Receptacles – Closures – Pivotable
Reexamination Certificate
2002-11-07
2004-11-30
Ngo, Lien (Department: 3727)
Receptacles
Closures
Pivotable,
C215S201000, C016S361000
Reexamination Certificate
active
06824006
ABSTRACT:
BACKGROUND OF THE INVENTION
Child Resistant (CR) packages, pursuant to the Poison Prevention Packaging Act of 1970, fall into three broad categories: Vials or bottles with a CR cap or closure; blister packs with a removable barrier over the frangible lidding; and, pouches with tear-resistant material and concealed tear-notches. To qualify for a CR package under 16 CFR §'s 1700-1702, the package must undergo a test protocol. It is generally regarded, however, that packages which feature one or more of the following attributes would probably pass the protocol: A cognitive step, a sequence of steps, some dependence upon written instructions, or some strength or dexterity uncommon to children age 5 or below.
In recent years, requirements for Senior Friendly (SF) packaging have been added to the regulations. A package is considered to be Senior Friendly if it can be opened by a test panel in the age group 50-70. This age group is more likely than other adults to have medications in the home, and certain packages such as “push-down-and-turn” or “squeeze-and-turn” caps can be difficult to operate for someone with an arthritic condition. This difficulty would probably result in disabling the CR feature and ultimately defeating the purpose intended.
Some drug packages are exempted. The most notable example is packaging for oral contraceptives. Not only are the hormonal ingredients not particularly toxic to children, the typical configuration of a blister package permits only one-at-a-time dispensing which makes it more difficult to amass a harmful amount of drug. A particular oral contraceptive package known in the art provides other desirable functions and features. These include day, date or other indicia, a resettable start day for the regimen, a memory-aid to assist schedule compliance, a one-way advancement mechanism for indexing next dose, a single dispensing aperture to assure purposeful selection of the dose, and a protective case to safeguard the contents.
A commonly used oral contraceptive container providing many of the features and functions noted above has a compact design and includes a rotating, ratcheted “dial”, and a means to receive a blister containing a circular array of tablets in a unique orientation to the indicia and to the dispensing aperture. Typically, such a container has a body and a lid, or cover, connected by a hinge.
It would be desirable for drugs other than oral contraceptives to have such compliance and protection functionality. Drugs for chronic treatments and titration regimens where sequence and timing are critical are but two such examples. There are few, if any, such packages, however, which are also CR/SF. The present invention is directed to a CR/SF solution for a hinged-lid container. It relies on a cognitive step and an adult hand-span to achieve a safety profile with children. The cognitive step can be communicated in written instructions to adults, or may otherwise be intuitive to someone with broad experience, uncommon to children, in handling packages. The Senior Friendly claim is based on simple two-step operation combined with a diminutive hand-pressure requirement to open.
SUMMARY OF THE INVENTION
The present invention provides a child-safe container including a base shaped as an open-topped housing which supports a pivot defining a pivot axis. The container further includes a cover rotatably attached to the base by a hinge, such that an opening direction is defined by rotation of the base and cover about the pivot axis. The base and the cover are also translatable relative to one another in one or more preferred directions other than the opening direction. A means for latching and unlatching the cover is also provided. The means for latching and unlatching is operable exclusively in the preferred directions.
In one preferred embodiment, the child-safe container includes a base and a cover with side walls attached to at least one of the base and cover such that an interior space is enclosed. The base and cover are rotatably connected at a hinge having first and second members forming the joint. One of the members defines one or more slots while the other member defines one or more corresponding hinge pins. The hinge pin has a pin axis, serving as the pivot, and the pin is moveably retained within the slot of the other member such that translational movement back and forth is allowed in a preferred direction. The container also includes a latch having one or more pairs of interlocking surfaces supported by first and second bosses. These bosses form the connecting structures to the base and cover. The interlocking surfaces have the capability to move between locked and bypass positions relative to one another. The location of the bosses and the juxtaposition of the interlocking surfaces prevent rotation about the pivot in the locked position. Alternatively, rotation about the pivot is freed at the bypass position. The container further includes an attached spring interposed between the base and cover such that the latch is biased by the spring in the locked position. When a force is applied at the hinge in the preferred direction, the articulation of the hinge allows the latch to attain the bypass position where freedom to pivot the base and cover open gives access to the interior space.
In one particularly preferred embodiment, the preferred direction operates in a plane containing the pin axis and in a direction perpendicular to this axis. Pressure applied at the hinge slides the cover forward relative to the base and exposes a front edge useful in lifting the cover. In this case, the pin axis moves relative to the slot. A cut away section in the cover allows counter pressure to be applied to the base without interference as the cover slides forward.
In another particularly preferred embodiment, the preferred direction also operates in a plane containing the pin axis but in a direction parallel to this axis. Opposing tabs attached to the hinge members provide leverage points for a squeezing force. This force reconfigures the hinge along the pin axis. This reconfiguration moves the cover sideways relative to the base and exposes a side edge to facilitate lifting. In this case, while the hinge pin itself moves, the pin axis remains stationary relative to the slot.
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Ngo Lien
Ortho-McNeil Pharmaceutical , Inc.
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