Abstract:
A fluid flow control device adapted to control the flow of fluid from a fluid container to a fluid extraction device without the need for a needle. The fluid flow control device includes a connector element and a container insert member which define a fluid channel. A compressible valve element is disposed in the fluid channel of the connector element and the container insert member. The valve element includes a plug and shaft and resiliently prevents the flow of fluid by forming a fluid seal in the fluid channel. The valve element may be operationally engaged by the fluid extraction device thereby breaking the fluid seal and allowing the fluid to flow from the container to the fluid extraction device.

Description:
FIELD OF THE INVENTION  
         [0001]    The present invention relates to flow control and more particularly, to the control of fluid flow from containers of medical solutions through valves, access parts, and other connectors.  
         BACKGROUND OF THE INVENTION  
         [0002]    When it is contemplated that a patient will require the administration of fluid medicament, a medicament delivery apparatus, such as a syringe having a needle, and a medicament container are commonly required. Currently, most medicament containers are typically a fluid vial or container that is sealed with a rubber elastomer or septum. To access the contents of the container or vial, the rubber elastomer or septum must be pierced with a needle or similarly sharp instrument. Once the elastomer or septum is pierced, the contents of the container or vial can be accessed for administration to the patient. However, there are several drawback to using this type of container or vial.  
           [0003]    First, using a container or vial that requires the use of a needle or sharp instrument for access to the contents of the container/vial creates a hazardous working environment for a healthcare worker. Not only is the healthcare worker exposed to possible bodily injury via an accidental needle stick, but once the needle has been used to administer the fluid or medicament to the patient, the needle is also considered a high risk article. Thus, the healthcare worker may also be exposed to potential diseases and other life threatening diseases from the high risk needle.  
           [0004]    Second, once the septum or elastomer is pierced, the medicament in the container or vial may leak since these containers or vials are not completely resealable. Also, there is a possibility that bacteria may develop in and around the pierced septum, tainting the remaining contents of the container or vial. This reduces the desirability of using the container or vial as a multiple dose container.  
           [0005]    Third, the container or vial can be particularly difficult to manipulate to access the entire contents of the container, especially in situations where there is only a small amount of medicament or fluid left in the container or vial.  
           [0006]    Fourth, the container or vial is not compatible with some fluid delivery systems. Currently, there are needleless fluid delivery systems that allow access to the patient&#39;s vascular system via the connector of an intravenous tubing set. For example, U.S. Pat. No. 5,782,816 to Werschmidt et. al., the entire contents of which is incorporated herein by reference, discloses a bi-directional valve that allows access to a connector without the need for a needle. Transferring the contents from the container or vial to the needleless system would be difficult since the needleless system uses a connector that is not designed to be accessed by a needle, while the container or vial requires a needle to access its contents. Accordingly, to transfer the contents from the container or vial to a needleless system, a user must first access the contents with a needle, transfer the contents to a second instrument that does not have a needle, and, via the second instrument, transfer the contents to the needless system.  
           [0007]    Therefore, there exists a need for a container or vial that does not require a needle to access its contents. There also exists a need for a container or vial that is resealable. There further exists a need for a container or vial that is easy to manipulate to allow quick and easy access to its contents. There also exists a need for a container that is compatible for use with a needleless system. There further exists a need for a container or vial that easily allows access to its entire contents.  
         SUMMARY OF THE INVENTION  
         [0008]    The present invention relates to a fluid control device for use with a fluid container. The device allows for needleless access of the contents stored in the fluid container and is compatible for use with other needleless systems. The device also is resealable and is easily manipulable to allow quick and easy access to substantially the entire contents of the container. Furthermore, the device provides a swabable surface to allow for easy cleaning and decontamination.  
           [0009]    In one embodiment, the fluid flow control device includes a container insert member, a connector element defining a valve seat coupled to the container insert member, and a resilient valve element disposed in the container insert element and the connector element, and being movable from a first position to a second position. The valve element, in its first position, forms a seal with the valve seat. The valve element, in its second position, is canted, bent, buckled, bowed, or moved from the valve seat to create a fluid channel.  
           [0010]    The container insert member can have a hollow interior defining an opening extending from a proximal surface of the container insert member to the interior of the container insert member where at least one window extends from an outer surface of the container insert member to the interior of the member and extends along the container insert member from the distal end to the proximal end of the container insert member. The container insert member may also have a flange located near the proximal end of the container insert member for abutting a lip surrounding a fluid container opening.  
           [0011]    The connector element has an axial throughbore, a portion of which forms a valve seat, extending from the proximal end to the distal end of the connector element and further includes a collar located at the distal end of the connector element for coupling to the proximal end of the container insert member. The connector element may be configured for coupling with a fluid extraction device near its proximal end. For example, the fluid extraction device may have a male Luer fitting for coupling to the proximal end of the connector element. The coupling of the male Luer fitting to the proximal end of the connector element moves the valve element from the first position to the second position, thereby forming a fluid channel between the fluid container and the male Luer fitting of the fluid extraction device.  
           [0012]    The valve element includes a plug disposed near the proximal end of the connector element, and a shaft formed at the distal end of the plug and extending to the distal end of the container insert member. The distal end of the valve element abuts and rests on the distal end of the interior surface of the container insert member. The plug and the shaft of the valve element may have at least one buckling section with characteristics for being axially compressible to move the valve element from the first position to the second position.  
           [0013]    The fluid control device may also include a container wrapper member configured and dimensioned to assist in coupling the flange of the container insert member to the container. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0014]    To facilitate an understanding of and for the purpose of illustrating the present invention, exemplary and preferred features and embodiments are disclosed in the accompanying drawings, it being understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown, and wherein similar reference characters denote similar elements throughout the several views, and wherein:  
         [0015]    [0015]FIG. 1 is an exploded view of a fluid flow control device with a fluid container according to the principles of the present invention;  
         [0016]    [0016]FIG. 2 is a perspective view of the device of FIG. 1 assembled;  
         [0017]    [0017]FIG. 3 is a perspective view of a connector element of the fluid flow control device of FIG. 1;  
         [0018]    [0018]FIG. 4 is a bottom view of the connector element of FIG. 3;  
         [0019]    [0019]FIG. 5 is a perspective view of a container insert element of the fluid flow control device of FIG. 1;  
         [0020]    [0020]FIG. 6 is a side cross-sectional view of an exemplary fluid flow control device in accordance with the principles of the present invention with the fluid container of FIG. 1 in a closed state;  
         [0021]    [0021]FIG. 7 is a side cross-sectional view of the fluid flow control device of FIG. 7 activated by a male Luer fitting to an open state; and  
         [0022]    [0022]FIG. 8 is a perspective view of a container wrapper member of the fluid flow control device of FIG. 1. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0023]    Referring to the accompanying drawings, preferred embodiments and features of the fluid flow control device for a fluid container will be described in detail. It is to be noted however that these descriptions of specific embodiments and features are merely illustrative. It is contemplated that one or more features or elements of the various embodiments may be combined or used singularly, and that modifications of the various embodiments, as well as other embodiments, are contemplated and will be apparent to those persons skilled in the art.  
         [0024]    Referring initially to FIG. 1, an exploded view of an exemplary embodiment of fluid control device  10  is shown. Control device  10  preferably has a connector element  12  having proximal end  14 , distal end  16 , and longitudinal axis  18 . In the embodiments of FIGS. 1, 2,  3 , and  4 , connector element  12  has a generally circular-cylindrical shape with an axial throughbore  20 , which extends along axis  18  from proximal end  14  to distal end  16 . Proximal portion  19  of connector element  12  is configured and dimensioned to interface with a fitting, preferably needleless, such as a male Luer fitting, from a fluid extraction device, such as a syringe or intravenous tubing. Although shown as circular-cylindrical, connector element  12  may be any shape that allows connection to a fluid extraction device and to the container insert member. For example, connector element  12  may be hexagonally-cylindrical or octagonally-cylindrical. In an exemplary embodiment, proximal portion  19  of connector element  12  may also include threading  22  on an exterior surface for threadably engaging the fitting of the fluid extraction device. Threading  22  allows the fitting to engage connector element  12  securely, thereby preventing accidental disconnection or fluid leakage. Distal portion  21  of connector element  12  may have an enlarged diameter section, or collar  24 , for facilitating coupling of connector element  12  to a container insert member, discussed below. In the embodiment illustrated, the portion of axial throughbore  20  located in distal portion  21  has a larger diameter than the portion of axial throughbore  20  located in proximal portion  19 .  
         [0025]    Turning to FIG. 4, a bottom view of connector element  12  is shown. In an exemplary embodiment, a portion of axial bore  20  forms valve seat  26 . Valve seat  26  is sized to receive a portion of a valve element (element  46  discussed below) in sealing engagement to form a primary fluid seal. Preferably, valve seat  26  includes at least one sealing surface  27 , which is a transitionary surface in which axial bore  20  increases in diameter from the smaller diameter section located in proximal portion  19  to the larger diameter section located in collar  24  in distal portion  21 . Although valve seat  26  is shown to be located near the proximal end of collar  24  of connector element  12 , valve seat  26  may be located any place along axial bore  20 .  
         [0026]    Referring back to FIG. 1, control device  10  also preferably includes a container insert member  28 . Container insert member  28  has a proximal end  30 , a distal end  32 , and a longitudinal axis  34 . Proximal portion  35  is configured and sized to interface and to couple with connector element  12  and distal portion  37  is configured and sized to fit within fluid container  41  via opening  39 . Fluid container  41  may be any container capable of storing fluid, such as medicament, and having at least one opening or access point through which the contents inside the container may be accessed.  
         [0027]    As can be seen in FIGS. 1 and 5, at proximal end  30 , container insert member  28  has opening  36  which leads to hollow interior  38 . In an exemplary embodiment, surrounding opening  36  is collar  40 . Collar  40  may be configured and dimensioned to be coupled within collar  24  on connector element  12  and thereby to be coupled to fluid container  41 . Preferably, the outer diameter of collar  40  is substantially equal to the inner diameter of axial throughbore  20  at distal portion  21  of connector element  12 , allowing collar  40  to be received in and coupled to collar  24 . Collar  24  and collar  40 , and thus connector element  12  and container insert member  28 , may be coupled together in a number of ways including, without limitation, bonding agents, ultrasonic welding, interference fitting, and tongue and groove fittings. Preferably, this coupling prevents leakage of any fluid. When coupled together, axial bore  20  of connector element  12  is in fluid communication with opening  36  and interior  38  of container insert member  28 , creating a channel which extends from proximal end  14  of connector element  12  to distal end  32  of container insert member  28 .  
         [0028]    As mentioned above, distal portion  37  of container insert member  28  is received in fluid container  41 . In an exemplary embodiment, distal portion  37  is dimensioned so that its outer diameter is substantially equal to or less than the inner diameter of opening  39  of container  41  allowing distal portion  37  to be received in container  41 . Opening  39  and distal portion  37 , and thus container  41  and container insert member  28 , may be coupled together in a number of ways, including, without limitation, bonding agents, ultrasonic welding, tongue and groove fittings, and interference fitting. Preferably, this coupling prevents leakage of any fluid. In an alternate embodiment, connector element  12  and container insert member  28  may be portions of a one-piece housing or connector.  
         [0029]    Distal portion  37  of insert member  28  has at least one window  42  therethrough, thereby fluidly connecting the interior of container  41  with interior  38 . In an exemplary embodiment, there are a plurality of windows  42  (e.g., four), spaced an equal distance apart from one another and extending around distal portion  37 . Windows  42  extend from distal end  32  to proximal portion  35  and are sized and spaced to maximize fluid flow from container  41  into interior  38  and to minimize remnant fluid in container  41 . In an exemplary embodiment, windows  42  extend substantially the entire length of distal portion  37  of container insert member  28 . As can be seen more clearly in FIGS. 6 and 7, windows  42  are arranged, configured, and dimensioned so that fluid in container  41  cannot pool around container insert member  28  if fluid container  41  is inverted since there is no wall or similar structure to impede the fluid flow. Rather, substantially all of the fluid in container  41  can and will flow into interior  38  through windows  42 , thereby minimizing remnant fluid in container  41 .  
         [0030]    Distal end  32  of container insert member  28  also may have a rounded exterior surface. A corresponding portion of interior  38 , located near distal end  32 , may also be rounded. A rounded distal end  32  further minimizes remnant fluid in container  41 . If container  41  is inverted, the fluid inside container  35  cannot pool on any outer surface of distal end  32  of container insert member  28 . Instead, the fluid will flow down the rounded outer surface and into interior  38  through windows  42 .  
         [0031]    In a preferred embodiment, container insert member  28  also has a radially extending flange  44  located near proximal end  30 . Flange  44  serves a two-fold purpose. First, flange  44  abuts lip  45  surrounding opening  39  of fluid container  41  to limit the insertion depth of container insert member  28 . Preferably, flange  44  is located near proximal portion  35  so that container insert member  28  can be inserted into the fluid container to a depth that exposes a substantial portion of each of windows  42  to the interior of container  41  while also leaving a collar  40  of sufficient length for coupling connector element  12  thereto. Second, flange  44  serves as a coupling surface to couple container insert member  28  to fluid container  41 . Flange  44  can be coupled to fluid container  41  in a number of ways, including, without limitation, via bonding agents, ultrasonic welding, tongue and groove fittings, and interference fitting. In an exemplary embodiment, an “o”-ring may also be included between flange  44  and container  41  to create a fluid seal and to further assist with coupling container insert member  28  to fluid container  41 , particularly if a glass fluid container is used.  
         [0032]    Referring back to FIG. 1, control device  10  also includes a valve element  46 . Valve element  46  has a proximal end  48 , a distal end  50 , and a longitudinal axis  52 . Valve element  46  is disposed within axial bore  20  of connector element  12  and interior  38  of container insert member  28 . In an exemplary embodiment, valve element  46  is supported by interior  38  of container insert member  28 . Particularly, distal end  50  of valve element  46  abuts the distal portion  31  of interior  38  of container insert member  28  such that valve element  46  may thereby be supported by the distal portion of interior  38 . As shown in FIGS. 1 and 6, valve element  46  is, when in a neutral, sealing position, (defined below) substantially coaxial with connector element  12  and container insert member  28 . Accordingly, axes  18 ,  34 , and  52  are substantially collinear when valve element  46  is in the neutral, sealing position.  
         [0033]    In an exemplary embodiment, valve element  46  may be formed partially or totally of elastomeric materials to facilitate deflection and sealing characteristics. In such embodiment, valve element  46  preferably includes a plug portion  54  and a shaft portion  56  extending in a distal direction from plug  54 . Plug portion  54  includes a flange portion  58  having a proximal surface  60  and a distal surface  62 . Proximally of flange portion  58 , plug portion  54  has a generally cylindrical configuration and extends to nose  64  having a proximal end surface  66 . Between proximal end surface  66  of nose  64  and proximal surface  60  of flange portion  58 , plug portion  54  is provided with a buckling section. Such section may be at a predetermined location laterally of axis  52  to facilitate non-axial buckling of such section. In an exemplary embodiment, this buckling section may be a notch  68 . As can be seen in FIGS. 1, 6, and  7 , the illustrated exemplary valve element  46  has a plurality of buckling sections or notches  68  located on plug portion  54  and shaft portion  56  to facilitate bending, buckling, bowing or canting of valve element  46  as detailed below. Also shown in FIGS. 1, 6, and  7 , the distal end  57  of shaft portion  56  may be rounded. This rounded end, which abuts and rests against the rounded distal portion  31  of interior  38  of container insert member  28 , also facilitates bending, buckling, bowing or canting of valve element  46 .  
         [0034]    Valve element  46  enables fluid control device  10  to provide a neutral, sealing position in one operative state, and to provide an actuated, open position in a second operative state. The closed condition or state is illustrated in FIG. 6 where proximal end surface  66  is substantially coplanar with distal end  14  of connector element  12 ; the open condition or state is illustrated in FIG. 7, where proximal end surface  66  is no longer coplanar with distal end  14  of connector element  12 . For the sake of convenience and with no intent to limit, the closed condition or state will be referred to as the closed state and the open condition or state will be referred to as the open state.  
         [0035]    In the closed state, valve element  46  is generally in a neutral, sealing position and is substantially its maximum length. In this closed state, plug portion  54 , associated with the valve element  46 , is in sealing engagement with axial bore  20  of connector element  12 . More specifically, proximal surface  60  of flange  58  is pressed into sealing engagement with valve seat  27  to form a primary seal between connector element  12  and plug portion  54  of valve element  46 . In the closed state of valve element  46 , a secondary seal is also formed between the circumferential surface of nose  64  and axial bore  20  at distal end  14 . Proximal end surface  66  of valve element  46  may be shaped and configured to be substantially coplanar and level with proximal end  14  of connector element  12  when valve element  46  is in the closed state. This substantially coplanar and level orientation is preferred in order to avoid reservoirs or crevices between proximal end surface  66  of valve element  46  and proximal end  14  of connector element  12  in which pooling of fluid and/or debris and/or bacterial contamination may result. Furthermore, the substantially coplanar and level orientation allows for an easily swabable surface for disinfection.  
         [0036]    Furthermore, in the closed state, shaft portion  56  of valve element  46  is located in axial bore  20  of connector element  12  and interior  38  of container insert member  28 . Preferably, distal end  50  of valve element  46  is rounded and, as mentioned earlier, rests on or abuts the distal potion  31  of interior  38 . Also, the distal portion of valve element  46  can move laterally with respect to connector element  12  and container insert member  28  while the proximal portion of valve element  46 , as a result of the relative smaller size of bore  20  with respect to interior  38 , can move laterally to a lesser degree, if at all, with respect to connector element  12  and container insert member  28 .  
         [0037]    As illustrated in FIG. 7, the open state of fluid flow control device  10  is achieved by compressing valve element  46  into container insert member  28  generally along axis  52 . This compression may be achieved in a preferred embodiment by connecting a common male Luer fitting  70  to proximal portion  19  of connector element  12 . By providing control device  10  with characteristics for being actuated by a common Luer fitting  70 , there is no need for a needle or similarly sharp instrument to access and to withdraw fluid from fluid container  41 . Of course, other means of compression are also contemplated, including using a blunt, elongated member to displace valve element  46 .  
         [0038]    In FIG. 7, valve element  46  is compressed into container insert member  28  along axis  52 . As used herein, the word “compress” and its derivatives refers to any position wherein the two ends of an elongate element are brought closer together. This may occur due to a shortening of the element along its axial length or due to a bending of the element off-axis which may or may not be accompanied by a shortening in the length of the element.  
         [0039]    As the male Luer fitting  70  is inserted into axial bore  20 , it initially contacts proximal end surface  66  of valve element  46 . Further insertion of fitting  70  places an axial load on valve element  46  which is distributed along the entire length of valve element  46 . In a preferred embodiment, this compressive force operates initially to break the secondary seal between nose  64  and axial bore  20 , and then to compress plug portion  54  primarily at the buckling section formed by notch  68 .  
         [0040]    As plug portion  54  collapses at notch  68 , plug portion  54  compresses along the side of valve element  46  at which notch  68  is formed, causing proximal end surface  66  to dip in the area of notch  68 . This effectively moves the area of contact between the Luer fitting  70  and proximal end surface  66  away from axis  52  and toward the side of plug portion  54  opposite notch  68 . This movement displaces a portion of valve element  46  away from axis  18  of connector element  12  in a first direction.  
         [0041]    As valve element  46  collapses along notch  68 , the additional force applied by insertion of fitting  70  may also operate to compress shaft portion  56  axially. With the compression of valve element  46 , the shaft portion  56  tends to cant, buckle, bow or otherwise bend (“cant” or “canting” hereafter for the sake of simplicity and without the intent to limit). This compression of shaft portion  56  tends to break the primary seal formed between surface  60  of plug portion  54  and valve seat  26  of connector element  12 . This movement of shaft portion  56  also displaces a portion of valve element  46  away from axis  34  of container insert member  28  in a second direction. In an exemplary embodiment, the displacement of a portion of a valve element  46  in the first direction may be in the same direction as the displacement of a portion of valve element  46  in the second direction. In another exemplary embodiment, the displacement of a portion of valve element  46  in the first direction may be in a different direction from the displacement of a portion of valve element  46  in the second direction. Also, distal end  57  of shaft  56  may slide along the rounded distal portion of interior  38  of container insert member  28  to facilitate canting and compression of shaft portion  56 . Having broken both the primary seal associated with the primary valve seat  26 , and the secondary seal associated with nose  64 , the channel is now opened to allow fluid to flow from the interior of container  41  to fitting  70 . In an exemplary embodiment, the fluid flows from the interior of container  41  through windows  42  to interior  38 . From interior  38 , the fluid flows through opening  36  into axial bore  20 , around valve element  46 , and into fitting  70 .  
         [0042]    Turning now to FIG. 8, a container wrapper member  72  is shown in isolation. In an exemplary embodiment, container wrapper member  72  may also be included to secure flange  44  of container insert member  28  to lip  45  of container  41 . Container wrapper member  72  may be coupled to flange  44  and lip  45  in a number of ways including bonding agents, ultrasonic welding, interference fitting, and tongue and groove fittings.  
         [0043]    While various descriptions of the present invention are described above, it should be understood that the various features can be used singly or in combination thereof. Therefore, this invention is not to be limited to the specific preferred embodiments depicted herein. Further, it should be understood that variations and modifications within the spirit and scope of the invention may occur to those skilled in the art to which the invention pertains. Accordingly, all expedient modifications readily attainable by one versed in the art from the disclosure set forth herein that are within the scope and spirit of the present invention are to be included as further embodiments of the present invention. The scope of the present invention is accordingly defined as set forth in the appended claims.