Containment device for biological materials

A containment device for sealing and protecting containers of biological materials. The device comprises a resilient cushion of aqueous fluid sorbent material having a plurality of openings. Each opening is adapted for receiving a respective container of biological material, and the openings are arranged such that each opening is surrounded by sufficient sorbent material to sorb leakage of biological material from its respective container if the container and/or if any additional containers break. The device also includes a case of aqueous fluid resistant material for receiving and enveloping the fluid sorbent material. The case includes two generally stiff-flexible portions having parts adapted for complementary interengagement and adapted to receive means for sealing the portions together to form an air and fluid tight package.

FIELD OF THE INVENTION 
This invention relates generally to containers, and more particularly to a 
containment device for shipping or handling biological materials. 
BACKGROUND OF THE INVENTION 
Heretofore, biological materials, such as samples generated for diagnostic 
testing, have been shipped in foam, e.g., polystyrene foam, cases 
comprising two portions having cavities or openings for receiving 
individual sample vials. The portions of the case may be fastened together 
to hold the vials inside, and the case may be placed in a conventional 
shipping box. While polystyrene foam cases may provide some shock 
absorbency to protect the samples, they do not sorb leaking fluid if one 
or more vials breaks. As a result, biological material may leak through 
the case and box, in which case persons handling the shipping boxes will 
also contact the material. 
U.S. Pat. No. 4,560,069 discloses a package for hazardous materials that 
includes a metal can, in which non-resilient and frangible foam elements 
are inserted for cushioning a bottle of such material and absorbing 
leakage if the bottle breaks. The foam elements are formed of open-celled, 
phenol-formaldehyde foam. Fiberboard spacers are provided to isolate the 
foam elements from the bottle to protect the foam. Because the foam 
elements are non-resilient and frangible, they will break down under 
impact or when crushed, with the result that their ability to absorb fluid 
is reduced when it is most needed. Moreover, in some cases, the leakage 
may only be detected after opening the can, for example, if the can is 
undamaged. 
Various other containers or bags for holding samples of materials include a 
bag employing ethyl cellulose as a sorbent disclosed in U.S. Pat. No. 
4,573,578; shipping bags having a layer of cushioning material disclosed 
in U.S. Pat. Nos. 3,768,724, 3,948,436 and 4,087,002; and a specimen 
mailer disclosed in U.S. Pat. No. 3,621,994 comprising nested plastic cups 
separated by resilient foam and a divider structure within the inner cup 
for holding four test tubes. U.S. Pat. No. 3,871,521 discloses a container 
comprising two shells filled with a foamed cellular polymer. 
SUMMARY OF THE INVENTION 
The present invention provides a containment device which is particularly 
useful for protecting sample containers used in diagnostic test kits from 
impact or mishandling during shipment, sealing the sample containers 
inside the device to prevent biological test samples from leaking from the 
device, and sorbing leakage from the containers due to breakage of or 
defects in the containers. 
Generally, a containment device of the invention is adapted for sealing and 
protecting containers of hazardous or biological materials. The 
containment device comprises a resilient cushion of aqueous fluid sorbent 
material having a plurality of openings. Each opening is adapted for 
receiving a respective container of hazardous or biological material, and 
the openings are arranged such that each opening is surrounded by 
sufficient sorbent material to sorb leakage of hazardous or biological 
material from its respective container if the container and/or if any 
additional containers break. A case of aqueous fluid resistant material is 
provided for receiving and enveloping the fluid sorbent material. The case 
includes two generally stiff-flexible portions having parts adapted for 
complementary interengagement and adapted to receive means for sealing the 
portions together to form an air and fluid tight package. 
Preferably, each portion of the case includes a base and a flange providing 
the parts and extending generally perpendicularly from the perimeter of 
the base. The flanges are adapted for overlapping interengagement, and 
tape is provided for holding and sealing the flanges together. Reinforcing 
means may also be provided adjacent the cushion for providing rigidity to 
the case. The reinforcing means includes a reinforcing strip of generally 
rigid material positioned between the flanges and the cushion, and the 
reinforcing strip is sized to maintain sufficient spacing between the 
bases of the portions of the case for the cushion to be received therein 
while permitting the flanges of the portions to overlap. 
Also, preferably, the cushion has sufficient aqueous fluid sorbent material 
around each opening to isolate each container from its nearest other 
containers so that if biological material leaks from one or more 
containers it will be isolated from the other containers. This may be 
accomplished, for example, by providing sufficient aqueous fluid sorbent 
material around each opening to afford a leak-sorbing safety factor of 
three or higher around each opening. The cushion may have a percentage 
void volume available for sorbing aqueous fluid of between approximately 
50 and 95 percent. The cushion may be formed of a nonwoven, fibrous 
polyolefinic material treated with a surfactant so that it is able to sorb 
aqueous fluids. 
A second aspect of this invention is a containment device adapted for 
sealing and protecting a container of hazardous or biological materials. 
The containment device comprises a resilient cushion of aqueous fluid 
sorbent material having an opening adapted for receiving a container of 
hazardous or biological material. The opening is surrounded by sufficient 
sorbent material to sorb leakage of hazardous or biological material from 
the container if it breaks. A case of aqueous fluid resistant material is 
provided for receiving and enveloping the fluid sorbent material. The case 
includes two generally stiff-flexible portions, and each portion has a 
base and a flange extending from the perimeter of the base. The flanges 
are adapted for overlapping interengagement and adapted to receive means 
for sealing the portions together to form an air and fluid tight package. 
Other features will be in part apparent and in part pointed out hereinafter 
.

DETAILED DESCRIPTION 
Now referring to the drawings, a containment device of the present 
invention is designated in its entirety by the reference numeral 10, and 
is particularly adapted for sealing and protecting containers, e.g., vials 
12A-H, holding biological or other potentially hazardous materials so that 
they may be shipped to a testing laboratory. 
As shown in FIG. 3, the containment device 10 generally includes a 
resilient, aqueous-fluid sorbent cushion generally designated 14, in which 
a plurality of openings 16A-H, 18 and 20 are formed. Openings 16A-H are 
adapted for receiving containers, e.g., the vials 12A-H, respectively, of 
biological material, and openings 18 and 20 are preferably adapted for 
receiving a hypodermic needle sheath 22 and vial-receiving barrel 24, 
respectively, so that the containment device 10 is capable of holding the 
necessary utensils for obtaining blood and urine samples. As used herein, 
"opening" refers to any type of space or cavity in the cushion for 
receiving such containers or utensils. The openings 16A-H are arranged 
such that each opening is surrounded by sufficient sorbent material 14 to 
sorb leakage of biological material from its respective container if the 
container and/or if any additional containers break. Openings 16A-H may be 
sized slightly smaller than the size of the vials 12A-H so that the 
cushion material surrounding each opening is slightly compressed to hold 
the vials in place, or, alternatively, the openings may consist of slits 
in the cushion 14 that are adapted to open sufficiently to accommodate the 
vials. A case 26 of aqueous fluid resistant material (e.g., polyvinyl 
chloride) is provided for receiving and enveloping the fluid sorbent 
material 14. The case 26 includes two generally stiff-flexible portions 
28A and B, constituting top and bottom portions, respectively, of the 
case. The portions 28A and 28B are preferably readily separable to provide 
access to the contents of the case, although the portions may be 
permanently or semi-permanently interconnected by, for example, a hinge 
(not shown) without departing from the scope of the present invention. The 
portions 28A, 28B of the case 26 have parts (e.g., flanges 30A and B) 
adapted for complementary and preferably overlapping interengagement. The 
flanges 30A and B are also adapted to receive means, such as adhesive tape 
32, for sealing the portions 28A and B together to form an air and fluid 
tight package, it being observed that one advantage of providing an air 
tight seal is that the case 26 functions similarly to an air cushion to 
further protect the vials. 
The portions 28A, 28B of the case 26 in addition to the flanges 30A, 30B, 
include generally planar bases 34A and 34B, respectively, having generally 
rectangular perimeters. The flanges 30A, 30B extend generally 
perpendicularly from the perimeters of their respective bases 34A, 34B in 
such a manner that they are adapted for overlapping inner-to-outer surface 
interengagement when the portions 28A and 28B are brought together to 
enclose the cushion 14. The tape 32 is centered with respect to the 
overlapped portions of the flanges 30A, 30B, and applied to the flanges to 
hold them in position and to seal them together. It will be observed that 
the overlap of the flanges 30A, 30B also serves to increase the rigidity 
of the case 26. The portions 28A, 28B of the case 26 may be vacuum-molded 
of 0.25-1.3 mm thick sheets of plasticized polyvinyl chloride, which are 
preferably generally transparent or translucent so that leakage from the 
containers may be observed without opening the case. Diagonal ribs 33 may 
be molded in the bases 34A, 34B to provide additional rigidity to the case 
26. 
Reinforcing means (e.g., reinforcing strip 36) may be provided adjacent the 
cushion 14 to increase the rigidity of the case 26. The reinforcing strip 
36 is formed of generally rigid material (e.g., generally rigid 0.5 mm 
thick fiberboard or cardboard), and is positioned between the flanges 30A, 
30B and the cushion 14, thereby providing a rigid backing for the flanges 
to facilitate applying the tape 32 thereto. The reinforcing strip 36 is 
sized to maintain sufficient spacing between the bases 34A, 34B of the 
portions 28A, 28B of the case 26 for the cushion 14 to be received therein 
without being crushed while permitting the flanges 30A, 30B of the 
portions to overlap. For example, if the desired thickness of the cushion 
14 is about 40 mm, the reinforcing strip 36 may have a width W of 
approximately 40 mm, and the flanges may each have a width of 
approximately 28 mm so that the flanges have about 16 mm of overlap when 
the portions 28A, 28B are brought together. The reinforcing means may also 
include one or more reinforcing sheets (not shown) positioned between one 
or both of the bases 34A, 34B and the cushion 14 to further increase the 
rigidity and puncture resistance of the case 26. The reinforcing sheets 
may be formed of material similar to that of the case 26. A tubular 
shipping box 38 having a rectangular cross section may also be provided 
for receiving the case 26 and protecting it. 
The cushion 14 preferably has sufficient aqueous fluid sorbent material 
around each opening 16A-H to isolate each container 12A-H from its nearest 
other containers so that if biological material leaks from one or more 
containers it will be substantially completely sorbed in the material and 
isolated from the other containers. Most preferably, sufficient aqueous 
fluid sorbent material is provided around each opening 16A-H to afford a 
leak-sorbing safety factor of three or higher around each opening. As 
illustrated in FIG. 6, this may be accomplished by calculating the 
cross-sectional area X of the vial, multiplying the area X by the safety 
factor three, and dividing the result by the percentage void volume of the 
sorbent material available for sorbing fluid to determine the minimum 
annular cross-sectional area Y of sorbent material required around the 
opening. The cross-sectional area Y may be used to determine the minimum 
dimension D of material enveloping or surrounding the vial along its 
length and adjacent its ends (e.g., dimension D equals the radius of area 
Y minus the radius of a cylindrical vial). This calculation is performed 
for each size vial, and the amount of sorbent material surrounding each 
opening is provided accordingly, it being understood that adjacent 
vial-receiving openings are spaced by a distance at least as great as the 
sum of their minimum dimensions D. 
The cushion 14 is formed of nonwoven, fibrous polyolefinic (e.g., 
polypropylene) material having a percentage void volume available for 
sorbing fluid of between approximately 50 and 95 percent and treated with 
a surfactant (e.g., sodium sulfosuccinic acid) so that it is capable of 
sorbing aqueous fluid in addition to many other fluids. For example, the 
cushion 14 may be formed of melt blown microfiber material, similar to 
that described in coassigned U.S. Pat. No. 4,118,531 and/or such as the 
universal sorbent sold under the trademark "Powersorb" by Minnesota Mining 
and Manufacturing Company of St. Paul, Minnesota. Discrete solid entities 
(e.g., particles, fibers, etc.) formed of superabsorbent polymeric 
material and/or deactivating or disinfectant material can be uniformly 
dispersed in the cushion material, as described in coassigned U.S. Pat. 
Nos. 3,971,373 and 4,429,001, so that they are adapted to interact with 
any aqueous fluid material and/or biological material which leaks into the 
cushion 14. 
The cushion 14 preferably includes a plurality (e.g., three) of sheets 
40A-C of "Powersorb" brand universal sorbent material secured or glued 
together in face-to-face relationship, in which the openings 16A-H, 18 and 
20 are formed. Two sheets 42A, 42B of such sorbent material, in which no 
openings are formed, are secured or glued to the respective bases 34A, 34B 
of the portions 28A, 28B of the case 26. Sheets 40A-C may be glued to the 
sheet 42B that is secured to the base 34B of the bottom portion 28B so 
that when the top portion 28A is separated from the bottom portion, sheets 
40A-C, vials 12A-H, hypodermic needle sheath 22 and vial-receiving barrel 
24 remain in the bottom portion 28B of the case. Alternatively, a single 
thick pad (not shown) of such sorbent material may be provided in lieu of 
the three intermediate sheets 40A-C of material. 
FIG. 7 illustrates another embodiment of the invention wherein a cushion 
14A includes separable top and bottom sections 44T and 44B, in which a 
plurality of staggered openings 46A-F are formed for receiving containers 
or vials 48A-F, respectively, of biological material. More specifically, 
the top section 44T of the cushion 14A may have three openings 46A-C that 
are staggered with respect to the openings 46D-F of the bottom section 44B 
so that less sorbent cushion material is required to isolate the vials 
from one another. The top and bottom sections 44T, 44B of the cushion 14a 
are adapted for face-to-face interengagement to isolate the containers 
from one another. The openings 46A-F are preferably sized slightly smaller 
than the size of the vials 48A-F so that the vials do not fall from the 
cushion when the case 26A is opened. 
As various changes could be made in the above constructions without 
departing from the scope of the invention, it is intended that all matter 
contained in the above description or shown in the accompanying drawing 
shall be interpreted as illustrative and not in a limiting sense.