Abstract:
A method for forming an aseptic connection includes inserting an end of a sealed fill connector into a receptacle of an aseptic connector assembly; moving a pivot portion of the aseptic connector assembly relative to a body portion of the aseptic connector assembly so as to sever a portion of the fill connector, the pivot portion being at least partially disposed within the body portion; and advancing a conduit portion of the aseptic connector assembly into the fill connector so as to form an aseptic connection therebetween, the conduit portion being at least partially disposed within the pivot portion or the body portion of the aseptic connector assembly after advancing.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a divisional of U.S. application Ser. No. 14/476,900, filed on Sep. 4, 2014, which claims priority to, and the benefit of, U.S. Provisional Patent Application No. 61/979,685, filed Apr. 15, 2014, which are hereby incorporated by reference in their entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention relates to connectors for fluid transport and more particularly to a connector for the aseptic transfer of fluids from one location to another. 
       BACKGROUND OF THE INVENTION 
       [0003]    Flexible containers are commonly used for containment and delivery of medical fluids. These containers are generally single use bags manufactured from one or more types of plastic film that can be irradiated or otherwise withstand sterilization such that the container can be rendered aseptic. The containers are often used in life science applications and in the manufacture of pharmaceuticals to contain liquid raw materials prior to or during manufacture; in other cases such containers may be used to contain the finished product. The contents of these containers may be precious, particularly when used in large scale production. It is not unusual for even small containers to contain material worth many thousands of dollars. 
         [0004]    Furthermore, it is important that the fluids be capable of quick and efficient transfer between containers, such as from a large capacity container to smaller containers for sale or consumption, without compromising the sterility during transfer. The need to transfer fluids in sterile conditions introduces additional complications in keeping fluid within a controlled, sterile environment. 
         [0005]    Various attempts have been made to deal with this issue and one system, the ASI Filling System commercially available from Advanced Scientifics, Inc. of Millersburg, Pa., can be used to yield an aseptic bag fill. The ASI Filling System is described in U.S. Pat. No. 7,530,374, which is incorporated herein by reference. 
         [0006]    While this system presents a satisfactory solution for achieving an aseptically filled container, it is desirable to further enhance the functionality of this and other aseptic filling systems. 
       BRIEF DESCRIPTION OF THE INVENTION 
       [0007]    Exemplary embodiments do so by providing a connector that can be used to subsequently evacuate those containers in an aseptic manner that accomplishes the filling and subsequent evacuation of the container via the same port, resulting in a more robust system. 
         [0008]    In one embodiment, an aseptic connector assembly includes a body portion, the body portion having a receptacle configured to receive a corresponding fill connector; a pivot portion adjustably disposed within and extending partially from the body portion, the pivot portion having a channel formed therein; and a conduit portion axially slidably disposed within the channel formed in the pivot portion. The pivot portion comprises a ready position and an operative position, the pivot portion being adjustable from the ready position to the operative position via relative movement with respect to the body portion. 
         [0009]    In another embodiment, a fluid transfer assembly includes the aseptic connector assembly, and a fluid container connected to the aseptic connector, the fluid container including a fill connector extending therefrom. 
         [0010]    In another embodiment, a method of aseptically transferring fluid includes providing an aseptic connector in a ready position, the aseptic connector including a body portion, the body portion having a receptacle configured to receive a corresponding fill connector, a pivot portion adjustably disposed within and extending partially from the body portion, the pivot portion having a channel formed therein, and a conduit portion axially slidably disposed within the channel formed in the pivot portion; coupling a flexible tubing to the conduit portion; coupling the fill connector to the receptacle; moving the pivot portion to an operative position and aligning the conduit portion with the receptacle; axially sliding the conduit portion into an opening in the receptacle, establishing a continuous fluid flow path through the aseptic connector; and transferring a fluid from a fluid source, through the aseptic connector, to a container. 
         [0011]    An advantage of exemplary embodiments is that fluids can be aseptically transferred without sterilizing an exterior of a container from which the fluids are being transferred. 
         [0012]    Another advantage is that rotation of the aseptic connector removes a cap from a fill connector of a container and exposes a septum, the septum providing a secondary barrier to the environment. 
         [0013]    Yet another advantage is that after removing the evacuated container, the aseptic connector maintains the sterility of the tube and/or container to which the fluids were transferred. 
         [0014]    A further advantage is that the aseptic connector includes a stop to prevent repeated use of the aseptic connector after the evacuated container has been removed. 
         [0015]    Other features and advantages of the present invention will be apparent from the following more detailed description of exemplary embodiments that illustrate, by way of example, the principles of the invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]      FIG. 1  is a perspective view of an aseptic connector, according to an embodiment of the disclosure. 
           [0017]      FIG. 2  is a cross-sectional view of the aseptic connector of  FIG. 1 . 
           [0018]      FIG. 3  is a perspective view of an aseptic connector attached between a flexible container and flexible tubing. 
           [0019]      FIG. 4  is a schematic view of the operation of an aseptic connector. 
           [0020]      FIG. 5  is a perspective view of a dial type aseptic connector, according to an embodiment of the disclosure. 
           [0021]      FIG. 6  is a perspective view of a sliding type aseptic connector, according to an embodiment of the disclosure. 
       
    
    
       [0022]    Wherever possible, the same reference numbers will be used throughout the drawings to represent the same parts. 
       DETAILED DESCRIPTION OF THE INVENTION 
       [0023]    Referring to  FIGS. 1 and 2 , an aseptic connector  100  includes a body portion  101 , a pivot portion  103 , and a conduit portion  105 . The conduit portion  105  is axially slidably disposed within a channel  107  formed in the pivot portion  103 . In one embodiment, the pivot portion  103  is adjustably disposed within, and partially extends from, the body portion  101 . A thin layer of a soft, sealing material may be disposed intermediate a region of the outer surface of the pivot portion  103  and the inner surface of the body portion  101  to act as a seal, preventing leaks and maintaining sterility. This and other seals are optionally included within the connector as desired. 
         [0024]    In one embodiment, the aseptic connector  100  is pivotable in a single direction, transitioning from a ready position (as shown in  FIG. 1 ), to an active position (i.e., fill/evacuate position) and from that position to a closed position as will be described in more detail subsequently. In another embodiment, the body portion  101  may be configured with travel stops to establish a range of motion for the pivot portion  103  between the ready, active, and/or closed positions, defining single directional movement between positions and preventing over or under rotation. The travel stops may further provide a palpable signal to the user that the aseptic connector  100  is in the proper position. In a further embodiment, the aseptic connector  100  is a single use aseptic connector, including a feature for preventing re-use of the aseptic connector  100  for another connection after removal. 
         [0025]    The aseptic connector  100  may be formed from any material suitable for sterilization. Suitable materials include, but are not limited to, plastic resins, preferably those selected from grades suitable for medical and/or life science use (e.g., materials class VI) and which are also resistant to high temperatures and gamma radiation to permit steam and/or gamma sterilization procedures that render the aseptic connector sterile prior to use. In one embodiment, sterilization of the aseptic connector  100  may be accomplished through autoclave sterilization at 270° F. (132° C.) for 60 minutes. In another embodiment, the aseptic connector  100  is resistant to up to 25 or more repetitions of the sterilization. Other embodiments include sterilization through gamma irradiation, e-beam sterilization, EtO sterilization, or a combination thereof. For gamma irradiation and/or e-beam sterilization, the aseptic connector  100  is resistant to a maximum cumulative exposure of up to 50 Kilograys. For EtO sterilization, the aseptic connector  100  is resistant to 100% EtO at 110° F. (43° C.) for up to five repetitions. It will be appreciated that sterilization should be done in an uncoupled position. 
         [0026]    As illustrated in  FIG. 2 , the conduit portion  105 , which is shown as a male connection, is connected to flexible tubing  205  to extend the fluid flow path to some other container or other location to which the fluid is to be delivered. The conduit portion  105  may include a raised wall  207  to provide a travel stop, the travel stop establishing an appropriate overlap length of the tubing  205 . The conduit portion  105  may also include one or more raised ribs  208  and/or a flared outlet  209  to aid in retaining the tubing  205  securely on the conduit portion  105  during use. Additionally, the one or more raised ribs  208  and/or the flared outlet  209  reduce the possibility of leaking that would thereby compromise the aseptic nature of the fluid path. 
         [0027]    The aseptic connector  100  also includes a receptacle  210  formed in the body portion  101 . The receptacle  210  is configured to receive a fill connector  212  appended to a fluid source, such as a filled flexible container or other suitable container  301  (see  FIG. 3 ) from which liquid is to be aseptically evacuated. For example, in one embodiment, the aseptic connector  100  includes a female receptacle configured to receive a male fill connector of the container  301 , thus connecting the aseptic connector  100  to the container  301 . In another embodiment, receptacle  210  of the aseptic connector  100  directly connects with the fill connector  212  through any suitable connection mechanism. Suitable connection mechanisms include, but are not limited to, a threaded connection, a trapezoid thread on the outer diameter of the fill connector  212 , a locking or snapping connection, or a combination thereof. In a preferred embodiment, the fill connector  212  is of the type described in U.S. Pat. No. 7,530,374 and/or those used in the flexible containers sold by Advanced Scientifics of Millersburg, Pa. which are adapted to interface with attachments. 
         [0028]    In the ready configuration shown in  FIG. 2 , a recess  214  in the pivot portion  103  is aligned with receptacle  210 . The recess  214  is configured to receive a cap  216  of the fill connector  212  when the fill connector  212  is attached to the receptacle  210 , and the aseptic connector  100  in the ready position. Together, the aseptic connector  100 , the fill connector  212  attached to the receptacle  210 , and the container  301  extending from the fill connector  212  form a fluid transfer assembly. Even with the aseptic connector  100  secured in its position along the fluid flow path, the body portion  101  is not in fluid communication with the conduit portion  105  when the aseptic connector  100  is in the ready position. As body portion  101  is not in fluid communication with the conduit portion  105 , the flexible container  301  is not in fluid communication with the flexible tubing  205  for the flow of liquid content therethrough. 
         [0029]    Referring to  FIG. 3 , the aseptic connector  100  is shown in its active, evacuate position, in which the pivot portion  103  is rotated into a position that aligns the conduit portion  105  residing in the channel  107  of the pivot portion  103  with the opening in the female receptacle  210 . The aligning of the conduit portion  105  with the female receptacle  210  also aligns the conduit portion  105  with the fill connector  212  attached thereto. In addition, the rotation of the pivot portion  103  from the ready to the active position breaks the fill connector cap  216  away from the fill connector  212 . In one embodiment, for example, the rotation of the pivot portion  103  disengages the cap  216  with ten pounds of force or less. The breaking away of the cap  216  exposes a septum  218  in the fill connector  212  as a secondary barrier to the environment. Because this interface of the aseptic connector  100  and fill connector  212  was not exposed to the environment, it remains a sterile portion of a closed pathway. 
         [0030]    After the aseptic connector  100  has been placed in the active position, and the conduit portion  105  is aligned with the receptacle  210 , the conduit portion  105  can be moved axially into the fill connector  212 . A taper  221  (see  FIG. 2 ) or spike may be formed at the proximal end of the conduit portion  105  to more easily penetrate any septum  218  that underlies the cap  216  of the fill connector  212 . In one embodiment, the wall  207  on the outer diameter of the conduit portion  105  is conveniently used to also establish the proper penetration depth of the conduit portion  105  through the body portion  101  into the fill connector  212 . For example, the wall  207  on the conduit portion  105  may establish the proper penetration depth by contacting a complementary wall  109  (see  FIGS. 1 and 2 ) of an extension of the pivot portion  103 . In addition to or in place of the wall  207 , any other mechanism by which the depth of the conduit portion  105  into the fill connector  212  can be controlled may be used. A mechanical stop may also be employed in the pivot portion  103  and/or the conduit portion  105  to prevent the conduit portion&#39;s  105  unintentional removal from the aseptic connector  100  (for example, when retracting the conduit portion from the fill connector after use). 
         [0031]    Once the conduit portion  105  has been moved axially into the fill connector  212  and/or the septum  218  is penetrated, a continuous fluid flow path is established through the aseptic connector  100  between the flexible container  301  and the flexible tubing  205 . The continuous fluid flow path permits aseptic evacuation of the contents of the flexible container  301  through the aseptic connector  100  and flexible tubing  205  to another location. According to exemplary embodiments, the aseptic connector  100  provides for aseptic fill and evacuation at pressures of up to 125 psi (8.6 bar), and temperatures of between −40° F. (−40° C.) and 280° F. (138° C.), although greater pressures and temperatures are possible. 
         [0032]    After the transfer is completed, the conduit portion  105  is retracted. The pivot portion  103  is rotated another step to the closed position, which is the final position of the aseptic connector  100 . To assure sterility, once moved to the closed position, the pivot portion  103  cannot be returned to the active position. That is, it is locked in place and an operator cannot move the pivot portion  103  relative to the body portion  101 . 
         [0033]    At this point, the aseptic connector  100  can be detached from the fill connector  212  (typically by unscrewing when using the preferred threaded connection). The aseptic connector  100 , or at least that portion of it including the conduit portion  105 , having been transitioned to its closed position prior to removing the fill connector  212 , remains sterile. While the fill connector side (i.e. the female receptacle of the base portion) is considered jeopardized by exposure to the environment following removal from the body portion  101 , the closed position seals that exposure from the interior of the aseptic connector  100 , including the conduit portion  105 . Furthermore, the contents of the flexible container  301  are presumably evacuated to the extent desired (preferably until empty in most instances) and the sterility of the disconnected fill connector  212  itself at that point is also of little concern. 
         [0034]    Referring to  FIG. 4 , a method of operating the aseptic connector  100  includes, aligning the fill connector  212  of the flexible (or other style of) container housing liquid contents to be aseptically evacuated with the receptacle  210  of the aseptic connector body portion  101  (step  401 ). The aligning of the fill connector  212  with the receptacle  210  is performed with the aseptic connector  100  staged in the ready position. The fill connector  212  is then fully secured to the receptacle  210  of the aseptic connector  100  (step  403 ). As illustrated in  FIG. 4 , the connector  212  is screwed onto the receptacle  210 , although any other securing mechanism may be used. After securing the fill connector  212  to the receptacle  210 , the fill connector cap  216  is seated within the recess in the pivot portion  103  of the aseptic connector  100 . 
         [0035]    Next, the pivot portion  103  is rotated into the active position (step  405 ), breaking off the fill connector cap  216 . As illustrated, the body portion  101  includes a side opening that allows the cap  216  to be ejected (step  407 ) from the aseptic connector  100  after being broken off of the fill connector  212 . After rotating the pivot portion  103  into the active position, the conduit portion  105  is axially slid into the fill connector  212  in the receptacle  210  (step  409 ), piercing any septum in the fill connector  212 , and establishing fluid communication through the aseptic connector  100  to evacuate the contents of the flexible container  301 . 
         [0036]    After evacuation is complete, the conduit portion  105  is retracted from the fill connector  212  (step  411 ) and the pivot portion  103  is rotated another increment to a closed position (step  413 ), closing the flow path on the conduit portion side, and permitting the subsequent removal of the now-evacuated flexible container  301  for disposal, while retaining the aseptic flowpath from the aseptic connector  100  to the flowpath&#39;s terminus. 
         [0037]    As a result, the aseptic connector  100  of the invention, when used in conjunction with a sterile fill system such as the one described, provides a system that allows fill and evacuation aseptically through the same port of a flexible container  301 . In a preferred embodiment, the aseptic connector meets compliance specifications for one or more of the following: ISO 10993, NAO, Cytotoxity, and is BPA, DEHP, Latex and/or Melamine free. Furthermore, in a preferred embodiment, the aseptic connector is capable of meeting some or all of the following tests, the procedures for which are known to those of ordinary skill in the art: Bacterial Challenge, Microbial Ingress Test, Steam Leak Test, Helium Leak Test, Burst Test, Flow Test, Tensile Test, Creep-Rupture Test, Biocompatibility Tests, Functional Testing after Accelerated Aging, Bubble Leak Test, Endotoxin Test, Bioburden Test, and Total Organic Compounds (TOC). 
         [0038]    Alternative embodiments are shown in  FIGS. 5 and 6 , which illustrate other mechanical arrangements that demonstrate an aseptic connector  100  having one-directional advancement from ready to active to closed positions.  FIG. 5  illustrates a dial type connector  501 , while  FIG. 6  illustrates a sliding type connector  601 . While the manner in which relative movement of the body portion  101  with respect to the pivot portion  103  is different, the effect is the same as described previously, with the receptacle  210  receiving the fill connector  212 , moving the pivot portion  103  with respect to the body portion  101  to align the conduit portion  105  and/or spike and pierce the septum  218  (see  FIGS. 3-4 ) to permit fluid flow, followed by again moving the pivot portion  103  with respect to the body portion  101  to close the fluid flow path to permit separation of the container  301  without loss of sterility to the opposite end of the flow path. It will be appreciated that other mechanical arrangements are also contemplated that fall within the concept of the invention of providing an aseptic connector that mates with a fill connector of a container and thus permits sterile filling and evacuation of the container by the same port. 
         [0039]    It will be appreciated that the references to fill connector and aseptic connector as used herein is primarily for purposes of differentiating mechanical parts and while named with respect to the convention of a preferred embodiment, is not intended as a limitation on use or to define the direction in which fluid necessarily flows. 
         [0040]    While the invention has been described with reference to a preferred embodiment, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiment disclosed as the best mode contemplated for carrying out this invention, but that the invention will include all embodiments falling within the scope of the appended claims.