WO2021226317A1

WO2021226317A1 - Automated infant peritoneal dialysis

Info

Publication number: WO2021226317A1
Application number: PCT/US2021/031046
Authority: WO
Inventors: Dean Jaris T. VILLANUEVA; Olivia M. MOSS; Marissa L. HEINTSCHEL; Stacy A. NUNEZ; Ashwin MUKUND; Catherine Joseph
Original assignee: Baylor College Of Medicine
Priority date: 2020-05-06
Filing date: 2021-05-06
Publication date: 2021-11-11

Abstract

Infants born prematurely or with defects may require kidney support, and due to their size, peritoneal dialysis is the primary solution to supplement the kidneys' function. Currently, there is only a manual option to support these neonates, especially those under 12 kg;therefore, a new generation peritoneal dialysis device automating the fluid exchange process with precision and reliability are desired goals. An improved peritoneal dialysis system and method are discussed herein that may include a display, heating mechanism, pump(s), microcontroller(s), valve(s), actuators(s), and sensor(s) in order to partially or fully automate the system, as well as to provide monitoring.

Description

TITLE: AUTOMATED INFANT PERITONEAL DIALYSIS

RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63/020,848 filed on May 6, 2020, which is incorporated herein by reference.

FIELD OF THE INVENTION

[0002] This invention generally relates to automated peritoneal dialysis, and more particularly such dialysis for infants.

BACKGROUND OF INVENTION

[0003] Peritoneal dialysis (PD) is a mode of dialysis or renal replacement therapy which can be used to removal fluid and waste products from those with severe renal injury. It takes over the functions of the kidney when the kidney is too ill to able to function. It is an important method of providing dialysis in infants. Peritoneal dialysis involves supplying dialysis fluid or dialysate to the peritoneum or infusion. The dialysate may often be heated to body temperature prior to infusion. The dialysate is allowed to dwell in peritoneum or diffusion stage for a desired amount of time, thereby allowing patient absorption of nutrients, medication, or the like and/or filtering of waste, toxins, or the like from the patient. Once dwell time is complete, the fluid is drained from the peritoneum. The process may be repeated as desired in accordance with a treatment plan. E.g. see https://www.openpediatrics.org assets/simulator/peritoneaI-diaiysis-simulator or https://en.wikipedia.org/wikl/Peritoneaj dialysis to view a demonstration of the technique. Infants have kidney injury from various causes including congenital malformations and genetic diseases. Premature infants are even more at risk for developing kidney injury than their full term counterparts. [0004] The technical requirements of infant peritoneal dialysis include a flexible catheter small enough to be placed in an infant’s abdomen, which contains the peritoneal space, and dialysis fluid to infuse small volumes for exchanges, such as overnight. Automated PD cyclers have made this process very feasible for children. However, manual peritoneal dialysis is a renal replacement therapy is necessary for infants who have kidney injury and who are too small to use an automated cycler. Typically, it use is when children need to start dialysis right after the catheter is placed.

[0005] The manual PD is a set up composed of dialysis fluid bags connected to a measuring burette which then drains into a systems of tubing connected by stop-cock valves to the dialysis catheter that resides in the infant’s abdomen. See Fig. 9 for the set up used. This is labor intensive and relies on manual fill and drain cycles that occur every hour to perform dialysis, as well as shifting and/or tilting the patient to aid waste removal. Typically, a medical professional will have to manually turn valves on and off up to 4 times/hour for the dialysis cycle. Additionally, the medical professional may have several infants on the same floor requiring such treatment.

[0006] The goal is to simplify manual peritoneal dialysis for neonates and infants. In place of a purely mechanical model that runs on gravity, the invention aims to mechanize/automate aspects of its functioning - either 1) to infuse or drain the dialysis fluid with a motorized system, 2) using sensors to detect and maintain pressure in the tubing to have adequate forward flow and 3) having alarm systems in place that detect kinks, and/or 4) having a display that demonstrate drain volumes or alarms. These steps would conserve time for the medical professional and allow for smoother cycles of dialysis. SUMMARY OF INVENTION

[0007] In one embodiment, improved peritoneal dialysis is provided that allows for partial or full automation. Improved tubing is provided, which is fed into the system and is responsible for containing the dialysate and waste products. Embodiments of the invention may include peritoneal dialysate tubing as mentioned previously, as well as motors, microcontrollers, and sensors to automate the process. Some embodiments may include a heating box to heat the fluid which will enter into the infant undergoing treatment; and/or a peristaltic pump which will move dialysate fluid into the peritoneum and move waste products into the waste bag. Additional embodiments may include a stepper motor which will shift the system from supplying dialysate to removing waste. Before the connection to the neonate's peritoneum, a flow sensor to monitor fluid coming in and out may be provided in some embodiments, and can also be used to provide feedback data to the system. The software developed can track and/or control the cycles of insertion and removal, including temperature control, cycle tracking, and/or alarms.

[0008] This device can be used for kidney support for infants who have undergone trauma, such as infants under 12 kg. Peritoneal dialysis is a mode of dialysis (renal replacement therapy) used to remove fluid and waste products from temporarily hampered renal function. It takes over the function of the kidneys when the kidneys are too ill to function.

[0009] In another embodiment, a peritoneal dialysis (PD) system comprises a heating box coupled to a bag providing dialysate for a patient. The system may provide a pump coupled to the heating box for drawing dialysate from the bag and a three-port valve coupled to the pump for directing fluid flow. The three-port valve provides a first positon that allows the dialysate to be directed to a patient’s peritoneum and a second position fluidically coupling a catheter for the patient’s peritoneum to an overflow bag. An actuator coupled to the three-port valve selects positioning of the three-port valve to control flow as desired. A flow sensor coupled to the three- port valve measures flow between the three-port valve and a catheter to the patient’s peritoneum. An overflow bag coupled to the three-port valve to receive waste flow when desired. At least one controller operates the system, and the controller is coupled to the heating box, pump, actuator, and/or flow sensor. The system may also provide a display that allows information regarding the system to be viewed and/or the system to be controller for semi or fully automated dialysis as desired.

[0010] In yet another embodiment, a method for peritoneal dialysis is provided. The method may include coupling the heating box to a pump for drawing dialysate from a bag, and coupling the pump to a three-port valve for directing fluid flow, wherein the three-port valve provides a first positon that allows the dialysate to be directed to a patient’s peritoneum and a second position fluidically coupling a catheter for a patient’s peritoneum to an overflow bag. An actuator may be coupled to the three-port valve to select positioning of the three-port valve as desired. A flow sensor is coupled to the three-port valve to measure flow between the three-port valve and a catheter to the patient’s peritoneum, thereby allowing supplied dialysate or waste drained to be measured. Further, the three-port valve may be coupled to an overflow bag that receives waste flow when the three-port valve is in a proper position. At least one controller is provided for operating the PD system, and the controller is coupled to the heating box, pump, actuator, or flow sensor. A display may also be provided that allows information regarding the system to be viewed and/or the system to be controller for semi or fully automated dialysis as desired.

[0011] The foregoing has outlined rather broadly various features of the present disclosure in order that the detailed description that follows may be better understood. Additional features and advantages of the disclosure will be described hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS [0012] For a more complete understanding of the present disclosure, and the advantages thereof, reference is now made to the following descriptions to be taken in conjunction with the accompanying drawings describing specific embodiments of the disclosure, wherein:

[0013] FIG. 1 shows an embodiment of a peritoneal dialysis system and corresponding components;

[0014] FIGS. 2A-2D show an embodiment of a peristaltic pump cylinder, a peristaltic pump peg holder, peristatic pump view in operation, and peristatic pump logic table;

[0015] FIGS. 3A-3B show an embodiment of a heating box top and bottom;

[0016] FIG. 4 shows an embodiment of a heating box schematic;

[0017] FIGS. 5A-5B shows an embodiment of a stepper motor adaptor and three-way valve; [0018] FIG. 6 shows an embodiment of a flow sensor;

[0019] FIG. 7 shows an embodiment of a schematic for the system;

[0020] FIGS. 8A-8E shows an embodiment of a display block diagram, main display, display providing dialysis information, dialysis setting display, and data log display; and [0021] FIG. 9 shows a manual PD setup.

DETAILED DESCRIPTION

[0022] Refer now to the drawings wherein depicted elements are not necessarily shown to scale and wherein like or similar elements are designated by the same reference numeral through the several views.

[0023] Referring to the drawings in general, it will be understood that the illustrations are for the purpose of describing particular implementations of the disclosure and are not intended to be limiting thereto. While most of the terms used herein will be recognizable to those of ordinary skill in the art, it should be understood that when not explicitly defined, terms should be interpreted as adopting a meaning presently accepted by those of ordinary skill in the art.

[0024] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only, and are not restrictive of the invention, as claimed. In this application, the use of the singular includes the plural, the word “a” or “an” means “at least one”, and the use of “or” means “and/or”, unless specifically stated otherwise. Furthermore, the use of the term “including”, as well as other forms, such as “includes” and “included”, is not limiting. Also, terms such as “element” or “component” encompass both elements or components comprising one unit and elements or components that comprise more than one unit unless specifically stated otherwise.

[0025] Improved systems and method for peritoneal dialysis (PD) are discussed herein. Peritoneal dialysis is form of dialysis that is performed within the body using the peritoneum and dialysate. Because an infant’s body cannot typically handle the rapid change of blood loss in order to prime hemodialysis, peritoneal dialysis is advantageous over other forms of dialysis, such as for infants under 12 kg. While particularly applicable to infants in such situations, one of ordinary skill of the art will recognize the systems and methods discussed herein are not limited to infant treatment. In some embodiments, the improved systems and methods is utilized for neonates and infants including in some embodiments infants under 12 kg, whereas other embodiments may involve treatment of non-infants. Embodiments of the systems and methods may comprise a heating box(s), pump(s), valve(s), actuator(s), sensor(s), display(s), or combinations thereof. In some embodiments, controller(s), processor(s), or the like may be provided to control various aspects of the system or method. The term controller/microcontroller as utilized herein may encompass one or more controller(s), microcontroller(s), processor(s), microprocessor(s), or the like.

[0026] Further discussion of exemplary systems and methods are provided herein. It shall be understood that the following discussion are merely nonlimiting examples or examples corresponding to experimental setup(s), and other embodiments may vary from such examples. The system or device can be considered as parts or subassemblies. Each of these is describe herein with more detail.

[0027] As discussed previously above, PD may involve supplying dialysate to the peritoneum or infusion; allowing dialysate to dwell in peritoneum or diffusion stage for a desired amount of time, and draining of the fluid from the peritoneum. The process may be repeated as desired in accordance with a treatment plan. PD can be quite labor intensive, as it may be necessary to perform manual fill/measurement and drain cycles as frequently as every hour and may also require shifting and/or tilting the patient to aid waste removal in some cases. Further, medical professional may have several infants on the same floor requiring such treatment, and current manual setups may require the professional turn valves on and off up to 4 times/hour for the dialysis cycle. Not only are other forms of dialysis inappropriate for infants, but current automated cycler are also not suitable for small infants, such as those under 12 kg.

[0028] A non-limiting of a PD system are discussed herein resolving above noted concerns. FIG. 1 shows an example of a PD system may comprising a heating box 10, pump 20, valve 30, actuator 40, flow sensor 50, and waste bag 60. The heating box 10 is coupled to a dialysate supply, such as a bag supplying dialysate, and the heating box heats the dialysate to a desired temperature. The pump 20 is coupled to the heating box 10 and provides pumping action to the system when the pump is operated. Pump(s) that do not contact the dialysate are preferable to avoid contaminate concerns, such as a peristaltic pump. The valve 30 is coupled to the pump 20, such as to a first port of the valve, and directs fluid flow through the systems as desired, such as by controlling the fluidic connection between ports of the valves. As a nonlimiting example, valve 30 may be a three -port valve or stopcock providing fluidic connection between a pump port and a peritoneal port or essentially a first position that allows the dialysate to be directed to a patient’s peritoneum. Valve 30 may also allow the peritoneal port and a waste port to be fluidically connected or essentially a second position coupling the catheter in the patient’s peritoneum to a waste bag 60, thereby allowing waste fluid to be drained. Additionally, valve 30 may also provide a closed position that prevents flow through the valve or fluidically disconnects the ports of the valve from each other. An actuator 40 may be coupled to the valve 30 to control, operate, or switch the valve between the fluidic connections as desired. A nonlimiting example of a suitable actuator 40 may be a stepper motor. A second port of the valve is coupled to a flow sensor 50 that measures fluid flow. The opposing end of the flow sensor 50 is coupled to a catheter directed to the patient’s peritoneum. The last or 3^rd port of the valve 30 is coupled to a waste bag 60 that allows waste fluids to be drained when the valve is placed in a proper position, such as the second position fluidically linking the catheter in the peritoneum to the waste bag. Examples of the various components of the system discussed above are discussed in further detail below, which shall be understood to be nonlimiting examples.

[0029] An exemplary pump is illustrated in Figs. 2A-2C. The pump 20 may be peristaltic pump or a positive displacement pump used for pumping a variety of fluids, they are also referred to as roller pumps. The pump 20 is also coupled to a controller and/or motor driver that control operation of the motor. Unique 3D printed specific rollers that are fitted to the tubing of the pump were made to maximize efficient delivery without kinking. The hole 2 of a pump cylinder will fit in a space defined by the three cylinder rollers 3 of a pump peg holder. The outer diameter 1 the pump cylinder will touch or nearly touch the cylinder rollers 3. As the pump peg holder (Fig. 2B) rotates within the pump cylinder (Fig. 2A), the compression of the tubing causes fluid flow (Fig. 2C). The motor hole 4 of the pump peg holder is coupled to a motor of the peristaltic pump that rotates pump peg holder and the three cylinder rollers. The outer diameter 5 is the area of which will be placed inside the peristaltic pump.

[0030] In a nonlimiting example corresponding to an experimental setup, the peristaltic pump is coupled to a main microcontroller (e.g. Raspberry Pi). The pump is controlled by a motor driver, which relays logic signals sent by the microcontroller. A logic table is shown in Fig. 2D that illustrates how software provided may operate. The microcontroller outputs these HIGHs and LOWs to the motor driver, which tells the pump what mode it should be in. This allows automation of the dialysis process through its three phases: Infusion, Dwelling, and Draining. [0031] An exemplary heating box is illustrated in Figs. 3A-3B. The heating box with entrance receiving dialysate from a supply and exit to the remainder of the system tubing is used to heat the fluid that will be pumped into the patient. The heating box may provide a bottom and top portions, optionally hinged (Figs. 3A & 3B respectively). The heating box may be formed of any suitable materials, such as polylactic acid. The box may be optionally lined with any desirable materials (e.g. polyurethane, Mylar). For example, some embodiments may desirably include flame retardant material(s) (e.g. polyurethane), water resistant material(s) (e.g. polyurethane), and/or heat insulation material(s) (e.g. Mylar). The two semicircles 6 and 7 are cut notches to provide the entrance and exit for the tubing (e.g. Utah Medical Tubing) within the heating system. In some embodiments, the heating box may provide a lock. Further, one or more heating elements for heating dialysate to a desired temperature and a temperature probe/sensor for monitoring temperature, both coupled to a controller, may also be provided by the heating box (not shown).

[0032] In a nonlimiting embodiment of the heating box corresponding to an experimental setup, resistive pads may be utilized as the heating element. The heating box receives dialysate from a supply source via tubing. Lengthy tubing routing through the heating box allows the fluid to be heated in the heating box. On heated, the fluid may exit the heating box via exit tubing. A nonlimiting embodiment of a heating system diagram is shown in Fig. 4. Dialysate is heated, such as by using two resistive pads (Rl, R2) of 6.227 and 6.120 ohms respectively, which are connected in parallel. The resistive pads may be coupled to and/or fed power (e.g. 5V) via a microcontroller or the like (e.g. Raspberry Pi). The resistive pads are heated to 40°C, which is adequate enough to heat the dialysate. The system is monitored by a temperature probe (TP) detecting temperature and providing temperature data to the microcontroller. Some embodiments may relay the temperature of the dialysate to a display.

[0033] An exemplary valve and actuator, such as a three-port valve and stepper motor are illustrated in Figs. 5A-5B. A stepper motor 40 is used to actuate or rotate the three-port or relief valve as desired to move the valve between different positions. For example, the motor may rotate the valve ninety degrees to the left or right as desired, such as to allow continuous flow of the dialysis solution. As shown in Fig. 5A, an adapter allows the motor 40 to be coupled the valve 30 and operate the valve as desired. The adapter provides two cylinders stacked on one another 14 and 15. The hole at the top 8 has two layers of dimensions that allow the motor 40 to be coupled to the adapter. For example, the first dimension may be a circular circumference 9, and the second dimension changing a quarter of the way down is a rectangular structure 16. This will allow the stepper motor to fit securely and operate the valve 30. The length of the stepper motor rotor correspond to the depth 11 shown, and does not extend all the way to the next cylinder base 15. The bottom cylinder base 15 will form to the T-connector dimensions 13 suitable for coupling to the valve 30. As a nonlimiting example, hole 12 suitable for receiving and operating the valve actuator is provided by the adapter, such as a rectangular hole fitting on a rectangular valve switches the valve between different positions controlling flow. As shown in the nonlimiting example corresponding to an experimental setup of Fig. 5B, the motor operates the valve as desired by rotating 90°. The valve may control the pathway for dialysate to the peritoneum by rotating as desired, i.e. a first position (shown) fluidically linking dialysate and peritoneum pathways allowing dialysate to be pumped to the peritoneum. The valve may also be rotated to a second position (e.g. rotated 90° clockwise) linking the peritoneum to the waste bag to allow gravity draining of the waste fluids, such as after 45-60 minutes or the like. Additionally, other embodiments of the systems and methods may be setup to allow for negative pressure draining of waste fluids, if desired.

[0034] An exemplary flow sensor is illustrated in Fig. 6. The flow sensor 50 (placed between valve 30 and a patient as shown in Fig. 1) is able to correctly determine the amount of fluid going into or out of the patient, or essentially measure flow between the valve 30 and catheter to the patient’s peritoneum. The sensor 50 may be coupled the valve and patient utilizing any suitable means. The sensor 50 may provide a turbine wheel with a magnet provided for one of the wheels. As fluid flow causes the turbine to rotate, the wheel providing the magnet may pass a sensor detecting the magnet or a complete rotation of the wheel, thereby allowing the flow rate to be determined. The sensor 50 allows detection of any kinks in tubing to be observed by data indicating flow has stopped or reduced significantly, and an alarm to be triggered accordingly. [0035] In a nonlimiting example representative of an experimental setup, various items are utilized to facilitate connection (e.g. catheter connectors or Leur locks) between the valve and patient. Connector 610 allows the valve to be connected with the sensor 50 via tubing 620 and connector 630. The opposing end of the sensor 50 provides a connector 640 coupled to tubing 650 with an opposing end 660 leading to the patient’s catheter.

[0036] An exemplary schematic of the system is illustrated in Figure 7. One or more controller(s) or microcontroller(s) 710 (e.g. Raspberry Pi) can be used to control components of the system: including but not limited to the display 720, power supply 730, peristaltic pump 740 (e.g. via motor driver), flow sensor 750, heating box (not shown), and/or stepper motor 760. A display 720 is coupled to the microcontroller 710, such as via USB input and/or HDMI, to a graphical user interface (GUI) to control and/or monitor the dialysis process. In some embodiments, input devices, such as keyboard, mouse, etc., may be provided, and in other embodiments the display may provide touchscreen capabilities. Each component of the system is coupled to the microcontroller 710 allowing data communication, commands and/or power to be delivered via an input/output stream with the microcontroller. The microcontroller 710 may also provide storage (internal or external) for firmware, software, or other code utilized to control components of the system as desired.

[0037] The controller 710 allow for automated control of the PD system between infusion, dwell, and drainage cycles. During the infusion cycle, the controller 710 operates the pump and actuates the three -port valve to the first position, thereby allowing dialysate to be pumped to the peritoneum. During the dwell cycle, the controller stops the pump and may operate the three- port valve to a closed position. During the drainage cycle, the controller may operates the three- port valve to the second position to allow drainage from the peritoneum to the waste bag. The display 720 provides a variety of information on the system, such as but not limited to infusion time, dwell time, and draining time. The display may also provide information on infusion volume, drain volume, and flow rate. The system or display allows a user to set desired setting for dialysis, such as but not limited to flow rate, heating temperature, infusion volume, drain volume, or a number of cycles to be performed.

[0038] In a nonlimiting example representative of an experimental setup, a first Raspberry Pi (Fig. 7) was coupled to the peristaltic pump, flow sensor and stepper motor for reasons relating to the experimental setup - however, a single microcontroller or more than two may be utilized in other embodiments as discussed above. Additionally, the motor driver is used to control the peristaltic pump. The motor driver is wired to a 3V logic pin and four other control pins from the microcontroller to control the speed and direction of the peristaltic pump. A 12V power supply is wired to the motor driver to supply the pumps with the voltage required to power them and a common ground is established with the microcontroller and motor driver to close the circuit. The flow sensor is wired to a separate 3V logic pin, ground pin and data pin from the motor driver. The stepper motor is wired to a 5V logic pin, ground pin and four data pins separate from the other two components. Each data pin will be used to tell the degrees of rotation that the stepper gear rotates to.

[0039] Due to the nonlimiting experimental heating system being located away from our other electrical systems, a separate microcontroller (e.g. Raspberry Pi) for controlling and recording temperature (Fig. 4). The heating systems works with two resistive heating pads that are connected in parallel, which are supplied with 5 volts from the Raspberry Pi. With 5 volts supplied, the internal resistances heat to about 40°C, which is enough to heat our dialysate to body temperature. A temperature probe is also connected in parallel, which feeds directly to the display. [0040] Figs. 8A-8E show exemplary designs for the LCD Screen Graphical User Interface (GUI). A general layout of the GUI in a block diagram and the actual GUI display 830 running are shown. In a nonlimiting example, the design involves two parts: log-in 810 and main display. After a medical professional logs in 810, a patient remain anonymous by inputting a "patient ID" 820 rather than name. The main display is coupled to various components 840 of the system via the microcontroller, thereby allow a variety of data to be gathered/shown and the system to be controlled via the GUI if desired. The main display may allow a variety of information to be viewed (Fig. 8C), such as dialysis parameters 870, treatment progress 860, general information (e.g. patient ID, system status, etc.), timers (e.g. infuse timer, drain timer, dwell timer, time elapsed, start time, etc.), dialysis volume information (e.g. infusion volume, drain volume, flow rate, etc.) and/or the like. The main display may also allow control over the system, such as via progress or control menu (e.g. run, stop, gravity mode, edit dialysis, test alarm). The design allows for customized treatments, such entry of dialysis parameters, such as patient weight, volume to infuse, volume to drain, number of cycles, flow rate, etc. (e.g. Fig. 8D). The main display may also allow data logging 850 to be viewed as desired (Fig. 8E, start time, end time, flow rate, vol. in, vol. out, etc. for different cycles). HIPAA compliance should be considered so patient confidentiality was also integrated. Only an anonymous patient ID is utilized, and the patient weight input for the treatment will only appear in the exported data log file. Additionally, the user has the option to deviate from the normal treatment, by editing the dialysis parameters 870. All of this information is stored in accordance with the software, and any important data, such as volumes infused or drained are displayed on the data log. Additionally, an alarm system allows the user to hear if the treatment has been completed 860 or if any errors has occurred, such as kinking of tubing. For example, an alarm to sound at the end of a treatment, completion of an infusion, dwell, or drain cycle, or completion of a full cycle (i.e. three aforementioned cycles) may be provided or another alarm to indicating kinking in tubing is detected.

[0041] The process for peritoneal dialysis is similar to the manual process discussed previously and incorporated by reference herein for brevity. Further, various actions of the process shall be apparent from the discussion of the system above and incorporated by reference herein. The process of preparation may involve coupling the heating box to a pump for drawing dialysate from the bag; coupling the pump to a three -port valve for directing fluid flow, wherein the three- port valve provides a first positon that allows the dialysate to be directed to a patient’s peritoneum; coupling an actuator to the three-port valve, wherein the actuator selects positioning of the three-port valve; coupling the three-port valve to a flow sensor, wherein the flow sensor measures flow between the three-port valve and a catheter to the patient’s peritoneum; and/or coupled the three -port valve to an overflow bag, wherein the overflow bag receives waste flow when the three -port valve is in a second position fluidically coupling the catheter in the patient’s peritoneum to the overflow bag. At least one controller is provided for operating the PD system, wherein the controller is coupled to the heating box, pump, actuator, or flow sensor. In preparation for performing dialysis, a bag providing dialysate may be coupled to a heating box for a patient, and a catheter may be provided to the patient’s peritoneum, such as to an infant under 12 kg. The controller allows for automated control of the PD system between infusion, dwell, and drainage cycles. During the infusion cycle, the controller operates the pump and actuates the three -port valve to the first position. During the dwell cycle, the controller stops the pump and operates the three-port valve to a closed position. During the drainage cycle, the controller operates the three-port valve to the second position. As discussed regarding the system above, a medical professional operating the system may input desired settings, such as but not limited to login information, patient ID, patient weight, volume to infuse, volume to drain, number of cycles to be run, and/or follow rate. Once the operator has completed entry of desired settings, the dialysis cycles may be initiated by the system. Should any issues arise, such as kinking in tubing detected by the system, an alarm may be provided. Upon completion of cycle(s) and/or a full cycle, an alarm may be provided.

[0042] Experimental examples discuss herein are included to demonstrate particular aspects of the present disclosure. It should be appreciated by those of ordinary skill in the art that the methods described in the examples that follow merely represent illustrative embodiments of the disclosure. Those of ordinary skill in the art should, in light of the present disclosure, appreciate that many changes can be made in the specific embodiments described and still obtain a like or similar result without departing from the spirit and scope of the present disclosure.

[0043] Embodiments described herein are included to demonstrate particular aspects of the present disclosure. It should be appreciated by those of skill in the art that the embodiments described herein merely represent exemplary embodiments of the disclosure. Those of ordinary skill in the art should, in light of the present disclosure, appreciate that many changes can be made in the specific embodiments described and still obtain a like or similar result without departing from the spirit and scope of the present disclosure. From the foregoing description, one of ordinary skill in the art can easily ascertain the essential characteristics of this disclosure, and without departing from the spirit and scope thereof, can make various changes and modifications to adapt the disclosure to various usages and conditions. The embodiments described hereinabove are meant to be illustrative only and should not be taken as limiting of the scope of the disclosure.

Claims

CLAIMS What is claimed is:

1. A peritoneal dialysis (PD) system comprising: a heating box coupled to a bag providing dialysate for a patient; a pump coupled to the heating box for drawing dialysate from the bag; a three-port valve coupled to the pump for directing fluid flow, wherein the three-port valve provides a first positon that allows the dialysate to be directed to a patient’s peritoneum; an actuator coupled to the three-port valve, wherein the actuator selects positioning of the three-port valve; a flow sensor coupled to the three-port valve, wherein the flow sensor measures flow between the three-port valve and a catheter to the patient’s peritoneum; an overflow bag coupled to the three-port valve, wherein the overflow bag receives waste flow when the three-port valve is in a second position fluidically coupling the catheter in the patient’s peritoneum to the overflow bag; and at least one controller operating the PD system, wherein the controller is coupled to the heating box, pump, actuator, or flow sensor.

2. The system of claim 1, wherein the heating box comprises one or more heating elements and a temperature probe.

3. The system of claim 2, wherein the heating box is a hinged box with notches for tubing, and the hinge box is lined with a non-flammable material and an insulation material.

4. The system of claim 1, wherein the pump is a peristaltic pump that does not contact pumping fluids.

5. The system of claim 1, wherein the actuator is a stepper motor coupled to the three-port valve by an adapter that allows the stepper motor to actuate the valve as desired to the first position and the second position.

6. The system of claim 1 further comprising a display that provides a graphical user interface (GUI) coupled to the controller.

7. The system of claim 6, wherein the display provides information on infusion time, dwell time, and draining time.

8. The system of claim 6, wherein the display provides information on infusion volume, drain volume, and flow rate.

9. The system of claim 6, wherein the system or the display allows a user to set flow rate, heating temperature, infusion volume, drain volume, or a number of cycles to be performed.

10. The system of claim 1, wherein an alarm is provided for completion of a cycle or detection of a kink in tubing.

11. The system of claim 1, wherein the controller automates control of the PD system between infusion, dwell, and drainage cycles.

12. The system of claim 11, wherein during the infusion cycle, the controller operates the pump and actuates the three-port valve to the first position.

13. The system of claim 11, wherein during the dwell cycle, the controller stops the pump and operates the three-port valve to a closed position.

14. The system of claim 11, wherein during the drainage cycle, the controller operates the three-port valve to the second position.

15. The system of claim 1, wherein the patient is an infant under 12 kg.

16. A method for peritoneal dialysis, the method comprising the steps of: coupling the heating box to a pump for drawing dialysate from a bag; coupling the pump to a three-port valve for directing fluid flow, wherein the three-port valve provides a first positon that allows the dialysate to be directed to a patient’s peritoneum; coupling an actuator to the three -port valve, wherein the actuator selects positioning of the three-port valve; coupling the three-port valve to a flow sensor, wherein the flow sensor measures flow between the three-port valve and a catheter to the patient’s peritoneum; and coupled the three-port valve to an overflow bag, wherein the overflow bag receives waste flow when the three-port valve is in a second position fluidically coupling the catheter in the patient’s peritoneum to the overflow bag, wherein further at least one controller is provided for operating the PD system, wherein the controller is coupled to the heating box, pump, actuator, or flow sensor.

17. The method of claim 16 further comprising the step of coupling the bag providing dialysate to a heating box for a patient, wherein further the controller automates control of the PD system between infusion, dwell, and drainage cycles.

18. The method of claim 17, wherein during the infusion cycle, the controller operates the pump and actuates the three-port valve to the first position.

19. The method of claim 17, wherein during the dwell cycle, the controller stops the pump and operates the three-port valve to a closed position.

20. The method of claim 17, wherein during the drainage cycle, the controller operates the three-port valve to the second position.