Abstract:
A spike assembly having an elongate spike defining a hollow cannula that is in fluid communication with the interior of a luer connection portion. The spike assembly provides needleless access to a stopper of a vial to facilitate injection and withdrawal of fluids via a syringe barrel selectively secured to the luer connection portion. The syringe can safely be removed from the spike assembly and then be directly attached to a luer compatible connector. The elongate spike may include a frangible tip portion that can break away from the spike assembly within a vial. The spike assembly may have a neck with a pair of gripping wing members. The spike assembly may have a feature that prevents rotation of the spike in the vial stopper, thereby allowing the syringe to be easily and safely disconnected from the spike assembly without having to grasp the spike assembly.

Description:
FIELD OF THE DISCLOSURE  
       [0001]    This application relates generally to devices for gaining access to the contents of vials and, more specifically, to spiked cannulae used to pierce an elastomeric stopper of a vial, and to the provision of a luer engaging member. 
       BACKGROUND  
       [0002]    In order to deliver the contents of a vial to an intravenous bag or administration set, medical professionals typically first have to puncture the stopper of the vial with a syringe needle disposed on the distal end of a barrel of a syringe, if the contents are lyophilized, then inject a diluent into the vial and reconstitute the contents, draw the contents of the vial up into the syringe barrel, withdraw the syringe needle from the vial stopper, and then re-cap or remove the needle. This procedure is time consuming, involves a number of steps prior to delivery of the vial contents to the intravenous bag or administration set, and exposes medical professionals to sharp syringe needles. While recapping appliances are known, there are still times when the syringe needle is exposed. 
         [0003]    Moreover, the introduction of luer compatible connectors on infusion administration sets and flexible bags or containers removes much of the need for a needle to provide fluid connection to these sets or bags. If the syringe is withdrawn from the vial with the attached needle, the needle must be removed prior to connection to these luer compatible connectors. 
         [0004]    It would be desirable to provide a system in which a vial stopper may be pierced in a manner that permits the luer end of a typical syringe barrel to be selectively placed into communication with the interior of the vial without the use of a sharp needle, so that, if necessary, a diluent may be injected to reconstitute the contents of the vial, the vial contents may be drawn into the syringe barrel, and the syringe may be disengaged from the vial with only an end configured as a male luer tip to eliminate needle sticks. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING  
         [0005]      FIG. 1  is a cross-sectional view of a connecting portion of a syringe barrel and a spike assembly with a luer connection and a frangible tip; 
           [0006]      FIG. 2  is a cross-sectional view of the connecting portion of the syringe barrel and the spike with luer connection and frangible tip of  FIG. 1 , with the frangible tip of the spike assembly received in a stopper of a vial; 
           [0007]      FIG. 3  is a cross-sectional view of the spike with luer connection and frangible tip of  FIG. 1 ; 
           [0008]      FIG. 4  is a cross-sectional view similar to  FIG. 2 , but showing the elongate spike inserted further into the vial stopper, beyond the frangible tip of the spike assembly; 
           [0009]      FIG. 5  is a cross-sectional view similar to  FIG. 4 , showing the frangible tip of the spike broken off from the remainder of the spike assembly with luer connection; 
           [0010]      FIG. 6  is a cross-sectional view similar to  FIG. 5 , showing remainder of the spike assembly, now with a male luer stem, withdrawn from the vial stopper, with the broken-off frangible tip portion remaining in the vial; 
           [0011]      FIG. 7  is a perspective view of a spike assembly of an alternate embodiment of the present disclosure; 
           [0012]      FIG. 8  is a front plan view of the spike assembly of  FIG. 7 ; 
           [0013]      FIG. 9  is a cross-sectional view of the spike assembly of  FIG. 7 , taken along lines  9 - 9  of  FIG. 7 ; 
           [0014]      FIG. 10  is a cross-sectional view of a connecting portion of the syringe barrel and the spike assembly of  FIG. 7 , with the elongate spike of the spike assembly received in a stopper of a vial; 
           [0015]      FIG. 11  is a perspective view of a spike assembly of a second alternate embodiment of the present disclosure; 
           [0016]      FIG. 12  is a perspective view of a spike assembly of a third alternate embodiment of the present disclosure; 
           [0017]      FIG. 13  is a plan view of a spike assembly of a fourth alternate embodiment of the present disclosure; 
           [0018]      FIG. 14  is a cross-section view of the spike assembly of  FIG. 13 ; and 
           [0019]      FIG. 15  is an enlarged cross-sectional view of a rotating luer lock collar of the spike assembly of  FIGS. 13 and 14 , illustrating the region identified by the broken line  15  in  FIG. 14 . 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0020]    In a first embodiment of the present disclosure, a spike assembly  10  is provided. The spike assembly  10  includes an elongate spike  12  having a frangible tip portion  14  and a luer connection portion  16  at a proximal end  18  thereof, extending coaxially with the elongate spike  12 . The spike assembly  10  defines a hollow cannula with an opening  20  at or adjacent a distal end  22 . 
         [0021]    The spike assembly  10  preferably includes an intermediate section  24  between the frangible tip portion  14  and the luer connection portion  16  including a plurality of axially-extending ribs  26  that extend from the luer connection portion  16  to a location along the intermediate section  24 . An axially-extending region of the intermediate section  24  extending from the axially-extending ribs  26  to the frangible tip portion  14  is referred to herein as a luer stem  28 . Preferably, the portion of the luer stem  28  extending proximally from the frangible tip portion  14  is dimensioned, upon removal of the frangible tip portion, to form a male luer configured to engage a standard female luer connection fitting (not shown). 
         [0022]    The luer connection portion  16  of the spike assembly  10  is selectively engageable by a luer fitting  30  at the distal end of a syringe barrel  32 . The spike assembly  10  preferably has a wall thickness in the luer stem  28  thicker than along the frangible tip portion  14 . At an intersection of the frangible tip portion  14  and the luer stem  28 , the spike assembly  10  includes an annular reduced-thickness channel  34 . The annular reduced-thickness channel  34  provides a weakened location of the spike assembly  10  at which the frangible tip portion  14  may be broken away from the remaining intermediate section  24  and luer connection portion  16 . The annular reduced-thickness channel  34  may be v-shaped in cross-section, with a first wall  36  along the luer stem  28  extending perpendicularly to the longitudinal axis of the elongate spike  12 , and a second wall  38 , along the frangible tip portion  14 , preferably forming a 45° angle with the first wall  36 , and an apex of the v-shaped annular reduced-thickness channel  34  being radially inwardly of the outer diameters of the luer stem  28  and the frangible tip portion  14 . 
         [0023]    In use, a sharp point  40  at the distal end  22  the spike assembly  10  is used to pierce a stopper  42  of a vial  44 . If the contents of the vial  44  are lyophilized, diluent within the syringe barrel  32  is injected into the vial and the contents are reconstituted. The liquid contents of the vial  44  may then be drawn into the syringe barrel  32  by pulling on a plunger (not shown) received in the syringe barrel  32 . The syringe barrel  32  may then be tilted to force the frangible tip portion  14  against an inner wall of the vial  44 , and additional force may then be applied to break the frangible tip portion  14  away from the intermediate section  24  of the spike assembly  10  along the annular reduced-thickness channel  34  to expose the luer stem portion  28 . The syringe barrel  32  may then be used to withdraw the remaining luer connection portion  16  and intermediate section  24  of the spike assembly  10  from the stopper  42  of the vial  44 . The luer stem  28  may now be utilized to directly access a female luer connector (not shown). Such female luer connectors may include luer activating valves or devices on such medical components such as infusion sets or containers, flexible or rigid. 
         [0024]    Turning to  FIGS. 7-10 , a spike assembly  50  of a first alternate embodiment of the present disclosure is illustrated. The spike assembly  50  includes an elongate spike  52 , a neck  54  that extends in a plane that is perpendicular to the longitudinal axis of the elongate spike  52 , and a luer connection portion  56  disposed on a face of the neck  54  opposite the elongate spike  52 . In other words, the elongate spike  52  extends perpendicularly from a first face  58  of the neck  54  of the spike assembly  50 , and the luer connection portion  56  extends from a second face  60  of the neck  54 , with the neck  54  defining an intermediate section of the spike assembly  50 . The elongate spike  52  defines a hollow cannula with a preferably slotted opening  62  at or near a distal end  64  of the spike assembly  50 . The hollow cannula defined by the elongate spike  52  is in fluid communication with an aperture  65  through the neck  54 , and with the interior  66  of the luer connection portion  56 . 
         [0025]    As in the previous embodiment, the luer connection portion  56  is selectively engageable by a luer fitting at the distal end of a syringe barrel, as shown in cross-section in  FIG. 10 . 
         [0026]    The neck  54  includes a first end  68  and a second end  70 , equally spaced from the longitudinal axis of the elongate spike  52  on opposite sides of the neck  54 . A first gripping wing member  72  is provided at the first end  68  of the neck  54 , and a second gripping wing member  74  is provided at the second end  70  of the neck  54 . Each of the first and second gripping wing members  72 ,  74  preferably curves parabolically outwardly, away from the opposing gripping wing member  74 ,  72 , with increasing distance from the neck  54 . The parabolic configurations of the first and second gripping wing members  72 ,  74  allow the wing members to accommodate a variety of sizes of vials and syringe barrels with diameters which may exceed the spacing between the first  68  and second end  70  of the neck. 
         [0027]    The gripping wing members  72 ,  74  serve several functions. One function is to protect the user&#39;s fingers from inadvertent contact with the sharp point of the elongate spike  52 . A second function is to preserve the sterility of a tip  33  of the syringe luer fitting  30 , and the luer connection portion  56  by shielding the users fingers from contact with these elements particularly during attachment and removal of the spike assembly  50  from the syringe. A further function is to allow the wings to be squeezed toward each other as shown particularly in  FIG. 10  to provide selective gripping of the top rim of the vial  44  of various sizes. Such gripping engagement facilitates the injection and withdrawal process of fluid into and out of the vial  44  and also allows the spike assembly  50  to be selectively disengaged from the syringe while being embedded in the vial. 
         [0028]    The gripping wing members  72 ,  74  may each be provided with a plurality of ridges  76  on the exterior surface  78 ,  80  thereof. The ridges  76  enhance gripping the spike assembly  50  to facilitate insertion of the elongate spike  52  into the stopper of a vial, inasmuch as the fingers of the user may be covered by latex or non-latex medical gloves. The gripping wing members  72 ,  74  may also be used to hold the spike assembly while attaching and/or removing the syringe. 
         [0029]    In use, the user withdraws the spike assembly  50  from sterile packaging not shown by gripping the wing members  72 ,  74 . The user then engages the spike assembly  50  to the syringe by interconnection of luer connection portion  56  to the male luer tip of the syringe while maintaining the grip of the wing members  72 ,  74 . The user then engages the interconnected syringe and spike assembly  50  to a vial pushing the elongate spike  52  into the elastomeric stopper of the vial thereby penetrating the vial stopper. The gripping wings  72 ,  74  may be squeezed to thereby engage the vial. The user may then inject a diluent into the vial if necessary to reconstitute a solid drug and then remove the liquid contents of the vial into the syringe. The user may then twistingly disengage the assembly  50  from the syringe while keeping the elongage spike  52  safely shielded in the interior of the vial. Such disengagement also exposes the luer tip of the syringe which may now be used to form a connection with a female luer connector. 
         [0030]    In an embodiment, the gripping wings  72 ,  74  do not form inwardly extending latching projections opposite the tip  62  which may be utilized to grip beneath the top rim of a vial. These latches may create difficulty in accepting vials having a top rim with a diameter greater than the distance between the inward tips of these latches. 
         [0031]      FIG. 11  illustrates a second alternate embodiment of a spike assembly  90  of the present disclosure. Like the spike assembly  50  of the previous embodiment, the spike assembly  90  includes an elongate spike  92  extending from a first face  94  of a neck  96 , and a luer connection portion  98  extending from a second face  100  of the neck  96 . The elongate spike  92  defines a hollow cannula having a preferably slotted opening  102  at the distal end  104  thereof. The neck  96  has a first end  106  and a second end  108 . In the spike assembly  90  of this embodiment, gripping wing members  110 ,  112  are provided at each of the first and second ends  106 ,  108  of the neck  96 , and the gripping wing members  110 ,  112  preferably curve away from one another with increasing distance from the plane of the neck  96 . However, the gripping wing members  110 ,  112  only extend from the neck  96  in the direction of the luer connection portion  98 . Like spike assembly  90 , the gripping wing members  110 ,  112  serve to prevent the user&#39;s fingers from inadvertent contact with the luer connection portion  98  and the tip  33  of the syringe luer fitting  30 . 
         [0032]    A pointed tang  114  extends from the first face  94  of the neck  96 , in the same direction as the elongate spike  92 . The pointed tang  114  serves to provide a stabilizing second point of engagement of the spike assembly  90  with a vial stopper. This stabilizing second point of engagement is off-center, i.e. spaced from the longitudinal axis of the elongate spike  92 , to prevent rotation of the spike assembly  90  when the syringe is rotated counterclockwise to effect disengagement with the spike assembly. The user only needs to grip the vial and syringe, thereby avoiding contact with the spike assembly. 
         [0033]    In  FIG. 12 , a third alternate spike assembly  120  of the present disclosure is illustrated. This embodiment is similar to the spike assembly  90 , but the gripping wing members  122 ,  124  extend from a first face  126  of the neck  128 , in the direction of the elongate spike  130 , rather than from a second face  132 . Like the spike assembly  90 , the gripping wing members  122 ,  124  of the spike assembly  120  provide some protection to the user&#39;s fingers from the sharp tip  134  of the elongate spike  130 , as well as from the pointed tang  136 , which provides a stabilizing second point of engagement of the spike assembly  120  with a vial stopper. The size of gripping wing members  110 ,  112  may be limited by syringe size, whereas the size of griping wing members  122 ,  124  may be limited by vial size. Referring to  FIGS. 7 and 12 , it should be noted that the tang  136  may also be included on the spike assembly  50  by being formed on the neck  54  on one or both sides of the elongate spike  52 . 
         [0034]    Turning now to  FIGS. 13-15 , a fourth alternate spike assembly  140  of the present disclosure is similar to the spike assembly  10  of the first embodiment, but is provided with a rotating luer lock collar  142 . Along the intermediate section  144  of the spike assembly  140 , an annular frustoconical locking projection  146  is provided. The annular frustoconical locking projection  146  has a distal end  148  of a first diameter d 1 , and a proximal end  150  of a second, larger diameter d 2 . The intermediate section  144  of the spike assembly  140  preferably tapers inwardly from the distal end  148  of the annular frustoconical locking projection  144  to an annular reduced-thickness channel or stepped section  152  that provides a weakened portion of the spike assembly  140 , between the intermediate section  144  and the frangible tip portion  154 . 
         [0035]    The second diameter d 2  is at least slightly greater than the diameter of an axially-extending locking bore  156  provided at a proximal end  158  of the rotating luer lock collar  142 . The intermediate section  144  of the spike assembly  140  has a constant diameter d 3  between the distal end  148  of the annular frustoconical locking projection  146  and a neck portion  160  disposed between the intermediate section  144  and a luer connection portion  162  at a proximal end  164  of the spike assembly  140 . The diameter d 3  is less than the second diameter d 2  and at least slightly less than the diameter of the axially-extending locking bore  156  at the proximal end  158  of the rotating luer lock collar  142 . As a result, the rotating luer lock collar  142  is rotatably secured onto the intermediate section  144  of the spike assembly  140  by inserting the frangible tip portion  154  into the axially-extending locking bore  156  of the rotating luer lock collar  142 , pushing the axially-extending locking bore  156  of the rotating luer lock collar  142  over the annular frustoconical locking projection  146  until the axially-extending locking bore  156  passes the proximal end  150  of the annular frustoconical locking projection  148 . 
         [0036]    The luer connection portion  162  of the spike assembly  140  may be provided with one or more threads, such as male threads  166 , to provide threaded securement of a syringe barrel (not shown) with complementary female threads to the spike assembly  140 . The sidewall  168  of the rotating luer lock collar  142  defines an axially-extending cavity  170 . The cavity  170  may be provided with one or more threads, such as male threads  172 , to secure a female luer (not shown) within the cavity  170 . The ability to rotate the luer lock collar  142  facilitates selective securement of the male threads  172  within complementary female threads of such a female luer. 
         [0037]    An axially-extending bore  174  in the form of a hollow cannula extends substantially the entire length of the needle assembly  140 , from the luer connection portion  162  to an opening  176  at a distal end  178  of the spike assembly  140 . The spike assembly  140  terminates at a sharp tip  180  provided at the distal end  178 . 
         [0038]    While various embodiments have been described herein, it will be understood that variations can be made to the disclosed embodiments that are still within the scope of the following claims.