Abstract:
An apparatus and method to effect a sterile interconnection of lines for transferring sterile medical fluids from a supply container to a fluid utilization device or a fluid storage container. A flexible, transparent, sterile connection bag is provided with at least three inlet/outlet ports. Previously sterilized free ends of the incoming and outgoing fluid lines, provided with connectors, are inserted into the bag through two of the ports and sealed therewith. A gas sterilization line is inserted into the bag through the third port. A sterilizing gas, such as ozone, is introduced into the bag to re-sterilize the lines and the connectors. Through visual inspection and external hand manipulation of the bag and its contents, the two lines are joined within the bag by the line connectors. Sterile fluid transfer through the lines is then undertaken.

Description:
BACKGROUND OF THE INVENTION  
       [0001]     1. Field of the Invention  
         [0002]     The invention relates generally to devices and methods for transferring sterile fluids from a fluid supply container to a fluid utilization device or a fluid storage container while maintaining the sterility of that fluid. More particularly, the invention pertains to an apparatus and a method in which: at least two sterile fluid transfer lines are inserted into a flexible, sterile connection bag which is either transparent or includes a transparent viewing window; a sterilizing gas, such as ozone, is introduced into the bag; the fluid transfer lines are manually interconnected within the bag by external hand manipulation; and, a sterile fluid is passed from one fluid transfer line to the other fluid transfer line.  
         [0003]     2. Description of the Prior Art  
         [0004]     Transferring sterile fluids from one vessel or container to another is a daily occurrence in hospitals, pharmacies, veterinary clinics, blood banks, research facilities, and medical supply companies. For example, bio-technology and bio-pharmaceutical companies utilize large volumes of sterile fluids when conducting research and producing medicine. In the course of this research and production, sterile fluids must be transferred from a large storage container to another container directly associated with the sterile fluid utilization. If contaminating bacteria is introduced into the means for fluid transfer, an entire research project or a batch of medicine in production may be lost.  
         [0005]     The containers which store and which receive transferred sterile fluids vary from plastic bags to stainless steel vessels, also known as bioreactors. Sterilized plastic bags are typically disposed of after one use. Stainless steel vessels, on t he other hand, are made the subject of multiple uses over a period of time. Therefore, vessels are sterilized, usually by steam, prior to use for storing or receiving sterile fluids. Tubes or hoses attached to these vessels by means of specialized connectors, are also sterilized at the same time. Fluid transfer tubes or hoses have protective covers over their ends to maintain sterility until their ultimate attachment to another vessel or a bag. Currently, the entire system must be sterilized, or re-sterilized, after all of the vessel, bag, and line connections have been made. Owing to the size of these components and the overall system, re-sterilization is a time-consuming and exacting practice. If re-sterilization could be limited only to interconnections made between fluid line tubes or hoses, much time and effort could be saved.  
         [0006]     In U.S. Pat. No. 4,242,310, issued to Greffet al., an apparatus designed to effect a sterile interconnection of the ends of sterile fluid lines is shown. In this arrangement, a rigid transparent housing having a hinged cover is provided. A flexible membrane within one wall of the cover allows sterile entry of a user&#39;s hand into the interior of the housing. Multiple fluid supply lines enter the housing, from fluid bags or sacks supported in an adjacent rack. An outflow fluid line also enters the housing, for interconnection to one of the two fluid supply lines. A sterilizing chemical agent or steam is introduced into the housing for sterilizing the various lines.  
         [0007]     However, the need still exists for an inexpensive yet fault-proof means for maintaining sterility throughout a sterile fluid transfer system, where that system includes connections or junctures between fluid transfer lines  
         [0008]     There is also a need for a lightweight, disposable, and inexpensive sterile connection bag or container where sterile interconnections can be made between incoming fluid lines and outgoing fluid lines.  
         [0009]     There is also a need for a sterile connection bag or container where sterile interconnections can be made between fluid lines through a combination of visual inspection and direct manual manipulation of fluid lines and their connectors through the wall of the sterile container.  
         [0010]     These and other objects of the present invention will be described in the drawings and in the detailed description of the preferred embodiment set forth below.  
       SUMMARY OF THE INVENTION  
       [0011]     The apparatus of the present invention comprises a flexible sterile connection bag or container, having a sidewall with a transparent portion therein. Also provided in the connection bag sidewall are a gas sterilization port, an incoming port, and an outgoing port . The free end of an incoming fluid line is passed through the incoming port, so that it extends into the interior volume of the connection bag. The free end of an outgoing fluid line is passed through the outgoing port, so that it extends into the interior volume of the connection bag. One of the free ends of the fluid lines may be provided with a line connector prior to its insertion into the connection bag. Alternatively, the line connector may independently be inserted into the connection bag through one of the open ports.  
         [0012]     A gas sterilization generator has an outlet connected to one end of a gas sterilization line. The other free end of the gas sterilization line is passed through the gas sterilization port to extend into the interior volume of the connection bag. The sterilizing gas is effective to re-sterilize all line and connector components within the interior volume of the connection bag.  
         [0013]     Following re-sterilization, the user of the apparatus views the line and connector components through the transparent portion of the sidewall. Utilizing hand manipulation applied through the flexible bag, the user then removes the protective caps on the free ends of the fluid lines and the connector. Similarly, the incoming and outgoing fluid lines are manually connected, and the fluid lines are ready for sterile transfer of the fluid. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0014]      FIG. 1  is a perspective view of a fluid supply container, an ozone generator, a fluid storage bag, interconnected to the sterile connection bag of the present invention;  
         [0015]      FIG. 2  is a perspective view of the sterile connection bag, showing the incoming fluid line, and outgoing fluid line, and the ozone line  
         [0016]      FIG. 3  is a view as in  FIG. 2 , but showing the ozone line connected to an inlet line, and the fluid lines inserted into the sterile connection bag with their protective caps removed;  
         [0017]      FIG. 4  is a cross-sectional view, taken on the line  4 - 4  in  FIG. 5 ;  
         [0018]      FIG. 5  is a detailed view of a friction-fitted port plug in proximity to a fluid line;  
         [0019]      FIG. 6  is detailed view of an alternative construction for a port plug including external threads, the plug being shown installed over a fluid line;  
         [0020]      FIG. 7  is a view as in  FIG. 3 , but showing the fluid lines interconnected with a standard male and female line coupler;  
         [0021]      FIG. 8  is an alternative construction for the sterile connection bag, showing another port accommodating a second incoming fluid line and using barbed line couplers; and,  
         [0022]      FIG. 9  is a view as in  FIG. 8 , but showing the outgoing fluid line now interconnected to the second incoming fluid line. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0023]     Turning now to the drawings, and in particular to  FIG. 1 , the apparatus  11  of the present invention includes a flexible sterile connection bag  12 . Connection bag  12  is preferably made entirely from a transparent material, such as a plastic, vinyl, or polyvinyl. However, to utilize the apparatus  11  effectively, it is only necessary that a sidewall of bag  12  have at least a portion  13  which is transparent, so as to enable the user to view the line and connector components within the contained volume of bag  12 .  
         [0024]     The connection bag  12  includes three ports which penetrate through its sidewall and extend into the inner, contained volume of the bag. These ports comprise a gas sterilization port  14 , an incoming port  16 , and an outgoing port  17 . Once gas and fluid lines are installed in these ports, as explained more fully below, the connection bag  12  is hermetically sealed.  
         [0025]     A tube stub  18  is passed through gas sterilization port  14 , and a snug fit ensures a reasonably tight seal therewith. Stub  18  includes a male connector  19  on its exterior end, while its free end  20  extends into the contained volume of the connection bag  12 . A gas sterilization generator  21  has a gas outlet  22  connected to one end of a gas sterilization line  23 . Gas sterilization generator is a commercially available apparatus, preferably producing ozone or other gas capable of creating a sterilizing environment in a sealed container. A female connector  24  is provided on the other end of line  23 , for ready interconnection to male connector  19 . A conventional line clamp  26  may also be provided on line  23 , to control the discharge of sterilizing gas through the line. Typically, protective caps  27  and  28  are respectively provided over connectors  19  and  24  to maintain the sterility of their connection portions up to the time the interconnection between them is made.  
         [0026]     It may also be desirable, under certain conditions, to provide a gas sterilization line  29  which extends continuously from the outlet  22  of gas sterilization generator  21 , directly into the contained volume of bag  12 . In this arrangement, as shown in  FIGS. 8 and 9 , the line  29  is simply inserted through port  14 , and no external male and female line connectors are used. Line  29  may also be permanently connected to and sealed within port  14 , so that the bag  12  would effectively be pre-fitted with a gas sterilization line.  
         [0027]     A sterilized fluid supply container  31  includes a discharge valve  32 . Container  31  may be a stainless steel vessel, a tank, or a plastic bag, depending upon the sterilized fluid and the storage requirements. An incoming fluid line  33  has one end connected to discharge valve  32  and a free end  34  fitted with a male connector  36 . Male connector  36  is pre-sterilized and fitted with a protective cap  27 , as shown in  FIG. 2 . Protective cap  27  remains on connector  36  until the final connection step within connection bag  12  is undertaken. A line clamp  35  may be provided over line  33 , further to control the flow of fluid therethrough.  
         [0028]     A friction-fitted port plug  37  is provided to ensure a tight seal between fluid line  33  and incoming port  16 . Plug  37  is preferably made from a resilient material which is capable of being compressed to some degree, as it is inserted into incoming port  16 . To facilitate its installation, plug  37  is tapered slightly in its exterior diameter, from outer side  38  to inner side  39 , as shown in  FIG. 4 . Plug  37  is provided with ribs  41  around a tube aperture  42  to form a tight seal over line  33 . A slit  43  is provided in the side of plug  37 , to ensure easy installation over line  33 . As shown in  FIG. 3 , with the free end  34  of line  33  within the contained volume of bag  12 , plug  37  is installed over line  33  and then pressed snugly into incoming port  16 .  
         [0029]     As an alternative construction, a port plug  44  including external threads  46  on its outer periphery may be employed as well. This construction also includes a slit  43  and ribs  41  (not shown) so it forms a tight seal and is readily installed over line  33 . In addition, incoming port  16  must be provided with internal threads (not shown) so that plug  44  may be threadably engaged within port  16  while securing line  33  within bag  12 .  
         [0030]     It is apparent that many other constructions may be used to effect the required airtight interconnection between the fluid line and the port interconnection. For example, an internally threaded cap which passes the fluid line may be adapted to mate with an externally threaded port extension. Also, a snap-on male/female connector system provided with sealing 0-rings may be employed. Both of these connection arrangements are conventional and well known in the art, so no further description is needed.  
         [0031]     On the other side of connection bag  12 , an outgoing fluid line  47  is inserted through outgoing port  17 , with its free end  48  extending into the contained volume of connection bag  12 . A female connector  49 , fitted with a protective cap  28 , is provided on free end  48 . The other end of outgoing fluid line  47  extends to a fluid storage bag  51 . Depending upon the particular application, a fluid storage vessel or a fluid utilization device may be substituted for fluid storage bag  51 . A line clamp  52  may be provided over line  47  to control outgoing fluid flow. As with the installation of line  33  within incoming port  16 , a port plug  37  is fitted over outgoing fluid line  47  and installed within outgoing port  17  to ensure a tight seal therebetween.  
         [0032]     At this juncture, sterilizing gas produced by the generator  21  is introduced into the contained volume of the bag, providing in effect a re-sterilization and maintenance of sterilization, of all lines and components therein. This process may take some ten to fifteen minutes to complete. Once re-sterilization is complete, the actual interconnection between the incoming fluid line  33  and the outgoing fluid line  47  is made. In preparation, while viewing the components through the transparent portion of the bag  12 , the user manually grips the protective caps  27  and  28  and removes them from their respective connectors. Owing to the flexibility and at least partial transparency of the bag  12 , manually gripping and manipulating components within the contained volume of the bag is an easy process for the user. With the protective caps removed, male connector  36  and female connector  49  are interconnected. See,  FIG. 7 .  
         [0033]     After the fluid line interconnection is complete, the required valves and clamps are opened to allow passage of the sterilized fluid from the container  31 , through the incoming and outgoing lines  33  and  47 , to the fluid storage bag  51 .  
         [0034]     Several alternative features are shown in the connection bag  53 , illustrated in FIGS.  8  and  9 . Connection bag  53  includes a gas sterilization port  14  and its associated gas sterilization line  29  leading to a gas sterilization generator  21  as previously described. However, connection bag  53  includes first incoming port  54  and second incoming port  56 . A first incoming line  57  and a second incoming line  58  are also provided, along with their respective port plugs  37 . Line  57  has a free end  59  and line  58  has a free end  61 , both free ends extending into the contained volume of bag  53 . A barbed connector  62  is provided on free end  59 , and a barbed connector  63  is provided on free end  61 . Preferably, barbed connectors  62  and  63  are pre-installed on lines  57  and  58 , sterilized, and then fitted with protective caps  27  before the lines are inserted into bag  12 .  
         [0035]     An outgoing line  64  having a free end  66  is installed through outgoing port  67 , in a manner identical to that previously described. Outgoing line is connected to a fluid tank, bag, or fluid utilization apparatus (not shown). Ozone or other sterilizing gas is introduced into the contained volume of bag  53  until all components and the lines are re-sterilized. As set forth above, owing to the transparent and flexible characteristics of the bag  53 , the user is capable of viewing the internal components and lines, while grasping and manipulating the components and lines for selective interconnecttion. Then, protective caps  27  are removed from barb  62  and free end  66 , and barb  62  is then inserted into free end  66  of outgoing line  64 . See,  FIG. 8 . Finally, fluid is allowed to pass in a sterilized condition, from incoming line  57  to outgoing line  64 .  
         [0036]     If the supply of fluid provided to incoming line  57  is exhausted, or if a different fluid is desired to be provided to outgoing line  64 , a simple line changeover is undertaken. Sterilizing gas may again be introduced into bag  53 , to ensure re-sterilization of the contained lines and components. Again manipulating the contained lines and components, the user removes the protective cap  27  from barb  63  or from free end  61 , withdraws free end  66  from barb  62 , and inserts free end  66  into barb  63 , as shown in  FIG. 9 . Then, fluid flow can begin, transferring fluid from incoming line  58  through outgoing line  64 .