PUMP DEVICE, PERITONEAL DIALYSIS DEVICE, SYSTEM AND METHOD

Abstract

An embodiment relates to a peritoneal dialysis system comprising a controller, a durable unit, and a disposable unit comprising a housing and removably coupleable to the durable unit, the disposable unit configured to receive a tube having a channel, the tube being compressible by a wheel of a pump to cause fluid flow in the channel. The disposable unit and / or the tube comprises at least one flow breaker configured to interrupt a flow of fluid through the tube. The durable unit further comprises a slider platform for receiving at least one biasing element and at least one actuator controllable by the controller. The slider platform can be actuated to controllably slide from a retracted position to an advanced position for changing a flow breaker configuration for the at least one flow breaker.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to Israeli Patent Application No. 290396, entitled "PUMP DEVICE, AND PERITONEAL DIALYSIS DEVICE, SYSTEM AND METHOD," filed February 6, 2022, and Israeli Patent Application No. 298182, entitled "PUMP DEVICE, AND PERITONEAL DIALYSIS DEVICE, SYSTEM AND METHOD," filed November 13, 2022. The contents of the above applications are incorporated by reference in their entirety as if fully set forth herein.

[0002] The present invention, in some embodiments thereof, relates to systems, devices and methods for dialysis treatment. [Background technology]

[0003] Peritoneal dialysis is a life-saving procedure for removing waste products and excess water from the blood. It is primarily used to maintain the health of patients experiencing kidney failure. Summary of the Invention

[0004] Peritoneal dialysis uses the peritoneal membrane as a biological semipermeable membrane to remove waste products and excess water from the body's blood. The waste products and excess water move from the blood, across the peritoneal membrane, and into a special dialysis solution (called dialysate) in the peritoneal cavity (more specifically, the peritoneal cavity). The waste products removed include uremic waste products, excess water, and excess minerals.

[0005] The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.

[0006] For simplicity and clarity of illustration, elements shown in the figures are not necessarily drawn to scale. For example, dimensions of some elements may be exaggerated relative to other elements for clarity of presentation. Additionally, reference numerals may be repeated among the figures to indicate corresponding or similar elements. Previously presented elements shall be implicitly included without necessarily further reference to the figures or descriptions in which they are shown. The figures are listed below. [Brief description of the drawings]

[0007] [Figure 1] FIG. 1 is a schematic block diagram of a dialysis system, according to some embodiments. [Diagram 2] FIG. 1 is a schematic diagram of a dialysis system, according to some embodiments. [Diagram 3] FIG. 1 is a schematic diagram of a dialysis machine fluidly coupled with a dialysis patient, a fresh dialysate bag, and a spent dialysate bag, according to some embodiments. [Figure 4] FIG. 1 is a schematic piping and instrumentation diagram of a dialysis system according to some embodiments. [Figure 5A] FIG. 1 is a schematic diagram of a dialysis machine with the lid open, according to some embodiments. [Figure 5B] FIG. 1 is a schematic diagram of a dialysis machine with the lid closed, according to some embodiments. [Figure 5C] FIG. 1 is a schematic bottom view of a disposable cartridge of a dialysis machine, according to some embodiments. [Figure 5D] FIG. 1 is a schematic side view of a disposable cartridge of a dialysis machine, according to some embodiments. [Figure 5E] 1 is a schematic exploded view of a disposable cartridge according to some embodiments. [Figure 5F] FIG. 1 is a schematic diagram of a portion of a disposable cartridge and a portion of a pump that engages with tubing of a dialysis system, according to some embodiments. [Figure 5G] FIG. 1 is a schematic diagram of a portion of a disposable cartridge and a portion of a pump of a dialysis system according to some embodiments. [Figure 5H] FIG. 2 is a schematic diagram of the top of a disposable cartridge according to some embodiments. [Figure 5I] 1 is a schematic cross-sectional view of a disposable cartridge according to some embodiments. [Figure 6A] FIG. 1 is a schematic diagram of a dialysis machine with the lid open, according to some embodiments. [Figure 6B] FIG. 1 is a schematic diagram of a dialysis machine with the lid closed, according to some embodiments. [Figure 6C] FIG. 1 is a schematic diagram of a dialysis machine, according to some other embodiments. [Figure 7A] FIG. 2 is a schematic exploded view of a pump rotor according to some embodiments. [Figure 7] 7B-7E are different schematic views of a pump rotor, according to some embodiments. [Figure 8A] FIG. 1 is a schematic diagram of a flow breaker in operative engagement with a tube in a closed configuration according to some embodiments. [Figure 8B] 8B is a schematic diagram of the flow breaker of FIG. 8A in a closed configuration according to some embodiments. [Figure 8C] FIG. 2 is a schematic diagram of a flow breaker in an open position according to some embodiments. [Figure 8D] FIG. 13 is a schematic diagram of an actuator in a retracted position that places a disposable and a flow breaker in a closed configuration, according to some embodiments. [Figure 8E] FIG. 13 is a schematic diagram of an actuator in an advanced position with a disposable and a flow breaker in an open configuration, according to some embodiments. [Figure 8F] FIG. 13 is a schematic diagram of a flow breaker in a blocking configuration according to some other embodiments. [Figure 8G] FIG. 8I is a schematic diagram of the flow breaker of FIG. 8I in an open or unblocked configuration, according to some other embodiments. [Figure 8H] FIG. 8I is a schematic diagram of the flow breaker of FIG. 8I in an open or unblocked configuration, according to some other embodiments. [Figure 8I] 13 is a schematic diagram of a flow breaker in a blocking configuration according to some other alternative embodiments. [Figure 8J] FIG. 8I is a schematic diagram of the flow breaker of FIG. 8I in an open or unblocked configuration, according to some other embodiments. [Figure 8K] FIG. 8I is a schematic diagram of the flow breaker of FIG. 8I in an open or unblocked configuration, according to some other embodiments. [Figure 8L] FIG. 8I is a schematic partial view of a disposable cartridge and flow breaker of FIG. 8I in a closed configuration according to an alternative embodiment. [Figure 8M] FIG. 8I is a schematic partial view of a disposable cartridge and flow breaker of FIG. 8I in an open configuration according to an alternative embodiment. [Figure 9] 9A-9C are schematic diagrams of different assemblies of a connection between a patient catheter and an external catheter, according to some embodiments. [Figure 10] FIG. 1 is a schematic diagram of a membrane puncture device, according to some embodiments. [Figure 11] 11A-11C are schematic diagrams of different assemblies of the connection between the patient catheter and the external catheter according to some other embodiments. [Figure 12] 12A and 12B are schematic diagrams of various pump rotor elements engaging with a pump tube, according to some embodiments. [Figure 13] 13A and 13B are schematic flow charts of a method for performing peritoneal dialysis, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] The principles and operation of an improved peritoneal dialysis device according to the present invention may be better understood with reference to the drawings and accompanying descriptions.

[0009] Referring now to the drawings, FIG. 1 illustrates a system or device for peritoneal dialysis therapy, according to some embodiments.

[0010] According to some embodiments, the dialysis system 100 comprises a dialysis machine 102, a dialysate bag 124 or a drain bag, and a patient catheter connectable to a patient 130. In some embodiments, the dialysis machine 102 is connectable to the dialysate bag 124 and / or the drain bag, and optionally forms a disinfectant flow path between the bag and the patient 130 by release of a disinfectant material stored in the tubing.

[0011] According to some embodiments, the dialysis machine 102 includes a controller 104 and a fluid handling module 112 that includes a pump. In some embodiments, the controller 104 controls the operation of the fluid handling module, for example, when the fluid handling module is activated to infuse dialysate into the peritoneal cavity or when the fluid handling module is activated to drain the peritoneal cavity.

[0012] In some embodiments, the controller 104 controls the connection of the dialysate bag 124 and / or the drain bag to the dialysis machine 102. Additionally, in some examples, the controller 104 controls the connection of a patient catheter to the dialysis machine 102.

[0013] According to some embodiments, the controller 104 monitors and controls the automatic connection and disinfection of the different components connected to the fluid path.

[0014] In some embodiments, the controller transmits an indication (e.g., a human detectable indication) when a component is connected to the flow path and / or when the flow path is disinfected. Alternatively or additionally, the controller stores the indication in memory.

[0015] According to some embodiments, the controller 104 monitors the flow in the flow path by means of different sensors (e.g., fluid dynamics sensor 116) of the dialysis machine 102. In some embodiments, the fluid dynamics sensor comprises, for example, at least one volume sensor 140 for monitoring the volume of fluid passing through the flow path. Furthermore, the fluid dynamics sensor comprises, for example, at least one temperature control sensor 142 for monitoring and controlling the temperature of the fluid passing through the flow path.

[0016] According to some embodiments, the dialysis machine 102 includes at least one clinical sensor 114 for sensing, for example, changes in clinical parameters. In some embodiments, the at least one clinical sensor senses the chemical and / or biological content of the discharged dialysate, for example using a creatinine sensor 136, and / or a urea sensor 134, and / or a glucose sensor 132. Optionally, one or more biosensors 138 can sense a number of biomolecules for detection of relevant clinical pathogens, such as bacteria and viruses. Optionally, a dextrose / glucose sensor 132 senses dextrose / glucose levels in the infused dialysate.

[0017] According to some embodiments, the dialysis machine 102 includes at least one glucose / dextrose sensor 132 configured to measure glucose / dextrose levels in the drained dialysate. According to some embodiments, the dialysis machine 102 includes at least one sensor for detecting urea levels (e.g., urea sensor 134). In some embodiments, the dialysis machine 102 includes at least one sensor for detecting creatinine levels in the dialysate (e.g., creatinine sensor 136). In some embodiments, the level of creatinine in the drained dialysate, optionally compared to the creatinine level in fresh dialysate, indicates the subject's clinical condition. In some embodiments, the clinical sensor 114 is activated during a treatment session, for example, during infusion and / or drainage of dialysate.

[0018] According to some embodiments, the controller sends instructions and / or alerts to the patient or to a caregiver in the vicinity of the dialysis machine 102. Alternatively or additionally, the controller transmits instructions and alerts to a remote computer (e.g., a physician's computer). In some embodiments, the physician transmits information to the dialysis machine 102, for example, to modify at least one treatment parameter or to select a different treatment plan.

[0019] According to some embodiments, the dialysis machine 102 sends time reminders and / or instructions to the patient to perform a treatment step. In some embodiments, a user of the machine (e.g., the patient or caregiver) provides user input through a user interface, which optionally includes at least one button (e.g., an activation or end treatment button).

[0020] In some embodiments, the inputs received from the user and additional user data are stored in the dialysis machine 102. In some embodiments, the stored user data is transmitted to a physician, for example, to enable remote monitoring of the user status throughout the treatment process. In some examples, an operating log file of the dialysis machine 102 is also stored and optionally used to generate a patient compliance report after a treatment session. According to some embodiments, the dialysis machine 102 further comprises a power supply unit (e.g., a battery, connection to an external power source) 106 for powering various components of the dialysis machine, for example, to enable operation of the controller 104 and / or an electric pump optionally connected to the fluid handling module 112. In some examples, the battery is electrically connected to an electric motor optionally connected to the fluid handling module 112.

[0021] In some embodiments, the dialysis machine 102 includes a charging socket or plug electrically connected to the battery, for example to allow charging of the battery by an external power source. Alternatively, the battery is a replaceable battery. In some embodiments, the control unit controls the operation of the motor according to the power level in the battery.

[0022] In some embodiments, the durability unit comprises an interface coupled to the control circuit and configured to provide at least one human detectable indication (e.g., a warning signal via a light indication and / or an audible indication). The durability unit may comprise a case.

[0023] In some embodiments, when the power level in the battery is below a low threshold, the control circuit signals the interface to generate a warning signal (e.g., a signal indicating to charge the battery or to replace the battery). Alternatively or additionally, when the power level in the battery is below a low threshold, the control circuit stops operation of the motor.

[0024] According to some embodiments, the control circuitry operates the motor in a power saving mode, for example, when the power level in the battery is below a power threshold, which may be a dynamic, adaptive, or predetermined threshold.

[0025] In some embodiments, the control circuitry optionally modifies at least one operating parameter value of the motor (e.g., rotation speed and / or rotation duration) when the motor is operated in the power saving mode. In some embodiments, the control circuitry prevents operation of the motor when the battery power level is below a low threshold.

[0026] According to some embodiments, the power level of the battery when fully charged is sufficient for at least one dialysis treatment session (e.g., two treatment sessions, three treatment sessions, four treatment sessions, or any lesser, intermediate, or greater number of treatment sessions).

[0027] In some embodiments, the treatment session includes at least partially draining dialysate from the peritoneal cavity and at least partially infusing fresh dialysate into the peritoneal cavity. In some examples, the treatment session includes at least partially draining dialysate from the peritoneal cavity, at least partially infusing fresh dialysate into the peritoneal cavity, and a residence time of the dialysate in the peritoneal cavity.

[0028] According to some embodiments, the dialysis machine 102 is connected to a computer server (e.g., server 105). In some embodiments, the server 105 stores treatment protocols and / or machine operation log files. In some embodiments, the controller 104 writes measurements of parameters related to machine operation and / or parameters related to the patient's clinical condition to the server 105. Optionally, a physician communicates with the server 105, for example, to receive machine log files and / or to send treatment instructions or modifications. In some embodiments, the server 105 transmits information to a caregiver (e.g., a nurse) or a warehouse, for example, to supply new dialysate bags.

[0029] According to some embodiments, the dialysis machine 102 communicates with the caregiver 103, for example, to provide the caregiver with clinical information of the patient and / or other information related to the treatment. In some embodiments, the dialysis machine 102 communicates with the physician 109. In some embodiments, the dialysis machine 102 sends an alert to the physician 109 if the actual treatment differs from the predetermined treatment. Alternatively or additionally, the dialysis machine 102 sends an alert to the physician 109 if the desired outcome of the treatment is not reached. In some embodiments, the physician 109 communicates with the patient via the dialysis machine 102, for example, to send instructions and / or to receive further information from the patient.

[0030] According to some embodiments, the dialysis machine 102 is connected to or includes a bag switching device 107. In some embodiments, the dialysis machine 102 (optionally a removable and / or portable device) is attached to the bag switching device 107 during the peritoneal dialysis treatment (e.g., the exchange process). In some embodiments, at least one dialysate bag (e.g., bag 124) is connected to the bag switching device 107. In some embodiments, the bag switching device 107 optionally uses a barcode or a different ID of the bag to verify that the correct bag is connected. In some embodiments, the bag switching device 107 monitors the temperature of the bag and optionally heats the bag using a heating mechanism. In some embodiments, when the exchange session is finished, the removable device is disconnected from the bag switching device 107. According to some embodiments, the device includes a warmer (e.g., warmer 111). Alternatively, the warmer is part of the dialysis machine 100 and / or is part of the bag switching device 107. In some embodiments, the warmer is used to monitor and / or control the temperature of the dialysate bag. In some embodiments, the controller 104 receives a signal from the warmer 111 or from a temperature sensor regarding the temperature of the dialysate. In some embodiments, the controller 104 signals the warmer 111 to heat the dialysate fluid, for example, by heating the dialysate bag. Alternatively, the controller 104 signals the bag switching device 107 to switch the dialysate bag to a bag having the desired dialysate temperature.

[0031] According to some embodiments, the dialysis machine 102 communicates with a handheld device 123 (e.g., a mobile phone). In some embodiments, the dialysis machine 102 transmits alerts and / or instructions and / or information to the handheld device 123. Optionally, the dialysis machine 102 communicates with the handheld device 123 using an application program installed on the machine. In some embodiments, the dialysis machine 102 sends a time alert before the start of treatment, or any time alert, to the handheld device 123. In some embodiments, the handheld device, optionally, uses an application program to at least partially control the operation of the dialysis machine 102. In some embodiments, the dialysis machine 102 receives information from a device connected to the handheld device 123 (e.g., a smart watch or any other wearable sensor).

[0032] Exemplary Device Interactions and Functions

[0033] Reference is now made to FIG. 2, which illustrates the interaction and function of a peritoneal dialysis device according to some embodiments.

[0034] According to some embodiments, the portable peritoneal (PP) dialysis machine 202 comprises a PP dialysis machine, e.g., a durable / reusable unit 204 and a PP disposable unit 206. In some embodiments, the durable unit 204 comprises a case, a power unit (e.g., a battery), a pump motor (e.g., an electric pump motor), and a pump rotor. In some embodiments, the durable unit further comprises at least one sensor, a communication module, and, e.g., a controller (e.g., for controlling the dialysis treatment process and the motor and / or for controlling the operation of the sliding platform). In some embodiments, different controllers or the same controller may be employed to control the sliding platform and / or the dialysis process. In some embodiments, the controller may be provided external to the durable unit.

[0035] According to some embodiments, the disposable unit 206 comprises a carrier, a connection module, and optionally an autoconnect module. In some embodiments, the connection module is also a disinfection module. In some embodiments, the disposable unit 206 comprises at least one sensor (e.g., a clinical sensor for measuring clinical parameters of the treatment and / or of the patient connected to the dialysis machine 202).

[0036] According to some embodiments, a dialysis system 300 including a dialysis machine 202 measures the patient's clinical parameters (e.g., weight 208, blood pressure 210 and / or heart rate 212). In some embodiments, the dialysis system 300 writes the measured parameter values ​​and other information to the system's memory or to a remote memory 214. In some embodiments, the dialysis system 300 reads the treatment plan and treatment parameters from the remote memory 214. Additionally, the device transmits the stored information to a physician 216 and / or to the patient 218. In some embodiments, the physician 216 transmits information (e.g., a proposed treatment protocol or proposed protocol modifications) to the remote memory 214 or directly to the memory of the dialysis system 300.

[0037] Reference is made to FIG. 3, which illustrates a system for delivery of peritoneal dialysis therapy, according to some embodiments.

[0038] According to some embodiments, a portable peritoneal (PP) dialysis system (e.g., dialysis system 300) includes at least one bag (e.g., fresh dialysate bag 370 and drained dialysate bag 380) connected to a connector of the system 300. In some embodiments, a patient catheter tube 352 is connected to a different connector of the system 300.

[0039] Reference is made to FIG. 4, which illustrates a system 400 for monitoring and / or controlling peritoneal dialysis therapy, according to some embodiments.

[0040] According to some embodiments, fresh dialysis solution storage compartment 470 is connected to connector 406 (e.g., a Y-connector) via flow breaker 474. In some embodiments, spent dialysate storage compartment 480 is connected to connector 406 via flow breaker 484. In some embodiments, flow breakers 474, 484 are used to close the flow path between the storage compartments and connector 406. In some embodiments, connector 406 automatically, semi-automatically, or under manual operation, sanitizes the flow path to each of the compartments.

[0041] As described in more detail herein, the flow breaker may be implemented in some embodiments as a valve, a diaphragm, a mechanical energy storage device, or the like.

[0042] According to some embodiments, the connector 406 is positioned at the distal end of the pump tubing associated with the rotor of the peristaltic pump 410. In some embodiments, at least one pressure sensor (e.g., pressure sensor 412) senses the pressure of the fluid in the pump tubing. In some embodiments, at least one flow sensor (e.g., flow sensor 414) senses the flow rate and / or fluid volume in the pump tubing. In some embodiments, at least one peritonitis sensor (e.g., peritonitis sensor 416) senses the formation of peritonitis in the peritoneal cavity, as described above. In some embodiments, the fluid in the pump tubing passes through a heating unit 418. In some embodiments, the heating unit 418 heats the fresh dialysate fluid in the pump tubing to a desired temperature before being infused into the patient's catheter.

[0043] According to some embodiments, a patient catheter 452 connects to the patient's peritoneal cavity 424 via a connector 404. In some embodiments, the connector 404 connects to a proximal end of the pump tubing 402. In some embodiments, the connector 404 automatically or semi-automatically connects the patient catheter to the proximal end of the pump tubing. Additionally or optionally, the connector 404 automatically or semi-automatically causes or facilitates disinfection of the flow path between the patient's catheter and the pump tubing.

[0044] 5A-5E, the disposable unit 500 may be a type of cartridge removably matable with a durable unit 600 having a base portion 602 and a lid 610 for selectively opening and closing the base portion 602.

[0045] In some examples, the base portion 602 may comprise a pump including a pump rotor 700. In some examples, the cartridge 500 may comprise a portion of the pump rotor 700.

[0046] In some embodiments, the disposable unit 500 may be removably coupled to a cartridge storage rack of a durable unit.

[0047] For example, the lid 610 may be configured as or include a cartridge storage rack, and the disposable unit 500 may be removably coupled to (e.g., inserted into) the lid section 610 of the durable unit 600. Closing the lid 610 operably engages the disposable unit 500 with the pump.

[0048] In some other embodiments, the disposable unit 500 may be disposed on or otherwise operably engaged with the pump. For example, the disposable unit 500 may be disposed on or otherwise operably engaged with the pump (e.g., by placing the disposable unit 500 in a retractable drawer (not shown)).

[0049] In some embodiments, the pump tube interacts with or is operatively engaged with the pump, allowing the pump to displace fluid within the tube at a desired rate and in a desired direction, e.g., peristaltically.

[0050] The tubing of the disposable unit is adapted to be (e.g., removably) coupled to a patient catheter on one end and a dialysate bag on the other end. The pump controls the direction and rate of fluid pumped (e.g., peristaltically) through the tubing.

[0051] In some embodiments, the tubing also contains a sterilizing fluid that at least partially or completely sterilizes the catheter (tubing and connectors) and / or the Y-connector and / or the tubing leading to the dialysate bag.

[0052] The disposable unit 500 is adapted to be disposed of after a single use. The cartridge or disposable unit 500 is an example of an implementation of the disposable unit 206 shown in Figures 2 and 3, and the durable unit 600 is an example of an implementation of the durable unit 204 shown in Figures 2 and 3.

[0053] 4, some or all of the components between connector 406 and connector 404 may be implemented within disposable unit 500 and durable unit 600. In a non-limiting example, connectors 404, 406 may be provided within the disposable unit along with tubing 402, while pump 410, sensors 412, 414, 416, and heating element 418 may be located within the durable unit.

[0054] According to some embodiments, the disposable unit 500 comprises a pump tubing 502 with a catheter connector 504 and a dialysate (fresh and / or drained) Y-set tubing connector 506.

[0055] In some embodiments, a flow breaker (eg, a mechanical energy storage element (eg, a spring) or a blocking element) is positioned on tube 502, eg, next to the connector, such as, for example, flow breakers 508A, 508B.

[0056] The flow breaker may comprise, or be operatively coupled to, an actuator and, optionally, a controller configured to set the flow breaker from a closed (or blocking) configuration to an open (or non-blocking) configuration, e.g., as described herein. The flow breaker may be automatically, semi-automatically, or manually actuable.

[0057] In some embodiments, the flow breaker can be biased into the closed (also called shutoff) configuration by, for example, a mechanical storage element (eg, a torsion spring).

[0058] In some embodiments, the flow breaker can be biased into the open (also called non-blocking) configuration by, for example, a mechanical storage element (eg, a torsion spring).

[0059] In some embodiments, the flow breaker is in an idle state for the open and closed configurations.

[0060] 5F and 5G, the disposable unit 500 may include a lower casing or base portion 512 having a lower opening 520 and an upper casing or cover portion 514 having an upper opening or cover opening 522 configured to operably receive a pump rotor 700. When the disposable unit 500 is assembled with the durable unit 600, the wheels or rollers 710 of the pump rotor 700 operably engage the pump tubing 502 to peristaltically induce fluid flow within the tubing 502.

[0061] 5E-5G also show multiple flow breakers (e.g., spring-loaded flow breakers 508A, 508B) in a closed configuration that compresses tube 502. Flow breaker 508B is shown positioned next to catheter connector 504 to prevent fluid from entering or exiting tube 502.

[0062] In some embodiments, when the flow breaker is set in the closed configuration, fluid does not flow into or out of the pump tube. In some embodiments, fluid can only flow into or out of the pump tube when the flow breaker is at least partially open. Each of the flow breakers 508A, 508B has a closed state and an open state. In the closed state, the flow breaker (e.g., a specially designed spring) restricts flow through the tube. In the open state, flow through the tube is not restricted.

[0063] In some examples, the flow breaker may be configured to be "normally open," e.g., such that energy must be applied to the flow breaker to occlude the tube. In some other examples, the flow breaker may be configured to be "normally closed," e.g., such that by default, energy must be applied to hold the breaker in the open configuration.

[0064] In some embodiments, the flow breaker is a spring 800 (see further details below in Figures 8A-8E). The spring has a rest position and a biased position. In the rest position (e.g., as shown in Figures 8A and 8B), the spring restricts flow into the tube (e.g., as shown in Figure 5D). In the biased position (e.g., as shown in Figure 8C), the spring at least partially allows flow through the tube. More precisely, the spring has a biased state (not one biased position, but a range of positions) whereby the spring at least partially allows fluid to flow through the tube. The spring may be partially or fully biased to allow fluid to flow through the tube at different rates.

[0065] In some instances, the rest position is the default position and therefore the closed state is the default state. Thus, in embodiments in which the flow breaker is implemented as a spring 800, the flow breaker is considered normally closed.

[0066] In some examples, the spring is brought from a closed state to an open state by biasing the spring from a rest position / state to a biased position / state. In some embodiments, the open state is achieved by laterally moving a biasing element that compresses two angled sections of the spring together, biasing the spring to an open configuration. Returning the biasing element to its initial position releases the two angled sections, thereby unbiasing the spring and allowing it to return to its rest state, in which the tube is compressed between the two wire spring sections, as shown, for example, diagrammatically in FIG. 8A.

[0067] According to other embodiments, the flow breaker has a closed state and an open state. The closed state is an initial state. The open state is achieved by shutting off the flow breaker. In such embodiments, the flow breaker cannot be returned to the closed state. Furthermore, such a flow breaker has a bistable non-reversible switch that moves the flow breaker from the closed state to the open state and maintains it permanently in the open state.

[0068] In embodiments in which the flow breaker has the primary function of releasing sterile fluid at the appropriate time, it is not necessary for the flow breaker to return to a closed state after the sterile fluid has exited the tubing, whereas in embodiments in which the flow breaker serves one or more additional functions, such as sealing the tubing before changing one of the dialysate bags, being able to return to a closed state may be necessary.

[0069] In some embodiments, at least one flow breaker allows for controlling the flow of fresh dialysate, for example, to the patient's catheter and / or from the patient's catheter to a drain bag.

[0070] According to some embodiments, a portable peritoneal (PP) dialysis system includes a portable peritoneal (PP) dialysis machine including, for example, a durable unit, and a disposable PP dialyzer (e.g., a disposable unit). Optionally, the PP dialysis system includes a PP patient management system.

[0071] In some embodiments, the durability unit includes a motor (optionally an electric motor), and electrical wiring and / or control circuitry for implementing the controller. In some examples, the PP dialysis machine includes a rotor having at least one roller (also called a wheel). The rotor is operably coupled to a drive shaft of the electric motor. At least a portion of the motor, drive shaft, and electrical wiring are part of the pump.

[0072] In some embodiments, the disposable unit comprises a tube having at least one connector. In some embodiments, the disposable unit is molded and sized as a single unit that keeps at least a majority of the disposable elements (e.g., the tube and at least one connector) enclosed in a housing separate from the durable unit. In some embodiments, the separate housing allows for easy assembly ("pick and place") of the disposable unit with the durable unit, for example, while protecting the disposable elements of the system. Additionally, the separate housing allows for the disposable unit to be sold as a ready-to-use product without requiring further assembly of the disposable elements by the user.

[0073] Further reference is made to Figures 5H and 5I. Figure H shows the disposable unit 500 with one of the covers removed to show the tube 502 as it is held in place by the flange or fin 529. Figure 5I is a cross-sectional view of the tube guide 517 with the tube 502, according to some embodiments. In some examples, the tube 502 may terminate in a Y-connector 506 suitable for fluid coupling with the catheter connector 504 and / or the Y-set tubing.

[0074] In some embodiments, the tube guide 517 includes tube retention or retaining elements, such as flanges or fins 529, to hold the tube securely (e.g., by friction) in place within the tube guide 517 to prevent the tube from sliding and / or axial rotation while the pump is running. As a result, pressure sensing remains consistent as it is little or not affected by axial tube movement that may occur without the fins. The tube may be pressed between the straight fins 529 and the angled fins 532 to be fixed in place. This assembly may be performed at the manufacturing site or by the user. The straight fins 529 are approximately perpendicular to the longitudinal axis Q of the tube 502, and the angled fins 532 are angled with respect to the longitudinal axis Q of the tube 502.

[0075] Springs 508A, 508B are shown diagrammatically in a closed configuration in FIG. 5H, applying pressure to tube 502 to block fluid flow.

[0076] Figure 6A shows the PP dialysis machine 102 with the durable unit 600 in an open configuration and the disposable unit 500 partially inserted therein. Figure 6B shows the PP dialysis machine 102 with the durable unit in a closed configuration and an external catheter connector attached to the extended insert tray 620.

[0077] In some embodiments, the disposable unit 500 is placed inside a PP dialysis machine, such as a durable unit 600. In some embodiments, the durable unit 600 includes at least one sensor, and when the disposable unit 500 is positioned inside the durable unit 600, the sensor (not shown) is proximal, and optionally positioned to be aligned with a window 528 in the base 512 through which the tubing 502 can be viewed. In some embodiments, the sensor optionally measures the absorbance of light at a particular wavelength. In some embodiments, the sensor is a spectrophotometer.

[0078] In some embodiments, at least one sensor measures absorption and / or scattering of light passing through the tube in a wavelength range of 500-650 nm, e.g., 500-600 nm, 550-620 nm, 530-630 nm, or any intermediate, smaller, or larger wavelength range. Additionally or alternatively, the sensor or at least one additional sensor measures absorption and / or scattering of light passing through the tube in a wavelength range of 150-350 nm, e.g., 150-250 nm, 200-300 nm, 250-350 nm, or any intermediate, smaller, or larger wavelength range.

[0079] According to some embodiments, at least one sensor or test element is connected to the tubing, for example to measure chemical and / or biological properties of the fluid flowing within the pump tubing.

[0080] Exemplary configurations of disposable units of portable peritoneal dialysis machines

[0081] FIG. 6C is an isometric view of the PP dialysis system with the top cover casing open. According to some embodiments, a disposable unit of the PP dialysis system (e.g., disposable unit 500) comprises a tube 502, at least one connector 506 (e.g., for coupling with a Y-set tube 506), and a catheter connector 504 located at each of the two ends of the tube 502. Optionally, the tube 502 is pre-filled with a sterile fluid. Flow breakers 508A, 508B seal the tube 502 at the catheter end and the dialysate end, respectively. In some embodiments, connecting the external connector 550 to the catheter connector 504 automatically opens the flow breaker 508. In other embodiments, the flow breaker 508 can be manually, semi-automatically, or automatically operated to an open state or position. When opened, a sterile fluid flows into the external catheter connector 550, sterilizing the connector 550 and the catheter tube 551.

[0082] In some embodiments, connection of the Y-set tubing 506 from the dialysate bag to the dialysate tubing of the Y-set tubing 506 automatically opens the flow breaker 508. In other embodiments, the flow breaker may be manually, semi-automatically, or automatically operated to the open state or position. When opened, sterile fluid flows from tubing 502 through the dialysate tubing of the Y-set tubing 506 into the Y-set tubing 506 and tubing 562, sterilizing the connectors and tubing.

[0083] In some embodiments, the Y-connector can be positioned in either orientation. In some embodiments, one or more markers indicate which is drain and which is fresh dialysate fluid.

[0084] In some instances, when the Y-connector splits into two tubes, there are two latches that can compress / decompress the corresponding tubes depending on the stage of the cycle. These latches are referred to herein as flow breakers. In some embodiments, valve breakers are provided to prevent undesired cross-flow during transfer from the drain dialysate tubing portion to the fresh dialysate tubing portion.

[0085] According to some embodiments, the cover portion 514 of the housing is mechanically connected to the base portion 512 of the housing via connecting members (e.g., at least two threaded fasteners, screws, press-fit connectors, latch connectors, etc.). In some embodiments, the threaded fasteners comprise screws and / or bolts. In some embodiments, the two connecting members comprise pins. In some embodiments, each of the at least two connecting members passes through an opening in the cover portion (e.g., opening 524) and enters an opening in the base portion (e.g., base portion opening 526). Optionally, the base portion opening comprises female threads that are complementary to the male threads on the connecting members.

[0086] According to some embodiments, as shown, for example, in Figures 5E-5G, the disposable unit 500 has at least two openings in the housing, i.e., openings 530, 540. In some embodiments, one opening 540 is shaped and sized to connect an external catheter connector 550 to the catheter connector 504, and optionally has a second opening 530 for connecting a Y-set tubing 506. In some embodiments, at least one marking on the exterior surface of the housing indicates, for example, the assembly direction and / or orientation of the disposable unit to the durable unit.

[0087] As shown diagrammatically in this embodiment, the disposable unit 500 is inserted into the durable unit 600 in the movable lid part. After insertion of the disposable unit and the Y-set tubing, the lid is closed and the pump tubing is sandwiched between the wheels and the casing. Even before the start of pumping action, the rim surface of at least one wheel compresses the tubing to at least partially, and possibly completely, restrict flow between the two sides of the compressed area. This compression of the tubing serves to divide the sterile fluid into two compartments: one compartment from the flow breaker adjacent to the catheter connector to the rotor wheel, and a second compartment from the other side of the wheel to the flow breaker adjacent to the Y-set connector. When compressed in this way, fluid can be expelled through either of the flow breakers without emptying the other compartment of sterile fluid.

[0088] In some embodiments, the disposable element is disposed within a molded groove or recess made in an inner surface of the disposable unit housing (e.g., a two-part housing). In some embodiments, the groove or recess is made in an inner surface of at least one part of the two-part housing (e.g., the base portion 512). In some embodiments, the two-part housing comprises a complementary cover portion 514 that is shaped and dimensioned to fit the base portion 512. In some embodiments, the cover portion 514 comprises a groove or recess that fits at least a portion of the three-dimensional shape or contour of the disposable element in the base portion 512.

[0089] According to some embodiments, the base portion 512 and the cover portion 514 are assembled into a housing 515 of the disposable unit 500, for example as shown in Figures 5E and 5F. In some embodiments, the axial length 516 of the housing 515 is at least 10 cm, e.g., 12 cm, 15 cm, 19 cm, 20 cm, 25 cm, or any intermediate, smaller, or greater value. In some embodiments, the width 518 of the housing 515 is at least 1 cm, e.g., 1.5 cm, 2 cm, 2.5 cm, or any intermediate, smaller, or greater value.

[0090] According to some embodiments, the housing is shaped to allow easy assembly to the durable unit and / or easy assembly of the external tube to at least one connector of the disposable unit. In some embodiments, the cover portion 514 may be integrally formed with the lid of the durable unit.

[0091] In some embodiments, the cover portion 514 includes an opening above the rotor (e.g., top opening 522). In some embodiments, the top opening 522 allows for visualization of the rotational direction of the rotor, for example. The cover portion 514 around the top opening 522 can be adapted to hold a curved portion of the pump tubing 502.

[0092] According to some embodiments, as shown, for example, in FIGS. 5E and 5E , the base portion 512 includes a base opening 520 that may be larger than the cover opening 522 and is shaped and dimensioned to allow the rim surface 720 of at least one wheel 710 of the rotor 700 to compress the compressible tube 502.

[0093] When assembled, the disposable unit interfaces with at least one sensor located on an opposing surface of the durable unit. The at least one sensor includes any of the example sensors detailed elsewhere herein. Additionally, in some embodiments, there are sensors on the wheels to monitor if there is a tube break or imbalance.

[0094] In some embodiments, the system comprises a light source, and at least one sensor configured to measure light absorption and / or light scattering of light emitted by the light source to detect and optionally count air bubbles in the dialysate fluid and / or determine fluid volume and / or flow rate, for example, based on detection of air bubbles.

[0095] In some embodiments, the device includes a tilting mechanism, for example to allow for the release of air bubbles from the fluid flow path. In some embodiments, precautions are taken to ensure air removal when priming the device. Furthermore, monitoring for air bubbles (and their removal) continues throughout the procedure.

[0096] For example, if the diameter of an air bubble is larger than a threshold, the air bubble is removed by reversing the flow and draining it.

[0097] Fluid flow may be measured using techniques known in the art. In this regard, air bubbles that are detected but determined to be below a threshold are allowed to remain in the tube but must be accounted for by subtracting the volume of the air bubbles.

[0098] Reference is now made to Figures 6A-6C, which illustrate the assembly of a disposable unit 500 into a durable unit 600, according to some embodiments.

[0099] According to some embodiments, a durable unit (eg, durable unit 600 ) comprises a base 602 and a door or cover 610 .

[0100] The durability unit 600 may be configured to accommodate the cartridge 500 in alignment with the pump rotor 700 such that, when assembled, the tubing included in the cartridge 500 is operatively engaged with the pump rotor 700. In some examples, the durability unit 600 may include an alignment slot 612 configured to accommodate the cartridge 500 in alignment with the pump rotor 700. In some examples, the door 610 may include an alignment slot 612.

[0101] In some embodiments, at least a portion of the door 610 is transparent, e.g., to allow visualization of a disposable unit disposed inside the durable unit or rotor of the durable unit. In some embodiments, a disposable unit (e.g., the disposable unit 500) is shaped and dimensioned to be inserted into the alignment slot 612, e.g., as shown in FIG. 6A. In some embodiments, the disposable unit 500 is inserted into the alignment slot in a direction and / or orientation indicated by at least one mark on the housing of the disposable unit 500.

[0102] According to some embodiments, after inserting the disposable unit 500 into the alignment slot 612, the door 610 is closed.

[0103] In some embodiments, the external Y-set connector 560 is connected to the Y-set tubing 506 through the opening 530 before the door 610 is closed or prior to insertion of the disposable unit 500 into the alignment slot 612. In some embodiments, the Y-set tubing 506 is connected to the external Y-set connector 560, for example, through the opening 530.

[0104] According to some embodiments, a drawer (e.g., drawer 620) of durable unit 600 extends from the durable unit housing when door 610 is closed, as shown, for example, in FIG 6B. Optionally, drawer 620 extends automatically when door 610 is closed. In some embodiments, drawer 620 includes a top opening and a side opening 622, optionally a U-shaped side opening, for placement of catheter end 550.

[0105] According to some embodiments, when the drawer 620 is closed, the catheter end 550 is pushed into the catheter connector 504. In some embodiments, once the catheter is connected through the catheter connector 504, a sterilization process is initiated. The sterilization process is described elsewhere herein.

[0106] According to some embodiments, the dialysis machine 102 operates a motor (e.g., an electric motor) to move disinfectant material through the tubing of the disposable unit and dialysate in and out of the patient's peritoneum through a catheter connected to the system. In some embodiments, the dialysis machine includes at least one battery, optionally a rechargeable battery. In some embodiments, the dialysis machine 102 includes a charging plug (not shown) for connecting an external power source to the rechargeable battery, for example to allow charging of the battery. Alternatively, the dialysis machine can be operated using an external power source instead of or in addition to the battery, by connecting the external power source to the dialysis machine.

[0107] According to some embodiments, the housing of the dialysis machine 102 includes at least one adapter for connecting, for example, a belt or harness to the dialysis machine. In some embodiments, the belt or harness is used to secure the dialysis machine to a body part of the patient (e.g., the patient's hand, leg, shoulder, thigh, and / or buttocks).

[0108] According to some embodiments, the dialysis machine 102 is portable and may be configured to be secured to a patient's body part by a belt, harness, or any adapter. In some embodiments, the dialysis machine includes a durability unit including a motor (e.g., an electric motor) and a battery (optionally a rechargeable battery electrically connected to the rotor). In some embodiments, the durability unit includes a control circuit electrically connected to the motor and the battery.

[0109] Figure 7A is an exploded view of pump rotor 700. Figure 7B is a top view of rotor 700. Figure 7C is a side view of pump rotor 700. Figure 7D is a bottom view of rotor 700. Figure 7E is a two-dimensional 3D representation of pump rotor 700.

[0110] In some embodiments, the durable unit 600 comprises a complete pump assembly, and the disposable unit or cartridge 500 is operably engagable with the complete pump assembly in a pick and place step.

[0111] The pump assembly includes a pump rotor 700 that is operably coupleable to a pump drive (not shown) that includes a shaft for rotating the pump rotor 700.

[0112] The pump rotor 700 has a rotor axis of rotation Z perpendicular to the plane of rotation of the pump rotor. The rotor 700 has at least one wheel 710 rotatably coupled (e.g., by a bearing) to the pump rotor 700. Each wheel of the at least one wheel 710 has a wheel axis of rotation W perpendicular to the rotor axis of rotation Z. When actuated, rotation of the pump rotor about the rotation axis Z causes rotation of the at least one wheel 710 about the wheel axis of rotation W such that the at least one wheel 710 traverses a circular path about the rotation axis Z and compresses a corresponding portion of the compressible tube 502 in a direction that is in the direction of the pump rotor axis of rotation Z. Rotation of the pump rotor about the rotation axis Z causes the wheel axis of rotation W to move in a circular motion about the rotor axis of rotation Z in the plane of rotor rotation. The pump motor is bidirectional, and thus the direction of rotation of the rotor is reversible.

[0113] In some instances, when the rotor direction is from the catheter connector side to the dialysate connector side, i.e., clockwise according to the illustrated embodiment, the pump pushes fluid from the catheter to the dialysate bag, in which direction fluid is drained from the peritoneal cavity to the dialysate drain bag.

[0114] For example, when the rotor direction is from the dialysate connector side to the catheter connector side, i.e., counterclockwise according to the illustrated embodiment, the pump pushes fluid from the dialysate bag to the catheter and into the peritoneal cavity. In this direction, fresh dialysate fluid is pumped from the dialysate bag into the peritoneal cavity.

[0115] The pump rotor 700 includes a main housing 702 that houses at least one wheel 710 (e.g., wheels 710A-710C). At least one wheel 710 has a rim surface configured to cancel possible differences in angular velocity as it circularly moves about the rotor axis of rotation Z. In some embodiments, at least one wheel 710 has a rim surface 720 that tapers toward the rotor axis of rotation Z. In embodiments, the rim surface is a frustum rim surface. In the illustrated embodiment, the housing houses three wheels 710.

[0116] In some examples, the top of the housing 702 may include, for example, a dome section 704 located in the center of the housing and a plateau section 706 surrounding the central dome section. In some examples, the top may include only the plateau section 706. In some embodiments, the opening 520 is shaped and sized to allow the dome section 704 of the housing 702 to pass through.

[0117] The plateau section 706 includes at least one opening 708 configured to rotatably receive at least one respective wheel 710. In the illustrated example pump rotor, there are three wheels 710A, 710B, 710C approximately equally spaced around the circumference of the plateau section 706.

[0118] The bottom of the housing has a central opening below the dome section and three additional openings below the plateau section, which are positioned to correspond to the openings in the top.

[0119] At least one rotor wheel 710, when assembled, exerts a force from the bottom upwards, or, for example, in a direction generally parallel to the rotor axis Z, on the tube portion located below the rotor wheel, compressing the tube portion into elastic deformation, thereby moving the fluid in the tube along the direction of rotation of the rotor. The rotor may be part of a durable unit.

[0120] The upper cover portion of the tube that interfaces with (e.g., rotatably receives) the pump wheel may be angled in a manner that corresponds to the angle of the wheel. The angled "roof" increases or maximizes the contact area between the wheel and the wheel-mating roof portion, for example, to prevent the pump from "skipping" at the end of each rotation.

[0121] Sensors on the wheels detect if there is a tube break or imbalance. The sensors may be included, for example, in the pump, the disposable unit, and / or the roof. In some embodiments, the rotor is supported (and levitated) by a mechanical storage element (e.g., a spring).

[0122] In some embodiments, each wheel is supported by a mechanical storage element. The rotor and wheels are designed to impart sufficient force to the tube for pumping action, but at the same time, take care to prevent tearing or other damage to the tube. In some examples, excessive pressure exerted by the rotor on the tube can be detected and a corresponding output can be generated by the system.

[0123] In some example configurations, a sprocket or hub 730 is seated within a central opening in the bottom of the housing 702, as shown, for example, in FIGURE 7D. The central hub includes a collar 732 that couples to a pump motor. The shaft of the motor coupling extends into an opening 734 inside the collar 732. The opening 734 is centrally located on the underside of the hub 730. An O-ring 736 surrounds the end of the collar and forms a watertight connection with the motor.

[0124] In the embodiment shown, the hub 730 has (e.g., three) radially extending projections 738 (one for each of the wheels 710). Each projection has a pin hole 740 for receiving a rod 712. The rods 712 couple the wheels to the housing 702. The rods 712 extend from the hub through an opening 707 and terminate in a (e.g., threaded) hole 709. The rods 712 may have internal threads.

[0125] Each of the at least one wheel 710 has a ball bearing 716 located in a central opening 714. Two spacers 718 abut on either side of the wheel. The spacers position the wheel centrally in the wheel opening 708 of the housing. During assembly of the rotor, the rod 712 is inserted through the threaded hole 709 and the first spacer 718, and the wheel 710 with the ball bearing 716 and the second spacer 718 are attached to the rod 712. The hub 730 is placed in the opening in the bottom of the housing under the dome. The rod 712 is then pushed through the opening 707 into the pin hole 740. This assembly is fixed by a fixing element (e.g. a screw or bolt) 750 inserted through the threaded hole 709 and screwed into the rod 712. For example, if the fixing element 750 is realized as a screw, the rod 712 has an internal thread complementary to the external thread of the screw.

[0126] The pump assembly or pump includes a shaft extending from a pump motor and operably coupled to a pump rotor. The shaft is configured to operably receive the pump rotor. For example, the shaft may be configured to receive the rotor in a pick-and-place assembly step along a rotor axis of rotation Z.

[0127] A circular section of the upper casing or cover portion 514 of the disposable unit 500 completes the pump assembly. The pump tube 502 is a compressible tube having a channel or interior volume for fluid flow. When operatively assembled with the pump rotor, the compressible tube is sandwiched between the rim surface 720 of the at least one wheel 710 and the circular section of the upper casing of the disposable unit 500.

[0128] As briefly mentioned herein above, Figures 8A and 8B show a flow breaker comprising or implemented by a spring member 800 in a closed configuration. Figure 8C shows the spring member 800 in an open configuration. The spring 800 serves to selectively restrict or allow the flow of fluid within the tube 502.

[0129] The spring 800 is formed from a single metal wire that has elastic properties, allowing it to return to its original shape after being deformed. The wire 800 has several sections. Each section may be angled away from the subsequent abutting section.

[0130] A first section 802 of the wire is substantially parallel to an imaginary reference plane VP that is approximately parallel to the floor of the base of the system. The wire may have a second continuous section 804 that is angled away from the first section and away from the reference plane. The first and second sections form an angle α1. In some examples, the angle α1 is about 45° (45 degrees). In other embodiments, the angle α1 may be any angle between about 35 degrees and about 65 degrees.

[0131] The wire may have a third continuous section 806 angled away from the second section. The second and third sections form an angle β. In some examples, the angle β is about a ninety degree angle or right angle. The third section 806 is elevated from the first section 802 and is perpendicular to the first section 802 and approximately parallel to a reference plane.

[0132] The wire has a fourth continuous section 808 angled away from the third section 806. The third and fourth sections form an angle β2. In some examples, the angle β2 is about a ninety degree angle or right angle. The fourth section can be approximately perpendicular to the third section and parallel to the second section 804. The fourth section 808 can extend downward from the third section 806 toward a reference plane, optionally approximately parallel to the second section 804.

[0133] A fifth section 810 of the wire is continuous with the fourth section 808 and is substantially parallel to an imaginary reference plane. The fifth continuous section 810 is angled away from the fourth section. The fourth section and the fifth section form an angle α2. In some examples, the angle α2 is about forty-five degrees. In other embodiments, the angle α2 can be any angle between about 35 degrees and about 65 degrees. The fifth section 810 is parallel to the first section 802. The first section 802 and the fifth section 810 can define a reference plane.

[0134] The sixth section 812 of the wire is continuous with the fifth section 810 and is substantially perpendicular, extending upwardly away from the reference plane and forming an angle or right angle β3 with the fifth section 810 of approximately ninety degrees.

[0135] A seventh section 814 of the wire continues from the sixth section 812, is generally parallel to the reference plane, and forms a ninety degree angle or right angle with the sixth section. The seventh section and the third section extend generally parallel to one another and define a clamping region between the two sections where the two sections abut and even contact one another in a fixed position.

[0136] The eighth section 816 is continuous with the seventh section 814. The eighth section is the final terminal section of the spring and has a complex shape shaped to secure the spring in a corresponding groove or hole in the base portion 512 of the disposable unit 500.

[0137] In use, either the second section 804 or the fourth section 808 can be biased toward the first section 802 or the fifth section 810 to move the spring from a rest position (closed) to a biased state / position (open), as shown in FIG. 8B. In use, sections 806 and 814 clamp the tube 502, as shown in FIG. 5D. In some examples, the biasing member can be a C-shaped element with a flat middle section and two vertical side sections. The biasing member moves in the direction of arrow 818, with one side section moving under the first section 802 and the other side section moving over the second section 804, moving the second section closer to the first section and expanding the clamping area between the third section 806 and the seventh section 814, as shown in FIG. 8B.

[0138] Optionally, the biasing member may be part of the base portion 512 or the cover portion 514, or may be retained between the base portion 512 and the cover portion 514. The spring may be returned to the closed state by moving the biasing member in the reverse direction (i.e., opposite to the direction of arrow 818).

[0139] 8D and 8E, dialysis system 100 includes an actuator that is controllably operable to engage the flow breaker to selectively set the flow breaker to an open configuration that allows fluid to flow through the tubing, or a closed configuration that reduces or prevents fluid flow through the tubing. Such an actuator may be included, for example, within durability unit 600.

[0140] For example, the actuator may include a slider platform 650 with a biasing element 654 fixedly coupled to the slider platform 650. In some examples, the slider platform 650 may be part of the durability unit 600.

[0141] In some embodiments, an actuator (also called a slider drive) (not shown) may be operatively coupled to the slider platform 650 to controllably cause actuation of the slider platform. In either case, the slider platform is controllably slidable in a sliding direction S to actuate (i.e., controllably change state) the flow breaker. The sliding direction SD may be located in a sliding plane that is approximately parallel to a tube plane defined by the fluid flow path defined by the tube 502, for example. For simplicity of the following description, the slider plate 652 is considered to be located on or define the sliding plane SP. In the illustrated exemplary configuration, the biasing element 654 extends perpendicularly from the plate 652 or sliding plane SP.

[0142] When the slider plate 652 is in the retracted first position (FIG. 8D), the third continuous section 806 is set to a non-actuated state and the flow breaker 508 is set to a normally closed configuration in which the tube 502 is sandwiched or compressed between two spring wire sections (e.g., between the third wire section 806 and the seventh wire section 814).

[0143] The biasing element 654 can have a groove 656 configured to slidably receive the second continuous section 804 of the wire 800. As the slider plate 652 slides from the retracted position to the advanced second position ( FIG. 8E ) by traversing a distance D in the sliding direction SD, the biasing element 654 correspondingly advances from the first position to the second position, causing the groove 656 to apply a force against the second wire section 804, bending the second wire section 804 toward the first wire section 802, thereby moving the third wire section 806 away from the seventh wire section 814.

[0144] Moving the third wire section 806 away from the seventh wire section 814 (as indicated diagrammatically by arrow K) causes the formation or increase of a gap 820 between the third wire section 806 and the seventh wire section 814, resulting in a reduction in pressure previously applied on the tube 502 by the third wire section 806 and the seventh wire section 814. The reduction in pressure and the formation of the gap 820 can increase the flow of fluids, such as fresh dialysate, spent dialysate, and / or disinfectant material, through the tube 502.

[0145] 8E-8G, in some embodiments, flow breaker 570 may be realized by employing a rotatable blocking element 572 that is rotatable from a first (closed) position that prevents or reduces fluid flow through tube 502 to a second (open) position that allows substantially unimpeded flow of fluid through tube 502.

[0146] The rotatable blocking element 572 may include, for example, a plate having a leading edge 573 and a trailing edge 574 opposite the leading edge 573. For purposes of discussion herein only, the leading edge 573 may refer to the edge of the plate that is closer to the catheter connector 504 than the Y-set connector 560 of the disposable unit 500, relative to the fluid flow path defined by the tubing 502.

[0147] In some embodiments, the rotatable blocking element 572 is biased into the closed configuration, for example, by a mechanical storage element (eg, a torsion spring).

[0148] In some embodiments, the rotatable blocking element 572 is biased into the open configuration, for example, by a mechanical storage element (eg, a torsion spring).

[0149] In some embodiments, the rotatable blocking element 572 is in an idle state for the open and closed configurations.

[0150] In the example described herein with respect to Figures 8F-8H, blocking element 572 is in a "normally open" position as shown in Figure 8F.

[0151] 8F shows rotatable blocking element 572 in a closed configuration such that leading edge 573 presses against tube 502 to impede fluid flow. Blocking element 572 may be disposed between and fixedly coupled to actuator wheels 576A, 576B. Wheels 576A, 576B include respective engagement elements (e.g., protrusions) 577A, 577B.

[0152] In the illustrated example, the actuator may include one or more pusher elements 578A, 578B that engage corresponding protrusions 577A, 577B of actuator wheels 576A, 576B to hold the blocking element 572 in the closed configuration.

[0153] Retracting pusher elements 578A, 578B, as shown generally by arrow P, along longitudinal axis T of the pusher elements rotates blocking element 572 about axis of rotation R, as shown generally by arrow M. As a result, leading edge 573 does not press against tube 502, allowing substantially unimpeded flow of fluid through tube 502, as shown generally in Figures 8G and 8H.

[0154] 8I-8K, in some embodiments, the rotatable blocking element 580 may be embodied as or may comprise a semicircular body 582 having a leading edge 583 and a trailing edge 584.

[0155] 8F-8H, when blocking element 580 is in the closed configuration (FIG. 8I), leading edge 583 exerts pressure against tube 502, impeding flow therethrough. Conversely, when blocking element 580 is in the open configuration (FIGS. 8J and 8K), fluid may flow substantially unimpeded through tube 502.

[0156] Further reference is made to Figures 8L and 8M. Figure 8L is a schematic, partial cutaway view of the disposable cartridge 500 with the blocking element 580 in a closed configuration. Figure 8M is a schematic, partial cutaway view of the disposable cartridge 500 with the blocking element 580 in an open configuration.

[0157] 9A-9C, for example, as described in PCT Application WO 2017 / 134657, entitled "DIALYSIS SYSTEM PUMP WITH CONNECTOR," filed Feb. 1, 2017, and PCT Application WO 2018 / 142406, entitled "SMART PERITONAL DIALYSIS DEVICE," filed Feb. 1, 2018, to Liberdi Inc., the entire contents of both of which are incorporated herein by reference, the tube may include one or more disinfecting lumens or chambers 513 filled with a disinfecting material.

[0158] In some embodiments, the catheter-side disinfection chamber may be surrounded, for example, by a proximal catheter septum and a distal catheter septum, and the Y-connector disinfection chamber may be surrounded, for example, by a proximal Y-connector septum and a distal Y-connector septum. The septum may be realized, for example, by a foil or a membrane.

[0159] The proximal catheter septum is a septum proximal to the patient catheter tubing 352 and the distal catheter septum is a septum distal to the patient catheter tubing 352. The proximal Y-connector septum may include or be a septum proximal to the Y-connector set 560 and the distal Y-connector septum is a septum distal to the Y-connector set 560.

[0160] Without being limiting, and merely for ease of explanation, the following description will refer to a catheter-side disinfection chamber.

[0161] In some embodiments, the catheter connector 504 can include a proximal catheter septum 534 and a piercing element 505 of a diffuser or piercing device 507 having a proximal opening and a distal opening.

[0162] In some embodiments, the slider platform is configured to securely (form-fit and / or friction-fit) receive external catheter elements, such as the catheter tube 551 and associated external catheter connector 550, and / or the Y-tube 562 and associated external Y-connector 560. Additionally, the disposable 500 is configured to securely (form-fit and / or friction-fit) receive the pump tube. When the external catheter element and the pump tube are securely attached or received, for example, by the slider platform and their respective receiving elements of the lid 610 and / or base 602, the tube axis and the external catheter element axis can be substantially aligned with one another such that displacement of the external catheter element relative to the pump tube 502 over a distance in the axial direction of the tube results in a fluid coupling between the external catheter element and the pump tube.

[0163] In some embodiments, with the slider platform in the same sliding motion relative to the pump tube 500 traversing a sufficient distance, the configuration of the flow breaker is altered to place the catheter tube 551, the external Y-tube 562, and the pump tube 502 in fluid communication with each other.

[0164] For example, pressing the patient connector 504 against the external connector 550, as shown diagrammatically by arrow D, causes a linear displacement of the external connector 550 and the patient connector 504 relative to each other, resulting in a relative displacement from an initial or closed position (FIGS. 9A and 9B) to a second or open position (FIG. 9C), whereby a leading edge or leading edge portion 554 of the external connector 550 engages the proximal catheter septum 534, causing a deformation (e.g., stretching) of the proximal catheter septum 534. Further relative displacement of the two connectors further engages the (e.g., stretched) septum against the connector's piercing element 505, eventually resulting in the piercing and / or tearing of the proximal septum by the piercing element 505, such that the external connector 550 and the patient tube connector 504 are fluidly coupled to each other. This allows disinfection fluid to flow from the disinfection chamber to the patient catheter tube. The piercing element 505 may be part of a piercing device (also called a diffuser).

[0165] In some examples, the distal bulkhead, which may be realized by a compressed tube wall (e.g., as generally described herein with respect to FIG. 8A), may be decompressed, such as by displacement in direction D, causing the spring elements 806, 814 to unclamp the tube and allow the disinfection fluid to flow outside the disinfection chamber (e.g., into an additional portion of the pump tubing). In some other embodiments, the distal bulkhead may be a second bulkhead incorporated into the connector (e.g., the catheter tube connector 504).

[0166] 10, the piercing element 505 can be configured to allow fluid to flow through an opening 553 (e.g., of the piercing device) after piercing of the proximal membrane, for example, from the disinfection chamber into the patient connector tube or from the patient connector tube to the disinfection chamber. For example, the piercing element 505 can have a broadhead shape formed by multiple blades 552 (e.g., blades 552A-552C). In some embodiments, the piercing device can include one or more spacer elements 555 to prevent sealing of the opening 553 by a leading edge or leading edge portion 554 of the external catheter connector 550.

[0167] 11A-11C, one or both connectors, e.g., the catheter connector and / or the Y-connector, may include a proximal and / or distal septum. In this manner, the antiseptic material may be stored only within the connector until it is released into the pump tubing and / or the patient catheter and / or the Y-tube. Providing such a distal septum (e.g., a valve element) contained within the connector may eliminate the need to employ a mechanical energy storage element, as shown in FIGs. 8A-8C, to clamp or compress the pump tubing to form the distal septum.

[0168] In some example implementations, each of the two connectors may include only one septum, and the antiseptic fluid may be stored in the tube 502 between the two septums. In some examples, the septum may be considered to be a flow breaker.

[0169] In some exemplary implementations, one or both connectors may include a proximal septum and a distal septum, and antiseptic fluid may be stored within the connector between each of the two septums. Again, each septum may be considered a flow breaker.

[0170] In some exemplary implementations, one or both connectors may include a proximal septum and / or a distal valve, for example, configured as further outlined below. Antiseptic fluid may be stored within the proximal septum and the distal valve. Each of the septum and the corresponding distal valve may be considered to be a flow breaker.

[0171] Depending on the context, the term "proximal septum" refers to the septum or flow breaker location closer to the opening of the corresponding connector end.

[0172] By implementing a distal septum with a valve instead of a mechanical storage element that clamps the pump tubing, assembly of the tubing within the cartridge may be facilitated.

[0173] It should be noted that although the distal septum is shown herein as being realized by a valve, this should not be construed as limiting in any way. Thus, in some alternative embodiments, the antiseptic fluid may be stored within the external connector, e.g., the proximal septum may be realized by a valve and the distal septum may be realized by a valve, e.g., the foil puncture action may occur in a direction opposite to direction D shown in Figures 9A-9C. Storing the antiseptic fluid only in the connector may provide an extended shelf life due to the lower porosity of the connector material compared to the porosity of the tubing material.

[0174] In some embodiments, the biasing element may be embodied by the proximal end of the Y-set tube 506 (proximal to the pump rotor 700) and / or the proximal end of the catheter, and upon relative displacement with respect to the respective proximal bulkhead (the Y-connector bulkhead and / or the catheter bulkhead), causes rupture of the corresponding bulkhead.

[0175] It should be noted that what is shown diagrammatically in the attached drawings and described herein are examples of embodiments in which the disposable part remains stationary relative to the durable unit and the sliding platform and / or biasing element are controllably displaced relative to the durable part and thus the disposable part, but this should not be construed as limiting in any way. Thus, in some embodiments, the system may be configured such that the disposable part is slidable relative to the biasing element (e.g., the proximal end of the Y-tube connector and / or the proximal end of the catheter tube connector and / or the spring biasing element), or both the disposable part and / or the sliding platform and / or the biasing element may be movable relative to the durable unit. In some or all embodiments, the biasing element may be considered to be an element that contributes to the opening of the flow breaker (e.g., the rupture of a corresponding septum and / or the opening of a valve and / or the biasing of a mechanical energy storage device such as a flow breaker spring to an open position).

[0176] In some examples, one or both connectors may include a diffuser (e.g., a septum wall) with multiple diffusion openings. In the closed configuration, the legs of the valve element may block the diffusion openings to prevent fluid from flowing through the diffusion openings. In the open configuration, the legs are retracted to allow fluid to flow through the diffusion openings. FIG. 11A is a schematic cross-sectional view of the catheter connector 1504 and the external connector assembly 550, in which the proximal septum 1510 is torn and the distal septum or valve element 1511 abuts or is pressed by a mechanical energy storage device (e.g., spring 1512) against the distal opening of the piercing device 507, thereby sealing the distal opening of the piercing device. Thus, the disinfection chamber, whose cavity is defined by the catheter body and the proximal and distal septums, opens on the side of the (torn) proximal septum and is closed by the distal (valve-based) septum 1511.

[0177] 11B is a schematic cross-sectional view of the catheter connector 1504 and external connector assembly 550 showing the proximal septum 1510 being torn and the distal septum or valve element 1511 being pushed away from the distal opening of the piercing device 507 by the leading edge 554 of the external connector assembly 550, thereby opening the distal opening of the piercing device. Both the inlet and outlet of the catheter connector 1504 configured in this manner are in fluid communication with the external connector and pump tubing, allowing the flow of disinfecting material through the catheter and tubing.

[0178] 11C, the housing of the connector 1504 may include a seal 1514 and an adapter 1515. The seal 1514 may be disposed between the adapter 1515 and a proximal membrane 1510. Further, the membrane 1510 may be disposed between the sealing element 1514 and a proximal opening of the diffuser / perforator 507. A distal septum (valve septum) 1511 may be disposed between the mechanical energy storage element 1511 and a distal opening of the diffuser 507. It should be noted that the Y-tube connector may be designed in a similar or similar manner.

[0179] Additionally, in some embodiments, some of the elements shown in FIG. 11C may be employed in connector embodiments in which, for example, the distal bulkhead is achieved by a clamp on the pump tubing.

[0180] 12A and 12B, the top 514 of the cartridge may include a support structure 590 for supporting the rollers 710 that traverse a circular section that does not include the pump tube 502. For example, the circular section of the cartridge may be an area within the cartridge defined by a first pump tube portion that the wheel disengages during rotation and a second pump tube portion that the wheel subsequently reengages. The support structure or platform may be configured, for example, to reduce or prevent tilt of the rotor rotation axis Z relative to the cartridge. In some examples, the wheel-engaging surface of the support structure 590 has a slope that matches the angle of the tapered rim surfaces of the wheels 710A-C.

[0181] It should be noted that at least one or all of the elements shown diagrammatically as being included in the top of the disposable cartridge may, in some embodiments, instead be disposed or included in the lid 610. For example, at least one fin (e.g., at least one straight fin 529 and / or at least one angled fin 532) and / or support structure 590 may be included as part of the lid 610 instead of being included in the top of the disposable cartridge.

[0182] 13A, a method for performing peritoneal dialysis according to some embodiments may be performed as described herein. According to some embodiments, at 910, the cap of the twin bag 908 is removed.

[0183] In some embodiments, a manual clamp 902 is added to the twin bag, for example to control the flow to and from the twin bag. Optionally, two clamps are added, one to each bag of the twin bag. In some embodiments, a disposable pump tubing 904 is connected to the twin bag. In some embodiments, the twin bag is connected to a device / system (e.g., system 300, dialysis machine 102, or dialysis machine 202). In some embodiments, once the twin bag is connected to the device, a disinfection process is initiated, for example to disinfect the flow path between the twin bag and the pump tubing.

[0184] According to some embodiments, the catheter cap is removed at 214 and the catheter (e.g., the patient's catheter) is connected to the device at 916. In some embodiments, a disinfection process is initiated during catheter connection, e.g., to disinfect the flow path between the catheter and the pump tubing. In some embodiments, the drain side of the twin bag is clamped at 918. In some embodiments, the disinfection unit is stopped at 920. In some embodiments, the catheter flow valve is opened at 922. In some embodiments, the drain side crimp is opened at 924, e.g., to allow drained dialysate to enter the drain bag.

[0185] According to some embodiments, the pump is activated at 926. In some embodiments, the pump (e.g., a peristaltic pump) rotates a rotor in a direction toward a drain bag. In some embodiments, if the drained dialysate flows into the drain bag, the pump remains activated. In some embodiments, if the drained dialysate does not flow into the drain bag, the pump is stopped at 930.

[0186] According to some embodiments, the catheter is clamped at 932. In some embodiments, the seal brakes at 934. In some embodiments, the seal brakes, for example, to allow flushing of the draining dialysate from the pump tubing. In some embodiments, the pump is activated at 936. In some embodiments, the pump is activated for a desired period of time to flush the pump tubing. In some embodiments, once the desired period of time is over, the pump is stopped at 940. In some embodiments, the drain side is clamped at 942. In some embodiments, the catheter flow valve is opened at 944, for example, to allow a flow path between the fresh dialysate bag and the catheter.

[0187] According to some embodiments, the pump is turned on at 946. In some embodiments, the pump remains on as long as dialysate flows into the catheter. In some embodiments, if dialysate does not flow into the drain bag, the pump is stopped at 950. In some embodiments, the catheter is clamped at 952, e.g., to isolate the catheter from the pump tubing. In some embodiments, the dialysate is clamped at 954. In some embodiments, the catheter flow valve is closed at 956, e.g., to prevent flow into or out of the catheter.

[0188] According to some embodiments, the catheter is undampened at 958. In some embodiments, the catheter is released or disconnected at 960. In some embodiments, a cap is placed on the catheter opening at 962. In some embodiments, the sterilization unit is stopped at 964.

[0189] According to some embodiments, the drain side is clamped at 966. In some embodiments, the twin bag is removed at 968. In some embodiments, the drain bag is drained at 970. In some embodiments, the drain bag is discarded at 972.

[0190] According to some exemplary embodiments, the disposable pump tubing 904 is also disconnected from the device. In some embodiments, a new disposable pump tubing is added to the device between the infusion and drainage processes.

[0191] Further referring to Figure 13B, according to some embodiments, at 901, a portable peritoneal dialysis disposable (PPDD) is removed from the packaging. In some embodiments, at 903, the sterility of the PPDD packaging is inspected and / or determined. In some embodiments, at 903, the sterility of the packaging is determined by inspecting the integrity of the packaging. In some embodiments, if the packaging is sterile, at 905, the PPDD is removed from the packaging.

[0192] According to some embodiments, at 907, the PPDD is loaded into a portable peritoneal dialysis machine (PPDM). In some embodiments, the PPDM is the durable part of the device and the PPDD is the disposable part of the device. In some embodiments, at 909, the tubing is removed from the packaging (optionally, the disposable packaging). In some embodiments, at 911, the tubing is inspected. In some embodiments, at 913, the "pull ring" is removed from the sterile packaging. In some embodiments, the tubing is loaded into a PP dialysis disposable. Optionally, the tubing is placed in association with the pump rotor of the PP dialysis disposable.

[0193] According to some embodiments, at 915, tubing is attached to a PP dialysis disposable.

[0194] In some embodiments, the catheter cap (e.g., patient catheter cap) is removed at 917. In some embodiments, the catheter is loaded into a PP dialysis disposable at 919. Optionally, while loading the catheter, the catheter is disinfected by a disinfectant connector of the PPDD.

[0195] According to some embodiments, at 921, the lid of the PP dialysis machine is closed. Optionally, closing the lid initiates a catheter disinfection process. In some embodiments, at 923, the catheter flow valve is opened. In some embodiments, at 925, a seal (e.g., a "green" seal) is broken. Optionally, breaking the seal releases a disinfecting solution into the catheter. In other embodiments, the disinfection process is performed in the manner described above or one of the methods described above.

[0196] According to some embodiments, a disinfection timer is started at 927. In some embodiments, the disinfection timer is stopped at 929. In some embodiments, the disinfection timer is set for a desired period of time sufficient to disinfect the flow path between the tubing and the catheter. In some embodiments, the drain clamp is opened at 931. In some embodiments, the pump is activated at 933, for example to drain dialysate from the peritoneal cavity. In some embodiments, the pump remains activated if fluid is drained at 935. In some embodiments, the pump is stopped at 937 if there is no fluid to drain.

[0197] According to some embodiments, the catheter is clamped at 939. In some embodiments, the pump is turned on at 941, for example to remove residual drain dialysate from the tubing. In some embodiments, the pump is turned on for at least 2 seconds (e.g., 2, 3, 4, 5, 6, 7 seconds, or an intermediate or longer period, optionally with a timer, at 943, or until there is no residual fluid in the tubing. In some embodiments, the pump is stopped at 945. In some embodiments, the drain side is clamped at 947.

[0198] According to some embodiments, the catheter clamp is released. In some embodiments, the dialysate clamp is released. In some embodiments, the pump is activated at 949, for example, to allow for infusion of dialysate into the catheter. In some embodiments, dialysate flows into the catheter at 951. In some embodiments, the pump remains activated as long as dialysate flows into the catheter. In some embodiments, the pump is stopped at 953 when dialysate does not flow into the catheter. Optionally, the pump is stopped according to the operating parameters of the treatment protocol. In some embodiments, the catheter is clamped at 955. In some embodiments, the dialysate is clamped at 957. In some embodiments, the catheter flow valve is closed at 959.

[0199] According to some embodiments, the lid of the PP dialysis machine is opened at 961. In some embodiments, all clamps are opened at 963. In some embodiments, the catheter is released from the PP dialysis disposable at 965. In some embodiments, a cap is attached to the catheter opening.

[0200] According to some embodiments, the PP dialysis disposable is removed from the PP dialysis machine at 969. In some embodiments, the rotor is removed from the PPDD at 971. In some embodiments, the drain bag is drained at 973. In some embodiments, the drain bag is discarded at 975. Optionally, the PP dialysis disposable or just the tubing is discarded at 975.

[0201] Further Examples

[0202] Example 1 relates to a pump rotor of a pump, the pump rotor being operably connectable to a pump drive of the pump, the pump rotor having a rotor rotation axis Z perpendicular to a plane of rotation of the pump rotor, the pump rotor comprising at least one wheel rotatably connected to the pump rotor and having a wheel rotation axis W perpendicular to the rotor rotation axis Z, wherein rotation of the pump rotor about the rotation axis Z rotates the at least one wheel about the wheel rotation axis W such that the at least one wheel traverses a circular path about the rotation axis Z and compresses a corresponding portion of a compressible tube in a direction that is in the direction of the pump rotor axis.

[0203] Example 2 includes the subject matter of example 1, optionally wherein rotation of the pump rotor about its axis of rotation Z causes the wheel axis of rotation W to move in a circular motion about the rotor axis of rotation Z in the plane of rotor rotation.

[0204] Example 3 includes the subject matter of any one of Examples 1 to 2, and optionally, at least one wheel has a rim surface configured to cancel out differences in angular velocity when circularly moving about the rotor rotation axis Z.

[0205] Example 4 includes the subject matter of any one of examples 1 to 3, optionally, wherein at least one wheel has a rim surface that tapers towards the rotor rotation axis Z.

[0206] Example 5 includes the subject matter of example 4, optionally wherein the rim surface is a frustum rim surface.

[0207] Example 6 includes the subject matter of any one or more of Examples 1 to 5, and optionally, the shaft is configured to operably receive the pump rotor in a pick-and-place assembly step in the direction of the rotor rotation axis Z.

[0208] Example 7 relates to a disposable component that includes a compressible tube having a channel for fluid flow, where when operatively assembled with the pump rotor, the compressible tube is sandwiched between a rim surface and a rotor housing.

[0209] Example 8 includes the subject matter of example 7, optionally including an actuatable mechanical energy storage element configured to compress the tube to form a sterilizing portion that includes the sterilizing material.

[0210] Example 9 includes the subject matter of example 8, optionally, wherein the actuatable mechanical energy storage element is reversibly or irreversibly configurable from a closed configuration to an open configuration.

[0211] Example 10 includes the subject matter of example 8 and / or example 9, optionally, wherein the actuatable mechanical energy storage element is reversibly or irreversibly configurable from an open configuration to a closed configuration.

[0212] Example 11 includes the subject matter of any one or more of Examples 8-10, and optionally, the actuatable mechanical energy storage element is a spring that compresses the tube to form a disinfecting portion containing the disinfecting material.

[0213] Example 12 includes the subject matter of any one or more of Examples 7-11, and optionally, relative motion can be controllably initiated between the spring and a biasing element that releases pressure applied by the spring to the tube, thereby allowing flow of disinfecting material into the tube.

[0214] Example 13 includes the subject matter of example 11 and / or example 12, optionally wherein the spring is normally closed having a closed state in which a portion of the spring presses against a tube of the disposable part.

[0215] Example 14 includes the subject matter of any one or more of Examples 7-13, wherein the disposable part is operably engagable with a pump rotor of a peritoneal dialysis device, e.g., as disclosed herein.

[0216] Example 15 includes the subject matter of example 14, optionally wherein the pump rotor is part of a durable unit of a peritoneal dialysis machine. In some embodiments, the pump rotor can be a durable pump rotor.

[0217] In some examples, the actuatable mechanical energy storage element and / or actuator may be part of the durability unit.

[0218] While the invention has been described with respect to a limited number of embodiments, it will be understood that many variations, modifications, and other applications of the invention are possible, and therefore the claimed invention as set forth in the following claims is not limited to the embodiments described herein.

[0219] It is important to note that the methods described herein and illustrated in the accompanying drawings should not be construed as limiting. For example, the methods described herein may include additional or fewer processes or operations compared to those described herein and / or illustrated in the drawings. In addition, the method steps are not necessarily limited to the chronological order as illustrated and described herein.

[0220] Any digital computer system, unit, device, module, and / or engine illustrated herein may be configured or otherwise programmed to implement the methods disclosed herein, and is within the scope and spirit of the present disclosure as long as the system, module, and / or engine is configured to implement such methods. When a system, module, and / or engine is programmed to perform a specific function according to computer-readable and executable instructions from a program software that implements the methods disclosed herein, it effectively becomes a dedicated computer specific to the embodiment of the methods disclosed herein. The methods and / or processes disclosed herein may be implemented as a computer program product, which may be tangibly embodied in an information carrier, including, for example, a non-transitory tangible computer-readable storage device and / or a non-transitory tangible machine-readable storage device. The computer program product may be directly loadable into the internal memory of a digital computer, including software code portions for executing the methods and / or processes disclosed herein.

[0221] The methods and / or processes disclosed herein may be implemented as a computer program that may be intangibly embodied by a computer-readable signal medium. The computer-readable signal medium may include a propagated data signal in which the computer-readable program code is embodied, for example, in baseband or as part of a carrier wave. Such a propagated signal may take any of a variety of forms, including, but not limited to, an electromagnetic signal, an optical signal, or any suitable combination thereof. The computer-readable signal medium may be any computer-readable medium that is not a non-transitory computer or machine-readable storage device, but can communicate, propagate, or port a program for use by or in connection with the devices, systems, platforms, methods, operations, and / or processes described herein.

[0222] The terms "non-transitory computer-readable storage" and "non-transitory machine-readable storage" encompass distribution media, intermediate storage media, computer execution memory, and any other medium or device that can be stored for subsequent reading by a computer program that implements an embodiment of the method disclosed herein. A computer program product can be deployed to be executed on one computer or on multiple computers at one site or distributed across multiple sites and interconnected by one or more communications networks.

[0223] These computer-readable and executable instructions can be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, whereby the instructions, executing via the processor of the computer or other programmable data processing apparatus, create means for implementing the function / act specified in the block(s) of the flowcharts and / or block diagrams. These computer-readable and executable program instructions can further be stored in a computer-readable storage medium that can direct a computer, programmable data processing apparatus, and / or other device to function in a particular manner, whereby the computer-readable storage medium on which the instructions are stored comprises an article of manufacture containing instructions that implement aspects of the function / act specified in the block(s) of the flowcharts and / or block diagrams.

[0224] The computer-readable and executable instructions may further be loaded into a computer, other programmable data processing apparatus, or other device and cause the computer, other programmable apparatus, or other device to perform a series of operational steps to generate a computer-implemented process, such that the instructions executing on the computer, other programmable apparatus, or other device implement the function / act specified in the block(s) of the flowcharts and / or block diagrams.

[0225] The term "engine" may include one or more computer modules, which may be self-contained hardware and / or software components that interface with a larger system. A module may include one or more machine-executable instructions. A module may be embodied by a circuit or circuit configuration, or a controller programmed to cause the system to perform the methods, processes, and / or operations disclosed herein. For example, a module may be implemented as a hardware circuit including, for example, custom VLSI circuits or gate arrays, application specific integrated circuits (ASICs), off-the-shelf semiconductors (such as logic chips, transistors, and / or other discrete components). A module may be implemented within a programmable hardware device, such as a field programmable gate array, programmable array logic, programmable logic device, or the like.

[0226] The term "random" also encompasses the meaning of the terms "substantially randomly" or "pseudo-randomly."

[0227] As used herein, the term "real-time" generally refers to updating information based on received data essentially as fast as the data is received, for example, without any judder, latency, or lag noticeable to a user.

[0228] In the description, unless otherwise stated, adjectives such as "substantially" and "about" modifying a condition or relationship characteristic of one or more features of an embodiment of the present invention should be understood to mean that the condition or characteristic is defined within an acceptable tolerance for the operation of the embodiment for its intended use.

[0229] Unless otherwise specified, the terms "substantially," "about," and / or "near" with respect to a magnitude or value may mean within an inclusive range of -10% to +10% of the respective magnitude or value.

[0230] "Coupled" can mean indirectly or directly "coupled."

[0231] It is important to note that the methods may include but are not limited to those figures or the corresponding descriptions. For example, the methods may include additional or fewer processes or operations compared to those shown in the figures. Furthermore, the method embodiments are not necessarily limited to the chronological order as shown and described herein.

[0232] For example, descriptions herein utilizing terms such as "processing," "calculating," "computing," "determining," "establishing," "analyzing," "checking," "estimating," "deriving," "selecting," "inferring," and the like, may refer to operation(s) and / or process(es) of a computer, computing platform, computing system, or other electronic computing device that manipulates and / or transforms data represented as physical (e.g., electronic) quantities in the computer's registers and / or memory into other data similarly represented as physical quantities in the computer's registers and / or memory, or other information storage medium that may store instructions for performing operations and / or processes. The term "determining" may also refer to "heuristically determining," where applicable.

[0233] It should be noted that when an embodiment refers to a condition "above the threshold", this should not be interpreted as excluding an embodiment referring to a condition "above the threshold". Similarly, when an embodiment refers to a condition "below the threshold", this should not be interpreted as excluding an embodiment referring to a condition "below the threshold". It is clear that a condition should be interpreted as being met if the value of a given parameter is above the threshold, and that the same condition is not considered to be met if the value of the given parameter is below the given threshold. Conversely, if a condition is interpreted as being met if the value of a given parameter is above the threshold, then the same condition is not considered to be met if the value of the given parameter is below the given threshold (and only below the given threshold).

[0234] When a claim or the specification refers to an element and / or feature ("a" or "an"), it is to be understood that such a reference is not to be construed as indicating the presence of only one of that element. Thus, for example, a reference to "an element" or "at least one element" can also encompass "one or more elements."

[0235] Terms used in the singular shall include the plural unless expressly stated otherwise or unless the context otherwise requires.

[0236] In this specification and claims, the verbs "comprise," "include," and "have," and each of their conjugations, are used to indicate that the data portion or portions of the verb are not necessarily a complete recitation of components, elements, or portions of the subject portion or portions of the verb.

[0237] Unless otherwise indicated, the use of the phrase "and / or" between the last two elements of a list of options for selection indicates that one or more of the listed options are appropriate and may be selected. Furthermore, the use of the phrase "and / or" may be used interchangeably with the phrases "at least one of," "any one of," or "one or more of," followed by a list of various options.

[0238] As used herein, the phrase "A, B, C, or any combination of the foregoing" should be interpreted as meaning (i) A or B or C, or any combination of A, B, C, (ii) at least one of A, B, C, (iii) A and / or B and / or C, and (iv) all of A, B, and / or C. Where appropriate, the phrase "A, B and / or C" may be interpreted as meaning A, B, or C. The phrase "A, B, or C" may be interpreted as meaning "selected from the group consisting of A, B, C." This concept is illustrated for three elements (i.e., A, B, C), but is extended to fewer and greater numbers of elements (e.g., A, B, C, D, etc.).

[0239] It is understood that certain features of the invention that are described for clarity in the context of separate embodiments or examples may also be provided in combination in one embodiment. Conversely, various features of the invention that are described for brevity in the context of a single embodiment, example, and / or option may also be provided separately or in any suitable subcombination, or as suitable in any other described embodiment, example, or option of the invention. Some features that are described in the context of various embodiments, examples, and / or optional implementations should not be considered essential features of those embodiments, examples, and / or optional implementations, unless the embodiments, examples, and / or optional implementations are inoperable without those elements.

[0240] It should be noted that the terms "in some embodiments," "according to some embodiments," "for example," "eg," "for instance," and "optionally" may be used interchangeably herein.

[0241] The number of elements shown in the figures should not be construed as limiting in any way but is shown for illustrative purposes only.

[0242] "Real-time," as used herein, generally refers to updating of information at essentially the same rate as the data is received. More specifically, in the context of the present invention, "real-time" is intended to mean that image data is acquired, processed, and transmitted from a sensor at a sufficiently high data rate and sufficiently low time delay such that, when the data is displayed, the portion of the data presented and / or displayed in the visualization moves smoothly without any user-noticeable judder, latency, or lag.

[0243] It should be noted that the term "operable to" can encompass the meaning of the term "modified or configured to." In other words, a machine "operable to" perform a task can, in some embodiments, encompass the mere ability to perform (e.g., "modified to") a function, and in some other embodiments, can encompass a machine that is actually made (e.g., "configured") to perform a function.

[0244] Terms relating to location such as "top," "lower," "right," "left," "bottom," "down," "down," "low," "top," "upper," "high," "vertical," and "horizontal," and grammatical variations thereof, do not necessarily indicate, for example, that a "bottom" component is below a "top" component, or that a component "below" is "actually below" another component, or that a component "on" is "actually above" another component, and thus orientation, components, or both, may be inverted, rotated, moved, positioned in a diagonal orientation or position, positioned horizontally or vertically, or similarly modified in space. Thus, it will be understood that the terms "bottom," "lower," "top," and "upper" may be used herein merely for illustrative purposes to indicate the relative positioning or placement of certain components, to indicate first and second components, or both.

[0245] "Coupled" means indirectly or directly "coupled."

[0246] It should be noted that the term "light" as used herein may refer to electromagnetic radiation of any wavelength suitable for the purposes of the applications disclosed herein. Thus, the term "light" should not be construed as being limited to visible light, but may additionally or alternatively include non-visible radiation, such as, for example, laser light in the infrared range and UV light.

[0247] Thus, the term "light" should not be construed as being limited to visible light, but may additionally or alternatively include non-visible radiation, such as, for example, light in the infrared range, light in the short wavelength infrared range, light in the ultraviolet range, etc. Light may be coherent, non-coherent, or partially coherent. Light may be polarized, unpolarized, or partially polarized. Light may have a broad spectral width (e.g., in the range of hundreds of nanometers, as occurs from a black body), light may have an intermediate spectral width (e.g., in the range of tens of nanometers, as occurs from an LED), or light may have a narrow spectral width (e.g., in the range of a few nanometers, as occurs from a laser). Furthermore, the terms "light" and "EM radiation" may be used interchangeably herein.

[0248] Throughout this application, various embodiments may be presented and / or associated with a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the embodiments. Thus, the description of a range should be considered to specifically disclose all possible subranges and individual numerical values ​​within that range. For example, the description of a range such as 1-6 should be considered to specifically disclose subranges such as 1-3, 1-4, 1-5, 2-4, 2-6, 3-6, etc., as well as individual numerical values ​​within that range, e.g., 1, 2, 3, 4, 5, 6. This applies regardless of the breadth of the range.

[0249] The phrases "range" between a first designated number and a second designated number and "range" from a first designated number to a second designated number are used interchangeably herein and are meant to include the first designated number and the second designated number and all fractional and integer numbers therebetween.

[0250] While the invention has been described in terms of a limited number of embodiments, these should not be construed as limitations on the scope of the invention, but rather as illustrations of some of the embodiments.

Claims

1. 1. A peritoneal dialysis system, comprising: A controller; A durability unit, a disposable unit comprising a housing and removably connectable to the durable unit, the disposable unit being configured to receive a tube having a channel, the tube being compressible by a pump wheel to induce fluid flow within the channel; Equipped with the disposable unit and / or the tube comprises at least one flow breaker configured to interrupt the flow of fluid through the tube; The durability unit further comprises a slider platform for receiving at least one biasing element; the peritoneal dialysis system includes at least one actuator controllable by the controller; the slider platform is actuated by the at least one actuator to controllably slide relative to the at least one flow breaker in a sliding direction SD from a retracted position to an advanced position in a sliding plane SP generally parallel to a tube surface defined by a fluid flow passage defined by the tube; Sliding of the slider platform from the retracted position to the advanced position causes the at least one biasing element to change a flow breaker configuration of the at least one flow breaker from a closed configuration to an open configuration to allow fluid flow through the tube.

2. 10. The dialysis system of claim 1, wherein the at least one flow breaker is reversibly or irreversibly configurable from the closed configuration to the open configuration.

3. 10. The dialysis system of claim 1, wherein the at least one flow breaker is reversibly or irreversibly configurable from the open configuration to the closed configuration.

4. The dialysis system according to any one or more of claims 1 to 3, wherein the flow breaker is a septum and / or a valve incorporated in the tube.

5. The dialysis system of any one or more of claims 1 to 4, wherein the at least one flow breaker is an actuatable mechanical energy storage element.

6. 6. The dialysis system of claim 5, wherein the mechanical energy storage element is a spring configured to compress the tube.

7. 7. The dialysis system of claim 6, wherein the spring is normally closed having a closed state in which a portion of the spring presses against a tube.

8. 8. The dialysis system of claim 1, wherein the at least one flow breaker is a rotatable blocking element that is rotatable from the closed position to the open position to allow substantially unimpeded flow of fluid through the tube.

9. the disposable unit includes a Y connector end and a catheter end, both of which open in the same direction; 9. The dialysis system of claim 1, wherein the system is configured to create a relative displacement between the slider platform and the at least one flow breaker and to actuate the relative displacement between the at least one flow breaker and the biasing element to change the at least one flow breaker from a closed configuration to an open configuration to allow fluid flow through the tube.

10. 10. The dialysis system of claim 9, wherein the slider platform includes a protuberance relative to a base that is shaped and dimensioned to accommodate a Y-set tubing for connecting an end of the Y-set tubing with the Y-connector of the tubing housed by the disposable unit.

11. The dialysis system according to any one or more of claims 1 to 10, wherein the tubing includes at least one disinfecting section that includes a disinfecting material.

12. 12. The dialysis system of claim 11, wherein the disinfectant portion is trapped between the compressed tube wall and the septum membrane.

13. 13. The dialysis system of claim 12, further comprising a piercing device, wherein relative displacement between the slider platform and the flow breaker causes piercing of the septum membrane by the piercing device.

14. The dialysis system of any one or more of claims 1 to 13, wherein the pump drive is part of the durable unit.

15. The dialysis system of any one or more of claims 1 to 14, further comprising a controller configured to control the dialysis treatment process.

16. Further comprising a pump rotor; the pump rotor is operably connectable to the pump drive of the pump, the pump rotor having a rotor axis of rotation Z perpendicular to a plane of rotation of the pump rotor; the pump rotor comprises at least one wheel rotatably coupled to the pump rotor and having a wheel rotation axis W perpendicular to the rotor rotation axis Z; 16. The dialysis system of claim 1, wherein rotation of the pump rotor about the axis of rotation Z rotates the at least one wheel about the wheel axis of rotation W such that the at least one wheel traverses a circular path about the axis of rotation Z and compresses a corresponding portion of the compressible tubing in a direction that is in the direction of the pump rotor axis.

17. 17. The dialysis system of claim 16, wherein rotation of the pump rotor about the axis of rotation Z causes the wheel axis of rotation W to move in a circular motion about the rotor axis of rotation Z in the plane of rotor rotation.

18. 18. A dialysis system according to claim 16 and / or claim 17, wherein the at least one wheel has a rim surface configured to cancel differences in angular velocity when circularly moving about the rotor rotation axis Z.

19. A dialysis system according to any one or more of claims 16 to 18, wherein the at least one wheel has a rim surface that tapers towards the rotor rotation axis Z.

20. 20. The dialysis system of claim 19, wherein the rim surface is a frustum rim surface.

21. A dialysis system according to any one or more of claims 16 to 20, wherein the pump rotor is configured to be operably receivable by a shaft of the pump in a pick-and-place assembly step in the direction of the rotor rotation axis Z.

22. 22. The dialysis system of claim 16, wherein the upper portion of the disposable unit includes a support structure for supporting the at least one wheel traversing the circular section free of the pump tube.

23. 1. A peritoneal dialysis system, comprising: A controller; a resistance unit configured to receive at least one biasing element; a disposable unit comprising a housing and removably connectable to the durable unit, the disposable unit configured to receive a tube having a channel, the tube being compressible by a pump wheel to induce fluid flow within the channel; Equipped with the tube and / or the disposable unit comprises at least one flow breaker configured to interrupt the flow of fluid through the tube; and the peritoneal dialysis system includes at least one actuator controllable by the controller; 11. A peritoneal dialysis system, wherein the at least one flow breaker and / or the at least one biasing element can be actuated by the at least one actuator to controllably slide the at least one flow breaker and / or the at least one biasing element relative to one another and change the at least one flow breaker from a closed configuration to an open configuration to allow fluid flow through the tube.

24. 24. The dialysis system of claim 23, wherein the at least one flow breaker is reversibly or irreversibly configurable from the closed configuration to the open configuration.

25. 25. The dialysis system of claim 23 and / or claim 24, wherein the at least one flow breaker is reversibly or irreversibly configurable from the open configuration to the closed configuration.

26. The dialysis system of any one or more of claims 23 to 25, wherein the at least one flow breaker is an actuatable mechanical energy storage element.

27. 27. The dialysis system of claim 26, wherein the mechanical energy storage element is a spring configured to compress the tube.

28. 28. The dialysis system of claim 27, wherein the spring is normally closed having a closed state in which a portion of the spring presses against a tube.

29. The dialysis system of any one or more of claims 23 to 28, wherein the at least one flow breaker is a rotatable blocking element that is rotatable from the closed position to the open position to allow substantially unimpeded flow of fluid through the tube.

30. the disposable unit includes a Y connector end and a catheter end, both of which open in the same direction; 30. The dialysis system of claim 23, wherein the system is configured to cause a relative displacement between the at least one biasing element and the at least one flow breaker to change the at least one flow breaker from a closed configuration to an open configuration to allow fluid flow through the tube.

31. 31. The dialysis system of claim 30, wherein the sliding platform includes a ridge relative to a base that is shaped and dimensioned to receive a Y-set tubing for connecting a Y-set tubing end with the Y-connector of the tubing received by the disposable unit.

32. The dialysis system according to any one or more of claims 23 to 31, wherein the tube comprises at least one disinfecting section comprising a disinfecting material.

33. 33. The dialysis system of claim 32, wherein the disinfectant portion is trapped between the compressed tube wall and the septum membrane.

34. 34. The dialysis system of claim 33, comprising a piercing device, wherein relative displacement between the slider platform and the flow breaker causes piercing of the septum membrane by the piercing device.

35. The dialysis system of any one or more of claims 23 to 34, wherein the pump drive is part of the durable unit.

36. The dialysis system of any one or more of claims 23 to 35, further comprising a controller configured to control the dialysis treatment process.

37. Further comprising a pump rotor; the pump rotor is operably connectable to the pump drive of the pump, the pump rotor having a rotor axis of rotation Z perpendicular to a plane of rotation of the pump rotor; the pump rotor comprises at least one wheel rotatably coupled to the pump rotor and having a wheel rotation axis W perpendicular to the rotor rotation axis Z; 37. The dialysis system of claim 23, wherein rotation of the pump rotor about the axis of rotation Z rotates the at least one wheel about the wheel axis of rotation W such that the at least one wheel traverses a circular path about the axis of rotation Z and compresses a corresponding portion of the compressible tubing in a direction that is in the direction of the pump rotor axis.

38. 38. The dialysis system of claim 37, wherein rotation of the pump rotor about the axis of rotation Z causes the wheel axis of rotation W to move in a circular motion about the rotor axis of rotation Z in the plane of rotor rotation.

39. 39. A dialysis system as described in claim 37 and / or claim 38, wherein the at least one wheel has a rim surface configured to cancel differences in angular velocity when circularly moving about the rotor rotation axis Z.

40. A dialysis system according to any one or more of claims 38 to 39, wherein the at least one wheel has a rim surface that tapers towards the rotor rotation axis Z.

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