Abstract: A method for performing a peritoneal dialysis therapy includes performing a plurality of peritoneal dialysis cycles for a patient and tracking an amount of dialysis fluid provided by at least one dialysis fluid pump during the plurality of peritoneal dialysis cycles. The method also includes determining an amount of ultrafiltrate (“UF”) removed from the patient based on the amount of dialysis fluid provided by the at least one dialysis fluid pump. The method further includes updating a UF trend using previous amounts of UF removed from the patient and the amount of UF removed from the patient during the most recent dialysis treatment and generating an alert if the UF trend changes by more than a preset percentage.

Abstract: A system and method for balancing flows of renal replacement fluid is disclosed. The method uses pressure controls and pressure sensing devices to more precisely meter and balance the flow of fresh dialysate and spent dialysate. The balancing system may use one or two balancing devices, such as a balance tube, a tortuous path, or a balance chamber.

Abstract: A sterile solution product bag for lyophilizing includes a bladder, a first stem having a first stem inlet end and a first stem outlet end. The first stem outlet end is fluidly connected to the bladder and the first stem inlet end is adapted to receive a liquid. A first filter is disposed in-line with the first stem and includes a first filter membrane, a first filter open end, and a first filter closed end. The first filter closed end is disposed between the first stem inlet end and the first stem outlet end and the first filter open end is disposed in proximity to the first stem inlet end. A second stem having a second stem inlet end fluidly connected to the bladder and a second stem outlet end adapted to receive a vapor. A second filter is disposed within the second stem and includes a filter membrane.

Abstract: A system for reconstituting and sterilizing a concentrate includes a mixing container, a filtration device, and a product bag. The a mixing container has an inlet port and outlet port in fluid communication with a mixing chamber disposed between the inlet port and the outlet port. The mixing chamber is adapted to contain a product concentrate. The filtration device has an inlet and an outlet, the inlet of the filtration device coupled to the outlet port of the mixing container. The filtration device includes a filter membrane with a nominal pore size in a range of approximately 0.1 ?m to approximately 0.5 ?m. The product bag has an inlet port coupled to the outlet of the filtration device, and has a bladder defining an empty sterile chamber for receiving sterilized and reconstituted product resulting from mixing a diluent with a product concentrate in the mixing chamber to obtain a mixture then introduced through the filtration device to obtain the reconstituted and sterilized product.

Abstract: A handheld personal communication apparatus for dialysis includes a reader to read a marking displayed on a dialysis fluid container to acquire data concerning a dialysis fluid type. The apparatus also includes a processor that uses the dialysis fluid type to determine a dialysis dwell time for at least one cycle of a dialysis therapy, the dialysis dwell time being a time to achieve, over the at least one cycle, at least one of (a) a specified ultrafiltrate level, (b) a urea removal level, or (c) a creatinine removal level. The apparatus further includes an output interface that provides an indication to the patient of a completion of the dialysis dwell time.

Abstract: A hemodiafiltration system with a disposable pumping unit is disclosed. An example system includes a medical fluid pump actuator, a medical fluid heater, a blood filter and a disposable unit. The example disposable unit includes a medical fluid cassette portion including a medical fluid cassette housing configured to be operatively connected to the medical fluid pump actuator to pump medical fluid through the medical fluid cassette portion when the medical fluid cassette portion is in fluid communication with a medical fluid source. The example medical fluid cassette portion is also configured to be placed in fluid communication with the blood filter and with an extracorporeal circuit communicating with the blood filter, the fluid communication enabling hemodiafiltration to be performed. The example disposable unit also includes a heater bag configured to be placed in operable communication with the medical fluid heater and in fluid communication with the medical fluid cassette portion.

Abstract: A method of providing a plurality of filled product bags of sterile fluid includes positioning a bag assembly onto a filling machine. The bag assembly includes a tube, a filter assembly, bladders, and stems. A stem is attached to a bladder, forms a fluid passageway, fluidly connects to the tube, and provides fluid communication into the bladders. The method includes fluidly coupling an inlet of the filter assembly to a connection line in fluid communication with a fluid source, and filling the bag assembly with a fluid. Filling the bag assembly includes passing the fluid through the filter assembly, the fluid passageway, and into the bladder. The method includes sealing the fluid passageway at a location between the tube and the bladders. The method includes cutting the stem to form a partially filled product bag having the sealed passageway. The method includes performing an integrity test on the filter assembly.

Abstract: A handheld personal communication apparatus for dialysis includes a reader to read a marking displayed on a dialysis fluid container to acquire data concerning at least one of a dialysis fluid type or a dialysis fluid volume from the marking; a processor using the at least one of the dialysis fluid type or the dialysis fluid volume to determine a dialysis dwell time for at least one cycle of a dialysis therapy, the dialysis dwell time being a time to achieve, over the at least one cycle, at least one of (a) a specified ultrafiltrate level, (b) a urea removal level, or (c) a creatinine removal level; and an output interface providing an indication to the patient of a completion of the dialysis dwell time.

Abstract: A sterile solution product bag includes sterilization grade filter integrated directly into the product bag such that microbial and particulate matter filtration can be performed using the filter directly at the point of fill. The filter can include a hollow fiber filter membrane contained in a stem connected to a bladder of the product bag.

Abstract: A gravity fed peritoneal dialysis (“PD”) machine includes: a frame configured to be set on a supporting surface; at least one load cell; a scale platform supported by the frame via the at least one load cell positioned between the frame and the scale platform; a drain container support in mechanical communication with and extending downwardly from the scale platform, the machine configured such that when the frame is set on the supporting surface, at least one fresh PD fluid supply container is supportable by the scale platform above the at least one load cell and at least one used PD fluid drain container is supportable by the drain container support below the at least one load cell, so that a combined weight of fresh PD fluid and used PD fluid may be sensed by the at least one load cell.

Abstract: A syringe system includes a syringe and a filtration device connected to the syringe for sterilizing and introducing fluid into the syringe. The syringe includes a syringe barrel having a proximal end defining a barrel opening, a distal end defining a delivery opening, a bore extending between the proximal end and the distal end, and a stopper disposed in the bore of the syringe barrel. The filtration device has an inlet and an outlet coupled in fluid communication with the delivery opening at the distal end of the syringe barrel. The filtration device includes a stem and a filter membrane disposed in line with the stem. The filter membrane optionally has a plurality of pores each with a nominal pore size in a range of approximately 0.1 ?m to approximately 0.5 ?m such that a pharmaceutical fluid can be introduced as a sterilized pharmaceutical fluid into the bore of the syringe barrel by passing through the filtration device.

Abstract: A hemodiafiltration system with a disposable pumping unit is disclosed. An example system includes a medical fluid pump actuator, a medical fluid heater, a blood filter and a disposable unit. The example disposable unit includes a medical fluid cassette portion including a medical fluid cassette housing configured to be operatively connected to the medical fluid pump actuator to pump medical fluid through the medical fluid cassette portion when the medical fluid cassette portion is in fluid communication with a medical fluid source. The example medical fluid cassette portion is also configured to be placed in fluid communication with the blood filter and with an extracorporeal circuit communicating with the blood filter, the fluid communication enabling hemodiafiltration to be performed. The example disposable unit also includes a heater bag configured to be placed in operable communication with the medical fluid heater and in fluid communication with the medical fluid cassette portion.

Abstract: A product bag includes a bladder and an elongated filtration device. The bladder includes opposing first and second film layers defining a product chamber. The first and second film layers are sealed together along a perimeter seal extending along at least a portion of a perimeter of the bladder. The elongated filtration device includes a housing, a filtration membrane disposed in the housing, an inlet adapted for receiving a fluid to be filtered, and an outlet in fluid communication with the product chamber. A majority of the elongated filtration device is embedded between the first and second film layers of the perimeter seal of the bladder to provide for a compact form factor.

Abstract: A fluid preparation apparatus for a renal failure treatment is disclosed. In an example, the fluid preparation apparatus includes an inlet configured to receive water from a water source and a fluid line fluidly connected to the inlet. The apparatus also includes a pump fluidly connected to the fluid line. The pump is configured to pump concentrate from a concentrate container to mix with the water to form a fluid mixture. The apparatus further includes a sensor configured to measure a composition characteristic of the fluid mixture. Additionally, the apparatus includes a controller operably coupled to the pump, the sensor, and a valve. The controller is configured to receive a composition characteristic value from the sensor, and cause the valve to route the fluid mixture for the renal failure treatment when the composition characteristic value indicates that the fluid mixture is suitable for the renal failure treatment.

Abstract: A system for monitoring water quality for dialysis, dialysis fluids, and body fluids treated by dialysis fluids, is disclosed. The system uses microelectromechanical systems (MEMS) sensors for detecting impurities in input water or dialysis fluid, and in the prepared dialysate. These sensors may also be used to monitor and check the blood of the patient being treated. These sensors include ion-selective sensors, for ions such as ammonium or calcium, and also include amperometric array sensors, suitable for ions from chlorine or chloramines, e.g., chloride. These sensors assist in the monitoring of water supplies from a city water main or well. The sensors may be used in conjunction with systems for preparing dialysate solutions from water for use at home or elsewhere.

Abstract: A renal failure blood therapy system includes a memory device storing a therapy target for a patient. The system also includes a processor configured to receive the therapy target for the patient, receive a desired solute concentration for the patient, and apply the therapy target and the desired solute concentration as inputs to an optimization routine. The processor is also configured to execute the optimization routine to determine at least one dialysis therapy prescription specifying at least a dialysis therapy duration, a dialysis therapy frequency, and at least one of a dialysis therapy blood flow rate or a dialysis therapy dialysate flow rate. The processor is further configured to display the at least one dialysis therapy prescription for confirmation or selection by a clinician and transmit the selected or confirmed dialysis therapy prescription to a dialysis machine for a subsequent dialysis treatment for the patient.

Abstract: A method for performing a peritoneal dialysis therapy includes performing a plurality of peritoneal dialysis cycles for a patient and tracking an amount of dialysis fluid provided by at least one dialysis fluid pump during the plurality of peritoneal dialysis cycles. The method also includes determining an amount of ultrafiltrate (“UF”) removed from the patient based on the amount of dialysis fluid provided by the at least one dialysis fluid pump. The method further includes updating a UF trend using previous amounts of UF removed from the patient and the amount of UF removed from the patient during the most recent dialysis treatment and generating an alert if the UF trend changes by more than a preset percentage.

Abstract: A system for reconstituting and sterilizing a concentrate includes a mixing container, a filtration device, and a product bag. The a mixing container has an inlet port and outlet port in fluid communication with a mixing chamber disposed between the inlet port and the outlet port. The mixing chamber is adapted to contain a product concentrate. The filtration device has an inlet and an outlet, the inlet of the filtration device coupled to the outlet port of the mixing container. The filtration device includes a filter membrane with a nominal pore size in a range of approximately 0.1 ?m to approximately 0.5 ?m. The product bag has an inlet port coupled to the outlet of the filtration device, and has a bladder defining an empty sterile chamber for receiving sterilized and reconstituted product resulting from mixing a diluent with a product concentrate in the mixing chamber to obtain a mixture then introduced through the filtration device to obtain the reconstituted and sterilized product.

Abstract: A system for reconstituting and sterilizing a concentrate includes a mixing container, a filtration device, and a product bag. The a mixing container has an inlet port and outlet port in fluid communication with a mixing chamber disposed between the inlet port and the outlet port. The mixing chamber is adapted to contain a product concentrate. The filtration device has an inlet and an outlet, the inlet of the filtration device coupled to the outlet port of the mixing container. The filtration device includes a filter membrane with a nominal pore size in a range of approximately 0.1 ?m to approximately 0.5 ?m. The product bag has an inlet port coupled to the outlet of the filtration device, and has a bladder defining an empty sterile chamber for receiving sterilized and reconstituted product resulting from mixing a diluent with a product concentrate in the mixing chamber to obtain a mixture then introduced through the filtration device to obtain the reconstituted and sterilized product.

Abstract: A renal failure blood therapy system includes a renal failure blood therapy machine, concentration levels for each of a plurality of solutes removed from a patient's blood at each of the multiple times, a display device configured to display for selection at least one removed blood solute from the plurality of removed blood solutes, and a device programmed to (i) estimate at least one renal failure blood therapy patient parameter using the determined concentration levels for the at least one selected removed blood solute, (ii) determine a plurality of acceptable renal failure blood therapy treatments that meet a predetermined removed blood solute clearance for the at least one selected removed blood solute using the at least one renal failure blood therapy patient parameter, and (iii) enable selection of at least one of the plurality of acceptable renal failure blood therapy treatments for operation at the renal failure blood therapy machine.