Abstract: A sensor assembly measures characteristics of a fluid entering or exiting a patient via a catheter. The sensor assembly includes a flow tube that accepts the fluid at a first end thereof expels the fluid at a second end thereof, a plurality of sensors disposed about the flow tube, the sensors including at least one temperature sensor that measures temperature of the fluid and at least one pressure sensor that measures pressure of the fluid, and a connector that connects the sensor assembly to the catheter. The sensors may also include a clarity sensor, a conductivity sensor, a flow sensor, and/or an air detector. The sensor assembly may also include a wireless communication device that provides wireless communication. The sensor assembly may communicate with a dialysis machine via a network. The dialysis machine may be a peritoneal dialysis machine.

Abstract: A dialysate mixing machine may be configured to make dialysate on demand using, among other things, a plurality of concentrates in solid tablet form. For example, a prescription may be received by the dialysate mixing machine indicating the particular chemical constituents and amounts of each chemical constituent to be included in the dialysate. Based on the prescription, the dialysate mixing machine can determine the number of tablets required for each chemical constituent (and, e.g., the required amounts of other chemical constituents that are not in tablet form). The tablets are automatically dispensed and mixed with purified water, bicarbonate, and sodium chloride in a mixing chamber to produce the dialysate according to the prescription. The dialysate mixing machine may be used with and/or coupled to a dialysis machine (e.g., a hemodialysis (HD) machine designed for home use) to provide the dialysate on demand for a dialysis treatment.

Abstract: In one aspect of the invention, a method of charging a medical device includes receiving radiofrequency signals from a remote machine remote from the medical device via a receiver of the medical device. The method includes converting the radiofrequency signals into electrical energy via a generator of the medical device. The method includes storing the electrical energy in an energy cell of the medical device. The method also includes powering a power consumption component of the medical device by transmitting the energy from the energy cell to the power consumption component.

Abstract: Computer code embedded in an electronic component (e.g., a processor, a sensor, etc.) of a medical device, such as a dialysis machine, can be authenticated by comparing a metadata signature derived from the computer code of the electronic component to a key derived from a pre-authenticated code associated with the electronic component. The metadata signature can be derived by running an error-check/error-correct algorithm (e.g., SHA256) on the computer code of the electronic component. A use of the metadata signature enables detection of any unauthorized changes to the computer code as compared to the pre-authenticated code.

Abstract: The disclosure relates to a dialysis machine that comprises a dialyzer, a fluid source, a first line connected to the fluid source, and a container containing bicarbonate. The container connects to the first line and the fluid flows from the fluid source, through the first line, to the container. The dialysis machine further includes a second line connected to the container, a flow rate sensor connected to at least one of the lines, a pressure sensor configured for detecting fluid pressure of the container, a display, and a data processing apparatus. The data processing apparatus is configured to receive signals from the flow rate sensor and the pressure sensor. The data processing apparatus is configured to calculate a size of the container based on the received signals.

Abstract: The present specification provides a dialysate management system for generating, weighing, and heating a dialysate fluid during a dialysis treatment. The dialysate management system includes a container and base enclosure. A bottom surface of the container rests within the base enclosure, which is configured to weigh the fluid in the container and measure its conductivity. The fluid may be heated using a heater integrated into the base enclosure or positioned in-line with a fluid pathway. The base of the container is preferably sloped and positioned within the internal volume of the container is a disposable prescription bag having a predefined quantity of prescription compositions that dissolve when water is poured into the container.

Abstract: A method is disclosed for forming a microporous membrane that incorporates an additive having low water solubility at the membrane's active surface from a precipitation fluid. The incorporated additive at the membrane's active surface can improve one or more of the membrane's hydrophilicity, wettability, anti-fouling behavior, blood compatibility, and stability over long periods of use or repetitive use. The microporous membrane with this modified active surface can be a hollow fiber, flat sheet, or other self-supporting shape. The microporous membranes can be used for membrane filtering or a solute and/or solvent exchange process, which involve contacting aqueous-based fluid or blood with the microporous membrane, such processes for dialysis, blood oxygenation, or blood separation filtering, or other processes.

Abstract: In one aspect, a dialysis fluid cassette includes an inlet fluid line, multiple outlet fluid lines, and a valve including an actuation feature by which the valve can be rotated to fluidly communicate the inlet fluid line with a selected fluid line of the multiple outlet fluid lines.

Abstract: Embodiments of the disclosure provide a system and method for detection of a transient air bubble in an arterial blood flow path during dialysis (e.g., hemodialysis). The system uses measurements from an optical sensor to remove one or more effects of common factors affecting the absorbance of the light incident on the arterial tubing. These factors include color of medium within the arterial tubing, tubing color, angle of illumination, and temperature of the optical detector. A variance of the measurements from the optical sensor are used to determine whether an air bubble is present.

Abstract: A fluid conduit includes a first portion having a first porosity, a second portion disposed immediately adjacent to the first portion, the second portion having a second porosity that is greater than the first porosity, and a third portion of the fluid conduit disposed immediately adjacent to the second portion, the third portion having a third porosity that is less than the second porosity. Each of the first portion, the second portion, and the third portion may be integrally formed as a single, continuous piece defining the fluid conduit.

Abstract: The specification discloses a portable dialysis machine having a detachable controller unit and base unit. The controller unit includes a door having an interior face, a housing with a panel, where the housing and panel define a recessed region configured to receive the interior face of the door, and a manifold receiver fixedly attached to the panel. The base unit has a planar surface for receiving a container of fluid, a scale integrated with the planar surface, a heater in thermal communication with the planar surface, and a sodium sensor in electromagnetic communication with the planar surface. Embodiments of the disclosed portable dialysis system have improved structural and functional features, including improved modularity, ease of use, and safety features.

Abstract: A dialysis machine (e.g., a peritoneal dialysis (PD) machine) can include a pressure sensor mounted at a proximal end of a patient line made of a distensible material that provides PD solution to a patient through a catheter. During treatment, an occlusion can occur at different locations in the patient line and/or the catheter. When an incremental volume of additional solution is provided to the patient line while the occlusion is present, a change in pressure results. The change in pressure depends on dimensions and a distensibility of a non-occluded portion of the patient line. If the change in pressure, the incremental volume, properties related to the distensibility of the patient line, and some of the dimensions of the patient line are known, a location of the occlusion can be inferred. An occlusion type can be inferred based on the inferred location.

Abstract: A method for treating dialysate solutions used in dialysis wherein dialysate is treated in an early part of a dialysis treatment session by external infusion of bicarbonate solution into the dialysate circuit to eliminate the need for bicarbonate requirements in concentrates used for preparation of precursor dialysate (priming) solutions and/or for a solid bicarbonate layer in a sorbent cartridge. Dialysate is treated in a latter part of a dialysis treatment session by introduction of sterile dilution water to reduce sodium concentration in the dialysate. The method provides a more efficient and reduced use of dialysate fluids, electrolytes, sorbent cartridge materials, equipment scale, or any combinations of these, while maintaining purity standards and applicable physiological ranges for bicarbonate, sodium, and other dialysate solution components over the course of a dialysis treatment session.

Abstract: The disclosed arterial chambers for hemodialysis may include a cap with a blood inlet port for conveying an intended patient's blood into the arterial chamber, an auxiliary port configured to provide fluid access to the arterial chamber, and a needleless access port configured to couple to a needleless syringe. The needleless access port may be configured for administering a substance to an interior of the arterial chamber from the needleless syringe and/or for withdrawing blood from the interior of the arterial chamber into the needleless syringe. Various tubing sets, hemodialysis systems, and other components, systems, and methods are also disclosed.

Abstract: The disclosed packaging containers may include a body including a sidewall and at least one top flap for at least partially covering an opening of the body when assembled and perforations in the sidewall of the body. The perforations may include a lower perforation having a first end portion and a second end portion; a first side perforation extending upward toward the top flap from the first end portion of the lower perforation; and a second side perforation extending upward from the second end portion of the lower perforation, wherein the first side perforation and the second side perforation converge toward each other as they extend upward from the lower perforation. Various other packaging containers, systems, and methods are also disclosed.

Abstract: The disclosed flexible medical containers may include a substantially transparent bag including a cavity sized and configured to contain a medical substance, at least one port in fluid communication with the cavity, and at least one hanger hole sized and shaped for suspending the flexible medical container from a hanger. The hanger hole may be at least partially surrounded by a colored material to provide visible contrast between the colored material and the hanger hole. In some disclosed examples, the flexible medical containers may include one or more digit holes adjacent to the hanger hole to facilitate lifting and holding the flexible medical containers. Various other flexible medical containers, systems, and methods are also disclosed.

Abstract: Methods to treat anemia are provided whereby an erythropoietin stimulating agent (ESA) and an iron supplement are administered by a wearable device, based on patient parameters sensed by the wearable device. The method can involve monitoring patient parameters and dosing an ESA and an iron supplement in real-time, via the wearable device.

Abstract: The present invention relates to an injection port for connecting with a container, such as a medical fluid container. The injection port includes a barrel, a septum, and a cap, which are sequentially formed via a three-shot injection molding process. The present invention further relates to an assembly that includes the injection port connected to a container. Further, the present invention relates to a method of making the injection port utilizing a three-shot injection molding process.

Abstract: Exemplary systems and methods for estimating progression of chronic kidney disease in a patient and applying clinical interventions may include determining historic values of at least one patient parameter that varies as a function of the progression of the chronic kidney disease over time, and computationally estimating a trend corresponding to the historic values. Based on the trend, at least one marker may be automatically provided that identifies a clinical intervention and a time in the future when the clinical intervention is expected to be needed. Based on the at least one marker, clinical preparations may be executed at a time prior to the administration of the intervention in order to improve at least one of a) timeliness of the execution of the intervention and b) effectiveness of the intervention.

Abstract: The present invention relates to the use of additives in processes to form polymeric fibers. These fibers can be formed into membranes with improved middle and/or higher molecular weight solute removal.