Abstract:
A medication container adapter that utilizes a push-pull valve for adapting medication containers for use with enteral syringes that are filled on semi-automatic and automatic filling machinery. The enteral syringes are filled when the medication container is in the inverted filling position. The push-pull valve comprises of a stationary portion and a poppet slidably inserted into the stationary portion. The poppet is an annular member having a central channel and a fluted axial outlet from the central channel. The push-pull valve can be configured to be pressed onto an existing medication container adapter or manufactured as an integrated part of the medication container adapter so that it can either be screwed onto or pressed into the medication container neck.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application is a continuation-in-part of U.S. application Ser. No. 13/788,849 filed Mar. 7, 2013, and a continuation-in-part of PCT/US2015/013217 filed Jan. 28, 2015, both of which are incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the invention 
         [0003]    The present invention relates generally to enteral syringe packaging equipment and more specifically to an adapter cap incorporating a push-pull valve optimized for use in a fully or partially automated system for preparing patient-specific doses of selected pharmaceutical liquid medication for administration by syringe. 
         [0004]    2. Description of the Background 
         [0005]    Oral syringes are used to dispense liquids into the mouth. Enteral syringes are used to dispense liquids into the gastro-intestinal tract through a tube. As shown in  FIG. 1 , oral syringes utilize a male tapered tip. Enteral syringes utilize a female tip as shown in  FIGS. 2A &amp; 2B . 
         [0006]    Hospital pharmacists prefer to fill just one type of syringe because they typically do not know whether a prescription will ultimately be administered orally or enterally. Another issue of great concern relates to mistaken use of syringes. Syringes intended to be dispensed into the mouth or into an enteral tube can, inadvertently, though rarely, be dispensed into an intravenous (IV) patient port. Such mistakes have caused injury and death to patients. Both of these problems have recently been addressed by the Global Device Suppliers Association (GEDSA). This industry group has introduced new devices referred to as ENFIT™ which include enteral syringes. The ENFIT™ devices are not compatible with luer connections or any other type of small bore medical connectors. This ENFIT™ design prevents the misconnection of enteral syringes to the patient&#39;s tubing port. As a result of the GED5A organizations efforts, the International Standards Organization created ISO CD 803069-3 which specifies the safe design for an enteral feeding connection. The new ENFIT™ enteral syringes comply with ISO CD 80369-3, can be used to administer medication orally or enterally, and cannot easily be connected to an incorrect patient tubing port. 
         [0007]    As shown in  FIG. 1 , oral syringes have a tapered tip which can be used with a medication container to syringe adapter with an elastomer valve for filling the syringe when the container is in the inverted position. 
         [0008]    The tapered tip of the oral syringe (See  FIG. 1 ) penetrates the elastomer valve which enables the syringe to extract the liquid from the medication container. This adapter arrangement is not suitable for filling enteral syringes as the enteral syringe has a female fitting on the tip and is not compatible with the elastomer valve adapter used for the oral syringe. 
         [0009]    To address this problem, a new Push-Pull Valve Adapter (for which this patent application is based) was developed by the Inventors specifically for use with the female tip of the enteral syringe (refer to  FIGS. 5 &amp; 6 ). 
         [0010]    Prior to filling the syringe, the valve is closed ( FIG. 5 ). During the filling of the syringe, a mechanical actuator  FIG. 5  (valve opener/closer), located at the fill station, opens the valve  FIG. 6 . When the syringe has been filled, the same mechanical actuator closes the valve. 
         [0011]    The initial design of the enteral syringe tip caused excess liquid to accumulate in the tip of the syringe which caused unacceptable fill accuracy for the smaller size enteral syringes. A new design which incorporates a center nozzle within the syringe discharge port addressed this problem ( FIG. 5 ). 
         [0012]    The change in the design of the discharge port of the enteral syringe required a new design for the syringe to medication adapter valve. This design changes obviated the prior art. A new adapter needed to fill both the smaller enteral syringes that had the center nozzle port ( FIG. 5 ) as well as the larger syringes which did not have the center nozzle port ( FIG. 11 ) without using change parts. 
         [0013]    Thus, as shown in  FIG. 2 , two versions of enteral syringes now exist. As shown in  FIG. 2(A)  larger enteral syringes (typically 5 cc and above) utilize an internally-threaded female tip and no center nozzle. As shown in  FIG. 2(B)  smaller enteral syringes (typically 0.5 ml-3 ml) utilize an internal tapered or slip-nozzle with an enteral threaded female tip and a center nozzle. 
         [0014]    Automated filling systems have been developed by Baxa, Inc., For Health Technologies, Inc., Intelligent Hospital Systems, Applicant National Instruments Co. (see, for example, Applicant&#39;s U.S. Ser. No. 13/788,849 filed Mar. 7, 2013 and others for the automated filling of syringes). However, the degree of automation in the hospital pharmacy for the packaging of oral/enteral syringes is limited due to the wide array of different syringes to fill and different medicine containers to fill them from. Bulk medications are commonly provided in variously sized bottles or containers having threaded screw caps that must be removed and replaced with container-to-syringe adapter caps. Most any attempt at automated filling of any syringes requires a modification to standard manufacturer-supplied medicine containers. Semi-automated and automated filling of syringes requires that the medication container be in the inverted position while the syringe is being filled. It is also necessary that the medication container cap be open during the time that the syringe is being filled, and closed when the syringe has been filled to prevent leakage. Thus, the manufacturer-supplied screw-on caps must be removed and replaced by an adapter cap that allows the syringe to be connected to the medication container. To fill oral syringes it is known to use an adapter cap with an elastomeric valve that allow the syringe tip ( FIG. 1 ) to penetrate the inverted container. The tapered tip of the oral syringe would penetrate the elastomer valve while the medicine container is held in an inverted position, enabling the syringe to extract the liquid from the medication container without leakage. 
         [0015]    Unfortunately, the elastomeric seal-type adapter cap does not work with enteral syringes which are manufactured in a variety of sizes with differing plunger configurations ( FIGS. 2A, 2B ). The prior art adapter arrangement is not suitable for filling enteral syringes ( FIGS. 2A, 2B ) since the enteral syringe has a female fitting on the tip and is not compatible with the elastomer valve adapter used for the oral syringe. 
         [0016]    Given the diversity of enteral syringes and medicines available, any semi-automated (or fully-automated) system will need sufficient dexterity to manipulate all the myriad prescription bottles containing the pharmaceuticals to be dispensed as well as variously sized enteral syringes, bringing them together in a controlled environment to quickly and accurately fill and label each syringe and to verify its work as it proceeds in order to avoid errors in the process. Existing adapter caps are incapable of use with enteral syringes that are being filled on an automated or semi-automated basis when the medication container is in the inverted position. Consequently, existing adapter caps do not address the needs of medical institutions desiring a semi-automatic or automatic enteral syringe filling system when the medication container is in the inverted position. The present invention was developed to fill this void. 
       SUMMARY OF THE INVENTION 
       [0017]    To address the need to fill enteral syringes, on a semi-automatic or automated basis, with the medicine container held in the inverted filling position, a push-pull adapter cap is herein disclosed. When filling the syringe the valve is open. After the syringe has been filled the valve is closed. The push-pull valve is open or closed by a mechanical actuator at the automated or semi-automated filling station. 
         [0018]    The push-pull adapter cap disclosed herein, when used with an enteral syringe filling system, enables hospital pharmacists to simplify and streamline their task, increasing the number of prescriptions that can be filled in a day, and improving patient safety and care by minimizing medication errors and the consequences that ensue. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0019]    The objects, features, and advantages of the present invention will become apparent from the following detailed description of the preferred embodiments and certain modifications thereof when taken together with the accompanying drawings in which like numbers represent like items throughout and in which: 
           [0020]      FIG. 1  is a perspective view of a conventional oral syringes with tapered tip. 
           [0021]      FIG. 2(A)  is a perspective view of a large-sized conventional enteral syringe with internally-threaded female tip. 
           [0022]      FIG. 2(B)  is a perspective view of a smaller-sized conventional enteral syringe with an internal tapered or slip-nozzle and a female tip. 
           [0023]      FIG. 3  is a perspective exploded view of a push-pull adapter cap  10  for retrofit application to a standard manufacturer-supplied medication container cap such as a Baxa™ or equivalent valve-less medicine container adapter cap with opening. 
           [0024]      FIG. 4  is a perspective view of the push-pull adapter cap  10  of  FIG. 3  illustrating how it interfaces an automated filling system. 
           [0025]      FIGS. 5-6  are sequential perspective views of the push-pull adapter cap  10  of  FIGS. 3-4  illustrating how it interfaces a smaller-sized enteral syringe (with internal tapered slip-nozzle and enteral threaded female tip) while in the automated filling system. 
           [0026]      FIG. 7  is a side view of the poppet  84  used in the push-pull adapter cap  10  of  FIGS. 3-6 . 
           [0027]      FIG. 8  is an end cross-section of the poppet valve of  FIG. 7 . 
           [0028]      FIG. 9  is a side cross-section of the press-on ring  60  used for attaching the push-pull adapter cap  10  of  FIGS. 3-8  to a standard manufacturer-supplied medication container adapter cap. 
           [0029]      FIG. 10  is a side cross-section of a modified press-in version used for attaching the push-pull adapter cap  10  inside the neck of a standard manufacturer-supplied medication container cap. 
           [0030]      FIGS. 11-12  are sequential perspective views of the push-pull adapter cap  10  of  FIGS. 3-6  that illustrate how it interfaces a larger-size enteral syringe lacking a center nozzle.  FIGS. 6 and 12  illustrate the device&#39;s ability to adapt to both small syringes (with nozzle) and large syringes (w/o center nozzle). 
           [0031]      FIG. 13  is a cross-section of the poppet valve of the present invention inserted into a large enteral syringe and illustrating the poppet valve circumferential seal surfaces on the large enteral syringe in accordance with the invention.  FIG. 14  is a cross-section of the poppet valve of the present invention inserted into a small enteral syringe and illustrating the poppet valve circumferential seal surfaces on the small enteral syringe in accordance with the invention. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0032]    For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the exemplary embodiment illustrated in the drawings and described below. The embodiment disclosed is not intended to be exhaustive or limit the invention to the precise form disclosed in the following detailed description. Rather, the embodiment is chosen and described so that others skilled in the art may utilize its teachings. It will be understood that no limitation of the scope of the invention is thereby intended. The invention includes any alterations and modifications in the illustrated device, the methods of operation, and further applications of the principles of the invention which would normally occur to one skilled in the art to which the invention relates. 
         [0033]      FIG. 3  is a perspective exploded view of a push-pull adapter cap  10  for retrofit application to a standard manufacturer-supplied (Baxa™ or Baxa equivalent) medicine container cap or equivalent valve-less medicine container cap with opening. For purposes of definition, this pre-existing medicine container cap is herein designated the “OEM cap.” Adapter cap  10  generally comprises a stationary portion  12  for attachment to the OEM cap, a poppet  84  slidably inserted into the stationary portion  12 , a plurality of O-rings inclusive of a fluid seal  94  and two poppet seals  92 ,  96 . 
         [0034]    Stationary portion  12  comprises an annular body with a central passage  22  there through, the central passage  22  being defined by an inner wall having a specific progression of diametric variations. At one end of the body of stationary portion  12 , where stationary portion  12  attaches to the top of the manufacturer-supplied medicine container cap, central passage  22  has a relatively large diameter sized to conform to and receive the nozzle of the manufacturer-supplied medicine container cap as described below with reference to  FIG. 8 . This forms a “press-fit” seal. It will be understood by one of ordinary skill in the art; however, that stationary portion  12  may be sized to fit other manufacturer-supplied caps by different means based on design preference, such as a screw-on connection. 
         [0035]    Central passage  22  continues partially through stationary portion  12  at a relatively constant diameter but then constricts at a shoulder  98  to a smaller diameter sized to accommodate the elastomer poppet  84 , as will be described further herein, which protrudes from the distal end of passage  22 . The outer wall of stationary portion  12  further comprise two spaced annular flanges  24  separated by an annular groove  26  for alignment with a stationary yoke of the filling station, as further described herein. Similarly, the outer wall of poppet  84  is equipped with two spaced annular flanges  89  separated by an annular groove  88  for alignment with a movable yoke of the filling station, as further described herein. 
         [0036]      FIG. 4  is a perspective view of the push-pull adapter cap  10  of  FIG. 3  illustrating how it interfaces an automated filling system. The automated filling system employs at least one anchoring yoke and at least one poppet-manipulating yoke, although one skilled in the art will recognize that counter-opposed pairs of such yokes may be used. The anchoring yoke(s) fit within the annular groove  26  of stationary portion  12  described above to thereby securely hold the medicine container by its manufacturer-supplied cap in a fixed position. The poppet-manipulating yoke fits within the annular groove  88  of poppet  84  described above to thereby insert and/or extract the poppet  84  from the stationary portion  12 , thereby closing or opening the valve. 
         [0037]      FIGS. 5-6  are sequential cross-sections of the push-pull adapter cap  10  of  FIGS. 3-4  illustrating how it interfaces an enteral syringe while in the automated filling system. Note that the syringe in  FIGS. 5-6  is a smaller-size enteral syringe with female tip and internal tapered slip-nozzle. In adapter cap  10  the central passage  22  continues approximately two-thirds through the stationary portion  12  at a relatively constant diameter d 1 , to a point approximately even with the lower flange  26 . However, that constant diameter passage is interrupted at about its midpoint by a shallow annular notch  97 . Notch  97  provides for snap-fit capture of the OEM cap by its nozzle, which as shown is typically provided with a distal flange for snap-fit of a nozzle cap. The central passage  22  continues at constant diameter d 1  to a shoulder  98  where is constricts to a smaller diameter d 2  sized to accommodate the elastomer poppet  84 , as will be described further herein, which protrudes from the distal end of passage  22 . Poppet  84  likewise has a central passage  85  leading from a radial inlet  87  to an axial outlet  86 . Note that the tip of poppet  84  is externally-tapered yet the central passage  85  is cylindrical leading to axial outlet  86 . This way, the tip of poppet  84  exactly fits the moat between the enteral syringe female tip and internal tapered slip-nozzle, preventing any accumulation of medicine and undesired leakage. 
         [0038]    In operation, when the poppet  84  is fully extracted as seen in  FIG. 5  the inlet  87  is sealed within the smaller diameter d 2  portion of passage  22  and forms a fluid-tight seal. Conversely, when the poppet  84  is fully inserted as seen in  FIG. 6  the inlet  87  pushes above shoulder  98  and is freed within the larger diameter d 1  portion of passage  22 . Medicine is free to flow through the poppet  84  as seen by the arrows of  FIG. 6  for filling of a syringe (below). 
         [0039]      FIGS. 7 and 8  are a cross-section and side view of the poppet  84 , which is an annular member formed with a plurality of grooves  101 - 105  spaced axially, and central passage  85  running centrally and axially and leading from a radial inlet  87  to an axial outlet  86 . Radial inlet  87  may be any one or more inlet-passages extending radially into poppet  84  and in fluid communication with passage  85 . Outlet  86  is enlarged and inwardly-fluted to receive and conform to the tapered nozzles of most enteral syringes. The grooves  101 - 105  include a lowermost groove  101  for receiving the smaller articulating yoke of the filling system which thereby inserts and/or extracts the poppet  84  from the stationary portion  12 , thereby closing or opening the valve. In addition, three grooves  102 ,  103  and  105  are provided for three O-rings, inclusive of a groove  105  for a poppet seal  94  above the inlet  87  for sealing the poppet  84  against the shoulder  98  when fully open, and two lower grooves  103 ,  105  below the inlet  87  for fluid seals  95 ,  96  thereby preventing leakage out around poppet  84 . 
         [0040]      FIG. 9  is a side cross-section of the press-on ring  60  used for attaching the push-pull adapter cap  10  of  FIGS. 3-6  to a standard manufacturer-supplied medication container cap. It is noteworthy that distal end of stationary portion  12  forms a nozzle through which the smaller diameter d 2  portion of passage  22  passes, and the inner walls of this nozzle are formed with two spaced grooves forming  0 -ring seats  101  as shown for seating the fluid seals  95 ,  96  of poppet  84  when it is in its fully extracted position, and thereby ensuring a fluid-tight closure. 
         [0041]    At the distal end of stationary portion  12  the outer diameter of the nozzle is sized to fit inside the female tip of an enteral syringe. The fluted outlet  86  of poppet  84  is configured to receive and conform to the tapered nozzles of most enteral syringes. This particular confirmation is well-suited for attachment to all variety of enteral syringes inclusive of a female tip with or without nozzles. 
         [0042]    One skilled in the art will understand that other configurations may be used for attachment to other medicine containers. For example, the inner wall of the adapter cap along d 2  may be defined by a simple inwardly-threaded connection for screw-insertion onto the threaded container neck. Alternately, the inner wall of the adapter cap  10  along d 2  may be formed with a series of integrally formed inwardly-directed circular gripping ribs for gripping the neck of a medicine container by its threads. 
         [0043]      FIG. 10  is a side cross-section of a modified press-in version used for attaching the push-pull adapter cap  10  inside the neck of a standard manufacturer-supplied medication container cap. Rather than fitting around the medicine container neck the ring fits inside, sealing by a plurality of resilient annular ribs  107  thereby ensuring a fluid-tight closure. 
         [0044]    Alternatively, the ring may fit outside the medicine container neck using a plurality of inwardly-directed resilient annular ribs  107  to ensure a fluid-tight closure. In this case, as the neck of a medicine container is forced into the central void, the ribs  107  engage the threads on the outside of the neck of the bottle and flex slightly to permit the threads to pass. Once past, the ribs  107  spring back toward their original position and press against the neck to engage the threads and secure the adapter cap  10  to the container. Whether male or female, the flexure of the ribs  107  permits the adapter cap  10  to accommodate size variations in outside neck diameter and thread finish, and create a fluid-tight seal without the need for a specific thread pitch. The foregoing is set forth in more detail in co-pending application Ser. No. 13/788,849 filed Mar. 7, 2013, which is herein incorporated by reference in its entirety. 
         [0045]      FIGS. 11-12  are sequential perspective views of the push-pull adapter cap  10  of  FIGS. 3-9  illustrating how it interfaces with both the larger-size enteral syringe lacking a center nozzle, and the smaller size enteral syringe with center nozzle thereby illustrating the device&#39;s ability to adapt to both small syringes(with nozzle) and large syringes (w/o center nozzle). As above, the tip of poppet  84  is externally-tapered and exactly fits the orifice of the enteral syringe female tip preventing any accumulation of medicine in the smaller enteral syringe tip with center nozzle. Thus the tip of the poppet valve is able to be used with both the small enteral syringe with center nozzle and the larger enteral nozzle without the center nozzle. 
         [0046]      FIG. 13  is a cross-section of the poppet valve  84  of the present invention inserted into a large enteral syringe and illustrating the poppet valve circumferential seal surfaces on the large enteral syringe lacking a center nozzle. As above, the tip of poppet  84  is externally-tapered, i.e., has a tapered outer diameter that exactly mates (“taper-locks”) with the outermost internal surface of the large enteral syringe female tip to create a first circumferential seal  112 . 
         [0047]      FIG. 14  is a cross-section of the poppet valve  84  of the present invention inserted into a small enteral syringe and illustrating the poppet valve circumferential seal surfaces on the small enteral syringe with internal center nozzle. The poppet valve  84  is configured as above for the first circumferential seal  112  plus the poppet central channel has a tapered outlet configured to mate with the outermost external surface of the enteral syringe nozzle to create a second circumferential seal  114 . For the smaller enteral syringes these two seals “taper-lock” both to the outermost internal surface and to the innermost diameter of the internal nozzle of smaller enteral syringes. Despite the type of enteral syringe this configuration completely eliminates unwanted fluid buildup and inaccurate filling volumes. 
         [0048]    It should now be apparent that the above design interfaces with and enables opening and closing the flow of medication to enteral syringes with a female tip with or without internal slip-nozzles while the medication container is inverted. As such, the time to load and unload, or upright and invert, the medication container between syringe fillings is eliminated. In addition, the medication container can also be shaken in an inverted position before, during or after a syringe filling operation, when the medication so requires. 
         [0049]    One skilled in the art will understand that the push-pull cap  10  may further comprise a 2D barcode to enable easy tracking of the medication container bearing that cap. Each barcode (or possibly RFID tag or other label) preferably references the following information:
       Batch number   Expiry date   Storage instructions   Product name   Strength   Name of the active ingredient(s)   Dose form   Warning statements   NDC number (National Drug Code)   Does product need to be shaken before use? If so, how often?   Does product need to be refrigerated before use? If so, temp?   Does product need to be protected from light?   Volume of original bulk medication container?       
 
         [0063]    In addition, molded surface features or textures may be provided on the outer surface of each cap to provide a gripping surface. 
         [0064]    Having now fully set forth the preferred embodiment and certain modifications of the concept underlying the present invention, various other embodiments as well as certain variations and modifications of the embodiments herein shown and described will obviously occur to those skilled in the art upon becoming familiar with said underlying concept. It is to be understood, therefore, that the invention may be practiced otherwise than as specifically set forth in the appended claims.