Method and system of customizing dispensing of pharmaceuticals

A closure system includes a non-child resistant cap configured to screw on and off a container in a non-child resistant mode. The system further includes a child resistant element configured to be able to be assembled with the non-child resistant cap to convert the non-child resistant cap to a child resistant cap permitting a push-down-and-turn action to remove the child resistant cap from a container. A child proof element is separate from the child resistant element is configured to be able to be assembled with the non-child resistant cap to convert the non-child resistant cap to a child proof cap requiring a key to remove the child proof cap from a container.

FIELD

This disclosure relates to a pharmaceutical closure system. More particularly, this disclosure relates to a pharmaceutical closure system that provides different modes of operation of increasing difficulty in removing the closure system from a container.

BACKGROUND

Many pharmaceutical container closure systems, and particularly prescription container closure systems, often include a “child resistant” mode of operation, and sometimes both “non-child resistant” and “child resistant” modes. While these types of closure systems are generally very effective in preventing a child from opening the closure in the child resistant configuration, it is not impossible for children to open them (hence the name “child resistant”). In particular, a child playing with this type of closure system may sometimes be drawn to certain locking/unlocking features, such as a push-down tab, visible on the cap resulting in the child unintentionally removing the cap from its container. Also, particularly in the case of push-down-and-turn child resistant closures, the child may even figure out how to remove the closure by simply watching their parents, or even reading instructions displayed on exterior of the closure, and then being able to do so on their own. Accordingly, what is needed, at least as an option for consumers that have young children in their household, is a “child proof” closure system.

While many “lock-and-key” type closure systems are disclosed in the prior art in an attempt to provide an effective “child proof” closure system, no such systems have been commercialized, at least on any significant scale. This is likely due to weakness of the designs that have been introduced so far, including designs that would not be effective in actually preventing children from being able to open the containers and designs having flaws that would make the closure systems expensive to manufacture and/or impractical from a commercial standpoint.

For example, U.S. Pat. No. 6,032,811 provides a cap assembly having an outer cap member and an inner cap member each having a key slot. While the outer cap is designed to rotate independently of the inner cap, a key may be inserted into the key slots to turn the inner cap when the key slots are aligned. One of the many problems with this overly simplistic design is that the key actually comes secured to the cap, the slot on the outer surface of the outer cap is clearly visible, and the slot is configured such that ordinary household items could be inserted into the slot. Accordingly, just like children toys that teach toddlers motor skills by inserting different shapes into different slots, certain children playing with the closure could end up inserting the key or other household object into the slots. Once the key is inserted correctly, whether intentionally or not, it is very likely that the child would be able to open the container. The prior art includes many other closure systems that suffer these same deficiencies. In fact, many of the systems are actually designed such that normal household items may be used to open the closure system, such as U.S. Pat. No. 3,396,864 patent, further described below, which includes a slot designed to be used with a coin. What is needed therefore is a more discrete locking system that makes it more difficult for a child to recognize or understand how to open the closure system or otherwise prevents attracting child actions that result in the child unintentionally opening the container.

Similarly, U.S. Pat. No. 3,485,402 provides a cap assembly with two opposing key hole openings in the outer cap operable to be aligned with opposing key holes on the inner cap for engagement with a key having opposed prongs. The openings of the inner and outer cap were not designed to be discreet but to allow the key to traverse the center of the cap that includes a screw to secure the inner cap within the outer cap. This design suffers several critical flaws, most critical of which is that an additional gasket (i.e., additional expense and complexity) is needed to prevent air, moisture, leakage, etc. from coming into or escaping the container opening due to the key holes of the inner cap and the screw that is inserted through the outer and inner caps. Further, the gasket extends into the opening of the container such that, like the '864 patent described below, the '402 patent does not permit induction sealing. Also, due to the key having to traverse, the screw extending from the outer cap, pushing down on the key to insert the key prongs into the key holes with the handle would actually pivot the prongs out of the key holes.

Additionally, like the gasket and screw of the '402 patent, many of the prior art “child proof” closure systems include numerous parts, which adds thickness and cost to manufacturing the cap. For example, U.S. Pat. No. 4,796,768 describes a lockable closure cap that requires a standard type key, springs, cams, etc. to lock the closure to the container. As would be expected, this type of closure, while requiring a specialty key, would be expensive to manufacture. Further, all the various parts required to provide use of a standard key design results in a large and unattractive size for the closure and prevents the closure from being applied to a container in an automated dispensing system.

U.S. Pat. No. 3,396,864 and European Patent No. 06311945 disclose other locking caps having ratchet ramps on both the outer cap and inner cap that allow the closure assembly to be screwed onto a container when the outer cap is rotated in a clockwise direction but is designed to prevent the closure from being removed without a key when the outer cap is rotated in the counter-clockwise direction. While it is desirable in certain instances to be able to provide a closure that can be screwed onto a container but requires key to remove the closure, the '864 patent is silent as to how this would be accomplished other than including ramps on both the inner cap and outer cap. Additionally, like many of the other locking closures of the prior art, including the '811 patent described above, the key slots/indentions of the cap portions are centrally located in the '864 patent and '945 patent. This requires a pocket to be formed that extends into the interior space of the inner caps. The pocket is formed due to the needed depth of the slot of the inner cap that is configured to receive the key and prevents the opening of the closure from being lined in an induction sealing process as known in the art. Further, the pocket results in additional resin being needed to form the cap, adds needless weight to the cap, and slows down the molding/cycle time required to make the closure.

In another aspect, many closure systems, particularly those designed to be child resistant, are difficult to open and close for the elderly as well as those with arthritic hand conditions. Thus, while it would be beneficial to provide a multifunctional key that not only unlocks the closure system but also assists a user in both screwing the closure system on and off a container, the prior art has generally ignored this aspect when designing the interaction between the keys and the closure systems. For example, the '864 patent, '945 patent, and '402 patent described above provide locking closure systems in which the key engages a recess centrally located within the inner cap. Thus, the key is unable to provide much additional torque than what would already be supplied by a user that just rotates the outer cap upon engagement with the inner cap.

Further, likely because the locking closure systems of the prior art did not recognize or otherwise were unable to successfully implement a closure system in which the key provided an appreciable mechanical advantage in screwing the closure system on and off a container, none of these systems describe a closure having both a child resistant option and a key option. Such a system is advantageous in numerous situations. For example, both options may be preferred for elderly patients that have trouble opening and closing child resistant closures but also have caregivers that often dispense their medications. Thus, the elderly individual may desire a tool that assists in screwing the closure on and off a container, while the caregiver may wish to open the container using the normal child resistant function. Also, both options would be beneficial when a child resistant cap is secured to a container in automated dispensing systems. In this regard, workers required to perform spot checks of prescriptions that are dispensed in these automated systems must screw on and off countless child resistant caps, and, thus, often complain of hand pain and carpal tunnel symptoms. Providing these workers with a tool to quickly assist them in screwing on and off these child resistant caps would thus be beneficial. Also, liquid pharmaceuticals often result in the sticky pharmaceutical being spilled onto the driving structures of child resistant caps, making such structures generally ineffective. By providing a closure system in which both a child resistant and key option are available, the key can be utilized if the user has trouble opening the closure due to the driving structures having been exposed to spills of the liquid pharmaceutical.

In view of the above, what is needed therefore is a lockable closure assembly that, while providing a discrete locking system, is efficient to manufacture. Further, a system in which a user has more options of varying degrees of difficulty to open the closure system based on the consumer's particular circumstances, including a key that serves as an effective tool to make the closure system easy to open and close when used, is desired.

SUMMARY

A system and method of customizing the dispensing of a prescription pharmaceutical for a customer in a pharmaceutical container includes providing a quantity of a pharmaceutical closure system. The pharmaceutical closure system includes a non-child resistant cap configured to screw on and off the container in a non-child resistant mode to allow ready removal of the closure system when only the non-child resistant cap is installed on the container; a child resistant element that is separate from the non-child resistant cap and is configured so as to be able to be assembled with the non-child resistant cap to convert the non-child resistant cap to a child resistant cap, wherein the child resistant element when assembled with the non-child resistant cap in a child resistant mode is configured to permit removal of the assembled child resistant cap upon a push-down-and-turn action being applied to the child resistant element when the assembled child resistant cap is installed on the container; and a child proof element that is separate from the child resistant element and the non-child resistant cap and is configured so as to be able to be assembled with the non-child resistant cap to convert the non-child resistant cap to a child proof cap, wherein the child proof element when assembled with the non-child resistant cap in a child proof mode is configured to require a key to remove the assembled child proof cap when the assembled child proof cap is installed on the container. The method further includes determining whether the customer wants the non-child resistant cap, the child resistant cap, or the child proof cap on the container for the prescription of the customer; dispensing the prescription pharmaceutical in the container having only the non-child resistant cap when the customer does not want the child resistant cap or the child proof cap; converting the non-child resistant cap to the child resistant cap by assembling the child resistant element with the non-child resistant cap and dispensing the prescription pharmaceutical in the container having the assembled child resistant cap when the customer wants the child resistant cap; and converting the non-child resistant cap to the child proof cap by assembling the child proof element with the non-child resistant cap and dispensing the prescription pharmaceutical in the container having the assembled child proof cap when the customer wants the child proof cap. A key may also be provided to the customer configured to remove the assembled child proof cap when the customer wants the child proof cap.

According to certain embodiments, the determining and converting steps are performed at the pharmacy. In some embodiments, the method further includes installing the non-child resistant cap on the container before converting the non-child resistant cap to one of the child resistant cap and the child proof cap. In preferred embodiments, the child resistant element is configured so as to be able to be permanently assembled with the non-child resistant cap to permanently convert the non-child resistant cap to a child resistant cap and the child proof element is configured so as to be able to be permanently assembled with the non-child resistant cap to permanently convert the non-child resistant cap to a child proof cap.

According to certain embodiments, the child resistant element when assembled with the non-child resistant cap is configured so that the non-child resistant cap is positionable within the child resistant element to convert the assembled child resistant cap between the child resistant mode and a non-child resistant mode, wherein when the non-child resistant cap is positioned within the child resistant element in the non-child resistant mode the assembled child resistant cap is operable to be screwed on and off the container without a depressive force. Similarly, in certain embodiments, the child proof element when assembled with the non-child resistant cap is configured so that the non-child resistant cap is positionable within the child proof element to convert the assembled child proof cap between the child proof mode and a non-child resistant mode, wherein when the non-child resistant cap is positioned within the child proof element in the non-child resistant mode the assembled child proof cap is operable to be screwed on and off the container without requiring the key.

According to certain embodiments, the child resistant element when assembled with the non-child resistant cap in a child resistant mode is also configured to permit a key to be inserted through a portion of the child resistant element to engage the non-child resistant cap and remove the assembled child resistant cap installed on the container in a child resistant mode by rotation of the key.

According to another embodiment of the disclosure, closure system includes a non-child resistant cap including a plurality of driving structures disposed proximate a periphery of a top surface of the non-child resistant cap; a child resistant element separated from the non-child resistant cap and being configured to be assembled with the non-child resistant cap to convert the non-child resistant cap to a child resistant cap, the child resistant element including a plurality of driving structures disposed proximate the periphery of a top interior surface; a child proof element separated from the non-child resistant cap and being configured to be assembled with the non-child resistant cap to convert the non-child resistant cap to a child proof cap, the child proof element including at least one aperture disposed in a top surface of the child proof element; and a key having at least one projection. The child resistant element when assembled with the non-child resistant cap in a child resistant mode is configured so that the plurality of driving structures of the child resistant element engage the plurality of driving structures of the non-child resistant cap when rotating the child resistant element in a first direction to install the child resistant cap on the container and permit removal of the assembled child resistant cap upon the plurality of driving structures of the child resistant element engaging the plurality of driving structures of the non-child resistant cap when a push-down-and-turn action is applied to the child resistant element in a second direction. The child proof element when assembled with the non-child resistant cap in a child proof mode is configured to require the at least one projection of the key to be inserted through the at least one aperture of the child proof element to engage at least one of the plurality of driving structures of the non-child resistant cap to remove the assembled child proof cap when the child proof cap is installed on the container. In preferred embodiments, the child proof element includes a substantially smooth top interior surface without driving structures disposed thereon to form the child proof cap when assembled with the non-child resistant cap.

According to certain embodiments, the child resistant element further includes at least one aperture disposed in a top surface of the child resistant element, wherein the child resistant element when assembled with the non-child resistant cap in the child resistant mode is also configured to permit the at least one projection of the key to be inserted through the at least one aperture of the child proof element to engage at least one of the plurality of driving structures of the non-child resistant cap to remove the assembled child resistant cap installed on the container in the child resistant mode by rotation of the key.

According to certain embodiments, the child resistant element when assembled with the non-child resistant cap is configured so that the non-child resistant cap is positionable within the child resistant element to convert the assembled child resistant cap between the child resistant mode and a non-child resistant mode, wherein, when the non-child resistant cap is positioned within the child resistant element in the non-child resistant mode, the assembled child resistant cap is operable to be screwed on and off the container without a depressive force. Similarly, the child proof element when assembled with the non-child resistant cap may be configured so that the non-child resistant cap is positionable within the child proof element to convert the assembled child proof cap between the child proof mode and a non-child resistant mode, wherein, when the non-child resistant cap is positioned within the child proof element in the non-child resistant mode, the assembled child proof cap is operable to be screwed on and off the container without requiring the key.

According to certain embodiments, each of the plurality of driving structures of the non-child resistant cap include a recess disposed in the top surface of the non-child resistant cap, the recess including a bottom wall in axial alignment with the top surface and a pair of opposing side walls extending substantially perpendicular from the bottom wall to the top surface. According to this embodiment, each of the plurality of driving structures of the child resistant element preferably include ratchet ramps, the ratchet ramps operable to engage one of the side walls of each of the recesses of the non-child resistant cap when the child resistant element is rotated in the first direction without a depressive force while requiring the depressive force for the ratchet ramps to engage the opposing side walls of the recesses when the child resistant element is rotated in the second direction.

According to another embodiment of the disclosure, a method and system of customizing the dispensing of a prescription pharmaceutical for a customer in a pharmaceutical container includes providing a quantity of a pharmaceutical closure system. The closure system includes a non-child resistant cap configured to screw on and off the container in a non-child resistant mode to allow ready removal of the closure system when only the non-child resistant cap is installed on the container, and a child resistant element that is separate from the non-child resistant cap and is configured so as to be able to be permanently assembled with the non-child resistant cap to convert the non-child resistant cap to a child resistant cap. The child resistant element, when assembled with the non-child resistant cap, is configured so that the non-child resistant cap is positionable within the child resistant element to convert the assembled child resistant cap between a child resistant mode and a non-child resistant mode, the child resistant mode being configured to permit removal of the assembled child resistant cap upon a push-down-and-turn action being applied to the child resistant element when the assembled child resistant cap is installed on the container and the non-child resistant mode being configured so that the assembled child resistant cap is operable to be screwed on and off the container in a non-child resistant mode. The method further includes determining whether the customer wants the non-child resistant cap or the child resistant cap for the prescription of the customer; dispensing the prescription pharmaceutical in the container having only the non-child resistant cap when the customer does not want the child resistant cap; and converting the non-child resistant cap to the child resistant cap by assembling the child resistant element with the non-child resistant cap and dispensing the prescription pharmaceutical in the container having the assembled child resistant cap when the customer wants the child resistant cap.

According to certain embodiments, the method further includes determining whether the customer wants the child resistant cap in the child resistant mode or the non-child resistant mode when the customer wants the child resistant cap; positioning the non-child resistant cap within the child resistant element for the child resistant mode when the customer wants the child resistant cap to be in the child resistant mode; and positioning the non-child resistant cap within the child resistant element for the non-child resistant mode when the customer wants the child resistant cap to be in the non-child resistant mode.

In yet another embodiment, a method and system of customizing the dispensing of a prescription pharmaceutical for a customer in a pharmaceutical container includes providing a quantity of a pharmaceutical closure system. The closure system includes a non-child resistant cap configured to screw on and off the container in a non-child resistant mode to allow ready removal of the closure system when only the non-child resistant cap is installed on the container, and a child proof element that is separate from the non-child resistant cap and is configured so as to be able to be permanently assembled with the non-child resistant cap to convert the non-child resistant cap to a child proof cap. The child proof element, when assembled with the non-child resistant cap, is configured so that the non-child resistant cap is positionable within the child proof element to convert the assembled child proof cap between a child proof mode and a non-child resistant mode, the child proof mode being configured to require a key to remove the assembled child proof cap when the assembled child proof cap is installed on the container and the non-child resistant mode being configured so that the assembled child resistant cap is operable to be screwed on and off the container in a non-child resistant mode. The method further includes determining whether the customer wants the non-child resistant cap or the child proof cap for the prescription of the customer; dispensing the prescription pharmaceutical in the container having only the non-child resistant cap when the customer does not want the child proof cap; and converting the non-child resistant cap to the child proof cap by assembling the child proof element with the non-child resistant cap and dispensing the prescription pharmaceutical in the container having the assembled child proof cap when the customer wants the child proof cap.

According to certain embodiments, the method further includes determining whether the customer wants the child proof cap in the child proof mode or the non-child resistant mode when the customer wants the child proof cap; positioning the non-child resistant cap within the child proof element for the child proof mode when the customer wants the child proof cap to be in the child resistant mode; and positioning the non-child resistant cap within the child proof element for the non-child resistant mode when the customer wants the child proof cap to be in the non-child resistant mode.

According to another aspect of the disclosure, a key for opening a closure system is disclosed having a base surface; a set of projections extending from the base surface in a first direction, the set of projections dimensioned and configured to be inserted through the at least one set of apertures of an outer cap to engage at least one set of driving structures of an inner cap when the at least one set of apertures and at least one set of driving structures of the assembled closure system are vertically aligned. The key is further dimensioned and configured to correspond to the outer cap such that the base surface of the key abuts the top surface of the outer cap when the at least one set of projections of the key are engaged with the at least one set of driving structures of the inner cap. In preferred embodiments, the set of projections are positioned to engage the at least one set of driving structures of the inner cap through at least one set of apertures disposed proximate an outer periphery of the top surface of the outer cap.

According to certain embodiments, the set of projections of the key are disposed proximate the periphery of the base surface. The key may also include a side wall extending from the base surface in the first direction coaxially with the set of projections. According to this embodiment, the key is preferably dimensioned and configured so that the set of projections will align with the at least one set of apertures of the outer cap upon substantially aligning an interior surface of the side wall of the key with an exterior surface of the side wall of the outer cap and rotating the key with respect to the outer cap. The side wall of the key is then operable to slide down the side wall of the outer cap upon the set of projections of the key becoming aligned with the at least one set of apertures of the outer cap and engaging the at least one set of driving structures of the inner cap.

According to preferred embodiments, the base surface of the key is cylindrical and the side wall is a circumferential side wall extending from an outer periphery of the cylindrical base surface to correspond to the top surface and side wall of the outer cap. According to certain embodiments, the key further includes a second set of projections extending from the base surface in a second direction opposite the first direction, the second set of projections positioned on the base surface to correspond to a second outer cap of different dimensions than the first outer cap.

According to yet another embodiment of the disclosure, a key includes a base surface and a side wall extending from at least a portion of the base surface in a first direction. At least one projection extends from the base surface in the first direction coaxially with the side wall, the at least one projection dimensioned and configured to be inserted through the at least one aperture of the outer cap to engage the at least one driving structure of the inner cap when the at least one aperture and at least one driving structure of the assembled closure system are vertically aligned. The key is further dimensioned and configured to correspond to the outer cap such that at least a portion of the base surface of the key abuts the top surface of the outer cap and at least a portion of the side wall of the key abuts the side wall of the outer cap when the at least one projection of the key is engaged with the at least one driving structure of the inner cap.

According to certain embodiments, the key is dimensioned and configured so that the at least one projection will align with the at least one aperture of the outer cap upon aligning the side wall of the key with the side wall of the outer cap and rotating the key with respect to the outer cap. Upon the at least one projection of the key becoming aligned with the at least one aperture of the outer cap and engaging the at least one driving structure of the inner cap, the side wall of the key is operable to slide down the side wall of the outer cap.

According to some embodiments, the key further includes at least a second projection and a second side wall extending from the top surface in a second direction opposite the first direction, the second projection and second side wall dimensioned and configured to correspond to a second outer cap of different dimensions than the first outer cap.

DETAILED DESCRIPTION

The present disclosure provides a closure system that provides a user the option to easily convert a non-child resistant closure system to either a “child resistant” or “child proof” closure system depending on the difficulty desired in removing the closure system from a container. While the closure system is primarily directed for use with containers intended to store and dispense pharmaceutical products, and particularly prescription pharmaceuticals, it should be understood that the system may also be used for other applications such as household cleaners, pesticides, and any other product containing dangerous chemicals. Further, it should be understood that the term “child proof” as used herein does not necessarily require it to be impossible for a child to open the closure system but is used to denote a configuration that is more difficult to open than a “child resistant” configuration by virtue of the system requiring a foreign object, and preferably a specially designed key, to remove the closure system from the container.

Referring to the flowchart ofFIG. 1, the closure system10of the present disclosure includes a non-child resistant cap (“NCR cap”)30, a child resistant element (“CR element”)50, a child proof element (“CP element”)70, and a key90. As will be understood from the description below, each of the NCR cap30, CR element50, CP element70, and key90are initially provided as separate and distinct structures. In a first non-child resistant configuration, the NCR cap30is configured to screw on and off an appropriate container in a non-child resistant mode to allow ready removal of the closure system10when only the NCR cap30is installed on the container. However, when a child resistant cap is desired, the CR element50is configured to be assembled with the NCR cap30to convert the NCR cap30to a child resistant cap. Alternatively, when an even more difficult to open closure system is desired, the CP element70is configured to be assembled with the NCR cap30to convert the NCR cap30to a child proof cap. In preferred embodiments, the CR element50and CP element70are configured to be permanently fixed to the NCR cap30. Thus, a user substantially unrelated to the manufacturer of the closure system10has the ability to 1) dispsense the pharmaceutical in a NCR cap30; 2) permanently convert the NCR cap30to a child resistant cap by assembling the NCR cap30with a CR element50; or 3) permanently convert the NCR cap30to a child proof cap by assembling the NCR cap30with a CP element70.

Accordingly, in step12, a user first determines whether a NCR cap30is desired or is all that is needed for the particular circumstances. For example, in step12, a pharmacist first determines whether the customer wants a NCR cap30(e.g., an elderly customer with no young children in their household) or whether the customer wants or needs a cap that is more difficult to remove from the container (e.g., a customer with small children at home). If only a NCR cap30is needed or desired, the user dispenses the pharmaceutical with just the NCR cap30installed to the container in step14. On the other hand, if the user determines in step12that a more difficult to open closure system is needed, the user next determines in step16whether a child resistant cap or a child proof cap is desired. When the user determines in step16that a child resistant cap is desired, the user assembles the CR element50with the NCR cap30to form a child resistant cap in step18and dispenses the pharmaceutical with the child resistant cap installed on the container in step20. However, when the user determines in step16that a child proof cap is desired, the user assembles the CP element70with the NCR cap30to form a child proof cap in step22and dispenses the pharmaceutical with the child proof cap installed on the container in step24.

As noted in step25, the child proof cap includes a child proof mode requiring a key90to remove the assembled child proof cap from the container. On the other hand, the child resistant cap includes a child resistant mode intended to make it difficult to remove the child resistant cap from the container, but stops short of requiring the separate key90. In certain embodiments, the child resistant cap may be removed only by applying a depressive force on the CR element50while rotating the cap (i.e., the child resistant cap is removed using a “push-down-and-turn” action as known in the art). However, in preferred embodiments, the child resistant cap is configured so that the key90may also be used to remove the assembled child resistant cap when desired due to the mechanical advantages of using the key as described below. Thus, as shown in step21, a customer that has been dispensed a child resistant cap is provided with an additional option of whether to screw the child resistant cap on and/or off the container without the key as shown in step21a(e.g., by applying a push-down-and-turn action) or with the key in step21b.

Additionally, referring to the flow chart ofFIG. 19and as further described below, the assembled child resistant cap and/or assembled child proof cap, according to certain embodiments, are further operable to be converted from the child resistant/child proof mode to a non-child resistant mode. In other words, the CR element50and NCR cap30may be configured to be assembled together to form a child resistant cap that is further convertible between a child resistant mode and a non-child resistant mode, while the CP element70and NCR cap30may be assembled together to form a child proof cap that is further convertible between a child proof mode and a non-child resistant mode.

In certain embodiments, the “user” is a traditional pharmacy that makes the determination of the type of cap to be installed on the container at the time of dispensing a prescription based on the preferences of the customer to which the prescription is being dispensed. In other embodiments, the user is a mail order pharmacy that makes the determination based on input from the customer order or stored preferences of the customer in the pharmacy database. In alternate embodiments, the prescription is dispensed to the customer with the NCR cap30installed on the container and the CR element50and CP element70provided separately to the customer. Accordingly, in this embodiment, the customer is a “user” that later makes the determination of the type of cap needed or desired after the pharmaceutical is dispensed with the NCR cap30thereon. For purposes of clarification, “user” generally refers herein to the individual or entity making the determination of how to assemble the closure system while the term “customer” refers to the individual or entity to which the user dispenses a container with the closure system10installed thereon in the chosen configuration. In certain circumstances, it should be understood that the “user” and “customer” may refer to the same individual or entity, such as when the “customer” makes the determination of whether to install the CR element50or CP element70to the NCR cap30after being dispensed a container with only the NCR cap30installed thereon.

One embodiment of closure system10is exemplified inFIGS. 2-16. According to this embodiment, as shown inFIGS. 2-5, the NCR cap30includes a closed top surface32, a circumferential side wall34extending downward from an outer periphery of the top surface32to create an open bottom surface36, a closure engaging mechanism38disposed on an interior surface33of the circumferential side wall34, and a plurality of driving structures40preferably disposed proximate the outer periphery of the closed top surface32. In preferred embodiments (for reasons explained further below) and as best shown in the exploded view ofFIG. 5A, each of the plurality of driving structures40are best described as “pockets” that include a recess42formed into the top surface32, where the recess42includes a bottom wall41that is coaxial with the top surface32and a pair of opposing side walls43extending substantially perpendicular from the bottom wall41to the top surface32.

The closure engaging mechanism38of NCR cap30is dimensioned and configured to engage in conventional manners a corresponding engaging mechanism of a container such that the closed top surface32covers the opening of the container. Thus, as noted above, the NCR cap30is configured to be installed and removed from the container in a non-child resistant mode to allow ready removal of the closure system10when only a non-child resistant mode is desired by the user. In preferred embodiments, the closure engaging mechanism38is a single thread disposed on the interior surface33of the circumferential side wall34as shown. However, the closure engaging mechanism38could also be a double thread, one or more beads, or other similar engaging mechanisms known in the art. The NCR cap30may also include a gripping element37disposed on an exterior surface35of the circumferential side wall, such as knurlments, to provide a gripping surface for screwing on and off the NCR cap30in the non-child resistant mode (i.e., when the NCR cap30is used unassembled from the CR element40and CP element60).

Referring toFIGS. 6-10, the CR element50also includes a top surface52and a circumferential side wall54extending downward from an outer periphery of the top surface52to create an open bottom56. The CR element50is shown as having an open top surface52such that a portion of the closed top surface32of the NCR cap30is visible when the CR element50is assembled with the NCR cap30, but the CR element50may alternately include a solid top surface not allowing the NCR cap30to be visible in the child resistant configuration. Similar to the NCR cap30, the circumferential side wall54may include a gripping element57to facilitate rotation of the CR element50.

The interior surface53of the circumferential side wall54includes a tab element58for engaging the bottom surface36of the NCR cap30to secure the NCR cap30within the CR element50. While the tab element58could be a solid or segmented bead, the tab element58is preferably a plurality of ramps as shown. As best shown in the cross-sectional view ofFIG. 9A, each ramp58includes an angled ramp surface57leading to a substantially flat surface59that is substantially perpendicular to side wall54. The angled ramp surface57facilitates the side wall34of the NCR cap30in traversing the side wall54of the CR element50until the flat surface59engages the bottom surface36of the NCR cap30. Once the flat surface59of the CR element50engages the bottom surface36of the NCR cap30, the NCR cap30is generally considered permanently assembled within the CR element50to prevent any unwanted shelling or removal of the CR element from the NCR cap30. It is noted that, with this configuration where the NCR cap30slides through the open bottom56of the CR element50, the CR element50is operable to be installed either before or after the NCR cap30is installed on a container.

The CR element50is further provided with a plurality of driving structures60disposed along the interior of the top surface52operable to engage the plurality of driving structures40of the NCR cap in the child resistant configuration. In this regard, the driving structures40and60are preferably dimensioned and configured such that the driving structures60of the CR element50freely engage the driving structures40of the NCR cap30when the CR element50is rotated in a first direction, preferably in a clockwise direction, thereby permitting the closure engaging mechanism38of the NCR cap30to be rotated along a corresponding container engaging mechanism for securing the assembled closure to a container in the child resistant configuration. However, when the CR element50is rotated in a second direction to remove the assembled closure from the container, a depressive force is required in order for the driving structures60of the CR element50to engage the driving structures40of the NCR cap30. Thus, assembling the CR element50with the NCR cap30preferably converts the NCR cap30to a “push-down-and-turn” child resistant cap.

As best shown in the exploded view ofFIG. 9B, each of the plurality of driving structures60of the CR element50is preferably in the form of a ratchet ramp having an at least partially angled ramp surface62that ends at a vertical member64extending towards and substantially perpendicular to the top surface52of the CR element50. Accordingly, when turning the CR element50in the first direction, the plurality of ratchet ramps60of the CR element engage the plurality of recesses42of the NCR cap30via each vertical member64engaging an appropriate side wall43of a recess42. However, when turning the CR element50in the second direction, the ramp surfaces62are unable to engage the opposing side wall43of the recesses42without a depressive axial force being applied to the CR element50. In other words, while the ratchet ramps60are able to engage the driving structures40to turn the NCR cap30in the first direction via simply rotating the CR element50for installing the assembled child resistant cap onto a container, the ramp surfaces62are configured so that the ratchet ramps60are unable to engage the driving structures40in the second direction unless a user applies a “push-down-and-turn” action on the assembled closure.

Referring toFIGS. 11-13, the CP element70also includes a top surface72, a circumferential side wall74extending downward from an outer periphery of the top surface72to create an open bottom76, and a plurality of ramps78for engaging the bottom surface36of the NCR cap30to secure the NCR cap30within the CP element70. However, unlike the CR element50, the interior surface of top surface72is preferably substantially smooth or otherwise does not include any driving structures operable to engage the driving structures40of the NCR cap30in the child proof mode. Thus, a customer is unable to remove the assembled child proof cap from a container when the closure system is in a child proof mode by applying a “push-down-and-turn” action on the assembled closure. Similarly, according to this embodiment, a customer is unable to install the assembled child proof cap on a container when the closure system is in a child proof mode. In order to remove the child proof cap, the CP element70includes one or more apertures84extending through the top surface72such that a key90may be inserted through the one or more apertures84to engage the NCR cap30. Upon engagement, the NCR cap30may be screwed on and off a container by rotating the CP element70and/or key90in the appropriate direction.

In an alternate embodiment of CP element70, the interior top surface includes modified driving structures configured for permitting the NCR cap30of the assembled child proof cap to be rotated in the first direction for screwing the cap onto a container while preventing the NCR cap30of the assembled child proof cap from being rotated in the second direction for screwing the cap off a container even when a depressive force is applied. For example, CP element70could include ratchet ramps similar to the ramps60of CR element50but with an elongated ramp surface configured to be unable to engage the appropriate side wall43of NCR cap30when the CP element70is rotated in the second direction even when a depressive force is also applied. In addition, one or both of the CP element70and NCR cap30may be provided with a slip agent or additive that further assists in preventing the ratchet ramp of the CP element70from driving structure40of the NCR cap.

In embodiments with a slip agent, the slip agent includes an ultra high molecular weight (“UHMW”) polymer molded into the CP element70and/or NCR cap30to serve as a lubricating agent and provide enhanced lubricity between contacting surfaces. In preferred embodiments, the UHMW polymer, a term used to refer to macromolecules with molecular weights that exceed 106g/mol, is selected from a polymer such as polyethylene, polypropylene, polystyrene, polyisobutylene, polyacrylamide, polyisoprene, polyethyleneoxide, polytetrafluoroethylene, polymethylmethacrylate, polyvinylalcohol, polyacrylicacid, polyvinylacetate, nylon-6, nylon-4, and siloxane. In most preferred embodiments, the UHMW polymer is UHMW siloxane. In typical embodiments, the UHMW polymer is provided as an UHMW lubricating additive that includes approximately 25-70%, and most preferably about 50%, of the UHMW polymer dispersed in a thermoplastic carrier resin such as high-density polyethylene (HDPE), polypropylene (PP), acetal, high impact polystyrene (HIPS), or styrene-acrylonitrile (SAN). In preferred embodiments, the carrier resin is a HDPE polymer. A compatible UHMW lubricating additive having siloxane as the UHMW polymer and a HDPE polymer as its carrier resin is available commercially as DOW CORNING® MB50-314 Masterbatch.

According to this alternate embodiment, the amount and type of the slipping additive, as well as the slope of the ramp surfaces, can be varied as desired to vary the ability to open the container without the use of a key as described below. In preferred embodiments, the slope and slipping additive are used to make it essentially impossible to remove the child proof cap from a container. However, in certain embodiments, it may be desired to allow for both a highly forceful push-down-and-turn functionality in addition to the key opening.

As exemplified inFIGS. 14-16, the key90includes a handle portion, at least one unlocking pin or projection98extending from the handle portion, and a key ring aperture99for securing the key90to a user's key ring to prevent loss of the key90. While a preferred key is shown and described below, it should be understood that many different types of key configurations and designs may be utilized within the scope of the present disclosure such that the key includes a projection operable to engage the NCR cap30through the CP element70. It should also be understood that the projections98of key and apertures84of CP element70may be configured to engage any appropriately configured driving structure of NCR cap30within the scope of the present disclosure. However, in preferred embodiments and as exemplified in the NCR cap30, CP element70, and key90shown inFIGS. 2-16, the projections98of key90and apertures84of CP element70are each positioned and configured so that they may be vertically aligned with the driving structures40of the NCR cap30upon rotation of the CP element70with respect to the NCR cap30. Thus, upon vertical alignment, the projections98of key90may be inserted through the apertures84of the CP element70to engage the same driving structures40of the NCR cap30that ramps60of CR element50are configured to engage. As a result, the NCR cap30does not require an additional structure for receiving the key and the NCR cap30is able to include a solid interior top surface (i.e., the problem described in the Background section herein of prior art key related closure systems having a centrally located pocket having a necessary depth that extends into the interior space of the inner cap to receive a key is avoided), which allows the closure system10to be induction sealed and reduces the amount of resin needed to mold the NCR cap30.

In addition to using the same driving structures40to engage the driving structure60of the CR element50and the one or more projections98of key90through the CP element70, configuring the driving structures40to include “pockets” as described above with opposing perpendicular side walls43and the driving structures60of the CR element50as ratchet ramps60(as opposed to the ratchet ramps being included on the inner cap of traditional two-piece push-down-and-turn child resistant caps) provides the multi-faceted closure system10with the ability to use the same NCR cap30for both the assembled child resistant cap and the assembled child proof cap. In this regard, the pockets40(1) are not used when the NCR cap30is installed alone on the container in a non-child resistant mode; (2) provide an appropriately configured driving structure that is operable to be engaged by the ramps60of the CR element50when rotating the CR element50of the assembled child resistant cap in both the first direction and the second direction (with the second direction also requiring a depressive force); and (3) provide an appropriately configured driving structure that is operable to be engaged by the projection98of key90such that the key90may be used to rotate the child proof cap in both the first direction and second direction (or engaged by the key90through an “enhanced” CR element50that provides the customer with the option of using the key90to screw on and off the assembled child resistant cap).

Yet another advantage of adapting the driving structure40of the NCR cap30to include pockets configured to receive the projection98of key90is that the height of the NCR cap30is able to be decreased, resulting in a more aesthetically pleasing appearance of the closure assembly10and a closure assembly10that may be produced more efficiently. The reduction in size is a result of the NCR cap30(1) not needing an additional indention to receive the key; and (2) the inclusion of pockets40disposed within the top surface32of NCR cap30instead of ramps or other locking mechanisms protruding from the top surface32. In preferred embodiments, the thickness of the top surface32of the NCR cap30is about 1.25 mm to about 1.5 mm with the recess42extending about 0.9 mm to about 1 mm into the top surface32.

While key90may include only one projection98, in preferred embodiments and as shown inFIGS. 14-16, the key90includes at least one set of spaced apart projections98that are operable to be inserted through appropriately spaced apertures84of CP element70to engage a plurality of the pockets40of NCR cap30. Due to the spaced apart projections98engaging a plurality of pockets40along the outer periphery of the NCR cap30, use of the key90adds a significant fulcrum effect/mechanical advantage to the customer and enables the child proof cap to be more easily tightened and removed by rotating the key90as opposed to the CP element70. Further, as shown, the handle portion of key90may also include a width that is substantially equal to or greater than the diameter of the CP element70to further increase this mechanical advantage. Accordingly, use of key90is multifunctional—it unlocks the child proof cap and also converts the child proof cap into an easy open container upon proper use of the key90. Thus, as noted above, the CR element50of preferred embodiments also includes similar apertures64to apertures84of CP element70to take advantage of this mechanical advantage if desired with the child resistant cap by using key90. This “enhanced” child resistant cap (i.e., “enhanced” by virtue of also permitting a key to be used to screw on and off the cap with respect to a container) is particularly useful for the elderly that have trouble opening child resistant closures but also have caregivers that often dispense their medications. Thus, the elderly individual may use the key90to remove the child resistant cap themselves, while the caregiver may open the container using the normal child resistant function. Also, the enhanced child resistant cap is beneficial when the child resistant cap is secured to a container in an automated dispensing system as inspection workers can use the key90to easily screw on and off the child resistant caps from the containers being inspected and alleviate carpal tunnel syndrome symptoms.

In yet another aspect of the disclosure, the apertures84of CP element70(or apertures64of the enhanced CR element50) are preferably sufficiently small such that the potential for alignment of the apertures84with the driving structures40of the NCR cap30is not immediately discernible when viewing the assembled child proof cap, at least to a child. In particular, due to the small size of apertures84, it is not immediately recognizable that the NCR cap30even has driving structures40when assembled with the CP element70. Further, the small size of apertures84prevent typical household items such as coins, screwdrivers, etc. from being used as keys. Thus, according to preferred embodiments, the set of small projections98of key90and small apertures84of CP element70are provided to prevent people from removing the child proof cap unless they have the specially designed key90, and, even if they have the key90, know exactly how the key90should be used to remove the child proof cap installed on a container in the child proof mode. Such a system not only “child proofs” the closure, but the system serves as an effective deterrent for older adolescents as well as house visitors that do not have easy access to the specially designed key. In preferred embodiments, apertures84are less than about 3 mm in diameter, however it is noted that the size can vary depending on the stiffness and strength of the material used for forming the projections98of the key90as stronger materials for the projections98(e.g., steel) permit the projections98to be even smaller.

In order to assist in alignment of the projections98of key90with the apertures84of the CP element70, the handle portion of the key90is preferably dimensioned and configured to correspond to the dimensions of the CP element70(or to correspond to apertures64and dimensions of the enhanced CR element50). For example, as shown, key90preferably includes a top/base surface92and a circumferential side wall94extending from an outer periphery of the top surface92to form a bottom key opening96. The projections98extend from the base surface92in axial alignment with the circumferential side wall94, and the circumferential side wall94includes an internal diameter that corresponds to the outer diameter of the CP element70(e.g., the internal diameter of the side wall94is slightly greater than the outer diameter of side wall74). As a result, the key90may be placed over the child proof cap such that the base surface92of the key90is placed over the top surface72of the CP element70and the internal surface of side wall94of the key90at least partially extends down the external surface of side wall74of the CP element70. The projections98are then positioned such that rotation of the key90with respect to the CP element70results in the projections98of key90becoming aligned with apertures84of the CP element70. The projections98then become aligned with the recesses42of the NCR cap30upon further rotation of the key90such that the side wall94of key90slides further down the side wall74of the CP element70. At this point, the top surface92of the key90is contacting the top surface72of the CP element70, and the customer knows that the key90is aligned with the child proof cap such that rotation of the key90will rotate the cap on and off the container.

According to an alternate embodiment, only a portion of side wall94extends from the base surface92such that side wall abuts only a portion of side wall74of the CP element70. To align, the portion of side wall94is rotated along the side wall74until the one or more projections98align with the one or more apertures84.

To further assist a customer in aligning the projections98with apertures84of CP element70, the exterior surface75of side wall70preferably includes a discrete alignment feature indicating the location of the apertures84on the top surface72of the CP element70. In preferred embodiments, and as shown in the drawings, the alignment feature includes a small break88in the knurlments77of the CP element70(and breaks68in knurlments57of an enhanced CR element50). Similarly, the key90may also include breaks97in knurlments indicating location of the projections98. Such breaks in the knurlments are not only visible to a person with relatively good eyesight, they are able to be located by feel by those with poor eyesight.

Referring toFIGS. 17-18, another embodiment of key90is shown designed to open closure systems of different sizes. Thus, according to this embodiment, the top surface92includes a first side91and a second side93. A first circumferential side wall94extends from the first side91in the same direction as projections98while a second circumferential side wall95extends from the second side93in the same direction as another set of projections98. As shown, the first circumferential side wall94includes a greater diameter to correspond with CP elements70having larger diameters while the second side wall95includes a smaller diameter to correspond with CP elements70with smaller diameters. As shown, instead of breaks in the knurlments, another alignment feature could include projections97from the side walls at the location of the projections98.

In yet another aspect, the NCR cap30preferably includes indicium warning the user that the closure system10is in a non-child resistant mode (i.e., CAUTION: NOT CHILD RESISTANT) that is visible only when the NCR cap30is installed on the container unassembled from the CR element50or CP element70. For example, indicium may be positioned on the closed top surface32such that it is covered by the CR element50when the closure system is in a child resistant configuration or covered by the CP element70when the closure system is in a child proof configuration. In particular, when the CR element50and CP element70include an open top surface as shown, the indicium is disposed around the periphery of the top surface32of the NCR cap30. While the indicium may be molded directly into the top surface32, the NCR cap30is preferably see-through such that the indicium may be provided on a liner that is inserted into the interior of the NCR cap30. Further, in embodiments where the warning is disposed on the outer periphery of the liner, the interior portion of the liner may include additional indicium such as promotional messages, prescription instructions, etc.

Additionally, as shown, indicium may be provided on the top surface52of the CR element50informing the user that the structure is the CR element50and/or giving instructions on how to open the closure system10in the child resistant configuration. For example, the indicium may state “TO OPEN PUSH DOWN AND TURN,” which both gives notice to the user that the structure is the CR element50and provides opening instructions for the child resistant configuration. Similarly, indicium may also be provided on the top surface72of the CP element70informing the user that the structure is the CP element70and/or giving instructions on how to open the closure system10in the child proof mode such as “TO OPEN ALIGN KEY WITH HOLES” as shown. Alternatively, the function of the child proof cap may be hidden by using more discrete in identifying the CP element70and providing the operating instructions for the assembled child proof cap on the key.

Referring to the flow chart ofFIG. 19, another embodiment of closure system is provided where the child resistant cap and child proof cap further include a non-child resistant mode. In other words, the assembled child resistant cap is operable to be converted between a child resistant mode and a non-child resistant mode, and the assembled child proof cap is operable to be converted between a child proof mode and a non-child resistant mode.

Similar to the closure system10, convertible closure system110includes a NCR cap130, a CR element150, and a CP element170. In step112, a user first determines whether only the NCR cap130is needed. If only a NCR cap130is needed or desired, the user dispenses the pharmaceutical with just the NCR cap130installed to the container in step114. On the other hand, if the user determines in step112that a more difficult to open closure system is needed, the user next determines in step116whether a child resistant cap or a child proof cap is desired. When the user determines in step116that a child resistant cap is desired, the user assembles the CR element150with the NCR cap130to form a child resistant cap in step118. On the other hand, when the user determines in step116that a child proof cap is desired, the user assembles the CP element170with the NCR cap130to form a child proof cap in step122.

While the above is generally the same as closure system10, closure system110also gives the user and/or customer the option to convert the child resistant cap or child proof cap to either a non-child resistant mode or a child resistant/proof mode. For example, a customer may be an elderly person that lives by themselves but occasionally has grandchildren come visit. Thus, in step112for example, in addition to determining that a NCR cap is not sufficient, the user also determines that a convertible closure system110is preferred over a non-convertible system10. Then, prior to dispensing the child resistant cap or child proof cap as desired, the user determines in step119(after choosing a convertible child resistant cap) or step123(after choosing a convertible child proof cap) whether to dispense the pharmaceutical in the non-child resistant mode or the child resistant/proof mode and converts the requested cap in the appropriate step119a/bor123a/bprior to dispensing the requested cap in the desired manner in step120a/bor124a/b. As shown in step125, when the child proof cap is dispensed in the child proof mode, the customer must use key190to screw the child proof cap on and off. Further, as shown in step121, when an enhanced child resistant cap is provided in a child resistant mode (or the customer later converts an enhanced child resistant cap from the non-child resistant mode to the child resistant mode), the customer has the further option to screw the enhanced child resistant cap on and off a container without a key (step121a) or with a key (121b).

One embodiment of closure system110is exemplified inFIGS. 20-25. As shown, convertible closure system110is similar to system10described above except for a couple of key differences. First, as shown inFIGS. 20-21, NCR cap130includes an outer skirt146disposed adjacent the bottom surface136of the sidewall134. The outer skirt146includes a plurality of spokes147positioned thereon in axial alignment with the side wall134. The top surface132of NCR cap130also includes a dome148disposed proximate the interior of the driving structures140extending coaxially with the circumferential side wall but in the opposite direction from the top surface132. Then, as shown inFIGS. 22-25, CR element150and CP element170include a second tab element161,181disposed on the interior surface153,173of their respective side wall154,174above tab element158,178. Finally, the interior surface153,173of the side walls154,174include a plurality of spokes163,183disposed between their respective tab elements and in axial alignment with their respective side wall154,174.

These additions allow the NCR cap130to be positionable within the CR element150and CP element170between a non-child resistant mode and a child resistant/child proof mode. With respect to the child resistant mode of the assembled convertible child resistant cap, the outer skirt146of the NCR cap130is positioned above tab element161of the CR element150. In this child resistant mode, the driving structures160of the CR element engage the driving structures140of the NCR cap in a similar manner as described with respect to the driving structures60and40of closure assembly10. However, to convert the child resistant cap to the non-child resistant mode, the user/customer pushes down on the dome148such that outer skirt146of the NCR cap is disposed between tab elements158and161. In this non-child resistant mode, the plurality of spokes147of outer skirt146engages the plurality of spokes163on the side wall156to secure the NCR cap130within the CR element150. Thus, rotation of the CR element170in the non-child resistant mode causes the NCR cap130to be rotated when the assembled child resistant cap is installed on a container in the non-child resistant mode. The convertible child proof cap operates in a similar manner except a key is required to rotate the NCR cap in the child proof mode due to the CP element170not including any driving structures on its interior top surface.