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1. WO2016153476 - MEDICINAL VIAL STOPPER

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[ EN ]

CLAIMS

We claim:

1. 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 circumscribing the open end and having a generally annular shape, the spike comprising a shaft having a radially outwardly facing sidewall with a diameter Ds, a lumen within the shaft having at least one vent proximal to a tip of the shaft and through which the medicament may be drawn into the lumen, the vial stopper 100 comprising:

a stopper flange having a circular disk-like shape with a stopper-flange outer diameter Dp bisected by a stopper flange longitudinal axis "XL" and a flange thickness "T" in a direction parallel to the longitudinal axis XL, the stopper flange having a first side 1 , 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 extending from the second side of the stopper flange, the stopper plug having a circular cylindrical shape with a plug outer diameter D bisected by the flange longitudinal axis XL and less than the stopper-flange outer diameter Dp, the stopper plug sealingly insertable with a compression fit in the neck of the via;

a first bore within the stopper plug, the first bore having a first-bore first end and a first-bore second en a first-bore length from the first-bore first end, a radially inwardly facing first-bore surface having a constant first-bore diameter DBi the entire first-bore length, the first-bore first closed by the centrally- located piercable portion of the stopper flange;

a second bore within the stopper plug, the second bore having a second-bore first end and a second-bore second en a second-bore length from the second-bore first end, a radially inwardly facing second-bore surface having a constant second-bore diameter D]¾ the entire second-bore length, the second-bore diameter Di¾ greater than the first-bore diameter DBI, the second-bore first end in fluid communication with the first-bore second end,

wherein the centrally-located piercable portion of the stopper flange is rcsilicntly 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.

2. The vial stopper according to claim 1 , wherein radially inwardly facing first-bore surface is in sliding contact with the outer surface of the shaft after the spike has pierced the centrally-located piercable portion 108 of the stopper flange and is being inserted beyond the second end of the first bore.

3. The vial stopper according to claim 1 , wherein a volume of an annular space bounded by the radially inwardly facing first-bore surface and an portion of the outer surface of the shaft opposing the radially inwardly facing first-bore surface is more than about 0.01 milliliter and less than about 0.25 milliliter when the spike has pierced the centrally-located piercable portion of the stopper flange and is inserted beyond the second end of the first bore and the radially inwardly facing first-bore surface is spaced from the outer surface of the shaft.

4. The vial stopper according to claim 1 , wherein a volume of an annular space bounded by the radially inwardly facing first-bore surface and an portion of the outer surface of the shaft opposing the radially inwardly facing first-bore surface is more than about 0.01 milliliter and less than about 0.14 milliliter when the spike has pierced the centrally-located piercable portion of the stopper flange and extends beyond the second end of the first bore and the radially inwardly facing first-bore surface is spaced from the outer surface of the shaft.

5. The vial stopper according to claim 1 , wherein a transition bore is between the first bore and the second bore, the bore transition being an annular surface lying entirely in a plane perpendicular to the longitudinal axis of the stopper flange and having a transition-bore inner diameter equal to the first-bore diameter DB I and a transition-bore outer diameter equal to the second-bore diameter DB2-

6. The vial stopper according to claim 1 , wherein a transition bore is between the first bore and the second bore, the bore transition having a transition-bore first end and a transition-bore second end a transition-bore length from the transition-bore first end, the transition-bore first end having a transition-bore first-end diameter equal to the first-bore diameter DBI, the transition-bore second end having a transition-bore second-end diameter equal to the second-bore diameter DB2, and a radially inwardly facing transition-bore surface has a shape corresponding to an inner surface of a truncated frustum of a hollow cone.

7. The vial stopper according to claim 1 , wherein the bore has a transition bore between the first bore and the second bore, the bore transition having a transition-bore first end 124a and a transition-bore second end 124b a transition-bore length from the transition-bore first end 124a, the transition-bore first end 124a having a transition-bore first-end diameter equal to the first-bore diameter DBI , the transition-bore second end 124b having a transition-bore second-end diameter equal to the second-bore diameter DB2, and a radially inwardly facing transition-bore surface 126 has an arcuate shape.

8. The vial stopper according to claim 1 , wherein the fluid impenetrable seal 120 comprises ruptured edges of the centrally-located piercabie portion 108 of the stopper flange 102 formed when the centrally- located piercabie portion 108 of the stopper flange 102 is pierced by the spike 20.

9. The vial stopper according to claim .1 , wherein the stopper is a lyophilization stopper.

10. A vial 10 containing a medicament withdrawable from the vial by a spike 20 able to pierce the vial stopper 100 according to claim 1 sealing an open end 12a of a neck 12 of the vial