Connector, container with such a connector and fluid preparation device with a mating connector for such a container

256 348 T3

DESCRIPTION

Connector, container with such connector and fluid preparation device with mating connector for such container.

The invention describes the field of connectors for connecting a container with a device for preparing a fluid. The invention also describes such containers and fluid preparation devices, in particular dialysis devices.

Most of the hemodialysis devices used in routine treatment prepare the required dialysis fluids themselves with a part of the fluid preparation contained in the device and where the mixing of the appropriate concentrates with the water takes place. These concentrates are commonly distributed in liquid form in cans. Both the handling and the transportation of such cans filled with the concentrated fluid pose several problems. Special and also spatial connectors are necessary in the dialysis device to connect such cans so that the device can sip the required concentrate. During the exchange of a fluid from a can, it can be spilled. Special chambers used for fitting or flushing the connector, at any time, may not require any can to be attached. As far as weight is concerned, it is mainly only water that is supplied from the manufacturer to the patient. On the other hand, empty cans represent an environmental problem as the only special material, so they should be used with certain blocking and stability systems.

It is also known to provide concentrates, for example in a clinic, from a central preparation unit to various treatment sites via an installed pipe network. Although this simplifies the workload in the treatment places of these clinics, it is obvious that such a network of pipes is expensive, both to install and maintain, not being applicable for more flexible conditions.

It is also known to use, at least for some dialysis fluid ingredients, a powdered or granulated solid concentrate such as bicarbonate. US 5,540,265 describes such a system with a bag that contains a concentrate and has a plug component. In the dialysis device there is a complementary plug component by which a flow junction can be established for a first and a second flow path with the interior of the bag. The water enters the bag through the first flow path. The bicarbonate thus diluted and prepared is extracted by the second flow path.

The plug component has a coaxial design for the two flow paths. The complementary plug component in the dialysis device therefore has a rather sophisticated design which in turn requires complicated solutions to enable routine rinsing and disinfection of this part of the dialysis device. On the other hand, as the plug component in the bag has a circular design the industrial process of such a bag allows special processes when the plug component is generally welded in a complementary hole in a side wall of the bag. Simpler techniques that evaluate the bag only from the top are not applicable.

Therefore, it is an object of the invention to provide a connector for a container to be hooked to a coupling connector in a fluid preparation device such as a dialysis device that greatly simplifies the handling during the hooking process, the industrial process of the container and, rinsing and disinfecting the part of the mating connector in the fluid preparation device.

It is also an object of the invention to provide a corresponding container. Furthermore, it is an object of the invention to provide a combination of a fluid preparation device and a container with their corresponding mating connectors.

These objects of the invention are solved by the subject matter as claimed by independent claim 1, and claims 6 and 12. Various parts of the invention are the subject of additional dependent claims.

The concept of the invention is based on the observation that, separating the mounting element that comprises both parts of the fluid line connector so that the two fluid lines are connected to two fluid lines of the device for preparing the same, in two mounting means laterally spaced apart, each incorporating the holes in one of the two connecting parts, It is possible to establish a connector system that significantly simplifies handling and manufacturing processes. It is possible in particular, with the help of the ingenious concept, to design a container to be connected to a fluid preparation device, which is mounted in a suspended manner with the connecting parts used at the same time hook-shaped at the most point. container height to achieve optimum stability of the mounted container.

These and other advantages of the invention will become more apparent thanks to a representation that is now described as an example with the aid of the drawings. In the drawings, figure 1 shows a perspective view of a part of the connector according to the invention with a wedge-shaped cross section, figure 2 shows a first sectional drawing of the connector shown in figure 1, figure 3 shows a second sectional drawing as defined by figure 2, figure 4 shows a representation of a container according to the invention that uses the connector shown in figures 1 to 3, and a part of the representation of the device for preparing the fluid according to the invention, suitable for mounting the container, a cover of that part that is in the first position, figure 5 shows the same arrangement as figure 4, the container mounted, the Figure 6 shows a first sectional view of that part of the fluid preparation device with the container mounted, the lid being in the second position, Figure 7 shows a second sectional view of that part of the fluid preparation device without the container mounted, the lid being in the third position, and Figure 8 shows the container with a flap seal before use.

Figure 1 shows a representation of a

ES 2 256 348 T3 connector according to the invention in perspective view. The connector 1 has two semi-bars, laterally spaced joints of 2 and 4. Such mounting joints can be easily mounted in a mating socket in the axial direction. The interior of the joints 2 and 4 is hollow, thus defining the first and second holes 3 and 5.

The connector 1 has a wedge-shaped cross-section with a wide middle part 6 and two wing-shaped projections 7 and 8 on either side of the middle part 6. The wedge-shaped cross-section greatly simplifies the connection of the connector to a containment part of a container such as a flexible tube bag, as is known in the flexible bag world. To achieve a solder, a membrane structure 19 can therefore be provided in the lower part 16 of the connector 1.

The middle part 6 of the angular sectional cross section shows a fifth hole 11 extending from the upper end 17 to the lower end 16. The hole 11 can be used to pre-fill the containment part to be attached to the connector during assembly. manufacturing process with a substance.

The mounting means 2 and 4 project from the fins 7 and 8 by projections 28 and 29 in a direction perpendicular to the axes of the mounting means 2 and 4 and also to the axes of the holes 3, 5 and 11, which are all parallel . In the representation shown in figure 1, the projections 28 and 29 are tangent to one side of the fins 7 and 8.

In addition, the first termination 13 of the handle 12 is attached to the first mounting element 2 and the second end 14 of the handle 12 is attached to the second mounting element 4. To facilitate the use of the handle 12 the terminations 13 and 14 may comprise connections of flexible film.

Connector 1 also has a protrusion 15 that joins the second mounting element 4 with the middle part 6 of connector 1. This protrusion 15, as will be highlighted below, serves as a counterpart for a mounting detector to confirm the correct mounting of the connector in mating connectors.

In figure 2 a sectional view of the connector 1 is shown where the middle part 6 and the fins 7 and 8 are sectioned in half, and the view is from behind as seen in figure 1. The connector 1 extends from the lower termination 16 to upper termination 17. In the middle part, the through hole 11 is observed, which allows an easy pre-filling of the containment part that joins the lower termination 16 of the connector.

In the first wing 7 there is also a third through hole 9 and in the second wing 8 a fourth through hole 10. Although the third and fourth holes 9 and 10 have a variable section along their lengths from the lower termination 16 to the upper 17 of the container 1, this fact does not influence that the fluid communication is not established along its lengths. The third orifice 9 extends to a first distribution chamber 20 and the fourth orifice 10 to a second distribution chamber.

21.

As can be seen in Figure 1, the distribution chambers 20 and 21 communicate the fluid with the first and second holes 3 and 5 through the slots 22 and 23, respectively. By mounting the connector 1 attached to the mounting means described below, the fluid communication is thus established from the first hole 3 to the third hole 9 constituting a first fluid line, and from the second hole 5 to the fourth hole 10 constituting a second line fluid.

Figure 3 shows a further sectional view along the line AA as indicated in Figure 2. In this view the projections 28 and 29 of the mounting means 2 and 4 and also the first and second are shown more clearly. second holes 3 and 5 in a direction perpendicular to the vertical extension of fins 7 and 8 and the middle part 6 of connector 1.

According to the invention in the prototype of a container, the connector 1 shown in Figures 1 to 3 represents the connector part, the lower termination 16, to be joined to a container containing part. For this purpose the upper termination 17 is sealed along the circumference 26 - which also surrounds, thus sealing the fifth hole 11 - by a flexible sheet 18 by means of welding or similar joining techniques. Note that due to the design of the connector the flow paths for the first and second fluid lines are not blocked with this seal. Flexible sheet 18 is indicated in Figure 2.

The container body is shown in the figure

Four. The containment portion 31 of the container 30 is made up of a sealed pipe at the lower termination 32 and hermetically joined by welding or similar techniques at the upper termination 33 to the lower termination 16 of the connector 1. In the representation shown in FIG. 4 the container 30 is further pre-filled with a pulverized concentrate 34 of a substance that will be dissolved in an end use. The substance can be delivered under any condition, solid or fluid, as useful for the particular purpose.

To maintain sterility before use the lower ends 24 and 25 of ports 3 and 5 can be sealed in an appropriate way so that the interior of the container 30 is completely sealed to the outside. As an example a flap type gasket 27 is shown in figure 8 that seals both holes 3 and 5. The seal 27 can be removed by the user before use by peeling off the gasket as shown in figure 8.

Alternatively, tubes not shown and / or filters may be provided in container 30 being located in the first and / or second fluid lines in order to filter the fluid entering and / or leaving the bag and / or expanding the lines. lines to a particular site within containment portion 31. If it is desired to remove a saturated solution of a substance so that it dissolves, the fact will prove the usefulness of cleaning with water and the consequent dissolution of the fluid such as water near the upper termination 33 of the containment part 31 and the removal of the saturated solution near the bottom 32 of the containment part 31.

Also shown in figure 4 is a part 50 of a representation of a fluid preparation device according to the invention that has brought together the first and second mounting elements 53 and 54 to mount the connector 1 and thus the container 30. This first and second coupling is formed by the first and second insertion chambers 53 and 54 which have a complementary cross section such that the first and second cylindrical couplings 2 and 4 can be mounted by inserting themselves into these chambers. Any cross section can be used, but a circular cross section as shown in this representation is advantageous in favor of better disinfection and rinsing.

ES 2 256 348 T3

The first insertion chamber 53 communicates fluid with a third fluid line 51, the cleaning fluid line, which is connected to a source of cleaning fluid (not shown) for delivery of the cleaning fluid. This cleaning fluid is required during use of the container 30 in order to dispose of the fluid preparation from the prefilled material and the cleaning fluid - this will in most cases be just water. Consequently the second insertion chamber 54 communicates the fluid with a fourth fluid line 52, the preparation line, which allows the distribution of the preparation where it is required. This can still be within the fluid preparation device or via its corresponding release valve to be supplied elsewhere.

The part 50 of the fluid preparation device also comprises a sensing element 58 which in this embodiment is a mechanical microswitch. To assemble the container 30 and thus the connector 1, the projection 15 presses the switch 58 which by means of an electronic evaluation circuit of the fluid preparation device not shown allows the device to confirm the correct assembly of the connector

1. It is possible that this evaluation circuit will cause an actuator to block the flow of some cleaning fluid in the first insertion chamber 53 until such confirmation has occurred.

The part 50 of the fluid preparation device further contains a cover 59. The cover 59 rotates around a seal 65 from a first, open position shown in Figure 4, to a third, closed and preferably fixed position which will be described below. Between the first and third positions, the lid can be stopped, and better fixed, in a second position with the container 30 mounted as will also be explained below. The lid 59 has a first and a second closure portion 60 and 61 that are suitable for closing the first and second insertion chambers 53 and 54, respectively, when the lid 59 is in the third position.

Figure 5 shows the same view as Figure 4 with the connector 1 and the container 30 thus mounted in the part 50 of the fluid preparation device. The first and second mounting elements 2 and 4 are inserted into the first and second insertion chambers 53 and 54. On the other hand, there are two proximity sensors 63 and 64 in the part 50 that detect the presence of the cover 59 both in the second as well as the third position. These proximity sensors can be non-mechanical like the Hall sensors that detect the proximity of certain parts of the cover 59. These sensors can also comprise alternating elements that are actuated by counterpart elements (not shown) of the cover that serve at the same time to fix the cover 59 in the second or third position.

Figure 6 shows a first sectional view of the arrangement shown in Figure 5 with the cover 59 in the second position, holding the connector 1 in its push-mounted position with the closing portions 60 and 61 of the connector 1. The sectional view it is taken along the fluid line 51 and the first insertion chamber 53 viewed from left to right in Figure 5. The prepared fluid line 52 and the second insertion chamber 54 are symmetrical in design.

Within the first insertion chamber 53 there is a first male connection element 55 where the cleaning fluid line 51 terminates within the first insertion chamber 53. The first male connection element 55 is attached to the housing of the part 50 with a compensation and sealing element 57 which can be made of any suitable material, eg. ex. Rubber. The compensation and sealing element 57 allows movements of the first male connection element 55 with respect to the housing in order to compensate the tolerances that may exist between the parts of the connector 1.

In the arrangement of Figure 6 the first hole 3 and hence the first fluid line of the connector 1 and the container 30 is now in fluid communication with the cleaning fluid line 51. The hole 3 is bounded by a first mouth sealing ring 66 on the lower circumference of the first mounting elements 2. The sealing mouth 66 can be easily created by injection molding. The mouth 66 ensures a connection of holes, surrounding its external circumference, to the first male connection element 55.

The first mounting element 2 inserted into the first insertion chamber 53 until the first passage element 69 of the first mounting element 2 touches the housing of the part 50 of the fluid preparation device.

A fifth fluid line 62 branches out from the first insertion chamber 53. When the connector 1 is assembled this fifth fluid line 62 will be sealed by the first sealing mouth 66, that is, there will be no fluid communication towards the first and third fluid lines connected, the latter being the cleaning fluid line 51.

For the connection of the second and fourth fluid lines there are corresponding elements, that is, a second male connector element, a second compensation and sealing element, a second sealing mouth, a second passage element and a sixth fluid line. that branches out.

The mission of the fifth and sixth fluid lines becomes apparent in the form of figure 7. This figure shows a second sectional view of part 50 of the fluid preparation device. This differs from Figure 6 in that the connector 1 is not mounted and the cover 59 is in the third closed position. The first insertion chamber 53 is now closed thanks to the first closing part 60 which is part of the lid 59. The closure is sealed by the sealing elements 67 on the outer circumference of the first closure part 60, which is realized by means of a ring gasket. On the inner face of the first closure part 60 there is a first opening 68 having a diameter larger than the outer diameter of the first male connector element 55.

In this configuration the fluid lines of part 50 of the fluid preparation device can be easily flushed with any fluid such as a disinfection fluid or with water. When the second closure part 61 seals the second insertion chamber 54 in a similar way, the rinsing fluid can be provided by the third fluid line, that is, the cleaning fluid line 51. It is then that the cleaning fluid enters the first insertion chamber 53 and leaves it via the fifth line 62. In this representation the fifth and sixth lines meet (not shown). The rinsing fluid therefrom enters the second insertion chamber 54 through the sixth fluid line and exits it through the fourth fluid line, that is, the prepared fluid line 52. Me4

ES 2 256 348 T3 This configuration enables easy and efficient rinsing and / or disinfection of all relevant parts of the fluid preparation device in the area of ​​the coupling connector. No part above the seal 67 is reached by the flushing fluid, but these parts will not be part of the fluid path if the connector 1 is also not connected.

Connector 1 or container 30, respectively, can be designed as non-reusable parts. Hence, they should not look for special solutions for disinfection. In this case a sensitive part such as the sealing mouth 66 is automatically exchanged from one use to another without requesting another supplementary part or expensive maintenance procedures.

Detector elements 63 and 64 perceive cover 59 in the second or third position. The electronic evaluation circuitry of the fluid preparation device monitors the signals provided by these sensing elements in order to confirm an expected position of the cap 59 during specific modes of the fluid preparation device such as disinfection or in-line fluid preparation.

Note that the wedge cross section of connector 1 is the preferred representation. Any other form of the connector that satisfies the concept of the invention as indicated in the claims would however allow a simple handling of the connector system during its use. As is evident in Figures 4 to 7, the shape of this part of the connector hardly has any influence on the same steps for connection.

The invention thus provides reliable and user-friendly components for a fluid preparation system consisting of a container with a special connector and a fluid preparation device. The container can be pre-filled with a substance, but the applications are also suitable when the container is initially empty and is filled or emptied during use. The container can be of any type, rigid or flexible. However, a flexible bag represents a preferred configuration.

The components of the inventive system are particularly useful in the medical field where handling is especially sensitive to sterile conditions. At the same time the invention provides solutions of no less interest. The invention has proven particularly useful in the field of dialysis where the fluid preparation device forms part of the dialysis device. The prepared fluid could symbolize only a part of the complete dialysis fluid such as bicarbonate, or the complete dialysis fluid. It can be applied to any type of dialysis such as hemodialysis or peritoneal dialysis.