Patent Publication Number: US-8123738-B2

Title: Closed system connector assembly

Description:
This application is a Division of pending application Ser. No. 10/236,147 filed Sep. 6, 2002, now U.S. Pat. No. 7,004,934. 
     This application claims the priority benefit of Provisional Patent Application 60/317,143 filed Sep. 6, 2001. 
    
    
     This invention relates to a closed system connector assembly. More particularly, this invention relates to a closed system connector assembly having a swabable male adaptor and a swabable female connector for use particularly in the health care industry. 
     As is known, the health care industry is concerned with microorganisms, such as bacteria and the like, which may cause health problems. In some cases, people become patients because these microorganisms become unmanageable and threaten or endanger the health of the patient. 
     Patients requiring therapy are often placed in a position where their normal defenses against microorganisms are compromised. As a result, the patients may develop nosocomal infections while being treated for another disease during therapy. As has been recognized, a major cause of nosoicomal infections has been due to the connection/disconnection of tubing lines, especially in the area of IV therapy. This is one of the reasons why most IV Administration Sets (IV tubing with connectors) are discarded every forty-eight to seventy two hours. 
     In the development of connectors for tubing lines, primary concern has generally been with having a connector which can readily be closed and sealed and just as readily be opened with a minimum of force. A so-called luer connection is the generally accepted standard for the health care industry. This connector is easy to open and close and requires little force while at the same time providing a positive seal. However, one disadvantage of this connector is that after fluid flows through a connection made by the connector, if the user wishes to open the connection and then reconnect the connection, the chance of microorganism contamination is sufficiently large that most hospitals do not allow this practice except under abnormal circumstances. 
     In order to provide a system, which can be connected, for the transfer of medication, followed by a sterile disconnection, the use of a Y-site connector has been developed. In this case, the connection is in the form of a plastic fitting having one end covered with a rubber septum. In order to deliver fluid into the connector, a sterile needle pierces through the rubber septum in order to transfer fluid into the line to which the connection is connected. After fluid transfer is completed, the needle is removed and the rubber septum self closes to maintain what is commonly referred to as a closed system and sterility of the line is maintained. Everything associated with the now removed needle is considered to be non-sterile since the exit port of the needle is exposed to the atmosphere and almost immediately becomes contaminated. 
     U.S. Pat. No. 5,122,123 describes a product, which has membranes on both parts of the connection assembly. One part further contains a cannula, which has about it a membrane, which is collapsible. Upon joining the two portions of the connector together, the one membrane collapses as the cannula enters the other portion of the connector thereby opening the septum and providing for a continuous passage for fluid flow. Upon disconnect, the cannula is resheathed within the membrane prior to removal thereby maintaining a sterile path within both portions of the connector assembly. This assembly requires two connector halves, which are uniquely designed to mate with each other. As a result, existing connector products are generally not viable when a connector half does not contain a membrane or the membrane opens when the central portion of the connector is forced inward by the action of a male luer adaptor. 
     Accordingly, it is an object of this invention to provide a connector assembly, which can be readily made sterile on site immediately prior to forming a connection. 
     It is another object of this invention to provide a connector, which can be used with existing available connectors to achieve a sterile connection/disconnection. 
     Briefly, the invention provides a closed system connector assembly comprising a male adaptor attached to a female connector. The female connector may be a needleless type generically described as a pressure opening swabable valve that opens upon the attachment of a male luer connector portion. Swabable valves of the needleless type include the CLC 2000 made by ICU Medical, POSIFLOW, made by Becton Dickinson. Other valves of this type are made by B. Braun and Kippmed to name a few. 
     The male adaptor of this invention is constructed with a tubular portion to define a lumen and a membrane or septum at one end of the tubular portion for sealing the lumen. 
     The female connector to which the male adaptor connects has a housing defining a lumen and a membrane or equivalent surface that may be swabbed to achieve a sterile interface for sealing the lumen and for abutting the membrane of the male connector. 
     Upon movement of the male adaptor against the female connector swabable face (membrane), the membrane covering the nose of the male adaptor is opened exposing the tubular lumen which enters the female connector housing. As the nose portion moves into a housing of the female connector, the female connector housing lumen is opened to provide fluid communication between the connectors. The face portion of the male adaptor membrane engages the flange or face of the female connector housing forming a seal between the two connectors with the outside environment. Upon uncoupling, the female connector closes prior to removal of the nose portion of the male adaptor. As the male adaptor disengages from the female connector, the septum closes prior to the exposure of the male lumen to the environment thereby maintaining a sterile fluid path in both the male adaptor and the female connector. 
     In this manner, a sterile connection is achieved with an existing needleless pressure opening connector which is swabable to achieve sterility at the face prior to use. The closed system connector allows a sterile connection to be achieved many times by simply swabbing both system connector halves prior to connection. 
     In another embodiment, the female connector may include a hollow needle disposed within the lumen that is positioned for entry into the lumen of the male adaptor. 
    
    
     
       These and other objects and advantages of the invention will become more apparent from the following detailed description taken in conjunction with the accompanying drawings wherein: 
         FIG. 1  illustrates a cross-sectional view of the male adaptor portion of a closed system connector constructed in accordance with the invention with a reseal member thereof in a first, closed position; 
         FIG. 2  illustrates a cross sectional partial view of a commercial needleless connector; 
         FIG. 3  illustrates a cross sectional view of the male adaptor of  FIG. 1  in abutment with the female connector of  FIG. 2 ; 
         FIG. 4  illustrates a cross sectional view of the male adaptor of  FIG. 1  penetrating the female connector of  FIG. 2 ; 
         FIG. 5  illustrates a cross sectional view similar to  FIG. 4  with of a portion of the swabable membrane of the male adaptor opened and pushed up the housing of the male adaptor. 
         FIG. 6  illustrates a cross sectional view of a portion of a swabable valve which has a central mandrel; 
         FIG. 7  is a cross sectional view of the swabable valve of  FIG. 6  connected to the tubular portion of the male adaptor of  FIG. 1 ; 
         FIG. 8  illustrates a cross-sectional view of needle containing female connector; and 
         FIG. 9  illustrates a cross-sectional view of the female connector of  FIG. 8  connected to a male adaptor of  FIG. 1 . 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring to  FIG. 1 , the male adaptor  10  includes a housing  18  having a projecting nose or tubular portion  14  and a passage or lumen  15  that extends centrally therethrough. As illustrated the outer surface of the nose  14  is tapered downwardly towards the forward end. 
     In addition, the adaptor  10  has a locking ring  11  mounted concentrically of the nose  14  that is provided with an internal thread  20 . The locking ring  11  is locked in place on the nose  14  by the relative dimensions of an integral ring  16  on the nose  14  and an internal ring or collar  17  on the end of the locking ring  11 . The ring  16  has a greater outside diameter than the inside diameter of the ring  17  to create an interference fit preventing the locking ring  11  from moving along the nose  14 . The locking ring  11  in this embodiment is free to rotate about the axis of the nose  14 . 
     A septum or membrane  12  is mounted on the nose  14  to close over the passage  15 . This septum  12  includes a disk-shaped body  12 ′ sealing over the passage  15  and a tubular sleeve  12 ″ that extends over the nose  14 . The disk-shaped body  12 ′ has a flat swabable surface coincident with the end of the locking ring  11 . As such, the face of the septum  12  can be easily swabbed prior to use. 
     As illustrated, the septum  12  has an internal flange at one end that fits into an annular groove  41  in the nose  14  to secure the septum  12  in place. In addition, the septum  12  has a weakened section  13 , such as a slit or pierced point, centrally of the disk-shaped body  12 ′ that is in line with the passage or lumen  15 . 
     The housing  18  is typically sterilized and may be connected to a tubing or have an end connector (not shown) for attachment to a fluid source for administration. 
     Referring to  FIG. 2 , the female connector  19  is in the form of a needleless injection site. As indicated, the female connector  19  includes a hollow housing  24  with an external thread  21  for threading of the locking ring  11  thereon (see  FIG. 5 ). As indicated in  FIG. 5 , the forward end of the housing  24  has an internal wall that is tapered to receive the tapered nose  14  of the male adaptor  10 . 
     In addition, the female connector  19  has a centrally disposed tubular member  28  disposed concentrically within the housing  24  to define a passage or lumen therethrough. The tubular member  28  carries a segmented sleeve  23  that is slidably mounted thereon under the bias of a spring (not shown) to move from a retracted position, as shown in  FIG. 5 , to an extended position, as shown in  FIG. 2 . The sleeve  23  is formed with a plurality of leaf spring-like elements that project beyond the tubular member  28  and that are bent or angled radially inwardly for purposes as described below. 
     A septum or membrane  22  is mounted on the segmented sleeve  23  to seal off the lumen of the tubular member  28 . As shown, the septum  22  has a flat disk-like body  22 ′ with a flat face at the entry to the housing  24 , a bulbous portion  22 ″ extending into the segmented sleeve  23  and a tubular sleeve  30  fitted over the segmented sleeve  23  and secured thereto in a suitable manner. The flat face of the body  22 ′ of the septum  22  is coincident with a face  51  of the housing  24  so as to be swabable prior to use. In addition, the flat body  22 ′ of the septum  22  has slit  29  aligned with the passage in the tubular member  28 . 
     As illustrated, the body  22 ′ of the septum  22  is slidably received in the tapered forward end of the housing  24  and forms a seal thereat. In addition, the housing  24  has a recessed portion  35  of greater inside diameter than the forward portion to accommodate expansion of the segmented sleeve  23  as explained below. 
     Referring to  FIG. 3 , wherein like reference characters indicate like parts as above, prior to connecting the male adaptor  10  and the female connector  19 , the respective septums  12 ,  22  of each component is swabbed for sterilization purposes. Next, the male adaptor  10  is brought up against the female connector  19 . At this time, the septum  12  of the male adaptor  10  abuts against the septum  22  of the female connector  19  to maintain a sterile contact. At the same time, the outer periphery of the flat body  12 ′ of the septum  12  abuts against the face  51  of the housing  24 . 
     Next, the male adaptor  10  is pushed towards the female connector  19 . At this time, the nose  14  of the male adaptor  10  being of less outside diameter than the inside diameter of the connector housing  24  causes the flat body  12 ′ of the septum  12  to distort so that the slit  13  dilates to thereby open to allow penetration of the nose  14  into the housing  24  the female connector  19 . At this time, the housing  24  of the female connector  19  pushes the dilated body  12 ′ of the septum  12  along the nose  14  as indicated in  FIG. 5  to a retracted position. In this position, the sleeve  12 ″ of the septum  12  resiliently collapses into a bellows shape. 
     Further, as the nose  14  penetrates the housing  24  of the female connector  19 , the septum  22  therein is pushed rearwardly into the recessed portion  35 . At this time, the sleeve  23  is also pushed rearwardly so that the inwardly bent leaf spring elements of the segmented sleeve  23  expand radially outwardly as they pass over the end of the tubular member  28 . This in turn, causes the slit  29  of the septum  22  to dilate to form a passage  31 . In this way, the passage  15  of the male adaptor  10  comes into communication with the lumen of the tubular member  28  to allow fluid to pass therebetween. 
     Continued movement of the nose  14  into the connector  19  causes the leaf spring elements to flex further outwardly to the condition shown in  FIG. 5  thereby further dilating the passage  31 . 
     When the leaf spring elements of the segmented sleeve  23  are in the position illustrated in  FIG. 3 , the forward end of the housing  24  prevents outward flexing of the leaf spring elements. 
     As indicated in  FIG. 5 , the resiliently collapsed septum  12  maintains a seal tight fit against the face  51  of the housing  24  of the female connector during the connection process of the male adaptor  10  to the female connector  19 . 
     Upon disconnecting the male adaptor  10  from the female connector  19 , the nose  14  retracts from the body  22 ′ of the septum  22 . The leaf spring elements then flex inwardly causing the body  22 ′ to circumferentially collapse to a diameter sufficient to allow passage of the body  22 ′ into the forward end of the housing  24 . Continued withdrawal of the nose  14  from the housing  24  allows the segmented sleeve  23  to be spring biased back to the extended position of  FIG. 3 . At this time, the leaf spring elements of the segmented sleeve  23  also collapse back into the position illustrated in  FIG. 3  so that the septum body  22 ′ closes and again seals against the inside wall of the housing  24  thereby maintaining the female connector  19  in a sterile condition. 
     As the nose  14  is being withdrawn from the housing  24  the female connector  19 , the sleeve  12 ″ of the septum  12  expands from the position of  FIG. 5  towards the position indicated in  FIG. 3  while remaining in sealing contact with the housing  24 . As the nose  14  achieves the position shown in  FIG. 3 , the body  12 ′ of the septum  12  closes over the passage  15  of the nose  14  while remaining in contact with the face  51  of the connector  24 . This maintains the passage  15  of the male adaptor  10  in a sterile condition. 
     Referring to  FIG. 4 , wherein like reference characters indicate like parts as above, the locking ring  11  may be mounted over the nose  14  of the male adaptor without being locked thereon. In this embodiment, the locking ring  11  is free to move axially relative to the nose of the adaptor. Thus, the locking ring  11  may be threaded onto the female connector  24  before the nose  14  of the male adaptor is pushed into the housing  24  of the female connector. 
     The locking ring  11  may be mounted on the male adaptor and held in place by posts (not shown) on the housing  18  that align with key locks (not shown) on the internal flange of the locking ring  11 . When the posts align with the key lock, the locking ring  11  may be moved axially relative to the housing  18 . 
     Referring to  FIG. 6 , the female connector may be constructed with a housing  51  having an external thread within which a mandrel  54  is slideably mounted. As indicated, the mandrel  54  has an inclined face  53  and is sealed relative to the forward end of the housing  51  by a sealing ring  52 . In addition, the housing  51  is provided with a recess  57  in order to form an annular space or gap between the housing  51  and the mandrel  54  for the passage of fluid. 
     Referring to  FIG. 7 , wherein like reference characters indicate like parts as above, as the tapered nose  14  of the male adaptor  10  is pushed into the housing  51  of the connector, the mandrel  54  is pushed backwardly in order to expose the annular gap between the housing  51  and the mandrel  54  to the passage  15  in the male adaptor  10 . As above, the septum  12  on the male adaptor  10  moves up the tapered nose  14  thereby opening the septum  12  while maintaining a seal between the septum  12  and the face of the housing  51 . 
     Referring to  FIG. 8 , the female connector may be constructed with a tubular housing  61  having an external thread and a hollow needle  62  disposed concentrically within the housing  61 . In addition, a tubular member  63  is disposed concentrically between the housing  61  and the needle  62  to define a passage  64  therethrough. In addition, a septum  65  is formed integrally with the tubular member  63  to seal off the passage  64 . This septum  65  also has a centrally disposed slit  69  and a ring  66  disposed circumferentially of the septum  65  to maintain a compressive force on the slit  69  to maintain the slit  69  closed. 
     Referring to  FIG. 9 , wherein like reference characters indicate like parts as above, when the male adaptor is inserted into the connector of  FIG. 8 , the septum  65  is pushed backwardly from the position shown in  FIG. 8  to allow the needle  62  to pass through the slit  69  of the septum  65 . To this end, the needle has an opening  67  in a side wall and a blunt end  68  to avoid coring of the septum  69 . 
     As shown in  FIG. 9 , the tubular member  63  collapses resiliently into a bellows shape. Upon retraction of the male adaptor, the tubular portion  63  springs back into the condition illustrated in  FIG. 8  to allow the septum  65  to again seal off the passage  64 . 
     The invention thus provides a male adaptor which is able to maintain a sealed passageway for fluids during coupling with and uncoupling from a female connector. 
     Further, the invention provides a closed system connector assembly wherein a male adaptor and a female connector may be readily made sterile on site immediately prior to performing a connection and maintained sterile after disconnection.