Patent Publication Number: US-2019167526-A1

Title: Secured medication transfer system

Description:
CROSS REFERENCE TO RELATED APPLICATION 
     This application claims priority to U.S. Provisional Patent Application Ser. No. 62/377,853, filed Aug. 22, 2016, the disclosure of which is hereby expressly incorporated by reference herein in its entirety. 
    
    
     FIELD OF THE DISCLOSURE 
     The present disclosure relates to a system for transferring a medication in a secured manner, and to a method for using the same. 
     BACKGROUND OF THE DISCLOSURE 
     A vial  10  that is configured to hold a medication  11 , such as insulin or another medication, is shown in  FIG. 1 . The illustrative vial  10  includes a relatively wide flange or rim  12 , a relatively narrow neck  14  beneath flange  12 , and a slanted shoulder  16  that widens beneath neck  14 . The upper end of the illustrative vial  10  also includes a septum or stopper  18  (e.g., a rubber stopper) that seals and protects the medication in vial  10 . Stopper  18  may be generally T-shaped in cross-section, such that stopper  18  rests above flange  12  of vial  10  and extends downward into vial  10  toward neck  14 . Flange  12  includes a crimp seal  17  (e.g., aluminum material) that extends around flange  12  and stopper  18  to secure stopper  18  to vial  10  while providing top access to stopper  18  for needle  22 . A protective lid or cap  19  is coupled to the top of vial  10  over stopper  18  and is removed, such as with a user&#39;s fingers, prior to piercing stopper  18  with needle  22 . 
     A traditional syringe  20  is also shown in  FIG. 1 . The illustrative syringe  20  includes plunger  24  and a needle  22  that protrudes from syringe  20  by a length L along axis A. Syringe  20  includes a hub  23  at a distal end that secures needle  22  to syringe  20 . Hub  23  with needle  22  may be removably coupled to the body of syringe  20 , such as via a standardized connection (e.g., Luer-Lok® connection fitting), or may be integrally formed with syringe  20 . In use, needle  22  of syringe  20  punctures stopper  18  along axis A (or at a small angle relative to axis A), and plunger  24  of syringe  20  is pulled to withdraw the medication from vial  10 . In certain embodiments, syringe  20  is used to transfer the medication to a delivery device (not shown), such as an insulin pump for example. The transfer syringe  20  may be an independent component that is separate from the delivery device, as shown in  FIG. 1 , or a component that is part of a delivery device such as a pump reservoir. In other embodiments, syringe  20  is used to deliver the medication directly to a patient. 
     The concentration of the medication in vial  10  may vary. With respect to insulin, for example, vial  10  may contain 100 units of insulin per milliliter (mL) of liquid (i.e., U-100 insulin), 200 units of insulin per mL of liquid (i.e., U-200 insulin), 500 units of insulin per mL of liquid (i.e., U-500 insulin), or another suitable insulin concentration. The higher-concentration medications may have certain advantages for the patient, such as extended usage times and smaller delivery devices, tor example. However, if a higher-concentration medication is mistaken for a lower-concentration medication, the patient may be susceptible to overdose or hypoglycemia. 
     SUMMARY 
     The present disclosure provides a vial adaptor and needle assembly configured for use with a vial containing a medication, such as insulin. The vial adaptor may include a needle opening configured to receive a needle of a geometrically corresponding needle assembly hub to withdraw the medication from the vial in a secured manner. The vial adaptor may also include a cleaning passageway configured to receive a cleaning device to clean the vial stopper while blocking access to the stoppers with a needle through the cleaning passageway. In some embodiments, the vial adapter is configured to reduce the likelihood that a user transfers an incorrect insulin concentration into a delivery device. 
     According to an embodiment of the present disclosure, a vial adaptor is provided for use with a vial containing a medication and a needle assembly having a needle. The vial adaptor includes: a substantially hollow body configured to couple with the vial; a needle opening in the body, the needle opening being arranged along an axis and being sized and shaped to receive the needle along the axis to withdraw the medication from the vial; a cleaning passageway in the body, the cleaning passageway being sized and shaped to receive a cleaning device to clean the vial; and a shroud-extending outward from the body to block needle insertion into the vial through the cleaning passageway. 
     In certain embodiments, a lower end of the body includes a generally cylindrical side wall and an upper end of the body includes an upper wall, the shroud extending radially outward beyond the cylindrical side wall of the lower end of the body. 
     In certain embodiments, the shroud extends continuously from the upper wall of the body. 
     In certain embodiments, the shroud extends from the axis of the needle opening by a distance of about 20 millimeters to about 30 millimeters. 
     In certain embodiments, the cleaning passageway is offset from the axis of the needle opening between a first angle greater than 50 degrees and a second angle less than 150 degrees. The first angle may be about 60 degrees to about 70 degrees, and the second angle may be about 110 degrees to about 120 degrees. 
     In certain embodiments, an inlet to the cleaning passageway is located in a side wall of the body, the side wall extending radially outward from a lower end of the body to an upper end of the body such that the inlet to the cleaning passageway also extends radially outward from a lower end of the inlet to an upper end of the inlet. 
     In certain embodiments, an inlet to the cleaning passageway includes a notch. The notch may be positioned closer to a lower end of the inlet than an upper end of the inlet. 
     In certain embodiments, an inlet to the cleaning passageway is larger than an inlet to the needle opening. 
     In certain embodiments, the needle opening follows a linear pathway and the cleaning passageway follows a non-linear pathway. 
     In certain embodiments, the needle opening is formed is a rim, the rim having a tapered outer surface and at least one protrusion for coupling the rim to the body. 
     In certain embodiments, a needle assembly is provided including a hub having a keyed outer profile that matches the shape of the needle opening. 
     According to another embodiment of the present disclosure, a vial adaptor is provided for use with a vial containing a medication and having a relatively wide flange, a relatively narrow neck beneath the flange, and a slanted shoulder beneath the neck. The vial adaptor includes: a substantially hollow body; a needle opening in the body, the needle opening being sized and shaped to receive a needle to withdraw the medication from the vial; and a coupling assembly configured to couple the body to the vial, the coupling assembly including: a plurality of first fingers, each first finger configured to flex over the rim of the vial and release towards the neck beneath the rim of the vial; and a plurality of second fingers configured to contact the shoulder of the vial to bias the plurality of first fingers toward the rim of the vial. 
     In certain embodiments, each second finger is shorter than each first finger. 
     In certain embodiments, the body is sized to cover substantially the entire vial. The body may be at least partially transparent such that the vial is visible through the body. 
     In certain embodiments, the vial adaptor further includes a passageway in the body, the passageway being sized and shaped to at least one of receive a cleaning device to clean the vial and provide access to a cap of the vial for removal of the cap, and a shroud extending outward from the body to block needle insertion into the vial through the passageway. 
     According to yet another embodiment of the present disclosure, a method is provided for using a vial adaptor coupled to a vial. The method includes the steps of: cleaning a stopper of the vial by inserting a disinfectant-containing cleaning device through a cleaning passageway of the vial adaptor; and withdrawing a medication from the vial by insetting a needle through a needle opening of the vial adaptor and into the stopper of the vial. 
     In certain embodiments, the cleaning passageway is offset from the needle opening between a first angle greater than 50 degrees and a second angle less than 150 degrees. In certain embodiments, the method further comprises, prior to the cleaning, removing a cap from the vial through the cleaning passageway. 
     In certain embodiments, the method further includes the step of blocking needle insertion into the vial through the cleaning passageway by contacting a shroud around the cleaning passageway. 
    
    
     
       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 will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings, wherein: 
         FIG. 1  is a cross-sectional view of a vial containing a medication and a transfer syringe; 
         FIG. 2  is a front elevational view of a first exemplary vial adaptor coupled to a vial and a geometrically corresponding needle assembly, the vial adaptor shown in a non-use position; 
         FIG. 3  is a cross-sectional view of the vial adaptor and the needle assembly of  FIG. 2  shown in a use position; 
         FIG. 4  is a front elevational view of the vial adaptor of  FIG. 2 ; 
         FIG. 5  is a left side elevational view of the vial adaptor of  FIG. 2 ; 
         FIG. 6  is a right side elevational view of the vial adaptor of  FIG. 2 ; 
         FIG. 7  is a top plan view of the vial adaptor of  FIG. 2 ; 
         FIG. 8  is a bottom plan view of the vial adaptor of  FIG. 2 ; 
         FIG. 9  is an exploded perspective view of the vial adaptor of  FIG. 2 ; 
         FIG. 10  is a perspective view of the needle assembly of  FIG. 2 ; 
         FIG. 11  is a perspective view of a second exemplary vial adaptor coupled to a vial and a geometrically corresponding needle assembly, the vial adaptor shown in a non-use position; 
         FIG. 12  is a cross-sectional view of the vial adaptor and the needle assembly of  FIG. 11  shown in a use position; 
         FIG. 13  is a perspective view of a third exemplary vial adaptor coupled to a vial; 
         FIG. 14  is a cross-sectional view of the vial adaptor of  FIG. 13  and a geometrically corresponding needle assembly shown in a use position; 
         FIG. 15  is a perspective view of a fourth exemplary vial adaptor coupled to a vial; 
         FIG. 16  is a perspective view of a fifth exemplary vial adaptor shown in a cleaning position; 
         FIG. 17  is a perspective view of the vial adaptor of  FIG. 16  shown in a withdrawing position; 
         FIG. 18  is a cross-sectional view of another vial adaptor similar to the vial adaptor of  FIG. 16  and shown in a cleaning position; 
         FIG. 19  is a front elevational view of a sixth exemplary vial adaptor coupled to a vial, the vial adaptor shown in a cleaning position; 
         FIG. 20  is a perspective view of the vial adaptor of  FIG. 19  shown in a withdrawing position; 
         FIG. 21  is a front elevational view of the vial adaptor of  FIG. 20 ; 
         FIG. 22  is a detailed cross-sectional view of the vial adaptor of  FIG. 21 ; 
         FIG. 23  is a perspective view of a seventh exemplary vial adaptor coupled to a vial; 
         FIG. 24  is a cross-sectional view of the vial adaptor of  FIG. 23  and a geometrically corresponding needle assembly, the vial adaptor shown in a non-use position; 
         FIG. 25  is a cross-sectional view of the vial adaptor and the needle assembly of  FIG. 24  shown in a use position; 
         FIG. 26  is a perspective view of one half of an eighth exemplary vial adaptor; 
         FIG. 27  is an elevational view of the vial adaptor of  FIG. 26 ; 
         FIG. 28  is a plan view of two halves of the vial adaptor of  FIG. 26  coupled together with a hinge; and 
         FIG. 29  is a perspective view of two halves of the vial adaptor of  FIG. 26  coupled together with a hinge. 
     
    
    
     Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate exemplary embodiments of the invention and such exemplifications are not to be construed as limiting the scope of the invention in any manner. 
     DETAILED DESCRIPTION 
     Referring initially to  FIGS. 2-10 , a first exemplary vial adaptor  100  is shown for use with vial  10 , and a geometrically corresponding needle assembly  150  is shown for use with syringe  20  ( FIG. 1 ) or another transfer assembly (e.g., an integrated insulin pump). 
     The illustrative vial adaptor  100  includes a substantially hollow body  103  with a generally cylindrical and vertical side wall  102  and a generally flat and horizontal upper wall  108 . In the illustrated embodiment of  FIG. 9 , side wall  102  and upper wall  108  are separate components that are coupled together to form body  101 , such as by providing windows  140  in side wall  102  that receive corresponding locking tabs  142  from upper wall  108 . It is also within the scope of the present disclosure for side wall  102  and upper wall  108  to be integrally formed together. Side wall  102  and/or upper wall  108  of body  101  may be transparent to allow visibility inside vial adaptor  100 . Side wall  102  and/or upper wall  108  of body  101  may also be color-coded or otherwise labeled to visually associate vial adaptor  100  with the corresponding vial  10 . 
     Vial adaptor  100  has a lower end  104  that extends onto vial  10  and an upper end  100  that extends above vial  10 . Vial adaptor  100  also has a total height H 1  measured between lower end  104  and upper end  106  along axis A, as shown in  FIG. 3 . Side wall  102  of the illustrative vial adaptor  100  covers substantially the entire vial  10 , so the total height H 1  of vial adaptor  100  exceeds the height of vial  10  alone. For example, the total height H 1  of vial adaptor  100  may vary from about 70 millimeters (mm) to about 80 mm, such as about 73 mm for example. Of course, this total height H 1  may vary to accommodate vials  10  of different sizes. It is also within the scope of the present disclosure that side wall  102  may only partially cover vial  10 . 
     The illustrative vial adaptor  100  includes a ring-shaped coupling assembly  110  configured to couple vial adaptor  100  to vial  10 . The coupling between vial adaptor  100  and vial  10  may be performed by the supplier of vial  10  and may be permanent in nature to reduce the likelihood of subsequent removal by the end user or another intermediate party. Coupling assembly  110  may be integrally formed with side wall  102  of vial adaptor  100 , or coupling assembly  110  may be a separate component that is fixedly coupled (e.g., welded, adhered, fastened) to side wall  102  of vial adaptor  100 . The illustrative coupling assembly  110  includes a first set of relatively long and flexible fingers  112  and a second set of relatively short, U-shaped, and flexible fingers  114 , both of which extend radially inward from side wall  102  of vial adaptor  100  toward vial  10 . As vial adaptor  100  is pressed downward onto vial  10 , each finger  112  is designed to flex radially outwardly around flange  12  (including the cap and surrounding crimp seal of  FIG. 1 ) of vial  10  and then snap back or release toward neck  14 , which locks vial adaptor  100  in place beneath flange  12  and the crimp seal of vial  10 . At the same time, each finger  114  is designed to compress against shoulder  16  of vial  10 . Each compressed finger  114  is thus positioned against the narrowing, slanted shoulder  16  toward neck  14  to apply a continuous upward force to vial adaptor  100  and maintain fingers  112  against the underside of flange  12 . The flexibility of fingers  112 ,  114 , may allow coupling assembly  110  to accommodate vials  10  of different shapes and sizes. Alternatively, fingers  114  are rigid fingers  114  that abut shoulder  16  to apply a hard stop against shoulder  16 , thereby applying the continuous upward force to vial adaptor  100  and maintaining fingers  112  against the underside of flange  12 . 
     The illustrative vial adaptor  100  also includes a needle port or opening  120  that extends through upper wall  108  and follows a linear pathway along axis A. Inlet  121  of needle opening  120  may be defined by a separate rim  122  that is coupled (e.g., welded, adhered, fastened) to upper wall  108 , or inlet  121  of needle opening  120  may be formed directly by upper wall  108 . In the illustrated embodiment of  FIG. 9 , rim  122  includes a tapered outer surface  124  that matches the tapered contour of upper wall  108  and one or more protrusions  126  configured to snap into corresponding recesses  128  in upper wall  108 . An optional cap or lid (not shown) may also be provided to selectively cover inlet  121  of needle opening  120 . 
     Needle opening  120  is sized and shaped to accommodate a geometrically corresponding hub  153  of needle assembly  150 , as discussed further below, but not a needle hub of a traditional or commonly used syringe (e.g., standard hub  23  of syringe  20  of  FIG. 1 ). For example, needle opening  120  may be sized and shaped to accommodate needle assembly  150  associated with U-200 insulin, but not a standard syringe  20  typically used with U-100 insulin vials. As a result, needle opening  120  may reduce the likelihood that the standard syringe  20  associated with U-100 insulin is used to withdraw an improper or unintended medication from vial  10 , in this example U-200 insulin. Because the hub  23  of standard syringe  20  is typically circular in shape, needle opening  120  may be sized smaller than hub  23  of syringe  20  and/or may be keyed or non-circular in shape to prevent insertion of hub  23  of syringe  20 . In the illustrated embodiment of  FIG. 7 , needle opening  120  is rectangular-shaped with rounded corners, but it is also within the scope of the present disclosure for needle opening  120  to be oval-shaped, triangular-shaped, cross-shaped, star-shaped, or another suitable shape that is not compatible with a standard needle hub  23 . Also, in assembly, needle opening  120  of vial adaptor  100  is spaced apart from stopper  18  of vial  10  by a sufficient height H 2  (which is less than the total height H 1  of vial adaptor  100 ) to prevent needle  22  of the standard syringe  20  ( FIG. 1 ) from reaching stopper  18  of vial  10  when hub  23  abuts upper wall  108  or rim  122  of vial adaptor  100 . Stated differently, the height H 2  between needle opening  120  and stopper  18  may exceed the length L of needle  22  of the standard syringe  20  ( FIG. 1 ). For example, the height H 2  may vary from about 15 mm to about 25 mm, such as about 20 mm. The size and shape of needle opening  120  and the height H 2  of vial adaptor  100  may be adjusted depending on the size and shape of the particular syringe  20  or other standard transfer assembly for which access prevention is desired. 
     The illustrative vial adaptor  100  further includes a cleaning passageway  130  that is at least partially surrounded by shroud  132 . Inlet  131  of cleaning passageway  130  is shown extending through side wall  102  of body  101 , but this location may vary. Shroud  132  is shown extending radially outward from axis A as a continuous extension of upper wall  108  of body  101 , but this location may also vary. In the illustrated embodiment of  FIG. 3 , side wall  102  deviates radially outward from lower end  104  to upper end  106  to follow the path of shroud  132 . As a result, inlet  131  of cleaning passageway  130  that is defined by side wall  102  also extends radially outward from lower end  136  of inlet  131  to upper end  138  of inlet  131 . Inlet  131  of cleaning passageway  130  may also include a notch  139  to facilitate user access. In the illustrated embodiment of  FIG. 3 , the notch  139  is positioned closer to lower end  136  of inlet  131  than upper end  138  of inlet  131 . In the illustrated embodiment, lower end  136  is curved radially outwardly to facilitate access to the vial cap  19  ( FIG. 1 ) such that a user may remove cap with the user&#39;s finger or a tool. For example, the widened space between lower end  136  and stopper  18  shown in  FIG. 3  allows a user to insert a finger or tool to apply an upward force to the overhanging portion of cap  19  to pop cap  19  off of vial  10  prior to use. In other embodiments, lower end  136  is flush with the side wall  102 . 
     Cleaning passageway  130  is distinct from needle opening  120  of vial adaptor  100 . Cleaning passageway  130  is sized and shaped to allow a cleaning device (e.g., pad, wipe, swab) containing a disinfectant (e.g., alcohol), along with a user&#39;s finger, if necessary, to access and clean stopper  18  of vial  10  before use. Cleaning passageway  130  may also be used to remove any seal or cover from stopper  18  of vial  10  before use, as described above. Inlet  131  of cleaning passageway  130  is illustratively larger than inlet  121  of needle opening  120  to accommodate such cleaning devices and the user&#39;s finger, if necessary. 
     In the illustrated embodiment, unlike needle opening  120 , cleaning passageway  130  is not intended to allow a needle to access stopper  18 , such as the needle of syringe  20  ( FIG. 1 ), needle assembly  150  ( FIG. 2 ), or another medication transfer assembly. Therefore, cleaning passageway  130  and/or shroud  132  are sized and shaped to block unwanted insertion of a needle through stopper  18  via passageway  130 . Accordingly, needle opening  120  provides needle access to stopper  18  while shroud  132  blocks needle access to stopper  18  through passageway  130 . Shroud  132  may protrude from axis A by a distance D ( FIG. 3 ) of about 20 mm to about 30 mm, such as about 27 mm for example. As a result, access to stopper  18  of vial  10  through the cleaning passageway  130  may be offset from axis A between a first angle α 1  measured through upper end  138  of inlet  131  and a second angle α 2  measured through lower end  136  of inlet  131 . The first angle α 1  may be greater than about 50 degrees, more specifically about 50 degrees to about 80 degrees, and even more specifically about 60 degrees to about 70 degrees. The second angle α 2  may be less than about 150 degrees, more specifically about 90 degrees to about 150 degrees, and even more specifically about 110 degrees to about 120 degrees. The size and shape of cleaning passageway  130  and/or shroud  132  may be adjusted depending on the size and shape of the particular syringe  20 , needle, or other transfer assembly for which access prevention is desired. It is also within the scope of the present disclosure for cleaning passageway  130  to follow a non-linear pathway to further block insertion of a needle through stopper  18  via passageway  130 . 
     The illustrative needle assembly  150  has a hub  153  and a needle/cannula  152  coupled to hub  153 . Hub  153  has a keyed outer profile  154  that specifically matches the shape of needle opening  120  in the geometrically corresponding vial adaptor  100 . Because needle opening  120  in the illustrative vial adaptor  100  is rectangular-shaped, the outer profile  154  of the corresponding needle hub  153  is also rectangular-shaped, but other shapes may be provided, as discussed above. Needle assembly  150  may be removably coupled to syringe  20  of  FIG. 1  (with the standard hub  23  removed) or another standard transfer assembly. In one embodiment, syringe  20  has a female Luer-Lok® connection fitting (not shown), and hub  153  of needle assembly  150  has a male Luer-Lok® connection fitting  156 . Other suitable connections (e.g., threaded connections) may be used to removably couple needle assembly  150  to syringe  20 . It is also within the scope of the present disclosure for needle assembly  150  to be integrally formed with or permanently coupled to a syringe. The syringe used with needle assembly  150  may be calibrated or scaled based on the specific medication concentration in vial  10 , in this example U-200 insulin. 
     In use, needle assembly  150  is coupled to a syringe (e.g., syringe  20  of  FIG. 1  with hub  23  removed) or another transfer device. If necessary, cap  19  ( FIG. 1 ) of vial  10  is removed through cleaning passageway  130 , and stopper  18  is cleaned with a disinfectant. Next, needle assembly  150  is inserted into needle opening  120  of the corresponding vial adaptor  100  in a keyed manner, as shown in  FIG. 3 . In this position, needle  152  of needle assembly  150  is able to reach and puncture stopper  18  of vial  10  along axis A to withdraw the intended medication from vial  10 , in this example U-200 insulin. Finally, the withdrawn medication is transferred to a delivery device (not shown), such as an insulin pump, or delivered directly to the patient. The delivery device may include a keyed interface that matches the outer profile of needle hub  153  to receive the insulin into a reservoir of the device. 
     A set of different vial adaptors  100  and corresponding needle assemblies  150  may be provided for each available medication concentration in vial  10  ( FIG. 1 ), or at least for higher-concentration medications. For each concentration, the shape of needle opening  120  in vial adaptor  100  and outer profile  154  of the corresponding needle assembly  150  may vary. If the rectangular-shaped opening  120  and needle assembly  150  shown in  FIGS. 2-10  are provided for use with vial  10  containing U-200 insulin, for example, a differently-shaped needle opening  120  and needle assembly  150  may be provided for use vial  10  containing U-500 insulin. For ease of manufacturing, the different vial adaptors  100  may be substantially identical in size and shape, except for the provision of different rims  122  that form differently-shaped needle openings  120 . The height H 2  of vial adaptor  100  may also vary for different insulin concentrations. 
     Referring next to  FIGS. 11 and 12 , a second exemplary vial adaptor  200  and needle assembly  250  are shown for use with vial  10 . Vial adaptor  200  and needle assembly  250  are similar to the above-described vial adaptor  100  and needle assembly  150 , with like reference numerals identifying like elements, except as described below. Rather than covering substantially the entire vial  10 , side wall  202  of the illustrative vial adaptor  200  extends only to shoulder  16  of vial  10 , as shown in  FIG. 12 . In this embodiment, the total height H 1  of vial adaptor  200  measured between the shortened lower end  204  and upper end  206  may vary from about 30 mm to about 40 mm, such as about 34 mm. The total height H 1  of vial adaptor  200  may be less than the height of vial  10 . The illustrative vial adaptor  200  includes a needle opening  220  that follows a linear pathway to vial  10  and a cleaning passageway  230  that follows a non-linear pathway to vial  10 . 
     Referring next to  FIGS. 13 and 14 , a third exemplary vial adaptor  300  and needle assembly  350  are shown for use with vial  10 . Vial adaptor  300  and needle assembly  350  are similar to the above-described vial adaptors  100 ,  200  and needle assembly  150 ,  250 , with like reference numerals identifying like elements, except as described below. The illustrative vial adaptor  300  includes a lid or cap  360  configured to selectively cover needle opening  320 . Cap  360  includes a flexible hinge  362  coupled to body  301  of vial adaptor  300  and a plug  364  sized for receipt in needle opening  320  of vial adaptor  300 . When cap  360  is closed, plug  364  may be sized to contact stopper  18  of vial  10  to prevent foreign material from accessing stopper  18 . Plug  364  may also include an anti-microbial material on its surface to clean stopper  18  of vial  10  when cap  360  is closed. The illustrative vial adaptor  300  lacks a cleaning passageway distinct from needle opening  320 , so needle opening  320  may be used for both cleaning vial  10  and withdrawing medication from vial  10 . Thus, when cap  360  is opened, as shown in  FIG. 13 , stopper  18  of vial  10  may be exposed through needle opening  320  for both cleaning and withdrawing medication. 
     Referring next to  FIG. 15 , a fourth exemplary vial adaptor  400  is shown for use with vial  10 . Vial adaptor  400  is similar to the above-described vial adaptor  300 , with like reference numerals identifying like elements, except as described below. The illustrative vial adaptor  400  includes a cleaning passageway  430  in side wall  402  that is distinct from needle opening  420 . Cleaning passageway  430  is sized and shaped to allow a cleaning device (e.g., pad, wipe, swab) containing a disinfectant (e.g., alcohol), along with a user&#39;s finger (shown in broken lines), to access and clean stopper  18  of vial  10  before use. 
     Referring next to  FIGS. 16-18 , a fifth exemplary vial adaptor  500  is shown for use with vial  10 . Vial adaptor  500  is similar to the above-described vial adaptors  100 - 400 , with like reference numerals identifying like elements, except as described below. Vial adaptor  500  includes an outer body  501 , a needle opening  520 , and a distinct cleaning passageway  530 . Additionally, vial adaptor  500  includes an inner body  570  rotatably disposed within outer body  501  between a cleaning position, as shown in  FIGS. 16 and 18 , and a withdrawal position, as shown in  FIG. 17 . In the cleaning position of  FIG. 16 , inner body  570  at least partially blocks access to needle opening  520  by narrowing and/or changing the shape of needle opening  520  while permitting access to cleaning passageway  530 . In the cleaning position of  FIG. 18 , inner body  570  blocks needle opening  520  entirely while permitting, access to cleaning passageway  530 . In the withdrawal position of  FIG. 17 , inner body  570  rotates to expose needle opening  520  and block access to cleaning passageway  530 . By distinguishing the cleaning process from the withdrawal process, vial adaptor  500  may reduce the risk of an unintentional needle stick injury to a user during the cleaning process. 
     Referring next to  FIGS. 19-22 , a sixth exemplary vial adaptor  600  is shown for use with vial  10 . Vial adaptor  600  is similar to the above-described vial adaptors  100 - 500 , with like reference numerals identifying like elements, except as described below. Vial adaptor  600  includes a pivotable cover  680  that defines needle opening  620  on one end and cleaning passageway  630  on the other end. Cover  680  is rotatable between a cleaning position, shown in  FIG. 19 , and a withdrawal position, shown in  FIGS. 20 and 21 . In the cleaning position of  FIG. 19 , cover  680  rotates to a generally horizontal position. In this cleaning position, the user may be capable of accessing stopper  18  of vial  10  ( FIG. 20 ) with a cleaning device through the generally horizontal cleaning passageway  630 , but not with a needle through the generally horizontal needle opening  620 . In the withdrawal position of  FIGS. 20 and 21 , cover  680  rotates to a generally vertical position. In this withdrawal position, the user may be capable of accessing stopper  18  of vial  10  with a needle through the generally vertical needle opening  620 , but not with a cleaning device through the closed and generally vertical cleaning passageway  630 . As shown in  FIG. 22 , one or more blocking members  682  may also be provided within cover  680  to further protect stopper  18  of vial  10  in the withdrawal position, until a geometrically corresponding needle assembly (not shown) enters needle opening  620 , as discussed above, and moves (e.g., pivots) blocking member  682  out of the way. Again, by distinguishing the cleaning process from the withdrawal process, vial adaptor  600  may reduce the risk of an unintentional needle stick injury to a user during the cleaning process. 
     Vial adapter  600  is coupled to vial  10  using a coupling assembly  610  similar to the above-described coupling assembly  110  ( FIG. 3 ). The illustrative coupling assembly  610  of  FIG. 22  is positioned at or near lower end  604  of vial adapter  600  and includes a first set of relatively short and flexible fingers  612  and a second set of relatively long and flexible fingers  614 , both of which extend radially inward from side wall  602  of vial adaptor  600  toward vial  10 . As vial adaptor  600  is pressed downward onto vial  10 , each linger  612  is designed to flex around flange  12  of vial  10  and then snap back or release toward neck  14 , which locks vial adaptor  600  in place beneath flange  12  of vial  10 . At the same time, each finger  614  is designed to flex over shoulder  16  while simultaneously abutting rim  12 . Each flexed finger  614  may try to release by moving upward as far as possible along the narrowing, slanted shoulder  16  toward neck  14 , which may apply a continuous upward force to vial adaptor  100  and maintain fingers  612  in contact with rim  12 . The flexibility of fingers  612 ,  614 , may allow coupling assembly  610  to accommodate vials  10  of different shapes and sizes. 
     Referring next to  FIGS. 23-25 , a seventh exemplary vial adaptor  700  and needle assembly  750  are shown for use with vial  10 . Vial adaptor  700  and needle assembly  750  are similar to the above-described vial adaptors  100 - 600  and needle assembly  150 - 350 , with like reference numerals identifying like elements, except as described below. The illustrative vial adaptor  700  includes one or more internal blocking members  782 . The illustrative needle assembly  750  includes a needle  752  and one or more corresponding flanges  784 . In a non-use position, as shown in  FIG. 24 , blocking members  782  are biased together to protect stopper  18  of vial  10 . In a withdrawal position, as shown in  FIG. 25 , the geometrically corresponding needle assembly  750  enters needle opening  720 , and flanges  784  move blocking members  782  apart to expose stopper  18  of vial  10  to needle  752 . To clean vial  10 , a disinfectant-containing cleaning device may be inserted through a distinct cleaning passageway  730  of vial adaptor  700 , as discussed further above. Alternatively, a disinfectant-containing cleaning device that mimics the size and shape of needle assembly  750  may be provided for insertion between blocking members  782 , such that the cleaning device would take the place of needle  752 . 
     Referring next to  FIGS. 26-29 , an eighth exemplary vial adaptor  800  is shown for use with vial  10 . Vial adaptor  800  is similar to the above-described vial adaptors  100 - 700 , with like reference numerals identifying like elements, except as described below. The illustrative vial adaptor  800  includes a two-piece body made from body pieces  801 ,  801 ′. On one side, body pieces  801 ,  801 ′ may be coupled together using a flexible hinge  890 . In the illustrated embodiment of  FIG. 28 , the hinge  890  is located along side wall  802  of vial adaptor  800 . In the illustrated embodiment of  FIG. 29 , the hinge  890  is located along upper wall  808  of vial adaptor  800 . On the other side, body pieces  801 ,  801 ′ may be coupled together using one or more fasteners, such as pegs  892  on body piece  801  that are received within recesses  894  in the other body piece  801 ′. It is also within the scope of the present disclosure for the body pieces  801 ,  801 ′ to be welded, adhered, or otherwise coupled together around vial  10 . A gasket  896  may be provided that fits into neck  14  of vial  10  between flange  12  and shoulder  16 , as shown in  FIG. 27 , to seal vial adaptor  800  onto vial  10 . 
     Various features of the above-described vial adaptors  100 - 800  may be mixed and matched. For example, vial adaptor  100  of  FIGS. 2-9  may include a partial-length side wall similar to side wall  202  of  FIGS. 11 and 12 , a cap similar to cap  360  of  FIGS. 13 and 14 , a coupling assembly similar to coupling assembly  610  of  FIG. 22 , one or more blocking members similar to blocking members  782  of  FIGS. 24-25 , and/or a gasket similar to gasket  896  of  FIG. 27 . 
     While this invention has been described as having exemplary designs, the present invention 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 invention 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 invention pertains and which fall within the limits of the appended claims.