Abstract:
The present invention relates to a sterile closure device that is particularly suited for flexible containers, or pouches, that contain medical fluids. The sterile closure device provides a port for a conventional spike set to puncture in order to attach a patient feeding line. The sterile closure device features at least two protection mechanisms that enhance sterility. Between the two protection mechanisms is a sterile chamber that minimizes leakage of medical fluid from the flexible container when the protection mechanisms are breached by a the spike set. The sterile closure device also features finger support to facilitate the user in grasping and puncturing the sterile closure device.

Description:
[0001]    This application claims the benefit of U.S. Provisional Application No. 60/417,917, filed Oct. 11, 2002. 
     
    
     
       FIELD OF THE INVENTION  
         [0002]    The present invention relates to closure devices, and more particularly, sterile closure devices that are suitable for pouches containing medical fluids that can be intravenously or enterally administered to a patient. The closure devices of the present invention maintain sterility of the pouch when used with conventional spike sets.  
         BACKGROUND OF THE INVENTION  
         [0003]    Many individuals in hospitals or nursing homes cannot orally take nourishment or medication. These individuals, or medical patients, typically receive medical fluids containing the requisite nourishment and/or medication intravenously or enterally via a patient feeding line that is connected to a container holding such medical fluids. These medical fluids are commonly packaged in flexible containers, for example flexible pouches. Such a pouch is typically constructed from two webs of plastic film that have a series of edge seals so as to form a bag defining a reservoir to contain the medical fluid. A closure device is placed between the webs during the sealing process to create a communication between the reservoir and the patient feeding line.  
           [0004]    The medical fluids that are typically administered to a patient need to be sterile. Thus, the seal created by the closure device between the flexible pouch and the patient feeding line should be airtight. The closure device serves to prevent contaminants from entering the patient feeding line and harming the patient. Moreover, for oxygen sensitive medical fluids, the closure device prevents oxygen from entering the opening of the flexible pouch.  
           [0005]    Prior art closure devices typically have a single barrier that prevents the contents of the container from being exposed to the environment. In the event that this barrier ruptures, for example during a retorting process, the medical fluid would leak from the container and be exposed to non-sterile conditions and oxygen. Prior methods of maintaining sterility have also included swabbing or wiping the outside surface of the closure device with alcohol prior to spiking.  
           [0006]    Furthermore, the barrier of closure devices are typically located near the opening of the package itself, medical fluid commonly leaks from the container as a conventional spike set, or spike, is used to puncture the barrier. An example of a conventional spike set is COMPAT® piercing spike sets distributed by Novartis Nutrition Corporation (Minneapolis, Minn.).  
           [0007]    Thus, there is a need for a novel closure device that presents additional protection in the event that the closure device ever ruptures by featuring multiple protection mechanisms. Furthermore, the novel closure device must be easily implemented in a flexible pouch system and be compatible with flexible spikes.  
         SUMMARY OF THE INVENTION  
         [0008]    It is thus an object of the present invention to provide a closure device that is suitable for use with flexible pouches and compatible with spikes. The closure device has, for example, a lenticular shape, that allows it be inserted in between the two sides of a flexible pouch. The closure device forms the exit port for medical fluid from the flexible bag.  
           [0009]    It is yet another object of the present invention to provide an inexpensive and easily manufactured closure device. The closure device, for example, is of a unitary construction made entirely of a single material, for example a polymer. Three parts of the closure device are identifiable as a base, a mid-section and a finger support. Extending through each part is a cylindrical member with a diameter that is sized to receive a spike or other device used to connect a patient feeding line.  
           [0010]    Yet a further object of the present invention is to provide a closure device that features at least two protection mechanisms, or seals. For instance, the inlet of the cylindrical member is sealed by a weakened area that is penetrable by a spike. The outlet of the cylindrical member is then covered by a seal, for example, a foil seal. Disposed between the weakened area and the seal is a sterile chamber that is physically separated from the flexible container by the weakened area. The sterile chamber serves to provide additional protections against contamination during the spiking process or the sterilization process, for example retorting.  
           [0011]    Another object of the present invention is to provide a closure device that can be easily handled and gripped by a user. The closure device has a finger support which, for example, takes the shape of wings. The user can grip the edges of the wings with one hand with a spike in the other hand.  
           [0012]    Numerous, other objects, features and advantages of the present invention will readily become apparent from the following detailed description, from the claims and from the accompanying drawings. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0013]    The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate an exemplary embodiment of the present invention.  
         [0014]    [0014]FIG. 1 is a front view of a flexible pouch in connection with a closure device in accordance with an embodiment of the present invention;  
         [0015]    [0015]FIG. 2 is a side elevational view of the flexible pouch and the closure device in accordance with an embodiment of the present invention;  
         [0016]    [0016]FIG. 3 is a perspective view from an upper, front, right-side vantage of the closure device without a peelable seal in accordance with an embodiment of the present invention;  
         [0017]    [0017]FIG. 4 is a perspective view from a front, right-side vantage of the closure device without a peelable seal in accordance with an embodiment of the present invention;  
         [0018]    [0018]FIG. 5 is a front elevational view of the closure device depicted in FIGS. 3 and 4;  
         [0019]    [0019]FIG. 6 is a side elevational view of the closure device depicted in FIGS. 3, 4 and  5 ;  
         [0020]    [0020]FIG. 7 is a top plan view of the closure device depicted in FIGS. 3, 4,  5  and  6 ;  
         [0021]    [0021]FIG. 8 is a cross-section of the closure device without a peelable seal in accordance with an embodiment of the present invention taken along line A-A of FIG. 5;  
         [0022]    [0022]FIG. 9 is a cross-section of the closure device without a peelable seal in accordance with an embodiment of the present invention taken along line B-B of FIG. 6;  
         [0023]    [0023]FIG. 10 is a cross-section of the closure device without a peelable seal in accordance with an embodiment of the present invention taken along line C-C of FIG. 5; and  
         [0024]    [0024]FIG. 11 is a perspective view from an upper, front, right-side vantage of the closure device with a peelable seal in accordance with an embodiment of the present invention. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0025]    Referring to FIGS. 1 and 2, flexible pouch  10  is formed from at least a single sheet of flexible material that has no or low permeability to oxygen. The sheet may be a monolayer of the flexible material or composed of multiple layers of different flexible materials. For example, flexible materials include, but are not limited to, polyester, ethylene vinyl acetate, cast polypropylene, aluminum oxide coated nylon, aluminum, biaxially oriented nylon and multiple layers thereof . Typically, however, flexible pouch is formed from two sheets of flexible material. Edges  12  of flexible pouch  10  are sealed, for instance by heat, ultrasound or impulse, such that edges  12  define reservoir  14  within flexible pouch  10 . Reservoir  14  contains a medical fluid providing nutrition to a patient.  
         [0026]    Connected to a side of flexible pouch  10  is closure device  20  which serves as the exiting point for the medical fluid from flexible pouch  10 . Closure device  20  is molded as a single unitary construction, for example, from a polymeric material that has low permeability to oxygen. The appropriate polymeric material should be capable of forming an airtight seal with the material from which flexible pouch  10  is made. Furthermore, the polymeric material should be sterilizable, for example by a retort sterilization process. Examples of polymeric materials include, but are not limited to, high density polyethylene, polypropylene, ethylene vinyl acetate, polyvinylidene chloride, nylon and combinations thereof. Preferably, closure device  20  is made from polypropylene. Closure device  20  is attached to flexible pouch  10  by methods including, but not limited to heat induction, ultrasonic welding and friction welding or any other means as known in the art. Although closure device  20  can be incorporated into any type of container, e.g., a bottle, tube or other form of packaging as known to a skilled artisan, it is preferred that the closure device  20  be used with a flexible pouch.  
         [0027]    [0027]FIGS. 5 through 10 illustrate the details of the structure of closure device  20 . Closure device  20  generally comprises base  22 , mid-section  24  and finger support  26 . Although base  22  can have any type of geometric shape, for instance a cylinder as in the prior art. A flexible pouch is essentially two flat sheets, and when a cylindrical shape is inserted between the two flat sheets additional stresses are generated in the flexible pouch around the closure device. These additional stresses may lead to breakage or rupture of the container. In accordance with this concern, base  22  is preferably lenticular, or boat-shaped.  
         [0028]    Base  22  has at least a top surface  28 , bottom surface  29  and two, generally opposite facing side surfaces  30 ,  32  that taper into partitions  34 ,  36 . Bottom surface  29  is perpendicular the lengthwise axis of flexible pouch  10  and is the surface of base  22  that is closest to the medical fluid in flexible pouch  10 . Facing side surfaces  30 ,  32  serve as the attachment points of closure device  20  to flexible pouch  10 . To facilitate and enhance securement to flexible pouch  10 , each facing side surface  30 ,  32  features axially spaced and integrally formed ribs  38 . Any number of ribs  38  can be provided on each facing side surface  30 ,  32 . Alternatively, ribs  38  can be entirely eliminated. Partitions  34 ,  36  traverse centrally through ribs  38  and help maintain the spacing of ribs  38 .  
         [0029]    In the center of base  22  and extending therethrough is cylindrical member  40 . Cylindrical member  40  outwardly extends from bottom surface  29  of base  22  through mid-section  24  and ultimately ends in finger support  26 . At finger support  26 , cylindrical member  40  has outlet  42 . Outlet  42 , for example, is recessed. At the end opposite from outlet  42  is inlet  44 . Prior to use and spiking, inlet  44  is closed off and, for example, sealed to form weakened area  46 . Alternatively, instead of having weakened area  46  block inlet  44 , weakened area  46  can be disposed anywhere along the entire length of cylindrical member  40  provided that it blocks cylindrical member  40 . Weakened area  46  serves as a protection mechanism or seal by creating a barrier between reservoir  14  of flexible pouch  10  and the exterior environment to maintain both sterility and cleanliness. Furthermore, weakened area  46  prevents any medical fluid from leaking out of flexible pouch  10 . Perpendicular from weakened area  46  is extension  48  which is optional. Extension  48  serves to facilitate manufacturing of closure device  20 . The diameter of cylindrical member  40  should be sized to receive a spike. For example, the diameter can range from about 0.5 mm (approximately 0.020 inches) to about 12 mm (approximately 0.47 inches). It is preferred, although not necessary, that the diameter of weakened area  46  be larger than the diameter of a spike. In order to make weakened area  46  pierceable, the outer perimeter of weakened area  46  can have a thickness less than the thickness of the center of weakened area  46  as shown in FIG. 8. Other methods to render weakened area  46  pierceable include, but are not limited to, scoring and grooving the weakened area  46 .  
         [0030]    Attached to top surface  28  is mid-section  24  which features three discrete elements which are cylindrical member  40  and two spacers  50 ,  52 . Spacers  50 ,  52 , for example, are rectangular in shape and parallel to each other and perpendicular to the long axis of base  22  and top surface  28 . Spacers  50 ,  52  provide a means for separating finger support  26  from top surface  28  and a means for extending the length of cylindrical member  40  which also extends through base  22  as previously discussed. Moreover, spacers  50 ,  52  facilitate manufacturability of closure device  20 . Spacers  50 , 52  also provide of method of orienting finger support  26  to base  22 . Although mid-section  24  can be removed from closure device  20 , it is preferably included which will be made apparent in the discussion below. Although spacers  50 ,  52  can be positioned anywhere within mid-section  24 , spacers  50 ,  52  are preferably positioned one each side of cylindrical member  40 . Additionally, in alternative embodiments, the spacers  50 ,  52  can be excluded from mid-section  24  in their entirety.  
         [0031]    Continuous with mid-section  24  is finger support  26 . Finger support  26  can be, for example, a flange around outlet  42  of cylindrical member  40 . Finger support  26 , for example, is predominantly planar and parallel to top surface  28  and bottom surface  29  of base  22 ; however, sections of the perimeter can be flipped or directed outwardly from base  22  to form wings  60 ,  62 . As illustrated in FIGS. 6 and 9, wings  60 ,  62  are semi-circular in shape, although any other shape is suitable. Wings  60 ,  62  provide a means for the user to grip closure device  20  in order to keep closure device  20  steady when a spike is being used to puncture weakened area  46  of base  22 . Additionally, wings  60 ,  62  help prevent the fingers of the user from touching cylindrical member  40  and outlet  42 , thus, ensuring sterility and cleanliness. Along the two perimeter sections between wings  60 ,  62 , are two arcs  64 ,  66 . These arcs  64 ,  66  are optionally provided and reduce the material of finger support  26 . Attached to, or formed as a part of the outer surface of, finger support  26  is seal  70 . Referring to FIG. 11, for example, seal  70  hermetically covers outlet  42  and has no or low permeability to oxygen. Seal  70  should be defeatable in some manner, for example by removal or by penetration. Examples of materials suitable for use as seal  70  include, but are not limited, to a peelable foil seal, a penetrable foil seal, a penetrable polymeric membrane, a screw-on cap, a twist-off cap and a snap-on cap. Preferably, seal  70  is a foil laminate seal that is adhesively sealed to finger support  26 . The foil laminate for seal  70  can be a single or multi-laminate material suitable to provide a peelable seal with the surface of finger support  26 . The foil, for example, is heat-sealed to finger support  26 , by flowing a heated food grade hot melt adhesive between the seal  70  and finger support  26 . Alternatively and more preferably, the foil seal is thermally self-sealed when the outer layer of the foil is compatible with the polymeric material of closure device  20 . Seal  70  provides an additional protection mechanism that isolates the medical fluid contamination. In the event weakened area  46  ever is broken unintentionally, for example during sterilization, the medical fluid is still protected by seal  70 . Thus, there are two layers of protection built into closure device  20  of the present invention: weakened area  46  and seal  70 . Within cylindrical member  40  between weakened area  46  and seal  70  is chamber  72  which remains sterile and physically separated from flexible pouch  10  until seal  70  is breached provided that the entire closure device  20  and pouch  10  have been sterilized.  
         [0032]    Optionally included is raised surface  80  that surrounds outlet  42 . Raised surface  80 , for example, is formed from the polymeric material that makes up finger support  26 . Raised surface  80 , for example, tapers into points on each side of outlet  42 . The incorporation of raised surface  80  when using seal  70  that is a foil laminate makes it easier to peel seal  70  away from the surface of finger support  26 . Raised surface  80 , for example, creates a starting point, such that when a user begins to remove the seal  70 , all of the force expended by the user is concentrated at a localized point, i.e., the end of the taper.  
         [0033]    To administer the medical fluid to a patient using closure device  20  of the present invention, the user first grips closure device  20  by grasping wings  60 ,  62  of finger support  26 . Next, the user breaches seal  70 , for instance by peeling, to expose outlet  42  of cylindrical member  40 . The sharp end of a spike is then plunged through chamber  72  of cylindrical member  40  penetrating weakened area  46 , thus releasing the medical fluid into the patient feeding line.  
         [0034]    In the prior art closure devices, the outlet for the medical fluid to flow is coplanar with the bottom of the container holding the medical fluid. When the closure device is spiked, as soon as the tip of the spike punctures the closure device, the medical fluid immediately flows and leaks from the container. An additional feature of closure device  20  of the present invention is that it minimizes any leaks during the spiking process. As a spike is plunged into cylindrical member  40 , it first enters outlet  42  and immediately contacts chamber  72 . Because the diameter of chamber  72  is slightly smaller than that of the spike set, the spike set is in physical contact with the inner wall of chamber  72  as soon as the spike enters chamber  72 . Thus, a physical barrier is formed to prevent leakage, as the spike moves through chamber  72 . When the tip of the spike finally breaches weakened area  46 , any fluid that escapes from flexible pouch  10  enters the spike, not the area between the spike and the inner wall of chamber  72 .  
         [0035]    In an alternative embodiment, the mid-section can be entirely eliminated; thus the top surface of the base would be flush against the outer surface of the finger support. The length of the cylindrical member is shortened and the portion of the cylindrical member within the base becomes the entire chamber. In yet another alternative embodiment, the wings of finger support can be directly attached to the surface of the base and thus form extensions of the top surface or bottom surface of the base.  
         [0036]    In yet another alternative embodiment, closure device includes a base with a mid-section without any spacer. Thus, the cylindrical member extends through and projects outwardly from base. In this embodiment there is no finger support. Both the inlets and outlets of the cylindrical member are sealed by protection mechanisms as discussed above with one protection mechanism, for example a weakened area, being disposed anywhere along the length of the cylindrical member and an additional protection sealing the outlet of the cylindrical member.  
         [0037]    It is understood that while the present invention has been described in conjunction with the detailed description thereof that the foregoing description is intended to illustrate and not limit the scope of the invention, which is defined by the scope of the following claims. Other aspects, advantages and modifications are within the scope of the claims.