Patent Publication Number: US-11045392-B2

Title: System with adapter for closed transfer of fluids

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application is a continuation of U.S. patent application Ser. No. 14/691,898, filed Apr. 21, 2015, which claims priority to U.S. Provisional Application Ser. No. 61/982,039, filed Apr. 21, 2014, each of which are hereby incorporated by reference in their entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Disclosure 
     The present disclosure relates generally to a system for the closed transfer of fluids. More particularly, the present disclosure relates to a system that accommodates vials having different sizes and provides leak-proof sealing and pressure equalization during engagement of a cannula with a vial, during transfer of a substance from a vial chamber to a barrel chamber via the cannula, and during disengagement of the cannula from the vial. 
     2. Description of the Related Art 
     Health care providers reconstituting, transporting, and administering hazardous drugs, such as cancer treatments, can put themselves at risk of exposure to these medications and present a major hazard in the health care environment. For example, nurses treating cancer patients risk being exposed to chemotherapy drugs and their toxic effects. Unintentional chemotherapy exposure can affect the nervous system, impair the reproductive system, and bring an increased risk of developing blood cancers in the future. In order to reduce the risk of health care providers being exposed to toxic drugs, the closed transfer of these drugs becomes important. 
     Some drugs must be dissolved or diluted before they are administered, which involves transferring a solvent from one container to a sealed vial containing the drug in powder or liquid form, by means of a needle. Drugs may be inadvertently released into the atmosphere in gas form or by way of aerosolization, during the withdrawal of the needle from the vial, and while the needle is inside the vial if any differential pressure exists between the interior of the vial and the surrounding atmosphere. 
     SUMMARY OF THE INVENTION 
     In one aspect of the present invention, a vial access device includes an outer housing defining an annular space and an inner space, an inner housing having a body defining a central opening with at least a portion of the inner housing positioned within the inner space of the outer housing, and a connector configured to engage a mating connector with the connector having a body defining a central passageway and a flange that extends radially outward from the body. The flange and the housing define a filter space that is in fluid communication with the annular space. A pressure equalization system is positioned within the annular space of the outer housing with the pressure equalization system configured to change a volume of space defined by the annular space and the pressure equalization system. The device also includes a vial connection element configured to be secured to a vial with the vial connection element having a body and a spike member extending from the body. The spike member defines a fluid passageway and a vent passageway with the fluid passageway in fluid communication with the central passageway of the connector and the vent passageway in fluid communication with the filter space and the annular space. A filter is positioned in the filter space. 
     The vial access device may further include a top cap having a body secured to the inner housing with the body of the top cap defining a recessed portion that receives a portion of the connector. The top cap may include a gripping surface configured to allow a user to remove the top cap from the inner housing. 
     The body of the vial connection element may define a central passageway, with the body of the vial connection element received within the central passageway of the connector with the central passageway of the vial connection element aligned with the central passageway of the connector. An O-ring may be positioned between the vial connection element and the connector. 
     The flange of the connector may abut a ledge defined by the outer housing, with the ledge extending radially inward into the inner space of the outer housing. 
     The inner housing may have a top surface having a shape that conforms to an outer surface of the outer housing. The body of the inner housing may have a cylindrical portion extending axially into the inner space of the outer housing. A membrane may be positioned on the connector adjacent to the central passageway of the connector. 
     The pressure equalization system may include a toroidal balloon configured to expand axially outer of the annular space of the outer housing. The filter may be annular and may be a hydrophobic filter. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the disclosure itself will be better understood by reference to the following descriptions of aspects of the disclosure taken in conjunction with the accompanying drawings, wherein: 
         FIG. 1  is an exploded, perspective view of a system in accordance with an aspect of the present invention. 
         FIG. 2  is an assembled, perspective view of a system in accordance with an aspect of the present invention. 
         FIG. 3  is a bottom, assembled view of a system in accordance with an aspect of the present invention. 
         FIG. 4A  is a top, assembled view of a system in accordance with an aspect of the present invention. 
         FIG. 4B  is a cross-sectional view of the system taken along line  4 B- 4 B of  FIG. 4A  in accordance with an aspect of the present invention. 
         FIG. 4C  is a cross-sectional view of the system taken along line  4 C- 4 C of  FIG. 4A  in accordance with an aspect of the present invention. 
         FIG. 4D  is a perspective view of an adapter within an elongate aperture of an outer housing of a system in accordance with an aspect of the present invention. 
         FIG. 5A  is a perspective view of an outer housing in accordance with an aspect of the present invention. 
         FIG. 5B  is a cross-sectional view of the outer housing of  FIG. 5A  in accordance with an aspect of the present invention. 
         FIG. 6A  is a perspective view of an inner housing in accordance with an aspect of the present invention. 
         FIG. 6B  is a side elevation view of an inner housing in accordance with an aspect of the present invention. 
         FIG. 6C  is a cross-sectional view of the inner housing of  FIG. 6A  in accordance with an aspect of the present invention. 
         FIG. 6D  is a top view of an inner housing in accordance with an aspect of the present invention. 
         FIG. 7  is a cross-sectional view of a system in accordance with an aspect of the present invention. 
         FIG. 8A  is a perspective view of a connector in accordance with an aspect of the present invention. 
         FIG. 8B  is a side elevation view of a connector in accordance with an aspect of the present invention. 
         FIG. 8C  is another perspective view of a connector in accordance with an aspect of the present invention. 
         FIG. 8D  is another side elevation view of a connector in accordance with an aspect of the present invention. 
         FIG. 8E  is a partial-sectional view of the connector of  FIG. 8A  in accordance with an aspect of the present invention. 
         FIG. 8F  is a bottom view of a connector in accordance with an aspect of the present invention. 
         FIG. 8G  is a top view of a connector in accordance with an aspect of the present invention. 
         FIG. 9A  is a side elevation view of a connector in accordance with another aspect of the present invention. 
         FIG. 9B  is a perspective view of a connector in accordance with another aspect of the present invention. 
         FIG. 10  is a perspective view of a top cap housing in accordance with an aspect of the present invention. 
         FIG. 11  is a cross-sectional view of a system in accordance with an aspect of the present invention. 
         FIG. 12A  is a perspective view of an adapter in accordance with an aspect of the present invention. 
         FIG. 12B  is another perspective view of an adapter in accordance with an aspect of the present invention. 
         FIG. 12C  is a top view of an adapter in accordance with an aspect of the present invention. 
         FIG. 12D  is a side elevation view of an adapter in accordance with an aspect of the present invention. 
         FIG. 12E  is a bottom view of an adapter in accordance with an aspect of the present invention. 
         FIG. 12F  is another side elevation view of an adapter in accordance with an aspect of the present invention. 
         FIG. 12G  is another side elevation view of an adapter in accordance with an aspect of the present invention. 
         FIG. 12H  is another side elevation view of an adapter in accordance with an aspect of the present invention. 
         FIG. 13  is a perspective view of a system of the present disclosure connected to a first vial in accordance with an aspect of the present invention. 
         FIG. 14  is a side elevation view of a system of the present disclosure connected to a first vial in accordance with an aspect of the present invention. 
         FIG. 15  is a cross-sectional view of the system connected to a first vial taken along line  15 - 15  of  FIG. 14  in accordance with an aspect of the present invention. 
         FIG. 16  is a perspective view of a system of the present disclosure connected to a second vial in accordance with an aspect of the present invention. 
         FIG. 17  is a side elevation view of a system of the present disclosure connected to a second vial in accordance with an aspect of the present invention. 
         FIG. 18  is a cross-sectional view of the system connected to a second vial taken along line  18 - 18  of  FIG. 17  in accordance with an aspect of the present invention. 
         FIG. 19  is a side elevation view of a system having a pressure equalization system connected to a vial in accordance with an aspect of the present invention. 
         FIG. 20  is an exploded, perspective view of a system in accordance with an aspect of the present invention. 
         FIG. 21  is an assembled, perspective view of a system in accordance with an aspect of the present invention. 
         FIG. 22  is a perspective view of a barrel assembly in accordance with an aspect of the present invention. 
         FIG. 23  is a cross-sectional view of the barrel assembly of  FIG. 22  in accordance with an aspect of the present invention. 
         FIG. 24  is a perspective view of a system in accordance with a further aspect of the present invention. 
         FIG. 25  is an exploded perspective view of the system of  FIG. 24  in accordance with an aspect of the present invention. 
         FIG. 26  is a front view of the system of  FIG. 24  in accordance with an aspect of the present invention. 
         FIG. 27  is a cross-sectional view taken along line  27 - 27  in  FIG. 26  in accordance with an aspect of the present invention. 
         FIG. 28  is a perspective view of the system of  FIG. 24  provided with a packaging member in accordance with an aspect of the present invention. 
         FIG. 29  is an exploded perspective view of the system of  FIG. 24  provided with a packaging member in accordance with an aspect of the present invention. 
         FIG. 30  is a front view of the system of  FIG. 24  provided with a packaging member in accordance with an aspect of the present invention. 
         FIG. 31  is a cross-sectional view taken along line  31 - 31  in  FIG. 30  in accordance with an aspect of the present invention. 
         FIG. 32  is a perspective view of the system of  FIG. 24  showing the system connected to a vial and a syringe adapter in accordance with an aspect of the present invention. 
         FIG. 33  is an exploded perspective view of the system of  FIG. 24  showing the system along with a vial and a syringe adapter in accordance with an aspect of the present invention. 
         FIG. 34  is a front view of the system of  FIG. 24  showing the system connected to a vial and a syringe adapter in accordance with an aspect of the present invention. 
         FIG. 35  is a cross-sectional view taken along line  35 - 35  in  FIG. 34  showing the system connected to a vial and a syringe adapter in accordance with an aspect of the present invention. 
         FIG. 36  is a perspective view of a vial adapter in accordance with a further aspect of the present invention, showing the vial adapter secured to a vial in an expanded state. 
         FIG. 37  is a perspective view of the vial adapter of  FIG. 36  showing the vial adapter in an expanded state in accordance with an aspect of the present invention. 
         FIG. 38  is a perspective view of the vial adapter of  FIG. 36  showing the vial adapter in an unexpanded state in accordance with an aspect of the present invention. 
         FIG. 39  is a perspective view of a vial adapter in accordance with an aspect of the present invention, showing the vial adapter in an expanded state. 
         FIG. 40  is a perspective view of the vial adapter of  FIG. 39  showing the vial adapter in an unexpanded state in accordance with an aspect of the present invention. 
     
    
    
     Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate exemplary aspects of the disclosure, and such exemplifications are not to be construed as limiting the scope of the disclosure in any manner. 
     DETAILED DESCRIPTION 
     The following description is provided to enable those skilled in the art to make and use the described aspects contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention. 
     For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary aspects of the invention. Hence, specific dimensions and other physical characteristics related to the aspects disclosed herein are not to be considered as limiting. 
     In the following discussion, “distal” refers to a direction generally toward an end of a vial access device adapted for contact with a container, such as a vial, and “proximal” refers to the opposite direction of distal, i.e., away from the end of a vial access device adapted for engagement with the container. For purposes of this disclosure, the above-mentioned references are used in the description of the components of a vial access device in accordance with the present disclosure. 
       FIGS. 1-23  illustrate an exemplary aspect of the present disclosure. Referring to  FIGS. 1 and 2 , a system  10  for the closed transfer of fluids includes a vial access device  12  and an adapter  14  sized for movement within the vial access device  12  as described in more detail below. In one aspect, vial access device  12  includes outer housing  16 , inner housing  18 , connector  20 , top cap housing  22 , and pressure equalization system  24 . System  10  provides a device capable of accommodating a plurality of vials having different sizes. System  10  also provides substantially leak-proof sealing and pressure equalization during engagement of a cannula with a vial, during transfer of a substance from a vial chamber to a barrel chamber via the cannula, and during disengagement of the cannula from the vial. The leak-proof sealing of the system  10  substantially prevents leakage of both air and liquid during use of the system  10 . System  10  is compatible with a needle and syringe assembly for accessing a medication contained within a vial for administering the medication to a patient. System  10  is also compatible to be used with a drug reconstitution system. 
     Referring to  FIGS. 1-4C , vial access device  12  includes a vial access housing  26  having outer housing  16  and inner housing  18 . System  10  provides a device capable of accommodating a plurality of vials having different sizes. Vial access device  12  is configured to establish fluid communication between a first container, e.g., a first vial having a first vial size, and a second container, e.g., an injector and/or syringe assembly. For example, vial access device  12  is attachable to a first vial  80  as described in more detail below. Referring to  FIGS. 16-19 , first vial  80  defining a first vial size  81  may be a standard drug vial of any type having an open head portion  83  covered by a pierceable septum  84  of an elastomeric material. Walls  85  of first vial  80  define a vial chamber  86  for containing a first substance  88 . First vial  80  includes a flange  87  located adjacent open head portion  83 . Vial septum  84  is engaged with head portion  83  of first vial  80  to seal the first substance  88  within vial chamber  86 . Furthermore, adapter  14  of system  10  is configured to establish fluid communication between a first container, e.g., a second vial having a second vial size, and a second container, e.g., an injector and/or syringe assembly. For example, adapter  14  of system  10  is attachable to a second vial  90  as described in more detail below. Referring to  FIGS. 13-15 , second vial  90  defining a second vial size  91  may be a standard drug vial of any type having an open head portion  93  covered by a pierceable septum  94  of an elastomeric material. Walls  95  of second vial  90  define a vial chamber  96  for containing a second substance  98 . Second vial  90  includes a flange  97  located adjacent open head portion  93 . Vial septum  94  is engaged with head portion  93  of second vial  90  to seal the second substance  98  within vial chamber  96 . 
     Referring to  FIGS. 5A and 5B , outer housing  16  generally includes a first or proximal end  30 ; an opposing second or distal end  32 ; an outer annular ring portion  34 ; an inner neck portion  36  having a first region  38 , a second region  40 , and a third region  42 ; a first shoulder  44  disposed between first region  38  and second region  40 ; a second shoulder  46  disposed between second region  40  and third region  42 ; a wall  48  defining an elongate aperture  50 ; and a vial connection element  52  comprising vial grip members  54 , hook protrusions  56 , and angled walls  58 . 
     Referring to  FIG. 5B , inner neck portion  36  of outer housing  16  includes first region  38 , second region  40 , and third region  42 . Outer annular ring portion  34  extends from first region  38  as shown in  FIG. 5B . First shoulder  44  is disposed between first region  38  and second region  40  and is configured to provide an engagement surface with a flange portion  166  of a pressure equalization housing  160  as shown in  FIG. 7 . Second shoulder  46  is disposed between second region  40  and third region  42  and is configured to provide an engagement surface with a horizontal wall  110  of inner housing  18  as shown in  FIG. 6C . Vertical wall  48  of third region  42  defines elongate aperture  50 . Referring to  FIG. 7 , in one aspect, vertical wall  48  defines elongate aperture  50  between an aperture proximal end  64  and an aperture distal end  66 . 
     Referring to  FIG. 5B , a vial connection element  52  is disposed at second end  32  of outer housing  16 . In one aspect, vial connection element  52  includes a plurality of vial grip members  54  having hook protrusions  56  and angled walls  58 . In one aspect, vial grip members  54  are elastically deformable. Vial grip members  54  are attachable to a first vial  80  to secure vial access device  12  to the first vial  80 . Each vial grip member  54  includes a hook protrusion  56  arranged to engage a corresponding flange  87  on a container such as first vial  80  as shown in  FIG. 18 . Vial connection element  52  of vial access device  12  may be dimensioned to be attached to containers of any size and volume. In other aspects, vial connection element  52  of vial access device  12  may include other connection mechanisms for securing vial access device  12  to first vial  80  such as a threaded portion, a snap fit mechanism, locking tabs, or other similar mechanism. Each vial grip member  54  includes an angled wall  58  arranged to provide a lead-in surface to center and align vial access device  12  on a vial. 
     Referring to  FIG. 5B , a locking member or adapter engagement portion  68  is disposed on an interior surface  70  of wall  48  at second end  32  of outer housing  16 . Adapter engagement portion  68  acts as a physical barrier to prevent adapter  14  from being removed from within elongate aperture  50 . Adapter  14  is sized for movement within elongate aperture  50  of vial access housing  26  and adapter engagement portion  68  prevents adapter  14  from being removed from elongate aperture  50 . In one aspect, adapter engagement portion  68  comprises a protrusion. 
     Referring to  FIG. 5B , outer annular ring portion  34  of outer housing  16  includes an annular groove  60  for receiving an annular protrusion  112  of inner housing  18 , as described in more detail below. Outer annular ring portion  34  also includes a pressure equalization receiving area  62  for receiving pressure equalization system  24  as described in more detail below. 
     Referring to  FIGS. 6A-6D , inner housing  18  generally includes a first or proximal end  100 ; an opposing second or distal end  102 ; a first region  104  and a second region  106 ; a first shoulder  108  disposed between first region  104  and second region  106 ; horizontal wall  110  disposed between first region  104  and second region  106 ; annular protrusion  112  disposed at first end  100 ; a first region wall  113  defining a cavity  114 ; a first groove cavity  116  and a second groove cavity  118  within an adapter receiving portion  120 ; a second region wall  121 ; a spike member  122  including a piercing tip  124 ; and a fluid transfer channel  126 . 
     Referring to  FIG. 6C , inner housing  18  includes first region  104  and second region  106 . First shoulder  108  is disposed between first region  104  and second region  106  and is configured to engage second shoulder  46  of outer housing  16  as shown in  FIG. 7 . In this manner, second shoulder  46  of outer housing  16  acts as a physical barrier to prevent inner housing  18  from significant relative movement relative to outer housing  16  as shown in  FIG. 7 . 
     Referring to  FIG. 6C , annular protrusion  112  extends downward from first end  100  of inner housing  18 . Referring to  FIG. 7 , annular protrusion  112  of inner housing  18  is received within annular groove  60  of annular ring portion  34  of outer housing  16 . In this manner, the engagement of annular protrusion  112  of inner housing  18  within annular groove  60  of outer housing  16  secures inner housing  18  to outer housing  16  and prevents inner housing  18  from significant relative movement relative to outer housing  16  as shown in  FIG. 7 . 
     Referring to  FIG. 6C , horizontal wall  110  is disposed between first region  104  and second region  106 . Referring to  FIG. 7 , horizontal wall  110  together with vertical wall  48  of outer housing  16  defines elongate aperture  50  between an aperture proximal end  64  and an aperture distal end  66 . 
     Referring to  FIG. 6C , protruding out from second region wall  121  at second end  102  of inner housing  18  is a piercing member or spike member  122  which includes piercing tip  124 . Referring to  FIG. 6C , a fluid transfer channel  126  extends through spike member  122  and adapter receiving portion  120  such that piercing tip  124  is in fluid communication with cavity  114  of inner housing  18 . The purpose of fluid transfer channel  126  is to permit a needle cannula to extend through vial access device  12  and to thereby permit fluid to be transferred through vial access device  12 . In other aspects, fluid transfer channel  126  may be embodied as any other suitable fluid transfer channel arrangement. 
     Referring to  FIG. 6C , first region wall  113  defines cavity  114 . Cavity  114  receives connector  20  and top cap housing  22  as shown in  FIG. 4B . In one aspect, cavity  114  receives top cap housing  22  by an interference fit between the exterior wall surface of a sidewall  154  of top cap housing  22  and the interior wall surface of first region wall  113  as shown in  FIGS. 4B and 4C . First groove cavity  116  and second groove cavity  118  also receive respective bottom protrusions  136  of connector  20  as shown in  FIGS. 4C and 11 . In this manner, the engagement of bottom protrusions  136  of connector  20  within respective first groove cavity  116  and second groove cavity  118  secures connector  20  to inner housing  18  and prevents connector  20  from significant relative movement relative to inner housing  18  as shown in  FIGS. 4B and 4C . 
     Referring to  FIGS. 4B, 4C, and 7 , as described above, inner housing  18  is attachable to outer housing  16  by first shoulder  108  of inner housing  18  engaging second shoulder  46  of outer housing  16  and by annular protrusion  112  of inner housing  18  being received within annular groove  60  of outer housing  16 . In this manner, inner housing  18  is secured to outer housing  16  and inner housing  18  is prevented from significant relative movement relative to outer housing  16 . 
     In one aspect, outer housing  16  and inner housing  18  may form a single integral component. In another aspect, outer housing  16  and inner housing  18  are separate components and inner housing  18  is attachable to outer housing  16  such that significant relative movement between outer housing  16  and inner housing  18  is prevented. 
     Referring to  FIG. 7 , with inner housing  18  secured to outer housing  16 , spike member  122  extends in a direction substantially parallel with the plurality of vial grip members  54 . Spike member  122  serves the purpose of piercing a fluid container such as first vial  80  during assembly of vial access device  12  to first vial  80  as shown in  FIG. 18  and also serves the purpose of piercing a fluid container such as second vial  90  during assembly of vial access device  12  to second vial  90  as shown in  FIG. 15 . 
     Referring to  FIGS. 8A-8G , in one aspect, connector  20  generally includes a first or proximal end  130 ; an opposing second or distal end  132 ; a membrane cavity  134  located at first end  130 ; a bottom protrusion  136  located at second end  132 ; and a locking groove  138 . In other aspects, connector  20  comprises other connectors which are compatible with a closed system drug transfer device. 
     Referring to  FIGS. 4B and 4C , as described above, connector  20  is attachable to inner housing  18  by cavity  114  of inner housing  18  receiving connector  20  and first groove cavity  116  and second groove cavity  118  also receiving respective bottom protrusions  136  of connector  20 . In this manner, the engagement of bottom protrusions  136  of connector  20  within respective first groove cavity  116  and second groove cavity  118  secures connector  20  to inner housing  18  and prevents connector  20  from significant relative movement relative to inner housing  18  as shown in  FIGS. 4B and 4C . 
     Referring to  FIG. 8A , connector  20  includes a connection element or connection system  140 . In one aspect, connection system  140  comprises locking groove  138 . Locking groove  138  of connector  20  is engageable with a portion of an injector or injector adapter, e.g., injector  27  ( FIGS. 20 and 21 ), to secure the injector  27  to connector  20  and vial access device  12 . Connection system  140  of connector  20  provides a secured attachment between vial access device  12  and an injector such that significant relative movement between the injector and vial access device  12  is prevented and such that a cannula of the injector is maintained in a leak-proof sealing system throughout the process of engaging the cannula with a vial. Although a specific arrangement for the connector  20  is shown, the connector  20  may be embodied as any other suitable connection arrangement. 
     Referring to  FIGS. 4B and 4C , in one aspect, membrane cavity  134  of connector  20  may contain a pierceable barrier member. In other aspects, other suitable barrier members may be utilized. The pierceable barrier member provides for a liquid and gas tight seal between a piercing member and the pierceable barrier member during fluid transfer to minimize leakage and thereby prevent exposure of hazardous medicaments to a user. The pierceable barrier member provides a self-sealing seal that, with vial access device  12  attached to a vial, provides a leak-proof seal preventing any substance contained within the vial chamber from being exposed to a health care provider reconstituting, transporting, or administering a drug using system  10 . In one aspect, the pierceable barrier member comprises a resilient material. For example, the pierceable barrier member is preferably a unitary device molded of any flexible, elastomeric material conventionally used for fabricating gas-proof closures. The pierceable barrier member may be formed of a natural rubber material, polyurethane elastomers, butyl rubbers, or similar materials. It is contemplated that the pierceable barrier member is formed of a material having a Shore A hardness of approximately 10 to 50. It is also envisioned that the pierceable barrier member can have other material hardness values that would provide an appropriate self-sealing material to provide a leak-proof seal with a vial septum of a vial and an injector, thereby preventing any liquid or medication residue from being exposed to a health care provider reconstituting, transporting, or administering a drug using system  10 . 
       FIGS. 9A and 9B  illustrate another exemplary aspect of a connector of the present disclosure. The aspect illustrated in  FIGS. 9A and 9B  includes similar components to the aspect illustrated in  FIGS. 8A-8G , and the similar components are denoted by a reference number followed by the letter A. For the sake of brevity, these similar components and the similar steps of using connector  20 A ( FIGS. 9A and 9B ) will not all be discussed in conjunction with the aspect illustrated in  FIGS. 9A and 9B . 
     Referring to  FIGS. 9A and 9B , in one aspect, connector  20 A includes a bottom aperture  142 . Connector  20 A is attachable to inner housing  18  by cavity  114  of inner housing  18  receiving connector  20 A and bottom aperture  142  of connector  20 A being locked over a protrusion on inner housing  18  to secure connector  20 A to inner housing  18  and prevent connector  20 A from significant relative movement relative to inner housing  18 . 
     Referring to  FIG. 10 , in one aspect, top cap housing  22  generally includes a first or proximal end  150 ; an opposing second or distal end  152 ; a sidewall  154  extending between first end  150  and second end  152  and defining a connector receiving portion  156 ; and a handle portion  158 . In other aspects, top cap housing  22  comprises other covers which are compatible with a closed system drug transfer device. For example, top cap housing  22  may be embodied as any other suitable cover arrangement. 
     Referring to  FIGS. 4B and 4C , as described above, top cap housing  22  is attachable to first end  100  of inner housing  18  by cavity  114  of inner housing  18  receiving top cap housing  22  by an interference fit between the exterior wall surface of sidewall  154  of top cap housing  22  and the interior wall surface of first region wall  113  as shown in  FIGS. 4B and 4C . With connector  20  and top cap housing  22  properly positioned within inner housing  18 , first end  130  of connector  20  is received within connector receiving portion  156  of top cap housing  22  as shown in  FIGS. 4B and 4C . 
     With top cap housing  22  properly secured to inner housing  18  as described above, the top cap housing seals vial access device  12 , i.e., top cap housing  22  provides a substantially impermeable enclosure with respect to vial access device  12 , provides a leak prevention and protection enclosure, protects the contents of vial access device  12 , and/or maintains a sealed, sterilized environment within vial access device  12 . Top cap housing  22  provides a sufficient seal at a range of temperatures, pressures, and humidity levels. 
     Referring to  FIGS. 1, 4B, 4C, 7, and 19 , pressure equalization system  24  includes a pressure equalization housing  160  and an expandable balloon  162  which includes an expansion chamber  164 . Pressure equalization housing  160  also includes a flange portion  166 . Expandable balloon  162  includes a variable volume. Pressure equalization housing  160  comprises a relatively rigid material and expandable balloon  162  comprises a relatively flexible material. In one aspect, expandable balloon  162  comprises a thin, transparent plastic film that is attached to pressure equalization housing  160  in a gastight manner. In one aspect, expandable balloon  162  is designed as a bellow which is compressible and extendable and thus the volume of the expansion chamber  164  of expandable balloon  162  can thereby be increased and decreased. In one aspect, pressure equalization housing  160  extends radially around inner housing  18  and expandable balloon  162  extends radially around inner housing  18 . In one aspect, expandable balloon  162  comprises a toroidal shape. In other aspects, pressure equalization system  24  comprises other pressure equalization systems which are compatible with a closed system drug transfer device. 
     Pressure equalization housing  160  provides a barrier wall member that protects expandable balloon  162  from being torn during engagement of a cannula with a vial, during transfer of a substance from a vial chamber to a barrel chamber, e.g., a barrel assembly  28  ( FIGS. 20-23 ), via the cannula, and during disengagement of the cannula from the vial. In one aspect, by having expandable balloon  162  extending radially around the entirety of inner housing  18  of vial access device  12 , the vial access device  12  is balanced such that a center of mass is positioned at about a longitudinal axis of vial access device  12 . In one aspect, expandable balloon  162  extends three-hundred sixty degrees (360°) radially around inner housing  18  of vial access device  12 . In one aspect, a portion of expandable balloon  162  is not covered by pressure equalization housing  160 . In this manner, expandable balloon  162  is capable of expanding in an axial direction. 
     As discussed above, pressure equalization housing  160  is received within outer housing  16  such that first shoulder  44  of outer housing  16  provides an engagement surface with flange portion  166  of pressure equalization housing  160  as shown in  FIGS. 4B and 4C . In one aspect, pressure equalization housing  160  and outer housing  16  are a single integral component. In another aspect, pressure equalization housing  160  and outer housing  16  are separate components and pressure equalization housing  160  is attachable to outer housing  16  such that significant relative movement between pressure equalization housing  160  and outer housing  16  is prevented. 
     In one aspect, a pressure normalization channel extends from piercing tip  124  to expandable balloon  162 . In this manner, the pressure normalization channel is arranged to provide gas communication between the expandable balloon  162  and the interior of a vial when vial access device  12  is connected to a vial. The pressure normalization channel may be embodied as any suitable pressure normalization channel arrangement. With vial access device  12  connected to a vial, a syringe, cannula assembly, or injector, e.g., injector  27  ( FIGS. 20 and 21 ), may be used to inject fluid into the vial or to withdraw fluid therefrom. 
     Although a specific arrangement for the pressure equalization system  24  is shown, the pressure equalization system  24  may be embodied as any other suitable pressure equalization system arrangement. 
     The function and advantages of pressure equalization system  24 , according to the present disclosure, will be described in greater detail. When preparing and administering drugs, care has to be taken to minimize, or preferably eliminate, the risk of exposing people, such as medical and pharmacological personnel, to toxic substances. Some drugs must be dissolved or diluted before they are administered, which involves transferring a solvent from one container to a sealed vial containing the drug in powder or liquid form, by means of a needle, for example. Drugs may be inadvertently released into the atmosphere in gas form or by way of aerosolization during the withdrawal of the needle from the vial and while the needle is inside the vial if any differential pressure exists between the interior of the vial and surrounding atmosphere. Vial access device  12  of the present disclosure eliminates this problem by using pressure equalization system  24  of vial access device  12  that may be attached to a vial during the preparation of drugs. The pressure equalization system  24  includes an expandable balloon  162  which is in communication with the interior of a vial which ensures that neither an increased pressure nor a vacuum can occur inside the vial, e.g., first vial  80  ( FIGS. 16-19 ) or second vial  90  ( FIGS. 13-15 ), when gas or liquid is injected into or withdrawn from the vial. In one aspect, the expandable balloon  162  may be filled with cleaned or sterilized air prior to its use to ensure that the contents of the vial do not become contaminated with air-borne particles such as dust, pollen, mold, bacteria, or other undesirable substances. 
     Referring to  FIGS. 16-19, 20, and 21 , the vial access device  12  may be secured to a cannula of injector  27  which in turn can be connected to a fluid container, such as barrel assembly  28 , and the vial access device  12  can also be assembled via its vial connection elements  52  with a second fluid container, such as a first vial  80 . As vial access device  12  is assembled with the first vial  80 , the piercing tip  124  of the spike member  122  is pierced through a septum  84  of the first vial  80 . First vial  80  may be a standard drug vial of any type having an open head portion covered by a pierceable septum of an elastomeric material. As discussed above, the plurality of vial grip members  54  fixedly connect vial access device  12  to the first vial  80  as the hook protrusions  56  of vial grip members  54  engage the corresponding flange  87  on first vial  80  as shown in  FIG. 18 . After assembly, a user is able to insert fluid into the first vial  80 , or optionally, to retract fluid from the first vial  80 . 
     As a fluid is inserted into the first vial  80 , using the cannula of injector  27  and barrel assembly  28  ( FIGS. 20-23 ), an overpressure is created inside the first vial  80 . The pressure equalization system  24  of vial access device  12  permits pressure equalization between the first vial  80  and the expandable balloon  162 . The pressure normalization channel of the pressure equalization system  24  normalizes the pressure inside the first vial  80  by relieving the pressure inside the first vial  80  to the expansion chamber  164  of the expandable balloon  162  as shown in  FIG. 19 . 
     Referring to  FIGS. 12A-12H, 15, and 18 , adapter  14  generally includes a first or proximal end  170 ; an opposing second or distal end  172 ; guide channels  174 ; a vial connection element  176  comprising adapter vial grip members  178 , hook protrusions  180 , and angled walls  182 ; and locking members or outer housing engagement portions  184 . Adapter  14  is sized and shaped for movement within the elongate aperture  50  of vial access housing  26  and the adapter  14  is transitionable between a first position ( FIGS. 13-15 ) in which the adapter  14  is adjacent the aperture distal end  66  of the vial access housing  26  and the adapter  14  is attachable to a second vial  90  defining a second vial size  91 , the second vial size  91  different than the first vial size  81  of first vial  80 , and a second position ( FIGS. 16-18 ) in which the adapter  14  is adjacent the aperture proximal end  64  of the vial access housing  26  and the vial connection element  52  of the vial access device  12  is attachable to the first vial  80 . 
     Referring to  FIGS. 12B and 15 , a vial connection element  176  is disposed at second end  172  of adapter  14 . In one aspect, vial connection element  176  includes a plurality of adapter vial grip members  178  having hook protrusions  180  and angled walls  182 . In one aspect, adapter vial grip members  178  are elastically deformable. Adapter vial grip members  178  are attachable to a second vial  90  to secure vial access device  12  to the second vial  90  via adapter  14 . In this manner, vial access device  12  and adapter  14  provide a system  10  that is capable of accommodating a plurality of vials having different sizes, e.g., first vial  80  having first vial size  81  and second vial  90  having second vial size  91 . Each adapter vial grip member  178  includes a hook protrusion  180  arranged to engage a corresponding flange  97  on a container such as second vial  90  as shown in  FIG. 15 . Vial connection element  176  of adapter  14  may be dimensioned to be attached to containers of any size and volume. In other aspects, vial connection element  176  of adapter  14  may include other connection mechanisms for securing adapter  14  and vial access device  12  to second vial  90  such as a threaded portion, a snap fit mechanism, locking tabs, or other similar mechanism. Each adapter vial grip member  178  includes an angled wall  182  arranged to provide a lead-in surface to center and align vial access device  12  on a vial. 
     As discussed above, vial access device  12  and adapter  14  provide a system  10  that is capable of accommodating a plurality of vials having different sizes, e.g., first vial  80  having first vial size  81  and second vial  90  having second vial size  91 . In one aspect, it is envisioned that vial access device  12  and adapter  14  are compatible with a first vial  80  comprising a 20 mm vial and a second vial  90  comprising a 13 mm vial. In another aspect, it is envisioned that vial access device  12  and adapter  14  are compatible with a first vial  80  comprising a 28 mm vial and a second vial  90  comprising a 20 mm vial. In another aspect, it is envisioned that vial access device  12  and adapter  14  are compatible with a first vial  80  comprising a 32 mm vial and a second vial  90  comprising a 28 mm vial. In other aspects, it is envisioned that vial access device  12  and adapter  14  are compatible with a first vial  80  comprising other vial sizes and a second vial  90  comprising other vial sizes, wherein the second vial size is less than the first vial size. 
     Referring to  FIG. 4D , in one aspect, guide channels  174  of adapter  14  are configured to engage corresponding guiding protrusions  71  within elongate aperture  50  of outer housing  16 . In this manner, the corresponding guiding surfaces of adapter  14  and outer housing  16  provide a guided, controlled movement of adapter  14  between the first position ( FIGS. 13-15 ) and the second position ( FIGS. 16-18 ) and establish a secure attachment between the adapter  14  and the outer housing  16  as shown in  FIGS. 15 and 18 . 
     Referring to  FIGS. 4D and 15 , locking members or outer housing engagement portions  184  of adapter  14  engage adapter engagement portions  68  which act as a physical barrier to prevent adapter  14  from being removed from within elongate aperture  50 . Adapter  14  is sized for movement within elongate aperture  50  of vial access housing  26  and engagement of adapter engagement portions  68  with locking members  184  of adapter  14  prevents adapter  14  from being removed from elongate aperture  50 . 
     Referring to  FIGS. 15 and 18 , the use of vial access device  12  and adapter  14  to provide a system  10  that is capable of accommodating a plurality of vials having different sizes, e.g., first vial  80  having first vial size  81  and second vial  90  having second vial size  91 , will now be described. 
     Referring to  FIG. 15 , with the adapter  14  in the first position, the adapter  14  is adjacent the aperture distal end  66  of the vial access housing  26  and the adapter  14  is attachable to the second vial  90  defining the second vial size  91  as described above. With the vial access device  12  attachable to the second vial  90  via the adapter  14 , the spike member  122  is in fluid communication with vial chamber  96  of the second vial  90  as shown in  FIG. 15 . With the vial access device  12  attached to the second vial  90  via the adapter  14 , system  10  provides substantially leak-proof sealing and pressure equalization during engagement of a cannula of injector  27  with second vial  90  during transfer of a substance from vial chamber  96  to a barrel chamber of barrel assembly  28  via the cannula, and during disengagement of the cannula from the second vial  90 . The leak-proof sealing of the system  10  substantially prevents leakage of both air and liquid during use of the system  10 . System  10  is compatible with a needle and syringe assembly for accessing a medication contained within a vial for administering the medication to a patient. System  10  is also compatible to be used with a drug reconstitution system. Furthermore, as a fluid is inserted into the second vial  90 , using the cannula of injector  27  and barrel assembly  28  ( FIGS. 20-23 ), an overpressure is created inside the second vial  90 . The pressure equalization system  24  of vial access device  12  permits pressure equalization between the second vial  90  and the expandable balloon  162 . The pressure normalization channel of the pressure equalization system  24  normalizes the pressure inside the second vial  90  by relieving the pressure inside the second vial  90  to the expansion chamber  164  of the expandable balloon  162  as shown in  FIG. 19 . 
     As discussed above, adapter  14  is sized and shaped for movement within the elongate aperture  50  of vial access housing  26  and the adapter  14  is transitionable between the first position ( FIGS. 13-15 ) and the second position ( FIGS. 16-18 ). 
     Referring to  FIG. 18 , with the adapter  14  in the second position, the adapter  14  is adjacent the aperture proximal end  64  of the vial access housing  26  and the vial connection element  52  of the vial access device  12  is attachable to the first vial  80  as described above. With the adapter  14  in the second position, the adapter  14  is disposed above the vial connection element  52  of the vial access device  12 . In this manner, the adapter  14  is out of the way of the vial connection element  52  and the vial connection element  52  is attachable to the first vial  80 . With the vial access device  12  attachable to the first vial  80 , the spike member  122  is in fluid communication with vial chamber  86  of the first vial  80  as shown in  FIG. 18 . With the vial access device  12  attached to the first vial  80 , system  10  provides substantially leak-proof sealing and pressure equalization during engagement of a cannula of injector  27  with first vial  80 , during transfer of a substance from vial chamber  86  to a barrel chamber of barrel assembly  28  via the cannula, and during disengagement of the cannula from the first vial  80 . The leak-proof sealing of the system  10  substantially prevents leakage of both air and liquid during use of the system  10 . System  10  is compatible with a needle and syringe assembly for accessing a medication contained within a vial for administering the medication to a patient. System  10  is also compatible to be used with a drug reconstitution system. Furthermore, as a fluid is inserted into the first vial  80 , using the cannula of injector  27  and barrel assembly  28  ( FIGS. 20-23 ), an overpressure is created inside the first vial  80 . The pressure equalization system  24  of vial access device  12  permits pressure equalization between the first vial  80  and the expandable balloon  162 . The pressure normalization channel of the pressure equalization system  24  normalizes the pressure inside the first vial  80  by relieving the pressure inside the first vial  80  to the expansion chamber  164  of the expandable balloon  162  as shown in  FIG. 19 . 
     Referring to  FIGS. 24-27 , a further aspect of a vial access device  200  is shown. The vial access device  200  is similar to the vial access device  12  described above and will operate in the same manner. The vial access device  200  also includes an outer housing  216 , inner housing  218 , connector  220 , top cap  222 , a pressure equalization system  224 , and a vial connection element  252 . 
     The outer housing  216  defines an annular space  226  that receives the pressure equalization system  224 . The outer housing  216  also defines an inner space  228  that receives at least a portion of the inner housing  218  and the connector  220 . The inner housing  218  includes a body  230  having a curved top surface and a cylindrical portion  232  extending in a longitudinal direction. The body  230  defines a central opening  234  that receives at least a portion of the top cap  222 , the connector  220 , and the vial connection element  252 . The inner housing  218  is secured to the outer housing  216  by a snap-fit connection, although any other suitable securing arrangement may be utilized, such as adhesive, welding, etc. The top cap  222  includes a body  236  that defines a recessed portion  238  that receives a portion of the connector  220 . The body  236  also includes an extension portion that defines a gripping surface  240  that is configured to facilitate grasping of the top cap  222  to remove the top cap  222  from the inner housing  218 . The gripping surface  240  is shown as a recessed area of the body  230 , although any other suitable arrangement may be utilized, such as a textured surface, a protrusion, dimples, etc. The top cap  222  is secured to the inner housing  218  via a snap-fit connection, although any other suitable securing arrangement may be utilized. The pressure equalization system  224  includes a toroidal balloon  242  positioned within annular space  226  of the outer housing  216 . As discussed above in connection with the pressure equalization system  24 , the balloon  242  is configured to expand and contract to change the volume defined by the balloon  242  and the outer housing  216 . In particular, the balloon  242  is configured to expand axially outward from the annular space  226 . 
     The connector  220  is positioned within inner space  228  of the outer housing  216  and the central opening  234  of the inner housing  218 . As discussed above in connection with connector  20 , the connector  220  is configured to mate with a mating connector or component. The connector  220  includes a body  244  defining a central passageway  246 . A flange  248  extends radially outward from the body  244  of the connector  220 . A membrane or septum  250  is positioned and secured at a proximal end of the connector  220  and closes the central passageway  246 . The flange  248  abuts a ledge  254  defined by the outer housing  216  and defines an annular filter space  256  that receives an annular filter  258 . The flange  248  may be secured to the outer housing  216  via snap-fit connection, although any other suitable securing arrangement may be utilized. The filter  258  is hydrophobic filter that prevents liquid flow, but allows air to flow through during operations of the pressure equalization system  224 . 
     Referring again  FIGS. 24-27 , the vial connection element  252  is similar to the vial connection element  52  described above. The vial connection element  252  includes a body  260  having vial grip members  262  extending from the  260 . The vial connection element  252  is configured to be secured to a vial thereby securing the vial access device  200  to the vial. The body  260  of the vial connection element  252  is cylindrical and received within the central passageway  246  of the connector  220 . The body  260  defines a central passageway  264  that is aligned with the central passageway  246  of the connector  220 . The vial connection element  252  includes a spike member  266  that is configured to puncture a septum of vial as discussed above in connection with system  10 . The spike member  262  defines a fluid passageway  268  in fluid communication with the central passageways  246 ,  264  of the connector  220  and the vial connection element  252 . The spike member  262  also defines a vent passageway  270  in fluid communication with the filter space  256  and the annular space  226  of the outer housing  216 . The fluid passageway  268  is configured to facilitate the transfer of fluids to and from a vial to a mating device connected to the connector  220 . The vent passageway  270  is configured to cooperate with the pressure equalization system  224 , as discussed above in connection with system  10 , to prevent a vial from being pressurized or depressurized during the transfer of contents to and from the vial. The filter  258  prevents the passage of liquids into the filter space  256  and into the annular space  226 . 
     Referring to  FIGS. 25 and 27 , an O-ring  272  may be positioned between the connector  220  and the vial connection element  252  where the connector  220  and the vial connection element  252  are joined and where the central passageways  246 ,  264  come into alignment. The vial access device  200  also includes a sleeve member  274  positioned over the spike member  266 , which prevents leakage during fluid transfer when longer openings are used for the spike member  266  to optimize evacuation of the vial. 
     Although a specific arrangement for the connector  220  is shown, the connector  220  may be embodied as any other suitable connection arrangement. 
     Referring to  FIGS. 28-31 , the vial access device  200  may be provided with a packaging arrangement  208 . The packaging arrangement  208  holds the vial access device  200  and maintains sterility prior to use, but can also be used to hold the vial access device  200  while connecting the vial access device  200  onto a container, such as a vial.  FIG. 31  shows a configuration without the top cap  222  and where a portion of the packaging arrangement  208  engages the inner housing  218 . 
     Referring to  FIGS. 32-35 , the vial access device  200  is shown in use with a syringe adapter  210  and the vial  80 . The syringe adapter  210  may be the syringe adapter and system noted above in connection with connector  20 . The syringe adapter  210  cooperates with the connector  220  to facilitate the sealed transfer of substances between the vial  80  and a syringe (not shown) connected to the syringe adapter  210 . 
     Referring to  FIGS. 36-38 , another aspect of a vial access device  300  is shown. The vial access device  300  is similar to the vial access device  12  described above and will operate in the same manner. The vial access device  300  includes a connector  20 , a pressure equalization system  24 , a connection element  52 , and a spike member  122 . The vial access device  300  also includes the sleeve member  274  discussed above in connection with the vial access device  200 . The pressure equalization system  24  shown in  FIGS. 36-38  is generally rectangular. 
     Referring to  FIGS. 39 and 40 , another aspect of a vial access device  400  is shown. The vial access device  400  is similar to the vial access device  300  described above and will operate in the same manner as described in connection with vial access device  12 . The vial access device  400  has a pressure equalization system that is substantially spherical. 
     While this disclosure has been described as having exemplary designs, the present disclosure can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this disclosure pertains and which fall within the limits of the appended claims.