WO1997010155A1

WO1997010155A1 - Tamper-evident container

Info

Publication number: WO1997010155A1
Application number: PCT/US1996/014479
Authority: WO
Inventors: Egon Erlich
Original assignee: Egon Erlich
Priority date: 1995-09-15
Filing date: 1996-09-10
Publication date: 1997-03-20
Also published as: AU7237696A

Abstract

A tamper-proof container (10) includes a break off neck extension (16) which is sealed to provide a blind end. A closely fit plug (30) is inserted and retained by a lip (32) and groove (34) structure on the mating surfaces of the neck extension (16) and the plug (30). The plug (30) may have a ledge (36) that interacts with a shoulder (38) on the neck extension (16) and/or the top end of the neck extension and plug may be heat-sealed together. A cap (22) is carried by the neck extension (16) prior to breaking of the neck extension (16) at the score line (18), and then is used to close the container (10).

Description

TAMPER-EVIDENT CONTAINER

Cross-Reference to Related Applications

This application claims the benefit of U. S. Provisional Application No. 60/003,804 filed September 15, 1995.

Field of the Invention

This invention relates generally to tamper-evident containers with frangible seals of the type intended to disburse substances such as medication.

Background of the Invention

A tamper-evident container is one having an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred. Requirements are set forth in Food and Drug Administration Compliance Policy Guide 7132a.17 entitled "Tamper-Evident Packaging Requirements for Certain Over-The Counter (OTC) Human Drug Products," wherein 12 technologies have been considered acceptable, listed as follows: (1) film wrappers, (2) blister or strip packs, (3) bubble packs, (4) heat shrink bands or wrappers, (5) foil, paper or plastic pouches, (6) bottle mouth inner seals, (7) tape seals, (8) breakable caps, (9) sealed metal tubes or plastic blind end heat-sealed tubes, (10) sealed cartons, (11) aerosol containers, and (12) cans (both all-metal and composite). Specific details are given for each of the foregoing technologies. For "breakable caps" the guideline requires that the container be sealed by a plastic or metal cap that either breaks away completely when removed from the container or leaves part of the cap attached to the container, but in any event the cap cannot be reapplied in its original state. With "sealed metal tubes or plastic blind-and heat-sealed tubes, the mouth or blind-end must be punctured to dispense the product.

There have been a wide variety of containers formed to resist or reveal tampering, some of which incorporate frangible or breakable seals wherein one cannot open the container without visibly altering the appearance of the container. See for example U. S. Patent No. 4,743,548 entitled "Tamper-Evident Container with Frangible Seal" by H. Deussen, U. S. Patent No. 4,852,751 entitled "Tamper Indicating Container- Closure Package" by J. W. Halfacre, U. S. Patent No. 4,688,703 entitled "Tube-Shaped Container" by M. Bayer, U. S. Patent No. 5,255,804 entitled "Tube of Tamperproof Construction and Process for Making Same" by G. Butterbrodt. The complexity of the mechanisms utilized for attempting to secure a tamper- evident dispenser for medications and the like makes such containers very expensive. It is critically important that the closed structure be impenetrable, that is, not allow any penetration whether by opening or by insertion of a needle, or the like, without such penetration being evident either by a destruction of the closure or by readily apparent visible marring.

SUMMARY OF THE INVENTION

The present invention meets the foregoing needs in providing a tamper-evident container. The container includes a break off neck extension which is sealed to provide a blind end, for example with a closely fit plug inserted and retained by a lip and groove structure on mating surfaces of the neck extension and plug. The top end of the extension and plug can be heat sealed. A cap is carried by the neck extension before break off but is not destroyed. Rather it is intended to be removed from the neck extension and secured to the neck after break off to close the container.

More specifically, a tamper-evident container is provided in which a neck on the container body defines an outlet opening and is connected by a frangible region to a break off neck extension. A plug is closely fitted within the neck extension so as to lie entirely within the neck extension and is retained permanently within the neck extension. Permanent retention can be accomplished by heat sealing the plug to the neck extension. The plug can be locked in place by providing corresponding lip and groove structures on mating surfaces of the plug and neck extension., interrupt any attempt to directly insert a needle, or the like, into the container.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a side sectional view of one embodiment of the invention shown before break off of the neck extension and showing a closure cap threaded onto the top of the neck extension;

Figure 2 is a side sectional view of the embodiment of Figure 1 after break off of the neck extension and placement of the cap directly onto the dispensing opening of the container;

Figure 3 is a side sectional view of a second embodiment of the invention in which the neck extension is formed to receive a plug;

Figure 4 is a side elevational view of a plug formed to be inserted into the neck extension of the embodiment of Figure 3; Figure 5 is a side sectional view of the neck, neck extension, and plug of the embodiment of Figure 3;

Figure 6 is a side sectional view of a third embodiment of the invention in which the neck extension is formed to receive a plug;

Figure 7 is a side elevational view of a plug formed to be inserted into the neck extension of the embodiment of Figure 6;

Figure 8 is a side sectional view of the neck, neck extension, and plug of the embodiment of Figure 6;

DETAILED DESCRIPTION One embodiment of a tamper-evident container 10 is shown in Figures 1 and

2 to illustrate generally one aspect of the invention. The container 10 includes a neck 12 which provides an outlet opening 14 for the product, and a neck extension 16 which is generally of the same outer dimension as the neck 12. The bottom of the neck extension 16 is open and is integral with the top of d e neck 12 so as to communicate directly with the outlet opening 14. A score line 18 defines the boundary between the neck extension 16 and the neck 12 and defines a frangible region connecting the neck extension 16 and neck 12. The scoreline 18 makes the connection between the neck extension 16 and neck 12 sufficiently frangible so that the neck extension is readily broken away from the neck, simply by twisting, by pivotal motion or by cutting with a sharp object. The top end 20 of the neck extension is shown as being open, but in actuality means are applied to seal the top end of the neck extension. In accordance with the generality of the invention, any sealing means can be used. A plug as will be described hereinafter is one form of sealing means but an inner seal of paper, thermoplastic, polystyrene foam, plastic film, foil or any combination thereof can be applied across the otherwise open top end 20 of the neck extension 16 so as to seal it in such manner that the seal must be torn or broken to open the container and remove the product. See in this regard the reference to "bottle mouth inner seals" in Food and Drug Administration Compliance Policy Guide 7132a.17. A particular means of sealing will be described below involving the use of a plug, but Figures 1 and 2 illustrate the general use of a cap 22 which is formed with intemal threads 24 mating with extemal threads 26 on the neck extension 16 adjacent the top end 20. The neck 12 is also formed with extemal threads 28 at a region adjacent the outlet opening 14 just below the scoreline 18. Any other cap retention mechanism known to the art can be used. After the neck extension 16 is broken off, the cap 22 is removed from the neck extension 16 and is threaded onto, or otherwise secured to, the neck 16 to close the container 10.

Referring to Figures 3 through 5, a particular embodiment is shown in which the neck extension 16 is formed to accommodate the insertion of a cylindrical plug 30. The neck extension 16 includes a medial lip 32 which can be circumferential and which is formed to engage a corresponding medial groove 34 circumferentially around the plug 30. The plug can include a top ledge 36 which matingly engages a shoulder 38 at the top end 20 of the neck extension so that when the plug 30 is inserted into the neck extension 16, it is retained by the shoulder 38 as well as by interaction of the intemal neck extension lip 32 with the extemal plug groove 34, and so that the top surface of the plug 36 is flush with the top end 20 of the neck extension 16. As shown in Figure 5, the plug 30 is closely fitted to the neck extension 16, i.e., its outer dimension is the same as the inner dimension of the neck extension 16. Also, as shown in Figure 5, the plug 30 is hollow, which accommodates some compression when the plug 30 is inserted into the neck extension 16 and pushed downwardly so that the lip 32 snaps into the groove 34. This constmction provides significant protection against tampering. In addition to the foregoing components, one can also heat seal the plug 30 to the neck extension by applying sealing heat to the seam where the plug ledge 36 meets the neck extension 16 adjacent the shoulder 38, as indicated at 40 in Figure 5.

The cap 22 is then threaded onto the outer thread of the formed surface of the neck extension 16 from the container 10. Once the neck extension 16 is broken off, the cap can be transferred to close the container neck. Since access to the contents of the container 10 is only possible by breaking off the neck extension, it would be readily apparent that tampering has occurred.

Referring now to Figures 6 through 8 another embodiment of the invention is shown, also including a neck extension 41 and a mating plug 42. Here, the plug 42 is formed with a lip 44, either at the bottom end thereof as shown, or, as indicated by shadow at 46, medially on the plug. In any event, as indicated in Figure 8, the plug 42 is hollow and contains a plurality of cut-out slots 48, in this case four circumferentially around the plug, to provide flexibility to the plug. The neck extension 41 is formed with an intemal groove 50 which engages the lip 44 or the plug 42. In this embodiment, the top surface 52 of the plug 42 is flush with the top end 54 of the neck extension 41. As in the previous embodiments, a cap 56 threadably engages the top end 54 of the neck extension and, after removing the neck extension, is transferred to the neck 56 to close the neck opening 58. As with the embodiments of Figures 3-5 one can heat seal the plug 42 to the neck extension 41 by application of heat at the seam 60 between the flush top surfaces of the neck extension 41 and plug 42. Altematively a plate can be applied over the plug 42 and heat sealed to the neck, or one can use adhesive that joins the components together.

Claims

1. A tamper-evident container, comprising: a container body; a neck on said container body defining an outlet opening therefor; a break off neck extension having an open bottom end connected to said neck adjacent said outlet opening and having a frangible region thereat; means for sealing the opposite end of said neck extension; and a cap carried by said neck extension and formed to close said outlet opening after break off of said neck extension.

2. The container of claim 1, including a plug closely fitted within said neck extension and means for retaining said plug in said neck extension.

3. The container of claim 2 in which said neck extension has an open top end, said plug having one end thereof adjacent the open end of said neck extension.

4. The container of claim 2 in which said retaining means comprises a heat seal between the top end of said neck extension and said plug.

5. The container of claim 2 in which said retaining means comprises a lip and a retaining groove therefor, one of said lip and retaining grooves being formed internally on said neck extension, the other being formed externally on said plug.

6. The container of claim 5 in which said lip is formed internally on said neck extension, said retaining groove being formed extemally on said plug.

7. The container of claim 5 in which said lip is formed extemally on said plug and said retaining groove is formed internally on said extension neck.

8. The container of claim 7 in which said lip is formed on said plug at a location distal from said one end thereof, said plug being hollow and split at said distal location to facilitate insertion into said neck extension.

9. The container of claim 6 including a ledge on the top end of said plug and a shoulder on the top end of said neck extension which matingly engages said ledge.

10. The container of claim 1 in which a region of said neck adjacent said outlet opening and a region of said neck extension adjacent the top end thereof are each formed with a threaded exterior surface, said cap being formed with a correspondingly threaded interior surface.

11. A tamper-evident container, comprising: a container body; a neck on said container body defining said outlet opemng therefor; a break off neck extension having an open top end and a bottom end, said neck extension being connected at its bottom end to said neck adjacent said outlet opening and having a frangible region thereat; a plug closely fitted within said neck extension so as to lie entirely within said neck extension; a lip and a retention groove therefor, one of said lip and retention groove being formed internally on said neck extension,the other formed extemally on said plug; a heat seal between the top end of said neck extension and said plug; and a cap carried by said neck extension and formed to close said outlet opening after break off of said neck extension.