Medical container
The medical container employs a dual-seal system to prevent contamination of biological samples during opening, ensuring the sterility of the samples by using a strong seal that only opens via a weak seal accessible by hand.
Patent Information
- Application Number
- JP2023160038
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2023-09-25
- Publication Date
- 2025-04-04
AI Technical Summary
Conventional medical containers risk contaminating biological samples when opened, as bacteria can enter through the cutting device used to open the container.
A medical container design featuring a first and second sheet-like portion with a housing portion between them, sealed by heat with distinct seal strengths: a weak seal portion for easy opening and a strong seal portion to prevent contamination.
The container effectively prevents contamination of biological samples by ensuring that the strong seal portion maintains the sample's sterility until the weak seal portion is opened, allowing for safe handling and removal of the samples.
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Figure 2025051112000001_ABST
Abstract
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). A biological sample such as a cell is contained in the medical container, 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 instrument. [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, and 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 comprising a first sheet-like portion, a second sheet-like portion arranged to overlap the first sheet-like portion and forming a storage portion between the first sheet-like portion and the second sheet-like portion, a first seal portion formed outside the storage portion in the first sheet-like portion and the second sheet-like portion and formed by heat sealing the first sheet-like portion and the second sheet-like portion, and a second seal portion formed outside the first seal portion with respect to the storage portion in the first sheet-like portion and the second sheet-like portion and formed by heat sealing the first sheet-like portion and the second sheet-like portion with a seal strength stronger than that of the first seal portion.
[0007] It is also preferable that the first sheet-like portion and the second sheet-like portion have a third seal portion formed on the outer edge where the first seal portion and the second seal portion are not provided, and is sealed by heat with a seal strength stronger than that of the first seal portion. Effect of the Invention
[0008] 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]
[0009] [Figure 1] 1 is a perspective view of a cryopreservation container according to a first embodiment of the present invention, seen obliquely from the side. [Diagram 2] 2 is a cross-sectional view taken along line AA in FIG. 1. [Diagram 3] FIG. 2 is a side view showing a case where a biological sample is stored in the cryopreservation container according to the first embodiment. [Figure 4] FIG. 2 is a side view showing the case where the cryopreservation container according to the first embodiment is opened. [Diagram 5] 4 is a cross-sectional view showing the case where the cryopreservation container according to the first embodiment is opened. FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0010] Hereinafter, preferred embodiments of the cryopreservation container 5 as a medical container of the present invention will be described with reference to the drawings. The cryopreservation container 5 of the present invention is used in medical applications, and is used when cryopreserving biological samples such as cell sheets and other cells.
[0011] A cryopreservation container 5 of a first embodiment will be described with reference to Figures 1 and 2. In the description of this embodiment, in a side view of the cryopreservation container 5, a direction along the vertical side of the container body 50 is referred to as a D1 direction, and a direction along the horizontal side of the container body 50 is referred to as a D2 direction. The D1 direction and the D2 direction are perpendicular to each other. The stacking direction of the multiple sheet-like portions 51, 52 of the container body 50 is referred to as a D3 direction.
[0012] As shown in Figs. 1 and 2, the cryopreservation container 5 of the first embodiment includes a container body 50 and a liquid introduction tube 60 capable of introducing a cryoprotective liquid 503 (see Fig. 2). The container body 50 has a storage section 54 between a first sheet-shaped section 51 and a second sheet-shaped section 52, and is formed into a pouch shape (bag shape) with the outer edges of the first sheet-shaped section 51 and the second sheet-shaped section 52 sealed. The container body 50 is formed into a rectangular shape (almost square shape) in a side view. A cell sheet 101 is stored in the storage section 54. The cell sheet 101 is formed into a sheet shape by culturing cells collected from human tissue. Thus, when the cryopreservation container 1 is frozen, the storage section 54 is filled with the cryoprotective liquid 503 in a state where the cell sheet 101 is stored therein, as shown in Fig. 5. The cryopreservation container 5 is cryopreserved in a state where a biological sample such as a cell sheet is stored therein.
[0013] In this embodiment, a cell sheet is described as an example of a biological sample such as cells to be stored in the storage unit 54, but the present invention is not limited thereto. For example, the biological sample may be a tissue piece in which cells form a mass. In addition, for example, a cell suspension containing cells as the biological sample may be stored in the storage unit 54.
[0014] The container body 50 is arranged such that a sheet-like portion 53 formed by continuously forming a first sheet-like portion 51 and a second sheet-like portion 52 is folded back in an arc shape at an end portion on one side D1a in the D1 direction and overlapped with each other at an end portion on the other side D1b in the D1 direction, so that the first sheet-like portion 51 and the second sheet-like portion 52 overlap. The first sheet-like portion 51 and the second sheet-like portion 52 are sealed at their outer edges except for the portion where the sheet-like portion 53 is folded back in an arc shape.
[0015] The first sheet-shaped portion 51, the second sheet-shaped portion 52, and the liquid introduction tube 60 are made of a flexible thermoplastic resin such as EVA resin (ethylene-vinyl acetate copolymer resin). The first sheet-shaped portion 51, the second sheet-shaped portion 52, and the liquid introduction tube 60 are made of a freeze-resistant material so that they can be frozen.
[0016] 1, the first sheet-like portion 51 and the second sheet-like portion 52 are joined at a weak seal portion 55 (first seal portion), a strong seal portion 56 (second seal portion), a first sealing portion 57 (third seal portion), and a second sealing portion 58 (third seal portion). A storage portion 54 is formed between the first sheet-like portion 51 and the second sheet-like portion 52.
[0017] The weak seal portion 55, the strong seal portion 56, the first sealing seal portion 57 and the second sealing seal portion 58 are seal portions formed by joining the first sheet-like portion 51 and the second sheet-like portion 52 using heat, such as heat sealing or ultrasonic sealing.
[0018] As shown in Fig. 1, the weak seal portion 55 is formed on one side D2a in the D2 direction of the first sheet-like portion 51 and the second sheet-like portion 52 outside the storage portion 54 in a side view. The weak seal portion 55 is formed in a straight line extending in the D1 direction in a side view, and seals the first sheet-like portion 51 and the second sheet-like portion 52. The weak seal portion 55 is a seal portion where the first sheet-like portion 51 and the second sheet-like portion 52 are sealed by heat with a seal strength that allows the first sheet-like portion 51 and the second sheet-like portion 52 to be opened by hand. The weak seal portion 55 has a seal strength that prevents the cryoprotectant liquid 503 (see Fig. 2) injected into the storage portion 54 from leaking out to the outside.
[0019] The strong seal portion 56 is formed on one side D2a in the D2 direction of the first sheet-like portion 51 and the second sheet-like portion 52, outside the weak seal portion 55 with respect to the storage portion 54, in a side view. The strong seal portion 56 is formed in a linear shape extending in the D1 direction along the outer edge of the first sheet-like portion 51 and the outer edge of the second sheet-like portion 52 at a position away from the weak seal portion 55, and seals the first sheet-like portion 51 and the second sheet-like portion 52. The strong seal portion 56 is a seal portion in which the first sheet-like portion 51 and the second sheet-like portion 52 are sealed by heat with a seal strength stronger than that of the weak seal portion 55. The strong seal portion 56 is a seal portion that prevents the cryoprotectant liquid 503 injected into the storage portion 54 from leaking out, prevents the surrounding liquid nitrogen used during freezing from entering the inside, and has a seal strength that is strong enough to prevent a person from opening it by hand.
[0020] The first sealing seal portion 57 and the second sealing seal portion 58 are formed on the outer edges of the first sheet-shaped portion 51 and the second sheet-shaped portion 52 in parts that are not sealed by the weak seal portion 55 and the strong seal portion 56.
[0021] The first sealing portion 57 is formed to extend linearly in the D1 direction at the outer edge of the end portion on the other side D2b in the D2 direction in a side view, and seals the first sheet-like portion 51 and the second sheet-like portion 52 together. The second sealing portion 58 seals the first sheet-shaped portion 51 and the second sheet-shaped portion 52 at an end portion on one side D1a in the D1 direction where the liquid introduction tube 60 is disposed, with the liquid introduction tube 60 disposed between the first sheet-shaped portion 51 and the second sheet-shaped portion 52. The second sealing portion 58 extends linearly in the D2 direction at an end portion on the other side D1b in the D1 direction in a side view.
[0022] The first sealing portion 57 and the second sealing portion 58 are sealing portions that seal to prevent the cryoprotectant liquid 503 injected into the storage portion 54 from leaking out to the outside. The first sealing portion 57 and the second sealing portion 58 have a seal strength that makes them impossible to open by hand, and are sealed by heat with a seal strength stronger than that of the weak sealing portion 55. The seal strength of the first sealing portion 57 and the second sealing portion 58 may be the same as or different from the seal strength of the strong sealing portion 56.
[0023] The liquid introduction tube 60 is attached to the end of the other side D1b in the D1 direction at the end side of the other side D2b in the D2 direction of the container body 50. The liquid introduction tube 60 introduces liquid into the storage section 54. The liquid introduction tube 60 is made of a thermoplastic resin such as EVA resin. In the first embodiment, the liquid introduction tube 60 is disposed between the first sheet-shaped portion 51 and the second sheet-shaped portion 52 so that one end side communicates with the storage section 54. The other end side of the liquid introduction tube 60 is aseptically and airtightly connected to a liquid storage container (not shown) that stores, for example, a cryoprotectant liquid 503.
[0024] Next, a method for storing a biological sample such as a cell sheet in the cryopreservation container 5 of the first embodiment will be described. As shown in FIG. 3, the end side of the cryopreservation container 5 on one side D2a in the D2 direction is sealed by a weak seal part 55 and a strong seal part 56 at the factory, and the end side of the other side D1b in the D1 direction is sealed by a second sealing part 58. Since both the weak seal part 55 and the strong seal part 56 are formed on the end side of the one side D2a in the D2 direction, it is possible to reliably maintain a sealed state. The cryopreservation container 5 is shipped in a state where the outer edge of the end side of the other side D2b in the D2 direction is not sealed. The cryopreservation container 5 has an opening 531 formed on the outer edge of the end side of the other side D2b in the D2 direction.
[0025] After shipment from the factory, the user of the cryopreservation container 5 stores the cell sheet 101 in the storage section 54 by introducing it into the interior of the cryopreservation container 5 through the opening 531 formed on the outer edge of the end portion on the other side D2b in the D2 direction.
[0026] Next, the outer edge of the end on the other side D2b in the D2 direction is sealed with the first sealing part 57, as shown in Fig. 4. Thereafter, a cryoprotectant 503 (see Fig. 2) is introduced into the storage part 54 through the liquid introduction tube 60, and the opening of the liquid introduction tube 60 is sealed. In this way, the user can store and seal a biological sample, such as the cell sheet 101 or other cells, in the cryopreservation container 5. Thereafter, the cryopreservation container 5 containing the cell sheet 101, other cells, etc. is cryopreserved.
[0027] Next, a method for opening the cryopreservation container 5 of the first embodiment will be described. When opening the cryopreservation container 5 to take out biological samples such as the cell sheet 101 or other cells contained in the cryopreservation container 5, the frozen cryopreservation container 5 is first thawed.
[0028] 4 and 5, the outer edge portion 59 (end portion 51a of the first sheet-like portion 51 and end portion 52a of the second sheet-like portion 52) including the portion where the strong seal portion 56 of the container body 50 is formed is cut off with a cutting tool such as scissors. Note that the container body 50 may be provided with a cutout portion for cutting off the outer edge portion 59 so that it can be easily cut off.
[0029] Next, as shown in the lower diagram of Figure 5, the first sheet-like portion 51 and the second sheet-like portion 52 are moved to one side and the other side in the D3 direction at the outer edges thereof so that they move away from each other, and the first sheet-like portion 51 and the second sheet-like portion 52 are peeled away from each other at the weak seal portion 55 to open the container body 50.
[0030] The weakly sealed portion 55 has a seal strength that prevents the cryoprotective liquid 503 injected into the storage portion 54 from leaking out, and is a seal portion that is heat-sealed with a seal strength that allows a person to open it by hand, so that the first sheet-like portion 51 and the second sheet-like portion 52 can be easily peeled off at the weakly sealed portion 55. When peeling off the first sheet-like portion 51 and the second sheet-like portion 52 at the weakly sealed portion 55, it is only necessary to be able to take out the cell sheet 101 and other biological samples such as cells, so that the first sheet-like portion 51 and the second sheet-like portion 52 may be peeled off at least a part of the weakly sealed portion 55. The first sheet-like portion 51 and the second sheet-like portion 52 may be peeled off at the entire weakly sealed portion 55, or the first sheet-like portion 51 and the second sheet-like portion 52 may be peeled off at a part of the weakly sealed portion 55.
[0031] This allows the container body 50 to be opened and the cell sheet 101 contained in the storage section 54 to be removed. Before cutting the outer edge 59 including the strong seal section 56, the outer edge is sealed by the strong seal section 56, and after removing the strong seal section 56, the first sheet-like section 51 and the second sheet-like section 52 can be peeled away from each other to open the container at the weak seal section 55. This prevents the cell sheet 101 contained in the storage section 54 from being contaminated.
[0032] In the above cryopreservation container 5, an opening 531 serving as an entrance for storing biological samples such as the cell sheet 101 and other cells is provided at the end on the other side D2b in the D2 direction, and a weak seal part 55 and a strong seal part 56 serving as an exit for removing biological samples such as the cell sheet 101 and other cells are provided at the end side of one side D2a in the D2 direction. That is, the cryopreservation container 5 is provided with a separate entrance for storing biological samples such as the cell sheet 101 and other cells, and an exit for removing them.
[0033] The cryopreservation container 5 of the first embodiment described above provides the following advantages.
[0034] (1) The cryopreservation container 5 is configured to include a first sheet-like portion 51, a second sheet-like portion 52 arranged to overlap the first sheet-like portion 51 and forming a storage portion 54 between the first sheet-like portion 51 and the second sheet-like portion 52, a weak seal portion 55 formed outside the storage portion 54 in the first sheet-like portion 51 and the second sheet-like portion 52 and where the first sheet-like portion 51 and the second sheet-like portion 52 are sealed by heat, and a strong seal portion 56 formed outside the first seal portion 55 with respect to the storage portion 54 in the first sheet-like portion 51 and the second sheet-like portion 52 and where the first sheet-like portion 51 and the second sheet-like portion 52 are sealed by heat with a seal strength stronger than that of the first seal portion 55.
[0035] Therefore, when opening the cryopreservation container 5, the outer edge portion 59 (the end portion 51a of the first sheet-like portion 51 and the end portion 52a of the second sheet-like portion 52) including the portion where the strong seal portion 56 of the cryopreservation container 5 is formed is cut off, and then the first sheet-like portion 51 and the second sheet-like portion 52 are peeled off at the weak seal portion 55 to open the cryopreservation container 5. Therefore, before cutting the outer edge portion 59 including the strong seal portion 56, the outer edge is sealed by the strong seal portion 56, and after removing the strong seal portion 56, the first sheet-like portion 51 and the second sheet-like portion 52 are peeled off to open the cryopreservation container 5 at the weak seal portion 55. Therefore, contamination of the cell sheet 101 contained inside the container portion 54 can be suppressed when opening.
[0036] (2) The cryopreservation container 5 is configured to include a first sealing portion 57 and a second sealing portion 58 formed on the outer edges of the first sheet-shaped portion 51 and the second sheet-shaped portion 52 where the weak sealing portion 55 and the strong sealing portion 56 are not provided, and sealed by heat with a sealing strength stronger than that of the first sealing portion 55.
[0037] Here, the cryopreservation container 5 is produced in a factory by sealing the weak seal portion 55 and the strong seal portion 56, and at least a part of the first seal portion 57 and the second seal portion 58. For example, in this embodiment, the cryopreservation container 5 is in a state where the second seal portion 58 is sealed and the first seal portion 57 is not sealed when shipped from the factory. After shipping from the factory, a user can easily store a biological sample such as a cell sheet in the cryopreservation container 5 by storing the biological sample such as a cell sheet through the opening 531 (see FIG. 3 ) at the end portion on the other side D2b in the D2 direction of the cryopreservation container 5 and sealing it with the first seal portion 57.
[0038] 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.
[0039] For example, in the first embodiment, the weak seal portion 55 (first seal portion) and the strong seal portion 56 (second seal portion) are provided on one side of the end portion on one side D2a in the D2 direction of the cryopreservation container 5, but this is not limited to this. The weak seal portion 55 (first seal portion) and the strong seal portion 56 (second seal portion) may also be provided on other sides of the cryopreservation container 5, or may be provided on multiple sides.
[0040] In the first embodiment, a space is provided between the weakly sealed portion 55 (first sealed portion) and the strongly sealed portion 56 (second sealed portion) to facilitate separation of the outer edge portion 59, but this is not limited thereto. It is not necessary to provide a space between the weakly sealed portion 55 (first sealed portion) and the strongly sealed portion 56 (second sealed portion).
[0041] In the first embodiment, the first sheet-like portion 51 and the second sheet-like portion 52 are formed by a sheet-like portion 53 in which the first sheet-like portion 51 and the second sheet-like portion 52 are continuously formed, and are folded back in an arc shape at the end on one side D1a in the D1 direction, but this is not limited thereto. The first sheet-like portion 51 and the second sheet-like portion 52 may be formed by separate sheet-like portions, and may be sealed by a seal portion at the end on one side D1a in the D1 direction.
[0042] In the first embodiment, the cryopreservation container 5 is provided with a liquid introduction tube 60 capable of introducing a cryoprotective liquid, and in the second embodiment, the cryopreservation container 1 is provided with a liquid introduction tube 60 capable of introducing a cryoprotective liquid. However, this is not limited to this. In the first and second embodiments, the liquid introduction tube 60 may not be provided, and all four sides may be sealed with a seal portion. [Explanation of symbols]
[0043] 5. Cryopreservation containers (medical containers) 51 First sheet-shaped portion 52 Second sheet-shaped portion 54 Storage unit 55 Weak seal part (first seal part) 56 Strong seal part (second seal part) 57 First sealing portion (third sealing portion) 58 Second sealing portion (fourth sealing portion)
Claims
1. A first sheet-like portion; a second sheet-like portion disposed so as to overlap the first sheet-like portion and forming a storage portion between the first sheet-like portion and the second sheet-like portion; a first seal portion formed on the outer side of the storage portion of the first sheet-like portion and the second sheet-like portion, the first sheet-like portion and the second sheet-like portion being sealed by heat; a second seal portion formed outside the first seal portion with respect to the containing portion in the first sheet-like portion and the second sheet-like portion, the first sheet-like portion and the second sheet-like portion being heat-sealed with a seal strength stronger than that of the first seal portion.
2. The medical container according to claim 1, further comprising a third seal portion formed on an outer edge of the first sheet-like portion and the second sheet-like portion where the first seal portion and the second seal portion are not provided, and sealed by heat with a seal strength stronger than that of the first seal portion.
Citation Information
Patent Citations
Container for freeze preservation and method of freeze preservation
JP2007302567A