CONTAINER FOR DIALYSIS

Abstract

A container containing a concentrate for dialysis includes a pouch or cartridge containing a solid concentrate of constituents for the dialysis solution, the pouch or cartridge being closed by a connector having a filling channel extending completely through the connector, which is for filling the pouch or cartridge with the solid concentrate, means for introducing a solution-forming liquid into the pouch or cartridge and for extracting the solution obtained, these introduction and extraction means having at least one connecting portion for connecting them to a corresponding port of the dialysis machine. The filling channel is closed by a stopper which has a reservoir containing a second constituent or group of constituents for the dialysis solution, and means for producing an outlet opening in the reservoir contacting the inside of the reservoir with the side of the stopper located in the container.

Claims

1-22. (canceled)

23. Container for a concentrate for dialysis, which container comprises a pouch or a cartridge intended for containing a solid concentrate of constituents of the composition of the dialysis solution, and a connector for sealingly closing the pouch or the cartridge, wherein the connector is provided with means for introducing a solution-forming liquid into the pouch or cartridge and for extracting the solution obtained from the pouch or the cartridge, the introduction and extraction means being provided with at least one connecting portion for connecting the introduction and extraction means to a corresponding port of the dialysis machine, a filling channel extending completely through the connector and intended for filling the pouch or the cartridge with the solid concentrate, and a stopper for sealingly closing the filling channel, wherein the stopper is equipped with a reservoir intended for containing a second constituent or group of constituents of the composition of the dialysis solution, and opening means for producing an outlet opening in the reservoir, wherein the outlet opening contacts the inside of the reservoir with a side of the stopper located in the container, wherein the stopper comprises a housing, forming the reservoir, and a rod, forming the opening means, wherein the housing has a first peripheral wall, a lower wall at a lower part of the first peripheral wall, and an upper wall at an upper part of the first peripheral wall, wherein the lower wall has a first opening, wherein the reservoir has a second opening, wherein the rod is mobile in translation between a first position and a second position, wherein, in the first position of the rod, a first portion of the rod is located in the reservoir or at least in part in the first opening, and a second portion of the rod is located at least in part in the second opening for sealing the second opening, and wherein, in the first position of the rod, the first opening is closed by a membrane or by the first portion of the rod, and in the second position of the rod, the first opening is open at least partially.

24. The container according to claim 23, wherein the first opening is a lower passage opening surrounded by a housing sleeve extending on a side of the lower wall opposite the upper wall, wherein the second opening is an upper passage opening surrounded by a second sleeve extending toward the lower wall, wherein the second portion of the rod has a first annular seal dimensioned so as to ensure sealing of the reservoir at an interface between the rod and the second sleeve in the first position of the rod, wherein the first portion of the rod has at least one recess or radial narrowing having a height greater than a height of the housing sleeve, wherein the rod is mobile in translation in the second sleeve between the first position and the second position, wherein, in the first position of the rod, the first annular seal is located in the second sleeve, and wherein, in the second position of the rod, the first opening is open or at least partially open through the at least one recess or radial narrowing of the rod.

25. The container according to claim 24, wherein a free end of the housing sleeve is closed by a membrane, and wherein a lower end of the rod is provided with means for piercing the membrane when the rod is moved from the first position to the second position.

26. The container according to claim 24, wherein the first portion of the rod has a second annular seal dimensioned so as to ensure sealing of the reservoir at an interface between the rod and the housing sleeve, and wherein, in the first position of the rod, the second annular seal is located in the housing sleeve.

27. The container according to claim 23, wherein the pouch contains a solid concentrate containing glucose and/or the reservoir of the stopper contains an acid.

28. The container according to claim 27, wherein the acid is in liquid form.

29. The container according to claim 23, wherein the introduction and extraction means comprise a fluid line for introducing a solution-forming liquid into the pouch or the cartridge, and a fluid line for extracting the solution obtained from the pouch or the cartridge, each fluid line extending from an orifice located in the pouch or the cartridge to a respective connecting portion located outside the container, the connecting portions being configured for connecting each fluid line to a corresponding port of a dialysis machine.

30. The container according to claim 29, wherein the two fluid lines are combined into a single fluid line.

31. Container according to claim 23, wherein the first peripheral wall is provided with sealing means to ensure sealing between the stopper and the opening of the container, these sealing means being constituted by the material used for the first peripheral wall and/or by an annular seal.

32. The container according to claim 23, wherein the first peripheral wall (i) is made of a compressible material dimensioned so that the first peripheral wall is pressed against and matches exactly a peripheral wall of the filling channel, and/or (ii) has an annular seal that protrudes radially toward a peripheral wall of the filling channel and is pressed against and matches exactly the peripheral wall of the filling channel.

33. The container according to claim 23, further comprising retaining means, where the retaining means are placed on the rod so as to maintain the rod in the first position sealingly closing the reservoir, and when the retaining means are removed, the rod can be pushed toward the second position freeing the first opening.

34. The container according to claim 23, wherein the stopper is provided with means for limiting its penetration into the filling channel to a predetermined depth.

35. The container according to claim 34, wherein the penetration limiting means comprise a radial rim whose dimensions are greater than dimensions of the filling channel.

36. The container according to claim 23, wherein anti-extraction means are provided to prevent extraction of the opening means from the stopper.

37. The container according to claim 23, wherein venting means are provided to produce an air passage between the inside and the outside of the container when the means for producing an outlet opening in the reservoir have been actuated.

38. The container according to claim 37, wherein the venting means are in the form of at least one axial recess in the second part of the rod.

39. The container according to claim 23 arranged in a dialysis machine provided with one or more ports dimensioned to receive the connecting portion or portions of the connector.

40. The container according to claim 23, wherein the first peripheral wall is a cylindrical wall and the lower and upper walls are oblique or radial walls, wherein the upper wall forms a lid of the housing, wherein the first portion of the rod is a lower portion having at least one recess or radial narrowing, and wherein the first position of the rod is an upper position and the second position of the rod is a lower position in which the first opening is open or partially open through the recess or radial narrowing of the rod.

41. Method of extemporaneous preparation of a dialysis solution in a dialysis machine provided with a container according to claim 23, wherein the following steps are performed: a) putting the container in place in the dialysis machine and introducing the connecting portion or portions into the corresponding ports of the machine; and b) introducing the solution-forming liquid into the container via the introduction fluid line; wherein the following additional steps carried out prior to step a) or between step a) and step b): c) actuating the means for opening the reservoir contained in the stopper so as to produce the opening; d) letting the contents of the reservoir flow into the pouch or the cartridge.

42. The method according to claim 41, wherein step c) is performed automatically by the dialysis machine after step a).

43. The method according to claim 41, wherein step c) is performed at the time of closing a retaining cover present in the dialysis machine and intended for retaining the container during the dialysis.

44. The method according to claim 41, wherein step c) is performed manually before or after step a).

45. The method according to claim 41, wherein the stopper contains an acid and/or the pouch or the cartridge contains a solid concentrate containing glucose.

46. The method according to claim 41, wherein the stopper contains an acid.

47. The method according to claim 46, wherein the acid is in liquid form.

Description

[0031] The invention is described below in more details using four exemplary embodiments shown in the following figures:

[0032] FIG. 1: Perspective view of a connector for a dialysis container;

First Embodiment

[0033] FIG. 2: Exploded perspective view of the various elements of the first stopper;

[0034] FIG. 3: Cross sectional view of the elements of FIG. 2;

[0035] FIG. 4A: Perspective view of the first stopper with the piston in filling position;

[0036] FIG. 4B: Perspective view of the first stopper with the stopper closed in storage configuration;

[0037] FIG. 5A: Reservoir opening stage of the first stopper placed in the filling opening of a cartridge for dialysis, in an initial position;

[0038] FIG. 5B: Reservoir opening stage of the first stopper placed in the filling opening of a cartridge for dialysis, with the safety tab removed;

[0039] FIG. 5C: Reservoir opening stage of the first stopper placed in the filling opening of a cartridge for dialysis, with the piston pushed down;

Second Embodiment

[0040] FIG. 6: Perspective view of the various elements of the second stopper;

[0041] FIG. 7A: Cross-sectional view of the stopper in filling position;

[0042] FIG. 7B: Cross-sectional view of the stopper in storage configuration;

[0043] FIG. 8A: Reservoir opening stage of the second stopper placed in the filling opening of a cartridge for dialysis, in its initial position;

[0044] FIG. 8B: Reservoir opening stage of the second stopper placed in the filling opening of a cartridge for dialysis, with the clip removed;

[0045] FIG. 8C: Reservoir opening stage of the second stopper placed in the filling opening of a cartridge for dialysis, with the rod pushed down;

Third Embodiment

[0046] FIG. 9: Perspective view of the various elements of the third stopper;

[0047] FIG. 10A: Cross-sectional view of the stopper in filling position;

[0048] FIG. 10B: Cross-sectional view of the stopper in storage conditions;

[0049] FIG. 11A: Reservoir opening stage of the third stopper placed in the filling opening of a cartridge for dialysis, in initial position;

[0050] FIG. 11B: Reservoir opening stage of the third stopper placed in the filling opening of a cartridge for dialysis, with the clip removed;

[0051] FIG. 11C: Reservoir opening stage of the third stopper placed in the filling opening of a cartridge for dialysis, with the rod pushed down;

Fourth Embodiment

[0052] FIG. 12: Exploded perspective view of the various elements of the fourth stopper;

[0053] FIG. 13: Cross-sectional view of the elements of FIG. 12 rotated by a quarter turn;

[0054] FIG. 14A: Stage of use of the fourth stopper, in filling position in perspective view;

[0055] FIG. 14B: Stage of use of the fourth stopper, in the same position as FIG. 14A, in cross-sectional view;

[0056] FIG. 14C: Stage of use of the fourth stopper, in storage position in cross-sectional view;

[0057] FIG. 14D: Stage of use of the fourth stopper, in opening position in cross-sectional view;

Venting Device

[0058] FIG. 15A: Cross-sectional view of a first stopper shown schematically, before actuation of the means for opening the reservoir;

[0059] FIG. 15B: Cross-sectional view of a first stopper shown schematically, after actuation of the means for opening the reservoir;

[0060] FIG. 16A: Cross-sectional view of a second stopper shown schematically, before actuation of the means for opening the reservoir; and

[0061] FIG. 16B: Cross-sectional view of a second stopper shown schematically, after actuation of the means for opening the reservoir.

[0062] The description of the various parts of the stoppers of the invention uses spatial references such as upper, lower or vertical. These spatial references refer to the stopper shown in the usual position of use in a dialysis machine as shown in FIG. 5A-5C, 8A-8C, or 11A-11C, for example. In this case, the stopper is located above the container that it closes. However, these positions are not absolute, and it is possible to use the stopper of the invention in another position, especially with the stopper below the vial that it closes. For example, in FIG. 4A and are 10A, some elements of the stopper are shown upside down for filling: the lower wall is then above the upper wall. In addition, the stoppers of these exemplary embodiments have an axis of rotational symmetry corresponding to the direction of insertion of the stopper into the opening of the container that it must close. References such as radial or axial refer to this axis of symmetry. It is immediately understood that if the stopper does not have such a rotational symmetry, these references are used by analogy in relation to an imaginary line passing through the center of the transverse cross-section of the stopper and oriented in the direction of insertion of the stopper into the opening.

[0063] The invention relates to containers used as refills for dialysis. These refills are made up mainly of a pouch or a cartridge fixed on a connector (9). They generally contain a solid concentrate. Refills of the invention make it possible to use, in particular, solid concentrates containing glucose.

[0064] The connector is provided with means for introducing the solution-forming liquid to extract the obtained solution. These means comprise, in particular, a connecting portion (91) for connecting the container to a corresponding port on the dialysis machine. In the example shown in FIG. 1, the introduction and extraction means are constituted by two fluid lines, one for introducing purified water and the other for drawing the saturated solution. Each fluid line is provided at its outer end with a connecting portion (91, 92) intended to penetrate into a port of the dialysis machine. The other ends of the fluid lines open into the inside of the pouch or the cartridge. It is also possible to provide that the two fluid lines are combined into a single fluid line serving both for introducing the solution-forming liquid and for drawing the solution produced. The equivalent of the second line can be used as air intake to ensure the pressure balance if the pouch or cartridge is rigid. It is necessary to provide a central filling channel (93) in the connector for introduction of the solid product, for example, the solid concentrate containing glucose, into the container. After completion of the filling operation, the central channel (93) must be closed sealingly so that no dirt can penetrate into the container and pollute its contents. When the solution to be manufactured contains only the first product contained in the pouch or cartridge, the channel (93) can be sealed by a film. If, on the contrary, the solution must contain a second product that must be separated from the first product during storage of the product contained in the pouch or cartridge, for example, acid, the filling channel (93) can be closed by a stopper equipped with a reservoir.

[0065] The stopper (10, 20, 30, 40) is constituted by a cylindrical wall (11, 21, 31, 41) that can be closed at both ends by a lower radial wall (12, 22, 32, 42) and an upper radial wall (13, 23, 33, 43), the first (12, 22, 32, 42) being located inside the container and the second (13, 23, 33, 43) being located outside the container when the stopper is put in place in the opening of the container, as shown for example in FIG. 5A-5C, 8A-8C, or 11A-11C. The area delimited by the cylindrical wall (11, 21, 31, 41) and the two radial walls (12, 13, 22, 23, 32, 33, 42, 43) forms a closed reservoir (R1, R2, R3, R4). Means are provided in the stopper to produce an outlet opening that contacts the inside the reservoir with the side of the stopper located in the container when the stopper is put in place in the opening of a container, these opening means being operable from outside the container.

[0066] The cylindrical wall (11, 21, 31, 41) is intended to penetrate at least in large part into the opening (93) of the container so as to close it sealingly. Once in place, the cylindrical wall cannot move with respect to the closed opening.

[0067] To ensure sealing, the cylindrical wall (11, 21, 31, 41) can be made in a rubber-type material so that it exactly matches the contours of the wall of the opening to ensure sealing directly. It is also possible that the transverse cross-section of the cylindrical wall (11, 21, 31) of the stopper is slightly less than the transverse cross-section of the opening to be closed. In this case, the stopper can be provided with an annular seal (111, 211, 311) that comes to bear against the wall of the opening (93).

[0068] To limit the penetration of the stopper into the opening to be closed (93), the upper edge of the cylindrical wall (11, 21, 31, 41) is provided with an outwardly oriented radial rim (112, 212, 312, 412) whose dimensions are greater than the transverse cross-section of the opening to be closed (93).

[0069] In a first embodiment of the invention, the stopper (10) is constituted by a housing (A1) and a piston (B1). The housing (A1) is constituted in one piece by the cylindrical wall (11) and the lower radial wall (12). The thickness of the lower radial wall (12) is less important at its periphery than in the rest of the wall, so that this reduction constitutes a weakness zone (124) at the junction between the cylindrical wall and the lower radial wall.

[0070] The piston (B1) is constituted, on the one hand, by a radial wall constituting the upper radial wall (13), and on the other hand, by a second cylindrical wall (131). The edge of the free end of the second cylindrical wall (131), which is the end opposed to the upper radial wall, is preferably inclined, that is to say, it is longer on one side than on the other. In other words, the height of the second cylindrical wall varies between a maximum height and minimum height. In addition, this edge is preferably beveled so as to form a sort of cutting blade. This second cylindrical wall (131) is intended to penetrate into the first (11) when the stopper is assembled. It is dimensioned so that its beveled edge faces the weakness zone (124) of the lower radial wall of the housing. The upper radial wall (13) of the piston is wider than the cylindrical wall (11) of the housing.

[0071] A detachable safety tab (132) is fixed to the periphery of the radial wall (13). It is constituted by a cylindrical wall extending in the same direction as the second cylindrical wall (131) and on the same side of the upper radial wall (13). Its free end, which is the end opposed to the upper radial wall, is dimensioned so as to bear against the rim (112) of the cylindrical wall (11) of the housing when the stopper is assembled. This safety tab (132) extends preferably completely around the radial wall (13). It can be torn off, which then makes it possible to press the piston (B1) down into the housing (A1). The height of the second cylindrical wall (131) and the height of the safety tab (132) are selected so that, when the safety tab (132) bears against the rim (112), the free end of the second cylindrical wall (131) is located in the vicinity of the lower radial wall (12) without touching it, in alignment with the weakness zone (124). Conversely, when the security tab (132) is torn off and the piston (B1) is fully pushed down in the housing (A1), the lower end of the second cylindrical wall tears the zone of weakness (124) over all or part of its length and protrudes at least partly out of the housing (A1). The piston stroke is limited by the radial wall (13) coming into abutment against the rim (112). Therefore, the maximum height of the second cylindrical wall (131) and the height of the safety tab (132) are selected so that the difference between these two heights is less than the height of the first cylindrical wall (11) measured between the lower radial wall (12) and the rim (112), while the height of the first cylindrical wall (11) measured between the lower radial wall (12) and the rim (112) is less than the maximum height the second cylindrical wall.

[0072] The lower radial wall (12) constitutes means for closing the reservoir (R1). The piston (B1) with the inclined and beveled edge of the second cylindrical wall performs the function of opening means. The slot that appears between the lower end of the cylindrical wall (11) and the edge of the lower radial wall (12) in the area where the weakness zone (124) is torn constitutes an output opening (128) for the product contained in the reservoir (R1). The safety tab (132) acts as blocking means.

[0073] To fill the stopper (10), it is necessary, as shown in FIG. 4A, to first turn the piston (B1) over, and to place the liquid or solid in the cup formed by the second cylindrical wall (131) and the radial wall (13). The housing (A1) is then slipped over the piston. The first cylindrical wall (11) of the housing comes to surround the second cylindrical wall (131) of the piston. The rim (112) of the housing comes to abut against the free end of the safety tab (132). Latching means that are not shown prevent the piston (B1) from coming out of the housing (A1). These latching means not shown serve as anti-extraction means. The stopper (10) thus assembled and filled is shown in FIG. 4B. It is in the storage configuration in which it can be stored separately or introduced into an opening (93) until the time of forming the solution.

[0074] The stopper (10) filled with a first product, for example, acid, is placed in the opening (93) of the container after filling thereof with the second product, a solid concentrate containing glucose, for example. This is the situation shown in FIG. 5A. At the time of use, the operator removes the security tab (132) and places the cartridge in the dialysis machine (FIG. 5B). The piston is then pushed, either manually or by the dialysis machine. The inclined and beveled edge of the second cylindrical wall (131) comes in contact, in the area of the maximum height, with a point of the weakness zone (124) of the lower radial wall (12). The further descent of the piston causes perforation of the weakness zone at the first contact point then tearing of the weakness zone along with the penetration of the piston. Depending on the height of the second cylindrical wall (131) at its shortest point compared to the height of the cylindrical wall (11) of the housing, the lower radial wall (12) remains attached by a portion of its weakness zone to the cylindrical wall (11), as shown in FIG. 5C, or is completely torn and falls into the container.

[0075] In a second embodiment, the stopper (20) comprises a housing (A2), a lid (B2), a rod (24) and a clip (25). The housing (A2) is constituted in one piece by the cylindrical wall (21) and the lower radial wall (22). An opening (221), called lower wall opening, is provided in the lower radial wall (22), preferably in the center thereof. This opening (221) is surrounded by a cylindrical sleeve (222) oriented downwardly, that is to say, away from the cylindrical wall (21). An annular radial edge (212) oriented outwardly is placed in the upper portion of the cylindrical wall, preferably in the area of its upper edge. An annular groove (213) is formed on the inner face of the cylindrical wall (21), in the vicinity of the rim (212). The upper end of the inner face of the cylindrical wall (21) preferably has the form of a truncated cone that widens in a direction away from the lower radial wall (22).

[0076] The lid (B2) is essentially constituted by a planar radial wall (23), called upper radial wall, which has the form of a disc. The lid is crossed in its middle by an opening (231), called lid opening. A sleeve (232) surrounding this opening (231) is provided on the lower face of the radial wall (23), that is to say, the face oriented toward the inside of the reservoir (R2) when the lid (B2) is placed on the housing (A2). On this same lower face, a cylindrical flange (233) concentric with the sleeve (232) was placed on the circumference of the disc (23)). On the outer face of this flange is located an annular rib (234). The peripheral edge of the radial wall (23) has a frustoconical shape that widens in a direction toward the outer face of the disc (23).

[0077] The dimensions of the lid (B2) are chosen so that its flange (233) comes to be embedded in the upper end of the housing (A2). The rib (234) of the lid enters the annular groove (213) of the housing so that the lid is retained in the housing. The frustoconical edge of the lid comes into contact with the frustoconical edge of the cylindrical portion (21), these two frustoconical surfaces having complementary shapes. The opening (231) of the lid and the opening (221) of the housing are aligned. The sleeve (232) of the lid and the sleeve (222) of the housing are coaxial. Sealing of the lid in the area of the lid/housing interface is ensured by the contact between the two frustoconical surfaces and/or by the embedding of the rib (234) of the lid in the groove (213) of the housing.

[0078] A membrane (223) closes the sleeve (222) that surrounds the opening (221) of the housing (A2). This membrane performs the function of means for closing the outlet opening.

[0079] The opening means of the reservoir (R2) comprise a mobile rod (24) intended for tearing the membrane (223) that closes the reservoir at the time of use. The rod is received in the stopper (20) by passing through the sleeve (232) of the lid. Its lower end (242) penetrates partly into the sleeve (222) of the housing. The rod is surmounted by a knob (241).

[0080] Once introduced into the stopper, the rod can take two main positions. In the first position, called high position or closed position, shown in FIGS. 7B and 8A, its lower end (2 42) is located inside the sleeve (222) of the housing in the vicinity of the membrane (223) but without touching it. The upper portion of the rod with the knob (241) is located outside the stopper, above the upper radial wall (23). The rod (24) is held in this position by a removable clip (25) placed around the rod between the knob (241) and the upper radial wall (23). This clip (25) serves as blocking means.

[0081] When the clip (25) is removed, it is possible to push the rod further down into the stopper until it reaches a second position, called low position or open position, shown in FIG. 8C. In this low position, the lower face of the knob (241) is in abutment against the radial wall (23) of the lid while the lower end (242) protrudes out of the sleeve (222) of the housing (A2) after tearing the membrane (223). In this low position, only the button (241) protrudes out of the stopper on the upper side. The length of the rod is therefore greater than the distance between the outer face of the upper radial wall (23) and the lower end of the sleeve (222) of the housing, when the lid is placed on the housing.

[0082] In order to ensure sealing of the reservoir (R2) in the area of the rod (24), the rod is provided with a first annular seal (243). This seal is arranged so that, when the rod is in the high position, the seal (243) is located inside the sleeve (232) of the lid (23), bearing against it. In the low position of the rod, this seal (243) is located outside the sleeve (232) of the lid, below it. If sealing must be maintained in the area of the stopper so as to avoid, in particular, entry of contaminated air into the container, it is possible to place the seal (243) so that, even in the low position of the rod, it remains in the sleeve (232).

[0083] To prevent the rod from being removed from the stopper, thus providing access to the inside of the reservoir, an annular retaining shoulder (247) is provided on the rod, below the seal (243). This shoulder is intended to be placed below the sleeve (232) of the lid (B2) once the rod (24) has been inserted into the stopper in the high position after filling. The cross-section in the radial (horizontal) plane of this shoulder is greater than that of the lid sleeve. The shoulder has a triangular transverse cross-section in an axial (vertical) plane, its lower face, oriented toward the free end (242) of the rod, being inclined upwardly and away from the rod while its upper face is in the radial (horizontal) plane or slightly inclined upwardly and away from the rod. The distance between the upper face of the retaining shoulder (247) and the lower face of the knob (241) is equal to or slightly greater than the distance defined by the height of the clip (25) and that of the sleeve (232). Thanks to its inclined lower face, the shoulder does not impede the introduction of the rod into the stopper, however, its radial or also slightly upwardly inclined upper face prevents upward extraction of the rod, by coming in abutment against the lower end of the sleeve (232). The retaining shoulder (247) performs the role of anti-extraction means.

[0084] When the rod (24) is in the high position, the reservoir (R2) is sealingly closed in the area of the sleeve (222) of the housing, thanks to the membrane (223), and in the area of the sleeve (232) of the lid, thanks to the seal (243).

[0085] To allow the contents of the reservoir (R2) to flow out of the stopper, it is provided to form at least one axial recess (244) in the area of the lower end (242) of the rod. This or these recesses (244) are longer than the height of the sleeve (222) of the housing (A2) so that in the low position of the rod, they project above and below the sleeve (222). The upper portions of these recesses stop below and at a distance from the seal (243).

[0086] It would also be possible to replace the recess or recesses (244) by a general narrowing of the section of the rod in the same area as the recesses (244) thus replaced. This narrowing must also be longer than the height of the sleeve (222) so that, in the low position of the rod, it extends above and below this sleeve (222). The upper portion of this narrowing stops below and at a distance of the seal (243).

[0087] Thus, to release the contents of the reservoir (R2), the clip (25) must be removed, then pressure must be applied on the knob (241) of the rod toward the lower radial wall (22). The lower end of the rod tears off the membrane (223) and protrudes out of the sleeve (222) so that the recesses (244) or the narrowing are placed in the sleeve, thereby providing one or more outlet openings (228) for the product contained in the reservoir (R2).

[0088] Although it is not imperative to maintain sealing of the stopper in the area of the rod while the reservoir is opened, it can be useful to provide one or more axial recesses (245) in the upper part of the rod, between the knob (241) and the seal (243), to allow air to enter the reservoir (R2) when the rod is in the low position. These axial recesses extend up to within the knob (241).

[0089] To fill the stopper (20), the lid (B2) must be placed on the housing (A2), then the product must be introduced into the reservoir (R2) via the sleeve (232) of the lid. This is the situation shown in FIG. 7A. The rod (24), provided with the clip (25), is then introduced into the reservoir via the opening (231) and the sleeve (232) of the lid, until its lower end (242) enters the sleeve (222) of the housing and the anti-extraction shoulder has come out of the sleeve (232). The penetration of the rod (24) into the stopper is limited by the clip (25) coming in contact with the outer face of the upper radial wall (23) that forms the lid. It would also be possible to fill the housing first, and then arrange the lid and the rod.

[0090] A third embodiment is a variant of the previous example. The stopper (30) is constituted by a housing (A3), a lid (B3) and a rod (34) retained by a removable clip (35). All these parts have substantially the same characteristics as the corresponding parts of the stopper (20). The difference resides in the fact that the lower end (342) of the rod (34) is provided with means for closing the opening (321) and the sleeve (322) of the housing (A3) instead of the membrane (223). To this effect, the rod (34) carries two seals (343, 346). The first seal (343) is used, as in the example of the stopper (20), to ensure sealing of the reservoir in the area of the sleeve (332) that surrounds the opening (331) of the lid when the rod is in the high position. The second seal (346) ensure sealing of the reservoir in the area of the sleeve (322) that surrounds the opening (321) of the housing (A3). It is placed below the axial recess or recesses (344) that serve for discharging the product when the reservoir is open, so that, in the high position of the rod, the second seal bears against the inner wall of the housing sleeve (322), while in the low position of the rod, this seal is located outside the sleeve (322), the recess or recesses (344) opening at their lower ends out of the reservoir, below the sleeve (322), and at their upper ends into the reservoir, above said sleeve (322), thus providing one or more outlet openings (328).

[0091] As for the stopper (20), the rod could have a narrowing of its transverse cross-section instead of the recess or recesses (344). The second seal (346) must be placed below the narrowing.

[0092] To fill the stopper (30), it is necessary to form the reservoir by assembling the housing (A3) and the lid (B3), to introduce the rod into the opening (331) of the upper radial wall (33) so that its free end is located inside the reservoir (R3), but at a distance from the opening (321) of the lower radial wall (32). The stopper with the partially introduced rod is then turned over so that the sleeve (322) of the housing (A3) is located at the top. This corresponds to the position shown in FIG. 10A. The radial (horizontal) cross-section of the rod (34) between the first seal (343) and the axial recesses (344) or the narrowing is identical or only slightly less than the radial (horizontal) cross-section of the sleeve (332) of the lid (B3). Thus, the opening (331) of the lid (B3) is closed by the rod and the product cannot escape through this opening (331). When filling is completed, the rod with the clip (35) is completely pushed down into the stopper (30) until the clip comes in abutment against the lid (B3). In this position, called high position or closed position, shown in FIG. 10B, the lower end (342) of the rod provided with the second seal (346) is located in the sleeve (322) of the housing while the first seal (343) is located in the sleeve (332) of the lid (B3), so that the two sleeves are closed in a sealed manner. The rod is dimensioned so that the end face at the lower end of the rod is approximately aligned with the free end of the sleeve (332) of the housing when the rod is in the high position.

[0093] To release the product contained in the reservoir (R3), the clip (35) (see FIG. 11B) must be removed, as for the stopper (20), and the knob (341) of the rod must be pushed down toward the lower radial wall (32) until the lower side of the knob (341) comes to abut against the outer face of the upper radial wall (33) (see FIG. 11C). As for the stopper (20), the rod can be provided with one or more axial recesses (345) between the knob (341) and the first seal to allow air to enter the reservoir (R3) when the outlet opening (321) is open.

[0094] In a fourth embodiment, the stopper (40) is constituted by a housing (A4) and a piston (B4). The housing (A4) is constituted essentially by the cylindrical wall (41) and the rim (412). The lower edge of the cylindrical wall is located in a radial plane. The upper edge of the cylindrical wall (41) has two identical and symmetrical sets of three steps. To this effect, it is divided into two identical and symmetrical sections. Each section is divided into three sectors in which the cylindrical wall has, in each case, a different height. In the first sectors (414), the cylindrical wall has its maximum height. The rim (412) is fixed to the edge of the cylindrical wall in the area of these two sectors (414). The rim extends radially and outwardly from the cylindrical wall. In the second sectors (415), the cylindrical wall has a slightly smaller height forming a second step. In the third areas, located between the first and second sectors, the third step is constituted by the bottom of a notch (41 6). This third step is even lower that the second formed by the edge of the cylindrical wall in the area of the second sectors (414). The angular dimension of the first and second sectors is substantially identical, while that of the third sector is preferably significantly smaller.

[0095] The piston (B4) is constituted by a first radial wall, called lower radial wall (42), and a second radial wall, called upper wall radial (43), the two radial walls (42, 43) being connected to each other by a connecting rod (44), reinforced by four vertical fins in the present example. The lower radial wall (42) is extended at its periphery by a flange (425) directed downwards, while the upper radial wall (43) is extended at its periphery by a flange (435) directed upwards. The diameter of the radial walls (42, 43) and their flanges (425, 435) corresponds substantially to the inside diameter of the cylindrical wall (41). If the materials used allow it, the dimensions of the radial walls and the flanges are chosen so that they are pressed against the inner face of the cylindrical wall and ensure sealing directly. It is also possible, as provided in this example, that the diameter of the radial walls plus their flanges is slightly less than the inside diameter of the cylindrical wall. In this case, each of the flanges can be provided with an annular seal (426, 436) which is pressed against the inner face of the cylindrical wall (41) and thus ensures sealing.

[0096] In addition, the piston (B4) is provided with an actuation knob (437) with which it is possible to rotate the piston (B4) within the housing (A4). This actuation knob (437) is constituted by a vertical plate fixed to the upper face of the upper radial wall (43) and the inner face of the corresponding flange (435). The height of the plate is greater than that of the flange, so that it protrudes vertically above it. In its portion located above or in the area of the flange, the plate extends radially beyond the flange, so as to form two guide elements (438). The dimensions of these guide elements are selected so that said guide elements can be supported on the upper edge (414, 415, 416) of the cylindrical wall (41) while being able to enter the opening (93) of the container to be closed. In practice, the length of the plate forming the knob in the area of the guide elements is between the inner diameter of the cylindrical wall and the diameter of the opening to be closed (93). It is actually preferable that this length be less than the outer diameter of the cylindrical wall so that the guide elements (438) do not protrude from the envelope of the stopper defined by the outer face of the cylindrical wall.

[0097] The piston (B4) can take three distinct positions inside the housing (A4). In a first position, called filling position, the piston is placed inside the housing with the lower radial wall (42) and its flange (425) located inside the cylindrical wall at a distance from the lower edge, the upper radial wall (43) being placed inside the cylindrical wall at about mid-height of the notches (416) and the guide elements (438) being supported on the rims (412) or being above these rims (412). In this position, the reservoir (R4) is not fully closed, because the upper radial wall is located above the bottom of the notches (416), thus leaving access to the reservoir as shown in FIG. 14A. It is therefore possible to fill the reservoir (R4).

[0098] After filling, the piston (B4) is rotated so that the guide elements (438) are located above the second sectors (415). As soon as the guide elements (43 8) have left the rims (412) located in the first sectors, it is possible to push the piston down until the guiding means come to abut against the edge of the cylindrical wall in the second sectors (415), that is to say, on the second step. In this second position, called storage position, shown in FIG. 14B, the lower radial wall (42) and its flange (425) are located in the area of the lower edge of the cylindrical wall (41) and the upper radial wall (43) is located within the cylindrical wall, below the notches (416). More specifically, the annular seal (426) located on the flange (425) of the lower radial wall (42) is located in the vicinity of, and slightly above, the lower edge of the cylindrical wall. Similarly, the annular seal (436) located on the flange (435) of the upper radial wall (42) is located in the vicinity of, and below, the bottom of the notches (416). In the storage position, the reservoir (R4) is sealed by two annular seals (42 6, 436), which are pressed against the inner face of the housing (A4).

[0099] To prevent the piston (B4) from being removed from the housing (A4), it is preferable to provide a retaining shoulder (427) on the flange (425) of the lower radial wall. In the storage position, this shoulder is located outside the housing (A4). It is thus impossible to move the piston from the storage position to the filling position, because the shoulder (427) comes to abut against the lower edge of the housing (A4) and prevents the upward movement of the piston. Similarly, it is impossible to empty the reservoir by mistake, because the guide elements abut against the second steps, thus preventing a downward displacement of the piston.

[0100] To empty the reservoir (R4), it is necessary to again rotate the piston (B4) so as to align the guide elements (438) with the notches (416) and then push the piston down so that the guide elements enter these notches. In this position, the lower radial wall and its flange are located outside the housing, below its lower edge, while the upper radial wall is located inside the housing (A4). The product contained in the reservoir can flow through the annular slot (428) formed between the lower edge of the housing and the upper face of the lower radial wall. To facilitate the flow of the product, it is preferable that the upper face of the lower radial wall (42) is slightly convex, dome-shaped, or conical.

[0101] In this fourth embodiment, the lower radial wall performs the function of means for closing the outlet opening (428) and thus the reservoir, and the rod (44) associated with the knob (437) forms the opening means. The slot formed between the lower edge of the cylindrical wall (41) and the lower radial wall (42) constitutes the outlet opening. The pressure exerted on the knob (437) can be applied manually by the operator or automatically by the dialysis machine.

[0102] In the embodiments shown in the figures, the stopper and its component parts have, except for a few details, a rotational symmetry around an axis parallel to the direction of insertion into the opening that it is intended to close. In other words, their radial (horizontal) sections, that is to say, perpendicular to the direction of insertion, have substantially the shape of a circle. Yet it would of course be possible to give another shape adapted to the opening to be closed (93) at least to the cylindrical portion (11) and the radial walls (12, 13), for example a transverse cross-section that is elliptical, triangular, rectangular, etc. In the case of the fourth embodiment, the transverse cross-section of the outer face of the cylindrical wall is not necessarily round.

[0103] The upper and lower radial faces are not necessarily flat and may deviate from a plane strictly perpendicular to the insertion axis. In particular, it can be seen with the example of the fourth stopper (40) that the lower radial wall is slightly conical. Thus, the term radial must not be taken literally, that is to say, perpendicular, but in the more general sense, that is to say, the walls considered can be simply oblique with respect to the cylindrical wall.

[0104] The stopper is used as follows.

[0105] In a first stage, the reservoir of the stopper is filled with the intended component or group of components. In general, it is filled with at least one acid which may be solid, such as citric acid, or liquid, such as acetic acid or hydrochloric acid. Once closed, the stopper can be stored and transported safely.

[0106] In a second stage, the container composed of a connector (9) and a pouch or a cartridge (not shown) is filled, through its filling opening (93), with another component or group of components of the composition of the dialysis solution. In general, notably, a solid concentrate containing glucose will be used. Once filling of the container has been completed, the filling opening (93) is sealingly closed with the previously filled stopper. The container thus closed can now be distributed to users, in general, hospitals or dialysis centers.

[0107] The container filled with a stopper can now be used in a dialysis machine.

[0108] To this effect, in a third stage, the container is connected to a dialysis machine, for example, by introducing its connecting portion or portions (91, 92) into the corresponding ports of the dialysis machine.

[0109] The opening of the reservoir (R1, R2, R3, R4) can be performed before, during or after connecting the container to the dialysis machine. The actuation of the opening means produces the opening through which the contents of the reservoir will be able to flow into the pouch or cartridge. The actuation of the opening means can be performed automatically by the dialysis machine after the container has been connected to the machine, or manually by the operator before or after the container has been connected. When the dialysis machine has a cover which is folded down onto the top of the connector in place to maintain the container during dialysis, this cover can also be used to actuate the opening means.

[0110] In a last step, once the contents of the reservoir have flowed into the container and the container has been connected to the dialysis machine, the solution-forming liquid can be introduced into the container and the concentrated solution thus formed is drawn and taken into the dialysis machine, as would be the case with a traditional concentrated solution.

[0111] It may be useful in some cases to let air come into or out of the pouch or cartridge, for example, when water is introduced or when the solution is drawn. To this effect, several solutions have already been mentioned. For example, one of the introduction or extraction lines can serve as air inlet, or a third line dedicated to the passage of air can be provided in the connector (9). In the second and third embodiment of the stopper of the invention, recesses (245, 345) arranged at the top of the rods (24, 34) can be provided to allow air to circulate between the outside and the inside of the container or the cartridge via the stopper. In the case of the first embodiment, it is possible to provide a venting opening (O1, O2) in the upper radial wall (13) of the piston (B1), outside the second cylindrical wall (131). This solution is schematically shown in FIGS. 15A-15B and 16A-16B. The cylindrical wall (131) of the piston (B1) is then provided with a sealing rib (N1, N2) which bears sealingly against the inner face of the cylindrical wall (11) of the housing (A1). The rib can extend in the area of the free end of the piston (FIG. 16A-16B) or it can be substantially radial (FIG. 15A-15B). Thus, when the piston (A1) has not yet been pushed down, the opening brings only the annular portion comprised between the two cylindrical walls (11, 131), the upper radial wall (13) and the sealing rib (N1, N2) in contact with the outside. Thus, the reservoir (R1) is isolated from the outside by this sealing rib. After the piston (B1) has been pushed down into the housing (A1), the free end of the piston comes to tear the lower radial wall (12) of the housing (A1) and the rib (N1, N2) comes out of the housing (A1). An air passage is thus produced between the opening (O1, O2), the annular portion between the two cylindrical walls (11, 131) and the outlet opening (128). This air passage is represented schematically by a dashed line. It allows entry or exit of air according to needs. The opening (O1, O2) can be connected to a source of purified or sterile air or it can be open to ambient air.

[0112] In an alternative embodiment of this venting opening, not shown, which is applicable to the four embodiments, it can be provided that the venting opening extends through the upper radial wall (13, 23, 33, 43) and opens directly into the reservoir (R1, R2, R3, R4). In this case, the venting opening must be closed by a removable cap that can be removed if needed at the time of actuating the means for producing the outlet opening.

[0113] The use of the stopper provided with a reservoir to close the introduction opening makes it possible to provide to dialysis patients an acidic concentrate in which the majority of components are solid. Because of the separation of the component s, the concentrate is stable. In addition, at most, only the contents of the reservoir of the stopper are in liquid form. Therefore, the operator only manipulates a container containing the necessary components for the solution, but not the solution-forming liquid. Thus, these containers are much lighter and easier to handle. Storage of these containers requires less space.

[0114] From an industrial point of view, it is possible to manufacture empty containers, with their filling channel open, in a first industrial site.

[0115] Filling of the stoppers can be performed in a second industrial site.

[0116] This way, empty containers and filled stoppers can be delivered to filling centers distributed around the world. In these centers, the containers are filled and the stoppers are put in place in the filling channels. The filled containers only need to be delivered to local markets.

[0117] This procedure can significantly reduce transportation and handling costs, because the distances travelled by the filled containers are limited. Only empty containers (thus, light and compact) and stoppers travel great distances.

TABLE-US-00001 List of references: A1 A2 A3 A4 Housing B1 B4 Piston B2 B3 Lid R1 R2 R3 R4 Reservoir 10 20 30 40 Stopper 11 21 31 41 Cylindrical wall 111 211 311 Annular seal 112 212 312 412 Rim 213 313 Annular groove 414 First sector 415 Second sector 416 Third sector/notch 12 22 32 42 Lower radial wall 221 321 Housing opening 222 322 Sleeve surrounding the housing opening 223 Closure membrane 124 Weakness zone 425 Lower flange 426 Annular seal 427 Annular shoulder 128 228 328 428 Outlet opening 13 23 33 43 Upper radial wall 131 Second cylindrical wall 231 331 Lid opening 132 Safety tab 232 332 Sleeve surrounding the lid opening 233 333 Cylindrical flange 234 334 Annular rib 435 Upper flange 436 Annular seal 437 Knob 438 Guide elements 24 34 44 Rod 241 341 Knob 242 342 Lower end of the rod 243 343 First seal 244 344 Product outlet axial recesses 245 345 Air intake axial recesses 346 Second seal 247 Anti-extraction annular shoulder 25 35 Clip 9 Connector for container 91 Connecting portion 92 Connecting portion 93 Opening to be closed O1/O2 Venting opening N1/N2 Sealing rib