CONTAINER AND METHOD FOR THE PREPARATION OF A MEDICAL SOLUTION FROM SEVERAL CONCENTRATES

专利摘要:
container and method for preparing a medical solution from several concentrates the object of the present invention is a container with multiple chambers and a method for the preparation of medicinal fluids, compounds of concentrates that make a contribution to the electrical conductivity of the solution and also they are prepared from concentrates, which do not contribute to the electrical conductivity of the solution. the container by the fact that the components of the solution are divided into several chambers that are constructed so that, after dissolution, due to the breaking opening of the first edge of the chamber a component of the solution, which makes a contribution to the electrical conductivity of the medical solution, another edge of the chamber of another component of the solution, which does not contribute to the electrical conductivity of the solution, is opened by breaking.
公开号:BR112013024709B1
申请号:R112013024709-6
申请日:2012-04-12
公开日:2021-04-13
发明作者:Franz Kugelmann；Joern Hoermann
申请人:Fresenius Medical Care Deutschland Gmbh；
IPC主号:

专利说明:

The subject of the invention is a multi-chamber bag for maintaining concentrates and for producing a medical solution from the concentrates, as well as a method for producing a medical solution from several concentrates.
Patients with kidney failure suffer from limited kidney function impairment, so that the necessary excretion of substances bound to the patient's urine from the body is prevented. Toxic metabolites should be removed from the patient by purifying the blood in a dialysis treatment. In dialysis, blood is purified through a mass exchange membrane, which comes in contact with the patient's blood on one side and with a purification fluid on the other side. The purification liquid is the so-called dialysis solutions that hold certain substances, intended for secretion and remove them from the patient's blood. In general, dialysis solutions consist of an aqueous composition of physiologically important dissolved components, for example, electrolytes, buffers or osmotically active reagents, such as glucose, for example.
In peritoneal dialysis (PD), the dialysis solution is infused into the patient's peritoneum. The patient's diaphragm then functions as a mass exchange membrane through which the blood is purified. Mass transport is determined by processes of diffusion transport of substances bound to urine from the blood side across the diaphragm membrane and into the peritoneum, which is filled with the dialysis solution. An osmotic agent is added to the dialysis solution, so that a higher osmotic pressure prevails in the peritoneum than in the blood. Based on the osmotic pressure gradient, there is a transfer of water across the membrane to the peritoneal cavity. During the course of treatment, or at the end of treatment, the peritoneum is evacuated and the dialysis solution is discarded.
In hemodialysis (HD), the patient's blood to be purified is passed through an extracorporeal blood circulation and brought into contact with a mass exchange membrane. The opposite side of the mass exchange membrane is brought into contact with the dialysis solution, so that the penetrating substances in the membrane can be removed from the blood by means of membrane transfer, with the dialysis solution. The mass transfer process can occur through diffusion or convection transport processes in conventional HD therapies. It is possible to withdraw fluid from the patient by means of convective transport processes, in particular, so that, in general, a solution for HD should have a lower osmotic pressure for blood purification than solutions suitable for PD.
In both HD and TP, dialysis solutions contain typical dissolved substances, for example: • Na, K, Mg and Ca electrolytes, to maintain an acceptable electrolyte balance for the patient • buffers (eg, bicarbonate, acetate, lactate ) • glucose (or other osmotic agents), as an osmotic agent on peritoneal dialysis or to maintain blood sugar levels during hemodialysis • acids or acid salts (eg, HCl and / or Cl ", acetic acid , citric acid), which can contribute to the neutralization of basic solutions of partial dialysis or as counter ions of electrochemical balance.
The substances used for the dialysis solution cannot be stored in a mixture form ready for use in general, because these substances can cause mutual degradation. The necessary stability of a component in storage can presuppose storage conditions that lead to the degradation of other components. For example, depending on its concentration in solution, glucose can be stored at a certain acidic pH for long periods of time without being subjected to undesired degradation processes to an excessive extent. At the same time, sodium bicarbonate, which is often used as a buffer in dialysis solutions, is not stable when stored under acidic conditions, because bicarbonate tends to decompose as a function of pH and can release CO2. Under decomposition conditions, there are changes in the concentration of bicarbonate, which is unacceptable from a therapeutic point of view. The increase in the partial pressure of CO2 also makes medical dialysis equipment requirements, which leads to technical problems.
A variety of alternative compositions have known storage conditions and dosage forms for dialysis solutions or concentrates that allow for long-term storage. It is known that the components of the solution can be divided into a combination of partial or concentrated solutions, so that only compatible components of a partial solution or a partial concentrate are stored together. For peritoneal dialysis solutions, a first partial solution comprising glucose, which assumes the function of the osmotic agent, is conventionally stored at an acidic pH with additional electrolytes, for example, sodium, calcium, magnesium. Another partial base or buffered solution is necessary to provide a mixed solution that is physiological, that is, at least, ready to use for the treatment from the first part and in the second part, when using the first partial acid solution. The second part often consists of a solution or concentrate of sodium bicarbonate and sodium chloride. Partial or concentrated solutions are stored in several containers or in several chambers of a container. Partial solutions or partial concentrates are present separately, so that there is no mutual influence. Immediately before using the dialysis solution, the partial solutions or partial concentrates separately are mixed, possibly adding additional aqueous components, and are provided for treatment.
In hemodialysis, partial solutions or partial concentrates are often mixed in the dialysis machine, before and during the course of treatment and prepared to obtain a finished dialysis solution. Partial concentrates in solid or liquid form, which are present in individual containers, and are diluted by means of a connection to the dialysis machine with the help of a prepared hydraulic system are mixed and prepared for the ready-to-use finished dialysis solution.
Other developments in dialysis have a tendency to store the necessary concentrates in a single container. First of all, this simplifies the production and handling of the containers, and on the other hand, it also simplifies the hydraulic system of the dialysis machine because in the meantime only one receiver unit is needed for the partial solutions and fewer connections are needed to process the solution through the hydraulic system. This trend can be seen in acute dialysis, in particular, because mainly a greater mobility of the treatment system is necessary here.
In another variant, dialysis solutions for hemodialysis are not prepared from concentrates during the course of treatment, but instead the required total volume of dialysis solution is prepared in a one-step batch prior to treatment. The batch is kept in a reservoir, which is prepared to be connected to a dialysis machine. In many cases, the reservoir is an integral component of a dialysis treatment unit, or, in certain cases, it can also be removed again separately. Batch dialysis can thus have the advantage of selecting the treatment site relatively independently of the location by preparing the batch in one go. Treatment plants can thus be used in various positions, without having to rely on a dialysis solution preparation unit or a water connection, which supplies the water needed for the dilution of concentrates. In these cases, the dialysis solution is mixed from concentrates in a device designed for this purpose and is then stored, usually in a mobile reservoir.
It is known that the concentrates necessary for the preparation of a batch of dialysis solution can be kept in only one container unit. Thus, for example, dry granulated concentrates are known whose particles have a multilayered or multicomponent structure. Each layer of granules or each of the components contains the substances necessary for the preparation of the dialysis solution.
In another development, several dry concentrates are placed in a cylinder unit. Several granules, corresponding to different components of the solution, are poured into a container layer by layer. The components of one layer are thus presented essentially separately from the components of the next layer. Then, they are in contact with the components of the neighboring layers only through the interfaces between two neighboring layers.
However, in the analysis of these developments, it was found that negative interactions can occur between the various concentrates, even in the case of such a layered structure of a granular particle or in a concentrated dry layer presentation of corresponding solution components.
Dry concentrates make higher demands compared to partial solutions or partial concentrates of the type of solution in storage. The dry concentrates must not only overcome the degradation aspect of parts of the component solution concentrates during their guaranteed storage time, but must also be able to fulfill the aspect of good solubility in a diluent. Observations on the storage of dry concentrates from the state of the art have shown that concentrate particles can be subjected to agglomeration, under the influence of moisture. However, in an agglomerated state, the concentrate is not easily miscible with another aqueous diluent, so that the dissolution times of such concentrates may not be acceptable in clinical use. It is therefore required that concentrates, in particular dry concentrates, must be quickly and completely miscible with diluents or other solutions.
An all-purpose concentrate, containing all the ingredients needed for dialysis, is generally unstable in storage. The concentrate is therefore separated into partial concentrates, so that only those components of the solution that are compatible with each other and are storage stable are present in each partial concentrate. A set of concentrates or partial solutions prepared for the production of medical solutions can thus consist of two, three or more partial concentrates and / or partial solutions, which are stored in a container or bag. EP 1 458 433 discloses a concentrate container, in which the components of the solution or partial concentrates are layered and, therefore, mutually incompatible components are separated from each other. EP 1 059 083 discloses granules in which the grains have a layered structure. Mutually incompatible solution components can be kept separate from each other by layers of soluble buffer. WO 2007/144427 discloses a system for the production of dialysis solutions using a multi-chamber bag containing a partial concentrate in each chamber. The dividing lines between the chambers are broken by adding a fluid, and the dialysis solution is prepared. US 4,386,634 discloses a large volume container in which dry concentrates for the preparation of a dialysis solution are stored. A liquid concentrate is prepared by adding water. US 7,544,301 and EP 0 846 470 disclose methods for monitoring the solution process in preparing a batch of a dialysis solution based on electrical conductivity measurements.
It is described in the state of the art that several partial concentrates or partial solutions can be used for the preparation of dialysis solutions in a container with multiple compartments. Adequate storage stability cannot be achieved when storing the solution components, divided between several partial concentrates or partial solutions. Partial concentrates or partial solutions are stored in different containers or in different chambers of a container. The chambers are separated from each other by means of separation. Its contents are released by dissolving the separation media, obtaining a finished medical solution, ready to use by aqueous dilution or simple mixture, for example.
To monitor the process of preparing medical solutions, it is important to be clear about whether all partial concentrates have been mixed in the process. The partial concentrated solution and / or dilution process is easy to control, in general, by measuring electrical conductivity. If partial concentrates contain ionic substances, then they make a contribution to electrical conductivity when dissolved and / or diluted. At the end of the solution process, it can be indicated in particular to reach a final conductivity value in the solution / dilution process. It can thus be safely concluded that all parts of the partial concentrates or parts of solution have been mixed and no other partial concentrates or partial solutions are present in undissolved and / or unmixed form. Likewise, a conductivity value that does not correspond to a previously defined final conductivity value that indicates a partial concentrate or partial solution may not have been diluted and / or mixed. A control unit can thus be used in an action mode, so that an alarm or additional steps in the solution process are initiated, for example.
However, conductivity measurement may not provide enough information, if individual concentrates make only a very small or no contribution to conductivity. In the worst case, a final conductivity value can already be indicated in the solution production process, although the components of the solution, which make no contribution to electrical conductivity, are not dissolved, mixed or diluted. The components of the solution that are used for medical solutions and can make only a minor or none contribution to the electrical conductivity of a mixed aqueous solution, for example, organic substances, can include: • active ingredients, pharmaceutical drugs • in particular osmotic agents in the dialysis field: glucose, fructose, galactose, amino acids; acids: acetic acid, citric acid, lactic acid, succinic acid, fumaric acid, oxalic acid, malic acid.
In this technical context, the term "low electrical conductivity" is understood to refer to aqueous solutions with a conductivity value of 0.5 mS / cm or less. Or these compositions are, for example, concentrated, with or without diluents or partial solutions or suspensions, which cause a change in conductivity of 0.5 mS / cm or less, in a solution expected after dilution. In this sense, the organic acids mentioned above are also to be classified as substances that make their contribution to the low conductivity of the total solution, depending on the concentration.
There is, therefore, the problem of monitoring the solution process of multiple concentrates, solutions or partial solutions, through conductivity measurements, in such a way that at least one of the concentrates consists of substances, which do not make any contribution to conductivity. ready-to-use solution. Description of the Invention
The object of the present invention is to improve a medical method and a medical container, such that in the preparation of a medical solution from a diluent and a plurality of partial concentrates, at least a partial concentrate that makes little or no contribution to the conductivity, it is possible to plausibly conclude by determining a final conductivity value that all partial concentrates or partial solutions have been dissolved or mixed to prepare a ready-to-use solution.
This object is achieved by the subject of claim 1, a container for storage and preparation of a medical solution from a plurality of concentrates or partial solutions, as well as the method according to claim 23, for the preparation of a medical solution ready to use using the container according to the invention. Preferred embodiments are represented by the characteristics of the dependent claims.
Thus, in a solution process, according to the invention, a diluent is introduced into a filling chamber in a multi-chamber container. The container also includes a plurality of concentrate chambers that have partial concentrates for preparing the ready-to-use solution. In the course of filling, the concentrate chambers are opened by breaking and partial concentrates become mixed with the inlet flow of the diluent. A change in electrical conductivity that occurs during the solution process can be recorded by a suitable measuring device. Due to the arrangement of the concentrate chambers and inflow ports for the inlet diluent, and due to the selected geometry of the container, it can be a predetermined sequence for the release of the partial concentrates. The concentrate chamber holding a partial concentrate that makes little or no contribution to the electrical conductivity of the ready-to-use solution will be opened by breaking simultaneously with, or before, a concentrate chamber containing a partial concentrate that contributes to the electrical conductivity of the ready solution. to use. By monitoring the electrical conductivity of the solution preparation, which correlates with the release of the partial concentrates that make a contribution to the electrical conductivity of the ready-to-use solution, it is possible to monitor, through the release of the partial concentrates, those that do little or no contribution to the electrical conductivity of the ready-to-use solution.
Additional details and advantages of the invention will now be described in greater detail through the exemplary embodiments shown in the drawings, in which: Figure 1 shows a container according to the invention, which has three chambers, which contain the components of the solution. Figure 2 shows a bag container according to the invention, having six chambers containing components of the solution. Figure 3 shows a bag according to the invention, in the full state after all the dividing lines of the chamber have been separated. Figure 4 shows another embodiment of a container according to the invention having three chambers that contain components of the solution. Figure 5 shows another embodiment of a container according to the invention containing solution components. Figure 6 shows another container according to the invention having three chambers that contain components of the solution. Figure 7 shows a container according to the invention that has four chambers. Figure 8a schematically shows, in a lateral cross section, a container system according to the invention, comprising an inner bag having concentrate chambers and an outer bag, in which the first film of the inner bag has deep stretching zones. Figure 8b schematically shows, in a lateral cross section, a container system according to the invention, comprising an inner bag and an outer bag, in which the first film of the inner bag has deep stretching zones and the second film is not deeply stretched and in which the inner bag concentrate chambers are already open. Figure 8c schematically shows a container system according to the invention, comprising an inner bag and a closure bag, in which the walls of the film of the inner bag have opposite zones of deep stretching and in which the concentrated chambers of the inner bag are already open.
In the present invention, a multiple chamber container (1, 201, 401, 501, 601, 701) and a method for producing a medical solution, in particular, a dialysis solution are described. From partial concentrates (A, B, B, C, Ci, C2) or partial solutions, a ready-to-use medical solution is prepared by mixing partial solutions and / or by adding an aqueous diluent.
The container according to the invention has at least one filling chamber (10, 210, 410, 510, 610, 710) and at least two additional chambers (3, 4, 5, 203a, 203b, 204a, 204b, 205a, 205b, 403, 404, 405, 503, 504, 505, 603, 604, 605, 703a, 703b, 704, 705), which contain concentrates (A, Bi, B2, C, Ci, C2), partial concentrates or solutions that are incompatible with each other during storage. The chambers are hereinafter referred to as concentrate chambers, which is to be understood in the sense that they contain concentrates which provide the parties with to prepare ready-to-use medical solution by mixing with a diluent. A concentrate is understood in this context to refer to dry substances in the form of powders, tablets or granules. Likewise, the term "concentrate" also includes substances mixed with water, which may be in suspension or in emulsion, as a form of liquid concentrate or in aqueous solution.
The term "container" as used below is understood to refer to any type of hollow container made of flexibly rigid or flexible wall materials, also comprising bags, in particular.
In general, a bag is understood to include containers whose walls are made of a flexible material, which collapses under its own weight and thus are considered to be foldable containers. The collapse of a bag is considered to be an essential structural feature of the bag. In particular, bags can be filled with liquids or emptied without pressure equalization, due to the collapsible characteristics of the walls.
The term "container" also includes containers made of a semi-rigid wall material, which do not collapse under their own weight, but are deformable by hand.
The containers according to the invention (1, 201, 401, 501, 601, 701) or bags can consist of two opposite outer walls (2a, 2b, 202a, 202b, 402a, 402b, 502a, 502b, 602a, 602b, 702a, 702b), and can be manufactured from film materials, for example, by using welding tools or by other methods, for example, blow molding extrusion methods. Welds can circumscribe the outer contour or peripheral line (8, 208, 408, 508, 608, 708) of the container or bag in which, at least in some sections, you can thus define an interior space that has a predetermined volume capacity.
In a preferred form, the container (1, 201, 401, 501, 601, 701) is a multi-chamber bag made of flexible film sections (2a, 2b, 202a, 202b, 402a, 402b, 502a, 502b, 602a, 602b, 702a, 702b). A bag can also be understood to include a container designed so that the sections of the container comprise a flexibly rigid material, while other sections comprise a flexible film material. The container or bag according to the invention has lines (9, 9a, 9b, 209a, 209b, 209d, 209e, 209f, 409, 409a, 509, 509b, 609a, 609b, 609, 709a, 709b, 709c, 709d) , which subdivide the container into a plurality of chambers. The dividing lines preferably consist of welding lines or adhesive lines, which join the opposite sides of a container or bag from each other. Semi-permanent sections of the dividing lines are constructed in such a way that they are released by the application of force or pressure, without damaging the peripheral walls of the container. Likewise, when using flexibly rigid containers, the definition of semipermeable dividing lines also includes sections of material, which serve as break points intended for the application of force or pressure and which reveal a fluid transport passage between two compartments . Alternatively, other dividing lines having semi-permanent sections can also be used. These also include welding lines with so-called rupture connectors, which are released by manual force, welded inside. Likewise, sections of film welded as partitions can also form this dividing line and are in turn constructed so that they break when a force is applied. Alternatively, a dividing line is also understood to be a mechanism that joins the sections of film along a line by means of a clamping mechanism or folding mechanism and prevents unintentional mixing of the contents of the chamber.
The dividing lines (9, 9a, 9b, 209, 209b, 209d, 209e, 209f, 409, 409a, 509, 509b, 609a, 609b, 609, 709a, 709b, 709c, 709d) subdivide the multi-chamber container into at least at least one filling chamber and at least two concentrate chambers. At least a first chamber and a second chamber are divided by at least one first dividing line (9, 209a, 209d, 409, 509, 609, 709a, 709c) from the filling chamber (10, 210, 410, 510, 610,710). The first dividing line can consist of a permanent or semi-permanent dividing line in some sections, or it can be formed entirely by a semi-permanent dividing line. In particular, it can cooperate with a section of a permanent peripheral line of the container (8, 208, 408, 508, 608, 708). The concentrate chambers (3, 4, 5, 203a, 203b, 204a, 204b, 205a, 205b, 403, 404, 405, 503, 504, 505, 603, 604, 605, 703a, 703b, 704, 705) are delimited by the semi-permanent dividing line and sections of the permanent peripheral line (8, 208, 408, 508, 608, 708) and are delineated in relation to the filling chamber. In one embodiment, the concentrate chambers are completely surrounded by an edge line, which can consist of the peripheral line (408, 608) permanently in some sections or can be constituted by the first dividing line (409, 609) semipermanently.
Alternatively, the line from the first chamber (4, 204a, 204b, 504, 704, 705) around the concentrate chamber and the second chamber (3, 203a, 203b, 503, 703a, 703b) can be surrounded by a first semi-permanent dividing line (9, 209a, 209d, 509, 709a, 709c) in at least some sections without having cooperated with the peripheral line (8, 208, 508, 708) of the container. A first dividing line of the chambers then forms a closed line, which delimits with the first chamber, and a second compartment on the sides. In addition, the concentrate chambers are bounded by the outer walls (2a, 2b, 202a, 202b, 402a, 402b, 502a, 502b, 602a, 602b, 702a, 702b) of the container, so that the chambers are bounded by all sides.
A first dividing line (9, 209a, 209d, 409, 509, 609, 709a, 709c) can be designed to be completely semi-permanent in a section in which it delimits a first chamber (4, 204a, 204b, 504, 704, 705 ) and a second chamber (3, 203a, 203b, 503, 603, 703a, 703b). This generates the advantage that it releases or breaks the dividing line in this section by applying force eliminates the border between the two chambers and releases the contents of the chamber. In particular, it is such that an initial break in the semipermanent dividing line sections requires greater strength than another break in the dividing line, which has already been opened by breaking in one place. If there is a break in the first dividing line in a section bordering on a first chamber, then there is also a high probability that the section on the border of a second compartment will also be opened by breaking.
For the process for producing the medical solution in the container according to the invention, a feed port (6, 206, 406, 506, 606, 706) is provided, this feed port being cut on the peripheral line (8, 208 , 408, 508, 608, 708) of the container and, optionally, bringing the container filling chamber in fluid connection with an external fluid source.
With vertical storage of the bag, a dilution liquid, for example water or a partial solution, is first introduced into the filling chamber (10, 210, 410, 510, 610, 710) through a feed port. The hydrostatic pressure acting on the limiting planes (2a, 2b, 202a, 202b, 402a, 402b, 502a, 502b, 602a, 602b, 702a, 702b) inside the container, thus, increases due to filling and causes, at least the first dividing line (9, 209a, 209d, 509, 609, 709a, 709c) is opened. The contents of the first concentrate chamber (4, 204a, 204b, 504, 604, 704, 705) are mixed with the diluent inlet flow, or, alternatively, with a partial inlet flow solution. In the latter, through a greater filling of the container, the first dividing line is even more open, so that the contents of the second chamber (3, 203a, 203b, 405, 503, 603, 703a, 703b) come into contact with the inflow diluent / partial solution and mixed there. The opening of the first semi-permanent dividing line in at least some sections, which is caused by the accumulation of pressure, in turn, causes the opening of a first chamber and a second chamber, simultaneously or sequentially.
In one embodiment, the filling chamber can surround the closed concentrate chambers inside the bag, so that when the first and second concentrate chambers are broken, the concentrates go directly to the dilution chamber filled with diluent. The filling chamber is preferably in the initial state, that is, an empty chamber, which is in direct fluid connection with the supply port.
The semipermanent section of the dividing line is preferably designed so that the dividing line opens only by means of the hydrostatic pressure of the filling without the need for any further application of force.
It is, therefore, largely ensured that both chamber contents will come in contact with the inflow / partial solution diluent and be mixed to form a medical solution. Thus, it is also possible to determine, in large part, that the contents of the chamber of a first chamber containing the concentrates, which do not contribute to the electrical conductivity, are completely introduced into the solution when the process of solving the contents of the chamber of a second chamber containing the components that contribute to conductivity has been confirmed by conductivity measurements.
The container may also comprise another, that is, a third concentrate chamber (5, 205a, 205b, 403, 505, 605). This is particularly advantageous when the components of the solution have to be separated into at least three parts of concentrate, for reasons of stability. A third concentrate chamber can be provided in the container, so that a first concentrate chamber (4, 204a, 204b, 504, 604), a second concentrate chamber (3, 203a, 203b, 503, 603) and a third concentrate chamber (5, 205a, 205b, 505, 605) are surrounded by the first dividing line (9, 209a, 209d, 509, 609), or the chambers are surrounded in cooperation with the outer peripheral line (8, 208, 508, 608). The hydrostatic pressure that accumulates during the filling of the filling chamber causes the first dividing line, which is semi-permanent in at least some sections, to break, and causes the contents of the chambers (A, B, C, Ci, C2) of a first concentrate chamber, a second concentrate chamber and a third concentrate chamber to be released. The dissolution of a concentrate from one of the three chambers consisting of components of the solution, which makes no contribution to the electrical conductivity is then monitored by measuring the conductivity during the dilution / mixing process of the other chambers, which make a contribution to the Electric conductivity. The dividing line is semi-permanent in at least one area, which separates the three chambers from the filling chamber at the same time.
The container is preferably a bag, which is produced from film material. Sections can be produced from a flexibly rigid material. According to an alternative embodiment, a side wall of the bag is made of a flexibly firm material. The flexibly firm side wall transmits a support structure to the bag. The flexibly firm side wall can be an advantage in the case of bags with a large volume, in particular and can impart greater stability to the bag. The bag is preferably made of plastic materials, in particular thermoplastic plastic materials and thermoplastic elastomers. Preferred types of polymers include polyolefins and poly-alpha-olefins, as well as hydrogenated styrene block copolymers. In this context, the types of polymers, such as polypropylene, polyethylene, ethylene, propylene, butene, hexene or octene copolymers, styrene-isoprene-styrene (SIS) block copolymer, styrene-ethylene-butylene block copolymer (SEBS ), styrene-ethylene-propylene block copolymer (SEPS), and additional types are preferably used in this context.
If the container consists of a bag, there are advantages to the construction of the dividing lines. It is known that multiple chamber bags are manufactured by permanent boundary welds and peelable seams in an area dividing the chamber. Peeling seams in this context means the connection points of two joining partners, which have an adhesive effect on one another, due to a heat treatment. In the preferred case, the joining partners are two pieces of opposing films from a bag, which are joined together in the welding process using a welding bar by the action of heat and contact pressure. The temperature of the weld determines the force with which the peelable seam can be opened. A peelable seam is understood to be an adhesive bond, which can be released again by force, without resulting in a complete rupture of the film material.
In particular embodiments, the peelable bond can also be understood as a bond, which causes a partial delamination of a multilayered film composite, due to the action of the force. In such cases, it is important that the tear by delamination does not cause a complete rupture of the film material, which would render the bag useless.
In the present case, alternative embodiments for a first dividing line are provided in the multi-chamber bag according to the invention. In a first embodiment, the dividing line consists of peelable and therefore semi-permanent lines in some sections. The opening of the peeling seams due to the application of force or fluid pressure causes the contents of the chamber to be released and later mixed with the diluents or partial solutions flowing inwards. Permanent sections in the area of the dividing line connect the walls of the bag, even in a filled state. This can give stability to the bag because it reduces the burst pressure, which acts on the peripheral welds when the bag is full. In the case of bags with a large volume greater than 5 liters, in particular, this is important for the stability of the bag.
In another embodiment, the dividing lines are made entirely of peeling seams. By loosening the seams of the filling, the bag allows a good and complete mixture of all the contents of the chamber and simplifies the production of dividing lines from the point of view of production technology.
The peelable character of the dividing lines is influenced by the welding process. Depending on the temperature of the welding tool, detachable seams, which can be released, with a lower force can be produced. At a higher temperature of the welding tool, detachable seams with a higher resistance are obtained. Resistances of detachable seams are determined by known methods and standards. The resistance of the seam to peeling is conventionally determined by a T-peeling test in which two strips of test film are placed on top of each other and welded in the same section. The loose ends of the strips are attached to grips of a testing machine, so that the connection test strip describes a T. Then, a tensile test is performed on the film composite. The tensile test can be carried out in accordance with EN ISO 527-3. Likewise, the ATSM F 88-07 standard and the ASTM D 1876-01 standard describe methods for determining the resistance of the seam to peeling.
The peelable character of a dividing line produced at a defined temperature of the welding tool, the composition of the film layers, which are bonded to each other by heat treatment, is also important. A mixture of a thermoplastic polymer and an elastomeric polymer in particular, has been successful. An exemplary embodiment is a composition of 80% of a polypropylene (PP) thermoplastic and 20% of a hydrogenated styrene block copolymer, for example, a thermoplastic elastomer made of blocks of styrene and ethylene-butylene polymers ( SEBS). The heterophase mixture of polymers provides detachable welding lines at low temperatures and permanent welding lines, which can only be released by breaking the film at higher temperatures.
Different resistance from sewing to peeling may be necessary, depending on the specific application of a bag according to the invention. In one case, a multi-chambered bag according to the invention may be present with the liquid concentrate from one of the chambers, and the bag may be provided so that the peelable seams can be opened by applying external pressure. In such a case, pressure is applied to the liquid in a chamber by applying manual pressure or by rolling the bag, so that pressure breaks in the resulting fluid open the adjacent peelable seam. Such a bag generally requires greater resistance of the peelable seam because pressure can be applied to the liquid in a chamber even due to vibration during transport, so that the adjacent peelable seam can be damaged. In this case, the resistance of the peeling seam can be: • 2-20 N / 15 mm, preferably 2-15 N / 15 mm, preferably 2-10 N / 15 mm, 3-18 N / 15 mm, 2- 5 N / 15 mm
If these multi-chamber bags having solid concentrates in one or more of the individual chambers are used, there is no risk of accidental opening of the peeling seams because an external pressure due to granular or powder concentrates inside the chamber, for example, does not propagate and act on the dividing lines. In general, lower resistances of the peeling seam can be selected. In particular, there are applications for multi-chamber bags in which the peeling seams are released by an internal pressure of an inflowing liquid. The low resistance of the peeling seam is also advantageous in such cases, so that the concentrate chambers can be broken without any problem, and there is a complete mixing of the contents with the flow of the liquid that flows. In such applications, the following peeling seam strengths are advantageous: • 0.1-6 N / 15 mm, preferably 0.2-5 N / 15 mm, preferably 0.2-4 N / 15 mm, preferably 0.3-2 N / 15 mm.
For stability reasons, different partial concentrates can be stored in three concentrate chambers for the preparation of medical solutions. Likewise, the components of the medical solution solution can each be individually stored in a separate concentrate chamber. Thus, there may be a plurality of chambers that correspond to the number of solution components required. In addition, for reasons of preparing the solution, for example, the faster dissolution of several small concentrates, it may be advantageous to store the concentrate in more than two chambers.
According to the invention, at least two concentrate chambers are bounded by a first dividing line with respect to the filling chamber. Alternatively, at least three chambers can be bounded by a first dividing line with respect to the filling chamber. Alternatively, four chambers may also be delimited by a first dividing line with respect to the filling chamber. Five, six, seven or eight concentrate chambers can be optionally delimited by a first dividing line in relation to the filling chamber. A preferred embodiment is also one in which at least two, three or four of said concentrate chambers are surrounded by a first dividing line along the closed line and limited with respect to the filling chamber.
It is advantageous if at least two concentrate chambers (4, 204a, 204b, 404, 504, 604, 704, 705, 3, 203a, 203b, 405, 503, 603, 703a, 703b), which are bounded by a first dividing line (9, 209a, 209d, 509, 709a, 709c), with respect to the filling chamber, are separated from each other by a second dividing line (9b, 209g, 209f, 409a, 509b, 609b, 709b, 709d). The second dividing line can be in the form of a permanent weld or a semi-permanent weld or in embodiments of the bag it can be a peelable weld. In the first case, after the first dividing line is released, there is still a welding web forming the second dividing line that separates the chambers and can contribute to the stabilization of the filled bag. In the second case, the second peelable dividing line is also cut by the application of pressure, for example, the application of an external pressure or an internal pressure of filling, so that the film sheets in opposition to the bag are no longer connected one the other.
Alternatively, a first, second and third concentrate chamber (4, 204a, 204b, 504, 604, 3, 203a, 203b, 503, 603, 5, 205a, 205b, 505, 605) can also be delimited by a first dividing line with respect to the filling chamber, and a second dividing line (9b, 209g, 209f, 409a, 509b, 609b) can be present between the first chamber and the second chamber, and a third dividing line (9a, 209b, 209e, 509a, 609a) can be present between the second chamber and the third chamber.
The second and third dividing lines can each be permanent or semi-permanent and can be present as permanent or peelable welds in embodiments of the bag. In the preferred case, the first, second and third concentrate chambers are bounded by a first dividing line. And in the preferred case in particular, all dividing lines are semi-permanent dividing lines, in particular peeling seams.
Alternatively, in particular, in bag embodiments according to the invention having four or more concentrate chambers, additional dividing lines can be constructed such as the first dividing line to delimit additional concentrate chambers with respect to the filling chamber.
Concentrate chambers can contain concentrates, partial concentrates, liquid concentrates and / or partial solutions. Two or more concentrate chambers of at least four concentrate chambers can contain the same or different concentrates, partial concentrates, liquid concentrates and / or partial solutions.
In a preferred embodiment, the dividing lines, i.e. the first dividing line, the second dividing line, the third dividing line, etc., can be designed as peelable seams and integrally incorporated into the bag embodiments. In other words, the individual semi-permanent dividing lines do not start from one another, but instead overlap or become one another. Peelable seams are characterized by the fact that the force applied for a first initial tear in the peelable seam is greater than the force applied for the additional separation of a peelable seam from which it has already been torn. The integral construction of the sections of the first dividing line, the second dividing line, the third dividing line or additional dividing lines, such as a cohesive peeling seam design guarantees the opening of all these peeling sections, because it reduces the tear propagation resistance of a peeling seam partially peeled. If a section of the peelable sewing project has been partially peeled, it is possible to ensure that the complementary sections can be opened by applying less force.
In addition, the container according to the invention has a supply port (6, 206, 406, 5006, 606, 706) and / or a discharge port. The feed port allows a fluid, for example, an aqueous diluent to be added to the mixture of concentrates, partial concentrates, liquid concentrates and / or partial solutions to prepare a solution clinically usable by means of an external pump, for example example. If the container is a bag, then the bag unwinds due to the addition of the diluent. The internal hydrostatic pressure that builds up exerts a tensile force on the peelable seams through the film wall. By additional filling, the first dividing line, the second dividing line, the third dividing line, etc., are released successively according to the degree of filling and the hydrostatic pressure inside the bag and the contents of the chambers. In the remainder, of course, the contents of the chambers become mixed with the diluent that flows through the port entrance, so that a usable medical solution, preferably a dialysis solution, is obtained after the solution process. In another embodiment, the container has a discharge port with the help of which the solution thus prepared can be removed for further applications. It is preferably just a port that can be used for both filling and unloading. According to another embodiment, the discharge / filling port is designed as a length of tubing that passes through the outer walls of the container, for example, by means of a welding punch and leads into the bag. It is preferable for filling machine operations that the container is stored upright, for example, stored on a fixed integral rail (11, 211, 411, 511, 611, 711) and for the feed port tube to take to the bottom inside the container, so that the container is filled from the bottom. Alternatively, the feed port can also be attached to the container at the bottom when the container is stored upright and then the section of tube can protrude from the bottom into the bag to carry out the filling. bottom. Filling from the bottom is advantageous in vertical storage of the container, because turbulence can be produced by additional means (6c, 206c, 406c, 506c, 606C, 706c) in which the liquid flows in the container, and this turbulence promotes the mixing of the concentrates, partial concentrates, liquid concentrates and / or partial solutions.
The container advantageously has a filling chamber in which the feed port protrudes. The filling chamber is filled, and the dividing lines are released with an increase in the filling pressure, so that the contents of the concentrate chambers are mixed with an amount of liquid already present. This has the advantage that the contents of the concentrate chamber can be distributed immediately in the amount of liquid present in the filling chamber and the solution / mixing process is facilitated. The feed port at the end of the tube section preferably has means for creating turbulence of the flow within the container, thus promoting a complete mixing of the concentrates with the diluent.
In addition, it is advantageous that, in the embodiment as a bag, the container is made of an extensible elastic film material. The bag, therefore, increases its volume like a balloon, with an increase in the diluent filling. The film walls are stretched elastically, so that the stretch is reversed when the bag is emptied after using the medical solution, and the empty bag shrinks to the smallest possible size. This generates manipulation advantages for the nursing team, when using large volume bags with filling volumes of more than 60 liters. In addition, the use of stretch films results in a better filling of large volume bags, because the bag expands without folds as it fills and reduces, largely without folds, when empty. Completing the filling and emptying is therefore possible. In addition, the stretch film reduces the force expended to initiate the separation of peelable dividing lines. If too much force is applied to release the peeling seam, which is absorbed by stretching the film material and therefore counteracts possible breakage of the film and preserves the material. A film that is preferred for use for the production of a multi-chambered bag according to the invention is described in German Patent Application DE 10 2010 014 785.0, the contents of which are fully referenced here. It describes an elastically stretchable multilayer film, having at least one outer layer that is relatively thin in relation to the total thickness of the film, which is used for welding, and also having at least one relatively thick intermediate layer in relation to the total thickness of the film, this intermediate layer being essentially responsible for the mechanical behavior of the film, in particular, its elastic extensibility. The outer layer has two thermoplastic elastomers, one having a high melt flow behavior and the other having a low melt flow behavior. This optimizes the peeling of the peelable seams under elastic stretch of the film without weakening the seams too peelable for the intended effort and without overloading the film through the stretch.
In some cases, it may be convenient to take measures that allow for a uniform stretching of the material of the elastic extensively bag during the filling operation. In particular, when the concentrate chambers (fig. 8a) of the bag are formed by wall sections of the deep stretch film of only one of the two opposing films, uneven extension of the film material can occur when filling the bag. This can result in the side of the film, which is pre-weakened by deep drawing, being stretched to a greater degree than the side of the film which is not pre-weakened. Under these conditions, the bag may bulge due to filling, which can lead to several problems: • partially very high plastic deformation of the film and, therefore, a risk of tearing • restrictions on bag features, for example, cover and closure ventilation openings and additional access doors • folds of connecting tubes
The problem of weakening sections of film with deep stretching of a bag during filling can be solved with a bag that has the following characteristics: 1) Symmetrically expandable solution bag to receive fluids for renal replacement therapy, which consists of a first film and a second film, which are connected at the periphery, by a permanent boundary line and defines an internal space, which can be expanded by filling and stretching the films, in which the first film has areas of deep stretching, at least partially , to receive the concentrates and to form concentrate chambers and the second film is designed so that, when the enclosed space is filled with fluid, the first film and the second film are essentially stretched uniformly. 2) A bag that has the characteristics according to point 1), in which uniform stretching is achieved by the fact that the second film is designed to be thinner than the first film. 3) A bag that has the characteristics according to point 1) or 2), in which the second film is designed to be 2 to 20% thinner than the first film. 4) A bag that has the characteristics according to points 1) to 3), in which the second film is designed to be 5 μm to 20 μm thinner than the first film, especially when the first film has a thickness from 100 μm to 300 μm. 5) A bag with the characteristics according to point 1), in which the first film and the second film have areas of deep stretch in opposition.
All the characteristics of the models described here can be used for the design of such a bag. The permanent peripheral boundary line between the first film and the second film may consist of a weld if two individual films are welded together to form a bag. If a film tube is used, the boundary line is formed by a permanent weld in only a few sections. In other sections, the boundary line is formed by the film itself, and / or in a flattened shape of the bag, it is formed by a fold of the film.
To avoid asymmetric formation of the bag during filling, care must be taken to ensure that the films are subjected to the same elongation due to the hydrostatic pressure that develops. In particular, the thickness of the film and the modulus of elasticity of the film material have an influence on the elongation.
For uniform film elongation of the first film, which has deep stretch areas, and of the second film, which has no deep stretch areas, it is advantageous in one embodiment, if the second film is designed to be thinner than first film. The difference in the thickness of the films depends on the thickness of the film and the properties of the material (for example, modulus of elasticity). Therefore, it can be predicted that at a film thickness of the first film of 190 μm, the second film should be manufactured with a thickness of 180 μm, so that the films are stretched to the same extent with filling. The first film has a thickness of 190 μm in areas that are not deep-stretched (fig. 8b). In particular, uniform elongation of the first film and the second film can be achieved if the second film is designed to be 5 to 30 μm thinner than the first film in the non-stretched areas. This is to be used as the basis for bags with a filling volume of 5 to 120 liters, in particular.
Alternatively, it is possible to predict that the second film and the first film have deep stretch areas. The deep stretch areas of the first film and the second film are opposite each other. Stretching of the first film, due to the filling of the bag, causes an identical stretching of the second film, because the material thicknesses of the opposite film sections are always the same (fig. 8c).
The bag according to the invention is intended to be used in a system for the production of medical solutions, among other things. This system involves a device to produce and provide a ready-to-use dialysis solution in particular. The system comprises: • the multi-chamber container according to the invention having concentrates / partial solution for the production of a medical solution, in particular dialysis solutions; • a control unit to monitor the preparation of the liquid, preferably by measuring the electrical conductivity; • additional regulated and controlled pump media, which cooperate with the system and allow a dilution liquid to be added to the receiver system solution container; • additionally, a support structure, which is prepared to receive a multi-chambered container or bag according to the invention for the preparation of the medical solution.
To monitor the progress of the solution process, the system has the means to determine the electrical conductivity of a sample taken. However, means for continuously monitoring the conductivity of the mixing solution during the preparation process can also be provided. In one embodiment, the mixture solution prepared in the course of preparing the medical solution and analyzed by means of conductivity sensors can flow through a container or a section of the volume. The increase in the conductivity value during the preparation of the solution is detected by the conductivity sensors and transmitted to a control unit of a processor unit. A conductivity profile for preparing the solution from multiple partial concentrates / partial solutions can be stored in a memory unit. The type of solution container in the configuration of the partial concentrates can be inserted into an input unit and compared with the stored profiles. If the time values recorded over time correspond to the corresponding values stored in the memory unit in the course of preparing the medical solution in the solution container, then the solution is released for later use by the processor unit control unit. Otherwise, a signal can be generated by the control unit, indicating that the solution thus prepared is not released.
In addition, a method for producing a medical solution from multiple concentrates using a previously described multi-chamber container is also consistent with the object of the invention. According to this method, a liquid, for example, reverse osmosis (RO) water, or a partial solution is introduced into the filling chamber (10, 210, 410, 510, 610, 710) of the container (1, 201, 401, 501, 601, 701). During the filling operation, a first semi-permanent dividing line (9, 209a, 209d, 409, 509, 609, 709A, 709c) is broken due to the build up of the hydrostatic pressure of the introduced fluid, and the concentrate of a concentrate chamber (3 , 203a, 203b, 405, 503, 703a, 703b) is released and mixed with the liquid in the filling chamber. The released concentrate or concentrate from a concentrate chamber (4, 204a, 204b, 404, 504, 704, 705) broken in the remaining course of the filling operation essentially makes any contribution to the electrical conductivity of the solution to be prepared. Such components can be, for example, organic compounds that are soluble in aqueous systems, such as saccharides, oligosaccharides or polysaccharides, water-soluble polymeric substances or, for example, glucose, fructose, maltodextrin, icodextrin, inulins, etc.
Through additional filling, a first dividing line or other semi-permanent dividing line is then broken, and the concentrate (C, Ci, C2) from an additional concentrate chamber (3, 203a, 203b, 503, 703a, 703b) is released, making a contribution to the electrical conductivity of the solution. Such substances can be, in particular, the salts are present in dissociated form in mixture with the diluent, for example, sodium chlorides, magnesium chlorides, calcium chlorides, potassium chlorides, sodium phosphates, sodium citrates, lactates sodium, sodium carbonates, weak acid salts, for example, lactates, acetates, malic acid salts, fumarates, oxalates, succinates, carbonates or bicarbonates, or amino acid salts.
The release of a concentrate making a contribution to electrical conductivity and a concentrate without any electrical conductivity can take place simultaneously or with a time shift, but in any case, such that the concentrate (A, B) without any contribution or without any characteristic contribution to the electrical conductivity in solution it is not released and dissolved after the concentrate with a contribution to the electrical conductivity in solution (C, Ci, C2) • This method ensures that, by measuring the conductivity the dissolution of the concentrate with a contribution to electrical conductivity is monitored, based on the measurement of conductivity, so that the dissolution of the concentrate that does not contribute to electrical conductivity must already be completed or must occur simultaneously. With the help of this method and using the container described above, complete the dissolution of concentrates can be traced by conductivity measurements, in which certain concentrates do not contribute to electrical conductivity. The finished medical solution, for example, a dialysis solution, preferably has a specific electrical conductivity of 13.6 mS / cm. Specific conductivity values of 10 to 15 mS / cm, can be expected, in the direction of the material according to the invention, depending on the composition of the ready-to-use solution. Concentrates (A, B) that change the value of the specific electrical conductivity in solution only slightly, for example, 0.5 mS / cm or less, are considered to be unsuitable to allow monitoring of your solution process based on conductivity measurements. Especially in the preparation of high-volume material from the medical solution, for example, a supply of dialysis liquid from 60 to 120 liters, the possibility of errors in the preparation process cannot be excluded. The most accurate measurements possible, but it is not easily feasible in the context of preparing a ready-to-use solution from the concentrates because many parameters influence the solution process and, thus, the change in conductivity. Changes in conductivity of 0.5 mS / cm or less, for example, 0.3 mS / cm or less, or 0.1 mS / cm or less, cannot be considered to be a monitoring feature of the solution process, in the sense of the material according to the invention. Concentrates that still make such minor contributions to the conductivity of the ready-to-use solution are referred to in the sense of the matter according to the invention in the form of concentrates, which make no significant contribution to the electrical conductivity of a solution to be prepared.
Alternatively, pressure can also be applied to the bag externally and the required force can be applied to break the semi-permanent dividing lines. Here again, monitoring of electrical conductivity is preferably used to monitor the preparation of the medical solution.
In a preferred embodiment, a bag is used as the container for applying the method according to the invention. The bag may in particular be a large volume bag, which is to be understood as being a volume of 5 to 120 liters.
The advantage of using a bag for the method according to the invention is that the boundary dividing lines can be designed as releasable peelable seams. Peelable seams are easy to manufacture from the point of view of production technology, using plastic welding tools and specifying the sealing temperatures that are appropriate for the film material, so that there is no permanent welding of the film parts. The required peeling seam resistances are identical to the peeling seam resistances described for the multi-chamber bag.
Sequential rupture of the concentrate chambers during the filling operation can be influenced by different ways of realizing the resistances of the peeling seam. Thus, for example, a section of the peelable seam that limits a concentrate chamber containing concentrates that do not contribute to electrical conductivity in relation to the filling chamber may have a weaker strength of the peelable seam. The peelable seam section that separates the concentrate chamber containing concentrates that make a contribution to the electrical conductivity of the filling chamber can have a greater peelable seam strength. The concentrate that does not contribute to electrical conductivity is then released with less force than the concentrate that contributes to electrical conductivity. This meets the requirement, which is relevant in the filling process, that is, concentrates that make no contribution to electrical conductivity must be dissolved before or concomitantly having concentrates that make a contribution to electrical conductivity.
Preferred methods are those in which the pressure inside the bag acts by supplying the diluent to the inside of the bag. In this case, the diluent, for example, water, is supplied by a source of, for example, an RO (reverse osmosis) system. In one embodiment, the bag can be produced using dry concentrates and relatively weak peel-away seam lines. This is advantageous because the pressures to be applied to release the dividing lines can be kept low in this way. Therefore, the resistances of the film material used for the bag and lower film thicknesses can be selected, so that it saves materials and manufacturing costs.
In one embodiment, an external pumping means provides liquid, which is directed through a door into the bag. In the method according to the invention, the resulting internal filling pressure is built up via the external pump through the access port. With an increase in the pressure of the liquid inside the bag, the dividing lines are opened, and the contents of the chamber are released and mix with the inlet flow of the diluent.
The door is arranged over the bag and the diluent flows in it, in such a way as to open a first chamber. The contents of the chamber of the first chamber preferably include components that do not contribute to the electrical conductivity of the mixed solution. These can include, in particular, organic compounds, for example, glucose, fructose, sorbitol, osmotically active substances, such as water-soluble polymers, such as polyglycoses, polyfructoses and polyethers.
In the remainder of the bag filling process, another chamber is broken and the contents of the chamber are mixed with the diluent. The contents of the chamber are components that contribute to the electrical conductivity of the solution. In the case of dialysis solutions, these can be water-soluble salts, in particular, for example, sodium chloride, magnesium chloride, calcium chloride, sodium phosphates, potassium chloride, weak acid salts, for example, lactate sodium, sodium acetate, bicarbonate and / or sodium carbonate or sodium citrate. The conductivity sensor detects an increase in conductivity in the course of dissolving the components of this chamber. Depending on the design of the bag, a first chamber containing components that make no contribution to electrical conductivity is opened in the course of, that is, before or simultaneously with, that second chamber containing components that make a contribution to the electrical conductivity of the The solution for opening a first chamber is also ensured by changing the conductivity due to the dissolution of a second chamber. Detailed Description of the Invention With Reference to the Drawings
The following examples are embodiments that are consistent with the object of the invention, but the object of the invention is in no way limited by these examples. Within the scope of the description, it will be apparent to those skilled in the art that the invention can also be applied even beyond these exemplary embodiments.
In an embodiment of the container according to the invention for use in dialysis, multiple parts of the concentrate, which are stored in multiple chambers of the bag, are preferably used. The concentrates are preferably solid concentrates, but liquid concentrates or other forms of concentrate can be used as well with the bag according to the invention.
A preferred concentrate composition in a multi-chamber bag according to the invention for producing a ready-to-use dialysis solution is obtained from the following table. The preparation of multiple concentrates for the production of a dialysis solution is the subject of DE 102.010.039.489.0, the references of which are described here 10 made to the fullest extent.

Table 1
One or more components of the solution is divided into three concentrate chambers (A, B, C). Thus: • glucose is stored in compartment B without any other 5 substances • to magnesium carbonate salts, calcium chloride, sodium chloride, potassium chloride and citric acid are stored in the other compartment A • sodium chloride and sodium bicarbonate (optionally 10 potassium bicarbonate) are stored in another compartment C.
The components, which are preferably combined in a concentrate A, can induce a change in the electrical conductivity of the solution because these are salts dissociated in solution and, therefore, are cargo vehicles. However, although these substances are essential for a dialysis solution, they are present in an amount that is too small to allow a reliable conclusion on the state of the corresponding concentrate solution to be deduced from the measured values to monitor the preparation of the dialysis solution. dialysis. This concentrate A for the preparation of a dialysis solution must also be considered as a concentrate that, essentially, does not contribute to the electrical conductivity of the finished dialysis solution.
The components are divided into three parts of concentrate, for reasons of stability and storage. In general, it should be noted that no degradation of concentrates occurs during storage. It was found that solid concentrates of sodium bicarbonate, citric acid and glucose undergo unacceptable changes when stored together. Glucose degradation reactions occur. When mixed, the dry concentrate tends to absorb water from atmospheric moisture, resulting in agglomerates that cannot be dissolved quickly enough. The bicarbonate salts must be stored separately from glucose and separately from citric acid. Glucose must also be stored separately from citric acid. Likewise, sodium chloride must be stored separately from glucose. Dividing the concentrates results in storing the concentrates in at least three parts, and glucose must be stored in isolation and is therefore a partial concentrate that does not contribute to the electrical conductivity in solution. Additional preferred embodiments will be explained based on the figures. Figure 1 shows a container 1, which has a permanent peripheral boundary line 8. The container is preferably a bag and the peripheral boundary line is formed from a permanent weld. The bag consists of an outer upper wall 2a, seen from the perspective of figure 1, which is preferably produced from a sheet of film. In addition, the container or bag is shown from the perspective of figure 1, and is formed by another external wall 2b (not shown). The bag also has a concentrate chamber A having a concentrate 5, another concentrate chamber having a concentrate 4, and another concentrate chamber C having concentrate 3. The concentrate chamber is surrounded by a first dividing line 9, which is at less partially semi-permanent. The first concentrate chamber A is separated from the other concentrate chamber B by a second dividing line 9, which is semi-permanent in at least some sections. Concentrate chamber B is separated from the other concentrate chamber C by a third dividing line 9b, which is semi-permanent in at least some sections. All dividing lines 9, 9a, 9b are preferably designed to be semi-permanent in at least some sections, in an especially preferred embodiment, all dividing lines 9, 9a, 9b are completely semi-permanent. In addition, it is advantageous that the dividing lines are formed by peeling seams.
The bag also has a port 7 with a first end 7a outside the bag and a second end inside the bag. Another port 6 connects the inside of the bag to the other end 6a outside the bag through a first end inside the bag 6b. Port 6 is provided to communicate with additional fluid delivery means, for example, a pump. Doors 7 and 6 are preferably connected via welded connections to the circumferential boundary line 8 of a fluid-tight seal. Means 6c for generating turbulence in the fluid in the flowing diluent are preferably provided at the end 6b of port 6. Said means can be designed as a turbulence-generating nozzle or as a turbulence-generating frit.
In addition, the door 6 consists of a tube, which measures the longitudinal extent of the bag inside. Thus, it is ensured that when the bag is stored in an upright position during the filling operation, for example, the bag is filled from the bottom keeping the bag on a track 11 integrally fixed, and the concentrate chambers A, B, C are opened in order A, B, C, due to the internal pressure of the fluid.
In one embodiment, concentrate chamber A has a concentrate 5, which consists of calcium chloride, sodium chloride, potassium chloride and citric acid, making a minor contribution to the electrical conductivity in solution. Concentrate chamber B has a glucose concentrate 4, which does not contribute to the electrical conductivity in the solution. Concentrate chamber C contains a concentrate 3, which consists of sodium chloride and sodium bicarbonate and more optionally potassium bicarbonate, which makes a contribution to the electrical conductivity in the solution.
The bag also has an interior space 10, which represents a filling chamber and is preferably empty. In the preferred bag version of the container, the opposing film sheets 2a, 2b are pressed together by the diluent flowing into the filling chamber 10, so that with additional filling, a tensile stress is exerted on the dividing lines 9, 9a, 9b, which are released, so that partial concentrates 5, 4, 3 are mixed with the diluent. Figure 2 shows another diagram of a container 201, preferably a bag. The bag consists of an upper film sheet 202a, as seen from the perspective of figure 2, and a lower film sheet 202b (not shown). The bag also has a concentrate chamber A1 having concentrated 205a. According to the information presented in table 1, the Al concentrate chamber contains the substances of magnesium carbonate or soluble magnesium salts in general, calcium chloride or soluble potassium salts in general, citric acid or citrate salts. The concentrate 205a makes only a minor contribution to the electrical conductivity in the solution.
Another concentrate chamber B1 contains a concentrate 204a. In an exemplary embodiment, concentrate 204a consists of a glucose concentrate, which does not contribute to the electrical conductivity in the solution.
Another chamber of concentrate Cl with a concentrate 203a contains additional substances, which are incompatible with concentrates 205a, 204a, i.e., they tend to degrade or enter into undesirable interactions. The 203a concentrate contributes to the electrical conductivity in the solution. Concentrate 203a in particular is sodium chloride or sodium salts and sodium bicarbonate in general and carbonic acid salts in general.
The chambers are surrounded by a closed peripheral line, formed by a dividing line 209a, which has at least partially semi-permanent sections. The dividing line 209a preferably consists of a shell seam. The contents of the concentrate chambers Al, BI and Cl are separated from each other by the additional dividing lines 209B, 209C. Additional dividing lines 209B, 209C can be permanent weld lines, partially semi-permanent weld lines or shell seams. In a preferred embodiment, the shell seams 209A, 209B, 209C form an integral construction of sections of the peelable seam, which develop into one another and are completely released.
The exemplary embodiment of figure 2 is further characterized by a port 206 connecting the inside of bag 210 by means of a first end inside bag 206b and another outer end of bag 201. Port 206 is preferably connected by fluid-proof welded joints on the peripheral boundary lines 208. Means 206c for generating turbulence in the fluid in the inflating diluent are preferably provided at end 206b of port 206. Said means may be embodiments such as a turbulence-generating nozzle or as a turbulence-generating frit. In addition, port 206 is composed of piping that checks the longitudinal extent of the bag inside 210. This ensures that, in the filling process, for example, with vertical storage, the bag is held on an integral fixing rail 211 , the bag is filled from the bottom, and the concentrate chambers Al, BI and Cl are opened in sequence A, B, C, due to the internal filling pressure.
Another port 207 which has a first end 207a on the outside of the bag and another end 207b on the inside of the bag serves to remove or supply solutions, substances, drugs, etc.
In addition, the embodiment of figure 2 has a second set of compartments A2, B2, C2, which are enclosed by another dividing line along a second closed peripheral line 209d. Additional dividing lines 209e and 209f divide the contents of cameras A2, B2, C2. In a preferred embodiment, the peelable seams 209d, 209e, 209f form an integral construction of shell seam sections from which they develop into one another and are completely released.
In the exemplary embodiment, the contents of the A2 concentrate chamber consist of a concentrate 205b, which makes a small contribution to the electrical conductivity in solution. The concentrate 205b in the concentrate chamber A2 may be identical to the concentrate 25a or it may contain only a portion of the components of the concentrate 205a. In an exemplary embodiment, the components of solution 205b consist of magnesium carbonate or soluble magnesium salts, calcium chloride or soluble calcium salts, citric acid or citrate salts or other acid in general.
In an exemplary embodiment, another concentrate chamber B2 with solution components 204b contains substances that make no contribution to the electrical conductivity in solution. In an exemplary embodiment, which may include anhydrous glucose. Concentrate 204b may be identical to 204a or may contain other substances that make no contribution to electrical conductivity.
Another C2 concentrate chamber having concentrate 203b contains additional substances, which are incompatible with the substances in the components of the 205b solution, 204b, i.e., they tend to degrade or enter into an unwanted interaction. In addition, this concentrate in solution contributes to electrical conductivity. If the concentrate chamber C2 is ruptured and an increase in electrical conductivity due to the dissolution of concentrate 203b is detected, then concentrate 204b is definitely also dissolved. Substances in the components of the solution of elements 204b may be identical to substances 204a or may contain only a portion or additional substances 204a. In particular, the concentrate consists of sodium chloride or, in general, sodium salts, sodium bicarbonate or, in general, carbonic acid salts.
This embodiment also shows a peripheral line 208, which consists of a permanent weld. Additional permanent welding lines in the border sections 208a and 208b of the container contents or the contents of the bag, then the result is an inclined bottom of the bag. This construction facilitates the turbulence in the diluent inlet flow, due to the 206c means, which create the turbulence of the fluid and, therefore, facilitates the dissolution process of the components 205a, 205b, 204a, 204b, 203a, 203b. Figure 3 shows a lateral cross section of an embodiment in the full state. This view represents a particular embodiment, in which all the dividing lines are semi-permanent and have already been released, due to the filling. Fig. 4 shows another alternative embodiment 401. The container, preferably a bag, has an outer upper wall 402a, as seen from a perspective in Fig. 4, and an outer lower wall 402b (not shown), which in the preferred version comprises the top and bottom foil sheets of a bag. The bag also consists of concentrate chambers A, B, C with concentrates 405, 404, 403. According to table 1, concentrate 405 in chamber A can be identical to concentrates 205a, 205b, 5 of the forms previous achievements, 1, 201 and can make a minor contribution to the electrical conductivity in solution.
According to table 1, the concentrate 404 in the concentrate chamber B can be identical to the concentrate 204a, 204b, 4 of the previous embodiments, 1, 201 and makes no contribution to the electrical conductivity of the solution.
According to table 1, the concentrate 403 in the concentrate chamber of C can be identical to the concentrates 3, 203a, 203b of the previous embodiments, 1, 201 and can contribute to the electrical conductivity of the solution.
Concentrate chambers A and B are surrounded by a peripheral line 409 which is formed in the sections of a part of the peripheral line 408 and to the other part from a dividing line, which is at least partially semi-permanent. Preferably, the first dividing line of the peripheral line 409 consists of a shell seam and the sectional shapes of a margin 412 of one of the concentrate chambers A and B. The contents of the concentrate chambers A, B are separated from each other. by the second dividing line 409a.
The second dividing line 409a is semi-permanent at least in some sections, preferably it is a completely semi-permanent weld line, for example, a shell seam. In the preferred embodiment shown here, the sewing shells of dividing lines 409 and 409a form an integral construction of peeling seam sections that develop into one another, so that an incipient peeling seam breaks in the dividing line starting from 409 as well is propagated to the dividing line 409a.
A door 406 connects the inside 410 of the bag through a first end inside the bag 406b and another end 406a outside the bag 401. Door 406 is preferably connected by watertight welding connections on the peripheral dividing line 408. Means 406c for creating turbulence in the incoming diluent fluid is preferably provided at the end 406b of port 406. Said means can be designed as a turbulence-generating nozzle or as a turbulence-generating foot. In addition, port 406 consists of a tube that passes through the bag on the inside in its longitudinal extension. This ensures that the bag will be filled from the bottom in the filling operation, for example, in vertical storage, holding the bag on an integral 411 fixing rail, and the concentrate chambers A, B, C will be opened in order A, B, C , by the internal filling pressure.
Another port 407 which has a first end 407a on the outside of the bag and another end 407b on the inside of the bag serves to remove or supply solution, substances, drugs, etc. Figure 5 shows another alternative embodiment. This container, preferably a bag, has an outer top wall 502A in perspective in figure 5 and an outer bottom wall 502b (not shown) which in the preferred version, the top and bottom film sheets of a bag. The bag also consists of the concentrate chambers A, B, C with the concentrates 505, 504, 503. The concentrate 505 in the concentrate chamber according to table 1 can be identical to the concentrates 5, 205a, 205b of the embodiments previous, 1, 201 and can make a minor contribution to the electrical conductivity of the solution.
The concentrate 504 in the concentrate chamber B can be identical to the concentrates 4, 204a, 204b of the previous embodiments 1, 201 according to table 1 and may not make any contribution to the electrical conductivity of the solution.
The 503 concentrate in the concentrate chamber C can be identical having the concentrates 3, 203a, 203b of the previous embodiments 1, 201 according to table 1 and can contribute to the electrical conductivity of the solution.
Concentration chambers A and B are surrounded by a semi-permanent dividing line in at least some sections along a closed peripheral line 50 9. The dividing line is preferably made by a continuous seam shell. The contents of the concentrate chambers A, B, C are separated from each other by the additional dividing lines 509a, 509b. A first dividing line 509 borders the concentrate chambers B and C and surrounds chamber A. A second dividing line 509a separates the concentrate chambers A and B. An additional dividing line 509b separates the concentrate chambers B and C. The dividing line 409a it is semi-permanent in at least some sections and is preferably a completely semi-permanent weld line, for example, a peelable seam. Likewise, dividing line 509b preferably consists of a peelable seam. In the preferred embodiment illustrated here the seam shells of the dividing line 509 and 509b form an integral construction of peelable-seam sections that develop into one another, so that an incipient breakage of the peeling peel of the 509 dividing line is also propagated. for dividing line 509b.
A port 506 connects the inside of the bag through a first end inside the bag 506b and another outside end 506a of the bag 501. Port 506 is preferably connected in a fluid-tight form via solder connections on the peripheral dividing line 508. Means 506c for generating turbulence in the fluid in the entering diluent are preferably provided at the end 506b of port 506. Said means can be designed as a turbulence-generating nozzle or as a turbulence-generating frit. Port 506 preferably consists of a tube that passes through the bag on the inside in its longitudinal extension. This ensures that, in the filling process, with the bag in an upright position, for example, keeping the bag on an integral fixing rail 511, the bag is filled from the bottom and the concentrate chambers A, B, C are opened in order B, A, C, by the internal filling pressure.
When filling bag 501 through port 506 with the diluent, the diluent flows into the filling chamber 510. With an increase in the degree of filling, a tensile stress acts on the dividing line 509, resulting in the dividing line 509 being partially released and concentrate 504 being mixed with the diluent. As the filling continues, the concentrate chamber A is also opened releasing the dividing line 509A so that the concentrate 505 is mixed with the diluent and concentrate 504 which is already partially or completely dissolved. Concentrate 505 contributes to the electrical conductivity in the solution. By further filling the bag 501 the dividing line 509 and the dividing line 509b are completely dissolved, so that the concentrates are mixed with the diluent. The amounts of the solution components and diluents are such that a finished, physiologically acceptable solution, in particular, the dialysis solution is formed. Through changes in conductivity, which are attributable to the dissolution or dilution of the concentrates in the concentrate chamber A during the process of preparing the medical solution, it is possible to ensure that the peripheral dividing line 509 has been broken and the contents of the chamber B, which do not contribute for the conductivity of the solution to be prepared, they are released and dissolved.
Another port 507 having a first end 507a outside the bag and another inside end 507b to the bag serves to remove or supply solution, substances, drugs, etc. Figure 6 shows another embodiment. Container 601, preferably a bag, has an upper outer wall 602a in the perspective of Figure 6 and a lower outer wall 602b (not shown), which are bounded by a common peripheral edge 608 and are tightly connected to fluids . In a preferred version, 602a and 602b are the sheets of an upper and lower film of a bag. The bag also consists of the concentrate chambers A, B, C having concentrates 605, 604, 603. The concentrate in the concentrate chamber 605 A according to table 1 can be identical to the concentrates 5, 205a, 205b of the embodiments previous, 1, 201 and can make a minority contribution to the electrical conductivity of the solution.
A port 606 connects the inside 610 of the bag through a first end 606b in the filling chamber 610 of the bag and another end 606A outside the bag 601 to the outside of the bag. Port 606 is preferably watertightly connected to the peripheral dividing line 608 which is preferably a permanent weld. Means 606C for generating turbulence in the fluid in the incoming diluent are preferably provided at the end 606b of port 606. Said means can be designed as a turbulence-generating nozzle or as a turbulence-generating frit. Port 606 preferably consists of a tube that passes through the bag inside, in its longitudinal extension. Thus, it is ensured in the filling process that, when the bag is held in an upright position, for example, keeping the bag on an integral 611 fixing rail, the bag is filled from the bottom and the concentrate chambers A, B, C are opened by the internal filling pressure in the order B, A, C or A, B and C.
The chambers A, B, C are surrounded by a peripheral line 609, which is formed in the sections of a part of the peripheral line 608 of the bag and another part of a dividing line, which has at least partially semi-permanent sections. The first dividing line of peripheral line 609 preferably consists of a peelable seam and borders in a section of 612 two concentrate chambers. This ensures that a peelable section can release two concentrates to dissolve the peelable seam. The concentrate contents of chambers A, B, C are separated from each other by additional dividing lines 609a, 609b. Additional dividing line 609a is semi-permanent at least a few sections and is preferably a completely semi-permanent weld line, for example, a peelable seam. In a preferred embodiment shown here, the peelable seams of dividing lines 609, 609a, 609b form an integral construction of seam-shell sections, which develop into one another, so that a break in the incipient peeling seam of the 609 dividing line also is continued for dividing lines 609a and 609b.
According to table 1, the concentrate 604 in the concentrate chamber B can be identical to that of the concentrates 4, 204a, 204b of the previous embodiments, 1, 201 do not make any contribution to the electrical conductivity of the solution.
The concentrate 603 in the concentrate chamber C can be identical according to the table for the components of the solution 3, 203a, 203b of the previous embodiments, 1, 201 and can contribute to the electrical conductivity of the solution.
When filling bag 601 with the diluent through port 606, the diluent flows into a filling chamber 610. With an increase in the degree of filling, a tensile stress acts on the dividing line 609, resulting in the partial dissolution of the dividing line 609 , so that concentrate 604 alone or concentrate 605 at the same time becomes mixed with the diluent. As the filling continues, the concentrate chamber A also opens unless it is opened simultaneously with the chamber B according to the embodiment shown here, due to the dissolution of the dividing line 609a. Concentrate 605 preferably consists of substances that make a minor contribution to the electrical conductivity of the solution. In addition, filling the bag 601 causes the dividing line 609 to dissolve, and then the dividing line 609a, 609b dissolves completely, so that the concentrate 603 mixes with the diluent and concentrates 605 and 604. amounts of concentrates and diluents are such that a finished physiologically acceptable solution, in particular a dialysis solution, is formed.
Another port 607 which has a first end 607a on the outside of the bag and another end 607b on the inside of the bag serves to remove or supply solution, substances, drugs, etc. Figure 7 shows another embodiment as an embodiment according to figure 2. In the perspective of the drawing plane, the container has an outer upper wall 702a and an outer lower wall 702b (not shown), which are limited by a common peripheral edge 708 and are connected in a fluid-tight manner. In a preferred version, 702a and 702b are the top and bottom film sheets of a bag, and 708 is formed by a permanent weld.
The bag has a first concentrate chamber A having 705 concentrates, which in an exemplary embodiment consists of substances that contribute to the electrical conductivity in solution. According to the exemplary embodiments in Table 1, concentrate chamber A contains concentrate 705, magnesium carbonate substances or soluble magnesium salts, calcium salts, for example, dissolved or in solid form, magnesium chloride and / or calcium chloride, citric acid or citrate salts, acid or acid salts in solid or dissolved form in general.
In an exemplary embodiment, a second chamber of Cl concentrate having 703a concentrate contains substances that contribute to the electrical conductivity in solution.
In an exemplary embodiment, it can be sodium chloride and / or bicarbonate salts or soluble salts of carbonic acid, for example, sodium carbonate or other physiologically tolerable buffers, for example, weak acid salts in general.
Concentrate chambers A and Cl are surrounded by a dividing line 709a along a closed peripheral line, which consists of a semi-permanent dividing line in at least some sections in the embodiment shown here. In one embodiment, the first dividing line 709a consists of a peelable seam. The contents of the concentrate chambers A and Cl are separated from each other by the additional dividing lines 709b. Additional dividing lines 709b may consist of a permanent welding line, a partially semi-permanent welding line or a peelable seam. Dividing lines 709a and 709b are preferably designed as peelable seams and form a cohesive integral construction of shell-seam sections.
The exemplary embodiment according to figure 7 is also characterized by the fact that a connecting port 706 connects the filling chamber 710 of the bag to the outside of the bag through a first end inside the bag 706b and another end 706a outside of bag 701. Port 706 is preferably connected by welded joints on the peripheral dividing line 708 in a fluid-tight manner.
Means 706c for generating turbulence in the fluid in the incoming diluent are preferably provided at the 706b end of port 706. Said means can be designed as a fluid generating nozzle or as a generating turbulence frit. In addition, port 706 consists of a tube that passes through the bag inside, in its longitudinal extension. This ensures that, in the process of filling with the vertical storage of the bag, for example, keeping the bag on an upper fixing rail 712, the bag is filled from below and the concentrate chambers A, B, Cl and C2 are opened by pressure internal filling in order: A simultaneously with B, before Cl and simultaneously with C2.
Another port 707 which has a first outer end 707a of the bag and another end 707B serves to return spent medical fluid, preferably dialysis solution. Port 707 is designed as a tube inside the bag and is provided for passage through the bag along a longitudinal extension, when the bag is stored in a hanging position, for example, keeping the bag on the upper fixing rail 712. At location 711, tube 707 passes through peripheral line 708 in bag 701 and opens to another chamber (not shown). The location 711 can be a fluid seal weld that protects the bag between the upper and lower boundary planes 702a and 702b and is part of the welded peripheral line 708. The chamber (not shown) can preferably be a coating vessel. a bag, which can be an integral component of container 701. Thus, it produces a "bag in a bag" construction in which the bag containing the ready-to-use liquid is attached by a bag holding the spent liquid. Likewise, the chamber (not shown) can also be designed for separation.
In addition, the embodiment of figure 7 shows a second set of concentrate chambers B, C2, which are surrounded by another dividing line along a closed peripheral line 709c. Another dividing line 709d separates the contents of the concentrate chambers B and C2. In a preferred embodiment, the peelable seams 709c and 709d form an integral construction of peelable-seam sections, which develop into one another.
In the exemplary modality, the concentrate 704 in chamber B is composed of substances that do not make any contribution to the electrical conductivity in solution. In an exemplary embodiment according to table 1, this substance can be anhydrous glucose.
The concentrate 705 in the concentrate chamber A, can be identical to that of the concentrate chambers 205a in the embodiment of figure 2 or it can contain only some of the components 205a. In an exemplary embodiment, concentrate 705 consists of magnesium carbonate or soluble magnesium salts, calcium chloride or soluble potassium salts, citric acid or citrate salts in general, or another acid.
Another chamber of concentrate C2 having concentrate 703b contains additional substances, which are incompatible with the substances of concentrates 705, 704, i.e., they tend to degrade or enter into undesirable interactions. In addition, 703b concentrate in solution contributes to electrical conductivity. This ensures that with an increase in electrical conductivity due to the dissolution of components 703b, the dissolution of components 704 also occurs because the solution components in chambers B and C2 are limited and separated by a cohesive shell-stitching system that is being opened .
This embodiment also shows a peripheral line 708, preferably consisting of a permanent weld. Additional permanent solder lines, sections 708A and 708B, delimit the contents of the container or contents of the bag in such a way as to form an inclined bottom of the interior space. This concept promotes turbulence in the input diluent caused by means 706c, which creates fluid turbulence, thus facilitating the solution process of components 705, 704, 703a, 703b. Border lines 708c and 708d give more stability to the filled container, in particular, bag in the filled state. This is important for large volume containers, in particular, where the internal pressure, due to the quantities contained in the bag, can exert a load tension effect on the 708 peripheral line. Large volume bags, in this sense, should be understood as containers, with a volume of 5 to 120 liters or 40 to 80 liters, in particular 60 liters ± 15%. Figure 8a shows, schematically, in a lateral cross section of a container system according to the invention, having an inner bag (830A), which has concentrate chambers (831a) and an outer bag (833a), in which the first inner bag film has deep stretch areas (832a). Figure 8b shows schematically in a lateral cross section of a container system according to the invention, having an inner bag (830b) and an outer bag (833b), in which the first film (836b) of the inner bag has stretching areas deep (832b) and the second film (837b) has no deep stretch and in which the inner chamber concentrate chambers are already open. Figure 8b shows a state in which the concentrate chambers are present in an ideally open state. In other words, the dividing lines between the concentrate chambers have already been opened by filling the chambers with a diluent from the bottom side (835b). As the filling process continues, the first film (836b) and second film (837b) are stretched. The second film extends to the same extent as the first deep stretch film if the film is designed to be thinner accordingly. Figure 8c shows a container system according to the invention, consisting of an inner bag (831c), made of a first film (836C), with deep drawing areas (832b) and a second film (837c), having areas deep drawing (834c) and a wraparound bag (833c). The deep stretch areas of the two films are opposite each other. If the bag is filled from the bottom (835c), which leads to the stretching of the film material, both films are uniformly stretched. Therefore, when the bag is being filled, it does not have any unilateral lumps that could interfere with the function of the bag.

权利要求:
Claims (16)
[0001]
1. Container (1, 201, 401, 501, 601, 701) suitable for the preparation of medical solutions consisting of permanent exterior walls (2a, 2b, 202a, 202b, 402a, 402b, 502a, 502b, 702a, 702b) that define an internal capacity of the container, characterized by comprising • at least one filling chamber (10, 210, 510, 710), at least one first concentrate chamber (4, 204a, 204b, 504, 704, 705) and a second concentrate chamber (3, 203a, 203b, 503, 703a, 703b), which are arranged in an interior of the container, • in which the concentrate chambers (3, 4, 5, 203a, 203b, 204a, 204b, 503 , 504, 703a, 703b, 704, 705) are separated by dividing lines (9, 9a, 9b, 209a, 209b, 209d, 209e, 209f, 509, 509b, 709a, 709b, 709c, 709d), which are semi-permanent in at least some sections and are connected to the outer walls, • including at least one first dividing line (9, 209a, 209d, 409, 509, 609, 709a, 709c), which separates the filling chamber from a first design chamber ntrate and a second concentrate chamber, which does not interact with the peripheral line (8, 208, 208a, 208b, 508, 708) of the container and which surrounds at least the first concentrate chamber (4, 204a, 204b, 704 , 705) and the second concentrate chamber (3, 203a, 203b, 703a, 703b) along a closed line.
[0002]
2. Container (1, 201, 401, 501, 601, 701), according to claim 1, characterized by the fact that the filling chamber (10, 210, 410, 510, 610, 710) is connected with a feed port (6, 206, 406, 506, 606, 706) of the container (1, 201, 401, 501, 601, 701).
[0003]
3. Container (1, 201, 401, 501, 601, 701) according to claim 1 or 2, characterized in that the container comprises a third concentrate chamber, optionally a fourth concentrate chamber, optionally, a fifth concentrate chamber, optionally, a sixth concentrate chamber, optionally, a seventh concentrate chamber, optionally, an eighth concentrate chamber.
[0004]
4. Container (1, 201, 501) according to claim 3, characterized by the fact that the first dividing line involves a first concentrate chamber (4, 204a, 204b, 504), a second concentrate chamber ( 3, 203a, 203b, 503) and a third concentrate chamber (5, 205a, 205b, 505).
[0005]
5. Container (1, 201, 501, 701) according to any one of claims 1 to 4, characterized in that the container is a bag.
[0006]
6. Container (1, 201, 501, 701) according to any one of claims 1 to 5, characterized by the fact that the first dividing line (9, 209a, 209d, 409, 509, 609, 709a, 709c ) is a weld designed as a peelable seam in at least some sections or as a continuous peelable seam.
[0007]
7. Container (1, 201, 401, 501, 601, 701) according to claim 6, characterized by the fact that the peelable seam has a resistance of 0.1 to 8 N / 15 mm.
[0008]
Container according to claim 6 or 7, characterized in that a first concentrate chamber (4, 204a, 204b, 504, 704, 705) and a second concentrate chamber (3, 203a, 203b, 503 , 703a, 703b) are separated from each other by a second dividing line (9b, 209c, 209f, 509b, 709b, 709d).
[0009]
9. Container (1, 201, 401, 501, 601, 701) according to claim 8, characterized by the fact that a first dividing line (9, 209a, 209d, 409, 509, 609, 709a, 709c ) and a second dividing line (9b, 209c, 209f, 509b, 709b, 709d) are designed as an integral part of the construction of the peelable seam.
[0010]
10. Container (1, 201, 501) according to claim 4, characterized in that a second concentrate chamber and a third concentrate chamber are separated from each other by a third dividing line (9a, 209b, 209e, 509a).
[0011]
11. Container (1, 201) according to claim 4, characterized by the fact that the first dividing line (9, 209a, 209d, 609), the second dividing line (9b, 209C, 209f) and the third dividing lines (9a, 209b, 209e) are designed as an integral part of the construction of the peeling seam.
[0012]
12. Container (1, 201, 501, 701) according to any one of claims 1 to 11, characterized in that the container is manufactured from an elastically extensible film material.
[0013]
13. Container (1, 201, 501, 701) according to any one of claims 1 to 12, characterized in that the first concentrate chamber (4, 204a, 204b, 504, 704, 705) contains a concentrate (B), which makes no significant contribution to the electrical conductivity in solution.
[0014]
14. Container (1, 201, 501, 701) according to claim 13, characterized by the fact that the concentrate (B) of a first concentrate chamber (4, 204a, 204b, 504, 704, 705) that makes no significant contribution to electrical conductivity comprises glucose.
[0015]
15. Container (1, 201, 501, 701) according to any one of claims 1 to 14, characterized in that the second concentrate chamber (3, 203a, 203b, 403, 503, 603, 703a, 703b ) contains a concentrate (C, C1, C2) that makes a contribution to the electrical conductivity in solution.
[0016]
16. Method for preparing a medical solution from several concentrates (A, B, B1, B2, C, C1, C2), using a container as defined in any one of claims 1 to 15, characterized in that it comprises the steps of: • introduce liquid into a filling chamber (10, 210, 410, 510, 610, 710) of the container (1, 201, 401, 501, 601, 701), • break a semi-permanent dividing line (9, 209a, 209d , 409, 509, 609, 709a, 709c), which delimits with the first concentrate chamber (4, 204a, 204b, 404, 504, 604, 704, 705), due to the development of hydrostatic pressure, • release the concentrates ( A, B, B1, B2), which make essentially no contribution to the electrical conductivity of the solution, • additional filling and application of pressure and open rupture of the dividing line (9, 209a, 209d, 509, 609, 709a, 709c ) or another dividing line (409b) that delimits another concentrate chamber (3, 203a, 203b, 403, 503, 603, 703a, 703b), at the same time or with a deviation time, • release the concentrate (C, C1, C2) from an additional concentrate chamber that contributes to the electrical conductivity of the solution.

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引用文献:

---

公开号 | 申请日 | 公开日 | 申请人 | 专利标题

---

---

US4386634A|1980-10-10|1983-06-07|Renal Systems, Inc.|Proportioning system|

---

DE4139165C2|1991-11-28|1994-12-08|Fresenius Ag|Device for the production of a medical fluid|

---

US5932110A|1995-02-13|1999-08-03|Aksys, Ltd.|Dialysate conductivity adjustment in a batch dialysate preparation system|

---

DE19605357A1|1996-02-14|1997-08-21|Braun Melsungen Ag|Flexible plastic container|

---

FR2766797B1|1997-07-30|1999-09-17|Smad|PACKAGING FOR AT LEAST ONE SOLID MATERIAL, ESPECIALLY IN GRANULAR OR POWDERY FORM|

---

DE19751489A1|1997-11-20|1999-05-27|Nutrichem Diaet & Pharma Gmbh|Double bag for application of a fluid substance|

---

DE19809945C2|1998-03-07|2002-02-21|Fresenius Medical Care De Gmbh|Device for providing dialysis fluid with a device for monitoring selected parameters of the dialysis fluid and method for monitoring selected parameters of the dialysis fluid during a dialysis treatment|

---

WO2000057833A1|1999-03-25|2000-10-05|Gambro Lundia Ab|Method and supply bag for providing a medical solution|

---

EP1059083B1|1999-06-07|2004-04-14|Nipro Corporation|A solid pharmaceutical preparation for dialysis and a process for producing the same|

---

DE10162959B4|2001-12-20|2017-10-12|Fresenius Medical Care Deutschland Gmbh|Container containing at least two solids and its use|

---

JP4581331B2|2003-03-25|2010-11-17|味の素株式会社|Drug-filled multi-chamber bag|

---

EP1621177A1|2004-07-29|2006-02-01|Fresenius Kabi Deutschland GmbH|Medical container with improved peelable seal|

---

US7544301B2|2004-08-19|2009-06-09|Hhd Llc|Citrate-based dialysate chemical formulations|

---

JP4656302B2|2005-03-25|2011-03-23|藤森工業株式会社|Multi-chamber container|

---

US8343129B2|2006-06-15|2013-01-01|Metpro Ab|Container, system and method for providing a solution|

---

JP5100308B2|2006-10-27|2012-12-19|株式会社大塚製薬工場|Chemical container with reduced dissolved oxygen content|

---

JP5237296B2|2006-12-07|2013-07-17|ガンブロ・ルンディア・エービー|Multi-chamber container|

---

AU2008341350B2|2007-12-24|2012-06-07|Choongwae Corporation|Multilayer film for medical solution container and a container comprising the same|

---

US20090166363A1|2007-12-27|2009-07-02|Baxter International Inc.|Multi-chambered containers|

---

DE102010014785A1|2010-04-13|2011-10-13|Fresenius Medical Care Deutschland Gmbh|Multilayer film, use of a multilayer film and method for producing a multilayer film|

---

DE102010039489A1|2010-08-18|2012-02-23|Fresenius Medical Care Deutschland Gmbh|concentrate|DE102011011883B4|2011-02-21|2015-09-03|Scaldopack Sprl.|Packaging for a liquid product and method and device for its production|

---

EP3542840A1|2011-03-23|2019-09-25|NxStage Medical Inc.|Peritoneal dialysis systems, devices, and methods|

---

US9861733B2|2012-03-23|2018-01-09|Nxstage Medical Inc.|Peritoneal dialysis systems, devices, and methods|

---

WO2012150632A1|2011-05-02|2012-11-08|株式会社モリモト医薬|Dosing container|

---

DE102011106248A1|2011-07-01|2013-01-03|Fresenius Medical Care Deutschland Gmbh|Container, use, dialysis machine or preparation unit and method for producing a concentrate|

---

FR2978914B1|2011-08-11|2013-08-16|Fresenius Medical Care De Gmbh|CONTAINER FOR DIALYSIS|

---

DE102012007697A1|2012-04-19|2015-08-13|Fresenius Medical Care Deutschland Gmbh|Bag with flow compensation|

---

WO2014179536A1|2013-05-02|2014-11-06|Ugarte Roland Rene M D|A catheter collection and drainage device and system|

---

ITBO20130266A1|2013-05-28|2014-11-29|Bellco Srl|BAG CONTAINING POWDERED BICARBONATE|

---

ITBO20130267A1|2013-05-28|2014-11-29|Bellco Srl|METHOD TO PRODUCE A BAG CONTAINING POWDERED BICARBONATE|

---

DE102013108082A1|2013-07-29|2015-01-29|B. Braun Avitum Ag|Device for producing a solution, in particular in / on a dialysis machine|

---

DE202014104252U1|2014-09-09|2015-12-11|Nephtec Gmbh|Container for the production of dialysis concentrates|

---

JP6931266B2|2014-10-23|2021-09-01|ニプロ株式会社|Dialysis agent filler|

---

US10828412B2|2016-05-06|2020-11-10|Gambro Lundia Ab|Systems and methods for peritoneal dialysis having point of use dialysis fluid preparation including mixing and heating therefore|

---

CN111432857A|2017-05-05|2020-07-17|费森尤斯医疗护理德国有限责任公司|Peritoneal dialysis concentrate, peritoneal dialysis bag and kit for continuous ambulatory peritoneal dialysis or automated peritoneal dialysis|

---

US11110213B2|2017-11-01|2021-09-07|Gambro Lundia Ab|Mixing for online medical fluid generation|

---

US20190262525A1|2018-02-28|2019-08-29|Nxstage Medical, Inc.|Fluid Preparation and Treatment Devices Methods and Systems|

---

USD900311S1|2018-05-18|2020-10-27|Baxter International Inc.|Dual chamber flexible container|

---

DE102018121675A1|2018-09-05|2020-03-05|Fresenius Medical Care Deutschland Gmbh|Container arrangement, method for filling a container arrangement and use of a solution as a dialysis solution|

---

DE102018121688A1|2018-09-05|2020-03-05|Fresenius Medical Care Deutschland Gmbh|Container, method for filling a container and using a solution as a dialysis solution|

---

FR3089126B1|2018-11-30|2020-12-18|Fresenius Medical Care Deutschland Gmbh|Pocket for solid concentrate|

法律状态:
2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-10-01| B15K| Others concerning applications: alteration of classification|Free format text: AS CLASSIFICACOES ANTERIORES ERAM: A61M 1/16 , A61J 1/20 Ipc: A61J 1/20 (1990.01), A61M 1/16 (1985.01), A61J 1/1 |

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2019-10-08| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-12-08| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|

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2021-02-09| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-04-13| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 12/04/2012, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US201161475405P| true| 2011-04-14|2011-04-14|

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DE201110017048|DE102011017048A1|2011-04-14|2011-04-14|Multi-chamber container for the production of medical solutions|

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DE102011017048.0|2011-04-14|

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US61/475,405|2011-04-14|

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PCT/EP2012/001578|WO2012139753A1|2011-04-14|2012-04-12|Multi-chamber container for producing medical solutions|

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