Abstract:
A coupling device that reduces the risk of cross-contamination of dialyzers during reprocessing by providing a reusable, easily disinfected connector for coupling a dialyzer to, e.g., the blood line of a dialyzer reprocessing system. The coupling device is in the form of a one-piece adapter for being screwed to the luer connector of a dialyzer and then axially attached to a blood line of a dialyzer reprocessing device via a quick connect/disconnect coupling. The adapter is reusable and easily disinfected by soaking it in liquid disinfectant.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates to a coupling assembly and, more particularly, to a coupling device for interconnecting a dialyzer reprocessing system to a dialyzer blood port. 
     2. Description of the Related Art 
     There is significant concern about possible cross-contamination of dialyzers that are being reprocessed if the blood port connector on the reprocessing machine is not adequately disinfected between uses. Many conventional dialyzer reprocessing systems use a luer/tubing connector to connect the blood line thereof to the dialyzer blood port. This connector is generally not removed from the reprocessor tubing and, therefore, disinfection is typically limited to wiping the connector with disinfectant. In addition, the tubing must be twisted in order to thread the connector onto the luer connection of the dialyzer blood port. 
     Some reprocessing systems provide a quick connect/disconnect coupling on the blood line thereof. Conventional quick connect/disconnect couplings are adapted to interconnect tube segments and thus use conventional tubing connectors. See in that regard, U.S. Pat. No. 5,052,725, the disclosure of which is incorporated herein by this reference. Therefore, a conventional quick disconnect can only be used to interconnect a quick connect/disconnect equipped reprocessor to the luer fitting on the dialyzer if additional tubing is used to connect the quick disconnect to a luer/tubing connector that is in turn connected to the luer connector of the dialyzer. This additional tubing means that there are additional parts that must be disinfected and the tubing must still be twisted to thread the luer connector onto the dialyzer port. In addition, the cost of multiple sets of the removable portion, i.e. the tubing with connectors on both ends, makes disinfecting by removal and soaking impractical. Therefore, providing a quick disconnect coupling on the blood line does not solve the problem of improving disinfection and simplifying attachment to the luer connector of the dialyzer. 
     SUMMARY OF THE INVENTION 
     It is an object of the present invention to provide a coupling device that reduces the risk of cross-contamination of dialyzers during reprocessing by providing a reusable, easily disinfected connector for coupling a dialyzer to, e.g., the blood line of a dialyzer reprocessing system. 
     It is a further object of the present invention to provide a coupling device that allows a dialyzer to be coupled to a dialyzer reprocessing system without rotating or twisting associated tubing. 
     The foregoing objects are realized in accordance with the invention by providing a coupling device that is a simple, one-piece adapter for being screwed to the luer connector of the dialyzer at a luer connector end thereof and then axially attached to a blood line of a dialyzer reprocessing device via a quick connect/disconnect coupling end thereof. The adapter is reusable and easily disinfected by simply soaking it in liquid disinfectant. Since there is no tubing incorporated in the adapter, costs are minimized and handling is facilitated. Moreover, the thicker side wall realized by the elimination of a tubing nipple extends the connector life and makes it more reliable. In accordance with a presently preferred embodiment, the adapter also includes grip wings or a grippable outer surface to facilitate threading of the luer connector end thereof to the dialyzer blood port. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     These, as well as other objects and advantages of this invention, will be more completely understood and appreciated by careful study of the following more detailed description of presently preferred exemplary embodiments of the invention taken in conjunction with the accompanying drawings, in which: 
     FIG. 1 is a schematic illustration of a coupling device provided in accordance with the invention disposed for connecting a dialyzer reprocessing system and a dialyzer; 
     FIG. 2 is a perspective view of a coupling device provided in accordance with a preferred embodiment of the invention, taken from the luer connector end thereof; 
     FIG. 3 is an end view of the coupling device, taken from the luer connector end thereof; 
     FIG. 4 is a perspective view of a coupling device provided in accordance with a preferred embodiment of the invention, taken from the quick disconnect end thereof; 
     FIG. 5 is an end view of the coupling device, taken from the quick disconnect end thereof; 
     FIG. 6 is an elevational view of the coupling device provided in accordance with the invention; 
     FIG. 7 is a view taken from above in FIG. 6; and 
     FIG. 8 is a view taken along lines  8 — 8  of FIG.  7 . 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The coupling device  10  provided in accordance with the present invention is formed as a single, molded piece, that is constructed and arranged to act as an adapter between the coupling  12  provided at a blood port of a dialyzer  14  and a coupling structure  16  provided on a blood line  18  of a dialyzer reprocessing system  20 . 
     The dialyzer  14  with which the coupling device  10  of the invention is adapted to be used has blood ports (only one of which is schematically shown in FIG. 1) with luer-type connectors  12 , for example, a luer tip  22  surrounded by a shroud  24  having internal threads. To securely engage the luer connector of the dialyser blood port, one end of the adapter  10  is formed as an externally threaded luer-type connector structure  26  so that the connector can be screwed to the dialyzer blood port connector  12 . The luer connector structure  26  may be a luer-type thread  28  that extends part circumferentially, in a spiral of about 180° in the illustrated embodiment, or may be more truncated luer tabs or ears. 
     To facilitate gripping and rotating of the adapter during connection to the dialyzer blood port, the main body  30  of the coupling device preferably has a friction enhanced, grippable surface defined thereon. While the grippable surface may be a knurled surface or a surface having a series of, for example, longitudinally extending ribs, in accordance with the present preferred embodiment, at least two grip wings  32  are formed to extend from diametrically opposite sides of the adapter main body  30 . In the illustrated embodiment, the grip wings each extend radially outwardly from and along a portion of the length (longitudinally) of the main body to define digit engaging surfaces  34  which facilitate gripping and rotation of the adapter, particularly during the luer attachment process. More specifically, each of the grip wings  32  is defined by a longitudinally extending and radially projecting spine  36  and a plurality of radial and part circumferential flanges or ribs  38 . The part circumferential ribs have gaps  40  therebetween so as to define discontinuous digit engaging surfaces  34  which facilitate gripping and are advantageous in the molding process. In the illustrated embodiment, furthermore, the ribs  38  define finger engaging surfaces  34  that are inclined to the plane of the grip wing spine  36 . It is to be understood that as an alternative to the grip wing structure shown, generally planar grip tabs may be provided and thus the illustrated embodiment is merely exemplary of a grip wing configuration that may be provided, showing the presently preferred embodiment of the invention in this regard. As shown for example in FIG. 7, the interior bore  42  of the adapter is tapered as at  44  from a maximum internal diameter adjacent the inlet to the screw threaded, luer end  26  and tapers to a minimum dimension at substantially a midpoint  46  of the adapter structure. 
     The second end of the adapter provided in accordance with the present invention is defined as a quick disconnect coupling structure  48  so that the adapter, once threaded to the dialyzer blood port, may be connected to a complimentary female quick disconnect coupling  16  provided at a free end of the blood line  18  extending from the dialyzer reprocessing system  20 . The configuration of the quick connect/disconnect end  48  generally corresponds to conventional quick connect couplings of the type shown in U.S. Pat. No. 5,052,725. Thus, the quick connect/disconnect end is adapted to be coupled to a female connector of the type illustrated in the 725 patent provided at the free end of the reprocessing tubing. More specifically, the quick connect/disconnect male coupling defines a first sealing recess  50  adjacent the free end  52  thereof for receiving an O-ring (not shown) about the exterior surface thereof, thereby to provide a fluid tight seal between the exterior surface of the male coupling member  48  and the interior surface of the conventional female quick disconnect coupling member  16  when in the connected state. The quick disconnect connector end includes a further, locking recess  54  for receiving a conventional component, such as a spring urged clip member  56 , mounted to the female coupling  16  so that when the male coupling is inserted into the female coupling, the clip is initially engaged by and displaced by the rounded tip  52  of the male connector and then upon alignment with the second groove or locking recess  54 , the clip  56  is resiliently displaced into the groove to lock the male connector within the female connector, in a conventional manner. As shown, for example, in FIG. 7, the bore in the quick connect coupling end of the adapter provided in accordance with the invention is tapered as at  58 . The bore is tapered from a maximum diameter adjacent the free end  52  of the quick connect coupling  48  end to a minimum diameter substantially at the mid point  46  of the adapter. As can be seen, for example, in FIGS. 2 and 3, in particular, a stop flange  60  is also defined peripherally of the adapter to limit insertion of the quick connect coupling structure  48  into the female coupling  16 , to ensure proper registry of the clip  56  of the female coupling  16  with the locking groove of the quick connector  48 . 
     In an exemplary embodiment, the adapter provided in accordance with the invention is molded from a semi-rigid PVC material. 
     As described above, the coupling device  10  of the invention is adapted to couple a dialyzer  14  having a blood port that comprises a luer type coupling, shown generally at  12 , to a dialyzer reprocessor  20  having a blood line tube  18  terminating at its free end in a female quick connect/disconnect coupling structure  16  of the type disclosed, for example, in U.S. Pat. No. 5,052,725. An exemplary dialyzer reprocessor is the Renatron®, which is an embodiment of the reprocessor disclosed in U.S. Pat. No. 4,517,081, the disclosure of which is incorporated herein by this reference. To couple the dialyzer  14  to the dialyzer reprocessor  20 , the coupling device  10  is first coupled to the dialyzer  14  by rotating the coupling device  10  to engage the luer type connector  26  provided on the coupling device/adapter  10  to the luer type connector structure  12  provided on the dialyzer  14 . In the disclosed embodiment, the luer type connector provided on the adapter defines a tapered interior bore  44  for receiving the tapered luer tip  22  of the luer connector  12  on the dialyzer and a screw thread  28 , or luer tabs or ears, defined on the exterior surface of adapter  10  for engaging screw threads (not shown) defined on the interior of the shroud  24  encircling the luer tip  22  of the blood port connector  12 . Once the coupling device  10  has been coupled to the dialyzer  14 , the male quick connect coupling end  48  of the adapter  10  can be axially inserted into the complimentary female quick connect/disconnect connector  16  provided on the free end of the blood line tube  18 . In a known manner, a radial locking structure, such as a spring biased clip  56 , engages the locking groove  54  of the adapter  10  to axially lock the adapter relative to the blood line tube. 
     As is apparent from the foregoing, the adapter provided in accordance with the invention simplifies the connection process and allows the operator to perform a more significant disinfection process, e.g., by soaking the coupling device. Indeed, the connector provided in accordance with the invention allows the user to remove it after each use and soak it in a disinfecting agent while using another already disinfected connector for the next cycle. A better, easier disinfectant capability is thus provided in accordance with the invention that provides for a longer dwell time in the disinfecting agent. In addition, the one piece molded connector provided in accordance with the invention defines a thicker side wall which will extend the connector life and make it more reliable. Moreover, because the adapter has no tubing associated with it and can be first threaded to the dialyzer, tube twisting is eliminated, thus simplifying the connection process and minimizing the risk of damage to or disconnection of the reprocessor blood line during the dialyzer connection process. It is therefore anticipated that the adapter of the invention will have a long life, be more reliable, and be universally easier to connect than conventional connectors, in particular for dialyzer reprocessing. 
     While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiment, it is to be understood that the invention is not to be limited to the disclosed embodiment, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims. Thus, while the invention has been described with reference in particular to dialyzer reprocessing, it is to be understood that the coupling of the invention is not to be limited to that implementation except as so specified in the claims presented hereinbelow.