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.

Abstract: A system for performing a peritoneal dialysis therapy includes at least one dialysis fluid pump, and a logic implementer operable with the at least one dialysis fluid pump to perform a plurality of peritoneal dialysis cycles for a patient. The logic implementer transmits an amount of dialysis fluid provided during the plurality of peritoneal dialysis cycles. A server receives the amount of dialysis fluid provided during the plurality of peritoneal dialysis cycles and determines an amount of ultrafiltration (“UF”) removed from the patient based on the amount of dialysis fluid provided by the at least one dialysis fluid pump. The server also updates 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 generates an alert if the UF trend changes by more than a preset percentage.

Abstract: Dialysis is enhanced by using nanoclay sorbents to better absorb body wastes in a flow-through system. The nanoclay sorbents, using montmorillonite, bentonite, and other clays, absorb significantly more ammonium, phosphate, and creatinine, and the like, than conventional sorbents. The montmorillonite, the bentonite, and the other clays may be used in wearable systems, in which a dialysis fluid is circulated through a filter with the nanoclay sorbents. Waste products are absorbed by the montmorillonite, the bentonite, and the other clays and the dialysis fluid is recycled to a patient's peritoneum. Using an ion-exchange capability of the montmorillonite, the bentonite, and the other clays, waste ions in the dialysis fluid are replaced with desirable ions, such as calcium, magnesium, and bicarbonate. The nanoclay sorbents are also useful for refreshing a dialysis fluid used in hemodialysis and thus reducing a quantity of the dialysis fluid needed for the hemodialysis.

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 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 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: Dialysis is enhanced by using nanoclay sorbents to better absorb body wastes in a flow-through system. The nanoclay sorbents, using montmorillonite, bentonite, and other clays, absorb significantly more ammonium, phosphate, and creatinine, and the like, than conventional sorbents. The montmorillonite, the bentonite, and the other clays may be used in wearable systems, in which a dialysis fluid is circulated through a filter with the nanoclay sorbents. Waste products are absorbed by the montmorillonite, the bentonite, and the other clays and the dialysis fluid is recycled to a patient's peritoneum. Using an ion-exchange capability of the montmorillonite, the bentonite, and the other clays, waste ions in the dialysis fluid are replaced with desirable ions, such as calcium, magnesium, and bicarbonate. The nanoclay sorbents are also useful for refreshing a dialysis fluid used in hemodialysis and thus reducing a quantity of the dialysis fluid needed for the hemodialysis.

Abstract: A handheld personal communication apparatus for dialysis includes a reader to (i) 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, and/or (ii) receive a patient weight signal from a weight scale; a processor using at least one of the dialysis fluid type, dialysis fluid volume, or patient weight 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 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 method of providing filled product bags of sterile and particulate-free fluid includes securing a product bag to one of a plurality of movable cradles, wherein the product bag has a bladder, a stem fluidly connected to an opening of the bladder, and a filter disposed in-line with the stem. After securing the bag, an inlet of the stem is connected to an outlet of a nozzle assembly and at least partially filling the product bag with a fluid through a nozzle of the nozzle assembly to create a filled product bag, wherein filling the product bag includes passing the fluid through the filter and into the bladder. After filling, the stem of the filled product bag is sealed at a location below the filter. The stem is cut at a location above the seal and below the filter.

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 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 system for performing a peritoneal dialysis therapy includes at least one dialysis fluid pump, and a logic implementer operable with the at least one dialysis fluid pump to perform a plurality of peritoneal dialysis cycles for a patient. The logic implementer transmits an amount of dialysis fluid provided during the plurality of peritoneal dialysis cycles. A server receives the amount of dialysis fluid provided during the plurality of peritoneal dialysis cycles and determines an amount of ultrafiltration (“UF”) removed from the patient based on the amount of dialysis fluid provided by the at least one dialysis fluid pump. The server also updates 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 generates an alert if the UF trend changes by more than a preset percentage.

Abstract: A sterile product bag includes a bladder, a stem, a filter, and a vial adaptor. The bladder has a perimeter seal and defining a sterile chamber. The stem extends through the perimeter seal and has an inlet end outside of the perimeter seal and an outlet end in fluid communication with the chamber. The filter is disposed in line with the stem and has a filter membrane with a nominal pore size in a range of approximately 0.1 ?m to approximately 0.5 ?m. The filter membrane is shaped as a hollow fiber with a wall and pores residing in the wall of the fiber. The vial adaptor includes a sterile hollow cannula, a sheath, and a peelable closure. The cannula is in fluid communication with the chamber of the bladder. The sheath is disposed outside of the bladder and connected to the hollow cannula. The sheath includes an interior cavity into which the hollow cannula extends. The peelable closure extends across an opening of the sheath to seal the interior cavity.

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 performing a peritoneal dialysis therapy includes at least one dialysis fluid pump, and a logic implementer operable with the at least one dialysis fluid pump to perform a plurality of peritoneal dialysis cycles, the cycles including a fill phase, a dwell phase and a drain phase, the logic implementer configured to: (i) store a first peritoneal dialysis treatment having a total prescribed fresh dialysis fluid fill volume delivered over a number of cycles; and (ii) convert the first peritoneal dialysis treatment into a second peritoneal dialysis treatment having a different number of cycles and using the same total prescribed fresh dialysis fluid fill volume.

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 medical product includes a bladder, a filtration device, and a sterile product concentrate. The bladder has a perimeter seal and defining a sterile chamber. The filtration device includes a stem and a filter membrane disposed in line with the stem. The stem extends through the perimeter seal and has an inlet end accessible from outside of the perimeter seal and an outlet end in fluid communication with the sterile chamber. The filter membrane can have a nominal pore size in a range of approximately 0.1 ?m to approximately 0.5 ?m, wherein the filter membrane is shaped as a hollow fiber with a wall and pores residing in the wall of the fiber. The sterile product concentrate is disposed in the sterile chamber and adapted to be reconstituted by the introduction of a pharmaceutical fluid into the chamber through the filtration device.

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 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.