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'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. Patent No. 5,150, 971, which is incorporated herein by this reference. Other shipping devices are disclosed in U. S. Patent 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, June 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: (1) an outer layer; (2) a metallic, water-resistant, substantially non-light transmissive middle layer ; (3) a first polymeric layer having a printable surface facing away from the outer layer; and (3) 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 101a and a back panel 101b 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 101a 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 101a and the continuation of the back panel 101b, 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 101b from the insertion region 115 to the termination of the back panel 101b, 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 101a. 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 101a 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 101a 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 101a 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. Patent 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. 01 cm (4 mils) to about. 015 cm (6 mils) thick; the middle layer 320 is typically about. 007 cm (0.27 mils) to about. 008 cm (0.33 mils) thick; and the third layer 330 is typically about. 0025 cm (1 mil) to about. 025 cm (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 101a or 101b, 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.

Patent 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 of 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. 001 cm (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. 004 cm (1.5 mils) and the other layer has a thickness of about. 001 cm (0.5 mils). The foil is aluminum foil having a thickness of about. 008 cm (0003 inch). The paper is bleached Kraft paper and has a basis weight of about 34 kg (76 pounds) per ream, and a thickness of about. 013 cm (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.