Abstract:
An apparatus for removal of premixed drugs or reconstitution of lyophilized drugs and for the injection of the reconstituted drug into the patient. The apparatus includes a syringe assembly and an adapter assembly that can be removably connected to a medicament container containing a premixed drug or lyophilized medicament. The syringe assembly of the apparatus includes a body portion to form a liquid chamber between the forward end of the body portion and the piston and a syringe cannula assembly. The syringe cannula assembly, which can be removably interconnected with the body portion, comprises a cannula support and a hypodermic needle sealably connected to the cannula support. The adapter assembly comprises an adapter preferably molded from a moldable plastic that includes a top wall, an adapter cannula connected to and extending from the top wall and a variety of connectors connected to the top wall for removably interconnecting the adapter with the medicament container. The adapter assembly further includes syringe connector member connected to the top wall for removably interconnecting the syringe with the adapter in a manner to uniquely position the syringe cannula within the lumen of the adapter cannula wherein it is completely shielded from external contamination and prevent print damage and injury to the user.

Description:
BACKGROUND OF THE INVENTION  
       [0001]     1. Field of the Invention  
         [0002]     The present invention relates generally to medicament administration. More particularly, the invention concerns a novel fluid medicament delivery apparatus that is specially designed to facilitate the aseptic administration of drugs to patients.  
         [0003]     2. Discussion of the Prior Art  
         [0004]     Medicaments intended for parenteral administration are typically stored in a medicament container in either in liquid, powdered or lyophilized form. Typically, lyophilized drugs are packaged in standard glass vials that are sealed with a pierceable rubber stopper and a crimped metal cap. A suitable liquid diluent must be added to the vial to reconstitute the powdered or lyophilized drug before use. In accordance with typical prior art methods, this reconstitution step was accomplished by drawing a measured amount of diluent, such as water, into a syringe from a diluent vial. The sealed vial containing the powdered or lyophilized drug was then accessed using a hypodermic needle and syringe to add the liquid diluent to the vial. The vial was then in inverted and shaken to intermix the drug with the liquid diluent. This done, the reconstituted drug was withdrawn into the syringe and was injected into the patient.  
         [0005]     It is apparent that when reconstitution of a drug is required, the prior art processes required at least two fluid transfers. The problem of ensuring proper fluid transfer under acceptable aseptic conditions during these two fluid transfers was formidable and was especially acute in the case of self-administration of drugs by patients in a homecare environment. For example, during the fluid transfers, the rubber stopper that is disposed within the top of the vial must be penetrated by the syringe needle. Typically, the rubber stopper is not sterile and, accordingly, the exposed needle is exposed to non-sterile conditions. Furthermore, as the needle penetrates the rubber stopper it will inevitably become contaminated with small particles of rubber that are dislodged from the rubber stopper during the needle penetration step. Additionally, this two-step process is quite cumbersome for physicians and particularly for homecare caregivers to accomplish, often under the stressful conditions that frequently exist at the bedside of a patient.  
         [0006]     One approach to overcoming the drawbacks of the prior art methods as described in the preceding paragraphs is disclosed in U.S. Pat. No. 6,238,372 to issued to Zinger et al. The Zinger et al. patent discloses a drug vial mixing and transfer device having one or more ports with interconnecting fluid passageways. The ends of the ports are attached either to a piercing connector or a syringe. The piercing connector is used to support and penetrate the rubber stoppers of the standard glass drug vials filled that are with powdered or lyophilized drugs or a liquid diluent, during the transfer of the liquid diluent and drug solutions between the vials and the syringe. In one form of the invention, the ports and connectors are mounted on a base and a stopcock type valve is used to coordinate communication between the fluid passageways of the different ports. Retainers mounted on the base hold the syringe and vials in place during the liquid transfer operations.  
       SUMMARY OF THE INVENTION  
       [0007]     By way of summary, the present invention concerns a disposable shrouded vial adapter with preconnected, integral “med push” hypodermic needle for low-cost, economical reconstitution of lyophilized drugs and for the direct injection of the reconstituted drug into the patient. In one form of the invention, the apparatus comprises a syringe assembly and a novel adapter assembly that can be removably connected to a medicament container or vial containing a liquid medicament, a powdered medicament or a lyophilized medicament. The syringe assembly of the apparatus includes an aspirator component that includes a body portion having a forward end and a piston slidably carried within the body portion to form a liquid chamber between the forward end of the body portion and the piston. The aspirator connector component of the syringe assembly, which comprises a syringe cannula assembly is adapted to be removably interconnected with the aspirator component. This novel aspirator connector component comprises a cannula support and a syringe cannula connected to the cannula support.  
         [0008]     In one form of the invention the adapter assembly comprises an adapter, preferably molded from a moldable plastic, that includes a body portion having a tapered bore, a top wall connected to the body portion, an adapter cannula connected to and extending from the body portion and a container connector means connected to the top wall for removably interconnecting the adapter with the medicament container. The container connector means can be of various configurations that telescopically receive and securely grip the upper portion of the medicament container. Uniquely, when the cannula support portion of the aspirator connector component is sealably received within the tapered bore of the body portion of the adapter assembly, the syringe cannula portion of the aspirator connector component is strategically positioned within the lumen of the adapter cannula where it is completely shielded from external contamination.  
         [0009]     It is an object of the present invention to provide a method and apparatus for reconstituting a lyophilized drug and for then delivering the reconstituted drug to a patient The method of the invention makes use of an apparatus of the character described in the preceding paragraph and is carried out in a manner such that the hypodermic syringe component of the apparatus is at all times protected from external contaminants and need not be used to penetrate the rubber stopper of the medicament container containing the drug that is to be reconstituted.  
         [0010]     Another object of the invention is to provide a method of the aforementioned character in which off-the-shelf syringe body components that have been pre-filled with a suitable diluent can be used to accomplish the reconstitution step of the method of the invention.  
         [0011]     Another object of the invention is to provide apparatus of the class described in which the adapter component includes filter means for filtering the fluid that is aspirated from the medicament container.  
         [0012]     Another object of the invention is to provide apparatus of the class described in which the adapter component includes vent means for venting to atmosphere any gases that may be contained within the medicament container.  
         [0013]     Another object of the invention is to provide apparatus of the class described herein that is of a simple design and is easy use in both hospital and homecare environments.  
         [0014]     Another object of the invention is to provide an apparatus as described in the preceding paragraph which can be inexpensively manufactured so that the apparatus can be economically disposed of after use.  
         [0015]     Another object of the invention is to provide apparatus of the class described herein that can conveniently be used to reconstitute and deliver a wide variety of medicaments in various selected doses. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0016]      FIG. 1  is a side elevational view, partly in cross-section showing one form of the vial accessing adapter subassembly of the invention for use in administering medicaments to a patient.  
         [0017]      FIG. 2  is a view is similar to  FIG. 1 , but showing the vial accessing adapter subassembly positioned over and interconnected with a conventional medicament container or vial that is shown in phantom.  
         [0018]      FIG. 2A  is an enlarged view similar to  FIG. 2 , but illustrating in cross-section the area designated in  FIG. 2  as  2 A.  
         [0019]      FIG. 3  is a view partly in cross section of the accessing adapter subassembly and the syringe body that can be operably interconnected with the accessing adapter subassembly to form the syringe assembly that is used to accomplish the fluid transfer steps.  
         [0020]      FIG. 3A  is a view similar to  FIG. 3 , but showing the syringe assembly separated from the adapter component of the accessing adapter assembly.  
         [0021]      FIG. 4  is a fragmentary cross-sectional view of an alternate form of the vial accessing adapter subassembly of the apparatus of the invention that includes filter means for filtering the fluid withdrawn from the medicament container.  
         [0022]      FIG. 4A  is a greatly enlarged, cross-sectional view taken along lines  4 A- 4 A of  FIG. 4 .  
         [0023]      FIG. 5  is a cross-sectional view of another form of the adapter component of the vial accessing adapter means of the invention that includes venting means for venting to atmosphere gases contained within the medicament container.  
         [0024]      FIG. 5A  is an enlarged, cross-sectional view of the area designated in  FIG. 5  as  5 A.  
         [0025]      FIG. 6  is a cross-sectional view of still another form of the vial accessing adapter means of the invention having an adapter component of a different configuration.  
         [0026]      FIG. 7  is a cross-sectional view of yet another form of the vial accessing adapter means of the invention having an adapter component that includes a circumferentially extending, neck-gripping bead.  
         [0027]      FIG. 8  is a cross-sectional view of yet another form of vial accessing adapter means for accessing a medicament container. 
     
    
     DESCRIPTION OF THE INVENTION  
       [0028]     Referring to the drawings and particularly to  FIGS. 1 and 2 , one form of the vial accessing adapter means of the invention for the aseptic administration of medicaments contained within a medicament container is there shown. The vial-accessing adapter means here comprises a vial accessing adapter subassembly  12  that includes an adapter component  14  that is preferably formed from a moldable plastic material. Adapter component  14  includes a body portion  15  having a tapered bore  15   a , a top wall  16  connected to the body portion and an adapter cannula  18  that is integrally formed with and extends from body portion  15 . A container connector means is also connected to top wall  16  and functions to removably interconnect the adapter component with a conventional medicament container MC ( FIG. 2 ). The container connector means of the present form of the invention here comprises a resiliently deformable skirt  20  that is integrally formed with and extends from top wall  16  in the manner shown in the drawings. As best seen in  FIG. 2 , when the adapter component is mated with the medicament container, skirt  20  telescopically receives and securely grips the upper portion of the medicament container in a manner such that adapter cannula  18  will completely pierce the rubber stopper RS of the container ( FIG. 2A ). Rubber stopper RS is secured in position within the upper portion of the container in a conventional manner by a crimp ring CR.  
         [0029]     As illustrated in  FIG. 2A , plastic adapter cannula  18  has a piercing extremity  18   a  and a lumen  18   b  that communicates with the interior of the medicament container MC when the adapter component is interconnected with the container in the manner shown in  FIG. 2A . In this regard, it is to be noted that skirt  20  is provided with a radially inwardly extending shoulder  20   a  and a plurality of circumferentially spaced slits  20   b  that enable the adapter component of the invention to be snapped over the upper portion of the medicament container MC to securely grip the container in the manner shown in  FIG. 2 .  
         [0030]     In the present form of the invention body portion  15  of the vial accessing adapter means functions to interconnect the syringe assembly  24  ( FIG. 3A ) of the apparatus of the invention with the-medicament container MC. As illustrated in  FIG. 3 , this important syringe assembly  24  is made up of an aspirator means shown here as syringe body  25  and an aspirator connector means, or syringe cannula assembly  26 , that can be sealably connected to body portion  15  of the vial accessing adapter means of the invention. The aspirator means or syringe body  25  includes a barrel portion  28  having a forward end  28   a  and a piston  30  that it is slidably carried within the barrel portion. As in conventional syringes, a liquid chamber  32  is formed between the forward end  28   a  of the barrel portion of the syringe body and piston  30 .  
         [0031]     Removably connected to the aspirator means or syringe body  25  is the previously mentioned aspirator connector means or syringe cannula assembly  26  that includes a syringe cannula support  41  and a syringe cannula  42  that is integrally formed with the syringe cannula support  41 . As best seen in  FIG. 2 , syringe or aspirator cannula  42  is here shown as a hypodermic needle having a lumen  42   a . As shown in  FIG. 3 , syringe cannula assembly  26 , which is removably connected to syringe body portion  25  of the syringe assembly, is sealably receivable within the tapered bore  15   a  of body potion. It is important to note that when the syringe cannula support  41  of the cannula assembly  26  is sealably connected to body portion  15  in the manner shown in  FIG. 2 , the syringe cannula or hypodermic needle  42  is stratigically positioned within lumen  18   a  of the adapter cannula  18  and is, therefore, protected from contamination, including contamination by the rubber stopper of the medicament container.  
         [0032]     The syringe cannula support  41  of cannula assembly  26  is also provided with barrel connection means for connecting the assembly with the forward end  28  of the barrel portion  26  of the syringe body  25 . This barrel connection means is here provided in the form of a conventional luer  48  formed on cannula support  41 . As shown in the phantom lines of  FIG. 3A , luer  48  is threadably receivable within internal threads  28   a  provided the forward end  28   b  of the barrel portion  28 . Once the syringe cannula assembly  26  is interconnected with the syringe body  25 , the syringe assembly  24  thus formed functions in the same manner as a conventional medicament administration syringe and, in the manner presently to be described, can be used to reconstitute lyophilized drugs and to administer medicaments to a patient in a conventional manner.  
         [0033]     It is to be understood that the medicament container MC can contain a fluid medicament, or, alternatively, can contain a medicament in a powdered or lyophilized form. As previously mentioned, when the medicament is a powdered or lyophilized form a suitable liquid diluent must be added to the container to reconstitute the powdered or lyophilized drug before use. In accordance with one form of the method of the present invention, this can be accomplished by first accessing the sealed container of powdered or lyophilized drug using the vial accessing adapter means that is made up of adapter  14  and syringe cannula assembly  26 . This accessing step is accomplished by placing the vial accessing adapter subassembly  12  over the medicament container MC and exerting a downward force on the subassembly sufficient to cause adapter cannula  18  to pierce the rubber stopper in the manner shown in  FIG. 2A . With the components in the position shown in  FIG. 2A , is to be observed that the lumen  18   a  of cannula  18  as well as the lumen  42   a  of piercing cannula  42  are in communication with the interior of medicament container MC.  
         [0034]     With the vial accessing adapter subassembly  12  appropriately interconnected with the medicament container MC, the assemblage thus formed is inverted and a sealed syringe body  25  that has been prefilled with a suitable diluent opened and is then connected to the vial accessing adapter means by means of the luer connector  48  formed on member  41 . The prefilled, sealed syringe body, which is typically readily available, off-the-shelf item, can be of various sizes and can contain various types of diluent. With the prefilled syringe body connected to the vial accessing adapter subassembly, a force exerted on plunger  30  will cause the diluent to controllably flow into the medicament container MC. The inverted medicament container is then shaken to thoroughly intermix the powdered or lyophilized drug with the liquid diluent. This done, the reconstituted drug can be drawn into the syringe assembly  24  by withdrawing the plunger  30  of the syringe body. The syringe assembly  24  and can then be removed from the adapter  14  and, the manner shown by the solid lines in  FIG. 3A , the syringe can be used to administer the reconstituted drug to the patient. It is to be appreciated that throughout this entire process, cannula or hypodermic needle  42  has been maintained in a sterile configuration. Only cannula  18  has pierced the potentially contaminated rubber stopper RS of the medicament container and cannula  42  has been completely protected against any possible contamination by the rubber stopper RS. Stated another way, during the entire process of reconstituting the powdered or lyophilized drug, cannula  42  has been maintained in a virgin, sterile configuration and is completely free from any possible contamination at the time of administration of the reconstituted drug to the patient.  
         [0035]     When the medicament to be delivered to the patient is contained within the medicament container and requires no reconstitution, the assembled syringe  24  can be mated with the adapter  14  and the assembly thus formed can be directly mated with the medicament container MC. In this instance, during the mating step, the skirt portion  20  of the adapter is snapped over the upper portion of the container and the cannula  18  is urged into piercing engagement the rubber stopper in the manner shown in  FIG. 2A  so as to open communication between lumen  42   a  of cannula  42  and the interior of the medicament container MC. The syringe assembly can then be used to withdraw the liquid medicament from the container into reservoir  32  of the syringe assembly. The syringe assembly can then be removed from the adapter  14  and used to inject the medicament within reservoir  32  into a patient in a conventional manner. It is to be understood that, if desired, the syringe cannula assembly can first be connected to the adapter  14  to form a container accessing subassembly comprising the syringe cannula assembly and the adapter  14 . The container accessing subassembly can then be mated with the medicament container so that the cannula  18  pierces the rubber stopper. This done, the syringe body can be mated with the container accessing subassembly and by sliding the piston outwardly of the syringe body, the medicament can be removed from the container.  
         [0036]     Turning next to  FIGS. 4 and 4 A, there is shown an alternate form of the vial accessing adapter means of the apparatus of the invention for the aseptic administration of medicaments contained within a medicament container. This alternate form of the invention is quite similar to the embodiment shown in  FIGS. 1 through 3  and like numerals are used in  FIGS. 4 and 4 A to identify like components. The primary difference between this latest form of the invention and the earlier described embodiment resides in the fact that a filter means, shown here as a porous filter  50 , is provided within lumen  18   a  of cannula  18 . Filter  50 , which can be constructed from any suitable porous metal or ceramic material, is strategically positioned between cannula  42  and the open-end  18   a  of cannula  18 . When positioned within cannula  18 , filter  50  functions to effectively filter out any particular matter that may reside within the liquid medicament contained within medicament container MC.  
         [0037]     Referring next to  FIGS. 5 and 5 A, an alternate form of vial accessing adapter means of the invention is there shown in generally designated by the numeral  40 . The vial accessing adapter means of this alternate form of the invention is somewhat similar to vial accessing adapter means of the embodiment of the invention shown in  FIG. 1 , but uniquely includes venting means for venting to atmosphere any gases that may reside within in the medicament container.  
         [0038]     As shown in  FIG. 5 , this alternate form of vial accessing adapter means includes an adapter component  44  that is preferably formed from a moldable plastic material. Adapter  44  includes a body portion  45  having a tapered bore  45   a  and a top wall  46  connected to the body portion. An adapter cannula  48  is integrally formed with and extends from body portion  45 . A container connector means is connected to top wall  46  for removably interconnecting the adapter component to a conventional medicament container MC, such as the container shown in  FIG. 2 . The container connector means of the present form of the invention here comprises a resiliently deformable skirt  50  that is integrally formed with and extends from top wall  46  in the manner shown in the drawings. When the adapter component is mated with the medicament container, skirt  50  telescopically receives and securely grips the upper portion of the medicament container in a manner such that adapter cannula  48  will completely pierce the rubber stopper of the container.  
         [0039]     As before, plastic adapter cannula  48  has a piercing extremity  48   a  and a lumen  48   b  that communicates with the interior of the medicament container when the adapter is interconnected with the container in the manner previously discussed herein. In this regard, it is to be noted that as in the earlier described embodiments, skirt  50  is provided with a radially inwardly extending shoulder  50   a  and a plurality of circumferentially spaced slits  50   b  that enable the adapter of the invention to be snapped over the upper portion of the medicament container to securely grip the container in the manner shown in  FIG. 2 .  
         [0040]     In this latest form of the invention cannula  48  is provided with a vent passageway  54  that also communicates with the interior of the medicament container. As best seen in  FIG. 5A , vent passageway  54  communicates with a transversally extending passageway  56  via a filter member  58 . Transversally extending passageway  56 , in turn, communicates with a vent port  60  formed in top wall  46  of the adapter  44 . The vent passageways  54  and  56 , along with vent port  60  comprises the venting means of the form of the invention shown in  FIGS. 5 and 5 A. With the construction shown in these figure drawings, after plastic cannula  48  has pierced the rubber stopper of the medicament container, gases within the container can flow to atmosphere in the direction of the arrows shown in  FIG. 5A  and thereby affectively vent the interior of the container to atmosphere.  
         [0041]     As before, body portion  45  functions to removably interconnect a syringe assembly of the character previously described and as shown in  FIG. 3A . As in the earlier described embodiments of the invention, the tapered bore  45   a  of body portion  45  is adapted to sealably receive the syringe cannula support  41  of the syringe cannula assembly  26 , or aspirator connector means, that comprises cannula support  41  and syringe cannula  42  that is connected to the syringe cannula support  41 . Once the aspirating means or syringe body  25  is interconnected with the syringe cannula support  41  in the manner previously described, the syringe assembly thus formed functions in the same manner as a conventional medicament administration syringe to reconstitute lyophilized drugs and to administer medicaments to a patient in a conventional manner.  
         [0042]     Turning to  FIG. 6 , still another, alternate form of the vial accessing adapter means of the invention is there shown in generally designated by the numeral  70 . The vial-accessing adapter means of this alternate form of the invention is also somewhat similar to that shown in  FIG. 1 , but uniquely comprises an adapter  72  that includes generally cylindrically shaped connector skirt  74 . Adapter  72  also includes a body portion  75  having a tapered bore  75   a , a top wall  76  connected to the body portion and an adapter cannula  78  that is integrally formed with and extends from body portion  75 . Connector skirt  74  is connected to top wall  46  and functions to removably interconnect the adapter component to a conventional medicament container such as the container MC shown in  FIG. 2 . When the adapter component is mated with the medicament container, skirt  74  telescopically receives and securely grips the upper portion of the medicament container in a manner such that adapter cannula  78  will completely pierce the rubber stopper of the container.  
         [0043]     As before, plastic adapter cannula  78  has a piercing extremity  78   a  and a lumen  78   b  that communicates with the interior of the medicament container when the adapter is interconnected with the container in the manner previously discussed herein.  
         [0044]     The tapered bore  75   a  of body portion  75  is adapted to removably receive the syringe cannula support  82  of the syringe cannula assembly that comprises cannula support  82  and syringe cannula  86  that is connected to the syringe cannula support  82 . Once the syringe body  25  is interconnected with the syringe cannula support  82  in the manner previously described, the syringe assembly thus formed functions in the same manner as a conventional medicament administration syringe to reconstitute lyophilized drugs and to administer medicaments to a patient in a conventional manner.  
         [0045]     Referring next to  FIG. 7 , yet another, alternate form of the vial accessing adapter means of the invention is there shown in generally designated by the numeral  90 . The vial accessing adapter means of this alternate form of the invention is quite similar to that shown in  FIG. 6  and like numerals are used in  FIG. 7  to identify like components. The principal difference between the adapter means of the invention shown in  FIG. 7  and that shown in  FIG. 6  resides in the fact that the generally cylindrically shaped plastic skirt  92  of the adapter  93  is provided with a circumferentially extending protuberance  92   a . When the adapter of this alternate form of the invention is interconnected with the medicament container, protuberance  92   a  is lockably received proximate the neck of the medicament container MC and functions to hold the adapter in position relative to the medicament container.  
         [0046]     As in the earlier described embodiments, adapter  93  includes a top wall  96  and an adapter cannula  98  that is integrally formed with and extends from top wall  96 . Connector skirt  92  is also connected to top wall  96  and functions to removably interconnect the adapter component to a conventional medicament container such as the container shown in  FIG. 2 . When the adapter component is mated with the medicament container, skirt  92  telescopically receives the upper portion of the medicament container and protuberance  92   a  grips the neck of the container in a manner such that adapter cannula  98  completely pierces the rubber stopper of the container.  
         [0047]     As before, plastic adapter cannula  98  has a piercing extremity  98   a  and a lumen  98   b  that communicates with the interior of the medicament container when the adapter is interconnected with the container in the manner previously discussed herein.  
         [0048]     Adapter  93  includes a body portion  94  to which the top wall  96  is connected, the body portion having a tapered bore  94   a . Cannula  98  is integrally formed with and extends from body portion  94  so that when the adapter component is mated with the medicament container, the adapter cannula pierces the stopper of the medicament container. Skirt  92  telescopically receives and securely grips the upper portion of the medicament container and as in the earlier described embodiments of the invention, the body portion  94  functions to sealably receive a syringe cannula support  82  which is identical in construction and operation to that previously described.  
         [0049]     Turning lastly to  FIG. 8 , still another form of vial accessing adapter means of the invention for the aseptic administration of medicaments contained within a medicament container is there shown and generally designated by the numeral  101 . This latest form of the invention includes an adapter component  102  that is somewhat similar to the adapter  14  shown in  FIG. 1 , but does not include either a top wall or a resiliently deformable skirt for gripping the medicament container. Rather, the adapter component  102  includes only a generally cylindrically shaped body portion  104  that is similar in configuration to the previously described adapter body portions. This generally cylindrically shaped body portion  104  of adapter  101  is provided with a tapered bore  104   a  that is adapted to sealably receive a syringe cannula support  108  to which a syringe cannula  110  of a syringe cannula assembly  111  is connected. Connected to and depending from body portion  104  is an adapter cannula  106  having a piercing extremity  106   a  that is adapted to pierce the rubber stopper of a conventional medicament container. As shown in  FIG. 8 , adapter cannula  106  has a lumen  106   b  that is in communication with bore  104   a  of body portion  104 .  
         [0050]     Once again, it is important to note that when the syringe cannula support  108  of the aspirator connector means is sealably received within tapered bore  104   a  of body portion  104  in the manner shown in  FIG. 8 , the syringe cannula or hypodermic needle  110  is once again strategically positioned within lumen  106   b  of the adapter cannula  106  and is therefore protected from contamination. Once the syringe cannula assembly  111  is interconnected with an aspirating means, such as the earlier described syringe body  25  ( FIG. 3 ), the syringe assembly thus formed functions in the same manner as a conventional medicament administration syringe and can be used to reconstitute lyophilized drugs and to administer medicaments to a patient in the manner previously described herein.  
         [0051]     In accordance with an alternate form of the method of the invention for reconstituting a powdered or lyophilized drug, the sealed container containing the drug is first accessed using the vial accessing adapter subassembly  101 , which is of the character shown in  FIG. 8 . This accessing step is accomplished by exerting a force on the subassembly  101  that is sufficient to cause adapter cannula  106  to pierce the rubber stopper so that the lumen  106   b  of cannula  106  as well as the lumen  110   a  of cannula  110  are in communication with the interior of medicament container.  
         [0052]     With the vial accessing adapter subassembly  101  appropriately interconnected with the medicament container, the assemblage thus formed is inverted and a sealed syringe body, such as syringe body  25  that has been prefilled with a suitable diluent is opened and is then connected to the vial accessing adapter subassembly  101  by means of the luer connector  108   a  formed on connector member  108 . As before, the prefilled, sealed syringe body  25 , or aspirator means, which is typically readily available, off-the-shelf item, can be of various sizes and can contain various types of diluent. With the prefilled syringe body connected to the vial accessing adapter subassembly  101 , a force exerted on the plunger of the syringe will cause the diluent to controllably flow into the medicament container. The inverted medicament container is then shaken to thoroughly intermix the powdered or lyophilized drug with the liquid diluent. This done, the reconstituted drug can be aspirated into the syringe assembly by withdrawing the plunger of the syringe body. The syringe assembly can then be removed from body  104  and the syringe can be used to administer the reconstituted drug to the patient. It is to be appreciated that throughout this entire process, cannula or hypodermic needle  110  has been maintained in a sterile configuration. Only cannula  106  has pierced the rubber stopper of the medicament container and cannula  110  has been completely protected against any possible contamination by the rubber stopper of the medicament container.  
         [0053]     When the medicament to be delivered to the patient is contained within the medicament container and requires no reconstitution, an assembled syringe, such as syringe  24  can be mated with body  104  of adapter  102  and the assembly thus formed can be directly mated with the medicament container. In this instance, during the mating step, the cannula  106  is urged into piercing engagement the rubber stopper so as to open communication between lumen  106   b  of cannula  106  and the interior of the medicament container. The syringe assembly can then be used to withdraw the liquid medicament from the container into the reservoir of the syringe assembly. The syringe assembly can then be removed from body  104  and used to inject the medicament within reservoir into a patient in a conventional manner.  
         [0054]     Having now described the invention in detail in accordance with the requirements of the patent statutes, those skilled in this art will have no difficulty in making changes and modifications in the individual parts or their relative assembly in order to meet specific requirements or conditions. Such changes and modifications may be made without departing from the scope and spirit of the invention, as set forth in the following claims.