Medical container

Abstract

To provide a medical container capable of preventing contamination of a biological sample stored within at the time of opening.　A medical container 5 includes: a first sheet-like part 51; a second sheet-like part 52 which is arranged so as to overlap the first sheet-like part 51 and forms a storage part 54 between itself and the first sheet-like part 51; a first seal part 55 which is formed outside the storage part 54 in the first sheet-like part 51 and the second sheet-like part 52 and in which the first sheet-like part 51 and the second sheet-like part 52 are sealed by heat; and a second seal part 56 which is formed outside the first seal part 55 with respect to the storage part 54 in the first sheet-like part 51 and the second sheet-like part 52, and in which the first sheet-like part 51 and the second sheet-like part 52 are sealed by heat with seal strength stronger than that of the first seal part 55.

Description

Medical containers

[0001] The present invention relates to a medical container used in medical treatment.

[0002] Conventionally, medical containers have been known in which an opening communicating with a container body is sealed by heat welding (see, for example, Patent Document 1). The medical container contains a biological sample such as cells, and the medical container is frozen and stored. The medical container described in Patent Document 1 is opened by cutting the opening portion with a cutting instrument.

[0003] Japanese Patent Application Laid-Open No. 2007-302567

[0004] When the medical container described in Patent Document 1 is opened by cutting the opening with a cutting tool, bacteria and the like may enter the inside of the medical container through the cutting tool, which may result in contamination of biological samples such as cells contained in the medical container with bacteria and the like.

[0005] An object of the present invention is to provide a medical container that can prevent contamination of a biological sample contained therein when the container is opened.

[0006] The present invention relates to a medical container comprising: a first sheet-like portion; a second sheet-like portion arranged to overlap the first sheet-like portion and forming a storage portion between the first sheet-like portion and the second sheet-like portion; a first seal portion formed outside the storage portion in the first sheet-like portion and the second sheet-like portion, where the first sheet-like portion and the second sheet-like portion are heat-sealed; and a second seal portion formed outside the first seal portion with respect to the storage portion in the first sheet-like portion and the second sheet-like portion, where the first sheet-like portion and the second sheet-like portion are heat-sealed with a seal strength stronger than that of the first seal portion.

[0007] It is also preferable that the first sheet-like portion and the second sheet-like portion have a third seal portion formed on the outer edge where the first seal portion and the second seal portion are not provided, and sealed by heat with a seal strength stronger than that of the first seal portion.

[0008] The present invention relates to a medical container for medical use, comprising: a first sheet-like member having a storage portion; a second sheet-like member laminated on the first sheet-like member and having a second sheet-like member opening hole in a portion corresponding to the storage portion; a third sheet-like member laminated on the second sheet-like member on the side opposite the first sheet-like member and formed to cover the storage portion; a first seal portion in which the first sheet-like member and the second sheet-like member, or the second sheet-like member and the third sheet-like member, are joined and sealed with a seal strength that allows them to be opened by hand; and a non-welded region member that is disposed between the two same sheet-like members as the two sheet-like members sealed by the first seal portion, in the circumferential direction of the storage portion avoiding the first seal portion in a plan view, and has a non-welded region member opening hole in a portion corresponding to the storage portion.

[0009] Furthermore, it is preferable that two of the first sheet-like member and the second sheet-like member, or the second sheet-like member and the third sheet-like member, that are not sealed by the first sealing portion have a second sealing portion that is heat-sealed with a sealing strength stronger than that of the first sealing portion at the portion stacked on the non-welded area member.

[0010] Preferably, the housing portion is formed by three-dimensional molding.

[0011] It is also preferable that a third seal portion be provided between the first sheet-like member and the second sheet-like member, the third seal portion being sealed so as to surround the first seal portion and the non-welded region member.

[0012] It is also preferable that one side of the medical container is provided with a tube between the first sheet-like member and the second sheet-like member, between the second sheet-like member and the third sheet-like member, or between the first sheet-like member and the third sheet-like member, which can introduce a protective agent from the outside into the storage section.

[0013] Furthermore, it is preferable that only one side of the medical container that has the tube is sealed with a seal strength stronger than that of the first seal portion, between the first sheet-like member and the second sheet-like member, the second sheet-like member and the third sheet-like member, or the first sheet-like member and the third sheet-like member.

[0014] It is also preferable that the medical container has a third seal portion sealed between the first sheet-like member and the second sheet-like member to surround the first seal portion and the non-welded region member, and that the first seal portion and the third seal portion seal the three sides of the medical container on which the tube is not positioned in a U-shape when viewed in a plane.

[0015] It is also preferable that the non-weld region member has an opening hole on only one side of the medical container where the tube is sealed.

[0016] Preferably, the housing portion is formed to have a rectangular cross section that extends in a predetermined direction.

[0017] The medical container is preferably used for cryopreservation.

[0018] It is also preferable that the first, second and third sheet members have marks that serve as guides for cutting when removing the contents.

[0019] According to the present invention, it is possible to provide a medical container that can prevent the biological sample contained therein from being contaminated when the container is opened.

[0020] 1 is a perspective view of a cryopreservation container according to a first embodiment of the present invention, as seen from an oblique side; FIG. 2 is a cross-sectional view taken along line A-A in FIG. 1; FIG. 3 is a side view showing a case where a biological sample is placed in a cryopreservation container according to the first embodiment; FIG. 4 is a side view showing a case where the cryopreservation container according to the first embodiment is opened; FIG. 5 is a cross-sectional view showing a case where the cryopreservation container according to the first embodiment is opened; FIG. 6 is a perspective view of a cryopreservation container according to a second embodiment of the present invention, as seen from an obliquely upper side; FIG. 7 is a perspective view of a cryopreservation container according to the second embodiment, as seen from an obliquely lower side; FIG. 8 is a plan view of a cryopreservation container according to the second embodiment; FIG. 9 is an exploded perspective view of a cryopreservation container according to the second embodiment; FIG. 10 is a schematic cross-sectional view taken along line B-B in FIG. 2; FIG. 11 is a schematic cross-sectional view taken along line C-C in FIG. 2; FIG. 12 is a diagram showing the positions of each sealing portion in the plan view of a cryopreservation container according to the second embodiment; FIG. 13 is a cross-sectional view showing a method of making a cryopreservation container according to the second embodiment; FIG. 14 is a plan view showing a method of making a cryopreservation container according to the second embodiment; FIG. 15 is a cross-sectional view showing a method of using a cryopreservation container according to the second embodiment; FIG. 16 is a plan view showing a method of using a cryopreservation container according to the second embodiment; FIG. 17 is a cross-sectional view of a cryopreservation container according to a third embodiment; FIG. 18 is a plan view of a cryopreservation container according to the third embodiment; FIG. 19 is a cross-sectional view of a cryop FIG. 10 is a plan view of a cryopreservation container according to a fourth embodiment.

[0021] Hereinafter, preferred embodiments of the cryopreservation container 5 as a medical container of the present invention will be described with reference to the drawings. The cryopreservation container 5 of the present invention is used in medical treatment to freeze and preserve biological samples such as cell sheets and other cells.

[0022] A cryopreservation container 5 according to a first embodiment will be described with reference to Figures 1 and 2. In the description of this embodiment, in a side view of the cryopreservation container 5, the direction along the vertical side of the container body 50 is referred to as the D1 direction, and the direction along the horizontal side of the container body 50 is referred to as the D2 direction. The D1 direction and the D2 direction are perpendicular to each other. The stacking direction of the multiple sheet-like portions 51, 52 of the container body 50 is referred to as the D3 direction.

[0023] As shown in FIGS. 1 and 2 , the cryopreservation container 5 of the first embodiment includes a container body 50 and a liquid introduction tube 60 into which a cryoprotective liquid 503 (see FIG. 2 ) can be introduced. The container body 50 has a storage section 54 between a first sheet-shaped section 51 and a second sheet-shaped section 52, and is formed into a bag shape with the outer edges of the first sheet-shaped section 51 and the second sheet-shaped section 52 sealed. The container body 50 is formed into a rectangular (substantially square) shape in side view. A cell sheet 501 is stored in the storage section 54. The cell sheet 501 is formed into a sheet shape by culturing cells collected from human tissue. Thus, when freezing the cryopreservation container 1, the storage section 54 is filled with the cryoprotective liquid 503 while containing the cell sheet 501, as shown in FIG. 5 . The cryopreservation container 5 is cryopreserved with a biological sample, such as a cell sheet, stored therein.

[0024] In this embodiment, a cell sheet is described as an example of a biological sample such as cells to be stored in the storage unit 54, but the biological sample is not limited to this. For example, the biological sample may be a tissue fragment in which cells form clumps. Alternatively, for example, a cell suspension containing cells may be stored in the storage unit 54 as the biological sample.

[0025] The container body 50 is configured such that a sheet-like portion 53, which is formed by continuously forming a first sheet-like portion 51 and a second sheet-like portion 52, is folded back in an arc at an end on one side D1a in the D1 direction and overlaps with another at an end on the other side D1b in the D1 direction, thereby overlapping the first sheet-like portion 51 and the second sheet-like portion 52. The first sheet-like portion 51 and the second sheet-like portion 52 are sealed at their outer edges except for the portion where the sheet-like portion 53 is folded back in an arc.

[0026] The first sheet-shaped portion 51, the second sheet-shaped portion 52, and the liquid introduction tube 60 are made of a flexible thermoplastic resin such as EVA resin (ethylene-vinyl acetate copolymer resin). The first sheet-shaped portion 51, the second sheet-shaped portion 52, and the liquid introduction tube 60 are made of a freeze-resistant material so that they can be frozen.

[0027] 1, the first sheet-like portion 51 and the second sheet-like portion 52 are joined together at a weak seal portion 55 (first seal portion), a strong seal portion 56 (second seal portion), a first sealing seal portion 57 (third seal portion), and a second sealing seal portion 58 (third seal portion). A storage portion 54 is formed between the first sheet-like portion 51 and the second sheet-like portion 52.

[0028] The weak seal portion 55, the strong seal portion 56, the first sealing seal portion 57 and the second sealing seal portion 58 are sealing portions formed by joining the first sheet-shaped portion 51 and the second sheet-shaped portion 52 using heat, such as heat sealing or ultrasonic sealing.

[0029] As shown in FIG. 1 , the weak seal portion 55 is formed outside the storage portion 54 on one side D2a in the direction D2 of the first sheet-shaped portion 51 and the second sheet-shaped portion 52 in side view. The weak seal portion 55 is formed linearly extending in the direction D1 in side view and seals the first sheet-shaped portion 51 and the second sheet-shaped portion 52 together. The weak seal portion 55 is a seal portion where the first sheet-shaped portion 51 and the second sheet-shaped portion 52 are sealed by heat with a seal strength that allows them to be opened by hand. The weak seal portion 55 has a seal strength that prevents the cryoprotectant liquid 503 (see FIG. 2 ) injected into the storage portion 54 from leaking out to the outside.

[0030] The strong seal portion 56 is formed on one side D2a in the D2 direction of the first sheet-like portion 51 and the second sheet-like portion 52, in a side view, outside the weak seal portion 55 with respect to the storage portion 54. The strong seal portion 56 is formed in a linear shape extending in the D1 direction along the outer edges of the first sheet-like portion 51 and the second sheet-like portion 52 at a position away from the weak seal portion 55, and seals the first sheet-like portion 51 and the second sheet-like portion 52 together. The strong seal portion 56 is a seal portion formed by heat sealing the first sheet-like portion 51 and the second sheet-like portion 52 with a seal strength stronger than that of the weak seal portion 55. The strong seal portion 56 is a seal portion that prevents the cryoprotectant liquid 503 injected into the storage portion 54 from leaking out, prevents the surrounding liquid nitrogen used during freezing from entering the inside, and has a seal strength that makes it impossible to open by hand.

[0031] The first sealing seal portion 57 and the second sealing seal portion 58 are formed on the outer edges of the first sheet-shaped portion 51 and the second sheet-shaped portion 52 in the parts that are not sealed by the weak sealing portion 55 and the strong sealing portion 56.

[0032] The first sealing portion 57 is formed at the outer edge of the end on the other side D2b in the D2 direction, extending linearly in the D1 direction, to seal the first sheet-like portion 51 and the second sheet-like portion 52. The second sealing portion 58 is formed at the end on the one side D1a in the D1 direction where the liquid introduction tube 60 is disposed in the D1 direction, to seal the first sheet-like portion 51 and the second sheet-like portion 52 with the liquid introduction tube 60 disposed between the first sheet-like portion 51 and the second sheet-like portion 52. The second sealing portion 58 extends linearly in the D2 direction at the end on the other side D1b in the D1 direction, to seal the first sheet-like portion 51 and the second sheet-like portion 52.

[0033] The first sealing portion 57 and the second sealing portion 58 are sealing portions that seal to prevent the cryoprotectant solution 503 injected into the storage portion 54 from leaking out. The first sealing portion 57 and the second sealing portion 58 have a seal strength that makes them impossible to open by hand, and are sealed by heat with a seal strength stronger than that of the weak sealing portion 55. The seal strength of the first sealing portion 57 and the second sealing portion 58 may be the same as or different from the seal strength of the strong sealing portion 56.

[0034] The liquid introduction tube 60 is attached to the end of the container body 50 on the other side D1b in the D1 direction, at the end on the other side D2b in the D2 direction. The liquid introduction tube 60 introduces liquid into the storage portion 54. The liquid introduction tube 60 is made of a thermoplastic resin such as EVA resin. In the first embodiment, the liquid introduction tube 60 is disposed between the first sheet-shaped portion 51 and the second sheet-shaped portion 52 so that one end of the liquid introduction tube 60 communicates with the storage portion 54. The other end of the liquid introduction tube 60 is aseptically and airtightly connected to a liquid storage container (not shown) that stores, for example, a cryoprotectant liquid 503.

[0035] Next, a method for storing a biological sample such as a cell sheet in the cryopreservation container 5 of the first embodiment will be described. As shown in FIG. 3 , the cryopreservation container 5 is factory-sealed at one end D2a in the D2 direction with a weak seal portion 55 and a strong seal portion 56, and at the other end D1b in the D1 direction with a second seal portion 58. Because both the weak seal portion 55 and the strong seal portion 56 are formed at the end D2a in the D2 direction, the cryopreservation container 5 can reliably maintain a sealed state. The cryopreservation container 5 is shipped with the outer edge of the end D2b in the D2 direction unsealed. The cryopreservation container 5 has an opening 531 formed at the outer edge of the end D2b in the D2 direction.

[0036] After shipping from the factory, the user places the cell sheet 501 in the storage section 54 by introducing it into the cryopreservation container 5 through the opening 531 formed on the outer edge of the end on the other side D2b in the D2 direction.

[0037] Next, the outer edge of the end on the other side D2b in the D2 direction is sealed with the first sealing member 57, as shown in Figure 4. Thereafter, a cryoprotectant 503 (see Figure 2) is introduced into the storage section 54 through the liquid introduction tube 60, and the opening of the liquid introduction tube 60 is sealed. In this way, the user can store and seal a biological sample such as a cell sheet 501 or other cells in the cryopreservation container 5. Thereafter, the cryopreservation container 5 containing the cell sheet 501 or other cells is cryopreserved.

[0038] Next, a method for opening the cryopreservation container 5 of the first embodiment will be described. When opening the cryopreservation container 5 to remove a biological sample such as the cell sheet 501 or other cells contained in the cryopreserved cryopreservation container 5, the frozen cryopreservation container 5 is first thawed.

[0039] 4 and 5, the outer edge 59 (end portion 51a of the first sheet-like portion 51 and end portion 52a of the second sheet-like portion 52) including the portion where the strong seal portion 56 of the container body 50 is formed is cut off with a cutting tool such as scissors. Note that the container body 50 may be provided with a notch for cutting off the outer edge 59 to make it easier to cut off the outer edge 59.

[0040] Next, as shown in the lower diagram of Figure 5, the first sheet-like portion 51 and the second sheet-like portion 52 are moved to one side and the other in the direction D3 at the outer edges thereof so that they move away from each other, and the first sheet-like portion 51 and the second sheet-like portion 52 are pulled apart at the weak seal portion 55 to open the container body 50.

[0041] The weak seal portion 55 has a seal strength sufficient to prevent the cryoprotective solution 503 injected into the storage portion 54 from leaking to the outside, and is heat-sealed to a seal strength sufficient for manual opening. This allows the first sheet-like portion 51 and the second sheet-like portion 52 to be easily peeled apart at the weak seal portion 55. When peeling the first sheet-like portion 51 and the second sheet-like portion 52 at the weak seal portion 55, all that is required is to remove the cell sheet 501 and other cells or other biological samples. The first sheet-like portion 51 and the second sheet-like portion 52 may be peeled apart at least partially at the weak seal portion 55. The first sheet-like portion 51 and the second sheet-like portion 52 may be peeled apart at the entire weak seal portion 55, or the first sheet-like portion 51 and the second sheet-like portion 52 may be peeled apart at only a portion of the weak seal portion 55.

[0042] This allows the container body 50 to be opened and the cell sheet 501 contained in the storage section 54 to be removed. Before the outer edge 59 including the strong seal section 56 is cut, the outer edge is sealed by the strong seal section 56, and after the strong seal section 56 is removed, the first sheet-shaped section 51 and the second sheet-shaped section 52 can be peeled apart and opened at the weak seal section 55. This prevents the cell sheet 501 contained in the storage section 54 from being contaminated.

[0043] The cryopreservation container 5 described above has an opening 531, which serves as an entrance for storing biological samples such as the cell sheet 501 and other cells, at the end on the other side D2b in the D2 direction, and a weak seal section 55 and a strong seal section 56, which serve as an exit for removing biological samples such as the cell sheet 501 and other cells, at the end on the one side D2a in the D2 direction. In other words, the cryopreservation container 5 has a separate entrance for storing biological samples such as the cell sheet 501 and other cells, and an exit for removing them.

[0044] The cryopreservation container 5 of the first embodiment described above provides the following effects.

[0045] (1) The cryopreservation container 5 is configured to include a first sheet-shaped portion 51, a second sheet-shaped portion 52 arranged to overlap the first sheet-shaped portion 51 and forming a storage portion 54 between the first sheet-shaped portion 51 and the second sheet-shaped portion 52, a weak seal portion 55 formed outside the storage portion 54 in the first sheet-shaped portion 51 and the second sheet-shaped portion 52 and where the first sheet-shaped portion 51 and the second sheet-shaped portion 52 are heat-sealed, and a strong seal portion 56 formed outside the first seal portion 55 with respect to the storage portion 54 in the first sheet-shaped portion 51 and the second sheet-shaped portion 52 and where the first sheet-shaped portion 51 and the second sheet-shaped portion 52 are heat-sealed with a seal strength stronger than that of the first seal portion 55.

[0046] Therefore, when opening the cryopreservation container 5, the outer edge 59 (end portion 51a of the first sheet-shaped portion 51, end portion 52a of the second sheet-shaped portion 52) including the portion where the strong seal portion 56 of the cryopreservation container 5 is formed is cut off, and then the first sheet-shaped portion 51 and the second sheet-shaped portion 52 are peeled apart at the weak seal portion 55 to open the cryopreservation container 5. Therefore, before cutting the outer edge 59 including the strong seal portion 56, the outer edge is sealed by the strong seal portion 56, and after removing the strong seal portion 56, the first sheet-shaped portion 51 and the second sheet-shaped portion 52 can be peeled apart and opened at the weak seal portion 55. Therefore, contamination of the cell sheet 501 contained inside the storage portion 54 can be suppressed when opening the cryopreservation container 5.

[0047] (2) The cryopreservation container 5 is configured to include a first sealing portion 57 and a second sealing portion 58 formed on the outer edges of the first sheet-shaped portion 51 and the second sheet-shaped portion 52 where the weak sealing portion 55 and the strong sealing portion 56 are not provided, and which are sealed by heat with a sealing strength stronger than that of the first sealing portion 55.

[0048] Here, the cryopreservation container 5 is produced at a factory by sealing the weak seal portion 55 and the strong seal portion 56, and at least partially sealing the first seal portion 57 and the second seal portion 58. For example, in this embodiment, the cryopreservation container 5 is shipped from the factory with the second seal portion 58 sealed and the first seal portion 57 unsealed. After shipping from the factory, a user can easily store a biological sample such as a cell sheet in the cryopreservation container 5 by placing the biological sample such as a cell sheet in the opening 531 (see FIG. 3 ) at the end portion on the other side D2b in the D2 direction of the cryopreservation container 5 and sealing it with the first seal portion 57.

[0049] A cryopreservation container 1 according to a second embodiment will be described with reference to Figures 6 to 12. In the description of this embodiment, the direction in which one side of the rectangular container body 10 extends in a plan view of the cryopreservation container 1 is referred to as the X direction, and the direction in which the other side of the container body 10 extends is referred to as the Y direction. The X direction and the Y direction are perpendicular to each other. The stacking direction of the multiple sheet-like members 11, 12, 13, and 14 of the container body 10 is referred to as the Z direction.

[0050] As shown in Figures 6 to 9, the cryopreservation container 1 of the second embodiment includes a container body 10 and a liquid introduction tube 20 (tube) into which a cryoprotective liquid 103 (protective agent) (see Figure 10) can be introduced. The container body 10 is configured by stacking a plurality of sheet-like members 11, 12, 13, and 14. In the container body 10, a cell sheet 101 is accommodated in a three-dimensional accommodation section 112 (described below) formed in the first sheet-like member 11. The cryopreservation container 1 is cryopreserved with a biological sample, such as a cell sheet, accommodated therein.

[0051] As shown in FIGS. 8 to 12 , the container body 10 comprises a first sheet-like member 11, a heat-resistant sheet-like member 12, a second sheet-like member 13, a third sheet-like member 14, a weak seal portion 15 (first seal portion), a strong seal portion 16 (third seal portion), a sealing seal portion 17 (second seal portion), and a liquid introduction tube-side sealing seal portion 18. The first sheet-like member 11, the second sheet-like member 13, and the third sheet-like member 14 are made of a flexible thermoplastic resin such as EVA resin (ethylene-vinyl acetate copolymer resin). The heat-resistant sheet-like member 12 is made of a heat-resistant material such as PTFE (polytetrafluoroethylene). The first sheet-like member 11, the heat-resistant sheet-like member 12, the second sheet-like member 13, and the third sheet-like member 14 are made of a freeze-resistant material so that they can be frozen.

[0052] As shown in Figure 9, the container body 10 is formed by stacking a first sheet-like member 11, a heat-resistant sheet-like member 12, a second sheet-like member 13, and a third sheet-like member 14, and by partially joining any two sheet-like members together at a weak seal portion 15, a strong seal portion 16, a sealing seal portion 17, and a liquid introduction tube side sealing seal portion 18, as shown in Figures 10 to 12.

[0053] As shown in Fig. 9, the first sheet-like member 11, the heat-resistant sheet member 12, the second sheet-like member 13, and the third sheet-like member 14 are stacked in this order from one side Z1 to the other side Z2 in the Z direction. With the first sheet-like member 11, the heat-resistant sheet member 12, the second sheet-like member 13, and the third sheet-like member 14 stacked, the container body 10 is formed in a substantially rectangular shape in a plan view, as shown in Fig. 8, with one side extending in the X direction and the other side extending in the Y direction. The liquid introduction tube 20 is attached to one end of the container body 10 in the Y direction. The liquid introduction tube 20 is disposed on one side of the cryopreservation container 1, between the first sheet-like member 11 and the third sheet-like member 14. The liquid introduction tube 20 is capable of introducing a cryoprotective liquid 103 (see Fig. 10) into the container body 10. In addition, the liquid introduction tube 20 may be configured to be placed between the first sheet-like member 11 and the second sheet-like member 13 on one side of the cryopreservation container 1, or may be configured to be placed between the second sheet-like member 13 and the third sheet-like member 14.

[0054] 9, the first sheet-like member 11 has a storage-section-surrounding sheet-like portion 111 and a three-dimensional storage section 112 (storage section). The storage-section-surrounding sheet-like portion 111 is formed in a substantially rectangular shape in a plan view, with one side extending in the X direction and the other side extending in the Y direction.

[0055] The three-dimensional containing section 112 is formed by three-dimensional molding as shown in Figures 9 to 11. The three-dimensional containing section 112 is formed into a three-dimensional shape that is recessed from the containing section-surrounding sheet-shaped section 111 on the inside of the containing section-surrounding sheet-shaped section 111 in a plan view. The three-dimensional containing section 112 contains biological samples such as the cell sheet 101 and other cells. The three-dimensional containing section 112 has a containing section main body 113.

[0056] The housing body 113 has a circular shape in a plan view. As shown in Fig. 10 , the cross section of the housing body 113 cut along the X direction is formed into a rectangular shape extending in the Y direction, and as shown in Fig. 11 , the cross section of the housing body 113 cut along the Y direction is formed into a rectangular shape extending in the Y direction.

[0057] A liquid introduction tube 20 disposed at one end of the container body 10 in the Y direction communicates with the three-dimensional container section 112 on one side in the Y direction. A cryoprotective solution 103 (see FIG. 10 ) is introduced into the three-dimensional container section 112 via the liquid introduction tube 20 while the cell sheet 101 is contained therein. The cell sheet 101 is formed into a sheet by culturing cells collected from human tissue. In this embodiment, the cell sheet 101 is formed into a disk shape with a diameter slightly smaller than the inner diameter of the three-dimensional container section 112 so that it can be contained in the three-dimensional container section 112. Thus, when freezing the cryopreservation container 1, the three-dimensional container section 112 is filled with the cryoprotective solution 103 while containing the cell sheet 101, as shown in FIG. 10 . Note that, in this embodiment, a cell sheet is used as an example of a biological sample, such as cells, contained in the three-dimensional container section 112, but this is not limiting. For example, the biological sample may be a cell mass (spheroid), which is a mass formed by the aggregation of cells. Furthermore, for example, a cell suspension containing cells as a biological sample may be contained in the three-dimensional containing section 112 .

[0058] The heat-resistant sheet member 12 is stacked on the other side Z2 of the first sheet member 11 in the Z direction. The heat-resistant sheet member 12 is formed in a U-shape with a predetermined width that opens on the liquid introduction tube 20 side at a position away from the three-dimensional storage section 112 in a plan view. The heat-resistant sheet member 12 has an opening 121 (heat-resistant sheet member opening) in a portion corresponding to the three-dimensional storage section 112. The opening 121 of the heat-resistant sheet member 12 is open only on one side of the cryopreservation container 1 where the liquid introduction tube 20 is sealed. The opening 121 is open on the liquid introduction tube 20 side in the Y direction so as to avoid the three-dimensional storage section 112 and open over a wider area than the three-dimensional storage section 112. 10 and 12, the heat-resistant sheet member 12 is disposed between the first sheet member 11 and the second sheet member 13 (described later) in a position where the weak seal portion 15 (described later) and the strong seal portion 16 (described later) are not formed in a plan view, and in the circumferential direction of the three-dimensional storage section 112, avoiding the weak seal portion 15 and the strong seal portion 16. The predetermined width of the heat-resistant sheet member 12 is preferably the same as that of the sealing portion 17 (described later), because the sealing portion 17 is sealed in the portion laminated on the heat-resistant sheet member 12, and is, for example, preferably 2 to 20 mm, more preferably 10 to 15 mm.

[0059] As shown in Fig. 9 , the second sheet-like member 13 is stacked on the other side Z2 of the first sheet-like member 11 in the Z direction, with the heat-resistant sheet member 12 sandwiched between them. That is, the second sheet-like member 13 is stacked on the other side Z2 of the heat-resistant sheet member 12 in the Z direction. The second sheet-like member 13 is formed in a U-shape in a plan view, with the liquid introduction tube 20 side open at a position that avoids the three-dimensional storage section 112. The second sheet-like member 13 has an opening 131 (second sheet-like member opening) in a portion corresponding to the three-dimensional storage section 112. The opening 131 has a shape that corresponds to the three-dimensional storage section 112 so as to avoid the three-dimensional storage section 112, and is open on the liquid introduction tube 20 side in the Y direction.

[0060] The third sheet-like member 14 is arranged in a stacked manner on the other side Z2 of the second sheet-like member 13 in the Z direction (the opposite side of the second sheet-like member 13 from the first sheet-like member 11). The third sheet-like member 14 is formed in a planar shape that is the same size as the outer shape of the first sheet-like member 11 in a plan view, and is formed so as to cover the three-dimensional storage section 112 of the first sheet-like member 11.

[0061] 10 and 12, the weak seal portion 15, the strong seal portion 16, the sealing seal portion 17, and the liquid introduction tube side sealing seal portion 18 are sealing portions formed by joining any two of the first sheet-like member 11, the second sheet-like member 13, and the third sheet-like member 14 by heat sealing, ultrasonic sealing, or the like. Note that the weak seal portion 15, the strong seal portion 16, the sealing seal portion 17, and the liquid introduction tube side sealing seal portion 18 are not limited to sealing portions joined by heat. For example, they may be sealing portions joined by high-frequency welding or ultrasonic welding.

[0062] As shown in FIG. 12 , the weak seal portion 15 is formed on the outer periphery of the three-dimensional storage portion 112 of the first sheet-like member 11 in a planar view at the outer edge of the three-dimensional storage portion 112. The weak seal portion 15 seals three sides of the cryopreservation container 1 where the liquid introduction tube 20 is not disposed. The weak seal portion 15 is formed in a U-shape in a planar view, opening toward the liquid introduction tube 20, and seals the first sheet-like member 11 and the second sheet-like member 13 together, as shown in FIG. 10 , so as to surround the outer periphery of the three-dimensional storage portion 112 of the first sheet-like member 11. The weak seal portion 15 is a seal portion formed by heat sealing the first sheet-like member 11 and the second sheet-like member 13 with a seal strength that allows the first sheet-like member 11 and the second sheet-like member 13 to be opened by hand. The weak seal portion 15 has a seal strength that prevents the cryoprotectant liquid 103 injected into the three-dimensional storage portion 112 from leaking out.

[0063] As shown in FIG. 12 , the strong seal portion 16 is formed on the outer periphery of the first sheet-like member 11, further outward than the weak seal portion 15 with respect to the three-dimensional storage portion 112 in a plan view. The strong seal portion 16 seals three sides of the cryopreservation container 1 on the outer periphery of the weak seal portion 15, where the liquid introduction tube 20 is not positioned. The strong seal portion 16 seals the first sheet-like member 11 and the second sheet-like member 13 at a position spaced outward from the outer edge of the U-shaped portion of the weak seal portion 15, along the outer edges of the first sheet-like member 11 and the second sheet-like member 13, so as to surround the liquid introduction tube 20 side in a U-shape with a predetermined width that is open, as shown in FIG. 10 . The strong seal portion 16 seals between the first sheet-like member 11 and the second sheet-like member 13, so as to surround the periphery of the weak seal portion 15 and the heat-resistant sheet-like member 12. The strong seal portion 16 is a seal portion where the first sheet-like member 11 and the second sheet-like member 13 are sealed by heat with a seal strength stronger than that of the weak seal portion 15. The strong seal portion 16 is a seal portion that is sealed so that the surrounding liquid nitrogen does not come into contact with the weak seal portion 15 when frozen and so that the heat-resistant sheet-like member 12 does not come into contact with liquid nitrogen, and has a seal strength that makes it difficult for a person to open by hand.

[0064] As shown in Figure 12, the sealing seal portion 17 is formed between the weak seal portion 15 and the strong seal portion 16 in a plan view, and seals in a U-shaped manner with a predetermined width that opens to the liquid introduction tube 20 side. The sealing seal portion 17 is formed in at least a portion of the position where the heat-resistant sheet member 12 is disposed in a plan view. The predetermined width of the sealing seal portion 17 is preferably, for example, 2 to 20 mm, and more preferably 10 to 15 mm. This prevents the sealing seal portion 17 from shifting and overlapping with other seal portions, ensuring reliable sealing at the sealing position.

[0065] 10 , the sealing portion 17 is a sealing portion that seals the portion where the second sheet-like member 13 and the third sheet-like member 14, which are not sealed by the weak seal portion 15 and the strong seal portion 16, are laminated on the heat-resistant sheet-like member 12 to prevent the cryoprotectant liquid 103 injected into the three-dimensional storage portion 112 from leaking out. The sealing portion 17 has a seal strength that makes it difficult for a person to open it by hand, and is sealed by heat with a seal strength stronger than that of the weak seal portion 15. The seal strength of the sealing portion 17 may be the same as or different from the seal strength of the strong seal portion 16.

[0066] 12 , the liquid introduction tube side sealing portion 18 seals the first sheet-shaped member 11 and the third sheet-shaped member 14 at the end on the liquid introduction tube 20 side in the Y direction, with the liquid introduction tube 20 positioned between the first sheet-shaped member 11 and the third sheet-shaped member 14. The liquid introduction tube side sealing portion 18 seals the first sheet-shaped member 11 and the third sheet-shaped member 14 only on one side of the cryopreservation container 1 that includes the liquid introduction tube 20, with a seal strength stronger than that of the weak seal portion 15. The liquid introduction tube side sealing portion 18 is a seal portion that has a seal strength that makes it difficult for a person to open it by hand.

[0067] The liquid introduction tube 20 introduces liquid into the three-dimensional storage section 112. The liquid introduction tube 20 is made of a thermoplastic resin such as EVA resin. In the second embodiment, the liquid introduction tube 20 is disposed between the first sheet-shaped member 11 and the second sheet-shaped member 13 so that one end thereof communicates with the three-dimensional storage section 112 of the first sheet-shaped member 11. The other end of the liquid introduction tube 20 is aseptically and airtightly connected to a liquid storage container (not shown) that contains, for example, a cryoprotectant liquid 103.

[0068] As shown in Figures 6 to 8, the first sheet-like member 11, the second sheet-like member 13, and the third sheet-like member 14 have marks 115, 116 that serve as cutting guides when removing the contents. In this embodiment, the mark 115 is a mark for cutting the stacked first sheet-like member 11, the second sheet-like member 13, and the third sheet-like member 14 along the X direction. The mark 116 is a mark for cutting the stacked first sheet-like member 11, the second sheet-like member 13, and the third sheet-like member 14 along the Y direction. As shown in Figure 9, the marks 115, 116 are formed by overlapping a pair of recesses 11d, 11e of the first sheet-like member 11, a pair of recesses 13d, 13e of the second sheet-like member 13, and a pair of recesses 14d, 14e of the third sheet-like member 14.

[0069] A pair of recessed portions 11d, 11e of the first sheet-like member 11, a pair of recessed portions 13d, 13e of the second sheet-like member 13, and a pair of recessed portions 14d, 14e of the third sheet-like member 14 are arranged overlapping each other in a planar view when the first sheet-like member 11, the second sheet-like member 13, and the third sheet-like member 14 are stacked.

[0070] 12 , the pair of recessed portions 11 d of the first sheet-like member 11, the pair of recessed portions 13 d of the second sheet-like member 13, and the pair of recessed portions 14 d of the third sheet-like member 14 are formed as recesses recessed inward in the X direction at both ends in the X direction on the liquid introduction tube 20 side of a strong seal portion 16 extending in the X direction formed at the end opposite the side where the liquid introduction tube 20 is disposed in the Y direction of the cryopreservation container 1. The pair of recessed portions 11 e of the first sheet-like member 11, the pair of recessed portions 13 e of the second sheet-like member 13, and the pair of recessed portions 14 e of the third sheet-like member 14 are formed as recesses recessed inward in the Y direction toward the liquid introduction tube 20 side in the X direction on the end opposite the side where the liquid introduction tube 20 is disposed in the Y direction, on the X direction side of the strong seal portion 16 extending in the Y direction formed at both ends in the X direction of the cryopreservation container 1.

[0071] The mark 115 is formed by overlapping a pair of recessed portions 11d of the first sheet-like member 11, a pair of recessed portions 13d of the second sheet-like member 13, and a pair of recessed portions 14d of the third sheet-like member 14, and is formed as a recess that is recessed inward in the X direction at both ends in the X direction, on the liquid introduction tube 20 side of the strong seal portion 16 that extends in the X direction and is formed at the end opposite the side where the liquid introduction tube 20 is placed in the Y direction of the cryopreservation container 1. This serves as a mark when cutting along the X direction.

[0072] The mark 116 is formed by overlapping a pair of recessed portions 11e of the first sheet-like member 11, a pair of recessed portions 13e of the second sheet-like member 13, and a pair of recessed portions 14e of the third sheet-like member 14, and is formed in a concave shape recessed toward the liquid introduction tube 20 in the Y direction at the end opposite to the side where the liquid introduction tube 20 in the Y direction is arranged, more inward in the X direction than the strong seal portions 16 extending in the Y direction formed at both end portions in the X direction of the cryopreservation container 1, thereby serving as a mark when cutting along the Y direction.

[0073] The marks 115 and 116 can be used to separate the strong seal portion 16 of the cryopreservation container 1. When separating the strong seal portion 16 of the cryopreservation container 1, either the marks 115 or 116 may be used.

[0074] For example, by cutting the first sheet-like member 11, the second sheet-like member 13, and the third sheet-like member 14 along the X direction from the mark 115, it is possible to separate the strong seal portion 16 extending in the X direction formed at the end of the cryopreservation container 1 opposite the side where the liquid introduction tube 20 is arranged in the Y direction. Thereafter, by cutting the first sheet-like member 11, the second sheet-like member 13, and the third sheet-like member 14 along the Y direction at both ends in the X direction, on the X-direction inside of the strong seal portion 16 extending in the Y direction, it is possible to separate the strong seal portion 16 extending in the Y direction formed at both ends in the X direction of the cryopreservation container 1.

[0075] In this way, by providing the mark 115 as a guide for cutting along the X direction, it is possible to cut along the X direction, and after cutting along the X direction, it is possible to cut along the Y direction.

[0076] Furthermore, by cutting the first sheet-like member 11, the second sheet-like member 13, and the third sheet-like member 14 along the Y direction from the mark 116, it is possible to separate the strong seal portions 16 extending in the Y direction that are formed on both end sides in the X direction of the cryopreservation container 1. Thereafter, by cutting the first sheet-like member 11, the second sheet-like member 13, and the third sheet-like member 14 along the X direction at the end opposite to the side where the Y-direction liquid introduction tube 20 is disposed, on the Y-direction liquid introduction tube 20 side of the strong seal portion 16 extending in the X direction, it is possible to separate the strong seal portion 16 that is formed at the end opposite to the side where the liquid introduction tube 20 is disposed.

[0077] In this way, by providing the mark 116 that serves as a guide for cutting along the Y direction, it is possible to cut along the Y direction, and after cutting along the Y direction, it is possible to cut along the X direction.

[0078] Next, we will explain a method for storing a biological sample such as a cell sheet in the cryopreservation container 1. As shown in the upper diagram of Fig. 13 and the left diagram of Fig. 14, the cryopreservation container 1 is produced in a factory by stacking a first sheet-like member 11, a heat-resistant sheet-like member 12, and a second sheet-like member 13 and sealing them at the weak seal portion 15 and the strong seal portion 16. When the cryopreservation container 1 is shipped from the factory, the third sheet-like member 14 is shipped with only the liquid introduction tube side sealing portion 18 sealed.

[0079] After shipping from the factory, the cryopreservation container 1 is in a state in which the first sheet-like member 11, the heat-resistant sheet-like member 12, and the second sheet-like member 13 are stacked and arranged, and sealed at the weak seal portion 15 and the strong seal portion 16, as shown in the middle diagram of Figure 13 and the left diagram of Figure 14.The user then places the cell sheet 101 in the three-dimensional storage portion 112.

[0080] Next, as shown in the middle and bottom diagrams of Figure 13, the third sheet-like member 14 is placed on the other side Z2 of the second sheet-like member 13, and the second sheet-like member 13 and the third sheet-like member 14 are sealed by the sealing portion 17 at the portion where they are laminated on the heat-resistant sheet-like member 12.

[0081] In this case, since a heat-resistant sheet member 12 is arranged on one side Z1 of the second sheet member 13 and the third sheet member 14, the first sheet member 11 does not melt due to heat, and the second sheet member 13 and the third sheet member 14 are sealed together.

[0082] 13, a cryoprotectant 103 is then introduced into the three-dimensional container 112 using the liquid introduction tube 20, and the opening of the liquid introduction tube 20 is sealed. In this way, the user can store and seal a biological sample such as a cell sheet 101 or other cells in the cryopreservation container 1. The cryopreservation container 1 containing the cell sheet, other cells, etc. is then cryopreserved.

[0083] Next, a description will be given of a method for opening the cryopreservation container 1 of the second embodiment. When opening the cryopreservation container 1 to remove biological samples such as the cell sheet 101 or other cells contained in the cryopreserved cryopreservation container 1, the frozen cryopreservation container 1 is first thawed.

[0084] Next, as shown in the upper and middle diagrams of Figure 15 and Figure 16, the outer peripheral edge portion 19 (outside the end portion 11a of the first sheet-like member 11, the end portion 13a of the second sheet-like member 13, the end portion 14a of the third sheet-like member 14, and the sealing portion 17) including the portion where the strong sealing portion 16 of the container body 10 is formed is cut off using a cutting tool such as scissors.

[0085] 16 , by cutting the first sheet-like member 11, the second sheet-like member 13, and the third sheet-like member 14 in the X direction from the mark 115, it is possible to separate the strong seal portion 16 extending in the X direction formed at the end of the cryopreservation container 1 on the side opposite to the side where the liquid introduction tube 20 is arranged in the Y direction. Then, by cutting the first sheet-like member 11, the second sheet-like member 13, and the third sheet-like member 14 in the Y direction at both ends in the X direction, on the X-direction inside of the strong seal portion 16 extending in the Y direction, it is possible to separate the strong seal portion 16 extending in the Y direction formed at both ends in the X direction of the cryopreservation container 1.

[0086] Thereafter, the heat-resistant sheet member 12 disposed between the first sheet member 11 and the second sheet member 13 is removed. Next, as shown in the lower diagram of FIG. 15 , the outer edges of the first sheet member 11 and the second sheet member 13 are pulled toward one side Z1 and the other side Z2 in the Z direction so that the first sheet member 11 and the second sheet member 13 are separated from each other, and the first sheet member 11 and the second sheet member 13 are peeled apart at the weak seal portion 15, thereby opening the container body 10. The weak seal portion 15 has a seal strength sufficient to prevent the cryoprotectant liquid 103 injected into the three-dimensional storage portion 112 from leaking to the outside, is weaker in seal strength than the sealing seal portion 17, and is a heat-sealed seal portion with a seal strength that can be opened by hand. The second sheet member 13 is tightly sealed to the third sheet member 14, so that the first sheet member 11 and the second sheet member 13 can be easily peeled apart at the weak seal portion 15.

[0087] This allows the container body 10 to be opened and the cell sheet 101 contained in the three-dimensional containing section 112 to be removed. Before the outer periphery 19 including the strong seal section 16 is cut, the outer periphery is sealed by the strong seal section 16, and after the strong seal section 16 is removed, the first sheet-like member 11 and the second sheet-like member 13 can be peeled apart and opened at the weak seal section 15. This prevents the cell sheet 101 contained in the three-dimensional containing section 112 from being contaminated.

[0088] The cryopreservation container 1 of the second embodiment described above provides the following effects.

[0089] (3) The medical container 1 is configured to include a first sheet-like member 11 having a three-dimensional storage section 112, a second sheet-like member 13 laminated on the first sheet-like member 11 and having an opening hole 131, a third sheet-like member 14 laminated on the side of the second sheet-like member 13 opposite the first sheet-like member 11 and formed to cover the three-dimensional storage section 112, a weak seal section 15 in which the first sheet-like member 11 and the second sheet-like member 13 are joined and sealed with a seal strength that allows them to be opened by hand, and a heat-resistant sheet-like member 12 arranged between two sheet-like members (the first sheet-like member 11 and the second sheet-like member 13) that are the same as the two sheet-like members sealed with the weak seal section 15, in the outer circumferential direction of the three-dimensional storage section 112 avoiding the weak seal section 15 in a planar view, and having an opening hole 121 in a portion corresponding to the three-dimensional storage section 112.

[0090] Therefore, the cryopreservation container 1 is produced in a factory by stacking and arranging the first sheet-like member 11, the heat-resistant sheet-like member 12, and the second sheet-like member 13, and sealing them at the weak seal portion 15. This allows a user to easily store a biological sample such as a cell sheet in the cryopreservation container 1 when using it, by placing a biological sample such as a cell sheet in the cryopreservation container 1 and attaching the third sheet-like member 14 to the cryopreservation container 1. Then, by sealing the stack of the first sheet-like member 11, the heat-resistant sheet-like member 12, and the second sheet-like member 13 with the third sheet-like member 14, the cryopreservation container 1 containing the biological sample can be hermetically sealed.

[0091] (4) The cryopreservation container 1 is configured to have a sealing portion 17 that is heat-sealed with a stronger sealing strength than the weak sealing portion 15 in the portion where the second sheet-like member 13 and the third sheet-like member 14 that are not sealed by the weak sealing portion 15 are laminated on the heat-resistant sheet-like member 12.

[0092] As a result, when a biological sample such as a cell sheet is stored in the cryopreservation container 1 and the third sheet-like member 14 is attached, the second sheet-like member 13 and the third sheet-like member 14 are sealed with the sealing portion 17 at the portions where they are laminated to the heat-resistant sheet-like member 12, allowing the stored biological sample to be stored aseptically and allowing for aseptic removal without the user having to fine-tune the seal strength. The cryopreservation container 1 can be easily used. To open the cryopreservation container 1, the outer peripheral edge 19 (the end portion 11a of the first sheet-like member 11, the end portion 13a of the second sheet-like member 13, and the end portion 14a of the third sheet-like member 14) including the portion where the strong seal portion 16 of the container body 10 is formed is cut off, and then the first sheet-like member 11 and the second sheet-like member 13 are peeled apart at the weak seal portion 15 to open the container body 10. Therefore, before cutting the outer periphery 19 including the strong seal portion 16, the outer periphery is sealed by the strong seal portion 16, and after removing the strong seal portion 16, the first sheet-like member 11 and the second sheet-like member 13 can be peeled apart and opened at the weak seal portion 15. This prevents contamination of the cell sheet 101 contained in the three-dimensional container portion 112.

[0093] (5) The three-dimensional container section 112 is formed by three-dimensional molding, which allows the three-dimensional container section 112 to easily contain a biological sample such as a cell sheet.

[0094] (6) A strong seal portion 16 is provided between the first sheet-like member 11 and the second sheet-like member 13, and is sealed to surround the weak seal portion 15 and the heat-resistant sheet-like member 12. By providing the strong seal portion 16 on the outer periphery of the weak seal portion 15, the airtightness of the three-dimensional storage section 112 can be improved.

[0095] (7) On one side of the cryopreservation container 1, a liquid introduction tube 20 capable of introducing a cryoprotective liquid 103 from the outside into the three-dimensional storage section 112 is provided between the first sheet-shaped member 11 and the third sheet-shaped member 14. This allows the cryoprotective liquid 103 for protecting a biological sample such as a cell sheet to be easily introduced into the three-dimensional storage section 112.

[0096] (8) On only one side of the cryopreservation container 1 where the liquid introduction tube 20 is provided, the first sheet-like member 11 and the third sheet-like member 14 are sealed with a seal strength stronger than that of the weak seal portion 15. This makes the cryopreservation container 1 less likely to break, thereby improving breakage resistance.

[0097] (9) Between the first sheet-like member 11 and the second sheet-like member 13, there are weak seal portions 15 and strong seal portions 16 sealed to surround the heat-resistant sheet-like member 12, and the weak seal portions 15 and strong seal portions 16 are sealed in a U-shape in plan view on three sides of the cryopreservation container 1 where the liquid introduction tube 20 is not positioned. This allows biological samples such as cell sheets to be easily removed from the cryopreservation container 1 by cutting the cryopreservation container 1 along the three sides.

[0098] (10) The heat-resistant sheet member 12 has an opening 121 only on one side where the liquid introduction tube 20 of the cryopreservation container 1 is sealed. This allows the heat-resistant sheet member 12 disposed between the first sheet member 11 and the second sheet member 13 to be easily removed.

[0099] (11) The three-dimensional containing section 112 is formed to have a rectangular cross-sectional shape extending in a predetermined direction. This allows the thickness of the containing section in the three-dimensional containing section 112 to be constant, thereby improving the strength of the containing section.

[0100] (12) The cryopreservation container 1 is used for cryopreservation. Therefore, a medical container can be used as the cryopreservation container 1.

[0101] (13) The first sheet-like member 11, the second sheet-like member 13, and the third sheet-like member 14 are provided with marks 115 that serve as guides for cutting when removing the contents. This allows biological samples such as cell sheets to be easily removed from the cryopreservation container 1 by cutting the first sheet-like member 11, the second sheet-like member 13, and the third sheet-like member 14 using the marks 115 as guides.

[0102] Next, a cryopreservation container 1A of a third embodiment will be described. As shown in Figures 17 and 18, in the cryopreservation container 1A of the third embodiment, the first sheet-like member 11, the heat-resistant sheet member 12A, the second sheet-like member 13A, and the third sheet-like member 14 are stacked in the same order as the sheet-like members 11, 12, 13, and 14 of the second embodiment. However, compared to the cryopreservation container 1 of the second embodiment, the third embodiment differs mainly in the positions of the weak seal portion 15A and the sealing seal portion 17A and the shape and position of the heat-resistant sheet member 12A in a plan view. In the third embodiment, components similar to those of the second embodiment are designated by the same reference numerals and will not be described again.

[0103] 17 and 18, the container body 10A includes a first sheet-like member 11, a heat-resistant sheet member 12A, a second sheet-like member 13A, a third sheet-like member 14, a weak seal portion 15A, a strong seal portion 16, and a sealing seal portion 17A. As shown in Fig. 17, the first sheet-like member 11, the heat-resistant sheet member 12A, the second sheet-like member 13A, and the third sheet-like member 14 are stacked in this order from one side Z1 to the other side Z2 in the Z direction, similar to the second embodiment.

[0104] In the third embodiment, the heat-resistant sheet member 12A is formed in a U-shape along the outer edge of the three-dimensional storage section 112, as shown in FIG. 18 , whereas the heat-resistant sheet member 12 in the second embodiment is positioned away from the three-dimensional storage section 112 in plan view. The heat-resistant sheet member 12A is formed in a U-shape that is open on the side where the liquid introduction tube 20 is located in the Y direction. The heat-resistant sheet member 12A has an opening 121A (heat-resistant sheet member opening) in a portion corresponding to the three-dimensional storage section 112. The opening 121A has a shape that corresponds to the three-dimensional storage section 112 so as to avoid the three-dimensional storage section 112, and is open on the side facing the liquid introduction tube 20 in the Y direction.

[0105] In plan view, the weak seal portion 15A of the second embodiment is formed along the outer edge of the three-dimensional storage section 112, whereas in the third embodiment, the weak seal portion 15A is located away from the three-dimensional storage section 112 and seals the first sheet-like member 11 and the second sheet-like member 13A in a U-shaped portion of a predetermined width that is open on the side where the liquid introduction tube 20 in the Y direction is positioned, as shown in Figure 17.

[0106] In plan view, as in the second embodiment, the strong seal portion 16 seals the first sheet-like member 11 and the second sheet-like member 13A along the outer edge of the container body 10A, as shown in Figure 17, outside the weak seal portion 15A, as shown in Figure 18.

[0107] In plan view, the sealing portion 17A of the second embodiment is formed in a U-shaped portion that is located away from the three-dimensional storage portion 112 and that opens on the side where the liquid introduction tube 20 in the Y direction is disposed, whereas in the third embodiment, as shown in Fig. 18, the sealing portion 17A is formed along the outer edge of the three-dimensional storage portion 112. In plan view, the sealing portion 17A is formed at least partially at the position where the heat-resistant sheet-like member 12A is disposed.

[0108] In the third embodiment, when the cryopreservation container 1A is opened and removed, the frozen cryopreservation container 1A is first thawed. Then, as shown in Figures 17 and 18, the outer peripheral edge 19A (the end portion 11b of the first sheet-like member 11, the end portion 13b of the second sheet-like member 13A, and the end portion 14b of the third sheet-like member 14) of the container body 10A, including the portion where the strong seal portion 16 is formed, is cut off with a cutting tool such as scissors.

[0109] Next, in the same manner as the procedure shown in the lower diagram of FIG. 15 for the second embodiment, after the outer peripheral edge 19A is cut off, the first sheet-like member 11 and the second sheet-like member 13A are pulled away from each other in the Z direction toward one side Z1 and the other side Z2, and the first sheet-like member 11 and the second sheet-like member 13A are peeled away from each other at the weak seal portion 15A. The weak seal portion 15A has a seal strength sufficient to prevent leakage of the cryoprotectant 103 injected into the three-dimensional storage portion 112 and is heat-sealed to a seal strength that allows manual opening. Therefore, the first sheet-like member 11 and the second sheet-like member 13A can be easily peeled away from each other at the weak seal portion 15A. Then, the heat-resistant sheet member 12A disposed between the first sheet-like member 11 and the second sheet-like member 13A is removed.

[0110] This allows the container body 10A to be opened and the cell sheet 101 contained in the three-dimensional containing section 112 to be removed. Before cutting the outer peripheral edge 19A including the strong seal section 16, the outer peripheral edge is sealed by the strong seal section 16, and after removing the strong seal section 16, the first sheet-like member 11 and the second sheet-like member 13A can be peeled apart and opened at the weak seal section 15A. This prevents contamination of the cell sheet 101 contained in the three-dimensional containing section 112.

[0111] The third embodiment can also achieve the same effects as the second embodiment.

[0112] Next, a cryopreservation container 1B of a fourth embodiment will be described. As shown in Figures 19 and 20, the cryopreservation container 1B of the fourth embodiment differs from the cryopreservation container 1 of the second embodiment mainly in the position at which the heat-resistant sheet member 12B is stacked and in the two sheet members sealed in the weak seal portion 15B, the strong seal portion 16B, and the sealing seal portion 17B. In the fourth embodiment, components similar to those of the second embodiment are designated by the same reference numerals and will not be described again.

[0113] 19 and 20 , the container body 10B includes a first sheet-like member 11, a second sheet-like member 13B, a heat-resistant sheet-like member 12B, a third sheet-like member 14, a weak seal portion 15B, a strong seal portion 16B, and a sealing seal portion 17B. The first sheet-like member 11, the second sheet-like member 13B, the heat-resistant sheet-like member 12B, and the third sheet-like member 14 are stacked in this order from one side Z1 to the other side Z2 in the Z direction.

[0114] The position where the heat-resistant sheet member 12B in the fourth embodiment is stacked is different from the position where the heat-resistant sheet member 12 in the second embodiment is stacked. In the second embodiment, the heat-resistant sheet member 12 is placed between the first sheet member 11 and the second sheet member 13, whereas in the fourth embodiment, the heat-resistant sheet member 12B is placed between the second sheet member 13B and the third sheet member 14, as shown in FIG.

[0115] The first sheet-like member 11, the second sheet-like member 13B, the heat-resistant sheet-like member 12B and the third sheet-like member 14 differ from the second embodiment in the layer on which the heat-resistant sheet-like member 12B is arranged, but when viewed in a plane, they are all formed to the same size and shape and are arranged in the same position.

[0116] 19 and 20 , the heat-resistant sheet member 12B is disposed between the second sheet member 13B and the third sheet member 14 at a position where the weak seal portions 15B and the strong seal portions 16B are not formed in plan view and where the weak seal portions 15B and the strong seal portions 16B are avoided. The heat-resistant sheet member 12B is formed in a U-shape in plan view at a position away from the three-dimensional storage section 112, with the side where the liquid introduction tube 20 is disposed in the Y direction being open.

[0117] The weak seal portion 15B is formed by sealing the second sheet-like member 13B and the third sheet-like member 14 together at the same position and in the same area as the weak seal portion 15 of the second embodiment in a plan view, as shown in Fig. 19. The strong seal portion 16B is formed by sealing the second sheet-like member 13B and the third sheet-like member 14 together at the same position and in the same area as the strong seal portion 16 of the second embodiment in a plan view, as shown in Fig. 19.

[0118] The sealing portion 17B is formed by sealing the first sheet-like member 11 and the second sheet-like member 13B together as shown in Fig. 19 in the same position and in the same area as the sealing portion 17 of the second embodiment in plan view. The sealing portion 17B is formed in the position where the heat-resistant sheet-like member 12B is arranged in plan view.

[0119] In the fourth embodiment, to open and remove the cryopreservation container 1B, the frozen cryopreservation container 1B is first thawed. Next, as shown in Figures 19 and 20, the outer peripheral edge 19B (the end portion 11c of the first sheet-like member 11, the end portion 13c of the second sheet-like member 13B, and the end portion 14c of the third sheet-like member 14) of the container body 10B, including the portion where the strong seal portion 16B is formed, is cut with a cutting tool such as scissors. Then, the heat-resistant sheet member 12B disposed between the second sheet-like member 13B and the third sheet-like member 14 is removed.

[0120] 15 of the second embodiment, after the outer peripheral edge 19B is cut off, the second sheet-like member 13B and the third sheet-like member 14 are pulled to one side Z1 and the other side Z2 in the Z direction so as to separate them, and the second sheet-like member 13B and the third sheet-like member 14 are peeled apart at the weak seal portion 15B to open the container body 10B. The weak seal portion 15B has a seal strength sufficient to prevent leakage of the cryoprotectant 103 injected into the three-dimensional storage portion 112 to the outside, and is a heat-sealed seal portion with a seal strength sufficient for manual opening by a person, so that the second sheet-like member 13B and the third sheet-like member 14 can be easily peeled apart at the weak seal portion 15B.

[0121] This allows the container body 10B to be opened and the cell sheet 101 contained in the three-dimensional containing section 112 to be removed. Before cutting the outer peripheral edge 19B including the strong seal section 16B, the outer peripheral edge is sealed by the strong seal section 16B, and after removing the strong seal section 16B, the second sheet-like member 13B and the third sheet-like member 14 can be peeled apart and opened at the weak seal section 15B. This prevents contamination of the cell sheet 101 contained in the three-dimensional containing section 112.

[0122] The fourth embodiment can also achieve the same effects as the second embodiment.

[0123] Although the embodiments of the present invention have been described above, the present invention is not limited to the embodiments and can be embodied in various forms without departing from the spirit of the present invention. The present invention includes the following combinations.

[0124] <1> A medical container for medical use, comprising: a first sheet-like member having a storage portion; a second sheet-like member laminated on the first sheet-like member, the second sheet-like member having an opening hole in a portion corresponding to the storage portion; a third sheet-like member laminated on the second sheet-like member on the side opposite the first sheet-like member, and formed to cover the storage portion; a first seal portion in which the first sheet-like member and the second sheet-like member, or the second sheet-like member and the third sheet-like member, are joined and sealed with a seal strength that allows them to be opened by hand; and a non-welded region member, which is disposed between the same two sheet-like members as the two sheet-like members sealed by the first seal portion, in a circumferential direction of the storage portion avoiding the first seal portion in a plan view, and has a non-welded region member opening hole in a portion corresponding to the storage portion. <2> The medical container according to <1>, wherein two of the first and second sheet-like members, or the second and third sheet-like members, that are not sealed by the first seal portion are provided with a second seal portion that is heat-sealed with a seal strength stronger than that of the first seal portion at a portion where the two sheet-like members, out of the first and second sheet-like members or the second and third sheet-like members, are laminated on the non-weld region member. <3> The medical container according to <1> or <2>, wherein the storage portion is formed by three-dimensional molding. <4> The medical container according to any one of <1> to <3>, wherein a third seal portion is provided between the first and second sheet-like members so as to surround the first seal portion and the non-weld region member. <5> The medical container according to any one of <1> to <4>, wherein a tube that can introduce a protective agent from outside into the storage portion is provided on one side of the medical container between the first and second sheet-like members, between the second and third sheet-like members, or between the first and third sheet-like members. <6> The medical container according to <5>, wherein the first sheet-shaped member and the second sheet-shaped member, the second sheet-shaped member and the third sheet-shaped member, or the first sheet-shaped member and the third sheet-shaped member are sealed with a seal strength stronger than that of the first seal portion on only one side of the medical container that includes the tube.<7> The medical container according to <5>, which has a third seal portion sealed between the first sheet-like member and the second sheet-like member so as to surround the first seal portion and the non-welded region member, and the first seal portion and the third seal portion each form a U-shaped seal in a plan view on three sides of the medical container where the tube is not positioned. <8> The medical container according to <6>, in which the non-welded region member has an opening hole only on one side of the medical container where the tube is sealed. <9> The medical container according to <3>, in which the storage section is formed into a rectangular cross-sectional shape extending in a predetermined direction. <10> The medical container according to any one of <1> to <9>, which is used for cryopreservation. <11> The medical container according to <4>, in which the first sheet-like member, the second sheet-like member, and the third sheet-like member have marks that serve as guides for cutting when removing the contents.

[0125] Although the preferred embodiments of the cryopreservation container of the present invention have been described above, the present invention is not limited to the above-described embodiments and can be modified as appropriate.

[0126] For example, in the first embodiment, the weak seal portion 55 (first seal portion) and the strong seal portion 56 (second seal portion) are provided on one side of the end portion of one side D2a in the D2 direction of the cryopreservation container 5, but this is not limited to this. The weak seal portion 55 (first seal portion) and the strong seal portion 56 (second seal portion) may also be provided on other sides of the cryopreservation container 5, or may be provided on multiple sides.

[0127] In the first embodiment, a space is provided between the weak seal portion 55 (first seal portion) and the strong seal portion 56 (second seal portion) to make it easier to separate the outer edge portion 59, but this is not limiting. It is not necessary to provide a space between the weak seal portion 55 (first seal portion) and the strong seal portion 56 (second seal portion).

[0128] In the first embodiment, the first sheet-like portion 51 and the second sheet-like portion 52 are formed by a sheet-like portion 53 formed by continuously forming the first sheet-like portion 51 and the second sheet-like portion 52, and are folded back in an arc at the end on one side D1a in the D1 direction, but this is not limited to this. The first sheet-like portion 51 and the second sheet-like portion 52 may be formed by separate sheet-like portions, and the end on one side D1a in the D1 direction may be sealed with a seal portion.

[0129] In the first embodiment, the cryopreservation container 5 is provided with a liquid introduction tube 60 through which a cryoprotectant liquid can be introduced, and in the second embodiment, the cryopreservation container 1 is provided with liquid introduction tubes 60, 20 through which a cryoprotectant liquid can be introduced. However, this is not limited to this. In the first and second embodiments, all four sides may be sealed with sealing portions without providing the liquid introduction tubes 60, 20.

[0130] In the second to fourth embodiments, a three-dimensional storage section 112 is provided as the storage section, but this is not limiting. Instead of providing a three-dimensional storage section in the first sheet-shaped member 11, the first sheet-shaped member 11 may be formed into a flat shape, and the portion between the first sheet-shaped member 11 and the third sheet-shaped member 14 may be used as the storage section. In this case, the storage section may store, for example, a liquid biological sample containing cells.

[0131] In the second to fourth embodiments, the three-dimensional storage section 112 has a circular shape in plan view, but this is not limiting. For example, the three-dimensional storage section 112 may have a rectangular, elliptical, or polygonal shape in plan view. Furthermore, the cross-sectional shape of the three-dimensional storage section 112 is rectangular, but this is not limiting. For example, the cross-sectional shape of the three-dimensional storage section 112 may have a circular, elliptical, or polygonal shape.

[0132] In the second to fourth embodiments, the medical container is a cryopreservation container that can be stored in a frozen state, but this is not limiting. For example, the medical container may be a container that can be transported and stored in a refrigerated state or at room temperature.

[0133] In the second to fourth embodiments, the medical container is configured as a cryopreservation container that can be stored in a frozen state, and the storage section is filled with a cryoprotective liquid for cryopreservation, but this is not limited to this. If the medical container is configured as a container that can be transported and stored in a refrigerated state or at room temperature, the storage section does not need to be filled with a cryoprotective liquid, and gas may be present in the storage section.

[0134] 5 Cryopreservation container (medical container) 51 First sheet-like portion 52 Second sheet-like portion 54 Storage portion 55 Weak seal portion (first seal portion) 56 Strong seal portion (second seal portion) 57 First sealing seal portion (third seal portion) 58 Second sealing seal portion (fourth seal portion) 1, 1A, 1B Cryopreservation container (medical container) 11 First sheet-like member 12, 12A, 12B Heat-resistant sheet-like member (non-welded region member) 13, 13A, 13B Second sheet-like member 14 Third sheet-like member 15, 15A, 15B Weak seal portion (first seal portion) 16, 16B Strong seal portion (third seal portion) 17, 17A, 17B Sealing seal portion (second seal portion) 20 Liquid introduction tube (tube) 103 Cryoprotective liquid (protective agent) 112 Three-dimensional storage section (storage section) 115 Mark 131 Opening hole (opening hole in second sheet-like member) 121 Opening hole (opening hole in non-welded region member)

Claims

1. A medical container comprising: a first sheet-like portion; a second sheet-like portion arranged to overlap the first sheet-like portion and forming a storage portion between the first sheet-like portion and the second sheet-like portion; a first sealed portion formed on the outside of the storage portion in the first sheet-like portion and the second sheet-like portion, where the first sheet-like portion and the second sheet-like portion are heat-sealed; and a second sealed portion formed on the outside of the first sealed portion with respect to the storage portion in the first sheet-like portion and the second sheet-like portion, where the first sheet-like portion and the second sheet-like portion are heat-sealed with a seal strength stronger than that of the first sealed portion.

2. A medical container as described in claim 1, comprising a third seal portion formed on the outer edges of the first sheet-like portion and the second sheet-like portion where the first seal portion and the second seal portion are not provided, and sealed by heat with a seal strength stronger than that of the first seal portion.

3. A medical container for medical use comprising: a first sheet-like member having a storage portion; a second sheet-like member laminated on the first sheet-like member and having a second sheet-like member opening hole in a portion corresponding to the storage portion; a third sheet-like member laminated on the side of the second sheet-like member opposite the first sheet-like member and formed so as to cover the storage portion; a first seal portion in which the first sheet-like member and the second sheet-like member, or the second sheet-like member and the third sheet-like member, are joined and sealed with a seal strength that allows them to be opened by hand; and a non-welded region member arranged between the same two sheet-like members as the two sheet-like members sealed by the first seal portion, in the outer circumferential direction of the storage portion avoiding the first seal portion in a plan view, and having a non-welded region member opening hole in a portion corresponding to the storage portion.

4. A medical container as described in claim 3, wherein two of the first sheet-like member and the second sheet-like member, or the second sheet-like member and the third sheet-like member that are not sealed by the first seal portion are provided with a second seal portion that is heat-sealed with a seal strength stronger than that of the first seal portion at the portion where the two sheet-like members are laminated to the non-welded area member.

5. The medical container according to claim 3 or 4, wherein the storage section is formed by three-dimensional molding.

6. A medical container as described in claim 3 or 4, having a third seal portion sealed between the first sheet-like member and the second sheet-like member so as to surround the first seal portion and the non-welded region member.

7. A medical container as described in claim 3 or 4, further comprising a tube capable of introducing a protective agent from the outside into the storage section, disposed on one side of the medical container between the first sheet-like member and the second sheet-like member, between the second sheet-like member and the third sheet-like member, or between the first sheet-like member and the third sheet-like member.

8. A medical container as described in claim 7, wherein only one side of the medical container that has the tube is sealed with a seal strength stronger than that of the first seal portion, between the first sheet-like member and the second sheet-like member, the second sheet-like member and the third sheet-like member, or the first sheet-like member and the third sheet-like member.

9. A medical container as described in claim 7, which has a third seal portion sealed between the first sheet-like member and the second sheet-like member so as to surround the first seal portion and the non-welded region member, and both the first seal portion and the third seal portion are sealed in a U-shape in a planar view on three sides of the medical container on which the tube is not positioned.

10. The medical container according to claim 8, wherein the non-welded region member has an opening hole only on one side of the medical container where the tube is sealed.

11. The medical container according to claim 5, wherein the container portion is formed so that its cross-sectional shape is rectangular and extends in a predetermined direction.

12. The medical container according to claim 3, which is used for cryopreservation.

13. The medical container according to claim 6, wherein the first sheet-like member, the second sheet-like member and the third sheet-like member are provided with marks that serve as guides for cutting when removing the contents.

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