driven dialysis fluid preparation, an integrated disposable fluid circuit, and sensor capabilities that allow accurate filing and draining control with high safety margins. Features include a peritoneal fluid circuit with a pressure sensor at either end and methods and devices for using the pressure signals. Other features and embodiments are disclosed.

A dialysis system includes a source of water; a concentrate for mixing with the water a disposable set including a pumping portion, a water line in fluid including a filter for filtering the water, a concentrate line in fluid communication with the source of water and the pumping portion; and a medical fluid delivery machine including a pump actuator operable with the pumping portion, a pressure sensor, and a control unit programmed to cause (i) the pump actuator to pump water to wet a membrane of the filter, thereafter remove at least some of the water from the filter, and pressurize a portion of the water line leading from the pumping portion to the filter, (ii) the pressure sensor to sense pressure in the pressurized portion of the water line, and (iii) an analysis of the sensed pressure to be performed to evaluate the integrity of the filter.

A peritoneal dialysis system includes a water purifier, a cycler, and a disposable set operable with the cycler. The disposable set includes a pumping cassette including a water inlet port, a heater/mixing container in fluid communication with the pumping cassette, a water accumulator, a first water line segment, and a second water line segment. The first water line segment is in fluid communication with the water inlet port and the water accumulator. Additionally, the second water line segment is in fluid communication with the water accumulator and the water purifier.

A peritoneal dialysis system includes a disposable set, source(s) of concentrate(s), a water purifier, a sensor, and a control unit. The disposable set includes a water port, an inlet port, a drain port, a water line in fluid communication with the water port, a drain line in fluid communication with the drain port, and a container to hold a dialysis fluid prepared by mixing water and the concentrate(s). The source(s) of concentrate(s) are in fluid communication with the inlet port, and the water purifier is configured to purify water and feed the water towards the water port so the sensor can detect a fluid property. The control unit is configured to deliver dialysis fluid mixed in the disposable set to the drain line and water purified by the water purifier along the water line, into the disposable set, and out the drain line to push dialysis fluid to the sensor.

Methods of combined sterilization and integrity testing of dialyzers such as hollow fiber dialyzers are disclosed. Sterilization and integrity testing may be performed by treating the dialyzer with a sterilization fluid for sterilizing at least the blood-side compartment of the dialyzer and for wetting the dialysis membrane of the dialyzer with the sterilization fluid, and carrying out an integrity testing of the dialysis membrane wetted with the sterilization fluid, wherein the sterilization fluid is selected from aqueous solutions containing peroxide and/or ozone, the peroxide being selected from peroxides which disintegrate into water, oxygen and/or volatile organic compounds, and from aqueous solutions containing chlorine, bromine and/or iodine.

A dialysis system includes a source of water; a concentrate for mixing with the water a disposable set including a pumping portion, a water line in fluid including a filter for filtering the water, a concentrate line in fluid communication with the source of water and the pumping portion; and a medical fluid delivery machine including a pump actuator operable with the pumping portion, a pressure sensor, and a control unit programmed to cause (i) the pump actuator to pump water to wet a membrane of the filter, thereafter remove at least some of the water from the filter, and pressurize a portion of the water line leading from the pumping portion to the filter, (ii) the pressure sensor to sense pressure in the pressurized portion of the water line, and (iii) an analysis of the sensed pressure to be performed to evaluate the integrity of the filter.

A mechanical kidney transplant may include four modules to interconnect and clean blood. Blood flowing through at least one of the modules flows through dialyzer fiber/tubes, while an area surrounding that fiber/tubes receives a flow of physiological resin gel of a design that will remove impurities from the blood. A subsystem of one or more sensors (a) detects and sets an alarm condition when the physiological resin gel is degraded and may need partial or full replacement, and/or (b) detects and sets an alarm condition if blood leakage has occurred within the module.

A method and apparatus for evaluating a condition of a water purification system (40, 110) comprising a water purification apparatus (110) arranged to output purified water through an outlet (128) and through at least one sterilizing grade filter (70a, 70b) of a line set (40) fluidly connected to the outlet (128), the method comprises: monitoring a flow rate (S1) correlated with the flow rate of the purified water flowing through the at least one sterilizing grade filter (70a, 70b); monitoring a pressure (S2) correlated with the pressure of the purified water flowing to the at least one sterilizing grade filter (70a, 70b); and evaluating (S3) a condition of the water purification system based on a relationship between the monitored flow rate and the monitored pressure.