Medical container
The heat-sealing design of multi-layer sheet components solves the problem of contamination when medical containers are opened, and enables the safe preservation of biological samples.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- JMS CO LTD
- Filing Date
- 2024-08-28
- Publication Date
- 2026-04-21
AI Technical Summary
Existing medical containers are susceptible to bacterial contamination upon opening, posing a risk of contaminating biological samples.
It adopts a multi-layer sheet component design and forms a multi-layer sealing structure through heat sealing, including a weak sealing part, a strong sealing part and a closed sealing part, to ensure that the risk of contamination is reduced when opening.
It effectively inhibits contamination of biological samples during the opening process, ensuring the safety and purity of biological samples.
Smart Images

Figure CN121909010A_ABST
Abstract
Description
Technical Field
[0001] This invention relates to medical containers used in medicine. Background Technology
[0002] Conventionally, medical containers are known to have openings connected to the main body that are sealed by heat fusion (see, for example, Patent Document 1). These medical containers contain biological samples such as cells and are cryopreserved. The medical container described in Patent Document 1 is opened by cutting off the opening portion with a cutting tool. Existing technical documents Patent documents
[0003] Patent Document 1: Japanese Patent Application Publication No. 2007-302567 Summary of the Invention The problem the invention aims to solve
[0004] When the medical container described in Patent Document 1 is opened by cutting off the opening portion with a cutting tool, bacteria or the like may enter the interior of the medical container through the cutting tool. As a result, biological samples such as cells contained in the medical container may be contaminated by bacteria or the like.
[0005] The purpose of this invention is to provide a medical container that can prevent contamination of biological samples stored inside upon opening. Solution for solving the problem
[0006] The present invention relates to a medical container comprising: a first sheet portion; a second sheet portion disposed overlapping the first sheet portion, forming a receiving portion between the second sheet portion and the first sheet portion; a first sealing portion formed outside the receiving portion of the first and second sheet portions, formed by heat sealing the first and second sheet portions; and a second sealing portion formed on the first and second sheet portions at a location on the outer side of the receiving portion relative to the receiving portion, formed by heat sealing the first and second sheet portions with a stronger sealing strength than the first sealing portion.
[0007] Additionally, preferably, it includes a third sealing portion, which is formed on the outer edges of the first sheet portion and the second sheet portion where the first sealing portion and the second sealing portion are not provided, and is formed by heat sealing with a stronger sealing strength than the first sealing portion.
[0008] This invention relates to a medical container for medical use, comprising: a first sheet member having a receiving portion; a second sheet member stacked on the first sheet member, having a second sheet member opening at a portion corresponding to the receiving portion; a third sheet member stacked on the side of the second sheet member opposite to the first sheet member, forming a structure covering the receiving portion; a first sealing portion formed by joining and sealing the first sheet member and the second sheet member, or the second sheet member and the third sheet member, with a sealing strength that can be opened by hand; and a non-welded area member disposed between the two sheet members identical to the two sheet members sealed by the first sealing portion in a direction that avoids the outer periphery of the receiving portion when viewed from above, having a non-welded area member opening at a portion corresponding to the receiving portion.
[0009] Additionally, preferably, the first sheet member and the second sheet member, or the second sheet member and the third sheet member, in the portion of the two sheet members not sealed by the first sealing portion, have a second sealing portion formed by heat sealing with a stronger sealing strength than the first sealing portion in the portion of the non-welded area member.
[0010] In addition, preferably, the storage part is formed by three-dimensional molding.
[0011] Additionally, preferably, a third sealing portion is provided between the first sheet member and the second sheet member, which is sealed in a manner that surrounds the first sealing portion and the non-welded area member.
[0012] Additionally, preferably, a tube is provided on one side of the medical container, between the first sheet member and the second sheet member, between the second sheet member and the third sheet member, or between the first sheet member and the third sheet member, for introducing a protective agent into the receiving portion from the outside.
[0013] Additionally, preferably, the first sheet member and the second sheet member, the second sheet member and the third sheet member, or the first sheet member and the third sheet member are sealed with a stronger sealing strength than the first sealing portion only on one side of the medical container where the tubing is located.
[0014] Additionally, preferably, between the first sheet member and the second sheet member, there is a third sealing portion formed by sealing the first sealing portion and the non-welded area member, wherein both the first sealing portion and the third sealing portion are U-shaped when viewed from above, representing the three sides of the medical container without the tubing.
[0015] Additionally, preferably, the non-welded area component has an opening only on one side of the tube in the medical container where the tube is sealed.
[0016] In addition, preferably, the storage portion is formed in a rectangular cross-sectional shape and extends in a predetermined direction.
[0017] Additionally, preferably, the medical container is used for cryopreservation.
[0018] Additionally, preferably, the first sheet member, the second sheet member, and the third sheet member have markings that serve as a reference for cutting when removing the contents. Invention Effects
[0019] According to the present invention, a medical container is provided that can prevent contamination of biological samples stored inside upon opening. Attached Figure Description
[0020] Figure 1 This is a perspective view of the cryopreservation container of the first embodiment of the present invention viewed from an oblique side. Figure 2 yes Figure 1 AA-line cross-section diagram. Figure 3 This is a side view showing the case where a biological sample is stored in the cryopreservation container of the first embodiment. Figure 4 This is a side view showing the opening of the cryopreservation container of the first embodiment. Figure 5 This is a cross-sectional view showing the case where the cryopreservation container of the first embodiment is opened. Figure 6 This is a perspective view of the cryopreservation container of the second embodiment of the present invention, viewed from an obliquely upward side. Figure 7 This is a perspective view of the cryopreservation container of the second embodiment, viewed from a slightly lower angle. Figure 8 This is a top view of the cryopreservation container according to the second embodiment. Figure 9 This is an exploded perspective view of the cryopreservation container of the second embodiment. Figure 10 It is shown schematically. Figure 2 The diagram shows the cross-sectional view of the BB line. Figure 11 It is shown schematically. Figure 2 The diagram shows the cross-sectional view of the CC line. Figure 12This is a top view showing the positions of each sealing part in the cryopreservation container of the second embodiment. Figure 13 This is a cross-sectional view showing the method of manufacturing the cryopreservation container according to the second embodiment. Figure 14 This is a top view showing the method of manufacturing the cryopreservation container according to the second embodiment. Figure 15 This is a cross-sectional view showing the method of using the cryopreservation container according to the second embodiment. Figure 16 This is a top view showing the method of using the cryopreservation container according to the second embodiment. Figure 17 This is a cross-sectional view of the cryopreservation container according to the third embodiment. Figure 18 This is a top view of the cryopreservation container according to the third embodiment. Figure 19 This is a cross-sectional view of the cryopreservation container according to the fourth embodiment. Figure 20 This is a top view of the cryopreservation container according to the fourth embodiment. Detailed Implementation
[0021] Hereinafter, preferred embodiments of the cryopreservation container 5, which is a medical container of the present invention, will be described with reference to the accompanying drawings. The cryopreservation container 5 of the present invention is used in medical settings for the cryopreservation of biological samples such as cell sheets and other cells.
[0022] Reference Figure 1 and Figure 2 The cryopreservation container 5 of the first embodiment will be described below. Furthermore, in this description, when viewed from the side of the cryopreservation container 5, the direction along the longitudinal edge of the container body 50 is referred to as the D1 direction, and the direction along the transverse edge of the container body 50 is referred to as the D2 direction. The D1 direction and the D2 direction are orthogonal. The stacking direction of the plurality of sheet-like portions 51, 52 of the container body 50 is referred to as the D3 direction.
[0023] like Figure 1 and Figure 2 As shown, the cryopreservation container 5 of the first embodiment includes a container body 50 and a cryoprotectant 503 into which cryoprotectant can be introduced (see reference). Figure 2The container body 50 is formed as a bag shape, with a receiving portion 54 between a first sheet-like portion 51 and a second sheet-like portion 52, and the outer edges of the first sheet-like portion 51 and the second sheet-like portion 52 are sealed. The container body 50 is rectangular (approximately square) when viewed from the side. Cell sheets 501 are received in the receiving portion 54. Cell sheets 501 are formed by culturing cells collected from human tissue. Therefore, when the cryopreservation container 1 is frozen, the receiving portion 54, with the cell sheets 501 received, remains in a state similar to... Figure 5 As shown, it is filled with cryoprotectant 503. The cryopreservation container 5 is cryopreserved while containing biological samples such as cell slices.
[0024] Furthermore, in this embodiment, cell sheets are used as an example to describe the biological sample such as cells stored in the storage section 54, but it is not limited to this. For example, the biological sample may also be a tissue sheet in which cells are formed into blocks. In addition, for example, a cell suspension containing cells as biological samples may also be stored in the storage section 54.
[0025] The container body 50 is configured such that the sheet portion 53, on one side (D1a) of the D1 direction, where the first sheet portion 51 and the second sheet portion 52 are continuously formed, is folded back into an arc shape at one end and overlaps with each other at the other side (D1b) of the D1 direction, thereby overlapping the first sheet portion 51 and the second sheet portion 52. The outer edges of the first sheet portion 51 and the second sheet portion 52, other than the portion of the sheet portion 53 that is folded back into an arc shape, are sealed.
[0026] The first sheet portion 51, the second sheet portion 52, and the liquid inlet tube 60 are made of flexible thermoplastic resins such as EVA resin (ethylene-vinyl acetate copolymer resin). The first sheet portion 51, the second sheet portion 52, and the liquid inlet tube 60 are made of a freeze-resistant material to enable freezing.
[0027] like Figure 1 As shown, the first sheet portion 51 and the second sheet portion 52 are joined together in a weak sealing portion 55 (first sealing portion), a strong sealing portion 56 (second sealing portion), a first closed sealing portion 57 (third sealing portion), and a second closed sealing portion 58 (third sealing portion). A receiving portion 54 is formed between the first sheet portion 51 and the second sheet portion 52.
[0028] The weak sealing part 55, the strong sealing part 56, the first sealing part 57, and the second sealing part 58 are sealing parts formed by joining the first sheet-like part 51 and the second sheet-like part 52 by heat sealing, ultrasonic sealing, or the like.
[0029] like Figure 1As shown, the weak sealing portion 55, when viewed from the side, is formed on the outer side of the receiving portion 54 on one side D2a of the first sheet portion 51 and the second sheet portion 52 in the D2 direction. The weak sealing portion 55, when viewed from the side, is formed as a straight line extending in the D1 direction, sealing the first sheet portion 51 and the second sheet portion 52. The weak sealing portion 55 is a sealing portion formed by heat sealing the first sheet portion 51 and the second sheet portion 52 with a sealing strength that can be opened by hand. The weak sealing portion 55 has a cryoprotectant liquid 503 injected into the receiving portion 54 (see reference). Figure 2 It has a sealing strength that prevents leakage to the outside.
[0030] The strong seal portion 56, when viewed from the side, is formed on one side D2a of the first sheet portion 51 and the second sheet portion 52 in the D2 direction, further outward than the weak seal portion 55 relative to the receiving portion 54. At a position separating it from the weak seal portion 55, the strong seal portion 56 is formed in a straight line extending in the D1 direction along the outer edges of the first sheet portion 51 and the second sheet portion 52, sealing the first sheet portion 51 and the second sheet portion 52. The strong seal portion 56 is a seal formed by heat sealing the first sheet portion 51 and the second sheet portion 52 with a sealing strength stronger than that of the weak seal portion 55. The strong seal portion 56 is a seal that prevents the cryoprotectant 503 injected into the receiving portion 54 from leaking to the outside, and has a sealing strength sufficient to prevent surrounding liquid nitrogen from penetrating the interior during freezing and to prevent it from being opened by hand.
[0031] The first sealing portion 57 and the second sealing portion 58 are formed in the outer edges of the first sheet portion 51 and the second sheet portion 52 in the portions not sealed by the weak sealing portion 55 and the strong sealing portion 56.
[0032] The first sealing portion 57 is formed in a straight line in the D1 direction from the outer edge of the end of the D2b on the other side of the D2 direction when viewed from the side, sealing the first sheet portion 51 and the second sheet portion 52. The second sealing portion 58, at its end on the D1-direction side D1a of the liquid inlet tube 60, seals the first sheet portion 51 and the second sheet portion 52 when the liquid inlet tube 60 is disposed between the first sheet portion 51 and the second sheet portion 52. When viewed from the side, the second sealing portion 58 extends linearly in the D2-direction at its end on the other side D1b of the D1-direction.
[0033] The first sealing portion 57 and the second sealing portion 58 are sealing portions that prevent the cryoprotectant 503 injected into the receiving portion 54 from leaking to the outside. The first sealing portion 57 and the second sealing portion 58 are sealing portions with a sealing strength that cannot be opened by hand and are heat-sealed with a stronger sealing strength than the weak sealing portion 55. The sealing strength of the first sealing portion 57 and the second sealing portion 58 may be the same as or different from the sealing strength of the strong sealing portion 56.
[0034] The liquid inlet tube 60 is fitted to the end of the container body 50 on the opposite side D2b in the D1 direction. The liquid inlet tube 60 introduces liquid into the receiving portion 54. The liquid inlet tube 60 is made of a thermoplastic resin such as EVA resin. In the first embodiment, the liquid inlet tube 60 is disposed between the first sheet portion 51 and the second sheet portion 52, with one end communicating with the receiving portion 54. The other end of the liquid inlet tube 60 is sterile and airtightly connected to a liquid receiving container (not shown) that contains the cryoprotectant 503.
[0035] Next, the method for storing biological samples such as cell slices in the cryopreservation container 5 of the first embodiment will be described. Figure 3 As shown, in the factory, the cryopreservation container 5 has its end side D2a in the D2 direction sealed by a weak sealing part 55 and a strong sealing part 56, and its end side D1b in the D1 direction sealed by a second sealing part 58. Because both the weak sealing part 55 and the strong sealing part 56 are formed on the end side D2a in the D2 direction, a reliable airtight state can be maintained. The cryopreservation container 5 is shipped with the outer edge of the end side D2b in the D2 direction unsealed. An opening 531 is formed on the outer edge of the end side D2b in the D2 direction of the cryopreservation container 5.
[0036] After shipment from the factory, in the cryopreservation container 5, the user introduces the cell slice 501 into the interior of the cryopreservation container 5 through the opening 531 on the outer edge of the end formed on the other side D2b in the D2 direction, thereby storing the cell slice 501 in the storage part 54.
[0037] Next, on the outer edge of the end of D2b on the other side of the D2 direction, as... Figure 4 As shown, the seal is achieved by the first sealing section 57. Then, cryoprotectant 503 is introduced into the receiving section 54 through the liquid inlet pipe 60 (see reference). Figure 2The liquid is introduced into the tube 60 and then sealed. This allows the user to collect and seal biological samples such as cell sheets 501 and other cells into the cryopreservation container 5. The cryopreservation container 5, containing the cell sheets 501 and other cells, is then cryopreserved.
[0038] Next, the method for opening the cryopreservation container 5 of the first embodiment will be described. When opening the cryopreservation container 5 to take out the cell slices 501, other cells, or other biological samples stored in the cryopreservation container 5, the cryopreservation container 5 is first thawed.
[0039] Next, as Figure 4 and Figure 5 As shown in the upper figure, the outer edge portion 59 of the container body 50, including the portion where the strong sealing portion 56 is formed (the end portion 51a of the first sheet portion 51 and the end portion 52a of the second sheet portion 52), is cut off by a cutting tool such as scissors. Alternatively, a cutting portion for cutting off the outer edge portion 59 may be provided in the container body 50 to facilitate cutting off the outer edge portion 59.
[0040] Next, as Figure 5 As shown in the lower section of the figure, the first sheet portion 51 and the second sheet portion 52 are moved to one side and the other side in the D3 direction in a manner that separates them from each other, and the first sheet portion 51 and the second sheet portion 52 are peeled off in the weak sealing portion 55 to open the container body 50.
[0041] The weak sealing portion 55 is a heat-sealed portion with a sealing strength that prevents the cryoprotectant 503 injected into the receiving portion 54 from leaking to the outside and a sealing strength that can be opened by hand. Therefore, the first sheet portion 51 and the second sheet portion 52 can be easily peeled off from the weak sealing portion 55. When peeling off the first sheet portion 51 and the second sheet portion 52 from the weak sealing portion 55, it is sufficient to remove the cell sheet 501, other cells, or other biological samples. Therefore, it is sufficient to peel off the first sheet portion 51 and the second sheet portion 52 from at least a portion of the weak sealing portion 55. The first sheet portion 51 and the second sheet portion 52 can be peeled off from the entire weak sealing portion 55, or from a portion of the weak sealing portion 55.
[0042] Therefore, the container body 50 can be opened, and the cell sheet 501 stored in the storage section 54 can be removed. Before the outer edge portion 59 containing the strong sealing portion 56 is cut off, the outer edge is closed by the strong sealing portion 56. After the strong sealing portion 56 is removed, the first sheet portion 51 and the second sheet portion 52 can be peeled off and opened in the weak sealing portion 55. Therefore, it is possible to prevent the cell sheet 501 stored in the storage section 54 from becoming contaminated.
[0043] The cryopreservation container 5 described above has an opening 531 at its end on the opposite side (D2b) in the D2 direction, serving as an inlet for receiving cell slices 501, other cells, and other biological samples. At its end on one side (D2a) in the D2 direction, it has a weak sealing portion 55 and a strong sealing portion 56, serving as an outlet for removing cell slices 501, other cells, and other biological samples. In other words, the cryopreservation container 5 is provided with an inlet for receiving cell slices 501, other cells, and other biological samples, and an outlet for removing cell slices 501, other cells, and other biological samples.
[0044] The cryopreservation container 5 according to the first embodiment described above has the following effects.
[0045] (1) The cryopreservation container 5 is configured as follows: it includes: a first sheet portion 51; a second sheet portion 52, which is arranged to overlap with the first sheet portion 51, and a receiving portion 54 is formed between the second sheet portion 52 and the first sheet portion 51; a weak sealing portion 55, which is formed on the outside of the receiving portion 54 in the first sheet portion 51 and the second sheet portion 52, and is formed by heat sealing the first sheet portion 51 and the second sheet portion 52; and a strong sealing portion 56, which is formed on the first sheet portion 51 and the second sheet portion 52 at a position on the outside of the receiving portion 54 than the first sealing portion 55, and is formed by heat sealing the first sheet portion 51 and the second sheet portion 52 with a stronger sealing strength than the first sealing portion 55.
[0046] Therefore, when opening the cryopreservation container 5, after cutting away the outer edge 59 (end portion 51a of the first sheet portion 51 and end portion 52a of the second sheet portion 52) of the cryopreservation container 5, which includes the portion forming the strong seal portion 56, the first sheet portion 51 and the second sheet portion 52 can be peeled off in the weak seal portion 55, thus opening the cryopreservation container 5. Therefore, before cutting away the outer edge 59 containing the strong seal portion 56, the outer edge is closed by the strong seal portion 56; after removing the strong seal portion 56, the first sheet portion 51 and the second sheet portion 52 can be peeled off and opened in the weak seal portion 55. Therefore, during opening, contamination of the cell sheet 501 stored inside the storage portion 54 can be prevented.
[0047] (2) The cryopreservation container 5 is configured as follows: it includes a first sealing part 57 and a second sealing part 58, which are formed on the outer edges of the first sheet-like part 51 and the second sheet-like part 52 without the weak sealing part 55 and the strong sealing part 56, and are formed by heat sealing with a stronger sealing strength than the first sealing part 55.
[0048] Here, the cryopreservation container 5 is manufactured in the factory by sealing in the weak sealing portion 55 and the strong sealing portion 56, and sealing at least a portion of the first sealing portion 57 and the second sealing portion 58. For example, in this embodiment, the cryopreservation container 5 is shipped from the factory with the second sealing portion 58 sealed and the first sealing portion 57 unsealed. After shipping from the factory, the user accesses the cryopreservation container 5 through the opening 531 at the end of the cryopreservation container 5 on the other side D2 direction (see reference). Figure 3 The container 5 can easily store biological samples such as cell slices into cryopreservation container 5 and seal them with the first sealing part 57.
[0049] Reference Figures 6-12 The cryopreservation container 1 of the second embodiment will be described below. Furthermore, in this description, when viewed from above, the direction in which one side of the container body 10, which is formed as a quadrilateral, 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 orthogonal. The stacking direction of the plurality of sheet-like members 11, 12, 13, and 14 of the container body 10 is referred to as the Z direction.
[0050] like Figures 6-9 As shown, the cryopreservation container 1 of the second embodiment includes a container body 10 and a cryoprotectant 103 (protectant) into which cryoprotectant can be introduced (see reference). Figure 10 The liquid inlet fitting 20 (fitting) is used. The container body 10 is constructed by stacking multiple sheet-like components 11, 12, 13, and 14. In the container body 10, a cell sheet 101 is stored in a three-dimensional storage portion 112 (described later) formed in the first sheet-like component 11. The cryopreservation container 1 is cryopreserved while containing biological samples such as cell sheets.
[0051] like Figures 8-12As shown, the container body 10 includes a first sheet member 11, a heat-resistant sheet member 12, a second sheet member 13, a third sheet member 14, a weak sealing portion 15 (first sealing portion), a strong sealing portion 16 (third sealing portion), a closed sealing portion 17 (second sealing portion), and a liquid inlet pipe-side closed sealing portion 18. The first sheet member 11, the second sheet member 13, and the third sheet member 14 are made of a flexible thermoplastic resin such as EVA resin (ethylene-vinyl acetate copolymer). The heat-resistant sheet member 12 is made of a sheet of material including a heat-resistant fluorine material, preferably a sheet of material such as PTFE (polytetrafluoroethylene). The first sheet member 11, the heat-resistant sheet member 12, the second sheet member 13, and the third sheet member 14 are made of a freeze-resistant material to enable freezing.
[0052] The main body of the container 10 is as follows Figure 9 The first sheet member 11, the heat-resistant sheet member 12, the second sheet member 13, and the third sheet member 14 shown are stacked together, and any two sheet members are stacked on top of each other as shown in the figure. Figures 10-12 It is formed by partially joining the weak sealing part 15, the strong sealing part 16, the closed sealing part 17, and the liquid inlet pipe side closed sealing part 18 as shown.
[0053] like Figure 9 As shown, the first sheet member 11, the heat-resistant sheet member 12, the second sheet member 13, and the third sheet member 14 are stacked in this order from one side Z1 to the other side Z2 in the Z direction. The container body 10, with the first sheet member 11, the heat-resistant sheet member 12, the second sheet member 13, and the third sheet member 14 stacked, is as follows: Figure 8 As shown, when viewed from above, it is roughly rectangular in shape, with one side extending in the X direction and the other side extending in the Y direction. A liquid inlet tube 20 is fitted to one end of the container body 10 in the Y direction. The liquid inlet tube 20 is disposed between the first sheet member 11 and the third sheet member 14 on one side of the cryopreservation container 1. The liquid inlet tube 20 allows cryoprotectant 103 to be introduced into the container body 10 (see reference). Figure 10 Furthermore, the liquid inlet tube 20 can be configured to be disposed between the first sheet member 11 and the second sheet member 13, or it can be configured to be disposed between the second sheet member 13 and the third sheet member 14, in one side of the cryopreservation container 1.
[0054] like Figure 9 As shown, the first sheet member 11 has a sheet-like portion 111 surrounding the storage portion and a three-dimensional storage portion 112 (storage portion). The sheet-like portion 111 surrounding the storage section is roughly rectangular in shape when viewed from above, with one side extending in the X direction and the other side extending in the Y direction.
[0055] like Figures 9-11 As shown, the three-dimensional storage portion 112 is formed by three-dimensional molding. When viewed from above, the three-dimensional storage portion 112 is formed into a three-dimensional shape recessed from the sheet-like portions 111 surrounding the storage portion. The three-dimensional storage portion 112 stores biological samples such as cell sheets 101 and other cells. The three-dimensional storage portion 112 has a storage portion body 113.
[0056] The main body of the storage section 113, when viewed from above, is circular. The main body of the storage section 113 is as follows: Figure 10 The cross-sectional shape shown is formed by cutting along the X direction, resulting in a rectangular shape extending in the Y direction, as... Figure 11 The cross-sectional shape shown is formed by cutting along the Y direction into a rectangular shape that extends in the Y direction.
[0057] In the three-dimensional storage section 112, a liquid inlet tube 20 is connected to one end of the container body 10 in the Y direction. In the three-dimensional storage section 112, when the cell sheet 101 is stored, cryoprotectant 103 (see reference) is introduced through the liquid inlet tube 20. Figure 10 Cell sheet 101 is formed by culturing cells collected from human tissue into a sheet shape. In this embodiment, cell sheet 101 is formed into a circular plate with a diameter slightly smaller than the inner diameter of the three-dimensional storage portion 112, so that when the cryopreservation container 1 is frozen, the three-dimensional storage portion 112, while containing cell sheet 101, remains as follows: Figure 10 As shown, it is filled with cryoprotectant 103. Furthermore, in this embodiment, cell sheets are used as an example of biological samples such as cells housed in the three-dimensional storage unit 112, but it is not limited to this. For example, the biological sample may also be a cell block (spherical body) formed by cells agglomerating together. Additionally, for example, a cell suspension containing cells as biological samples may also be housed in the three-dimensional storage unit 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 at the position separating it from the three-dimensional storage portion 112 when viewed from above, with a predetermined width open to the liquid inlet tube 20 side. The heat-resistant sheet member 12 has an opening 121 (heat-resistant sheet member opening) in the portion corresponding to the three-dimensional storage portion 112. Only one side of the liquid inlet tube 20 in the cryopreservation container 1 is sealed, and the opening 121 of the heat-resistant sheet member 12 is open. The opening 121 is open to the liquid inlet tube 20 side in the Y direction, avoiding the three-dimensional storage portion 112 and opening in a wider range than the three-dimensional storage portion 112. Furthermore, as... Figure 10 and Figure 12As shown, the heat-resistant sheet member 12, when viewed from above, does not form the weak sealing portion 15 (described later) and the strong sealing portion 16 (described later) and is disposed between the first sheet member 11 and the second sheet member 13 (described later) in the outer peripheral direction of the three-dimensional storage portion 112 that avoids the weak sealing portion 15 and the strong sealing portion 16. As a predetermined width of the heat-resistant sheet member 12, since the sealing portion 17 (described later) is sealed in the portion of the heat-resistant sheet member 12, it is preferably the same predetermined width as the sealing portion 17, for example, preferably 2 to 20 mm, more preferably 10 to 15 mm.
[0059] like Figure 9 As shown, the second sheet member 13 is stacked on the other side Z2 of the first sheet member 11 in the Z direction, sandwiching the heat-resistant sheet member 12. That is, the second sheet member 13 is stacked on the other side Z2 of the heat-resistant sheet member 12 in the Z direction. The second sheet member 13, when viewed from above, is formed in a U-shape that avoids the position of the three-dimensional storage portion 112 and is open on the side of the liquid inlet tube 20. The second sheet member 13 has an opening 131 (second sheet member opening) in the portion corresponding to the three-dimensional storage portion 112. The opening 131 is open on the side of the liquid inlet tube 20 in the Y direction, in a shape corresponding to the three-dimensional storage portion 112, in a manner that avoids the three-dimensional storage portion 112.
[0060] The third sheet member 14 is stacked in the Z direction on the other side Z2 of the second sheet member 13 (the side of the second sheet member 13 opposite to the first sheet member 11). When viewed from above, the third sheet member 14 is formed as a planar shape of the same size as the first sheet member 11, and is formed as a three-dimensional storage part 112 covering the first sheet member 11.
[0061] like Figure 10 and Figure 12 As shown, the weak sealing part 15, the strong sealing part 16, the closed sealing part 17, and the liquid inlet pipe side closed sealing part 18 are sealing parts formed by thermally joining any two of the first sheet member 11, the second sheet member 13, and the third sheet member 14 through heat sealing, ultrasonic sealing, or the like. Furthermore, the weak sealing part 15, the strong sealing part 16, the closed sealing part 17, and the liquid inlet pipe side closed sealing part 18 are not limited to sealing parts formed by thermal joining. For example, they may also be sealing parts formed by high-frequency welding or ultrasonic welding.
[0062] like Figure 12As shown, the weak sealing portion 15, when viewed from above, is formed on the outer periphery of the three-dimensional storage portion 112 of the first sheet member 11, outside the three-dimensional storage portion 112. The weak sealing portion 15 seals three sides of the cryopreservation container 1 where the liquid inlet tube 20 is not located. When viewed from above, the weak sealing portion 15 is formed in a U-shape with the liquid inlet tube 20 side open, surrounding the outer periphery of the three-dimensional storage portion 112 of the first sheet member 11, as shown... Figure 10 As shown, the first sheet member 11 and the second sheet member 13 are sealed. The weak seal 15 is a seal formed by heat sealing the first sheet member 11 and the second sheet member 13 with a seal strength that can be opened by hand. The weak seal 15 has a seal strength that prevents the cryoprotectant 103 injected into the three-dimensional storage part 112 from leaking to the outside.
[0063] like Figure 12 As shown, the strong sealing portion 16, when viewed from above, is formed on the outer periphery of the first sheet member 11, relative to the three-dimensional storage portion 112, outside the weak sealing portion 15. The strong sealing portion 16 seals the three sides of the cryopreservation container 1 where the liquid inlet tube 20 is not located, on the outer periphery of the weak sealing portion 15. At a position separating from the outer edge of the U-shaped portion of the weak sealing portion 15, the strong sealing portion 16, along the outer edges of the first sheet member 11 and the second sheet member 13, is arranged in a U-shape, with a predetermined width open to the liquid inlet tube 20 side. Figure 10 As shown, the first sheet member 11 and the second sheet member 13 are sealed. A strong seal 16 seals between the first sheet member 11 and the second sheet member 13 in a manner that surrounds the weak seal 15 and the heat-resistant sheet member 12. The strong seal 16 is a seal formed by heat sealing the first sheet member 11 and the second sheet member 13 with a stronger sealing strength than the weak seal 15. The strong seal 16 is a seal formed in a manner that prevents the surrounding liquid nitrogen from contacting the weak seal 15 and the heat-resistant sheet member 12 during freezing, and has a sealing strength that makes it difficult for a person to open by hand.
[0064] like Figure 12 As shown, the sealing portion 17, when viewed from above, is formed between the weak sealing portion 15 and the strong sealing portion 16, and is sealed in a U-shape with a predetermined width open to the liquid inlet pipe 20 side. The sealing portion 17, when viewed from above, is formed at least a portion of the locations where the heat-resistant sheet member 12 is disposed. The predetermined width of the sealing portion 17 is preferably 2 to 20 mm, and more preferably 10 to 15 mm. This prevents the sealing portion 17 from shifting and overlapping with other sealing portions, ensuring a reliable seal at the sealing position.
[0065] like Figure 10As shown, the closed sealing portion 17 is a sealing portion in which the second sheet member 13 and the third sheet member 14, which are not sealed by the weak sealing portion 15 and the strong sealing portion 16, are sealed in the portion stacked on the heat-resistant sheet member 12 in such a way that the cryoprotectant 103 injected into the three-dimensional storage portion 112 will not leak to the outside. The closed sealing portion 17 is a sealing portion with a sealing strength that is difficult to open by hand and is sealed by heat with a sealing strength stronger than that of the weak sealing portion 15. The sealing strength of the closed sealing portion 17 may be the same as that of the strong sealing portion 16, or it may be different from the sealing strength of the strong sealing portion 16.
[0066] like Figure 12 As shown, the liquid inlet fitting side sealing portion 18, at the end of the liquid inlet fitting 20 side in the Y direction, seals the first sheet member 11 and the third sheet member 14 when the liquid inlet fitting 20 is disposed between the first sheet member 11 and the third sheet member 14. The liquid inlet fitting side sealing portion 18 seals only one side of the liquid inlet fitting 20 of the cryopreservation container 1 with a sealing strength stronger than that of the weak sealing portion 15. The liquid inlet fitting side sealing portion 18 is a sealing portion with a sealing strength that is difficult for a person to open by hand.
[0067] Liquid inlet tube 20 introduces liquid into the three-dimensional storage portion 112. Liquid inlet tube 20 is made of thermoplastic resin such as EVA resin. In the second embodiment, liquid inlet tube 20 is disposed between the first sheet member 11 and the second sheet member 13 such that one end of the liquid inlet tube 20 communicates with the three-dimensional storage portion 112 of the first sheet member 11. The other end of the liquid inlet tube 20 is sterile and airtightly connected to a liquid storage container (not shown) that stores the cryoprotectant 103.
[0068] like Figures 6-8 As shown, the first sheet member 11, the second sheet member 13, and the third sheet member 14 are equipped with marks 115 and 116 that serve as cutting references when removing contents. In this embodiment, mark 115 is for cutting the stacked first sheet member 11, the second sheet member 13, and the third sheet member 14 along the X direction. Mark 116 is for cutting the stacked first sheet member 11, the second sheet member 13, and the third sheet member 14 along the Y direction. Figure 9 As shown, the reference numerals 115 and 116 are formed by overlapping and arranging a pair of recesses 11d and 11e of the first sheet member 11, a pair of recesses 13d and 13e of the second sheet member 13, and a pair of recesses 14d and 14e of the third sheet member 14.
[0069] When viewed from above, the pair of recesses 11d and 11e of the first sheet member 11, the pair of recesses 13d and 13e of the second sheet member 13, and the pair of recesses 14d and 14e of the third sheet member 14 are arranged in a stacked state.
[0070] like Figure 12 As shown, the pair of recesses 11d of the first sheet member 11, the pair of recesses 13d of the second sheet member 13, and the pair of recesses 14d of the third sheet member 14 are formed inwardly recessed at both ends in the X direction near the liquid inlet tube 20, at the end opposite to the side where the liquid inlet tube 20 is disposed in the Y direction of the cryopreservation container 1. Similarly, the pair of recesses 11e of the first sheet member 11, the pair of recesses 13e of the second sheet member 13, and the pair of recesses 14e of the third sheet member 14 are formed inwardly recessed at both ends in the Y direction near the side opposite to the side where the liquid inlet tube 20 is disposed in the X direction, at the end opposite to the side where the liquid inlet tube 20 is disposed in the X direction, at the end opposite to the side where the liquid inlet tube 20 is disposed in the X direction, at the end opposite to the side where the liquid inlet tube 20 is disposed in the X direction, at the end of the strong sealing portion 16 extending in the Y direction at both ends in the X direction of the cryopreservation container 1.
[0071] Mark 115 is formed by overlapping and arranging a pair of recesses 11d of the first sheet member 11, a pair of recesses 13d of the second sheet member 13, and a pair of recesses 14d of the third sheet member 14. At the end of the strong sealing portion 16 extending in the X direction at the end opposite to the side where the liquid inlet tube 20 is disposed in the Y direction of the cryopreservation container 1, it is formed inwardly in the X direction at both ends, thus serving as a mark when cutting along the X direction.
[0072] Mark 116 is formed by overlapping the pair of recesses 11e of the first sheet member 11, the pair of recesses 13e of the second sheet member 13, and the pair of recesses 14e of the third sheet member 14. It is formed in a concave shape at the end opposite to the side where the liquid inlet tube 20 is disposed in the Y direction, on the inner side of the strong sealing portion 16 extending in the Y direction at the two ends of the X direction of the cryopreservation container 1, which is formed in the X direction, so as to serve as a mark when cutting along the Y direction.
[0073] The strong seal 16 of the cryopreservation container 1 can be cut off using markings 115 and 116. Either marking 115 or 116 can be used to cut off the strong seal 16 of the cryopreservation container 1.
[0074] For example, by cutting the first sheet member 11, the second sheet member 13, and the third sheet member 14 along the X direction from mark 115, the strong sealing portion 16 extending in the X direction at the end of the cryopreservation container 1 on the side opposite to the side where the liquid inlet tube 20 is disposed can be cut off. Then, by cutting the first sheet member 11, the second sheet member 13, and the third sheet member 14 along the Y direction at both ends in the X direction and on the inner side of the strong sealing portion 16 extending in the Y direction, the strong sealing portion 16 extending in the Y direction at both ends in the X direction can be cut off.
[0075] Thus, by setting the mark 115 as the reference 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 member 11, the second sheet member 13, and the third sheet member 14 along the Y direction from mark 116, the strong sealing portion 16 extending in the Y direction at both ends of the cryopreservation container 1 in the X direction can be cut off. Then, by cutting the first sheet member 11, the second sheet member 13, and the third sheet member 14 along the X direction at the end opposite to the side where the liquid inlet tube 20 is disposed in the Y direction at the end of the strong sealing portion 16 extending in the X direction, the strong sealing portion 16 extending in the X direction at the end opposite to the side where the liquid inlet tube 20 is disposed can be cut off.
[0077] Thus, by setting the mark 116 as the reference 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 describe the method for storing biological samples such as cell slices in cryopreservation container 1. For example... Figure 13 The upper part of the image and Figure 14 As shown in the left figure, the cryopreservation container 1 is manufactured in the factory by stacking a first sheet member 11, a heat-resistant sheet member 12, and a second sheet member 13, and sealing them in a weak sealing portion 15 and a strong sealing portion 16. The cryopreservation container 1 is shipped from the factory with the third sheet member 14 sealed only on the liquid inlet fitting side of the sealing portion 18.
[0079] After the factory ships the goods, such as Figure 13 The middle section diagram and Figure 14As shown in the left figure, in a cryopreservation container 1 in which the first sheet member 11, the heat-resistant sheet member 12 and the second sheet member 13 are stacked and sealed in the weak sealing part 15 and the strong sealing part 16, the user stores the cell sheet 101 in the three-dimensional storage part 112.
[0080] Next, as Figure 13 As shown in the middle and lower sections, the third sheet member 14 is disposed on the Z2 side of the second sheet member 13, and the second sheet member 13 and the third sheet member 14 are sealed by the sealing part 17 in the part of the heat-resistant sheet member 12.
[0081] In this case, since a heat-resistant sheet member 12 is disposed on one side Z1 of the second sheet member 13 and the third sheet member 14, the first sheet member 11 will not melt due to heat, and the second sheet member 13 and the third sheet member 14 are sealed.
[0082] Then, as Figure 13 As shown in the lower section of the diagram, cryoprotectant 103 is introduced into the three-dimensional storage section 112 through the liquid inlet tube 20, thereby sealing the opening of the liquid inlet tube 20. This allows the user to store and seal biological samples such as cell slices 101 and other cells within the cryopreservation container 1. The cryopreservation container 1, containing the cell slices and other cells, is then cryopreserved.
[0083] Next, the method for opening the cryopreservation container 1 of the second embodiment will be described. When opening the cryopreservation container 1 to take out the cell slices 101, other cells, or other biological samples stored in the cryopreservation container 1, the cryopreservation container 1 is first thawed.
[0084] Next, as Figure 15 The upper section diagram, the middle section diagram and Figure 16 As shown, the outer peripheral portion 19 of the container body 10, including the portion where the strong sealing portion 16 is formed (the end portion 11a of the first sheet member 11, the end portion 13a of the second sheet member 13, the end portion 14a of the third sheet member 14, and the portion further outward than the sealing portion 17) is cut off by a cutting tool such as scissors.
[0085] Specifically, such as Figure 16As shown, by cutting the first sheet member 11, the second sheet member 13, and the third sheet member 14 along the X direction from mark 115, the strong sealing portion 16 extending in the X direction at the end of the cryopreservation container 1 on the side opposite to the side where the liquid inlet tube 20 is disposed can be cut off. Then, by cutting the first sheet member 11, the second sheet member 13, and the third sheet member 14 along the Y direction at both ends in the X direction, inside the strong sealing portion 16 extending in the Y direction, the strong sealing portion 16 extending in the Y direction at both ends in the X direction can be cut off.
[0086] Then, remove the heat-resistant sheet member 12 disposed between the first sheet member 11 and the second sheet member 13. Next, as... Figure 15 As shown in the lower section of the figure, the first sheet member 11 and the second sheet member 13 are stretched in the Z direction towards one side Z1 and the other side Z2 in a way that they are separated from each other at the outer edges of the outer edges. In the weak sealing portion 15, the first sheet member 11 and the second sheet member 13 are peeled off to open the container body 10. Since the weak sealing portion 15 is a sealing portion formed by heat sealing with a sealing strength that prevents the cryoprotectant liquid 103 injected into the three-dimensional storage portion 112 from leaking to the outside, a sealing strength that is weaker than that of the closed sealing portion 17, and a sealing strength that can be opened by hand, the second sheet member 13 is strongly sealed to the side of the third sheet member 14. Therefore, in the weak sealing portion 15, the first sheet member 11 and the second sheet member 13 can be easily peeled off.
[0087] Therefore, the container body 10 can be opened, and the cell sheet 101 stored in the three-dimensional storage section 112 can be removed. Before the outer peripheral portion 19 containing the strong sealing portion 16 is cut off, the outer peripheral portion is closed by the strong sealing portion 16. After the strong sealing portion 16 is removed, the first sheet member 11 and the second sheet member 13 can be peeled off and opened in the weak sealing portion 15. Therefore, it is possible to prevent the cell sheet 101 stored in the three-dimensional storage section 112 from becoming contaminated.
[0088] The cryopreservation container 1 according to the second embodiment described above has the following effects.
[0089] (3) The medical container 1 is configured as follows: it includes: a first sheet member 11 having a three-dimensional storage portion 112; a second sheet member 13 stacked on the first sheet member 11 having an opening 131; a third sheet member 14 stacked on the side of the second sheet member 13 opposite to the first sheet member 11 to cover the three-dimensional storage portion 112; a weak sealing portion 15 formed by joining and sealing the first sheet member 11 and the second sheet member 13 with a sealing strength that can be opened by hand; and a heat-resistant sheet member 12 disposed between two sheet members (the first sheet member 11 and the second sheet member 13) that are the same as the two sheet members sealed by the weak sealing portion 15, in the direction of avoiding the outer periphery of the three-dimensional storage portion 112 when viewed from above, and having an opening 121 in the portion corresponding to the three-dimensional storage portion 112.
[0090] Therefore, the cryopreservation container 1 is manufactured in the factory by stacking the first sheet member 11, the heat-resistant sheet member 12, and the second sheet member 13 and sealing them in the weak sealing portion 15. Thus, when using it, the user can easily store biological samples such as cell sheets in the cryopreservation container 1 by placing them therein and assembling the third sheet member 14. Furthermore, by sealing the stack of the first sheet member 11, the heat-resistant sheet member 12, and the second sheet member 13 with the third sheet member 14, the cryopreservation container 1 containing the biological sample can be sealed.
[0091] (4) The cryopreservation container 1 is configured such that the second sheet member 13 and the third sheet member 14, which are not sealed by the weak sealing part 15, have a closed sealing part 17 in the part that is stacked on the heat-resistant sheet member 12, which is formed by heat sealing with a stronger sealing strength than the weak sealing part 15.
[0092] Therefore, when the cryopreservation container 1 holds biological samples such as cell slices and is equipped with the third sheet-like component 14, the biological samples can be aseptically preserved by sealing the portion of the second sheet-like component 13 and the third sheet-like component 14 stacked on the heat-resistant sheet-like component 12 with the sealing part 17. Furthermore, the user can aseptically remove the samples without finely adjusting the seal strength. The cryopreservation container 1 can be used easily. When opening the cryopreservation container 1, after cutting away the outer peripheral portion 19 (the end portion 11a of the first sheet member 11, the end portion 13a of the second sheet member 13, and the end portion 14a of the third sheet member 14) of the container body 10, which includes the portion forming the strong seal 16, the first sheet member 11 and the second sheet member 13 can be peeled off in the weak seal 15, thus opening the container body 10. Therefore, before cutting away the outer peripheral portion 19 containing the strong seal 16, the outer periphery is sealed by the strong seal 16; after removing the strong seal 16, the first sheet member 11 and the second sheet member 13 can be peeled off and opened in the weak seal 15. Thus, contamination of the cell sheet 101 stored in the three-dimensional storage section 112 can be suppressed.
[0093] (5) The three-dimensional storage section 112 is formed by three-dimensional molding. As a result, biological samples such as cell sheets can be easily stored in the three-dimensional storage section 112.
[0094] (6) Between the first sheet member 11 and the second sheet member 13, there is a strong sealing part 16 that is sealed in such a way that it surrounds the weak sealing part 15 and the heat-resistant sheet member 12. Thus, by providing the strong sealing part 16 on the outer periphery of the weak sealing part 15, the airtightness of the three-dimensional storage part 112 can be improved.
[0095] (7) In one side of the cryopreservation container 1, between the first sheet member 11 and the third sheet member 14, there is a liquid inlet tube 20 that allows cryoprotectant 103 to be introduced from the outside into the three-dimensional storage section 112. Thus, cryoprotectant 103 for protecting biological samples such as cell sheets can be easily introduced into the interior of the three-dimensional storage section 112.
[0096] (8) The first sheet member 11 and the third sheet member 14 are sealed with a stronger sealing strength than the weak sealing portion 15, only on one side of the cryopreservation container 1 where the liquid inlet tube 20 is located. As a result, the cryopreservation container 1 is less prone to breakage, thus improving its breakage resistance.
[0097] (9) Between the first sheet member 11 and the second sheet member 13, there is a strong sealing portion 16 that is sealed around the weak sealing portion 15 and the heat-resistant sheet member 12. The weak sealing portion 15 and the strong sealing portion 16 are U-shaped seals formed by the three sides of the cryopreservation container 1 without the liquid inlet tube 20 when viewed from above. Thus, by cutting along the three sides of the cryopreservation container 1, biological samples such as cell slices can be easily removed from the cryopreservation container 1.
[0098] (10) The heat-resistant sheet member 12 has an opening 121 only on one side where the liquid inlet tube 20 in the cryopreservation container 1 is sealed. Thus, the heat-resistant sheet member 12 disposed between the first sheet member 11 and the second sheet member 13 can be easily removed.
[0099] (11) The three-dimensional storage section 112 is formed with a rectangular cross-section and extends in a predetermined direction. As a result, the thickness of the storage section can be kept constant in the three-dimensional storage section 112, thereby improving the strength of the storage section.
[0100] (12) The cryopreservation container 1 is used for cryopreservation. Thus, a medical container can be used as the cryopreservation container 1.
[0101] (13) The first sheet member 11, the second sheet member 13 and the third sheet member 14 are provided with a mark 115 that serves as a cutting reference when removing the contents. Thus, by cutting the first sheet member 11, the second sheet member 13 and the third sheet member 14 with the mark 115 as a reference, biological samples such as cell slices can be easily removed from the cryopreservation container 1.
[0102] Next, the cryopreservation container 1A of the third embodiment will be described. For example... Figure 17 and Figure 18 As shown, in the cryopreservation container 1A of the third embodiment, the first sheet member 11, the heat-resistant sheet member 12A, the second sheet member 13A, and the third sheet member 14 are stacked in the same order as the sheet 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 sealing portion 15A and the closed sealing portion 17A when viewed from above, as well as the shape and position of the heat-resistant sheet member 12A. In the third embodiment, the same reference numerals are used for the same configuration as in the second embodiment, and descriptions are omitted.
[0103] like Figure 17 and Figure 18 As shown, 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 sealing portion 15A, a strong sealing portion 16, and a closed sealing portion 17A. Figure 17 As shown, the first sheet member 11, the heat-resistant sheet member 12A, the second sheet member 13A, and the third sheet member 14 are stacked in the same order as in the second embodiment, moving from one side Z1 to the other side Z2 in the Z direction.
[0104] Regarding the heat-resistant sheet member 12A, when viewed from above, the heat-resistant sheet member 12 in the second embodiment is separately disposed from the three-dimensional storage portion 112, while in the third embodiment, as... Figure 18 As shown, the heat-resistant sheet member 12A is formed in a U-shape along the outer edge of the three-dimensional storage portion 112. The heat-resistant sheet member 12A is formed in a U-shape with the liquid inlet tube 20 disposed on one side in the Y direction. The heat-resistant sheet member 12A has an opening 121A (heat-resistant sheet member opening) in the portion corresponding to the three-dimensional storage portion 112. The opening 121A is open in the Y direction towards the liquid inlet tube 20 side, in a shape corresponding to the three-dimensional storage portion 112, in a manner that avoids the three-dimensional storage portion 112.
[0105] Regarding the weak sealing portion 15A, in top view, the weak sealing portion 15 in the second embodiment is formed along the outer edge of the three-dimensional receiving portion 112, while in the third embodiment, the weak sealing portion 15A is in a U-shaped portion of a predetermined width that is open on the side of the liquid inlet pipe 20 configured in the Y direction at a position separate from the three-dimensional receiving portion 112, such as... Figure 17 As shown, the first sheet member 11 and the second sheet member 13A are sealed.
[0106] Regarding the strong sealing portion 16, when viewed from above, it is similar to the second embodiment, as shown below. Figure 18 As shown, the strong sealing part 16 is located outside the weak sealing part 15A along the outer edge of the container body 10A, such as... Figure 17 As shown, the first sheet member 11 and the second sheet member 13A are sealed.
[0107] Regarding the sealing portion 17A, when viewed from above, in the second embodiment, the sealing portion 17 is formed in a U-shaped portion that is open on the side where the liquid inlet tube 20 is disposed, located at a position separate from the three-dimensional storage portion 112, while in the third embodiment, as... Figure 18 As shown, the sealing portion 17A is formed along the outer edge of the three-dimensional storage portion 112. When viewed from above, the sealing portion 17A is formed at at least a portion of the locations where the heat-resistant sheet member 12A is disposed.
[0108] In the third embodiment, when opening the cryopreservation container 1A for removal, firstly, the frozen cryopreservation container 1A is thawed. Then, as... Figure 17 and Figure 18 As shown, the outer peripheral portion 19A of the container body 10A, including the portion where the strong sealing portion 16 is formed (the end portion 11b of the first sheet member 11, the end portion 13b of the second sheet member 13A, and the end portion 14b of the third sheet member 14), is cut off by a cutting tool such as scissors in a cutting manner.
[0109] Next, in conjunction with the second embodiment... Figure 15 The steps for the next section of the diagram are the same. Figure 17In the process of cutting off the outer peripheral portion 19A, the first sheet member 11 and the second sheet member 13A are stretched in a Z-direction direction towards one side Z1 and the other side Z2, separating them from each other. In the weak sealing portion 15A, the first sheet member 11 and the second sheet member 13A are peeled off. Since the weak sealing portion 15A is a heat-sealed portion with a sealing strength that prevents the cryoprotectant 103 injected into the three-dimensional storage portion 112 from leaking to the outside and a sealing strength that can be opened by hand, the first sheet member 11 and the second sheet member 13A can be easily peeled off in the weak sealing portion 15A. Then, the heat-resistant sheet member 12A disposed between the first sheet member 11 and the second sheet member 13A is removed.
[0110] Therefore, the container body 10A can be opened, and the cell sheet 101 stored in the three-dimensional storage section 112 can be removed. Before the outer peripheral portion 19A containing the strong sealing portion 16 is cut off, the outer peripheral portion is closed by the strong sealing portion 16. After the strong sealing portion 16 is removed, the first sheet member 11 and the second sheet member 13A can be peeled off and opened in the weak sealing portion 15A. Therefore, it is possible to prevent the cell sheet 101 stored in the three-dimensional storage section 112 from becoming contaminated.
[0111] In the third embodiment, the same effect as in the second embodiment can be achieved.
[0112] Next, the cryopreservation container 1B of the fourth embodiment will be described. For example... Figure 19 and Figure 20 As shown, the cryopreservation container 1B of the fourth embodiment differs from the cryopreservation container 1 of the second embodiment mainly in the position of the stacked heat-resistant sheet members 12B, and the two sheet members sealed in the weak sealing portion 15B, the strong sealing portion 16B, and the closed sealing portion 17B are different. In the fourth embodiment, the same reference numerals are used for the same configuration as in the second embodiment, and descriptions are omitted.
[0113] like Figure 19 and Figure 20 As shown, the container body 10B includes a first sheet member 11, a second sheet member 13B, a heat-resistant sheet member 12B, a third sheet member 14, a weak sealing portion 15B, a strong sealing portion 16B, and a closed sealing portion 17B. The first sheet member 11, the second sheet member 13B, the heat-resistant sheet member 12B, and the third sheet member 14 are stacked in this order from one side Z1 to the other side Z2 in the Z direction.
[0114] The position of the laminated heat-resistant sheet member 12B in the fourth embodiment differs from that in the second embodiment. In the second embodiment, the heat-resistant sheet member 12 is disposed between the first sheet member 11 and the second sheet member 13, while in the fourth embodiment, as shown... Figure 19 As shown, the heat-resistant sheet member 12B is disposed between the second sheet member 13B and the third sheet member 14.
[0115] Although the layers of heat-resistant sheet member 12B disposed in the first sheet member 11, the second sheet member 13B, the heat-resistant sheet member 12B, and the third sheet member 14 are different from those in the second embodiment, they are all formed to the same size and shape and disposed in the same position when viewed from above.
[0116] like Figure 19 and Figure 20 As shown, the heat-resistant sheet member 12B, when viewed from above, does not form the weak sealing portion 15B and the strong sealing portion 16B and avoids the positions of the weak sealing portion 15B and the strong sealing portion 16B, and is disposed between the second sheet member 13B and the third sheet member 14. When viewed from above, the heat-resistant sheet member 12B is formed in a U-shape with one side open in the Y direction where the liquid inlet pipe 20 is disposed, at the position separated from the three-dimensional storage portion 112.
[0117] The weak sealing portion 15B is located at the same position and has the same extent as the weak sealing portion 15 in the second embodiment when viewed from above. Figure 19 The second sheet member 13B and the third sheet member 14 shown are formed by sealing. The strong sealing part 16B is located at the same position and in the same range as the strong sealing part 16 in the second embodiment when viewed from above. Figure 19 The second sheet member 13B and the third sheet member 14 shown are formed by sealing.
[0118] The sealing part 17B is located at the same position and in the same extent as the sealing part 17 in the second embodiment when viewed from above. Figure 19 The first sheet member 11 and the second sheet member 13B shown are formed by sealing. The closed sealing part 17B is formed at the position where the heat-resistant sheet member 12B is disposed when viewed from above.
[0119] In the fourth embodiment, when opening the cryopreservation container 1B for removal, firstly, the frozen cryopreservation container 1B is thawed. Then, as... Figure 19 and Figure 20As shown, the outer peripheral portion 19B of the container body 10B, including the portion where the strong sealing portion 16B is formed (the end portion 11c of the first sheet member 11, the end portion 13c of the second sheet member 13B, and the end portion 14c of the third sheet member 14), is cut off by scissors or a cutting tool in a cutting manner. Then, the heat-resistant sheet member 12B disposed between the second sheet member 13B and the third sheet member 14 is removed.
[0120] Next, in conjunction with the second embodiment... Figure 15 The steps for the next section of the diagram are the same. Figure 19 In the process of cutting off the outer peripheral portion 19B, the second sheet member 13B and the third sheet member 14 are stretched in a Z-direction direction towards one side Z1 and the other side Z2, separating them from each other. In the weak sealing portion 15B, the second sheet member 13B and the third sheet member 14 are peeled off to open the container body 10B. Since the weak sealing portion 15B is a sealing portion formed by heat sealing with a sealing strength that prevents the cryoprotectant liquid 103 injected into the three-dimensional storage portion 112 from leaking to the outside and a sealing strength that can be opened by hand, the second sheet member 13B and the third sheet member 14 can be easily peeled off in the weak sealing portion 15B.
[0121] Therefore, the container body 10B can be opened, and the cell sheet 101 stored in the three-dimensional storage section 112 can be removed. Before the outer peripheral portion 19B containing the strong sealing portion 16B is cut off, the outer periphery is closed by the strong sealing portion 16B. After the strong sealing portion 16B is removed, the second sheet member 13B and the third sheet member 14 can be peeled off and opened in the weak sealing portion 15B. Therefore, it is possible to prevent the cell sheet 101 stored in the three-dimensional storage section 112 from becoming contaminated.
[0122] In the fourth embodiment, the same effect as in the second embodiment can be achieved.
[0123] The above describes the embodiments of the present invention, but the present invention is not limited to these embodiments and can be implemented in various ways without departing from the spirit of the present invention. The present invention includes the following combinations.
[0124] <1> A medical container, used in medical settings, comprising: The first sheet-like component has a storage section; The second sheet-like member is stacked on top of the first sheet-like member and has an opening in the second sheet-like member in the portion corresponding to the receiving portion; The third sheet member is stacked on the side of the second sheet member opposite to the first sheet member to form a cover for the storage portion; The first sealing portion is formed by joining and sealing the first sheet member and the second sheet member, or the second sheet member and the third sheet member, with a sealing strength that allows it to be opened by hand; and The non-welded area component, which, when viewed from above, avoids the outer periphery of the receiving portion of the first sealing portion, is disposed between the two sheet-like components that are the same as the two sheet-like components sealed by the first sealing portion, and has a non-welded area component opening hole in the portion corresponding to the receiving portion. <2> According to the medical container described in <1>, wherein, The first sheet member and the second sheet member, or the second sheet member and the third sheet member, in the portion of the two sheet members not sealed by the first sealing part, have a second sealing part formed by heat sealing with a stronger sealing strength than the first sealing part in the portion of the non-welded area member. <3> According to the medical container described in <1> or <2>, wherein, The storage section is formed by three-dimensional molding. <4> The medical container according to any one of <1> to <3>, wherein, Between the first sheet member and the second sheet member, there is a third sealing part that is sealed in such a way as to surround the first sealing part and the non-welded area member. <5> The medical container according to any one of <1> to <4>, wherein, In one side of the medical container, between the first sheet member and the second sheet member, between the second sheet member and the third sheet member, or between the first sheet member and the third sheet member, there is a tube that can introduce a protective agent into the receiving part from the outside. <6> According to the medical container described in <5>, wherein, Only on one side of the medical container where the tubing is located, the first sheet member and the second sheet member, the second sheet member and the third sheet member, or the first sheet member and the third sheet member are sealed with a stronger sealing strength than the first sealing portion. <7> According to the medical container described in <5>, wherein, Between the first sheet member and the second sheet member, there is a third sealing portion formed to seal around the first sealing portion and the non-welded area member. Both the first and third sealing portions are U-shaped seals formed when viewed from above on the three sides of the medical container where the tubing is not located. <8> According to the medical container described in <6>, wherein, The non-welded area component has an opening only on one side of the tube in the medical container where the tube is sealed. <9> According to the medical container described in <3>, wherein... The storage section is formed in a rectangular cross-sectional shape and extends in a specified direction. <10> The medical container according to any one of <1> to <9>, wherein, The medical container is used for cryopreservation. <11> According to the medical container described in <4>, wherein, The first sheet member, the second sheet member, and the third sheet member are provided with markings that serve as a reference for cutting when removing the contents.
[0125] The above describes preferred embodiments of the cryopreservation container of the present invention, but the present invention is not limited to the above embodiments and can be appropriately modified.
[0126] For example, in the first embodiment, the weak sealing portion 55 (first sealing portion) and the strong sealing portion 56 (second sealing portion) are provided on one side of the end of one side D2a in the D2 direction of the cryopreservation container 5, but it is not limited to this. The weak sealing portion 55 (first sealing portion) and the strong sealing portion 56 (second sealing portion) may also be provided on other sides of the cryopreservation container 5, or they may be provided on multiple sides.
[0127] In the first embodiment, a space is provided between the weak sealing portion 55 (first sealing portion) and the strong sealing portion 56 (second sealing portion) to facilitate the cutting off of the outer edge portion 59, but this is not a limitation. Alternatively, no space may be provided between the weak sealing portion 55 (first sealing portion) and the strong sealing portion 56 (second sealing portion).
[0128] In the first embodiment, the first sheet portion 51 and the second sheet portion 52 are formed from sheet portions 53 on which the first sheet portion 51 and the second sheet portion 52 are continuously formed, and are formed by folding back into an arc shape at the end on one side D1a in the D1 direction, but it is not limited to this. Alternatively, the first sheet portion 51 and the second sheet portion 52 may be formed from separate sheet portions, and are sealed at the end on one side D1a in the D1 direction by a sealing portion.
[0129] In the first embodiment, a liquid inlet tube 60 for introducing cryoprotectant is provided in the cryopreservation container 5. In the second embodiment, liquid inlet tubes 60 and 20 for introducing cryoprotectant are provided in the cryopreservation container 1. However, this is not a limitation. In the first and second embodiments, the liquid inlet tubes 60 and 20 may not be provided, and all four sides may be sealed by the sealing part.
[0130] In embodiments 2 to 4, a three-dimensional storage portion 112 is provided as a storage portion, but the embodiments are not limited thereto. Alternatively, the first sheet member 11 may not have a three-dimensional storage portion, but may be formed as a planar shape, with the portion between the first sheet member 11 and the third sheet member 14 serving as the storage portion. In this case, for example, a liquid biological sample containing cells may be stored in the storage portion.
[0131] In embodiments 2 to 4, the three-dimensional storage section 112 is formed into a circular shape when viewed from above, but is not limited to this. For example, the three-dimensional storage section 112 may also be formed into a rectangular shape, an elliptical shape, or a polygonal shape when viewed from above. Furthermore, the cross-sectional shape of the three-dimensional storage section 112 is formed into a rectangular shape, but is not limited to this. For example, the cross-sectional shape of the three-dimensional storage section 112 may also be formed into a circular shape, an elliptical shape, or a polygonal shape.
[0132] In embodiments 2 to 4, the medical container is designed as a cryopreservation container that can be stored in a frozen state, but it is not limited to this. For example, the medical container may also be designed as a container that can be transported and stored in a refrigerated state or at room temperature.
[0133] In embodiments 2 to 4, the medical container is constructed from a cryopreservation container capable of being stored in a frozen state, and the storage compartment is filled with a cryoprotectant for cryopreservation, but this is not a limitation. When the medical container is constructed from a container capable of being transported and stored in a refrigerated state or at room temperature, the storage compartment may not be filled with a cryoprotectant, and gas may be present in the storage compartment. Explanation of reference numerals in the attached figures
[0134] 5. Cryopreservation containers (medical containers) 51 1st sheet part 52 2nd sheet part 54 Storage Department 55 Weak sealing section (first sealing section) 56 Strong sealing part (second sealing part) 57 First sealing part (third sealing part) 58. Second sealing part (fourth sealing part) 1. 1A, 1B Cryopreservation Containers (Medical Containers) 11 First sheet-like component 12, 12A, 12B Heat-resistant sheet-like components (non-welded area components) 13, 13A, 13B Second plate-shaped component 14 Third sheet-like component 15, 15A, 15B Weak sealing section (first sealing section) 16, 16B Strong sealing section (3rd sealing section) 17, 17A, 17B Sealing section (second sealing section) 20 Liquid inlet fittings (pipe fittings) 103 Cryoprotectant (Cryoprotectant) 112. Vertical Storage Unit (Storage Section) 115 mark 131 Opening hole (opening hole of the second plate-shaped component) 121 Opening hole (opening hole in non-welded area component).
Claims
1. A medical container, characterized in that, have: 1st sheet part; The second sheet portion is arranged to overlap with the first sheet portion, and a storage portion is formed between the second sheet portion and the first sheet portion; A first sealing portion, formed on the outside of the receiving portion in the first sheet-like portion and the second sheet-like portion, is formed by heat sealing the first sheet-like portion and the second sheet-like portion; and The second sealing portion, which is formed in the first sheet portion and the second sheet portion at a location on the outer side relative to the receiving portion than the first sealing portion, is formed by heat sealing the first sheet portion and the second sheet portion with a stronger sealing strength than the first sealing portion.
2. The medical container according to claim 1, wherein, It includes: a third sealing portion, which is formed on the outer edge of the first sheet portion and the second sheet portion where the first sealing portion and the second sealing portion are not provided, and is formed by heat sealing with a stronger sealing strength than the first sealing portion.
3. A medical container, used in medical practice, characterized in that, have: The first sheet-like component has a storage section; The second sheet-like member is stacked on top of the first sheet-like member and has an opening in the second sheet-like member in the portion corresponding to the receiving portion; The third sheet member is stacked on the side of the second sheet member opposite to the first sheet member to form a cover for the storage portion; The first sealing part is formed by joining and sealing the first sheet member and the second sheet member, or the second sheet member and the third sheet member, with a sealing strength that can be opened by hand; as well as The non-welded area component, which, when viewed from above, avoids the outer periphery of the receiving portion of the first sealing portion, is disposed between the two sheet-like components that are the same as the two sheet-like components sealed by the first sealing portion, and has a non-welded area component opening hole in the portion corresponding to the receiving portion.
4. The medical container according to claim 3, wherein, The first sheet member and the second sheet member, or the second sheet member and the third sheet member, in the portion of the two sheet members not sealed by the first sealing part, have a second sealing part formed by heat sealing with a stronger sealing strength than the first sealing part in the portion of 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. The medical container according to claim 3 or 4, wherein, Between the first sheet member and the second sheet member, there is a third sealing part that is sealed in such a way as to surround the first sealing part and the non-welded area member.
7. The medical container according to claim 3 or 4, wherein, In one side of the medical container, between the first sheet member and the second sheet member, between the second sheet member and the third sheet member, or between the first sheet member and the third sheet member, there is a tube that can introduce a protective agent into the receiving part from the outside.
8. The medical container according to claim 7, wherein, Only on one side of the medical container where the tubing is located, the first sheet member and the second sheet member, the second sheet member and the third sheet member, or the first sheet member and the third sheet member are sealed with a stronger sealing strength than the first sealing portion.
9. The medical container according to claim 7, wherein, Between the first sheet member and the second sheet member, there is a third sealing portion formed to seal around the first sealing portion and the non-welded area member. Both the first and third sealing portions are U-shaped seals formed when viewed from above, covering the three sides of the medical container where the tubing is not located.
10. The medical container according to claim 8, wherein, The non-welded area component has an opening only on one side of the tube in the medical container where the tube is sealed.
11. The medical container according to claim 5, wherein, The storage section is formed in a rectangular cross-section and extends in a specified direction.
12. The medical container according to claim 3, wherein, The medical container is used for cryopreservation.
13. The medical container according to claim 6, wherein, The first sheet member, the second sheet member, and the third sheet member are provided with markings that serve as a reference for cutting when removing the contents.
Citation Information
Patent Citations
Container for freeze preservation and method of freeze preservation
JP2007302567A