U.S. patent application number 10/155241 was filed with the patent office on 2003-05-08 for shipping containers and methods for the transportation of materials at stable temperatures.
Invention is credited to Charlton, Kim E., McBee, Fred, Ogilvie, Penny T..
Application Number | 20030084679 10/155241 |
Document ID | / |
Family ID | 26852139 |
Filed Date | 2003-05-08 |
United States Patent
Application |
20030084679 |
Kind Code |
A1 |
Charlton, Kim E. ; et
al. |
May 8, 2003 |
Shipping containers and methods for the transportation of materials
at stable temperatures
Abstract
This invention relates to shipping containers and methods for
the transportation perishable or temperature-sensitive materials at
stable temperatures. Materials within the container are maintained
in a narrow temperature range by a passive temperature control
device. The device and the perishable materials are placed in the
container, separated by a structured barrier. Structured barriers
comprise materials of predefined thickness and placed so that
perishable materials do not come into direct contact with the
temperature-control device, but has a plurality of notches that
allow for limited air circulation. Preferably the assembled
container is covered with a fitted lid to minimize temperature
transfer between the outside and inside of the container.
Inventors: |
Charlton, Kim E.;
(Nashville, TN) ; McBee, Fred; (Knoxville, TN)
; Ogilvie, Penny T.; (Franklin, TN) |
Correspondence
Address: |
HELLER EHRMAN WHITE & MCAULIFFE LLP
SUITE 300
101 ORCHARD RIDGE DR.
GAITHERSBURG
MD
20878-1917
US
|
Family ID: |
26852139 |
Appl. No.: |
10/155241 |
Filed: |
May 28, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60306865 |
Jul 23, 2001 |
|
|
|
Current U.S.
Class: |
62/371 ;
62/457.2 |
Current CPC
Class: |
F25D 2600/04 20130101;
F25D 2303/082 20130101; F25D 3/08 20130101; F25D 2331/804
20130101 |
Class at
Publication: |
62/371 ;
62/457.2 |
International
Class: |
F25D 003/08 |
Claims
1. A shipping container comprising: a container have a single
opening leading to an inner chamber; a structured barrier within
the inner chamber that allows for limited air circulation across
said structured barrier; a temperature-control device placed in the
chamber on one side of the barrier; and a fitted lid that securely
covers said opening.
2. The container of claim 1 wherein the container is composed of
styrofoam.
3. The container of claim 1 wherein the structured barrier is
comprised of a light-weight material selected from the group
consisting of foam, neoprene, plastics, cardboard, rubber,
styrofoam and combinations thereof.
4. The container of claim 1 wherein the structured barrier contains
a plurality of notches or openings that allows limited air
circulation between a plurality of inner chambers of the
container.
5. The container of claim 4, wherein said notches or openings
represent less than 20% of the cross-sectional area of the
container.
6. The container of claim 4, wherein said notches or openings
represent less than 10% of the cross-sectional area of the
container.
7. The container of claim 1 wherein the structured barrier contains
up to three notches.
8. The container of claim 1 wherein the structured barrier contains
up to three notches, wherein each of said notches are positioned at
a corner of said barrier.
9. The container of claim 1 wherein air circulation across the
structured barrier is less than 25%.
10. The container of claim 1 wherein air circulation across the
structured barrier is sufficient to maintain materials within said
chamber at a temperature range of 17.degree. C.+/-7.degree. C. for
at least 3 days.
11. The container of claim 1 wherein the temperature-controlling
device is an ice pack, liquid pack ,a gel pack, or a temperature
generating device.
12. The container of claim 1 wherein the container is comprised of
a light-weight material selected from the group consisting of foam,
neoprene, plastics, cardboard, rubber, styrofoam and combinations
thereof.
13. A shipping container comprising: a container means to house an
inner chamber; a barrier means within the inner chamber that allows
for limited air circulation across said barrier means; a
temperature-control means to control temperature in said chamber;
and a covering means to cover said inner chamber.
14. The container of claim 13 wherein the container means is
comprised of comprised of a light-weight material selected from the
group consisting of foam, neoprene, plastics, cardboard, rubber,
styrofoam and combinations thereof.
15. The container of claim 13 wherein the barrier means is
comprised of a light-weight material selected from the group
consisting of foam, neoprene, plastics, cardboard, rubber,
styrofoam and combinations thereof.
16. The container of claim 13 wherein the barrier means contains
circulating means that allows limited air circulation across the
barrier means.
17. The container of claim 13 wherein the circulating means
comprises notches or openings.
18. The container of claim 13 wherein the temperature-controlling
means is an ice pack, liquid pack, a gel pack, or a temperature
generating device.
19. The container of claim 13 wherein air circulating means
circulates air across the structured barrier sufficiently to
maintain materials within said chamber at a temperature range of
17.degree. C.+/-7.degree. C. for at least 3 days.
20. A method for transporting temperature-sensitive materials
comprising: placing said materials within a container; placing the
structured barrier on top of said materials; placing the
temperature-controlling device on top of the barrier; and securely
closing said container with the fitted lid.
21. The method of claim 20 wherein the container is comprised of
comprised of a light-weight material selected from the group
consisting of foam, neoprene, plastics, cardboard, rubber,
styrofoam and combinations thereof.
22. The method of claim 20 wherein the structured barrier is
comprised of a light-weight material selected from the group
consisting of foam, neoprene, plastics, cardboard, rubber,
styrofoam and combinations thereof.
23. The method of claim 20 wherein the structured barrier contains
a plurality of notches or openings that allows limited air
circulation between a plurality of inner chambers of the
container.
24. The method of claim 23 wherein said notches or openings
represent less than 20% of the cross-sectional area of the
container.
25. The method of claim 23 wherein said notches or openings
represent less than 10% of the cross-sectional area of the
container.
26. The method of claim 20 wherein the structured barrier contains
up to three notches.
27. The method of claim 20 wherein the structured barrier contains
up to three notches, wherein each of said notches are positioned at
a corner of said barrier.
28. The method of claim 20 wherein air circulation across the
structured barrier is less than 25%.
29. The method of claim 20 wherein air circulation across the
structured barrier is sufficient to maintain materials within said
chamber at a temperature range of 17.degree. C.+/-7.degree. C. for
at least 3 days.
30. The method of claim 20 wherein the temperature-controlling
device is an ice pack, liquid pack ,a gel pack, or a temperature
generating device.
31. The method of claim 20 wherein the container is comprised of a
light-weight material selected from the group consisting of foam,
neoprene, plastics, cardboard, rubber, styrofoam and combinations
thereof.
32. A method of maintaining materials at a temperature range of
17.degree. C.+/-7.degree. C. for at least 3 days comprising placing
said materials in a container comprising a structured barrier and a
temperature control device.
33. The method of claim 32 wherein the container is comprised of
comprised of a light-weight material selected from the group
consisting of foam, neoprene, plastics, cardboard, rubber,
styrofoam and combinations thereof.
34. The method of claim 32 wherein the structured barrier is
comprised of a light-weight material selected from the group
consisting of foam, neoprene, plastics, cardboard, rubber,
styrofoam and combinations thereof.
35. The method of claim 32 wherein the structured barrier contains
a plurality of notches or openings that allows limited air
circulation between a plurality of inner chambers of the
container.
36. The method of claim 35 wherein said notches or openings
represent less than 20% of the cross-sectional area of the
container.
37. The method of claim 35 wherein said notches or openings
represent less than 10% of the cross-sectional area of the
container.
38. The method of claim 32 wherein the structured barrier contains
up to three notches.
39. The method of claim 32 wherein the structured barrier contains
up to three notches, wherein each of said notches are positioned at
a corner of said barrier.
40. The method of claim 32 wherein air circulation across the
structured barrier is less than 25%.
41. The method of claim 32 wherein air circulation across the
structured barrier is sufficient to maintain materials within said
chamber at a temperature range of 17.degree. C.+/-7.degree. C. for
at least 3 days.
42. The method of claim 32 wherein the temperature-controlling
device is an ice pack, liquid pack, a gel pack, or a temperature
generating device.
Description
REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional
application No. 60/306,865, entitled "Shipping Containers and
Methods for the Transportation of Materials at Stable
Temperatures," filed Jul. 23, 2001.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to shipping containers and
methods for the transportation of biological materials at stable
temperatures. In particular, the invention relates to shipping
containers and methods for the transportation of biological
materials at relatively constant, stable temperatures.
[0004] 2. Description of the Background
[0005] Biological and other materials are often transported over
long distances using common carriers such as mail and express
courier services using land sea or air. Sending and receiving
locations can be miles or even continents apart with transportation
being by land (road or rail), sea or air carrier. All forms of
transportation carry a risk that the materials being transported
might be damaged or destroyed. With biological materials such as
blood, tissue and organs for transplantation, the risk is
considerably magnified and, the longer the distance, the higher the
risk. In addition, the shipping materials themselves can pose a
health risk if, for example, the materials contain an infectious or
hazardous substances.
[0006] There are many regulations from local and federal government
and international bodies, which seek to define safe shipping
standards. Pertinent federal regulations in the United States
include those set forth in titles 29, 39, 42 and 49 of the Code of
Federal Regulations. Particular agencies whose mission is concerned
with safe packaging and shipping standards are the International
Civil Aviation Organization/International Air Transport Association
(ICAO/IATA), United States Department of Transportation (DOT), U.S.
Center of Disease Control (CDC), U.S. Occupational Safety and
Health Administration (OSHA), United Nations (UN), and World Health
Organization (WHO). Specific standards that must be followed
include: Dangerous Goods Regulations of the International Air
Transport Association, 38th Edition, Jan. 1, 1997; Code of Federal
Regulations Title 49, Transportation Subtitle B, Other Regulations
Relating to Transportation, U.S. Dept. of Transportation Parts 172,
173, 176 and 178, Oct. 1, 1996; Biosafety in Microbiological and
Biomedical Laboratories, U.S. Dept. of Health and Human Services
Public Health Service (CDC and NIH), 3rd Edition May, 1993; Code of
Federal Regulations Title 42, Public Health U.S. Dept. of Health
and Human Services Part 72 Interstate Shipment of Etiologic Agents
Mar. 2, 1995; Hazardous Material Regulations Transportation Safety
Act of 1974, Consolidation of 1976 Pocket Guide, 1991; U.S. Dept.
of Health and Human Services Center for Devices and Radiological
Health, U.S. Food and Drug Administration, Generic Standard
Operating Procedure "Handling, Packaging, Transportation, Storage
and Sterilization of Medical Devices" October, 1994; U.S. Dept. of
Health and Human Services Occupational Safety and Health
Administration Section 3, Final Rules on Occupational Exposure to
Blood borne Pathogens; American Society for Testing and Materials
Proposed Documents for ISO/TC 150/WG5 "Retrieval and Analysis of
Implantable Medical Devices;" United Nations Documents Requirements
for Transportation of Hazardous Goods.
[0007] When transporting hazardous items, even if in full
compliance with all appropriate regulation, problems can arise as
to durability, rigidity, size, weight, cost, reusability, and
temperature stability of the container. These issues are especially
significant when the containers are required to be leak proof,
pressure resistant and/or maintain a proscribed temperature range.
Durability problems exist with rigid containers due to the
inevitable bangs, scrapes, dents and other permanent distortions
that can occur in handling during transport. Durability can also be
adversely affected by external environmental conditions such as
rain, snow and sun, which can compromise the integrity in the
container. In some cases, containers are required to be discarded
after one use or simply are unable to hold up to normal wear and
tear. To make such container reusable, expensive process would be
required to refurbish the container for reuse to meet original
specifications, performance criteria and/or appropriate
regulations.
[0008] One example of a shipping container suitable for use in the
transportation of hazardous materials is proposed in U.S. Pat. No.
5,996,799, which is incorporated herein by reference. In at least
one embodiment, the container comprises a multi-component
non-rigid, flexible structure to accommodate the particular item or
items to be transported. The container can be sized to specific
sizes and shapes of the items to be transported. This allows for a
smaller, less cumbersome, reduced weight container that costs less,
is easier to handle, and takes less space to store. The container's
non-rigid, flexible design enhances its durability, possibly
reducing damage caused during transport and increasing the
probability of reusability. Further, as the container can be
adaptable to have a closer net shape of the items to be
transported, costs associated with transportation and delivery. The
container can also be significantly more resistant to external
environmental depending on the materials used for its
construction.
[0009] Another problem is that containers can be very large in
comparison to the material or specimens to be transported. This
creates unnecessary manufacturing and materials cost as well as
increased costs for transportation. Lack of ability to match a
performance oriented container size to the size of the
materials/specimen can cause the transport to be unwieldy, heavier
than necessary, difficult to store and too large for its intended
purpose. More importantly, the increased size, which may be
necessitated by dry ice or other materials designed to keep the
materials at a constant temperature require additional space which
causes significant temperature fluctuations within the
container.
[0010] Containers with lids have the general characteristic of
top-down cooling (when considering the transportation of cooled
materials), which means that more heat seeps into the container
from the top as opposed to through the walls of the container, so
that the coolest areas of the container are opposite the lid in the
depths of the internal space of the container. This creates uneven
and uncontrollable temperature gradients between the top and bottom
of the container. Of course, this can present serious problems when
temperature directly affects the material being transported.
Top-down cooling also produces hot spots, wide temperature swings
and severe temperature gradients throughout the container.
[0011] The most common manner to transport heat-sensitive materials
is in refrigerated containers. Although large quantities of such
materials can be transported by artificial refrigeration for
prolonged periods of time, the costs of such apparatus and the
weight penalties incurred when air mail/freight is involved, are
prohibitive for anything but bulk transport. For smaller quantities
of materials, containers may be passively cooled, such as by
packing the container with cooling elements such as water ice or
dry ice (U.S. Pat. No. 6,119,465). Although effective for short
periods of time, long-distance transportation is a problem and the
weight of the cooling element adds considerably to the cost of
delivery through conventional delivery services.
[0012] One example of a passively cooled, self-contained
transportation container has been proposed for the transportation
of equine semen (U.S. Pat. No. 4,530,816 which is incorporated
herein by reference). In this arrangement, a specimen is enclosed
in a plastic bag and placed in a metal cup sandwiched between bags
of liquid, such as water, that act as so called thermal ballast.
The lower portion of the container is filled with a refrigerant
such as ice or gelatinized ice. A thermal insulating layer, made of
a vulcanized rubber, is disposed between the refrigerant and the
metal cup in which the sample and the thermal ballast bags are
disposed. The optimum steady state temperature is close to, but
slightly greater than, freezing, with a temperature range of from
4.degree. C. to 10.degree. C.
[0013] Thus, there is a strong need for a shipping container and
related method that can transport materials that require stable
temperatures and must be maintained within a defined temperature
window. Such a container and method preferably should meet both
general and specific requirements and testing protocols of national
and international regulations for modes of transportation for air,
sea, rail and highway. Such a container should be durable,
lightweight, and preferably reusable, with the capability of
transporting hazardous and/or potentially infectious materials in
leak proof container that meets applicable criteria.
SUMMARY OF THE INVENTION
[0014] The present invention overcomes the problems and
disadvantages associated with current strategies and designs and
provides new containers for shipping materials at stable
temperatures. In particular, the invention relates to containers
for shipping biological and other perishable materials at
temperatures whereby the materials are not damaged.
[0015] One embodiment of the invention is directed to a shipping
container for the transportation of perishable or
temperature-sensitive materials at relatively constant
temperatures. Materials within the container are maintained in a
narrow temperature range by a passive temperature control device.
Such devices are commercially available, but may be custom designed
for a particular container or material. The device and the
perishable materials are placed in the container, separated by a
structured barrier. Structured barriers are of a predefined
thickness so that the perishable materials therein do not come into
direct contact with the temperature control device, but allow for
limited air circulation. Preferably, the structured barrier
contains a plurality of notches for air circulation. The container
is covered and, preferably, the lid is fitted to minimize the
possibility of accidental opening and temperature transfer between
the outside and inside of the container.
[0016] Another embodiment of the invention is directed to methods
for the transportation of temperature-sensitive materials. Methods
comprise placing the materials in a container of suitable size and
structure, and having one opening which leads into an inner
chamber. Within the container is also placed a temperature-control
device at a predetermined temperature, which is separated from the
materials by a pouch made of insulative material. The pouch allows
for limited air circulation, and prevents direct contact between
the device and the materials. Once the contents are assembled
within, a lid, preferably fitted, is placed over the one opening.
Now completely assembled, the container can be delivered to a
desired location.
[0017] In a preferred embodiment, the invention provides a shipping
container comprising: a container have a single opening leading to
an inner chamber; a structured barrier within the inner chamber
that allows for limited air circulation across said structured
barrier; a temperature-control device placed in the chamber on one
side of the barrier; and a fitted lid that securely covers said
opening.
[0018] Preferably, the container is composed of styrofoam.
[0019] Preferably, the structured barrier is comprised of a
light-weight materialn selected from the group consisting of foam,
neoprene, plastics, cardboard, rubber, styrofoam and combinations
thereof.
[0020] Preferably, the structured barrier contains a plurality of
notches or openings that allows limited air circulation between a
plurality of inner chambers of the container.
[0021] Preferably, the structured barrier contains three
notches.
[0022] Preferably, air circulation across the structured barrier is
less than 25%.
[0023] Preferably, the temperature-controlling device is an ice
pack, liquid pack ,a gel pack, or a temperature generating
device.
[0024] In another preferred embodiment, the invention provides a
method for transporting temperature-sensitive materials comprising:
placing said materials within the container of the instant
invention; placing the structured barrier on top of said materials;
placing the temperature-controlling device on top of the barrier;
and securely closing said container with the fitted lid.
[0025] In a preferred embodiment, the container maintains said
materials within a temperature range of 17.degree. C.+/-7.degree.
C. for at least 3 days.
[0026] In another preferred embodiment, the invention provides a
shipping container comprising: a container means to house an inner
chamber; a barrier means within the inner chamber that allows for
limited air circulation across said barrier means; a
temperature-control means to control temperature in said chamber;
and a covering means to cover said innerchamber.
[0027] Other embodiments and advantages of the invention are set
forth in part in the description which follows, and in part, will
be obvious from this description, or may be learned from the
practice of the invention.
[0028] Other objects, features and advantages of the present
invention will become apparent from the following detailed
description. It should be understood, however, that the detailed
description and the specific examples, while indicating preferred
embodiments of the invention, are given by way of illustration
only, since various changes and modifications within the spirit and
scope of the invention will become apparent to those skilled in the
art from this detailed description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0029] The accompanying drawings, which are incorporated in and
constitute a part of the specification, illustrate a presently
preferred embodiment of the invention, and, together with the
general description given above and the detailed description of the
preferred embodiment given below, serve to explain the principles
of the invention. Thus, for a more complete understanding of the
present invention, the objects and advantages thereof, reference is
now made to the following descriptions taken in connection with the
accompanying drawings in which:
[0030] FIG. 1 An open shipping container of one embodiment
displaying components of the invention: a styrofoam container,
vials of blood, a leak proof bag, a structured barrier, a gel pack
and a fitted lid.
[0031] FIGS. 2a, 2b, 2c Perspectives of a preferred container.
[0032] FIG. 3A top perspective of a preferred container.
[0033] FIGS. 4a, 4b, 4c Perspectives of a preferred lid.
[0034] FIG. 5a, 5b Perspectives of a preferred barrier.
[0035] FIG. 6A schematic of a preferred arrangement of: container;
barrier; biological material; temperature controlling device; and
lid.
[0036] FIG. 7 Test of frozen gel packs to maintain internal
temperature range (ITR).
[0037] FIG. 8 Kit configuration incorporating a neoprene pouch to
maintain internal temperature range (ITR).
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0038] As embodied and broadly described herein, the present
invention is directed to containers for shipping materials at
stable temperatures. In particular, the invention relates to
containers for safely shipping biological materials such as blood
and other perishable materials within predetermined temperature
ranges.
[0039] Biological and other perishable materials are often
transported over long distances using common carriers. For
materials that must remain cool or cold, bulk refrigeration is
generally required. Many materials cannot be transported by bulk,
and require individually cooled containers. In most cases, these
containers are passively cooled using frozen gel packs or other
commercially available devices. Although effective, the increased
costs associated with inclusion of the cooling materials are
considerable. In addition, many materials have a limited life in
such containers. The temperature window or temperature range at
which the materials must be maintained is fairly narrow and often
above freezing. This is particularly true with regard to biological
specimens that are required to be sent to distant laboratories for
medical testing.
[0040] It was surprisingly discovered that, utilizing the shipping
container and method of the invention, temperature-sensitive
materials can be transported over long distances within passive
temperature controls. Temperature control is achieved by
incorporating a temperature-control device (e.g. a gel pack, ice
pack, neoprene, warm pack or other temperature producing device),
structured barrier that allows for limited air circulation and
prevents direct contact between the materials and the
temperature-control device, and a container with a single opening
secured with a fitted lid.
[0041] In a preferred embodiment of the invention, the
temperature-sensitive materials are placed at the bottom of an
appropriately sized container. Containers should be designed to
have a minimum of open space, such that substantially all space
within the container contains materials for transportation with
little free space. Any size or configuration of container may be
used, and preferably is configured for the contents being
transported. The most typical configuration is square or
rectangular.
[0042] The desired material to be transported may be contained in a
biohazard bag or other flexible pouch for safety reasons, and/or to
prevent contact with air, water or water vapor.
[0043] A structured barrier, preferably comprising a light-weight
material that allows for air circulation around the barrier is
placed on top of the materials substantially filling the
cross-sectional area of the inner chamber of the container.
[0044] Suitable materials that can be used for the barrier include,
but are not limited to, cardboard, rubber, neoprene, foam (of
appropriate density), paper, wood, styrofoam, composites, plastic
and the like. The barrier prevents direct contact of the
temperature-sensitive materials to the passive-cooling device.
[0045] In a preferred embodiment, the barrier is appropriately
structured with ventilation openings to allow for a limited amount
of air circulation across the barrier. Openings may represent up to
20% of the cross-sectional area of the container. Openings
preferably represent less than 20%, more preferably less than 10%
of the cross-sectional area of the container.
[0046] Structured barriers may have a single opening or a plurality
of openings at various points over the barrier. For example, a
square or rectangular barrier may have a plurality of notched
corners representing an opening for air circulation.
[0047] In a preferred embodiment, the barrier comprises notched
corners for air circulation across the barrier. Preferably, there
are three notched corners and one un-notched corner. The notches
are formed of a sufficient size and shape to permit limited air
circulation, but still allow the barrier to effectively shield the
temperature-sensitive materials from the temperature-controlling
device. In this manner, temperatures within the container are held
relatively constant (temperature windows), for example, over a
20.degree. C. range, over a 15.degree. C. range, over a 5.degree.
C. range, and preferably over a 10.degree. C. range (e.g. 0.degree.
C.+/-5.degree. C.; 17.degree. C.+/-10.degree. C.; 24.degree.
C.+/-15.degree. C.; 37.degree. C.+/20.degree. C.), for the
appropriate period of time.
[0048] Generally, transportation times for using the container of
the invention, over which temperature windows can be maintained,
are greater than one day, and preferably greater than two days.
[0049] A temperature-controlling device such as, for example, foam,
chemical warming or cooling devices, liquid pack or a gel pack, all
of which are commercially available, or other passive
temperature-controlling device may be placed on top of the
barrier.
[0050] The container is secured with a lid, preferably a fitted
lid. The fitted lid minimizes the risk of accidental opening of the
container, and also minimizes the amount of air circulation, and
therefore temperature transfer, between the outside and inside of
the closed container. The lid may be removable or, alternatively,
hingedly or lachingly attached to the container. Other materials,
such as shipping, regulatory or other documents or indicia may be
placed on or in the container as desired.
[0051] Temperature-sensitive materials that can be transported
using the shipping container of the invention include, but are not
limited to, tissues, cells, bodily fluids such as blood, whole
organisms, artificial implants, pathogens, bacteria, organs,
infectious substances, and temperature-sensitive chemicals and
toxins, and pharmaceutical products such as drugs and vaccines, and
combinations thereof.
[0052] Preferably, containers are designed for a broad spectrum of
users and require no special skill or training for assembly.
Directions may be included in or with containers to provide
preferred assembly instructions and instructions for emergency
situations such as accidental leaks or punctures of the container.
Thus, shipping containers of the invention are very useful for
obtaining biological specimens from patients in a home, clinic or
hospital setting. Nurses or other healthcare practitioners can
obtain a desired biological specimen from the patient and
immediately package the specimen for delivery to a clinical testing
or other facility for analysis. For example, blood and urine is
often collected from patients for routine physicals and insurance
examinations. Once isolated, vials of blood and urine, may be
packaged in a flexible biohazard pouch for protection from
accidental leakage and biohazard containment as may be required by
governmental regulation. Alternatively, vials may be placed in
support structures (which may also be encased in a flexible pouch
as desired) such as tube holders, tray holders and the like, which
may form a part of the interior of the container or be separate
components. The specimens are next placed into the bottom of a
shipping container. On top of the specimen is placed a structured
barrier for maintaining a near constant temperature environment
within the container.
[0053] Thickness of the barrier is determined by insulative
properties of the container and the temperature requirements of the
materials being shipped. The thickness of the barrier is generally
between about 2 and 50 mm, and preferably between about 10 mm about
20 mm. The barrier substantially fills the cross sectional area of
the inner chamber of the container and further contains a plurality
of notches or openings allowing limited air circulation. For square
or rectangular containers, barriers may also be rectangular or
square. Preferably, such barriers have three notched corners,
representing an opening of between about less than 20% of the
cross-sectional area of the container, allowing limited air
circulation across the barrier. A temperature-control device is
placed on top of the barrier which may be a cooling device, such
as, for example, a frozen or cooled gel pack for when outside
temperatures are elevated above a desired range, or a room
temperature gel pack to maintain a relatively constant temperature
within the container when outside air temperatures are cooler than
the desired temperature range. Alternatively, vials may be placed
in a neoprene pouch to maintain a narrow temperature range during
transportation. After assembly, the container is covered with a
fitted lid to secure the contents and limit air circulation. Once
fully assembled, containers can be transported over long distances
without significant risk to the integrity of the contents.
[0054] The preferred embodiments of the present invention and its
advantages are understood by referring to the Figs. of the
drawings, wherein like numerals being used for like and
corresponding parts of the various drawings.
[0055] FIG. 1 depicts a preferred embodiment of the invention which
is an open shipping container displaying components of the
invention: a styrofoam container 60, vials of blood 61, a leak
proof bag 62, a structured barrier 63, a gel pack 64 and a fitted
lid 65. In this way, the invention also includes kit for
transporting biological materials. Accordingly, the kit may contain
written material for safe and effective use of the instant
container. For example, the barrier may include instructions
indicting that the barrier is be placed between the specimen and
the temperature control device. Also, bag 62 may preferably contain
instructions, warnings or other indicia 66 related to storing,
using, or transporting any desired biological material to be
transported. Similarly, in a preferred embodiment, the invention
also includes instructions or other indicia 67 on storing, using,
or transporting the instant container or its contents. The
instructions may fit inside the container or be attached to the
container or barrier.
[0056] FIGS. 2a, 2b, 2c, and FIG. 3 show different perspectives of
container 1 has a body portion 2. The body may be constructed of
any suitable material such as styrofoam having outer wall 8 and
inner wall 9. Alternatively, body portion 2 may be a double-walled,
blow-molded construction having outer wall 8 and inner wall 9,
between which may be an insulation material. In the example,
container 1 also comprises a floor portion 68 which is also formed
by outer wall 8 and inner wall 9.
[0057] It will be appreciated that FIG. 2c is a cross sectional
view of the container across the line defined by A and A'.
[0058] The body walls, floor and lid define a container volume or
chamber 16 for retaining articles such as a desired biological
material.
[0059] A lip portion 69 is formed around an opening 70 to chamber
16 for securely holding a fitted lid that covers opening 70.
[0060] Another preferred embodiment is shown with reference to
FIGS. 4a, 4b, and 4c, wherein different perspectives of the instant
lid portion are depicted. Specifically, the lid 71 may be formed of
the same or different material than the container portion 1 (FIGS.
2a, 2b, 2c, and FIG. 3), and is defined by a body 75 having an
inner surface 73 and an outer surface 74. The lid also may comprise
a rim portion 69 formed on the inner surface 73 for securely
holding the lid 71 on container portion 1. FIG. 4c is a cross
sectional view of the lid across the line defined by B and B'.
[0061] Another preferred embodiment is shown with reference to
FIGS. 5a and 5b, wherein different perspectives of the instant
barrier are depicted. The barrier 76, may be any material that
allows for air circulation around the barrier and is placed on top
of the materials substantially filling the cross-sectional area of
the inner chamber of the container. Preferably, materials that are
suitable for the barrier include cardboard, rubber, neoprene, foam
(of appropriate density), paper, wood, styrofoam, composites,
plastic and the like. The barrier prevents direct contact of the
temperature-sensitive materials to the passive-cooling device. The
thickness of the barrier 77 is generally between about 2 and 50 mm,
and preferably between about 10 mm about 20 mm.
[0062] Specifically, FIG. 5a shows a preferred embodiment wherein
the barrier 76 further comprises a plurality of notches or openings
77 allowing limited air circulation. Preferably, such barriers have
three notched corners 77, representing an opening of between about
5% and 15% of the cross-sectional area of the container, allowing
limited air circulation across the barrier. In the depicted
embodiment, the barrier 76 is rectangular or square for a
corresponding square or rectangular container. FIG. 5b is a cross
sectional view of the lid across the line defined by C and C'. The
barrier substantially fills the cross sectional area of the inner
chamber of the container and notches or openings 77 allowing
limited air circulation.
[0063] A particularly preferred embodiment of the instant invention
is shown in FIG. 6. It will be appreciated that FIG. 6 is a cross
sectional view of the container across the line defined by A and A'
in FIG. 2b, and shows a preferred arrangement of the container,
barrier, temperature-controlling device, lid and any desired
biological material to be transferred. Specifically, a biological
material such as vials of blood 78 are placed inside the container
1 on top of floor portion 68. A barrier 76 as is placed on top
biological material 78. The barrier preferably has three notched
corners 77, representing an opening of between about 5% and 15% of
the cross-sectional area of the container, allowing limited air
circulation (shown by arrows) across barrier 76.
[0064] Next, a temperature-control device, such as a frozen or
cooled gel pack 79, is placed on top of the barrier 76. A lid 71
then may be securely fitted on container portion 1. Besides being
removable, the lid 71 may also be hingedly and latchingly attached
to container portion 1.
[0065] Attached hereto as Appendix A is a "User's Guide" describing
and explaining the method of use for one embodiment of the
invention.
[0066] The following examples illustrate embodiments of the
invention, but should not be view as limiting the scope of the
invention.
EXAMPLES
Example 1
Container
[0067] Blood specimens from 20 volunteers were exposed to various
temperatures to determine the specific range of temperature to
which a sample could be exposed without affecting viability. A
temperature range of 50.degree. to 75.degree. Fahrenheit was
identified as the range of temperature that specimens could be
exposed. Several types and sized containers were evaluated to
achieve maximum insulation. Containers evaluated included:
Different weights of Styrofoam, polyurethane, thermos containers,
and thermal bags. Proto-types were tested by using continuous
recording temperature monitors. Styrofoam appeared to have very
good stability maintaining the identified range of temperature when
exposed to outside temperatures of 40.degree. to 80.degree.
Fahrenheit.
1 Polyfoam stock Pacific Packaging custom Specifications Styrofoam
Box Design Density of Styrofoam 3/4 lb. 1.5 lb. Interior dimension
6 .times. 41/2 .times. 3 inch 6 .times. 41/2 .times. 21/2 inch
Exterior dimension 8' .times. 61/2' .times. 5 inch 8' .times. 61/2'
.times. 41/2 inch Wall thickness 1/inch 1 inch Lid Inside Fit
Outside Fit
Example 2
Barrier
[0068] In order to maintain the identified internal temperature
range (ITR) when exposed to external temperatures above 80.degree.
Fahrenheit a cooling device was employed. Several types of frozen
gel packs were tested to maintain the ITR (See FIG. 7). During this
testing it was identified that placing the frozen gel directly on
the blood specimens caused damaged. A barrier between the frozen
gel and specimens was needed. Various types of materials were
tested. Materials tested included cardboard and various widths of
Styrofoam. Potassium was identified as the most sensitive analyte
when exposed to cold temperatures. Therefore potassium values were
used to evaluate the effectiveness of the barriers.
[0069] One inch Styrofoam proved to be good for allowing airflow
while preventing temperatures of the frozen gel pack to affect
specimens. However, When the Styrofoam barrier was cut to fit the
inside dimensions of the Styrofoam container, it did not allow
enough cooling to pass through to the blood specimens. Various
types of holes and notches in the Styrofoam barrier were tried.
After various trials, placing notches in three corners of the
barrier allowed for very good passive cooling without negatively
affecting analytes.
2 Barrier Comparisons Immediate No Cardboard Cardboard Foam
Styrofoam Spin Barrier Barrier 1 ply Barrier 2 ply Rubber 1 inch
4.1 5.3 6.2 4.5 6.3 6.3 3.7 4.2 3.6 3.1 4.1 5.2 3.6 4.4 3.3 3.9
3.6
[0070]
3 One inch Styrofoam Barrier Tests Non frozen gel 24 Frozen gel 24
Immediate Room temp 24 hour hour Spin hour Temp > 75.degree.
Temp > 75.degree. 4.3 4.6 8.5 4.6 3.9 4.0 7.2 4.1
[0071]
4 Barrier comparison (1/2 inch v. 1 inch) Krackle Cutters custom
Pacific Packaging custom Specifications Barrier Barrier Density of
3/4 lb. 1.5 lb. Styrofoam Thickness 1 inch 1/2 inch
[0072]
5 Test comparisons of one inch v. 1/2 inch Barriers Immediate spin
1.5 lb-1/2 inch 3/4 lb-1 inch 4.5 4.3 3.7 3.5 3.4 3.0
Example 3
Neoprene
[0073] At outside temperatures of 40.degree. Fahrenheit or below
the Kit was unable to maintain the ITR. Several devices were
evaluated for providing heat or better insulation. Examples of
devices evaluated included: chemical heat packs, isothermal
molecular insulation, containers made of neoprene, and foam. Heat
packs evaluated provided too much heat initially, and did not
maintain needed temperatures for the duration of transport. Use of
various insulators could not maintain stability. Neoprene of
various thickness' were tested. At a thickness of 5 mm a pouch made
of neoprene with a Velcro closure could maintain the ITR when blood
was placed in the pouch immediately after it was drawn.
6 Effect of Potassium results with Neoprene Neoprene pouch Specimen
Immediate temp outside Kit < 40.degree. F. Without Pouch 8H-799
4.0 3.9 6.9 9H-799 4.3 3.9 8.5
Example 4
Use of Chemical Cold Pack and Neoprene
[0074] The use of a frozen gel pack when temperatures are above
80.degree. F. can be cumbersome and in some cases not feasible for
nurses in the field. A secondary kit configuration addressed this
by incorporating a neoprene pouch. By inserting specimens into the
neoprene pouch the ITR remains stable at outside temperatures of up
to 90.degree. F. In addition, use of a chemical cooling pack
maintains the ITR at temperatures above 90.degree. F. (See FIG.
8).
[0075] Additional advantages, features and modifications will
readily occur to those skilled in the art. Therefore, the invention
in its broader aspects is not limited to the specific details, and
representative devices, shown and described herein. Accordingly,
various modifications may be made without departing from the spirit
or scope of the general inventive concept as defined by the
appended claims and their equivalents.
[0076] As used herein and in the following claims, articles such as
"the", "a" and "an" can connote the singular or plural.
[0077] All references cited herein, including all publications, and
all U.S. and foreign patents and patent applications as well as the
priority document, U.S. provisional application No. 60/306,865, are
specifically and entirely incorporated herein by reference. It is
intended that the specification and examples be considered
exemplary only, with the true scope and spirit of the invention
indicated by the following claims.
* * * * *