JP2004217290A - Transport vessel for cellular tissue medical device - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To transport a cellular tissue medical device including an incubated cell such as an artificial culture skin or the like easily at ambient temperature range and to transport it surely without decreasing survival rate of the cell to the utmost. <P>SOLUTION: A transport vessel for cellular tissue medical devices is composed of a double structure of an inner vessel and an outer vessel, wherein the inner vessel is provided with a function to buffer heat storing and heat transfer and the outer vessel is provided with an adiabatic function so that the vessel can be transported at ambient temperature range. <P>COPYRIGHT: (C)2004,JPO&NCIPI

Description

【００２６】
上記結果からも明らかなように実施例２では、高温、低温環境どちらの試験においても２０時間以上の満足すべき保温性能を示している。これに対し比較例では、蓄熱ゲルの効果は認められるものの、外側容器が無ければ、単独では効果として不十分であることを示している。
【００２７】
【発明の効果】
本発明は、輸送用容器を内側容器及び外側容器の二層構造から形成し、且つ内側の容器には蓄熱および熱移動を緩衝させる機能を設けると共に、外側の容器には断熱機能及び加温機能を設けることにより、室温領域での輸送が容易となり、また人工培養皮膚など培養された細胞を含む細胞組織医療用具を室温領域において細胞の生存率をできるだけ低下させることなく、確実に輸送することができるのである。
【図面の簡単な説明】
【図１】本発明における輸送用容器の概略断面図である。
【図２】本発明における加温装置の概略断面図である。
【図３】本発明による実施例２における輸送用容器の概略断面図である。
【図４】比較例１における輸送用容器の概略断面図である。
【図５】比較例２における輸送用容器の概略断面図である。
【符号の説明】
１ 輸送用容器
２ 内側容器
３ 外側容器
５ 真空断熱パネル
８ 加温装置
１２ 緩衝材
１５ 蓄熱性ゲル
１６ 商品ケース
１７ 温度測定用センサー[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention relates to a transport container capable of reliably transporting a cell tissue medical device containing animal cells within a room temperature range and without lowering the survival rate of cells.
[0002]
[Prior art]
Conventionally, when transporting a cell tissue medical device containing cells from a manufacturing factory to a medical facility where it is actually used, most of them are transported in a frozen state.
[0003]
[Problems to be solved by the invention]
Such a transportation means is a simple method, but there is a risk that the cells may be damaged and killed at the time of thawing, and in order to prevent this, extremely complicated and complicated thawing work, a skilled technique, a special device, etc. Cost.
Therefore, in the case of such frozen transportation, the above-mentioned drawbacks are compensated for by setting a large initial cell amount in advance in consideration of the decrease in viable cells.
[0004]
However, in this case, the number of cells can be secured by using allogeneic cells, but when autologous cells are returned to the patient in a short period of time, a sufficient amount of cells cannot be secured, and the number of cells less than the original number is further reduced in the thawing process. There was a problem with such a method. Furthermore, if the proper thawing operation is not carried out, the number of surviving cells is remarkably reduced, and depending on the situation at the time of use, this may be a factor that causes a change in cell activation. In addition, the transportation in the room temperature range has a drawback that transportation is limited to a short distance due to a limited heat retention time, and a large-sized apparatus having a constant temperature function or a special transportation vehicle must be used.
[0005]
[Means for Solving the Invention]
In the present invention, the transport container is formed of a two-layer structure of an inner container and an outer container, and the inner container has a function of storing heat and buffering heat transfer, and the outer container has a heat insulating function and a heating function. Is provided to facilitate transportation in a room temperature region. In addition, this makes it possible to reliably transport cultured cells such as artificially cultured skin without reducing the survival rate as much as possible.
However, the present invention has the following features.
Item 1. The transport container is formed from a two-layer structure of an inner container and an outer container, and the inner container has a function of buffering heat storage and heat transfer, and the outer container has a heat insulating function to enable transport in a room temperature region. A transport container for a medical device for cell tissue, comprising:
Item 2. Item 4. The transport container for a cell tissue medical device according to Item 1, wherein a room temperature region in the transport container is maintained within a range of 15 ° C to 35 ° C.
Item 3. Item 2. The transport container for a cell tissue medical device according to Item 1, wherein a temperature measurement sensor having a temperature recorder is provided in the transport container, and the room temperature in the container can be continuously recorded.
Item 4. Item 4. The transport container for a cell tissue medical device according to Item 1, wherein the inner container is formed of a general-purpose heat insulating material such as styrene foam or urethane foam, and the heat storage gel is stored and arranged in the inner container.
Item 5. Item 4. The transport container for a cell tissue medical device according to Item 1, wherein the outer container is formed of a general-purpose heat insulating material such as styrene foam or urethane foam and a high-performance heat insulating material such as a vacuum heat insulating panel.
Item 6. Item 2. The cell tissue medicine according to Item 1, wherein a heating device including a gas supply unit, a heating unit, and a temperature control unit is provided in the transport container, and the heating unit generates heat by a method using an oxidation catalyst. Equipment transport container.
Item 7. Item 2. The transport container for a cell tissue medical device according to Item 1, wherein the temperature recorder is stored in the outer container, and the outer container is formed as a container.
[0006]
In the present invention, the inner container and the outer container are each formed of a material having excellent heat insulating properties, and the outer container is provided with a heat insulating portion such as a vacuum heat insulating panel. The heat storage polymer contained therein was arranged as a buffer material for buffering heat transfer, so that the room temperature in the container could be kept within a predetermined temperature range as much as possible without the temperature of the transport container being affected by the surrounding external environment. The preferred temperature range for the cells to survive is in the range of 10 ° C. to 37 ° C., particularly preferably in the range of 15 ° C. to 35 ° C., so that the room temperature in the transport container is maintained within these room temperature ranges. It can be kept warm.
[0007]
Furthermore, by providing a heating mechanism inside the outer container, as necessary, as a positive heating device, which oxidizes and generates heat with a chemical catalyst to raise or maintain the temperature in the transport container, It is not necessary to equip a heavy or large device such as an external power supply or a battery. Therefore, there are advantages such as a compact and lightweight transport container, easy handling, and the like. Delivery can be easily performed by a so-called home delivery service or the like.
[0008]
In addition, it is necessary to record the product temperature in the container to ensure that the above-mentioned room temperature range is maintained during transportation, but in practice, the temperature of the product, which is a cell tissue medical device, is directly measured. Because it is difficult to perform the measurement, a temperature measuring device is provided in the inner container as a substitute index to measure the temperature in the container, and the measuring device and the temperature recorder provided in the outer container are connected by a cable. To record the room temperature continuously.
[0009]
That is, it is important to record whether or not the room temperature in the transport container is maintained within the above-mentioned room temperature range without being affected by the surrounding external environment. A device that can automatically measure and record at intervals, and that is small and lightweight is installed. In addition, by making the outer container housing the above-mentioned temperature recorder a housing type, it is possible to easily collect data of the room temperature in which the room temperature in the transport container is continuously measured, and to manage the room temperature. I try to make it convenient.
[0010]
BEST MODE FOR CARRYING OUT THE INVENTION
Embodiment 1
Hereinafter, the contents of the present invention will be described in detail with reference to the drawings.
FIG. 1 is a cross-sectional view of the transport container of the present invention when viewed from a plane. Numeral 1 denotes a transport container for a medical device for cell tissue, which has a two-layer structure of an inner container 2 and an outer container 3. Although not shown in the drawings, the inner container 2 and the outer container 3 each have a sealable upper lid connected by a hinge or the like. 5 is a vacuum heat insulating panel layer provided on the inner periphery of the outer container 3, and 7 is a heating device chamber provided inside the outer container 3. A heating device 8 and a temperature recorder 9 are housed in the same room 7, and an air intake pipe 10 is connected to the heating device 8.
[0011]
Reference numeral 12 denotes a cushioning material provided between the vacuum heat insulating panel 5 and the inner container 2, in which the inner container 2 is stored so as to prevent damage during transportation of the container. Reference numeral 15 denotes a bag-stored heat storage polymer provided inside the inner container 3, and a plastic material containing a cell tissue medical device (not shown), which is a commercial product, is further provided inside the polymer 15. A product case 16 made of glass is stored. In addition, a temperature measuring sensor 17 for detecting a temperature is provided in this portion, and this sensor is connected to a temperature recorder 9 provided in a heating device installation chamber 7 of the outer container 3 via a cable 18. The room temperature is recorded at regular intervals.
As shown in FIG. 2, the heating device 8 includes an air intake pipe 10, a gas supply unit 20 using a gas cylinder, a heating unit 21 using an oxidation catalyst, a temperature control unit 22, and a flow control valve 23. Be composed.
[0012]
The inner container 2 and the outer container 3 of the transport container 1 can be exemplified by styrene foam or urethane foam each having excellent heat insulating properties, but are not limited thereto as long as they have a heat insulating effect. In addition, as a material for forming the outer container 2 serving as a cold storage box, a general-purpose heat insulating material having excellent heat insulating properties may be used similarly to the inner container 2, but in consideration of changes in the external environment, a higher performance material is used. Things are desired. As a specific example, there is a vacuum insulation panel and the like, for example, "N's VIP" (trade name) manufactured by Nisshinbo Industries, Ltd., and the like. As an example of a cool box to which a vacuum insulation panel is applied, for example, "RYOBI Pro Target Super HEXA" (trade name) manufactured by Joshuya Co., Ltd., etc. can be mentioned.
[0013]
The heat storage polymer 15 as described above, specifically, a heat storage agent and a heat transfer buffer material are arranged around a product case 16 housed inside the inner container 2. Examples of these materials include known cold insulators and heat insulators, and heat storage agents that apply a thermal buffering action due to heat of solidification or heat of fusion can also be used. However, those which are liquefied due to a change in temperature are not preferred because heat transfer is promoted by convection.
[0014]
An example of the positive heating device 8 is a heat generation method using an oxidation catalyst. Its features are that it does not require an external power supply, it does not generate flames due to chemical heating, it is excellent in safety, and it is easy to control the amount of heat generated. is there. As a method of heat generation, external air (oxygen) is taken in by the air intake pipe 10, the flow rate of the gas is adjusted and supplied by the flow control valve 23 through the control of the temperature control unit 22, and the chemical catalyst is used. Oxidation generates heat. As a specific example, for example, "Heat Vest NQ-HV30 / LS Heating Device" (product name) manufactured by Matsushita Electric Industrial Co., Ltd. can be exemplified.
[0015]
When an active cooling device is required for the active heating device, a low-temperature transport system that has already been put into practical use in the distribution of fresh products may be used.
[0016]
In the present invention, a cell tissue (including cultured cells) medical device includes, for example, artificial skin, blood vessels, and the like, in which living cells are seeded and cultured on a base material such as collagen, a biodegradable and absorbable polymer, or a composite thereof. Materials for repairing tissues constituting a living body such as bone and cartilage can be exemplified.
[0017]
Further, in the present invention, the room temperature region refers to a temperature region in which cells are preferable to survive, and the room temperature in the present invention is preferably in the range of 10 ° C to 37 ° C, and particularly preferably in the range of 15 ° C to 30 ° C, If the temperature is higher or lower than the temperature in this range, the survival rate and proliferation rate of cells may decrease, and the performance as a cell tissue medical device may decrease, which is not preferable.
[0018]
The temperature monitoring during transportation is necessary to ensure that the above-mentioned room temperature range is always maintained, and is also necessary to record the temperature of the product in the inner container. In practice, instead of directly measuring the temperature of the product, the temperature in the inner container is measured as a substitute index. That is, even when the external environment around the transport container is extremely higher or lower than the normal room temperature, the room temperature in the transport container is not affected at all and is within the range of the room temperature. It is necessary to record whether or not it is maintained.
[0019]
Therefore, it is desirable that the temperature recorder 9 with a recorder be capable of automatically measuring and recording time and temperature at fixed intervals, and be small and lightweight. As an example of a product of such a temperature recorder 9, for example, “Data logger series TL3633” (product name) manufactured by AS ONE Corporation may be mentioned.
Next, effects of the present invention will be described together with comparative examples.
[0020]
Embodiment 2
FIG. 3 is a schematic cross-sectional view of the transport container 30 based on the first embodiment, and FIG. 3 illustrates a state in which the heating device 8 illustrated in FIG. Has a temperature measurement sensor 35 inserted in place of the commercial cell tissue medical device, 36 is a temperature measurement sensor provided in the outer container 2, and 37 is a temperature measurement sensor provided outside the transport container 30. Each of the sensors 35, 36, and 37 is provided with a temperature recorder (not shown) for recording the temperature at regular intervals. Regarding the size of the container, a plastic case made of polyacrylate having a width of 110 mm, a length of 80 mm, a height of 33 mm and a thickness of 2.5 mm was used as the product case 16, and the temperature was recorded in place of the cell tissue medical device as a product. A temperature measuring sensor 35 with a meter was inserted into the case 16.
[0021]
Next, the product case 16 in which the sensor 35 is inserted is stored as the inner container 2 in the same styrene foam container 2 having a width of 270 mm, a length of 195 mm, a height of 205 mm, and a thickness of 20 mm, and the weight is about 4.5 kg and The temperature-regulated heat storage polymers 15, 15... Were placed in the inner container 2 so as to surround the product case 16. The temperature of the heat storage polymer 15 was adjusted to 15 ° C. during the high temperature environment test and 25 ° C. during the low temperature environment test.
[0022]
Next, as the outer container 3 provided with the vacuum heat insulating panel 5, the inner container 2 containing the product case 16 and the like was stored in the container 3 having a width of 510 mm, a length of 295 mm, a height of 310 mm, and a plate thickness of 40 mm. The gap between the vacuum heat insulating panel 5 provided on the inner surface of the outer container 3 and the inner container 2 was filled with a polystyrene foam cushioning material 12 serving as a spacer, and a temperature measurement sensor 36 was inserted. The transport container 30 packed in this way is left in an environment where the temperature is adjusted to 50 ° C. during the high-temperature environment test and −5 ° C. during the low-temperature environment test, respectively, and the heat insulation performance due to the temperature change in the product case 16. Was measured. Table 1 shows the results.
[0023]
[Comparative Example 1]
FIG. 4 shows a transport container 60 based on Comparative Example 1, and in comparison with the transport container 30 of Example 1 as shown in FIG. 3, a state in which the outer container 3 with the vacuum heat insulating panel 5 is removed, ie, The transport container 60 is formed only of the product case 16 containing the temperature measurement sensor 35 and the inner container 2 containing the heat storage polymer 15, and the heat insulation performance due to the temperature change in the product case 16 is measured as in the first embodiment. did. Table 1 shows the results.
[0024]
[Comparative Example 2]
FIG. 5 shows a transport container 70 based on Comparative Example 2, in which the transport container 70 is formed only by the case 16 containing the temperature measurement sensor 35 and the inner container 2 in which the cushioning material 12 made of styrene foam is respectively stored. In the same manner as in Example 1, the heat retention performance due to the temperature change in the product case 16 was measured. Table 1 shows the results.
[0025]
[Table 1]

[0026]
As is clear from the above results, Example 2 shows satisfactory heat retention performance of 20 hours or more in both the high-temperature and low-temperature environment tests. On the other hand, the comparative example shows that although the effect of the heat storage gel is recognized, the effect alone is insufficient as the effect without the outer container.
[0027]
【The invention's effect】
According to the present invention, the transport container is formed from a two-layer structure of an inner container and an outer container, and the inner container has a function of storing heat and buffering heat transfer, and the outer container has a heat insulating function and a heating function. By providing the device, transport in the room temperature region is facilitated, and the cell tissue medical device containing cultured cells such as artificial cultured skin can be transported reliably without lowering the viability of the cells in the room temperature region as much as possible. You can.
[Brief description of the drawings]
FIG. 1 is a schematic sectional view of a shipping container according to the present invention.
FIG. 2 is a schematic sectional view of a heating device according to the present invention.
FIG. 3 is a schematic sectional view of a shipping container according to a second embodiment of the present invention.
FIG. 4 is a schematic sectional view of a shipping container in Comparative Example 1.
FIG. 5 is a schematic sectional view of a shipping container in Comparative Example 2.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Transport container 2 Inner container 3 Outer container 5 Vacuum insulated panel 8 Heating device 12 Buffer material 15 Thermal storage gel 16 Product case 17 Temperature sensor

Claims (7)

The transport container is formed from a two-layer structure of an inner container and an outer container, and the inner container has a function of buffering heat storage and heat transfer, and the outer container has a heat insulating function to enable transport in a room temperature region. A transport container for a medical device for cell tissue, comprising: The transport container for a medical device for cell tissue according to claim 1, wherein a room temperature region in the transport container is maintained within a range of 15C to 35C. The transport container according to claim 1, wherein a temperature measurement sensor having a temperature recorder is provided in the transport container, and the room temperature in the container can be continuously recorded. The transport container for a cell tissue medical device according to claim 1, wherein the inner container is formed of a general-purpose heat insulating material such as styrene foam or urethane foam, and the heat storage gel is stored and arranged in the inner container. The transport container according to claim 1, wherein the outer container is formed of a general-purpose heat insulating material such as styrene foam or urethane foam and a high-performance heat insulating material such as a vacuum heat insulating panel. The cell tissue according to claim 1, wherein a heating device including a gas supply unit, a heating unit, and a temperature control unit is provided in the transport container, and the heating unit generates heat by a method using an oxidation catalyst. Transport container for medical equipment. 2. The transport container for a cell tissue medical device according to claim 1, wherein the temperature recorder is housed in the outer container, and the outer container is of a housing type.

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