AU2008200276B2 - Concentrate bag connector - Google Patents

Description

Australian Patents Act 1990 - Regulation 3.2 ORIGINAL COMPLETE SPECIFICATION STANDARD PATENT Invention Title: Concentrate bag connector The following statement is a full description of this invention, including the best method of performing it known to me: P/00/01I CnC1 1 Concentrate bag connector The invention relates to the field of connectors for connecting a container with a fluid 5 preparation device for preparing a fluid. The invention also relates to such containers and fluid preparation devices, in particular to dialysis devices. 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 10 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 concentrate are posing 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 may 15 be spilled. Special chambers for accommodating or even rinsing the connector during any periodes 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. 20 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 25 conditions. It is also known to use at least for some ingredients of the dialysis fluid a powdered or granulated solid concentrate such as bicarbonate. US 5,540,265 describes such a system with a bag containing a concentrate and having a plug component. On the dialysis 30 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.

C:\NRPonb\DCC\CAB\3594446_1.DOC13/042011 -2 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. According to a first aspect of the present invention there is provided a container with a containment portion and a connecting portion the connecting portion comprising a connector with a first connector part providing a first orifice for connecting a first fluid line in the container to a third fluid line, a second connector part providing a second orifice for connecting a second fluid line in the container to a fourth fluid line, a mounting means enabling the connection of the first and second connector parts to mating parts of a mating connector, the mounting means comprising two laterally spaced-apart mounting means enabling connection to two equally laterally spaced-apart mating mounting means of the mating connector, wherein each of the two mounting means incorporates one of the two orifices and wherein the container is mountable 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.

C:\NRPorN\DCC\CAB\35944461. DOC. 13/04/2011 -3 According to a second aspect of the present invention there is provided a fluid preparation device with a source for a flushing fluid which is connected to a flushing fluid line, with a prepared fluid line for the fluid to be prepared, with a mounting connector part suitable for mounting and connecting a container such that the flushing fluid line and the prepared fluid line are in fluid communication with the interior of the container, wherein the mounting connector part comprises the first and second mating mounting means, that the flushing fluid line is the third fluid line and that the prepared fluid line is the fourth fluid line, wherein the first and second mating mounting means are first and second insertion chambers into which the first and second mounting means of the connector are insertable for connection and which comprise a first male connector element terminating the flushing fluid line and a second male connector element terminating the prepared fluid line. 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 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.

C:\NRonhN\CC\CAB\1594446 1.DOC-13A/W2011 -4 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. In the drawings. Figure I shows a perspective view of an embodiment of the connector according to the invention with a boat-like cross-section; Figure 2 shows a first sectional drawing of the connector shown in figure 1, 5 Figure 3 shows a second sectional drawing as defined by figure 2; Figure 4 shows an embodiment for a container according to the invention using the 5 connector shown in figures 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; Figure 5 shows the same arrangement as figure 4, the container being mounted; 10 Figure 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; and Figure 7 shows a second sectional view of that part of the fluid preparation device 15 without the container being mounted, the lid being in third position. In figure 1 an embodiment of a connector according to the invention is shown in a perspective view. The connector I has two bar-like, laterally spaced-apart mounting means 2 and 4. Such mounting means may easily be mounted to a mating mounting 20 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. 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 25 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. 30 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.

6 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 5 parallel. In the embodiment shown in figure 1, the protrusions 28 and 29 are tangential to one side of the wing-like projections 7 and 8. 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 10 use of the handle 12 the ends 13 and 14 may comprise flexible film joints. 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 15 confirming the correct mount of the connector. In figure 2 a sectional view of the container I 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 figure 1. The connector I extends from the lower end 16 to the upper end 17. 20 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. 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 25 fourth orifice 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 extents to a first distribution chamber 20 and the fourth orifice 10 to a second distribution chamber 21. 30 As can be seen in figure 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 I 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 7 first fluid line, and from the second orifice 5 to the fourth orifice 10 which constitutes a second fluid line. 5 Figure 3 shows a further sectional view along the line A-A as indicated in figure 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 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. 10 In an embodiment of a container according to the invention the connector 1 shown in figures 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 15 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 figure 2. This embodiment of the container is shown in figure 4. The containment portion 31 of 20 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 figure 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, 25 solid or fluid, whatever may be useful for the particular purpose. 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 figure 8 which 30 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 figure 8. Furthermore, not shown tubes and/or filters 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 8 and/or out 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 5 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. In figure 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 10 for mounting the connector I and thus container 30. These mating first and second mounting means are formed by first and second insertion chambers 53 and 54 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 15 improved rinsing and disinfection properties. 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 20 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 25 delivery to somewhere else. 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 a not shown electronic 30 evaluation circuit 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.

9 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 figure 4, to third, closed and preferable locked position which will be described below. Between 5 the first and the third position, 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 which are suitable to close the first and second insertion chambers 53 and 54, respectively, when the lid 59 is in the third position. 10 Figure 5 shows the same view as figure 4 with the connector I 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. Furthermore, there are two proximity detectors 63 and 64 on the part 50 which 15 detect the presence of the lid 59 in either the second 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. 20 Figure 6 shows a first sectional view of the arrangement shown in figure 5 with the lid 59 being in the second position, arresting the connector I 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 25 figure 5. The prepared fluid line 52 and the second insertion chamber 54 have a symmetric design. 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. 30 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 10 connector 1. In the arrangement displayed in figure 6 the first orifice 3 and hence the first fluid 5 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-proofed connection to the first male connector element 55 which they encompass at its outer circumference. 10 The first mounting means 2 is inserted into the first insertion chamber 53 as far 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. 15 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, that latter being the flushing fluid line 51. 20 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. 25 The purpose of the fifth and sixth fluid lines becomes apparent from figure 7. This figure shows a second sectional view of the part 50 of the fluid preparation device. It differs from figure 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 part of the lid 59. The closure is sealed by sealing means 67 on the outer 30 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.

11 In this configuration the fluid lines of the part 50 of the fluid preparation device may easily be rinsed with any fluid like water or disinfection fluid. As the second closure part 61 is sealing the second insertion chamber 54 in a similar way, the rinsing fluid 5 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 it 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 10 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 I is connected either. 15 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. 20 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 is monitoring 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 25 preparation. It is worth noting that the boat-like cross section of the connector I represents a preferred embodiment. Any other shape of the connector which still meets the concept of the invention as outlined by the claims would nevertheless enable an easy handling 30 of the connector system during use. As is apparent from figures 4 to 7 the shape of this part of the connector hardly has any influence on the connection steps themselves.

C:VRPobrIDCCCAB\3594446 1.DOC-13/042011 - 12 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. 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 is 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 like hemodialysis or peritoneal dialysis. Throughout this specification and the claims which follow, unless the context requires otherwise the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps. The reference to any prior art in this specification is not, and should not be taken as an acknowledgment or any form of suggestion that, that prior art forms part of the common general knowledge in Australia.

Claims (25)

1. Container with a containment portion and a connecting portion the connecting portion comprising a connector with a first connector part providing a first orifice for connecting a first fluid line in the container to a third fluid line, a second connector part providing a second orifice for connecting a second fluid line in the container to a fourth fluid line, a mounting means enabling the connection of the first and second connector parts to mating parts of a mating connector, the mounting means comprising two laterally spaced-apart mounting means enabling connection to two equally laterally spaced-apart mating mounting means of the mating connector, wherein each of the two mounting means incorporates one of the two orifices and wherein the container is mountable 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.

2. Container according to claim I wherein the connector has a cross-section with a wide middle section and two wing-like projections on opposite sites of the middle section and wherein each of the two mounting means protrudes from one of the two wing-like projections.

3. Container according to claim 2 wherein each of the two mounting means protrudes from one of the two wing-like projections by protrusions in a direction perpendicular to the two parallel axes of the two orifices.

4. Container according to claim 2 or 3 wherein there is a third orifice in the first wing like projection and a fourth orifice in the second wing-like projection. C:\NRPrnlDCC\CA B\3 59446 .DOC-I 3/(/2011 - 14

5. Container according to claim 4 wherein there is a fifth orifice in the middle section.

6. Container according to any one of the preceding claims wherein the connector further comprises a handle means with two ends each of which is joined to one of the mounting means.

7. Container according to any one of the claims 3 to 6 wherein the connector further comprises a ledge joining the middle section and one mounting means.

8. Container according to any one of the preceding claims wherein the containment portion comprises a bag.

9. Container according to claim 8 wherein the bag is of the type of a tube bag with one end being sealed and the other end being closed by the connector.

10. Container according to any one of the preceding claims wherein the container is filled with a dry or fluid medium (34).

11. Container according to claim 10 wherein the dry or fluid medium is an ingredient, in particular as a concentrate, of a dialysis fluid.

12. Container according to any one of the preceding claims wherein a lower end of the connector is sealed to the atmosphere by the containment portion, that an upper end of the connector is sealed to the atmosphere by a seal and that the first and second orifices are sealed to the atmosphere by a further seal.

13. Fluid preparation device with a source for a flushing fluid which is connected to a flushing fluid line, with a prepared fluid line for the fluid to be prepared, with a mounting connector part suitable for mounting and connecting a container such that the flushing fluid line and the prepared fluid line are in fluid communication with C:\NRPn\DCC\CAB\3594446_LDOC-I3/4/20l - 15 the interior of the container, wherein the container is the container according to any one of the claims I to 12, that the mounting connector part comprises the first and second mating mounting means, that the flushing fluid line is the third fluid line and that the prepared fluid line is the fourth fluid line, wherein the first and second mating mounting means are first and second insertion chambers into which the first and second mounting means of the connector are insertable for connection and which comprise a first male connector element terminating the flushing fluid line and a second male connector element terminating the prepared fluid line.

14. Fluid preparation device according to claim 13 wherein a sealing and compensation element is inserted into each of the first and second insertion chambers to seal and compensate movements of the first and second male connector elements.

15. Fluid preparation device according to the claims 13 or 14 wherein the first and second insertion chambers have parallel orientations.

16. Fluid preparation device according to any one of the claims 13 to 15 wherein the fluid preparation device further comprises detector means for detecting the presence of the connector.

17. Fluid preparation device according to any one of the claims 13 to 16 wherein it further comprises a lid for covering the mounting connector part.

18. Fluid preparation device according to claims 13 and 17 wherein the lid comprises a first closure part for closing the first insertion chamber and a second closure part for closing the second insertion chamber. C:\NRPortb\DCC\CAB\3594446 LDOC-1 3/04/201 - 16

19. Fluid preparation device according to claim 18 wherein it further comprises a fifth fluid line being in fluid communication with the first insertion chamber and thus the flushing fluid line when the first closure part closes the first insertion chamber, and a sixth fluid line being in fluid communication with the prepared fluid line when the second closure part closes the second insertion chamber.

20. Fluid preparation device according to claim 19 wherein the fifth and sixth fluid lines are joined.

21. Fluid preparation device according to any one of the claims 17 to 20 wherein the lid is movable between a first position enabling the mounting and/or removal of the connector, a second position where the mounted connector is kept in place by the lid and a third position where the first and second insertion chambers are closed and no connector is mounted.

22. Fluid preparation device according to claim 21 wherein it further comprises a lid position detector means for detecting one, some or all three positions of the lid.

23. Fluid preparation device according to any of the claims 13 to 22 wherein it is a part of a dialysis fluid preparation device and that the prepared fluid is or is a part of the dialysis fluid.

24. A container substantially as hereinbefore described with reference to the drawings.

25. Fluid preparation device substantially as hereinbefore described with reference to the drawings.