Patent Publication Number: US-11660252-B2

Title: Binary connector for reconstitution

Description:
FIELD 
     The present disclosure relates generally to the preparation and administration of intravenous solutions, and more specifically to a connector device for reconstituting a medication. 
     BACKGROUND 
     Some medications are manufactured in a concentrated liquid form that requires mixture with another liquid or “diluent” prior to being administered to a patient. Other medications are manufactured in a concentrated powder form that also requires mixture with a diluent prior to being administered to a patient. This mixing of concentrated medication with diluent, sometimes called “reconstitution”, creates a drug solution or suspension that can be administered to a patient using an intravenous (IV) bag or container. 
     Medications and diluents are often stored separately. One reason for this is that drug solutions often have a relatively short shelf life after mixing. Keeping medications and diluents separate also allows a pharmacy to bulk prepare commonly used medications for an entire facility. Therefore, it is desirable to keep the medication and diluent separate until right before the drug solution is needed. Thorough mixing of medication with a diluent can take time, however. This can delay administration of the drug solution, costing a precious amount of time for patients who require urgent treatment. 
     To address these challenges, special IV containers, referred to herein as “solution containers”, have been developed. A solution container has a port that allows concentrated medication to be transferred into the container and mixed with the diluent. This allows a drug solution to be prepared in the solution container a short time before the drug solution is needed. 
     Special adaptors have also been developed that allow concentrated medication stored in vials to be transferred into solution containers. These adaptors create fluid conduits between the drug vials and solution containers. A typical adapter has a first cannula or spike for connection to a port on a drug vial. The adapter also has a second cannula or spike for connection to a solution container. The vial spike can have a coring configuration designed to puncture a silicone septum on the drug vial and remove a piece of the septum or “plug” that remains lodged inside the spike. The plug blocks flow between the drug vial and adaptor, preventing flow between the adaptor and drug vial. In this plugged state, the adaptor interconnects the drug vial and solution container in a “ready-to-mix” assembly, but the drug and diluent are intended to remain separated. 
     When the drug solution is needed, the adaptor is designed in principle to be “activated”. To activate the adaptor, the user squeezes the solution container, which creates fluid back pressure against the plug in the vial spike. This back pressure expels the plug from the vial spike into the vial, opening the passage between the adaptor and drug vial. The opened passage between the adaptor and drug vial allows diluent to enter the drug vial and mix with the drug to create a drug solution that flows back into the solution container. 
     Adaptors can simplify the preparation of drug solutions but have drawbacks that limit their effectiveness. As an initial concern, the correct use of adaptors is not intuitive for all users. For example, some users may incorrectly assume that connecting an adaptor between a drug vial and solution container will immediately establish an open fluid passage that allows mixing of the drug with diluent. This can discourage users from pre-assembling the adaptor with the drug vial and solution bag ahead of time, out of fear that premature mixing will take place. 
     Other users may be unsure of how to activate the adaptor. This can result in users mishandling the solution bag, drug vial and/or anchor, resulting in accidental leakage or release of the drug or diluent from the system. 
     Another drawback is the absence of an indicator that informs the user whether the adaptor is activated. This can make users uncertain about whether the passage between the drug vial and solution container is open or closed. Such uncertainty can lead to doubt and concern about whether seepage or mixing has taken place during storage. Any mixture created during storage can expire and become unsafe for use. Therefore, if there is any doubt about activation, the user must discard the system. 
     Still another drawback is the possibility of accidental activation of the adaptor. Lack of care in handling and storing the assembled system can subject the system to compression loading, vibration, shock or other condition that causes the plug to dislodge from the vial spike. If the plug dislodges from the vial spike, and there is no seal between the connector and solution container, then the passage between the adaptor and drug vial will open, allowing mixing to take place. 
     Still another drawback is a lack of safety features that inform users that an adapter has been tampered with or used for a previous drug reconstitution. Adaptors should only be used once and then discarded. Unfortunately, it is possible to disconnect adaptors from solution containers after activation and restock them for reuse. Reuse of an adaptor can create a serious risk of infection or cross-contamination with a drug that was previously reconstituted with the adaptor. 
     The foregoing drawbacks illustrate the need for improved adaptors that are safer, more intuitive to use, and less prone to accidental or undesired mixing of drugs and diluents. 
     SUMMARY 
     The drawbacks of conventional adaptors are resolved in many respects with binary connectors in accordance with the present disclosure. 
     In one aspect of the disclosure, a connector can be configured for fluidly connecting a drug container with a solution container in a closed state, and for combining contents of the drug container and the solution container in an activated state. 
     In another aspect of the disclosure, the connector can include a connector body having a first coupling for fluid connection with the drug container. The first coupling can define a first fluid passage. 
     In another aspect of the disclosure, the connector can include a second coupling for fluid connection with the solution container. The second coupling can define a second fluid passage. 
     In another aspect of the disclosure, the connector can have a control valve with a movable valve body. The valve body can define a third fluid passage. 
     In another aspect of the disclosure, the valve body can be positionable relative to the connector body in a first position, in which the first fluid passage is sealed from the second fluid passage to place the connector in the closed state. 
     In another aspect of the disclosure, the valve body can be positionable relative to the connector body in a second position, in which the first fluid passage is connected in fluid communication with the second fluid passage by the third fluid passage to place the connector in the activated state. 
     In another aspect of the disclosure, the first fluid passage can extend parallel to the second fluid passage. 
     In another aspect of the disclosure, the first coupling can include a first piercing member having a first hollow body defining the first fluid passage. 
     In another aspect of the disclosure, the second coupling can include a second piercing member having a second hollow body defining the second fluid passage. 
     In another aspect of the disclosure, the valve body can include a shaft extending into the connector body, the shaft being rotatable relative to the connector body on a control axis. 
     In another aspect of the disclosure, the third fluid passage can extend through the shaft transversely to the control axis. 
     In another aspect of the disclosure, the third fluid passage can define a first opening on a first side of the shaft and a second opening on a second side of the shaft. 
     In another aspect of the disclosure, the first opening can be diametrically opposite the second opening on the shaft. 
     In another aspect of the disclosure, the shaft can be cylindrical and include a cylindrical shaft surface. 
     In another aspect of the disclosure, the control valve can include a seal body that surrounds the shaft surface. 
     In another aspect of the disclosure, the seal body can define a seal body passage having a passage wall that slidingly engages the shaft surface. 
     In another aspect of the disclosure, the seal body passage can include a first passage end, a second passage end, and an inner diameter that varies between the first passage end and second passage end. 
     In another aspect of the disclosure, the seal body passage can form one or more sections of reduced diameter configured to engage, wipe and form one or more seals with the cylindrical shaft surface. 
     In another aspect of the disclosure, the passage wall can include at least one annular seal that forms a seal interface between the seal body and the shaft. 
     In another aspect of the disclosure, the seal body can define a first aperture that forms a first conduit between the seal body passage and the first flow passage, and a second aperture that forms a second conduit between the seal body passage and the second flow passage. 
     In another aspect of the disclosure, the first conduit and second conduit can be axially aligned with one another and located on opposite sides of the seal body passage. 
     In another aspect of the disclosure, the third fluid passage can be aligned with the first conduit and the second conduit when the connector is in the activated state. 
     In another aspect of the disclosure, the third fluid passage can be rotated out of alignment with at least one of the first conduit and the second conduit when the connector is in the closed state. 
     In another aspect of the disclosure, the seal body can include an exterior surface having at least one sealing rib around the first aperture and at least one sealing rib around the second aperture. 
     In another aspect of the disclosure, the control valve can include a control handle attached to the shaft. 
     In another aspect of the disclosure, the control handle can be rotatable relative to the connector body to rotate the shaft about the control axis. 
     In another aspect of the disclosure, the control handle can be rotated to a first orientation in which the valve body is in the first position to place the connector in the closed state. 
     In another aspect of the disclosure, the control handle can be rotated to a second orientation in which the valve body is in the second position to place the connector in the activated state. 
     In another aspect of the disclosure, the control handle can include a lock that prevents rotation of the valve body from the second position to the first position. 
     In another aspect of the disclosure, the lock can include a first locking element on the control handle and a second locking element on the connector body. 
     In another aspect of the disclosure, the first locking element can be configured to engage the second locking element when the control handle is rotated to the second orientation. 
     In another aspect of the disclosure, the first locking element can include at least one ratchet tooth, and the second locking element can include a ledge. 
     In another aspect of the disclosure, the control handle can include a first rotation limiter and the connector body can include a second rotation limiter. 
     In another aspect of the disclosure, the first rotation limiter can be configured to abut the second rotation limiter when the control handle is rotated to the second orientation to prevent the control handle from rotating past the second orientation. 
     In another aspect of the disclosure, the first coupling can include a plurality of flexible tabs arranged in a circular arrangement around the first fluid passage. 
     In another aspect of the disclosure, the plurality of flexible tabs can define a first socket sized to receive the drug container. 
     In another aspect of the disclosure, the first coupling can include an adapter ring detachably connected to the first socket. 
     In another aspect of the disclosure, the adapter ring can be sized to receive an alternate drug container having a different configuration than the drug container. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWING FIGURES 
       The foregoing summary and the following detailed description will be better understood in conjunction with non-limiting examples shown in the drawing figures, of which: 
         FIG.  1    is a front cross sectional view of a connector according to one example of the present disclosure, the connector shown attached to a drug vial and solution container in a first operative state; 
         FIG.  2    is another front cross sectional view of the connector of  FIG.  1   , shown in a second operative state; 
         FIG.  3 A  is a front view of the connector of  FIG.  1   , with a section broken away to show interior elements of the connector in the first operative state; 
         FIG.  3 B  is a front view of the connector of  FIG.  1   , with a section broken away to show interior elements of the connector in the second operative state; 
         FIG.  4    is an exploded perspective view of the connector of  FIG.  1    with additional accessories; 
         FIG.  5    is an enlarged perspective view of a valve body of the connector of  FIG.  1   ; 
         FIG.  6    is another enlarged perspective view of the valve body of the connector of  FIG.  1   ; 
         FIG.  7    is an enlarged perspective view of a seal body of the connector of  FIG.  1   ; 
         FIG.  8    is a first cross sectional view of the seal body of the connector of  FIG.  1   ; 
         FIG.  9    is a second cross sectional view of the seal body of the connector of  FIG.  1   ; 
         FIG.  10 A  is a truncated perspective view of the connector of  FIG.  1   , with a dial rotated to a first position; 
         FIG.  10 B  is a truncated perspective view of the connector of  FIG.  1   , with the dial rotated to a second position; 
         FIG.  10 C  is a truncated perspective view of the connector of  FIG.  1   , with the dial rotated to a third position; 
         FIG.  11 A  is front cross sectional view of the connector of  FIG.  1   , with the valve body positioned in a first position; 
         FIG.  11 B  is a side cross sectional view of the connector of  FIG.  1   , with the valve body positioned in the first position; 
         FIG.  12 A  is front cross sectional view of the connector of  FIG.  1   , with the valve body positioned in a second position; 
         FIG.  12 B  is a side cross sectional view of the connector of  FIG.  1   , with the valve body positioned in the second position; 
         FIG.  13 A  is front cross sectional view of the connector of  FIG.  1   , with the valve body positioned in a third position; 
         FIG.  13 B  is a side cross sectional view of the connector of  FIG.  1   , with the valve body positioned in the third position; and 
         FIG.  14    is a diagram illustrating a method of operating the connector of  FIG.  1    according to the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     Referring to the drawing figures generally, and  FIGS.  1  and  2    in particular, a connector  100  for connecting a drug vial  50  with a solution container  60  is shown according to one example. Connector  100  has a connector body  101  with a first coupling  110  and a second coupling  120 . First coupling  110  is connected to drug vial  50 , which contains a drug  51 . Second coupling  120  is connected to solution container  60 , which contains a diluent  61 . In this arrangement, connector  100  connects drug vial  50  and solution container  60  to create an assembly or set  20  for reconstituting drug  51 . 
     Set  20  provides a convenient way to store drug vial  50  and solution container  60  in a pre-connected, “ready-to-mix” assembly. Drug vial  50  and solution container  60  are not stored in a fluidly connected state, however. Instead, drug vial  50  and solution container  60  are stored in a sealed off arrangement, in which connector  100  prevents drug  51  from combining with diluent  61 , and vice versa. This sealed off arrangement is established independent of any plug that may or may not be created in either coupling. Fluid communication between drug vial  50  and solution container  60  is established only when a user activates the connector  100  to allow mixing to take place. Once connector  100  is activated, various indicators on the device inform the user that the connector is activated. Connector  100  remains locked in the activated state after activation, preventing the connector from being reused. 
       FIG.  1    provides a cross sectional view of connector  100 , and partial cross section views of drug vial  50  and solution container  60 . Connector  100  is shown in a “closed state”, in which the connector interconnects drug vial  50  and solution container  60  in a sealed arrangement that prevents drug  51  from mixing with diluent  61 . The transfer of fluid between drug vial  50  and solution container  60  is prevented by a control valve  130 , which is shown in a closed condition. 
       FIG.  2    provides another cross sectional view of connector  100 , and partial cross sectional views of drug vial  50  and solution container  60 . Connector  100  is shown in the activated state, in which the connector interconnects drug vial  50  and solution container  60  in an unsealed arrangement that permits drug  51  to mix with diluent  61 . The transfer of fluid between drug vial  50  and solution container  60  is permitted by control valve  130 , which is shown in an open condition. 
     Couplings according to the present disclosure can include fluid passages in various shapes and configurations that allow mixing of drugs with diluents. Each fluid passage can be made up of a single straight segment, a single curved segment, multiple straight segments, multiple curved segments, or a combination of straight and curved segments. In addition, each fluid passage can have a uniform cross section along its entire length, or one or more changes in cross section. 
     In the present example, with reference to  FIGS.  11 A,  12 A and  13 A , first coupling  110  has a first outer wall  110   a  that defines a first fluid passage  111  and a pair of first chamber walls  104   a . First fluid passage  111  has a single linear segment and a uniform cross section along its length. Likewise, second coupling  120  has a second outer wall  120   a  that defines a second fluid passage  121  and a pair of second chamber walls  104   b . Second fluid passage has a single linear segment and a uniform cross section along its length. First and second fluid passages  111 ,  121  are axially aligned to one another. The linear and uniform profiles of first and second fluid  5  passages  111 ,  121  provide minimal transitions to allow transfer of fluid smoothly through connector  100 . 
     Control valve  130  includes a valve body  132  defining a third fluid passage  131 . Third fluid passage  131  extends through valve body  132 , and can be aligned with first fluid passage  111  and second fluid passage  121  to allow fluid to flow between drug vial  50  and solution container  60 . The orientation of third fluid passage  131  relative to first and second flow passages  111 ,  121  is dictated by the orientation of valve body  132  relative to connector body  101 . 
     Valve body  132  is positionable relative to connector body  101  in a first position, shown in  FIG.  1   . In this position, third fluid passage  131  is not aligned with first and second fluid passages  111 ,  121 . First fluid passage  111  is sealed from second fluid passage  121  by a number of sealed interfaces, as will be explained. Thus, connector  100  physically connects drug vial  50  and solution bag  60 , but does not provide fluid communication between them. 
     Valve body  132  is movable from the first position to the second position, shown in  FIG.  2   . In this position, third fluid passage  131  is axially aligned with first and second fluid passages  111 ,  121 . Therefore, third fluid passage  131  fluidly connects first fluid passage  111  with second fluid passage  121 , and vice versa. As such, connector  100  physically connects drug vial  50  and solution bag  60 , and provides fluid communication between them. 
     Connectors according to the present disclosure can feature any suitable coupling that allows the connector body to establish a fluid connection with fluid containers. Suitable couplings can include but are not limited to various types of needles, cannulas, spikes, and other tubular or non-tubular connectors that pierce or plug into an access port, stopper or other access point on a fluid container. Suitable couplings can also include various types of port structures, stoppers or other access points configured to receive needles, cannulas, spikes, and other tubular or non-tubular connectors that pierce or plug into them. Piercing connectors according to the present disclosure can have a coring configuration to remove a plug from a stopper or septum that remains in the connector to temporarily block flow through the fluid passage. Alternatively, couplings according to the present disclosure can utilize non-coring connectors. Thus, connectors according to the present disclosure do not require plugs to control activation. 
     Referring to  FIGS.  3 A,  3 B,  11 A and  11 B , first coupling  110  includes a first piercing member in the form of a vial spike  112 . Vial spike  112  has a first hollow body  114  that defines the first fluid passage  111 . First hollow body  114  also has a pointed tip  115  and defines a longitudinal slot  116  on one side. First coupling  110  further includes four flexible tabs  113  that surround vial spike  112 . Tabs  113  collectively form a socket  118  configured to receive the neck portion of drug vial  50 , as shown in  FIGS.  1  and  2   . Tabs  113  firmly latch around drug vial  50  to limit lateral movement of the drug vial after it is connected to first coupling  110 . 
     Connectors according to the present disclosure can be configured to attach to vials of a certain type. For example, the connectors can have sockets designed to only accommodate vials of a selected size. These connectors can include adaptors that allow the connectors to attach to vials that do not have the selected size. In the present example, socket  118  is configured to attach to a 20 mm vial. An optional adaptor  190 , shown in  FIG.  4   , can be inserted into socket  118  to allow connector  100  to attach to a 13 mm vial. Adaptor  190  has a plurality of flexible tabs  191  forming a socket  192  that is a smaller version of socket  118  and sized proportional to a 13 mm vial. Additional adaptors having other sizes can be provided with connector  100  that allow the connector to attach to vials of other sizes. 
     Referring again to  FIGS.  3 A,  3 B,  11 A and  11 B , second coupling  120  includes a second piercing member in the form of a cannula  122 . Cannula  122  has a second hollow body  124  that defines the second fluid passage  121 . Second hollow body  124  also has a pointed tip  125 . A pair of flanges  123  extend beyond cannula  122 , forming a saddle-shaped receiver  127  that partially surrounds the cannula. Receiver  127  is configured to slide over the sides of solution container  60 , receive a port on the solution container, and allow the port on the solution container to connect with cannula  122  in a secure arrangement. 
     Referring now to  FIGS.  4 - 6 ,  11 A and  11 B , valve body  132  features a cylindrical shaft  134  that extends into connector body  101 . Shaft  134  has a first end  134   a  that extends through one side of connector body  101  and a second end  134   b  that extends through the opposite side of the connector body. Shaft  134  is rotatable relative to connector body  101  on a control axis  136 . Third fluid passage  131  extends through the shaft perpendicularly to control axis  136 , as shown in  FIG.  11 B . Third fluid passage  131  also defines a first opening  133  on a first side  135  of the shaft, and a second opening  137  on a second side  139  opposite the first side of the shaft. Shaft  134  includes a cylindrical shaft surface  138  that forms one part of a seal interface, as will be explained. 
     Control valve  130  includes a seal body  140  that cooperates with valve body  132  to control the flow of fluid through connector  100 . Seal body  140  defines a passage  142  having a passage wall  144 . Passages and passage walls according to the present disclosure can have various cross sectional geometries for sealingly engaging the seal body, including but not limited to regular polygonal, irregular polygonal, elliptical, oval and circular. In the present example, passage  142  has a circular cross section so as to form a cylindrical passage. 
     Referring to  FIGS.  7 - 9   , passage  142  has a first passage end  142   a  and a second passage end  142   b  opposite the first passage end. Passage  142  also defines an inner diameter that varies between first passage end  142   a  and second passage end  142   b . The inner diameter varies to form sections of reduced diameter that are configured to engage, wipe and form seals with shaft surface  138 , as will be explained. Shaft surface  138  slidingly engages passage wall  144  while maintaining a sealed interface with the passage wall. In this arrangement, seal body  140  surrounds shaft surface  138  and forms a seal interface between the seal body and shaft surface during movement of valve body  132 . 
     Seal body  140  defines a first aperture  151  and a first conduit  152 . First aperture  151  and first conduit  152  extend between cylindrical passage  142  and first flow passage  111 , as seen in  FIG.  11 A . Seal body  140  also defines a second aperture  153  and a second conduit  154 . Second aperture  153  and second conduit  154  extend between cylindrical passage  142  and second flow passage  121 , as seen in  FIG.  11 A . First conduit  152  includes a first tapered section  155  that expands radially outwardly and widens toward first aperture  151 . Second conduit  154  includes a second tapered section  156  that expands radially outwardly and widens toward second aperture  153 . First conduit  152  and second conduit  154  are axially aligned with one another and extend transversely to cylindrical passage  142 . 
     Referring to  FIGS.  11 A- 13 B , shaft  134  is rotatable relative to seal body  140  and connector body  101  during operation of control valve  130 . Shaft  134  can be rotated ninety degrees between a first shaft position and second shaft position. In the first shaft position, third fluid passage  131  extends perpendicular to, and out of alignment with, first and second conduits  152 ,  154  and first and second flow passages  111 ,  121 . This position, shown in  FIG.  11 A , places connector  100  in the closed state. In the second shaft position, third fluid passage  131  is parallel to and axially aligned with first and second conduits  152 ,  154  and first and second flow passages  111 ,  121 . This position, shown in  FIG.  13 A , places connector  100  in the activated state. First flow passage  111 , first conduit  152 , third flow passage  131 , second conduit  154  and second flow passage  121  align end to end to create a singular and continuous linear flow passage through connector  100  when the connector is in the activated state. Seal body  140  is positioned in connector body  101  so that first conduit  152  is always axially aligned with first flow passage  111 , and second conduit  154  is always axially aligned with second flow passage  121 . 
     Connectors according to the present disclosure can feature one or more seal interfaces. The seal interface(s) prevent fluid flow between a drug vial and solution container when the connector is in the closed state. In addition, the seal interface(s) prevent unwanted flow of fluid within the connector when the connector is in either the closed state or activated state. For example, one or more seal interfaces can be provided between the valve body and seal body to limit or prevent seepage of fluid in spaces between the valve body and seal body. In addition, or in the alternative, one or more seal interfaces can be provided between the seal body and connector body to limit or prevent seepage of fluid in spaces between the seal body and connector body. 
     Referring back to  FIGS.  7 - 9   , seal body  140  has four substantially planar sides  140   a ,  140   b ,  140   c ,  140   d . Seal body  140  also has two tapered sides  140   e ,  140   f  arranged on opposite sides of the seal body. Each tapered side  140   e ,  140   f  tapers outwardly and away from cylindrical passage  142 , forming a V-shaped face. The V-shaped face of tapered side  140   e  forms a vertex along a midline  140   g , and the V-shaped face of tapered side  140   f  forms a vertex along a midline  140   h  parallel to midline  140   g . In this configuration, seal body  140  has a generally hexagonal cross section conforming to two trapezoids that intersect, as shown in  FIG.  8   . This hexagonal cross sectional shape aids the insertion of seal body  140  into connector body  101 , as will be explained. The hexagonal cross sectional shape also distributes compression loading more uniformly around shaft  134 . 
     Referring to  FIGS.  12 A- 13 B , second coupling  120  is directly connected to first coupling  110  such that first outer wall  110   a  and second outer wall  120   a  form a first chamber  101   c  inside the first and second couplings. In addition, the pair of first chamber walls  104   a  and the pair of second chamber walls  104   b  form a second chamber  103  inside the first and second couplings that houses seal body  140 . Chamber  103  has an internal geometry that conforms to the outer geometry of seal body  140 . In particular, first chamber walls  104   a  and second chamber walls  104   b  have a V-shaped geometry conforming to tapered sides  140   e ,  140   f . Seal body  140  is made of a resilient seal material such as silicone. The outer diameter of shaft surface  138  is slightly greater than the inner diameter of cylindrical passage  142 . In this arrangement, insertion of shaft  134  into cylindrical passage  142  during assembly pushes the walls of seal body  140  outwardly, expanding the seal body. This outer expansion causes seal body  140  to bear against first chamber walls  104   a  and second chamber walls  104   b  in chamber  103 , creating an outer seal around the seal body. 
     Referring again to  FIGS.  7 - 9   , seal body  140  also forms outer seals around areas of chamber  103  that intersect with first and second flow passages  111 ,  121 . In particular, planar sides  140   a ,  140   c  of seal body  140  each include a pair of concentric ring shaped seals  149 . Ring shaped seals  149  surround first and second apertures  151 ,  153 , respectively. Each ring shaped seal  149  forms an outward protrusion or rib that contacts connector body  101 . In this arrangement, ring shaped seals  149  entrap fluid that seeps from the flow passages into areas between seal body  140  and connector body  101 , preventing that fluid from migrating beyond the ring shaped seals. 
     Seal body  140  further defines inner seals between passage wall  144  and shaft  134 . Some of the inner seals are arranged in a central portion  143  of cylindrical passage  142  that surrounds the third flow passage  131 , as shown in  FIG.  9   . Other inner seals are arranged in cylindrical passage  142  outside of central portion  143 . 
     The inner seals include eight circumferential seals  146  on passage wall  144  in central portion  143 . Each circumferential seal  146  is a short, linear, inwardly extending protrusion or rib that extends parallel to control axis  136  and contacts shaft surface  138  in a sealing engagement. In this arrangement, circumferential seals  146  entrap fluid that seeps from first conduit  152  and/or second conduit  154  into the space between shaft surface  138  and passage wall  144 , preventing further flow of that fluid in a circumferential direction relative to control axis  136 . 
     The inner seals also include six axial seals  148  on passage wall  144  outside of central portion  143 . Three axial seals  148  are positioned on one side of third flow passage  131 , and the other three axial seals are positioned on the opposite side of the third flow passage. Each axial seal  148  is a ring-shaped, annular, inwardly extending protrusion or rib that circumscribes control axis  136  and contacts shaft surface  138  in a sealing engagement. In this arrangement, axial seals  148  entrap fluid that seeps between shaft surface  138  and passage wall  144  and prevents further flow of that fluid in an axial direction parallel to control axis  136 . 
     Seals according to the present disclosure can have different cross sectional shapes. Two options include trapezoidal shaped seals and rounded seals. Trapezoidal seals generally provide a better seal than rounded seals because they provide greater deflection with less compressive force to create the required pressure differential between seals. However, rounded seals undergo less damage than trapezoidal seals in instances where the seals rub against adjacent surfaces during assembly. This resistance to damage can outweigh the superior sealing properties of trapezoidal seals if the stresses on the seals are significant. Therefore, the specific shape of a seal can be selected based on factors such as its location and the stresses it is subjected to during assembly. 
     In the present example, ring shaped seals  149  are trapezoidal in cross section, as seen in  FIGS.  8  and  9   . This shape provides more deflection of the seal with less compressive force to create the required pressure differential between the seals. Circumferential seals  146  and axial seals  148  have oval or elliptical shaped cross sections. These shapes are more rounded to allow insertion of shaft  134  into cylindrical passage  142  without causing damage to the seals. The oval or elliptical shapes of circumferential seals  146  and axial seals  148  also provide the largest possible sealing surfaces against shaft  134 . 
     Control valves according to the present disclosure are the mechanisms used to activate the connector. Once the connector is activated, the drug vial and solution container are connected in fluid communication, allowing mixing to take place. Connectors according to the present disclosure can include mechanisms to prevent accidental activation so as to avoid pre-mature mixing before the medication is needed. In addition, connectors according to the present disclosure can include mechanisms that inform users about the operative condition of the connector, i.e. whether the connector is closed or activated. Moreover, connectors according to the present disclosure can include mechanisms that allow users operating the control valve to know when they have successfully activated the connector. Finally, connectors according to the present disclosure can include mechanisms that prevent the connectors from being used more than once. 
     In the present example, connector  100  integrates the foregoing mechanisms into valve body  132  generally, and more specifically, into a control handle  160  as shown  FIGS.  4 - 6   . Control handle  160 , which is part of valve body  132 , includes a circular dial  162  attached to first end  134   a  of shaft  134 . Dial  162  extends in a plane perpendicular to control axis  136 , and is centered on the control axis such that the center of the dial lies on the control axis. A first side  164  of dial faces away from connector body  101 , and a second side  166  of the dial faces toward connector body. A finger rest  168  projects outwardly from first side  164  and is configured to allow a user to rotate the dial using their fingers and/or thumbs in a twisting motion. Dial  162  can be rotated to rotate shaft  134  between the first and second shaft positions, thus moving the connector from the closed state to the activated state. 
     Control handles according to the present disclosure can have different configurations, and need not have circular dials. For example, control handles can also feature a polygonal shaped dial, a T-handle, a knurled knob, or other suitable structure for rotating the shaft. 
     Shaft  134  is inserted through two openings  102  in the walls of connector body  101 . In this position, shaft  134  is rotatable about control axis  136  but has limited ability to translate along control axis. Axial translation of shaft  134  through connector body  101  is limited by dial  162  on one side of the connector body and a pair of tapered flanges  180  on the opposite side of the connector body. Flanges  180  are configured to converge radially inwardly as second end  134   b  is inserted through each of the openings  102  in the wall of connector body  101 , and subsequently expand. Once expanded, flanges  180  are larger than openings  102 , preventing shaft  134  from being reversed out of connector body  101 . This axial fixation of shaft  134  is shown in  FIGS.  10 A- 13 B . 
     Referring to  FIGS.  3 A- 4  and  6   , control handle  160  and connector body  101  feature rotation limiters that control how far dial  162  and shaft  134  can be rotated relative to the connector body. Control handle  160  has a first rotation limiter in the form of two stop pegs, pins or tabs  161 . One tab  161  is visible through the partial break in  FIG.  3 A , with the other tab being diametrically opposed and shown in  FIG.  6   . Connector body  101  has a second rotation limiter in the form of two arc-shaped tracks  105 . Each track  105  has a first end wall  106 , a second end wall  107 , and an arc-shaped pathway  108  extending between the first and second end walls. Each tab  161  is positioned in one of the tracks  105  and movable within its arc-shaped pathway  108  as dial  162  is rotated relative to connector body  101 . First and second end walls  106 ,  107  provide stops that prevent tab  161  from moving beyond the end walls. 
     When looking at first side  164  of dial  162  in  FIG.  3 A , the relative positions of tabs  161  in tracks  105  can be described in terms of numbers on a clock face. The counterclockwise direction is represented by the arrow CCW. For brevity, the relative position of the visible tab  161  will be described, with the understanding that the position of the other tab is offset by 6 hours on the clock face (i.e. 180 degrees) and moves in the same manner. 
     The visible tab  161  in  FIG.  3 A  is shown abutting first end wall  106  in the 6 o&#39;clock position. In this position, shaft  134  is oriented in the first shaft position which places the connector in the closed state. The same tab  161  is shown in  FIG.  3 B  abutting second end wall  107  after the tab is rotated counterclockwise ninety degrees to the 3 o&#39;clock position. In this position, shaft  134  is oriented in the second shaft position which places the connector in the activated state. Thus, each tab  161  is movable in its respective track  105  through a range of 90 degrees to move shaft  134  from the first shaft position to the second shaft position. Consequently, dial  162  can be rotated counterclockwise ninety degrees, starting from the first orientation shown in  FIG.  3 A , and ending in the second orientation shown in  FIG.  3 B , in order to switch connector  100  from the closed state to the activated state. To maintain the connector in the activated state, second end wall  107  stops tab  161  at the 3 o&#39;clock position to prevent counterclockwise rotation of shaft  134  past the second shaft position. 
     Connector  100  has a one-way lock  170 , which is shown engaged in  FIG.  10 B . The term “one-way lock”, as used herein, refers to a mechanism that prevents relative movement of an object in one direction after the mechanism is engaged, but allows relative movement of the object in the opposite direction. In the present example, one-way lock  170  allows shaft  134  to rotate in the counterclockwise direction toward the second shaft position, but prevents the shaft from being rotated back toward the first shaft position after dial  162  is rotated counterclockwise past a certain point. This prevents connector  100  from being restored to the closed state after connector  100  is activated. 
     One-way lock  170  cooperates with other features of connector  100  to eventually form a two-way lock  175 . The term “two-way lock”, as used herein, refers to a mechanism that prevents relative movement of an object in one direction after the mechanism is engaged, as well as relative movement of the object in the opposite direction. Two-way lock  175 , which is shown engaged in  FIGS.  3 B and  10 C , is configured to retain connector  100  in the activated state after activation to prevent the connector from being reused. 
     Referring to  FIGS.  6  and  10 A , one-way lock  170  includes two pairs of ratchet teeth or ramps arranged around second side  166  of dial  162 . One-way lock  170  also includes two ledges  109  on the exterior of connector body  101  that engage the ramps. Each pair of ramps includes a first ramp  171  and a second ramp  172 . First and second ramps  171 ,  172  project from second side  166  of dial  162  and are configured to engage ledges  109  on the exterior of connector body  101 . One of the ledges  109  is shown in  FIG.  10 A . Each ledge  109  extends toward second side  166  of dial  162  in a position to positively engage first and second ramps  171 ,  172  when the dial is rotated. Each of ramps  171 ,  172  has a leading edge  173  and a trailing edge  174 . Each leading edge  173  has a sloped surface, with the slope defined by an acute angle between the sloped surface and second side  166  of dial. Each trailing edge  174  extends normal to second side  166 . First and second ramps  171 ,  172  are arranged on dial  162  so that their leading edges  173  are the first edges to engage ledge  109  during counterclockwise rotation. 
     Connectors according to the present disclosure can include removable caps that cover the first and second couplings. The removable caps can be configured to enclose the vial spike and cannula and protect them from contaminants. The removable caps can also allow users to hold the connector without placing their fingers near the vial spike and cannula, reducing the risk of injury from contact with the vial spike and cannula. Furthermore, the removable caps allow users to keep the vial spike and cannula covered, and delay exposing them until the moment before they are attached to drug vials and solution containers. Thus reduces the risk of the vial spike and cannula becoming contaminated before use. 
     Referring to  FIG.  4   , connector  100  includes a first cap  117  that is attachable over and removable from vial spike  112 . Connector  100  also includes a second cap  119  that is attachable over and removable from second coupling  120 . First and second caps  117 ,  119  can attach to vial spike  112  and second coupling  120 , respectively, by any suitable mechanism, such as mating surfaces on the exterior of the connector and interior of the cap that releasably engage. Suitable examples include but are not limited to tabs, detents, threading and other connections. 
     Referring to  FIG.  11 A , connector  100  can be assembled in the following manner. Connector body  101  is made up of two separate halves, a first half  101   a  that includes first coupling  110 , and a second half  101   b  that includes second coupling  120 . First cap  117  is connected over vial spike  112  on first half  101   a , and second cap  119  is connected over second coupling  120  on second half  101   b . Seal body  140  is inserted into first half  101   a , in an area that constitutes one part of chamber  103 . The tapered shape of seal body  140  and first chamber walls  104   a  aid in properly orienting and seating the seal body into first half  101   a . Once the seal body  140  is seated in first half  101   a , second half  101   b  is connected to the first half over the seal body. This applies compression force around seal body  140 . 
     Once connector body  101  is assembled, valve body  132  can be connected to the connector body. This is done by inserting second shaft end  134   b  of shaft  134  through openings  102  of connector body  101  and through cylindrical passage  142  of seal body  140 . Inserting shaft  134  through connector body  101  after the first and second halves  101   a ,  101   b  are connected provides more flexibility and latitude to obtain the required forces and/or ultrasonic energy required to create a robust, functional and secure assembly. 
     Once shaft  134  advances through both sides of connector body  101 , flanges  180  snap outwardly. Dial  162  and flanges  180  engage opposite sides of connector body  101  to lock the axial position of shaft  134  in the connector body. Insertion of shaft  134  through seal body  140  expands the seal body, thereby compressing the exterior of the seal body against first chamber walls  104   a  and second chamber walls  104   b  of chamber  103  to form a tight seal around the seal body. 
     A method of using a connector according to the present disclosure will now be described with reference to steps illustrated in  FIG.  14    and using connector  100  as an example. 
     Connector  100  is removed from any packaging and inspected prior to use (step  1000 ). In particular, connector should be inspected to confirm that the connector is in the closed state. If connector  100  is not in the closed state, the connector should not be used. The operative state of the connector is indicated by the relative orientation of dial  162 . The relative orientation of dial  162  can be determined by observing the orientation of finger rest  168  relative to vial spike  112  and cannula  122 . Finger rest  168  should be oriented horizontally when cannula  122  is pointed upwardly, as shown in  FIG.  3 A . In this position, shaft  134  is oriented in the first shaft position so that third fluid passage  131  is perpendicular to, and therefore out of fluid communication with, first and second flow passages  111 ,  121 . This condition is shown in  FIGS.  11 A and  11 B . First and second flow passages  111 ,  121  are sealed off from one another by seal body  140 , preventing any transfer of fluid from solution container  60  to drug vial  50 , and vice versa. 
     Once the closed state is confirmed, connector  100  is connected to drug vial  50  (step  1100 ). Drug vial  50  is prepared for use according to the manufacturer&#39;s instructions. For example, if drug vial  50  has a protective cap over the stopper, the cap can be removed and the stopper can be disinfected using institutional protocol. Drug vial  50  is then placed on a hard flat surface in an upright position with the stopper facing up. 
     First cap  117  is carefully removed from connector  100  to expose vial spike  112 . Second cap  119  remains attached over cannula  122 . Connector  100  is held above drug vial  50  with vial spike  112  facing downwardly and aligned with the drug vial&#39;s stopper. Connector  100  is then lowered over drug vial  50 , with one hand holding the drug vial stable on the flat surface, and the other hand gripping second cap  119 . Connector  100  is lowered until the top of drug vial  50  enters socket  118 , and tip  115  contacts the stopper. Referring to  FIG.  4   , second cap  119  includes a cylindrical handle portion  119   a  with surface splines  119   b  that make the second cap easier to grip during this process. Second cap  119  also has a flat end  119   c  that provides a place for the user to rest their palm. 
     Using their palm, the user presses straight down on flat end  119   c  of second cap  119  to push connector  100  onto drug vial  50 . Connector  100  is pressed down firmly until vial spike  112  penetrates through the stopper and tip  115  enters the inside of drug vial  50 . At this stage, drug vial  50  is held firmly between tabs  113 , with the tabs preventing lateral movement of the drug vial. 
     With drug vial  50  now attached, connector  100  is connected to solution container  60  (step  1200 ). Second cap  119  is removed from second coupling  120  to expose cannula  122 . A large flange  119   d  is provided on second cap  119  that allows the user to apply twisting or pulling force to remove the second cap from second coupling  120 . Solution container  60  can be prepared for connection to cannula  122  according to instructions provided by the container&#39;s manufacturer. For example, if solution container  60  has a protective cap over the port, the cap is removed. The port is then disinfected using the appropriate protocol. 
     Solution container  60  is grasped in one hand, and connector  100  is held in the other hand with second coupling  120  facing the port on the solution container. Connector  100  can be held by grasping connector body  101  and/or the bottom of drug vial  50 , the latter of which is exposed outside of the connector as shown in  FIG.  1   . Connector  100  is then advanced toward solution container  60 , or vice versa, until the port on the solution container begins to enter receiver  127 . Connector  100  is also rotated until flanges  123  are oriented relative to solution container  60  so they can slide over the sides of the solution container. Once flanges  123  are properly oriented, connector  100  is pushed onto solution container  60  until tip  125  of cannula  122  penetrates the port and enters the interior of the solution container. Care should be taken not to squeeze or apply compression force to solution container  60  at any time during assembly. 
     Drug vial  50 , solution container  60 , and connector  100  are now attached to one another for form set  20 . Set  20  can be stored according to institutional protocol in a ready-to-mix condition, with the contents of vial  50  and solution container  60  sealed from one another. Control valve  130  remains closed during storage and transport to keep diluent  61  from contacting drug  51 , even if set  20  is subjected to compression, vibration, shock or other form of agitation. 
     When the medication is needed, set  20  can be removed from storage and inspected prior to use (step  1300 ). Connector  100  should be visually inspected to confirm that the connector has remained in the closed state during storage. As noted above, the operative state of the connector is confirmed by observing the orientation of dial  162  and finger rest  168 , the latter of which should appear in the horizontal orientation shown in  FIG.  3 A . 
     In addition to inspecting connector  100 , drug vial  50  and solution container  60  should be visually inspected to identify any evidence of leakage of drug  51  and/or diluent  61 , and/or mixing of the drug with diluent. If there is any evidence of leakage or mixing, set  20  should be discarded. If no concerns are found, the medication can be prepared. 
     To mix the contents of drug vial  50  and solution container  60 , the user activates connector  100  (step  1400 ). From the vantage point represented in  FIG.  3 A , connector  100  is activated by rotating dial  162  in the counterclockwise direction. Connector  100  has multiple features that indicate the correct direction of rotation in the event that the user forgets or is unsure of which direction to turn the dial. First, dial  162  includes visual indicia  167  on first side  164  of dial  162 , as shown in  FIG.  5   . Indicia  167  consists of a written instruction and arrows indicating that the dial should be rotated counterclockwise to activate connector  100 . 
     Connector  100  also provides tactile feedback that informs the user of the correct direction of rotation. Tactile feedback is provided by the initial engagement between tabs  161  and first end walls  106  in tracks  105 . First end walls  106  abut tabs  161  to prevent the tabs from moving in a clockwise direction with respect to FIG.  3 A. This creates physical resistance to clockwise rotation, which the user feels through their fingers when attempting to rotate dial  162  clockwise from the closed position. 
     As the user rotates dial  162  counterclockwise, tabs  161  begin moving in a counterclockwise direction along tracks  105 . Shaft  134  also begins rotating counterclockwise relative to seal body  140 . In particular, shaft  134  rotates out of the first shaft position and toward the second shaft position. This gradually rotates third fluid passage  131  into alignment with first and second fluid passages  111 ,  121 . Dial  162  is rotated counterclockwise until first ramps  171  contact their corresponding ledges  109 . As each first ramp  171  contacts its respective ledge  109 , the user can detect a slight resistance to further rotation in their fingers. This resistance is caused by interference between ledges  109  and the sloped surfaces of leading edges  173 .  FIG.  10 A  shows dial  162  rotated counterclockwise with one of the ledges  109  interfering with one of the first ramps  171 . The other first ramp  171  and ledge  109  are also engaged in the same manner on the opposite side of dial  162 . In this state, dial  162  is deflected outwardly under stored energy in response to contact between first ramps  171  and ledges  109 . 
     Dial  162  is rotated counterclockwise until the trailing edges  174  of first ramps  171  pass ledges  109 . When the trailing edges  174  rotate past ledges  109 , dial  162  reaches an intermediate position, indicating that connector  100  is partially activated. The term “partially activated”, as used herein, refers to an operative state between the closed state and the activated state. First and second flow passages  111 ,  121  are still sealed from one another by seal body  140  to prevent transfer of fluid from drug vial  50  to solution container  60 , and vice versa. However, third fluid passage  131  is rotated closer to alignment with first flow passage  111  and second flow passage  121 . The partially activated state is shown in  FIGS.  12 A and  12 B . 
     When dial  162  reaches the intermediate position, ledges  109  no longer interfere with first ramps  171 . Therefore, the forces causing deflection of dial  162  are removed, allowing the stored energy in the dial to release and return the dial to its relaxed state. Dial  162  snaps back to its relaxed form, creating an audible click that the user hears. In addition, the user detects the disengagement of first ramps  171  from ledges  109  through tactile feel, as the resistance to counterclockwise rotation felt through finger rest  168  drops substantially. As such, the user feels greater and greater resistance to counterclockwise rotation as dial  162  approaches the intermediate position, followed by a sudden drop in resistance when the dial reaches the intermediate position. Finger rest  168  is oriented at an acute angle relative to its original horizontal orientation. This change in appearance of finger rest  168  allows the user to infer their progress as they rotate dial  162  toward the activated condition. 
     Each ledge  109  creates an obstruction in the path of each trailing edge  174  after dial  162  reaches the intermediate position. Each trailing edge  174  extends normal to second side  166 , as noted above, such that it will abut its respective ledge  109  if the user attempts to rotate dial  162  clockwise from the intermediate position. As such, first ramps  171  and ledges  109  form a one-way lock  170 , as mentioned earlier. One-way lock  170  prevents rotation of dial  162  clockwise from the intermediate position, while allowing continued counterclockwise rotation of the dial from the intermediate position. The abutment between one of the trailing edges  174  and its corresponding ledge  109  is shown in  FIG.  10 B . 
     Dial  162  is rotated counterclockwise from the intermediate position until second ramps  172  engage ledges  109 . Second ramps  172  are configured to engage and pass ledges  109  in the same manner as first ramps  171 . That is, dial  162  deflects to a stored energy condition and snaps back to a relaxed condition in the same or similar manner as when first ramps  171  engage and pass ledges  109 . When the trailing edges  174  of second ramps  172  pass ledges  109 , dial  162  has reached a final position, shown in  FIG.  3 B . In this state, shaft  134  is oriented in the second shaft position shown in  FIGS.  13 A and  13 B , which places connector  100  in the activated state. 
     The activated state is signaled to the user in a manner similar to the partially activated state. Dial  162  snaps back to its relaxed form, creating an audible click that the user hears. In addition, the user can detect the disengagement of second ramps  171  from ledges  109  through tactile feel as dial  162  snaps back to its relaxed form. However, the user also notices that dial  162  has little or no ability to rotate in either the clockwise or counterclockwise direction relative to connector body  101 . Clockwise rotation is limited by ledges  109 , which obstruct the paths of second ramps  172  to limit or prevent clockwise rotation of dial  162 . The obstruction created by one of the ledges  109  in the path of one of the second ramps  172  is shown in  FIG.  10 C . 
     Further rotation of dial  162  in the counterclockwise direction is also prevented by the abutment between tabs  161  and second end walls  107  of tracks  105 . This abutment, shown in  FIG.  3 B , prevents shaft  134  from rotating past the second shaft position, which would rotate third flow passage  131  past its aligned orientation with first and second flow passages  111 ,  121 . In this arrangement, second ramps  172 , ledges  109 , tabs  161  and second end walls  107  form the two-way lock  175  mentioned earlier. Two-way lock  175 , which is represented in  FIGS.  3 B and  10 C , prevents dial  162  from rotating in either direction after it reaches its final position. Therefore, rotation of dial  162  from the intermediate position to the final position passively locks connector  100  in the activated state (step  1500 ). 
     Once connector  100  is activated and locked in the activated state, the user can prepare the medication by mixing the contents of drug vial  50  and solution container  60  through the connector (step  1600 ). This may include steps such as folding and/or squeezing solution container  60  to cause diluent  61  to flow through connector  100  into drug vial  50  to mix with drug  51  and return to the solution container. 
     The foregoing steps do not apply exclusively to connector  100 , and can be performed with other connectors according to the present disclosure. 
     Although this description makes reference to specific embodiments and illustrations, the present disclosure is not intended to be limited to the details shown. Rather, the present disclosure encompasses various modifications and combinations of embodiments and features described herein, as well as other variations that may be made within the scope and range of the claims and equivalents. 
     For example, in another exemplary embodiment, the connector could be activated by rotating the dial in a clockwise direction relative to  FIG.  3 A , rather than counterclockwise. In addition, the dial can feature more ramps on the dial to provide one-way locks at two or more intermediate positions. As an alternative, the dial can have only one ramp on each half of the dial, so that the dial is only lockable in the final position corresponding to the activated state. In such an arrangement, the dial would only be locked via a two-way lock. 
     Connectors according to the present disclosure can also connect containers at various angles other than the angle shown in  FIGS.  1  and  2   . For example, it may be desirable in some applications to connect a first fluid container with a second fluid container at a slight angle so that one of the containers is raised or tilted. In such an application, a connector may feature a first coupling and a second coupling angularly offset from the first coupling by an obtuse angle, for example 150 degrees, so that the second flow passage is offset from the first flow passage by 150 degrees. In another application, the connector can have first and second flow passages oriented in an L-shape, i.e. offset 90 degrees from one another. The third flow passage through seal body could be bent or curved at one or more sections to accommodate any angular offset between containers and any change in flow direction between the first and second flow passages. 
     Accordingly, it is intended that the appended claims cover all such variations as fall within the scope of the present disclosure.