JP2002539896A - Method, apparatus and components of dialysis system - Google Patents

Abstract

An apparatus for dispensing peritoneal dialysis fluid includes a water preparation module for purifying raw water and supplying the purified water to a heat control and sterilization module. The thermal control and sterilization module 300 sends purified water to a concentrate mixing module 400, which mixes the purified water with the concentrated components of the dialysis fluid from the disposable concentrate container 402 to prepare a peritoneal dialysis fluid. I do. At least some of the concentrated components of the dialysis fluid are in powder form. The peritoneal dialysis fluid is returned from the concentrate mixing module 400 to the thermal control and sterilization module 300, where the peritoneal dialysis fluid is on-line before being sent to the cycler and sterilization connector module 600 to administer the patient 50. Sterilized inside the autoclave. The device has the advantage that the peritoneal dialysis fluid can be prepared online at a treatment site, such as the patient's bedroom, based on the patient's unique prescription.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001] This application is based on Swedish Patent Application No. 9901165-2, filed Mar. 30, 1999, the entire disclosure of which is incorporated herein by reference. US Provisional Patent Application No. 60 / 127,179, filed March 30, 1999, is also incorporated herein by reference.

FIELD OF THE INVENTION [0002] The present invention relates to methods, apparatus and components for dialysis systems such as peritoneal dialysis systems, hemodialysis systems, hemodiafiltration systems or hemofiltration systems.

BACKGROUND OF THE INVENTION Kidney dysfunction is a serious, life-threatening illness that causes mammalian kidneys to remove impurities, remove excess water, and perform other physiologically important functions. Will not be able to carry out. Individuals with renal insufficiency need to undergo regular dialysis treatment for blood purification and water removal.

Conventionally, in peritoneal dialysis (PD), which is a form of dialysis treatment, a PD fluid is administered to the peritoneal cavity of a patient who is a mammal, and is retained in the peritoneal cavity. Was. Waste products are transferred to the PD fluid and removed with the waste dialysate. The permeant in the PD fluid removes excess water. Buffer in PD fluid (buffe)
r) replenishes body buffer. Other electrolytes are balanced by the PD fluid.

[0005] PD fluids pass through the body of the patient and are therefore at risk of infection causing peritonitis.

When performing peritoneal dialysis, a coupling is used to connect a catheter terminated in the peritoneal cavity to a PD fluid source. In one attempt to reduce patient infection, such couplings are made into "sterile" or "bactericidal" couplings. Among them, aseptic coupling reduces the contamination of PD fluids,
Each coupling can cause potentially harmful microorganisms such as bacteria and fungi to invade other bactericidal PD systems and consequently migrate into the peritoneal cavity. Reducing the number of these couplings can reduce the risk of infection and peritonitis.

[0007] Usually, the germicidal PD fluid is stored in a plastic fluid bag from which the patient is dispensed. Generally, the fluid bladder is connected to the patient's catheter via a sterile coupling. Each coupling increases the potential for contamination by bacteria and the like.

[0008] The two most common forms of PD, continuous ambulatory peritoneal dialysis (CAPD) and automatic peritoneal dialysis (APD), require many fluid bags to be used on a yearly basis. CAPD typically relies on gravity to fill and drain the PD fluid in the bag set, allowing continuous treatment with relatively free movement of the patient. Fluid exchange usually takes place during the day. Since APD relies on a cycler to pump PD fluid from a fluid bag to perform a fill and drain cycle for a patient, such operations are performed primarily during the night when the patient is sleeping. In both cases, the specially formulated PD fluid is manufactured at a manufacturing plant under a sterile atmosphere and packaged in one or more bags, which are then transported to a patient or physician.

However, the use of PD fluid bags has many disadvantages and deficiencies. Since dialysis conditions vary from patient to patient, and these conditions can change over time, the benefit of the use of PD fluids must be substantially met to meet the needs of the patient. . Consequently, PD fluid manufacturers must produce and deliver many preparations of different PD fluids. This creates a different P in the patient's house
Frequently, it is necessary to store a large number of bags to receive a preparation of D-fluid.

[0010] Recently, clinical trials have been conducted using bicarbonate instead of the usual PD fluid salt buffered with lactic acid as a buffer. Normal PD fluids have a relatively low pH, which makes the filling process inconvenient and can cause pain. The use of bicarbonate as a buffer also allows the preparation of PD fluids with physiological pH. However, over time, calcium carbonate from various components of the PD fluid may
It may precipitate in a solution of the fluid, rendering it unusable.

Glucose, another component of the PD fluid, can degrade over time, especially if the PD fluid is normally heat sterilized in an autoclave.
Degradation of glucose can create degradation products that are potentially harmful to the patient, at least over an extended period of time.

[0012] PD fluid bags are often transported over very long distances from the manufacturer to the point of use. Because the majority of the PD fluid is made up of water, a large amount of water is effectively transported from the PD fluid manufacturing plant to a treatment point, such as a hospital, clinic or patient home.

Also, the size of the PD fluid bag is limited because it must be light enough to be easily handled by patients and doctors. Most PD fluid bags used for CAPD receive relatively small volumes of fluid, for example, 0.5-5 liters. If a large volume is required, such as APD, multiple PD fluid bags may be used during each treatment period. However, if at least one PD fluid bag is used, a sterile coupling for each bag is required, and a relatively complicated connection and disconnection process is required when changing the bags. Such additional coupling and decoupling processes are performed under aseptic conditions, but offer the potential for potentially harmful bacteria to enter the dialysis system and cause peritonitis. APDs may use four or five coupling devices.

During dialysis, particularly when dialysis of sensitive blood, a bag of sterile dialysis solution is used. During hemofiltration and hemodiafiltration, an infusion solution is used for infusion into the blood. Such solutions have the same problems as described above.

US Pat. No. 4,718,890; US Pat. No. 4,747,822; US Pat. No. 5,004,459; US Pat.
It has been proposed to prepare and administer D fluid. However, these methods have various problems and disadvantages. As an example, US Pat. No. 5,643,201 discloses a system for preparing a PD fluid using a concentrated dialysis liquid source as a starting point. In this system, water is purified by a reverse osmosis unit and then mixed with a liquid concentrate by a positive displacement pump. Further, a glucose solution can be added by a glucose pump. The fluid mixture is heated to a temperature of 70 ° C. to 80 ° C., then cooled to a temperature suitable for administration to a patient, and passed through a weighable storage container for volumetric examination to determine the peritoneal cavity of the patient. Sent to Since such systems use concentrated solutions as PD fluid concentrates, problems can occur with the stability of the concentrates, for example, when using bicarbonate buffers. Also the proposed 70 ° C
Temperatures of ８０80 ° C. may be inappropriate for sterilization to sufficiently high levels.

[0016] Further, as an optional matter, glucose may be added as an additional matter.
The relative concentrations of the electrolyte components of the solution are fixed by their relative concentrations in their initially concentrated form. Therefore, apart from the glucose concentration, PD
The basic formula of the fluid is predetermined by the ratio of the constituents of the concentrated initial dialysis liquid source. Where it is possible to use the system for other formulations, a predetermined range of different concentrated dialysis liquid sources, each containing components present in appropriate proportions for that formulation, is provided. Must be provided. Therefore,
When a predetermined source, such as a bag of concentrated dialysis liquid, is required, the PD fluid must be completely pre-prepared at a remote manufacturing location, creating logistical problems similar to PD processing systems. I do.

[0017] Another proposal for producing a medical aqueous solution containing a PD fluid is GB145030.
Is disclosed. This again uses a concentrated solution as a starting point. The relative concentration of the electrolyte is predetermined by the concentrated starting solution. Since 1972, this proposal has not provided any details on how to deliver PD fluid to the patient.

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

SUMMARY OF THE INVENTION Accordingly, the present invention discloses an apparatus and method that can substantially obviate at least one of the disadvantages or shortcomings of the related art described above.

It is an object of the present invention to prepare a medical fluid by substantially mixing water and at least one concentrate at a patient's treatment site. This fluid can be prepared from ordinary raw water. As a result, the patient's treatment conditions can be met by a compacted concentrate package as opposed to a plurality of fluid bags. This is convenient for the patient and the attending physician. This not only saves storage and shipping costs by reducing weight and volume, but also improves logistics management. The use of less disposable elements, including the use of less plastic, can provide significant environmental benefits.

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

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

It is another object of the present invention to provide a container that receives at least one concentrate with a cleaning agent. In this manner, the therapeutic agent and the cleaning agent can be conveniently packaged.

Yet another object of the present invention is to provide a medical treatment device with a reduced number of sterile connections. No or only one sterile link is present. This reduces the risk of infection such as peritonitis.

Another object of the present invention is to provide an electronic communication system with a dialysis machine in which patient prescriptions are made via a smart card. In this manner, if the patient's prescription changes, the dialysis machine can be further programmed while continuing to use the same universal cartridge.

It is yet another object of the present invention to provide more fluid dosages during peritoneal dialysis treatment without significant additional cost, unlike conventional peritoneal dialysis systems where cost is approximately proportional to fluid volume. It is to provide a system that can do it. The larger volume of fluid means that patients who convert from conventional PD to other treatment modalities, such as hemodialysis (HD), in the PD state for extended periods of time because conventional PD provides inadequate treatment. It means that you can let it be maintained across.

[0027] It is another object of the present invention to provide a system that sterilizes peritoneal dialysis fluid immediately prior to dispensing to a patient to minimize the possibility of bacteria entering the peritoneum.

It is understood that the present invention can be practiced without performing at least one of the above-described objects and / or advantages, or with performing such objects and / or advantages incompletely. Must. Other objects and advantages of the present invention will become apparent through the following detailed description of the invention and the appended claims.

To achieve the foregoing and other objects and advantages, the present invention includes many aspects, as embodied and generically described herein based on the objects of the present invention.

According to a first aspect, the present invention provides an apparatus for producing a peritoneal dialysis fluid for introduction into a patient's peritoneal cavity at a point of treatment, the apparatus comprising: A plurality of chambers each containing a concentrate; a fluid mixer arranged to mix the concentrate with a liquid to produce a peritoneal dialysis fluid; and sterilizing at least one of the liquid and the peritoneal dialysis fluid. And a patient filling connection arranged so that the peritoneal dialysis fluid is in fluid communication with the peritoneal cavity of the patient, at least one of the concentrates being substantially dry. Characterized in that it is at least partially dissolved during use of said measure to form part of the peritoneal dialysis fluid.

The present invention also provides a method of forming a peritoneal dialysis fluid at a point of treatment and introducing the fluid into the peritoneal cavity of a patient, the method comprising the steps of: Mixing the concentrate with a liquid to obtain a peritoneal dialysis fluid, sterilizing at least one of the liquid and the peritoneal dialysis fluid, and introducing the peritoneal dialysis fluid into a patient's peritoneal cavity; At least one of the concentrates is characterized in that it is at least partially dissolved in a substantially dry form to form part of the peritoneal dialysis fluid.

By providing the concentrate in a substantially dry or solid form, eg, a powder, problems associated with liquid concentrates, such as settling, shelf life, etc., can be minimized.

[0033] At least one of the concentrates is a carbohydrate, gluconate.
e), peptides, ketoacids, glycerol, glucose polymers, disaccharids
e) and the like. In one embodiment, the osmotic agent is glucose or glucose. When glucose is provided as a solution, it generally has a limited shelf life before use. Providing a substantially dry or solid form of the permeant and dissolving it at the point of use may also increase its shelf life.

At least one of the concentrates is a buffer such as bicarbonate, lactate, acetate, pyruvate, hydroxy-butyrate, phosphate and the like. It is. In one embodiment, sodium bicarbonate or sodium lactate, or a combination thereof, is used as a buffer. By providing the sodium bicarbonate in a substantially dry or solid form, the problem of solution degradation due to solid precipitation can be prevented. Sodium bicarbonate is always preferred as a buffer for physiological reasons, but other buffers may be used during peritoneal dialysis. Therefore, it is advantageous to use substantially solid sodium bicarbonate in a peritoneal dialysis treatment system that later dissolves in solution at the point of treatment.

The concentrate provided in a particular chamber may include at least one substance, for example, some or all of the electrolyte may be provided in one chamber, and the other chamber may be a permeant. Can also be provided. In one embodiment, each concentrate comprises another component of the peritoneal dialysis fluid. Each chamber for producing peritoneal dialysis fluid contains sodium chloride, sodium bicarbonate, magnesium chloride,
It may contain another component of the peritoneal dialysis fluid selected from the group consisting of calcium chloride, sodium lactate, lactic acid and glucose.

[0036] At least one of the concentrates can be provided in a liquid form, and can also be provided in a substantially dry form. In one embodiment, the concentrate is 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 lactic acid solution, Contains dry form of glucose.

According to a first aspect of the present invention, by providing a plurality of concentrates of peritoneal dialysis fluid components in each chamber, it is possible to produce peritoneal dialysis fluids of different preparations. become. Said measures include a controller for controlling the fluid mixer mixer to prepare such different preparations. Thus, preparations can be selected that can be manufactured using multiple concentrates and liquids, such as purified water. For example, using a single disposable container to receive the concentrate,
The different preparations required can be produced depending on the patient's prescription. This is more convenient than currently available systems that provide peritoneal dialysis fluid to patients,
In such current systems, the manufacturer must stock up a range of fluid bags of different preparations, supply bags for treatment of the user, and the user must select the bag. Must. Alternatively, the user can always be supplied with several identical concentrates, which are used in equipment for producing the required preparation.

In one embodiment, the concentrate comprises a plurality of electrolytes, and the controller is operable to produce a peritoneal dialysis fluid preparation having different relative concentrations of electrolytes. Thus, instead of simply changing the concentration of the osmotic agent (eg, glucose), the measure can change the relative concentration of the electrolyte in the peritoneal dialysis fluid depending on the patient's prescription. This is an improvement over conventional systems that produce peritoneal dialysis fluid at the point of treatment using a combined single electrolyte source. The electrolyte used in the peritoneal dialysis fluid is at least one 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 about the patient. Such data input means may include a keyboard or a touch screen that allows a person to enter required prescription information. In one embodiment, the data entry means comprises a memory device such as a smart card that can be inserted into an appropriate part of the measure. Alternatively or additionally, the data input means may include, for example, a modem for monitoring the device or transmitting prescription information to the device or other means capable of remote communication.

The substantially dry or solid concentrate can be dissolved in the chamber in which the concentrate is supplied. Because some concentrates require relatively large volumes of solution, the chamber is not bulky and is generally not large enough to accept enough water to dissolve all concentrates . Examples of such concentrates in peritoneal dialysis solutions include sodium chloride and sodium bicarbonate. In such a case, more than a single chamber volume of water is used to dissolve the concentrate. One way to accomplish this is to fill the chamber with water through holes and then use an air vent to allow air to enter and fill the chamber when emptying the chamber. (If the walls of the chamber are relatively rigid, no air vent is needed for a chamber with flexible walls.) Empty the chamber by backflow through the same hole. The filling can then be performed further, and such a process is repeated multiple times as needed.

In another arrangement, the measure is arranged to inject a liquid comprising water into the at least one concentrate in substantially dry form in each chamber, wherein the amount of concentrate in the chamber and the amount of the concentrate in the chamber are different. The size of is set to an amount and size such that the concentrate is only partially dissolved when the chamber is filled with liquid, said measure removing liquid containing dissolved concentrate from the chamber. And a flow tube for adding the same amount of liquid removed to the chamber substantially simultaneously.

With this arrangement, the number of cycles and inaccuracies required for a given peritoneal dialysis fluid configuration after an initial continuous flow instead of a periodic flow is injected into the fluid mixer. Possibility can be reduced. Thus, two flow tubes are provided for simultaneous use. One of these can be conveniently used for injection and the other can be used to evacuate air from the container, but in the case of a hard-walled chamber an air vent is used. is necessary. The concentrate removal flow tube can be used during pre-treatment to introduce liquid containing water into the chamber, and the liquid addition flow tube is used during pre-treatment to evacuate air from the chamber. No exhaust is required for normal use.

Such a first form of chamber or partial lysis chamber is suitable for receiving sodium chloride or sodium bicarbonate for producing a peritoneal dialysis fluid.

The second form of the chamber is designed for other components of the peritoneal dialysis fluid, such as calcium chloride and magnesium chloride. For such a concentrate,
The concentrate is generally required in peritoneal dialysis fluids only in relatively small amounts and low concentrations, so that a relatively small chamber has a volume suitable for dissolving a sufficient amount of concentrate to fill some liquid. Can be. Accordingly, the measures can also be arranged to pre-treat the liquid comprising water in at least one concentrate in substantially dry form in each chamber, wherein the amount of concentrate in the chamber and the amount of Is the amount and size at which the concentrate is sufficiently dissolved when the chamber is filled with liquid. By configuring the chamber in this manner, the inflow tube for pretreatment can conveniently use a flow tube similar to that used to remove dissolved concentrate from the chamber. In the case of a hard-walled chamber, an air vent may be provided to evacuate air during pre-treatment and emptying.

The third form of the chamber can be used for a permeant, usually glucose. The penetrant is provided in a substantially dry or solid, eg, powdered form, and the measures are suitably provided to agitate and rock or recirculate the glucose once the liquid containing water is added. This is because it is relatively difficult to rapidly dissolve glucose. In one embodiment of the device, each chamber contains a permeant, such as glucose, wherein the steps introduce a liquid containing water into the permeant chamber and remove the liquid containing dissolved permeate from the chamber. Includes a flow circuit that removes and reintroduces the liquid containing dissolved permeant into the chamber. For example,
Glucose dissolution is generally facilitated by heating the diluting liquid to, for example, 40 ° C. The heated liquid can be initially supplied to the glucose chamber. It is preferable to maintain the heated glucose during dissolution and circulation, and it is therefore advantageous to provide a heater for heating the liquid containing dissolved glucose by circulating the liquid around the flow circuit. .

Since glucose powder tends to release bubbles during dissolution, such measures include vents that allow the liquid containing the dissolved glucose to evacuate by circulating around the flow circuit. It can be provided.

A plurality of chambers containing each concentrate can be provided by at least one container. However, it is convenient for the user if all additives for producing the peritoneal dialysis fluid are provided in a single container. In one embodiment, the plurality of chambers are defined as disposable containers. In other embodiments,
Each chamber is in the form of a compartment of a container.

Therefore, in order to match different requirements for different components of the peritoneal dialysis fluid, ie, taking into account the amount of each component normally required and the difficulty of dissolving each component, the different types It can be seen that multiple chambers can be provided. However, from the user's point of view, it is advantageous to provide all the chambers and the components of the peritoneal dialysis fluid that they receive in a single container. This can provide all the components required during nighttime peritoneal dialysis treatment, eliminating the need for the user to set up the multiple fluid bags required for conventional peritoneal dialysis treatments, for example, 8-10 liters of peritoneal dialysis. Dialysis fluid can be used.

The container can be supported in a fixed position on the device, and the device can be provided with a chamber communication part, eg a spike, which moves to a position communicating with the interior of the chamber.
In one embodiment, the measure includes a container engaging 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.

In general, it is preferable to arrange the container at a position where the container engages with the container engaging portion. One way to accomplish this is for the user to slide the container in a first direction, e.g., horizontally, to an engaged position, and then the container engaging portion moves the container in a second direction, e.g., vertically, to a communicating position. Force.

The container engaging part can, for example, mesh with a container area remote from the chamber area where the chamber is opened. This is the base of the container, which can be turned over so that its open area faces downwards. In one embodiment, the container engaging portion is arranged to mate with a plurality of flanges provided near each hole in each chamber. By engaging in the vicinity of the hole, a reliable forcing in the hole area of the container can be achieved. The flange is formed, for example, at the neck forming the hole of each chamber.

In one embodiment, the flange associated with each hole reliably and reliably ensures that each hole meshes with the chamber communication of the device. It can be seen that it is important that all intended communication paths are formed at the interface between the device and the container. In one exemplary container, there are eight chamber holes that are in communication. One embodiment of an arrangement for achieving the desired reliable interface is such that at least two container holes are linearly arranged with respect to each other, and each container engagement portion engages a flange formed on the opposite side of the hole. Including a pair of laterally spaced members arranged.

In one embodiment of the above measure, a plurality of spikes are provided to open the chamber through each seal of the chamber. Each spike allows a liquid or gas to enter and exit the chamber at the same time2
Advantageously, two fluid flow channels are provided. As will be apparent from the description below, in the case of a chamber receiving glucose, it is advantageous to provide three flow channels, while two channels are provided for other concentrates. . Rather than providing three flow channel spikes, a pair of spikes is provided that penetrate a chamber that receives a permeant, eg, glucose. This can provide three flow channels, of which two
One is from one spike and the third is from another spike. Also, because the permeant chamber is typically substantially larger than the other chambers, there is sufficient space in the wall of the permeant chamber to provide two holes.

After using the container to supply at least one peritoneal dialysis patient filling additive, the container is removed and a new container is used during the next treatment period. It is advantageous to disinfect the spikes during treatment. The measures include a cover over the spike when the container is removed so that the spike can be disinfected. The container engagement may be arranged to engage the lid and force the lid into its covering position. Therefore,
The container engaging portion can perform the function of forcing the container to its communicating position and the function of forcing the lid to its covering position if there is no container.

It will be appreciated that the containers disclosed herein embody a number of advanced aspects. Accordingly, a second aspect of the present invention relates to a container as a disposable container.

In one form of the second aspect, the present invention provides a container receiving all the concentrate in concentrated form, wherein the concentrate, when mixed with water, throughout the duration of the peritoneal dialysis treatment Provide sufficient peritoneal dialysis fluid.

In another form of the second aspect, the invention provides a container for receiving a concentrated component of the dialysis fluid, the container comprising a chamber for receiving glucose to be powdered, and at least one chamber. At least one other chamber receiving two powdered inorganic salts.

In yet another form of the second aspect, the invention provides a container for receiving a concentrated component of the dialysis fluid, the container comprising at least one chamber for receiving a cleaning agent, at least one chamber for receiving a detergent. And at least one other chamber for receiving one powdered inorganic salt. Advantageously, the detergent is provided in the same container as at least one concentrate for producing a peritoneal dialysis fluid, which is a concentrated PD instead of an individual container which may be mistaken by the user. The operation of the above measures is convenient, since only one container needs to be inserted into the device to provide the fluid and the cleaning agent.

In another form of the second aspect, the invention provides a container receiving the concentrated component of the dialysis fluid, wherein the container defines at least two distinct chambers therein, each chamber comprising: Accepts different inorganic salts, and the volume of each chamber and the amount of salt received in each chamber can be adjusted if each salt solution is prepared by filling each chamber with a liquid such as water. , The volumes and amounts that characteristically alter the conductivity of the solution so prepared. As will be described in more detail below, such an arrangement utilizes the above measures to use containers to check whether each container is receiving the correct concentrate or inorganic salt from each chamber. Be able to do it.

In another form of the second aspect, the invention provides a container for receiving a concentrated component of the dialysis fluid, the container forming a plurality of individual chambers therein, wherein the container comprises a plurality of individual chambers. It includes at least one connector coupled to the chamber, each connector including at least two separate fluid channels to allow simultaneous inflow and outflow into and out of each chamber. Such an arrangement allows gas to exit the chamber through another fluid channel by liquid entering through the fluid channel and / or allows gas to exit the chamber through the other fluid channel by exiting the liquid through the fluid channel. And / or allow alternative liquid to flow into the chamber as the liquid exits the chamber. Such an arrangement is particularly useful where the chamber has relatively rigid walls instead of flexible (ie, easily collapsed) walls, where the walls of the chamber are empty or filled. Remains substantially constant, regardless of whether Unlike providing a vent at any point on the chamber, by providing at least two fluid channels as part of the connector, the two fluid channels can be, for example, by breaking a seal in membrane or diaphragm form. It can be opened and restricted only when the containers are used simultaneously.

[0061] In one configuration, at least two fluid channels are arranged concentrically at each connector. Such a form of connector can be coupled to a spike, for example, as described above, provided with two fluid channels per se.

In the case of a chamber receiving a permeant, for example glucose, it is useful to provide two or more, especially three, fluid channels. In one embodiment, at least one of the chambers includes two connectors, such connectors include at least two separate flow channels, and other connectors include additional fluid channels.

Also, in the case of a permeating agent such as glucose, its dissolution can be facilitated by providing a diffuser, preferably in at least one fluid channel, to diffuse the liquid inflow into the chamber.

In one embodiment, the connector is provided in operation in a lower region of the chamber, and one of the fluid channels of at least one connector has a portion extending to the upper region of the chamber. This part of the upper region can be used, for example, as an air vent or as an inlet for alternative fluids or for recirculation.

As described above, at least some of the holes in the chamber are aligned with one another. The holes are aligned with one another along a linear axis. Thus, all of the connectors can be engaged by the container engagement of the device. The connector may include a neck with an outer flange formed for engagement by the container engagement. A pair of flanges can be provided on both sides of the neck, or one flange can extend circumferentially around the neck. Next, the container engaging portion is in the form of a pair of members (forks) separated in the side direction that engages with the flange.

The container must be uniquely mounted on and insertable into the dialysis machine in order to ensure that the correct connector is aligned with the required communication of the device. In one embodiment, the linear axes of the connectors aligned with one another are deflected from the central axis of the container. Secondly, the container can only interface with the device in a precise manner.

In another form of the second aspect of the present invention, there is provided a container for use in pretreating powdered glucose at a point of treatment of a patient, wherein the powdered glucose is dissolved in the container. An inlet in the lower region of the vessel for receiving the feed water to be made, the inlet being provided with a diffuser arranged to diffuse the water stream into powdered glucose.

In another form 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 individual chambers are formed within the container, the container being associated with each chamber. It includes at least one connector, at least two of the connectors being aligned with one another along a linear axis.

In another form 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 individual chambers are formed within the container, the container comprising a container body and each chamber. And at least one axis wherein the container body is substantially rotationally symmetric about the axis, wherein the connectors are arranged relative to the container body to be rotationally asymmetric about the axis. Have been.

During manufacture of the container, each chamber can be charged with a suitable concentrate. Successive loading of each chamber of a single container can be problematic. Thus, the container can be manufactured as a plurality of auxiliary containers which are later joined together.

In another form of the second aspect of the present invention, the present invention provides a method of manufacturing a container for a concentrated component of a dialysis fluid, the method comprising the steps of manufacturing a plurality of individual auxiliary containers; Connecting the auxiliary container to form a container.

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

The measures can be connected to a source of purified water, for example a reverse osmosis unit. In one embodiment, the measure comprises a water purifier. The water purifier includes, for example, at least one reverse osmosis unit. In one embodiment, the water purifier includes a first reverse osmosis unit and a second reverse osmosis unit. Each permeable membrane unit has an inlet, a purified water outlet, and a wastewater outlet. In one embodiment, the purified water outlet of the first permeable membrane unit is in fluid communication with the inlet of the second permeable membrane unit. Further, the wastewater outlet of the second permeable membrane unit can be in fluid communication with the inlet of the second permeable membrane unit.

According to the above configuration, since the water is discharged from the wastewater outlet of the second permeable membrane unit and passes through the first permeable membrane unit, rationally pure water is regenerated and the first permeable membrane unit is further processed. The total water consumption of the measures passed will decrease. In a similar manner, two permeable membrane units can be used to provide high purity water without increasing the overall water consumption of the measure.

The water purifier is provided, for example, with a filter (for example, 30) upstream of the inlet of the permeable membrane unit.
Micron filter), fine filter (for example, 5 micron filter),
A charcoal filter and / or water softener may be included. Each of these components prevents the reverse osmosis membrane from becoming occluded.

The water purifier may further include a degassing configuration upstream of the first (or second) permeable membrane unit. The water is degassed before passing through the permeable membrane unit, reducing the amount of carbon dioxide and other gases dissolved in the water and improving the performance of the permeable membrane. Also, bubbles present in the water can interfere with the correct operation of the pump and the like. In general, it is desirable to degas the water early in the production of the peritoneal dialysis fluid, but this simplifies additional processing steps because the gas content dissolved in the water is fixed.

[0077] In one embodiment, the sterilizer is a heat sterilizer.

According to a third aspect, the present invention provides an apparatus for producing peritoneal dialysis fluid at a point of treatment, the apparatus comprising: an inlet for receiving feed water from a primary water source; A water purifier for purifying the supply water, a fluid mixer for supplying the peritoneal dialysis supply fluid by mixing the purified supply water and the peritoneal fluid concentrate, a sterilizer for sterilizing the peritoneal dialysis supply fluid, and a sterilized peritoneum A fluid outlet arranged to communicate the dialysis supply fluid to the peritoneal cavity of the patient, wherein the sterilizer is a heat sterilizer arranged to heat sterilize the peritoneal dialysis fluid at sterilization temperature and pressure. Features.

Heat sterilization is generally considered more effective and safer than, for example, bacterial filtration.

In one embodiment, a sterilizer is provided downstream of the fluid mixer to neutralize bacteria introduced into the peritoneal dialysis fluid during mixing. This eliminates the need for pre-sterilization of the concentrated component, thereby reducing the manufacturing cost of the concentrated component container.

The sterilizer can be arranged to sterilize the peritoneal dialysis fluid itself, but alternatively, the liquid used to form the peritoneal dialysis fluid and / or concentrate, such as water, At least one sterilizer can be provided for sterilizing at least one peritoneal dialysis fluid component. If the concentrate is provided as a bactericidal concentrate, only the water used to form the peritoneal dialysis fluid will be sterilized.

[0082] The sterilizer may also include a sterile flow path, wherein the peritoneal dialysis fluid is arranged to heat sterilize the fluid by flowing along the sterile flow path, wherein the flow of peritoneal dialysis fluid is heat sterilized. There is no need to stop it. In one embodiment, the measures include downstream of the heat sterilizer, a flow path for allowing sterilized peritoneal dialysis fluid to flow to the patient filling connection, and a flow path for sterilized peritoneal dialysis fluid along the flow path. Cooling means for cooling the fluid by flowing such that the temperature of the peritoneal dialysis fluid reaches body temperature when it reaches the patient filling connection. The measure may include a flow path that allows sterile peritoneal dialysis fluid to flow to the patient filling connection to ensure that the sterile fluid travels along the sterile flow path prior to use of the measure. It can be arranged to be heat sterilized.

[0083] A fourth aspect of the present invention is directed to a system for dissolving a substantially dry concentrate and transporting the dissolved concentrate to a mixing vessel.

Thus, according to a fourth aspect, the present invention provides an apparatus for producing a medical aqueous solution from a plurality of concentrates, the apparatus communicating with a plurality of chambers receiving each concentrate. Wherein at least one of the concentrates is in a substantially dry form, the apparatus comprising: pretreating at least one concentrate in a substantially dry form with a liquid comprising water to form at least one concentrate; At least one flow tube arranged to form two dissolved concentrates; a mixing vessel arranged to receive at least one dissolved concentrate; and at least one dissolved concentrate. A measuring means coupled to and comprising a flow conditioner arranged to pass the concentrate through the mixing vessel, the measuring means being arranged to measure the concentration of at least one dissolved concentrate; While measuring the concentration of the dissolved concentrate according to, the metered volume of at least one dissolved concentrate is pumped through a combined flow regulator to a mixing vessel to mix a predetermined amount of the dissolved concentrate. And a pump for urgently sending the container.

The invention also provides a method of providing a medical aqueous solution from a plurality of concentrates, the method comprising: providing at least one of the concentrates in a substantially dry form. In a separate chamber, pretreating at least one concentrate in a substantially dry form with a liquid comprising water to form at least one dissolved concentrate, and forming at least one dissolved concentrate. Adjusting the flow regulator associated with the at least one dissolved concentrate to flow the metered volume of the concentrate, comprising passing the concentrate through a flow regulator coupled to the concentrate; Determining the amount of concentrate to be sent to the mixing vessel by measuring the concentration of the concentrate through the machine and terminating the dispatch of the concentrate once the predetermined amount of concentrate has been dispatched. Characterized by You.

Thus, from the starting point of the concentrate, at least one concentrate is substantially dry, for example in the form of a powder, and contains a predetermined amount of each concentrate, whereby each concentrate has a predetermined concentration ratio An aqueous solution can also be obtained in a mixing vessel existing in the above. Such a solution can also be prepared exactly to the desired preparation and used for medical purposes, for example for peritoneal dialysis, hemodialysis, hemofiltration or hemodiafiltration purposes.

In general, it is intended to obtain a concentrate stream of a given concentration, which requires time, for example to achieve lysis, or adjusts, eg, dilution, to achieve a given concentration of the stream Deployment can take some time to deploy. It is advantageous to use the stream as soon as the desired concentration has been set, rather than draining the stream at the desired concentration while waiting for similar settings to be made for the other concentrates. By providing a mixing vessel in which a known amount of concentrate is stored, the concentrate can be immediately passed through the mixing vessel without delay and thus without significant loss to the discharge channel.

When a plurality of concentrates are provided in a substantially dry form, each such concentrate is pre-treated to form a dissolved concentrate and the concentration of the dissolved concentrate is determined. A metered volume of the dissolved concentrate is pumped into the mixing vessel via its associated valve, and a predetermined amount of the dissolved concentrate can be expedited to the mixing vessel. Thus, an aqueous solution containing a predetermined amount of each concentrate is obtained.

If the one or more concentrates are initially provided in liquid form, the concentrates can be provided at known concentrations, but in such cases, a concentration measurement step may not be necessary. It is sufficient to pump the metered volume into the mixing vessel. However, to ensure that the correct amount of all the concentrate is obtained in the mixing vessel, the concentration of the concentrate in the initial liquid form can be measured by passing the concentrate through the mixing vessel. This is also useful when the concentrate is initially provided in liquid form at an approximate concentration. One example of a concentrate that can be provided in liquid form, for example, to produce a peritoneal dialysis fluid, is lactic acid.

Accordingly, another method involves adjusting a first flow conditioner associated with a first concentrate to cause the first concentrate to pass through the first flow conditioner at a metered rate. Then, the concentration of the first concentrate is measured to determine the amount of the concentrate sent to the mixing container. When the predetermined amount is sent, the dispatch of the first concentrate is terminated, and the second concentrate is weighed. Adjusting the second flow conditioner associated with the second concentrate so as to pass through the second flow conditioner at the set speed, measuring the concentration of the second concentrate, and sending it to the mixing vessel. The amount of concentrate to be determined is determined, and when the predetermined amount is expedited, the expedited concentration of the concentrate expedited to the mixing vessel is terminated, and adjustment, passing, measurement and termination are repeated for each additional concentrate, and the Providing an aqueous solution comprising each of the concentrates. Such a method provides that at least one concentrate is provided in a substantially dry form, ie, a plurality of concentrates, which may be initially multiple and may not be provided in one or liquid form. Applicable to objects. To make the dialysis fluid, for example, the electrolyte and the osmotic agent can be provided in a solid concentrate, such as a powder, and the acid can be provided as a liquid concentrate.

In one embodiment, the measure comprises a flow regulator associated with each concentrate so that a metered volume of each concentrate is measured while measuring the concentration of the concentrate during use of the device. To the mixing vessel via a valve, and a predetermined amount of concentrate is expedited to the mixing vessel. For example, a first flow conditioner coupled to the first concentrate, a second flow conditioner coupled to the second concentrate, and an additional flow conditioner coupled to the additional concentrate may be provided.

The pumping operation of the concentrate stream can be performed by a plurality of mechanisms, such as, for example, a metering pump associated with each concentrate. In one embodiment, the pump is arranged to pump each concentrate to a mixing vessel. Thus, the use of a pump associated with each concentrate can be avoided, and the cost, size and weight of a system containing various concentrates can be reduced, for example, as in the case of dialysis fluids. .

Similarly, a plurality of concentration measuring means associated with each concentrate may be further provided, but each concentrate may alternatively pass through the same measuring means. This can reduce the cost, size and weight of the system. Also,
Since the measuring means measures the concentration of each concentrate individually, each predicted concentration can be selected and set up to provide an accurate measurement over a sufficiently wide range. This increases the conductivity by adding additional concentrates,
Since the measuring means is required to be accurate over a wide range, for example sufficient to encompass the conductivity of the first concentrate, the conductivity of the solution stored in the mixing vessel, the combined second It is intended as a system that uses measuring means to measure the greater conductivity of the first and second concentrates, and the like. Also, in such a storage system, the measurement error resulting from the measurement of the first concentrate is added to the measurement error, such as the second concentrate, and subsequent concentrates are measured with lower accuracy than the initial. This does not occur if the concentration of each concentrate is measured individually, as it is only due to erroneous measurements.

The measuring means may include at least one measuring radix, such as two measuring mechanisms, providing extras for the system and thus providing additional stability. The measuring means may include other forms of meter such as a pH meter or an ion selectivity meter, but preferably includes a conductivity meter.

The measures can be arranged to dilute the concentrate after it leaves each chamber and before the concentrate passes through the mixing vessel. By controlling the amount of dilution, the concentration of the component materials pumped to the mixing vessel may also start from a different pre-diluted concentrate, which is the case for concentrates initially provided in substantially dry form. It can be controlled to a predetermined concentration. Dilution can be performed, for example, by a proportional pump. In one dilution configuration, the configuration includes a condensate stream and a water stream, wherein the concentrate is pumped at a metered rate by the pump along the concentrate stream and water is metered by a second pump along the stream. Pumped at a controlled speed, the concentrate stream is coupled to a water stream, and in use the concentrate and water are mixed to dilute the concentrate before the concentrate passes through the mixing vessel. The concentration of the concentrate or diluted concentrate is measured and the pump is controlled to provide the required dilution ratio to obtain the desired concentration of diluted concentrate.

A convenient method of expediting a predetermined amount of concentrate to a mixing vessel is to pass the diluted concentrate through a mixing vessel at a predetermined flow rate, measure the concentration of the diluted concentrate, and measure the concentration of the diluted concentrate. Multiply the concentration by the flow rate and integrate the product over time to determine the total amount of concentrate that is expedited to the mixing vessel, and once the predetermined amount of concentrate has been expedited to the mixing vessel, remove the diluted concentrate. Terminating passing through the mixing vessel. Accordingly, the measures may include a suitable processor to perform the multiply, integrate and terminate functions.

[0097] A plurality of chambers receiving concentrates are usually provided in place with respect to each other and to the device to ensure that each concentrate is delivered to the appropriate site of the device. You. In one embodiment, the procedure can check whether the correct concentrate is being received at each appropriate site. Thus, the method measures the nature of the concentrate or the nature of the concentrate after dilution downstream of each of the chambers and determines from the measurements whether the concentrate is the expected concentrate from the chamber. Including.

For example, where the property measured is pH, it is difficult to distinguish a concentrate having a neutral pH at any concentration. In one embodiment, the property measured is conductivity. The concentrate can be provided in each chamber in an amount that allows its properties, such as conductivity, to be distinguished from each other when it is subsequently measured. Properties can be measured in the form as supplied from the chamber, ie without additional dilution. When measuring after dilution, the dilution is performed by adding a liquid containing a known amount of water, and the measurement for the expected concentrate is still known.

[0099] The concentration of the concentrate in the mixing vessel can provide the final preparation suitable for the required medical use. However, in order to maintain a reasonable size of the mixing vessel, in one embodiment, the liquid in the mixing vessel passes toward the point of use to dilute the liquid downstream of the mixing vessel.

The dilution is performed by supplying water from the mixing vessel into the water conduit, wherein the liquid in the mixing vessel is pumped at a known rate and the diluted liquid is pumped at a higher known rate, Is discharged from the supply at a flow rate corresponding to the difference between the known flow rate of the mixing vessel liquid velocity and the known flow rate of the diluted liquid. Thus, the degree of dilution is known. To ensure that an accurate preparation is obtained for the diluted liquid, it is checked whether the degree of dilution is correct, for example in connection with its medical use as a peritoneal dialysis fluid. This can be achieved by providing a suitable measuring means, such as a conductivity measuring means. The cost, size and weight of the equipment is determined by measuring the concentration of the diluted liquid downstream of the mixing vessel using similar measuring means to those used to measure the concentration of the concentrate during dispatch to the mixing vessel. It can be minimized by measuring the concentration.

If a common flow path is used at several points downstream of the valve associated with each concentrate, flush the flow path (or a portion thereof) after the concentrate has been dispatched and before the next dispatch. Is preferred. In one configuration, the pump is reversible and connectable to a liquid source so that, when the device is in use, the pump is operated in reverse after pumping the concentrate to pump liquid from the liquid source through the combined flow regulator. To flush the flow path between the liquid supply and a flow regulator such as a valve. The liquid used for the flush is preferably water.

From the foregoing, it can be seen that systems for producing different medical preparations at a point of treatment include additional and advanced aspects. Accordingly, a fifth aspect of the present invention relates to such a system.

In one aspect of the fifth aspect, the invention provides an apparatus for use at a point of treatment, the apparatus using a plurality of concentrates to prepare different peritoneal dialysis fluids from such concentrates. A range of products can be manufactured, each such preparation comprising at least one diluted form of the concentrate based on predetermined formulation information.

Such a device is an improvement over known peritoneal dialysis systems that involve the use of a pre-prepared preparation range, wherein the known system is manufactured remotely from the point of treatment, It must be selected and transported to the point of treatment depending on the preparation required. Instead, multiple concentrates are used by the device to make up the required preparation on site with prescribing information determined by a physician or other qualified health care professional. This simplifies the manufacturer's inventory control and
The manufacturer does not need to produce different pre-prepared preparation ranges, but can instead supply multiple concentrates. This is also convenient for physicians and patients, who do not have to worry about ensuring that they are provided with a precisely pre-prepared fluid bag.

In another form of the fifth aspect, the invention provides an apparatus for producing peritoneal dialysis fluid for introduction into a patient's peritoneal cavity at a point of treatment, the apparatus comprising: A plurality of chambers for receiving the concentrates, a fluid mixer arranged to mix the concentrates with the liquid to produce a peritoneal dialysis fluid, and a peritoneal dialysis fluid selected from a group of different preparations. A controller arranged to control the fluid mixer to selectively produce; a sterilizer arranged to sterilize at least one of a liquid and a peritoneal dialysis fluid; and a peritoneal peritoneal fluid for the peritoneal dialysis fluid. A patient filling connection arranged in fluid communication with the cavity, the controller being provided with data input means for receiving predetermined prescribing information for the patient, the controller comprising: The apparatus is operable to control a fluid mixer to produce a peritoneal dialysis fluid preparation based on the received predetermined prescription information.

Thus, multiple concentrates can be used to produce a preparation based on a prescription required by the patient and prior to treatment. There is no need to use a different set of concentrates for each preparation, and thus no need for a concentrate set to be dispatched to the point of treatment. Since the process is separate from the expedited process, the treating physician has more freedom, for example, to change the prescription from one treatment to the next. The greater flexibility in the provided formulation allows the patient to be maintained during peritoneal dialysis treatment for an extended period of time before switching to hemodialysis treatment.

In one embodiment, the chamber is provided in the compartment with all the concentrates required to produce the peritoneal dialysis preparation in the form of a compartment in the container. Thus, the use of only one concentrate container to produce different preparations simplifies the use of the system by clinicians and patients.

[0108] The concentrate can include multiple electrolytes, and the controller is selectively operable to produce peritoneal dialysis fluid preparations having different relative electrolyte concentrations.
Thus, the attending physician can vary the relative electrolyte concentration in view of the patient's excess or deficiency for certain salts or ions. Also, this can be done without considering whether a pre-prepared preparation bag is available for use at the point of treatment.

In yet another form of the fifth aspect, the invention provides an apparatus for producing peritoneal dialysis fluid for introduction into a patient's peritoneal cavity at a point of treatment, the apparatus comprising: A plurality of chambers receiving each of the concentrates of the following components: a fluid mixer arranged to produce a peritoneal dialysis fluid by mixing the concentrate with a liquid; and a peritoneum selected from the group of different preparations. A controller arranged to control the fluid mixer to selectively produce the dialysis fluid; a sterilizer arranged to sterilize at least one of the liquid and the peritoneal dialysis fluid; and A patient filling connection arranged in fluid communication with the patient's peritoneal cavity, the concentrate comprises a plurality of electrolytes, and the controller comprises a peritoneal dialysis having different relative concentrations of electrolytes. Operable to selectively produce a fluid preparation.

[0110] The advantages of such a device will be apparent from the description below.

The above description and the following detailed description are merely examples, and can be variously modified and implemented within the scope of the present invention.

[0112] Embodiments of the present invention will now be described, by way of example, with reference to the accompanying drawings, which form a part of this specification, and which are incorporated herein.

Description of Detailed Examples FIG. 1 is a schematic partial perspective view of an apparatus 100 for preparing a peritoneal dialysis fluid for a patient according to a first embodiment of the present invention. The apparatus 100 is connected by a raw water connection 1 to a domestic raw water supply and by an external drain connection 16 to a domestic wastewater system. This external wastewater connection 16 is in the form of a replaceable wastewater pipe. The device 100 is powered by a home power supply via a main electrical connection 20. The concentrated component of the PD fluid is received in a disposable concentrate container 402 and provided to the device 100. 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 of the PD fluid for the patient on the smart card 102 which is read thereby. The device 100 also displays information to the patient and a control panel 104 that allows the patient to control the operation of the device where it is located.
including.

Overall, the device 100 according to the embodiment of the present invention is installed in the patient's house, purifies the raw water exiting from the raw water connection 1 and disposes the purified raw water in a disposable concentration. The PD fluid is mixed with the concentrated PD fluid component from the product container 402 to produce a PD fluid. Next, the device 100 sterilizes the PD fluid and disposes the PD fluid in the disposable fluid line 1.
Directly to the patient's peritoneal cavity via O. During the treatment period, which includes a series of fill and drain cycles, the dialysate of the stale PD fluid is removed and new PD fluid is added to the patient's peritoneal cavity, usually at night when the patient is asleep.

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

Although the device 100 is primarily intended for use in a patient's home, the device 100 can be used in centers such as dialysis clinics and hospitals.
The device includes a control system (not shown) that monitors and controls the operation of device 100 during normal use. In addition to the control system, the device 100 may be separate from the control system and independent of the control system to monitor the correct operation of the device 100 to ensure that patient safety is not compromised (not shown). )including. Control and protection systems can perform functional tests to ensure that the device operates properly.

At the beginning of a treatment period, a user, eg, a patient, is required to confirm several intended treatment variables displayed on the control panel 104. Such variables include, for example, the name of the patient, the volume of PD fluid entering the patient's peritoneal cavity, the glucose concentration of the PD fluid, or the expiration date of the disposable concentrate container 402. Some of these variables are stored on smart card 102. This corresponds to the traditional PD treatment stage where the patient compares the label on the plastic PD fluid bag with the doctor's instructions. Also, at the start of the PD treatment, the patient needs to identify himself 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 tube at the end of the treatment period.

At the beginning of a treatment period, the patient can set, according to his requirements, the required concentration of glucose in the PD fluid required for such a treatment period, within predetermined limits. The glucose concentration is determined by the patient using the control panel 104.
Because the glucose in the PD fluid acts as a penetrant, increasing the glucose concentration will result 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 peritoneal cavity is normally filled with PD fluid in a periodic process at night and the fluid is emptied. The device 100 can also perform periodic peritoneal dialysis, in which the peritoneal cavity is initially filled with PD fluid, and in subsequent cycles a smaller volume than the initial total fill volume is drained from the peritoneal cavity. And replaced with a new fluid of approximately the same volume. Such a peritoneal dialysis treatment can also be performed while the patient is asleep, so the device 100 is typically placed near the patient's couch. Other treatment regimes are also possible.

At the end of the treatment period, the patient's peritoneal cavity may be left filled with PD fluid or the PD fluid may be drained from the peritoneal cavity depending on the patient's condition. Generally, the device 100 is expected to be the only source of PD treatment for a patient. Therefore,
If the patient's peritoneal cavity is filled with PD fluid at the end of the treatment period, it is expected that the peritoneal cavity will be filled with PD fluid at the beginning of the next treatment period. However, the patient's peritoneal cavity can usually be drained or filled using an additional PD treatment device during the treatment period. The device 100 addresses this situation by providing an input means that allows the patient to enter relevant data into the device.

During a typical treatment period, a total of about 8 to 25 liters of PD fluid is infused into and removed from a patient's peritoneal cavity, with each filling volume being 250 milliliters to 3 liters (eg, In the case of periodic peritoneal dialysis, the volume may be small). One treatment period can include up to 20 filling and draining cycles, and up to 25 liters of PD fluid (50 liters if the disposable concentrate container 402 is changed) is supplied to the patient (used Up to 35 liters of fluid (per container) is drained from the patient, with a draining volume of up to 4 liters per cycle.

The patient can instruct the device 100 via the control panel 104 to give up the treatment period, allow the patient to disconnect from the device 100, or omit part of the cycle during the treatment period to provide early treatment. The treatment period can end.

The device 100 includes a timer (not shown) that allows the patient to set the approximate time at which the patient will begin a treatment period, and thus the device 1
00 makes necessary preparations for the treatment period before the patient arrives. Thus, if such a time is set, treatment can begin within 20 minutes, preferably within 10 minutes, after the patient arrives and confirms that a treatment period is substantially needed. If the timer is not preset, the device 100 can take up to one hour to make the necessary preparations for the expedited delivery of dialysis fluid.

The control panel 104 has a 256-color video touch screen provided with a screen saver. The control panel allows the user to set, among other things, the concentration of the glucose level of the PD fluid within predetermined limits, to start, block, restart, or end the treatment period, and to reduce the temperature of the dialysis fluid to 35-40 ° C. To adjust,
It is possible to set a scheduled start time in the future, ie for the subsequent treatment period. The control panel displays the treatment status, the time to the end of the treatment period during the treatment, or the time to the start of the treatment period during the preparation of the treatment period. If requested, the control panel 104 may display the treatment mode (eg, timed or continuous peritoneal dialysis), number of cycles during the treatment period, glucose concentration, accumulated fill volume for the treatment period, accumulated elimination for the treatment period. It displays the volume, the accumulated ultrafiltration volume for the treatment period, the fluid expedited temperature set point, the patient identification or patient entered information from the smart card 102, the treatment period status, and the technical error code. The excess filtration volume is the volume of PD fluid supplied to the patient and the PD discharged from the patient.
The difference in fluid volume. The control panel can also display visual alerts and provide audible alerts that allow the device 100 to alert the patient to operational problems. Also, the control panel 104 can be arranged to display service information and additional information for use by the nurse, such as filling rate and volume, if the nurse can provide a valid identification code.

The device 100 is operated by a service engineer by a laptop computer (laptop).
The signal can be sent via a remote connection, such as a modem (not shown) or directly using an opcomputer (not shown).

The smart card 102 stores the patient's prescription, and for each of the last 20 treatment periods, the prescription, over-filtration volume, surveillance identity, date and time, and the prescribed treatment and delivered prescription. Store any fluctuations, reasons, etc. when notified by the watchdog. The smart card 102 also stores a selected level of acceptable limits for the patient, such as the patient's identity, cycle number and glucose concentration. PD200T manufactured by Gumbro located in Rand, Sweden
Although a distinction can be made between PD200 cards used in M-peritoneal dialysis systems and those suitable for use with the device 100, the physical characteristics of smart cards are PD200TM
Similar to that used in peritoneal dialysis systems.

The information on the smart card 102 may be obtained by connecting a computer (not shown) equipped with a suitable interface to the device 100 by a physician, or by connecting the smart card 102 to a computer (not shown). Can be changed by inserting it into a suitable card reader. Service personnel can also input signals to the device 100 using a computer (not shown) and a data link directly connected to the device.

FIG. 1 a shows the operating system processor 108 and the protection system processor 106.
FIG. 2 shows a block diagram of a smart card reader 103 connected to. The processor operates and monitors the system in a manner already known in the field of dialysis machines. The processor is connected to the control panel 10. Processors 106, 108 are associated with memory devices 110, 112, such as volatile memory, static memory, hard disks, solid state memory devices, and the like.

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

The protection system processor receives data input from sensors and other means of the device, and output control signals for monitoring other processes of the operation system processor and 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. Although the device has been shown as six interconnected functional modules for ease of understanding, each module plays a specific role in preparing for peritoneal dialysis fluid and peritoneal dialysis treatment. These modules include a water preparation module 200, a heat control and sterilization module 300
, A concentrate mixing module 400, a discharge module 500, a cycler and sterilizable connector module 600, and a sampling module 700.

Hereinafter, the overall structure of the fluid path of the device 100 will be described, and a detailed additional description of each module will be given.

The terms used herein, ie, “cleaning”, “disinfection”, “sterilization” have distinct meanings. That is, "washing" simply means removing the sediment in the system, "disinfecting" means neutralizing most bacteria, and "killing" removes all bacteria with a 1/10 ⁶ confidence level. By deactivating, this level is that the theoretical probability of the presence of a viable microorganism is less than 10 ⁻⁶ (Unites States Pharmacopoeia, 2nd edition and Eur
open Pharmacopoeia 1997).

As shown in FIG. 2, raw water from the household supply unit is provided to the water preparation module 200 via the raw water connection unit 1. The water preparation module 200 switches the raw water supply on and off, limits the pressure of the raw water supply, and monitors the availability of the raw water supply to enable other parts of the apparatus. Control the water supply to the module. Also, the water preparation module 200 reduces or controls the level of dissolved gas, the level of chemical and microbiological contamination present in the water supplied to the concentrate mixing module 400. The water preparation module 200 is operable with potable water as defined generally in the United States Environmental Protection Country for drinking water, November 1996, and 1-6.
Pressure of bar gauge (100-600 kPa or more than atmospheric pressure) and 5 ° C-30
Operable at a temperature of ° C.

The water preparation module 200 is connected to the thermal control and sterilization module 300 via five fluid connections 2a to 2e. The cooling water output connection 2a supplies pressure controlled soft water for use in the cooling function of the heat control and sterilization module 300. The temperature of the cooling water is increased in the heat control and sterilization module 300, at least in part, by the water used for cooling purposes. In this manner, the water preparation module 20
The water returned to zero is preheated using waste heat from other parts of the apparatus 100, improving the efficiency of the water preparation module. The cooling water is supplied from the heat control and sterilization module 300 to the water preparation module 2 via the cooling water return connection 2b at a controlled temperature of about 30 ° C.
Returned to 00.

The purified water provided by the water preparation module 200 passes through the heat control and sterilization module 300 via the purified water connection 2c. The wastewater from the water purification process passes through the heat control and sterilization module 300 from the water preparation module 200 and is cooled via the purification wastewater connection 2d.

Excess gas is exhausted to the atmosphere through the water preparation module 200 and the shielding air vent 17. The water preparation module 200 can exhaust air into and out of the thermal control and sterilization module 300 via the patient heat exchanger exhaust connection 2e.

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

The water preparation module 200 has a connection for the disinfecting cartridge 210, which supplies a chemical disinfectant for disinfecting the water preparation module 200 as needed.

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

The heat control and sterilization module 300 is supplied to the water preparation module 200 via the cooling water return connection 2b, and the temperature of the water supplied to the concentrate mixing module 400 via the mixed water supply connection 4a. Control. Heat control and sterilization module 30
One important role of zero is to prevent heat from being wasted and to allow the heating operation to proceed, so that the device does not require more power than can be supplied by a household power socket. The device 100 is 90-140V, 10A, 50 / 60Hz
(Eg, North America and Japan) or 198-253V, 10A, 50 / 60Hz (
For example, it is designed to work with mains power in Europe. Therefore,
The maximum power consumption of the device 100 is between 0.9 kW and 2.5 kW. While filling the patient with PD fluid, the power consumption is about 1.2 kW. Power supply is 300ml
If sufficient power cannot be provided to sterilize a PD fluid at a flow rate of / min, the flow rate is reduced to, for example, 150 ml / min, 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 PD fluid for disinfection and sterilization during filling of the patient.

The connection between the water preparation module 200 and the heat control and sterilization module 300 has been described above. The heat control and sterilization module 300 supplies the purified water whose temperature is controlled to the concentrate mixing module 400 via the mixed water supply connection 4a. The output of the concentrate mixing module 400, for example, a PD fluid, is returned to the thermal control and sterilization module 300 via the mixing module output connection 4b.

The fluid entering the heat control and sterilization module 300 from the mixing module output connection 4b passes through an input volumetric flow meter 350, which is supplied to the patient when the device supplies PD fluid to the patient. Measure the volume of the fluid. An output volume flow meter 350 is provided in the cycler and sterilizable connector module 600 to measure the volume of fluid removed from the patient. Fluid level fluctuations in the patient's body due to the PD process are calculated by subtracting the volume of fluid expelled from the patient from the volume of fluid delivered to the patient. Such a change is referred to as the over-filtration volume (UF) and is accurate to ± 66 ml (or 0.66% of the total fill volume if large) over the treatment period, preferably ± 33 ml (or large if the total fill volume is large). 0.33%) in the range of -4 liters to +10 liters.

When treating a patient, the germicidal PD fluid is cycled from the thermal control and germicidal module 300 via the germicidal fluid connection 8a and the sterilizable connector module 6
Passing to 00 side. During the sterilization process of the cycler and the sterilizable connector module 600, water at the sterilization temperature passes from the heat control and sterilization module 300 to the cycler and the sterilizable connector module 600 side through the sterilizing fluid connection 8a and sterilizes. It returns to the thermal control and sterilization module 300 via the output connection 8b. The sterilized water is heat-recovered and heat-recovered by the sterilization module 300, and then the cycler and the sterilizable connector module 600 via the sterilization fluid return connection 8c.
Return to.

The heat control and sterilization module 300 is connected to the discharge module 500 via a heat discharge connection 13a used to pass wastewater from the purified water connection 2d to the discharge module 500 after heat recovery. During disinfection, the fluid passes at low pressure from the discharge module 500 to the heat control and sterilization module 300 side via the heat recovery drain connection 13b for heat recovery. This fluid is supplied to the heat recovery drain return connection 1 after heat recovery.
It returns to the discharge module 500 via 3c.

The concentrate mixing module 400 mixes the concentrated PD fluid with the required formulation
The appropriately diluted PD fluid is supplied to a heat control and sterilization module 300 for sterilization. The concentrate mixing module 400 also supplies a cleaning agent to a downstream module of the device to control air exhaust from the fluid circuit while minimizing microbiological contamination.

As described above, purified water is supplied from the heat 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 supplied to the mixing module output connection. Thermal control and sterilization module 3 via 4b
Returned to 00. The concentrate mixing module 400 is also provided with an air vent connection 6 to the atmosphere that allows filling and discharging of the fluid system, and a mixing module discharge connection 15 used to supply water to the discharge module 500 at the disinfection temperature. I have. The water at the disinfecting temperature is supplied to the water preparation module 2 via the reverse osmosis disinfecting connection 3.
00 is supplied.

The PD fluid is connected to the manifold 404 of the concentrate mixing module 400 and is prepared by the concentrate mixing module 400 from the concentrated components of the PD fluid provided in the disposable concentrate container 402 surrounded by the manifold cap 406. You.

With reference to the drain module 500, this module controls the flow of fluid to the external wastewater connection 16 to drain the patient's dialysate (fluid removed from the patient at the end of the PD treatment). Provides the required negative pressure. The external wastewater connection 15 can be permanently connected to the domestic sewage system, or can be temporarily connected, for example, clipped onto a toilet bowl. Also, the drain module 500 closes the drain and optionally shuts off the fluid system, stopping flow from the water preparation module to allow for disinfection. The maximum flow rate to the external wastewater connection 16 is 3 liters per minute, and the maximum temperature of the fluid passing through the external wastewater connection 16 is 85 ° C.

Most of the connections to the discharge module 500 have already been described in connection with the other modules of the device. Hereinafter, other connections regarding the cycler and the sterilizable connector module 600 will be described.

The cycler and sterilizable connector module 600 prevents the passage of unsafe chemical composition, temperature or pressure PD fluid, or non-sterile PD fluid through the patient 50 by closing the appropriate supply tubing. . As described above, the cycler and sterilizable connector module 600 is connected to the heat control and sterilizing module 30 via the sterilizing fluid connection 8a, the sterilization output connection 8b, and the sterilization fluid return connection 8c.
Connected to 0. The cycler and sterilizable connector module 600 is connected to the patient 50 via a patient filling connection 9a and a patient discharge connection 9b. The patient connections 9a, 9b are replaced by the patient 50 at the beginning of each PD treatment period and connect to a standard connector on a catheter (not shown) introduced into the patient's peritoneal cavity. Consists of The disposable fluid line 10 is pre-sterilized and provided to the patient in a sterile package. At the end of the disposable fluid line 10 seen from FIGS. 19 to 21 is provided a pierceable membrane 634 which is connected to the cycler and the sterilizable connector module 600.
Maintains the sterility of the disposable fluid line 10 with the cap (not shown) on the catheter connector 654 until the time the fluid line 10 is used.

[0154] The cycler and sterilizable connector module 600 includes a sterile fluid connection 8a.
The fluid circuit from to the sterilization output connection 8b including a pierceable membrane 634 at the end of the disposable fluid line 10 is arranged to be heat sterilizable with water at the sterilization temperature exiting the thermal control and sterilization module 300. The cycler and sterilizable connector module 600, once the membrane 634 of the fluid line 10 is pierced, maintains the sterility of the fluid circuit until the end of the treatment period and ensures that fluid passes only to the intended patient. I do.

The cycler and sterilizable connector module 600 includes a negative pressure connection 14 a to the discharge module 500 for discharging dialysate from the patient's peritoneal cavity, and fluids other than dialysate from the cycler and sterilizable connector module 600. Is provided with a peripheral pressure discharge connection 14b that is used to discharge air.

The sampling module 700 is connected to the disposable fluid line 10 via the sampling interface 11 and, if requested, a 15 m for analysis.
Collect 1 dialysate sample. The sample shows the average composition of dialysate excreted over the entire cycle of the treatment period.

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

Water Preparation Module 200 FIG. 3 shows a detailed structure of the water preparation module 200. Water leaving the main household supply flows into the water preparation module 200 via the raw water connection 1. The flow of water can be completely shut off by the inflow valve 202. Water passes from the inlet valve 202 through a 30 micron particulate filter 204, which protects the moving section of the water preparation module 200 from coarse particulates in the raw water supply. Filter 2
04 prevents components downstream of the water preparation module 200, such as reverse osmosis membranes or particulate filters, from being damaged or blocked.

The filtered water passes through, for example, a water softener 206 in the form of an ion exchange column. Wastewater from the water softener 206 generated during the regeneration of the water softener 206 is discharged to the discharge module 500 via the water softener valve 268 in a normally closed state, the purified wastewater connection 2d, and the heat discharge connection 13a of the heat control and sterilization module 300. pass. Water softener 206 is reverse osmosis membrane 23
The fluid components of the water preparation module 200, such as 8, 252, are protected from limescale, which can degrade the performance of these components. The supplied water is used to prevent lime scale from accumulating.
It is important that the reverse osmosis membranes 238, 252 be operated to be soft.

The softened water is in the form of a tank equipped with a floating valve,
The material exiting from 00 passes through an isolator 208 which prevents backflow into the main supply and reduces the pressure of the water from main pressure to atmospheric pressure. Air from the isolator 208 flows to the atmosphere from the isolator air vent 17 that can be opened and closed by the isolator air vent valve 209. In addition, the isolator 208 can receive air exiting the thermal control and sterilization module 300 via the patient heat exchanger vent connection 2e and pass the air through the module.

A branch of the fluid path including the disinfection cartridge 210 is connected to the main fluid path downstream of the isolator 208, which will be described later. The softened water in the main fluid path is supplied from the isolator 208 to the heat control and sterilization module 3 via the cooling water output unit 2a.
00 and before returning to the water preparation module 200 via the cooling water return connection 2b, the heat control and sterilization module 300 for cooling and preheating purposes.
At a controlled temperature of about 30 ° C. The elevated temperature of the water due to preheating in the thermal control and sterilization module 300 reduces the power required to pump the 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 via the cooling water return connection 2b passes through a series of components 214-224 that remove dissolved gases from the water. These components are a proportional valve 214, a degassing throttle valve 216, an expansion chamber 218, a degassing pump 222, and a degassing chamber 224. In operation,
The water leaving the degassing chamber 224 is supplied to the degassing pump 22 which is a gear pump.
2, the gas is recirculated through the degassing throttle valve 216 via the proportional valve 214. The pressure drop of the water by the degassing throttle valve 216 forces the gas dissolved in the water to escape from the solution and begin to form bubbles in the water. The pressure drop across the degassing throttle valve 216 is a function of the flow rate through the valve, which is maintained constant by recirculation from the degassing chamber 224 at the flow rate set by the degassing pump 222.

The degassing chamber 224 includes a water level sensor 225 such as an ultrasonic level sensor for detecting a water level in the chamber. When the water level in the degassing chamber 224 decreases, the water level sensor 225 outputs the water from the cooling water return connection portion 2b until the water level in the degassing chamber 224 returns to the maximum water level.
Controls the operation of proportional valve 214 so that proportional valve 214 is adjusted to replenish the water recirculated. The recirculated flow exiting the degassing chamber 224 is reduced to maintain a constant flow through the degassing restrictor 216. Thus, the degassing chamber 2 on the downstream side toward the reverse osmosis membranes 238 and 252
The water flow leaving 24 is replaced by the same flow of water leaving the cooling water return connection 2b. However, the flow rate from the degassing throttle valve 216 remains constant without correlation with the flow rate on the downstream side exiting the degassing chamber 224 due to the operation of the proportional valve 214. The constant flow rate of 900 ml / min through the degassing throttle valve 216 is 800 mba
provides a pressure drop of r (80 kPa), which is sufficient for effective degassing.

The depressurized water passes from the degassing restrictor 216 to the expansion chamber 218, which has time to increase the size of bubbles generated during the rapid pressure decrease in the restrictor. Delay the flow sufficiently. Some of these bubbles rise to the surface of the water in the expansion chamber 218, forming a small gas head space within the expansion chamber 218. The gas pipe 21 connecting the head space in the expansion chamber 218 between the fluid path between the expansion chamber 218 and the degassing pump 222
9 is provided in the expansion chamber, and the expansion chamber 2 is
Bubbles are mixed into the fluid discharged from 18. The gas and water mixture is exhausted from the expansion chamber 218 by a degassing pump 222 and the water pressure is monitored by a degassing pressure sensor 220 to ensure that the pressure is low enough for effective degassing. . The degas pump 222 pumps gas and water into the degas chamber 224 where the gas is exhausted to the isolator 208 at atmospheric pressure. As described above, the water level sensor 225 in the degassing chamber 224 is
In the case where the water level is reduced by the water discharged from the degassing chamber 224 by the downstream component of 00, a part of the flow passing through the degassing throttle valve 216 is directly increased from the cooling water return connection portion 2b. By opening the proportional valve 214, the fluid flow is controlled by the proportional valve 214. Thus, the water preparation module 20
Fluid continuity in the trailing part of zero is guaranteed.

The pressure drop associated with the degassing throttle valve 216 occurs because a bypass is made from the upstream of the proportional valve 214 to the degassing pressure sensor 220 under the control of the degassing bypass valve 226. Without, disinfection can be performed. The degassed water from the degassing chamber 224 is supplied to a reverse osmosis pump 236 (Ten US).
Procon Products Div. / Roehlen I
The product is discharged via an influent conductivity meter 228 by the model name Procon 1608 from Ndustries, which conducts the influent temperature sensor 230.
At the same time, the conductivity of the water is measured. Each conductivity measurement of water (or PD fluid) by the device 100 of the present invention is accomplished by a temperature measurement because the measured conductivity of the solution varies with temperature. The conductivity measurement is compensated by a reference to temperature taken to indicate the ionic concentration in the water (or PD fluid).

After measuring the conductivity, the water passes through an activated carbon filter 232, which is manufactured by Gambro AB part no. K06
Commercially available as 735001, the purpose of the filter is to remove free chlorine from water and adsorb some organic contaminants. Chlorine in the water can damage the membrane surface of the reverse osmosis unit 238, 252.

The water passes through the activated carbon filter 232 and passes through the 5 micron particulate filter 234, which is not trapped by the first filter 204 and contaminates the reverse osmosis membrane of the units 238, 252. An unspecified amount of carbon or other particulate matter is removed from the water.

The filtered water is passed by a high pressure reverse osmosis pump 236, preferably a rotary vane pump, through the first membrane surface of a reverse osmosis membrane unit 238 (Type HSRO / 2521 / FF, commercially available from Dow Film Tech, USA). After passing through the first reverse osmosis output throttle valve 240, the purified wastewater connection 2d and the heat control and sterilization module 30
0 to the discharge module 500. The high pressure of water passing over the first membrane surface of the first reverse osmosis membrane unit 238 causes an osmotic counterpressure caused by ions in the liquid in which a portion of the water is maintained.
Is overcome to the extent of the reverse osmosis permeation to pass through the membrane of the reverse osmosis membrane unit 238. The residue, including any impurities present in the water, passes through the first reverse osmosis output throttle valve 240 and reaches the purified wastewater connection 2d. The first reverse osmosis output throttle valve 240 maintains the pressure applied to the first membrane of the reverse osmosis membrane unit 238 to ensure effective reverse osmosis.

To detect contamination of the first reverse osmosis membrane unit 238, a first reverse osmosis differential pressure sensor 242 is provided, wherein the inflow to the first reverse osmosis membrane unit 238 and the waste stream exiting the unit ( The pressure difference between the first reverse osmosis output throttle valve 240) is measured. If the membrane of the first reverse osmosis unit 238 begins to contaminate, the membrane's resistance to tangential flow between the inflow and the waste stream will begin to increase. The differential pressure increases due primarily to constant flow pumped from the reverse osmosis pump. If the pressure difference increases above 0.5 Bar, this is detected by the differential pressure sensors 242a, 242b and the membrane is considered to be contaminated.
If the membrane of the reverse osmosis unit 238 begins to become contaminated, the pressure drop across the membrane will increase, as detected by the pressure sensors 242a, 242c.

The first reverse osmosis differential pressure sensor 242 is formed of two cavities separated by a diaphragm, and one cavity is formed by the first reverse osmosis membrane unit 23 as shown by a circle 242a.
8 is in fluid communication with the previous point, and the other cavity is in front of the first reverse osmosis output restrictor 240 as shown by circle 242b or reverse osmosis membrane unit 2 as shown by circle 242c.
38. It is in fluid communication with a point on the wastewater output of the first reverse osmosis membrane unit 238 after the 38 membrane. The differential pressure is measured by monitoring the deformation of the diaphragm towards the cavity. The control system does not need to measure absolute pressure at the location of the first reverse osmosis differential pressure sensor 242a because only differential pressure is required to detect contamination of the reverse osmosis unit 238.

The conductivity of the reverse osmosis water passing through the first membrane of the reverse osmosis membrane unit 238 is measured by the first reverse osmosis conductivity measuring device 246 together with the first reverse osmosis water temperature sensor 248.

First Reverse Osmosis Membrane Bypass Valve 2 for Use During Disinfection of Water Preparation Module 200
50 are provided, the function of which will be described later.

Downstream of the first reverse osmosis unit 238 is provided a second reverse osmosis unit 252 (type HSRO / 2521 / FF, commercially available from Dow Film Tech, USA). The use of two reverse osmosis membrane units 238, 252 provides higher purity water than using a single membrane unit, and provides additional stability if one membrane is ruptured. Is done. When measured from the conductivity side, the first reverse osmosis membrane unit 238 filters about 98% of impurities from water pumped across the unit by the pump 236, and the second reverse osmosis membrane unit 252 removes the remaining impurities 2 Filter 80% in%. The quality of water required by the device 100 is very high and can be difficult to achieve consistently for a single reverse osmosis membrane. If one of the reverse osmosis membranes 238, 252 ruptures, the other reverse osmosis membrane will detect contamination by the protection system and provide purified water for a short time before the device 100 shuts down.

Wastewater leaving the first reverse osmosis membrane unit 252 is similar to the first reverse osmosis membrane unit 238 except that the wastewater is further regenerated at the input of the reverse osmosis pump 236 via the disinfectant selection valve 256. And passes through the second reverse osmosis output throttle valve 254 in the following manner. This is possible because the wastewater leaving the second reverse osmosis unit 252 is already quite pure by passing through the first reverse osmosis unit 238. The regeneration process improves the overall water consumption efficiency of the device of the present invention. Typically, a 750 ml / min water volume is removed from the degassing chamber 224 by the reverse osmosis pump 236 during operation of the device.
Such a flow rate is 250 ml / mi regenerated from the second reverse osmosis membrane unit 252.
n to the first reverse osmosis membrane unit 23
It is pumped toward 8. From this 1000ml / min water volume, 500m
1 / min passes through the purified wastewater connection 2d, and 500 ml / min of purified water passes through the first reverse osmosis membrane unit 238 and reaches the second reverse osmosis membrane unit 252. In the second reverse osmosis membrane unit 252, the water amount of 250 ml / min passes through the purified water connection part 2c through the reverse osmosis membrane, and the flow rate of 250 ml / min further decreases the first water amount.
It is reproduced on the input section of the reverse osmosis membrane unit 238.

A second reverse osmosis differential pressure sensor 258 is installed to detect contamination by measuring the pressure difference between the inflow and wastewater of the second reverse osmosis membrane unit 252. This operation is similar to that described above in connection with the second reverse osmosis differential pressure sensor 242, wherein 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 the water provided to the second reverse osmosis membrane unit 252 and to prevent the pressure from increasing due to a change in the output demand at the purified water connection unit 3c, the second reverse osmosis membrane is used. A reverse osmotic pressure relief valve 260 is provided between the inflow to unit 252 and the waste effluent from the second reverse osmosis membrane unit. Second reverse osmosis membrane unit 252
It should be noted that the output demand from the lab changes from a total power, for example 250 ml / min, to zero and to any value in between during a given time period. If the output from the second reverse osmosis membrane unit 252 decreases or becomes zero, the relief valve 26
0 branches the water in parallel with the throttle valve 254, whereby the first reverse osmosis membrane unit 23
8, the operation state almost the same as the overall output is maintained. Such an operation also reduces water consumption.

A second reverse osmosis conductivity measuring device 262 and a second reverse osmosis temperature sensor 264 are provided at the output of the second reverse osmosis membrane unit 252 to measure the conductivity of the output water, so that the water is converted into ions. Ensure that the ingredients have been sufficiently purified. An output water pressure sensor 266 is provided downstream of the second reverse osmosis temperature sensor 264 to measure the pressure of the water output through the purified water connection 2c and the heat control and sterilization module 300.

During disinfection of the water preparation module 200, the disinfectant selection valve 256 is opened to guide the waste stream from the second reverse osmosis membrane unit 252 via the disinfection cartridge 210. The disinfecting cartridge 210 contains a chemical disinfectant such as an aqueous solution of peracetic acid (a widely recognized disinfectant) that is diluted by a water stream. During disinfection, the disinfection valve 212 is opened,
The main valve 202 is closed and the flow through the purified wastewater connection 2d is
0 prevents it. The flow valve of the isolator 208 prevents backflow through the water softener 206. The first reverse osmosis membrane bypass valve 250 is opened, and the first reverse osmosis membrane unit 238 is opened.
Effluent from the clarified wastewater connection 2d closed by the discharge module 500
Instead of passing through the discharge module 500 via the first reverse osmosis unit 23
8 is returned to the output side. The degassing bypass valve 226 is opened to allow fluid to flow therethrough. Therefore, it can be seen that a recirculation 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. However, to disinfect the fluid path between the disinfectant select valve 256 and the reverse osmosis pump 236, the disinfectant select valve 256 is closed and the disinfectant select valve 256 is placed in the fluid channel between the second reverse osmosis restrictor 254 and the disinfectant select valve 256. The already existing disinfectant fluid circulates through the disinfectant selection valve 256 and through the reverse osmosis pump 236.

An additional recirculation path is provided from the gas output of the degassing chamber 224 through the isolator 208 and the degassing bypass valve 226 so that the disinfecting fluid can be circulated through the isolator 208. The degassing bypass valve 226 is opened to allow fluid to flow through the valve, and the pressure of the disinfecting fluid is not reduced by the degassing throttle valve 216, which allows peracetic acid to form hydrogen peroxide. Therefore, the efficiency is reduced. Similarly, in the case of hot water disinfection, a drop in pressure through the degassing throttle valve 216 can cause the water to boil. Even if the degassing bypass valve 226 is opened,
A portion of the disinfecting fluid continues to pass through the degassing throttle valve 216 to disinfect the fluid path.

Once all components downstream of the water softening mechanism 206 have been disinfected, the disinfecting fluid passes through the drain module 500 via the purified wastewater connection 2d.

Water at the disinfecting temperature is introduced to the output side of the second reverse osmosis membrane unit 252 via the reverse osmosis membrane disinfection connection part 3, and the components of the water preparation module on the downstream side of the second reverse osmosis membrane unit 252 are removed. disinfect.

In the case of heat disinfection of the water preparation module 200, the disinfectant cartridge 210 is unnecessary, and the water is heated by the heat control and sterilization module 300 between the cooling water output unit 2a and the cooling water return connection unit 2b during disinfection. You.

Thermal Control and Disinfection Module 300 FIG. 4 shows the structure of the heat control and disinfection module 300 in detail. Water from the cooling water outlet 2a of the water preparation module 200 is guided to the purified waste heat exchanger 324, and this water passes from the purified waste connection 2d through the purified waste heat exchanger 324 to the heat discharge connection 13a. Preheated by flowing water. The water heated by the purified waste heat exchanger 324 is supplied to the electric water heater 3 before exiting the cooling water return connection 2b.
Heated by 22 to maintain an optimal operating temperature for water preparation module 200, typically 30 ° C.

In the heat control and sterilization module 300, during normal operation, water passes through the patient output heat exchanger 314 and the recirculation limiter 310 and is circulated by the geared pump type patient output heat exchanger pump 316. Through the aquarium patient output heat exchanger 314, fluid passes from the on-line autoclave 375 (described below) into a sealed transition tube. PD to be supplied to the patient while the water tank is maintained at a constant temperature by the recirculating water
Maintain the fluid at the desired distribution temperature. If the temperature of the recirculating water is too high, the heated water is removed from the patient output heat exchanger 314 and the water heater 322 by opening the patient output heat exchanger drain valve 318.
Through the cooling water return connection portion 2b. A corresponding amount of cold water is discharged from the cooling water outlet 2a of the water preparation module 200 by the patient output heat exchanger pump 316 until the temperature of the heating tank of the patient output heat exchanger 314 reaches the target level.

If it is not desirable to release heat from the patient output, for example, because the patient output fluid line is sterilized at elevated temperatures, the patient output heat exchanger 314 opens the patient output heat exchanger drain valve 318 and vent valve 320. Drained under the influence of gravity.
The air flowing from the isolator 208 through the patient output heat exchanger vent connection 2 e enters the patient output heat exchanger 314 via the vent valve 320 and the air outlet restrictor 312. If the patient output heat exchanger 314 is filled with air instead of water, the heat transferred from or to the patient output fluid is negligible. In such a case, the patient output heat exchanger pump 316 is stopped. The patient output heat exchanger 314 is refilled by opening the vent valve 320 for venting air and reactivating the patient output heat exchanger pump 316 with the patient output heat exchanger drain valve 318 closed.

The purified water produced by the water preparation module 200 reaches the heat control and sterilization module 300 via the purified water connection 2c. Purified water is disinfected heat exchanger 326
Pass through. At this time, while the concentrate mixing module 400 is disinfected, the disinfecting heat exchanger 326 moves from the heat recovery drain connection portion 13 b to the heat recovery drain return connection portion 13.
It is used to preheat purified water by recovering heat passing in direction c. The preheated water exiting the disinfection heat exchanger 326 is heated by the electric disinfection heater 330 to the disinfection temperature. During normal operation of the apparatus, the disinfecting heater 330 is used to control the temperature of the water supplied to the concentrate mixing module 400 exiting the mixed water supply connection 4a.

While disinfecting the drain module 500, water from the purified water connection 2c is bypassed to the disinfection heat exchanger 326 via the disinfection heat exchanger bypass valve 328,
Water that has escaped from the heat recovery drain return connection portion 13c is maintained at a disinfection temperature of 85 ° C. The disinfection heat exchanger bypass valve 328 is used only during disinfection of the drain module 500.

The PD fluid made from the concentrate mixing module 400 enters the thermal control and sterilization module 300 via the mixing module output connection 4b. This fluid passes through an input volume flow meter 350 that records the flow of PD fluid being filled into the patient. PD fluid is entered by a gear-type positive displacement pump 352, which is monitored by a flow meter 354 that ensures operation of the pump at the target volumetric flow rate. The output speed of the volumetric pump 352 is also adjusted so that the discharge speed of the volumetric pump 352 also ensures accurate operation.
Monitor independently by 50. In order to prevent the fluid from boiling at 150 ° C., the positive displacement pump 352 has the speed and pressure required for on-line autoclaving, ie, 300 ml / min and 6 bar absolute.
Extrude the PD fluid at (600 kPa). The gear pump was selected to ensure that the water passed through the online autoclave 375 was pressurized to the pressure required to heat it to the sterilization temperature.

[0189] During normal operation of the device 100, the PD fluid is supplied to an online autoclave (OL).
A) Enter the online autoclave 375 through the input valve 356 of the 375. At this point, the pressure of the PD fluid is monitored with two independent OLA pressure sensors 358. One of the two OLA pressure sensors 358 provides for reading the pressure transmitted to the device control system, and the other sensor ensures that patient safety is not compromised in the event of device malfunction. For reading the pressure transmitted to another protection system (see FIG. 1a). In such a system, pressure, temperature and conductivity sensors provided for monitoring parameters important to patient safety are all thus overlapped. By thus independently double checking the safety measures of each patient, it is possible to prevent any danger to the patient due to malfunction of a single sensor. Downstream of this OLA pressure sensor 358, the PD fluid is supplied to the first OLA heat exchanger 3
60 and a second OLA heat exchanger 362, which recovers heat from the fluid exiting the OLA heat tank 364, thereby recovering heat from the OLA heat tank 364.
Preheats the PD fluid entering the chamber. The OLA heating tank 364 is an oil heating tank heated by an electric heater 365, and includes a recirculation pump 366 (gear type pump) and a heating tank temperature sensor 368. Oil or ethylene glycol is circulated by a recirculation pump 366 through a heating fluid path 367 including an oil tank,
D fluid (or water) passes through sterile fluid path 369. This heating fluid path 367
And the germicidal fluid path 369 is separated by a thermally conductive partition.

To ensure sterilization of the liquid discharged from the OLA heating tank 364, a sterilization process is performed.
Define a parameter representing the germicidal value. This parameter is for example the OLA heating tank
Algorithm for modeling the temperature distribution inside the 364 and affects the sterilization process
, The value of at least one other parameter that affects
The flow rate Q of the liquid to be sterilized in the chamber, the temperature of the liquid to be sterilized entering the OLA heating tank 364
(T_in) And a heated liquid (ethylene glycol) entering OLA heating tank 364.
) Temperature (T_Hin) And so on. Outlet temperature of the OLA heating tank 364 (
The temperature of the sterilized liquid and the temperature of the heated liquid) are set to the inlet temperature of the OLA heating tank 364.
Since it is relevant, at the time of calculation, the temperature of the sterilized liquid from the OLA heating tank 364 (
T_out) And / or the temperature of the heated liquid from the OLA heating tank 364 (T_Hout
) Can also be considered.

When defining the parameters representing the bactericidal value for the treatment, the settings for the parameters should be high enough to correspond to the effective bactericidal dissolution of the liquid and if the liquid is (peritoneal dialysis solution containing glucose). If heat-sensitive), select one that is as low as possible to prevent or limit degradation of the liquid to be sterilized.

In operation, the control system of the apparatus 100 uses the algorithm of the temperature distribution in the OLA heating tank 364 and the OLA temperature sensor 370, the heating tank temperature sensor 36.
8 and the temperature and flow rate data measured by the input volume flow meter 350 are programmed to calculate a parameter value representing a sterilization value for the process at a constant cycle. Each time a new value for a parameter is calculated, the control system checks whether the calculated value obtained is higher than the set value to ensure that the liquid has been sterilized. A temperature sensor 379 can also be used to obtain the temperature of the liquid to be sterilized by the OLA before entering the heat exchanger. .

[0193] The checking process to confirm the effective sterilization of the liquid can be passive. The reason is that if the sterilization condition is an important characteristic of the PD fluid, the choice of flow rate for the liquid to be sterilized can be limited by a limited number (for example, three) of different predetermined values, thereby allowing other requirements for the device. A standard operating mode of the OLA 375 can be proposed in which all operating parameters are preset for a given flow rate. It is preferred that the operation of the device be as simple as possible. In such a case,
The check process described above is used only for confirmation of sterilization.

It is also possible to propose an operation mode for the OLA 375 in which the flow rate of the liquid to be sterilized within a predetermined value range can be freely selected. In this case, the control system calculates other operating variables for the device, in particular the temperature of the heated liquid as measured by the temperature sensor 368, from the selected flow rate and set point for the parameter representing the sterilization value. During operation,
The control system periodically adjusts the flow rate of the positive displacement pump 352 and / or the temperature of the heated liquid circulated by the recirculation pump 366 such that the calculated value of the parameter is always greater than the set value.

The parameter expressed in Fo (expressed in minutes) is used as a parameter representing the bactericidal value for the bactericidal process in the literature (see page 288 of the European Pharmacopoeia 1997, or page 23 of the US Pharmacopoeia 23). ing.

Fo is the total sterilizing effect accumulated during the sterilizing treatment, or the reference temperature T is 250 °
The disinfection value F ^Z _T corresponding to F (121.1 ° C.) and the thermal deactivation value Z corresponding to 18 ° F. (10 ° C.). The thermal deactivation value Z represents the increase in temperature multiplied by 10 for the rate of degradation of a particular microorganism. Z = 10 ° C. is another spore-forming microorganism, Bacillus stearothermophilus.
) A theoretical microorganism that is more heat resistant than a microorganism that is reputed to be more heat resistant. The standard formula for Fo can be expressed as Equation 1.

Equation 1 describes the case where the liquid to be sterilized flows permanently and the heating means used to increase the temperature of the liquid to be sterilized cannot heat the liquid to the same temperature at all points in the heating chamber. It cannot be applied directly in checking sterilization treatment.

When the heating means is arranged along a part of the liquid circulation pipe for circulating the liquid to be sterilized, Equation 2 can be used to calculate Fo.

[0199] 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 sterilizing fluid path 369 through the OLA heating tank 364 Q = liquid to be sterilized through the OLA heating tank 364 T (y) = Equation of liquid temperature distribution with distance from inlet of OLA heating tank 364.

The equation T (y) changes based on the structure of the OLA heating tank 364 and its operation mode. For example, FIG. 8 shows a first example of a heat exchanger used in OLA 375. Such a switch consists of two concentric pipes, the outer pipe forming a sleeve around the inner pipe. A germicidal fluid path 369 is provided inside the inner pipe, and a heating fluid path 367 is provided between the inner and outer pipes.

In operation, the liquid to be sterilized and the heated liquid, for example, ethylene glycol, are circulated along opposite directions in the inner pipe (sterilization fluid path 369) and the outer pipe (heating fluid pipe 367). The inner diameter of the sterilization fluid path 369 is selected so that the flow of the sterilizing liquid is always turbulent within the flow rate range (100-400 ml / min) for operating the OLA 375.

In an exchange having a stainless steel inner pipe and a copper outer pipe and having the size shown in Table 1, T (y) can be expressed by Equation 3 as follows.

[0203] In Equation 3, T _in = Temperature of liquid to be sterilized entering sterile fluid path 369 T _Hin = Temperature of heated liquid entering heated fluid path 367 (measured by heating bath temperature sensor 368).

[0204] Q = liquid flow rate in the germicidal fluid path 369.

[0205] As can be seen from the above embodiments, the measurement of the temperature _{T in} of the liquid to be sterilized enters the OLA heating bath 364, the temperature _{T Hi} of heated liquid entering the OLA heating tank 364
It is possible to always calculate the sterilization value Fo from the above-described formulas for measuring _n , measuring the flow rate Q of the liquid to be sterilized, and modeling the temperature distribution inside the OLA heating tank 364.

As shown in FIG. 4, in a preferred embodiment of the present invention, the OLA heating tank is recirculated by ethylene glycol by a recirculation pump 366 so as to ensure a uniform temperature throughout the OLA heating tank 364. It is a water tank of ethylene glycol to be stirred. The germicidal fluid path 369 passes through a sealed tube OLA tank 364. On the other hand, the principle described above can be applied to the illustrated embodiment.

[0207] Over all operating phases of the OLA 375 producing a disinfecting liquid (water or PD fluid), the control system determines that the calculated disinfecting value Fo always corresponds to the first disinfecting property of the liquid.
Check the sterilization performed by checking if it is greater than the critical value _Fomin1 .

The OLA heating tank 364 heats the PD fluid to a temperature higher than 150 ° C. and maintains this temperature for at least 2 seconds to autoclaving the fluid, thereby ensuring sterility. The flow rate through the OLA heating tank 364 is 300 ml / min. The theoretical Fo value under such conditions is considered to be at least 20 minutes.

[0209] The temperature of the sterilized PD fluid exiting the OLA heating bath 364 is checked by two independent OLA temperature sensors 370 to ensure that it is at the required temperature. Most of the heat from the autoclaved PD fluid is transferred to the first and second OLA heat exchangers 360,3,3.
It is recovered by the PD fluid entering the OLA heating bath using 62. Residual heat is a patient output heat exchanger 31 that ensures a suitable temperature for patient acceptance, ie, 37 ° C.
4 to be collected inside. The temperature of the autoclaved PD fluid is controlled by the patient output heat exchanger 314.
Downstream is checked 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 safe pressure that may be delivered to the patient. The PD fluid, which is autoclaved and pressure and temperature controlled, enters the cycler and the sterilizable connector module 600 via the sterilizing fluid connection 8a.

During sterilization of the cycler and sterilizable connector module 600, fluid discharged by the positive displacement pump 352 flows along another path through the OLA to 130 ° C. instead of 37 ° C. The fluid is maintained at a pressure of 3 absolute bar (300 kPa) to prevent boiling of the fluid. In this case, the fluid is O
It passes through the LA sterilization valve 376 and through a disinfecting heat exchanger 378 for recovering heat from the sterilization output connection 8b of the cycler and sterilizable connector module 600 through the sterilization fluid return connection 8c. The heat recovered by the disinfection heat exchanger 378 is used to preheat the fluid passing through the second OLA heat exchanger 362 for additional preheating. The heating of the sterilizing fluid by the OLA heating tank 364 is similar to the process of autoclaving the PD fluid. However, heat is recovered only by the second OLA heat exchanger 362, not by the first OLA heat exchanger 360 or the patient output heat exchanger 314. With this stage of drainage, the patient output heat exchanger 314 is a poor conductor of heat and contains only air that does not transfer a significant amount of heat from the germicidal fluid. The first
There is no flow through the heat inlet side of the OLA heat exchanger 360. The reason is that if the OLA input valve 356 is closed and the fluid in the heat inflow side reaches the temperature of the fluid in the heat transfer side, heat is not transferred to the heat inflow direction of the first OLA heat exchanger 360. It is. Even though there is no flow, the fluid in the heat inlet side of the first OLA heat exchanger 360 is OLA
It does not boil because it has the same pressure by communicating with the fluid flow passing through the heating tank 364. Therefore, the sterilizing fluid exiting the sterilizing fluid connection 8a has a much higher temperature, 130 ° C., than the fluid being provided to the patient, and is suitable for sterilizing the cycler and the sterilizable connector module 600.

The sterilization of the cycler and sterilizable connector module 600 may be performed by disinfecting all points in the fluid circuit downstream of the OLA heating tank 364 with the sterilizing liquid for a minimum time t2, the second set sterilization value obtained by equation (4). when it is reached to the minimum temperature T ₂ corresponding to _F omin2, revealed that performed effectively.

For at least the same continuous time period as t2, the patient output temperature sensor 372
It can be performed easily sterilized confirmation fluid circuit by in the control system the temperature of the measuring liquid is checked whether exceeds T _2.

Since sterilization of the cycler and the sterilizable connector module 600 is performed with sterile water, the control system must check for sterilization of the liquid and all sterilization of the fluid circuit. In other words, the control system must check whether the disinfection value for the disinfection applied to the liquid is greater than _Fomin1 and check whether the disinfection value for the disinfection applied to the circuit is greater than _Fomin2 .
For these reasons, the temperature of the germicidal liquid ( _required to achieve _Fomin1 )
It must be reduced from a fluid sterilization temperature of 150 ° C. to a circuit sterilization temperature of 130 ° C. (less than 150 ° C. so that the pressure required by the cycler and sterilizable connector module 600 is 3 absolute bars instead of 6 absolute bars). So the second OLA
A heat exchanger 362 is used.

The patient output pressure relief valve 374 operates during sterilization to maintain fluid at a high pressure of 6 bar absolute in front of the relief valve 374 and to prevent the pressure from boiling at 130 ° C. behind the relief valve. At the high pressure of 3 absolute bars required to pass. One skilled in the art knows how such a valve is constructed. When water starts to boil, it is not possible to verify the sterilization of the circuit, since it is not possible to guarantee that all points of the circuit are in contact with water at the minimum temperature for a minimum continuous time. is there.

[0215] The fluid pathways within the device 100 are closely insulated to prevent heat loss during disinfection and / or sterilization. In particular, the relative positions of the hot components are selected so that heat loss is kept to a minimum, i.e., adjacent components keep one another warm. In this way, it can be ensured that the fluid path is maintained at the correct disinfection or disinfection temperature along the entire passage. A temperature sensor 380 may be provided at the connecting portion 8b to check the sterility of the fluid circuit up to the heat exchanger 378.

The heat exchangers 360, 362, 378 are one embodiment of an embodiment like the exchanger shown in FIG. 9 and have a connection on a part of the length of the heating pipe and the fluid pipe. The two sections of the tied pipe are in the form of a tied helical coil. The inside and outside of the cylinder thus formed are covered with a material of an excellent heat conductor.

Other details of the heat control and sterilization module 300 have already been filed by the same applicant as the present invention and are currently moored, and are described in “Method and Apparatus for Sterilizing Medical Liquids”.
(Gambro reference number: HP1310). The aforementioned application (Gambro reference number: HP1310) is hereby incorporated by reference in its entirety and a copy thereof is attached to the present application.

Concentrate Mixing Module 400 FIG. 5 shows the structure of the concentrate mixing module 400 in detail. The concentrate mixing module 400 is connected to the manifold 404 and the manifold cap 40
6 includes a disposable concentrating container 402 covered by 6.

The disposable concentration container 402 includes a plurality of chambers, each of which contains lactic acid 408, a detergent 410 (eg, sodium carbonate powder), sodium hydrogen carbonate 412, sodium chloride 414, calcium chloride 416, It is in the form of a compartment for an aqueous solution of magnesium chloride 418 and powdered glucose 420. The disposable enrichment container 402 receives sufficient material in each compartment according to one of the various prescriptions selected for the patient's PD processing session.

[0220] The range of formation of each of the components of the PD fluid stored in the disposable concentration container 402 and discharged to the patient is shown in Table 2 together with the range of formation for sodium lactate made of lactic acid and sodium hydrogen carbonate. Further, Table 2 gives the mass of the components stored within the disposable concentration vessel 402 and the approximate volume of each compartment 408-420.

The sodium concentration in the PD fluid delivered to the patient is within ± 2.5% of the required volume. The concentration of each of the other components is within ± 5% of the required amount. Here, the filling volume was assumed to be at least 1 liter. The component amounts are selected to correspond to a wide variety of formulations, so that at least one of the components of the dialysis fluid in container 402 is not used at all for a given formulation. There is also. In addition to, or instead of, the components given in Table 2, other components may be included, such as, for example, potassium salts.

[0222] Although the relative arrangement of the compartments 408-420, ie, their order, is shown in FIG. 5 (and FIG. 5a) as an example only, this does not represent a physical order, but rather easily represents the phase of the fluid system. It is the one that was selected. 10 and 11 show the order of the compartments 408-420 in the disposable concentration container 204 according to one embodiment of the present invention.

FIG. 10 shows the structure of the disposable concentration container 402. The compartments 408-420 are individually injection-molded with polypropylene and their lower parts are mounted on a chassis 401. The upper section, such as compartments 408-420, is used to close the upper section of glucose compartment 420, and lid 403 provides a transfer handle for container 402.
Are maintained by each other. As is evident from Table 2, lactic acid compartment 408, sodium chloride compartment 414, and calcium chloride compartment 416 are each approximately 2 times less than detergent compartment 410, sodium bicarbonate compartment 412, or magnesium chloride compartment 418. It has twice the volume. Glucose compartment 420 is much larger than the other compartments 408-418. Each of the compartments 408-418 has at least one connector 407 at its lower portion to be connected to the manifold 404.

FIG. 11 is a partial end view of the disposable concentration container 402 with a portion of the chassis 401 removed, clearly showing the connectors 407 of the compartments 408-420. Glucose compartment 420 has two connectors 407a, 407b, the functions of which will be described below.

FIGS. 12a to 12c show the lid 403 (FIG. 12a) of the disposable concentration vessel 402,
FIG. 13 is a perspective view of a glucose compartment 420 (FIG. 12b) and a chassis 401 (FIG. 12c). As shown in FIGS. 12a-c, the lower surface of glucose compartment 420 is angled to supply glucose powder in compartment 420 toward input connector 407a. Each connector 407 of the compartment 408-420 is received in a corresponding hole 409 formed in the chassis 401.

The corresponding holes 409 are separated from the vertical symmetry axis B of the chassis 401 and are aligned in the vertical direction of the chassis 401 along the offset line A. As described above, since the container 402 is formed to be rotationally asymmetric, when the container 402 is inserted into the device 100, it is prevented from being inserted in an incorrect manner.

The compartments 408-418 snap to their own location and
Reference numeral 20 denotes a chassis 401 using a rivet 411 formed integrally with the compartment 420.
At high temperature. The rivets 411 are fixed in corresponding holes 405 in the chassis 401. Also, the rivets 411 of the compartments 408-418 can be thermally fused at a high temperature.

[0228] Chassis 401 has a connector 407 when container 402 is positioned on its surface.
And a wavy reinforcing scut 413 to protect the The scut or connector is a removable strip 4 to protect the connector 407 during transport and storage.
43.

FIG. 13 shows a magnesium chloride compartment 418 as an example of a small compartment 410, 412, 418. FIG. 14 shows a sodium chloride compartment 414 as an example of a large compartment 408, 414, 416. Compartments 410, 412, 418 of different sizes
And the lower surfaces of 408, 414, 416 are sloped toward connector 407 so that the powder (or liquid) in compartments 408-418 is directed toward the connector. Each compartment 408-418 has a compartment lid 415 which overlies the top of compartment 408-418 after the respective powder or liquid has been filled into the compartment. In this way, it is no longer necessary to fill the compartments 408-418 through the difficult connector 407. The compartment lid 415 is heat welded to each compartment 408-418. As described above, the container lid 403 to be heat welded forms a lid closing the glucose compartment 420.

Referring again to FIG. 5, after sterilization, a new disposable concentration container 402 is connected to the manifold 404 at the start of the PD processing session, and after the PD processing, the disposable concentration container 402 is separated and discarded. The connection motor 422 is connected to the disposable concentration container 402 and serves to connect the container and the manifold 404.

Functionally, the compartments 408-418 of the disposable concentration vessel 402 are of three types.
The first type includes a lactic acid compartment 408, a detergent compartment 410, a calcium chloride compartment 416, and a magnesium chloride compartment 418. Such a first type of compartment is compartment 408,
When the 410, 416, 418 are connected to the manifold 404, the upper region of the interior of the compartment has a ventilation channel 424 that extends from the inside of the manifold 404 to the air opening to the atmosphere. The vent channel 424 is used when water is introduced into the compartment through the fluid channel 426 of this type of container, or when fluid is introduced into the compartments 408, 41.
As it exits through fluid channel 426 from 0, 416, 418, it provides a path for air to exit compartments 408, 410, 416, 418. Fluid channel 42
6 directs fluid to the lower regions inside the compartments 408, 410, 416, 418, so that the water level in the compartments rises and the water comes into contact with all the materials.

Since the first type of compartments 408, 410, 416, 418 are used to receive a small amount of powdered salt, when a sufficient amount of water is introduced into the compartments, An amount of salt that can be completely dissolved without additional agitation is included, or such an amount of salt is already present in the concentrate.

[0233] The second type of compartments 412, 414 are large enough to accommodate all the water required at once to dissolve all the required salt amounts.
Used to receive salt when needed. Therefore, compartment 4
12 receives sodium bicarbonate and compartment 414 receives sodium chloride. Such a compartment includes a combined vent and fluid channel 428 and a combined injection and output channel 430. Inside the compartments 412, 414 of this type, the combined injection and output channels 4 arranged first in the lower region of the compartments
Salt is immersed by the introduction of water through 30 and air is vented from the upper region of the compartment through combined venting and fluid channels 428. In the water injection operation, the interiors of the compartments 412, 414 are filled with water until all the salts in the compartments are deposited. A similar technique is described in EP-A-0278100, which is hereby incorporated by reference in its entirety.

When the salt is completely wet, the water is drained through the combined venting and fluid channel 428. The water seeps into the salt to dissolve the salt, and the salt solution is drained from the lower area of the compartments 412, 414 through the combined injection and output channel 430. Cell 41
The discharge of the salt volume from 2,414 reduces the pressure so that a corresponding amount of water is passed through the combined venting and fluid channels 428 connected to the water source to compartment 412,
Enter 414.

The compartments 412, 414 of the second type are replaced by compartments 408, 410, 416, 4 of the first type.
It can be operated in a manner similar to 18. For example, the compartment is output channel 4
A salt solution filled with water to dissolve the salt therein through (30) can be discharged from the output channel 430 (actually saturated). Since the amount of salt inside compartments 412, 414 of the second type is greater than can be dissolved by the volume of water filling compartments 412, 414, some salt will remain in compartments 412, 414 after draining of the solution. I do. Thus, the compartments 412, 414 are refilled with water to obtain more solution.

If the container 402 is not connected to the manifold 404, the first and second
The physical structure of the types of compartments is similar. The only factors that determine the type of compartment are the compartment contents and the arrangement of valve vents in the mixing module 400.

The third type of compartment is a glucose compartment 420. Glucose is, for example, 50%
It is particularly difficult to dissolve at a high concentration and at a constant rate, requiring recirculation to ensure total glucose dissolution. In addition, the volume of the glucose solution decreases as the glucose is dissolved, such that the glucose compartment 420 requires continuous aeration throughout the dissolution process. Thus, the glucose compartment 420 provides a glucose vent channel 432 that is permanently connected to the atmosphere and a water or recirculated glucose solution in the lower region of the glucose compartment 420 when the disposable concentration vessel 402 is connected to the manifold 404. A fluid input channel 434 to supply;
Particle filter 43 for preventing glucose particles from suddenly entering the fluid system
And a glucose output channel 436 which discharges the glucose solution from the upper region of the glucose compartment 420 through 8.

The inventor has found that monoheath rate glucose, in particular,
Rem) 's Roquette Freres' monopyrogen-free LYCADEX PF / Dextrose has been found to give excellent results, indicating that such glucose requires the quality required by the 1997 edition of the European Pharmaceutical Code. It is possible because it can be purchased at a relatively low price. In addition, the inventors have discovered that anhydrous glucose forms lumps upon addition of water, which prevents effective dissolution. Larger particles are considered to be beneficial in terms of effective dissolution, as larger particles improve flowability and reduce clump formation.

FIG. 15 is a bottom end view of the glucose compartment 420 of the disposable concentration container 402 located on the top surface of the manifold 404. When the container 402 is disposed inside the apparatus 100, the container 402, the cap 406, and the manifold 404 are provided. Indicates the relative position of. The container 402 is provided inside the apparatus 100 so that the container can be slid horizontally along a pair of container support rails 417. The container support rail 417 is coupled to the protrusion 419 above the connector 407 of the container 402 so that the container 402 is maintained vertically on the container support rail 417. The container support rail 417 is driven by a connection motor 422 (see FIG. 5) to raise or lower the container 402 in the vertical direction. If the disposable concentration container 402 is disposed inside the device 100,
In order to prevent external contamination of the manifold 404, the
4 is closed and the inside of the device 100 is naturally opened to the atmosphere when needed. When the container 402 is disposed within the apparatus 100, the coupling motor 422 operates to drive the container 402 along the container support rails 417 from above the cap 406 so that the cap 406 during sterilization. The manifold 40
4 Keep clearly in the top position.

As described below, the manifold 404 of FIG. 15 includes a drain port 441 for draining fluid at the reservoir vent disinfection valve 498.

As shown in FIG. 15, the connector 407 is sandwiched inside the neck of the compartment 420 and seals the compartment 420 during storage.
23 includes an insert 421 having 23.

The insert 421 is welded inside the neck of the compartment 420, including a portion of the protrusion 419 for coupling to the container support rail 417. Each compartment 408-
All 420 connectors 407 are similarly configured.

Within the compartment 420, a central pipe 425 extends to the top of the compartment 420, but is not shown in FIG. Each compartment 408-420 is provided with a vent channel 42.
A central pipe 425 acting as 4 and a combined venting and fluid channel 42
8 and a glucose output channel 436 or a glucose vent channel 432 associated with a particular compartment 408-420.

The upper part (not shown) of the central pipe 425 is larger than the central pipe 425 and can be received inside the annular projection of the compartment lid 415 formed so as to surround the central pipe 425. The cap between the annular protrusion and the wall of the center pipe 425 can act as a filter.

The center pipe 425 is a filter 4 formed by injection molding as shown in FIG.
39.

A plurality of rod-shaped diffusers 4 extending radially outward from the central pipe 425 toward the bottom surface of the compartment 420 between the base of the central pipe 425 and the inclined bottom surface of the compartment 420.
27 are provided. This diffuser 427 is shown in more detail in FIG. The diffuser 427 supports the central pipe 425 inside the compartment 420 and also diffuses the flow of water (or other fluid) into the compartment 420,
A turbulent flow occurs inside which agitates the powdered salt (or glucose) to help dissolve the powdered salt. When the powder is dissolved in the region of the diffuser 427 due to the turbulent flow of water,
The residual powder falls into compartment 420 and the entire powder is dissolved.

Generally, each compartment 408-420 is configured in this manner. As an example of a possible arrangement (not shown), the glucose compartment 420 has a reverse tapered side that extends upward and outward, so that the glucose powder rises inside the compartment when water is added. Can be prevented. If the powder tends to rise, water channels can also be formed around the periphery of the compartment. The water dissolves all the powder in this area, causing the powder to seal off the channel as it falls.

As shown in FIG. 15, the manifold 404 includes spikes 429 for each connector 407. The spikes 429 are arranged to rupture the diaphragm 423 to establish fluid communication between the manifold 404 and the compartment 420. The spikes 429 are removably positioned within the manifold 404 so that they can be replaced when worn by continuous septum penetration.

The spike 429 has a central fluid channel 431 connected to the central pipe 425 of the compartment 420 (FIG. 17). Further, a fluid channel 433 is formed inside the spike 429, and when the container 402 is sandwiched between the manifolds 404, fluid is communicated with the inside of the compartment 420 via the diffuser 427. Thus, the central fluid channel 431 and the central pipe 425 form a combined fluid channel concentric with the fluid channel provided by the neck of the connector 407. The type of spike 429 shown in FIG. 15 is used to be connected to the first connector 407 a of the sodium bicarbonate compartment 412 and the sodium chloride compartment 414, and the glucose compartment 420, and the fluid input channel 434 and the glucose output channel 436. To form

FIG. 18 shows another spike 429a. In such a configuration of the spike 429a, the central fluid channel 431a is connected to the central pipe 42 of the compartment 418.
5 are directly connected so that the center pipe 425 acts as a vent. This type of spike connects the lactic acid compartment 408, the detergent compartment 410, the calcium chloride compartment 416, and the magnesium chloride compartment 418 to the manifold 404, and further connects to the second connector 407b of the glucose compartment 420. Used to form a glucose vent channel 432.

As shown in FIG. 18, the cap 406 includes a cover 435 that is sandwiched over the spikes 429a when the cap 406 is placed on the manifold 404 for sterilization of the device 100. The cover part 435 directs the flow of the sterilizing fluid discharged from the other fluid channel 433 into the central fluid channel 431a again, and sterilizes the central fluid channel 431a. Without the cover part 435, it is impossible to guide the sterilizing fluid through another fluid channel 433 into the center fluid channel 431a.

FIG. 16 shows the manifold cap 406 removed from the manifold 404. The container 402 is lifted by the container support rails 417 from the position shown in FIG. 15 due to the removal of the cap 406, and the cap 406 cannot be rotated to the position shown in FIG. The cap is mounted on the manifold 404 by a spring-loaded hinge 43.
7 attached. This allows the cap 4 on the manifold 404
Since the last movement of 06 can be guaranteed to be linear rather than curvilinear, lateral wear between the manifold 404 and cap 406 is prevented. A small DC motor (not shown) in hinge 437 provides a driving force to rotate cap 406 at a position above manifold 404. Further, a spring mechanism can be further used.

FIG. 17 shows the container 402 with the cap located on the manifold 404 with the diaphragm 423 ruptured by a spike 429.

FIGS. 24 and 25 show compartments, eg, compartments 408, 41, designed in other patterns. Hereinafter, the compartment 408 will be described. This design is primarily for ventilation channels 424
The arrangement of the fluid channels 426 is different from the design described with reference to FIGS.

The neck of the compartment 408 has an insert 54 with a thin film 545 attached to the top surface.
2 inclusive. The membrane 545 is, for example, an aluminum wheel that is ruptured and penetrated by spikes 429. The center channel of the spike cooperates with the vent channel 424 as in previous designs.

[0256] The first tube 544 is provided integrally with the ventilation channel 424. The first tube can have a circular cross section, but any shape is possible. A second tube 546 having a relatively smaller space than the first tube 544 is disposed inside the first tube 544. At the bottom of the first tube 544, a small space 548 is opened into the compartment 408 through a narrow ring-shaped slit 550. The second tube 546 has a hole 552 at an upper portion thereof that communicates with the inside of the second tube through a small space 548. The second tube 546 has a spike 42 at its bottom.
9 ring channels.

In operation, if the compartment contains powder to be injected, water enters through spikes 429 to the upper inside of second tube 546. Water is drained into small space 548 through hole 552 and flows below ring-shaped slit 550 and is then directed laterally along the bottom of the compartment to properly dissolve the powder in the compartment. Water is second
By flowing slowly down along the outer surface of the tube 546 and along the inner surface of the first tube 544, the small space still maintains the majority air content.

When fluid is drained from the compartment after inflow, a spike in the tube 546 exerts a suction force. The fluid rises inside the small space 548 by the slit 550 and is sucked in the direction of the opening 552. The air in the small space moves downward at the upper part of the second tube 546 and is captured. The fluid fills the remaining portion of the second tube 546. Since the flow inside the second tube 546 is slow, the air remains at the upper portion.

When the compartment is separated from the spike, the fluid inside the second tube 546 is discharged to the manifold 404 side (FIG. 5). The air cushion at the top of the second tube 546 prevents other fluids from passing upwards in the small space 548 so that no other fluids are discharged from the compartment. Therefore, at the time of separation, it is possible to prevent leakage from the cartridge except for the first slight leakage. In such a design, the above-mentioned diaphragm 423 is not required.

FIG. 25 shows a state where the spikes are in the coupling position, and has the same compartment as FIG. Such a design can be used as a lactic acid compartment 408, which is initially liquid, and can be applied to other compartments with powdered components, including a glucose compartment.

Returning to FIG. 5, when the concentrate mixing module 400 operates normally, the heated purified water enters the concentrate mixing module 400 from the heat control and sterilization module 300 through the mixed water supply connection 4a. . The mixing system bypass valve 440 is used to remove purified water from the concentrate mixing module 400 for sterilization of, for example, downstream components.
To be discharged through the mixing module output connection 4b. Water flow in the mixing system can be stopped by a mixed water stop valve 442.

[0262] Downstream of the mixed water stop valve 442, a glucose selection valve 444 is provided.
At 44, the flow of purified water is passed or stopped, thereby passing the glucose solution from the glucose compartment 420 to downstream components of the mixing system. In order to supply water for glucose dissolution to the glucose compartment 420, the mixed water system bypass valve 440 is opened, and the purified water is discharged from the mixed water supply connection portion 4a by using the reverse flow control pump 446. Glucose compartment 420 through glucose select valve 440 via glucose input valve 490 and fluid input channel 434
Is discharged to

The flow control pump 446 is similar in structure to Gambro standard part number K1 4207 002, but is a piston pump having a 9 mm or 12 mm diameter other than the standard 6 mm diameter. Glucose recirculation pump 448, for example a gear pump or centrifugal pump, pumps water through glucose compartment 420 into fluid input channel 43.
4 and through the glucose output channel 436,
Ensure complete dissolution of glucose. During recirculation, the glucose input valve 490 is closed, so that the rest of the mixing module 400 can operate independently while the glucose is dissolved.

Downstream of the glucose selector valve 444, the mixing chamber 450 has a flow from the variable salt input pump 452 that can flow back to the flow of purified water (or glucose solution from the glucose compartment 420) from the mixed water supply connection 4a. (Gambro standard part K1 4207 002).

The flow control pump 446 includes a current meter 454, and the salt input variable pump 452
Also has a current meter 456. The anemometers 454, 456 monitor the volume flow of each pump 446, 452 to confirm proper operation of the pumps. If the discharge operation is performed only under the control of the variable salt input pump 452, the flow control pump 446 is bypassed by the flow control pump bypass valve 458. The variable salt input pump 452 and the flow control pump 446 are volume accurate piston pumps used to control the salt concentration of the PD fluid. Salt input variable pump 452
The maximum flow rate through the flow control pump 446 is controlled to be, for example, 50 ml / min, and the maximum flow rate through the flow control pump 446 is, for example, 180 ml / min.

Downstream of the flow control pump 446, two independent hybrid conductivity meters 46
0 indicates that the formation of the salt solution passing through them is independent of each of the independent hybrid temperature sensors 4.
Monitor with 62. Two conductivity meters 460 and two temperature sensors 462 are provided so that if one meter or sensor fails, the other will operate instead. One of the instruments and one of the temperature sensors communicate with the control system, and the other instruments and sensors communicate with the protection system (see FIG. 1a).

Downstream of the hybrid conductivity meter 460 and the hybrid temperature sensor 462, the drain disinfection valve 464 uses water from the mixed water supply connection 4a to mix the module drain connection 1
Pass through 5. During disinfection, the drain disinfection valve 464 is driven in this manner. At this time, the water entering the mixed water supply connection part 4a is subjected to the heat control and sterilization module 3
00, it is heated at the disinfecting temperature, passes through the next drain disinfecting valve 464 to the drain module 500, and disinfects the drain module 500.

The reservoir fill valve 466 directs the fluid passing through the hybrid conductivity meter 460 to the mixing module output connection 4b or concentrate reservoir 466, where the purified water is concentrated before being diluted with the control fluid. The concentrate reservoir is used to store the fluid. The concentrate reservoir 468 has a reservoir output valve 470 through which the concentrated PD fluid enters the variable salt input pump 452.

In addition, the concentrate reservoir 468 is opened to the manifold cap 406 under the control of the reservoir vent valve 496 to vent while the fill reservoir 468 is being filled and emptied. It has a reservoir vent connection 472 that can be connected to the reservoir. The concentrate reservoir 468 receives the concentrated PD fluid supplied to the patient, and the vent connection 472 of the reservoir is disinfected. To accomplish this and disinfect the spikes 429, during disinfection, the manifold cap 406 descends on the manifold 404 to form a sealed cavity as shown in FIG. Such a cavity can be filled with hot disinfecting fluid from the thermal control and sterilization module 300 via the mixed water supply connection 4a, which will be described in detail below. First, the air contained in the cavity formed by the manifold 404 and the cap 406 enters the drain module 500 via the cap vent valve 474 by the mixing module drain connection part 15. When all air is thus exhausted from the cavity, the cap vent valve 474 provides a connection from the cavity formed by the manifold 404 and the cap 406 to the mixing module drain connection 15 so that disinfecting fluid is circulated through the cavity. Can be In this way, the reservoir vent connection 472 will be completely disinfected if the reservoir vent connection 472 is opened to the atmosphere during operation of the system. The reservoir vent valve 496 is closed during such a process, but the manifold 4
Once the reservoir 04 and the manifold cap 406 have been disinfected, they can be opened to allow disinfecting fluid to pass directly from the reservoir vent connection 472 to the mixing module drain connection 15 to disinfect the reservoir vent valve 496.

The cavity formed by the manifold 404 and the manifold cap 406
After disinfection, the cap vent valve 474 is opened and the manifold cap air vent 6 is opened.
Connects the cavity to the atmosphere, which drains. Next, the disinfecting fluid is supplied to the reservoir drain disinfection valve 498, the reservoir vent valve 496 and the mixing module drain connection 1
5 through the drain module 500. Dissolving and mixing the salt from the compartment of the disposable concentrate container 402 is accomplished by opening and closing valves disposed in the fluid lines 426, 430 of the compartments 408-418, and the variable salt input pump 452 is used to enter the water. Water can be supplied to each compartment 408-418 at a stage, and then the salt solution can be drained from each compartment 408-418.

Each compartment 408-418 of the disposable concentrate container 402 has a respective input valve, ie, lactic acid input valve 478, detergent input valve 480, sodium bicarbonate input valve 482, sodium chloride input valve 484, calcium chloride An input valve 486 and a magnesium chloride input valve 488 are provided. Also, the sodium bicarbonate compartment 412
And the function of the combined vent and fluid channel 428 of the sodium chloride compartment 414 is controlled by a respective sodium bicarbonate vent valve 492 and sodium chloride vent valve 494.

The correct operation of such valves 478-488 is monitored using a salt input pressure sensor 476 as follows. After one of the input valves 478-488 is activated and closed, a signal is transmitted to all input valves 478-488 to close all valves. Next, a current is supplied to the variable salt input pump 452 to discharge water from the mixed water supply connection part 4a toward the input valves 478-488. Salt input variable pump 4
The pressure generated by 52 is monitored by a salt input pressure sensor 476. If one of the input valves 478-488 is locked in the open position, it will not be possible to apply a sufficiently high pressure, and such a fault condition will cause the salt input pressure sensor 4 to fail.
76.

In the above-described first type compartments 408, 410, 416, and 418, the calcium chloride compartment 416 will be described as an example. Water from the mixed water supply connection section 4a is supplied to the mixing chamber by the salt input variable pump 452. It is discharged through 450 and discharged into the calcium chloride compartment 416 through the compartment fluid channel 426 by the calcium chloride input valve 486. All input valves 478-48 in other compartments 408-418
8 is closed. Calcium chloride compartment 4 changed by water discharged into compartment
The air in 16 is vented through vent channel 424.

When the required amount of water passes through the calcium chloride compartment 416 by the variable salt input pump 452, the calcium chloride powder that was in the compartment when the disposable concentrate container was filled is dissolved. become. The weight of calcium chloride in the calcium chloride compartment 416 is preset and the volume of water passed by the variable salt input pump 452 is known so that the concentration of the calcium chloride solution formed in the calcium chloride compartment 416 can be determined. An approximation can be obtained.

The variable pump 452 is driven by a step motor. Each step corresponds to a defined volume of fluid to be dispensed, depending on the rotational position of the stepper motor. The pump motor control system accurately calculates the volume delivered by the pump.

In order to transfer the required amount of the calcium chloride solution to the concentrate storage 468, the flow control pump 446 is driven to discharge water from the mixed water supply connection 4a at a predetermined speed. The water is guided to the mixing module drain connection 15 by a drain disinfection valve 464. The variable salt input pump 452 is driven by the mixing chamber 450 to discharge the calcium chloride solution at a controlled volume flow rate to the mixing module drain connection 15 through the hybrid conductivity meter 460 via the flow control pump 446. Since the flow rate through the mixed water supply connection 4a is constant through the flow control pump 446, the amount corresponding to the flow rate generated from the variable salt input pump 452 is reduced, thereby obtaining a predetermined dilution ratio. Hybrid conductivity meter 460 measures the conductivity and concentration of the diluted calcium chloride solution and adjusts the flow rate of variable salt input pump 452 to achieve a predetermined concentration. When the required concentration is obtained, the reservoir fill valve 464, instead of the drain disinfection valve 464, directs the calcium chloride solution to the concentrate reservoir 468, where calcium chloride is prepared for all components of the concentrated PD fluid. Until it is saved. Accordingly, the amount of calcium chloride present in the concentrate storage can be determined based on the total volume and concentration of the calcium chloride solution passed through the flow control pump 446 to the concentrate storage 468. Hereinafter, the order of salt introduction will be described in detail.

A process similar to the dissolution and measurement of the calcium chloride solution is performed in the magnesium chloride compartment 41.
It is also used to prepare magnesium chloride solution from 8. The cleaning agent is also dissolved in the cleaning agent compartment 410 as needed. Lactic acid is directed undiluted to concentrate store 468. As described below, the solution produced by the cleaning agent is P
Not a component of fluid D.

A solution of sodium bicarbonate and sodium chloride is produced in a different manner than magnesium chloride and calcium chloride, because sodium bicarbonate and sodium chloride are used in larger amounts than magnesium chloride and calcium chloride. Taking the production of sodium bicarbonate as an example, it is as follows. All input valves 478-488 except the sodium bicarbonate input valve 482 are closed. The sodium bicarbonate vent valve 492 is set such that the combined vent and fluid channels 428 of the sodium bicarbonate compartment 412 communicate via the manifold 404. The variable salt input pump 452 provides a 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 acquisition and output channel 430 to control the sodium bicarbonate separation. The liquid is discharged into the chamber 412.
A sufficient amount of water is introduced into the sodium bicarbonate compartment 412, and the sodium bicarbonate powder is completely immersed in the water in the compartment 412.

When the sodium bicarbonate powder is completely immersed inside the sodium bicarbonate compartment 412, the sodium bicarbonate vent valve 492 is connected to the mixed water supply connection part 4a and the combined venting and fluid of the sodium bicarbonate compartment 412 are performed. Channel 428 will be provided with a fluid path. The variable salt input pump 452 is reversed and the nearly saturated sodium bicarbonate solution is drained from the sodium bicarbonate compartment 412 through the combined acquisition and output channel 430 and the sodium bicarbonate input valve 482. The conductivity of the sodium bicarbonate solution becomes controlled, and the solution is diluted and stored in concentrate store 468 in a manner similar to the calcium chloride solution described above.

The mixing and measurement of the sodium chloride solution takes place in such a manner.

The amount of salt inside each compartment 408-418 may be different for each compartment 4 during normal operation.
08-418 is determined to produce a salt solution with a particular conductivity. Thus, if a malfunction of the system occurs and an erroneous salt solution is produced, for example magnesium chloride instead of calcium chloride, this will be identified by conductivity measurements.

In addition, the salts are mixed at a relatively high concentration so as to provide an environment in which bacteria cannot survive. This allows for bacterial control. Also, by making the salt concentration relatively high, the conductivity meter 460 operates within a range where the measurement error is relatively negligible compared to the measured value, and as a result, the accuracy of the concentration measurement is improved. Will be improved.

The dissolution of the glucose solution has already been described. A required amount of glucose solution is supplied by a flow control pump 446 to a glucose input valve 490 and a glucose selection valve 444.
And discharged to a concentrate store 468 via a store fill valve 464. At this time, since the pump used has a large capacity, the measurement of glucose is completed within a short time.

At the end of the dissolution and measurement operation, the concentrate reservoir 468 has the exact salt to glucose ratio required for the patient's individual formula, but has a high absolute concentration of concentrated PD.
Accepts fluid. Therefore, it is preferable to add water to this concentrated PD fluid in order to obtain a PD fluid suitable for the patient's prescription.

If it is desired to provide the PD fluid to the patient through the mixing module output connection 4b, the metered flow rate (approximately 50 ml / min) of the concentrated PD fluid is supplied by the salt input variable pump 452 to the concentrate reservoir 468. Is discharged into the mixing chamber 450 through the storage output valve 470. The flow control pump 446 is bypassed by opening the flow control pump bypass valve 458 and has a constant flow rate (approximately 300 m
1 / min) of the PD fluid is supplied to the thermal control and sterilization module 300 by the positive displacement pump 35
2 discharges from the mixing module output connection 4b (see FIG. 4). The flow from the mixing module output connection 4b is greater than the flow generated by the variable salt input pump 452, and the additional fluid flow (about 250 ml / min) not provided by the variable salt input pump 452 is applied to the mixed water supply connection 4a. Is discharged from Thus, the concentrated PD fluid from concentrate reservoir 468 is diluted in mixing chamber 450 by the water flowing out of mixed water supply connection 4a, and the PD fluid of the desired concentration is mixed via mixing module output connection 4b. It comes out of the concentrate mixing module 400. The PD fluid concentration is monitored by a hybrid conductivity meter 460 and controlled by varying the flow rate with a variable salt input pump 452.

[0286] In this manner, diluting the concentrated PD fluid from the concentrate store 468 is a
Not only does the D fluid's salt and glucose concentration be reduced to the required levels, but it also ensures that the level of gas dissolved in the PD fluid is below the maximum medically required level. The inventor has determined that when the concentrated PD fluid in the concentrate reservoir 468 is ready to be used, the PD fluid should at most be saturated by dissolved gases entering the system as salts and glucose are dissolved. Assumed. However, water entering the concentrate mixing module 400 at the mixed water supply connection 4a is degassed by the water preparation module 200. The dilution ratio between the flow rate of the concentrated diluting fluid discharged by the variable salt input pump 452 and the flow rate of the water entering the mixed water supply connection 4a is such that the concentrated dialysis fluid saturated with gas is reduced to at least a medically required level. Select to have content.

The flow through the RO membrane disinfection connection 3 is controlled by the RO 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 selection valve 444, the mixing chamber 450, and the RO membrane disinfection by the salt input variable pump 452. The water is discharged through the valve 499 to the water preparation module 200 via the RO membrane disinfection connection 3.

When the disposable concentrate container 402 is properly positioned and connected to the spikes 429 in the manifold 404, the operation is performed in the following order.

First, in order to generate a sodium carbonate solution having a concentration of about 2284 mmol / l in the cleaning compartment 410, the cleaning compartment 41 containing 20 g of sodium carbonate was used.
80 ml of water are introduced into the chamber 0, which wets the cleaning compartment 410. Here, the sodium carbonate solution is used for cleaning as described above.

[0290] Peritoneal dialysis fluid consists of six different substances: magnesium chloride, calcium chloride, sodium bicarbonate, sodium chloride, lactate and glucose. The amount of material in each compartment 410-420 is shown in Table 2.

To wet the disposable concentrate container 402, first 962 ml of water is introduced into the glucose compartment 420 by the flow control pump 446. Flow control pump 4
66 can operate at about 180 ml / min, so the introduction of such water is about 5.
It takes 5 minutes. Next, the glucose input valve 490 is closed and the glucose recirculation pump 448 is activated to recirculate glucose inside the glucose compartment 420 to promote complete dissolution.

Next, the magnesium chloride input valve 488 is opened, and 48.4 ml of water is introduced into the magnesium chloride compartment 418. After that, magnesium chloride input valve 4
88 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 about 50
It is performed by a salt input variable pump 452 having a maximum capacity of ml / min. It takes about 4 minutes to perform the two water introduction steps. Magnesium chloride and calcium chloride are completely dissolved by the water introduced during or immediately after the introduction of water into the compartment, so that all the salt particles are finally dissolved.

Next, the sodium hydrogen carbonate input valve 482 is opened, and the salt input variable pump 45 is opened.
2 introduces about 60 ml of water into the sodium bicarbonate compartment 412. Accurate water introduced into the sodium bicarbonate compartment 412 unless the water rises above the combined venting and fluid channel 428 and does not pass below the channel 428 into the manifold 404 via the sodium bicarbonate vent valve 492. The amount of is not important. Even if a very small amount of water passes in such a manner, the exact amount of water is not important.

Next, a similar process proceeds by introducing approximately 100 ml of water into the sodium chloride compartment 414 by means of the variable salt input pump 452. All powder in the sodium bicarbonate compartment 412 and the sodium chloride compartment 414 is not completely dissolved because the amount of water introduced is not sufficient to dissolve all the powder.

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

When the liquid at 25 ° C. was received from each compartment by the above-described water introduction process, the compartments 408-420 contained salt and glucose electrolytes having the following concentrations in the compartments. include. 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.

[0297] The exact order in which water is introduced into the compartment may differ from the order given above.

In the next step, measured amounts of electrolyte and glucose are delivered to the concentrate store 468. The solution in concentrate reservoir 468 is a solution having a concentration about five times that of the final required solution. The concentrate reservoir solution is then diluted 1: 5 before being introduced into the patient's peritoneal cavity and before being sent to OLA 375 for sterilization. Therefore, concentrate reservoir 468 must contain 600 ml of concentrated solution to provide 3000 ml of final peritoneal dialysis solution after dilution.

The first substance introduced into the concentrate reservoir 468 is sodium bicarbonate. A sodium bicarbonate vent valve 492 adjusts the combined vent and fluid channel 428 to be connected to the mixed water supply connection 4a, and a sodium bicarbonate input valve 482 is an input variable pump that opens the combined water inlet and output channel 430. Opened to be connected to 452. By activating the variable salt input pump 452, nearly saturated sodium bicarbonate solution is drained from the bottom of the sodium bicarbonate compartment 412 and water is removed from the water preparation module 200 via the combined venting and fluid channels 428. It is introduced up to the top of the sodium bicarbonate compartment 412. 40m
In order to provide a final sodium bicarbonate solution at a concentration of mol / l, 120 mmol of sodium bicarbonate corresponding to 100 ml discharged by the variable salt input pump 452 must be delivered to the concentrate reservoir 468. Therefore, the variable salt input pump 452 provides a pumping rate of 40 ml / min to provide the required volume.
. Operate for about 5 minutes. At the same time, the flow control pump 446 can obtain a conductivity of approximately 35 mS / cm by adjusting at 60 ml / min to obtain a dilution ratio of 1: 1.5.

As described above, the mixed solution is passed through the drain disinfection valve 464 and the mixing module drain connection unit 15 to the drain module 500 until a stable value is obtained from the hybrid conductivity meter 460. Next, the drain disinfection valve 464 and the reservoir fill valve 466 are switched to communicate the solution to the concentrate reservoir 468.

The conductivity measurement in the hybrid conductivity meter 460 is converted by the control system to the corresponding concentration of sodium bicarbonate and multiplied by the flow rate measured by the flow meter 454 of the flow control pump 446 for 1 minute of hybrid conductivity. The amount of sodium bicarbonate passing through meter 460 is obtained. By integrating such a one minute amount over time, the total amount of material discharged into the concentrate store 468 is obtained. If 120 mmol has been delivered, the reservoir fill valve 466 will stop further introduction into the concentrate reservoir 468 and switch to direct the solution to the drain module 500 via the mixing module drain connection 15. . Accurate amount of ingredients in concentrate store 4
The fact that 68 has been discharged can also be controlled by the flow meter 456 of the variable salt input pump 452, which must discharge 100 ml.

Immediately after switching the reservoir fill valve 466, the variable salt input pump 452 moves in the opposite direction to return the sodium bicarbonate present in the tube between the sodium bicarbonate input valve 482 and the mixing chamber 450. Inverted to dispense clean water, saving material and washing the tubing system with clean water. The volume of most of the saturated sodium bicarbonate thus recovered is relatively small, but can be significant. An air cushion is provided at the top of the compartment 412 so that a corresponding amount of air is conducted into the combined ventilation and fluid channel 428. During the next operation of the compartment, such a volume of air is reintroduced into compartment 412.

[0303] The flow control pump 446 also operates to scrub the sodium bicarbonate in the remainder of the pipe system downstream of the mixing chamber 450.

[0304] Once the peritoneal dialysis fluid generally contains only bicarbonate as a buffer, the final concentration of the buffer can be controlled by adjusting the amount of bicarbonate introduced into the concentrate reservoir 468. By introducing 100 ml, a final sodium hydrogen carbonate concentration of 40 mmol / l can be obtained, and by introducing 87.5 ml, a final sodium hydrogen carbonate concentration of 35 mmol / l can be obtained. pH
Can be adjusted by adding lactic acid.

The final peritoneal dialysis fluid is, for example, 25 mmol / l sodium bicarbonate and 15 m
When mol / l of sodium lactate is contained, the following process is connected.
Mixtures with about 5:35 to 35: 5 or other sums of 40 or more are obtained.

The lactic acid input valve 478 is opened so as to be connected to the variable input pump 452 that opens the lactic acid compartment 408. 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. When 15 mmol / l sodium lactate is required, the variable salt input pump 452 pumps 16 ml of lactic acid (30% concentration) into the concentrate reservoir 468. The concentration of the lactic acid solution can be monitored by a hybrid conductivity meter 460 and will exhibit a conductivity value of approximately 39 mS / cm.

During the introduction of lactic acid into the bicarbonate solution from the concentrate reservoir 468, the acid reacts with bicarbonate ions to form carbon dioxide, which is connected to the reservoir vent connection 472, the reservoir vent. Ventilated through valve 496 and cap vent valve 474. Concentrate storage 46
At the top of 8, a carbon dioxide cushion is formed and communicated to the surrounding atmosphere. Thus, the carbon dioxide partial pressure is 1 atmosphere (1 bar), which results in a dissolved carbon dioxide concentration of about 23 mmol / l at equilibrium of the liquid in the concentrate reservoir. Although the rate of carbon dioxide formation is relatively fast, a brief pause is required until the end of carbon dioxide evolution.

[0308] Once again, the salt input variable pump 452 will operate until the water reaches the lactic acid input valve 478.
Or until just before, the tubing system is flushed with water from flow control pump 446, reversed to return lactic acid into lactic acid compartment 408.

Next, sodium chloride is introduced into concentrate store 468. 140 mmol
In order to provide a final solution of / l, 470 mmol must be transferred to the concentrate reservoir 468, which corresponds to 80 ml of the concentrated solution. Since sodium chloride has a very high conductivity, it is preferable to dilute it as much as possible inside the mixing chamber 450. However, the dilution ratio will not be too high due to the final volume limitation in concentrate store 468. For example, the dilution ratio will be less than 1: 4. Therefore, the flow control pump 446 is adjusted at 40 ml / min, and the variable salt input pump 452 is adjusted at 160 ml / min to about 98 mS / cm.
Is obtained. A similar integration method as described above for sodium bicarbonate is applied to determine if a sufficient amount of sodium chloride has been introduced into concentrate store 468. This is determined when the variable salt input pump 452 has discharged 80 ml after about 2 minutes.

Further, the salt input variable pump 452 transfers the sodium chloride solution to the sodium chloride compartment 41.
4 and is reversed to return the glean air into the combined venting and fluid channel 428.

Next, the glucose input valve 490 is opened to communicate glucose to the concentrate store 468. For example, to obtain a final crew course concentration of 1.5%, 75
125 ml of glucose solution is 4 ml to obtain a final concentration of 2.5%.
. 200 ml must be transmitted to obtain a final concentration of 0%. To save time, the flow control pump 446 is used for such a purpose. Glucose has no intrinsic conductivity that can be measured by the hybrid conductivity meter 460. If the accurately measured volume is introduced by the flow meter 454, the glucose selector valve 444 will switch water from the mixed water supply connection 4a to flush the tubing system.
It operates to be transmitted via. If necessary, the flow control pump 446
Can be reversed while the mixing system bypass valve 440 is first opened to return glucose to the glucose compartment 420 as described above. Since the recovered volume is smaller than the volume in the glucose compartment, recovery for glucose need not be performed.

[0312] The dilution ratio of sodium chloride is selected according to the desired glucose concentration so that the volume obtained up to now in the concentrate reservoir 468 is approximately 570 ml.

Finally, magnesium and calcium are introduced into concentrate reservoir 468.
Such substances are introduced as late as possible after dilution at the bottom concentration in order to avoid the problem of bicarbonate precipitation.

First, the magnesium chloride input valve 488 is opened, and the variable salt input pump 452 is operated, so that magnesium chloride is introduced into the concentrate storage 468. Corresponds to 0.6 ml, but 1.5 mmol of magnesium chloride is 0.5 mm
Must be delivered by the salt input variable pump 452 to obtain a final concentration of ol / l. The variable salt input pump 452 is sufficiently accurate that small amounts can be accurately metered. The pump is controlled at 1/100 revolution with a displacement of 228 μl per revolution.

[0315] Magnesium chloride is not introduced in concentrated form into concentrate reservoir 468 to avoid localized precipitation. Therefore, the flow control pump 446 is 1:10
Operating at 10 times the speed of the salt input variable pump 452 to obtain a dilution ratio of The conductivity of the magnesium chloride solution amounts to about 35 mS / cm. The discharge rate is obtained by multiplying the conductivity value by the flow rate obtained from the flow control pump 446 and integrating the concentration obtained from the hybrid conductivity meter 460. The discharge volume is checked with a salt input variable pump 452 which must discharge 0.6 ml. Concentrate storage 4
After completion of the introduction into 68, the variable salt input pump 452 is reversed to return the magnesium chloride into the magnesium chloride compartment 418. Such a process is important for magnesium chloride and calcium chloride provided in small amounts.

Finally, a similar process applies to calcium chloride. 1.5 mmol
4.5 mmol, corresponding to 2.1 ml of concentrated solution, must be transferred to the concentrate store 468 to provide a final calcium solution of / l. For magnesium, such a process is performed at a dilution ratio of 1:10. Conductivity is about 34m
S / cm.

When calcium ions are mixed with bicarbonate ions, there is always a risk of calcium carbonate precipitation. An air cushion containing carbon dioxide is provided on top of the concentrate reservoir 468 to provide a saturated carbon dioxide gas content in the solution and to prevent precipitation by lowering the pH of the solution as much as possible. .

Before mixing with calcium chloride, to ensure as high a carbon dioxide content as possible, lactic acid is introduced as late as possible in the mixing process, ie immediately before the addition of magnesium chloride and calcium chloride, to reduce carbon dioxide evolution and Achieve complete solution saturation with carbon dioxide. The order of sodium bicarbonate, sodium chloride, and glucose can be different from the order described above, for example, first sodium chloride, then glucose, and then sodium bicarbonate.

After the production of the concentrated PD solution in the concentrate reservoir 468, the PD solution is diluted 1: 5. In this mode of operation, the OLA pump 352 has a 300 ml /
min. and the salt input variable pump 452 is adjusted to 60: 1 to obtain a dilution ratio of 1: 5.
It is operated at ml / min.

The mixed conductivity meter 460 adjusts the salt input variable pump 452 to control the concentration of the mixed solution to avoid changes in conductivity.

FIG. 5a shows a slightly modified mixing section. A metering pump 448a is inserted in the pipe between the glucose input valve 490 and the glucose selection valve 444. Metering pump 446a is bypassed by valve 490a. The glucose selector valve 444 replaces a direct connection to the mixing chamber 450. Such additional components allow for glucose concentration measurements in glucose compartment 420. The operation is as follows.

The concentration of glucose after water is introduced into glucose compartment 420 and glucose is dissolved is about 50%. However, there is always a risk of error, and it has been required to control the glucose concentration.

To start such a glucose check process, the sodium chloride input valve 484 and the sodium chloride vent valve 494 are opened, the salt input variable pump 452 is operated, and the flow control pump 446 is set to about 500 mmol / l, ie, About 1:10
Operated to provide a sodium chloride solution having a dilution ratio of Hybrid conductivity meter 460 must measure approximately 46.7 mS / cm. The flow control pump 446 is operated at approximately 50 ml / min, and the salt input variable pump 452 is approximately 5 ml / min.
/ Min. Next, the glucose input valve 490 is opened, the metering pump 448a is operated, and the glucose solution is discharged from the glucose compartment 420 to the mixing chamber 450 via the fluid input channel 434, the glucose input valve 490, and the metering pump 448a. The metering pump 448a is driven at, for example, 20 ml / min.

Introducing glucose into the sodium chloride solution in mixing chamber 450 causes a decrease in conductivity as measured by hybrid conductivity meter 460. This reduction is actually proportional to the glucose solution concentration. Thus, the glucose concentration can be monitored in the glucose compartment 420.

After measuring the glucose concentration, the above-described process is performed.

Also, as described in connection with FIG. 5 a, the resulting mixture, ie, a mixture of glucose and sodium chloride, is passed to concentrate store 468. In this case,
The variable sodium salt input pump 452 must be operated at high speed so that the amount of water introduced into the concentrate store 468 is not too high.

A similar operation can be achieved by using a glucose recirculation pump 448 as a reversible measurement pump instead of the individual measurement pump 448a.

Lactic acid is used to monitor the drop in conductivity, and the lactic acid can be diluted with glucose. In such a case, no additional pump is required as compared with FIG. During operation, the lactic acid input valve 478 is opened, the salt input variable pump 452 is adjusted at 10 ml / min, the flow control pump 446 is adjusted at 15 ml / min, and the glucose selection valve 444 and the mixed water stop valve 442 are opened to 5 ml. / M
in is passed into the mixing chamber 450 from the mixed water supply connection 4a. Next, the conductivity is measured. Next, the glucose input valve 490 is opened, and the glucose selection valve 444 is switched to supply water to the mixing chamber 450 (5 ml / m2).
in) turns into a supply of glucose. When the decrease in conductivity is monitored,
A calculation is made to determine the corresponding concentration of glucose.

FIG. 5 a shows an arrangement in which an electric heater 438 a is arranged in a fluid input channel 434 connected to a glucose compartment 420. The electric heater is used to heat the glucose solution recycled during the dissolution process to promote dissolution. Glucose cools during dissolution, so it must be heated to maintain a temperature of 40 ° C. during the entire dissolution step.

FIGS. 5b and 4a show another design of the glucose measurement phase. Referring to FIG. 5b, metering pump 448a has been replaced with a reversible metering pump 448b. The metering pump 448b is configured to be able to discharge the glucose solution for a back pressure applied to 3 bars or more, preferably 6 bars or more. The reason will be described below. Valve 490a bypasses pump 448b. A glucose input valve 490b is disposed between the mixing chamber 450 and the input tube 434 to wet glucose in the compartment 420.

The operation of the modified device according to FIG. 5b is the same as described above in connection with FIG. 5 or FIG. 5a, except that no glucose enters the concentrate store 468. Instead, the concentrated glucose is metered by a metering pump 448b and through an open valve 490b to an output connection 4c leading to an input connection located in the middle of the OLA sterilizer as shown in FIG. 4a. Reportedly.

In the modified OLA sterilizer shown in FIG. 4a, the oil tanks 364-368 are replaced with electric heaters 364a. Inlet 4b, valve 356 and heat exchangers 360, 362
The incoming fluid entering the OLA device via is an electrolytic fluid having components that are not heat sensitive. Thus, although the electric heater has a hot portion, the electrolytic fluid can be heated by the electric heater without the risk of decomposing or forming harmful substances. The heat-sensitive solution of the final solution, glucose, enters at the inlet 4c from behind the electric heater 364a. In this position, the electrolytic fluid is at a high temperature, for example, 150 ° C. and a high pressure, for example, 6 bar absolute. The incoming fluid rapidly heats the concentrated glucose solution at an elevated temperature, for example, 148 ° C. The combined fluid is maintained at an elevated temperature within the coil 363 for a predetermined time determined based on the distance of the flow. Next, the combined fluid is rapidly cooled in heat exchangers 362, 360. The temperature is monitored by the temperature sensor 370. With this operation, thermosensitive glucose is generally 2
It is heated according to the next temperature curve. This is beneficial for sterilization and also for preventing the formation of glucose degrading products. The glucose moiety can be very carefully controlled so as not to overkill the glucose. It is not beneficial to slightly over-sterilize the electrolytic fluid.

Injecting calcium and magnesium ions into the glucose fluid introduced slowly in the OLA device of FIG. 4a to avoid problems with calcium carbonate precipitation and scaling of the tube section in the mixing device shown in FIG. 5b. Can be. In such an embodiment, the calcium chloride and magnesium chloride are dissolved after glucose dissolution and prior to delivery to the glucose output connection 4b.
Informed to 0. Valve 486 is opened and pump 452 is activated to drain calcium chloride from compartment 424. Valve 442 and valve 458 are closed and pump 44
The operation of 6 stops. Valve 490b is placed in the position shown in FIG. 5b and valve 490a is opened. The calcium chloride fluid metered by pump 452 must pass through mixing chamber 450 and valves 490b, 490a to glucose compartment 420. The amount of calcium chloride delivered to glucose compartment 420 is carefully monitored based on metering pump 452. A similar operation is performed for magnesium chloride.

[0334] Finally, the mixed glucose, calcium chloride and magnesium chloride are provided to output 4c for inclusion in the final PD fluid. With such a device, the risk of precipitation is minimized because sodium bicarbonate and calcium chloride do not mix before being introduced into the diluted PD fluid.

[0335] Calcium chloride is supplied to the mixing chamber 450 by the metering pump 452. The flow control pump 446 is activated to dilute the calcium chloride and the fluid is measured by the conductivity meter 460. The measured and diluted calcium chloride is then communicated to the glucose chamber via valve 464a, shown in phantom in FIG. 5b. The same operation is performed for magnesium chloride.

On the other hand, in combination therewith (part of) calcium chloride and / or magnesium chloride can be delivered to the concentrate store 468 as already described.

Drain Module 500 FIG. 6 shows the drain module 500 in detail. The fluid supplied to the drain module 500 by the peripheral pressure discharge connection portion 14b and the mixing module drain connection portion 15 is directly guided to the heat recovery drain connection portion 13b, where it is heated before being recovered by the heat recovery drain return connection portion 13c. Heat control and sterilization module 30 for recovery
Pass through zero. The fluid entering the heat recovery drain return connection 13c is passed through the heat recovery return valve 532 to the external waste connection 16. Heat recovery drain connection part 13
The temperature of the fluid exiting b is monitored by a drain disinfection temperature sensor 530.

The water from the heat discharge connection 13a discharged from the purified waste connection 2d of the water preparation module 200 is directly passed to the external drain connection 16 through the heat discharge connection valve 520.

The water from the negative pressure drain connection part 14a passes through the pressure control chamber 510 under the negative pressure generated by the drain pump 508, and then flows to the drain disinfection temperature sensor 530.
Through to the heat recovery drain connection portion 13b. The pressure adjustment chamber 510 includes:
In the form of a chamber closed by a movable spring-loaded diaphragm, pressure fluctuations caused by the drain pump 508 are prevented from being transmitted to the patient along the negative pressure drain connection portion 14a, and the drain process is more easily controlled. Provided.
The drain pump is a pump that generates a predetermined maximum pressure, such as an interlocking pump or a gear pump, or a centrifugal pump.

The control chamber 510 also ensures that the patient does not have a large negative pressure. For this purpose, the adjustment chamber 510 includes a limit switch 512 for monitoring the position of the spring loaded piston 516 inside the chamber 510.
514. The switch may be used during the patient's drain to control a drain pump 508 that provides a negative pressure adapted to the patient's safe condition, e.g., so as not to exceed a negative pressure of 1 m water column relative to atmospheric pressure. it can.

For disinfection, the high temperature disinfecting fluid is supplied to the drain module 50 via the mixing module drain connection 15, the negative pressure drain connection 14a and the peripheral pressure discharge connection 14b.
Enter 0. The disinfecting fluid passes from the drain module 500 along the heat recovery drain connection 13b to the heat control and sterilization module 300 via the drain disinfection temperature sensor 530. Heat is recovered from the disinfecting fluid in the heat control and sterilization module 300, the fluid passes through the heat recovery return valve 532 to the external waste connection 16 and then through the heat recovery drain return connection 13c to the drain module 500. Return to. Chemical disinfectant (or hot water in case of thermal disinfection)
From 00, the heat enters the drain module 500 via the heat discharge connection 13a and passes directly to the external drain connection 16.

Cycler and Sterilizable Connector Module 600 FIG. 7 shows the cycler and sterilizable connector module 600 in greater detail.
In normal operation, the sterile PD fluid is provided to the cycler and the sterilizable connector module 600 via the sterile fluid connection 8a and passes through the patient fill valve 602 to the dialysis line sterilizable connector 604. Sterilizable connector 6
No. 04 is international patent publication WO 96/05883 (Gamb
ro AB).

The operation of the sterilizable connector 604 is schematically illustrated in FIGS. 19a to 19d. Referring to FIG. 19 a, a sterilizable connector 604 is disposed in two corresponding chambers 632 to receive a double male connector 630 at the end of the disposable fluid line 10. The end of each branch of the male connector 630 is closed by a pierceable membrane 634. This membrane 634 is penetrated by each membrane spike 636 when the male connector 630 is fully inserted into the chamber 632 as shown in FIG. 19c. The thin film spikes 636 have channels formed through them, for fluid flow in the direction of the arrows in FIGS. 19b and 19c. The chamber 632 is opened and closed by a connector valve 640 and communicates with a fluid path 638. In another embodiment, there is no connector valve 640 as shown in FIG. 19b. First, the male connector 630 is partially inserted into the chamber 632 as shown in FIG. 19b. By opening the connector valve 640, water at the sterilization temperature and pressure (3 bar) is exposed to the thin film spikes 636 and chamber 632
19b through the fluid path 638. The circulation of the sterilizing water sterilizes the chamber 632, the thin film 634, and the thin film spikes 636.
After completion of such a disinfection operation, the male connector 630 is fully inserted into the chamber 632, thereby penetrating the membrane 634 and opening the fluid path through the membrane spike to the interior of the disposable dialysis line 10. At the same time, the fluid connection between chamber 632 and fluid path 638 and the area around the spike is closed by male connector 630. The fluid, eg, the PD fluid, can then flow in the direction of the arrow shown in FIG. 19c during irrigation or while filling or draining the patient's abdominal cavity.

At the end of the processing session, the flow of PD fluid into the sterilizable connector 604 is stopped, the connector valve 640 is closed and the male connector 630 is partially retracted from the chamber 632, so that air is The disposable fluid line 10 can be entered through a recess 642 formed in the inner wall of the chamber 632. Next, the residual fluid inside the disposable fluid line 10 can be pumped out to drain the disposable dialysis line 10 as indicated by the arrow in FIG. 19d.

Referring to FIG. 7, PD fluid from the sterilizable connector 604 passes from the patient filling connection 9a through the disposable fluid line 10 to the patient's abdominal cavity. A mutually openable patient pinch valve 624 is provided on the patient filling connection 9a and the patient drain connection 9b to tighten the disposable fluid line 10 between two normally closed mouths (not shown). This allows the device to physically stop the flow of the PD fluid in an emergency. The pinch valve 624 is opened only by the control and protection systems when it is safe to operate the device properly and it is safe to deliver the PD fluid to the patient. The pinch valve is also opened during insertion of the disposable line set before use.

FIG. 20 shows a disposable fluid line 10 that connects to a sterilizable connector 604. Two separate tubes 644 extend from male connector 630 to Y-connector 646. Y-connector 646 connects two pipes 644 to a standard catheter connector 654 via passive pinch valve 648. The catheter connector 654 is the only patient connection in the overall device 100 that is not machine sterilized. Conversely, conventional PD processing systems include multiple aseptic connections that can cause peritonitis by introducing potentially harmful bacteria into the peritoneal cavity. The risk of peritonitis was significantly reduced because the device included one sterile connection.
A single aseptic connection is achieved by a sterile connection, for example, a sterile welding device that cuts the end of the line set 10 and the patient tube section with a hot wafer and immediately joins the hot end to form a sterile connection. Can be replaced with a connecting part. The patient tube is partially consumed. They need to be replaced at regular intervals. Such techniques are well known and frequently used. Another connection technique required for sterilization is a connection that is sterilized with ultraviolet light during the connection cycle.

The distance between the Y-connector 646 and the catheter connector 654 is kept as small as possible so that the wasted space inside the disposable fluid line 10 is less than 2 ml. The pressure drop across the disposable fluid line 10 is 3
It is less than 40 mbar (4 kPa) at a flow rate of 00 ml / min.

FIG. 21 shows a disposable dialysis line 10a according to another embodiment. This is used when collecting a sample of the patient's dialysate. Disposable sampling dialysis line 10a includes, in addition to the features of ordinary disposable dialysis line 10, a syringe 652 that is clamped by a drive mechanism (not shown) of sampling module 700. Syringe 65
2 discharges the drained 15 ml of dialysate. As the dialysate mixes in the body, sampling is performed during the drain cycle and represents the average of all processing sessions. Next, the filled syringe 652 is disconnected from the disposable sampling dialysis line 10a by a porcelain sealed fragile connection (not shown) and sent for analysis. If necessary, the syringe can be visually inspected to check the clarity of the dialysate.

Referring again to FIG. 7, the fluid drained when it is desirable to empty the patient's abdominal cavity is:
The disposable fluid line 10 is discharged to the outside through the patient drain connection portion 9b, the sterilizable connector 604, and the patient drain shutoff valve 606 in this order. Fluid drained from the patient drain shutoff valve 606 is monitored through the first patient drain valve 608 and through the negative pressure drain connection 14a so that the negative pressure applied to the patient's abdominal cavity is not harmful to the patient. Pass through two independent patient drain pressure sensors 610. Downstream of the patient drain pressure sensor 610, an output volume flow meter 650 measures the volume of fluid removed from the patient's abdominal cavity and the second patient drain valve 612 shuts off the negative pressure drain connection 14a.
0 provided downstream.

The sterilization bypass valve 614 allows the fluid path to be opened from the sterilization fluid connection 8a to the negative pressure drain connection 14a when the patient bypass valve 616 is opened, without passing the patient. PD fluid can be directed directly to the peripheral pressure drainage connection 14b without opening the patient by opening the germicidal heat recovery bypass valve 618 downstream of the patient bypass valve 616.

During filling of the patient, the pressure of the PD fluid entering the abdominal cavity is reduced by the patient bypass valve 616,
Monitoring is performed by closing the sterile bypass valve 614 and the second patient drain valve 612 and opening the first patient drain valve 608 and the patient drain shutoff valve 606. In this way, since the second patient drain valve 612 is closed, the pressure in the patient's peritoneal cavity can be increased even if there is no flow following the following fluid path.
From the Y-connector 646 to the patient drain pressure sensor 610 via the patient pinch valve 624, the patient drain shutoff valve 606, and the first patient drain valve 608. Such an arrangement allows the patient drain pressure sensor 610 to accurately measure the pressure of fluid entering the patient's abdominal cavity while filling the patient's abdominal cavity,
This allows pressure measurements to be taken as close as possible to the abdominal cavity.

When the positive pressure is too large, that is, when the pressure of the water injection is 2 m higher than the atmospheric pressure and a part of the filling fluid is replaced with waste, the pressure sensor 610 starts operating (and the valve 612 is opened). Then, the drain pump 508 can be controlled.

A pressure regulation chamber 660, similar to pressure regulation chamber 510, can be provided behind patient fill valve 602, as shown by the dashed line in FIG. The operation of chamber 660 is similar to that described for chamber 510.

In addition, with the germicidal heat recovery bypass valve 618 closed, the patient drain shutoff valve 6
06 can be closed and the patient bypass valve 616 and the sterilization bypass valve 614 can be opened. In this manner, a pressure tap is formed from the sterile fluid connection 8a to the patient drain pressure sensor 610, and the patient drain pressure sensor 610 reduces the pressure of the fluid entering the patient's abdominal cavity along the sterile fluid connection 8a. Can be measured.

By monitoring the pressure in the abdominal cavity, the patient can be placed in the disposable dialysis line 1
The control system can detect whether 0 has been blocked or isolated.

During the sterilization of the sterilizable connector 604, the high temperature sterilizing fluid enters the cycler and sterilizable connector module 600 through the sterilizing fluid connection 8a under pressure and enters the patient fluid valve 602, the sterilizable connector 604, and Sterilization bypass valve 61
4 to the sterilization output connection portion 8b. The first patient drain valve 608 prevents disinfecting fluid that is damaging at sterilization temperature during disinfection from reaching the pressure volume flow meter 650, and the patient drain pressure sensor 610 stops water from boiling at sterilization temperature. It is closed to prevent it from receiving the high pressure required for its operation. Flow meters and pressure sensors that can withstand sterilization pressure and temperature with the required accuracy of function are expensive. Thus, providing the first patient drain valve 608 reduces the cost of the device 100.

The heat from the sterilizing fluid is recovered in the thermal control and sterilizing module 300, and the cooled fluid is returned to the cycler and the sterilizable connector module 600 through the sterilizing fluid return connection 8c. The fluid passes through the germicidal pressure release valve 620 to the peripheral pressure discharge connection 14 b and is returned at ambient pressure through the germicidal return shutoff valve 622.

In the second sterilization path, the patient filling valve 602 is closed, the patient bypass valve 616 is opened, and high-temperature and high-pressure sterilization fluid flows from the sterilization fluid connection 8a to the sterilization output connection 8b via the patient bypass valve 616. Can pass children.

For disinfection, the disinfecting temperature fluid is passed through the cycler and the fluid line of the sterilizable connector module 600 and is not sterilized by passing through the negative pressure drain connection 14a and the peripheral pressure discharge connection 14b. Sterilize elements.

Operation of the Device The overall operation of the device 100 is described below. In the initial state of all valves,
Most valves are closed. Therefore, in the initial operation mode, the inflow valve 202 of the water preparation module 200 and the thermal drain connection valve 520 of the drain module 500
And, the heat recovery return valve 532 is closed like the patient pinch valve 624 of the connector module 600 capable of sterilizing the cycler. Therefore, in such a state, the device is shut off from the external environment.

Initially, the disposable concentrate container 402 is not connected to the manifold 404, but the disposable fluid line 10 (without damage to the membrane 634) is partially inserted into the sterilizable connector 604. All pumps and heaters of the device do not operate initially, and the patient output heat exchanger 314 initially drains water.

Disinfection of the Device The first stage of operation is the disinfection of the entire fluid circuit initiated by the water preparation module 200. For disinfection, the inlet valve 202 is opened to allow water to flow into the isolator 208. Isolator vent valve 209 is opened to allow air to escape from isolator 208 to atmosphere through isolator vent 17. The disinfectant selection valve 256 is positioned to direct waste flow from the second RO membrane unit 252 through the disinfectant cartridge 210 and through the open disinfectant valve 212. The degassing pump 222 operates to drain fluid through the disinfectant cartridge 210 or to drain fluid from the isolator 208 if there is insufficient fluid available from the fluid path through the disinfectant cartridge 210. . Disinfectant cartridge 210 (or isolator 208)
) Passes through the cooling water outlet 2a to the heat control and sterilization module 300 and is preheated by the water heater 322 before returning to the water preparation module 200 via the cooling water return connection 2b. The fluid then passes through degassing elements 214-224 where degassing of the fluid takes place.

The RO pump 236 operates to discharge the fluid from the degassing chamber 224 and pass the fluid through the first RO membrane unit 238. The first RO membrane bypass valve 250 is opened and the waste fluid from the first RO membrane unit 238 is re-directed to the output side of the first RO membrane so as to maintain the fluid path. First RO membrane unit 23
All fluid from 8 does not pass through the purified waste connection 2d because the flow path through this connection is stopped by the hot drain connection valve 520 in the drain module 500. The disinfecting fluid from the output side of the first RO membrane unit 238 is R
Recirculated to the disinfectant selection valve 256 via the O pressure relief valve 260 and through the second RO membrane unit 252. Therefore, water is disinfectant cartridge 21
A first disinfecting loop is provided that is circulated to dilute the disinfectant through the zero and the diluted disinfectant is circulated through most of the water preparation module 200. The pumps in the heat control and sterilization module 300, the concentrate mixing module 400 or the drain module 500 are not activated during the initial disinfection of the water preparation module 200. Therefore, since there is no component for discharging the fluid from the purified water connection portion 2c, a negligible amount of fluid does not cross the second RO membrane unit 252, and the pressure difference across the thin film unit 252 is reduced. Because it is not given. The fluid traversing the second RO membrane unit 252 includes purified water connection 2c, mixed water supply connection 4a, mixing system bypass valve 440, mixing module output connection 4b, O
LA input valve 356, germicidal fluid connection 8a, patient bypass valve 616, germicidal heat recovery bypass valve 618, peripheral pressure discharge connection 14b, heat recovery drain connection 13b, heat recovery drain return connection 13c, and released heat. It is conveyed to the external drain connection part via the recovery return valve 532. This water is supplied to the particle filter 204 and the water softener 20.
After 6 the water is replaced by water from the raw water inlet 1.

During the first phase of disinfection for the water preparation module 200, the vent valve 320 in the thermal control and sterilization module 300 is opened and the patient output heat exchanger pump 316 is activated to fill the patient output heat exchanger with the disinfectant. Then, the disinfectant is supplied to the recirculation limiter 31.
Recirculate through zero.

By completely closing the proportioning valve 214 with the deaeration bypass valve 226 closed, the flow through the cooling water return connection portion 2b is stopped. The patient output heat exchanger pump 316 then passes through a vent valve 320 opened from the cooling water outlet 2a to disinfect the patient output heat exchanger vent connection 2e, through the patient output heat exchanger vent connection 2e, It is used to discharge the disinfectant into the isolator 208. The vent valve 209 of the isolator is closed during such a process. Isolator 2
08 from the water preparation module 20 to close this disinfection circulation loop.
The process proceeds to the cooling water outlet 2a of 0.

[0366] The patient output heat exchanger drain valve 318 is opened and the patient output heat exchanger pump 31
When the fluid is circulating between the cooling water outlet 2a and the cooling water return connection 2b when the pump 6 is not operating, the patient output heat exchanger 314 disinfects by sequentially opening the vent valve 209 and the vent valve 320 of the isolator. Can drain the agent.

The air passage between the degassing chamber 224 and the isolator 208 is connected to the vent valve 2 of the isolator.
09 is closed and the deaeration bypass valve 226 is opened to perform disinfection.
Then, the degassing pump 222 guides only the flow from the degassing chamber 224 to the separator 208 via the air passage with the RO pump 236 turned off.

At the end of the disinfection process, the disinfectant selection valve 256 is returned to the initial position with the first RO membrane bypass valve 250 still open. The disinfectant is circulated by the RO pump 236 through the first RO membrane unit 238 and the second RO membrane unit 252, and returns to around the RO pump 236 via the second RO output restrictor 254 and the disinfectant selection valve 256. After such circulation, the first RO membrane bypass valve 250 is closed and the heat drain connection valve 520 in the drain module 500 is opened, so that the disinfectant flows to the heat discharge connection 13a via the purified waste connection 2d. As a result, it can flow out of the external drain connection portion 16.

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

It can be seen that the water preparation module 200 including the water softener 206 to the second RO membrane unit 252 is chemically disinfected by the above process.

[0372] Downstream of the second RO membrane unit 252, the water at the disinfecting temperature supplied from the RO membrane disinfecting connection 3 is used to disinfect the fluid path between the second RO membrane unit 252 and the purified water connection 2c. . In this case, the water from the raw water connection 1 passes through the water preparation module 200 along the normal purification fluid path, and RO water is generated at the output side of the second RO membrane unit 252. The mixed water stop valve 442 of the concentrate mixing module 400 is opened, and the variable salt input pump 452 discharges water from the mixed water supply connection 4a by supplying current. The water supplied to the mixed water supply connection part 4a of the mixing module 400 is discharged from the purified water connection part 2c of the water preparation module 200, and is heated at the disinfecting temperature by the disinfecting heater 330. The salt input variable pump 452 is connected to the second RO through the RO membrane disinfecting connection 3 by the RO membrane disinfecting valve 499 with the water at the disinfecting temperature opened.
The liquid is discharged to the output side of the membrane unit 252. Thus, a closed circulation loop of water at the disinfection temperature is provided, the temperature of which is monitored by the second RO temperature sensor 264.

The disinfection heat exchanger bypass valve 328 is disinfected as part of a thermal disinfection loop by opening the valve to allow hot disinfection water to pass.

The high-temperature water is supplied to the drain module 500 by stopping the salt input variable pump 452 and driving the flow control pump 446 in order to discharge the high-temperature water to the drain module 500 via the mixing module drain connection unit 15. Flows.

Before the disposable concentrate container 402 is connected to the manifold 404, the manifold 404 and cap 406 are heat disinfected. To accomplish this, cap 406 is located on manifold 404 to form a sealed cavity. The flow control pump 446 is driven to discharge the water heated at the disinfecting temperature by the disinfecting heater 330 from the mixed water supply connection 4a. The flow control pump 446 supplies disinfecting water,
Discharge into concentrate reservoir 468 via reservoir fill valve 466. The hot disinfecting fluid is discharged into the cavity formed by the manifold 404 and the cap 406 sequentially through each of the reservoir draining disinfection valve 498, the reservoir output valve 470, and the salt input valves 478-488. The cap vent valve 474 allows air to flow through the manifold 404 and the cap 4.
06 to the drain module 500 through the mixing module drain connection 15 from the cavity formed. When the manifold 404 and cap 406 are filled with the hot disinfecting fluid, the fluid is conveyed to the drain module 500 via the cap vent valve 474 by the mixing module drain connection 15.

In the drain module 500, the high temperature fluid is supplied to the heat recovery drain connection portion 13b.
From the disinfection heat exchanger 326. However, since the disinfecting heat exchanger bypass valve 328 is opened and there is no heat loss from the disinfecting fluid passing through the disinfecting heat exchanger 326, heat returns to the drain module 500 via the heat recovery drain return connection 13c. In this manner, the heat recovery drain connecting portion 13b and the heat recovery return valve 532 are heat-disinfected.

To disinfect the sodium bicarbonate vent valve 492, water at the disinfecting temperature is drained by the variable salt input pump 452 from the thermal control and sterilization module 300 via the mixed water supply connection 4a. At this time, the fluid path formed and filled by the manifold 404 and the cap 406 and opened into the cavity passes only through the sodium hydrogen carbonate vent valve 492 and the sodium hydrogen carbonate input valve 482. Therefore, when the variable salt input pump 452 discharges high-temperature water from the cavity formed by the manifold 404 and the cap 406 through the sodium hydrogen carbonate input valve 482, the high-temperature water flows through the mixed water supply connection portion 4a to pass sodium hydrogen carbonate Alternated via valve 492. The sodium bicarbonate vent valve 492 is switched to disinfect the vent and fluid channel 428. Hot water is recirculated through such a loop by closing the heat recovery return valve 532 in the drain module 500 and opening the mixed water stop valve 442. The same method can be used to disinfect the sodium chloride vent valve 494 and the sodium chloride input valve 484.

The fluid path to the disposable glucose compartment 420 uses a flow control pump 446 to control hot water from the heat control and sterilization module 300 via the mixed water supply connection 4a, the mixing system bypass valve 440, and the glucose selector valve. It is disinfected by discharging into the cavity formed by manifold 404 and cap 406 via 444 and glucose input valve 490. Next, while the flow control pump 446 remains off, the glucose recirculation pump 448 removes the hot water from the glucose input channel 436.
And recirculated through the fluid input channel 434. The glucose input valve 490 is closed at this stage. Finally, the hot disinfecting fluid can exit the cavity formed by the manifold 404 and the cap 406 via the cap vent valve 474 and the mixing module drain connection 15.

After disinfection, the manifold 404 and cap 406 are connected to the atmosphere through the air vent 6 by the cap vent valve 474 and the reservoir formed from the manifold 404 and cap 406 using the variable salt input pump 452. Water is drained by discharge through a drain valve 498, concentrate reservoir 468, and reservoir output valve 470. The variable salt input pump 452 discharges 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.

In order to disinfect the heat control and sterilization module 300 and the cycler and sterilizable connector module 600, high-temperature water is supplied from the disinfecting heater 330 by the positive displacement pump 352 to the mixed water supply connection 4a, the mixing system bypass valve 440 and Discharge is via the OLA input valve 356 via the mixing module output connection 4b. In another route, the disinfecting fluid is discharged through the OLA sterilization valve 376. The disinfecting fluid is passed through the thermal control and disinfection module 300 to the disinfection fluid connection 8a and to the next patient filling valve 6.
02 and the fluid path 6 through the chamber 632 of the sterilizable connector 604.
40, through the patient drain shutoff valve 606, the germicidal bypass valve 614, and the germicidal heat recovery bypass valve 618 and through the peripheral pressure drainage connection 14b into the drain module 500.

In other disinfection routes, the disinfecting fluid that has entered the cycler and the sterilizable connector module 600 via the disinfecting fluid connection 8a is passed through the patient bypass valve 61.
6 and through the sterilizing heat exchanger 378 via the sterilizing output connection 8b. At this time, there is no fluid flow through the other side of the germicidal heat exchanger 378 and therefore no heat loss from the disinfecting fluid while passing through the germicidal heat exchanger 378. Sterilizing fluid return connection 8
The disinfecting fluid that has entered the cycler and the sterilizable connector module 600 via c passes through the drain module 500 via the peripheral pressure discharge connection 14b.

In the final disinfecting path of the cycler and sterilizable connector module 600, the hot disinfecting fluid from the sterilizing fluid connection 8a is filled with the patient fill valve 602, sterilizable connector 604, patient drain shutoff valve 606 and the first patient. Drain valve 608
Through the negative pressure drain connecting portion 14a. At this time, drain pump 508
Is activated.

It will be clear from the above description that the entire fluid system from the water softener 206 to the patient pinch valve 624, including the drain module 500, can be disinfected chemically or by thermal disinfection.

Washing and Washing After disinfection, the disposable concentrate container 402 is connected to the manifold 404 and downstream washing operations are performed.

For the cleaning operation, the RO water preheated at the mixing temperature by the disinfecting heater 330 is discharged into the concentrate mixing module 400 via the mixing water stop valve 442 by the variable salt input pump 452, and the cleaning agent is discharged. Guided through input valve 480 into detergent compartment 410 of disposable concentrate container 402. A sufficient amount of water is applied to the detergent compartment 410.
Dissolves all the powdered detergent discharged into and stored therein. When the detergent is dissolved, the variable salt input pump valve 452 is switched to drain the solution of the detergent from the detergent compartment 410 via the detergent input valve 480. The detergent is dispensed by the variable salt input pump 452 into the concentrate reservoir 468 via the reservoir fill valve 466. Detergent from concentrate reservoir 468 passes to drain module 500 via reservoir vent valve 496 and mixing module drain connection 15.

In order to clean the heat control and sterilization module 300 and downstream components in the cycler and sterilizable connector module 600, the cleaning agent is supplied by a salt input variable pump 452 and a flow control pump bypass valve 458 and a reservoir fill. It is discharged via valve 466 to the mixing module output connection 4b. The flow of the cleaning agent is guided through the heat control and sterilization module 300 and the cycler and sterilizable connector module 600 along one of the disinfection paths described above.

After cleaning, the heat control and sterilization module 300 and the cycler and sterilizable connector module 600 are used to remove residual cleaning agents from the water preparation module 20.
Washed with purified water from zero.

The detergent uses sodium carbonate, but other detergents such as citric acid or a precursor for the detergent can also be used.

Processing Once the fluid system has been disinfected, rinsed and washed, the first step in the process is to dilute the salt and glucose in the disposable concentrate container 402. Therefore, the RO water at the mixing temperature passes through the mixed water stop valve 442 by the variable salt input pump 452 and passes through the respective input valves 482-488 to the respective salt cells 412-4.
18 are sequentially discharged. A sufficient amount of water is pumped by the variable salt input pump 452 to fill each compartment 412-418 of the disposable concentrate container 402,
The volume of fluid discharged by the salt input variable pump 452 is
Careful monitoring is performed to ensure that too much water that could overflow via 428 enters the compartments 412-418. Each compartment 41
When 2-418 is filled, each input valve 482-488 is closed while the salt is dissolved. Carefully select the volume of water input into compartments 408, 412-418. Thus, the control system detects how much water is in each compartment. If too much water is introduced into the sodium bicarbonate compartment 412 or the sodium chloride compartment 414, it is not harmful as the resulting solution is still substantially saturated.

To fill the glucose compartment 420, RO water with a mixing temperature of, for example, 37 ° C. is fed from the mixed water supply connection 4a by the flow control pump 446 to the mixing system bypass valve 440, the storage filling valve 466 and the glucose selector. Discharge into glucose compartment 420 via fluid input channel 434 by valve 444 and also by open glucose input valve 490. Glucose recirculation pump 448 is stopped at this stage. If a sufficient amount of water is discharged into the glucose compartment 420 to fill this compartment to a level that does not exceed the top of the glucose vent channel 432, the glucose input valve 490 is closed and the glucose recirculation pump 448 Recycle the glucose solution to aid dissolution. The volume of water discharged into the glucose compartment 420 determines the concentration of the glucose solution.

When glucose and salts are dissolved, the patient fluid circuit is sterilized. Therefore, R
The O water is discharged from the mixed water supply connection 4a by the positive displacement pump 352 through the mixing system bypass valve 440 and the mixing module output connection 4b, and the OL water is discharged.
Discharged through the A sterilization valve 376. After the water is preheated through the germicidal heat exchanger 378, it passes through the second OLA heat exchanger 362 to be further preheated. The positive displacement pump 352 pressurizes the water at a sufficiently high pressure so that the OLA tank 364 does not boil the temperature of the water and can raise the temperature to a suitable sterilization temperature, ie, 100 ° C. or higher, preferably 121 ° C. or higher. The heated pressurized water is supplied to the second OLA heat exchanger 3
62 and the hot side of 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 pressurized water. Similarly, when heated pressurized water passes through the patient output heat exchanger 314, heat is not transferred because the water tank in the patient output heat exchanger 314 is drained. The heated pressurized water passes through the patient output pressure relief valve 374 driven to prevent pressure drop and enters the cycler and the sterilizable connector module 600 via the sterilizing fluid connection 8a.

In the cycler and sterilizable connector module 600, heated pressurized water is first applied to the patient fill valve 602, sterilizable connector 604, and the patient drain shutoff valve 6.
06 and the sterilization output connection 8b via the sterilization bypass valve 614. The first patient drain valve 608 is closed to protect the patient drain pressure sensor 610 from elevated pressure and the output volume flow meter 650 from elevated temperature during such operations. Accordingly, the fluid path between the first patient drain valve 608 and the drain module 500 is sterilized. However, such lines are not hazardous to the patient because they do not process fluids that are disinfected and subsequently transmitted to the patient. The heated pressurized water from the germicidal output connection 8b passes through the germicidal heat exchanger 378, where the temperature of the water is reduced due to heat transfer to the relatively cooler water through the OLA germicidal valve 376. Next, the cooled and pressurized water passes through a sterilizing pressure release valve 620 that reduces the pressure to atmospheric pressure via the sterilizing fluid return connection 8c. The water cooled at ambient pressure passes through the disinfection return shutoff valve 622 and through the peripheral pressure discharge connection 14b and the heat recovery drain connection 13b to the disinfection heat exchanger 326, where the water returns to the heat recovery drain. The temperature of the water is further reduced before passing through the connection 13 c and the external waste connection 16 via the heat recovery return valve 532.

[0392] Among other sterilization stages of the cycler and sterilizable connector module 600, the patient fill valve 602 and the sterilization bypass valve 614 are closed and hot pressurized water (
The patient bypass valve 616 can be sterilized by passing through the (opened) patient bypass valve 616 to the sterilization output connection 8b.

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 sterilized. Sterilization is maintained throughout the processing session.

If the fluid path from OLA 375 to sterilizable connector 604 is sterilized,
The germicidal fluid passes continuously along such a path until the end of the processing session to maintain germicidal properties. Fluid flows from the mixed water supply connection 4a via the mixing system bypass valve 440 to the mixing module output connection 4b, and after passing through the OLA 375 where the fluid is sterilized, via the patient bypass valve 616 and the sterile heat recovery bypass valve 618. Alternatively, water from the water preparation module 200 passing through the drain module 500 may be used. The fluid may also be a PD fluid from the concentrate mixing module 400 that is sterilized in the OLA 375 or passes through the same fluid path to the drain module 500 as previously described. In this manner, the OLA 375 is not always overheated and can be operated continuously to ensure sterility. Since the PD fluid must be delivered to the patient, the patient bypass valve 616 is closed and the patient fill valve 602 is opened, allowing the PD fluid to pass to the sterilizable connector 604.

[0395] At the conclusion of the sterilization operation, the concentrated PD fluid is mixed in the concentrate reservoir 468 in the manner described above in connection with the concentrate mixing module 400.

When mixing the concentrated PD fluid, the aquarium of the patient output heat exchanger 314 opens the vent valve 320 in preparation for discharging the PD fluid to the patient, and the patient output heat exchanger pump 316.
Is filled by the drive of.

The device waits for the patient to arrive. Upon arrival of the patient, the membrane 634 on the disposable fluid line 10 is pierced by the sterilizable connector 604. The disposable fluid line 10 is connected to the mixing module output connection 4 using a positive displacement pump 352.
b, the PD fluid (or sterile water) discharged by the OLA input valve 356 is filled. The PD fluid is generated by diluting the concentrated PD fluid discharged from the concentrate reservoir 468 into the mixing chamber 450 by the salt input variable pump 452 in the mixing module 400 with the flow of purified water from the water preparation module 200.
The flow control pump 446 is bypassed during discharge of the PD fluid by opening the flow control pump bypass valve 458. PD fluid is the first OLA heat exchanger 360,
It passes through the second OLA heat exchanger 362 and the OLA heating tank 364 and is sterilized. The sterilized PD fluid is reduced to the patient temperature required by the patient output heat exchanger 314 and depressurized by the patient output pressure relief valve 374. Subsequently, the sterile PD fluid passes through the disposable dialysis line 10 via the patient fill valve 602 and the patient pinch valve 624.
The PD fluid passes through the disposable dialysis line 10 and returns to the sterilizable connector 604 via the second patient pinch valve 624. The returned fluid is the patient drain shutoff valve 6
06 and the first patient drain valve 608. Output volume flow meter 650 records the fluid flow to determine if disposable fluid line 10 has been successfully filled with PD fluid. Subsequently, the PD fluid passes through the drain module 500 via the negative pressure drain connection 14a. In this way it can be ensured that only a minimal amount of air is present in the disposable dialysis line connected to the patient's peritoneal cavity.

When the disposable fluid line 10 is full, the patient is connected to the disposable fluid line 10 so that fluid in the patient's peritoneal cavity can be drained. During the drain of the patient, the drain pump 508 is driven to discharge dialysate from the sterilizable connector 604 through the patient drain shut-off valve 606 and through the output volume flow meter 650 to the negative pressure drain connection 14a. Output volume flow meter 650 records the volume of dialysate expelled from the patient's peritoneal cavity. At the drain, a sample of the patient's dialysate is taken by the sampling module 700.

For subsequent filling and draining of the patient's peritoneal cavity, additional concentrated PD fluid is added by the mixing module 400 to the concentrate reservoir 468 while the patient is drained by the cycler and sterilizable connector module 600 and drain module 500. Mixed within.

If the patient's abdominal cavity is empty or if a predetermined drain time has elapsed, based on the drop in pressure or flow detected by the patient drain pressure sensor 610 or output volume flow meter 650, The drain pump 508 is stopped. Subsequently, the patient's abdominal cavity is filled with sterile PD fluid from the sterile fluid connection 8a of the thermal control and sterilization module 300 via the patient fill valve 602, sterilizable connector 604 and patient pinch valve 624. During filling of the patient, the pressure of the PD fluid entering the patient is monitored using the pressure tab described in detail above in connection with the cycler and the sterilizable connector module 600. The volume of PD fluid entering the patient's abdominal cavity is recorded by the input volume flow meter 350.

Once a sufficient amount of fluid has passed through the patient, the fluid system downstream of the mixing module output connection 4b must first be (sterilized) to remove any residual glucose deposits in the OLA 375. The remaining PD fluid is then washed through the drain module 500 with sterile water. Then the system waits for the patient's drain. Thus, the drain and fill cycle repeats over time to complete the processing session.

At the end of the processing session, if the patient is separated from the device 100, the residual salt or glucose solution in the disposable concentrate container 402 will be pumped through the mixing module drain connection 15 to the drain module. Next, the fluid system is rinsed with clean water using the disinfection pathway described above. The disposable concentrate container 402 and the disposable fluid line 10 are replaced. Finally, the system is operated by the inflow valve 202
Before being stopped by closing the heat drain connection valve 520 and the heat recovery / return valve 532, they are washed as described above and then washed with clean water. The device then waits for the next processing session.

When not in use for an extended period of time, the entire fluid system can be closed to the atmosphere, such as by filling it with a suitable preservative, by a technician to prevent bacterial formation.

The device can include a memory device that can store information for subsequent retrieval. The memory device may be a hard disk or a semiconductor memory device. The parameters stored in the technical recording device can be selected from the following non-limiting list: The inventory is based on time and results from processes such as cleaning, sterilization and sterilization verification, flow rates, valve and pump conditions, pump speed, and values from sensors such as conductivity, temperature and pressure. is there.

It will be apparent to those skilled in the art that various modifications and variations can be made in the device and method of the present invention without departing from the scope and spirit of the invention. For example, certain embodiments of the devices and methods of the present invention specifically described in connection with peritoneal dialysis include conventional hemodialysis or hemofiltration or hemodiafiltration or especially fluid infusion into and / or removal of fluid from a patient. It includes other medical fluid production or processing processes (including nutrient fluid production) and can be used for acute dialysis, home dialysis and continuous dialysis. Therefore, it should be understood that the present invention is not limited to the embodiments described in the specification with reference to the drawings. Further, the present invention includes modifications and variations made within the scope of the following claims and their equivalents.

[Brief description of the drawings]

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

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

2 is a schematic diagram illustrating the fluid paths of the apparatus of FIG. 1 with functional modules connected to each other.

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

FIG. 4 is a detailed schematic diagram of the heat control and sterilization module shown in FIG. 2;

FIG. 4a is a detailed schematic view showing another configuration of the heat control and sterilization module shown in FIG. 4;

FIG. 5 is a detailed schematic diagram of the concentrate mixing module shown in FIG. 2;

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

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

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

FIG. 7 is a detailed schematic view of the cycler and sterilization connector module shown in FIG. 2;

FIG. 8 is a perspective view showing a second example of a heat exchanger used for sterilizing a PD fluid according to the present invention.

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

FIG. 10 is a perspective view of a disposable concentrate container according to the present invention.

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

FIG. 12a is a perspective view showing a portion of the disposable concentrate container shown in FIG.

FIG. 12b is a perspective view showing a portion of the disposable concentrate container shown in FIG.

FIG. 12c is a perspective view showing a portion of the disposable concentrate container shown in FIG.

FIG. 13 is a perspective view showing a compartment of the disposable concentrate container shown in FIG. 10;

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

FIG. 15 is a cross-sectional view of a disposable concentrate container during installation in an apparatus of the present invention.

FIG. 16 is another cross-sectional view showing the disposable concentrate container during installation on the device of the present invention.

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

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

FIG. 19a is a schematic view of a sterilizable connector of the device of the present invention.

FIG. 19b is a schematic view of a sterilizable connector of the device of the present invention.

FIG. 19c is a schematic view of a sterilizable connector of the device of the present invention.

FIG. 19d is a schematic view of a sterilizable connector of the device of the present invention.

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

FIG. 21 is a schematic diagram of a single use sampling fluid line for use with the device of the present invention.

FIG. 22 is a detailed partial sectional view showing a compartment of the disposable concentrate container shown in FIG. 10;

FIG. 23 is a cross-sectional view of the glucose compartment of the disposable concentrate container shown in FIG.

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

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

──────────────────────────────────────────────────続 き Continuation of front page (81) Designated country EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE ), OA (BF, BJ, CF, CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG), AP (GH, GM, KE, LS, MW, SD, SL, SZ, TZ, UG, ZW), EA (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), AE, AG, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY, CA, CH, CN, CR, CU, CZ, DE, DK, DM, DZ, EE, ES, FI, GB, GD, GE, GH, GM, HR , HU, ID, IL, IN, IS, JP, KE, KG, KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, MA, MD, MG, MK, MN, MW, MX, NO, NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK, SL, TJ, TM, TR, TT, TZ, UA, UG, US, UZ, VN, YU, ZA , ZW (72) Inventors Junsson, Sven Sweden Staffanstorp, Popplewegen 8 (72) Inventors Nilsson, Eddy Susdale, Sweden Gusgatan 7 (72) Inventor Osblink, Perey Malm, Sweden, Lindeborgs Gatan 10 (72) Inventor Chevalle, Jack France Celle Cour, Thierry, France Villeurbanne, Place Wilson, 2 (72) Inventor Fourget, Alain, France Tinue, Avignon du Grand Paradis, 89 (72) 72) Inventor Lada, Ilam Lyon, France, Loude de Vienne, 4 (72) Inventor Lomaly, Jean-Louis, France Désine Charpyu, Rue Antoine Lumiere, 33-1 Cambridge, UK, Burwell, Newmarket Road 22 (72) Inventor Bell, Charles, Peter Cambridge, United Kingdom Milton Road 215 (72) Inventor Clark, Roger, William Cambridgeshire, Histon, United Kingdom Parlor Close 36 (72) Inventor Cry, Michael, John Cambridge, UK Manhattan Drive 20 (72) Inventors Edson, Raymond, Anthony UK Herfordshire, Near Royton, Littington, Malting Lane, Ramscroft (72) Inventors Evans, Peter, Alan United Kingdom Country Cambridge, Gwyedle Street 133 (72) Inventor Flack, Andrew, James United Kingdom Cambridgeshire, Hardwick, Limes Road 128 (72) Inventor Flyer, Christopher, James, Newton England Cambridge, Cottenham, High Street 149 (72) Inventor Gernsworthy, Jonathan, Randall Cambridge, UK Tennison Road 100 (72) Inventor Galer, Ian, Michael, Day United Kingdom Cambridgeshire, Eli, Little Setford, Cranwell's Way 9 (72) Inventor Hammond, Richard, Jay United Kingdom Cambridge, Great Shelfford, Granta Terrace 16 (72) Inventor McGarva, John, Robert United Kingdom Country Cambridge, Histone Road 331 (72) Inventor Nelson, Mike, Earl United Kingdom Cambridgeshire, Bur Hill, Trinity Pastures, Field View 6 (72) Inventor Shergold, Oliver, Alexander Cambridge, United Kingdom High Street 51, Cottenham, 51 (72) Inventors Snell, Richard, Andrew Cambridgeshire, England, Peterborough, Broadway 174 (72) Inventors Turner, Jake, Philip I Squirrels Cambridgeshire, Eli, Buckthorn 6 (72) Inventors Wilkinson, Eric England, Cambridgeshire, Hilton, Checkers Croft 14F Term (Reference) 4C077 AA05 AA06 BB01 BB02 CC08 DD14 DD17 EE03 GG06 GG09 JJ02 JJ18 KK09 KK19 KK19 KK23 PP29

Claims (143)

[Claims] 1. A container for use in an apparatus for producing a peritoneal dialysis fluid, the container comprising a plurality of chambers each containing a respective peritoneal dialysis fluid concentrate. 2. The container according to claim 1, wherein at least one of said chambers contains at least one powdery concentrate. 3. The container of claim 1, wherein at least one of said chambers contains a predetermined amount of concentrate that is not completely dissolved when filled with liquid in a single step. 4. The method of claim 1, wherein at least one of said chambers contains glucose in powder form, and at least one of said chambers contains inorganic salts in a substantially dry form. 2. The container according to 1. 5. A container containing, in a concentrated form, all concentrates which, when mixed with water, provide sufficient peritoneal dialysis fluid for the entire duration of the peritoneal dialysis treatment. 6. A container for use in an apparatus for producing a dialysis fluid, the container comprising at least one chamber containing a detergent and at least one other chamber containing a powdered inorganic salt. 7. A container containing a concentrated component of a dialysis fluid, wherein the container contains at least two components.
Different chambers are formed therein, each of these chambers containing a different inorganic salt, the volume of each chamber and the amount of inorganic salt contained in each chamber depends on the solution of each salt in each chamber. A container, wherein when prepared by filling with a fluid, the conductivity of the prepared solution is made to be different to exert its properties. 8. A system comprising: a plurality of other chambers containing concentrated components of a dialysis fluid; and at least one connector associated with each chamber, each said connector having at least two separate fluid channels. Containers that allow simultaneous inflow and outflow to and from each chamber. 9. The container of claim 8, wherein said at least two fluid channels are concentrically disposed on each of said connectors. 10. The at least one of the chambers includes two connectors, one of the connectors includes the at least two separate fluid channels, and another connector includes: 9. The container according to claim 8, comprising another fluid channel. 11. The container of claim 8, wherein the connector is provided in a lower region of the chamber, and wherein one of the fluid channels of the at least one connector includes a portion extending to an upper region of the chamber. 12. The container according to claim 8, wherein one of the fluid channels of each chamber comprises a diffuser for diffusing the flow of fluid into the chamber. 13. 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 aligned connectors are offset from a central axis of the container. 15. A container used to dispense powdered glucose at a treatment site for a patient, wherein the powdered glucose in the container and the supply water in the lower region of the container contain powdered glucose. 9. The container of claim 8, comprising an inlet port for dissolving glucose in the form of a body, the inlet port comprising a diffuser arranged to diffuse the water flow into the glucose in the form of powder. 16. A container for a concentrated component of a dialysis fluid, comprising: a plurality of separate chambers formed therein; and at least one connector associated with each chamber, said connectors being along a linear axis. Containers aligned with each other. 17. A universal container for patients with different dialysis treatment conditions, which can be mixed with a liquid to form a dialysis solution and a plurality of different prescriptions for different prescriptions of the patient. A container comprising: a plurality of compartments containing a quantity of a plurality of chemical components sufficient to form a component formulation of a dialysis solution; and at least one port in fluid communication of the compartments with a dialysis treatment system. 18. The container, wherein the container comprises a first compartment, a second compartment, a third compartment, a fourth compartment, a fifth compartment, and a first compartment in fluid communication with the first compartment. A port, a second port in fluid communication with the second compartment, a third port in fluid communication with the third compartment, a fourth port in fluid communication with the fourth compartment, and the fifth compartment. A fifth port in fluid communication with the first compartment in the first compartment, which can be mixed with a liquid to form a first component of the dialysis solution; and a second component of the dialysis solution. A second chemical component in the second compartment, which can be mixed with a liquid, and a first chemical component in the third compartment, which can be mixed with a liquid to form a third component of a dialysis solution; A first chemical component in the fourth compartment, which can be mixed with a liquid to form a fourth component of the solution; A first chemical component in the fifth compartment, which can be mixed with a liquid to form a fifth component, wherein the first, second, third, fourth, and fifth chemical components are of a patient. 18. The container of claim 17, provided in an amount sufficient to satisfy a plurality of different prescriptions. 19. The amount of the chemical component such that a substantial amount of the at least one chemical component does not become part of the dialysis solution and is not infused into the patient.
8. The container according to 7. 20. A container for use in a dialysis system, comprising: a first compartment containing calcium chloride; a second compartment containing magnesium chloride; a third compartment containing sodium chloride; and a detergent. A fourth compartment containing sodium bicarbonate, a sixth compartment containing glucose, and a dialysis treatment unit connected to the dialysis treatment unit at the patient's treatment location to provide dialysis at the patient's treatment location. A container comprising a plurality of ports coupled to said compartment to allow a liquid to be produced. 21. The contents of at least some of the compartments are in a substantially dry form, and at least some of the plurality of ports receive liquid passing therethrough and are substantially dry. 21. The container of claim 20, configured to mix with the contents of the form to form a solution in each compartment. 22. The container of claim 20, further comprising a seventh compartment containing lactic acid. 23. The container of claim 20, wherein the container comprises a readable display configured to be recognized by the dialysis treatment unit. 24. The compartment for accommodating a sufficient amount of respective contents to allow the container to fill one of a plurality of patient prescriptions.
The container according to 0. 25. A container for use with a dialysis system, comprising: a plurality of compartments, at least one of which contains an ionic component of a dialysis solution;
A plurality of compartments for containing at least one of a cleaning agent and a precursor of the cleaning agent to be used in cleaning the flow path of the dialysis system; and the compartment provided on the container. A plurality of ports in fluid communication with the dialysis system. 26. The compartment comprising a first compartment containing calcium chloride, a second compartment containing magnesium chloride, a third compartment containing sodium chloride, and a fourth compartment containing a cleaning agent. 26. The container of claim 25, comprising at least a compartment, a fifth compartment containing sodium bicarbonate, and a sixth compartment containing glucose. 27. The cell of claim 2, wherein the cell further comprises a seventh cell containing lactic acid.
7. The container according to 6. 28. A container for use in a dialysis system, comprising: a plurality of compartments, each containing a chemical composition to be used in a dialysis treatment; and each of said compartments in fluid communication with one of said compartments. A plurality of ports in fluid communication with the dialysis system, at least one of the ports being disposed along a surface of the container, wherein at least one of the ports is relative to a longitudinal axis of the surface of the container. A container that is asymmetric. 29. The container wherein the axes of the ports are aligned. 30. The container of claim 28, further comprising a septum on each of said ports, said septum configured to be pierced by a respective connector on a dialysis system. 31. The container of claim 28, wherein at least some of the ports include a flange that can engage a fitting on a dialysis system. 32. The container of claim 28, wherein the free ends of said ports are coplanar. 33. A plurality of compartments, a first compartment containing calcium chloride, a second compartment containing magnesium chloride, a third compartment containing sodium chloride,
29. The container of claim 28, comprising a fourth compartment containing a detergent, a fifth compartment containing sodium bicarbonate, and a sixth compartment containing glucose. 34. The compartment further comprising a seventh compartment containing lactic acid.
4. The container according to 3. 35. The container of claim 28, wherein the outer surface of the container includes a barcode symbol configured to be read by a barcode reader on the dialysis system. 36. The container of claim 28, wherein at least some of the compartments each have a ventilation tube. 37. At least some of the ports include a first fluid path for passing air into a respective one of the compartments, and a fluid for passing a liquid through the respective one of the compartments. A second fluid path for removing the solution from each one. 38. A container for use with a dialysis system, comprising: a plurality of compartments each containing a chemical composition for use in a dialysis treatment; a plurality of ports in fluid communication with the compartments with the dialysis system; A readable indication on said container configured to be recognized and indicating the contents of the compartment. 39. The container wherein the readable indication is a bar code symbol. 40. The container according to claim 38, wherein the readable display includes information regarding the contents of the compartment. 41. The container of claim 38, wherein the readable display includes patient prescribing information. 42. The compartment comprising a first compartment containing calcium chloride, a second compartment containing magnesium chloride, a third compartment containing sodium chloride, and a fourth compartment containing a cleaning agent. 39. The container of claim 38, comprising at least a compartment, a fifth compartment containing sodium bicarbonate, and a sixth compartment containing glucose. 43. The compartment further comprising a seventh compartment containing lactic acid.
3. The container according to 2. 44. A container for use with a dialysis system, comprising: a first compartment including a first vent channel and a first fluid channel; a second compartment including a second vent channel and a second fluid channel; A third compartment including a third vent channel and a third fluid channel; a fourth vent channel, a fluid inlet channel, a diffuser in fluid communication with the fluid inlet channel, a fluid outlet channel, and glucose in fluid communication with the fluid outlet channel. A fourth compartment including a filter, a fifth compartment including a fifth vent channel and a liquid channel, a sixth compartment including a first air vent / fluid flow channel and a first fluid inlet / outlet channel, A seventh compartment including a second air vent / fluid flow channel and a second fluid inlet / outlet channel; and the first vent channel. A first port in fluid communication with the first and second fluid channels; a second port in fluid communication with the second ventilation channel and the first fluid channel; and a fluid communication with the third ventilation channel and the third fluid channel. A third port, a pair of fourth ports, one of which is in fluid communication with the fluid inflow channel and the fluid outflow channel, and the other of which is in fluid communication with the fourth ventilation channel; A fifth port in fluid communication, a sixth port in fluid communication with the first air vent / fluid flow channel and the first fluid inflow / outflow channel, a second port vented / fluid flow channel, and a second fluid. A seventh port in fluid communication with an inflow / fluid outflow channel, wherein the plurality of compartments comprise a plurality of different dialysis solution formulations. Sized to accommodate the amount of each of the components of the dialysis solution can only be satisfied, the port container may be passed through dialysis machine fluid communication. 45. Calcium chloride in said first compartment capable of being mixed with a liquid to form a first component of a dialysis solution; and said second compartment capable of being mixed with a liquid to form a second component of a dialysis solution. Lactic acid, a cleaning agent in the third compartment that can be mixed with a liquid to form a cleaning solution, and a cleaning agent in the third compartment that can be mixed with a liquid to form a third component of a dialysis solution and that is substantially dry. The glucose in the fourth compartment; the magnesium chloride in the fifth compartment, which can be mixed with a liquid to form a fourth component of the dialysis solution; and the sixth, which can be mixed with the liquid to form the fifth component of the dialysis solution. 45. The container of claim 44, further comprising: sodium bicarbonate in a compartment; and sodium chloride in the seventh compartment capable of being mixed with a liquid to form a sixth component of a dialysis solution. 46. An apparatus for preparing a peritoneal dialysis fluid for infusion into a patient's peritoneal cavity at a treatment location, comprising: a plurality of chambers each containing a concentrate of one component of the peritoneal dialysis fluid; A fluid mixer disposed to mix with a liquid to prepare the peritoneal dialysis fluid; a sterilizer disposed to sterilize at least one of the liquid and the peritoneal dialysis fluid; A patient filling connection disposed in fluid communication with the dialysis fluid to the peritoneal cavity of the patient, wherein at least one of the concentrates is at least substantially dry when used in the device. A device that is partially dissolved to form part of a dialysis fluid. 47. The apparatus of claim 46, wherein one of the chambers has a substantially dry form of the permeant. 48. The device of claim 47, wherein said osmotic agent is glucose. 49. The apparatus of claim 46, wherein each concentrate is a single concentrate. 50. Each of the chambers 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. An apparatus according to claim 1. 51. 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, a lactic acid solution, 51. The device of claim 50, comprising glucose in a substantially dry form. 52. The apparatus of claim 46, further comprising a chamber containing a cleaning agent. 53. The apparatus of claim 46, further comprising a controller for controlling the fluid mixer to selectively prepare a peritoneal dialysis fluid selected from a plurality of different composition groups.
An apparatus according to claim 1. 54. The concentrate of claim 53, wherein the concentrate comprises a plurality of electrolytes, and the controller is operable to selectively prepare a plurality of peritoneal dialysis fluid compositions having different relative electrolyte concentrations. apparatus. 55. The apparatus according to claim 53, wherein the controller comprises data input means for storing patient prescribing information. 56. The apparatus, wherein the apparatus is arranged to pre-treat the at least one concentrate in a substantially dry form in a chamber with a liquid comprising water, the amount of the concentrate in the chamber and the amount of the concentrate in the chamber. The size is such that the concentrate is only partially dissolved when the chamber is filled with liquid, and the apparatus comprises a fluid line for removing liquid containing dissolved concentrate from the chamber. 47. The apparatus of claim 46, further comprising: and a fluid line for adding substantially the same amount of liquid to the chamber as removed. 57. The concentrate removal fluid line is used during pretreatment to inject a liquid containing water into the chamber, and the liquid addition fluid line is used during pretreatment to release air from the chamber. 57. The device of claim 56, wherein 58. The at least one concentrate in the partial lysis chamber comprises:
57. The device according to claim 56, wherein the device is selected from sodium chloride and sodium bicarbonate. 59. The apparatus is arranged to pre-treat the at least one concentrate in a substantially dry form in a chamber with a liquid comprising water, the amount of the concentrate in the chamber and the amount of the concentrate in the chamber. 47. The apparatus of claim 46, wherein the dimensions are such that the concentrate is completely dissolved when the chamber is filled with liquid. 60. The apparatus of claim 59, wherein said at least one concentrate in substantially dry form is selected from the group consisting of magnesium chloride and calcium chloride. 61. The at least one concentrate in a substantially dry form includes at least first and second concentrates in a substantially dry form, wherein the first concentrate is in a first chamber and the device Is arranged to pre-treat the first concentrate in a substantially dry form with a liquid comprising water, wherein the amount of the first concentrate in the first chamber and the size of the first chamber are: The first concentrate is only partially dissolved when the first chamber is filled with a liquid, and the apparatus includes a fluid for removing a liquid containing the dissolved concentrate from the first chamber. A line, and a fluid line for adding substantially the same amount of liquid to the first chamber as removed, wherein the second concentrate is in the second chamber, and the apparatus comprises: Said second concentration in dry form Is arranged to be pre-treated with a liquid containing water, and the amount of the second concentrate in the second chamber and the size of the second chamber are reduced by the second concentration when the second chamber is filled with the liquid. 47. The device of claim 46, wherein the object is completely dissolved. . 62. A chamber containing a permeant, wherein the apparatus injects a liquid containing water into the permeant chamber, removes a liquid containing dissolved permeant from the permeant chamber, and a liquid containing dissolved permeant. 47. The apparatus of claim 46, further comprising a flow circuit for re-injecting the fluid into the osmotic chamber. 63. The apparatus of claim 62, further comprising a heater for heating the liquid containing the dissolved permeant as it circulates through the flow circuit. 64. The apparatus of claim 62, wherein the apparatus further comprises a vent to allow gas to escape as the liquid containing the dissolved permeant circulates through the flow circuit. 65. The device of claim 62, wherein the osmotic agent comprises glucose. 66. The apparatus of claim 46, wherein the sterilizer is a heat sterilizer that sterilizes peritoneal dialysis fluid at elevated pressure. 67. The apparatus according to claim 66, wherein the heat sterilizer is disposed downstream of a fluid mixer. 68. A system for pretreating a substantially dry form of glucose at a patient's treatment site to form a dialysis solution, the system containing a chemical composition used to form the dialysis solution. One of them includes a plurality of compartments containing glucose in a substantially dry form, and a mixing module fluidly connected to the compartments, wherein the mixing module can be in fluid communication with the compartments. A flow circuit, wherein at least one of these flow paths is configured to form a glucose solution by passing a liquid through a compartment containing glucose;
The system further comprising a mixing chamber, wherein the mixing module mixes the glucose solution, the liquid, and the contents of the compartment to form a dialysis solution. 69. The system of claim 68, wherein the compartment containing glucose includes a diffuser that facilitates dissolving the dried glucose out of the liquid. 70. A method of peritoneal dialysis treatment utilizing dialysis fluid generated at a treatment site of a patient, the method comprising: a plurality of compartments each containing one of the different components of the dialysis fluid; Providing a dialysis device, at least one of which is in a substantially dry form; mixing a liquid and at least some of the components to prepare a component solution in the device at the point of treatment of the patient; Forming a dialysis fluid in the device at the patient's treatment location, wherein forming the dialysis fluid comprises mixing the component solutions; and placing the dialysis device in fluid communication with a patient's peritoneal cavity. Flowing the dialysis fluid into the peritoneal cavity; and draining the dialysis fluid from the peritoneal cavity. 71. The method of claim 70, wherein said at least one component in substantially dry form comprises a penetrant. 72. The method of claim 71, wherein said penetrant is glucose. 73. The method according to claim 70, further comprising: flowing raw water into the dialysis device; and purifying the raw water to produce purified water, wherein the liquid comprises at least purified raw water. The described method. 74. The method of claim 70, further comprising sterilizing at least one of a liquid and a dialysis fluid in the dialysis device. 75. The dialysis device includes a removable container in which a plurality of components are disposed, and a processor, the method comprising: fluidly connecting the container to the processor at the start of treatment. 70. The method of claim 70, further comprising: removing the container from the processor at the end of treatment. 76. The method of claim 70, wherein forming the dialysis fluid comprises detecting a concentration of the chemical composition in the component solution and adjusting a flow of the component solution to the mixing chamber based on the detection. the method of. 77. A method of preparing a medical aqueous solution from a plurality of concentrates, comprising providing a plurality of concentrates in separate chambers, at least one of which is in substantially dry form. Pretreating said at least one concentrate in dry form with a liquid comprising water to form at least one dissolved concentrate; combining said at least one dissolved concentrate with said concentrate. Passing through the mixing vessel through the flow controller, the flow controller associated with the at least one dissolved concentrate such that a metered volume of the concentrate passes through the flow controller. Adjusting the concentration of the concentrate to determine the amount of the concentrate to be supplied to the mixing vessel; and supplying the concentrate when the predetermined amount has been supplied. Terminating. 78. Adjusting a first flow conditioner associated with the first concentrate so that the first concentrate passes at a metered flow rate through the first flow conditioner, and supplying the first concentrate to the mixing vessel. Measuring the concentration of the first concentrate to determine the amount of the concentrate to be applied; terminating the supply of the first concentrate when the predetermined amount has been supplied; Adjusting a second flow controller associated with the second concentrate to pass the second flow controller at a metered flow rate, and determining an amount of the concentrate supplied to the mixing vessel. Measuring the concentration of the second concentrate to terminate the supply of the second concentrate when the predetermined amount has been supplied, and adjusting the concentration of each of the further concentrates. , Passing, measuring and terminating steps are repeated until a predetermined amount of each 78. The method of claim 77, wherein an aqueous solution comprising the concentrate is provided. 79. The method of claim 77, wherein the metered volume is passed by a pump, which pump is also used to pump each concentrate in turn into a mixing vessel. 80. The method of claim 77, wherein the same measuring means is used to measure the concentration of each concentrate in turn. 81. The method of claim 77, further comprising diluting at least one of the concentrates after exiting the chamber and before passing through a mixing vessel. 82. A pump for passing at least one concentrate along a concentrate flow line at a metered flow rate, and a second pump for passing water at a metered flow rate along the water flow line; Mixing the at least one concentrate provided along the concentrate flow line with water provided along the water flow line to provide a diluted concentrate. Method. 83. Measuring the concentration of at least one of the at least one concentrate and the diluted concentrate, and providing a dilution ratio required to obtain a desired concentration of the diluted concentrate. Controlling the pump.
The method described in. 84. Passing the diluted concentrate at a flow rate to the mixing vessel, measuring the concentration of the diluted concentrate, multiplying the measured concentration by the flow rate, and the result of the multiplication. Accumulating over time to obtain the total amount of concentrate supplied to the mixing vessel; and, when a predetermined amount of concentrate has been supplied to the mixing vessel, the dilution concentrate is transferred to the mixing vessel. 82. The method of claim 81, further comprising terminating the passage. 85. Measuring at least one of the properties of the concentrate and the properties of the concentrate after dilution downstream of the chamber, and based on the measurement the concentrate is predicted in the chamber. 78. The method of claim 77, further comprising determining whether the concentrate is to be concentrated. 86. The method of claim 77, further comprising passing the liquid in the mixing vessel toward a point of use and diluting the liquid downstream of the mixing vessel. 87. The step of determining the concentration of the concentrate in the diluted liquid using the same measurement means used to determine the concentration of the concentrate during feeding to the mixing vessel. 89. The method of claim 86, comprising: 88. The method according to claim 88, further comprising the step of switching the discharge direction after the supply of the concentrate is completed, and discharging the liquid from the liquid source through the associated flow controller to clean the path between the liquid source and the flow controller. 78. The method of claim 77, comprising: 89. An apparatus for producing a medical aqueous solution from a plurality of concentrates, at least one of which is in substantially dry form, wherein the apparatus is in communication with a plurality of chambers, each containing a respective concentrate. At least one flow line disposed to pre-treat the at least one concentrate in a substantially dry form with a liquid comprising water to form at least one dissolved concentrate. A mixing vessel disposed to receive the at least one dissolved concentrate; and a mixing vessel disposed in combination with the at least one dissolved concentrate to pass the concentrate through the mixing vessel. A flow controller, a measuring means arranged to measure the concentration of the at least one dissolved concentrate, and a predetermined amount of the dissolved concentrate to the mixing vessel. During the measurement of the concentration of the dissolved concentrate by the measuring means, the metered volume of the at least one dissolved concentrate is supplied to the mixing vessel via the associated flow controller for feeding the cell. A pump arranged to discharge. 90. A flow controller, further comprising a flow controller associated with each concentrate, wherein during use of the apparatus, during each concentration measurement of the concentrate to supply a predetermined amount of the concentrate to the mixing vessel. 90. The apparatus of claim 89, wherein the metered volume of the object is discharged to the mixing vessel via the associated flow regulator. 91. The apparatus of claim 89, wherein a pump is arranged to pump each concentrate in liquid form into the mixing vessel in sequence. 92. The apparatus according to claim 89, wherein said measuring means is arranged to measure the concentration of each concentrate in order. 93. The apparatus of claim 89, wherein the apparatus is arranged to dilute the concentrate after exiting the chamber and before passing the concentrate to a mixing vessel. 94. A fluid flow line along which concentrate is pumped at a flow rate metered by said pump, and a water flow line along which water is pumped at a flow rate metered by a second pump. 94. The apparatus of claim 93, wherein the concentrate flow line merges with the water flow line to mix the concentrate and water during use to dilute the concentrate before passing to the mixing vessel. 95. The measuring means is arranged to measure the concentration of at least one of the concentrate and the diluted concentrate, and in use, the pump operates the diluted concentrate of a desired concentration. 95. The device of claim 94, wherein the device is controlled to provide the required dilution ratio to obtain. 96. The apparatus, wherein the apparatus is arranged to pass the diluted concentrate at a certain flow rate to the mixing vessel by a pump during the measurement of the concentration of the diluted concentrate by the measuring means. Multiply the measured concentration by the flow rate, accumulate the result of the multiplication over time in order to obtain the total amount of the concentrate supplied to the mixing vessel, a predetermined amount of the concentrate is the mixing vessel 94. The apparatus of claim 93, further comprising a processor for terminating the passage of the diluted concentrate to the mixing vessel when fed to the mixing vessel. 97. The apparatus, wherein the apparatus is arranged to measure at least one of a property of the concentrate and a property of the concentrate after dilution downstream of the chamber, the apparatus comprising: 90. The apparatus of claim 89, further comprising an inspection device to determine if the concentrate is a concentrate to be expected in the chamber. 98. The apparatus of claim 89, further comprising a flow path configured to allow liquid in the mixing vessel to pass toward a point of use and to be diluted downstream of the mixing vessel. 99. The measuring means utilized to measure the concentration of the concentrate supplied to the mixing vessel comprises: measuring the concentration of the concentrate in a diluted liquid downstream of the mixing vessel. 99. The apparatus of claim 98, wherein a device is also utilized. 100. The pump is reversible and connectable to a liquid source, and in use of the device, after pumping the concentrate, the pump removes the liquid from the liquid source to an associated flow rate. 59. Apparatus according to any of claims 48 to 58, wherein the apparatus is reversed to pump through a regulator to clean the path between the liquid source and the valve. 101. A method of making a dialysis solution for use during a dialysis treatment period for a patient, comprising: providing a plurality of compartments containing different chemical components; Adding to form a component of the dialysis solution in the compartment; and dispensing a sufficient amount of the dialysis solution to complete the dialysis treatment time without using at least a portion of the component. And discarding unused portions of the at least one component. 102. A method of forming a dialysis solution at a treatment site for a patient, comprising: adding a liquid to a plurality of compartments containing a plurality of different chemical components for use in forming the dialysis solution. Forming; flowing the chemical component solution into a mixing chamber; monitoring at least one of the chemical component solutions flowing into the mixing chamber; and monitoring at least one of the chemical component solutions based on the monitoring. Controlling the flow to the mixing chamber. 103. A method of forming a dialysis solution at a treatment site for a patient, comprising adding a liquid to a plurality of different chemical components including glucose in a dry form to form a plurality of different chemical component solutions including a glucose solution. Forming; forming a mixing module dialysis solution comprising a mixture of the chemical component solutions; flowing the dialysis solution from the mixing chamber to the patient dialysate line in fluid communication with the mixing module with a patient dialysate line. And a step that enables the method. 104. A method of producing a dialysis solution at a patient treatment site, comprising providing a plurality of components of the dialysis solution at a patient treatment site, at least some of said components being in a substantially dry form. Pretreating a substantially dry component of the dialysis solution at a patient treatment site to form a solution component of the dialysis solution; mixing at least some of the solution components together to form a concentrated solution Forming a dialysis solution by diluting the concentrated solution with a liquid. 105. A method of performing dialysis treatment, comprising: adding a liquid to a plurality of different chemical components to form a plurality of chemical component solutions for use in forming a dialysis solution; Mixing at least a portion thereof together in a mixing module to form a concentrated solution; diluting the concentrated solution with a liquid to form a dialysis solution in the mixing module; and dialyzing the patient from the mixing module. Flowing through a liquid line. 106. A system that allows for selective composition of different compositions of a dialysis solution, wherein the system contains an amount of a plurality of chemical components that can be mixed with a liquid to form a plurality of components of the dialysis solution. A container having a plurality of compartments; at least one module coupled to the compartment, fluidly connected to a source of the liquid, flowing the liquid through the compartment to form a component in the compartment. A plurality of fluid pathways; a mixing chamber in fluid communication with the fluid pathway such that the components can flow from the compartment to the mixing chamber; and regulating a flow of the components from the compartment to the mixing chamber. At least one module, including at least one flow controller, and an amount of a component that controls the at least one flow controller and flows into the mixing chamber. And a controller that regulates. 107. An apparatus for producing a peritoneal dialysis fluid at a treatment site for introduction into a peritoneal cavity of a patient, comprising: a plurality of chambers each containing a concentrate of one component of the peritoneal dialysis fluid; A fluid mixer arranged to mix the concentrate with a liquid to prepare a peritoneal dialysis fluid; and selectively controlling the fluid mixer to prepare a peritoneal dialysis fluid selected from a group of different compositions. A sterilizer disposed to sterilize at least one of the liquid and the peritoneal dialysis fluid; and a sterilizer disposed to fluidly communicate the peritoneal dialysis fluid to a peritoneal cavity of a patient. A patient filling connection provided, wherein the controller comprises data input means for receiving predetermined prescription information for the patient, wherein the controller is configured to perform peritoneum based on the predetermined reception prescription information. An apparatus operable to control the fluid mixer to prepare a dialysis fluid composition. 108. The apparatus of claim 107, wherein said concentrate comprises a plurality of electrolytes, and said controller is operable to selectively prepare peritoneal dialysis fluid compositions having different relative electrolyte concentrations. 109. The chamber is in the form of a compartment of a container, and all concentrates required to prepare the peritoneal dialysis composition are provided in the compartment.
Device according to 07. 110. An apparatus for producing a peritoneal dialysis fluid at a treatment site for introduction into a peritoneal cavity of a patient, comprising: a plurality of chambers, each containing a concentrate of one component of the peritoneal dialysis fluid; A fluid mixer arranged to mix the concentrate with a liquid to prepare the peritoneal dialysis fluid; andcontrolling the fluid mixer to selectively select a peritoneal dialysis fluid selected from a group of different compositions. A controller disposed to prepare; a sterilizer disposed to sterilize at least one of the liquid and peritoneal dialysis fluid; and a fluid communication of the peritoneal dialysis fluid to a patient's peritoneal dialysis. Wherein the concentrate comprises a plurality of electrolytes and the controller is operative to selectively prepare a peritoneal dialysis fluid composition having different relative electrolyte concentrations. A device that can move. 111. The apparatus of claim 109, wherein said plurality of chambers are formed by a single container. 112. The apparatus according to claim 111, further comprising a container engaging portion engaging the container and biasing the container to a position where the chamber is open for communication with parts of the device. Equipment. 113. Each of the chambers includes a means for defining an opening, and a flange provided near the opening, and the container engaging portion is arranged to engage with the flange near the opening. The apparatus of claim 112. 114. The openings are linearly aligned with one another and the container engaging portion is a pair of laterally spaced members disposed to engage the flanges formed on opposite sides of the opening. 114. The apparatus of claim 113, comprising: 115. The apparatus according to claim 110, wherein the chamber comprises a pierceable seal to open the chamber, and wherein the apparatus comprises a plurality of spikes each piercing the seal of the chamber to open the chamber. The described device. 116. The apparatus of claim 115, wherein the spike comprises two fluid flow channels. 117. The apparatus of claim 115, wherein the spikes comprise a pair of spikes for piercing a permeant receiving chamber to form at least three fluid flow channels. 118. The apparatus of claim 115, further comprising a cover over the corresponding spike when the container is separated so that the spike can be disinfected. 119. The apparatus of claim 118, further comprising a container engaging portion disposed to engage the cover and bias the cover to its covering position. 120. The water purifier further comprises a first reverse osmosis membrane unit and a second reverse osmosis membrane unit, wherein each of the reverse osmosis membrane units comprises:
An inlet, a purified water outlet, and a wastewater outlet, wherein the purified water outlet of the first reverse osmosis membrane unit is in fluid communication with the inlet of the second reverse osmosis membrane unit; 108. The apparatus of claim 107, wherein a wastewater outlet is in fluid communication with an inlet of the first reverse osmosis unit. 121. The water purifier further comprises at least one of a fine substance filter, a coarse substance filter, and a water softener upstream of an inlet of the first reverse osmosis membrane unit. The described device. 122. The apparatus according to claim 120, wherein the water purifier further comprises a deaerator upstream of an inlet of the first reverse osmosis membrane unit. 123. An apparatus for preparing a peritoneal dialysis fluid at a treatment site, comprising: a water inlet disposed to receive water from a water supply source; and a water purifier disposed to purify water from said water inlet. A fluid mixer disposed to mix a dialysis fluid concentrate with the purified water to prepare a peritoneal dialysis fluid; a sterilizer disposed to sterilize the peritoneal dialysis fluid; A patient filling connection disposed in fluid communication with the supplied peritoneal dialysis fluid to a patient's peritoneal cavity, wherein the sterilizer heat sterilizes the peritoneal dialysis fluid at a sterilization temperature and elevated pressure. Equipment that is a heat sterilizer. 124. The apparatus of claim 123, wherein said pasteurizer is disposed downstream of a fluid mixer. 125. The sterilizer of claim 123, wherein the sterilizer includes a sterile flow path, and is arranged to heat sterilize the peritoneal dialysis fluid as the peritoneal dialysis fluid flows along the sterile flow path. apparatus. 126. A flow path downstream of the thermodisinfector for flowing the sterilized peritoneal dialysis fluid to the patient filling connection, and wherein the sterile peritoneal dialysis fluid flows along the flow path. 126. The apparatus of claim 125, further comprising a dialysis fluid cooler arranged to cool the sterilized peritoneal dialysis fluid. 127. The device is arranged to heat sterilize the flow path prior to use so that the sterilized peritoneal dialysis fluid flows to the patient filling connection.
The device according to claim 26. 128. The apparatus of claim 123, wherein said sterilizer is arranged to heat said peritoneal dialysis fluid to a temperature of at least about 140 ° C. 129. The apparatus of claim 123, wherein the sterilizer is arranged to heat the peritoneal dialysis fluid to obtain a value of _Fo given by the following formula for at least about 20 minutes. Where L is the length of the sterile fluid passage for the peritoneal dialysis fluid, S is the internal cross-sectional area of the sterile fluid passage, and Q is the volume flow rate of the peritoneal dialysis fluid along the sterile fluid passage. T (y) indicates the temperature distribution of the peritoneal dialysis fluid as a function of distance from the beginning of the sterile fluid passage. 130. A dialysis treatment method comprising: connecting a patient dialysate tube to a connector on a dialysis treatment system; flowing a dialysis solution to the patient dialysate tube along a flow path of the dialysis treatment system. Sterilizing a dialysis solution flowing to the patient dialysate tube with a sterilization module in the system; and sterilizing at least most of a flow path in the dialysis treatment system, wherein sterilizing the flow path includes: Flowing a sterilizing liquid through the flow path between the sterilizing module and a connector. 131. A dialysis system that can use raw water to produce a dialysis solution at a patient's treatment location, comprising: a water treatment module that processes the raw water to purify the raw water; Mixing the clarified raw water with a plurality of chemical components to form a dialysis solution;
A mixing module in fluid communication with the water treatment module; and a fluid module in fluid communication with the mixing module and connected to a patient dialysate line to allow the dialysate to flow from the system to the patient dialysate line. System, including connectors. 132. A system for forming a dialysis solution based on patient information comprising: a processor for processing prescription information specific to a dialysis treatment patient; a mixing module for mixing components of the dialysis solution to form a dialysis solution. A controller that controls the mixing module based on the prescribing information such that the mixing module forms a dialysis solution in a component amount sufficient for a patient. 133. The system of claim 132, wherein the system further comprises a memory device for storing the prescription information. 134. The memory device is a portable device, and the system further comprises a reader for reading the prescription information from the memory device.
3. The system according to 3. 135. A method of peritoneal dialysis treatment using a dialysis solution prepared according to a predetermined composition at a treatment site of a patient, comprising: forming a dialysis solution from components of the dialysis solution at the treatment site of the patient. Providing an apparatus comprising: a container containing a component of the dialysis solution, the container containing an amount of the component sufficient to form one of a plurality of different compositions of the dialysis solution. Combining with the processing device; processing information regarding a predetermined patient prescription with the processing device; forming a predetermined composition of the dialysis solution in the processing device according to the patient's prescription; Fluidly communicating the device with a patient's peritoneal cavity; interlocking the dialysis solution into the peritoneal cavity; removing the dialysis solution from the peritoneal cavity; and separating the container from the processing device. The method comprising the door. 136. The method further comprising the step of inputting prescription information, wherein the inputting step includes reading the information from the smart card at least once, receiving the information through a modem, and manually inputting the information on a user interface. 135. The method of claim 135, comprising: 137. The step of inputting information includes inputting a desired permeant concentration, and forming the predetermined composition includes preparing a dialysis solution at approximately the desired permeant concentration. 136. The method of claim 136. 138. The step of forming a predetermined composition of the dialysis solution includes: adding a liquid to the different chemical components; processing information relating to a predetermined patient prescription in a processing device; Forming a predetermined composition of the dialysis solution in the processing device in response thereto; fluidly communicating the device with a patient's peritoneal cavity; flowing the dialysate solution into the peritoneal cavity; and 136. The method of claim 135, comprising removing the dialysis solution; and separating the container from the processing device. 139. The step of forming a predetermined composition of the dialysis solution includes the steps of adding a liquid to different chemical components to form different chemical component solutions, and mixing the amounts of the chemical component solutions. 135. The method of claim 135, comprising: 140. The method of claim 139, wherein at least some of said chemical components are in a substantially dry form. 141. A water purification module, comprising: a raw water inlet; at least one particle filter in fluid communication with the raw water inlet; and a degassing chamber configured to remove gas from the water. A deaeration section, a first reverse osmosis membrane unit having a first inlet, a first purified water outlet and a first wastewater outlet, and a second reverse osmosis membrane having a second inlet, a second purified water outlet and a second wastewater outlet. A water purification module, wherein the first purified water outlet is in fluid communication with the second inlet, and the second wastewater outlet is in fluid communication with the first inlet. A heat control and sterilization module comprising a plurality of heat exchangers configured to transfer heat between liquids flowing in the system; and a fluid communication with the water purification module and the heat control and sterilization module. A concentrate mixing module, comprising: a plurality of fluid couplers comprising fluid channels, at least some of which are configured to be in fluid communication with compartments each containing a concentrated component of the dialysis solution; and A plurality of valves comprising a valve associated with each fluid coupler to regulate at least one of the flow of fluid to and from the compartment; A concentrate reservoir in fluid communication with the fluid coupler; at least one conductivity sensor configured to detect a conductivity of a liquid flowing to the concentrate reservoir; the concentrate reservoir and the water purification module. A mixing chamber in fluid communication with the purified water outlet of the mixing chamber to enable formation of a dialysis solution; and at least one in fluid communication with the fluid coupler, concentrate reservoir, and mixing chamber. A concentrate mixing module comprising: And a system comprising: 142. The system of claim 141, wherein the fluid coupler comprises a spike adapted to extend into a port on the container. 143. The system of claim 141, wherein said thermal control and sterilization module is configured to heat dialysis fluid flowing from said mixing chamber to said connector to sterilize said dialysis fluid.