Patent Publication Number: US-2005116014-A1

Title: Shipping device suitable for biohazardous specimens

Description:
BACKGROUND  
      Specimen envelopes are commonly used for patient-friendly specimen collection devices. These collection devices allow patients to obtain certain etiologic agents and/or biomedical materials in the privacy of the patient&#39;s home, and send the obtained materials for testing through the mail. For example, fecal specimens are delivered this way using Beckman Coulter Hemoccult® products. Shipping devices for specimens are well known in the art. For example, see U.S. Pat. No. 5,150,971, which is incorporated herein by this reference. Other shipping devices are disclosed in U.S. Pat. Nos. 5,918,983 and 5,921,396.  
      Recently the United States Postal Service has revised mailing standards relating to sending biohazardous materials in the mail. See, for example, Federal Register, Volume 68, No. 109, pages 33858-33873, Jun. 6, 2003. One of the requirements for sending biohazardous substances is that a biohazard symbol be visible if the envelope is torn or inadvertently opened, exposing individuals to its contents.  
      Thus, there is a need for a shipping device which can safely be used for mailing biohazardous materials, and that satisfies the safety regulations of the U.S. Postal Service.  
     SUMMARY  
      The present invention is directed to shipping devices that satisfies this need. In one version of the invention, such a device, which is typically in the form of an envelope, comprises a printed outer layer and a polymeric, water resistant inner layer having a printable surface facing the outer layer, wherein the two layers are joined together such as by lamination. There are printed indicia on the printable surface, with the result that the inner layer serves to protect the printed indicia from the contents of the mailing device.  
      Typically the laminate also includes a metallic, water-resistant, substantially non-light transmissive middle layer. Preferably, the printed indicia comprises biohazard indicia on a field of substantially solid printing.  
      The device can be formed by printing indicia on the printable surface of the inner layer, joining the outer and inner layers together such as by lamination, while including the optional middle layer at the same time.  
      In another version of the invention, there is a polymeric layer between the outer and middle layers to better effect lamination.  
      Another version of the invention is an envelope type device having a wall structure that comprises from outside to inside: 
          a. an outer layer;     b. a metallic, water-resistant, substantially non-light transmissive middle layer     c. a first polymeric layer having a printable surface facing away from the outer layer; and     d. a second polymeric layer protecting the printable surface, the second layer being substantially transparent, 
 
 wherein at least one of the first and second polymeric layers is substantially water proof, and wherein there is a printed biohazard warning on the printable surface of the first polymeric layer.
       

    
    
     DRAWINGS  
      These and other features, aspects, and advantages of the present invention will become better understood with reference to the following description, appended claims, and accompanying drawings where:  
       FIG. 1  is a perspective view of an embodiment of a shipping device according to the present invention, in an open position;  
       FIG. 2  is another perspective view of the device of  FIG. 1  partially cut away to show internal printing where the device is in a sealed configuration;  
       FIG. 3  is a sectional view of a laminate suitable for forming the device of  FIG. 1 ; and  
       FIGS. 4 and 5  are sectional views of alternative laminates suitable for forming the device of  FIG. 1 .  
    
    
     DESCRIPTION  
      With reference to  FIGS. 1 and 2 , a specimen shipping device  100  having features of the present invention is depicted. Only some of the features shown in the drawings are required according to the present invention. Thus, the invention herein is not limited to the versions shown in the figures. The device  100  comprises a front panel  101   a  and a back panel  101   b  folded along a bottom crease  103  with opposed sides  105  and  107  securely sealed together by any suitable sealing method, such as by an adhesive, glue, or heat sealing. The first panel  101   a  has mailing information printed thereon. The device  100  is preferably formed of a single sheet because sealing along the bottom crease  103  is not required; however, two separate sheets can be utilized, whereby a side corresponding to the crease  103  is sealed in a manner analogous to that used in the sealing of the sides  105  and  107 .  
      Referring now to the region of the device  100  opposite to the crease  103 , a test device insertion region  115  is defined by the termination of the front panel  101   a  and the continuation of the back panel  101   b , whereby a pocket or pouch region is formed, generally being defined as the entire interior region between the sides  105  and  107 , the crease  103 , and the insertion region  115 . A flap  116  is defined by the extension of the back panel  101   b  from the insertion region  115  to the termination of the back panel  101   b , and can include means for indicating the closing off and sealing of insertion region  115 . As an example of a means for indicating, a crease  120 , located about one-fourth of the distance of the flap  116  upwards from the insertion region  115 , defines the area of the flap  116  that is folded to secure an etiologic agent and/or biomedical material (not shown) which has been inserted into the pouch region of the mailing device  100 . Alternative means for indicating the closing off of the sealing insertion region  115  include, for example, instructions informing the user to fold the flap  116  at a point above the insertion region  115 , or hash-mark indicators located at about one-fourth to about one-half of the distance upwards from the insertion region  115 .  
       FIG. 2  shows the device  100  having the flap  116  folded along the crease  120  and in secure contact with an upper region of the side  101   a . By folding the flap  116  along the crease region  120 , the specimen device insertion region  115  (shown from a cut-away of flap  116 ) is advantageously located below the crease  120  and above a reference line  121  (shown in phantom) where the flap  116  and the front panel  110   a  are approximately joined. This folding configuration negates the risk of leakage out from or into the region  115  in that the region  115  is covered and sealed. Such sealing is preferably effectuated by incorporation of an adhesive  130  on the flap  116  and a region  131  between the termination of the front panel  101   a  and the crease region  120 . Thus, when the flap  116  is closed, the adhesive  130  secures the flap  116  to both region  131  and from the reference line  121  up to the insertion region  115 . The adhesive can be protected prior to use by removable protective tape (not shown). As an alternative to the use of an adhesive, sealing materials, such as, for example, an adhesive tape, can be applied to the flap  116  when it is in its closed position so that sealing thereof to the front panel  110   a  is similarly effected.  
      The device  100  can optionally include tabs extending outwardly from flap  116  in a direction perpendicular to flap  116  as described in U.S. Pat. No. 5,150,971 for additional sealing effectiveness.  
      Preferably the device  100  is formed by die cutting a single sheet  301  with the flap  116  and the crease  120  are formed during the die-cutting process.  
      A single sheet  301  suitable to form the device  100  is shown in  FIG. 3 . Thus  FIG. 3  shows the wall structure of the device  100 . The single sheet  301  comprises three layers: a first layer  310  (i.e. the outer layer) that can be paper or cardboard; an optional second layer  320  (i.e. the middle layer) that can be a metallic foil or metallized polymeric material; and a third layer  330  (i.e. the interior or inner layer) that can be a thin layer of polymeric material that is water resistant and flexible, such as polyethylene or polypropylene, laminated thereon to seal the second layer  320  to the first layer  310 . Three layers are preferred because the middle layer  320 , which is sealed to the outer layer  310  by the interior layer  330 , acts as a primary barrier against leakage of the etiological and/or biomedical materials through the outer layer if such material begins to leak from the pouch region. In addition the middle layer  320  prevents light from degrading a specimen in the envelope and prevents leakage of malodorous gas from the envelope. Accordingly, metallic foils (such as aluminum) and metallized polymeric materials are most preferred for the middle layer because such materials prevent such leakage.  
      Paper or cardboard materials are most preferred for the outer layer  310  in that these can be readily pre-printed with information typically imprinted on mailing envelopes (i.e. postage stamp location, return address information, as well as any pertinent instructions).  
      Polyethylene and polypropylene are most preferred for the third layer  330  in that these materials are useful in a heat-sealing lamination process because these materials, by their very nature, form a sealed bond upon heating and can be printed thereon.  
      The first layer  310  is typically about 4 to about 6 mils thick; the middle layer  320  is typically about 0.27 to about 0.33 mils thick; and the third layer  330  is typically about 1 to about 10 mils thick.  
      A layer of adhesive  130 , as previously detailed, is preferably added onto the third layer  330  and can begin directly above the insertion region  115 , covering the flap  116 , and region  131 . When completed, the mailing device can have mailing information printed on sides  101   a  or  101   b , as well as any other pertinent and/or additional information.  
      At least a portion of the surface  331  of the third layer  330  that faces the first outer layer  310  has printing thereon, such as a biohazard warning. This can be effected by corona treating the surface  331 , and printing with a flood coating  332  of orange or red, and then printing with a plurality of spaced apart black biohazard warnings  333 . The ink used can be a conventional solvent based ink printed using a lithographic or flexographic technique. The printing is performed before laminating the layers together. Because the printing is on the protected surface  331  of the third layer  330 , it is protected from the contents of the envelope  100 . Thus samples such a liquids, i.e. blood, or semi-solids, such as fecal specimens, do not adversely affect the printing. The third layer is substantially light transmissive, and preferably substantially transparent so that the printing  332  and  335  is visible.  
      The laminate can contain additional layers. For example, with reference to  FIG. 4 , there is shown a laminate  301 ′ with an additional polymeric layer  340  between the outer layer  310  and the middle layer  320 . This layer  310  can be about 0.5 mils thick. Also an additional layer or barrier (not shown) can be layered on top of the third layer  330  to form a pocket within the envelope to act as additional security against any potential leakage from an etiologic agent and/or biomedical material inserted into the device, as described in U.S. Pat. No. 5,150,971.  
      Also, the biohazard printing need not be on the surface  331  of the third layer  330  facing the first layer  310 . Rather, as shown in  FIG. 5 , the printed warning of a laminate  301 ″ can be on the opposed surface  332  of the laminate, wherein the printing is protected by a protective layer  350  which is substantially light-transmissive, and preferably substantially transparent. In this version fo the invention, this protective layer  350  need not encompass the entire inside of the device  100  but rather only needs to be over the printing. The protective layer can be about 0.5 mils thick. In this version of the invention, it is not necessary that the third layer  330  be light transmissive.  
     EXAMPLE  
      An envelope device is made from a four layer laminate comprising, from the outside to the inside, paper/polyethylene/aluminum foil/polyethylene. Both polyethylene layers are low density polyethylene, where the printed layer has a thickness of about 1.5 mils and the other layer has a thickness fo about 0.5 mils. The foil is aluminum foil having a thickness of about 0.0003 inch. The paper is bleached Kraft paper and has a basis weight of 76 pounds per ream, and a thickness of 5.4 mils. The outer surface  330  of the paper is printed as shown in  FIG. 1 . The outwardly facing surface  331  of the inner layer  330  of polyethylene is printed as shown in  FIG. 3 . The printing is effected with a flood coating process using red colored type ink for the background, with the black biohazard being printed with black ink. Preferably substantially the entire surface  331  is printed so that no matter where the envelope  100  is opened, the printed indicia is visible.  
      To use the device  100 , a specimen collection device including an etiologic agent and/or biomedical material is inserted into the interior portion of shipping device  100  at insertion region  115 . A protective tape (not shown) covering adhesive  130  is removed, and the flap  116  is folded along the crease  120  such that the flap  116  securely seals the insertion region  115 . Mailing of the device is then accomplished in a manner as defined by the rules and requirements for utilization of the applicable postal service. When received by a healthcare professional, the test device can be removed by cutting or tearing open the mailing device along any edge. If the device is inadvertently opened, the printed biohazard warning becomes visible.  
      All features disclosed in the specification, including the claims, abstracts, and drawings, and all the steps in any method or process disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. Each feature disclosed in the specification, including the claims, abstract, and drawings, can be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.  
      Any element in a claim that does not explicitly state “means” for performing a specified function or “step” for performing a specified function, should not be interpreted as a “means” or “step” clause as specified in 35 U.S.C. § 112.  
      Although the present invention has been described in considerable detail with reference to the preferred versions thereof, other versions are possible.  
      For example, the printing can be on a surface of a fourth additional layer that faces the first layer  310 . What is important to the present invention is that the innermost layer be substantially light transmissive or transparent, and that it protect the printing from the contents of the device. If there is such a fourth layer, it is not necessary that the third layer be substantially transparent.  
      Also, lamination need not be used to the join the layers of sheet  301  together. For example, adhesive can be used.  
      Therefore the scope of the appended claims should not be limited to the description of the preferred versions contained therein.