Peritoneal dialysis cycler

Abstract

A system includes a dialysis fluid pump. The system includes an input interface device configured to receive a plurality of inputs defining a peritoneal dialysis therapy for a patient. The system includes a controller configured to adapt the peritoneal dialysis therapy for the patient. The controller determines a number of total cycles for the therapy for the patient, determine an amount of ultrafiltration per cycle for the therapy for the patient, and determine a maximum reserve volume for the therapy for the patient wherein the number of total cycles is an integer N; wherein a number of tidal cycles within the number of total cycles is N-1 The maximum reserve volume is an amount of fluid reserved in each of the cycles. The controller is configured to control the therapy for the patient to retain the maximum reserve volume for each of the cycles.

Description

PERITONEAL DIALYSIS CYCLERCROSS REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority to and the benefit of Indian Provisional Application No. 202411051885, filed July 6, 2024, and Indian Provisional Application No. 202411051886, filed July 6, 2024, the contents of which is hereby incorporated by reference in its entirety.FIELD

[0002] This disclosure relates generally to dialysis systems. More particularly, this disclosure relates to dialysis systems including variable drain volumes in a multi-cycle dialysis therapy.BACKGROUND

[0003] Dialysis systems can be used to treat patients with kidney disorders. There are a number of dialysis systems in use in the health care industry. Dialysis fluids that are specifically controlled for the dialysis systems are used in these dialysis systems for treatment of the patients.SUMMARY

[0004] In some embodiments, a system includes a dialysis fluid pump; an input interface device configured to receive a plurality of inputs defining a peritoneal dialysis therapy for a patient; and a controller configured to adapt the peritoneal dialysis therapy for the patient. In some embodiments, the controller is configured to determine a first fluid reserve volume for a first set of cycles of a plurality of cycles; and determine a second fluid reserve volume for a second set of cycles of the plurality of cycles. In some embodiments, the first fluid reserve volume is different than the second fluid reserve volume.

[0005] In some embodiments, a system, the first fluid reserve volume is greater than the second fluid reserve volume.

[0006] In some embodiments, the system includes a third set of cycles of the plurality of cycles. In some embodiments, the third set of cycles of the plurality of cycles has a third fluid reserve volume. In some embodiments, the third fluid reserve volume is different than the first fluid reserve volume or the second fluid reserve volume.

[0007] In some embodiments, the second fluid reserve volume is greater than the third fluid reserve volume.

[0008] In some embodiments, the plurality of cycles includes a fixed number of cycles.

[0009] In some embodiments, the plurality of cycles includes a variable number of cycles that is increasable in response to the plurality of inputs defining the peritoneal dialysis therapy for the patient.

[0010] In some embodiments, the first fluid reserve volume is a maximum reserve volume and the second fluid reserve volume is the maximum reserve volume minus a constant amount determined using the maximum reserve volume, a minimum reserve volume, and a number of cycles.

[0011] In some embodiments, the first fluid reserve volume is a minimum reserve volume and the second fluid reserve volume is the minimum reserve volume plus constant amount determined using the minimum reserve volume, a maximum reserve volume, and a number of cycles.

[0012] In some embodiments, a full drain is completed between the first set of cycles of the plurality of cycles and the second set of cycles of the plurality of cycles.

[0013] In some embodiments, the plurality of inputs defining the peritoneal dialysis therapy for the patient include a maximum reserve volume, a minimum reserve volume, a full drain frequency, and a reserve volume setting. In some embodiments, the reserve volume setting includes a decremental reserve volume setting and an incremental reserve volume setting.

[0014] In some embodiments, a method includes receiving, by a controller of a peritoneal dialysis system, a plurality of inputs defining a peritoneal dialysis therapy for a patient. In some embodiments, the controller is adapted to customize the peritoneal dialysis therapy for the patient. In some embodiments, the method includes calculating, by the controller, a first fluid reserve volume for a first set of cycles of a plurality of cycles. In some embodiments, the method includes calculating, by the controller, a second fluid reserve volume for a second set of cycles of the plurality of cycles. In some embodiments, the second fluid reserve volume is different than the first fluid reserve volume. In some embodiments, the method includes controlling, by the controller, a dialysis fluid pump using the first fluid reserve volume and the second fluid reserve volume.

[0015] In some embodiments, the first fluid reserve volume is greater than the second fluid reserve volume.

[0016] In some embodiments, the method includes calculating, by the controller, a third fluid reserve volume for a third set of cycles of the plurality of cycles. In some embodiments, the third fluid reserve volume is different than the first fluid reserve volume or the second fluid reserve volume.

[0017] In some embodiments, the second fluid reserve volume is greater than the third fluid reserve volume.

[0018] In some embodiments, the plurality of cycles includes a fixed number of cycles.

[0019] In some embodiments, the plurality of cycles includes a variable number of cycles.In some embodiments, the method includes increasing a total number of cycles in response to the plurality of inputs defining the peritoneal dialysis therapy for the patient.

[0020] In some embodiments, calculating, by the controller, the first fluid reserve volume for the first set of cycles of the plurality of cycles includes setting the first fluid reserve volume to be equal to a maximum reserve volume.

[0021] In some embodiments, the method includes calculating, by the controller, a constant amount by which to modify the first fluid reserve volume using the maximum reserve volume, a minimum reserve volume, a number of cycles, and a full drain frequency.

[0022] In some embodiments, calculating, by the controller, the second fluid reserve volume for the second set of cycles of the plurality of cycles includes subtracting the constant amount from the first fluid reserve volume.

[0023] In some embodiments, calculating, by the controller, the first fluid reserve volume for the first set of cycles of the plurality of cycles includes setting the first fluid reserve volume to be equal to the minimum reserve volume. In some embodiments, calculating, by the controller, the second fluid reserve volume for the second set of cycles of the plurality of cycles includes adding the constant amount to the first fluid reserve volume.

[0024] In some embodiments, a system includes a dialysis fluid pump; an input interface device configured to receive a plurality of inputs defining a peritoneal dialysis therapy for a patient; and a controller configured to adapt the peritoneal dialysis therapy for the patient. In some embodiments, the controller is configured to determine a number of total cycles for the peritoneal dialysis therapy for the patient; determine an amount of ultrafiltration per cycle forthe peritoneal dialysis therapy for the patient; determine a maximum reserve volume for the peritoneal dialysis therapy for the patient. In some embodiments, the number of total cycles in an integer N and a number of tidal cycles within the number of total cycles is N-l. In some embodiments, the controller is configured to control the peritoneal dialysis therapy for the patient to retain the maximum reserve volume for each of the tidal cycles. In some embodiments, the maximum reserve volume is an amount of fluid reserved in each of the tidal cycles.

[0025] In some embodiments, the maximum reserve volume is determined using a maximum volume per cycle, a night fill volume, and an amount of ultrafiltration per cycle.

[0026] In some embodiments, the maximum reserve volume is constant for each of the tidal cycles.

[0027] In some embodiments, the number of total cycles is fixed.

[0028] In some embodiments, the number of total cycles is determined using a total therapy volume of a treatment and a fill volume per cycle.

[0029] In some embodiments, a full drain is completed after completing the number of tidal cycles.

[0030] In some embodiments, the plurality of inputs defining the peritoneal dialysis therapy for the patient include a night fill volume, a total therapy volume, an estimated ultrafiltration, and a maximum volume per cycle.

[0031] In some embodiments, during a drain part of each of the tidal cycles, the maximum reserve volume is retained in a cavity of the patient.

[0032] In some embodiments, the controller is configured to retain a number of cycles, a night fill volume, and a dwell time as fixed parameters.

[0033] In some embodiments, a method includes receiving, by a controller of a peritoneal dialysis system, a plurality of inputs defining a peritoneal dialysis therapy for a patient. In some embodiments, the controller is adapted to customize the peritoneal dialysis therapy for the patient. In some embodiments, the method includes calculating, by the controller, a number of total cycles for the peritoneal dialysis therapy for the patient. In some embodiments, the number of total cycles is an integer N and a number of tidal cycles within the number of total cycles is N-l. In some embodiments, the method includes calculating, by the controller, an amount of ultrafiltration per cycle for the peritoneal dialysis therapy for the patient. In someembodiments, the method includes calculating, by the controller, a maximum reserve volume for the peritoneal dialysis therapy for the patient. In some embodiments, the maximum reserve volume is an amount of fluid reserved in each of the tidal cycles. In some embodiments, the method includes controlling, by the controller, the peritoneal dialysis therapy for the patient to retain the maximum reserve volume for each of the tidal cycles.

[0034] In some embodiments, calculating, by the controller, the maximum reserve volume includes using a maximum volume per cycle, a night fill volume, and an amount of ultrafiltration per cycle.

[0035] In some embodiments, controlling, by the controller, the peritoneal dialysis therapy for the patient to retain the maximum reserve volume for each of the tidal cycles includes setting the maximum reserve volume to be a constant volume for each of the tidal cycles.

[0036] In some embodiments, the method includes controlling, by the controller, the peritoneal dialysis therapy for the patient to include a full drain after completing the number of tidal cycles.

[0037] In some embodiments, the plurality of inputs defining the peritoneal dialysis therapy for the patient include a night fill volume, a total therapy volume, an estimated ultrafiltration, and a maximum volume per cycle.

[0038] In some embodiments, controlling, by the controller, the peritoneal dialysis therapy for the patient includes retaining the maximum reserve volume in a cavity of the patient.

[0039] In some embodiments, the method includes fixing, by the controller, the number of cycles, a night fill volume, and a dwell time for the peritoneal dialysis therapy for the patient.

[0040] In some embodiments, the method includes controlling, by the controller, a drain portion of each tidal cycle to end when an estimated peritoneal volume equals the maximum reserve volume.

[0041] In some embodiments, in response to the estimated peritoneal volume equaling the maximum reserve volume, terminating the drain portion of a respective tidal cycle and initiating a fill portion of a next cycle.

[0042] In some embodiments, a non-transitory computer readable storage medium storing instructions for a controller that, when executed, cause the controller to perform a method. In some embodiments, the method includes receiving, by a controller of a peritoneal dialysis system, a plurality of inputs defining a peritoneal dialysis therapy for a patient. In someembodiments, the controller is adapted to customize the peritoneal dialysis therapy for the patient. In some embodiments, the method includes calculating, by the controller, a number of total cycles for the peritoneal dialysis therapy for the patient. In some embodiments, the number of total cycles is an integer N and a number of tidal cycles within the number of total cycles is N-l. In some embodiments, the method includes calculating, by the controller, an amount of ultrafiltration per cycle for the peritoneal dialysis therapy for the patient. In some embodiments, the method includes calculating, by the controller, a maximum reserve volume for the peritoneal dialysis therapy for the patient. In some embodiments, the maximum reserve volume is an amount of fluid reserved in each of the tidal cycles. In some embodiments, the method includes controlling, by the controller, the peritoneal dialysis therapy for the patient to retain the maximum reserve volume for each of the tidal cycles.

[0043] In some embodiments, calculating, by the controller, the maximum reserve volume includes using a maximum volume per cycle, a night fill volume, and an amount of ultrafiltration per cycle.

[0044] In some embodiments, a system includes a dialysis fluid pump; an input interface device configured to receive a plurality of inputs defining a peritoneal dialysis therapy for a patient; and a controller configured to adapt the peritoneal dialysis therapy for the patient. In some embodiments, the controller is configured to determine a number of total cycles for the peritoneal dialysis therapy for the patient. In some embodiments, the number of total cycles is an integer N and a number of tidal cycles within the number of total cycles is N-l. In some embodiments, the controller is configured to determine an amount of ultrafiltration per cycle for the peritoneal dialysis therapy for the patient; determine a maximum reserve volume for the peritoneal dialysis therapy for the patient; and control the peritoneal dialysis therapy for the patient to retain a target reserve volume for each of the tidal cycles. In some embodiments, the maximum reserve volume is an amount of fluid reserved in each of the tidal cycles.

[0045] In some embodiments, the maximum reserve volume is determined using a maximum volume per cycle, a night fill volume, and an amount of ultrafiltration per cycle.

[0046] In some embodiments, the target reserve volume is input by an operator.In some embodiments, in response to determining the target reserve volume is greater than the maximum reserve volume, the controller is configured to control the peritoneal dialysis therapy for the patient to retain the maximum reserve volume for each of the cycles.BRIEF DESCRIPTION OF THE DRAWINGS

[0047] 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.

[0048] FIG. 1 is a schematic diagram of a dialysis system, according to some embodiments.

[0049] FIG. 2 shows a schematic diagram of the cycler of FIG. 1, according to some embodiments.

[0050] FIG. 3 shows a flowchart for a method of varying a reserve volume in a dialysis therapy, according to some embodiments.

[0051] FIG. 4 shows a therapy graph in which a reserve volume is varied in a dialysis therapy, according to some embodiments.

[0052] FIG. 5 shows a flowchart for a method of varying a maximum reserve volume in a dialysis therapy, according to some embodiments.

[0053] FIG. 6 shows a therapy graph in which a maximum reserve volume is varied in a dialysis therapy, according to some embodiments.

[0054] Like reference numbers represent the same or similar parts throughout.DETAILED DESCRIPTION

[0055] 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). Some patients can experience “drain pain” during the drain phase. This typically occurs when the entire volume of fluid is drained from the patient in a particular cycle.

[0056] Embodiments of this disclosure are directed to systems and methods for automatically controlling a dialysis therapy dynamically for a patient while maintaining a defined reserve volume. As used herein, the “reserve volume” includes an amount of dialysis fluid that is not removed from the patient during the drain phase. In some embodiments, a maximum reserve volume can be determined based on inputs from an operator for the particular therapy. In some embodiments, the cycler may be operable in multiple modes ofoperation, including a continuous cycling peritoneal dialysis mode (in which a full drain is performed) and a tidal therapy mode in which the reserve volume may be varied. In some embodiments, the cycler may be operable in multiple modes of operation, including a continuous cycling peritoneal dialysis mode (in which a full drain is performed) and a tidal therapy mode in which the reserve volume is maintained. In some embodiments, the reserve volume may be set at a first value for a first set of cycles and then incremented or decremented for a second set of cycles. In some embodiments, the operator may be able to select between the continuous cycling peritoneal dialysis mode and the tidal therapy mode. As used herein, a “cycle” can include an injection phase, a dwell phase, and a drain phase. In some embodiments, a “tidal cycle” can include an injection phase, a dwell phase, and a drain phase in which the reserve volume is maintained.

[0057] 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.

[0058] The illustrated embodiment includes a dialysis fluid preparation system 102. A controller 104 is configured to be in electronic communication with the dialysis fluid preparation system 102 to send and receive communications relating to sensed parameters, control of valves, or the like. The dialysis fluid preparation system 102 can be fluidly connected to a cycler 106. The cycler 106 can be fluidly connected with a patient to perform the dialysis treatments.

[0059] The cycler 106 can be configured to inject the dialysis fluid into the patient and drain the dialysis fluid when the treatment is complete. The cycler 106 can receive a prepared dialysis fluid from the dialysis fluid preparation system 102. The cycler 106 can be in electronic communication with the controller 104 to accomplish the necessary treatments for the patient.

[0060] In some embodiments, the dialysis fluid preparation system 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 dialysis fluid preparation system 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 andcombined 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 can be in electronic communication with the cycler 106 to accomplish the necessary treatments for the patient.

[0061] It is to be appreciated that the cycler 106 can include one or more additional features such as, but not limited to, a user interface configured to receive user inputs, display outputs for the user, or any combination thereof.

[0062] The controller 104 can be in wired or wireless communication with the dialysis fluid preparation system 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.

[0063] 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).

[0064] 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 the 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.

[0065] 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 is configured to modify a peritoneal dialysis therapy of a patient based on 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 and can include a mode of operation such as continuous cycling peritoneal dialysis mode and a tidal therapy mode.

[0066] In some embodiments, the one or more inputs can include one or more of a maximum reserve volume, a minimum reserve volume, a full drain frequency, a night fill volume, a total therapy volume, an estimated ultrafiltration, a maximum volume per cycle, and a reserve volume setting. In some embodiments, the operator can additionally enter a target or minimum reserve volume in an instance where a particular value is known for the patient based on historical treatments, from a positron emission tomography (PET) scan, from clinician experience, or combinations thereof. In some embodiments, if the target reserve volume is greater than the maximum reserve volume, the maximum reserve volume can be used to control the dialysis therapy of the patient. In some embodiments, if the target reserve volume is less than the maximum reserve volume, the target reserve volume may be used instead of the maximum reserve volume when controlling the dialysis therapy of the patient.

[0067] In some embodiments, the at least one processor 150 can calculate a total number of cycles, an ultrafiltration per cycle, and a maximum reserve volume based on the inputs. In some embodiments, the reserve volume setting can include at least one of a decremental reserve volume setting and an incremental reserve volume setting. In some embodiments, an operator of the cycler 106 can enter the information into the control panel 154 and the information can be stored in the memory 152 for use by the at least one processor 150 in controlling the dialysis therapy of the patient.

[0068] In some embodiments, the at least one processor 150 can use the inputs defining the peritoneal dialysis therapy of the patient to control one or more settings such as, but not limited to, a reserve volume for the dialysis therapy. In some embodiments, the at least one processor 150 is configured to divide a total number of cycles into sets of cycles.

[0069] The at least one processor 150 can be further configured to set a reserve volume for each of the sets of cycles. In some embodiments, a first reserve volume for a first set of cycles is different than a second reserve volume for a second set of cycles. In some embodiments, the first reserve volume can be greater than the second reserve volume. In some embodiments, the first reserve volume can be less than the second reserve volume. In some embodiments, whether the first reserve volume is greater than or less than the second reserve volume can be determined based on whether the reserve volume setting entered by the operator was a decremental reserve volume setting (first reserve volume is greater than the second reserve volume) or an incremental reserve volume setting (first reserve volume is less than the second reserve volume). As a result, the at least one processor 150 can be configured to control the dialysis fluid pump 160 so that the first reserve volume is maintained in the peritoneal cavityfor cycles within the first set of cycles and then to maintain the second reserve volume in the peritoneal cavity for cycles within the second set of cycles. In some embodiments, the last cycle of each of the sets of cycles can be configured to perform a complete drain. That is, the last cycle of each of the sets of cycles does not maintain the reserve volume in the peritoneal cavity.

[0070] It is to be appreciated that there may be more than two sets of cycles in the dialysis therapy and that the above is an example including two sets of cycles. For example, in some embodiments, there may be three, four, or more sets of cycles in the dialysis therapy. In some embodiments, when a third set of cycles is present, a third reserve volume can be set by the at least one processor 150. In some embodiments, the third reserve volume is different than the first reserve volume or the second reserve volume. In some embodiments, the at least one processor 150 is configured to set the third reserve volume to be greater than the second reserve volume when an incremental reserve volume setting was input or to be less than the second reserve volume when a decremental reserve volume setting was input.

[0071] In some embodiments, the input settings can include a number of cycles, a full drain frequency, an incremental or decremental reserve volume setting, a maximum reserve volume amount, and a minimum reserve volume amount. In some embodiments, the at least one processor 150 is configured to determine a number of sets by dividing the number of cycles by the full drain frequency as shown in the following equation.Number of cycles

[0072] Number of sets = Full drain frequency

[0073] In some embodiments, there may be a remainder if the division does not result in a whole number of sets. In cases in which a remainder is present, the remainder is equal to the number of remaining cycles not falling within a complete set. In such cases, the cycles not falling within a complete set will use the reserve volume from the previous set. That is, the incomplete set will not increment or decrement relative to the prior set if the number of cycles in the set does not form a complete set. In some embodiments, the at least one processor 150 is configured to determine a difference x between sets using the following equation:

[0075] In some embodiments, the difference x between sets can alternatively be calculated by averaging the maximum reserve volume and the minimum reserve volume.

[0076] In some embodiments, the at least one processor 150 can then compute the first reserve volume, the second reserve volume, and the like, using the following example in Table 1 :

[0077] Table 1

[0078] In the above example, a, b, and c are integers. It is to be appreciated that the total number of sets and the number of cycles can vary according to the particular patient and dialysis therapy settings.

[0079] In some embodiments, the inputs can include a total therapy volume, a fill volume, an estimated peritoneal volume post dwell, a full drain frequency, a maximum reserve volume, and a minimum reserve volume.

[0080] In some embodiments, the maximum reserve volume and the minimum reserve volume can be entered as a percentage of the fill volume. For example, in some embodiments, the maximum or the minimum reserve volume can be selected to be from 5% to 60% of the fill volume. It is to be appreciate that these percentages are examples and that actual percentages can vary beyond the stated values.

[0081] In some embodiments, the at least one processor 150 is configured to modify the reserve volume across the sets of cycles of the patient’s dialysis therapy without modifying a total number of cycles. That is, in some embodiments, the total number of cycles is fixed by the user inputs and is not varied by the at least one processor 150. In some embodiments, the number of cycles can be variable. In some embodiments, the number of cycles can be decreased by the at least one processor 150. In some embodiments, the number of cycles can be increased by the at least one processor 150.

[0082] In some embodiments, the selection of the incremental reserve volume setting or the decremental reserve volume setting can be selected based on a particular patient and the patient’s specific drain pain. It is to be appreciated that in some embodiments, the cycler 106 can also include an operating mode in which the reserve volume is not modified across each set.

[0083] In some embodiments, the at least one processor 150 can use the inputs defining the peritoneal dialysis therapy of the patient to control one or more settings such as, but not limited to, a maximum reserve volume for the dialysis therapy. In some embodiments, the at least one processor 150 is configured to determine a number of cycles for the dialysis therapy using the following equation:Total therapy volume

[0084] Number of cycles =Night Fill volume

[0085] The total therapy volume is an integer entered by the operator (e.g., a clinician) representing a total therapy volume for the treatment in milliliters (mL). The night fill volume is an integer entered by the operator representing an amount of dialysis fluid in mL to be injected into the peritoneal cavity of the patient.

[0086] In some embodiments, the at least one processor 150 is configured to determine an amount of ultrafiltration per cycle using the following equation:Estimated ultrafiltration volume

[0087] Ultrafiltration per cycle =Number of cycles

[0088] The estimated ultrafiltration volume per cycle is an integer value in mL. The estimated ultrafiltration volume is an integer value in mL entered by the operator.

[0089] In some embodiments, the at least one processor 150 is configured to determine a maximum reserve volume using the following equation:

[0090] Maximum reserve volume = Maximum peritoneal volume — Fill volume + Ultrafiltration per cycle)

[0091] The maximum reserve volume is an integer value in mL. The maximum peritoneal volume is an integer value in mL entered by the operator. The ultrafiltration per cycle is an integer value in mL as determined using the equation discussed above. In some embodiments, the maximum reserve volume is constant for each of the tidal cycles.

[0092] In some embodiments, using the determined maximum reserve volume, the at least one processor 150 is configured to control the dialysis therapy so that the maximum reservevolume is maintained in the peritoneal cavity at the end of each drain phase in a tidal cycle. In some embodiments, the at least one processor 150 can be configured to periodically perform a complete drain. In some embodiments, the operator can enter the number of cycles at which a complete drain is performed.

[0093] In some embodiments, the at least one processor 150 can control the dialysis therapy so that a target reserve volume is maintained in the peritoneal cavity. In such embodiments, the target reserve volume can be entered by the operator. In such embodiments, if the target reserve volume is greater than the maximum reserve volume, the at least one processor 150 can be configured to rely instead upon the maximum reserve volume, overriding the target reserve volume. In some embodiments, when the target reserve volume is less than the maximum reserve volume, the target reserve volume can be used to control the dialysis therapy.

[0094] In some embodiments, the at least one processor 150 is configured to control the dialysis therapy using the maximum reserve volume or the target reserve volume across the without modifying a total number of cycles. That is, in some embodiments, the total number of cycles is fixed after determination using the user inputs and is not varied by the at least one processor 150.

[0095] FIG. 3 shows a flowchart for a method 200 of varying a reserve volume in a dialysis therapy, according to some embodiments. The method 200 can be performed by the cycler 106 (FIG. 1 and FIG. 2) to conduct a dialysis treatment for a patient. In some embodiments, the method 200 can be less painful to the patient by varying reserve volumes and reducing drain pain felt by the patient. In some embodiments, the method 200 can also be used to identify a drain pain limit at which a patient is not feeling drain pain, but any further changes would result in drain pain. The drain pain limit can be used in subsequent therapies to control the reserve volume settings.

[0096] At block 202, the method 200 includes receiving, by a controller (e.g., the at least one processor 150 of the cycler 106 in FIG. 1 and FIG. 2) of a peritoneal dialysis system (e.g., the dialysis system 100 of FIG. 1), a plurality of inputs defining a peritoneal dialysis therapy for a patient. In some embodiments, the controller is adapted to customize the peritoneal dialysis therapy for the patient using the plurality of inputs.

[0097] At block 204, the method 200 includes calculating, by the controller, a first fluid reserve volume for a first set of cycles of a plurality of cycles.

[0098] At block 206 the method 200 includes calculating, by the controller, a second fluid reserve volume for a second set of cycles of the plurality of cycles. In some embodiments, the second fluid reserve volume is different than the first fluid reserve volume. In some embodiments, the first fluid reserve volume is greater than the second fluid reserve volume (a decremental reserve volume setting was entered). In some embodiments, the first fluid reserve volume is less than the second fluid reserve volume (an incremental reserve volume setting was entered).

[0099] At block 208 the method 200 includes controlling, by the controller, a dialysis fluid pump using the first fluid reserve volume and the second fluid reserve volume.

[0100] FIG. 4 shows a therapy graph 250 in which a reserve volume is varied in a dialysis therapy, according to some embodiments.

[0101] In the illustrated therapy graph 250, the therapy includes four sets of cycles, including first cycle set 252, second cycle set 254, third cycle set 256, and fourth cycle set 258. Each of the sets of cycles includes five cycles 260. The cycles in which a reserve volume is maintained can be referred to as “tidal cycles.” The last of the five cycles 260 includes a full drain. In the illustrated therapy graph 250, the therapy shown includes a decremental reserve volume in which the first reserve volume 262 is greater than the second reserve volume 264, which is greater than the third reserve volume 266, which is greater than the fourth reserve volume 268. Table 2 below shows the specific fill volumes, estimated peritoneal volume post dwell, drain volume, and reserve volume for each cycle. As is illustrated, the drain volume in the final cycle of any set is a complete drain (i.e., no reserve volume) as the last cycle will perform a complete drain. Additionally, the first cycle of every set will include a full fill.

[0102] Table 2

[0103] It is to be appreciated that the illustrated therapy graph 250 and the data included in Table 2 are for example purposes. The exact values and the corresponding illustrated therapy graph 250 can vary based on a particular patient’s needs.

[0104] FIG. 5 shows a flowchart for a method 500 of controlling a dialysis therapy, according to some embodiments. The method 500 can be performed by the cycler 106 (FIG. 1and FIG. 2) to conduct a dialysis treatment for a patient. In some embodiments, the method 500 can be less painful to the patient by reducing drain pain felt by the patient.

[0105] At block 502, the method 500 includes receiving, by a controller of a peritoneal dialysis system, a plurality of inputs defining a peritoneal dialysis therapy for a patient. In some embodiments, the controller is adapted to customize the peritoneal dialysis therapy for the patient.

[0106] The one or more inputs can include one or more inputs defining a peritoneal dialysis therapy for a patient and can include a mode of operation such as continuous cycling peritoneal dialysis mode and a tidal therapy mode. In some embodiments the one or more inputs can include one or more of a night fill volume, a total therapy volume, an estimated ultrafiltration, and a maximum volume per cycle. In some embodiments, the operator can additionally enter a target or minimum reserve volume in an instance where a particular value is known for the patient based on historical treatments.

[0107] At block 504, the method 500 includes calculating, by the controller, a number of total cycles for the peritoneal dialysis therapy for the patient.

[0108] In some embodiments, the at least one processor 150 is configured to determine a number of cycles for the dialysis therapy using the following equation:Total therapy volume

[0109] Number of total cycles =Night Fill volume

[0110] The total therapy volume is an integer entered by the operator (e.g., a clinician) representing a total therapy volume for the treatment in milliliters (mL). The night fill volume is an integer entered by the operator representing an amount of dialysis fluid in mL to be injected into the peritoneal cavity of the patient.[oni] At block 506, the method 500 includes calculating, by the controller, an amount of ultrafiltration per cycle for the peritoneal dialysis therapy for the patient.

[0112] In some embodiments, the at least one processor 150 is configured to determine an amount of ultrafiltration per cycle using the following equation:Estimated ultrafiltration volume

[0113] Ultrafiltration per cycle =Number of cycles

[0114] The estimated ultrafiltration volume per cycle is an integer value in mL. The estimated ultrafiltration volume is an integer value in mL entered by the operator.

[0115] At block 508, the method includes calculating, by the controller, a maximum reserve volume for the peritoneal dialysis therapy for the patient. In some embodiments, the maximum reserve volume is an amount of fluid reserved in each of the tidal cycles.

[0116] In some embodiments, the at least one processor 150 is configured to determine a maximum reserve volume using the following equation:

[0117] Maximum reserve volume = Maximum peritoneal volume — Fill volume + Ultrafiltration per cycle)

[0118] The maximum reserve volume is an integer value in mL. The maximum peritoneal volume is an integer value in mL entered by the operator. The ultrafiltration per cycle is an integer value in mL as determined using the equation discussed above.

[0119] At block 510, the method 500 includes controlling, by the controller, the peritoneal dialysis therapy for the patient to retain the maximum reserve volume for each of the tidal cycles. In some embodiments, if a target reserve volume is entered, block 510 can include determining whether the target reserve volume is less than the maximum reserve volume and, if less, the controller can control the peritoneal dialysis therapy for the patient to retain the target reserve volume instead of the maximum reserve volume.

[0120] FIG. 6 shows a therapy graph 650 in which a reserve volume is set for a dialysis therapy, according to some embodiments.

[0121] In the illustrated therapy graph 650, the therapy includes ten cycles 652. The first four of the cycles 652 are set to stop draining at a maximum reserve volume 654 (i.e., are tidal cycles). Additionally, each of the cycles 652 is configured to not exceed the maximum peritoneal volume 656. In the illustrated embodiment, a complete drain is performed after the fifth of the cycles 652 (i.e., not a tidal cycle) and at the conclusion of the dialysis therapy (e.g., after the tenth of the cycles 652). Table 3 below shows the specific data illustrated in FIG. 6.

[0122] Table 3

[0123] It is to be appreciated that the illustrated therapy graph 650 and the data included in Table 3 are for example purposes. The exact values and the corresponding illustrated therapy graph 650 can vary based on a particular patient’s needs.

[0124] 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.

[0125] 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 embodimentsdescribed are examples, with the true scope and spirit of the disclosure being indicated by the claims that follow.

Claims

CLAIMS1. A system comprising: a dialysis fluid pump; an input interface device configured to receive a plurality of inputs defining a peritoneal dialysis therapy for a patient; and a controller configured to adapt the peritoneal dialysis therapy for the patient, wherein the controller is configured to: determine a number of total cycles for the peritoneal dialysis therapy for the patient, wherein the number of total cycles is an integer N; wherein a number of tidal cycles within the number of total cycles is N-l; determine an amount of ultrafiltration per cycle for the peritoneal dialysis therapy for the patient; determine a maximum reserve volume for the peritoneal dialysis therapy for the patient, wherein the maximum reserve volume is an amount of fluid reserved in each of the tidal cycles; and control the peritoneal dialysis therapy for the patient to retain the maximum reserve volume for each of the tidal cycles.

2. The system of claim 1, wherein the maximum reserve volume is determined using a maximum volume per cycle, a night fill volume, and an amount of ultrafiltration per cycle.

3. The system of claim 1, wherein the maximum reserve volume is constant for each of the tidal cycles.

4. The system of claim 1, wherein the number of total cycles is fixed.

5. The system of claim 1, wherein the number of total cycles is determined using a total therapy volume of a treatment and a fill volume per cycle.

6. The system of claim 1, wherein a full drain is completed after completing the number of tidal cycles.

7. The system of claim 1, wherein the plurality of inputs defining the peritoneal dialysis therapy for the patient comprise a night fill volume, a total therapy volume, an estimated ultrafiltration, and a maximum volume per cycle.

8. The system of claim 1, wherein during a drain part of each of the tidal cycles, the maximum reserve volume is retained in a cavity of the patient.

9. The system of claim 1, wherein the controller is configured to retain a number of cycles, a night fill volume, and a dwell time as fixed parameters.

10. A non-transitory computer readable storage medium storing instructions for a controller that, when executed, cause the controller to perform a method, the method comprising: receiving, by a controller of a peritoneal dialysis system, a plurality of inputs defining a peritoneal dialysis therapy for a patient; wherein the controller is adapted to customize the peritoneal dialysis therapy for the patient; calculating, by the controller, a number of total cycles for the peritoneal dialysis therapy for the patient, wherein the number of total cycles is an integer N; wherein a number of tidal cycles within the number of total cycles is N-l; calculating, by the controller, an amount of ultrafiltration per cycle for the peritoneal dialysis therapy for the patient; calculating, by the controller, a maximum reserve volume for the peritoneal dialysis therapy for the patient, wherein the maximum reserve volume is an amount of fluid reserved in each of the tidal cycles; and controlling, by the controller, the peritoneal dialysis therapy for the patient to retain the maximum reserve volume for each of the tidal cycles.

11. The non-transitory computer readable storage medium of claim 10, wherein calculating, by the controller, the maximum reserve volume includes using a maximum volume per cycle, a night fill volume, and an amount of ultrafiltration per cycle.

12. A system comprising: a dialysis fluid pump; an input interface device configured to receive a plurality of inputs defining a peritoneal dialysis therapy for a patient; and a controller configured to adapt the peritoneal dialysis therapy for the patient, wherein the controller is configured to: determine a number of total cycles for the peritoneal dialysis therapy for the patient, wherein the number of total cycles is an integer N; wherein a number of tidal cycles within the number of total cycles is N-l; determine an amount of ultrafiltration per cycle for the peritoneal dialysis therapy for the patient; determine a maximum reserve volume for the peritoneal dialysis therapy for the patient, wherein the maximum reserve volume is an amount of fluid reserved in each of the tidal cycles; and control the peritoneal dialysis therapy for the patient to retain a target reserve volume for each of the tidal cycles.

13. The system of claim 12, wherein the maximum reserve volume is determined using a maximum volume per cycle, a night fill volume, and an amount of ultrafiltration per cycle.

14. The system of claim 13, wherein the target reserve volume is input by an operator.

15. The system of claim 14, wherein in response to determining the target reserve volume is greater than the maximum reserve volume, the controller is configured to control the peritoneal dialysis therapy for the patient to retain the maximum reserve volume for each of the cycles.

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