WO2001028489A1

WO2001028489A1 - Transfer set for vials and other medical containers

Info

Publication number: WO2001028489A1
Application number: PCT/US2000/027708
Authority: WO
Inventors: Hubert Jansen; Jean-Claude Thibault
Original assignee: Becton Dickinson And Company
Priority date: 1999-10-20
Filing date: 2000-10-06
Publication date: 2001-04-26
Also published as: DE60019446T2; WO2001028490A1; DE60019446D1; ATE292948T1; JP2012152592A; JP2003511212A; US6626309B1; ATE262883T1; AU782098B2; AU781905B2; EP1221924A1; AU7869900A; AU7869800A; EP1221923B1; ES2218231T3; JP2014237014A; DE60009532T2; US6378714B1; EP1221924B1; EP1221923A1

Abstract

An improved transfer set assembly for transferring fluids between a first container, such as a medicament vial and a second container, such as a syringe, which includes an integral polymeric transfer assembly having a tubular collar portion, a radial portion overlying the rim of the first container, an outer tubular portion and an inner tubular portion which is integrally joined to the outer tubular portion by a radial intermediate web portion, a piercing member telescopically received in the inner tubular portion having a piercing end to pierce the closure sealing the open end of the first container and a removable closure which seals the open ends of the outer and inner tubular portions of the transfer assembly. The tubular collar portion, which may be separate from the inner and outer tubular portions, is formed of composite polymer including a relatively soft polymer and a relatively rigid polymer, such that the free end of the collar portion may be deformed radially inwardly or crimped into the neck of the first container, yet sufficiently rigid to retain its shape following deformation and resistant to creep to maintain a seal between the transfer assembly and the first container. The proximate end of the inner tubular portion includes a sharp edge which seals against the closure of the first container. The preferred embodiment of the closure is frangibly connected to the free end of the outer tubular portion of the transfer assembly and provides a biological seal.

Description

TRANSFER SET FOR VIALS AND OTHER MEDICAL CONTAINERS

FIELD OF THE INVENTION

This invention relates to an improved transfer set for vials and other medical containers which may be attached to a conventional vial having an elastomeπc stopper or other closure for transferring fluid under steπle conditions between a vial or other container and a second container such as a syπnge. The collar portion of the transfer set is preferably formed of a polymer which may be permanently deformed radially to secure the transfer set to the container, yet sufficiently πgid to retain its shape following deformation and resist creep.

BACKGROUND OF THE INVENTION It is conventional to store medicament such as drugs in a sealed vial or other container for later use. Such medicaments may be in a dry or powdered form to increase the shelf life of the drugs and reduce inventory space. Such dry or powdered drugs are generally stored in a sealed vial and reconstituted in liquid form for administration to a patient by adding a diluent or solvent. Alternatively, the drug may be in liquid or even gaseous form. A conventional vial for stoπng medicament generally includes an open end, a radial πm portion surrounding the open end and a reduced diameter neck portion adjacent the πm portion. The vial is conventionally sealed with an elastomeπc stopper or closure which generally includes a generally tubular portion or annular πb inserted mto the neck of the vial and a generally planar πm portion which overlies the vial πm. The stopper is normally secured to the vial with a thin malleable metal cap, such as aluminum. The aluminum cap includes a tubular portion which surrounds the πm portions of the stopper and vial, an inwardly pro_jecting annular πm portion which overlies the πm portion of the stopper and a distal end portion which is cπmped or deformed radially into the vial neck beneath the vial πm portion. Because aluminum is malleable, the collar accommodates the buildup of tolerances of the dimensions of the stopper and vial πm. The dimensions and tolerances of standard vials and stoppers are set by the International Standards Organization (ISO).

The radial portion of the aluminum cap which overlies the stopper πm portion may be closed, in which case the aluminum cap is removed by "peeling" the aluminum cap from the vial. A pre-s t tab located in the middle area is provided which overlies the vial πm, permitting the cap to be torn from the top and peeled from the vial pπor to use This embodiment of an aluminum cap has several disadvantages First, the teaπng of the metal cap creates sharp edges which may cut or damage sterile gloves and cut the person adrrunisteπng the drug, thereby exposing both the healthcare worker and the patient to disease and contamination of the drug. Second, the teaπng of the aluminum cap generates metal particles which may also contaminate the drug The dangers associated with the teaπng of an aluminum cap has been solved in part by adding a "flip-off plastic cap. In one such embodiment, the aluminum collar includes a central opening and a shallow plastic cup-shaped cap is received over the aluminum collar having a central projecting πvetmg portion which is received and secured in the central opening of the aluminum collar. The plastic cap is then removed by forcing the flip-off cap away from the aluminum collar, which tears an annular serrated portion surrounding the central opening and exposes an opening m the collar for receipt of a hypodermic needle or the like. This embodiment reduces but does not eliminate the possibility of teaπng the steπle gloves of the healthcare worker. More importantly, however, aluminum dust is still created which may contaminate the medicament. It is also important to note that metallic dust is also created simply by forming and affixing the aluminum collar to the vial because aluminum dust is created in forming the aluminum collar, cπmping of the collar and removal of the flip-off plastic cap.

Aluminum collars have also been used to secure fluid transfer sets on medicament vials. Transfer sets may be utilized, for example, to transfer fluid from a syπnge to a vial, such as to reconstitute a dry or powdered drug in a vial by adding a diluent or solvent. The reconstituted drug may then be withdrawn from the vial by the syπnge. The inner surface of the transfer set may be part of the drug fluid path and the aluminum collar or πng may bπng aluminum particles in the steπle room where the drug is added to the vial or into the drug fluid path contaminating the drug There have been attempts to reduce this problem by applying a coating to the aluminum cap or collar. Finally, the pπor art also includes snap-on cup-shaped plastic caps or collars having a radially inwardly projecting end portion which is snapped over the πm portion of the vial. Snap-on plastic collars, however, do not assure adequate sealing of the vial or fully accommodate the tolerances of standard vials and stoppers as required. The pπor art also discloses plastic medicament vial transfer sets However, such plastic transfer sets are relatively expensive having several lnterfitting parts and are difficult to use. The need therefore remains for a transfer set for vials and other medical containers which may be utilized with conventional containers, such as medicament vials or cartridges, which assures sealing of the container and which achieves a good level of cleanliness, without particles or dust which may contaminate the medicament, the transfer set or the clean room and which does not expose the healthcare worker to sharp metal edges. The need also remains for a transfer set which may be easily secured to a vial or other medical container and which is relatively inexpensive, simple in construction and easy to use.

SUMMARY OF THE INVENTION As set forth above, the improved transfer set assembly of this invention may be utilized with conventional medicament vials and other medical containers to transfer fluids between the medical container and a second container such as a syπnge. The transfer set assembly of this invention eliminates the problems associated with malleable metal or aluminum collars, but accommodates the buildup of tolerances of the πm portion of the container and the elastomeπc stopper. The transfer set assembly of this invention is relatively simple in construction and may be formed of a malleable polymer which has sufficient πgidity to retain its shape following deformation and which is resistant to creep.

The preferred embodiment of the transfer set assembly of this invention is adapted for attachment to a conventional medicament vial having an open end, a πm portion suπounding the open end and a reduced diameter neck portion adjacent the πm portion and wherein the open end of the vial is sealed with a conventional elastomeπc stopper. The disclosed embodiment of the transfer set assembly of this invention is also adapted for transferπng fluids between a conventional syπnge and a vial and may thus be utilized to reconstitute dry or powdered drugs stored in the vial by adding diluent or solvent to the vial with the syπnge. As will be understood, however, the improved fluid transfer set of this invention may also be used to transfer fluids between other types of containers, particularly medicament containers, and is therefore not limited in its use or application The transfer set assembly of this invention includes an integral preferably polymeπc transfer assembly including an outer tubular portion preferably having a radial end portion adapted to be connected to the vial or other container and an opposed free end, a cylindrical inner tubular portion spaced radially inwardly from, generally coaxially aligned with and preferably integrally joined to the outer tubular portion having a first end portion which is attached to the container in generally coaxial alignment with the open end of the container and adapted to sealmgly engage the container having a free end. The assembly further includes a piercing member which is telescopically received in the inner tubular portion having a piercing end adapted to pierce a closure sealing the open end of the container and an opposed free end. In the most preferred embodiment of the transfer set of this invention, the piercing member includes an axial passage including an enlarged intermediate chamber which receives a filter for filteπng fluid received therethrough. In another disclosed embodiment, the piercing member includes an external open generally longitudinal channel providing fluid communication through the stopper or closure. As used herein, generally longitudinal means that the passage or channel transmits the fluid longitudinally and thus may include, for example, spiral channels.

Finally, the improved transfer set assembly of this invention includes a removable closure sealing the opposed free ends of the inner and outer tubular portions of the transfer assembly sealing the container for later use. The most preferred embodiment of the closure is cup-shaped closure having frangible connectors in the πm portion providing a good seal and permitting easy removal of the closure. The πm of the cup-shaped closure includes an upper and lower portion with the upper and lower portions interconnected by frangible portions spaced circumferentially along the interface separating the two portions and the lower portion retaining the upper portion and the lid to the transfer set until severance of the frangible portions. The frangible portions are angularly situated about the axis of the lid so they have some angular and radial strength but are easily compressible. In the disclosed embodiment, the frangible portions are pyramidal shaped and frangible so that the upper portion can be fractured or broken by either tilting or twisting the lid to remove it from the transfer set. Further, severance of the frangible portions in response to initial separation of the upper and lower portions serves to provide integral and unmistakable evidence of tampenng with the medical container and the medication contained therein. Further, the upper and lower portions include a plurality of paired spacer blocks preferably alternating with frangible portions. These pairs of spacer blocks are of trapezoidal shape and taper axially toward each other. The blocks partially bπdge the gap formed between the spaced axial edges of the upper and lower portions and have outer ends that touch or are axially very closely juxtaposed with each other. The closure is fitted over the top of the transfer set by simply axially pushing it until the projections deflect slightly and snap onto the transfer set. Duπng such installation, the blocks bear axially so that no significant force is transmitted through the frangible portions and consequently prevent braking of the frangible portions duπng assembly.

In the preferred embodiment of the transfer set assembly which is adapted to transfer fluids between a conventional vial having an elastomeπc stopper and a second container, the free end of the internal tubular portion includes a sharp edge that deforms the elastomeπc stopper duπng assembly and provides a seal between the opening formed in the elastomenc stopper and the passage through the inner tubular portion. Further, the free end of the inner tubular portion includes an external Luer lock for threaded receipt of a syπnge. The piercing member is releasably retained within the passage through the inner tubular portion by interlocking πbs, such that the piercing portion is adjacent or partially penetrates the planar portion of the elastomeπc stopper The free end of the piercing member is preferably generally spheπcal, such that the syπnge engages the free end of the piercing member and dπves the piercing portion through the planar portion of the elastomeπc stopper As set forth above, the prefeπed embodiment of the piercing member includes an axial passage, preferably including a filter When the piercing end of the piercing member is dπven through the planar portion of the elastomeπc stopper, communication is provided through the piercing member and the inner tubular portion of the transfer assembly Alternatively, where the piercing member includes an external generally longitudinal passage, the internal tubular portion of the transfer assembly provides fluid communication for transfer of fluids

As descπbed above, the transfer assembly of the transfer set of this invention is preferably formed of polymer which is sufficiently malleable to permit radial deformation, yet sufficiently πgid to maintain its shape following deformation and resistant to creep In the preferred embodiment of the transfer set assembly of this invention, the integral polymeπc transfer assembly includes a tubular collar portion which suπounds the planar portion of the elastomeπc stopper and the πm of the vial or other medicament container having a free end which is deformed radially inwardly into the reduced diameter neck portion of the container to secure the transfer set to the container The free end may include an annular resilient πng retained to the internal surface adjacent the free end which prevents rotation of the tubular collar portion on the container

In the most preferred embodiment of the transfer set assembly of this invention, the integral transfer assembly is formed of a compost polymer including a polymer alloy or melt blend which includes a relatively tough soft malleable copolymer and a relatively πgid polymer The composite polymer is most preferably a polymer alloy of a relatively soft, malleable copolymer and a relatively πgid polymer The preferred relatively πgid polymer is a polyamide or polycarbonate and the preferred relatively soft copolymer may be selected from polyesters or polyolefins The resultant polymer alloy or composite preferably has an elongation at yield between 5% and 10% and elongation at brake greater than 100% with a flexural modules of greater than 1900 MPa

As set forth above, the transfer set assembly of this invention may be utilized with a conventional medical vial or other medical container having a conventional elastomeπc stopper In the prefeπed embodiment of the transfer set of this invention, the collar portion is integral with the coaxial tubular transfer assembly thus eliminating the requirement for malleable metal collars or caps, such as aluminum. The transfer set assembly of this invention is relatively inexpensive and simple to manufacture, particularly when compared with transfer sets having aluminum collars having protective metal coatings The transfer set assembly of this invention assures an excellent seal of the container and can be injection molded in a clean environment or washed, if necessary Finally, the transfer set assembly of this invention accommodates the tolerances of the vial and particularly the buildup of tolerance vaπations in the combination of a conventional vial and elastomeπc stopper. Other advantages and meπtoπous features of the present invention will be more fully understood from the following descπption of the preferred embodiments, the appended claims and the drawings, a bπef descπption of which follows.

BRIEF DESCRIP ION OF THE DRAWINGS Figure 1 is a side elevation of a preferred embodiment of the transfer set assembly of this invention assembled on a conventional medical vial;

Figure 2 is a partial side cross-sectional view of the transfer set assembly and vial shown in Figure 1 ready for use;

Figure 3 is a partial side cross-sectional view similar to Figure 2 following removal of the closure and dπving of the piercing member through the planar portion of the elastomeπc stopper;

Figure 4 is a partial side cross-sectioned view of an alternative embodiment of the transfer set assembly of this invention assembled on a conventional vial; and

Figure 5 is a partial top perspective view of the transfer set shown in Figure 4 illustrating an alternative embodiment of the closure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Figures 1 to 3 illustrate a preferred embodiment of the transfer set assembly 20 of this invention assembled on a conventional vial 22. As set forth above, the transfer set assembly of this invention may be utilized to transfer vaπous fluids under steπle conditions between vaπous types of containers However, the disclosed embodiment of the transfer set assembly 20 is particularly, but not exclusively adapted to transfer fluids between medical vials of the general type disclosed and a syπnge. The disclosed embodiment of the vial includes an inteπor 24 which may, for example, contain dry or powdered medicaments, a cy ndπcal opening 26 and a radial πm portion 28 which surrounds the opening 26 The disclosed embodiment of the vial further includes a reduced diameter neck portion 30 adjacent the πm. Medicament vials of this type are generally formed of glass or a steπhzable plastic. The opening 26 of the vial is typically closed with an elastomeπc stopper 32 having a generally tubular body portion 34 and a planar πm portion 36 which overlies the πm 28 of the vial. The stopper 32 is generally formed of a resilient elastomeπc mateπal such as synthetic or natural rubber. The central portion 38 of the planar πm portion 36 may be pierced with a hypodermic needle, for example, to either withdraw fluid from the vial or add a solvent or diluent to the vial where the medicament in the vial is a dry or powdered drug. The generally tubular portion 34 of the stopper has an external diameter slightly greater than the internal diameter of the cyhndπcal opening 26 of the vial to provide a tight or interference fit.

The transfer set assembly 20 of this invention includes an integral, preferably polymeπc transfer assembly 40, a piercing member 42 which is telescopically supported in the transfer assembly and a cap or closure 44. The integral transfer assembly 40 includes a tubular collar portion or first tubular portion 46, an integral radial portion 48, a second tubular portion or outer tubular portion 50 and a third tubular portion or inner tubular portion 52. In the disclosed embodiment, the outer tubular portion 50 is integrally connected to the inner tubular portion 52 by an intermediate radial web 54. As descπbed more fully herembelow, the integral transfer assembly 40, or the tubular collar portion 46 if made as a separate item, is preferably formed of a polymer which is sufficiently malleable to permit radial deformation or cπmpmg, yet sufficiently πgid to maintain its shape following deformation The collar portion 46 surrounds the planar πm portion 36 of the elastomeπc stopper 32 and closely surrounds the πm 28 of the vial and the collar portion includes a free end 56 which is radially deformed or cπmped around the πm 28 into the reduced diameter neck portion 30 of the vial to πgidly secure the transfer set assembly 20 to the vial. In the prefeπed embodiment, the radial portion 48 of the transfer assembly includes an annular barb 58 which is compressed into the planar πm portion 36 of the elastomeπc stopper duπng assembly of the transfer set assembly on the vial providing an additional seal and a steπhty barπer assuπng accurate tolerances The free end 57 of the inner tubular portion 52 preferably is relatively sharp and is dπven into the planar portion 36 of the elastomeπc stopper, providing the pπmary seal for the internal passage 60 through the inner tubular portion 52. The inner tubular portion 52 in the disclosed embodiment further includes an external Luer lock connector 61 preferably including threads 62 adjacent its free end 64 for receipt of the tubular portion of a conventional syπnge or other medicament delivery system The outer tubular portion 50 in the disclosed embodiment includes a reduced diameter portion 66 and the free end 68 has a larger diameter than the tubular portion adjacent the radial portion 48 as shown in Figures 2 and 3 The free end portion 68 also includes a plurality of spaced annular πbs 70, as shown and further discussed below

The piercing member 42 is telescopically received in the internal passage 60 of the inner tubular portion 52 of the transfer assembly The piercing member includes a body portion 72, a reduced diameter piercing portion 74 having a relatively sharp piercing edge 76 in this embodiment, which is adapted to pierce the central portion 38 of the elastomeπc stopper. The disclosed embodiment of the piercing member includes an axially longitudinal fluid passage or channel 78 and an intermediate chamber 80 including a filter 82 for filteπng fluid transferred through the passage 78 The filter 82 preferably is disc-shaped and may be any conventional filter including porous and semipermeable polymeπc filters The piercing member 42 is releasably retained in the internal passage 60 of the inner tubular member 52 by a πb 84 on the lnner tubular portion 52 and an annular concave fillet 86 on the piercing member (see Figure 3)

The preferred embodiment of the closure or cap 44 provides a stenle seal for the transfer set, is easily removed and provides clear evidence of tampeπng. The preferred embodiment of the cap or closure 44 is best shown in Figures 1 and 2. The closure includes an end or lid portion 88, an inner tubular portion 90 which closely receives the free end portion 68 of the outer tubular portion 50 as shown in Figure 2 and an outer frangible tubular portion 92 The inner tubular portion 90 provides a biological barπer as does the annular barb 58 of the collar portion 46 The outer tubular frangible portion 92 compπses an upper portion 94 and a lower portion 96 interconnected by integral frangible connector portions 98 which are angularly situated about the axis of the closure. The frangible portions 98 are of pyramidal shape and frangible so that the upper portion 94 can be fractured or broken by either tilting or twisting the upper portion 94 to remove the upper portion 94 with the lid portion 88 and the inner tubular portion 90 from the transfer set. In addition, severance of the frangible portions in response to initial separation of the upper and lower portions 94 and 96 serves to provide unmistakable evidence of tampeπng with the medical container and the medication therein.

The upper and lower portions 94 and 96 of the closure further include a plurality of circumferentially paired or opposed spacer blocks 100 and 102, respectively, which in the disclosed embodiment are of trapezoidal shape and tapper axially toward each. The spacer blocks 100 and 102 partially bπdge the gap formed between the axially spaced edges of the upper and lower portions and have ends that touch axially or are very closely juxtaposed with each other. The closure is fitted over the top of the free ends of the outer and inner tubular portions 50 and 52 by simply axially pushing the closure until the projections deflect slightly to receive the upper πbs 70 and snap m place. Duπng such installation, the spacer blocks 100 and 102 bear axially together so that no significant force is transmitted through the frangible connectors 98 and thus prevent braking of the frangible connectors 98 duπng assembly Following assembly of the closure 44 on the tubular free ends 68 of the outer tubular portion 50 and assembly of the transfer set on the vial, the transfer set is leady for use. Because the vial and transfer set are hermetically sealed, the assembly may be stored as permitted by the medicament contained within the vial.

Figure 3 illustrates the transfer set assembly following removal of the closure and movement of the piercing member 42 to pierce the central portion 38 of the stopper and to provide communication between the mteπor 24 of the vial and a second container, such as a syπnge (not shown) Following removal of the upper portion 94 of the closure by braking the integral frangible connector portions 98, the lower portion 96 remains entrapped between the πbs 70 as shown. In a typical application wherein diluent or solvent is added to dry or powdered medicament in the vial 22 and the reconstituted drug is removed, the tubular barrel portion of the syπnge is received over the free end 64 of the inner tubular portion 52 and threaded on the threads 62. Duπng the threading, the barrel portion of the syπnge is moved against the body portion 72 of the piercing member 42, dnvmg the sharp end 76 of the reduced diameter piercing portion 74 through the central portion 38 of the elastomeπc stopper 32 as shown in Figure 3. The plunger of the syπnge then dnves the solvent or diluent through the axial longitudinal passage 78 of the piercing member, through the filter 82 into the inteπor 24 of the vial. The reconstituted drug may then be withdrawn from the vial by withdrawing the syπnge plunger. As will be understood by those skilled m this art, conventional syπnges (not shown) include a tubular barrel portion and a plunger which reciprocates under pressure exerted by the healthcare worker and may be withdrawn by pulling on the plunger which withdraws the fluid from the vial

The preferred polymer selected for the integral transfer assembly 40 can best be descπbed by its physical properties The polymer must be sufficiently malleable to permit radial deformation or cπmpmg, yet sufficiently πgid to retain its shape following deformation. The polymer must also be sufficiently resistant to creep to maintain the seal between the integral transfer assembly and the container following radial deformation. It has been found that a polymer having an elongation at yield between 5% and 10% and an elongation at break greater than 100%, combined with a flexural modulus of greater than 1,900 MPa has supeπor performance. Where the mtegral transfer assembly 40 of this invention is utilized for sealing vials containing a medicament, the polymer should also be steπhzable and, in certain applications such as the vial transfer set assembly of this invention, the polymer is preferably relatively clear and maintains its claπty under the stress of deformation or cπmping. It has been found that certain polymer alloys or composite polymers including melt blends or alloys and co-polymers having polymers of different malleability and πgidity are preferred in such applications. That is. the plastic integral transfer assembly 40 of this invention is preferably formed of a polymer alloy, composite polymer or co-polymer including a relatively ngid polymer and a tough relatively soft malleable co-polymer. The most prefeπed polymer is a polymer alloy or melt blend including a polyamide or polycarbonate as the πgid polymer providing the strength and resistance to creep desired for this application. The relatively soft malleable co-polymer may be selected from vaπous polymers including polyesters and polyolefms; however, a polymer alloy including a polycarbonate or polyamide and a polyester has been found particularly suitable for this application.

As will be understood, vaπous polymeπc melt blends, alloys, composites and co-polymers are being developed on a rapidly increasing basis and therefore the plastic collar of this invention is not limited to a specific polymer, provided the polymer has the desired physical properties descπbed above. Suitable polymers for the plastic collar of this invention include EASTAR® MB polymers, which are melt blend and alloy polymers and EASTAR® thermoplastic polymers, which are neat polymers sold by Eastman Chemical Company of Kingsport, Tennessee and Eastman Chemical AG of Zug, Switzerland under the trade names "DA003, DN003" and "DN004". These mateπals are polymer melt blends, alloys and co-polymers of polycarbonate or polyamide and polyester. As used herein, the terms melt blends and alloys refer to polymeπc compositions having two or more polymers of different physical properties or characteπstics, such as the EASTAR® polymers of Eastman Chemical Company descπbed above which include a polycarbonate or polyamide and a polyester The polymer selected may also include fillers and other constituents which would be more accurately descπbed as a composite although the base polymers may still be a polymeπc melt blend or alloy As used herein, the term composite is used m its broadest sense to include alloys or melt blends, composites and co-polymers As will be understood, the manufacturer or supplier of the raw mateπal will normally blend the polymers based upon the specifications of the customer The polymers may be co- injected to form a polymeπc melt blend, alloy or composite or formed by any other suitable processes. It is anticipated, however, that other polymers having the descπbed physical characteπstics may also be utilized in the plastic collar or cap of this invention In certain applications, it may also be desirable to coat at least the mteπor surface of the collar portion 46 shown in Figures 2 and 3 with a thermoplastic elastomer, or the entire collar may have a thin layer of a thermoplastic elastomer The thermoplastic elastomer coating may be applied as a film or by co-injection with the polymer forming the integral transfer assembly 40. The transfer assembly 40 and the closure 44 may be formed by conventional injection molding processes.

Figures 4 and 5 illustrate an alternative embodiment of the transfer set assembly 120 of this invention. Because certain of the components are similar to the components of the transfer set assembly 20 shown in Figures 1 to 3, the components are numbered in the same sequence to limit duplication of descπption. The transfer set assembly 120 is assembled on a conventional vial 22 as descπbed above In this embodiment, the elastomeπc stopper 132, which is also conventional, includes a generally tubular portion 134, a generally planar πm portion 136 and a reduced diameter central portion 138 which is pierced by the piercing member 142, as descπbed below The disclosed integral polymeπc transfer assembly 140 is very similar to the transfer assembly 40 descπbed above, including the first tubular collar portion 146, the radial portion 148 and the inner and outer tubular portions 152 and 150, respectively The outer and inner tubular portions are integrally interconnected by a radial web 154. However, in this embodiment, the free end 156 of the outer tubular portion 150 includes a radial flange 170 to receive the closure descπbed below. As descπbed above, the free end 156 of the tubular collar portion 146 is deformed radially inwardly or cπmped into the reduced diameter neck portion 30 of the vial. However, in this embodiment, an elastomeπc O-πng 157 located in an annular concave groove on the inside surface of the free end 156 of the collar portion which prevents relative rotation of the transfer set on the vial. Additional anti-rotation means are provided by the radial barbs 158 which are pressed into the πm portion 136 of the elastomeπc stopper when the transfer set is assembled on the vial as descπbed above. The embodiment of the piercing member shown in Figure 4 includes a body portion 172, a reduced diameter piercing portion 174 and a piercing end 176 The piercing member is releasably retained in the internal passage 160 in the inner tubular portion 152 by an annular πb 184 on the inner surface of the inner tubular portion as descπbed above. In this embodiment of the piercing member, the piercing member includes a V-shaped external channel 178 which extends from adjacent the piercing end 176 through a portion of the body portion 172 rather than a longitudinal channel 78 as descπbed above When the piercing portion 174 of the piercing member is dπven through the center portion 138 of the elastomeπc stopper, the V-shaped 178 provides communication through the stopper into the internal passage 160 of the inner tubular portion 152. Thus, when a conventional syπnge (not shown) having a female Luer lock connector, for example, is threaded to the threads 162 and the piercing portion is dπven through the central portion 138 of the elastomeπc stopper, fluid communication is provided between the barrel portion of the syπnge and the inteπor 24 of the vial through the V-shaped channel 178. The external channel 178 provides some advantages over the axial longitudinal passage 78 descπbed above for fluid communication between the inteπor 24 of the vial and the inteπor passage 160 when the piercing portion 174 is dπven through the central portion 138 of the stopper. A significant advantage is the ability to fully reaspirate any medicament present in the vial. As will be understood, the external channel 178 may be continuous and extend longitudinally as shown or extend spirally or be discontinuous Otherwise, the piercing member 142 serves the same function as the piercing member 42 descπbed above.

The closure 144 shown in Figures 4 and 5 is a peel-off seal which seals the internal components of the transfer set, may be easily removed and provides an indication of tampeπng. The disclosed embodiment of the closure includes a sealing lid portion 186 which is circular to accommodate the shape of the annular flange portion 170 of the outer tubular portion and may be formed of paper, plastic, aluminum or foil which is adhesively bonded to the radial flange portion 170 This embodiment includes an integral tab 184 having a central portion 188 which is welded or adhesively bonded to the free end of the outer tubular portion by glue 180 Secuπng the central portion 188 to the transfer set prevents inadvertent removal of the seal and provides evidence of tampeπng The free end 192 of the tab may be easily gπpped for peeling off the seal 144 from the transfer set The peel-off seal 144 thus provides steπle sealing of the transfer set, can easily be removed and provides evidence of tampeπng

As descπbed above in regard to transfer set 20, the transfer set 120 shown in Figures 4 and 5 is assembled on the vial 22 and elastomeπc stopper 132 by compressing the radial portion 148 of the transfer assembly against the resilient stopper and then cπmping or radially deforming the free end 156 of the collar portion 146 toward the reduced diameter neck portion 30 of the vial. The piercing member 142 is preassembled into the passage 160 of the inner tubular portion from the end 156 to releasably retain the piercing member m the inner tubular portion. Compression of the radial portion 148 against the resilient elastomeπc stopper, deforms the stopper in a similar manner descπbed in connection with the example of Figures 1 through 3 This assembly can be done under steπle conditions, for example, at the pharmaceutical company where the medicament is added to the inteπor 24 of the vial, thus assuπng the integπty of the medicine The peel-off seal 144 in Figures 4 and 5 and the closure 44 in Figures 1 to 3 provides evidence of tampeπng and assures steπle condition of the transfer set pπor to use The peel-off seal 144 is then removed by the healthcare worker and the transfer set 120 is utilized to transfer fluid between the vial and a second container, such as a conventional syπnge as descπbed above.

As will be understood by those skilled in the art, vaπous modifications may be made to the embodiments of the transfer set assembly of this invention within the purview of the appended claims. For example, vaπous closures may be utilized m addition to the closures disclosed herein. Further, the inner and outer tubular portions of the transfer assembly may be separate from the collar portion 46 and 146 wherein, for example, the collar includes a radial portion which overlies the radial portion of the outer tubular portion 50, 150. Further, depending upon the ultimate use of the transfer set, the Luer lock 61, 161 may be replaced with a connector suitable for the second container.

Claims

WHAT IS CLAIMED IS:

1 A sealed container and transfer set assembly, compπsmg a first container having an open end, a πm portion suπoundmg said open end and a reduced diameter neck portion adjacent said πm portion, a stopper located within said first container open end, a fluid transfer set mounted on said first container open end for transferπng fluid between said first container and a second container, said transfer set including a first tubular collar portion having a free end permanently deformed radially into said first container reduced diameter neck portion retaining said transfer set on said first container, a radial portion integral with said first tubular collar portion overlying said first container πm portion, a second tubular portion integral with said radial portion generally coaxially aligned with said vial open end having a free end, a third tubular portion spaced radially inwardly from and generally coaxially aligned with said second tubular portion having a first end sealingly engaging said stopper and an opposed free end, a piercing member telescopically received within said third tubular portion having a piercing end adjacent said stopper, an opposed end and a channel for transmitting fluid between said vial and the container, and a removable closure closing said free end of said second tubular portion and said opposed free end of said third tubular portion; whereby fluid may be transfeπed between said first container and said second container upon removal of said closure and telescopic movement of said piercing member to pierce said stopper.

2. The sealed container and transfer set assembly defined in Claim 1, wherein said third tubular portion is integrally joined to said second tubular portion.

3. The sealed container and transfer set assembly defined in Claim 2, wherein said third tubular portion is integrally joined to said second tubular portion by an integral radial web.

4. The sealed container and transfer set assembly defined in Claim 2, wherein said first, second and third tubular portions are integrally formed from a polymer which is sufficiently malleable to permit radial deformation of said free end of said first tubular portion, yet sufficiently πgid to maintain its shape following deformation and sufficiently resistant to creep to maintain the seal between said transfer set and said first container.

5. The sealed container and transfer set assembly defined in Claim 1, wherein said polymer is relatively clear and maintains its claπty under the stress of deformation.

6. The sealed container and transfer set assembly defined in Claim 2, wherein said first, second and third tubular portions are integrally formed of a composite polymer including a relatively soft malleable polymer and a relatively πgid polymer.

7 The sealed container and transfer set assembly defined in Claim 1, wherein said closure is formed of plastic and compπses a portion overlying said free end of said second tubular portion and said opposed free end of said third tubular portion and an integral tubular closure portion suπoundmg said free end of said second tubular portion, said integral tubular closure portion compπsing first and second portions integrally connected by longitudinal integral frangible portions permitting removal of said closure by braking said longitudinally extending integral frangible portions.

8 The sealed container and transfer set assembly defined in Claim 7, wherein said closure includes a second integral tubular closure portion extending into said free end of said second tubular portion.

9 The sealed container and transfer set assembly defined in Claim 1, wherein said piercing member includes an axial passage extending through said piercing end.

10 The sealed container and tiansfer set assembly defined in Claim 9, wherein said piercing member axial passage includes an intermediate radial chamber having a filter wherein filteπng fluid transmitted through said axial passage between said first container and said second container.

11. A transfer set assembly for transferring fluids between an open end of a first container and an open end of a second container under steπle conditions, said transfer set assembly compπsing: an integral polymeπc transfer assembly including an outer tubular portion having a radial end portion adapted to be connected to said first container and an opposed free end, a cyhndπcal tubular inner portion spaced radially inwardly from, generally coaxially aligned with and integrally joined to said outer tubular portion, said inner tubular portion having a first end portion generally coaxially aligned with said open end of said first container and adapted to sealmgly engage said first container and an opposed free end; a piercing member telescopically received in said inner tubular portion of said transfer assembly having a piercing end adapted to pierce a closure sealing said open end of said first container and an opposed free end; and a removable closure overlying and sealing said opposed free ends of said inner and outer tubular portions of said transfer assembly.

12. The transfer set assembly defined in Claim 11, wherein said inner and outer tubular portions of said transfer assembly are integrally joined by an intermediate radial web portion.

13. The transfer set assembly defined in Claim 11, wherein said radial end portion of said transfer assembly outer tubular portion includes an integral tubular collar portion having a free end adapted to be deformed radially inwardly to secure said transfer assembly to said first container.

14. The transfer set assembly defined in Claim 13, wherein said integral polymeric transfer assembly is formed of a polymer which is sufficiently malleable to permit radial deformation of said free end of said integral tubular connector portion yet sufficiently rigid to retain its shape following deformation and sufficiently resistant to creep to maintain a seal between said integral polymeric transfer assembly and said first container.

15. The transfer set assembly defined in Claim 14, wherein said integral polymeric transfer assembly is formed of a composite polymer including a relatively soft malleable polymer and a relatively rigid polymer.

16. The transfer set assembly defined in Claim 11, wherein said piercing member includes an external open generally longitudinal channel providing fluid communication through said piercing member.

17. The transfer set assembly defined in Claim 11, wherein said piercing member includes a longitudinal axial channel therethrough providing fluid communication through said piercing member.

18. The transfer set assembly defined in Claim 17, wherein said longitudinal axial channel includes an intermediate radial chamber having a filter therein filteπng fluid transfeπed through said piercing member.

19. The transfer set assembly defined in Claim 11, wherein said closure is formed of plastic compπsing a portion overlying said free ends of said inner and outer tubular portions of said transfer assembly and an integral tubular closure portion surrounding said free end of said outer tubular portion, said tubular closure portion compπsing first and second portions integrally connected by longitudinally extending integral frangible portions permitting removal of said closure from said outer tubular portion by braking said integral frangible portions.

20. The transfer assembly defined m Claim 19, wherein said closure includes a second integral tubular closure portion extending into said free end of said outer tubular portion of said transfer assembly.

21. The transfer assembly defined in Claim 11, wherein said outer tubular portion of said transfer assembly includes external Luer lock connectors and said piercing member has a generally spheπcal end portion opposite said piercing end.