PT8588U - PACKAGING TO STORE AND DISTRIBUTE POTENTIALLY HAZARDOUS MATERIALS RESISTANT TO CHILD OPENING WHICH UNDERSTAND A PRE-LOADED CLOSURE MECHANISM - Google Patents

Abstract

A package for storing and dispensing potentially dangerous materials, such as medicament tablets or the like, said package being resistant to opening by children but readily openable by adults, particularly adults having impaired manual dexterity of their hands and/or fingers. In a particularly preferred embodiment, the package comprises a bottle (12), a collar (32) which is secured in place over the uppermost portion of the bottle (12) and a closure (52) which is secured to the finish portion of the bottle by means of complementary screw threads. The collar (32) preferably includes a pair of resiliently deformable spring-like pushtabs (34) containing vertical extensions (36) which engage interlocking teeth (62) on the innermost surface of the closure skirt (60) when the closure (52) is fully assembled onto the bottle (12). To remove the closure (52), the opposed pushtabs (34) must be manually depressed prior to applying unscrewing torque to the closure (52) to disengage the pushtab extensions (36) from the interlocking teeth (62) on the closure (52). In a particularly preferred embodiment, the spring-like pushtabs (34) are generally outwardly directed prior to application of the closure to the package. Advancing the closure (52) onto the package until the teeth (62) on the innermost surface of the closure's skirt (60) interlock with the vertical extensions (36) of the spring-like pushtabs (34) causes a degree of resilient deformation of the spring-like pushtabs (34) so that the vertical extensions (36) of the pushtabs (34) are in contact with and exert a preloading force against the corresponding innermost surfaces of the closure skirt once the closure has been securely applied to the package. Quite unexpectedly, it has been learned that preloading the vertical extensions of the reiliently deformable spring-like pushtabs against the corresponding innermost surfaces of the closure skirt in the foregoing manner considerably enhances the child resistance of the package without increasing the difficulty of opening for older adults or those having impaired manual dexterity. Methods for producing the improved package are also disclosed.

Description

Proc. 65.251 Case: 4494BR

SAFETY PACKAGING FOR STORAGE AND DISTRIBUTION OF POTENTIALLY DANGEROUS SUBSTANCES

TECHNICAL SCOPE

This invention relates to an improved packaging for storing and dispensing materials, which may be hazardous, in particular if they are ingested incorrectly. Such materials may be in solid state, in tablets, in granules, in powder form, in a semi-solid state, in pulp in the liquid state.

In a particularly preferred embodiment, this invention relates to a package for storing and dispensing medicaments, such as analgesic tablets or the like.

This invention further relates to an aperture-resistant package by the majority of the children contacting it, but which can be opened without extreme difficulty by adults with a certain degree of difficulty of manual mobility.

This invention also relates to a non-expensive manufacturing package for facilitating its disposal after the contents have been completely dispensed into the package. This invention further relates to methods for making such a package.

ORIGINS OF THE INVENTION

Child-resistant packaging is both a blessing and a nightmare. They are a large -3- / $ / $ Mod. 71 20,000 et. - 90 / Οβ 20 25

Proc. 65.251 Case: 4494 This is an idea to prevent children from opening potentially dangerous substances such as medicines, but for adults, especially for the elderly, such packaging can be a great hassle.

Due to the usual health situation in old age, the elderly tend to rely more on medication than a person with a middle age. However, making it easier for older people to access medicines is at the risk of making packaging more accessible for children and for the possible intake of medicines.

These problems are in the domain of the packaging industry, in particular the pharmaceutical industry. Several articles have been written on the subject. See for example the article " The Dual Vial " published in the 1988 Autumn edition of Stout magazine.

US Pat. No. 4,948,002, Thornck et al., Issued August 14, 1990, a carton which is in accordance with the above: is resistant to children without imposing an extreme difficulty for adults with manual difficulties (this patent is included herein by reference). This type of packaging presented good results in tests performed with children and with adults with motor difficulties. However, it has been found that the child resistance of the package can be carried even further without this making it more difficult for adults to open if the pressure tabs with springs containing vertical extensions (which engage snap teeth on the face inside of the closure edge) are ideally configured so that the application of the closure to the package requires a degree of deformation of the pressure tabs whenever the closure is applied to the package in full meeting and engagement conditions. This is usually achieved when the spring loaded tongues have a shape that allows them in their " 18'Sc · '

Proc. 65.251 Case: 4494 outer ends protrude outward to a degree prior to the closing of the closure on the carton. The practical effect of this configuration is such that the vertical extensions in the spring loaded tongues are at least to a certain degree preloaded such that a force is exerted against the inner surface of the catch edge as soon as the has been fully assembled to the carton.

OBJECTS OF THE INVENTION 10

Thus, it is the object of this invention to provide a package which exhibits improved child resistance without significantly increasing the difficulty of opening by adults with motor difficulties. 15 8 k 1 > 8

Mod. 71 20 25 30

Another object of this invention is to provide methods for the production of such improved packaging. DESCRIPTION OF THE INVENTION In a preferred embodiment, this invention comprises a package for dispensing potentially hazardous materials, such as medicaments, for example, analgesic tablets or the like. The package should comprise a bottle, a ring that fits the upper area of the bottle and a screw fastener, as is generally described in US Patent 4,948,002 to Thornock et al, or a child-resistant accessory of the type commonly US Patent Application No. 826,747 to Peter W. Hamilton, Robert S. Dirksing and Reuben E. Oder of January 28, 1992, under the title ADULT-FRIENDLY CHILD-RESISTANT ATTACHMENT FOR CONTAINERS USED TO STORE POTENTIALLY DANGEROUS MATERIALS [Child-resistant and easy-to-handle adult accessories for containers used to store potentially hazardous materials -, - - -

Proc. 65.251 Case: 4494BR]. Such accessories are shown in the US application series no. 826,747 and may be formed separately from the bottle or container used to house the medicament or any other potentially hazardous material and is then either secured to the container or can be integrally formed with the container. Regardless of its exact configuration and how it is formed, the ring should include a pair of spring loaded tabs with vertical extensions at the upper ends. The catch has a rim which includes a pair of engaging teeth, sometimes referred to as tabs, which resist the unscrewing of the catch after the catch has been fully applied to the catch, unless the opposed catching tabs on the ring are depressed in shape to loosen their vertical extensions of the engaging teeth on the inner face of the catch edge.

In the improved packages or accessories of this invention, the ring zone containing the spring loaded tongues to which the vertical extensions are secured is initially produced so that, in its deformed condition, the vertical extensions in the spring loaded tongues are more spaced than on the corresponding inner surfaces of the closure edge, when the closure is applied in its entirety to the package or accessory. The result is that the application of the closure to the package causes at least a degree of elastic deformation to the spring loaded tongues and / or the vertical extensions attached thereto, so that the vertical extensions are preloaded against the inner surface of the closing edge when the package or accessory is in its child-resistant phase.

It is believed that the preloading of the vertical extensions of the spring loaded tabs against the inner surfaces of the closure edge ensures positive closure with the interlocking teeth within the closure edge, even at locations where the closure-

Proc. 65,251 Case: 4494 manufacturing tolerances go beyond specific limits, ie the vertical extensions of the spring loaded tongues must always be subjected to sufficient internal movement to provide clearance to the engagement teeth within the closure edge by shape to allow the locking of the lock. If there is no preloading of the spring loaded tongues, deviations in the manufacturing tolerance can reduce the required amount of travel to the vertical extensions of the pressure tongues and thus enable the closure to be unscrewed by less depression of the tongues with spring loaded.

It is further believed that the adults with motor difficulties do not find in the preloading force exerted by the vertical extensions in the spring loaded tongues against the inner surfaces of the closing edge an additional cause of difficulty of opening due to the fact that the level preload is not so strong as to significantly increase the total force required to release the grooves and allow the closure to be unscrewed.

BRIEF DESCRIPTION OF THE INVENTION The summary concludes with claims relating to the present invention, but it is believed that this will be better understood with the following description in conjunction with the engravings: Figure 1 is a simplified perspective view of a preferred package of this invention. Figure 2 is a simplified cross-sectional view of the package normally shown in Figure 1 after the package has been assembled, this view being taken at a point perpendicular to the anti-rotation screws 28 on the bottle 12; -7- Figure 3 is a simplified cross-sectional view normally similar to that of Figure 2, showing transversality through anti-rotation screws 28 in the bottle 12; Figure 4 is a simplified cross-sectional view of the carton of Figure 2 taken along a line IV-IV of Figure 2; Figure 5 is a simplified partial perspective view of the carton of Figure 1 showing the position of the vertical extensions on the spring loaded tongues prior to the application of the closure to the package; Figure 6 is a side elevational view of a particularly preferred child-resistant attachment of this invention; Mod. 71 20,000 70. Figure 7 is a cross-sectional view of the fitting shown in Figure 1, having such view taken along section I-I of Figure 6; Figure 7A is a cross-sectional view of the child restraint of Figure 6 taken along section line Π-Π of Figure 6; Figure 8 is a cross-sectional view of the fitting shown in Figure 6 with the pressure tongues depressed, said view taken at a point corresponding to the section line I-I of Figure 6; Figure 8A is a cross-sectional view of the child restraint of Figure 6 with the pressure tongues depressed, said view being taken at a point corresponding to the line of section II-Π of Figure 6; 35-8-

Mod. 71 20,000 er. - 90/08

Proc. Figure 9 is a side elevational view of a child resistant fitting of the present invention wherein the finished zone is integrally molded into a vial; and Figure 9A is a cross-sectional view of a child-resistant attachment and a vial of Figure 9.

DETAILED DESCRIPTION OF THE INVENTION

Mod. 71 · 20,000 ex. Figure 1 shows a view of an improved child resistant package 100 of the invention. The basic package 100 is of the type commonly disclosed in US Patent 4,948,002 to Thornock et al., Issued August 14, 1990, hereby incorporated by reference. However, the present patent, in the context of the type of packaging Thornock et al, is intended to be an illustrative, non-limiting example. The package 100 is particularly suitable for storing medicaments. The package 100 is particularly well suited for storing medicaments, such as analgesic tablets 20. However, the advantage of using the packages of this invention is not limited to their use for medicaments or even tablets. The packages of this invention can be used to store and distribute almost all potentially hazardous materials, whether in the solid state, in the form of tablets, in grain, powder, semi-solid, slurry or liquid form. The appended description in the context of a package of tablets is only intended to facilitate a thorough understanding of particularly preferred embodiments of this invention. Figure 1 shows a bottle 12, which should be made of polyethylene, the most common and cheapest material for bottles intended for analgesics. The bottle 12 is to be blow-molded with a wall thickness between about 0.015 and about 0.050 inches (0.0381 and 0.127 cm). The particular bottle 12 shown in figure 1 has a base 14 with a 35 5 10 15

Mod. 71 - 20,000 ('. · 90/08 20 25 30

Proc. 65,251 Case: 4494BR elliptical transversality is substantially constant. In a preferred embodiment, the ratio of the smaller ellipse dimension to the larger ellipse dimension is about 0.7. The upper support zone 16 of the bottle 12 should be in the form of an elliptical cone. The angles included therein in the upper abutment zone 16 should be between 36 ° and about 70 °, as measured around the periphery of the bottle 12. In a particularly preferred embodiment, the base 14 has a major axis about 1.75 inches (4,445 cm), a minor axis of about 1.25 inches (3.175 cm) and an overall height of about 1.12 inches (2.8448 cm). The truncated cone height of the support zone 16 is about 0.75 inches (1.905 cm) in this model. Above the support zone 16 of the bottle 12 is a cylindrical finish zone 18, which, in the said model, has a height of 0.5 inches (1.27 cm). The three zones, base zone 14, support zone 16 and finishing zone 18 of the bottle 12, must be concentrically aligned on a common vertical axis. The finishing bore 18 is a function of the diameter (or other larger, if not round, size) of tablet 20 and the rate of tabletting. In particular, the inner finishing diameter 18 should be sufficiently large so as to minimize the binding of the tablets 20, the entry of the finish 18 from a sharp filling blow. After the inner diameter of the finish 18 is selected, the diameter of the upper end of the truncated cone is determined which comprises the support zone 16, i.e., is substantially the internal diameter of the finish 18. The angles included in the cone selected for the support zone 16 then determines the major and minor axis dimensions of the base zone 14. For analgesic tablets 20 with a diameter of about 0.375 inches (0.9525 cm), the major axis dimension of the base zone 14

Proc. 65.251 Case: 4494BR

Mod. 71-20,000 · 90/08 20 25 30 N / / if usually between about 1.5 and 2.5 inches (3.81 and 6.35 cm). The height of the base zone 14 is selected to provide the desired flow volume in the package 100.

Any suitable means (for example, a combination of screws and screw threads) may be used to loosely and loosely hold the catch 52 to the finishing zone 18 of the bottle 12, but complementary screws are preferred.

The screws 22 in the finish 18 should be double bolts, each having a main angle providing a distance of between about 0.1 and about 0.13 inches (0.254 cm and 0.3302 cm) by half rotation. The toothed recess 24 situated in the abutment base 16 of the bottle 12 and outwardly projecting the rim 26 located at the upper end of the abutment zone 16 of the bottle 12 provides a fitting of the ring 32, also shown in Figure 1. Such as described below, the anti-rotation screws 28 starting from the support zone 16 of the bottle 12 just below the outwardly projecting rim 26 are intended to engage the ring 32 in order to prevent rotation of the ring 32 with respect to the bottle 12 when a withdrawing force is applied to the catch 52. The ring 32 must be formed from injection molding, the outer shape of a truncated cone which intersepates an elliptical cylinder in the same way as the base 14 of the bottle 12. The ring 32 should be made of a polymer having a folding module suitable to provide a pair of elastically deformable spring loaded lugs 34. In the model shown in Figure 1, the pressure tabs 34 are molded so as to be cantilevered at their rest position on the opposing conical sides of the ring 32. They should have a thickness substantially equal to that of the walls of the ring 32, i.e.,

Mod. 71 · 20,000 e *. 90/08 20 25 30

Proc. 65.251 Case: 4494BR

between about 0.040 and about 0.060 inches (0.1016 and 0.1524 cm).

Each spring pressure lug top 34 has an extension 36 which projects above the upper edge of the ring 32. The vertical pressure lug extensions 36 engage the teeth 62 on the inner surface of the outer edge 60 of the catch 52 when the catch 52 is fully screwed into the finishing zone 18 of the bottle 12. As can be seen in the perspective view of Figure 5 and the cross-sectional view of Figure 4, the spring loaded tongues 34 must have the shape that, that their vertical extensions 36, which project above the upper edge of the ring 32, have a dimension Xj, as measured through their outer surfaces, which is slightly larger than the corresponding internal dimension X 2, which corresponds to the points of contact between the vertical extensions 36 and the opposing inner surfaces of the catch edge 60 immediately adjacent the catch teeth 62 when the catch 52 is fully r in the package. As a result of the dimension Xj being slightly larger than the dimension X 2, the application of the closure to the package causes a degree of deformation of the spring-loaded pressure tabs 34 and / or of the vertical extensions 36 attached thereto, since the teeth 62 at the edge lock 60 pass, thereby preloading the outer surfaces of the upstanding extensions 36, against the corresponding inner surfaces of the edge 60 when the catch is in its fully engaged position. This is represented by the outwardly directed forces F1, as shown in the cross-section of figure 4. Although the difference in dimensions X1 and X9 may be relatively small, for example in the range of from about 0.001 to about 0.050 inches (0.00254 and 0.127 cm), it has recently been found that the improved packages of this invention using spring loaded spring pretensioners 34 pre-

Proc. 65.251 Case: 4494BR © • te * ?. loaded cells significantly increase the resistance to the children in the package without causing at the same time an extreme difficulty of opening to the adults with motor difficulties.

For a package that fits in the palm of the user's hand and which should be opened by applying the thumb and the index finger to the opposing spring members 34 to release the teeth 62 in the catch edge 60, thus allowing unscrewing of the catch 52 of the package, the amount of preloading force exerted by the vertical extensions 36 against the corresponding interior surfaces of the catch edge 60 does not have to be extremely strong. For example, it has been found that forces ranging from about 0.01 to about 2.00 pounds (0.00453 and 0.906 g) have a good result when measured by pressure against the upper end of one of the pressure tongues with opposing springs 34. In a preferred embodiment, a preloading force F1 of about 0.25 pounds (0.113 g), as measured by pressure against the upper ends of the opposing spring pressure tabs 34, is very well functioning to improve resistance to children and to avoid any significant increase in difficulty when packaging is opened by adults with a degree of motor difficulty. The precise phenomenon producing the above result is not fully understood, but it is to be noted that preloading the tabs with springs 34 in the aforesaid manner ensures that the vertical extensions 36 always have to be displaced to be released from the teeth 62 at the closure edge 60. Specifically, if the outer surfaces of the upstanding extensions 36 are always held in physical contact against the corresponding interior surfaces of the catch edge 60, the opposing spring catching tabs 34 always undergo a movement so that the vertical extensions 36 release the teeth that engage the inner surface of the catch edge.

In addition, since children do not understand the -13-

Mod. 71 · 50,000 e *. - 90/08 20 25 30

Proc. If the mechanism by which the aperture occurs in a container which is resistant to them, it is believed that the preloading of the spring loaded lugs 34, which offers an initial degree of resistance to their depression, naturally tends to discourage children while attempting to depress the pressure tabs further while applying a force of unscrewing to the catch 52. This, in turn, reduces the chances of the catch being inadvertently opened by one who does not understand the mechanism.

Perhaps even more importantly, since the improved packagings of this invention do not create difficulty in opening up for elderly or distressed adults, adults are more likely to re-apply the closure in the package once the required amount of content has been removed, not leaving the clasp only partially secured or fully open.

Finally, the improved packages of this invention using spring loaded tabs 34 allow for a "click" hearing whenever the teeth 62 of the catch member 52 are advanced into the upstanding extensions 36 on the spring loaded catch tabs 34. This it is due to the fact that the distance between the vertical extensions 36 in the elastically resilient spring-catching tabs 34 is minimized even before the spacing of the teeth 62 at the edge of the catch 60. Thus, the elastically deformable spring-loaded tabs 34 are deformed until to their maximum point even before the teeth 62 move away from the edges of the vertical extensions 36. This condition combined with the fact that the vertical extensions 36 (in the absence of a catch member 52) return to their undeformed dimension Xj, larger than the dimension correspondent X2 from the inside of the catch edge, allows the hearing of a " click " that occurs as soon as the vertical extensions 36 In order to unscrew the catch 52 from the finishing zone 18 once the clasp is completely assembled in the region of

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Proc. The ends 34 are to be depressed so that the vertical pressure tongue extensions 36 release the locking teeth 62 located on the inner surface of the catch edge 60. The force required for depressing the pressure tongues 34 should be large enough to hinder a child but not so strong to discourage people using medications, such as arthritics, so that they can easily depress the opposing tongues 34, while applying a force of unscrewing the catch 52. The most suitable force for the pressure tongues should be between about 0.5 and about 5 pounds (0.2265 and 2.265 g).

Further, the pressure tongues 34 should be substantially the same level as the outer surface of the ring 32 when the catch 52 has already been fully assembled to the package whereby simply grasping the ring around its total periphery should prevent the vertical extensions 36 of the pressure tabs 34 are inadvertently released from the locking teeth 62. Instead, a conscious decision to release the opposing pressure tabs has to be made by the user to initiate the opening process. This minimizes the chances of a child opening the catch 52 by pressing the entire periphery of the ring 32 in the hand while attempting to unscrew the catch 52.

To ensure that the carton 12 remains functional until all contents have been dispensed, the thickness and length of the spring loaded tabs 34 should be such that the folding pressures resulting from the initial pre-load or the deflection necessary to loosen the vertical extensions of the pressure tab 36 of the catch teeth 62 remain below the force of the polymer comprising the ring 32. The materials, such as polypropylene, have fold modules and forces which normally provide forces at the lower end of the above-mentioned scope, while materials such as acrylonitrile-15-

/ Proc. 65.251 Case: 4494BR 10 · " styrene (generally referred to as " ABS ") may be used to provide compression forces at the upper end of said force scopes.

As seen in Figure 4, the edge 44 of each pressure tongue extension 36 engages one of the locking teeth 62 to prevent the catch 52 from being unscrewed unless both spring catching tabs 34 are depressed. two surfaces are in contact so that the force applied in a direction to unscrew the catch 52 (direction of arrow 3) causes the catch tongue extensions 36 to be drawn outwardly toward the inner surface of the rim 60, less that the pressure tabs 34 have been depressed prior to the application of the force to unscrew. This allows a resistance of the package 100 to the children as it prevents a single pulling force from causing the pull tab extensions 36 to come loose from the pressure teeth 62.

As seen in Figures 2 and 3, the ring 32 has an inwardly projecting rim 38 on its upper inner surface and an inwardly projecting rim 40 on its upper inner surface. The inwardly projecting ring 40 further includes an inwardly projecting lip 41 on the lower surface. The ring 38 of the ring 32 is adapted to the recess 24 of the bottle 12 and the ring 40 with an inwardly projecting lip 41 on the outwardly projecting ring 26 of the bottle 12, as shown in Figures 2 and 3 There is a recess 42 on the opposite sides of the ring 40 of the collar 32 which corresponds with the anti-rotation screws 28 in the support zone 16 of the bottle 12 to prevent rotation of the ring 32 on the bottle 12, as already mentioned, since the ring has already been fitted to the bottle 12. The catch 52 shown in Figure 1 should have an outer edge 60 having the same diameter as the top of the cone surface 16-

Proc. The two teeth 62 projecting from the inside of the rim 60 should be 180 ° apart from each other. The teeth 62 should have smooth ramps that move the vertical extensions 36 of the pressure tabs with springs 34 inwardly when the catch 52 is screwed into the finishing zone 18 of the bottle 12, but rigid borders that engage the vertical tongue extensions of pressure 36 since the catch 52 has been fully assembled to the bottle 12, and then turned in the direction of removal. The outer edge 60 of the catch 52 should have a lower movable base edge, as seen in Figure 2, to act as a motor when the edge 60 contacts the top of the vertical extensions 36 of the spring-loaded catch lugs 34 during installation of the clasp. There is a second edge 54 of the catch 52, within the rim 60, with internal screws 56 which are complementary with the outer screws 22 in the finishing zone 18 of the bottle 12. The catch configuration with a double edge allows the use of rims relatively wide annular rings 40 projecting inwardly at the top of the ring 32. This relatively wide annular ring 40 provides a certain rigidity to the ring 32 so that it can be readily adaptable to the bottle 12. The catch 52 should be made of propylene so that there are good friction ratios between the inner locking bolts 56 and the outer polyethylene bolts 22 in the finishing zone 18 of the bottle 12. Inside the catch 52 there should be a carton or something suitable 58 which selects against the top of the finishing zone 18 of the bottle 12 when the catch 52 is installed in the bottle. Due to the variation in thickness and compressibility thereof, the location of the teeth 62 relative to the start of the internal locking bolts 56 should be such that the teeth 62 extend beyond the vertical extensions 36 of the pressure tabs with

Proc. 65.251 /

Case: springs 34, when the catch 52 is fully assembled in the bottle. This minimizes the need for tight tolerances in the corresponding parts.

The ratios of the corresponding parts of the package 100 are best seen in Figures 2 and 3, wherein the vertical transverse views of the bottle 12, ring 32 and catch 52 are in full meeting condition. The cross-section of Figure 3 is taken 90 ° from Figure 2 to better show the anti-rotation screws 28.

Mod. 71-20,000 e *. Figure 4 is a sectional view taken along section line IV-IV of Figure 2, which shows best how the teeth 62, on the edge 60 of the catch 52, engage with the vertical extensions 36 of the catch tabs spring pressure 34, once the closure has been fully installed in the bottle.

As will be appreciated by those skilled in the art, the preload of the spring loaded tabs 34 described in connection with the packaging model of Figure 1 of this invention may also be applied to many other packaging models disclosed in the U.S. patent 4,948,002 to Thorneck et al., Issued August 14, 1990, hereby incorporated by reference. The particular method for preloading the pressure tabs with elastically deformable springs 34 should be adjusted so as to accommodate the construction of that particular package. For example, in a preferred embodiment of this invention, the elastically deformable spring pressure tabs 34 are simply molded such that their upper ends project slightly behind the outer surface of the reinforcing disc 32 prior to the application of the catch 52 to the carton . The application of the catch 52 to the package causes a degree of elastic deformation of the spring loaded lugs 34, so that, in the assembled state of the package, the CA-S--.

Proc. The upper extremities of the spring loaded spring chambers 34 are substantially convenient with the outer surfaces of the reinforcing disk 32.

For models of the reinforcing disk which use a simple hanging connection between the spring pressure chambers and the reinforcing disk or the ring, the auxiliary support members used to impart in practice a spring resistance to the inner surface of the The pressure jaws may extend outwardly to a degree such as to produce a slight initial orientation towards the outside by the pressure jaws relative to the surrounding reinforcing disc prior to the application of the closure to the package. The particular method used to produce an elastically deformable spring loaded pawl configuration which serves to preload the outer surfaces of the upstanding extensions 36 against the corresponding inner surfaces of the catch edge 60 is not critical.

As already mentioned in this patent, this invention may also, if desired, be practiced until it has greater advantages with child resistant fittings of the type commonly described in US Patent 826,747, Peter W. Hamilton, Robert S. Dirksing and Reuben E. Oder of January 28, 1992 under the name CHILD RESISTANT ACCESSORY AND EASY HANDLING FOR ADULTS FOR CONTAINERS USED TO STORE POTENTIALLY HAZARDOUS MATERIALS. Child-resistant fittings of the type disclosed herein in US Patent 826,747 may be formed separately from the bottle or container used to house the drug or other potentially hazardous material, then being secured to the bottle or the container, or may be formed integrally with the bottle or container. Figure 6 shows a side view of an accessory 2100 -19- /

Proc. 65,251 Case: 4494BR is of the type normally provided in US Patent 826,747, which is incorporated herein by reference. The accessory 2100 is particularly suitable for use in conjunction with typical cylindrical pharmaceutical bottles and bottles for dispensing pharmaceuticals, such as tablets. However, the present invention may also, if desired, be practiced for use in containers having a non-cylindrical cross-section, measured perpendicular to the vertical axis of the container, for example, elliptical cross-sections, rectangular cross-sections, etc. The fixture 2100 comprises a finish zone 2001 and a closure 2002. The finish zone 2001 and the closure 2002 should be formed by injection molding of propylene, polystyrene, polycarbonate or the like. The finished zone 2001 comprises a connecting ring 2004 and a pressure ring or annular ring 2005. The annular ring shown in Figure 6 is normally cylindrical in cross-section but may, if desired, have any other transverse shape, e.g. elliptical, etc., with the cantilevered compression tongues (hereinafter described) located at the opposite ends of the major axis of the ellipse. The 2003 bill in the 2004 Link Hoop is used to handle the 2100 link to the pharmaceutical casing (not shown). The pressure ring 2005 is interrupted by grooves 2006, thus forming a pair of opposing cantilevered compression tongues 2007, as seen in Figure 7. Figure 7 is a cross-section of the connection 2100 taken through section line II of figure 6. The locking ring of the lock includes a first means for rotatably and releasably securing the catch 2002 to the finish zone 2001. In the model shown, the first means comprises helical screws 2009 on the outer surface of the screw ring 2010. The closure 2002 includes a second half-complementary means to the first means for rotatably and loosely securing the closure to the catch ring of the closure. In the model of Figure 7, the second medium

Proc. 65,251 Case: comprises screws 2018 on the inner surface of the screw ring 2017 of the closure 2002. Any suitable safety means, for example a combination of screws or screw-bolts, can be used to securely rotating or in the finishing zone 2001, the threaded bolts 2009 and 2018, respectively, as shown in figure 7, are particularly suitable.

The 2009 bolts on the outer surface of the 2010 bolt ring should be twin head bolts. The distance of the complementary screws 2009 and 2018 should be such as to provide that the closure 2002 is fully placed in the finish zone 2001 with a rotation of about 180 °. The 2005 ring, the 2010 screw ring and the 2004 connecting ring should be integrally molded, being slightly concentric with each other. The top of each spring compression flap 2007 has a vertical extension 2008 that projects above the plane of the top edge of the compression ring 2005. The vertical extensions 2008 engage with the tongues 2015 on the inner surface of the closing ring 2016 of the clasp 2002 when the closure 2002 is all screwed into the finishing zone 2001. A channel 2011, formed between the inner surface of the compression ring 2005 and the screw ring 2010, accepts the screw ring 2017 when the catch 2002 is bolted to the zone finishing work 2001.

During the closure meeting 2002 in the finishing area 2001, the tongues 2015 have to rotate over the vertical extensions 2008. However, the vertical extensions 2008 interfere with the rotation of the tongues 2015, causing the compression tongues 2007 to be deflected of form elastic for the interior. The graded main ramps on the 2015 tongues facilitate deflection. In general, it is advisable that the ramps-

Proc. The main surfaces of the vertical extensions 2008 can also be profiled as shown in the cross-sections of the vertical extensions. Figures 7A and 8A to minimize the re-application force required to fully accommodate the catch 2002 in the finish area 2001 of the ligament 2100. Both aspects help to ensure that the user properly applies the catch to restore resistance to children by the packaging after it has been opened. The continuous rotation of the closure 2002 causes the tongues 2015 to move away from the vertical extensions 2008, thereby allowing the vertical extensions 2008 and the tongues 2007 to resiliently return to the closure condition of Figures 7 and 7A. The finish zone 2001 is shaped such that the upright extensions 2008 have a maximum unrestricted outer dimension which is somewhat larger than the inner diameter of the closure ring 2016. In this case, the application of the closure 2002 to the finish zone 2001 results in the preloading of the vertical extensions 2008 against the inner surface of the locking collar 2016 when the catch 2002 is fully assembled, as shown in Figure 7A. The arrangement of the bolts 2009 and 2018 together with the vertical extensions 2008 and the bolts 2015 is such that the fastening of the bolts 2015 on the vertical extensions 2008 occurs almost simultaneously with the placing of the bolt 2002 in the finishing zone 2001, at which point the seal lip 2020 should secure the finishing filament 2025 to form a seal. This is easily obtained, since the screw 2009 is fully molded with the finish zone 2001 which includes the integrally formed compression tongues 2007, the vertical extensions 2008 and the finishing taper 2025,

Proc. 65.251 Case: 4494BR

Mod. 71 · 70,000 βκ. · 90/08 20 25 30/1 while the screw 2018 is fully formed with the catch 2002 including the tongues 2015 and the sealing lip 2020. Figure 7A is a cross-sectional view of an attachment 2100 taken along the line of section II-II in Figure 6. With the compression tongues 2007 in the position shown in Figures 7 and 7A, the borders 2030 of the vertical extensions 2008 prevent the rotation in the opposite direction of the clock hands by the tongues 2015, avoiding any attempt to reopen the attachment by rotating the catch 2002 counterclockwise, as indicated by the " T " arrow. The distance in the channel 2011 between the outer surface of the screw ring 2017 and the inner surface of the compression tabs 2007 referred to as dimension " X " in Figure 7 allows sufficient internal deflection of the compression tongues 2007 from the position shown in Figures 7 and 7A, so that the vertical extensions 2008 distances the tongues 2015 when the user depresses the tongues 2007 and applies a force of unscrewing in the direction of the " T " for the closure 2002. Figure 8 is a view of the accessory 2100 taken at a point corresponding to the section line I-I of Figure 6, but with the deflected pressure tabs 2007 inwardly. In order to unscrew the closure 2002 of the finish zone 2001 after the closure has been fully assembled, sufficient manual pressure must be applied to the opposing pressure tabs 2007 in the direction indicated by the " P " in Figure 8 so that the vertical extensions 2008 in the pressure tongues 2007 release the tongues 2015 on the inner surface of the closure ring 2016 of the closure 2002. The pressing force required to depress the tongues 2007 should be large enough to be difficult for a child, but be weak enough for people who use drugs, such as arthritics,

Proc. 65.251 Case: 4494BR 13¾¾1 10 15 g ε s

Mod. 71 20 25 allowing them to depressurize the opposing pressure tabs 2007, while applying an unscrewing force in the direction of the arrow " T " in Figure 8A for the 2002 closure. The preferred compression force " P " for the pressure tongues 2007 to provide a resistance to children without imposing extreme force for the motorically disabled adults is between about 0.5 and about 5 pounds (0.2265 and 2.265 g).

In addition, the pressure tongues 2007 should be substantially at the same level as the outer surface of the pressure ring or the ring 2005 when the closure 2002 is fully secured and in place, so that the simple grasping of the ring around the entire ring its periphery and its tightening are not sufficient to allow both vertical extensions 2008 in opposing pushing tabs 2007 to be inadvertently released from the tongues 2015 at the same time as an unscrewing force is applied at the closure 2002. Instead, the user has than to make a conscious decision to tighten the opposing pushing tongues 2007 so that the opening process begins, having this to be accompanied by a concurrent application of unscrewing force to the closure 2002 to continue. This minimizes the chances of a child being able to remove the closure 2002 by simply squeezing the entire periphery of the pressure ring 2005 while attempting to unscrew the closure 2002. Figure 8A is a cross-sectional view of a 2100 attachment taken at a point corresponding to the section line Π-Π of Figure 6, but showing the attachment 2100 in the condition shown in Figure 8, i.e., with the deflected inwardly depressed tongues 2007. The upright extensions 2008 are thus led to a position where the borders 2030 no longer prevent rotation against the clock hands of the tongues 2015 in the locking collar 2016 in the direction indicated by the " T " arrow. The user of the child restraint 2100 is then able to rotate still -24-35

Proc. 65.251 Case: 4494BR plus the 2002 zipper in a counterclockwise direction, thus causing the zipper to rise above the vertical extensions 2008 and to free the fitting of the 2009 and 2018 screws on the screw ring 2010 and screw 2017, respectively. This allows the closure 2002 to be completely removed from the finish zone 2001.

Mod. 71 · 20,000 e *. 908. Figure 9 is a partially segmented side elevation view of another alternate model 2500 of a child-resistant attachment of this invention. However, as can be seen in Figures 9 and 9A, the trim zone 2501 of a child restraint 2500 is integrally molded as a single componet with a vial 2550. The closure 2502 is shown in an unconverted fashion from an area of The pressure ring or the ring 2505 is interrupted by grooves 2506 to form the ring 2511, which accepts the screw ring 2517 of the catch 2502. a pair of pressure tongues with opposing cantilevered springs 2507. Pressure tongues 2507 have vertical extensions 2508 projecting above the plane of the upper surface of pressure ring 2505. Figure 9A shows a cross-section of a sturdy attachment to children 2500 and a vial 2550 with a catch 2502 in a condition of a full meeting - said view having been drawn through opposing pushing tongues 2507. The inf of the connecting ring 2504 is integrally molded to the uppermost end of the vial 2550. The complementary screws 2509 and 2518 of the outer surface of the screw ring 2510 and the inner surface of the screw ring 2517 respectively hold the catch 2502 in the zone The vertical extensions 2508 engage tongues 2515 on the inner surface of the closure ring 2516. As with the model of Figures 6-8A, the finishing zone 35

(I.e.

Proc. 65.251 /

Case 2504 is shaped so that the upright extensions 2508 have a maximum unrestricted outer dimension that is somewhat larger than the inner locking diameter in its ring 2516. In general, the operation of a rugged attachment children 3 2500 is similar to that described for the 2100 child resistant attachment.

It is believed that the configurations of the package, the accessory and the processes described herein, as well as the advantages referred to, are clear from these descriptions. It is clear to those skilled in the art that various changes may be made in shape, construction, and layout without departing from the scope of the invention, the claims are intended to cover all such changes within the scope of the same invention. 15

Mod. 71. 20,000 e *. - 90/08 20 25 30

Lisbon, 18 DEC 1992

By THE PROCTER & GAMBLE COMPANY

1, 2, 3, 4, 5, 6, 7, 8

Claims (3)

Proc. The apparatus of claim 1, Suitable packaging for the storage and distribution of potentially hazardous material, said child-resistant but easy-to-open packaging for adults, characterized in that it comprises: (a) a bottle for containing said potentially hazardous material, said bottle having a base zone and a finishing zone; (b) a first means for releasably securing said closure area of said bottle, said first medium being secured in a fixed relationship about the periphery of said finishing zone; (c) a ring secure with respect to said base zone of said bottle, said ring including at least one elastically deformable compression tab having a vertical extent projecting on the outer surface of said ring, which compression tab upper end, moves inwardly relative to the remainder of said ring, whenever a pressure force is applied to said upper end of said compression tab; and (d) a catch having at least one rim and including a second means for cooperating with said first means for releasably and releasably securing said catch to said bottle, said shaft having at least one locking tooth on the surface interior of said edge, said locking tooth being shaped and positioned so as to flex said vertical extent of said elastically deformable compression tab, when said catch is rotatably secured in said area of said locking tooth, Mod. 71-20,000 e. - 90/08 20 25 30 Proc. 65.251 Case: 4494BR cv finishing said bottle but avoiding the removal of said closure from said finishing zone by rotating said closure in the reverse direction unless said elastic deformable compression tab in said ring is first depressed to release said vertical extent of tab of the locking tooth, said elastic deformable compression tab having an undeformed configuration which will cause interference between the inner surface of said closure edge and the outer surface of said vertical extension on said compression tab whenever the closure is fully secured in said finishing area of said container, whereby said compression tab is elastically deformed to at least one degree, when said catch is fully secured in said finishing area of said container so that said vertical extent of said compression tab exerts a preload force c on the inner surface of said closure edge. A packaging suitable for storage and distribution of potentially hazardous material, said packaging being child-resistant but easy to open by adults, characterized in that it comprises: (a) a bottle for containing said potentially hazardous material, said container bottle a base zone and a finishing zone; (b) a first means for releasably securing a closure to said finish zone of said bottle, said first means being secured in fixed relation about the periphery of said finishing zone, said base zone and said zone which are connected to one another by a support zone, converging in the direction 28 '35'. uc .1139 * 1 5 10 15 Proc. 65.251 Case: 4494BR Mod. 71 · 20,000 ex. 90 08 25 of said finishing zone; (c) a ring secure with respect to said abutment zone of said bottle, said ring including at least one elastically deformable compression tab having a vertical extent projecting above the upper surface of said ring, the upper end of said compression tab inwardly relative to the remainder of said ring, when a compressive force is applied to said upper end of said compression tab; and (d) a closure having at least one edge and including a second means for cooperating with said first means for releasably securing said closure to said bottle, said closure having at least one locking tooth on the inner surface of said closure said locking tooth having a shape and a position such that it will deflect said vertical extension of said elastically deformable compression tab when said catch is advanced into said finishing zone of said bottle, preventing the removal of said catch of the finishing zone of said bottle unless said elastically deformable compression tab in said ring is first depressed to release said vertical extent of the compression tab of said locking tooth, said elastic deformable compression tab having a non-adjustable configuration which will cause interference between the inner surface of said closure edge and the outer surface of said vertical extension in said compression tab, when said catch is completely secured in said finishing area of said container, by means of which said compression tab is elastically deformed, at least up to a degree, when said catch said closure is fully closed. 65.251 Case: 4494BR I .1% 5, 15 is secured in said finishing zone of said container so that said vertical extent of said compression tab exerts a preloading force against the inner surface of said catch edge. A packaging suitable for the distribution of potentially hazardous matter, such as a tablet or an amphetamines medicament, said child-resistant but easy-to-open adult packaging is characterized in that it comprises: (a) a bottle for containing said medicament in the form of tablets, said bottle having a base zone; (b) a first means for releasably securing a closure to said finishing zone of said bottle, said first means being secured in a fixed relationship about the periphery of said finishing zone, said base zone and said zone end zone interconnected to one another by a support zone converging towards said finishing zone; (C) a ring securely secured to said support zone of said bottle, said ring including a pair of resiliently deformable spring-type compression lugs located about 180Â ° from each other at the periphery of said ring, each of the spring type compression lugs elastically deformable by a vertical extent projecting above the upper surface of said ring, the upper ends of said compression lugs moving inwardly relative to the remainder of said ring, when compression forces are applied to said upper ends of said compression lugs; and 35 1 5 10 15 Proc. (D) a closure having at least one edge, including a second means, for cooperating with said first means for releasably securing said closure to said first closure means; said closure teeth having a shape and being in a position such that they will deflect said vertical extensions of the said teeth, said locking teeth having a shape and being in a position such that they will deflect said vertical extensions of the said teeth; said elastically deformable spring-type compression tabs when said closure is advanced into said finish zone of said bottle, preventing removal of said closure from said neck region of said bottle, unless said compression tabs of the elastically deformable spring members are first depressed to release said vertical extensions of said compression tab from said locking tooth, said compression lugs being deformable elastically an undeformed configuration interfering between the inner surface of said closure edge and the outer surface of said upstanding extensions in said compression tabs whenever the closure is fully secured in said finishing zone of said container, whereby said compression lugs are elastically deformed at least to a degree when said catch is fully secured in said finishing zone of said container such that said upstanding extensions in said compression lugs exert a force of the pre-load against the interior surfaces of said catch edge. A child-resistant accessory for a container suitable for storage and distribution of potentially hazardous material, said child-resistant but adult-opening aperture is characterized in that it comprises: 15 Mod. 71 20,000 e «. · 90/08 20 25 30 Proc. (A) a finishing zone with a locking safety ring including a first means for securing a releasably lockable closure to said locking safety ring, on at least one of its surfaces, a means for securing said finishing zone to said container, and an annular ring, aligned generally concentric with said locking safety ring, interrupted by at least one pair of slots, thereby forming at least one compression tab in an elastically deformable balance having an exposed surface contour that normally engages the outer surface contour of the adjacent zones of said annular ring to minimize the chances of an inadequate depression when grasping said annular ring, said tab a vertical extension extending above the upper surface of said annular ring, said compression lug moving at its upper end inwardly (b) a closure having a first edge including at least on one of its surfaces a second medium complementary to said first means for rotatably and releasably securing said closure to said locking safety ring in said finishing zone and a second edge external to said first edge, said lock also having at least one locking claw on the inner surface of said second said locking claw being formed and being positioned so as to deflect said vertical extent of said elastically deformable compression tab when said catch is rotatably secured to said latching member; : t Proc. The finishing zone, preventing the withdrawal of said closure from said finishing zone by rotating said closure in the reverse direction, unless said elastically deformable swing compression tab in said annular ring is first depressed to releasing said vertical extent of the compression tab of said locking claw, said elastically deformable swinging compression tab having an undeformed configuration which will interfere between the inner surface of said secondary closure edge and the outer surface of said vertical extension , when said closure is fully secured in the finishing zone of said container. Mod. 5. A child-resistant accessory according to claim 4, characterized in that said securing means for securing said finishing area of said container comprises an accessory ring including a corresponding security means in said container in order to resist to the separation of said child resistant attachment from said container, in particular by children, since said child resistant attachment is fully assembled in said container. A child-resistant accessory according to claim 5, characterized in that said safety means enables an unlimited 360 ° rotation of said child-resistant accessory relative to said container about a vertical axis passing through the center of said child resistant attachment, while maintaining said finishing zone securely secured to said container. The child resistant article according to claim 4, characterized in that said finishing area of said child-resistant attachment is permanently attached to a child's clothing. - 30/06 20 25 30 Proc. The container is secured to said container. A child-resistant accessory according to claim 7, characterized in that said finishing area of said child resistant attachment is permanently secured to said container because it is integrally molded at that time. A child-resistant accessory according to claim 4, characterized in that said first and second means for releasably and releasably securing said closure to the catch safety ring comprises thread threads wherein said annular ring includes two pairs of grooves, thereby forming a pair of resiliently deformable compression lugs with vertical extensions and wherein said closure includes a pair of opposing locking jaws. The child-resistant attachment of claim 9, characterized in that the compression force required to depress said resiliently oppositely deformable compression lugs to a distance sufficient to release said vertical extensions from said locking claws, is within the range from about 0.225 g to about 2.25 g (0.5 pounds and about 5 pounds). 11. The structure of claim 1, 2, 3 or 4, characterized by said preloading force exerted by the vertical extension of each of the elastically oppositely deformable compression lugs against the inner surface of said catch edge being from about 0.0045 g to about 0.9 g (0.01 pound and 2 pounds). A structure as claimed in claim 1, 2, 3 or 4, characterized in that each of the compression lugs elastically deformable in said ring is joined to said ring at its lower end through a connection in the groove. 65.251 Case: 4494BR r > Whereby each of said elastically deformable compression lugs resists said compression force applied at its upper end, acting as a beam spring through its swinging connection with the remainder of said ring. The structure of claim 1, 2, 3 or 4, characterized in that said first and second means for releasably securing said catch in said finishing zone of said bottle comprises complementary threads. A structure according to claim 1, 2 or 3, characterized in that said ring is secured to said bottle by means of at least one hook in said bottle or in said ring and at least one complementary ring, on the other side , of said bottle or said ring. The structure of claim 14, further including at least one anti-rotation aza in said bottle and a complementary recess in the region of attachment of said ring, whereby said ring is prevented from rotating with respect to said ring bottle when a torsional force is applied to said closure without first depressing each of the elastically deformable compression tabs to release each of the vertical extensions of the locking tooth compression tab at the edge of said closure. A structure according to claim 1, 2, 3 or 4, characterized in that said locking tooth on the inner surface of the edge of said catch has a gradually decreasing spindle-shaped surface which gradually deflects the vertical extension of said elastically deformable compression tab, when said closure is advanced to said finish zone of the elastic deformable compression tab, Proc. Said abutment will allow said vertical extension to yield backward towards its undeformed condition immediately after the passage of the locking tooth behind said vertical extent of said compression tab, wherein it is provided to the user an auditory signal that the packaging is in child-resistant condition until the next use and distribution period. The structure of claim 16, wherein said upright extension of said elastically deformable compression tab and said locking tooth at the edge of said closure have attachment surfaces that tend to lock more closely said tooth and said tooth said vertical extension with one another if a torsional force is applied to said closure without first depressing the upper end of said compression tab. Structure according to claim 1, 2 or 3, characterized in that said locking edge containing said locking tooth comprises an outer edge. Lisbon, Portugal. By THE PROCTER & GAMBLE COMPANY - - - - - - - - - - - -