Abstract:
The present invention relates to a connector for a replaceable container to be used in a medical machine, which is comprised by at least a body, the inner side of which is traversed by inlet and outlet tubes extending from within such container towards an outer side of the connector, wherein said tubes separately extend leading to two laterally spaced-apart apertures that are removably attachable to a mounting means and supplementary connection of said machine.

Description:
FIELD OF THE INVENTION 
       [0001]    Hemodialysis machines use one or several aqueous solution salt concentrates—such as, for example, a sodium bicarbonate solution—to purify blood in patients under dialysis treatment, thus working as a sort of artificial kidney. This concentrate can be derived by the machine from powdered or granular salt compounds that are provided in disposable, replaceable containers that can be of a bag type. In the standard process, water is provided by the machine to dissolve, e.g. the powdered sodium bicarbonate, the usable solution being concomitantly removed from the container through a separate tube. 
         [0002]    The present invention relates to a connector that is disposed in the container and serves to attach the container to the dialysis machine, which connector is formed by the water inlet and solution outlet. 
       BACKGROUND OF THE INVENTION 
       [0003]    Patent EP No 1,344,550 describes a connector that serves the same purpose, made of one piece with three tubes. The main tube is a central bore which completely traverses the member between its outer and inner sides (the latter being thus defined because it is within a tubular container once the connector is placed in the corresponding opening in such container), which is used to fill the container with soluble solid powdered or granular salts, whereby it has a greater diameter. The other two tubes are designed for water inflow and solution outflow, respectively, and they each have a length that is parallel to the central tube from the inner side of the connector to the vicinity of the outer side, wherefrom they outwardly diverge to extend in a parallel direction along a respective side wing or along the edge of the outer side leading to a cylindrical portion configured to be plugged into a dialysis machine. FIGS. 4 and 5 of such European Patent show the general features of a mounting console of the aforesaid dialysis machine model, wherein the side tubes are seen following paths forming more than one bend such that, for mold-designing purposes, if the member were made of plastic, the open side tubes could be molded on the outer side. 
         [0004]    The pre-filling operation is typically carried out during the container manufacturing process itself and it can be followed by a sealing operation wherein a compliant sheet is welded onto the outer side of the connector to cover the mouth of the central tube, as can be seen in FIG. 2 of the aforementioned European Patent No. 1,344,550, to avoid both the loss of its contents and its contamination within the container. These procedures are performed in a sterile area. The same sheet also covers the side tubes that are molded with openings therein, as shown in FIG. 1 of such patent. 
         [0005]    Patent AR No 37,133 refers to a connecting cap for a bi-compartment bag used with another hemodialysis machine. FIGS. 3; 4, and 5 of such patent AR No 37,133 show a connector having two inlet and outlet tubes, which is made of an assembly of two sealed and nested members. One member is of annular shape and it is incorporated into the replaceable bag in such a manner that on its inner side, each tube is in fluid communication with a separate compartment. The second, central member is not placed within the annular member until just after the bag has been pre-filled with the powdery product through the larger diameter central tube. The central member is formed with a disk sealing the central tube once it has been snapped into the annular member, thus forming a connector to attach the bag to the dialysis machine when the latter opens such disk as a valve to let the water in and dissolve the product, with the machine removing the resulting solution via the side tube. 
         [0006]    Finally, FIGS. 2 and 3 of Published Patent Application AR No 35,471 show a two-piece molded connector having ribs to allow for its assembly. 
       SUMMARY OF THE INVENTION 
       [0007]    An object of the present invention is to develop another connector to be used on this type of replaceable container as described in AR No 35,471. 
         [0008]    Another object of this invention is to eliminate the opening-sealing procedure on the outer side of the connector by means of a welded sheet or film, as is done in the aforementioned European Patent. A further object is a connector structure that is provided with a novel sealing system that is effective for one- or two-compartment disposable containers. 
         [0009]    The further problem solved by the invention is that of achieving a sealing of the open channels or grooves formed by the tubes around the outer side of the connector wings, in a safer and more cost-efficient manner. 
         [0010]    The problems are solved by a connector according to claim  1 , a replaceable, disposable container according to claim  11 , a method of making a connector according to claim  14  and a method of making a replaceable device according to claim  16 . Variants of the invention are the subject of the dependent claims. 
         [0011]    These and other benefits, objects and solutions, which will become apparent from the following description, are in one embodiment achieved by shaping a connector having a cap attached to the connector body itself by means of compliant, hinged, or frangible linkages. In a further operation, the cap is folded around the outer side and sealingly closed to block the tube openings on the side wings thereof. 
         [0012]    In a preferred embodiment, the connector comprises an member, preferably an annular member, lodged in the bag opening and that is configured as disclosed in Patent Application AR 35,471, through which the solid product pre-filling operation is carried out, and a central member that makes up a nozzle with the essential features of the connector as listed in the previous paragraphs. 
         [0013]    The disclosures of the patent applications AR 35,471 and EP 1 344 550 A1 are incorporated in the present application by reference. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]    For a ready understanding of the present invention and the manner it can be put in practice, a detailed description of a preferred embodiment of the invention is shown below, with reference to the exemplary drawings appended thereto, that are intended to be illustrative, and not limiting of the invention, and the components of which will be selected by the skilled person from various equivalents without departing from the principles of the invention. In the appended drawings it can be seen that: 
           [0015]      FIG. 1  is an exploded perspective view of a single-compartment disposable dialysis bag provided with a connector according to a preferred embodiment of the present invention. 
           [0016]      FIG. 2  is top perspective view of the connector shown in  FIG. 1 , with the collapsible cap initially open to expose the respective solvent and solution inlet and outlet ports. 
           [0017]      FIG. 3  is a perspective view, analogous to  FIG. 2 , but wherein the connector is shown with the collapsible cap closed, such that the inlet and outlet ports in all the extensions contiguous to the outer side of the piece are sealed. 
           [0018]      FIG. 4  is a bottom front perspective view of the connector shown in  FIG. 1  as molded. 
           [0019]      FIG. 5  is a bottom rear perspective view of the connector shown in  FIG. 4 . 
           [0020]      FIG. 6  is a bottom perspective view of the connector shown in  FIG. 2  with its connection ports now sealed. 
           [0021]      FIG. 7  is a rear perspective view of the connector shown in  FIG. 6 . 
           [0022]      FIG. 8  is a view of the member that is sealingly affixed to the connector as shown in  FIGS. 6 and 7 . 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0023]    With reference to  FIG. 1 , it is first shown an elongated single-compartment bag  11  made of two wall sheets having an opening  13  in one of the wall sheets, and a connector  15  that is shown unattached for illustration purposes. In order to place the connector member  15  in the bag, an ancillary member  17  which in this embodiment is of annular shape is positioned at the rim of the opening  13 , which annular member is capable of centrally receiving the connector body  15  within its throat or opening  13 , thus forming a sealing fit. 
         [0024]    As shown in  FIG. 2 , the member  15  comprises a central body  19  having annular ribs  21 , which allow for a firm hold within the opening  13  of the annular member  17 , and two wing-like lateral extensions  23  within which tubes or conduits  25  extend to respectively inject water and remove the solution therethrough. These conduits  25  extend from corresponding apertures  27  in the wing ends  23 , that are configured to allow the attachment and connection to a dialysis machine (not shown), having some lengths that form channels  29  that are open on one end on the outer or rear side  31  of the member, then leading into the inner side  33  of the connector, wherein the solution outlet tube has an extremity for the attachment of a suction tube  35 , the terminal edge of which ends in a filter  37  such that, in use, the latter is lodged at the bottom of the bag  11 , at the opposite end of the opening  13 . Similarly the inlet tube to inject the water can have a filter element directly at its end in the central body  19 . The filter element can be made by various manufacturing techniques. In one embodiment the orifice of the inlet tube is covered by a non-woven welded sheet which is welded or glued to the central body. The inlet orifice may also have a small extremity pointing into the container and having an enlarged cross-section compared with the outlet tube. 
         [0025]    For brevity purposes, any further details on the conventional aspects of the disclosure so far are omitted, since they are known from the aforementioned patents. The permanent bond between the annular member and the sheet material the bag  11  is made of, as well as the snap fitting thereto of the central member or the actual nozzle  15 , may have the same characteristics as shown in the above Publication AR No 35,471. 
         [0026]    In accordance with one aspect of the invention, the connector member  15  is molded with a cap  39  attached thereto by two linking flexible strips  41 . Such cap  39  has the same transversally elongated configuration as the aforementioned rear side  31  of the wings  23  in the connector  15 , together with internal protuberances  43  replicating the open portions  29  of the tubes. Thus, it is easy to understand that, when the cap  39  is folded over the outer side  31  of the connector  15 , thus folding the strips  41  which attach it to the ends of wings  23 , protuberances  43  snap fit within the open channels  29  far enough to seal them, the sealing being guaranteed by ultrasound or laser welding. 
         [0027]    In the illustrated example, wings  23  have an 87.3 mm span to accommodate a 78.0 mm length between the central points of the mounting apertures and connection  27 . The open channels  29  have a 4.1 mm width, whereas the cap  39  has a 1.0 mm thickness, just like protuberances  43  on the inner side of the cap  39 . Strips  41  attaching the cap onto the body  15  of the connector are 3.0 mm long, 2.0 mm wide and 0.8 mm thick. 
         [0028]      FIG. 4  shows the apertures  27  that the channels  29  of the connector  15  lead into, and  FIG. 5  shows a reinforcing structure  45  that serves to stiffen the said member. Once the central piece  15  of the connector with the cap  39  already welded onto it, as disclosed above, and the bag  11  with the annular member  17  have been made, the powdered product is filled into the bag  11 . The member  15  of the actual connector is then placed on the annular member  17 , by first introducing the suction tube  35 , which serves as an extension of the solution outlet, such that the filter  37  reaches the bottom of the bag  11 . Both apertures  27  are sealed as shown in  FIGS. 6 and 7  by means of a polyester-coated sheet  47  as shown in  FIG. 8 , which is bonded by a peel-off hot melt, and then the filled and sealed device containing the substance to be dissolved is ready to be shipped to a point of use, i.e. a hospital, clinic or dialysis center. It is seen that the annular member  17  serves two purposes: as an inlet port for the solid matter to be dissolved and as a sealing mounting and retention member on the central member of connector  15  having the characteristics of a finished plug. 
         [0029]    When it is time for use, the device is promptly attached to a dialysis machine, after the peel-off sheet  47  has been lifted from apertures  27 , and plugged into the mounting console of the machine, after which the latter will pump pure or distilled water via one of the tubes  25  in order to dissolve the solid matter. After being contacted by water, such solid matter forms a solution with the solid contents that is capable of passing through sieve  37  such that it can be sucked by tube  35  and carried through the outlet tube  21  into the machine for the purifying treatment of the blood taken from the patient to be detoxified and returned by extracorporeal circulation in the case of hemodialysis. When the product in the device bag has been depleted, the connecting apertures  27  are unplugged and the device is disposed of or replaced to perform another treatment with a new device. 
         [0030]    It will be apparent that various modifications and additions could be introduced into the embodiment disclosed herein, as long as they are consistent with the spirit and scope of the present invention. For instance, while the invention has been described regarding a replaceable device suitable for a hemodialysis machine, it should be apparent that the solution provided could eventually be used in other medical application with analogous problems to solve such as a peritoneal dialysis machine. It should also be apparent that while the described embodiment uses a bag, the concept of the invention is applicable to containers in general, independent of the flexibility of the walls of the container.