US20010025672A1 - Vial transferset and method - Google Patents

Abstract

This invention relates to an improved vial transfer assembly or vial transferset which 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.

Description

FIELD OF THE INVENTION
• This invention relates to an improved vial connector assembly or transferset, a method of affixing a transferset to a vial and a method of establishing fluid communication between a vial and syringe, IV set or the like which permits the use of a conventional or standard vial and syringe or the like to transfer fluid from a syringe to a vial or withdraw liquid medicament, for example, from a vial to a syringe. The improved transferset and method of this invention results in improved aspiration or reaspiration of a vial and improved sealing of the communication between a vial and a syringe.[0001]
BACKGROUND OF THE INVENTION
• It is now conventional to reduce certain drugs to a dry or powdered form to increase the shelf life of drugs and reduce inventory space. Such dry or powdered drugs are generally stored in a sealed vial and reconstituted into liquid form for administration to a patient by adding a diluent or solvent. A conventional vial includes an open end, a rim surrounding the open end and a reduced diameter neck portion adjacent the rim. The vial is conventionally sealed with an elastomeric stopper which includes a portion inserted into the neck of the vial and a planar rim portion which overlies the vial rim. The stopper is normally secured to the vial rim with an aluminum collar or cap. The aluminum collar includes a tubular portion which surrounds the rim portions of the stopper and vial, an inwardly projecting annular portion which overlies the rim portion of the stopper and a distal portion which is crimped into the vial neck beneath the vial rim portion. Because aluminum is malleable, the collar accommodates the buildup of tolerances of the dimensions of the stopper and vial rim. The dimensions and tolerances of standard vials and stoppers are set by the International Standards Organization (ISO).[0002]
• A powdered drug is generally reconstituted by inserting the needle of a syringe through the pierceable stopper on the vial and injecting a diluent, such as water, or a solvent into the vial. The reconstituted drug is then reaspirated from the vial with the same or a different syringe after mixing the diluent or solvent with the dry drug. As will be understood, this method exposes the healthcare worker to being pricked by the needle of the syringe and contamination of the needle or the drug.[0003]
• The prior art has therefore proposed various fluid or liquid transfer assemblies which may be secured to a vial under sterile conditions and which may then utilized to transfer liquid, such as a diluent or solvent, from a syringe to a vial and reconstituted medicament from the vial to a syringe which prevent contamination of the liquid medicament. In the most preferred embodiments, the assembly is protected from contamination by a cap or cover which is removed only prior to use. In the embodiments disclosed in the prior art, the transfer assembly includes a needle which pierces the stopper of the vial and the liquid is transferred through the needle lumen as disclosed, for example, in U.S. Pat. No. 5,429,256. In other embodiments, the conventional vial stopper is eliminated in favor of a fluid transfer assembly having a rubber stopper which is inserted into the neck of the vial without a planar rim portion. The stopper remains within the vial until such time as reconstitution of the drug is required. When the transfer assembly is actuated, the stopper is urged toward the interior of the vial to open the neck, thereby permitting fluid flow through the transfer assembly into the vial body. Examples of such embodiments include the MONOVIAL® line of drug delivery devices manufactured and sold by Becton Dickinson Pharmaceutical Systems of Le Pont de Claix, France and exemplified by U.S. Pat. No. 5,358,501. Although this embodiment is an excellent drug reconstitution system having superior properties, particularly convenience of use and maintenance of the sterile conditions of the drug in the vial, particularly where the vial is of a relatively large size, typically twelve milliliters or more, pharmaceutical companies have expressed an interest in an approach where the vial may also be a smaller size.[0004]
• The need therefore remains for a vial transferset which may be utilized with an ISO standard vial and stopper to transfer liquid from a conventional syringe to the vial or from a vial to a syringe after reconstituting a drug, for example, which is relatively simple in design and which reduces or eliminates contamination of the drug. It would also be desirable to eliminate the use of a conventional syringe needle to pierce the elastomeric stopper which seals the vial. As will be understood by those skilled in the art, a conventional syringe needle is thin and has an internal axial lumen or bore. The needle must therefore be withdrawn during aspiration of the vial or reaspiration where the medicament is reconstituted in the vial following delivery of a diluent or solvent to the vial. Where the needle is not substantially completely withdrawn during reaspiration of the vial, liquid medicament remains in the vial because the only liquid communication with the syringe is through the needle lumen. This may be a problem particularly where the vial is relatively small. For example, assuming a twenty millimeter long needle which pierces a two to three millimeter thick stopper, if the needle is pushed all the way through the stopper, there may be distance of as much as seventeen millimeters between the needle opening and the inner surface of the stopper. This amount below the needle lumen will not be reaspirated unless the needle is substantially withdrawn.[0005]
• The vial transferset and method of this invention solves these problems by providing a relatively simple and efficient fluid transfer assembly which may be affixed to an ISO standard vial which assures complete reaspiration of the vial and which does not require accurate positioning of the needle during reaspiration.[0006]
SUMMARY OF THE INVENTION
• The vial transferset or fluid transfer assembly of this invention is adapted to establish fluid communication between a syringe, intravenous (IV) device or the like and a sealed vial. As set forth above, the syringe and vial may be conventional and manufactured according to ISO standards. A conventional vial as presently used by the pharmaceutical companies includes an open end, a rim surrounding the open end and a reduced diameter neck portion adjacent the rim. The vial is sealed with a pierceable resilient stopper generally formed of an elastomeric material and most commonly includes a portion which is inserted into the neck of the vial and a planar rim portion which is received over the vial rim. The central portion of the planar rim portion which overlies the opening through the neck portion of the vial generally has a thickness of about two to three millimeters and the portion of the stopper which is received in the neck portion of the vial is generally tubular having an external diameter which is slightly greater than the internal diameter of the vial neck portion to assure a secure seal.[0007]
• The transferset or transfer assembly of this invention includes a generally tubular transfer member having an open proximate end which is sealingly supported on the stopper rim portion for example in general coaxial alignment with the vial open end and an opened distal end adapted to receive a syringe or the like in sealed communication. As used in this application, the proximate end of a component such as the tubular transfer member is the end closest to the planar rim portion of the stopper and the distal end is the end furthest from the rim portion of the stopper. As will be understood, these terms are used solely to simplify the explanation of the invention and are not intended to define structure.[0008]
• The transferset of this invention further includes a piercing member which is received within the tubular transfer member and reciprocally supported within the tubular transfer member by an internal surface of the tubular transfer member. The piercing member includes a relatively sharp preferably pointed piercing proximate end opposite the stopper rim portion adapted to pierce the stopper and an opposed distal end. As discussed more fully hereinbelow, the tubular transfer member provides fluid communication between the vial and a syringe, although the vial transferset of this invention may also be used to transfer fluid or liquid from a vial to another container, such as a second vial or an intravenous set. In the most preferred embodiment of the transferset of this invention, the piercing member includes at least one external generally longitudinal channel or groove rather than an internal lumen, thereby eliminating the problems associated with a conventional needle. Although the channel may take various forms and may include an internal channel, in the most preferred embodiment the channel is an external channel which extends generally longitudinally along at least a portion of the piercing member. As will be understood, the external channel in the piercing member extends generally longitudinally along the piercing member, but may extend spirally around the piercing member or include external and internal channels or multiple channels. Thus, when the piercing member is driven through the rim portion of the stopper, the external channel in the piercing member provides full fluid or liquid communication between the vial and the tubular transfer member. Of course, when the tubular transfer member is sealingly connected to a syringe, IV or the like, the tubular transfer member then provides fluid communication between the vial and the syringe. The preferred embodiment of the tubular transfer member then includes an annular or circular projecting sealing lip which is biased against the planar rim portion of the stopper assuring sealed communication between the vial and the tubular transfer member. In the most preferred embodiment, the sealing lip includes a relatively sharp edge which bites into the resilient stopper. As discussed more fully hereinbelow, the sealing lip of the tubular transfer member is preferably biased against the rim portion of the stopper sufficiently to stretch or prestress the rim portion of the stopper which overlies the vial opening.[0009]
• The preferred embodiment of the transferset of this invention further includes a cup-shaped cap which encloses the assembly and maintains the sterility of the transferset assembly. The cup-shaped cap preferably includes a radial rim portion adjacent an open end of the cup-shaped cap which preferably sealingly engages the stopper rim portion, a tubular portion surrounding the tubular transfer member and a closed distal end enclosing the distal ends of the tubular transfer member and the piercing member. Although the cap may include a separate cover portion which is integral or separate from the remainder of the cap, in the most preferred embodiment, the cap is integrally formed, such that the distal end portion may be removed prior to use. In the disclosed embodiment, the tubular portion of the cap spaced from the rim portion includes a radial groove or grooves which weaken the tubular wall forming a frangible connection. The distal end of the cap portion may then be removed simply by twisting the distal end of the cap, thereby breaking the frangible connection.[0010]
• The transfer assembly is secured to the vial by a generally tubular collar having a radially inwardly projecting portion or annular portion which is received over the cap radial rim portion, a tubular portion surrounding the cap radial rim portion and the vial rim and a distal radial rim portion which is received in the vial neck beneath the rim portion of the vial permanently securing the transfer assembly to the vial. In the most preferred embodiment of the transferset of this invention, the collar is formed of a malleable material such aluminum and the radial distal portion of the collar is then crimped into the neck portion of the vial beneath the vial rim portion. The collar of the transferset of this invention thus replaces the aluminum collar of a conventional vial and stopper assembly and easily accommodates the dimensional tolerances of the vial and stopper assembly. The vial is conventionally formed of glass or plastic.[0011]
• As described above, the planar radial rim portion of the vial stopper is preferably stretched and prestressed over the open end of the vial during assembly of the transferset on the vial. The proximate end of the tubular transfer member includes a projecting sealing lip having a diameter less than the internal diameter of the vial open end. In one preferred embodiment, the sealing lip has a relatively sharp edge which may also bite into the resilient stopper. In the most preferred embodiment, the piercing member is reciprocally supported by an internal surface of the tubular transfer member, such that the piercing member can move toward the stopper to pierce the stopper, but the piercing member is prevented from moving away from the stopper and the relatively sharp piercing proximate end of the piercing member extends beyond the proximate end of the tubular transfer member. Upon assembly of the transferset on the vial, the piercing end of the piercing member then deforms and, in one disclosed embodiment, partially penetrates the planar rim portion of the stopper which is preferably stretched and prestressed over the vial opening by the sealing lip of the tubular transfer member, as described above. This combination may reduce the force required for the piercing member to fully pierce the planar rim portion of the stopper upon activation which is another advantage of the present invention. In another disclosed embodiment, the piercing end of the piercing member is slightly rounded and the external channel does not extend through the proximate end, such that the relatively sharp piercing end does not initially penetrate the rim portion of the stopper, but stretches the stopper as described. This embodiment strengthens the piercing end. Further, deforming the stopper planar rim portion and stretching the planar portion over the open end of the vial, reduces the volume of elastomeric material deformed into the V-shaped groove or external channel in the piercing member following piercing of the stopper, thereby improving fluid flow through the channel. In the disclosed embodiment, the tubular transfer member includes an internal diameter adjacent its distal end which is smaller than the internal diameter adjacent its proximate end and the piercing member includes a radial lip having a diameter greater than the smaller internal diameter of the tubular transfer member adjacent its distal end. Stated another way, the tubular transfer member has a larger counter bore adjacent its proximate end. The piercing member is thus free to move telescopically in the tubular transfer member toward the stopper, but prevented from moving away from the stopper. In the most preferred embodiment, the piercing member has a reduced diameter portion adjacent its proximate end and a pointed piercing end further reducing the force required to drive the piercing member through the planar rim portion of the stopper.[0012]
• The most preferred embodiment of the transferset of this invention further includes a second seal surrounding the seal provided by the sealing lip of the tubular transfer member. In this preferred embodiment, the second seal is provided by an annular or circular lip which projects from the radial rim portion of the cap. In the most preferred embodiment, the radial rim portion of the cap includes at least one relatively sharp sealing lip which bites into the planar rim portion of the stopper providing an improved seal which maintains the sterile condition of the content of the transferset and prevents contamination.[0013]
• As described above, the transferset of this invention may be affixed on a conventional vial and stopper assembly by the pharmaceutical companies under sterile conditions when the vial is filled and the transferset of this invention prevents contamination of the contents of the vial. The cap of the transferset seals the transfer assembly and the collar permanently secures the assembly on the vial, particularly where a malleable collar is utilized. The radially inwardly projecting or annular lip portion of the collar is preferably compressed against the radial rim portion of the cap as the distal end of the collar is crimped into the reduced diameter neck portion of the vial beneath the vial rim during assembly. This compression against the resilient planar rim portion of the stopper compresses the sealing lips of the cap and the tubular transfer member against the rim portion of the stopper, such that the sealing lips bite into the rim portion of the stopper assuring sealed communication between the stopper and the tubular transfer member. In the most preferred embodiment, the piercing end of the piercing member is also partially driven into the prestressed rim portion of the stopper overlying the open end of the vial, reducing the stroke required to drive the piercing member through the rim portion of the stopper as described above.[0014]
• The method of assembling the improved transferset of this invention on a vial then includes inserting the elongated piercing member into the tubular transfer member, wherein the internal surface of the tubular transfer member telescopically supports the piercing member. Where the tubular transfer member includes an enlarged counterbore adjacent its proximate end and the piercing member includes a radial lip as described, the distal end of the piercing member is inserted through the proximate end of the tubular transfer member and the relatively sharp piercing end of the piercing member extends beyond the proximate end of the tubular transfer member. The method then includes inserting the distal end of the tubular transfer member into the open proximate end of the cup-shaped cap. In the most preferred embodiment of the transferset, the proximate end of the tubular transfer member includes a radial lip portion which is received within a counterbore of the radial rim portion of the cap, fixing the tubular transfer member in the cap, such that the projecting sealing lip of the tubular transfer member engages the planar rim of the stopper as described. Further, the piercing member is preferably releasably retained in the tubular transfer member, such that the components of the transferset and the collar may be preassembled and delivered in bulk to a pharmaceutical company, for example, for sterile assembly on vials. Finally, the assembled piercing member, tubular transfer member and cap are assembled on the vial and affixed by the collar. As described, the collar is most preferably formed of a malleable material such as aluminum and the radial rim portion of the collar is compressed against the rim portion of the cap as the distal end of the generally tubular cap is crimped into the reduced diameter neck portion of the vial beneath the vial rim. The compression of the radial rim portion of the collar against the rim portion of the cap compresses the resilient planar rim portion of the stopper, compressing the sealing lips into the rim portion of the stopper, stretching and prestressing the central portion of the planar rim portion of the stopper, assuring sealed communication between the vial and the tubular transfer member. In the most preferred embodiment, the method of this invention further includes driving the piercing end of the piercing member simultaneously into the planar radial rim of the stopper, deforming and may partially penetrate the stopper radial rim to reduce the stroke required to drive the piercing member through the stopper.[0015]
• The method of transferring fluid or liquid medicament from the vial to a syringe or other container then includes first removing the cover portion of the cap to provide access to the tubular transfer member and the piercing member. In the most preferred embodiment, a radial groove is provided in the tubular portion of the cap spaced from the radial portion of the cap providing a frangible connection, such that the cover portion can be removed from the rim portion of the cap simply by twisting the distal end of the cap, breaking the frangible connection and permitting removal of the cover portion which includes the distal end of the tubular portion of the cap the closed end.[0016]
• The transferset and vial assembly is now ready for use. As set forth above, the transferset of this invention may be utilized to transfer fluid from a vial to a syringe or IV set or any container; however, the disclosed embodiment of the transferset is specifically adapted to transfer liquid from a vial to a syringe or IV set or from a syringe or IV set to a vial. The distal end of the tubular transfer member includes a connector adapted to connect the tubular transfer member to a syringe to establish fluid communication between the tubular transfer member and the interior of a syringe, such as a Luer lock or Luer connector. A conventional syringe includes a tubular portion, a plunger having a head or fluid piston reciprocally mounted in sealed relation within the tubular portion and a reduced diameter tubular nozzle portion opposite the plunger head. The inside diameter of the tubular transfer member of the transferset is preferably greater than the outside diameter of the tubular nozzle portion of the syringe and the outside diameter of the syringe nozzle portion is generally approximately equal to the diameter of the distal end of the piercing member. Thus, the syringe nozzle portion may be telescopically received within the distal end of the tubular transfer member, wherein it is driven against the distal end of the piercing member. The reduced diameter nozzle portion is generally recessed within the tubular portion of the syringe, such that the proximate end of the syringe tubular portion surrounds the nozzle portion forming a tubular collar. The proximate end of the tubular collar includes a connector, such as a female Luer lock. In the disclosed embodiment, the distal end of the tubular transfer member includes a male Luer lock connector adapted to mate with the female Luer lock of the syringe.[0017]
• Following removal of the cover portion of the cap as described above, the connector on the syringe is connected to the connector on the distal end of the tubular transfer member which drives the reduced diameter nozzle portion of the syringe into the distal open end of the tubular transfer member and the free end of the syringe nozzle portion is then driven against the distal end of the piercing member, driving the piercing end of the piercing member through the planar rim portion of the stopper. In summary, the method includes connecting the syringe to the distal end of the tubular transfer member, establishing fluid communication between the syringe through the nozzle portion and driving the piercing end of the piercing member through the rim portion of the stopper. Fluid communication is thus established between the inside of the vial and the syringe through the tubular transfer member.[0018]
• In the most preferred embodiment of the transferset of this invention, wherein the piercing member includes an external generally longitudinal channel, this communication is established through the external generally longitudinal channel in the piercing member. In the most preferred embodiment, the channel in the piercing member extends from adjacent the piercing end to at least the enlarged portion of the piercing member and most preferably through at least an extended portion of the length of the piercing member. The connector on the syringe is most preferably a threaded connection, such as a Luer lock. In one embodiment, this threaded connection has several turns whereby the proximate end of the piercing member is driven completely through the planar rim portion of the stopper by threading the threaded connection of the syringe on the distal end of the tubular transfer member. In another embodiment, the proximate end of the piercing member is driven through the stopper by fluid pressure from the syringe.[0019]
• As will now be understood, the piercing member in the transferset of this invention has several important advantages over the prior art. First, the piercing member is easy to manufacture. The longitudinal channel may be a V-shaped channel for example which extends the entire length of the piercing member. Such a channel is easier to manufacture than a needle having very small lumen as presently used. More importantly, in the transferset of this invention, a piercing member having an external channel assures complete aspiration or reaspiration of the vial without requiring partial withdrawal of the needle which exposes the healthcare worker to being pricked by the needle (if inadvertently fully withdrawn) and contamination of the liquid medicament. The external channel provides full communication of the liquid content of the vial, whereas a needle with a lumen requires substantial withdrawal of the needle from the vial to provide full communication through the stopper as described above. Fluid communication between the syringe and the vial is then provided by the tubular transfer member rather than the needle in the transferset of this invention. Thus, the described piercing member provides several important advantages in the transferset of this invention over the prior art.[0020]
• As described, the transferset of this invention may be utilized to reconstitute dry or powdered drugs into liquid form with an appropriate diluent or solvent solution prior to administration to a patient. For example, the syringe may contain a solvent solution or diluent which is injected into the vial through the tubular transfer member and the external channel of the piercing member by depressing the plunger head of the syringe. The reconstituted drug or medicament may then be reaspirated from the vial to the same syringe by withdrawing the plunger head for administration to a patient. The healthcare worker is never exposed to a needle during this operation and the piercing member remains with the transferset and vial assembly because it is never connected to the syringe. The tubular transfer member is then removed from the syringe and replaced with a needle for application of the liquid medicament to a patient or connected directly to an IV line.[0021]
• As will be understood, the terms tubular and tubular portion are used herein to connote a generally tubular shape. Although the disclosed embodiments are generally cylindrical tubes which are more convenient to manufacture, the tubular portions may be of any convenient shape, including polygonal. Other advantages and meritorious features of the present invention will be more fully understood from the following description of the preferred embodiments, the claims and the appended drawings, a brief description of which follows.[0022]
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a side cross-sectional view of an assembled vial and fluid transfer assembly or transferset;[0023]
• FIG. 2 is an enlarged view of the encircled[0024]portion2 shown in FIG. 1;
• FIG. 3 is a partial side cross-sectional view of the vial and transferset assembly shown in FIG. 1 with the cover portion of the transferset removed;[0025]
• FIG. 4 is a partial cross-sectional view of the vial and transferset assembly as shown in FIG. 3 with a syringe oriented for connection to the transferset;[0026]
• FIG. 5 is a partial side cross-sectional view of the vial and transferset assembly with the syringe ready for connection to the transferset;[0027]
• FIG. 6 is a partial side cross-sectional view of the vial, transferset and syringe with the syringe connected to the transferset and the plunger of the syringe moved to transmit liquid from the syringe to the vial;[0028]
• FIG. 7 is an enlarged side-cross sectional view of FIG. 6 illustrating the fluid communication between the vial and the transferset;[0029]
• FIG. 8 is a top cross-sectional view of FIG. 6 in the direction of view arrows[0030]8-8;
• FIG. 9 is an exploded side elevation of the vial, transferset and syringe;[0031]
• FIG. 10 is an exploded side view of the transferset, vial and stopper prior to assembly;[0032]
• FIG. 11 is an enlarged side-cross sectional view of a second embodiment of a transferset and vial assembly;[0033]
• FIG. 12 is a side cross-sectional view of the vial and transferset of FIG. 11 illustrating piercing of the vial stopper;[0034]
• FIG. 13 is a partial side cross-sectional view of the vial and transfer set of FIGS. 11 and 12 illustrating the flow of fluid from the syringe to the vial;[0035]
• FIG. 14 is a perspective view of the piercing member utilized in the transferset shown in FIGS.[0036]11 to13;
• FIG. 15 is an enlarged view of the encircled[0037]portion15 of FIG. 13;
• FIG. 16 is a side partially cross-sectioned view of an alternative preferred embodiment of the transferset of this invention;[0038]
• FIG. 17 is a side elevation of the piercing member shown in FIG. 16; and[0039]
• FIG. 18 is an enlarged fragmentary side cross-sectional view of FIG. 16 illustrating the interconnection between the tubular transfer member and the cap of this embodiment.[0040]
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
• As described above, the fluid transfer assembly or[0041]transferset20 of this invention is adapted for establishing fluid communication with a conventional sealedvial22 as shown in FIG. 1. The vial includes aside wall portion24, abottom wall portion26, a reduceddiameter neck portion28 and arim portion30. The vial is conventionally formed of glass or plastic and includes an interior32 for receipt for example of a dry or liquid medicament, such as adry vaccine33. The vial is sealed with anelastomeric stopper34 which includes atubular portion36 and aplanar rim portion38. Thetubular portion36 of the stopper preferably has an external diameter slightly greater than theinternal diameter44 of the open end of the vial and, as will be understood by those skilled in the art, the end of the tubular portion may includeaxial slots40 in order to perform freeze drying of liquid in the vial. As will be understood, the vial may also include a gas, for example, to protect the liquid content of the vial, and thus the transferset of this invention is referred to as a fluid, rather than liquid transferset. Thecentral portion42 of theplanar rim portion38 is flexible and thus may be resiliently biased into thetubular portion36, prestressing thecentral portion42 as described below.
• The[0042]transferset20 of this invention preferably includes four components, including atubular transfer member46, a central piercingmember48 which is reciprocally supported in the tubular transfer member, a cup-shapedcap50 which encloses and seals the assembly and acollar member52 which secures the transferset to the vial as shown in FIG. 1. The proximate end of thetubular transfer member46 includes a circular orannular sealing lip54 as shown in FIGS. 1 and 2, which preferably includes a sharpdistal edge56 as shown in FIG. 2. As will be understood, the proximate end of thetubular transfer member46 may include a plurality of sealing lips, such as theconcentric sealing lips86 of thecap50 described below. In the disclosed embodiment, the proximate end of thetubular transfer member46 further includes aradial connector portion58 as shown in FIG. 2 which is described more fully hereinbelow. A connector, such as aLuer lock60, is provided adjacent the opendistal end62 of the tubular transfer member. The internal surface of thetubular transfer member46 includes a first smaller preferablyconical diameter64 adjacent thedistal end62 and a second larger generallycylindrical diameter66 or counterbore adjacent the proximate end.
• The[0043]distal end67 of the piercingmember48 includes a generallycylindrical barrel portion68 having an external diameter generally equal to or slightly less than theinternal diameter64 of thetubular transfer member46, such that the piercing member is telescopically supported in thetubular transfer member46 for movement toward thestopper34 as described below. The piercingportion70 adjacent the proximate end of the piercingmember48 may also be generally cylindrical and preferably has a diameter substantially less than the diameter of thebarrel portion68. In the disclosed embodiment, theportion73 of the piercing member between theradial rib75 and thebarrel portion68 is conical. The proximate end of the piercingmember48 includes a relatively sharp, preferably pointed piercingend72 and the piercingmember48 includes an external generallylongitudinal channel74 which provides communication between the interior32 of the vial and the interior of thetubular transfer member46 as described below.
• The piercing[0044]member48 further includes aradial rib75 which has a diameter greater than theinside diameter64 of thetubular transfer member46 adjacent its distal end and slightly smaller than theinside diameter66 of the counter-bore, such that the piercingmember48 can move toward the planarradial rim portion38 of the stopper for piercing of the stopper, but cannot move away from the stopper as shown in FIG. 1. In the preferred embodiment of the transferset of this invention, the sharp piercingend72 of the piercingmember48 is thus retained in thetubular transfer member46, such that the relatively sharp piercingend portion72 of the piercing member deforms thecentral portion42 of the stopper and may partially penetrate the stopper as shown, thereby reducing the stroke required to drive the piercing member through the stopper as described below.
• The[0045]cap50 includes atubular portion76 which surrounds thetubular transfer member46 preferably is spaced relation, aradial rim portion78 at its proximate end and a closeddistal end portion80 which encloses the distal ends of thetubular transfer member62 and the piercingmember67. Thecap50 is thus generally described as “cup-shaped”; however, the cap may have an open distal end which is closed by a separate removable closure, for example, such that the combination is cup-shaped. Thetubular portion76 of the cap includes a radial v-shapedexternal groove82, such that the proximate end of thetubular portion76 is retained to the distal portion by a relatively thinfrangible connection84 as shown in FIG. 2. Thegroove82 in the disclosed embodiment of thetubular portion76 of thecap50 is in the external surface as shown; however the groove may also be formed in the internal surface forming a frangible connection adjacent the external surface. Thegroove82, whether internal or external, may also be continuous as shown or interrupted. Alternatively, the cover portion may be connected to the remainder of the cap by spaced frangible connector portions. As described below, the distal portion of the cap or cover portion may then be removed by twisting the distal end of the cap for connection of the transferset to a syringe or the like. In the preferred embodiment of the transferset, theradial rim portion78 includes annular or preferably circularconcentric sealing lips86 which surround the sealinglip54 of the tubular transfer member. As shown in FIG. 2, thecircular lips86 on theradial portion78 of the cap surround the sealinglip54 on the tubular transfer member, providing a safety seal primarily to maintain sterility inside thecap50 prior to use, thereby extending the shelf life of the product. Although the disclosed embodiment includes twoconcentric sealing lips86 on the cap, it will be understood that one sealing lip may be utilized or a plurality of nonconcentric lips. The sealinglips86 preferably have a relatively sharp edge and are V-shaped, such that thelips86 bite into the resilientplanar rim portion38 of the stopper.
• The disclosed embodiment of the[0046]cap50 further includes an outerlongitudinal rim portion88 having an inside diameter generally equal to or slightly smaller than the outside diameter of theplanar rim portion38 of the stopper as shown in FIG. 1, such that thetransferset20 is accurately located on thestopper34 and therim portion30 of thevial22 with thetubular transfer member46 generally coaxially aligned with theopening44 through theneck portion28 of the vial. In the disclosed embodiment, the piercingmember48 is supported in thetubular transfer member46 with its longitudinal axis X coincident with the longitudinal axis of the vial and stopper. It may be desirable, however, in certain applications to provide a nonconcentric arrangement and thus the present invention is not limited to the concentric arrangement shown. Thetubular transfer member46 is accurately located and supported within thecap50 by a radial rim90 on theradial connector portion58 as shown in FIG. 2, which is received in arecess92 in the cap. The cap further includes a V-shaped radially inwardly projecting rib93, which is received in or snapped into a V-shapedgroove94 in the tubular transfer member as shown in FIG. 2, providing accurate secure location of thetubular transfer member46 in thecap50.
• The V-shaped interlock further permits preassembly of the[0047]tubular transfer member46 and piercingmember48 in thecap50 for bulk supply of the transferset andcollar52 to pharmaceutical companies, for example, for attachment to a vial, following filling of the vial with medicament, using thecollar52. In an alternative embodiment (shown in FIGS.16 to18 described below), the tubular transfer member is retained in thecap350 for bulk supply by an interlocking rib and depression on opposed surfaces of the tubular transfer member and the cap, preferably spaced inwardly or proximately from the frangible connection. Further, in the embodiment described below, the piercing member is releasably retained in the tubular transfer member for bulk assembly and supply to the applicator responsible for filling the container orvial22. Thus, as will be understood, various embodiments or means may be provided to retain thetubular transfer member46 in the cap for bulk supply to pharmaceutical companies for later assembly on a vial within the purview of this invention. In the disclosed embodiment, the piercingmember48 includes a small rampedradial rib73, spaced distally from theradial rib75, which provides an interference fit with theinternal surface64 of thetubular transfer member46 as best shown in FIGS. 5, 6,9 and10. This interference fit releasably retains the piercingmember48 in thetubular transfer member46 upon assembly of the piercing member in the tubular transfer member. Thus, the components of thetransferset20 are retained as an assembly for bulk sale and use as described.
• As set forth above, the[0048]collar52 is most preferably formed of a malleable material such as aluminum to accommodate the thickness tolerances of thestopper34 and therim portion30 of the vial. Thecollar52 includes atubular portion96 which surrounds the radial andlongitudinal rim portions78 and88 of thecap50, the planarradial rim portion38 of the stopper and therim portion30 of the vial, a radially inwardly projectingportion98 which overlies theradial rim portion78 of the cap and a distalradial portion100 which in the preferred embodiment is crimped into the reduceddiameter neck28 of the vial beneath thevial rim30. In the disclosed embodiment, thecollar52 further includes a distaltubular portion102 which surrounds the proximate end of thetubular portion76 of the cap and the radial V-shapedexternal groove82 as shown in FIG. 2. Thistubular portion102 reduces the likelihood of accidental removal of the distal portion of thecap50 and the distal end of thetubular portion102 includes arounded bead104 which prevents the healthcare worker from engaging a sharp metal edge when removing the distal end of the cap during use. The distal removable portion of the cap is referred to hereinafter as the cover portion. Alternatively, the cover portion may be threaded onto the proximate end of thetubular portion76 of the cap or connected by a “living hinge.” However, the preferred embodiment of thecap50 having afrangible connection84 as shown in FIGS. 1 and 2 reduces the cost of the cap of the transferset and assures maintenance of the sterile conditions prior to use.
• The method of assembling the transferset on a vial is best shown in FIGS. 9 and 10. The[0049]distal end67 of the piercingmember48 is inserted into the proximate end of thetubular transfer member46. As shown in FIG. 10, thebarrel portion68 of the piercing member is first received in the largerinternal diameter66, wherein theradial rib75 is generally equal to the diameter of theinternal surface66. Thebarrel portion68 of the piercing member is then received in thesmaller diameter surface64 until theradial rib75 engages theradial surface65 between theinternal surfaces66 and64 (FIG. 10) as shown in FIG. 1. The distal ends62 of the tubular transfer member and67 of the piercing member are then received in the open proximate end of thecap50 and thetubular portion76 of thecap50 is then received over thetubular portion102 of the collar and the assembly is received over the radialplanar rim portion38 of thestopper34 and the rim portion of thevial22.
• As noted above, the[0050]tubular transfer member46 is accurately aligned within and supported by thecap50. As shown in FIG. 2, the radial rib90 of the tubular transfer member is received within theradial groove92 of thecap50 and the V-shaped rib93 on the cap snaps into the mating V-shapedgroove94 in the tubular transfer member. Further, the outerlongitudinal rim88 on the cap is received over the radialplanar portion38 of the stopper, such that the entire transferset assembly is accurately aligned on thestopper34. Further, the piercingmember48 is accurately aligned and supported within thetubular transfer member46, such that the relatively sharp piercingend72 extends beyond the proximate end of thetubular transfer member46 and the piercingmember48 is able to move toward the stopper, but is restrained from withdrawing from the stopper by theradial rib75. As shown in FIGS. 9 and 10, the distalopen end100 of thetubular portion96 is initially coincident with thetubular portion76 as shown in phantom in FIG. 1. Upon assembly, however, theend100 is deformed or crimped into theneck portion28 of the vial beneath therim portion30, permanently securing thetransferset20 on thevial22. Theradial rim portion78 of thecap50 is simultaneously compressed against theplanar rim portion38 of the resilient stopper as thedistal end100 of thecollar52 is crimped, such that the piercingend72 of the piercingmember48 is pressed into thecentral portion42 of the stopper, which causes the piercingend72 to resiliently deform the unsupportedcentral portion42 of the stopper and, in the embodiment disclosed in FIGS.1 to4, the piercingend72 may partially penetrate thecentral portion42 of the stopper as shown in FIG. 2. As will be understood, it may not be desirable in some applications for the piercingend72 of the piercing member to partially penetrate thecentral portion42 of the stopper when the transferset is assembled on the vial, particularly where the vial and transferset assembly of this invention is to be stored for an extended period of time. In the alternative preferred embodiment of thetransferset320 shown in FIGS.16 to18, the piercingend372 of the piercingmember348 is slightly rounded to avoid prepenetration of the stopper. Thus, the relative sharpness of the piercingend72 and372 of the piercingmember48 and348 may be selected to either stretch or deform and prestress thecentral portion42 of theplanar rim portion38 of thestopper34 or deform and partially penetrate thecentral portion42 of the stopper, as shown in FIGS.1 to4. Further, the sharpness of thepointed end72 and372 of the piercing member will depend upon the material used to form the piercingmember48 and the material may be selected to either partially pierce the stopper or simply deform and stretch thecentral portion42 of the stopper.
• The[0051]annular sealing lip54 of thetubular transfer member46 is also simultaneously driven into thecentral portion42 of the stopper, stretching and prestressing thecentral portion42 of the stopper as shown in FIG. 2, and the sealinglips86 of thecap50 are driven into the resilient stopper providing an additional seal encircling the sealinglip54. In the most preferred embodiment, the sharp piercingedge56 of the sealinglip54 of thetubular transfer member46 slightly penetrates thecentral portion42 of the stopper, providing an improved seal surrounding the communication between the interior32 of thevial24 and thetubular transfer member46 when the piercingmember48 fully penetrates thestopper34 as now described.
• The transferset and vial assembly shown in FIG. 1 is now ready for use. As set forth above, the[0052]transferset20 may be assembled on thevial22 andstopper34 by the pharmaceutical company when thevial22 is filled under sterile conditions. In a typical application, the vial is filled with a dry or powdered medicament which may be reconstituted into liquid form with an appropriate diluent or solvent solution prior to administration to a patient. In such applications, the diluent or solvent solution is first injected into the vial by a syringe, such as theconventional syringe110 shown in FIGS.4 to6 and9. A conventional syringe includes atubular body portion112, atubular nozzle portion114 which extends beyond thetubular body portion112, aplunger116 having ahead portion118 havingexternal seals120, such as the0-ring seals shown in FIGS.4 to6. Theplunger shaft122 is generally cruciform in shape and may be integral with thehead118. Theplunger116 may be driven through or reciprocate through theinterior128 of thetubular body portion112 to eject or withdraw liquid through thenozzle portion114. A collar portion ortubular extension129 of thetubular body portion112 extends beyond the distal portion of thenozzle114, the interior surface of which includes a female Luer lock or female threads which are normally used to connect a needle to the syringe. As shown in FIG. 9, theshaft122 of theplunger116 generally includes a thumb orpush button132 and the body portion includes a radial, outwardly extendingfinger grip134, such that the plunger head may be reciprocated through thetubular body portion112 by gripping theradial finger grip134 and theplunger head118 is driven through the interior of the tubular body portion by engaging thepush button132 with the thumb. However, details of the design of various syringes are well known in the art and the transferset of this invention is not limited for use with any particular syringe design.
• Prior to use of the vial and transferset of this invention by a healthcare worker, for example, the cover portion of the[0053]cap50 must first be removed as shown in FIG. 3. This is accomplished with the disclosed embodiment of thetransferset20 simply by twisting the distal end portion of thecap50 as shown by arrow A in FIG. 3. This twisting motion breaks thefrangible connection84 formed by theradial groove82. The cover portion then comprises the distal portion of thetubular portion76 and the closeddistal end portion80 as shown in FIG. 3. The cover portion of thecap50 is thus removed from thetransferset20 exposing thedistal end67 of the piercingmember48 and thetubular transfer member46 as shown in FIG. 3. As described above, the distaltubular portion102 of the collar includes arounded bead104 which protects the fingers of the healthcare worker during removal of the cover portion of thecap50 which will now be more fully understood from FIG. 3.
• The[0054]transferset20 with the cover portion of thecap50 removed is now ready for receipt of an IV set or aconventional syringe110 as shown in FIG. 4. First, thesyringe110 is coaxially aligned with the axis of thetubular transfer member46. As shown, the diameter of thebarrel portion68 of the piercingmember48 is equal to or greater than the diameter of thenozzle portion114 of the syringe, such that thenozzle portion114 of the syringe will engage thedistal end67 of the piercingmember48.
• The[0055]syringe110 is then secured to thetubular transfer member46 and the piercingportion70 of the piercingmember48 is driven through thecentral portion42 of theresilient stopper34 as shown in FIGS. 5 and 6. As thetubular nozzle portion114 of thesyringe110 is driven into the opendistal end64 of thetubular transfer member46, the free end of thenozzle portion114 is driven against the distal67 of the piercingmember48, which drives the piercingend72 through thecentral portion42 of thestopper34 as shown in FIG. 5. The reduceddiameter piercing portion70 of the piercingmember48 is then driven through thecentral portion42 of the stopper by threading the male thread of theLuer lock60 at the distal end of thetubular transfer member46 into thefemale thread130 of the Luer lock on the extension orcollar129 of the syringe as shown in FIG. 6. The threading of the syringe on the distal end of thetubular transfer member46 drives thetubular nozzle portion114 of thesyringe110 into theinternal surface64 of thetubular transfer member46 and the free end of the tubular nozzle portion against thedistal end67 of thebarrel portion68 of the piercingmember48, which drives the piercingportion70 of the piercing member through thecentral portion42 of thestopper34, establishing fluid communication through theexternal channel74 and the interior32 of thevial22 as discussed more fully hereinbelow. As set forth above, the piercing of thecenter portion42 of thestopper34 by the piercingmember48 is facilitated by thecircular sealing lip54 on the proximate end of thetubular transfer member46, which stretches and prestresses the unsupportedcentral portion42 of the stopper which overlies thetubular portion36.
• In a typical application of the[0056]transferset20 of this invention, wherein thevial22 contains a drug or medicament in dry or powdered form which is reconstituted by a diluent or solvent solution in theinterior128 of the syringe, the liquid diluent or solvent may now be transferred to the interior of thevial22 simply by depressing theplunger116 of thevial110 as shown by arrow B in FIG. 6. The liquid in theinterior128 of the syringe is thus ejected through thetubular nozzle portion114 into theexternal channel74 of the piercingmember48 into thetubular portion34 of the stopper and thus into the interior32 of thevial22. As shown in FIG. 8, which is a cross-section through the rim of the vial as shown in FIG. 6, one configuration of the generallylongitudinal channel74 in the piercingmember48 is a V-shapedchannel74 which is relatively simple to manufacture. Further, the use of a V-shaped channel having an angle of about 15° to 60° does not materially weaken the piercing member and provides adequate communication between the interior32 of the vial and thetubular transfer member46 through thechannel74. A larger angle of about 45° to 60° may be preferred to limit manufacturing problems and avoid potential blockage of the groove. Further, thechannel74 may be of any convenient shape, including rectangular. As shown in FIG. 8, the resilient elastomericcentral rim portion42 of the stopper will be deformed into and partially fill thechannel74 in the piercing member when the piercingportion70 penetrates the stopper. The deformation and stretching of thecentral portion42 of the stopper over the opening of the vial by the sealinglip54 of the tubular transfer member however reduces the volume of elastomeric material which is deformed into thechannel74, thereby improving fluid communication through theexternal channel74.
• Generally, the liquid medicament is fully reconstituted by shaking the assembly as shown in FIG. 7. The[0057]liquid medicament136 may then be reaspirated into the same or a different syringe simply by withdrawing theplunger116 into thetubular body portion112 in the opposite direction from arrow B in FIG. 6. It is important to note from FIG. 7 that theliquid medicament136 is transferred from thevial122 through theexternal channel74, then from the external channel into thetubular transfer member46 to the syringe (not shown). This should be contrasted with a needle having a small internal lumen or bore, wherein the liquid medicament below the piercing end (72 of the piercing member48) cannot be reaspirated because the liquid must be transferred through the lumen of the needle. It should also be noted that thesharp end56 of the annular orcircular sealing lip54 seals the communication between the tubular transfer member and theexternal channel74 of the piercingmember48. This embodiment of thetubular transferset20 of this invention and method of assembly thus provides several important advantages over the prior art as described above.
• FIGS.[0058]11 to15 illustrate an alternative embodiment of the vial transferset and method of this invention, wherein the fluid pressure in the syringe is utilized to drive the piercing member through the central portion of the stopper rather than mechanical force as described above in regard to FIGS.1 to10. The components of thetransferset220 have been numbered in the same sequence as thetransferset20 shown in FIGS.1 to10, except that the components of thetransferset220 are numbered in the200 series for ease of description and reference to FIGS.1 to10 described above. Thevial22,stopper34 andsyringe110 may, however, be identical to the same components described above and are therefore numbered the same.
• In the[0059]transferset220 shown in FIGS.11 to15, thetubular transfer member246 has an axial length which is greater than the axial length of the piercingmember248, such that thedistal end267 of the piercing member is recessed in the smaller diameter opening264 of the tubular transfer member a distance equal to or greater than the length of thetubular nozzle114 of thesyringe110. This can be accomplished either by reducing the axial length of the piercingmember248 or increasing the length of thetubular transfer member246 as shown in FIGS.11 to15. Thus, in this embodiment, when the maleLuer lock connection260 on thetubular transfer member246 is threaded into the female threads of the Luer lock of thetubular extension129, the tubular extension is received within theinternal surface264 of thetubular transfer member246 without engaging thedistal end267 of the piercingmember248 as shown in FIG. 11. This somewhat simplifies the connection of thesyringe110 to thetubular transfer member246 compared to the embodiment of thetransferset20 shown in FIGS.1 to10 because the healthcare worker is not required to pierce the vial by urging thetubular nozzle portion114 of the syringe against thedistal end267 of the piercing member although the embodiment of thetransferset20 is relatively easy to assemble.
• The piercing[0060]end272 of the piercingmember248 is then driven through thecenter portion42 of thestopper34 by moving thehead118 of theplunger116 ofsyringe110 toward thenozzle114 of the syringe, which drives the liquid140 in thetubular body portion112 of the syringe against theradial rib275 of the piercingmember248. As best shown in FIG. 14, theradial rib275 on the piercingmember248 of thetransferset220 shown in FIGS.11 to15 provides a fluid seal. That is, theradial sealing rim275 extends into the external generallylongitudinal channel274 and theradial sealing rib275 has an external diameter generally equal to or slightly greater than the internal diameter of the internalcylindrical surface266 of thetubular transfer member46. In this embodiment, the tubular transfer member includes a secondenlarged bore280 adjacent the proximate end having an internal diameter greater than the external diameter of theradial sealing rib275. Thus, when the fluid pressure created by theplunger118 of thesyringe110 drives theradial sealing rib275 into theenlarged diameter portion280, fluid is permitted to flow around theradial sealing rib275 into the proximal portion of thechannel274 in the piercing member which has penetrated thecentral portion42 of the stopper as shown in FIG. 15.
• The preferred alternative embodiment of the[0061]transferset320 shown in FIGS.16 to18 operates and is assembled in the same manner as the embodiment of thetransferset20 shown in FIGS.1 to10. Further, the components of thetransferset320 are generally the same, including atubular transfer member346, a piercingmember348, a generally cup-shapedcap350 and acollar member352. Thus, the components of thetransferset320 are numbered in the same sequence as the components of thetransferset20 shown in FIGS.1 to10 except that the components of the embodiment of thetransferset320 shown in FIGS.16 to18 are numbered in the300 series. Where appropriate, the features of the components are also numbered in the same sequence for ease of reference to the above description and to avoid duplication of the description of this embodiment. Thus, for example, thetubular transfer member346 includes an annular orcircular sealing lip354, aLuer lock connector360 at its distal end, a first smallerinternal diameter364 and a larger proximateinternal diameter366 as described above. The following description of the components of thetransferset320 shown in FIGS.16 to18 will therefore be limited to the features which differ from the features of thetransferset20 shown in FIGS.1 to10.
• First, as best shown in FIG. 18, the[0062]tubular transfer member346 includes an integral generallytubular connector portion402, which in this embodiment, surrounds the proximate end of the tubular transfer member and is integrally joined to the remainder of the tubular transfer member at404. The external surface of theconnector portion402 includes a radially projectingrounded rib358 which is received in agroove392 formed in the inner wall of the cap, providing a simplified snap-in interlock between thetubular transfer member346 and thecap350. The threadedLuer connector360 on the tubular transfer member is also slightly modified; however, theLuer connector360 is also conventional. The inner wall of thetubular portion376 of thecap350 also includes a plurality of sealingribs406 in this embodiment which engage the outer wall of theconnector portion402 of thetubular transfer member346 which seal the connection between the cap and the tubular transfer member and prevent contamination of the transferset.
• The piercing[0063]member348 has also been modified in this embodiment. First, as best shown in FIG. 17, the piercingend372 of the piercingmember348 is slightly rounded to prevent premature penetration of theplanar rim portion38 of thestopper34 shown, for example, in FIG. 1. That is, the slightly rounded piercingend372 will deform and stretch theplanar rim portion38 of the stopper, but will not partially penetrate the rim portion as shown in FIG. 1. The piercingend372, however, is “relatively sharp” and will pierce the planar rim portion of theelastomeric stopper34 when the piercingmember348 is driven into the stopper as described above. Further, theexternal channel374 in the piercingmember348 terminates short of the piercing end as shown in FIG. 17, such that thechannel374 includes arounded end wall408 spaced slightly from the proximate end of the relatively sharp piercingend372. Terminating the external channel374 a few millimeters (e.g. 7 mm) short of the piercingend372 strengthens the piercingend372 for penetration of theplanar rim portion38 of the stopper. In this embodiment, the piercingmember348 is releasably retained in the tubular transfer member by an interlocking rib and groove as best shown in FIGS. 16 and 17. In the disclosed embodiment, the piercing member includes anarcuate groove410 adjacent theradial rib375 and theinternal surface364 of thetubular transfer member346 includes an interlockingarcuate rib412 as shown in FIG. 16 which releasably retains the piercingmember348 in thetubular transfer member346. In the disclosed embodiment of the piercingmember348, the barrel portion includes two spacedflats414 which receive the mold ejector pins (not shown) which make it easier to remove the piercing member from the mold, but the flats do not form a functional part of the invention.
• Thus, as described above, the[0064]transferset320 shown in FIGS.16 may be preassembled in bulk with the collar for distribution to pharmaceutical companies, for example, for attachment to a vial under sterile conditions. The barrel portion368 of the tubular transfer member further includes spaced flats which receive ejector pins in a mold to simplify release of the piercingmember348 from the mold, but are not functional in thetransferset assembly320. Finally, in this embodiment, thedistal end367 of the piercingmember348 is rounded which also simplifies molding of the piercingmember348.
• The components of the transferset[0065]328 are assembled and secured to avial22 as described above. Upon assembly of thetransferset320 as shown in FIG. 16, theend300 of thetubular portion396 is crimped into the reduceddiameter neck portion28 of the vial as described above. The assembly of thetransferset320 on the vial drive the sealinglips354 and386 of the tubular transfer member into the planarradial rim portion38 of the stopper, sealing the assembly. The cover portion of thecap350 is then removed by twisting the distal end, breaking thefrangible connection384 as described. The transferset may then be utilized to transfer fluid to or from the vial by connecting asyringe110 or IV set (not shown) to theLuer lock connector360 as described above. As set forth above, the operation of thetransferset320 in transferring fluid to or from a vial is the same as described above in regard to FIGS.1 to10.
• As will be understood by those skilled in the art, various modifications may be made to the vial transferset and method of this invention within the purview of the appended claims. For example, the[0066]tubular transfer member46,246 and346 may be polygonal, in which case, thebarrel portion68,268 and368 of the piercingmember48,248 and348 may be similarly polygonal and thetubular portion76,276 and376 of the cap may either by cylindrical or polygonal. Further, thecollar52,252 and352 may be formed of any suitable malleable material or may also be formed of a suitable plastic although in the disclosed embodiment the collar may be formed of aluminum. The piercing member and tubular transfer member may be formed of various materials including, for example, a medical grade polycarbonate having the appropriate strength and suitable for sterilization. Thecap50,250 and350 may also be formed of a medical grade polycarbonate. Further, as set forth above, the external generallylongitudinal channel74,274 and374 in the piercingmember48,248 and348 respectively, may be of various configuration including, for example, a spiral or a discontinuous longitudinal groove. Having described the vial transferset and method of this invention, it is now claimed as set forth below.

Claims (41)

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. The fluid transfer assembly defined in

claim 1

, wherein said piercing member includes an external generally longitudinal channel providing communication between said vial open end and said tubular transfer member when said piercing member pierces said stopper.

3. The fluid transfer assembly defined in

claim 1

, wherein said piercing member piercing end extends beyond said tubular transfer member and said piercing member is releasably restrained in said tubular transfer member with said sharp piercing end partially penetrating said stopper.

4. The fluid transfer assembly defined in

claim 1

, wherein said tubular portion of said cap includes a radial groove weakening the wall of said tubular portion for removal of said closed distal end from said fluid transfer assembly prior to use.

5. The fluid transfer assembly defined in

claim 1

, wherein said open distal end of said transfer member includes an external Luer connector for receiving an Luer connector of said syringe.

6. The fluid transfer assembly defined in

claim 1

, wherein said radial rim portion of said tubular transfer member includes a projecting circular sealing lip surrounding said tubular portion of said transfer member which engages said stopper rim portion, deforming and stretching said stopper rim portion over said vial open end, sealing the communication between said vial open end and said tubular transfer member when said piercing member pierces said stopper.

7. The fluid transfer assembly defined in

claim 6

, wherein said circular lip of said transfer member extends generally perpendicular to said radial rim portion of said transfer member and includes a pointed edge which bites into said rim portion of said stopper.

8. The fluid transfer assembly defined in

claim 6

, wherein said radial rim portion of said cap includes a circular sealing lip surrounding said tubular portion of said cap which engages said stopper rim portion in sealed relation providing a seal to maintain the sterility of said fluid transfer assembly when assembled on said vial.

9. The fluid transfer assembly defined in

claim 1

, wherein said tubular portion of said cap includes a radial groove weakening the wall of said tubular portion for removal of said closed distal end of said cap and said collar radial portion includes a tubular portion overlying said groove in said cap.

10. The fluid transfer assembly defined in

claim 1

, wherein said piercing member distal end is cylindrical having an external diameter generally equal to an internal surface of said tubular transfer member adjacent said distal end of said transfer member supporting said piercing member generally perpendicular to said rim portion of said stopper.

11. The fluid transfer assembly defined in

claim 10

, wherein said piercing member includes a radial lip received in an enlarged counter bore in said tubular transfer member which releasably retains said piercing member in said tubular transfer member with said sharp piercing end partially penetrating said stopper prior to use.

12. The fluid transfer assembly defined in

claim 1

, wherein said tubular transfer member proximate end includes a radial flange which interlocks with said cap.

13. The fluid transfer assembly defined in

claim 1

, wherein said collar is formed of a relatively thin malleable metal and said tubular portion is crimped into said vial neck beneath said vial rim permanently securing said transfer assembly to said vial.

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:

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.

15. The fluid transfer assembly defined in

claim 14

, wherein said collar is formed of a relatively thin malleable material and said distal radial portion of said collar is crimped in said vial neck of said vial beneath said vial rim permanently securing said transfer assembly to said vial.

16. The fluid transfer assembly defined in

claim 14

, wherein said tubular portion of said cap includes a radial groove weakening the wall of said tubular portion for removal of said cover portion prior to use.

17. The fluid transfer assembly defined in

claim 14

, wherein said open distal end of said tubular transfer member includes an external Luer connector for receipt of a Luer connector of said syringe.

18. The fluid transfer assembly defined in

claim 14

, wherein said radial rim portion of said tubular transfer member includes a projecting circular sealing lip surrounding said tubular portion of said transfer member which engages said stopper rim portion, said projecting lip portion stretching said rim portion of said stopper over said vial open end sealing the communication between said vial open end and said tubular transfer member when said piercing member pierces said stopper and reducing deformation of stopper material into said piercing member external channel, thereby improving fluid communication through said channel.

19. The fluid transfer assembly defined in

claim 18

, wherein said circular sealing lip of said transfer member includes a pointed edge which bites into said rim portion of said stopper, whereby said tubular fluid transfer member is sealingly supported on said stopper rim portion.

20. The fluid transfer assembly defined in

claim 18

, wherein said radial rim portion of said cap includes a circular sealing lip which surrounds said tubular portion of said cap, said sealing lip of said cap engaging said stopper rim portion in sealed retention providing a seal for maintaining sterility of the interior of said fluid transfer assembly.

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:

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.

22. The method of transferring fluid medicament between a conventional sealed vial and a second container as defined in

claim 21

, wherein said fluid transfer assembly includes a cup-shaped cap having a radial rim portion adjacent an open end, said method including mounting said cap with said rim portion opposite said stopper radial rim portion, a tubular portion surrounding said transfer member and a cover portion enclosing said open distal end of said transfer member and said distal end of said piercing member, said cover portion attached to said tubular portion by a frangible connector, said method including mounting said fluid transfer assembly on said vial under sterile conditions with said cup-shaped cap enclosing said transfer assembly maintaining said tubular transfer member and said piercing member under sterile conditions until use, then removing said cover portion by breaking said frangible connector, then attaching said syringe to said tubular transfer member.

23. The method of transferring fluid medicament between a conventional sealed vial and a second container as defined in

claim 21

, wherein said collar is formed of a relatively thin malleable metal having a tubular portion and a radial portion, said method including telescopically receiving said collar over the components of said fluid transfer assembly and said vial rim with said radial portion overlying said components of said transfer assembly and said tubular portion receiving said vial rim, then crimping a free end of said tubular portion beneath said vial rim extending into said vial neck permanently securing said transfer assembly on said vial.

24. The method of transferring fluid medicament between a conventional sealed vial and a second member as defined in

claim 23

, wherein said tubular transfer member includes a generally circular sealing lip surrounding said tubular portion of said transfer member which is generally aligned with said tubular portion, said method including compressing said sealing lip against said rim portion of said stopper as said collar is crimped on said vial, stretching said rim portion of said stopper before piercing of said stopper by said piercing member.

25. The method of transferring fluid medicament between a conventional sealed vial and a second member as defined in

claim 24

, wherein said circular sealing lip of said tubular transfer member has a pointed edge, wherein said method includes pressing said sealing lip against said rim portion of said stopper, such that said sealing lip pointed edge bites into said stopper rim portion providing an improved seal of the communication between said vial open end and said tubular transfer member when said piercing member pierces said stopper.

26. The method of transferring fluid medicament between a conventional sealed vial and a second container as defined in

claim 24

, wherein said piercing member is releasably retained in said tubular transfer member with said piercing end extending beyond said tubular transfer member, said method including compressing said sealing lip of said tubular transfer member and said piercing end of said piercing member against said rim portion of said stopper as said collar is crimped on said vial, said piercing end of said piercing member resiliently deforming said rim portion of said stopper.

27. The method of transferring fluid medicament between a conventional sealed vial and a second container as defined in

claim 21

, wherein said connector on said tubular transfer member and said connector portion of said second container are mating threaded connectors and said connector portion of said second container extends beyond a body portion of said second container, said method including threading said threaded connector portion of said second container on said threaded connector of said tubular transfer member thereby driving said nozzle portion of said syringe against said distal end of said piercing member and said sharp end of said piercing member through said stopper rim portion, thereby establishing said fluid communication between said second container and said vial.

28. The method of transferring fluid medicament between a conventional sealed vial and a second container as defined in

claim 21

, wherein said second container is a syringe having a tubular body portion initially filled with fluid, a plunger retracted within said syringe tubular body portion, and a reduced diameter tubular nozzle portion extending beyond said tubular body portion, said piercing member including a radial sealing portion engaging an interior surface of said tubular transfer member, said method including attaching said syringe on said connector on said tubular transfer member thereby establishing fluid communication between said nozzle portion of said syringe and said distal end of said tubular transfer member, then driving said plunger of said syringe toward said nozzle portion, driving fluid against said radial sealing portion of said piercing member and driving said piercing end of said piercing member through said stopper, thereby establishing said communication between said syringe and said vial.

29. The method of transferring fluid medicament between a conventional sealed vial and a second container as defined in

claim 21

, wherein said fluid transfer assembly includes a cup-shaped cap, said cap including a tubular portion having an internal diameter greater than said tubular transfer member, and an open proximate end, a radial rim portion adjacent said open end and a closed distal end, said tubular transfer member including a circular sealing lip surrounding said tubular portion of said tubular transfer member, said method including assembling said fluid transfer assembly by inserting said piercing member in said tubular transfer member with said piercing end adjacent said proximate end of said tubular transfer member, receiving said cap over said tubular transfer member with said closed distal end enclosing said distal ends of said tubular transfer member and said piercing member, then assembling said tubular transfer member, piercing member and cap on said rim portion of said stopper with said tubular transfer member and said piercing member in generally coaxial alignment with said open end of said vial, generally perpendicular to said stopper rim portion, then securing said assembly on said vial with said collar and simultaneously compressing said proximate end of said tubular transfer member against said stopper, compressing said circular sealing lip against said stopper rim portion, stretching said lip portion over said vial open end and sealing communication between said piercing member external channel and said tubular transfer member when said piercing member pierces said stopper.

30. The method of transferring fluid medicament between a conventional sealed vial and a second container as defined in

claim 29

, wherein said piercing member is assembled in said tubular transfer member with said piercing end extending beyond said tubular transfer member proximate end, said method then including compressing said tubular transfer member on said stopper rim portion with said piercing end of said piercing member deforming said stopper.

31. The method of transferring fluid medicament between a conventional sealed vial and a second container said radial rim portion of said cap includes a circular sealing lip surrounding said tubular portion of said cap adjacent to said tubular portion, said method including pressing said circular sealing lip of said cap against said rim portion of said stopper, providing a seal surrounding said piercing member.

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:

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.

33. The method of assembling a fluid transfer assembly on a conventional vial as defined in

claim 32

, wherein said method includes assembling said piercing member in said tubular fluid transfer member such that said piercing end extends beyond said proximate end of said tubular fluid transfer member and said piercing member restrained from moving further into said tubular fluid transfer member, said method further including compressing said piercing end of said piercing member into said rim portion of said stopper, deforming said stopper as said sealing lip of said tubular fluid transfer member is compressed into said stopper rim portion.

34. The method of assembling a fluid transfer assembly on a conventional vial as defined in

claim 32

, wherein said radial rim portion of said cap includes a projecting sealing lip surrounding said tubular portion of said cap and said method including compressing said sealing lip of said cap against said rim portion of said stopper as said sealing lip of said tubular fluid transfer member is compressed into said rim portion of said stopper, providing a seal maintaining the sterility of said fluid transfer assembly.

35. The method of assembling a fluid transfer assembly on a conventional vial as defined in

claim 32

, wherein said method further includes transferring fluid from said vial to a conventional syringe or vice versa, wherein said distal end of said tubular fluid transfer member includes a threaded connector, said method including removing said closed distal end of said cap, threading the threaded connector of a conventional syringe to said threaded connector of said tubular fluid transfer member and transferring fluid by moving the plunger of the syringe.

36. The method of assembling a fluid transfer assembly on a conventional vial as defined in

claim 35

, wherein said syringe includes a tubular portion, a plunger having a head reciprocally mounted in sealed relation within said tubular portion and a reduced diameter nozzle portion extending beyond said tubular portion in fluid communication with said tubular portion, said distal end of said tubular fluid transfer member having a threaded connection and said syringe having a mating threaded connection, said method including threading said syringe threaded connector on said threaded connector of said tubular fluid transfer member, thereby driving said nozzle portion of said syringe against said distal end of said piercing member and said piercing end of said piercing member through said stopper rim portion, thereby establishing fluid communication between said vial and said syringe through said tubular transfer member and permitting transfer of fluid from said syringe to said vial or from said vial to said syringe by movement of said plunger in said tubular portion of said syringe.

37. The method of assembling a fluid transfer assembly on a conventional vial as defined in

claim 32

, wherein said second container is a syringe which includes a tubular portion, a plunger having a head reciprocally mounted in sealed relation within said tubular portion and a reduced diameter nozzle portion opposite said plunger head in communication with said tubular portion, wherein said syringe is initially filled with fluid and said plunger is retracted within said syringe tubular portion and said piercing member distal end is generally closed, said method including attaching said syringe connector to said connector on said tubular fluid transfer member, establishing communication between said nozzle portion of said syringe and said distal end of said tubular fluid transfer member, then driving said plunger of said syringe toward said nozzle portion, driving fluid against a radial sealing portion of said piercing member and driving said piercing end of said piercing member through said stopper and thereby establishing fluid communication between said syringe and said vial.

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:

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.

39. The method of securing a fluid transfer assembly on a conventional vial and stopper assembly as defined in

claim 38

, wherein said circular sealing lip includes a sharp edge having a diameter greater than an inside diameter of said vial open end, such that said circular sealing lip overlies a portion of said stopper generally planar rim portion which overlies said vial radial rim portion, said method including compressing said sharp edge of said circular sealing lip into said stopper generally planar rim portion while said distal end of said collar is crimped into said vial neck portion, causing said sharp edge of said sealing lip to penetrate said stopper generally planar rim portion sealing the communication between said vial open end and said fluid transfer assembly.

40. The method of securing a fluid transfer assembly on a conventional vial and stopper assembly as defined in

claim 38

, wherein said circular sealing lip has a diameter less than an inside diameter of said vial open end and said stopper tubular portion, such that said circular sealing lip overlies an unsupported central portion of said stopper generally planar rim portion, said method including compressing said circular sealing lip into said stopper generally planar rim portion as said distal end of said collar tubular portion is crimped into said vial neck portion, said circular sealing lip stretching and prestressing said central portion of said stopper planar rim portion.

41. The method of securing a fluid transfer assembly on a conventional vial and stopper assembly as defined in

claim 40

, wherein said fluid transfer assembly includes a piercing member having a piercing end supported in said fluid transfer assembly generally perpendicular to said stopper planar rim portion and said piercing end of said piercing member extending beyond said generally flat annular surface, said method including compressing said piercing end of said piercing member into said stopper generally planar rim portion to partially, but not totally penetrate said generally planar rim portion of said stopper as said collar tubular portion is crimped into said vial neck portion.

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