Multi-chamber bag.

(54) Title: BAG OF MULTIPLE CAMERAS. (54) Title: MULTI-CHAMBER BAG.

(57) Summary

The present invention relates to a method of dissolving / mixing a concentrate in / with a fluid in a multi-chamber bag and to a method of producing a medical fluid, in particular a dialysis fluid, in a multi-chamber bag. Furthermore, the present invention relates to a multi-chamber bag by itself. In all the modalities, at least two different concentrates can be included separately in powder form, in liquid form or in semi-liquid paste form for dissolution in a fluid in the multi-chamber bag. The present invention also relates to the use of the multi-chamber bag in hemodialysis or peritoneal dialysis of a hemodialysis or peritoneal dialysis device, in particular as a container for a dialysis fluid in a hemodialysis or peritoneal dialysis device.

(57) Abstract

The present invention relates to a method of dissolving / mixing of a concentrate in / with a fluid in a multi-chamber bag and to a method for the production of a medical fluid, in particular a dialysis fluid, in a multi-chamber bag. Moreover, the present invention relates to a multi-chamber bag itself. In all embodiments at least two different concentrates can be included separately in powder form, liquid form or semi-liquid slurry form for dissolution in a fluid in the multi-chamber bag. The present invention also relates to the use of the multi-chamber bag in haemodialysis or peritoneal dialysis or a haemodialysis or peritoneal dialysis device, in particular as a container for a dialysis fluid in a haemodialysis or peritoneal dialysis device.

MULTIPLE CAMERA BAG

FIELD OF THE INVENTION

The present invention relates to a method of dissolving / mixing a concentrate in / with a fluid in a multi-chamber bag and to a method for the production of a medical fluid, in particular a dialysis fluid, in a multi-chamber bag . Furthermore, the present invention relates to a multi-chamber bag per se. In all modalities, at least two different concentrates can be included separately in powder form, in liquid form or in a semi-liquid paste form for dissolution in a fluid in the multiple chamber bag. The present invention also relates to the use of the multi-chamber bag in hemodialysis or peritoneal dialysis or in a hemodialysis or peritoneal dialysis device, in particular, as a container for a dialysis fluid in a hemodialysis or peritoneal dialysis device.

BACKGROUND OF THE INVENTION

Hemodialysis or peritoneal dialysis devices are known in various versions. The exchange of substances between the blood and the dialysis fluid takes place in a dialyzer that has a first flow path for the blood and a second flow path for the dialysis fluid, where both flow paths are normally separated one from another by a semipermeable membrane. The first flow path is part of an out-of-body blood circulation system with a feeding line and a return line for blood and also additionally a pump that supports blood flow. The second flow path is connected to the equipment that feeds and withdraws the dialysis fluid.

In addition to so-called single-path systems in which continuously fed dialysis fluid passes through the dialyzer only once and is then discarded, so-called batch systems are known. The DE

fifteen 665 C2 describes such a hemodialysis device that operates with a fixed volume container sealed against the atmosphere which is completely filled with fresh dialysis fluid prior to the start of treatment. During its operation, the fluid is pumped out of the container through the dialyzer and the used fluid is passed back to the container.

Fresh and used dialysis fluids are not allowed to mix in the case of a known hemodialysis device by removing the dialysis fluid from the top of the container and returning it to the bottom area of ​​the container.

Underlying the fresh dialysis fluid with the used dialysis fluid remains stable through maintaining a vertical temperature gradient in the container from top to bottom.

The container consists of glass, which, due to the pore-free surface, is superior, with respect to hygiene and bacteriology, to other materials. Furthermore, the glass is highly resistant to the chemical agents that come into consideration, can be satisfactorily cleaned and is physiologically inert. However, such a reusable glass container repeatedly shows disadvantages because the glass container needs to be disinfected before the renewed dialysis treatment.

US 4,767,526 similarly describes a dialysis device in which the dialysis fluid is provided in a container. In order to avoid infection, it is proposed to cover the container with a flexible bag that is discarded after use.

Flexible plastic bags consisting of two films that lie flat with respect to each other and are attached to each other at their edges are known as containers for the preservation of medical fluids.

D 19825158 Cl similarly describes a disposable bag for a hemodialysis device to a device for peritoneal dialysis which preferably has a concentrate for the preparation of a dialysis fluid. This bag can consist of a chamber in which the fluid is placed under the fresh dialysis fluid in the course of the dialysis process.

Alternatively, the disposable bag can also contain a film that divides the bag into two chambers, where fresh dialysis fluid is present in one chamber of the bag and the used fluid passes into the other chamber during the dialysis process.

A disadvantage of the aforementioned glass containers is that rapid reuse is not possible due to the laborious disinfection step. However, disposable bags, which do not have this disadvantage, have not yet solved the problem that in case of introducing this granular material to be dissolved in water, the different constituents of the granular material react with each other during the storage of the bag. including granular material, with the result that there is no storage stability after a certain period of time. Furthermore, dialysis fluids that are prepared by dissolving the granular material containing all the necessary constituents frequently have the problem that, as a result of undesired reaction of the different constituents, not all the granular material dissolves.

Both of the aforementioned problems frequently lead to a degradation or agglomeration of at least one of the provided concentrates. Additionally, it is important to control the pH accordingly while the solvent is being poured into the bag with granular material, so that undesired precipitation is avoided during the dissolution of the granular material in the fluid. If this problem occurs, the dialysis fluid is not suitable for hemodialysis or peritoneal dialysis and must be discarded along with the bag.

In addition to glucose, or other ingredients that are unable to contribute to the electrical conductivity of a fluid dissolved in it, and the physiologically essential salts, or ions, dialysis fluids must have a pH in the neutral range. A pH in the neutral range is obtained by adding an acidic and a basic component. These acid and basic components must necessarily be physiologically compatible. Therefore, carbonate salts, for example sodium hydrogen carbonate, are preferably the basic regulatory component. The solution must contain calcium and magnesium ions, in addition to sodium and potassium ions, as physiologically essential ions. A dialysis fluid is most often prepared from an individual concentrate that is put into the bag in the case of DE 198

158. In such concentrates containing easily soluble calcium or magnesium salts and, a basic regulatory component, a (bi) carbonate salt is stored for a long time, thus the problem arises, at least under atmospheric humidity conditions, that the components they can react with each other and thus form poorly soluble calcium or magnesium carbonate. Similarly, poorly soluble calcium or magnesium carbonate precipitates from a solution at a pH that has not been defined in the ideal range of preferably <pH 8. Therefore it is disadvantageous to introduce a concentrate with all the physiologically necessary essential components in a bag together, since such systems cannot be stored for a long time since due to the aforementioned problems and during dissolution in the fluid there is a higher pH than 8 in solution areas, with the result that unwanted precipitation occurs.

SUMMARY OF THE INVENTION

Therefore, it is an object of the present invention to provide a method for dissolving / mixing a concentrate in / with a fluid, a method for the production of a medical fluid by dissolving the concentrates or a disposable bag that has, among others, the following advantages:

- High user-friendliness through an all-in-one concept and high application security;

- High flow rates during filling with fluid;

Low use of materials, ·

Rapid / optimal dissolution of concentrates;

Avoid contamination through laborious connection of individual components for solution preparation;

- Storage stability of raw materials (that is, without decomposition, degradation or agglomeration of glucose, without conversion of dicarbonates to CO₂, without calcium carbonate precipitation);

Controlled preparation of a solution from dry concentrates by sequential dissolution of the different components of the dry concentrate, where the formation of calcium carbonate precipitations can be avoided and the desired pH can be defined;

Storage stability of the solution after preparation from dry concentrates, without calcium carbonate precipitation occurring during storage and when the result that the pH remains stable in the solution;

Find a way to measure by standard methods whether a concentrate that does not contribute to the electrical conductivity of a medical solution is dissolved in a fluid (explanation: Usually the concentration of a compound in solution is measured by its conductivity since in the case of electrolyte concentration is proportional to the change in conductivity; however some substances essential for medical solutions cannot be measured by this method, since they do not contribute to conductivity).

BRIEF DESCRIPTION OF THE FIGURES

Five different embodiments of the bag according to the invention or a bag that can be used in the method according to the invention are described in detail below with reference to the drawings.

They are shown in:

Figure 1 a section through a bag with a type A chamber and two type B chambers, where the separating device is present in the form of a tear seam.

Figure 2 a section through a bag with a type A chamber and two type B chambers, where the separating device or type B chambers are present in the form of a bag which has a predetermined breaking point in the form of a tear seam.

Figure 3 a section through a bag which has a type A chamber and four type B chambers, where the separating device is present in the form of a tear seam.

Figure 4 a section through a bag having a type A chamber and three type B chambers, where wherein the separating device or type B chambers are present in the form of internal bags having a tear seam as a point of default break.

Figure 5 a bag with a type A chamber and three type B chambers, where the type B chambers are present separated from the type A chamber by a separating device in the form of a tear seam.

Figure 6 a section through a bag which has a type A chamber and four type B chambers, where the separating device is present in the form of a tear seam.

Figure 7 a section through a bag which has a type A chamber and four type B chambers, where the separating device is present in the form of a tear seam.

DETAILED DESCRIPTION OF THE INVENTION

In a first embodiment of the present invention, the 5 mentioned objectives are achieved by a method of dissolving / mixing a concentrate in / with a fluid that has the following steps:

(a) provision of a concentrate (5) in a chamber of a multiple chamber bag, where the chambers (2, 3) of the multiple chamber bag are separated from each other by a separation device (4, 4a), and (b) introduction of a fluid into one of the chambers (2,

3) of the multi-chamber bag, (c) rupture of the separation device (4, 4a) between the chambers (2, 3) of the multi-chamber bag introducing the fluid, and (d) solution / mixture of concentrate ( 5) in / with the fluid.

In other words, the aforementioned method is a method for preparing a dialysis fluid with the steps previously named (a) and (d). In a preferred embodiment, the dialysis fluid is a sterile dialysis fluid.

The method of the first embodiment in the following is referred to as the first method according to the invention.

In a further embodiment of the present invention, the concentrate is preferably provided in a standard chamber

B of the multiple chamber bag comprising a type A chamber and a type B chamber. It is preferred that the first chamber multiple chamber bag contain at least two, more preferably three, and most preferably four type B chambers. Preferably two of the type B chambers are chambers that open at the same time or one opens before the other opens when the fluid is introduced, preferably into the type A chamber. Preferably type A chamber does not contain a concentrate, and a type B chamber contains a first concentrate as defined below, and a type B chamber contains a concentrate with the acid component as defined below. It is preferred that the chamber with the first concentrate be opened before or at the same time as the chamber containing the concentrate with the acid component is opened. A third or fourth type B chamber may contain a concentrate with the basic component as defined below. It is further preferred that these chambers be opened after the first and second chambers in order to avoid decomposition, degradation or agglomeration of the first concentrate.

A further embodiment of the present invention relates to a method for the production of a medical fluid having the following steps:

(e) provision of a multiple chamber bag (1) comprising a type A chamber (2), a first type B chamber (3) and a second type B chamber (3a), wherein the first type B chamber comprises a first concentrate (5) which does not contribute to the electrical conductivity of the medical fluid and the second chamber type B comprises a second concentrate (5a) which contributes to the electrical conductivity of the medical fluid, wherein the first type B chamber and the second type B chamber are each separated from the type A chamber by separation devices (4, 4a),

<td></td><td>(F)</td><td>Introduction of</td><td>a fluid in</td><td>the</td><td>type A camera,</td><td></td>

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<td></td><td>cameras</td><td>introducing the</td><td>fluid and</td><td></td><td></td><td></td>

<td></td><td>(h)</td><td colspan="2">dissolution / mixing of</td><td colspan="2">concentrated in / with</td><td>the</td>

fluid, characterized in that by the introduction of the fluid the separation device of the first type B chamber breaks before or, more preferably, at the same time as the separation device of the second type chamber breaks.

B.

The method for the production of a medical fluid mentioned above is referred to herein as the second method according to the present invention.

A medical fluid within the meaning of this invention is a fluid that is physiologically compatible, such as a dialysis fluid.

In the second method, it is preferred that the first type B chamber is separated from the second type B chamber by means of an interspace that is constituted by a part of the type A chamber, that is, the separation device of both type B chambers separating these chambers. Type A camera individually.

All of the concentrates of the present invention can be concentrated in powder, liquid or semi-liquid paste form, preferably in powder form.

All preferred embodiments of the present invention are referred to as belonging to the first and second method, unless otherwise stated.

The differentiation of the cameras of the multiple camera bag into camera type A and camera type B must

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second method. These two / three chambers can be the same in one embodiment according to the invention, or carry out the same function in the bag, and different in another embodiment according to the invention, as seen from the following embodiments . If, in the following modalities, there is more than one type B camera, it is then covered cameras that have the same mode of operation and can have the same shape, but also different shapes.

Water, in particular RO water (reverse osmosis), is preferably used as a fluid. However, any differently demineralized water that is suitable for the preparation of physiologically compatible fluids can also be used.

In addition to the type A camera or cameras and the type B camera or cameras, the multi-camera bag may also comprise additional type B cameras. In preferred embodiments, the multi-chamber bag contains one type A chamber 15 and a total of two type B chambers or one type A chamber and a total of three or four type B chambers. Each chamber as well also the additional type B chambers, is separated from the other chambers by separation devices. The separation devices are broken when introducing the fluid. Preferably each of the type B chambers has its own separation device such that between the type B chamber separation devices there is at least a portion of the type A chamber.

In the first method, a Type A chamber can contain a concentrate in powder, liquid, or semi-liquid paste form. In the first method, the type B chamber of the multi-chamber bag can likewise contain a concentrate in powder, liquid or semi-liquid paste form. In the case of the second method, it is preferred that type A chamber does not contain a concentrate, but preferably both type B chambers comprise a concentrate. In the first and second method, if the multi-chamber bag contains one or more additional type B chambers, it is preferred that these also contain a concentrate in powder, liquid or semi-liquid paste form.

If the multi-chamber bag preferably contains a total of at least three chambers, concentrates of the same or different composition may be present therein. It is particularly preferred that the concentrates have different compositions. However, it is also conceivable that if there are a total of three or more chambers a concentrate of the same composition is present in two or more chambers.

It is particularly preferred in all the embodiments of the present invention that the multi-chamber bag comprises at least one first and second concentrates, as for example defined in the case of the second method, but is also preferred in the first embodiment. The first concentrate is therefore preferably a concentrate that does not contribute to the electrical conductivity of the resulting (medical) fluid. The second concentrate is therefore preferably a concentrate that contributes to the electrical conductivity of the resulting (medical) fluid. The first concentrate is therefore a substance that is not capable of dissociating in solution into anions and cations or is a substance that is present in such a low quantity that the contribution to conductivity is not characteristic.

These substances can be: pharmaceuticals, active ingredients, or in particular in the field of dialysis:

osmotics such as glucose, fructose, galactose, sorbitol, amino acids, polymeric osmotics such as maltodextrin, icodextrin, and polyethylene glycol, or acids such as citric acid, lactic acid, succinic acid, fumaric acid, and oxalic acid. The second concentrate is therefore a concentrate that comprises a compound that is capable of dissociating into anions and cations, such as for example electrolytes.

Due to the previously mentioned rupture of the separation devices between type A chamber and type B chambers, a resulting chamber is formed, the volume of which comprises the sum of the volumes of type A chamber and type B chambers. In this way, the granular material from the different chambers can dissolve in the fluid together through the introduction of the fluid, with the result that the separately stored concentrates come into contact with each other only when the fluid is prepared. In other words, due to the open rupture or rupture of the separation devices, a resulting chamber is formed in which all of the concentrates / concentrate are / are dissolved or dissolved in the solvent.

In a further embodiment, particularly in the first method of the present invention, the bag preferably comprises one type A chamber and two type B chambers, where each chamber contains a different concentrate from each of the other concentrates.

In case of the second method of the present invention, type A chamber does not contain a concentrate and both the first and second type B chambers contain different concentrates, namely the first and second concentrates mentioned above.

In a further embodiment of the present invention, the bag preferably comprises one type A chamber and three type B chambers, where each of the three type B chambers contains a different concentrate from each of the other concentrates. In this case one concentrate is preferably the first concentrate, and the other concentrates are concentrated as the second concentrate, but preferably different from each other.

It is particularly preferred that the bag contains two or more different concentrates (a first and one or more concentrates such as the second concentrate) of which are present separately in different chambers. The separation of the different concentrates has the advantage that the components of the concentrates do not affect each other, with the result that adequate storage stability is ensured. The second concentrate may be an acidic one-component concentrate or a basic component concentrate as defined below. The second concentrate is preferably a concentrate that comprises glucose or consists of glucose without any acidic components.

The concentrates can be present in liquid form dissolved in a liquid, preferably RO water or physiologically compatible water, but also in dry form as powder or granular material, as well as in the form of semi-liquid pasty concentrates. Particularly preferably, the concentrates are present in dry form or as semi-liquid pasty concentrates. Any physiologically compatible acid is conceivable as an acid component, with citric acid, hydrochloric acid, acetic acid, succinic acid, fumaric acid, malic acid, lactic acid and amino acids being preferred. Citric acid is used particularly preferably. The basic component, or regulatory component, is preferably a bicarbonate of an alkaline salt, preferably sodium hydrogen carbonate. The acid component concentrate may additionally contain physiologically compatible / necessary salts, such as sodium chloride, potassium chloride, calcium chloride, or magnesium chloride. In addition to the basic or regulatory component, the concentrate of the basic or regulatory component may also contain metal salts, preferably sodium chloride and / or potassium chloride. In a particularly preferred embodiment, the acid component concentrate contains sodium chloride, potassium chloride, calcium chloride, magnesium chloride, and citric acid. Most preferably, the acid component concentrate comprises potassium chloride, calcium chloride, magnesium chloride (preferably anhydrous), and citric acid. The base or buffer component concentrate preferably contains sodium chloride and sodium hydrogen carbonate. If the bag contains only two separate chambers, or two different concentrates in these chambers, then one or both concentrates may also contain glucose in addition to the components mentioned. To avoid unwanted decomposition of glucose during storage of the bag filled with concentrates it is particularly preferred that the bag contains a total of three or more chambers, with the result that there are three different concentrates present separately in different chambers.

Then, in this case of the first method, a concentrate can be introduced into chamber type A and the two additional concentrates in each case into a chamber type B.

Alternatively, the type A chamber can also remain unfilled (preferably in the second method) and the three different concentrates can be introduced into a total of three type B chambers. However, there may also be a total of five chambers, namely one type A chamber and four type B chambers, where type A chamber is kept unfilled and two type B chambers are filled with the same concentrate and both Additional type B chambers each contain an additional concentrate. The provision of three separate concentrates has the advantage that glucose does not have to be introduced into a chamber together with the acidic or basic concentrate or regulator. This is advantageous with respect to the resistance of the concentrates against decomposition, degradation or agglomeration of glucose during storage.

The proportions of acid to basic component should be chosen such that during the dissolution of the concentrates the pH is preferably below 8 but is above 6, preferably in the range of 6.5 to

7.8, more preferably in the range of 6.8 to 7.6, even more preferably in the range of 7 to 7.5. Too high a pH is disadvantageous since the calcium and magnesium salts precipitate as calcium carbonate or magnesium carbonate.

This is also the reason why calcium or magnesium salts should not be kept in the basic concentrate. Too low a pH is disadvantageous in the same way, since carbon dioxide is released from the hydrogen carbonate, which in turn leads to an increase in pH, which is disadvantageous for the reason previously mentioned.

If sodium hydrogen carbonate from the basic concentrate is used and citric acid is used as the acid component in the acid concentrate, then the citric acid and sodium hydrogen carbonate will preferably be present in a molar ratio range of 0.5: 40 to 2: 40 .

The aforementioned amounts of the components mentioned in the concentrates should be chosen in such a way that when adding a certain amount of solvent, in particular physiologically compatible water, the specific electrical conductivity of the resulting total solution falls in the range of 10.00 to 17.00 mS / cm, preferably 11.00 to 15.00 mS / cm, even more preferably 13.00 to 14.00 mS / cm, and most preferably 13.66 mS / cm. Electrical conductivity in the range mentioned above is important for the preparation of medical fluids such as a dialysis fluid. Electrical conductivity is measured by a conductivity meter at a fluid temperature of 20 ° C and a pressure of 1013 mbar.

The bag (multi-chamber bag) in the aforementioned methods is preferably a single-film bag preferably consisting of a flexible plastic film. In a further embodiment, the film bag is preferably formed from a single-layer or multi-layer plastic film, where the innermost film layer is a weldable film layer. The separating device between type A chamber and type B chambers is preferably formed into a tear seam by welding two opposing layers of internal films into the bag. Accordingly, in this embodiment, a tear seam is understood to mean a linear welded joint of two opposite inner sides of the bag. The tear seam preferably goes in the bag such that type B chamber (s) is / are present separate from type A chamber and separate from additional type B chambers, preferably in the manner defined above, i.e., the Inner space of the chambers is not connected. This is probably true for several possibly present Type B cameras. However, when the fluid is introduced, the separation device or devices are / are broken, with the result that the previously separated spaces are connected.

In a further embodiment of the present invention, it is preferred that the fluid be introduced into the type A chamber.

By introducing the fluid into the type A chamber, a force (swelling pressure) acts on the tear seam that separates the chambers from each other, with the result that the tear seam opens along the linear welded joint and a resulting chamber is formed whose volume substantially comprises the sum of the volumes of all the chambers. The term substantially is used herein to reflect the circumstance that, as a result of the presence of a tear seam in the multi-chamber bag, there may be slight discrepancies between the volume of the resulting bag and the sum of the volumes of the chambers. of the multi-chamber bag compared to the resulting bag (after opening of the tear seam).

In a preferred embodiment of the present invention, the multiple chamber bag according to the first and second methods all comprise all four type B chambers. The first and second type B chambers before

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preferably the acid component concentrate. The third and fourth chambers preferably both comprise a second concentrate which is a concentrate of the basic component.

In a further alternative embodiment of the first method mentioned above, type B chambers is / are formed by an internal bag within type A chamber which represents the separation device. In other words, within the type A chamber, the outer boundary of which represents substantially the exterior of the multi-bag chamber, there are additional chambers represented by the type B chambers.

In this additional alternative modality with the so-called internal pockets that represent type B chambers, the fluid is preferably introduced into this internal layer. Furthermore, the fluid can also be introduced into the Type A chamber, in order to possibly introduce a fluid there, or dissolve a concentrate possibly present in the Type A chamber by this fluid, before the Type B chamber (s) are opened. and the concentrate found there enters the type A chamber in dissolved or semi-dissolved or undissolved form. The rupture of the separation devices of the type chambers

B which occur in the form of inner bags in the multi-chamber bag take place by tearing a tear seam present in the wall of the additional inner bags. In other words, the inner bags that form the Type B chambers have / have a tear seam which is preferably in the form of a perforation. By introducing fluid into type B chambers, a pressure acts on the tear seam causing it to tear, and the concentrates present in the type chambers

B, together with the fluid, enter the resulting bag and thus form a solution with the concentrates.

Preferably, the tear seams of the inner bag / pouches are called peel seams. Some are preferably produced by heat treatment and the joining of two opposite film sections. Peel seams have the advantage that they are generally soluble without a break in the film.

Preferably, the walls of the inner bag / bags have, in the region of the peel seam, a peel seam strength in the range of 0.2 to 15 N / 15mm, particularly and preferably in the range of 0.3 to 11 N / 15mm, preferably extremely in the range of 0.5 to 8 N / 15 mm. By peel seam strength is meant the tensile force at the time of tearing the peel seam. Peel seam strength can be determined by known methods ASTM D 1876-01, ASTM

F88-07 or based on EN ISO 527-3. For this in the present application, the force with which a 15mm wide strip of film is torn along the peel seam was measured in Newtons. The film strip here is a T-shaped test strip. The peel seam is located here along the width of the strip.

In the event that the multiple chamber bag of the methods of the present invention, particularly that of the second method, contains two type B chambers, it is preferred that a first type B chamber contains a concentrate that does not contribute to the electrical conductivity of the fluid. when it dissolves in it. A deviation of 1 mS / cm, preferably 0.1 mS / cm, provided by a concentrate in a ready-to-prepare solution is not seen as appropriate for a conductivity check during the manufacture of the solution. The second type B chamber contains a concentrate that contributes to the electrical conductivity of the fluid when it dissolves in it. In this case, the resistance of the seam to the detachment of the tear seam (detachment) of the separation device of the first type B chamber is equal to or less, preferably less than the resistance of the seam to the detachment of the tear seam ( detachment) of the separation device of the second type B chamber. This is also true for additional Type B chambers comprising concentrates that contribute to the electrical conductivity of the fluid when dissolved in it. It is particularly preferred, however, that additional type B chambers be opened after the first and second type B chambers.

The fact that the seam resistance to detachment of the first type B chamber is almost as high as the seam resistance to detachment of the other type B chamber has the advantage that the release of the (first) concentrate does not contribute electrical conductivity can be measured indirectly by changing the conductivity when the concentrate (second) is released which contributes to the conductivity, since due to the equal or less resistance of the seam to detachment, the first concentrate is then released into the fluid when the second concentrate is released into the fluid.

In this way it can be ensured that the first concentrate 5 always dissolves in the fluid before or at the same time that other concentrates are dissolved in the fluid.

To achieve a fast filling rate accompanied by the dissolution of all concentrates, it is advantageous if the bag is conically or V-shaped towards its lower end. Preferably, the cone has an angle in the range of 30 ° to 75 °, particularly preferably

45 ° to 65 °, most preferably 55 ° to 65 °. Fluid is introduced into type A chamber or type B chambers through (a) feed openings located at the top end of the bag. It is advantageous for the purpose of the best dissolution of the concentrates in the type chamber

A if a pipe runs from the feed opening in the top area of ​​the bag to the bottom of the bag, with the result that fluid in the Type A chamber enters the bag at the bottom. This is also true for the type B chamber feed openings that are present in the main bag in the form of internal bags. To improve the dissolution of the concentrates, a spray nozzle is preferably connected to the lower end of the pipe, where the fluid emerges into the Type A chamber. In addition, the pipe that guides through the feed opening into the camera type

A or type B chambers is preferably connected to the feed opening in such a way that only the connection of the outside of the bag is made through the pipe.

A further embodiment of the present invention by which the aforementioned object is achieved relates to a multiple chamber bag (bag) preferably containing a type A chamber and at least one type B chamber, where the chambers are separated by a device. separation, where at least sections of the separation device have a predetermined breaking point 15. By a predetermined break point is literally meant a point that breaks as a result of the application of a force and thus represents a break in the wall. In the present invention, by predetermined breaking point is meant in particular a part of the separating device or a whole of the separating device in which, through exposure or a force within the chamber, causes the spaces of the chambers come into contact with each other through the rupture of the separating device or a part of the separating device (predetermined breaking point). Most particularly, by a predetermined breaking point according to the invention is meant an area within the bag representing a part of a whole of the separating device. The predetermined breaking point is preferably formed by a peel seam. The peel seam preferably has a peel seam strength in the range of 0.2 to 15 N / 15mm, particularly preferably in the 10 range of 0.3 to 11 N / 15mm, extremely preferably in the range of 0.5 to 8 N / 15mm. The peel seam strength is measured using the aforementioned methods.

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<td>invention may also be modalities</td><td>preferred</td><td>of</td><td>the</td>

multiple chamber bag according to the invention.

In a further embodiment, the bag according to the invention is preferably a bag comprising a type A chamber, at least one type B chamber and at least two different concentrates in powder and / or liquid form. The definition, cited above with the methods according to the invention, of the concentrate also applies to the concentrates mentioned here.

In the mode in which the concentrates are already present in the bag, one of the concentrates is present in type A chamber and the other in a type B chamber, or two concentrates are present in type B chambers. The respective chambers are separated one from other separation devices. At least sections of this (or these) separation devices have a predetermined breaking point. This default breakpoint is as just defined above.

A further embodiment of the present invention is a multiple chamber bag comprising a type A chamber, a first type B chamber and a second type B chamber, where the first type B chamber comprises a first concentrate which is not capable of contributing to the electrical conductivity of a fluid where the concentrate dissolves and the second type B chamber comprises a second concentrate which is not capable of contributing to the electrical conductivity of a fluid where the concentrate is dissolved. The three chambers are preferably separated from each other in a way as mentioned above. Particularly then it is preferred that the resistance of the breakout seam of the predetermined breaking point of the separation device of the first chamber type B is equal to, or preferably less than the resistance of the breakout seam of the breakdown seam of the breaking point default of the second type B separation device. This is advantageous from the point of view of dissolving the first concentrate in a fluid introduced into the bag without degradation or agglomeration. If the multi-chamber bag contains additional type B chambers, the resistance of the peel seam peel seam to the predetermined breaking point of the separation device of the first type B chamber is preferably less than the peel seam strength. of the detachment seam from the predetermined breaking point of the separation device of additional type B chambers.

The bags mentioned are preferably bags made of film. Preferably, the bags according to the invention are made of a film consisting of one piece. In other words, the film that defines the external dimensions of the bag is made from one piece of film. The bag according to the invention or the bag used in the aforementioned method is preferably sterile inside. The state of the materials and objects achieved by a method by which the materials and articles are released from living microorganisms is termed as sterile. In practice, however, complete sterilization is not one hundred percent true. Therefore, by sterilization or the term sterile is meant a reduction in the number of microorganisms capable of multiplying by a certain factor according to the field of use. Among others, it is understood that the residual level of microorganisms capable of multiplying in one unit of sterilization product is a maximum of 10⁶Colony forming units, that is, a maximum of one microorganism capable of multiplying can be contained in one million units of sterilization product treated identically. Sterilization can be carried out by physical (thermal, and radiation) or chemical methods.

In a further embodiment of the present invention, the bag according to the invention consists of a single-layer or multi-layer film. The innermost layer of the single layer film or the multilayer film is preferably a welded film layer. The separating device preferably comprises a tear seam which is formed by welding two opposing innermost film layers. In this connection, a tear seam is understood to mean a tear seam as defined above in connection with the method according to the invention. The tear seam is preferably a peel seam.

In an alternative embodiment, the separating device is formed by forming in the bag one or more additional internal bags within type A chamber which represent type B chambers. In this embodiment, the Type A chamber may contain a feed opening for the fluid, but the internal bag or bags within the Type A chamber that form or form the Type B chambers may also have feed openings through which the they introduce the fluid inside the type B chambers.

By introducing the fluid, a pressure acts on the wall of the bag of the type B chambers which preferably have a tear seam which is defined as indicated above. Through this pressure, the device or devices for separating the wall or walls of the inner bag are / are broken, with the result that the contents of the type B chambers enter the type A chamber, with the result that all dissolved or partially dissolved concentrates from type B chambers enter the type A chamber and are mixed.

The volume capacity of the bags after the separating device or devices have / have been broken is from 30 to 100 liters, preferably from 40 to 90 liters, particularly preferable from 50 to 80 liters and extremely preferable from 55 to 70 liters .

As already mentioned above, the bag can contain a concentrate in powder and / or liquid form in at least two chambers in each case.

In a further embodiment of the present invention, the bag comprises a type A chamber and two type B chambers where each of the chambers contains in each case a concentrate in powder and / or liquid form. These concentrates are preferably of a different composition, where what was said above in connection with the method also applies to these concentrates and compositions.

In a further embodiment of the present invention, the bag according to the invention preferably comprises one type A chamber and three type B chambers, where the three type B chambers each contain a concentrate in powder and / or liquid form.

If the bag contains one type A chamber and two type B chambers, then there may be a concentrate, as defined above, with an acidic constituent in one of the type B chambers and a concentrate with a basic regulatory constituent in an additional type B chamber. . In this case, glucose can be mixed with one or both concentrates. However, for the purpose of preventing the breakdown of glucose, it is advantageous according to the invention to store the glucose in the form of an additional concentrate in a separate chamber. In this case, in the three-chamber bag modality with one type A chamber and two type B chambers, the concentrate with the basic regulating component is present in the type A chamber, and the concentrate with the acid component is present in a of the type B chambers and the glucose concentrate in the other of the two type B chambers. In the case of the bag with more than a total of three chambers, namely a bag comprising a type A chamber and three or more type B chambers, the three different concentrates are preferably present in the type B chambers.

In the aforementioned embodiments of the bag, it is preferred that the first concentrate be dissolved first of all by the fluid or be dissolved at the same time as the concentrate with the acid component. If the bag contains a total of three type B chambers in which the first concentrate, the concentrate with the acid component and the concentrate with the basic or regulating component are located respectively, it is advantageous then to arrange the chambers in such a way that the first concentrate dissolves first of all in the solvent, the concentrate with the acid component at the same time or second and the concentrate with the last basic component. This has the advantage that the pH remains stable in the aforementioned preferred range, and at least C0 is formed.₂ than otherwise.

In an alternative embodiment, a concentrate with the acid component is dissolved before the concentrate with the basic component. C0 gas release₂ it has to be considered and measures have to be taken into account to compensate for the pressures of C0₂. Sequential dissolution in the order listed is also advantageous in order to ensure a homogeneous dissolution process. If dry concentrates are used, the components of the smaller concentrate dissolve more quickly and the risk of clumping is less. The sequential dissolution of the components of the concentrate is achieved by opening the individual chambers in sequence. The sequential opening of the chambers (preferably type B) can be achieved by direct actuation of the chambers with internal filling pressures (swelling pressure). In the case where the multi-chamber bag chambers are formed by welding on opposite inner film sides of the bag, the bag is filled from below through the feed line of the type A chamber. In one embodiment, in which there are more type B chambers, the lowermost chamber is opened first by obeying the pouring of the solvent into the type A chamber - obeying the filling pressure (swelling pressure) on the release seam . The chronological order of the release / break opening of the release seam can be controlled through the corresponding arrangement of the chambers. This can ensure the sequential addition of concentrate to the resulting chambers through the opening of the release seam. Thus chambers 2, 3, 4 or 5 (type B) can be arranged outside one another, with tear openings in succession. The softening process is thus more easily controlled through the design of the bag.

In the first method of the present invention it may also be preferred that the first concentrate be dissolved before all by the fluid or be dissolved at the same time as the concentrate with the acid component. If the bag contains a total of three type B chambers in which the first concentrate, the concentrate with the acid component and the concentrate with the basic or regulating component are located respectively, it is advantageous then to arrange the chambers in such a way that the first concentrate it is dissolved first of all in the solvent, and the concentrate with the acid component at the same time or second and the concentrate with the last basic component.

In the mentioned modalities, the volume of the type A chamber can be a multiple of the volumes of the type B chambers. After the process of filling the multi-chamber bag with the fluid has been completed, the resulting chamber after the The breakdown of the separation devices comprises a volume that substantially corresponds to the volumes of all the chambers of the multiple chamber bag, namely that of the type A chamber and the type B chambers. The volume of the type A chamber of the multi-chamber bag preferably comprises a large part of this resulting chamber in which the suspension solution is located after the separation of the separation devices. In this case, the Type A chamber preferably has a volume that is 1 to 20 times (preferably 2 to 18 times, particularly preferably 3 to 15 times, even more preferably 4 to 12 times, most preferably 5 to 10 times) greater than the sum of the volumes of type B chambers.

In all the mentioned modalities, the size of type B chambers is preferably determined by the volume of the concentrates contained in them, but it can also be 1 to 4 times larger (preferably 2 to 3 times larger) than the volume that the concentrate requires. In a very general way, it should also be noted at this time that, when the type B chamber or chambers are / are being filled with fluid, the softening process is already partially taking place in the type B chambers, without the separation device being is broken. This pre-softening process can be used through proper selection of the hypothetical void volume of type B chambers compared to the volume of the concentrate. The higher the volume of the chamber compared to the volume of the concentrate, the better the performance of the pre-softening process can be (given a constant tear resistance of the separation devices).

In an alternative embodiment, however, the volume of type A chamber may not only be a multiple of the sum of the volumes of type B chambers, but it may be exactly as large or smaller than the volume of one of the type chambers. B. In this case the dimension of the type A chamber preferably does not differ substantially from those of the type B chamber. One chamber is connected to the next (type A chamber and type B chamber) through separation devices. The type A camera can lie close to one or more type B cameras, but also between two or more type B cameras. In this way, the type A camera is indistinguishable from the type B cameras. Through simultaneous rupture or. successive of the separation devices during filling with fluid, a resulting chamber is formed, the volume of which substantially comprises the sum of the volumes of all the chambers of the multi-chamber bag.

In the case of a bag comprising more than two chambers, the contents of the first chamber, together with the fluid, are preferably introduced into the second chamber, lying below it, during the successive rupture of the separation devices. Subsequent rupture of the second separating device then leads to the combined contents of the first and second chambers being introduced into the third chamber preferably lying below it, and so on (as appropriate). Preferably, the fluid is poured with a previously mentioned feeding device into the type A chamber, which is then the first chamber in the aforementioned embodiment, which is preferably arranged higher than the type B chambers. In this case, the Type A camera can be distinguished from Type B cameras in particular by this feature.

In the case where the type B chambers are formed by internal bags in the bag type A chamber, the disposition of the internal bags is of less importance, since the tear seams do not open as a result of the filling of the type chamber A with fluid, but is opened by filling the respective chamber B with fluid. As a result of filling, a filling pressure (swelling pressure) acts on the release seam of the inner bag forming the Type B chamber. If the fill pressure reaches a certain level, the release seams open and the mixture / respective concentrate-fluid solution enters chamber type A. With regard to the arrangement of several type B cameras, it should only be borne in mind that the contents of a chamber arranged above are not poured into an internal bag of an additional type B camera. In this way, incomplete dissolution of the corresponding concentrate is avoided. The sequential opening of type B chambers in the aforementioned order is ensured either by peel seams having different peel seam strengths with corresponding gradation with the same rate of filling type B chambers with fluid, or by the part of the fluid that is being introduced into type B chambers in sequence with the same peel-off resistance. All of the features cited with respect to the multi-chamber bag according to the invention are also features that the multi-chamber bag may have in the aforementioned method according to the invention.

Furthermore, it is advantageous with respect to the dissolution rate or dissolution behavior of the concentrates in the bag that the bag tapers conically or in a V-shape towards its underside. The conical or V-shaped end of the bag is located on the opposite side of the bag feed opening. Cone 5 preferably has an angle in the range of 30⁰ degrees to ° particularly preferably 45 ° to 65 °, most preferably 55 ° to 65 °. Furthermore, it is advantageous if a pipe is passed through the feed opening towards the bottom of the bag, with the result that the fluid to be introduced enters the bag in the type A chamber at the bottom. The pipe is normally connected to the feed opening in such a way that only the opening on the outside of the bag is made through the inside of the pipe. The pipe is preferably a plastic pipe.

If one of the above-mentioned bags according to the invention is used in hemodialysis or peritoneal dialysis, then the resulting chamber after the rupture of the separation devices, the volume of which substantially comprises the sum of the volumes of all the chambers, represents preferably a space to keep the dialysis fluid cool. Through the mentioned feeding opening, which can also serve as an outlet opening for the freshly prepared dialysis fluid, it can be used in a hemodialysis or peritoneal dialysis device. The used dialysate can be collected in such a dialysis device either in a separate container or in a container surrounding the bag according to the invention. It is preferred that such a container surrounding the bag according to the invention is likewise a bag made of film surrounding the entire exterior of the bag according to the invention. A dialysate feed opening used in the surrounding bag preferably leads through a tube through the bag inlet or outlet opening according to the invention all the way through type A chamber and terminates in a bag surrounding the bag according to the invention which is used to collect the used dialysis fluid. Preferably, the bag surrounding the bag according to the invention, which is to collect the used dialysis fluid, is made of the same material as the bag according to the invention.

A further embodiment of the present invention relates to the use of a bag according to the invention in hemodialysis or peritoneal dialysis, in particular as a container for keeping the dialysis fluid in a hemodialysis or peritoneal dialysis device.

The bag used in the process according to the invention or the bag according to the invention or the internal bags preferably consist of a multilayer film. The multilayer film preferably has a tear elongation in the film extrusion longitudinal direction of 250% to 850%, preferably 400% to 800%, more preferably 500% to 750%, and most preferably 600% to 700% , and in the cross-extrusion direction of the film from 300% to 1050%, preferably from 450% to 1000%, more preferably from 600% to 900% and most preferably from 700% to 800%.

By elongation at tear or elongation at break is meant the ratio of the percentage of the change in length AL (at break) to the starting length. It expresses the ability of a material to follow changes in shape without breaking. The elongation at break is measured in the tensile test according to DIN 53455.

A great ability of the film to change its length in the longitudinal direction of the film extrusion in the aforementioned range has the advantage according to the invention that while it is being filled with or emptied of dialysate (fresh used) the bag undergoes a change in volume without forming fractures before the given upper limits.

This brings with it the additional advantage that when only a small quantity of material is required to be emptied, there is nevertheless a large volume capacity with filling. A product can therefore be provided with a product that carries only a small amount of waste. This is particularly advantageous from an environmental point of view.

By multilayer film is meant in the present invention a film consisting of two or more layers of the same or different material that are bonded together. It is preferred within the framework of the present invention that the multilayer film is made up of from 2 to 10 layers, where a 2-5 layer structure is more preferred and a 3-4 layer structure is particularly preferred. The multilayer film can be produced according to any process that is known to a person skilled in the art as being suitable for the purposes according to the invention.

Additionally, the multilayer film preferably has a tear strength in the longitudinal direction of 300 N / mm² up to 350 N / mm², preferably 310

N / mm² up to 340 N / mm² and more preferably 320 N / mm² up to 330 N / mm², and in the transverse direction of the extrusion of the film of 220 N / mm² up to 270 N / mm², preferably 230 N / mm² up to 260 N / mm² and more preferably 240 N / mm² at 250 kp / cm².

Tear strength is the tensile stress that is exerted on an article at the time of

<td>tear. The</td><td colspan="2">tear strength</td><td>measures in</td><td>the proof</td><td>of</td>

<td>tear of</td><td>according to DIN</td><td> 53455.</td><td colspan="2">A resistance</td><td>to the</td>

<td>5 tear by</td><td>below the limit</td><td>lower</td><td>before</td><td>mentioned</td><td>is</td>

<td>disadvantageous,</td><td>since the</td><td>of other</td><td>shape</td><td>the bag</td><td>I know</td>

rips prematurely during overextension. Although the bag is very tear resistant above the above quoted value, it is not sufficiently understandable.

Furthermore, the multilayer film preferably has a transverse extension ratio μ in the rubber elastic state of 0.45 to 0.55, more preferably

0.47 to 0.53 and most preferably 0.49 to 0.51.

The transverse extension ratio, also called the Poisson ratio, is defined as the ratio of relative change in thickness Ad / d with respect to the relative change in length Δ1 / 1 due to exposure to an external force or stress.

Furthermore, the multilayer film can be stretched up to 500% by a force of preferably 45N up to

N, more preferably 48N to 62N, most preferably 52N to 58N. To measure extensibility, a weight corresponding to a specific force in N is uniformly applied to a film 15 mm wide and the change in length.

High extensibility has the advantage that the bag is small when it is not full and therefore easy to handle. Furthermore, the material requirement is small as a result of the strong extensibility of the material.

This also makes simpler manufacturing and packaging of the material possible.

In the case of the bag according to the invention, the ratio of the external surface of the bag when full to the maximum of the external surface when not full is preferably in the range of preferably y 2: 2/1, plus preferably 5/1. Typical upper limits are approximately 8/1 to 12/1, for example 10/1 or 9/1. However, higher ratios are also provided in accordance with the invention.

By external surface is meant the surface of the bag that comes into contact with its surroundings (air) when it is full and also when it is not full. The term when filled to the maximum is described by the maximum size of the bag in which the bag does not yet rupture and consequently does not tear yet.

By when it is not full is meant the state of the bag in which the inside of the bag is essentially not filled by material of any kind, that is, it essentially does not take up space.

The property in the increase in the surface in relation to the filling quantity ensures that the multilayer film of the bag is always under pressure during filling, with the result that as it is increased in filling this pressure increases. increases and any grooves in the multilayer film that may be present when the non-fill increasingly disappears. This has the advantage according to the invention that a groove-free introduction of the bag into a reservoir in a medical device, in particular a dialysis machine, is ensured. Thus complete removal of fluid from the bag is also ensured.

In a further embodiment of the present invention, the ratio of the volume capacity of the bag according to the invention when filled to the maximum volume capacity in the state in which the multilayer film is extended is preferably at 3/1, preferably 5/1. Typical non-limiting ranges are 3/1 to

12/1, more preferably 5/1 to 11/1, even more preferably from 7/1 to 10/1 and most preferably from 8/1 to 9/1. Other higher upper limits are however also possible according to the invention.

By volume capacity in the state in which the multilayer film is not extended is meant the volume that can be poured into the bag without an extension of the multilayer film.

The aforementioned properties of the film (preferably of a multilayer film) are preferably achieved by a three or more layer film, preferably three layers. Both outer layers of the film must be chosen from a material that prevents damage to these layers - for example due to film manipulation - generating unwanted predetermined breaking points, leading to bag tear when the bag formed to From this film it is subsequently filled and when the bag undergoes extreme extension.

Accordingly, both the outer layers of the film, unlike the inner layers, are preferably more robust against mechanical influences . Additionally, the film should preferably not tend to adhere during storage of a multi-chamber bag according to the invention and to heat sterilization. Opposite to this is the requirement to produce peel seams with a corresponding welding tool preferably at relatively low temperatures. Peel seams are characterized in that they are produced by welding or partial adhesion of the films by treatment with heat and contact pressure. Preferably, therefore, the temperature for the formation of the release seams falls below the welding temperature for permanent welded seams. A film that is used in accordance with the invention should preferably have high elastic extensibility without high exposure to force. However, such films tend in most cases to already form unwanted adhesion connections without a pressing effect of the welding tools corresponding to a common heat sterilization temperature of 100 to 120 ° C, for 5 to minutes. (approximately 10 minutes) at a pressure between

1.5 and 2.5 bar (approximately 2 bar). A film for a pouch according to the invention is therefore preferably a compromise between technically opposing requirements of heat sterilizability, mechanical robustness, elastic extensibility, producibility of permanent and detachable bond seams and good sectioning of the films afterwards. of heat treatment. Regarding the elastic extensibility of the films and of the bags produced therefrom, a homogeneous extension is required due to force exposure or bag filling. If the bag is spread non-homogeneously, there is a risk of individual areas being overextended while other areas are not, or are less spread.

That is, the multi-chamber bag according to the invention or the multi-chamber bag of the methods according to the invention is preferably a bag made from a film, where the film is an extensible elastic film which extends preferably when the fluid is introduced into one of the chambers. The bag spreads in a balloon-like shape when filled with a diluent and contracts when fluid is withdrawn from the bag. The bag that is manufactured from a film that exhibits elastic tensile behavior and therefore plastic tensile characteristics is preferably removed.

Example film structures are:

Type 1 film: inner layer: layer thickness: 10 pm,

100 parts of hydrogenated styrene block copolymer of styrene, ethylene, butylene or propylene, eg SEBS

Septon 2005, Kuraray, 70 parts polypropylene randomized with ethylene as comonomer PP23M10cs264 Rexene, Huntsmen.

Intermediate layer: layer thickness: 100 pm, 30% Tuftec 1221, Asahi, 70% analogous to the composition of the inner layer.

Outer layer: analogous to the inner layer.

Type 2 film: inner layer: layer thickness: 10 pm, 60% random polypropylene Bormed SC 220 Borealis, styrene, ethylene, butylene or propylene hydrogenated styrene block copolymer, eg 40% Septon

8004, Kuraray.

Middle layer: 100 pm, 30% Tuftec H 1221, Asahi

Outer layer: analogous to the inner layer.

Type 3 film: inner layer: layer thickness: 10 pm,

100 parts of styrene block copolymer of styrene, ethylene, butylene or propylene, eg Septon 2005,

Kuraray, 70 parts polypropylene randomized with ethylene as comonomer PP23M10cs264 Rexene

Intermediate layer: layer thickness: 100 pm, 40% Engage,

Dow Chemical, 25% Tuftec 1062, 35% Septon 8004,

Kuraray.

Outer layer: analogous to the inner layer.

Figure 1 shows a section through a bag (1) with a type A chamber (2) and two type B chambers (3, 3a), where the separation device (4) is present in the form of a seam of tear (10). There is a concentrate (5) which is preferably a basic concentrate or regulator in chamber type A (1). A pipe or tube (9) leads from the supply opening (8) into the type A chamber (2) and ends in the lower V-shaped area of ​​this chamber. At the end of the tube, there is a spray nozzle (6) through which the fluid enters the chamber. The weld seam (7) represents an internal weld of the inner surface of the bag film which can be a tear seam within the meaning of the invention or represents a weld seam which does not have a predetermined breaking point . The chamber type A (2) preferably contains a concentrate (5) with a basic regulating component, where the chambers type B (3, 3a) preferably contain the concentrate with glucose or the concentrate with the acid component (5).

Figure 2 shows a section through a bag (1) with a type A chamber (2) and two type B chambers (3,

3a), where the separating device (4a) or type B chambers (4a) are present in the form of an internal bag within the type A chamber, where this bag has a predetermined breaking point in the form of a seam tear (10a). Type A chamber (2) and type cameras

B (3, 3a) have a feed opening (8). A fluid can be introduced into the chambers through this feed opening. The feed openings (8) are preferably present in the form of a pipe or tube (9) that extends into the concentrate (5) to the bottom of the chambers. A spray nozzle (6) which makes possible a better dissolution of the concentrate in the type A chamber (2) is preferably connected to the lower end of the pipe (9) of the type A chamber (2). The chamber type A (2) is preferably present in the form of a V which is sharpened downwards, with the result that, in comparison with a square bag, a better dissolution behavior of the concentrates in the chamber is made possible type A. The V-shape of the Type A chamber (2) is achieved by producing a V-shaped weld seam (7) through opposite inner sides of the bag. The weld seam can be a tear seam within the meaning of the invention, with the result that, from a certain pressure which is produced by the pouring of a certain amount of fluid, separates and

<td>provides a</td><td>greater space</td><td>in</td><td>the shape</td><td>of a</td><td>bag</td>

<td>square. The</td><td>concentrate (5)</td><td>in</td><td colspan="2">camera type</td><td>A is</td>

<td>preferably</td><td>a concentrate</td><td colspan="2">basic or</td><td>regulator.</td><td>The</td>

<td colspan="3">concentrates (5) in the chambers</td><td>type B</td><td>(3, 3a)</td><td>are</td>

<td>preferably</td><td>a concentrate</td><td>than</td><td>contains</td><td>glucose,</td><td>or the</td>

concentrate containing the acid component.

Figure 3 shows a section through a bag (1) that has a type A chamber (2) and four type B chambers (3, 3a, 3b, 3c), where the separation device to the separation devices (4 ) is / are present in the form of a tear seam (10). When the camera type

A (2) is being filled with fluid through the pipe or tube (9) through the feed opening (8), a force acts on the tear seams (10), with the result that you are The concentrates (5) of the lower type B chambers (3, 3a) are initially opened and dissolved first in the fluid introduced into the type A chamber (2) and the concentrates (5) of the type B chambers (3b,

3c) dissolve second in the fluid as a result of the tear opening of the tear seam (10) of these chambers. The pipe of the tube (9) that leads to the type A chamber (2) has, at the lower end of the V-shaped area of ​​the bag, a spray nozzle (6), which ensures the best dissolution of the concentrates (5) in the fluid. Also, this bag (1) preferably has, in the lower area, a tapered or V-shaped pointed end 20 which is achieved by welding the inner opposite sides of the bag by means of a weld seam (7). This weld seam can be a tear seam within the meaning of the invention, which separates under a corresponding pressure that acts as a result of the shedding of the fluid, with the result that a square bag is formed, or a weld seam solid, whereby the V-shape of the bag is preserved during the dissolution of the concentrates.

The type B chambers (3, 3a) preferably contain the basic or regulating concentrate (5), while one of the type B chambers (3b, 3c) contains the glucose concentrate (5) or the concentrate (5) with the component acid.

Figure 4 shows a section through a bag (1) that has a type A chamber (2) and three type B chambers (3, 3a, 3b), where the separation devices (4a) or the type chambers ( 3, 3a, 3b) are present in the form of inner bags having a tear seam (10a) as the predetermined breaking point. Each of the type B chambers (3, 3a, 3b) and the type A chamber (2) have a supply opening (8) that makes it possible to introduce a fluid into the respective chambers through a pipe or tube ( 9). The tube or pipe (9) preferably extends into type B chambers (3, 3a, 3b) into the chambers so that the fluid emerges in half of the concentrates (5). The tube or pipe (9) of the type A chamber (2) leads to the bottom of the V-shaped pointed bag and preferably has a spray nozzle (6) for the best dissolution of the concentrates that enter the camera type A. Type B chambers (3, 3a, 3b) each have a tear seam (10a) as a predetermined breaking point, which rupture at a certain pressure exerted as a result of fluid introduction, with the result that concentrates (5) of the type B chambers (3, 3a, 3b) enter the type A chamber (2) together. The bag (1) that surrounds the internal bags or type B chambers (3, 3a, 3b), which essentially form the type A chamber (2) have a V shape at the lower end. The V-shape is achieved by welding two opposite inner sides of the bag using a weld seam (7).

The weld seam can be a weld seam within the meaning of the invention, which breaks with a certain pressure caused by the introduction of the fluid, with the result that a rectangular bag is formed, or it can be a weld seam fixed by which the V-shape of the bag is preserved. The type B chamber (3a) preferably contains the concentrate with the acidic or regulatory component. Accordingly, type B chambers (3, 3b) preferably contain the concentrate with the glucose component and the concentrate with the acid component.

Figure 5 shows a bag (1) with a type A chamber (2) and three type B chambers (3, 3a, 3b) where the type chambers

Β (3, 3a, 3b) are present separated from the type A chamber (2) by a separating device (4) in the form of a tear seam. The tear seam is formed by welding the two opposite inner sides of the bag (1) together in such a way that the tear seam separates as a result of the pressure caused by the pouring of the fluid and the concentrates are combined in type A chamber (2) . A pipe or tube (9) through which the fluid can enter the type A chamber (2) through a supply opening (8) extends into the chamber A (2). A spray nozzle (6) is preferably located at the lower end of the pipe or tube (9) for the best dissolution of the concentrates in the fluid. The bag preferably tapers into a V shape at the bottom end of the chamber type

A (2), which is secured by a weld seam (7). The weld seam (7) can be a tear seam within the meaning of the invention which breaks as a result of pressure caused by filling with the fluid, with the result that it forms a rectangular pouch or it can be a seam Fixed weld seam which ensures the V-shape of the bag even when filled with fluid. The concentrate (5) in the type B chamber (3) is preferably a concentrate with a basic or regulating component. The concentrate (5) in the type B chamber (3a) is preferably a glucose-containing concentrate. The concentrate (5) in the type B chamber (3b) is preferably a concentrate with an acid component. As with the arrangements in Figures 1 to 4, such an arrangement ensures that the pH remains stable in the preferred range during mixing of the different concentrates in type A chamber in the preferred range according to the invention.

Figure 6 shows a section through a bag (1) that has a type A chamber (2) and four type B chambers (3, 3a, 3b, 3c), where the separation devices (4, 4a,

4b, 4c) are present in the form of a tear rib (10). When the type A chamber (2) is being filled with fluid through the pipe or tube (9) through the supply opening (8), a force acts on the tear seams (10), with the result that these are opened and first the concentrates (5, 5a) of the lower type B chambers (3, 3a) are first dissolved in the fluid introduced into a type A chamber (2) and the concentrates (5b, 5c) of the type chambers B (3b, 3c) dissolve second in the fluid as a result of tear opening of the tear seam (10) of these chambers. The pipe or tube (9) that leads to the type A chamber (2) has, at the lower end of the V-shaped area of ​​the bag, a spray nozzle (6) which ensures a better dissolution of the concentrates ( 5, 5a,

5b, 5c) in the fluid. Also, this bag (1) preferably has, in the lower area, a tapered or V-shaped pointed end which is achieved by welding the inner opposite sides of the bag by means of a weld seam (7). This weld seam can be a tear seam within the meaning of the invention, which opens under corresponding pressure acting as a result of fluid shedding, with the result that a square pocket is formed, or a solid weld seam , through which the way in which

V of the bag during the dissolution of the concentrates. The type B chamber (3) preferably contains a concentrate (5) that does not contribute to the electrical conductivity of the resulting fluid. Type B chamber (3a) preferably contains a concentrate of the acid component (5a). Type B chambers (3b, 3c) preferably contain both basic component concentrates (5b, 5c). The bag additionally contains a container surrounding the bag according to the invention.

It is preferred that such a container surrounding the bag according to the invention is likewise a film bag surrounding the entire exterior of the bag according to the invention. A feed opening (8a) for the dialysis fluid used in the surrounding bag preferably leads through a tube (9a) through the inlet or outlet opening of the bag according to the invention directly through the chamber type A and ends 5 in the bag surrounding the bag according to the invention which is to collect the used dialysis fluid.

Preferably, the bag surrounding the bag according to the invention, which is intended to collect the used dialysis fluid, is made of the same material as the bag according to the invention. Type B chambers (3, 3a, 3b,

3c) are formed by a tear seam which is completely formed by welding the opposite inner sides of the bag.

Figure 7 shows a section through a bag (1) 15 which has a type A chamber (2) and four type B chambers (3, 3a, 3b, 3c), where the separation devices (4,

4a, 4b, 4c) are present in the form of a tear seam (10). When the type A chamber (2) is being filled with fluid through the pipe or tube (9) through the feed opening (8), a force acts on the tear seams (10), with the result of that the concentrates (5, 5a) of the lower type B chambers (3, 3a) are first opened and are dissolved first in the fluid introduced into the type A chamber (2) and the concentrates (5b, 5c) of the type chambers B (3b, 3c) dissolve second in the fluid as a result of tear opening of the tear seam (10) of these chambers. The pipe or tube (9) leading to the type A chamber (2) has, at the lower end of the V-shaped area of ​​the bag, a spray nozzle (6) that ensures the best dissolution of the concentrates ( 5, 5a, 5b, 5c) in the fluid. Also, this bag (1) preferably has, in the lower area, a V-shaped conical taper which is achieved by welding the opposite inner sides of the bag by means of a weld seam (7). This weld seam can be a tear seam within the meaning of the invention, which separates under a corresponding pressure that acts as a result of the shedding of the fluid, with the result that a square bag is formed, or a weld seam solid, where the V-shape of the bag is preserved during the dissolution of the concentrates. The type B chamber (3) preferably contains a concentrate (5) that does not contribute to the electrical conductivity of the resulting fluid. Type B chamber (3a) preferably contains a concentrate of the acid component (5a). Type B chambers (3b, 3c) preferably contain both basic component concentrates (5b, 5c). The bag additionally contains a container surrounding the bag according to the invention. It is preferred that such a container surrounding the bag according to the invention is likewise a film bag surrounding the entire exterior of the bag according to the invention. A feed opening (8a) for the used dialysis fluid into the surrounding bag preferably leads through a tube (9a) through the inlet or outlet opening of the bag according to the invention directly into the chamber type A and ends in the bag surrounding the bag according to the invention which is intended to collect the used dialysis fluid.

Preferably, the bag surrounding the bag according to the invention, which is intended to collect the used dialysis fluid, is made of the same material as the bag according to the invention. Type B chambers (3, 3a, 3b,

3c) are formed by a tear seam which is partially formed by welding the opposite inner sides of the bag.

Ex emplos

Example 1: Preparation of a multi-chamber bag with granular material:

A multilayer film of the aforementioned type of film i with the external dimensions of 45 cm x 66 cm is folded in half on its width side, with the result that two sides of the film are opposite each other and form a two-layer film with rectangular cross sections (giving a bag size of 45 cm x 33 cm), which are joined together on their longitudinal sides. About 5 cm from the bottom edge (width side) of about 1 cm from the right edge (longitudinal side), the first half of a first granular material (see below for quantities and composition) are inserted into a first pocket forming a peel seam circular linear (Θ 12 cm) between the two inner sides of the film by thermal welding, with the result that the granular material is enclosed by the peeling seam. In the same way, the second half of the first granular material is introduced into a second pocket at a distance of approximately 1 cm from the other longitudinal side. In the same way, a second granular material (see below for amount of composition) is introduced into a third pocket at a distance of 3 cm from the first pocket release seam in the direction of the opposite width side and at a distance of about 1 cm from the longitudinal side (right side). Again 3 cm from the detachment seam of the second pocket in the direction of the opposite width side and approximately 1 cm from the longitudinal side (left side), a third material is introduced (see below i

for quantity and composition) in this fourth pocket in the same way. The two halves of the film are then welded together on the remaining three open sides, leaving one space (about 3 cm) on the width side opposite the first pocket in the center of the edge and one additional space on the width side opposite this edge width side, in which case the two film halves are not welded together in each case. A first plastic tube approximately 40 cm long that has a spray nozzle at the inner end and that ends inside the bag is passed into the bag through this space. A second plastic tube approximately 4-8 cm in length is passed through the interior of the bag through both spaces, with the result that it protrudes from the spaces on both sides of width. The tubes and films of the bag are then welded together at the point where the plastic tubes enter the bag and the second plastic tube emerges, such that the inside of the bag is even connected to the outside of the bag only through the first tube. From the center of the bottom width side of the bag, two weld seams are also joined in the shape of a

V at an angle of 60 ° to each other to the longitudinal ends by thermal welding, with the result that the inside of the bag is tapered conically and the bottom end (Figure 5 shows a bag according to Example 1). A second bag measuring 48 cm x 34 cm, which is welded in such a way that it can only be entered through the second tube, is attached around the entire bag. The interior of the second pocket is intended to serve as a collection container for recycled used dialysis fluids.

First granular material (half of each in the first and second pocket):

NaCI: 166.78 g

NaHCO₃: 190.34 g

Second granular material:

NaCI: 166.7

Glucose x H₂O: 68.20 g

Third granular material:

Salt composition: 77.38

Composition of the salt composition:

NaCI:

KC1:

46.83 wt%

11.95% by weight

CaCl₂ XH₂0:

17.67 by weight

MgCl₂X 6H₂O: 8.15% by weight

Citric acid: 15.40% by weight

Comparison Example 1:

A bag is produced substantially as in Example 1, except that none of the three pockets are formed, but the three granular materials (first to third granular material according to the example) are introduced directly into the main chamber of the bag .

Comparison Example 2:

A bag is produced as in Example 1 except that the first granular material is introduced into the third pocket and the third granular material is introduced into the first pocket.

Example 2:

A multilayer film of the type specified in Example 1 with the external dimensions of 45 cm x 66 cm is folded in half on its width side (giving a bag size of 45 cm x 33 cm) with the result that two sides of the film are opposite each other and form a two-layer film with rectangular cross sections, which are joined together on their longitudinal sides. At approximately 3 cm from the bottom edge of one of the width sides, a first granular material (see example 1 for amount of composition) is introduced into a first pocket forming a circular linear peel seam (Θ approximately 10 cm) between the two Inner sides of the film by thermal welding, with the result that the granular material is enclosed by the two opposite sides of the film and the peel seam. The center of the first pocket is approximately the same distance from both longitudinal sides; the same applies to the second and third pocket. In the same way, a second granular material (see Example 1 for quantity and composition) is introduced into a second pocket at a distance of approximately 5 cm from the first pocket release seam in the direction of the opposite width side. Again approximately 5 cm from the release seam of this second pocket in the direction of the opposite width side, a third granular material (see Example 1 for quantity and composition) is introduced into a third pocket in the same way. The two halves of the film are then welded together on the remaining three open sides, where a first space (approximately 3 cm) is left on the width side opposite the first pocket in the center of the edge, in which case the two halves of the film do not weld together. In the same way, a second space of about 2 cm is left free on the opposite width side. A first 45 cm long plastic tube that has a spray nozzle at the inner end is passed through this first space, into the bag. This end is located inside the bag. A second plastic tube is also passed through the inside of the bag but emerges in the spaces at both ends in equal parts. The tubes and films in the bag are then welded together at the points in the bag where the plastic tubes enter / emerge from the bag, such that the inside of the bag is still connected to the outside of the bag. bag only through the first feeding tube. From the center of the bottom width side of the bag, two weld seams are also joined in the shape of a V at an angle of 60 ° with respect to each other to the longitudinal sides by thermal welding, with the result that the inside of the bag tapers at the lower end (Figure 5 shows a bag according to Example 1). A second bag measuring 48 cm x 34 cm, which is welded in such a way that it can only be entered through the second tube, is attached around the entire bag. The interior of the second pocket serves as a collection container for recycled used dialysis fluid.

Example 3:

In Example 3, RO water is introduced into the bag at a rate of about 6 liters per minute through the bag feed tube produced in Example 2.

The first pocket peel seam opens first, whereupon the first granular material gradually dissolves. The release pocket seam of the second pocket is then loosened by the fill pressure caused by filling with the fluid. Once the second granular material is gradually dissolved in the RO water, the release pocket seam of the third pocket opens. The third granular material is then gradually dissolved.

After adding 6 0 liters of RO water, there is an almost clear solution whose pH is 7.3. Only minor rainfall is observed.

Comparison Example 3

In Comparison Example 3, the procedure is as in Example 3, but using the bag produced in Comparison Example 1. During filling of the bag, it is noted that the mixed granular material (first to third granular material of the example 1) dissolves only poorly.

In addition, a bubbling is observed which is identified as CO₂. At the end of the addition, there is a cloudy solution that has a pH of 8.5. The precipitate contains CaCo₃. The concentrate changes color and agglutinates. Storage stability is then not ensured. After approximately two weeks of storage at 40 ° C and 75% relative humidity, glucose and bicarbonate decompose.

Comparison Example 4:

In Comparison Example 4, the procedure is as in Example 3, but using the bag produced in Comparison Example 2. During filling of the bag, it is noted that the third and second granular material dissolves well. After the third pocket release seam is loosened, the first granular material is gradually added. Initially a bubbling begins. Bubbles are identified as CO₂. The first two thirds of the first granular material is then completely dissolved. However, if the last third of the first granular material enters the main chamber solution, it can be seen that the solution initially becomes slightly cloudy. Over time, turbidity increases. At the end of the addition, there is a strongly cloudy mixture that has a pH of 8.6. The precipitate contains CaCO₃.

In Example 3 and Comparison Examples 3 and 4, the bags produced in Example 1 and Comparison Examples 1 and 2 were filled with RO water for 2 hours after production. When Comparison Example 4 is carried out, it is notable that the dissolution time of the concentrates is much longer compared to the examples according to the invention and is therefore not acceptable for use according to the invention. .

Example 4:

The bag produced according to Example 2 was stored for 3 weeks at a temperature of 40 ° C and a humidity of 75%. No visual change in the granularity / powder quality of the three granular materials could be observed. After the addition of 60 liters of RO water, from example 3, the same result was obtained as in the example.

Comparison Example 5:

The bag produced according to Comparison Example 2 was stored in the same way for 3 weeks at a temperature of 4 0 ° C and a humidity of 7 5%.

When 6 0 L of RO water was added as in Comparison Example 3, the dissolution behavior of the mixed granular material was observed to be greatly reduced. After the addition of 60 liters of RO water, there was a cloudy solution with a large amount of undissolved concentrate.

Example 5: Production of a multi-chamber bag according to figure 6:

A multilayer film of the aforementioned film type 1 with the external dimensions of 45 cm x 66 cm is folded in half on its width side, with the result that two sides of the film oppose each other and form a two-layer film with rectangular cross sections (giving a bag size of 45 cm 33 cm), which are joined together on their longitudinal sides. In approximately the dimensions shown in Figure 6, four chambers (3, 3a, 3b, 3c) are formed by welding tear seams as shown in Figure 6, surrounding the concentrates (5, 5a, 5b, 5c) in the form granules. The two halves of the film are then welded together on the remaining three opening sides, where a space (approximately 3 cm) is left on the opposite width sides of the first pocket in the center of the edge and an additional space in the width side opposite this width side at the edge, in which case the two halves of the film are not welded together in each case. A first plastic tube about 4 0 cm long that has a spray nozzle at the inner end and ends inside the bag is passed into the bag through this space. A second approximately 4 8 cm plastic tube is passed through the inside of the bag through both spaces, with the result that it protrudes from the spaces on both sides of the width. The tubes and films in the bag are welded together at the point in the bag where the plastic tubes enter the bag and the second plastic tube emerges, such that the inside of the bag is still connected to the outside of the bag. the bag only through the first tube. From the center of the bottom width side of the bag, two weld seams are also joined in the shape of a V at an angle of 60 ° with respect to each other to the longitudinal sides by thermal welding, with the result that the inside of the bag tapers at the bottom end. A second bag measuring 48 cm x 38 cm, which is welded in such a way that it can only be entered through the second tube, is attached around the entire bag. The interior of the second pocket serves as a collection container for used recycled dialysis fluid.

Concentrate (5): glucose (anhydrous): 62 g, resulting in a concentration of: 5.55 mmol / 1;

Concentrate (5a): MgCl₂ x 6H₂O: 6.3 g, resulting concentration: 0.5 mmol / 1; CaCl₂ (anhydrous): 8.62 g, resulting in a concentration of: 1.25 mmol / 1; KC1: 9.24 g, resulting in a concentration of: 2 mmol / 1; citric acid: 11.97 g, resulting in a concentration of:

mmol / 1.

Concentrate (5b, 5c): NaCI: 3 91.2 g, resulting in a concentration of: 108 mmol / 1; NaHCO₃: 166.78 g, resulting in a concentration of 32 mmol / 1.

Example 6:

In Example 6, RO water is introduced into the bag at a rate of about 6 liters per minute through the bag feed tube produced in Example 5.

The release seam of the chambers (3) and (3a) is first opened at the same time, whereby the concentrates (5) and (5a) are gradually dissolved. Next, the chamfer seams in chambers (3b) and (3c) are loosened by the filling pressure caused by filling with fluid. The concentrates (5b) and (5c) are then gradually dissolved. After the addition of approximately 60 to 62 liters of RO water, there is a total clear solution whose pH is 7.3. No precipitation is observed.

Example 7:

During the introduction of water in Example 6, the electrical conductivity of the fluid in the bag is measured. Before the bags are opened, the measured electrical conductivity is approximately 0 mS / cm. When the second type B chamber (3a) is opened, a change in the conductivity of the introduced fluid is measured. Since the resistance of the peel seam to the peel seam of the chambers (3) and (3a) is similar, both concentrates (5) and (5a) dissolve at the same time. Since the concentrate (5a) leads to a change in conductivity and due to the release of the concentrate (5) and (5a) at the same time, it can be ensured that the glucose dissolves in the fluid.