Abstract:
A connector for connecting a container with a fluid preparation device for preparing a fluid, in particular a container with a concentrate for the preparation of dialysis fluid, as well as the combination of the connector, the corresponding container and the fluid preparation device. In order to simplify the handling during both the manufacturing process of such containers and the connection of such containers to the fluid preparation devices, the connector connects a first and second fluid line of the container with a third and fourth fluid line of the fluid preparation device with two laterally spaced-apart mounting elements which each incorporate one of two orifices terminating the first and second fluid lines.

Description:
RELATED APPLICATIONS 
       [0001]    This is a continuation application of U.S. Ser. No. 12/923,967, filed Oct. 18, 2010, which was a continuation application of U.S. Ser. No. 11/798,699, filed May 16, 2007, now U.S. Pat. No. 7,828,788, which was a continuation application of U.S. Ser. No. 10/384,732, filed Mar. 11, 2003, now U.S. Pat. No. 7,223,262, and hereby claims the priority thereof to which it is entitled. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The invention relates to the field of connectors for connecting a container with a fluid preparation device for preparing a fluid. The invention also relates to such containers and fluid preparation devices, in particular to dialysis devices. 
         [0004]    2. Description of the Related Art 
         [0005]    Most hemodialysis devices used for routine treatment prepare the required dialysis fluid themselves by a fluid preparation part which is contained in the device and where the mixing of adequate concentrates with water takes place. These concentrates are commonly distributed in liquid form and filled in canisters. Both the handling and the transportation of such canisters filled with fluid concentrates pose various problems. Special and rather spatial connectors are necessary on the dialysis device to couple such canisters so that the device can suck the required concentrate. During exchange of a canister, fluid can be spilled. Special chambers for accommodating or even rinsing the connector during any periods when no canister is connected may be required. As far as the weight is concerned, it is primarily only water which is delivered from the manufacturer to the patient. Furthermore, the empty canisters represent an environmental problem as only special material with certain blocking and stability properties should be used. 
         [0006]    It is also known to provide concentrates, for instance in a clinic, from a central preparation unit to various treatment sites by an installed piping network. Though this simplifies the working load at the treatment sites in these clinics, it is obvious that such a piping network is expensive, both for installation and maintenance, and not applicable for more flexible conditions. 
         [0007]    It is also known to use, at least for some ingredients of the dialysis fluid, a powdered or granulated solid concentrate such as bicarbonate. U.S. Pat. No. 5,540,265 describes such a system with a bag containing a concentrate and having a plug component. On the dialysis device there is a complementary plug component by which a flow connection for a first and a second flow path with the interior of the bag may be established. Water is introduced into the bag by the first flow path. Diluted and thus prepared bicarbonate fluid is extracted by the second flow path. 
         [0008]    The plug component has a coaxial design for the two flow paths. The complementary plug component on the dialysis device therefore has a rather sophisticated design which in turn requires elaborate solutions to make routine rinsing and disinfection of this part of the dialysis device possible. Furthermore, as the plug component on the bag has a circular design the manufacturing process of such a bag affords special processes as the plug component is usually welded into a complementary hole in a side wall of the bag. More simple techniques assessing the bag only from the top are hence not applicable. 
       SUMMARY OF THE INVENTION 
       [0009]    It is therefore an object of the invention to provide a connector for a container to be coupled to a mating connector on a fluid preparation device such as a dialysis device which considerably simplifies the handling during the connection procedure, the manufacturing process of the container and the rinsing and disinfection of the mating connector part on the fluid preparation device. 
         [0010]    It is also an object of the invention to provide a corresponding container. 
         [0011]    Furthermore, it is an object of the invention to provide a fluid preparation device with a corresponding mating connector. 
         [0012]    These objects of the invention are solved by a connector for connecting fluid lines with a first connector part providing a first orifice for connecting a first fluid line to a third fluid line, a second connector part providing a second orifice for connecting a second fluid line to a fourth fluid line, and a mounting means enabling the connection of the first and second connector parts to mating parts of a mating connector. The mounting means comprises two laterally spaced-apart mounting means enabling connection to two equally laterally spaced-apart mounting means of the mating connector, with each of the two mounting means incorporating one of the two orifices. The present invention further includes the combination of a connector as just described with a container having a containment portion. 
         [0013]    The objects of the invention are also solved by a fluid preparation device including a source for a flushing fluid which is connected to a flushing fluid line, a prepared fluid line for fluid to be prepared, a container having an interior filled with a fluid medium, a mounting connector part having first and second mating mounting means suitable for mounting and connecting the container such that the flushing fluid line and the prepared fluid line are in fluid communication with the interior of the container, and a connector. The connector has a first connector part providing a first orifice for connecting a first fluid line to the flushing fluid line, a second connector part providing a second orifice for connecting a second fluid line to the prepared fluid line, and two laterally spaced-apart mounting means for connecting the first and second connector parts to the mounting connector part, with each of the two mounting means incorporating one of the first and second orifices. 
         [0014]    The concept of the invention is based on the observation that by separating the mounting means which comprises both fluid line connector parts for the two fluid lines to be connected to two fluid lines of the fluid preparation device, into two laterally spaced-apart mounting means, each incorporating the orifices of one of the two connector parts, it is possible to set up a connector system which significantly simplifies the handling and manufacturing processes. With the aid of the inventive concept it is in particular possible to design a container to be connected to a fluid preparation device, which is mounted in a suspended fashion with the connector parts being used at the same time in a hook-like fashion at the uppermost point of the container to realize an optimum stability of the mounted container. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0015]    These and other advantages of the invention will become more apparent from an embodiment which is now described as an example by the aid of the drawings. 
           [0016]      FIG. 1  shows a perspective view of an embodiment of the connector according to the invention with a boat-like cross-section. 
           [0017]      FIG. 2  shows a first sectional drawing of the connector shown in  FIG. 1 . 
           [0018]      FIG. 3  shows a second sectional drawing taken along line A-A of  FIG. 2 . 
           [0019]      FIG. 4  shows an embodiment for a container according to the invention using the connector shown in  FIGS. 1 to 3 , and a part of an embodiment of the fluid preparation device according to the invention, which is suitable for mounting the container, a lid of that part being in a first position. 
           [0020]      FIG. 5  shows the same arrangement as  FIG. 4 , the container being mounted. 
           [0021]      FIG. 6  shows a first sectional view of that part of the fluid preparation device with the container being mounted, the lid being in a second position. 
           [0022]      FIG. 7  shows a second sectional view of that part of the fluid preparation device without the container being mounted, the lid being in a third position. 
           [0023]      FIG. 8  shows removal of a flap-like seal from the container prior to use thereof. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0024]    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. 
         [0025]    In  FIG. 1  an embodiment of a connector according to the invention is shown in a perspective view. The connector  1  has two bar-like, laterally spaced-apart connecting parts or mounting means  2  and  4 . Such mounting means may easily be mounted to a mating mounting means by insertion in an axial direction. The interior of the mounting means  2  and  4  is hollow, thus defining first and second orifices  3  and  5 . 
         [0026]    The connector  1  has a boat-like cross-section with a wide middle part  6  and two wing-like projections  7  and  8  on opposing sides of the middle part  6 . The boat-like cross-section simplifies the joining of the connector to a containment portion of a container like a flexible tube bag considerably, as is known in the art of manufacturing flexible bags. For welding purposes there may therefore be provided a rip structure  19  at the lower end  16  of the connector  1 . 
         [0027]    The middle part  6  of the boat-like cross-section shows a fifth orifice  11  which extends from the upper end  17  to the lower end  16 . The orifice  11  may be used for prefilling the containment portion to be joined to the connector during the manufacturing process with a substance. 
         [0028]    The mounting means  2  and  4  protrude from the wing-like projections  7  and  8  by protrusions  28  and  29  in a direction which is perpendicular to the axes of the mounting means  2  and  4  and thus also to the axes of the orifices  3 ,  5  and  11 , which are all parallel. In the embodiment shown in  FIG. 1 , the protrusions  28  and  29  are tangential to one side of the wing-like projections  7  and  8 . 
         [0029]    Furthermore, a first end  13  of a handle  12  is joined to the first mounting means  2  and a second end  14  of the handle  12  is joined to the second mounting means  4 . To ease the use of the handle  12 , the ends  13  and  14  may comprise flexible film joints. 
         [0030]    The connector  1  also comprises a ledge  15  which joins the second mounting means  4  with the middle part  6  of the connector  1 . This ledge  15 , as will be outlined below, serves as a counterpart for a detector means at the mating connectors site for confirming the correct mount of the connector. 
         [0031]    In  FIG. 2  a sectional view of the container  1  is shown where the middle part  6  and the wing-like projections  7  and  8  are cut along their middle, and the view is from the back as seen in  FIG. 1 . The connector  1  extends from the lower end  16  to the upper end  17 . In the middle part, the continuous orifice  11  for enabling an easy prefilling of the containment portion to be joined to the lower end  16  of the container is seen. 
         [0032]    In the first wing-like projection  7  there is also a continuous third orifice  9  and in the second wing-like projection  8  a continuous fourth orifice  10 . Though the third and fourth orifices  9  and  10  have a varying cross-section along their extensions from the lower end  16  to the upper  17  of the container  1 , this has no influence on the fact that a fluid communication is established along these extensions. The third orifice  9  extends to a first distribution chamber  20  and the fourth orifice  10  to a second distribution chamber  21 . 
         [0033]    As can be seen in  FIG. 1  the distribution chambers  20  and  21  are in fluid communication with the first and second orifices  3  and  5  by slots  22  and  23 , respectively. By mounting the connector  1  in a mating mounting means to be described below, fluid communication is thus established from the first orifice  3  to the third orifice  9  which hence constitutes a first fluid line, and from the second orifice  5  to the fourth orifice  10  which constitutes a second fluid line. 
         [0034]      FIG. 3  shows a further sectional view along the line A-A as indicated in  FIG. 2 . In this view the protrusions  28  and  29  of the two mounting means  2  and  4 , and thus the first and second orifices  3  and  5  in a direction perpendicular to the vertical extension of the wing-like projections  7  and  8  and the middle part  6  of the connector  1 , are displayed more clearly. 
         [0035]    In an embodiment of a container according to the invention, the connector  1  shown in  FIGS. 1 to 3  is representing the connector portion, the lower end  16  to be joined to a containment portion of the container. For this purpose the upper end  17  is sealed along the circumference  26 —which is also encircling and thus sealing the fifth orifice  11 —by a flexible sheet  18  by welding or similar known joining techniques. It is worth noting that due to the design of the connector, the flow paths for the first and second fluid lines are not blocked by this seal. The flexible sheet  18  is indicated in  FIG. 2 . 
         [0036]    This embodiment of the container is shown in  FIG. 4 . The containment portion  31  of the container  30  is made from a tube bag which is sealed at the lower end  32  and joined by welding or similar techniques in a leak-proof manner at the upper end  33  to the lower end  16  of the connector  1 . In the embodiment shown in  FIG. 4 , the container  30  is furthermore prefilled with a powdered concentrate  34  of a substance to be dissolved for final usage. The substance may be provided in any other condition, solid or fluid, whatever may be useful for the particular purpose. 
         [0037]    For maintaining sterility before usage, the lower ends  24  and  25  of the orifices  3  and  5  may be sealed in an appropriate way so that the interior of the container  30  is completely sealed to the exterior. As an example, a single flap-like seal  27  is shown in  FIG. 8  which is sealing both orifices  3  and  5 . The seal  27  may be removed by a user before usage by peeling off the seal as shown in  FIG. 8 . 
         [0038]    Furthermore, tubes and/or filters (not shown) may be provided in the container  30  which are placed in the first and/or second fluid line in order to filter passing fluid flowing in and/or out of the bag and/or extend the lines to a particular site within the containment portion  31 . If it is desired to withdraw a saturated solution of a substance to be dissolved, it may prove useful to introduce the flushing and hence dissolving fluid, like water, close to the upper end  33  of the containment portion  31  and to withdraw the saturated solution close to the lower end  32  of the containment portion  30 . 
         [0039]    In  FIG. 4  there is also shown a part  50  of an embodiment for a fluid preparation device according to the invention which has mating first and second mounting means  53  and  54  for mounting the connector  1  and thus container  30 . These mating first and second mounting means are formed by first and second insertion chambers  53  and  54 , respectively, which have a complementary cross-section such that the first and second bar-like mounting means  2  and  4  can be mounted by insertion into these chambers. Any cross-section may be used, but a circular cross-section as shown in this embodiment is advantageous in view of improved rinsing and disinfection properties. 
         [0040]    The first insertion chamber  53  is in fluid communication with a third fluid line  51 , the flushing fluid line, which is connected to a flushing fluid source (not shown) for the delivery of flushing fluid. This flushing fluid is required during use of the container  30  in order to prepare the prepared fluid from the prefilled substance and the flushing fluid—the latter being in most cases simply water. Correspondingly, the second insertion chamber  54  is in fluid communication with a fourth fluid line  52 , the prepared fluid line, which enables the delivery of the prepared fluid to a place where it is required. This may still be within the fluid preparation device or by means of a suitable outlet for the delivery to somewhere else. 
         [0041]    The part  50  of the fluid preparation device also comprises a detector means  58  which in this embodiment is a mechanical microswitch. Upon mounting the container  30  and thus the connector  1 , the ledge  15  presses the switch  58  which by an electronic evaluation circuit (not shown) of the fluid preparation device enables the device to confirm the correct mount of the connector  1 . It may be possible that this evaluation circuit causes any actuators to block the flow of any flushing fluid into the first insertion chamber  53  until such confirmation has taken place. 
         [0042]    The part  50  of the fluid preparation device further comprises a lid  59 . The lid  59  is turnable around a joint  65  from a first open position which is shown in  FIG. 4 , to a third closed, and preferably locked, position which will be described below. Between the first and the third positions, the lid is arrestable, preferably lockable, in a second position with the container  30  being mounted, as will also be explained below. The lid  59  has first and second closure parts  60  and  61 , respectively, which are suitable to close the first and second insertion chambers  53  and  54 , respectively, when the lid  59  is in the third position. 
         [0043]      FIG. 5  shows the same view as  FIG. 4  with the connector  1  and thus the container  30  being mounted to the part  50  of the fluid preparation device. The first and second mounting means  2  and  4  are inserted in the first and second insertion chambers  53  and  54 , respectively. Furthermore, there are two proximity detectors  63  and  64  on the part  50  which detect the presence of the lid  59  in either the second position or the third position. These proximity sensors may be non-mechanical sensors like Hall sensors which notice the close position of certain parts of the lid  59 . These sensors may as well comprise mechanical switching means which are actuated by movable counterparts (not shown) of the lid which at the time serve to lock the lid  59  in the second or third position. 
         [0044]      FIG. 6  shows a first sectional view of the arrangement shown in  FIG. 5  with the lid  59  being in the second position, arresting the connector  1  in its mounted position by pushing with the closure parts  60  and  61  onto the connector  1 . The sectional view is taken along the flushing fluid line  51  and the first insertion chamber  53 , looking from left to right in  FIG. 5 . The prepared fluid line  52  and the second insertion chamber  54  have a symmetric design. 
         [0045]    Within the first insertion chamber  53  there is first male connector element  55  which terminates the flushing fluid line  51  within the first insertion chamber  53 . The first male connector element  55  is joined to the housing of part  50  with a flexible sealing and compensation element  57  which may be made of any suitable material, e.g. rubber. The sealing and compensation element  57  enables movements of the first male connector element  55  relative to the housing in order to compensate tolerances which may exist for the relevant counterparts of the connector  1 . 
         [0046]    In the arrangement displayed in  FIG. 6 , the first orifice  3  and hence the first fluid line of the connector  1  and container  30  are now in fluid communication with the flushing fluid line  51 . The orifice  3  is limited by first sealing lips  66  at the lower circumference of the first mounting means  2 . The sealing lips  66  may easily be created by injection molding. The lips  66  assure a leak-proof connection to the first male connector element  55  which they encompass at its outer circumference. 
         [0047]    The first mounting means  2  is inserted into the first insertion chamber  53  until a first step-like projection  69  of the first mounting means  2  is touching the housing of the part  50  of the fluid preparation device. 
         [0048]    From the first insertion chamber  53  there also branches off a fifth fluid line  62 . When the connector  1  is mounted, this fifth fluid line  62  will be sealed by the first sealing lips  66 , i.e., there is no fluid communication to the connected first and third fluid lines, the third fluid line being the flushing fluid line  51 . 
         [0049]    For the connection of the second and fourth fluid lines there are corresponding elements, i.e., a second male connector element, a second sealing and compensation element, second sealing lips, a second step-like projection and a branching sixth fluid line. 
         [0050]    The purpose of the fifth and sixth fluid lines becomes apparent from  FIG. 7 . This figure shows a second sectional view of the part  50  of the fluid preparation device. It differs from  FIG. 6  by the fact that no connector  1  is mounted and that the lid  59  is in the closed, third position. The first insertion chamber  53  is now closed by the first closure part  60  which is a part of the lid  59 . The closure is sealed by sealing means  67  on the outer circumference of the first closure part  60 , which here is accomplished by an o-ring gasket. On the inner side of the first closure part  60  there is a first opening  68  which has a larger diameter than the outer diameter of the first male connector element  55 . 
         [0051]    In this configuration, the fluid lines of the part  50  of the fluid preparation device may easily be rinsed with any fluid such as water or disinfection fluid. As the second closure part  61  is sealing the second insertion chamber  54  in a similar way, the rinsing fluid may be provided by the third fluid line, i.e. the flushing fluid line  51 . The flushing fluid then enters the first insertion chamber  53  and leaves the chamber  53  via the fifth line  62 . In this embodiment the fifth and sixth lines are joined (not shown). The rinsing fluid hence enters the second insertion chamber  54  by the sixth fluid line and leaves it by the fourth fluid line, i.e., the prepared fluid line  52 . By this configuration an easy and effective rinsing and/or disinfection of all relevant parts of the fluid preparation device in the mating connector area is accomplished. Any parts which are above the gasket  67  are not reached by the rinsing fluid, but these parts will not be part of the fluid path if a connector  1  is connected either. 
         [0052]    The connector  1  or container  30 , respectively, may be designed as a disposable article for single-use purposes. Hence special solutions for their disinfection have not to be found. In this case a sensitive part like the sealing lips  66  is automatically exchanged from one use to another without affording any extra parts or expensive maintenance procedures. 
         [0053]    The detector means  63  and  64  sense the lid  59  in the second or the third position. The electronic evaluation circuitry of the fluid preparation device monitors the signals provided by these detector means in order to confirm an expected position of the lid  59  during specific modes of the fluid preparation device like disinfection or online fluid preparation. 
         [0054]    It is worth noting that the boat-like cross section of the connector  1  represents a preferred embodiment. Any other shape of the connector which still meets the concept of the invention as outlined herein would nevertheless enable an easy handling of the connector system during use. As is apparent from  FIGS. 4 to 7 , the shape of this part of the connector hardly has any influence on the connection steps themselves. 
         [0055]    The invention is hence providing easy to handle and reliable components for a fluid preparation system consisting of a container with a special connector and a fluid preparation device. The container may be prefilled with a substance, but also applications are possible where an initially empty container is used which will be filled and/or emptied during use. The container can be of any type, rigid or flexible. A flexible bag represents however a preferred embodiment. 
         [0056]    The components of the inventive system are particularly useful in the medical field where the handling is especially sensitive to sterility conditions. At the same time, the invention provides inexpensive solutions which are not of lesser interest. The invention has proven particularly useful in the field of dialysis where the fluid preparation device is part of the dialysis device. The prepared fluid may represent only a part of the complete dialysis fluid like bicarbonate, or the complete dialysis fluid. It may be applied to any type of dialysis, such as hemodialysis or peritoneal dialysis. 
         [0057]    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.