Container, use, dialyzer or preparation unit as well as method of manufacturing a concentrate

Abstract

A container includes a dry concentrate designed such that the dry concentrate forms an acid liquid concentrate, or a part of an acid liquid concentrate, which is suitable for manufacturing a dialysis solution, on the dissolution of the dry concentrate in a liquid, preferably in water.

Claims

1. A container comprising: at least one dry concentrate, the dry concentrate being provided so that the dry concentrate forms at least one acid liquid concentrate or a part of an acid liquid concentrate which is suitable for manufacturing at least one dialysis solution on a dissolving thereof in a liquid; at least one connector with which the container is coupleable to a dialyzer or to a preparation unit for the acid liquid concentrate; a first film and a second film which form walls of the container, with one of the first film and the second film having a folded section in an empty state of the container which forms one of the walls of the container in a filled state of the container, with the folded section being formed by two limbs which are arranged acutely to one another, and which have a different length from one another, and with the folded section connecting the first film and the second film which form the walls of the container; and wall regions which face toward one another in at least one region and between which a trough-shaped region or a recess is formed, with the dry concentrate being at least also present in the trough-shaped region or in the recess in an operating position of the container, with the two opposite walls of the container being the first film and the second film, and the base being the folded section, so that an asymmetrical triangle results when the container is filled or unfolded.

2. The container in accordance with claim 1, wherein the folded section is configured as a separate part or is connected in one piece to one of the first film and the second film.

3. The container in accordance with claim 1, wherein the container is configured as a stand-up container.

4. The container in accordance with claim 3, wherein the stand-up container has a stand-up section arranged at a top thereof during use of the container.

5. The container in accordance with claim 1, wherein the first film and the second film and the folded section, or a corner region thereof, have a same material of construction.

6. The container in accordance with claim 1, wherein a thickness of the first film and the second film is 200 micrometres and a dimensioning of the first film and the second film is such that the filled container occupies a volume of 5 liters.

7. The container according to claim 1, wherein the acid liquid concentrate is associated with a dialysis solution for hemodialysis.

8. The container according to claim 1, wherein the liquid is water.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Further details and advantages of the invention result from an embodiment shown in the drawing. There are shown:

(2) FIG. 1: a schematic view of a container in accordance with the invention which is partly filled with dry concentrate;

(3) FIG. 2: a perspective view of a receptacle in accordance with the invention as well as a coupling region of a dialyzer or of a preparation unit before the coupling of the receptacle;

(4) FIG. 3: a schematic view of an embodiment of the container in accordance with the invention during manufacture and well as during the opening procedure;

(5) FIG. 4: a longitudinal sectional view through a container in accordance with the invention as well as a perspective view of the container in accordance with the invention;

(6) FIG. 5: a plan view of the film web for manufacturing the container;

(7) FIGS. 6, 7: schematic representations of the manufacturing process.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

(8) Further scope of applicability of the present invention will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description.

(9) The container 10 is designed as a bag 10 which has flexible walls 14. The bag 10 or its walls can comprise a plastic which is preferably made transparent.

(10) The following statements are not restricted to a bag, but can rather equally apply to any other receptacle such as a cartridge with rigid walls.

(11) In the region of the bag 10 at the bottom in the operating position, two wall sections 17, 18 are located which are both designed as sloping with respect to the horizontal and are made falling respectively from the outside to the inside and form a trough-shaped region 19 between them which forms the bottommost point or region in which the dry concentrate 20 is located in the inner container space.

(12) As can further be seen from the Figure, the container 10 is not completely filled with dry concentrate 20, but rather only in part.

(13) In the embodiment shown, less than half the container 10 is filled with dry concentrate 20. Air or another gas is located above this bulk material.

(14) The dry concentrate comprises the following substances: electrolytes, glucose and citric acid or another suitable acid in solid or liquid form.

(15) The name electrolytes can be selected from the group NaCl, KCl, CaCl.sub.2, MgCl.sub.2. Conceivable amounts relating to a liter of the finished dialysis solution can be in the range from 130-150 mmol NaCl, 1-4 mmol KCl, 1-1.75 mmol CaCl.sub.2 and 0.5-1 mmol MgCl.sub.2. This value can be in the range from 1 mmol/l-15 mmol/l for citric acid.

(16) Glucose can be present in the dry concentrate in a quantity such that a glucose concentration in the range of 1-2 mmol/l results in the ready-to-use dialysis solution.

(17) A possible procedure comprises weighing out the named components individually and forming a granulate from all components which is then poured into the container or bag 10 as a dry concentrate 20.

(18) The bag 10 can have a volume or an intake capacity of approximately 4-15 liters of the acid liquid concentrate which is formed by the solution of the dry concentrate. This quantity can be sufficient for 1-3 hemodialysis treatments.

(19) 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 at a dialyzer or at a filling station which is also called a preparation unit within the framework of the present invention. The connection element 12 can be made such that it can be connected, preferably in a fluid-tight and/or gas-tight manner, to a special coupler of the dialyzer or of a preparation unit. This connection can be established, for example, by a simple plugging on or by a rotary movement or by a screw connection.

(20) After establishing this connection, liquid and/or gas can be introduced into the bag 10 by means of the line 16. If the dry concentrate is completely dissolved, the acid liquid concentrate can likewise be drawn out of the bag 10 by means of the line 16. The line 16 projects, starting from an upper container wall, from above into the interior of the container and down to and into the lowest point of the inner space of the receptacle 10 or into the dry concentrate present there.

(21) The dry concentrate containing salt can be present in the bag 10 in a quantity of, for example, 1.3-4.2 kg.

(22) As can further be seen from FIG. 1 and was already mentioned above, the bag has an inflow 16 which is formed in the manner of a hose 16 and whose open end lies at the above-named lowest point 19 of the bag 10.

(23) The inflow or the hose 16 is provided in its end region projecting into the container with a cap, a plug, a membrane or the like as protection to prevent the penetration of the dry concentrate into the interior of the hose 16. The specific weight of this closure is preferably in the range <9.7 kN/m.sup.3.

(24) The filling with water, the introduction of air and the drawing off of the liquid concentrate takes place through the line 16.

(25) The reference numeral 16′ shows an element which serves as a venting to the atmosphere during the filling of the container. After the filling or after the dissolving of the dry concentrate, this venting 16′ can be closed. This means that the element 16′ has no function during the treatment.

(26) Even though the element 16′ is shown as a short line element in FIG. 1, provision is preferably made that no line 16′ is present, but rather only an element such as a filter, etc. via which air can escape from the interior of the container 10. The container 10 thus preferably has only exactly one line 16 which serves the supply of water and gas and the leading off of the liquid concentrate.

(27) On the emptying of the container in the final stage of the treatment, suction takes place at both outlets 16 and 16′ to empty the container as quickly as possible.

(28) Instead of the element 16′ or in addition thereto, a filter can be seated in the connection means 12 which prevents powder from moving out of the bag during transportation.

(29) The produced liquid concentrate can be mixed with a volume of water, preferably RO water, to be able to produce the finished dialysis solution. The base liquid concentrate, which can likewise be obtained by dissolving a dry concentrate in a container coupled to the dialyzer or to a preparation unit, can be metered in before or after the addition of the acid liquid concentrate.

(30) It is generally covered by the invention that the container containing the base concentrate is arranged spatially separate from the container which contains the acid dry concentrate. The case is, however, also covered by the invention that both containers are connected to one another and optionally form different compartments or chambers of a common container or bag.

(31) To allow the escape of air from the container on its filling with water and/or air, a venting element is provided—as stated—which can be connected to the dialyzer or to the preparation unit. This can be formed by a filter, with this preferably being arranged in the bag wall or in the region of the connection means 12. This filter should be made such that it allows air and liquid to pass through, but no powder or granulate so that it cannot unintentionally move out of the receptacle.

(32) To be able to carry out a clear identification of the bag, it is conceivable that it is formed with a coding such as a barcode, a 2-matrix code or RFID. It is conceivable that the dialyzer and/or a preparation unit has a reading unit for manufacturing the acid liquid concentrate by means of which this coding can be detected or read out. Based on this information, a method for dissolving the dry concentrate 20 in the bag 10 can be initiated, preferably automatically, by the dialyzer or by the preparation unit.

(33) It is conceivable in this respect that the details of the method depend on the named bag coding or container coding. This can apply, for example, to the quantity of the added water or of the added water and the air for dissolving the dry concentrate, to the duration of the dissolving procedure, to the question whether the dissolving procedure is assisted by the supply of air, to the order of the addition of air and water, to the question whether a continuous, an intermittent or a single (batch-wise) dissolving procedure takes place, etc.

(34) Conductivity limit values can furthermore be set on the basis of the coding.

(35) A possible procedure of the dissolving process can be designed, for example, such that first water, preferably RO water, is added into the bag 10 through the hose 16 at a water temperature of 37° C. to 85° C.

(36) The water flow can be in a range up to 1200 ml/mm.

(37) In a second subsequent phase, air can preferably then likewise be introduced via the line 16 into the bag 10 for a specific period.

(38) Alternatively to this, the introduction of water and air into the container can take place simultaneously.

(39) It is also possible to introduce air into the container simultaneously with the water, then to stop the water inflow and to continue the water supply, preferably up to the complete dissolving of the salt or of the dry concentrate 20.

(40) So much water or any other liquid can generally be added into the bag 10 or container 10 that it is completely filled or is only partly filled.

(41) The filling of the bag 10 with water can take place, for example, by a whole-number number of balance chamber fillings of the balance chamber/metering chamber of a dialyzer. The actual filling volume of the bag 10 can then be determined with the aid of the known balance chamber volume. The concentrations of the individual substances result from the ratio of powder or granulate to water. Any other metering possibility such as a pump, etc. can be used for filling the bag with water.

(42) The duration of the supply of the gas, which is preferably purified air or filtered air, can be in dependence on the filling volume and/or depend on the airflow.

(43) In an embodiment of the invention, a timer is provided which carries out the filling or preparation of the acid liquid concentrate after the end of the last dialysis treatment (AutoOFF) or before the start of the dialysis (AutoON). The use of a timer for the preparation unit, which is also called a filling station, is possible.

(44) If a plurality of dialysis treatments are carried out after one another with the same bag 10, it is possible to carry out an intermediate disinfection between the treatments. It is conceivable to do the filling before the purging, with no contamination risk being present since it is the primary circuit.

(45) A “range determination” is furthermore possible, i.e. a determination of the possible time of use for the optimum utilization of the acid liquid concentrate, and is also covered by the invention.

(46) Instead of a canister with liquid acid concentrate, in particular for bicarbonate dialysis, a bag or another container is used with a dry salt concentrate in accordance with the invention. This bag or container is filled at the dialyzer or at a filling station, preferably with a defined quantity of water for the dialysis, and is preferably dissolved by the introduction of air filtered to be sterile. After the dissolving process, an acid concentrate is available which corresponds to the demands in accordance with EN 13867:2002 in a preferred embodiment of the invention.

(47) FIG. 2 shows an exemplary embodiment of the container in accordance with the invention with the connection means 12 which serves the coupling to the coupling means of a preparation unit or of a dialyzer.

(48) The arrangement which can be seen from FIG. 2 represents in a preferred embodiment an arrangement in accordance with the invention for the coupling of a container 10 to the dialyzer or to a preparation unit which is generally marked by the reference numeral 50.

(49) Air and water can be introduced through the port 52 of the unit or of the preparation unit by the connection means 12 to the container 10 and through the hose 16 into the lower region of the container. For this purpose, a connection of the port 52 to the connection 120 at the container side takes place.

(50) The container 10 or its connection means 12 is connected via a further coupler or connector 122 to the dialysis machine or to the preparation machine. The correspondingly associated line is marked by the reference numeral 51.

(51) It is connected to the element 16′ of the receptacle.

(52) Air is drawn out of the container through the port or the line 51 during the dissolving process or during the filling process of the container with water and air.

(53) Different from the teaching known from EP 1 344 550 B1, the line 52 or the line 16 in accordance with the present invention does not only serve the supply of water and air, but also the leading off of the dissolved concentrate. It is drawn off through the line 16 and the line 52 by means of a suitable conveying means, for example by means of a pump, and is then diluted at a suitable point in the dialyzer or in the preparation unit so that, optionally after adding 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 hose of the water used for the dissolving at least regionally corresponds to that via which the liquid concentrate is led off. One and the same pump can also be used to supply the water, on the one hand, and to lead off the liquid concentrate, on the other hand.

(54) As can be seen from FIG. 2, the ports or the lines 51, 52 have stubs onto which the connectors 120, 122 of the receptacle 10 are placed, and preferably plugged, so that receiving regions of the connectors 120, 122 receive the stubs. For this purpose, recesses or receivers 53, 54 are arranged at the unit or at the preparation unit into which the named stubs project and into which the corresponding connectors 120, 122 are inserted when the container 10 is coupled. In the coupled state, the stubs project into receivers of the connectors 120, 122 or are least connected therewith such that a fluid-tight connection is established.

(55) The connector 120 is in fluid communication with the hose 16 and the connector 122 is in fluid communication with the element 16′ or with a filter of the receptacle. Such a connection can, for example, be achieved by a groove or the like in the wall of the connectors 120, 122, as is described in EP 1 344 550 B1. A chamber which is likewise 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′.

(56) As stated, the element 16′ is preferably not a hose or the like, but rather only a means which allows the air and optionally liquid to pass and holds back the dry powder/granulate.

(57) Accordingly, water and air can be supplied to the container 10 and the liquid concentrate can be led off out of the container 10 via the line 52 at the unit side and via the connector 120. Air can be removed or can escape from the container via the line 51 at the unit side and the connector 122.

(58) 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, i.e. after the coupling of the receptacle 10, so that the stubs 70, 71 arranged at the cover 59 press from above onto the connectors 120, 122 of the connection means 12 and hold them in the coupled position. If no receptacle is used, the stubs 70, 71 can engage into the cut-outs 53, 54 so that a fluid-tight connection likewise results. A purging process can be carried out in this position of the cover.

(59) The reference numeral 60 finally marks the end region of the bag 10 which is sealingly connected to the connection element 12.

(60) FIG. 3 shows a first film with the reference film 500 and a second film of an embodiment of the container 10 with the reference numeral 600. A folded region which connects the two films 500 and 600 is marked by the reference numerals 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 FIG. 3, the folded region 700 is formed by two limbs which are arranged acutely to one another, but do not have the same length.

(61) FIG. 3 furthermore shows the opening process of the container from the folded state shown to the left of the arrow and in the unfolded state shown to the right of the arrow.

(62) It is achieved by the limbs of the fold region 700 of unequal lengths that on the unfolding the center of gravity moves less than with limbs of equal length so that the V-shaped tip of the container shown by the reference numeral 710 remains at the bottom, which is of importance for the dissolving process.

(63) The term “film” used within the framework of the present invention is to be interpreted generally and includes any wall material of the container. It can be made as elastic, flexible, etc.

(64) The films 500, 600 and the fold 700 or the corner region 700 can comprise the same material.

(65) FIG. 4, left hand illustration, shows the container in accordance with FIG. 3 in a longitudinal sectional representation and in a 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-tight connection with the adjacent films or wall regions of the container 10.

(66) As can be seen from FIG. 4, a wall of the container is formed by a film and the other wall of the container by the other film which has the fold-like section. It can be seen from the Figures that the container takes up 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.

(67) Provision is made in a preferred embodiment of the invention that the container or its walls is/are manufactured exactly from two films.

(68) FIG. 5 shows the film web which comprises two rows 800, 900 in a plan view. As can be seen from the Figure, the film sections for forming the container walls are formed in trapezoidal shape in a plan view and are arranged in the two webs such that the lower row 900 of the trapezoidal sections is upside down with respect to the upper row 800 of the trapezoidal sections, i.e. is standing on its head. This allows a good utilization of the film material.

(69) As can further be seen from FIG. 5, the clippings 1000 are kept relatively small in this manner and are preferably likewise not located between the mutually adjacent trapezoids.

(70) As is marked by the reference symbol A, the welding is produced in one step in accordance with the shown pattern M and the cutting of the films takes place in a step B following it likewise in accordance with the pattern M.

(71) FIG. 6 shows the films 500, 600 which form the container in a perspective representation. As can be seen from FIG. 5 and as indicated by arrows, the upper one of the films 500 is first folded in step 1 and then welded to the lower film web 600 in step 2. The step of the cutting of the two films to produce mutually separate containers is not shown in FIG. 5. The reference numeral 1100 marks the apparatus for welding the respective film sections.

(72) In a preferred embodiment of the invention, the individual films are each multilayer films, preferably two-layer films. One layer represents a sealing layer which has a low melting temperature. The other layer has a higher melting temperature in respect to this and has a mechanical strength or resistance which is good relative thereto.

(73) The use of polyamide (high melting temperature, good resistance properties, transparent and visually appealing) and polyethylene (lower melting temperature, easy to weld) is conceivable. Such a two-layer film represents a good option for manufacturing the container in accordance with the invention.

(74) The thickness of the films is preferably 200 micrometers and the dimensioning of the films is carried out in that the filled container can take up a volume of 5 liters.

(75) FIG. 7 shows the two films 500, 600 which form the later walls of the container in the left hand illustration. In a first method step, the films are rolled off (FIG. 7, left hand illustration). A fold or a kink is then produced in one of the films 500, as can be seen from FIG. 7, middle and right hand representation. This kink is carried out such that the length of the two films in the kinked state of the film 500 is substantially identical. The region formed by two limbs 501 forms a wall of the container 10; the further walls are formed by the adjacent sections of the film 500 and by the film 600.

(76) The invention being thus described, it will be apparent that the same may be varied in many ways. Such variations are not to be regarded as a departure from the spirit and scope of the invention, and all such modifications as would be recognized by one skilled in the art are intended to be included within the scope of the following claims.