DE102014017897A1 - peritoneal dialysis - Google Patents

Abstract

The present invention relates to a peritoneal dialysis machine which has a modular design and comprises a base module and one or more extension modules connected to the base module, the base module having a pump system, the flow path control and a cartridge for at least one fluid channel having at least one expansion module a receiving area for receiving a solution bag, and wherein the expansion module is in communication with the base module such that a fluid connection can be made from a solution bag located in the receptacle to a cassette located in the loading device.

Description

The present invention relates to a peritoneal dialysis machine with a pump system, a flow path control and a loading device for a cassette for guiding the dialysis solution.

According to the state of the art, peritoneal dialysis apparatuses, in addition to the pump system for pumping the dialysis solution, the flow path control for conducting the dialysis solution to and from the patient, for drainage, etc., as well as the cassette inserting apparatus, have all the modules or functional units necessary for satisfying the patient's needs. which can be individually different, are executed. In known devices, all properties or functionalities required for carrying out a peritoneal dialysis treatment are implemented in the device.

The provision of peritoneal dialysis machines with all the functionalities that could be required in the course of a treatment, while offering the advantage that in principle all occurring in the context of treatment patient needs can be met. However, this "maximum equipment" of a peritoneal dialysis machine has the disadvantage that the equipment costs are comparatively high due to the equipment.

The present invention is therefore based on the object to further develop a peritoneal dialysis device of the type mentioned in that this can be carried out inexpensively and nevertheless meets all the requirements of individual patient treatment.

This object is achieved by a peritoneal dialysis machine having the features of claim 1. Thereafter, it is provided that the peritoneal dialysis machine has a modular design and comprises a basic module and one or more expansion modules connected to the base module, the basic module having the pump system, the flow path control and the insertion device for a cassette having at least one fluid channel. Furthermore, the at least one expansion module has a receiving area for receiving a solution bag and is connected to the base module in such a way that a fluid connection can be established between the solution bag and the cassette.

The modular peritoneal dialysis machine makes it possible to provide the patient with only as many device components and disposable items as are required individually. For this purpose, the entire device is subdivided into different units or modules, which can be combined or stacked modularly to form an overall machine.

The base module includes a pump system that includes a pump or actuator that acts on a pump chamber of the loaded cartridge. Furthermore, the basic module has the complete fluid control including the flow path control. This can have one and preferably a plurality of valves or actuators, which act on channels of the inserted cassette and release, shut off or throttle them.

The basic module preferably has an evaluation, storage and display unit and preferably a control or regulating unit which controls or regulates the components of the peritoneal dialysis machine and / or its entire operation.

The basic module further includes an insertion device for the cassette and possibly a heater z. B. in the form of a hot plate for heating a solution bag. The heating device or heating plate may alternatively or additionally preferably be arranged in the first expansion module.

In principle, one, several or all expansion modules can be equipped with a heating device or heating plate for heating the solution bags.

It should be noted that the term "a" or "an" is not to be construed as limiting that such an element exists. On the contrary, the presence of several components, such as, for example, a plurality of pump systems, fluid controllers, solution bags, extension modules, etc., is to be understood by the invention.

From the prior art, no modular peritoneal dialysis device according to the invention is known. The WO 2011/069110 A1 discloses a modular dialysis system whose individual modules together form the overall system. The individual modules consist for example of the water treatment module and a module for performing the treatment and an interface module that forms the interface to the user. The US 5,609,572 discloses a cash infusion system that consists of multiple components or modules that can be assembled in a modular manner. The US 2009/0008306 A1 discloses a modular system for combining hemodialysis and peritoneal dialysis treatment. From the EP 2 319 551 A2 is a portable hemodialysis known, to the modular other devices can be connected. None of these References disclose a peritoneal dialysis apparatus according to the present invention.

In a preferred embodiment of the invention it is provided that the device has a plurality of expansion modules, which are constructed identically.

The number of expansion modules that will be used depends on the particular requirements of the treatment.

The expansion module (s) are preferably detachable from and connectable to the base module. Preferably, this release and connection can be made by a user (patient or staff), so that it is relatively easy to assemble an overall device that is tailored to the individual needs of the patient.

If a plurality of expansion modules are provided, these are preferably of identical construction. However, the invention fundamentally also encompasses the case in which the several extension modules are constructed differently (eg at least one with heating device or balance and at least one without these components).

It is preferably provided that the expansion module (s) are located above the basic module and / or that a plurality of expansion modules arranged one above the other are provided. With this arrangement, it is possible to supply the base module or a heating bag positioned thereon with liquid during the entire course of the treatment.

In a further embodiment of the invention, it is provided that the basic module has an evaluation, storage and / or display unit.

Furthermore, it can be provided that a balance is present, which is preferably arranged in at least one expansion module. This balance may alternatively or in addition to a heater such. B. a heating plate may be arranged in the expansion module.

The balance may be needed as a reference to the pump of the basic module for volume balancing and / or for the production of a mixed solution of different solution bags. In principle, it is conceivable that exactly one scale is provided, but it is also possible to arrange several scales (possibly in several expansion modules), which can be used, for example, to produce a mixed solution from the different contents containing solution bags.

In a preferred embodiment of the invention it is provided that the expansion module or modules are designed as drawers or have a drawer. The expansion modules can also be designed as simple receptacles, which have at least one open side, which can be closed by a flap or the like.

It is preferably provided that the expansion module or modules are surrounded on all sides by walls, wherein at least one wall is movable such that a solution bag can be inserted or removed.

The walls are preferably thermally insulated to minimize heat loss to the environment.

As stated above, the expansion module or modules may have at least one flap for thermal insulation of the receiving area of the expansion modules. Basically, the expansion modules all or at least a plurality of these serve to accommodate a solution bag, d. H. they represent the (preferably exclusive) storage location for the dialysis fluid. It is also possible that the base module has a heating plate or another heating device, which makes it possible to heat a first heating bag.

Due to the expansion modules, it is possible to expand the basic module in any number or extent. It is also preferably possible to connect an expansion module during a current treatment, if necessary.

Said flap can be designed to allow higher heating temperatures, which improves performance of the peritoneal dialysis machine. The flap or an insulating material of the expansion module allows a reduction of the waste heat and the improvement of the energy balance.

As stated above, it is conceivable and advantageous for the expansion module (s) and / or the basic module to have a heating device, such as a heating plate for heating the solution bag respectively arranged on the basic module or in the expansion modules.

Additional heating in the expansion module can improve the performance data (heating time, ambient temperature).

In a further embodiment of the invention it is provided that the expansion module or modules have at least one valve which is arranged so that in the receiving area of the expansion module inserted or inserted solution bag can be shut off and opened. In the closed state, there is no fluid connection to the cassette, in the opened state the dialysis solution can run out of the solution bag into the cassette.

It should be noted at this point that the present invention uses the peritoneal dialysis machine as such, i. H. without cassette, tubing and solution bags, but also relates to a peritoneal dialysis machine in which these components are used so that the peritoneal dialysis machine is ready for use.

In a further embodiment of the invention it is provided that the device has a patient line, a drainage line and a solution bag line or can be equipped with these lines and that said flow path control of the basic module is designed so that the compounds cassette patient line, cassette drainage line and Cassette solution bag line are feasible. As stated above, the cassette preferably comprises a pumping chamber and fluid channels.

In a further embodiment of the invention, it is provided that the expansion module or modules are provided with a coding means, wherein the coding means are characteristic of the solution bag which can be inserted into the expansion module or inserted therein.

Preferably, therefore, the expansion modules are each with a coding z. B. marked with a colored sticker or the like. The patient inserts the appropriate solution bags into the expansion modules marked in this way. The individual drawers or extension modules are preferably connected electronically or otherwise to the basic module so that it can capture the equipment (eg the bag size, the type of solution, the concentration, etc.) of the drawers or extension modules by means of the coding.

With a coding for the last filling, which remains in the patient until the next treatment, a "last bag option" can also be easily integrated and recognized.

It is preferably provided that the flow path control of the basic module is designed so that it carries out the control of the flow paths as a function of the detected coding.

Thus, it is possible, for example, to activate different valve groups as a function of the coding and thus, for example, to administer different solutions at different times.

Thus, it is also possible, for example, that a profiled treatment is feasible. This is a treatment in which the treatment parameters are variable over time. Thus, for example, a small volume of highly concentrated glucose-containing solution can be administered with a short residence time and at a different treatment time a low-concentration glucose solution with a longer residence time, etc.

By means of a control or regulation unit of the device, which accesses the flow path control and the pump, it is thus possible to perform a dialysis treatment with different therapy models, such as IPD, NIPD, Tidal PD and CCPD. If a CCPD treatment is preceded by a change in dialysate during the day before the patient starts his or her actual activity in the evening, this is called a PD-Plus therapy.

By means of the peritoneal dialysis apparatus according to the invention is also a so-called adapted APD (aAPD), d. H. to realize a so-called profiled treatment. Thus, it is conceivable, for example, that a change between different solution bags or glucose concentration, dwell time and filling volume can be selectively controlled and set using the coding.

In a further embodiment of the invention, at least two expansion modules are provided, which are connected to each other at least by a riser and with the base module or with the cassette arranged thereon. Preferably, it is provided that the riser consists of individual line sections, preferably of T-shaped line sections, one leg of which are connected to the solution bag and lying in a line leg with each adjacent T-shaped line sections.

It is thus preferred if the solution or dialysate bag have a hose connection, which is in each case designed as a T-piece, so that they can be connected to each other and in any order with the cassette of the basic module. By connecting a plurality of solution bags in the form of a riser, it is possible that only a single Dialysatfluidverbindung is required for the cassette.

Preferably, the entire cartridge system in this case has only three hose connections on, namely, the fluid line connecting the solution bags to the cassette, the drainage line connecting the cassette to the drain, and the patient line connecting the cassette to the patient. It is also conceivable that the solution bags can be used as a drainage bag in the next treatment.

In addition, a small drainage bag can also be provided, which can receive the ultrafiltrate and, if necessary, can be connected to the drainage bag via the T-piece connection.

In a further embodiment of the invention it is provided that the dialysis machine has means by which a mixed solution of several individual solutions or concentrates can be produced. These means may include valves, pumps, etc., and a control unit which controls the valves or pumps etc. in such a way that the desired mixed solution is produced.

It is conceivable that at least one of the expansion modules has a bag which serves for the preparation of the mixed solution. In this bag, for example, a first solution or a (solid or liquid) concentrate may be present and one or more (further) solutions may be added from other solution bags, which are preferably arranged in other extension modules.

It is also conceivable that the bag which serves to prepare the mixed solution is initially introduced as an empty bag and the mixture is obtained by passing solutions from various other solution bags into this empty bag.

In the expansion module, which has the bag for the preparation of the mixed solution, it is in the case of several superimposed expansion modules is preferably the lowest. This has the advantage that due to gravity alone an inflow of solutions or components of solution into the bag for the production of a mixed solution takes place. In principle, it is also conceivable to arrange the bag for producing the mixed solution in one or more other expansion modules and / or to use a pump for conveying the solutions or solution components.

The control of which solution is added to the mixing bag when may be via one or more valves that shut off or open the lines between the bags accordingly. The valves can in turn be controlled by a control unit of the device.

It is conceivable that the user indicates the desired amount and / or composition of the mixed solution by means of an input device and that the device then produces the desired mixture by the switching of valves, pumps or the like.

Preferably, at least in the expansion module, which comprises the bag for producing a mixed solution, a balance for balancing, by means of which the bag weight can be detected.

It should be noted that the term "bag" or "solution bag" used in the context of the invention is representative of any container which is suitable for receiving a solution. This container may for example have solid or rigid or flexible walls.

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

The single drawing shows a schematic representation of a Peritonealdialysegerätes according to the invention.

The peritoneal dialysis apparatus shown in the figure consists in the embodiment shown here of three modules, namely the basic module 10 and the expansion module 20 and 30 , The basic module 10 includes the pumping system 14 and the recording for the cassette 12 and the flow path control in the form of the valves V1, V2 and V3.

The pumping system 14 is used for volume balancing, air detection and fluid handling. The pumping system 14 acts on the pumping chamber of the cassette 12 a promotion of the dialysis solution in the cassette is effected.

With the reference number 100 is a lead from the cassette 12 to the patient P, with the reference numeral 200 a lead from the cassette 12 to the drainage D and by the reference numeral 300 a line from the solution bags 22 . 32 or from the expansion modules 20 . 30 to the cassette 12 characterized.

The flow path control in the form of the valves V1, V2, V3 allows a connection between the pumping chamber of the cassette 12 to the patient management 100 , from the pump chamber of the cassette 12 to the drainage and from the pumping chamber of the cassette 12 to the solution bag (s) 22 . 32 build.

In a conceivable embodiment of the invention, the base module has a heating plate, which makes it possible to heat a first solution bag.

In a preferred embodiment of the invention, it is provided that the basic module has no heating device, but only one or more of the expansion modules. It is conceivable, in principle, that the first expansion module, i. H. the subsequent to the basic module extension module a heater z. B. in the form of a hot plate. The further expansion modules can be designed without a heating device for the solutions, but in principle also be equipped with such a heating device.

The basic module and / or the expansion module also has the possibility of measuring the temperature of the heated dialysis solution.

As stated above, the expansion modules are used 20 . 30 as a storage location for the liquid bag 22 . 32 in which the dialysis solution is located.

Another capability of these modules 20 . 30 is the solution bag 22 . 32 by means of a valve V4, V5 with the basic module 10 or with the cassette 12 connect to.

As can be seen from the figure, the expansion modules 20 . 30 above the basic module 10 positioned, thereby it is possible, during the entire course of treatment, the heating bag of the basic module 10 with liquid from the solution bags 22 . 32 to supply.

The illustrated peritoneal dialysis machine furthermore has one with the basic module 10 related display unit 40 on.

The disposable article of the illustrated Peritionealdialsygerätes consists of two main components in the form of the cassette 12 with patient management 100 and drainage line 200 (and possibly solution line 300 ) and the prescription number of solution bags 22 . 32 ,

The cassette 12 The task is to shape the pump chamber, to provide the flow paths between the patient, the heating bag and the drainage, to provide the valve seats and to connect the heating bag, the drainage and the patient.

As a heating bag in this context, the bag in the expansion module 20 understood that about a bag heater 24 is heated.

In principle, it is conceivable that a bag heater is arranged only in an expansion module. However, the invention also includes the case that each or several expansion modules 20 . 30 each have at least one bag heater.

As will be seen further from the figure, the solution bags 22 . 32 a connection in the form of a tee, which in the figure by the reference numeral 25 . 35 is provided. Through the illustrated connection 5 the individual tees create a riser 300 from which the individual solution bags 22 . 32 branch. As can be seen from the figure, this branch can be closed or opened with the hose valve V4, V5 installed in the expansion module. As can be seen from the figure, the first, ie the lowest solution bag 22 used as a heating bag and with the pump connection of the cassette 12 connected.

The individual T-pieces are in each case with the valve V4 and V5 and with the adjacent T-piece or to the cassette 12 leading line section.

As an extension, the extension module can be equipped with an additional heater, which improves the performance data in terms of the heating time and the ambient temperature. The expansion module can be equipped with a flap to allow a higher heating temperature. This also improves the performance data. The flap or the insulating material of the expansion module allows in the reduction of waste heat and thus an improvement in the energy balance of the entire peritoneal dialysis machine.

The entire expansion module preferably has walls of a heat-insulating material.

As stated above, each or at least one and preferably a plurality of expansion modules may be provided with a coding system that allows a functionality or a solution type to be assigned to the or each expansion module. One conceivable type of coding is a badge that can be attached to the expansion module. However, any other type of coding is also covered by the invention.

The coding points to the bag valve V4, V5 of the extension module 20 . 30 the corresponding valve group of the basic module 10 to. During the course of treatment, the basic module activates the different valve groups depending on the coding of the expansion modules. For example, it is conceivable that coding by solution type (eg 1.5%, 2.3%, 4.75%) or after To design the time of use (last bag option).

The simplicity of coding by a colored badge or the like allows operation by non-technically trained staff and a test can be done by the patient or the treatment can be adjusted. The coding can be determined by reading back through the basic module. For this purpose, the basic module z. B. an electronic connection with the expansion modules in connection. Preferably, the individual drawers or expansion modules are electronically connected to the base module, so that this can recognize the assembly of drawers or expansion modules by means of the coding. However, the invention also encompasses any other type of transmission of the coding to the basic module.

As can be seen from the figure, it is by connecting a plurality of solution bags 22 . 32 in the form of a riser 300 possible for the cassette 12 only a single dialysate fluid connection is required and not a separate connection for each solution bag. Thus, the entire cassette system can preferably manage with only three hose connections (fluid line, drainage line, patient line).

By the present invention, it is possible to provide a cost-effective treatment by being able to assemble a peritoneal dialysis apparatus as required by the individual needs of the patient. On a maximum equipment of all Peritonealdialysegeräte can be dispensed with.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• WO 2011/069110 A1 [0012]
• US 5609572 [0012]
• US 2009/0008306 A1 [0012]
• EP 2319551 A2 [0012]

Claims (15)

Peritoneal dialysis machine with a pump system, a flow path control and a loading device for a cassette for guiding the dialysis solution, characterized in that the peritoneal dialyzer is modular and comprises a base module and one or more extension modules connected to the base module, wherein the base module, the pump system, the flow path control and the insertion device, wherein the at least one expansion module has a receiving area for receiving a solution bag and wherein the expansion module is in communication with the base module such that a fluid connection can be made from a solution bag located in the receptacle to a cassette located in the insertion device. Peritoneal dialysis apparatus according to claim 1, characterized in that the device has a plurality of expansion modules, which are constructed identically, and / or that the one or more expansion modules are designed such that they can be removed from the base module and coupled to the basic module. Peritoneal dialysis apparatus according to claim 1 or 2, characterized in that the one or more expansion modules is located above the base module and / or that a plurality of superposed expansion modules are provided. Peritoneal dialysis apparatus according to one of the preceding claims, characterized in that the basic module has an evaluation, storage and / or display unit. Peritoneal dialysis apparatus according to one of the preceding claims, characterized in that a balance is provided, which is preferably arranged in at least one expansion module. Peritoneal dialysis machine according to one of the preceding claims, characterized in that the expansion module or modules are designed as drawers or have a drawer and / or that the expansion module or modules have at least one flap for heat insulation of the receiving area for the solution bag. Peritoneal dialysis apparatus according to one of the preceding claims, characterized in that the expansion module (s) and / or the basic module have a heating device for heating the solution bag (s). Peritoneal dialysis apparatus according to one of the preceding claims, characterized in that the expansion module or modules have a valve which is arranged such that a solution bag located in the receiving region of the expansion module can be shut off and opened. Peritoneal dialysis apparatus according to one of the preceding claims, characterized in that the peritoneal dialysis device has a patient line, a drainage line and a solution bag line or can be equipped with these lines and that the flow path control is designed such that the following compounds are constructible: cassette - patient line, cassette - drainage line and cassette solution bag line. Peritoneal dialysis machine according to one of the preceding claims, characterized in that the expansion module or modules are provided with a coding means, wherein the coding means are characteristic of the insertable into the expansion module or inserted solution bag. Peritoneal dialysis apparatus according to claim 10, characterized in that the basic module is so preferably electronically connected to the expansion module or preferably electronically connected, that the coding is detected by the basic module, wherein it is preferably provided that the Flußwegesteuerung the basic module is formed in that it carries out the control of the flow paths as a function of the detected coding. Peritoneal dialysis machine according to one of the preceding claims, characterized in that the flow path control of the basic module is designed such that a profiled treatment is feasible. Peritoneal dialysis apparatus according to one of the preceding claims, characterized in that at least two expansion modules are provided and that at least one riser is provided, which establishes a fluid connection between the expansion modules with each other and with the base module, wherein preferably exactly one such riser is provided. Peritoneal dialysis apparatus according to claim 13, characterized in that the riser consists of individual line sections, preferably T-shaped line sections, which are connectable to the accommodating in the expansion modules solution bags. Peritoneal dialysis machine according to one of the preceding claims, characterized in that the device comprises means which are designed such that in at least one expansion module, a mixed solution can be produced, which consists of at least two individual components or solutions, wherein it is preferably provided that the means or a plurality of valves and / or pumps and a control or regulating unit which control or regulate the valves or pumps depending on the desired composition of the mixed solution.

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