EP3645105A1

EP3645105A1 - Peritoneal dialysis system

Info

Publication number: EP3645105A1
Application number: EP18746100.9A
Authority: EP
Inventors: Peter Wabel
Original assignee: Fresenius Medical Care Deutschland GmbH
Current assignee: Fresenius Medical Care Deutschland GmbH
Priority date: 2017-06-28
Filing date: 2018-06-28
Publication date: 2020-05-06
Also published as: AU2018293333A1; AU2018293333B2; KR102661124B1; DE102017114401A1; CN110799240A; KR20200023429A; JP2020525236A; JP7245181B2; US20200121843A1; WO2019002477A1

Abstract

The invention relates to a peritoneal dialysis system comprising at least one peritoneal dialysis device. The peritoneal dialysis system further has at least one water unit for preparing and/or metering water and at least one concentrate container, said concentrate container having at least one connector or being connected to same, and the water unit and/or the peritoneal dialysis device has at least one receiving area for the connector. The connector has at least one piece of information, preferably in the form of at least one barcode, which represents the quantity of the water to be filled into the concentrate container or allowing an inference to be made thereof, and the water unit or the peritoneal dialysis device is designed to read said information and carry out or trigger the addition of water in accordance with the read information.

Description

Peritoneal! ialysesystem

The present invention relates to a peritoneal dialysis system comprising at least one peritoneal dialysis machine.

Peritoneal dialysis is performed by patients at a typical treatment site.

It can be a practice or clinic. Often the peritoneal dialysis takes place at home or in the home bedroom. In the context of peritoneal dialysis treatment solution bags are used with fresh dialysis solution, which is introduced via a tube system and a patient catheter into the abdominal cavity of the patient and there for a certain period of time remains. The peritoneum acts as a dialysis membrane which allows an exchange between the dialysis solution and the patient's blood in the form that contaminants from the patient's blood are transferred via the membrane into the dialysis solution. After a certain period of residence, the dialysis solution is removed again from the abdominal cavity. In particular, in cases where the patient performs the treatment at home, there is a greater logistical effort that solution bags must be transported home and stored there in sufficient numbers. Another disadvantage is that the production of the solution bag is associated with a certain cost, which makes their provision more expensive for the patient.

It is therefore the object of the present invention to provide a peritoneal dialysis system with which the peritoneal dialysis treatment can also be carried out at home with a comparatively low logistical effort and at low cost.

This object is achieved by a peritoneal dialysis system having the features of claim 1.

Thereafter, it is provided that the peritoneal dialysis system further comprises at least one water unit for treatment and / or dosage of water and at least one concentrate container, wherein the concentrate container has at least one connector or is in communication therewith and wherein the water unit and / or the Peritonealdialysegerät at least a connector for the connector, wherein the connector has at least one piece of information, preferably in the form of at least one bar code, which represents the amount of water to be filled into the concentrate container or conclusions on it, and wherein the water unit or the Peritonealdialysegerät is formed, this information read out and cause the addition of water according to the information read or cause.

According to the invention, it is thus provided that water is introduced into the concentrate container or containers by means of the water unit and that in this way the solution containers suitable for the treatment are obtained and the ready-to-use dialysis solution or a part thereof is produced. This means that such solution containers do not have to be transported to the patient, but rather It suffices to provide the concentrate containers at the point of care (PoC), which may, for example, be a room at home in the patient. Only there is the finished dialysis solution produced. This facilitates transport and storage, since the concentrate containers require much less space and are easier and less expensive than the finished solution bags or other solution container.

The term "container" in the context of the present invention includes all conceivable containers, such as for example those with solid walls, such as boxes or even those with flexible walls, such as bags.

The information as to how much water has to be poured into the concentrate containers is located on the connector (s), which may be located directly on the concentrate container, but preferably on the end of a hose connected to the interior of the concentrate container. In this case, the information can concretely contain the amount (mass, volume, etc.) of the water to be filled in, or else permit conclusions to be drawn indirectly. This may be done, for example, such that the information contains only the type of concentrate and is made therefrom e.g. from a storage medium, the amount of water to be added to the concentrate to obtain the finished dialysis solution or a part thereof is read out.

Alternatively, other liquids, e.g. Electrolyte solutions, used for the production of the finished dialysis solution.

The term "finished dialysis solution" is understood to mean that the finished dialysis solution is mixed, for example in the peritoneal dialysis machine, from two or more parts, ie In this case, the finished dialysis solution is produced only in the peritoneal dialysis machine from the parts of the finished dialysis solution. The water unit is preferably designed to be connected to a conventional domestic water system or to a conventional faucet.

Alternatively, it is also conceivable to provide another liquid supplying device instead of one water faucet, e.g. in the form of a water or liquid tank.

The water unit may e.g. have at least one RO unit and / or one or more filters. In the RO unit purified water is produced by reverse osmosis from tap water. Further purification is possible by further treatment of water in one or more filters. These can be upstream and / or downstream of the RO unit.

Instead of an RO unit, another unit for producing pure water may also be present, such as e.g. a unit for deionization, for distillation or else a combination of one or more of the abovementioned units.

It is conceivable that the concentrate container is a concentrate bag and / or that at least one tube is located on the concentrate container, at the end of which the connector is arranged. The one or more hoses are in fluid communication with the interior of the concentrate container (s) so that water may be introduced through the hose into the concentrate container and the finished dialysis solution or a portion thereof removed from the concentrate container to the peritoneal dialysis machine via the same or a different hose can.

Preferably, it is contemplated that the concentrate container has at least two connectors or is in communication therewith, at least one of the connectors containing said information and the other connector containing the same or different information, and wherein both the peritoneal dialysis apparatus and Also, the water unit has at least one receptacle for each one of these connectors.

A preferred embodiment of the invention thus consists in that the concentrate container is designed with at least two hoses, each of which is provided with a connector. A connector connects to the water unit and a connector connects to the peritoneal dialysis machine.

At least one of these connectors contains the o.g. Information that represents or allows conclusions to be drawn about the amount of water to be added to the concentrate container. This information may e.g. be arranged in the form of a barcode on the connector or in the form of another code that is readable. The water unit and / or the Peritonealdialysegerät contain at least one receptacle for receiving this connector and reading means which are adapted to read the information located on the connector.

If the water unit contains this receptacle and the connector is inserted there, the water unit can immediately supply the desired amount of water and dose it into the concentrate container.

If the peritoneal dialysis device contains this receptacle and the connector is inserted there, the peritoneal dialysis device transmits the information to the water unit so that it can provide the desired amount of water and dose it into the concentrate container.

In an alternative embodiment, it is also conceivable that the dosage of the amount of water is carried out by the peritoneal dialysis machine.

The other connector may also be such a connector provided with an information or even a standard connector that contains no information. However, the other connector may also be a connector that contains information, eg in form a barcode or in the form of another code. Both connectors can contain the same or different information.

Preferably, the concentrate container (s) has all the substances required for peritoneal dialysis which, after dilution with water, are present in the desired concentration, the substances comprising the following group: electrolyte ions and at least one osmoticum, in particular glucose and optionally one or more buffers. The concentrate or concentrates may be concentrated solutions as well as dry concentrates.

The peritoneal dialysis machine and / or the water unit can have a plurality of receptacles for connectors of different concentrate containers and / or the peritoneal dialysis machine can have at least one receptacle for a connector for a prefilled solution container.

If several recordings are available, several concentrate containers can be connected and filled one after the other or simultaneously with water. The concentrate containers may contain identical or different concentrates.

It is also conceivable that at least one receptacle for a standard connector of a finished solution container is present, so that even such solution container already containing dialysis solution can be connected.

The concentrate container or containers may have a first tube, by means of which water can be fed into the concentrate container from the water unit and have a second tube, by means of which the concentrate produced in the concentrate container can be fed to the peritoneal dialysis machine. The first tube can be provided with a code containing the information about the amount of water to be added, in particular a barcode, and introduced into the water unit, the other tube can be made with a standard connector which is connected to the peritoneal dialysis machine. This too However, hose can be provided with a connector with information, eg about the type and amount of the solution.

However, it is also conceivable that the concentrate container (s) have only a single tube, by means of which water can be admitted into the concentrate container by the water unit and by means of which the concentrate produced in the concentrate container can be fed to the peritoneal dialysis machine.

Furthermore, it is conceivable that the concentrate container (s) have at least one hose by means of which water can be admitted into the concentrate container by the water unit, wherein at least one filter and / or at least one one-way valve is located in this hose. The filter causes further purification of the water by which the concentrate is diluted, the one-way valve ensures that no fluid from the Konzentratbehalter flows back to the water unit, but only in the opposite direction.

The filter and / or the one-way valve may be considered disposable, i. be designed as disposable article.

The peritoneal dialysis machine may comprise at least one receptacle for the connector having the information, and the peritoneal dialysis apparatus may further comprise transmission means for transmitting this information to the water unit. This is necessary when the connector is inserted into the peritoneal dialysis machine but not into the water unit. In this case, it is possible to dispense with receptacles for connectors and a readout unit of the connector information in the water unit.

These transmission means may be configured to transmit the information by wire or wireless. The connector or connectors may have one or more information about the type of concentrate, in particular about the ingredients and / or their concentrations.

The concentrate (s) may be in liquid or solid form in the concentrate container (s).

The water unit may have at least one pump to be balanced. This introduces water in the desired amount into the concentrate container (s).

Instead of a pump, any other dosage unit may be provided which doses water preferably with an accuracy of 1%.

The water unit and / or the Peritonealdialysegerät can be arranged on a movable frame or trolley or in a container that also serves as a base for the peritoneal dialysis machine.

Preferably, the peritoneal dialysis machine is an APD device, but any other peritoneal dialysis devices are also usable within the scope of the invention.

If several concentrate containers are connected, they can have identical or different volumes.

In principle, it can be provided that the volume of the concentrate container represents information which is likewise contained in the code, in particular the bar code of the connector. Exemplary volumes are 2 I, 5 I or 15 I if only one bag is to be used for the entire therapy.

For example, the water unit may be connected to a platform and / or the peritoneal dialysis machine wirelessly, via WIFI, Bluetooth, or other techniques. It is also possible that at least one balance is provided for detecting the weight of the concentrate container and that communication means for communication between the balance and the water unit are present, via which the information about the current weight of the concentrate container can be transmitted to the water unit. So it is possible to use a non-balancing pump. In this case, the filling volume in the concentrate container is defined by a balance. It is conceivable that the balance or another unit connected to it controls a valve which blocks or releases the flow path into the concentrate container, depending on whether the desired volume or weight has already been reached in the concentrate container. Thus, it is also possible to make or verify several concentrate containers in succession.

In one embodiment, it is provided that the peritoneal dialysis machine has at least one memory in which the prescription to be made is stored for the treatment. Based on the prescription, the peritoneal dialysis machine determines which concentrate containers to attach to the water unit. The water unit reads from the bar codes or other codes the information on the amount of volume to be used for diluting the concentrates and makes the appropriate filling of the concentrate container (s).

The water unit may include means configured to give a timestamp indicating when the solution has been completely diluted. This timestamp is communicated via a connection (eg WLAN or LAN) to the peritoneal dialysis machine. The peritoneal dialysis machine verifies that the timestamp is still valid, ie, that it has not been too long since the solution was prepared, and only allows the solution to be treated if the time has not yet passed. Typical values are in the range of 6 and 24 h. For better mixing of the solutions, at least one movement element, such as eg a shaker, can be provided in order to move the concentrate container or containers.

Alternatively or additionally, it is possible to apply pressure surges when filling the concentrate container in order to ensure better mixing.

The alternating use of suction and filling phases is possible.

The present invention further relates to a concentrate container containing a concentrate which is used after dilution for use as a solution for peritoneal dialysis, wherein the concentrate container has at least one connector having one or more information, preferably in the form of at least one barcode, which Represents the amount of water to be filled into the concentrate container or allows conclusions to be drawn. The concentrate container may for example have one or two tubes. In the case of two hoses, each hose may be provided with a connector having information, or only one of the connectors, as detailed above.

The present invention further relates to a process for the preparation of a peritoneal dialysis solution, which preparation is carried out using a peritone aldialysis system according to one of claims 1 to 12.

Preferably, the method is carried out such that it comprises the step of inserting the at least one connector into the water unit and / or into the peritoneal dialysis apparatus, that the information located on the connector is read out, and that the addition of water into the concentrate container (s) corresponding to read information takes place.

Further details and advantages of the invention will be explained in more detail with reference to an embodiment shown in the drawing. Show it:

FIG. 1: a schematic view of the peritoneal dialysis system with two each

Hoses with connector per bag,

FIG. 2 shows a schematic view of the peritoneal dialysis system with one each

Hose with connector per bag and

FIG. 3 is a schematic view of the peritoneal dialysis system with trolley;

FIG. 1 shows a peritoneal dialysis system according to the invention in a first embodiment.

The reference numeral 10 denotes the water unit, which has means for dosing and means for treating or purifying the water.

The water unit 10 is connected to the faucet 1 of a household or clinic, etc.

The reference numeral 20 denotes a peritoneal dialysis apparatus, the reference character P denotes a patient whose prescription is stored in the peritoneal dialysis apparatus 20.

Reference numerals 30 and 31 designate two concentrate containers of different sizes with the concentrates K30 and K31, the concentrate container 30 having a volume of 15 l and the concentrate container 31 having a volume of 5 l.

Both are prefilled with a concentrate K30, K31, which is diluted with water from unit 10. As can be seen from FIG. 1, each of these concentrate containers 30, 31 has a first tube S1 with a first connector K1 and a second tube S2 with a second connector K2, the tubes S1 for supplying water from the unit 10 into the bags 30, 31 and the tubes S2 serve to remove the diluted concentrate or the finished dialysis solution from the bags 30, 31 to the peritoneal dialysis machine 20. In the tubes S1 is in each case a disposable ultrapure filter 1 1.

The connectors K1 and K2 each contain bar codes B1 and B2.

The barcodes B1 contain information that allows conclusions about what volume or mass of water is to be filled in the bags 30, 31. The water unit 10 reads this information and doses a corresponding amount of water into the bags, so that the desired concentration of the individual substances is present in the bags.

Once this is the case, the solution can be used for use in the peritoneal dialysis machine 20. The solution is read by the peritoneal dialysis machine 20 from the barcode B2 of the connector K2.

By the present invention, it is possible to dispense with the delivery of solution bags containing the final dialysis solution. Rather, it is sufficient to provide concentrate bags or containers whose contents are then diluted on site to the desired concentrations.

The peritoneal dialysis machine 20 also has one or more receptacles for standard connectors, so that a ready-filled standard solution bag 33 can be connected and used, as shown in FIG.

FIG. 2 shows an exemplary embodiment in which the concentrate containers have only one tube S3 which is designed with a connector K3 with barcode B3 is. Incidentally, the same or functionally identical parts are denoted by the same reference numerals as in FIG. 1.

The connector K3 is inserted into a receptacle of the peritoneal dialysis machine 20 and thus does not communicate directly with the water unit 10.

The water unit 10 comprises a pre-filter and RO unit 1 1, a pump, such as a pump. an impeller pump 12 and this downstream filter 13. The water unit 10 is connected via a hose 40 or other line with the peritoneal dialysis machine 20 in connection. In this tube 40 is another filter 41, e.g. a 0.2 μ filter.

The peritoneal dialysis machine 20 reads out the bar codes B3 and reports to the water unit 10 which amount of water is to be metered. The water unit 10 delivers this amount of water to the peritoneal dialysis machine 20 and this or into the concentrate containers 30, 31. After dilution and dissolution in the concentrate containers 30, 31, the solution is delivered to or from the peritoneal dialysis machine, for example. promoted by one or more pumps to the patient. Reference numeral 60 denotes a safety chamber in the concentrate container 30.

The barcodes B1 and B3 have information indicating the type of solution or concentrate to be prepared and the amount of water to be added. Despite the same reference numbers B1, the barcode B1 of the bag 30 may have information different from the barcode B1 of the bag 31 , This applies to the bar codes B2 and B3 accordingly.

The peritoneal dialysis system can be used as a batch-type system, which produces the solutions batch-wise for the respective treatment.

It is conceivable to move the peritoneal dialysis machine or the peritoneal dialysis system as a whole to the patient. The peritoneal dialysis machine can be moved on a trolley T from a filling station or from the water unit to the patient.

FIG. 3 a) shows the peritoneal dialysis machine 20 and the water unit as a movable peritoneal dialysis system, with the peritoneal dialysis machine 20 standing on top of the water unit 10.

FIG. 3 b) shows the peritoneal dialysis machine 20 on a trolley T and independent of the water unit 10, which in this case is designed as a separate unit separate from the peritoneal dialysis machine 20.

Claims

Fresenius Medical Care Germany GmbH

61352 Bad Homburg

Peritoneal! ialysesystem

claims

Peritoneal! at least one peritoneal dialysis machine, characterized in that the peritoneal dialysis system further comprises at least one water unit for treating and / or metering water and at least one concentrate container, wherein the concentrate container has at least one connector or is in communication therewith and wherein the water unit and / or or the peritoneal dialyzer has at least one receptacle for the connector, wherein the connector has at least one information, preferably in the form of at least one barcode, which represents or allows conclusions about the amount of water to be introduced into the concentrate container, and wherein the water unit or the peritoneal dialysis machine is formed is to read this information and make the addition of water according to the information read or cause.

2. Peritoneal! ialysesystem according to claim 1, characterized in that it is the Konzentratbehalter to a concentrate bag and / or that at the Konzentratbehalter is at least one tube, at the end of the connector is arranged.

3. peritoneal dialysis system according to claim 1 or 2, characterized in that the Konzentratbehalter has at least two connectors or in connection with these, wherein at least one of the connectors containing said information and the other connector the same or another information and wherein both the Peritonealdialysegerät than Also, the water unit has at least one receptacle for each one of these connectors.

4. Peritoneal dialysis system according to one of the preceding claims, characterized in that the concentrate container (s) has all the substances required for peritoneal dialysis which are present after dilution with water in the desired concentration, the substances comprising the following group: electrolyte ions and at least one osmoticum, especially glucose.

5. peritoneal dialysis system according to one of the preceding claims, characterized in that the peritoneal dialyzer and / or the water unit have multiple receptacles for connectors of different concentrate containers and / or that the peritoneal dialysis device has at least one receptacle for a connector for a prefilled solution container.

6. peritoneal dialysis system according to any one of the preceding claims, characterized in that the or the concentrate container having a first tube, by means of which water in the concentrate container of the water unit is zugebbar and have a second tube, by means of which the concentrate prepared in the concentrate container the peritoneal dialyzer or that the concentrate container or containers only have a hose, by means of which water in the concentrate container of the water unit can be assigned and by means of which the concentrate prepared in the concentrate container is the peritoneal dialysis machine supplied.

7. Peritoneal dialysis system according to one of the preceding claims, characterized in that the concentrate container or containers have at least one tube by means of which water in the concentrate container of the water unit is zugebbar, wherein in this tube at least one filter and / or at least one one-way valve.

8. Peritoneal dialysis system according to one of the preceding claims, characterized in that the Peritonealdialysegerät comprises at least one receptacle for the connector having the information and the Peritonealdialysegerät further comprises transmission means to transmit this information to the water unit.

9. peritoneal dialysis system according to claim 8, characterized in that the transmission means are adapted to transmit the information wired or wireless.

10. peritoneal dialysis system according to one of the preceding claims, characterized in that the one or more connectors one or more information about the type of concentrate, in particular on the ingredients and / or their concentrations.

1 1. Peritoneal dialysis system according to one of the preceding claims, characterized in that the water unit has at least one balancing pump and / or that at least one balance is provided for detecting the weight of the concentrate container and that Communication means for communication between the balance and the water unit are present, via which the information about the current weight of the concentrate container to the water unit is transferable.

12. peritoneal dialysis system according to any one of the preceding claims, characterized in that at least one moving element is provided to move the concentrate container for better dissolution of the concentrate and / or that means for generating pressure surges in the concentrate container are present.

A concentrate container containing a concentrate used after dilution for use as a solution for peritoneal dialysis, wherein the concentrate container has at least one connector having one or more information, preferably in the form of at least one barcode, which measures the amount of the concentrate into the concentrate container represents water to be filled or allows conclusions on it.

14. A process for the preparation of a peritoneal dialysis solution, characterized in that the preparation using a peritoneal dialysis system according to one of claims 1 to 12 takes place.

15. The method according to claim 14, characterized in that the method comprises the step of introducing the at least one connector into the water unit and / or in the Peritonealdialysegerät that the information located on the connector information is read and that the addition of water in the concentrate container takes place according to the information read out.