Patent Grant
11939121
The present disclosure relates to cartons designed for housing and transporting drug products and for use in housing and transporting trial products used in blinded clinical trials. The present disclosure also relates to reseal panels that can be used with such cartons and to related methods of assembly and use.
Clinical trials for many pharmaceutical drugs require that a drug and a placebo be delivered and administered in a blinded study. As part of the blinded clinical trial protocols, the drug and placebo are placed in separate unmarked containers. Accordingly, the administering technician and recipient are blind as to the identity of the product, the concentration thereof, or other characteristics being studied that may otherwise be reported on the retail label of the drug container.
To facilitate transport and delivery of the drug/placebo, the unmarked containers can be sealed in a box. For instance, an unmarked dosage vial or tube can be placed in a box having a lid that can be folded over to close the box. Once the lid is closed, a sealing sticker, often referred to as a tamper seal, is manually placed on the outside of the box so as to extend between the lid and the body of the box, thereby fixing the lid closed and sealing the contents therein. The unbroken sealing sticker indicates that the box has not been opened following sealing of the product therein, thereby ensuring that there has been no tampering with the product. The box can also be marked with a label that includes an identification number or other information associated with the included product. However, this identifying information is keyed to a reference list and is only useful in identifying the product in combination with that list. Accordingly, the box may also lack any direct, product-identifying marks or labels to ensure fidelity of the blinded study.
One of the difficulties in conducting blinded trials is ensuring that there is no indirect identifying and/or associating information that can inadvertently convey to the participants information about the drug/placebo they are taking. For instance, variation between the placement (e.g., location, orientation, etc.) of the sealing stickers on the boxes can provide an indication of product identity. Specifically, differences in the placement of sealing stickers between adjacent boxes or between current and former boxes may cause a participant to infer that the products between the two boxes are different or that one box is more likely to have an active drug as opposed to a placebo. Such perceived differences can defeat the objective of the blinded trials. Because even slight differences between the human-applied sealing stickers on two separate boxes can lead the technician or recipient to believe that the containers disposed therein contain different products, controlling such perceived differences can be vital to the efficacy and fidelity of the clinical trial.
Another problem associated with the above packaging of trial products is that it is frequently necessary to house and/or transport the drugs at freezing temperatures. Such freezing temperatures can occasionally result in failure of the adhesive on the sealing sticker which, in turn, can result in automatic opening of boxes or at least enable to boxes to be freely opened. Failure of the sealing sticker thus defeats the integrity of the blinded study because there is no longer any assurance that the corresponding boxes have not been opened to discern the contents therein.
In addition, boxes that are intentionally opened during a blinded study may need to be sealed or resealed for a variety of purposes without perceived differences between sealed or resealed boxes. Where a sealing sticker has been previously placed on the outside of a box, this can be difficult if not impossible to do.
Boxes using the above discussed sealing stickers are also frequently used for storing and transporting drug products, e.g., active, therapeutic drugs that have previously received clearance from the Food and Drug Administration (FDA) or other equivalent regulatory body, that are being sold in commerce. In those cases, the sealing stickers primary ensure that there has been no tampering with the drug product once the drug product has been placed within the box. In this context, many of the concerns associated with using sealing stickers in blinded clinical trials are also applicable for selling drug products. For example, some drug products also need to be shipped or stored at freezing temperatures that can result in failure of the sealing stickers. Where the sealing sticker has failed and the box can be freely opened, the integrity of the drug product can no longer be verified. Furthermore, it can occasionally be necessary to open a box containing a drug product, prior to sale, such as to exchange or update a drug product, product label, or product supplement. In that case, it can be desirable to reseal the box with minimal evidence of tampering.
In each of the above situations, it would also be desirable to have boxes that prevent sealed boxes from being improperly opened and resealed and/or that produce an indication of when a sealed box has been improperly opened or attempts have been made to improperly open.
Accordingly, what is needed in the art are boxes and assemblies that overcome all or some of the above shortcomings, including products and methods for sealing, opening, and/or resealing boxes in a manner that overcomes all or some of the above shortcomings.
Various independent aspects and examples consistent with the present teaching are set out in the following numbered clauses:
Clause 1: A zipper carton comprising:
Clause 2: The zipper carton as recited in clause 1, wherein a crease is formed at an intersection between the base and the first retention flap.
Clause 3: The zipper carton as recited in clause 1, wherein the locking tab further comprises a second retention flap projecting from the base and being foldable relative to the base.
Clause 4: The zipper carton as recited in clause 3, wherein the locking tab is configured so that when the first and second retention flaps are each folded from a relaxed position to a folded position, at least a portion of the locking tab including the first and second retention flaps can be slid through the slot and after the first and second retention flaps pass through the slot, the first and second retention flaps automatically resiliently rebound at least partially toward the relaxed positions so as to block retraction of the locking tab from the slot.
Clause 5: The zipper carton as recited in clause 3, wherein the base of the locking tab has a front face and an opposing back face that the longitudinally extend between a first side edge and an opposing second side edge, the first retention flap projecting from the first side edge of the base and the second retention flap projecting from the second side edge of the base.
Clause 6: The zipper carton as recited in clause 5, wherein when the first retention flap and the second retention flap are in the relaxed position, the first retention flap, the second retention flap and the base are disposed in a common plane.
Clause 7: The zipper carton as recited in clause 3, wherein the first retention flap and the second retention flap are each folded over an angle of at least 150° when they are folded from the relaxed position to the folded position.
Clause 8: The zipper carton as recited in clause 5, wherein the base has a linear length extending between the opposing first and second side edges, the linear length of the base being equal to or smaller than the length of the slot.
Clause 9: The zipper carton as recited in clause 3, wherein the locking tab further comprises a third retention flap projecting from the base and being foldable relative to the base.
Clause 10: The zipper carton as recited in clause 9, wherein the locking tab is configured so that when the first, second, and third retention flaps are each folded from a relaxed position to a folded position, at least a portion of the locking tab including the first, second, and third retention flaps can be slid through the slot and after the first, second, and third retention flaps pass through the slot, the first, second, and third retention flaps automatically resiliently rebound at least partially toward the relaxed positions so as to block retraction of the locking tab from the slot.
Clause 11: The zipper carton as recited in clause 9, wherein the base of the locking tab has a front face, an opposing back face, and a top edge that longitudinally extends between a first side edge and an opposing second side edge, the first retention flap projecting from the first side edge of the base, the second retention flap projecting from the second side edge of the base, and the third retention flap projecting from the top edge of the base.
Clause 12: The zipper carton as recited in clause 1, wherein the slot has a maximum width that is less than 3 mm.
Clause 13: The zipper carton as recited in clause 1, wherein the slot has a width that varies along the length of the slot.
Clause 14: The zipper carton as recited in clause 1, wherein the first panel and the locking panel assembly are each comprised of a flexible sheet of paper.
Clause 15: The zipper carton as recited in clause 1, wherein the first panel and the locking panel assembly are each free of any adhesive applied thereto.
Clause 16: The zipper carton as recited in clause 1, wherein the locking panel assembly further comprises an extension panel, the removable zipper tear strip being disposed between the extension panel and the locking tab.
Clause 17: The zipper carton as recited in clause 16, further comprising:
Clause 18: The zipper carton as recited in clause 1, further comprising:
Clause 19: The zipper carton as recited in clause 18, further comprising a drug product or trial product disposed within the compartment.
Clause 20: The zipper carton as recited in clause 19, wherein the trial product comprises an active drug, a comparator drug, or a placebo.
Clause 21: The zipper carton as recited in clause 18, further comprising:
Clause 22: The zipper carton as recited in clause 21, wherein the cover panel assembly projects from an upper end of a back panel of the encircling sidewall that is opposite the front panel.
Clause 23: The zipper carton as recited in clause 21, wherein a secondary slot is formed at or adjacent to an intersection between the cover panel assembly and the locking panel assembly.
Clause 24: The zipper carton as recited in clause 18, further comprising:
Clause 25: A zipper carton in a closed and locked position, comprising:
Clause 26: The zipper carton in a closed and locked position as recited in clause 25, further comprising a second retention flap projecting from the base and being passed through the slot, the second retention flap being angled relative to the base so as to block retraction of the locking tab out of the slot.
Clause 27: The zipper carton in a closed and locked position as recited in clause 26, further comprising a third retention flap projecting from the base and being passed through the slot, the third retention flap being disposed between the first retention flap and the second retention flap so as to block folding of the first retention flap and the second retention flap toward the base.
Clause 28: The zipper carton in a closed and locked position as recited in clause 26, wherein the first retention flap and the second retention flap are inwardly folded toward the removable zipper tear strip.
Clause 29: The zipper carton in a closed and locked position as recited in clause 27, wherein the third retention flap is biased against a product retainer.
Clause 30: A method for closing a zipper carton, the method comprising:
Clause 31: A method for closing a zipper carton, the method comprising:
Clause 32: A method for closing a zipper carton, the method comprising:
Clause 33: The method as recited in clause 32, wherein the third retention flap is disposed between the first retention flap and the second retention flap so as to block folding of the first retention flap and the second retention flap back to the folded position when the first retention flap, the second retention flap and the third retention flap are resiliently rebounded at least partially toward the relaxed position.
Clause 34: The method as recited in clause 32, wherein the third retention flap is blocked by a product retainer as it resiliently rebounds at least partially toward the relaxed position.
Clause 35: A zipper carton comprising:
Clause 36: The zipper carton as recited in clause 35, wherein the cover panel assembly and the locking panel assembly are held in the closed and locked position without the use of an adhesive.
Clause 37: The zipper carton as recited in clause 35, wherein the encircling sidewall is self-supporting without the use of an adhesive.
Clause 38: The zipper carton as recited in clause 35, wherein no adhesive is applied to the locking panel assembly or the front panel.
Clause 39: The zipper carton as recited in clause 35, wherein the cover panel assembly, the locking panel assembly and the encircling sidewall are each comprised of a flexible sheet of paper.
Clause 40: The zipper carton as recited in clause 35, wherein the locking tab comprises:
Clause 41: The zipper carton as recited in clause 40, further comprising:
Clause 42: The zipper carton as recited in clause 40, wherein the locking tab further comprises a second retention flap projecting from the base and being foldable relative to the base.
Clause 43: The zipper carton as recited in clause 42, wherein the locking tab further comprises a third retention flap projecting from the base and being foldable relative to the base.
Clause 44: The zipper carton as recited in clause 35, wherein the slot has an elongated length extending between opposing ends and the locking tab has a linear length extending between opposing terminal side edges, the liner length of the locking tab being greater than the length of the slot.
Clause 45: The zipper carton as recited in clause 35, wherein the locking panel assembly further comprises an extension panel extending between the cover panel assembly and the removable zipper tear strip.
Clause 46: A reseal panel comprising:
Clause 47: The reseal panel as recited in clause 46, wherein the primary locking tab, the secondary locking tab and the zipper tear strip are each comprised of a flexible sheet of paper.
Clause 48: The reseal panel as recited in clause 46, wherein the primary locking tab, the secondary locking tab and the zipper tear strip are each free of any adhesive applied thereto.
Clause 49: The reseal panel as recited in clause 46, wherein the primary locking tab further comprises a second retention flap projecting from the base.
Clause 50: The reseal panel as recited in clause 49, wherein the primary locking tab further comprises a third retention flap projecting from the base.
Clause 51: The reseal panel as recited in clause 46, further comprising an extension panel extending between the zipper tear strip and the secondary locking tab.
Clause 52: A zipper carton comprising:
Clause 53: A method for packaging a drug product or trial product, the method comprising:
Clause 54: The method as recited in clause 53, further comprising removing the zipper tear strip so as to separate the locking tab from a remainder of the locking panel assembly.
Clause 55: The method as recited in clause 54, further comprising:
Clause 56: The method as recited in clause 55, further comprising:
Each of the above independent aspects of the disclosure may include any of the features, options and possibilities set out in this document, including those under the other independent aspects, and may also include any combination of any of the features, options and possibilities set out in this document.
Various embodiments of the present invention will now be discussed with reference to the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope.
Before describing the present disclosure in detail, it is to be understood that this disclosure is not limited to parameters of the particularly exemplified systems, methods, apparatus, products, processes, compositions, and/or kits, which may, of course, vary. It is also to be understood that the terminology used herein is only for the purpose of describing particular embodiments of the present disclosure, and is not necessarily intended to limit the scope of the disclosure in any particular manner. Thus, while the present disclosure will be described in detail with reference to specific embodiments, features, aspects, configurations, etc., the descriptions are illustrative and are not to be construed as limiting the scope of the claimed invention. Various modifications can be made to the illustrated embodiments, features, aspects, configurations, etc. without departing from the spirit and scope of the invention as defined by the claims. Thus, while various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present disclosure pertains. While a number of methods and materials similar or equivalent to those described herein can be used in the practice of the present disclosure, only certain exemplary materials and methods are described herein.
Various aspects of the present disclosure, including devices, systems, methods, etc., may be illustrated with reference to one or more exemplary embodiments or implementations. As used herein, the terms “alternative embodiment” and/or “exemplary implementation” means “serving as an example, instance, or illustration,” and should not necessarily be construed as preferred or advantageous over other embodiments or implementations disclosed herein. In addition, reference to an “implementation” of the present disclosure or invention includes a specific reference to one or more embodiments thereof, and vice versa, and is intended to provide illustrative examples without limiting the scope of the invention, which is indicated by the appended claims rather than by the following description.
It will be noted that, as used in this specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the content clearly dictates otherwise. Thus, for example, reference to a “panel” includes one, two, or more panels. As used throughout this application the words “can” and “may” are used in a permissive sense (i.e., meaning having the potential to), rather than the mandatory sense (i.e., meaning must). Additionally, the terms “including,” “having,” “involving,” “containing,” “characterized by,” variants thereof (e.g., “includes,” “has,” and “involves,” “contains,” etc.), and similar terms as used herein, including the claims, shall be inclusive and/or open-ended, shall have the same meaning as the word “comprising” and variants thereof (e.g., “comprise” and “comprises”), and do not exclude additional, un-recited elements or method steps, illustratively.
Various aspects of the present disclosure can be illustrated by describing components that are coupled, attached, connected, and/or joined together. As used herein, the terms “coupled”, “attached”, “connected,” and/or “joined” are used to indicate either a direct connection between two components or, where appropriate, an indirect connection to one another through intervening or intermediate components. In contrast, when a component is referred to as being “directly coupled”, “directly attached”, “directly connected,” and/or “directly joined” to another component, no intervening elements are present or contemplated. Thus, as used herein, the terms “connection,” “connected,” and the like do not necessarily imply direct contact between the two or more elements. In addition, components that are coupled, attached, connected, and/or joined together are not necessarily (reversibly or permanently) secured to one another. For instance, coupling, attaching, connecting, and/or joining can comprise placing, positioning, and/or disposing the components together or otherwise adjacent in some implementations.
As used herein, directional and/or arbitrary terms, such as “top,” “bottom,” “front,” “back,” “left,” “right,” “up,” “down,” “upper,” “lower,” “inner,” “outer,” “internal,” “external,” “interior,” “exterior,” “proximal,” “distal” and the like can be used solely to indicate relative directions and/or orientations and may not otherwise be intended to limit the scope of the disclosure, including the specification, invention, and/or claims.
Where possible, like numbering of elements have been used in various figures. In addition, similar elements and/or elements having similar functions may be designated by similar numbering (e.g., element “10” and element “210.”) Furthermore, alternative configurations of a particular element may each include separate letters appended to the element number. Accordingly, an appended letter can be used to designate an alternative design, structure, function, implementation, and/or embodiment of an element or feature without an appended letter. Similarly, multiple instances of an element and or sub-elements of a parent element may each include separate letters appended to the element number. In each case, the element label may be used without an appended letter to generally refer to instances of the element or any one of the alternative elements. Element labels including an appended letter can be used to refer to a specific instance of the element or to distinguish or draw attention to multiple uses of the element. In contrast to using a letter, one or more prime symbols “′” can be appended to an element number and used in the same way as a letter. However, element labels including an appended letter or prime symbol are not meant to be limited to the specific and/or particular embodiment(s) in which they are illustrated. In other words, reference to a specific feature in relation to one embodiment should not be construed as being limited to applications only within said embodiment.
It will also be appreciated that where a range of values (e.g., less than, greater than, at least, and/or up to a certain value, and/or between two recited values) is disclosed or recited, any specific value or range of values falling within the disclosed range of values is likewise disclosed and contemplated herein. Thus, disclosure of an illustrative measurement or distance less than or equal to about 10 units or between 0 and 10 units includes, illustratively, a specific disclosure of: (i) a measurement of 9 units, 5 units, 1 units, or any other value between 0 and 10 units, including 0 units and/or 10 units; and/or (ii) a measurement between 9 units and 1 units, between 8 units and 2 units, between 6 units and 4 units, and/or any other range of values between 0 and 10 units.
It is also noted that systems, methods, apparatus, devices, products, processes, compositions, and/or kits, etc., according to certain embodiments of the present invention may include, incorporate, or otherwise comprise properties, features, aspects, steps, components, members, and/or elements described in other embodiments disclosed and/or described herein. Thus, reference to a specific feature, aspect, steps, component, member, element, etc. in relation to one embodiment should not be construed as being limited to applications only within said embodiment. In addition, reference to a specific benefit, advantage, problem, solution, method of use, etc. in relation to one embodiment should not be construed as being limited to applications only within said embodiment.
The headings used herein are for organizational purposes only and are not meant to be used to limit the scope of the description or the claims. To facilitate understanding, like reference numerals have been used, where possible, to designate like elements common to the figures.
In general, the present disclosure is directed to zipper cartons that are designed to receive a drug product and/or a trial product, and to related methods of assembly and use. The term “drug product(s),” as used herein, refers to an active, therapeutic drug, such as one that has previously received clearance from the Food and Drug Administration (FDA) or other equivalent regulatory body so that it can be sold in commerce. In contrast, as discussed below in greater detail, the term “trial product(s),” as used herein, refers to a product being used in a blinded clinical trial and can include an active drug product that is under investigation, a related placebo product, a control product and/or a comparator product. In general, the zipper carton includes a carton body having a cover panel assembly extending therefrom that can used to cover and lock closed an access opening of the carton body. The carton can be configured with a removable zipper tear strip to enable opening the carton body to access a drug product or to access a trial product housed therein as part of a blinded trial. The present disclosure is also directed to reseal panels that can be used with the zipper cartons and methods of use. The reseal panels can attached to zipper cartons that have been opened by removal of the zipper strip to enable reclosing and relocking zipper cartons.
Accordingly, some embodiments of the zipper carton described herein can comprise a pre-assembled and/or erectable, disposable, sealable, single use box adapted for housing a drug product or assembling a blinded clinical trial kit. The zipper carton can be configured to receive one or more drug products/blinded trial products therein and can be erectable and sealable without the application of any adhesive or sealing agent. For instance, the zipper carton can be sealed in a secure manner without the use of adhesive on the zipper carton or by applying an external sealing tape or sealing sticker. More specifically, various embodiments of the zipper carton assembly described herein can be assembled, erected, formed, manipulated, closed and locked without the use of any adhesive material. For instance, some embodiments can include a flat zipper carton template that can be assembled, erected into a self-supporting zipper carton and then closed and locked after receiving a drug product/trial product without using a glue, sticker, tape or other form of adhesive to connect two portions of the template together.
Using an adhesive to assemble, erect, close or lock a zipper carton can be undesirable in the context where the drug product/trial product needs to be held at low or freezing temperatures, such as during transport or storage, since such temperatures can cause failure of the adhesive. In turn, failure of the adhesive can enable access to the drug product/trial product therein and thereby jeopardize the integrity of a blinded trial and/or bring into question the integrity of the product. Furthermore, the application of external sealing tape or stickers is typically undesirable because they can distinguish zipper cartons that includes an active trial product from a zipper carton that includes a placebo trial product and thus influence a blinded trial.
Thus, embodiments of the present disclosure provide a variety of advantages above and/or over know containers and/or provide unique solutions to problems in the art not otherwise addressed by existing containers. It is noted, however, that the present disclosure does not preclude the use of an adhesive, either independently or in the form of a sticker, tape, or the like, on or within the zipper cartons disclosed herein. Rather, the zipper cartons are configured so that if desired the use of adhesive can be eliminated or at least decreased. Various embodiments will now be discussed in further detail with reference being made to the Figures of the present disclosure.
Depicted in
An elongated slot 41 extends through front panel 34 and communicates with compartment 24. As discussed below in greater detail, slot 41 is used to lock zipper carton 10a in a closed position. Slot 41 has a length L1 that extends between a first end 42 and an opposing second end 44. Slot 41 also has a width extending along the length L1. The width typically has a maximum or average dimension that is less than 4 mm and more commonly less than 3.5 mm or 3 mm. Other dimensions can also be used. In the depicted embodiment, a tab 46 centrally projects into slot 41 so that slot 41 is wider at opposing ends 42 and 44 and narrower in the middle. The function of tab 46 will be discussed below in greater detail. In alternative embodiments, tab 46 can be eliminated and the width of slot 41 can be constant. Slot 41 is typically oriented so as to be disposed parallel to top edge 34a and/or bottom edge 34b.
In the embodiment depicted, first side panel 38 is comprised of an exterior side panel 50a and an opposing interior side panel 52a. Panels 50a and 52a extend between upper edge 38a and lower edge 38b and also between a front edge 38c and an opposing back edge 38d. Panels 50a and 52a are connected together at upper edge 38a and bound a pocket 54a therebetween. A front opening 56a to pocket 54a is formed along front edge 38c while a back opening 58a to pocket 54a is formed along back edge 38d. As will be discussed below in more detail, a notch 59 is recessed into front edge 38c of exterior side panel 50a and extends back toward back edge 38d. Notch 59 also laterally passes through exterior side panel 50a.
Similarly, second side panel 40 is comprised of an exterior side panel 50b and an opposing interior side panel 52b. Panels 50b and 52b extend between upper edge 40a and lower edge 40b and also between a front edge 40c and an opposing back edge 40d. Panels 50b and 52b are connected together at upper edge 40a and bound a pocket 54b therebetween. A front opening 56b to pocket 54b is formed along front edge 40c while a back opening 58b to pocket 54b is formed along back edge 40d.
As will be discussed below in greater detail, a product retainer 60 can be disposed within compartment 24 for use in supporting a drug product or trial product therein.
As also shown in
It is noted that between adjacent elements of zipper carton 10a where one element is designed to be folded relative to the other, such as between adjacent panels or between a panel and an adjacent tab or flap, a crease is formed in the sheet material used to form zipper carton 10a so as to enable easy, smooth and straight folding between the elements. The crease is typically formed by compression, such as by pressing a platen or die against the sheet material so that the sheet material at the crease is more compressed and thinner than the adjacent material. A score line can also be used to form a crease. For example, a crease 62b is formed at the intersection between cover panel 64 and rear panel 36 while creases 62c and 62d are formed at the intersection between cover panel 64 and dust flaps 66 and 68, respectively.
Cover panel 64 is sized and configured to cover access opening 30 of compartment 24. More specifically, when moving zipper carton 10a from an open position, as shown in
As shown in
Locking tab 72 comprises a base 82 having a front edge 82a and an opposing back edge 82b that extend between opposing side edges 82c and 82d. Back edge 82b connects to zipper tear strip 74. Base 82 also has a front face 98 and an opposing back face 99 (
Returning to
Returning to
By use of locking panel assembly 16, zipper carton 10a can be selectively and manually moved between an open position, a closed position, and a closed, locked position. In the open position, as shown in
To move zipper carton 10a to the closed position or the closed/locked position, dust flaps 66 and 68 are folded inward along creases 62c and 62d, respectively. As previously discussed, cover panel 64 is then folded forward along crease 62b to cover access opening 30 while dust flaps 66 and 68 are received within compartment 24, as shown in
Next, tuck flaps 76 and 78 of locking panel assembly 16 are inwardly folded along creases 62e and 62f, respectively, so that tuck flaps 76 and 78 are generally perpendicular to extension panel 70. Locking panel assembly 16 is then folded forward along crease 62a so that tuck flaps 76 and 78 are received within pockets 54a and 54b, respectively, as shown in
Inserting tuck flaps 76 and 78 within pockets 54 holds zipper carton 10a in a closed position where access opening 30 is covered. However, zipper carton 10a can be moved back to the open position by simply reversing the above steps.
To move zipper carton 10a to the closed and locked position, locking tab 72, as shown in
When moved to a folded position, each of retention flaps 84, 86, and 88 is manually folded relative to base 82 so that if manually released, retention flaps 84, 86, and 88 automatically resiliently rebound back toward the relaxed position, i.e., rebound to a rebound position. This resilient rebounding of retention flaps 84, 86, and 88 is a result of the properties of the material used to make zipper carton 10a and, more specifically, locking panel assembly 16. As will be discussed below in more detail, zipper carton 10a is formed from a flexible sheet of material having properties that enables resilient rebounding of retention flaps 84, 86, and 88 as discussed herein.
In one method of collapsing locking tab 72, retention flaps 84, 86, and 88 are moved from the relaxed position to the folded position by first folding third retention flap 88 so as to be disposed against or adjacent to front face 98 (
Finally, while manually holding locking tab 72 in the collapsed position, locking panel assembly 16 is folded flush against front panel 34 of carton body 12/encircling sidewall 18 while collapsed locking tab 72 is slid or passed through slot 41 and into compartment 24. As collapsed locking tab 72 is advanced into slot 41, retention flaps 84, 86, and 88 are released allowing them to automatically rebound within compartment 24 behind front panel 34 to the rebound position, i.e., back toward the relaxed position. The extent that retention flaps 84, 86, and 88 rebound back toward the relaxed position is primarily dependent upon the material used to make locking panel assembly 16. However, retention flaps 84, 86, and 88 will typically rebound at least 30°, 50°, 70° or 90°. Because retention flaps 84, 86, and 88 rebound away from base 82, retention flaps 84, 86, and 88 block and prevent locking tab 72 from being pulled out of slot 41. For example, as depicted in
With reference to
Folding third retention flap 88 first against base 82 and then folding retention flaps 84 and 86 on top of retention flap 88 has multiple advantages. First, in this configuration, the rebounding of retention flap 88 assists in the rebounding of retention flaps 84 and 86. Furthermore, by retention flap 88 rebounding to the extent shown in
With retention flaps 84, 86, and 88 in the rebounded position, zipper carton 10a is in a closed and locked position. That is, access opening 30 is covered and zipper carton 10a cannot be moved back to the open position, where access opening 30 is uncovered, without cutting, tearing or other destruction of a portion of zipper carton 10a. For example, manually pulling locking tab 72 out of slot 41 would result in tearing retention flaps 84 and 86 fully, or at least partially, from base 82. Such tearing would provide visual indication that zipper carton 10a has been opened and would preclude the reclosing and locking of zipper carton 10a. It is also noted that when zipper carton 10a is in the closed and locked position that all of the opposing walls are tightly held together in a close tolerance so that any drug product or trial product disposed within compartment 24 can typically not be seen and/or cannot be removed from compartment 24 without some visual destruction of zipper carton 10a.
When it is desired to open zipper carton 10a, as shown in
The above discussion of zipper carton 10a is one configuration and one method of use. It is appreciated, however, that zipper carton 10a can be used in a variety of different ways and can have a variety of different configurations. For example, depicted in
Zipper carton 10b can be moved between an open position, similar to that shown in
When locking tab 72′ is in the collapsed position, locking tab 72′ is slide within slot 41. Retention flaps 84 and 86 then automatically rebound to a rebound position so as to prevent locking tab 72′ from being pulled out of slot 41, thereby securing zipper carton 10b in the closed and locked position. When desired, zipper carton 10b can be moved to an open position by removal of zipper tear strip 74, as previously discussed.
Depicted in
Zipper tear strip 74 has also been shortened in zipper carton 10d so as to only extend along the length of front edge 64A of cover panel 64. As such, notch 59 (
Turning to
It is appreciated that different elements between zipper cartons 10a-10e can be freely mixed and matched. For example, locking tab 72 of zipper cartons 10d and 10e can be replaced with locking tab 72′ or 72″, of zipper cartons 10b and 10c.
Zipper carton 10a and the alternative embodiments thereof can be formed in a variety of different ways and can be formed so that carton body 12 has a variety of different configurations. Depicted in
Template 110a typically comprises a single, continuous, unitary structure. That is, template 110a is typically cut or otherwise formed from one continuous sheet of material as opposed to being formed from two or more separate pieces of a sheet of material that are later connected together, such as by crimping, welding, mechanical connection, adhesive connection or the like. However, in other embodiments, template 110a can be formed from two or more pieces of a sheet of material that are connected by crimping, welding, mechanical connection, adhesive connection, or the like. This latter embodiment, however, is typically less efficient since it is more complicated to produce.
The sheet of material can comprise a paper-based material, such as paper, cardstock, paperboard or cardboard. In other embodiments, the sheet of material can be comprised of a synthetic, plastic, or other material (e.g., adapted to retain a crease when folded and produce the resilient rebounding discussed herein). The sheet of material can comprise a composite, a laminate, an extrusion, or a base sheet having a coating on one or both opposing sides thereof. Template 110a/sheet of material can have a thickness suitable for various embodiments of zipper carton 10a. For instance, template 110a typically has a thickness of at least 0.3 mm, 0.4 mm, 0.5 mm, 0.8 mm 1 mm, 1.2 mm, 1.5, 2 mm 2.5 mm or in a range between any two of the foregoing. The sheet of material selected to form template 110a and the zipper cartons discussed herein can be selected so that the various retention flaps discussed herein produced the discussed resilient rebounding. The extent of the resilient rebounding produced by a sheet can be a factor of thickness, density, stiffness and/or composition of the sheet/paper. Whether a sheet, such as a sheet of paper material, achieves the desired functional properties can be determined through empirical testing. In one embodiment, the templates and zipper cartons disclosed herein can be produced having desired functional properties by being formed from solid bleached board (SBB) or solid bleached sulphate (SBS) paperboard having a thickness in a range between 0.4 mm and 0.8 mm and more commonly between 0.5 mm and 0.7 mm. In one embodiment, the paperboard can have a mineral or synthetic pigment coating on one side or both opposing sides. In another alternative embodiment, the templates and zipper cartons disclosed herein can be produced having desired functional properties by being formed from an E-flute corrugated cardboard having a thickness in a range between 1 mm and 2 mm with between 1.3 mm and 1.7 mm being more common. Other materials can also be used.
Continuing with
First side panel 38 includes exterior side panel 50a and interior side panel 52a with a crease 112i formed therebetween. A tab 120a outwardly projects from the free end of exterior side panel 50a and is configured to be received within cut slit 114a. Similarly, second side panel 40 includes exterior side panel 50b and interior side panel 52b with a crease 112j formed therebetween. A tab 120b outwardly project from the free end of exterior side panel 50b and is configured to be received within cut slit 114b.
Template 110a also includes product retainer 60. Product retainer 60 includes a support panel 124 having a front edge 124a, an opposing back edge 124b and opposing side edges 124c and 124d. An extension panel 126 extends from back edge 126b to upper edge 34a of front panel 34. A crease 112k is formed at the intersection of extension panel 126 and front panel 34 while a crease 112l is formed at the intersection of extension panel 126 and support panel 124. Support flaps 128a, 128b, and 128c project from front edge 124a, side edge 124c and side edge 124d of support panel 124, respectively, while creases 112m, 112n, and 112o are formed at the intersections thereof, respectively. Support panel 124 has an opening 130 centrally extending therethrough and includes a plurality of flexible brace flaps 132 that encircle opening 130. Finally, cover panel assembly 14 and locking panel assembly 16 are connected to rear panel 36 as previously discussed.
A method of erecting template 110a, shown in
Next, with reference to
One method will now be discussed as to how zipper carton 10a can be used for loading, delivering and dispensing a drug product or trial products for use in a blinded trial. Once flat templates 110a are obtained, they can be manipulated into the erected open position as discussed above and depicted in
With continued reference to
It is also noted that central projection 94 of retention flap 88 is designed to assist in the positioning of retention flap 88 between retention flaps 84 and 86. Specifically, when locking tab 72 is in the collapsed position and is initially being inserted into slot 41 (
Thus, folding retention flaps 84, 86, and 88 toward front face 98 of base 82 (
The size and configuration of product retainer 60 can vary based upon the size, configuration and type of drug product/trial product 136 to be housed therein. As previously discussed, in at least one embodiment, trial product 136 can comprise one or more different products. For example, trial product 136 can comprise a test product that can comprise an active drug product, a comparator product, a control product, a placebo product, or one or more combinations of the foregoing. Furthermore, in different zipper cartons or in the same zipper carton, the drug product or the trial product, i.e., the active drug product, comparator product, control product, and/or placebo product, can be provided in different quantities, volumes, concentrations, strengths, types (i.e., pill, ointment, liquid, injection, etc.) or combinations of the foregoing. Furthermore, in at least one embodiment, drug product/trial product 136 can include multiple dosages or concentrations of one or more different drug products/trial products 136. Accordingly, drug product/trial product 136 can comprise a plurality of different containers and different container types being placed in the same or different zipper cartons. Depending on the form of the drug being tested, the foregoing products may be housed in pill bottles, syringes, vials, tubes or other conventional containers. For example, in
Materials inserted with drug product/trial product 136 into opening 130 can also include one or more support products such as antiseptics, band-aids, swabs, gauze, tape, instructions, disposal containers or any other accessories that may be used or associated with the drug being used or tested. Drug product/trial product 136 can be held securely within compartment 24, such as by using product retainer 60. Alternatively, product retainer 60 can be eliminated and drug product/trial product 136 and the support products can be loosely held within compartment 24.
Once drug product/trial product 136 has been properly packed within zipper carton 10a, zipper carton 10a can then be manipulated from the erected, opened position, illustrated in
By moving zipper carton 10a to the closed and locked position, zipper carton 10a/compartment 24 becomes sealed closed so that drug product/trial product 136 cannot be seen, accessed and/or tampered with until zipper carton 10a is opened by the removal of zipper tear strip 74.
Either prior to, during, or after loading of drug product/trial product 136 in zipper carton 10a, one or more labels can be secured on the exterior and/or interior surface of zipper carton 10a. The labels can provide instructions, identification indicia, or other relevant information for the blinded trial or use of the drug product. Once zipper carton 10a is sealed closed, zipper carton 10a can be packaged with other zipper cartons 10 for transporting as a group or can be individually transported to a first recipient. For example, where the product is a drug product, the first recipient can be a retail store, hospital, clinic, end user, or the like. Where the product is a trial product, the first recipient may be a medical practitioner such as an administering technician or doctor. The technician/doctor can open zipper carton 10a by removing zipper tear strip 74 and administer the trial product 136 or deliver the zipper carton 10a to a second recipient for administration of the trial product 136.
In certain embodiments, filled, closed, and locked zipper cartons 10a can be distributed to a hospital or clinic where they can be distributed to patients either directly on site or for the patient to take home for self-administration. It will also be noted that steps of erecting zipper carton 10a, inserting drug products/trial product 136 therein, closing zipper carton 10a, locking zipper carton 10a, and labeling zipper carton 10a can be accomplished by up to five separate people. In at least one embodiment, however, a plurality of said steps is performed by the same person. For instance, in at least one embodiment, each of the foregoing steps is performed by the same person.
The locked zipper carton 10a is typically opened by an intended recipient, such as an administering technician of the medical practice participating in the trial or the patient receiving the dosage thereof or the end user of a drug product. As previously discussed and depicted in
Once zipper tear strip 74 is removed, extension panel 70 can be raised so as to withdraw tuck flaps 76 and 78 from pockets 54a and 54b, respectively. Cover panel 64 can then be raised so as to withdraw dust flaps 66 and 68 from compartment 24 and thereby provide open access to drug product/trial products 136 within compartment 24 through access opening 30, as shown in
It will be appreciated that zipper carton 10a can be reclosed, i.e., moved back to the closed position, by reversing the foregoing steps involving dust flaps 66 and 68, cover panel 64, and tuck flaps 76 and 78. However, because locking tab 72 has been removed by the removal of zipper tear strip 74, zipper carton 10a cannot be moved back to the closed and locked position. However, as discussed below, a reseal panel can be attached to zipper carton 10a to enabling closing and locking of zipper carton 10a.
It is appreciated that zipper carton 10a can have a variety of different sizes and shapes depending upon the size, shape, type, and number of drug products/trial products to be housed therein. For example, the final fully assembled and closed carton body 12 can have a box shaped configuration, i.e., a parallelepiped hexahedron, having square or rectangular panels. Accordingly, with reference to
Depicted in
As depicted in
In this assembled configuration, reseal panel 150 now overlies where locking panel assembly 16 (
Collapsed primary locking tab 72 can then be advanced into slot 41 while tuck flaps 76 and 78 are being advanced into pockets 54, as shown in
It is appreciated that reseal panel 150 can come in a variety of different configurations. For example, primary locking tab 72 can be replaced with locking tab 72′ or 72″, previously discussed, and the different retention flaps thereof can be folded in either direction. Likewise, secondary locking tab 72′ can be replaced with locking tab 72 or 72″, previously discussed, and the different retention flaps thereof can be folded in either direction. Furthermore, as with locking panel assembly of zipper carton 10d, discussed and shown with regard to
It is appreciated that the disclosed zipper cartons and reseal panels and the related methods of assembly and use have unique advantages and benefits over the prior art. For example, embodiments of the disclosed zipper carton and reseal panel are simple and inexpensive to produce, easily erected, and environmentally friendly. This is especially true where the zipper carton and reseal panel are each made from single piece template comprised of a paper product. Such zipper cartons and reseal panels avoid the need for making and assembling multiple different part.
Embodiments of the zipper carton are also unique in that no adhesive is applied to the template during manufacture of the template, thereby reducing cost, complexity and environmental concerns. In addition, no adhesive is needed to erect, close or lock the zipper cartons. An adhesive can be in the form of a tape, sticker, or independent adhesive. Eliminating adhesive from the zipper cartons simplifies use of the zipper cartons, eliminates risk or damage resulting from failure of the adhesive, such a failure of the adhesive due to freezing, limits waste since removable cover strips are no longer needed to be placed over the adhesive layer, and makes disposable of the zipper carton more environmentally friendly. The same benefits also apply to the reseal panels that require no adhesive to be applied during manufacture and no use of adhesive during use.
Embodiments of the zipper carton, with our without the reseal panel, are also unique in that they can be closed and locked without the required use of a tool or machine. Furthermore, once the zipper cartons are locked, they can be difficult if not impossible to open without removal of the zipper tear strip or destroying part of the carton. As such, the zipper cartons are an effective tamper evident carton. That is, they provide a clear indication when a carton has been opened and can produce clear indications as to when attempts have been made to open the carton. The zipper cartons also completely and securely shield the trial product so as to eliminate any ability to inspect the trial product within the locked zipper carton.
Embodiments of the zipper cartons, with or without the reseal panel, are also unique in that the erected, closed and locked zipper cartons consistently having identical configurations, thereby improving the integrity of the related blinded studies. In contrast, cartons closed by adhesive can often have discrepancies between cartons that can lead to actual or implied assumptions as to the trial product contained therein.
Various alterations and/or modifications of the inventive features illustrated herein, and additional applications of the principles illustrated herein, which would occur to one skilled in the relevant art and having possession of this disclosure, can be made to the illustrated embodiments without departing from the spirit and scope of the invention as defined by the claims, and are to be considered within the scope of this disclosure. Thus, while various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. While a number of methods and components similar or equivalent to those described herein can be used to practice embodiments of the present disclosure, only certain components and methods are described herein.
It will also be appreciated that systems, processes, and/or products according to certain embodiments of the present disclosure may include, incorporate, or otherwise comprise properties features (e.g., components, members, elements, parts, and/or portions) described in other embodiments disclosed and/or described herein. Accordingly, the various features of certain embodiments can be compatible with, combined with, included in, and/or incorporated into other embodiments of the present disclosure. Thus, disclosure of certain features relative to a specific embodiment of the present disclosure should not be construed as limiting application or inclusion of said features to the specific embodiment. Rather, it will be appreciated that other embodiments can also include said features without necessarily departing from the scope of the present disclosure.
Moreover, unless a feature is described as requiring another feature in combination therewith, any feature herein may be combined with any other feature of a same or different embodiment disclosed herein. Furthermore, various well-known aspects of illustrative systems, processes, products, and the like are not described herein in particular detail in order to avoid obscuring aspects of the example embodiments. Such aspects are, however, also contemplated herein.
The present disclosure may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. While certain embodiments and details have been included herein and in the attached disclosure for purposes of illustrating embodiments of the present disclosure, it will be apparent to those skilled in the art that various changes in the methods, products, devices, and apparatus disclosed herein may be made without departing from the scope of the disclosure or of the invention, which is defined in the appended claims. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.
This application claims the benefit of Provisional Application No. 62/860,099, filed Jun. 11, 2019, which is incorporated herein by specific reference.
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