|Publication number||US20070251983 A1|
|Application number||US 10/595,714|
|Publication date||Nov 1, 2007|
|Filing date||Nov 12, 2004|
|Priority date||Nov 13, 2003|
|Also published as||CA2545797A1, CN1902098A, EP1687211A1, WO2005049438A1|
|Publication number||10595714, 595714, PCT/2004/38405, PCT/US/2004/038405, PCT/US/2004/38405, PCT/US/4/038405, PCT/US/4/38405, PCT/US2004/038405, PCT/US2004/38405, PCT/US2004038405, PCT/US200438405, PCT/US4/038405, PCT/US4/38405, PCT/US4038405, PCT/US438405, US 2007/0251983 A1, US 2007/251983 A1, US 20070251983 A1, US 20070251983A1, US 2007251983 A1, US 2007251983A1, US-A1-20070251983, US-A1-2007251983, US2007/0251983A1, US2007/251983A1, US20070251983 A1, US20070251983A1, US2007251983 A1, US2007251983A1|
|Original Assignee||Timothy Freeze|
|Export Citation||BiBTeX, EndNote, RefMan|
|Referenced by (11), Classifications (16), Legal Events (1)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application claims priority to co-pending U.S. Provisional application 60/520,143, filed on Nov. 13, 2003. The entire disclosure of that prior filed application is hereby incorporated by reference.
This invention relates to a package that houses portable items on a tray configured to be inserted into an outer sleeve. This package may have one or more internal or external locks that prevent the tray from being pulled out of the sleeve. This package provides a child-resistant, senior-friendly package that can be opened and closed numerous times to access the items held by the tray.
Conventional pharmaceutical packaging has shortcomings with regard to drug delivery devices, which create problems for both the manufacturer and end user. For example, it is known to distribute syringes, vials, inhalers, patches, test kits, or parts thereof in packaging that incorporates foam elements to separate and pad the product. Such conventional packaging normally holds the product in a vertical position; however, where conventional packaging holds the product in a horizontal position, the products are typically layered on top of each other. It is also known to distribute drug delivery devices loose—or loose, but individually wrapped—in conventional boxes without any means for holding or protecting the products.
The conventional manufacturer that incorporates form or plastic elements in its packaging to protect the product carries an increased inventory and employs a more complicated manufacturing system to produce its packaging. Further, the conventional manufacturer typically produces one kind of package to be filled by automated means and another kind to be filled by hand, which also increases inventory and the number of product lines.
Conventional manufacturers of drug delivery device packaging typically do not provide a child-resistant feature to prevent unauthorized access, or a stopping feature to prevent accidental spillage. Where these features do exist, they exist at the expense of easy access for the end user with limited dexterity. Neither does the known drug delivery device packaging provide ample space to place appropriately sized graphics, such as dose compliance instruction and warnings, for the end user with limited sight.
In addition, conventional manufacturers pack drug delivery devices tightly and in the most efficient manner possible—from the perspective of shipping cost savings—but, again, at the expense of the end user who has limited physical mobility, such as an end user with arthritis of the hands and fingers. Also conventional manufacturers are known to distribute only wholly-assembled drug delivery devices together, or parts of devices together, but not whole devices and parts together. For example, it is known to distribute syringes together or vials together on the same platform, but not syringes and vials together on the same platform.
End users are familiar with the disposal problems created by the use of drug delivery devices. Typically, spent patches, vials, needles, inhalers, syringes, barrels, and other devices or parts thereof should be sealed or otherwise protected in order to be disposed of safely. While it is known to dispose of syringes and needles in a separate device, such as a sealed plastic container, there remains a need for a drug delivery device packaging that also serves as a safe means of disposal.
It is apparent from a survey of the packaging arts that there exists a need for an apparatus that holds and protects all types of drug delivery devices and parts thereof, allows for improved manufacturing process, includes child-resistant and spill-prevention features, stores a variety of objects in response to the end users' needs, is fitted for easy access by the end user with limited dexterity, has sufficient area to receive graphics, and provides a means for safe disposal.
The present invention fulfills the needs identified above by providing packaging comprising an inner slide card/tray that is inserted within an outer sleeve. In some embodiments, the outer sleeve and inner slide card/tray both comprise elements configured to cooperatively engage the other to create a means for locking, means for releasing, and means for stopping.
In exemplary embodiments, the means for engaging include panels, tabs, catches, ribs, catches, abutments, edges, cutouts, apertures, and like elements, integral to or attached to either the card or tray, configured to connect with similar elements associated with the outer sleeve, and referred to herein as the means for locking. The means for releasing include panels, tabs, ribs, abutments, edges, cutouts, catches, apertures, and like elements, integral to or attached to the outer sleeve, configured to uncouple engaged or locked elements. Thus, the present invention provides an optional child-resistant feature. A means for stopping comprise panels, tabs, ribs, catches, abutments, apertures, edges, cutouts, and like elements, integral to or attached to either the card or tray, configured to matingly engage similar elements associated with the outer sleeve. Thus, the present invention provides an optional spill-resistant feature to prevent the user from pulling the tray completely away from the outer sleeve.
Alternative embodiments include an apparatus and method for holding and storing drug delivery devices by providing an inner tray configuration that, by way of example and not limitation, protects a plunger from inadvertent activation; shields a needle from inadvertent exposure; allows easy access to a drug-filled container for removal and replacement; and collects and stores the spent devices. Accordingly, embodiments of the present invention provide an apparatus and system that is able to safely ship drug delivery devices for trans-epidermal, oral, or hypodermic administration, including pre-filled syringes, needles, vials, ampoules, protective shields, patches, inhalers, and parts thereof, and like devices, safely store the unused devices, and safely store the used devices until all can be safely disposed as unit.
Embodiments include a pre-formed tray attached to a paperboard card, and a monolithically formed card/tray combination. Compliance information or general information related to the medication or therapy may be positioned on or with the slide card, tray, or outer sleeve in a manner easily visible by the user. In one embodiment, indicia—such as, but not limited to, time of day, days of the week, numerical sequence, or dosage amounts—are positioned adjacent to the devices.
Another embodiment of the present invention comprises a slide card with an engaging tab and a tray receiving area. At least one pre-formed tray, configured to receive and hold at least one portable item, may be attached to the tray receiving area. An outer sleeve that receives the card and attached tray comprises a locking edge configured to engage the tab at a locking position. The outer sleeve also has an integral release configured to disengage the tab from the locking position. Yet another embodiment of the present invention includes a slide card constructed of one material, with a base panel and a tray receiving area located on the base panel. A pre-formed tray constructed of a different material, with at least one receiving recess, is attached to the card at the tray receiving area. Both may be fully inserted within a void defined by an outer sleeve, through an open end of the sleeve. Another embodiment of the present invention is defined by a slide card and outer sleeve combination. Here the side card comprises a means for engaging and at least one tray receiving area, together with a pre-formed tray configured to receive and hold at least one portable item, attached to the tray receiving area. Here the outer sleeve defines a void configured to receive the card and attached tray, and comprises a means for locking the card's means for engaging. The outer sleeve also includes an integral means for releasing configured to uncouple the means for engaging from the means for locking.
Other embodiments of the present invention include improved components, such as a monolithically fabricated tray with card. Here, a tray with card may be fabricated from any forming technique or process known to those skilled in the art, including but not limited to thermo-forming, vacuum forming, and injection molding. The tray with card includes an engaging panel hingedly attached to a second panel or the integral tray. The tray comprises at least one recess configured to receive and hold a portable item. A third panel, configured to fold over and cover the item(s) in the tray, may likewise be hingedly attached to either the second panel or tray. This improved component is configured to be inserted into an outer sleeve.
In practice, some embodiments of the present invention are configured to resist access to an item by securing the item in a lockable package. A method for resisting access to an item secured in an embodiment of the present invention comprises the following steps, presented in the following order for the purposes of teaching and not limitation. Provide a slide card with a means for engagement and a base panel. Attach a pre-formed tray comprising at least one receiving recess to the base panel and place an item in the recess. Provide an outer sleeve with an open end, an accessible void, and a means for locking the card. Align the card with the open end and orientate the means for engagement with the means for locking. Insert the card fully into the void to cause the means for engaging and means for locking to releaseably couple or connect.
Embodiments according to this invention offer at least the following advantages: lightness in weight, resistance to tampering, child-resistance, ease of access, excellent durability, ease of assembly, device protection, ease of storage, ease of disposal, the ability to present devices of different and unusual shapes, and excellent economy.
It is also contemplated that the present invention is not limited to pharmaceutical-related goods, but is applicable to a plethora of delicate, sensitive, or unique portable goods. Small electronic components, jewelry, foods, expensive and precious articles, and any other item that requires a safe, stable, and portable environment in which to be shipped and stored may find an application with the present invention. Other advantages of the present invention will be apparent from the following description, the accompanying drawings, and the appended claims.
As required, detailed embodiments of the present invention are disclosed herein. It will be understood that the disclosed embodiments are merely exemplary of the invention that may be embodied in various and alternative forms. The figures are not necessarily to scale, and some features may be exaggerated or minimized to show details of particular components. In other instances, well-known materials or methods have not been described in detail in order to avoid obscuring the present invention. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but as a basis for the claims and for teaching one skilled in the art to variously employ the present invention.
Referring now to the drawings, wherein like numerals represent like features throughout, there are illustrated embodiments of the present invention. Turning first to
Herein, the phrase “drug delivery devices” is used broadly to refer to all apparatus and parts thereof used in conjunction with transferring substances into or out of a body, such as but not limited to a human being. By way of example and not limitation, a drug delivery device comprises a substance in the form of, or contained within, pills, tablets, chewables, aerosols, inhalers, trans-dermal patches, suppositories, injectable devices, parts thereof, and the like. Injectable devices comprise a plunger, barrel, and needle used by a medical professional to treat a patient with a pharmaceutical drug, or the patient to treat him or herself. For purposes of teaching and not limitation, the illustrated tray embodiments are directed to drug delivery devices in the form of injectable devices, but those skilled in the art will immediately understand that the tray may be configured to hold any portable item.
As best shown in
With regard to choice of materials, the slide card 10 may comprise paper, paperboard, cardboard, plastic, or combinations thereof. Where the slide card 10 comprises paperboard, bleached sulphate, solid unbleached sulphate, or clay-coated newsback are well-known design choices. Typically the paperboard coating is a fluid blend of materials, such as coating clay, calcium carbonate, and/or titanium dioxide with starch or adhesive smoothly applied to the traveling surface. Successive densification and polishing finish the mineral-coated surface to a superior, graphic-print surface. When the card and/or tray is paper, fabrication techniques well known to those skilled in the art, including vacuum forming, are contemplated. When the card and/or tray is plastic, fabrication techniques well known to those skilled in the art, including thermo-forming, injection molding, and the like, are contemplated. Where the slide card 10 is plastic, the fold-lines 24 a, b may be live hinges, or, as explained below regarding the engaging feature of the tab 22, fold-line 24 b may be a formed hinge with an upwardly or downwardly extending profile to create an internal spring tension that urges the tab 22 back toward a relatively relaxed or horizontal orientation when the tab 22 is first folded over toward base panel 16.
The tray 26 is configured to receive and store items of substantially uniform shape and size, such as the illustrated syringe 32 comprising a plunger 34, barrel 36, finger guard 38, and needle 40. The tray 26 comprises a means for securing and holding the syringe 32, such as the plunger-receiving recess 42, barrel-receiving recess 44, and needle-receiving recess 46. The recesses 42, 44, 46 may be configured to lock in or otherwise secure the item by including a means for resisting removal such as fold-over locking flaps, indentions, straps, inserts, and the like (not shown). Accordingly, a means for holding and storing a drug delivery device includes a pre-formed tray that can be configured in a variety of ways.
Regarding the illustrated embodiments, in practice the tray 12, 26 is pre-formed separately and then affixed to the card 10 at the tray receiving area 14, the location being merely a design choice. An alternative embodiment that is not illustrated comprises a monolithically formed card/tray combination. There it is contemplated that the slide card 10 is an integral part of the tray 12, 26, the two components being formed as a single unit during fabrication.
The tray 12 is configured to receive and store items of substantially unique shapes and sizes, such as the vial 30 and syringe 32. Thus, tray 12 comprises a means for securing and holding the vial 30, such as the vial-receiving recess 48, and a means for securing and holding the syringe 32 as described immediately above. The recess 48 may be configured to lock in or otherwise secure the item by including a means for resisting removal such as fold-over locking flaps, indentions, straps, inserts, and the like (not shown). As understood by one skilled in the art, the various recesses illustrated herein may be configured to receive and store any portable items of any shape or size.
Here the trays 12, 26 are also configured to allow for easy access to the items. By way of illustration and not limitation, the devices are arranged so that the end user, who may have limited physical mobility such as arthritis, can retrieve one device without affecting another. As illustrated, orienting the widest portion of the syringe 32—in this example, the finger guard 38—to take the most space to provide the greatest accessibility is a desirable feature of this embodiment. Such horizontal orienting also provides easy viewing of the devices so the user may easily distinguish between them. Further, such orienting provides ample area to receive graphics. For example, dosage regimen instructions including date, day, and time may be formed on the tray sections between or adjacent to the recesses. Alternatively, the items held on the tray may be as closely packed and aligned as desired.
Patient and healthcare provider information, such as dose compliance, warnings, and instructions in written form or digital form can be made easily visible or accessible to the user through the ample billboard space found on either side of the panels 16, 20, tab 22, or the components described below.
Turning now to
Side panel 104 comprises release button 130, defined by release button cut 132 and release button fold-line 134. Side panel 108 comprises a first engaging tab cutout 140 defined by cut-line 142, and a second engaging tab cutout 144 defined by cut-line 146. Side panels 104 and 106 further comprise access cutouts 148. As explained below, first engaging tab cutout 140 and engaging tab 22 together form an embodiment of a means for locking, while second engaging tab cutout 144 and engaging tab 22 together form an embodiment of a means for stopping.
With regard to assembly, the blank 102 is folded and connected using conventional techniques to create the outer sleeve 100, best shown in
Generally speaking, items are placed within inner tray 12, 26 and then the combined card 10 and tray 12, 26 is inserted into the void 150 of outer sleeve 100. In the example of drug delivery devices holding unit doses, the illustrated Unit Dose Packaging System (UDPS) secures these devices until they are retrieved for use. In practice, items are placed within the inner tray 12, 26 and then the various panels and tabs are folded before the combined card 10 and tray 12, 26 is inserted into the outer sleeve 100. For purposes of teaching and not limitation, the following folding sequence is described. Top panel 20 is folded so as to cover the tray 12, 26 and orient the spine panel 18 adjacent to a side of the tray. Tab 22 is folded inwardly so that the face of tab 22 is proximate to the face of base panel 16. With the card 10 folded as described, the combined card 10 and tray 12, 26 is inserted into the void 150 of outer sleeve 100 through the open end, starting with the edge formed by fold-line 24 b and with the tab 22 receivingly aligned with release button 130, as illustrated in
With continued reference to
In the illustrated embodiment the locking feature includes the release button 130, cutout 140, and cooperatively engaging tab 22. The spring tension created by the folded tab 22 causes the tab edge 154 to engage the internal edge 156 of cutout 140. With the tab 22 and internal edge 156 engaged, the inner tray 12, 26 is locked within the outer sleeve 100 and cannot be accessed. This means for locking creates a child-resistant feature. As illustrated, internal edge 156 has a semi-circular convex profile that engages well with the semi-circular convex profile of tab edge 154. To unlock the child-resistant feature of this embodiment and thereby access the tray 12, 26, the user depresses the release button 130, which in turn depresses the tab 22 to disengage the tab edge 154 from the internal edge 156.
After releasing the optional child-resistant feature the inner card 10 may be extracted from the outer sleeve 100 to a fully open position. In the illustrated embodiments, a fully open position occurs when tab 22 engages the interior of folded extension panel 120 at stopping position B. As will be understood by those skilled in the art, the spring tension created by the folded tab 22 causes the tab 22 to engage the folded interior of the extension panel 120. Once engaged, the card 10 cannot be further removed from the outer sleeve 100 but may be re-inserted to a fully closed position if desired. In this manner, tab 22 acts as a spill-resistant feature to prevent inner card 10 from being pulled completely out of sleeve 100.
It will be understood that a means for locking and a means for stopping are contemplated in various embodiments. For example, in the illustrated embodiment the extension panel 120 is not attached to side panel 108, but is allowed to extend downwardly into the void 150 to catch and engage the folded tab 22 as the card 10 is removed from the sleeve 100, thereby forming a means for stopping. In an alternative embodiment the extension panel 120 is folded inwardly and the respective backs of the panels 120, 108 are attached so that the extension panel edge 152 abuts tab edge 154, thereby forming a means for stopping. In the illustrated embodiment the first cutout 140 and the engaging tab 22 have a similar profile, which facilitates engagement of the respective edges 154, 156 and forms a means for locking. In alternative embodiments any edge or protrusion within the void 150 configured from panels, tabs, cutouts, ribs, offsets, catches, apertures, abutments, edges, and like elements, that engage the tab 22 or tab edge 154, forms an alternative means for locking or an alternative means for stopping. In yet another embodiment, tab 22 or edge 154 is connected to the tray 12, 26 to create a means for locking and a means for stopping.
The user may open and close the UDPS by withdrawing and replacing the inner tray 12, 26 within the outer sleeve 100 as often as desired. Regarding the illustrated embodiments, from the fully closed position the user grasps the card 10 at the top panel 20 and bottom panel 16, adjacent to the spine panel 18, from the access cutouts 148 provided in side panels 104, 106. The user then depresses the release button 130 in order to disengage the means for locking. Continuing to depress the button 130 while grasping and pulling laterally the card/tray will withdraw the tray 12, 26 from the sleeve 100. From the fully open position the user may fold back the optional top panel 20 to access an item held in the tray 12, 26. After accessing the desired item, the user folds the top panel 20 back over the tray 12, 26 and reinserts the card 10 within the sleeve 100 for future use.
An alternative embodiment (not shown) designed to be disposed of together with spent drug delivery devices, may be placed within a labeled plastic bag provided with the USPS thereby giving notice of its contents. By way of illustration and not limitation, additional means for protecting and sealing an embodiment that holds spent drug delivery devices until they can be disposed of together, include sealable bags, a self-sealing outer sleeve, a sealable outer sleeve large enough to receive the sleeve 100. Similarly, taping the inner tray within the sleeve with a labeled tape giving notice of the contents is a means for protecting and securing.
It is contemplated that the present invention is not limited to the pharmaceutical-related goods illustrated, but is applicable to a plethora of delicate, sensitive, or unique portable goods. By way of example and not limitation, small electronic components, jewelry, foods, expensive and precious articles, and any other item that requires a safe, stable, and portable environment in which to be shipped and stored may find an application with the present invention. Further, it will be understood that variations, modifications, and enhancements can be made to the disclosed apparatus and methods without departing from the scope of the present invention as defined in the following claims.
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US8066121||Sep 22, 2009||Nov 29, 2011||Anderson Packaging, Inc.||Child-resistant, senior-friendly package having a squeeze-release mechanism and method of assembly|
|US8359816||May 24, 2011||Jan 29, 2013||Juno Technologies, Llc||Apparatus for and method of shipping a child-resistant medicate container|
|US8458994 *||Sep 14, 2012||Jun 11, 2013||Juno Technologies, Llc||Method of shipping a child-resistant medicate container|
|US8499936 *||Mar 13, 2012||Aug 6, 2013||Nosco, Inc.||Product packaging system with button lock release|
|US8746444 *||Jan 25, 2008||Jun 10, 2014||Stora Enso Ab||Package and insert adapted to form part of a package|
|US8936158||Jan 12, 2012||Jan 20, 2015||Bby Solutions, Inc.||Product packaging with slide out tray|
|US20100236957 *||Jan 25, 2008||Sep 23, 2010||Marcus Dehlin||Package and insert adapted to form part of a package|
|US20120234701 *||Mar 13, 2012||Sep 20, 2012||Nosco, Inc.||Product packaging system with button lock release|
|US20150041339 *||Oct 22, 2014||Feb 12, 2015||Meadwestvaco Corporation||Outer sleeve and blank therefor|
|USD731309||Sep 18, 2013||Jun 9, 2015||Juno Technologies Llc||Medicate container|
|WO2013151806A1 *||Mar 22, 2013||Oct 10, 2013||Meadwestvaco Corporation||Lockable packaging|
|International Classification||A61M5/00, B65D5/50, B65D5/38|
|Cooperative Classification||A61M2205/276, B65D5/503, B65D2215/02, B65D2215/04, A61M5/003, A61J7/0069, A61M5/008, B65D5/38|
|European Classification||B65D5/50D1, A61M5/00P2, B65D5/38, A61J7/00E|
|Jun 1, 2006||AS||Assignment|
Owner name: MEADWESTVACO CORPORATION, CONNECTICUT
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:FREEZE, TIMOTHY;REEL/FRAME:017707/0084
Effective date: 20060531