JP4190898B2 - Transport container for cell tissue medical devices - Google Patents

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]
BACKGROUND OF THE INVENTION
The present invention relates to a transport container capable of reliably transporting a tissue tissue medical device containing animal cells within a room temperature region and without reducing cell viability.
[0002]
[Prior art]
Conventionally, when a cell tissue medical device containing cells is transported from a manufacturing factory to a medical facility that is actually used, most of them are transported in a frozen state.
[0003]
[Problems to be solved by the invention]
Such transport means is a simple method, but there is a risk that cells may be damaged and killed during thawing. To prevent this, extremely complicated and cumbersome thawing work, skilled technology, special equipment Cost.
Therefore, in the case of such frozen transport, the above disadvantages are compensated by setting a large initial cell amount in consideration of a decrease in viable cells.
[0004]
However, in this case, the number of cells can be ensured by using allogeneic cells. However, 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 is further reduced in the thawing process. There was a problem with this method. In addition, when the appropriate thawing operation is not performed, the number of viable cells is remarkably reduced, and depending on the situation at the time of use, the activation of the cells is also a factor. In addition, the transportation in the room temperature region has a drawback that transportation is limited to a short distance due to the limited heat retention time, and a large-sized device 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 from a two-layer structure of an inner container and an outer container, and the inner container is provided with a function of buffering heat storage and heat transfer, and the outer container is provided with a heat insulating function and a heating function. By providing this, transportation in the room temperature region was facilitated. In addition, this enables reliable transport without reducing the survival rate of cultured cells such as artificially cultured skin as much as possible.
However, the present invention is characterized by the following configurations.
Item 1. The transport container is formed from a two-layer structure of an inner container and an outer container, and the inner container is provided with a function of buffering heat storage and heat transfer, and the outer container is provided with a heat insulating function to be transported in a room temperature region. A transport container for a cellular tissue medical device, characterized in that
Item 2. The transport container for a cellular tissue medical device according to Item 1, wherein the room temperature region in the transport container is maintained within a range of 15 ° C to 35 ° C.
Item 3. The transport container for a cellular tissue medical device according to Item 1, wherein a temperature measuring sensor having a temperature recorder is provided in the transport container so that the room temperature in the container can be continuously recorded.
Item 4. The transport container for a cellular tissue medical device according to Item 1, wherein the inner container is formed of a general-purpose heat insulating material such as polystyrene foam or urethane foam, and a heat storage gel is housed and disposed in the inner container. .
Item 5. Item 2. The transport container for a cellular tissue medical device according to Item 1, wherein the outer container is formed of a general-purpose heat insulating material such as polystyrene foam or urethane foam and a high performance heat insulating material such as a vacuum heat insulating panel.
Item 6. Item 2. The cellular tissue medical treatment according to item 1, wherein a heating device including a gas supply unit, a heat generation unit, and a temperature control unit is provided in the transport container, and the heat generation of the heat generation unit is performed by a method using an oxidation catalyst. Transport container for tools.
Item 7. The container for transporting a tissue tissue medical device according to Item 1, wherein the temperature recorder is housed in the outer container and the outer container is made to be a pass-through type.
[0006]
In the present invention, the material for forming the inner container and the outer container is formed of a material having excellent heat insulation, and the outer container is provided with a heat insulating portion such as a vacuum heat insulating panel, and the inner container is a bag. The contained heat storage polymer was arranged as a buffer material for buffering heat transfer, so that the temperature of the transport container could be kept in the predetermined temperature range as much as possible without being affected by the surrounding external environment. The preferred temperature range for cell survival 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 in these room temperature regions. It is possible to keep warm.
[0007]
In addition, by providing a heating mechanism inside the outer container to raise or keep the temperature in the transport container by oxidizing and exothermic gas with a chemical catalyst as an active heating device as necessary, There is no need to equip heavy equipment or a large-sized device such as an external power source or a battery. Therefore, there is an advantage that the transport container is compact and lightweight and easy to handle. Delivery can be easily performed by so-called courier service or the like.
[0008]
In addition, it is necessary to record the product temperature in the container in order to ensure that the above room temperature range is maintained during transportation, but in practice, the temperature of the product that is a tissue tissue medical device is directly measured. As a substitute index, a temperature measuring device is provided in the inner container to measure the temperature in the inner container, and the temperature recorder provided in the outer container and the temperature measuring device is cabled. And the room temperature is continuously recorded.
[0009]
In other words, it is important to record whether the room temperature in the transport container is maintained within the room temperature range without being affected by the surrounding external environment. A device that can automatically measure and record at every interval and is small and lightweight is installed. In addition, by making the outer container in which the above-mentioned temperature recorder is stored, the room temperature data obtained by continuously measuring the room temperature in the transport container can be easily collected, and the room temperature can be managed. I try to make it convenient.
[0010]
DETAILED DESCRIPTION OF THE INVENTION
[Example 1]
The contents of the present invention will be described below 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 the top. Reference numeral 1 denotes a transport container for a cell tissue medical device, 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 are each provided with a hermetically sealed upper lid connected by a hinge or the like. Reference numeral 5 denotes a vacuum heat insulating panel layer provided on the inner periphery of the outer container 3, and reference numeral 7 denotes a heating device chamber provided inside the outer container 3. A heating device 8 and a temperature recorder 9 are accommodated in the 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 housed to prevent damage during transportation of the container. Further, 15 is a heat storage polymer in a bag provided inside the inner container 3, and a plastic containing a cell tissue medical device (not shown) as a product inside the polymer 15, or A glass product case 16 is stored. Note that a temperature measuring sensor 17 for detecting temperature is provided in the part, and this is connected to a temperature recorder 9 provided in the heating device installation chamber 7 of the outer container 3 through a cable 18. The indoor temperature is recorded at regular intervals.
Further, 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 and a temperature control unit 22 using an oxidation catalyst, and a flow rate adjusting valve 23. Composed.
[0012]
Examples of the inner container 2 and the outer container 3 of the transport container 1 include, but are not limited to, foamed polystyrene and urethane foam that are excellent in heat insulation. Moreover, as a material which comprises the outer container 2 which plays a role as a cool box, you may use the versatile heat insulating material which is excellent in heat insulation similarly to the inner container 2, However, when the change of an external environment is considered, it is still more efficient. Things are desired. As a specific example, there is a vacuum heat insulating panel and the like, for example, “N'sVIP” (trade name) manufactured by Nisshinbo Industries, Ltd. and the like. Moreover, as an example of the cool box which applied the vacuum heat insulation panel, for example, “RYOBI Pro Target Super HEXA” (trade name) manufactured by Joshuya Co., Ltd. can be cited.
[0013]
Around the product case 16 accommodated in the inner container 2, the heat storage polymer 15 as described above, specifically, a heat storage agent and a heat transfer buffer material are arranged. Examples of these materials include known cold-retaining agents and heat-retaining agents, but heat storage agents to which a heat buffering action by heat of solidification or heat of fusion is applied can also be used. However, those that liquefy due to temperature changes are less preferred because heat transfer is promoted by convection.
[0014]
An example of the active heating device 8 is a heat generation method using an oxidation catalyst. Its features are that it does not require an external power supply, etc., does not generate flames due to chemical heat generation, has excellent safety, and can easily control the amount of heat generated. is there. As a method of heat generation, outside air (oxygen) is taken in by the air intake pipe 10, the gas flow rate is adjusted and supplied by the flow rate adjusting valve 23 through the control by the temperature control unit 22, and the chemical catalyst is used. It causes oxidation heat generation. As a specific example, for example, “heating device of heating vest NQ-HV30 / LS” (trade name) manufactured by Matsushita Electric Industrial Co., Ltd. can be exemplified.
[0015]
In addition, 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 refers to, for example, artificial skin, blood vessels, or the like in which living cells are seeded and cultured on a substrate such as collagen, biodegradable absorbable polymer, or a composite thereof. Examples thereof include a material for repairing tissues constituting a living body such as bone and cartilage.
[0017]
Furthermore, the room temperature region in the present invention refers to a temperature region preferable for cell survival, and the room temperature in the present invention is preferably in the range of 10 ° C. to 37 ° C., particularly in the range of 15 ° C. to 30 ° C., If the temperature is higher or lower than this temperature range, the viability and proliferation rate of the cells are lowered, and the performance as a cell tissue medical device may be lowered.
[0018]
Moreover, the temperature monitoring at the time of transportation is necessary to guarantee whether or not the above-mentioned room temperature region is always maintained, and is further necessary to record the temperature of the product in the inner container. In practice, the temperature of the inner container is measured as a substitute index instead of directly measuring the temperature of the product. In other words, even if the external environment around the transport container is extremely high or low than the normal room temperature, the room temperature in the transport container is not affected by the room temperature range. It is necessary to record whether or not
[0019]
Therefore, the temperature recorder 9 with a recorder is desired to be able to automatically measure and record the time and temperature at regular intervals, and to be small and lightweight. As a product example of such a temperature recorder 9, for example, “Data Logger Series TL3633” (trade name) manufactured by As One Co., Ltd., and the like can be given.
Next, effects of the present invention will be described together with comparative examples.
[0020]
[Example 2]
3 shows a schematic cross-sectional view of the transport container 30 based on the first embodiment. In the case of FIG. 3, the heating device 8 shown in FIG. Is inserted with a temperature measuring sensor 35 in place of the cell tissue medical device as a product, 36 is a temperature measuring sensor provided in the outer container 2, and 37 is a temperature measuring sensor provided outside the transport container 30. The sensors 35, 36 and 37 are each provided with a temperature recorder (not shown) which records the temperature at regular intervals. Regarding the size of the container, first, as the product case 16, a plastic case made of polyacrylate having a width of 110 mm, a length of 80 mm, a height of 33 mm, and a plate thickness of 2.5 mm is used, and temperature recording is performed instead 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 housed in the container 2 made of styrene foam having a width of 270 mm, a height of 195 mm, a height of 205 mm, and a plate thickness of 20 mm as the inner container 2, and the weight is about 4.5 kg. It arrange | positioned in the inner side container 2 so that the merchandise case 16 may be surrounded by the heat storage polymer 15,15. 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 in which the product case 16 and the like are housed is housed in the container 3 having a width of 510 mm, a height of 295 mm, a height of 310 mm, and a plate thickness of 40 mm. The gap between the vacuum heat insulation panel 5 attached to the inner surface of the outer container 3 and the inner container 2 was filled with a cushioning material 12 made of styrene foam serving as a spacer, and a temperature measuring sensor 36 was inserted. The transport container 30 packed in this way is left in an environment in which the temperature is adjusted to 50 ° C. during a high temperature environment test and −5 ° C. during a low temperature environment test, respectively, and the heat retaining performance due to temperature changes in the product case 16 Was measured. The results are shown in Table 1.
[0023]
[Comparative Example 1]
FIG. 4 shows a transport container 60 based on Comparative Example 1, and in contrast to the transport container 30 of Example 1 as shown in FIG. 3, the outer container 3 with the vacuum heat insulation panel 5 is removed, that is, The transport container 60 is formed only from the product case 16 containing the temperature measurement sensor 35 and the inner container 2 in which the heat storage polymer 15 is stored, and the heat retention performance due to temperature change in the product case 16 is measured as in the first embodiment. did. The results are shown in Table 1.
[0024]
[Comparative Example 2]
FIG. 5 shows the transport container 70 based on the comparative example 2, and the transport container 70 is formed only by the product inner case 16 containing the temperature measuring sensor 35 and the inner container 2 in which the foamed cushioning material 12 is housed. Thus, the heat retention performance due to the temperature change in the product case 16 was measured in the same manner as in Example 1. The results are shown in Table 1.
[0025]
[Table 1]

[0026]
As is apparent from the above results, Example 2 shows satisfactory heat retention performance of 20 hours or more in both high temperature and low temperature environment tests. On the other hand, in the comparative example, although the effect of the heat storage gel is recognized, the absence of the outer container indicates that the effect alone is insufficient.
[0027]
【The invention's effect】
In 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 is provided with a function of buffering heat storage and heat transfer, and the outer container is provided with a heat insulating function and a heating function. It is easy to transport in the room temperature region, and the tissue tissue medical device containing cultured cells such as artificially cultured skin can be reliably transported in the room temperature region without reducing the cell viability as much as possible. It can be done.
[Brief description of the drawings]
FIG. 1 is a schematic sectional view of a transport 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 cross-sectional view of a transportation container in Example 2 according to the present invention.
4 is a schematic cross-sectional view of a transport container in Comparative Example 1. FIG.
5 is a schematic cross-sectional view of a transportation container in Comparative Example 2. FIG.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Transport container 2 Inner container 3 Outer container 5 Vacuum heat insulation panel 8 Heating device 12 Buffer material 15 Thermal storage gel 16 Product case 17 Sensor for temperature measurement

Claims (2)

Two layers of an inner container that has a function of buffering heat transfer by storing and arranging a heat storage gel, and a versatile heat insulating material such as foamed polystyrene and urethane foam, and a high performance heat insulating material such as a vacuum heat insulating panel Formed from the structure,
Moreover, the room temperature region in the transport container is kept for 20 hours without using a power source. 5 ℃ ~ 3 5 ℃ A container for transporting a tissue tissue medical device, characterized in that the container is maintained within the above range. The cell tissue according to claim 1, wherein a heating device comprising 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.
1

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