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 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 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 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 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: Methods and apparatuses for regenerating used dialysis fluid are described herein. In an embodiment, a regenerative dialysis fluid system includes a dialysis unit configured to generate used dialysis fluid including urea, a urea separation unit configured to separate at least a portion of the urea from the used dialysis fluid into a secondary fluid, and a urea removal unit configured to remove at least a portion of the urea from the secondary fluid and return the secondary fluid to the urea separation unit. In an embodiment, the urea separation unit includes a membrane separating a dialysis fluid chamber from a urea chamber, the membrane including at least one of: (i) a positive charge to prevent positive ions from transporting across the membrane; and (ii) a negative charge to prevent negative ions from transporting across the membrane.

Abstract: An infusion device for dispensing fluid at a predetermined flow rate includes an elastic bladder, a pressure regulator, and a flow restrictor. The elastic bladder includes a bladder volume portion and a bladder outlet, and the elastic bladder stores fluid in the bladder volume portion and dispenses fluid through the outlet at a bladder pressure. The pressure regulator is in fluid communication with the outlet of the elastic bladder. The pressure regulator includes a fluid inlet and a fluid outlet. The fluid inlet is coupled to the bladder outlet to receive fluid from the bladder. The flow restrictor is in fluid communication with the fluid outlet. The flow restrictor and the pressure regulator cooperate to discharge fluid from the flow restrictor at a predetermined flow rate.

Abstract: The present disclosure provides devices and methods of using same for cleansing a solution (e.g., a salt or used dialysis solution) of urea via electrooxidation, and more specifically to cleansing a renal therapy solution/dialysis solution of urea via electrooxidation so that the renal therapy solution/dialysis solution can be used or reused for treatment of a patient. In an embodiment, a device for the removal of urea from a fluid having urea to produce a cleansed fluid includes a urea decomposition unit and an electrodialysis unit.

Abstract: A method of cleaning used dialysis fluid having urea to produce a cleaned dialysis fluid, the method including passing the used dialysis fluid having urea through a combination electrodialysis and urea oxidation cell, the cell including (i) a first set of electrodes for separation of the used dialysis fluid having urea into an acid stream and a basic stream, wherein the first set of electrodes includes an anode and a cathode; (ii) one or more second set of electrodes positioned to contact the basic stream with an electrocatalytic surface for decomposition of urea via electrooxidation, wherein the one or more second set of electrodes includes an anode and a cathode; and (iii) at least one power source to provide the first and second sets of electrodes with an electrical charge to activate the electrocatalytic surface.

Abstract: Methods and apparatuses for regenerating used dialysis fluid are described herein. In an embodiment, a regenerative dialysis fluid system includes a dialysis unit configured to generate used dialysis fluid including urea, a urea separation unit configured to separate at least a portion of the urea from the used dialysis fluid into a secondary fluid, and a urea removal unit configured to remove at least a portion of the urea from the secondary fluid and return the secondary fluid to the urea separation unit. In an embodiment, the urea separation unit includes a membrane separating a dialysis fluid chamber from a urea chamber, the membrane including at least one of: (i) a positive charge to prevent positive ions from transporting across the membrane; and (ii) a negative charge to prevent negative ions from transporting across the membrane.

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: The present disclosure provides devices and methods of using same for cleansing a solution (e.g., a salt solution) of urea via electrooxidation, and more specifically to cleansing a renal therapy solution/dialysis solution of urea via electrooxidation so that the renal therapy solution/dialysis solution can be used or reused for treatment of a patient. In an embodiment, a device for the removal of urea from a fluid having urea to produce a cleansed fluid includes a combination electrodialysis and urea oxidation cell.

Abstract: The present disclosure provides devices and methods of using same for cleansing a solution (e.g., a salt solution) of urea via electrooxidation, and more specifically to cleansing a renal therapy solution/dialysis solution of urea via electrooxidation so that the renal therapy solution/dialysis solution can be used or reused for treatment of a patient. In an embodiment, a device for the removal of urea from a fluid having urea to produce a cleansed fluid includes a urea decomposition unit and an electrodialysis unit.

Abstract: A container closure is provided for use in dispensing fluids from a container, and includes a base constructed and arranged for being attached to a mouth of the container, a first port disposed on the base and in fluid communication with the mouth, a second port disposed on the base in fluid communication with the mouth, and the first and second ports being visually differentiated from each other.

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 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 dialysis system for determining an amount of total chlorine in a partially purified water sample is disclosed. The system includes a water machine that produces at least partially purified water including an at least partially purified water sample and a dialysis machine that provides a dialysis treatment to a patient. The dialysis machine receives the at least partially purified water from the water machine to prepare dialysis fluid for the dialysis treatment. The system also includes a total chlorine detector configured to receive the at least partially purified water sample, at a first time apply a source voltage to the at least partially purified water sample, and at a second time stop applying the source voltage to the at least partially purified water sample and instead monitor a sensed electrical parameter to determine an amount of total chlorine in the at least partially purified water sample.

Abstract: A system and method for determining a concentration of total chlorine in dialysis water are provided. The system comprises a main unit housing an iodide/water sample chamber and a reducing agent chamber. An electrode pair bridges the two chambers and generates tri-iodide proportional to the amount of total chlorine in the dialysis water. The electrode pair detects the amount of tri-iodide generated in proportion to the amount of active chloride in the dialysis water. The system is suitable for use in connection with, or for incorporation into, a water purification system for generating dialysis fluid, and may include a display that alerts the user to stop or prevent a hemodialysis treatment if the total chlorine level exceeds a predetermined level.

Abstract: A system and method for determining a concentration of total chlorine in dialysis water are provided. The system comprises a main unit housing a KI/water sample chamber and a sodium sulfate chamber. A first electrode pair bridges the two chambers and generates tri-iodide proportional to the amount of total chlorine in the water sample. A second electrode pair in contact with fluid in the KI/water sample detects an amount of tri-iodide generated by the first electrode pair. The system is suitable for use in connection with, or for incorporation into, a water purification system for generating dialysis fluid, and may include a display that alerts the user to stop or prevent a hemodialysis treatment if the total chlorine level exceeds a predetermined level.