Multi-chamber bag

lllllllllllllllllllllllllllllllllllllllllll © Publication number: 2,725,007

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SPANISH OFFICE OF

PATENTS AND TRADEMARKS

SPAIN © Int. Cl .:

A61M 1/16 A61J 1/20

A61M 1/28 (2006.01) (2006.01) (2006.01)

TRANSLATION OF EUROPEAN PATENT

T3 © Date of submission and number of the European application: 15.12.2010 E 16204788 (0) © Date and publication number of the European concession: 06.02.2019 EP 3165244 © Title: Bag of multiple cameras © Priority:

16.12.2009 DE 102009058445 © Date of publication and mention in BOPI of the patent translation:

09-18-2019 © Owner / s:

FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH (100.0%) Else-Króner-StraBe 1 61352 Bad Homburg, DE © Inventor / en:

BRANDL, MATTHIAS; LAFFAY, PHILIPPE; HERRENBAUER, MICHAEL; FICHERT, THOMAS; KUGELMANN, FRANZ and HÓRMANN, JÓRN © Agent / Representative:

CARVAJAL Y URQUIJO, Isabel

ES 2 725 007 T3

Notice: Within nine months from the date of publication in the European Patent Bulletin, of the mention of granting the European patent, any person may object to the European Patent Office to the granted patent. The opposition must be in writing and be motivated; It will only be considered as formulated once payment of the opposition fee has been made (art. 99.1 of the

Convention on the Granting of European Patents).

ES 2 725 007 T3

DESCRIPTION

Multi camera bag

The present invention relates to a multi-chamber bag. In all embodiments, at least three different concentrates may be included separately in powder form, liquid form or semi-liquid suspension 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 or a hemodialysis or peritoneal dialysis device, in particular as a container for a dialysis fluid in a hemodialysis or peritoneal dialysis device.

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, in which both flow paths are normally separated between yes for a semipermeable membrane. The first flow path is part of an extracorporeal blood circulation system with a feed line and a return line for blood and also optionally a pump that supports blood flow. The second path is connected to the equipment that feeds and withdraws the dialysis fluid.

In addition to the so-called single path systems in which the continuously fed dialysis fluid passes through the dialyzer only once and then discarded, so-called discontinuous systems are known. Document DE 31 15 665 C2 describes a hemodialysis device of this type that operates with a fixed volume vessel sealed against the atmosphere that is completely filled with new dialysis fluid before the start of treatment. During operation, the fluid is pumped out of the container through the dialyzer and the used fluid is passed back to the container.

In the case of the known hemodialysis device, the new and used dialysis fluids are prevented from mixing by removing the dialysis fluid in the upper area of ​​the container and returning it in the lower container area. The lower arrangement of the new dialysis fluid with the dialysis fluid used remains stable by maintaining a vertical temperature gradient in the container from top to bottom.

The container consists of glass that, due to the pore-free surface, is superior in terms of hygiene and bacteriology to other materials. In addition, the glass is very resistant to chemicals that can be considered, can be cleaned satisfactorily and is physiologically safe. However, a repeatedly reusable glass container of this type proves to be disadvantageous since the glass container must be disinfected before the new dialysis treatment.

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

Containers for containing medical fluids are flexible plastic bags consisting of two films that are arranged flat on top of each other and welded together by their edges.

DE 19825158 C1 also describes a disposable bag for a hemodialysis device or a peritoneal dialysis device that preferably has a concentrate for the preparation of dialysis fluid. This bag may consist of a chamber in which the used fluid is disposed below the new dialysis fluid in the course of the dialysis procedure. Alternatively, the disposable bag may also contain a film that divides the bag into two chambers, in which the new dialysis fluid is present in one chamber of the bag and the used fluid is passed to the other chamber during the dialysis procedure. .

A disadvantage of the glass containers mentioned above is that rapid reuse is not possible due to the laborious disinfection step. However, the disposable bags, which do not have this disadvantage, have not yet solved the problem that in the case of introduced granulated material to be dissolved in water, the different constituents of the granulated material react with each other during storage of the bag including the granulated material, with the result that there is no storage stability for a certain period of time. In addition, dialysis fluids that are prepared by dissolving granulated material that contains all the necessary constituents often have the problem that as a result of an undesired reaction of different constituents, not all granulated material is dissolved. The problems mentioned above often lead to the degradation or agglomeration of at least one of the concentrates provided. In addition, it is important to control the pH correspondingly while the solvent is being poured into the bag with granulated material, so that unwanted precipitation is avoided during dissolution of the granulated material in the fluid. If the aforementioned problems occur, the dialysis fluid is not suitable for hemodialysis or peritoneal dialysis and should be discarded together with the bag.

In addition to glucose, or other components that cannot contribute to the electrical conductivity of a fluid dissolved therein, and physiologically essential ions or salts, dialysis fluids must have a pH in the neutral range. A pH is set in the neutral range by adding an acid component and a basic component. These acid components

ES 2 725 007 T3 and basic must necessarily be physiologically compatible. Therefore, carbonate salts, for example sodium hydrogen carbonate, are preferably used as a basic buffer component. The solution must contain calcium and magnesium ions, in addition to sodium and potassium ions, as well as physiologically essential ions. A dialysis fluid is prepared more often from a single concentrate that is introduced into the embedded bag in the case of DE 198 25 158. If such concentrates containing easily soluble calcium or magnesium salts and, as a basic buffer component, a (bi) carbonate salt, are stored for a long time, then the problem arises, at least in atmospheric humidity conditions, that components can react with each other and therefore form poorly soluble calcium or magnesium carbonate. Also, poorly soluble calcium or magnesium carbonate precipitates from a solution whose pH is not set in the ideal range of preferably &lt;pH 8. Therefore, it is disadvantageous to introduce a concentrate with all the necessary physiologically essential components together in a bag, since such systems cannot be stored for a long time due to the problems mentioned above and during dissolution in a fluid there is a pH greater than 8 in areas of the solution, with the result that unwanted precipitation occurs.

WO 2007/144427 A2 refers to a container for providing a medical solution comprising a plurality of compartments separated by compartment dividers that are broken when sufficient pressure is applied by a liquid or gas introduced into the container. WO 2007/144427 discloses a container comprising three compartments, one of which contains a concentrate that can contribute to the electrical conductivity of a fluid, for example, sodium chloride dissolved in water, the other two compartments contain glucose powder . EP 1 621 177 A2 relates to a pharmaceutical container for storing pharmaceutical substances comprising at least one removable seal comprising at least two substantially straight sections that are connected by a curved rupture zone that can be opened manually. The container may include three chambers filled with administrable fluids, for example, carbohydrates and amino acids or electrolytes containing aqueous solutions and a lipid emulsion.

Therefore, an object of the present invention is to provide a multi-chamber bag comprising at least three different concentrates that are present in different cameras, and comprising a type A camera, and two or more type B cameras, in which one of the at least three different concentrates is a first concentrate, which cannot contribute to the electrical conductivity of a fluid in which the concentrate dissolves and two of the at least three different concentrates are concentrated seconds, each of which can contribute to the electrical conductivity of a fluid in which it dissolves the concentrate, whose bag has one or more of the advantages indicated below.

The object mentioned above is solved by teaching the independent claims.

A method of dissolving / mixing a concentrate in / with a fluid, a method for the production of a medical fluid dissolving concentrates or a disposable bag having, among others, the following advantages is disclosed in this document:

- high ease of use through an all-in-one concept and high application security;

- high flow rates during fluid filling;

- low use of materials;

- optimal / rapid dissolution of concentrates;

- contamination is avoided by laborious connection of individual components for the preparation of the solution;

- storage stability of the starting materials (ie without decomposition, degradation or agglomeration of glucose, without conversion of dicarbonates into CO2, without precipitation of calcium carbonate);

- controlled preparation of a solution from dry concentrates by sequential dissolution of the different components of dry concentrate, in which the formation of calcium carbonate precipitations can be avoided and the desired pH can be set;

- stability in storage of the solution after preparation from dry concentrates, without precipitation of calcium carbonate during storage and with the result that the pH remains stable in the solution,

- find a way to measure, by conventional methods, if 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 In the case of electrolytes, the concentration is proportional to the change in conductivity; however, some essential substances for medical solutions cannot be measured by this method, since they do not contribute to conductivity).

ES 2 725 007 T3

In a first aspect, a method of dissolving / mixing a concentrate in / with a fluid having the following steps is disclosed:

(a) providing a concentrate (5) in a chamber of a multi-chamber bag, in which the cameras (2, 3) of the multi-chamber bag are separated from each other by a separation device (4, 4a), and (b) introducing a fluid into one of the chambers (2, 3) of the multi-chamber bag, (c) tearing apart the device (4, 4a) between the chambers (2, 3) of the multi-bag chambers introducing the fluid, and (d) diluting / mixing the concentrate (5) in / with the fluid

In other words, the method mentioned above is a method of preparing a dialysis fluid with the steps mentioned previously (a) through (d). In a preferred embodiment, the dialysis fluid is a sterile dialysis fluid.

The method of the first aspect is hereinafter referred to as "first method".

In a further aspect, the concentrate is preferably provided in a type B chamber of the multi-chamber bag comprising a type A camera and a type B camera. It is preferred that the multi-chamber bag of the first method contain at least two, most preferred three and most preferred four type B cameras. Preferably, two of the type B chambers are chambers that open at the same time or one opens before the other when the fluid is introduced, preferably in the type A chamber. Preferably, the 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 that the chamber containing the concentrate with the acid component is opened. A third or fourth chamber of type B may contain a concentrate with the basic component as defined below. It is further preferred that these chambers be opened later than the first and second type chambers from the point of view of preventing the decomposition, degradation or agglomeration of the first concentrate.

An additional aspect refers to a method for the production of a medical fluid that has the following stages:

(e) providing a multi-chamber bag (1) comprising a camera (2) of type A, a first camera (3) of type B and a second camera (3a) of type B, in which the first camera of Type B comprises a first concentrate (5) that does not contribute to the electrical conductivity of the medical fluid and the second type B chamber comprises a second concentrate (5a) that contributes to the electrical conductivity of the medical fluid, wherein the first type B chamber and the second type B chamber are separated from the type A chamber by means of separation devices (4, 4a), (f) introducing a fluid into a type A chamber, (g) tearing apart the separation devices between the chambers by introducing the fluid, and (h) dissolving / mixing the concentrates in / with the fluid, characterized in that by introducing the fluid, the separation device of the first type B chamber is torn before or , even more preferred, while the separation device of the second type B chamber is torn,

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

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 be separated from the second type B chamber by an intermediate space that is constituted by a part of the type A chamber, that is, the separation device of both cameras of Type B separate these cameras from the type A camera individually.

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

It should be understood that the differentiation of the cameras from the multi-camera bag into "type A camera" and "type B camera" means that the elastic multi-layer stretch multi-chamber film bag consists of at least two cameras in the case of the first method, and of at least three cameras in the case of the second method. These two (not according to the invention) or three chambers can be the same in one embodiment according to the invention, or they can perform the same function in the bag, and different in another embodiment according to the

ES 2 725 007 T3 invention, as seen from the following embodiments. If, in the following embodiments, there is more than one type B camera, then it covers cameras that have the same mode of operation and can have the same shape, but also different shapes.

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

In addition to the type A camera and two type B cameras, the multi-camera bag according to the invention may also comprise additional type B cameras. In preferred embodiments of the present invention, the multi-chamber bag contains a type A camera and a total of two type B cameras or a type A camera and a total of three or four type B cameras. Each of the cameras, therefore also the additional type B cameras, are separated from each of the other cameras by separation devices. The separation devices tear when the fluid is introduced. Preferably, each of the type B cameras has its own separation device so that between the separation devices of the type B cameras is at least a part of the type A camera.

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

If the multi-chamber bag contains a total of at least three cameras, according to the invention they are present in these concentrates of different composition. However, it is also conceivable that if there is a total of three or more chambers, a concentrate of equal composition is present in two or more chambers.

It is particularly preferred in all the embodiments disclosed herein that the multi-chamber bag comprises at least a first and a second concentrate, as defined for example in the case of the second method, but is also preferred in the first embodiment. The first concentrate is thus a concentrate that does not contribute to the electrical conductivity of the resulting (medical) fluid. The second concentrate is thus a concentrate that contributes to the electrical conductivity of the resulting (medical) fluid. The first concentrate is thus a substance that cannot be dissociated in solution in anions and cations or is a substance that is present in an amount so low that the contribution to conductivity is not characteristic. These substances may be: pharmaceutical, active ingredients, or in particular in the field of dialysis: osmotic, such as glucose, fructose, galactose, sorbitol, amino acids, polymeric osmotic 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 thus a concentrate comprising a compound that can be dissociated into anions and cations, such as for example electrolytes.

Due to the aforementioned tear of the separation device (s) between the type A chamber and the type B chamber (s), a resulting chamber is formed, the volume of which comprises the sum of the volumes of the Type A camera and Type B camera (s). In this way, the granulated material of different chambers can dissolve in the fluid by introducing 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 breakage opening or tearing of the separation device (s), a resulting chamber is formed in which all the concentrates / concentrate is dissolved in the solvent.

In a further embodiment, the bag preferably comprises a type A chamber and two type B chambers, in which each of the chambers contains a different concentrate from each of the other concentrates.

In a further embodiment of the present invention, the bag preferably comprises a type A chamber and three type B chambers, in which 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 concentrate is concentrated as the second concentrate, but preferably different from each other.

In accordance with the present invention, the bag contains at least three (one first and two concentrates as the second concentrate) different concentrates that 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 guaranteed. The second concentrate may be a concentrate of an acid component or a concentrate of a basic component as defined below. In accordance with the present invention, one of the second concentrates is an acid concentrate containing an acid component and another of the second concentrates is a basic concentrate or buffer containing a basic component or buffer. The first concentrate is preferably a concentrate comprising glucose or in which glucose exists without any acid component. The concentrates

ES 2 725 007 T3 may be present in liquid form dissolved in a liquid, preferably RO water or a physiologically compatible water, but also in dry form as a powder or granulated material, as well as in the form of semi-liquid suspension concentrates. Particularly preferably, the concentrates are present in dry form or as concentrates in semi-liquid suspension. 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 particularly preferably used. The basic component, or buffer component, is preferably an (bi) carbonate of an alkaline salt, preferably sodium hydrogen carbonate. The acid component concentrate may also additionally contain physiologically compatible / necessary salts, such as sodium chloride, potassium chloride, calcium chloride or magnesium chloride. In addition to the basic or buffer component, the concentrate of the basic or buffer 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 concentrate of the basic component or buffer 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 of the concentrates may (n) contain glucose in addition to the mentioned components. To avoid unwanted glucose breakdown during storage of the bag filled with concentrates, the bag according to the invention contains a total of three or more chambers, with the result that three different concentrates are present separated in different chambers. Then, in the case of the first method, a concentrate can be introduced in the type A chamber and the two additional concentrates in each case in a type B chamber. Alternatively, the type A chamber may also not be filled (preferably in the second method) and the three different concentrates may be introduced into a total of three type B chambers. However, it is also possible that there are a total of five cameras, namely a type A camera and four type B cameras, in which the type A camera is not filled and two type B cameras are filled with the same concentrate and the two additional type B chambers each contain an additional concentrate. Providing 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 buffer. This is advantageous with respect to the resistance of the concentrates to the breakdown, degradation or agglomeration of glucose during storage.

The proportions of acidic component with respect to basic should be chosen such that during the dissolution of the concentrates the pH is preferably less than 8 but greater than 6, preferably in the range of from 6.5 to 7.8, more preferably in the range from 6.8 to 7.6, even more preferably in the range from 7 to 7.5. A pH that is too high is disadvantageous, since 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. A too low pH is also disadvantageous, since otherwise carbon dioxide is released from the hydrogen carbonate, which in turn leads to an increase in the pH, which is disadvantageous for the reason mentioned above.

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

The above-mentioned amounts of the components mentioned in the concentrates should be chosen such that by adding a certain amount of solvent, in particular physiologically compatible water, the specific electrical conductivity of the resulting total solution is in the range of from 10.00 to 17 .00 mS / cm, preferably from 11.00 to 15.00 mS / cm, even more preferred from 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. The 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 methods mentioned above is preferably a film bag that preferably consists of a flexible plastic film. In a further embodiment, the film bag is preferably formed of an individual plastic layer or a multilayer plastic film, wherein the innermost film layer is preferably a weldable film layer. The separation device between the type A chamber and the type B chamber (s) is preferably formed as a tear seam by welding two opposite inner film layers in the bag. Therefore, in this embodiment, by tear seam means a linear welded joint of two opposite inner sides of the bag. The tear seam preferably runs in the bag so that the type B chamber (s) is present (s) separated from the type A chamber and is separated (s) of additional type B cameras, preferably in the mode defined above, ie the interior spaces of the cameras are not connected. This is also true for several type B cameras possibly present. However, when the fluid is introduced, the separation device (s) are torn apart, 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.

ES 2 725 007 T3

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 joint linear weld and a resulting chamber is formed, the volume of which 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 torn seam in the multi-chamber bag, there may be small discrepancies between the volume of the resulting bag and the sum of The chamber volumes of the multi-chamber bag compared to the resulting bag (after the tear seam opening).

In a preferred embodiment of the present invention, the multi-chamber bag collectively comprises four type B cameras. The first and second type B cameras mentioned above are thus designed in a manner in which their separation devices are opened before. that the separation devices of the third and fourth chambers are opened. The first type B chamber preferably comprises a first concentrate as mentioned above. The second type B chamber preferably comprises a second concentrate that is preferably the acid component concentrate. The third and fourth chambers both preferably comprise a second concentrate that is a concentrate of the basic component.

In a further alternative embodiment of the present invention, the type B chambers are formed by an inner bag inside the type A chamber that represents the separation device. In other words, inside the type A camera, whose outer limit substantially represents the outside of the multi-chamber bag, there are additional bags representing the type B cameras. In this additional alternative embodiment with the so-called inner bags representing the type B chambers, the fluid is preferably introduced into this inner bag. In addition, the fluid can also be introduced into the type A chamber, in order to possibly introduce fluid into it, or dissolve a concentrate possibly present in the type A chamber by this fluid, before the type B chambers open and that the concentrate found in them enters the type A chamber in dissolved or semi-dissolved or undissolved form. The tearing of the separation device (s) of the type B cameras that occur in the form of inner bags in the multi-chamber bag takes place tearing to open a tear seam present in the wall of the (s) additional inner bag (s). In other words, the inner bags that form type B chambers have a tear seam that is preferably in the form of a perforation. By introducing fluid into the type B chambers, a pressure acts on the tear seam which causes it to tear, and the concentrates present in the type B chambers, together with the fluid, enter the resulting bag and form a solution With the concentrates.

Preferably , the tear seams of the inner bag / bags are called detachment seams. These are preferably produced by heat treatment and the joining of two opposite film sections. The detachment seams have the advantage that they are generally soluble without film breakage.

Preferably, the walls of the inner bag / bag have, in the region of the detachment seam, a detachment seam strength in the range of from 0.2 to 15 N / 15 mm, particularly preferably in the range of from 0.3 to 11 N / 15 mm, most preferably in the range from 0.5 to 8 N / 15 mm. By "shear seam strength" is meant the tensile stress at the time of tearing of the shear seam. The shear seam strength can be determined by known methods according to ASTM D 1876-01, ASTM F88-07 or based on EN ISO 527-3. For this reason, in the present application, the force with which a 15 mm wide strip of film is torn along the detachment seam was measured in Newtons. The film strip in this case is a T-shaped test strip. The detachment seam is in this case longitudinal to the width of the strip.

In the event that the multi-chamber bag of the present invention 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 dissolved therein. A deviation of 1 mS / cm, preferably 0.1 mS / cm, to which the concentrate contributes in an already prepared solution, is not considered appropriate for monitoring the conductivity during obtaining the solution. The second type B chamber contains a concentrate that contributes to the electrical conductivity of the fluid when dissolved in it. In this case, the tear strength of the detached seam (detachment) of the tear of the separation device of the first type B chamber is equal to or less, preferably lower than the seam strength of the seam detachment (detachment) ) tearing of the separation device of the second type B chamber. This also occurs for additional type B chambers that comprise concentrates that contribute to the electrical conductivity of the fluid when dissolved in it. However, it is particularly preferred that additional type B cameras be opened later than the first and second type B cameras.

The fact that the shear seam strength of the first type B chamber is as high as the shear seam strength of the other type B chambers leads to the advantage that the release of the concentrate (first) that does not contribute to electrical conductivity can be measured indirectly by the change in conductivity when the concentrate (second) that contributes to conductivity is released, since due to the equal or lower shear seam strength, the first concentrate is released to the fluid when the second concentrate is released to the fluid. In this way it can be guaranteed that the first

ES 2 725 007 T3 concentrate always dissolves in the fluid before or at the same time that other concentrates dissolve in the fluid.

In order to achieve a fast filling speed accompanied by the dissolution of all the concentrates, it is advantageous if the bag has a conical or decreasing section in the form of a V towards its lower end. Preferably, the cone has an angle in the range of from 30 ° to 75 °, particularly preferably from 45 ° to 65 °, most preferably from 55 ° to 65 °. The fluid is introduced into the type A chamber or type B chambers through (a) feed opening (s) located at the top end of the bag. It is advantageous for the purpose of the best dissolution of the concentrates in the type A chamber if a pipe runs from the feed opening in the upper area of ​​the bag to the bottom of the bag, with the result that the fluid in the Type A camera enters the bag at the bottom. This is also true for the feed openings of type B cameras that are present in the main bag in the form of the inner bags. To improve the dissolution of the concentrates, a spray nozzle is preferably attached to the lower end of the pipe, through which the fluid enters the type A chamber. In addition, the pipe leading through the feed opening into the type A chamber or the type B chamber (s) is preferably connected to the feed opening so that the only connection with the outside of the bag is through channeling.

An embodiment of the present disclosure relates to a multi-chamber bag (bag) preferably containing a type A camera and at least one type B camera, in which the cameras are separated by a separation device, in which At least sections of the separation device have a predetermined breaking point. By a predetermined breaking point it is generally meant a point that breaks as a result of the application of a force and therefore represents a tear of a wall. In the present invention, by a predetermined breaking point it is meant in particular a part of the separation device or a whole of the separation device that, through exposure to a force within the chamber, causes the spaces of the chambers to enter in contact with each other through the tearing of the separation device or a part of the separation device (predetermined breaking point). More particularly, by a predetermined breaking point, according to the invention, an area within the bag representing a part or a whole of the separation device is meant. The predetermined breaking point is preferably formed by a detachment seam. The detachment seam preferably has a detachment seam strength in the range of from 0.2 to 15 N / 15 mm, particularly preferably in the range of from 0.3 to 11 N / 15 mm, most preferably in the range from 0.5 to 8 N / 15 mm. Seam shear strength is measured using the methods mentioned above.

In a further embodiment of the present disclosure, 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 form and / or liquid form. The definition of the concentrate (s) mentioned above also applies to the concentrate (s) mentioned in this case.

In the embodiment where concentrates are already present in the multi-chamber bag, one of the concentrates is present in the type A chamber and the other in a type B chamber, or two concentrates in type B cameras are present. respective are separated from each other by (a) separation device (s). At least sections of this / these separation device (s) have a predetermined breaking point. This predetermined breaking point is simply defined as above.

A preferred embodiment of the present invention is a multi-chamber bag preferably comprising a type A camera, a first type B camera and a second type B camera, wherein the first type B chamber comprises a first concentrate that cannot contribute to the electrical conductivity of a fluid in which the concentrate dissolves and the second type B chamber comprises a second concentrate that cannot contribute to the electrical conductivity of a fluid in which the concentrate dissolves. The three cameras are preferably separated from each other in a manner as mentioned above. Then it is particularly preferred that the shear seam strength of the shear seam of the predetermined breaking point of the separation device of the first type B chamber is equal to or, preferably, less than the seam shear strength of the seam detachment. of detachment of the predetermined breaking point of the separation device of the second type B chamber. 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 cameras, the shear seam strength of the detachment seam of the predetermined breaking point of the separation device of the first type B chamber is preferably lower than the shear seam strength of the detachment seam of the predetermined breaking point of the separation device of the additional type B chambers.

The mentioned bags are preferably film bags. Preferably, the bags according to the invention are composed of a film consisting of a piece. In other words, the film that defines the external dimensions of the bag is composed of a piece of film. The multi-chamber bag according to the invention or the multi-chamber bag used in the method mentioned above is preferably sterile inside. The state of the materials and articles achieved through a method by which the materials and

ES 2 725 007 T3 items are released from live microorganisms called sterile. In practice, however, complete sterilization is not 100 percent true. Therefore, by "sterilization" or the term "sterile" means a reduction in the number of microorganisms that can be multiplied by a given factor according to the field of use. Among other things, it is meant by this that the residual level of microorganisms that can be multiplied in a unit of the sterilization product is at most 10-6 colony forming units, that is, a maximum of one microorganism that can be multiplied in a million units of sterilization product treated identically. Sterilization can be carried out by physical (thermal, irradiated) 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 or multilayer film is preferably a weldable film layer. The separation device preferably comprises a tear seam that is formed by welding two opposite innermost layers of film. By a tear seam it is meant in relation to this a tear seam as defined above in relation to the method according to the invention. The tear seam is preferably a detachment seam.

In an alternative embodiment, the separation device is formed by forming in the bag one or more additional inner bags within the type A chamber that represents the type B cameras. In this embodiment, the type A chamber may contain a feed opening for the fluid, but the inner bags inside the type A chamber that forms (n) the type B chambers can also have feed openings through which the fluid is introduced into the type B chambers. When the fluid is introduced, a pressure acts on the bag wall of type B chambers that preferably have a tear seam that is defined as above. Through this pressure, the separation device (s) or the wall (s) of the inner bag is torn apart, with the result that the contents of type B chambers enter the type A chamber, with the result that all dissolved or partially dissolved concentrates of type B chambers enter the type A chamber and mix.

The volumetric capacity of the bags once the separation device (s) has been torn is 30 to 100 liters, preferably 40 to 90 liters, particularly preferably 50 to 80 liters and so extremely preferable from 55 to 70 liters.

As already mentioned above, the bag may contain a powder and / or liquid concentrate 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, in which each of the chambers in each case contains a powder and / or liquid concentrate. These concentrates are preferably of different composition, in which what was said above in relation to 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 a type A chamber and three type B chambers, in which the three chambers of type B each contain a powder and / or liquid concentrate. .

If the bag contains a type A chamber and two type B chambers, then there may be a concentrate, as defined above, with an acid constituent in one of the type B chambers and a concentrate with a basic or buffer constituent in an additional type B camera. In this case, glucose can be mixed with one or both concentrates. However, in order to avoid 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 realization of the three chamber bag with a type A camera and two type B cameras, the concentrate with the basic or buffer component is present in the type A chamber, and the concentrate with the component acid is present in one 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 cameras, specifically a bag comprising a type A camera and three or more type B cameras, the three different concentrates are preferably present in the type B cameras.

In the above-mentioned embodiments of the bag, it is preferred that the first concentrate is first dissolved by the fluid or 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 buffer component are located respectively, then it is advantageous to arrange the chambers so that the first concentrate is dissolved first in the solvent, the concentrate with the acid component at the same time or second and the concentrate with the basic component last. This has the advantage that the pH remains stable in the preferred range mentioned above, and less CO2 is formed than is otherwise produced. In an alternative embodiment, a concentrate is dissolved with the acid component rather than a concentrate with the basic component. The evolution of CO2 gas must be considered and measures to compensate for CO2 pressures must be taken into account. Sequential dissolution in the order mentioned is also advantageous in order to guarantee a homogeneous dissolution process. If dry concentrates are used, the smaller concentrate components will be

ES 2 725 007 T3 dissolve more rapidly and the risk of agglutination is lower. 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 of type B) can be achieved by means of the directed action of the chambers with internal filling pressure (inflation pressure). In the case where the cameras in the multi-chamber bag are formed by welding opposite inner film sides of the bag, the bag is filled from below through the power line of the type A camera. In one embodiment, in the one with more type B chambers, the chamber arranged below opens firstly due to the pouring of the solvent into the type A chamber, due to the filling pressure (inflation pressure) in the detachment seam. The chronological order of the opening by loosening / breaking of the detachment seam can be controlled through the corresponding arrangement of the chambers. Therefore, the sequential addition of the concentrate to the resulting chambers that are formed due to the opening of the detachment seam can be guaranteed. Thus, 2, 3, 4 or 5 cameras (of type B) can be arranged, some deflected above the other, which are opened by torn in succession. The loosening process is therefore easily controlled through the design of the bag.

In the first method of the present disclosure, it may also be preferred that the first concentrate is first dissolved by the fluid or 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 buffer component are located respectively, then it is advantageous to arrange the chambers so that the first concentrate is first dissolved in the solvent, the concentrate with the acid component at the same time or second and the concentrate with the last basic component.

In the aforementioned embodiments, the volume of the type A chamber may be a multiple of the volumes of the type B cameras. Once the process of filling the multi-chamber bag with the fluid is completed, the resulting chamber after the tearing of The separation devices comprise a volume that substantially corresponds to the volumes of all the chambers of the multi-chamber bag, specifically those of the type A chamber and the type B chamber (s). The volume of the type A chamber of the multi-chamber bag preferably comprises a large part of this resulting chamber in which the solution or suspension is located after the tearing 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, still more preferably 4 to 12 times, most preferably 5 to 10 times) greater than the sum of the volume / volumes of the type B chamber (s).

In all the aforementioned embodiments, the size of the type B chambers is preferably determined by the volume of the concentrates contained therein, but may also be 1 to 4 times larger (preferably 2 to 3 times larger) than is required. The volume of the concentrate. In general, it should also be indicated at this point that, when the type B chamber (s) is being filled with fluid, the loosening process is already partially taking place in the chamber (s) Type B, without the separation device is already tearing. This prior loosening process can be optimized through an adequate choice of the hypothetical void volume of the type B chamber (s) 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-loosening process can be (given the constant tear resistance of the separation devices).

However, in an alternative embodiment, the volume of the type A chamber may also not be a multiple of the sum of the volume / volumes of the type B chamber (s), but exactly as large as or smaller than the volume of one of the type B cameras. In this case, the dimensions of the type A chamber preferably do not differ substantially from those of the type B camera (s). One camera is connected to the next one (type A camera and type B camera (s)) by means of separation devices. The type A camera can be found next to one or more type B cameras, but also between two or more type B cameras. In this sense, the type A camera cannot be distinguished from the type B cameras. Through the simultaneous or successive tearing of the separation device (s) during fluid filling, 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 introduced into the second chamber that is preferably below it, during the successive tearing of the separation devices. The subsequent tearing of the second separation device then leads to the combined contents of the first and second chambers being introduced into the third chamber preferably below it, and so on (as appropriate). Preferably, the fluid is poured with a feeding device mentioned above in 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 the type B camera (s) in particular by this feature.

In the case where the type B chambers are formed by inner bags in the type A chamber of the bag, the arrangement of the inner bags is of minor importance, since the detachment seams are not divided as a result of the filling of the type A chamber with fluid, but they open by filling the respective type B chamber with fluid. As a result of filling, a filling pressure (inflation pressure) acts on the detachment seam of the inner bag forming the respective type B chamber. If filling pressure

ES 2 725 007 T3 reaches a certain level, the detachment seams open and the mixture / solution of the respective fluid concentrate enters the type A chamber. As for the arrangement of several type B chambers, it is only necessary to have The contents of a camera set out above are not poured into an inner bag of an additional type B camera. In this sense, an incomplete dissolution of the corresponding concentrate is avoided. The sequential opening of the type B chambers in the order mentioned above is either guaranteed by the detachment seams that have resistances of different detachment seams correspondingly graduated with the same filling rate of the type B chambers with fluid, or by means of the fluid that is being introduced into the type B chambers in sequence with the same detachment seam resistances.

All the mentioned characteristics with respect to the multi-chamber bag according to the invention are also characteristics that the multi-chamber bag can have in the method mentioned above according to the invention.

Furthermore, it is advantageous with respect to the filling speed or the dissolution behavior of the concentrates in the bag that the bag has a tapered or V-shaped decreasing section towards its lower side. The conical or V-shaped end of the bag is located on the opposite side of the feed opening of the bag. The cone preferably has an angle in the range of from 30 ° to 75 °, particularly preferably from 45 ° to 65 °, most preferably from 55 ° to 65 °. In addition, it is advantageous if a pipe is passed through the feed opening to the bottom of the bag, with the result that fluid to be introduced enters the bag in the type A chamber at the bottom. The pipeline is normally connected to the feed opening so that the only opening to the outside of the bag is through the inside of the pipe. The pipe is preferably a plastic tube.

If one of the bags mentioned above according to the invention is used in hemodialysis or peritoneal dialysis, then the chamber that results after the tearing of the separation devices, the volume of which substantially comprises the sum of the volumes of all the chambers, preferably represents a space to maintain new dialysis fluid. Through the aforementioned feed opening, which can also serve as an outlet opening, the freshly prepared dialysis fluid can be used in a peritoneal hemodialysis or dialysis device. The dialysate used 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 also a film bag that surrounds the entire exterior of the bag according to the invention. A feed opening for the dialysate used in the surrounding bag preferably leads through a tube through the inlet or outlet opening of the bag according to the invention all the way through the type A chamber and ends in the bag surrounding the bag according to the invention which is to collect the dialysis fluid used. Preferably, the bag surrounding the bag according to the invention, which is for collecting the dialysis fluid used, is composed of the same material as the bag according to the invention.

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

The bag used in the process according to the invention or the bag according to the invention or the inner bags preferably consist of a multilayer film. The multilayer film preferably has an elongation to tear in the longitudinal direction of the extrusion of the film from 250% to 850%, preferably from 400% to 800%, more preferably from 500% to 750% and most preferably from 600% at 700%, and in the transverse direction of the extrusion 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 tearing or elongation at break means the ratio in percentage of the change in length AL (at break) with respect to the starting length. It expresses the ability of a material to follow changes in shape without cracking. Tear elongation is measured in the tensile test according to DIN 53455.

A large capacity of the film to change its length in the longitudinal direction of the extrusion of the film in the aforementioned range has the advantage according to the invention that, although it is being filled with or emptied of dialysate (used or new), the bag experience a change in volume without cracking before the upper limits given. This entails the additional advantage that when it is not filled, only a small amount of material is required, but nevertheless there is a large volume capacity when it is filled. In this way a product can be provided that carries only a small amount of waste material. This is particularly advantageous from the point of view of the environment.

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 joined together by adhesion.

It is preferred, within the framework of the present invention, that the multilayer film is joined in from 2 to 10 layers, in which a 2 to 5 layer structure is more preferred and a 3 or 4 layer structure is particularly preferred . The multilayer film can be produced according to any procedure known to an expert

ES 2 725 007 T3 in the art as suitable for the purpose according to the invention.

In addition, the multilayer film preferably has a tear strength in the longitudinal direction of 300 N / mm.² at 350 N / mm², preferably 310 N / mm² at 340 N / mm² and more preferably 320 N / mm² at 330 N / mm², and in the transverse direction of the 220 N / mm film extrusion² at 270 N / mm², preferably 230 N / mm² at 260 N / mm² and more preferably 240 N / mm² at 250 kp / cm².

By "tear resistance" is meant the tension of tension that is exerted on an article at the time of tearing. Tear resistance is measured in the tensile test according to DIN 53455. A tear resistance below the lower limit mentioned above is disadvantageous, since otherwise the bag is torn prematurely through the excess extension. Although the bag is very resistant to tearing above the upper limit mentioned, it is not sufficiently extensible.

In addition, the multilayer film preferably has a transverse extension ratio µ in the elastic rubber 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 Poisson's ratio, is defined as the ratio of the relative change in thickness Ad / d with respect to the relative change in length ΔΙ / l after exposure to an external force or tension.

In addition, the multilayer film can be extended up to 500% by a force of preferably 45 N to 60 N, more preferably from 48 N to 62 N, most preferably from 52 N to 58 N. To measure the extensibility, apply evenly a weight corresponding to a specific force in N to a 15 mm wide film and the change in length is measured.

High extensibility has the advantage that the bag is small when it is not full and therefore easy to handle. In addition, the need for material is small as a result of the strong extensibility of the material. Therefore, a simpler manufacture and packaging of the material is also possible.

In the case of the bag according to the invention, the ratio of the external surface of the bag when filled to the maximum with respect to the external surface when not filled, is preferably in the range of preferably&gt; 2/1, more preferably &gt; 5/1. The normal upper limits are approximately 8/1 to 12/1 for example 10/1 or 9/1. However, higher reasons according to the invention are also provided.

By "external surface" is meant the surface of the bag that can come into contact with its surroundings (air) when it is full and also when it is not full. The term "when full to the maximum" is described by the maximum size of the bag in which the bag still does not form cracks and therefore still does not tear.

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

The property of the increase in surface area in relation to the amount of filling ensures that the multilayer film of the bag is always under pressure during filling, with the result that as it fills more and more, this pressure increases and disappears more and more any fold in the multilayer film that might be present when it is not full. This has the advantage according to the invention that the free introduction of folds of the bag into a reservoir of a medical device, in particular a dialysis machine, is guaranteed. Therefore, the complete withdrawal of the fluid from the bag is also guaranteed.

In a further embodiment of the present invention, the ratio of the volumetric capacity of the bag according to the invention when filled to the maximum with respect to the volumetric capacity in the state in which the multilayer film is not extended is preferably&gt; 3 / 1, preferably&gt; 5/1. Typical non-limiting intervals are 3/1 to 12/1, more preferably 5/1 to 11/1, still more preferably 7/1 to 10/1 and most preferably 8/1 to 9/1. However, other higher upper limits according to the invention are also possible.

By "volumetric 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 multilayer) are preferably achieved by a film of three or more layers, preferably three layers. The two outer layers of the film must be chosen from a material that prevents damage to these layers (for example due to the handling of the film) trigger unwanted predetermined breakage points, which lead to tearing of the bag when the bag formed from this it is filled later and when the bag is subjected to extreme extension. Therefore, the two outer layers of the film, unlike the inner layer (s), are preferably more robust against mechanical influences. In addition, the film should preferably not tend to stick during storage of a multi-chamber bag according to the invention and any heat sterilization. In contrast to this is the demand to produce shear seams with a corresponding welding tool preferably at relatively low temperatures. The seams of detachment are

ES 2 725 007 T3 characterized in that they are produced by welding or partial bonding of the films by heat treatment and contact pressure. Preferably, therefore, the temperature for the formation of the detachment seams is below the welding temperature for permanent welded seams. A film that is used according to the invention should preferably have a high elastic extensibility without a high exposure to force. However, in most cases, such films tend to form unwanted bond connections in themselves without a pressure effect of the welding tools corresponding to a common heat sterilization temperature of 100 to 120 ° C, during 5 to 15 minutes (approximately 10 minutes) at a pressure of between 1.5 and 2.5 bar (approximately 2 bar). Therefore, a film for a bag according to the invention should preferably be a compromise between technically opposed needs of heat sterilization capacity, mechanical robustness, elastic extensibility, producibility of permanent and removable joint seams and good divisibility of the films after heat treatment. As for the elastic extensibility of the film and of the bag produced therefrom, a uniform extension is required due to exposure to force or the filling of the bag. If the bag extends in a non-uniform manner, there is a risk that individual areas will be excessively extended while other areas are not or are less extended.

That is, the multi-chamber bag according to the invention or multi-chamber bag of the methods according to the invention is preferably a film bag, in which the film is an elastic extensible film that preferably extends when the fluid is introduced into a of the cameras. The bag extends similar to a balloon when filled with diluent and contracts when fluid is removed from the bag. The bag is made from a film that shows an elastic tension behavior so that the plastic tension characteristics are preferably suppressed.

Exemplary film structures are:

Type 1 film: Inner layer: layer thickness: 10 μm, 100 parts of styrene, ethylene, butylene or propylene hydrogenated styrene block copolymer, for example SEBS Septon 2005, Kuraray, 70 parts of random polypropylene with ethylene as comonomer, PP23M10cs264 Rexene, Huntsmen

Middle layer: layer thickness: 100 μm, 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 μm, random polypropylene, 60% Bormed SC 220 Borealis, styrene, ethylene, butylene or propylene hydrogenated styrene block copolymer, for example 40% of Septon 8004, Kuraray

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

Outer layer: analogous to the inner layer

Type 3 film: Inner layer: layer thickness: 10 μm, 100 parts of styrene, ethylene, butylene or propylene styrene block copolymer, for example Septon 2005, Kuraray, 70 parts of random polypropylene with ethylene as a comonomer, PP23M10cs264 Rexene

Middle layer: layer thickness: 100 .um, 40% Engage, Dow Chemical, 25% Tuftec 1062, 35% Septon 8004, Kuraray

Outer layer: analogous to the inner layer

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

They are shown in:

Figure 1 a section through a bag with a type A camera and two type B cameras, in which the separation device is present in the form of a tear seam.

Figure 2 a section through a bag with a type A camera and two type B cameras, in which the separation device or type B cameras are present in the form of a bag that has a predetermined breaking point at Shape of a torn seam.

Figure 3 a section through a bag having a type A camera and four type B cameras, in which the separation device is present in the form of a tear seam.

Figure 4 a section through a bag that has a type A camera and three type B cameras, in which the separation device (s) or type B cameras are present in the form of inner bags that have a tear seam as the default breaking point.

ES 2 725 007 T3

Figure 5 a bag with a type A camera and three type B cameras, in which the type B cameras are present separated from the type A chamber by a separation device in the form of a tear seam.

Figure 6 a section through a bag having a type A camera and four type B cameras, in which the separation device is present in the form of a tear seam.

Figure 7 a section through a bag having a type A camera and four type B cameras, in which the separation device is present in the form of a tear seam.

Figure 1 shows a section through a bag (1) with a chamber (2) of type A and two chambers (3, 3a) of type B, in which the separation device (4) is present in the form of a seam (10) tear. There is a concentrate (5) which is preferably a basic or buffer concentrate in the chamber (1) of type A. A pipe or tube (9) leads from the feed opening (8) into the chamber (2) of type A 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 fluid enters the chamber. The welded seam (7) represents an internal weld of the inner surface of the bag film that can be a tear seam within the meaning of the invention or represents a welded seam that has no predetermined breaking point. The chamber (2) of type A preferably contains a concentrate (5) with basic or buffer component, while the chambers (3, 3a) of type B preferably contain the glucose concentrate or the concentrate (5) with the acid component .

Figure 2 shows a section through a bag (1) with a chamber (2) of type A and two chambers (3, 3a) of type B, in which the separation device (4a) or the chambers (4a ) Type B are present in the form of an inner bag inside the type A chamber, in which this bag has a predetermined breaking point in the form of a tear seam (10a). The chamber (2) of type A and the chambers (3, 3a) of type B 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) extending into the concentrate (5) to the bottom of the chambers. A spray nozzle (6) that allows a better dissolution of the concentrate in the chamber (2) of type A is preferably connected to the lower end of the pipe (9) of the chamber (2) of type A. The chamber (2) of type A is preferably present in the form of a V that has a considerable decreasing section downwards, with the result that, in comparison with a square bag, a better dissolution behavior of the concentrates in the Type A chamber. The V shape of the type A chamber (2) is achieved by producing a welded seam (7) in the form of a V through opposite inner sides of the bag. The welded seam can be a tear seam within the meaning of the invention, with the result that, from a certain pressure that is produced by the pouring of a certain amount of fluid, it is divided and provides a greater space in Shape of a square bag. The concentrate (5) in the type A chamber is preferably a basic or buffer concentrate. The concentrates (5) in the type B chambers (3, 3a) are preferably a concentrate containing glucose, or the concentrate containing the acid component.

Figure 3 shows a section through a bag (1) having a chamber (2) of type A and four chambers (3, 3a, 3b, 3c) of type B, in which the separation device (4) or the separation devices are present in the form of a tear seam (10). When the chamber (2) of type A is filling with fluid through the pipe or the tube (9) through the feed opening (8), a force acts on the tearing seams (10), with the result that these are opened and firstly the concentrates (5) of the lower chambers (3, 3a) of type B dissolve first in the fluid introduced into the chamber (2) of type A and the concentrates (5) of the cameras (3b, 3c) of type B are then dissolved in the fluid as a result of tearing open of the tear seam (10) of these chambers. The pipe or tube (9) leading into the chamber (2) of type A has, at the lower end of the V-shaped area of ​​the bag, a spray nozzle (6) that guarantees the best dissolution of the concentrates (5) in the fluid. In addition, this bag (1) preferably has, in the lower area, an end of tapered or V-shaped decreasing section that is achieved by welding the opposite inner sides of the bag by means of a welded seam (7). This welded seam can be a tear seam within the meaning of the invention, which is divided under a corresponding pressure that acts as a result of the pouring of the fluid, with the result that a square bag is formed, or a solid welded seam, by which conserves the V-shape of the bag during the dissolution of the concentrates. The type B chambers (3, 3a) preferably contain the basic or buffer concentrate (5), while one of the type B chambers (3b, 3c) contains the glucose concentrate (5) or the concentrate (5) With the acid component.

Figure 4 shows a section through a bag (1) having a camera (2) of type A and three cameras (3, 3a, 3b) of type B, in which the device (s) (4a ) of separation or the chambers (3, 3a, 3b) of type B are present in the form of inner bags having a tear (10a) of tearing as the predetermined breaking point. Each of the chambers (3, 3a, 3b) of type B and the chamber (2) of type A have a feed opening (8) that makes it possible to introduce a fluid into the respective chambers through a pipe or a pipe ( 9). The tube or the pipe (9), in the chambers (3, 3a, 3b) of type B, preferably extends so much into the chambers that the fluid exits in the middle of the concentrates (5). The tube or the pipe (9) of the chamber (2) of type A leads into the lower end of the bag of decreasing V-shaped section and preferably has a

EN 2 725 007 T3 spray nozzle (6) for the best dissolution of the concentrates entering the type A chamber. The chambers (3, 3a, 3b) of type B each have a tear seam (10a) as a predetermined breaking point, which is torn at a certain pressure exerted as a result of the introduction of the fluid, with the result that the concentrates (5) of the chambers (3, 3a, 3b) of type B enter the chamber together (2) type A. The bag (1) surrounding the inner bags or the cameras (3, 3a, 3b) of type B, which essentially forms the chamber (2) of type A, has a V-shape at the lower end. The V shape is achieved by welding two opposite inner sides of the bag using a welded seam (7). The welded seam can be a tear seam within the meaning of the invention, which tears at a certain pressure produced by the introduction of the fluid, with the result that a rectangular bag is formed, or it can be a fixed welded seam by means of the which retains the V shape of the bag. The chamber (3a) of type B preferably contains the concentrate with the acid or buffer 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 camera (2) of type A and three cameras (3, 3a, 3b) of type B, in which the cameras (3, 3a, 3b) of type B are present separately of the chamber (2) of type A by a separation device (4) in the form of a tear seam. The tear seam is formed by welding two opposite inner sides of the bag (1) together so that the tearing seams are divided as a result of a pressure produced by the pouring of the fluid and the concentrates are combined in the chamber (2) type A. A pipe or tube (9) through which fluid can enter the chamber (2) of type A through a feed opening (8), extends into the chamber (2) ) of type A. 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 has a decreasing section in the form of a V at the lower end in the chamber (2) of type A, which is guaranteed by a welded seam (7). The welded seam (7) can be a tear seam within the meaning of the invention that is torn as a result of a pressure produced by filling with the fluid, with the result that a rectangular bag is formed, or it can be a seam Fixed weld that guarantees the V-shape of the bag even when filled with fluid. The concentrate (5) in the chamber (3) of type B is preferably a concentrate with a basic or buffer component. The concentrate (5) in the chamber (3a) of type B is preferably a concentrate containing glucose. The concentrate (5) in the chamber (3b) of type B is preferably a concentrate with an acid component. As with the provisions 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 the type A chamber in the preferred range according to the invention.

Figure 6 shows a section through a bag (1) which has a camera (2) of type A and four cameras (3, 3a, 3b, 3c) of type B, in which devices (4, 4a are present) , 4b, 4c) in the form of a tear seam (10). When the chamber (2) of type A is filling with fluid through the pipe or the tube (9) through the feed opening (8), a force acts on the tearing seams (10), with the result that these are opened and firstly the concentrates (5, 5a) of the lower chambers (3, 3a) of type B dissolve first in the fluid introduced into the chamber (2) of type A and the concentrates (5b, 5c) of the cameras (3b, 3c) of type B are then dissolved in the fluid as a result of tearing open of the tear seam (10) of these chambers. The pipe or tube (9) leading into the chamber (2) of type A has, at the lower end of the V-shaped area of ​​the bag, a spray nozzle (6) that guarantees the best dissolution of the concentrates (5, 5a, 5b, 5c) in the fluid. In addition, this bag (1) preferably has, in the lower area, an end of tapered or V-shaped decreasing section that is achieved by welding the opposite inner sides of the bag by means of a welded seam (7). This welded seam can be a tear seam within the meaning of the invention, which is divided under a corresponding pressure that acts as a result of the pouring of the fluid, with the result that a square bag is formed, or a solid welded seam, by which conserves the V-shape of the bag during the dissolution of the concentrates. Type B chamber (3) preferably contains a concentrate (5) that does not contribute to the electrical conductivity of the resulting fluid. The chamber (3a) of type B preferably contains a concentrate of the acid component (5a). Type B chambers (3b, 3c) both preferably contain concentrates of the basic component (5b, 5c). The bag also 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 also a film bag that surrounds 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 all the way through the chamber of type A and ends in the bag surrounding the bag according to the invention which is to collect the dialysis fluid used. Preferably, the bag surrounding the bag according to the invention, which is for collecting the dialysis fluid used, is composed of the same material as the bag according to the invention. The cameras (3, 3a, 3b, 3c) of type B are formed by a tear seam that is formed completely by welding the opposite inner sides of the bag.

Figure 7 shows a section through a bag (1) having a camera (2) of type A and four cameras (3, 3a, 3b, 3c) of type B, in which devices (4, 4a are present) , 4b, 4c) in the form of a tear seam (10). When the chamber (2) of type A is filling with fluid through the pipe or the tube (9) through the feed opening (8), a force acts on the tearing seams (10), with the result that these are opened and firstly the concentrates (5, 5a) of the lower chambers (3, 3a) of type B dissolve first in the fluid introduced into the chamber (2) of type A and the concentrates (5b, 5c) of the cameras (3b,

ES 2 725 007 T3

3c) of type B are then dissolved in the fluid as a result of tearing open of the tear seam (10) of these chambers. The pipe or tube (9) leading into the chamber (2) of type A has, at the lower end of the V-shaped area of ​​the bag, a spray nozzle (6) that guarantees the best dissolution of the concentrates (5, 5a, 5b, 5c) in the fluid. Furthermore, this bag (1) preferably has, in the lower zone 5, an end of tapered or V-shaped decreasing section that is achieved by welding the opposite inner sides of the bag by means of a welded seam (7). This welded seam can be a tear seam within the meaning of the invention, which is divided under a corresponding pressure that acts as a result of the pouring of the fluid, with the result that a square bag is formed, or a solid welded seam, by which conserves the V-shape of the bag during the dissolution of the concentrates. The chamber (3) of type B preferably contains a concentrate (5) that does not contribute to the electrical conductivity of the resulting fluid. The chamber (3a) of type B preferably contains a concentrate of the acid component (5a). Type B chambers (3b, 3c) both preferably contain concentrates of the basic component (5b, 5c). The bag also 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 also a film bag that surrounds the entire exterior of the bag according to the invention. fifteen 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 all the way through the chamber of type A and ends in the bag surrounding the bag according to the invention which is to collect the dialysis fluid used. Preferably, the bag surrounding the bag according to the invention, which is for collecting the dialysis fluid used, is composed of the same material as the bag according to the invention. The chambers (3, 3a, 20 3b, 3c) of type B are formed by a tear seam that is partially formed by welding the opposite inner sides of the bag.

Examples

Example 1: Production of a multi-chamber bag with granulated material:

A multilayer film of the aforementioned type 1 film 25 is folded in half on its side with the external dimensions of 45 cm X 66 cm, with the result that two sides of the film are opposite each other and form a two-layer film with rectangular cross sections (given a bag size of 45 cm X 33 cm), which are joined together on their sides in length. At 5 cm from the bottom edge (width side) and approximately 1 cm from the right edge (length side), the first half of a first granulated material is introduced (see below the quantity and composition) in a first sachet forming a circular linear detachment seam (0 of 12 cm) between the two inner sides of the film by thermal welding, with the result that the granulated material is enclosed by the detachment seam. Similarly, the second half of the first granulated material is introduced into a second bag at a distance of approximately 1 cm from the other side of length. In the same way, a second granulated material (see quantity and composition below) is introduced into a third bag at a distance of 3 cm from the seam of the first bag in the direction of the opposite width side and at a distance of approximately 1 cm from the length side (right side). Again, 3 cm from the second seam of the second sachet in the direction of the side of opposite width and approximately 1 cm from the side of length (right side), a third granulated material is introduced (see below the quantity and composition) in this fourth bag in the same way. The two halves of film are then welded together on the remaining three open sides 40, in which a gap (approximately 3 cm) is left on the side of width opposite the first sachet in the center of the edge and an additional gap on the side of width opposite this side of width at the edge, in case the two halves of film are not in each case welded together. A first plastic tube approximately 40 cm long that has a spray nozzle at the inner end and ends inside the bag is passed into the bag through this hole. A second plastic tube approximately 45 cm long is passed through the interior of the bag through both holes, with the result that it protrudes from the holes on both sides of width. Then the tubes and bag films are welded together at the point of the bag where the plastic tubes enter the bag and the second plastic tube leaves, so that the inside of the bag is still connected to the outside of the bag only through the first tube. From the center of the lower width side of the bag, two welded seams 50 are also joined together in the form of a V with an angle of 60 ° to the sides of length by thermal welding, with the result that the interior of the The bag has a conically decreasing section 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 so that its interior can be inserted only through the second tube, joins around the entire bag. The inside of the second sachet serves as a collection vessel for the recirculated used dialysis fluid.

<td colspan="3">First granulated material (half in each of</td>

<td>the first and second sachets):</td><td></td><td></td>

<td></td><td>NaCl:</td><td>166.78 g</td>

<td></td><td>NaHOOs:</td><td>190.34 g</td>

<td>Second granulated material:</td><td>NaCl:</td><td>166.78 g</td>

ES 2 725 007 T3 glucose X H2O: 68.20 g

Third granulated material:

Composition of the salt composition:

NaCl:

KCl:

CaCl2X2H2O:

MgCl2X6H2O:

Citric acid salt composition. 77.38

46.83% by weight

11.95% by weight

17.67% by weight

8.15% by weight

15.40% by weight

Comparison example 1:

A bag is produced substantially as in Example 1, except that none of the three sachets are formed, but the three granulated materials (first to third granulated materials 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 granulated material is introduced in the third bag and the third granulated material in the first bag.

Example 2:

A multilayer film of the type specified in example 1 is folded in half on its side of width with the external dimensions of 45 cm X 66 cm (given a bag size of 45 cm X 33 cm), with the result of 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 sides in length. At approximately 3 cm from the lower edge of one of the sides of width, a first granulated material (see example 1, the quantity and composition) is introduced into a first sachet forming a circular linear detachment seam (0 of approximately 10 cm ) between the two inner sides of the film by thermal welding, with the result that the granulated material is enclosed by the two opposite sides of the film and the detachment seam. The center of the first bag is approximately the same distance from both sides in length; The same also applies to the second and third bags. In the same way, a second granulated material (see example 1, the quantity and composition) is introduced into a second sachet at a distance of approximately 5 cm from the first seam detachment seam in the direction of the opposite width side . Again approximately 5 cm from the detachment seam of this second sachet in the direction of the side of opposite width, a third granulated material (see example 1 for quantity and composition) is introduced into a third sachet in the same way. The two halves of film are then welded together on the three remaining open sides, in which a first gap (approximately 3 cm) is left on the side of width opposite the first sachet in the center of the edge, in the case that the two halves of film do not weld together. Similarly, a second gap of approximately 2 cm is left on the opposite width side. A first 45 cm long plastic tube having a spray nozzle at the inner end is passed through this first hollow, into the bag. This end is located inside the bag. A second plastic tube is also passed through the inside of the bag but leaves in the gaps at both ends in equal parts. The tubes and bag films are then welded together at the points of the bag where the plastic tube (s) enters / exits (n) the bag, so that the inside of the bag Bag is still connected to the outside of the bag only through the first feeding tube. From the center of the lower width side of the bag, two welded seams are also joined together in the form of a V with an angle of 60 ° to the sides of length by thermal welding, with the result that the inside of the bag present an s conical decrease in the lower end (Figure 5 shows a bag according to example 1). A second bag measuring 48 cm X 34 cm, which is welded so that its interior can be introduced only through the second tube, joins around the entire bag. The inside of the second sachet serves as a collection vessel for the recirculated used dialysis fluid.

Example 3:

In Example 3, RO water is introduced into the bag at a rate of approximately 6 liters per minute through the bag feeding tube produced in Example 2. First, the first seam detachment seam is opened, by which gradually dissolves the first granulated material. Then, the detachment seam of the second sachet is loosened by the filling pressure produced by the fluid filling. Once the second granulated material has gradually dissolved in the RO water, it

ES 2 725 007 T3 opens the detachment seam of the third bag. Then the third granulated material gradually dissolves. After the addition of 60 liters of RO water, there is an almost transparent solution whose pH is 7.3. Only minor precipitation must be 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 clear that the mixed granulated material (first to third granulated material of the Example 1) It only dissolves sparingly. In addition, there is a bubbling that is identified as CO2. At the end of the addition, there is a cloudy solution that has a pH of 8.5. The precipitates contain CaCO3. The concentrate changes color and agglutinates. Therefore, storage stability is not guaranteed. 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 evident that the third and second granulated material dissolve well. After loosening the detachment seam of the third bag, the first granulated material is gradually added. Initially a bubbling begins. Bubbles are identified as CO2. Then the first two thirds of the first granulated material is completely dissolved. However, if the last third of the first granulated material enters the solution of the main chamber, it can be seen that the solution is slightly clouded initially. In the course of time, the cloudiness increases. At the end of the addition, there is a strongly cloudy mixture that has a pH of 8.6. The precipitates contain CaCOs.

In example 3 and comparison examples 3 and 4, the bags produced in example 1 and comparison examples 1 and 2 are filled with RO water within 2 hours after production. When the comparison example 4 is carried out, it is evident 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 could be observed in the granule formation capacity / powder formation capacity of the three granulated materials. After the addition of 60 liters of RO water as in example 3, the same result as in example 3 was achieved.

Comparison example 5:

The bag produced according to comparison example 2 was also stored for 3 weeks at a temperature of 40 ° C and a humidity of 75%. When 60 l of RO water was added as in comparison example 3, it was observed that the dissolution behavior of the mixed granulated material was greatly reduced. After the addition of 60 liters of RO water, a cloudy solution with a large amount of undissolved concentrate was produced.

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

A multilayer film of the type 1 film mentioned above 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 (given a bag size of 45 cm X 33 cm), which are joined together on their sides in length. Approximately with the dimensions shown in Figure 6, four chambers (3, 3a, 3b, 3c) are formed by welding the tear seam as shown in Figure 6, surrounding the concentrates (5, 5a, 5b, 5c) in the form of granules. The two halves of film are then welded together on the remaining three open sides, in which a gap (approximately 3 cm) is left on the side of width opposite the first sachet in the center of the edge and an additional gap in the side of width opposite this side of width at the edge, in case the two halves of film are not in each case welded together. A first plastic tube approximately 40 cm long is passed which has a spray nozzle at the inner end and ends inside the bag into the bag through this hole. A second plastic tube approximately 48 cm long is passed through the inside of the bag through both holes, with the result that it protrudes from the holes on both sides of width. Then the tubes and bag films are welded together at the point of the bag where the plastic tubes enter the bag and the second plastic tube leaves, so that the inside of the bag is still connected to the outside of the bag only through the first tube. From the center of the lower width side of the bag, two welded seams are also joined together in the form of a V with an angle of 60 ° to the sides of length by thermal welding, with the result that the inside of the bag It has a conically decreasing section at the lower end. A second bag measuring 48 cm X 34 cm, which is welded so that its interior can be inserted only through the second tube, joins around the entire bag. The inside of the second sachet serves as a collection vessel for the recirculated used dialysis fluid.

ES 2 725 007 T3

Concentrate (5): glucose (anhydrous): 62 g, resulting concentration: 5.55 mmol / l;

Concentrate (5a): MgCl2x6H2O: 6.3 g, resulting concentration: 0.5 mmol / l; CaCl2 (anhydrous): 8.62 g, resulting concentration: 1.25 mmol / l; KCl: 9.24 g, resulting concentration: 2 mmol / l; citric acid: 11.97 g, resulting concentration: 1 mmol / l;

Concentrates (5b, 5c): NaCl: 391.2 g, resulting concentration: 108 mmol / l; NaHCO3: 166.78 g, resulting concentration: 32 mmol / l

Example 6:

In Example 6, RO water is introduced into the bag at a rate of approximately 6 liters per minute through the bag feeding tube produced in Example 5. First, the detachment seams of the chambers (3 and 3a) at the same time, so that the concentrates (5 and 5a) gradually dissolve. Then, the detachment seams of the chambers (3b and 3c) are loosened by the filling pressure produced when filling with fluid. Then the concentrates gradually dissolve (5b and 5c). After the addition of approximately 60 to 62 liters of RO water, there is a completely transparent 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 opening the bags, the measured conductivity is approximately 0 mS / cm. When the second chamber (3a) of type B is opened, a change in the conductivity of the introduced fluid is measured. Since the shear seam strength of the shear seams 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 concentrates (5) and (5a) at the same time, it can be ensured that glucose dissolves in the fluid.

ES 2 725 007 T3