Abstract:
A package and method of packaging dangerous goods for transport, and in particular infectious substances, is disclosed. The package includes an outer collapsible container, an inner collapsible container, and means for suspending the inner collapsible container within the outer collapsible container. In a preferred embodiment, the outer collapsible container may be made of fiberboard and dimensioned for receipt and retention of the inner collapsible container, which may also be made of fiberboard. The inner container receives and maintains primary receptacles containing an infectious substance. If desired, the inner container may also receive and maintain a secondary container that receives the primary receptacles. The suspension means may comprise flap panels formed integrally with the outer container.

Description:
TECHNICAL FIELD 
     The present invention relates to the safe and efficient transportation of dangerous goods. More particularly, the present invention relates to an improved package and method of packaging dangerous goods, such as infectious substances for transport so as to protect users, handlers and the general public from exposure to such substances. 
     BACKGROUND 
     The handling and transport of dangerous goods is an increasingly complex and difficult task. The definition of a dangerous good may depend on the regulatory body consulted. Generally speaking, regulations tend to classify goods as dangerous based, primarily, on their respective inherently hazardous properties. For example, the Canadian Transportation of Dangerous Goods Regulations define “dangerous goods” as any product, substance or organism in any of nine classes of materials: explosive; gases; flammable and combustible liquids; flammable solids; oxidizing substances (such as organic peroxides); poisonous, toxic and infectious substances; radioactive materials; corrosives; and various and miscellaneous products, substances or organisms considered to be dangerous to life, health, property or the environment when transported. These regulations apply to the handling, shipping, transporting and importing of any such goods throughout Canada by any means of transportation. 
     Canada is not the only country or regulatory entity to be concerned with the transport of dangerous goods. The United States Hazardous Materials Regulations provided in 49 C.F.R. address the transportation of dangerous goods within the United States. The International Maritime Organization has issued the International Maritime Dangerous Goods Code, which is used in both Canada and the United States for international shipments by the marine mode. The International Civil Aviation Organization (ICAO”) has issued regulations that, together with operator requirements, are included in the International Air Transport Association (“IATA”) Dangerous Goods Regulations. Once again, both the United States and Canada use these regulations to govern the shipment of dangerous goods by air, both domestically and internationally. Yet further, the United Nations Committee of Experts has issued the United Nations Recommendations on the Transport of Dangerous Goods. 
     Enforcement of dangerous goods regulations has been an evolutionary process. Many of these regulations were not adopted until the 1980&#39;s. Even though IATA has regulated the international transport of dangerous goods since the 1970&#39;s, many businesses and shippers were not even aware of such regulations. As a result, the demand for dangerous goods packaging and packaging methods has increased as shippers and others have become increasingly aware of the regulations. Failure to comply with such regulations can, of course, be catastrophic. For example, in December of 1999, American Airlines&#39; parent company, AMR, pled guilty to a felony charge and paid an $8 million fine for mishandling barrels filled with the chemical Dioxital. In 1996, an aircraft maintenance company failed to properly package oxygen canisters blamed for a cargo hold fire in a Valujet aircraft, causing the jet to crash in the Florida Everglades. Such high profile instances of failure to comply with such regulations have also greatly increased awareness. 
     Perhaps for similar reasons, the advent of infectious substance packaging and associated packaging methods has also been an evolutionary process. An early patent in this area is U.S. Pat. No. 4,882,893, entitled “Container for the Transport of Diagnostic Specimens.” This patent discloses a method of packaging vials containing infectious substances or diagnostic specimens for purposes of transport. This method can be practiced by use of a package presently offered and sold by Saf-T-Pak, Inc. of Edmonton, Alberta, Canada under the designation “STP-100”. This package includes a pressure vessel, or “secondary” container for receipt of vials containing an infectious substance,” and a fiberboard outer container. This packaging relied upon cardboard (fiberboard) material to provide resistance to impact from dropping or puncture. This was the first package to be approved for use by a government regulatory entity, namely—Transport Canada. 
     A subsequent patent, U.S. Pat. No. 5,160,021, issued Nov. 3, 1992, and is entitled “Leak-proof Cylindrical Container for the Transport of Diagnostic Specimens or Dangerous Substances.” This patent disclosed a leak-proof secondary container for packaging vials containing diagnostic specimens and the like. The disclosed container provided an open-topped cylinder having a radial groove adjacent its top end for retaining an o-ring gasket. A cap for the cylinder was also disclosed. The cap included a circular top wall and a skirt sized to slide over the top of the cylinder to sealingly engage an o-ring gasket. 
     As stated in both of these patents, the threat of user or handler infection due to inadvertent contact with blood that has been infected with the AIDS (Acquired Immune Deficiency Syndrome) virus (or some infectious substance) has also heightened awareness of the need for proper packages and methods of packaging such substances for transport. Using the shipment of blood as an example, the vial or “primary container” would be filled by a user (typically a technician or lab clerk) and inserted into a secondary container. Once that secondary container was properly sealed, an outer package is provided. The regulations typically require a water-tight primary container (a vial), a water-tight secondary packaging (a proper secondary container), absorbent material between the primary and secondary containers, and an outer container of sufficient strength to meet certain performance tests. The regulations do not provide or require a certain structure, such as, for example, a certain outer packaging. Instead, the regulations require that the package and/or method as a whole meet certain requirements. For example, the U.N. Recommendations require that the package pass a drop test of the entire package from nine (9) meters, a penetration test using a steel cylinder weighing 7 kilograms dropped from a point one (1) meter above the package, and a pressure test. These two patents therefore show two ways to address and comply with the regulations and/or recommendations. There are, of course, many more. 
     Such prior art packages have proven effective for transporting infectious substances and other dangerous goods. However, the weight and rigid construction of such prior art packaging components is a problem for shippers and users. Such packages are difficult to ship because they cannot be collapsed or “knocked-down” prior to use. The package therefore requires a significant space for both storage and shipment. Many prior art packages rely on cardboard (fiberboard) packing material to such cushion the secondary container. Such materials may be attached to or separate of the outer packaging, but nonetheless require additional space. Should the plastic secondary container become damaged, it must be repaired or replaced. Thus, there is a continuing need in the art for an improved package and to improve known methods of packaging infectious substances and other dangerous goods. 
     SUMMARY OF THE INVENTION 
     The present invention fills the above-described need in the prior art by providing an improved package and method of packaging infectious substances that includes collapsible packaging elements and avoids the use of additional packing material to meet the requisite performance tests. The present invention is also lighter than prior art packages and therefore more economical in use. 
     Generally described, the present invention comprises a first collapsible container, a second collapsible container, and means for suspending the second container within the first container. 
     Described somewhat more particularly, the present invention comprises an outer package including at least two surfaces, an inner package dimensioned to be received by the outer package, and means associated with the two surfaces of the outer package for suspending the inner box within the outer box. In a preferred embodiment, the means for suspension may comprise at least one scored flap panel integrally formed with one or more of the two surfaces of the outer package that, when properly manipulated, captures and suspends the inner package in such a way as to suspend the inner package within the outer package. 
     The present invention further includes a method of packaging an infectious substance or dangerous good. Generally described, a preferred method comprises causing the substance to be shipped to be confined within a first container, placing the first container within a second container, placing the second container within an inner package, and suspending the inner package within an outer package for shipment. 
     Thus, it is an object of the present invention to provide an improved package and method of packaging dangerous goods for transport that may be certified by a regulatory authority and thus passes the performance tests established by that regulatory authority. 
     It is a further object of the present invention to provide an improved package and method of packaging dangerous goods for transport that may be certified by a regulatory authority and thus passes the performance tests established by that regulatory authority. 
     It is a further object of the present invention to provide an improved package and method of packaging dangerous goods for transport that is capable of reducing the weight of shipment and shipping components. 
     It is a further object of the present invention to provide an improved package and method of packaging dangerous goods for transport that is economical and efficient to make, ship and use. 
     It is a further object of the present invention to provide an improved package and method of packaging dangerous goods that is particularly well suited for the transport of infectious substances. 
     It is a still further object of the present invention to provide an improved package and method of packaging dangerous goods that is particularly well suited for infectious substances and avoids the use of additional packaging material where possible. 
    
    
     These and other objects and advantages of the present invention will become apparent upon reading the following detailed description of preferred embodiments in conjunction with the drawings. 
    
    
     DETAILED DESCRIPTION 
     Referring now in more detail to the drawing, in which like numerals represent like parts throughout the several views, FIG. 1 shows an improved package  10  according to the present invention As illustrated, the package  10  provides an outer box  11  and an inner box  100 . The inner box  100  is configured for and suspension within the outer box  11 . FIG. 1 is a perspective view that shows both the outer box  11  and the inner box  100 , as explained in greater detail below. 
     The outer box  11  defines six sides  12 ,  14 ,  16 ,  18 ,  20  and  22 . Side  12  defines the top of the package  10 . Sides  14 ,  16 ,  18  and  20  define the sides of the package  10 . Side  22  defines the bottom of the package  10 . It is to be noted that, in this embodiment of the invention, the top side  12  and the bottom side  22  each define two panels  12   a ,  12   b ,  22   a  and  22   b , respectively. The utility of this construction will become apparent by reading the following. 
     The outer package  11  is preferably made of fiberboard, sometimes colloquially referred to as cardboard, or any other suitable material. While fiberboard is a preferred material, the outer package  11  may also be made of plastic, wood, fiberglass, steel or any other material suitable for the purposes set forth herein. 
     FIG. 2 shows a top plan view of a preferred blank  11 ′ for production of the outer package  11 . The blank  11 ′ has four main panels  25 ,  26 ,  27  and  28  and a tab extension  29  foldably connected along score lines  30 ,  31 ,  32  and  33 . The blank  11 ′ further includes four top panels  35 ,  36  ,  37  and  38  foldably connected to the main panels  25 ,  26 ,  27  and  28  along score lines  40 ,  41 ,  42  and  43 , respectively. The blank  11 ′ further includes four bottom panels  45 ,  46 ,  47  and  48  foldably connected to the main panels  25 ,  26 ,  27  and  28  along score lines  50 ,  51 ,  52  and  53 . It is to be appreciated that when the outer package  11  is formed, the main panels  25 ,  26 ,  27  and  28  form the outer walls  14 ,  16 ,  18  and  20  of the outer package  11  shown in FIG. 1; the top panels  35  and  37  form the top walls  12   a  and  12   b  of the outer package  11  shown in FIG. 1; and the bottom panels  45  and  47  form the bottom walls  22   a  and  22   b  of the outer package  11  shown in FIG.  1 . 
     Referring in greater detail to FIG. 2, it is shown that top panels  35 ,  36 ,  37  and  38  provide score lines  55 ,  56 ,  57  and  58 , respectively. In like fashion, the bottom panels  45 ,  46 ,  47  and  48  provide score lines  65 ,  66 ,  67  and  68 , respectively. Further, the edge portions of the top panels  35 - 38  and  45 - 48  are specially configured. More particularly, top panels  35 ,  36 ,  37  and  38  define respective flap edges  75 ,  76 ,  77  and  78  and bottom panels  45 ,  46 ,  47  and  48  define respective flap edges  85 ,  86 ,  87  and  88 . It is to be noted that the edges  75 ,  77 , and  85 ,  87  of flaps  35 ,  37  and  45 ,  47  respectively are mirror images one of the other. Similarly, top panels  76 ,  78  and  86 ,  88  of flaps  36 ,  38  and  46 ,  48 , respectively, are also mirror images of one another. 
     Referring in greater detail to top panels  75 ,  77  and bottom panels  45 ,  47 , it is seen that their respective edge portions each define cut-out sections  90  and two indented areas  91 , the purpose of which will become apparent. Referring in greater detail to top panels  36 ,  38  and bottom panels  46 ,  48 , it is seen that each include a rectangular cutout portion  93  and a cut-out section  95  at their respective edges  76 ,  78 ,  86  and  88 . 
     It is to be understood that the outer box  11  is formed by connecting or gluing tab  29  to the edge portion (shown in phantom at  99 ). It is to be further understood that, once this operation is performed, main panels  25  opposes main panel  27 , and main panel  26  opposes main panel. As shown below, when the panels  35 ,  45  and  37 ,  47  are brought together in a back to back fashion, the end portions thereof (designated  35   e ,  45   e  and  37   e ,  47   e ) mating panels  36 ,  46  and  38 ,  48  act to form a suspension mechanism that captures and retains the internal package  100 . 
     FIG. 3 shows a blank  101  that includes four main panels  105 ,  106 ,  107  and  108  foldably connected along score lines  110 ,  111  and  112 . A tab extension  113  is foldably connected to main panel  105  along a score line  114 . The blank  101  further includes four top panels  115 ,  116 ,  117  and  118  foldably connected to respective main panels  105 ,  106 ,  107  and  108  along respective score lines  120 ,  121 ,  122  and  123 . Similarly, the blank  101  includes four bottom panels  125 ,  126 ,  127  and  128  foldably connected to respective main panels  105 ,  106 ,  107  and  108  along respective score lines  130 ,  131 ,  132  and  133 . Those of ordinary skill in the art will appreciate that this blank  101  may readily be formed into an inner box as shown in FIG.  4 . It is also to be understood that the inner box is to be of sufficient dimension to accept primary receptacles that are conventionally used to ship diagnostic specimens, hazardous goods and the like. 
     Use of the present invention defines a novel and improved method for shipment of diagnostic specimens, specifically, for infectious substances. As shown in FIG. 5, a primary receptacle or vial  205  is filled with blood or some other infectious substance. In accordance with accepted practice as required by regulation and suggested by recommendation, the vial or primary receptacle is substantially leakproof. Accordingly, the primary receptacles  205  may be a plastic screw cap vial (such as that presently offered by Corning Cryogenic or Fisher centrifuge tubes), a glass screw top container, a vacutainer, a blood bag (such as that presently offered by Medsep Corp.) or a petri dish. Of course, any other acceptable or suitable primary receptacle may be used. 
     The primary containers are then preferable wrapped, covered withn or placed in a shock resistant or shock absorbent material. A single primary receptacle may be so wrapper, covered or placed, or a plurality of primary receptacles may be wrapped, covered or placed together. Such a procedure is recommended, but may not be required by a particular recommendation. One may practice the present invention with or without wrapping, covering or placing the primary vial into any such material. The primary receptacle or receptacles are then placed into a secondary container  200 , along with sufficient absorbent material  210  to absorb the entire volume of an infectious substance in the primary receptacles  205 . Such an operation is conventionally required by regulation or suggested by a recommendation. The secondary container is preferably a pressure vessel that is capable of withstanding 95 kps for a sufficient time to demonstrate the appropriate or desired safety level. An appropriate time may range from a few seconds to as long as thirty (30) minutes depending on the specific recommendation or regulation being followed. A well suited secondary container is that shown and described in U.S. Pat. No. 4,882,893. Such a container (and others) is well-known to those of ordinary skill in the art and need not be disclosed further herein. 
     The secondary container is then placed within the inner box  100 , and the top and, if necessary, bottom flaps  115 - 118  and  125 - 128  are closed in a usual manner. It is to be understood that the present invention may be practiced regardless of whether the inner box  100  is partially formed, or not formed at all, prior to placement of the secondary container into the inner box  100 . It is only necessary that the secondary container  200  be inserted or otherwise placed into the inner box  100  and the box secured within the secondary container for shipment. Those of ordinary skill will appreciate that while the flaps  115 - 118  and  125 - 128  may be glued one to the other to insure the integrity of the inner box  100 . However, due to the construction of the present invention, it is to be understood that the suspension means or flaps  35 - 38  and  45 - 48  will maintain the inner box  100  in a suitable position for shipment. 
     The inner box is then inserted or otherwise placed into the outer box  11 . The outer box, relying primarily on the extensions  35   e - 38   e  and  45   e - 48   e  provides a mechanism for suspending the inner box  100  therein. It is of no relevance to the inventive concept whether the inner box  100  is placed within a partially formed outer box with or without a secondary container. It is only relevant that the secondary container is placed within the inner box  100 , the inner box is secured contains the secondary container  200 , and the inner box is then suspended within the outer box  11  for shipment. 
     Use of the preferred embodiment of the invention may include forming the outer package  11 . To do so, the tab extension  29  is secured at position  99  on main panel  28 . Of course, this operation may be performed by the manufacturer, as opposed to the user, since the package  11  may be “Knocked-down” once the tab extension  29  is glued or otherwise attached at position  99 . 
     The package  11  may then be constructed by preferably forming the bottom of the package first. To do so, bottom flaps  46  and  48  are folded inward about score lines  51  and  53 , respectively. Then, bottom flaps  45  and  47  are folded inwardly so that panels  45   a  and  47   e  are placed in a back-to-back fashion projecting upwardly in a substantially vertical plane, as shown in FIG.  1 . Then, the flaps  46   e  and  48   e  are folded into a substantially horizontal plane about score lines  66  and  68 , respectively. It will be appreciated that this operation is facilitated, in part, by the slots  93 . In so doing, the flaps  45 - 48  create a suspension mechanism such that the projecting end of flaps  46  and  48  extend partially along the side of the inner box  100 . Ends  86  and end  88  run along the entire length of opposing sides of the inner box  100 . The ends  85  and  87  extend upwardly to engage the bottom of the inner box  100 . Thus, it is to be understood that edges  85 ,  86 ,  87  and  88  contact and retain the inner box  100 . 
     In like fashion, the top flaps  36  and  38  are first folded inwardly, then the other top flaps  35  and  37  are folded inwardly about score lines  40  and  42 , respectively, to form a mirror image arrangement to that described above. It will be appreciated that folding flaps  35  and  37  inwardly forms the top surfaces  12   a  and  12   b  as shown in FIG.  1 . Ends  75  and  77  of flaps  35  and  37  engage the top of inner box  100 , and the projecting portions of said flap extend partially around the inner box. Thus, it is to be understood that ends  75 ,  76 ,  77  and  78  contact and retain the inner box  100 . 
     Accordingly, the panels  35 - 38  and  45 - 48  comprise a device that suspends the inner box  100  within the outer box or package  11 . 
     A package made in accordance with the foregoing preferred embodiments has been tested in accordance with Part 6, Chapter 6.3 of the United Nations Recommendations and the CGSB Standard 43.125-M99 Type 1A-High Integrity Packaging for Infectious Substances and the United States Regulations contained in 49 C.F.R. 178.6. Accordingly, a package made in accordance with the foregoing preferred embodiments has been subjected to a leak test, drop test, impact test, stacking test and vibration test. This package has received a “pass” designation for each such test. 
     Alternative embodiments of the present invention may call for the substitution of various materials. For example, the inner box  100  may be made of a material of different composition than that of the outer box  11 . In a preferred embodiment both the inner box  100  and the outer box  11  are made of single-wall corrugated fiberboard. Nonetheless, the person of ordinary skill in the art will appreciate that any other suitable material or materials may be used. 
     The principles, preferred embodiments and modes of operation of the present invention have been described in detail, including the best mode thereof, in the foregoing specification. The invention is not to be construed as limited to the particular forms disclosed, because these are regarded as illustrative and not restrictive. Accordingly, variations and changes may be made by those skilled in the art without departing from the spirit or scope of the invention as set forth in the following claims.