U.S. patent application number 15/066594 was filed with the patent office on 2016-11-24 for constant-temperature transportation method.
The applicant listed for this patent is Panasonic Intellectual Property Management Co., Ltd.. Invention is credited to AKIRA ISOMI, HIDEKI YAMASHITA.
Application Number | 20160341455 15/066594 |
Document ID | / |
Family ID | 57324733 |
Filed Date | 2016-11-24 |
United States Patent
Application |
20160341455 |
Kind Code |
A1 |
YAMASHITA; HIDEKI ; et
al. |
November 24, 2016 |
CONSTANT-TEMPERATURE TRANSPORTATION METHOD
Abstract
A transport object is sealed in a sterilized sealed bag
including a volume adjuster, the volume of which is changed
according to a temperature change. The sealed bag is placed into a
metal sealed container. The sealed container is placed into a
temperature-controlled metal soaking container. In a state where
the soaking container is fixed to the inside of an insulated
container with an insulation material disposed around the soaking
container, the internal pressure of the sealed container is
maintained at a constant atmospheric pressure by changing the state
of a pressure adjustment valve from a closed state to an open
state, the pressure adjustment valve being provided in an air
ventilation tube which is disposed to extend to the outside of the
soaking container and the insulated container from the sealed
container. Subsequently, after the internal temperature of the
sealed container reaches a predetermined temperature, the pressure
adjustment valve is closed again, and then, the insulated container
is transported.
Inventors: |
YAMASHITA; HIDEKI; (Osaka,
JP) ; ISOMI; AKIRA; (Osaka, JP) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Panasonic Intellectual Property Management Co., Ltd. |
Osaka |
|
JP |
|
|
Family ID: |
57324733 |
Appl. No.: |
15/066594 |
Filed: |
March 10, 2016 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
F25B 21/04 20130101 |
International
Class: |
F25B 21/04 20060101
F25B021/04 |
Foreign Application Data
Date |
Code |
Application Number |
May 20, 2015 |
JP |
2015-102841 |
Claims
1. A constant-temperature transportation method, wherein a
transport object, which is a temperature-control target object, is
sealed in a sterilized sealed bag including a volume adjuster, the
volume of which is changed according to a temperature change, the
sealed bag is placed into a metal sealed container, the sealed
container is placed into a temperature-controlled metal soaking
container, and in a state where the soaking container is fixed to
the inside of an insulated container with an insulation material
disposed around the soaking container, the internal pressure of the
sealed container is maintained at a constant atmospheric pressure
by changing the state of a pressure adjustment valve from a closed
state to an open state, the pressure adjustment valve being
provided in an air ventilation tube extending to the sealed
container via the soaking container and the insulated container ,
and wherein, subsequently, after the internal temperature of the
sealed container reaches a predetermined temperature, the pressure
adjustment valve is closed again, and then, the insulated container
is transported.
2. The constant-temperature transportation method of claim 1,
wherein the internal pressure of the sealed container is maintained
at a constant atmospheric pressure by changing the state of the
pressure adjustment valve from a closed state to an open state when
the sealed container is removed from the soaking container.
3. The constant-temperature transportation method of claim 1,
wherein a space occupying at least 15% or more of the total volume
of the sealed bag after the transport object is set is provided as
the volume adjuster of the sealed bag, and during the
transportation of the insulated container, the volume of the space
is changed according to a change in the external pressure of the
sealed bag.
4. The constant-temperature transportation method of claim 1,
wherein during the transportation of the insulated container, the
internal temperature of the sealed container is measured by a
wireless thermometer or a thermocouple installed inside the sealed
container, and wherein temperature control is performed based on
the measured internal temperature of the sealed container such that
the temperature of the transport object before and during
transportation remains substantially constant.
5. The constant-temperature transportation method of claim 1,
wherein the soaking container includes a cooling-side thermal
conductor; a heat dissipation-side conductor; a Peltier module
interposed between the cooling-side thermal conductor and the heat
dissipation-side conductor; a power supply configured to supply
electrical power to the Peltier module; a power supply-control
temperature sensor installed in the vicinity of a portion of a
surface in contact with the cooling-side thermal conductor outside
of the soaking container, or installed in the cooling-side thermal
conductor; a temperature-display temperature sensor installed in a
portion of an external side surface of the soaking container, which
indicates a temperature approximate to the temperature of the
center inside of the soaking container; and a power supply
controller configured to control power supply to the Peltier module
based on detection results from the power supply-control
temperature sensor and the temperature-display temperature sensor,
and wherein during the transportation of the insulated container,
the power supply to the Peltier module is controlled based on the
detection result from the power supply-control temperature sensor
and the detection result from the temperature-display temperature
sensor such that the temperature of the transport object is
maintained at the temperature before transportation.
6. The constant-temperature transportation method of claim 2,
wherein a space occupying at least 15% or more of the total volume
of the sealed bag after the transport object is set is provided as
the volume adjuster of the sealed bag, and during the
transportation of the insulated container, the volume of the space
is changed according to a change in the external pressure of the
sealed bag.
7. The constant-temperature transportation method of claim 2,
wherein during the transportation of the insulated container, the
internal temperature of the sealed container is measured by a
wireless thermometer or a thermocouple installed inside the sealed
container, and wherein temperature control is performed based on
the measured internal temperature of the sealed container such that
the temperature of the transport object before and during
transportation remains substantially constant.
8. The constant-temperature transportation method of claim 2,
wherein the soaking container includes a cooling-side thermal
conductor; a heat dissipation-side conductor; a Peltier module
interposed between the cooling-side thermal conductor and the heat
dissipation-side conductor; a power supply configured to supply
electrical power to the Peltier module; a power supply-control
temperature sensor installed in the vicinity of a portion of a
surface in contact with the cooling-side thermal conductor outside
of the soaking container, or installed in the cooling-side thermal
conductor; a temperature-display temperature sensor installed in a
portion of an external side surface of the soaking container, which
indicates a temperature approximate to the temperature of the
center inside of the soaking container; and a power supply
controller configured to control power supply to the Peltier module
based on detection results from the power supply-control
temperature sensor and the temperature-display temperature sensor,
and wherein during the transportation of the insulated container,
the power supply to the Peltier module is controlled based on the
detection result from the power supply-control temperature sensor
and the detection result from the temperature-display temperature
sensor such that the temperature of the transport object is
maintained at the temperature before transportation.
9. A constant-temperature transport container comprising: a
sterilized sealed bag including a volume adjuster, the volume of
which is changed according to a temperature change, the sealed bag
configured to receive a transport object; a metal sealed container
configured to receive the sealed bag; a temperature-controlled
metal soaking container configured to receive the sealed container;
an insulated container configured so that the soaking container can
be fixed to an interior portion of the insulating container with an
insulation material disposed around the soaking container; an air
ventilation tube extending though the soaking container and the
insulated container to communicate with the sealed container; an
electromagnetic valve provided in the air ventilation tube; an
in-container pressure gauge for measuring an internal pressure of
the sealed container; an ex-container pressure gauge for measuring
an external pressure of the sealed container; and a controller
coupled to the electromagnetic valve, the in-container pressure
gauge and the ex-container pressure gauge, the controller
configured to: calculate a magnitude of pressure required to cancel
out a difference between the measured external pressure and the
measured internal pressure of the sealed container; and control
opening and closing of the electromagnetic valve to obtain the
magnitude of pressure required to cancel out the pressure
difference and thereby maintain the internal pressure of the sealed
container at a substantially constant atmospheric pressure.
10. The constant-temperature transport container of claim 9,
wherein a space occupying at least 15% or more of total volume of
the sealed bag after the transport object is set is provided as the
volume adjuster of the sealed bag, and during transportation of the
container, a volume of the space is changed according to a change
in the external pressure of the sealed bag.
11. The constant-temperature transport container of claim 9,
wherein the soaking container includes: a cooling-side thermal
conductor; a heat dissipation-side conductor; a Peltier module
interposed between the cooling-side thermal conductor and the heat
dissipation-side conductor; a power supply configured to supply
electrical power to the Peltier module; a power supply-control
temperature sensor installed in the vicinity of a portion of a
surface in contact with the cooling-side thermal conductor outside
of the soaking container, or installed in the cooling-side thermal
conductor; and a temperature-display temperature sensor installed
in a portion of an external side surface of the soaking container,
which indicates a temperature approximate to the temperature of the
center inside of the soaking container, wherein the controller is
further configured to control power supply to the Peltier module
based on detection results from the power supply-control
temperature sensor and the temperature-display temperature sensor,
and wherein during the transportation of the container, the power
supply to the Peltier module is controlled based on the detection
result from the power supply-control temperature sensor and the
detection result from the temperature-display temperature sensor
such that the temperature of the transport object is maintained at
the temperature before transportation.
Description
TECHNICAL FIELD
[0001] The technical field relates to a constant-temperature
transportation method in which a biological material containing a
regenerated tissue or the like, which is manufactured at a cell
processing center or the like, is transported while being held in a
specific culture environment such as a predetermined temperature,
humidity, and pressure.
BACKGROUND
[0002] Regenerative medicine restores the lost function of an organ
using biological material such as regenerated tissue manufactured
by culturing a small amount of cells. In the recent years,
regenerative medicine has progressed and attracted a great deal of
attention. Regenerative medicine is innovative technology which is
anticipated to be considerably effective in treating incurable
diseases in the related art. Biological material such as
regenerated tissue used in regenerative medicine is manufactured
based on good manufacturing practices (GMP) which are a standard of
manufacturing control and quality control for medicine.
Manufacturing is performed in a cell processing center (CPC)
according to a standard operating procedure (SOP) satisfying the
GMP. In Japan, the law regarding the GMP legislated by the Ministry
of Health, Labor, and Welfare is already in enforcement (Ministry
of Health, Labor, and Welfare Ordinance No. 179, Medicine
Development No. 480). Related laws have been legislated mainly by
European and U.S. organizations (for example, the Food and Drug
Administration, and the European Commission) outside of Japan.
[0003] At an early stage in putting regenerative medicine into
practical use, biological materials were assumed to be manufactured
in a small number of CPCs (that is, production bases), and shipped
to medical institutions at many locations, that is, transported and
used in treatment. Even if a medical institution, in which
treatment is performed, is located in the same site in which a cell
processing center in which manufacturing is performed is located,
the medical institution has cleanliness lower than that of the
culture environment, and a daily living space is present between
the medical institution and the cell processing center.
Accordingly, biological materials are inevitably required to be
transported various distances. In the coming years, it is assumed
that foreign countries' need for regenerative medicine will be
increased, and the possibility of transportation between foreign
countries and Japan in a state where the quality is maintained
securely and safely is increased.
[0004] Currently, biological material such as regenerated tissue is
routinely transported in the field of research and development. In
contrast, a transportation method based on a standard (standard
regarding good logistics) such as a typical good distribution
practice (GDP) set to ensure the quality in the transportation and
storage processes has not yet been established in the
pharmaceutical industry. Various transportation methods are
present, and a transportation method is appropriately selected from
these transportation methods according to the type of a cell, or
the use of the cell after being transported. Examples of the
transportation method different from each other include: a method
in which cells are transported in a state where a transportation
temperature is set to be the same as the culture temperature, and
is maintained at a constant temperature (for example, at
approximately 37.degree. C.) ; a method in which cells are
transported in ambient air in a state where temperature control is
not performed (for example, at 10.degree. C. to 37.degree. C.) ; a
method in which cells are transported in a refrigerated state in a
state where cell metabolism is suppressed (for example, at
4.degree. C.) ; and a method in which cells are transported in a
frozen state (for example, in liquid nitrogen or the like at
-20.degree. C.). Unlike the manufacturing process, the
transportation process is affected by temperature, humidity,
pressure, impact, vibration, or the like.
[0005] First, the temperature of the external environment, to which
a biological material is exposed during transportation, is
different from the temperature of the culture environment. The
temperature is appropriately selected in the culture environment of
a cell processing center according to the type or use of a cell. In
many cases, the culture temperature is 37.degree. C. Since a
constant temperature chamber is used for temperature control, the
range of a temperature change is small. In contrast, the external
environmental temperature is changed according to locations during
transportation. Accordingly, a mechanism for maintaining the
internal temperature of a cell transport container at a constant
temperature is required to eliminate an impact of the external
environmental temperature. It is necessary to ensure thermal
insulation properties by installing an insulation material or the
like around the cell transport container to reduce an impact of the
external environmental temperature. A considerable amount of time
for which the internal temperature is maintained to be constant is
desired. When a cell transport container is transported far off to
foreign countries by airplane in the future, the cell transport
container is assumed to be on standby due to the occurrence of
unexpected troubles during loading and unloading under severe
conditions in an airport's apron site or during customs
formalities, or due to inspection or the preparation of an
operation after the cell transport container is delivered to a
medical institution which is a destination of transportation.
[0006] An important requirement item is that a cell transport
container maintains the temperature of a transport object over a
long period of time. The reason for this is that a transport object
is assumed to be transported overseas in the future. It is also
assumed that a treatment is prepared in a state where a culture
container is accommodated inside a cell transport container after
being delivered to a medical institution. It is possible to
maintain the temperature over a considerable amount of time by
increasing the amount of a chemical substance or a heat storage
material used, but this leads to an increase in the total weight of
the cell transport container. As a result, a burden on transport
workers is increased. An improvement in thermal insulation
properties and heat-retaining efficiency is required to avoid the
burden.
[0007] As illustrated in FIG. 6, in the configuration disclosed in
Japanese Patent No. 5476556, a second insulated container 603 is
disposed inside a first insulated container 601 with a thermal
conductive cushioning material 602 interposed between the first
insulated container 601 and the second insulated container 603. An
air-tight container 605 is built into the second insulated
container 603 via multiple split heat-storage boxes 604 which are
disposed without gaps present in any direction to form a structure
in which insulation materials and thermal conductive members are
alternately stacked on top of each other in a duplicated manner.
Therefore, an improvement in thermal insulation properties and
heat-retaining efficiency is realized.
[0008] In contrast, pressure is another factor which is changed in
the external environment during transportation from the temperature
when cells are cultured. A normal pressure of approximately 1 atm.
is applied to a culture container in a culture environment, and
particularly when transportation is made by airplane, a pressure of
approximately 0.8 atm. is applied to the cabin. When a typical
culture container is depressurized, gas dissolved in a culture
medium is eluted, pH is changed, and thus, the culture medium is
brought into a condition not suitable for cell growth. The culture
medium may also leak out through the gap between a cover and a body
of the culture container. In this case, cleanliness is lost, and
biological contamination occurs. An air tightening mechanism to
eliminate an impact of pressure is required to avoid the loss of
cleanliness and biological contamination. Air tightening can be
realized by means such as screws or a hinge fixture. When the
volume of an air-tightening target is increased, the sizes of
necessary components are increased, and the entire weight of a cell
transport container is increased. As a result, a burden on
transport workers is increased.
[0009] In contrast, in the configuration disclosed in Japanese
Patent No. 5476556, the size of a cell accommodating container is
reduced such that the cell accommodating container can be placed
into a pass box, and safety is ensured by installing a temperature
sensor and a pressure sensor in addition to ensuring air-tightness
of the cover.
[0010] When the cell accommodating container is transported from a
cell culture facility, it is necessary to remove the cell
accommodating container from a room temperature or 37.degree. C.
environment, and to place the cell accommodating container into a
transport container, the temperature of which is controlled to a
desired temperature. At this time, a rapid temperature change is
not avoidable in any case, and the internal pressure of a sealed
container may be changed according to the temperature change.
Similarly, when the sealed container is delivered to a laboratory
or a hospital which is a destination of transportation, and then
the sealed container at a low temperature is opened, a pressure
change according to a rapid temperature increase may occur, thereby
causing damage to cells.
[0011] A constant-temperature transportation method is required to
cope with a state change caused by a change in the environment
during operations before and after transportation.
SUMMARY
[0012] As described above, in the constant-temperature
transportation method of the related art, technology for
maintaining a constant temperature is required, or it is necessary
to eliminate an impact of a pressure change when transportation is
made by airplane or the like. A cell transport container is
required to be transported into a clean culture area in a cell
processing center. Therefore, a transport container in which
technology for ensuring cleanliness is implemented has been
validated.
[0013] Cells are stored in a sealed container to prevent the
occurrence of a change in the atmospheric pressure when the cells
are transported by air. During an actual operation in which tissues
such as cells are packed in a laboratory or a hospital, and are
placed into a sealed container disposed inside a transport
container, air tightness is ensured; however, the internal pressure
of a cell containing container may be decreased according to a
temperature change when the cell tissues are removed from a cell
culture environment, and are placed into a low-temperature
transport environment, and the cells may be damaged. When the
low-temperature sealed container is opened at a laboratory or a
hospital which is a destination of transportation, a pressure
change according to a rapid temperature increase may occur, and the
cells may be damaged. Care must be taken in controlling a pressure
change in an actual operation.
[0014] In contrast, in the method of the related art, a pressure
change according to a rapid temperature change when a transport
object is placed into a transport container is not taken into
consideration. For example, in a case where a transport object is
packed in a 37.degree. C. environment, and is set into a sealed
container disposed in a transport container to keep the transport
object at 5.degree. C., due to sealability, the pressure of the
sealed container apparently becomes 897 hPa according to the gas
state equation. Similar to the case where care is taken in
controlling a change in the atmospheric pressure when
transportation is performed by air, care must be taken into damage
caused by such a pressure decrease.
[0015] Accordingly, the present disclosure concerns a
constant-temperature transportation method in which the occurrence
of a pressure change according to a change in an environment
temperature is prevented when a tissue such as a cell is packed and
placed in a sealed container disposed inside a constant-temperature
transport container.
[0016] According to an aspect, there is provided a
constant-temperature transportation method, in which a transport
object, that is, a temperature-control target object is sealed in a
sterilized sealed bag including a volume adjuster, the volume of
which is changed according to a temperature change, and the sealed
bag is placed into a metal sealed container. The sealed container
is placed into a temperature-controlled metal soaking container,
and in a state where the soaking container is fixed to the inside
of an insulated container with an insulation material disposed
around the soaking container, the internal pressure of the sealed
container is maintained at a constant atmospheric pressure by
changing the state of a pressure adjustment valve from a closed
state to an open state, the pressure adjustment valve being
provided in an air ventilation tube which is disposed to extend to
the outside of the soaking container and the insulated container
from the sealed container. Subsequently, after the internal
temperature of the sealed container reaches a predetermined
temperature, the pressure adjustment valve is closed again, and
then, the insulated container is transported.
[0017] According to the aspect, the internal pressure of the sealed
container is maintained at the constant atmospheric pressure by
changing the state of the pressure adjustment valve from an initial
closed state to an open state when placing the sealed container
containing the transport object into the soaking container, the
temperature of which is controlled to a predetermined
temperature.
[0018] After the internal temperature of the sealed container
reaches a predetermined temperature, the pressure adjustment valve
is closed again, and then, transportation is performed. Therefore,
the transport object can be transported in a state where the
constant temperature and pressure are maintained during the
transportation of the transport object. When the sealed container
is removed from the soaking container, it is possible to remove the
transport object in a state where the internal pressure of the
sealed container is maintained at the same atmospheric pressure by
changing the state of the pressure adjustment valve from a closed
state to an open state. In this configuration, the transport object
can be transported to and actually used in treatment facilities
such as a laboratory and a hospital while almost no transport
object is affected by a pressure change during an operation caused
by a rapid temperature change when the transport object is placed
into and removed from the constant-temperature transport
container.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] FIG. 1 is a partial sectional view illustrating the
configuration of a sealed container according to an embodiment.
[0020] FIG. 2 is a partial sectional view illustrating the
configuration of a sealed bag containing glass bottles in the
embodiment.
[0021] FIG. 3 is a partial sectional view illustrating the
configuration of a sealed bag containing a Schale dish in an
embodiment.
[0022] FIG. 4 is a partial sectional view illustrating the
configuration of a sealed container with an automatic opening and
closing control function according to an embodiment.
[0023] FIG. 5 is a partial sectional view illustrating the
configuration of a constant-temperature transport container
according to an embodiment.
[0024] FIG. 6 is a partial sectional view illustrating the
configuration of a cell transport container in the related art.
DESCRIPTION OF EMBODIMENTS
[0025] Hereinafter, embodiments will be described with reference to
the accompanying drawings.
[0026] FIG. 1 is a configuration view of sealed container 101 used
in a constant-temperature transportation method in an
embodiment.
[0027] In FIG. 1, transport object 90 is a temperature-control
target object, the temperature of which is required to be
controlled to a desired temperature. Transport object 90 is
disposed in metal sealed container 101 while being sealed in
sterilized sealed bag 201. Air ventilation tube 103 passes through
cover 101a of sealed container 101, and extends to the outside of
the container. Pressure adjustment valve 104 is disposed at a
distal tip of air ventilation tube 103. Pressure adjustment valve
104 serves as an example of a pressure adjuster. When transport
object 90 contained in sealed bag 201 is set in sealed container
101, and then, container body 101c is covered with metal cover
101a, press contact between container body 101c and cover 101a can
be maintained with O-ring 101b interposed therebetween.
[0028] In this configuration, a pressure change caused by a
temperature change occurring after the setting of transport object
90 can be cancelled out in sealed container 101. That is, an air
flow is allowed to flow through pressure adjustment valve 104 to
cancel out a differential pressure between the outside air pressure
and the internal pressure of sealed container 101, and to prevent
the occurrence of a pressure change in sealed container 101 by
opening pressure adjustment valve 104 in a normally closed
state.
[0029] According to the transportation method in the related art,
the temperature when transport object 90 is prepared differs from a
set temperature when sealed container 101 is transported. Due to
this temperature difference, after transport object 90 is set in
sealed container 101, the internal temperature of sealed bag 201 is
changed, and the internal pressure of sealed bag 201 is also
changed according to that change. For example, when a cell tissue,
that is, transport object 90, is set in sealed bag 201 in a
37.degree. C. environment, and then, sealed container 101 is cooled
down to 5.degree. C., internal pressure A of sealed container 101
is decreased from the atmospheric pressure to 897 hPa according to
the following gas state equation (Expression 1).
(273+37)/1000 hPa=(273+5)/A hPa
A=1000 hPa.times.278/310 (Expression 1)
[0030] In this case, the cell is highly likely to be damaged, and
thus, it is necessary to prevent the occurrence of an apparent
pressure change during such an operation.
[0031] Sealed bag 201 used in constant-temperature transport
container 80 in the embodiment will be described with reference to
FIGS. 2 and 3.
[0032] First, FIG. 2 illustrates a case in which transport object
90 is sealed in glass bottle 202. Glass bottle 202 serves as an
example of a holder for a transport object, the temperature of
which is required to be controlled.
[0033] Sealed bag 201 includes multiple glass bottles 202, each
containing a transport object (temperature-control target object),
the temperature of which is required to be controlled to a desired
temperature; and volume adjuster 203. In this case, a gap (space)
is provided as volume adjuster 203 between glass bottles 202, and
is filled with air occupying 15% or more of the total volume of
sealed bag 201. During the transportation of sealed bag 201, the
volume of the space is changed by a pressure change outside of the
sealed bag. Air ventilation hole 204 is provided in cover 202a of
glass bottle 202.
[0034] Thereafter, when sealed bag 201, in which multiple glass
bottles 202 containing transport objects 90 are set, is actually
placed inside sealed container 101 illustrated in FIG. 1, the
internal temperature of sealed bag 201 containing transport objects
90 is higher than room temperature, and approaches the internal
temperature of sealed container 101 which is set to a low
temperature. After the internal temperature of sealed container 101
reaches a predetermined temperature, pressure adjustment valve 104
is closed again. Thereafter, sealed container 101 is transported.
The internal pressure of sealed container 101 is gradually
decreased. At the same time, external air enters sealed container
101 due to the differential pressure by manually opening pressure
adjustment valve 104 in a closed state when placing transport
objects 90 inside constant-temperature transport container 80 or
removing transport objects 90 from constant-temperature transport
container 80. Therefore, the internal pressure of sealed container
101 is maintained to be constant (that is, at a constant
atmospheric pressure). The following case is assumed as the reason
the gap filled with air occupying 15% or more of the total volume
of sealed bag 201 is provided as volume adjuster 203. Since the
temperature may exceed 40.degree. C. in a high temperature
environment assumed to be encountered in a case where transport
object 90 is transported overseas by air in the future,
particularly, in Middle Eastern territories, the temperature of
transport object 90 is set to an environment temperature of
approximately 45.degree. C., and thereafter, transport object 90 is
cooled to a supercooled state at 0 degrees Celsius or less, and is
transported.
[0035] In this case, since the pressure is decreased to 85.8% of
the atmospheric pressure according to the following gas state
equation (Expression 2), a change of 14.2% in percentage is
assumed.
(273-0)/(273+45)=85.8% (Expression 2)
[0036] In a case where transportation is made in a state where a
constant temperature is also maintained in such a severe
environment, a gap filled with air occupying at least 15% of the
total volume is required to be provided as volume adjuster 203.
That is, in a case where the gap (space) filled with air occupying
at least 15% of the total volume is provided as volume adjuster
203, even if a 15% pressure change occurs during the transportation
of transport object 90, it is possible to cancel out the pressure
change, and to prevent damage to transport object 90 (for example,
a cell) by changing the volume of the space, that is, volume
adjuster 203.
[0037] It is possible to maintain a sterilized state by preventing
the flowing in and out of air through sealing portion 201a (for
example, upper end edge in FIG. 2) provided in an opening portion
of sealed bag 201, and thus, it is possible to prevent an invasion
of bacilli from an external environment.
[0038] A case in which transport object 90 is placed in Schale dish
302 together with a culture medium as illustrated in FIG. 3 is
assumed to be the same as the case in which glass bottle 202 in
FIG. 2 is used. Sealed bag 301 includes Schale dish 302 containing
transport object 90, the temperature of which is required to be
controlled to a desired temperature; and volume adjuster 303.
Schale dish 302 containing the transport object is covered with
air-breathable film 304. Since a gap is provided as volume adjuster
303 between Schale dishes 302, and is filled with air occupying 15%
of the total volume of sealed bag 301, a change in the internal
pressure of sealed container 101 caused by a temperature change can
be cancelled out by opening pressure adjustment valve 104 when
placing sealed bag 301 into sealed container 101 in a high
temperature state.
[0039] The internal pressure of sealed container 101 is maintained
at a constant atmospheric pressure by changing the state of
pressure adjustment valve 104 from a closed state to an open state,
and after the internal temperature of sealed container 101 reaches
a predetermined temperature, pressure adjustment valve 104 is
closed again. Thereafter, sealed container 101 is transported.
[0040] The opening and closing of pressure adjustment valve 104 can
be controlled not only manually but also automatically. FIG. 4
illustrates an automatic opening and closing control system. The
automatic opening and closing control system includes
electromagnetic valve 404 instead of pressure adjustment valve 104,
and further includes in-container pressure gauge 401; ex-container
pressure gauge 402; and controller 403. Although not shown, the
controller 403 can be a processor configured according to
instructions in an associated memory, or can be a dedicated chip.
As illustrated in FIG. 4, internal and external pressures of sealed
container 101 are respectively measured by in-container pressure
gauge 401 and ex-container pressure gauge 402, and measurement
information is transmitted to controller 403 in real time. At this
time, controller 403 cancels out a change in the internal pressure
of sealed container 101 by calculating the magnitude of pressure
required to cancel out the difference between the external air
pressure and the internal pressure of sealed container 101, and
controlling the opening of electromagnetic valve 404 to obtain the
magnitude of pressure required to cancel out the calculated
pressure difference.
[0041] FIG. 5 illustrates the structure of constant-temperature
transport container 80 in the embodiment when sealed container 101
is transported in a state where the temperature is actually
adjusted.
[0042] Constant-temperature transport container 80 is configured to
include soaking container 501; thermal conductive block 502;
Peltier module 503; heat sink 504; heat dissipating fan 505; vacuum
insulated material 506; power supply-control temperature sensor
507; temperature-display temperature sensor 508; power supply
controller 509; battery 510; and insulated container 511.
[0043] First, sealed container 101 is placed in soaking container
501 made of metal having good thermal conductivity. A surface of
Peltier module 503 is in contact with and is mounted to soaking
container 501 with thermal conductive block 502 interposed between
the surface of Peltier module 503 and soaking container 501. The
transferring of heat to and from Peltier module 503 is promoted via
heat sink 504 and heat dissipating fan 505 provided on the opposite
surface of Peltier module 503. Vacuum insulated material 506 is
disposed in the vicinity of soaking container 501 without gaps
between soaking container 501 and vacuum insulated material 506
such that soaking container 501 is insulated.
[0044] In this configuration, heat is dissipated to soaking
container 501 from Peltier module 503, or soaking container 501 is
heated via thermal conductive block 502 by supplying electrical
power to Peltier module 503 interposed between thermal conductive
block 502 (an example of a cooling-side thermal conductor) and heat
sink 504 (an example of heat dissipation-side conductor).
[0045] Power supply-control temperature sensor 507 is installed in
the vicinity of a portion of a surface in which thermal conductive
block 502 is in contact with Peltier module 503 outside of soaking
container 501. Power supply-control temperature sensor 507 measures
the temperature of the vicinity of the portion of thermal
conductive block 502 which is in contact with Peltier module 503.
Temperature-display temperature sensor 508 formed of a wireless
thermometer, a thermocouple, or the like is installed in a portion
of an external side surface of soaking container 501, which
indicates a temperature approximate to the temperature of the
center inside of soaking container 501. Temperature-display
temperature sensor 508 measures the temperature of the portion
indicating a temperature approximate to the temperature of the
center inside of soaking container 501. The following temperature
control is performed such that the temperature measured by
temperature-display temperature sensor 508 becomes a set
temperature (to be described later). In a temperature control
method, when a predetermined difference between detection results
from power supply-control temperature sensor 507 and
temperature-display temperature sensor 508 occurs, power supply
controller 509 controls power supply to Peltier module 503 such
that electrical power is supplied to Peltier module 503 from
battery 510 which is an example of a power supply. Basically, power
supply controller 509 is configured to control power supply to
Peltier module 503 based on the detection result from power
supply-control temperature sensor 507, and to perform control based
on the detection result from temperature-display temperature sensor
508 such that the power supply to Peltier module 503 is corrected.
Such temperature control enables the maintaining of the set
temperature set in power supply controller 509 during
transportation.
[0046] Soaking container 501, thermal conductive block 502, vacuum
insulated material 506, power supply-control temperature sensor
507, temperature-display temperature sensor 508, power supply
controller 509, and battery 510 are accommodated and fixed inside
insulated container 511 made of metal.
[0047] As an example, the set temperature can be set to any value
accurately to 0.1.degree. C. between--20.0.degree. C. and
50.0.degree. C. in power supply controller 509 of
constant-temperature transport container 80. Accordingly, when the
predetermined difference between detection results from power
supply-control temperature sensor 507 and temperature-display
temperature sensor 508 occurs, power supply controller 509 controls
power supply to Peltier module 503 such that the set temperature
can be maintained during transportation regardless of a change in
the ambient temperature.
[0048] The use of constant-temperature transport container 80
enables highly accurate secure and safe transportation of transport
object 90 without preparation of a heat storage material or a cold
insulation material being required in a state where the temperature
and pressure of transport object 90 placed inside sealed container
101 in FIG. 1 are maintained to be the same as before
transportation.
[0049] The internal pressure of sealed container 101 is maintained
at a constant atmospheric pressure by changing the state of
pressure adjustment valve 104 or electromagnetic valve 404 from a
closed state to an open state when placing sealed container 101
containing transport object 90 into soaking container 501, the
temperature of which is controlled to a predetermined temperature.
After the internal temperature of sealed container 101 reaches the
predetermined temperature, pressure adjustment valve 104 or
electromagnetic valve 404 is closed again, and then, transportation
is performed. Therefore, transport object 90 can be transported in
a state where the constant temperature and pressure are maintained
during the transportation of transport object 90.
[0050] When sealed container 101 is removed from soaking container
501, it is possible to remove transport object 90 in a state where
the internal pressure of sealed container 101 is maintained at the
same atmospheric pressure by changing the state of pressure
adjustment valve 104 or electromagnetic valve 404 from a closed
state to an open state. In this configuration, transport object 90
can be transported to and actually used in treatment facilities
such as a laboratory and a hospital while almost no transport
object 90 is affected by a pressure change during an operation
caused by a rapid temperature change when transport object 90 is
placed into and removed from constant-temperature transport
container 80.
[0051] The aforementioned various embodiments, an arbitrary
embodiment of modification examples, or the modification examples
are appropriately combined together such that effects of each of
the aforementioned embodiments, the arbitrary embodiment, and the
modification examples can be obtained. Embodiments can be combined
together, examples can be combined together, or embodiments and
examples can be combined together. The features of embodiments can
be combined together, or the features of examples can be combined
together.
[0052] A constant-temperature transport container according to the
various embodiments described above enables highly accurate secure
and safe transportation of a transport object without requiring
preparation of a heat storage material or a cold insulation
material in a state where the temperature and pressure of the
transport object are maintained to be the same as before
transportation. The constant-temperature transport container can be
applied to the transportation of cells or the like. In the future,
as need for cell sheet transplantation using Japan's regenerative
medicine technology in Japan and foreign countries increases, the
transportation of cell tissue from a donor in a constant
temperature environment will be frequently required. For example,
it is possible to easily, securely, and safely transport an
expensive transport object (for example, a cell) to a rich country
in the Middle East by using the constant-temperature transport
container of the various embodiments. Many transportation chances
are expected to occur. This may be taken as one of Japan's growth
strategies, and may lead to a large scale of business.
* * * * *