KR20020008145A - Method, apparatus and components of dialysis systems - Google Patents

Abstract

An apparatus 100 for preparing a peritoneal dialysis fluid includes a water preparation module 200 that purifies tap water and supplies the purified water to a thermal control and sterilization module 300. The thermal control and sterilization module 300 sends the purified water to a concentrate mixing module 400 which mixes the purified water with the concentrated components of the dialysis fluid exiting the disposable concentrate chamber 402 To produce a peritoneal dialysis fluid. At least some components of the concentrated component of the dialysis fluid are in powdered form. The peritoneal dialysis fluid is passed from the concentrate mixing chamber 400 to the thermal control and sterilization module 300 which is sterilized in an on-line autoclave before being sent to the cycler and sterilizable connector module 600 to be introduced into the patient 50 It is sent again. The device according to the present invention is such that the peritoneal dialysis fluid is prepared online for a particular prescription to the patient at the treatment site, such as the patient's bedroom.

Description

[0001] METHOD AND APPARATUS AND COMPONENTS OF DIALYSIS SYSTEMS [0002]

Renal insufficiency is a serious and life-threatening condition in which mammalian kidneys do not function properly to remove impurities, remove excess water, and perform other physiologically important functions. People with renal insufficiency need to be regularly dialyzed to clear blood and remove water.

In PD, which is one type of conventional dialysis process, PD fluid is introduced into the peritoneal cavity of a mammalian patient to stay in the peritoneal cavity, and then removed as spent dialysate (dialysate) do. Waste is transferred to the PD fluid and removed together with the spent dialysate. The osmotic agent in the PD fluid removes the excess. The buffer in the PD fluid replenishes the body buffer. Other electrolytes are balanced by the PD fluid.

Since PD fluid passes through the patient's body, there is often the risk of infection that also causes peritonitis.

To perform peritoneal dialysis, coupling is used to connect a catheter terminated in the confined membrane cavity to the PD fluid source. In an attempt to reduce the infection of the patient, such coupling is made as a " aseptic or sterile " coupling. Although the aseptic coupling helps to reduce contamination of the PD fluid, each coupling allows potentially harmful microorganisms, such as bacteria and fungi, to enter other aseptic PD systems, Lt; / RTI > Decreasing the number of these couplings may reduce the risk of infection and peritonitis.

Traditionally, aseptic PD fluid is stored in a plastic fluid bag and injected into the patient. Aseptic coupling is typically used to connect the fluid bag to the patient's catheter. Each coupling increases the likelihood of bacteria and other contamination.

The two most common types of PD, continuous ambulatory peritoneal dialysis (CAPD) and automatic peritoneal dialysis (APD), require the use of many fluid bags per year. CAPD relies on normal gravity to fill and drain (drain) PD fluids from the back set, and is continuously treated while the patient is still moving relatively freely. Fluid exchange is usually done during the day . The APD typically relies on the use of a cycler to pump the PD fluid from the fluid bag to perform a filling and dispensing cycle to the patient while the patient is sleeping during the night. In both cases, a specially formulated PD fluid is produced under sterile conditions in a manufacturing plant and packaged in one or more bags, which are then sent to the patient or physician.

However, there are many drawbacks and drawbacks to using a PD fluid bag. Different patients have different dialysis conditions, these conditions may vary from time to time, and therefore the benefits of using PD fluids that individually meet the needs of the patient can be achieved. As a result, manufacturers of PD fluids must manufacture and deliver many different PD fluid formulations. This makes it necessary to provide a repository in the patient's home, often storing a considerable number of bags containing different PD fluid formulations.

Today, clinical trials are being conducted using bicarbonate as a buffer instead of conventional lactate buffered PD fluids. Conventional PD fluids have relatively low pH, which may cause discomfort and even pain during the filling step. By using bicarbonate as a buffer, a PD fluid having a physiological pH may be prepared (prescription). However, over time, calcium carbonate formed from the components of the PD fluid may precipitate from the PD fluid solution and render the solution unusable.

Glucose, another component of the PD fluid, may deteriorate over time, especially when the PD fluid is heat sterilisated in a conventional manner in an autoclave. Degradation of glucose may result in degradation products that are potentially harmful to the patient, at least over a prolonged period of time.

The PD fluid bag is often carried over a considerable distance from the point of manufacture to the point of use. Because a large portion of the PD fluid is water, it is actually a large amount of water carried from the PD fluid production plant to a treatment point, such as a hospital, clinic, or patient's home.

In addition, the PD fluid bag is limited in size because it must be light enough for the patient or physician to handle it easily. Most PD fluid bags for CAPD contain a relatively small amount of fluid, such as from 0.5 liters to 5 liters. If greater capacity is required, such as in an APD, multiple PD fluid bags may be used during each treatment period. However, the use of more than one PD fluid bag requires aseptic coupling for each bag, and a relatively complex connection and disconnection process is required when changing bags. While this additional connection and disconnection process occurs in aseptic conditions, potentially harmful bacteria enter the dialysis system and provide the potential for peritonitis. The APD may include four or five connections.

For dialysis, specifically acute hemodialysis, a sterile dialysis solution bag is used. During hemofiltration and hemodialysis filtration, infusion solutions are used for infusion into the blood. These solutions have the same problems as described above.

U.S. Patent Nos. 4,718,890, 4,747,822, 5,004,459, and 5,643,201 propose to construct and administer a PD fluid at the treatment site. However, these proposed approaches have various problems and disadvantages. U.S. Patent No. 5,643,201 is an example. This patent discloses a system for preparing a PD fluid using a concentrated dialysate source as a starting point. In this system, water is purified in a reverse osmosis unit and then mixed with the liquid concentrate by means of a volumetric proportioning pump. Additional glucose solution may be added by the glucose pump. The mixed fluid is heated to a temperature of 70 ° C to 80 ° C and then cooled to a temperature suitable for the patient and transferred to a storage section, and the amount thereof is checked through gravity measurement of the storage section. Then, . Because such a system uses a concentrated solution as a PD fluid concentrate, if a bicarbonate buffer is used, for example, the stability of the concentrate may be problematic. In addition, the proposed temperature of 70 DEG C to 80 DEG C may be unsuitable for achieving a sufficiently high level of sterilization.

Also, although the optional glucose is added, the relative concentration of electrolyte components of the PD fluid is fixed by its relative concentration in its initially enriched form. Thus, even if the glucose concentration is separate, the basic formulation of the PD fluid is predetermined by the proportion of the constituent material of the initial concentrated dialysate source. To enable the system to be used according to different prescriptions, it may be necessary to provide a range of different concentrated dialysate sources each having a constituent material present in an appropriate proportion to such a prescription. Thus, a range of sources such as a bag of concentrated dialysate liquid may be required, which will cause the same logistic problem as in a PD treatment system in which the PD fluid is prepared entirely at the remote manufacturing site.

Other proposals for preparing medical aqueous solutions, including PD fluids, are disclosed in GB 1450030. This also uses a concentrated solution as the starting point. The relative concentration of the electrolyte is predetermined by the concentrated starting solution. This proposal in 1972 does not provide details on how PD fluid is delivered to the patient.

In light of the foregoing, there is a need in the art to improve peritoneal dialysis techniques.

This application is based on the benefit of the priority of Swedish Patent Application No. 9901165-2, filed on March 30, 1999, which application is incorporated herein by reference. Also, U. S. Patent Application Serial No. 60 / 127,179, filed March 30, 1999, is also incorporated herein by reference.

The present invention relates to methods, apparatus and components of a dialysis system such as a peritoneal dialysis system, a hemodialysis system, a hemodiafiltration system or a blood filtration system.

1 is a schematic partial perspective view of an apparatus for preparing a peritoneal dialysis fluid according to one embodiment of the present invention.

1A is a block diagram of a processor system in the apparatus shown in FIG.

Figure 2 is a schematic diagram showing the fluid path of the device of Figure 1 as an interconnected functional module.

Figure 3 is a detailed schematic diagram of the water preparation module shown in Figure 2;

Figure 4 is a detailed schematic diagram of the thermal control and sterilization module shown in Figure 2;

4A is a detailed schematic diagram illustrating another configuration of the thermal control and sterilization module shown in FIG.

5 is a detailed schematic diagram of the concentrate mixing module shown in FIG.

FIG. 5A is a detailed schematic diagram showing another configuration of the concentrate mixing module shown in FIG. 2. FIG.

FIG. 5B is a detailed schematic diagram showing another configuration of the concentrate mixing module shown in FIG. 5A. FIG.

FIG. 6 is a detailed schematic diagram of the drainage module shown in FIG. 2. FIG.

Figure 7 is a detailed schematic diagram of the cycler and sterilization connector module shown in Figure 2;

8 is a perspective view showing a first example of a heat exchanger for use in sterilizing a PD fluid according to the present invention.

9 is a perspective view showing a second example of a heat exchanger for use in sterilizing PD fluid according to the present invention.

10 is a perspective view of a disposable concentrate container in accordance with the present invention.

Figure 11 is a partial cross-sectional view of the disposable concentrate container of Figure 10 with the vertical chassis portion removed.

12A to 12C are perspective views showing a part of the disposable concentrate container shown in Fig.

13 is a perspective view showing the compartments of the disposable concentrate container shown in Fig.

14 is a perspective view showing another compartment of the disposable concentrate container shown in Fig.

Figure 15 is a cross-sectional view of the disposable concentrate vessel during installation in the apparatus of the present invention.

16 is another cross-sectional view illustrating the disposable concentrate container during installation in the apparatus of the present invention.

17 is a cross-sectional view of the disposable concentrate container in place of the apparatus of the present invention.

18 is another cross-sectional view of the disposable concentrate container.

19A-19D are schematic diagrams of a sterilizable connector of the device of the present invention.

20 is a schematic diagram of a disposable fluid line for use with the apparatus of the present invention.

21 is a schematic diagram of a disposable sampling fluid line for use with the apparatus of the present invention.

22 is a detailed partial cross-sectional view showing the compartments of the disposable concentrate container shown in Fig.

Figure 23 is a cross-sectional view of the glucose compartment of the disposable concentrate container shown in Figure 10;

24 is a cross-sectional view of the lactic acid compartment of the disposable concentrate container shown in Fig.

Figure 25 is a cross-sectional view of the lactic acid compartment of Figure 24 in the engaged position.

Accordingly, the present invention is directed to an apparatus and methodology for substantially eliminating one or more disadvantages or disadvantages of the related art.

One object of the present invention is to prepare a medical fluid by substantially mixing water and at least one concentrate at the patient's treatment site. This fluid can also be prepared with normal tap water. As a result, the patient ' s treatment requirements can be met through a compact concentrate package, unlike a plurality of fluid bags. This is convenient for both the patient and the doctor. It also reduces weight and volume, thus not only reducing storage costs and shipping costs, but also improving logistics management. Disposable components, including less plastic, may be used less, providing significant environmental benefits.

It is another object of the present invention to provide at least one component of a medical fluid in at least substantially dry form to increase shelf life and / or eliminate problems associated with the precipitation of constituents. At least the glucose may be provided in a substantially dry form.

It is another object of the present invention to provide a universal or nearly universal container (hereinafter referred to as "universal container") container for filling a plurality of patient prescriptions. The dispenser is controlled to mix the appropriate prescription at the treatment site. As a result, a plurality of prescriptions can be obtained using universal containers or cartridges. This reduces the need to list multiple prescriptions.

It is another object of the present invention to provide a container containing at least one concentrate together with a cleaning agent. In this way, the treating agent and the cleaning agent can be conveniently packed together.

It is a further object of the present invention to provide a medical treatment device in which the number of aseptic connections is reduced. There may be no aseptic connections or there may be only one. This reduces the risk of infection, such as peritonitis.

It is a further object of the present invention to provide a system that allows a patient's prescription to be communicated electronically with a catapult through a smart card or the like. According to this method, when the patient's prescription is changed, the dialyzer can be reprogrammed while continuing to use the same universal cartridge.

It is yet another object of the present invention to provide a system that provides more fluid dose during peritoneal dialysis treatment, without significant additional cost, unlike conventional peritoneal dialysis systems where the cost is approximately proportional to the volume of the fluid. The greater volume of fluid indicates that conventional PDs may allow patients to switch to other treatment modalities such as hemodialysis (HD) for longer periods of time in the PD state because conventional peritoneal dialysis provides inadequate treatment Can also mean.

Another object of the present invention is to provide a system that sterilizes peritoneal dialysis fluid immediately prior to administration to a patient to minimize the likelihood of bacteria entering the peritoneum.

It should be understood that the present invention may still be practiced without one or more of the objects and / or the advantages described above, or with an incomplete understanding of such objects and / or advantages. Other objects and advantages of the present invention will become apparent from the following detailed description of the invention and the claims.

To the accomplishment of the foregoing and other objects and advantages, there is provided, in accordance with the purpose of the present invention, many aspects of the invention as embodied and broadly described herein.

According to a first aspect, the present invention provides an apparatus for producing a peritoneal dialysis fluid for introduction into a patient ' s complex membrane at a treatment site,

A plurality of chambers respectively containing concentrates of one component of said peritoneal dialysis fluid,

A fluid mixer configured to mix the concentrates with a liquid to produce a peritoneal dialysis fluid;

A sterilizer configured to sterilize at least one of the liquid and peritoneal dialysis fluid,

And a patient inlet connection configured to fluidically transmit the peritoneal dialysis fluid to a patient ' s membrane cavity,

Wherein at least one of the concentrates is substantially in a dry form and is at least partially dissolved during use of the device to form a portion of the peritoneal dialysis fluid.

The present invention also provides a method of preparing a peritoneal dialysis fluid at a treatment site and introducing the fluid into a patient ' s multiple-cavity steel,

Providing a plurality of concentrates of components of the peritoneal dialysis fluid to each chamber,

Mixing the concentrate with a liquid to obtain a peritoneal dialysis fluid,

Sterilizing at least one of the liquid and peritoneal dialysis fluid,

Introducing the peritoneal dialysis fluid into a patient ' s multiple-skin cavity,

Wherein at least one of the concentrates is substantially in a dry form and is at least partially dissolved to form part of the peritoneal dialysis fluid.

By providing the concentrate in a substantially dry or solid form, such as, for example, a powder, problems associated with liquid concentrates such as precipitation, short shelf life, and the like can be minimized.

At least one of the concentrates is an osmotic agent such as a carbohydrate, a gluconate, a peptide, a ketoacid, a glycerol, a glucose polymer, a disaccharide, and the like. In one illustrative embodiment, the osmotic agent is glucose or glucose. When glucose is provided as a solution, glucose generally has a limited shelf life prior to use. It is also possible to provide a substantially osmotic agent in dry or solid form and dissolve it at the time of use, thereby increasing its shelf life.

At least one of the concentrates is a buffering agent such as bicarbonate, lactate, acetate, pyruvate, hydroxybutyrate, phosphate, and the like. In one embodiment, sodium bicarbonate or sodium lactate, or a combination thereof, is used as the buffer. By providing sodium bicarbonate in a substantially dry or solid form, the problem of solution deterioration due to precipitation of solids can be avoided. Sodium bicarbonate is often preferred as a buffer for physiological reasons, but other buffers are often used during peritoneal dialysis. It is therefore advantageous to use substantially solid sodium bicarbonate which is subsequently dissolved in the solution at the treatment site later in the peritoneal dialysis treatment system.

The concentrate provided in a particular chamber may comprise one or more substances, for example some or all of the electrolyte may be provided in one chamber and the other chamber may be provided with an osmotic agent. In one embodiment, each concentrate includes a separate component material of a peritoneal dialysis fluid. To produce a peritoneal dialysis fluid, each chamber may contain separate component materials of the peritoneal dialysis fluid selected from the group consisting of sodium chloride, sodium bicarbonate, magnesium chloride, calcium chloride, sodium lactate, lactate, and glucose.

One or more of the concentrates may be provided in a liquid form or may be provided in a substantially dry form. In one embodiment, the concentrate comprises a substantially dry form of sodium chloride, a substantially dry form of sodium bicarbonate, a substantially dry form of magnesium chloride, a substantially dry form of calcium chloride, a solution of lactic acid, a substantially dry form of glucose .

According to the first aspect of the present invention, it is possible to manufacture a different preparation peritoneal dialysis fluid by providing, in each chamber, a plurality of concentrates of peritoneal dialysis fluid components. The apparatus includes a controller for controlling the fluid mixer to produce such different peritoneal dialysis fluid preparations. Thus, a selection is made for preparations which can be made using liquids such as purified water (purified water) and multiple concentrates. For example, a single disposable container containing the concentrate can be used to produce different formulations that are required depending on the patient ' s prescription. This is much more convenient than presently available systems that provide peritoneal dialysis fluid to the patient where the manufacturer reserves a range of different dispensing fluid bags and provides the user with a bag of his or her treatment You have to choose and supply. Instead, the user can always be supplied with the same plurality of concentrates, and this concentrate can be used to produce the necessary formulation by the device.

In one embodiment, the concentrate comprises a plurality of electrolytes, and the controller is operable to produce a peritoneal dialysis fluid formulation having electrolytes of different relative concentrations. As such, the device can change the relative concentration of the electrolyte in the peritoneal dialysis fluid according to the patient ' s prescription, instead of simply being able to change the concentration of the osmotic agent (e.g., glucose). This is an improvement over conventional systems that produce peritoneal dialysis fluids at the treatment site using a single combined source of electrolytes. The electrolyte used in the peritoneal dialysis fluid may be one or more of sodium bicarbonate, sodium chloride, sodium lactate, magnesium chloride, and calcium chloride.

In one embodiment, the controller is provided with data input means for receiving prescription information for a patient. Such data input means may include a keyboard, a touch screen, or the like that allows a person to input necessary prescription information. In one embodiment, the data input means includes a memory mechanism, such as a smart card, which may be inserted in a suitable portion of the device. Alternatively or additionally, the data input means may include, for example, a modem for monitoring the device or for sending prescription information to the device, or other means for enabling remote communication.

The concentrate can be dissolved in a chamber in which a substantially dry or solid concentrate is supplied. In the case of some concentrates, a relatively large amount of solution may be required, and without the channel, it is common that the chamber is not large enough to accommodate enough water to dissolve all the concentrate. Examples of such concentrates in peritoneal dialysis solutions are sodium chloride and sodium bicarbonate. In this case, water corresponding to at least one chamber volume is used to dissolve the concentrate. One way of doing this is by using an air vent to fill the chamber with water through the hole and allow the air to enter and fill the chamber (where the walls of the chamber are relatively rigid and the walls of the flexible wall In which case no air vent is required), the chamber is evacuated by reversed flow through the same hole. Next, the charge can be repeated and this process is repeated several times as needed.

In another configuration, the apparatus is arranged to prime a liquid comprising water in at least one concentrate of substantially dry form in each chamber, the amount of concentrate in the chamber and the size of the chamber being such that the chamber is liquid The apparatus comprising a flow line for removing the liquid comprising the dissolved concentrate from the chamber and a liquid supply line for removing substantially the same amount of liquid as the amount removed, And a flow line for adding to the chamber.

This configuration allows for continuous flow to the fluid mixer instead of periodic flow after initial priming to reduce the number of cycles required and the likelihood of occurrence of inaccuracies for a given set of peritoneal dialysis fluid have. As such, two flow lines are provided for simultaneous use. One of these can be conveniently used for priming, and the other can be used to discharge air from the container, which requires an air outlet in the case of a rigid wall chamber. The concentrate removal flow line may be used to introduce liquid containing water into the chamber during priming, and the liquid additional flow line is used to vent air from the chamber during priming. During normal use, no air discharge is required.

This first type of chamber or partial dissolution chamber is suitable for containing sodium chloride or sodium bicarbonate to produce a peritoneal dialysis fluid.

The second type of chamber is contemplated for other components of the peritoneal dialysis fluid, such as calcium chloride and magnesium chloride. In the case of such concentrates, the concentrate is generally only required in relatively small and low concentrations in the peritoneal dialysis fluid, and therefore, even with a relatively small chamber volume, a sufficient amount of concentrate to be dissolved . Thus, the apparatus may be arranged to prime a liquid comprising water in at least one concentrate of substantially dry form in each chamber, the amount of concentrate in the chamber and the size of the chamber being such that when the chamber is filled with liquid It is the amount and size that allows the concentrate to dissolve sufficiently. By using a chamber of this type, the priming influent can conveniently utilize the same flow line as that used to remove the dissolved concentrate from the chamber. In the case of a chamber of a rigid wall, an air outlet may be provided for discharging air during the priming and emptying process.

The third type of chamber may be used for an osmotic agent, usually glucose. The osmotic agent is provided in a substantially dry or solid form, for example in the form of a powder, and the device is suitably mounted so that once the liquid containing water has been added, the glucose is stirred, stirred or recirculated. This is because it is relatively difficult to rapidly dissolve glucose. In one embodiment of the apparatus, each chamber is provided with an osmotic agent, such as glucose, which introduces a liquid containing water into the osmotic chamber and delivers a liquid comprising the dissolved osmotic agent to the chamber And a flow circuit for reintroducing the liquid containing the dissolved osmotic agent into the chamber. For example, the dissolution of glucose is generally promoted by heating the diluting liquid to, for example, 40 占 폚. The heated liquid may be initially fed to the glucose chamber. It is advantageous to keep the glucose in a heated state during dissolution and circulation, and it is therefore advantageous to provide a heater for heating the liquid when liquid containing dissolved glucose circulates around the flow circuit.

Because the glucose powder tends to release air bubbles during dissolution, the device may be provided with an outlet to allow gas to escape when liquid containing dissolved glucose circulates around the flow circuit.

The plurality of chambers containing each concentrate may be provided by one or more vessels. However, it is convenient for the user if all of the ingredients for producing the peritoneal dialysis fluid are provided in a single container. In one embodiment, the plurality of chambers are defined by a disposable container. In another embodiment, each chamber is in the form of a compartment of the container.

It will therefore be appreciated that a plurality of different types of chambers may be provided in order to meet different requirements for different components of the peritoneal dialysis fluid, i.e., considering the amount of each component normally required and the difficulty of dissolving each component There will be. From the user's point of view, however, it is advantageous to provide all of the chambers and components of the peritoneal dialysis fluid these chambers contain in a single container. This can provide all of the ingredients required during the night's peritoneal dialysis session, which allows the user to administer a peritoneal dialysis fluid, for example, 8 to 30 liters or more, without the need to set up the various fluid bags required for conventional peritoneal dialysis procedures And the like.

A chamber communication portion (e.g., a spike) that can support the container at a fixed location on the device and moves to a location that communicates with the interior of the chamber can be provided in the device. In one embodiment, the apparatus includes a container engagement portion that engages the container and forces the container to a position where the chamber is open to communicate with each portion of the device.

Generally, it is desirable to dispose the container at a position where the container can be engaged by the container engaging portion. One way of accomplishing this is to allow the user to slide the container in a first direction, e.g., in the horizontal direction, to the engagement position, and then the container engagement portion forces the container in the second direction, e.g., .

The container engagement may, for example, engage a container area remote from the chamber area where the chamber is open. This may be the base of the container, which may be inverted such that its open area faces downward. In one embodiment, the container engagement portion is arranged to engage with a plurality of flanges provided in the vicinity of each hole of each chamber. By engaging in the vicinity of the hole, the container can be reliably forced into the hole area. The flange is formed, for example, on necks forming the holes of each chamber.

In one embodiment, the flanges associated with each hole engage to ensure that each hole communicates with the chamber communication portion of the apparatus reliably and reliably. It will be appreciated that it is important that all intended communication paths should be formed at the interface between the device and the container. In one exemplary container, there are eight chamber holes through which communication occurs. According to one embodiment of the configuration for achieving a desired reliable interface, at least two container holes are arranged linearly with respect to each other, and each container engagement portion includes a pair of lateral directions As shown in FIG.

In one embodiment of the apparatus, a plurality of spikes are provided to puncture each seal of the chamber to open the chamber. It is advantageous that each spike is provided with two fluid flow channels that allow liquid or gas to flow in and out of the chamber simultaneously or from the chamber. As will be apparent from the following, it is useful to provide three flow channels in the case of a chamber containing glucose, while two channels are provided for other concentrates. Rather than providing three flow channel spikes, a pair of spikes is provided that punctures the chamber containing an osmotic agent, such as glucose. This can provide three flow channels, two by one spike and the third by a different spike. Also, since the osmotic chamber is usually substantially larger than the other chamber, there is sufficient space in the osmotic chamber wall to provide two holes.

One or more peritoneal dialysis patients After using the container to supply the infusion ingredient, the container is removed and a new container is used during the next treatment period. It is advantageous to disinfect the spikes between treatments. The device includes a cover that covers the spike when the container is removed to disinfect the spike. The container engaging portion may be arranged to engage with the lid to force the lid to its covering position. Thus, the container engaging portion can perform both the function of forcing the container to its communicating position and the function of forcing the cover to its covering position in the absence of the container.

It will be appreciated that the container itself, as described herein, implements many advanced aspects. Accordingly, a second aspect of the invention relates to a container as a disposable container.

In one form of the second aspect, the present invention provides a container containing all of said concentrates in concentrated form, said concentrates, when mixed with water, provide a sufficient peritoneal dialysis fluid during the period of peritoneal dialysis treatment .

In another aspect of the second aspect, the present invention provides a container containing a concentrated component of a dialysis fluid, the container comprising a chamber containing powdered glucose and a chamber containing at least one powdered inorganic salt And at least one other distinct chamber.

In another aspect of the second aspect, the present invention provides a container containing a concentrated component of a dialysis fluid, said container comprising at least one chamber containing a detergent and at least one powdered inorganic salt And at least one other distinct chamber. It is advantageous to provide the same container with a detergent as at least one concentrate for making a peritoneal dialysis fluid, which, in order to provide a concentrated PD fluid and provide a detergent, This facilitates the operation of the device because only one container has to be inserted into the device.

In another aspect of the second aspect, the present invention provides a container containing a concentrated component of a dialysis fluid, wherein the container forms at least two distinct chambers therein, each chamber containing a different inorganic salt , The volume of each chamber and the amount of salt contained in each chamber is a volume and an amount such that the conductivity of such a solution is characteristically different when each salt solution is prepared by filling each chamber with a liquid such as water. As will be described in greater detail below, this configuration allows the use of the apparatus to inspect each container to ensure that it contains the correct concentrate or inorganic salt from each chamber.

In another aspect of the second aspect, the present invention provides a container containing a concentrated component of a dialysis fluid, wherein the container forms a plurality of distinct chambers therein, the container comprising at least Wherein each connector includes at least two separate fluid channels to enable simultaneous inflow and outflow into and out of each chamber. This arrangement allows the gas to escape through the fluid channel as the liquid enters the fluid channel, and / or as the liquid escapes through the fluid channel, the gas enters the chamber through another fluid channel And / or allows a replacement liquid to enter the chamber as the liquid exits the chamber. This configuration is particularly useful when the chamber has a relatively rigid (i. E., Collapsible) wall instead of a flexible wall, the volume of which is substantially constant whether the chamber is empty or filled. By providing at least two fluid channels as part of the connector, as opposed to providing an outlet at any location on the chamber, the two fluid channels can be moved simultaneously by destroying the seal, which may be, for example, in the form of a membrane or diaphragm It can only be opened and determined when it is used.

In one configuration, the at least two fluid channels are concentrically disposed in each connector. This type of connector can be conveniently combined, for example, with spikes, which are themselves provided with two fluid channels as described above.

In the case of a chamber containing an osmotic agent, such as glucose, it is useful to provide two or more, in particular three, fluid channels. In one embodiment, at least one of the chambers includes two connectors, one of which includes the at least two separate flow channels, and the other includes an additional fluid channel.

And, in the case of an osmotic agent, such as glucose, its dissolution can advantageously be facilitated by providing a diffuser that diffuses the liquid influx into the chamber into one of the fluid channels.

In one embodiment, the connector is provided in the lower region of the chamber during operation, and one of the fluid channels of the at least one connector has a portion extending into the upper region of the chamber. Portions of this upper region can be used, for example, as air outlets, as alternate fluids or as recirculation inlets.

As described above, at least some of the holes in the chamber are aligned with each other. The holes are aligned with one another along a straight axis. Thus, both of the connectors can engage the container engagement portion of the device. The connectors may include a neck portion formed with an outer flange for engaging the container engagement portion. A pair of flanges may be provided on both sides of the neck portion, or one flange may extend circumferentially around the neck portion. Next, the container engaging portion may be in the form of a pair of laterally spaced members (forks) engaging with the flange.

The container should be mounted on the dialyzer in a unique manner or insertable into the dialyzer to ensure that the correct connector is aligned with the necessary communication of the device. In one embodiment, the linear axis of the mutually aligned connector is biased from the central axis of the vessel. The container can then interface with the device only in the correct manner.

In another aspect of the second aspect of the present invention there is provided a container for use in priming powdered glucose at a patient ' s treatment site, wherein the lower region of the container is formed by dissolving the powdered glucose in the container And an inlet for receiving the feed water, wherein the inlet is provided with a diffuser configured to diffuse the water stream into the powdered glucose.

In another aspect of the second aspect of the present invention, there is provided a container for a concentrated component of a dialysis fluid, wherein a plurality of discrete chambers are formed, the container having at least one connector associated with each chamber Wherein at least two of the connectors are aligned with one another along a linear axis.

In another aspect of the second aspect of the present invention, there is provided a container for a concentrated component of a dialysis fluid, wherein a plurality of distinct chambers are formed, the container comprising a container body and at least There is at least one axis including one connector, the container body being generally rotationally symmetric, and the connector is arranged with respect to the container body so as to be rotationally asymmetric about the axis.

In the manufacture of the vessel, each chamber can be loaded with an appropriate concentrate. Continuous charging of each chamber of a single vessel may be problematic. Thus, the container may be made of a plurality of sub-containers which are later joined together.

In another aspect of the second aspect of the present invention, the present invention provides a method of preparing a container for a concentrated component of a dialysis fluid,

Manufacturing a plurality of individual sub-vessels,

And connecting the sub-containers to form the container.

The invention also extends to a container made by the method.

The device may be connected to a purified water source, such as a reverse osmosis unit. In one embodiment, the apparatus comprises a water purifier. The water purifier includes, for example, one or more reverse osmosis membrane units. In one embodiment, the water purifier includes a first reverse osmosis membrane unit and a second reverse osmosis membrane unit. Each osmosis unit has an inlet, a purified water outlet, and a wastewater outlet. In one embodiment, the purified water outlet of the first osmosis unit is in fluid communication with the inlet of the second osmosis unit. Moreover, the wastewater outlet of the second osmosis unit may be in fluid communication with the inlet of the first osmosis unit.

According to the above configuration, the water, which has already been properly pure and has passed through the first osmosis unit, is regenerated and passes through the first osmosis unit again so that the total water consumption . In this way, two osmosis units can be used to provide high purity water without increasing the total water consumption of the device.

The water purifier may comprise, for example, a rough filter (e.g., a 30 micron filter), a fine filter (e.g., a 5 micron filter), a charcoal filter and / or a water softener upstream of the inlet of the osmosis membrane unit It is possible. Each of these components prevents the reverse osmosis membrane from being closed.

The water purifier may further include a degassing device on an upstream side of the first (or second) reverse osmosis membrane unit. The water is degassed before passing through the reverse osmosis membrane unit, and the amount of carbon dioxide and other gases dissolved in the water is reduced, so that the performance of the reverse osmosis membrane can be improved. In addition, the bubbles in the water may interfere with the correct operation of the pump and the like. Generally, it is desirable to degass the water at an early stage of the production of the peritoneal dialysis fluid, since this simplifies the further processing steps since the dissolved gas content of the water is fixed.

In one embodiment, the sterilizer is a heat sterilizer.

From a third aspect, the invention provides an apparatus for generating a peritoneal dialysis fluid at a treatment site,

A water inlet for receiving the water supplied from the main water supply part,

A water purifier for purifying the water supplied from the water inlet,

A fluid mixer for mixing the purified feed water with a peritoneal fluid concentrate to supply a peritoneal dialysis fluid,

A sterilizer for sterilizing the supplied peritoneal dialysis fluid; and

And a fluid outlet configured to deliver the sterilized peritoneal dialysis supply fluid to a patient ' s multiple membrane steel,

The sterilizer is a heat sterilizer configured to thermally sterilize the peritoneal dialysis fluid at a sterilization temperature and a pressure increase state.

Heat sterilization is generally considered to be more effective and safe than, for example, bacterial filtration.

In one embodiment, the sterilizer is provided on the downstream side of the fluid mixer to neutralize any bacteria introduced into the peritoneal dialysis fluid during mixing. In this way, since the concentrated component does not need to be pre-sterilized, the manufacturing cost of the concentrated component container can be reduced.

Although the sterilizer may be configured to sterilize the peritoneal dialysis fluid itself, alternatively, to sterilize one or more peritoneal dialysis fluid components such as a peritoneal dialysis fluid and / or a liquid (e.g., water) used to form a concentrated solution One or more sterilizers may be provided. If the concentrate is provided as a sterile concentrate, only the water used to form the peritoneal dialysis fluid is sterilized.

The sterilizer may comprise a sterilizing flow passage and is configured to thermally sterilize the fluid as the peritoneal dialysis fluid flows along the sterilizing flow passage so that the peritoneal dialysis fluid flow does not need to be stopped for heat sterilization do. In one embodiment, the device comprises, on the downstream side of the thermal sterilizer, a flow path for allowing the sterilized peritoneal dialysis fluid to flow into the patient infusion connection, and a flow path for the sterilized peritoneal dialysis fluid as the sterile peritoneal dialysis fluid flows along the flow path To cool the peritoneal dialysis fluid so that when the peritoneal dialysis fluid reaches the patient inlet connection, the temperature of the fluid becomes the body temperature. The device may be configured to thermally sterilize the flow path through which the sterilized peritoneal dialysis fluid flows into the patient infusion connection, prior to use of the device, to ensure that the sterilized fluid migrates along the sterilized path.

A fourth aspect of the invention relates to a system for dissolving a substantially dry concentrate and delivering the dissolved concentrate to a mixing vessel.

Thus, from a viewpoint of the fourth aspect, the present invention provides an apparatus for producing a medical aqueous solution from a plurality of concentrates, the apparatus being configured to communicate with a plurality of chambers containing respective concentrates, At least one of which is substantially in a dry form,

At least one flow line configured to prime the at least one concentrate in the substantially dry form with a liquid comprising water to form at least one dissolved concentrate,

A mixed vessel configured to receive the at least one dissolved concentrate,

And a flow regulator associated with at least one dissolved concentrate of the upper extremity to deliver the concentrate to the mixed vessel,

Measuring means configured to measure a concentration of the at least one dissolved concentrate;

Pumping the at least one dissolved condensate of the metered volume through the associated flow regulator to the mixed vessel while measuring the concentration of the dissolved concentrate by the measurement means to produce a predetermined amount of the dissolved concentrate And a pump for feeding the mixed gas to the mixing vessel.

The present invention also provides a method of providing a medical aqueous solution from a plurality of concentrates,

Providing a plurality of concentrates in at least one substantially dry form in separate chambers,

At least one concentrate of said substantially dry form is primed with a liquid comprising water to form at least one dissolved concentrate,

Sending the at least one dissolved condensate to a mixing vessel via a flow regulator associated with the concentrate,

Adjusting the flow regulator associated with the at least one dissolved concentrate to pass the concentrate of the metered volume through the flow regulator,

Measuring the concentration of the concentrate to determine the amount of the concentrate to be fed to the mixed vessel,

And terminating the feeding of the concentrate if a predetermined amount of the concentrate is fed.

Thus, an aqueous solution can be obtained from a mixed vessel containing at least a predetermined amount of each concentrate from the starting point of the concentrate, at least one of which is substantially dry, for example in the form of a powder, so that each concentrate is present at a predetermined concentration ratio. Such solutions may be prepared with the desired precise preparation or may be used for medical purposes, such as peritoneal dialysis, hemodialysis, hemofiltration or hemodialysis filtration purposes.

In general, it is intended to obtain a predetermined concentration of concentrate stream, since this requires time, e.g., to achieve dissolution, or because adjustment, such as dilution, is made to achieve a predetermined concentration of stream, It may take time to It is advantageous to use the flow as soon as it is set to the desired concentration, rather than to discharge the desired flow while waiting for a similar setting to be made for the other concentrate. By providing a mixed vessel in which a known amount of concentrate is stored, the concentrate can be directed to the mixing vessel without delay and thus without a significant loss in the effluent.

When a plurality of concentrates are provided in a substantially dry form, each of these concentrates is primed to form a dissolved concentrate, and a solution of the dissolved concentrate As the concentration is being measured, the molten concentrate of the metered volume is pumped through the associated valve to the mixing vessel. Thus, an aqueous solution containing a predetermined amount of each concentrate is obtained.

If one or more of the concentrates are initially provided in liquid form, the concentrates may be provided at known concentrations, in which case the concentration measurement step may not be necessary and pumping the metered volume into the mixed vessel Suffice. However, the concentration of the concentrate in the initial liquid form can be measured when the concentrate is sent to the mixed vessel in order to ensure that all of the concentrate is obtained in the mixed vessel. This is also useful when the concentrate is initially provided in approximate concentrations in liquid form. One example of a concentrate that may be provided in liquid form to make a peritoneal dialysis fluid, for example, is lactic acid.

Thus, another method comprises adjusting a first flow regulator associated with the first concentrate to allow the first concentrate to pass through the first flow regulator at a metered rate, measuring the concentration of the first concentrate, To deliver the first concentrate when a predetermined amount has been delivered and to allow the second concentrate to pass through the second flow regulator at a metered rate, Adjusting the associated second flow regulator, measuring the concentration of the second concentrate to determine the amount of the second concentrate fed to the mixed vessel, and, if a predetermined amount has been fed, feeding the concentrate fed to the mixed vessel And repeating said adjustment, passing, measurement and termination for each additional concentrate to provide an aqueous solution comprising a predetermined amount of each concentrate The. This method can be applied to a plurality of concentrates in which at least one concentrate is provided in a substantially dry form, i.e., a plurality or one is initially provided in liquid form, or none of which may be provided in liquid form. To prepare a dialysis fluid, for example, the electrolyte and the osmotic agent may be provided as a solid concentrate, for example as a powder, or as an acid concentrate.

In one embodiment, the apparatus comprises a flow regulator associated with each concentrate, wherein, in use of the apparatus, in order to deliver a predetermined amount of concentrate to the mixing vessel, while measuring the concentration of the concentrate, Each concentrate of the volume is pumped through the associated valve to the mixing vessel. For example, there may be a first flow regulator associated with the first concentrate, a second flow regulator associated with the second concentrate, and an additional flow regulator associated with each additional concentrate.

The pumping operation of the concentrate flow may be accomplished by a plurality of mechanisms, such as, for example, a metering pump associated with each concentrate. In one embodiment, the pump is again configured to pump each concentrate into a mixed vessel. Thus, the use of pumps associated with each concentrate can be avoided, which can reduce the cost, size and weight of a system, particularly where various concentrates are included, as in the case of dialysis liquids for example.

Similarly, a plurality of concentration measuring means associated with each concentrate again may be provided, but each concentrate may alternatively be passed through the same measuring means. This may reduce the cost, size and weight of the system. In addition, since the measuring means individually measures the concentration of each concentrate, it can be selected or set up to provide accurate measurements over a sufficiently wide range to encompass each expected concentration. This is because the conductivity is increased as additional concentrate is added and the measuring means is required to be accurate over a wide range, for example, to a sufficient extent to cover the conductivity of the first concentrate, so that the conductivity of the solution, The greater the conductivity of the combined first concentrate and the second concentrate, and the like. Also, in such an accumulation system, the measurement error resulting from the measurement of the first concentrate is added to the measurement error of the second concentrate or the like, and later concentrates are measured with lower accuracy than the initial one. This does not occur if the concentration of each concentrate is measured separately, since the errors are due only to the measurements made.

The measuring means may comprise one or more measuring instruments, such as two measuring instruments, to provide extra to the system and thus provide additional stability. The measuring means may include a pH meter, or other type of meter such as an ion selectivity meter, but preferably includes a conductivity meter.

The device may be configured to dilute the concentrate after the concentrate leaves each chamber and before the concentrate is sent to the mixing vessel. By controlling the amount of dilution, the concentration of the constituent material fed to the mixed vessel is maintained at a predetermined concentration, even when starting from different preliminary dilute concentrates, which may be a state corresponding to a concentrate initially provided in a substantially dry form Lt; / RTI > The dilution may be done, for example, by a proportional pump. In one dilution device, the apparatus includes a concentrate flow line and a water flow line, wherein the concentrate is pumped along the concentrate flow line at a metered rate by the pump, Is pumped at a rate metered by the second pump and the concentrate flow line is combined with the water flow line such that the concentrate and water are mixed before the concentrate is sent to the mixing vessel to dilute the concentrate . The concentration of the concentrate or diluted concentrate is measured and the pump is controlled to provide the dilution ratio required to obtain the desired concentration of diluted concentrate.

A convenient method of delivering a predetermined amount of concentrate to a mixed vessel is by sending the diluted concentrate to a mixed vessel at a predetermined flow rate, measuring the concentration of the diluted concentrate, multiplying the measured concentration by the flow rate, Integrating the value of the product over time to obtain the total amount of concentrate fed to the mixed vessel and terminating the delivery of the diluted concentrate to the mixed vessel if a predetermined amount of concentrate has been delivered to the mixed vessel do. Thus, the apparatus may comprise a suitable processor for performing the multiply, integrate and terminate functions.

The plurality of chambers containing the concentrate are usually provided at a predetermined position with respect to each other and with respect to the apparatus, in order to ensure that each concentrate is fed to the appropriate site of the apparatus. In one embodiment, the device can check whether it has received the correct concentrate at each suitable site. Thus, the method includes determining the nature of the concentrate, or the nature of the concentrate after dilution on its downstream side of each chamber, and determining from the measurement whether the concentrate is a predicted concentrate from the chamber.

For example, when the measured properties are pH, it may be difficult to distinguish concentrates having a neutral pH at any concentration. In one embodiment, the measured property is a conductivity. The concentrate may be provided in each chamber in an amount such that the properties, e.g. conductivity, can be distinguished from each other if measured later. The properties may be measured as supplied from the chamber, i. E. Without further dilution. When measuring after dilution, the dilution is made by adding a liquid containing a known amount of water, and measurements on the expected concentrate are still visible.

The concentration of the concentrate in the mixed vessel may provide a final formulation suitable for the desired medicinal use. However, in order to keep the mixed vessel at a reasonable size, in one embodiment, the liquid in the mixed vessel is passed toward the point of use to dilute the liquid downstream of the mixed vessel.

Dilution can be achieved by feeding water from the mixed vessel into the water guide line, wherein the liquid in the mixed vessel is pumped at a known rate and the diluted liquid is pumped at a higher known rate, And a known flow rate of the diluted liquid. Therefore, the degree of dilution is known. In order to ensure that the correct formulation is obtained for the diluted liquid, it is also checked, for example in connection with its medical use as a peritoneal dialysis fluid, that the degree of dilution is correct. This may be achieved by providing suitable measuring means such as conductivity measuring means. The cost, size and weight of the device can be minimized by measuring the concentrate concentration of the diluted liquid downstream of the mixing vessel, using the same measuring means used to measure the concentration of the concentrate during feeding to the mixing vessel have.

When using a common flow path at several points downstream of the valve associated with each concentrate, it is desirable to flush such flow path (or a portion of the flow path) after feeding one concentrate and before feeding the next concentrate You may. In one arrangement, the pump is reversible and connectable to a liquid source, so that, in use of the apparatus, after termination of the feeding of the concentrate, the pump is inverted to pump the liquid from the liquid source through the associated flow regulator, Flushes the flow path between the liquid source and the flow regulator, such as a valve. The liquid used for the flush treatment is preferably water.

From the foregoing it will be appreciated that the system for producing different medical formulations at the treatment site includes additional progressive aspects. Thus, a fifth aspect of the invention relates to such a system.

In one form of the fifth aspect, the present invention provides an apparatus for use in a treatment site, wherein a plurality of concentrates are used and from which a different range of peritoneal dialysis fluid preparations can be made Each of these preparations being based on predetermined prescription information and comprising at least one diluted form of the concentrate.

Such a device is advanced compared to known peritoneal dialysis systems, including using a range of ready-to-use formulations, the known system being made far from the treatment site, selected according to the required formulation, Must be transported. Instead, a plurality of concentrates are used by the device, which constitutes the necessary preparations in situ, in accordance with prescription information set by a physician or other qualified medical professional. This simplifies the manufacturer's storage inventory control, which the manufacturer no longer needs to produce a range of different ready-made combinations, but instead can supply a plurality of concentrates. This is also more convenient for doctors and patients, and they do not have to worry about confirming that they are being supplied with precisely prepared fluid bags.

In another aspect of the fifth aspect, the present invention provides an apparatus for generating a peritoneal dialysis fluid for introduction into a patient ' s complex membrane at a treatment site,

A plurality of chambers containing concentrates each composed of components of a peritoneal dialysis fluid,

A fluid mixer configured to mix the concentrate with a liquid to produce a peritoneal dialysis fluid,

A controller configured to control the fluid mixer to selectively produce a peritoneal dialysis fluid selected from a group of dispensing agents that are different from each other;

A sterilizer configured to sterilize at least one of the liquid and the peritoneal dialysis fluid;

And a patient inlet connection configured to fluidically transmit the peritoneal dialysis fluid to a patient ' s membrane cavity,

Wherein the controller is provided with data input means for receiving predetermined prescription information for a patient and the controller is operable to control the fluid mixer to produce a peritoneal dialysis fluid preparation based on the received predetermined prescription information .

Thus, a plurality of concentrates may be used to produce a preparation based on the prescription prescribed by the patient and prior to treatment. There is no need to use a different set of concentrates for each preparation and thus no set of concentrates fed to the treatment site is required. Since the prescription process is separate from the dispensing process, the clinician can freely change the prescription from one treatment to the next treatment, for example. Because of the greater flexibility in the prescription provided, the patient may be kept in a peritoneal dialysis treatment for a longer period of time prior to conversion to hemodialysis treatment.

In one embodiment, the chamber is in the form of a compartment of the vessel, and all the concentrate necessary to produce the peritoneal dialysis preparation is provided in the compartment. Thus, only one concentrate container can be used to make a range of different formulations, again simplifying the use of the patient and the patient's system.

The concentrate may comprise a plurality of electrolytes and the controller is selectively operable to produce a peritoneal dialysis fluid preparation having a different relative electrolyte concentration. Therefore, the level of the relative electrolyte can be changed in consideration of the excess or deficiency of a certain salt or ion of the patient. Again, this can be done without having to worry about which preparation bags are ready for use at the treatment site.

In another aspect of the fifth aspect, the present invention provides an apparatus for producing a peritoneal dialysis fluid for introduction into a patient ' s complex membrane at a treatment site,

A plurality of chambers containing respective concentrations of the components of the peritoneal dialysis fluid,

A fluid mixer configured to mix the concentrate with a liquid to produce a peritoneal dialysis fluid,

A controller configured to control the fluid mixer to selectively produce a peritoneal dialysis fluid selected from a group of different combinations,

A sterilizer configured to sterilize at least one of the liquid and peritoneal dialysis fluid,

And a patient inlet connection configured to fluidically transmit the peritoneal dialysis fluid to a patient ' s membrane cavity,

Wherein the concentrate comprises a plurality of electrolytes and the controller is operable to selectively produce a peritoneal dialysis fluid preparation having different relative concentrations of electrolyte.

The advantages of such a device will become clear from the following description.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the invention, without limiting the scope of the invention as claimed.

In the following, embodiments of the invention will be described by way of example only with reference to the accompanying drawings, which form a part hereof and are incorporated in and constitute a part of this specification.

1 is a schematic partial perspective view of an apparatus 100 for preparing a patient peritoneal dialysis fluid according to a first embodiment of the present invention. The apparatus 100 is connected to the domestic tap water supply unit by the tap water connection unit 1 and is connected to the domestic waste water system by the external drain connection unit 16. The outer wastewater connection 16 may be in the form of a replaceable wastewater line. The device 100 is turned on by the home power supply through the main electrical connection 20. [ The concentrated component of the peritoneal dialysis fluid is supplied to the device 100 in a disposable concentrate container 402. The PD fluid is supplied to and discharged from the patient's peritoneal cavity by a disposable fluid line (10) that forms a fluid connection between the patient and the device (100).

The device 100 receives the detailed prescription content of the PD fluid for the patient on the smart card 102 read by the device. The device 100 also includes a control panel 104 that displays information to the patient and allows the patient to control the operation of the device at some point.

The device 100 according to the present embodiment of the present invention is installed in the patient's home and is used to purify the tap water coming out from the tap connection 1 and to purify the purified tap water from the disposable concentrate container 402 PD fluid component to produce a PD fluid. Next, the device 100 sterilizes the PD fluid and directs the PD fluid through the disposable fluid line 10 directly into the patient's multiple-membrane cavity. During the treatment period, which includes a series of infusion and drainage cycles, during the night when the patient is usually sleeping, the dialysate, the old PD fluid, is removed and a new PD fluid is added to the patient's multiple skin.

The disposable container 402 may include a bar code 18 at a convenient location on the container. The bar code reader 19 (indicated by the dashed line) inside the apparatus 100 reads the bar code when the container is inserted into the apparatus.

Although the device 100 is intended primarily for use in a patient's home, the device 100 may be used in centers such as dialysis clinics and hospitals. The apparatus includes a control system (not shown) that monitors and controls the operation of the apparatus 100 during normal use. Apparatus 100 may include, in addition to the control system, a protection system (not shown) that monitors the correct operation of the device 100 to ensure that the safety of the patient is not impaired, independent of the control system, . The control system and the protection system can perform functional tests to ensure that they are operating correctly.

At the beginning of the treatment period, the user, e.g., the patient, is required to check some intended treatment parameters displayed on the control panel 104. [ Such variables include, for example, the name of the patient, the volume of the PD fluid that should enter the patient ' s abdominal cavity, the glucose concentration of the PD fluid, or the expiration date of the disposable concentrate container 402. Some of these variables are stored in the smart card 102. This corresponds to a conventional PD treatment step in which the patient compares the label of the plastic PD fluid bag to the physician's instructions. Further, at the beginning of the PD treatment, the patient is required to distinguish himself from the patient in order to prevent the device from being operated by unauthorized persons.

At the end of the treatment period, the disposable concentrate container 402 is replaced and the old container is discarded. Similarly, the disposable fluid line 10 is also replaced with a new line at the end of the treatment period.

At the beginning of the treatment period, the patient can set the concentration of glucose needed for the PD fluid required for that treatment period within a predetermined limit, depending on the patient ' s requirements. The glucose concentration is determined using the control panel 104 by the patient. Since glucose in the PD fluid acts as an osmotic agent, an increase in glucose concentration results in an increase in the volume of fluid drained across the patient ' s peritoneum during PD treatment.

The device 100 is suitable for continuous cycle peritoneal dialysis (CCPD) in which the bifacial cavity is filled with PD fluid with a periodic process, usually overnight, and the fluid is emptied. The apparatus 100 may also perform tidal peritoneal dialysis, wherein the peritoneal membrane is initially filled with PD fluid, and in a subsequent cycle a volume smaller than the initial total filling volume is withdrawn from the peritoneal cavity Drained and replaced with the same volume of approximately new fluid. This peritoneal dialysis procedure may occur while the patient is sleeping, and thus the device 100 is usually placed near the bed of the patient. Other treatment modes are also possible.

At the end of the treatment period, the patient's peritoneal cavity may be left with the PD fluid filled or the PD fluid drained from the submerged membrane, depending on the conditions of the patient. Generally, the device 100 is expected to be the sole source of supply for a patient's PD treatment. Thus, if the patient's multiple skin cavity is filled with PD fluid at the end of the treatment period, it is expected that the multiple skin fluid will be filled with PD fluid at the beginning of the next treatment period. However, the patient ' s multiple membrane steels may be drained or filled using additional PD treatment devices during normal treatment periods. The device 100 can cope with this situation by providing input means for allowing the patient to enter relevant data into the device.

In the normal treatment period, a total of about 8-25 liters of the PD fluid is injected into the patient's peritoneal cavity and removed from the peritoneal cavity, with each infusion volume ranging from 250 ml to 3 liters (e.g., in the case of periodic peritoneal dialysis The volume may be smaller). Up to 20 dosing and dispensing cycles may be included in one treatment period, up to 25 liters of PD fluid (50 liters if the disposable concentrate container 402 is changed) is delivered to the patient and the maximum 35 liters of fluid is expelled from the patient and the discharge volume is 4 liters per cycle at most.

The patient instructs the device 100 via the control panel 104 to end the treatment period and allow the patient to disconnect from the device 100 or to remove the portion of the cycle early in the treatment period The treatment period can be terminated.

The device 100 includes a timer (not shown), which allows the patient to set an approximate time at which the treatment period should start so that the device 100 may be ready for the treatment period before the patient arrives It will help. Thus, once this time has been set, the treatment can be initiated within 20 minutes, preferably within 10 minutes after confirming that the treatment period is substantially needed as the patient arrives. If the timer is not set in advance, the device 100 may require up to one hour to prepare for the delivery of the dialysis fluid.

The control panel 104 includes a 256 color video touch screen with a screen saver. The control panel allows the user to set the concentration of the glucose level of the PD fluid within a predetermined limit, or to initiate, block, resume, or terminate the treatment period, or to adjust the temperature of the dialysis fluid to 35 [ Or to set a scheduled start time for the next, or subsequent, treatment period. The control panel displays the treatment state, the time to the end of the treatment period during treatment, or the time to the start of the treatment period during the treatment period preparation. The control panel 104 may be configured to determine the duration of the treatment, such as treatment mode (e.g., periodic peritoneal dialysis or continuous peritoneal dialysis), number of cycles in the treatment period, glucose concentration, accumulated fill volume for the treatment period, Accumulated ultrafiltration volume for the treatment period, fluid delivery temperature set point, patient identification information from the smart card 102 or information entered by the patient, the state of the treatment period, and a technical error code . The ultrafiltration volume is the difference between the volume of the PD fluid delivered to the patient and the volume of the PD fluid drained from the patient. The control panel can also display a visual alarm and an audible alarm is provided to allow the device 100 to alert the patient of an operational problem. The control panel 104 may also be arranged to display additional information for use by the nurse, such as service information and charge rate and volume, if the nurse is able to provide an appropriate identification code.

The device 100 can be signaled by a service engineer via a remote connection, such as a modem (not shown) or directly, using a laptop computer (not shown).

The smart card 102 stores the prescription of the patient, and for each last 20 treatment periods, the prescription, hyperfiltration volume, monitor distinction, date and time, and any variations between the prescribed treatment and the sent prescription were reported to the monitor If such a reason is stored. The smart card 102 also stores a selected level of acceptable limits for the patient, such as patient's identifying information, number of cycles, and glucose concentration. The device 100 can be used to distinguish between a PD 200 card used in a PD 200 ' s peritoneal dialysis system manufactured by Gambro AB in Lund, Sweden, and a card suitable for use with the device 100 Though possible, the physical properties of the smart card are similar to those used in the PD 200 ™ peritoneal dialysis system.

The information on the smart card 102 may be changed by a physician connecting the computer 100 with a suitable interface (not shown) to the device 100 or by inserting the smart card 102 into a suitable card reader attached to a computer (not shown) . A service representative may also input a signal to the device 100 using a computer (not shown) and a data link directly connected to the device.

Figure 1A shows a block diagram of a smart card reader 103 connected to an operating system processor 108 and a protection system processor 106. [ The processors operate and monitor the system in a manner already known in the art of dialysis. The processors are also connected to the control panel 10. The processors 106 and 108 are associated with memory devices 110 and 112, such as volatile memory, static memory, hard disks, solid state memory mechanisms, and the like.

The operating system processor receives an output control signal that controls the process of the device, such as data, valves and pumps, input from sensors and other means of the device.

The protection system processor receives output control signals intended to monitor input data from the sensor and other means of the device, the operating system processor and other processes of the device. The protection system sensor is separate from the operating system processor sensor.

Fig. 2 schematically shows the fluid path of the device 100 shown in Fig. For ease of understanding, the device is shown as six interconnected functional modules, each of which performs a specific role in preparing the peritoneal dialysis fluid and peritoneal dialysis procedure. These modules include a water preparation module 200, a thermal control and sterilization module 300, a concentrate mixing module 400, a drain module 500, a cycler and a sterilizable connector module 600, and a sampling module 700 .

In the following, the overall structure of the fluid path of the device 100 will be described, and further detailed description of each module will be given.

As used herein, the terms " cleaning "," disinfecting ", and " sterilization " That is, " rinsing " simply means removal of the laminate in the system, " disinfection " means neutralization of most bacteria, and " sterilization " is to inactivate all bacteria with a confidence level of 10 ⁶ , Is that the theoretical probability that a possible microorganism will be present is 10 ^-6 or less [see Unites States Pharmacopoeia, 23th Edition and European Pharmacopoeia 1997].

As shown in FIG. 2, the tap water coming from the supply part of the home is supplied to the water preparation module 200 through the tap water connection part 1. The water preparation module 200 controls water supply to other modules in the apparatus by switching the tap water supply unit on and off, limiting the pressure of the tap water supply unit, and monitoring the availability of the tap water supply unit. The water preparation module 200 also reduces and controls the level of dissolved gas in the water supplied to the concentrate mixing module 400, the level of chemical and microbiological contamination. The water preparation module 200 is operable in drinking water standards such as those generally defined by the US Environmental Protection Agency in the November 1996 drinking water standard and has a pressure of 1 to 6 bar gauge (100 to 600 kPa more than atmospheric pressure) Lt; RTI ID = 0.0 > 30 C. < / RTI >

The water preparation module 200 is connected to the thermal control and sterilization module 300 through five fluid connections 2a to 2e. The cooling water output connection (2a) supplies water softened and pressure controlled for use in the cooling function of the thermal control and sterilization module (300). The temperature of the cooling water is elevated in the thermal control and sterilization module 300 due to the water used, at least in part, for cooling purposes. In this manner, the water returned to the water preparation module 200 is preheated using waste heat from other portions of the device 100 to improve the efficiency of the water preparation module. The cooling water is returned from the thermal control and sterilization module 300 to the water preparation module 200 through the cooling water return connection 2b at a controlled temperature of about 30 占 폚.

The purified water prepared by the water preparation module 200 is sent to the thermal control and sterilization module 300 through the purified water connection 2c. The wastewater from the water treatment process is sent to the thermal control and sterilization module 300 from the water preparation module 200 through the purification waste connection 2d and cooled.

The water preparation module 200 exhausts excess gas to the atmosphere through the isolator air outlet 17. [ The water preparation module 200 may vent air to the thermal control and sterilization module 300 through the patient heat exchanger exhaust connection 2e and vent air from the module.

For the purpose of disinfection, the water preparation module 200 receives water at the disinfection temperature from the concentrate mixing module 400 via the reverse osmosis membrane disinfection connection 3.

The water preparation module 200 has a connection for the disinfection cartridge 210 which supplies chemical disinfectant for disinfection of the water preparation module 200 if necessary.

The thermal control and sterilization module 300 sterilizes the PD fluid supplied to the patient and supplies hot enough water (hot water) for disinfection of the concentrate mixing module 400 and the drain module 500.

The thermal control and sterilization module 300 is also supplied to the water preparation module 200 through the cooling water return connection portion 2b and the temperature of the water supplied to the concentrate mixing module 400 through the mixed water supply connection portion 4a . One important role of the thermal control and sterilization module 300 is to prevent heat from being discarded and to advance the heating operation so that the device does not need more power than can be supplied by a household power socket . The device 100 is designed to operate from a mains power of 90-140 V, 10 A, 50/60 Hz (e.g., North America and Japan) or 198-253 V, 10 A, 50/60 Hz (e.g., Europe). Thus, the maximum power consumption of the device 100 is 0.9 kW to 2.5 kW. During injection of the PD fluid into the patient, the power consumption is about 1.2 kW. Power is 300 ml / min. If it does not provide enough power to sterilize the PD fluid at the flow rate, the flow rate is reduced to, for example, 150 ml / min, thereby reducing the power required to sterilize the PD fluid. Most of the energy consumption of the device 100 is required to heat the water and the PD fluid for disinfection and sterilization during injection into the patient.

The connection between the water preparation module 200 and the thermal control and sterilization module 300 has been described above. The thermal control and sterilization module 300 also supplies the temperature-controlled purified water to the concentrate mixing module 400 through the mixed water supply connection 4a. The output of the concentrate mixing module 400, such as the PD fluid, is returned to the thermal control and sterilization module 300 through the mixing module output connection 4b.

Fluid entering the thermal control and sterilization module 300 at the mixing module output connection 4b passes through the input side volumetric flow meter 350 which is connected to the volume of the fluid supplied to the patient when the device supplies the PD fluid to the patient . An output side volumetric flow meter 650 is provided in the cycler and sterilizable connector module 600 to measure the volume of fluid removed from the patient. The change in fluid level of the patient's body due to PD treatment is calculated by subtracting the volume of fluid drained from the patient from the volume of fluid supplied to the patient. This change is referred to as the ultrafiltration volume (UF), and is accurate to ± 66 ml (or greater, 0.66% of the total fill volume) over the treatment period, preferably ± 33 ml (or, if greater, Of 0.33%), which is measured in the range of -4 liters to +10 liters.

When treating the patient, aseptic PD fluid is sent from the thermal control and sterilization module 300 to the cycler and sterilizable connector module 600 via the sterile fluid connection 8a. During the sterilization process of the cycler and sterilizable connector module 600, water at sterilization temperature is sent from the thermal control and sterilization module 300 through the sterile fluid connection 8a to the cycler and sterilizable connector module 600 , And returns to the thermal control and sterilization module (300) via the sterile output connection (8b). The sterilized water returns to the cyclic and sterilizable connector module 600 via the sterile fluid return connection 8c after heat recovery by the thermal control and sterilization module 300.

The thermal control and sterilization module 300 is connected to the drain module 500 through the heat exhaust connection 13a used to send the wastewater from the clean water connection 2d to the drain module 500 after heat recovery. During disinfection, the fluid is sent from the drain module 500 to the thermal control and sterilization module 300 through the heat recovery drain connection 13b to the low pressure for heat recovery. The fluid returns to the drainage module 500 through the heat recovery drainage return connection portion 13c after the heat recovery.

The concentrate mixing module 400 mixes the concentrated PD fluid into the required formulation, and supplies the appropriately diluted PD fluid to the thermal control and sterilization module 300 for sterilization. The concentrate mixing module 400 also supplies detergent to the downstream module of the device and controls air exhaust from the fluid circuit while minimizing microbiological contamination.

The purified water is supplied from the thermal control and sterilization module 300 to the concentrate mixing module 400 via the mixed water supply connection 4a and the chemically controlled PD fluid is delivered to the mixing module output connection 4b, 0.0 > 300 < / RTI > The concentrate mixing module 400 is provided with an air outlet connection 6 to the atmosphere which enables filling and draining of the fluid system and a mixed module drainage 6 used to supply water at the disinfection temperature to the drain module 500 The connection portion 15 is also provided. The water at the disinfection temperature is also supplied to the water preparation module 200 through the reverse osmosis membrane disinfection connection 3.

The PD fluid is directed from the concentrated component of the PD fluid provided in the disposable concentrate container 402 which is connected to the manifold 404 of the concentrate mixing module 400 and is surrounded by the manifold cap 406, (400).

Now referring to the draining module 500, this module controls the flow of fluid to the outer waste connection 16 and is required to drain the dialysate (the fluid removed from the patient at the end of the PD treatment) To provide a negative pressure. The external waste connection 16 may be permanently connected to the household sewage system or may be temporarily connected, such as being clipped over a lavatory bowl. The drain module 500 also closes the drain line to isolate the fluid system as needed and stop the flow from the water preparation module to enable disinfection. The maximum flow rate to the external waste connection 16 is 3 L / min. And the maximum temperature of the fluid through the external waste connection 16 is 85 ° C.

Most of the connections to the drain module 500 have been described with respect to other modules of the device. In the following, the remaining connections to the cycler and sterilizable connector module 600 are described.

The cycler and sterilizable connector module 600 prevents the delivery of PD fluid of an unsafe chemical composition, temperature or pressure, or non-brittle PD fluid to the patient 50 by closing the appropriate supply line. As described above, the cyclic and sterilizable connector module 600 is connected to the thermal control and sterilization module 300 through the sterile fluid connection 8a, sterilization output connection 8b, and sterile fluid return connection 8c have. The cyclic and sterilizable connector module 600 is connected to the patient 50 via a patient inlet connection 9a and a patient drain connection 9b. The patient connections 9a and 9b are connected to a standard connector on a catheter (not shown) that is replaced by the patient 50 and introduced into the patient ' s submerged membrane at the beginning of each PD treatment period, . The disposable fluid line 10 is provided to the patient in a pre-sterilized, aseptic package. The disposable fluid line 10, which may be seen in Figures 19-21, is provided with a puncturable membrane 634 at the end connected to the cyclic and sterilizable connector module 600, 654 with a cap (not shown) to maintain sterility of the fluid line until disposable fluid line 10 is used.

The cyclic and sterilizable connector module 600 is configured such that fluid circuitry from the aseptic fluid connection 8a to the disinfection output connection 8b comprising a puncturable membrane 634 at the end of the disposable fluid line 10 is controlled by thermal control And disinfection module 300, as shown in FIG. The cycler and sterilizable connector module 600 maintains the sterility of the fluid circuit until the end of the treatment period once the membrane 634 on the fluid line 10 is punctured, To be sent.

The cyclic and sterilizable connector module 600 includes a negative pressure drain connection 14a to a drain module 500 for draining dialysate from the patient's multiple membrane steel and a dialysis connection from the cycler and sterilizable connector module 600, And a peripheral pressure drain connecting portion 14b used for discharging fluid other than water.

The sampling module 700 is connected to the disposable fluid line 10 via a sampling interface 11 and collects 15 ml of dialysis sample for analysis if requested. The sample represents the average composition of the dialysate drained over the entire cycle of the treatment period.

Hereinafter, the structure of each module will be described with reference to the drawings.

The water preparation module 200,

3 shows the structure of the water preparation module 200 in detail. The tap water coming from the main supply part of the home enters the water preparation module 200 through the tap connection part 1. The flow of water can be completely shut off by the inlet valve 202. The water passes from the inlet valve 202 through a 30 micron particulate filter 204 which protects the moving part of the water preparation module 200 from coarse particles in the water supply. The filter 204 also prevents the downstream components of the water preparation module 200, such as reverse osmosis membranes or particle filters, from being damaged or clogged.

The filtered water passes through a water softener 206, for example, in the form of an ion exchange column. The wastewater from the water softener 206 generated during the regeneration of the water softener 206 flows through the normally closed water softener valve 268, the purified waste water connection 2d, the heat discharge connection portion 13a of the heat control and sterilization module 300, And is sent to the drainage module 500. The water softener 206 protects the fluid components of the water preparation module 200, such as reverse osmosis membranes 238 and 252, from a limescale that may degrade the performance of these components. It is important that the reverse osmosis membrane (238, 252) operates so that the supplied water is softened to prevent accumulation of the lime scale.

The water treated water is in the form of a tank equipped with a float valve and is connected to an isolator (not shown) which reduces the pressure of the water from the main pressure to atmospheric pressure, The air from the isolator 208 is guided to the atmosphere from the isolator air outlet 17 which can be opened and closed by the isolator air discharge valve 209. The isolator 208 is also connected to the heat control and sterilization May receive air from module 300 and direct the air to heat control and sterilization module 300 through patient heat exchanger exhaust connection 2e.

On the downstream side of the isolator 208, a branch of the fluid path including the disinfecting cartridge 210 is connected to the main fluid path, which will be described in detail below. The treated water in the main fluid path is sent from the isolator 208 to the thermal control and sterilization module 300 through the cooling water output section 2a and through the cooling water return connection section 2b to the cooling purpose and preheating Is used at a controlled temperature of about 30 < 0 > C in the thermal control and sterilization module 300 before returning to the water preparation module 200 for the purposes of FIG. The elevated temperature of the water due to preheating within the thermal control and sterilization module 300 reduces the power required to pump water through the reverse osmosis membrane and improves the efficiency of the degassing operation described below.

The preheated water returning to the water preparation module 200 through the coolant return connection 2b passes through a series of components 214-224 which remove the dissolved gas from the water. These components are the proportional valve 214, the degassing throttle valve 216, the expansion chamber 218, the degassing pump 222, and the degassing chamber 224. In operation, water exiting the degassing chamber 224 is recirculated through the degassing throttle valve 216 via the proportional valve 214 by the degassing pump 222, which is a gear pump. The pressure drop of the water due to the degassing throttle valve 216 forces the gas dissolved in the water to forcibly escape from the solution and starts to form bubbles in the water. The pressure drop due to the degassing throttle valve 216 is a function of the flow rate through this valve because of the recirculation from the degassing chamber 224, Lt; / RTI >

The degassing chamber 224 includes a water level sensor 225 such as an ultrasonic level sensor for sensing the level of water in the chamber. When the water level in the degassing chamber 224 is lowered, the water level sensor 225 controls the water level in the degassing chamber 224 to be lower than the water level in the degassing chamber 224 until the water level in the degassing chamber 224 returns to the maximum water level. And controls the operation of the proportional valve 214 so that the proportional valve 214 is adjusted so that the water recirculated by the pump 222 can be replenished. The recirculated flow from the degassing chamber 224 is reduced to keep the flow through the degassing valve 216 constant. In this way, the water flow from the degassing chamber 224 toward the reverse osmosis membranes 238, 252 on the downstream side is replaced with the water flow of the same flow rate coming from the cooling water return connection portion 2b. However, due to the operation of the proportional valve 214, the flow rate from the degassing throttle valve 216 remains constant irrespective of the flow rate downstream from the degassing chamber 224. A constant flow rate of 900 ml / min through the degassing throttle valve 216 provides a pressure drop of 800 mbar (80 kPa), which is sufficient for effective degassing.

The depressurized water is sent from the degassing throttle valve 216 to the expansion chamber 218 which expands sufficiently to allow the bubbles initiated during rapid pressure reduction in the throttle valve to engage and have a time to increase in size It slows down. A portion of the bubble rises from the expansion chamber 218 to the surface of the water and forms a small gas head space within the expansion chamber 218. The expansion chamber is provided with a gas pipe 219 connecting the head space in the expansion chamber 218 between the fluid path between the expansion chamber 218 and the degassing pump 222, 222 in the fluid withdrawn from the expansion chamber 218. The mixture of gas and water is withdrawn from the expansion chamber 218 by a degassing pump 222 and the pressure of the water is regulated by a pressure sensor 220 for degassing to ensure that the pressure is low enough for effective degassing. Lt; / RTI > A degassing pump 222 pumps the gas and water into a degassing chamber 224 in which gas is evacuated to the isolator 208 at atmospheric pressure. The water level sensor 225 in the degassing chamber 224 may be used to remove water from the degassing chamber 224 if the water level is reduced due to the water being drawn from the degassing chamber 224 by the downstream components of the water preparation module 200, By controlling the flow of the fluid through the proportional valve 214 by opening the proportional valve 214 to increase the rate of flow through the degassing valve 216 directly from the coolant return connection 2b . In this way, continuity of the fluid in the subsequent portion of the water preparation module 200 is ensured.

A bypass from the upstream side of the proportional valve 214 to the degassing pressure sensor 220 is provided under the control of the degassing bypass valve 226 so that the pressure drop associated with the degassing throttle valve 216 Disinfection can occur without happening.

Degassed water from the degassing chamber 224 is introduced into the influent conductivity meter 228 by a reverse osmosis pump 236 (Model Procon 1608, available from Procon Products Div./Roehlen Industries, Ten) Which measures the conductivity of the water, along with the influent temperature sensor 230. The conductivity meter < / RTI > Each conductivity measurement of water (or PD fluid) by the apparatus 100 of the present invention is made by measuring the temperature since the measured conductivity of the solution varies with temperature. The conductivity measurement is compensated by a reference to the temperature taken to represent the concentration of ions in the water (or PD fluid).

After the conductivity measurement, the water passes through an activated carbon filter 232, which is passed through the activated carbon filter 232 at Gambraso, Sweden. K06735001, and the purpose of the filter is to remove free chlorine from the water and adsorb some organic contaminants. Chlorine in water can damage the membrane surface of the RO membranes 238 and 252.

Following the activated carbon filter 232, water passes through a 5 micron particulate filter 234, which is not captured by the first filter 204, and contaminates the reverse osmosis membrane of the units 238, 252 Remove any carbon or other particulate matter traces from the water.

The filtered water is passed through a first membrane surface of a reverse osmosis membrane unit 238 (Type HSRO / 2521 / FF sold by Dow Film Tech, USA) by a high pressure reverse osmosis pump 236, preferably a rotary vane pump , The first reverse osmosis output throttle valve 240 and the purifying waste connector 2d and the heat control and sterilization module 300 to the drain module 500. [ The high pressure of water passing over the surface of the membrane of the first RO membrane 238 overcomes the osmotic counterpressure caused by the ions in the retained liquid by reverse osmosis to form the reverse osmosis membrane unit 238, . The remaining water containing any impurities present in the water passes through the first reverse osmosis output throttle valve 240 and is sent to the cleaning waste connecting portion 2d. The first reverse osmosis output throttle valve 240 maintains pressure across the first membrane of the RO membrane 238 to ensure effective reverse osmosis.

A first reverse osmosis pressure differential sensor 242 is provided to detect the contamination of the first RO membrane 238 to detect influx into the first RO membrane unit 238 and waste stream from the unit The pressure difference between the first reverse osmosis output throttle valve 240 and the first reverse osmosis output throttle valve 240 is measured. When the membrane of the first RO membrane 238 begins to contaminate, the resistance of the membrane to the tangential flow between the inlet and the waste begins to increase. Because of the substantially constant flow fed from the reverse osmosis pump, the differential pressure is increased. If the pressure difference increases more than 0.5 Bar, it is detected by the differential pressure sensors 242a, 242b, and the membrane is considered to be contaminated. When the membrane of the reverse osmosis membrane unit 238 starts to be contaminated, the pressure drop across the membrane becomes larger, which is detected by the pressure sensors 242a and 242c.

The first reverse osmosis pressure differential sensor 242 is in the form of two cavities separated by a diaphragm where one cavity is defined as a one before the first reverse osmosis membrane unit 238, And the other cavity is in fluid communication with the post-osmosis membrane unit 238, as indicated by circles 242b, either before the first reverse osmosis output throttle valve 240 or as a circle 242c, 1 < / RTI > reverse osmosis membrane unit 238 of the present invention. The differential pressure is measured by monitoring that the diaphragm is deformed toward the cavity or other cavity. The control system need not measure the absolute pressure at the position of the first reverse osmosis pressure differential sensor 242a because only the differential pressure is required to detect contamination of the first salt osmotic membrane of the RO membrane.

The conductivity of the reverse osmosis water having passed through the first membrane of the reverse osmosis membrane unit 238 is measured by the first reverse osmosis conductivity meter 246 together with the first reverse osmosis water temperature sensor 248.

A first reverse osmosis membrane bypass valve 250 for use in disinfecting the water preparation module 200 is provided, the function of which will be described below.

A second reverse osmosis unit 252 (Type HSRO / 2521 / FF sold by Dow Film Tech, USA) is provided on the downstream side of the first RO unit 238. By using the two reverse osmosis membrane units 238 and 252, much higher purity water is provided than when only one membrane unit is used, and additional stability is provided even when one membrane ruptures. When measured in terms of conductivity, the first RO membrane 238 filters about 98% of impurities from the water pumped across the unit by a pump 236, and the second RO membrane 252 filters the remaining impurities 2 80% of the filtrate is filtered. The quality of the water required by the device 100 is very high and it may be difficult to achieve consistently with one reverse osmosis membrane. If one of the RO membranes 238, 252 is ruptured, the other membrane will be detected for contamination by the protection system and will continue to provide purified water for a short time before the apparatus 100 is stopped.

The wastewater from the second RO membrane 252 is recovered in the same manner as the first RO membrane unit 238 except that the wastewater is regenerated to the input of the reverse osmosis pump 236 via the disinfectant selector valve 256 And passes through the second reverse osmosis output throttle valve 254. This is because the wastewater from the second RO membrane 252 passes through the first RO membrane unit 238 and is already reasonably pure. The regeneration process improves the overall water consumption efficiency of the device of the present invention. Typically, during operation of the apparatus, a quantity of 750 ml / min. Is withdrawn from the degassing chamber 224 by the reverse osmosis pump 236. This flow rate is replenished with the quantity of 250 ml / min. Regenerated from the second ROE 252, and the quantity of 1000 ml / min. Is pumped toward the first ROE unit 238. The 500 ml / min. Of the 1000 ml / min. Water is passed through the cleaning waste connecting portion 2d and the 500 ml / min. Purified water is passed through the first reverse osmosis unit 238 to the second reverse osmosis unit 252, Lt; / RTI > A flow rate of 250 ml / min is passed through the membrane, passed through the purified water connecting section 2c, and a flow rate of 250 ml / min is further regenerated toward the input side of the first RO unit 238 in the second reverse osmosis membrane unit 252. [ do.

A second reverse osmosis pressure differential sensor 258 is provided to detect contamination by measuring the differential pressure between the influent and the effluent of the second RO unit 252. This operation is the same as that described above with respect to the first reverse osmosis pressure differential sensor 242 and the second reverse osmosis differential pressure sensor 258 has two cavities: a first cavity 258a and a second cavity 258b or 258c ).

In order to control the pressure of water supplied to the second RO exchanger 252 and to prevent the pressure from increasing as the output demand from the purified water connection 3c changes, the influent flow to the second RO unit 252, The reverse osmosis relief valve 260 is provided between the waste outlet streams from the two reverse osmosis membrane units. It should be noted that the output demand from the second ROE 252 changes from a full power, for example 250 ml / min., To a value of zero and a value in between in a given period. The relief valve 260 divides the water parallel to the throttle valve 254 so that the total amount of the total output of the first reverse osmosis membrane unit 258 Lt; / RTI > This action also reduces the consumption of water.

A second reverse osmosis conductivity meter 262 and a second reverse osmosis temperature sensor 264 are provided at the output of the second RO unit 252 to measure the conductivity of the output water, Lt; / RTI > An output water pressure sensor 266 is provided downstream of the second reverse osmosis temperature sensor 264 to measure the pressure of water output to the heat control and sterilization module 300 via the purified water connection 2c.

During disinfection of the water preparation module 200, the disinfectant selection valve 256 is opened to guide the waste stream from the second RO membrane 252 through the disinfection cartridge 210. The disinfection cartridge 210 contains a chemical disinfectant, such as an aqueous peracetic acid solution (a widely accepted disinfectant) that is diluted with water. During disinfection, the disinfecting valve 212 is opened, the main valve 202 is closed, and the flow through the cleaning waste connection 2d is prevented by the drain module 500. The float valve of the isolator 208 prevents any backflow through the water softener 206. The first reverse osmosis membrane bypass valve 250 is opened so that the wastewater coming from the first reverse osmosis membrane unit 238 is sent to the drainage module 500 through the purified wastes connection part 2d closed by the drainage module 500 And is returned to the output side of the first reverse osmosis membrane unit 238 rather than to the bottom. The degassing bypass valve 226 is opened to allow fluid to flow therethrough. Thus, it will be appreciated that a recirculating closed loop is formed so that the chemical disinfectant can circulate through the water preparation module 200. The closed loop disinfects most of the components and fluid paths of the water preparation module 200. The disinfectant select valve 256 is closed and the second reverse osmosis throttling valve 254 and the disinfectant select valve 256 are closed to disinfect the fluid path between the disinfectant select valve 256 and the reverse osmosis pump 236, The disinfectant fluid already present in the fluid channel is circulated through the disinfection selector valve 256 and through the reverse osmosis pump 236.

An additional recycle path from the gas output of the degassing chamber 224 through the isolator 208 and bypass valve 226 for degassing is provided so that the disinfecting fluid can circulate through the isolator 208 . The degassing bypass valve 226 is opened to allow fluid to flow through the valve so that the pressure of the disinfecting fluid is not reduced by the degassing throttle valve 216 because peracetic acid forms hydrogen peroxide So that the efficiency is lowered. Likewise, in the case of hot water disinfection, the drop in pressure through the degassing throttle valve 216 can boil the water. Even when the degassing bypass valve 226 is opened, a part of the disinfecting fluid still passes through the degassing throttle valve 216 to disinfect the fluid path.

Once all of the components downstream of the water softener 206 have been sterilized, the disinfectant fluid is sent to the drain module 500 through the clean waste connector 2d.

Water at the disinfection temperature is introduced into the output side of the second RO membrane through the reverse osmosis membrane disconnection connection part 3 to disinfect the components of the water preparation module downstream of the second RO membrane component 252.

In the case of thermal disinfection of the water preparation module 200 the disinfectant cartridge 210 is not required and the water can be sterilized by the thermal control and sterilization module 300 between the cooling water output 2a and the cooling water return connection 2b during disinfection, .

Thermal control and sterilization module (300)

Figure 4 shows the structure of the thermal control and sterilization module 300. Water from the cooling water output portion 2a of the water preparation module 200 is guided through the cleaned waste heat exchanger 324 in which water is discharged through the heat exhaust connection portion 13a through the cleaned waste heat exchanger 324, The water heated by the cleaning waste heat exchanger 324 is heated by the water electric heater 322 before exiting the cooling water return connection portion 2b , It is guaranteed to be maintained at the optimum operating temperature, usually 30 캜, for the water preparation module 200.

In the thermal control and sterilization module 300 the water is circulated in the normal manner via the patient output heat exchanger 314 and the recirculation throttle valve 310 by the patient output heat exchanger pump 316 in the form of a gear pump. The patient output heat exchanger 314 is in the form of a water tank through which fluid is passed through a conduit sealed from an on-line autoclave 375 (described below). The water bath is maintained at a constant temperature by recirculating water to maintain the PD fluid sent to the patient at the required delivery temperature. If the temperature of the recirculating water is too high, the patient output heat exchanger drain valve 318 is opened such that the heated water flows from the patient output heat exchanger 314 to the patient output heat exchanger drain throttling valve 308 and the water heater 322 To the cooling water return connection portion 2b. A corresponding amount of low temperature water is withdrawn from the cooling water output 2a of the water preparation module 200 by the patient output heat exchanger pump 316 until the temperature of the heating bath of the patient output heat exchanger 314 is reduced to a desired level .

The patient output heat exchanger 314 is connected to the patient output heat exchanger drain valve 318 and the air bleed valve (s) 318, for example, when it is not desirable to extract heat from the patient output, 320) by releasing the gravity. Air flows from the isolator 208 through the open air bleed valve 320 and the air bleed throttle valve 312 to the patient output heat exchanger exhaust connection 2e and into the patient output heat exchanger 314. [ When the patient output side heat exchanger 314 is filled with air rather than water, negligible heat is transferred to or from the patient output fluid. In this case, the patient output heat exchanger pump 316 is brought to an inoperative state. The patient output heat exchanger 314 opens the air bleed valve 320 to discharge the air and recharges the patient output heat exchanger pump 316 again with the patient output heat exchanger drain valve 318 closed do.

The purified water generated by the water preparation module 200 is sent to the thermal control and sterilization module 300 through the purified water connection 2c. The purified water passes through the disinfection heat exchanger 326 used during the disinfection of the concentrate mixing module 400 to preheat the purified water by recovering the heat passing through the heat recovery drain connecting portion 13c from the heat recovery drain connecting portion 13b . The preheated water exiting the sterilization heat exchanger (326) is heated to the disinfection temperature by an electric sterilization heater (330). During normal operation of the apparatus, the disinfection heater 330 is used to control the temperature of water exiting the mixed water supply connection 4a toward the concentrate mixing module 400. [

During the disinfection of the drain module 500, the water coming out of the purified water connection portion 2c bypasses the disinfection heat exchanger 326 through the disinfection heat exchanger bypass valve 328 and exits the heat recovery drain return connection portion 13c Outgoing water remains at a disinfection temperature of 85 ° C. The disinfection heat exchanger bypass valve 328 is only used during disinfection of the drain module 500.

The PD fluid produced by the concentrate mixing module 400 is sent to the thermal control and sterilization module 300 through the mixing module output connection 4b. This fluid passes through an input volumetric flow meter 350 which records the flow of PD fluid entering the patient. The PD fluid is withdrawn by gear type volume pump 352, which is monitored by a tachometer 354 to ensure that the pump operates at the expected volumetric flow rate. The feed rate of the volume pump 352 is also monitored independently by the input welding flow meter 350 to ensure correct operation. The volume pump 352 is operated at a flow rate and pressure necessary for on-line autoclave, that is, 300 ml / min. And an absolute pressure of 6 bar (600 kPa) to prevent the fluid from boiling at < RTI ID = 0.0 > 150 C. < / RTI > A gear type pump was selected which ensures that water passing through the on-line autoclave 375 can be compressed by the pump to the required pressure for the water heated to the sterilization temperature.

During normal operation of the apparatus 100, the PD fluid enters the OLA 375 via an on-line autoclave (OLA) input valve 356. At this point, the pressure of the PD fluid is monitored by two independent OLA pressure sensors 358. One of the OLA pressure sensors 358 provides a pressure to be read to the control system for the device and the other sensor provides pressure to be read to a separate protection system (see FIG. 1) It prevents the patient's safety from being damaged. Both the pressure sensor, the temperature sensor and the conductivity sensor, which are configured to monitor patient safety critical variables in the system, are dual-placed in this manner so that the patient can be assured of the safety of each patient Safety measures are also double-checked independently.

On the downstream side of the OLA pressure sensor 358, the PD fluid passes through a first OLA heat exchanger 360 and a second OLA heat exchanger 362, which are connected to an OLA heating tank 364, Thereby preheating the PD fluid entering the OLA heating tank 364. The heat of the PD fluid entering the OLA heating tank 364 is then preheated. The OLA heating tank 364 is an oil heating tank heated by an electric heater 365 and is provided with a recirculation pump 366 (gear pump) and a heating tank temperature sensor 368. The oil or ethylene glycol is circulated by the recirculation pump 366 through the heating oil body tank 367 including the oil bath and the PD fluid (or water) passes through the sterilizing oil tank 369. The heating oil body tank 367 and the sterilizing oil tank 369 are separated by a thermally conductive barrier.

To ensure that the liquid leaving the OLA heating tank 364 is aseptic, an algorithm may be used that represents a sterilization value for the sanitizing process, e.g., an algorithm that models the temperature distribution within the OLA heating tank 364, (Tin) of the liquid to be sterilized entering the OLA heating tank 364, the temperature (T _in ) of the liquid to be sterilized _{in the} OLA heating tank 364 A variable that can be calculated from the temperature (T _Hin ) of the liquid (ethylene glycol) is defined. Since the temperature at the outlet of the OLA heating tank 364 (the temperature of the heating liquid and the temperature of the sterilized liquid) is linked to the temperature at the inlet of the OLA heating tank 364, the OLA heating tank 364 It is also possible to consider the temperature T _out of the sterilized liquid leaving the OLA heating tank 364 and / or the temperature T _Hout of the heating liquid leaving the OLA heating tank 364.

If a variable representing the sterilization value for the sterilization treatment is defined, then the value set for this variable, i.e., sufficiently large to correspond to the efficient sterilization of the liquid, and if such a liquid is thermally sensitive (such as in the case of a solution for peritoneal dialysis containing glucose) The lowest possible value is selected in order to prevent or limit deterioration of the liquid to be sterilized.

In operation, the control system of the apparatus 100 controls the temperature and flow rate measured by the OLA temperature sensor 370, the heating bath temperature sensor 368 and the input volumetric flow meter 350, the temperature within the OLA heating bath 364 From the distribution algorithm, the variable values representing the sterilization value for the treatment at regular intervals. Each time a new value for the variable is calculated, the control system checks whether the calculated value is greater than the set value to confirm that the liquid is aseptic. An additional temperature sensor 379 is used to obtain the temperature of the liquid sterilized by the OLA before entering the heat exchanger.

The checking process that allows for effective sterilization of the liquid can be passive. This is because, if the aseptic condition is an important characteristic of the PD fluid, the selection of the flow rate for the liquid to be sterilized is limited to a limited number of predetermined different values (e.g., three) The standard operating mode for the pre-established OLA 375 as a function of the predetermined flow rate can be implemented, so that the operating function of the mechanism is simplified as much as possible. In this case, the checking procedure described above is used merely to confirm that the sterilization process is effective.

An operating mode for the OLA 375 that can freely select the flow rate of the liquid to be sterilized within a predetermined range of values may be implemented. In such a case, the control system determines, from the set values for the variables representing the selected flow rate and the sterilization value, the temperature of the heating fluid such as that measured by the temperature sensor 368, . During operation, the control system regularly adjusts the flow rate of the volume pump 352 and / or the temperature of the heating liquid calculated by the recirculation pump 366, so that the calculated value of the variable is always greater than the set value.

Variables denoted by F ₀ (expressed in minutes) in the literature (see page 288 of European Pharmacopoeia 1997 or page 1977 of the United States Pharmacopoeia 23 edition) are used as a variable representing the sterilization value for the sterilization treatment. F ₀ is the sum of the cumulative germicidal effects during the sterilization treatment or the sterilization value F when the reference temperature T is 250 ℉ (121.1 캜) and the thermal inactivation value (Z) is 18 ℉ (10 캜) ^Z _T ). The deactivation temperature value Z is a temperature increase that is doubled by 10 times the destruction rate of a particular microorganism. Z = 10 ° C corresponds to a theoretical microorganism ( Bacillus stearothermophilus ) that is slightly more resistant than a microorganism thought to be more thermally resistant than any other spore forming microorganism. The basic formula for F ₀ is expressed by the following equation (1).

The above formula requires that the liquid to be sterilized is permanently flowing and that the heating means used to increase the temperature of the liquid to be sterilized does not make the temperature of the liquid equal at all points in the heating chamber Can not be applied directly.

When the heating means is arranged to heat the liquid to be sterilized along a part of the pipe through which the liquid is circulated, F ₀ can be calculated using the formula shown in Equation (2).

In Equation (2)

L: length of the sterilizing fluid path 369 of the liquid to be sterilized through the OLA heating tank 364

S: Internal cross sectional area of the sterilization fluid path 369 through the OLA heating tank 364

Q: The flow rate of the liquid to be sterilized through the OLA heating tank (364)

T (y) is a temperature distribution formula of the liquid as a function of the distance from the inlet of the OLA heating tank 364.

The above equation [T (y)] depends on the structure of the OLA heating tank 364 and its operating mode. For example, FIG. 8 shows a first example of a heat exchanger adapted for use in an OLA 375. This heat exchanger consists of two concentric pipes, the outer pipe forming a sleeve around the inner pipe. A sterilization fluid path 369 is provided by the interior of the inner pipe and a heating fluid path 367 is provided between the inner and outer pipes.

During operation, the liquid to be sterilized and the heating liquid, such as ethylene glycol, is circulated in the opposite direction in the inner pipe (sterile fluid path 369) and the outer pipe (thermal fluid path 367). The inner diameter of the sterilization fluid path 369 is selected so that the flow of the liquid to be sterilized is always turbulent within a flow range (100-400 ml / min.) Comprising the flow rate for the OLA 275 operation.

The equation for T (y) can be expressed by Equation (3) for a stainless steel inner pipe and a copper outer pipe, and for a heat exchanger of the dimensions set forth in Table 1.

Length (cm) 222 Inner pipe volume (ml) 26 External pipe volume (ml) 105 Cross-sectional area of the inner pipe (cm ² ) 0.117 The area of the annular space between the inner pipe and the outer pipe (cm ² ) 0.502 The inner circumference of the inner pipe (cm) 1.213 Outer periphery of inner pipe (cm) 1.995 Inner exchange area of inner pipe (cm ² ) 269 Outside exchange area of inner pipe (cm ² ) 443

T _in : the temperature of the liquid to be sterilized to enter the sterilization fluid path 369

T _Hin : the temperature of the heating liquid (as measured by the heating bath temperature sensor 368) entering the heating fluid path 367

r = 6 x 10 ^-3 x Q ² - 0.0577 Q + 19.084

Q: Flow rate of liquid in sterilization fluid path 369

As can be seen from this example, a measurement of the temperature (T _in ) of the liquid to be sterilized to enter the OLA heating tank 364, a measurement of the temperature of the heating liquid (T _Hin ) entering the OLA heating tank 364, The sterilization value F ₀ can be calculated at any time from the equation for modeling the measured value of the flow rate Q of the liquid to be sterilized and the temperature distribution inside the OLA heating tank 364. [

In the preferred embodiment of the present invention, as shown in Fig. 4, the OLA heating tank recirculates ethylene glycol by a recirculation pump 366 to ensure a uniform temperature throughout the OLA heating tank 364, Gt; (ethylene glycol) < / RTI > The sterilization fluid path 369 passes through the OLA heating tank 364 within the sealed conduit. However, the above-described principle can be applied to the illustrated embodiment.

Over all operating states of the OLA 375 where the OLA 375 is expected to produce a sterile fluid (water or PD fluid), the control system determines that the calculated sterilization value F ₀ corresponds to the asepticity of the liquid _Lt ; / _RTI > is always greater than the first threshold ( _F0min1 ) for the sterilization process.

The OLA heating tank 364 heats the PD fluid to a temperature of 150 ° C or higher and maintains the PD fluid at this temperature for at least 2 seconds to autoclave the PD fluid to ensure sterility. The flow rate through the OLA heating tank 364 is 300 ml / min. Under these conditions, the corresponding theoretical F ₀ value is considered to be at least 20 minutes.

The temperature of the aseptic PD fluid exiting the OLA heating tank 364 is checked by two independent OLA temperature sensors 370 that ensure that the required temperature has been reached. Most of the heat from the autoclaved PD fluid is recovered by the first and second OLA heat exchangers 360, 362 to the PD fluid entering the OLA heater. The remaining heat is recovered in the patient output heat exchanger 314 to ensure that the temperature is acceptable to the patient, i.e., 37 ° C. The temperature of the autoclaved PD fluid is checked on the downstream side of the patient output heat exchanger 314 by two independent patient output temperature sensors 372. Finally, the pressure of the PD fluid is reduced by the patient output pressure relief valve 374 to a pressure that is safe to send to the patient. Next, the autoclaved, pressure and temperature controlled PD fluid is sent to the cyclic and sterilizable connector module 600 through the aseptic fluid connection 8a.

During sterilization of the cyclic and sterilizable connector module 600, the fluid pumped by the volume pump 352 takes a different path through the OLA to be at a temperature of 137 ° C rather than 37 ° C. The fluid is maintained at an absolute pressure of 3 bar (300 kPa) to prevent boiling. In this case, the fluid passes through the OLA sterilization valve 376 and the sterile heat exchanger 378, which is supplied from the sterilizing output connection 8b of the cyclic and sterilizable connector module 600 to the sterile fluid return connection 8c, To recover heat. Heat recovered by the germicidal heat exchanger 378 is used to preheat the fluid, which is then sent to the second OLA heat exchanger 362 for further preheat. Heating of the sterilization fluid by the OLA heating tank 364 is similar to the process for autoclaving the PD fluid. However, the heat is only recovered by the second OLA heat exchanger 362, not the first OLA heat exchanger 360 or the patient output heat exchanger 314. [ The patient output heat exchanger 314 is drained at this stage to contain only air that is not good as a heat conductor and therefore does not transfer a significant amount of heat from the sterilization fluid. Once the fluid at the heat receiving side of the first OLA heat exchanger 360 reaches the temperature of the fluid on the heat transfer side, the OLA input valve 356 is closed and thus the heat is received by the first OLA heat exchanger 360 There is no flow through the heat receiving side of the first OLA heat exchanger 360. [ Even though there is no flow, the fluid at the heat receiving side of the first OLA heat exchanger 360 is not boiled because it is in fluid communication with the fluid flow through the OLA heater 364 and therefore at the same pressure. Thus, the temperature of the sterile fluid exiting the sterile fluid connection 8a is 130 ° C, which is much higher than the fluid provided to the patient, and is therefore suitable for sterilizing the cycler and sterilizable connector module 600.

Between the clutch and disinfection sterilization of possible connector module 600, OLA any point, the minimum period by the sterile fluid in the fluid conduit on the downstream side of the heating tank (364) (t _2), the minimum temperature during the (T ₂ ), The period and temperature correspond to a second set sterilization value ( _F0min2 ), which is given by the following equation (4).

Sterilization of the fluid circuit is simply to check that the temperature of the liquid measured by the patient output temperature sensor 372 is constant above T ₂ during at least the same uninterrupted interval as t ₂ , .

Since the sterilization of the cyclic and sterilizable connector module 600 is performed with sterile water, the control system must identify both sterilization of the liquid and sterilization of the fluid circuit. That is, the control system is to be checked if it is greater than the sterilization value F _0min2 for sterilization treatment is sterilization value for a sterilization treatment is applied to the liquid is greater than F _0min1, it applied to the fluid circuit. For this reason, the temperature of the aseptic liquid is increased from the fluid sterilization temperature of 150 DEG C (required to achieve _F0min1 ) to the fluid circuit sterilization temperature of 130 DEG C [which is lower than 150 DEG C, The required pressure in the second OLA heat exchanger 600 is an absolute pressure of 3 bar rather than an absolute pressure of 6 bar), the second OLA heat exchanger 362 is used.

The patient output pressure relief valve 374 is used to maintain the fluid in the front of the relief valve 374 at a high absolute pressure of 6 bar and during sterilization to prevent the fluid after the relief valve from boiling at < RTI ID = 0.0 > 130 C ≪ / RTI > Those skilled in the art will recognize how to configure such a valve. If the water starts to boil, it is not possible to verify the effectiveness of the sterilization treatment of the circuit, since it is not possible to ascertain whether all points of the fluid circuit have been in contact with water for a minimum period of time that is uninterrupted.

The fluid path of the device 100 must be carefully insulated to prevent heat loss during disinfection and / or sterilization. In particular, the relative positions of the hot components are chosen such that heat loss is kept to a minimum, i. E. Ensuring that the adjacent components are kept warm to each other. In this way, it is ensured that the fluid path is maintained at the correct disinfection, i.e. sterilization temperature, throughout the path. The temperature sensor 380 disposed at the connection portion 8b may be used to confirm the sterility of the fluid circuit leading to the heat exchanger 378. [

In one embodiment, the heat exchangers 360, 362, 378 may be formed as shown in FIG. 9, that is, a heat exchanger having a junction at a portion of the heating pipe and the entire length of the fluid pipe. The two parts of the combined pipe are formed so as to form a coil provided with a combined helical part, and the inner and outer sides of the cylinder thus formed are covered with a material having high thermal conductivity.

Other details of the thermal control and sterilization module 300 are described in the Gambro Reference HP 1310 application entitled " Method and Apparatus for Disinfecting and Distributing Medical Applications Liquid ", which application is incorporated herein by reference And attach a copy thereof.

The concentrate mixing module (400)

5 shows the structure of the concentrate mixing module 400 in detail. The concentrate mixing module 400 includes a disposable concentrate container 402 that interfaces with the manifold 404 and is covered by a manifold cap 406. The disposable concentrate container 402 includes a chamber that includes a compartment 408 for the aqueous solution of lactic acid, a compartment for the detergent 410 (e.g., powdered sodium carbonate), a compartment for the powdered sodium bicarbonate 412 ), A powdered sodium chloride chamber 414, a pulverized calcium chloride formulation 416, a powdered magnesium chloride chamber 418, and a powdered glucose compartment 420. The disposable concentrate container 402 contains enough material in each compartment for the PD treatment period of the patient according to the prescription selected during many prescriptions.

The composition range for each component of the PD fluid that can be dispensed to the patient and stored in the disposable concentrate container 402 is shown in Table 2 along with the composition range for sodium lactate formed from lactic acid and sodium bicarbonate. The mass of the components in the disposable concentrate container 402 and the approximate volume of each compartment 408-420 are also given in Table 2.

The sodium concentration in the PD fluid delivered to the patient is within ± 2.5% of the required amount. The concentrations of the other components are within ± 5% of the required amount. It is assumed that the filling volume is at least 1 liter. For any given prescription, at least one component of the dialysis fluid in the container 402 will not be consumed completely because these amounts are selected to encompass a wide range of prescriptions.

Apart from or in addition to the ingredients shown in Table 2, other ingredients such as potassium salts may be included.

ingredient Composition range Mass in the compartment The approximate volume of the compartment Sodium chloride 120-140 mmol / l 208 g 300 ml Magnesium chloride 0.20-0.50 mmol / l 36 g 150 ml Calcium chloride 1.0 to 2.0 mmol / l 52 g 300 ml Sodium lactate 0 to 40 mmol / l * - - Sodium bicarbonate 0 to 40 mmol / l * 120 g 150 ml Lactic acid A range compatible with sodium lactate and sodium bicarbonate levels 120 g 300 ml Glucose 1.5 to 4.0% w / w 1176 g 1800 ml Sodium carbonate - 20 150 ml Note: "For a given solution, the molar concentration of sodium lactate and sodium bicarbonate is increased by up to 30 to 40 mol / l.

It should be noted that the relative arrangement, that is, the order of the compartments 408-420 in FIG. 5 (and FIG. 5A) is only schematic and does not represent any physical order, but is chosen to readily indicate the form of the fluid system . Figures 10 and 11 illustrate the sequence of compartments 408-420 in the disposable concentrate container 402 in accordance with one embodiment of the present invention.

FIG. 10 shows the structure of the disposable concentrate container 402. The compartments 408-420 are individually injection molded into polypropylene and mounted to the chassis 401 at the lower end. The upper ends of the compartments 408-420 are held together by a lid 403 which also serves to close the upper end of the glucose compartment 420 and provide the container 402 with a handle. As is apparent from Table 2, the lactic acid compartment 408, the sodium chloride compartment 414, and the calcium chloride compartment 416 are each about 2 volts of the volume of the cleanser compartment 410, the sodium bicarbonate compartment 412 or the magnesium chloride compartment 418, It is a ship. The glucose compartment 420 is significantly larger than the other compartments 408-418. At the lower end of each compartment 408-418 is provided at least one connector 407 for connection to the manifold 404.

Figure 11 is a partial cross-sectional view of the disposable concentrate container 402 with a portion of the chassis 401 removed, clearly showing the connector 407 of the compartments 408-420. The glucose compartment 420 is provided with two connectors 407a and 407b, the function of which will be described below.

12A to 12C show the lid 403 (FIG. 12A), the glucose compartment 420 (FIG. 12B) and the chassis 401 (FIG. 12C) of the disposable container 402. 12A to 12C, the lower side of the glucose compartment 420 is inclined to guide the glucose powder in the compartment 420 toward the input connector 407a. The connectors 407 of the respective compartments 408 to 420 are accommodated in corresponding holes 409 formed in the chassis 401. The holes 409 are aligned in the longitudinal direction of the chassis 401 along a line A that is biased at a predetermined distance from the longitudinal axis of symmetry B of the chassis 401. In this way, the container 402 is manufactured rotationally asymmetrically so that it can not be inserted into the device 100 conversely.

The compartments 408 to 418 are snapped in place and the glucose compartments 420 are thermally riveted to the chassis 401 using rivets 411 formed integrally with the compartments . The rivet 411 is accommodated in the corresponding hole 405 of the chassis 401. Further, the rivets 411 of the compartments 408 to 418 may be riveted at a high temperature.

The chassis 401 includes a skirt 413 that is wrinkled for strength and protects the connector 407 when the container 402 is disposed on the surface. The skirt or connector may be provided with a removable strip 443 for protecting the connector 407 during transport and storage.

Figure 13 shows magnesium chloride compartment 418 as an example of a smaller sized compartment 410, 412, 418. FIG. 14 shows a sodium chloride compartment 414 as one example of a larger size compartment 408, 414, 416. The lower sides of the compartments 410, 412, 418 and 408, 414 and 416 of each dimension are inclined toward the connector 407 such that the powder (or liquid) in the compartments 408 to 418 faces the connector. Each compartment 408-418 is provided with a compartment lid 415 that fits into compartments 408-418 after each compartment is filled with each powder or liquid. In this way, it is not necessary to charge the containers 408-418 through a charge, that is, a narrow connector 408, which may be difficult. The compartment lid 415 is heat welded (hot fusion) to each compartment 408-418. As described above, the container lid 403 also closes the glucose compartment 420 and forms a lid that is thermally welded to the compartment.

Referring again to FIG. 5, a new disposable concentrate container 402 is connected to the manifold 404 after the start and disinfection of the PD treatment period, and once the treatment is terminated, the connection is released and discarded. The connection motor 422 engages the disposable concentrate container 402 and drives the container to be connected to the manifold 404.

Functionally, compartments 408-420 of the disposable concentrate container 402 are of three types. The first embodiment includes a lactic acid compartment 408, a cleanser compartment 410, a calcium chloride compartment 416, and a magnesium chloride compartment 418. This first type of compartment includes an air discharge channel 424 extending from the upper region of the interior of the compartment to the direct opening into the atmosphere when the compartments 408, 410, 416, 418 are connected to the manifold 404 have. Air discharge channels 424 allow air to flow through the compartments 408, 410, 416, 418 when water is introduced into the compartments through the fluid channels 426 of this kind of vessel or when the fluids are drawn out of the compartments 408, To be able to escape. The fluid channel 426 introduces fluid into the lower region inside compartments 408, 410, 416, 418 such that the water contacts all material as the water level rises up to the compartment.

The first type of compartments 408, 410, 416, 418 are used to contain the powdered salt required only in small amounts so that the salt can be included in an amount that is completely soluble without further fluctuations when a sufficient amount of water is introduced into the compartment Or used for salts already in concentrated solution.

The second type of compartments 412 and 414 are used for the salt required in such a large volume that the compartments 412 and 414 must be large enough to contain all of the water necessary to dissolve all of the necessary salts at one time. Thus, compartment 412 contains sodium bicarbonate and compartment 414 contains sodium chloride. This type of compartment includes a combined air outlet and a priming and output channel 430 in combination with a fluid channel 428. In this type of compartment 412, 414 the salt is initially dipped (or primed) by introducing water through the combined priming and output channels 430 in the lower region of the compartment and air is drawn from the upper region of the compartment And is drained through the combined air discharge and fluid channel 428. By the priming operation, the compartments 412 and 414 are filled with water so that all the salts are immersed therein. A similar technique to EP-A-0278100 which is incorporated herein is disclosed.

Once the salt is fully wetted, the water is drawn through the combined air exhaust and fluid channel 428 and seeps to dissolve the salt, so that the salt solution flows through the combined priming and output channels 430 into the compartments 412, As shown in FIG. As the salt solution is withdrawn from the compartments 412 and 414, a reduction in pressure causes the combined volume of water to be connected to the water source and to the compartments 412 and 414 via the fluid channel 428 I go in.

The second type of compartments 412, 414 may be operated in a manner similar to the compartments 408, 410, 416, 418 of the first type. For example, the compartment may be filled with water through the output channel 430 to dissolve the salt therein, and a (substantially saturated) salt solution may be drawn through the output channel 430. Because the amount of salt in the second type of compartments 412, 414 is greater than that which can be dissolved by the volume of water that fills the compartments 412, 414, some of the salt remains in the compartments 412, 414 after the solution is withdrawn. Thus, the compartments 412, 414 can be recharged with water to obtain more solution.

The physical configuration of the compartments of the first and second embodiments is the same when the vessel 402 is not connected to the manifold 404. Determining the shape of the compartment is the compartment content of the mixing module 400, the arrangement of the valve and air outlet.

The third type of compartment is the glucose compartment 420. Glucose is particularly difficult to dissolve consistently and quickly at high concentrations, such as 50%, and therefore recirculation is required to ensure that all glucose is dissolved. Also, the volume of the glucose solution decreases as the glucose dissolves, so that the glucose compartment 420 requires continuous drainage throughout the dissolution process. The glucose compartment 420 thus comprises a glucose air outlet channel 432 permanently connected to the atmosphere when the disposable concentrate container 402 is connected to the manifold 404 and a water or recirculated glucose solution, A fluid input channel 434 for input into the lower region of the glucose compartment 420 and a glucose particle filter 438 for preventing the glucose particles from entering the fluid system by accident And a glucose output channel 436.

The present inventors have found that monohydrate glucose, especially LYCADEX PF / Dextrose mono pyrogen from Roquette Freres SA, located in Lestrem, France, is used to obtain good results, Glucose is available in the amounts required by European Pharmacopoeia 1997 and is relatively inexpensive. In addition, the present inventors have found that when water is added to anhydrous glucose, the anhydrous glucose forms a cake that prevents effective dissolution. Particles of relatively large size are considered to be advantageous in terms of effective dissolution since they improve flowability and cause less caking.

Figure 15 is a cross-sectional view showing the lower portion of the glucose compartment 420 of the disposable concentrate container 402 in place on the manifold 404 when the container 402 is mounted into the device 100 The lid 406, and the manifold 404, respectively. The container 402 is mounted within the apparatus 100 by horizontally sliding the container along a pair of container support rails 417. The container support rail 417 engages the protrusion 419 on the container 402 connector 407 to keep the container 402 in a vertical position. The container support rail 417 is vertically driven by the connection motor 422 (see FIG. 5) to lift the container 402 up and down. When the disposable concentrate container 402 is loaded into the apparatus 100, the lid 406 closes the manifold 404 to open the manifold 404 ≪ / RTI > is prevented from being contaminated by external contaminants. Once the container 402 is mounted into the apparatus 100, the connecting motor 422 acts to drive the container 402 downward over the lid 406 via the container support rail 417, ) On the manifold 404 in place.

As shown in FIG. 15, there is a drain port 441 in the manifold 404, through which fluid may be discharged to the storage drain disinfection valve 498, as described below.

15, the connector 407 includes an insertion portion (not shown) for holding a silicone rubber or thermoplastic elastomer diaphragm 423 fitted in the neck portion of the compartment 420 and sealing the compartment 420 during storage 421). The insertion portion 421 includes a protrusion 419 (a part thereof) that engages with the container supporting rail 417 and is welded into the neck portion of the compartment 420. The connectors 407 of the respective compartments 408 to 420 are all configured in the same manner.

In the compartment 420, the central pipe 425 reaches the uppermost part of the compartment 420, which is not shown in Fig. Each compartment 408-420 includes an air outlet channel 424, a combined air outlet and fluid channel 428, a glucose output channel 436 or a glucose air outlet channel 432, depending on the particular compartment 408-420. (Not shown).

The center pipe 425 may be received within an annular protrusion from the compartment lid 415 at its upper end (not shown), which has a larger diameter than the central pipe 425 and surrounds the central pipe 425 The spacing between the annular projection and the wall of the central pipe 425 may serve as a filter.

Alternatively, the central pipe 425 may be provided with an injection molded filter element 439 as shown in FIG.

Between the base of the central pipe 425 and the inclined bottom of the compartment 420 a series of spaced bar shaped diffusers 427 extending from the central pipe 425 to the bottom of the compartment 420 are provided. The diffuser 427 is shown in greater detail in FIG. The diffuser 427 supports the central pipe 425 within the compartment 420 and also diffuses the water flow (or other fluid) into the compartment 420 so that the flow is turbulent, (Or glucose) in the solution to aid dissolution. When the turbulent water stream dissolves the powder in the region of the diffuser 427, the remaining powder falls into the compartment 420, and all the powder dissolves.

Generally, each compartment 408-420 is configured in this manner. In one possible configuration (not shown), the glucose compartment 420 has a tapered side that prevents the glucose powder in the compartment from rising when water is added extending outward in the upward direction. If the powder tends to rise, a number of channels are formed on the periphery of the compartment. The water dissolves the powder in this region, and the powder falls to seal the channel.

As shown in FIG. 15, the manifold 404 includes spikes 429 for each connector 407. Spike 429 is disposed to rupture diaphragm 423 to provide fluid communication between manifold 404 and compartment 420. The spikes 429 are removably disposed within the manifold 404 and are replaceable when worn by continuous diaphragm drilling.

Inside the spike 429 is formed a central fluid channel 431 connected to the central pipe 425 of the compartment 420 (see FIG. 17). Additional fluid channels 433 are formed in the spikes 429 to fluidly communicate with the interior of the compartment 420 through the diffuser 427 when the container 402 is installed in the manifold 404. Thus, the central fluid channel 431 and the central pipe 425 form a combined fluid channel concentric with the fluid channel formed by the neck portion of the connector 407. 15 is connected to the sodium bicarbonate compartment 412 and the sodium chloride compartment 414 and is also connected to the first connector 407a of the glucose compartment 420 to provide fluid input channels 434 and And is used to form the glucose output channel 436.

An alternate spike 429a is shown in FIG. In this type of spike 429a, the central fluid channel 431a directly connects the central pipe 425 of the compartment 418 to the atmosphere so that the central pipe 425 acts as an air outlet. This type of spike is used to couple the lactic acid compartment 408, the cleanser compartment 410, the chloride chloride compartment 416 and the magnesium chloride compartment 418 to the manifold and also to the second connector of the glucose compartment 420 407b so as to form a glucose air outlet channel 432. [

18, the cap 406 includes a lid 435 which is adapted to receive the spike 429a when the cap 406 is in place for disinfection of the device 100. [ Is fitted up. The lid portion 435 changes the flow of disinfectant fluid from the additional fluid channel 433 into the central fluid channel 431a so that the central fluid channel 431a is disinfected. Without the cover 435, it would not be possible to route the disinfecting fluid through the additional fluid channel 433 to the central fluid channel 431a.

16 shows the manifold cap 406 removed from the manifold 404. To achieve this, from the position shown in Fig. 15, the container 402 is lifted by the container support rail 417 so that the cap 406 can be pivoted to the position shown in Fig. The cap 406 is attached to the manifold 404 by a spring biased hinge 437 that ensures that the last portion of the cap movement that moves over the manifold 404 is more linear than the rotation, A small DC motor (not shown) within the hinge 437 provides movement power to move the cap 406 in and out of the manifold 404 Position. Alternatively, a spring mechanism may be used.

Figure 17 shows the container 402 in place on the manifold 404 where the diaphragm 423 is broken by the spikes 429.

Figures 24 and 25 illustrate other configurations of the compartment, e.g., compartment 408 or 418. [ Hereinafter, the compartment 408 will be described. This configuration differs from the structure described with reference to Figs. 13 to 18 mainly in the configuration of the air discharge channel 424 and the fluid channel 426. Fig.

The neck portion of the compartment 408 includes an insert 542 with a film 545 attached to its upper surface. The membrane 545 is, for example, an aluminum foil, which may be broken and punctured by the spike 429. The central channel of the spikes cooperates with the air discharge channel 424 as in the structure described above.

The first tube 544 is disposed integrally with the air discharge channel 424. The cross section of the first tube may be circular, but any shape is possible. A second tube 546, which leaves a small space 548 in the first tube 544, is disposed within the first tube 544. At the bottom of the first tube 544, a small space 548 opens into the interior of the compartment 408 within the narrow ring-shaped slit 550. The second tube 546 has a hole 552 communicating with the interior of the second tube with a small space 548 at the top end thereof. The second tube 546 is connected to the ring-shaped channel of the spike 429 as shown at its bottom.

In operation, in the case of the compartment containing the powder to be primed, water enters the second tube 546 through the spike 429 up to its uppermost level. The water is directed through the aperture 552 towards the small space 548 and downwardly towards the ring shaped slit 550 where water from the slit is guided laterally along the bottom surface of the compartment and primed, To dissolve the powder. Because the water passes slowly downward along the outer surface of the second tube 546 and the inner surface of the first tube 544, the small space still retains most of its air content.

After priming and when fluid is taken from the compartment, suction is applied by a spike inside the tube 546. The fluid is sucked toward the opening 552 upwardly in the small space 548 through the slit 550. The air in the small slit is moved below the upper side of the second tube 546, but remains trapped. The fluid fills the remainder of the second tube 546. Because the flow is slow in the second tube 546, the air stays in the upper side.

When the compartment is disengaged from the spike, the fluid in the second tube 546 is discharged to the manifold portion 404 (FIG. 5). The air cushion on the upper side of the second tube 546 prevents additional fluid from passing upward in the small space 548 and no additional fluid will escape from the compartment. Thus, apart from the first few droplets upon disengagement, droplets from the cartridge are prevented. In this structure, the diaphragm 423 used in the above structure is no longer needed.

Fig. 25 shows the same compartment as shown in Fig. 24 in which the spikes are engaged.

This structure may be used with the lactic acid compartment 408, which is initially in liquid form. The same structure may be used for other compartments surrounding the powder component, including the glucose compartment.

5, during normal operation of the concentrate mixing module 400, the heated purified water exiting the thermal control and sterilization module 300 flows through the mixed water supply connection 4a to the concentrate mixing module 400, ≪ / RTI > The bypass valve 440 of the mixing system can be output via the mixture module output connection 4b without being processed by the concentrate mixing module 400, for example, for sterilization of the downstream components It will help. The water stream entering the mixing system may be stopped by the mixed water stop valve 442. [

On the downstream side of the mixed water stop valve 442 is disposed a glucose selector valve 444 that allows the purified water to pass or stops the flow of purified water and allows the glucose solution to flow from the glucose compartment 420 downstream To be sent to the component. In order to supply water to the glucose compartment 420 to dissolve the glucose, the mixing system bypass valve 440 is opened and a reversible flow control pump 446 is used to withdraw the purified water from the mixed water supply connection 4a It is pumped through the glucose selector valve 444, the glucose input valve 490 and the fluid input channel 434 to the glucose compartment 420. The flow control pump 446 is a Gambro standard part number. It is a piston pump with a structure similar to K1 4207 002, but the diameter is 9 mm or 12 mm instead of the standard 6 mm diameter. A glucose recycle pump 448, such as a gear pump or a centrifugal pump, recirculates water through the glucose compartment 420 through the fluid input channel 434 and the glucose output channel 436 to ensure total dissolution of the glucose. During recirculation, the glucose input valve 490 is closed, so that the remainder of the mixing module 400 can operate independently while the glucose is being dissolved.

On the downstream side of the glucose selector valve 444, the flow of the purified water (or the glucose solution from the glucose compartment 420), which the mixing chamber 450 exits from the mixed water supply connection 4a, is passed through the reversible salt input positive displacement pump 452 ) (Gambro standard part K1 4207 002).

The flow control pump 446 is provided with a tachometer meter 454 and the salt input volumetric pump 452 is also provided with a tachometer meter 454. The tachometer meters 454, 456 monitor the volumetric flow rate of each pump 446, 452 to ensure correct operation. The flow control pump 446 is bypassed by opening the flow control pump bypass valve 458 if the pumping action is solely under the control of the salt input volatile pump 452. [ The salt input volumetric pump 452 and the flow control pump 446 are both piston pumps having the volumetric accuracy necessary to control the salt concentration of the PD fluid. The maximum flow rate through the salt input volumetric pump 452 is, for example, 50 ml / min., And the maximum flow rate through the flow control pump 446 is, for example, 180 ml / min.

On the downstream side of the flow control pump 446, two independent mixed conductivity meters 460 monitor the composition of the salt solution therethrough, along with each independent mixed temperature sensor 462. The two conductivity meters 460 and the two temperature sensors 462 are provided as an extra when one meter or sensor fails. One of these meters and one of the temperature sensors communicates with the control system, and the other meters and sensors communicate with the protection system (see FIG. 1A).

On the downstream side of the mixed conductivity meter 460 and the mixing temperature sensor 462, the drain disinfecting valve 464 allows the water coming from the mixed water supply connection portion 4a to pass through the mixed module drain connection portion 15. The drain disinfection valve 464 is operated in this manner during disinfection. In this case, the water entering the mixed water supply connection portion 4a is heated to the disinfection temperature by the heat control and sterilization module 300 and then sent to the drain module 500 through the drain disinfection valve 464 The drainage module 500 is sterilized.

A reservoir filling valve 466 is connected to the mixing conductivity meter 460 and the condensate conduit 460. The reservoir filling valve 466 is connected to the mixing module output connection 4b, And guides it to the storage unit 468. The condensate storage unit 468 is provided with a storage unit output valve 470. The condensed PD fluid may be sent to the salt input volumetric pump 452 through the storage unit output valve.

The concentrate reservoir 468 is also provided with a reservoir air outlet connection 472 which is connected to the reservoir air outlet valve 468 to exhaust air during the filling or emptying of the concentrate reservoir 468, And can be opened to the atmosphere from the manifold cap 406 under the control of the controller 496. Since the concentrate storage 468 contains the concentrated PD fluid to be supplied to the patient, the storage air discharge connection 472 is disinfected. To accomplish this and disinfect the spikes 429 during disinfection, the manifold cap 406 is lowered onto the manifold 404 to form a sealed cavity as shown in FIG. This cavity can be filled with a high temperature disinfecting fluid from the thermal control and sterilization module 300 through the mixed water supply connection 4a, as described below. The air initially contained in the cavity formed by the manifold 404 and the cap 406 is sent to the drain module 500 via the cap air vent valve 474 and the mixed module drain connection 15. Once all air has been vented from the cavity, the cap air vent valve 474 provides a connection from the cavity formed by the manifold 404 and the manifold cap 406 to the mixing module drain connection 15, Disinfectant fluid can be circulated through the cavity. In this way, the reservoir air discharge connection 472 can be completely sterilized, even if the reservoir air discharge valve 496 is open to the atmosphere during operation of the system. The reservoir air discharge valve 496 is closed during this process but once the manifold 404 and the manifold cap 406 have been disinfected the disinfection fluid is released from the reservoir air discharge connection 472, And then sent to the module drain connecting portion 15 to sterilize the storage air discharge valve 496. [ The cavity formed by the manifold 404 and the manifold cap 406 is disinfected by connecting the cavity to the atmosphere at the manifold cap air outlet 6 and then opening the cap air drain valve 474 . Next, the disinfectant fluid may be drained to the drain module 500 via the storage section drain disinfection valve 498, the storage section air discharge valve 496, and the mixing module drain connection section 15.

The salt from the compartment of the disposable concentrate container 402 is dissolved and mixed by opening and closing a valve on the fluid lines 426 and 430 of the compartment 408-418 so that the salt input volatile pump 452 Can supply water to each compartment 408-418 and subsequently withdraw salt solution from each compartment.

Each of the compartments 408-418 of the disposable concentrate container 402 has a respective input valve, namely, a lactate input valve 478, a cleaner input valve 480, a sodium bicarbonate input valve 482, a sodium chloride input valve 484, A calcium chloride input valve 486, and a magnesium chloride input valve 488 are provided. The function of the combined air discharge and fluid channel 428 of sodium bicarbonate compartment 412 and sodium chloride compartment 414 is also controlled by a sodium bicarbonate air discharge valve 492 and a sodium chloride air discharge valve 494, .

The correct operation of these valves 478-488 is monitored using a salt input pressure sensor 476 in the following manner. After one of the input valves 478-488 is activated and closed, a signal is sent to all input valves 478-488 to close them. Next, energy is supplied to the salt input volumetric pump 452 to pump water from the mixed water supply connection 4a toward the input valves 478 to 488. The pressure generated by the salt input volumetric pump 452 is monitored by the salt input pressure sensor 476. When one of the input valves 478 to 488 is fixed to the open position, a sufficiently high pressure can not be obtained, and such a wrong state is detected by the salt input pressure sensor 476. [

In the case of the first type of compartments 408, 410, 416 and 418, taking the calcium chloride compartment 416 as an example, the water coming out of the mixed water supply connection 4a is discharged by the salt input volumetric pump 452, And is pumped through the fluid channel 426 of the calcium chloride compartment 416 through the calcium chloride input valve 486 into the calcium chloride compartment. All other input valves 478-488 of the other compartments 408-418 are closed. The air in the calcium chloride compartment 416, which is replaced by water pumped into the calcium chloride compartment 416, is vented to the atmosphere through the air discharge channel 424.

When the salt input volumetric pump 452 passes the required amount of water into the calcium chloride compartment 416, all of the calcium chloride powder in the compartment is dissolved when the disposable concentrate vessel is loaded. The weight of the calcium chloride in the calcium chloride compartment 416 is predetermined and the volume of water dispensed by the salt input volumetric pump 452 is known and can lead to a rough concentration of the calcium chloride solution formed in the calcium chloride compartment 416. [

The positive displacement pump 452 is driven by a stepper motor. Each step corresponds to a well defined volume of pumped fluid, which depends on the rotational position of the stepper motor. The control system of the pump motor accurately calculates the volume pumped by the pump.

The flow control pump 446 is operated to draw water from the mixed water supply connection 4a at a predetermined speed in order to deliver the required amount of calcium chloride solution to the concentrate reservoir 468. [ The water is guided to the mixing module drain connecting portion 15 by the discharge sterilization valve 464. The salt input volumetric pump 452 passes the calcium chloride solution through the mixing chamber 450 at a controlled volumetric flow rate through the flow control pump 446 and through the mixing conductivity meter 460 to the mixing module drain connection 15). The flow rate passing through the mixed water supply connection portion 4a is reduced by the same amount as the flow rate generated by the salt input volumetric pump 452 because the flow rate passing through the flow control pump 446 is constant, A predetermined dilution ratio is obtained. The mixed conductivity meter 460 measures the conductivity of the diluted calcium chloride solution and measures its concentration. The flow rate of the salt input volumetric pump 452 is adjusted to obtain a predetermined concentration. Once the concentration is achieved, the drain disinfection valve 464 is switched and the reservoir fill valve 466 directs the calcium chloride solution to the concentrate reservoir 468, which reserves all of the concentrated PD fluid This is where the solution is stored until the ingredients are ready. Therefore, the total volume and concentration of the calcium chloride solution passed through the flow control pump 446 into the concentrate reservoir 468 is known, and thus the amount of calcium chloride present in the concentrate reservoir is also known. It should be noted that the order in which the salts are introduced is described in more detail below.

A process similar to the dissolution and measurement of the calcium chloride solution is used to prepare the magnesium chloride solution from the magnesium chloride compartment 418. [ The detergent also dissolves in the detergent compartment 410 in this manner when necessary. The lactic acid is optimally guided toward the concentrate reservoir 468 without being diluted. As described later, the solution made of the detergent is not a component of the PD fluid.

Since solutions of sodium bicarbonate and sodium chloride are used in greater amounts than magnesium chloride and sodium chloride, they are produced in a different manner than magnesium chloride and calcium chloride. Considering sodium bicarbonate as an example, all of the input valves 478-488 are closed except for the sodium bicarbonate input valve 482. The sodium bicarbonate air discharge valve 492 is set such that the combined air discharge of the sodium bicarbonate compartment 412 and the fluid channel 428 are connected to the atmosphere via the manifold 404. The salt input volumetric pump 452 pumps the measured amount of water from the mixed water supply connection 4a through the mixing chamber 450 through the sodium bicarbonate input valve 482 and through the combined priming and output Pumped through the channel 430 into the sodium bicarbonate compartment 412. Sufficient water is introduced into the sodium bicarbonate compartment 412 where the sodium bicarbonate powder in the compartment 412 is fully immersed in water.

Once the sodium bicarbonate powder in the sodium bicarbonate compartment 412 has been fully immersed, the sodium bicarbonate air vent valve 492 is switched to remove the combined air of the sodium bicarbonate compartment 412 from the mixed water supply connection 4a And provides a fluid path to the discharge and fluid channels 428. The salt input volumetric pump 452 withdraws substantially inverted sodium bicarbonate solution from the sodium bicarbonate compartment 412 through the combined priming and output channel 430 and sodium bicarbonate input valve 482 do. The conductivity of the sodium bicarbonate solution is controlled and the solution is diluted and stored in the concentrate reservoir 468 in the same manner as the calcium chloride solution described above.

The mixing and measurement of the sodium chloride solution is carried out in a corresponding manner.

The amount of salt in each compartment 408-418 is selected to produce a salt solution of a particular conductivity in each compartment 408-418 during correct operation. Thus, if the system is not working properly and magnesium chloride is produced instead of a bad salt solution, such as calcium chloride, this can be distinguished by the conductivity measurement.

In addition, the salt is mixed at a relatively high concentration to provide an environment in which the bacteria can not survive and to aid in bacterial control. The relatively high concentration allows the conductivity meter 460 to operate within a range that is relatively insignificant compared to the measured error, thereby increasing the accuracy of the concentration measurement.

Dissolution of the glucose solution was described above. The required amount of glucose solution is pumped by the flow control pump 446 through the glucose input valve 490, the glucose selector valve 444 and the reservoir fill valve 466 towards the concentrate reservoir 468. The pump is used because its capacity is large and glucose can be weighed within a short time.

At the end of the dissolving and measuring operation, the concentrate reservoir 468 contains a concentrated PD fluid of higher absolute concentration, but having salt and glucose of the exact relative proportions required by the individual prescription of the patient. Therefore, it is only necessary to add water to the concentrated PD fluid to obtain the PD fluid according to the prescription of the patient.

When the PD fluid is to be supplied to the patient through the mixing module output connection 4b, the concentrated PD fluid at the measured flow rate (about 50 ml / min.) Is supplied to the concentrate Is withdrawn from the reservoir 468 via the reservoir output valve 470, which pumps the concentrated PD fluid into the mixing chamber 450. The flow control pump 446 is bypassed by opening the flow control pump bypass valve 458 and the PD fluid at a constant flow rate (about 300 ml / min.) Is delivered to the volume pump 352 from the mixing module output connecting portion 4b (see Fig. 4). The flow rate from the mixing module output connection 4b is greater than the flow rate produced by the salt input volumetric pump 452 and the additional fluid flow rate not provided by the salt input volatile pump 452 / min.) is drawn out from the mixed water supply connection portion 4a. In this way, the concentrated PD fluid exiting the concentrate reservoir 468 is diluted in the mixing chamber 450 by the water exiting the mixed water supply connection 4a, so that the desired concentration of PD fluid is delivered to the mixing module output connection < RTI ID = (4b). The concentration of the PD fluid is monitored by the mixed conductivity meter 460 and controlled by varying the flow rate through the salt input volumetric pump 452.

In this way, dilution of the concentrated PD fluid exiting the concentrate reservoir 468 not only reduces the salt and glucose concentration of the PD fluid to the required level, but also reduces the level of the dissolved gas in the PD fluid to a medically To less than the maximum level required. The present inventors believe that at the time of preparation for use of the concentrated PD fluid in the concentrate reservoir 468, the PD fluid will at most saturate with the dissolved gas entering the system during the dissolution of the salt and glucose Respectively. However, water entering the concentrate mixing module 400 from the mixed water supply connection portion 4a is degassed by the water preparation module 200. [ The dilution ratio of the flow of concentrated dialyzed fluid pumped by the salt input positive displacement pump 452 and the flow of water into the mixed water supply connection 4a is at least such that the gas is saturated and the concentrated dialysate is maintained at a medically required level Lt; RTI ID = 0.0 > g / mol < / RTI >

The flow through the reverse osmosis membrane disinfection connection 3 is controlled by a reverse osmosis membrane disinfection valve 499. During disinfection, water at the disinfection temperature is supplied to the mixed water supply connection 4a by the heat control and sterilization module 300, and the mixed water stop valve 442, the glucose selector valve 442, Through the reverse osmosis membrane disinfection connection 3 through the mixing chamber 450, the mixing chamber 450, the reverse osmosis membrane disinfection valve 499, the mixing chamber 450, and the reverse osmosis membrane disinfection valve 499.

After placing the disposable concentrate container 402 in place and engaging the spikes 429 of the manifold 404, the following sequence of operations occurs.

First, water is primed in the detergent compartment 410 by introducing 80 ml of water into a detergent compartment 410 containing 20 g of sodium carbonate to produce a sodium carbonate solution having a concentration of about 2284 mmol / l. This sodium carbonate solution is used for cleaning purposes as described above.

The peritoneal dialysis fluid consists of six distinct substances: magnesium chloride, calcium chloride, sodium bicarbonate, sodium chloride, lactic acid, and glucose. The amount of material in each compartment 410 - 420 is given in Table 2.

To prime the disposable concentrate container 402, 962 ml of water is first introduced into the glucose compartment 420 by a flow control pump 446. Since the flow control pump 446 can operate at a flow rate of about 180 ml / min., This introduction will take about 5.5 minutes. Next, the glucose input valve 490 is closed, and the glucose recycle pump 488 operates to recycle the glucose in the glucose compartment 420 to facilitate complete dissolution.

Thereafter, the magnesium chloride input valve 488 is opened and 48.4 ml of water is introduced into the magnesium chloride compartment 418. Next, the magnesium chloride input valve 488 is closed, the calcium chloride input valve 486 is opened, and 145.2 ml of water is introduced into the calcium chloride compartment 416. The introduction of such water is performed by a salt input volumetric pump 452 having a maximum capacity of about 50 ml / min. The two priming steps take about 4 minutes together. Magnesium chloride and calcium chloride are completely dissolved in the introduced water during or after introduction of water into the compartment, and completely dissolve all the salt particles.

The water is then introduced into the sodium bicarbonate compartment 412 by opening the sodium bicarbonate input valve 482 and introducing about 60 ml of water by the salt input volumetric pump 452. The exact amount of water introduced into the sodium bicarbonate compartment 412 is such that the water level does not rise above the combined air vent and fluid channel 428 so that water flows down the channel 428 through the sodium bicarbonate air discharge valve 492 It is not important unless it is sent to the manifold 404. Nevertheless, it does not matter if some of the water passes in this way.

The same procedure is performed on the sodium chloride compartment 414 by introducing about 100 ml of water into the compartment by the salt input volumetric pump 452. All the powders in the sodium bicarbonate compartment 412 and the sodium chloride compartment 414 are not completely soluble because the amount of water is not sufficient to dissolve all of these powders.

No water is added to the lactic acid compartment 408 containing 120 g of lactic acid at a concentration of 30%.

By the priming procedure described above, the different compartments (408-420) include salts and glucose electrolyte solutions at the following concentrations when taken from each compartment at 25 < 0 > C.

Magnesium chloride: 2455.8 mmol / l

Calcium chloride: 2117.3 mmol / l

Sodium bicarbonate: 1199 mmol / l

Sodium chloride: 5253 mmol / l

Lactic acid: 3500 mmol / l

Glucose: 3393.6 mmol / l

The exact order of priming each compartment may be different from the order described above.

The next step in the process is to transfer the measured amount of electrolyte and glucose to the concentrate reservoir 468. The solution in the resulting concentrate reservoir 468 may be a solution having a concentration of five times the concentration of the final required solution. Next, the concentrate storage solution is diluted at a ratio of 1: 5 before it is sent to the OLA 375 for sterilization before it is introduced into the patient ' s multiple membrane cavity. Thus, the concentrate reservoir 468 should contain 600 ml of concentrated solution to provide 3000 ml of final peritoneal dialysis solution after dilution.

The first material introduced into the concentrate reservoir 468 is sodium bicarbonate. The sodium bicarbonate air discharge valve 492 is adjusted to connect the combined air discharge and fluid channel 428 to the mixed water supply connection 4a and the sodium bicarbonate input valve 482 is opened to allow the combined injection and / And connects the output channel 430 with the salt input positive displacement pump 452. By operating the salt input volumetric pump 452, a substantially saturated sodium bicarbonate solution is taken from the bottom of the sodium bicarbonate compartment 412 and the water exiting the water preparation module 200 is directed to the combined air vent and fluid channel (428) to the top of the sodium bicarbonate compartment (412). To provide the final solution with a concentration of bicarbonate of 40 mmol / l, 120 mmol / l sodium bicarbonate needs to be transferred to the concentrate reservoir 468, which is pumped by the salt input volumetric pump 452 ≪ / RTI > Thus, the salt input volumetric pump 452 may operate at a pump rate of 40 ml / min for 2.5 minutes to provide the required amount. At the same time, the flow control pump 446 is adjusted to 60 ml / min. To obtain a dilution ratio of 1: 1.5 which produces a conductivity of about 35 mS / cm.

As described above, the mixed solution is sent to the drain module 500 through the drain disinfecting valve 464 and the mixed module drain connecting section 464 until a stable value is obtained from the mixed conductivity meter 460. Next, the drain disinfection valve 464 and the storage part charging valve 466 are switched to transfer the solution to the concentrate storage part 466. [

The conductivity measurement in the mixed conductivity meter 460 is converted by the control system to the corresponding concentration of sodium bicarbonate and multiplied by the flow rate as measured by the tachometer meter 454 of the flow control pump 446 To obtain the amount of sodium bicarbonate passing through the mixed conductivity meter 460 per minute. By integrating this amount of minutes per time with respect to time, the total amount of material fed to the concentrate storage 460 is obtained. 120 mmol is transferred, the reservoir charge valve 464 stops further introduction into the concentrate reservoir 468 and guides the solution to the drain module 500 via the mix module drain connection 15 . The fact that the correct amount of material has been dispensed to the concentrate reservoir 468 may be controlled by the taco meter 456 of the salt input volumetric pump 452, which must pump 100 ml.

Immediately after the switching of the reservoir fill valve 464, the salt input volumetric pump 452 is inverted to pump clean water in the opposite direction and is placed in the tube between the sodium bicarbonate input valve 482 and the mixing chamber 450 By pushing out the sodium bicarbonate, the material is saved and the tube system is flushed with clean water. The volume of substantially saturated sodium bicarbonate thus recovered is relatively small, but may still be significant. Because there is usually an air cushion at the top of the compartment 412, a corresponding volume of air is transferred into the combined air discharge and fluid channel 428. During the next operation of the compartment, the volume of air is reintroduced into the compartment 412.

The flow control pump 446 operates to flush the rest of the pipe system downstream of any sodium bicarbonate mixing chamber 450.

If the peritoneal dialysis fluid contains only substantially bicarbonate as a buffer, the final concentration of buffer may be adjusted by adjusting the amount of bicarbonate introduced into the concentrate reservoir 468. When 100 ml is introduced, the final bicarbonate concentration is 40 mmol / l, and when 87.5 ml is introduced, the final bicarbonate concentration is 35 mmol / l. The pH may be adjusted by adding lactic acid.

If the final peritoneal dialysis fluid comprises a mixture of sodium bicarbonate and sodium lactate, such as 25 mmol / l bicarbonate and 15 mmol / l sodium lactate, the following procedure is followed. A mixture of about 5: 35 to 35: 5 can be obtained, or a mixture having a total sum of more than 40 can be obtained.

The lactic acid input valve 478 is opened to connect the lactic acid compartment 408 to the salt input volumetric pump 452. The mixed water stop valve 442 is closed to prevent dilution of the lactic acid and the flow control pump bypass valve 458 is opened to bypass the flow control pump 446. If 15 mmol / l of sodium lactate is desired, the salt input volumetric pump 452 pumps 16 ml of lactic acid (30% concentration) into the concentrate reservoir 468. The concentration of the lactic acid solution may be monitored by a mixed conductivity meter 460, which should exhibit a conductivity value of about 39 mS / cm.

During the introduction of the lactic acid into the bicarbonate solution in the concentrate reservoir 468, the lactic acid reacts with the bicarbonate ions to form carbon dioxide, which includes the reservoir air outlet connection 472, the reservoir air outlet valve 496, And is discharged to the atmosphere through the discharge valve 474. A carbon dioxide cushion is formed at the top of the concentrate storage 468, which is not transferred to the ambient atmosphere. Therefore, the partial pressure of carbon dioxide becomes 1 atm (1 Bar), and in the equilibrium state, carbon dioxide having a concentration of about 23 mmol / l is dissolved in the liquid in the concentrate storage portion. The formation of carbon dioxide is relatively fast, but a short pause period may be required until carbon dioxide production is stopped.

Again, once the salt input positive displacement pump 452 is reversed to push the lactate into the lactic acid compartment 408 until the water reaches the lactate input valve 478 or just before it reaches it, And is flushed with water through a pump 446.

Next, sodium chloride is introduced into the concentrate reservoir 468. To provide 140 mmol / l to the final solution, 470 mmol should be transferred to the concentrate reservoir 468, which corresponds to 80 ml of concentrated solution. Since sodium chloride has a very high conductivity, sodium chloride is diluted as much as possible in the mixing chamber 450. However, this dilution is not so large because there is a limit on the final volume in the concentrate reservoir 468. As an example, a dilution ratio of 1: 4 is given below. Thus, the flow control pump 446 is adjusted to 40 ml / min., And the salt input volumetric pump 452 is adjusted to 160 ml / min to produce a conductivity of about 98 mS / cm. The same integration method as described above for sodium bicarbonate is used to determine when a sufficient amount of sodium chloride has been introduced into the concentrate reservoir 468. Alternatively, the time when the salt input positive displacement pump 452 pumps 80 ml is determined, which should be about 2 minutes later.

Again, the salt input volumetric pump 452 is reversed to push the sodium chloride solution into the sodium chloride compartment 414 and push some of the air into the combined air exhaust and fluid channel 428.

Next, the glucose input valve 490 is opened to transfer glucose to the concentrate storage 468. Once a final glucose concentration of 1.5% is obtained, a 75 ml glucose solution should be transferred, and if 2.5% is obtained, 125 ml should be transferred, and if 4.0% is achieved, 200 ml should be transferred. To save time, the flow control pump 446 is used for this purpose. Glucose has no inherent conductivity, which is checked by the mixed conductivity meter 460. The glucose selector valve 444 is activated to transfer water from the mixed water supply connection 4a through the flow control pump 446 to the tube system Flush. As described above, the flow control pump 446 may be reversed first, if desired, while the mixing system bypass valve 440 is open to push glucose into the glucose compartment 420. Since the recovered volume is small compared to the volume in the glucose compartment, such recovery may not be used for glucose.

The dilution ratio of sodium chloride is selected according to the desired glucose concentration, and the volume obtained in the concentrate reservoir 468 is now about 570 ml.

Finally, magnesium and calcium are introduced into the concentrate reservoir 468. These materials are introduced as late as possible when the bicarbonate is diluted to low concentrations to avoid problems associated with settling.

The primary magnesium chloride is introduced by opening the magnesium chloride input valve 448 and operating the salt input volumetric pump 452. To obtain a final concentration of 0.5 mmol / l, only 1.5 mmol of magnesium chloride corresponding to 0.6 ml should be transferred by the salt input volumetric pump 452. The salt input volumetric pump 452 can meter these small quantities with sufficient accuracy. The pump has a volume of 228 microliters per revolution and is controlled to be 1/100 revolution or more.

Magnesium chloride is not introduced into the concentrate reservoir 468 in a concentrated form to prevent local precipitation. Thus, the flow control pump 446 is operated at a rate of ten times the speed of the salt input volumetric pump 452 to obtain a dilution ratio of 1:10. Next, the conductivity of the magnesium chloride solution is about 35 mS / cm. By integrating the concentration obtained from the mixed conductivity meter 460 and multiplied by the flow rate obtained from the flow control pump 446, the delivered amount is obtained. The dispensed volume is checked by a salt input volumetric pump 462, which must pump 0.6 ml. After completing the introduction into the concentrate reservoir 468, the salt input volumetric pump 452 is reversed to push the magnesium chloride into the magnesium chloride compartment 418. This process is important for magnesium chloride and calcium chloride, which are provided in small quantities.

Finally, the same procedure is carried out for calcium chloride. To provide 1.5 mmol / l calcium in the final solution, it is necessary to transfer 4.5 mmol corresponding to 2.1 ml concentrated solution to the concentrate reservoir 468. As with magnesium, this process is performed by diluting at a ratio of 1:10. Next, the conductivity is about 34 mS / cm.

When calcium ions are mixed with bicarbonate ions, there is always a risk of calcium carbonate depositing. An air cushion containing carbon dioxide is maintained on the concentrate reservoir 468 to provide a saturated carbon dioxide gas content to the solution to ensure that the pH of the solution is as low as possible so that no deposition occurs.

In order to maximize the content of carbon dioxide prior to mixing with calcium chloride, lactic acid may be introduced into the mixing process as late as possible, that is, just before the addition of magnesium chloride and calcium chloride, to produce carbon dioxide and saturate the complete solution with carbon dioxide have. The order of sodium bicarbonate, sodium chloride, and glucose may also be different from those described above. For example, sodium chloride may be used first, followed by glucose and sodium bicarbonate.

After forming a concentrated PD solution in the concentrate reservoir 468, the solution is diluted at a ratio of 1: 5. In this mode of operation, the OLA pump 352 is operated at 300 ml / min. And the salt input volumetric pump 452 is operated at 60 ml / min. To obtain a dilution ratio of 1: 5. The mixed conductivity meter 460 controls the concentration of the mixed solution and adjusts the salt input volumetric pump 452 to prevent a change in the conductivity.

A slightly deformed mixing portion is shown in Figure 5a. A metering pump 448a is inserted into the pipe between the glucose input valve 490 and the glucose selector valve 444. The metering pump 446a is classified by a valve 490a. The glucose selector valve 444 is replaced by a direct connection to the mixing chamber 450. These additional components allow measurement of the glucose concentration in the glucose compartment 420. The operation is as follows.

After the glucose is dissolved in the water introduced into the glucose compartment 420, the concentration of glucose should be 50%. However, there is always a risk of error and it is desirable to be able to control the glucose concentration.

The sodium chloride input valve 484 and the sodium chloride air discharge valve 494 are opened and the salt input volumetric pump 452 is activated and the flow control pump 446 is activated to initiate the Glucose check process, To provide a sodium chloride solution having a concentration of 500 mmol / l, i.e. a dissolution rate of about 1:10. The mixed conductivity meter 460 should measure about 46.7 mS / cm. The flow control pump 446 is operated at about 50 ml / min, and the salt input volumetric pump 452 is operated at about 5 ml / min. The glucose input valve 490 is then opened and the metering pump 448a is operated to transfer the glucose solution from the glucose compartment 420 to the fluid input channel 434, the glucose input valve 490, and the metering pump 448a. Lt; RTI ID = 0.0 > 450 < / RTI > The metering pump 448a is driven, for example, at 20 ml / min.

The introduction of glucose into the sodium chloride solution in the mixing chamber 450 decreases the conductivity as measured by the mixed conductivity meter 460. This reduction is in essence proportional to the concentration of the glucose solution. Thus, the glucose concentration in the glucose compartment 420 can be monitored.

After measuring the glucose concentration, the process described above may occur.

Alternatively, a mixture obtained as described above in connection with FIG. 5A, i. E., A mixture of glucose and sodium chloride, may be transferred to the concentrate reservoir 468. In such a case, the sodium salt input positive displacement pump 452 should have a higher rate to ensure that the amount of water introduced into the concentrate reservoir 468 is not too much.

Instead of using a separate metering pump 448a, the same operation can be achieved using a glucose recycling pump 448, such as a reversible metering pump.

To monitor the decrease in conductivity, lactic acid may be used and the lactic acid may be diluted with glucose. In this case, no additional pump is needed as compared to Fig. The operation is such that 5 ml / min of water is passed from the mixed water supply connection 4a into the mixing chamber 450 while the glucose selector valve 444 and the mixed water stop valve 442 are opened, The valve 478 may be opened and the salt input volumetric pump 452 may be operated at 10 ml / min and the flow control pump 446 may be adjusted at 15 ml / min. Next, the glucose input valve 490 is opened and the glucose selector valve 444 is switched to replace the water feed (5 ml / min.) Into the mixing chamber 450 with glucose. The decrease in conductivity is monitored and a calculation is made to determine the corresponding glucose concentration.

In Figure 5a, an electric heater 438a is disposed in the fluid input channel 434 leading to the glucose compartment 420 to heat the glucose solution recirculated during the dissolution process to promote dissolution. Since glucose becomes lower in temperature during dissolution, heating is necessary to maintain the temperature at, for example, 40 DEG C during the complete dissolution step.

Another alternative configuration of the glucose metering step is shown in Figures 5b and 4a. Referring first to Figure 5b, the metering pump 448a has been replaced by a reversible metering pump 448b. The metering pump 448b is configured to pump the glucose solution for a back pressure of several bar, greater than or equal to 3 bar, preferably greater than or equal to 6 bar, or for reasons described below. Valve 490a bypasses pump 448b. A glucose input valve 490b is disposed between the mixing chamber 450 and the inlet tube 430 to prime the glucose in the compartment 430.

The operation of the alternative configuration according to Figure 5b is the same as described above with respect to Figure 5 or Figure 5a except that glucose does not enter the concentrate reservoir 468. [ Instead, the enriched glucose is metered by a metering pump 448b and transferred to the outlet connection 4c via the actuated valve 490b to the inlet connection at the center of the OLA sterilizer, as shown in Figure 4a It is.

In the alternative OLA sanitizer structure shown in Fig. 4A, the oil bath arrangements 364 to 368 have been replaced by electric heaters 364a. The inlet fluid entering the OLA configuration through inlet 4b, valve 356 and heat exchangers 360, 362 is an electrolyte fluid having components that are not heat sensitive. Thus, the electrolyte fluid may be heated by an electric heater without the risk of formation or decomposition of harmful substances, although the electric heater may have hot spots. The heat sensitive portion of the final solution, i.e., glucose, enters behind the electric heater 364a at the inlet 4c. In this position, the electrolyte fluid is, for example, a high temperature of 150 DEG C and an absolute pressure of 6 bar. The inflow fluid rapidly heats the concentrated glucose solution to a high temperature, for example, 148 占 폚. The combined fluid is maintained in the coil 363 at a high temperature for a predetermined time that is determined by the flow distance. Next, the combined fluid is rapidly cooled in heat exchangers 362, 360. The temperature is monitored by a temperature sensor 370. By this action, the heat-sensitive glucose moiety is heated to a substantially square temperature curve, which is advantageous to prevent the formation of sterilization and glucose degradation products. Sterilization of the glucose moiety may be very well controlled so as not to over-sterilize the glucose. The fact that the electrolyte fluid is slightly sterilized does not imply any disadvantage.

In order to prevent the problem of deposition of calcium carbonate in the mixed configuration of FIG. 5B, scaling problems of the tube portion, calcium ions and magnesium ions may be included in the glucose fluid that is introduced later in the OLA configuration of FIG. 4A. In this embodiment, calcium chloride and magnesium chloride are transferred to the glucose compartment 420 after the glucose is dissolved, but before the glaucose is metered to the output connection 9b. The valve 486 is opened and the pump 452 is operated to withdraw the calcium chloride from the compartment 424. Valves 442 and 458 are closed, and pump 446 is inactive. The valve 490b is disposed at the position shown in Fig. 5B, and the valve 490a is opened. The calcium chloride fluid metered by the pump 452 must be sent to the glucose compartment 420 via the mixing chamber 450 and valves 490b and 490a. The amount of calcium chloride transferred to the glucose compartment 420 is carefully monitored by the metering pump 452. The same operation occurs for magnesium chloride.

Finally, the combined glucose, calcium chloride and magnesium chloride are metered into the output 4C as contained in the final PD fluid. With this arrangement, sodium bicarbonate and calcium chloride are not mixed until they are in the diluted PD fluid, which means that the risk of deposition is minimized.

Alternatively, the calcium chloride may be metered into the mixing chamber 450 by a metering pump 452. The flow control pump 446 is operated to dilute the calcium chloride, and the fluid is measured in the conductivity meter 460. Next, the measured and diluted calcium chloride is delivered to glucose via valve 464a, shown in dashed lines in FIG. 5b. The same operation occurs for magnesium chloride.

Alternatively, or in combination, (and portions of) calcium chloride and / or magnesium chloride may be transferred to the concentrate reservoir 468 as described above.

The drainage module 500,

The drainage module 500 is shown in detail in FIG. The fluid supplied to the drain module 500 by the peripheral pressure drain connecting portion 14b and the mixed module drain connecting portion 15 is guided optimally directly to the heat return drain connecting portion 13b, And the sterilization module 300, and the heat is recovered before returning to the heat recovery drain return connection portion 13c. The fluid entering the heat recovery drainage return connection portion 13c is sent to the external waste matter connection portion 16 through the heat recovery return valve 532. [ The temperature of the fluid exiting the heat recovery / dripping connection portion 13b is monitored by the waste disinfection temperature sensor 530.

The water coming from the heat exhaust connection part 13a originating from the cleaning waste connection part 2d of the water preparation module 200 is sent to the external drain connection part 16 through the heat exhaust connection valve 520. [

The fluid coming from the negative pressure discharge connection part 14a passes through the pressure regulation chamber 510 under a negative pressure generated by the displacement pump 508 and then passes through the drain disinfection temperature sensor 530 to the heat recovery discharge connection part 13b . The pressure regulating chamber 510 is in the form of a chamber which is closed by a movable spring biased diaphragm so that the pressure fluctuations due to the drain pump 508 are not directed to the patient along the negative pressure drain connection 14a, To be more easily controlled. The drain pump may be a peristaltic pump or a gear pump, or a pump generating a predetermined maximum pressure such as a centrifugal pump.

The pressure regulating chamber 510 also prevents the patient from being exposed to a large negative pressure. For this purpose, the pressure regulating chamber 510 may be provided with a limit switch 512, 514 for monitoring the position of the spring-biased piston 516 in the chamber 510. The switch controls the drain pump 508 to provide a negative pressure that is compatible with a safe patient condition during the patient ' s drainage process, such as not exceeding one meter of water pillar negative pressure with respect to the atmosphere. May be used to provide < / RTI >

The disinfectant fluid at a high temperature enters the drainage module 500 through the mixed module drainage connection portion 15, the negative pressure discharge connection portion 14a, and the peripheral pressure discharge connection portion 14b. The disinfectant fluid is sent from the drain module 500 to the heat control and sterilization module 300 via the drain disinfection temperature sensor 530 along the heat recovery connection section 13b. The heat from the disinfectant fluid is recovered in the heat control and sterilization module 300 and the fluid has a heat recovery discharge return connection 13c for sending the fluid through the heat recovery return valve 532 to the external waste connection 16 And then returns to the drainage module 500. The chemical disinfectant (or hot water in the case of thermal disinfection) coming from the water preparation module 200 enters the drain module 500 through the heat exhaust connection 13a and is sent directly to the external exhaust connection 16.

The cycler and sterilizable connector module (600)

The cycler and sterilizable connector module 600 are shown in detail in FIG. In normal operation, the aseptic PD fluid is provided to the cycler and sterilizable connector module 600 through the aseptic fluid connection 8a to pass through the patient inlet valve 602 to the sterilizable dialysate line connector 604 ). The sterilizable connector 604 may be of the type disclosed in International Publication No. WO96 / 05883 (Gambro AB), which is incorporated herein by reference.

The operation of the sterilizable connector 604 is schematically illustrated in Figures 19a-19d. 19A, the sterilizable connector 604 is disposed within two corresponding chambers 632 to accommodate a double male connector 630 at the end of the disposable fluid line 10 . The end of each prong of the male connector 630 is closed by a perforable membrane 634. The membrane 634 is perforated by a respective membrane spike 636 when the male connector 630 is fully inserted into the chamber, as shown in Figure 19c. The membrane spike 636 has a channel through which the fluid can flow through in the direction of the arrows in Figures 19b and 19c. The chamber 632 is connected by a fluid passage 638 which can be opened and closed by a connector valve 640. In an alternate embodiment, there is no connector valve 640 as shown in Figure 19B.

Initially, the male connector 630 is partially inserted into the chamber 632, as shown in Fig. 19B. The connector valve 640 is opened and water of sterilization temperature and sterilization pressure 3 bar is circulated through the membrane spike 636, the chamber 632, the fluid passage 638 in the direction of the arrow in Fig. By circulating sterilizing water, chamber 632, membrane 634 and membrane spike 636 are sterilized. Once this sterilization operation is complete, the male threaded connector 630 is fully inserted into the chamber 632, the membrane 634 is pierced and the fluid path through the membrane spike to the disposable dialysate line 10 is opened . At the same time, the fluid connection between the chamber 632 and the fluid passageway 638, the area around the spike, is closed by the male threaded connector 630. Next, the fluid, for example, the PD fluid, may flow in the direction of the arrow, as shown in FIG. 19C, during rinsing, infusing and draining the patient's multiple membrane steel.

At the end of the treatment period, the flow of PD fluid flowing into the sterilizable connector 604 is stopped, the connector valve 640 is closed, the male threaded connector 630 is partially withdrawn from the chamber 632, Air can enter the disposable fluid line 10 through a recess 642 formed in the wall of the inlet chamber 632. [ The remaining fluid in the disposable fluid line 10 is then pumped to drain the disposable dialysate line 10, as indicated by the arrows in Figure 19d.

Referring again to FIG. 7, the PD fluid is directed from the sterilizable connector 604 through the disposable fluid line 10 from the patient injection connection 9a to the patient's multiple membrane. Patient pinch valves 624 that are opened and closed together are provided in a patient inlet connection 9a and a patient drain connection 9b so as to provide a connection between two normally closed jaws (not shown) By tightening the disposable fluid line 10, the dialyzer can physically stop the flow of the PD fluid in an emergency. The pinch valve 624 is only opened by the control system and the protection system if it is certain that it is safe for the device to operate correctly and deliver the PD fluid to the patient.

The pinch valve is also opened during insertion of the disposable line set before use.

20 shows a disposable fluid line 10 for connection to a sterilizable connector 604. Fig. From the male threaded connector 630, two separate tubes 644 extend to the Y-connector 646. The Y-connector 646 connects the two fragments 644 to the standard catheter connector 654 through the manual pinch valve 648. The catheter connector 654 is the only patient connection in the entire device 100 that has not been sterilized. In contrast, conventional PD treatment systems include a variety of aseptic connections that may introduce potentially harmful bacteria into the peritoneal cavity to cause peritonitis. Since the device contains only one aseptic connection, the risk of peritonitis is significantly reduced. The only aseptic connection is to cut the aseptic connection, e.g. the connection to the aseptic welding device, a part of the end of the line set 10 and a part of the patient's tube provided with the high temperature wafer, It can also be replaced by a connection made by obtaining. The patient tube is partially consumed and needs to be replaced at intervals. These techniques are well known and utilized. Another connection technique that is required to be sterile is the ultraviolet sterilized connector during the connection cycle.

The distance between the Y-connector 646 and the connector 645 is kept as small as possible such that the dead product in the disposable fluid line 10 is as small as less than 2 ml. The pressure drop across the disposable fluid line 10 in one direction is as small as, for example, less than 40 mbar (4 kPa) at a flow rate of 300 ml / min.

Figure 21 shows another type of disposable dialysis line 10a, which is used when focusing a patient's dialysis sample. The disposable dialysate line 10a for sampling includes a syringe 652 that is fitted to a drive mechanism (not shown) in the sampling module 700, in addition to the features of a typical disposable dialysate line 10. The syringe 652 extracts 15 ml of the drained dialysate. Since the dialysate is mixed in the body, the sampling can take place at any time during the dispensing cycle and represents the average of the total duration. The filled syringe 652 then falls off the disposable dialysate line 10a for sampling by a self-sealing frangible connection (not shown) and is sent for analysis. If desired, the syringe can be visually inspected to check the transparency of the dialysate.

Referring again to FIG. 7, in the case of attempting to empty the patient's abdominal cavity, the drained fluid is passed through the disposable fluid line 10 to the patient draining connection 9b, via the sterilizable connector 604, Out valve 606 for patient drainage. The drained fluid passes from the patient draining isolation valve 606 through the first patient draining valve 608 and passes through two independent patient draining pressure sensors 610, And monitors whether the negative pressure applied to the patient's abdominal cavity by the connection portion 14a is not bad enough for the patient. On the downstream side of the patient drainage pressure sensor 610, an output volumetric flow meter 650 measures the volume of fluid removed from the patient's multiple membrane steel, and a second patient drain valve 652 is connected to the volumetric flow meter 650 To shut off the drain connection portion 14a of negative pressure.

When the patient bypass valve 616 is open, the sterilizing bypass valve 614 opens the fluid path from the sterilizing fluid connection 8a to the drain connection 14a of the negative pressure without opening the patient It can be done. The PD fluid can be directed directly to the peripheral pressure drain connection 14b without passing through the patient by opening the sterile heat recovery bypass valve 618 on the downstream side of the patient bypass valve 616. [

During the infusion into the patient, the pressure of the PD fluid entering the multiple-membrane steel closes the patient bypass valve 616, the sterilization bypass valve 614, the second patient drain valve 612, (608) and the patient drain valve (606). In this way, pressure in the patient ' s multiple membrane is released from the Y-connector 646 of the disposable fluid line 10 to the patient pinch valve 624, the patient drain off valve 606, the first patient drain valve 608 To the patient drainage pressure sensor 610. Since the second patient drainage valve 612 is closed, there is no flow along the fluid path. With this configuration, the patient drainage pressure sensor 610 can accurately measure the pressure of the fluid entering the patient's multiple membrane during injection into the patient, since this pressure measurement is as close as possible to the double skin to be.

The pressure sensor 610 controls the drain pump 508 to start operation (and opens the valve 612) when the positive pressure becomes too large, such as a two-meter water column above the atmospheric pressure, Some are classified as waste.

A pressure regulating chamber 660 similar to the pressure regulating chamber 510 may be provided behind the patient filling valve 602 as indicated by the dashed line in FIG. The operation of the chamber 660 is the same as that described for the chamber 510.

Alternatively, with the sterilization heat recovery bypass valve 618 closed, the patient drain off valve 606 may be closed and the patient bypass valve 616 and sterilization bypass valve 614 may be opened have. In this way, a pressure tap from the aseptic fluid connection 8a to the patient drainage pressure sensor 610 is formed so that the patient drainage pressure sensor 610 is connected to the aseptic fluid connection 8a The pressure of fluid entering the patient's peritoneal cavity can then be measured.

By monitoring the pressure in the abdominal cavity, the control system is able to detect whether the patient has closed, i.e. disconnected, the disposable dialysis line 10.

During the sterilization process of the sterilizable connector 604 a hot pasteurising fluid enters the cycler and sterilizable connector module 600 through the sterilization fluid connection 8a under pressure and the patient fluid valve 602, The connector 604, the patient drain valve 606, and the sterilization bypass valve 614 to the sterilization output connection portion 8b. The first patient drain valve 608 is closed during sterilization to prevent the sterilization fluid from reaching the output volumetric flow meter 650 that may be damaged at the sterilization temperature and the pressure sensor 610 for patient drain is at the sterilization temperature ≪ RTI ID = 0.0 > of water < / RTI > Flow meters and pressure sensors that have the necessary accuracy for this role and can sustain sterilization pressure and sterilization temperatures are expensive. Thus, the first patient drain valve 608 is provided to reduce the cost of the device 100. [

Heat from the sterilization fluid is recovered in the thermal control and sterilization module 300 and the cooled fluid is returned to the cyclic and sterilizable connector module 600 via the sterile fluid return connection 8c. The fluid is sent to the ambient pressure drain connection 14b via a sterilization pressure release valve 620 and a sterilization return shutoff valve 622 that returns the fluid to ambient pressure.

In the second sterilization route, the patient inlet valve 602 is closed and the patient bypass valve 616 is opened such that the high temperature and high pressure sterilization fluid flows from the sterilization fluid connection 8a to the patient bypass valve 616 To the sterilization output connection portion 8b.

For disinfection, the fluid at the disinfection temperature passes through the fluid lines of the cycler and sterilizable connector module 600 and exits through the negative drain connection 14a and the ambient pressure drain connection 14b, Disinfect the elements.

The operation of the device

The operation of the device 100 will be described generally. The basic state of all valves is closed for most valves. Therefore, in the initial operating mode, the inlet valve 202 of the water preparation module 200 and the heat discharge connection valve 520 and the heat recovery return valve 532 of the drain module 500 are connected to the cyclic and sterilizable connector As with the patient pinch valve 624 of the module 600. Thus, in this state, the device is enclosed from the external environment.

Initially, the disposable concentrate container 402 is not connected to the manifold 404, but the disposable fluid line 10 (the membrane 634 is in a non-contact state) is partially inserted into the sterilizable connector 604 have. All of the pumps and heaters of the apparatus are initially in a non-operating state and the patient output heat exchanger 314 is initially drained of water.

Disinfection of the device

The first working step is to disinfect the entire fluid circuit, starting from the water preparation module 200. For disinfection, the inlet valve 202 is opened such that water can flow into the isolator 208. The isolator air discharge valve 209 is opened to allow air to escape from the isolator 208 to the atmosphere through the isolator air discharge 17. The disinfectant selector valve 256 is disposed to guide the waste stream from the second ROE 252 through the disinfectant cartridge 210 and the disinfection valve 212 which is open. The degassing pump 222 is in operation and withdraws from the isolator 208 via the disinfection cartridge 210 or when sufficient fluid can not be obtained from the fluid path through the disinfection cartridge 210. Fluid from the disinfection cartridge 210 (or isolator 208) is sent to the thermal control and sterilization module 300 via the cooling water output 2a and is sent to the water preparation module 200 via the cooling water return connection 2b. Gt; 322 < / RTI > Next, the fluid passes through degassing components (214-224) for degassing the fluid.

The reverse osmosis pump 236 is operable to draw fluid from the degassing chamber 224 and to pass the fluid through the first reverse osmosis membrane unit 238. The first reverse osmosis membrane bypass valve 250 is opened so that the waste fluid from the first reverse osmosis membrane unit 238 is guided to the output side of the reverse osmosis membrane so as to continue the fluid path. No fluid from the first RO exchanger 238 passes through the cleaning waste connection 2d because the flow path through the connection is clogged by the heat exhaust connection valve 520 of the drain module 500. The disinfection fluid from the output side of the first RO membrane 238 passes through the reverse osmosis pressure relief valve 260 and passes through the second RO membrane 252 and is recycled back to the disinfectant selector valve 256. Thus, it will be appreciated that water is circulated through the disinfection cartridge 210 to dilute the disinfectant and provide a first disinfection loop through which the diluted disinfectant is circulated through most of the water preparation module 200. None of the thermal control and sterilization module 300, the concentrate mixing module 400 or the drain module 500 is in an operating state during the initial operation of the water preparation module 200. Thus, there is no component for pumping fluid from the purified water connection 2c, and a negligible amount of fluid traverses the second reverse osmosis membrane unit 252, because there is no pressure differential across the membrane unit 252 . The fluid passing through the second RO exchanger unit 252 passes through the purified water connection portion 2c, the mixed water supply connection portion 4a, the mixed system bypass valve 440, the mixed module output connection portion 4b, the OLA input valve 356, The sterilized fluid connection portion 8a, the patient bypass valve 616, the sterilization heat recovery bypass valve 618, the peripheral pressure drain connection portion 14b, the heat recovery drain connection portion 13b, the heat recovery drain return connection portion 13c, And is optimally guided to the external drain connection via the heat recovery return valve 532 in an open state. The water is replaced by water exiting the tap water inlet 1 through the particle filter 204 and the water softener 206.

During the first sterilization step of the water preparation module 200, the air bleed valve 320 of the thermal control and sterilization module 300 is opened and the patient output heat exchanger pump 316 fills the patient output heat exchanger with the disinfectant, Is operated to recycle the disinfectant through the recirculation throttle valve (310).

The flow through the cooling water return connection portion 2b is stopped by completely closing the proportional valve 214 in a state where the degassing bypass valve 226 is also closed. The patient output heat exchanger pump 316 is then used to pump the disinfectant from the cooling water output 2a into the isolator 208 through the open bleed valve 320 and the patient output heat exchanger exhaust connection 2e And disinfects the patient output heat exchanger exhaust connection portion 2e. The isolator air discharge valve 209 is closed during this process. The disinfectant from the isolator 208 continues to the cooling water output 2a of the water preparation module 200 to close the disinfectant circulation loop.

The patient output heat exchanger 314 is configured such that when the patient output heat exchanger pump 316 is in the inoperative state and the patient output heat exchanger drain valve 318 is in the open state and fluid is in the cooling water output section 2a, The disinfectant can be drained by subsequently opening the isolator air discharge valve 209 and the air bleed valve 320 while circulating between the return connection portions 2b.

The air passage between the degassing chamber 224 and the isolator 208 is disinfected by closing the isolator air discharge valve 209 and opening the bypass valve 226 for degassing. Next, the degassing pump 222 is operated in a state where the reverse osmosis pump 236 is off, so that only the flow from the degassing chamber 224 is guided to the isolator 208 through the air passage .

At the end of the disinfection process, the disinfectant selector valve 256 is returned to its original default position with the first reverse osmosis bypass valve 250 still open. The disinfectant is passed through the first reverse osmosis membrane unit 238 and the second reverse osmosis membrane unit 252 by the first reverse osmosis pump 236 and then through the second reverse osmosis output throttle valve 254 and the disinfectant selection valve 256 1 < / RTI > reverse osmosis pump < RTI ID = 0.0 > 236 < / RTI > After this circulation, the first reverse osmosis membrane bypass valve 250 is closed, the heat discharge connection valve 520 in the drain module 500 is opened, and the disinfectant is discharged to the heat discharge connection portion 13a through the cleaning waste connection portion 2d. And from the external drain connection 16.

Finally, the water preparation module 200 is flushed with water to remove any residual disinfectant along the disinfectant path described above.

From the foregoing, it will be appreciated that the entire water preparation module 200 from the water softener 206 to the second RO membrane 252 and including the unit is chemically disinfected by this process.

On the downstream side of the second RO membrane 252, the water having the disinfecting temperature supplied from the reverse osmosis membrane disinfecting connection part 3 is used for disinfecting the fluid path between the second RO membrane 252 and the purified water connecting part 2c . In this case, the water from the tap connection 1 passes through the water preparation module 200 along the normal purification fluid path, and reverse osmosis water is generated at the output side of the second RO membrane 252. The mixed water stop valve 442 of the concentrate mixing module 400 is opened and a current is passed through the salt input volumetric pump 452 to draw water out of the mixed water supply connection portion 4a. The water supplied to the mixed water supply connection portion 4a of the mixing module 400 is drawn out from the purified water connection portion 2c of the water preparation module 200 and is heated to the disinfecting temperature by the disinfection heater 330. [ The salt input volumetric pump 452 pumps water at the disinfection temperature from the reverse osmosis membrane disinfection valve 499 in the open state to the output side of the second RO unit 252 through the reverse osmosis membrane disinfection connection unit 3. Thus, a closed recycle loop of water at disinfection temperature is provided, the temperature of which is monitored by a second reverse osmosis temperature sensor 264.

The sterilization heat exchanger bypass valve 328 is disinfected as part of the thermal sterilization loop by opening the valve so that hot sterilized water passes through the valve.

The high temperature water is supplied to the drain module 500 by disabling the salt input positive displacement pump 452 and operating the flow control pump 446 to pump the hot water through the mixing module drain connection 15 to the drain module 500 500).

The manifold 404 and cap 406 are thermally disinfected before the disposable concentrate container 402 is connected to the manifold 404. To accomplish this, the cap 406 is disposed on the manifold 404 to form a sealed cavity. The flow control pump 446 is operated to pump the water heated to the disinfecting temperature through the disinfecting heater 330 through the mixed water supply connection 4a. The flow control pump 446 pumps the disinfected water through the reservoir fill valve 466 into the concentrate reservoir 468. The hot disinfectant fluid is injected into the cavities formed by the manifold 404 and the cap 406 in a timely manner through the reservoir exhaust disinfection valve 498, the reservoir output valve 470, the respective salt input valves 478-488 ) To sterilize all these valves. The cap air discharge valve 474 discharges air from the cavity formed by the manifold 404 and the cap 406 to the drain module 500 through the mixing module drain connection 15. Once the manifold 404 and cap 406 are filled with a high temperature disinfection fluid, the fluid is forced through the mixing module drain connection 15 to the drain module 500 via the cap air discharge valve 474.

In the drain module 500, the hot fluid exits the heat recovery drain connecting portion 13b and passes through the sterilization heat exchanger 326. [ However, since the disinfection heat exchanger bypass valve 328 is in an open state, the disinfection fluid that has passed through the sterilization heat exchanger 326 and returned to the drain module 500 via the heat recovery drain return connection portion 13c, No heat is lost. In this way, the heat recovery drip connection portion 13b and the heat recovery return valve 532 are also thermally sterilized.

To disinfect the sodium bicarbonate air discharge valve 492, the water at the disinfection temperature coming from the heat control and sterilization module 300 is withdrawn through the mixed water supply connection 4a by the salt input volumetric pump 452. At this time, only the open fluid passages formed by the manifold 404 and the cap 406 into the filled cavity pass through the sodium bicarbonate air discharge valve 492 and the sodium bicarbonate input valve 482. Accordingly, as the salt input positive displacement pump 452 pumps the hot water from the cavity formed by the manifold 404 and the cap 406 through the sodium bicarbonate air discharge valve 492, (4a) via the sodium bicarbonate air discharge valve (492). The sodium bicarbonate air discharge valve 492 is toggled to disinfect the air exhaust and fluid channel 428. The high temperature water is recirculated through this loop by closing the heat recovery return valve 532 in the drainage module 500 and opening the mixed water stop valve 442. The same method can be used to sterilize the sodium chloride air discharge valve 494 and the sodium chloride input valve 484.

The fluid path leading to the glucose compartment 420 of the disposable concentrate container 402 is connected to the mixing system bypass valve 440 through the mixed water supply connection 4a from the thermal control and sterilization module 300, Is then sterilized using a glucose selector valve 444 and a glucose input valve 490 using a flow control pump 446 that pumps into the cavity formed by the manifold 404 and the cap 406. Then, with the flow control pump 446 shut off, the glucose recycle pump 448 is used to recycle the hot water through the glucose output channel 436 and the fluid input channel 434. The glucose input valve 490 is closed at this stage. Finally, the hot disinfection fluid may exit the cavity formed by the manifold 404 and the cap 406 through the cap air discharge valve 474 and the mixing module drain connection 15.

After disinfection, the manifold 404 and the cap 406 connect the cavity formed by them to the cap air discharge valve 474 at the air outlet 6 and to the cap air outlet valve 474 using the salt input volumetric pump 452 The water is drained by pumping water from the manifold and cap 406 through the reservoir drain disinfecting connection 498, the concentrate reservoir 468, and the reservoir output valve 470. The salt input volumetric pump 452 pumps the water to the drain module via the flow control pump bypass valve 458, the drain disinfection valve 464 and the mixing module drain connection 15.

The hot water is supplied from the disinfecting heater 33 to the mixed water supply connection portion 4a and the mixed water supply connection portion 440 by the volumetric pump 352 in order to sterilize the thermal control and sterilization module 300 and the cyclic and sterilizable connector module 600, The mixed system bypass valve 440 and the mixing module output connection 4b through the OLA input valve 356. In a further route, the disinfecting fluid is pumped through the OLA sterilization valve 376. The sterilization fluid is passed through the thermal control and sterilization module 300 to the sterilization fluid connection 8a and then to the chamber 632 of the sterilizable connector 604 and the fluid passageway The sterilization bypass valve 614 and the sterilization heat recovery bypass valve 618 to the drainage module 500 via the peripheral pressure drainage connection part 14b.

In a further disinfection route, the disinfectant fluid entering the cycler and sterilizable connector module 600 through the sterilization fluid connection 8a passes through the patient bypass valve 616 and passes through the sterilization output connection 8b And passes through sterilizing heat exchanger 378. At this time, there is no fluid flow through the other side of the sterilization heat exchanger 378, and thus no heat is lost from the sterilization fluid while the fluid is passing through the sterilization heat exchanger 378. Disinfectant fluid entering the cyclic and sterilizable connector module 600 via the sterile fluid return connection 8c is sent to the drain module 500 via the peripheral pressure drain connection 14b.

At the final disinfection route through the cycler and the sterilizable connector module 600, the hot disinfecting fluid exiting the sterilization fluid connection 8a passes through the patient inlet valve 602, sterilizable connector 604, Through the first patient draining valve 608 to the negative pressure discharge connection portion 14a. At this time, the drain pump 508 is in an operating state.

From the foregoing, it will be appreciated that the entire fluid system, including the drain module 500, and from the water softener 206 to the patient pinch valve 626, can be disinfected chemically or by thermal disinfection.

Cleaning and flushing

After disinfection, the disposable concentrate container 402 is connected to the manifold 404 and the downstream cleaning operation is performed.

The reverse osmosis water preheated to the mixing temperature by the disinfection heater 330 is withdrawn by the salt input volumetric pump 452 via the mixed water stop valve 442 into the concentrate mixing module 400 And is directed through the detergent input valve 480 into the detergent compartment 410 of the disposable concentrate container 402. Sufficient water is pumped into the detergent compartment 410 to dissolve any powdered detergent stored in the compartment. Once the detergent has dissolved, the salt input volumetric pump 452 is reversed to withdraw the detergent solution from the detergent compartment 410 through the detergent input valve 480. The detergent is pumped into the concentrate reservoir 468 via a reservoir fill valve 466 by a salt input volumetric pump 452. The detergent is sent from the concentrate storage 468 to the drain module 500 via the storage air outlet valve 496 and the mixing module drain connection 15.

For cleaning the thermal control and sterilization module 300 and the downstream components in the cycler and sterilizable connector module 600 the cleaner is connected to a flow control pump bypass valve 458 by a salt input volumetric pump 452 And storage fill valve 466 to the mixing module output connection 4b. The flow of the detergent is guided through the thermal control and sterilization module 300 and the cycler and sterilizable connector module 600 according to any of the disinfection routes.

After cleaning, the thermal control and sterilization module 300 and the cycler and sterilizable connector module 600 are flushed with the purified water from the water preparation module 200 to remove residual detergent.

The detergent may be sodium carbonate, but other detergents such as citric acid or a precursor for a detergent may be used.

Treatment

Once the fluid system has been disinfected, cleaned and flushed, the first step in the treatment process is to dissolve the salt and glucose in the disposable container 402. The reverse osmosis water at the mixing temperature is then pumped into the salt compartments 412-418 by way of the mixed water stop valve 442 via the input valves 482-488 by the salt input volumetric pump 452, do. Sufficient water is pumped by the salt input volumetric pump 452 to fill each compartment 412-418 of the disposable concentrate container 402 but the fluid pumped by the salt input volumetric pump 452 Is carefully monitored such that too much water that is overflowed through the air discharge channels 424,428 is not introduced into the compartments 412-418. Once each compartment 412-418 is filled, each input valve 482-488 is closed while salt is dissolved. The volume of water entering the compartments 408, 412-418 is carefully selected. Thus, the control system knows how much water is in each compartment. When the water is introduced too much into the sodium bicarbonate compartment 412 or the sodium chloride compartment 414, the resulting solution is practically non-existent as it is still substantially saturated.

Reverse osmosis water at a mixing temperature of, for example, 37 ° C is supplied from the mixed water supply connection 4a by the flow control pump 446 to the mixing system bypass valve 440, the reservoir filling valve 466 , And is pumped into the fluid input channel 434 via the glucose selector valve 444 and the glucose input valve 490 in the open state. The glucose recycle pump 448 is deactivated at this stage. Once sufficient fluid is pumped into the glucose compartment 420 and the compartment is filled to a level that does not exceed the top of the glucose air outlet channel 432, the glucose input valve 490 is closed and the glucose recycle pump 448 is filled with glucose The solution is recirculated to aid dissolution. The volume of water pumped into the glucose compartment 420 determines the concentration of the glucose solution.

While the glucose and salt are dissolved, the patient fluid circuit is sterilized. The reverse osmosis water is pumped from the mixed water supply connection 4a through the mixing system bypass valve 440 and the mixing module output connection 4b by the positive displacement pump 352 and is pumped from the OLA sterilization valve 376 do. The water passes through a sterile heat exchanger 378 where the water is preheated and then passes through a second OLA heat exchanger 362 for further preheating. The volumetric pump 352 compresses the water to a sufficiently high forward force so that the OLA heating tank 364 does not boil the water at a suitable sterilization temperature, Raise to 121 ° C or higher. The heated and compressed water passes through the high temperature side of the second OLA heat exchanger 362 and the first OLA heat exchanger 360. However, since there is no flow through the low temperature side of the first OLA heat exchanger 360, no heat is transferred from the heated and compressed water. Similarly, as the heated and compressed water passes through the patient output heat exchanger 314, no heat is transferred because the bath in the patient output heat exchanger 314 has been drained. The heated and compressed water passes through the patient output pressure relief valve 374 which is inactivated to prevent pressure drop and enters the cycler and sterilizable connector module 600 through the aseptic fluid connection 8a.

In the cycler and sterilizable connector module 600, the heated and compressed water is first introduced into a patient dispensing valve 602, a sterilizable connector 604, a patient drain off valve 606, a sterilization bypass valve 614 and sent to the sterilizing output connection 8b. The first patient drain valve 608 is closed during this operation to protect the patient drain pressure sensor 610 from the high temperature and protect the output volumetric flow meter 650 from the high temperature. Therefore, the fluid path between the first patient drain valve 608 and the drain module 500 is not sterilized. However, this line is disinfected and there is no risk to the patient since it does not handle the fluid that is sent to the patient at a later date. From the sterilization output connection 8b, the heated and compressed water passes through a sterilizing heat exchanger 378 where the temperature of the water is transferred to the relatively low temperature water passing through the OLA sterilization valve 376 And the temperature is reduced. Next, the cooled and compressed water passes through a sterilizing pressure relief valve 620 which reduces the pressure to atmospheric pressure via a sterilizing fluid return connection 8c. The water of the cooled ambient pressure passes through the disinfection return shutoff valve 622, the peripheral pressure drain connecting portion 14b and the heat recovery drain connecting portion 13b and is sent to the disinfecting heat exchanger 326. In the heat exchanger, The temperature is further reduced before being sent to the external waste connection portion 16 via the heat recovery drain return connection portion 13c and the heat recovery return valve 532. [

During the further sterilization of the cycler and sterilizable connector module 600, the patient inlet valve 602 and the sterilization bypass valve 614 are closed such that the hot compressed water passes through the patient bypass valve 616 (Which is now open) to the sterile output connection 8b to sterilize the patient bypass valve 616.

In the manner described above, it is ensured that the fluid circuit from the OLA heating tank 364 to the sterilizing heat exchanger 378 is sterile. This sterility is maintained throughout the treatment period.

Once the fluid path from the OLA 375 to the sterilizable connector 364 has been sterilized, the sterile fluid is passed along the path continuously until the end of the treatment period to maintain sterility. This fluid may be water from the water preparation module 200 which is passed from the mixed water supply connection 4a through the mixing system bypass valve 440 to the mixing module output connection 4b and the OLA 375 Where the water is sterilized and passed to the drain module 500 through the patient bypass valve 616 and the sterile heat recovery bypass valve 618. [ Alternatively, the fluid may be fluid from the concentrate mixing module 400, which is sterilized in the OLA 375 and sent to the drain module 500 along the same fluid path as described above. In this way, the OLA 375 operates without overheating and can ensure sterility throughout the treatment period. When the PD fluid is delivered to the patient, the patient bypass valve 616 is shut off and the patient inlet valve 602 is opened to allow the PD fluid to be sent to the sterilizable connector 604. [

Once the sterilization operation is terminated, the enriched PD fluid is mixed in the concentrate reservoir 468 in the manner described above with respect to the concentrate mixing module 400.

During the mixing of the concentrated PD fluid, the bath of the patient output heat exchanger 314 opens the air bleed valve 320 and pumps the patient output heat exchanger pump 316, in preparation for sending the PD fluid to the patient To be filled.

The device is now ready for the arrival of the patient. When the patient arrives, the membrane 634 on the disposable fluid line 10 is punctured by the sterilizable connector 604. The disposable fluid line 10 is primed by using a positive displacement pump 352 to pump the PD fluid (or aseptic water) from the mixing module output connection 4b through the OLA input valve 356. The PD fluid is diluted by the salt input volumetric pump 452 with the purified water flow from the receiving module 200 to the concentrated PD fluid pumped from the concentrate storage 468 into the mixing chamber 450 Is generated in the mixing module (400). The flow control pump 446 is bypassed by opening the flow control pump bypass valve 458 during delivery of the PD fluid. The PD fluid passes through the first OLA heat exchanger 360, the second OLA heat exchanger 362, and the OLA heating tank 364 to be sterilized. The sterilized PD fluid is lowered to the required patient temperature by the patient output heat exchanger 314 and depressurized by the patient output pressure relief valve 374. The aseptic PD fluid then passes through the patient inlet valve 602 and the patient pinch valve 624 into the disposable dialysis line 10. The PD fluid passes through the disposable fluid line 10 and returns to the aseptic connector 604 via the second patient pinch valve 624. This returned fluid passes through the patient drain valve 606 and the first patient drain valve 608. The output volumetric flow meter 650 records the flow of fluid and confirms that the disposable fluid line 10 has been successfully primed by the PD fluid. Next, the PD fluid is sent to the drain module 500 via the drain connection portion 14a of negative pressure. In this way, it is ensured that only a minimal amount of air is present in the disposable dialysis line connected to the patient ' s multiple membrane.

Once the disposable fluid line 10 has been primed, the patient is connected to the disposable fluid line 10 so that the fluid in the patient's abdominal cavity can be drained. During the patient's drainage process, the drain pump 508 transfers the dialysis fluid from the sterilizable connector 604 through the patient drain off valve 606 to the negative displacement drain connection 14a through the output volumetric flow meter 650, Respectively. The output volumetric flow meter 650 records the volume of the dialysis fluid withdrawn from the patient's abdominal cavity. During the drainage, a sample of the patient dialysate may be taken by the sampling module 700.

In the case of later filling and draining the patient's abdominal cavity, during the drainage of the patient by the cycler and sterilizable connector module 600 and the drain module 500, the concentration in the concentrate reservoir 468 to the mixing module 400 The additional concentrated PD fluid is mixed.

When the patient's abdominal cavity recorded by the drop or pressure of the pressure detected by the patient drain pressure sensor 610 or the output volumetric flow meter 650 is empty or when a predetermined drainage time has elapsed, 508 are stopped. Next, the patient's multiple-membrane steel flows from the aseptic fluid connection 8a of the thermal control and sterilization module 300 through the patient inlet valve 602, sterilizable connector 604 and patient pinch valve 624, PD fluid. During infusion into the patient, the pressure of the PD fluid entering the patient is monitored using the pressure taps described above with respect to the cycler and the sterilizable connector module 600. The volume of the PD fluid entering the patient's peritoneal cavity is recorded by the input volumetric flow meter 350.

Once sufficient fluid has been sent to the patient, the fluid system downstream of the mixing module output connection 4b is first flushed to the drain module 500 with the remaining (sterilized) PD fluid, then sterilized water, ) To remove the glucose deposits that remain and become caramelized. Thus, the cycle of draining and filling can be repeated for an extended period of time to complete the treatment period.

At the end of the treatment period, once the patient has disconnected from the device 100, any residual salt or glucose solution in the disposable concentrate storage 402 is passed through the mixing module drain connection 15, Lt; / RTI > Next, the fluid system is flushed with clean water using the disinfection route described above. The disposable concentrate container 402 and the disposable fluid line 10 are replaced. Finally, the system is cleaned and flushed with clean water, as described above, before the system is stopped by closing the inlet valve 202, the heat discharge connection valve 520 and the heat recovery return valve 532. Next, the device is in a ready state for the next treatment period.

During extended periods of unused use, the entire fluid system may be filled by the engineer with suitable preservatives and closed against the atmosphere to prevent bacterial growth.

The device has been described as having a memory mechanism capable of storing information for later retrieval. Such a memory mechanism may be a hard disk or a solid state memory mechanism. The variables stored in the technical log include, but are not limited to: time and results of treatment such as cleaning, sterilization, aseptic conditions, etc.; flux; Condition of valve and pump; Pump speed; Conductivity, temperature, pressure, and the like.

It will be apparent to those skilled in the art that various modifications and variations can be made in the structure and methodology of the present invention without departing from the scope or spirit of the invention. For example, certain aspects of the structure and methodology of the invention specifically described in connection with peritoneal dialysis include hemodialysis or hemofiltration or hemofiltration or other medical fluid generation or treatment procedures (including producing nutrients) May be used for long-term (chronic) dialysis, home dialysis, acute dialysis, especially for infusion and / or removal of fluid to and / or from a patient. Accordingly, it is to be understood that the invention is not limited to the examples described above and illustrated in the drawings. Instead, the present invention is intended to embrace such variations and modifications as fall within the scope of the following claims and their equivalents.

Claims (143)

A container for use in a device for producing peritoneal dialysis fluid, the container comprising a plurality of chambers each containing a respective concentrate of peritoneal dialysis fluid. The container of claim 1, wherein at least one of the chambers contains at least one powdery concentrate. The container of claim 1, wherein at least one of the chambers contains a predetermined amount of concentrate that is not completely soluble when the liquid is filled in the at least one chamber in a single step. The container of claim 1, wherein at least one of the chambers contains powdered glucose and at least the other of the chambers contains a substantially dry form of inorganic salt. A container that contains all the concentrates in a concentrated form that provide a sufficient peritoneal dialysis fluid for the peritoneal dialysis treatment when mixed with water. A container for use in a dialysis fluid producing apparatus, the container comprising at least one chamber for containing a detergent and at least one other separate chamber for containing a powdered inorganic salt. A container for containing a concentrated component of a dialysis fluid, wherein at least two separate chambers are formed therein, each chamber containing a different inorganic salt, the volume of each chamber and the amount of inorganic salt contained in each chamber being Wherein the volume of the solution is such that the conductivity of the solution so prepared is different in volume and amount when the solution of the salt is prepared by filling each chamber with a liquid. A plurality of discrete chambers for receiving the concentrated components of the dialysis fluid, At least one connector associated with each chamber Wherein each connector includes at least two separate flow channels to enable simultaneous entry and exit of each chamber. 9. The container of claim 8, wherein the at least two distinct channels are concentrically disposed in each connector. 9. The container of claim 8, wherein at least one of the chambers includes two connectors, one of which includes the at least two separate flow channels and the other has another flow channel. 9. The container of claim 8, wherein the connector is provided in a lower region of the chamber, wherein one of the flow channels of the at least one connector includes a portion extending into the upper region of the chamber. 9. The container of claim 8, wherein one of the flow channels of each chamber is provided with a diffuser to diffuse liquid inflow into the chamber. 9. The container of claim 8, wherein the connectors are aligned with one another along a linear axis. 14. The container of claim 13, wherein the linear axes of the mutually aligned connectors are offset from a central axis of the container. CLAIMS What is claimed is: 1. A container for use in priming powdered glucose at a patient ' s treatment site, the container comprising: an inlet port of a subcontainer region for receiving feed water to dissolve the powdered glucose in the container and the powdered glucose in the container Wherein the inlet port is provided with a diffuser configured to diffuse a water stream in the powdered glucose. A container for a concentrated component of a dialysis fluid, comprising: a plurality of discrete chambers formed therein; and at least one connector associated with each chamber, wherein the connectors are aligned with one another along a linear axis. As universal containers for patients with different dialysis treatment conditions, A plurality of compartments capable of mixing with the liquid to form a dialysis solution and containing a sufficient amount of chemical components to form a plurality of different dialysis solution preparations for the prescription of a plurality of other patients, The compartments being in fluid communication with the dialysis treatment system, Lt; / RTI > container. 18. The system of claim 17, wherein said container comprises a first compartment, a second compartment, a third compartment, a fourth compartment, a fifth compartment, a first port in flow communication with said first compartment, A third port in flow communication with the third compartment, a fourth port in flow communication with the fourth compartment, a fifth port in flow communication with the fifth compartment, A first chemical composition contained in the first compartment and capable of mixing with the liquid to form a first component of the dialysis solution; and a second chemical composition that is contained in the second compartment and can be mixed with the liquid to form a second component of the dialysis solution A third chemical composition contained in the third compartment and capable of mixing with the liquid to form a third component of the dialysis solution; and a second chemical composition contained in the fourth compartment, A fourth chemical composition capable of forming a fourth component of the dialysis solution, A fifth chemical composition which is contained in a fifth compartment and is capable of mixing with a liquid to form a fifth component of a dialysis solution, said first, second, third, fourth and fifth chemical compositions comprising Wherein the container is provided in an amount sufficient to satisfy a prescription of a plurality of other patients. 18. The container of claim 17, wherein the amount of the chemical component is such that a substantial amount of at least one chemical composition is not part of the dialysis solution and is not infused into the patient. As a container used in a dialysis system, A first compartment for containing calcium chloride, A second compartment for containing magnesium chloride, A third compartment for containing sodium chloride, A fourth compartment accommodating the cleaning agent, A fifth compartment for containing sodium bicarbonate, A sixth compartment for containing glucose, A plurality of ports associated with the compartments and connectable to the dialysis treatment unit at the patient treatment site to enable dialysis liquid to be configured at the patient treatment site Lt; / RTI > 21. The method of claim 20, wherein the contents of the at least some of the compartments are substantially dry, and at least some of the plurality of ports are adapted to receive the moving liquid to mix with the substantially dry form of the contents to form a solution in each compartment. The container being configured. 21. The container of claim 20, further comprising a seventh compartment for receiving lactic acid. 21. The container of claim 20, wherein the container is provided with a readable indicia configured to be recognized by the dialysis treatment unit. 21. The container of claim 20, wherein the compartments accommodate individual contents in an amount sufficient to allow the container to meet one of a plurality of patient prescriptions. As a container used in a dialysis system, At least one containing one ionic component of the solution and one having at least one type of detergent for use in cleaning the channel of the dialysis system and a plurality of compartments for containing precursors of the detergent, A plurality of ports on the vessel for placing the compartments in fluid communication with the dialysis system; Lt; / RTI > 26. The method of claim 25, wherein the compartments comprise a first compartment containing calcium chloride, a second compartment containing magnesium chloride, a third compartment containing sodium chloride, a fourth compartment containing the detergent, A fifth compartment, and a sixth compartment containing the glucose. 27. The container of claim 26, wherein the compartments further comprise a seventh compartment for receiving lactic acid. As a container used in a dialysis system, A plurality of compartments, each containing a chemical composition for dialysis treatment, A plurality of ports in fluid communication with said compartments for bringing said compartments in fluid communication with said dialysis system, Lt; / RTI > Wherein at least one of the ports is disposed along a surface of the container such that the at least one port is asymmetric with respect to the longitudinal axis of the surface of the container. 29. The container of claim 28, wherein the axes of the ports are aligned. 29. The container of claim 28, further comprising a respective diaphragm on each port, the diaphragm configured to be perforated by a respective connector on the dialysis system. 29. The container of claim 28, wherein at least some of the ports include flanges that can be coupled to a mounting on the dialysis system. 29. The container of claim 28, wherein the free ends of the ports are coplanar. 29. The method of claim 28, wherein the plurality of compartments comprises a first compartment containing calcium chloride, a second compartment containing magnesium chloride, a third compartment containing sodium chloride, a fourth compartment containing the detergent, A fifth compartment accommodating the first compartment and a sixth compartment accommodating the glucose. 34. The container of claim 33, wherein the compartments further comprise a seventh compartment for receiving lactic acid. 29. The container of claim 28, wherein the outer surface of the container comprises a bar code symbol configured to be read by the bar code reader on the dialysis system. 29. The container of claim 28, wherein at least some of the compartments have separate vent tubes. 29. The apparatus of claim 28, wherein at least some of the ports include a first flow path for moving air into each compartment, and a second flow path for moving the liquid into each compartment and removing solution from the respective compartment Container. As a container used in a dialysis system, A plurality of compartments, each containing a chemical composition used for dialysis treatment, A plurality of ports in fluid communication with the compartment, A readable indicia on said container indicative of the contents of the compartment; Lt; / RTI > 42. The container of claim 38 wherein the readable indicia is a bar code symbol. 39. The container of claim 38, wherein the readable indicia comprises information about the contents of the compartment. 42. The container of claim 38 wherein the readable indicia comprises patient prescription information. 39. The system of claim 38, wherein said compartment comprises a first compartment containing calcium chloride, a second compartment containing magnesium chloride, a third compartment containing sodium chloride, a fourth compartment containing a detergent, A fifth compartment, and a sixth compartment containing the glucose. 43. The container of claim 42, wherein the compartment further comprises a seventh compartment for receiving lactic acid. As a container used in a dialysis system, A first compartment including a first air discharge channel and a first fluid channel, A second compartment comprising a second air discharge channel and a second fluid channel, A third compartment including a third air discharge channel and a third fluid channel, A fourth compartment including a fourth air discharge channel, a fluid input channel, a diffuser in flow communication with the fluid input channel, a fluid output channel and a glucose filter in fluid communication with the fluid output channel, A fifth compartment including a fifth air outlet channel and a liquid channel, A sixth compartment including a first air discharge / fluid flow channel and a first fluid input / output channel, A seventh compartment including a second air discharge / fluid flow channel and a second fluid input / output channel, A first port in fluid communication with the first air discharge channel and the first fluid channel, A second port in fluid communication with the second air discharge channel and the first fluid channel, A third port in fluid communication with the third air discharge channel and the third fluid channel, One pair of fourth ports in fluid communication with the fluid input channel and the fluid output channel and the other in fluid communication with the fourth air discharge channel, A fifth port in fluid communication with the fifth air outlet channel and the liquid channel, A sixth port in fluid communication with the first air discharge / fluid flow channel and the first fluid input / output channel, And a seventh port in fluid communication with the second air discharge / fluid flow channel and the second fluid input / Lt; / RTI > Wherein the plurality of compartments are sized to receive a respective amount of dialysis solution component capable of fulfilling a plurality of different dialysis solution prescriptions and the ports can be placed in fluid communication with the dialysis processor. 45. The method of claim 44, Calcium chloride in the first compartment that can be mixed with the liquid to form a first component of the dialysis solution, The lactic acid in the second compartment being able to mix with the liquid to form a second component of the dialysis solution, A cleaning agent in the third compartment that can be mixed with the liquid to form a clean solution, Liquid in the fourth compartment, which is capable of forming a third component of the dialysis solution by mixing with the liquid and is in a substantially dry form, Magnesium chloride in the fifth compartment that can be mixed with the liquid to form a fourth component of the dialysis solution, Sodium bicarbonate in the sixth compartment that can be mixed with the liquid to form a fifth component of the dialysis solution, Sodium chloride in the seventh compartment which can be mixed with the liquid to form the sixth component of the dialysis solution Further comprising a container. An apparatus for generating a peritoneal dialysis fluid for introduction into a patient ' s complex membrane at a treatment site, A plurality of chambers respectively containing concentrates of peritoneal dialysis fluid components, A fluid mixer configured to mix said concentrate with a liquid to produce a peritoneal dialysis fluid, A sterilizer configured to sterilize at least one of the liquid and the peritoneal dialysis fluid; A patient inlet connection configured to fluidically transmit the peritoneal dialysis fluid to a patient ' Wherein at least one of the concentrates is substantially in a dry form and is at least partially dissolved when used in the apparatus to form a portion of the dialysis fluid. 47. The apparatus of claim 46, wherein the concentrate in one of the chambers is a substantially dry form of osmotic agent. 49. The apparatus of claim 47, wherein the osmotic agent is glucose. 47. The apparatus of claim 46, wherein each concentrate is a single concentrate. 47. The apparatus of claim 46, wherein each chamber contains a separate component of a peritoneal dialysis fluid selected from sodium chloride, sodium bicarbonate, magnesium chloride, calcium chloride, sodium lactate, lactic acid, and glucose. 51. The method of claim 50, wherein the concentrate comprises sodium chloride in a substantially dry form, sodium bicarbonate in a substantially dry form, magnesium chloride in a substantially dry form, calcium chloride in a substantially dry form, lactic acid solution, substantially dry form of glucose Lt; / RTI > 47. The apparatus of claim 46, further comprising a chamber for receiving a cleaning agent. 47. The apparatus of claim 46, further comprising a controller to control the fluid mixer to selectively produce a peritoneal dialysis fluid selected from the group of different formulations. 54. The apparatus of claim 53, wherein the concentrate comprises a plurality of types of electrolytes, and wherein the controller is operable to selectively generate a peritoneal dialysis fluid formulation having different relative electrolyte concentrations from each other. 54. The apparatus of claim 53, wherein the controller comprises data input means for receiving prescription information of a patient. 47. The apparatus of claim 46, wherein the apparatus is configured to prime the liquid comprising water in the at least one concentrate in a substantially dry form in each chamber, the amount of concentrate in the chamber and the dimensions of the chamber, Such that the concentrate only partially dissolves when it is charged, the apparatus comprising a flow line for removing the liquid comprising the dissolved concentrate from the chamber, Further comprising a flow line for adding substantially simultaneously to said chamber. 56. The apparatus of claim 56, wherein the flow line for removing concentrate is used during priming to inject liquid containing water into the chamber, and wherein the liquid addition flow line is used during priming to vent air from the chamber. 56. The apparatus of claim 56, wherein the at least one concentrate in the partial dissolution chamber is selected from sodium chloride and sodium bicarbonate. 57. The apparatus of claim 56, wherein the apparatus is configured to prime the liquid comprising water in the least one type of concentrate in a substantially dry form in each chamber, the amount of concentrate in the chamber and the dimensions of the chamber Wherein the volume and dimension are such that when the liquid is filled, the concentrate is completely dissolved. 61. The apparatus of claim 59, wherein the at least one concentrate in the substantially dry form is selected from the group consisting of magnesium chloride and calcium chloride. 47. The method of claim 46, wherein the at least one type of concentrate in the substantially dry form comprises at least a first and a second concentrate in a substantially dry form, Wherein the first concentrate is in a first chamber and the apparatus is configured to priming a liquid comprising water in the first concentrate in a substantially dry form and wherein the amount of the first concentrate in the first chamber and the The dimensions of the chamber are such that the first chamber is only partially soluble in the first concentrate when the liquid is filled and the apparatus is adapted to remove the liquid containing the dissolved concentrate from the first chamber And a flow line for substantially simultaneously adding the same amount of liquid to the first chamber to the liquid to be removed, The second concentrate being in a second chamber, the apparatus being configured to priming a liquid comprising water in the second concentrate in a substantially dry form, the amount of the second concentrate in the second chamber and the second concentration in the second chamber, Wherein the dimensions of the chamber are such that the second chamber is completely melted when the liquid is filled. 47. The method of claim 46, wherein each chamber receives an osmotic agent, wherein the apparatus introduces a liquid comprising water into the osmotic chamber, removes liquid containing the dissolved osmotic agent from the osmotic chamber, And a flow circuit for reintroducing a liquid comprising an osmotic agent into the osmotic chamber. 63. The apparatus of claim 62, further comprising a heater for heating the liquid as the liquid comprising the dissolved osmotic material circulates through the flow circuit. 63. The apparatus of claim 62, further comprising an exhaust section allowing the gas to escape as the liquid comprising the dissolved osmotic agent circulates through the flow circuit. 63. The apparatus of claim 62, wherein the osmotic agent comprises glucose. 47. The apparatus of claim 46, wherein the sterilizer is a thermosyzer that sterilizes the peritoneal dialysis fluid at elevated temperatures. 65. The apparatus of claim 66, wherein the thermosister is installed downstream of the fluid mixer. A system for forming a dialysis solution by priming a substantially dry form of glucose at a patient treatment site, A plurality of compartments for receiving the chemical composition used to form the dialysis solution, one of the compartments having a plurality of compartments for receiving glucose in a substantially dry form, And a mixing module / RTI > Wherein the mixing module includes a plurality of flow paths that are in fluid communication with the compartment and at least one of the flow paths is configured to transfer a liquid into a glucose containment chamber to form a glucose solution, And a mixing chamber for mixing the liquid and the contents of the compartments to form a dialysis solution. 69. The system of claim 68, wherein the glucose containment compartment comprises a diffuser to facilitate the dissolution of dry glucose in the liquid. A method of peritoneal dialysis treatment using a dialysis fluid generated at a patient's treatment site, Each comprising a plurality of compartments, each containing a different component of a dialysis fluid, wherein at least one of the components is in a substantially dry form; At a patient treatment site, mixing a liquid with at least some of the components to produce a component solution, Forming a dialysis fluid in the dialysis apparatus at a patient treatment site, the method comprising: a dialysis fluid forming step of mixing the component solution; Causing the dialyzer to communicate with the peritoneal fluid of the patient, Flowing a dialysis fluid into the multiple membrane cavity, Withdrawing the dialysis fluid from the multiple membrane steel ≪ / RTI > 54. The method of claim 70 wherein at least one component of said substantially dry form comprises an osmotic agent. 71. The method of claim 71, wherein the osmotic agent is glucose. 69. The method of claim 70, further comprising: flowing tap water to the dialysis device; and purifying the tap to produce purified water, wherein the liquid comprises at least purified tap water. 69. The method of claim 70, further comprising sterilizing at least one of the liquid and the dialysis fluid in the dialysis device. 69. The method of claim 70, wherein the dialysis device comprises a processor and a removable container in which a plurality of components are disposed, the method comprising: flowing the container to the processor at the beginning of a treatment period; ≪ / RTI > further comprising removing said vessel from said processor. 69. The method of claim 70, wherein the step of forming a dialysis fluid comprises sensing a concentration of the chemical composition in the component solution and adjusting the flow rate of the component solution into the mixing chamber based on the sensing. A method for providing a medical aqueous solution from a plurality of kinds of concentrates, Providing at least one concentrate in a separate chamber in a substantially dry form, Priming at least one concentrate of said substantially dry form with a liquid comprising water to form at least one dissolved concentrate, Transferring the at least one type of dissolved concentrate to a mixed vessel via a flow conditioner associated with the concentrate, Adjusting a flow conditioner associated with the at least one dissolved condensate to move the concentrate of the metered volume through the flow conditioner; Measuring the concentration of the concentrate to measure the amount of the concentrate supplied to the mixed vessel; Terminating the supply of the concentrate when a predetermined amount has been supplied ≪ / RTI > 77. The method of claim 77, further comprising: adjusting a first flow regulator associated with the first concentrate such that the first concentrate flows through the first flow regulator at a metered flow rate; Measuring the concentration of the first concentrate to measure the concentration of the first concentrate; terminating the supply of the first concentrate when a predetermined amount is supplied; and flowing the second concentrate through the second flow controller at the metered flow rate Measuring the concentration of the second concentrate to determine the amount of the concentrate to be fed to the mixed vessel, and measuring the concentration of the second concentrate when the predetermined amount is supplied Terminating the supply of the second concentrate, repeating the adjustment, movement, measurement and termination procedures for each further concentrate to obtain a predetermined amount ≪ / RTI > wherein each concentrate comprises an aqueous solution of each concentrate. 77. The method of claim 77, wherein the metered volume is moved by a pump and the pump is also used to sequentially pump each concentrate into the mixing chamber. 77. The method of claim 77, further comprising using the same measurement means to sequentially measure the concentration of each concentrate. 77. The method of claim 77, further comprising diluting the concentrate before at least one of the concentrate leaves each chamber and before it is transferred to the mixed vessel. The method of claim 81, further comprising: moving at least one concentrate by a pump at a metered flow rate along a concentrate flow line; moving water by a second pump at a metered flow rate along the flow line; Mixing said at least one concentrate supplied along a concentrate flow line with water supplied along said water line to provide a diluted concentrate. 83. The method of claim 82, further comprising: measuring the concentration of at least one of the at least one concentrate and the diluted concentrate; and controlling the pump to provide the dilution ratio needed to obtain the desired concentration of diluted concentrate ≪ / RTI > 81. The method of claim 81, further comprising: moving the diluted concentrate to the mixed vessel at a predetermined flow rate; measuring the concentration of the diluted concentrate; multiplying the measured concentration by the flow rate; Accumulating the result of the multiplication to obtain a total amount of the concentrate supplied to the mixed vessel; and terminating the transfer of the diluted concentrate to the mixed vessel when a predetermined amount of the concentrate is supplied to the mixed vessel Further comprising the steps of: 77. The method of claim 77, further comprising measuring at least one of the properties of the concentrate and the properties of the concentrate after dilution at each chamber downstream, and determining from the measurement results whether the concentrate is a concentrate predicted in the chamber How it is. 78. The method of claim 77, further comprising: moving liquid in the mixed bevel toward a point of use; and diluting the liquid downstream of the mixing vessel. 99. The method of claim 86, further comprising measuring the concentration of the concentrate in the diluted liquid using the same measuring means used to measure the concentration of the concentrate during the feed to the mixed vessel. 77. The method of claim 77, further comprising flushing the path between the liquid source and the flow regulator by pumping the liquid from the liquid source through the associated flow regulator by reversing the pumping direction after termination of the supply of the concentrate . At least one of which is configured to communicate with a plurality of chambers each containing a respective concentrate in a substantially dry form, the apparatus for producing a medical aqueous solution from a plurality of concentrates, At least one flow line configured to form the at least one dissolved concentrate by priming the at least one concentrate in a substantially dry form with a liquid comprising water, A mixed vessel configured to receive the at least one dissolved concentrate, A flow regulator associated with at least one dissolved concentrate, the flow regulator configured to transfer the concentrate to a mixed vessel; Measuring means configured to measure a concentration of the at least one dissolved concentrate; Measuring the concentration of the dissolved concentrate by the measuring means so as to supply a predetermined amount of the dissolved concentrate to the mixed vessel while the at least one dissolved concentrate of the metered volume is introduced into the associated flow regulator And a pump / RTI > 99. The method of claim 89, further comprising a flow conditioner associated with each concentrate, wherein, in use of the apparatus, in order to supply a predetermined amount of concentrate to the mixed vessel, the concentration of each concentrate is measured while the angle of the metered volume Wherein the concentrate is pumped to the mixing vessel via its associated flow regulator. The apparatus of claim 89, wherein the pump is configured to sequentially pump each concentrate in liquid form into a mixed vessel. The apparatus of claim 89, wherein the measuring means is configured to sequentially measure the concentration of each concentrate. 99. The apparatus of claim 89, wherein the apparatus is configured to dilute the concentrate before the concentrate exits the chamber and is sent to the mixing vessel. The system of claim 93 further comprising a concentrate flow line in which the concentrate is pumped at a metered flow rate by the pump and a water flow line in which water is pumped at a metered flow rate by the second pump, Is coupled with a water flow line such that in use the diluent is mixed with the water to dilute the concentrate before it is sent to the mixing chamber. 93. The method of claim 94, wherein said measuring means is configured to measure a concentration of at least one of the concentrate and the diluted concentrate, and wherein, in use, the pump provides a dilution ratio needed to obtain the desired concentration of diluted concentrate Lt; / RTI > The apparatus of claim 93, wherein the apparatus is configured to deliver the diluted concentrate to the mixing vessel at a predetermined flow rate by the pump while measuring the concentration of the diluted concentrate by the measuring means, Multiplying the measured concentration by the flow rate, and multiplying the result of the multiplication with respect to time to obtain a total amount of concentrate fed to the mixed vessel; and when a predetermined amount of concentrate is fed to the mixed vessel, And terminating sending the concentrate to the mixing vessel. 99. The apparatus of claim 89, wherein the apparatus is configured to measure at least one of the properties of the concentrate and the properties of the concentrate after dilution on the downstream side of each chamber, and the apparatus determines from the measurement results whether the concentrate is a concentrate expected in the chamber And a checking mechanism for determining whether the device is in the non-contact state. 99. The apparatus of claim 89, further comprising a flow passage configured such that liquid in the mixed vessel is directed toward a point of use and is diluted downstream of the mixed vessel. 98. The apparatus of claim 98 wherein the measuring means used to measure the concentration of the concentrate delivered to the mixing vessel is also used to measure the concentration of the concentrate in the diluted liquid downstream of the mixing vessel. The pump of any one of claims 48 to 58, wherein the pump is reversible and connectable to a liquid source such that, upon use of the apparatus, after the delivery of the concentrate is terminated, the pump is reversed to withdraw the liquid from the liquid source And pumping through the associated flow regulator to flush the path between the liquid source and the valve. A dialysis solution manufacturing method for use during a dialysis treatment period for a patient, Providing a plurality of compartments containing an amount of a different chemical composition, Adding a liquid to the compartment to form a dialysis solution component in the compartment, From the components, a dialysis solution in an amount sufficient to complete the dialysis treatment period without using a portion of at least one of the components, Disposing of the unused portion of said at least one component ≪ / RTI > A method of forming a dialysis solution at a site of a treatment site of a patient, Adding a liquid to a compartment containing a plurality of different chemical compositions to form a chemical component solution for use in dialysis solution formation, The chemical component solution is flowed toward the mixing chamber, Monitoring at least one of a chemical component solution flowing toward the mixing chamber, Based on said monitoring, controlling the flow of at least one chemical component solution towards said mixing chamber ≪ / RTI > A method of forming a dialysis solution at a treatment site of a patient, Adding a liquid to a plurality of different chemical compositions comprising a dry form of glucose to form a plurality of different chemical component solutions comprising a glucose solution, Forming a dialysis fluid comprising a mixture of said chemical component solutions in a mixing module, Placing the mixing module in fluid communication with a dialysis dial line to allow the dialysis solution to flow from the mixing chamber into the dialysis line ≪ / RTI > CLAIMS What is claimed is: 1. A method for preparing a dialysis solution at a patient's treatment site, At the patient ' s treatment site, at least a portion of the dialysis solution components are provided in substantially dry form, At the treatment site of the patient, priming a substantially dry component of the dialysis solution to form a solution component of the dialysis solution, At least a portion of the solution components are mixed together to form a concentrated solution, Diluting the concentrated solution with a liquid to form a dialysis solution ≪ / RTI > A method for performing a dialysis treatment, Adding a liquid to a plurality of different chemical compositions to form chemical components for use in dialysis solution formation, At least a portion of the chemical component solution is mixed together in a mixing module to form a concentrated solution, Diluting the concentrated solution with a liquid in the mixing module to form a dialysis solution, Flowing the dialysis solution from the mixing module toward the patient ' s dialysis line Wherein the dialysis treatment is carried out by the dialysis treatment. As a system enabling the selective preparation of different formulations of dialysis solutions, A container comprising a plurality of compartments containing a chemical component in combination with a liquid to form a constituent component of the dialysis solution; Is coupled to the compartment and is fluidly connected to a liquid source to cause the liquid to flow toward the compartment So that the components of the dialysis solution can be formed in the compartment A plurality of flow paths, Wherein the dialysis solution component is in fluid communication with the flow path, To the mixing chamber, The dialysis solution components flowing from the compartment toward the mixing chamber At least one flow regulator At least one module comprising: A controller for controlling said at least one flow regulator to adjust the amount of said components flowing into said mixing chamber, / RTI > An apparatus for generating a dialysis fluid for introduction into a patient's abdominal cavity at a treatment site, A plurality of chambers respectively containing concentrates of the peritoneal dialysis fluid component, A fluid mixer configured to mix the concentrate with a liquid to produce a peritoneal dialysis fluid, A controller configured to control the fluid mixer to selectively generate a peritoneal dialysis fluid selected from the group of different formulations; A sterilizer configured to sterilize at least one of the peritoneal dialysis fluid and the liquid; And a patient inlet connection configured to fluidically transmit the peritoneal dialysis fluid to a patient ' s membrane cavity, Wherein the controller is provided with data input means for receiving predetermined prescription information for a patient and the controller is operable to control the fluid mixer based on the received predetermined prescription information to generate a peritoneal dialysis fluid preparation Device. The apparatus of claim 107, wherein the concentrate comprises a plurality of electrolytes, and wherein the controller is operable to selectively generate a peritoneal dialysis fluid formulation having different relative electrolyte concentrations from each other. 107. The apparatus of claim 107, wherein the chamber is in the form of a compartment of a vessel, wherein all of the concentrate required to produce the peritoneal dialysis preparation is provided in the compartment. An apparatus for generating a peritoneal dialysis fluid for introduction into a patient ' s abdominal cavity at a treatment site, A plurality of chambers respectively containing concentrates of the peritoneal dialysis fluid component, A fluid mixer configured to mix the concentrate with a liquid to produce a peritoneal dialysis fluid, A controller configured to control the fluid mixer to selectively generate a peritoneal dialysis fluid selected from a group of different formulations, A sterilizer configured to sterilize at least one of the liquid and the peritoneal dialysis fluid; And a patient inlet connection configured to fluidically transmit the peritoneal dialysis fluid to a patient ' s membrane cavity, Wherein the concentrate comprises a plurality of electrolytes and the controller is operable to selectively generate a peritoneal dialysis fluid preparation having different relative concentrations of electrolyte. The apparatus of claim 109, wherein the plurality of chambers are formed by a single vessel. The apparatus of claim 111, further comprising a container engagement portion for engaging the container and forcing the container to a position in which the chamber is open to communicate with respective portions of the device. 105. The apparatus of claim 112, wherein each chamber is provided with an opening forming means and a flange provided adjacent the opening, the container engaging portion being configured to engage the flange adjacent the opening. 113. The apparatus of claim 113, wherein the openings are linearly aligned with each other, and the container engagement comprises a pair of laterally spaced members disposed to engage the flanges formed on opposite sides of the opening. 118. The apparatus of claim 110, wherein the chamber is provided with a perforated seal to open the chamber, the apparatus further comprising a plurality of spikes to puncture each seal of the chamber to open the chamber. The apparatus of claim 115, wherein the spike includes two fluid flow channels. The apparatus of claim 115, wherein the spike includes a pair of spikes that puncture the osmotic agent containing chamber to provide at least three fluid flow channels. ≪ RTI ID = 0.0 > 115. < / RTI > The apparatus of claim 115, further comprising a lid covering the corresponding spike when the vessel is removed so that the spike can be disinfected. The apparatus of claim 118, further comprising a container engagement portion configured to engage the lid and force the lid to the covering position. The water treatment system according to claim 107, further comprising a water purifier, wherein the water purifier includes a first reverse osmosis membrane unit and a second reverse osmosis membrane unit, each membrane unit being provided with an inlet, a purified water outlet and a wastewater outlet, Wherein the purified water outlet of the second membrane unit is in fluid communication with the inlet of the second membrane unit and the wastewater outlet of the second membrane unit is in fluid communication with the inlet of the first membrane unit. The apparatus of claim 120, wherein the water purifier further comprises at least one of a coarse filter, a water softener, and a fine filter on the upstream side of the first reverse osmosis unit inlet. The apparatus of claim 120, wherein the water purifier further comprises a degassing arrangement on an upstream side of the first reverse osmosis membrane unit inlet. An apparatus for generating a peritoneal dialysis fluid at a treatment site, A water inlet configured to receive water exiting the water supply, A water purifier configured to purify water from the water inlet; A fluid mixer configured to mix a dialysis fluid concentrate with purified water to produce a peritoneal dialysis fluid, A sterilizer configured to sterilize the peritoneal dialysis fluid; And a patient inlet connection configured to fluidically transmit the sterilized peritoneal dialysis fluid feed to a patient ' s ' Wherein the sterilizer is a heat sterilizer configured to thermally sterilize the peritoneal dialysis fluid at a sterilization temperature and a high pressure. The apparatus of claim 123, wherein the thermosister is installed downstream of the fluid mixer. The apparatus of claim 123, wherein the heat sterilizer comprises a sterilizing flow passage and is configured to heat sterilize the fluid as the peritoneal dialysis fluid flows along the sterilizing flow passage. The system for sterilizing peritoneal dialysis fluid according to claim 125, further comprising: a flow path for allowing a sterilized peritoneal dialysis fluid downstream of the thermosistering device to flow to the patient-injecting connection part; and cooling the fluid as the sterilized peritoneal dialysis fluid flows along the flow path Lt; RTI ID = 0.0 > peritoneal dialysis fluid cooler. ≪ / RTI > The device of claim 126, wherein the device is configured to heat sterilize the flow path prior to use thereof such that the sterilized peritoneal dialysis fluid can flow into the patient inlet connection. The apparatus of claim 123, wherein the thermostatic device is configured to heat the peritoneal dialysis fluid to a temperature of at least about 140 ° C. The apparatus of claim 123, wherein the thermosister is arranged to heat the peritoneal dialysis fluid to obtain an F ₀ value of at least about 20 minutes, and F ₀ is given by: L: Length of the sterilization fluid path for the peritoneal dialysis fluid S: Internal cross-sectional area of the sterilization fluid path Q: volumetric flow rate of peritoneal dialysis fluid along the sterilization fluid path T (y) is the temperature distribution of the peritoneal dialysis fluid as a function of the distance from the starting point of the sterile fluid path. Connecting the patient dialysis tube to the connector on the dialysis treatment system, The dialysis solution flows along the flow path in the dialysis treatment system toward the patient dialysis tube, In the sterilization module in the system, the dialysis solution flowing into the patient dialyzer tube is sterilized, Sterilizing at least a substantial portion of the flow path in the dialysis treatment system, Wherein disinfection of the flow path comprises flowing a sterilizing fluid in a flow path between the sterilizing module and the connector. A dialysis system capable of producing a dialysis solution using tap water at a patient's treatment site, A water treatment module for treating and purifying tap water, A mixing module, connected to the water treatment module, for mixing the purified tap water with a plurality of chemical compositions to form a dialysis solution; A connector that is in flow connection with the mixing module and is configured to be connected to the patient dialysis line to allow the dialysis solution to flow from the system to the dialysis line . A system for forming a dialysis solution based on patient information, A processor for processing prescription information peculiar to a dialysis patient, A mixing module for mixing the components of the dialysis solution to form a dialysis solution, Wherein the mixing module controls the mixing module based on the prescription information so as to form a dialysis solution having a sufficient amount of constituent components in the patient, / RTI > The system of claim 132, further comprising a memory mechanism for storing the prescription information. The system of claim 133, wherein the memory mechanism is a portable mechanism, and the system further comprises a reader for reading the prescription information from the memory mechanism. A peritoneal dialysis treatment method using a dialysis solution prepared at a treatment site of a patient according to a predetermined formulation, Providing a processor configured to form a dialysis solution from a dialysis solution component at a patient ' s treatment site, Causing a vessel containing a dialysis solution component in an amount sufficient to form one of a plurality of different dialysis solution formulations to engage the processor, Processing information on a predetermined patient prescription in the processor, Forming a predetermined dialysis solution preparation in the processor according to the patient prescription, Placing the device in fluid communication with the peritoneal membrane of the patient, Flowing the dialysis solution into the multiple membrane cavity, The dialysis solution was removed from the multiple membrane steel, Removing the container from the processor 0.0 > peritoneal dialysis < / RTI > treatment method. The system of claim 135, further comprising inputting prescription information, the input including at least one of reading information from a smart card, receiving information via a modem, manually entering information on a user interface / RTI > wherein the peritoneal dialysis treatment comprises administering a therapeutically effective amount of a compound of formula The peritoneal dialysis treatment of claim 136, wherein the input of the information comprises inputting a desired osmotic concentration, wherein forming the predetermined formulation comprises preparing a dialysis solution having approximately the desired osmolality concentration Way. The method of claim 135, wherein forming the predetermined dialysis solution formulation further comprises: adding a liquid to a different chemical composition; processing information on a predetermined patient prescription in the processor; Comprising: forming a defined dialysis solution formulation; placing the device in fluid communication with the peritoneal fluid of the patient; flowing the dialysis solution into the multiple membrane cavity; removing the dialysis solution from the multiple membrane steel; Lt; RTI ID = 0.0 > peritoneal dialysis < / RTI > treatment method. The method of claim 135, wherein forming the predetermined dialysis solution formulation comprises adding a liquid to a different chemical composition to form a different chemical component solution, and admixing a chemical component solution of this amount . 144. The method of claim 139, wherein at least some of the chemical compositions are in substantially dry form. Tap water inlet, At least one particle filter in flow communication with the tap inlet, And a degassing chamber configured to remove gas from the molten material Gas portion, A first reverse osmosis membrane having a first inlet, a first purified water outlet and a first outlet, unit, The second reverse osmosis membrane having a second inlet, a second purified water outlet, and a second outlet Unit, Wherein the first purified water outlet is in flow communication with the second inlet, The second wastewater outlet is in fluid communication with the first inlet A water purification module; A heat control and sterilization module including a plurality of heat exchangers in flow communication with the water purification module and configured to transfer heat between the liquid flowing in the dialysis system; A concentrate mixing module in flow communication with the water preparation module and the thermal control and sterilization module, A flow channel is provided, at least some of which contains a concentrated dialysis solution component, And a plurality of fluid reservoirs The plug, And is configured to adjust the flow of liquid, At least one of a liquid flow through the compartment and a liquid flow from the compartment A plurality of valves, A concentrate reservoir in flow communication with the flow coupler, At least one of which is configured to detect the conductivity of the liquid flowing into the concentrate reservoir My conductivity sensor, The concentrated water storage portion, and the purified water output portion of the water purification module, A mixing chamber for forming a solution, At least at least one of the flow coupler, the concentrate storage, My pump A concentrate mixing module; The effluent draining section and A connector configured to be connected to the patient dialysis line and in flow communication with the mixing chamber to allow the dialysis solution to flow towards the patient dialysis line; . The dialysis system of claim 141, wherein the flow coupler comprises a spike adapted to extend into a port on the vessel. The dialysis system of claim 141, wherein the thermal control and sterilization module is configured to heat a dialysis fluid flowing from the mixing chamber to a connector to sterilize the dialysis fluid.