Patent Description:
Maintaining the safety and efficacy of products is a major concern for both companies and consumers, especially in the pharmaceutical, healthcare, and wellness industries. Consumers' heath may be at risk if defective or contaminated products are used. Also, companies suffer huge losses of revenue and lose the trust of their consumers if inferior or harmful products are sold to consumers. Pharmaceutical and healthcare companies are actively working on their packaging to prevent tampering of the contents in order to protect the integrity of their products.

One common solution to these problems to is utilize tamper-proof packaging to ensure product safety. Thus, tamper-proof packaging has been an area of significant research over the past several decades. Several types of tamper-proof packaging solutions are available on the market; however, these solutions have often been deficient in enabling the consumer to differentiate between tampered and non-tampered products. Additionally, some tamper-proof packaging is not completely effective at preventing tampering from all sides of the container. Furthermore, in some tamper-proof containers, the inclusion of a tamper-proof mechanism interferes with the proper closure of the product dispensing orifice, thereby leading to leaking or contamination of the contents from the orifice during storage or transport.

<CIT> discloses a cap according to the preamble of claim <NUM>.

Due to the aforementioned issues, it is desirable to have an effective tamper evidence mechanism that also provides a visual confirmation to consumers that a tamper evidence mechanism was present even after it has been broken. It is also preferable that the tamper-proof container be easy to open and close and that the tamper evidence mechanism does not interfere with the operation of the cap.

According to the invention, a cap according to claim <NUM> is provided. Aspects of the present invention are also directed to a tamper-proof container according to claim <NUM>.

The present invention can further include a plug projecting from the inner surface of the lid, wherein the plug fits into the orifice to seal the orifice so as to provide moisture tight and resealable seal. Additionally, the plug can enter the orifice prior to the male component of the tamper evidence mechanism completing its engagement with the corresponding female component of the tamper evidence mechanism.

The invention is further directed to the neck of the cap including a sloped portion located at a front side of the cap and the lid including an extended part extending over the sloped portion, wherein the lid of the cap may be opened by pushing up from under the extended part. The sloped portion is made of a soft material and has an angel between about <NUM> degrees and about <NUM> degrees relative to a horizontal axis. The soft material of the sloped portion can be selected from a group comprising, silicon, LDPE, TPE, PE, rubber, or PET.

According to the invention two tamper evidence mechanisms are provided on opposite sides on the neck of the cap, with a male component of the tamper evidence mechanism which is provided on the rim of the lid and the female component of the tamper evidence mechanism which is provided on the neck of the cap; and a locking member which is provided on the female component and extends in a horizontal direction from one end of the female component to the other end of the female component. Further, in the present invention, the locking member is connected with one point of connection at one end of the female component and two points of connection at the other end of the female component.

The cap comprises an inner surface containing an orifice, a neck extending around the inner surface and having at least one tamper evidence mechanism, and a lid connected to the cap pivotally via a hinge and moveable between a closed position and an opened position, wherein the tamper evidence mechanism includes a male component, a female component and a locking member.

The invention further includes an extended part extending over the sloped portion, wherein the lid of the cap may be opened by pushing up from under the extended part, and wherein the sloped portion can be made made of a soft material and has an angle between about <NUM> degrees and about <NUM> degrees relative to a horizontal axis, wherein the soft material of the sloped portion can be selected from a group comprising, silicon, LDPE, TPE, PE, rubber, or PET.

Aspects of the present invention are directed to a novel tamper-proof container <NUM> including a container <NUM> to told contents, a cap <NUM>, and a tamper evidence mechanism <NUM>.

<FIG> are based upon engineering drawings used for the development and representation of a tamper-proof container <NUM> and represents the various embodiments of the present invention. Hence, the drawings are to scale and representative of the geometry of the tamper-proof container <NUM> comprising a container <NUM>, a cap <NUM>, and a tamper evidence mechanism <NUM> according to the present invention.

<FIG> illustrate an exemplary tamper-proof container <NUM> of the present invention in a closed position. <FIG> illustrates an exploded view of the tamper-proof container <NUM> in the closed position. The tamper-proof container <NUM> includes a container <NUM>, a cap <NUM>, and at least one tamper evidence mechanism <NUM>. The container <NUM> includes a bottom portion <NUM>, a side wall <NUM> and a top portion <NUM> defining an inner cavity of the container <NUM> wherein contents may be held. In an embodiment, the container <NUM> may be rigid and the side wall <NUM> may maintain its shape. In another embodiment, the container <NUM> may be flexible and the side wall <NUM> may be squeezed to move contents out of the container <NUM>. The top portion <NUM> of the container <NUM> includes an upright annular neck <NUM> which is hollow and serves as the sole opening for the passage of contents out of the container <NUM>. The cap <NUM> may be provided on the neck <NUM> of the container <NUM> so as to close the opening to the cavity. The diameter of the container <NUM> may be between about <NUM> and about <NUM>. In a preferred embodiment, the diameter of the container is about <NUM>. In another preferred embodiment, the diameter of the container is about <NUM>. The diameter of the cap <NUM> may be between about <NUM> and about <NUM>. In a preferred embodiment, the diameter of the cap is about <NUM>. In another preferred embodiment, the diameter of the cap is about <NUM>.

The present invention may be formed through the combination of the container <NUM> and cap <NUM> formed either integrally or non-integrally. If the cap <NUM> is integrally connected to the container <NUM>, the cap <NUM> and the container <NUM> may be formed of a blow-molded material or injection molded using methods known to one skilled in the art. If the cap <NUM> and container <NUM> are non-integrally connected, they may be connected, for example, by being screwed on to external or internal threads, friction fitted, snap fitted, or secured onto the container <NUM> in any other suitable manner known to one skilled in the art. In a preferred embodiment, the container <NUM> and cap <NUM> are connected by being snap fitted. In a preferred embodiment, the cap <NUM> is permanently fixed to the container <NUM> after or before the container is filled with contents, thereby rendering the container <NUM> and cap <NUM> into a connected system.

<FIG> illustrates a perspective view showing an exemplary tamper-proof container <NUM> in an opened position. The cap <NUM> may be molded as one piece and includes a substantially cylindrical neck <NUM>, an inner surface <NUM>, and a lid <NUM>. The lid <NUM> further includes, a bottom surface <NUM>, a side surface <NUM> and a plug <NUM> protruding from the bottom surface <NUM>. The neck <NUM> is provided around the inner surface and extends down from the inner surface <NUM> towards the container <NUM>. A back end of the lid <NUM> is connected to the neck <NUM> of the cap <NUM> via a hinge <NUM> and pivots about the hinge <NUM> to move the tamper-proof container <NUM> between the opened position and the closed position. In a preferred embodiment, the inner surface <NUM> is stationary and does not move during opening and closing of the tamper-proof container <NUM>. The lid <NUM> further includes an extended part <NUM> at a front end of the lid <NUM>. The extended part <NUM> may consist of a soft material and allows the user to easily and comfortably open and close the lid. In an embodiment, the material of the extended part may be silicon, LDPE, TPE, PE, rubber, PET, or any other suitable soft or rubberized material. In another embodiment, the material of the extended part may be polypropylene, high density polyethylene, low density polyethylene, polycarbonate, or polystyrene. In a preferred embodiment, the material of the extended part <NUM> is TPE.

The neck <NUM> includes a sloped portion <NUM> at a front end of the cap <NUM>. The sloped portion <NUM> slopes in an inward direction from the front of the cap <NUM> towards a back end of the cap <NUM>. The extended part <NUM> extends over the top of the sloped portion <NUM> to allow for a convenient and smooth single-handed opening and closing of the lid <NUM>. In an embodiment, the sloped portion <NUM> has an angle of between about <NUM> degrees and about <NUM> degrees relative to a horizontal axis. In a preferred embodiment, the sloped portion <NUM> has an angle of about <NUM> degrees relative to the horizontal axis. A user may place their thumb or other finger on the sloped portion <NUM> to push the extended part <NUM> in an upward direction from an underside of the extended part <NUM>. If a user is not able to use their hands or fingers to open the container, another object or an edge of a surface may be placed under the extended part <NUM> and used to push up on the extended part <NUM> to open the tamper-proof container <NUM>. In a preferred embodiment, the extended part <NUM> has a curved shape; however, the shape of the extended part <NUM> is not limited and can be any suitable shape. In an embodiment, the material of the sloped portion may be silicon, LDPE, TPE, PE, rubber, PET, or any other suitable soft or rubberized material. In another embodiment, the material of the sloped portion may be polypropylene, high density polyethylene, low density polyethylene, polycarbonate, or polystyrene. In a preferred embodiment, the material of the sloped portion is polypropylene.

The cap <NUM> further includes an orifice <NUM> provided on the inner surface <NUM> of the cap <NUM> by which contents can be dispensed from the tamper-proof container <NUM> when the tamper-proof container <NUM> is in the opened position. In a preferred embodiment, the orifice <NUM> is a circular shape, but it may be any suitable shape to dispense the contents held in the tamper-proof container <NUM>. The diameter of the orifice <NUM> may be between about <NUM> and about <NUM>. In a preferred embodiment, the diameter of the orifice <NUM> is about <NUM>. A user may squeeze the side wall <NUM> of the container to push the containers out of the orifice <NUM>. When contents is dispensed from the orifice <NUM>, a user can flip the tamper-proof container <NUM> upside down and apply the contents directly to the desired area without having to take the contents on their finger first. There is a smooth transition from the sloped portion <NUM> to the inner surface <NUM> of the cap <NUM> to facilitate the application of the contents directly to the desired area. Thus, the sloped portion <NUM> can serve as an applicator and provides a smooth surface for direct application of the contents to an area. Further, the slope of the sloped portion <NUM> allows for easy direct application of the contents to difficult to reach areas with minimal manipulation of the tamper-proof container <NUM> by the user. This direct application of the contents to the desired area prevents contamination of the contents by avoiding contact with a user's fingers prior to application and prevents waste of the contents.

In a closed position, the plug <NUM> extends in a downwards direction from the bottom surface <NUM> of the lid <NUM> towards the container <NUM> and fits into the orifice <NUM> to create a secure air tight seal to prevent contamination and leaking of the contents. In an embodiment, the tamper-proof container <NUM> is moisture-tight and is resealable to maintain the moisture tight properties. As used herein, the term "resealable" means that the tamper-proof container <NUM> can be opened or reopened and closed or reclosed a numerous amount of times (e.g. more than <NUM> times) and still retain its moisture-tight properties. As used herein, the term "moisture-tight" means the moisture ingress of the container is less than about <NUM> micrograms of water/day, determined by the following test method: (a) place approximately one gram of molecular sieve in the container and record the weight; (b) close the resealable mechanism; (c) place the sealed container in an environment chamber at conditions of <NUM>% relative humidity and <NUM>°F (<NUM>); (d) after one day, weigh the container containing the molecular sieve; (e) after approximately two weeks, weigh the container; and (f) subtract the first day sample from the value obtained and divide by the number of days to calculate the moisture ingress of the container in units of micrograms of water/day.

The cap <NUM> further comprises at least one tamper evidence mechanism <NUM> provided on the cap <NUM> to prevent tampering with the contents prior to a user opening the tamper-proof container <NUM> for the first time. There can be any suitable number of tamper evidence mechanisms <NUM> provided on the cap <NUM>. In an embodiment, there is one tamper evidence mechanism <NUM>. In a preferred embodiment, there are two tamper evidence mechanisms <NUM> located on either side of the hinge <NUM> so as to be on opposite sides around the cap <NUM>. Two tamper evidence mechanisms <NUM> provide the benefit of additional protection by preventing the lid <NUM> from being lifted or opened from either side of the hinge <NUM> or the extended part <NUM> without breaking at least one of the two tamper evidence mechanisms <NUM> to indicate signs of tampering. In a preferred embodiment, each of the tamper evidence mechanisms <NUM> have the same structure and function.

Each tamper evidence mechanism <NUM> includes a male component 304A, a corresponding female component 304B, and a locking member 304C. The male component 304A is provided on a rim <NUM> of the side surface <NUM> of the lid <NUM>. The male component 24A protrudes from the rim <NUM> of the side surface <NUM> of the lid <NUM> in an upwards direction when the tamper-proof container <NUM> is in the opened position. The shape of the male component 304A can be any suitable shape. In a preferred embodiment, the male component 304A has a substantially rectangular shape. The male component 304A further includes a lip <NUM> at a top portion of the male component 204A that extends in a substantially perpendicular direction from the remainder of the male component 304A.

The female component 204B includes a recess provided on a rim <NUM> of the neck <NUM> of the cap <NUM> and extends down onto the neck <NUM> of the cap <NUM>. In a preferred embodiment, the female component 304B is a substantially rectangular shape, but the present invention is not limited to this shape and the female component can be any suitable shape. The tamper evidence mechanism <NUM> further includes a locking member 304C. The locking member 304C can be any suitable shape and size. In a preferred embodiment, the locking member 304C is in the form of a band and extends from one end of the female component 304B to the other end in a horizontal direction, thereby connecting the two ends of the female component of the tamper mechanism <NUM>. In an embodiment, the length of the locking member may be between about <NUM> and about <NUM>. In a preferred embodiment, the length of the locking member is about <NUM>. A gap exists between the locking member 304C and the neck <NUM> of the cap <NUM>.

<FIG> depicts an exemplary female component of the tamper evidence mechanism of the present invention. Each end of the locking member 304C is connected to an end of the female component 304B in the horizontal direction. The locking member 304C is connected so as to have a stronger connection at one end as compared to the other end. In a preferred embodiment, the locking member 304C is connected by a single point of connection <NUM> at one end of a female component 304B, and by two points of connection <NUM> & <NUM> at the other end of the female component 304B. The locking member 304C has a stronger connection at the end with two points of connection as compared to the end with the single point of connection. Therefore, when the lid <NUM> is opened for the first time, the locking member 304C will detach from the female component 304B predictably and consistently at the end with the single point of connection only and remain attached at the opposite end having two points of connection. This provides clear indication of prior opening to the user since the severed locking member 304C is still attached at one end once the lid <NUM> has been opened for the first time providing visual confirmation that a tamper mechanism was present and has been broken. Additionally, since the locking member 304C remains attached at one end, there is no need to discard the locking member 304C once the tamper-proof container <NUM> has been opened. In an embodiment, the locking member 304C may be connected with three points of connection at one end and a single point of connection at the other end. In another embodiment, the locking member may be connected with two points of connection at one end and three points of connection at the other end. The present invention may have any combination of connections so long as the connection at one end is stronger than the connection at the opposite end.

<FIG> is a view of an exemplary tamper evidence mechanism <NUM> secured on the tamper-proof container <NUM> of the present invention. When the tamper-proof container <NUM> is closed for the first time after being filled with the contents, the tamper evidence mechanism <NUM> is secured onto the tamper-proof container <NUM>. When the tamper evidence mechanism <NUM> is attached, the lid <NUM> is secured in the closed position over the inner surface <NUM> of the cap <NUM>, thereby preventing access to the contents held in the container <NUM>. In order to secure the tamper proof mechanism <NUM>, the male component 304A engages with the female component 304B and sits in the recess of the female component 304B with the locking member 304C provided on top of the male component 304A. The bottom of the locking member 304C resists the movement of the lip <NUM> of the male 304A so as to lock and hold the male component 304A in place. In this configuration, the male component 304A cannot be removed from the female component 304B without detaching the locking member 304C from at least one end indicating tampering. The tamper evidence mechanism <NUM> remains intact until the lid <NUM> is opened for the first time. When the user moves the lid <NUM> in an upward direction to open the tamper-proof container <NUM> for the first time, the lip <NUM> of the male component 304B pushes against the locking member 304C causing the locking member <NUM>04C to disengage at one end to allow the lid <NUM> to be lifted and the tamper-proof container <NUM> to be opened.

<FIG> illustrate a process of securing the tamper evidence mechanism <NUM> on the present invention. After contents is filled in the container, the lid <NUM> is closed for the first time, and the tamper evidence mechanism is enabled. The lid <NUM> is moved in a downward direction to cover the orifice <NUM> on the inner surface <NUM> of the cap <NUM>. As can be seen in <FIG>, as the lid <NUM> pivots about the hinge <NUM> in the downwards direction, the plug <NUM> substantially enters the orifice <NUM> to seal the orifice <NUM> before the male component 304A of the tamper evidence mechanism <NUM> completes its engagement with the corresponding female component 304B. As can be seen in <FIG>, while the plug <NUM> enters the orifice <NUM>, the male component 304A continues to enter the gap in the corresponding female components 304B until the tamper evidence mechanism <NUM> is secured in place. Only after the plug <NUM> has entered the orifice <NUM> completely to seal the orifice <NUM>, does the male component 304A complete its engagement with the corresponding female component 304B.

<FIG> illustrate a cross-sectional view of the process of closing the lid <NUM> of the cap <NUM> for the first time according to the present invention. <FIG> further indicate the process in which the plug <NUM> enters the orifice <NUM>. Additionally, as the lid <NUM> is moved down into the closed position, the male component 304A of the tamper evidence mechanism <NUM> provided on the lid <NUM> engages with the female component 304B. As can be seen in <FIG>, the plug <NUM> substantially enters the orifice <NUM> before the engagement of the tamper evidence mechanism <NUM> is complete.

<FIG> illustrates a top view of the cap of the present invention in an opened position. Line <NUM> indicates that the center point of the tamper evidence mechanism <NUM> is closer to the hinge <NUM> as compared to the center point of the orifice <NUM>. Accordingly, in a typical container with this arrangement, the tamper evidence mechanism <NUM> would engage and lock before the plug <NUM> completely enters the orifice <NUM>. However, if the tamper evidence mechanism <NUM> engages and locks in place prior to the plug <NUM> entering the orifice <NUM>, the lid <NUM> will not be closed properly and will not be flat against the inner surface <NUM> of the cap <NUM> as desired. Instead, a gap may exist between the lid <NUM> and the inner surface <NUM> of the cap <NUM> causing the contents to spill out, be contaminated, or exposed to harmful environmental factors. In order to address this problem, in the present invention, the length of the male component 304A projecting from the rim <NUM> of the lid <NUM> is less than the length of the plug <NUM> projecting from the inner surface <NUM> of the cap <NUM> so as to facilitate entry of the plug <NUM> into the orifice <NUM> before the male component 304A of the tamper evidence mechanism <NUM> is fully locked into the corresponding female component 304B. In an embodiment, the projection length of the plug <NUM> from an inner surface <NUM> of the lid <NUM> to the end of the plug <NUM> may be between about <NUM> and about <NUM>. In a preferred embodiment, the projection length of the plug is about <NUM>. In an embodiment, the length of the male component 304A from the rim <NUM> of the side surface <NUM> of the lid <NUM> to the end of the male component 304A may be between about <NUM> and about <NUM>. In a preferred embodiment, the length of the male component 204A is about <NUM>. In a preferred embodiment, the ratio of the projection length of the male component 204A to the projection length of the plug is <NUM>:<NUM>. The distance between the hinge <NUM> and the center of the orifice <NUM> is between about <NUM> and about <NUM>. In a preferred embodiment, the distance between the hinge <NUM> and the center of the orifice <NUM> is about <NUM>. The distance between the hinge <NUM> and the center of the female component 304B is between about <NUM> and about <NUM>. In a preferred embodiment, the distance between the hinge <NUM> and the center of the female component 304B is about <NUM>.

<FIG> depict the process of opening the tamper-proof container <NUM> for the first time. As can be seen in <FIG>, when the user first encounters the tamper-proof container <NUM>, the tamper evidence mechanism <NUM> is clearly intact on either side of the cap <NUM> to indicate to the user that there has been no tampering with the contents held in the container <NUM>. As the user beings to lift up the lid <NUM> by pushing the extended part <NUM> up from an underside of the extended part <NUM>, the tamper evidence mechanism <NUM> begins to disengage. A user may open the tamper-proof container <NUM> in a flip motion with a single hand. The force applied by the user to the lid <NUM> causes the male component 304A to press against the locking member 304C and put pressure on the locking member 304C until the locking member 304C breaks at one end. In a preferred embodiment, the locking band 304C breaks at the end with the single point of connection and remains connected to the female component 304B at the other end with the two points point of connection. As can be seen in <FIG>, once the lid <NUM> is opened, and the tamper evidence mechanism <NUM> is broken, the locking member 304C remains attached to the female component 304B at one end so as to provide visual confirmation of the tamper evidence mechanism <NUM> being broken. Thus, if the contents have been previously accessed, the subsequent user will have clear visual indication via the broken and attached locking member 304C. In a preferred embodiment, two tamper evidence mechanisms <NUM> are provided on either side of the orifice <NUM> so as to prevent opening the lid <NUM> from any point around the lid <NUM> without breaking one or both tamper evidence mechanisms <NUM>.

<FIG> depicts the cap <NUM> of the present invention in the opened position removed from the container <NUM>. Once the lid <NUM> has been opened for the first time, the locking member 304C of the tamper evidence mechanism <NUM> remains attached to the female component 304B. The locking member 304C will remain attached to the female component 304B at the end with the stronger connection, i.e. two points of connection <NUM> and <NUM>, instead of the end with the weaker connection, i.e. the single point of connection <NUM>. In a preferred embodiment, the end with the stronger connection may be the end of the female component 304B closest to the hinge <NUM>.

In an embodiment, the material of the tamper evidence mechanism <NUM>, the container <NUM>, the lid <NUM> and the neck <NUM> of the cap <NUM> may be polypropylene, high density polyethylene, low density polyethylene, polycarbonate, or polystyrene. In a preferred embodiment, the material of the tamper evidence mechanism <NUM>, the container <NUM>, the lid <NUM>, and the neck <NUM> of the cap <NUM> is polypropylene.

The contents held in the container tube may be any compound or composition that can be used to cleanse the skin, provide pain relief, or provide overall health and wellness benefits to the user. Non-limiting examples of the contents may include pharmaceutical active ingredients including over the counter actives, behind the counter actives, prescription actives, or any combination thereof.

In an embodiment of the present invention, the contents may be available in various forms and selected from group comprising gel, lotion, cream, oil, emulsion, ointment and powder. In an embodiment, the contents held in the container is a cream or gel containing diclofenac sodium. In a preferred embodiment, the contents held in the container is a combination of diclofenac sodium, ammonia, carbomer homopolymer type c, coco-caprylate/caprate, isopropyl alcohol, mineral oil, polyoxyl <NUM> cetostearyl ether, propylene glycol, and water.

The tamper-proof container <NUM> of the present invention may be compatible with any pump or spray device, including, but not limited to airless pumps.

Claim 1:
A cap (<NUM>) comprising:
an inner surface (<NUM>) containing an orifice (<NUM>);
a neck (<NUM>) extending around the inner surface and having at least one tamper evidence mechanism (<NUM>); and
a lid (<NUM>) connected to the cap pivotally via a hinge (<NUM>) and moveable between a closed position and an opened position,
wherein the tamper evidence mechanism includes a male component (304A), a female component (304B) and a locking member (304C),
wherein the male component (304A) of the tamper evidence mechanism is provided on a rim (<NUM>) of the lid,
wherein the female component (304B) of the tamper evidence mechanism is provided on the neck (<NUM>) of the cap, and
wherein the locking member (304C) is provided on the female component (304B) and extends in a horizontal direction from one end of the female component to the other end of the female component,
characterized in that the neck (<NUM>) of the cap includes a sloped portion (<NUM>) located at a front side of the cap and the lid (<NUM>) includes an extended part (<NUM>) extending over the sloped portion, and wherein the lid of the cap may be opened by pushing up from under the extended part (<NUM>).