Abstract:
A radioactive vial is shielded within a cylindrical vial guard having a central throughbore for receiving the vial. A nuclear pharmacist opens a bottom end of the vial guard and transfers the vial from a shielded shipping container into the throughbore. When the vial is introduced into the throughbore, a septum formed in the vial faces down. The pharmacist closes the bottom end of the vial guard, inverts and opens the top end to expose the septum. A syringe barrel is locked into a throughbore formed in a syringe shield that includes a lead liner. The needle at the leading end of the barrel penetrates the septum and radioactive liquid is withdrawn from the vial into the barrel. The vial guard and syringe shield protect the pharmacist from radiation exposure during the vial opening process.

Description:
BACKGROUND OF THE INVENTION  
         [0001]    1. Field of the Invention  
           [0002]    This invention relates, generally, to means for handling radiation therapy drugs. More specifically, it relates to a vial guard and a syringe shield that are used with one another to shield a nuclear pharmacist from beta radiation during handling of radioactive vials.  
           [0003]    2. Description of the Prior Art  
           [0004]    Radioactive Yttrium is a radiation therapy drug in liquid form that is commonly packaged in a vial having a bottle-like shape. When delivered to a nuclear pharmacist, the vial is housed within a plastic tube and the plastic tube is shielded within a lead pig. The nuclear pharmacist removes the vial from the pig and employs a syringe to puncture a septum formed in the vial. The liquid is withdrawn into the barrel of the syringe for mixing and dosing. Accordingly, the syringe must also be shielded.  
           [0005]    The current techniques for shielding the vial after it has been removed from the pig and for shielding the syringe after entry of the radioactive liquid thereinto are inadequate to fully protect the pharmacist.  
           [0006]    In view of the prior art taken as a whole at the time the present invention was made, it was not obvious to those of ordinary skill in this art how the needed protection could be provided.  
         SUMMARY OF THE INVENTION  
         [0007]    The long-standing but heretofore unfulfilled need for a system that protects nuclear pharmacists from radiation during vial removal from a pig and during mixing and dosing of radioactive liquid in a syringe is now met by a new, useful, and non-obvious vial guard and syringe shield that are used in conjunction with one another.  
           [0008]    The novel vial guard includes a main housing having a longitudinal axis of symmetry. A longitudinally-extending throughbore is formed in the main housing. The throughbore shares a common longitudinal axis of symmetry with the cylindrical main housing. The throughbore is adapted to receive a vial that contains a radioactive liquid. A top closure means closes a top end of the throughbore and a bottom closure means closes a bottom end thereof. The main housing, top closure means, and bottom closure means are preferably made of a transparent plastic material that shields against radiation. The material has a thickness sufficient to adequately prevent travel of radiation therethrough when the radioactive vial is positioned within the throughbore.  
           [0009]    The vial guard, top closure means, and bottom closure means collectively form a cylindrical vial guard when the top closure means and the bottom closure means are in closed relation to the throughbore. The top closure means is swivelly mounted to a top wall of the main housing and the bottom closure means is swivelly mounted to a bottom wall of the main housing.  
           [0010]    A novel syringe shield is adapted for use with the novel vial guard. Together, the vial guard and syringe shield protect a nuclear pharmacist from radiation during a procedure for opening the vial. The syringe shield includes an outer tube, a center tube, and an inner tube. A thin lead radiation shield having a generally “C” shaped configuration is adhered to the exterior of the center tube. A radial bore is formed in all three tubes and said radial bore is internally threaded in the center tube. A thumbscrew is disposed in a collective radial bore when all three tubes are rotated such that the respective radial bores are in radial alignment with one another. A distal end of the thumbscrew extends into a hollow interior of the inner tube when the thumbscrew is fully advanced. The hollow interior of the inner tube is adapted to slidingly receive a barrel of a syringe. The barrel is locked into a preselected position when the thumbscrew is fully advanced. The inner tube is used with syringes having barrels of small diameter and is not used with syringes having barrels of larger diameter.  
           [0011]    The pharmacist transfers the vial from a shielded shipping container by inverting the vial guard so that its top end is supporting it and its bottom end is up. The bottom closure means of the vial guard is then opened and the vial is inserted into the vial guard with the septum end leading. The bottom closure means is then closed and the vial guard is re-inverted so that the top end is again up and the vial guard is supported by its bottom end. The septum formed in the vial is now facing upwardly. The barrel of a syringe is then locked into the syringe shield, the top closure means is opened, and the needle of the syringe pierces the septum of the vial. Withdrawal of the syringe plunger pulls the radioactive liquid into the shielded barrel. Mixing and dosing are performed while the radioactive liquid is in the barrel.  
           [0012]    In this way, the vial guard and syringe shield work with one another to protect the handler of the vial.  
           [0013]    An important object of this invention is to significantly advance the art of nuclear pharmacy by providing a vial guard that protects a nuclear pharmacist from radiation when a vial containing a radioactive material is removed from a shipping container.  
           [0014]    Another object is to protect the pharmacist during the withdrawal of a radioactive material from a vial into the barrel of a syringe and during mixing and dosing of the material within said barrel.  
           [0015]    The invention accordingly comprises the features of construction, combination of elements, and arrangement of parts that will be exemplified in the description set forth hereinafter, and the scope of the invention will be set forth in the claims. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0016]    For a fuller understanding of the nature and objects of the invention, reference is made to the following detailed description, taken in connection with the accompanying drawings, in which:  
         [0017]    [0017]FIG. 1 is a perspective view of a preferred embodiment of the novel vial guard depicting the top and bottom closure means in their respective closed positions;  
         [0018]    [0018]FIG. 1A is a perspective view like FIG. 1 but with the top and bottom closure means in their respective open positions;  
         [0019]    [0019]FIG. 1B is a perspective view of a vial of the type that holds a radioactive radiation therapy drug in liquid form;  
         [0020]    [0020]FIG. 2 is a perspective view of the novel syringe shield of this invention;  
         [0021]    [0021]FIG. 2A is an exploded view of said syringe shield;  
         [0022]    [0022]FIG. 3 is an exploded perspective view depicting the syringe shield and vial guard in alignment with one another; and  
         [0023]    [0023]FIG. 3A is a perspective view depicting the syringe shield and vial guard in direct contact with one another. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0024]    Referring now to FIGS. 1 and 1A, it will there be seen that an illustrative embodiment of the novel vial guard is denoted as a whole by the reference numeral  10 . Vial guard  10  has three primary parts: a main housing  12 , a top closure means  14 , and a bottom closure means  16 . Each of these three primary parts is formed of a plastic that is sufficiently thick to provide significant beta radiation shielding. Proper use of guard vial  10 , as disclosed herein, minimizes exposure to beta radiation. In a preferred embodiment, the plastic is a polycarbonate but other suitable materials may be used as well. Vial guard  10  is preferably formed of clear materials to facilitate visual verification of a liquid extraction process disclosed hereinafter.  
         [0025]    In the illustrated, preferred embodiment, vial guard  10  is of solid cylindrical construction. Other geometrical shapes are within the scope of this invention, but the preferred cylindrical shape minimizes materials while maximizing the distance between a radioactive vial housed by vial guard  10  and the nuclear pharmacist who is the most likely handler of the vial guard.  
         [0026]    A typical radioactive vial of the type housed within vial guard  10  is denoted in FIG. 1B by the reference numeral  18 . Yttrium 90, a radioactive liquid, is contained within a hollow interior of vial  18  and is denoted  20 . A septum  22  at the top or leading end of vial  18  is pierced at its center with a syringe in a manner hereinafter disclosed to extract the Yttrium 90 from vial  18 . Other vials may hold radiation therapy drugs other than Yttrium and such other vials are within the scope of this invention.  
         [0027]    The shipping container for vial  18  is typically a lead-lined shipping container known as a pig. Vial  18  is positioned in a plastic tube that is in turn housed within the pig.  
         [0028]    Returning now to FIGS. 1 and 1A, it will there be observed that a central throughbore  24  is formed in main body  12  to accommodate vial  18 . Central throughbore  24  has a longitudinal axis of symmetry that is coincident with the longitudinal axis of symmetry of vial guard  10 . A diameter-reducing step  26  is formed near a first end of bore  24  and divides said bore into a first part  28  having a diameter greater than that of second part  30 . First part  28  receives the main body of vial  18  and reduced-diameter second part  28  receives the neck thereof. Septum  22  is positioned at the leading end of the neck.  
         [0029]    Top closure means  14  is swivel-mounted to main housing  12 . More particularly, a countersunk throughbore  32  is formed in top closure means  14  near a peripheral edge thereof and a uniform diameter blind bore  34  is formed in main housing  12  in longitudinal alignment therewith. A socket head shoulder screw  36  or other suitable pivot means is positioned within said bores  32 ,  34  and serves as a pivot about which top closure means  14  swivels. Uniform diameter bore  34  is preferably internally threaded to engage the external threads of screw  36 .  
         [0030]    As depicted in FIG. 1A, top closure means  14  is disposed in its fully swiveled, fully open position. However, when top closure means  14  is closed, and when bottom closure means  16  is in its fully open position, vial  18  may be removed from the pig and inserted into central throughbore  24  with septum  22  in a leading position so that it faces bottom wall  46  of top closure means  14 . Bottom closure means  16  is then closed, top closure means  14  is opened, and the radioactive material in the vial is removed therefrom in a manner hereinafter described.  
         [0031]    Dimple  38  is formed in top wall  40  of main housing  12 , near a peripheral edge thereof. It serves to align and lock top closure means  14  into its fully closed position. More particularly, an internally threaded throughbore  42  is formed in top closure means  14  in diametrically spaced apart relation to countersunk bore  32 . An externally threaded ball plunger  44  is mounted within bore  42  such that a distal end thereof extends just slightly beyond the plane of bottom wall  46  of top closure means  14 . The distal end of ball plunger  44  is formed of a hard but resilient and flexible plastic that is compressed when it encounters top wall  40  as closure means  14  is swiveled about screw  36 . When cylindrical top closure means  14  is fully aligned with cylindrical main housing  12 , said distal end enters into dimple  38  under its inherent bias and holds said top closure means  14  in its fully closed position. A user can hear and feel the entry of the distal end of ball plunger  44  into dimple  38 . Dimple  38  is shallow so that top closure means  14  is easily swiveled back to its open position as needed.  
         [0032]    The construction of bottom closure means  16  and its swiveling and locking means is like that of top closure means  14 . More particularly, as depicted in FIGS. 1 and 1A, a countersunk throughbore  32   a  is formed in bottom closure means  16  near a peripheral edge thereof and a uniform diameter blind bore  34   a  is formed in main housing  12  in longitudinal alignment therewith. A socket head shoulder screw  36   a  or other suitable pivot means is positioned within said bores  32   a ,  34   a  and serves as a pivot about which bottom closure means  16  swivels. Uniform diameter bore  34   a  is preferably internally threaded to engage the external threads of screw  36   a.    
         [0033]    Dimple  38   a  is formed in bottom wall  40   a  of main housing  12 , near a peripheral edge thereof. It serves to align and lock bottom closure means  16  into its fully closed position. More particularly, an internally threaded throughbore  42   a  is formed in bottom closure means  16  in diametrically spaced apart relation to countersunk bore  32   a . An externally threaded ball plunger  44   a  is mounted within bore  42   a  such that a distal end thereof extends just slightly beyond the plane of bottom wall  46   a  of bottom closure means  16 . The distal end of ball plunger  44   a  is formed of a hard but resilient and flexible plastic that is compressed when it encounters bottom wall  40   a  as bottom closure means  16  is swiveled about screw  36   a . When cylindrical bottom closure means  16  is fully aligned with cylindrical main housing  12 , said distal end enters into dimple  38   a  under its inherent bias and holds said bottom closure means  16  in its fully closed position. A user can hear and feel the entry of the distal end of ball plunger  44   a  into dimple  38   a . Dimple  38   a  is shallow so that bottom closure means  16  is easily swiveled back to its open position as needed.  
         [0034]    When vial  18  is inserted into center throughbore  24 , septum  22  thereof faces bottom wall  46  of top closure means  14  as aforesaid. To access septum  22 , top closure means  14  is fully opened and a syringe is used to puncture septum  22  at its center and to withdraw the radioactive liquid therefrom. If a nuclear pharmacist were to draw the radioactive liquid  20  in vial  18  into the barrel of an unshielded syringe, the benefits of vial guard  10  would be lost because the pharmacist would be exposed to radiation emitting from the barrel of said syringe.  
         [0035]    Accordingly, syringe shield  50 , depicted in FIGS. 2 and 2A, is provided so that a nuclear pharmacist may draw radioactive liquid  20  from vial  18  while vial  18  remains within vial guard  10 .  
         [0036]    Syringe shield  50  includes a clear plastic outer tube  52 . The nuclear pharmacist grips outer tube  52  when syringe shield  50  is in use.  
         [0037]    A square guard means  54  of planar configuration is secured to a proximal end of syringe shield  50  in normal relation to a longitudinal axis of symmetry thereof. It provides enhanced shielding from radiation.  
         [0038]    A center tube  56  is positioned within the hollow interior of outer tube  52 . In a preferred embodiment, it has a radial thickness equal to or greater than the radial thickness of the walls of outer tube  52 , as indicated in FIGS. 2 and 2A.  
         [0039]    Radiation shield  58  is adhered to an exterior wall of center tube  56 . It has a “C” shape as best indicated in FIG. 2A. A longitudinally-extending space between ends  58   a ,  58   b  enables the nuclear pharmacist to observe the withdrawal of radioactive liquid  20  from vial  18  when the invention is used in a manner hereinafter described.  
         [0040]    A pair of nylon flat head screws denoted  59  and  60  secure square guard  54  to the proximal end of center tube  56 . Outer wall  62  of square guard  54  is countersunk at  59   a ,  60   a  so that the respective heads of screws  59  and  60  are recessed with respect to said outer wall when said screws are fully tightened. Center tube  56  is bored and internally threaded as at  61 ,  63  to receive said screws  59 ,  60 , respectively.  
         [0041]    A radially disposed thumbscrew  64  is screw-threadedly engaged with radial bore  66 a formed in outer tube  52  and internally threaded radial bore  66   b  in center tube  56 . When manually advanced, distal end  64   a  of thumbscrew  64  extends into the hollow interior of center tube  56  to act as a set screw locking means for a syringe, not shown, positioned within said hollow interior. More particularly, the hollow interior of center tube  56  has a diameter sufficient to receive a five (5) or ten (10) cc syringe therein. Square guard  54  is centrally apertured as at  68 , and the diameter of said aperture is substantially equal to the diameter of the hollow interior of center tube  56 . Said diameter is sufficient to receive said five (5) or ten (10) cc syringe therethrough. When the barrel of a syringe of that size is inserted from the thumbscrew end of main body  52  into the hollow interior of center tube  56 , advancing thumbscrew  64  locks said barrel (not shown) into position. The needle of the syringe extends beyond the plane of square guard  54 .  
         [0042]    A nuclear pharmacist uses syringe shield  50  by inserting the barrel of a five (5) or ten (10) cc syringe into the hollow interior of center tube  56  from the thumbscrew end thereof as aforesaid and advances thumbscrew  64  when the barrel is fully inserted. The barrel is now fully shielded by center tube  56 , lead radiation shield  58 , and by outer tube  52 . Top closure means  14  of vial guard  10  is opened to expose septum  22  of vial  18 . The nuclear pharmacist holds outer tube  52  of syringe shield  50  and guides the needle into central bore  24  of vial guard main housing  12 . The needle is inserted through septum  22  and radioactive liquid  20  is pulled into the barrel of the syringe by retracting the plunger of said syringe. Mixing and dosing procedures, compounding, or other work is performed on the radioactive liquid while it is in the barrel of the syringe.  
         [0043]    The longitudinally-extending space between lead radiation shield walls  58   a ,  58   b  permits the nuclear pharmacist to observe the withdrawal of liquid  20  into the barrel of the syringe. A white backing  57  (FIG. 2) is placed in overlying relation to the inner cylindrical wall of center tube  56  in diametrically opposed relation to the longitudinally-extending space to enhance visibility. The longitudinal extent of white backing  57  is substantially co-extent with the longitudinally-extending space.  
         [0044]    After radioactive liquid  20  has been withdrawn from vial  18 , top closure means  14  is closed if vial guard  10  is to be used as a temporary storage means for the empty vial. In most cases, the empty vial is transferred from vial guard  10  to the pig within which it arrived. This is accomplished by holding vial guard  10  so that vial  18  slides into said pig under the influence of gravity.  
         [0045]    Syringe shield  50  as just described may be employed to protect a nuclear pharmacist from beta radiation when a five (5) or ten (10) cc syringe is used.  
         [0046]    Inner tube  70  (FIGS. 2 and 2A) is slidingly inserted into the hollow interior of center tube  56  when a one (1) or three (3) cc syringe is to be used. Inner tube  70  reduces the diameter of said hollow interior and provides further radiation shielding when such a syringe is to be used. Radial bore  66   c  is formed in said inner tube and receives the distal end of thumbscrew  64  when said thumbscrew  64  is sufficiently advanced. Said thumbscrew thus holds inner tube  70  against movement in the hollow interior of center tube  56 . Moreover, when a one (1) or three (3) cc syringe has been positioned within the hollow interior of said inner tube, a further advance of thumbscrew  64  causes it to bear against the barrel of said syringe, thereby acting as a set screw to lock said barrel into position relative to the hollow interior of said inner tube. The one (1) or three (3) cc syringe is then used in the same way as the five (5) or ten (10) cc syringe.  
         [0047]    When inner tube  70  is removed, syringe shield  50  may be used as a vial guard for a two (2) ml vial. The vial is dropped septum-side first into the square guard  54  end of syringe shield  50  so that the septum rests on thumbscrew  64 . By slowly backing off the screw, the septum is exposed as the septum falls to where the screw engages a shoulder of the vial. The screw is then locked down on the vial with the septum exposed.  
         [0048]    In the embodiment of FIGS. 3 and 3A, top closure means  14  is removed from vial guard  10  so that square guard means  54  directly abuts top wall  40  of main body  12 . When said parts abut one another, as depicted in FIG. 3A, the needle (not shown) that projects beyond the plane of square guard means  54  extends through septum  22  of vial  18  and withdrawal of a plunger as mentioned above draws radioactive liquid  20  into the barrel of said undepicted syringe. Set screw  64  holds said barrel in place as aforesaid. In this way, vial guard  10  and syringe shield  50  work together to protect the nuclear pharmacist at each step of the process.  
         [0049]    Novel vial guard  10  and novel syringe shield  50  thus cooperate with one another to enable a nuclear pharmacist to handle a radioactive vial and to extract radioactive liquid from the vial into the barrel of a syringe without being exposed to beta radiation. This protects the health of the nuclear pharmacist and ultimately the health of the patients served by the nuclear pharmacist.  
         [0050]    It will thus be seen that the objects set forth above, and those made apparent from the preceding description, are efficiently attained. Since certain changes may be made in the above construction without departing from the scope of the invention, it is intended that all matters contained in the foregoing description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.  
         [0051]    It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described, and all statements of the scope of the invention that, as a matter of language, might be said to fall therebetween.  
         [0052]    Now that the invention has been described,