Medical container

Abstract

To provide a medical container capable of suppressing a biological sample stored inside from being contaminated at opening.SOLUTION: A medical container 1 includes: a first sheet-like member 11 having a storage part 112; a second sheet-like member 13 laminated on the first sheet-like member 11 and having a second sheet-like member opening hole 131; a third sheet-like member 14 laminated on an opposite side to the first sheet-like member 11 of the second sheet-like member 13 and formed so as to cover the storage part 112; a first seal part 15 where the first sheet-like member 11 and the second sheet-like member 13, or the second sheet-like member 13 and third sheet-like member 14 are joined with seal strength permitting opening with the hands, and sealed; and a non-deposition area member 12 arranged between two sheet-like members the same as the two sheet-like members sealed by the first seal part 15 in an outer peripheral direction of the storage part 112 avoiding the first seal part 15 in a plane view, and having a non-deposition area member opening hole 121 in a part corresponding to the storage part 112.SELECTED DRAWING: Figure 5

Description

[Technical field]

[0001] The present invention relates to a medical container for medical use. [Background technology]

[0002] Conventionally, there is known a medical container in which an opening communicating with a container body is sealed by heat welding (see, for example, Patent Document 1). The medical container contains cells or a sample in which cells are attached to a structure or member made from cells, and the medical container is frozen and stored. The medical container described in Patent Document 1 is opened by cutting the opening part with a cutting tool. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] JP 2007-302567 A Summary of the Invention [Problem to be solved by the invention]

[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. As a result, biological samples such as cells contained in the medical container may be contaminated 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. [Means for solving the problem]

[0006] 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 side of the second sheet-like member opposite the first sheet-like member and formed so as to cover the storage portion; a first sealed 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 sealing strength that allows them to be opened by hand; and a non-welded region member that is disposed between the same two sheet-like members as the two sheet-like members sealed by the first sealed portion in the outer circumferential direction of the storage portion avoiding the first sealed portion in a plan view, and has a non-welded region member opening hole in a portion corresponding to the storage portion.

[0007] It is also 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, are provided with a second sealing portion that is heat-sealed with a sealing strength stronger than that of the first sealing portion in the portion laminated to the non-welded area member.

[0008] Moreover, it is preferable that the housing portion is formed by three-dimensional molding.

[0009] 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.

[0010] 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, capable of introducing a protective agent from the outside into the storage section.

[0011] It is also preferable that only one side of the medical container that has the tube, 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, are sealed with a sealing strength stronger than that of the first seal portion.

[0012] 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 so as to surround the first seal portion and the non-welded area 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.

[0013] Moreover, it is preferable that the non-welded region member has an opening hole only on one side of the medical container where the tube is sealed.

[0014] It is also preferable that the container portion is formed so that its cross-sectional shape is rectangular and extends in a predetermined direction.

[0015] Moreover, the medical container is preferably used for cryopreservation.

[0016] Moreover, it is preferable that 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. Effect of the Invention

[0017] According to the present invention, it is possible to provide a medical container that can prevent contamination of a biological sample contained therein when the container is opened. [Brief description of the drawings]

[0018] [Figure 1] 1 is a perspective view of a cryopreservation container according to a first embodiment of the present invention, viewed obliquely from above. [Diagram 2] FIG. 2 is a perspective view of the cryopreservation container according to the first embodiment, seen obliquely from below. [Diagram 3] FIG. 2 is a plan view of the cryopreservation container according to the first embodiment. [Figure 4] FIG. 2 is an exploded perspective view of the cryopreservation container according to the first embodiment. [Diagram 5] FIG. 2 is a schematic cross-sectional view taken along line AA in FIG. [Figure 6] FIG. 2 is a schematic cross-sectional view taken along line BB in FIG. [Figure 7] FIG. 2 is a plan view of the cryopreservation container according to the first embodiment, showing the positions of each sealing portion. [Figure 8] 1A to 1C are cross-sectional views showing a method for producing a cryopreservation container according to the first embodiment. [Figure 9] FIG. 2 is a plan view showing a method for producing a cryopreservation container according to the first embodiment. [Figure 10] 3A to 3C are cross-sectional views showing a method of using the cryopreservation container according to the first embodiment. [Figure 11] FIG. 2 is a plan view showing a method of using the cryopreservation container according to the first embodiment. [Figure 12] FIG. 6 is a cross-sectional view of a cryopreservation container according to a second embodiment. [Figure 13] FIG. 11 is a plan view of a cryopreservation container according to a second embodiment. [Figure 14] FIG. 11 is a cross-sectional view of a cryopreservation container according to a third embodiment. [Figure 15] FIG. 11 is a plan view of a cryopreservation container according to a third embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] Hereinafter, preferred embodiments of the cryopreservation container 1 as a medical container of the present invention will be described with reference to the drawings. The cryopreservation container 1 of the present invention is used in medical treatment to cryopreserve biological samples such as cell sheets and other cells.

[0020] A cryopreservation container 1 of the first embodiment will be described with reference to Figs. 1 to 7. In the description of this embodiment, the direction in which one side of the container body 10 formed in a quadrangular shape in a plan view of the cryopreservation container 1 extends 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.

[0021] As shown in Figs. 1 to 4, the cryopreservation container 1 of the first embodiment includes a container body 10 and a liquid introduction tube 20 (tube) into which a cryoprotective liquid 103 (protective agent) (see Fig. 5) 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.

[0022] As shown in Figs. 3 to 7, the container body 10 includes 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 material sheet made of a heat-resistant fluorine material, and is preferably made of a sheet of a 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.

[0023] As shown in FIG. 4, 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 portion 18, as shown in FIGS. 5 to 7.

[0024] As shown in FIG. 4, 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 stacked in this order from one side Z1 to the other side Z2 in the Z direction. In a state in which 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 stacked, the container body 10 is formed in a substantially rectangular shape in a plan view as shown in FIG. 3, 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 between the first sheet-like member 11 and the third sheet-like member 14 on one side of the cryopreservation container 1. The liquid introduction tube 20 is capable of introducing a cryoprotectant liquid 103 (see FIG. 5) into the container body 10. In addition, the liquid introduction tube 20 may be configured to be positioned between the first sheet-like member 11 and the second sheet-like member 13 on one side of the cryopreservation container 1, or between the second sheet-like member 13 and the third sheet-like member 14.

[0025] As shown in FIG. 4, 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 generally rectangular shape in a plan view, with one side extending in the X direction and the other side extending in the Y direction.

[0026] The three-dimensional containing section 112 is formed by three-dimensional molding as shown in Figures 4 to 6. The three-dimensional containing section 112 is formed in a three-dimensional shape recessed from the containing-section-surrounding sheet-like section 111 on the inside of the containing-section-surrounding sheet-like 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.

[0027] The container body 113 is formed to have a circular shape in a plan view. As shown in Fig. 5, the container body 113 is formed to have a rectangular shape in a cross section cut along the X direction extending in the Y direction, and as shown in Fig. 6, the container body 113 is formed to have a rectangular shape in a cross section cut along the Y direction extending in the Y direction.

[0028] The three-dimensional container section 112 communicates with a liquid introduction tube 20 disposed at one end of the container body 10 in the Y direction at one side in the Y direction. In the three-dimensional container section 112, a cryoprotective liquid 103 (see FIG. 5) is introduced by the liquid introduction tube 20 in a state in which the cell sheet 101 is contained. The cell sheet 101 is formed in a sheet shape by culturing cells collected from human tissue. In this embodiment, the cell sheet 101 is formed in a disk shape with a diameter slightly smaller than the inner diameter of the three-dimensional container section 112 so as to be contained in the three-dimensional container section 112. Thereby, when the cryopreservation container 1 is frozen, the three-dimensional container section 112 is filled with the cryoprotective liquid 103 as shown in FIG. 5 in a state in which the cell sheet 101 is contained. In this embodiment, a cell sheet is described as an example of a biological sample such as cells contained in the three-dimensional container section 112, but is not limited thereto. For example, the biological sample may be a cell mass (spheroid) in which cells are aggregated together to form a mass. Furthermore, for example, a cell suspension containing cells as a biological sample may be contained in the three-dimensional containing section 112.

[0029] The heat-resistant sheet member 12 is arranged in a stacked manner 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 hole 121 (heat-resistant sheet member opening hole) in a portion corresponding to the three-dimensional storage section 112. The opening hole 121 of the heat-resistant sheet member 12 is open only on one side where the liquid introduction tube 20 of the cryopreservation container 1 is sealed. The opening hole 121 opens on the liquid introduction tube 20 side in the Y direction so as to avoid the three-dimensional storage section 112 and open in a range wider than the three-dimensional storage section 112. 5 and 7, 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 outer circumferential direction of the three-dimensional containing portion 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.

[0030] As shown in FIG. 4, the second sheet-like member 13 is arranged on the other side Z2 of the first sheet-like member 11 in the Z direction, sandwiching the heat-resistant sheet-like member 12. That is, the second sheet-like member 13 is arranged on the other side Z2 of the heat-resistant sheet-like 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 avoiding the three-dimensional storage section 112. The second sheet-like member 13 has an opening hole 131 (second sheet-like member opening hole) in a portion corresponding to the three-dimensional storage section 112. The opening hole 131 is shaped to correspond to the three-dimensional storage section 112 so as to avoid the three-dimensional storage section 112, and opens to the liquid introduction tube 20 side in the Y direction.

[0031] The third sheet-like member 14 is arranged by being stacked on the other side Z2 of the second sheet-like member 13 (the side of the second sheet-like member 13 opposite to the first sheet-like member 11) in the Z direction. The third sheet-like member 14 is formed in a planar shape having 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 containing portion 112 of the first sheet-like member 11.

[0032] As shown in Fig. 5 and Fig. 7, the weak seal portion 15, the strong seal portion 16, the sealing seal portion 17, and the liquid introduction tube side sealing 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, such as heat sealing or ultrasonic sealing. Note that the weak seal portion 15, the strong seal portion 16, the sealing seal portion 17, and the liquid introduction tube side sealing 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.

[0033] As shown in FIG. 7, 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 plan 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 arranged. The weak seal portion 15 is formed in a U-shape with the liquid introduction tube 20 side open in a plan view, and seals the first sheet-like member 11 and the second sheet-like member 13 as shown in FIG. 5 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 in which the first sheet-like member 11 and the second sheet-like member 13 are sealed by heat with a seal strength that can 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 to the outside.

[0034] As shown in FIG. 7, the strong seal portion 16 is formed on the outer periphery of the first sheet-like member 11 outside 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 where the liquid introduction tube 20 is not arranged on the outer periphery side of the weak seal portion 15. The strong seal portion 16 seals the first sheet-like member 11 and the second sheet-like member 13 at a position away from the outer edge of the U-shaped portion of the weak seal portion 15 along the outer edge of the first sheet-like member 11 and the outer edge of the second sheet-like member 13, as shown in FIG. 5, so as to surround the U-shaped portion with a predetermined width that opens to the liquid introduction tube 20 side. 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 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 it by hand.

[0035] As shown in Fig. 7, the sealing portion 17 is formed between the weak seal portion 15 and the strong seal portion 16 in plan view, and seals in a U-shape with a predetermined width that opens to the liquid introduction tube 20 side. The sealing portion 17 is formed at at least a part of the position where the heat-resistant sheet member 12 is disposed in plan view. The predetermined width of the sealing portion 17 is preferably, for example, 2 to 20 mm, and more preferably 10 to 15 mm. This prevents the sealing portion 17 from shifting and overlapping with other seal portions, and ensures reliable sealing at the sealing position.

[0036] 5, 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 that 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 so that the cryoprotectant liquid 103 injected into the three-dimensional storage portion 112 does not leak out to the outside. The sealing portion 17 has a seal strength that is difficult for a person to open by hand, and is a seal portion that 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.

[0037] 7, the liquid introduction tube side sealing part 18 seals the first sheet-like member 11 and the third sheet-like member 14 with the liquid introduction tube 20 disposed between them at the end on the liquid introduction tube 20 side in the Y direction. The liquid introduction tube side sealing part 18 seals the first sheet-like member 11 and the third sheet-like member 14 only on one side of the cryopreservation container 1 that includes the liquid introduction tube 20 with a stronger seal strength than the weak seal part 15. The liquid introduction tube side sealing part 18 is a sealing part that has a seal strength that makes it difficult for a person to open it by hand.

[0038] 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 first embodiment, the liquid introduction tube 20 is disposed between the first sheet-shaped member 11 and the second sheet-shaped member 13 such that one end side of the liquid introduction tube 20 communicates with the three-dimensional storage section 112 of the first sheet-shaped member 11. The other end side 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.

[0039] As shown in Figs. 1 to 3, 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 first sheet-like member 11, the second sheet-like member 13, and the third sheet-like member 14 that are arranged in a stacked manner along the X direction. The mark 116 is a mark for cutting the first sheet-like member 11, the second sheet-like member 13, and the third sheet-like member 14 that are arranged in a stacked manner along the Y direction. As shown in Fig. 4, the marks 115, 116 are formed by overlapping 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.

[0040] 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 to overlap 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.

[0041] 7, the pair of recessed portions 11d of the first sheet-like member 11, the pair of recessed portions 13d of the second sheet-like member 13, and the pair of recessed portions 14d of the third sheet-like member 14 are formed in a concave shape 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 extending in the X direction formed at the end opposite the side where the liquid introduction tube 20 is arranged in the Y direction of the cryopreservation container 1. The pair of recessed portions 11e of the first sheet-like member 11, the pair of recessed portions 13e of the second sheet-like member 13, and the pair of recessed portions 14e of the third sheet-like member 14 are formed inward in the X direction on the end opposite the side where the liquid introduction tube 20 is arranged in the Y direction of the strong seal portion 16 extending in the Y direction formed at both ends in the X direction of the cryopreservation container 1 in the X direction.

[0042] 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 in a concave shape that is concave 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 positioned in the Y direction of the cryopreservation container 1, thereby serving as a mark when cutting along the X direction.

[0043] 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, so that the mark 116 is formed in a concave shape recessed toward the liquid introduction tube 20 in the Y direction, on the end opposite to the side where the liquid introduction tube 20 in the Y direction is arranged, on the inside in the X direction of the strong seal portions 16 extending in the Y direction formed at both end portions in the X direction of the cryopreservation container 1 in the X direction, and serves as a mark when cutting along the Y direction.

[0044] 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.

[0045] 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 on the side opposite to the side where the liquid introduction tube 20 is disposed 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 inside in the X direction 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.

[0046] In this way, by providing the mark 115 serving 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.

[0047] 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 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 on the liquid introduction tube 20 side in the Y direction of the strong seal portion 16 extending in the X direction at the end opposite to the side where the liquid introduction tube 20 is arranged, it is possible to separate the strong seal portion 16 extending in the X direction formed at the end opposite to the side where the liquid introduction tube 20 is arranged.

[0048] 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.

[0049] Next, a method for storing a biological sample such as a cell sheet in the cryopreservation container 1 will be described. As shown in the upper diagram of Fig. 8 and the left diagram of Fig. 9, 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 in a state where only the liquid introduction tube side seal portion 18 is sealed.

[0050] After shipment from the factory, as shown in the middle diagram of Figure 8 and the left diagram of Figure 9, the first sheet-like member 11, the heat-resistant sheet-like member 12 and the second sheet-like member 13 are stacked and arranged in the cryopreservation container 1, and are sealed at the weak seal portion 15 and the strong seal portion 16. In this state, the user places the cell sheet 101 in the three-dimensional storage portion 112.

[0051] Next, as shown in the middle and bottom diagrams of Figure 8, 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 laminated to the heat-resistant sheet-like member 12.

[0052] In this case, since the heat-resistant sheet-like member 12 is arranged on one side Z1 of the second sheet-like member 13 and the third sheet-like member 14, the first sheet-like member 11 does not melt due to heat, and the second sheet-like member 13 and the third sheet-like member 14 are sealed together.

[0053] 8, a cryoprotectant liquid 103 is introduced into the three-dimensional container 112 by the liquid introduction tube 20, and the opening of the liquid introduction tube 20 is sealed. In this way, the user can contain 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 frozen and preserved.

[0054] Next, a method for opening the cryopreservation container 1 of the first embodiment will be described. When opening the cryopreservation container 1 to take out 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.

[0055] Next, as shown in the upper and middle diagrams of Figure 10 and Figure 11, 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.

[0056] 11, the first sheet-like member 11, the second sheet-like member 13, and the third sheet-like member 14 are cut along the X direction from the mark 115, thereby cutting off 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 disposed in the Y direction. Then, at both ends in the X direction, the first sheet-like member 11, the second sheet-like member 13, and the third sheet-like member 14 are cut along the Y direction on the inside in the X direction of the strong seal portion 16 extending in the Y direction, thereby cutting off the strong seal portion 16 extending in the Y direction formed at both ends in the X direction of the cryopreservation container 1.

[0057] 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. 10, the first sheet member 11 and the second sheet member 13 are pulled to one side Z1 and the other side Z2 in the Z direction at the outer edges thereof 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 off at the weak seal portion 15 to open the container body 10. 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, has a seal strength weaker than that of the sealing seal portion 17, and is a seal portion that is heat-sealed with a seal strength that can be opened by hand by a person, and the second sheet member 13 is strongly sealed to the third sheet member 14 side, so that the first sheet member 11 and the second sheet member 13 can be easily peeled off at the weak seal portion 15.

[0058] 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 cutting the outer periphery 19 including the strong seal section 16, the outer periphery 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 13 can be peeled away from each other to open the container at the weak seal section 15. This prevents the cell sheet 101 contained in the three-dimensional containing section 112 from being contaminated.

[0059] The cryopreservation container 1 of the first embodiment described above provides the following advantages.

[0060] (1) 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 the first sheet-like member 11 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 by 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 plan view, and having an opening hole 121 in a portion corresponding to the three-dimensional storage section 112.

[0061] 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 the container, by storing 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. Thereafter, the stack of the first sheet-like member 11, the heat-resistant sheet-like member 12, and the second sheet-like member 13 is sealed to the third sheet-like member 14, thereby hermetically sealing the cryopreservation container 1 containing the biological sample.

[0062] (2) The cryopreservation container 1 is configured to have a sealing portion 17 that is heat-sealed with a sealing strength stronger than that of 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.

[0063] 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 layered on the heat-resistant sheet-like member 12, so that the stored biological sample can be stored aseptically and can be removed aseptically without the user having to finely adjust the seal strength. The cryopreservation container 1 can be used easily. When opening the cryopreservation container 1, the outer peripheral edge portion 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 off at the weak seal portion 15 to open the container body 10. Therefore, before cutting the outer peripheral edge portion 19 including the strong seal portion 16, the outer peripheral edge 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 are peeled off and the container body 10 can be opened at the weak seal portion 15. Therefore, contamination of the cell sheet 101 contained in the three-dimensional containing portion 112 can be suppressed.

[0064] (3) The three-dimensional container section 112 is formed by three-dimensional molding, which allows a biological sample such as a cell sheet to be easily contained in the three-dimensional container section 112.

[0065] (4) Between the first sheet-like member 11 and the second sheet-like member 13, there is a strong seal portion 16 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 circumferential side of the weak seal portion 15, the airtightness of the three-dimensional storage section 112 can be improved.

[0066] (5) 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-like member 11 and the third sheet-like member 14. This makes it possible to easily introduce the cryoprotective liquid 103 for protecting a biological sample such as a cell sheet into the three-dimensional storage section 112.

[0067] (6) 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, improving breakage resistance.

[0068] (7) Between the first sheet-like member 11 and the second sheet-like member 13, there are weakly sealed portions 15 and strongly sealed portions 16 sealed to surround the heat-resistant sheet-like member 12, and the weakly sealed portions 15 and strong sealed portions 16 seal three sides of the cryopreservation container 1 where the liquid introduction tube 20 is not disposed in a U-shape in plan view. This allows a biological sample such as a cell sheet to be easily removed from the cryopreservation container 1 by cutting the cryopreservation container 1 along the three sides.

[0069] (8) The heat-resistant sheet-like 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-like member 12 disposed between the first sheet-like member 11 and the second sheet-like member 13 to be easily removed.

[0070] (9) 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.

[0071] (10) The cryopreservation container 1 is used for cryopreservation. Therefore, a medical container can be used as the cryopreservation container 1.

[0072] (11) 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 makes it possible to easily remove a biological sample such as a cell sheet 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.

[0073] Next, a cryopreservation container 1A of the second embodiment will be described. As shown in Fig. 12 and Fig. 13, in the cryopreservation container 1A of the second embodiment, the first sheet-like member 11, the heat-resistant sheet-like 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 first embodiment, but compared with the cryopreservation container 1 of the first embodiment, the second embodiment is mainly different 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-like member 12A in a plan view. In the second embodiment, the same components as those of the first embodiment are denoted by the same reference numerals and will not be described.

[0074] 12 and 13, the container body 10A includes a first sheet-like member 11, a heat-resistant sheet-like 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. 12, the first sheet-like member 11, the heat-resistant sheet-like 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, similarly to the first embodiment.

[0075] In the second 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. 13, whereas the heat-resistant sheet member 12 in the first embodiment is disposed away from the three-dimensional storage section 112 in plan view. The heat-resistant sheet member 12A is formed in a U-shape that opens on the side where the liquid introduction tube 20 in the Y direction is disposed. The heat-resistant sheet member 12A has an opening hole 121A (heat-resistant sheet member opening hole) in a portion corresponding to the three-dimensional storage section 112. The opening hole 121A has a shape corresponding to the three-dimensional storage section 112 so as to avoid the three-dimensional storage section 112, and opens on the liquid introduction tube 20 side in the Y direction.

[0076] In plan view, the weak seal portion 15A of the first embodiment is formed along the outer edge of the three-dimensional storage section 112, whereas in the second 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 12.

[0077] As in the first embodiment, in a plan view, 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 FIG. 12, outside the weak seal portion 15A, as shown in FIG. 13.

[0078] In the first embodiment, the sealing portion 17A is formed in a U-shaped portion that is open on the side where the liquid introduction tube 20 in the Y direction is disposed, away from the three-dimensional storage portion 112 in plan view, whereas in the second embodiment, the sealing portion 17A is formed along the outer edge of the three-dimensional storage portion 112 as shown in Fig. 13. The sealing portion 17A is formed in at least a part of the position where the heat-resistant sheet-like member 12A is disposed in plan view.

[0079] In the second embodiment, when the cryopreservation container 1A is opened and removed, the frozen cryopreservation container 1A is first thawed. Then, as shown in Fig. 12 and Fig. 13, the outer peripheral edge portion 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) including the portion where the strong seal portion 16 of the container body 10A is formed is cut off with a cutting tool such as scissors.

[0080] 12, after the outer peripheral edge portion 19A is cut off, the first sheet-like member 11 and the second sheet-like member 13A are pulled to one side Z1 and the other side Z2 in the Z direction so that they are separated from each other, and the first sheet-like member 11 and the second sheet-like member 13A are peeled off at the weak seal portion 15A. The weak seal portion 15A has a seal strength that prevents the cryoprotectant liquid 103 injected into the three-dimensional storage portion 112 from leaking out, and is a seal portion sealed by heat with a seal strength that can be opened by hand, so that the first sheet-like member 11 and the second sheet-like member 13A can be easily peeled off at the weak seal portion 15A. Then, the heat-resistant sheet member 12A arranged between the first sheet-like member 11 and the second sheet-like member 13A is taken out.

[0081] 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 periphery 19A including the strong seal section 16, the outer periphery 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 away and the container can be opened at the weak seal section 15A. This prevents the cell sheet 101 contained in the three-dimensional containing section 112 from being contaminated.

[0082] The second embodiment can also achieve the same effects as the first embodiment.

[0083] Next, a cryopreservation container 1B of the third embodiment will be described. As shown in Fig. 14 and Fig. 15, the cryopreservation container 1B of the third embodiment differs from the cryopreservation container 1 of the first embodiment in that the position where the heat-resistant sheet member 12B is laminated is different, and the two sheet members sealed in the weak seal portion 15B, the strong seal portion 16B, and the sealing seal portion 17B are different. In the third embodiment, the same components as those of the first embodiment are denoted by the same reference numerals, and the description thereof will be omitted.

[0084] 14 and 15, 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.

[0085] The position where the heat-resistant sheet member 12B in the third embodiment is laminated is different from the position where the heat-resistant sheet member 12 in the first embodiment is laminated. In the first embodiment, the heat-resistant sheet member 12 is disposed between the first sheet-like member 11 and the second sheet-like member 13, whereas in the third embodiment, the heat-resistant sheet member 12B is disposed between the second sheet-like member 13B and the third sheet-like member 14, as shown in FIG.

[0086] 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 first embodiment in the layer in 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 arranged in the same position.

[0087] 14 and 15, 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 parts 15B and the strong seal parts 16B are not formed in plan view and where the weak seal parts 15B and the strong seal parts 16B are avoided. The heat-resistant sheet member 12B is formed in a U-shape in plan view away from the three-dimensional accommodation section 112, with the side where the liquid introduction tube 20 is disposed in the Y direction being open.

[0088] The weak seal portion 15B is formed by sealing the second sheet-like member 13B and the third sheet-like member 14 together as shown in FIG. 14 in the same position and in the same area as the weak seal portion 15 of the first embodiment in plan view. The strong sealed portion 16B is formed by sealing the second sheet-like member 13B and the third sheet-like member 14 together as shown in FIG. 14 in the same position and in the same area as the strong sealed portion 16 of the first embodiment in plan view.

[0089] 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. 14 in the same position and in the same area as the sealing portion 17 of the first embodiment in plan view. The sealing portion 17B is formed at the position where the heat-resistant sheet-like member 12B is disposed in plan view.

[0090] In the third embodiment, when the cryopreservation container 1B is opened and taken out, the frozen cryopreservation container 1B is first thawed. Then, as shown in Fig. 14 and Fig. 15, the outer peripheral edge portion 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) including the portion where the strong seal portion 16B of the container body 10B is formed is cut off with a cutting tool such as scissors. Then, the heat-resistant sheet-like member 12B arranged between the second sheet-like member 13B and the third sheet-like member 14 is taken out.

[0091] 10 in the first embodiment, the outer peripheral edge portion 19B is cut off, and then 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 from each other, and the second sheet-like member 13B and the third sheet-like member 14 are peeled off at the weak seal portion 15B to open the container body 10B. The weak seal portion 15B has a seal strength that prevents the cryoprotectant 103 injected into the three-dimensional storage portion 112 from leaking out, and is a seal portion that is heat-sealed with a seal strength that can be opened by hand, so that the second sheet-like member 13B and the third sheet-like member 14 can be easily peeled off at the weak seal portion 15B.

[0092] 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 periphery 19B including the strong seal portion 16B, the outer periphery is sealed by the strong seal portion 16B, and after removing the strong seal portion 16B, the second sheet-like member 13B and the third sheet-like member 14 can be peeled away and the container can be opened at the weak seal portion 15B. This prevents the cell sheet 101 contained in the three-dimensional containing section 112 from being contaminated.

[0093] The third embodiment can also achieve the same effects as the first embodiment.

[0094] 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. For example, in the first to third embodiments, the three-dimensional storage section 112 is provided as the storage section, but this is not limited thereto. Instead of providing a three-dimensional storage section in the first sheet-like member 11, the first sheet-like member 11 may be formed in a planar shape, and the portion between the first sheet-like member 11 and the third sheet-like 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.

[0095] In the first to third embodiments, the three-dimensional containing section 112 is formed to have a circular shape in plan view, but is not limited thereto. For example, the three-dimensional containing section 112 may be formed to have a rectangular, elliptical, or polygonal shape in plan view. In addition, the cross-sectional shape of the three-dimensional containing section 112 is formed to have a rectangular shape, but is not limited thereto. For example, the cross-sectional shape of the three-dimensional containing section 112 may be formed to have a circular, elliptical, or polygonal shape.

[0096] In the first to third embodiments, the medical container is a cryopreservation container capable of preserving in a frozen state, but this is not limiting. For example, the medical container may be a container capable of being transported and preserved in a refrigerated state or at room temperature.

[0097] In the first to third embodiments, the medical container is configured as a cryopreservation container capable of storing the medical container in a frozen state, and the container is filled with a cryoprotective liquid for cryopreservation, but this is not limited to the above. If the medical container is configured as a container capable of being transported and stored in a refrigerated state or at room temperature, the container does not need to be filled with a protective liquid, and gas may be present in the container. [Explanation of symbols]

[0098] 1, 1A, 1B Cryopreservation container (medical container) 11 First sheet-like member 12, 12A, 12B Heat-resistant sheet-like member (non-welded area member) 13, 13A, 13B Second sheet-like member 14 Third sheet member 15, 15A, 15B Weak seal part (first seal part) 16,16B Strong seal part (third seal part) 17, 17A, 17B Sealing part (second sealing part) 20 Liquid introduction tube (tube) 103 Cryoprotectant (protective agent) 112 Three-dimensional storage section (storage section) 115 Landmark 131 Opening hole (opening hole of second sheet-like member) 121 Opening hole (non-welding area member opening hole)

Claims

1. A medical container for medical use, 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 opposite side to 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 the member to be opened by hand; a non-welded region member that is disposed between the two sheet-like members that are the same 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 planar view, and has a non-welded region member opening hole in a portion corresponding to the storage portion.

2. 2. The medical container according to claim 1, 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 in a portion where the two sheet-like members are stacked on the non-welded area member.

3. The medical container according to claim 1 , wherein the storage portion is formed by three-dimensional molding.

4. The medical container according to claim 1 or 2, further comprising 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.

5. 3. The medical container according to claim 1 or 2, further comprising a tube capable of introducing a protective agent from the outside into the storage section, the tube being 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.

6. 6. The medical container according to claim 5, 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, 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.

7. a third seal portion that is 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; The medical container according to claim 5 , wherein the first seal portion and the third seal portion each seal three sides of the medical container on which the tube is not disposed in a U-shape in a plan view.

8. 7. The medical container according to claim 6, wherein 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 claim 3 , wherein the container portion is formed into a shape having a rectangular cross-sectional shape extending in a predetermined direction.

10. The medical container according to claim 1 , which is used for cryopreservation.

11. 5. The medical container according to claim 4, 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.

Images