Vial transferset and method
First Claim
1. A fluid transfer assembly for establishing fluid communication between a syringe or the like and a sealed vial, said vial having an open end, a rim surrounding said open end, a reduced diameter neck portion adjacent said rim and a pierceable stopper received in and sealing said vial open end, said stopper having a rim portion received over said vial rim, said transfer assembly comprising:
- a tubular transfer member having an open proximate end sealingly supported on said stopper rim portion in alignment with said vial open end and an open distal end adapted to receive a syringe tip in sealed communication;
a piercing member received within said tubular transfer member reciprocally supported by an internal surface of said transfer member, said piercing member having a piercing end opposite said stopper rim portion adapted to pierce said stopper and an opposed distal end;
a cap having a proximate radial rim portion adjacent an open end, a tubular portion surrounding said tubular transfer member and a closed distal end enclosing said open distal end of said transfer member and said distal end of said piercing member; and
a collar having a radial portion received over said cap radial rim portion, a tubular portion surrounding said cap radial rim portion and said vial rim and a distal radial portion received in said vial neck portion of said vial beneath said vial rim permanently securing said transfer assembly to said vial.
2 Assignments
0 Petitions
Accused Products
Abstract
The improved vial transfer assembly or vial transferset may be attached to a vial under sterile conditions and used to transfer fluid to or from a conventional vial. The transferset includes a tubular transfer member which is sealingly supported on the rim portion of a vial stopper, a piercing member having a piercing end reciprocally supported by an internal surface of the transfer member, a cap enclosing the tubular transfer member and a collar preferably formed of a malleable material which secures the assembly on the stopper, which is crimped beneath the vial rim. The piercing member has a generally longitudinal external channel which, upon piercing the planar portion of the stopper, establishes fluid communication with the vial through the tubular transfer member. The distal end of the tubular transfer member includes a Luer lock for establishing fluid communication to a syringe, IV set or the like. An annular lip on the proximate end of the tubular transfer member stretches and prestresses the central portion of the planar stopper rim and the piercing member is supported in the transferset such that the piercing end deforms the prestressed stopper rim portion.
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Citations
41 Claims
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1. A fluid transfer assembly for establishing fluid communication between a syringe or the like and a sealed vial, said vial having an open end, a rim surrounding said open end, a reduced diameter neck portion adjacent said rim and a pierceable stopper received in and sealing said vial open end, said stopper having a rim portion received over said vial rim, said transfer assembly comprising:
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a tubular transfer member having an open proximate end sealingly supported on said stopper rim portion in alignment with said vial open end and an open distal end adapted to receive a syringe tip in sealed communication; a piercing member received within said tubular transfer member reciprocally supported by an internal surface of said transfer member, said piercing member having a piercing end opposite said stopper rim portion adapted to pierce said stopper and an opposed distal end; a cap having a proximate radial rim portion adjacent an open end, a tubular portion surrounding said tubular transfer member and a closed distal end enclosing said open distal end of said transfer member and said distal end of said piercing member; and a collar having a radial portion received over said cap radial rim portion, a tubular portion surrounding said cap radial rim portion and said vial rim and a distal radial portion received in said vial neck portion of said vial beneath said vial rim permanently securing said transfer assembly to said vial. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. A fluid transfer assembly for establishing fluid communication between a syringe and a sealed vial, said vial having an open end, a rim surrounding said open end, a reduced diameter neck adjacent said rim, and a pierceable stopper received in and sealing said vial open end, said stopper having a rim portion received over said vial rim, said transfer assembly comprising:
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a generally tubular transfer member having an open proximate end sealingly supported on said stopper rim in generally coaxial alignment with said vial open end and an open distal end adapted to receive a syringe in sealed communication; a piercing member received within said tubular transfer member reciprocally supported by an internal surface of said transfer member, said piercing member having a relatively sharp piercing end deforming said stopper radial rim portion and an external channel providing communication between said vial and said tubular transfer member when said piercing member penetrates said stopper; a cup-shaped cap having a tubular portion surrounding said transfer member and a removable cover portion enclosing said open distal end of said transfer member and said distal end of said piercing member; and a collar having a radial portion received over said cap radial rim portion, a tubular portion surrounding said cap radial rim portion and said vial rim and a distal radial portion received in said vial neck portion beneath said vial rim permanently securing said transfer assembly to said vial. - View Dependent Claims (15, 16, 17, 18, 19, 20)
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21. A method of transferring fluid medicament between a conventional sealed vial and a second container, said vial having an open end, a rim surrounding said open end, a reduced diameter neck adjacent said rim and a pierceable stopper received in and sealing said vial open end, said stopper having a rim portion received over said vial rim, said second container including a tubular connector portion, said method comprising:
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mounting a fluid transfer assembly on said vial, said transfer assembly including a tubular transfer member having an open proximate end adapted to be sealingly supported on said stopper rim of said vial in alignment with said vial open end and an open distal end having a connector adapted to be connected to said connector portion of said second container, a piercing member received in said tubular transfer member reciprocally supported by an internal surface of said tubular transfer member, said piercing member having a generally short piercing end and an external channel, and a tubular collar, said method including mounting said fluid transfer assembly on said vial by securing said collar on said neck portion of said vial beneath said rim with said tubular transfer member sealingly engaging said stopper rim portion and said piercing member coaxially aligned with said vial open end and said piercing end adjacent said stopper; attaching said connector portion of said second container to said connector on said tubular transfer member, driving said piercing member generally sharp piercing end through said stopper rim portion, said external channel in said piercing member establishing fluid communication between said vial and said second container through said tubular transfer member, thereby permitting transfer of fluid from said second container to said vial or from said vial to said second container. - View Dependent Claims (22, 23, 24, 25, 26, 27, 28, 29, 30, 31)
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32. A method of assembling a fluid transfer assembly on a conventional vial for transferring fluid between said vial and a second container, said vial having an open end, a rim surrounding said open end, a reduced diameter neck adjacent said rim, and a resilient pierceable stopper received in and sealing said vial open end, said stopper having a rim portion received over said vial rim, said method comprising:
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inserting an elongated piercing member having a piercing end and an opposed distal end into a tubular fluid transfer member having an internal surface supporting said piercing member for telescopic movement in said tubular fluid transfer member, said tubular fluid transfer member including an open proximate end adjacent said piercing end of said piercing member having a projecting sealing lip and an open distal end; inserting said tubular fluid transfer member into a cup-shaped cap, said cup-shaped cap including an open proximate end which receives said tubular fluid transfer member and said piercing member, a radial rim portion adjacent said open proximate end and a closed distal end adjacent said distal ends of said tubular fluid transfer member and said piercing member; and securing said fluid transfer assembly on said vial rim with a collar by locating said cap, tubular fluid transfer member and piercing member on said rim portion of said stopper with said tubular fluid transfer member and piercing member generally coaxially aligned with said vial opening, said collar having a radially inwardly projecting portion overlying said rim portion of said cap, a tubular portion surrounding said radial portion of said cap and said vial rim and a radial portion received in said vial neck beneath said rim and simultaneously compressing said sealing lip of said tubular fluid transfer member against said rim portion of said stopper, stretching said stopper rim portion over said vial opening and sealing communication between said tubular fluid transfer member and said vial opening when said piercing end of said piercing member pierces said stopper. - View Dependent Claims (33, 34, 35, 36, 37)
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38. A method of securing a fluid transfer assembly on a conventional vial and stopper assembly, said vial having an open end, a radial rim portion surrounding said open end and a reduced diameter neck portion adjacent said open end, said stopper formed of an elastomeric material and including a tubular portion received in said vial open end and an integral generally planar rim portion overlying said vial rim portion, said method comprising:
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assembling said fluid transfer assembly on said stopper generally planar rim portion, said fluid transfer assembly including a generally flat annular surface overlying said planar rim portion of said stopper having a circular sealing lip projecting from generally flat annular surface; securing said fluid transfer assembly on said vial stopper assembly with a collar formed of a malleable metal, said collar including a tubular portion having an inside diameter slightly greater than an outside diameter of said vial rim portion and an integral radially inwardly projecting annular portion, said method including disposing said collar tubular portion over said fluid transfer assembly and said vial rim portion with said collar radially inwardly projecting annular portion receiving said generally flat annular surface of said fluid transfer assembly, compressing said circular sealing lip projecting from said flat annular surface into said stopper generally planar rim portion and crimping a distal end of said collar tubular portion into said vial neck beneath said vial rim. - View Dependent Claims (39, 40, 41)
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Specification