Patent Publication Number: US-11376195-B2

Title: Syringe devices and methods for mixing and administering medication

Description:
RELATED PATENT DATA 
     This patent application is a continuation of U.S. patent application Ser. No. 13/549,380 which was filed on Jul. 13, 2012, which is a continuation of U.S. patent application Ser. No. 14/751,410 which was filed on May 21, 2007, now U.S. Pat. No. 8,231,567 issued Jul. 31, 2012, which is a divisional application of U.S. patent application Ser. No. 11/238,880, which was filed on Sep. 28, 2005, now U.S. Pat. No. 7,731,678 issued Jun. 8, 2010, which claimed priority under 35 U.S.C. § 119 to U.S. Provisional Patent Application Ser. No. 60/670,413, which was filed Apr. 11, 2005, and to U.S. Provisional Patent Application Ser. No. 60/618,639, which was filed Oct. 13, 2004, the entirety of each of which is incorporated by reference herein. 
    
    
     TECHNICAL FIELD 
     The method pertains to syringe devices, piercing structures, medication agent preparation systems, mixing and administration systems, methods of mixing components, and methods of preparing a medication agent for administration to an individual. 
     BACKGROUND OF THE INVENTION 
     Preparation of medicants or medication agents and administration of such agents to an individual often involves mixing of two or more components to form the agent and subsequent delivery of the mixed medicant to the individual. The mixing of components can typically involve extraction of one component in fluid form from a vial or other container and transfer of such components into a separate container which holds another component. In particular instances, only a portion of the contents of a vial or container is to be utilized for preparing a mixture prior to administering. Accordingly, the extraction and transfer can involve precise measuring of one or more components to be mixed. 
     A variety of problems may occur when utilizing conventional methodology and devices for mixing and/or administering medicants to an individual. For example, where multiple components are to be mixed, extraction and transfer of one component and introduction of such component into another component can potentially expose one or both of the components to a non-sterile or contaminated environment leading to contamination of the resulting medicant. Additionally, incomplete extraction or improper measurement of one or more components can result in preparation and/or administration of an improper dosage. In particular instances, once a medicant is mixed the mixture must again be extracted from a vial or container into a syringe prior to administering to an individual. Such additional transfer can lead to additional opportunities for contamination, incomplete extraction of contents and/or inaccurate measuring of a component or the resulting medicant. In practice, there is limited availability of sterile environments for maintaining sterility during transfer and/or mixing of components, or preparation and transfer of medicants. Additional errors can result from use of the wrong diluent to reconstitute the medication. Finally, preparation of medicants utilizing multiple components can be tedious and time consuming due to factors such as the need to access individually packaged items such as separate vials and/or transfer devices, or to measure one or more components to be combined to form the medicant. 
     It would be desirable to develop alternative methodology and systems for preparation and administration of medicants. 
     SUMMARY OF THE INVENTION 
     In one aspect the invention encompasses a syringe device. The device includes a syringe body having a cylindrical housing and a chamber within the housing. The device additionally includes a piston having a stem, a first end and a second end opposing the first end. The first end is external to the chamber comprised by the syringe body. A fluid passageway extends through the first end through the stem and through the second end of the piston. The syringe device further includes a valve which is associated with the fluid passageway through the piston such that the valve controls selective fluid passage through the piston. A cap can be reversibly attached to the syringe body to provide a fluid seal. 
     In one aspect the invention encompasses a piercing structure having a head segment comprising a tip disposed at a first end of the structure. The head has a front surface and an opposing back surface. The piercing structure additionally includes a body portion comprising a base surface disposed at a second end opposing the first end of the structure. A fluid passageway passes through the second end of the structure through the body portion and through at least one of the front surface and the back surface of the head without passing through the tip. 
     In one aspect the invention encompasses a medication agent preparation system. The system comprises a syringe having a barrel with an internal chamber, and a piston having a first end, a second end and a fluid passageway passing longitudinally through the piston. At least a portion of the piston comprising the first end is inserted into the chamber. A piercing structure having a fluid channel is associated with the second end of the piston. A vial is disposed proximate and moveable relative to the tip of the piercing structure. A first component of a medication agent is disposed within the internal chamber of the syringe barrel and second component of the medication agent is disposed within the vial. A valve is associated with the fluid passageway which passes through the piston. 
     In another aspect the invention encompasses a method of preparing a medication agent for administration to an individual. The method includes providing a syringe having a syringe barrel and a piston disposed at an initial position relative to the syringe barrel. A first component is provided within the syringe barrel and a second component is provided within a vial. A valve is associated with a fluid passageway between the vial and the syringe barrel with the valve initially being disposed in a closed position, blocking fluid passage through the passageway. The method includes repositioning the valve to allow fluid passage between the vial and the syringe barrel. After repositioning the valve, the piston is slid in a first direction to join the first component with the second component. The first and second components are mixed to produce the medication agent. Mixing can be facilitated by agitating, inverting the device and/or repeated sliding of the piston in opposing directions. The method further includes drawing the medication agent into the syringe barrel. 
     In an additional aspect the invention includes a method of preparing a composition. A packaging material is provided containing a mixing device in which the mixing device includes a housing having a chamber therein containing a first material. The device also includes a piston slideable within the chamber with the piston having a length that is greater than the length of the chamber. The mixing device further includes a container holding a second material. A fluid passageway is disposed longitudinally through the piston with a valve being associated with the fluid passageway. Without exposing the device to an environment external to the packaging material the valve is repositioned from a closed position to an open position. With the valve in the open position the piston is slid in a first direction from a first position within the chamber to a second position within the chamber. The sliding of the piston moves one of the first and second components through the piston. The first and second materials are then mixed to form a mixture where the mixing comprises sliding the piston in a second direction and subsequently returning the piston in the first direction. The mixture is then drawn into the chamber through the piston. 
     In one aspect the invention encompasses a medicant preparation device. The device includes a syringe barrel which has a first end, a second end and a longitudinal axis therebetween. A piston is insertable with the syringe barrel through the second end with the piston being slideable within the barrel. The device further includes a vial containing a material and an adapter component. The adapter component includes a vial housing portion configured to reversibly receive a vial. The adapter also has a fitting configured to attach to the syringe at the first end. A first fluid passageway extends through the fitting to a valve, and a second fluid passageway extends from the valve to the vial housing. The medicant preparation device additionally includes packaging which is configured to allow manipulation of the valve and sliding of the piston without opening of the package. 
     In a general aspect, the invention includes a device comprising a housing around a chamber, a piston having a first end, a second end and a fluid passageway between the first and second end with the piston being insertable into the chamber. The device also includes a valve associated with the fluid passageway such that flow through the fluid passageway is selectively regulated by the valve. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Preferred embodiments of the invention are described below with reference to the following accompanying drawings. 
         FIG. 1  is a side view and partial cross-sectional view of a mixing assembly in accordance with one aspect of the invention. 
         FIG. 2  is an exploded side view of the assembly shown in  FIG. 1 . 
         FIG. 3  is a side view of a portion of a syringe device in accordance with one aspect of the invention. 
         FIG. 4  is a side view of a syringe piston in accordance with one aspect of the invention. 
         FIG. 5  is a perspective view of an exemplary valve according to one aspect of the invention. 
         FIG. 6  is a fragmented perspective view of a syringe piston in accordance with one aspect of the invention. 
         FIG. 7  is a perspective view of a piercing device in accordance with one aspect of the invention. 
         FIG. 8  is a side view of a container which can be utilized in one aspect of the invention. 
         FIG. 9  is a fragmentary side view and partial cross-sectional view of a portion of a mixing assembly as illustrated in  FIG. 1 . 
         FIG. 10  is a fragmentary perspective view of a portion of the mixing assembly illustrated in  FIG. 1 . 
         FIG. 11  is an exploded perspective view of a mixing assembly in accordance with an alternate aspect of the present invention. 
         FIG. 12  is an exploded perspective view of a mixing assembly in accordance with another alternate aspect of the invention. 
         FIG. 13A  illustrates an extension housing from a perspective view and  FIG. 13B  illustrates an extension housing end view in accordance with the aspect shown in  FIG. 12 . 
         FIG. 14  shows a side view of a mixing device having an integral housing configuration in accordance with one aspect of the invention. 
         FIG. 15A  is a side view of an alternate embodiment of a piston in accordance with one aspect of the invention. 
         FIG. 15B  is an exploded view of the piston structure shown in  FIG. 15A . 
         FIG. 15C  is an exploded cross-sectional fragmentary view of the piston structure shown in  FIG. 15A . 
         FIG. 15D  is a cross-sectional fragmentary sideview of the piston structure shown in  FIG. 15A . 
         FIG. 16A  is a side view and partial cross-sectional view of a mixing assembly in accordance with an alternative aspect of the invention. 
         FIG. 16  B is a side and partially cross-sectional view of an adapter portion of the assembly shown in  FIG. 16A  shown in association with an exemplary vial. 
         FIG. 17  is a perspective view of an alternate mixing assembly in accordance with one aspect of the invention. 
         FIG. 18A  is an exploded view of another alternate embodiment of a device in accordance with the invention. 
         FIG. 18B  is an exploded fragmentary partially cross-sectional view of the device shown in  FIG. 18A . 
         FIG. 18C  is a fragmentary partially cross-sectional view of the device shown in  FIG. 18A . 
         FIG. 19  is a perspective view of a mixing assembly and exemplary packaging in accordance with one aspect of the invention. 
         FIG. 20  shows an additional packaging and labeling aspects in accordance with the invention. 
         FIG. 21  shows a device and packaging in accordance with an alternate aspect of the invention. 
         FIG. 22  shows a packaging configuration for a particular aspect of the invention. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     This disclosure of the invention is submitted in furtherance of the constitutional purposes of the U.S. Patent Laws “to promote the progress of science and useful arts” (Article 1, Section 8). 
     In general, the invention provides methodology for combining and mixing to produce a mixture and encompasses device configurations to allow combination and mixing of components. In particular, methodology of the invention involves combining and mixing components to produce an administration-ready agent such as a medicant and, in particular aspects, includes administering such agent to an individual. Accordingly, device configurations of the invention allow combination of separate components such that the combined and mixed components are administration-ready. In particular aspects the encompassed devices are additionally configured for use during administration of the administration-ready agent. The general concepts and exemplary devices in accordance with the invention are illustrated in the accompanying  FIGS. 1-22 . 
     Where devices in accordance with the invention are used for preparation of a medicant, the devices are preferably closed-system mixing assemblies. An exemplary mixing assembly  10  in accordance with the invention is illustrated in  FIG. 1 . The various components of the mixing assembly  10  are described generally with reference to  FIG. 1  and will be described in greater detail with reference to subsequent figures. It is to be understood that the general features described with reference to  FIG. 1  are exemplary and the invention encompasses modifications, alternate embodiments and adaptations including but not limited to those specifically illustrated in subsequent drawings. 
     Mixing assembly  10  can comprise a container such as a syringe body (or barrel)  100  and a piston  200  which has a fluid passageway passing entirely through the length of the piston (discussed further below). In some instances, a reversibly attached cap (not shown) may be present providing a fluid seal at a forward end of the syringe body. A valve  300  can be associated with piston  200  and can preferably be configured to allow selective fluid passage through the piston passageway. The mixing assembly can have an extension  600  which can comprise a cylindrical or alternatively shaped housing configured to receive a vial  500  or alternative second container within a chamber or opening within the extension. Assembly  10  can further comprise a puncturing device  400  associated with piston  200 . Although  FIG. 1  and subsequent figures depict assemblies as comprising syringes and the description presents methodology primarily in terms of preparing a medicant, it is to be understood that the invention encompasses alternative container shapes and adaptation of devices for use in mixing of components to form mixtures or agents other than medicants. 
     As illustrated in  FIG. 1 , a vial  500  which can be, for example, a standard medicant type vial, can be utilized and extension housing  600  can preferably be configured such that vial  500  is slideably insertable into an internal area of housing  600 . 
     A mixing and administration system comprising mixing assembly  10  as illustrated in  FIG. 1  can be described as being a closed-system in that separate components of an agent can be combined and mixed without exposing the components to an environment external to the mixing assembly. For example, a first component can be provided within vial  500  and a second component can be provided within syringe  100 . Syringe  100  can be capped to retain the second component, with such cap being reversibly attached to allow removal as appropriate (described below). 
     As described in greater detail below, the fluid passageway through piston  200  preferably extends longitudinally and more preferably along the longitudinal axis from a first end of the piston stem through the piston and out a second end such that fluid communication can be established between vial  500  and the chamber of syringe  100 . Accordingly, when valve  300  is positioned in an “open configuration” bi-directional fluid flow through the piston passageway is established allowing fluid communication between the syringe barrel (preferably capped) and vial  500 . 
     Referring to  FIG. 2 , such shows an exploded view of the various general components of mixing assembly  10 . Such view illustrates the general relationship of the various components, each of which is described independently in subsequent figures. Primarily it is noted with reference to  FIG. 2  that piston  200  can comprise an independently fabricated seal or stopper portion  208  and that each of valve  300  and piercing structure  400  can be fabricated independently of the rod or stem portion of the piston. However, it is to be noted that the invention contemplates alternative aspects where one or more of stopper  208 , valve  300  and piercing structure  400  are integral with the stem portion of the piston. It is to be additionally noted that extension  600  as depicted in  FIG. 2  having an open end for receiving vial  500  can be fabricated to be independent of piston  200  as illustrated, or can be fabricated to be integral with the piston stem portion (not shown). 
     Referring to  FIG. 3 , syringe body  100  can comprise a cylindrical housing  102  having an interior region or chamber  104  within the housing. The chamber can be described as having a longitudinal axis extending from a first end  105  of the syringe body. A second end  106  of the syringe body is disposed opposing first end  105 . In particular instances, the syringe can comprise a LUER-LOK® (Becton, Dickinson and Company, Corp., Franklin Lakes, N.J.) type fitting  108  disposed proximate the second end as illustrated in  FIG. 3 . Although a Luer-Lok connector is illustrated it is to be understood that the invention contemplates alternative connector/fitting configurations. Preferably, connector  108  is able to receive and preferably reversibly receive a needle, alternative cannula, tubing and/or adaptors which can be utilized, for example, during administering of a medicant from within chamber  104  to an individual or in particular instances, for transferring into a distinct container (not shown). In particular applications it can be preferable that syringe body  100  comprise a male Luer-Lok type fitting to allow connection and preferably reversible connection with a female Luer-Lok fitting comprised by an administration needle. 
     Syringe housing  102  can have volume markings such as those illustrated, or can have alternative volume indicators to assist in measuring or verifying volume. Although not specifically illustrated in  FIG. 3 , a cap can be provided to seal second end  106  (see  FIG. 19 ). The cap can prevent fluid passage from within the syringe barrel during storage, shipping, mixing, etc., and can prevent exposure of medicant components to an environment external to the syringe device. The cap can be configured to be reversibly attached by Luer-Lok or other fitting mechanism, to allow removal and replacement by an appropriate administration or transfer attachment. 
     Syringe body  100  can be a conventional type syringe barrel or can be manufactured for a particular application in accordance with the invention. The housing can be fabricated to comprise for example medical grade/approved glass or plastic material(s). Exemplary materials which can be utilized for syringe housing formation include but are not limited to polyethylenes, polypropylenes, polycycloolefins, polyvinyl chloride (PVC), polyamides (including aliphatic and aromatic variants), polyesters, polycarbonates, copolymer materials including but not limited to those containing ethylene-diene-propylene monomer (EPDM), polyacrylates, polyurethanes, composites, blends or combinations of such materials, or alternative composite materials. 
     The volume of the syringe (or alternate container) is not limited to a particular value and the syringe body can be configured to contain a maximum volume of, for example, from 1 ml to greater than 10 ml. Preferably the syringe volume will be less than or equal to 10 ml. For purposes of the present description, the syringe volume refers to the volume of liquid which the syringe housing is configured to retain and not the overall volume within internal region  104 . 
     Referring next to  FIG. 4 , an exemplary piston  200  is illustrated having a stem portion  201 , a first end  204  and a second end  202 . The piston can be described as having a length represented by d 1  extending from first end  204  to second end  202 . The length d 1  is not limited to a particular value and can preferably be a value greater than the length the longitudinal axis of internal syringe chamber  104 . 
     A fluid pathway  206  traverses the length of the piston as illustrated by dashed lines. The diameter of fluid pathway  206  is represented in  FIG. 4  by “d 2 ”. In some instances pathway  206  can have a non-uniform diameter, however d 2  as used herein, indicates the minimum diameter of the passageway. Although d 1  and d 2  are not limited to particular values, it can be preferable in some instances that the ratio of d 1  to d 2  be at least about 10:1. Capillary action can be promoted by maximization of the aspect ratio of passage length to diameter. Such capillary action can assist in creating an airlock within the passage when an associated valve is in a closed position, thereby avoiding contact of a liquid component/diluent, with the valve prior to opening of the valve at initiation of a mixing event (discussed below). However, smaller ratios can advantageously allow the entirety of the piston stem to be manufactured as a single piece by, for example, injection molding techniques. Accordingly the invention contemplates alternate d 1  to d 2  ratios (i.e. less than about 10:1). 
     As illustrated in  FIG. 4 , a stopper portion  208  can be provided to be received onto second end  202  of piston  201 . In contrast with conventional syringe plungers, stopper portion  208  can be configured to have an opening or channel  210  passing entirely through the stopper allowing fluid passage from within passage  206  through stopper  208 . Although a single channel  210  is depicted, the invention contemplates stopper configurations having a plurality of channels providing fluid passage through the stopper to/from the passage through the piston stem. As depicted in  FIG. 1 , piston  200  is configured such that second end  202  is receivable within the syringe chamber such that fluid communication can be established between the syringe chamber and piston passageway  206  through stopper  208  via opening(s)  210  as illustrated in  FIG. 4 . 
     Where stopper  208  is formed as an independent structure relative to the piston stem, the stopper can preferably comprise a relatively soft material (with respect to the piston, discussed below). Exemplary materials which can be appropriate for fabrication of the stopper based upon manufacturability, biocompatibility and/or chemical compatibility, and ability to produce a fluid seal include elastomeric materials such as rubber, butyl, silicones, silanes, polypropylene, polypropylene-EPDM, polyurethanes, and other appropriate plastics, as well as various copolymers, blends and combinations thereof. 
     Referring again to  FIG. 4 , piston  210  can additionally comprise various supporting rings  212 ,  216  and  217 . It is to be understood that such rings are an optional feature and that stem portion  201  can be fabricated to comprise fewer rings than that depicted, to comprise none of the rings depicted, or to comprise additional rings relative to those depicted. The ring structures can additionally be alternately positioned along the piston stem relative to the positioning shown. In embodiments wherein stopper  208  is an independently formed structure, at least two of rings  212  are provided for mounting, positioning and retaining the stopper upon the piston. Ring structures  212 ,  216  and  217  can be advantageous, for example, for stabilizing and/or maneuvering piston  200  and to assist in reducing or avoiding contamination of internal syringe body surfaces during syringe manipulation, especially for embodiments where packaging is removed prior to manipulation of the mixing assembly (discussed below). 
     As additionally illustrated in  FIG. 4 , piston  200  can comprise an opening  214  extending through piston stem  201 . Such opening can preferably orthogonally intersect fluid passageway  206 . Such opening can be configured to allow insertion of a valve such as the exemplary valve depicted in  FIG. 5 . The depicted positioning of opening  214  along the length of piston stem  201  of  FIG. 4  is exemplary. The positioning of valve opening  214  is not limited to any particular location and can be anywhere along the length of fluid path  206 . It can be preferable in some instances that valve insertion opening  214  be positioned at the halfway point along distance d 1 , or alternately to be more proximate end  204  than to end  202 . This positioning can advantageously allow ease of manipulation of the associated valve. 
     As depicted in  FIG. 1  assembly  10  can be configured such that valve  300  is, when disposed in association with opening  214 , at least partially insertable within syringe housing  100 . However the invention contemplates positioning of valve  300  more proximate end  204  than that depicted, especially for small volume syringes where a valve such as exemplary valve  300  shown is too large to fit insertably within the syringe housing. It is to be understood that alternative valve types can be utilized which can allow insertion or partial insertion of the valve into the syringe housing even for very small volume syringes. 
     Exemplary valve  300  is shown in greater detail in  FIG. 5 . As illustrated, valve  300  has a body portion  302  and a head portion  304 . Head portion  304  can be configured to have extension or protrusion tabs  307  and  308 . Although  FIG. 5  depicts two extension tabs it is to be understood that fewer or greater than two extension tabs can be utilized. Extension tabs  307  and  308  can advantageously assist proper positioning and alignment of a fluid passageway  306  which passes through stem portion  302  of valve  300 . The invention additionally contemplates alternative shapes for head portion  304  relative to the round configuration depicted. For example, the head portion can be arrow-shape to allow visual and/or tactile indication of valve position. Head portion  304  can also be configured to have alternative or additional visual and/or tactile indicators. 
     Valve body  302  is preferably configured to allow insertion of such portion into, and in particular instances entirely through, opening  214  of piston  200  as illustrated in  FIG. 4 . Accordingly, and as illustrated in  FIG. 5 , one or more seal or o-ring  310  can be provided to provide a fluid seal within opening  214 . Alternatively, a seal can be formed as an integral part of valve body  302  (not shown). Although opening  214  and the associated valve  300  are illustrated as being configured such that the valve passes entirely through piston stem  201 , it is to be understood that the invention contemplates alternative configurations where opening  214  and an associated valve, span less than an entirety of the cross-section of piston stem  201  (not shown). Additionally, although  FIG. 5  shows a two-way (on/off) stopcock type valve, the invention contemplates alternative valve types and appropriate opening configurations. For example, rather than the uniform-diameter cylindrical valve opening depicted, opening  214  can be configured to be conical, rectangular, or other shape. In such instances, valve body  302  can be appropriately shaped to be received within the opening. Alternative valve types such as bi-directional stop valves, slider-type valves, ball valves, push valves, or gate valves can be utilized and can be appropriately configured based upon the dimensions of opening  214 . 
     In addition to the single piece piston stem  201  illustrated in  FIG. 4  the invention contemplates utilization of multipart piston stems. Referring to  FIG. 6 , an exemplary two part piston stem  201  is illustrated having a first portion  230  and a second portion  232 . In the exemplary two-part piston stem illustrated parts  230  and  232  interface at the longitudinal position of opening  214  along the piston axis. Parts  230  and  232  can be joined by, for example, thermal welding, ultrasonic welding, radio-frequency welding, adhesive bonding or other appropriate bonding techniques. Alternatively, the two portions can be configured to snap together or can be secured by various joining structures such pins, clevises, threads or alternative mechanical attachment techniques known in the art or yet to be developed. 
     Although the two part piston stem illustrated depicts an interface between the two parts coinciding with the position of valve receiving opening  214  it is to be understood that the positioning of the interface is not limited to any particular location and can be, for example, anywhere along the longitudinal length of the piston stem. Appropriate positioning of the interface and length of the resulting segments can be adapted as appropriate based on ease of manufacture of an appropriate valve and piston segments. The invention additionally contemplates multi-part piston stems having more than two independently manufactured segments (not shown). 
     The piston and the syringe housing portions of the devices of the invention can typically comprise standard materials utilized for conventional syringe and piston/plunger formation. Typically, the piston, exclusive of the stopper, will be a relatively hard plastic. In embodiments where the stopper is integral with the piston, the integrated piece may be formed of a common plastic material. Exemplary plastics which can be utilized for piston formation include but are not limited to polyethylenes, polypropylenes, polycycloolefins, polyvinyl chloride (PVC), polyamides (including aliphatic and aromatic variants), polyesters, polycarbonates, polyacrylates, polyurethanes, copolymers, blends, composites, and combinations thereof. 
     Valve  300  is also not limited to a particular material and can preferably comprise plastic and/or elastomeric materials. In particular applications it can be preferable that valve body portion  302  (as illustrated in  FIG. 5 ) comprises an elastomeric material to allow a better fit and/or seal within the opening  214  of piston stem  201 , especially where piston  200  comprises a hard plastic material. Exemplary elastomeric materials which can be utilized for body portion  302  include but are not limited to polyurethanes, polypropylene-EPDM, other polypropylenes, polysiloxane and/or silicone materials, butyl materials, isoprenes, neoprenes, polyethylenes, and various copolymers, composites, blends or other combinations of such materials. Additional appropriate materials may include natural rubbers, nitrile rubbers and combinations thereof. Valve  300 , exclusive of o-ring  310 , can be constructed as a single piece and therefore can be formed of a particular material or type of material. Alternately, head portion  304  can be formed independently and comprise a material that differs from body portion  302 . For example, in particular instances head portion  304  can be formed of a hard plastic such as any of those listed above and body portion  302  can comprise either a distinct hard plastic material or any of the elastomeric materials listed above. 
     Referring to  FIG. 7 , such shows an exemplary piercing structure  400  in accordance with the invention. Piercing structure  400  can be described as having a head segment  401  comprising a tip  402  disposed at a first end. Piercing structure  400  additionally has a stem/body portion  403  extending from head portion  401  to a base surface  404  disposed at a second end of the structure opposing the first end. A channel  406  or other fluid passageway extends through the base surface and preferably through an entirety of body portion  403 . 
     The piercing structure  400  shown in  406  illustrates an exemplary shape and form of head segment  401 . As illustrated, head portion  401  can have an external surface comprising a front surface  414  (or upper surface as illustrated) and an opposing back surface  415 . In a preferred aspect of the invention channel  406  extends less than an entirety of an internal length of head segment  401  such that the channel does not pass through tip  402 . Rather, one or more access holes  408  are provided, for example, through one or both of surfaces  414  and  415 . Such configuration where the channel does not pass through the tip can advantageously minimize or prevent coring of the septum material or plugging of the channel during a piercing operation. 
     Access holes  108  can be disposed orthogonal relative to the longitudinal axis of channel  406  as depicted in  FIG. 7  or can intersect channel  406  at an angle of other than 90° (not shown). Additionally, the placement of holes  408  along head segment  401  is not limited to the position shown. It can be advantageous for holes  408  to be disposed proximate the body portion of the piercing device to allow such holes to lie just within a vial upon piercing. Such can maximize fluid access allowing efficient and complete extraction of vial contents without repositioning of the piercing structure after piercing of a septum or other barrier material. 
     To assist in puncturing and passing of head segment  401  through a punctured material such as, for example, a septum, head portion  401  can be configured to have one or more edges  410  and  412  be cutting edges, where the term “cutting edge” refers to an edge having a sharpness sufficient to cut the material being pierced during a piercing operation. As illustrated in  FIG. 7 , cutting edges  410  and  412  can preferably be disposed at the edges of head portion  401  where surfaces  414  and  415  meet. Although the figure illustrates two cutting edges it is to be understood that the invention contemplates configurations of head portions  401  which have no cutting edges, one cutting edge or more than two cutting edges. As further illustrated, one or both of surfaces  414  and  415  can be beveled. Such surface beveling can additionally aid in passing of head segment  401  through a punctured material. 
     Body portion  403  of piercing structure  400  can be, for example, cylindrical as illustrated in  FIG. 7 . Body portion  403  can have a uniform circumference throughout its length (not shown) or can have segments which vary in circumference relative to one another. For example, as illustrated in  FIG. 7  body portion  403  can have a tube segment  416  and a base segment  418  where base segment  418  extends from base surface  404  to tube segment  416 . The lengths of segments  418  and  416  are not limited to any particular values. Nor is the ratio of segment lengths limited to a particular value. Preferably, where base portion  418  will be seated within another component of a mixing assembly in accordance with the invention (such as piston  200 ), the length of segment  418  can be such to allow stabilization and/or retention of piercing structure  400  in the seated position. 
     Base portion  418  is preferably of sufficient length and appropriate shape to be securely seated within a seating opening comprised by the piston (see below). An o-ring or raised portion of base  418  (not shown) can be provided to allow a tight fitting. Accordingly, an appropriate indentation or groove (not shown) can be provided within the seat opening of the piston. In particular instances, a press fit or friction fit will be utilized for providing sufficient retention of the piercing structure. Secure joining may optionally be utilized utilizing for example, an adhesive, welding, or other appropriate joining technique. 
     With respect to segment  416 , such can preferably be of sufficient length to pass entirely through a punctured material to allow fluid passage across the punctured material via access hole  408  and through passageway  406 . Accordingly, an appropriate length of segment  416  can be determined by the thickness of a septum or other barrier to be punctured, while positioning access hole  408  as near the punctured material as possible to allow maximum fluid access (discussed above). Further, although the piercing device is not limited to a particular shape, the “arrowhead” shape configuration depicted in  FIG. 7 , where head segment  401  has ridge surfaces  409  which extend laterally outward relative to tube segment  416 , can assist in stabilizing and retaining the piercing device across a septum after puncturing has occurred. Retention of the piercing device across the septum can avoid inadvertent contact of the device by an individual which could cause injury and/or contamination of the medicant. 
     Numerous appropriate materials are available for fabrication of piercing device  400 . Such materials include but are not limited to metals, such as stainless steel, and various plastics such as polyamides, polyacrylates, polycarbonates, epoxies, polyurethanes, polysulfones, polytherimides, polypropylenes, copolymers, etc., in either thermoplastic or thermoset varieties. 
     In addition to the piercing structure depicted in  FIG. 7 , and variations of such configuration, the invention contemplates utilization of alternate structures to puncture a container barrier. Piston  200  can be adapted accordingly. Alternate structures can include, for example, a needle or a non-coring piercing structure of alternative shape relative to the arrowhead design depicted. Such alternative configurations can be especially useful where multiple vials are to be accessed sequentially (i.e. during preparation of a medicant comprising three or more components). 
     An exemplary vial  500  which can be utilized as part of a mixing assembly in accordance with the invention is illustrated in  FIG. 8 . For purposes of the invention, the term “vial” is not limited to a particular container structure and can be used to refer to various containers including containers utilized for parenteral as well as non-parenteral materials. Vial  500  can be, for example, a bottle such as illustrated in  FIG. 8  having a cap portion  504  and an upper surface  502 . Vial  500  can be a glass bottle or alternatively can be a plastic container or other material utilized conventionally or yet to be developed for retaining and/or accessing a medicant or component thereof. 
     Referring to  FIG. 9 , such shows and exemplary engagement configuration of piercing structure  400  and vial  500 . In the illustration of engagement, devise  400  is illustrated as passing through a septum  506  within cap portion  504  of vial  500 . Accordingly, fluid access is provided from within vial  500  through access hole  408  into and through fluid passageway  406 . 
     An exemplary association of puncturing device  400  and a piston  200  in accordance with the invention is shown in  FIG. 10 . As illustrated, base portion  418  (shown in  FIG. 9 ) of the puncturing device is seated within a terminal portion of passageway  206  of piston stem  201 . Such terminal portion can preferably be diametrically enlarged relative to other portions of passageway  206  to allow seating of the piercing structure.  FIG. 10  additionally illustrates an exemplary fitting  203  and ridge  205  present at the first end  204  of the piston structure. As illustrated, fitting  203  can have an interior area  207  having a base surface  213  with puncturing device  400  passing through such interior area and base surface. Although base surface  213  is illustrated as being flat, the invention contemplates seating configurations where a central portion of base surface  213  is raised within area  207  to form a pedestal or boss (not shown), where a central opening within the raised portion is an extension of the fluid passageway through the piston and is configured for seating the puncturing device. It can be advantageous to provide a raised portion to provide a space between base surface  213  and the top of vial  500 . The raised boss configuration can be adjusted to allow proper fitting and/or positioning of a particular vial within the receiving housing and association with the puncturing device. 
     Interior area  207  can be of sufficient size to allow a portion of a vial or container, such as cap portion  504  illustrated in  FIGS. 8 and 9  to be at least partially insertable within the fitting  203 . Additionally, fitting  203  can have an outer diameter of an appropriate size to allow insertion of fitting  203  within an extension structure (such as the cylindrical housing extension structure shown in  FIGS. 1 and 2 ). Where fitting  203  is configured for insertion within an extension structure, ridge  205  can preferably be configured to interface with the extension structure to allow an appropriate positioning of the extension structure relative to piston  200  as illustrated in  FIG. 1  for example. 
     Referring again to  FIG. 1 , a general methodology in accordance with the invention for the illustrated embodiment can comprise mixing a first component provided within vial  500  with a second component provided within syringe barrel  100 . In an initial state prior to the combining of the two components, each component is isolated from the other. Piston  200  is preferably provided in an initial position relative to the syringe barrel with valve  300  being initially disposed in an “off” position, blocking fluid passageway through the piston. 
     In the initial state, syringe  100  is preferably capped or otherwise sealed (not shown) to prohibit passage of material into or out of syringe barrel  100  through the second end of the syringe. Piston  200  is initially disposed in an inserted position through the first end of syringe barrel  100  and positioned to allow containment of the second component within the syringe barrel. Stopper  208  (illustrated in  FIG. 2 ) preferably prohibits passage of the component from within the syringe barrel between the internal surfaces of the housing and the stopper. 
     While valve  300  is in the off position, vial  500  is positioned by partial insertion within extension housing  600 . It is to be noted that such insertion can, in alternate aspects, be performed by an end user of the mixing assembly or can be performed prior to packaging of the assembly (discussed below). Regardless, the vial cap/septum is initially provided to be intact and preferably to be spaced from puncture device  400  such that the tip of the puncture device is not in physical contact with any portion of vial  500  as initially provided. 
     Once combination and mixing of the separate components is desired, vial  500  can be repositioned by, for example, sliding vial  500  farther within extension  600  to allow device  400  to puncture and be partially inserted through the septum or alternate barrier portion of the vial. 
     Once puncturing has occurred, valve  300  can be rotated or otherwise repositioned into an open position allowing fluid passage through the piston. Such repositioning establishes fluid communication between the interior of vial  500  and the interior of syringe barrel  100  without exposing either of the two components to an environment external to the mixing assembly. One or both of the first component and second component can preferably be in liquid form. Typically, at least the component within the syringe barrel will be in liquid form. Often, the component within vial  500  will be in a dry, powdered or lyophilized form, but may alternatively be in the form of a liquid, solution, suspension or other mixture. 
     Where vial  500  contains a non-fluid component, a liquid component contained within syringe  100  can be introduced into vial  500  and can be combined with the component within vial  500  by, for example, sliding piston  200  from an initial position to a second position such that stopper  208  is repositioned to be nearer the second end of syringe body  100 . Such sliding motion allows fluid to flow from within the syringe chamber through piston  200  and into vial  500  via valve  300 . During the passage the fluid additionally passes through puncturing device  400 . 
     Mixing of the combined components can be performed by, for example, a forward and reverse sliding motion of piston  200  relative to the syringe barrel in a “pumping” type motion. The pumping motion is conducted with the valve  300  in the open position allowing fluid communication between the syringe barrel and vial  500 , typically with the vial being in an inverted position. Alternatively, mixing can be conducted by shaking or agitation of vial  500  and/or the entire mixing assembly, or by a combination of pumping action and shaking, agitating, etc. Once the components have been mixed, the assembly can be prepared for transfer of the mixed agent or, where the mixture is an administration-ready agent the device can be prepared for administrating the agent to an individual. Alternatively, if additional components are to be combined with the mixture, such can be introduced by, for example, flowing into the syringe via the second end, and mixing as described above. 
     In order to prepare for transfer and/or administration of the agent, the mixture can be drawn into syringe body  100  by, for example, sliding piston  200  in a rearward motion, typically with the vial in an inverted position. In other words, piston  200  is partially extracted moving stopper  208  toward the first end of the syringe housing. Upon drawing of all or an appropriate measured amount of the mixture into the syringe barrel, valve  300  can be rotated or otherwise repositioned into the closed position blocking fluid passageway from the syringe barrel through the piston. The syringe barrel can then be uncapped by, for example, removal of a cap such as Luer-lok cap fitting. It is to be understood that the invention also contemplates performing the mixing/preparation of the medicant with a needle fitted to the Luer-lok fitting during the preparation stage. However, the needle is preferably capped and sealed during such operation or otherwise prevented from allowing passage or exposure of material from the syringe barrel to an environment external to the assembly. 
     Where a cap is removed in preparation for transfer or administration of the agent, an appropriate transfer device such as a needle, cannula, transfer tube and/or other appropriate fitting can be attached to the Luer-lok connection and transfer/administration can occur by sliding forward of the piston within the barrel, thereby expelling the contents of the barrel through the needle or alternate transfer structure at the Luer-lok end of the syringe. Such transfer is performed with valve  300  remaining in the closed position throughout. Alternatively, transfer can be accomplished by providing assembly  10  into an appropriate syringe pump, as will be understood by those skilled in the art. 
     Referring next to  FIG. 11 , such shows alternate aspects of the invention having variation relative to the mixing assembly shown in  FIGS. 1-10 . Components that vary relative to those illustrated in earlier figures are either given numeric identifiers having a appendant “a” or a unique identifier relative to those used previously. In the embodiment shown in  FIG. 11 , piston portion  200   a  is shown as having lateral rib structures  220   a  extending lengthwise along stem portion  201   a . Such rib features can be similar or identical to those present on conventional syringe plunger devices. The presence of ribs  220   a  can provide additional support and thereby strengthen the piston. As illustrated, ring structures  212   a ,  216   a  are present at various positions along the length of the stem portion. It is to be understood that the invention contemplates alternate placement and/or alternate numbers of both ring structures and ribs relative to the exemplary configuration depicted in  FIG. 11 . 
     As shown in  FIG. 11 , one or more of rib structures  220   a  can be provided to be gapped in the region of valve receiving opening  214   a . The width of the gap can be configured to allow sufficient space for insertion of the valve and to allow positioning of the head portion of the valve within the gap. It is noted that the extension tabs present on the head of the valve can be specifically configured to come into contact with a rib upon rotation of the valve head. Such can advantageously allow proper open/closed positioning of the valve and alignment of the fluid passageway through the valve and piston stem  201   a.    
     Mixing assembly  10   a  as shown in  FIG. 11  utilizes an extension portion  600  having a groove  602  extending partially along the length of the extension housing. Extension portion  600  can comprise two grooves as illustrated or can comprise fewer or greater number of grooves. Such grooves can allow a slight expansion in the interior circumference of the extension housing. This feature can allow a tight yet reversible fit to be established between extension housing  600  and vial  500 . For example, where the internal area  604  of the extension has a circumference which is slightly less than or equal to the maximum circumference of vial  500 , grooves  602  can allow a slight expansion of the housing to allow insertion of vial  500 . Such configuration can additionally allow retention of vial  500  within internal region  604  until force is applied to extract the vial. 
     The length of the groove(s)  602  can be configured to allow positioning and stabilization of vial  500  within the housing in a position which disposes a septum or cap of vial  500  in a spaced relationship relative to puncture device  400  (discussed below). The spaced relationship can allow packaging and/or shipping of an assembly as a linearly assembled device where the cap of vial  500  remains intact prior to removal of some or all of packaging materials and/or intentional engagement. Accordingly, the length of grooves  602  and the relative length of the grooves and the overall length of housing  600  can vary with appropriate lengths and length ratios depending upon the relative length and positioning of device  400  within such housing and the relative size of vial  500 . 
     An additional alternative aspect of the invention is described with reference to  FIGS. 12-13 . Referring initially to  FIG. 12 , such shows variation of the components of mixing assembly  10   b  relative to the mixing assemblies described in previous figures. Components that vary relative to those illustrated in earlier figures are given either a numeric identifier having an appendant “b”, or a unique identifier relative to those previously used. In the embodiment depicted in  FIG. 12 , piston portion  200   b  is shown as having an alternative fitting  203   b  configuration. Such configuration can allow a portion of extension housing  600   b  to be received within an internal area of fitting  203   b . As illustrated by the exploded view, puncturing device  400  can be seated within piston  200   b  in a manner similar to that described above with respect to earlier embodiments. Additionally the various rings and fins depicted in  FIG. 12  in association with piston  200   b  can be as illustrated or can have any of the alternative configurations described above. 
     Valve  300   b  as depicted in  FIG. 12  can comprise one or more alignment markers  312  preferably on an upper surface of valve head  304  to allow visible and/or tactile alignment of the valve upon insertion within opening  214   b  of piston  200   b . Although depicted as molded arrows, it is to be understood that the invention contemplates alternative alignment markers. 
     The extension  600   b  shown in  FIG. 12  illustrates aspects of the invention where the extension housing has a non-uniform outer circumference. As shown, extension housing  600   b  can comprise a first portion  605   b  having a smaller circumference than a second portion  606   b . Such configuration can allow insertion and seating of portion  605   b  within the piston fitting configuration  203   b  as illustrated. 
     The features of extension  600   b  are described and more fully illustrated with reference to  FIGS. 13A and 13B . As shown in  FIG. 13A , extension housing  600   b  has an internal area  604   b  configured to receive a vial such as a standard vial or an alternative container as described above. One or more slots  602   b  can extend longitudinally from the receiving end of the extension housing to allow slight expansion of the housing. In some instances, the receiving/opening end of housing  600   b  can have an internal diameter equal to or slightly smaller than the diameter of a vial prior to insertion of the vial. Insertion of the vial can expand the housing due to the presence of slots  602   b . Such configuration can allow a snug fit and stabilization of the inserted vial. In combination with particular packaging aspects (discussed below) slots  602   b  can additionally allow stabilization of vial positioning during storage and/or shipping. 
     Referring to  FIG. 13B , at least a portion of a length of the interior area can comprise interior ribs  607   b . Preferably, at least an interior length associated with segment  605   b  contains ribs  607   b  which can assist in positioning and retaining vial  500  (shown in  FIG. 12 ) within the extension housing. Such ribs can additionally provide support for the vial within the housing upon puncturing of a septum or alternative barrier material. 
     Although  FIGS. 13A-13B  depict extension  600   b  as having ribs  607   b  along only a portion of interior sidewalls of opening  604   b , it is to be understood that the invention contemplates alternative aspects where ribs are provided along a portion or an entirety of the interior surface of segment  606   b . The interior sidewalls and/or rib portions within housing  600   b  can be contoured to correspond to an outer shape of vial  500  whether the vial is of the conventional shape illustrated or has and alternative vial or container shape. 
     Although housing configurations having segments of non-equivalent circumference are illustrated in  FIG. 12  as being utilized with a single piece piston stem, it is to be understood that the invention contemplates utilization of such housing configuration with any of the alternative piston configurations described herein. 
     In addition to the embodiments described above wherein vial  500  is provided independently of the piston portion of the assembly the invention additionally encompasses configurations where a container is integral with the piston portion as exemplified in  FIG. 14 . The exemplary piston  200   c  has features having numeric identifiers with an appendant “c” to distinguish from earlier embodiments. It is to be noted, however, that the general concepts and variations of the earlier embodiments can apply equally to the embodiment depicted in  FIG. 14 . It is to be additionally noted that in the piston  200   c , stopper portion can be provided as an independent component or can be an integral part of piston  200   c . Accordingly, stopper  208   c  can comprise a material that differs from the piston stem or can be formed of a material identical to the material utilized for forming piston stem  201   c.    
     The alternate aspects of the invention depicted in  FIG. 14  include variation of the extension portion to form a container  650   c  having a base surface  652   c  which opposes first end  204   c  of the piston forming an enclosed compartment. Container  650   c  can be formed to be integral with the piston during a common fabrication event (such as molding), or by affixing an independently formed container structure to the fitting portion  203   c  of the piston. Alternatively, container portion  650   c  can be reversibly attached to the piston. Attachment (whether permanent or reversible) of an independently formed container to second end  204   c  can comprise insertion of fitting portion  203   c  similar to the attachment of extension portion  600  described above. Joining and affixing of the container portion to the piston can comprise for example a snap-on type joint or welding. 
     Alternative integral vial-piston configurations contemplated by the invention include, for example, providing an opening through the vial portion, for example through base surface  652   c  (not shown), which can be utilized during providing of a medicant component into the vial and/or during drying or lyophilization of the component. Such opening can be subsequently capped or otherwise sealed. 
     The material utilized for construction of container  650   c  is not limited to a particular or class of materials. Container  650   c  can in particular instances be formed of a plastic material which can be either a rigid material or a collapsible material. 
     A component of a medicant or other mixture to be formed can be provided within container  650   c  and can be isolated from an associated syringe barrel (not shown) by providing a valve into valve receiving opening  214   c . An appropriate valve can be, for example, any of the valves described above. The component provided in container  650   c  can be provided within the container prior to attachment of the container or alternatively can be provided into the integral or attached container via fluid pathway  206  through the piston and stopper opening  210   c . The associated valve can then be closed to prevent the contained component from flowing outward through the piston. 
     Where container  650   c  is formed independently and is attached to the piston either reversibly or permanently, an o-ring  230   c  can be provided in association with fitting  203   c  to provide a fluid seal between the piston and internal surfaces of container  650   c . Alternatively, other appropriate sealing techniques can be utilized. It is noted that piston  200   c  lacks an associated piercing structure. Accordingly, first end  204   c  of the piston can be modified from earlier discussed configurations to lack accommodation features for the piercing device. Further, the illustrated attachment of container  650   c  to piston  200   c  is an exemplary configuration and alternative shapes and attachment methods are contemplated. 
     Although the integral container/piston structure illustrated is shown to have rings and ribs  220   c  it is to be understood that the ribs and rings are optional as is the number of such ribs and/or rings, as set for above with respect to earlier described aspects. Additionally, piston stem  201   c , which is shown as a single piece, can alternatively comprise multiple segments as described above (and/or the rotational valve type configuration described below). 
     Another alternate piston configuration involving a rotational-valve type piston is exemplified and described with reference to  FIGS. 15A-D . Referring initially to  FIG. 15A , a piston  200   d  is depicted which can be utilized in conjunction with additional mixing assembly components discussed above. Piston  200   d  can comprise a two part piston stem  201   d  which can optionally include ribs  220   d  and/or rings  212   d . Stem  201   d  comprises a first portion  230   d  and a second portion  232   d . The lengths of first segment  230   d  and second segment  232   d  can be identical or can differ. The length of each segment and their relative lengths thereof can be determined by manufacturability and overall length of the piston. Piston  200   d  is shown as having an independently formed stopper  208   d . However, it is to be understood that such stopper can be integral with first portion  230   d  of piston  200   d . An exemplary extension portion  600   d  is illustrated which can be configured for receiving a vial as described above. As illustrated in  FIG. 15 , extension portion  600   d  can be integral with second portion  232   d . Such integral piston/extension configuration can be adapted for use with any of the alternative single part piston stem aspects described. 
     Referring next to  FIG. 15B , such figure shows an exemplary puncturing device  400   d  which can be disposed within an internal region of extension  600   d  and which can be positioned to allow communication between an associated vial and fluid pathway  206   d  which traverses the length of piston stem  201   d . First segment  230   d  and second segment  232   d  can be configured to interact to provide valve action. As illustrated, first segment  230   d  can comprise a frustoconical protrusion  226  having a pair of openings  228  which pass entirely through the frustoconical protrusion. Second portion  232   d  can be configured to have a corresponding frustoconical interior chamber region  227  configured to receive protrusion  226 . Although a frustoconical shape is illustrated, the invention contemplates protrusion shapes and corresponding receiving chamber shapes other than the exemplary frustoconical shape. 
     Fluid passageway  206   d  is shown as extending partially through frustoconical protrusion  226  in a discontinuous manner such that direct longitudinal fluid passage is prevented. Fluid passage  206   d  resumes its longitudinal progress on an opposite side of a solid block of material  223 . One or more grooves  229  can be disposed within an interior sidewall of second segment  232   d  which, when aligned with openings  228  can allow fluid passage from fluid passageway  206   d  of first portion  230   d  into the portion of such fluid passageway passing through second portion  232   d . Alignment of openings  228  with grooves  229  can be achieved by opposing rotation of portion  230   d  relative to portion  232   d . Such valve/piston configuration is further described with reference to  FIG. 15C . As illustrated, protrusion  226  can comprise one or more o-rings  222  to allow fluid seal to be formed upon insertion of the protrusion into receiving chamber  227 . 
     Referring to second segment  232   d  of piston  200   d , a pair of grooves  229  is illustrated as being arc shaped grooves formed in the sidewall material of the piston. It is to be understood that alternative shaped grooves are contemplated and the arc shaped grooves are but one exemplary configuration. Referring next to  FIG. 15D , upon insertion of the protrusion into the receiving chamber of second segment  232   d , rotation of part  230   d  and  232   d  relative to one another can be performed to align fluid access openings  228  with grooves  229  to allow connection of passageway  206  via access openings  228  allowing fluid passageway between segments  230   d  and  232   d . Further rotation or reverse rotation can be utilized to misalign access openings  228  and groove  229  to again close fluid access between the two piston parts. 
     Although fluid access openings  228  are shown as extending entirely through protrusion  226  (see  FIG. 15C ) it is to be understood that such openings can extend less than an entirety of the width of such protrusion. Alternatively, access openings  228  can be provided on a single side of such protrusion. In another alternative, additional access openings can be provided partially or entirely through protrusion  226 . Similarly, a fewer or greater number than the illustrated two connecting grooves can be provided within second segment  232   d.    
     In addition to the features shown and described above, in particular instances one or more filters may be utilized for removal of particulates prior to administration. Appropriate filter(s) may be incorporated within any of the devices above for example within the fluid passageway through the piston. Additionally or alternatively, one or more filters may be provided in association with the syringe outlet, either internally or externally to the syringe barrel. 
     Methodology for mixing components to prepare a mixture utilizing the rotational piston type valve configuration illustrated in FIGS.  15 A-D can be conducted in a manner similar to methodology described with reference to  FIG. 1 . Using the rotational piston type device, rather than rotating or repositioning independent valve component  300  illustrated in  FIG. 1 , first and second segments of the piston would be opposingly rotated to open or close fluid passageway through the piston at the appropriate stage of the mixing procedure. 
     Another alternate embodiment of a mixing device in accordance with the invention is described with reference to  FIGS. 16A-B . Referring to  FIG. 16A , a mixing system  10   e  can comprise a syringe  100  and an adapter  700  which can be reversibly attachable to the syringe  100  by, for example, providing a female Luer-lok or alternative fitting  708  on a first end of adapter  700 . Syringe  100  can preferably be a conventional syringe utilizing a conventional type piston/plunger  200   e . Adapter  700  can be provided to have a first fluid passageway  706  (denoted with dashed lines) which passes through female Luer-lok fitting  708  and through a segment of adaptor housing  704  to a valve  800 , and a second fluid passageway segment  707  (denoted with dashed lines) which passes from the valve  800  to an interior area  703  of a vial housing  702 . Although depicted as inline passageways, the invention contemplates passageways  706  and  707  being angled or orthogonal relative to one another. 
     As illustrated in  FIG. 16B , internal chamber  703  can be configured to receive a vial  500  such as, for example, a standard vial. Alternative vials or container types can be utilized as described above. Vial housing  702  can additionally be configured to contain an associated puncture device  400   e  which can be similar to or identical to the puncture devices described above. Insertion of vial  500  into housing  702  can be as described above with respect to extension housing  600  with reference to  FIGS. 1-10 . 
     Adapter  700  can be formed of any appropriate material and in particular instances will comprise a plastic material such as any of the plastic materials discussed above with respect to syringe housings and pistons. Valve  800  can be any of the valve types discussed above with respect to exemplary valve  300  and can accordingly comprise any of the materials described with reference to such exemplary valve. Alternatively, adapter  700  can be configured to have a rotating type valve system as discussed with reference to  FIGS. 15A-D . 
     Methodology for mixing independent components to prepare a mixture or administration-ready agent utilizing the assembly illustrated in  FIGS. 16A-B  can comprise providing a first component in an independent vial  500  and providing a second component to be combined and mixed with the first component within syringe  100 . Syringe  100  and vial  500  are then each attached to adapter  700 . Attachment and puncturing of vial  500  can be performed as described above with respect to earlier embodiments having puncture device  400 . The order of attachment of vial  500  and syringe  100  is not limited to a particular sequence. Preferably, valve  800  is in a closed position during attachments of the vial and the syringe. 
     Upon assembly, valve  800  can be rotated or otherwise repositioned into an open position to establish fluid communication between first pathway segment  702  and second pathway segment  707  allowing fluid passage through the adaptor. Accordingly, fluid communication is established between vial  500  and syringe  100 . 
     Combining of the first and second components can comprise drawing first component from vial  500  into the syringe (typically with the vial in an inverted position), or can comprise expelling the second component from the syringe into vial  500 . Mixture of the components can comprise a pumping action as described above with earlier embodiments independently or in combination with shaking or otherwise agitating the combined components. The resulting mixture can be drawn internally within syringe housing  102   e  typically while the vial is inverted, and valve  800  can be closed. Where the mixture is to be subsequently transferred or administered to an individual, adapter  700  can be removed from attachment to Luer-lok fitting  108   e  and a transfer device such as a needle, cannula, transfer tube or other transfer structure can be attached to Luer-lok device  108   e . Transfer or administration of the mixture can then be achieved by expelling the mixture from the internal chamber within syringe housing  102   e.    
     An alternative configuration of an adaptor comprised by an assembly is illustrated in  FIG. 17 . Assembly  10   e ′ comprises an alternative adaptor configuration  700   e ′ relative to that depicted in  FIGS. 16A and 16B . The illustrated adaptor is a “three-way” adaptor having a first segment  710   e ′ which extends from a three-way valve  800   e ′ to a first port  711   e ′ having a fitting (for example a Luer-lok type fitting) for connection with syringe  100   e ′. Adaptor  700   e ′ additionally includes a second segment  712   e ′ which extends from the position of valve  800   e ′ to a second port  713   e ′. The adaptor additionally has a third segment  714   e ′ extending from position of valve  800   e ′ to a third port  715   e ′ which can comprise a fitting configured for insertion or other association with housing extension  600   e ′ as illustrated. Port  715   e ′ can additionally be configured to include a piercing structure (not shown) such as the various piercing devices described above. Extension portion  600   e ′ can have any of the configurations described above for receiving, stabilizing and/or retaining vial  500  which is shown in a partially inserted position within extension  600   e ′. Syringe  100   e ′ can be a standard conventional syringe with an associated standard type piston  200   e ′ as illustrated, or can be an alternative syringe configuration, including but not limited to, those described above. 
     The triple-port adaptor configuration illustrated in  FIG. 17  can advantageously allow introduction and/or removal of material to or from the system without dissociation of the syringe and/or vial  500 . For example, after mixing or preparing a medicant utilizing methodology analogous to that described above, the prepared medicant can be transferred or otherwise removed from assembly device  10   e ′ through port  713   e ′. Such transfer or removal can be accomplished by, for example, attaching an appropriate vial, transfer tubing or other transfer apparatus to port  713   e ′. As illustrated, port  713   e ′ has a general type fitting. However, a Luer-lok or other alternative fitting can be utilized as appropriate for attachment to a desired container or transfer apparatus. 
     Transfer of material from the assembly via port  713   e ′ can be useful for applications such as IV administration. Alternative administration such as intramuscular injection, can utilize syringe  100   e ′ independently after removal from the assembly. In either instance, piston depression during injection can be performed manually or utilizing a syringe pump. 
     Where a material such as a liquid material for example, is to be introduced into assembly  10   e ′ such introduction can be accomplished by passage through port  713   e ′ and adaptor segment  712   e ′. The fluid introduced can be directed into vial  500  or into syringe  100   e ′ as appropriate, by manipulation and positioning of valve  800   e ′. Introduction of a fluid into the assembly may be appropriate for example where each of first and second components (within the vial and syringe respectively) is provided in a dry or concentrated form. 
     The configuration of adaptor  700   e ′ illustrated in  FIG. 17  can allow linear alignment of syringe housing  102   e ′ and vial  500 . It is to be understood that the invention additionally contemplates configurations having the positions of segments  714   e ′ and  712   e ′ exchanged such that vial  500  and syringe body  102   e ′ are positioned in an orthogonal arrangement. Further, adaptor  700   e ′ can be alternatively configured to provide segments  710   e ′,  712   e ′ and  714   e ′ at alternative angles relative to one another as compared to the orthogonal arrangement shown. Adaptor  700   e ′ can optionally have additional segments and ports and can comprise a higher-order valve relative to the three-way valve depicted. 
     An additional alternative device configuration in accordance with the invention is described with reference to  FIGS. 18A-18C . Referring to  FIG. 18A , assembly  10   f  includes a piston  200   f  having a rotational type valve portion disposed at second end  204   f . Valve portion  226   f  is functionally and structurally analogous to valve portion  226  as shown in  FIG. 15B  and as described above. However, rather than being disposed at a junction between two portions of a piston stem as illustrated in  FIG. 15B , valve portion  226   f  is disposed at the end of the piston and is insertable within an opening  557  of a vial cap  550  in accordance with the invention. Vial cap  550  can be configured for utilization in conjunction with a vial such as the exemplary vial  500   f  depicted in  FIG. 18A . Vial  500   f  can be, for example, a standard medicant vial or alternative container. Vial cap  550  can comprise a base portion  552  and a raised cylindrical or alternatively shaped portion  554  having an opening  557  configured for receiving valve portion  226   f  of the piston structure. 
     Upon insertion of valve portion  226   f  of the piston into receiving opening  557  of cap  550 , the lid/piston combination can function as a rotational valve as described above with respect to the rotational valve depicted in  FIG. 15 . 
     Referring next to  FIG. 18B , grooves  559  provided within interior sidewalls of opening  557  can be aligned with fluid passageways  228   f  of valve portion  226   f . Alignment can provide fluid passageway between passageway  206   f  through piston  200   f  and a corresponding fluid passage  560  which passes from opening  557  through base portion  552  of cap  550 , thereby allowing fluid passage between a syringe barrel associated with piston  200   f  and a vial or container associated with cap  552 . Fluid alignment and the resulting contiguous passageway is depicted in  FIG. 18C . Selective fluid communication can be discontinued by opposing-rotation of piston  200   f  relative to vial cap  550 . In the configuration depicted in  FIG. 18  A-C, fluid access is provided directly between piston  200   f  and a vial such that cap  550  can be utilized in an absence of any piercing structure such as the exemplary piercing structure described above. 
     The invention also contemplates utilization of features of the device shown in  FIG. 18  in combination with one or more features described in alternate embodiments above. In particular applications it can be preferable to provide multiple fluid barriers between a syringe barrel and a vial. Accordingly, the rotational valve configuration depicted in  FIG. 18  can be utilized in combination with a second rotational valve such as depicted in  FIG. 15  or an alternative valve such as described above with reference to earlier figures. Such multiple valve configurations can advantageously provide an additional safeguard against inadvertent contact or mixing of separate components housed within a syringe barrel and the medicant vial. Filters, such as those described above, can additionally be utilized with the device of  FIG. 18  and variants thereof. 
     Methodology for utilization of the assembly configuration depicted in  FIGS. 18A-C  is analogous to the methodology described above (in an absence of performing steps for piercing a vial cap). Where multiple valves are provided, fluid communication can be established between the syringe barrel and the medicant vial by placing each of the valves in the open position. Mixing can be achieved by, for example, agitation and/or utilization of a piston pumping action. One or both valves can be utilized to discontinue fluid passage, allowing transfer and/or administration of the prepared medicant. 
     Although various devices of the invention are described as utilizing a single vial  500 , it is to be understood that the invention encompasses aspects where multiple vials are utilized. In such instances, a first vial can be removed from the assembly after withdrawing all or a desired portion of the original vial content, and can be replaced by a second vial comprising additional or differing material. Accordingly, the mixing systems of the invention can be utilized for preparing medicants which are made up of three or more components. Mixing of the additional component can be achieved in a manner analogous to the mixing methodology discussed above for a corresponding assembly configuration. 
     Mixing/administration assemblies in accordance with the invention can be shipped as a singular unit including a linear arrangement of the syringe device and vial. Where an assembly utilizes an independent vial the vial can be provided in or out of alignment with respect to the mixing/administration device. Alternatively, where a vial is independent, such can be packaged separately from the mixing device. Exemplary packaging in accordance with the invention which can be utilized for a linearly aligned vial and mixing device combination is described with reference to  FIGS. 19 and 20 . 
     As illustrated in  FIG. 19  a medicant preparation system  20  in accordance with the invention can comprise a packaging component  900  configured to receive assembly  10  in linear alignment with a vial  500 . Packaging component  900  can be a tray type component as illustrated having a multipart cavity  901 ,  902 ,  903 . Cavity portion  901  can be configured to approximate the shape of syringe  100  and associated cap  50 . Cavity portion  902  can be shaped to approximate the shape of piston portion  200 . Cavity portion  903  can be shaped to correspond to the shape of the combined extension portion (including the fitting to piston  200  in the illustrated embodiment) and an associated vial  500  which can be partially inserted within housing  600 . 
     In most circumstances it can be preferable that vial  500  be only partially inserted with housing  600 . In particular instances it can be highly preferred to avoid contact between the piercing structure comprised by the assembly and the cap or septum comprised by vial  500 . Accordingly, a projection  904  can be provided within cavity portion  903  which can be insertable within groove  602  of extension housing  600 . Projection  904  can be positioned within the groove to stabilize a spaced relationship between vial  500  and the puncturing device to avoid contact with the piercing structure prior to removal of the assembly from the packaging cavity. 
     Cavity  901 ,  902 ,  903  can be configured to be shaped closely to the shape of the assembly to provide stability to the assembly, preferably stabilizing the position of the piston relative to the syringe barrel. Although the cavities depicted in  FIG. 19  mirror the overall shape of the assembly, it is to be understood that the cavity can be alternatively shaped for providing position placement and stability. 
     Packaging component  900  can be formed by, for example, molding. Appropriate materials for packaging component  900  include plastic materials, preferably plastics which have suitable strength for providing positioning and stability of the packaged assembly. 
     A cover  905  can optionally be provided which can be associated with packaging component  900 . Cover  905  can be provided to cover at least the upper portion/opening of the tray to protect the assembly within the packaging. In particular instances, cover  900  can be utilized to seal the packaging and can allow a sterile environment to be created and maintained within the packaging. The cover can comprise a translucent or opaque material. It can be preferable that at least a portion of the cover be transparent to allow visual inspection of the contents (device and/or labels). 
     As depicted, cover  905  is a sheet of material which may be affixed to component  900 . Alternatively, the cover can be a lid type cover which can be configured either to fit insertably within the tray opening or to have at least an upper portion of the tray fit insertably into a lid cavity (not shown). 
     As illustrated in  FIG. 19 , one or more labels  910 ,  912  can be provided in association with assembly  10 . A first label  910  can be utilized in association with the syringe portion of the device and can provide information regarding the contents of the syringe. A second label  912  can be provided associated with vial  500  and can be utilized to identify or provide information regarding the component within the vial. Where the medicant is being provided to a particular individual, one or more of the labels  910  and  912  can contain indicia of the patient. Although  FIG. 19  depicts two labels an alternative number of labels can be provided. The content of the information provided in the label is also not limited to any particular content and can provide additional information such as, for example, instructions, warnings, etc. Additionally or alternatively, labeling may be provided in association with packaging component  900  and/or  905  (not shown). 
     The type of label(s) utilized in association with mixing device  10  and/or associated via  500  is not limited to a particular label type. Exemplary labels can include bar codes as illustrated. Alternatively or additionally, one or both of labels  910  and  912  can be a radio frequency identification (RFID) label (not shown). Appropriate bar code and/or RFID labeling can be particularly useful for identifying and tracking lots, for record keeping purposes regarding the medicants and/or patient specific information. Such labeling can provide an additional safety measure. For example, in the event of an adverse reaction upon administering the prepared medicant, information provided on the label can be utilized to identify source, lot number, etc., which can in turn be utilized to track other assembly devices or device component containing material from the identified lot. Such labeling can additionally be utilized to identify others who may be at risk and/or provide information regarding the particular reaction, etc. 
     In the event of adverse reaction or identification of defect, analysis of any material retained within the device after administration can be analyzed by, for example, analysis techniques including but not limited to mass spectrometry and/or gas-liquid chromatography. Appropriate reporting to the FDA can then be performed. 
     Referring to  FIG. 20  such shows an additional packaging aspect of the invention. Assembly device  10  can be provided within a second packaging component  920  which can be a sealed pouch type component as illustrated. Packaging component  920  can preferably provide an enclosed environment around device  10  which protects the device and components from exposure to an environment external to packaging component  920 . In particular instances, it can be preferable that the internal environment be sterile, especially where medicant components and/or components of system  10  are sterile and are to be maintained in sterile condition prior to administration. 
     Packaging component  920  can preferably be translucent and can be formed from an appropriate translucent plastic material. The particular material utilized can preferably be selected to provide flexibility to allow manipulation of assembly  10  without opening of packaging component  920 . In particular, it can be preferable that component  920  be provided to have sufficient internal volume and material flexibility to allow the vial to be manipulated for engagement and puncturing of the cap/septum. Component  920  can preferably also be retained in the sealed condition while manipulating the valve and piston during combining and mixing of the medicant components (described above). The ability to prepare the medicant for administration without opening of packaging component  920  can minimize or prevent contamination by avoiding exposure to an environment external to the packaging component. Upon preparation of an administration ready medicant, package component  920  can be opened, the protective cap over the forward end of the syringe can be removed, and transfer and/or administration can be performed utilizing methods described above. 
     Although each can be utilized independently, packaging components  920  and  900  depicted in  FIGS. 20 and 19  respectively, are configured to allow utilization of both components for a given device. For example, a mixing device can be enclosed within packaging component  920  and component  920  and its enclosed device can be inserted into the cavity of component  900 . Accordingly, component  900  can be utilized to provide positioning and stabilization during shipping and storing. The mixing system can be removed from packaging component  900  while being retained within component  920 . The pouch component  920  can be retained in a sealed condition during combination and mixing of the independent components to prepare an administration ready medicant. Where each of components  920  and  900  are utilized, cover  905  can optionally be provided. 
     Although  FIGS. 19 and 20  depict a particular mixing system configuration, it is to be understood that similar packaging concepts can be utilized and adapted for any of the alternative mixing systems described herein. 
     Each of  FIGS. 19 and 20  depict labels associated only to device components. Additional labels (not shown) may be associated with the packaging either by including within the packaging or by affixing externally to the packaging component(s). The additional labeling can be, for example, any of the label types discussed above or alternative labels known to those skilled in the art. 
     An additional packaging aspect in accordance with the invention is illustrated in  FIG. 21 . Assembly  10  as illustrated corresponds to the configuration illustrated in  FIG. 17  and described with reference thereto. Packaging component  920  corresponds to packaging component  920  discussed above with reference to  FIG. 20 . As  FIG. 21  illustrates, component  920  can be configured to provide access to assembly  10  by a tear strip  921  or alternatively sealed opening. The illustrated packaging configuration can allow mixing and preparation of a medicant in a sealed environment followed by opening of the package along tear strip  921 . Where appropriate, the prepared medicant can be transferred from assembly  10  by, for example, attaching an appropriate transfer apparatus to the available port (port  713  as described and illustrated in  FIG. 17 ). Such attachment and transfer can be conducted while all or a portion of assembly  10  remains within the package enclosure. 
     Where preparation of a medicant involves addition of material into assembly  10  (described above), such material can be added by, for example, opening of tear strip  921  and connection of an appropriate transfer device to the available (non-occupied) port and positioning of the valve to allow introduction of the material into the syringe or vial as appropriate. Additional mixing and preparation steps can be performed as described above with or without removal of assembly  10  from packaging  920 . Transfer or administration of a prepared medicant from the assembly can comprise placement of the entire assembly into a syringe pump, can comprise removal of the vial and/or the adaptor from the assembly prior to placement of the syringe into a syringe pump, or can comprise manual manipulation of the syringe piston. 
     An alternative tray-type packaging component  900   a  is illustrated in  FIG. 22 . As illustrated, a single cavity  913  can be provided having raised portions  914 ,  915 ,  916  and  917 . Raised portions  914 - 917  can be platform-type structures having appropriate shape and positioning to stabilize an inserted mixing assembly. Alternative numbers and positioning of raised portions is contemplated relative to the particular configuration shown in  FIG. 22 . Packaging  900   a  can additionally include a raised protrusion (not shown) similar in form and function to protrusion  904  depicted in  FIG. 19  and described above. Such protrusion can be configured to insert into a slot present in the extension housing as described above to retain vial  500  in a non-engaged position relative to the piercing structure. Although packaging component  900   a  is depicted as being configured for the device illustrated in  FIG. 17 , such can be adapted for any of the alternative embodiments described above. Additionally, packaging component  920  such as illustrated in  FIG. 21  can be utilized simultaneously with component  900   a  by, for example, providing an assembly within packaging component  920  prior to insertion of the assembly into the tray-type component of the packaging. 
     Packaging component  900   a  can comprise a lid portion  905   a  analogous to that shown and described with reference to  FIG. 19 . Appropriate labeling of assembly components (i.e. vial and/or syringe) can be utilized independently or in addition to labeling of one or more of the packaging components as described previously. 
     Where an additional material is to be added into the exemplary assembly depicted in  FIG. 22 , lid  905   a , or a portion thereof, can be removed from packaging component  900   a  followed by opening of a tear strip  921  such as that depicted in  FIG. 21 . An appropriate transfer device can be connected to the non-occupied port prior to extracting the assembly from the package tray. The introduction of material can be achieved by manipulation of the valve and piston without further removal of the assembly from packaging component  920 . Such accessibility to the valve and port can allow introduction of additional materials into the assembly while limiting exposure of the assembly and components therein to an external environment. 
     In compliance with the statute, the invention has been described in language more or less specific as to structural and methodical features. It is to be understood, however, that the invention is not limited to the specific features shown and described, since the means herein disclosed comprise preferred forms of putting the invention into effect. The invention is, therefore, claimed in any of its forms or modifications within the proper scope of the appended claims appropriately interpreted in accordance with the doctrine of equivalents.