Valve actuation systems and related methods

Abstract

In one aspect, a valve actuation system includes a drive unit including an actuator configured to engage and move a plurality of valves disposed within a fluid cartridge to selectively open and close each of the plurality of valves; and a positioning frame disposed adjacent the fluid cartridge, along which the drive unit is movable in three dimensions to align the actuator with a selected one of the plurality of valves.

Description

[0001] This application is a divisional application of the invention patent application with application date of July 23, 2019, application number 201980062699.5 (PCT / US2019 / 043023), and invention name “Valve Actuation System and Related Methods”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to U.S. Provisional Patent Application No. 62 / 711,873, filed on July 30, 2018, the entire contents of which are incorporated herein by reference. Technical Field

[0004] The present disclosure relates to an actuation system for controlling a valve of a dialysis fluid cassette. Background Art

[0005] Dialysis is a medical treatment method that provides life-saving support for patients with renal insufficiency. Two main dialysis methods are hemodialysis (HD) and peritoneal dialysis (PD). During HD, the patient's blood passes through the dialyzer of the dialysis machine, and the dialysis solution (or dialysate) is usually passed through the dialyzer in the reverse or countercurrent direction. The semipermeable membrane in the dialyzer separates the blood from the dialysate and allows fluid exchange to occur between the dialysate and the blood flow via diffusion, osmosis and convection flow. These exchanges across the membrane remove waste (e.g., solutes such as urea and creatinine) from the blood. These exchanges also help regulate the level of other substances (e.g., sodium and water) in the blood. In this way, the dialyzer and the dialysis machine can serve as an artificial kidney for purifying blood.

[0006] During PD, the patient's peritoneal cavity is regularly infused with dialysate. The membranous lining of the patient's peritoneum acts as a natural semipermeable membrane, allowing diffusion and osmotic exchange between the solution in the peritoneal cavity and the bloodstream. Like HD, these exchanges across the patient's peritoneum result in the removal of waste products from the blood and help regulate the levels of other substances in the blood (e.g., sodium and water).

[0007] Automated PD machines (e.g., PD cyclers) are designed to control the entire PD process so that it can be performed at home, usually at night without the involvement of clinical staff. This process is called continuous cycle assisted PD (CCPD). Many PD cyclers are designed to automatically inject, retain, and drain dialysate from the patient's peritoneal cavity. Treatment usually lasts for several hours, usually starting with an initial drain cycle to empty the peritoneal cavity of used or used dialysate. The sequence will then continue in sequence through a series of filling, retention, and draining stages.

[0008] Throughout a dialysis treatment, various fluid pathways within the dialysis system must be managed via the selective actuation of a plurality of dialysis fluid cassette valves. Summary of the invention

[0009] The present disclosure relates to an actuation system for controlling a valve of a cassette within a dialysis system.

[0010] In one aspect, a valve actuation system includes: a drive unit, the drive unit including an actuator configured to engage and move a plurality of valves disposed within a fluid box to selectively open and close each of the plurality of valves; and a positioning frame disposed adjacent to the fluid box, the drive unit being movable in three dimensions along the positioning frame to align the actuator with a selected valve of the plurality of valves.

[0011] Implementations may include one or more of the following features.

[0012] In some embodiments, the drive unit is carried by the positioning frame.

[0013] In some embodiments, the actuator is formed to mate with a matching feature of each valve of the plurality of valves.

[0014] In some embodiments, the actuator is configured to be controllable to apply a force to each valve of the plurality of valves to rotate each valve of the plurality of valves.

[0015] In some embodiments, the actuator is configured to open and close each valve of the plurality of valves.

[0016] In some embodiments, the force is a rotational force.

[0017] In some embodiments, the positioning frame further comprises a first linear guide, a second linear guide and a third linear guide, and the drive unit can be linearly moved along the first linear guide, the second linear guide and the third linear guide to align the actuator with the selected valve.

[0018] In some embodiments, the drive unit is configured to be able to move across the first, second and third linear guides in a total time of up to about 0.5 seconds to about 2.0 seconds.

[0019] In some embodiments, the actuator is configured to open a selected valve to allow fluid to pass through the selected valve.

[0020] In some embodiments, the actuator is configured to close a selected valve to prevent fluid from passing through the selected valve.

[0021] In some embodiments, the actuator is configured to be controllable to apply a force to each valve of the plurality of valves to move each valve of the plurality of valves in a vertical direction.

[0022] In some embodiments, the actuator is configured to be controllable to push, pull or slide each valve of the plurality of valves.

[0023] In another aspect, a dialysis system includes: a fluid box carrying a plurality of valves; a valve actuation system; and a control unit configured to control the movement of the valve actuation system. The actuation system includes: a drive unit including an actuator configured to engage and move a plurality of valves disposed within the fluid box to selectively open and close each of the plurality of valves; and a positioning frame disposed adjacent to the fluid box, along which the drive unit can move in three dimensions to align the actuator with a selected valve of the plurality of valves.

[0024] Implementations may include one or more of the following features.

[0025] In some embodiments, the drive unit is carried by the positioning frame.

[0026] In some embodiments, the actuator is formed to mate with a matching feature of each valve of the plurality of valves.

[0027] In some embodiments, the actuator is configured to be controllable to apply a force to each valve of the plurality of valves to rotate each valve of the plurality of valves.

[0028] In some embodiments, the actuator is configured to open and close each valve of the plurality of valves.

[0029] In some embodiments, the force is a rotational force.

[0030] In some embodiments, the positioning frame further comprises a first linear guide, a second linear guide and a third linear guide, and the drive unit can be linearly moved along the first linear guide, the second linear guide and the third linear guide to align the actuator with the selected valve.

[0031] In some embodiments, the drive unit is configured to be able to move across the first, second and third linear guides in a total time of up to about 0.5 seconds to about 2.0 seconds.

[0032] In some embodiments, the actuator is configured to open a selected valve to allow fluid to pass through the selected valve.

[0033] In some embodiments, the actuator is configured to close a selected valve to prevent fluid from passing through the selected valve.

[0034] In some embodiments, the actuator is configured to be controllable to apply a force to each valve of the plurality of valves to move each valve of the plurality of valves in a vertical direction.

[0035] In some embodiments, the actuator is configured to be controllable to push, pull or slide each valve of the plurality of valves.

[0036] Embodiments may provide one or more of the following advantages.

[0037] Due to the ability of the actuation system to control multiple valves of the cassette, the design of a dialysis system including the actuation system can be simplified (e.g., including fewer components and / or requiring fewer control algorithms) compared to conventional dialysis systems that require a dedicated mechanism to actuate each valve of the cassette.

[0038] Other aspects, features, and advantages will be apparent from the description, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 is a perspective view of a fluid conditioning system that may cooperate with a dialysis system to perform a fluid conditioning cycle including a dialysis treatment.

[0040] Figure 2 yes Figure 1 Top view of the fluid conditioning system.

[0041] Figure 3 yes Figure 1 Front view of the fluid conditioning system.

[0042] Figure 4 yes Figure 1 Rear view of the fluid conditioning system.

[0043] Figure 5 yes Figure 1 A rear view of a fluid conditioning system with certain exterior components omitted to expose certain interior components.

[0044] Figure 6 yes Figure 1 A perspective view of a fluid conditioning system with certain exterior components omitted to expose certain interior components.

[0045] Figure 7 yes Figure 1 A perspective view of a fluid conditioning system with certain exterior components omitted to expose certain interior components.

[0046] Figure 8 yes Figure 1 A perspective view of a fluid conditioning system with certain exterior components omitted to expose certain interior components.

[0047] Fig. 9 yes Figure 1 A perspective view of the front assembly of a fluid conditioning system.

[0048] Fig.10 yes Fig. 9 A rear perspective view of the front assembly of FIG.

[0049] Fig.11 yes Fig. 9 A rear perspective view of the front assembly of FIG.

[0050] Fig.12 yes Fig. 9 A rear perspective view of the heater bag of the door assembly of the front assembly.

[0051] Fig.13 yes Fig. 9 A rear perspective view of the heater plate of the door assembly of the front assembly.

[0052] Fig.14 It shows Fig.12 Heater bags and Figure 1 A perspective view of an installation of a fluid cartridge of a fluid conditioning system.

[0053] Fig.15 yes Fig.14 Fluid Box and Fig.12 A perspective view of a heater bag.

[0054] Fig.16 Can be included in Figure 1 A fully exploded perspective view of one embodiment of a heater assembly within a fluid conditioning system.

[0055] Fig.17 yes Fig.16 A partially exploded perspective view of a heater assembly.

[0056] Fig.18 An operation diagram is provided through which Figure 1 The fluid conditioning system can cooperate with the dialysis system to form a fluid circuit for performing a fluid conditioning cycle.

[0057] Fig.19 Shows Figure 1 Fluid conditioning systems and Fig.16 An example setup of a dialysis system.

[0058] Fig. 20 Shown by Fig.16 FIG. 4 shows the fluid flow paths (indicated by highlighted fluid lines) of a fluid circuit performing the priming phase of a fluid conditioning cycle.

[0059] Fig.21 Shown by Fig.16Schematic diagram of the fluid circuit performing the fluid flow paths of the infusion phase of a fluid conditioning cycle (indicated by highlighted fluid lines).

[0060] Fig. 22 Shown by Fig.16 Schematic diagram of a fluid circuit illustrating the fluid flow paths (indicated by highlighted fluid lines) of a treatment phase of a fluid conditioning cycle performed by the fluid circuit.

[0061] Fig.23 Provided Figure 1 Block diagram of the control system of a fluid conditioning system.

[0062] Fig.24 Provided Figure 1 Block diagram of the hardware system of the fluid conditioning system.

[0063] Fig.25 Provided Figure 1 Block diagram of the software system of the fluid conditioning system.

[0064] Fig.26 is a perspective view of an actuation system designed to control multiple valves of a cassette within a dialysis system.

[0065] Fig. 27 yes Fig.26 A top view of the actuation system showing a first configuration of the positioning frame.

[0066] Fig.28 yes Fig.26 0026] Figure 2 is a top view of the actuation system showing a second configuration of the positioning frame.

[0067] Fig.29 yes Fig.26 A top view of the actuation system showing a first configuration of the positioning frame.

[0068] Fig.30 yes Fig.26 Exploded perspective view of the actuation system.

[0069] Fig.31 It can be done by Fig.26 An enlarged perspective view of a valve controlled by an actuation system.

[0070] Fig.32 It can be done by Fig.26 A perspective view of a valve controlled by an actuation system.

[0071] Fig.33 yes Fig.32 Exploded perspective view of the valve.

[0072] Fig.34 It includes Fig.26 A top perspective view of a cassette of multiple valves controlled by an actuation system.

[0073] Fig.35 yes Fig.34 Bottom perspective view of the box.

[0074] Fig.36 is a perspective view of a valve drive assembly with the outer sleeve omitted to show certain internal components.

[0075] Fig.37 yes Fig.36 A perspective view of a valve drive assembly including an outer sleeve.

[0076] Fig.38 yes Fig.36 A perspective cutaway view of a valve drive assembly.

[0077] Fig.39 yes Fig.36 A perspective cut-away view of a portion of a valve drive assembly.

[0078] Fig.40 yes Fig.36 A perspective view of the floating x / y motor drive assembly of the valve drive assembly.

[0079] Fig.41 yes Fig.36 A perspective view of the floating z-motor drive assembly of the valve drive assembly.

[0080] Fig.42 yes Fig.26 A top view of a cassette including tubes arranged to interface with multiple pumps of a dialysis system and with certain features omitted. DETAILED DESCRIPTION

[0081] Figure 1-4 A fluid conditioning system 100 is shown that can be operated to prepare conditioned dialysate for a dialysis system. For example, the fluid conditioning system 100 can be fluidly connected to the dialysis system to deliver "fresh" (e.g., purified, conditioned) dialysate to the dialysis system, collect "spent" (e.g., contaminated, unconditioned) dialysate from the dialysis system, and regenerate (e.g., purify) and condition spent dialysate in a continuous fluid flow loop to recover spent dialysate. Example dialysis systems with which the fluid conditioning system 100 can be fluidly connected include hemodialysis (HD) systems, peritoneal dialysis (PD) systems, hemofiltration (HF), hemodiafiltration (HDF), and other related systems.

[0082] The fluid conditioning system 100 includes: a housing 101 that contains or supports the components of the fluid conditioning system 100; a fluid box 102 that includes a plurality of fluid lines that define various fluid paths; two relatively high-capacity pumps 103 that can circulate fluid within the fluid lines of the fluid box 102; and two relatively low-capacity pumps 104 that can deliver (e.g., infuse) a conditioning agent into the fluid circulating within the fluid lines of the fluid box 102. The fluid conditioning system 100 has a compact footprint that facilitates lifting and transporting the fluid conditioning system 100. For example, the fluid conditioning system 100 typically has a length of about 30 cm to about 50 cm, a width of about 30 cm to about 50 cm, a height of about 30 cm to about 50 cm, and a weight of about 15 kg to about 20 kg.

[0083] The housing 101 includes left and right side panels 105, 106, a handle 107 positioned along the side panels 105, 106 for carrying the fluid conditioning system 100, a door assembly 108 that can be opened and closed to insert a heater bag, a front panel 109 to which the door assembly 108 is secured, a rear panel 110 and a bottom panel 111 that further enclose the internal components, an upper panel 112 that supports the fluid cartridge 102 and the pumps 103, 104, and a cover 113 that protects the fluid cartridge 102 and the pumps 103, 104. Example materials from which the exterior panels of the housing 101 may be made include plastics, such as acrylonitrile butadiene styrene (ABS) and polycarbonate blends, among others.

[0084] The cover 113 is typically made of ABS or polycarbonate and is transparent or translucent to allow visual observation of the fluid cartridge 102 and pumps 103, 104. The cover 113 can be pivoted at a rear hinge 114 provided along the upper panel 112 to open or close the cover 113. The upper panel 112 carries two latches 115 that can be closed on the front edge 116 of the cover 113 to secure the cover 113 in the closed position. The latches 115 can also be pulled up and separated from the cover 113 to release the cover 113 from the closed position to access the fluid cartridge 102 and pumps 103, 104.

[0085] refer to Figure 5 , the fluid conditioning system 100 also includes left and right internal support frames 117, 118 to which the left, right, front, rear, bottom and upper panels 105, 106, 109, 110, 111, 112 are attached. The internal support frames 117, 118 are typically formed from sheet metal.

[0086] Each pump 103, 104 is a peristaltic pump that includes a plurality of rollers positioned around the circumference of a rotatable frame (e.g., a motor) that carries fluid lines extending from the fluid cartridge 102. As the rotatable frame rotates, the rolling members apply pressure to the fluid lines, thereby forcing fluid to flow through the fluid lines.

[0087] Figure 6-8 100. For example, the fluid conditioning system 100 also includes a plurality of pressure transducers 119, two temperature sensors 120, and an ammonia detector 121, each located in holes 122, 123, 124 in the upper panel 112 for engaging with the fluid cartridge 102. The pressure transducer 119 is implemented to contact the fluid cartridge 102 (see Fig.15 ) is used to detect fluid pressure within certain fluid paths of the fluid cassette 102. The temperature sensor 120 is an infrared (IR) sensor that detects the temperature of the dialysate flowing through certain points of the fluid paths of the fluid cassette 102. The ammonia detector 121 is a red-green-blue (RGB) color sensor that can detect color changes on a paper strip within the fluid cassette 102 to determine the concentration of ammonium (e.g., which produces ammonia) in the dialysate flowing through a certain fluid path of the fluid cassette 102. The fluid conditioning system 100 also includes circuitry for acquiring and conditioning signals generated by a conductivity sensor provided on the fluid cassette 102, which will be discussed in more detail below.

[0088] The fluid conditioning system 100 also includes a plurality of actuators 125 aligned with holes 126 in the upper panel 112 for individually and selectively moving a plurality of valves of the fluid cartridge 102. Each actuator 125 is mounted to a platform 127 of an internal frame 128 of the fluid conditioning system 100 and includes a motor 129 and a drive unit 130 that can be moved (e.g., rotated or otherwise manipulated) by the motor 129. The drive unit 130 is provided with a coupling member 131 formed to engage a corresponding valve of the fluid cartridge 102 such that movement of the drive unit 130 causes movement of the valve. The internal frame 128 also includes a columnar support member 132 that supports and positions the upper panel 112 of the housing 101. The upper panel 112 also defines holes 133 that are positioned and sized to receive locating pins 134 for properly positioning the fluid cartridge 102 relative to the upper panel 112. With the fluid cartridge 102 in place, the locating pins 134 can be snapped down onto the upper panel 112 to lock the position of the fluid cartridge 102. The fluid conditioning system 100 also includes a circuit board 135 that is equipped with electronics for operating the various electromechanical components of the fluid conditioning system 100. For example, the electronics perform various stages for performing a fluid conditioning cycle (as described below with reference to Figure 18-20104, controls valves for the fluid cassette 102, processes sensor signals, operates the actuator 125, operates the heater assembly 151, and runs control loops (e.g., control loops for regulating dialysate temperature, regulating pump speed to achieve a desired flow rate, regulating pump speed to achieve a desired dialysate chemistry, and ensuring device safety).

[0089] Reference again Figure 5 The fluid conditioning system 100 also includes a support bracket 136 and a fan 137 carried in the support bracket 136 for cooling the circuit board 135 and other internal components of the fluid conditioning system 100. The fluid conditioning system 100 also includes a power source 138 and a support bracket 139 carrying an A / C input port 140.

[0090] Figure 9-13 Various views of a front assembly 141 of the fluid conditioning system 100 are shown. The front assembly 141 includes a door assembly 108 and a front panel 109 of the housing 101. The door assembly 108 is pivotable relative to the front panel 109 at hinges 142 to allow a heater bag 153 to be loaded into the fluid conditioning system 100. The hinges 142 are friction hinges disposed along opposite sides of the door assembly 108, such as Fig.12 shown.

[0091] The front panel 109 carries a latch assembly 143, which is connected to the upper panel 112 ( Figure 1-4 108 to the front panel 109 in the closed position. For example, depression of the button 144 adjusts the latch assembly 143 so that the door assembly 108 can be unlocked and pivoted from the closed position to the open position. Alternatively, the door assembly 108 can be pivoted inwardly from the open configuration until an oppositely positioned screw 145 (e.g., Fig.12 The shoulder screw shown in FIG. 1 engages the latch assembly 131 to lock the door assembly 108 in the closed position. The latch assembly 131 has a contact switch for determining whether the door assembly 108 is open or closed. Fig.11 and 13 , the door assembly 108 includes an optical switch 147 that indicates whether a heater bag is inserted. In some embodiments, the fluid conditioning system 100 may not be operable when the door assembly 108 is open.

[0092] Special References Fig. 9, the door assembly 108 supports a display screen 148 (e.g., a touch screen display) on which a graphical user interface (GUI) can be displayed and two control panels 149 that can be each equipped with a selector 150 (e.g., a button) for providing input at the GUI to operate the fluid conditioning system 100. Example parameters and processes that can be controlled by the user via the display screen 148 using the selectors 150 include starting and stopping treatment, initiating a drain cycle, changing flow rates, initiating the priming phase of a fluid conditioning cycle, initiating system preparation to begin a fluid conditioning cycle, adjusting the temperature based on patient comfort, confirming proper placement of the fluid cartridge 102, or confirming proper placement of fluid lines interfaced with the pumps 103, 104.

[0093] refer to Figure 10-13 , the front assembly 141 includes components of a heater assembly 151 designed to regulate the fluid temperature of the dialysate transported along the fluid path of the fluid cassette 102. With particular reference to Fig.12 , the heater assembly 151 includes a heater bag 153 equipped with an input connection structure 154 and an output connection structure 155, which can interface with the fluid box 102 to allow the dialysate to be warmed by circulating through the heater bag 153. The heater bag 153 is formed as a plastic channel that has a generally flat collapsed shape when empty, expands when filled with fluid, and transfers heat from the external surface to the dialysate flowing through the heater bag 153.

[0094] Special References Fig.13 The heater assembly 151 also includes two plates 156 (eg, aluminum plates) that position and support the heater bag 153 and are heated to transfer heat to the fluid within the heater bag 153. Fig.14 When the door assembly 108 is in the open configuration, the heater bag 153 can be placed between two heater plates 156 (in Fig.14 ). Figure 10-12 The heater assembly 151 also includes one or more heating elements (e.g., resistive heating elements not shown) by which the fluid in the heater bag 153 can be warmed, and the heater assembly 151 also includes two insulating pads 158 disposed on opposite sides of the heater bag 153. The one or more heating elements are carried by one or both of the two boards or otherwise attached to one or both of the two boards. The heater assembly 151 also includes a circuit board 159 that provides electronics for operating the heater assembly 151, a feed line 160 for each heating pad 156 for providing power, and a thermocouple connection structure 162 for determining the temperature of the corresponding heating plate 156.

[0095] Fig.15 and 16 Another embodiment of a heater assembly 170 that may be included in the fluid conditioning system 100 instead of the heater assembly 151 is shown. The heater assembly 170 is similar in construction and function to the heater assembly 151 and thus includes a heater bag 153 sandwiched between two heater plates 156. The heater assembly 170 also includes two handles 171 attached to the heater bag 153 to facilitate placement of the heater bag 153; a u-shaped heater frame 172 that supports the heater bag 153; and two support members 173 that support the generally matrix structure of the heater plates 156. The support members 173 also serve to isolate the heater bag 153 and the heater plates 156 from surrounding components via an air gap 174 that is provided between the heater plates 156 and such surrounding components and defined by the matrix structure.

[0096] refer to Fig.17 The fluid box 102 is a single-use disposable cassette that includes a housing 200, a plurality of fluid lines 201 disposed within the housing 200, a plurality of valves 202 positioned along the fluid lines 201, two conductivity sensors 203 positioned along the fluid lines 201, an ammonia sensor 165 positioned along the fluid lines 201 for cooperating with the ammonia detector 121, two fluid line connectors (e.g., pump segment clamps) 204, and two fluid line connectors (e.g., pump segment clamps) 205. The fluid lines 201 cooperate with the heater bag 153 and the dialysis system to form a fluid circuit 350 for performing a fluid conditioning cycle. For example, the fluid lines 201 include ports to which the input and output connection structures 154, 155 of the heater bag 153 can be connected to provide fluid communication between the fluid lines 201 and the heater bag 153. Fluid line connector 204 positions fluid line segment 206 around high capacity pump 103, while fluid line connector 205 positions fluid line segment 207 around low capacity pump 104. Fig.19 As shown, the fluid box 102 also includes additional fluid lines extending from the fluid box 102 to various fluid containers.

[0097] The valve 202 is a three-way valve by which two alternative fluid paths can be selected by the control system of the fluid conditioning system 100. The lower portion of the valve 202 is formed to engage with the coupling member 131 of the actuator 125 for movement of the valve 202. Example types of valves 202 that may be included in the fluid cartridge 102 include rotary valves, push-pull valves, slide valves, and shuttle valves.

[0098] Fig.18 An operational diagram 300 is shown by which the fluid conditioning system 100 may cooperate with a dialyzer 337 of a dialysis system 301 to form a fluid circuit 350 (represented by a solid line) for performing a fluid conditioning cycle, while Fig.19 An example arrangement of a fluid conditioning system 100 with a dialysis system 301 is shown. Example types of dialysis systems 301 that may be coupled to the fluid conditioning system 100 include HD systems, PD systems, HF systems, and HDF systems. The fluid circuit 350 contains components of the fluid cassette 102 and various other components of the fluid conditioning system 100.

[0099] For example, in addition to the above combination Figure 1-17 In addition to the components discussed, the fluid conditioning system 100 also includes a control system 161 (e.g., including circuit boards 135, 159 and additional circuit boards for sensor circuits) for controlling various operations of the fluid conditioning system 100 and other multiple peripheral components positioned along the fluid circuit 350. These components include a perfusion tank 302 for collecting water to produce a dialysate (e.g., sometimes referred to as a dialysis fluid), a sorbent cartridge 303 for filtering tap water to provide purified water suitable for producing a dialysate and for purifying the dialysate exiting the dialysis system 301, a primary reservoir 304 for collecting fluid (e.g., unconditioned water or dialysate) exiting the sorbent cartridge 303, a secondary reservoir 305 for collecting fluid exceeding the capacity of the primary reservoir 304, a bag 306 for holding an electrolyte solution, a bag 307 for holding a salt-dextrose (SD) solution, a bag 308 for holding a dilution water (DW), and a bag 309 for holding a bicarbonate (BC) solution, which are positioned along the fluid flow path configuration structure 300.

[0100] The bags 306, 307, 309 are pre-filled with appropriate amounts of dry chemicals that can be dissolved in water to produce electrolyte solutions, saline-glucose solutions, and bicarbonate solutions. Each bag 306, 307, 309 includes a nozzle designed to increase the velocity of the fluid flow entering the bag 306, 307, 309 and to generate the turbulence required to fully mix and dissolve the dry chemicals in the water.

[0101] Table 1 lists the approximate capacities of the various fluid-containing components of the fluid conditioning system 100.

[0102] part Capacity(mL) Filling tank(302) 8,000 Main storage (304) 7,500 From storage (305) 4,500 Electrolyte Bags(306) 500 Salt / Glucose Bags(307) 160 Dilution water bag(308) 4,000 Bicarbonate Bags(309) 1,000

[0103] Table 1: Capacities of Fluid-Containing Components of Fluid Conditioning System 100

[0104] The three-way valves 202 of the fluid box 102 are labeled V1-V7 in the fluid circuit 350. Each valve includes three fluid ports (a), (b), (c), through which the flow path in the valve can be adjusted. When two or three of the ports of the valve are closed, the valve can be referred to as closed, and when two or three of the ports of the valve are opened, the valve can be referred to as open. These valves include a perfusion valve V1, a dissolution valve V2, a bypass outflow valve V3, a bypass inflow valve V4, a BC / DW valve V5, a S / D / electrolyte valve V6, and a fluid selector valve V7. The fluid lines 201 of the fluid box 102 will be further cited separately below in conjunction with the operation of the fluid conditioning system 100. The high-capacity pump 103 and the low-capacity pump 104 of the fluid conditioning system 100 are labeled P1, P2 and P3, P4, respectively, in the fluid circuit 350. These pumps include cassette inflow pump P1 , dialysate pump P2, conductivity control pump P3, and electrolyte / salt-glucose pump P4. Table 2 lists the approximate operating ranges (eg, fluid flow rates) of pumps P1-P4.

[0105] Pump Operating range (mL / min) P1 20–600 P2 20–600 P3 0.5–90 P4 0.5–90

[0106] Table 2: Operating Ranges of the Pumps of the Fluid Conditioning System 100

[0107] The heater assembly 151 and the ammonia sensor 165 of the fluid conditioning system 100 are labeled as heat exchanger HX and ammonia sensor NH, respectively, in the fluid circuit 350. The conductivity sensors 203 of the fluid box 102 are labeled as conductivity sensor CT1 associated with the fluid temperature upstream of the heat exchanger HX and conductivity sensor CT2 associated with the fluid temperature downstream of the heat exchanger HX. In addition to having the ability to measure fluid conductivity, the conductivity sensors CT1 and CT2 also have the ability to measure fluid temperature. Given that conductivity varies with temperature, in some embodiments, the temperature measured by the conductivity sensors CT1 and CT2 can be used to correct the conductivity values ​​measured by the conductivity sensors CT1 and CT2 to provide temperature compensated conductivity measurements. In some embodiments, the fluid temperature measured by the conductivity sensor CT2 can also provide a safety check on the final temperature of the dialysate leaving the fluid conditioning system 100 to flow into the dialysis system 303. The temperature sensors 120 of the fluid conditioning system 100 are labeled in the fluid circuit 350 as cartridge inlet temperature sensor T1 and heat exchanger temperature sensor T2. The pressure transducers 119 of the fluid conditioning system 100 are labeled in the fluid circuit 350 as pressure transducers PT1, PT2, PT3, and PT4.

[0108] The fluid conditioning system 100 can operate in multiple phases in cooperation with the dialysis system 301 (e.g., with the dialyzer 337) to perform a fluid conditioning cycle in which a dialysis treatment is administered to a patient via the dialysis system 301. For example, a fluid conditioning cycle includes a perfusion phase, an infusion phase, and a treatment phase. A fluid conditioning cycle typically has a total duration of about 135 minutes to about 300 minutes.

[0109] Fig. 20 1 shows the operation of the fluid conditioning system 100 during a priming phase, wherein an initial volume of water is drawn into the fluid circuit 350 for subsequent production of dialysate. At the beginning of the priming phase, the priming tank 302 is filled with water from a water source (e.g., a container 134 of water, such as Fig.19 The priming tank 302 is filled with water (e.g., tap water, bottled water, reverse osmosis water, distilled water, or drinking water) to about 7.6 L, the pump P1 is activated, and the heat exchanger HX is activated. Water is pumped from the priming tank 302 into the fluid line 310 by the pump P1, pumped into the fluid line 311 through ports (a) and (c) of the valve V1, passes through the temperature sensor T1, and then enters the pump P1. In this stage of operation, the pump P1 pumps water at a flow rate in the range of about 200 mL / min to about 600 mL / min, and powers the heat exchanger HX to maintain the fluid temperature at a set point in the range of about 15° C. to about 42° C.

[0110] If the temperature sensor T1 detects that the water temperature is above about 42° C., a message is displayed on the display screen 148 to inform the user that the water temperature is too hot, the valve V1 is closed, and the pump P1 is turned off to prevent additional water from entering the fluid circuit 350. If the temperature sensor T1 detects that the water temperature is less than or equal to about 42° C., ports (a) and (c) of the valve V1 remain open, and the pump P1 pumps water into the sorbent cartridge 303 through the fluid line 312, then into the fluid line 313, through the ammonia sensor NH, and then into the main reservoir 304. In this stage of operation, the sorbent cartridge 303 purifies the water circulating in the fluid circuit 350 so that the water meets or exceeds the drinking water quality standards established by the Environmental Protection Agency (EPA) and the hemodialysis water quality standards established by the Association for the Advancement of Medical Instrumentation (AAMI) standards.

[0111] Once the primary reservoir 304 has collected about 100 mL to about 500 mL of water, pump P2 is activated and pumped by pump P2 into fluid line 314, then into fluid line 315, through conductivity sensor CT1, and through heat exchanger HX1, which heats the water in fluid line 315 to a set point temperature. Pump P2 is controlled to pump water at a flow rate approximately equal to the flow rate at which pump P1 pumps water. Water moves from fluid line 315 through ports (c) and (a) of valve V2 to fluid line 316, through ports (b) and (a) of valve V7, into fluid line 317, through ports (c) and (a) of valve V5 into fluid line 318, and further into bag 308 until bag 308 is filled with water (e.g., dilution water) to about 3.5 L to about 4.0 L.

[0112] Next, close ports (a) and (c) of valve V5, close port (a) of valve V7, open port (c) of valve V7, so that pump P2 pumps water into fluid line 319 through ports (c) and (a) of valve V6, then into fluid line 320, and then further pumps into bag 306 until bag 306 is full of water to produce an electrolyte solution. Close ports (a) and (c) of valve V6, close port (c) of valve V7, reopen port (a) of valve V7, and open ports (b) and (c) of valve V5. Then, pump P2 pumps water into fluid line 317 through ports (c) and (b) of valve V5, then into fluid line 321, and then further pumps into bag 309 until bag 309 is full of water to produce a bicarbonate solution.

[0113] At this point in the priming phase, the set point temperature of heat exchanger HX is increased to a range of about 31° C. to about 39° C. (e.g., where 39° C. is the maximum temperature that heat exchanger HX can reach), and the flow rate of pump P2 is reduced to a value in the range of about 100 mL / min to about 300 mL / min to increase the exposure time of the water within heat exchanger HX to achieve a higher set point temperature. Ports (b) and (c) of valve V5 are closed, port (a) of valve V7 is closed, port (c) of valve V7 is opened, and ports (b) and (c) of valve V6 are opened. Thus, pump P2 pumps water through ports (c) and (b) of valve V6 into fluid line 319, then into fluid line 322, and further into bag 307 until bag 307 is full to produce a saline-glucose solution. The higher set point temperature of heat exchanger HX promotes the dissolution of the saline-glucose substance by the water flowing into bag 309. At this point during the fluid conditioning cycle, the priming phase is complete, the priming tank 302 has been substantially emptied, pumps P1, P2 are turned off, and the infusion phase begins. The priming phase typically lasts for a duration of about 10 minutes to about 30 minutes (eg, about 20 minutes).

[0114] Fig.21 Operation of the fluid conditioning system 100 is shown during an infusion phase, in which bicarbonate, saline, and glucose are added to water in the fluid circuit 350 to produce a dialysate. In particular, bicarbonate, saline, and glucose are added to the water in a controlled manner (e.g., under flow rate control) until the saline and glucose reach physiologically acceptable concentrations and until the bicarbonate produces a physiologically acceptable fluid conductivity and fluid pH. During the infusion phase, the heat exchanger HX is powered to maintain the fluid temperature at a set point in the range of about 35° C. to about 39° C.

[0115] At the beginning of the infusion phase, valve V7 is closed, port (a) of valve V2 is closed, port (b) of valve V2 is opened, ports (a) and (b) of valves V3 and V4 are opened, port (b) of valve V1 is opened, port (a) of valve V1 is closed, ports (b) and (c) of valve V6 remain open, and ports (b) and (c) of valve V5 are opened. Pumps P1 and P2 are immediately activated to pump water at a flow rate of about 300 mL / min to about 600 mL / min in fluid circuit 350. At the same time, pumps P3 and P4 are turned on. Pump P3 pumps bicarbonate solution out of bag 309 at a flow rate of about 10 mL / min to about 100 mL / min, pumps it into fluid line 317, through pump P3, and then pumps it into fluid line 314. Pump P4 pumps the salt-glucose solution out of bag 307 at a variable flow rate, pumps it into fluid line 319, passes through pump P4, and then pumps it into fluid line 314. The flow rate of the initial pumping fluid of P4 is in the range of about 1 mL / min to about 100 mL / min. The flow rate gradually decreases at a rate of 1 / 2 decrease in periodic time increments of about 1 min. The flow rates of pumps P3 and P4 are set to completely add the infusion volume of BC solution and SD solution respectively on a single turn around the fluid circuit 350. Therefore, the flow rates of pumps P3 and P4 are related to the flow rates of pumps P1 and P2 during the infusion phase. For example, if the flow rates of pumps P1 and P2 are set to 200 mL / min, the flow rates of pumps P3 and P4 will be relatively slow. On the contrary, if the flow rates of pumps P1 and P2 are set to 600 mL / min, the flow rates of pumps P3 and P4 will be relatively fast.

[0116] Once bag 307 is emptied of the saline-glucose solution, port (b) of valve V6 is closed and port (a) of valve V6 is opened to allow pump P4 to pump electrolyte solution from bag 306 into fluid line 314 at a flow rate of about 0.5 mL / min to about 5 mL / min. Once the electrolyte solution reaches valve V3, the infusion phase is over and the treatment phase can begin. However, if the treatment phase is not immediately initiated, the fluid conditioning system 100 can be operated to continue circulating the dialysate around the fluid circuit 350 through fluid lines 311, 312, 313, 314, 315, 323, 336, 326, or to allow the dialysate to remain static (e.g., not circulated) until the treatment phase begins. The infusion phase typically lasts for a duration of about 5 minutes to about 6 minutes.

[0117] Fig. 22 Operation of the fluid conditioning system 100 is shown during a treatment phase in which bicarbonate, saline, and glucose are added to water in the fluid circuit 350 to produce a dialysate. The treatment phase includes a first phase in which bicarbonate solution is used to adjust the conductivity of the dialysate and a second phase in which dilution water is used to adjust the conductivity of the dialysate. Pumps P1, P2 pump the dialysate at a flow rate in the range of about 200 mL / min to about 600 mL / min. The set point temperature of the heat exchanger HX is maintained at a physiologically acceptable temperature within an acceptable range of about 35°C to about 39°C (e.g., about 37°C), which can be specifically selected by a user of the fluid conditioning system 100 to provide comfort to the patient. At any time during a treatment session, if the dialysate fluid temperature measured at CT2 is outside the range of about 35° C. to about 42° C., the fluid conditioning system 100 will enter a bypass mode in which dialysate will flow through fluid line 336 to bypass the dialysis system 301 via fluid lines 324, 325. While the fluid conditioning system 100 is operating in bypass mode, a message indicating that the fluid temperature is too low or too high will be displayed on the display screen 148. The fluid conditioning system 100 will remain in bypass mode until the fluid temperature stabilizes within an acceptable range.

[0118] During the first phase of the treatment phase, port (b) of valve V3 is closed, port (c) of valve V3 is opened to allow pump P2 to pump "fresh" dialysate (e.g., purified, conditioned dialysate) through fluid line 324 and into dialysis system 301, port (a) of valve V4 is closed, port (c) of valve V4 is opened to allow pump P1 to pump "spent" dialysate (e.g., contaminated dialysate) out of dialysis system 301 through fluid line 325 and further into fluid line 326. Thus, bypass fluid line 336 extending between valves V3, V4 is closed. During the treatment phase, the spent dialysate is infused with ultrafiltrate from the patient's blood within dialysis system 301. The ultrafiltrate carries with it toxic substances such as urea, all small water-soluble uremic toxins, and other toxic substances (e.g., guanidinosuccinic acid, methylguanidine, 1-methyladenosine, 1-methylinosine, N2, N2-dimethylguanosine, pseudouridine, arabinitol, mannitol, α-N-acetylarginine, orotidine, oxalate, guanidine, erythritol, creatine, orotic acid, phenylacetylglutamine, creatinine, inositol, γ-guanidinobutyric acid, β-guanidinopropionic acid, symmetric dimethylarginine (SDMA), asymmetric dimethylarginine (ADMA), sorbitol, uridine, and xanthine).

[0119] The spent dialysate is pumped from fluid line 326 through ports (b) and (c) of valve V1, fluid line 311, pump P1, fluid line 312, and then into sorbent cartridge 303. Within sorbent cartridge 303, toxic substances are removed (e.g., filtered out) from the spent dialysate to produce a "regenerated" dialysate (e.g., purified, but unconditioned dialysate) that flows out of sorbent cartridge 303 and into fluid line 313, through ammonia sensor NH, and into primary reservoir 304. In some cases, the volume of regenerated dialysate within primary reservoir 304 exceeds the capacity of primary reservoir 304 and thus flows through fluid line 327 to slave reservoir 305, which remains in fluid communication with primary reservoir 304 throughout the treatment phase. Pump P2 pumps the regenerated dialysate out of primary reservoir 304, into fluid line 314, and into pump P2. Although the regenerated dialysate exiting the sorbent cartridge 303 has removed toxic substances absorbed from the patient's blood in the dialysis system 301, the regenerated dialysate must be further conditioned to meet acceptable physiological properties before being circulated back into the dialyzer 337 of the dialysis system 301 as fresh dialysate.

[0120] Thus, pump P4 continues to pump electrolyte solution from bag 306 at a flow rate related to (e.g., a fraction of) the flow rate at which pump P2 pumps dialysate, and pumps it into fluid line 320, through ports (a) and (c) of valve V6, into the upper section of fluid line 319, through pump P4, and into fluid line 314. Thus, pumps P2 and P4 together form a closed-loop pump control circuit 332 that controls the flow rate at which pump P4 pumps electrolyte solution, which is in the range of about 0.5 mL / min to about 5 mL / min. In addition, pump P3 continues to either pump bicarbonate solution from bag 309 or dilution water from bag 308, through port (c) of valve V5, into the upper section of fluid line 317, through pump P3, and into fluid line 314 to further condition the dialysate.

[0121] As the dialysate passes through pump P2 and conductivity sensor CT1, conductivity sensor CT1 detects the conductivity of the dialysate. Based on the continuous measurement of the conductivity of the dialysate, either bicarbonate solution or dilution water is continuously selected to be added to the dialysate through port (c) of valve V5, and the flow rate of the dialysate pumped by pump P3 is continuously adjusted to maintain the conductivity of the dialysate within a physiologically acceptable range of 13.5 mS / cm to 14.2 mS / cm. Typically, as the difference between the measured conductivity and the acceptable conductivity increases, the flow rate of the fluid pumped by pump P3 increases. Therefore, as the difference between the measured conductivity and the acceptable conductivity decreases, the flow rate of the fluid pumped by pump P3 decreases. In this way, the conductivity meter CT1 and pump P3 together form a closed-loop pump control loop 331 that regulates the flow rate of the fluid pumped by pump P3. If the conductivity of the dialysate is too low during the first phase of the treatment phase, bicarbonate solution is infused into the dialysate to increase the conductivity.

[0122] After passing through the conductivity sensor CT1, the dialysate flows through the heat exchanger HX and the temperature sensor T2. Based on the fluid temperature detected by the temperature sensor T2, the power level of the heat exchanger HX is adjusted to maintain the temperature of the dialysate at the set point temperature of the heat exchanger HX. In this way, the temperature sensor T2 and the heat exchanger HX form a closed-loop heater control loop 333. The dialysate flows from the fluid line 315 into the fluid line 323 through the ports (c) and (b) of the valve V2 and passes through the conductivity sensor CT2. When the dialysate passes through the conductivity sensor CT2, the conductivity sensor CT2 performs a second check (e.g., downstream of the heat exchanger HX) to detect the conductivity of the dialysate.

[0123] If the conductivity of the dialysate is outside the acceptable range (e.g., too low or too high) but within a predetermined range (e.g., a range wider than the acceptable range), the safety system in electrical communication with the conductivity sensor will adjust the infusion flow rate of the bicarbonate solution or dilution water to achieve a conductivity within the acceptable range. If the conductivity level of the dialysate is outside the predetermined physiological safety range, in some embodiments, the fluid conditioning system 100 will attempt to restore safe fluid parameters and continue treatment. For example, valves V3 and V4 will adjust to direct fluid through the bypass fluid line 336 and close the fluid lines 324, 325 until the conductivity stably reaches the physiological safety range again, at which time valves V3, V4 will adjust to close the bypass fluid line 336 and direct fluid to and from the dialysis system 301 via the fluid lines 324, 325. In some embodiments, the user may also be instructed to check that the fluid levels of the bicarbonate solution and dilution water are non-zero when restoring the conductivity to a physiologically safe range.

[0124] Over time, the sorbent cartridge 303 changes the composition of the regenerated dialysate leaving the sorbent cartridge 303 during the first phase of the treatment phase (e.g., during the early initial phase when the patient's blood is initially circulated through the dialysis machine 301). For example, during the first phase of the treatment phase, the level of toxic substances in the spent dialysate is relatively high. The sorbent cartridge 303 converts urea into ammonium and captures the ammonium in one or more filter layers within the sorbent cartridge 303 to remove ammonium from the dialysate. While the filter layers capture ammonium, the filter layers release sodium cations and other cations into the dialysate via cation exchange, which increases the conductivity and / or lowers the pH of the regenerated dialysate leaving the sorbent cartridge 303.

[0125] During the first phase of the treatment phase, the spent dialysate entering the sorbent cartridge 303 contains less toxic substances (e.g., removed from the patient's blood as uremic toxins), and the sorbent cartridge 303 releases more sodium ions. As a result, the conductivity of the dialysate leaving the sorbent cartridge 303 gradually increases over time. Once the conductivity of the dialysate reaches a predetermined value in the range of about 13.8 mS / cm to about 14.0 mS / cm, the first phase of the treatment phase of using bicarbonate to adjust the conductivity of the dialysate ends, and the second phase of the treatment phase begins.

[0126] In the second phase of the treatment phase (e.g., the final phase later), bicarbonate is no longer used to adjust (e.g., increase) the conductivity of the dialysate, and dilution water is the only substance used at valve V5 to adjust (e.g., reduce) the conductivity of the dialysate until the end of the treatment phase (e.g., the end of the second phase). Therefore, port (b) of valve V5 is closed, and port (a) of valve V5 is opened. If the conductivity of the dialysate is too high during the second phase of the treatment phase, dilution water is infused into the dialysate to reduce the conductivity of the dialysate.

[0127] During the second phase of the treatment phase, the amount of ammonium captured in the sorbent cartridge 303 increases, causing the ability of the sorbent cartridge 303 to absorb additional ammonium to gradually decrease, and once the sorbent's capacity to absorb ammonium is exhausted, the level of ammonia (e.g., generated by ammonium) in the regenerated dialysate eventually increases. An ammonia sensor NH detects the level of ammonia in the regenerated dialysate at a location downstream of the sorbent cartridge 303.

[0128] The treatment phase (e.g., including both the first phase and the second phase) typically lasts for a duration of about 120 min to about 300 min. For example, 240 min (e.g., 4 hours) is a standard duration that typically achieves adequate treatment for the vast majority of patients. In addition, most treatment phases will end after four hours without reaching the threshold ammonium concentration of 2 mg / dL (e.g., never approaching exhaustion of the filtration capacity of the sorbent cartridge 303). The fluid conditioning system 100 will sound an audio alarm indicating that the treatment has been successfully completed and the patient can disconnect him or herself from the dialyzer 337. However, if the ammonium level in the dialysate (e.g., detected by the ammonia sensor NH) indicates that the sorbent cartridge 303 is no longer absorbing enough ammonium from the spent dialysate to maintain the ammonium level at or below an acceptable value of about 2 mg / dL before the standard treatment duration, then the treatment phase will end prematurely. This situation occasionally occurs for larger patients with very high blood urea nitrogen (BUN) levels.

[0129] Once the treatment phase is over, the spent dialysate in the fluid circuit 350 can be drained and disposed of as waste. In some examples, bags 306, 307, 308, 309 and various fluid lines can be manually removed and discarded while still containing dialysate. In some examples, the patient can disconnect from the dialysis system 301 and drain the fluid lines 323, 326 to the waste reservoir to drain the various components of the fluid conditioning system 100. In some examples, the fluid conditioning system 100 can be operated to run either or both of the pumps P1, P2 in forward or reverse direction to drain any of the bags 306, 307, 308, 309, the sorbent cartridge 303, the perfusion tank 302, the master reservoir 304, and the slave reservoir 305. In some examples, the fluid conditioning system 100 can be operated to run pumps P4 and P3 in forward direction to drain bags 306, 307 and 308, 309. In some examples, such operation of pumps P4, P3 may be performed based on the reading of conductivity meter CT1. For example, upon detection of a sufficiently low threshold conductivity, it may be assumed that electrolyte bag 306 has been drained so that the next bag or fluid line may be drained.

[0130] Throughout the fluid conditioning cycle, pressure transducers PT1, PT2, PT3, PT4 detect fluid pressure to adjust the pump flow rate. For example, during all stages of the fluid conditioning cycle (e.g., perfusion, infusion, and treatment stages), pressure transducer PT1 forms a closed-loop pump control loop 328 with pump P1 by detecting the fluid pressure of the dialysate in fluid line 312 (e.g., downstream of pump P1) and providing a feedback signal indicating the fluid pressure to pump P1. Based on the fluid pressure of the dialysate, the angular velocity (e.g., RPM level) of pump P1 is adjusted to maintain the flow rate within a desired range. During the treatment stage of the fluid conditioning cycle, pressure transducer PT4 forms an additional closed-loop pump control loop 329 with pump P1 by detecting the fluid pressure of the dialysate leaving the dialysis system 301 (e.g., upstream of pump P1) and providing a positive signal indicating the fluid pressure to pump P1. Based on the fluid pressure of the dialysate, the angular velocity of pump P1 is adjusted to closely match the flow rate at pump P1 with the flow rate of dialysate exiting the dialysis system 301. Thus, the fluid pressure of the dialysate within fluid line 312 (e.g., upstream of pump P1) is at least partially affected by the fluid pressure of the dialysate exiting the dialysis system 301 (e.g., upstream of pump P1).

[0131] Similarly, during all phases of the fluid conditioning cycle (e.g., perfusion, infusion, and treatment phases), the pressure transducer PT2 forms a closed-loop pump control loop 330 with the pump P2 by detecting the fluid pressure of the dialysate within the fluid line 315 (e.g., downstream of the pump P2) and providing a feedback signal indicative of the fluid pressure to the pump P2. Based on the fluid pressure of the dialysate, the angular velocity of the pump P2 is adjusted to maintain the flow rate within a desired range. As described above, during the treatment phase of the fluid conditioning cycle, the flow rate at which the pump P3 pumps the fluid is regulated by the feedback signal from the conductivity meter CT1 to form a pump control loop 331, while the flow rate at which the pump P4 pumps the electrolyte solution is regulated by the feedback signal from the pump P2 to form a pump control loop 332.

[0132] During all phases of the fluid conditioning cycle, pressure transducers PT3 and PT4 monitor the operation of the dialyzer 337. If the measurements of pressure transducers PT3 and PT4 indicate that no fluid is flowing through the dialyzer 337, the fluid conditioning system 100 will enter a bypass mode to allow dialysate to flow through fluid line 336 and avoid delivering dialysate to the dialysis system 301 via fluid lines 324, 325.

[0133] Fig.23 A block diagram of a control system 161 is provided. The control system 161 includes a processor 410, a memory 420, a storage device 430, and an input / output interface 440. In some embodiments, the control system 161 includes more than one processor 410, memory 420, storage device 430, and / or input / output interface 440. Each of the components 410, 420, 430, and 440 can be interconnected, for example, using a system bus 450. The processor 410 is capable of processing instructions for execution within the control system 161. The processor 410 can be a single-threaded processor, a multi-threaded processor, or a quantum computer. The processor 410 is capable of processing instructions stored in the memory 420 or the storage device 430.

[0134] The memory 420 stores information within the control system 161. In some embodiments, the memory 420 is a computer-readable medium. The memory 420 may be, for example, a volatile memory unit or a non-volatile memory unit. The storage device 430 is capable of providing mass storage for the control system 139. In some embodiments, the storage device 430 is a non-transitory computer-readable medium. The storage device 430 may include, for example, a hard disk device, an optical disk device, a solid-state drive, a flash drive, a magnetic tape, or some other mass storage device. Alternatively, the storage device 430 may be a cloud storage device, for example, a logical storage device including multiple physical storage devices distributed on a network and accessed using the network.

[0135] The input / output interface 440 provides input / output operations for the control system 161. In some embodiments, the input / output interface 440 includes one or more of a network interface device (e.g., an Ethernet card), a serial communication device (e.g., an RS-232 10 port), and / or a wireless interface device (e.g., an 802.11 card, a 3G wireless modem, or a 4G wireless modem). In some embodiments, the input / output device includes a driver device that is configured to receive input data and send output data to other input / output devices, such as a keyboard, a printer, and a display device (e.g., a display screen 148). In some embodiments, mobile computing devices, mobile communication devices, and other devices are used.

[0136] In some embodiments, the input / output interface 440 includes at least one analog-to-digital converter 441. The analog-to-digital converter converts analog signals into digital signals, e.g., digital signals suitable for processing by the processor 410. One or more sensing elements communicate with the analog-to-digital converter 441, as will be discussed in more detail below.

[0137] In some embodiments, control system 161 is a microcontroller. A microcontroller is a device that contains multiple components of a computer system in a single electronic package. For example, a single electronic package may contain processor 410, memory 420, storage device 430, and input / output interface 440.

[0138] Fig.24 and 25 A block diagram of the hardware system 500 and software system 600 of the fluid conditioning system 100 provided by the control system 161 is provided. Fig.24 As shown, the hardware system 500 is provided by a circuit board for generating a GUI for display on a display screen 148 and one or more circuit boards 135 for controlling electromechanical peripheral components of the fluid conditioning system 100. The software system 600 can be decomposed into an external view 610, an application layer 620, and a driver layer 630. The external view 610 includes a user interface, lights, sounds, and a debug port provided by the GUI. The application layer 620 includes business logic, and the driver layer 630 is configured to enable implementation of peripheral device-specific code (e.g., communication protocols and stepper motor drivers).

[0139] Other embodiments are also possible. For example, Figure 26-30Various configurations of an actuation system 1100 are shown that is designed to control a plurality of valves 1102 (e.g., valves 1102a, 1102b) of a cassette 1104 (e.g., a fluid cassette) within a dialysis system to perform a dialysis treatment. In the example actuation system 1100, the valve 1102 may be an embodiment of a valve 200 of a fluid conditioning system 100, and the cassette 1104 may be an embodiment of a fluid cassette 102 of the fluid conditioning system 100, which may be implemented as a fluid conditioning system 100. The actuation system 1100 includes a drive unit 1106 and a positioning frame 1108, along which the drive unit 1106 may be moved to engage a selected valve 1102. The drive unit 1106 and the positioning frame 1108 may be controlled by a control unit (e.g., in Fig.26 In some embodiments, the control unit 1170 may be implemented as part of the control system 161 of the fluid conditioning system 100. In some embodiments, the drive unit 1106 may provide an embodiment of one or more of the drive unit 130, the motor 129, and the actuator 125 of the fluid conditioning system 100, or may be included in the fluid conditioning system instead of one or more of the drive unit 130, the motor 129, and the actuator 125.

[0140] The positioning frame 1108 of the actuation system 1100 is an xyz table that provides three degrees of freedom for the drive unit 1106 along the box 1104. For example, the positioning frame 1108 includes a first rail 1110 that allows the drive unit 106 to move along the x-axis, a second rail 1112 that allows the drive unit 1106 to move along the y-axis, and a third rail 1114 that allows the drive unit 1106 to move along the z-axis. The first rail 1110 includes two shafts 1116 extending along opposite sides of the box 1104, and the second rail 1112 can slide horizontally along the two shafts 1116 for moving the drive unit 1106 along the x-axis direction. For example, Figure 27-29 The second rail 1112 is shown at three different positions along the x-axis. The second rail 1112 includes an axis 1118 that spans across the box 1104, and the third rail 1114 can slide horizontally along the axis 1118 for moving the drive unit 1106 along the y-axis direction. The third rail 1114 includes an axis 1120 that extends vertically above the box 1104, and the drive unit 1106 can slide vertically along the axis 1120 for moving the drive unit 1106 along the z-axis direction.

[0141] In some embodiments, the first guide rail 1110 can be completely moved across by the second guide rail 1112 in about 0.5 seconds to about 1.0 seconds. In some embodiments, the second guide rail 1112 can be completely moved across by the third guide rail 1114 in about 0.5 seconds to about 1.0 seconds. In some embodiments, the third guide rail 1114 can be completely moved across by the drive unit 1106 in about 0.5 seconds to about 1.0 seconds. Therefore, the positioning frame 1108 and the drive unit 1106 can be controlled so that the drive unit 1106 can be completely moved across the linear first, second and third guide rails 1110, 1112, 1114 in a total time of up to about 0.5 seconds to about 1.0 seconds.

[0142] The drive unit 1106 includes a support base 1122 and an actuator 1124 extending from the support base 1122. The actuator 1124 is formed to engage a mating portion of a valve 1102 such that movement of the actuator 1124 causes movement of the corresponding valve 1102. Once the xy position of the drive unit 1106 has been aligned (e.g., centered) with a selected valve 1102 (e.g., as controlled by a control unit of the dialysis system), the drive unit 1106 can be lowered to engage the valve 1102 and then rotated to actuate (e.g., open or close) the valve 1102.

[0143] For example, when engaged with valve 1102, actuator 1124 can rotate such that actuator 1124 applies a force to valve 1102 to rotate valve 1102 to a selected orientation that connects the internal passage of valve 1102 to an adjacent fluid path to open valve 1102 (e.g., thereby allowing fluid to pass through) or closes the adjacent fluid path to close valve 1102 (e.g., thereby preventing fluid from passing through). In addition, the control unit 1170 of the dialysis system can include an encoder that monitors the rotational position of actuator 1124.

[0144] refer to Fig.31 , the example cartridge 1104 includes six valves 1102 positioned along various fluid paths defined by the cartridge 1104. Four valves 1102a are two-way valves as indicated by key 1126, and two valves 1102b are three-way valves as indicated by key 1128. Fig.32 and 33 Each valve 1102 includes a valve body 1130 defining an internal passage 1154 through which fluid may flow and a valve stem 1132 defining a key 1126 or a key 1128 with which an actuator 1124 may engage to move the valve 1102. Fig.33As shown, the valve body 1130 defines a plurality of recesses 1134, and the valve stem 1132 defines a plurality of protrusions 1136 extending in the recesses 1134, respectively, to couple the valve stem 1132 to the valve body 1130. The valve body 1130 is disposed within the boundaries of the box 1104, and the valve stem 1132 extends away from the box 1104 to be exposed to the actuator 1124.

[0145] Special References Fig.30 , the box 1104 includes two fluid manifolds 1138 to which tubes 1160, 1162 may be attached and lead to respective pumps of the dialysis system (eg, Fig.42 1144, 1146, 1148 where various components of the dialysis system (e.g., pressure transducers, optical sensors, and temperature sensors, etc.) can interface with the cassette 1104.

[0146] Fig.34 and 35 An alternative embodiment of a cassette 1204 is shown that may be acted upon by the actuation system 1100. The cassette 1204 is similar in structure and function to the cassette 1104, but the cassette 1204 includes a different number and arrangement of valves 1102 (e.g., seven valves 1102b), corresponding fluid paths 1250, 1252 along which the valves 1102b are positioned, and corresponding peripheral fluid path openings 1240.

[0147] In some embodiments, results that can be achieved by actuating valve 1102 of box 1104, 1204 include providing water to a dry chemical bag (e.g., bags 306, 307, 309 of fluid conditioning system 100) for mixing, providing dialysate flow to a patient, opening a flow path to a sorbent box (e.g., sorbent box 303 of fluid conditioning system 100), or closing a flow path for heating.

[0148] Due to the ability of the actuation system 100 to control multiple (e.g., all) valves 1102 of the box, the design of the dialysis system including the actuation system 1100 can be simplified (e.g., including fewer components and requiring fewer control algorithms) compared to conventional dialysis systems that require a dedicated mechanism for actuating each valve of the box.

[0149] In some embodiments, the actuator can be matched to the valve based on the operation of the encoder or absolute encoder and matched to the position stored in the memory. Figure 36-41 , upon initialization of the dialysis system, assuming that the interface of the valves 1320 is known, the actuator 1324 of the valve drive assembly 1300 will move to each valve 1320 and adjust the valve position to a known "initialized" state. The connector interface 1302 utilizes a keyed contact structure that includes a spring-loaded axial shaft 1304 (spring-loaded in the z-direction by a spring 1316) that can position a unique interface connection, such as a key 1128.

[0150] The actuator 1324 is rotatable and includes an outer sleeve 1312 surrounding the x-floating valve seat 1306 and the y-floating valve seat 1308. The seal 1310 of the actuator 1324 seals against the top cover of the box. The actuator 1324 also includes a motor attachment 1314. The lead-in profile of the actuator 1324 can move the seats into alignment, allowing the motor to operate like clockwork to rotate the ribs until the seats are ejected upward into the valve 1320. The shaft 1304 can accommodate x / y changes via a unique coupling (e.g., an Oldham coupling) that can offset eccentric loads that may cause downward load constraints so that the shaft 1304 can stabilize the valve seats.

[0151] A number of embodiments have been described in detail above. However, various modifications may be made to these embodiments without departing from the spirit and scope of the above disclosure.

[0152] For example, although the actuation system 1100 and cartridges 1104, 1204 (e.g., including valve 1102) have been described and illustrated as including certain arrangements and configurations, in some embodiments, actuation systems and cartridges that are otherwise structurally and functionally similar to the actuation system 1100 or cartridges 1104, 1204 may include different arrangements or configurations.

[0153] For example, although the boxes 1104, 1204 and actuation system 1100 have been described and illustrated in conjunction with rotary valves, in some embodiments, an actuation system that is otherwise functionally similar to actuation system 1100 may be designed to operate on other types of valves within the dialysate box, such as push-pull valves, pinch valves, or sliding valves, etc.

[0154] Although the actuation system 1100 has been described and shown as being disposed above the cartridges 1104, 1204, in some embodiments, an actuation system that is otherwise structurally and functionally similar to the actuation system 1100 can be disposed below the cartridge to selectively actuate a valve of the cartridge. For example, in some embodiments, such an actuation system can be assembled with the fluid conditioning system 100 at a location below the fluid cartridge such that the orientation of the actuation system is upside down relative to the orientation of the actuation system 1100 as shown. In such embodiments, the actuator of the actuation system can be lifted to engage the valve of the cartridge.

[0155] Although the boxes 1104, 1204 have been described and shown as including a certain number of two-way valves 1102a and three-way valves 1102b, in some embodiments, a box that is otherwise structurally and functionally similar to either of the boxes 1104, 1204 may include a different total number of valves 1102 or a different combination of multiple two-way valves 1102a and multiple three-way valves 1102b, including a group of all two-way valves 1102a and a group of all three-way valves 1102b.

[0156] Although the actuation system 1100 has been described as being used with the fluid conditioning system 100 as part of a larger hemodialysis system, in some embodiments, the actuation system 1100 can be implemented with other types of medical systems, including PD systems, hemofiltration systems, hemodiafiltration systems, plasma separation systems, dialysate generation systems, and water purification systems. For example, the actuation system 1100 can be implemented with a PD system to perform PD treatment. Such a PD system can be operated so that certain valves 1102 are opened and closed to allow the dialysate to be pumped from the dialysate supply bag to the heater bag. After the dialysate in the heater bag is warmed, certain valves 1102 can be opened and closed to pump the warm dialysate to the patient. Then the valve 1102 can be opened and closed to allow the dialysate to be pumped to the heater bag of the warm dialysate again. After the dialysate stays in the patient's peritoneal cavity for a desired period of time, the valve 1102 can be opened and closed to pump the used dialysate from the patient's peritoneal cavity to the drainage system. This process can be repeated multiple times during treatment.

[0157] Furthermore, while the fluid conditioning system 100 has been described and illustrated as including a pressure transducer 119 (PT1, PT2, PT3, PT4) for regulating pump flow rate, in some embodiments, a fluid conditioning system that is otherwise similar in construction and function to the fluid conditioning system 100 may alternatively include a flow meter for regulating pump flow rate in place of a pressure transducer. In some embodiments, a fluid conditioning system that is otherwise similar in construction and function to the fluid conditioning system 100 may not include a pressure transducer or flow meter, but may instead perform RPM control based on detailed knowledge of the system operation to regulate pump flow rate.

[0158] Although the fluid conditioning system 100 has been described and illustrated as including peristaltic pumps 103, 104 (P1, P2, P3, P4), in some embodiments, a fluid conditioning system similar in construction and function to the fluid conditioning system 100 may alternatively include different types of pumps, such as an impeller pump, a linear displacement pump, a positive displacement pump, or a centrifugal pump.

[0159] Although fluid conditioning system 100 has been described and illustrated as including one overflow reservoir (e.g., from reservoir 305), in some embodiments, a fluid conditioning system that is otherwise similar in construction and function to fluid conditioning system 100 may include one or more additional overflow reservoirs. For example, in some embodiments, an additional reservoir may be connected to fluid circuit 350 upstream of pump P1 or downstream of pump P2. In some embodiments, the additional reservoir may have a different capacity than either reservoir 304 or reservoir 305, or may have a zero volume capacity. In some embodiments, the reservoir may be permanently connected to the drain system.

[0160] Although the heater bag 153 has been described and shown as being disposed downstream of the pump P2 of the fluid conditioning system 100, in some embodiments, a fluid conditioning system that is otherwise similar in construction and function to the fluid conditioning system 100 may include heater bags or other heating elements disposed at various locations along the fluid circuit 350 in order to achieve optimal temperature control of the fluid flowing through the fluid circuit 350. For example, in some embodiments, the heater bag may be located immediately downstream of the sorbent cartridge 303 and may be powered based on a signal from the temperature sensor T1 to ensure that the temperature of the dialysis fluid is not high enough to damage the internal components of the sorbent cartridge 303. In some embodiments, the heater bag may be located anywhere along the fluid circuit 350 between valves V1 and V2 as may be advantageous (e.g., to facilitate dissolution of dry chemicals in the supply bags 306, 307, 309).

[0161] Although fluid conditioning system 100 has been described as including three-way valves V1-V7, in some embodiments, a fluid conditioning system that is otherwise similar in construction and function to fluid conditioning system 100 may alternatively include one or more two-way valves to implement the fluid flow path scenarios discussed above.

[0162] Although the operation of the fluid conditioning system 100 has been described and illustrated in conjunction with certain flow rates, fluid volumes, temperatures, pressures, and time periods, in some embodiments, the fluid conditioning system 100 may also be operated to perform fluid conditioning cycles having one or more different flow rates, fluid volumes, temperatures, pressures, and time periods while still functioning as a dialysis system capable of adequately conditioning the dialysate for use in a coordinated manner.

[0163] Although already Figure 23-25 An example control system 161, an example hardware system 500, and an example software system 600 are described respectively, but the implementation of the above-mentioned subject matter and functional operations can also be implemented in other types of digital electronic circuits, or computer software, firmware or hardware including the structures disclosed in this specification and their structural equivalents, or in a combination of one or more of them.

[0164] Implementations of the subject matter described in this specification may be implemented as one or more computer program products, i.e., one or more modules of computer program instructions encoded on a tangible program carrier, such as a computer-readable medium, for execution by a processing system or to control the operation of a processing system. The computer-readable medium may be a machine-readable storage device, a machine-readable storage substrate, a memory device, a composition of matter that effects a machine-readable propagated signal, or a combination of one or more of them.

[0165] The term "computer system" may encompass all devices, apparatuses, and machines for processing data, including, for example, a programmable processor, a computer, or multiple processors or computers. In addition to hardware, a processing system may also include code that creates an execution environment for the computer program in question, for example, code constituting processor firmware, a protocol stack, a database management system, an operating system, or a combination of one or more of them.

[0166] A computer program (also referred to as a program, software, software application, script, executable logic, or code) may be written in any form of programming language, including compiled or interpreted languages, declarative or procedural languages, and may be deployed in any form, including as a stand-alone program or as a module, unit, subroutine, or other unit suitable for use in a computing environment. A computer program does not necessarily correspond to a file in a file system. A program may be stored in a portion of a file that holds other programs or data (e.g., one or more scripts stored in a markup language document), in a single file dedicated to the program in question, or in multiple coordinated files (e.g., files storing one or more modules, subroutines, or portions of code). A computer program may be deployed to execute on one computer, or on multiple computers located at one site or distributed across multiple sites and interconnected by a communications network.

[0167] Computer-readable media suitable for storing computer program instructions and data include all forms of nonvolatile or volatile memory, media, and storage devices, including, for example, semiconductor memory devices, such as EPROM, EEPROM, and flash memory devices; magnetic disks, such as internal hard disks or removable disks or tapes; magneto-optical disks; and CD-ROM and DVD-ROM disks. The processor and memory may be supplemented by, or incorporated in, special purpose logic circuitry. The components of the system may be interconnected by any form or medium of digital data communication, such as a communication network. Examples of communication networks include local area networks ("LANs") and wide area networks ("WANs"), such as the Internet.

[0168] Other embodiments are within the scope of the following claims.

Claims

1. A dialysis machine, comprising: case; a drive unit at least partially located within the housing and comprising an actuator configured to engage and move a plurality of valves disposed within the fluid cartridge to selectively open and close each of the plurality of valves; as well as A positioning frame is positioned within the housing and disposed adjacent the fluid cartridge, the drive unit being movable in three dimensions along the positioning frame to align the actuator with a selected valve of the plurality of valves.

2. The dialysis machine according to claim 1, wherein: The driving unit is carried by the positioning frame.

3. The dialysis machine according to claim 1, wherein: The actuator is formed to mate with a matching feature of each valve of the plurality of valves.

4. The dialysis machine according to claim 1, wherein: The actuator is configured to be controllable to apply a force to each valve of the plurality of valves to rotate each valve of the plurality of valves.

5. The dialysis machine according to claim 4, wherein: The actuator is configured to open and close each valve of the plurality of valves.

6. The dialysis machine of claim 4, wherein: The force is a rotational force.

7. The dialysis machine of claim 1, wherein: The positioning frame further includes first, second and third linear guides, along which the drive unit is linearly movable to align the actuator with the selected valve.

8. The dialysis machine according to claim 7, wherein: The drive unit is configured to be movable across the first, second and third linear guides within a total time of up to about 0.5 seconds to about 2.0 seconds.

9. The dialysis machine of claim 1, wherein: The actuator is configured to open the selected valve to allow fluid to pass through the selected valve.

10. The dialysis machine of claim 1, wherein: The actuator is configured to close the selected valve to prevent fluid from passing through the selected valve.

11. The dialysis machine of claim 1, wherein: The actuator is configured to be controllable to apply a force to each valve of the plurality of valves to move each valve of the plurality of valves in a vertical direction.

12. The dialysis machine of claim 1, wherein: The actuator is configured to be controllable to push, pull or slide each valve of the plurality of valves.

13. A dialysis system comprising: a fluid cartridge carrying a plurality of valves; as well as Dialysis machines, including: case; a valve actuation system located at least partially within the housing and comprising: a drive unit including an actuator configured to engage and move a plurality of valves disposed within the fluid cartridge to selectively open and close each of the plurality of valves; and a positioning frame disposed adjacent the fluid cartridge, the drive unit being movable in three dimensions along the positioning frame to align the actuator with a selected valve of the plurality of valves; and A control unit is configured to control the movement of the valve actuation system.

14. The dialysis system of claim 13, wherein: The driving unit is carried by the positioning frame.

15. The dialysis system of claim 13, wherein: The actuator is formed to mate with a matching feature of each valve of the plurality of valves.

16. The dialysis system of claim 13, wherein: The actuator is configured to be controllable to apply a force to each valve of the plurality of valves to rotate each valve of the plurality of valves.

17. The dialysis system of claim 16, wherein: The actuator is configured to open and close each valve of the plurality of valves.

18. The dialysis system of claim 16, wherein: The force is a rotational force.

19. The dialysis system of claim 13, wherein: The positioning frame includes a first linear guide, a second linear guide, and a third linear guide, and the drive unit is linearly movable along the first linear guide, the second linear guide, and the third linear guide to align the actuator with the selected valve.

20. The dialysis system of claim 19, wherein: The drive unit is configured to be movable across the first, second and third linear guides within a total time of up to about 0.5 seconds to about 2.0 seconds.

21. The dialysis system of claim 13, wherein: The actuator is configured to open the selected valve to allow fluid to pass through the selected valve.

22. The dialysis system of claim 13, wherein: The actuator is configured to close the selected valve to prevent fluid from passing through the selected valve.

23. The dialysis system of claim 13, wherein: The actuator is configured to be controllable to apply a force to each valve of the plurality of valves to move each valve of the plurality of valves in a vertical direction.

24. The dialysis system of claim 23, wherein: The actuator is configured to be controllable to push, pull or slide each valve of the plurality of valves.

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