Medical insert container for an extracorporeal blood treatment machine, extracorporeal blood treatment machine and method for producing a medical insert container

Abstract

The disclosure relates to a medical insert container (2; 102) for insertion into and for fluidic connection to an insert container receptacle (4) of an extracorporeal blood treatment machine (1), wherein the insert container (2; 102) is provided and designed for receiving and bringing into solution a medical dry substance (14) and for providing a medical solution (36), and comprises: an inlet (10; 110) which is provided and designed for fluidic connection to a solvent inlet (6) of the insert container receptacle (4) and supplying a solvent (34); a container chamber (18; 118) which is provided and designed to receive the dry substance (14) and to bring it into contact with the supplied solvent (34); and an outlet (12; 112) which is provided and designed for fluidic connection to a solution outlet (8) of the insert container receptacle (4) and for providing the medical solution (36), wherein a main body (16; 116) is formed by the container chamber (18; 118), the inlet (10; 110) and the outlet (12; 112), which main body is in one piece. The disclosure further relates to an extracorporeal blood treatment machine and to a method for producing a medical insert container.

Description

[0001] BV1185P-WO-0008 2024P00044WG

[0002] 1 / 26

[0003] Medical insert container for an extracorporeal blood treatment machine, extracorporeal blood treatment machine and method for manufacturing a medical insert container

[0004] Description

[0005] Technical field

[0006] The present disclosure relates to a medical insert container for the preparation and provision of a medical, in particular alkalizing, solution from, in particular alkalizing, dry substance for an extracorporeal blood treatment machine. Furthermore, the present disclosure relates to an extracorporeal blood treatment machine, in particular a dialysis machine, for extracorporeal blood treatment, such as hemodialysis, hemofiltration, hemodiafiltration and / or ultrafiltration, as well as a method for manufacturing a medical insert container.

[0007] A blood treatment machine of this type has a dialyzer with a semipermeable membrane for the exchange of substances between a patient's blood, circulating in an extracorporeal blood circuit, and a dialysis fluid from a separate dialysis fluid circuit. The extracorporeal blood circuit passes through the dialyzer via a blood inlet and a blood outlet. A mixing unit of the blood treatment machine mixes ultrapure water with an alkalizing dry substance, in particular a bicarbonate dry substance, specifically to prevent potential acidosis. An acidic concentrate is also added in the mixing unit. The resulting fresh dialysis fluid is then supplied to the dialysis fluid circuit.

[0008] Technical background

[0009] In extracorporeal blood treatment, for example blood purification in the form of hemodialysis, hemofiltration or hemodiafiltration, blood is taken from a dialysis patient via an arterial vascular access and via a BV1185P-WO-0008 2024P00044WO

[0010] 2 / 26 extracorporeal blood circulation is fed to a dialyzer for blood treatment. Freshly prepared dialyzer fluid is also supplied to the dialyzer as needed via a dialyzer fluid circuit. To produce the fresh dialyzer fluid, ultrapure water is provided by a water purification system, degassed, and then mixed in a mixing unit with an alkalizing dry substance and an acidic concentrate. Bicarbonate, for example, is used as the alkalizing dry substance. The bicarbonate is provided in a feed container with a size and connection topology tailored to the blood treatment machine. The blood treatment machine is equipped with a feed container receptacle of a predetermined size and connection topology.

[0011] Conventional insert containers, such as the bicarbonate cartridge developed by the applicant and known as Sol-Cart® B, are multi-part, often made of polypropylene, and manufactured using injection molding technology followed by assembly. A new insert container design requires a correspondingly new injection mold, or the existing mold must be modified for any design changes, which is a costly and time-consuming process. Furthermore, the manufacturing and filling of the insert container is also complex.

[0012] Summary of the present disclosure

[0013] In contrast, the purpose of the present disclosure is to avoid or at least mitigate the disadvantages of the prior art and to provide a medical insert container for an extracorporeal blood treatment machine that can be provided with less effort. Furthermore, the purpose is to provide a less complex method for manufacturing an insert container.

[0014] The object of the present disclosure is achieved, with regard to the insertion container, by the features of claim 1, with regard to the extracorporeal blood treatment machine by the features of claim 13, and with regard to the method by the features of claim 14. BV1185P-WO-0008 2024P00044WO

[0015] 3 / 26

[0016] Further training opportunities are claimed in the dependent entitlements and / or described below.

[0017] A key concept of the present disclosure is the creation of a medical insert container in which a medical solution for an extracorporeal blood treatment machine can be prepared and supplied ready for use. According to the disclosure, the insert container has a one-piece, unjointed base body with an inlet for supplying a solvent, a reservoir for receiving and dissolving a medical dry substance contained therein, and an outlet for supplying the medical solution thus prepared. Medical dry substances include, in particular, an alkalizing dry substance, such as a bicarbonate, or a dry substance containing NaCl or glucose, or a nutrient or drinking solution.

[0018] In general terms, the input container is designed and configured to receive a medically relevant, soluble solid, to supply a solvent at the inlet that flows through the solid, thereby creating a saturated / defined solution in the container space and making this available at the outlet in order to subsequently produce an end product in a desired / defined composition, in particular through the controlled and defined addition of another component in the sense of a dosing process.

[0019] Another use of the insert container is to hold an absorber or carrier material, particularly for binding or removing toxic substances from blood or dialysis fluid. For example, dialysate can be recycled and, after purification, reintroduced into the therapy cycle as fresh dialysis fluid. Other uses include holding solid carrier substances or granules, for example, for water desalination, or holding and dosing solid concentrates, such as cleaning agents.

[0020] A medical insert container is, according to the disclosure, for insertion into and fluidic connection with an insert container receptacle of a BV1185P-WO-0008 2024P00044WO

[0021] 4 / 26 extracorporeal blood treatment machine provided and designed. The extracorporeal blood treatment machine is provided and designed for blood treatment, preferably intermittent or outpatient. The insert container is provided and designed for receiving and dissolving a medical, in particular alkalizing, dry substance, as well as for providing a medical, in particular alkalizing, solution, and has:

[0022] - an inlet which is designed and configured for fluidic connection with a solvent inlet of the insert container and supply of a solvent,

[0023] - a container space designed and configured to receive the dry substance and bring it into contact with the supplied solvent, and

[0024] - a process that is designed and configured for fluidic connection with a solution flow of the insert container intake and for the provision of the medical solution.

[0025] According to the disclosure, the container space, the inlet and the outlet form a basic body of the medical use container, which is one-piece, i.e., it is manufactured without joining.

[0026] This creates a medical deployment container that can be provided with less effort, as it has a one-piece base body manufactured without joining.

[0027] The inlet is located at the top and the outlet at the bottom of the container, as intended.

[0028] Preferably, the inlet and outlet are arranged diametrically opposite to the container space. In particular, they extend diametrically outward from the container space.

[0029] According to further training, the base body is made of or contains polyethylene terephthalate (PET). Compared to polypropylene (PP), PET is stronger and more break-resistant, which, compared to a PP base body, allows for a reduction in material usage and thus in material costs and the weight of the insert container. This reduction can be approximately 50%. BV1185P-WO-0008 2024P00044WG

[0030] 5 / 26. For example, the empty weight of a bicarbonate-containing insert container can be reduced from 60g to approximately 30g.

[0031] According to a further development, the wall thickness of the container space is less than 2 mm, preferably less than 1 mm.

[0032] According to further training, the basic body is stretch blown or injection stretch blown. This allows for particularly thin wall thicknesses of less than 2 mm with minimal manufacturing effort, which reduces material usage – and thus material costs and weight.

[0033] According to further training, an elastic section of the container space borders the inlet or the outlet, or both.

[0034] The elasticity of the elastic container section is preferably based on its shape and / or wall thickness. For example, the elastic container section borders the inlet or outlet in a spherically convex or flat manner, such that an axial load on the inlet or outlet causes the elastic container section—and thus the inlet or outlet—to compress elastically in the axial direction. This elasticity allows the insert container to be placed into the insert container receptacle with a preload. This preload and the elastic compression, as well as any elastic rebound, facilitate pre-positioning, positioning, securing, and / or sealing of the inlet and / or outlet in or on the insert container receptacle.

[0035] According to further training, the elastic section of the container has a reduced wall thickness compared to the rest of the container space, which contributes to its elasticity.

[0036] According to a further development, the inlet or outlet, preferably both, has a coupling element or coupling section, preferably an external thread, which is stretch blow-molded or injection stretch blow-molded together with the inlet or outlet, i.e., in the same manufacturing step, and which is provided and designed for coupling, preferably screwing, with a sealing cap. BV1185P-WO-0008 2024P00044WÖ

[0037] 6 / 26

[0038] According to a further development, the base body, preferably the container space, has a filling scale which is stretch blown or injection stretch blown together with the base body, i.e. in the same manufacturing step, preferably with the container space.

[0039] Preferably, the container space, or at least the filling scale, is designed to be transparent, so that a simple visual assessment of the fill level and phase formation or phase arrangement in the container space is possible.

[0040] Preferably, the filling scale is structured stretch blown or injection stretch blown, so that a simple visual quantification of the fill level in the container space, as well as of phase boundaries or phase fractions in the container space, is possible.

[0041] According to further training, the inlet and outlet of the main body have different diameters.

[0042] According to further training, one of the inlet and outlet is stretch-blown or injection-blown with an opening and is thus designed and intended for filling the container space with the dry substance.

[0043] According to a further development, the inlet and outlet have different diameters. According to a preferred further development, the larger diameter is stretch-blown or injection-blown as an opening and is thus designed and configured for filling the container space with the dry substance.

[0044] According to a further development, one of the inlet and outlet, preferably the one with the smaller diameter, is closed, i.e., stretch blown or injection stretch blown without an opening. Preferably, the end-face wall thickness of the closed inlet or outlet is small, so that when the insert container is placed into the insert container receptacle, an opening is created, in particular by perforation or punching, through a dome of the insert container receptacle BV1185P-WO-0008 2024P00044WQ

[0045] 7 / 26 can be trained. Alternatively, the opening can also be created after stretch blow molding / injection stretch blow molding, for example by drilling.

[0046] According to a preferred further development, the medical dry substance is contained in the container space of the base body of the medical application container.

[0047] According to a preferred embodiment, the container space is designed in a cuboid shape. To optimize injection stretch blow molding or stretch blow molding production, the edges are preferably rounded. In other words, the insert container has a cuboid shape with rounded edges. This optimizes the packaging format of the insert container(s), allowing a particularly large number of the disclosed insert containers to fit into a predetermined carton and be arranged securely. This results in less empty space compared to round or funnel-shaped insert containers, especially those made of PP. Therefore, the insert containers designed according to the disclosure can be packed more densely, optimizing transport and storage costs.

[0048] According to a preferred embodiment, the inlet and / or outlet of a cap is configured with a connection or port for linking to the solvent inlet and / or solution outlet of the insert container. The cap is preferably screwed directly onto the inlet and / or outlet. If a design change or modification is necessary, such as a change in the geometry of the port or a modification of the filter, only the caps need to be adjusted. These caps are preferably manufactured from polyethylene by injection molding. Alternatively, they are manufactured from polypropylene.Preferably, a releasable, hinged, or pivotable cover or cap is provided that covers the connector or port and exposes the connector or port when released, hinged, or pivoted. Advantageously, the cover cap is an injection-molded part, preferably a standard or off-the-shelf part. BV1185P-WO-0008 2024P00044WO.

[0049] 8 / 26

[0050] The design and / or specific features of the closure cap are preferably tailored to a specific application and use. For example, adapter pieces or adapter ports of the insert container for connection to a cartridge holder of the extracorporeal blood treatment machine, i.e., for mechanical and fluidic connection to the insert container receptacle of the extracorporeal blood treatment machine, in particular a dialysis machine, are designed so that they fit precisely into this receptacle, allowing the insert container to be connected to the extracorporeal blood treatment machine.

[0051] A cap can also serve as a tamper-evident seal. This ensures, for example, that the user can clearly identify a previously opened product (insert container).

[0052] One advantage of the closure caps being designed as separate components is, for example, that any adjustments, such as changes to the design and / or geometry of the connection ports or adapter ports, or changes to the filter, can be made separately without simultaneous adjustments to the insert container.

[0053] According to a preferred embodiment, the cap at the inlet or outlet, or both, is equipped with a tamper-evident seal. This tamper-evident seal provides security and control against unintentional or premature opening of the container, thereby ensuring and verifying the authenticity and quality of the contained dry substance.

[0054] According to a preferred embodiment, an opening of the inlet and / or the outlet is sealed.

[0055] According to a preferred embodiment, the inlet and / or outlet, in particular the cap, has a filter, especially a frit, to prevent the introduction of contaminated solvent and / or the discharge of contaminated solution and / or undissolved dry matter. BV1185P-WO-0008 2024P00044WG

[0056] 9 / 26

[0057] An extracorporeal blood treatment machine as disclosed is designed and configured for extracorporeal blood treatment, preferably intermittent or ambulatory, in particular hemodialysis. It has a container receptacle with a solvent inlet and a solution outlet. A container, configured according to at least one aspect of the preceding description, is inserted into the container receptacle. The container space of the medical container holds a medical, in particular alkalizing, dry substance. The inlet of the container is fluidically connected to the solvent inlet of the container receptacle, and the outlet of the container is fluidically connected to the solution outlet of the container receptacle.In this way, the solvent can be supplied to the container space via the inlet, the dry substance can be brought into contact with the solvent and dissolved in the container space, and the medical, especially alkalizing, solution can be provided to a dialysis fluid circuit of the extracorporeal blood treatment machine at the outlet.

[0058] A method for manufacturing a medical insert container that can be filled or is filled with a medical, in particular alkalizing, dry substance, and which is intended and designed for use with an extracorporeal blood treatment machine and for providing a medical, in particular alkalizing, solution, has at least the following steps:

[0059] Injecting or inserting a blank into a cavity of a stretch blow molding machine; and

[0060] Stretch blow molding of a one-piece base body of the medical insert container from the blank, wherein the stretch blow molded base body has a container space for receiving the dry substance, an inlet for connection to a solvent inlet of the extracorporeal blood treatment machine and an outlet for connection to a solution outlet of the extracorporeal blood treatment machine.

[0061] According to further training, the procedure has the following steps: BV1185P-WO-0008 2024P00044WO

[0062] 10 / 26

[0063] Automated transfer of the base body to a filling station, preferably located at the stretch blow molding machine, and

[0064] Automated filling of the base body with the medical dry substance via the inlet or outlet of the base body, using the filling station. By locating the filling station at the stretch blow molding machine, transport distances can be reduced, as the production of the base body and its filling take place at the same location. The automated transfer can, for example, be robot-assisted.

[0065] According to a further development, the stretch blow molding of the base body also results in the formation of a coupling element or coupling section, preferably an external thread, for fastening, preferably for screwing, a closure cap.

[0066] According to further training, the procedure has one step:

[0067] Sealing an opening of the inlet and / or outlet, preferably using an adhesive or sealing film.

[0068] According to further training, the process after filling or sealing has one step:

[0069] Sealing at least the inlet or outlet used for automated filling, preferably both the inlet and outlet, with a cap, preferably by screwing the cap onto the inlet or outlet. Preferably, the cap has a tamper-evident seal that is activated after sealing. The tamper-evident seal provides a high level of security and effective control against unintentional or premature opening of the container, thereby ensuring the authenticity and quality of the dry substance filled into the container.

[0070] According to further training, the blank has only a single, first opening through which it is subjected to pressure during stretch blow molding, whereby the first opening of the blank already has a specified diameter before stretch blow molding BV1185P-WO-0008 2024P00044WO

[0071] 11 / 26 and a coupling element or coupling section as intended, in particular an external thread, or wherein the first opening of the blank is formed as the inlet or outlet of the base body only by stretch blow molding.

[0072] According to disclosure, the process has one of the following steps:

[0073] Perforating a second opening on the blank during stretch blow molding, wherein this second opening is formed by the stretch blow molding as the outlet or as the inlet, or

[0074] Forming the outflow or inflow without an opening during stretch blow molding.

[0075] In the second case, a second opening is preferably formed by means of a subsequent perforation, at the latest when the medical insert container is placed in or when the medical insert container is used in the insert container receptacle, for example by means of a dome.

[0076] Brief description of the characters

[0077] The disclosure is explained in more detail below with reference to preferred embodiments and Figures 1 to 12. These show:

[0078] Figure 1 shows a section of an extracorporeal blood treatment machine with a insert container receptacle and an insert container inserted therein according to a first embodiment in a side view;

[0079] Figure 2 shows the insert container according to Figure 1 in its unopened state, in the same side view;

[0080] Figure 3 shows the insert container according to Figure 2, in a top view;

[0081] Figure 4 shows a cap of the insert container according to Figures 1 to 3, with the cover opened, in perspective view;

[0082] Figure 5 shows the closure cap according to Figure 4 in an inside view; BV1185P-WO-0008 2024P00044WO

[0083] 12 / 26

[0084] Figure 6 shows a blank of a basic body of an insert container according to a second embodiment, in a side view;

[0085] Figure 6a shows an alternative blank of the base body of the insert container according to the second embodiment, in a side view;

[0086] Figure 7 shows a base body of the insert container stretch-blown from the blank according to Figure 6 or according to Figure 6a, with inlet, container space and outlet, in a side view;

[0087] Figure 8 shows the insert container of the second embodiment with the base body according to Figure 7 and a closure cap screwed onto its outlet, in a side view;

[0088] Figure 9 shows the insert container according to Figure 8 with a medical dry substance contained in the container space, in a side view;

[0089] Figure 10 shows the insert container according to Figure 9 with a cap screwed onto the inlet, in a side view;

[0090] Figure 11 shows the insert container according to Figure 10 in intended operation with solvent supplied via the inlet, the medical dry substance dissolved in the container space, and the medical solution provided at the outlet, in a side view; and

[0091] Figure 12 shows a method for manufacturing an insert container according to Figure 10, according to an exemplary embodiment.

[0092] The figures are schematic and intended only to aid in understanding the revelation. Identical elements are marked with the same reference symbols. BV1185P-WO-0008 2024P00044WO

[0093] 13 / 26

[0094] Features of different designs can be interchanged.

[0095] Detailed description of preferred embodiments

[0096] Figure 1 shows an extracorporeal blood treatment machine 1, in particular a dialysis machine, and in particular a hemodialysis machine, which in the illustrated embodiment is designed and configured for intermittent or outpatient extracorporeal blood treatment of a patient's blood. A receptacle 4 of the blood treatment machine 1 is shown. A receptacle 2 of the blood treatment machine 1, as described in the disclosure, is received in the receptacle 4 and fluidically connected to it. The receptacle is filled with an alkalizing bicarbonate dry substance 14.

[0097] The insert container 4, together with the insert container 2, forms a section of a mixing unit of the blood treatment machine 1. This unit mixes ultrapure water and the alkalizing dry substance 14 to produce an alkalizing solution 36 (see Figure 11). This solution is then supplied to a dialyzer fluid circuit of a dialyzer (both not shown) of the blood treatment machine 1. The dialyzer fluid circuit runs through the dialyzer via a dialyzer fluid inlet and a dialyzer outlet. An extracorporeal blood circuit of the dialyzer runs via a blood inlet and a blood outlet on one side of the dialyzer. The dialyzer fluid circuit and the extracorporeal blood circuit are separated within the dialyzer by a semipermeable dialyzer membrane. This membrane removes urea and water from the blood in a known manner, allowing them to pass into the dialyzer fluid.

[0098] The insert container 4, as shown in Figure 1, has a solvent inlet 6 on its upper side, through which the solvent (pure water) is supplied. Accordingly, the insert container 2 has an inlet (hidden by the solvent inlet 6 in Figure 1) that is coupled to and fluidically connected to the solvent inlet 6. On its lower side, the insert container 4 has a solution outlet 8, through which the solution dissolved in the insert container 2 by dissolving the BV1185P-WO-0008 2024P00044WG contained therein is discharged.

[0099] 14 / 26

[0100] Dry substance 14 is prepared, alkalizing solution is provided.

[0101] Accordingly, the insert container 2 has an outlet 12 which is coupled to and fluidically connected with the solution outlet 8. Adjacent to the solvent inlet 6 and / or adjacent to the solution outlet 8, the insert container 2 may have elastic sections that allow the solvent inlet 6 and / or the solution outlet 8 to deflect when the insert container 2 is placed into the insert container receptacle 4.

[0102] Figure 2 shows the insert container 2 according to Figure 1 in a non-inserted state and with the inlet 10 and outlet 12 each closed. The insert container 2 has a base body 16 made of stretch-blown PET, which, as disclosed, is a single piece. This means that the base body 16, comprising the inlet 10, a container chamber 18 and the outlet 12, is manufactured without any joining step / joining point.

[0103] In the illustrated embodiment, the base body 16 has an approximately circular cylindrical shape, although alternative shapes, in particular a cuboid shape, are of course also possible, for example to improve stackability and transportability (see Figures 7 to 11).

[0104] For better handling and to stiffen the container space 18, the wall of the container space 18 is provided with full-length (stretch-blown) beads 20.

[0105] The inlet 10 is closed due to stretch blow molding. This means that, in the illustrated, unopened state of the insert container 2, it has no opening. Instead, the inlet 10 is closed at its end by a flat wall 22 that was formed / remained during the stretch blow molding process.

[0106] Alternatively, the inlet can be designed in a pre-opened form, achieved, for example, through an additional machining step such as cutting or drilling. In this case, a connection port or adapter port 21 on the inlet 10 is fitted with an additional sealing cap cover, analogous to the sealing cap cover 28 of the BV1185P-WO-0008 2024P00044WO

[0107] 15 / 26

[0108] Connection ports or adapter ports 23 are provided at the outlet 12 in Fig. 2. This (respective) sealing cap cover can be designed in the form of a tamper-evident seal.

[0109] The dry substance 14 is contained in the container compartment 18. The container compartment 18 is transparent, so that the fill level of the insert container 2 with dry substance 14 is clearly visible and the dry substance 14 can also be inspected, for example with regard to particle size, consistency, impurities or color.

[0110] The lower outlet 12 is closed by a screwed-on cap 24 of the insert container 2, which is preferably injection molded from polyethylene (PE), or alternatively from polypropylene (PP) and can be provided, for example, as a standard or purchased part, which keeps the manufacturing costs for the insert container 2 low.

[0111] The cap 24 has a tamper-evident seal 26 in the form of a locking ring that can only be opened by destructive means. This ring engages a thread (not shown) of the drain 12 onto which the cap 24 is screwed. This ensures that any unauthorized prior opening can be detected. This contributes to quality assurance in the provision of the solution and thus to patient safety.

[0112] Figure 3 shows the insert container 2 in a top view, that is, in a plan view of the inlet 10 which is closed by the flat wall 22. The wall 22 is dimensioned so thinly that when the insert container 2 is inserted into the upper insert container receptacle 4, it is perforated / pierced by a dome of the solvent inlet (6, cf. Figure 1), thereby forming the fluidic connection between the inlet 10 and the solvent inlet.

[0113] Alternatively, the inlet 10 can have a screw thread, or the inlet 10 is designed with a screw thread. In this case, an opening is first created during the manufacturing process, which will later be used in the medical device BV1185P-WO-0008 2024P00044WG.

[0114] 16 / 26

[0115] The container, for example during hemodialysis, allows the inflow of ultrapure water. A further sealing cap, as described above for closing the outlet opening 12 by means of the corresponding sealing cap 24, is then screwed onto the aforementioned screw thread of the inlet 10. This additional sealing cap ensures, on the one hand, the connection to the blood treatment / dialysis machine and, on the other hand, by means of a frit and / or a sieve element, ensures that the filled dry substance cannot escape. This further sealing cap can be designed technically analogous to sealing cap 24.

[0116] Figure 4 shows the end cap 24 according to Figures 1 and 2 in a single, perspective view. The end cap 24 has a main body with circumferential ribbing to improve handling when screwing it onto or off the drain 12. A hinged cover cap 28 is connected to the main body.

[0117] Figure 5 shows the closure cap 24 according to Figure 3 with the cover cap 28 opened, in a view from the perspective of the outlet 12 of the base body of the insert container 2. On its inner side, the closure cap 24 has a filter 30 or a "frit" that spans an opening cross-section of the closure cap 24 and is designed to retain undissolved dry matter 14 and any impurities. In this way, the purity of the provided solution is ensured. Furthermore, it prevents subsequent or delayed dissolution of the dry matter downstream of the solution outlet 8, i.e., in the inflow to the dialysis fluid circuit, so that the solution is supplied to the dialysis fluid circuit with a defined composition.

[0118] With reference to Figures 6 to 10, Figure 6a, and Figure 12, a second embodiment of an insert container 102 according to the disclosure and a method for its manufacture are described below. BV1185P-WO-0008 2024P00044WG

[0119] 17 / 26

[0120] The process serves to produce a medical insert container 102 filled with medical, in particular alkalizing, dry substance 14 according to figure 10 for an extracorporeal blood treatment machine 1 and to provide the medical solution 36 according to figure 11 and has a start step SO according to figure 12.

[0121] First, a basic body 116 of the insert container 102 is produced according to figure ? from an insert container blank 102', which is designed according to figure 6.

[0122] The production of the base body can generally be carried out by means of injection stretch blow molding directly from a provided granulate or by means of stretch blow molding from the provided preform / from the provided blank 102'.

[0123] In the embodiment shown according to Figures 6 to 10, Figure 6a and Figure 12, the base body is produced by stretch blow molding, so that the process includes a step prior to stretch blow molding of providing / inserting S1 of the blank 102' (material PET) into a cavity of a plastic stretch blow molding machine.

[0124] The blank 102' has a preformed inlet 110, as shown in Figure 6. Preformed here means that the inlet 110 already has the intended diameter and external thread 40 of the subsequent stretch-blown base body 116, as shown in Figure 7. The inlet 110 of the blank 102' is thus already formed like the inlet 110 of the subsequent stretch-blown base body 116 before stretch blow molding and is not modified during the stretch blow molding process. A reservoir 118' of the blank 102' extends from the preformed inlet 110 in a bulbous, semi-spindle, or conical shape. The length of the container space 118' of the blank 102' is preferably dimensioned such that it does not extend beyond the outermost edge of the later, stretch-blown outlet 12 of the base body 116.

[0125] Figure 6a shows an alternative blank 202' to blank 102' according to Figure 6. Unlike blank 102' according to Figure 6, blank 202' has a BV1185P-WO-0008 2024P00044WG

[0126] 18 / 26

[0127] The container chamber 218' is in the shape of a trapezoid of revolution. An inlet 210' of the blank 202' is preformed as a cylindrical sleeve and has a smaller diameter and no external thread. Unlike the blank 102' shown in Figure 6, the inlet 210' of the blank 202' is only expanded to the intended diameter of the inlet 110 of the base body 116 shown in Figure 7 during stretch blow molding. Similarly, the external thread 40 of the inlet 110 of the base body 116 shown in Figure 7 is also only formed during stretch blow molding. The length of the container chamber 218' of the blank 202' is preferably dimensioned such that it does not protrude beyond the outermost edge of the later stretch-blown outlet 12 of the base body 116.

[0128] The next step is stretching the blank 102' into the one-piece base body 116 of the medical insert container 102 according to Figure 7, wherein the base body 116 then has the container space 118 for receiving the dry substance 14, the inlet 110 with external thread 40 for connection with the solvent inlet 6 of the extracorporeal blood treatment machine 1 and the outlet 12 for connection with the solution outlet 8 of the extracorporeal blood treatment machine 1.

[0129] The PET material allows for thinner wall thicknesses in stretch blow molding than, for example, polypropylene, so that with a given volume of the container space 118 / of the dry substance 14, a weight reduction of 50% of the PET stretch blow molded base body 116 can be achieved.

[0130] In the same step, the formation of the external thread 40 at the outlet 12 of the base body 116 also apparently occurs incorrectly during the stretching process S2.

[0131] The next step involves manually or automatically closing S3 of the drain 12 by screwing on the closure cap 24 as shown in Figure 8.

[0132] This is followed by a step automated transfer S4 of the stretch-blown base body 116 according to Figure 7 to a filling station located on the stretch blow molding machine, as well as a step automated - at least partial - filling S5 of the BV1185P-WO-0008 2024P00044WG

[0133] 19 / 26

[0134] Base body 116 with the medical dry substance 14 through the inlet 110 of the base body 116, by means of the filling station.

[0135] The insert container 102 now has the condition shown in Figure 9.

[0136] The next step is to close S6 of the inlet 110 used for automated filling by screwing on a sealing cap 24. The insert container 102 according to Figure 10 is now thus manufactured and ready for use with the blood treatment machine 1.

[0137] The next step is the end of the SE procedure.

[0138] Figure 11 schematically shows the insert container 102 manufactured according to the disclosure as shown in Figure 10 in operation of the blood treatment machine 1. The insert container 102 is inserted into the insert container receptacle 4, its inlet 110 is fluidically connected to the solvent inlet 6 of the insert container receptacle 4, and its outlet 12 is fluidically connected to the solution outlet 8 of the insert container receptacle 4, so that, as shown in Figure 11, the solvent 34 is supplied to the container chamber 118 via the inlet 10, the dry substance 14 comes into contact with the solvent 34 in the container chamber 118, and the medical solution 36 is made available ready for use at the outlet 12.

[0139] BV1185P-WO-0008 2024P00044WO

[0140] 20 / 26

[0141] Reference symbol list

[0142] 1 extracorporeal blood treatment machine

[0143] 2; 102 deployment containers

[0144] 102'; 202' blank

[0145] 4 Insert container attachment

[0146] 6 Solvent feed

[0147] 8 Solution process

[0148] 10;110 Inflow

[0149] 110; 210' Inlet blank

[0150] 12 Procedure

[0151] 14 dry matter

[0152] 16; 116 Basic body

[0153] 18; 118 Container space

[0154] 118'; 218' Container space blank

[0155] 20 groove

[0156] 21 Connection Z-adapter port on the inlet

[0157] 22 wall

[0158] 23 Connection Z-adapter port at the drain

[0159] 24 Cap

[0160] 26 Tamper-evident seal

[0161] 28 Cover cap / Closure cap cover

[0162] 30 filters

[0163] 32 blanks

[0164] 34 Solvents (Ultrasonic Water)

[0165] 36 Solution

[0166] 38 Filling scale

[0167] 40 external threads

[0168] SO Step Start Procedure

[0169] S1 Step Insert blank

[0170] S2 step stretching blisters

[0171] S3 Step Close Expiry BV1185P-WO-0008 2024P00044WQ

[0172] 21 / 26

[0173] 54-step transfer to filling station

[0174] 55 steps Filling via inlet

[0175] Step 56: Closing the Inlet

[0176] SE End of procedure

Claims

BV1185P-WO-0008 2024P00044WG 22 / 26 Claims 1. Medical insert container (2; 102) for insertion into and fluidic connection with an insert container receptacle (4) of an extracorporeal blood treatment machine (1), which is designed and configured for blood treatment, wherein the insert container (2; 102) is designed and configured for receiving and dissolving a medical, in particular alkalizing, dry substance (14), as well as for providing a medical, in particular alkalizing, solution (36), comprising: an inlet (10; 110) designed and configured for fluidic connection with a solvent inlet (6) of the insert container receptacle (4) and for supplying a solvent (34), a container chamber (18; 118) designed and configured to receive the dry substance (14) and to bring it into contact with the supplied solvent (34), and an outlet (12;112), which is provided and designed for fluidic connection with a solution outlet (8) of the insert container receptacle (4) and for providing the medical solution (36), characterized in that a basic body (16; 116) is formed from the container space (18; 118), the inlet (10; 110) and the outlet (12; 112), which is a single piece.; 2. Medical insert container (2; 102) according to claim 1 , characterized in that the base body (16; 116) comprises polyethylene terephthalate or is made of polyethylene terephthalate.

3. Medical insert container (2; 102) according to claim 1 or 2, characterized in that the wall thickness of the container space (18; 118) is less than 2 mm, preferably less than 1 mm.

4. Medical insert container (2; 102) according to one of the preceding claims, characterized in that the base body (16; 116) is stretch blown or injection stretch blown. BV1185P-WO-0008 2024P00044WG 23 / 26 5. Medical insert container (2; 102) according to one of the preceding claims, characterized in that an elastic container section adjacent to the inlet or outlet has an elasticity, in particular based on shape and wall thickness, which allows the inlet or outlet to spring back when the insert container (2; 102) is inserted into the insert container receptacle (4).

6. Medical insert container (2; 102) according to claim 4 or 5, characterized in that the inlet (110) and / or the outlet (12; 112) of the base body (16; 116), preferably both, are integrally stretch blow-molded or injection stretch blow-molded with a coupling element or coupling section, preferably with an external thread (40), which is provided and designed for coupling, preferably screwing, with a closure cap (24).

7. Medical insert container (102) according to one of claims 4 to 6, characterized in that a visual and / or haptic filling scale (38) is stretch blow-molded or injection stretch blow-molded in one piece with the container space (118).

8. Medical application container (2) according to one of claims 4 to 7, characterized in that the inlet (10) and outlet (12) of the base body (16) have different diameters, the one with the larger diameter being open and provided for filling the container space (18) with the dry substance (14).

9. Medical insert container (2) according to one of claims 4 to 8, characterized in that the inlet (10) and the outlet (12) of the base body (16) have different diameters, wherein the one with the smaller diameter, in particular the inlet (10), is closed and is provided for an opening, in particular perforation or punching by a dome, when inserted into the insert container receptacle (4).

10. Medical insert container (102) according to one of the preceding claims, characterized in that the container space (118) is cuboid in shape. BV1185P-WO-0008 2024P00044WG 24 / 26 11. Medical application container (2; 102) according to one of the preceding claims, characterized in that the dry substance (14) is contained in the container space (18; 118).

12. Medical insert container according to one of the preceding connections, characterized in that a tamper-evident seal (26) is provided at the inlet or at the outlet (12), or at both.

13. Extracorporeal blood treatment machine (1) designed and configured for extracorporeal blood treatment, comprising: an insert container receptacle (4) with a solvent inlet (6) and a solution outlet (8), and an insert container (2) according to claim 11, which is inserted into the insert container receptacle (4) and whose inlet (10) is fluidically connected to the solvent inlet (6), and whose outlet (12) is fluidically connected to the solution outlet (8), such that the solvent (34) can be supplied to the container chamber (18) via the inlet (10), the dry substance (14) can come into contact with the solvent (34) in the container chamber (18), and the medical solution (36) can be provided at the outlet (12).

14. Method for producing a medical insert container (102) that can be filled or filled with a medical, in particular alkalizing, dry substance (14), which is designed and configured for use with an extracorporeal blood treatment machine (1) and for providing a medical, in particular alkalizing, solution (36), comprising one step: Injection or insertion (S1 ) of a blank (102'; 202') of an insert container (102) into a cavity of a plastic stretch blow molding machine, characterized by a step Stretch bladders (S2) of a one-piece base body (116) of the medical insert container (102) with a container space (118) for receiving the dry substance (14), an inlet (110) for connection with a solvent inlet (6) of the extracorporeal blood treatment machine (1) and an outlet (12) for BV1185P-WO-0008 2024P00044WÖ 25 / 26 Connection to a solution outlet (8) of the extracorporeal blood treatment machine (1).

15. Method according to claim 14, characterized by steps: Automated transfer (S4) of the base body (116) to a filling station located on the plastic stretch blow molding machine, and Automated filling (S5) of the base body (116) with the medical dry substance (14) through the inlet (110) or outlet (12) of the base body (116) by means of the filling station.

16. Method according to claim 15, characterized by one step Seal (S6) at least the inlet (110) or outlet (12) used for automated filling with a sealing cap (24).

17. A method according to any one of claims 14 to 16, wherein the blank (102'; 202') has only one first opening (110; 210') through which it is pressurized during stretch blow molding (S2), wherein the first opening (110) of the blank (102') is already formed with a defined diameter and a defined coupling element or coupling section, in particular an external thread (40), before stretch blow molding (S2), or wherein the first opening (210') of the blank (202') is only formed as the inlet (110) or as the outlet by stretch blow molding (S2), characterized by one of the steps Perforating (S6) a second opening in the blank (102'; 202') during stretch blow molding (S2), wherein this second opening is formed by the stretch blow molding (S2) as the outlet (12) or as the inlet, or Forming (S7) the outflow or inflow without opening during stretch blowing (S2).

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