Patent Publication Number: US-2018044076-A1

Title: Medicinal vial stopper

Description:
BACKGROUND OF THE INVENTION 
     The present invention relates to stoppers for medicinal vessels. More particularly, the present invention relates to a medicinal vial stopper which can be penetrated by a puncturing device, for example a syringe needle or vial adapter, and is self-closing upon withdrawal of the puncturing device. 
     Drugs intended for parenteral administration can be stored in a medicinal vial as a dry powder which requires reconstitution in the vial with a physiological solution, such as a sterile solution of sodium chloride that is isotonic to body fluids, prior to withdrawal of the reconstituted drug from the vial. Solutions which are ready for immediate use or in the form of a liquid concentrate which requires reconstitution are also stored in medicinal vials. Regardless of the manner in which a drug is stored, there is a need to transfer the liquid from of the drug in a medicinal vial to a dispensing device. 
     Referring to  FIG. 1 , an inverted portion of a typical medicinal vial  10  from which a medicament has been withdrawn is shown. The vial  10  has a neck  12  with an open end  12   a  circumscribed by a neck flange  14  having a generally annular shape. 
     A conventional stopper  20  having a stopper flange  22  from which a stopper plug  24  extends is sealingly inserted in the neck  12  of the medicinal vial  10 . The stopper plug  24  has a generally cylindrical-shape cavity (or headspace)  26  with one end closed by the centrally located piercable portion of the stopper flange  22  and the other end in open fluid communication with the contents of the vial  10 . 
     A vial adapter  30  having a top wall  32  from which a generally cylindrical skirt  34  extends is attached to the vial  10  by a neck grip  36  which extends radially inwardly from the skirt  34  and engages the flange  14  of the bottle in a snap fit. A hub  38  attachable to a syringe barrel (not shown) extends from one side of the top wall  32 . A spike  40  extends from the other side of the top wall  32 . The spike  40  has a shaft  42  which pierces a central portion of the stopper flange  22 . The shaft  42  has a radially outwardly facing sidewall  44 . A lumen  46  within the shaft  42  is in fluid communication with the hub  38  and has at least one vent  48  proximal the tip  50  of the shaft  42  through which the medicament may be drawn into the lumen  44 . A ride-up  28  of the stopper flange  22  extends along a portion of the sidewall  44  of the shaft  42  after the shaft  42  has pierced the stopper flange  22 . 
     In conventional practice, the medicament is withdrawn from the vial by inverting the vial as shown in  FIG. 1  after the stopper flange  22  has been pierced and the shaft  42  inserted into the vial  10  until the vent  48  is past the ride-up  28  and the medicament can be withdrawn by a dispending device (not shown) attachable to the hub  38 . Due to the ride-up  28  and the diameter of the closed end of the headspace  26 , the medicament is usually not completely withdrawn from the vial  10 . For example, for a conventional  13  millimeter-size stopper, the residual amount of medicament remaining in the vial is typically 0.14 milliliters; for a conventional 20 millimeter-size stopper , the residual amount of medicament remaining in the vial is typically 0.25 milliliters. 
     Accordingly, in view of the ever increasing cost of medicament, there is a need in the art for a medicinal vial stopper which reduces the residual amount of medicament that can not be withdrawn from a vial. 
     BRIEF SUMMARY OF THE INVENTION 
     Briefly stated, one embodiment of the present invention is directed to a vial stopper for sealing an open end of a neck of a vial containing a medicament withdrawable from the vial by a spike able to pierce the stopper. A neck flange circumscribes the open end of the vial and has a generally annular shape. The spike comprises a shaft having a radially outwardly facing sidewall with a diameter. A lumen within the shaft has at least one vent proximal to a tip of the shaft through which the medicament may be drawn into the lumen. 
     The vial stopper comprises a stopper flange having a circular disk-like shape with a stopper-flange outer diameter bisected by a stopper flange longitudinal axis and a flange thickness in a direction parallel to the longitudinal axis. The stopper flange has a first side, a second side spaced the flange thickness from the first side and a centrally-located stopper-flange portion piercable by the spike. 
     A stopper plug extends from the second side of the stopper flange. The stopper plug has a circular cylindrical shape with a plug outer diameter bisected by the flange longitudinal axis and less than the stopper-flange outer diameter. The stopper plug is insertable with a compression fit in the neck of the vial. 
     A first bore is within the stopper plug. The first bore has a first-bore first end and a first-bore second end a first-bore length from the first-bore first end. A radially inwardly facing first-bore surface has a constant first-bore diameter the entire first-bore length. The first-bore first end is closed by the centrally-located piercable portion of the stopper flange. 
     A second bore is within the stopper plug. The second bore has a second-bore first end and a second-bore second end a second-bore length from the second-bore first end. A radially inwardly facing second-bore surface has a constant second-bore diameter the entire second-bore length. The second-bore diameter is greater than the first-bore diameter. The second-bore first end is in fluid communication with the first-bore second end. 
     The centrally-located piercable portion of the stopper flange is resiliently deformable and upon being pierced by the spike tightly conforms to the radially outwardly facing sidewall of the shaft; thereby forming a fluid impenetrable seal. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
       The foregoing summary, as well as the following detailed description of preferred embodiments of the invention, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, the drawings show embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown. 
       In the drawings: 
         FIG. 1  is a cross sectional view of a portion of an inverted vial sealed by a prior art stopper penetrated by a conventional vial adapter; 
         FIG. 2  is a cross sectional view of a first preferred embodiment of vial stopper in accordance with the present invention spaced from a cross sectional view of a portion of the spike of the vial adapter of  FIG. 1 ; 
         FIG. 3  is a cross sectional view of a portion of an inverted vial sealed by the stopper penetrated of  FIG. 2  penetrated by the conventional vial adapter of  FIG. 1 ; and 
         FIG. 4  is an enlarged portion of  FIG. 3  showing the ride-up of the stopper flange extends along a portion of the sidewall of the shaft after the shaft has pierced the stopper flange. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Reference will now he made in detail to embodiments of the invention, examples of which are illustrated in the accompanying drawings. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. 
     As used in the description of the invention and the appended claims, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. The words “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. 
     Although the words first, second, etc., are used herein to describe various elements, these elements should not be limited by these words. These words are only used to distinguish one element from another. For example, a first bore could be termed a second bore, and, similarly, a second bore could be termed a first bore, without departing from the scope of the present invention. 
     The following description is directed towards various embodiments of a medicinal stopper vial in accordance with the present invention. 
     Referring to the drawings in detail, where like numerals indicate like elements throughout, there is shown in  FIGS. 2-4  a first preferred embodiment of the medicinal vial stopper, generally designated  100 , and hereinafter referred to as the “vial stopper”  100  in accordance with the present invention. The vial stopper  100  is for sealing an open end  12   a  of a neck  12  of a vial  10  containing a medicament withdrawable from the vial by a spike  40  able to pierce the stopper. A neck flange  14  circumscribes the open end  12   a  of the vial  10  and has a generally annular shape. The spike  40  comprises a shaft  42  having a radially outwardly facing sidewall  44  with a diameter D S . A lumen  46  within the shaft  42  has at least one vent  48  proximal to a tip  50  of the shaft  42 . The medicament may be drawn into the lumen  46  through the vent  48 . 
     The vent stopper  100  comprises a stopper flange  102  having a circular disk-like shape with a stopper-flange outer diameter D F  bisected by a stopper flange longitudinal axis “X L ” and a flange thickness “T” in a direction parallel to the longitudinal axis X L . The stopper flange  102  has a first side  104 , a second side  106  spaced the flange thickness “T” from the first side  104  and a centrally-located stopper-flange portion  108  piercable by the spike  40 ; 
     A stopper plug  110  extends from the second side  106  of the stopper flange  102 . The stopper plug  110  has a circular cylindrical shape with a plug outer diameter D P  bisected by the flange longitudinal axis X L  and less than the stopper-flange outer diameter D F . The stopper plug  110  is sealingly insertable with a compression fit in the neck  12  of the vial  10 . 
     A first bore  112  is within the stopper plug  110 . The first bore  112  has a first-bore first end  112   a  and a first-bore second end  112   b  a first-bore length L B1  from the first-bore first end  112   a . A radially inwardly facing first-bore surface  114  has a constant first-bore diameter D B1  the entire first-bore length L B1 . The first-bore first end  112   a  is closed by the centrally-located piercable portion  108  of the stopper flange  102 . 
     In some embodiments of the vial stopper  100 , the radially inwardly facing first-bore surface  114  of the first bore  112  is in sliding contact with the outer surface  44  of the shaft  42  after the spike  40  has pierced the centrally-located piercable portion  108  of the stopper flange  102  and is being inserted beyond the second end  112   b  of the first bore  112 . 
     In other embodiments, a volume of an annular space  122  bounded by the radially inwardly facing first-bore surface  114  and a portion of the outer surface  44  of the shaft  42  opposing the radially inwardly facing first-bore surface  114  is desirably more than about 0.01 milliliter and less than about 0.25 milliliter and preferably less than about 0.20 milliliter when the spike  40  has pierced the centrally-located piercable portion  108  of the stopper flange  102  and is inserted beyond the second end  112   b  of the first bore  112  and the radially inwardly facing first-bore surface  114  is spaced from the outer surface of the shaft  42 . 
     In still other embodiments of the vial stopper  100 , the volume of an annular space  122  bounded by the radially inwardly facing first-bore surface  11 . 4  and a portion of the outer surface  44  of the shaft  42  opposing the radially inwardly facing first-bore surface  114  is desirably more than about 0.01 milliliter and less than about 0.14 milliliter and preferably less than about 0.10 milliliters when the spike  40  has pierced the centrally-located piercable portion  108  of the stopper flange  102  and is inserted beyond the second end  112   b  of the first bore  112  and the radially inwardly facing first-bore surface  114  is spaced from the outer surface of the shaft  42 . 
     A second bore  116  is within the stopper plug  110 . The second bore  116  has a second-bore first end  116   a  and a second-bore second end  116   b  a second-bore length L B2  from the second-bore first end  116   a.  A radially inwardly facing second-bore surface  118  has a constant second-bore diameter D B2  the entire second-bore length L B2 . The second-bore diameter D B2  is greater than the first-bore diameter D B1  The second-bore first end  116   a  is in fluid communication with the first-bore second end. 
     The centrally-located piercable portion  108  of the stopper flange  102  is resiliently deformable and upon being pierced by the spike  40  tightly conforms to the radially outwardly facing sidewall  44  of the shaft  42 , thereby forming a fluid impenetrable seal  120 . In some embodiments, the fluid impenetrable seal  120  has a run-up  120   a  comprising edges of the centrally-located piercable portion  108  of the stopper flange  102  formed when the centrally-located piercable portion  108  of the stopper flange  102  is pierced by the spike  40  and extending along the outwardly facing side wall of the shaft  42  as shown in  FIG. 4 . 
     Preferably, the vial stopper  100  has a transition bore  124  between the first bore  112  and the second bore  116 . 
     In some embodiments of the vial stopper  100  has a transition bore  124  having a transition-bore first end  124   a  and a transition-bore second end  124   b  a transition-bore length L BT  from the transition-bore first end  124   a  between the first bore  112  and the second bore  116 . The transition-bore first end  124   a  has a transition-bore first-end diameter equal to the first-bore diameter D BI . The transition-bore second end  124   b  having a transition-bore second-end diameter equal to the second-bore diameter D B2 . The transition bore  124  has a radially inwardly facing transition-bore surface  126  having an arcuate shape. Alternatively, the radially inwardly facing transition-bore surface  126  may have a shape corresponding to an inner surface of a truncated frustum of a hollow cone. 
     In a preferred embodiment of the vial stopper  100 , the transition bore  124  comprises an annular surface  126  lying entirely in a plane perpendicular to the longitudinal axis X L  of the stopper flange  102  and has a transition-bore inner diameter equal to the first-bore diameter D B1  and a transition-bore outer diameter equal to the second-bore diameter D B2 . 
     The foregoing detailed description of the invention has been disclosed with reference to specific embodiments. However, the disclosure is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Those skilled in the art will appreciate that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. Therefore, the disclosure is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.