Systems and methods to prepare dialysis fluid for dialysis
The disposable kit for dialysis systems addresses fluid preparation challenges by incorporating a controller for efficient fluid management and endotoxin removal, enabling high-quality dialysis fluid preparation and delivery, thus improving patient comfort and therapy efficiency.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- MOZARC MEDICAL US LLC
- Filing Date
- 2026-01-14
- Publication Date
- 2026-07-23
AI Technical Summary
Existing dialysis systems face challenges in efficiently preparing dialysis fluid at the point of care, particularly in ensuring the quality and availability of dialysis fluid for peritoneal dialysis, with issues related to endotoxin and bacteria removal, and the need for improved fluid management and control.
A disposable kit for dialysis systems that includes an inlet, outlet, valves, filters, and containers, with a controller to manage fluid flow and quality, ensuring endotoxin and bacteria removal, and a preparator to create dialysis fluid using purified water and concentrates, allowing for separate preparation and administration locations.
Enables efficient, high-quality dialysis fluid preparation at the point of care, reducing preparation time and improving patient comfort by separating noisy preparation from administration, and ensuring consistent fluid delivery for dialysis therapy.
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Abstract
Description
Attorney Docket No. 218079-023301 / PCT Mozarc Ref. No. IDF00016 PCTSYSTEMS AND METHODS TO PREPARE DIALYSIS FLUID FOR DIALYSISCROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U. S. Provisional Patent Application No.63 / 745,514, filed January 15, 2025, and titled “SYSTEMS AND METHODS TO PREPARE DIALYSIS FLUID FOR DIALYSIS”, which is herein incorporated by reference in its entirety.FIELD
[0002] This disclosure relates generally to systems and methods to control dialysis systems.BACKGROUND
[0003] Dialysis systems can be used to treat patients with kidney disorders. Dialysis fluids are used in dialysis therapies for treating patients with these disorders.SUMMARY
[0004] In some embodiments, a disposable kit configured for use in a dialysis system includes an inlet configured to receive a dialysis fluid from a preparator of the dialysis system and an outlet configured to be connected to a cycler of the dialysis system. In some embodiments, the disposable kit configured for use m the dialysis system includes a plurality’ of containers, wherein the plurality of containers are configured to be fluidly connected to the inlet. In some embodiments, the plurality of containers are configured to be fluidly connected to the outlet. In some embodiments, the disposable kit configured for use in the dialysis system includes a plurality of valves fluidly disposed between the inlet and the outlet. In some embodiments, the plurality' of valves are configured to selectively control fluid flow to the plurality of containers. In some embodiments, the disposable kit configured for use in the dialysis system includes a filter fluidly disposed between the plurality' of valves and the inlet. In some embodiments, the filter is configured to remove endotoxin and bacteria.
[0005] In some embodiments, the disposable kit includes a pump configured to control a flowrate of the dialysis fluid from the inlet.I ACTIVE 717526587v2Attorney Docket No. 218079-023301 / PCT MozarcRef. No. IDF00016 PCT
[0006] In some embodiments, the disposable kit includes a second disposable kit fluidly connected to the outlet to receive the dialysis fluid; wherein the second disposable kit is configured to be connected to the cycler.
[0007] In some embodiments, the dialysis fluid includes a mixture including purified water and one or more dialysis concentrates.
[0008] In some embodiments, the disposable kit includes a second filter fluidly disposed between the filter and the plurality of containers.
[0009] In some embodiments, the first of the plurality' of containers is configured to be filled. In some embodiments, a second of the plurality of containers is configured to be filled in response to completion of the first of the plurality of containers being filled.
[0010] In some embodiments, the first of the plurality of containers and a second of the plurality’ of containers is configured to be filled concurrently.
[0011] In some embodiments, a dialysis system includes a water treatment system configured to purify a source water. In some embodiments, a dialysis system includes a preparator configured to provide a dialysis fluid. In some embodiments, a dialysis system includes a cycler configured to control a dialysis therapy. In some embodiments, a dialysis system includes a disposable kit including an inlet configured to be fluidly connected to the preparator. In some embodiments, the inlet is configured to receive the dialysis fluid, components of the dialysis fluid, water, or any combination thereof from the preparator. In some embodiments, the disposable kit includes an outlet configured to be connected to the cycler. In some embodiments, the disposable kit includes a plurality of containers. In some embodiments, the plurality of containers are configured to be fluidly connected to the inlet. In some embodiments, the plurality of containers are configured to be fluidly connected to the outlet. In some embodiments, the disposable kit includes a plurality of valves fluidly disposed between the inlet and the outlet. In some embodiments, the plurality of valves are configured to selectively control fluid flow to the plurality of containers. In some embodiments, the disposable kit includes a ultrafilter fluidly disposed between the plurality of valves and the inlet. In some embodiments, the dialysis system includes a sensor configured to determine a first amount of the dialysis fluid in a first of the plurality of containers. In some embodiments, the dialysis system includes a controllerACTIVE 717526587v2Attorney Docket No. 218079-023301 / PCT MozarcRef. No. IDF00016 PCT configured to control the water treatment system, the preparator, and the plurality of valves in the disposable kit. In some embodiments, the controller is configured to control the plurality of valves using the first amount of the dialysis fluid in the first of the plurality of containers as sensed.
[0012] In some embodiments, the controller is configured to control the plurality of valves to fill the first of the plurality of containers and in response to completing filling of the first of the plurality of containers. In some embodiments, the controller is configured to control the plurality of valves to fill a second of the plurality of containers.
[0013] In some embodiments, the controller is configured to control the plurality of valves to fill the plurality of containers concurrently.
[0014] In some embodiments, the controller is configured to control the preparator to fill the plurality of containers and in response to the plurality of containers being filled, the controller is configured to enable the cycler to perform the dialysis therapy.
[0015] In some embodiments, the controller is configured to control the preparator to fill the first of the plurality of containers and in response to the first of the plurality of containers being filled, the controller is configured to enable the cycler to perform the dialysis therapy,
[0016] In some embodiments, the controller is configured to control the preparator to fill the first of the plurality of containers and the controller is configured to concurrently enable the cycler to perform the dialysi therapy,
[0017] In some embodiments, the dialysis system includes a drain fluidly connected to the disposable kit. In some embodiments, in response to determining a composition of the dialysis fluid does not meet a defined composition, the controller is configured to direct the dialysis fluid to the drain.
[0018] In some embodiments, the dialysis system includes a second filter fluidly disposed between the filter and the plurality of containers.
[0019] In some embodiments, the dialysis system includes a heater configured to heat the dialysis fluid, water, components of the dialysis fluid, or any combination thereof.3ACTIVE 717526587v2Attorney Docket No. 218079-023301 / PCT MozarcRef. No. IDF00016 PCT
[0020] In some embodiments, the sensor includes a plurality of sensors. In some embodiments, each of the plurality of sensors is configured to determine a respective amount of the dialysis fluid in each of the plurality of containers.
[0021] In some embodiments, a disposable kit configured for use in a dialysis system includes an inlet configured to receive a dialysis fluid from a preparator of the dialysis system. In some embodiments, the disposable kit configured for use m the dialysis system includes a plurality of containers. In some embodiments, the plurality of containers are configured to be fluidly connected to the inlet. In some embodiments, the disposable kit configured for use in the dialysis system includes a plurality of valves fluidly disposed between the inlet and the plurality of containers. In some embodiments, the plurality of valves are configured to selectively control fluid flow to the plurality of containers. In some embodiments, the disposable kit configured for use in the dialysis system includes a filter fluidly disposed between the plurality of valves and the inlet. In some embodiments, the disposable kit configured for use in the dialysis system includes a sensor configured to determine a concentration of components within the dialysis fluid in a first of the plural ity of containers,
[0022] In some embodiments, the disposable kit configured for use in the dialysis system includes including a pump configured to control a flowrate of the dialysis fluid from the inlet.
[0023] In some embodiments, the disposable kit is configured to be fluidly isolated from a cycler of the dialysis system.
[0024] In some embodiments, the sensor is a load cell sensor.
[0025] In some embodiments, the load cell sensor is configured to determine a weight of the first of the plurality of containers.
[0026] In some embodiments, the sensor is configured to determine an amount of the dialysis fluid in the plurality of containers.
[0027] In some embodiments, the dialysis fluid includes a mixture including purified water and one or more dialysis concentrates.4ACTIVE 717526587v2Attorney Docket No. 218079-023301 / PCT MozarcRef. No. IDF00016 PCT
[0028] In some embodiments, the disposable kit configured for use in the dialysis system includes a second filter fluidly disposed between the filter and the plurality of containers.
[0029] In some embodiments, the first of the plurality of containers is configured to be filled and a second of the plurality of containers is configured to be filled in response to completion of the first of the plurality of containers being filled.
[0030] In some embodiments, the first of the plurality of containers and a second of the plurality of containers is configured to be filled concurrently.
[0031] In some embodiments, a dialysis system includes a water treatment system configured to purify a source water. In some embodiments, a dialysis system includes a preparator configured to provide a dialysis fluid. In some embodiments, a dialysis system includes a disposable kit including an inlet configured to be fluidly connected to the preparator. In some embodiments, the inlet is configured to receive the dialysis fluid from the preparator, constituents of the dialysis fluid, or some combination thereof. In some embodiments, the disposable kit includes a plurality of containers. In some embodiments the plurality of containers are configured to be fluidly connected to the inlet. In some embodiments, the disposable kit includes a plurality of valves fluidly disposed between the inlet and the plurality of containers. In some embodiments, the plurality of valves are configured to selectively control fluid flow to the plurality of containers. In some embodiments the disposable set includes a filter fluidly disposed between the plurality of valves and the inlet. In some embodiments, the dialysis system includes a sensor configured to determine a first amount of the dialysis fluid in a first of the plurality of containers. In some embodiments, the dialysis system includes a controller configured to control the water treatment system, the preparator, and the plurality of valves in the disposable kit. In some embodiments, the controller is configured to control the plurality of valves using the first amount of the dialysis fluid in the first of the plurality of containers as sensed.
[0032] In some embodiments the controller is configured to control the plurality of valves to fill the first of the plurality of containers and in response to completing filling of the first of the plurality of containers, the controller is configured to control the plurality of valves to fill a second of the plurality of containers.5ACTIVE 717526587v2Attorney Docket No. 218079-023301 / PCT MozarcRef. No. IDF00016 PCT
[0033] In some embodiments, the controller is configured to control the plurality of valves to fill the plurality of containers concurrently.
[0034] In some embodiments, the controller is configured to control the cycler to perform the dialysis therapy.
[0035] In some embodiments, the dialysis system includes a second disposable kit;wherein the second disposable kit is configured to be fluidly connected to a cycler.
[0036] In some embodiments, the second disposable kit is configured to be fluidly connected to the plurality of containers in response to the plurality of containers being fluidly disconnected from the disposable kit.
[0037] In some embodiments, a dialysis system includes a drain fluidly connected to the disposable kit. In some embodiments, in response to determining a composition of the dialysis fluid does not meet a defined composition, the controller is configured to direct the dialysis fluid to the drain.
[0038] In some embodiments, a dialysis system includes a second sterilizing ultrafilter fluidly disposed between the sterilizing ultrafilter and the plurality of containers.
[0039] In some embodiments, the cycler includes a heater configured to heat the dialysis fluid.
[0040] In some embodiments, the sensor includes a plurality of sensors. In some embodiments, each of the plurality of sensors is configured to determine a respective amount of the dialysis fluid in each of the plurality' of containers.BRIEF DESCRIPTION OF THE DRAWINGS
[0041] References are made to the accompanying drawings that form a part of this disclosure and that illustrate embodiments in which the systems and methods described in this Specification can be practiced.
[0042] FIG. 1 is a schematic diagram of a dialysis system, according to some embodiments.
[0043] FIG. 2 shows a schematic diagram of the cycler of FIG. 1, according to some embodiments.6ACTIVE 717526587v2Attorney Docket No. 218079-023301 / PCT MozarcRef. No. IDF00016 PCT
[0044] FIG. 3 shows a schematic diagram of the preparator of FIG. 1, according to some embodiments.
[0045] FIG. 4 shows a schematic diagram of the preparator disposable kit, according to some embodiments.
[0046] FIG. 5 shows a schematic diagram of the preparator disposable kit, according to some embodiments.
[0047] Like reference numbers represent the same or similar parts throughout.DETAILED DESCRIPTION
[0048] This disclosure relates to dialysis systems including a preparator to create dialysis fluid for peritoneal dialysis. Automated peritoneal dialysis can rely upon a cycler to perform a sequential exchange of dialysis fluid for a patient. The cycler can control a fill phase (dialysis fluid filled into a patient’s peritoneal cavity), a dwell phase (period during which the dialysis fluid is left in the patient’s peritoneal cavity), and a drain phase (period during which the dialysis fluid is removed from the patient’s peritoneal cavity). During the phases of exchange of dialysis fluid with a patient, the cycler can actuate a membrane covered cassette to cause the fluid to fill or drain from the patient’s peritoneal cavity.
[0049] Embodiments of this disclosure are directed to systems and methods for creating dialysis fluid for a dialysis therapy at the point of care.
[0050] As used herein, a “cycle” can include at least one of a fill phase (e.g., an injection phase), a dwell phase, and a drain phase, or any combination thereof.
[0051] FIG. 1 is a schematic diagram of a dialysis system 100, according to some embodiments. In some embodiments, the dialysis system 100 can be representative of a peritoneal dialysis system including point of use dialysis fluid production. Peritoneal dialysis systems are one example of a dialysis system. It is to be appreciated that the systems and methods described in this disclosure can be applied to other dialysis systems such as, but not limited to, hemodialysis, hemofiltration, hemodiafiltration, or the like.
[0052] The illustrated embodiment includes a dialysis fluid preparation system, i.e., a preparator 102. A controller 104 is configured to be in electronic communication with the preparator 102 to send and receive communications relating to sensed parameters, control 7ACTIVE 717526587v2Attorney Docket No. 218079-023301 / PCT MozarcRef. No. IDF00016 PCT of valves, or the like. The preparator 102 can be, in some embodiments, fluidly connected to a cycler 106. The cycler 106 can be fluidly connected with a patient to perform the dialysis treatments.
[0053] In some embodiments, the preparator 102 can be locationally separate from the cycler 106. For example, the preparator 102 can be located in a separate room from the cycler 106 to generate the dialysis fluid. Upon generating the dialysis fluid, the fluid can be taken from the preparator 102 and manually connected to the cycler 106, thereby providing the fluid used by the cycler 106 for the peritoneal dialysis. This can, in some embodiments, permit the patient to keep the preparator 102 in an area separate from where the dialysis therapy is administered. For example, if the preparator 102 is noisy, the patient may want to keep the preparator 102 in a different location such that the noise can be less of a nuisance. Additionally, having the preparator 102 spatially separate from where the patient administers the dialysis therapy can improve organization of the home. For example, logistically, the patient can have the preparator 102 in one location and the remainder of the dialysis system 100 in another. The preparator 102 can be stored in a location in close spatial relation to the mam water supply of the patient’s home,
[0054] The cycler 106 can be configured to inject, or fill, the dialysis fluid into the patient and dram the dialysis fluid during the end of a cycle or when the treatment is complete. The cycler 106 can receive a prepared dialysis fluid from the preparator 102. The cycler 106 can be in electronic communication with the controller 104 to accomplish the necessary treatments for the patient.
[0055] In some embodiments, the preparator 102 can include a water treatment system 112 to treat an inlet water and then prepare fresh dialysis fluid using a proportioning system 114 that receives the purified water output from the preparator 102. For example, the proportioning system 114 can be used to generate the fresh dialysis fluid using purified water received from the water treatment system 112 and combined with one or more dialysate concentrates (e.g., glucose, ion concentrations, bicarbonate, combinations thereof, or the like). The proportioning system 114 can be in electronic communication with the controller 104 and the cycler 106 to accomplish the necessary treatments for the patient. In some embodiments, the preparator 102 can be in electronic communication with8ACTIVE 717526587v2Attorney Docket No. 218079-023301 / PCT MozarcRef. No. IDF00016 PCT the cycler 106 to accomplish the necessary’ treatments for the patient. In some embodiments, the water treatment system 112 can purify tap water to be used in generation of the dialysis fluid. For example, the inlet water can be from the patient’s household residence. In some embodiments, the dialysis fluid comprises a mixture comprising purified water and one or more dialysis concentrates.
[0056] It is to be appreciated that the cycler 106 can include one or more additional features such as, but not limited to, an interface device including user interface configured to receive user inputs, display outputs for the user, or any combination thereof.
[0057] The controller 104 can be in wired or wireless communication with the preparator 102. The controller 104 can include a memory 108 and at least one processor 110. It is to be appreciated that the controller 104 can include one or more additional features such as, but not limited to, a display with a user interface configured to receive user inputs, display outputs for the user, or any combination thereof. In some embodiments, a separate user input can also be included so the user can interact with the dialysis system 100.
[0058] FIG, 2 shows a schematic diagram of the cycler 106 of FIG. 1, according to some embodiments. As discussed above, the cycler 106 is configured to control a dialysis therapy for a patient. Specifically, the cycler 106 is configured to fill or pump the dialysis fluid into the patient’s peritoneal cavity (fill phase), wait a period of time (dwell phase), then drain the dialysis fluid from the patient’s peritoneal cavity (drain phase). The first cycle can, in some embodiments, include an initial drain phase. In some embodiments, the initial drain can occur before the first cycle. In some embodiments, the last cycle can include a final fill phase, which can occur after the last cycle, to bring a volume within the peritoneal cavity up to the initial level less the ultrafiltrate volume collected during the drain. In some embodiments, the final fill phase to bring a volume within the peritoneal cavity up to the initial level can occur after the last cycle. For example, in some embodiments, a cycle can include a single fill phase, a single dwell phase, and a single dram phase.
[0059] The cycler 106 can include at least one processor 150 and a memory 152. The cycler can include a control panel 154. In some embodiments, the control panel 154 can include a display 156 and an input 158. In some embodiments, the display 156 and the9ACTIVE 717526587v2Attorney Docket No. 218079-023301 / PCT MozarcRef. No. IDF00016 PCT input 158 can be combined in a single touchscreen. In some embodiments, the cycler 106 can include a dialysis fluid pump 160. In some embodiments, an outlet 162 from the cycler 106 can be configured to be connected to a conduit that is subsequently connected to a patient to accomplish the dialysis therapy using dialysis fluids as controlled by the cycler 106. For example, in some embodiments, the outlet 162 can be used to transfer dialysis fluid to the patient from the cycler 106. In some embodiments the memory’ 152 can include computer readable instructions that, when executed by the processor 150, causes the at least one processor 150 to perform certain actions, explained in detail below.
[0060] In some embodiments, the cycler 106 can include a heater 166 to heat the dialysis fluid. In some embodiments, the heater 166 can rest atop the cycler 106. The heater 166 can be thermally connected to the cycler 106 and the cassette 164, In some embodiments, a cassette 164 can be fluidly connected to a heating bag that can absorb heat from the heater 166, In some embodiments, the dialysis system 100 can include a heating plate as the heater 166, In some embodiments, the heater 166 of the dialysis system 100 can be spatially separate from the cycler 106, while remaining sufficiently close such that fluid can be transfer adjacent to the heater 166 to heat the dialysis fluid. It can be beneficial to heat the dialysis fluid to a specific temperature before delivering the dialysis fluid to the patient, as a cold dialysis fluid (e.g., a dialysis fluid at a temperature other than a physiological temperature) being introduced to the peritoneal cavity can be uncomfortable for the patient.
[0061] In some embodiments, the at least one processor 150 can alternatively be referred to as a controller. In some embodiments, the at least one processor 150 can be the controller 104. In some embodiments, the at least one processor 150 is configured to modify a peritoneal dialysis therapy of a patient in view of one or more inputs received via the control panel 154. The one or more inputs received via the control panel 154 can include one or more inputs defining a peritoneal dialysis therapy for a patient. For example, in some embodiments the one or more inputs can include one or more of: total therapy time, a total therapy volume, a fill volume, an estimated ultrafiltration (‘UF’ ), a dwell time, and the number of cycles.10ACTIVE 717526587v2Attorney Docket No. 218079-023301 / PCT Mozarc Ref. No. IDF00016 PCT
[0062] In some embodiments, the cycler 106 can act on a cassette 164 in fluid communication with the patient. In some embodiments, the cassette 164 can be a disposable cassette 164 configured to transfer fluid through a plurality of flow paths therein. In some embodiments, a plurality’ of tubes can be connected to the cassette 164 to transfer fluid between a drain, the patient, a dialysate source, a heating element, or some combination thereof. In some embodiments, the cycler 106 can be operably engaged to the cassette 164. By acting on the cassette 164, the cycler 106 can drain fluid from the patient or deliver fluid to the patient. In some embodiments, the cassette 164 can be input into the cycler 106 through a cycler 106 door (not shown.) In some embodiments, the cassette 164 can be disposable and input or removed before or after each dialysis session, respectively, as desired. In some embodiments, the cassette 164 is disposable.
[0063] Turning to FIG, 3, in some embodiments, the dialysis system 100 can include a preparator 102 configured to prepare the dialysis fluid to be delivered by the cycler 106, as described above. The preparator 102 can be designed to purify water and generate fluid for use in peritoneal dialysis. In some embodiments, the preparator 102 can generate the peritoneal dialysis fluid by combining the purified water with dialysate chemical constituents. In some embodiments the dialysate chemical constituents can be in liquid form. In some embodiments the dialysate chemical constituents can be in powder form. In some embodiments, the powder dialysate chemical constituents can include an electrolyte, an osmotic agent, or any combination thereof. In some embodiments, the powder form includes a reconstitution to liquid form before being mixed with the purified water in the preparator 102 to create the peritoneal dialysis fluid. In some embodiments, the reconstitution to liquid form can be done by the preparator 102 in the process of creating the dialysis fluid.
[0064] The dialysis system 100 can, in some embodiments, include a preparator disposable kit 302 hydraulically connected to the preparator 102. The preparator disposable kit 302 can be fluidly connected to, at least, the proportioning system 114 to receive the peritoneal dialysis fluid from the preparator 102, the components to create the dialysis fluid (i.e., liquid concentrate, purified water), or some combination thereof. The preparator disposable kit 302 can be fluidly connected to the cycler 106, the cassette 164, or some11ACTIVE 717526587v2Attorney Docket No. 218079-023301 / PCT Mozarc Ref. No. IDF00016 PCT combination thereof, to deliver the dialysis fluid to the cycler 106, the cassette 164, or some combination thereof.
[0065] In reference to FIG. 4, and FIG. 5 the preparator disposable kit 302, according to some embodiments, can include at least one inlet 402, at least one outlet 404, a plurality of containers 406, and a plurality of valves 410. In some embodiments the preparator disposable kit 302 can include at least one scale 408 to weigh the plurality of containers 406. In some embodiments, the at least one scale 408 can be used to ensure a desired concentration of the components to create the dialysis fluid. In some embodiments, the preparator disposable kit 302 can include at least one drain 412. In some embodiments, the preparator disposable kit 302 does not include at least one scale 408. In some embodiments, the dialysis system 100 includes at least one scale 408,
[0066] In some embodiments, the at least one inlet 402 can be configured to fluidly connect to the preparator 102, The at least one inlet 402 of the preparator disposable kit 302 can, in some embodiments, receive the dialysis fluid from the preparator 102. In some embodiments, the at least one inlet 402 can be a plurality of inlets to receive fluid from the preparator 102. Fluid from the preparator 102 can enter the preparator disposable kit 302 through the at least one inlet 402 and exit the preparator disposable kit 302, to be directed to the cycler 106, through the at least one outlet 404.
[0067] In some embodiments, the outlet 404 can be optional. For example, the fluid for the dialysis fluid can reside in the plurality of containers 406, which are filled by the preparator 102 at a location remote from the cycler 106, and, in some embodiments, the preparator disposable kit 302. When the plurality of containers 406 are filled with dialysis fluid, they can be removed from the preparator 102 and preparator disposable kit 302 and hooked up to the cycler 106 directly. In some embodiments, the preparator disposable kit 302, including the plurality of containers 406, can be disconnected from the preparator 102 after the dialysis fluid has been prepared. The preparator disposable kit 302 can be, in some embodiments, connected to the cycler 106 directly without being simultaneously connected to the preparator 102.
[0068] The outlet 404 can, in some embodiments, be configured to be connected to the cycler 106. While passing through the preparator disposable kit 302, the controller 10412ACTIVE 717526587v2Attorney Docket No. 218079-023301 / PCT Mozarc Ref. No. IDF00016 PCT can direct fluid through the preparator disposable kit 302 to exit the outlet 404 towards the cycler 106, the cassette 164, or some combination thereof. As such, the outlet 404 can be fluidly connected to the cycler 106, the cassette 164, or some combination thereof. The controller 104 can selectively control the plurality of valves 410 to direct fluid from within the preparator disposable kit 302 through the outlet 404. In some embodiments, the controller 104 can control the preparator 102, the plurality of valves 410 in the disposable kit, the cycler 106, or some combination thereof.
[0069] In some embodiments, the plurality of valves 410 can be disposed between the inlet 402 and the outlet 404 of the preparator disposable kit 302. The plurality of valves 410 can be selectively controlled by the controller 104 to direct fluid throughout the preparator disposable kit 302, For example, the plurality of valves 410 can permit fluid to enter the inlet 402 and direct that fluid to the outlet 404, at least one dram port 412, the plurality of containers 406, the outlet 404, or some combination thereof. The controller 104 can actuate the plurality of valves 410 to direct fluid towards the inlet 402, the outlet 404, the plurality of containers 406 and the at least one drain 412 and can actuate the plurality of valves 410 to pull fluid from the inlet 402, the outlet 404, the plurality of containers 406, and the at least one drain 412.
[0070] In some embodiments, the preparator disposable kit 302 can include at least one sensor 414 to determine the amount of fluid in at least one container of the plurality of containers 406. In some embodiments, the dialysis system 100 can include at least one sensor 414 to determine the composition of the fluid in at least one container of the plurality of containers 406. For example, the at least one sensor 414 can, in some embodiments, interface with the preparator disposable kit 302. In some embodiments, the preparator disposable kit 302 can include at least one sensor 414 to determine the composition of the fluid in at least one container of the plurality of containers 406. In some embodiments, the at least one sensor 414 is the at least one scale 408. In some embodiments, the at least one sensor 414 can include a sensor configured to measure the flow rate to determine the volume of fluid within the plurality of containers 406. In some embodiments, the dialysis system 100 includes the at least one sensor 414 and the at least one scale 408. In some embodiments, the dialysis system 100 includes the at least one sensor 414. In some embodiments, the at least one sensor 414 can determine a first amount of the dialysis fluid 13ACTIVE 717526587v2Attorney Docket No. 218079-023301 / PCT Mozarc Ref. No. IDF00016 PCT in a first container of the plurality of containers 406. In some embodiments, the controller 104 can control the plurality of valves 410 using the first amount of the dialysis fluid in the first container of the plurality of containers 406 as sensed by the at least one sensor 414, the at least one scale 408, or some combination thereof. In some embodiments, the at least one sensor 414 can be configured to provide data to the controller 104 to permit the controller 104 to determine a respective amount of dialysis fluid in each of the plurality of containers 406. In some embodiments, the at least one sensor 414 is a plurality of sensors. In some embodiments, the at least one sensor 414 can be a load cell sensor. The load cell sensor can be configured to determine a weight of the plurality of containers 406. In some embodiments, the load cell sensor can be configured to determine a weight of a first container of the plurality of containers 406.
[0071] The preparator disposable kit 302 can, in some embodiments, include the plurality of containers 406 to store the fluid received by the preparator disposable kit 302 through the inlet 402. In some embodiments, the fluid can be prepared by the preparator 102 and transferred to the preparator disposable kit 302 through the inlet 402, The plurality of valves 410 can direct the fluid from the preparator 102 from the inlet 402 to the plurality of containers 406 for storage, mixing, or some combination thereof. For example, in some embodiments, the fluid from the preparator 102 can be a dialysis fluid ready for transfer to the cycler 106 through outlet 404. In some embodiments, the fluid from the preparator 102 can be a fluid that requires additional mixing before being transferred to the cycler 106. To determine if a sufficient amount of fluid has been prepared by the preparator 102, the preparator disposable kit 302 can include the at least one scale 408 configured to weigh at least one of the plurality of containers 406. In some embodiments, the at least one scale 408 is configured to proportion a desired amount of dialysis fluid components.
[0072] The at least one scale 408 can be adjacent to the at least one container to be weighed of the plurality of containers 406. For example, in some embodiments, the plurality of containers 406 can include fluidly separate containers that can each be connected to the plurality of valves 410. The controller 104 can direct fluid from preparator 102 to the container to be weighed by the at least one scale 408. Once the fluid within the container being weighed by the 408 reaches a threshold, the controller 104 can transfer the fluid in the container being weighed to the rest of the plurality of containers 406, the outlet 404,14ACTIVE 717526587v2Attorney Docket No. 218079-023301 / PCT Mozarc Ref. No. IDF00016 PCT the at least one drain 412, or some combination thereof. In some embodiments, the controller 104 can direct fluid into other containers included in the plurality of containers 406 until a target volume has been determined, at least in part, by the at least one scale 408. In some embodiments, the controller 104 can direct fluid into other containers included in the plurality of containers 406 until a target volume has been determined, at least in part, by the at least one sensor 414. The target volume, in some embodiments, can be the volume of dialysis fluid needed for the therapy. In some embodiments, the target volume can be a prescribed volume in addition to priming volume plus buffer volume. In some embodiments, the at least one scale 408 can weigh more than one container of the plurality of containers 406 simultaneously. In some embodiments, the at least one scale 408 can be a plurality of scales each weighing a respective container within the plurality of containers 406. In some embodiments, the at least one scale 408 is the at least one sensor 414.
[0073] In some embodiments, a first container of the plurality of containers 406 can be filled by the fluid from the preparator 102, The controller 104 can determine that the first container of the plurality of containers 406 has reached a filling threshold volume. In some embodiments, the controller 104 can determine the volume of a container of the plurality of containers 406 from the weight of the plurality of containers 406 via the at least one scale 408. The controller 104 can determine that the first container of the plurality of containers 406 has been filled or that the process of filling the first container of the plurality of containers 406 is complete. In some embodiments, the controller 104 can determine the first container of the plurality of containers 406 is filled when it reaches the filling threshold volume. When the controller 104 determines that the first container of the plurality of containers 406 is filled, the controller 104 can control the plurality of valves 410 to fill a second container of the plurality of containers 406. In some embodiments, the controller 104 can fill the plurality of containers 406 in series until the plurality of containers 406 are filled with fluid. In some embodiments the controller 104 can fill the plurality of containers 406 one after another until a desired amount of the plurality of containers 406 are filled with fluid. In some embodiments, the controller 104 can control the plurality of valves 410 to fill the plurality of containers 406 concurrently. For example, the controller 104 can control the plurality of valves 410 to fill more than one containers of the plurality of containers 406, simultaneously with fluid from the preparator 102.15ACTIVE 717526587v2Attorney Docket No. 218079-023301 / PCT Mozarc Ref. No. IDF00016 PCT
[0074] In some embodiments, the controller 104 can enable the cycler to perform the dialysis therapy based on a status of the plurality of containers 406. For example, if the controller 104 determines that the plurality of containers 406 are filled, the controller 104 can be configured to enable the cycler to perform the dialysis therapy.
[0075] In some embodiments, the controller 104 can enable the cycler to perform the dialysis therapy when it determines that the first container of the plurality of containers 406 is filled. This can enable the dialysis system 100 to deliver fluid to the patient with less preparation time. For example, while the preparator 102 is generating the remaining fluid for a remaining number of containers of the plurality of containers 406, the controller 104 can determine that the fluid within the first container of the plurality of containers 406 is ready for patient delivery. The preparator 102 can generate fluid to fill the first container of the plurality of containers 406, which the controller 104 can deliver to the cycler 106 while the preparator 102 can generate the remaining amount of fluid for the therapy. In some embodiments, the controller 104 can calculate the time necessary for the preparator 102 to generate the remaining fluid for the remaining containers of the plurality of containers 406. The controller 104 can use the calculated time to determine a time to enable the cycler 106 to perform the dialysis therapy such that there can be no delay, as a result of waiting for the remaining fluid from the preparator 102 for the therapy.
[0076] In some embodiments, to enable the cycler 106 to perform the dialysis therapy, the controller 104 can control the plurality of valves 410 to direct the dialysis fluid from the first container of the plurality of containers 406, the second container of the plurality of containers 406, more than one of the plurality of containers 406, or some combination thereof, through the outlet 404 to the cycler 106. In some embodiments, the controller 104 can control the plurality of valves 410 to direct fluid through the outlet 404 while simultaneously, or concurrently, filling the plurality of containers 406 with fluid from the inlet 402. For example, in some embodiments, the controller 104 can control the plurality of valves 410 to direct fluid to at least one container of the plurality of containers 406 while controlling the plurality of valves 410 to draw fluid from a separate container of the plurality of containers 406 and direct the fluid from the separate container to the cycler 106, through outlet 404, to enable the cycler 106 to perform the dialysis therapy. The16ACTIVE 717526587v2Attorney Docket No. 218079-023301 / PCT MozarcRef. No. IDF00016 PCT controller 104 can have the capability of controlling fluid in various directions, at the same time, by controlling the plurality of valves 410.
[0077] In some embodiments, the preparator disposable kit 302 can include at least one drain 412 fluidly connected to the plurality’ of valves 410 to permit the controller 104 to send fluid through the drain 412. In some embodiments, the drain 412 directs fluid from the preparator disposable kit 302 to a fluid waste disposal. In some embodiments, the drain 412 directs fluid from the preparator disposable kit 302 to a waste container until it can be disposed of. In some embodiments, the drain 412 directs fluid to an area that is not fluidly connected to the patient. The controller 104 can, in some embodiments, direct fluid that is not to be used in the dialysis therapy through the at least one drain 412 to dispose of the fluid.
[0078] In some embodiments, the controller 104 can determine a composition of the dialysis fluid. In some embodiments, the controller 104 can detect fluid properties of the dialysis fluid via the at least one sensor 414, The at least one sensor 414 can be at least one conductivity sensor, a light refraction sensor, a dextrose sensor, or some combination thereof. In response to determining a composition of the dialysis fluid does not meet a defined composition, the controller 104 can, in some embodiments, be configured to direct the dialysis fluid to the drain.
[0079] Still in reference to FIG. 4, in some embodiments, the preparator disposable kit 302 can include at least one filter 418 configured to remove bacteria and endotoxin. The at least one filter 418 can be a sterilizing filter. The at least one filter 418 can be fluidly disposed between the at least one inlet 402 and the plurality of valves 410. In some embodiments, the at least one filter 418 can be fluidly connected to the at least one dram 412 such that, if the controller 104 determines that the dialysis fluid is not be a desired composition, if the controller 104 determines the dialysis fluid is not safe for patient use, if the controller 104 determines that the dialysis fluid should be flushed from the system, or some combination thereof, the controller 104 can direct the fluid from the at least one filter 418 directly to the at least one dram 412. In some embodiments, the preparator disposable kit 302 can include at least one filter 418 disposed fluidly between the plurality of containers 406 and the plurality of valves 410. In some embodiments, the preparator17ACTIVE 717526587v2Attorney Docket No. 218079-023301 / PCT Mozarc Ref. No. IDF00016 PCT disposable kit 302 can include a first filter of at least one filter 418 fluidly between the inlet 402 and the plurality' of valves 410 and a second filter of at least one filter 418 fluidly between the plurality of containers 406 and the plurality’ of valves 410. In some embodiments the preparator disposable kit 302 can include a second filter fluidly disposed between the first filter of the at least one filter 418 and the plurality of containers 406. In some embodiments, the at least one filter 418 can be a sterilizing filter. In some embodiments, the at least one filter 418 can be at least one ultrafilter. In some embodiments, the at least one filter can be a sterilizing filter. In some embodiments, the at least one filter can be a flat filter. In some embodiments, the at least one filter can be a nano filter.
[0080] In some embodiments the preparator disposable kit 302 can include a pump 420 configured to control a flowrate of the dialysis fluid from the inlet 402, The pump 420 can be used to deliver fluid through the preparator disposable kit 302, for example, to and from the plurality of containers 406, to the at least one drain 412, to the outlet 404, or some combination thereof. The pump 420 can be fluidly connected to the inlet 402, the outlet 404, the plurality of containers 406, the plurality of valves 410, the at least one drain 412, or some combination thereof. In some embodiments, the pump 420 can be controlled by the controller 104. The controller 104 can use the flowrate data from the pump 420 to determine, in some embodiments, the amount of fluid residing in the plurality of containers 406. In some embodiments, the controller 104 can use the delivered volume data from the pump 420 to determine the amount of fluid residing in the plurality of containers 406. In some embodiments, the pump 420 can be a volumetric pump. In some embodiments, the dialysis system 100 can include a flow meter within the preparator 102 to measure the flow of fluid therethrough.
[0081] In some embodiments the preparator disposable kit 302 can include a second preparator disposable kit 302, fluidly connected to receive the dialysis fluid. In some embodiments, the second preparator disposable kit 302 can be configured to be connected to the cycler. The second preparator disposable kit 302 can be used for additional filtering via the at least one filter 418, to process more dialysis fluid from the preparator 102, or some combination thereof. The second preparator disposable kit 302 can be fluidly parallel or in series with one another. For example, the first and second preparator disposable kit 18ACTIVE 717526587v2Attorney Docket No. 218079-023301 / PCT Mozarc Ref. No. IDF00016 PCT 302 can both be connected to the preparator 102 and the cycler 106. In some embodiments, the first preparator disposable kit 302 is fluidly connected to the preparator 102 and the second preparator disposable kit 302. The second preparator disposable kit 302 can be fluidly connected to the first preparator disposable kit 302 and the cycler 106.
[0082] In use, the preparator 102 can be activated to begin filling the plurality of containers 406 with dialysis fluid, i.e., dialysate liquid, that has been generated by the 102, as described above. For example, the water treatment system 112 can purify a water source that can be used in the generation of the dialysis fluid. With the purified water, the proportioning system 114 can add dialysate concentrates (e.g., dextrose, glucose, ion concentrations, bicarbonate, combinations thereof, or some combination thereof) to the purified water to create the dialysis fluid, which is then transferred to the preparator disposable kit 302 via the inlet 402. In some embodiments, when the preparator 102 has created dialysis fluid sufficient for a first fill phase by the cycler 106, the controller 104 can control the cycler 106 to begin drawing fluid from the preparator disposable kit 302, In some embodiments, the fluid sufficient for the first fill phase by the cycler 106 can be determined, by the controller 104, when the first container of the plurality of containers 406 has been filled. By drawing fluid from the preparator disposable kit 302, the cycler 106 can be controlled to begin therapy before the fluid for the entire therapy has been generated by the preparator 102. Beginning therapy as soon as the first container of the plurality of containers 406 has been filled prevents the patient from having to wait for the rest of the dialysis fluid to be generated by the preparator 102, leading to less preparation time necessary before therapy can begin. Additionally, in some embodiments, the dialysis generation process can cause the fluid to maintain an elevated temperature such that the controller 104 may be able to skip heating the dialysis fluid before administering the dialysis fluid to the patient. In some embodiments, the fluid can be about 34°C to about 38°C as a result of the generation process. In some embodiments, the controller 104 can determine that the dialysis fluid requires a limited amount of heating time, as a result of residual heat from being recently generated by the preparator 102. In some embodiments, the preparator 102 can include a heater to facilitate the mixing of the dialysis fluid, to heat the dialysis fluid to allow the controller 104 to skip at least a portion of the heating of the dialysis fluid, or some combination thereof. As the therapy is ongoing using the dialysis19ACTIVE 717526587v2Attorney Docket No. 218079-023301 / PCT MozarcRef. No. IDF00016 PCT fluid from the first container of the plurality’ of containers 406, the preparator 102 can continue to generate additional dialysis fluid required for the remainder of the therapy. In some embodiments, the preparator 102 can fill all of the plurality of containers 406 required for the dialysis therapy before the therapy begins. In some embodiments, the controller 104 can alert the patient that sufficient fluid has been created by the preparator 102 and therapy can be started. In some embodiments, the controller 104 can alert the patient that sufficient fluid has been created by the preparator 102 such that, during the therapy, the patient will not need to wait for additional fluid to be generated by the preparator 102. For example, the dialysis system 100 can include an audio alert that therapy can begin.
[0083] In some embodiments, the controller 104 can adjust the dwell time of the cycler 106 to accommodate a delay in dialysis generation. For example, if the controller 104 determines that the fluid for the next fill phase will not be ready if it proceeds according to a known schedul e, the controller 104 can increase or extend the duration of the dwell phase to give the preparator 102 more time to generate dialysis fluid. In some embodiments, the controller 104 can adjust, e.g., reduce, subsequent dwell times to accommodate the delay while at least maintaining a total therapy time.
[0084] In some embodiments, the controller 104 can communi cate with the preparator 102, In some embodiments, the controller 104 can communicate with the preparator 102 to determine the status of the fluid generation. In some embodiments, the controller 104 can communicate with the preparator 102 to determine how much fluid has been generated. In some embodiments, the controller 104 can adjust the generation of fluid by the preparator 102 based on the observed status of the dialysis system 100. For example, the controller 104 can reduce the amount of fluid generated by the preparator 102 if the controller 104 determines that the remaining fill phases in the dialysis therapy will not require as much fluid as originally planned.
[0085] In some embodiments, to prevent having to wait for the preparator 102 to generate the dialysis fluid, the patient can connect a pre-filled container of dialysis fluid. The controller 104 can begin therapy using the pre-filled container of dialysis fluid. Simultaneously, the controller 104 can control the preparator 102 to generate the dialysis fluid for the remainder of the therapy. Connecting the pre-filled container of dialysis fluid20ACTIVE 717526587v2Attorney Docket No. 218079-023301 / PCT MozarcRef. No. IDF00016 PCT can allow a patient to immediately begin the dialysis treatment while the preparator 102 creates the dialysis fluid for the remainder of the therapy, thereby allowing the patient to only have to store the first container of the plurality of containers 406. In some embodiments, the preparator 102 can generate a plurality' of containers 406 filled w’ith dialysis fluid which can later be used as the pre-filled container of dialysis fluid. This can permit the patient to create bags of dialysis fluid in their home.
[0086] By creating bags of dialysis fluid in their home, when it will be used in a dialysis therapy, the patients can forgo having large amounts of dialysis fluid transported and stored at their point of care, e.g., their house. The dialysis fluid created by the preparator 102 can, in some embodiments, be from a powder which dramatically reduces the storage burden on the patient,
[0087] In some embodiments, the preparator 102 can include a first preparator disposable kit 302 and the cycler 106 can include a second preparator disposable kit 302 which are fluidly disconnected. For example, the first preparator disposable kit 302 can be fluidly isolated from the cycler 106 of the dialysis system 100, Without the necessity of being fluidly connected, the preparator 102 can located away from the cycler 106. This can be advantageous as the generation of dialysis fluid can be an audible process, which can cause an annoyance to the patient. The patients can choose to generate the dialysis fluid at one location while administering the dialysis fluid at a second location. For example, the preparator 102 can be set up in a patient’s garage while the cycler 106 can be next to a chair or their bed, where the patients receive their treatment. This can be preferable as the generation of dialysis fluid can be a noisy process, which can cause an annoyance to the patient. Once the dialysis fluid is created by the preparator 102, the patient can attach the plurality of containers 406 to the cycler 106 where the patient receives the therapy. This can allow, in some embodiments, the patient to create the dialysis fluid at one location where the noise may be less of a concern and administer the dialysis fluid at a second location. Additionally, any alarms from the preparator 102 will not be heard by the patient during therapy, allowing the patient to address the issues at a later time. As therapy can be administered at night while the patient is sleeping, avoiding the alarms can allow the patient to get more rest.21ACTIVE 717526587v2Attorney Docket No. 218079-023301 / PCT MozarcRef. No. IDF00016 PCT
[0088] The terminology used herein is intended to describe embodiments and is not intended to be limiting. The terms “a,” “an,” and “the” include the plural forms as well, unless clearly indicated otherwise. The terms “comprises” and / or “comprising,” when used in this Specification, specify the presence of the stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, and / or components.
[0089] It is to be understood that changes may be made in detail, especially in matters of the construction materials employed and the shape, size, and arrangement of parts without departing from the scope of the present disclosure. This Specification and the embodiments described are examples, with the true scope and spirit of the disclosure being indicated by the claims that follow.22ACTIVE 717526587v2
Claims
Attorney Docket No. 218079-023301 / PCT MozarcRef. No. IDF00016 PCT CLAIMSWhat is claimed is:
1. A dialysis system, comprising:a water treatment system configured to purify a source water;a preparator configured to provide a dialysis fluid,a disposable kit comprising:an inlet configured to be fluidly connected to the preparator, wherein the inlet is configured to receive the dialysis fluid, components of the dialysis fluid, water, or any combination thereof from the preparator;an outlet configured to be connected to a cycler;a plurality of containers,wherein the plurality of containers are configured to be fluidly connected to the inlet;wherein the plurality of containers are configured to be fluidly connected to the outlet;a plurality of valves fluidly disposed between the inlet and the outlet; wherein the plurality of valves are configured to selectively control fluid flow to the plurality of containers; andan ultrafilter fluidly disposed between the plurality of valves and the inlet; a sensor configured to determine a first amount of the dialysis fluid in a first of the plurality of containers; anda controller configured to control the water treatment system, the preparator, and the plurality of valves in the disposable kit;wherein the controller is configured to control the plurality of valves using the first amount of the dialysis fluid in the first of the plurality of containers as sensed.
2. The dialysis system of claim 1, wherein the controller is configured to control the plurality of valves to fill the first of the plurality of containers; and in response to completing filling23ACTIVE 717526587v2Attorney Docket No. 218079-023301 / PCT MozarcRef. No. IDF00016 PCT of the first of the plurality of containers, the controller is configured to control the plurality of valves to fill a second of the plurality of containers.
3. The dialysis system of claim 1, wherein the controller is configured to control the plurality of valves to fill the plurality of containers concurrently.
4. The dialysis system of claim 1, wherein the controller is configured to control the preparator to fill the plurality of containers; andin response to the plurality of containers being filled, the controller is configured to enable a cycler to perform the dialysis therapy.
5. The dialysis system of claim 1, wherein the controller is configured to control the preparator to fill the first of the plurality of containers; andin response to the first of the plurality of containers being filled, the controller is configured to enable a cycler to perform the dialysis therapy.
6. The dialysis system of claim 1, wherein the controller is configured to control the preparator to fill the first of the plurality of containers; andwherein the controller is configured to concurrently enable a cycler to perform the dialysis therapy.
7. The dialysis system of claim 1, further comprising a drain fluidly connected to the disposable kit;wherein in response to determining a composition of the dialysis fluid does not meet a defined composition, the controller is configured to direct the dialysis fluid to the drain.
8. The dialysis system of claim 1, further comprising a second filter fluidly disposed between the filter and the plurality of containers.
9. The dialysis system of claim 1, wherein the system comprises a heater configured to heat the dialysis fluid, water, components of the dialysis fluid, or any combination thereof.24ACTIVE 717526587v2Attorney Docket No. 218079-023301 / PCT MozarcRef. No. IDF00016 PCT10. The dialysis system of claim 1, wherein the sensor comprises a plurality of sensors; wherein each of the plurality of sensors is configured to determine a respective amount of the dialysis fluid in each of the plurality of containers.
11. A disposable kit configured for use in a dialysis system, comprising:an inlet configured to receive a dialysis fluid from a preparator of the dialysis system,an outlet configured to be connected to a cycler of the dialysis system; a plurality of containers,wherein the plurality of containers are configured to be fluidly connected to the inlet;wherein the plurality of containers are configured to be fluidly connected to the outlet;a plurality of valves fluidly disposed between the inlet and the outlet; wherein the plurality of valves are configured to selectively control fluid flow to the plurality of containers; anda filter fluidly disposed between the plurality of valves and the inlet, the filter configured to remove endotoxin and bacteria.
12. The disposable kit of claim 11, wherein the dialysis fluid comprises a mixture comprising purified water and one or more dialysis concentrates.
13. The disposable kit of claim 11, further comprising a second filter fluidly disposed between the filter and the plurality of containers.
14. The disposable kit of claim 11, wherein a first portion of the plurality of containers is configured to be filled; and a second portion of the plurality of containers is configured to be filled in response to completion of the first portion of the plurality of containers being filled.25ACTIVE 717526587v2Attorney Docket No. 218079-023301 / PCT MozarcRef. No. IDF00016 PCT 15. The disposable kit of claim 11, wherein a first container of the plurality of containers and a second container of the plurality of containers is configured to be filled concurrently.26ACTIVE 717526587v2