Reconstitution device

A reconstitution device for storing a first component of a pharmaceutical preparation includes a receptacle, a cap having a first end secured to the receptacle, a second end, and an inner bore having a central aperture. The device further includes a stopper located between the receptacle and the cap, the stopper including a portion capable of being perforated. The device also includes a plunger secured to the second end of the cap, a locking mechanism located in the cap, and an actuating mechanism. The actuating mechanism may prevent the device from inadvertent activation.

FIELD OF THE INVENTION

The present application relates generally to reconstitution devices. More particularly, the application relates to an improved reconstitution device for connecting a closed receptacle and a container, such as a syringe.

DESCRIPTION OF RELATED ART

In the domain of drug-packaging, it is known to store a component of a medicinal preparation, such as for example its active ingredient, in a recipient closed by a stopper of relatively non-rigid material, for example of elastomer. A liquid may be introduced into this recipient after perforation of the stopper in order to dissolve the component contained in the recipient or place it in suspension, with a view to obtaining a medicinal preparation in liquid form ready to be administered to the patient.

Traditional devices include a base adapted to cover the neck of the recipient and extending in a flange forming an inner bore while a plunger is adapted to slide in the bore, between a position disengaged with respect to the stopper and an engaged position in which a hollow needle borne by the plunger traverses this stopper. The displacement of the plunger from its disengaged position towards its engaged position is effected manually by an operator.

However, traditional devices do not include an actuating mechanism to prevent unwanted use of the device and to facilitate user interaction. Since the reconstitution device is not meant to be reused, unwanted actuation of the device could be wasteful and incur unnecessary costs. Furthermore, traditional devices do not prevent the device from being reused.

Accordingly, it is desirable to develop a reconstitution device that facilitates user interaction by increasing the likelihood that the user follows the proper steps in the reconstitution process, as well as sufficiently preventing the device from being inadvertently actuated or reused.

SUMMARY

The present invention is directed to a reconstitution device. In accordance with an exemplary embodiment of the invention, the reconstitution device includes: (i) a receptacle, (ii) a cap including a first end secured to the receptacle, a second end, and an inner bore having a central aperture, (iii) a stopper located between the receptacle and the cap, the stopper including a portion capable of being perforated, (iv) a plunger secured to the second end of the cap, (v) a locking mechanism located in the cap, and (vi) an actuating mechanism.

In accordance with another exemplary embodiment of the invention, the reconstitution device comprises: (i) a receptacle having an opening surrounded by a neck, (ii) a cap including a first end, a second end, and an inner bore having an aperture, the first end being secured to the receptacle, (iii) a stopper located within the opening of the neck, the stopper including a portion capable of being perforated, (iv) a plunger secured to the second end of the cap and being adapted to slide along the inner bore of the cap, the plunger having a shaft, (v) a locking mechanism located between the cap and the stopper for engagement with the shaft of the plunger, and (vi) an actuating mechanism located on the plunger and the cap, wherein when the actuating mechanism is activated, the plunger travels downwardly through the locking mechanism to perforate the stopper.

In accordance with yet another exemplary embodiment of the invention, the reconstitution device comprises: (i) a receptacle, (ii) a cap including a first end, a second end, and an inner bore having a central aperture, the first end being secured to the receptacle, (iii)a stopper located between the receptacle and the cap, the stopper including a portion capable of being perforated, (iv) a plunger secured to the second end of the cap, the plunger including a shaft for perforating the stopper, (v) a locking mechanism located on the plunger comprising a thin material including a tongue capable of flexing in a vertical direction and an aperture that is coaxially aligned with the shaft of the plunger, and (vi) a feedback mechanism for indicating to a user when the plunger has perforated the stopper.

The present invention helps to solve the shortcomings of the prior art by facilitating user interaction by increasing the likelihood that the user follows the proper steps in the reconstitution process. The device further provides an improved means of tamper-proofing than currently available reconstitution devices.

These as well as other aspects and advantages will become apparent to those of ordinary skill in the art by reading the following detailed description, with reference where appropriate to the accompanying drawings. Further, it should be understood that the embodiments described in this summary and elsewhere are intended to illustrate the invention by way of example only.

DETAILED DESCRIPTION

FIG. 1depicts a reconstitution device10. The device10may include a receptacle12for storing a first component of a pharmaceutical preparation (not shown), such as its active ingredient, for example. The receptacle12may include an opening16surrounded or partially surrounded by a neck14. The neck14may also include a lip15. The opening16in the neck14allows for a second component (not shown), such as a liquid, to be introduced into the receptacle12and mix with the first component. A stopper18may be positioned in the opening16of the neck14to block access to the receptacle12. The stopper18may be made of a relatively non-rigid material, such as elastomer. The stopper18may include a top portion20located against the lip15, and a bottom portion22located within the opening of the neck14. The top portion20may be capable of being perforated, thereby allowing access to the receptacle12.

The device10may further include a cap24secured to the neck14of the receptacle12. The cap24may have a first end26, which is secured to the neck14of the receptacle12, and a second end28located opposite the first end26. The first end26of the cap24may surround at least a portion of the stopper18. The first end26of the cap24may include one or more flexible legs30so the cap24can expand to fit over the lip15of the neck14during the manufacturing process, and then contract to securely mate with the neck14. The cap24may further include a step portion32located between the first end26and the second end28, thereby separating the first end26from the second end28. The first end26of the cap24may have a larger diameter than the second end28of the cap24.

The first end26of the cap24may be secured to the receptacle12by a C-clip34, which may be positioned in an indentation25in the first end26of the cap24. Therefore, the C-clip34is not located directly on the neck14of the receptacle12and no scratching occurs. The C-clip34may be made of a material not subject to heat degradation, such as metal for example, so that the device10may be resistant to heat tampering.

The first end26of the cap may be surrounded by a sleeve36for protection. The sleeve36is prevented from sliding off the cap24by the step portion32. The sleeve36may include a wave-shaped part37to facilitate opening by a user (not shown), as can be seen in detail inFIG. 6. The sleeve36may further include a textured surface to facilitate gripping of the device10by a user.

Assembly of the first end26of the cap24to the receptacle12may be carried out using various methods. For example, an assembly method may include initially inserting the C-clip34into the indentation25, and then sliding the cap24over the stopper18and the lip15. As another example, an assembly method may include initially placing the C-clip34onto the second end28of the cap24, then sliding the sleeve36over the second end28in such a way that the sleeve36contacts the C-clip34and pushes the C-clip34into the indentation25, and then sliding the cap24over the stopper18and the lip15. In accordance with these exemplary methods, as the cap24is slid over the stopper18and the lip15, the opening in the C-clip34allows the flexible legs30to expand as the flexible legs30pass over the lip15, and the flexible legs30may contract after passing over the lip15to secure the cap to the receptacle12.

FIG. 2depicts details of a plunger38located at the second end28of the cap24. The cap24may also include a ridge35, shown inFIG. 3, which may be used to secure the plunger38within the cap24. The plunger38may comprise a first portion39. The first portion39of the plunger38may include a top surface41. The top surface41may be arranged in various configurations. For example, the top surface41may be dome-shaped (i.e., a domed top surface). As another example, the top surface41may be angled (i.e., an angled top surface). Other exemplary configurations of the top surface41are also possible.

The first portion39of the plunger38may further include a shaft42extending downwardly in a direction towards the stopper18. The shaft42may include a pointed end44for piercing the top portion20of the stopper18, thereby allowing the shaft42access to the receptacle12. The pointed end44may be angled to cooperate with a locking mechanism64, which is described in detail below.

In one embodiment, the shaft42is elliptical-shaped (e.g., oval shaped). The shaft42being elliptical-shaped requires less applied force when the shaft42pierces the stopper18. In alternative embodiments, the shaft42may have a cylindrical shape or a rectangular shape.

The plunger38may comprise a second portion40which is located below the first portion39. The second portion40of the plunger38preferably has the same shape as the first portion39, (e.g., an elliptical shape, a cylindrical shape, or a rectangular shape).

In one exemplary embodiment, the first portion39of the plunger38is permanently attached to the second portion40of the plunger38so as to prevent leaks (e.g., a fluid leak) between where the first portion39mates to the second portion40. Various methods may be used to permanently attach the first portion39of the plunger38to the second portion40of the plunger38. For example, the first portion39of the plunger38may be permanently attached to the second portion40of the plunger38by ultrasonic welding. As another example, the first portion39of the plunger38may be permanently attached to the second portion40of the plunger38by use of an adhesive (e.g., a glue). Other exemplary methods for permanently attaching the first portion39of the plunger38to the second portion40of the plunger38are also possible.

The plunger38may further include one or more filtering mechanisms. For example, a fluid filter45may be located in the first portion39of the plunger so as to filter any liquid that is introduced into the plunger38. Furthermore, an air filter46may be located in a cavity49(shown inFIG. 3) between the first portion39of the plunger38and the second portion40of the plunger38so as to filter any air that is introduced into the receptacle12. The air filter46may be made from any of a variety of materials, but is preferably made of polyethersulphone (PES). Both filters may be located in line with the shaft42of the plunger38.

The first portion39of the plunger38may include a male element48extending from the top surface41in an upward direction opposite the shaft42. The male element48may be configured to receive a second receptacle90, such as a syringe, for example, as shown inFIGS. 8A and 8B. The male element48may include an inner bore50and an outer surface51. The outer surface51may include a thread52for mating with the second receptacle90.

An advantage of the dome or angled shape of the top surface41is that the male element48visibly extends above the top surface41. When the male element48receives the second receptacle90(e.g., by fastening a threaded syringe to the thread52of the male element48), a user can clearly see when the second receptacle90is not in contact with the top surface41. In this way, a user fastening the second receptacle90can continue to turn the second receptacle90and clearly tell when the second receptacle90makes contact with the top surface41. Thus, the user knows when second receptacle90is fully secured to the male element48.

Referring toFIG. 3, the shaft42of the plunger38may include a first longitudinal channel54. The first longitudinal channel54establishes communication between the receptacle12and the inner bore50of the male element48. The first channel54may allow fluid to pass through the shaft42of the plunger38and into the receptacle12.

The shaft42of the plunger38may include a second longitudinal channel56. The end of the second channel56located opposite the pointed end44of the shaft42may interface to an air channel return53. The air channel return53interfaces to a cavity49. The cavity49is formed by joining the first portion39of the plunger38to the second portion40of the plunger38. The second channel56functions as an air path to allow air to travel out of the receptacle12through the shaft42of the plunger38, into the air channel return53, through the filter46, and then through the vent47located on the top surface41of the plunger38. The air exiting the vent47is vented to the atmosphere surrounding the device10.

The cap24may further include an inner bore58having an annular plate60with an aperture62. The aperture62is coaxially aligned with the shaft42of the plunger38. The plunger38may be configured to slide along the inner bore58of the cap24, or alternatively, the plunger38may be configured to slide along an outer surface of the cap, as shown inFIG. 9, which will be described below. When the plunger38is pushed downward toward the receptacle12, the shaft42moves downwardly through the aperture62to pierce the top portion20of the stopper18.

The device10may include a locking mechanism64for preventing upward movement of the plunger38after downward movement of the plunger38has occurred. In this manner, the device10may be prevented from multiple uses by restraining the plunger38in an engaged position, that is, when the shaft42pierces the stopper18.

The locking mechanism64may use St. Venant's principle, which states deformations due to stress concentrations are not observed at a distance of three major diameters from the stress concentration. In accordance with this principle, if the locking mechanism64is made of a thin material that deforms an area of the shaft42greater than the thickness of the thin material as the shaft42is moved in a downward direction, then the locking mechanism64will prevent the shaft42from moving in an upward direction because the locking mechanism will fall in the deformed area of the shaft42.

As shown inFIG. 4, the locking mechanism64may include a thin, cylindrically shaped material. Alternatively, the locking mechanism64could be another shape such as elliptical or rectangular. The locking mechanism64may be made of any flexible material, such as metal or plastic, for example.

The locking mechanism64may be located at various locations within the device10. For example, as shown inFIG. 3, the locking mechanism64may be located below the annular plate60. As another example, the locking mechanism64may be located above the annular plate60. As yet another example, the locking mechanism64could be incorporated into the cap24(e.g., the locking mechanism could be made of the same material as the cap24and molded to the cap24).

The locking mechanism64may include a tongue66extending therefrom, and being located within a first aperture67of the locking mechanism64. The tongue66may be connected to the first aperture67at tab69, and therefore the tongue66is capable of flexing in the vertical direction. The tongue66may include a second aperture68that is coaxially aligned with the shaft42. The diameter of the second aperture68may be slightly larger than the diameter of the shaft42. The tongue66may be bent upward, as shown inFIG. 4.

In operation, the locking mechanism64functions as a unidirectional cam. When the plunger38is pushed downwardly, the shaft42presses the tongue66downwardly, thereby opening the second aperture68enough to allow the shaft42to pass through the second aperture68and pierce the stopper18. The locking mechanism64is triggered when a user attempts to pull the plunger38upwardly after the plunger38has been pushed downwardly.

When the plunger38is pulled upwardly, the shaft42pulls upwardly on the tongue66which causes the tongue66to flex vertically in an upward direction. The flexing causes the second aperture68to change shape from a first shape (e.g., a cylindrical shape when the second aperture68is substantially perpendicular to the shaft42) to a second shape (e.g., an elliptical shape when the second aperture68is in a position not perpendicular to the shaft42). In this way, the shape of the second aperture68may be different from the shape of the shaft42. Since the shaft42cannot freely pass through the second aperture68due in part to their different shapes, the tongue66then cuts into the shaft42, creating a stress concentration, or notch (not shown), in the shaft42. The second aperture68in the tongue66fits into the notch and prevents the plunger38from upward movement. Therefore, the plunger38may not be removed from the stopper18, or moved in an upward direction, without damaging the device10.

The locking mechanism64ensures a smooth downward motion of the plunger38with low actuation force and prevents reuse of the device10by retaining the plunger38in a downward position due to a high retaining force (relative to the actuation force). The locking mechanism64may prevent return motion at any point during the downward movement of the shaft42. Thus, the locking mechanism64improves upon retaining clips used in other reconstitution devices to secure a plunger only after the plunger has reached the most downward point of the plunger's downward travel.

The device10may include an actuating mechanism. The actuating mechanism may include at least one indentation70located on an outer circumference of the plunger38, on both the first portion39and the second portion40, and at least one protrusion72located on the inner bore58of the cap24, on the second end28of the cap24. The indentation70located on the second portion40may include a passage71and a groove73.

When the device10is in a disengaged position, the at least one indentation70and the at least one protrusion72are not aligned and the plunger38is prevented from downward movement. Thus, the actuating mechanism acts as a safety from accidentally pushing down on the plunger38and piercing the stopper18. An upper end75of the at least one protrusion72may be rounded so that the upper end75of the at least one protrusion72rests in the groove73when the device10is in the disengaged position.

In order to use the device10, a user may rotate the plunger38a given number of degrees until the at least one indentation70aligns with the at least one protrusion72, as shown inFIGS. 5A and 5B. The top surface41of the plunger38may include direction markers74to indicate to a user which direction to turn the plunger, as best seen inFIG. 6. The top surface41may further include alignment markers76to indicate to the user when the actuating mechanism is aligned.

As the user rotates the plunger38, the at least one protrusion72also moves downward so that the at least one protrusion72can move from the groove73to the passage71and then move from the passage71to the at least one indentation70. The movement from the passage71to the at least one indentation70can provide tactile feedback and/or audible feedback to the user so that the user knows when the plunger38has been rotated the given number of degrees and it is acceptable to push the plunger38in a downward direction.

The given number of degrees the plunger38is rotated to align the at least one indentation70with the at least one protrusion72depends on various factors. For example, the factors may include: (i) the number of indentations of the at least one indentation70and the number of protrusions of the at least one protrusion72, (ii) the spacing between each protrusion (if more than one protrusion is used), and the spacing between each indentation (if more than one indentation is used), (iii) the position of the at least one indentation70relative to the position of the at least one protrusion72at the time the device10is assembled and/or at the time the plunger38is to be rotated, and (iv) the size of the at least one indentation70and the size of the at least one protrusion72(e.g., each protrusion and indentation may be 1/36th(i.e., 10 degrees) of the circumference of the inner bore58of the cap24and the outer circumference of the plunger38, respectively).

In one exemplary embodiment, the at least one protrusion72includes three protrusions substantially equally spaced around the inner bore58of the cap (e.g., substantially spaced one hundred twenty degrees apart), and the at least one indentation70includes three indentations substantially equally spaced around the outer circumference of the plunger38(e.g., substantially spaced one hundred twenty degrees apart). In accordance with this exemplary embodiment, the given number of degrees the plunger38is rotated to align the at least one indentation70with the at least one protrusion72is preferably is about thirty (30) degrees. However, depending on one or more of the factors described above, the given number of degrees may be substantially between five (5) degrees and one hundred twenty (120) degrees.

Referring toFIG. 5C, the plunger38may then be pushed downwardly into the engaged position so the shaft42may pass through the aperture62in the cap24and pierce the stopper18. Once the shaft42has pierced the stopper18, the locking mechanism64prevents the plunger38from being pulled back upwardly to the disengaged position.

The device10may include a feedback mechanism that provides a user of the device10with feedback regarding operation of the device10. For example, the feedback may indicate that the shaft42has traveled an optimum distance into the stopper18. Alternatively, or in combination, the feedback may indicate that the plunger38has traveled an optimum distance within the cap24and that the user should not push the plunger38any further. Other examples of the feedback provided by the feedback mechanism are also possible.

The feedback mechanism may be arranged in various configurations. For example, as shown inFIGS. 2 and 3, the feedback mechanism may comprise (i) a convex bump55located on the surface of the second portion40of the plunger38and extending into the indentation70, and (ii) a convex bump57on the protrusion72.

The convex bump55may be molded as part of the second portion40. The convex bump55may extend 0.2 mm to 1.0 mm (preferably 0.3 mm to 0.6 mm) away from the second portion40. A widest portion of the convex bump55may have a diameter between 0.2 mm to 1.0 mm (preferably 0.3 mm to 0.6 mm).

The convex bump57may be molded as part of the indentation70. The convex bump57may extend 0.2 mm to 1.0 mm (preferably 0.3 mm to 0.6 mm) away from the indentation70. A widest portion of the convex bump57may have a diameter between 0.2 mm to 1.0 mm (preferably 0.3 mm to 0.6 mm).

In operation, and by way of example, as the plunger38travels in a direction towards the stopper18, the feedback mechanism provides tactile feedback as the convex bump55on the indentation70travels past the convex bump57on the protrusion72. The tactile feedback may be felt by the user. Moreover, as the convex bump55on the indentation70travels past the convex bump57on the protrusion72, a sound may be made such that the feedback mechanism also provides audible feedback.

With reference toFIG. 7, the device10may include a top80which is positioned over the second end28of the cap24and the plunger38. The top80protects the plunger38. The top80may further include a textured surface82for facilitating gripping and removal of the top80by a user. Additionally, a tamper-proof mechanism84may be located on the device10to indicate to a user whether the device10has been used. The tamper-proof mechanism84may comprise any type of indicator, such as a seal, a holographic label, or a tab, for example.

In operation, the device10is in the disengaged position, that is, when the protrusions72of the cap24and the indentations70of the plunger38are not aligned, and the shaft42of the plunger38is not piercing the stopper18, as shown inFIG. 8A. Once the top80is removed from the device10by a user, the tamper-proof mechanism84will be broken. A user may then attach a second receptacle90, such as a syringe, to the receptacle12. To activate the device10, a user may then rotate the plunger38about the given number of degrees (e.g., 30 degrees) so the indentations70on the plunger38align with the protrusions72on the cap24. The plunger38may then be pushed in a downward direction toward the stopper18into the engaged position, as shown inFIG. 8B. The shaft42of the plunger38may pierce the stopper18, allowing access to the opening16of the receptacle12. The contents of the second receptacle90may then be introduced into the receptacle12to mix with the component. The mixed contents may then be pulled back into the second receptacle90. A needle (not shown) may then be secured to the second receptacle90, and the complete and active drug may be administered to a patient.

Referring toFIG. 9, a second embodiment110of the reconstitution device of the present invention is shown. The device110may include a receptacle112for storing a first component of a pharmaceutical preparation (not shown), such as its active ingredient, for example. The receptacle112may include an opening116surrounded or partially surrounded by a neck114. The neck114may also include a lip115. The opening116in the neck114allows for a second component, such as a liquid (not shown), to be introduced into the receptacle112and mix with the first component. A stopper118may be positioned in the opening116of the neck114to block access to the receptacle112. The stopper118may be made of a relatively non-rigid material, such as elastomer. The stopper118may include a top portion120located against the lip115, and a bottom portion122located within the opening116of the neck114. The top portion120may be capable of being perforated, to allow access to the receptacle112.

The device110may further include a cap124secured to the neck114of the receptacle112. The cap124may have a first end126, which is secured to the neck114of the receptacle112, and a second end128located opposite the first end126. The first end126of the cap124may surround at least a portion of the stopper118. The first end126of the cap124may include a protrusion130for securing the first end126to the lip115of the receptacle112.

The first end126of the cap124may further be secured to the receptacle112by a crimp ring132, which may be positioned in an indentation125in the first end126of the cap124. The crimp ring132may extend completely or around only a portion of the circumference of the first end126of the cap124. The crimp ring132may be made of metal or a polymer with low creep sensitivity. The crimp ring132may further include an upper surface134for attaching to a top180, which will be described below.

The device110may include a plunger138located at the second end128of the cap124. The plunger138may include a shaft142extending in a direction towards the stopper118. The shaft142may include a pointed end144for piercing the top portion120of the stopper118, thereby allowing the shaft142access to the receptacle112. The shaft142may further include a filtering mechanism (not shown) similar in structure and function to the filtering mechanism disclosed above with respect to device10.

The plunger138may also include a male element148extending in a direction opposite the shaft142. The male element148may be configured to receive a second receptacle (not shown), such as a syringe, for example. The male element148may include an inner bore150and an outer surface151. The outer surface151may include a thread152for mating with the second receptacle.

The shaft142of the plunger138may also include first and second longitudinal channels (not shown) which establish communication between the receptacle112and the inner bore150of the male element148. The longitudinal channels are similar in structure and function to the longitudinal channels described above with respect to device10. The plunger138may further be configured to slide along the outer circumference of the cap124, as shown inFIG. 9.

The cap124may further include an inner bore158having an annular plate160with an aperture162. The aperture162is coaxially aligned with the shaft142of the plunger138. When the plunger138moves downward toward the receptacle112, the shaft142moves downwardly through the aperture162to pierce the top portion120of the stopper118.

The device110may include a mechanism that prevents upward movement of the plunger138after downward movement of the plunger138towards the stopper118has occurred. As an example, the device110may include a locking mechanism such as the locking mechanism64described above. The locking mechanism may be used to retain the plunger138to the device110.

As another example, the device110may include a ratcheting mechanism that prevents upward movement of the plunger138after downward movement of the plunger138towards the stopper118has occurred. The ratcheting mechanism may be used to retain the plunger to the device110.

The ratcheting mechanism may include one or more series of ribs and one or more series of teeth. Each of the one or more series of ribs corresponds to one of the series of teeth.FIG. 10shows the device110including (i) a series of ribs164located on an outer surface of the cap124, and (ii) a series of teeth166located on an inner surface of the plunger138. The series of ribs164corresponds to another set of teeth (not shown) located on the inner surface of the plunger138. The series of teeth166corresponds to another series of ribs (not shown) located on the outer surface of the cap124.

In this way, as the plunger138is moved in a downward direction towards the stopper118, one or more teeth of a series of teeth (not shown) travel over the series of ribs164, whereas if upward movement of the plunger138is attempted, one or more teeth of the series of teeth (not shown) encounter the series of ribs164so as to prevent the one or more teeth as well as the plunger138from moving upwards. Similarly, as the plunger138is moved in a downward direction towards the stopper118, one or more teeth of a series of teeth166travel over a series of ribs (not shown), whereas if upward movement of the plunger138is attempted, one or more teeth of the series of teeth166encounter the series of ribs (not shown) so as to prevent the series of teeth166as well as the plunger138from moving upwards.

The cap124and plunger138of the device110may further include an actuating mechanism similar in structure and function to the actuating mechanism described above with respect to the device10.

The device110may include a top180, as shown inFIG. 11, which fits over the second end128of the cap124and the plunger138, and attaches to the crimp ring132. The top180protects the device110.

Moreover, the top180and the crimp ring132may be formed as a single piece (i.e., a top and crimp ring combination (not shown)). To accommodate the top and crimp ring combination, the cap124may have a first end and a second end, and the first end may be larger in diameter than the second end (similar to the first end26of the cap24and the second end28of the cap24shown inFIG. 1). In this way, the top and crimp ring combination may slide over the plunger138so as to allow the cap124to be secured to the receptacle112. To use the device110with the top and crimp ring combination, the top may be broken off (e.g., by twisting the top) and the crimp ring continues to secure the cap124to the receptacle112.

Additionally, a tamper-proof mechanism (not shown) may be located on the device110to indicate to a user whether the device has been used. The tamper-proof mechanism may comprise any type of indicator, such as a seal, a holographic label, or a tab, for example.

In operation, the device110is in a disengaged position, that is, the shaft142of the plunger138is not piercing the stopper. Once the top180is removed from the device110, the tamper-proof mechanism will be broken. A user may then attach a second receptacle, such as a syringe, to the receptacle112. The plunger138may then be pushed in a downward direction toward the stopper118into an engaged position. The shaft142of the plunger138may pierce the stopper118, allowing access to the opening116of the receptacle112. The contents of the second receptacle may then be introduced into the receptacle112to mix with the component. The mixed contents may then be pulled back into the second receptacle. A needle (not shown) may then be secured to the second receptacle, and the complete and active drug may be administered to a patient.

While certain features and embodiments of the present invention have been described in detail herein, it is to be understood that the invention encompasses all modifications and enhancements within the scope and spirit of the following claims.