Patent Application
20100147936
This invention relates to packaging, and more specifically to a two-piece apparatus that houses one or more drug delivery devices on an internal slide card within an outer shell. This apparatus may have one or more internal or external locks that prevent the slide card from being pulled out without triggering a related lock release.
Conventional pharmaceutical packaging has shortcomings with regard to injectables, which create problems for both the manufacturer and end user. For example, there is known to distribute syringes, vials, and parts thereof in packaging that incorporate foam or plastic elements to protect the product. Such conventional packaging normally holds the product in a vertical position. Where conventional packaging holds the product in a horizontal position, the products are typically stacked on top of each other. There is also known to distribute syringes, vials, and parts thereof loose-or loose, but individually wrapped-in conventional boxes without any means for holding or protecting the products.
The conventional manufacturer that incorporates foam 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 injectable holding 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 injectable packaging provide ample space to place appropriately sized graphics, such as dose compliance instructions and warnings, for the end user with limited sight.
In addition, conventional manufacturers pack injectables 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 fingers. Also conventional manufacturers are known to distribute only wholly-assembled syringes together, parts of syringes together, or vials together, but not whole syringes or parts or vials mixed together. This convention requires the end user to create and maintain an inventory of injectables to fill their individual needs.
End users are familiar with the disposal problems created by the use of injectables. Typically, spent vials, needles, syringes, barrels, and other injectables or parts thereof must be sealed or otherwise protected in order to be disposed of safely. While it is known to dispose of injectables in a separate device, such as a sealable plastic container, there remains a need for an injectable packaging that also serves as a safe means of disposal.
It is apparent from a survey of the pharmaceutical 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 processes, 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 who has limited dexterity, has sufficient area to receive graphics, and provides a means for safe disposal.
Generally speaking, the present invention fulfills the needs identified above by providing packaging embodiments comprising an outer sleeve and an inner slide card retained within the outer sleeve and with embodiments that releaseably lock the inner slide card within the outer sleeve. In lockable embodiments, the outer sleeve includes at least one panel with an inner slide card means for locking, an inner slide card means for releasing, and an optional inner slide card means for stopping. The inner slide card includes a tray and at least one panel configured to cooperatively engage the outer sleeve means for locking, means for releasing, and optional means for stopping.
In exemplary embodiments the inner slide card means for locking include extension panels or tabs integral to the inner card or, optionally, attachments extending therefrom, configured to releasably engage the outer sleeve. Also the inner card means for releasing includes a catch and a release on an outer sleeve panel, or an attachment extending therefrom, configured to releasably engage said means for locking. The inner slide card means for locking or retaining comprises inner card and outer sleeve extension panels or tabs configured to engage, or attachments or catches associated with the card and sleeve that are configured to engage. Thus the present invention provides an optional child-resistant feature.
In exemplary embodiments, the inner card means for stopping comprises inner card and outer sleeve extension panels or tabs configured to engage, or attachments or catches associated with the card and sleeve that are configured to engage. Thus the present invention provides an optional spill-resistant feature to prevent the user from pulling the inner card completely away from the outer sleeve, but which can be opened and closed numerous times to access the drug delivery devices.
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 transepidermal, oral, and hypodermic administration, including pre-filled syringes, needles, vials, ampoules, protective shields, and accessories, safely store the unused devices, and safely store the used devices until all can be safely disposed as a unit.
Alternative embodiments include an apparatus and method for providing compliance directions or information directed to therapy management. 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. In another embodiment, compliance information or general information related to the medication or therapy is positioned on or with the inner slide card or outer sleeve in a manner easily visible by the user.
Further embodiments include an apparatus for use with a high volume pick-and-pack manufacturing process. The same embodiments provide an apparatus for use with a hand pick-and-pack manufacturing process. Another embodiment includes an apparatus and method for protecting and storing spent drug delivery devices within a secure container until they can be disposed of in a controlled fashion.
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 articles. Small electronic components, jewelry, foods, expensive and precious goods, and any other item which 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
As best shown in
An extension panel 25 comprises an outside sidewall panel 26, top panel 28, inside sidewall panel 30, and securing panel 32. Further, panel 25 comprises a plunger-receiving slot 34, formed by cuts 23 and fold lines 24, and a needle-receiving aperture 36, 38. Alternative aperture designs are shown to illustrate a means for securing syringe ends with or without a protective cap. As understood by one skilled in the art, in certain embodiments the aperture 36 may be formed by cuts 23 in the form of an “X” while in other embodiments the aperture 38 may be formed by cuts 23 that create a void.
Blank 10 further includes locking tab 40 and stopping tabs 42. As described in detail below, locking tab 40 cooperatively engages with another element to create a child-resistant feature. Also as described below, stopping tabs 42 cooperatively engage with another element to create a pull-out stop that also functions as a spill-resistant feature. With the explanation below, one skilled in the art will understand that the child-resistance feature and stopping feature can both be created, alternatively, with either tabs 40, 42 individually or together. Accordingly, both tabs 40, 42 are a means for locking and a means for stopping.
With respect to assembly, blank 10 is folded and connected, using conventional techniques, to create the combined internal slide card and inner tray 12, best shown in
After assembly, the inner tray 12 is configured to receive and store an injectable device (not shown). In the illustrated embodiment of
Similarly, here apertures 36, 38 are shaped as an “X” and as an oval because these shapes can hold a bare needle, capped needle, or the neck of a vial in a particular position while allowing easy access. Those skilled in the art will understand that apertures 36, 38, as a means for securing an injectable, may be configured in various shapes depending on the injectable and ease or complexity of access desired. For example, an injectable comprising a plunger handle, barrel, and needle may be stored by placing the plunger handle in receiving slot 34 and the needle in the aperture 36, 38 located in the opposite inside sidewall panel 30, with the barrel spanning the space in between. In this manner the plunger of a pre-filled injectable is protected from inadvertent pressure, and the user is protected from inadvertent contact with the needle.
Here the inner tray 110 is also configured to allow for easy access to the injectables. By way of illustration and not limitation the injectables are arranged alternately so that the end user, who may have limited physical mobility such as that resulting from arthritis, can retrieve one injectable without affecting another. As illustrated, purposefully orientating the widest portion of the injectable, in this example the finger guard 120, to take the most space to provide the greatest accessibility is a desirable feature of this embodiment. Such horizontal orientating also provides easy viewing of the products so the user may easily distinguish between them. Further, such orientating provides ample area to receive graphics. Patient and healthcare provider information, such as dose compliance, can be made easily visible to the user.
The embodiment of
Turning now to
With regard to assembly, the blank 202 is folded and connected, using conventional techniques, to create the outer sleeve 200, best shown in
Tabs 226 are folded inwardly to create a closed end wall, such that the backs of tabs 226 are orientated toward the interior case created by the side panels 204, 206 and spine panels 210. End panels 216, 218 are then folded inwardly so that the face of tabs 226 may be affixed to the back of panel 216 and the face of panel 216 may be affixed to the back of panel 218, to complete the closed end wall.
In addition, extension panels 220 are folded inwardly so that the back of panels 220 may be affixed to the backs of respectively adjacent side panels 206, 208. Similarly, extension tabs 228 are folded inwardly so that the backs of tab 228 may be affixed to the respectively adjacent spine panels 210. The folding of panels 220 converts the cutouts 230 into finger-access areas.
Generally speaking, injectables are placed within inner tray 12, 100 and then the inner tray 12, 100 is inserted into outer sleeve 200. The apparatus holds and protects the injectables until they are retrieved for use. In practice, and with reference to
With the internal card and inner tray 12 loaded with injectables and folded as described immediately above, the tray 12 is inserted, starting with the edge comprising the tabs 40, 42 and with tab 40 receivingly aligned with the catch formed by cutout 222 and release button 224, into the void of outer sleeve 200. The internal card and inner tray 12 is fully inserted into the outer sleeve 200, to a fully closed position. As understood by those skilled in the art, the spring tension created by the outwardly folded tabs 40, 42 causes the leading edge of the tabs 40, 42 to press against the interior side of the panels 204, 208, 210. The position of the tab 40 provides a locking feature and the tab(s) 42 provide a stopping feature. For purposes of teaching and not limitation, the locking feature is described with regard to tab 40, and the stopping feature is described with regard to tab 42. It will be understood that either tabs 40 or 42 could interchangeably perform either the locking or stopping features.
In this illustration the locking feature includes the catch formed by the cutout 222, the release button 224 and cooperatively interlocking tab 40. The spring tension created by the compressed tab 40 causes the leading edge of tab 40 to engage the internal edge 240 of the panel 208. With the tab 40 and leading edge 240 engaged, the inner tray 12 is locked and cannot be opened. This means for locking creates a child-resistant feature. To unlock the child-resistant feature of this embodiment and thereby open the tray 12, the user depresses the release button 224, created by the cut 23, which in turn depresses the tab 40 to disengage the leading edge of the tab 40 from the internal edge 240. It will be understood that another means for locking may be created by placing one or more release buttons in panel(s) 210 to releaseably engage tab(s) 42.
After releasing the optional locking feature, the inner card 12 may be pulled out, until the stopping tabs 42 engage the extension tabs 228, to a fully open position. As will be understood by those skilled in the art, the spring tension created by the compressed tabs 42 causes the leading edge of the tabs 42 to engage the tabs 228. Once engaged, the tray 12 cannot be further removed from the outer sleeve 200 but may be reinserted to a fully closed position if desired. In this manner, tabs 42, 228 act as a stopping device to prevent inner card 12 from being pulled completely out of outer sleeve 100. It will be understood that another means for stopping can be created by allowing tab 40 to engage extension tabs 220.
The user may open and close the apparatus by withdrawing and replacing the inner tray 12 within the outer sleeve 200 as often as desired. In the fully open position, the user may fold back the top panel 20 to access an injectable. After accessing the desired injectable, the user replaces the top panel 20 and reinserts the inner tray 12 within the outer sleeve 200 for future use.
Alternatively, an embodiment designed to be disposed of, together with used injectables, may be placed within a red plastic bag (not shown but provided with the embodiment) thereby giving notice of the contents. By way of illustration and not limitation, additional means for protecting and sealing an embodiment to be disposed of, together with used injectables, include sealable bags, a self-sealing outer sleeve, a sealable outer sleeve large enough to receive the inner tray 12 and outer sleeve 200. Similarly, taping the inner tray 12 within the outer sleeve 200 with red tape giving notice of the contents is a means for protecting and sealing.
With regard to the materials of construction, the illustrated embodiments comprise paperboard as a substrate for blanks 10, 202, which is typically constructed from a sheet of bleached sulphate, solid unbleached sulphate, or clay-coated paperboard. Compositionally, the paperboard coating is a fluidized blend of materials, such as coating clay, calcium carbonate, and/or titanium dioxide, with starch or adhesive that is smoothly applied to the traveling surface. Successive densification and polishing finish the mineral-coated surface to a superior, graphic-print surface. Other embodiments may comprise vacuum-formed plastic or paper, press-formed paperboard, cardboard, or combinations thereof.
It must be emphasized that the law does not require and it is economically prohibitive to illustrate and teach every possible embodiment of the present claims. Hence, the above-described embodiments are merely exemplary illustrations of implementations set forth for a clear understanding of the principles of the invention. Variations, modifications, and combinations may be made to the above-described embodiments without departing from the scope of the claims. All such variations, modifications, and combinations are included herein by the scope of this disclosure and the following claims.
This application claims priority to co-pending U.S. Provisional Application No. 60/591,677, filed on Jul. 28, 2004, which is entirely incorporated herein by reference. The application also claims the benefit of the filing date of co-pending International Patent Application No. PCT/US05/26779 (now US Non-Provisional application Ser. No. 11/572,673), filed Jul. 28, 2005, which is also entirely incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 60591677 | Jul 2004 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 11572673 | Oct 2007 | US |
| Child | 12710201 | US |
