System for preparing a medical fluid

ES 2 659 983 T3

DESCRIPTION

Medical fluid preparation system

The present invention is directed to a medical fluid preparation concentrate container, a medical fluid preparation system, a fluid container system, a kit of parts for the preparation of a medical fluid, a use of a medical fluid preparation system, and a medical fluid preparation method. In particular, the medical fluid preparation concentrate container, the medical fluid preparation system, the fluid container system, the medical fluid preparation parts kit, and the medical fluid preparation method. it can be used in dialysis, eg acute dialysis, or in hemodiafiltration.

Typically, patients with chronic kidney failure receive medical treatment three to four times a week, either in a dialysis clinic or at home. During hemodialysis, a dialysis machine pumps blood from a vascular access in the patient into a dialyzer. The dialyzer filters the waste products of metabolism and removes excess water from the blood. These waste products are then rinsed with dialysis solution and the filtered blood is returned to the patient's body. During hemodiafiltration, the machine removes more water from the blood than during hemodialysis. The additional liquid is continuously replaced with an ultra-pure electrolyte solution. Thus, the machine exchanges a high volume of fluid during the treatment and removes the fluid along with metabolic toxins from the blood.

In peritoneal dialysis, the patient's peritoneum acts as a filter to clean the blood. The peritoneum has characteristics similar to those of the dialyser: pores in the membrane allow the passage of certain substances while preserving others. A catheter is used to introduce dialysis solution into the abdominal cavity. The blood-rich peritoneum is surrounded by the dialysis solution and metabolic toxins flow from the blood through pores in the peritoneum in the dialysis solution. Also, the glucose in the dialysis solution draws excess water out of the body. The solution containing the toxins and excess water is removed through the catheter and replaced with fresh solution. In continuous ambulatory peritoneal dialysis (CAPD), patients change the dialysis solution with the help of bag systems four to five times a day. In automatic peritoneal dialysis (APD), a dialysis machine (cycler) takes over the exchange of fluids, making overnight treatment possible.

Usually dialysis systems for patients with chronic kidney failure are provided with a separate system, in order to supply reverse osmosis water (RO water), fresh or concentrated dialysis solution for dialysis solution to the dialysis machine . However, these systems are not feasible for intensive care in hospitals, as intensive care dialysis machines are used at irregular time intervals and in different locations. Therefore, previous developments aimed at providing dialysis machines with a huge reserve of dialysis solution, so that the dialysis machines can be used in separate locations at any time. Such reservoirs may be provided with an internal container, in order to accommodate the dialysis solution. Preferably, the inner container is a bag or sack that has a high volume and that can be disposed after the dialysis treatment. If disposable materials are used, the time spent disinfecting the tank can be omitted.

The use of bags for the storage of a large volume of dialysis solution is known. Previously, it was necessary to produce the dialysate contained in the bag in a separate device and transfer the dialysate produced in the bag for storage.

DE 10 2009 058 445 describes a bag for the preparation and formulation of a batch of dialysate having a high volume, the bag includes concentrate compartments.

AU 570 100 B2, DE 195 10 759 A1, US 4,386,634 A and DE 198 25 158 C1 disclose examples, in which a high volume of dialysate is provided in a storage container. The dialysate is contained in a bag having a high volume, which is supported by the storage container.

In DE 10 2007 009 269 A1 a glass tank is provided, in which the dialysate is stored.

EP 1 120 099 B1 describes a cartridge for accommodating concentrates, the cartridge having sub-compartments. The concentrates are dissolved by RO water.

DE 10 2010 014 785 refers to a plastic film that can be used for the production of a bag having a high capacity to accommodate a dialysate.

The object of the invention is to provide a device and a method for preparing a medical fluid.

In one example, a concentrate container for preparing a medical fluid is provided, preferably for preparing a dialysis solution, the concentrate container including at least two compartments of 2

ES 2 659 983 T3 concentrate, wherein at least one of the concentrate compartments has a medical fluid outlet, and at least one of the concentrate compartments has a diluent inlet.

In another example, there is provided a fluid container system for preparing a medical fluid, preferably for preparing a dialysis solution, including an arranged medical fluid collection fluid container, the fluid container having a drain line of medical fluid, and another fluid container for collecting a consumed medical fluid, the fluid container that can be inserted into the other fluid container.

A further example relates to a kit of parts for the preparation of a medical fluid, including at least two elements selected from a concentrate container according to a previous embodiment, a fluid container, a fluid container system according to the other embodiment above, and a transport means adapted to support and / or to include at least one of the concentrate container, the fluid container, and the fluid container system.

According to a further example, there is provided, a system for preparing a medical fluid, preferably for preparing a dialysis solution, the system including a concentrate container according to a previous embodiment, a fluid container fluidly connecting a medical fluid withdrawal line, at least one fluid transfer line fluidly connecting the at least one medical fluid outlet of the concentrate container and the fluid container.

According to still further example, the concentrate container, fluid container system, parts kit and / or medical fluid preparation system of above embodiments are used in dialysis, acute dialysis, hemodialysis, hemodiafiltration. , peritoneal dialysis, or preparation of a dialysis solution.

In another example, a method of preparing a medical fluid, preferably preparing a medical fluid in a system according to a prior embodiment, The method includes providing a concentrate container that includes at least one concentrate compartment, wherein a first compartment of the concentrate compartments contains a first concentrate; provide a diluent in the first compartment;

rinse the first compartment with the diluent and dilute the concentrate; and transferring the first diluted concentrate into a fluid container.

Some of the examples mentioned above will be described in more detail in the following description of typical embodiments with reference to the following drawings in which:

Figure 1a, 1b schematically illustrate containers of concentrate for preparing a medical fluid, according to embodiments of the invention;

Figures 2a, 2b schematically illustrate concentrate containers in accordance with embodiments of the invention;

Figure 3 schematically illustrates a concentrate container according to one embodiment of the invention;

Figure 4 schematically illustrates a concentrate container according to one embodiment of the invention;

Figure 5 schematically illustrates a concentrate container according to one embodiment of the invention;

Figure 6 schematically illustrates a concentrate container according to one embodiment of the invention;

Figure 7 schematically illustrates a system for preparing a medical fluid, according to an embodiment of the invention;

Figure 8 schematically illustrates a system for preparing a medical fluid, according to an embodiment of the invention;

Figure 9a schematically illustrates a system for preparing a medical fluid, according to an embodiment of the invention;

Figure 9b schematically illustrates a fluid container system for preparing a medical fluid, in accordance with one embodiment of the invention;

Figure 9c schematically illustrates a medical fluid preparation fluid container system, connected to a concentrate container, in accordance with one embodiment of the invention;

Figure 9d schematically illustrates a medical fluid preparation fluid container system, connected to a concentrate container, in accordance with one embodiment of the invention;

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Figures 10a, 10b schematically illustrate a system for preparing a medical fluid, according to an embodiment of the invention; Y

Figure 11 schematically illustrates a system for preparing a medical fluid, according to an embodiment of the invention.

Within the following description of the drawings, the same reference numbers refer to the same components. Generally, only differences with respect to individual embodiments are described. In the following description, embodiments of the invention are described with reference to a preparation of a dialysis solution, also referred to herein as a dialysate, without limiting the scope of the invention. Other medical fluids can be prepared using embodiments described herein. In addition, the terms concentrate compartment and compartment are used synonymously. On the other hand, in embodiments, a concentrate component can also be referred to as a concentrate.

The term "diluent" refers to fluids by which it concentrates, eg dry concentrates, can be diluted, dissolved or suspended. Some embodiments described in this document refer to a solvent as a diluent, but are not limited thereto. Furthermore, the embodiments described herein using the term diluent encompass examples in which at least two of the concentrate compartments of different diluents or solvents can be or are introduced. Furthermore, in some embodiments, the term diluent or dilution can encompass dissolution and / or suspension processes.

Figure 1A schematically illustrates a medical fluid preparation concentrate container 10, in accordance with one embodiment of the invention. The concentrate container 10 is in the present embodiment formed by four side walls 11 and a bottom wall 13. However, other spatial shapes of the concentrate container 10 can be contemplated. Two concentrate compartments 12 and 14 are formed within the container 10 by means of a barrier, which in the present embodiment is a partition wall 15 that partially divides the interior of the box into the two compartments 12 and 14. For example , the partition wall 15 may include an opening (not shown) for the passage of a fluid and solutes contained in the fluid. The Concentrate compartment 12 includes an opening 16 as the medical fluid outlet, while the concentrate compartment 14 is provided with an opening 18 that forms a solvent inlet as the diluent inlet. Since partition wall 15 allows fluids to pass from compartment 14 to compartment 12, a solvent loaded into compartment 14 through opening 18 can flow from compartment 14 into compartment 12, dissolving different concentrates contained in the different compartments and can exit the concentrate container 10 through the opening 16.

The concentrates can be filled into the different compartments through the top openings of the concentrate compartments shown in Figure 1a. In another example, the solvent inlets to the concentrate container 10 may simply be formed by the top openings of the concentrate compartments and an opening 18 is not provided.

Therefore, in one embodiment, a concentrate container for preparing a medical fluid, preferably for preparing a dialysis solution, includes at least two concentrate compartments, wherein at least one of the concentrate compartments has a fluid outlet. and at least one of the concentrate compartments has a diluent inlet. The compartments can be separated from each other in a permanent or semi-permanent manner. According to embodiments, the at least one medical fluid outlet and the at least one diluent inlet are separated from each other.

Embodiments of the invention allow a concentrate different from the concentrates in the other compartments to be loaded into each compartment and stored considerably apart from one another. As a result, the components are concentrated to form a medical fluid, such as dry concentrate components of a dialysate, they can be filled, transported and stored in a container with or without avoiding mixing the different components. This is especially useful for concentrate components that are susceptible to degradation and / or caking or that agglomerate when intermixed. Furthermore, the different concentrates or concentrate components can be dissolved or suspended using the concentrate container of the embodiments, thereby forming a medical fluid or partial fluids of a medical fluid directly in the concentrate container in which they are provided or stored. . Therefore, the dilution, suspension or dissolution of the concentrates or concentrate components can be carried out in different stages and / or in an efficient manner, even for bicarbonate granules. Furthermore, the concentrate container can be formed in a simple production process, by molding, and with only one disposable part.

Therefore, the concentrate container according to embodiments allows a physical separation between the dry concentrates, a dissolution of the concentrates in different stages with high efficiency, and an efficient waste disposal and can be formed by a simple production process. . On the other hand, using the concentrate container of the embodiments, a medical fluid can be prepared in situ in a container, where the concentrates can be stored and which can be directly coupled to a system for applying the medical fluid to a patient. Furthermore, by performing an appropriate dilution sequence 4

ES 2 659 983 T3 for the different concentrate components, degassing and precipitation of concentrate components during dilution can be reduced or avoided. Consequently, a complete dissolution of the concentrate components or concentrates contained in the concentrate container can be achieved, in order to form the medical fluid.

In other exemplary embodiments, the concentrate container has an angled or V-shaped interior surface. An example of a concentrate container that has an angled interior surface is one of the concentrate containers 10 to 30. Each of they have edges, which promote, during agitation of the concentrate container, the dissolution of the concentrates by the solvent.

In one embodiment, the concentrate container has an angled or V-shaped interior surface and is adapted such that it is positionable and operable by having the angle of the interior surface angled or V-shaped at the bottom. An example of this embodiment is the container 17 shown in Figure 1b in a perspective view from the bottom. The concentrate container 17 has a so-called sloped design. The medical fluid outlet 16 of the concentrate container 17, as compared to the concentrate container 10, is located in the wall 13 at the bottom. Therefore, an edge 19 of the concentrate container 17, which is formed by the bottom wall 13 and the side wall 11 that includes the solvent inlet 18, is located between the solvent inlet 18 and the solvent outlet 16. medical fluid. As a result, the edge 19 between the solvent inlet 18 and the medical fluid outlet 16 is preferably filled with solvent, if the concentrate container 17 is held in a correspondingly inclined manner such that the edge 11 is placed in the position lower. In this arrangement of the concentrate container, the solvent and concentrate loaded into the container 17 accumulate on the angled portion of the inner surface, that is, in the present example in the V-shape of the edge 19 between the inlet 18 of solvent and the medical fluid outlet 16, thus promoting dissolution of the concentrate. Since, in some embodiments, the concentrate container 17 is substantially rigid, the sloped design results in high mechanical strength, since a rigid edge can be placed on top. Furthermore, the inclined design concentrate container 17 can be easily and precisely arranged on a correspondingly angled or V-shaped support. Furthermore, a plurality of concentrate containers 17 can be stacked one on top of the other.

According to a further embodiment, a first concentrate compartment and a second concentrate compartment of the concentrate compartments are separated from each other by permanent barrier means, and each of the first and second concentrate compartments has a diluent inlet and a medical fluid outlet.

Fig. 2a schematically shows as an example of the above embodiment, furthermore, a concentrate container 20. In this, compartments 22 and 24 are separated by a permanent barrier means, which in the present example is a wall 25 completely separating compartments 22 and 24. In addition, compartments 22 and 24 each include a solvent inlet 18 and an outlet 16 for medical fluid.

In another embodiment, a first concentrate compartment and a second concentrate compartment of the concentrate compartments are separated from each other by a removable barrier means, for example a semi-permanent barrier, the first concentrate compartment has a diluent inlet. and the second concentrate compartment has a medical fluid outlet. This embodiment is based on the concentrate container 20 of FIG. 2a, wherein, however, the wall 25 is replaced by a removable barrier means (not shown), for example, a plate slide that can be manually or automatically actuated from outside the concentrate container. Another example for a removable barrier means is a piston valve (not shown) that can be opened by diluent or solvent due to fluid pressure and / or due to flow of diluent or solvent. Alternatively, the piston valve can be actuated from outside the concentrate container.

According to a further embodiment, a first concentrate compartment and a second concentrate compartment of the concentrate compartments are separated from each other by means of a permanent barrier, and each of the first and second concentrate compartments has a diluent inlet. and the first concentrate compartment has a medical fluid outlet; and a third concentrate compartment of the concentrate compartments is separated from the second concentrate compartment by removable barrier means and has a medical fluid outlet.

Figure 2b schematically illustrates as an example of a concentrate container 30 that includes three compartments 32, 33 and 34 of concentrate. The compartments 33 and 34 are separated by a removable barrier means, which is in the present example a piston valve 35 that can be opened due to fluid flow and / or pressure of the diluent or solvent. Compartment 33 includes a solvent inlet 18 and compartment 34 includes a medical fluid outlet 16. Compartments 32 and 33 are separated by wall 25 as a complete and permanent barrier means. Compartment 32 further includes a solvent inlet 18 and a medical fluid outlet 16.

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In embodiments described herein, one or more of the medical fluid outlets 16 may each be fluidly connecting a long channel having at least one outlet, eg, a central outlet. An example of such an embodiment is illustrated in Figure 3 in a top view. In these, a concentrate container 300 is shown which is based on a concentrate container 30 of FIG. 2b. The concentrate container 300 further includes a channel 150 extending along the side wall 11 in which the medical fluid outlets 16 of the concentrate container are formed. Channel 150 has a central outlet 160 through which the two fractions of medical fluid from medical fluid outlet 16 of compartment 32 on one side and medical fluid outlet 16 of compartments 33 and 34 on the other side can pass and combine. Thus, connectivity to a medical fluid transfer line is simplified, as only one medical fluid transfer line is required and can be connected to the central outlet 160 of the concentrate container 300.

The material of the concentrate containers may, according to embodiments, include polyamide or polyethylene, eg, HDPE. The concentrate container can be formed by injection molding. The internal volume of the concentrate container compartments may be in a range to contain concentrates for the intended volume preparation of medical fluid. For the preparation of a 60 1 batch of dialysis fluid a concentrate container volume of 2 1 is sufficient in some examples. This depends on the type of diluents which can contain various solutes. These solutes then do not have to be provided by the concentrates in the concentrate container. In general a concentrated volume of 0.5 to 3 1 may be appropriate for a wide range of applications. The concentrate container according to embodiments may be formed of a material including polypropylene (PP), polyethylene terephthalate (PET), polyurethane (PU), polysulfone (PSU), polyvinyl chloride (PVC), polyethylene (PE), polystyrene (PS), polyalphaolefins, copolymers of propylene, ethylene, butylene, octane, and polymer blends of the aforementioned polymers.

In addition, the embodiment concentrate container may have at least one fluid transmission means. The fluid transmission medium is sealed outside the compartments. An example of a container 40 having a fluid transmission means shown in Figure 4. The concentrate container 40 includes a tube 49 as a fluid transmission medium that passes through the compartment 12 and which allows the passage of fluids through the compartment 12 without mixing with concentrates, suspensions or fluids contained in the compartment 12. The lumen interior of the fluid transmission means can be in a range of 3 to 20 mm, the wall thickness of the fluid transmission means can be 1 to 2.5 mm.

In a further embodiment, the first concentrate compartment includes at least one restriction means or at least one restriction means that subdivides the first concentrate compartment into sub-compartments. For example, as shown in Figure 5, the concentrate compartment 12 includes a partial wall 52 that allows fluid or concentrate to pass between two sub-compartments 53 and 54 separated by the partial wall 52. Restrictors promote dilution and / or dissolution of concentrates during diluent filling into the first concentrate compartment, as they increase water velocity and turbulence. At least one of the restrictors can be or include a nozzle or frit, which can cause turbulence.

According to exemplary embodiments, the concentrate container includes at least one filter medium provided in at least one medical fluid outlet and / or in the at least one diluent inlet. For example, in the concentrate container shown in Figure 5, filter media 55 is provided at the solvent inlet 18. Additional filter media (not shown in Figure 5) can be installed in the medical fluid outlet 16 of compartment 12. In this way, the leakage of undissolved particles out of the concentrate container can be prevented. Furthermore, filtering of the dialysate or medical fluid can be achieved. The filter media can be formed from a material including polyethylene. In one example, the filter medium 55 is a Porex microporous filter having a mean porosity of 180 to 300 µm and a thickness of 2.9 mm. For example, the filter can be a sterile filter with a mean pore size of 0.22 pm to 5mm.

The concentrate container of embodiments may include a lid or a sealable lid, adapted to close at least one of the concentrate compartments. An example of such an embodiment is shown in Figure 6, wherein the concentrate container 60 includes a lid 61 for closing all compartments. In this way, contamination of concentrates contained in closed concentrate compartments can be prevented. In addition, the concentrate container 60 can be shaken or tilted without loss of concentrates and / or the diluent it contains. The lid 61 may be a 6 mm thick poly (methyl methacrylate) (PMMA) window hinged to a side wall 11 of the concentrate container. According to another example, the cap can be formed from a polyamide / polyethylene (PA / PE) sheet welded onto the concentrate container. Also, a PA / PE sheet can be applied as a cap. In one embodiment the PA / PE sheet is formed from a two-layer or multi-layer film, whereby a layer is formed from the PE polymers for welding purposes. The other layer is formed from the PA polymers for the establishment of a high tear resistance and a suitable gas barrier of the multilayer film. The thickness of the multilayers can be about 200 µm and the dimension of the lid can be about 40 x 10 cm depending on the dimensions of the concentrate container.

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According to one embodiment, a system for preparing a medical fluid, preferably for preparing a dialysis solution, is provided, the system including a concentrate container according to embodiments described herein, a fluid container fluidly connecting a medical fluid withdrawal line, at least one fluid transfer line fluidly connecting the at least one medical fluid outlet of the concentrate container and the fluid container.

The system for preparing a medical fluid, according to the embodiments, allows a physical separation between the dry concentrates, a dissolution of the concentrates in different stages with high efficiency, and an efficient disposal of residues. Furthermore, the parts of the system can be formed by simple production processes, and the system can be easily assembled and disassembled. On the other hand, using the system of embodiments, a medical fluid can be prepared in situ in a container, in which the concentrates have been stored and while the container has been provided in the system.

FIG. 7 illustrates a system 100 as an example of a medical fluid preparation system in accordance with embodiments. The system 100 includes a concentrate container 20 of Figure 2a, in which the wall 25 is replaced by a removable barrier means 35, for example, a plate slide that can be opened and closed. In addition, the system 100 has a fluid container 110 that is fluidly connected to the concentrate container 20 through a fluid transfer line 114. In the present example, the fluid transfer line 114 is a connecting tube. outlet 16 of medical fluid from concentrate container 20 and fluid container 110. The latter is shown in figure 7 as a non-transparent bag. The fluid container 110 has an opening, which in the present example is the medical fluid drain line 111 and is fluidly connected to a medical fluid extraction line 112 to withdraw a medical fluid collected in the fluid container 110. . In this example, the internal volume of the concentrate container compartments may be in a range to contain concentrates for the intended volume preparation of the medical fluid. For the preparation of a 60 l batch of dialysate a concentrate container volume of 2 l is in some examples sufficient. This depends on the type of diluents that various solutes can contain. These solutes then do not have to be provided by the concentrates in the concentrate container. In general a concentrated volume of 0.5 to 3 l can be appropriate for a wide range of applications. The third container 110 may have an internal dimension of approximately 70L.

To form a medical fluid, the concentrate container 20 including a removable barrier means 35 is provided with two different concentrates, for example dry concentrates, contained separately in concentrate compartments 12 and 14. A solvent is introduced through from opening 18 into compartment 14, dissolving and / or suspending the concentrate provided in compartment 14. Thereafter, the solvent including dissolved and / or suspended concentrate from compartment 14 passes into compartment 12 after release from the barrier means 35, thereby dissolving and / or suspending the concentrate contained therein. Thereafter, medical fluids made up of the solvent and the concentrates dissolved or suspended therein leave the concentrate compartment 12 through the opening 16 and the fluid transfer line 114 and are collected in the fluid container 110. The medical fluid can then be withdrawn from the fluid container 110, for example, by a pump installed in the medical fluid extraction line 112.

Examples of diluents or solvents used in embodiments described herein are diluents for the formation of medical fluids, such as reverse osmosis (RO) process water, dilute solutions containing solutes or parts of solutes necessary for the final concentrated medical solution. The amounts of diluents used in the examples correspond to the final volumes of the medical solutions that were prepared. The preparation of the volumes of diluents can be adapted depending on the volume of the solution to be prepared. For example, solution volumes can be 2-120 L, 5 to 80 L, 30 to 80 L is preferred, more preferably 50 to 70 L.

In the example of Figure 7, the solvent inlet 18 may be connected to a solvent feed line 118 as a diluent feed line, as shown in Figure 8. Therefore, according to the embodiments, at least one diluent inlet of the concentrate container is fluidly connected to a diluent feed line.

Furthermore, according to embodiments, at least one of the concentrate containers, the fluid container and the fluid container system is tiltable and / or removable installable or tiltable and / or removable installed in the system. By tilting the concentrate container, the dissolution of the concentrates in the solvent can be promoted. Furthermore, because the concentrate container and / or the fluid container (s) are removable, a simple replacement of the containers is feasible, in order to provide fresh concentrates contained in the concentrate container, and / or in order to avoid contamination of the system by providing fresh containers.

In accordance with other exemplary embodiments, the fluid container may include a medical fluid drain line 111, which may include a tube (not shown in Figure 7) and an opening in the top of the fluid container, the tube extending from the opening to the bottom of the fluid container. In this way, the withdrawal of the medical fluid from the fluid container is easier.

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In another embodiment, the system may include another fluid container connected to a used medical fluid collection line, the fluid container insertable into the other fluid container. An example of this embodiment is illustrated in FIG. 8 as part of one embodiment of a system 101 having the concentrate container 10 of FIG. 1a fluidly connected via fluid transfer line 114 to the container 110 of fluid shown in Figure 7. The concentrate container 10 further has the solvent charge line 118 connected to the solvent inlet 18 as an optional feature. In addition, another fluid container 120 is provided that encompasses the fluid container 110. In FIG. 8, the fluid container 120 is transparent, but is not limited thereto in accordance with the embodiments described herein. The fluid container 120 is fluidly connected to a tube 122 which is a collection line for consumed medical fluid, which is, for example, connected to a dialysis machine (not shown). As an optional feature, fluid container 120 includes tube 121 fluidly connected to tube 122, for orientation and / or removal of consumed medical fluid in / out of fluid container 122.

The concentrate container of the medical fluid preparation system, according to embodiments, may have at least one fluid transmission means, a fluid transmission means being connectable or weldable to the medical fluid drain line. and / or other fluid transmission means that can be connected or welded to the used medical fluid collection line. An example of this embodiment is shown in Figure 9a, where a concentrate container 70 has two fluid transmission means 49, one of which is fluidly connected to medical fluid drain line 111 of the container 110 of the concentrate. fluid and one of which is fluidly connected to tube 121 provided in fluid container 120. A port of the concentrate container is shown in Figure 9a, the port is positioned between the two fluid transmission means 49, it may be a solvent inlet.

In Figs. 9a, 9b, 9c, 9d, 10a and 10b, fluid containers 110 and 120 are illustrated as transparent bags, but according to embodiments described herein the fluid containers are not limited thereto.

Tubing materials and dimensions used for fluid transfer line 114, consumed medical fluid collection line 122, medical fluid drain line 112, solvent charge line 118 may include PP, styrene block copolymers to starting from styrene butadiene, ethylene, isoprene (SEBS; SIS; SEPS), PVC, silicone, PE, polyalphaolefins.

According to embodiments, the concentrate container can be placed on top or bottom of at least one fluid container and the other fluid container. An example of the concentrate container located on top of at least one of the fluid containers is shown in Figures 10a and 10b. If the concentrate container is located below the fluid container (s), no tubes are needed inside the fluid container for drainage or agitation.

In other exemplary embodiments, the medical fluid preparation system includes a transport means adapted to support and / or to include at least one of the concentrate containers, the fluid container, and the other fluid container, as illustrated. schematically in Fig. 11. Hence, according to one example, a transportation means such as a cart 200 is schematically shown, which includes the fluid container system arranged in the concentrate container as shown in Figs. 10a and 10b. For example, the cart 200 can be a transparent container that has lower wheels. For installation, the concentrate container 70 may include brackets 201 for mounting on top of the cart 200. In this way, the medical fluid preparation system can be used regardless of its location at any time. Cart 200 may be adapted to transport large amounts of solution, such as about 50-100 liters, eg, about 72 liters.

In the exemplary embodiments, the system for preparing a medical fluid can be adapted to be a mobile and / or modular system. In addition, the concentrate container, the fluid container, the other fluid container, and / or the transport means may be modular components of the system. Furthermore, the concentrate container can be substantially rigid or substantially inflexible. In some embodiments, the fluid container and the other fluid container are substantially flexible, eg, flexible bags.

The fluid container and / or the other fluid container of the embodiments described herein may have an internal capacity of about 60 to 70 liters, in order to accommodate large volumes of fluids. The other fluid container can in some examples also be used to house the ultrafiltrate of a patient.

The fluid container and the other fluid container of the embodiments described herein may each be formed of PET, PA, PE, PP, PVC, preferably as multilayer films. For example, the fluid container and the other fluid container can be formed from a multilayer film including PA or PET and PE. Thus, excellent weldability of the inner layers of container films and superior compatibility with medical solutions can be achieved.

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In some embodiments, at least two different components of a concentrate, for example, components of a dry concentrate, are provided in different concentrate compartments of the concentrate container. For example, each concentrate component is loaded into its own concentrate compartment. In this way, a mixture of different concentrates, eg different dry concentrates, contained in different concentrate compartments can be avoided during supply and storage of the concentrates in the compartments. Furthermore, degradation and caking of dialysate components can be prevented or at least reduced.

For example, one of the concentrate compartments, eg, the second or third compartment, includes the glucose, preferably separately from other components of the concentrate. In addition, at least two other different concentrate components added in the concentrate container include at least one item selected from sodium bicarbonate, sodium chloride, magnesium chloride, potassium chloride, calcium chloride, and citric acid. For example, a first component of a concentrate includes sodium bicarbonate and sodium chloride, a second component of the concentrate includes sodium chloride, magnesium chloride x 6 H2O, potassium chloride, calcium chloride x 6 H2O, and anhydrous citric acid. , and a third component of the concentrate includes glucose x H2O.

In an example of a concentrate container, the first compartment contains granules made up of 37% NaCl and 63% sodium bicarbonate, for example 515 g, the second compartment contains glucose monohydrate, for example 66 g, and the third compartment contains minor ions and citric acid, for example, 75 g. Minor ions are, for example, NaCl, KCl, MgCl2, CaCl2. In a variation of this example, the contents of the second and third compartments can be interchanged, so that the second compartment contains minor ions and citric acid, and the third compartment contains glucose monohydrate. The minor ions are for example the ions of lower concentration present in the dialysis fluid compared to the bicarbonate ions or sodium ions.

According to one example, a first component of a dry concentrate includes 187.5 g of sodium bicarbonate and 327.5 g of sodium chloride; a second component of the dry concentrate includes 35 g of sodium chloride, 6.1 g of magnesium chloride x 6 H2O, 8.95 g of potassium chloride, 13.2 g of calcium chloride x 6 H2O, and 11.5 g of anhydrous citric acid; and a third component of the dry concentrate includes 66 g of glucose x H2O. The first to third components can be provided separately in different compartments of the embodiment concentrate container. By adding a corresponding amount of RO water from the first to the third component and the combination of the resulting solutions, a dialysate that is useful for hemodialysis is obtained, which has the following component ratio: Na +: K +: Mg²+: Ca²+: Cl: HCO3 - = 140: 2: 0.5: 1.5: 108: 35.

According to embodiments, glucose can be provided separately in one of the compartments of a concentrate container for the formation of a dialysate. If glucose is given in a mixture with dry bicarbonate, it can be degraded, resulting in by-products that can generate unwanted effects when administered to patients. Caking of glucose mixed with other components of the dialysate usually causes imperfect dissolution of the components in RO water. With the use of embodiments described in this document, these unwanted effects can be prevented.

In a further embodiment, a fluid container system for preparing a medical fluid, preferably for preparing a dialysis solution, is provided, including a fluid container for collection of a disposed medical fluid, the fluid container having a medical fluid drain line, and another fluid container for collecting a consumed medical fluid, the fluid container can be inserted into the other fluid container. The medical fluid drain line may include an opening, port, and / or tube, each adapted for drainage of medical fluid from the fluid container.

An example of this embodiment has been described above with reference to the two fluid containers 110, 120 shown in Figure 8. Figure 9b illustrates another example of this embodiment, wherein the fluid container 110 and the fluid container 120 are flexible transparent plastic bags. These bags can also be disposable to facilitate the maintenance of a contamination-free system. As shown in Figure 9b, bags 110 and 120 may each have gussets 71 on each side of the bag. Bag 120 has a larger internal volume than bag 110, such that the latter can be inserted into bag 120. Figure 9a illustrates the fluid container system illustrated in Figure 9b mounted on concentrate container 70.

Figures 10a and 10b show another example of an embodiments fluid container system, in which the two fluid containers 110 and 120 each include a bottom portion that includes two outwardly bendable pleats. This example is useful if the fluid container and the other fluid container are flexible bags that have to be placed on a rigid support, such as a means of transport, for example, because of a high weight of the contents that filled the containers. fluid containers. Thus, the volumes of fluid to be stored inside the bags can be reduced, as the spatial volume of the bags can also be reduced due to the flexible folding and its flexibility. In addition, the bags can be opened symmetrically and evenly during filling. In addition, a constant height of the bags during filling and use can be maintained.

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In this example the fluid container system can also be mounted on a concentrate container 70. F igure 10a shows the system fluid container of this example having the folds bent upwards, while Figure 10b illustrates the system fluid container having bent folds sideways.

Therefore, in the examples of the fluid container system at least one element chosen between the fluid container and the other fluid container may be a flexible container, a disposable container, a bag, for example a stand-up bag, a bag that has a gusset on each side and / or a bag that has a bottom that includes two outward pleats that can be folded.

In accordance with other embodiments, the medical fluid drain line and / or the other fluid container may each include a tube that extends into or to the bottom of the respective fluid container. In some examples, the tube may include at its free end inside the respective container a nozzle as a limiter, for example for the production of turbulence. Tube material may include PP, styrene butadiene block copolymers, ethylene, isoprene (SEBS; SIS; SEPS), PVC, silicone, PE, polyalphaolefins. In this way, removal of fluids from the fluid containers is facilitated and the additional tubes can provide agitation of the fluid within the fluid containers. The tube of the medical fluid drain line 111 and the tube of the other fluid container 120 are shown, for example, in FIG. 9a.

In embodiments, the fluid container includes at least a first connecting line means for at least one fluid transfer line and a second connecting line means connectable to, connected to, or included in the fluid drain line. doctor.

In other embodiments of the fluid container system described herein, the inner fluid container includes a first connection line means 1140 for the fluid transfer line 114 and a second connection line means 1111 included in the line 111 medical fluid drain outlet, and / or the outer fluid container includes in the tube a third connecting line means 1221 for the consumed medical fluid collection line, as shown in FIG. 9b. This allows for easy interconnection of the fluid container and the other fluid container with the concentrate container through the fluid transfer line 114, with the medical fluid extraction line 112 and / or with the collection line 122 of the fluid. consumed medical fluid. The connecting line media material may include PP, styrene block copolymers from styrene butadiene, ethylene, isoprene (SEBS; SIS; SEPS), PVC, silicone, PE, polyalphaolefins.

In embodiments, the concentrate container may have a channel that is fluidly connected to one or more of the medical fluid outlets and that has at least one outlet.

According to another embodiment, the inner fluid container 110 includes two first connecting line means 1140a and 1140b for two transfer fluid lines 114a and 114b and a second connecting line means 1111 included in or connected to line 111 medical fluid drain valve, as shown in Figure 9c. Connecting line means 1140a may be connected to a tube 115 extending to the bottom of the inner fluid container, as shown in Figure 9c. In the present embodiment, the inner fluid container 110 is connected to a concentrate container 302, which differs from the concentrate container 300 shown in Figure 3 in that instead of the central outlet 160, two outlets 160a and 160b are provided inside. channel 150. Outlet 160a is connected through fluid transfer line 114a and connecting line means 1140a for internal fluid container 110. The outlet 160b is connected through the fluid transfer line 114b and to the connection line means 1140b to the internal fluid container. In addition, the concentrate container 302 has a tube 49 as a fluid transmission means that passes through the compartment 32 and which allows the passage of fluids through the compartment 32 without mixing with concentrates, suspensions or fluids contained in the compartment 32. In the present embodiment, the medical fluid drainage line 111 is fluidly connected through a second connecting line means 1111 and the medical fluid withdrawal line 112 to tube 49 for passage of drained medical fluid through of a concentrate container 302. The outer fluid container 120 may include in its tube (not shown) a third connecting line means for a collection line of consumed medical fluid (not shown in FIG. 9c). This embodiment allows for easy interconnection of the fluid container with the concentrate container through two fluid transfer lines and one medical fluid withdrawal line.

In some embodiments, the concentrate container includes a first channel that is fluidly connected to one of the medical fluid outlets and has one outlet, and a second channel that is fluidly connected to another of the medical fluid outlets. and having another outlet, wherein the first and second channels are fluidly separated by separation means.

Figure 9d illustrates a further embodiment of a medical fluid preparation system, including a concentrate container 303 in accordance with one embodiment. The system of Figure 9d differs from the system of Figure 9c in that the inner fluid container 110 is connected to a concentrate container 303. The concentrate container 303 differs from the concentrate container 302 of FIG. 9c in that that channel 150 has a

ES 2 659 983 T3 means 313 of separation between the outlets 160a and 160b. Thus, channel 150 is subdivided into two separate channels 150a and 150b. The partition means 313 may be a partition wall or a partition strip, which completely separates the fluids passing through openings 16 in the outlets 160a and 160b from each other. This means that fluid from concentrate compartment 34 and flowing through outlet 160b does not mix with fluid from concentrate compartment 32 and flowing through outlet 160a. In this way, unwanted gas formation caused by the intermixing of the two fluids is avoided. Such gas formation can hinder or prevent the discharge of the concentrates and / or fluids containing the concentrates from channel 150.

For example, using a concentrate container 303 of the present embodiment, the evolution of CO2 gas due to contact or mixing of a fluid, which contains bicarbonate and originates from the concentrate compartment 32, and a fluid, which contains an acid and originates from the concentrate of compartments 33 and 34 is avoided and / or prevented inside channel 150 and inside fluid transfer lines 114a and 114b, due to separation means 313.

In addition, using the embodiment of the system of FIG. 9d, bicarbonate-containing fluid originating from compartment 32 can be directed through fluid transfer line 114a and tube 115 to the bottom of container 110. internal fluid. Fluid containing acid originating from compartments 33 and 34 may be directed through fluid transfer line 114b and first connecting line means 1140b into inner fluid container 110 from above. Thus, the evolution of CO2 gas caused by the contact or mixing of the two fluids occurs in the fluid container 110 110. On the other hand, guiding the bicarbonate-containing fluid to the bottom of the inner fluid container 110 and adding the acid-containing fluid from the above results in rapid intermixing of the two fluids. This makes it possible to avoid or prevent local variations in the concentrations of the dissolved concentrates. The CO2 gas developed by mixing the two fluids can be discharged through the medical fluid removal line 112 or through another port of the internal fluid container 110, in order to depressurize.

A further embodiment refers to a kit of parts for the preparation of a medical fluid, which includes at least two elements selected from the concentrate container according to any example or embodiment described in this document, a fluid container, the system of fluid container according to any example or embodiment described herein, and a transport means adapted to support and / or to include at least one of the concentrate container, the fluid container, and the fluid container system. The means of transportation for the parts kit may be cart 200 shown in Figure 11.

The concentrate container, kit of parts and / or any system according to embodiments described herein can be used in dialysis, acute dialysis, hemodialysis, hemodiafiltration, peritoneal dialysis, or preparation of a dialysis solution.

A still further example is directed to a method of preparing a medical fluid, preferably of preparing a medical fluid or a dialysis solution in a system for preparing a medical fluid according to any embodiment described herein, the method includes providing a concentrate container that includes at least one concentrate compartment, wherein a first compartment of the concentrate compartments contains a first concentrate component; load a diluent in the first compartment; rinse the first compartment with the diluent and dilute the concentrated component; and transferring the diluted first concentrate component into a fluid container. In this way, contamination or degradation of the concentrate component contained in the first concentrate compartment of the unwanted concentrate container can be avoided.

In the method, the concentrate container may further include a second concentrate component in a second compartment of the concentrate compartments; The method further includes charging the diluent in the second compartment; rinsing the second compartment with the diluent and diluting the second concentrate component; and transferring the second dilute concentrate component into the fluid container. This means that the different concentrate components contained in two different compartments of the concentrate container can be diluted, dissolved or suspended individually and without mixing, and / or one after the other.

Furthermore, in an example of the method, each of the first and second compartments can be separately loaded with the diluent and rinsed. In other embodiments, the loading and rinsing of the second compartment can be accomplished by passing the diluent from the first compartment into the second compartment. This can, for example, be achieved by passing the diluent through an opening between the first and second compartments or by releasing a removable barrier means between the first and second compartments.

In some embodiments, the concentrate container further includes a third compartment containing a third concentrate component, each of the first and second compartments was separately charged with the diluent and washed, and the loading and rinsing of the third compartment and the dilution of the third component of concentrate was carried out by passing the diluent from the second compartment into the third compartment, 11

ES 2 659 983 T3 for example by opening a removable barrier means between the second and third compartments. For example, the concentrate container further includes a third compartment containing a third concentrate component; each of the first and second compartments was separately charged with the diluent and rinsed; and the method further includes, prior to transferring the component of the second diluted concentrate into the fluid container, loading the diluent into the third compartment by opening a removable barrier means between the second and third compartments and passing the diluent from the second compartment to the third compartment, and rinse the third compartment from concentrate and dilute the third concentrate component. Thereafter, the second and third diluted concentrate components are transferred to the fluid container.

For example, the first and second concentrate compartments are separated by means of a permanent barrier and the second and third concentrate compartments are separated by means of a removable barrier. The latter can be a piston valve that can be opened due to flow and / or fluid pressure of the diluent. In one example, in the first compartment containing sodium bicarbonate as a concentrate component, RO water is introduced in a first stage and the sodium bicarbonate is dissolved separately from the other concentrate components contained in the other compartments. Then, in a second step RO water is charged into the second compartment containing anhydrous citric acid as a component of the concentrate. RO water dissolves citric acid and passes from the second concentrate compartment to the third concentrate compartment, which contains calcium chloride as a component of the concentrate, by opening the piston valve due to fluid flow and / or pressure . In this way, the calcium chloride dissolves. By using this sequence of steps, unwanted effects resulting from degassing and / or precipitation of one or more of the concentrate components due to intermixing of the concentrate components and due to the dilution process can be avoided.

The method allows the different concentrate components to be provided and / or stored in separate concentrate compartments prior to preparing the medical fluid. Furthermore, the preparation of the medical fluid can be carried out in separate compartments of the concentrate container by individually diluting, the solution and / or suspension of the different components of the concentrate of the medical fluid and subsequently combining them. In this way, degradation and caking of the concentrate components due to mixing of the components before dilution by the diluent can be avoided. Furthermore, by performing an appropriate dilution sequence for the different components of the concentrate, degassing and precipitation of concentrate components during dilution can be reduced or avoided. Consequently, a complete dissolution of the concentrate components or concentrates, respectively, contained in the concentrate container can be achieved, in order to form the medical fluid.

According to examples of the procedure for preparing a medical fluid, during the loading of the diluent a first diluent is introduced into the first compartment and a second diluent is introduced into the second compartment, the first and second diluents are different from each other . Thus, different solvents can be used for different concentrates or concentrate components, depending on the solubility of the same.

In the method, the feeding of the diluents can be done through at least one diluent inlet and the transfer of the diluted concentrated components can be done through at least one medical fluid outlet, the at least one diluent inlet. and the at least one medical fluid outlet are separated from each other.