Bottles and jars – Closures – Having warning means or means impeding closure removal
Reexamination Certificate
1999-03-18
2001-01-16
Newhouse, Nathan J. (Department: 3727)
Bottles and jars
Closures
Having warning means or means impeding closure removal
C215S231000, C215S311000, C220S229000, C206S370000, C604S001000, C424S435000, C424S439000
Reexamination Certificate
active
06173851
ABSTRACT:
BACKGROUND OF THE INVENTION 1. THE FIELD OF THE INVENTION
This invention relates to childproof containers and in particular to childproof containers for the interim storage of medicated oral dosage forms. 2. Description of the Prior Art
A large number of chronically ill patients, many of whom are convalescing at home, have been prescribed opioids for the pain associated with their disease. These opioids ease most of these patients' pain, but opioid levels cannot safely be raised to account for the phenomenon of “breakthrough pain.” U.S. Pat. No. 4,671,953 discloses a method for treating such breakthrough pain by administering a medicated oral dosage form, containing a strong drug such as fentanyl, in a dose-to-effect manner to such patients. Such a method has been shown to be effective in treating breakthrough pain. The method is also effective in treating post-surgical or other types of pain. A patient inserts the medicated oral dosage form into his or her mouth, and in only a few minutes, the effects of the fentanyl can be felt, relieving the breakthrough pain. Such a patient may become drowsy. Because the medicated oral dosage form may not have been fully consumed and the patient may not be able to dispose of it by rinsing under tap water, there are concerns that a child in the home, for example, will see the partially consumed medicated oral dosage form and will put it into his or her mouth.
Accordingly, what is needed in the art to calm such concerns is a container for a patient to store such a partially consumed medicated oral dosage form in such a way as to prevent a child from further consuming it. Preferably, the patient could then dispose of the remainder of the medicated oral dosage form properly at a later time, and could continue to use and reuse the container until the medicated oral dosage form is properly disposed of.
There are a variety of child resistant containers. For example, most drugs dispensed or sold over the counter today are placed in containers with child resistant closures. One such closure screws onto a container in a conventional manner, but cannot be removed simply by unscrewing it. Instead, it must be unlocked by applying sufficient force normal to the closure and can then be removed by simultaneously turning it. In another version, the closure is pressed onto the container, where it remains by friction fit. The closure can be popped off the container with sufficient force, but only if it is oriented in a predetermined direction. The correct orientation is usually obtained by lining up marks on both the container and the closure.
However, as has been noted by others, many child resistant containers are difficult for even some adults to open. For example, the elderly or infirm may find it difficult to exert sufficient force normal to a closure to unlock it, or may simply find it too arduous to grasp a closure to pop it or to turn it open. For many of these same reasons, conventional child resistant containers are not suited to the interim storage of partially consumed medicated oral dosage forms. A patient using a medicated oral dosage form to relieve breakthrough pain, for example, may be too drowsy or otherwise unable to exert sufficient force normal to a closure to unlock it or even to pop or turn it open. Such a patient could not open such a container and then reclose it to safely store a partially consumed medicated oral dosage form. The process of opening and reclosing such a container could very well be too arduous or simply impossible for a patient under the effects of such medication. Although another adult could perform this task for the patient, it is not feasible, financially or logistically, for a nurse or other such adult to be present every time pain occurs and/or every time a patient uses a medicated oral dosage form. Thus, a more easily accessible, yet effective child resistant container is needed.
SUMMARY OF THE INVENTION
The apparatus of the present invention in its broadest terms comprises (1) a container sized to hold a medicated oral dosage form, (2) means for allowing a medicated oral dosage form one-way access into the container in a relatively easy manner while still preventing the medicated oral dosage form from passing out of the container (one-way access means), and (3) child resistant means for allowing an adult to remove a medicated oral dosage form from within the container despite the one-way access means. This allows the user to bypass the one-way access limitations in accessing the interior of the container to properly dispose of partially consumed units. There are several embodiments of this invention.
The method of the present invention comprises using such an apparatus for the interim storage of medicated oral dosage forms so as to be able to use medicated oral dosage forms in the safest manner possible. The partially consumed oral dosage form is slid through the one-way access means into the container. An adult may subsequently remove the medicated oral dosage form at a convenient time, or the patient may do so after the effect of the medication has sufficiently subsided. The medicated oral dosage form may then be disposed of in a permanent fashion.
The container of the apparatus can be any suitable container of sufficient size to contain a medicated oral dosage form. It will be appreciated that the term “oral dosage form” as used herein includes tablets, lozenges, patches, pastilles and other oral dosage forms with holders and that these dosage forms may be dissolvable or nondissolvable. In one embodiment, the container is made of plastic and is opaque so that a child cannot see the contents of the container. In still another embodiment, the container may be cut with one or more elongated slots (or other openings of suitable size and shape) to allow the container's interior to be more easily flushed with running water.
One suitable one-way access means comprises (1) a flat or concave plastic membrane with slits extending radially outward from a central point in combination with (2) an opening formed in the container, the membrane covering or otherwise regulating access to the opening. The slits define segments in the plastic membrane and are of sufficient length to allow a medicated oral dosage form to pass through an opening in the membrane that is created when the medicated oral dosage form is pressed against and bends the segments. Thus, the plastic is of sufficient stiffness that some force is required to bend the pie-shaped segments. When the force is discontinued, the pie shaped slits return to their original position, closing the opening in the membrane. Because a medicated oral dosage form cannot pass back through the slitted membrane without the application of force, and because sufficient force is not available to press a medicated oral dosage form against the membrane from within the container, the slitted membrane substantially prevents the medicated oral dosage form from passing out of the container. It will be appreciated that a number of other slit patterns may be used. In one embodiment, the slits are radially extending arcuate slits.
One suitable childproof bypass means comprises (1) a child resistant closure and (2) an opening in the container covered by the closure. After a patient has inserted a medicated oral dosage form through the one-way access means, he or she may then later remove the child resistant closure and retrieve the medicated oral dosage form through the opening. In one embodiment of the invention, there are two openings in the container, one for the one-way access means and another for the child resistant bypass means. As stated above, removal of the closure allows for access to the interior of the container and removal and reuse of the medicated oral dosage form.
In the preferred embodiment, however, there is just one opening in the container, used to provide access for both the one-way access means and the child resistant bypass means. In that embodiment, the child resistant bypass means comprises (1) a child resistant closure and (2) an opening in the contai
Hague Brian
Shoemaker Steve
Anesta Corporation
Kirton & McConkie
Krieger Michael F.
Newhouse Nathan J.
LandOfFree
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