The present invention relates to child-resistant safety caps and containers with such caps.

BACKGROUND OF THE INVENTION There is an increasing awareness of the need to protect children from inadvertently gaining access to medications, especially prescribed medications. Sometimes, ingestion of only one or two pills of a prescribed medication will prove fatal to a child. Moreover, there is an increasing awareness of the necessity to provide containers for prescribed medications that are readily and easily opened by an adult, that is, any person having the cognitive ability to understand the instructions for opening a pill container, which requires certain manipulation and manual dexterity. Such persons are assumed, as well, to have the ability to understand that the act of opening a pill container to gain access to the prescribed medication is a deliberate action, and is only undertaken when there is a necessity to attain access to the prescribed medication in the pill container.

There are several conventional, so-called,"childproof'or"child- resistant"pill containers in the market, which are generally employed by dispensing pharmacists for use in filling prescriptions, where the prescription requires that the pharmacist dispense one or more of a plurality of pills, tablets, gel-caps, capsules, or the like. For example, the container may include a"push-and-turn"closure for pill containers, or an"arrow- alignment"closure for pill containers.

The"push-and-turn"system for pill containers conventionally refers to a system in which the closure or cap for the pill container must be pushed axially downwardly and rotated at the same time to open the container. The "arrow alignment"system for pill containers conventionally refers to a system in which an arrow on the closure or cap must be aligned with an arrow on the pill container, such as one which is embossed on the container, in order to open the container. However, these containers are often complicated for adults to use.

Conventional container assemblies of the type where the cap or closure is integral with the container may have a fixed protrusion (also referred to as a"thumb tab") attached to the cap that is configured to assist in the opening of the cap. More typically, this fixed protrusion is opposite the hinge, and thus, acts as a lever to allow the intended user to open the container when a sufficient force is applied under the fixed protrusion.

However, these containers are easily opened by a child.

Therefore it is an object of the invention to provide an improved container and cap system which is child resistant, yet easily opened by an adult.

BRIEF SUMMARY OF THE INVENTION Containers with child resistant safety caps are disclosed herein. In one embodiment, the cap contains (1) an overlay portion and (2) a solid base.

The overlay fits over at least a portion of the cap's solid base. At an end of a first portion of the overlay, the overlay has a thumb tab for facilitating the opening and closing of the cap. Two notches are in the overlay's tubular skirt and located on opposing sides of the overlay where the first end portion meets the second end portion. When the cap is shut, the overlay is secured directly over the cap. If an upward force is only applied to the thump tab, and then the first end portion of the overlay is lifted up, the solid base of the cap remains secured to the container. If an upward force is applied to the thump tab while simultaneously, sufficient inward force is applied to opposing sides of the overlay so as to contact and secure the tubular skirt of the cap, then the solid base is of the cap is simultaneously lifted up along

with the first end portion of the overlay, thereby opening the container. In a second embodiment, the container and cap assembly contains a sliding part in the cap. The sliding part may be supplied separate from the container and cap assembly, allowing the user to determine if a child-resistant or non-child resistant cap is formed. In the child resistant embodiment, the sliding part is configured within the cap whereby at least a portion of the sliding part protrudes out from the cap in a location near or proximate to the hinge. To open the cap, the user applies sufficient force to the sliding part, pushing it in a direction away from the hinge so that at least a portion of the sliding part protrudes out of the portion of the cap that is substantially opposite the hinge.

Then the user applies a second sufficient force in an upward direction to open the cap.

BRIEF DESCRIPTION OF THE DRAWINGS Figures IA, 1B and 1C are perspective views of a container and cap assembly with solid base beneath the cap.

Figures 2A, 2Band 2C are side plan views of a container and cap assembly with solid base beneath the cap.

Figures 3A, 3B and 3C are side plan views of a container and cap assembly with solid base beneath the cap in a closed position.

Figure 4 is a top plan view of the Figure 3B embodiment.

Figure 5 is a side plan view of the Figure 3B embodiment in an open position.

Figure 6A is a top plan view of the Figure 5 embodiment.

Figure 6B is a top plan view of the Figure 3B embodiment in a closed position.

Figure 7 is a perspective view of the top portion of a container with a cap containing a sliding element in the closed position.

Figure 8 is perspective view of the top portion of a container with a cap containing a sliding element in the open position.

Figure 9 is an illustration of a kit containing a sliding element and a container with a cap with a space for a sliding element.

DETAILED DESCRIPTION OF THE INVENTION I. Definitions As generally used herein, a"child-resistant"cap or closure for a pill container means that the cap or closure was tested in the following manner.

When a child-resistant package is tested by a group of children, the child- resistant package cannot be opened by at least 85% of those children prior to a demonstration to them of the proper means of opening the package; and still cannot be opened by at least 80% of those children after they receive a demonstration of the proper means for opening the package. In the case where a child-resistant package is provided to a test group of adults, at least 90% of those adults must be capable of opening the package. Where the package is designed so that it may be re-closed, it can be re-closed by at least 90% of those adults but still cannot be opened by at least 85% of children to whom no demonstration of the proper method of opening the package has been given, nor by 80% of those children after a demonstration has been made.

As generally used herein, "moisture-tight"means the moisture ingress of the container after three days is less than about 750 micrograms of water, preferably, about 250 micrograms of water, more preferably, about 150 micrograms of water determined by the following test method: (a) place 1 gram i 0.25 grams of molecular sieve in the container and record the weight; (b) fully close the container; (c) place the closed container in an environmental chamber at conditions of 80% relative humidity and 72°F ; (c) after one day; weigh the container containing the molecular sieve; (d) after four days, weigh the container containing the molecular sieve; and (e) subtract the first day weight of the sample from the fourth day weight of the sample to calculate the moisture ingress of the container in units of micrograms of water.

II. Container And Cap Assembly 1. Container The container may have any shape that is suitable for storing medicaments. In the preferred embodiment, the container is in the shape of a

cylinder. Typically, the container is closed at one end and is open at the opposite end. Optionally, the container is open at both ends. Optionally, when the container is closed, the container is moisture tight.

The cap is attached to the container by way of a hinge. The cap also has a mating sealing element that interfaces with the open end of the container, thereby forming a container and cap assembly.

The assembly is preferably molded of plastic. Suitable material for assembly includes plastics like thermoplastics such as polypropylene and polyethylene. The assembly may be produced in accordance with the operation disclosed in U. S. Patent Nos. 4,783, 056 to Abrams, RE37, 676 to Abrams et al. or 6,303, 064 to Abrams et al. The disclosures of these patents are incorporated herein by reference.

Optionally, the container includes a lining of a material that absorbs or releases materials. As an example, if the material absorbs water vapor, it may be included to keep the contents at a low relative humidity since any moisture that permeates through the seal or is present in the container would be absorbed. The lining material may be a desiccant entrained plastic.

Suitable desiccant plastics include, but are not limited to those disclosed in US. Patent Nos. 5,911, 937; 6,214, 255; 6,130, 263; 6,080, 350; 6,174, 952; 6,124, 006; and 6,221, 446, all to Hekal. These disclosures of these patents are incorporated herein by reference. The lining may also release a gas, such as an inert gas that prevents oxidation of the enclosed medicament, a flavoring or fragrance, or moisture, in the case of a medicament that should not be allowed to dry out.

2. Container and Cap Assembly with solid base beneath cap One embodiment of the child resistant container and cap assembly is depicted in Figures 1-6B. As depicted in these figures, the assembly 10 has a container 20 having a base 28, an internal cavity 27, and an outer surface 25, an upper portion 21 and a lower portion 26. The assembly 10 also has a cap 30 which has a solid base 31 and a tubular skirt 33 extending perpendicularly and outwardly around the outer periphery of the base 31. The cap 30 includes an overlay 60, wherein the overlay 60 has a base 61 with an outer

periphery and a tubular skirt 62 extending perpendicular to the base around the outer periphery of the base and wherein the overlay is sized to fit over at least a portion of the cap's solid base 31 and tubular skirt 33. The overlay 60 has a first portion 65 and a second portion 66. At an end of the first portion 65, the overlay has a thumb tab 36 for facilitating the opening and closing of the container. The second portion 66 of the overlay 60 covers the area near the end location of where the cap is attached to the container by the hinge 40.

The thumb tab 36 and hinge 40 extend substantially perpendicular to and outward from the skirt of the cap 30. The second portion 66 of the overlay is secured to the cap's solid base 31. Two notches 67A and 67B (not shown), are in the overlay's tubular skirt 62 and located on opposing sides of the overlay 60 where the first portion 65 meets the second portion 66.

An overlay hinge 70 connects the first portion 65 with the second portion 66 of the overlay.

Optionally, the container also has a flange 24 projecting radially outwardly from the outer surface 25 of the container 20. The hinge 40 may also be attached to the container flange 24 Hinge and Overlay Hinge The hinge 40 and/or overlay hinge 70 may also have a recess 42 that functions as a bending point during the opening and closing of the container.

In one embodiment, the recess 42 is characterized by a relatively thinner section of plastic material which bridges thicker sections 41A and 41B. The recess 42 is a location which bends relatively easily and acts as the location where the hinge folds when the lid is closed, and as the location where the hinge opens when the lid is opened. In hinge 40, 41A is attached to the skirt of the cap and 41B is attached to the container.

Method of opening the cap When the cap 30 is shut, the overlay 60 is secured directly over the cap's solid base 31. If an upward force is only applied to the thumb tab 36, then the first portion 65 of the overlay is lifted up and bends at the overlay hinge 70 so that the second portion 66 remains fixed that results in the solid base 3 1 of the cap remaining secured to the container 20.

As shown in Figure 2C, if an upward force is applied to the thumb tab 31 while, simultaneously, a sufficient inward force is applied to opposing sides 68A and 68B of the overlay 60 so as to contact and secure the tubular skirt 33 of the cap 30, then the solid base 31 of the cap is simultaneously lifted up along with the first portion 65 of the overlay resulting in the container being opened.

A"sufficient force"is a force above a threshold that causes the opposing sides 68A and 68B of the overlay 60 to contact and secure the tubular skirt 33 of the cap 30, and allow the solid base 31 of the cap to be simultaneously lifted up along with the first portion 65 of the overlay resulting in an open container. Children who are of an age at which they cannot comprehend the dangers of taking medicines unintended for them, or large doses of medicines, etc. , do not generally possess the strength necessary to apply a force at or above the threshold.

A person of ordinary skill in the art would understand how to construct opposing sides 68A and 68B of the overlay 60 that bends only upon application of a sufficient force. In one embodiment, the cap includes a suitable amount of elastomer in the thermoplastic formulation used to construct opposing sides 68A and 68B.

Overlay in Cap The degree of coverage of the overlay 60 over the solid base 31 may vary from what is shown in the Figures, as long as the overlay serves the desired function. The overlay must be of a suitable size so that only the first portion 65 is lifted, if only an upward force is applied to the thumb tab, and both the overlay 60 (including both the first portion 66 and second portion 65) and the solid base 31 are lifted, if sufficient inward force is applied to 68A and 68 B while an upward force is applied to the thumb tab.

The second portion 66 may be secured to the solid base 31 in any suitable way as long as the second portion 66 remains secured to the solid base 31 when a force is applied only to the thumb tab. Suitable methods of securing include molding, co-molding, in-mold and adhesion methods.

Notches 67A and 67B may be any suitable size that does not prevent the second portion 66 from sufficiently bending when a force is applied to the thumb tab and sufficient inward force is applied to 68A and 68 B.

The degree of force that is required to lift the second portion 66 can be varied based on at least the following: the material of construction, the size of the notch, the location of the recess, the shape and depth of the recess and the size of the thumb tab.

3. Container and Cap Assembly with Sliding part in Cap and Kit As shown in Figures 7-9, the container and cap assembly 80 contains a sliding part 82 in the cap 84. Optionally, the container is moisture tight when it is closed. A kit containing the container and cap assembly 80 and the sliding part 82 may be provided in an unassembled form (see Figure 9).

Then the consumer can determine whether or not the child resistant feature is needed. The consumer can insert the sliding part 82 in the desired direction to form a child resistant cap or a non-child resistant cap. When assembled, the sliding part is inserted into the slot such that sliding part and slot are in parallel alignment and the sliding part extends longitudinally inside the slot.

In this way, the same container assembly could be configured one way to have the child resistant feature and another if this feature is not needed.

Figure 9 illustrates one embodiment of the unassembled sliding part 82 in relation to the integral cap and container assembly 90.

Child Resistant Container and Cap Assembly To include the child resistant feature, the consumer can insert the sliding part 82 in the opening in the slot 86 that is near or proximate to the hinge 40. Then at least a portion of the sliding part 82 protrudes out from the cap 84 in a location near or proximate to the hinge 40 when the sliding part 82 is not engaged by the user. Optionally, the container and cap assembly can be supplied to the consumer to include the sliding part inserted in the cap so that the assembly contains the child resistant feature.

When sufficient force is applied in two perpendicular directions, the user is able to open the cap. For example, as illustrated in Figures 7 and 8, the user applies sufficient force to slide the sliding part 82 in a direction

away from the hinge 40 so that at least a portion of the sliding part protrudes out of the portion of the cap that is substantially opposite the hinge (see Figure 8). While holding the sliding part in this position, the user then applies sufficient force in an upward direction (i. e. perpendicular to the first force) to the newly exposed portion of the sliding part 82 to allow the cap to be opened and the user to gain access to the contents inside of the container.

The sliding part 82 is configured so that a sufficient portion extends out of the cap, thereby permitting a user to apply sufficient force in an upward direction to open the cap.

The sliding part 82 returns to its original position when the user releases the force on it. Upon retraction, at least a portion of the sliding part 82 protrudes out from the hinge side of the cap 84 in a location near or proximate to the hinge 40 and substantially no portion of the sliding part protrudes out of the portion of the cap 84 that is substantially opposite the hinge.

Non-Child Resistant Container and Cap Assembly In the non-child resistant embodiment, not shown, the sliding part is inserted in the opening in the slot 86 that is on the side substantially opposite the hinge. At least a portion of the sliding part 82 protrudes out from the cap 84 in a location substantially opposite from the hinge 40. Then, the user is able to open the cap by merely applying an upward force on the portion of the sliding element that extends outside of the cap 84.

Sliding Part The sliding part is configured to fit within a slot 86 that is configured within the cap 84 (see Figure 9). Portions of the sliding part protrude from opposite sides on the sliding part. By way of example, the sliding part may contain two protruding portions 88A and 88B (see Figure 9). When the sliding part is inserted into the cap, these portions act as springs to keep the sliding element biased in the direction in which it was inserted. For example, if it contains the child resistant feature, the sliding part will be biased towards the hinge side of the cap. If it does not contain the child resistant feature, the sliding part will be biased towards the side substantially opposite

the hinge. Optionally, the slot in the cap is above the underside of the cap 90 so that it does not affect the moisture-proof characteristics of the container assembly.

In another embodiment, the container assembly 80 may be produced a two shot injection molding process or an in mold liner process. Optionally, the container assembly may be produced by assembling a molded container and a sleeve either automatically or manually.

Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. Such equivalents are intended to be encompassed by the following claims.