System and method for peritoneal dialysis exchange with reusable activation unit

Abstract

To provide a system and a method for receiving peritoneal dialysis treatment without holding unused dialysis solution in a walk-in type facility.SOLUTION: The facility receives the peritoneal dialysis prescription from the patient, validates the prescription, determines the appropriate treatment for the patient, provides the patient with the appropriate dialysis solution in the appropriate amount, and administers the dialysis treatment to the patient at the facility. The facility monitors the patient's home dialysis treatment and adjusts the patient's treatment. The facility produces the dialysis solution on demand by manufacturing the solution from solution components according to the patient's prescription. The facility uses a sorbent system to regenerate effluent dialysis solution into fresh dialysis solution. One embodiment of a peritoneal dialysis system includes a fill container and an actuation unit removably receiving the fill container and including a sterilization source constructed and arranged relative to the fill container when received by the actuation unit to place fluid therein in a physiologically safe condition for delivery to the peritoneal cavity of a patient.SELECTED DRAWING: Figure 8A

Description

[Technical Field]

[0001] This disclosure relates to peritoneal dialysis treatment, and more particularly to systems and methods that enable convenient and inexpensive peritoneal dialysis treatment for multiple patients at a single location. [Background technology]

[0002]

[0002] Many people suffer from kidney disease, a condition in which the kidneys do not properly filter toxins and waste products from the blood. Kidney failure can lead to water and mineral imbalances in the blood and tissues, as well as the accumulation of toxic end products of nitrogen metabolism (e.g., urea, creatinine, uric acid, etc.). Individuals with impaired kidneys cannot survive without replacing at least the filtration function of the kidneys.

[0003] Various forms of dialysis therapy are used to treat patients with kidney disease. One form of dialysis therapy is hemodialysis, in which a patient's blood is passed through an artificial kidney dialysis machine, purified, and then returned to the patient. Because hemodialysis is an extracorporeal procedure, there are certain limitations associated with the treatment. For example, treatments typically last several hours and are generally performed about three times each week at a treatment center.

[0004] A second form of dialysis treatment is peritoneal dialysis, which uses the patient's own peritoneal membrane as a semipermeable membrane rather than an artificial kidney. One advantage to peritoneal dialysis is that patients can receive treatment at home without visiting a medical facility or utilizing the expensive equipment associated with hemodialysis treatment.

[0005] When a patient undergoes peritoneal dialysis treatment, dialysis solution is periodically infused into the peritoneal membrane through an implanted catheter. Diffusion and osmosis exchange occurs across the natural body membrane between the dialysis solution and the bloodstream to remove water, toxins, and waste products normally excreted by the kidneys. After a period of time, the spent dialysis solution is drained from the peritoneal membrane and replaced with fresh fluid. The period of time that the dialysis solution remains in the patient's peritoneal membrane is called the dwell time.

[0006]

[0006] Generally, there are two types of peritoneal dialysis treatments: automated peritoneal dialysis ("APD") and continuous ambulatory peritoneal dialysis ("CAPD"). APD uses a dialysis machine to drain, fill, and dwell dialysis solution against the peritoneal membrane through an implanted catheter. Several drain, fill, and dwell cycles are typically performed while the patient is connected to the dialysis machine. A major advantage of APD is that it is hands-free for the patient, and therefore can be performed at night while the patient sleeps, freeing the patient up during the day.

[0007] In CAPD, dialysis solution is manually introduced into the peritoneum through an implanted catheter. During a dwell time, solute exchange is achieved between the dialysis solution and the blood. After this exchange is achieved, the patient manually drains the dialysis solution from the peritoneum and manually replaces the drained solution with fresh fluid. This process is repeated per the physician's prescription. One advantage of CAPD is that the patient does not need a device, as gravity is used to fill and drain the dialysis solution.

[0008] Whether a patient is on APD or CAPD, their prescription may require a daytime exchange. During a daytime exchange, the patient drains used dialysate from the patient's peritoneum and fills it with an unused supply of dialysate. Daytime exchanges can be particularly cumbersome for patients who work. If the patient cannot return home, the patient must find a location at work to perform the procedure. Solutions and disposables needed to perform the procedure must also be available at the workplace. The transfer and storage of materials and the procedure can be awkward or embarrassing for the patient.

[0009]

[0009] Therefore, there is a need for improved peritoneal dialysis treatments, particularly for single exchanges such as daytime exchanges. Summary of the Invention

[0010]

[0010] The present disclosure addresses these and other needs by providing a system and method that allows multiple patients to receive peritoneal dialysis treatment at a remote location, eliminating the need for patients to store unused dialysis solution and related supplies at home or work. The system and method are useful, for example, for patients who do not have time to return home to perform dialysis treatment during the day. The system and method are also useful for patients in developing countries and low-income areas who do not have access to or the means to have a dedicated home dialysis machine. The system and method can also provide effective peritoneal dialysis treatment to multiple patients in a convenient and cost-effective manner. For example, the system and method may allow patients to stop by a facility according to the present disclosure on their way to or from work, between work shifts, or in between or in connection with other daily activities, making it suitable for use by patients with busy work or daily schedules. Busy patients can use a home device in conjunction with a facility according to the present disclosure to optimize their time, for example, by visiting the facility for a fill (or drain and fill) session and then performing a subsequent drain (or drain and fill) session when they return home at some later time.

[0011] The system and method include a facility. The facility includes multiple peritoneal dialysis treatment stations or multiple peritoneal dialysis treatment rooms. Each treatment station or room is capable of performing one or more peritoneal dialysis patient exchanges. The dialysis stations or rooms are equipped with electronic and / or entertainment devices, such as televisions, computers, headphones, tablets, internet access, and the like, to enable patients to be entertained or to perform work during the exchange (and for extended periods if the patient performs multiple exchanges). Thus, a patient can leave work, go to the facility, and perform an exchange while continuing to work by logging into the patient's internal work website.

[0012] Alternatively, the facility can be located at a workplace, allowing patients to conveniently receive treatment before, during, or after work without disrupting their work schedule. Alternatively, the facility can be located in or near a residence, a train station, bus station, or airport, or a hostel or other temporary accommodation location, for example, so that residents can conveniently receive treatment without having to own their own dialysis equipment or store their own disposable supplies. Such facilities are particularly useful in developing countries where the majority of residents do not have access to dedicated home dialysis machines. Some countries (e.g., Asia) provide temporary accommodation locations near workplaces so that employees can live near their workplaces during the week and return home on weekends. The facility of the present disclosure can be located at or near any such temporary accommodation location.

[0013] It is contemplated that each facility will have a front desk or entry area. Patient visits to the facility may be by appointment and / or accommodate walk-in business. In some embodiments, the patient possesses a computer-readable medium containing the patient's therapy prescription or other patient identifier that allows verification of the patient's prescription. Once verified, the patient is permitted into the facility's treatment area, connected to the correct type of filling device (e.g., batch or bagged), and provided with the prescribed disposable supplies. The patient then proceeds to a designated exchange station, which may be screened, for example, by a curtain or cubicle divider.

[0014] The exchange station can include an automated peritoneal dialysis ("APD") machine, such as the HomeChoice™ or HomeChoicePro™ machines offered by the assignee of the present disclosure. Alternatively, the station can be configured to provide continuous ambulatory peritoneal dialysis ("CAPD") therapy. In some embodiments, a facility offers both in-center APD and CAPD stations that meet the requirements of any operational dialysis prescription.

[0015] Disposable sets are used for both APD and CAPD therapy. APD disposable sets typically require a disposable pump cassette that is coupled to and operated by the APD device. The disposable cassette has multiple tubes connected to it. These tubes connect to the patient, a drain, and one or more supply bags of peritoneal dialysis solution or dialysate. CAPD disposable sets are typically simpler because they do not require machine interaction. The set includes multiple tubes for connection to the patient, a drain, and one or more dialysis fluid supplies. The set may use manually operated valves for switching between cycles, or alternatively, a manual pinch clamp.

[0016] Whether using bagged or batch solutions, patients are provided with the correct amount and type of dialysis solution. In CAPD therapy, after entering the treatment area, patients manually drain their effluent dialysis fluid and then manually fill their peritoneum with dialysis solution provided by the facility. In in-center APD therapy, patients proceed to a designated dialysis machine. Patients are provided with a cassette for that machine that is loaded into the machine to perform one or more automatic exchanges.

[0017] Drains at each facility may include large community or house drains. Community or house drains allow for rapid drainage to a common tank or basin for multiple patients. Structures and methods are provided to ensure sterile connection and isolation to the common drain, as well as for large dialysate storage tanks or multi-treatment fill containers, as discussed in more detail below. For example, treatment areas may provide sterilization units (e.g., UV radiation) and sterilizing agents (e.g., alcohol wipes) for sterile connections. Treatment areas may also provide meters, blood pressure cuffs, and sample collection bags and associated analyzers, all of which can be used to enhance treatment and patient care.

[0018] Alternatively, the patient may drain into a single patient drain container or bag. It is contemplated that patient effluent samples may be taken in either a community drain container situation or a single drain container situation. It is expressly contemplated that the facility will perform on-site effluent analysis if the patient desires and / or if the patient's prescription requires such analysis. The facility's house drains will comply with regulations regarding the disposal of biological waste. Similarly, the facility will be equipped to properly dispose of effluent waste containers and used disposable cassettes and sets.

[0019] Instead of discarding used dialysate, some or all of the effluent dialysate may be regenerated into usable dialysate, for example, using a sorbent system. Sorbent systems remove unwanted components (e.g., toxins, fibrous material, and metabolic waste products) from the effluent dialysate absorbed from the patient, allowing the dialysate to be reused. Sorbent systems can also add desirable components (e.g., dextrose, glucose, and / or salts) to the regenerated dialysate to reconstitute the dialysate and maintain a desired osmotic gradient for ultrafiltration removal. By using a sorbent system to purify the effluent dialysate collected by a facility, the facility can reduce the amount of unused dialysate that must be ordered and stored. For example, a single patient may use hundreds of liters of unused dialysate each month; therefore, even a small facility serving only 100 patients could reduce its unused dialysate inventory by thousands of liters per month if the facility were equipped with a sorbent system to regenerate used dialysate. The use of a sorbent system to clean the effluent dialysate collected by the facility further reduces the amount of spent fluid disposed of to the environment.

[0020] As an alternative or in addition to adsorbent regeneration, other forms of effluent cleaning may be used for regeneration, such as any one or more of electrodialysis ("ED"), electrodialysis reversal ("EDR"), electrodeionization ("EDI"), ultrafiltration, reverse osmosis filtration, ultraviolet radiation, or ozone. Ozone can be generated online by exposing oxygen to ultraviolet light. This ozone can then be drawn into the effluent stream, such as via a venture pump. Ozone tends not to be well stored under positive pressure.

[0021] Dialysis solution or dialysate can be bagged or stored in a large storage tank. Dialysis solution used at home or at work is typically bagged, and the facility of the present disclosure contemplates the use of bagged dialysate. Alternatively or additionally, dialysate can be stored in a large tank common to multiple patients. Dialysis solution is provided in a variety of different forms (e.g., with different levels of dextrose or glucose) and is configured for each individual patient per their prescription. For example, a daytime exchange uses a different dialysate than the patient's prescribed overnight dialysate. Accordingly, it is contemplated that different tanks may be provided with dialysate having different levels of glucose or dextrose.

[0022] Each vessel may have multiple outlets, each connecting to a different patient line, for example, for gravity delivery. It is contemplated that an ultraviolet ("UV") lamp be positioned around each outlet so that each new connection is sterilized before allowing fluid to flow to the patient. The UV lamp may be in the form of a clamshell that opens to allow connection and disconnection. After connection, the clamshell is closed and the connection is UV sterilized. Alternatively or additionally, the connection may be sterilized by other methods, such as by using hydrogen peroxide vapor, gamma irradiation, peracetic acid, ethylene oxide, ethanol, formalin, glutaraldehyde, low-energy electron beam, and / or any other sterilization method known in the art. For safety, some of these sterilization methods may be performed in a room separate from the patient.

[0023] Various embodiments herein are targeted at countries that do not have medical reimbursement and where patients requiring dialysis treatment cannot afford the treatment. One of the main goals here is to reduce the amount of disposable waste, and therefore the cost of disposables, as drastically as possible. One reasonable way to reduce the amount of disposable waste is to regenerate and reuse components that come into contact with unused and spent dialysis fluid. Thus, in several embodiments discussed below, a reusable drain container is provided. The reusable drain container is portable. The patient receives a dry, disinfected drain container upon entering the facility and returns the drain container filled with effluent fluid after performing a remote exchange.

[0024] In one implementation, the reusable drain container is combined with a filled, sterilized, and heated filling container and a reusable CAPD set. The patient receives all three reusable units after entering the facility, carries them to the patient station, performs the remote PD exchange, and takes the used units for regeneration and returns them to the facility's front desk. If a deposit is required to receive the units, the patient may receive the deposit upon return of the units.

[0025] Each of the three units is then regenerated. In one embodiment, some or all of the drain container, fill container, and CAPD set are sent to an external location (e.g., a central location) for disinfection, sterilization, and reloading of the fill container with sterilized dialysate. Alternatively, the drain container may be disinfected at the treatment facility. However, this first implementation contemplates that the equipment used to prepare and sterilize dialysate and fluids be located at an external location and that the facility maintain minimal equipment. For example, the facility may only need a filled, reusable fill container, and perhaps a hot water disinfection bath to disinfect the reusable drain container and a larger warmer to warm the unit, if merely disinfecting (rather than sterilizing) the drain container is acceptable. The majority of regeneration is performed at an external location, with used units being transported from the treatment facility and regenerated units being transported to the treatment facility each day.

[0026]

[0026] It is also contemplated to provide a pouch for holding a CAPD set. The pouch releasably snaps onto a reusable drain container for transport. The CAPD set may be configured with three tubing legs, one leading to the patient, a second leading to a fill container, and a third leading to a drain container. The three legs converge at a junction. A manual flow control device is provided at the junction to allow the patient to switch from the drain phase or sequence to the flush phase or sequence (for priming) and then the patient fill phase or sequence. Alternatively, the CAPD set may be configured with a single line. Here, the patient first connects this single line to the patient and the drain container and performs a patient drain. The patient then disconnects the line from the drain container and reconnects the same end of the line to the fill container. The patient then performs a patient fill, which may require priming the patient line by first venting air through a hydrophobic vent provided in the single-line CAPD set.

[0027]

[0027] Single-line CAPD sets may be easier to disinfect and sterilize than tripod CAPD sets. The drain line, in particular, can become filled with fibrin and other patient particulate matter. Single-line CAPD sets may allow for easier flushing of such particulate matter. Furthermore, reconnecting a single-line APD set to the patient for filling may push some of the particulate matter back into the patient before the patient fill is complete, thereby obviating the need for removal of these particles after a remote exchange is complete. However, it is contemplated that tripod APD sets may also be capable of adequately clearing patient particulate matter and subsequently disinfecting them.

[0028] In another implementation, the reusable drain container is coupled to a permanent or semi-permanent filling system. That is, each CAPD patient station in a treatment facility is provided with a filling system that is fixed in place and does not need to be transported in or out of the treatment facility's front desk. The filling system includes an actuation unit and a filling container. The filling container is placed inside the actuation unit and remains there until removal is required for cleaning, replacement, or some other infrequent purpose. The actuation unit is open along at least one side to allow the filling container to be easily removed from the unit. The actuation unit includes a control unit that controls multiple valves and records readings from multiple sensors. The valves and sensors are connected to the actuation unit via electrical wiring, allowing them to be moved and releasably coupled to the filling container during normal use and to be detached from the filling container when the container needs to be removed from the actuation unit for any reason. The valves pinch and unpin tubing to and from the filling container to perform container filling and container emptying. The sensors provide the necessary feedback to the control unit, such as liquid temperature and conductivity feedback.

[0029]

[0029] In one embodiment, the actuation unit includes a meter that records how much fluid is delivered to the filling container and how much dialysate is dispensed from the filling container. The actuation unit includes other actuators depending on what is needed. For example, if the fluid provided to the filling container is not sufficiently sterile, the actuation unit is equipped with multiple ultraviolet ("UV") lights that irradiate the fluid to perform any remaining sterilization required. If the fluid provided to the filling container is not heated to body temperature, the actuation unit is provided with one or more heating coils that heat the fluid to the correct temperature. If the fluid provided to the filling container is purified water rather than dialysate, the filling container is provided with a removable cap to receive a dialysis additive (e.g., a granulated or powdered additive). A conductivity sensor in the actuation unit sends a signal to its control unit to confirm that the additive has been mixed with the correct volume of water. The additive can be provided in a split-open packet.

[0030] A separate sterilization unit can be provided in addition to a permanent or semi-permanent filling system. The sterilization unit is used to provide any additional sterilization required for the CAPD set at the point and time of use. Either a three-legged or single-line CAPD set can be used with the filling system and sterilization unit. The sterilization unit, on the other hand, can be used with any of the embodiments described herein that require sterilization of the PD set.

[0031] In one embodiment, the sterilization unit includes a clamshell or hinged configuration with a base and a lid. The base and lid each contain a UV light that irradiates and sterilizes the CAPD set. The patient places the CAPD set into the base, closes the lid, and presses a switch or button to initiate sterilization. In one embodiment, UV irradiation occurs for a known, preset amount of time that sterilizes the CAPD set even in a worst-case scenario, and then automatically shuts off. The patient can immediately remove the CAPD set for use. Combining the sterilization unit's irradiation with disinfection between changes (e.g., via a hot water bath) eliminates the need to package the CAPD set in a sterile bag, reducing disposable waste. CAPD sets are reused, further reducing disposable waste.

[0032] The filling system, reusable filling container, reusable drain container, and sterilization unit allow the treatment facility to be self-contained, i.e., eliminate the need for transport to and from a reclaim center. In one embodiment, the treatment facility need only have one or more preparation room water purification units, a preparation room hot water bath disinfection system or unit, and possibly a preparation room preheater for use in conjunction with the local patient station filling system and sterilization unit. In one embodiment, the only waste generated are the packets used to hold the granulated or powdered dialysis additives.

[0033] The systems and methods of the present invention allow patients to alternate between home treatment and treatment at one or more peritoneal dialysis centers. The home treatment can be PD treatment or blood treatment such as hemodialysis ("HD"). It has been suggested that combining HD and PD regimens can be beneficial. PD centers can also be more convenient for HD patients who are traveling for work or business.

[0034] One or more server computers can be connected to the patient's home device and various facilities through a web portal to store data related to the patient's home and in-facility treatment in an electronic medical record database. The database can be accessed each time the patient requires treatment to verify the patient's prescription parameters and / or to confirm or authorize the patient to receive treatment at the facility. Thus, the patient does not need to carry computer-readable media. Instead, the patient can be recorded and located on the system. The system also allows the patient's physician to access and change the patient's treatment. Both the patient's home device and the various facilities can instantly receive updated information and adjust the patient's treatment accordingly.

[0035] It should be understood, however, that the system need not be server-based. Alternatively, the facility could use a computer to accept and verify patient prescriptions, for example via a flash drive or computer stick, and identify the patient's prescribed solution type and volume. This alternative facility could be used in developing countries and other regions where a server-based system or website is not feasible. In developing countries, some or all of the peristaltic procedures could be performed at the facility.

[0036] The present system and method allows patients to conveniently receive peritoneal dialysis treatment without having to return home throughout the day. The present system and method can free patients from having to store large amounts of dialysis solution at home, assuming, for example, that the patient performs all or most of their peritoneal dialysis exchanges at one of the treatment facilities disclosed herein. With several treatment facilities located throughout the patient's town or city, patients are likely to find convenient access to peritoneal dialysis treatment regardless of what they have to do on a given day.

[0037]

[0037] It is therefore an advantage of the present disclosure to provide a system and method for performing a remote peritoneal dialysis exchange.

[0038] It is another advantage of the present disclosure that it provides a system and method for conveniently providing peritoneal dialysis exchanges.

[0039] It is yet another advantage of the present disclosure to provide a system and method for performing peritoneal dialysis exchanges in combination with home peritoneal dialysis therapy.

[0040] It is yet another advantage of the present disclosure that it provides a system and method for transmitting treatment data from a remote peritoneal dialysis exchange facility to a patient's clinic or hospital.

[0041] It is yet another advantage of the present disclosure that it provides a system and method for providing remote peritoneal dialysis exchange in which there are multiple treatment delivery methods to choose from.

[0042] It is yet another advantage of the present disclosure to provide a system and method for providing remote peritoneal dialysis exchanges in a manner that reduces disposable waste.

[0043] It is yet another advantage of the present disclosure that it provides a system and method for performing remote peritoneal dialysis exchanges in a safe and sterile manner.

[0044] It is yet another advantage of the present disclosure to provide a system and method for providing a remote peritoneal dialysis exchange with online dialysis fluid reuse and / or dialysis fluid production.

[0045]

[0045] It is yet another advantage of the present disclosure to provide a peritoneal dialysis system and method that results in very little disposable waste or cost.

[0046] It is yet another advantage of the present disclosure to provide a peritoneal dialysis filling and sterilization unit that sterilizes the treatment fluid and treatment set at the point and time of use.

[0047] It is yet another advantage of the present disclosure to provide a reusable fill container, drain container and CAPD set that can be reconditioned for reuse.

[0048]

[0048] Additional features and advantages are described herein, and will be apparent from, the following detailed description and drawings. [Brief explanation of the drawings]

[0049] [Figure 1] FIG. 1 is a perspective view of one embodiment for deploying a peritoneal dialysis exchange facility of the present disclosure. [Figure 2] FIG. 10 is a perspective view of another embodiment for deploying a peritoneal dialysis exchange facility of the present disclosure. [Figure 3] FIG. 1 is a perspective view of one embodiment for initiating a treatment session after a patient enters a peritoneal dialysis exchange facility of the present disclosure. [Figure 4] FIG. 1 is a perspective view of one embodiment for constructing a batch treatment area of ​​an exchange facility of the present disclosure. [Figure 5] FIG. 1 is a perspective view of one embodiment for constructing a batch or continuous ambulatory peritoneal dialysis ("CAPD") treatment area of ​​an exchange facility of the present disclosure. [Figure 6A] FIG. 1 is a perspective view of one embodiment for constructing a reusable supply and drain container system for a CAPD treatment area of ​​an exchange facility of the present disclosure. [Figure 6B] 6B is a plan view of one embodiment of a CAPD set that can be used with the reusable supply and drain container system of FIG. 6A. [Figure 6C] FIG. 6B is a perspective view showing the system of FIG. 6A in use in one embodiment of a CAPD treatment area of ​​an exchange facility of the present disclosure. [Figure 6D]FIG. 6B is a schematic diagram illustrating an embodiment of cleaning and regeneration for the reusable supply and drain container system and CAPD set of FIGS. 6A and 6B using a hub-and-spoke facility configuration. [Figure 7A] 6B is a perspective view of an embodiment of a CAPD treatment area of ​​an exchange facility of the present disclosure performing a patient drain procedure using the reusable supply and drain container system of FIG. 6A with an alternative bidirectional CAPD set. [Figure 7B] FIG. 6B is a perspective view of one embodiment of a CAPD treatment area of ​​an exchange facility of the present disclosure performing a patient filling procedure using the reusable supply and drain container system of FIG. 6A with an alternative bidirectional CAPD set. [Figure 8A] FIG. 1 is a perspective view of a CAPD treatment area of ​​an exchange facility of the present disclosure using one embodiment of a permanent or semi-permanent filling system. [Figure 8B] FIG. 8B is a perspective view of one embodiment of a permanent or semi-permanent filling system that can be used in the system of FIG. 8A. [Figure 8C] FIG. 8C is a perspective view of one embodiment of a filling container that can be used with the permanent or semi-permanent filling system of FIGS. 8A and 8B. [Figure 8D] FIG. 8C is a perspective view of one embodiment of an actuation unit that can be used with the permanent or semi-permanent filling system of FIGS. 8A and 8B. [Figure 8E] FIG. 8C is a top plan view of one embodiment of an actuation unit usable with the permanent or semi-permanent fill system of FIGS. 8A and 8B. [Figure 8F] FIG. 8C is a perspective view of one embodiment of a sterilization unit that can be used with the permanent or semi-permanent filling system of FIGS. 8A and 8B as well as any of the other system embodiments discussed herein. [Figure 8G] FIG. 1 is a perspective view of one embodiment of a packet containing a dialysis additive that, when mixed with a defined volume of water, produces a chemically balanced dialysate. [Figure 9] FIG. 1 is a perspective view of one embodiment for constructing an automated peritoneal dialysis ("APD") treatment area of ​​an exchange facility of the present disclosure. [Figure 10] FIG. 1 is a plan view of one embodiment of a peritoneal dialysis exchange facility according to the present disclosure. [Figure 11] FIG. 1 is a perspective view of one embodiment of a batch peritoneal dialysis treatment area of ​​a peritoneal dialysis exchange facility according to the present disclosure. [Figure 12] 1 is a plan view of one embodiment of an automated peritoneal dialysis ("APD") machine treatment area of ​​a peritoneal dialysis exchange facility according to the present disclosure. FIG. [Figure 13] 1 is a plan view of one embodiment of a continuous ambulatory peritoneal dialysis ("CAPD") machine treatment area of ​​a peritoneal dialysis exchange facility according to the present disclosure. FIG. [Figure 14] FIG. 1 is a block diagram of one embodiment of a system according to the present disclosure. [Figure 15] FIG. 10 is a block schematic diagram of another embodiment of a system according to the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0050] Treatment facility placement

[0074] Referring now to the drawings, and particularly to FIG. 1 , one embodiment for locating a treatment facility 100 of the present disclosure is shown. The treatment facility 100 is contemplated to be located along a busy street 12 in a large city with a high volume of pedestrian traffic 14, including one or more dialysis patients 16. The patients 16 may be limited to peritoneal dialysis ("PD") patients. However, with the consent of a physician or clinician, it is contemplated that one or more PD exchanges may be performed at the facility 100 for patients who would typically undergo hemodialysis ("HD"), hemofiltration ("HF"), or hemodiafiltration ("HDF"). For example, a patient 16 who is visiting for work or vacation may have their PD treatment performed at the facility 100 in lieu of the patient's usual treatment, if it is more convenient to do so.

[0051]

[0075] Street 12, in the illustrated embodiment, is a high-traffic street with busy sidewalks, thereby providing high visibility for facility 100. In FIG. 1 , treatment facility 100 is a single business located within building 20, bordering buildings 22 and 24. Facility 100 could alternatively be one of many businesses housed within a larger building or high-rise, such as buildings 22 or 24. Street 12 could be a high-traffic urban street, or a suburban street or road, such as a mall, strip mall, business park, or another high-visibility location. Facility 100 could be located at or near a hospital, medical center, or doctor's office, if desired. Facility 100 could be clearly labeled, as shown in FIG. 1 , or generically labeled with individual entrances and exits.

[0052]

[0076] As will be further discussed in connection with Figure 10, facility 100 includes a door 102 through which a patient 16 enters and exits. Door 102 may be located on the exterior of facility 100 as shown, or may be located inside the building, around hallways, and on any floor of a building, such as in a building filled with doctor's offices. Door 102 may be freely opened by any pedestrian 14 or patient 16, or, if desired, door 102 may be locked and equipped with an automatic opener that is opened by the patient 16 sliding a card, or may be opened electronically by someone working inside facility 100 upon the patient 16's arrival or when the patient 16 rings the doorbell.

[0053]

[0077] 2, facility 100 may alternatively be located within a building near a train station or landing area. It is expressly contemplated that facility 100 of the present disclosure may be located at a high-transit location such as a train station, bus station, airport, or the like, so that a patient arriving or departing from the location may perform one or more dialysis exchanges upon arrival at the location (e.g., before traveling to work) or prior to departure by train, bus, or plane, or the like (e.g., after work or before a long journey).

[0054]

[0078] Some countries have temporary stays or lodging facilities that workers use during the week before returning home for the weekend. It is expressly contemplated that facility 100 be located in such locations, or in hostels, hotels, nursing homes, or apartment complexes. It is further expressly contemplated that PD exchange facility 100 be located in a central location within a workplace, such as a large factory, or industrial park, so that workers can perform one or more dialysis exchanges (e.g., daytime exchanges) over the course of an hour or so, either before, during, or after work.

[0055] Treatment facility configuration

[0079] Referring now to FIG. 3 and as shown in conjunction with FIG. 10, after a patient 16 enters the facility through door 102, the patient, in one embodiment, proceeds to a desk 104 and can speak with a facility professional 18 staffed by a computer 106a or 106b, a smart tablet 106c, or some combination thereof. The interaction between the patient 16 and the facility professional 18 is described in more detail below in conjunction with FIGs. 10, 14, and 15, but generally involves the facility professional 18 verifying the patient 16 and confirming that the patient is authorized (e.g., prescribed) to receive treatment at the facility 100 (and, if authorized, identifying the type of treatment and treatment parameters). In the illustrated embodiment, the patient 16 provides the facility professional 18 with a smart card, memory stick, flash drive, or the like 26, which the facility professional 18 inserts into or is otherwise electronically connected to the computer 106a, 106b, tablet 106c, or some combination thereof. It is further contemplated that the patient 16 may present a barcode or other indicia using the patient's smartphone or tablet for visual inspection by facility staff member 18 at desk 104. Other structures and features for authentication and / or verification of the patient 16 are discussed below.

[0056]

[0080] Referring now to Figure 4, a large batch tank CAPD system is shown in which a patient 16 is authorized or verified at a desk 104 before being admitted into the treatment area of ​​a facility 100. Figure 4 illustrates one embodiment in which a patient 16 receives dialysis fluid from a large dialysis batch solution tank 210. Treatments involving the large dialysis batch solution tank 210 will be discussed in more detail below in connection with Figures 10 and 11. At this point, it is important to understand that a single large dialysis solution tank 210 can be used to perform simultaneous exchanges for multiple patients 16.

[0057]

[0081] In the illustrated embodiment, a large dialysis solution tank 210 is used as a hub from which multiple walls 32a-32d extend to form multiple individual and semi-private patient stations 30a-30d. The number of walls and patient stations formed for a given hub tank 210 may be greater than or less than four. Multiple hub tanks 210, each with a separating wall and corresponding patient station, may be located behind the desk area 104 of a given facility 100. Although not shown, the patient stations 30a-30d may be enclosed, for example, by curtains, walls, and / or doors.

[0058]

[0082] In the illustrated embodiment, each patient station 30a-30d includes a chair, sofa, bed, etc. 34 to allow the patient to rest comfortably during one or more PD exchanges. A television or computer monitor 36 may be mounted on the wall opposite the wall against which the chair, sofa, or bed 34 is positioned to provide entertainment and / or information to the patient 16 during one or more PD exchanges. The television 36 may be set on and / or stored within a desk or table 40, all of which are controlled via a remote control 38 provided with each patient station 30a-30d in the illustrated embodiment. One or more wall outlets 42 may be provided with each patient station 30a-30d to power the patient's personal computer, smartphone, tablet, computer / tablet combination, compact disc player, digital music player, portable television, etc.

[0059]

[0083] In the illustrated embodiment, each patient 16 at one of patient stations 30a-30d receives PD therapy fluid from a large dialysate solution tank 210 via a patient line 50. Figures 10 and 11 discuss in detail how PD therapy fluid can be metered through distributors 220a, 220b, etc., which serve as or replace patient line 50 of Figure 4. Figures 10 and 11 also discuss various ways in which patients 16 receiving treatment via the large dialysate solution tank 210 can have effluent dialysate drained before their first PD exchange or between PD exchanges.

[0060]

[0084] Referring now to FIG. 5, one embodiment of bagged CAPD is shown. After patient 16 is authenticated or verified at desk 104, patient 16 is permitted to proceed to alternative treatment facility 100, where PD treatment fluid is first delivered to patient bag 52 and then from patient bag 52 through patient line 50 to patient 16. In FIG. 5, alternative patient stations 60a-60c (any number of stations may be provided) separated by walls 62a-62d are arranged horizontally rather than in the circular layout shown in FIG. 5. Any of the horizontal, circular, or other patient station geometries discussed herein can be used with any type of PD fluid delivery mechanism discussed herein (e.g., bagged, batch, or on-line) and / or any type of effluent PD fluid drain mechanism discussed herein (e.g., bagged or community drain).

[0061]

[0085] The horizontally arranged patient stations 60a-60c may include any one, more, or all of the chair, sofa, bed, etc. 34, television 36, remote control 38, desk or table 40, and / or wall AC outlet 42 discussed above in connection with Figure 4. The stations 60a-60c may also be enclosed by curtains, walls, and / or doors.

[0062]

[0086] 5 , each patient 16 drains into their own drain bag 54, for example, to begin the first PD solution exchange performed at facility 100 or between multiple patient fills. As discussed herein, patient drains may be to an individual bag, such as bag 54, or to a common drain. Patient bags 52 are disposed on warmer 55, and may further include a meter 56 for metering any one or more or all of the unused PD fluid delivered to patient 16, the depleted PD fluid removed from patient 16, and the additional ultrafiltrate ("UF") fluid removed from the patient. UF can be measured, for example, by subtracting the total weight of unused fluid delivered to patient 16 from the total weight of depleted fluid removed from patient 16.

[0063]

[0087] Figure 5 introduces another feature of the present disclosure, discussed in more detail below, namely, that the facility 100 can provide different types of dialysate for different patients 16 or at different times during a particular treatment. For example, in Figure 4, different large dialysis solution tanks 210 can hold dialysate with different levels of dextrose or glucose. Similarly, in Figure 5, patient stations 60a and 60b are dedicated to patients receiving DIANEAL™ PD solution, while patient station 60c is dedicated to patients receiving EXTRANEAL™ PD solution. Both DIANEAL™ PD solution and EXTRANEAL™ PD solution are commercially available from the assignee of the present disclosure.

[0064]

[0088] 5 shows that a manifold line 64 runs from a source of Dianeal™ PD solution, such as a large dialysis solution tank 210, at the rear of patient stations 60a-60d to a solution line 68 located inside patient stations 60a and 60b. A second manifold line 66 runs from a source of Extraneal™ solution, such as a large dialysis solution tank 210, at the rear of patient stations 60a-60c to a solution line 68 located inside patient station 60c. When patient 16 first arrives at one of patient stations 60a-60c, patient 16 or facility staff 18 (FIG. 3) can connect solution line 68 to a fill port 72 of patient bag 52 using a valved connector 70. After bag 52 is filled, valved connector 70 is disconnected from fill port 72 of patient bag 52. The patient 16 can then fill himself or herself from the bag 52 whenever he or she is ready, for example, by using a valve on the patient transfer set, a valve on the patient end of the patient line 50, and / or by opening one or more pinch clamps (not shown) located on the patient line 50.

[0065]

[0089] It should be noted that patient line 50, patient bag 52, and drain bag 54 form a structure similar to continuous ambulatory peritoneal dialysis ("CAPD") disposable set 412, discussed below in connection with Figures 10 and 13. Indeed, CAPD can be performed using set 412 at patient stations 60a-60c of Figure 5, instead of the illustrated batch dialysis using manifold lines 64 and 66.

[0066]

[0090] To the extent that the valved connector 70 can be repeatedly and sterilely connected to the fill port 72 of the patient bag 52, the patient bag can be used multiple times during a patient 16 visit. The patient 16 may therefore fill multiple drain bags 54. In one embodiment, the patient 16 or facility staff member 18 (FIG. 3) removes the patient bag 52 from the scale 56 at the end of the patient exchange and places one or more drain bags 54, either sequentially or in pairs, on the scale 56 to record the patient's total drained weight. The patient's total fill weight is recorded before removing the patient bag 52. The patient's in-session UF can therefore be calculated by subtracting the total fill weight from the total drained weight. Various methods for recording and monitoring patient data generated at the facility 100 are discussed below.

[0067]

[0091] Referring now to FIG. 6A, a CAPD embodiment using a CAPD unit 140 that eliminates disposables is shown. In certain countries, patients are not reimbursed for dialysis treatment. In these cases, keeping costs low is especially important. One way to achieve this is to reduce or eliminate disposable waste. Reusing and resterilizing components reduces material costs and any costs associated with disposing of potential biohazards. The CAPD unit 140 is shown in an assembled configuration for easy transport. The CAPD unit 140 includes a reusable fill container 142 and a reusable drain container 160. The reusable fill container 142 and the reusable drain container 160 can be made from the same or different materials, and in one embodiment are made from semi-rigid or rigid plastic.

[0068]

[0092] In one embodiment, the fill container 142 and the drain container 160 are plastic, such as polypropylene ("PP"), high-density polyethylene ("HDPE"), low-density polyethylene ("LDPE"), polycarbonate ("PC"), glycol-modified polyethylene terephthalate ("PET-G"), polyvinyl chloride ("PVC"), and combinations thereof. The fill container can alternatively or additionally be stainless steel, such as 316 stainless steel. The drain container 160a can alternatively or additionally be stainless steel or aluminum. The containers 142 and 160 have wall thicknesses that, in various embodiments, are generally uniform and can be about 1 mm to about 7 mm (e.g., about 4 mm). The containers 142 and 160 define internal volumes sized for a single exchange operation and, in one embodiment, can be configured to hold, for example, about 1 to about 3 liters of unused PD dialysate or patient effluent fluid.

[0069]

[0093] The reusable filling container 142, in one embodiment, is fabricated from a material that is resterilizable via a suitable process, such as ultraviolet ("UV") energy, hydrogen peroxide vapor, gamma irradiation, peracetic acid, ethylene oxide, ethanol, formalin, glutaraldehyde, low-energy electron beam, and / or any combination thereof. The reusable drain container 160 may be similarly sterilizable, although the reusable drain container 160 may simply require disinfection rather than sterilization, for example, via hot water or steam disinfection.

[0070]

[0094] The reusable filling container 142, in the illustrated embodiment, includes a top wall 144, a bottom wall (not visible), side walls 146, a front wall 148, and a back wall (not visible). For portability, the reusable filling container 142 is placed on its side, as shown in FIG. 6A. The reusable filling container 142 can have a generally rectangular, six-sided shape as shown, or it can have circular sides, oval sides, and more than six sides or surfaces. The front wall 148 carries a label 151, which can be a separate label or permanently molded into the front wall. The label 151 includes information such as the solution type (e.g., brand name), solution volume, and solution composition (e.g., dextrose level, glucose level, bicarbonate and / or electrolyte levels).

[0071]

[0095] Front wall 148 also includes a filling spout 152 having a manual on / off valve 154 and equipped with a cap 156a. Cap 156a can be a threaded cap, such as a luer cap, that screws onto the threaded end of spout 152. Cap 156a does not necessarily seal the entire weight of the PD solution, as valve 154 in the closed state prevents the PD solution from flowing out of reusable filling container 142. However, cap 156a prevents a free-flow situation if valve 154 is inadvertently opened. Cap 156a also maintains the sterility of the threaded end of spout 152.

[0072]

[0096] The filling spout 152 may also include a one-way check valve (not shown), such as a duckbill-type check valve, to prevent any remaining PD solution from returning to the reusable filling container 142. The check valve may have a low cracking pressure, such as 0.5 psig or less. Although not shown in FIG. 6A , the reusable filling container 142 may include a drain port, e.g., on its back or top wall or surface, that can be selectively opened to allow any remaining PD solution to be more properly poured out of the container and / or to allow sterilizing fluids or substances to be flushed through the filling container 142. Alternatively, as shown, the top wall 144 may include a hydrophobic vent 145. The vent 145 aids in the filling of the reusable filling container 142 with, for example, a sterilizing agent or unused PD solution, for example. The vent 145 also aids in the smooth gravity-feed of unused PD solution by the reusable filling container 142 to the patient 16 while allowing air to clear the filling container 142 and expel the gravity-fed fluid.

[0073]

[0097] The side wall 146 includes or is provided with a handle 158, which can be a hinged handle that can be lifted from the side wall 146 when desired, allowing a user (e.g., a patient or facility staff member) to lift the entire unit 140, for example, to a room or cubicle for use. In the illustrated embodiment, the reusable filling container 142 is filled with PD solution and placed on its side in combination with the drain container 160. Other combinations of filling and drain container configurations are possible, although the illustrated combination is advantageous because it distributes the fluid weight evenly throughout the footprint of the CAPD unit 140. Assuming the reusable filling container 142 is adequately filled with fluid during transport, the fluid should not slosh around excessively. Alternatively, the handle 158 can be located on the top surface 144 of the reusable filling container 142 or on the top surface of the drain container 160 so that the CAPD unit 140 hangs more vertically during transport.

[0074]

[0098] The reusable drain receptacle 160, in the illustrated embodiment, includes a top wall 162, a bottom wall (not visible), side walls (not visible), a front wall 164, and a back wall (not visible). For transport, as shown in Figure 6A, the reusable drain receptacle 160 is also placed on its side. The reusable drain receptacle 160 can have a generally rectangular, six-sided shape as shown, or it can have circular sides, oval sides, and more than six sides or surfaces.

[0075]

[0099] The top wall 162 includes a drain fluid inlet 168 equipped with a cap 170a. The cap 170a may also be a threaded cap, such as a luer cap, that screws onto the threaded end of the drain fluid inlet 168. The cap 170a maintains the threaded end of the drain inlet 168 in a disinfected or sterile state. The top wall 162 and the bottom wall (not visible) of the drain receptacle 160 each include (e.g., are molded with) or are provided with a mounting peg 166 that removably receives the end of an expandable strap 176 that a user (e.g., a patient or facility personnel) utilizes to hold the CAPD unit 140 together or to separate and remove the fill receptacle 142 and drain receptacle 160. The expandable strap 176 may be made of a stretchable nylon or bungee cord material. The strap 176, in the illustrated embodiment, is thin so that it can easily fit under the handle 158 of the reusable filling container 142. The strap 176 compresses to form-fit the reusable drain container 160 when the filling container 142 is removed, so that the strap remains connected to the drain container 160 and is not lost from the drain container 160 during storage.

[0076]

[0100] The top wall 162 is similar to the top wall 144 of the reusable filling container 142 and may include a hydrophobic vent 167. The vent 167 facilitates filling the reusable drain container 160 with, for example, a disinfectant or sterilant agent or spent effluent from a patient. The vent 167 facilitates smooth gravity feeding of the effluent solution into the reusable drain container 160, thereby allowing air to be expelled from the container 160.

[0077]

[0101] The front wall 164 of the reusable drain container 160, in the illustrated embodiment, includes (e.g., is molded with) or is provided with four mounting pegs 174 that removably receive corners of a flexible CAPD set pouch 180. The pouch 180, in the illustrated embodiment, includes an inner chamber sealed at edges 184 to form outer tabs that define mounting holes for removably fitting over the mounting pegs 174 of the reusable drain container 160. In one embodiment, one of the edges 184 is configured to be opened for a treatment and then resealed after the pouch 180 and its enclosed CAPD set 190 are cleaned and resterilized for another treatment. The resealable edge 184 can be of the tongue-and-groove type or include a zipper that seals two flaps together when closed, providing a rigid, sealable, and selectably openable closure for the pouch 180. In one embodiment, all materials for pouch 180, including any zipper or tongue and groove materials, are capable of withstanding at least one of the sterilization procedures discussed herein.

[0078]

[0102] The resealable pouch 180 holds a reusable CAPD set 190, as discussed in more detail below. The pouch 180 is provided with and carried by the reusable drain container 160. When the patient 16 proceeds with the unit 140 to a designated area within the facility 100 for treatment, the patient removes the stretchable strap 176 to allow the filling container 142 to be lifted from the drain container 160. The pouch 180 is then pulled open from the drain container 160 to allow the CAPD set 190 to be removed for use. Connecting the stretchable strap 176 and resealable pouch 180 to the drain container 160 allows each filling container 142 to be stored with the other filling containers 142 in a heated environment, neatly and without additional structure. The PD solution should be heated to body temperature or approximately 37°C (98°F) before delivery to the patient. Therefore, it is contemplated to provide one or more larger heated and insulated storage areas or tanks within facility 100 (e.g., anteroom 150) that heat and maintain filling vessel 142 at the desired temperature. Constructing filling vessel 142 neatly or without additional structures also aids in the overall heating efficiency of facility 100.

[0079]

[0103] 6B, set 190 illustrates one embodiment of a CAPD set of the present disclosure. CAPD set 190 includes a patient line 192, a fill line 194, and a drain line 196. Patient line 192 is capped by removable cap 198b, which, when removed, allows connection of patient line 192 to the patient's transfer set after the patient removes cap 198a from their transfer set. Fill line 194 is capped by removable cap 156b, which, when removed, allows connection of fill line 194 to fill spout 152 of fill container 142 after the patient removes cap 156a from fill spout 152. Drain line 196 is capped by removable cap 170b, which, when removed, allows connection of drain line 196 to drain inlet 168 of drain container 160 after the patient removes cap 170a from drain inlet 168.

[0080]

[0104] 6B also shows that the drain line 196 includes a sample port 202. The sample port includes a pierceable septum 204 through which a patient can insert a syringe or needle, after disinfection with an alcohol wipe, for example, to withdraw a patient effluent sample during patient drainage. The syringe can be retained as the patient's property or provided by and returned to the treatment facility 100.

[0081]

[0105] It is contemplated that the CAPD set 190 may be modified to make it easier to clean, disinfect, and resterilize between treatments. For example, it is contemplated that one or more or all of the patient line 192, fill line 194, and drain line 196 may have a larger inner diameter, e.g., an outer diameter of 0.375 inches (9.5 millimeters), so that a mechanical brush or pipe cleaner-type device can be inserted into the line and moved back and forth to remove any fibrin or other material remaining after replacement. Alternatively or additionally, one or more or all of the inner walls of the patient line 192, fill line 194, and drain line 196 may be coated with a physiologically safe, non-friction material. Alternatively, the lines 192, 194, and 196 may be fabricated from a low-friction or slippery material or another form of material that reduces the amount of fibrin or other residual material that is trapped. Alternatively or additionally, one or more or all of the walls of the patient line 192, fill line 194, and drain line 196 can be made thicker to allow the CAPD set 190 to undergo higher pressures during cleaning with pressurized water or detergent. Further alternatively or additionally, one or more or all of the patient line 192, fill line 194, and drain line 196 can be made from or coated with a particularly chemically inert material to allow the CAPD set 190 to be exposed to more aggressive detergents or other cleaning agents, such as ozone, or any of the sterilizing agents or processes listed above. Still further alternatively or additionally, one or more or all of the patient line 192, fill line 194, and drain line 196 can be made from a high-temperature resistant material to allow the CAPD set 190 to be exposed to prolonged high temperatures or steam disinfection. The materials and tubing sizes used in the CAPD set 190 are selected to allow the CAPD set to be easily sanitized (e.g., disinfected and sterilized) and to remove any residual body proteins or other materials left within the set.

[0082]

[0106] 6B further shows that the CAPD set 190 also includes an extra, unused transfer set cap 198a. When the patient 16 completes a PD exchange using the CAPD unit 140, the user places the unused transfer set cap 198a in the patient's transfer set, keeping it clean and protected until it's time for the next exchange. The patient places the old transfer set cap 198a in the pouch 180 along with the other used caps 198b, 156a / 156b, and 170a / 170b, and used tubing for resterilization.

[0083]

[0107] 6B also illustrates that the flow control device 90 can be operated by the patient to select a desired flow path or a no-flow state as part of or in combination with the CAPD set 190. Various embodiments of the flow control device 90 are disclosed in U.S. Patent Publication No. 2009 / 0143723, entitled "Flow Control Device For Peritoneal Dialysis," filed November 29, 2007, the entire contents of which are incorporated herein by reference. For ease of illustration, the flow control device 90, as shown, includes a patient port 92, a fill port 94, a drain port 96, and a dial 98. In one embodiment, the patient line 192 forms a "Y" or "T" leading to a fill line 194 and a drain line 196. By arranging a "Y" or "T" shaped tube connector within the flow control device 90, it is possible for the patient line 192 to extend through the patient port 92, the fill line 194 to extend through the fill port 94, and the drain line 196 to extend through the drain port 96.

[0084]

[0108] In the example of Figure 6B, when the patient turns dial 98 so that the arrow extending from dial 98 does not point toward any of ports 92, 94, or 96, flow control device 90 is in a no-flow state with lines 192, 194, and 196 below device 90 all blocked. If the patient turns dial 98 counterclockwise (as indicated by the arrow in Figure 6B) so that the arrow points toward patient port 92 and drain port 96, as the patient is first instructed to do, patient line 192 and drain line 196 open, allowing the patient to drain. If the patient turns dial 98 further counterclockwise so that the arrow points toward fill port 94 and drain port 96, as the patient is second instructed to do, fill line 194 and drain line 196 open, allowing fill line 194 to be primed and flushed to expel air. If the patient rotates the dial 98 counterclockwise one more time so that the arrows point toward the patient port 92 and the fill port 94, as the patient is instructed to do third, the patient line 192 and the fill line 194 are opened, allowing the patient 16 to receive a fill with fresh PD solution. Rotating the dial 98 to an intermediate position between any of the drain, flush, or fill settings places the control device 90 in a no-flow state, allowing the patient 16 to pause between the drain, flush, and fill sequences.

[0085]

[0109] Flow control device 90, like the syringe associated with sample port 102, can be patient property or can be provided by and returned to treatment facility 100 as a replacement. In the illustrated embodiment, it is assumed that flow control device 90 does not actually come into contact with any fluid, either unused or effluent, and therefore does not require resterilization. In an alternative embodiment in which any one or more of patient line 192, fill line 194, or drain line 196 are fluidly connected to (rather than through) patient port 92, fill port 94, or drain port 96, resulting in alternative device 90 contacting fluid, flow control device 90 is supplied via pouch 180 and placed within pouch 180 for resterilization at the end of treatment. However, for clarity, it is also possible to store, supply, and transport flow control device 90 via pouch 180 even when the flow control device does not come into contact with fluid.

[0086]

[0110] Referring now to FIG. 6C, the treatment facility 100 is shown with the CAPD unit 140 operational. For ease of illustration, only a single patient station 126b is shown generally. However, just as with the embodiments of FIGS. 4 and 5, it is contemplated that the treatment facility 100 of FIG. 6B may have multiple patient stations 126a, 126b, 126c, 126n, separated by respective walls or partitions 128b, 128c, 128n. The patient stations 126a-126n may include any one, more, or all of the chair, sofa, bed, etc. 34, television 36, remote control 38, desk or table 40, and / or wall AC outlet 42 discussed above in connection with FIG. 4. The stations 126a-126c may similarly be enclosed by curtains, walls, and / or doors.

[0087]

[0111] FIG. 6C shows that the patient 16 has been provided with a CAPD unit 140 of the type shown in FIGS. 6A and 6B and has transported the unit to the designated patient station 126b. The patient 16 has removed the stretchable strap 176 to allow the reusable filling container 142 to be detached from the reusable drain container 160. The patient 16 has also reattached the stretchable strap 176 so that the reusable filling container 142 is now connected only to the reusable drain container 160. In one embodiment, a scale 56 is provided at the patient station 126b. The patient 16 first places the preheated reusable filling container 142 on the scale 56 and records (e.g., manually on paper or by entry into a smartphone or tablet) or (e.g., wirelessly from the scale 56 to one of the facility computers 106a-106f) the weight of the unused dialysate placed in the reusable filling container 142. The weight of the reusable fill container 142 is generally known and can be subtracted from the weight recorded by the scale 56, or can be assumed to be offset by the weight of the reusable drain container 160 when the entire drain container is weighed at the end of the exchange, with the difference between the discharged effluent weight and the unused dialysate fill weight being recorded (either manually or automatically as described above) as the patient's ultrafiltration ("UF") volume removed throughout the exchange.

[0088]

[0112] The patient 16 then lifts the preheated reusable filling container 142 from the scale 56 and places it on a ledge, shelf, table, or pedestal 134 that is set high (or has an adjustable height) to allow fresh, heated dialysate to flow at the appropriate gravity feed pressure (e.g., 2 psig) that is safe for the patient 16. Such a height may be, for example, approximately 2 feet (0.60 meters). The patient 16 then places the reusable drain container 160 on the scale 56 next to their chair. It should be understood that the scale 56 is not required, and that without the scale 56, the patient 16 could instead first place the reusable drain container 160 on the floor next to their chair and then place the reusable filling container 142 on the ledge, shelf, table, or pedestal 134. It should be understood that the patient stations 126a-126n and the corresponding facility 100 that utilizes them are relatively simple in construction. All that is required for the facility 100 is the front desk 104, the filling container warmer, and the patient stations 126a-126n, while all that is required for the patient stations 126a-126n are chairs, scales 56, ledges, shelves, tables or pedestals 134, and any other accessories necessary for patient comfort.

[0089]

[0113] Patient 16 then connects CAPD set 190 to themselves, to reusable fill container 142, and to reusable drain container 160. To minimize the possibility of contamination, patient 16 removes caps from lines and then connects the lines to their destinations as quickly as possible. For example, patient 16 may first remove cap 170a from drain fluid inlet 168 and cap 170b from drain line 196, then immediately connect drain line 196 to drain fluid inlet 168. Patient 16 may then remove cap 156a from fill spout 152 and cap 156b from fill line 194, then immediately connect fill line 194 to fill spout 152. Patient 16 may then remove transfer set cap 198a from their transfer set and cap 198b from patient line 192, then immediately connect patient line 192 to the patient's transfer set (not shown). The fill line 194 and drain line 196, and possibly also the patient line 192, are occluded during the above connections via manual clamps (e.g., Halkey Roberts™ clamps), via flow control device 90, or possibly by using both manual clamps and flow control device 90.

[0090]

[0114] In the illustrated example, six removed caps 156a, 156b, 170a, 170b, 198a, and 198b are placed on a shelf, shelf, table, or pedestal 134 for storage. In FIG. 6C, pouch 180 is shown to hold an extra sterile transfer set cap 198a that patient 16 will remove from the pouch to cap the patient's transfer set at the end of a PD exchange. The sterile transfer set cap 198a can be equipped with a small, enclosed disinfectant pocket prior to sterilization. When patient 16 places cap 198a on the patient's transfer set at the end of the exchange, this pocket is ruptured, spreading disinfectant onto the tip of the patient's transfer set. The disinfectant helps maintain the patient's transfer set in a sterile condition between exchanges. One suitable cap with an integrated disinfectant is shown in U.S. Pat. No. 7,198,611, entitled "Dialysis Connector And Cap Having An Integral Disinfectant," assigned to the assignee of the present disclosure, the entire contents of which are incorporated herein by reference and upon which reliance is placed.

[0091]

[0115] The patient 16 then manipulates either the manual clamp (e.g., a Halkey-Roberts™ clamp) or the flow control device 90 to perform the exchange. Again, the manual clamp (not shown) and / or flow control device 90 may be the property of the patient 16, or alternatively, may be loaned to the patient by the facility 100. If the components are the property of the facility 100, the patient 16 may return the manual clamp (not shown) and / or flow control device 90 to the front desk 104 at the end of treatment, for example, by placing it in a pouch 180 for reconditioning and repackaging as needed.

[0092]

[0116] Regardless of whether patient 16 uses a manual clamp (not shown) and / or flow control device 90 with CAPD set 190, the drain, flush, and fill routines are as described above. Patient 16 first removes the clamp and / or sets flow control device 90 such that fill line 194 is closed, while patient line 192 and drain line 196 are opened, allowing patient 16 to drain effluent into reusable drain container 160. The drain fluid pushes air out of container 160 through hydrophobic filtered vent 167, which prevents container 160 from pushing air out of CAPD set 190 anywhere within and allows for a smooth flow of drain fluid.

[0093]

[0117] In one embodiment, the patient 16 positions the "Y" or "T" tubing connector of the CAPD set 190 so that it is generally horizontal, and / or monitors the amount of drain fluid placed in the reusable drain container 160 (e.g., by looking at how full the container is or by watching the meter 56), and / or intuitively senses that the drain is nearing completion, allowing the patient to complete the drain phase of the exchange while leaving effluent (but still sterile) fluid in the patient line 192 and preventing air from entering. Because of this, PD patients typically drain most of the effluent (e.g., 80 percent) quickly and then hit a wall of effective flow where the effluent flow rate drops significantly. During the low-flow drain period, the patient 16 can move around or stand up to reposition their indwelling catheter in an attempt to drain the last portion of the effluent (e.g., 20 percent). It is during this time that the patient 16 becomes aware of the patient line 192 in order to complete the drain phase with the patient line 192 filled. However, even if the patient line 192 becomes partially or completely filled with air, (i) the patient line 192 is narrow enough to accommodate only a small amount of air, and (ii) the air does not carry contaminants because it is either from the patient or from the disinfected or sterilized reusable drain container 160. At the end of draining, the patient 16 removes the drain line 196 from the container 160 and replaces the drain cap 170a onto the drain fluid inlet 168, allowing the now-filled drain container 160 to be tilted and carried.

[0094]

[0118] At the end of the drain phase, or when the patient 16 is not initially filled with fluid, the patient 16 sets the manual clamp and / or flow control device 90 so that the patient line 192 is closed while the fill line 194 and drain line 196 are opened, allowing the patient 16 to prime and flush the fill line 194, forcing air out of the line 194 and into the reusable fill or drain container 142, 160. The patient 16 sees the fill line 194 filled with fluid. Once the fill line 194 is completely filled, the patient 16 terminates the flushing of the fill line using the manual clamp and / or flow control device 90. The drop in the unused fluid level in the reusable fill container 142 draws and clears air through the hydrophobic filtering vent 145, which allows the container 142 to purge air from the CAPD set 190, find nowhere inside, and ensure smooth fluid flow during flushing.

[0095]

[0119] At the end of the priming and flushing phases, the patient 16 sets the manual clamps and / or sets the flow control device 90 so that the patient line 192 and fill line 194 are open, while the drain line 196 is closed, allowing the patient 16 to gravity fill (at the desired high head pressure) with fresh fluid from the container 142. The drop in the fresh fluid level in the reusable fill container 142 again draws and purges air through the hydrophobic filtering vent 145, thereby purging the container 142 from the CAPD set 190, ensuring that no air is found anywhere inside, and allowing for a smooth flow of fresh PD fill fluid to the patient 16.

[0096]

[0120] After the patient fill, and therefore the PD exchange, is complete, the patient 16 may pack up and return to their day or evening. However, it is contemplated that the patient 16 may remain at the facility 100 for a predetermined dwell time and repeat the above-described procedure one or more times (in which case the patient 16 may be provided with multiple CAPD units 140 for use at the patient station 126b). The patient stations 126a-126n may be equipped with a warmer or an insulated box (not shown) for storing one or more preheated reusable fill containers 142. Alternatively, the patient 16 may return to the front desk 104 each time to remove the old CAPD unit 140 and receive a new one for a second, third, or other exchange. In such a case, the warmer or insulated box is not required at the patient stations 126a-126n.

[0097]

[0121] Before patient 16 returns to front desk 104, the patient removes sterility cap 198a from pouch 180, disconnects patient line 192 from their transfer set, and places (e.g., screws on) a new sterility cap 198a onto the transfer set. Again, sterility cap 198a can be loaded with a disinfectant to kill any microorganisms that may have arisen due to the time cap 198a was in pouch 180 or from the patient line 192 being removed from the transfer set.

[0098]

[0122] The patient 16 then retrieves the CAPD set 190 and the remaining five caps (with the drain cap 170a replaced in the drain fluid inlet 168) from the ledge, shelf, table, or base 134, and possibly the flow control device 90 and / or manual clamp, and places them into the pouch 180. The patient detaches the strap 176 from one of the mounting pegs 166 of the drain container 160, places the filling container 142 over the drain container 160, and reconnects the strap 176 to the peg 166 on the drain container. The patient 16 presses the pouch 180 onto the mounting peg 174, restoring the used CAPD set 190 to the configuration shown in FIG. 6A . The patient 16 then uses the handle 158 of the filling container 142 to return the used CAPD set 190 to the front desk 104. It is contemplated that the patient 16 will pay the deposit upon receiving the unused CAPD set 190, and that the facility 100 will only return the deposit to the patient 16 once the pouch 180 is returned with all necessary reusable items (e.g., all caps, the used CAPD set 190, possibly the flow control device 90, and / or a manual clamp).

[0099]

[0123] It should be appreciated that the above-described replacement produces no waste and eliminates disposable costs. The "reusable" costs are the cost of transporting the CAPD set 190 and fluid containers to and from the reconditioning site, the cost of the reconditioning itself, and the subsequent storage and heating costs at the treatment facility 100.

[0100]

[0124] Referring now to FIG. 6D, one operational flow system 270 for the CAPD unit 140 of FIGS. 6A-6C is shown. System 270 is implemented in a geographic area 272 (which could be, for example, a densely populated city in a country with little or no current dialysis or kidney failure treatment reimbursement). The example system 270 includes nine satellite treatment facilities 100a-100i. System 270 includes a central regeneration center 274 that can also serve as a tenth treatment facility 100j. Double-headed arrows indicate bidirectional transport between treatment facilities 100a-100i and regeneration center 274 / facility 100j.

[0101]

[0125] In one embodiment, used CAPD units 140 brought by patients 16 to the front desk 104 are drained and then transported intact to a reclaim center 274 / facility 100j for resterilization, disinfection, and refilling. The reclaim center 274 / facility 100j contains the equipment and chemicals (if necessary) needed to mechanically, chemically, and / or thermally sterilize the reusable filling container 142, the CAPD set 190, the caps 156a, 156b, 170a, 170b, 198a, and 198b, and possibly the reusable drain container 160. The transfer set cap 198a, in one embodiment, is equipped with a new disinfectant pouch. In an alternative embodiment, the reusable drain container 160 is disinfected, for example, with hot water or steam, but is not subjected to a sterilization process.

[0102]

[0126] In yet another alternative embodiment, the reusable drain container 160 is similarly sterilized, but the sterilization occurs at the satellite treatment facility 100a-100i. This reduces shipping and handling costs, but requires each satellite treatment facility 100a-100i to have a sterilization system (e.g., hot water bath or steam cleaning). Furthermore, if the pouch 180 with used caps and CAPD sets 190 is kept with the reusable drain container 160, each satellite treatment facility 100a-100i would need to have a method for sterilizing the CAPD sets 190, caps 156a, 156b, 170a, 170b, 198a, and 198b, and for reloading the sterilization pocket in the transfer set cap 198a. In such a case, it is contemplated that each patient 16 purchases several CAPD sets 190 that are coded (e.g., bar-coded, numbered, or otherwise designated for use only by that patient). This may provide an advantage in that any biofilm left inside the CAPD set 190 is tolerable because the biofilm will be the patient's own. Thus, used CAPD sets 190 and caps require only mechanical cleaning and subsequent hot water or steam disinfection before being placed in the pouch, which then undergoes a sterilization process (e.g., UV radiation) to sterilize the interior of the pouch and the exterior of the CAPD set 190. When a patient 16 enters the treatment facility 100, the patient receives one of their own sets. Having more than one set allows the patient 16 to come to the facility 100 each day and receive a regenerated set, while a second or third set is being regenerated for replacement the next day.

[0103]

[0127] In yet another alternative embodiment, if the CAPD set 190 is determined to be too difficult to clean, the set (and perhaps the cap) may be discarded after each use. The flow control device 90 and / or manual clamp may be reused. It is contemplated herein to make disposable, clean CAPD sets 190 as cost-effective as possible so that PD exchanges are as affordable as possible for patients.

[0104]

[0128] Referring now to Figures 7A and 7B, an alternative treatment facility 100 is shown that uses an alternative CAPD unit 240. Again, for ease of illustration, only a single patient station 136b is shown generally. However, just as with the embodiment of Figures 4 and 5, it is contemplated that the treatment facility 100 of Figures 7A and 7B may have multiple patient stations 136a, 136b, 136c...136n separated by respective walls or partitions 138b, 138c...138n. The patient stations 136a-136c may include any one, more, or all of the chair, sofa, bed, etc. 34, television 36, remote control 38, desk or table 40, and / or wall AC outlet 42 discussed above in connection with Figure 4. The stations 136a-136c may similarly be enclosed by curtains, walls, and / or doors.

[0105]

[0129] The CAPD unit 240 includes the reusable fill container 142 and the reusable drain container 160, including all associated structures and alternatives, as already described above. The primary difference between the alternative CAPD unit 240 and the CAPD unit 140 discussed above is that the CAPD set 190 has been replaced with a simplified CAPD set 290. The simplified CAPD set 290 includes a single line or tubing 292 capped at each end by a patient cap 294 and a drain / fill container cap 296. The line or tubing 292 can be made from any of the materials and can have any of the diameters, lengths, and wall thicknesses discussed above for the CAPD set 190. As shown in Figures 7A and 7B, the line or tubing 292 is long enough to reach both the reusable fill container 142 and the reusable drain container 160.

[0106]

[0130] Like CAPD set 190, CAPD set 290 also includes a pierceable septum 204 through which a patient can insert a syringe or needle, after disinfection with, for example, an alcohol wipe, to withdraw a patient effluent sample during patient drainage. Again, the syringe may be owned by the patient or may be provided by and returned to treatment facility 100.

[0107]

[0131] 7A shows that the patient 16 has been given a CAPD unit 240 and has carried the unit to the designated patient station 136b. The patient 16 has removed the stretchable strap 176 so that the reusable filling container 142 can be detached from the reusable drain container 160. The patient 16 has also reattached the stretchable strap 176 so that the reusable filling container 142 is now connected only to the reusable drain container 160. The patient 16 then places the preheated reusable filling container 142 on the scale 56 and records the weight of the fluid in the reusable filling container 142 (e.g., manually on paper or via entry into a smartphone or tablet) or (e.g., via a wireless signal from the scale 56 to one of the facility computers 106a-106f).

[0108]

[0132] The patient 16 then lifts the preheated reusable filling container 142 from the scale 56 and places it on the ledge, shelf, table, or pedestal 134 that is set (or has an adjustable height to be set) high enough to allow the fresh, heated dialysate to flow at the proper gravity-feed pressure that is safe for the patient 16. The patient 16 then places the reusable drain container 160 on the scale 56 next to their chair. Again, the scale 56 is not required, and without the scale 56, the patient 16 could instead first place the reusable drain container 160 on the floor next to their chair and then place the reusable filling container 142 on the ledge, shelf, table, or pedestal 134.

[0109]

[0133] 7A illustrates a drain procedure using the CAPD unit 240. Here, with both ends of the line or tubing 292 clamped via mechanical clamps (not required here for the flow control device 90), the patient 16 removes the cap 170a from the drain fluid inlet 168 and the drain / fill container cap 296 from the distal end of the line or tubing 292 and places the caps 170a and 296 on the ledge, shelf, table, or pedestal 134. The patient then connects the distal end of the line or tubing 292 to the drain fluid inlet 168 of the drain container 160. The patient 16 then removes the patient cap 198a from the patient transfer set and the patient cap 294 from the proximal end of the line or tubing 292 and places the caps 198a and 294 on the ledge, shelf, table, or pedestal 134. The patient then connects the proximal end of the line or tubing 292 to the patient transfer set. The patient is now set to drain.

[0110]

[0134] For drainage, as shown in FIG. 7A , the patient 16 removes a manual clamp (e.g., a Halkey-Roberts™ clamp) from the line or tubing 292 to allow gravity flow of effluent fluid from the patient's peritoneum to the drain container 160. The hydrophobic cap 167 on the drain container 160 allows air to vent while the effluent fluid fills the container, allowing the effluent fluid to flow smoothly from the patient's peritoneum to the drain container. Again, the patient 16 drains quickly initially, then reaches a low-flow stage. During the low-flow stage, the patient 16 can stand or use their body to assist in draining the last of the patient's effluent from the patient's peritoneum. The patient 16 can withdraw an effluent sample from the pierceable septum 204 at any point during drainage. When the patient 16 is nearing the end of the drain phase (as determined by the patient using the meter 56, the level of drain fluid in the container 160, or through acquired knowledge), the patient clamps the distal end of the line or tubing 292 and removes the distal end of the line from the drain fluid inlet 168 of the drain container 160, attempting to leave fluid in the tubing 292 so that the line remains primed. The patient 16 then replaces the drain cap 170a onto the drain fluid inlet 168, which now allows the full drain container 160 to be tilted and carried.

[0111]

[0135] 7B , to fill with fresh fluid, the patient 16 removes the cap 156a from the filling container fill spout 152 and sets the cap 156a on the shelf, shelf, table, or pedestal 134. The patient 16 moves the distal end of the line or tubing 292 from the fluid inlet 168 of the drain container 160 to the filling spout 152 of the reusable filling container 142 and connects the distal end to the filling spout 152. The patient 16 then removes the manual clamp from the distal end of the line or tubing 292 and opens the manual on / off valve 154 of the reusable filling container 142. If for any reason the line 292 does not prime or is incompletely primed, the patient 16 can close the clamp on the proximal end of the line or tubing 292 (e.g., between the patient and the pierceable septum 204). Fresh fluid from the filling container is gravity-fed into line or tubing 292, which forces air up the line into filling container 142 and out the container's hydrophobic vent 145. If desired, a hydrophobic vent (not shown) can be incorporated into the pierceable septum 204 of the reusable line or tubing 292, allowing air to be sterilely forced out the hydrophobic vent (not shown) by fresh fluid from filling container 142 that is gravity-fed into line or tubing 292. The hydrophobic vent can eliminate the need to prime line 292 after the drain phase. Once priming is complete, the manual clamp on the proximal end of line or tubing 292 can be removed.

[0112]

[0136] Fresh fluid from the fill container 142 then fills the patient's peritoneum. Once the fresh fluid fill is complete, the patient packs up the CAPD unit 240 in the same manner as discussed above for the CAPD unit 140. In particular, before the patient 16 returns to the front desk 104, the patient removes the new sterility cap 198a from the pouch 180, disconnects the line or tubing 292 from their transfer set, and places (e.g., screws on) the new sterility cap 198a onto the transfer set. As before, the sterility cap 198a can be loaded with a disinfectant to kill any microorganisms that may have arisen due to the time the cap 198a was in the pouch or from the removal of the patient line 292 from the transfer set. The patient 16 then retrieves the remaining three caps 198a, 294, and 296 (with the drain cap 170a having been replaced on the drain fluid inlet 168) from the ledge, shelf, table, or pedestal 134, and possibly a manual clamp, and places them into the pouch 180. The patient detaches the strap 176 from one of the mounting pegs 166 on the drain container 160, places the filling container 142 over the drain container 160, and reconnects the strap 176 to the peg 166 on the drain container. The patient 16 then presses the pouch 180 onto the mounting peg 174, restoring the used CAPD unit 240 to the configuration shown in FIG. 6A . The patient 16 then uses the handle 158 on the filling container 142 to return the used CAPD unit 240 to the front desk 104. Again, it is contemplated that the patient 16 will pay a deposit upon receiving the unused CAPD set 240, and that the facility 100 will only return the deposit to the patient 16 once the pouch 180 is returned with all required reusable items (e.g., all caps, used CAPD unit 240, and possibly a manual clamp).

[0113]

[0137] It should be appreciated that the above-described replacement similarly produces little or no waste, significantly reducing or eliminating disposable costs. The "reusable" costs are the cost of transporting the CAPD set 290 and container to and from the reconditioning site, the cost of the reconditioning itself, and the subsequent storage and heating costs at the treatment facility 100.

[0114]

[0138] The operational flow system 270 of FIG. 6D is equally applicable to the CAPD sets 290 and units 240 of FIGS. 7A and 7B. In one embodiment, used CAPD sets 290 and units 240 brought by patients 16 to the front desk 104 are drained and then transported intact to a reclaim center 274 / facility 100j for resterilization, disinfection, and refilling. The reclaim center 274 / facility 100j contains the equipment and chemicals (if necessary) needed to mechanically, chemically, and / or thermally sterilize the reusable filling container 142, CAPD sets 190, caps 170a, 198a, 292, and 294, and possibly the reusable drain container 160. The transfer set cap 198a, in one embodiment, is equipped with a new disinfectant pouch. In an alternative embodiment, the reusable drain container 160 is disinfected, for example, with hot water or steam, but is not subjected to a sterilization process.

[0115]

[0139] Similarly, the reusable drain container 160 can be sterilized at its satellite treatment facility 100a-100i. While this reduces shipping and handling costs, it requires each satellite treatment facility 100a-100i to have a sterilization system (e.g., a hot water bath or steam cleaning). Furthermore, if the pouch 180 with the used cap and CAPD set 290 is kept with the reusable drain container 160, each satellite treatment facility 100a-100i would need to have a method for sterilizing the CAPD set 290, caps 170a, 198a, 294, and 296, and for reloading the sterilization pocket into the transfer set cap 198a. In such a case, it is contemplated that each patient 16 purchases several coded (e.g., bar-coded, numbered, or otherwise designated for use only by that patient) CAPD sets 290. This may provide the advantages discussed above with respect to the CAPD set 190.

[0116]

[0140] In yet another alternative embodiment, if cleaning of the CAPD set 290 is determined to be excessively difficult, the set (and perhaps the cap) may be discarded after each use. Here, it is contemplated that the clean CAPD set 290 will be manufactured as cost-effectively as possible so that PD exchanges are as affordable as possible for the patient. However, it should be understood that the straight-lined CAPD set 290 makes cleaning, disinfection, and sterilization easier than the CAPD set 190 discussed above.

[0117]

[0141] Referring now to Figures 8A-8G, an alternative treatment facility 100 using an alternative filling system is shown. Again, for ease of illustration, only a single patient station 186b is shown generally. However, just as with the embodiment of Figures 4 and 5, it is contemplated that the treatment facility 100 of Figures 8A-8F may have multiple patient stations 186a, 186b, 186c...186n separated by respective walls or partitions 188b, 188c...188n. The patient stations 186a-186n may include any one, more, or all of the chair, sofa, bed, etc. 34, television 36, remote control 38, desk or table 40, and / or wall AC outlet 42 discussed above in connection with Figure 4. The stations 136a-136n may similarly be enclosed by curtains, walls, and / or doors.

[0118]

[0142] The system of Figures 8A-8G can use either CAPD set 190 or 290 discussed above (set 190 is shown here). CAPD set 190 or 290 can again be provided within CAPD set pouch 180. It is contemplated that the cap used with CAPD set 190 or 290 can be eliminated and instead pouch 180 can be provided with only a new patient transfer set cap 198a that can be equipped with a disinfectant breakable pouch as previously described above. In yet another alternative embodiment, pouch 180 is also eliminated, and instead a new transfer set cap 198a is placed on the end of patient tubing 192. If cap 198a is equipped with a disinfectant, cap 198a can be loosely threaded onto patient tubing 80 to prevent the disinfectant from escaping.

[0119]

[0143] Additionally, in one embodiment, the CAPD set 190 or 290 is not completely sterilized when administered to the patient 16. Instead, between treatments, the CAPD set 190 or 290 is subjected to hot water disinfection to mechanically flush any residual fiber and particulate matter from the set, ensuring that the set is completely free of patient material. This hot water also partially sterilizes the CAPD set 190 or 290. If desired, a mild sterilizing agent, such as an organic solvent, can be added to the hot water disinfection. In this case, hot water is used at the end of the disinfection process to flush this mild sterilizing agent from the CAPD set 190 or 290.

[0120]

[0144] Terminal sterilization of the CAPD set 190 or 290 is performed in various embodiments at the patient station 186b using a sterilization unit 340. In FIGS. 8A and 8F, the sterilization unit 340 includes a base 342 and a lid 360 hingedly connected to the base 342. The base 342 and lid 360 can be configured to rest on a table or an overhanging shelf (FIG. 8F), such as the overhanging shelf 134. In the embodiment shown in FIG. 8A, the base 342 alternatively includes its own set of legs 344 to elevate and support the base 342 and lid 360 off the floor. The interior surfaces of the base 342 and lid 360 are, in one embodiment, fabricated from or coated with an ultraviolet ("UV") light-reflective material for reasons discussed below. The patient 16 places the CAPD set 190 or 290 and transfer set cap 198a within the clamshell between the base 342 and lid 360, and the clamshell is closed. The sterilization unit 340 then activates the upper and lower arrays of UV lights or UV-LEDs for a time sufficient to properly sterilize the disinfected CAPD set 190 or 290 and transfer set cap 198a.

[0121]

[0145] A power cord 346 runs from the base 342 or lid 360 to the power receptacle 42. The power receptacle 42 powers a plurality of UV lights 348, such as UV light emitting diodes (UV-LEDs), located on both the base 342 and the lid 360. The UV lights 348 may alternatively be UV lamps. The UV lights 348 are connected in series or parallel via one or more wires or printed circuit board traces 350 (FIG. 8F). In one embodiment, it is contemplated that the interior surfaces of the base 342 and the lid 360 may be ceramic or FR-4 printed circuit boards having one or more copper traces 350 formed thereon. The UV lights 348 may be surface mounted to the trace wires 350, for example, in either series or parallel, as desired. Alternatively, the wires 350 may form a mesh to which the UV lights 348 may be hardwired, soldered, or otherwise electrically connected. As yet another alternative, the UV lights 348 are UV bulbs that screw or plug into sockets provided by the interior surfaces of the base 342 and lid 360. The UV bulbs are similarly wired together in a series or parallel relationship.

[0122]

[0146] The power cord 346 plugs into a socket 352 located in the base 342 in the illustrated embodiment. Power travels from the socket 352 to a manual on / off switch 354. It is contemplated that the switch may be placed in electrical series combination with a second mechanical switch (not shown) that closes when the lid 360 is closed to the base 342. In this manner, the lid 360 must be closed before the switch 354 for the UV lights 348 is turned on to receive power to prevent UV light energy from being emitted when the unit 340 is open, which could damage or interfere with external entities. The switch 354 may be located along any surface of the sterilization unit 340 for convenient access and activation. In the illustrated embodiment, the switch 354 is in electrical communication with electronic circuitry 356. The electronic circuitry 356 may include one or more electrical components and may perform one or more functions, such as conditioning and / or regulating incoming AC power to a desired voltage and / or type (e.g., DC).

[0123]

[0147] The electronic circuitry 356 can also include a preset timer to allow the UV light 348 to be powered for a prescribed amount of sterilization time after the patient 16 places the CAPD set 190 or 290 and transfer set cap 198a on the base 342, closes the lid 360, and presses the switch 354 (e.g., a momentary, self-resetting switch). Once the prescribed amount of time has elapsed according to the timer, power to the UV light 348 is automatically removed and a ready light and / or sound generator (not shown) is activated. The patient 16 can then remove the CAPD set 190 or 290 from the sterilization unit 340 for use. The transfer set cap 198a can remain inside the sterilization unit 340 until the PD exchange is complete and the patient 16 needs a clean transfer set cap. The total disinfecting power from the cumulative light emitted by each of the UV lights 348 in the base 342 and lid 360 is sufficient (subject to certain design factors) to sterilize the CAPD set 190 or 290 within a reasonable period of time (e.g., 2-10 minutes).

[0124]

[0148] One advantage of performing the final sterilization of the CAPD set 190 or 290 at the patient station 186b is that the patient then immediately connects the CAPD set 190 or 290 to a drain and / or fill container, eliminating the need to cap the CAPD set 190 or 290. Furthermore, the CAPD set pouch 180 may also be eliminated. Furthermore, in embodiments where the patient 16 sterilized the existing cap 198a using unit 340 during drain and fill, for example, the new transfer set cap 198a may be eliminated. In this case, the patient 16 transfers their own re-sterilized transfer set cap 198a to their transfer set upon completion of the exchange and takes only the used CAPD set 190 or 290 to the front desk 104 for a deposit refund. Later that day or overnight, the treatment facility 100 collects all used and returned CAPD sets 190 and / or 290 and possibly caps 198a and places them in a hot water sterilization bath or unit that circulates and flushes hot water through the interior of the CAPD sets 190 and / or 290, and filters the circulated water to capture particles and debris dislodged from the interior of the CAPD sets 190 and / or 290, thereby removing such particles and debris from the hot water loop. The disinfected CAPD sets 190 and / or 290 are then dried and stored for use later that day or the next day.

[0125]

[0149] It is expressly contemplated that the just-described sterilization unit 340 in combination with hot water disinfection and its use to eliminate the need for CAPD pouch 180 may be used with any of the treatment facility embodiments described herein, including the embodiments of Figures 6A-6D and 7A and 7B. With respect to Figure 6D, the elimination of the caps associated with CAPD set pouch 180 and CAPD sets 190 and 290, and even the in-facility resterilization of the CAPD sets, significantly reduces, and potentially eliminates, the amount of components that require delivery to and from remanufacturing center 274 / treatment facility 100j.

[0126]

[0150] The reusable drain container 160, including all of its associated structures and replacements, can be reused at the treatment facility 100 of FIGS. 8A-8G. Again, a cap 156a is provided with the drain container 160 and is removed as shown in FIG. 8A for connection to the CAPD set 190 or 290. It is contemplated that the reusable drain container 160 is flushed with hot water and the cap 156a is reused at the treatment facility 100, as discussed above with respect to the CAPD sets 190 and 290, thereby further eliminating components requiring delivery to and from the reconditioning center 274 / treatment facility 100j. Because the container 160 is a drain container, it does not need to be fully resterilized. However, it is contemplated that the drain container 160 may be disinfected between uses, for example, via hot water disinfection or a mild detergent such as bleach.

[0127]

[0151] 8A and 8B illustrate the replacement of the reusable filling container 142 discussed above with a permanent or semi-permanent filling system 430. The filling system generally includes a filling container 432 removably coupled to an actuation unit 460. The actuation unit 460 is maintained in place (e.g., can be bolted) to a ledge, shelf, table, or pedestal 134 and is not carried around by the patient 16. FIG. 8A illustrates the actuation unit 460 operating in conjunction with a scale 56, which in one embodiment can be separate from or part of the unit 460. The actuation unit 460 includes a pair of sterilization panels 462a / 462b, a control unit 480, a ready light 474, an electrically actuated fill valve 464, and an electrically actuated dispense valve 466 (some of the items shown).

[0128]

[0152] It is contemplated that the filling container 432 will remain in at least semi-permanent association with the actuation unit 460 (e.g., across multiple treatments for multiple patients, over multiple days, or even weeks). The filling container 432, however, can be removed for intermittent cleaning, repair, or replacement. FIGS. 8A and 8C show that the filling container 432 can include a hydrophobic vent 145, just as with the reusable filling container 142. The semi-permanent filling container 432 of FIGS. 8A and 8C receives unused, but not necessarily sterile, water or peritoneal dialysis solution via a fill line 434 and an electrically actuated fill valve 464 on the actuation unit 460. A scale 56 on the actuation unit 460 works with the control unit 480 and the electrically actuated fill valve 464 to weigh the unused fluid as it enters the semi-permanent filling container 432. When the actual weight of unused fluid reaches the patient's prescribed fill weight, control unit 480 closes fill valve 464, leaving the prescribed amount of unused fluid in fill container 432. Once control unit 480 determines that the dialysate is (i) properly sterilized, (ii) of the correct chemical composition, and (iii) at the correct temperature, control unit 480 illuminates ready light 474 and allows patient 16 to press a "GO" or "START" button on control unit 480, which opens outlet valve 464 and begins the patient's fill.

[0129]

[0153] As shown below in FIG. 8E, in one embodiment, meter 56 is combined with heater 490 for heating the virgin fluid in filling vessel 432. In an alternative embodiment, the virgin fluid is heated to the appropriate temperature before flowing through filling line 434 to filling vessel 432. Alternatively or additionally, sterilization panels 462a / 462b heat the virgin fluid present in the filling vessel, or round up the necessary heating. The semi-permanent filling vessel 432 combined with the thermal disinfection and in-house sterilization of CAPD sets 190 and 290 described above with respect to FIG. 8A eliminates the need for reclaim center 274 altogether. Treatment facilities 100a-100j can therefore be self-contained and operate independently of one another.

[0130]

[0154] 8B-8E, various embodiments of the semi-permanent filling system 430, filling receptacle 432, and actuation unit 460 are shown in more detail. As discussed above, the filling receptacle 432 can be removed from the actuation unit 460 in some cases, as shown in FIG. 8C. Typically, however, the filling receptacle 432 is installed within the actuation unit 460 and operates accordingly, as shown in FIG. 8B. To facilitate easy removal of the filling receptacle 432 from the actuation unit 460, the actuation unit 460 is generally three-sided, with sterilization panels 462a / 462b providing two sides and a front panel 470 connected to the sterilization panels 462a / 462b providing the third side. The filling receptacle 432 slides into and out of the actuation unit 460 through the open back and / or top of the unit 460. As shown, the top of the actuation unit 460 alternatively or additionally remains open to allow the filling receptacle 432 to slide into and out of the actuation unit 460 through the open top of the unit. The open top also allows for attachment of various structures to the top of the filling receptacle 432. A notch 472 in the front panel 470 allows the outlet pigtail 436 of the filling receptacle 432 to extend outside of the front panel 470 and the unit 460.

[0131]

[0155] The sterilization panels 462a / 462b and front panel 470 of the activation unit 460 may be made from a metal, such as stainless steel or aluminum. The filling container 432 may be made from any of the plastic materials discussed above, such as polypropylene ("PP"), high density polyethylene ("HDPE"), low density polyethylene ("LDPE"), polycarbonate ("PC"), glycol modified polyethylene terephthalate ("PET-G"), polyvinyl chloride ("PVC"), and combinations thereof. In a preferred embodiment, the filling container 432 is made from an ultraviolet ("UV") light transparent material.

[0132]

[0156] In the illustrated embodiment, a ready light 474 (e.g., a green light) is mounted on the front panel 470 and is powered via a wire 476 that runs to a control unit 480. The control unit 480 may be a commercially available programmable logic controller ("PLC") that accepts AC power from the power supply 42, accepts analog and / or digital inputs from various external sensors, and sends analog and / or digital outputs to external devices such as electrically actuated valves 464 and 466, sterilization panels 462a / 462b, and one or more heating elements (if provided). The control unit 480 may also power sensors used with the semi-permanent fill system 430, such as a temperature sensor 494, conductivity sensors 494 / 496, a glucose sensor, and / or one or more load cells for the meter 56.

[0133]

[0157] 8B and 8D show that control unit 480 can additionally include a touch panel keypad 482 for a user to enter values ​​into the memory of control unit 480 and / or activate commands such as "GO" or "STOP." Keypad 482 can be, for example, an electromechanical membrane switch keypad or a touch screen keypad. One or more memories within control unit 480 operate in conjunction with one or more microprocessors of unit 480 that accept user and sensor inputs, utilize algorithms to interrogate such inputs, and execute outputs to electrically actuated valves 464 and 466, sterilization panels 462a / 462b, one or more heating elements 490, and sensors 494 and 496. The one or more memories and processors also operate to programmatically display data on a display panel or device 484, such as a liquid crystal display ("LCD") panel or a light emitting diode ("LED") panel.

[0134]

[0158] Alternatively, a ready light 474 or similar indicator or marking may be displayed on the display panel 484. Alternatively or additionally, the display panel 484 may provide an indication of what percentage of the start-up (e.g., sterilization and / or warming) procedure has been performed. Alternatively or additionally, the display panel 484 may provide an indication of what percentage of the procedure has been performed filling or emptying the container 432. Alternatively or additionally, the display panel 484 may guide the patient 16 through the PD treatment setup steps, prompting the patient 16 to press "GO" when the step is complete, after which the control unit 480 will display the next treatment step to perform or begin treatment if the setup is complete.

[0135]

[0159] In one embodiment, the display panel 484 displays the numbers 0-9 that the patient 16 presses to enter parameter values ​​using the keypad 482. For example, one treatment setup step may be for the patient to enter their prescribed fill volume. The display panel 484 prompts the patient 16 to do so. The patient 16 enters a volume (e.g., in liters) using the keypad 482. The display panel 484 displays the entered volume back to the patient 16. The patient 16 then presses a confirm or "GO" button. The control unit 480 converts the patient's volume or liter entry to grams so that the output of the scale 56 can be compared to the entered weight. If the patient 16 enters a fill volume that is larger than the capacity of the container 432, the display panel 484 may display an error message and prompt the patient 16 to enter a different amount.

[0136]

[0160] Alternatively, patient 16 enters a patient identification (“ID”) code using keypad 482. Control unit 480 is connected to a network linking all computers 106a-106f-100n in facility 100 with all control units 480 located within facility 100. A storage or memory in communication with this network stores the patient's ID code along with treatment prescription information, such as fill volume and solution type. In one embodiment, after patient 16 enters their code, the network's storage or memory recalls the patient's profile and sends a confirmation prompt, such as “Please verify you are Jane Doe,” to display panel 484. The patient can confirm their identity, for example, by pressing a “GO” button, or indicate a mistaken identity, for example, by pressing a “STOP” button. If a mistaken identity occurs, the network can display a message on display panel 484 requesting the patient to re-enter their ID code and repeat the verification process. If the mistaken identity continues, facility staff specialists 18 may be called. Once the patient 16 confirms that the network has properly identified itself, the network knows the patient's profile and automatically commands the control unit 480 to fill the container 432 with the correct fill volume and prompts the patient 16 to create and / or deliver the correct type of dialysate. The use of patient ID prevents the patient 16 from entering a fill volume that differs from the patient's prescribed fill volume. The patient's ID and profile can be stored on one or more memory devices of the control unit 480 as an alternative to or in addition to that of the facility network.

[0137]

[0161] As a further alternative, patient 16 is provided with an identification (“ID”) tag in the form of a card, wristband, keychain tag, necklace tag, or other form. The tag may include a bar code, radio frequency tag (“RFID tag”), or other readable structure, energy type, or marking. Activation unit 460, in turn, is provided with a corresponding reader, such as a bar code, RFID, or other reader (not shown), in data flow communication with control unit 480. In one embodiment, patient 16 scans his or her tag with the reader. The scanned information is transmitted from control unit 480 to the network, which retrieves the patient's profile. The network, knowing the patient's profile, again automatically commands control unit 480 to fill container 432 with the appropriate fill volume and prompts patient 16 to create and / or deliver the appropriate type of dialysate. The use of a patient ID tag similarly prevents patient 16 from entering a fill volume different from the patient's prescribed fill volume and eliminates the need for the patient to memorize an ID code. The patient's ID profile may again be stored on one or more memory devices of the control unit 480 as an alternative or in addition to that of the facility network.

[0138]

[0162] Both the ID code and ID tag embodiments may also require a patient password to be entered to prevent someone fraudulently using another person's ID code or ID tag from receiving treatment.

[0139]

[0163] After the proper fill volume is confirmed by any of the techniques discussed above, control unit 480 then causes actuation unit 460 to open fill valve 464 while keeping dispense valve 466 closed. Referring to Figures 8B and 8D, in the illustrated embodiment, fill valve 464 and dispense valve 466 are spring-closed, bias-open, electrically actuated solenoid pinch valves. Valves 464 and 466 are therefore fail-safe because they automatically close when power is removed or lost, resulting in a no-flow state for semi-permanent fill system 430. Valves 464 and 466 are connected to control unit 480, and thus to actuation unit 460, by electrical cables 464a and 466a, respectively. Electrical cables 464a and 466a allow control unit 480 to selectively power valves 464 and 466. The electrical cable also provides a flexible connection of valves 464 and 466 to actuation unit 460, allowing the valves to be lifted out of filling vessel 432 for removal while still remaining attached to actuation unit 460 (FIG. 8D).

[0140]

[0164] Valves 464 and 466 each include a press bar 464b and 466b, respectively, mechanically attached to the body of the respective valve. The pigtail tube 436 and 438 of the filling container 432 is compressed between the valve plunger and the press bar 464b and 466b when power is removed from the valve. Each of the valves 464 and 466 also includes a locking pin 464c and 466c, respectively, in one embodiment, hingedly connected to the body of the valve and rotatably snapped into place on its respective press bar 464b and 466b. When snapped into place, the locking pin 464c and 466c prevent the valves 464 and 466 from disengaging from the pigtail 436, 438, even when the valve is biased and the valve plunger is pulled away from the press bar 464b and 466b. When facility technician 18 wishes to remove valves 464 and 466 from their respective tubes, for example to remove container 432 from actuation unit 460, facility technician 18 unlocks locking pins 464c and 466c, rotates the pins away from press bars 464b and 466b, respectively, biasing valves 464 and 466 so that the valve plungers no longer pinch tubes 436, 438, and pulls valves 464 and 466 away from the tubes. With valves 464 and 466 removed, container 432 is free to pull away from actuation unit 460.

[0141]

[0165] One embodiment contemplates allowing facility staff 18 to enter a service mode via control unit 480 to manually activate valves 464 and 466, for example, for valve placement and removal, valve inspection, or other reasons. Each activation unit 460 may have a service mode code that is entered via keypad 482. Once the proper code is entered, activation unit 460 enters service mode and displays several service mode options on display panel 484 to facility staff 18. One such option may be toggling or activating valves 464 and 466. Touchable buttons may be displayed on display device 484 for each valve 464 and 466. Alternatively, instructions such as "touch 1 to open fill valve" or "touch 2 to open dispense valve" may be displayed on display device 484 to enable use of keypad 482 to toggle the valves. In either case, it is contemplated that when facility professional 18 selects a display or keypad button to open one of valves 464 or 466, control unit 480 will hold the valves in the open state for a predefined period of time without further button presses from facility professional 18, thereby allowing the facility professional a free hand to either apply valves 464 and 466 to tubes 436 and 438 or remove the valves from their respective tubes.

[0142]

[0166] When the control unit 480 opens the fill valve 464 and the inlet pigtail 438 while keeping the outlet valve 466 and the outlet pigtail 436 closed, the fill container 432 begins to fill with liquid (e.g., purified or sterilized water, or purified or sterilized dialysis solution, as discussed in more detail below). As the liquid fills the fill container 432, the hydrophobic vent 145 allows displacement air to escape. Additionally, the scale 56 measures the total weight of the fluid. The scale or load cell 56 is shown in FIGS. 8A, 8B, 8D, and 8E. The top view of the actuation unit 460 in FIG. 8E shows that the scale 56 can include a single sensor (e.g., a load cell or strain gauge). Alternatively, the scale 56 can include multiple sensors whose outputs are combined to produce a single, accurate weight reading.

[0143]

[0167] As mentioned above, the reading from the scale 56 is received by the control unit 480 and compared to the commanded fill volume or weight. When the actual volume or weight of liquid inside the fill container 432 reaches the commanded volume or weight, the control unit 480 closes the fill valve 464 and the inlet pigtail 438. During the fill, the display device 484 is contemplated to indicate to the patient 16 how much fill has been completed, along with how much more fill remains to be completed. A dynamic fill indication can be shown by an ever-increasing instantaneous percentage, by characters or shapes with increasing fill color, and / or by an ever-increasing actual instantaneous volume or weight value for the current fill. The fill indication allows the patient to see how much more fill time remains. It is contemplated that the patient 16 may perform any necessary drainage while the fill container 432 is being filled. The patient 16 drains into a reusable drain container 160 according to any of the methods and alternatives and using any of the structures discussed above.

[0144]

[0168] The next step after filling is complete depends on the type and state of the fluid delivered to the filling vessel 432. The present disclosure contemplates at least eight scenarios: (i) the filling vessel 432 is filled with unheated purified dialysate, (ii) the filling vessel 432 is filled with heated purified dialysate, (iii) the filling vessel 432 is filled with unheated sterilized dialysate, (iv) the filling vessel 432 is filled with heated sterilized dialysate, (v) the filling vessel 432 is filled with unheated purified water, (vi) the filling vessel 432 is filled with heated purified water, (vii) the filling vessel 432 is filled with unheated sterilized water, and (viii) the filling vessel 432 is filled with heated sterilized water.

[0145]

[0169] Only in scenario (iv), where filling vessel 432 is already filled with heated, sterilized dialysate, can control unit 480 open dispense valve 466 and outlet pigtail 436 while keeping fill valve 464 and inlet pigtail 438 closed, and proceed to empty filling vessel 432 and fill patient 16. Each of the other scenarios (i)-(iii) and (v)-(viii) requires additional inputs to actuation unit 460. In particular, scenario (i) requires heating and sterilization, scenario (ii) requires sterilization, scenario (iii) requires heating, scenario (v) requires heating, sterilization, and a dialysis additive, scenario (vi) requires sterilization and a dialysis additive, scenario (vii) requires heating and a dialysis additive, and scenario (viii) requires a dialysis additive.

[0146]

[0170] For scenarios (i), (iii), (v), and (vii) requiring heating of the liquid, it is contemplated that the liquid may be heated (a) before delivery to the filling vessel 432 through the filling line 434, (b) while being delivered to the filling vessel 432 through the filling line 434, (c) while in the filling vessel 432, and (d) any combination thereof. The liquid (water or dialysate) should be heated to approximately 37°C (98°F) or body temperature before delivery to the patient 16. Thus, if the facility 100 is located in a hot climate, it may be possible to store the water or dialysate in a room without air conditioning and heat it an additional number of degrees to the desired temperature in the filling vessel 432. Alternatively or additionally, the water or dialysate may be heated in a larger storage tank in a back room (e.g., storage room 150), discussed below in connection with FIG. 10, before delivery to the filling vessel 432. As a further alternative or addition, a heating coil heated to, for example, about 37°C (98°F) can be wrapped around the fill line 434 to heat the fluid in the fill line. In either of the last two scenarios, heating at the fill vessel 432 may not be required as specified in scenarios (ii), (iv), (vi), and (viii). However, in scenarios (i), (iii), (v), and (vii), additional heating at the fill vessel 432 may be provided so that additional heating can be performed to reach 37°C (98°F) if necessary.

[0147]

[0171] In any of the heating scenarios described involving heating in the filling vessel 432, it is contemplated to provide one or more resistive heating coils or elements 490, as shown in FIG. 8E. In the illustrated embodiment, the heating coils or elements 490 are contained within a heating plate 492 on which the filling vessel 432 rests. The heating plate 492, in turn, can be mounted on top of one or more sensors (e.g., load cells or strain gauges) of the scale 56. The constant weight of the heating plate 492, heating coils or elements 490, and empty filling vessel 432 is either zeroed before the scale 56 reads the weight of the fluid in the filling vessel 432, or is subtracted from the combined detected weight of the empty filling vessel 432, heating plate 492, heating coils or elements 490, and fill fluid.

[0148]

[0172] In one embodiment, the control unit 480 controls the power duty cycle (percent on vs. off or percent of full power) to the heating coils or elements 490 to heat the water or dialysate to approximately 37°C (98°F) as quickly and safely as possible. In one embodiment, two heating coils or elements 490 of the same overall resistance are provided, combined to cover the total area of ​​the heating plate 492. A voltage detection circuit (not shown) is provided with the control unit 480. The voltage detection circuit detects the incoming line voltage and relays it to the processor and memory of the control unit 480. The control unit 480 also includes switching circuitry such that if a higher line voltage (e.g., 190-250 VAC) is detected, the control unit 480 commands the switching circuit to power the dual equal-resistance heating coils or elements 490 in series. If a lower line voltage (e.g., 80-140 VAC) is detected, control unit 480 commands switching circuitry to power dual equal-resistance heating coils or elements 490 in parallel. As a result, coils or elements 490 output approximately the same amount of heating power or wattage regardless of the incoming line voltage. Fill system 430 can therefore be used in various countries with different incoming line voltages and still use the same heating algorithm.

[0149]

[0173] The duty cycle control algorithm used by the control unit 480 to heat the water or dialysate uses temperature feedback from one or more temperature sensors 494, in one embodiment. Temperature sensors 494 are shown in FIGS. 8B, 8D, and 8E, which may be thermistors or thermocouples in various embodiments. As shown in FIGS. 8B and 8C, a permanent metal (e.g., stainless steel) probe 442 extends into the filling vessel 432 to help maintain a sterile environment within the vessel. The probe 442 comes into contact with the water or dialysate as the vessel 432 is filling. Heat from the water or dialysate rises up the metal probe 442 and spreads out, partially exiting the top surface 450 of the filling vessel 432. The portion of the metal probe 442 that extends out of the top surface 450 of the filling vessel 432 extends partway into a coupler 444 that, in one embodiment, is molded with the filling vessel 432. 8B, the coupler 444 leaves room for the temperature sensor 494 to be inserted into the coupler and held in place by the coupler with a press fit. The temperature sensor 494 abuts the metal probe 442, which allows heat from the water or dialysate to be further conducted from the probe 442 to the temperature sensor 494 and create a corresponding signal that is sent back to the control unit 480.

[0150]

[0174] 8C and 8D show that the temperature sensor 494 can be pulled out of the coupler 444 of the filling vessel 432 in order to remove the filling vessel 432 from the actuation unit 460 (e.g., to replace the temperature sensor 494) or for any other desired reason. The probe 442 can be extended any desired distance into the filling vessel 432, such as toward the bottom of the vessel.

[0151]

[0175] In one embodiment, the control unit 480 uses signals from one or more temperature sensors 494 as feedback for its control algorithm. Generally speaking, the further the actual liquid temperature sensed by the one or more temperature sensors 494 deviates below the commanded temperature (e.g., about 37°C (98°F)), the greater the heating duty cycle applied to the coil or element 490. It is contemplated that the control unit 480 will store and use proportional, integral, and derivative ("PID") control to heat the water or liquid to the commanded temperature quickly and with little temperature overshoot.

[0152]

[0176] In scenarios (iii), (iv), (vii), and (viii) above, which do not require sterilization at the filling container 432, sterilization is performed in the preparation room 150 or at an off-site location (e.g., a central location) followed by delivery of the sterilized fluid to the facility 100. Sterilization performed on-site in the preparation room 150 may be accomplished via any of the techniques listed herein, such as in large baths through the use of hydrogen peroxide vapor, gamma irradiation, peracetic acid, ethylene oxide, ethanol, formalin, glutaraldehyde, low-energy electron beam, and / or any other sterilization method known in the art. These methods in the preparation room 150 are preferably performed away from the patient 16 for safety reasons.

[0153]

[0177] With respect to scenarios (i), (ii), (v), and (vi) above, which call for terminal sterilization in the filling container 432, Figures 8D and 8E show that in one embodiment, sterilization panels 462a and 462b are provided with the activation unit 460. In the illustrated embodiment, the sterilization panels 462a and 462b each include a plurality of ultraviolet ("UV") lights 498, such as UV light emitting diodes (UV-LEDs) or UV lamps. The UV lights 498 are connected in series, in one embodiment, via one or more wires or printed circuit board traces 500. In one embodiment, it is contemplated that the inner surface of the sterilization panels 462a and 462b may be a ceramic or FR-4 printed circuit board with one or more copper traces 500 formed thereon. The UV lights 498 are surface mounted to the trace wires 500, for example, in either series or parallel, as desired. Alternatively, the wires 500 form a mesh to which the UV lights 498 can be hardwired, soldered, or otherwise electrically connected. As yet another alternative, the UV lights 498 are UV bulbs that are screwed or plugged into sockets provided by or on the interior surfaces of the sterilization panels 462a and 462b, which may likewise be wired together in series or parallel relationship.

[0154]

[0178] To aid in sterilization of the liquid in the filling container 432 and to improve energy efficiency, it is contemplated that the top surface 450, front surface 452, rear surface 454, and, if necessary, the bottom surface (see FIG. 8C ) of the filling container 432 be formed of or coated with a UV light-reflective material. Side surfaces 456 and 458 of the filling container 432, which are positioned directly adjacent to the sterilization panels 462a and 462b, respectively, are made of a UV light-transmitting material. As shown in FIG. 8C , it is also contemplated that the side surfaces 456 and 458 of the filling container 432 may be made relatively wide and the front surface 452 and rear surface 454 may be made relatively narrow, thereby reducing the required UV light penetration depth. For example, the horizontal length of the side surfaces 456 and 458 may be three or four times the horizontal length X of the front and rear surfaces 452 and 454.

[0155]

[0179] The total disinfecting power from the cumulative light emitted by each of the UV lights 498 of sterilization panels 462a and 462b is sufficient (subject to certain design factors) to sterilize the water or dialysate within a reasonable time period (e.g., 5-10 minutes) or within the duration required to heat the water or dialysate. UV disinfection is believed to be more effective when treating highly purified water (e.g., reverse osmosis or distilled water). Suspended particles can be problematic with UV sterilization because microorganisms embedded within the particles are shielded from UV light. However, it is contemplated that the water or dialysate may be purified before reaching the loading vessel 432 by any of the purification systems discussed herein. This purification system could be located, for example, in the preparation chamber 150 to pre-filter and remove larger organisms before reaching the loading vessel 432. Pure or ultra-pure water or dialysate received in the loading vessel 432 also provides a clearer liquid, improving light transmittance and therefore UV dose throughout the vessel 432. Additionally, because the water or dialysate is trapped within the container 432 and subjected to batch sterilization, the UV light has time and opportunity to reach any remaining particles or microorganisms trapped within the liquid.

[0156]

[0180] It is further contemplated that the UV light 498 will rely on all of the heat delivered to the water or dialysate for its overall heating, and therefore the combination of environmental preheating, heating from the coil or element 490, and heating from the UV light 498 will be sufficient to heat the water or dialysate to body temperature within a reasonable period of time (e.g., the time it takes the patient to drain and / or the time required for proper UV sterilization).

[0157]

[0181] In the illustrated embodiment, there are no sterilization feedback sensors. Appropriate sterilization times are empirically determined based on certain factors, such as the facility's water supply quality, the type and amount of pre-filtration, the sterilization volume in the filling container 432, and the power output from the sterilization panels 462a and 462b. Thus, the sterilization time can be identified as a benchmark. If the environmental pre-heating, heating from the coil or element 490, and heating from the UV light 498 can be effectively performed in the filling container 432 within or approximately the time required for UV sterilization, such heating can be advantageous because it eliminates the need for a separate large-batch heating unit in the preparation room 150 and instead provides on-demand heating in the filling container 432. In such cases, the preparation room 150 may only require a water or dialysate purification unit to purify the fluids needed for each of the patient stations 186a-186n. Additionally, it is contemplated that each of the lines leading to the patient stations 186a-186n (e.g., the filling line 434) may be insulated to reduce heat loss during fluid transfer.

[0158]

[0182] It is contemplated that the heating and / or sterilization associated with activation unit 460 may be automated, eliminating the need for patient 16 to initiate these processes. To this end, in one embodiment, control unit 480 waits until a certain amount of fill liquid has been introduced into fill container 432 before activating heating element or coil 490 and / or sterilization panels 462a and 462b. When scale 56 signals that a predefined amount of fill liquid is present (e.g., 1 / 5 full), control unit 480 activates heating element or coil 490 and / or sterilization panels 462a and 462b. Heating element or coil 490 may be activated before or after sterilization panels 462a and 462b. In some embodiments, control unit 480 requires a predefined weight signal from scale 56 and knowledge that valves 464 and 466 are in the fill state to activate heating element or coil 490 and / or sterilization panels 462a and 462b. This synthetic requirement prevents the heater and sterilization panel from being inadvertently activated by a false weight signal (e.g., located on the filling container 432) when no filling is occurring.

[0159]

[0183] Referring now to FIG. 8G, in any of the above-listed scenarios (v)-(viii) requiring mixing of additives with purified water to create dialysate, it is contemplated to provide sterile packets 510 containing powdered additives that, when mixed with the correct volume of purified or disinfected water, form the precisely formulated, prescribed dialysate. In one embodiment, the patient 16 receives the prescribed sterile packets 510 from the facility staff professional 18 upon approaching the front desk 104 (FIG. 3). In an alternative embodiment, the patient 16 pre-purchased multiple packets 510 and brought one or more packets 510 to the facility 100 with each visit for use. The patient 16 could be provided with packets 510 in various formulations that allow the patient to tailor their treatment based on what they need that day. For example, if the patient 16 is feeling sluggish or overhydrated on a particular day, the patient could select a packet 510 prescribed by their physician for excess ultrafiltration ("UF") removal. Alternatively, if the patient 16 has had UF removed from the previous exchange but desires further removal, the patient may select the prescribed low UF removal packet.

[0160]

[0184] In the embodiment shown in FIG. 8G, packet 510 provides certain information, such as the dialysate type, e.g., by trade name, such as Dianeal™ or Extraneal™ PD Solution. The illustrated packet 510 also specifies dialysis additive components, such as osmotic agents (e.g., glucose levels, dextrose levels, and / or other high and low molecular weight drug levels), buffers (e.g., lactate levels, acetate levels, and / or bicarbonate levels), and / or electrolytes (e.g., sodium levels, calcium levels, magnesium levels, and / or potassium levels). The illustrated packet 510 further specifies the volume of purified water (e.g., 2 liters) that needs to be mixed with the additive. It is expressly contemplated to provide one or more electrolytes (e.g., sodium) at a higher concentration than is typically found in peritoneal dialysis solutions. The reason for this is to increase the conductivity of the dialysate mixed from purified or sterilized water and additives to a level detectable by sensors 494 and 496, as discussed below. Any one or more electrolytes may be elevated as needed for this purpose, but only to a level that is still physiologically safe for patient 16 .

[0161]

[0185] The packet 510 can be sterilized and then sealed (e.g., vacuum sealed), or sealed (e.g., vacuum sealed) and then sterilized. Sterilization can be performed by any of the methods discussed herein. The packet 510 can be configured to tear open at a break point, to cut open near a seam, or to have a tear-off tab. In some embodiments, the packet 510 can also be provided with a readable marking 512, such as a bar code, that can be read by a suitable reader (not shown) located in the filling system 430. The readable marking 512 provides the control unit 480 with information such as the solution type, the required water mix volume, and / or an expiration date. It is therefore expressly contemplated that the packet 510 can tell the control unit 480 how much purified water can be placed in the filling container 432, assuming the patient 16 has been provided with the correct type of packet 510. Thus, the patient identification check discussed above may be unnecessary or may be performed in addition to or as a check based on the information provided by the packet 510. The control unit 480 may also maintain an internal clock of time and date such that if the control unit 480 detects that a packet 510 is out of date, the control unit 480 will sound an alarm, prevent a fill, and / or notify facility staff specialists 18.

[0162]

[0186] 8B and 8C show that in one embodiment, the filling container 432 is provided with a removable (e.g., threaded) cap 440. In some embodiments, the control unit 480 prompts the patient 16 via the display device 484 to remove the cap 440, open the packet 510, and pour the contents of the packet 510 into the unfilled filling container 432. The control unit 480 can then display via the display device 484 a selectable "Empty Packet" button or a message such as "Touch GO when packet is completely empty." After the patient 16 has confirmed that the packet 510 has been emptied into the container 432, according to any identity verification requirements, the control unit 480 commands the filling valve 464 to open to receive the fill. The turbulent flow of purified water entering the filling container 432 completely dissolves and mixes the granulated additives in the packet 510.

[0163]

[0187] 8B-8E show that in some embodiments, the operating unit 460 further includes a conductivity sensor 496. The conductivity sensor 496 operates a temperature sensor 494, which is arranged to form a conductivity sensor pair. The control unit 480 uses the signal from the temperature sensor 494 to compensate for the temperature and signals from the conductivity sensor pair 494 and 496 to generate accurate conductivity readings. As shown in FIGS. 8B and 8C, to help maintain a sterile environment within the filling vessel 432, a permanent metal (e.g., stainless steel) probe 446 extends as far down as necessary into the filling vessel. The probe 446 comes into contact with the water or dialysate when the filling vessel 432 is being filled. Electricity flows through the conductivity sensor 496, probe 446, dialysate, probe 442, and sensor 494 to and from a sensing circuit located within the control unit 480. The higher the conductivity of the dialysate, the greater the current sensed by the sensing circuit.

[0164]

[0188] The portion of the metal probe 446 that extends beyond the top surface 450 of the filling container 432 extends partway into a coupler 448 that, in one embodiment, is molded with the filling container 432. The coupler 448, as shown in FIG. 8B , leaves room for a conductivity sensor 496 to be inserted into the coupler and held in place by the coupler in a press-fit manner. The conductivity sensor 496 terminates at the metal probe 446, allowing electricity from the dialysate to be further conducted from the probe 446 to the temperature sensor 496 and back to the control unit 480. FIGS. 8C and 8D also show that the conductivity sensor 496 can be pulled out of the coupler 448 of the filling container 432 to remove the filling container 432 from the actuation unit 460, to replace the conductivity sensor 496, or for any other desired reason. The probe 448 can extend any desired distance into the filling container 432, including toward the bottom of the container.

[0165]

[0189] In one embodiment, control unit 480 uses the signal from conductivity sensor pair 494 and 496 as confirmation that the dialysate has been mixed with the proper volume of purified water. The primary mixing control is to fill container 432 to the prescribed volume. When this is done, the dialysate should be properly mixed. The conductivity reading can be used as confirmation that the dialysate has been properly mixed. When the powder additive in packet 510 is dissolved with only a small amount of purified water, the conductivity level will be higher than when the additive is dissolved in the prescribed volume. Control unit 480 monitors the decrease in conductivity level as the fill is performed and either verifies that the actual final dialysate conductivity is within the acceptable prescribed range or alarms and / or notifies facility professional 18 if the final conductivity level is outside (higher or lower than) the accepted conductivity range.

[0166]

[0190] Based on the above description of Figures 8A-8G, in one scenario in which all three of heating, sterilization, and dialysate mixing are performed in a permanent or semi-permanent filling system 430, the sequence of events may proceed as follows, by way of example (the steps may not necessarily follow the order described): (i) The patient 16 arrives at the patient station 186b with a dialysis additive packet 510 that they brought from home or obtained at the front desk 104, as well as a reusable drain container 160, a CAPD set 190 or 290, and a new patient transfer set cap 198a. (ii) The patient 16 places the CAPD set 190 or 290 and new patient transfer set cap 198a into the sterilization unit 340 and initiates terminal sterilization of the set and cap. (iii) The patient 16 opens the packet 510, empties its contents into the empty filling container 432, and closes the container. (iv) The patient 16 directly inputs the volume, enters the patient ID, scans the ID tag or scans the packet 510 to load the fill volume into the control unit 480, and after patient and volume verification the fill system 430 begins the fill procedure, which includes filling the container 432 with water and automatically activating fluid heating and final fluid disinfection at some point during the fill. (v) During filling, the patient 16 removes the existing patient transfer set cap 198a and connects the CAPD set 190 or 290 to the patient transfer set, reusable drain container 160 and filling container pigtail 436 (CAPD set 190), or simply connects the patient transfer set and reusable drain container 160 (CAPD set 290), and begins patient drain. (vi) When draining is complete and the ready light 474 is illuminated, indicating that the dialysate volume, sterility, temperature, and composition for patient delivery are satisfied, the patient 16 either (a) initiates a flush sequence from the filling container 432 to the reusable drain container 160, followed by a patient-to-patient pour sequence from the filling container 432 to the patient 16 using the GO and STOP buttons, the flow control device 90, and the CAPD set 190, or (b) removes the distal end of the CAPD set 290 from the reusable drain container 160, connects it to the filling container pigtail 436, and initiates a patient-to-patient pour sequence from the filling container 432 to the patient 16 using the GO button and possibly a pinch clamp if the CAPD set 290 requires priming. (vii) Upon completion of the patient draw sequence or patient fill sequence, the difference between the drain fluid weight and the patient fill fluid weight is recorded manually or electronically as the ultrafiltration (“UF”) removed, which can be logged by the patient 16 and / or reported to facility specialist staff 18 for archival at the treatment facility 100. (viii) The patient collects the used CAPD set 190 or 290, the used patient transfer set cap 198a, and the loaded reusable drain container 160, returns them to the front desk 104, and collects the deposit (if any). (ix) Used CAPD sets 190 or 290, used patient transfer set caps 198a, and loaded reusable drain containers 160 are emptied, if necessary, and disinfected later that day or overnight.

[0167]

[0191] It should be understood that in the above scenario, the treatment facility 100 is completely self-contained and does not require delivery of pickup items. All the facility needs to provide is one or more water purification units, one or more disposable disinfection units (e.g., hot water circulation units), and possibly one or more fill water pre-heating units. The only waste generated is the wrapping of packets 510.

[0168]

[0192] Referring now to FIG. 9, an alternative automated peritoneal dialysis ("APD") device embodiment is shown, in which, after the patient 16 is authenticated or confirmed at the desk 104, the patient 16 is permitted to proceed to a further alternative treatment facility 100 where an APD device 330 is utilized. The APD device 330 will be discussed in more detail below in conjunction with FIGS. 10 and 12. In FIG. 9, alternative patient stations 80a and 80b (any number of which may be provided) separated by walls 82a-82c are arranged horizontally side by side, as opposed to the circular layout shown in FIG. 4. The horizontally arranged APD patient stations 80a and 80b may include any one or more or all of the chair, sofa, bed, etc. 34, television 36, remote control 38, desk or table 40, and / or wall AC outlet 42 discussed above in conjunction with FIG. 4. The stations 80a and 80c may be enclosed, for example, with curtains, walls, and / or doors. In the illustrated embodiment, the APD patient 16 is provided with a bed 34. The APD device 330 is positioned adjacent to the bed 34 to allow the patient line 320 to extend from the heater or fill bag 314 to the patient 16 .

[0169]

[0193] APD therapy will be discussed below in connection with FIG. 12. One important point worth noting here is that the APD device 330 can operate with multiple supply bags 322. All of the supply bags 322 may contain the same type of dialysate (e.g., Dianeal™ PD solution). Alternatively, the supply bags 322 may contain different types of dialysate (e.g., two bags containing Dianeal™ PD solution and one containing Extraneal™ PD solution) to tailor the PD therapy. Furthermore, it should be understood that APD therapy using the APD device 330 at the facility 100 of the present disclosure can only be performed with a single exchange using only a single supply bag 322, and that this single supply bag 322 may be positioned on the device 330 for heating. In FIG. 9, a heater bag 314, which can be used with multiple supply bags, is positioned on a heater pan positioned on top of the APD device 330.

[0170]

[0194] An APD patient using device 330 drains from the cassette through drain line 316 into drain bag 324. An APD patient using device 330 fills heater bag 314 from supply bag 332, where the PD solution is heated, for example to 37°C, and then from heater bag 314 to the patient's peritoneum.

[0171]

[0195] Referring now to FIG. 10 , a top plan view illustrates one possible layout of a facility 100 for use in any of the scenarios and settings discussed in FIGS. 1-6 above. As discussed above in connection with FIGS. 1 and 2 , the facility 100 can be located in any suitable type of building, such as a standalone building, a building along a busy urban street, a building within a mall, a building as part of a larger building, a transportation station, or the like. The facility 100 can also be located at a workplace or within a residence, which advantageously allows patients to receive treatment before, during, or after work, minimizing disruption to their work or home schedules. Alternatively, the facility 100 can be located in or near a residence, hostel, or other temporary accommodation facility, allowing residents of the residence or accommodation facility to conveniently receive treatment without having to own their own dialysis equipment. Such facilities are particularly useful in developing countries where a large proportion of residents do not have access to or the means to own dedicated home dialysis machines. Additionally, some countries provide temporary accommodations near workplaces so that employees can live near their workplaces during the week and return home on weekends. The facilities of the present disclosure can be located at or near any such temporary accommodations.

[0172]

[0196] The facilities 100 allow patients to perform exchanges before, during, and / or after work, as desired. For example, a patient may perform a first exchange at a facility 100 located between home and work, a second exchange at a second facility 100 near or at work between work sessions, and a third exchange at the first facility 100 while returning home from work. The system hub 520 of systems 10 and 110, discussed below in connection with Figures 14 and 15, can collect and analyze patient data from multiple facilities 100 together, as if the patient were using only one facility 100.

[0173]

[0197] As shown in FIG. 10 and in connection with FIGS. 1-3 above, facility 100 includes door 102 through which patient 16 enters. After patient 16 enters through door 102, patient approaches desk 104 (also shown in FIG. 3 ) and speaks with facility professionals staffed at computers 106 a- 106 f. While FIG. 10 shows facility 100 with room for six facility professionals 18 ( FIG. 3 ) staffed at six computers 106 a- 106 f, facility 100 may instead have any number of computers 106 (generically referring to any of computers 106 a- 106 f) and / or facility professionals desired. For example, in a smaller community setting, facility 100 may have only a single computer or one professional. Computer 106 may be a desktop computer, a laptop computer, a tablet, or a computer / tablet hybrid. Mobile laptop computers, tablets, and computer / tablet hybrids allow facility staff professionals 18 to move around facility 100 and perform multiple functions, such as managing duties at front desk 104, working desks in different rooms of facility 100, providing care or instruction to patients, and / or operating supply rooms. In the illustrated embodiment, computer 106 communicates wirelessly with web portal 524 or 560 (shown in FIGS. 14 and 15 below) via wireless transceiver 108.

[0174]

[0198] After a patient is identified according to any of the methods or procedures discussed herein, the patient enters a hall through door 110 and proceeds through the hall to the appropriate clearly labeled exchange room door 112, 114, or 116. The exchange room entered through door 112 is a batch peritoneal dialysis treatment area 200, where multiple peritoneal dialysis patients can receive fills from the same large batch of a designated type of solution (discussed in detail in connection with FIG. 11). The exchange room entered through door 114 is an automated peritoneal dialysis ("APD") device treatment area 300, where multiple patients each use an in-center APD device (discussed in detail in connection with FIG. 12). The exchange room entered through door 116 is a continuous ambulatory peritoneal dialysis ("CAPD") treatment area 400, where multiple patients each use a CAPD exchange device (discussed in detail in connection with FIG. 13). Facility 100 may have one, more, or all of batch peritoneal dialysis treatment area 200, APD device treatment area 300, and / or CAPD treatment area 400. As a further alternative, the treatment area(s) of facility 100 may be a hybrid of any combination of treatment areas 200, 300, and 400.

[0175]

[0199] 10 shows that batch peritoneal dialysis treatment area 200 includes multiple large dialysis solution tanks 210a, 210b, 210c, and 210d, each capable of holding dialysate with a different dextrose or glucose level. Alternatively, dialysate solution tanks 210a-210d can hold dialysate formulated with low levels of dextrose or glucose, or without dextrose or glucose. For example, glucose-free dialysate is commercially available under the trade names EXTRANEAL™ and NUTRINEAL™ from the assignee of the present disclosure. Well-known and accepted dextrose levels range from 0% to 4.25%, for example, and well-known and accepted glucose levels range from 0% to 3.86%, for example.

[0176]

[0200] Batch peritoneal dialysis treatment area 200 also includes multiple common drain areas 250. Alternatively, patients within batch peritoneal dialysis treatment area 200 drain into drain bags or individual drains. Multiple sterilization units 244, such as ultraviolet (“UV”) sterilizers, are provided for dialysis solution tanks 210a, 210b, 210c, and 210d and common drain area 250 to allow patients to sterilely connect and disconnect the dialysis solution tanks to each other. Batch peritoneal dialysis treatment area 200 may or may not require patient disposables, but in either case should generate less disposable waste than APD device treatment area 300 and / or CAPD treatment area 400.

[0177]

[0201] Because facility 100 may use hundreds of disposable sets per day, it is desirable to recycle and / or reuse as many disposable sets as possible. Some components of the set and / or packaging remain dry and can be easily re-sterilized for reuse. Such disposable components include, for example, plastic parts (e.g., caps, plastic bags), paper, and cardboard from the packaging that do not contact the effluent dialysate. However, any tubing and pump sections associated with the disposable set that come into contact with the fluid are biohazardous after use and are handled with more care. Wet disposable parts can be collected in a sealed container to prevent contact with external materials and prevent the spread of biohazards. This container can be transported to a location where the wet disposable parts are disinfected with a chemical sterilizing solution (or others listed above) and recycled or reused. This disinfection is performed in a biohazardous environment due to the potential for exposure to human blood, for example, from people who may be infected with hepatitis or acquired immune deficiency syndrome ("AIDS"). Where tubing cannot be sterilised for recycling or reuse, it is instead labelled as biohazard, packaged and handed over to a licensed biohazard waste collection company.

[0178]

[0202] Similarly, any used dialysate or fluid that cannot be recycled or reused is disposed of as a biohazard. CAPD patients often dispose of effluent dialysate by pouring the fluid down the sewer. However, because a facility 100 may dispose of hundreds of liters of used dialysate each day, the facility may disinfect the used dialysate before discarding it. Particular care is taken to ensure that disposal of any biohazardous materials complies with Control of Substances Hazardous to Heath ("COSHH"), Occupational Safety and Health Administration ("OSHA"), and Environmental Protection Agency ("EPA") regulations.

[0179]

[0203] When a patient enters the batch peritoneal dialysis treatment area 200, the patient approaches desk 120a and hands an attendant an order received from one of the computers 106 at front desk 104. Otherwise, the order is sent from one of the front desk computers 106a-106f to computer 106g in treatment area 200. As a further alternative, facility staff professionals 18 escort the patient from the front desk area to the batch peritoneal dialysis treatment area 200 and enter the patient's order, for example, via the staff professional's mobile laptop computer, tablet, or computer / tablet hybrid. In either case, the order is entered for billing purposes at this time. The patient may or may not be charged a copay at front desk 104. If the batch peritoneal dialysis treatment area 200 does not have any disposables needed for the treatment, facility staff professionals 18 either pull disposables from behind treatment area desk 120a or enter storage room 150 through door 122 to obtain disposables. Again, patients in batch peritoneal dialysis treatment area 200 may not need any disposables at all.

[0180]

[0204] If a patient in batch peritoneal dialysis treatment area 200 is currently filled with used dialysis fluid, the patient connects to one of the common drain areas 250 via the patient's transfer set. This connection can be made using a sterilization unit 244 and / or a cleaning agent, such as an alcohol wipe. The patient then drains the used fluid, for example, while in a seated position, ensuring as complete a drain as possible. After draining, the patient proceeds to the designated dialysis solution tank 210a, 210b, 210c, or 210d for filling. The patient then connects their transfer set to the designated solution tank, again using a sterilization unit 244 and / or a cleaning agent, such as an alcohol wipe. The patient then performs the peritoneal dialysis filling procedure, as described in more detail in connection with FIG. 11 .

[0181]

[0205] The patient may wait for a dwell period and perform the above-described exchange again, and may do so multiple times if desired. Alternatively, the patient may perform a single exchange and then leave facility 100. While in batch peritoneal dialysis treatment area 200, the patient may, for example, watch television via television 118a, work on their computer, read, or connect to the Internet via wireless transceiver 108. It is contemplated that the patient (e.g., with the assistance of facility staff professional 18) may weigh themselves with scale 130 and take their blood pressure with blood pressure cuff 132. Before draining and / or after draining and / or filling, the patient's weight and / or blood pressure may be recorded. The same recording may also be performed for patient glucose monitoring. The patient may record the reading and communicate it to the staff professional, the staff may record the reading, or the reading may be wirelessly transmitted from scale 130 and / or pressure cuff 132 to treatment area computer 106g or a front desk computer. All therapy data, such as the patient's weight, blood pressure, glucose levels, output(s), and fill(s), are recorded and logged. Patient data can be sent to the patient's clinic or hospital 522a, 522b, or 522c (FIGS. 14 and 15). One clinician system for receiving and tracking peritoneal dialysis patient data is shown and described in U.S. patent application Ser. No. 13 / 828,900, filed Mar. 14, 2013, entitled "Home Medical Device Systems And Methods For Therapy Prescription And Tracking, Servicing And Inventory," the entire contents of which are incorporated herein by reference and relied upon.

[0182]

[0206] Large dialysis solution tanks 210a, 210b, 210c, and 210d are sterilized fluid tanks (e.g., rigid plastic or stainless steel tanks) that are intended to be removed through storage room 150 via door 122 when empty and replaced with full tanks 210 containing dialysis fluid with the same dextrose or glucose levels from storage room 150. Empty tanks 210 can be shipped to a factory, sterilized while empty, for example, with ethylene oxide, and then filled in a controlled sterilization manner with sterilized dialysis fluid having the desired dextrose or glucose levels, after which the refilled tanks 210 can be shipped back to facility 100. In an alternative embodiment, large dialysis solution tanks 210a, 210b, 210c, and 210d remain in place within batch peritoneal dialysis treatment area 200 and are sterilized when empty, for example, with ethylene oxide, and then refilled on-site in a sterile manner with sterilized dialysis fluid having the desired dextrose or glucose levels. The tank 210 inside the storage room 150 may therefore be an even larger sterile tank for refilling the tanks 210a, 210b, 210c and 210d located in the batch peritoneal dialysis treatment area 200.

[0183]

[0207] It is further contemplated that facility 100 may include an on-site sorbent system for regenerating effluent dialysate into usable dialysate. Such a sorbent system removes unwanted components (e.g., toxins, fiber, and metabolic waste products) in the effluent dialysate obtained from the patient. The sorbent system may also add desirable components (e.g., dextrose, glucose) and electrolytes (e.g., potassium, calcium) to restore the dialysate while maintaining a desired osmotic gradient for ultrafiltration removal from the patient. One known sorbent system uses a sorbent cartridge that absorbs uremic toxins, such as urea, creatinine, uric acid, and other metabolic by-products. As the effluent dialysate passes through the sorbent cartridge, unwanted components are removed from the dialysate and the dialysate emerges usable for additional therapy. An infusate is then pumped into the purified dialysate to add salts and / or carbohydrates as needed. Suitable sorbent systems and corresponding methods are set forth in U.S. Pat. No. 7,208,092, entitled "Systems and Methods for Peritoneal Dialysis," U.S. Pat. No. 7,867,214, entitled "Systems and Methods for Performing Peritoneal Dialysis," and U.S. Pat. No. 7,922,686, entitled "Systems and Methods for Performing Peritoneal Dialysis," the entire contents of each of which are incorporated herein by reference and relied upon.

[0184]

[0208] The sorbent system can be installed at facility 100 so that large batches of effluent dialysis fluid removed from multiple patients can be regenerated at once. Alternatively, the sorbent system is configured to instantly and individually regenerate effluent dialysate as it is removed from each patient. Using a sorbent system to regenerate effluent dialysate collected by facility 100 reduces the amount of unused dialysate that must be transported to and stored by facility 100. The use of such a sorbent system also reduces the amount of waste fluid that facility 100, as discussed above, must handle and dispose of.

[0185]

[0209] Alternatively, or in addition to sorbent regeneration, facility 100 can provide other forms of effluent cleaning for regeneration, such as any one or more of electrodialysis ("ED"), electrodialysis reversal ("EDR"), electrodeionization ("EDI"), ultrafiltration, reverse osmosis filtration, ultraviolet radiation, or ozone. Ozone can be generated online by exposing oxygen to ultraviolet light. This ozone can then be drawn into the effluent dialysate stream, such as via a venture pump. Ozone tends not to be well stored under positive pressure.

[0186]

[0210] It is further contemplated that facility 100 may include a water purification system for reusing at least a portion of the water separated from the effluent dialysate. Even if the effluent dialysate is not regenerated into usable dialysate, removing and purifying water from the effluent dialysate can reduce the volume of waste fluid requiring disposal. The purified water can then be used for other purposes in facility 100, including the preparation of unused dialysate, either online or at the point of use. In addition to purifying the water separated from the effluent dialysate, water purification systems can be installed for receiving tap water, purifying tap water, and preparing dialysate online using the purified tap water, either by using unused concentrate or in combination with the sorbent system described above. One suitable water purification system is shown in U.S. Patent Publication No. 2011 / 0197971, entitled "Water Purification System and Method," filed April 25, 2011, the entire contents of which are incorporated herein by reference and relied upon. In one embodiment, the purification system includes a filter for purifying tap water (e.g., removing pathogens and ions such as chlorine) so that the water preferably has less than 0.03 endotoxin units / ml (“EU / ml”) and less than 0.1 colony forming units / ml (“CFU / ml”).

[0187]

[0211] Referring again to FIG. 10 , when a patient enters the APD device treatment area 300, the patient approaches desk 120b and hands an attendant an order received from one of the computers 106 at the front desk 104. Otherwise, the order is sent from one of the front desk computers 106a-106f to computer 106h in treatment area 300. As a further alternative, facility staff professionals 18 escort the patient from the front desk area to the APD device treatment area 300 and enter the patient's order, for example, via the staff professional's mobile laptop computer, tablet, or computer / tablet hybrid. In either case, the order is entered for billing purposes at this point and may again include a copayment at the front desk 104. Each of the APD device treatment stations 310a-310j in the APD device treatment area 300 uses a disposable set 312 operable with an APD device 330, as described in more detail below in connection with FIG. 12 . The facility staff member retrieves the disposable set 312 by either pulling it from behind the treatment area desk 120b or by entering the storage room 150 through the door 124. One suitable APD device is the HomeChoice™ or HomeChoicePro™ device offered by the assignee of the present disclosure.

[0188]

[0212] If a patient in the APD device treatment area 300 is currently filled with used dialysis fluid, the patient connects to one of the common drain areas 250 via a patient transfer set, which again can be accomplished with a sterilization unit 244 and / or a cleaning agent such as an alcohol wipe. The patient then drains the used fluid, for example, while seated, to ensure as complete a drainage as possible. Alternatively, drainage can be performed automatically, with the APD device 330 pumping spent fluid from the patient into a drain bag provided as part of the disposable set 312. After draining, the patient proceeds to (or is already at) a designated APD device treatment station 310a-310j for filling. Unlike in the batch peritoneal dialysis treatment area 200, the disposable set 312 will be provided with a fill bag(s) containing the patient's prescribed dialysate dextrose or glucose level and prescribed fill volume. Thus, the particular APD device treatment station 310a-310j at which the patient performs the treatment may not be important, as long as the device is capable of accepting and operating the disposable cassette 312 provided to the patient. Different versions of the device 330 may exist at the stations 310a-310j, and the patient may prefer a particular version of the device 330, for example, programming or user interface reasons. The patient connects their transfer set to the disposable set 312 in a sterile manner, for example, by using the sterilization unit 244 and / or a cleaning agent such as an alcohol wipe. The patient may be able to load the disposable set 312 into the APD device 330, program the treatment, and administer the treatment. In this alternative, one of the facility's specialized staff may assist the patient with any one or more or all of loading the disposable set 312, programming the treatment, and / or administering the treatment. After the disposable set 312 is loaded into the APD device 330, the device 330 performs an automated peritoneal dialysis filling procedure as described in more detail below.

[0189]

[0213] As with batch therapy, the patient in APD treatment area 300 may wait a dwell period and perform the above-described exchange again, and may do so multiple times if desired. Alternatively, the patient may perform a single exchange and then leave facility 100. While in device 330, the patient may, for example, watch television via television 118b, work on their computer, read, or connect to the Internet via wireless transceiver 108. As above, it is contemplated that the patient, with assistance from facility staff 18, may weigh themselves with scale 130 and / or take their blood pressure with blood pressure cuff 132. Before and / or after draining and / or filling, the patient's weight and / or blood pressure may be recorded. The same recording may also be performed for the patient's glucose monitoring. All of the treatment data, such as the patient's weight, blood pressure, glucose levels, output(s) and fill(s), can again be recorded, logged and sent to the patient's clinic or hospital 22a, 22b or 22c.

[0190]

[0214] Storage room 150 contains spare APD devices 330 and disposable sets 312. Storage room 150 also stores spare disposable sets 412 for stations 410a-410l of continuous ambulatory peritoneal dialysis ("CAPD") treatment area 400, discussed next. Storage room 150 also stores spare sterilized units 244, weigh scales 130, blood pressure cuffs 132, glucose monitors (not shown), and other desired equipment for any of treatment areas 200, 300, and 400. Suitable sterilization units are described in U.S. patent application Ser. No. 11 / 773,623, entitled "Peritoneal Dialysis Patient Connection System," filed July 5, 2007, and U.S. patent application Ser. No. 11 / 773,824, entitled "Peritoneal Dialysis Patient Connection System Using Ultraviolet Light Emitting Diodes," filed July 5, 2007, the entire contents of each of which are incorporated herein by reference and relied upon.

[0191]

[0215] Alternatively, when a patient enters the CAPD treatment area 400, the patient approaches desk 120c and hands an attendant an order received from one of the computers 106 at the front desk 104. Alternatively, the order is sent from one of the front desk computers 106a-106f to computer 106i in the treatment area 400. As a further alternative, a facility staff professional escorts the patient from the front desk area to the APD device treatment area 400 and enters the patient's order, for example, via the staff professional's mobile laptop computer, tablet, or computer / tablet hybrid. In either case, the order is entered for billing purposes at this point and may again include a copayment at the front desk 104. Each of the CAPD treatment stations 410a-410l in the CAPD treatment area 400 uses a disposable set 412 that is manually operated by the patient. The facility staff member retrieves the disposable set 412 by either pulling it out from behind the treatment area desk 120c or by entering the storage room 150 through the door 124.

[0192]

[0216] If a patient in CAPD treatment area 400 is currently filled with used dialysis fluid, the patient connects to one of the common drain areas 250 via a patient transfer set, which can again be performed using a sterilization unit 244 and / or a cleaning agent such as an alcohol wipe. Drainage can alternatively be performed manually, with the patient gravity-feeding spent fluid from the patient into a drain bag provided as part of disposable set 412. The patient then drains the spent fluid, for example, while seated, ensuring as complete a drainage as possible. After draining, the patient proceeds to (or is already at) a designated CAPD treatment station 410a-410l for filling. Unlike in batch peritoneal dialysis treatment area 200, disposable set 412, like disposable set 312, will be provided with a fill bag(s) containing the patient's prescribed dialysate dextrose or glucose level and prescribed fill volume. Thus, the particular CAPD treatment station 410a-410l at which the patient performs treatment is not important. The patient will likely connect themselves to the disposable set 412 for treatment. In this alternative, one of the facility's professional staff may assist the patient in connecting to the disposable set 412. The patient connects their transfer set to the disposable set 412 in a sterile manner, for example, by using the sterilization unit 244 and / or a cleaning agent such as an alcohol wipe. The patient then performs the manual peritoneal dialysis filling procedure as described in more detail below.

[0193]

[0217] As an alternative to storing dialysate with predetermined levels of glucose and dextrose, ratio-adjusted solutions may be prepared on demand at the facility. In one embodiment, the facility 100 may include separate containers for fresh dialysate, water, other concentrates, or solutions containing desired components, such as glucose, dextrose, and electrolytes, in liquid form. Alternatively, dry chemicals or concentrated chemical reagents may be used in place of liquid concentrates, reducing the space required to store the concentrates. The facility 100 mixes the dialysate, water, salts, concentrates, and / or other chemicals and solutions on demand based on each patient's prescription. For example, one method for preparing fresh dialysate is to mix an acid concentrate with a bicarbonate concentrate and then dilute the resulting mixture with water. In this example, the acid concentrate may be stored at different ion concentrations, and the bicarbonate concentrate may be stored as sodium bicarbonate and / or sodium bicarbonate mixed with sodium chloride. The concentrates are then mixed on-site to prepare fresh dialysate according to the patient's specified prescription. On-site mixing of dialysate allows facility 100 to reduce the amount of disposable packaging consumed by using pre-mixed dialysate. Alternatively, dialysate can be prepared as needed using larger containers of concentrate and / or chemicals to prepare the dialysate online. One suitable system and method for mixing peritoneal dialysis solution is shown in U.S. Pat. No. 5,925,011, entitled "System and Method for Providing Sterile Fluids for Admixed Solutions in Automated Peritoneal Dialysis," the entire contents of which are incorporated herein by reference. The admixed dialysate solution can be provided to the patient, for example, by dispensing the liquid into a heated / measured bag that is provided to the patient for dialysis treatment.

[0194]

[0218] As with treatment in areas 200 and 300, a patient in CAPD treatment area 400 may wait a dwell period and perform the above-described exchange again, and may do so multiple times if desired. Alternatively, the patient may perform a single exchange and then leave facility 100. While in treatment stations 410a-410l, the patient may watch television, for example, via television 118c, work on the patient's computer, read, or connect to the Internet via wireless transceiver 108. Similarly, it is contemplated that the patient, with assistance from facility staff professional 18, may weigh themselves with scale 130 and take their blood pressure with blood pressure cuff 132. Patient weight and / or blood pressure may be recorded before and / or after draining and / or filling. The same can be done for patient glucose monitoring. All of the treatment data, such as the patient's weight, blood pressure, glucose levels, output(s) and fill(s), can again be recorded, logged and sent to the patient's clinic or hospital 22a, 22b or 22c.

[0195] Facility Treatment Area

[0219] Referring now to FIG. 11, one embodiment of the batch peritoneal dialysis treatment area 200 discussed above is shown. The batch peritoneal dialysis treatment area 200 dispenses prescribed types of dialysis solution in specified amounts. The batch peritoneal dialysis treatment area 200 may be part of the treatment facility 100 discussed above and includes large dialysis solution tanks 210a, 210b, 210c...210n, which are multi-treatment containers of different select peritoneal dialysis solutions, such as those with the glucose or dextrose levels listed above. For example, each tank 210a, 210b, and 210c may contain a different dialysis solution 212a, 212b, and 212c, for example, with a different dextrose level (e.g., 1.5%, 2.5%, and 4.25% dextrose) or glucose level (e.g., 1.36%, 2.27%, and 3.86% glucose), at known and approved levels.

[0196]

[0220] Tanks 210a-210c can be stainless steel or plastic and, in some embodiments, can be sterilized, for example, by ethylene oxide sterilization. Tanks 210a-210c can have integrated casters for transportation or can tilt for loading and unloading onto a rolling pallet or forklift for transportation. In the illustrated embodiment, tanks 210a-210c each include a heater 214, such as an infrared or ultraviolet radiant heater, connected to the glass or other radiation-transmitting window or compartment of the tank. Heater 214 can alternatively be a resistive heater (not shown) mounted on the tank. In either case, heater 214 receives power or duty cycle signals from control unit 215. Control unit 215 can be, for example, a microcontroller (e.g., including a processor and memory) located in a box together with heater 214. A temperature sensor 216, such as a thermocouple or thermistor, is located inside each tank 210a-210c and detects and feeds a temperature signal to a microcontroller for temperature (e.g., duty cycle) control of the dialysis fluid. The microcontroller may be connected to a wireless modem that is wirelessly linked via transceiver 108 to batch area computer 106g and / or one of front desk computers 106a-106f.

[0197]

[0221] Additionally, there may be an analog output level sensor 218, such as an ultrasonic or laser sensor, mounted on top of the tanks to detect the level of dialysate within the tanks 210a-210c and send an indicative signal to a microcontroller housed within the heater 214 housing. Alternatively, the level or volume of the liquid may be confirmed by a scale (not shown) located beneath each tank 210a-210c. In one embodiment, the scale itself may send a wireless weight signal to the batch area computer 106g and / or one of the front desk computers 106a-106f. In these embodiments, the temperature and level (or volume) of the dialysate within each tank 210a-210c may be remotely monitored. Additionally, the remote computer may include software to alert facility staff that a tank 210a-210c will soon need to be switched or refilled.

[0198]

[0222] It is further contemplated that the tanks 210a-210c may be constructed from a translucent material, such as translucent plastic, so that the dialysis fluid level within the tank can be viewed from outside the tank. Additionally, each tank 210a-210c may be provided with a hydrophobic or high-efficiency particulate air ("HEPA") filter 219, for example, at the top of the tank, to allow filtered air to enter the tank and displace spent dialysis fluid, preventing negative pressure within the tank.

[0199]

[0223] In the illustrated embodiment, each tank 210a-210c is provided with multiple peritoneal dialysis supply distributors (e.g., distributors 220a-220f). The distributors 220a-220f may be attached (e.g., foldably attached) to the tanks 210a-210c. In this manner, the distributors are transported with the tanks for sterilization, inspection, and repair. Alternatively, the distributors 220a-220f may be individually transported to the facility 100 in sterile bags (not shown), stored in the storage room 150, removed from the sterile bags, and connected to one of the tanks 210a-210c in a sterile manner, for example, using a sterilization unit 244 and / or a sterile cleaning agent such as alcohol, when needed.

[0200]

[0224] Distributor 220a of tank 210a is a detailed view of one distributor embodiment. Distributor 220a includes supply line 222, pressure regulator 224 for controlling downstream pressure, metering device fill valve 226, metering device 228, metering device dispel valve 232, and flexible line 234 leading to check valve 236 and distributor connector 238. Dialysis fluid in tanks 210a-210c is gravity-fed to the patient. The large volume of dialysis fluid held in the tanks can create a large pressure drop. Pressure regulator 224 keeps the pressure of the dialysis fluid downstream of the regulator within a more manageable range (e.g., 5-10 psig).

[0201]

[0225] Metering device 228 includes level sensors 230a and 230b operable as an emission and reception (e.g., optical or laser emission and reception) pair. Level sensors 230a and 230b are moved up and down along the scale of metering device 228 by patient 16 or facility professional 18 to the prescribed fill level. Although not shown, a ball-screw type translation device can be provided with metering device 228 to precisely translate level sensors 230a and 230b to the prescribed fill level by manual or motorized screw rotation. To fill metering device 228, dispel valve 232 is closed while fill valve 226 is opened, allowing liquid to fill the metering tube under a manageable pressure and corresponding flow rate.

[0202]

[0226] Control unit 215 is programmed to close fill valve 226 when dialysis fluid fills the metering tubing and the level obstructs the light or energy beam traveling from level sensor 230a to sensor 230b. Valves 226 and 232 and level sensors 230a and 230b are electronically controlled via tank control unit 215 in the illustrated embodiment. It is further contemplated that a filtered air port (not shown) may be located at the top of metering device 228, as well as filter 219, so that pressure does not build up in the tubing of metering device 228 and that any air entering supply line 222 from tanks 210a and 210c is forced under pressure to or from the top of metering device 228.

[0203]

[0227] For patient fill from metering device 228, fill valve 226 is maintained closed while dispel valve 232 is opened. Fluid is gravity-fed at a safe, low pressure through dispel valve 232, flexible line 234, check valve 236, and connector 238, through patient transfer set 242, and into patient 16 via the patient's indwelling implanted catheter. Prior to fluid delivery, the patient makes a sterile connection of patient transfer set 242 to distributor connector 238 via, for example, sterilization unit 244 and / or a germicidal cleaning agent such as an alcohol wipe. Check valve 236 prevents patient fluid from migrating into supply line 222. Furthermore, supply line 222 is maintained in a fully primed state between uses. Distributor connector 238 is configured so that no fluid can exit supply line 222 through check valve 236 unless patient transfer set 242 is engaged with distributor connector 238. For this purpose, the dispenser connector 238 may be provided with an on / off valve (not shown). The dispenser connector 238 may also have a disposable tip (not shown) that is replaced by a sterilized tip before each use.

[0204]

[0228] Metering device 228 may alternatively include other devices capable of monitoring and metering the flow of dialysis solution to meet the volume of dialysis solution 212a-212c predetermined by the patient's prescription. In an alternative embodiment, metering device 228 includes an integrating flow meter that monitors and integrates the dialysate flow rate versus time to determine when the patient has received the prescribed amount of dialysis solution.

[0205]

[0229] In another alternative embodiment, metering device 228 includes a balance chamber having a chamber of known, fixed volume defined by a membrane or diaphragm that flaps back and forth between the inner walls of the chamber separated by the membrane or diaphragm. Pressurized dialysate flowing from tanks 210a-210c is split into two inlet lines, each leading to a different side of the membrane. Each inlet line is valve-controlled. The valves are sequenced to push dialysate into the chamber from alternate sides of the membrane, with the same volume of dialysate each time being forced out of the chamber on the other side of the membrane facing the patient. Thus, there are also two outlet lines, one leading from the chamber toward the patient on each side of the membrane or diaphragm, each outlet line also valve-controlled, with the valves on the outlet lines sequenced in sync with the valves on the inlet lines, and the inlet valve on one side of the membrane opens and closes with the outlet valve on the other side of the membrane, and vice versa. The valve-controlled outlet lines are tied together to form a single outlet line to the flexible line 234, check valve 236, connector 238, and patient 16. The control unit 215 counts or knows how many times the valves have been sequenced. Multiplying this number by the known volume of the chamber yields the ever-increasing total volume to be pumped to the patient. When the actual total volume pumped equals the prescribed total volume, the exchange fill is complete and the balance chamber valve is closed. The prescribed total volume can then be electronically entered into the control unit 215 for the tanks 210a-210c via (i) a user interface or keypad provided with the dispensers 220a-220f, or (ii) a computer, tablet, or computer / tablet hybrid of one of the facility's specialist staff members in wireless communication with the control unit 215.

[0206]

[0230] In many instances, a patient 16 will enter the batch peritoneal dialysis treatment area 200 with spent dialysis solution in their peritoneum that must first be drained. To do this, the patient 16 may first connect to either (i) a drain bag (not shown) that is subsequently weighed and / or sampled and then discarded, or (ii) an individual drain (not shown). However, in the illustrated embodiment, the patient 16 may instead drain to a common drain area 250, discussed above in connection with FIG. 10 . The common drain area 250 includes a reservoir or basin 252. A plurality of valve-controlled drain line assemblies 254 a-g extend from the reservoir or basin 252. Each valve-controlled drain line assembly 254 a-g includes a three-way valve 256 that allows drain fluid to flow either from the patient 16 to a reusable weigh bag or container 258 or from the weigh bag or container 258 to the reservoir or basin 252. In one embodiment, neither position of valve 256 allows fluid to flow from patient 16 to drain tank or basin 252, forcing the patient to drain into weighing bag or container 258. The patient connects to valve 256 via sterilization unit 244 and / or sterilizing agent as previously discussed above.

[0207]

[0231] As shown, each weigh bag or container 258 is mounted on a scale 260. The scale 260 can wirelessly transmit the patient's output weight via the transceiver 108 to the computer 106a-106g, which then logs the output volume along with the other exchange data discussed above for transmission to the patient's clinic 22a-22c. The effluent weight data transfer to the computer 106a-106g is alternatively performed manually, as previously discussed herein. In some embodiments, the weigh bag or container 258 is provided with a sample port (not shown) that allows for the acquisition of an effluent sample, which can be provided to facility staff professionals 18, for example, at the batch area desk 120a or front desk 104, for possible analysis while the patient 16 is performing their exchange. The results can be provided to the patient upon leaving the facility 100 and / or logged as part of the exchange data sent to the patient's clinic 22a-22c. While metering the discharged dialysate to track patient output volume for patient volume and ultrafiltration control is desirable, it is contemplated that not all facilities 100 have the means or resources to meter the discharged dialysate. In such cases, the patient may instead drain the effluent dialysate into a common drain without such metering.

[0208]

[0232] After the patient's drainage into the weigh bag or container 258 is complete, the patient or facility professional 18 may lift the bag or container 258, for example, onto a hook or overhang provided by the tank or basin 252, positioning it high above both the valve 256 and the connection of each drain line 254a-254g to the tank or basin. The position of the valve 256 is then switched to allow the patient's effluent to flow by gravity from the weigh bag or container 258 to the tank or basin 252. The tank or basin 252 is constructed and arranged to efficiently and effectively handle biological waste, such as spent dialysate from the patient's peritoneum.

[0209]

[0233] Referring now to FIG. 12 , one embodiment of the APD device peritoneal dialysis treatment area 300 discussed above is shown. The APD device peritoneal dialysis treatment area 300 dispenses a prescribed volume of dialysis solution of a prescribed type and can be part of the treatment facility 100 discussed above. The treatment area 300 includes APD device treatment stations 310a-310d, each of which provides a disposable set 312 operable with an APD device 330. Each disposable set 312 can contain a different dialysis solution, for example, having a different dextrose level (e.g., 1.5%, 2.5%, and 4.25% dextrose) or glucose level (e.g., 1.36%, 2.27%, and 3.86% glucose), at known and approved levels. Each disposable set 312 can also contain a prescribed volume of the prescribed type of dialysis solution. Alternatively, the disposable set 312 may contain more than the prescribed volume of dialysate and rely on the APD device 330 to pump the prescribed volume of dialysate to the patient 16.

[0210]

[0234] The disposable set 312 may include only a single dialysate filled bag 314, where the patient can drain into the common drain area 250, including all of the alternatives already discussed above in connection with Figures 10 and 11. When the patient drains into the common drain area 250, the disposable set 312 does not require a drain bag or associated drain line or tubing. Alternatively, the disposable set 312 includes a drain bag that attaches to the drain line 316, which allows the APD device 330 to automatically drain the patient. As yet another alternative, the APD device 330 pumps the patient effluent via the drain line 316 to an individual drain.

[0211]

[0235] In the illustrated embodiment, the dialysate fill bag 314 rests on a heater 332 located on top of the APD device 330. The heater 332 heats the dialysate in the fill bag 314 to or near the patient's body temperature (e.g., approximately 37°C). However, it is expressly contemplated that the fill bag 314 may be preheated as part of a disposable set 312 stored in the storage compartment 150 to reduce or eliminate the heating time before patient filling can begin. Tubing 318 routes the heated dialysate pumped from the fill bag 314 into and through a disposable pumping cassette loaded into the APD device 330 and is therefore not visible in FIG. 12 . One suitable disposable pumping cassette is shown and described in U.S. Pat. No. 5,989,423, the entire contents of which are incorporated herein by reference and relied upon. The APD device 330 then pumps the heated dialysate from the cassette through the patient line 320 to the patient 16. The disposable pumping cassette allows the APD device 330 to pump the precise fill volume of dialysate prescribed to the patient's peritoneum. In one embodiment, the prescribed volume is manually entered into the control unit (including processing and memory, not shown) of the APD device 330 by the patient or by the facility professional 18 via a user interface 334. Alternatively, the facility professional remotely and wirelessly enters the prescribed fill volume into the control unit (processor and memory) of the APD device 330 via the facility professional's laptop computer, tablet, or computer / tablet hybrid.

[0212]

[0236] For a single exchange, the prescribed fill from fill bag 314 is pumped to patient 16, after which the patient can disconnect machine 330 and leave facility 100. For multiple fills, the patient can remain connected to machine 330 or disconnect from machine 330, remaining in physical proximity to machine 330 (e.g., within 30 minutes of the machine) while allowing the solution from fill bag 314 to pool in the patient's peritoneum to remove toxins and ultrafiltrate ("UF"). After the prescribed dwell period has expired, machine 330 automatically draws spent effluent dialysate from the patient into and through a disposable pumping cassette, which then pumps the effluent dialysate for discharge via drain line 316.

[0213]

[0237] The disposable set 312 may therefore include one or more additional supply bags 322 so that the drain and fill procedures can be repeated one or more times. The device 330 records all fill and drain volumes for logging and delivery to the patient's clinic 22a-22c via any of the data flow methods described herein. The one or more additional supply bags 322 may contain a different type of dialysate than the initial fill bag 314. For example, the final fill supply bag 322 may contain dialysate prescribed to be left in the patient's peritoneum after the patient leaves the facility 100.

[0214]

[0238] Referring now to FIG. 13, one embodiment of the CAPD peritoneal dialysis treatment area 400 discussed above is shown. The CAPD peritoneal dialysis treatment area 400 similarly dispenses a prescribed type of dialysis solution in a specified volume and may be part of the treatment facility 100 discussed above. The treatment area 400 includes CAPD treatment stations 410a-410d, each of which provides a disposable set 412 that is typically manually operated by the patient. Each disposable set 412 may contain a different dialysis solution, for example, having a different dextrose level (e.g., 1.5%, 2.5%, and 4.25% dextrose) or glucose level (e.g., 1.36%, 2.27%, and 3.86% glucose), at known and approved levels. Each disposable set 412 may also contain a specified volume of the prescribed type of dialysis solution. Alternatively, the disposable set 412 may contain more dialysate than the prescribed volume and rely on the patient to measure out the prescribed volume of dialysate.

[0215]

[0239] In the illustrated embodiment, the disposable set 412 is a twin-bag CAPD set that uses three clamps 414a, 414b, and 414c to administer CAPD therapy. Clamp 414a is attached to a first tube 416, which is connected to the patient's transfer set 242 (FIG. 11), which in turn runs to a catheter implanted in the patient's body. Clamp 414b is attached to a second tube 418, which is connected at one end to a Y-joint 420 that is joined to the other end of the first tube 416. The second tube 418 is connected at its other end to a dialysis fluid bag or container 422 to deliver the prescribed amount and type of dialysate to the patient. Clamp 414b is attached to a third tube 424, which is connected at one end to a drain bag 426 to collect and discard the patient's spent effluent dialysate.

[0216]

[0240] When the patient first fills with spent effluent, the patient opens valves 414a and 414c, allowing gravity drain into drain bag 426. To flush the system of drain fluid, the patient then opens valves 414b and 414c, allowing gravity flow of a small amount of fresh fluid to the drain, flushing and priming second tubing 418. The patient then refills with fresh dialysate by opening valves 414a and 414b to allow a gravity feed of fresh fluid to the patient. Disposable set 412 can alternatively replace the separate valves 414a-414c with a single multi-position valve that connects to wye joint 420 and provides multiple positions for manual settings to perform each of the drain, flush, and fill steps.

[0217]

[0241] Multiple disposable sets 412 may be provided to the patient for multiple exchanges. In either case, the patient may alternatively drain to the common drain area 250 or to an individual house drain, including all of the alternatives already discussed above in connection with Figures 10 and 11. When the patient drains to the common drain area 250 or to a house drain, the disposable set 412 requires only a single line 416 connected at the patient end of valve 414a and at the other end to the solution bag 422. The single line 416 may be packaged pre-primed to valve 414a to eliminate the need for a flushing step. As with the APD set 312, the solution bag 422 of the CAPD set 412 may be pre-warmed in the storage room 150 to or near the patient's body temperature (e.g., approximately 37°C) to reduce or eliminate the heating time before patient filling can begin.

[0218]

[0242] For a single exchange, the prescribed fill from the fill bag 422 is gravity-fed to the patient 16, after which the patient can detach the set 412 and leave the facility 100. For multiple fills, the patient remains in physical proximity to the facility 100 (e.g., within 30 minutes of the facility) while the solution from the fill bag 422 is allowed to pool in the patient's peritoneum, removing toxins and ultrafiltrate ("UF"). After the prescribed dwell period is over, the patient drains the drain bag 426 using the second disposable set 412 into the community drain 250 or another house drain as discussed above, and performs another fill with the second supply bag 422.

[0219]

[0243] Facility 100 records all fill and drain volumes via any data flow method described herein for logging and delivery to patient clinics 22a-22c. One or more additional supply bags 422 may contain a different type of dialysate than the initial fill bag 422. For example, the final fill supply bag 422 may contain dialysate prescribed to remain in the patient's peritoneum after the patient leaves facility 100.

[0220] Facility System Architecture

[0244] Figures 14 and 15 illustrate various embodiments for integrating the facilities described above into a larger system. Also illustrated are various methods for operating the facilities of the present disclosure. In Figure 14, peritoneal dialysis system 10 includes peritoneal dialysis exchange facilities 100a, 100b, and 100c, which have access to electronic medical record databases 522a, 522b, and 522c via system hub 520 and web portal 560. In Figure 15, peritoneal dialysis system 110 includes peritoneal dialysis exchange facilities 100a, 100b, and 100c, which have access to electronic medical record databases 522a, 522b, and 522c via web portal 524. The primary difference between the two systems is that in system 10 of Figure 14, web portal 560, accessed via dialysis exchange facilities 100a, 100b, and 100c, is provided by the same entity that provides and supports the patient's home equipment, e.g., a supplier of equipment, solutions, and disposables ("equipment supplier"). Here, facilities 100a, 100b, and 100c are primarily owned and operated by the device provider. In contrast, in system 110 of FIG. 15 , web portal 524 is hosted by a different entity (e.g., by one of the clinics working with the device provider). There may be multiple different entities or clinics operating in system 110, each hosting its own web portal 524. For example, Clinic A working with a device provider may serve the portion of a country in which the device provider operates, while Clinic B working with the device provider serves another portion of the country, and so on. Here, facilities 100a, 100b, and 100c may be primarily owned and operated by a clinic or company other than the device provider.

[0221]

[0245] In systems 10 and 110, exchange facilities 100a, 100b, and 100c are walk-in facilities where peritoneal dialysis patients can receive peritoneal dialysis treatment at their location. In some embodiments, each facility 100 receives prescriptions from patients and verifies that the patient has been prescribed peritoneal dialysis treatment by an authorized physician. In one embodiment, frequent patients can have their prescriptions stored in the facility's computer so that they can be identified, accessed from a database, and administered without the patient having to bring their prescription to the facility. The patient's prescription specifies several treatment parameters, such as the type of treatment (e.g., APD vs. CAPD), the number of exchanges per treatment, and the volume and type of solution for each exchange. Different dialysis solutions contain dextrose or glucose, salts, and other components in different compositions. The glucose or dextrose controls the osmotic gradient provided by the dialysate, which in turn controls how much and how quickly excess fluid is withdrawn from the patient's body as ultrafiltrate ("UF") and drawn into the peritoneum. The higher the dextrose level, the greater the UF capacity of the solution, but the higher the caloric intake of the solution. Patients may require more or less glucose or dextrose for longer dwell time exchanges, such as daytime exchanges. Electrolytes, such as potassium and calcium, are also often included in dialysis solutions at concentrations similar to those found in healthy blood. The composition of the dialysis solution and the amount of dialysis solution used per exchange are therefore prescribed by a licensed physician to optimally treat each individual patient.

[0222]

[0246] This disclosure contemplates various devices and methods for receiving and reviewing patient prescriptions. In the embodiments discussed herein, a patient may present to exchange facility 100 (generally referred to as each facility 100a, 100b, 100c...100n, or collectively referred to as all facilities) with a paper prescription or an electronic file or data storage device (e.g., flash drive) provided to the patient by an authorized physician from an external hospital or clinic. Facility 100 can then review the prescription via web portal 560 (FIG. 14) or 524 (FIG. 15) by accessing electronic medical record ("EMR") databases 522a, 522b, and / or 522c through the web portal. Physician or clinician databases 522a, 522b, and 522c store data related to each patient's current dialysis prescription and may additionally maintain historical information, such as past treatment data and past treatment prescriptions, none, some, or all of which may be accessible via facility 100. Thus, databases 522a, 522b, and 522c may simply review (manually or automatically) the patient's prescription order for a match to one or more current prescription orders and communicate back to facility 100 whether a match was found. Otherwise, databases 522a, 522b, and 522c may display the patient's approved prescription order(s) to professional staff at facility 100 for review.

[0223]

[0247] Databases 522a, 522b, and 522c may additionally allow facility professional staff 18 to access designated treatment data for a patient. For example, a patient may have multiple approved prescriptions and the freedom to select any prescription to use on a given day. Patient data may indicate that one prescription may perform better than one or more other prescriptions. Facility professional staff 18 is trained to view such data and recommend one or more treatments that will result in better performance for the patient on that day.

[0224]

[0248] It is further contemplated that the patient will not be required to bring the patient prescription order to facility 100. Instead, the patient name and / or patient identifier is entered at facility 100, which communicates with databases 522a, 522b, and 522c through web portal 524 or 560, which then transmits back the patient's currently approved prescription order(s), if any, where verification is present but no matching is required.

[0225]

[0249] If the patient cannot be found on database 522a, 522b, or 522c, it is contemplated that the site professional 18 will contact the patient's physician or clinician to obtain authorization to perform the exchange. Also, as discussed above, certain countries or regions within countries may not have the ability to link to systems for validation. Accordingly, it is contemplated that prescriptions brought in on paper or electronically may be self-certified so that an exchange can be performed as long as the prescription appears to be valid. Again, when the patient first visits the site 100, the patient and their current prescriptions may be entered into the site site 100 computer so that validation can be performed the next time the patient returns to the site 100. If the patient's prescriptions change, the changes may be noted on the site site 100 computer.

[0226]

[0250] As discussed in more detail below, after a prescription is validated or self-authenticated according to any of the embodiments discussed above, the prescription is used to determine the volume and type of dialysis solution the patient needs for their current treatment. The prescription also indicates whether the dialysis solution should be delivered to the patient via a machine or manually. Knowing this information allows the patient to take the next step toward obtaining their treatment.

[0227]

[0251] In the illustrated embodiment, a system hub 520 is connected to a connectivity server 530, a service portal 540, and web portals 560 and / or 524. The system hub 520 communicates with the patient's home peritoneal dialysis or APD device 550 through the connectivity server 530 to download new treatment prescriptions to the home device 550 and to receive current treatment data from the home APD device 550. In the illustrated embodiment, the device 550 is a hub for peritoneal dialysis peripherals located in the patient's home (dotted lines 14 and 15), which may include a user interface such as a modem 552, a blood pressure monitor 554, a meter 556, and a wireless tablet user interface 558. The modem 552, blood pressure monitor 554, meter 556, and tablet 558 may communicate wirelessly with the home APD device 550 or, alternatively, may be wired to the home device 550.

[0228]

[0252] Modem 552 may be a 3G, 4G, 5G, or other type of internet modem to enable communication between home device 550 and system hub 520. Blood pressure monitor 554 and scale 556 may acquire and record the patient's blood pressure and weight. Similarly, blood pressure monitor 554 may be a pneumatic blood pressure cuff that is pressurized around the patient's arm. Blood pressure monitor 554 may transmit blood pressure data to the control processor of home device 550, or the patient may measure their own blood pressure and enter the data into tablet 558, which then transmits the blood pressure data to the control processor of home device 550. The control processor of home APD device 550 may use weight data from scale 556 to calculate, for example, how much ultrafiltrate was removed from the patient after therapy. The therapy data is stored and later transferred via modem 552 to electronic medical record databases 522a-522c for use in evaluating current therapy prescriptions and determining new prescriptions.

[0229]

[0253] In addition to storing weight and blood pressure data, each home peritoneal dialysis treatment performed by a patient using the home device 550 will store parameters and data related to the movement of the home device 550 and the patient throughout the treatment. The device 550 may store, for example, dialysis fluid flow rate and the total amount of ultrafiltrate removed throughout the treatment. Errors, alerts, alarm conditions, and whether treatment steps were successfully performed may also be recorded. The treatment data is then transmitted from the home device 550 via modem 552 to the system hub 520 via connectivity server 530, where it is stored in a hospital or clinician database 522a, 522b, or 522c, which may then be accessed by facility 100a, 100b, or 100c, as discussed above.

[0230]

[0254] The physician and clinician databases 522a, 522b, and 522c contain patient-specific treatment and prescription data, and therefore access to the databases may be strictly restricted. In each of the embodiments shown in Figures 14 and 15, the facilities 100a, 100b, and 100c may be able to obtain some level of access to the physician or clinician databases 522a, 522b, and 522c through a web portal. In Figure 14, the facilities 100a, 100b, and 100c and the patients and clinicians 562a, 562b, and 562c, respectively, access a web portal 560 hosted by the device provider, for example, from their home computers. The physicians / clinicians will have access to data not available to patients or the general public. The facilities 100a, 100b, and 100c may have physician / clinician-level access, general public-level access, or some level of access in between. In Figure 15, the same level of access to the patient database may be provided to facilities 100a, 100b, and 100c via physician / clinician internet portal 524 as provided by device provider portal 560 in Figure 14. Again in Figure 15, physician / clinician portal 524 and facilities 100a, 100b, and 100c are controlled and / or owned by clinics or hospitals, as opposed to Figure 14, where portal 560 and facilities 100a, 100b, and 100c are controlled and / or owned by device providers.

[0231]

[0255] Referring again to both FIGS. 14 and 15 , the system hub 520 and the connectivity server 530 are also connected to the service portal 540. The connectivity server 530 allows the service personnel director 542 and service personnel 544a, 544b, and 544c to track and retrieve various assets throughout the network using the serial numbers of the home devices 550 and / or modems. These assets may include APD devices and / or other devices located within the facilities 100a, 100b, and 100c. The connectivity server 530 may also be used to receive and provide firmware upgrades to APD devices located in patients' homes or in-center APD devices located within the facilities 100a, 100b, and 100c. APD devices and / or other devices located anywhere in the systems 10, 110, including within the facilities 100a, 100b, and 100c, may be operated in a service mode to allow service personnel to access, diagnose, and troubleshoot on-site and / or remotely. Service technicians can also remotely examine and retrieve data files stored on APD devices and / or other devices located anywhere in the system 10, 110, including within the facilities 100a, 100b, and 100c, to determine the cause of device errors.

[0232]

[0256] While systems 10 and 110 assume that patients have home dialysis machines 550 and internet access to portals 524 and 560, it is contemplated that the present disclosure may be used in developing countries and other areas where people need access to renal therapy but do not have access to or the means for home APD machines 550 or the internet. Systems 10 and 110 therefore also include and support walk-up patients located in areas that do not have home dialysis machines, service personnel support, system hub support, or access to a web portal, where facility 100 instead provides the computers and software for accepting and verifying customer and / or prescription orders.

[0233]

[0257] For example, if a patient shows up at facility 100 with a paper prescription, the facility can call the prescribing physician's hospital or clinic to verify the prescription provided by the patient. An authorized treating physician can also provide prescriptions prior to the patient's visit to the facility to directly contact facility 100 on the patient's behalf and facilitate treatment. If the prescription is written by a hospital or clinic associated with facility 100, the facility may already have access to the patient's records upon the patient's arrival at the facility. Those skilled in the art will recognize additional methods of receiving patient prescriptions that may be available to facilities (e.g., facilities in developed countries) in accordance with the present disclosure.

[0234]

[0258] In some cases, such as when a prescription is provided directly to the facility by an authorized physician or when the prescription is filled by a hospital or clinic associated with the facility, the facility may be able to validate the prescription upon receipt. In other cases, such as when a patient self-prescribes the prescription at the facility 100, the validation process occurs after the prescription is received by the facility. In the case of a frequent patient of the facility, the facility may maintain the patient's prescription on file, either electronically or on paper, and allow the patient to retrieve the prescription each time they enter the facility for treatment after the prescription has been validated during their initial visit.

[0235]

[0259] After the facility 100 has verified the patient's prescription, the facility knows the type and amount of dialysis solution, as well as any disposable items required for this purpose. Each facility 100 therefore stocks a variety of peritoneal dialysis solutions and associated disposables with varying compound concentrations to meet the needs of different patients with different residual kidney function and toxin export characteristics. Dispensing the specified amount of dialysis solution prescribed for each patient can be accomplished in several ways, some of which are described below.

[0236] Additional Aspects of the Disclosure

[0260] Aspects of the subject matter described herein may be useful alone or in combination with any one or more of the other aspects described herein. Without limiting the above, in a first aspect of the present disclosure, a method of treating a peritoneal dialysis patient includes providing a plurality of different peritoneal dialysis solutions to a single location, receiving a patient at the single location, receiving a prescription for the patient, selecting one of the peritoneal dialysis solutions based on the prescription, and allowing the patient to receive peritoneal dialysis treatment using the selected peritoneal dialysis solution.

[0237]

[0261] In a second aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects listed herein, the receiving step includes the substep of accepting prescription instructions.

[0238]

[0262] In a third aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects listed herein, the receiving step includes the substep of retrieving prescription instructions.

[0239]

[0263] In a fourth aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects listed herein, the receiving step includes the substep of confirming the prescription order.

[0240]

[0264] In a fifth aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects listed herein, the enabling step includes the substep of providing a peritoneal dialysis machine and cassette to the patient.

[0241]

[0265] In a sixth aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects listed herein, the enabling step includes the substep of providing a continuous ambulatory peritoneal dialysis set and / or catheter.

[0242]

[0266] In a seventh aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects listed herein, the enabling step includes a substep of providing access to a multi-therapy container of selected peritoneal dialysis solution.

[0243]

[0267] In an eighth aspect of the present disclosure, which may be used in combination with the seventh aspect or any other aspect or combination of aspects listed herein, the enabling step includes a substep of metering an amount of the selected peritoneal dialysis solution for the patient specified by the prescription.

[0244]

[0268] In a ninth aspect of the present disclosure, which may be used in combination with the eighth aspect, any other aspect, or combination of aspects listed herein, the selected peritoneal dialysis solution is provided in a container and in a volume according to the patient.

[0245]

[0269] In a tenth aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects listed herein, the enabling step includes a substep of enabling the patient to manually drain the spent dialysis fluid.

[0246]

[0270] In an eleventh aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects listed herein, a method for enabling peritoneal dialysis for multiple people at a single location includes the steps of preparing multiple dialysis solutions of various concentrations at a single location, accepting people who are peritoneal dialysis patients at a clinic or hospital different from the location, and matching the patients to one of the peritoneal dialysis solutions, where the patients can then use the matched peritoneal dialysis solution in their peritoneal dialysis treatment.

[0247]

[0271] In a twelfth aspect of the present disclosure, which may be used in combination with the eleventh aspect or any other aspect or combination of aspects listed herein, the patient is identified by accessing information provided by a clinic or hospital.

[0248]

[0272] In a thirteenth aspect of the present disclosure, which may be used in combination with the eleventh aspect, any other aspect, or a combination of aspects listed herein, the peritoneal dialysis solution is matched based on prescription instructions provided by a clinic or hospital.

[0249]

[0273] In a fourteenth aspect of the present disclosure, which may be used in combination with the eleventh aspect, any other aspect, or a combination of aspects listed herein, the step of accepting a patient includes the substeps of inputting information provided by the patient and obtaining a matched peritoneal dialysis solution based on the input information.

[0250]

[0274] In a fifteenth aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects listed herein, a method for enabling peritoneal dialysis self-treatment for multiple patients at a single location includes the steps of providing multiple peritoneal dialysis machines capable of dispensing dialysis solutions of various concentrations, and matching patients to dialysis solutions based on prescription instructions provided by the patients, wherein the patients may then use one of the peritoneal dialysis machines to perform peritoneal dialysis treatment.

[0251]

[0275] In a sixteenth aspect of the present disclosure, which may be used in combination with the fifteenth aspect or any other aspect or combination of aspects listed herein, the prescription instructions are provided via a data storage device.

[0252]

[0276] In a seventeenth aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects listed herein, a facility for providing peritoneal dialysis exchanges for a plurality of peritoneal dialysis patients includes a plurality of peritoneal dialysis solutions of various concentrations and a system configured to accept information from the patient regarding a treatment prescribed for the patient, the treatment prescribing one of the dialysis solutions and the patient being able to perform a peritoneal dialysis exchange at the facility using the prescribed peritoneal dialysis solution.

[0253]

[0277] In an eighteenth aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects listed herein, a walk-in facility for peritoneal dialysis patients includes a plurality of peritoneal dialysis machines containing dialysis solutions of various concentrations, and a means for accepting and verifying prescriptions from patients, which can be matched to dialysis solutions and which allow patients to perform self-treatment at the facility.

[0254]

[0278] In a nineteenth aspect of the present disclosure, which may be used in combination with the eighteenth aspect or any other aspect or combination of aspects listed herein, the treatment is prescribed by a hospital or clinic associated with the facility.

[0255]

[0279] In a twentieth aspect of the present disclosure, which may be used in combination with the eighteenth aspect or any other aspect or combination of aspects listed herein, the treatment is prescribed by a hospital or clinic under different ownership than the facility.

[0256]

[0280] In a twenty-first aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects listed herein, a peritoneal dialysis system includes a reusable filling container, a reusable drain container, and a reusable continuous ambulatory peritoneal dialysis ("CAPD") set constructed and arranged to be fluidly connected to at least one of the reusable filling container or the reusable drain container.

[0257]

[0281] In a twenty-second aspect of the present disclosure, which may be used in combination with the twenty-first aspect or any other aspect or combination of aspects listed herein, the reusable filling container and the reusable drain container are configured to be combined together into a single unit for hand carrying.

[0258]

[0282] In a 23rd aspect of the present disclosure, which may be used in combination with the 21st aspect or any other aspect or combination of aspects listed herein, at least one of the reusable filling container and the reusable drain container is rigid or semi-rigid.

[0259]

[0283] In a 24th aspect of the present disclosure, which may be used in combination with the 21st aspect or any other aspect or combination of aspects listed herein, the reusable filling container or the reusable drain container includes a handle for carrying the container by hand when combined together to form a single unit.

[0260]

[0284] In a twenty-fifth aspect of the present disclosure, which may be used in combination with the twenty-first aspect or any other aspect or combination of aspects listed herein, the reusable filling container is labeled with the prescribed type of peritoneal dialysis ("PD") solution.

[0261]

[0285] In a 26th aspect of the present disclosure, which may be used in combination with the 21st aspect or any other aspect or combination of aspects listed herein, a reusable filling container is filled with a prescribed type of peritoneal dialysis ("PD") solution.

[0262]

[0286] In a 27th aspect of the present disclosure, which may be used in combination with the 26th aspect or any other aspect or combination of aspects listed herein, the system includes a patient treatment facility, and the reusable filling container is configured to be filled with a prescribed PD solution at a location remote from the patient treatment facility.

[0263]

[0287] In a 28th aspect of the present disclosure, which may be used in combination with the 26th aspect or any other aspect or combination of aspects listed herein, the system includes a patient treatment facility, and the reusable filling container is configured to be filled with a prescribed PD solution at the patient treatment facility.

[0264]

[0288] In a 29th aspect of the present disclosure, which may be used in combination with the 28th aspect or any other aspect or combination of aspects listed herein, the system is configured to prepare the PD solution at a treatment facility before the reusable filling container is filled with the PD solution.

[0265]

[0289] In a thirtieth aspect of the present disclosure, which may be used in combination with the twenty-eighth aspect or any other aspect or combination of aspects listed herein, a reusable filling container is first provided with a concentrate, which is then mixed with purified water at a treatment facility.

[0266]

[0290] In a thirty-first aspect of the present disclosure, which may be used in combination with the twenty-eighth aspect or any other aspect or combination of aspects listed herein, the system is configured such that the filling container and PD solution undergo a sterilization procedure at a patient treatment facility prior to delivery of the container and solution to the patient.

[0267]

[0291] In a 32nd aspect of the present disclosure, which may be used in combination with the 28th aspect or any other aspect or combination of aspects listed herein, the system includes a sterilization device at a patient treatment point in a patient treatment facility, and the filling container and PD solution are subjected to the sterilization device after delivery of the container and solution to the patient.

[0268]

[0292] In a thirty-third aspect of the present disclosure, which may be used in combination with the twenty-first aspect or any other aspect or combination of aspects listed herein, a reusable filling container includes a valve-controlled injection spout.

[0269]

[0293] In a thirty-fourth aspect of the present disclosure, which may be used in combination with the twenty-first aspect or any other aspect or combination of aspects listed herein, a reusable CAPD set is provided in a pouch, and the fill or drain container includes a structure for releasably holding the pouch.

[0270]

[0294] In a thirty-fifth aspect of the present disclosure, which may be used in combination with the thirty-fourth aspect or any other aspect or combination of aspects listed herein, the pouch is resealable.

[0271]

[0295] In a thirty-sixth aspect of the present disclosure, which may be used in combination with the twenty-first aspect or any other aspect or combination of aspects listed herein, a reusable CAPD set is provided in a pouch and includes a replacement patient transfer set cap provided in the pouch.

[0272]

[0296] In a thirty-seventh aspect of the present disclosure, which may be used in combination with the twenty-first aspect or any other aspect or combination of aspects listed herein, a reusable CAPD set includes a fill line and a drain line in fluid communication with a patient line.

[0273]

[0297] In a thirty-eighth aspect of the present disclosure, which may be used in combination with the twenty-first aspect or any other aspect or combination of aspects listed herein, the CAPD set includes a manual valve operable by a user to switch from a drain mode to a flush mode to a fill mode.

[0274]

[0298] In a thirty-ninth aspect of the present disclosure, which may be used in combination with the twenty-first aspect or any other aspect or combination of aspects listed herein, the system is configured such that three caps from a CAPD set, one cap from the filling container, one cap from the drain container, and one cap from the pouch, are subjected to a sterilization process after treatment.

[0275]

[0299] In a fortieth aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects listed herein, a peritoneal dialysis system includes a reusable filling container and a reusable drain container, the reusable filling container and the reusable drain container configured to be combined together into a single unit for hand carrying.

[0276]

[0300] In a forty-first aspect of the present disclosure, which may be used in combination with the fortieth aspect or any other aspect or combination of aspects listed herein, the disposable CAPD set is (i) provided in the form of a disposable pouch that undergoes a sterilization process, and / or (ii) configured and arranged to be fluidly connected to at least one of a reusable filling container or a reusable drain container.

[0277]

[0301] In a forty-second aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects listed herein, a peritoneal dialysis system includes a filling container and an actuation unit that removably receives the filling container, the actuation unit including a sterilization source configured and arranged to place fluid in the filling container in a physiologically safe state for delivery to a patient's peritoneal cavity when received by the actuation unit relative to the filling container.

[0278]

[0302] In a forty-third aspect of the present disclosure, which may be used in combination with the forty-second aspect or any other aspect or combination of aspects listed herein, the fluid is water or dialysate.

[0279]

[0303] In a forty-fourth aspect of the present disclosure, which may be used in combination with the forty-second aspect or any other aspect or combination of aspects listed herein, the fluid is water and includes a packet of additives that, when mixed with the water, forms a dialysis solution suitable for delivery to a patient's peritoneal cavity.

[0280]

[0304] In a forty-fifth aspect of the present disclosure, which may be used in combination with the forty-fourth aspect or any other aspect or combination of aspects listed herein, the filling container comprises an opening for receiving the additive from the packet.

[0281]

[0305] In a 46th aspect of the present disclosure, which may be used in combination with the 42nd aspect or any other aspect or combination of aspects listed herein, the sterilization source includes a plurality of ultraviolet ("UV") lights.

[0282]

[0306] In a 47th aspect of the present disclosure, which may be used in combination with the 42nd aspect or any other aspect or combination of aspects listed herein, the sterilization source includes a plurality of panels positioned adjacent to multiple sides of the filling container when received by the actuation unit.

[0283]

[0307] In a 48th aspect of the present disclosure, which may be used in combination with the 42nd aspect or any other aspect or combination of aspects listed herein, the actuation unit includes a measuring device for measuring how much fluid has been delivered to the container.

[0284]

[0308] In a forty-ninth aspect of the present disclosure, which may be used in combination with the forty-eighth aspect or any other aspect or combination of aspects listed herein, the metering device includes a meter.

[0285]

[0309] In a 50th aspect of the present disclosure, which may be used in combination with the 42nd aspect or any other aspect or combination of aspects listed herein, the actuation unit includes a heater positioned and arranged to heat the fluid in the filling container when received by the actuation unit.

[0286]

[0310] In a 51st aspect of the present disclosure, which may be used in combination with the 42nd aspect or any other aspect or combination of aspects listed herein, the peritoneal dialysis system includes at least one valve operably connected to an actuation unit so as to be selectively operable with at least one of the inlet or outlet of the filling container.

[0287]

[0311] In a 52nd aspect of the present disclosure, which may be used in combination with the 51st aspect or any other aspect or combination of aspects listed herein, the filling container includes an inlet tube and an outlet tube, and at least one valve includes a filling valve operable with the inlet tube and a dispensing valve operable with the outlet tube.

[0288]

[0312] In a 53rd aspect of the present disclosure, which may be used in combination with the 42nd aspect or any other aspect or combination of aspects listed herein, the actuation unit includes a control unit and at least one sensor that provides feedback to the control unit.

[0289]

[0313] In a 54th aspect of the present disclosure, which may be used in combination with the 53rd aspect or any other aspect or combination of aspects listed herein, at least one sensor is removably coupled to the filling container.

[0290]

[0314] In a 55th aspect of the present disclosure, which may be used in combination with the 42nd aspect or any other aspect or combination of aspects listed herein, the peritoneal dialysis system includes a sterile unit separate from the operating unit, the sterile unit being sized to receive a peritoneal dialysis set and configured to place the set in a physiologically safe condition for delivering fluid to a patient's peritoneal cavity.

[0291]

[0315] In a 56th aspect of the present disclosure, which may be used in combination with the 55th aspect or any other aspect or combination of aspects listed herein, the sterilization unit used ultraviolet ("UV") radiation to place the peritoneal dialysis set in a physiologically safe condition.

[0292]

[0316] In a 57th aspect of the present disclosure, which may be used in combination with the 55th aspect or any other aspect or combination of aspects listed herein, the peritoneal dialysis system includes a disinfection unit separate from the operating unit and the sterilization unit, the disinfection unit configured to disinfect the peritoneal dialysis set before placing the peritoneal dialysis set in a physiologically safe state using the sterilization unit.

[0293]

[0317] In a fifty-eighth aspect of the present disclosure, which may be used in combination with the fifty-seventh aspect or any other aspect or combination of aspects listed herein, the disinfection unit is a hot water disinfection unit.

[0294]

[0318] In a fifty-ninth aspect of the present disclosure, which may be used in combination with the forty-second aspect or any other aspect or combination of aspects listed herein, the peritoneal dialysis system includes a fluid purification unit separate from the actuation unit for purifying the fluid before using the actuation unit to place the fluid in a physiologically safe state.

[0295]

[0319] In a sixtieth aspect of the present disclosure, which may be used in combination with the fifty-ninth aspect or any other aspect or combination of aspects listed herein, the fluid purification unit uses at least one process selected from the group consisting of distillation, reverse osmosis, carbon filtration, ultraviolet ("UV") radiation, electrodeionization, ultrafiltration, or any combination thereof.

[0296]

[0320] In a sixty-first aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects listed herein, a peritoneal dialysis ("PD") method includes the steps of providing a patient with a dialysis additive packet, a disinfected PD set, and a drain container; providing, at a patient station, an operating unit containing a sterile unit and a filling container; allowing the patient to place the disinfected PD set into the sterile unit; placing the disinfected PD set in the sterile unit in a physiologically safe state for use with the patient; and allowing the patient to fill the contents of the additive packet with the filling container contained in the operating unit. filling the filling container with purified water and mixing the additive contents with the purified water to form PD dialysate; allowing the patient to drain the effluent fluid into a drain container using a physiologically safe PD set; heating and sterilizing the PD dialysate to form physiologically safe and properly heated dialysate; and when the effluent drainage is complete and the dialysate is physiologically safe and properly heated, filling the patient with the physiologically safe and properly heated dialysate from the filling container through the PD set.

[0297]

[0321] In a 62nd aspect of the present disclosure, which may be used in combination with the 61st aspect or any other aspect or combination of aspects listed herein, the PD method includes a step of metering the amount of effluent fluid discharged into a drain container.

[0298]

[0322] In a 63rd aspect of the present disclosure, which may be used in combination with the 62nd aspect or any other aspect or combination of aspects listed herein, a PD method includes the steps of metering an amount of physiologically safe and appropriately heated dialysis fluid delivered to a patient and subtracting this delivered amount from the discharged amount to measure the amount of ultrafiltration ("UF") removed from the patient.

[0299]

[0323] In a 64th aspect of the present disclosure, which may be used in combination with the 61st aspect or any other aspect or combination of aspects listed herein, the PD method includes a step of allowing a patient to return a used PD set and a filled drain container for recycling.

[0300]

[0324] In a 65th aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects listed herein, a peritoneal dialysis ("PD") system includes a peritoneal dialysis set provided to a patient, a disinfection unit configured to disinfect the peritoneal dialysis set before providing the peritoneal dialysis set to the patient, a sterilization unit sized to receive the peritoneal dialysis set and configured to place the peritoneal dialysis set in a physiologically safe state for delivery of fluid to the patient's peritoneal cavity, a filling container, and an actuation unit that removably receives the filling container, the actuation unit including a sterilization source configured and arranged to place fluid in the filling container in a physiologically safe state for delivery to the patient's peritoneal cavity when received by the actuation unit relative to the filling container.

[0301]

[0325] In a sixty-sixth aspect of the present disclosure, which may be used in combination with the sixty-fifth aspect or any other aspect or combination of aspects listed herein, the system is provided within a single facility.

[0302]

[0326] In a 67th aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects listed herein, a peritoneal dialysis ("PD") method includes the steps of providing a patient with a reusable filling container, a reusable drain container, and a reusable continuous ambulatory peritoneal dialysis ("CAPD") set; enabling the patient to perform CAPD therapy using the filling container, the drain container, and the CAPD set; receiving the filling container, the drain container, and the CAPD set from the patient after CAPD therapy; and regenerating the filling container, the drain container, and the CAPD set for use in a subsequent CAPD therapy.

[0303]

[0327] In a sixty-eighth aspect of the present disclosure, any of the structures and functions shown and described in connection with Figures 1-15 may be used in combination with any one or more or all of the above aspects.

Claims

[Claim 1] The invention described in the specification.

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