EP0098883A1

EP0098883A1 - Safety cap for container particularly for medicines

Info

Publication number: EP0098883A1
Application number: EP19830900820
Authority: EP
Inventors: Marcelo Chiquiar-Arias
Original assignee: Merctech Inc
Current assignee: Merctech Inc
Priority date: 1982-01-19
Filing date: 1983-01-19
Publication date: 1984-01-25
Also published as: MX157606A; WO1983002436A1

Abstract

Un capuchon de sécurité (10) pour un conteneur (30) possède des dents (13) entre un organe de base scellé sur le conteneur ou des dents scellées sur le conteneur, ces dents étant fixées à leurs extrémités extérieures à un organe de capuchon et ayant une longueur suffisante pour montrer que l'organe de capuchon, lequel ferme le conteneur lui-même ou sert de capuchon protecteur, sous la forme d'un anneau, a été enlevé, indiquant ainsi au client que le contenu a été adultéré, en particulier dans le cas de médicaments. L'invention concerne également un ajutage à deux étages pour influencer le client à saisir l'ajutage d'un conteneur suivant une relation d'espacement par rapport à une ouverture de distribution, laquelle ouverture, dans un mode préférentiel de réalisation, peut être fermée par le capuchon de sécurité de l'invention.A safety cap (10) for a container (30) has teeth (13) between a base member sealed on the container or teeth sealed on the container, these teeth being fixed at their outer ends to a cap member and of sufficient length to show that the cap member, which closes the container itself or serves as a protective cap, in the form of a ring, has been removed, thereby indicating to the customer that the contents have been adulterated, by especially in the case of drugs. The invention also relates to a two-stage nozzle for influencing the customer to grasp the nozzle of a container according to a spacing relation with respect to a dispensing opening, which opening, in a preferred embodiment, can be closed by the safety cap of the invention.

Description

SAFETY CAP FOR CONTAINER PARTICULARLY FOR MEDICINES

FIELD OF THE INVENTION The present invention deals with safety caps for use with disposable plastic containers, particularly those containing medicines,, so as to make it self-evident whether the containers have been previously opened, particularly in connection with containers for medicines. BACKGROUND OF THE INVENTION In recent times it has become important to ensure that the consumer be made aware of any possible tampering with a container for medicines from the time said container has left the factory. It is desired that it should be self-evident if the container has been opened and the contents interfered with.

Also, for a certain time, various types of contaxners for unitary use have been developed, which have not been totally effective in insuring that the liquid contents of such a container be kept in substantially sterile condition and such contents maintained in sterile condition at the time of dispensing the liquid medicament, such as in the case of eye drops dispensed from the nozzle of a one-time container or any container in which the nozzle of the container is held in one hand and it is desired to keep the fingers of [the user away from the opening in the nozzle dispensing the liquid content of the container. U.S. Patents 3,777,949 and 4,358,028 of the present applicant and U.S. Patent 4,134,511 of Deussen are typical of prior art in this connection. Caps for various types of containers, including soft drink bottles, have been known in which a screw type metal cap is attached to a base member with a perforated section separating the screw cap, riding on the threads of the neck of the bottle, from the base member which is fitted in the neck of the bottle. The rotation of the screw cap in the threads of the bottle causes it to be moved axially of the neck of the bottle to force it away from the base member which is free to rotate on the neck of the bottle but cannot move axially outwardly because of an intervening rim on the neck of the bottle. The portion of the cap between the perforations finally breaks away and the cap can be finally unscrewed to permit dispensing the contents of the bottle and the cap returned by re-screwing it on the threads of the bottle. In general it is not possible to determine readily whether the bottle has been opened by mere visual inspection of the cap since the perforations are. usually quite tiny and are not intended for inspection purposes, as the base member can be pushed back up and rejoined to the cap with an adhesive or the like without being readily evident to the user. OBJECTS OF THE INVENTION

It is an object of the present invention to provide a safety cap for a container to make it self evident when the container has been opened.

It is a further object of the invention to provide a container for dispensing liquid medicines having a nozzle portion adapted to be held by the fingers of one hand while preventing said fingers from accidentally contacting the contents dispensed from the opening in said nozzle. SUMMARY OF THE INVENTION

In accordance with the present invention there is provided a safety cap for a container, said container having an opening for dispensing the contents therefrom, said safety cap including a base member for permanently affixing to the container about said opening, an outer cap member positioned to encompass said opening, and a plurality of spaced teeth connecting said cap member and said base member, the base member and the cap member having opposing surfaces lying between said teeth, said opposing surfaces being sufficiently spaced from each other so that one can readily determine by visual inspection whether any of the teeth extending between said surfaces have been broken. The invention also comprises said safety cap in combination with the container having the dispensing opening therein, said base member either being sealed to the container about its dispensing opening or being a portion of the container itself. In particular, there is provided the combination of a container with a safety cap, said container having an opening for dispensing the contents therefrom, said safety cap comprising an outer cap member positioned to encompass and be spaced from said opening and a plurality of spaced teeth connecting said cap member to said container in spaced relationship to and about said opening, said cap member extending about an axis which passes through said opening, said cap member having surfaces extending transversely of said axis and between said teeth and spaced from said container a sufficient distance so that one can readily determine by visual inspection whether any of the teeth extending between the container and said surfaces have been broken.

The invention also concerns a container of molded plastic to be manually opened for dispensing liquid medicines and the like, said container being molded as an integral piece so that its several parts disposed along a central longitudinal axis of the container are of sequentially narrower widths, said sequential parts consisting of: a wide flexible body adapted to be compressed for expelling the contents of the container; a first relatively rigid nozzle portion having substantially parallel sides with a cross-section having a diameter less than the diameter of the flexible body; a second relatively rigid nozzle portion with a cross-section having a diameter less than that of the first nozzle portion, and means for sealing a dispensing opening in said second nozzle portion; at least said wide flexible body and said first and second nozzle portions defining therein a hollow cavity for the liquid to be dispensed from said dispensing opening, said first nozzle portion being immediately adjacent said second nozzle portion so as to form an abrupt step, said first nozzle portion being designed to be gripped by the fingers of the hand, said second nozzle portion having sufficient axial length to space the fingers of the hand grasping the first nozzle portion a sufficient distance from said opening so as to substantially eliminate the possibility of contamination of the contents of the orifice by fingers holding the first nozzle portion, said second nozzle portion having insufficient dimensions to permit ready holding by the fingers for supporting said container when removing the means for stopping the dispensing opening. BRIEF DESCRIPTION OF THE DRAWINGS The invention will now be described with reference to the accompanying drawings illustrating specific embodiments of the invention in which:

Figure 1 is a longitudinal cross-section, partially broken away, of an embodiment of a container of the invention to be opened by twisting the breakable tip and Figure 1A is an end view of the same container.

Figure 2 is a similar longitudinal cross section, and Figures 2A and 2B, two end views, of respective embodiments of a container with non-slip and grooved projections on the first wider nozzle portion, wherein Figure 2A shows such a first nozzle portion to be opened with the fingers and 2B shows a first nozzle portion to be opened with safety caps of the present invention.

Figure 3 shows some forms of breakable tips of the containers of the invention with non-slippage or safety-cap engaging designs.

Figure 4 shows a longitudinal cross-section of the front end of the container in Figure 1 combined with an embodiment of a cap of the present invention, also shown in longitudinal cross-section; Figure 4A is an internal view of the safety cap opener; and Figure 4B is a side-external view of the cap placed on the container.

Figure 5 shows an external side view of another safety self-opener cap placed on the container of Fxgure 2 showing how the cap projections are engaged with the container nozzle while Figure 5A shows a reversible cap and the relative positioning of the means on the interior of the safety cap with the breakable tip of the container.

Figure 6 is a longitudinal cross-section of another safety cap placed on a container with an orifice for expelling the contents thereof, and Figure 6A shows a side external view of the cap.

Figure 7A shows a side view o f another safety cap with breakable teeth with a separate base portion and cap portion of the safety cap, wherein Figure 7B shows said end cap broken away from said base member.

Figure 8 shows in cross-section an embodiment of the invention wherein the cap of Figure 7 is used as an overcap in position to prevent opening of an underlying screw cap without first breaking the teeth of said overcap, whose base portion is bonded to the container; wherein Figure 8A shows an end view of the overcap having a solid end portion whereas Figure 8B shows another overcap in cross section in the form of an annular ring which lies on the sides of the screw cap and is affixed thereto and is connected by the teeth to another annular ring sealed or otherwise affixed to the container. Figure 9 shows an external side view, and Fxgure 9A shows an end view, of an embodiment of the invention similar to that of Figure 8B in which the overcap is in the form of an annular ring which lies on the end wall (top) of the screw cap. SPECIFIC DESCRIPTION

Figure 1 shows the sealed bottom (1) of a container (30) after having been filled with its contents (3). The container (30) includes a relatively rigid first nozzle portion (4) having substantially parallel sides with a cross-section having a given diameter and a second nozzle portion (6) , which is also relatively rigid and has substantially parallel sides with a crosssection having a diameter less than the diameter of the first nozzle portion, and also a breakable tip (5) serving as means to seal the orifice (8), which is formed on twisting the tip (5) about its axis and causing the breakable section (7) to rupture so as to expell the contents (3). The shoulder (3A) connect.ing the flexible body portion (2) of the wider diameter than the first nozzle portion (4). In the preferred embodiment shown in Figures 2, 2A and 2B, the first nozzle portion (4) has projections (16), which are either in the form of axially extending ridges (16') adapted to be grasped more readily by the fingers of one hand or radially extending projection (16''), which are adapted to mesh with the teeth of a safety cap, also acting as an opener.

Figures 4 and 4A show the combination of the safety cap (10) of the invention adhered to the container at the nozzle portion by teeth (13) having a reduced thickness radially of the axis of the container at region (14). The length of said teeth (13) extending in a direction of the axis of the container passing through the opening of the container in combination with the spacers (15) between said teeth are such as to make it evident to the user if said teeth have been broken so as to gain access to -the dispensing opening of the con tainer. In the case of Figure 4B, the breakable tip (5) is positioned within the safety cap (10) so that upon rotation of said safety cap, both the teeth (13) are broken as well as tip (5) twisted so as to cause the formation of the dispensing opening (8). Non-slip longitudinal xidges (11) are on the outside of the safety cap to assist its rotation about its axis. Fxgure 4A shows the configuration on the interior of the cap (10), its socket (22) conforming to the fourth embodiment of the tip (5) shown in Figure 3. The breaking of teeth (13) would show that the tip has also been broken.

Figure 5 shows the teeth (16) connected to the shoulder portion (3A) of the container as shown in Figure 1 in which the teeth are directly sealed to said shoulder. In Figure 7A teeth (18) are sealed to a separate annular base member (17), which is sealed to a container (30). In the embodiment of Figure 7A the neck of the container and its means for closing its dispensing opening, for example a friction-fit stopper or a screw cap, are not shown. However, the overcap (10) by virtue of its connection to the base member (17) by teeth (18) enables one to see whether the overcap has been removed so as to permit access to the screw cap or other closing means. Figure 6 shows a safety cap (10''') adhered to the nozzle portion (23) of a container by means of teeth (13), which have narrower widths as shown in Figure 6A. The safety cap (10' ' ' ) also serves to stop the dispensing opening of the container by means of a closing projection (21), which is conically shaped and is designed to extend into the circular opening of the nozzle (23).

The embodiment of Figure 5A shows the possibility of a safety cap, which can be reversed after it has been broken. Breakable teeth (13) affixed the cap to the con- tainer, said cap having longitudinal ridges (11). A hollow cavity (22) in the cap engages the breakable tip of the container. After the tip is broken, the cap can be reversed so that the resulting opened orifice of the container can be covered by the external skirt of the cap and plugged with the inner projection (21) of the cap. Figure 8 shows a container (40), a screw cap

(42), a base member (44) and an overcap (46) with its solid end (48) with teeth (50) equally spaced so as to join the overcap (46) to the base member (44). Figure 8B shows in cross-section an overcap in the form of an annular ring (52) which has an inside diameter appropriate to snuggly fit over the sides of the screw cap (42) and which is connected to the base member (44) which is also in the form of an annular ring, by the teeth (50). The ring (52) is affixed to the screw cap (42), both of which are preferably of a suitable plastic, e.g., polypropylene, by ultrasonics, by a suitable adhesive or by pressure-fitting.

Figures 9 and 9A show an overcap in the form of an annular ring (56), which has an inside diameter less than the outside diameter of the head of the screw cap (42) and which is connected to the base member (44), also in the form of an annular ring, by the teeth (54). Either arrangement (Fig. 8 or 9) has the advantage in that the annular ring (52) or (56) can fit on various sized caps and can be adhered to various containers already in use, that is, without requiring modifications of the existing caps and plastic containers now in use. In this connection both the plastic of the container and the plastic of the base member (44) are of mutually sealable materials, which can be sealed together by means of heat, for example ultrasonics. This overcap can be used to cover various types of closing means, either the breakable tip (5) or the screw cap (42). The teeth connecting the safety cap to the container must be sealed thereon or must be sealed to a base member, which is in turn sealed to the container. Similar base members of caps opened by twisting according to the prior art, such as with soft drinks, were not sealed to the bottle but could rotate freely on the bottle. Having the base member rotate and move freely with respect to the bottle would be undesirable because it could be carefully repositioned and rejoined by sealing means to the cap to look non-tampered, lacking the long teeth of instant application.

It will be noted from Figure 7B that the teeth (181 have been broken at points (19) by virtue of the twisting.

The teeth (13) and (18) vary in length between about one millimeter and one centimeter and are usually 2-4 mm, usually about 3 mm. in length. The teeth (50) of the overcap of Figure 8, including the embodiments of either Figures 8A or Figure 8B, can be up to 2 cm. in length but are preferably 2-6 mm. in length. There should be at least two such teeth, usually 3-12, and preferably 4-6. Said teeth usually have a width (as seen transversely to the axis of the container) which axis passes through the opening of the container and is parallel to the walls of the container, of 1 mm. - 3 mm. The ratio of the diameter of the safety cap to the axial length of the space between the surface (51) of the overcap between the teeth (18) and the points of attachment to the container as designated by reference numeral (9) in

Figure 5 is usually about 6:1. The general ratio of the diameter of the overcap to the distance between surface (511 and the point of attachment of the teeth (18) to either the base member (17) or the container (30) itself, and to the width of the teeth (18) is usually in the ratio of about 12:2:1.

It can be seen from Figure 1 that the first nozzle portion (4) is readily gripped with the fingers but that nozzle portion (6) is of insufficient axial length to permit ready grasping by the fingers. Therefore, the fingers are forced to grasp the larger diameter portion (4) so that the fingers are automatically spaced from the breakable portion (7), which forms the orifice (8) on breaking of tip portion (5). The first nozzle portion (4) and the second nozzle portion (6) can be prismatic or cylindrical in shape but in any event have substantially parallel sides. The step between said nozzle portions discourages the fingers grasping the first nozzle portion (4) from advancing much beyond the step portion. The first nozzle portion (4) usually has a length of between 5 mm. and 2.0 cm. and is preferably 1 cm. in length.

The containers of the invention, such as shown in Figures 1-7, are generally made by an injection and/or blow molding system with the end opposite the nozzle portion open to be sealed in a sealed portion (1) as in Figure 1. The safety caps (10) are manufactured with a mold and are designed to be more rigid than the container (30).

To facilitate the observation as to whether the safety cap has been rotated or not, it is preferable that the container and the cap, including the teeth, have different colors. For example, one element could be in the natural color of the plastic and the other in any other contrasting color, by which arrangement one could readily see whether the cap had been rotated by virtue of not seeing its broken projections continuous.

The overcap of the invention can also be designed so that an annular ring which acts as the base member can be slid up and down the axially extending side walls of the container so as to be bonded to said walls at the correct position for maintaining the teeth connecting the base member to the cap member at the appropriate tension for making it necessary that the breaking of at least one tooth, usually at least one half the teeth, and preferably all of the teeth, takes place before the closing means can be removed from the dispensing opening of the container.

The embodiment with two annular rings can be applied to several size containers and caps of the same diameter each instead of having to make one overcap for each size container and cap, as it is not critical whether the annular rings cover all or part of the cap or whether they are centered. In this way one reduces the number of necessary overcap sizes.

Claims

C L A I M S

1. A safety cap for a container, said container having an opening for dispensing the contents therefrom, said safety cap including a base member for permanently affixing to the container about said opening, an outer cap member positioned to encompass said opening, and a plurality of spaced teeth connecting said cap member and said base member, the base member and the cap member having opposing surfaces lying between said teeth, said opposing surfaces being sufficiently spaced from each other so that one can readily determine by visual inspection whether any of the teeth extending between said surfaces have been broken.

2. A safety cap according to claim 1, in which the cap member and base member extend about an axis which also passes through the opening of the container, the teeth between the base member and the cap member having a width transversely of said axis of dimensions to permit ready breaking of said teeth by twisting the cap relative to the base member about said axis.

3. A safety cap according to claim 1, in which the teeth have reduced thickness radially of said axis.

4. A safety cap according to claim 1, which includes means on the interior of the outer cap member for sealing said dispensing opening.

5. A safety cap according to claim 1, in combination with a container having a dispensing opening therein, the base member being sealed to the container about its dispensing opening.

6. The combination according to claim 5, in which the base member is a portion of the container itself.

7. The combination according to claim 5, in which the base member is of a plastic material sealable to the material of the container, and the plastic base member is sealed to the container.

8. The combination according to claim 5, in which the container includes closing means for closing the dispensing opening.

9. The combination according to claim 8, in which the closing means is a screw cap.

10. The combination according to claim 8, in which the closing means is frictionally fitted in the dispensing opening.

11. The combination according to claim 8, in which the cap member is an overcap which is connected to the base member, said cap member contacting the closing means.

12. The combination of a container with a safety cap, said container having an opening for dispensing the contents therefrom, said safety cap comprising an outer cap member positioned to encompass said opening and a plurality of spaced teeth connecting said cap member of said container in spaced relationship to and about said opening, said cap member extending about an axis which passes through said opening, said cap member having surfaces extending transversely of said axis and between said teeth and spaced from said container a sufficient distance so that one can readily determine by visual inspection whether any of the teeth extending between the container and said surfaces have been broken.

13. - The combination according to claim 12, which includes closing means for closing the dispensing opening and in which the cap member is an overcap which contacts the closing means, said teeth holding said cap member in position over said closing means so as to prevent the opening of the closing means until at least one of said teeth is broken.

14. The combination according to claim 13, in which the teeth prevent opening of the closing means until all of the teeth have been broken.

15. . The combination according to claim 13, in which the closing means is a screw cap.

16. The combination according to claim 13, in which the closing means is a breakable solid tip sealing the dispensing opening.

17. A contaxner of molded plastic to be manually opened for dispensing liquid medicines and the like, said contaxner being molded as an integral piece so that its several parts disposed along a central longitudinal axis of the container are of sequentially narrower widths, said sequential parts consisting of: a wide flexible body adapted to be compressed for expelling the contents of the container; a first relatively rigid nozzle portion having substantially parallel sides with a cross-section having a diameter less than the diameter of the flexible body; a second relatively rigid nozzle portion with a cross-section having a diameter less than that of the first nozzle portion, and means for sealing a dispensing opening in said second nozzle portion; at. least said wide flexible body and said first and second nozzle portions defining therein a hollow cavity for the liquid to be dispensed from said dispensing opening, said first nozzle portion being immediately adjacent said second nozzle portion so as to form an abrupt step, said first nozzle portion being designed to be gripped by the fingers of the hand, said second nozzle portion having sufficient axial length to space the fingers of the hand grasping the first nozzle portion a sufficient distance from said opening so as to substantially eliminate the possibility of contamination of the contents of the orifice by fingers holding the first nozzle portion, said second nozzle portion having insufficient dimensions to permit ready holding by the fingers for supporting said container when removing the means for stopping the dispensing opening.

18. A container according to claim 17, in which the means for sealing the dispensing opening from the container comprises a breakable solid tip portion adapted to be broken off from the second relatively rigid nozzle portion.

19. A contaxner according to claim 17, in which the means for sealing the opening of the container is adapted to be frictionally fitted in said opening.

20. A container according to claim 18, which includes a safety cap for the container, said safety cap having interengaging means in the interior portion of said safety cap to grasp the tip portion so as to effectuate the movement of the tip to break open the orifice.

21. A container according to claim 17, in which the first and second nozzle portions are of cylindrical shape.

22. The combination according to claim 13, in which the overcap is in the form of an annular ring having a smaller internal diameter than the outer diameter of the closing means so as to snuggly fit over the latter.

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