Closed-loop peritoneal dialysis system

Abstract

The system comprises a housing, water supply paths, dialysate supply paths, discharge paths, and a patient path, each extending from the housing. The system also comprises a first port, a second port, a third port, and a fourth port, all accessible from the outside of the housing. The first port can be connected to the water supply path, the second port to the dialysate supply path, the third port to the discharge path, and the fourth port to the patient path. The system also comprises a first cleaning path, a second cleaning path, and a third cleaning path, each contained within the housing. The first cleaning path terminates at the first and third ports, the second cleaning path terminates at the second port, and the third cleaning path terminates at the fourth port and the discharge path within the housing.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 490,676, filed on March 16, 2023, the entire content of which is incorporated herein by reference.

Background Art

[0002] There are two main dialysis methods used to assist patients who need renal replacement therapy, namely hemodialysis and peritoneal dialysis. Peritoneal dialysis utilizes the patient's own peritoneum as a semi - permeable membrane. The peritoneum is the membranous lining of the body cavity that surrounds all organs between the diaphragm and the pelvis and has numerous blood vessels and capillaries embedded in it, so it can act as a natural semi - permeable membrane.

[0003] In peritoneal dialysis, a sterile dialysis solution is infused into the peritoneal cavity using an indwelling catheter. This can be accomplished manually by gravity or by using a machine known as a cycler. An osmotic pressure gradient is created by including an osmotic substance in the peritoneal dialysis solution. The osmotic substance used in most peritoneal dialysis solutions is glucose. The dialysis solution is retained in the peritoneal cavity for a sufficient length of time (e.g., 4 hours) to produce a net removal of toxins and water, after which the dialysis solution is drained and replaced with fresh dialysis solution.

[0004] There are two main forms of peritoneal dialysis (PD): continuous self-controlled peritoneal dialysis (CAPD) and continuous periodic peritoneal dialysis (CCPD). In CCPD, fluid exchange can be performed while the patient is asleep by the inflow and outflow of dialysate controlled by a cycla. This is designed to relieve the patient of the arduous task of performing these exchanges while they are awake. Typically, the cycla leaves the last fill volume in the patient just before they wake up, and this fill volume remains in the peritoneum until daytime when the patient performs the drainage. Thus, the patient has the option of leaving their peritoneum "dry" until that night, which has the benefit of allowing their peritoneum to recover from the constant outflow of a low pH / high molar osmotic concentration solution, or they can infuse another fill volume for the rest of the day if they require the removal of more toxins and water.

[0005] One drawback of CCPD is the burden of storing, connecting, disconnecting, and arranging supplies used during the process, such as sterile solution bags, piping sets, and connectors, as well as auxiliary supplies required to perform sterile connection / disconnection. [Overview of the project] [Means for solving the problem]

[0006] A first example includes a system for peritoneal dialysis, comprising a housing, a water supply path, a dialysate supply path, a drain path, and a patient path, each extending from the housing, a first port, a second port, a third port, and a fourth port accessible from the outside of the housing, the first port configured to connect to the water supply path, the second port configured to connect to the dialysate supply path, the third port configured to connect to the drain path, and the fourth port configured to connect to the patient path, and a first wash path, a second wash path, and a third wash path, each contained within the housing, the first wash path terminating at the first and third ports, the second wash path terminating at the second port, and the third wash path terminating at the fourth port and the drain path within the housing, respectively.

[0007] A second example includes a method for operating the system of the first example, the method including the steps of: determining that (i) a water supply route is not connected to the first port; (ii) a dialysate supply route is not connected to the second port; (iii) a discharge route is not connected to the third port; and (iv) a patient route is connected to the fourth port; and in response to the determination, operating the system in priming mode.

[0008] A third example includes a method for operating the system of the first example, the method including the steps of: determining that (i) a water supply path is not connected to the first port; (ii) a dialysate supply path is not connected to the second port; (iii) a discharge path is not connected to the third port; and (iv) a patient path is not connected to the fourth port; and in response to the determination, operating the system in patient discharge mode.

[0009] A fourth example includes a method for operating the system of the first example, the method including the steps of: determining that (i) a water supply route is not connected to the first port; (ii) a dialysate supply route is not connected to the second port; (iii) a discharge route is not connected to the third port; and (iv) a patient route is not connected to the fourth port; and in response to the determination, operating the system in patient-filled mode.

[0010] A fifth example includes a method for operating the system of the first example, the method including the steps of: determining that (i) a water supply path is not connected to the first port; (ii) a dialysate supply path is connected to the second port; (iii) a discharge path is not connected to the third port; and (iv) a patient path is connected to the fourth port; and in response to the determination, operating the system in a cleaning mode.

[0011] A sixth example includes a method for operating the system of the first example, the method including the steps of: determining that (i) a water supply route is connected to a first port; (ii) a dialysate supply route is connected to a second port; (iii) a discharge route is connected to a third port; and (iv) a patient route is connected to a fourth port; and in response to the determination, operating the system in disinfection mode.

[0012] A seventh example includes a method for operating the system of the first example, the method comprising the steps of: determining that (i) a disposable priming path is connected to the first port; (ii) a dialysate supply path is connected to the second port; (iii) a discharge path is connected to the third port; and (iv) a patient path is connected to the fourth port; and in response to the determination, operating the system in air removal mode.

[0013] An eighth example includes a method for operating the system of the first example, the method comprising: operating the system in priming mode while the dialysate supply route is connected to the dialysate supply bag and the patient route is connected to the fourth port, thereby filling the system with dialysate; operating the system in patient discharge mode while the patient route is connected to the patient's peritoneum, thereby draining used dialysate from the patient's peritoneum through the discharge route; operating the system in patient filling mode while the patient route is connected to the patient's peritoneum and the dialysate supply route is connected to the dialysate supply bag, thereby filling the patient's peritoneum with dialysate; and operating the system in washing mode while the water supply route is connected to the water supply bag, the dialysate supply route is connected to the second port, and the patient route is connected to the fourth port, thereby The method includes the steps of: filling the system with water; operating the system in disinfection mode while a water supply path is connected to a first port, a dialysate supply path is connected to a second port, a discharge path is connected to a third port, and a patient path is connected to a fourth port, thereby circulating heated water through a first wash path, a second wash path, and a third wash path; and operating the system in air removal mode while a water supply path is connected to a first bag port of a water supply bag, a dialysate supply path is connected to a second port, a disposable priming path is connected to a first port and a second bag port of a water supply bag, a discharge path is connected to a third port, and a patient path is connected to a fourth port, thereby capturing air received from the disposable priming path in the water supply bag.

[0014] When the terms “substantially” or “approximately” are used herein, it means that the proposed characteristic, parameter, or value does not need to be exactly achieved, but that deviations or changes, including, for example, tolerances, measurement errors, limits of measurement accuracy, and other factors known to those skilled in the art, may occur to the extent that the effect intended to be provided by the characteristic becomes impossible. In some examples disclosed herein, “substantially” or “approximately” means within ±0% to 5% of the proposed value.

[0015] These embodiments, advantages, and alternatives, as well as other embodiments, advantages, and alternatives, will become apparent to those skilled in the art by reading the following detailed description and referring to the accompanying drawings where appropriate. Furthermore, it should be understood that this summary and the other descriptions and figures provided herein are intended to illustrate the invention using only examples, and that numerous modifications are possible. [Brief explanation of the drawing]

[0016] [Figure 1] This is a block diagram of a system including computing devices, as an example. [Figure 2] This is a schematic diagram of a system configured for operation in priming mode, as an example. [Figure 3] This is a schematic diagram illustrating a system configured for operation in either patient discharge mode or patient filling mode. [Figure 4] This is a schematic diagram of a system configured for operation in cleaning mode, as an example. [Figure 5] This is a schematic diagram of a system configured for operation in disinfection mode, as an example. [Figure 6] This is a schematic diagram of a system configured for operation in air removal mode, as an example. [Figure 7] This is a schematic diagram of a male connector as an example. [Figure 8] This is a schematic diagram of a male connector as an example. [Figure 9] These are schematic diagrams of male and female connectors as an example. [Figure 10] This is a schematic diagram of the system using an example. [Figure 11] This is a schematic diagram of the system using an example. [Figure 12] This is a schematic diagram of a hook as an example. [Figure 13] This is a schematic diagram of the system using an example. [Figure 14] This is a block diagram of the method as illustrated by the example. [Figure 15] It is a block diagram of a method according to an example. [Figure 16] It is a block diagram of a method according to an example. [Figure 17] It is a block diagram of a method according to an example. [Figure 18] It is a block diagram of a method according to an example. [Figure 19] It is a block diagram of a method according to an example. [Figure 20] It is a block diagram of a method according to an example. [Figure 21] It is a block diagram of a method according to an example. [Figure 22] It is a schematic diagram of a system according to an example. [Figure 23] It is a schematic diagram of a system according to an example. [Figure 24] It is a schematic diagram of a system according to an example. [Figure 25] It is a schematic diagram of a system according to an example. [Figure 26] It is a schematic diagram of a system according to an example. [Figure 27] It is a schematic diagram of a system according to an example. [Figure 28] It is a schematic diagram of a system according to an example. [Figure 29] It is a schematic diagram of a system according to an example. [Figure 30] It is a schematic diagram of a system according to an example. [Figure 31] It is a schematic diagram of a system according to an example. [Figure 32] It is a schematic diagram of a system according to an example.

Embodiments for Carrying Out the Invention

[0017] This disclosure includes examples that can help alleviate some of the inconveniences of prior systems and methods used for peritoneal dialysis. Conventional methods and systems for peritoneal dialysis require the use and disposal of several disposable piping routes for each dialysis cycle. Storing, connecting, disconnecting, and disposing of such piping routes can be time-consuming and costly. Therefore, patients, suppliers, and payers would benefit from systems that require the use of as few disposable piping routes as possible. The systems described herein eliminate the use of all disposable piping sets, with the sole exception being the rare use of a single disposable piping route in the initial use for air removal. The systems can be configured to be closed-loop so that all internal components can be heated and disinfected between cycles.

[0018] Figure 1 is a block diagram of a system 200 for peritoneal dialysis. The system 200 includes a computing device 100A. In some examples, computing device 100A directly controls the system 200, while in other examples, computing device 100B can control the system 200 by sending commands to computing device 100A via wired or wireless communication. For example, computing device 100B can take the form of a tablet computer, laptop computer, smartphone, etc. The features and components of computing device 100 described below can be referenced to computing device 100A and / or computing device 100B in various examples. Further features of the system 200 are illustrated in detail in the following figures.

[0019] The computing device 100 comprises one or more processing units 102, a non-temporary computer-readable medium 104, a communication interface 106, and a user interface 108. The components of the computing device 100 are connected together by a system bus, network, or other connection mechanism 112.

[0020] One or more processing units 102 may be any type of processing unit connected to a non-temporary computer-readable medium 104, such as a microprocessor, a field-programmable gate array, a digital signal processor, or a multi-core processor.

[0021] The non-temporary computer-readable medium 104 may be any type of memory, such as volatile memory like random access memory (RAM), dynamic random access memory (DRAM), or static random access memory (SRAM), or non-volatile memory like read-only memory (ROM), flash memory, magnetic disk, optical disk, or compact disc read-only memory (CD-ROM), among the many devices used to store data or programs on a maintenance or permanent basis.

[0022] Furthermore, the non-temporary computer-readable medium 104 can store instructions 111. Instructions 111 can be executed by one or more processing units 102 to cause the computing device 100 to perform any of the functions or methods described herein.

[0023] The communication interface 106 may include hardware to enable communication within the computing device 100 and / or between the computing device 100 and one or more other devices. The hardware may include, for example, any type of input and / or output interface, a Universal Serial Bus (USB), PCI Express, a transmitter, a receiver, and an antenna. The communication interface 106 may be configured to facilitate communication with one or more other devices according to one or more wired or wireless communication protocols. For example, the communication interface 106 may be configured to facilitate wireless data communication for the computing device 100 according to one or more wireless communication standards, such as the Institute of Electrical and Electronics Engineers (IEEE) 801.11 standard, the ZigBee standard, or the Bluetooth standard. As another example, the communication interface 106 may be configured to facilitate wired data communication with one or more other devices. The communication interface 106 may also include an analog-to-digital converter (ADC) or a digital-to-analog converter (DAC) that the computing device 100 can use to control various components of the computing device 100 or external devices.

[0024] The user interface 108 may include any type of display component configured to display data. For example, the user interface 108 may include a touchscreen display device. Another example is that the user interface 108 may include a flat-panel display device, such as a liquid crystal display (LCD) or a light-emitting diode (LED) display device. The user interface 108 may include one or more hardware components used to provide data signals and control signals to the computing device 100. For example, the user interface 108 may include a mouse or pointing device, a keyboard or keypad, a microphone, a touchpad, or a touchscreen, among many possible types of user input devices. Generally, the user interface 108 allows the operator to interact with a graphical user interface (GUI) provided by the computing device 100 (for example, displayed by the user interface 108).

[0025] Figure 2 is a schematic diagram of system 200 configured for operation in priming mode. System 200 comprises a housing 202 and water supply paths 204A, dialysate supply paths 204B, dialysate supply paths 204C, dialysate supply paths 204D, dialysate supply paths 204E, discharge path 204F, and patient path 204G, each extending from the housing 202. System 200 also includes ports 206A, 206B, 206C, 206D, 206E, and 206F, which are accessible from outside the housing 202. System 200 also includes cleaning paths 208A, 208B, 208C, and 208D, each contained within the housing 202.

[0026] The cleaning path 208A terminates at ports 206A and 206B, the cleaning path 208B terminates at ports 206C and 206D, the cleaning path 208C terminates at ports 206E and 206F, and the cleaning path 208D terminates at port 206G and the discharge path 204F inside the housing 202. The valve 212K is operable to open and close the connection between the cleaning path 208D and the discharge path 204F.

[0027] System 200 also includes a water supply bag 223A, a dialysate supply bag 223B, a dialysate supply bag 223C, a dialysate supply bag 223D, and a dialysate supply bag 223E.

[0028] System 200 also includes a bypass path 221, a turbidity sensor 214, a heater 218, a temperature sensor 220A, a temperature sensor 220B, a conductivity sensor 291, a pump 216, and valves 212A, 212B, 212C, 212D, 212E, 212F, 212G, 212H, 212I, 212J, 212K, 212L, 212Y, and 212Z.

[0029] The enclosure 202 is typically a metal enclosure suitable for withstanding high temperatures and protecting the components inside the enclosure 202.

[0030] Route 204 consists of generally medical-grade piping made of ethylene propylene dienterpolymer (EPDM), silicone rubber, polypropylene, polyvinyl chloride (PVC), or polyethylene.

[0031] Port 206 can take the form of a female connector, which will be described in more detail later.

[0032] The cleaning pathway 208 consists of generally medical-grade piping made of ethylene propylene dienterpolymer (EPDM), silicone rubber, polypropylene, polyvinyl chloride (PVC), polyvinylidene fluoride (PVDF), fluorinated ethylene propylene (FEP), or polyethylene.

[0033] The valve 212 is configured to accept two pipe connections and to properly direct the fluid flow.

[0034] The turbidity sensor 214 is configured to generate an output representing the turbidity of the fluid entering and leaving the patient's body and to provide this output to the computing device 100.

[0035] The pump 216 is configured to push the fluid in both directions according to the input provided by the computing device 100.

[0036] The conductivity sensor 291 is configured to generate an output representing the conductivity of the fluid entering and leaving the heater 218, and to provide this output to the computing device 100.

[0037] Temperature sensors 220A and 220B are configured to generate an output representing the temperature of the fluid at the opposite end of the heater 218 and to provide that output to the computing device 100.

[0038] Bag 223 is a plastic medical supply bag configured to contain liquid medical supplies.

[0039] In the various modes of operation described herein, port 206A is configured to connect to dialysate supply path 204B, port 206B is configured to connect to dialysate supply path 204C, port 206C is configured to connect to water supply path 204A, port 206D is configured to connect to discharge path 204F, port 206E is configured to connect to dialysate supply path 204D, port 206F is configured to connect to dialysate supply path 204E, and port 206G is configured to connect to patient path 204G.

[0040] As described above, Figure 2 shows the system 200 configured for operation in priming mode.

[0041] In the first stage of priming mode, the valve 212 is configured as follows:

[0042] [Table 1]

[0043] In the first stage of priming mode, dialysate supply path 204B is connected to dialysate supply bag 223B, dialysate supply path 204C is connected to dialysate supply bag 223C, dialysate supply path 204D is connected to dialysate supply bag 223D, dialysate supply path 204E is connected to dialysate supply bag 223E, discharge path 204F is located in a sink, bathtub, or toilet, or is connected to a discharge bag, and patient path 204G is connected to port 206G. Pump 216 draws in the supply dialysate through dialysate supply path 204E, valve 212H, and pump 216, and pushes the supply dialysate through valve 212L, heater 218, patient path 204G, washing path 208D, valve 212K, and discharge path 204F. The glucose concentration of the dialysis fluid supplied in dialysis fluid supply bag 223E is generally higher than the glucose concentration of the dialysis fluid supplied in dialysis fluid supply bags 223B to 223D.

[0044] In the second stage of the priming mode, the valve 212 is configured as follows:

[0045] [Table 2]

[0046] In the second stage of priming mode, dialysate supply path 204B is connected to dialysate supply bag 223B, dialysate supply path 204C is connected to dialysate supply bag 223C, dialysate supply path 204D is connected to dialysate supply bag 223D, dialysate supply path 204E is connected to dialysate supply bag 223E, discharge path 204F is located in a sink, bathtub, or toilet, or is connected to a discharge bag, and patient path 204G is connected to port 206G. Pump 216 draws in the supply dialysate through dialysate supply paths 204B to 204D and pushes the supply dialysate through valve 212H, pump 216, valve 212L, heater 218, patient path 204G, washing path 208D, valve 212K, and discharge path 204F.

[0047] Figure 3 is a schematic diagram of the system 200 configured for operation in patient discharge mode. In patient discharge mode, the valve 212 is configured as follows:

[0048] [Table 3]

[0049] In patient discharge mode, patient pathway 204G is connected to the patient's peritoneum 219 via a catheter, and pump 216 draws in used dialysate through patient pathway 204G, heater 218, and valve 212L, and pushes the used dialysate through valve 212I and discharge pathway 204F.

[0050] Figure 3 is also a schematic diagram of the system 200 configured for operation in patient-filling mode. In patient-filling mode, the valve 212 is configured as follows:

[0051] [Table 4]

[0052] In patient filling mode, dialysate supply path 204B is connected to dialysate supply bag 223B, dialysate supply path 204C is connected to dialysate supply bag 223C, dialysate supply path 204D is connected to dialysate supply bag 223D, dialysate supply path 204E is connected to dialysate supply bag 223E, and patient path 204G is connected to the patient's peritoneum 219 via a catheter. Pump 216 draws in the dialysate through dialysate supply paths 204B-204D, pushes the dialysate through valve 212L, heater 218, and patient path 204G, and pushes it into the patient's peritoneum 219. During patient filling mode, heater 218 heats the dialysate to a temperature of approximately 98.6 degrees Fahrenheit.

[0053] In the final patient filling mode, the valve 212 is configured as follows:

[0054] [Table 5]

[0055] In the final patient filling mode, dialysate supply path 204B is connected to dialysate supply bag 223B, dialysate supply path 204C is connected to dialysate supply bag 223C, dialysate supply path 204D is connected to dialysate supply bag 223D, dialysate supply path 204E is connected to dialysate supply bag 223E, and patient path 204G is connected to the patient's peritoneum 219 via a catheter. Pump 216 draws in the supply dialysate through dialysate supply path 204E, pushes the supply dialysate through valve 212L, heater 218, and patient path 204G, and pushes it into the patient's peritoneum 219. During the final patient filling mode, heater 218 heats the supply dialysate to a temperature of approximately 98.6 degrees Fahrenheit.

[0056] Figure 4 is a schematic diagram of the system 200 configured for operation in cleaning mode. In the first stage of cleaning mode, the valve 212 is configured as follows:

[0057] [Table 6]

[0058] In the first stage of the washing mode, the water supply path 204A is connected to the water supply bag 223A, the dialysate supply path 204B is connected to port 206A, the dialysate supply path 204C is connected to port 206B, the dialysate supply path 204D is connected to port 206E, the dialysate supply path 204E is connected to port 206F, the discharge path 204F is located in the sink or connected to the discharge bag, and the patient path 204G is connected to port 206G. The pump 216 draws water through the water supply path 204A, valves 212Y, 212B, 212D, 212F, and 212H, and pushes the water through valve 212L, heater 218, patient path 204G, washing path 208D, valve 212K, and discharge path 204F.

[0059] In the second stage of the cleaning mode, the valve 212 is configured as follows:

[0060] [Table 7]

[0061] In the second stage of the washing mode, the water supply path 204A is connected to the water supply bag 223A, the dialysate supply path 204B is connected to port 206A, the dialysate supply path 204C is connected to port 206B, the dialysate supply path 204D is connected to port 206E, the dialysate supply path 204E is connected to port 206F, the discharge path 204F is located in the sink or connected to the discharge bag, and the patient path 204G is connected to port 206G. Pump 216 draws water through the water supply path 204A, valves 212Y and 212A, dialysate supply path 204B, washing path 208A, dialysate supply path 204C, valves 212C, 212D and 212E, dialysate supply path 204D, washing path 208C, dialysate supply path 204E, valves 212G and 212H, and pushes the water through valve 212L, heater 218, patient path 204G, washing path 208D, valve 212K, and discharge path 204F.

[0062] In the third stage of the cleaning mode, the valve 212 is configured as follows:

[0063] [Table 8]

[0064] In the third stage of the washing mode, the water supply path 204A is connected to the water supply bag 223A, the dialysate supply path 204B is connected to port 206A, the dialysate supply path 204C is connected to port 206B, the dialysate supply path 204D is connected to port 206E, the dialysate supply path 204E is connected to port 206F, the discharge path 204F is located in the sink or connected to the discharge bag, and the patient path 204G is connected to port 206G. The pump 216 draws water through the water supply path 204A, valve 212Z, bypass path 221, heater 218, and valve 212L, and pushes the water through valve 212I and the discharge path 204F.

[0065] Figure 5 is a schematic diagram of the system 200 configured for operation in disinfection mode. In the first stage of disinfection mode, valve 212 is configured as follows:

[0066] [Table 9]

[0067] In the first stage of the disinfection mode, the water supply route 204A is connected to port 206C, the dialysate supply route 204B is connected to port 206A, the dialysate supply route 204C is connected to port 206B, the dialysate supply route 204D is connected to port 206E, the dialysate supply route 204E is connected to port 206F, the discharge route 204F is connected to port 206D, and the patient route 204G is connected to port 206G.

[0068] In the first stage of the disinfection mode, pump 216 circulates water through water supply path 204A, valves 212Y, 212B, 212D, 212F, 212H, pump 216, valve 212L, heater 218, patient path 204G, washing path 208D, valve 212K, discharge path 204F, and washing path 208B, returning to water supply path 204A. Heater 218 heats the water to approximately 80°C.

[0069] In the second stage of the disinfection mode, the valve 212 is configured as follows:

[0070] [Table 10]

[0071] In the second stage of the disinfection mode, pump 216 circulates water back to water supply path 204A via water supply path 204A, valve 212Y, valve 212A, dialysate supply path 204B, wash path 208A, dialysate supply path 204C, valve 212C, valve 212D, valve 212E, dialysate supply path 204D, wash path 208C, dialysate supply path 204E, valve 212G, valve 212H, pump 216, valve 212L, heater 218, patient path 204G, wash path 208D, valve 212K, discharge path 204F, and wash path 208B. Heater 218 heats the water to approximately 80°C.

[0072] In the third stage of the disinfection mode, the valve 212 is configured as follows:

[0073] [Table 11]

[0074] In the third stage of the disinfection mode, pump 216 circulates water back to water supply path 204A via water supply path 204A, valve 212Z, bypass path 221, heater 218, valve 212L, pump 216, valve 212I, discharge path 204F, and washing path 208B. Heater 218 heats the water to approximately 80°C.

[0075] Figure 6 is a schematic diagram of system 200 configured for operation in air removal mode. System 200 includes a disposable priming path 204H used in air removal mode. In the first stage of air removal mode, valve 212 is configured as follows:

[0076] [Table 12]

[0077] In the first stage of the air removal mode, the water supply path 204A is connected to the first bag port of the water supply bag 223A, the dialysate supply path 204B is connected to port 206A, the dialysate supply path 204C is connected to port 206B, the dialysate supply path 204D is connected to port 206E, the dialysate supply path 204E is connected to port 206F, the disposable priming path 204H is connected to port 206C and the second bag port of the water supply bag 223A, the discharge path 204F is connected to port 206G, and the patient path 204G is connected to port 206D.

[0078] In the first stage of the air removal mode, the pump 216 circulates water through the water supply path 204A, valves 212Y, 212B, 212D, 212F, 212H, pump 216, valve 212L, heater 218, patient path 204G, washing path 208D, valve 212K, discharge path 204F, washing path 208B, and disposable priming path 204H, thereby capturing air received from the fluid path and disposable priming path 204H in the water supply bag 223A.

[0079] In the second stage of the air removal mode, the valve 212 is configured as follows:

[0080] [Table 13]

[0081] In the second stage of the air removal mode, the pump 216 circulates water through the water supply path 204A, valves 212Y, 212A, 212C, 212D, 212E, 212G, 212H, pump 216, valve 212L, heater 218, patient path 204G, washing path 208D, valve 212K, discharge path 204F, washing path 208B, and disposable priming path 204H, thereby capturing air received from the fluid path and disposable priming path 204H in the water supply bag 223A.

[0082] In the third stage of the air removal mode, the valve 212 is configured as follows:

[0083] [Table 14]

[0084] In the third stage of the air removal mode, the pump 216 circulates water through the water supply path 204A, valve 212Z, bypass path 221, heater 218, valve 212L, pump 216, valve 212I, discharge path 204F, washing path 208B, and disposable priming path 204H, thereby capturing air received from the disposable priming path 204H in the water supply bag 223A.

[0085] Figure 7 is a schematic diagram of the male connector 260A. The male connector 260A comprises a shaft portion 265 having male threads 263 on its outer surface 264. The inner surface of the shaft portion 265 defines a pipe 266 that, where applicable, is securely connected to a water supply path 204A, one of the dialysate supply paths 204B-204E, or a discharge path 204F for fluid communication. The male threads 263 are configured to connect to female threads of an adapter that is connected to one of the dialysate supply bags 223B-223E or a water supply bag 223A.

[0086] The male connector 260A also includes a shroud 267 that surrounds the proximal portion of the shaft 265 so that the distal portion of the shaft 265 extends distally. The male connector 260A also includes a periphery sealing surface 268 proximal to the shroud 267 and a projection 269 proximal to the periphery sealing surface 268. As shown in the figure, the outer surface 264 tapers distally. The male connector 260A is configured for connection at its proximal end 270 to either the water supply path 204A or one of the dialysate supply paths 204B-204E.

[0087] Figure 8 is a schematic diagram of the male connector 260B. The male connector 260B comprises a shaft 265 having an inner surface 272 that defines a tube 266 that is securely connected to and fluid-communicated with the patient pathway 204G. The male connector 260B also comprises a shroud 267 that surrounds the proximal portion of the shaft 265 so that the distal portion of the shaft 265 extends distally. The shroud 267 has male threads 275 on its inner surface that are configured to connect to the female threads of an adapter that will be inserted into the patient's peritoneum. The male connector 260B also comprises a periphery sealing surface 268 proximal to the shroud 267 and a projection 269 proximal to the periphery sealing surface 268. The outer surface of the shaft 265 tapers distally. The male connector 260B is configured at its proximal end 278 for connection to the patient pathway 204G.

[0088] Figure 9 is a collection of schematic diagrams of a female connector 250 and a male connector 260 that may take the form of a male connector 260A or a male connector 260B. The routes 204 and ports 206 shown in Figures 2 to 6 can be connected to each other in various ways. For example, each port 206 may have a female connector 250 sized to accept a specific male connector 260 that terminates the corresponding route 204 (for example, it may terminate at the female connector 250).

[0089] The female connector 250 comprises an opening 252, an O-ring 254 surrounding the opening 252, and a projection 256 positioned around the opening 252. The male connector 260 is configured to connect to the female connector 250 by axially inserting the male connector 260 into the opening 252 such that the projection 269 moves axially over the projection 256, and then rotating the male connector 260 so that the projection 269 moves behind the projection 256. This seals the surrounding sealing surface 268 against the O-ring 254 and exposes the shroud 267 and shaft portion 265 to one of the cleaning paths 208A to 208D. Thus, the shroud 267 and shaft portion 265 are exposed to the hot water of cleaning during the disinfection cycle.

[0090] The female connector 250 includes a sensing ring 257 further comprising permanent magnets 259A and 259B. The sensing ring 257 and permanent magnets 259 are configured to rotate when the male connector 260 is rotated within the opening 252. The female connector 250 further includes a base 281 comprising Hall effect sensors 261A and 261B. The Hall effect sensors 261A and 261B are configured to indicate whether the male connector 260 is properly connected to the female connector 250 based on the rotational position of the permanent magnets 259A and 259B relative to the Hall effect sensors 261A and 261B.

[0091] Figure 10 is a schematic diagram of system 200. System 200 comprises a housing 202 having an external storage surface 302. Typically, the housing 202 is made of metal and is insulated internally to minimize heat loss from the housing 202 during disinfection mode. System 200 further comprises hooks 304 positioned on the external storage surface 302. Water supply path 204A, dialysate supply paths 204B-204E, discharge path 204F, and patient path 204G are configured to wrap around the hooks 304 for storage during disinfection mode of system 200.

[0092] System 200 also includes a lid 306 that is rotatable (e.g., around a hinge) to an open or closed position. Figure 10 shows the open position, in which the pathways 204 and ports 206 are accessible. In the closed position, the pathways 204 and ports 206 are inaccessible. Thus, the lid 306 covers the external storage surface 302, the water supply pathway 204A, the dialysate supply pathways 204B-204E, the discharge pathway 204F, and the patient pathway 204G during the disinfection mode. System 200 is configured to lock the lid 306 so that it cannot be opened during the disinfection mode.

[0093] As illustrated, the system 200 also includes clips 307 positioned between the hooks 304. Each clip 307 is configured to hold a water supply path 204A, one of the dialysate supply paths 204B-204E, a discharge path 204F, or a patient path 204G between the multiple hooks 304 during disinfection mode.

[0094] Figure 11 is a schematic diagram of System 200 as an overview view.

[0095] Figure 12 is a magnified view of the hook 304.

[0096] Figure 13 is a schematic diagram of the lid 306 in the closed position.

[0097] Figures 14–21 are block diagrams of methods 400, 410, 420, 430, 440, 450, 460, and 470, which in some examples are performed by system 200 and / or manually. As shown in Figures 14–21, methods 400–470 include one or more operations, functions, or actions, as illustrated by blocks 402, 404, 412, 414, 422, 424, 432, 434, 442, 444, 452, 454, 462, 464, 466, 468, 472, and 474. Although the blocks are shown in a sequential order, these blocks may be performed in parallel and / or in an order different from the order described herein. Also, the various blocks may be combined into fewer blocks, divided into additional blocks, and / or removed, based on the desired implementation.

[0098] In block 402, method 400 includes the calculation device 100 making the following determinations: (i) that the water supply route 204A is not connected to port 206C; (ii) that the dialysate supply routes 204B-204E are not connected to ports 206A-206B and 206E-206F; (iii) that the discharge route 204F is not connected to port 206D; and (iv) that the patient route 204G is connected to port 206G. The functionality of block 402 is described above with reference to Figure 2.

[0099] In block 404, method 400 includes causing the computing device 100 to operate the system 200 in priming mode in response to a decision. The functionality of block 404 is described earlier with reference to Figure 2.

[0100] In block 412, method 410 includes the calculation device 100 making the following determinations: (i) that the water supply route 204A is not connected to port 206C; (ii) that the dialysate supply routes 204B-204E are not connected to ports 206A-206B and 206E-206F; (iii) that the discharge route 204F is not connected to port 206D; and (iv) that the patient route 204G is not connected to port 206D. The functionality of block 412 is described above with reference to Figure 3.

[0101] In block 414, method 410 includes causing the computing device 100 to operate the system 200 in patient discharge mode in response to a decision. The functionality of block 414 is described earlier with reference to Figure 3.

[0102] In block 422, method 420 includes the calculation device 100 making the following determinations: (i) that the water supply route 204A is not connected to port 206C; (ii) that the dialysate supply routes 204B-204E are not connected to ports 206A-206B and 206E-206F; (iii) that the discharge route 204F is not connected to port 206D; and (iv) that the patient route 204G is not connected to port 206G. The functionality of block 422 is described above with reference to Figure 3.

[0103] In block 424, method 420 includes causing the computing device 100 to operate the system 200 in patient-filling mode in response to a decision. Functionality relating to block 424 is described earlier with reference to Figure 3.

[0104] In block 432, method 430 includes the calculation device 100 making the following determinations: (i) that the water supply route 204A is not connected to port 206C; (ii) that the dialysate supply routes 204B-204E are connected to ports 206A-206B and 206E-206F; (iii) that the discharge route 204F is not connected to port 206D; and (iv) that the patient route 204G is connected to port 206G. The functionality of block 432 is described above with reference to Figure 4.

[0105] In block 434, method 430 includes causing the computing device 100 to operate the system 200 in cleaning mode in response to a decision. The functionality of block 434 is described earlier with reference to Figure 4.

[0106] In block 442, method 440 includes the calculation device 100 making the following determinations: (i) that the water supply route 204A is connected to port 206C; (ii) that the dialysate supply routes 204B-204E are connected to ports 206A-206B and 206E-206F; (iii) that the discharge route 204F is connected to port 206D; and (iv) that the patient route 204G is connected to port 206G. The functionality of block 442 is described above with reference to Figure 5.

[0107] In block 444, method 440 includes causing the computing device 100 to operate the system 200 in disinfection mode in response to a decision. The functionality of block 444 is described earlier with reference to Figure 5.

[0108] In block 452, method 450 includes the calculation device 100 making the following determinations: (i) that the disposable priming route 204H is connected to port 206C; (ii) that the dialysate supply routes 204B-204E are connected to ports 206A-206B and 206E-206F; (iii) that the discharge route 204F is connected to port 206D; and (iv) that the patient route 204G is connected to port 206G. The functionality of block 452 is described above with reference to Figure 6.

[0109] In block 454, method 450 includes causing the computing device 100 to operate the system 200 in air removal mode in response to a decision. The functionality of block 454 is described earlier with reference to Figure 6.

[0110] In block 462, method 460 includes operating system 200 in priming mode, thereby filling system 200 with supply dialysate, while dialysate supply routes 204B-204E are connected to dialysate supply bags 223B-223E and patient route 204G is connected to port 206G. The functionality relating to block 462 is described earlier with reference to Figure 2.

[0111] In block 464, method 460 includes operating system 200 in patient drainage mode while patient pathway 204G is connected to the patient's peritoneum 219, thereby draining used dialysate from the patient's peritoneum 219 through drainage pathway 204F. The functionality relating to block 464 is described earlier with reference to Figure 3.

[0112] In block 466, method 460 includes operating system 200 in patient filling mode, thereby filling the patient's peritoneum 219 with supply dialysate, while patient pathway 204G is connected to the patient's peritoneum 219 and dialysate supply pathways 204B-204E are connected to dialysate supply bags 223B-223E. Functionality relating to block 466 is described earlier with reference to Figure 3.

[0113] In block 468, method 460 includes operating system 200 in flushing mode, thereby filling system 200 with water, while water supply path 204A is connected to water supply bag 223A, dialysate supply paths 204B-204E are connected to ports 206A-206B and 206E-206F, and patient path 204G is connected to port 206G. The functionality relating to block 468 is described earlier with reference to Figure 4.

[0114] In block 472, method 470 includes operating system 200 in disinfection mode, thereby circulating heated water through wash paths 208A-208D, while water supply path 204A is connected to port 206C, dialysate supply paths 204B-204E are connected to ports 206A-206B and 206E-206F, discharge path 204F is connected to port 206D, and patient path 204G is connected to port 206G. The functionality relating to block 472 is described earlier with reference to Figure 5.

[0115] In block 474, method 470 includes operating system 200 in air removal mode, thereby capturing air received from disposable priming path 204H in water supply bag 223A, while water supply path 204A is connected to the first bag port of water supply bag 223A, dialysate supply paths 204B-204E are connected to ports 206A-206B and 206E-206F, disposable priming path 204H is connected to port 206C and the second bag port of water supply bag 223A, discharge path 204F is connected to port 206D, and patient path 204G is connected to port 206G.

[0116] Further Exemplary Embodiments This disclosure relates to the provision of peritoneal dialysis as a treatment for renal failure using an automated device commonly known as a cyclometer. Typically, in peritoneal dialysis, sterile dialysate contained in a plastic bag is injected into the peritoneal cavity via an indwelling catheter. This can be performed manually by gravity or with the use of a cyclometer. The dialysate is left in the peritoneal cavity for a sufficient length of time (e.g., 4 hours) to produce net removal of toxins and water, after which the dialysate is drained and replaced with fresh dialysate.

[0117] A cyclist automates this process. Many modern peritoneal cyclists control this process by interacting with a sterile disposable piping set connected at the import end to multiple supply bags of dialysate, and a discharge route connected to a discharge bag or open discharge port at the export end. Along the way, there is typically some kind of cassette captured at the door of the cyclist. This cassette provides means for delivering dialysate to and from the patient, means for regulating specific piping routes with valves to open and close them as appropriate, and means for measuring or calculating the volume of fluid delivered to and from the patient so that the net amount of water removed from the patient (ultrafiltration) can be calculated. Also most frequently included in the piping set is a plastic bag that is initially empty but, in use, is placed on a platen on top of the cyclist containing a heater, which heats the solution to body temperature for patient comfort when the bag is filled with the initial volume of dialysate.

[0118] Current cyclonica designs generally require numerous electromechanical components and sensors, and as with any instrument, more components mean higher costs, heavier weight, larger dimensions, and lower reliability, all of which negatively impact marketability. The same applies to disposable piping sets; more pipes, connectors, cassettes, and bags mean higher costs, lower reliability, longer installation and removal times, greater space in the living space, and greater space in landfills when discarded. Furthermore, the current method of heating dialysate by placing plastic bags on the heater platen is highly inefficient, as most of the heat is lost to the atmosphere, and heat must be transferred from the platen through the plastic to the liquid.

[0119] The benefit of this disclosure is the design of the cyclorama, which dramatically simplifies the device, thereby reducing all dimensions, weight, cost, and operational complexity, while improving reliability; completely eliminates disposable piping sets and heater bags, thereby reducing per-treatment costs, improving heating efficiency, lowering energy consumption, shortening setup time, reducing complexity, and reducing the number of boxes that patients must store at home, as well as implementing a novel and highly cost-effective method for measuring the volume of dialysate injected into and removed from the patient, and consequently, ultrafiltration.

[0120] This is achieved by making the piping set (fluid passages) semi-permanently and mostly inside the device rather than discarding them daily, and by designing the device to automatically clean and disinfect the flow paths between treatments, so that, broadly speaking, all the patient has to do to start treatment is connect a new supply bag of dialysis fluid and its catheter to the device, connect the discharge route to the discharge port, and press "start".

[0121] Figure 22 discloses a peritoneal dialysis cycla with a reusable fluid passage.

[0122] Figure 23 discloses the cyclora of Figure 22 with bags of sterile water, which are used in the washing and disinfecting processes, attached.

[0123] Figure 24 discloses how the patient connection path is connected to the machine to form a fluid passage to the discharge path.

[0124] Figure 25 discloses a diagram illustrating how the fluid passage is primed with dialysate.

[0125] Figure 26 discloses a diagram illustrating how the initial discharge of dialysate from the patient primes the remaining fluid passage between valves V9 and V10.

[0126] Figure 27 discloses how a pulse of water enables flow rate calculation using the time-of-flight principle of conductivity in discharge mode.

[0127] Figure 28 discloses how the time-of-flight principle of conductivity in the filling mode enables the calculation of water flow rates using pulses.

[0128] Figure 29 discloses how the dialysate supply path is connected to the instrument to form a through-circuit.

[0129] Figure 30 discloses that a sterile water supply source is used to circulate through the through-circuit created in Figure 29 in order to clean the dialysate circuit from the previous treatment.

[0130] Figure 31 discloses how sterile water supply and discharge routes are connected to the instrument to form a through-circuit that recirculates high-temperature water through all fluid passages to achieve disinfection.

[0131] Figure 32 discloses a diagram illustrating one of the disinfection modes, showing how high-temperature water is recirculated through various channels to achieve disinfection.

[0132] This concept is illustrated in Figure 22. The shaded rectangle represents the enclosure; therefore, the piping shown inside the blue rectangle is inside the fixture, while the piping and supply bag outside the rectangle are outside the fixture.

[0133] The materials used for the internal piping structure of the device are inert, biocompatible, and heat-resistant. Examples include PVDF and FEP. This piping is not handled by the patient and does not need to be flexible.

[0134] The piping on the outside of the device needs to be flexible because the patient needs to pull the piping out of the machine at the start of treatment and connect it to either a supply bag, a transfer set (catheter), and possibly a discharge bag. These piping sections will also be involved in the disinfection process, so they must be heat-resistant and biocompatible. As a result, a suitable material for these sections is silicone such as Sani-Tech® STHT®-C.

[0135] The reason why not only these sections of piping but all other fluid-contacting components need to be heat-resistant is that a preferred method for disinfecting the entire flow path is by circulating water heated to at least 80°C for at least one hour. This is a method that achieves the defined term "high-level disinfection," which is approved by the FDA, particularly for the reprocessing of hemodialyzers, and is recognized as killing all plant microorganisms. This method is also used in predicate devices described, for example, in U.S. Patent No. 5591344.

[0136] While the flow channels can be disinfected by other means, such as chemical disinfection methods (e.g., mixtures of peracetic acid and hydrogen peroxide, bleach), ultraviolet light, ozonated water, and other methods known in the art, heat is particularly suitable for this purpose because heat is transmitted through surfaces and can reach bacteria that may be hiding, avoiding contact by chemical disinfection methods or other disinfection means, for example, in couplings or in cracks or gaps in the flow channels constructed from piping connected to other piping, in other sensors and components used in certain devices. This method also avoids the cost of chemical disinfection and the need for patients to handle and be exposed to chemical disinfection methods. The use of automatic extension (as opposed to single-use disposable) of dialysate flow channels used in the implementation of peritoneal dialysis has not been previously described.

[0137] Internal piping, when it terminates on the surface of the enclosure, must be coupled to its corresponding external piping. To minimize gaps in the flow path, pipe couplers that minimize or eliminate dead space in the flow path are desirable, especially when bacteria may be shielded from disinfection. An example is the AVS dead space-free pipe coupler manufactured by AVS Romer GmbH & Co. Grafenau, Germany.

[0138] Romer also manufactures two-way and three-way valves, such as the EAV 800, which feature the same dead-space-free design.

[0139] A water source is required to carry out the disinfection process between treatments. This can be done by attaching a bag of sterile water in the same manner as the dialysis fluid supply bag is attached (Figure 23). Such bags of sterile water are readily available from several suppliers.

[0140] At the end of the heating and cooling cycle, before the instrument is ready to begin the next patient treatment, the sterile water from the previous disinfection cycle must be replaced with fresh dialysate from a newly connected supply bag. This requirement dictates that the patient connection path be connected to the discharge path so that the water contained in the patient connection path can flow to the discharge section and be filled with dialysate. To accomplish this, the receiving section is designed on the surface of the enclosure into which the patient transfer set connector is fitted and locked in place (Figure 24). The system shown in Figure 24 may comprise an inline heater such as a White Knight ultra-high purity PVDF / PVA fluid heater models FH1-FH7, a non-intrusive conductivity sensor such as a Great Lakes Instruments GLI 3046C1T Electrodeless Conductivity Sensor, an ultrasonic air / bubble sensor such as an Introtek AD8 / AD9 series, and an inline pressure sensor with a biocompatible and heat-resistant material structure such as Ashcroft® ZL91.

[0141] The receiving section (TC1) is designed to allow hot water to flow not only around the first few millimeters outside the patient connector but also through the lumen, so that if microorganisms are transferred to the surface by the patient through contact contamination, the microorganisms are killed by the disinfection process. The receiving section TC1 is also designed to allow the patient connector to be operated to lock it in place once the patient connector is fully inserted, so that the patient connector cannot be accidentally dislodged.

[0142] The cycloacupuncture apparatus must include a pump used to deliver dialysate to the patient, to deliver dialysate from the patient, and to recirculate water and dialysate through the fluid passages, depending on the mode of operation. This pump (PU1) can be of many different types, but is not limited to roller peristalsis, linear peristalsis, mechanical or pneumatic diaphragm, axial flow, gear, and centrifugal.

[0143] Heaters are required to heat the dialysate to body temperature and to heat the water to disinfection temperature. However, in this case, since the fluid passage is almost permanent, an in-line heater may be used. To precisely control the temperature using a feedback loop method, temperature sensors such as thermistors are positioned immediately before and after the heater element.

[0144] A conductivity sensor (C1) is added because it is necessary to detect when all of the fluid in the fluid circuit is either all water or all dialysate. This sensor can be of many different designs and can either penetrate the flow path or be non-penetrating, such as the Great Lakes Instruments GLI 3046C1T Electrodeless Conductivity Sensor.

[0145] Occasionally, the fluid passage may be filled with air, such as when the instrument is first used or when a patient travels with the instrument. In those cases, it is necessary to first pump out all the air from the circuit and replace it with fluid, as it must be prevented from injecting air into the patient. It is also possible that one or more of the supply bags remain dry during treatment, allowing air to enter the flow path. An air / bubble sensor is placed immediately before the pump to determine when all air has been removed from the Cairo during priming and to detect empty bags. At that position, if air is detected during treatment, the pump can be stopped and reversed, thereby sending the air back into the bag from which it came, and then the appropriate valve (e.g., V3 when bag #1 is empty) can be closed to prevent further air injection. A sensor typically used for this purpose is ultrasound, such as the Introtek AD8 / AD9 series shown below. Alternatively, the air may be directed beyond valve 212I into the discharge path.

[0146] When using a pump to inject or drain dialysis fluid from a patient, it is necessary to ensure that the positive and negative pressures created do not exceed safety limits. This is ensured by incorporating a pressure sensor in the flow path closest to the patient (P1). Pressure readings from this sensor are continuously sent back to the pump to control the pump speed so that the pressure in the patient's peritoneal cavity remains within a safe range. Here again, since the flow path is semi-permanent and disinfected between each treatment, this pressure sensor can be designed as part of the flow path, in contrast to non-intrusive ones used by most other cycloras, which involve the use of a diaphragm adjacent to the flow path that converts the flow path pressure into an air column in contact with the pressure transducer. An example of an in-line pressure transducer made from an inert, biocompatible material and heat-resistant is the Ashcroft® ZL91.

[0147] To begin treatment, the patient first connects new bags of dialysate and sterile water to their respective supply paths attached to the instrument, and either connects the discharge path to the discharge bag or positions the discharge path to the open discharge section. Once that is complete, the patient begins the priming sequence by selecting the appropriate instructions to a graphical user interface (GUI), which is either integrated with the machine or wirelessly connected to the machine. This instructs the software controlling the instrument to start releasing all water pathways by operating the pumps and opening the appropriate valves to draw dialysate from all attached dialysate supply containers, as shown in Figure 25. The pathway sections extending through valve V9 will be primed during the initial patient discharge.

[0148] The priming mode is terminated when conductivity stabilizes in the valve associated with the prescribed composition of the dialysate. At this point, the GUI instructs the patient to disconnect the patient connection path from the receiving unit TC1 and connect the patient connection path to the patient's catheter / transfer set. Once connected, the patient instructs the GUI to do so, and the instrument enters the initial patient discharge mode as shown in Figure 26.

[0149] In peritoneal dialysis, it is crucial to quantify the volume of fluid entering and leaving the patient between each filling and draining cycle, so that the net amount of fluid removed from the patient can be quantified and reported. This measurement must meet accuracy requirements that are typically more stringent than those that pumps can provide, such as by multiplying the stroke volume by the number of strokes. To achieve this required precision while adding minimal complexity, cost, and weight to the instrument, a novel and precise method for measuring flow rate has been devised in this design.

[0150] Because a water supply source is already present for the disinfection process, and because there is a large difference in conductivity between water and peritoneal dialysis fluid, a Conductivity-Time-Of-Flight (C-TOF) method can be used to accurately determine the flow rate. This is accomplished by adding a conductivity cell (C2) on the opposite side of the pump from C1, as shown in Figure 27, adding a water path from three-way valve V1 through another three-way valve (V11), and connecting it to three-way piping connectors on both the patient side of the pump and C2.

[0151] By quickly opening and closing V11, small pulses of water (e.g., 1 ml every 15 seconds) can be injected into the dialysate flow path, which then passes through C2 and immediately afterward through C1. By knowing the volume of the flow path between C2 and C1, and then determining the time elapsed between the conductivity valleys passing through each conductivity sensor, the flow rate can be accurately calculated. This process can be either continuous (whenever the pump is moving fluid) or discontinuous, if the C-TOF method is only used periodically to calibrate the pump stroke volume. If a verification test proves that the stroke volume remains nearly constant during a given treatment, the pump calibration method can be found to be sufficiently accurate.

[0152] The C-TOF method can also be performed during patient filling mode by adding another piping section between valve V11 and the three-way pipe connector located on the dialysate supply bag side of C1, as shown in Figure 28. Here again, if the stroke volume calibration method is sufficiently accurate, it may not be necessary to perform C-TOF on both sides of the pump.

[0153] Once treatment is complete and the final fill (if prescribed) is received from an optional separate final fill bag, the patient disconnects their patient connection pathway from their catheter / transfer set and reconnects to TC1. The patient then disconnects each dialysate supply bag one by one. Since the supply bag pathways are also designed to be semi-permanent and must be cleaned and disinfected, a means is needed to connect the supply bag piping to a closed-loop recirculation circuit. To achieve this, piping connectors, if not identical to TC1, but very close to it, are implemented on the outer surface of the device as shown in Figure 29 (TC2-TC5). Behind these piping connectors are piping sections that connect each pair of supply pathway pipes to each other, forming a through-circuit.

[0154] Once all dialysate supply tubes are locked in place, the device can begin to drain any remaining dialysate from the fluid passages to the discharge section (Figure 30). Multiple flushing modes may be required to flush out all piping sections. A flushing mode is completed when the conductivity cell stabilizes at the conductivity of sterile water.

[0155] Once all channels have been properly flushed, the final two unconnected paths must be connected to a similar flow-through design so that high-temperature water can be recirculated through all channels. This is accomplished by adding another pair of pipe connectors TC6 and TC7 and connecting the water supply and discharge paths to them, as shown in Figure 31.

[0156] Once all fluid pathways are inserted and locked in place, the circulation of high-temperature water can be initiated. Temperature sensors will ensure that all piping sections are exposed to sufficient heat for a sufficient duration to achieve high-level disinfection, as shown in Figure 32.

[0157] Once a high level of disinfection is achieved, the device will continue to recirculate water, passing it alternately through all pathways, and will not remove the piping until the temperature has cooled to at least 37°C. The piping will be designed so that a door or cover encloses and locks over the piping to ensure that it is isolated and cannot be touched while it is hot. The device will incorporate a sensor in the door latch so as to know when the door is locked in the closed position, indicating that it is safe to start the heat disinfection cycle, and so as to prevent the door from being opened until the temperature has cooled to a safe level.

[0158] Example Enumerated Embodiment (EEE) EEE1 is a system for peritoneal dialysis, comprising a housing, a water supply path, a dialysate supply path, a discharge path, and a patient path, each extending from the housing, a first port, a second port, a third port, and a fourth port accessible from the outside of the housing, the first port configured to connect to the water supply path, the second port configured to connect to the dialysate supply path, the third port configured to connect to the discharge path, and the fourth port configured to connect to the patient path, and a first wash path, a second wash path, and a third wash path, each contained within the housing, the first wash path terminating at the first and third ports, the second wash path terminating at the second port, and the third wash path terminating at the fourth port and the discharge path within the housing, respectively.

[0159] EEE2 is a system of EEE1, wherein the dialysate supply path is the first dialysate supply path, and the system further comprises a second dialysate supply path extending from the housing and a fifth port accessible from the outside of the housing, the fifth port being configured to connect to the second dialysate supply path, and the second cleaning path also terminates at the fifth port.

[0160] EEE3 is a system of EEE1 or 2, wherein the dialysate supply path is a first dialysate supply path, and the system comprises a second dialysate supply path and a third dialysate supply path, each extending from the housing, a fifth port and a sixth port, each accessible from outside the housing, the fifth port configured to connect to the second dialysate supply path and the sixth port configured to connect to the third dialysate supply path, and a fourth cleaning path contained within the housing, the fourth cleaning path terminating at the fifth and sixth ports.

[0161] EEE4 is one of the EEE1-3 systems, wherein the first port comprises a female connector comprising an opening, an O-ring surrounding the opening, and one or more first projections positioned around the opening, and the water supply path terminates at a male connector, the male connector comprising a shaft having male threads on its outer surface, the inner surface of the shaft defining a tube in fluid communication with the water supply path, the male threads being configured to connect to female threads of an adapter for a bag containing the supply dialysate, a shroud surrounding the first portion of the shaft such that a second portion of the shaft extends distally, a peripheral sealing surface proximal to the shroud, and one or more second projections proximal to the peripheral sealing surface.

[0162] EEE5 is a system based on EEE4, with the outer surface tapering distally.

[0163] EEE6 is an EEE4 or EEE5 system, where the male connector is connected to the water supply path at the proximal end of the male connector.

[0164] EEE7 is one of the EEE4-6 systems, and the male connector is configured to connect to the female connector by axially inserting the male connector into the opening such that one or more second projections move over one or more first projections, and rotating the male connector such that one or more second projections move behind one or more first projections, thereby sealing the circumferential sealing surface against the O-ring and exposing the shroud to a first cleaning path.

[0165] EEE8 is a system of EEE7, the female connector comprising a sensing ring having one or more magnets, configured to rotate when a male connector is rotated within an opening, and a base having one or more Hall effect sensors, the one or more Hall effect sensors being configured to indicate whether the male connector is properly connected to the female connector based on a first rotational position of one or more magnets relative to the one or more Hall sensors.

[0166] EEE9 is one of the EEE1-8 systems, wherein the fourth port comprises a female connector comprising an opening, an O-ring surrounding the opening, and one or more first projections positioned around the opening, and the patient pathway terminates at a male connector, which comprises a shaft having a first inner surface defining a tube in fluid communication with the patient pathway, a shroud surrounding the first portion of the shaft such that a second portion of the shaft extends distally, and having a male thread on the second inner surface of the shroud configured to connect to a female thread of an adapter for a catheter, a circumferential sealing surface proximal to the shroud, and one or more second projections proximal to the circumferential sealing surface.

[0167] EEE10 is a system based on EEE9, but the outer surface of the shaft tapers distally.

[0168] EEE11 is a system of EEE9 or 10, where the male connector connects to the patient pathway at the proximal end of the male connector.

[0169] EEE12 is one of the EEE9-11 systems, and the male connector is configured to connect to the female connector by inserting the male connector axially into the opening such that one or more second projections move over one or more first projections, and by rotating the male connector such that one or more second projections move behind one or more first projections, thereby sealing the surrounding sealing surface against the O-ring and exposing the shroud to a third cleaning path.

[0170] EEE13 is a system of EEE12, the female connector comprising a sensing ring having one or more magnets and configured to rotate when a male connector is rotated in an opening, and a base having one or more Hall effect sensors, the one or more Hall effect sensors being configured to indicate whether the male connector is properly connected to the female connector based on a first rotational position of one or more magnets relative to the one or more Hall effect sensors.

[0171] EEE14 is one of the EEE1-13 systems, further comprising one or more valves and a pump.

[0172] EEE15 is a system of EEE14, configured to operate in priming mode, with a patient pathway connected to a fourth port, and one or more valves configured to cause the pump to draw in the dialysis fluid through the dialysis fluid supply pathway and push the dialysis fluid through the patient pathway, a third flush pathway, and a discharge pathway.

[0173] EEE16 is one of the EEE14-15 systems, configured to operate in patient discharge mode, with a patient pathway connected to the patient's peritoneum, and one or more valves configured to cause a pump to draw used dialysate through the patient pathway and push the used dialysate through the discharge pathway.

[0174] EEE17 is one of the EEE14-16 systems, configured to operate in patient-filling mode, with a patient pathway connected to the patient's peritoneum, and one or more valves configured to cause a pump to draw in the dialysis fluid through the dialysis fluid supply pathway and push the dialysis fluid through the patient pathway into the patient's peritoneum.

[0175] EEE18 is one of the EEE14-17 systems, configured to operate in the first stage of the washing mode, with a dialysate supply path connected to the second port, a patient path connected to the fourth port, and one or more valves configured to cause the pump to draw water through the water supply path and push the water through the patient path, the third washing path, and the discharge path.

[0176] EEE19 is a system of EEE18, configured to operate in the second stage of the washing mode, with a dialysate supply path connected to a second port and a patient path connected to a fourth port, and one or more valves configured to cause the pump to draw water through the water supply path, the second washing path, and the fourth washing path, and to push the water through the patient path, the third washing path, and the discharge path.

[0177] EEE20 is a system of EEE19, further comprising a bypass route connecting the water supply route to the patient route, configured to operate in the third stage of the washing mode, wherein the dialysate supply route is connected to the second port, the patient route is connected to the fourth port, and one or more valves are configured to cause the pump to draw water through the water supply route and the bypass route, and to push the water through the patient route, the third washing route, and the discharge route.

[0178] EEE21 is one of the EEE14-20 systems, the system further comprising a heater and configured to operate in the first stage of disinfection mode, the water supply path connected to the first port, the dialysate supply path connected to the second port, the discharge path connected to the third port, the patient path connected to the fourth port, one or more valves configured to circulate water to the pump so as to circulate water through the water supply path, heater, patient path, third wash path, discharge path, and first wash path and return to the water supply path, and the heater is configured to heat the water passing through the heater.

[0179] EEE22 is a system of EEE21, configured to operate in the second stage of disinfection mode, with a water supply path connected to the first port, a dialysate supply path connected to the second port, a discharge path connected to the third port, a patient path connected to the fourth port, and one or more valves configured to circulate water to the pump through the water supply path, dialysate supply path, second wash path, fourth wash path, heater, patient path, third wash path, discharge path, and first wash path, and return to the water supply path, and the heater configured to heat the water passing through the heater.

[0180] EEE23 is a system of EEE22, the system further comprising a bypass route connecting the water supply route to the patient route, configured to operate in the third stage of disinfection mode, the water supply route being connected to port 1, the dialysate supply route being connected to port 2, the discharge route being connected to port 3, the patient route being connected to port 4, one or more valves configured to circulate water to the pump so as to circulate water through the water supply route, bypass route, heater, discharge route and first wash route and return to the water supply route, and the heater is configured to heat the water passing through the heater.

[0181] EEE24 is a system which is one of the systems EEE14-23 and further comprises a water supply bag and a disposable priming path, and is configured to operate in the first stage of air removal mode, wherein the water supply path is connected to the first bag port of the water supply bag, the dialysate supply path is connected to the second port, the disposable priming path is connected to the first port and the second bag port of the water supply bag, the discharge path is connected to the third port, the patient path is connected to the fourth port, and one or more valves are configured to circulate water to the pump through the water supply path, patient path, third wash path, discharge path, first wash path and disposable priming path, thereby capturing air received from the disposable priming path in the water supply bag.

[0182] EEE25 is a system of EEE24, configured to operate in the second stage of air removal mode, with a water supply path connected to the first bag port of the water supply bag, a dialysate supply path connected to the second port, a disposable priming path connected to the first port and the second bag port of the water supply bag, a discharge path connected to the third port, a patient path connected to the fourth port, and one or more valves are configured to circulate water to the pump through the water supply path, dialysate supply path, second wash path, fourth wash path, patient path, third wash path, discharge path, first wash path, and disposable priming path, thereby capturing air received from the disposable priming path in the water supply bag.

[0183] EEE26 is a system of EEE25, further comprising a bypass route connecting a water supply route to a patient route, configured to operate in a third stage of air removal mode, wherein the water supply route is connected to a first bag port of a water supply bag, the dialysate supply route is connected to a second port, the disposable priming route is connected to the first port and the second bag port of the water supply bag, the discharge route is connected to a third port, the patient route is connected to a fourth port, and one or more valves are configured to circulate water to a pump through the water supply route, bypass route, discharge route, first wash route, and disposable priming route, thereby capturing air received from the disposable priming route in the water supply bag.

[0184] EEE27 is one of the EEE1 to 26 systems, wherein the housing has an external storage surface, and the system further comprises a plurality of hooks positioned on the external heating surface, configured to wrap around the water supply route, dialysate supply route, discharge route, and patient route for storage during disinfection procedures, and a lid configured to cover the external storage surface, water supply route, dialysate supply route, discharge route, and patient route during disinfection procedures.

[0185] EEE28 is a system of EEE27, further comprising multiple clips configured to hold water supply routes, dialysate supply routes, discharge routes, and patient routes between multiple hooks.

[0186] EEE29 is one of the EEE27-28 systems and is configured to lock the lid so that it cannot be opened during disinfection procedures.

[0187] EEE30 is a system of EEE1, further comprising a water supply path, a dialysate supply path, a discharge path, a patient path, a first port, a second port, a third port, a fourth port, a first wash path, a second wash path, and a heater configured to heat the liquid passing through the third wash path.

[0188] EEE31 is a method for operating one of the EEE1 to 30 systems, comprising the steps of: determining that (i) the water supply route is not connected to the first port; (ii) the dialysate supply route is not connected to the second port; (iii) the discharge route is not connected to the third port; and (iv) the patient route is connected to the fourth port; and in response to the determination, operating the system in priming mode.

[0189] EEE32 is a method for operating one of the EEE1 to 30 systems, comprising the steps of: determining that (i) the water supply route is not connected to the first port; (ii) the dialysate supply route is not connected to the second port; (iii) the discharge route is not connected to the third port; and (iv) the patient route is not connected to the fourth port; and in response to the determination, operating the system in patient discharge mode.

[0190] EEE33 is a method for operating one of the EEE1 to 30 systems, comprising the steps of: determining that (i) the water supply route is not connected to the first port; (ii) the dialysate supply route is not connected to the second port; (iii) the discharge route is not connected to the third port; and (iv) the patient route is not connected to the fourth port; and in response to the determination, operating the system in patient-filled mode.

[0191] EEE34 is a method for operating one of the EEE1 to 30 systems, comprising the steps of: determining that (i) the water supply route is not connected to the first port; (ii) the dialysate supply route is connected to the second port; (iii) the discharge route is not connected to the third port; and (iv) the patient route is connected to the fourth port; and in response to the determination, operating the system in cleaning mode.

[0192] EEE35 is a method for operating one of the EEE1-30 systems, comprising the steps of: determining that (i) a water supply route is connected to the first port; (ii) a dialysate supply route is connected to the second port; (iii) a discharge route is connected to the third port; and (iv) a patient route is connected to the fourth port; and in response to the determination, operating the system in disinfection mode.

[0193] EEE36 is the method of EEE35, further comprising the step of disabling the heater in response to the determination that a threshold period has elapsed while operating in disinfection mode.

[0194] EEE37 is a method for operating one of the EEE1 to 30 systems, comprising the steps of: determining that (i) a disposable priming path is connected to the first port; (ii) a dialysate supply path is connected to the second port; (iii) a discharge path is connected to the third port; and (iv) a patient path is connected to the fourth port; and in response to the determination, operating the system in air removal mode.

[0195] EEE38 is a method for operating one of the EEE1-30 systems, comprising the steps of: operating the system in priming mode while the dialysate supply route is connected to the dialysate supply bag and the patient route is connected to the fourth port, thereby filling the system with dialysate; operating the system in patient discharge mode while the patient route is connected to the patient's peritoneum, thereby draining used dialysate from the patient's peritoneum through the discharge route; operating the system in patient filling mode while the patient route is connected to the patient's peritoneum and the dialysate supply route is connected to the dialysate supply bag, thereby filling the patient's peritoneum with dialysate; and operating the system in washing mode while the water supply route is connected to the water supply bag, the dialysate supply route is connected to the second port, and the patient route is connected to the fourth port, and The process includes the steps of: filling the system with water; operating the system in disinfection mode while a water supply path is connected to a first port, a dialysate supply path is connected to a second port, a discharge path is connected to a third port, and a patient path is connected to a fourth port, thereby circulating heated water through a first wash path, a second wash path, and a third wash path; and operating the system in air removal mode while a water supply path is connected to a first bag port of a water supply bag, a dialysate supply path is connected to a second port, a disposable priming path is connected to a first port and a second bag port of a water supply bag, a discharge path is connected to a third port, and a patient path is connected to a fourth port, thereby capturing air received from the disposable priming path in the water supply bag.

[0196] Various examples and embodiments are disclosed herein, but other examples and embodiments will be apparent to those skilled in the art. The various examples and embodiments disclosed herein are for illustrative purposes only and are not intended to be limiting, and the true scope and spirit are indicated by the following claims. [Explanation of symbols]

[0197] 100, 100A, 100B Computing devices, 102 Processing units, 104 Non-temporary computer-readable media, 106 Communication interfaces, 108 User interfaces, 111 Instructions, 112 Connection mechanisms, 200 System, 202 Enclosure, 204A Water supply path, 204B, 204C, 204D, 204E Dialysis fluid supply path, 204F Discharge path, 204G Patient path, 206A, 206B, 206C, 206D, 206E, 206F Ports, 208A, 208B, 208C, 208D Washing paths, 212A, 212B, 212C, 212D, 212E, 212F, 212G, 212H, 212I, 212J, 212K, 212L, 212Y, 212Z Valve, 214 Turbidity sensor, 216 Pump, 218 Heater, 219 Peritoneum, 220A,220B Temperature sensor, 221 Bypass path, 223A Water supply bag, 223B,223C,223D,223E Dialysis fluid supply bag, 250 Female connector, 252 Opening, 254 O-ring, 256 Projection, 257 Sensing ring, 259,259A,259B Permanent magnet, 260,260A,260B Male connector, 261A,261B Hall effect sensor, 263 Male thread, 264 Outer surface, 265 Shaft, 266 Tube, 267 Shroud, 268 Surrounding sealing surface, 269 Projection, 270 Proximal end, 272 Inner surface, 275 Male thread, 278 Proximal end, 281 Base, 291 Conductivity sensor, 302 External storage surface, 306 Cover, 307 Clip, C1, C2 Conductivity sensors, PU1 Pump, TC1, TC2, TC3, TC4, TC5, TC6, TC7 Receiving part, Pipe connector, V1, V10, V11 Three-way valve, V2, V3, V4, V5, V6, V7, V8, V9 Valve

Claims

1. A system for peritoneal dialysis, - The casing and, - Water supply path, dialysate supply path, discharge path, and patient path extending from the housing, - A first port, a second port, a third port, and a fourth port that are accessible from the outside of the enclosure, The first port is configured to be connected to the water supply path, The second port is configured to be connected to the dialysate supply path. The third port is configured to connect to the discharge path, The fourth port is configured to connect to the patient pathway. The first port, the second port, the third port, and the fourth port, - A first cleaning path, a second cleaning path, and a third cleaning path, each included within the aforementioned housing, The first cleaning path terminates at the first port and the third port. The second cleaning path terminates at the second port. The third cleaning path terminates within the housing at the fourth port and the discharge path. A first cleaning path, a second cleaning path, and a third cleaning path, A system that includes these features.

2. The aforementioned dialysate supply route is the first dialysate supply route, The aforementioned system, - A second dialysate supply path extending from the housing, - A fifth port accessible from the outside of the housing, configured to be connected to the second dialysate supply path, Equipped with, The system according to claim 1, wherein the second cleaning path also terminates at the fifth port.

3. The aforementioned dialysate supply route is the first dialysate supply route, The aforementioned system, - A second dialysate supply path and a third dialysate supply path extending from the housing, - A fifth port and a sixth port, each accessible from the outside of the enclosure, The fifth port is configured to be connected to the second dialysate supply path. The sixth port is configured to be connected to the third dialysate supply path. The fifth port and the sixth port, - A fourth cleaning path included in the housing, the fourth cleaning path terminating at the fifth port and the sixth port, The system according to claim 1 or 2, further comprising:

4. The first port is equipped with a female connector, The aforementioned female connector is Opening and, An O-ring surrounding the aforementioned opening, One or more first protrusions arranged around the opening and Equipped with, The water supply path terminates at the male connector. The aforementioned male connector is A shaft having male threads on its outer surface, wherein the inner surface of the shaft defines a pipe that is in fluid communication with the water supply path, and the male threads are configured to connect with female threads of an adapter for a bag containing the supply dialysis fluid, A shroud surrounding the first portion of the shaft such that the second portion of the shaft extends distally, The peripheral sealing surface of the shroud, One or more second protrusions proximal to the surrounding sealing surface, A system according to any one of claims 1 to 3, comprising:

5. The system according to claim 4, wherein the outer surface is tapered distally.

6. The system according to claim 4 or 5, wherein the male connector is connected to the water supply path at the proximal end of the male connector.

7. The aforementioned male connector is Inserting the male connector axially into the opening such that one or more of the second protrusions move beyond one or more of the first protrusions, The male connector is rotated so that one or more of the second protrusions move behind one or more of the first protrusions, thereby bringing the surrounding sealing surface into contact with the O-ring for sealing, and exposing the shroud to the first cleaning path, by, The system according to any one of claims 4 to 6, configured to be connected to the female connector.

8. The aforementioned female connector is A detection ring comprising one or more magnets, wherein the detection ring is configured to rotate when the male connector is rotated within the opening, A base equipped with one or more Hall effect sensors, Equipped with, The system according to claim 7, wherein one or more Hall effect sensors are configured to indicate whether the male connector is properly connected to the female connector based on the first rotational position of one or more magnets relative to the one or more Hall effect sensors.

9. The fourth port is equipped with a female connector, The aforementioned female connector is Opening and, An O-ring surrounding the aforementioned opening, One or more first protrusions arranged around the opening, Equipped with, The aforementioned patient pathway terminates at the male connector, The aforementioned male connector has, A shaft portion having a first inner surface that defines a tube in fluid communication with the patient pathway, A shroud that surrounds the first portion of the shaft such that the second portion of the shaft extends distally, and the shroud has a male thread on its second inner surface that is configured to connect with the female thread of an adapter for a catheter. The peripheral sealing surface of the shroud, One or more second protrusions proximal to the surrounding sealing surface, A system according to any one of claims 1 to 8, comprising:

10. The system according to claim 9, wherein the outer surface of the shaft portion is tapered distally.

11. The system according to claim 9 or 10, wherein the male connector is connected to the patient pathway at the proximal end of the male connector.

12. The aforementioned male connector is Inserting the male connector axially into the opening such that one or more of the second protrusions move beyond one or more of the first protrusions, The male connector is rotated so that one or more of the second protrusions move behind one or more of the first protrusions, thereby bringing the surrounding sealing surface into contact with the O-ring for sealing, and exposing the shroud to the third cleaning path, The system according to any one of claims 9 to 11, configured to be connected to the female connector by means of the device.

13. The aforementioned female connector is A detection ring comprising one or more magnets, wherein the detection ring is configured to rotate when the male connector is rotated within the opening, A base equipped with one or more Hall effect sensors, Equipped with, The system according to claim 12, wherein one or more Hall effect sensors are configured to indicate whether the male connector is properly connected to the female connector based on the first rotational position of one or more magnets relative to the one or more Hall effect sensors.

14. One or more valves, Pump and The system according to any one of claims 1 to 13, further comprising:

15. The system is configured to operate in priming mode, In the aforementioned priming mode, The patient pathway is connected to the fourth port, The system according to claim 14, wherein one or more valves are configured to cause the pump to draw in the dialysis fluid through the dialysis fluid supply path and to push the dialysis fluid through the patient path, the third washing path, and the discharge path.

16. The system is configured to operate in patient discharge mode. In the aforementioned patient discharge mode, The aforementioned patient pathway is connected to the patient's peritoneum, The system according to claim 14 or 15, wherein one or more valves are configured to cause the pump to draw in used dialysis fluid through the patient pathway and to push the used dialysis fluid through the discharge pathway.

17. The system is configured to operate in patient filling mode. In the aforementioned patient filling mode, The aforementioned patient pathway is connected to the patient's peritoneum, The system according to any one of claims 14 to 16, wherein one or more valves are configured to cause the pump to draw in the dialysis fluid through the dialysis fluid supply path and to push the dialysis fluid through the patient path into the patient's peritoneum.

18. The system is configured to operate in the first stage of the cleaning mode. In the first stage of the aforementioned cleaning mode, The dialysate supply path is connected to the second port, The patient pathway is connected to the fourth port, The system according to any one of claims 14 to 17, wherein one or more valves are configured to cause the pump to draw water through the water supply path and to push the water through the patient path, the third washing path, and the discharge path.

19. The system is configured to operate in the second stage of the cleaning mode, In the second stage of the aforementioned cleaning mode, The dialysate supply path is connected to the second port, The patient pathway is connected to the fourth port, The system according to claim 18, wherein one or more valves are configured to cause the pump to draw water through the water supply path, the second cleaning path, and the fourth cleaning path, and to push the water through the patient path, the third cleaning path, and the discharge path.

20. The system further comprises a bypass route connecting the water supply route to the patient route, The system is configured to operate in the third stage of the cleaning mode, In the third stage of the aforementioned cleaning mode, The dialysate supply path is connected to the second port, The patient pathway is connected to the fourth port, The system according to claim 19, wherein one or more valves are configured to cause the pump to draw water through the water supply path and the bypass path, and to push the water through the patient path, the third washing path, and the discharge path.

21. The system further comprises a heater, The system is configured to operate in the first stage of the disinfection mode. In the first stage of the aforementioned disinfection mode, The water supply path is connected to the first port, The dialysate supply path is connected to the second port, The aforementioned discharge path is connected to the third port, The patient pathway is connected to the fourth port, One or more of the valves are configured to circulate water to the pump through the water supply path, the heater, the patient path, the third cleaning path, the discharge path, and the first cleaning path, and return it to the water supply path. The system according to any one of claims 14 to 20, wherein the heater is configured to heat the water passing through the heater.

22. The system is configured to operate in the second stage of the disinfection mode, In the second stage of the aforementioned disinfection mode, The water supply path is connected to the first port, The dialysate supply path is connected to the second port, The aforementioned discharge path is connected to the third port, The patient pathway is connected to the fourth port, One or more of the valves are configured to circulate water to the pump through the water supply path, the dialysate supply path, the second cleaning path, the fourth cleaning path, the heater, the patient path, the third cleaning path, the discharge path, and the first cleaning path, and return it to the water supply path. The system according to claim 21, wherein the heater is configured to heat the water passing through the heater.

23. The system further comprises a bypass route connecting the water supply route to the patient route, The system is configured to operate in the third stage of the disinfection mode, In the third stage of the aforementioned disinfection mode, The water supply path is connected to the first port, The dialysate supply path is connected to the second port, The aforementioned discharge path is connected to the third port, The patient pathway is connected to the fourth port, One or more of the valves are configured to circulate water to the pump through the water supply path, the bypass path, the heater, the discharge path, and the first cleaning path, and return the water to the water supply path. The system according to claim 22, wherein the heater is configured to heat the water passing through the heater.

24. The system further comprises a water supply bag and a disposable priming path. The system is configured to operate in the first stage of the air removal mode. In the first stage of the air removal mode, The water supply path is connected to the first bag port of the water supply bag. The dialysate supply path is connected to the second port, The disposable priming path is connected to the first port and the second bag port of the water supply bag. The aforementioned discharge path is connected to the third port, The patient pathway is connected to the fourth port, The system according to any one of claims 14 to 23, wherein one or more valves are configured to circulate water to the pump through the water supply path, the patient path, the third cleaning path, the discharge path, the first cleaning path, and the disposable priming path, thereby capturing air received from the disposable priming path in the water supply bag.

25. The system is configured to operate in the second stage of the air removal mode, In the second stage of the air removal mode, The water supply path is connected to the first bag port of the water supply bag. The dialysate supply path is connected to the second port, The disposable priming path is connected to the first port and the second bag port of the water supply bag. The aforementioned discharge path is connected to the third port, The patient pathway is connected to the fourth port, The system according to claim 24, wherein one or more valves are configured to circulate water to the pump through the water supply path, the dialysate supply path, the second washing path, the fourth washing path, the patient path, the third washing path, the discharge path, the first washing path, and the disposable priming path, thereby capturing air received from the disposable priming path in the water supply bag.

26. The system further comprises a bypass route connecting the water supply route to the patient route, The system is configured to operate in the third stage of the air removal mode, In the third stage of the air removal mode, The water supply path is connected to the first bag port of the water supply bag. The dialysate supply path is connected to the second port, The disposable priming path is connected to the first port and the second bag port of the water supply bag. The aforementioned discharge path is connected to the third port, The patient pathway is connected to the fourth port, The system according to claim 25, wherein one or more valves are configured to circulate water to the pump through the water supply path, the bypass path, the discharge path, the first cleaning path, and the disposable priming path, thereby capturing air received from the disposable priming path in the water supply bag.

27. The aforementioned enclosure is equipped with an external storage surface, The aforementioned system, A plurality of hooks arranged on an external heating surface, wherein the water supply path, the dialysate supply path, the discharge path, and the patient path are wrapped around the hooks for storage during disinfection procedures, A lid is configured to cover the external storage surface, the water supply path, the dialysis fluid supply path, the discharge path, and the patient path during the disinfection procedure. The system according to any one of claims 1 to 26, further comprising:

28. The system according to claim 27, further comprising a plurality of clips configured to hold the water supply path, the dialysate supply path, the discharge path, and the patient path between a plurality of hooks.

29. The system according to claim 27 or 28, wherein the lid is configured to be locked so that it cannot be opened during the disinfection procedure.

30. The system according to claim 1, further comprising a heater configured to heat the liquid passing through the water supply path, the dialysate supply path, the discharge path, the patient path, the first port, the second port, the third port, the fourth port, the first cleaning path, the second cleaning path, and the third cleaning path.

31. A method for operating the system according to any one of claims 1 to 30, (i) the water supply path is not connected to the first port, (ii) the dialysate supply path is not connected to the second port, (iii) the discharge path is not connected to the third port, and (iv) the patient path is connected to the fourth port; In response to the aforementioned decision, the system is operated in priming mode, Methods that include...

32. A method for operating the system according to any one of claims 1 to 30, (i) the water supply path is not connected to the first port, (ii) the dialysate supply path is not connected to the second port, (iii) the discharge path is not connected to the third port, and (iv) the patient path is not connected to the fourth port. In response to the aforementioned decision, the system is operated in patient discharge mode, Methods that include...

33. A method for operating the system according to any one of claims 1 to 30, (i) the water supply path is not connected to the first port, (ii) the dialysate supply path is not connected to the second port, (iii) the discharge path is not connected to the third port, and (iv) the patient path is not connected to the fourth port. In response to the aforementioned decision, the system is operated in patient filling mode, Methods that include...

34. A method for operating the system according to any one of claims 1 to 30, (i) the water supply path is not connected to the first port, (ii) the dialysate supply path is connected to the second port, (iii) the discharge path is not connected to the third port, and (iv) the patient path is connected to the fourth port, In response to the aforementioned decision, the system is operated in cleaning mode, Methods that include...

35. A method for operating the system according to any one of claims 1 to 30, (i) determining that the water supply path is connected to the first port, (ii) determining that the dialysate supply path is connected to the second port, (iii) determining that the discharge path is connected to the third port, and (iv) determining that the patient path is connected to the fourth port, In response to the aforementioned decision, the system is operated in disinfection mode, Methods that include...

36. The method according to claim 35, further comprising the step of disabling the heater in response to a determination that a threshold period has elapsed while operating in the disinfection mode.

37. A method for operating the system according to any one of claims 1 to 30, (i) determining that the disposable priming path is connected to the first port, (ii) determining that the dialysate supply path is connected to the second port, (iii) determining that the discharge path is connected to the third port, and (iv) determining that the patient path is connected to the fourth port, In response to the aforementioned decision, the system is operated in air removal mode, Methods that include...

38. A method for operating the system according to any one of claims 1 to 30, The steps include: operating the system in priming mode while the dialysate supply path is connected to the dialysate supply bag and the patient path is connected to the fourth port, thereby filling the system with dialysate; The steps include operating the system in patient discharge mode while the patient pathway is connected to the patient's peritoneum, thereby discharging the used dialysis fluid from the patient's peritoneum through the discharge pathway, The steps include: operating the system in patient filling mode while the patient pathway is connected to the patient's peritoneum and the dialysate supply pathway is connected to the dialysate supply bag, thereby filling the patient's peritoneum with the supplied dialysate; The steps include: operating the system in cleaning mode and thereby filling the system with water while the water supply path is connected to the water supply bag, the dialysis fluid supply path is connected to the second port, and the patient path is connected to the fourth port; The steps include operating the system in disinfection mode while the water supply path is connected to the first port, the dialysate supply path is connected to the second port, the discharge path is connected to the third port, and the patient path is connected to the fourth port, thereby circulating the heated water through the first washing path, the second washing path, and the third washing path, The steps include operating the system in air removal mode while the water supply path is connected to the first bag port of the water supply bag, the dialysate supply path is connected to the second port, the disposable priming path is connected to the first port and the second bag port of the water supply bag, the discharge path is connected to the third port, and the patient path is connected to the fourth port, thereby capturing air received from the disposable priming path in the water supply bag, Methods that include...

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