• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    CONTAINER, USE, DIALYZER OR PREPARATION UNIT, AS WELL AS A METHOD OF MANUFACTURING A CONCENTRATE The present invention relates to a container that comprises at least one dry concentrate, in which the dry concentrate is designed so that it forms at least at least, an acidic liquid concentrate, or a part of an acidic liquid concentrate, which is suitable for manufacturing at least in dialysis solution, in its dissolution in a liquid, preferably in water.
    公开号:BR112013033758B1
    申请号:R112013033758-3
    申请日:2012-06-29
    公开日:2021-03-02
    发明作者:Gerhard Wiesen；Peter Kloffel；François Dumont D'Ayot；Philippe Laffay；Benoit Luaire
    申请人:Fresenius Medical Care Deutschland Gmbh；
    IPC主号:
    专利说明:

    [0001] The present invention relates to a container that comprises at least one dry concentrate.
    [0002] A base concentrate that is generally present as a dry concentrate consisting of or comprising bicarbonate is normally used as part of carrying out a dialysis treatment, in particular, a hemodialysis treatment. This concentrate is located, for example, in a container, such as a bag or a cartridge that is attached to the dialyzer. A saturated solution consisting of or comprising bicarbonate is then made from this dry concentrate by supplying ultrapure water. This base concentrate can be introduced outside the container and used for the manufacture of the actual dialysis solution, with the result that it is possible to start the introduction of the concentrate when the solid dry concentrate is still located in the container.
    [0003] A so-called acid concentrate is generally used in the manufacture of a dialysis solution in addition to the so-called base concentrate. It comprises a solution of a plurality of components that are usually present in different amounts and / or concentrations. Typical components are NaCl, as the main component, and the other electrolytes, such as CaCl2 and MgCl2, in smaller amounts. The specifications for the electrolyte concentrations are very tight, which means that all components of the acid concentrate must be completely dissolved before using the acid concentrate in the dosage or dosage unit to manufacture the dialysis solution. This cannot occur in flow as with the base concentrate. It is rather the case that a special mixing apparatus, such as agitators, has to be used here to guarantee this complete dissolution in an acceptable period of time.
    [0004] In this context, the so-called acid concentrate is generally supplied as a liquid concentrate in a container from which the liquid concentrate is removed by means of the dialyzer or a preparation unit and is used to manufacture the dialysis solution. finished. A disadvantage in using such containers is the relatively complex handling, as well as the relatively high weight, which brings disadvantages with regard to transport costs and storage costs.
    [0005] In clinics where a greater number of treatment plants are present, lines are sometimes also used to which they are connected to a central supply unit. The acidic liquid concentrate is manufactured or made available with the aid of a special mixing device in this central supply unit and is then introduced into the line. It is introduced from the line to dialyzers or treatment plants and is then made available to the dialyzer to prepare the ready-to-use dialysis solution.
    [0006] A disadvantage of this procedure is that the disinfection and cleaning of such a system is laborious, expensive and polluting and, in addition, that this type of supply of concentrate is only economical for larger treatment centers, due to the relatively high costs.
    [0007] It is the underlying objective of the present invention, to provide a possibility of supplying an acid concentrate that is associated with reduced costs and that can be carried out with simplicity.
    [0008] This objective is met by a container that has the characteristics of claim 1.
    [0009] The delivery is therefore made that the dry concentrate located in the container is designed so that in its solution in a liquid, preferably in water, an acidic liquid concentrate or a portion of a liquid concentrate is formed acid that is suitable for making a dialysis solution.
    This is, therefore, the underlying idea of the present invention to provide the acidic liquid concentrate by dissolving a dry acidic concentrate located in a container, for example, in a bag or cartridge. The transport of heavy containers to the dialyzer, as well as the supply of complex line systems, can thus be avoided. This is sufficient to securely connect the container according to the present invention to the dialyzer or to a preparation unit, preferably local, which is preferably located in spatial proximity to the dialyzer, and then to manufacture the concentrate acidic liquid in place, that is, in the treatment plant, by dissolving the so-called dry concentrate.
    [0011] The present invention therefore relates to the manufacture of the acid concentrate normally used in the context of dialysis treatment and the manufacture of the ready-to-use dialysis solution. This acidic liquid concentrate preferably comprises the Na +, Ca2 +, Mg2 +, K +, Cl- ions and, optionally, other ions and additives, such as one or more acids, buffers, acetates, glucose, etc.
    [0012] If a preparation unit is used, it is preferably not located in a central location, but is instead accommodated locally, for example, in or near the dialyzer or treatment plant. It is conceivable that such a preparation unit is provided by dialyzer.
    [0013] It is thus possible, in accordance with the invention, in a similar manner also for the base concentrate, to present the dry acid concentrate in a disposable container or in another container, preferably fixedly connected to the dialyzer or to a unit of preparation. It is conceivable that the container has one or more connection elements that are connectable, preferably detachable, to one or more means of coupling the dialyzer or the preparation unit via a plug-in connection or otherwise and regardless of the connection type. The connection between the receptacle and the dialyzer or the preparation unit is preferably made as fluid-proof and detachable, so that the container can be removed again after use and can be replaced by a new container filled with the concentrate. dry.
    [0014] The dry concentrate can then, for example, be brought to dissolution by the device already present in the dialyzer or in the preparation unit, such as air pumps and compressors, and then can be used directly to manufacture the solution ready for use dialysis.
    Alternatively or in addition to this, local mixing units, preferably smaller mixing units, can also be used, which are also called preparation units within the scope of the present invention and for which the concentrate receptacle, i.e. that is, the container according to the invention, can be connected. Dissolution of the concentrated acid occurs therein, in which the acidic liquid concentrate is produced which can then be supplied in a manner suitable for the dialyzer or can be used to manufacture the finished dialysis solution.
    [0016] The container according to the invention is designed so that it has connection means, by means of which the container can be coupled to a dialyzer or to a preparation unit. These connection means can be designed in such a way as to ensure a secure attachment of the container to the dialyzer or the preparation unit using coupling means of the dialyser or the preparation unit. The coupling can be formed so that it is liquid-proof and / or gas-proof.
    [0017] The connection means and the coupling means can be formed so that the container can be accommodated in the dialyzer or in the preparation unit by a plug-in connection. It is also possible to make the connection means for the container and the coupling means in the dialyzer or in the preparation unit, so that the coupling is carried out by a rotational movement, or through a pivot movement of the container, optionally comparable with a bayonet clasp.
    [0018] The connection means of the container according to the invention can, for example, cooperate or communicate with coupling means of the dialyzer or another preparation unit in such a way that, on the one hand, a connection region is established between the coupling means and the connection means through which the medium used for dissolving the dry concentrate, in particular liquid, preferably water and, in addition, gas, preferably air, is introduced. This introduced liquid or the introduced water, as well as the introduced air or gas, can then be introduced into a lower region of the container starting from the container connection means through a flexible tube, through a passage, through a tube , etc. The finished liquid concentrate can also preferably be removed from the receptacle via this coupling point.
    [0019] The connection means and the coupling means can, in addition, form a second connection region through which a fluid, in particular a gas, and particularly preferably air, is removed from the container.
    [0020] In a preferred embodiment of the invention, not only water, but also air is introduced through the receptacle connection means and through the dialyzer coupling means or the preparation means or through a corresponding fluid connection of these means, and still, preferably through a flexible tube or the like in the container, with the purpose of dissolving the dry concentrate.
    [0021] As soon as this air can escape, the connection means and the coupling means have a second connection region that forms a second fluid connection between the receptacle and the dialyzer or the preparation unit and through which the air can it may be introduced into the container, for example, into the atmosphere or into the dialyzer or into the preparation unit and may be carried out of the container, for example, into the atmosphere.
    [0022] An exemplary embodiment for the means of connecting the container, on the one hand, and for coupling means of the dialyzer or a preparation unit, on the other hand, can be found in EP 1 344 550 B1 which is it makes reference here in full and, whose content of disclosure is thus made the object of the present invention. As can be seen from this document, the connection means of the container each have connecting parts, which can each be coupled to a part of the corresponding connector of the coupling means. These parts of the connector each have a passage through which, according to the present invention, air and the solution medium for dissolving the dry concentrate, in particular water, flow and then move to inside the container.
    [0023] The other part of the connector of the connection medium also has an opening or a passage that serves to introduce air out of the container during the dissolution process.
    [0024] Departing from the teachings of EP 1 344 550 B1, the supply is preferably made within the scope of the present invention that a part of the connector serves for the supply of air and solvent, in particular water, as well as also for the removal of the liquid concentrate. The other connector serves, within the scope of the present invention, only for the removal of gas or air from the container.
    [0025] The so-called dry concentrate located in the container can, for example, comprise NaCl and / or CaCl2 and / or MgCl2 and / or KCl and / or other electrolyte salts and / or citric acid and / or one or more other acids and / or glucose and / or acetate or other ions, or it may consist of one or more of these substances.
    [0026] As another embodiment or aspect of the invention, it is possible that the container has a volume such that, in addition to the dry, liquid concentrate, preferably water, it can be received or is received in a volume of 2 to 15 liters or from 4 to 15 liters, preferably in a volume of 4 to 15 liters, to manufacture the acidic liquid concentrate by dissolving the dry concentrate and / or that the container has a total volume in the range of 4 to 15 liters.
    [0027] It is in particular conceivable that the dry concentrate is contained in the container in such an amount that its dissolution in a volume of 4 to 15 liters of liquid, preferably water, a resulting liquid concentrate, with the dry concentrate, preferably being completely dissolved. This is diluted to manufacture the finished dialysis solution so that the substances are present, preferably, in the following concentration ranges with respect to the volume of the finished dialysis solution: NaCl: 110-170 mmol / L, preferably 130-150 mmol / L KCl: 0.7-4.3 mmol / L, preferably 1.0-4.0 mmol / L CaCl2: 0.7-2.0 mmol / L, preferably 1.0-1.75 mmol / L L MgCl2: 0.3-1.2 mmol / L, preferably 0.5 and 1.0 mmol / L Glucose: 0.8-2.2 g / L, preferably 1.0-2.0 g / L Acid citrus: 0.1-20 mmol / L, preferably 1.015.0 mmol / L,
    [0028] All values refer to the finished dialysis solution. It is conceivable, for example, that 34 liters of a mixture of water and the base concentrate are mixed with 1 liter of the acidic liquid concentrate to obtain 35 liters of ready-to-use dialysis solution. This mixing ratio naturally applies not only to the above example, but can be assumed to be an appropriate mixing ratio in general.
    The preferred volume capacity of the container according to the invention is preferably in the range of 4 to 15 liters.
    [0030] The dry concentrate and therefore also the acid concentrate thus formed can comprise one, a plurality of or all such substances. It is also possible that the dry concentrate, and therefore also the acid concentrate thus formed, comprises more than the aforementioned substances.
    [0031] The supply is made, preferably that the acidic liquid concentrate has a pH <7.0 and / or that the dry concentrate comprises at least one acid.
    [0032] It is conceivable that, in addition to the substances explicitly mentioned, other substances are also located in the dry concentrate such as other electrolytes, buffers, acids, etc.
    [0033] The container can have rigid and / or flexible walls. This is preferably done as a bag or also as a cartridge, which has solid walls.
    [0034] A combination of solid and flexible walls is also conceivable. The container can thus, for example, have a solid wall in the region or regions into which the liquid and / or gas and / or acidic liquid concentrate is introduced and a flexible wall in the remaining regions.
    [0035] Furthermore, it is conceivable that the container is a disposable article. That is why it is understood that the container is discarded, that is, not reused, after the end of its useful life, that is, for example, after about 1 to 3 uses or treatments. It is conceivable to distribute the containers in the form of bags or cartridges or the like, to manufacture the acidic liquid concentrate in it and use it for one or more dialysis treatments. Once it is consumed, the receptacle is thrown away.
    [0036] The dry concentrate can be present in the container in an amount of 0.5 kg to 6 kg, preferably in an amount of 0.75 kg to 5.5 kg, more preferably in an amount of 1.0 kg to 5.0 kg, and especially preferably in an amount between 1.3 and 4.2 kg. Such containers allow trouble-free handling, are easy to transport and store and are suitable for carrying out one or more hemodialysis treatments.
    [0037] It is possible for the dry concentrate to be composed in such a way that the acidic liquid concentrate obtained in its solution in a volume of 2 to 15 liters, or from 4 to 15 liters, preferably in a volume of 4 to 15 liters of liquids, preferably water, has a pH <7.0.
    [0038] It is conceivable that liquid products are included in the container before dissolving the dry concentrate. The process is, however, also covered by the invention, which at least one liquid component, such as an acid, is also present in the dry concentrate. The term "dry concentrate" is, therefore, to be understood in such a way that the dry concentrate is not in a completely dissolved state, that is, to comprise, at least partially, preferably totally, one or more solids.
    [0039] The container can, in addition, be designed in such a way that a volume of the acidic liquid concentrate can be received or is received in the container in the range of 1 to 15 liters, preferably in the range of 2 to 14 liters, even more preferably in the range of 3 to 13 liters, and particularly preferably in the range of 4 to 15 liters.
    [0040] In another embodiment of the invention, the container has at least one means of introduction through which the liquid, preferably water, or liquid, preferably water, and a gas, preferably air, can be introduced into the container in order to dissolve the dry concentrate located in the container. The introduction means can, for example, be a flexible tube, a passage, a tube or another line.
    [0041] The introduction medium can generally be made in such a way that the liquid or the liquid and the gas is / are introduced into a region of the container in which the dry concentrate is located, such as in a lower region of the interior of the container in the operating position.
    [0042] The supply of liquid and / or gas inside the container must therefore be formed in such a way that the end of the introduction medium ends in the dry concentrate, which has the advantage that the supply of liquid or liquid and gas can result in a stirring of the dry concentrate, where its dissolution is accelerated.
    [0043] The gas supplied is preferably filtered sterilized air, within the scope of the present invention.
    [0044] The one or more means of introduction are advantageously so dimensioned that they project into the dry concentrate. It is thus possible for a flexible tube or another line to project, for example, from a wall or a door region of the container into the interior of the container.
    [0045] The delivery is made, in another embodiment, that the container has regions of wall in at least one region between which a region in the form of gutter or depression forms, with the dry concentrate being, at least also present in the gutter-shaped region in the operating position of the container. In this way, it can be ensured that the dry concentrate "slides" into the so-called gutter-shaped region and is then present in a central position that under favorable conditions applies to the dissolution of the dry concentrate.
    [0046] The delivery is therefore preferably made that the container has at least one, or a plurality of funnel-shaped constrictions, and certainly in the region of the lower end of the container. This ensures that the undissolved dry concentrate is located directly at the point of delivery of the fluid or liquid and air during the total dissolution process and is continuously stirred. The time for complete dissolution of the concentrate is, in particular, reduced to a favorable time period by this measure.
    [0047] The means of introduction, that is, the flexible tube, the line or the like, preferably extends to the region in the form of a gutter or even, and to the constriction in the form of a funnel.
    [0048] The delivery can, in particular, be made in such a way that the means of introduction extends to and in the region in the form of a gutter and preferably has at least one opening, preferably at least one opening outlet and / or at least one inlet opening in this region, with provision preferably being made in which the operation of a liquid, preferably water, and gas, preferably air, are introduced through the outlet opening and that , in operation the acidic liquid concentrate is led out of the container through the inlet opening and / or that the outlet opening and the inlet opening are formed by one and the same opening.
    [0049] The supply can, moreover, be done in such a way that the introduction means has a closing element which is arranged and designed in such a way that the penetration of the dry concentrate in the introduction means is prevented. It is ensured, therefore, that no solid can enter the introduction medium, but only gas or air and / or liquid or water or acidic liquid concentrate.
    [0050] The specific weight of the closing element of the introduction medium lies preferably in the range of <11 kN / m, preferably in the range of <10 kN / m and particularly preferably in the range of <9.7 kN / m .
    [0051] In another embodiment of the invention, the container has at least one outlet means, by means of which the acidic liquid concentrate can be led out of the container. This outlet means, for example, may be a flexible tube or another line which, preferably, projects into the container. It is also possible to form the outlet means simply as an opening in the container.
    [0052] The delivery can, in particular, be done in such a way that the output device is formed as a separate component from the input medium and / or that the input medium and the output medium are arranged in different positions or sides of the container, preferably on opposite sides of the container or on the same side of the container.
    [0053] It is conceivable that the outlet means to be partially or totally formed by the means of introduction, according to the possibilities described above. The introduction means and the exit means can thus be one and the same element of the container. A flexible tube or another line can be taken into account, for example. Firstly, ultra pure water or RO water and / or preferably purified or filtered air can be transmitted through it, for example, for the purpose of dissolving the dry concentrate. If the dry concentrate is preferably completely dissolved, the supply can be made in such a way that the acidic liquid concentrate formed in this way is conducted through the same flexible tube or the same line.
    [0054] The concentrated acid is supplied to the dialyzer or used in the dialyzer to manufacture a finished dialysis solution in which the acid concentrate and preferably a base concentrate is mixed with water to form the finished dialysis solution. For this purpose, one or more measuring devices, such as pumps or the like, can be used, which measure the concentrate or concentrates in the appropriate amount of water or for the flow of water that flows, for example, through a main line of so that the finished dialysis solution includes the desired components in the desired concentration.
    [0055] It is conceivable that first a liquid base concentrate and then the acid liquid concentrate according to the invention is mixed with RO water. The supply can be made in this regard that, in each case, about a part of the liquid base concentrate and about a part of the acid liquid concentrate are measured in approximately 33 parts of RO water.
    [0056] The supply can be made in this respect that the RO water flows through a main line that communicates with two secondary lines in one of which the liquid base concentrate is present and in the other of which the acid liquid concentrate is present or which are connected to the respective containers from which the concentrates are manufactured, respectively.
    [0057] The supply can also be made in that the container has at least one purging means that is arranged and designed in such a way that air or other gas can escape from the container, which is preferably the case when liquid and / or gas are introduced into the container in order to dissolve the dry concentrate.
    [0058] The purging means can, for example, be formed by at least one line and / or by at least one membrane or filter, which is arranged, for example, on the wall of the container or in a line or similar, which is attached to the inside of the container so that air can escape. The purging medium is preferably a different component from the means for introducing water and air and for conducting the concentrate.
    [0059] The delivery can also be made in such a way that the container has at least one coding by means of which the container and / or the dry concentrate and / or the liquid acid concentrate can be identified. It is thus possible, for example, for a detection unit to be provided, for example, in the dialyzer, or in the preparation unit, or in yet another device, for example, a manual device, by means of which the encoding can be read. A specific dissolution procedure can be initiated to dissolve the dry concentrate in an automated or manual manner, for example, based on this information. If an automatic coding recognition occurs, delivery can be done in which an automatic dissolution process is initiated to dissolve the dry concentrate without any user interaction. If this is completed, the delivery can still be made that, optionally, also in an automated manner, a unit of measurement of the acid concentrate takes place for the manufacture of the finished dialysis solution.
    [0060] It is conceivable that the dry concentrate is present in the form of a powder and / or in the form of a granulate. As mentioned above, the dry concentrate can comprise only solid substances. The case is, however, also covered by the term "dry concentrate", in the sense of the present invention, in which the liquid components are present in the container.
    [0061] The connection means for coupling the container can be formed in such a way that a connection of the container is only possible through a coupling means of a dialyzer or by means of a preparation unit or by means of a certain type of dialyzer or from a preparation unit for a dialyzer. It is therefore conceivable that the connection means of the container and the coupling means of the dialyzer or the preparation unit fit together in the sense of a key-and-lock principle or are specially adapted for each other so that a defective coupling for dialyzers or preparation units, which are not suitable or are not provided for the use of the container, be prevented.
    [0062] The container can, for example, be called a standing container. Such a container is generally characterized by at least two walls which are connected to each other by a base which is preferably formed so that the container as a whole can stand upright. In this regard, it is conceivable that this upright container is used within the scope of the present invention in such a way that the base is arranged at the top so that, for example, it results in an upside down triangle. This may be, but it does not have to be arranged by not standing upright; an inclined arrangement is also covered by the invention. The delivery is, however, preferably made that the corner of the container opposite the so-called support base is arranged at the bottom or in a bottom region when the container is used.
    [0063] Such a standing container has the advantage of being flat in an empty state provided that the support base is preferably designed in such a way that it can be folded inwards. In the filled state, such a standing container provides a relatively large volume. The container is preferably formed in the form of a flat support container and includes embodiments in which the base is sufficiently stable so that the container can theoretically stand as well as those in which it is not. case.
    [0064] The upright container is preferably arranged so that, in the folded-in state, the upright base has an inwardly folded "base section" whose members are, however, of uneven length so that results in an asymmetric triangle when the container is filled or unrolled. This embodiment has the result that, when filling the container, the "foot base", located at the top is unfolded, with only a small gravity shift results due to the asymmetric model of the foot base folded so that the lower region V-shaped container also remains in this lowest position when the container is full.
    [0065] Efficient dissolution of the dry concentrate can thus be achieved.
    [0066] The delivery is made in a conceivable embodiment of the invention, that the container comprises two films which are sealed together to each other in a suitable manner. It is thus conceivable, for example, to fuse the films together so that the liquid concentrate, which is created by dissolving the dry concentrate, can be received in the container.
    [0067] It is possible to conceive a wall or film as substantially straight and to conceive the other with a folded corner region or marginal region, which has the advantage that the container occupies very little space, in the folded-in state and can receive a large volume in the unfolded state.
    [0068] In a preferred embodiment of the invention, the container therefore comprises exactly two films that form all the walls of the container.
    [0069] The use of the container is preferably provided so that the "base", which can be formed by folding one of the films, is arranged at the top or in an upper area when using the container so that the side opposite the container, which is preferably triangular in longitudinal section, is disposed on the bottom.
    [0070] The present invention also relates to the use of a container according to the present invention for the manufacture of an acidic liquid concentrate which in turn serves for the manufacture of a dialysis solution, preferably a solution of dialysis for hemodialysis. It is conceivable that the dialysis solution is manufactured by dosing the acidic liquid concentrate and, optionally, a base concentrate within a liquid stream or in a volume of liquid, preferably comprising ultrapure water or RO water. This dialysis solution can then, optionally after the addition of other substances and optionally after a suitable temperature treatment, be used as a finished dialysis solution for carrying out a dialysis treatment, preferably a hemodialysis treatment.
    [0071] The invention also relates to the use of an acidic liquid concentrate located in a container according to the invention for the manufacture of a dialysis solution, preferably a dialysis solution which is used for hemodialysis.
    [0072] The present invention also relates to a dialyzer or a preparation unit, with the preparation unit used to manufacture a concentrate for a dialysis solution. The supply is made according to the invention that the dialyzer or the preparation unit is coupled to a container according to the invention or is suitable for coupling such a container.
    [0073] The dialyzer or the preparation unit is therefore suitable to be coupled to a container according to the invention by means of suitable coupling means. The supply is preferably made that the dialyzer or the preparation unit has means by which the dry concentrate located in the coupled container can be completely dissolved in order to be able to supply an acidic liquid concentrate in this way. These means can be designed in such a way that at least one liquid, preferably water or ultrapure water RO, or at least one liquid, preferably water or ultrapure water RO, and at least one gas, preferably air, is / are introduced into the container.
    [0074] The dialyzer or the preparation unit can thus have means, in particular one or more pumps or sources of liquids and / or compressors or sources of compressed air, or is connected or can be connected to them, which are designed in such a way that at least one liquid and / or at least one gas is / can be introduced or introduced by means into the container coupled to the dialyzer or the preparation unit.
    [0075] The solution or acidic liquid concentrate located in the container coupled to the dialyzer or the preparation unit, moreover, can be carried out of the container through these means, in particular, one or more pumps. The acidic liquid concentrate, for example a liquid, for example, water or a mixture of water and a base concentrate, which flows in a main line, can be dosed by means, in order to optionally be able to manufacture a finished dialysis solution after adding a base concentrate.
    [0076] The dialyzer or the preparation unit can have at least one measuring device that is connected to the so-called media or include them, with the measuring device being designed in such a way that it measures the acidic liquid concentrate conducted out of the container in a liquid stream or into a receptacle, preferably partially or completely filled with liquid, preferably with water, for the purpose of making the dialysis solution.
    [0077] The supply can, moreover, be done in such a way that the dialyzer or the preparation unit has at least one main line and at least one secondary line, which opens into the main line and in which or in that the at least one container according to the invention is arranged. It is thus conceivable, for example, that the at least one container is arranged on a secondary line, which is connected to a main line at least at one point or at two points. It is conceivable, in the case of two secondary lines, that water or water and air is / are supplied to the container by a secondary line leading to the container and that the liquid concentrate is conducted out of the receptacle through a conduction line from the receptacle.
    [0078] It is also conceivable that the secondary line is only connected to a main line at one point and the dissolution process is designed in such a way that a liquid, preferably RO water and / or gas flows from the main line to inside the container and, after dissolving the dry concentrate, the concentrated liquid is then conducted again through the same secondary line into the main line or into another line or receptacle.
    [0079] Furthermore, at least one control or regulation unit can be provided which is designed in such a way that it controls or regulates the supply of liquid, preferably water, or liquid, preferably water, and gas, preferably air, into the container and / or the removal of gas, preferably air, and / or the acidic liquid concentrate from the container depending on time and / or according to a specific program and / or provides or introduces it in a predefined amount.
    [0080] The dissolution process is preferably carried out so that no excess pressure or substantial excess pressure is present in the container. Ventilation preferably takes place towards the atmosphere, since the container is directly or indirectly connected to the atmosphere through the device or through the preparation unit.
    [0081] It is also possible for the control or regulation unit to be designed in such a way that it controls or regulates the supply of liquid and / or gas to the container and / or the removal of the solution from the container depending on the time, ie , for example, for a specific duration, or according to a specific time, and / or that a certain amount of water is added to the container to obtain the desired substance concentrations.
    [0082] It is thus conceivable, for example, that the liquid, in particular water, or liquid, in particular water, and the gas, in particular air, is / are supplied to the container for a predefined time or at intervals pre-defined and / or in a defined volume and / or mass.
    [0083] The manufacture of the acid concentrate, preferably, does not occur continuously, but in batches. Air and water are preferably introduced into the dry concentrate or into the container and the excess air is removed again. The supply is preferably also carried out in such a way that the liquid concentrate is driven from the container by a pump or the like, after the complete dissolution of the dry concentrate.
    [0084] The supply is preferably made that the recipe prescribes a certain amount of water. This amount of water is then carried out, for example, in discrete portions or continuously. A measurement of water in the form of a plurality of 30 ml volumes, which are added one after the other, is conceivable, for example.
    [0085] The supply can also be made in such a way that the control or regulation unit is designed in such a way that the supply of liquid or liquid and gas occurs continuously, in intervals or in batches. It is conceivable, for example, to add a specific amount of liquid water once and to introduce, continuously or once or intermittently or permanently, a gas, in particular air, into the container to accelerate the dissolution process.
    [0086] The present invention furthermore relates to another embodiment of a dialyzer or a preparation unit. The supply is made in this respect in such a way that a dialyzer or a preparation unit, with the preparation unit providing the manufacture of a concentrate for making a dialysis solution, being designed in such a way that the dialyzer or the preparation unit preparation have at least one connection means by which means of a compressed air line are connectable or connected to a liquid line means with liquid or liquid and gas being possible to supply, by means of connection means for a container that includes at least one dry concentrate, and with the acidic liquid concentrate being able to be led out of the container by means of the connection means.
    [0087] It is possible that at least one control or regulation unit is provided which is designed in such a way that it controls or regulates the supply of liquid, preferably water, or liquid, preferably water, and gas, preferably air, into the container and / or the removal of gas, preferably air and / or acidic liquid concentrate out of the container and / or that the dialyzer or the preparation unit has, in addition, the characterization aspect of according to one of claims 7-9. The container can be, in particular, a container according to one of claims 1 to 4 and / or according to the description above. It is also conceivable that the dialyzer or the preparation unit are suitable for coupling a container according to one of claims 1 to 4 and / or according to the description above. The liquid can be water, in particular RO water, and the gas can be, in particular, air.
    [0088] It is, therefore, in particular conceivable that a connection is provided in a dialyzer or in a unit for preparing a compressed air line for a water line that serves for the supply of RO water into the container and to conduct the concentrate. In addition, this dialyzer or preparation unit has a control and / or regulation unit having a program for the simultaneous introduction of air and water.
    [0089] The present invention also relates to a method for the manufacture of an acidic liquid concentrate that serves for the manufacture of a dialysis solution, with the method including the following steps: Coupling a container according to the invention a a dialyzer or a preparation unit, complete dissolution of the dry concentrate, and removal of the acidic liquid concentrate obtained by complete dissolution of the dry concentrate from the container.
    [0090] It is conceivable that a liquid, preferably water, or a liquid, preferably water, and gas, preferably air, are introduced into the container in order to dissolve the dry concentrate.
    [0091] The delivery can, moreover, be done in which first a liquid, preferably water, and subsequently a gas, preferably air, or liquid, preferably water, and gas, preferably air, are simultaneously introduced into the container in order to dissolve the dry concentrate.
    [0092] It is possible that the liquid, preferably water, or liquid, preferably water, and the gas, preferably air, is / are transmitted for a specific period of time and / or in specific volume or mass and / or by a specific number of transport movements and / or for a specific period of operation of a transport unit. The liquid or the liquid and the gas can therefore be transported for a specific period of time by a specific number of transmission movements of a transport unit, such as a pump inside a container. It is conceivable that, for example, a specific number of dialyzer balance chamber fillers is used to fill the container according to the invention with liquid or water.
    [0093] When using a dialyser balance chamber as a measurement system for the addition of the solvent and / or to remove the liquid concentrate, it is not possible to add any desired volume, but only integer multiples of the volume of the balance chamber. In order to obtain the correct concentration of the finished dialysis solution with a pre-defined amount of salt, the concentrations obtained in the dissolution are taken into account in the dilution of the concentrate. A similar process is a form known in EP 0 548 537 A2 for which reference is made in this regard.
    [0094] If, for example, the desired volume of the balance chamber or dosing chamber is equivalent to 30 mL, the exact volume of the chamber may differ due to a tolerance in the range of -1 mL to +2 mL. This exact volume of the balance chamber can be equivalent to 29.50 ml, as an example. This value is present in the dialyzer.
    [0095] If the recipe now prescribes a quantity of water, for example, 4,500 mL, this results from 4500 mL: 29.5 mL = 152,542 transitions from the measurement system. This corresponds to 152 transitions and a residue of 29.5 ml * 0.52 = 15.99 ml. These 15.99 mL are taken into account when calculating the actual mixing ratio.
    [0096] The pumping volume of the concentrate pump is then calculated from the ratio of the mixture in the bag or receptacle, calculated in this way and communicated to said pump.
    [0097] The values mentioned above are of course only of an exemplary nature and should only illustrate the general procedure as it can be used when used in the balance chamber system as a dosing device. This procedure is also part of the present invention.
    [0098] The delivery can also be done in such a way that the transmission or absorption of the solution located in the container is measured and the dimension in which the dry concentrate is dissolved is determined depending on it. If, for example, the transmission reaches a specific value, it can be concluded from this that the dry concentrate is completely dissolved. The acidic liquid concentrate formed in this way can then be carried out of the container and used to make a dialysis solution.
    [0099] It is conceivable that the liquid or the liquid and the gas is / are introduced continuously, at intervals or in batches into the container and / or the solution is conveyed to the container continuously, at intervals or in batches. The delivery is made in such a way that a conduction of the solution from the receptacle only occurs when the dry concentrate is completely dissolved.
    [0100] It is possible that the supply of liquid, preferably water, or liquid, preferably water, and gas, preferably air, into the container occurs in such a way that the dry concentrate is completely immersed in the liquid, preferably water, and / or in such a way that the dry concentrate is moved, preferably agitated, through the gas, preferably air.
    [0101] The amount of water supplied resulting, for example, from the composition of the powder / granules. A certain amount of powder or granules has to be mixed with a specific amount of water. The powder / granules must be capable of being fully dissolved by this amount of water. When dissolving or filling with water and introducing air, the container is preferably opened to the environment, and, in fact, preferably via a corresponding coupler of the dialyzer or the preparation unit.
    [0102] It is preferable that the solution located in the container, that is, the acid liquid concentrate, is only taken from the container, when the dry concentrate located in the container is completely dissolved. The complete dissolution of the dry concentrate is to be aimed at, not only in order to optimally use the material of the dry concentrate, but also to provide a reproducible composition of the acid concentrate.
    [0103] Other details and advantages of the invention result from an embodiment shown in the drawing. They are shown:
    [0104] Figure 1: a schematic view of a container according to the invention that is partially filled with dry concentrate;
    [0105] Figure 2: a perspective view of a receptacle according to the invention as well as a coupling region of a dialyzer or a preparation unit before coupling the receptacle;
    [0106] Figure 3: a schematic view of an embodiment of the container according to the invention, during manufacture and also during the opening procedure;
    [0107] Figure 4: a longitudinal sectional view through a container according to the invention, as well as a perspective view of the container according to the invention;
    [0108] Figure 5: a plan view of the film net for the manufacture of the container;
    [0109] Figures 6, 7: schematic representations of the manufacturing process.
    [0110] The container 10 is designed as a bag 10 having flexible walls 14. The bag 10 or its walls may comprise a plastic, which is preferably made transparent.
    [0111] The following statements are not restricted to a bag, but can also apply to any other receptacle, such as a cartridge with rigid walls.
    [0112] In the region of the bag 10, in the lower part, in the operating position, two wall sections 17, 18 are located which are both designed as inclined in relation to the horizontal and are dropped, respectively from the outside to the and form a gutter-shaped region 19 between them, which constitutes the lowest point or region where the dry concentrate 20 is located in the interior space of the container.
    [0113] As can still be seen from the Figure, container 10 is not completely filled with dry concentrate 20, but only in part.
    [0114] In the embodiment shown, less than half of the container 10 is filled with dry concentrate 20. Air or other gas is above the volume of this material.
    [0115] The dry concentrate comprises the following substances: electrolytes, glucose and citric acid or other suitable acid, in solid or liquid state.
    [0116] The mentioned electrolytes can be selected from the group of NaCl, KCl, CaCl2, MgCl2. Conceivable amounts for one liter of finished dialysis solution can be in the range of 130-150 mmol of NaCl, 1-4 mmol of KCl, 1-1.75 mmol CaCl2 and 0.5-1 mmol MgCl2. This value can be in the range from 1 mmol / L - 15 mmol / L of citric acid.
    [0117] Glucose can be present in the dry concentrate in an amount such that a glucose concentration in the range of 1 - 2 mmol / L results in the ready-to-use dialysis solution.
    [0118] A possible procedure comprises the dosage of the so-called components individually and the formation of a granulate from all the components, which is then poured into the container or bag 10, as a dry concentrate 20.
    [0119] Bag 10 can have a volume or intake capacity of about 4-15 liters of the acidic liquid concentrate that is formed by the dry concentrate solution. This amount may be sufficient for 1-3 hemodialysis treatments.
    [0120] The bag 10 has a special connection element 12 in its region shown at the top in the Figure with which the bag can be suspended by a dialyzer or a filling station which is also called a preparation unit within the scope of present invention. The connecting element 12 can be made in such a way that it can be connected, preferably in a fluid-proof and / or gas-proof manner, to a special coupler of the dialyzer or a preparation unit. This connection can be established, for example, by a simple connection in or by a rotating movement or through a screw connection.
    [0121] After establishing this connection, liquid and / or gas can be introduced into bag 10 via line 16. If the dry concentrate is completely dissolved, the acidic liquid concentrate can also be removed from bag 10 via line 16 Line 16 projects, from an upper wall of the container, from top to inside the container and down and to the lowest point of the interior space of the receptacle 10 or in the dry concentrate present there.
    [0122] The dry concentrate containing the salt may be present in bag 10 in an amount of, for example, 1.3-4.2 kg.
    [0123] As can still be seen from Figure 1 and has already been mentioned above, the bag has a socket 16 which is formed in the form of a flexible tube 16, and whose open end is at the aforementioned lowest point 19 of bag 10.
    [0124] The inlet or flexible tube 16 is provided in its end region that protrudes into the container with a lid, a plug, a membrane or the like as protection to prevent the penetration of the dry concentrate into the tube 16. The specific weight of this closure is preferably in the range of <9.7 kN / m3.
    [0125] filling with water, the introduction of air and the drawing of the liquid concentrate occurs through line 16.
    [0126] The reference number 16 'indicates an element that serves as a ventilation for the atmosphere during the filling of the container. After filling, or after dissolving the dry concentrate, this vent 16 'can be closed. This means that element 16 'has no function during treatment.
    [0127] Even though the element 16 'is shown as a short line element in Figure 1, the provision is preferably made in such a way that no line 16' is present, but only one element, such as a filter, etc. , through which air can escape from the interior of the container 10. The container 10, therefore, preferably has only exactly one line 16, which serves for the supply of water and gas and conduction of the liquid concentrate.
    [0128] When emptying the container at the final stage of treatment, suction occurs at both outlets 16 and 16 'to empty the container as soon as possible.
    [0129] Instead of the element 16 'or in addition, a filter can be fitted in the connection medium 12, which prevents the dust from moving out of the bag during transport.
    [0130] The liquid concentrate produced can be mixed with a volume of water, preferably RO water, to be able to produce the finished dialysis solution. The liquid base concentrate, which can also be obtained by dissolving a dry concentrate in a container coupled to the dialyzer or a preparation unit, can be measured before or after the addition of the acidic liquid concentrate.
    [0131] In general, it is covered by the invention that the container containing the base concentrate is disposed spatially separate from the container containing the dry acid concentrate. The case is, however, also covered by the invention that both containers are connected to each other and optionally form different compartments or chambers of a common container or bag.
    [0132] To allow air to escape from the container when it is filled with water and / or air, a ventilation element is provided - as indicated - that can be connected to the dialyzer or the preparation unit. This can be formed by a filter, with this, preferably being arranged on the wall of the bag or in the region of the connection means 12. This filter must be made in such a way that it allows air and liquid to pass through, but not dust. or granulated so that it cannot move unintentionally out of the container.
    [0133] In order to be able to carry out a clear identification of the bag, it is conceivable that it be formed with an encoding, such as a bar code, a 2-matrix code or RFID. It is conceivable that the dialyzer and / or a preparation unit have a reading unit for the manufacture of the acidic liquid concentrate, by means of which this code can be detected or read. Based on this information, a process for dissolving the dry concentrate 20 in the bag 10 can be initiated, preferably automatically, by the dialyzer or the preparation unit.
    [0134] It is conceivable in this regard that the details of the method will depend on the so-called coding of the bag or coding of the container. This can apply, for example, for the amount of added water or water and air added for the dissolution of the dry concentrate, for the duration of the dissolution process, for the question of whether the dissolution process is assisted by the supply of air, for the purpose of adding air and water, for the question of when a continuous, intermittent or single (batch) dissolution process occurs, etc.
    [0135] The conductivity limit values can also be defined based on the code.
    [0136] A possible dissolution process procedure can be designed, for example, such that first water, preferably RO water, is added into bag 10 through flexible tube 16 at a water temperature of 37 ° C at 85 ° C.
    [0137] The water flow can be in the range of up to 1200 mL / mm.
    [0138] In a subsequent second phase, the air can then, preferably, also be introduced through line 16 in bag 10 for a specific period.
    [0139] As an alternative to this, the introduction of water and air into the container can occur simultaneously.
    [0140] It is also possible to introduce air into the container at the same time as the water, so as to interrupt the water inlet flow and to continue the water supply, preferably until the complete dissolution of the salt or dry concentrate 20.
    [0141] Either water or any other liquid can generally be added into bag 10 or container 10 in such a way that it is either completely filled or is only partially filled.
    [0142] The filling of bag 10 with water can occur, for example, by a set of numbers of fillers in the balance chamber of the balance chamber / measurement chamber of a dialyzer. The effective filling volume of the bag 10 can then be determined with the aid of the known volume of the balance chamber. The concentrations of the individual substances result from the ratio of powder or granules to water. Any other measurement possibilities such as a pump, etc., can be used to fill the bag with water.
    [0143] The duration of the gas supply, which is preferably purified air or filtered air, may be dependent on the filling volume and / or depends on the air flow.
    [0144] In an embodiment of the invention, a timer is provided, in such a way that it performs the filling or preparation of the acid liquid concentrate, after the end of the last dialysis (AutoOFF) or before the start of dialysis (AutoON). The use of a timer for the preparation unit, which is also called the filling station, is possible.
    [0145] If a plurality of dialysis treatments are carried out one after the other with the same bag 10, it is possible to carry out an intermediate disinfection between the treatments. It is conceivable to fill before purging, with no risk of contamination being present, since this is the primary circuit.
    [0146] An "interval determination" is, moreover, possible, that is, the determination of the possible time of use for the optimization of the use of the acid liquid concentrate, and is also covered by the invention.
    [0147] Instead of a container with the liquid acid concentrate, especially for bicarbonate dialysis, a bag or other container is used with a dry salt concentrate according to the invention. This bag or container is filled in the dialyzer or in a filling station, preferably with a defined amount of water, for dialysis, and is preferably dissolved by the introduction of filtered air to be sterilized. After the dissolution process, an acid concentrate is available which meets the requirements in accordance with the standard EN 13867: 2002, in a preferred embodiment of the invention.
    [0148] Figure 2 shows an exemplary embodiment of the container according to the invention with the connecting means 12, which serves for the coupling to the coupling means of a preparation unit or a dialyzer.
    [0149] The arrangement, which can be seen from Figure 2 represents, in a preferred embodiment according to the invention, for the coupling of a container 10 for the dialyzer or for a preparation unit which is generally characterized by reference numeral 50.
    [0150] Air and water can be introduced through port 52 of the unit or the preparation unit via connection means 12 for the container 10 and through the flexible tube 16 into the lower region of the container. For this purpose, a connection from port 52 to connection 120 on the container side occurs.
    [0151] The container 10 or its connection medium 12 is connected by means of another coupler or connector 122 to the dialysis machine or to the preparation machine. The associated line is correspondingly marked by reference number 51.
    [0152] This is connected to the element 16 'of the receptacle.
    [0153] Air is sucked out of the container through the port or line 51 during the dissolution process or during the process of filling the reservoir with water and air.
    [0154] Unlike the teaching known from EP 1 344 550 B1, line 52 or line 16, according to the present invention, not only serves for the supply of water and air, but also conducts the dissolved concentrate. It is sucked out via line 16 and line 52 by means of suitable means of transport, for example, means of a pump, and is then diluted at a suitable point in the dialyzer or in the preparation unit so that, eventually after the addition of a base concentrate, a finished dialysis solution can be provided. This means that the flow path through the connection means and the coupling means, as well as through the flexible water pipe used for the dissolution, at least regionally, corresponds to that through which the concentrated liquid is conducted. One and the same pump can also be used to supply water, on the one hand, and to drive the liquid concentrate, on the other hand.
    [0155] As can be seen from Figure 2, the ports or lines 51, 52 have tops where the connectors 120, 122 of the container 10 are preferably connected, so that the receiving regions of the connectors 120 122 receive the tips. For this purpose, recesses or receivers 53, 54 are arranged in the unit or in the preparation unit in which the so-called tips project and in which the corresponding connectors 120, 122 are inserted, when the container 10 is coupled. In the coupled state, the tips project into the receptors of connectors 120, 122 or are less connected to them in such a way that a fluid-tight connection is established.
    [0156] The connector 120 is in fluid communication with the flexible tube 16 and the connector 122 is in fluid communication with the element 16 'or with a container filter. Such a connection can, for example, be achieved by a groove or the like in the wall of the connectors 120, 122, as described in EP 1 344 550 B1. The chamber which is also described in more detail in DEP 1 344 550 B1 can be located between the connector 120, 122 and the line 16 and the element 16 '.
    [0157] As indicated, element 16 'is preferably not a flexible tube or the like, but only a medium that allows air and, optionally, liquid to pass and retain the dry powder / granules.
    [0158] In this way, water and air can be supplied to container 10 and the concentrated liquid can be carried out of container 10 via line 52 on the side of the unit and through connector 120. Air can be removed or it can escape from the container via line 51 on the side of the unit and connector 122.
    [0159] In the installed state of the receptacle 10, the cover 59 of the unit or of the preparation unit pivotable about the axis 65 is then folded down, that is, after the coupling of the receptacle 10, so that the tips 70, 71 arranged in the cover 59, press from above to the connectors 120, 122 of the connection means 12 and hold them in a coupled position. If no receptacle is used, the tips 70, 71 can engage the cutouts 53, 54, so that a fluid-tight connection results in the same way. A purification process can be carried out in this position of the lid.
    [0160] Reference numeral 60, finally, marks the end of the bag region 10, which is sealed in connection with the connecting element 12.
    [0161] Figure 3 shows a first film with reference film 500 and a second film of an embodiment of container 10 with reference number 600. The folded region connecting the two films 500 and 600 is marked by the number reference 700. This folded region 700 can be designed as a separate part or can be connected in one piece to one of the films 500, 600. As can be seen from Figure 3, the folded region 700 is formed by two members which are sharply arranged for each other, but are not the same length.
    [0162] Figure 3 shows, in addition, the process of opening the container from the folded state shown on the left of the arrow, and in the unfolded state shown on the right side of the arrow.
    [0163] This is achieved by the members of the folding zone 700 of unequal lengths which when unrolling the center of gravity moves less than with members of equal length, so that the V-shaped tip of the container shown by the number of reference 710 remains at the bottom, which is of importance for the dissolution process.
    [0164] The term "film" used in the context of the present invention is to be interpreted in a general way and includes any material of the container wall. This can be done as elastic, flexible, etc.
    [0165] Films 500, 600 and fold 700 or corner region 700 can comprise the same material.
    [0166] Figure 4, illustration on the left, shows the container according to Figure 3 in a longitudinal section and in perspective view. The connection means 12 by means of which the container can be coupled to a dialyzer or to a preparation unit for the acid concentrate, is arranged in the upper region of the container. This connection means is in fluid-proof connection with the adjacent films or wall regions of the container 10.
    [0167] As can be seen from Figure 4, the wall of the container is formed by a film and the other wall of the container, by another film, which has the section of the folded type. It can be seen, from the figures, that the container occupies relatively little space in the folded state, but has a large intake volume for the dry concentrate or for the dissolved concentrate in the unfolded state.
    [0168] The delivery is made in a preferred embodiment of the invention, in such a way that the container or its walls is / are manufactured exactly from two films.
    [0169] Figure 5 shows a film network comprising two lines 800, 900 in a plan view. As can be seen from the Figure, the film sections to form the container walls are formed in a trapezoidal shape in a plan view and are arranged in two networks such that the lower 900 line of the trapezoidal sections is upside down in relation to the upper 800 line of the trapezoidal sections, that is, it is standing on its head. This allows a good use of the film material.
    [0170] As can still be seen from Figure 5, the cutouts 1000 are kept relatively small in this way and are, preferably, likewise not located between the mutually adjacent trapezoids.
    [0171] As it is marked with the reference symbol A, the welding is produced in a single step, according to the pattern shown M and the cutting of the films takes place in a next step B, also according to the pattern M.
    [0172] Figure 6 shows the films 500, 600, which form the container in a perspective representation. As can be seen from Figure 5 and as indicated by the arrows, the tallest of the films 500 is folded first in step 1 and then welded the lower film mesh 600 in step 2. The cutting step of the two films for mutually producing separate containers is not shown in Figure 5. Reference numeral 1100 marks the apparatus for welding the respective film sections.
    [0173] In a preferred embodiment of the invention, the individual films are each multilayer film, preferably two-layer films. One layer represents a sealing layer that has a low melting temperature. The other layer has a higher melting temperature than this and has a mechanical strength or resistance that is good with respect to it.
    [0174] The use of polyamide (high melting temperature, good resistance properties, transparent and visually attractive) and polyethylene (lower melting temperature, easy to weld) is conceivable. This two-layer film represents a good option for the manufacture of the container according to the invention.
    [0175] The thickness of the films is preferably 200 micrometers and the sizing of the films is carried out in which the filled container can have a volume of 5 liters.
    [0176] Figure 7 shows the two films 500, 600, which form the rear walls of the container in the illustration on the left. In a first stage of the method, the films are rolled (Figure 7, illustration on the left). A pleat or twist is then produced in one of the 500 films, as can be seen from Figure 7, representation of the middle and the right side. This twisting is carried out in such a way that the length of the two films in the folded state of the film 500 is substantially identical. The region formed by the two parts 501 forms a wall of the container 10, the other walls are formed by sections adjacent to the film 500 and the film 600.
    权利要求:
    Claims (20)
    [0001]
    1. Container (10) comprising: a dry concentrate (20) provided so that the dry concentrate (20) forms an acidic liquid concentrate or a part of an acidic liquid concentrate which is suitable for making a dialysis solution in its dissolving in a liquid; CHARACTERIZED by the fact that the container additionally comprises: a connector (12) with which the container can be coupled to a dialyzer or to a preparation unit (50) for the acidic liquid concentrate the connector (12) which includes a part of the first connector (120) and a part of the second connector (122) adapted to cooperate with the corresponding connection elements of the dialyzer or the preparation unit (50), the part of the first connector (120) that communicates the liquid and a gas to the container (10), which communicates the acid liquid concentrate of the container, and the part of the second connector (122) which communicates only the gas of the container; and an introduction means (16) with which liquid and gas can be introduced into the container to dissolve the dry concentrate (20), the introduction means (16) being in fluid communication with the part of the first connector (120 ), being configured as a tube or including a tube, and being sized to project into the dry concentrate (20), with the acidic liquid concentrate having a pH value of less than 7.0 when dissolving the dry concentrate in 2 to 15 liters of the liquid.
    [0002]
    2. Container (10), according to claim 1, CHARACTERIZED by the fact that it additionally comprises wall regions (17, 18) with faces facing each other in a region and between them a gutter-shaped region (19 ) or a recess is formed, with the dry concentrate (20) being present in the gutter-shaped region (19) or in the recess in the operating position of the container (10).
    [0003]
    3. Container (10) according to claim 1, CHARACTERIZED by the fact that the connector (12) is configured so that a connection of the container (10) is only possible for the coupling means of the dialyzer or the preparation (50) for the dialyzer, with the first connector part (120) and the second connector part (122) having one or more voids, passages, or lines configured so that the liquid, the acidic liquid concentrate, and the gas flow through them in operation.
    [0004]
    4. Container (10) according to claim 1, CHARACTERIZED by the fact that the container (10) is configured as a standing container.
    [0005]
    5. Container (10) according to claim 1, CHARACTERIZED by the fact that it additionally comprises at least two films that form the respective walls of the container (10), with one of the at least two films having a section folded in the empty state of the container. container (10), which forms one of the walls in the filled state of the container (10).
    [0006]
    6. Container (10), according to claim 1, CHARACTERIZED by the fact that the acidic liquid concentrate is associated with a dialysis solution for hemodialysis.
    [0007]
    7. Container (10), according to claim 4, CHARACTERIZED by the fact that the container has a standing section arranged in an upper part when manufacturing the dialysis solution in the container (10).
    [0008]
    8. Container (10), according to claim 1, CHARACTERIZED by the fact that the liquid is water.
    [0009]
    9. Container (10), according to claim 1, CHARACTERIZED by the fact that the gas is air.
    [0010]
    10. Dialyser or preparation unit (50), where the preparation unit provides the manufacture of a concentrate for the manufacture of a dialysis solution, CHARACTERIZED by the fact that the dialyser or preparation unit (50) comprises: a container (10) coupled to the dialyzer or the preparation unit (50), the container (10) which includes at least one dry concentrate, the dry concentrate (20) being formed so that the dry concentrate (20) forms at least one concentrate acidic liquid or a portion of an acidic liquid concentrate that is suitable for making at least one dialysis solution upon dissolving the dry concentrate (20) in a liquid, and the container (10) being configured to have at least one element connection device (12) through which the container (10) is attachable to the dialyzer or the preparation unit (50) for the acidic liquid concentrate, and the dialyzer or the preparation unit (50) having an element configured so that the liquid and at least a gas are introduced through the element in the container (10) coupled to the dialyzer or the preparation unit (50).
    [0011]
    11. Dialyser or preparation unit (50), according to claim 10, CHARACTERIZED by the fact that the liquid is water and at least one gas is air.
    [0012]
    12. Dialyser or preparation unit (50) according to claim 10, CHARACTERIZED by the fact that the dialyser or preparation unit includes an element (52) configured in such a way that the acidic liquid concentrate located in the container (10) coupled with the dialyzer or the preparation unit (50) it can be guided outwards or it is guided through the element (52) of the container (10), the element being the element of introduction of the container.
    [0013]
    13. Dialyser or preparation unit (50), according to claim 10, CHARACTERIZED by the fact that it additionally comprises a control unit or regulation unit configured to control or regulate at least one or a few sources of liquid and gas inside the container ( 10), a removal of the gas from the container (10) and a removal of the liquid acid concentrate from the container (10).
    [0014]
    14. Dialyser or preparation unit (50), the preparation unit used for the manufacture of a concentrate for the manufacture of a dialysis solution, the dialyser or the preparation unit (50) FEATURED by the fact that it comprises: an element connection means (16, 52) whereby (i) a compressed air line means is connectable or connected to a liquid line means, with a liquid and a gas having the ability to provide by means of the connection means into a container (10) including a dry concentrate (20), and (ii) an acidic liquid concentrate is capable of being introduced outside the container (20).
    [0015]
    15. Dialyser or preparation unit (50), according to claim 14, CHARACTERIZED by the fact that it additionally comprises a control or regulation unit configured to control or regulate at least one source of liquid and gas into the container (10 ), a removal of gas from the container (10), and a removal of acidic liquid concentrate from the container (10).
    [0016]
    16. Method of manufacturing a liquid concentrate, which serves to manufacture a dialysis solution, said method CHARACTERIZED by the fact that it comprises the following steps: coupling the container (10) as defined in claim 1 to a dialyzer or to a unit preparation (50); introducing the liquid and gas into the container (10) to dissolve the dry concentrate (20) contained therein; and conducting out of the container (10) the acidic liquid concentrate obtained by dissolving the dry concentrate (20) contained therein.
    [0017]
    17. Method according to claim 16, CHARACTERIZED by the fact that it additionally comprises a step of removing the gas from the container (10).
    [0018]
    18. Method according to claim 16, CHARACTERIZED in that the acidic liquid concentrate located in the container (10) is only driven out of the container (10) when the dry concentrate (20) located in it is completely dissolved.
    [0019]
    19. Method for the manufacture of a container (10) as defined in claim 1, said method CHARACTERIZED by the fact that it comprises the following steps: supply of two films (500, 600), introducing a fold (700) in one of the two films (500, 600), and connecting the two films (500, 600) with a solder, to manufacture the container (10), with a folded region (700) being an upper portion of the container (10), and being formed by two members that are acutely disposed of each other, and have an uneven length.
    [0020]
    20. Dialyser or preparation unit (50), the preparation unit used for the manufacture of a concentrate to manufacture a dialysis solution, the dialyser or the preparation unit (50) FEATURED by the fact that it comprises: a connecting element (16, 52) through which a compressed air line means is connectable or connected to a liquid line means, a liquid and gas being supplanted through the connection element (16, 52) to a container (10) the container (10) including a dry concentrate (20) that forms an acidic liquid concentrate or a part of an acidic liquid concentrate suitable for making the dialysis solution upon dissolving the dry concentrate (20) in the liquid, a connector (12) with which the container (10) can be coupled to the dialyzer or preparation unit (50), the connector (12) including a part of the first connector (120) and a part of the second connector (122) adapted to cooperate with the corresponding coupling elements of the connecting element (16, 52), the part of the first connector (120) communicating the liquid and gas to the container (10), and communicating the acidic liquid concentrate of the container (10), and the part of the second connector (122 ) communicating the gas in the container (10), and an introducing element (16) with which the liquid and gas can be introduced into the container (10) to dissolve the dry concentrate, the introducing element (16) being in a fluid communication with the first connector part (120), being configured as a tube or including a tube, and being sized to project into the dry concentrate (20), with the acidic liquid concentrate being removable from the container via the introducing element (16) and the connecting element (16, 52), and with the acidic liquid concentrate having a pH below 7.0 when dissolving the dry concentrate in 2 to 15 liters of the liquid.
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    法律状态:
    2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-10-08| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-09-29| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application [chapter 6.1 patent gazette]|
    2021-01-19| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-03-02| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 29/06/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201161503808P| true| 2011-07-01|2011-07-01|
    DE102011106248A|DE102011106248A1|2011-07-01|2011-07-01|Container, use, dialysis machine or preparation unit and method for producing a concentrate|
    DE102011106248.7|2011-07-01|
    US61/503,808|2011-07-01|
    PCT/EP2012/002738|WO2013004362A1|2011-07-01|2012-06-29|Container, use, dialysis device or preparation unit and method for producing a concentrate|
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