Abstract:
A connector ( 10 ) is provided for sterile connection to a complementary connector ( 12 ). The connector ( 10 ) has a housing ( 14 ) with an engagement device ( 16 ) to engage a complementary engagement device ( 18 ) of the complementary connector ( 12 ) along an engagement direction ( 44 ). The connector ( 10 ) is displaceable relative to the complementary connector ( 12 ) along the engagement direction ( 44 ) after the engagement device ( 16 ) engages the complementary engagement device ( 18 ). The housing ( 14 ) has a feed-through opening ( 24 ) for receiving a sensor ( 34 ) and a cover ( 22 ). The cover ( 22 ) is displaced relative to the connector ( 10 ) along the engagement direction ( 44 ) to close the feed-through opening ( 24 ) in a sterile manner. The connector ( 10 ) also has a sterile sensor ( 34 ) that is movable along a sensor displacement direction ( 52 ) that differs from the engagement direction ( 44 ).

Description:
BACKGROUND OF THE INVENTION 
       [0001]    1. Field of the Invention. 
         [0002]    The present invention relates to a connector for sterile connection to a complementary connector, to a connector system for sterile connection of a feed-through opening of a connector to a fluid inlet and/or fluid outlet of a conventional connector, and to the use of a connector and of a complementary connector for sterile connection of a feed-through opening of the connector to a fluid inlet and/or fluid outlet of the complementary connector. 
         [0003]    2. Description of the Related Art. 
         [0004]    In modern pharmaceutical technology and/or laboratory technology, use is frequently made of containers, such as, for example, bags, flexible tubes bioreactors, etc., in which bioprocesses, and chemical, biochemical, etc. reactions take place. In particular, these reactions take place in a closed environment, i.e. without connection to a surrounding medium. It is necessary in this case to avoid germs from the environment penetrating the interior of above-mentioned containers and impairing and distorting the progress of reactions, experiments, etc. Furthermore, containers of this type may be used in hospital environments, for example for blood transfusion and blood washing. In this case too, care has to be taken to ensure that germs from the environment do not penetrate the interior of a container, since, for example, the content of the container could be contaminated as a result. 
         [0005]    Many of the processes taking place in these preferably flexible containers should, if possible, take place under predetermined or controlled conditions. For this purpose, it may be necessary, for example, to detect and/or to measure physical variables or values of the media present in the containers. For example, it may be necessary to measure variables, such as temperature, pH value, cell density, optical transmission, etc., wherein these values are to be measured as directly as possible without running the risk of contaminating the interior of the container. 
         [0006]    It is therefore an object to determine physical and/or chemical and/or other parameters in the interior of a container in a simple manner without the interior of the container entering into contact with a surrounding medium. 
       SUMMARY OF THE INVENTION 
       [0007]    According to one aspect of the invention, a connector for sterile connection to a complementary connector comprises a connector housing with an engagement device that is designed to enter into engagement with a complementary engagement device of the complementary connector essentially along an engagement direction. The connector is displaceable relative to the complementary connector essentially along the engagement direction after the engagement device enters into engagement with the complementary engagement device. The connector further includes a feed-through opening for feeding a sensor device therethrough. A displaceable, sterile covering device is designed to close the feed-through opening in an essentially sterile manner. The covering device is displaced relative to the connector essentially along the engagement direction when the connector is displaced relative to the complementary connector. The connector further includes an essentially sterile sensor device that is movable essentially along a sensor displacement direction. The engagement direction differs from the sensor displacement direction. 
         [0008]    For example, the sensor device can be essentially cylindrical, and the sensor displacement direction can be essentially parallel to an axis of symmetry of the sensor device, in particular a cylinder axis of the sensor device. The engagement direction can preferably be essentially perpendicular with respect to the sensor displacement direction. 
         [0009]    The term “essentially cylindrical” within the meaning of the invention comprises, for example, production-induced deviations from the cylindrical shape. In particular, the sensor device may not have a circular shape in cross section with a constant radius, but rather, as expressed in cylindrical coordinates, different radii given different solid angles. In particular, given different solid angles, the actual radius may differ from the radius of the circular shape by approximately 20%, in particular by approximately 10% or less. 
         [0010]    The term “displaceable essentially along the engagement direction” within the meaning of the invention comprises the fact that, for example, the connector and the complementary connector are displaceable precisely along the engagement direction. However, during the displacement, there may be a deviation from the engagement direction. For example, the connector may be displaced relative to the complementary connector along a direction which differs from the engagement direction, for example is at an angle of about 1° to about 20°, preferably about 3° to about 10° with respect to the engagement direction. The direction at which the connector is displaceable relative to the complementary connector may also be askew with respect to the engagement direction. 
         [0011]    If the sensor device is pushed or moved along the sensor displacement direction through the feed-through opening, the sensor device can enter into engagement with the complementary connector, in particular a fluid inlet and/or fluid outlet, as a result of which further displacement of the connector relative to the complementary connector along the engagement direction is prevented. The sensor device is therefore advantageously also a locking device. 
         [0012]    The connector preferably is designed such that, when the sterile covering device is displaced, a sterile, complementary covering device of the complementary connector is also displaceable. Consequently, sterile regions of the connector only enter into contact with sterile regions of the complementary connector, i.e. the connection between the connector and the complementary connector is essentially sterile. 
         [0013]    In this invention, the term “sterile” is used according to its conventional use, i.e. the term “sterile” covers, in particular, germ-free or sterilized or infertile. However, germ-free does not have to mean a complete absence of germs or foreign bodies. On the contrary, germ-free may contain a predetermined or predeterminable maximum number of germs or foreign bodies. For example, sterile may cover a maximum number of germs as permitted or desired in accordance with conventional industrial standards. 
         [0014]    After the sterile connection between the connector and the complementary connector is produced, the sensor device can be at least partially introduced along the sensor displacement direction through the feed-through opening into the complementary connector. The sensor device can therefore enter into contact with an interior of the complementary connector or with an interior of an object to which the complementary connector is connected. For example, the complementary connector may be connected directly to a container. In other words, the fluid inlet and/or fluid outlet of the connector is connected directly to the container preferably in a sterile manner. The sensor can therefore be at least partially inserted into the interior of the complementary connector and/or into the interior of the container connected to the complementary connector. In particular, the sensor device can come into connection or contact with a medium in the container, for example a fluid, a liquid, a gas, etc. The sensor device can therefore advantageously directly measure or detect or determine physical properties of the fluid, the liquid, the gas, etc. 
         [0015]    The container is preferably a bioreactor, a bag or a filter housing, particularly preferably a “filter capsule”. 
         [0016]    The sensor device may be, for example, an electric, an electronic, a mechanical, an optical, a chemical, etc., sensor device. The sensor device may be connected to an analyzing device by means of a cable, for example an electric cable, a glass fiber cable, etc. However, the sensor device may also be connected to an analyzing device without a cable. In this case, the analyzing device may be arranged outside the connector. However, the analyzing device may also be part of the sensor device, and the sensor device or the analyzing device may furthermore be equipped with a display device, in particular a digital display device, for example for displaying a temperature. 
         [0017]    The sensor device may be movable, for example, manually and/or automatically along the sensor displacement direction. For example, a higher pressure may be present in the interior of the connector than in the interior of the complementary connector or of the container connected thereto. If the connector and the complementary connector are connected to each other in a fluidtight manner, the sensor device can be at least partially pushed or moved into the interior of the complementary connector or of the container connected thereto, for example, by equalization of the pressure. Alternatively, the pressure in the container can be increased and, as a result, the sensor device can be moved out of the container or the complementary connector again and back into the connector. 
         [0018]    By means of the engagement device, the connector is fixable to the complementary connector essentially along the sensor displacement direction. Fixable along a predetermined direction within the meaning of this invention means, for example, that, during normal operating forces, a movement of the connector relative to the complementary connector in the predetermined direction is completely suppressed, or only a very limited movement in the predetermined direction is possible. The term “locking” or “lockable” is used essentially synonymously. 
         [0019]    On account of the engagement device, the connector is therefore fixable or lockable to the complementary connector essentially along the sensor displacement direction. Furthermore, on account of the at least partial insertion of the sensor device into the complementary connector or the container arranged thereon, the connector is fixable or lockable to the complementary connector essentially along the engagement direction. 
         [0020]    The connector is particularly preferably releasably fixable or lockable to the complementary connector. 
         [0021]    Furthermore, the connection between the connector and the complementary connector is preferably fluidtight, i.e. an exchange of fluids or a communication of fluids with the environment is essentially not possible. However, an exchange of fluids between the connector and the complementary connector is possible. In particular, after the sensor device is removed from the complementary connector or from the container arranged thereon, the connector is displaceable relative to the complementary connector along or counter to the engagement direction, as a result of which the connector can be separated from the complementary connector. 
         [0022]    The sensor device is preferably arranged within a sensor chamber which has an essentially sterile interior. In particular, the sensor chamber contains the feed-through opening. Particularly preferably, the connector has an interior space, and the interior space is essentially identical to the sensor chamber. 
         [0023]    Furthermore, the connector housing is preferably at least partially composed of a flexible material, and the connector housing is furthermore designed in such a manner that the volume of the sensor chamber can be varied. In particular, the size of the sensor chamber can be matched to the size of the sensor device. 
         [0024]    The connector housing preferably is designed to be at least partially compressible and/or extendable, in particular the connector housing is designed such that it is expandable. The connector housing can therefore advantageously be matched to the size of the sensor device in a simple manner. For example, the connector housing can be at least partially squeezed manually and, in particular, force can be transmitted from the outside to the sensor device, as a result of which the sensor device can be movable manually or automatically into the interior of the complementary connector or of the container arranged thereon. In other words, the interior volume of the connector housing and of the sensor chamber are matchable, as a result of which an at least partial removal of the sensor device from the sensor chamber or the connector chamber can be compensated for. 
         [0025]    The connector housing preferably is at least partially composed of a material capable of being reset. The connector housing may be manufactured, in particular, from different materials, for example from rigid and flexible materials. The connector housing may be composed, for example, at least partially of a rigid plastic and at least partially of a flexible material capable of being reset, such as, for example, a film, a rubber, a soft polymer, etc. 
         [0026]    The connector is preferably designed, after arrangement or connection of the connector with or to the complementary connector, to connect the sensor chamber to an interior space of the complementary connector in an essentially sterile manner. In other words, a sterile connection of the interior space of the connector to the interior space of the complementary connector and the container arranged thereon can be produced without impurities or germs from the environment being able to penetrate the interior space of the complementary connector or of the container arranged thereon. 
         [0027]    Furthermore, the connector housing is preferably designed to exert a force on the sensor device. For example, owing to the capability of the material of the connector housing to be reset, the connector housing may be prestressed. For example, the connector housing may be stretched and, on account of its capability of being reset, may endeavor to attain an unstretched state. In this case, a force can be transmitted to the sensor device. Particularly preferably, the sensor device can be pressed, for example, against the sterile covering device. If the sterile covering device is removed, then, owing to the force applied by the connector housing, the sensor device can be displaced or moved essentially along the sensor displacement direction. In an advantageous manner, when the connector is connected to the complementary connector, in the process the sensor device can automatically be at least partially pushed into the interior of the complementary connector or of the container arranged thereon, and the connector can be automatically locked at the same time to the complementary connector along the engagement direction. 
         [0028]    The connector housing is therefore advantageously designed, after connection of the connector to the complementary connector, to move the sensor device at least partially into the complementary connector. 
         [0029]    Particularly preferably, after removal of the covering device and of the complementary covering device, the sensor device is movable through the opening device into the interior space of the complementary connector. 
         [0030]    A further aspect of the present invention comprises a connector system for sterile connection of a feed-through opening of a connector according to the present invention to a fluid inlet and/or fluid outlet of a conventional connector. The feed-through opening of the connector and the fluid inlet and/or fluid outlet of the conventional connector are preferably connected to each other in a fluidtight manner. 
         [0031]    A further aspect of the invention relates to the use of a connector and of a complementary connector for sterile connection of a feed-through opening of the connector to a fluid inlet and/or fluid outlet of the complementary connector. The use preferably is carried out by providing the connector and the complementary connector; bringing an engagement device of the connector into engagement with a complementary engagement device of the complementary connector; displacing the connector relative to the complementary connector along an engagement direction and displacing the sensor device along a sensor displacement direction. 
         [0032]    The connection of the feed-through opening of the connector to the fluid inlet and/or fluid outlet of the complementary connector is preferably fluidtight. 
         [0033]    Furthermore, the sensor device is preferably pushed along the sensor displacement direction through the feed-through opening and at least partially into the fluid inlet and/or fluid outlet of the complementary connector. 
         [0034]    The covering device of the connector and/or the complementary covering device of the complementary connector preferably are displaced along the engagement direction when the connector is displaced relative to the complementary connector. 
         [0035]    Furthermore, the sensor device preferably is removed again from the complementary connector. 
         [0036]    The connector preferably is separated from the complementary connector, and the connector, by means of the covering device, and/or the complementary connector, by means of the complementary covering device, is closed again in a fluidtight, furthermore preferably sterile, manner. 
         [0037]    Furthermore, the above details concerning the connector or the complementary connector apply analogously also to the preferred use thereof according to the invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0038]      FIG. 1  shows a schematic sectional view of a preferred connector and of a complementary connector. 
           [0039]      FIG. 2  shows a schematic sectional view of a preferred connector and of a complementary connector according to  FIG. 1 , but rotated through 90°. 
           [0040]      FIG. 3  shows a schematic sectional view according to  FIG. 2 . 
           [0041]      FIG. 4  shows a schematic sectional view according to  FIG. 2 . 
           [0042]      FIG. 5  shows a schematic sectional view according to  FIG. 2 . 
           [0043]      FIG. 6  shows a schematic sectional view according to  FIG. 2 . 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0044]      FIG. 1  shows a connector  10  and a complementary connector  12 . The connector  10  has a connector housing  14 . The connector housing  14  includes a projection  16 . The projection  16  at the same time constitutes the engagement device  16 . The engagement device  16  can enter into engagement (not illustrated) with a complementary engagement device  18  of a complementary connector housing  20  of the complementary connector  12 . Furthermore, a germ barrier in the form of a sterile covering  22  is arranged on the connector housing  14 . The sterile covering  22  can be designed, for example, as a slide. The sterile covering  22  covers, in particular, a feed-through opening  24  of an interior space  26  of the connector housing  14  of the connector  10 . Furthermore, a sealing means  28  is arranged in the form of an O-ring  28 . The O-ring  28  permits a fluidtight connection of the connector housing  14  to the sterile covering  22  when the engagement device  16  and the complementary engagement device  18  are in engagement. 
         [0045]    Analogously, the complementary connector  12  has a complementary, sterile covering  30  in the form of a slide. Similarly, the complementary connector housing  20  of the complementary connector  12  has a sealing means  32  in the form of an O-ring  32 . The O-ring  32  permits a fluidtight and sterile connection between the sterile covering  30  and the complementary connector housing  20  of the complementary connector  12 . The O-rings  28 ,  32  may be essentially the same size. The O-rings  28 ,  32  may also differ in size. Consequently, in the use position of the connector  10  and of the complementary connector  12  (shown in  FIGS. 5 and 6 ), the O-ring  28  and the O-ring  32  can rest on each other or can each make contact with an opposite surface of the complementary connector  12  or of the connector  10 . 
         [0046]      FIG. 2  shows a schematic sectional view of the connector  10  and of the complementary connector  12 , rotated through  900  in relation to the view of  FIG. 1 . Furthermore,  FIG. 2  shows a sensor  34 , which is not shown in  FIG. 1 . The sensor  34  may be, for example, a pressure, temperature or pH value sensor, etc. The sensor  34  may be designed, in particular, in order to detect or to provide conventional or particularly necessary measured values. Furthermore, a protective film  36  is illustrated in  FIG. 2 . The protective film  36  covers the sterile covering  22  and a partial region of the connector housing  14  or of the engagement device  16 . The engagement device  16  is not illustrated in  FIG. 2 . 
         [0047]    The protective film  36  can shield, for example, sections of the connector  10  or of the complementary connector  12  that are covered or overlaid by it in a sterile manner in relation to the environment. Additionally or alternatively, the protective film may be designed to protect sections of the connector  10  or of the complementary connector  12  that are covered or overlaid by it against mechanical influences, for example against impacts, etc. The protective film  36  may also be designed in order to fix components of the connector  10 , for example the sterile covering  22 , or to fix components of the complementary connector  12 , for example the complementary, sterile covering  30 . The protective film  36  may also be designed to arrange the sterile covering  22  on the connector housing  14  of the connector  10  or to arrange the complementary, sterile covering  30  on the complementary connector housing  20  of the complementary connector  12 . 
         [0048]    Furthermore,  FIG. 2  illustrates a sensor chamber  38  as part of the connector housing  14 . The sensor chamber  38  is designed in a partial region as an expansion bellows  40 . The expansion bellows  40  permits the sensor chamber  38  to be able to be varied in its size. Furthermore, the sensor has a cable connection  42  to a peripheral device (not shown). The cable connection  42  may be a conventional signal line. However, instead of the cable connection  42 , a cable-free transmission of data of the sensor  34  to a peripheral device (not shown) may also take place. Alternatively, the sensor  34  may also be equipped with an analyzing device and/or a display device, which can illustrate measured values detected by means of the sensor  34 . For this purpose, the sensor  34  is advantageously at least partially designed to be essentially transparent. Similarly, the connector housing  14  can be at least partially transparent. 
         [0049]    The covering device  22  is preferably arranged in such a manner that there is a fluidtight and a sterile connection of the covering device  22  to the connector housing  14  by means of the O-ring  28 . Analogously, the complementary covering device  30  is arranged so that there is a fluidtight and a sterile connection of the complementary covering device  30  to the complementary connector housing  20  by means of the O-ring  32 . 
         [0050]    Furthermore,  FIG. 2  illustrates the complementary connector  12 , as described in  FIG. 1 . 
         [0051]      FIG. 3  shows the connector  10  and the complementary connector  12 , as illustrated in  FIG. 2 , but with the protective films  36  having been removed. 
         [0052]      FIG. 4  shows the connector  10  and the complementary connector  12 , with the connector  10  and the complementary connector  12  being arranged in such manner that the engagement device  16  (not shown) and the complementary engagement device  18  (not shown) are entered into engagement. The connector  10  can be displaced relative to the complementary connector  12  along the engagement direction  44 . If the connector  10  is displaced relative to the complementary connector  12 , the sterile covering  22  strikes against a projection  46  of the complementary connector  12 . During the movement of the connector  10  relative to the complementary connector  12  along the engagement direction  44 , the sterile covering  22  remains essentially fixed in position relative to the complementary connector  12 . Analogously, the sterile covering  30  of the complementary connector  12  strikes against a projection  48  of the connector housing  14  of the connector  10 . During the movement of the connector  10  relative to the complementary connector  12  along the engagement direction  44 , the sterile covering  30  remains essentially fixed in position relative to the connector  10 , i.e. the sterile covering  30  is displaced relative to the complementary connector  12  along the engagement direction  44 . 
         [0053]      FIG. 5  shows the connector  10  and the complementary connector  12  in a use position which permits the sensor  34  to be at least partially inserted through the feed-through opening  24  into the interior of the complementary connector  12 . The sensor  34  is preferably displaced essentially along a sensor displacement direction  52  through an inlet opening  50  and/or an outlet opening  50  of the complementary connector. The sensor displacement direction, as illustrated in  FIG. 5 , is essentially parallel to a cylinder axis (not shown) of the essentially cylindrical sensor  34 . In particular, the sensor displacement direction  52  is essentially perpendicular with respect to the engagement direction  44 , as illustrated in  FIG. 4 . 
         [0054]    Furthermore, the O-ring  28  and the O-ring  32  serve to provide a fluidtight connection between the feed-through opening  24  and the inlet opening/outlet opening  50 . A sterile connection of the connector  10  to the complementary connector  12  can be provided by means of the two O-rings  28 ,  32  by the O-ring  28  entering into contact with a surface of the complementary connector  12 , which surface lies opposite it. Analogously, the O-ring  32  can enter into contact with a surface of the connector  10 , which surface lies opposite it. Alternatively, the O-ring  28  can also enter into contact with the O-ring  32 . 
         [0055]    The sensor  34  can be moved, in particular pressed, for example manually, into the interior of the complementary connector  12  and of the container (not shown) arranged thereon. The sensor chamber can be prestressed, for example, along the sensor displacement direction  52 . For this purpose, a spring (not shown) can be arranged in or on the sensor chamber  38 . In this case, the sensor  34  is advantageously moved automatically in the direction of the complementary connector  12  as soon as the connector  10  and the complementary connector  12  are in the use position. It is therefore advantageously just avoided that the connector  12  is displaced along the engagement direction  44  to such an extent that the sensor  34  can no longer be pushed into the interior of the complementary connector  12 . In other words, the sensor  34  can also serve as an automatic locking device of the connector  10  and of the complementary connector  12  along the engagement direction  44 . 
         [0056]      FIG. 6  shows the connector  10  and the complementary connector  12  according to the use position illustrated in  FIG. 5 , with the sensor  34 , in comparison to the illustration of  FIG. 5 , having been pushed or moved along the sensor displacement direction  52  and the sensor  34  at least partially protruding into the interior of the complementary connector  12  or of the container (not shown) arranged thereon. 
         [0057]    The invention is not restricted only to the above-described exemplary embodiments. On the contrary, the invention may differ from these exemplary embodiments. For example, one or more sealing means may be arranged in the sensor chamber, as a result of which a sensor chamber wall locks to the sensor in a fluidtight manner. When the connector  10  is connected to the complementary connector  12 , fluid which is located, for example, in a container cannot penetrate completely into the sensor chamber but rather merely as far as the additional O-ring. In this connection, the movement of the sensor  34  along or counter to the sensor displacement direction  52  is essentially not restricted. Similarly, a sealing means can be arranged on an inner wall of the inlet opening/outlet opening  50  of the complementary connector  12  and locks to the sensor  34  in a fluidtight manner as soon as the sensor  34  is pushed through the inlet opening/outlet opening  50 . An outlet of fluid from the container can therefore also essentially be prevented as a result. 
         [0058]    Similarly, the sensor  34  may have a different shape. The sensor  34  may be, for example, angled or round. The sensor  34  may furthermore be composed, for example, just of one or more wires, if appropriate in conjunction with one or more resistors. 
         [0059]    Furthermore, the connector  10  can also be designed in such a manner that a fluid can flow through it. In other words, in addition to the feed-through opening  24 , the connector  10  may have a further opening  54 . Fluid can pass from the complementary connector  12  or the container arranged thereon into the connector  10 , can flow through the connector  10  and can leave the connector  10  again through the opening  54 . In particular, the opening  54  can be closed in a sterile manner by means of a covering device (not shown) or can be connected, in particular in a sterile manner, to a further device (not shown), for example a flexible tube (not shown), a container (not shown), etc. Therefore, in an advantageous manner, for example during transportation of fluid between two containers, one or more parameters of the fluid can be detected or measured by means of the sensor  34 . In this case, for example, the sensor  34  can enter into contact with the fluid or the fluid can flow around it. 
         [0060]    Furthermore, the complementary connector  12  can be an integral part of a container, and the complementary connector  12  can be, in particular, a conventional complementary connector. In other words, the connector  10  is designed in such a manner that it can be connected to a conventional connector in a fluidtight manner, and the sensor can penetrate through an opening of the conventional, complementary connector into the interior of the complementary connector or of the container arranged thereon. 
         [0061]    Instead of the connector  10 , for example, a differently designed connector  10  can be connected to the complementary connector, the differently designed connector making it possible, for example, to let a fluid out of a container. In other words, if necessary, the connector  10  according to the invention can be exchanged for a conventional connector, for example in order to close just the complementary connector  12  and/or in order to produce a fluidic connection to a further container. 
         [0062]    Furthermore, the connector  10  can be designed in such a manner that the sensor  34  can be changed in a simple manner without the interior space  26  of the connector  10  being contaminable or rendered impure by germs or impurities from the environment. For example, the connector housing  14  may have a coupling piece and/or adapter piece, using which the sensor  34  can be changed in a simple manner.