Syringe tip cap assembly, syringe comprising such a syringe tip cap and method of sealing a syringe barrel

Abstract

A syringe tip cap is provided for retaining a resilient closure at a distal end of a syringe tip of a syringe barrel, comprising a distal cap and a proximal sleeve connected via a coupling strip. An annular first breaking line is formed between the distal cap and the proximal sleeve. Frangible portions are provided as tamper indicator means. The proximal sleeve comprises a second breaking line extending nearly perpendicular to the first breaking line. For opening the cap, first the annular first breaking line is broken so the distal cap and the proximal sleeve can be partially separated. Thereby, the coupling strip serves as a hinge for pivotally coupling the distal cap and the proximal sleeve. Afterwards, the user further pulls down the distal cap in axial direction for breaking the second breaking line. The user may tear-off the syringe tip cap to access to the resilient closure.

What is claimed is: 
     
         1 . A syringe tip cap for retaining a resilient closure at a distal end of a syringe tip on which a collar for coupling with a syringe needle is mounted, comprising:
 a rigid outer cap having a distal cap member and a proximal sleeve member, wherein an annular first breaking line is formed between the distal cap member and the proximal sleeve member; and   tamper indicator means comprising frangible portions which are broken when the annular first breaking line is broken; wherein   the distal cap member is cup-shaped for accommodating and covering a distal end of the resilient closure, and configured for pressing the resilient closure toward the syringe tip; and   the proximal sleeve member comprises a distal end and a proximal end configured to be coupled with the collar, for coupling the syringe tip cap with the distal end of the syringe tip; wherein   the proximal sleeve member comprises a second breaking line extending between the distal end and the proximal end of the proximal sleeve member;   the distal cap member and the proximal sleeve member of the rigid outer cap are connected with each other via an axial coupling strip, which bridges and disrupts the annular first breaking line; and   the frangible portions of the tamper indicator means are weaker than the coupling strip, so that   the distal cap member and the proximal sleeve member of the rigid outer cap can be partially separated by breaking the annular first breaking line and   
       the coupling strip serves as a hinge for pivotally coupling the distal cap member and the proximal sleeve member of the rigid outer cap after the annular first breaking line has been broken. 
     
     
         2 . The syringe tip cap as claimed in  claim 1 , wherein the second breaking line is followed by a first slot, which is formed in the distal cap member and forms a first edge of the axial coupling strip. 
     
     
         3 . The syringe tip cap as claimed in  claim 2 , wherein the axial coupling strip is further delimited by a second slot which is formed in the distal cap member and extends in parallel with the first slot, so that the axial coupling strip is rectangular and extends in axial direction of the syringe tip cap. 
     
     
         4 . The syringe tip cap as claimed in  claim 1 , wherein the second breaking line is slanted at an acute angle relative to the axial direction of the syringe tip cap, wherein the second breaking line comprises frangible portions extending substantially perpendicular to the axial direction of the syringe tip cap. 
     
     
         5 . The syringe tip cap as claimed in  claim 2 , further comprising a third breaking line, said second breaking line and said third breaking line comprising frangible portions which are broken when the second breaking line and third breaking line is broken. 
     
     
         6 . The syringe tip cap as claimed in  claim 5 , wherein the second breaking line and third breaking line preferably extend in parallel with each other. 
     
     
         7 . The syringe tip cap as claimed in  claim 1 , wherein the distal cap member comprises a step portion formed at a side wall of the distal cap member opposite to a position where the coupling strip bridges the second breaking line. 
     
     
         8 . The syringe tip cap as claimed in  claim 7 , wherein the step portion is formed by a vertical side wall extending in the axial direction of the syringe tip cap and a surface extending radially inward perpendicular to or slanted relative to the axial direction, so that by pushing the vertical side wall obliquely upward toward a distal end of the syringe tip cap the distal cap member can be separated from the proximal sleeve member of the rigid outer cap to thereby break the annular first breaking line and partially separate the proximal sleeve member from the rigid outer cap. 
     
     
         9 . The syringe tip cap as claimed in  claim 1 , wherein a pressing member protrudes from an inner surface of the distal cap member of the rigid outer cap at a center thereof, for pressing the resilient closure toward the syringe tip. 
     
     
         10 . The syringe tip cap as claimed in  claim 9 , wherein a transparent portion is provided in a side wall of the distal cap member so that a contact region between the pressing member and the resilient closure and/or an upper surface of the resilient closure is visible from outside the syringe tip cap. 
     
     
         11 . The syringe tip cap as claimed in  claim 1 , wherein a plurality of locking protrusions is formed on an inner side wall of the proximal end of the proximal sleeve member, which are configured for gripping behind an edge of the collar, for coupling the syringe tip cap with the distal end of the syringe tip. 
     
     
         12 . The syringe tip cap as claimed in  claim 11 , wherein the locking protrusions are formed at equiangular intervals along the inner side wall of the proximal end of the proximal sleeve member, said locking protrusions having slanted insertion surfaces so that the syringe tip cap can be pushed onto the syringe tip. 
     
     
         13 . The syringe tip cap as claimed in  claim 12 , wherein the diameter of a circle along which the plurality of locking protrusions is disposed is smaller than a maximum outer diameter of the distal end of the resilient closure to be accommodated in the cup-shaped distal cap member so that the resilient closure is retained in axial direction inside the cup-shaped distal cap member by the plurality of locking protrusions. 
     
     
         14 . The syringe tip cap as claimed in  claim 11 , wherein a plurality of ridges are formed on an inner surface of the proximal sleeve member, wherein the ridges are disposed at a distance to the locking protrusions and equiangular intervals along the inner surface of the proximal sleeve member and enclose a circle having a diameter, which is substantially equal to an outer diameter of the collar and/or of the syringe. 
     
     
         15 . The syringe tip cap as claimed in  claim 1 , further comprising a resilient closure, which is accommodated and axially retained in the cup-shaped distal cap member. 
     
     
         16 . A syringe tip cap for retaining a resilient closure at a distal end of a syringe tip on which a collar for coupling with a syringe needle is mounted, comprising:
 a rigid outer cap having a distal cap member and a proximal sleeve member and configured to be coupled with the collar, for coupling the syringe tip cap with the distal end of the syringe tip; and   tamper indicator means comprising frangible portions which are broken when the annular first breaking line is broken; wherein   the distal cap member is cup-shaped for accommodating and covering a distal end of the resilient closure,   an annular first breaking line is formed between the distal cap member and the proximal sleeve member of the rigid outer cap,   the proximal sleeve member comprises a second breaking line extending between a distal end and a proximal end of the proximal sleeve member,   the second breaking line extends under an acute angle or under an angle of 90 degrees relative to the first breaking line,   the second breaking line runs into the first breaking line at a point of intersection, and   the distal cap member and the proximal sleeve member of the rigid outer cap are connected with each other via an axial coupling strip, which bridges and disrupts the annular first breaking line at a position adjacent to the point of intersection   
     
     
         17 . A syringe comprising:
 a syringe barrel having a substance receiving chamber and a syringe tip projecting from a distal end of the syringe barrel with a fluid passage extending through said syringe tip;   a collar concentrically surrounding the syringe tip, for coupling with a syringe needle;   a resilient closure having opposed proximal and distal ends, said proximal end defining a tip engaging portion for sealingly engaging the syringe tip to seal a substance contained in the substance receiving chamber of the syringe barrel; and   a syringe tip cap mounted at the distal end of a syringe tip, which engages with the collar and retains the resilient closure at the distal end of the syringe tip, for sealing the syringe tip;   said syringe tip cap comprising:   a rigid outer cap having a distal cap member and a proximal sleeve member, wherein an annular first breaking line is formed between the distal cap member and the proximal sleeve member; and   tamper indicator means comprising frangible portions which are broken when the annular first breaking line is broken; wherein   the distal cap member is cup-shaped for accommodating and covering a distal end of the resilient closure, and configured for pressing the resilient closure toward the syringe tip; and   the proximal sleeve member comprises a distal end and a proximal end configured to be coupled with the collar, for coupling the syringe tip cap with the distal end of the syringe tip;   wherein the proximal sleeve member comprises a second breaking line extending between the distal end and the proximal end of the proximal sleeve member;   the distal cap member and the proximal sleeve member of the rigid outer cap are connected with each other via an axial coupling strip, which bridges and disrupts the annular first breaking line; and   the frangible portions of the tamper indicator means are weaker than the coupling strip, so that   the distal cap member and the proximal sleeve member of the rigid outer cap can be partially separated by breaking the annular first breaking line and   the coupling strip serves as a hinge for pivotally coupling the distal cap member and the proximal sleeve member of the rigid outer cap after the annular first breaking line has been broken.   
     
     
         18 . A method of sealing a syringe barrel for administering a liquid containing a pharmaceutical drug, comprising the steps of:
 providing the syringe barrel having a syringe tip at a distal end thereof on which a collar for coupling with a syringe needle is mounted;   sealing the syringe tip with a resilient closure;   providing a syringe tip cap; and   pushing the syringe tip cap in axial direction on the distal end of the syringe barrel until the proximal end of the syringe tip cap is coupled with the collar and the resilient closure is pressed on the distal end of the syringe tip, for sealing the syringe tip;   said syringe tip cap comprising:   a rigid outer cap having a distal cap member and a proximal sleeve member, wherein an annular first breaking line is formed between the distal cap member and the proximal sleeve member; and   tamper indicator means comprising frangible portions which are broken when the annular first breaking line is broken; wherein   the distal cap member is cup-shaped for accommodating and covering a distal end of the resilient closure, and configured for pressing the resilient closure toward the syringe tip; and   the proximal sleeve member comprises a distal end and a proximal end configured to be coupled with the collar, for coupling the syringe tip cap with the distal end of the syringe tip; wherein   the proximal sleeve member comprises a second breaking line extending between the distal end and the proximal end of the proximal sleeve member;   the distal cap member and the proximal sleeve member of the rigid outer cap are connected with each other via an axial coupling strip, which bridges and disrupts the annular first breaking line; and   the frangible portions of the tamper indicator means are weaker than the coupling strip, so that   the distal cap member and the proximal sleeve member of the rigid outer cap can be partially separated by breaking the annular first breaking line and   the coupling strip serves as a hinge for pivotally coupling the distal cap member and the proximal sleeve member of the rigid outer cap after the annular first breaking line has been broken.   
     
     
         19 . The method of sealing a syringe for administering a liquid containing a pharmaceutical drug as claimed in  claim 18 , wherein
 the steps of sealing the syringe tip with a resilient closure and providing a syringe tip cap further comprise:   inserting the resilient closure in the cup-shaped distal cap member so that the resilient closure is accommodated and axially retained in the cup-shaped distal cap member before pushing the syringe tip cap in axial direction on the distal end of the syringe barrel; and   wherein the syringe tip cap together with the resilient closure accommodated and axially retained in the cup-shaped distal cap member is pushed in axial direction on the distal end of the syringe barrel until the resilient closure seals the syringe tip, the proximal end of the syringe tip cap is coupled with the collar and the resilient closure is pressed on the distal end of the syringe tip, for sealing the syringe tip.