JP2002335950A - Storage / transport container and storage / transport method for membrane tissue - Google Patents

Abstract

(57) [Summary] [PROBLEMS] To maintain biological activity without impairing biological properties of a flat membrane-like membrane tissue made of a biological material while maintaining its original shape, A storage / transport container for a membrane tissue that is easy to pack, store, and transport such a membrane tissue and that is easy to handle, such as taking out the membrane tissue, and storage of a membrane tissue using such a storage / transport container. / Providing transportation methods. SOLUTION: A storage / transport container for a membrane tissue (12) is sandwiched from both sides of a flat membrane-like membrane tissue (12) made of a biological material, and has a biological property in a state where the original shape is maintained. A liquid-permeable support (34) configured to be able to be retained without impairing the liquid and at least one of the supports is accommodated together with a predetermined storage / transport liquid (14), and the storage / transport liquid (14) is stored. An openable liquid-tight and / or air-tight container body (2) adapted to keep said membrane tissue (12) held in said support (34) in a moist state at 14).
6).

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

TECHNICAL FIELD The present invention relates to a storage / transport container for membrane tissue and a method for storing / transporting such membrane tissue.
In particular, in a state where the original shape of a flat membrane-like membrane tissue made of a biological material is maintained, its biological activity is maintained, and the packaging (packaging), storage, and transportation of such a membrane tissue is simple, and The present invention relates to a container for storing or transporting a membrane tissue which is easy to handle, and a method for storing or transporting a membrane tissue using such a storage or transport container.

[0002]

BACKGROUND ART In general, the present invention is applied to defective wounds such as burns, wounds, pressure ulcers, abrasions, ulcers or birthmarks, bruises, tattoos, after scar removal, laser ablation, etc., to promote the healing of these defective wounds. Membrane tissue used for examining irritation to the skin and toxicity of drugs, etc.
Mucosal epithelial tissue, corneal epithelial tissue, cultured skin, cultured dermis, cultured epidermal cell sheet, cultured epithelial tissue, cultured corneal tissue, etc., all of which are known to have very thin film thickness ing.

[0003] More specifically, among those biological tissue membrane tissues, particularly in the case of a cultured cell sheet tissue, a single cell membrane of a cultured epidermal sheet: about 0.01 mm, and a single cell membrane of a corneal epithelium: about 0.1 mm. 01 mm, the thickness of the culture skin sheet is extremely thin, and even if the culture skin sheet is composed of multiple cell layers, the 3-cell layer culture skin sheet: about 0.05 to 0.06 mm, the 5-cell layer culture skin sheet: about 0. 08 mm, and even in the skin tissue (the combination of the epidermis layer and the dermis layer), when the film thickness is thin, it is very thin, about 0.2 mm. Further, the membrane tissue made of such a biological material is not only thin but also has poor mechanical strength and is very fragile. Are very difficult to handle), and when they are picked with tweezers or the like and transported to a defective wound surface, they are easily broken by their own weight. For this reason, conventionally, in order to protect or retain such a membrane tissue, a substrate (backing substrate) such as a gauze or a wound dressing material has been used.
Is backed by such a membrane tissue, thereby reinforcing the membrane tissue and facilitating the handling thereof. It was extremely thin, 1.5 mm.

There are various problems inherent in fixing a membrane having a thickness of several tens of μm to several hundreds of μm on a backing substrate such as the above-mentioned gauze or wound dressing material. For example, as a fixing method, generally, a method using a medical stapler, a suture, a needle, or the like can be considered, but when the membrane tissue is fixed to the backing substrate according to such a fixing method, the membrane tissue is broken. Therefore, it was very difficult to fix the membrane tissue to the backing substrate, and in actuality, it was necessary to fix the membrane structure to the backing substrate with water such as a medium or a buffer solution.
In addition, a method of fixing using a medical adhesive (fibrin or the like) has also been proposed.
In addition to the loss of biological activity of the membrane tissue, there are problems that it is difficult to remove the membrane tissue before use such as surgery, it is troublesome, and the problem is that the cost becomes extremely high. It was.

Under these circumstances, at present, a flat membrane structure composed of a biological material is backed by a base material such as a gauze or a wound dressing as described above, and its biological activity cannot be impaired. As described above, in a container such as a commercially available round Petri dish or square Petri dish containing a liquid medium, a buffer, a physiological saline solution, and the like, the backing substrate is housed on the lower side,
Then, it is pre-packaged and stored or transported to a medical institution or the like. When exposed, it comes to float away from the backing substrate, and as a result, the membrane structure is broken, twisted, the front and back are reversed, etc. A container such as a petri dish is not liquid-tight and has poor airtightness, so that the liquid in the container is liable to leak out, and there is a risk of microbial contamination. For this reason, before the membrane tissue is used, the membrane tissue is broken or twisted,
There is an urgent need to develop a storage / transport container having excellent liquid tightness and / or air tightness, which can maintain its original shape and maintain biological activity without inversion.

[0006] Here, as a container / method for storing or transporting such a membrane tissue, see Japanese Patent No. 29/29.
Japanese Patent No. 04807 describes an inner bag and a middle bag in which a gas-permeable and bacteria-impermeable material is used for at least a part of a constituent material, and an outer bag made of a metal foil material coated or laminated with a heat-adhesive resin. A package having a triple structure was proposed, which was able to effectively eliminate the problem of microbial contamination. Deformation such as breakage or twisting of the artificial skin in the bag is easily caused, and the problem of difficulty in maintaining the shape of the artificial skin has not been solved. For this reason, there is a problem that the damage is caused, the biological activity is reduced, and the removing operation cannot be performed with the tweezers, becomes complicated, and the damage is easily caused during the operation. .

Further, Japanese Patent Application Laid-Open No. H8-23968 discloses that
A method for storing and transporting cultured skin in which the cultured skin is placed in a gelatin solution that has been heated to a sol, and then the temperature is lowered and gelled. Has been proposed,
In the case of extremely thin membrane tissue as described above, there is a great risk of damaging the membrane tissue by simply removing it from the gelatin gel. Because of the risks, after taking out from the gelatin gel, very complicated washing operations requiring instruments and personnel have to be repeated, and this is a very difficult method to handle in medical settings such as operating rooms. is there.

[0008] Further, Japanese Patent No. 2733800 discloses a skin wound dressing composed of a flat sheet (cell sheet) and a liquid impervious closed bandage formed by engaging first and second packaging materials. A package configured to be supported on the surface of the support has been proposed, but even this does not solve the problem of the cell sheet being broken or twisted, and still has an adhesive property. The cell sheet clipped to the substrate sheet (gauze infiltrated with petroleum jelly: petroleum gauze) drops off from the petroleum gauze due to the shearing force of the culture solution during transportation, and the front and back of the cell sheet are removed. It is not clear which side has a germinative layer to be brought into contact with the wound surface, and it is also impossible to handle with tweezers, which may cause damage. Is are you.

More specifically, Japanese Patent No. 27338 is disclosed.
In the specification of Patent No. 00, it is considered that the cell sheet is easily taken out by adhering and transporting the cell sheet with an adhesive substrate sheet, that is, petroleum-based gauze. Because the gauze has high water repellency and cannot adhere well to cells, it improves the phenomenon such as "the epithelium falls off the vaseline gauze lining due to the oscillating shear force of the culture solution during transport". However, in the examples, the cell sheet is clipped to the petroleum-based gauze to thereby prevent the cell sheet from being detached from the petroleum-based gauze. Also, even if it does not lead to detachment, during transportation, in a solution such as a medium, the center of the cell sheet floats or cracks,
In addition, since the cell sheet composed of only cells is very fragile as described above, local mechanical stress of clipping is applied, thereby causing breakage at the clip-clamping site and causing biological damage. Such clipping requires that very fragile cell sheets have to be fastened against the adherent substrate sheet under aseptic conditions, which can result in at least partial loss of biological activity, which is a very cumbersome task. It becomes. Furthermore, the petroleum component of petroleum-based gauze remains on the cell sheet,
There is also a risk that the normal physiological and biological activities of the cell sheet will be adversely affected. Moreover, in such a package, when a plurality of cell sheets are put in one package, the most important germination layer of the cell sheet comes into contact with the adhesive substrate sheet such as petroleum-based gauze. However, there is also a problem that the biological activity of the cell sheet placed below is lost, so that only one cell sheet can be put in one package, and therefore, the number of packages equal to the number of epidermal cell sheets There is also a problem such as the need for

[0010]

Here, the present invention has been made in view of such circumstances, and a problem to be solved is to provide a flat membrane structure made of a biological material, which has an original shape. In the retained state, the biological activity is advantageously retained without impairing the biological properties, and the packaging, storage, and transportation of the membrane tissue are easy, and handling such as removal of the membrane tissue is easy. It is an object of the present invention to provide a storage / transport container for various membrane tissues and a method for storing / transporting a membrane tissue using such a storage / transport container.

[0011]

The present invention has been made to solve the above-mentioned problems, and the gist of the invention is to sandwich a flat membrane-like membrane tissue made of a biological material from both sides, A liquid-permeable support configured to be able to maintain the biological shape without impairing its biological properties, and one or more of the supports may be stored in a predetermined storage /
An openable liquid-tight and / or air-tight container body housed with a transport liquid and adapted to be able to maintain said membrane tissue held by said support in said storage / transport liquid in a wet state. A storage / transport container for membrane tissue, characterized in that:

[0012] In short, in the storage / transport container for a membrane tissue according to the present invention, a flat membrane-like membrane tissue made of a biological material is formed on both sides thereof by a predetermined support. Since the membrane tissue is sandwiched by an appropriate clamping force that does not cause damage, the membrane tissue can be held in a fixed position without being displaced from the support, and the biological activity of the membrane tissue is impaired. Even in a predetermined storage / transport solution that is used so as not to be able to be removed, such a membrane tissue is detached, floated, broken, twisted, or turned upside down, so that the original shape cannot be maintained. Can be eliminated.

In addition, since the above-mentioned support has liquid permeability, the storage / transport liquid can be constantly supplied to the membrane structure sandwiched between the supports. Problems such as death of cells constituting the tissue and opening of a hole in the membrane tissue can be effectively prevented.

Further, in the storage / transport container according to the present invention, one or more of the above-mentioned supports and a predetermined storage / transport liquid are accommodated together, and the storage / transport liquid is used for the storage / transport liquid. Since the openable container main body capable of maintaining the membrane tissue held by the support in a wet state is liquid-tight and / or air-tight, the storage / containment stored in the container is It has features such as no leakage of the transport liquid and no risk of microbial contamination.

According to one preferred embodiment of the storage / transport container for a membrane tissue according to the present invention, the support is made of a sponge, a nonwoven fabric, a woven fabric, a mesh, a film or a film. A configuration in which at least one of the support members in the form of a sheet or a plate is used, and the membrane tissue is gripped from both sides by the at least one support member, can be suitably adopted.

According to another preferred embodiment of the present invention, the support is constituted by two of the support members, and corresponding sides of the two support members are bonded, fastened, The membrane can be gripped between the two support members by being connected by a connecting means selected from the group consisting of a hook-and-loop fastener, a thread, a needle, and a hinge. By adopting such a configuration, a shift occurs between the two support members,
It is possible to effectively prevent the membrane tissue gripped or sandwiched from being broken or twisted and broken, thereby effectively maintaining the original shape of the membrane tissue.

In addition, according to another preferred embodiment of the storage / transport container for the membrane tissue according to the present invention, the support is constituted by three of the support members, and the three support members are provided. Are connected by a connecting means selected from the group consisting of an adhesive, a fastener, a hook-and-loop fastener, a thread, a needle-like object, and a hinge to form a three-fold structure, and the three support members having the three-fold structure The membrane tissue may be grasped in between. By adopting such a configuration, the original shape of the membrane tissue grasped or sandwiched between the support members can be extremely advantageously retained.

Further, according to another preferred embodiment of the present invention, the support is constituted by a thick plate-like sponge body, and the sponge body has a thicker sponge body. By making cuts in parallel directions, the membrane tissue is inserted into the cuts and can be pinched. In this manner, by allowing the membrane tissue to be grasped at the cut site, the support member that sandwiches the membrane tissue does not shift at all on both sides of the membrane tissue, and thus the membrane sandwiched therebetween. Breakage or breakage of the tissue, such as by twisting, can be advantageously prevented.

In addition, according to a further preferred embodiment of the storage / transport container for the membrane tissue according to the invention, at least one surface of the support contacting the membrane tissue comprises:
It is desirable that the membrane is water-repellent, so that the membrane tissue can be advantageously prevented from sticking to the contact surface with the support. It is easy to remove the tissue.

Also, according to the present invention, a method for preserving a membrane tissue
According to another preferred embodiment of the transport container, the support has a protrusion for physically fixing the membrane tissue,
It is desirable to have on the surface on the side facing the membrane tissue, and by adopting such a configuration, even if an external force is applied to the support, stress on the membrane tissue gripped during that time, The film structure can be held sufficiently and its movement can be suppressed while sufficiently relaxing the film structure to such an extent that the film structure is not damaged.

Further, according to another preferred embodiment of the present invention, the container body is provided with the support and the storage / maintenance unit.
It comprises a box-shaped container for storing the transport liquid, and a lid member for closing the opening of the box-shaped container in a liquid-tight and / or air-tight manner.

According to one preferred embodiment of the storage / transport container according to the present invention, it is desirable that the membrane is supported by being backed by a predetermined base material.
This reinforces the membrane structure and facilitates its handling.

Furthermore, the storage / transport container according to the invention is preferred.
According to one more preferred embodiment, the storage / transport solution is
Liquid medium, physiological saline, or isotonic solution
It will be. This allows for packaging in storage / transport containers
The biological properties of the membrane tissue
It can be maintained.

[0024] In addition, according to another preferred embodiment of the storage / transport container for membrane tissue according to the present invention, the membrane tissue is cultured skin, and the membrane tissue is cultured epidermal cells. It is a sheet or a cultured epithelial cell sheet. By targeting such a membrane structure, the features of the present invention can be better exhibited.

The present invention also provides a storage / transport container for a membrane tissue as described above, wherein the biological activity is maintained while the membrane tissue is kept in its original shape by sandwiching the membrane tissue between the supports. The gist of the present invention is also a method for storing / transporting a membrane tissue which is stored or transported while being stored. That is, in the method for storing / transporting a membrane tissue according to the present invention, since the storage / transport container for the membrane tissue having the above-described configuration is used, the original shape of the membrane tissue can be advantageously maintained. As much as possible, their biological properties are not impaired and their handling is easy. In addition, a plurality of membrane tissues can be packed (packed) in a single container since the membrane tissue is gripped from both sides by the support, and the number of steps and cost can be reduced. is there.

[0026]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, in order to clarify the present invention more specifically, embodiments of the present invention will be described in detail with reference to the drawings.

First, FIG. 1 schematically shows an embodiment of a storage / transport container for a membrane tissue according to the present invention in a vertical cross section. There, 10
Is a container for accommodating the membrane tissue 12 and the preservation / transportation liquid 14, and the bottom wall portion 1 having a rectangular corner chamfered.
6 and a rectangular cylindrical side wall portion 18 integrally provided at a predetermined height from the bottom wall portion 16, and has a box-like shape. / The transport liquid 14 can be accommodated and sealed.

On the outer periphery of the upper opening 20 of the container 10, a thin flange portion (flange portion) 22, which protrudes outward by a predetermined dimension and extends continuously in the circumferential direction, is provided integrally. I have. Then, a film-like lid member 24 is adhered to the upper surface of the flange portion 22 of such a container 10 by various conventionally known methods, so that the upper opening 20 of the container 10 is covered and closed. The container 10 and the cover member 24
Thus, the container body 26 is configured.

As described above, the container main body 26 has liquid tightness and / or air tightness, and the membrane space 12 and the storage / transport liquid 14 are accommodated in the internal space thereof, whereby The membrane tissue 12 can be kept moist,
Its biological activity is not lost.

Here, the membrane tissue 12 housed in the storage / transport container for membrane tissue according to the present invention and subjected to storage and transport includes burns, wounds, pressure sores, abrasions, ulcers or nevus. It is applied to defective wounds such as after bruises, tattoos, scar removal, laser ablation, etc., and is used to promote the healing of these defective wounds, and to examine skin irritation, chemical toxicity, etc. A membrane structure, particularly a flat membrane structure made of a biological material, can be exemplified.

Specifically, examples of the membrane tissue 12 composed of such a biological material include skin tissue, mucosal epithelial tissue, corneal epithelial tissue, cultured skin, cultured dermis, cultured epidermal cell sheet, cultured epithelial tissue, and the like. Cultured corneal tissue and the like can be mentioned. Here, the cultured skin is a culture of epidermal cells (keratinocytes) obtained from the epidermis of a mammal,
Proliferated epidermal cell sheet, epithelial cell sheet obtained by culturing and growing mucosal epithelial cells obtained from mucosal epithelium, corneal epithelial sheet obtained by culturing and growing corneal epithelial cells obtained from corneal cells, fibroblast obtained from dermis After the cells were cultured and propagated, biologically-derived polymer materials, such as collagen, fibrin, laminin, and cultured dermal-like ones incorporated in gelatin and the like, and the cultured dermal-like epidermal cells were incorporated therein. It refers to a conventionally known cultured skin such as a cultured skin.

Then, various membrane tissues 12 as described above are used.
Is very thin and fragile, especially in a membrane tissue of less than about 0.1 mm, it is difficult to handle freely when operating with tweezers or the like, and it may break, twist, Since it is difficult to maintain the original shape because it is easily broken, and because it has a bad influence on the biological activity, generally, as shown in FIG. Is backed (backing substrate 28). In this manner, by being held and fixed to the backing substrate 28, the membrane structure 12 is reinforced and handling thereof is facilitated. In FIG. 1 and FIGS. 2 to 7, 9 and 11, which will be described later, the thickness of the film structure 12 and the backing substrate 28 are exaggerated so that they can be easily understood. It is to be understood that the figures are shown in larger ratios.

It should be noted that such a backing substrate 28 can hold and fix the membrane tissue 12 and has good biological safety, in other words, the biological Substrates made of a material that does not adversely affect the properties can be suitably adopted, for example, gauze, or a bio-derived polymer material such as collagen, chitin, chitosan, or the like, a sheet, a sponge, a woven cloth, or the like. A nonwoven fabric base material or a base material made of a water-absorbing material such as a synthetic polymer material such as polyvinyl alcohol, polyHEMA (poly-2-hydroxyethyl methacrylate), polyacrylamide, and poly-N-vinylpyrrolidone are exemplified. I can do it. Further, in addition to the above, a nonwoven fabric-like base made of a synthetic polymer material having hygroscopicity and moisture permeability, dry animal skin, cellulose, and the like can also be used.

The backing substrate 28 is fixed to the membrane 12 by a conventionally known method, and is subjected to packaging, storage, transportation, and the like together with the membrane 12. However, it is usually removed after using the membrane tissue 12, for example, after the membrane tissue 12 is applied to the wound surface. For this reason, the backing substrate 28 is generally attached to the surface of the membrane tissue 12 opposite to the surface to be adhered to the living tissue such as the wound surface (the surface to which it is applied). Has a backing substrate 28 on the surface opposite to the adherent cell surface (basal cell layer).
Is attached. Thereby, the membrane tissue 12
Therefore, the biological activity in the application aspect can be advantageously maintained.

It is to be noted that such a backing substrate 28 is not necessarily required when using a film structure that is easy to handle, such as a film structure having good shape stability even though it is thin. It is appropriately adopted according to the characteristics. Further, the shape, size and thickness of the backing substrate 28 are not particularly limited as long as they can be easily handled using an instrument such as tweezers.
Will be determined appropriately according to the size, type, etc.

However, not only the film structure 12 alone, but also the film structure 1 on which the backing substrate 28 is backed as described above.
2, the membrane tissue 12 is still vulnerable. Therefore, when such a membrane tissue 12 is stored as it is in the container body 26 containing the storage / transportation liquid 14, as described above,
The membrane structure 12 is detached from the backing substrate 28, floats, and is broken, twisted, or turned upside down, so that the original shape cannot be maintained. Further, the membrane structure 12 is damaged. Such a problem is caused. For this reason, in the storage / transport container according to the present embodiment, FIG.
As shown in FIG. 2, the membrane structure 12 (hereinafter, referred to as a membrane structure sheet 30) fixed to the backing substrate 28 further includes
It is held by a support 34 made of a sponge-like support member 32.

Specifically, as shown in FIG. 2 (a), the support 34 is made of a thick-plate-shaped bio-derived polymer material or synthetic polymer material having an area larger than the membrane sheet 30. The sponge body (sponge-like support member) 32 is formed in a thick portion of the sponge body 32.
Cuts 36 are made in a direction parallel to the plate surface so as to divide the thickness into two.

Then, in the cut 36, the membrane tissue sheet 30 is placed so that the sides on both sides thereof and the holding surfaces 38, 38 are opposed to each other at the open end side of the cut 36 (FIG. 2A).
By inserting from the right side), both surfaces of the membrane tissue sheet 30 are respectively held by the holding surfaces 38, 38 of the sponge body 32.
2 and is fixedly held in a state where the original shape is maintained (FIG. 2).
(B)). In this way, the membrane 12 has a flat clamping surface 3.
Since the film is sandwiched between the support members 8 having the structure 8, the load is uniformly applied to the entire membrane structure 12, and a local load is not applied. Further, a metal fastener 40 is attached to the sponge body 32 so that the membrane tissue sheet 30 does not fall out of the cut end 36 of the sponge body 32 at the open end of the sponge body 32. The body 32 is attached so as to surround at least the open end (the right end in the figure).

Further, as described above, the membrane tissue sheet 30
As shown in FIG. 2 (c), the support 34 is inserted into the container 10 together with the storage / transport liquid 14, and the upper opening 2 of the container 10.
As a result, the membrane tissue 12 is held in the storage / transport container in a state where the membrane tissue 12 keeps its original shape by closing the liquid tightly and / or airtightly by the lid member 24 (FIG. 1).

That is, in the storage / transport container for a membrane tissue according to this embodiment, the flat membrane-shaped membrane tissue 12 is used.
However, the membrane tissue 12 is displaced from the support 34 by the support 34 made of the sponge body 32, which is sandwiched and held from both sides by an appropriate clamping force that does not damage the membrane tissue 12. In addition, the membrane structure 12 can be held in a fixed position without being disturbed, and in the preservation / transportation liquid 14, the membrane tissue 12 is detached, floats, bends, twists, or reverses the front and back sides, and retains the original shape. And the occurrence of problems such as damage to the membrane tissue 12,
It can be advantageously avoided.

Moreover, in this storage / transport container,
From the place where the membrane tissue 12 is sandwiched by one support member 32, that is, a cut 36 is provided in the sponge body 32 which is the support 34, and the membrane tissue 12 is gripped at the cut 36 site. From where you are
There is no relative displacement between the reference numerals 8 and 38, so that the original shape of the membrane 12 sandwiched therebetween can be maintained very advantageously. As described above, since the membrane tissue 12 is protected on both sides by the sponge body 32, rough transportation to such an extent that the support body 34 is not damaged, for example, rough handling is not limited to rough handling. Therefore, it is possible to sufficiently withstand the transportation of the vehicle, the severe shake of the airplane, or the drop during transportation.

In addition, in the storage / transport container (container main body 26), a predetermined storage / transport solution 14, for example, an isotonic solution such as a liquid medium, physiological saline, or a buffer solution is put in an appropriate amount. Since the support 34 made of the sponge body 32 having excellent liquid permeability is used, the preservation / transport liquid 14 can always be supplied to the membrane 12 sandwiched between the supports 34. As a result, the cells constituting the membrane tissue 12 are killed,
2 can be effectively prevented from occurring, and the container main body 26 is liquid-tight and / or air-tight. There is no danger of liquid 14 leakage or microbial contamination.
The biological properties of the membrane tissue 12 can be maintained very well and over a longer period.

Incidentally, the support employed in the present invention comprises:
The present invention should not be interpreted as being limited to only the structure of the support 34 in the above example, and various modifications can be made without departing from the spirit of the present invention.

For example, as the support, as described above,
It is possible to maintain the original shape without impairing the biological characteristics of the flat membrane-shaped membrane tissue 12 having a thickness of several tens μm to several hundred μm and sandwiching the membrane tissue 12 from both sides. For example, the material, form, shape, size, and thickness are not particularly limited, and can be appropriately selected and adopted according to the membrane structure 12 to be stored or transported.

Specifically, examples of the material of such a support (or a support member as a constituent member of the support) include paper, metal, plastic, and bio-derived polymers. Examples thereof include those processed into a sponge shape, a nonwoven fabric shape, a woven fabric shape, a mesh shape, a film shape or a sheet shape, or a plate shape. Further, as the size of the support (supporting member), generally, a size having a size including the entire membrane tissue 12 is preferable, but if holding is possible, a size including the membrane tissue 12 is preferable. Even if you do not have one, you can do anything. The support employed in the present invention may be composed of the same material or form of the support member, or may be composed of a combination of different material or form of the support member.

The membrane 12 sandwiched between the supports is
Since it is necessary to maintain the moist state in the storage / transport liquid 14, such a support has a membrane structure 1 sandwiched therebetween.
Liquid permeability is always required so that the storage / transport liquid 14 can be sufficiently supplied. Furthermore, the support is
One that can hold the membrane tissue 12 in a fixed position even in an environment immersed in the storage / transport solution 14, that is, a support that is disposed on both sides of the membrane tissue 12 even when immersed in the storage / transport solution. It is necessary that the members have a structure that does not shift or separate. This is because the support members disposed on both sides of the membrane tissue 12 may be displaced, and the membrane tissue 12 may be damaged. Therefore, in the support,
In a configuration in which the two surfaces in contact with both surfaces of the membrane tissue 12 do not shift, for example, in the case where the support is composed of two support members, the corresponding at least one side portion of the two support members is connected to each other. , Etc., are preferably adopted.

FIGS. 3 to 6 show other different examples of the support which satisfies the above-mentioned various conditions. In FIGS. 3 to 6, members and parts having the same structure as the above-described embodiment are described.
In the drawings, the same reference numerals as those in the above-described embodiment denote the same components, and a detailed description thereof will be omitted.

That is, first, FIG. 3 shows a perspective view in an open state and a side view in a closed superposed state of a support 42 having a structure different from the above-described embodiment, as (a) and (b), respectively. Shown schematically. In FIG. 3, the support 42 is composed of two mesh-shaped support members 44 having a substantially rectangular shape. The support members 44 are made of metal, synthetic polymer (plastic), or the like. A plastic mesh (mesh) -like sheet 48 having an area larger than the membrane structure 12 is attached to a rigid, substantially U-shaped frame body 46. The ends 50, 50 on the opening side in the U-shape of the two frame bodies 46 are rotatably supported around the shaft member 52 and are not pivotally supported. Therefore, such a support member 44
The two support members 44, 44 are connected by a hinge mechanism which enables the rotation of the support member 4 around the shaft member 52.
2 are constituted.

Then, the supporting members 4 connected to each other
The overlapping surfaces (opposing surfaces) of the layers 4 and 44 are sandwiching surfaces 54 and 54 for sandwiching the membrane tissue sheet 30, respectively. The membrane tissue 12 (membrane tissue sheet 30) is arranged.

Further, knobs 56 are attached to the sides of the support members 44, 44 opposite to the connection side, respectively, and as shown in the figure, the support members 44, 4 arranged vertically.
4 are engaged with each other, so that the relative movement of the two support members 44, 44 becomes impossible, and the membrane tissue sheet 30 sandwiched between them becomes impossible.
However, in a state where the original shape is maintained, the position is fixedly supported.

That is, in the support member 42 according to this embodiment, the two support members 44, 44 are connected in a foldable manner by the hinge mechanism, and a film is provided between the two support members 44, 44. Since the tissue 12 is sandwiched between the two support members 44, 44, no displacement occurs, and therefore, the membrane tissue 12 sandwiched between the two support members 44, 44 does not occur.
Can be maintained very advantageously.

In the above-described support member 42, the corresponding one sides of the two support members 44, 44 are connected to each other by a hinge mechanism, but such a connection method is conventionally known. Various methods can be adopted, and, for example, examples of the connection means include an adhesive, a fastener (for example, a clip), a hook-and-loop fastener, a thread, and a needle-like material.

When the support 42 according to this embodiment is employed, since the support 42 is formed of the mesh-like support member 44, the membrane tissue sheet 30 is sandwiched between the supports 42. In a state where the membrane 1
There is also an advantage that the washing operation 2 can be performed. That is, when the membrane tissue 12 is, for example, an animal-derived cell sheet, blood components and the like are attached, and when the membrane tissue is cultured skin, serum and the like are attached. It is necessary to perform the cleaning operation. In this case, if the cleaning operation is performed while being sandwiched between the supports 42, there is an advantage that the damage of the membrane tissue 12 can be advantageously avoided.

On the other hand, FIG. 4 schematically shows a perspective view and a side view of a support 58 having a structure different from the above example as (a) and (b), respectively. There, the support 58 is composed of support members 60, 62, 64 made of three rectangular plastic sheets,
They are connected and overlapped to form a three-fold structure. The upper surface of the support member 60 is a mounting surface on which the membrane tissue sheet 30 is placed, and has a larger planar area than the membrane tissue sheet 30. Further, at one end in the width direction, a corresponding one end in the width direction of the rectangular support member 62 having a smaller width dimension than the support member 60 is connected by a stapler, while the other end in the width direction is connected to the other end in the width direction. , The support member 6 having a size slightly smaller than the support member 60 (the size in the left-right direction in the figure).
4 at one end in the width direction are stapled, so that three support members 60, 62,
64 are interconnected.

Then, the membrane tissue sheet 30 is placed on the upper surface of the support member 60, and the support members 62 and 64 are overlapped on the membrane tissue sheet 30, whereby the membrane tissue sheet 30 is placed. However, the support members 60, 62,
At 64, the position is fixed.

In short, in the support member 58 according to the present embodiment, the three sheet-like support members 60, 62, and 64 are connected to each other by connecting means (staplers).
A tri-fold structure is formed and their support members 6
Since the membrane tissue 12 is sandwiched from both sides at 0, 62, and 64, the original shape of the membrane tissue 12 to be sandwiched can be advantageously retained.

The support member 58 (support member 60,
62, 64) are provided with a circular liquid passage hole 66 for ensuring a sufficient flow of the storage / transport liquid 14 in order to maintain the membrane tissue 12 in a wet state. As in the case of the support 42, the membrane tissue sheet 3 is attached to the support 58.
It is possible to perform the washing operation of the membrane tissue 12 in a state where the zero is sandwiched.

The shape of the liquid passage hole 66 and the opening density thereof are not particularly limited.
As the shape of the liquid passage hole 66, various shapes such as an elliptical shape, a rectangular shape, a polygonal shape, and a linear shape can be adopted in addition to the circular shape described above. It can be set appropriately so that the strength of the body 58 is not extremely weakened. Further, the liquid passage hole 66 is formed in the membrane tissue 12 by the structure of the support body 58 so that the storage / transport liquid 14
Is not necessarily provided as long as it can be supplied sufficiently.

On the other hand, FIGS. 5A and 5B are a plan view showing a support 68 having a shape different from that of the above-described support in an open state and cross-sectional explanatory views showing the folded state, respectively. , (C). The support 68 is made of a bag 7 made of a water-absorbent nonwoven fabric.
0 is filled with a hydrophilic gel 72, and the membrane tissue sheet is folded in two at a fold line (A) so that one short side is aligned with the other short side. Thirty supports are formed, between which the membrane tissue sheet 30 is sandwiched. As a result, the membrane tissue sheet 30 is effectively held in the same manner as in the previous example.

Further, the support 74 shown in FIG. 6 has a case form having an opening / closing structure substantially similar to that of a flexible disk case or a compact disk case, in which a cover member having such a case form is provided. Support member 76 constituting the bottom member and lower support member 7 constituting the bottom member
The upper support 76 is rotatable about the shaft 80 so that the support 74 can be opened and closed. Further, on the upper surface of the lower support member 78, the membrane tissue sheet 30 is disposed such that the backing base material 28 constituting the membrane tissue sheet 30 is on the lower side, and the upper support member 76 is put on the membrane tissue sheet 30 to thereby form the membrane tissue sheet. The sheet 30 is sandwiched between the upper and lower support members 76 and 78.

The lower surface of the upper support member 76 is
As shown in (c), a plurality of protrusions 82 are provided integrally in a staggered manner. The protrusions 82 are formed by bonding a rubber foam (rubber sponge) having a substantially hemispherical shape to an upper support member 76 made of plastic, and have a high cushioning property. Thus, the upper support member 76 and the lower support member 78 constituting the support body 74 sandwich the membrane tissue sheet 30.
Even if an external force is applied between them, the pressing force on the membrane tissue sheet 30, particularly the membrane tissue 12, sandwiched between them can be effectively reduced. Therefore, the membrane tissue 12
Can be physically fixed without being damaged. In order to further reduce the load (pressing force) applied to the membrane 12 by the projection 82, the lower support member 78 is provided with a hole at a position corresponding to the projection 82. Is also possible.

Further, on the lower surface of the upper support member 76, a water-repellent film 84 made of a sheet made of fluororesin is stretched so as to cover the protruding portion 82. The surface is in contact with the membrane tissue 12. Since the surface in contact with the membrane structure 12 is made water-repellent in this manner, it is possible to advantageously avoid problems such as the film structure 12 sticking to the contact surface with the support 74. It is becoming. In addition, the water repellent film 84
Is made of a material to which the film structure 12 does not adhere or adhere. In other words, if at least one surface of the support that is in contact with the film structure 12 is made water-repellent, it is not limited to the above-mentioned fluororesin sheet. Rather, conventionally known various water-repellent coatings and water-repellent substrates are used, but in consideration of the simplicity and the effect on the film structure 12, etc.,
Fluororesin sheets are more preferably used.

The upper and lower supporting members 76 and 78 are provided with two types of engaging means in order to achieve the closed superposed state of the support 74 extremely advantageously. That is, the upper support member 7
6, a locking hole 75 provided at a predetermined distance from the shaft portion 80 in the direction of the opening end, and an engaging projection 77 provided on the lower support member 78 to be engaged with the locking hole 75. Thus, on the opening end side, an engagement recess 79 provided in the upper support member 76 and a lower support member 78 fitted in the engagement recess 79 are provided. And another engaging means is constituted by the engaging convex portion 81 provided on the second member. The two types of engaging means are engaged or fitted to each other, so that the upper supporting member 76 and the lower supporting member 78 are immovably and firmly connected to each other, so that the closed superposed state is extremely effective. It is realized in.

Although some of the supports suitably used in the present invention have been described above, they are merely examples, and the present invention is not limited to the specific description according to such embodiments. Is not to be construed as limiting in any way. In addition, for example, a support in the form of one mesh-shaped sheet folded in two or one end of two sponge bodies is attached to each other. The support, a support in a form in which one side of a case shape formed of a lid member and a bottom member is connected to each other using a hinge, a support in a form sandwiched between a pair of upper and lower nonwoven laminated fibers, and upper and lower support members of different materials. A support having a combined structure, for example, a lower support member made of a plastic sheet (flat plate) and an upper support member made of a mesh sheet, which are superimposed and connected to one side. Support or the state, with superposed two plastic sheets, support or the like form formed by bonding the one end portions, can be cited support various aspects.

In particular, when the support is formed of two or more support members, at least one corresponding side of the support member is connected to each other, so that the membrane tissue sheet 30 is formed.
As described above, it is possible to effectively prevent the occurrence of the displacement between the support members disposed on both sides of the other side, but more preferably, the other side that is not connected (the side on the opening end side). Part)
Also, after holding the membrane tissue sheet 30, it is preferable that the membrane tissue sheet 30 be connected or fixed with an adhesive, a fitting, a fastener, a hook-and-loop fastener, a thread, a needle-like material, etc., so that the handling is further simplified. It goes without saying that it will be.
In this connection, even if the side portions on the opening end side of the support are connected to each other, there is almost no influence on the membrane structure 12.

Further, the interval between the support members disposed on both sides of the membrane tissue 12 (sandwich interval) must be appropriately set according to the thickness and properties of the membrane tissue 12 to be used. It goes without saying.

Incidentally, similarly to the support described in detail above, the container body employed in the present invention is limited to the structure of the container body 26 having the structure shown in FIG. It is not to be construed in any way, and various modifications can be made without departing from the spirit of the present invention.

That is, as the container body, the membrane tissue 12
The material, shape, size, etc., of the material, shape, size, etc., are particularly limited as long as the material, liquid-tightness and / or air-tightness can hold the support sandwiching the film and can maintain the membrane structure 12 in a wet state. Not the support, the membrane or tissue 1 to be accommodated
According to the shape and size of 2, various conventionally known storage containers or transport containers can be appropriately selected and employed.

Specifically, such a container body is composed of a box-shaped container 10 having a flange portion (flange portion 22) and a film-like lid member 24 shown in FIG. Other examples include an aluminum pack, a plastic case, a metal case, a glass case, and the like. Further, a seal between the container and the lid member is provided by a seal ring to be liquid-tight and / or air-tight. Case, an infusion bag for thermocompression bonding of an aluminum or plastic bag, an aluminum bag, and the like.

For example, other examples of the container body are shown in FIGS. In FIGS. 7 to 9, members and portions having the same structure as the above-described embodiment are denoted by the same reference numerals as those in the above-described embodiment, and detailed description thereof will be given. Will be omitted.

First, FIGS. 7A to 7C show a container main body 9 composed of a plastic box-shaped container 86 and a lid member 88 for closing the opening of the box-shaped container 86.
Three different examples of zero are shown schematically. Here, in the container main body 90, both the box-shaped container 86 and the lid member 88 are sealed by the seal member 92, thereby achieving liquid tightness and / or air tightness. In the container main body 90 in FIG. 7A, the box-shaped container 86 and the cover member 88 are sandwiched and sealed by two U-shaped clamping fasteners 94, 94 made of a leaf spring. Further, the container main body 90 in FIG.
A male screw portion 96 provided on the upper outer peripheral surface of a box-shaped container 86 having a bottomed cylindrical shape and an inner wall surface of a lid member 88 having a bottomed cylindrical shape lower in height than the box-shaped container 86. The hermetically sealed by screwing with the provided female screw portion 98. Further, the container main body 90 in FIG. 7C is sealed by engaging an annular metal fastener 102 with a metal projection 100 fixedly attached to the lid member 88. . In short, any of various conventionally known structures can be applied for sealing the container and the lid member in the container body. Also, the size of the container body is not particularly limited, and as shown in FIG. 7, a size that can accommodate a plurality of supports, in other words, a plurality of membrane tissues 12 is used. Is also possible.

As described above, in the membrane tissue 12 stored or transported according to the present invention, both sides of the membrane tissue 12 are advantageously protected from being gripped or pinched by the support. This makes it possible for the first time to accommodate a plurality of membrane tissues in one container body. In addition, since a plurality of membrane tissues 12 can be accommodated, the amount of the storage / transport liquid 14 sealed in the container and the number of container bodies can be reduced, thereby reducing cost. In addition to the feature, it is possible to reduce the time and effort required to open the container body each time one of the membrane tissues 12 is taken out. Further, even when the membrane tissue 12 is washed in the container body, a plurality of membrane tissues 12 can be washed at the same time, which can greatly contribute to reduction in cost and labor.
In particular, when a cultured epidermal sheet is used as the membrane tissue 12, the culture epidermal sheet peeled off from the culture flask using an enzyme (dispase solution) has the dispase solution and the serum in the culture solution attached thereto. Therefore, it is necessary to wash when storing. The washing operation,
By carrying out in the container body, that is, the membrane tissue 12 to which the dispase solution or serum is adhered is gripped by the support, and a plurality of the supports are put in the container body and washed with physiological saline or the like. This makes it possible to remove the dispase solution and serum reasonably and easily.
Further, even when the membrane tissue 12 is cryopreserved, a plurality of membranes can be simultaneously frozen and thawed, the amount of the cryoprotective solution can be reduced, and washing at the time of thawing can be simultaneously performed on a plurality of membranes. .

On the other hand, FIGS. 8A and 8B are a longitudinal sectional view and a plan view, respectively, of the container main body 104 in which the support is stably fixed in the container. I have. In these figures, the container body 104 is
Has substantially the same structure as the container body 26 shown in FIG.
The up and down and left and right directions of the support are restricted by the cushion layers 106 and 108 provided with the air bag structure or the rubber cushion structure provided on the side wall portion 18 and the lid member 24, and the support is fixed. It can be held in.

FIG. 9 is a longitudinal sectional view showing another container body 110 in which the support is stably fixed in the container. The container body 110 includes a plastic housing 112 and a lid member 114, and the housing body 112 and the lid member 114 respectively have protrusions 116, 1 capable of holding the support body 34 in a fixed manner.
18 are provided facing each other, and the protrusions 116,
When the cover member 114 is overlaid on the container 112, the support member 34 is fixedly held in the container by abutting the support member 34 from above and below, so that the support member 34 in the container can be fixed. Movement is more effectively suppressed.

As described above, some of the container bodies suitably used in the present invention have been exemplified. Although the description is not to be construed as limiting in any way, the storage / transport liquid enclosed when removing the support holding the membrane tissue 12 in treatment in an operating room, a treatment room, a hospital room, etc. In the present invention, a structure such as a blister case in which the container is hardly scattered and the support is easily taken out, or a case in which the container and the lid member are liquid-tight, is preferably used. Also, save /
In order to further suppress the scattering of the transport liquid, a polymer gel, a bio-derived polymer gel, a woven fabric, a non-woven fabric, or other water-absorbing base material is placed on a portion of the container that does not directly contact the membrane tissue 12, It is also possible to make the inside of the container a humid environment. However,
The water-absorbing substrate used in this case may be a film structure 12
It is necessary to select one that does not reduce the activity.

By the way, when the membrane tissue is stored or transported by using the storage / transport container configured as described above, it is concretely performed according to, for example, the following method.

First, at a medical institution, normal skin near a human wound surface is disinfected, and about 2 cm ² thereof is collected in the form of a spindle. I do.
Next, the epidermal layer was collected with a dispase solution, immersed in a trypsin solution (manufactured by Invitrogen) to prepare an epidermal cell suspension, and thereafter, Rainwald and Green (Rheid).
nwald and Green) (US Patent No. 4016036)
No., JP-B-57-18863), in a culture flask, the respective epidermal cells from the primary culture to the fifth subculture are sheeted, and the epidermal cells are cultured and sheeted over the entire surface of the culture flask. Incubate continuously for 5 days.
Next, the medium was removed, and the cells were further washed with a phosphate buffer, and a dispase (joint sake refinement) solution was added. A chitin nonwoven fabric (lining substrate 28) (Vesquitin W: manufactured by Unitika Ltd.)
The epidermal cell sheet (12) is lined, and the epidermal cell sheet (12) is peeled from the culture flask. At this time, the entire backed chitin nonwoven fabric (28) is peeled off using tweezers or the like to prepare a membrane tissue sheet 30 composed of the chitin nonwoven fabric (28) and the epidermal cell sheet (12).

On the other hand, two rectangular plastic mesh sheets (upper sheet and lower sheet) having an area larger than that of the epidermal cell sheet (12) are prepared, and they are overlapped so that the corresponding one sides are made of plastic. Prepare a support that is connected by clips to open only on one side.

Then, the membrane tissue sheet 30 is sandwiched between the upper and lower sheets, and the unconnected open ends are fixed with plastic clips to fix the epidermal cell sheet (12) with the support. Pinch. In addition, on the lower surface of the upper sheet, an epidermal cell sheet (1
2), a fluororesin mesh sheet is arranged so as not to stick to the upper sheet.

Next, the support in which the epidermal cell sheet (12) is sandwiched as described above is housed in a blister case (box-shaped housing) having a brim around the opening. After washing the epidermal cell sheet (12) by injecting and draining water, a serum-free green medium is added. Then, after covering the entirety of the opening of the blister case with an aluminum sheet as a lid member, the sheet is thermocompression-bonded to the brim of the blister case, thereby closing the opening of the blister case in a liquid-tight manner. Packing.

Then, the storage / transport container containing the epidermal cell sheet as described above is stored or transported while refrigerated (2 to 8 ° C.) until the epidermal cell sheet (12) is used. You do it. And before use, room temperature (19
-25 ° C), or after keeping it warm in a warmer (30-37 ° C), take out the epidermal cell sheet (12),
Use it for its intended purpose.

Although the typical embodiment of the present invention has been described in detail, it is merely an example, and the present invention is not limited to any specific description of such an embodiment. It is to be understood that they are not to be construed as limiting.

For example, in the above embodiment (FIG. 6), the water-repellent film 84 made of a fluororesin sheet as the water-repellent substrate is used.
Is directly attached to the lower surface of the support member 76, and the surface of the support 74 that is in contact with the film structure 12 is made water-repellent. However, such a water-repellent substrate such as a fluororesin sheet is attached to the support member 76. It is not necessary to attach the support member 76 directly, and it is also possible to arrange it so as to be interposed between the membrane tissue 12 and the support member 76. Further, the support member 76 itself or at least the surface thereof is made of a water-repellent material. Alternatively, it is possible to provide a water-repellent surface by performing a water-repellent treatment. Of course, even with these configurations, the surface of the support that is in contact with the film structure 12 can be made water-repellent. It goes without saying.

It should be noted that, depending on the type of the membrane 12, some of the membranes 12 have a property that it is difficult to stick to the contact surface. When such a membrane 12 is stored / transported, In other words, the membrane structure 1 of the support 74
Water repellency on the surface in contact with 2 is not always required.

Further, in the embodiment shown in FIG. 1 or FIG. 2, the support 34 is constituted by a sponge body (support member) 32 having excellent liquid permeability.
In addition, the storage / transport liquid 14 can always be supplied. However, in order to further improve the liquid permeability of the support 34, as shown in FIG. It is also possible to provide a liquid passage hole 35 penetrating in the thickness direction. The size, shape, arrangement position, number of arrangement, and the like of the liquid passage holes 35 can be appropriately set as necessary, and are not particularly limited.

Further, as a support in the storage / transport container according to the present invention, the membrane tissue 12 (membrane tissue sheet 30) is used.
When grasping from both sides, the membrane tissue 12 (membrane tissue sheet 3)
0) is the distance between the two surfaces adjacent to each other,
A material designed to have a size similar to or close to the thickness of the (membrane tissue sheet 30) is preferably used. By using the support having such a configuration, the membrane tissue 12 can be extremely effectively prevented from being excessively pressed.

For example, in the above embodiment (FIG. 3), the knobs 56, 56 are engaged with each other, so that the two support members 44, 44 are connected to each other, and a strong closed polymerization state is realized. FIG. 11 is a vertical cross-sectional view in the closed polymerization state. There, the holding surfaces 54, 5 of the support 42
The distance D between the four is designed to be substantially the same as the thickness of the membrane sheet 30 in the closed polymerization state. In the case where the backing substrate 28 is not fixed to the film structure 12, in other words, when the backing substrate 28 is not used, the distance D between the sandwiching surfaces 54 is determined by the film structure. Needless to say, it is desirable to set the thickness so as to approach the film thickness of No. 12.

In the above embodiment, the application surface (the surface where the backing substrate 28 is not present and the biological activity is to be maintained) of the membrane tissue 12 is placed upward. According to the present invention, since both the upper surface and the lower surface of the membrane tissue 12 can be advantageously protected, there is no problem even if the membrane tissue 12 is placed so that the application surface thereof faces downward. Therefore, the outer surface of the support is, for example, “upper”, “UPSIDE”, “basal membrane side”, so that the user can easily recognize the application surface of the membrane tissue 12 gripped by the support. It is desirable that a mark such as “dermis side” and / or “lower part” be given.

The membrane tissue 12 is placed in the container so that it is located on the horizontal plane. However, according to the present invention, the membrane tissue 12 is oriented vertically according to the shape of the container body to be employed. May be accommodated. In other words, using the storage / transport container for membrane tissue according to the present invention, the original shape of the membrane tissue 12 can be advantageously retained even when the container is placed vertically.

Further, in the above embodiment, the membrane tissue 12 held by the support is accommodated in the container main body, and the membrane tissue 12 is washed in the container main body. Such cleaning need not necessarily be performed in the container body. Also, the timing of adding the storage / transport liquid to the container body is not particularly limited, and it may be added simultaneously with the membrane tissue 12 or before / after containing the membrane tissue 12 at all.

In addition, although not enumerated one by one, the present invention
Based on the knowledge of those skilled in the art, various changes, modifications, improvements and the like can be implemented in an aspect,
It goes without saying that all such embodiments are included within the scope of the present invention, without departing from the spirit of the present invention.

[0092]

Hereinafter, typical examples of the present invention will be described to clarify the present invention more specifically. However, the present invention is not limited by the description of such examples. It goes without saying that you don't receive anything.

Example 1 Two 10-cm × 15-cm rectangular plastic mesh sheets (10-mesh sheets) were overlapped, and one side thereof was connected with a metal clip.
Also, a cut portion is provided on one of the other side portions facing the other, and a claw portion which can be fitted into the cut portion is provided on the other side, and the claw portion is inserted into the cut portion, whereby the other portions are provided. A support used in the present example, which was configured so that sides could be engaged with each other, was produced.

On the other hand, epidermal cells collected from human skin are cultured and propagated in a flask to form a sheet. A backing was performed using a polyester-polyethylene non-woven fabric (manufactured by Unitika) having a size of 0.5 cm × 6.0 cm, and peeled from the flask. In addition,
The size of the culture epidermis sheet (12) is about 8.5 cm x
6.0 cm.

Next, the membrane tissue sheet 30 composed of the cultured epidermis sheet (12) and the polyester-polyethylene nonwoven fabric (28) is placed so that the basal cell layer of the cultured epidermis sheet (12) faces up, that is, the polyester The polyethylene mesh nonwoven fabric (28) is placed on the lower mesh-like sheet of the above-prepared support so that the non-fixed side faces up, and the upper mesh-like sheet is put on the lower mesh-like sheet. The other side of the lower mesh sheet was fitted. In addition, on the outer surface of the upper mesh sheet, "basal cell layer side" is specified so that the basal cell layer of the cultured epidermal sheet (12) can be seen. Since the cultured skin sheet (12) is easily attached to the upper part (upper mesh sheet) of the support, substantially the entire lower surface of the upper mesh sheet in contact with the cultured skin sheet (12) includes: A fluororesin mesh sheet was attached. As a result, the cultured skin sheet (12) did not stick to the upper portion of the support when the plastic mesh sheet on the upper portion of the support was lifted.

Then, the support holding the cultured epidermis sheet (12) is accommodated in a blister case (box-shaped container) having a brim around the opening, and the phosphate buffer solution is injected and discharged. After washing the cultured epidermis sheet (12), a green medium was added. Next, according to the present invention, a film as a lid member is hung on the opening of the blister case, and the film is thermocompression-bonded to the brim of the blister case to seal the opening of the blister case in a liquid-tight manner. The storage / transport container was completed.
Thereafter, such a storage / transport container is made in the same manner as before,
Transported to a medical institution. In the production of the above container,
On the lower surface of the film, a protruding portion projecting downward was partially formed so as to hold down the support. In addition, after the culture epidermal sheet (12) is peeled off from the culture flask and before being packaged and transported, it is 19.5 to 25.
After being stored at a temperature near room temperature of 26 ° C. for 26 hours, it was refrigerated (3 ° C. to 8 ° C.) and transported. The temperature was continuously measured by a thermo recorder ("Ondori" manufactured by T & D). In addition, the cultured epidermis sheet (12)
Before use, they were put in a high-temperature bath at about 35 ° C. in a medical institution, removed from the thermostatic bath at the time of use, and used.

Example 2 A polyethylene rectangle (about 12 mm thick) having a thickness of about 0.2 mm
A rectangular upper sheet A (approximately 3 cm × 9 cm) made of the same polyethylene is adhered to one of the short sides of the lower sheet of m.times.9 cm) with an adhesive. A rectangular upper sheet B made of polyethylene (about 9c
m × 9 cm) with an adhesive to prepare a support used in this example. Further, in these three sheets, holes having a diameter of 3 mm were provided at intervals of 1 cm in order to allow the culture medium to flow through the membrane tissue.

On the other hand, in the same manner as in Example 1, epidermal cells collected from human skin were cultured and propagated, and a cultured epidermal sheet (12) formed into a sheet in a culture flask was produced. Then, a nonwoven fabric made of chitin (Vesquitin W: manufactured by Unitika Ltd.) was placed as a backing substrate 28 on the cultured skin sheet (12) and peeled from the culture flask.

Thereafter, the membrane sheet 30 composed of the cultured epidermis sheet (12) and the nonwoven fabric made of chitin (28) is placed on the lower sheet of the prepared support, and the two upper sheets A, By covering B, the membrane tissue sheet 30 was gripped by the support. Next, two of the supports were placed in an infusion bag (Mita Rika Kogyo Co., Ltd.).
Housed. In addition, a small-diameter tube having a predetermined length is provided at one end of the infusion bag, and a large-diameter opening having a size that allows the support to be taken in and out is provided at the other end. Two of the above-mentioned supports were accommodated through the large-diameter opening. Then, about 2 cm from the end of the infusion bag on the side of the large-diameter opening was heat-sealed so that the opening could be easily opened during use.

After washing the culture epidermis sheet (12) together with the support by injecting and discharging physiological saline from the small-diameter tube of the infusion bag, a green medium is added, and the opening of the small-diameter tube is heated. Sealed and completed packaging. Thereafter, the cells were stored at 7.5 ° C. for 24 hours and transported to a medical institution by refrigeration. During transportation, a temperature environment of 2 ° C. to 8 ° C. was used using a cool box for transportation.

Example 3 A hydrophilic gel sheet (7 cm × 10 cm) in which a hydrophilic gel was filled inside a bag-shaped water-absorbent sheet through which water could flow.
Were vertically overlapped so that the center in the longitudinal direction was a fold, thereby producing a support having a two-fold structure used in this example.

At a medical institution, the skin (thickness: about 0.3 mm × length: about 30 mm) from the human abdomen using a razor
× width: about 45 mm) was thinly collected, and the collected skin was placed on a hydrophilic gel sheet below the support with the dermis side up. Next, after the upper hydrophilic gel sheets were overlapped, the other ends that were not connected were fixed with a medical stapler.

Thereafter, the support was placed in a rectangular aluminum bag (aluminum bag), and physiological saline was injected and discharged to wash the cultured epidermis. Then, glycerol was used as a cryoprotectant. DMEM (Dulbecco's modified Eagle minimum essential medium) containing 10% and 20% fetal bovine serum was added, and the opening was heat-sealed. The mixture was cooled from room temperature by about 1 ° C., ice-planted at a eutectic point temperature, and cooled and frozen to about −65 ° C. Thereafter, the cells were frozen and stored in liquid nitrogen for 2 weeks, and then transported to a medical institution in a frozen state at about -20 ° C. Then, the temperature was returned to room temperature at a medical institution, the aluminum bag was opened, physiological saline was injected and discharged, and the human skin was taken out and used.

Embodiment 4 An upper support member having a protrusion on the lower surface (inner surface) and a lower support member having a hole formed at a position corresponding to the protrusion of the upper support member. A styrene support body (97 mm long, 97 mm wide, 8 mm outside dimension, 8 mm inside dimension, in a closed polymerization state) in which the overlapping sides of the lower support member and the overlapping side are connected by a hinge mechanism.
5 mm). The protrusion is about 65m long.
Using rubber foam (rubber sponge) of m triangular prism,
It was provided by bonding one side of a triangular prism to the lower surface of the upper support member. In addition, the protruding portion was chamfered so that the apex of the triangle contacting the membrane 12 was not sharpened. Also, such a protrusion is about 4 mm
At a height of 10 mm, they were arranged in parallel in every 10 mm in the vertical direction. Further, the holes formed in the lower support member alleviate the stress exerted on the culture epidermis sheet (12) by the protrusions when the culture epidermis sheet (12) is placed and closed, and the culture epidermis sheet ( 12) to prevent the breakage, and at a position corresponding to the top side of the triangle of the protrusion attached to the lower surface of the upper support member, the width: about 3 mm x the length: 70 mm
The size was provided. Further, the upper support member was provided with a hole for facilitating the flow of the culture medium. Further, an engagement concave portion and an engagement convex portion are respectively provided on side surfaces of the upper support member and the lower support member facing the connecting portion. You can now close your body.

Then, the cultured epidermis sheet (12) with the backing substrate 28 produced in the same manner as in Example 1 is placed on the lower support member of the support so that its basal cell layer is on top. Then, the cultured epidermis sheet (12) was sandwiched from both sides by covering the upper support member. Next, this support is accommodated in a container body (tight box No. 5: manufactured by Inoui Seieido) in which the lid member and the container are hermetically sealed in a liquid-tight and / or air-tight manner via a seal ring. After washing by injecting and discharging a buffer solution, a green medium containing no serum was added, the plate was closed with a clasp, and transported to a medical institution.

After the culture epidermis sheet (12) was peeled off, it was allowed to stand at room temperature of about 18 ° C., stored at 15 ° C. for 24 hours, and transported at 2 ° C. in a portable cooler box.
The test was performed while maintaining the temperature at 8 ° C. Immediately before use, the cultured epidermis sheet (12) was taken out and used in a medical institution at a temperature of about 35 ° C. in a thermostat.

Example 5 A 1% collagen citrate solution derived from porcine dermis (manufactured by Kawaken Fine Chemical Co., Ltd.) was placed in a styrene container (No. 14 manufactured by Sunplatetech Co., Ltd.), and gelled under an ammonia atmosphere. After freezing at ℃, it was freeze-dried and irradiated with ultraviolet rays. This was prepared by electron beam sterilization. Thickness: about 1 mm × length: about 90 mm × width:
10 ⁴ human fibroblasts collected from human dermis and cultured and cultured were seeded on a collagen sponge-like sheet of about 90 mm in size, adhered and incorporated. Subsequently, a human cultured epidermal sheet prepared in the same manner as in Example 1 was set on the collagen sponge so that the basal cell layer was placed on the collagen sponge. (Collagen sponge + fibroblast + cultured epidermal sheet) was prepared.

On the other hand, thickness: 10 mm × length: 100 mm ×
A support according to Example 5 was produced by providing a cut in the middle part in the thickness direction of a 120 mm polyurethane foam (sponge) in a direction parallel to the plate surface so that the cultured skin could be inserted and arranged. Further, a mesh sheet made of water-repellent silicone (Trex Gauze: manufactured by Fuji Systems Co., Ltd.) was bonded to the surface directly in contact with the cultured skin sheet. Then open the cut sponge up and down,
After the cultured skin was placed on the lower sponge portion, the upper sponge portion to which the mesh sheet made of water-repellent silicone was fastened was covered. Then, the open ends of the sponge which were not connected were penetrated from the upper sponge to the lower sponge and then to the upper sponge with a bent plastic needle, and fixed.

Then, five of the above-mentioned supports were placed in a polypropylene container body (tight box No. 3: Inei Seiei Inuchi) in which the lid member and the container were hermetically sealed in a liquid-tight and / or air-tight manner via a seal ring. After washing and washing the cultured skin by injecting and discharging a phosphate buffer, a green medium was added, the lid was closed, and further closed with a clasp and transported to a medical institution.

Example 6 Two plastic mesh sheets (100 mesh sheets) each having a size of about 30 mm × 30 mm were overlapped with each other, and one end of each sheet was fastened with a stainless steel clip. Was prepared.

On the other hand, a rabbit cornea obtained from a rabbit eyeball was separated into an epithelium and a stromal layer using tweezers. After sterilization, the epithelial layer was cut into pieces by cutting it with scissors, and then attached to a 60 mm Petri dish (manufactured by Falcon) with the basal cell layer facing down, and a medium was added. The medium was replaced every three days, and the cells were cultured for 6 days. When the epithelial cells grew from the fragmented portion, the epithelial cells were collected with a trypsin solution, centrifuged, and the medium was added. Was prepared. This was inoculated into a 6-well petri dish (manufactured by Falcon), the medium was replaced every three days, and cultured to grow into a sheet. This was peeled from the well with a dispase solution, and the circumference was trimmed with a scalpel and medical scissors to a diameter of about 15 mm. Thereafter, the backing substrate 28 is applied to the rabbit corneal epithelial cell sheet (12).
Was backed using a polyester nonwoven fabric (made by Unitika).

Then, after placing the rabbit corneal epithelial cell sheet (12) on the lower mesh sheet of the support prepared above, the upper mesh sheet is covered, and the other end of the mesh sheet is further placed. They were fixed with a stapler. Since the rabbit corneal epithelial cell sheet (12) may adhere to the upper part of the support,
Approximately the entire lower surface of the upper mesh sheet was fixed with a fluororesin mesh sheet (manufactured by Inuchi Seieido). As a result, the rabbit corneal epithelial cell sheet (12) did not adhere to the upper part of the support when the upper mesh sheet of the support was lifted.

Next, the support sandwiching the rabbit corneal epithelial cell sheet is housed in a blister case (box-shaped housing) having a brim around the opening. After washing and injecting and discharging, DMEM medium was added. Further thereafter, a film as a lid member is hung on the opening of the blister case, and the film is thermocompression-bonded to the brim of the blister case, thereby closing the opening of the blister case in a liquid-tight manner. Transported to the building. Thereafter, it was opened in the animal operating room and used.

Comparative Example 1 A cultured epidermal sheet (12) produced in the same manner as in Example 1.
Vaseline-coated gauze (6 cm × 8 cm) is fixed as a backing substrate 28, and T75 (culture area: 75 c
m ² ) Removed from culture flask. This was housed in a square petri dish (manufactured by Nunc) with the backing substrate facing down, immersed in a green medium, and then sealed with parafilm at the opening of the petri dish and transported to a medical institution.

In a medical institution, a sterile cloth (compressen) or the like was prepared in the operating room and spread on the operating room wagon so as not to be dirty (aseptically). And
A sterilized stainless bat was placed on the sterilized cloth. Next, the cultured epidermis sheet (12) lined with gauze is taken out of the transported storage / transport container with sterile tweezers, spread on a stainless steel vat, and the backing substrate 2
The culture epidermis sheet (12) was picked up and used with 8 attached.

Comparative Example 2 According to the method described in JP-A-8-23968, first, 100 ml of DME + 5% serum medium was kept at 37 ° C.
10g of EOG sterilized bovine bone-derived gelatin powder
Was added, stirred and dissolved to prepare a 10% gelatin sol solution. Then, the cultured epidermis sheet produced in the same manner as in Example 1 was placed at the center of a square petri dish (made of a tank), and around this, 20 ml of the obtained gelatin sol was added. When this was left at room temperature (about 20 ° C.), it gelled after about 30 minutes, and the cultured epidermis sheet was fixed with jelly-like high-viscosity gelatin.

Comparative Example 3 A cultured epidermal sheet (12) produced in the same manner as in Example 1
After backing using petrolatum gauze (6 cm × 8 cm) as the backing substrate 28, it was detached from the T75 culture flask and taken out. After the petrolatum gauze and the cultured epidermis sheet (12) were fastened with a medical clip so that the basal cell layer was on top, this was accommodated in a blister case (box-shaped container) having a brim around the opening. The cultured epidermis was washed by injecting and discharging a phosphate buffer. Thereafter, a green medium was added, a film as a lid member was hung on the opening of the blister case, and then the film was thermocompression-bonded to the brim of the blister case, thereby closing the opening of the blister case in a liquid-tight manner. And transported to a medical institution in the same manner as in Example 1.

It is to be noted that 19.5 after the peeling of the cultured epidermis sheet (12) and before the transportation in the package, is performed.
After storing for 26 hours at an ambient temperature of about 25 ° C. to about 25 ° C., refrigerated transportation (3 ° C. to 8 ° C.) was performed. However, the measurement of the temperature was continuously performed by a thermo recorder ("Ondori" manufactured by T & D). Prior to use, it was placed in a thermostat at about 35 ° C. of a medical institution, and taken out and used at the time of use.

In Examples 1 to 6 and Comparative Examples 1 to 3 as described above, when the membrane structure was handled,
Evaluation of the ease of removal and the state (breakage, etc.) of the membrane structure after removal was performed as follows, and the results are shown in Table 1 below. -Easy to remove- A: Can be handled easily with fingers wearing tweezers or sterile gloves, and the storage / transport liquid does not spill. ：: Can be easily handled with fingers wearing tweezers or sterile gloves, but requires operation to discard storage / transportation liquid. Δ: Cannot be easily handled with fingers wearing tweezers or sterile gloves, requiring equipment and labor. ×: membrane tissue cannot be removed
Alternatively, it can be taken out but does not retain its original shape, and is accompanied by breakage. -State of membrane structure-A: Good. Δ: Partially damaged. ×: The original shape is not retained.

Table 1 also shows the number of helpers (separate from the user) required when using the membrane tissue.

Further, in order to examine the biological activity of the membrane tissue, the removed membrane tissue (cultured epidermal sheet or corneal epithelial sheet) was converted into single cells with a trypsin solution, and the viable cell rate (survival rate) of the membrane tissue was determined. It was measured by the trypan blue exclusion method, and the results are shown in Table 1 below.

[0122]

[Table 1]

As is evident from Table 1, the membrane structures according to Examples 1 to 6 stored / transported using the storage / transport container according to the present invention are easy to handle and can be used. It is recognized that the biological activity of the tissue is maintained at a sufficiently high level.

On the other hand, the storage /
With respect to the membrane tissue stored / transported in a transport container, the operation of removing the membrane tissue from the container is complicated, and the removed membrane tissue does not retain its original shape, and some of the membrane tissue may be lost, and may survive. It is also recognized that the rate is lower than that of the membrane structures according to Examples 1 to 6 above.

[0125]

As is apparent from the above description, in the storage / transport container for a membrane tissue according to the present invention, a flat membrane-like membrane tissue is sandwiched from both sides by a liquid-permeable support. ,
Since the support holding the membrane tissue is housed in a liquid-tight and / or air-tight container body that can be opened together with a predetermined storage / transportation liquid, a normal storage / transportation process is performed. In, such a membrane tissue can be effectively held in place without being displaced from the support,
Even in a predetermined storage / transport solution, such a membrane tissue is detached from the support and floats, and is broken, twisted, or turned upside down. That is, it is possible to effectively prevent deterioration of the characteristics. In addition, a plurality of membrane tissues can be packaged in one container, and furthermore, packaging can be performed easily, and there is an advantage that handling such as a removal operation at the time of use becomes easy. It is.

Further, in the method for storing / transporting a membrane tissue according to the present invention, the storage / transport container for the membrane tissue described above is used, so that the original shape of the membrane tissue can be advantageously maintained. It is easy to handle without compromising its biological properties. In addition, since the support holds the membrane tissue from both sides, a plurality of membrane tissues can be accommodated in one container, and the number of steps and cost can be advantageously reduced. is there.

[Brief description of the drawings]

FIG. 1 is an explanatory longitudinal sectional view showing a specific example of a storage / transport container for a membrane tissue according to the present invention.

FIGS. 2A and 2B are explanatory diagrams of a manufacturing process of the storage / transport container according to the present invention shown in FIG. 1, wherein FIG. 2A is an explanatory side view showing a form of a support before inserting a membrane tissue sheet, and FIG. FIG. 4 is an explanatory side view showing a form of a support after a membrane tissue sheet is inserted, and FIG. 4C is an exploded longitudinal sectional view showing a relationship among members when the support is housed in a housing.

FIGS. 3A and 3B are explanatory views showing another specific example of the support used for the storage / transport container according to the present invention, wherein FIG. 3A is a perspective view of the support in an open (open) state, and FIG. FIG. 3 is a side view of the support in a closed polymerization state.

FIG. 4 is an explanatory view showing still another specific example of the support used in the storage / transport container according to the present invention, wherein (a) is a perspective view of the support in an open state, and (b) is an open state. FIG. 3 is a side view of the support in FIG.

FIGS. 5A and 5B are explanatory views showing another specific example of the support used in the storage / transport container according to the present invention, wherein FIG. 5A is a plan view of the support in an open state, and FIG. FIG. 7C is a cross-sectional view showing the movement of the support that shifts to the closed polymerization state. FIG. 7C is a cross-sectional view of the support in the closed polymerization state.

FIG. 6 is an explanatory view showing another specific example of the support used in the storage / transport container according to the present invention, wherein (a) is a side view of the support in an open state, and (b) is a closed polymerization state. (C) is a plan view of the support in a closed polymerization state.

FIG. 7 is an explanatory view showing another specific example of the container main body used for the storage / transportation container according to the present invention. FIG. 7 (a) is a diagram in which a lid member and a box-shaped container are sandwiched and sealed by a clamping metal fitting. (B) is a longitudinal sectional view showing an example in which a lid member and a box-shaped container are hermetically sealed by screwing, and (c) is a longitudinal sectional explanatory diagram showing an example in which a lid member and a box-shaped container are sealed. It is a longitudinal section explanatory view showing an example engaged and fixed via a fastener.

FIGS. 8A and 8B are explanatory views showing another specific example of the container body used for the storage / transport container according to the present invention, wherein FIG. 8A is a longitudinal sectional view and FIG.

FIG. 9 is a cross-sectional explanatory view showing still another specific example of the container body used in the storage / transport container according to the present invention, wherein the lid member and the box-shaped container are provided with corresponding projections, and are accommodated. 2 shows a state in which a supporting member is held.

FIG. 10 is an explanatory longitudinal sectional view showing a form in which a liquid passage hole is provided in the support shown in FIG. 1 or FIG. 2;

11 is another explanatory view of the support shown in FIG. 3, wherein (a) is a longitudinal sectional view of the support in a closed polymerization state, and (b) is a partially enlarged view of FIG. 11 (a). FIG.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 10 Container 12 Membrane structure 14 Storage / transport liquid 24 Lid member 26 Container main body 28 Backing base material 32 Support member 34 Support

──────────────────────────────────────────────────続 き Continued on the front page (51) Int.Cl. ⁷ Identification symbol FI Theme coat ゛ (Reference) C12R 1:91) (72) Inventor Tetsu Kanan 5-1-1 Takamoridai, Kasugai-shi, Aichi 10 Menicon Corporation Within the Research Institute (72) Inventor Noritaka Yamamoto 5-1-1 Takamoridai, Kasugai-shi, Aichi F-term within Menicon Research Institute, Inc. (Reference) 4B029 AA21 BB11 CC08 4B065 AA90X AA93X BD12 CA44

Claims (13)

[Claims] 1. A liquid-permeable membrane configured to sandwich a flat membrane-like membrane made of a biological material from both sides and maintain its biological shape without deteriorating its biological properties. A support and one or more of the supports are accommodated together with a predetermined storage / transportation liquid, and the storage / transportation liquid can maintain the membrane structure held by the support in a wet state. Storage for membrane tissue, characterized in that it comprises an openable liquid and / or gas tight container body.
Transport container. 2. The method according to claim 1, wherein the support is a sponge, a non-woven fabric,
It is constituted by at least one of a support member having a woven fabric shape, a mesh shape, a film shape or a sheet shape, or a plate shape, and the at least one support member allows the membrane structure to be gripped from both sides. A storage / transport container for membrane tissue according to claim 1, characterized in that: 3. The support member comprises two of the support members, and a corresponding side of the two support members is formed by a group consisting of an adhesive, a fastener, a hook-and-loop fastener, a thread, a needle, and a hinge. 3. The storage / transport container for a membrane tissue according to claim 2, wherein the membrane tissue can be gripped between the two support members by being connected by a selected connection means. 4. The support member comprises three of the support members, and the three support members are connected by a connection selected from the group consisting of an adhesive, a fastener, a hook and loop fastener, a thread, a needle, and a hinge. 3. The membrane tissue according to claim 2, wherein the membrane tissue is connected by means to form a tri-fold structure, and the membrane tissue can be grasped between the three support members having the tri-fold structure. Storage / transport container for 5. The support body is formed of a thick plate-shaped sponge body, and a cut is made in a direction parallel to the plate surface with respect to a thick part of the sponge body, so that the inside of the cut is formed. 3. The storage / transport container for a membrane tissue according to claim 2, wherein the membrane tissue is inserted into and can be clamped. 6. The storage / transport container for a membrane tissue according to claim 1, wherein at least one surface of said support in contact with said membrane tissue is made water-repellent. 7. The support according to claim 1, wherein the support has a protrusion for physically fixing the membrane tissue on a surface facing the membrane tissue. A storage / transport container for the described membrane tissue. 8. The container body according to claim 1, wherein the support body and the storage /
The container according to any one of claims 1 to 7, further comprising: a box-shaped container that stores the transport liquid; and a lid member that closes an opening of the box-shaped container in a liquid-tight and / or air-tight manner. Storage / transport container for membrane tissue. 9. The storage / transport container for a membrane tissue according to claim 1, wherein the membrane tissue is supported by being backed by a predetermined base material. 10. The storage / transport container for a membrane tissue according to claim 1, wherein the storage / transport solution is a liquid medium, a physiological saline, or an isotonic solution. 11. The storage / transport container for a membrane tissue according to claim 1, wherein the membrane tissue is a cultured skin. 12. The storage / transport container for a membrane tissue according to claim 1, wherein the membrane tissue is a cultured epidermal cell sheet or a cultured epithelial cell sheet. 13. The storage / transport container for a membrane tissue according to any one of claims 1 to 12, wherein said membrane tissue is sandwiched between said supports to maintain its original shape. A method for preserving / transporting a membrane tissue, which comprises preserving or transporting while retaining biological activity.