Cover assembly for a medication dispenser

The present invention is a cover assembly including a cover for covering at least one compartment of a medication dispenser. The cover includes an inner and outer end portion. A locking tab is formed in the inner end wall of the cover for being received in a slot formed in the medication dispenser for securing the cover to the medication dispenser. The locking tab includes a weakened portion for allowing the cover to be fractured and separated from the locking tab as the outer end potion is lifted away from the medication dispenser during removal of the cover. The weakened portion fractures before the outer end portion of the cover is lifted a distance from the medication dispenser less than or equal to a minimum dimension of a pill for preventing removal of the pill from the at least one compartment without removal of the cover from the compartment.

FIELD OF THE INVENTION

The present invention relates generally to the field of medication dispensers and more particularly to a multiple unit container including several dose compartments each compartment covered with a cover including a fracturable tab with a system for preventing medication tampering.

BACKGROUND OF THE INVENTION

United States Pharmacopoeia Xix defines a unit-dose container as a single-unit container so designed that the contents are administered to the patient as a single dose, direct from the container. A single-unit container is defined as one that is closed in such a manner than none of the contents may be removed without obvious destruction of the closure, the contents of which are intended for use promptly after it is opened. Accordingly, each compartment of a single-unit container must meet the above definitions in order to be used in compliance with current federal regulations.

One type of unit-dose container which is currently available permits a pharmacist to place the unit dosages in the individual compartments and to seal the same therein (such containers are commonly referred to in the market as punch cards or bingo cards). A nurse simply breaks the seal on the individual pocket when the dosage is to be administered. Although this packaging has been generally successful, the removal of medication from an individual compartment requires potentially destructive pressure to be exerted against the medication in order to force the medication through the perforated seal on the opposite side of the compartment. Further, the required pressure to be exerted by a healthcare professional for medication dispensement may over time contribute to such professional developing various adverse health conditions such as carpal tunnel syndrome. Furthermore, the slits in the compartment seals may permit the undetected removal of certain forms of medication and finally, the outer shell of that container requires a paper seal or other adhesive means to prevent removal of the entire compartment containing insert therefrom.

An additional form of unit-dose container disclosed in the prior art is one in which the cover assembly for the individual compartments is simply frictionally held in place with no positive locking of the covers onto the compartments. Such design is unsatisfactory for it does not prevent the undetected removal of medication for medication may be removed and the cover replaced without detection.

The assignee of the instant invention has previously patented many types of cover assemblies for medication dispensers including a plurality of individual covers connected together by fracturable links. Each of the compartment covers includes an integral fracturable tab designed to be independently snap-fitted onto the container to hold the lines in place and to provide a secure and tamperproof closure of each compartment. In some of the fracturable links, the separation of the link from the remainder of the cover was enhanced by the utilization of a notch formed in the tab positioned adjacent the juncture of the tab to the cover top plate. For example, see U.S. Pat. Nos. 4,372,445; 4,735,318; 4,741,441; and 5,011,018.

Although the tabs of the earlier patents identified hereinabove did fracture in a satisfactory manner, there is a perception in the field that the covers of the prior art may be slightly raised, without fracturing the tab, so that medication may be removed from the compartment and then replaced in the compartment without detection. Further, there is the perception in the field that a cover may be removed from its compartment by fracturing the tab thereon with the cover then being able to be replaced on its compartment without the fracturing being visible. For example, if medication is returned to a pharmacy, the pharmacy must check each individual cover to ascertain if the cover has been fractured since the same is not readily perceptible or the medication must be discarded as a safety precaution.

Although Applicants believe that the aforementioned perception is in error, Applicants present invention is directed to address and correct such perception. Further, plastic manufacturers continue to modify the plastic used for constructing the covers. For example, polymer manufacturers have developed polymers which yield more flexible covers which are more difficult to fracture. For example, users are required to exert more pressure in order to fracture the cover. Consequently, such modifications require the lids to be re-designed in order to allow for tolerance in the plastic and to minimize the amount of pressure that a user must exert in order to fracture the cover.

Therefore, it would be desirable to configure a unit-dose container which was designed to positively prevent medication tampering.

SUMMARY OF THE INVENTION

Accordingly, the present invention is directed to a cover assembly for a medication dispenser to prevent the undetected removal of medication. In an embodiment, the cover assembly includes a cover for covering at least one compartment of the medication dispenser. The cover includes an inner end portion and an outer end portion. Further, a locking tab is formed in the inner end wall of the cover for being received in a slot formed in the medication dispenser for securing the cover to the medication dispenser. The locking tab may include a weakened portion for allowing the cover to be fractured and separated from the locking tab as the outer end potion is lifted away from the medication dispenser during removal of the cover. In an exemplary embodiment, the weakened portion fractures before the outer end portion of the cover is lifted a distance from the medication dispenser less than or equal to the minimum dimension of the pill for preventing removal of the pill from the at least one compartment without removal of the cover from the compartment.

In specific embodiments of the instant invention, the cover assembly is generally transparent and the inner end portion adjacent to the weakened area becomes opaque upon fracture of the weakened portion for indicating that the weakened portion has been fractured allowing removal of the cover. Further, the inner end portion adjacent to the weakened portion becomes opaque due to the formation of crazes within the inner end portion adjacent to the weakened portion prior to fracturing of the tab from the cover. In such embodiment, the cover is formed of an amorphous polymer. In further embodiments, the inner end portion adjacent to the weakened portion becomes opaque before the outer end portion is lifted a maximum distance of approximately seventy-nine thousandths of an inch (0.079 inch). In an alternative embodiment, the inner end portion adjacent to the weakened portion becomes opaque before the outer end portion is lifted a maximum distance of approximately sixty thousandths of an inch (0.060 inch). In even further exemplary embodiments, the weakened portion fractures before the outer end portion is lifted a maximum distance of approximately seventy-nine thousandths of an inch (0.079 inch) or approximately sixty thousandths of an inch (0.060 inch). Additionally, the weakened portion is defined by a pair of V-shaped notches extending inwardly into the sides of the locking tab. Moreover, a protrusion extending from at least one of the locking tab and the inner end portion of the cover may be included for pivotally engaging with the dispenser as the outer end portion of the cover is lifted for facilitating fracture of the weakened portion.

In accordance with an additional aspect of the present invention, a medication dispenser is provided. In an exemplary embodiment, the medication dispenser includes a container and a multi-compartment removable liner disposed within the container, the liner including a plurality of open-topped compartments. Each compartment within the multi-compartment removable liner holds one or more pills whereby pills placed within the compartments are maintained out of direct contact with the container. Further, the pills have a minimum dimension. In addition, a plurality of covers assemblies for covering respective ones of the compartments are included. Each of the cover assemblies includes a cover for covering the compartment. In the present embodiment, each cover includes an inner end portion and an outer end portion. In further embodiments of the cover assembly, a locking tab formed in the inner end portion of the cover is included for being received in a slot formed in the medication dispenser for securing the cover to the medication dispenser to cover the compartment. The locking tab may include a weakened portion that fractures for allowing the cover to be separated from the locking tab as the outer end portion is lifted away from the medication dispenser during removal of the cover from the compartment. Moreover, the weakened portion fractures before the outer end portion of the cover is lifted a distance from the medication dispenser less than or equal to the minimum dimension of the pills for preventing removal of a pill from the compartment without removal of the cover.

DETAILED DESCRIPTION OF THE INVENTION

Referring specifically toFIGS. 1 through 4, a medication dispenser or container12in accordance with an exemplary embodiment of the present invention is illustrated whereby a cover assembly10is mounted on a medication dispenser12positioned in a carrier14. The details of the medication dispenser12and carrier14are disclosed in U.S. Pat. No. 5,735,406. The medication container or dispenser12includes a bottom wall16, upstanding side walls18and20, and upstanding end walls22and24. In one embodiment, a liner26is provided in the dispenser12to define a plurality of compartments28, each of which are removably sealed by a cover30of the cover assembly10.

As illustrated inFIGS. 3 and 4, the unitary cover assembly10includes a sufficient number of individual compartment covers30for closing all of the compartments28of one liner26. In one exemplary embodiment, the cover assembly is unitary as shown inFIGS. 3 and 4. In an additional embodiment, an individual cover30will be positioned over the upper end of each compartment28. It is preferred that the cover assembly10be unitary allowing for efficient attachment of the cover assembly10to the liner26.

Referring now toFIG. 5, an exemplary embodiment of a cover30is provided. In the exemplary embodiment, each cover30is generally trough-shaped and includes a generally horizontally extended bottom32and opposite end walls, outer end wall34and inner end wall36and opposite side walls38and40extending upwardly therefrom. A semi-circular extension42at the top edge of the outer end wall34facilitates lifting the cover30to open a compartment28. At the top of the inner end wall36, an integral flange44extends generally horizontally away from the end wall36and flares outwardly to form fracturable links46for interconnecting a plurality of covers30so that they may be handled as an integral assembly10.

An advantageous feature of each compartment cover30is the locking tab48which functions to independently secure each compartment cover30to container12. In an exemplary embodiment, as illustrated inFIGS. 5,6, and7A each tab48is a generally flat, downwardly tapering member arranged parallel to the inner end wall36. The spacing between the tab48and the inner end wall36is just sufficient for receiving a container divider wall and a liner end wall between them. Each tab48is further provided with an upwardly facing shoulder50on the interior side thereof and a weakened upper portion52formed by a plurality of openings54which extend through tab48adjacent the juncture of the tab to flange44. Although it is preferred that a pair of the openings54be provided adjacent each of the side edges56and58of the tab48, it may be that additional openings54will be required in some situations and that they be positioned continuously across the tab48.

FIG. 7Billustrates an additional exemplary embodiment of a locking tab48′ in accordance with the present invention. Tab48′ does not include the openings54as illustrated inFIGS. 5,6, and7A, but is provided with a pair of V-shaped notches60and62which extend inwardly into the sides of the tab48′ to form a weakened area referred to generally by the reference numeral64.

FIGS. 5,6,7A,7B, and8illustrate structure on the tab48or48′ which may be used with either the tabs48or48′. In an exemplary embodiment, a pair of protrusions66and68extend from the tab48or48′ for engagement with the top wall70of the container12. In the present embodiment, the protrusions66and68act as pivot points against top wall70as the cover30is moved upwardly thereby enhancing the fracturing of the tab48or48′ so that the cover30may be separated from the container12.

As best illustrated inFIG. 8, the top wall70of container12extends between and is connected to the upper edges of both divider walls D1and D2. The top wall70cooperates with the divider walls D1and D2to define a plurality of elongated spaced apart openings72for receiving the tabs48of the compartment covers30. For example, when the cover assembly10is positioned on the upper end of compartment liner26, the tabs48on each of the covers30are received in the openings72. At the same time that the covers30are depressed into the individual compartments28of the liner26, the trough-shaped covers30close and seal each of the open-top compartments28. The outwardly protruding semi-circular extension42at the outer end of each cover30engages the outer side wall of the liner, as shown in the drawings, to positively seat the cover onto and within the liner compartment26.

During an exemplary use, when a compartment is to be opened, the outer end of a cover30is pivotally moved upwardly which results in a fracture of the tab48at the weakened portion52formed by the openings54or at the weakened portion64formed by the notches60and62with that fracturing being enhanced by the engagement of the protrusions66and68with the top wall70of the container. The fracturable links46connecting that cover to adjacent covers are similarly fractured. The openings54or the notches60and62permit the cover30to be easily fractured from the lower end of the link46in a clean and neat fashion or manner. That portion of the tab48which is positioned below the openings54or the notches60,62remains in position until a new locking tab48is inserted into the opening72causing the residual tab to fall into the trough-shaped cavity80.

Referring now toFIGS. 10 through 24, a further exemplary embodiment of a portable medication dispenser200in accordance with the present invention is illustrated. The dispenser200includes a unitary cover assembly202designed to prevent the undetected removal of medication. In various embodiments, the portable medication dispenser200may be designed to dispense a two-week supply of medication (FIGS. 10,11, and12) or two different one-week supplies of medication (FIGS. 13 and 14). InFIGS. 10,11, and12the medication dispenser200includes a container frame204which is divided into two sections206and208. In the embodiment, an inner wall210is labeled with the days of the week or the word “spare.”

It is contemplated that various labeling schemes may be employed without departing from the scope and spirit of the present invention. For example, compartments may be denoted for time of dosage. In the present embodiment, a two-week supply of medication is provided. As further illustrated inFIG. 12, a medication dispenser unit is assembled by placing liners216in section206and section208of the container204. The unitary cover assembly202is then placed in alignment with the individual compartments218contained within the liner216so that each compartment218is covered with a cover220except for the compartment labeled as “spare.” If one desires to provide a “spare” dosage of medication, an individual cover220may be placed over the individual compartment218.

In an alterative embodiment, as illustrated inFIGS. 13 and 14, the container frame204is divided into quadrants defined by inner wall210and walls212and214allowing the medication dispenser200to include two, one-week supplies of each type of medication. As illustrated inFIG. 14, the medication dispenser unit200is assembled by placing a total of four liners216into the container frame204, one into each quadrant defined by the inner wall210and walls212and214. The unitary cover assembly202is then placed in alignment with the individual compartments218contained within each liner216so that each compartment218is covered with a cover220. It is contemplated that the number of compartments as well as the labeling may vary depending upon user need. For example, the coloring of the container frame204may vary depending upon time of dosage, type of medication regime, and the like.

Referring now toFIGS. 15 and 16, an exemplary embodiment of the cover assembly202is provided wherein the cover assembly202is unitary. In the exemplary embodiment, the unitary cover assembly202includes a sufficient number of individual compartment covers220for closing all of the compartments218of one liner216except for the compartment labeled “spare.” Although the cover assembly202is illustrated as being unitary, it is contemplated that in additional embodiments individual covers220may be positioned over the upper end of each compartment218as is done traditionally only for the “spare” compartment. Utilizing a cover assembly202which is unitary allows for efficient attachment of the cover assembly202to the liner216.

In the exemplary embodiment, as illustrated inFIGS. 16 through 20, each compartment cover220includes a locking tab222which functions to independently secure each compartment cover220to the container frame204. In the embodiment, each tab222is generally flat, includes six sides, and arranged parallel to the inner wall210. Further, in the present embodiment, each tab222includes a pair of V-shaped notches224and226which extend inwardly into the sides of the tab222to form a weakened area referred to generally by the reference numeral222. The spacing between the tab222and the inner wall210is just sufficient for receiving a container frame204divider wall and a liner216end wall between them.

In further exemplary embodiments, as illustrated inFIGS. 18,19and20, each tab222may be provided with an upwardly facing shoulder230on the interior side thereof. It is contemplated that in additional embodiments, openings which extend through the tab may be included within the body of the tab in order to form a weakened area. In addition, in the exemplary embodiment, a plurality of protrusions232,221, and234extend from the tab222for engagement with a top wall236of the container frame204. In such embodiment, the protrusions232,221, and234act as pivot points against top wall236of the container frame204as the cover220is moved upwardly thereby enhancing the fracturing of the tab222so that the cover220may be separated from the container frame204.

Referring toFIGS. 19 and 20, an exemplary embodiment of the cover220is provided. In this embodiment, each cover220is generally trough-shaped and includes a generally horizontally extended bottom238, an outer end wall240, an inner end wall242and opposite side walls244and246extending upwardly therefrom. A semi-circular extension248at the top edge of the outer end wall240facilitates lifting the cover220to open a compartment. At the top of the inner end wall244, an integral flange250extends generally horizontally away from the inner end wall242and flares outwardly to form fracturable links for interconnecting a plurality of covers220so that they may be handled as an integral or unitary assembly.

With continued reference toFIGS. 19 and 20, in the exemplary embodiment, the center protrusion221is of a greater length than the outer two protrusions232and234. Protrusion221not only serves as a pivot point, but allows crazes252which form within the locking tab attachment area252(e.g. the area appears opaque) when the cover220is lifted to be magnified allowing an observer to more easily detect fracturing of a cover220. For example, the presence of the protrusion221allows the crazes252/opaqueness to be magnified approximately 1.5 to 1.75 times that measured to covers not including the protrusion221.

Referring now toFIGS. 20 through 24, an exemplary embodiment of the locking tab222designed to prevent undetected removal of medication is described. In this embodiment, the cover assembly202including the locking tab222is formed of a polymer so that upon application of certain levels of strain the transparent locking tab222will turn opaque allowing a user to be alerted to such handling. In an exemplary embodiment, the cover assembly202is formed of an amorphous polymer for such polymer includes the desired properties (e.g. crazes which cause the substrate to appear as opaque are formed within the bulk of the substrate at certain strain levels).

In an additional exemplary embodiment, the weakened portion of the locking tab222fractures and the locking tab attachment area252turns opaque before the outer end portion of the cover220is lifted a distance from the medication dispenser less than or equal to the minimum dimension of the pill for preventing removal of the pill from the individual compartment. In the embodiment, crazes appear within the locking tab attachment area252(e.g. the area appears opaque) when the cover220is lifted a specified distance, denoted as d inFIG. 23. For example, for packaging of pills in the smallest dimension (thickness) range of seventy-nine (79) to eight (80) thousandths of an inch (e.g. the smallest known), cover assemblies202are designed so that crazes may appear within the locking tab attachment area252(the top of the locking tab222) when the weakened portion222of the cover fractures before lifting the outer end portion of the cover220to a maximum of approximately seventy-nine (79) thousandths of an inch.

In an alternative embodiment, cover assemblies202are designed so that the weakened portion222fractures and the locking tab attachment area252appears opaque before lifting the outer end of the cover220to a maximum of approximately sixty (60) thousandths of an inch. Such embodiment allows for tolerance present within the plastic. It is contemplated that different straining points may be employed without departing from the spirit and scope of the instant invention as specified for different pill sizes. It is further contemplated that the separation may occur with the fracturing of the cover202from the medication dispenser200, but is not required.

In additional embodiments, the fracturing of the cover220results in an audible sound such as a “click.” Such feature provides an additional way of determining when a cover has been fractured. For example, the fracturing of a newly placed non-fractured cover will result in the generation of an audible clicking sound. If the previously fractured tab were to be placed back onto the cover frame, such activity would be detected by a user for a user would not hear the audible click when removing the previously fractured cover.

In even further exemplary embodiments, the amount of pressure required to be exerted by a user may be utilized to determine cover fracturing. For example, in order to fracture a newly placed non-fractured cover, a user must exert a greater amount of pressure in order to remove the cover when compared to amount of pressure required to remove a previously fractured cover which had been placed back onto the cover frame. Such feature provides an additional manner in which a user may detect cover fracturing.