U.S. patent application number 11/278506 was filed with the patent office on 2007-02-08 for container for transporting temperature controlled items.
This patent application is currently assigned to American Thermal Wizards International, Inc.. Invention is credited to Clifford Glade, Jim Leclair, Randal Miller, Ray Sheppard, Kenneth Wagner.
Application Number | 20070028642 11/278506 |
Document ID | / |
Family ID | 37431728 |
Filed Date | 2007-02-08 |
United States Patent
Application |
20070028642 |
Kind Code |
A1 |
Glade; Clifford ; et
al. |
February 8, 2007 |
Container for Transporting Temperature Controlled Items
Abstract
A reusable container for transporting temperature controlled
items, which includes an outer case including a lid, and an
insulating layer substantially inside the outer case and the lid. A
generally rigid well is located inside the insulating later. At
least one cooling element is provided, which is capable of
maintaining temperature within a prescribed temperature range for
predetermined periods of time, the cooling element being disposed
within the well and at least partially defining a receptacle area.
A caddy can be located in the receptacle area, at least partially
surrounded by the cooling element, and is designed to accommodate
at least one item to be transported. The cooling element may
include a phase change material sealed within a plastic surround,
and is designed to be separately removable and freezable prior to
use. Temperature logging and/or location logging devices may be
included.
Inventors: |
Glade; Clifford;
(Islamorada, FL) ; Wagner; Kenneth; (Islamorada,
FL) ; Leclair; Jim; (Covington, GA) ; Miller;
Randal; (Peach Tree City, GA) ; Sheppard; Ray;
(Cooper City, FL) |
Correspondence
Address: |
AKERMAN SENTERFITT
P.O. BOX 3188
WEST PALM BEACH
FL
33402-3188
US
|
Assignee: |
American Thermal Wizards
International, Inc.
Miami
FL
|
Family ID: |
37431728 |
Appl. No.: |
11/278506 |
Filed: |
April 3, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11333194 |
Jan 17, 2006 |
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11278506 |
Apr 3, 2006 |
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11281548 |
Nov 17, 2005 |
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11333194 |
Jan 17, 2006 |
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60681769 |
May 17, 2005 |
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60681774 |
May 17, 2005 |
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60681770 |
May 17, 2005 |
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60682318 |
May 18, 2005 |
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Current U.S.
Class: |
62/371 ;
62/457.2 |
Current CPC
Class: |
F25D 3/06 20130101; A45C
5/14 20130101; A61B 90/98 20160201; A61J 1/165 20130101; A61B 50/10
20160201; A45C 15/00 20130101; A45C 13/02 20130101; A61B 50/00
20160201; A45C 11/20 20130101; F25D 2331/804 20130101; A45C 13/42
20130101; F25D 2400/38 20130101; A61B 2050/0014 20160201; F25D
2303/0831 20130101; A61B 50/13 20160201; A61B 50/31 20160201 |
Class at
Publication: |
062/371 ;
062/457.2 |
International
Class: |
F25D 3/08 20060101
F25D003/08 |
Claims
1. A container for transporting temperature controlled items
comprising: an outer case including a lid; an insulating layer
substantially inside the outer case and the lid; a generally rigid
well located inside the insulating layer disposed in the outer
case; at least one removable cooling element, the at least one
cooling element being capable of maintaining temperature within a
prescribed temperature range for predetermined periods of time upon
being kept at a predetermined temperature prior to use, the at
least one cooling element being disposable within the well and at
least partially defining a receptacle area; and a caddy locatable
in said receptacle area and designed to accommodate at least one
item to be transported, wherein said caddy is at least partially
surrounded by the at least one cooling element.
2. The container according to claim 1, further comprising a
temperature data-logging device for monitoring, collecting and
reporting data concerning the item being transported.
3. The container according to claim 1, wherein the cooling element
comprises cooling material disposed therein, the cooling material
comprising a phase change material.
4. The container according to claim 3, wherein the phase change
material is sealed within the cooling element.
5. The container according to claim 1, wherein the cooling element
at least partially comprises an ABS plastic.
6. The container according to claim 1, wherein the cooling element
is shaped so as to substantially surround the caddy.
7. The container according to claim 6, wherein the cooling element
comprises a bottom, side walls and at least one top portion,
wherein the top portion is hingedly attached to the side walls.
8. The container according to claim 1, wherein the cooling element
is removable from the container so as to be separately freezable
prior to use.
9. The container according to claim 1, wherein the outer case
further comprises means for lifting and towing the container.
10. The container according to claim 9, wherein the lifting and
towing means comprises at least one of a reinforced handle, a wheel
assembly, a telescopic handle, a non-retractable handle, and a
shoulder strap.
11. The container according to claim 1, wherein the outer case
further comprises of at least one information sleeve adapted to
hold identification information concerning the biological material
or pharmaceutical being transported.
12. The container according to claim 1, wherein the lid is hingedly
attached to the outer case and includes closing means for closing
the container.
13. The container according to claim 12, wherein the closing means
are selected from the group consisting of twist latches and at
least one zipper.
14. The container according to claim 1, wherein the caddy is
provided with at least one tamper resistant seal.
15. The container according to claim 1, wherein the insulating
layer is formed of polyurethane material.
16. The container according to claim 1, wherein the well is formed
of PE plastic.
17. The container according to claim 1, wherein the lifting means
of the inner caddy includes a handle.
18. The container according to claim 2, further comprising a
communications device capable of communicating temperature data to
a user.
19. The container according to claim 2, further comprising an alarm
to alert a user if the temperature recorded by the temperature
data-logging device falls outside a predetermined range.
20. The container according to claim 1, further comprising a
location detecting device for tracking the location of the
container during transport.
21. The container according to claim 20, further comprising a
communications device capable of communicating at least one of
temperature and location data to a user.
22. A container for transporting temperature controlled items
comprising: an outer case including a lid; an insulating layer
substantially inside the outer case and the lid; and at least two
cooling elements, the cooling elements each being capable of
maintaining temperature within a prescribed temperature range for
predetermined periods of time upon being kept at a predetermined
temperature prior to use, the cooling elements being disposed
within the insulating layer and each defining a receptacle area
designed to accommodate at least one item to be transported,
wherein each cooling element is designed to maintain an item
located within the receptacle area at a different predetermined
temperature.
23. The container according to claim 22, wherein each cooling
element includes a phase change material.
24. The container according to claim 22, further comprising a
temperature data-logging device for monitoring, collecting and
reporting data concerning the biological material or pharmaceutical
being transported.
25. A container for transporting temperature controlled items
comprising: an outer case including a lid; an insulating layer
substantially inside the outer case and the lid; a flexible foil
barrier positioned between the outer case and the insulating layer;
at least one cooling element, the at least one cooling element
being capable of maintaining temperature within a prescribed
temperature range for predetermined periods of time upon being kept
at a predetermined temperature prior to use, the at least one
cooling element being disposed within the flexible foil barrier and
at least partially surrounding a receptacle area; and a receptacle
located in said receptacle area and designed to accommodate at
least one item to be transported, wherein said receptacle is at
least partially surrounded by the at least one cooling element.
26. The container according to claim 25, further comprising a
second flexible foil barrier surrounding said receptacle.
27. The container according to claim 25, wherein the at least one
cooling element includes a phase change material.
28. The container according to claim 27, wherein the phase change
material is sealed within sealed within the cooling element.
29. The container according to claim 27, wherein the cooling
element at least partially comprises an ABS plastic.
30. A container for transporting temperature controlled items
comprising: an outer case including a lid; an insulating layer
substantially inside the outer case and the lid; and a removable
cooling element capable of maintaining temperature within a
prescribed temperature range for predetermined periods of time upon
being kept at a predetermined temperature prior to use, wherein the
cooling element is shaped so as to define a receptacle area
therein, into which at least one item for transportation may be
placed such that the item for transportation is substantially
surrounded by the cooling element.
31. The container according to claim 30, wherein the cooling
element includes a bottom, side walls and at least one lid portion,
the at least one lid portion being hingedly attached to at least
one side wall to allow access to the receptacle area defined within
the cooling element.
32. The container according to claim 30, wherein the cooling
element comprises phase change material disposed therein.
33. The container according to claim 32, wherein the phase change
material is sealed within the cooling element.
34. The container according to claim 30, wherein the cooling
element at least partially comprises an ABS plastic.
35. A method of transporting temperature controlled items
comprising the steps of: supplying a container having an outer case
including a lid; an insulating layer substantially inside the outer
case and the lid; at least one removable cooling element disposable
within the outer case and at least partially defining a receptacle
area that is at least partially surrounded by the at least one
cooling element; removing the at least one removable cooling
element from the container; cooling the at least one removable
cooling element for a predetermined period of time in a freezer,
refrigerator or other temperature controlled environment; replacing
the at least one removable cooling element in the container;
placing the item to be transported in the receptacle area defined
in the at least one cooling element; closing the container so as to
substantially surround the at least one cooling element by the
insulating layer; and transporting the biological material and/or
pharmaceuticals.
36. The method according to claim 35, wherein the at least one
removable cooling element is frozen for at least 24 hours prior to
replacement in the container for use.
37. The method according to claim 35, wherein the at least one
removable cooling element is conditioned after cooling and prior to
replacement in the container for use, by placing the cooling
element at room temperature for approximately 30 minutes.
38. The method according to claim 35, wherein the at least one
cooling element comprises cooling material sealed therein, the
cooling material comprising a phase change material.
39. The method according to claim 35, further comprising the step
of monitoring at least one of temperature within the caddy and
location of the container during transportation of the
container.
40. The method according to claim 35, further comprising the step
of inserting a standby cooling element into the receptacle to
maintain internal temperature conditions prior to placing the item
to be transported into the receptacle.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a Continuation-In-Part to U.S.
patent application Ser. No. 11/333,194 filed Jan. 17, 2006, which
was a Continuation-In-Part to U.S. patent application Ser. No.
11/281,548 filed Nov. 17, 2005 which claims priority to U.S.
Provisional Patent Application No. 60/681,769 filed May 17, 2005.
The present application also claims priority to U.S. Provisional
Patent Application No. 60/681,774 filed May 17, 2005, U.S.
Provisional Patent Application No. 60/681,770 filed May 17, 2005
and U.S. Provisional Patent Application No. 60/682,318 filed May
18, 2005. The entire disclosures of these earlier applications are
incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The invention relates generally to a container for
transporting temperature controlled items such as one or more of
biological material, biologics, pharmaceuticals, chemicals and food
products at a required temperature range.
BACKGROUND OF THE INVENTION
[0003] Transporting biological material such as blood and blood
products in a timely manner has always been a problem. Generally,
the health care industry has relied on the use of insulated
containers such as coolers developed and manufactured for the
recreational industry for keeping food and beverages cold. The
coolers that have been used to cool biological and related
materials have significant limitations. For example, they do not
address the need for documented temperature monitoring for blood
products for transfusions that the Food and Drug Administration
(FDA) requires as of 2004. Thus, the healthcare industry is in need
of a better solution for the transportation of biological material,
biologics and pharmaceuticals which require documented temperature
tracking for FDA compliance as well as better custom design
configurations that can focus specifically on physical requirements
of these critical payloads.
[0004] The term "biological material" as used herein is intended to
include but not to be limited to blood and blood products including
any type of human or animal blood, cells including stem cells, bone
marrow, donor organs, tissue products and samples, plasma
concentrates, reagents (including standards and controls) used to
assay biological functions, specimens and the like, and any other
biological products (including pharmaceuticals) that must be kept
within predetermined temperature ranges during transport and is not
intended to be interpreted in a narrow or limiting manner.
[0005] Spoilage and the risk of infection from temperature
compromised blood, blood products, tissues, cells or donor organs
are of paramount concern. The FDA requires that blood and blood
products taken out of storage and transported must be maintained at
transport temperature range of 1.degree. C. to 10.degree. C. which
compromises the time of acceptable use. Packed red blood cells and
blood products stored for a maximum use of 42 days must be kept
between 1.degree. C. and 6.degree. C. under constant temperature
monitoring at all times. Thus, keeping packed red blood cells
during transport at a monitored temperature range of 1.degree. C.
to 6.degree. C. meets these FDA standards for distribution and
negates variable transport conditions; fresh plasma thawed (for
use) requires storage temperature range of 1.degree. C. to
6.degree. C.; platelet concentrates must be maintained at
20.degree. C. to 24.degree. C.; fresh frozen plasma must be stored
at or below -25.degree. C.; and tissue and organs must be kept at
2.degree. C. to 6.degree. C. Biologics such as vaccines and
injectable medications, and other pharmaceuticals may also have
requirements for transportation and storage at certain
temperatures. For example, the FluMist.TM. vaccine, which contains
the live influenza virus, should be continuously stored at less
than -15.degree. C. in order to maintain full potency.
[0006] Additionally, transporting biological material requires that
certain protocols and governing standards be met in order to
prevent exposure, damage or contamination while in transit.
Healthcare professionals try to solve this problem by transporting
blood and blood products in a leak-proof primary container placed
in a secondary container, such that the specimen is protected from
inadvertent puncture or contamination. The blood and blood products
are then packed on wet or dry ice or a chemical coolant to be
transported in Styrofoam.RTM. containers. In some parts of the
world Styrofoam.RTM. must exported back to its place of origin due
to strict environmental regulations.
[0007] However, one of the limitations of this method of
transportation is that wet ice is messy, often spills during
transportation, and re-icing while in transit is sometimes
challenging in remote areas. Dry ice offers its own complications
as it can be hazardous; for example, loose dry ice can
inadvertently touch the blood or blood product, causing it to
freeze the blood or blood product at the area of contact and damage
the entire product. Furthermore, if dry ice is placed in a
non-vented container, it will explode, and so care must be taken to
vent the container. Concentrations of CO.sub.2 can also build up to
harmful levels inside the container as the dry ice transforms to
its gaseous form. Additionally, dry ice is sometimes unavailable in
certain parts of the world, and is difficult to handle as it can
burn the skin of a user. These factors only serve to further limit
the ability to transport blood and blood products for prolonged
periods. To alleviate this problem, frozen gel packs have been used
to help maintain required temperatures. However, gel packs are
susceptible to leaks and can therefore be unreliable. Additionally,
it is difficult to maintain a consistent temperature within the
entire blood or blood product with gel packs, since standard-sized
gel packs are not customized and move around during shipment.
[0008] Another limitation is that the blood and blood products and
other biological material, biologics or certain pharmaceuticals
need to be maintained at the required temperature over prolonged
periods when transported. The same is true for other temperature
controlled items, such as foodstuffs and chemicals which need to be
maintained at predetermined temperatures in order to maintain
freshness or potency. Conventional insulated shipping containers do
not address this problem, which can be further complicated when the
items are being transported internationally. Thus, there still
exists a need to be able to transport temperature controlled items
such as biological material, biologics, pharmaceuticals and other
items efficiently and safely for periods lasting longer than eight
to twelve hours without the use of either wet or dry ice, or
standard gel packs in a durable, reusable container that is capable
of maintaining and monitoring the temperature in transit for
compliance with certain protocols and for support documentation of
the lot numbers during transit for regulatory compliance.
[0009] The transportation of platelet concentrates is particularly
problematic, because of the need to keep such concentrates within a
temperature range between 20.degree. C. and 24.degree. C. Such
temperature ranges are very difficult to maintain using dry or wet
ice, or gel packs, which tend to cool the product too much. The
current solutions for the transportation of platelet products
include packing the containers with gel packs that are warmed to
room temperature, and surrounding the products with several layers
of insulation. The resulting packages are bulky, and there is also
no way to ensure that the temperature stays constant through
different weather conditions (and varying ambient temperatures in
hospitals and laboratories) that the package may be transported.
Platelet concentrates are typically transported in lots of 5, with
5, 10, 15 or 20 as the usual shipment.
[0010] There are additionally problems with the transportation of
various foodstuffs, such as prepared food, fish and seafood, and
other perishables including poultry, meats, and dairy products, in
that food safety and taste can be severely compromised if the food
is not transported at a reduced temperature. Fresh flowers are also
typically transported at a reduced temperature in order to retain
the freshness of the flowers for as long as possible. Various other
products also need to be kept within a defined temperature range
during transportation, and it is desirable to provide a suitable
container for transport of all such products.
SUMMARY OF THE INVENTION
[0011] The invention is directed to a reusable container for
transporting temperature controlled items such as biological
material, pharmaceuticals, food, chemicals and other products,
providing the ability to not only transport, but also to monitor
and maintain the temperature controlled items at the necessary
temperature range for more than (for example) twenty-four hours
without the use of wet or dry ice, or standard gel packs.
[0012] In one arrangement, the container comprises an outer case
including a lid, an insulating layer substantially inside the outer
case and the lid, and a generally rigid well located inside the
insulating layer. A least one removable cooling element is
included, the at least one cooling element being capable of
maintaining temperature within a prescribed temperature range for
predetermined periods of time upon being kept at a predetermined
temperature prior to use, the at least one cooling element being
disposable within the well and at least partially defining a
receptacle area. A caddy is locatable in the receptacle area and
designed to accommodate at least one item to be transported,
wherein the caddy is at least partially surrounded by the at least
one cooling element.
[0013] In another arrangement, a container for transporting
temperature controlled items comprises an outer case including a
lid, an insulating layer substantially inside the outer case and
the lid, and at least two cooling elements, the cooling elements
each being capable of maintaining temperature within a prescribed
temperature range for predetermined periods of time upon being kept
at a predetermined temperature prior to use, the cooling elements
being disposed within the insulating layer and each defining a
receptacle area designed to accommodate at least one temperature
controlled item. Each cooling element is designed to maintain the
item located within the receptacle area at a different
predetermined temperature.
[0014] In a further arrangement, a container for transporting
temperature controlled items includes an outer case including a
lid, an insulating layer substantially inside the outer case and
the lid, and a flexible foil barrier positioned between the outer
case and the insulating layer. At least one cooling element is
included, the at least one cooling element being capable of
maintaining temperature within a prescribed temperature range for
predetermined periods of time upon being kept at a predetermined
temperature prior to use, the at least one cooling element being
disposed within the flexible foil barrier and at least partially
surrounding a receptacle area. A receptacle is located in said
receptacle area and designed to accommodate at least one
temperature controlled item, wherein the receptacle is at least
partially surrounded by the at least one cooling element.
[0015] The container can include a waterproof outer case, which may
be constructed from hard, durable, rustproof material or a soft,
flexible, lightweight material that is durable and stain resistant.
The outer case provides for varied means for lifting and towing the
container, which may be singularly employed or in combination
thereof, for example a reinforced handle on the top of the
container, wheels, a telescopic handle, non-retractable handles and
shoulder straps.
[0016] The exterior of the container can contain at least one
information sleeve adapted to hold identification information
concerning the item being transported. For example, for the
transport of blood or blood products, a patient's name, social
security or identification number, surgeon, blood type, date the
blood or blood product left the blood bank, scheduled date of
delivery, number of units of blood, delivery operating room number,
surgeon, doctor and medical procedure can be documented and stored
in the information sleeve.
[0017] The cooling element is an important feature of the container
in accordance with the present invention. The cooling element can
include four modular units shaped and sized to securely fit the
top, bottom and sides of the inner perimeter of the well and are
adapted to form a receptacle area for housing an inner caddy.
Alternatively, the cooling element can be in one piece and can
include a bottom, side walls and at least one top portion, wherein
the top portion is hinged to the side walls. The cooling element is
responsible for keeping the inner caddy at the required temperature
(for example, 1.degree. C. to 6.degree. C.), and is made from
strong, durable and lightweight material, such as ABS plastic. A
cooling material is disposed in all or part of the cooling elements
and may include a phase change material. The cooling element is
adapted, when frozen and conditioned, to maintain the required
temperature for extended periods of time, i.e. 24+hours. The
cooling elements can be frozen prior to each day's use in any
standard or commercial freezer for up to 24 hours prior to each
use. The cooling elements are stackable and provide for easy
storage in a freezer. After removal from the freezer, the cooling
elements can be conditioned prior to use and insertion into the
container. The object of conditioning the cooling elements is to
allow it to transition from the temperature of the freezer to a
temperature proximal to the desired phase change temperature. This
can be achieved simply by exposing the cooling elements to the
ambient room temperature by placing it out on a counter (not in the
insulated case), for approximately 30 to 60 minutes.
[0018] The container can include an inner caddy, which provides for
a bottom portion connected to sidewalls, a front wall, a back wall
and a middle divider. Lifting means can be provided for lifting and
removing the inner caddy from the container. Lifting means may
include a handle, strap, tab, or anything that can be grasped or is
generally known and used by those skilled in the arts. In one
arrangement, the walls include one or more top portions that are
hinged. The top portions may form a lid which opens outwardly from
the receptacle area. In another arrangement, the inner caddy opens
from front to back providing access to its contents. The inner
caddy is removable with cleaning vents, allowing for self-drainage
and ease of cleaning. The inner caddy is conveniently sized such
that it may be stored in a standard or commercial refrigerator with
the item to be transported preloaded in the caddy until the item is
ready for transport or use.
[0019] The container can be further equipped with a receiving area
for a temperature data-logging device which comprises of at least
one probe for monitoring, collecting and reporting data concerning
the item being transported. Suitable temperature data-logging
devices may include for example a Validator, which consists of
proprietary technology currently available through American Thermal
Wizard International, Inc. The temperature data-logging device is
programmable to meet the compliance requirements and will
continuously monitor the temperature of the item while it is housed
in the container. The information once logged can be graphed or
logged and is capable of being downloaded into Microsoft Word.RTM.
or Excel.RTM.. The temperature data-logging device can be
programmed to either transmit an alarm or a page if the temperature
range falls or exceeds the set parameters.
[0020] The container can be further equipped with a GPS device
and/or a cell phone or any other suitable position logging and/or
communications devices so that the position of the container can be
tracked, and optionally reported to a user in real time.
[0021] In another arrangement of the invention, a container for
transporting temperature controlled items includes an outer case
including a lid, an insulating layer substantially inside the outer
case and the lid, and a removable cooling element capable of
maintaining temperature within a prescribed temperature range for
predetermined periods of time upon being kept at a predetermined
temperature prior to use. The cooling element is shaped so as to
define a receptacle area therein, into which at least one item for
transportation may be placed such that the item for transportation
is substantially surrounded by the cooling element.
[0022] The cooling element includes a bottom, side walls and at
least one lid portion, the at least one lid portion being hingedly
attached to at least one side wall to allow access to the
receptacle area defined within the cooling element. The cooling
element can include phase change material disposed therein. The
phase change material can be sealed within the cooling element. In
one arrangement, the cooling element at least partially comprises
an ABS plastic.
[0023] In yet a further arrangement, the invention relates to a
method of transporting temperature controlled items, the method
including supplying a container having an outer case including a
lid; an insulating layer substantially inside the outer case and
the lid; at least one removable cooling element capable of
maintaining temperature within a prescribed temperature range for
predetermined periods of time, the at least one removable cooling
element being disposed within the outer case and at least partially
defining a receptacle area; and a caddy located in the receptacle
area and designed to accommodate at least one item, with the caddy
at least partially surrounded by the at least one cooling element.
The method further includes removing the at least one removable
cooling element from the container, cooling the at least one
removable cooling element for a predetermined period of time in a
freezer, refrigerator or other temperature controlled environment,
and replacing the at least one removable cooling element in the
container. The item to be transported is placed into the caddy, and
the caddy is placed into the receptacle area, at least partially
surrounded by the at least one cooling element. The container is
closed so as to substantially surround the at least one cooling
element by the insulating layer; and the temperature controlled
items are transported.
[0024] The at least one removable cooling element can be frozen for
at least 24 hours prior to replacement in the container for use.
The at least one removable cooling element can be conditioned after
cooling and prior to replacement in the container for use, by
placing the cooling element at room temperature for approximately
30 minutes.
[0025] Preferably, the at least one cooling element comprises
cooling material sealed therein, the cooling material comprising a
phase change material.
[0026] The method can also include the step of monitoring at least
one of temperature within the caddy and location of the container
during transportation of the container.
[0027] For a further and more fully detailed understanding of the
present invention, various objects and advantages thereof,
reference is made to the following detailed description and the
accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0028] Further objectives and advantages of the invention will
become more apparent from the following description and claims and
from the accompanying drawings herein.
[0029] FIG. 1 depicts a container for transporting temperature
controlled items according to the present invention.
[0030] FIG. 2 depicts an external view of one arrangement of the
container for transporting temperature controlled items.
[0031] FIG. 3 depicts an alternate arrangement of the container for
transporting temperature controlled items.
[0032] FIGS. 4a and 4b depict arrangements of the cooling elements
of the invention.
[0033] FIGS. 5a and 5b depicts arrangements of the inner caddy.
[0034] FIG. 6 depicts an alternate arrangement of the container
according to the invention for transporting vials of specimens.
[0035] FIGS. 7a and 7b depict alternate arrangements of the
container according to the invention.
[0036] FIG. 8 depicts an alternate arrangement of the container
according to the invention.
[0037] FIG. 9 depicts an alternate arrangement of the container
according to the invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0038] The term "temperature controlled item" is intended to cover
any product that must be kept within predetermined temperature
ranges during transport and is not intended to be interpreted in a
narrow or limiting manner.
[0039] By reference to the exemplary drawings in detail wherein
like numerals indicate like elements throughout the various views,
there is shown in FIG. 1 an exemplary container 10 for transporting
temperature controlled items in accordance with the invention.
[0040] The container 10 can include an outer case 11 that may be
formed from soft, flexible, lightweight material such as ballistic
nylon, vinyl or canvas, or a hard rigid material for more
durability, or any other suitable materials generally known and
used by persons skilled in the art. The outer case 11 is preferably
made of waterproof, stain resistant, rustproof material, which can
be easily cleaned. The container 10 may be made in different sizes
depending on the number of blood or blood product units that are
being transported. In one arrangement, the container 10 can hold
1-2 units of blood or blood products. In another arrangement, the
container 10 can hold 1-4 units of blood. Alternatively, the
container 10 can hold 1-6, or more units of blood or blood
products. Container 10 can also be modified to hold two bags of
stem cells or bone marrow by removing the vertical divider, and
only using one horizontal divider. Container 10 can also be
modified to hold a caddy rack of serum specimens in transfer
tubes.
[0041] In the arrangement illustrated in FIGS. 1-2, the outer case
11 comprises a base 12 which may be formed from a reinforced or
stiff material, or of other suitable materials generally known and
used by persons skilled in the art. In an alternate arrangement,
illustrated in FIG. 3, the base 12 may include a rigid base insert
covered with a flexible material. In the exemplary arrangement
shown, the outer flexible material is ballistic nylon, but any
suitable material may be employed. The outer case 11 further
comprises ends 14 and 14' that are connected to the base 12, with
sides 15 and 15' (not shown) extending between the ends 14 and
14'.
[0042] The container 10 provides for a lid 17, which can be
hingedly attached to the side 15 or 15' (not shown) of the outer
case 11 and may be closeable by twist latches 30, 30'. Preferably,
at least one twist latch 30 is lockable. Alternatively, other
suitable forms of closeable means such as hooks, loops, snap
fasteners, buttons, Velcro or zippers may be employed to close the
lid 17.
[0043] FIG. 3 depicts one arrangement of the invention wherein the
lid 17 is hingedly attached to one of the sides 15, and may be
closable with at least one zipper 29 and 29'. Alternatively, the
zipper 29 may extend around the entire periphery of the lid 17 such
that the lid 17 is completely removable. In another arrangement of
the invention, the lid 17 may have a zipper 29 extending around two
ends 14, 14' and one (1) side 15 so that the lid 17 may be hinged
at its attached side 15 providing maximum opening without being
completely removable. However, it will be appreciated by those
skilled in the art that any form of a lid 17 may be employed.
[0044] In one arrangement, the lid's interior 13 comprises a closed
cell PE foam insert that acts as insulation to prevent the
transmittal of external heat, thus protecting the interior contents
of the container 10. It will be appreciated that any suitable
insulating material may be used in the lid's interior 13. The
insulating material 13 may also act as a water barrier to protect
the interior contents of the container 10. In another arrangement,
a cooling module may be added to the lid's interior 13 in which
coolant material may be disposed, further enhancing the performance
of the container 11.
[0045] As shown in FIG. 2, a wheel assembly 16, 16' and anchor
screws 18, 18', 18'' located on one of the opposing ends 14 can
provide stabilizing means for the container 10 when stood on its
end 14. The stabilizing means allow the container 10 to be placed
flat on its base 12 without the container 10 tipping over. Other
stabilizing means may include at least a foot, claw or any other
stabilizing means that is generally known and used by persons
skilled in the art. In one arrangement of the invention, a
telescopic handle 19 may be provided adjacent to the base 12 for
pulling the container 10 on the wheel assembly 16, 16'. The
telescopic handle 19 is capable of gradually extending to the
desired height from the top end 14' of the container 10 when a push
button 20 is pressed. The push button 20 also serves to retract the
telescopic handle 19 when pressed.
[0046] The container 10 also preferably comprises of at least one
pair of non-retractable handles 30 and 30' (not shown) providing
alternate means for picking up and carrying the container 10. As
shown in FIGS. 1 & 2, the outer case 11 provides rings 31 and
31' (not shown) for a shoulder strap 32 (not shown) to be attached
for alternate means for picking up and carrying the container 10.
FIG. 3 shows one arrangement of the invention where the shoulder
straps are attached to the outer case 11. In certain arrangements
of the invention, an additional reinforced handle can be attached
to the top of the lid's exterior 22 providing yet another means for
picking up and carrying the container.
[0047] As shown in FIG. 1, the outer case 11 may include at least
one identification sleeve 21 which is adapted to secure and hold
documentation concerning the item or items being transported. For
example, in the case of the transportation of blood or blood
products, the documentation may include information such as a
patient's name, social security or identification number,
physician, blood type, date the blood or blood product left the
blood bank, scheduled date of delivery, number of units of blood or
blood product being transported, delivery destination, etc. The
identification sleeve 21' can be made of a clear or transparent
plastic with an opening 24 adapted with a finger notch 25 for easy
insertion and removal of documentation.
[0048] As shown in FIG. 2, in one arrangement of the invention the
outer case 11 can have more than one identification sleeve 21, 21',
one on the side 15 of the outer case 11, and the other on the lid's
exterior 22. It is understood by those practicing the art that
there can be as many identification sleeves 21, 21' as desired. As
shown in FIG. 2, the identification sleeve 21 may be secured to the
side of the container 10 by anchor screws 27, 27', 27'', 27'', or
any other securing means that are generally known and used by those
skilled in the pertinent arts, including but not limited to,
screws, nails, bolts, paste, glue and Velcro. The lid's exterior 11
is adapted for provision of any desired logo or other
identification marks or notations.
[0049] The outer case 11 can be adapted to form a receptacle area
for an insulating layer 37 made of suitable insulation materials to
shield the interior contents of the container 10 from external
temperature. Suitable insulation materials may include a
substantially rigid insulating material having a relatively low
thermal conductivity and being relatively light weight, for example
Minicel.RTM., Volara.RTM., Neoprene, Polystyrene (Styrene),
Polyethylene, VIP (Vacuum Insulation Panel), ABS and
Coroplast.RTM., TempShield.TM. and SPACE AGE.RTM.. Preferably the
insulating layer 37 is formed from rigid polyurethane.
Alternatively, the insulating layer 37 may be formed from closed
cell PE foam, and may be formed of the same material as the lid's
interior 13.
[0050] The insulating layer 37 includes a bottom portion 38 (not
shown) connected to walls 39 substantially surrounding the inner
perimeter of the outer case 11. The insulated layer 37 has a
predetermined height to substantially engage or abut the top of the
container 10 while substantially minimize the air space remaining
above the container 10.
[0051] The container 10 can also include a substantially rigid
waterproof open well 40, which may comprise PE plastic shaped to
form a receptacle area 41 for cooling elements 46, 46', 47, 47'.
The formed well 40 can substantially surrounds the insulated layer
37 and can include a bottom portion 43 connected to walls 44 in a
seamless well for spill proofing and to receive the cooling
elements 46. After the insulating layer 37 is placed in the outer
case 11, the well 40 can be inserted in the outer case 11 to
substantially engage the walls 39 and bottom portion so as to
substantially seal the insulated layer 37 to the outer case 11. In
one arrangement of the invention, the well 40 is secured to the
outer case 11 by anchor screws 45. It is understood by those
skilled in the art that other securing means such as nails, glue,
nuts and bolts may be applied to secure the well 40 to the outer
case 11, or that the well 40 may be removable from the outer case
11 for easy cleaning.
[0052] FIG. 4a depicts an arrangement of the cooling elements of
the present invention, which is responsible for keeping the inner
caddy 50 (illustrated in FIG. 5) at the required temperatures of
1.degree. C. to 6.degree. C. The cooling element 45 can be formed
of separate components 46, 46', 47, 47' that are made from strong,
durable and lightweight material and comprise at least four modular
units with refrigerant material disposed within each modular unit.
The cooling elements 46, 46', 47, 47' can include two sides 46 and
46' and a top 47 and bottom 47'. The two sides 46 and 46' can be
sized and shaped to securely fit the interior sides of the
insulation deck 40, while the top 47 and bottom 47' are sized and
shaped to fit the bottom and top of the well 40.
[0053] In another arrangement of cooling element 45, illustrated in
FIG. 4b, the cooling element 45 is formed so as to define a
receptacle 48 therein, with two hinged top portions 47 attached to
side walls 46. The cooling element 45 may also include handles 49
and may be sized to fit within the well 40. The handles 49 enable
the cooling element 45 to be easily placed into and out of the well
40. In a further arrangement of cooling element, the top portion 47
may be hinged along a long side thereof. The hinge may be formed of
Lucite, fabric, or any other suitable material. The cooling element
45 in the arrangement shown is generally rectangular in form, as is
the receptacle area 48. The walls of the cooling element 45 are
relatively rigid so that it retains its shape through numerous
cycles of freezing and thawing the phase change materials or other
cooling materials disposed within the walls of cooling element 45.
This enables several cooling elements 45 to be conveniently stacked
in a freezer prior to use, thus ensuring ease of use.
[0054] The cooling element may be formed of a single material that
retains its temperature for a prolonged period of time, or may be
formed from a combination of materials. In one arrangement,
-1.degree. C. phase change coolant packs may be embedded in
insulating material, such as Coroplast.RTM. or ABS/Starboard
plastic (Styrene). One or more 0.degree. C. phase change coolant
packs may also be used, although such coolant packs do not maintain
the desired temperature as long as the -1.degree. C. phase change
coolant packs. The phase change coolant packs may be completely
sealed within the insulating material, or may be placed in suitable
hollows created within the insulating material. When ABS plastic is
used, a solvent may be employed to melt and fuse the plastic around
the gel pack in order to prevent leakage thereof. By encasing the
gel packs in relatively rigid plastic, the gel packs can be
prevented from bulging due to their contents shifting during
thawing and refreezing, which can otherwise encroach on the
available storage space for the caddy 50. The cooling element 45
may have two phase change coolant packs located in both the top and
bottom of the element, and one coolant pack in each side. The phase
change materials are preferably gels that may be formed of any
suitable material, such as carboxymethylcellulose, ethylene glycol,
paraffins such as octadecane, n-dodecane, n-undecane, phenols,
salts (especially salt hydrides), fatty acids, esters, glycols,
starches, alcohols, and acetones and aqueous and non-aqueous
combinations thereof. It will be appreciated that cooling materials
other than phase change gels may be employed, such as paraffin
packs, paraffinic and naphthenic oils and oil mixtures, and
aromatic hydrocarbon compounds. Synthetic oils, such as polyalpha
olefins, polyalkylene glycols and polyalkylene glycol ethers,
dialkyl ethers, acetals, and derivatives thereof may also be
used.
[0055] To use the cooling element 45, the element can be frozen in
a commercial or home freezer at temperatures set at or below
-10.degree. C. for at least 24 hours, and then conditioned (allowed
to stand at room temperature for 30-60 minutes after removal from
the freezer) prior to use. If the cooling element 45 is already
partially frozen, twelve (12) hours of freezing should prove
sufficient. The cooling elements 45 are stackable and easily stored
in the freezer. After each use, the cooling element 45 can be
removed from the container 10 and refrozen before each day's use.
Once the cooling element 45 is frozen and conditioned, it may be
inserted into the container 10. In the case of separate components,
the bottom 47' can be first placed in the bottom of the well 40 and
the sides 46 and 46' can be inserted along the sidewall of the well
40 forming a receptacle area 48 for the inner caddy 50. After the
inner caddy 50 is loaded and properly secured within the receptacle
area 48, the top 47 can be placed on top of the inner caddy 50. In
the case of a single cooling element 45, the cooling element can be
placed in the well 40 by means of the handles 49, and the hinged
top portions 47 can be opened ready to receive the inner caddy
50.
[0056] In certain situations, a standby cooling element (not shown)
may be employed. The standby cooling element may be sized and
shaped to fit within the receptacle area 48 of the cooling element
45. The standby cooling element may be frozen along with the
cooling element 45, and may be inserted into the receptacle area 48
prior to use. Such an arrangement can be useful if the container 10
is transported empty to pick up an item to be transported, or can
be useful if the container 10 is stored ready to be used for
emergency use, such as on an ambulance, helicopter, airplane or
other emergency vehicle. The standby cooling element can help to
retain the receptacle area 48 at the desired temperature for as
long a time period as possible. The standby cooling element is
removed from the container 10 prior to insertion of the caddy 50
and the item(s) to be transported.
[0057] FIGS. 5a and 5b depict arrangements of the inner caddy 50
made to hold, transport and monitor the temperature of 1 to 6 units
of blood or blood products at the required temperature range.
Typically, one arrangement of the caddy may be sized to receive
both 450 cc sized whole blood units, and 350 cc PRBC blood product
units. It will be appreciated by those of skill in the art that
different caddies may be sized differently for different payloads,
as typically food, chemicals, pharmaceuticals, biologics,
laboratory specimens, stem cells, bone marrow and organs are
transported in different sized containers. The appropriately sized
caddy can be selected for the item being transported. For example,
different caddies to transport 2-6 units of blood, 2-3 units of
stem cells or 1-2 units of bone marrow may be sized with the same
external dimensions to fit inside a container 10. In this way, it
is not necessary to carry a large stock of different sized
containers 10 because the inner caddy 50 can be swapped out
depending on the particular transport application. Additionally, in
certain arrangements, the use of a caddy is not necessary, as the
item to be transported may be placed directly into the receptacle
area defined by the cooling elements.
[0058] The inner caddy 50 is preferably constructed of clear,
durable and lightweight material, such as Lucite or polycarbonate
material or other like materials that are generally known and used
by those skilled in the arts. However, it is understood that any
material of like properties that is known and generally used by
those skilled in the arts may be employed. The inner caddy 50 is
removable and has cleaning vents 57, allowing for self-drainage and
easy cleaning. The inner caddy 50 comprises of a bottom portion 58
connected to walls 59.
[0059] Preferably, the inner caddy 50 defines a holding area 60
that can accommodate two or more items, such as units of blood or
blood products or other biological material, vials of
pharmaceuticals and the like, etc, for transportation at the
required temperature range. As best seen in FIG. 5b, holding area
60 is defined by sidewalls 80, front wall 81 a back wall 82, and a
middle divider 83. To store a unit of blood or blood products in
the holding area 60, the unit can be inserted in an upright
position in between one of the straight side walls 80 and the
middle divider 83. The sidewalls 80 and middle divider 83 can, for
example, be sized and shaped to hold and secure a unit of blood or
blood products placed between them.
[0060] In one arrangement of the invention, the holding area 60 is
adapted and sized to hold 1 to 2 units of blood products. In
another arrangement, the holding area 60 is adapted to hold up to
four units of blood or blood products. In yet another arrangement,
the holding area 60 is adapted to hold six or more units of blood
or blood products. It will be readily understood that the holding
area 60 is sized appropriately to receive and securely hold any
item that is to be transported. The sidewalls 80 can be hingedly
connected to lids 85, 85', which either extend outwardly open from
the holding area 60 to form gull wings or from front to back (not
shown). Each lid 85, 85' is situated on an opposing side of the
inner caddy 50. In one arrangement, lifting means 86 are provided
for easy removal of the inner caddy 50 from the container 10.
Lifting means may include a handle, strap, tab, or anything that
can be grasped or is generally known and used by those skilled in
the arts. In one arrangement, lids 85, 85' include an aperture 87
(not shown) adapted to receive the lifting means. The inner caddy
may be kept refrigerated with the biological material or
pharmaceutical stored therein prior to use for transportation
purposes.
[0061] In one arrangement of the invention, the lids 85, 85' can be
adapted to receive tamper resistant security tags or clips. If the
tamper resistant security tags are still in place at the
destination address for the item being transported, then the
recipient can be assured that the item was not removed from the
container 10. The tamper resistant security tags provide an
effective means of ensuring compliance with certain protocols.
[0062] As shown particularly in FIG. 5a, the inner caddy 50
provides for a receiving area 90, which is sufficiently wide and
deep enough to hold and secure a temperature data-logging device
91. In the preferred arrangement, the receiving area 90 is secured
to the front wall 81 of the inner caddy 50. However, it is
appreciated by those skilled in the arts that the receiving area 90
may be located anywhere on or near the inner caddy provided that
the temperature data-logging device 91 is proximately located near
the blood or blood units being transported for monitoring
purposes.
[0063] The temperature data-logging device 91 can comprise at least
one probe 92 for monitoring, collecting and reporting data
concerning the items being transported. The probe 92 may be
inserted into a protected channel formed in the caddy 50, proximate
to the items being transported. The temperature data-logging device
91 can be pre-programmable and can be adapted to monitor the
temperature of the items being transported for 24+hours to meet the
courier or recipient's protocols. In this manner, compliance and
performance of the invention can be documented and verified. The
temperature data-logging device 91 may include a connection point
to enable it to be connected to a computer docking station for
downloading the temperature data, or may connect with a computer
wirelessly. Typically, the temperature data is downloaded into
suitable software that can produce a graph showing the trend in
temperature recorded by the probe 92 over time. In some
arrangements, the temperature data-logging device 91 and/or the
probe 92 may be incorporated into the caddy 50.
[0064] After the cooling element 45 has been frozen, conditioned
and placed in the container 10, the inner caddy 50 is removed from
the refrigerator with the temperature controlled items to be
transported and inserted into the receptacle area 48 formed by the
cooling element 45 for receiving the inner caddy 50. The
temperature data-logging device 91 is now ready for monitoring and
can be positioned in the receiving area 90 with its probe inserted
in the holding area 60 at or near the items being transported. The
temperature data-logging device 91 may be activated by swiping it
with a start magnet, or otherwise switched on. Thereafter, the
temperature data-logging device 91 can continuously monitor the
units of biological material or pharmaceutical during the entire
time of transport for up to 24+hours. The temperature data-logging
device 91 can be programmed to either transmit an alarm or a page
if the temperature range is outside the set parameters.
Alternatively, or in addition, a user can download data from the
data-logging device 91 once the container 10 has reached its final
destination, and can view the temperature information on a computer
or can print out the information.
[0065] Instead of placing the data-logging device 91 in the caddy
50, it may alternatively be placed in a receptacle created in the
lid or side walls of the container 10, such that a display on the
data logging device 91 may be viewed without opening the container
10. In this way, the inside temperature of the container 10 as
recorded by the probe 92 may be easily checked during
transportation of the items without compromising the integrity of
the interior of the container 10.
[0066] The container 10 may also be equipped with a cell phone/GPS
unit such that a user can call the cell phone in order to find out
the location, speed of travel, temperature, etc of the unit. It
will be appreciated that any suitable communications device may be
used, and that a cell phone is used as an example only. For
example, an email alert may be transmitted by a wireless
communications device such as a Blackberry.TM.. Additionally, any
suitable location detecting system may be employed, not limited to
GPS systems. For example, in an alternative arrangement, the
container 10 may be fitted with an RFID tag, which may be read by
sensors located at various points in its journey (or the container
10 may be fitted with a sensor capable of reading static RFID tags
located at various points). This arrangement may be useful when
used in combination with a courier or delivery company that has
RFID tracking equipment at its warehouses and other locations along
a delivery route. Yet a further alternative location tracking
system can involve barcode labels provided on the outside of the
container 10 that can be scanned as the container 10 is transported
along a delivery route.
[0067] It is possible to program geographical parameters outside
which the container 10 should not travel, and have the cell
phone/GPS unit or other location tracking system call or page a
user if the container 10 is found to be outside this area. This
arrangement can help to alleviate routing errors in transportation
which cause the item to be in transit for longer than is desirable.
The cell phone/GPS unit or other communications/tracking system may
be incorporated into the temperature data-logging device 91, or may
be separate therefrom. Preferably, the temperature data-logging
device 91 sends temperature data to the cell phone/GPS unit so that
the temperature information may be transmitted by the cell phone to
a user. Preferably, the communication between the data-logging
device 91 and the cell phone is carried out wirelessly. The antenna
for the cell phone/GPS unit functions optimally when the exterior
of the case 11 is formed of ballistic nylon or other suitable
material that does not interfere with reception. Batteries for the
cell phone/GPS unit are also included. Additionally, sensors may be
included for monitoring opening of the container 10, and/or the
caddy 50. A processor may be included.
[0068] An alarm system may be included, such that an alarm may
sound at any point that the temperature recorded by the
data-logging device 91 is outside the required range. The alarm
system may include an audible alarm that may be heard by a person
transporting the container 10, or may be connected to a
communications device so that a user may be alerted by call, page,
email or any other type of communications that the item being
transported has been compromised. Steps may then be taken to
immediately rectify the temperature of the item, such as by
checking that the container 10 has not been opened, or to
immediately send replacement items to the intended recipient of the
items.
[0069] Another arrangement of the invention is illustrated in FIG.
6 for transporting test tubes and vials of specimens. The container
100 of FIG. 6 may be smaller than the containers of FIGS. 1-5,
because it may be sized to receive tubes or vials of specimens
rather than bags of blood or blood products or other biological
materials. The container 100 in FIG. 6 may comprise an outer layer
102 which may be formed material, a layer of phase change coolant
(number not shown) that goes between 102 and 104, an inner layer
104 of formed plastic or non-reactive material that is attached to
lid 108 so that any leakage of the coolant material will not react
with the 102, 104, and 106. It is also preferred that all the
components are sealed together. A cap 112 also can be included. The
entire container 100 may be frozen for 24 hours prior to use. The
test tubes or vials to be transported may be wrapped in a plastic,
polyethylene or other suitable bag, or in bubble wrap, and are
placed within the inner caddy 110.
[0070] A further arrangement of the invention is illustrated in
FIG. 7a. In this arrangement, the container 120 comprises an outer
corrugated layer 122, a large flexible bag 124, which may be formed
of Mylar or any suitable material, an insulating layer 126 of open
cell or closed cell foam, or any other suitable material, a second
smaller Mylar or other flexible bag 128, and container 100. The
Mylar or other foil bags provide air barriers to aid with
insulation. The bags 124 and 128 may be open at the top, and may be
simply closed in an overlapping manner using a gift wrap type fold,
meaning that a user does not need to use glue or tape to keep the
bags closed. The insulating layer 126 may be formed as several
separate pieces to surround the inner container 100, or may include
fewer pieces that are folded or otherwise joined. Preferably at
least the top of the insulating layer is removable from or hingedly
attached to the walls so that access to the interior of the
container 120 may be easily gained. Container 100 is frozen prior
to use, preferably for at least 24 hours. The container 100 can
transport products for a minimum of 24-48 hours at the required
temperature. Larger container 100 may be employed to transport
larger volumes of specimens, foods, pharmaceuticals, and items that
are bulkier than, for example, blood and blood products and other
biological materials. Container 100 can also be used by itself to
hold specimens at compliance temperature inside outer type
containers such as laboratory specimen lock boxes used at physician
offices for holding laboratory specimens awaiting courier
pick-up.
[0071] A further arrangement of the invention is illustrated in
FIG. 7b. In this arrangement, the container 120 comprises an outer
corrugated layer 122, a large flexible bag 124, which may be formed
of Mylar or any suitable material, an insulating layer 126 of open
cell or closed cell foam, or any other suitable material, a second
smaller Mylar or other flexible bag 128, and several phase change
material packs 130. The Mylar or other foil bags provide air
barriers to aid with insulation of the gel packs 130. The bags 124
and 128 may be open at the top, and may be simply closed in an
overlapping manner using a gift wrap type fold, meaning that a user
does not need to use glue or tape to keep the bags closed. The
insulating layer 126 may be formed as six separate pieces to
surround the inner compartment, or may include fewer pieces that
are folded or otherwise joined. Preferably at least the top of the
insulating layer is removable from or hingedly attached to the
walls so that access to the interior of the container 120 may be
easily gained.
[0072] In the illustrated arrangement, six -1.degree. C. coolant
packs 130 are employed, and the gel packs 130 may have different
sizes such that 2 larger packs may go on the top and bottom of a
specimen to be transported, with 4 smaller packs around the sides
of the specimen. The 4 smaller packs may be connected together to
form a single wall that may be folded easily at the joins between
the packs. Different phase change coolant packs 130 may be switched
in and out of the container 120, depending on the type of specimen
that is to be transported. For example, -18.degree. C. to
-25.degree. C. phase change coolant, -50.degree. C. phase change
coolant if ultra-low freezers are available, or +2.degree. C. to
+5.degree. C. phase change coolant may be used, depending on the
temperature at which the product is to be transported. The coolant
packs are frozen prior to use, preferably for at least 24 hours,
and the product to be transported is surrounded by the coolant
frozen packs. Alternatively, phase change coolant packs
incorporated into cooling elements 45 may be used, with the cooling
elements sized depending on the product that is to be transported.
The product to be transported may be placed directly inside the
compartment created by the coolant packs 130, or may be placed
inside a material such as bubble wrap prior to being placed inside
the container 120, in order to prevent any cold spots forming in
the product in any location where the product may directly touch
the coolant packs 130. The container 120 can transport products for
a minimum of 48-96 hours at the required temperature. Larger
containers 120 may be employed to transport pallets of products,
for example for military or laboratory use, or for the
transportation of food, chemicals or other bulky items. The
container 100 of FIG. 6 may be used within the container 120 to
provide additional temperature stability to the container 100.
[0073] In another arrangement of the invention, illustrated in FIG.
8, different temperature zones may be created within the same
container 140 for the transport of different products at the same
time. For example, three different temperature zones such as
ambient, refrigerated and frozen may be included. In order to do
this, removable insulating dividers 141 may be arranged to create
different temperature zones. In the illustrated arrangement, two
dividers 141 can create three temperature zones. The dividers 141
may be used inside a rigid insert well 142, and an insulating layer
143 may be provided on the interior of the lid 144 of the container
140. The container 140 may have an outside document window 145 and
pocket 146, and may have wheels (not shown) and an extendible
handle 148 to enable transport of the container. Additional handles
149 may also be provided. The exterior of the container 140 may be
of any suitable material, such as ballistic nylon, and the
insulating layers (not shown) in the wall of the container 140, as
well as the insulating layer 143, may be formed of closed cell foam
or any other suitable insulation. A phase change cooling element
(not shown) and optionally a caddy (not shown) can be used in each
temperature zone created by the insulating dividers 141 to maintain
required temperatures in the three different temperature zones. It
will be appreciated that the number and size of the temperature
zones may be varied by using different configurations of dividers
141, depending on the application. The temperature zones may be
used to control the length of time that the container 140 may be
used, such that the container 140 may be used for 12, 24, 48 or 72
hours depending on the initial temperature of the phase change
coolant packs.
[0074] A further arrangement of the invention is illustrated in
FIG. 9. In this arrangement, the container 150 may be sized to take
up a half pallet (for example, having outside dimensions of 27''
high, 26.5'' wide and 22.5'' deep). Alternatively, the container
150 may be sized to take up a whole pallet, or any other suitable
size. An advantage of sizing the container to take up a half or
whole pallet, is that the container 150 may be easily transported
using commercial shipping companies, and may be particularly
suitable for bulk deliveries, such as for food, medicines, vaccines
and the like. The container includes an internal insulating layer
152 of PE foam, which may for example, be 3'' thick. A removable
insert well 154 formed of a strong, durable material may have
handles 156 so that the well and its contents may be easily lifted
out of the container 150. The cooling element 158 may be formed of
any suitable material, such as ABS plastic with phase change
material sealed therein. The cooling element 158 may have walls
that are 2'' thick, with an interior payload space 160 of
14''.times.10''.times.15''. It will be appreciated that the sizes
given herein are exemplary only, and that the invention is not
intended to be limited in this regard. The cooling element 158 can
be formed as a rectangular box 162, with a hinged lid 164 allowing
access to the interior thereof. Alternatively the cooling element
158 may have a removable, unhinged lid. The container 150 may be
equipped with a cellphone/GPS unit and/or a temperature logging
device as in other arrangements.
[0075] All the arrangements of the invention result in lightweight,
reusable shipping containers for temperature controlled items and
which keep the temperature of the items within predetermined ranges
during transportation. Monitoring of the temperature may be used
with any of the arrangements, by using a temperature data-logging
device 91 inside any of the containers.
[0076] All arrangements of the invention allow for complete
cold-chain transportation solutions. It is possible, for example,
to pool ownership of the containers and cooling elements so that
delivery companies are able to lease containers and cooling
elements separately. This would enable a delivery company to keep
cooling elements pre-frozen at various points in the delivery
route, and to change the cooling elements if necessary prior to
final delivery of the item. For example, in some applications it
may be desirable to change the cooling element every 12 or 24
hours.
[0077] Further modifications and alternative arrangements of
various aspects of the invention will be apparent to those skilled
in the art in view of this description. Accordingly, this
description is to be construed as illustrative only and is for the
purpose of teaching those skilled in the art the general manner of
carrying out the invention. It is to be understood that the forms
of the invention shown and described herein are to be taken as the
presently preferred arrangements. Elements and materials may be
substituted for those illustrated and described herein, parts and
processes may be reversed, and certain features of the invention
may be utilized independently, all as would be apparent to one
skilled in the art after having the benefit of this description of
the invention. Changes may be made in the elements and compositions
described herein or in the features or in the sequence of features
of the methods described herein without departing from the spirit
and scope of the invention as described in the following
claims.
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