Abstract:
The present disclosure describes an adapter for use with two connectors in, for example, a pleural, peritoneal or other bodily fluid drainage system. The adapter allows the use of the disposal bag from one manufacturer to be used with the catheter of another. This simplifies the storage requirements of distributors and hospitals and reduces the everyday challenges faced by those patients requiring fluid drainage.

Description:
[0001]    This application claims the benefit of priority from U.S. Provisional Application No. 61/651,075 filed on May 24, 2012 and from U.S. Provisional Application No. 61/655,599 filed on Jun. 5, 2012, the contents of which are incorporated herein by reference. 
     
    
     BACKGROUND 
       [0002]    The present disclosure relates to an apparatus and method for draining fluids from a body. 
         [0003]    Fluid production in a part of the human body like the chest, abdomen or other area may be caused by disease, injury or as a result of surgery. The medical professional, a care giver or the patient if he is capable, may need to drain such effusion fluids that accumulate at the site of an injury to relieve pressure felt by the patient and to remove the excess fluid that may harbor infection. Drainage from the thoracic cavity or pleural cavity surrounding the lungs, known as pleural drainage, is commonly performed by the patient at home or at work. Drainage may occur at any time interval as determined by the patient&#39;s level of discomfort and may take from a few minutes to an hour. 
         [0004]    In this system as illustrated in  FIG. 1 , a catheter  10  with a short length of tubing  12  is typically surgically installed in the pleural cavity with the other (distal) end of the tubing terminating outside the body. The catheter is usually installed under local anesthesia and is not changed or removed unless it becomes infected or is no longer needed. When drainage of the fluid becomes necessary, a canister  14  is attached via tubing  16  to the distal end of the tubing that was surgically installed in the patient&#39;s chest via a set of connections  18 . The fluid usually drains via gravity into the canister, though some products use an evacuated canister. Some systems use a disposable plastic bag or other container in place of the drainage canister. 
         [0005]    Various manufacturers compete in the marketplace to produce in-dwelling catheters, tubing connectors and canisters or bags for pleural drainage. These products are incompatible with the products of the other manufacturers. Bard Medical produces the BARD® Channel Drain. Carefusion sells the PleurX® catheter system that uses vacuum (an evacuated canister) to remove fluids. 
         [0006]    The incompatibility of the products produced by manufacturers poses a problem for users who must ensure that they have the proper type of bag on hand. This also creates a problem for distributors and hospitals since they must stock multiple types of bags so that they have the proper bag available for their customers. 
         [0007]    What is needed is a way of connecting the bags of one manufacturer to the catheter tubing of other manufacturers in order to simplify the storage requirements of distributors and hospitals, and to reduce the everyday challenges faced by those patients requiring pleural drainage. 
       SUMMARY 
       [0008]    The present disclosure describes an adapter connector for use with pleural, peritoneal or other bodily fluid drainage disposal bags. The adapter allows the bag of one manufacturer to be connected to and used with the in-dwelling catheters of other manufacturers. This simplifies the storage requirements of distributors and hospitals and reduces the everyday challenges faced by those patients requiring fluid drainage. 
         [0009]    Other objects, advantages and applications of the present disclosure will be made clear by the following detailed description of a preferred embodiment of the disclosure and the accompanying drawings wherein reference numerals refer to like or equivalent structures. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]      FIG. 1  is a drawing of a patient having a catheter for drainage placed in the chest, tubing leading from the chest to a drainage bag, and connectors between the two for disconnecting the bag from the catheter tubing. 
           [0011]      FIG. 2  is a drawing of the catheter end (left side piece) and bag end (right side piece) connectors from Bard Medical just before they are connected together. The Bard medical connector has a set of tines on the bag end connector that is held by a notch or ledge on the catheter end connector. 
           [0012]      FIG. 3  is a drawing of the catheter end and bag end connectors from Bard Medical when they are connected together. The tines of the bag end connector have spread slightly and slipped over the ledge on the catheter end connector to hold the two connectors firmly together. 
           [0013]      FIGS. 4A-D  are drawings of the catheter end and bag end connectors from Bard Medical when they are connected together, when viewed from different angles and cross-sectional views.  FIG. 4A  is a cross sectional view along the widest part of the catheter end connector along the axis indicated in  FIG. 4C .  FIG. 4B  is a cross sectional view at 90 degrees to  FIG. 4A , along the axis indicated in  FIG. 4D .  FIG. 4C  is an exterior view of the orientation of the connectors in  FIG. 4B  and  FIG. 4D  is an exterior view of the orientation of the connectors in  FIG. 4A . 
           [0014]      FIG. 5  is a drawing of the catheter end (left side piece) and bag end (right side piece) connectors from Carefusion just before they are connected together. 
           [0015]      FIG. 6  is a drawing of the catheter end and bag end connectors from Carefusion when they are connected together 
           [0016]      FIG. 7  is a drawing of only the bag end connector from Carefusion. 
           [0017]      FIGS. 8A-D  are drawings of a connector on the catheter end of a fluid drainage system from Kimberly-Clark.  FIG. 8A  is a perspective view of the catheter end connector showing the distal and proximal ends.  FIG. 8B  is a cross sectional view along the widest part of the catheter end connector along the axis indicated in  FIG. 8D .  FIG. 8C  is a cross sectional view at 90 degrees to  FIG. 8B  along the axis indicated in  FIG. 8E .  FIG. 8D  is an exterior view of the orientation of the connectors in  FIG. 8C  and  FIG. 8E  is an exterior view of the orientation of the connectors in  FIG. 8B . 
           [0018]      FIGS. 9A-C  are drawings of a connector on the bag end of a fluid drainage system from Kimberly-Clark.  FIG. 9A  is a perspective view of the connector showing the distal end and proximal end. The central stem and tines are also clearly visible.  FIG. 9B  is a cross sectional view of the connector and  FIG. 9C  is a top view of the connector looking down on the tine at one side. 
           [0019]      FIGS. 10A-E  are drawings of the catheter end (left side piece) and bag end (right side piece) connectors from Kimberly-Clark when they are connected together.  FIG. 10A  is a perspective view of the two connectors when they are attached to each other.  FIG. 10B  is a cross sectional view along the narrowest part of the connectors along the axis indicated in  FIG. 10  D.  FIG. 10C  is a cross sectional view at 90 degrees to  FIG. 10B  along the axis indicated in  FIG. 10  E.  FIG. 10D  is an exterior view of the orientation of the connectors in  FIG. 10C  and  FIG. 10E  is an exterior view of the orientation of the connectors in  FIG. 10B . 
           [0020]      FIGS. 11A-E  are drawings of an adapter that can be used between the connectors on the catheter end and the bag end of a fluid drainage system.  FIG. 11A  is a perspective view of the adapter showing the distal end and proximal end with its elongated portion.  FIG. 11B  is a cross sectional view of the adapter along the axis indicated in  FIG. 11D .  FIG. 11C  is a cross sectional view at 90 degrees to  FIG. 11B  along the axis indicate in  FIG. 11E .  FIG. 11D  is an exterior view of the orientation of the adapter in  FIG. 11C  and  FIG. 11E  is an exterior view of the orientation of the adapter in  FIG. 11B . 
           [0021]      FIGS. 12A-D  are drawings showing the interaction of the adapter (left side piece) and the connector on the bag end (right side piece) of a fluid drainage system from Kimberly-Clark.  FIG. 12A  is a perspective view of the adapter and bag end connector when they are attached to each other.  FIG. 12B  is a cross sectional view of the adapter and connector along the narrowest part of the connector along the axis indicated in  FIG. 12D .  FIG. 12C  is a cross sectional view at 90 degrees to  FIG. 12B  along the axis indicated in  FIG. 12E .  FIG. 12D  is an exterior view of the orientation of the adapter and connector in  FIG. 12C  and  FIG. 12E  is an exterior view of the orientation of the adapter and connector in  FIG. 12B . 
           [0022]      FIG. 13  is a drawing showing the interaction of the adapter (center piece) and the connector on the catheter end (left side piece) of a fluid drainage system from Carefusion with a connector on the bag end (right side piece) of a fluid drainage system from Kimberly-Clark. 
       
    
    
     DETAILED DESCRIPTION 
       [0023]    Reference will now be made to the drawings in which the various elements of the present disclosure will be given numeral designations and in which the disclosure will be discussed so as to enable one skilled in the art to make and use the disclosure. It is to be understood that the following description is only exemplary of the principles of the present disclosure, and should not be viewed as narrowing the pending claims. Those skilled in the art will appreciate that aspects of the various embodiments discussed may be interchanged and modified without departing from the scope and spirit of the disclosure. 
         [0024]    A number of different and incompatible styles of connectors are used for pleural, peritoneal or other fluid drainage. These different connectors have common features however, that allow them to be used in a similar manner. The connector on the catheter end, the end that remains connected to the patient, must have a valve, usually a one-way or “check” valve, to stop liquid from draining when the connector is not connected to a drainage bag connector. The connector on the bag end must have a means for opening the one-way valve so that liquid can flow between the two and into the bag. The connectors must be able to connect to tubing and of course must have a channel or cannula through their bodies for liquid to flow. After these criteria have been met the connectors may be very different. 
         [0025]    The connectors that manufacturers have independently developed are of different shapes and sizes. These differences make it impossible or at least quite difficult to use, for example, the bag of one manufacturer with the catheter of another. 
         [0026]    Examples of different catheter end and bag end connectors and adapters are shown in the Figures and described below. 
         [0027]      FIG. 2  is a drawing of a set of connectors from Bard Medical showing the bag end connector  200  and catheter end connector  100  immediately before they are connected together. The Bard medical connector has a set of tines  212  on the bag end connector  200  that is held by a notch or ledge  112  on the catheter end connector  100 . 
         [0028]      FIG. 3  is a drawing similar in nature to  FIG. 2  but after the connectors  100 ,  200  have been connected together. The tines  212  of the bag end connector  200  have spread slightly and slipped over the ledge  112  on the catheter end connector  100  to hold the two connectors firmly together. 
         [0029]      FIGS. 4A-D  are drawings of the connected Bard Medical connectors from various views.  FIG. 4A  is a cross sectional view along the widest part of the catheter end connector  100  along the axis indicated in  FIG. 4C .  FIG. 4B  is a cross sectional view at 90 degrees to  FIG. 4A , along the axis indicated in  FIG. 4D .  FIG. 4C  is an exterior view of the orientation of the connectors in  FIG. 4B  and  FIG. 4D  is an exterior view of the orientation of the connectors in  FIG. 4A . 
         [0030]      FIG. 5  is a drawing of the catheter end  100  and bag end  200  connectors from Carefusion just before they are connected together. 
         [0031]      FIG. 6  is a drawing of the catheter end  100  and bag end  200  connectors from Carefusion when they are connected together. According to literature from Carefusion, there is an audible click when the two connectors are joined, indicating the presence of a locking mechanism. 
         [0032]      FIG. 7  is a drawing of only the bag end connector  200  from Carefusion showing a proximal end  202  for connection to the catheter end connector  100  and a distal end  206  for connection to tubing. 
         [0033]      FIGS. 8A-D  are drawings of a connector on the catheter end  100  of a fluid drainage system from Kimberly-Clark.  FIG. 8A  is a perspective view of the catheter end connector  100  showing the distal  106  and proximal ends  102 .  FIG. 8B  is a cross sectional view along the widest part of the catheter end connector  100  along the axis indicated in  FIG. 8D .  FIG. 8C  is a cross sectional view at 90 degrees to  FIG. 8B  along the axis indicated in  FIG. 8E .  FIG. 8D  is an exterior view of the orientation of the connectors in  FIG. 8C  and  FIG. 8E  is an exterior view of the orientation of the connectors in  FIG. 8B . 
         [0034]      FIGS. 9A-C  are drawings of a connector on the bag end  200  of a fluid drainage system from Kimberly-Clark.  FIG. 9A  is a perspective view of the connector showing the distal end  206  and proximal end  202 . The central stem  208  and tines  212  are also clearly visible.  FIG. 9B  is a cross sectional view of the connector and  FIG. 9C  is a top view of the connector looking down on the tine  212  at one side. 
         [0035]      FIGS. 10A-E  are drawings of the catheter end  100  and bag end  200  connectors from Kimberly-Clark when they are connected together.  FIG. 10A  is a perspective view of the two connectors when they are attached to each other.  FIG. 10B  is a cross sectional view along the narrowest part of the connectors along the axis indicated in  FIG. 10D .  FIG. 10C  is a cross sectional view at 90 degrees to  FIG. 10B  along the axis indicated in  FIG. 10  E.  FIG. 10D  is an exterior view of the orientation of the connectors in  FIG. 10C  and  FIG. 10E  is an exterior view of the orientation of the connectors in  FIG. 10B . 
         [0036]      FIGS. 11A-E  are drawings of an adapter that can be used between the connectors on the catheter end and the bag end of a fluid drainage system.  FIG. 11A  is a perspective view of the adapter showing the distal end  306  and proximal end  302  with its elongated portion  308 .  FIG. 11B  is a cross sectional view of the adapter  300  along the axis indicated in  FIG. 11D .  FIG. 11C  is a cross sectional view at 90 degrees to  FIG. 11B  along the axis indicate in  FIG. 11E .  FIG. 11D  is an exterior view of the orientation of the adapter  300  in  FIG. 11C  and  FIG. 11E  is an exterior view of the orientation of the adapter  300  in  FIG. 11B . 
         [0037]      FIGS. 12A-D  are drawings showing the interaction of the adapter and the connector on the bag end of a fluid drainage system from Kimberly-Clark.  FIG. 12A  is a perspective view of the adapter  300  and bag end connector  200  when they are attached to each other.  FIG. 12B  is a cross sectional view of the adapter  300  and connector  200  along the narrowest part of the connector  200  along the axis indicated in  FIG. 12D .  FIG. 12C  is a cross sectional view at 90 degrees to  FIG. 12B  along the axis indicated in  FIG. 12E .  FIG. 12D  is an exterior view of the orientation of the adapter  300  and connector  200  in  FIG. 12C  and  FIG. 12E  is an exterior view of the orientation of the adapter  300  and connector  200  in  FIG. 12B . 
         [0038]      FIG. 13  is a drawing showing the interaction of the adapter  300  and the catheter end connector  100  of a fluid drainage system from Carefusion with a bag end connector  200  of a fluid drainage system from Kimberly-Clark. 
         [0039]    The catheter end connectors  100  have a proximal end  102  for connecting to tubing  104  and a distal end  106  for connecting to the bag end connectors  200 . In some embodiments the catheter end connector  100  has a circumferentially ledge  112  that is used to hold the tines  212  of the bag end connector  200 . 
         [0040]    In like manner, the bag end connectors  200  have a proximal end  202  that connects to the distal end  106  of the catheter end connector  100  and a distal end  206  that connects to tubing  204  that terminates in the collection bag  210 . Some bag end connectors  200  have a central stem  208  that is inserted into the catheter end connector  100  to open the check valve within (not visible). The bag end connectors  200  have, in some embodiments, at least one set of tines  212  that are flexible enough to be spread apart slightly and then to spring back to approximately their original position. Finger pressure on the distal end  214  of the tines  212  is sufficient to separate them. The proximal end  216  of the tines  212  close on or latch onto the notch or ledge  112  of the complementary catheter end connector  100  to hold the catheter end connector  100  and bag end connector  200  together. The tines  212  may be easily unlatched from the ledge  112  by squeezing the distal end  214  of the tines  212  (opposite the ledge  112 ). 
         [0041]    As can be gleaned from the drawings, the catheter end connectors  100  and bag end connectors  200  of each manufacturer are incapable of being effectively connected to the complementary connector of another manufacturer. In an emergency, the connectors of different manufacturers can be held together with the hands, or perhaps taped together, but this is not a satisfactory method under normal circumstances. 
         [0042]    Disclosed herein is an adapter  300 , as shown in  FIG. 11 , which may be used to connect the bag end connector  200  of one manufacturer to the catheter end connectors  100  of others. The adapter has a proximal end  302  that connects to the distal end  106  of the catheter end connector  100  of certain manufacturers, like for example the catheter end connector  100  shown in  FIG. 5 . The adapter  300  has an elongated portion  308  on the proximal end  302  that may be inserted into the catheter end connector  100  of certain manufacturers to function as a stem and open the check valve within (not visible). 
         [0043]    In like manner, the adapter  300  has a distal end  306  that connects to the proximal end  202  of the bag end connector  200  of  FIG. 9 . The adapter also has a circumferential ledge  312  that may be used to latch the tines  212  of the bag end connector  200  of some embodiments. 
         [0044]    In one embodiment, the adapter  300  has a total length of about 1.53 inches (3.88 cm), the outer width of the elongated portion  300  is about 0.12 inches (0.3 cm), the outer width of the distal portion is about 0.52 inches (1.33 cm) and the ledge  312  onto which the tines  212  of the bag end connector  200  latch are about 0.52 inches (1.32 cm) from the distal end  206 . The width of the adapter at the inner part of the ledge is about 0.35 inches (0.9 cm). 
         [0045]      FIG. 12  shows the interaction of the adapter  300  with a bag end connector  200  having tines  212  of  FIG. 9 . In use, the adapter  300  is first inserted into the bag end connector  200  until the tines  212  latch onto the ledge  312  of the adapter  300 . The proximal end  302  of the adapter  300  is then inserted into the catheter end connector  100 . 
         [0046]      FIG. 13  shows the adapter  300  connected with the bag end connector  200  having tines  212  of  FIG. 9  and the catheter end connector  100  of  FIG. 5 . 
         [0047]    The connectors and adapters may be made from plastic materials. Suitable example materials include polyolefins, polyurethanes, nylons and the like. 
         [0048]    As used herein and in the claims, the term “comprising” is inclusive or open-ended and does not exclude additional unrecited elements, compositional components, or method steps. 
         [0049]    While various patents have been incorporated herein by reference, to the extent there is any inconsistency between incorporated material and that of the written specification, the written specification shall control. In addition, while the disclosure has been described in detail with respect to specific embodiments thereof, it will be apparent to those skilled in the art that various alterations, modifications and other changes may be made to the disclosure without departing from the spirit and scope of the present disclosure. It is therefore intended that the claims cover all such modifications, alterations and other changes encompassed by the appended claims.