Abstract: Manifolds suitable for use in hemodialysis, hemofiltration, hemodiafiltration, and peritoneal dialysis are provided. One or more of the manifolds can include a manifold body and an external tube. The manifold body can include at least one conduit including a first conduit and at least one port including a first port in fluid communication with the first conduit. The external tube can be in fluid communication with the first port and can include a main segment, a first branch segment, and a second branch segment containing at least one bacterial filter. The first branch segment and/or second branch segment can include at least one flow restrictor. Dialysis machines, systems, and kits including one or more such manifolds are also provided, as are methods of performing hemodiafiltration using such manifolds.

Abstract: Embodiments of the disclosure provide a method for evaluating dialyzers used in different medical applications (e.g., hemodialysis). Red blood cell volume lost in a dialyzer is monitored by obtaining blood flowrate measurements and hematocrit measurements at input ports and output ports of the dialyzer. The flowrate and hematocrit measurements are used to determine an accumulation of red cell blood volume in the dialyzer. The measurements may be obtained in a lab environment with an in-vitro blood source or may be obtained in a clinical setting with an in-vivo blood source from a patient.

Abstract: A spectroscopic detection system includes a sensor configured to reflect light of a first wavelength associated with a presence of a reference substance on the sensor and configured to reflect light of a second wavelength associated with a presence of a monitored substance on the sensor, wherein the monitored substance flows to the sensor from a circulating fluid. The spectroscopic detection system further includes a detector that has first and second channels for respectively receiving the light of the first and second wavelengths reflected from the sensor and one or more processors in electrical communication with the detector and configured to identify an excess condition of the monitored substance with respect to the circulating fluid based on a ratio of a second amount of the light of the second wavelength received at the detector to a first amount of the light of the first wavelength received at the detector.

Abstract: The application is directed to an extracorporeal blood processing system capable of using dialysate to prime the system. A plastic molded compact manifold supports molded blood and dialysate fluidic pathways along with relevant sensors, valves and pumps. The compact manifold is also disposable in one embodiment and can be detachably installed in the dialysis machine. A two-way valve in the manifold is used to direct the dialysate flow through the blood circuit to prime the circuit for use in treatment.

Abstract: The present invention is directed toward a dialysis unit that is modular and portable, with improved functionality. In one embodiment, the dialysis system comprises a top unit that is detachably affixed to a base that comprises a reservoir for fluid storage. Among numerous other features, the portable, modular dialysis system of the present invention has improved power door locking, zoned leak detection, fluid handling, and mechanical design features that enable improved modularity.

Abstract: Constraining adaptive optimizations of a state of an operation module of a medical device includes determining if a new state has at least one operational parameter that is outside a constraint that has been provided to the medical device in a non-repudiable manner, accepting the new state if no operational parameters are outside any of the constraints, and reverting the medical device to a previous valid state if at least one operational parameter is outside at least one of the constraints. The adaptive optimizations may be provided using artificial intelligence along with relevant inputs thereto. The medical device may be a dialysis system. Constraint data may be provided to the medical device along with a one-way hash value of the constraint data using, for example, a SHA 256 hash. The one-way hash value may be digitally signed using a private key that is part of a public/private key pair.

Abstract: An extracorporeal blood processing system comprises a plastic molded compact manifold that supports a plurality of molded blood and dialysate fluidic pathways along with a plurality of relevant sensors, valves and pumps. A disposable dialyzer is connected to the molded manifold to complete the blood circuit of the system. The compact manifold is also disposable in one embodiment and can be detachably installed in the dialysis machine.

Abstract: A method comprising: establishing a wireless connection between a first medical device and a second medical device, comprising: receiving, by the first medical device, via a short-range wireless technology protocol, connection information related to the second medical device; and establishing, by the first medical device, a wireless connection with the second medical device based on the connection information.

Abstract: An electrical sensor for sensing electromagnetic properties of process fluids in a dialysis machine or a similar medical device can include a probe for interfacing with the fluids that is made from electronic fabric materials. The electronic fabric probe can include one or more conductors embedded in a non-conductive fabric layer. The electronic fabric probe is accommodated an enclosure which establishes a flow path with respect to the probe to establish fluid contact between the process fluids and the conductors. The conductors can apply or sense current and/or voltage with respect to the fluid. A portion of the electronic fabric probe can be disposed externally of the enclosure to provide electronic communication externally of the enclosure.

Abstract: Constraining adaptive optimizations of a state of an operation module of a medical device includes determining if a new state has at least one operational parameter that is outside a constraint that has been provided to the medical device in a non-repudiable manner, accepting the new state if no operational parameters are outside any of the constraints, and reverting the medical device to a previous valid state if at least one operational parameter is outside at least one of the constraints. The adaptive optimizations may be provided using artificial intelligence along with relevant inputs thereto. The medical device may be a dialysis system. Constraint data may be provided to the medical device along with a one-way hash value of the constraint data using, for example, a SHA 256 hash. The one-way hash value may be digitally signed using a private key that is part of a public/private key pair.

Abstract: A dialysis machine (e.g., a peritoneal dialysis machine) may include a housing. The machine may further include a leak detector disposed in the housing, the leak detector being an electrical circuit. In response to fluid contacting the leak detector, a leak in the dialysis machine is detectable. The machine is configured to send a signal based on a short of the electrical circuit from fluid contact with the leak detector to indicate a leak condition.

Abstract: A peritoneal dialysis system includes a base peritoneal dialysis system and a peritoneal dialysis fluid exchange system that operates independently of the base system. The base system includes a first cassette including a first patient line configured to be connected to a patient, and a PD cycler. The PD cycler receives the first cassette, and includes a pump that cooperates with the first cassette to deliver dialysate to and drain dialysate from a peritoneal cavity of the patient via the first patient line. The peritoneal dialysis fluid exchange system includes a second cassette including a second patient line configured to be connected to the patient and a fluid exchange device that receives the second cassette. The fluid exchange device includes a data exchange interface operable to transfer patient treatment data from the peritoneal dialysis fluid exchange system to the base peritoneal dialysis system.

Abstract: An electrical sensor for sensing electromagnetic properties of process fluids in a dialysis machine or a similar medical device can include a probe for interfacing with the fluids that is made from electronic fabric materials. The electronic fabric probe can include one or more conductors embedded in a non-conductive fabric layer. The electronic fabric probe is accommodated an enclosure which establishes a flow path with respect to the probe to establish fluid contact between the process fluids and the conductors. The conductors can apply or sense current and/or voltage with respect to the fluid. A portion of the electronic fabric probe can be disposed externally of the enclosure to provide electronic communication externally of the enclosure.

Abstract: Systems and sensor clip assemblies for optically monitoring blood flowing through a blood chamber are provided. A sensor clip assembly includes emitters and photodetectors positioned on opposing arms, a signal conditioning circuit for conditioning raw analog signals generated by the photodetectors while the sensor clip assembly is fastened to a blood chamber, and an analog-to-digital converter for converting the conditioned analog signals to raw digital data. The sensor clip assembly may include a microcontroller for calculating parameters of blood flowing through the blood chamber such as hematocrit, oxygen saturation, and change in blood volume from the raw digital data. The sensor clip assembly is in communication with a networked computer, and the networked computer is in communication with a remote computer configured to provide a user interface for monitoring and/or controlling the sensor clip assembly.

Abstract: The present specification discloses a dialysis system having a reservoir module with a reservoir housing defining an internal space, a surface located within the internal space for supporting a container that contains dialysate, and a conductivity sensor located within the internal space, where the conductivity sensor has a coil, a capacitor in electrical communication with the coil, and an energy source in electrical communication with the circuit.

Abstract: Devices and methods for assembling a luer lock fitting (e.g., fitting for use in a hemodialysis and/or a peritoneal dialysis machine) may include a luer lock tool comprising a tool base including a grip portion adjacent a tool portion, the grip portion having an outer diameter and an internal cavity. The tool portion may have an internal cavity and may be configured to selectively receive and retain a male luer lock fitting at a first end of the cavity. A tool cap may have an outer diameter and an internal cavity. The tool cap may include a recessed portion at an end configured to selectively receive and retain a female luer lock fitting. The tool cap internal cavity may be configured to receive at least a portion of the tool portion of the tool base.

Abstract: A medical treatment system comprising a housing; a recess defined by the housing; and a keyboard connected to the housing by a mechanism configured to permit the keyboard to move between: a deployed position in which the keyboard is disposed outside of the recess at an angle of 10° to 80° relative to a front surface of the housing; and a stored position in which the keyboard is at least partially disposed in the recess and keys of the keyboard are exposed for use by a user.

Abstract: A dialysis system (e.g., a hemodialysis (HD) system) can be designed to operate in alternative environments, such as disaster relief settings or underdeveloped regions. The dialysis system can include a solar panel for generating electricity to power the dialysis machine and an atmospheric water generator for extracting water from ambient air. The extracted water can be used to generate dialysate and saline on-site. One or more of the components of the dialysis machine can be discrete components that are configured to facilitate fast shipping and simple on-site assembly (e.g., at a remote location). In some implementations, the discrete components may be configured to be attached to an existing dialysis system (e.g., a dialysis system designed for operation in a traditional environment) to permit the dialysis system to operate in an alternative environment.

Abstract: A medical treatment machine, such as a dialysis machine (e.g., a home dialysis machine, such as a home hemodialysis machine or a home peritoneal dialysis machine) can receive a digital prescription file that defines parameters of a medical treatment to be administered to a patient. The digital prescription file can be prepared and delivered in such a way that the medical treatment machine can confirm that the issuer (e.g., provider) of the digital prescription file is an authorized issuer without having any a priori knowledge of the particular issuer. The digital prescription file can be delivered irrespective of the inherent security (or lack thereof) of the transmission medium in a tamper-evident format using minimal resources necessary to verify the validity of the digital prescription file and its issuer. The digital prescription file may be delivered to the dialysis machine using a network cloud-based connected health system.