JPWO2018163400A1 - Amniotic membrane piece and method for producing the same - Google Patents

Abstract

An amniotic membrane 11-1 having at least one amniotic membrane or one of its constituent layers, and a main body 13 having sides 13a to 13d for dividing a contour shape in a plan view, and means for distinguishing the front and back of the main body 13 , Which is a convex portion 15 protruding outward from the side 13b. It is preferable that the convex portion 15 has a triangular, quadrangular or arc shape. Further, the main body 13 is a line-symmetrical figure having at least one axis of symmetry Xa to Xd in the contour shape, and the projections 15 are divided with respect to all of the axis of symmetry Xa to Xd across the axis of symmetry. Preferably, the two regions are provided in a part of the main body 13 so as to be non-linearly symmetric.

Description

  The present invention relates to an amnion piece and a method for producing the same, and more particularly, to an amniotic piece capable of distinguishing front and back and a method for producing the same.

  The amniotic membrane is one of the embryo membranes enclosing the fetus and amniotic fluid, and is composed of an amniotic epithelial tissue, a basement membrane thereunder, and a collagen-rich parenchymal (stromal) tissue, and three layers having different characteristics. Since amniotic membrane is interposed between the mother and the fetus, which is a foreign substance to the fetus, it has low immunorejection and has anti-inflammatory and wound healing effects, so it has been used for covering wounds and wounds for a long time. Have been. In recent years, in the field of regenerative therapy, it has also been used for regenerating the cornea, skin, eardrum, and the like (for example, see Non-Patent Document 1).

  However, while a burn or a wound is a sudden event, an amniotic membrane can be obtained only at the time of parturition. Therefore, a means for long-term storage has been required to enable a stable supply of the amniotic membrane. As a solution to this need, a technique for drying an amniotic membrane while maintaining a regenerative function has been developed and is expected to be used in the field of regenerative therapy in the future (for example, see Patent Document 1).

  Further, as a means for suppressing the immunogenicity of the amniotic membrane, a dried amniotic membrane consisting of a basement membrane and a stromal tissue, or a laminated dry amniotic membrane consisting of a laminated membrane thereof, is used by peeling off the upper membrane of the amniotic membrane ( For example, see Patent Document 2). In order to enable long-term storage of the amniotic membrane, it is desirable that the amniotic membrane be dried until the residual water content in the amniotic membrane becomes 10% or less.

  In these drying methods, it is common to dry amniotic membrane pieces containing two or three layers among the layers constituting the amniotic membrane. Therefore, in such a dried amniotic membrane, the characteristics of the upper layer (front surface) and the lower layer (back surface) are different. Therefore, in use in medical treatment, the identification of the front and back of the amniotic membrane (hereinafter referred to as the front and back surfaces) in order to correspond to the application. This is called identification.). Furthermore, since the properties of amniotic membrane vary depending on individuals and depending on the processing, film thickness, and the like in the process of obtaining the amniotic membrane, it is necessary to identify and manage the source and the history of the acquisition. Also, in medical practice, a part of the amniotic membrane is peeled off to form two layers or vice versa, depending on the application, such as burns, wounds, and corneal regeneration. Will be.

  In the amniotic membrane drying step, generally, a plurality of amniotic membranes obtained from a plurality of sources are simultaneously cut into a sheet and dried. Specifically, after cutting out the amnion into a sheet shaped to fit a holder with a side length of several tens of centimeters in the drying device, mounting it on the holder and drying it continuously, it meets various demands for shipping. A lot is made by cutting to the combined size. For this reason, in order to avoid confusion among the sources, it is required that the lots can be identified not only at the stage of shipment but also during the production.

  In order to identify these two types, the front and back surfaces and the lot, it is preferable that they can be achieved by the same technology from the viewpoint of production efficiency. Dry amniotic membrane pieces are usually supplied in the form of a rectangle. This is because although the shapes of wounds and burns vary widely, it is efficient to arrange a plurality of rectangular amniotic membranes in order to cover them without gaps. Therefore, it is preferable that the supply is performed while maintaining at least a substantially rectangular shape without greatly destroying the rectangular shape. Here, the “substantially rectangular shape” means a shape having two pairs of two sides opposed to each other, and the angle formed between them is substantially 90 degrees.

On the other hand, in the treatment of the ocular surface such as corneal regeneration, a circular amniotic piece is usually used.
In this case as well, the recognition of the front and back surfaces and the lot recognition are required as in the above-described applications such as wounds, and it is desirable that the supply be performed while maintaining a substantially circular shape without largely destroying the circular shape. Here, the substantially circular shape means a shape having a substantially circular peripheral portion and a concave portion, a convex portion, or a minute hole formed in the peripheral portion of the circle.

  Several methods are known for identifying the front and back of an amniotic membrane piece. Specifically, an asymmetric label is attached to one surface of an amniotic membrane piece (for example, see Patent Document 3), an asymmetric pattern is formed (for example, see Patent Document 4), and irregularities are formed on one surface (for example, see Patent Document 4). For example, see Patent Document 5).

Japanese Patent No. 502119 U.S. Pat. No. 8,372,437 U.S. Pat. No. 8,597,687 U.S. Pat. No. 8,460,716 U.S. Pat. No. 8,460,715

Toshio Nikaido et al., "Amnion and Regenerative Medicine", Nissan Women's Magazine, Vol. 59, No. 9, N-536, September 2007

  Affixing a label to an amnion piece as in Patent Document 3 makes it possible to identify the front and back sides and the lot identification using characters and the like. However, attaching a label, which is a foreign substance, to an amniotic membrane may cause contamination, and the flexibility of the portion is different from the flexibility of a normal amniotic membrane, so that the degree of adhesion to an affected area may be unfavorable. . In addition to the equipment used for cutting the amniotic membrane, a label printing device is required, and an automatic transport device must be provided so that the cutting and printing can be linked. There is a problem in production, such as bulkiness.

  Further, the asymmetric patterning as in Patent Document 4 has problems such as low visibility and difficulty in identifying various patterns because the amniotic membrane is translucent.

  Further, in a method of forming irregularities on one surface of an amniotic membrane as in Patent Document 5, a method of providing an irregularity pattern on an amniotic membrane holding device used in a drying process and transferring the pattern to the amniotic membrane is adopted. However, it is necessary to form such a pattern on the holding table, which increases the manufacturing cost. In addition, since the amniotic membrane is translucent, it is difficult to visually recognize which side the uneven pattern is on, and after all There are problems such as having to confirm.

  SUMMARY OF THE INVENTION An object of the present invention is to provide an amniotic membrane piece which has high visibility, easily distinguishes the front and back surfaces, has little adverse effect on the characteristics of the amniotic membrane, and can be manufactured at low cost, and a method for manufacturing the same.

  The present invention relates to an amniotic membrane piece having at least one of an amniotic membrane or one of its constituent layers, and a main body having an end portion for dividing a contour shape in a plan view, and a means capable of distinguishing front and back of the main body. Wherein the identification portion is at least one of a convex portion protruding outward from the end portion, a concave portion recessed inward from the end portion, or a hole formed inside the end portion. A piece of amniotic membrane characterized in that:

  As described above, since the identification portion that can identify the front and back of the main body is any one of the convex portion, the concave portion, and the hole portion, the identification portion is clear. Further, in the present invention, since the identification portion has the shape as described above, there is less adverse effect on the characteristics of the amniotic membrane as compared with the case where a label or the like is attached to the amniotic membrane. Further, in the present invention, the identification portion can be easily formed by processing these shapes on the main body.

  Further, it is preferable that the convex portion and the concave portion have a triangular, quadrangular or arc shape. Alternatively, the hole is preferably triangular, square or circular.

  Since such a shape is easy to process, it is possible to manufacture an amniotic membrane piece that can be distinguished from the front and back at low cost. In addition, since these figures have better visibility than complicated figures, it is easy to identify the front and back sides.

  Further, the main body portion is a line-symmetrical figure having at least one line symmetry axis in the contour shape, and the identification portion is divided with respect to the at least one line symmetry axis across the line symmetry axis. Preferably, the two regions are provided on a part of the main body so as to be non-linearly symmetric.

  As described above, when the main body is a line-symmetrical figure, the identification unit is provided so that the two regions divided across the line-symmetrical axis are non-linearly symmetric with respect to all of the line-symmetrical axes. Can easily identify the front and back of the amniotic membrane piece.

  Further, in the above case, it is preferable that the main body is polygonal or circular.

  Since such a shape is easy to process, it is possible to manufacture an amniotic membrane piece that can be distinguished from the front and back at low cost.

  Still further, in the above case, the main body portion has a rectangular shape, and the axis of symmetry is two center lines passing through centers of two opposing two sides of the rectangular shape, It is preferable that the identification unit is provided in at least one of four regions divided by the two center lines.

  As described above, since at least one identification portion of the four regions is provided, the symmetry of the rectangular shape is broken by the identification portion, and the identification of the front and back sides is facilitated.

  Further, in the above case, the identification portion is a protrusion and a recess provided on one side of the four regions, and the protrusion and the recess are symmetrical with respect to a center of the one side. It is preferable to provide the

  As described above, since the identification portion is provided on the side, the identification portion is clear as compared with the case where the identification portion is provided at the corner, and the front and back sides can be more reliably identified.

  Further, it is preferable that the main body has a circular shape, and the plurality of identification portions are provided on a circumference of the main body.

  As described above, when the main body is circular, the front and back sides can be identified by providing a plurality of identification units.

  It is preferable that the main body is a non-linear symmetric figure having no axis of symmetry in the contour shape, and the identification section is provided at an arbitrary position of the main body.

  As described above, when the main body is a non-linear symmetric figure, the front and back can be identified only by the shape of the main body, but by further providing the identification portion, both the shape of the main body and the position of the identification portion can be determined. Thus, the front and back sides can be more reliably identified.

  A dried amniotic membrane piece having a water content of 10% by mass or less is preferred.

  In this way, it is possible to easily identify the front and back of a dried amniotic membrane piece.

  Further, the present invention is the method for producing an amniotic piece according to any one of the above, wherein the identification section is shaped by a cutting means.

  As described above, since the identification portion can be formed by the cutting process, the identification portion can be easily formed.

  In this case, when cutting a boundary line between two adjacent amniotic pieces, one of the two amniotic pieces is cut so as to be convex, so that a convex portion is formed on one of the two adjacent amniotic pieces. On the other hand, it is preferable to form a concave portion having a shape corresponding to the convex portion.

  By doing so, it is possible to manufacture two pieces of amniotic membrane by a single shape processing, and the manufacturing process can be further simplified.

  In this case, a pair of substantially rectangular amniotic pieces in an upright arrangement and an inverted arrangement are paired, and cutting is performed so that the sides on which the convex portions and the concave portions are formed are opposed to each other and close to each other. Is preferred. Further, in this case, it is preferable that the amniotic membrane pieces in the upright arrangement and the inverted arrangement are paired and shaped so that one convex portion and the other concave portion overlap each other.

  By performing the cutting process in this manner, the generation of useless portions can be reduced to half when producing amniotic membrane pieces.

  Preferably, the cutting means is a laser beam cutter. In this case, it is preferable that the identification section is the hole, and the main body is irradiated with a laser beam having substantially the same diameter as the hole or a diameter smaller than the diameter of the hole.

  As described above, since processing can be performed by the laser beam cutter, processing of a fine shape is also possible.

  In this case, it is preferable that the identification section is the hole, and the main body is irradiated with a laser beam having substantially the same diameter as the hole or a diameter smaller than the diameter of the hole.

  In this manner, by forming the hole with the laser beam, precise processing can be performed.

  Further, the present invention is the method for producing an amniotic piece according to any one of the above, comprising a cutting step of cutting a plurality of types of amniotic pieces of different lots from the amniotic membrane, wherein in the cutting step, the size of the identification unit is reduced. At least one of the shape and the position is changed for each lot.

  As described above, the lot can be identified by changing at least one of the size, shape, and position of the identification unit according to the lot.

  ADVANTAGE OF THE INVENTION According to this invention, it becomes possible to provide the amniotic membrane piece which has high visibility, can easily identify the front and back, and can be manufactured at low cost, and a method for manufacturing the same.

It is a top view showing the amniotic piece according to the first embodiment of the present invention. It is a top view showing the modification of the amnion piece concerning a 1st embodiment of the present invention. It is a flowchart which shows the manufacturing process of the amnion piece of this invention. It is a top view which shows the amnion piece which concerns on 2nd Embodiment of this invention. It is a top view showing the amniotic piece according to the third embodiment of the present invention. It is a top view showing the amniotic piece according to the fourth embodiment of the present invention. It is a top view showing the amniotic piece according to the fifth embodiment of the present invention. It is a top view showing the amniotic membrane piece concerning a 6th embodiment of the present invention.

  Hereinafter, a plurality of embodiments of the present invention will be described with reference to the drawings. The present invention is not limited by the members, arrangements, and the like described below, and these members and the like can be appropriately modified in accordance with the gist of the present invention. In the embodiment described below, a dried amniotic membrane piece obtained by drying an amniotic membrane and a method for producing the same are described. However, the amniotic membrane piece of the present invention is not limited to a dried amniotic membrane piece, and is a normal amniotic membrane piece that has not been dried. Also, a wet amniotic membrane piece immersed in a preservation solution or the like is included.

1. First embodiment (projection)
Hereinafter, the amniotic piece according to the first embodiment of the present invention will be described with reference to FIGS. 1 and 2. FIG. 1 is a plan view of an amniotic piece showing an embodiment in which the identification portion is a convex portion. FIG. 1A shows a triangular convex portion for identification, FIG. 1B shows an arc shape, and FIG. Is a rectangle, and FIG. 2D is an embodiment having a plurality of identification units. In the present embodiment, a convex portion is provided in a part of a rectangular amniotic piece that is a line symmetrical figure, and the amniotic piece is shaped into a substantially rectangular shape, thereby making the amniotic piece non-linearly symmetrical. Make sure they can be identified.

  As shown in FIG. 1A, the amniotic piece 11-1 includes a main body 13 and a convex part (identification part) 15. The main body 13 is a main part of the amniotic membrane piece 11-1, and the projections 15 are means used for identifying the front and back of the main body 13. The main body 13 has an end portion for dividing the contour shape in a plan view, and in the present embodiment, the contour shape is rectangular (square). The size of the main body 13 is not particularly limited, and may be various sizes depending on the application. However, when used for regenerative treatment, for example, a relatively large size of 1 × 1 cm, 2 × 2 cm, etc. In addition to a small square, a large square such as 5 × 5 cm and a rectangle such as 2 × 3 cm can be exemplified.

  The main body 13 has a rectangular shape, and an end is formed by four sides 13a to 13d. Further, the main body 13 has four axis of symmetry Xa to Xd, and is symmetrical in a plan view by these axis of symmetry Xa to Xd. That is, it can be said that the main body 13 has a contour shape (a shape divided by the sides 13 to 13d) as a line-symmetric figure. The line symmetry axis Xa is a center line passing through the midpoint of each of the two opposite sides 13a and 13b of the main body 13, and the line symmetry axis Xb is each of the two opposite sides 13c and 13d. It is the center line passing through the midpoint. The line symmetry axis Xc is a diagonal passing through the angle formed by the sides 13a and 13d and the angle formed by the sides 13b and 13c. The line symmetry axis Xd is formed by the angle formed by the sides 13a and 13c and the side 13b And a diagonal line passing through an angle formed by the side 13d.

The convex portion 15 is a means that enables identification of the front and back sides, and corresponds to the identification portion of the present invention. The protrusion 15 of the present embodiment is an isosceles triangle, and is provided on a part of the side 13b. The size of the isosceles triangle is not particularly limited. For example, when the main body 13 is 1 × 1 cm, the distance (height) from the side 13 b to the apex of the projection 15 with the bottom as the base is in the range of 1 to 3 mm. The inside is preferred, and the degree of about 2 mm is more preferred. When the size of the convex portion 15 is small, visibility is deteriorated, and it is easy to distinguish between the front and back sides.

  On the other hand, when the size of the convex portion 15 is large, a useless portion increases when a plurality of amniotic membrane pieces 11-1 are manufactured. That is, when cutting out a plurality of amniotic pieces from one amniotic membrane, the amniotic piece 11-1 of the rectangular main body portion 13 as in the present embodiment can be obtained by cutting the amniotic membrane into a checkerboard shape. The amniotic membrane piece can be cut out without waste (with good yield). However, since the amniotic piece 11-1 of the present embodiment includes the convex portion 15 protruding from the side 13b, the convex portion 15 of one amniotic piece and the convex portion 15 between the adjacent amniotic piece side are provided. The other parts are wasted without being included in the main body 13. Therefore, if the size of the convex portion 15 is too large, wasteful portions increase, and the yield in the manufacturing process is likely to deteriorate.

  The convex portion 15 is provided on the main body portion 13 so that two regions divided by the line symmetry axes Xa to Xd are non-linearly symmetric with respect to all the line symmetry axes Xa to Xd. In the present embodiment, the protrusions 15 are provided on one side 13b of the eight regions divided by the line symmetry axes Xa to Xd, but not on the line symmetry axes Xa to Xd.

  As described above, in the present invention, since the main body 13 has the convex portion 15 as the identification portion, it is possible to distinguish between front and back. In particular, when the main body 13 is a line-symmetric figure (rectangular shape) having the line symmetry axes Xa to Xd as in the present embodiment, the contour of the main body 13 is congruent on the front surface and the rear surface. Although it is impossible to distinguish between the front and back sides only by the outline shape, the presence of the recognition portion as in the present invention breaks the symmetry of the rectangle, so that the front and back sides can be distinguished. In addition, "disruption of symmetry" means that at least one of the areas divided by the axis of line symmetry does not become mathematically congruent with other areas (so as not to satisfy the mathematical congruence condition). In other words, providing a part. Here, "mathematical congruence" is defined as a shape in which the number of each side, the angle formed by each side, and the order of each side are equal.

  In addition, since the amniotic membrane is isotropic and relatively soft even when it is a dried product, it can be easily processed into any shape, and therefore, the identification portion can be easily processed. Therefore, it is possible to easily produce amniotic membrane pieces that can be distinguished from each other by a method such as cutting as described later.

  The convex portion 15 can be provided at any position as long as it is on the end portion (sides 13a to 13d) of the main body portion 13. However, the convex portion 15 is not on the line symmetry axes Xa to Xd as in the present embodiment. Is preferred. When the convex portions 15 are arranged on the axis of line symmetry Xa to Xd, the positions of the convex portions 15 are approximated between the front surface and the rear surface, and it is easy to distinguish front and back.

  To identify the front and back of the amniotic piece 11-1, the user stores the position of the convex portion 15 in advance. For example, when a doctor or the like performs regenerative treatment using an amniotic piece, for example, as shown in FIG. 1A, a convex portion 15 is formed above the center of a right side 13 b of a rectangular main body 13. If the user memorizes it as the front surface if it is located, it can be determined that the front surface is located when the convex portion 15 is located on the upper right side of the right side of the amniotic membrane 11-1 and that the rear surface is located if it is not located. . In this manner, it is possible to prevent the amniotic piece from being turned upside down. Alternatively, when the convex portion 15 is located on the upper side of the left side, the convex portion 15 may be determined to be the back surface.

  In addition, since the convex portion 15 of the present embodiment is a portion that protrudes outward from the side 13b, the portion can be held with tweezers or the like, and treatment or the like can be performed without contacting the main body 13. .

The position of the projection 15 may be shifted to an arbitrary position within the side 13b as long as the symmetry of the region divided by the line symmetry axes Xa to Xd is broken. In addition, the size of the protrusion 15 can be arbitrarily changed.

  Further, by changing at least one of the position and the size of the protrusion 15 in the plurality of amniotic pieces, the lot of the amniotic pieces can be identified. The term "lot" as used herein means the smallest unit in the process of manufacturing amniotic membrane pieces. The amniotic membrane pieces of the same lot are manufactured from amniotic membranes of the same origin and have the same main body. To make the lot identifiable at the position of the convex portion 15, for example, when the convex portion 15 is provided above the center of the side 13b, the lot A is the first lot, and when the convex portion 15 is provided above the center of the side 13b. If it does, it can be identified as B lot (second lot). Similarly, to make the lot identifiable by the size of the protrusion 15, for example, when the height of the protrusion 15 is 2 mm, the C lot (third lot) is used, and when the height of the protrusion 15 is 1 mm, Can be identifiable like the C lot (fourth lot).

  As described above, by changing at least one of the position and the size of the convex portion 15, it is possible to identify an infinite combination of lots. The longer the side on which the convex portion 15 is located, the higher the visibility of the lot difference, and the more lots can be identified.

  Further, a plurality of convex portions 15 may be provided on two sides. For example, it may be provided on the side 13a in addition to the side 13b. This makes it possible to distinguish more lots. Further, in a medical field, for example, for a small wound or burn, this amniotic membrane piece may be further cut into small pieces, but by providing the convex portions 15 at a plurality of positions as described above, each small piece is cut. , It is possible to identify the front and back surfaces and the lot.

  Next, FIGS. 1B and 1C show an amniotic membrane piece according to a modification of the present embodiment. In the amniotic membrane piece 11-2 (FIG. 1B), an arc-shaped convex portion 16 is used as an identification portion. In the amniotic membrane piece 11-3 (FIG. 1C), a rectangular convex portion 17 is used as an identification portion. It is provided in the unit 13. The size of each of the amniotic piece 11-2 and the amniotic piece 11-3 can be, for example, 1 × 1 cm, as in FIG. 1 (a), and each of the projections 16, 17 has a height of 2 mm. It can be. In addition, the size of the amniotic piece 11-2 and the amniotic piece 11-3 is not limited to 1 × 1 cm, but may be other sizes. As described above, according to the present invention, even when the identification portion has such an arc shape or the like, it is possible to identify the front and back surfaces of the amniotic membrane piece in the same manner as the triangular projection 15 shown in FIG. Become.

  FIG. 2D shows an amniotic membrane piece according to another modification of the amniotic membrane piece of the present invention. The amniotic piece 11-4 of this modified example has a triangular projection 15 and a rectangular projection 17 on the side 13b as identification portions. As described above, by providing a mixture of rectangles, triangles, and arc-shaped protrusions described in other modified examples as identification portions, it is easier to identify the front and back sides. In addition, by changing at least one of the position, shape, and size of the projection, lot identification of amniotic membrane pieces can be made possible.

  Further, by providing a plurality of identification portions with a plurality of amniotic pieces, it is also possible to greatly increase the number of lots that can be distinguished by combinations of positions and shapes. Note that the shape of the convex portion of the identification portion is not limited to these shapes, and a complex polygon can be used. However, it should be noted that if the polygon is excessively complex, the discriminability may decrease.

  When the identification portion is the convex portion 15 as in the present embodiment, when the amniotic pieces in the upright arrangement are arranged and cut out, the interval between the amniotic pieces is set to the width corresponding to the height of the triangular convex portion 15 (for example, 2 mm). Must be separated from each other, so that the amniotic membrane of that width is wasted. When the main body is 1 × 1 cm in size, the discarded portion is equivalent to 20% of the area of the amniotic membrane piece, and a considerable portion is wasted.

  As a method of reducing the amount of waste, as shown in FIG. 2 (e), the amniotic piece 11-1 in the upright position is rotated by 180 degrees, and the amniotic piece 11-1 ′ in the inverted position is adjacent to the amniotic piece 11-1. -1 and the projection 15 'of the amniotic membrane 11-1' are processed so as to be located on the same side surface. This makes it possible to share the peripheral portions of the protrusions 15 and 16 ′ with the adjacent amniotic piece 11-1 and the amniotic piece 11-1 ′, so that the discarded portion can be reduced by half. Further, when the shape of the amniotic membrane piece 11-1 is rectangular, by providing the protruding portion 15 on the short side, the discarded portion can be further reduced.

  Next, a method for producing an amniotic membrane piece of the present invention will be described. FIG. 3 is a flowchart showing a process for manufacturing amniotic membrane pieces from the acquisition of an amniotic membrane to drying and shipment. Amniotic membrane obtained by spontaneous delivery or cesarean section is provided via hospital. The acquisition status, blood type of mother and child, shape, thickness, degree of dirt, etc. are recorded and registered in a computer database or the like (amniotic membrane acquisition / registration step). After that, the amniotic membrane is inspected (inspection process), subjected to disinfection and cleaning (disinfection and cleaning process), and pre-cut to be placed on a drying stand, and a sheet (amniotic sheet) sized to allow the amniotic membrane to be placed on the drying device stand ) (Pre-cutting step). Next, the amniotic membrane sheet is put into a drying device and dehydrated and dried to obtain a dried amniotic membrane sheet (dehydration / drying step). After this step is completed, the dried amniotic membrane sheet is taken out from the drying device, cut into a desired size to form an amniotic membrane piece, and the lot is recorded in a database or the like (cutting / lot recording step). Finally, after packaging the amniotic membrane pieces and the desiccant, etc. (packaging process), they are shipped to a hospital or the like (shipping process).

  In the manufacturing method of the present embodiment, the dried amniotic membrane is cut to cut out amniotic membrane pieces having the identification portions. The processing of the shape of the amniotic membrane piece requires not a simple rectangular processing but a cutting processing of a complicated shape so as to form the convex portions 15 to 17 as identification portions. Therefore, in this embodiment, an automatic laser beam cutter is used. An automatic laser beam cutter is a device that cuts by irradiating a laser beam, and is a fully automatic device that automatically cuts a previously programmed shape. The amniotic membrane is a translucent film having a pale yellow color, and absorbs the fundamental wave (wavelength: 1.064 μm) of the YAG laser well, so that a small YAG laser device of 1 watt or less can be used. By programming this laser beam cutter to scan along the shape of the desired amniotic membrane, it becomes possible to continuously and efficiently form the main body portion and the convex portion of the amniotic membrane piece. In this way, by programming the movement of the laser beam in advance, it becomes possible to freely process even an identification unit having a complicated shape.

  In this embodiment, an automatic laser beam cutter is used. However, the method for cutting the amniotic membrane piece is not limited to the automatic laser beam cutter, and a cutting method using a normal cutter knife or scissors may be used. Further, in the present embodiment, the amniotic membrane piece is cut from the dried amniotic membrane. However, the invention is not limited thereto, and the amniotic membrane before drying may be cut.

  In addition, amniotic membranes obtained at hospitals and the like have an irregular shape of several tens of centimeters or more, and even in pre-cutting, they are finished in a constant shape to leave the peripheral part as much as possible without waste. Not. For this reason, it may be difficult to perform automatic cutting even after cutting after drying, and in that case, cutting may be performed semi-automatically, including installation by a human into a cutting machine.

Furthermore, since amniotic membranes of various sizes are cut out even from one dried amniotic sheet, and a plurality of amniotic sheets are often dried at the same time, it may be necessary to avoid confusion. For this identification, identification of a plurality of amniotic pieces manufactured in one drying step is required at a minimum, and it is preferable that identification can be performed on a lot-by-lot basis according to a source and a use. Must be able to identify Further, as described above, the amniotic membrane used for the treatment is formed by laminating a plurality of layers having different properties, and has different characteristics depending on the front and back surfaces.

  It is desirable that these requirements are satisfied by a method that is as simple as possible and has high discrimination without contamination of impurities. Therefore, as described above, by combining the position and the shape of the identification portion so as to exhibit diversity, it is possible to identify not only the front and back of the amniotic membrane but also the lot.

2. Second embodiment (recess)
Next, an amniotic membrane piece according to a second embodiment of the present invention will be described with reference to FIG. 4A and 4B are plan views showing an amniotic piece having a recessed identification portion. FIG. 4A is a triangular recessed portion, FIG. 4B is an arcuate recessed portion, and FIG. 4C is a rectangular recessed portion. FIG. 4D shows an embodiment in which corners are cut out. In the first embodiment, the front and back sides can be identified by breaking the line symmetry of the square by using the convex portion protruding outward from the end of the main body portion as the identification portion. By making the recess recessed into the inside from the end of the portion the identification portion, the line symmetry of the main body is broken and the front and back sides can be identified.

  As shown in FIG. 4A, the amniotic piece 21-1 of the present embodiment has a main body 13 having a rectangular shape and four axes of linear symmetry Xa to Xd. The concave portion 24 of the present embodiment is provided on one side 13b of the eight regions divided by the line symmetry axes Xa to Xd, but not on the line symmetry axes Xa to Xd. The recess 24 of the present embodiment can be a right-angled triangle having a height of 2 mm, but is not limited to this, and may be a height of 1 mm or the like. Here, the “height” means a distance from the side 13b to the bottom side to the apex angle of the concave portion 24. Further, the position of the concave portion 24 can be an arbitrary position within the side 13b as long as the position of the concave portion 24 becomes a non-linear symmetry by breaking the symmetry of the main body portion 13.

  It is possible to identify the front and back surfaces by the concave portion 24, and to enable lot identification by changing the position and size of the concave portion 24, which is an identification portion, when manufacturing a plurality of amniotic pieces. , And the same as in the first embodiment. Further, the size of the main body 13 is not limited to the above 1 × 1 cm, but may be a rectangle such as 2 × 3 cm or a large one of 5 × 5 cm. Further, as the length of the side 13b forming the concave portion 24 becomes longer, the visibility of the lot difference can be increased, and many lots can be distinguished.

  As described above, when the identification portion is a concave portion, compared with the case of the convex portion as in the above-described first embodiment, the processing can be performed only by cutting out the end portion of the main body portion. This is only the notch. Therefore, in the present embodiment, compared with the case of forming the above-mentioned convex portion, the discarded portion of the amniotic membrane is reduced, and the use area efficiency is good.

  Furthermore, a plurality of concave portions 24 may be provided on the side 13b, and in that case, the shape and position of the concave portions 24 may be variously changed. Thereby, when manufacturing a plurality of amniotic membrane pieces, it is possible to distinguish more lots. Similarly, even for a large-sized amniotic piece, the triangular recess 24 of the present embodiment makes it possible to identify the front and back surfaces.

  The amniotic membrane piece 21-1 of this embodiment can be manufactured by using an automatic laser beam cutter using a YAG laser, as in the first embodiment described above. By using the automatic laser beam cutter in this manner, the end portion and the concave portion of the main body can be continuously processed.

Next, FIGS. 4B to 4D show amniotic membrane pieces according to a modification of the present embodiment. In the amnion piece 21-2 (FIG. 4B), an arc-shaped concave portion 25 is used as an identification portion, and in the amniotic film 21-3 (FIG. 4C), a rectangular concave portion 26 is used as an identification portion. In preparation. Amniotic piece 21
-2 and the size of the amnion piece 21-3 can each be, for example, 1 × 1 cm, and the height of the depressions of each of the recesses 25, 26 can be 2 mm. This makes it possible to identify the front and back surfaces in the same manner as the triangular recess 24. The size of the amniotic piece 21-2 and the amniotic piece 21-3 is not limited to 1 × 1 cm, but may be another size. Further, it is the same as the above-described embodiment that the shape of these amniotic membrane pieces can be processed using an automatic laser beam cutter.

  By using a mixture of these concave portions having a triangular shape, an arc shape, and a rectangular shape, it is possible to more reliably identify the front and back sides. In the case of manufacturing a plurality of amniotic membrane pieces, it is also possible to enable lot identification of amniotic membrane pieces by changing at least one of the position, shape, and size of the concave portion. In this case, it is possible to significantly increase the number of lots that can be identified by using a mixture of concave portions having a triangular, arc, or rectangular shape. Further, the concave portions of the present embodiment and the convex portions of the first embodiment may be mixed. Thus, the number of lots that can be identified can be further increased.

  Further, as shown in FIG. 4D, a corner of the main body 13 may be cut out to form a concave portion 27, which may be used as an identification portion. In the present embodiment, the corner of the main body 13 is cut out in a triangular shape, and the shape is asymmetric left and right with respect to the diagonal line of the main body 13. Providing the cutout portion in this way also makes it possible to discriminate the front and back by breaking the symmetry of the main body portion 13 which is a line-symmetrical figure.

  The notch angle of the concave portion 27 with respect to the corner of the main body 13 can be any angle as long as the front and back can be identified. In the case of manufacturing a plurality of amniotic pieces, lot identification can be performed by changing the notch angle.

  In the case where the identification portion is formed by cutting out the corners of the main body portion 13 as in the present embodiment, the shape is changed according to the cutout angle to provide versatility. It is generally difficult to make such a versatile shape. For this reason, the identification of the front and back by the shape of the identification portion and the lot identification in the case of manufacturing a plurality of amniotic pieces are performed in a more complicated shape such as the identification portion provided on the side as in the above-described embodiment. It tends to be more difficult than the identification unit. In addition, since the corners of the main body 13 are parts that are likely to be bent or damaged, it may be difficult to distinguish them from these. On the other hand, since the notch at the corner of the main body 13 can be easily formed, it is superior from the viewpoint of manufacturing cost and the like as compared with the case where complicated shape processing is performed.

  An automatic laser beam cutter can be used as a method of manufacturing an amniotic membrane piece according to the present embodiment as in the first embodiment, but it is needless to say that the present invention is not limited to this. In this embodiment, since a target shape is formed by cutting out a part of the rectangular shape, there is no convex portion, and a plurality of erect amnion pieces can be arranged and cut so as to be adjacent to each other. . For this reason, since there is no useless portion in the area between the adjacent amniotic pieces like the convex portion of the first embodiment, the yield in the manufacturing process is relatively higher than that of the amniotic piece of the first embodiment. Good.

3. Third embodiment (combination of concave and convex portions)
Next, an amniotic membrane piece according to a third embodiment of the present invention will be described with reference to FIG. FIG. 5 is a plan view showing an amniotic piece having a convex portion and a concave portion as an identification portion, and FIG. 5A shows an embodiment in which both the convex portion and the concave portion are rectangular. As shown in FIG. 5A, the amniotic membrane piece 31-1 of the present embodiment has a main body 13 having a rectangular (square) shape, and has four line-symmetric axes Xa to Xd. It is provided on one side 13b of the eight regions divided by the line symmetry axes Xa to Xd, but not on the line symmetry axes Xa to Xd.

  In the present embodiment, a convex portion 17 and a concave portion 26 are provided as identification portions. The convex portion 17 of the present embodiment is provided on one side 13b of the eight regions divided by the line symmetry axes Xa to Xd but not on the line symmetry axes Xa to Xd. Are provided on one side 13b of the eight regions divided by the line symmetry axes Xa to Xd, but not on the line symmetry axes Xa to Xd. In addition, the convex portion 17 and the concave portion 26 are provided in different regions of eight regions defined by the axis of line symmetry Xa to Xd, respectively. The convex portion 17 and the concave portion 26 have a rectangular outline shape, and the outline shapes of both are congruent, so that no gap is formed when the convex portion 17 and the concave portion 26 are abutted. In addition, although the convex part 17 and the recessed part 26 of this embodiment can each be made into the rectangular shape of 2 mm in height, it is not limited to this, For example, it is good also as 1 mm in height.

  With this configuration, it is possible to reduce the waste portion of the amniotic membrane as much as possible and to simultaneously form the uneven portions of the two amniotic membrane pieces. That is, as shown in FIG. 5B, first, the outer periphery of an amniotic membrane piece having a size corresponding to two pieces of the amniotic membrane piece 31-1 and the amniotic membrane piece 31-1 'is cut. Further, at the center thereof, the convex portion 17 of the amniotic piece 31-1 and the concave portion 26 'of the amniotic piece 31-1', the concave portion 26 of the amniotic piece 31-1 and the convex portion 17 'of the amniotic piece 31-1' are provided. The shapes are processed so as to be at positions where they abut each other. Thereby, the amniotic membrane piece 31-1 having the uneven portion and the amniotic membrane piece 31-1 'rotated by 180 degrees can be simultaneously produced. Further, in this case, since the projections and depressions of each piece of amniotic membrane correspond to each other, no abandoned portion is generated and the amniotic membrane can be used efficiently.

  Further, when the affected part is extensive in the medical field, a plurality of amniotic pieces may be arranged and attached to the affected part. However, as in the present embodiment, the contours of the convex part 17 and the concave part 26 are congruent, When the concave portion and the convex portion of the amnion piece to be abutted are bonded to the affected part, no gap is generated between the amniotic pieces. This makes it difficult for air infection or the like to occur through the gap between the amniotic membrane pieces. Also, when a plurality of amniotic pieces are stuck to the affected part when the amniotic pieces are superimposed and stuck to the affected part, the part does not come into contact with the affected part, resulting in a useless area. If it can be bonded without gaps between the pieces of amnion to be used, it is possible to eliminate useless areas.

  The amniotic membrane piece of the present embodiment can also be manufactured by an automatic laser beam cutter programmed to follow an uneven portion, similarly to the first and second embodiments described above. Further, even if the positions of the convex portion 17 and the concave portion 26 are shifted to arbitrary positions within the side 13b, the state where the symmetry is broken can be maintained. This makes it possible to easily create a plurality of states for lot identification. Furthermore, in the present embodiment, the convex portion 17 and the concave portion 26 have a rectangular shape. However, the shape is not limited to this, and any shape such as an arc shape or a rectangular shape may be used as long as the shape maintains mathematical congruence with each other. Can also be used. Further, in the present embodiment, the positions of the convex portion 17 and the concave portion 26 are on the same side 13b, but they may be arranged on different sides.

  As described in detail above, according to the amniotic membrane piece of the present embodiment, it is possible to eliminate a portion to be discarded in the shape processing, and to provide an amniotic membrane with a high use efficiency and thus a cheap dry amniotic membrane piece. . Also, when manufacturing a plurality of amniotic membrane pieces, lot identification becomes possible by changing at least one of the shape, size, and position of the identification unit for each lot.

4. Fourth embodiment (hole)
Hereinafter, an amniotic membrane piece according to the fourth embodiment of the present invention will be described with reference to FIG. FIG. 6 is a plan view showing an amniotic piece having a hole in the identification portion. FIGS. 6 (a) and 6 (c) show a case where the main body is rectangular, and FIG. 6 (b) shows a case where the main body is square. It is a form. As shown in FIG. 6A, in the amniotic piece 41-1 of the present embodiment, the main body 43 is a rectangular line-symmetric figure, and has two line-symmetric axes Xa and Xb. The line symmetry axis Xa is a center line passing through a midpoint between two opposing sides 43a and 43b, and the line symmetry axis Xb is a center line passing through a midpoint between two opposing sides 43c and 43d.

  The identification portion of the present embodiment is a hole 46 formed inside the sides (ends) 43 a to 43 d of the main body 43. The hole 46 of the present embodiment has a circular shape and is provided at a peripheral portion of one of four regions divided by the axis of line symmetry Xa, Xb. The size of the main body 43 can be, for example, 1 × 2 cm, but is not limited thereto. The size of the hole 46 can be, for example, 0.5 mm in diameter, but is not limited to this, and can be 1 mm or 2 mm. The position of the hole 46 is provided at a position close to a corner formed by the side 12b and the side 13a. However, the position is not particularly limited, and may be a position close to the line symmetry axis Xa. The position of the center of the hole 46 is preferably within a range of about 1 to 5 mm from each of the sides 43b and 43d.

  Next, FIG. 6B shows another modification of the present embodiment. In the amniotic membrane piece 41-2, the shape of the main body 13 is substantially rectangular (square), and its size can be, for example, 1 × 1 cm. In this case, not only the center line of the main body portion 13 but also the diagonal lines Xc and Xd become the axes of symmetry, and therefore have a total of four axis of symmetry Xa to Xd. In addition, the hole 46 has a substantially circular shape, and it is difficult to distinguish between the front and back sides by its own shape. Therefore, the hole 46 is formed at a position avoiding the line of the line symmetry axes Xa to Xd. Thereby, it is possible to obtain an amnion piece having an asymmetric shape even when the main body is square. The hole 46 may be provided anywhere in the main body 13 unless the center is located on the line of the line symmetry axes Xa to Xd, and a plurality of holes may be provided. Therefore, when manufacturing a plurality of amniotic pieces, it is possible to produce a large number of amniotic pieces that can be identified in lots.

  FIG. 6C shows another modification of the present embodiment. In this modification, the main body 43 has a rectangular shape having sides 43a to 43d as in FIG. 6A, but three identification portions and three types of holes 46 to 48 (circular holes 46, 48) are provided. This is an example having a triangular hole 47 and a square hole 48). The number and shape of the holes 46 to 48 are arbitrary, and by arbitrarily changing the shapes of the holes 46 to 48, a large number of nonlinear shapes can be created. Identification becomes possible.

  The diameters and side lengths of these holes 46 to 48 are usually in the range of 0.1 to 2 mm, and can be sufficiently distinguished by about 0.5 mm, and the effect of the holes on the treatment is negligible. is there. The holes 46 to 48 can be formed by using an automatic laser beam cutter as in the above-described embodiment. In the case of the circular hole 46, it can be processed using a laser beam focused to the same size. That is, the hole 46 can be formed by irradiating the main body 43 with a laser beam having a diameter equal to the diameter thereof for a short time.

  In processing the triangular holes 47 and the square holes 48 including the circular holes 46, a laser beam focused to a smaller diameter than the size of the holes is used to further increase the light condensing degree. The holes 46 to 48 can be formed by scanning these beams along the periphery of the holes 46 to 48. Thereby, holes of various shapes can be machined with higher shape accuracy.

  According to this embodiment, it is easy to use for treatment because it is possible to distinguish between the front and back surfaces only by forming a small hole, and the production process is simple and the amniotic membrane piece can be manufactured at low cost. .

5. Fifth embodiment (circular)
Hereinafter, an amniotic membrane piece according to the fifth embodiment of the present invention will be described with reference to FIG. FIG.
FIG. 7A is a plan view illustrating a piece of amniotic membrane having a circular main body, FIG. 7A is an embodiment having two convex portions as an identification portion, FIG. 7B is an embodiment having a convex portion and a concave portion, and FIG. (C) is an embodiment having a total of three convex portions and concave portions, FIGS. 7 (d) and 7 (e) are embodiments having a hole as an identification portion, and FIG. 7 (f) is a convex portion and a concave portion. FIG. 7 (g) shows an embodiment in which a plurality of amniotic membrane pieces are cut out.

  As shown in FIG. 7, in the present embodiment, the main body 53 is a substantially circular line-symmetric figure. A circle is a line-symmetrical figure in which all lines passing through its center line are line-symmetrical axes. In the case of the circular main body 53, even if there is only one discriminating part, it is possible to discriminate the front and back depending on the shape. However, if there is only one discriminating part, it is necessary to determine the front and back by only the shape. The identification tends to be difficult. Therefore, in the amniotic piece 51-1 (FIG. 7 (a) and the amniotic piece 51-2 (FIG. 7 (b)) of the present embodiment, the asymmetrical shape of the substantially circular amniotic piece is obtained by processing the shape in two places as the identification portion. In other words, the amniotic piece 51-1 has two convex portions (identifying portions) 15 and 17 having different shapes, and the amniotic piece 51-2 has a triangular convex shape (identifying portion) 15 and a triangular shape. Are provided around the circumference (end) of the main body 53 so as to asymmetrical the shape of the amniotic membrane piece.

  In the present embodiment, each of the two identification portions is disposed at a position that is 90 degrees from each other when viewed from the center O of the substantially circular main body portion 53. Note that the arrangement of the identification unit is not limited to this, and the identification unit can be arranged at any position as long as the amniotic membrane can be identified from the front and back. It is preferable that the angle formed by the two discriminating portions is a position other than a position where they are 180 degrees from each other. If the angle formed by the two discriminating portions is 180 °, the discriminating portions are arranged on the axis of line symmetry, so that the shapes of the front and back sides are approximated, and it is easy to distinguish between the front and back sides. In addition, if the substantially circular amniotic pieces 51-1 and 51-2 can be asymmetrical and the front and back can be identified, the angle formed by the two identification portions may be any angle other than 180 degrees. it can. Further, by changing the difference between the angles formed by the two discriminating portions by an angle by which the front and back can be discriminated, a large number of asymmetric shapes can be formed. Thus, when a plurality of amniotic membrane pieces are manufactured, the identification unit can be used for lot identification.

  Amnion piece 51-3 (FIG. 7 (c)), amniotic piece 51-4 (FIG. 7 (d)), amniotic piece 51-5 (FIG. 5 (e)), and amniotic piece 51-6 (FIG. 7 (f) In the case of (3), the substantially circular amniotic piece is made asymmetric by providing three identification portions. Further, this identification unit can be used for lot identification when a plurality of amniotic membrane pieces are manufactured. The amniotic membrane piece 51-3 (FIG. 7 (c)) is obtained by providing the main body 53 with an arc-shaped convex part 16 in addition to the convex part 15 and the concave part 24 of the above-mentioned amniotic membrane piece 51-2 (FIG. 7 (b)). I have. Thereby, a large number of shapes can be formed by the main body 53, and the identification of the front and back sides becomes easier. Further, when a plurality of amniotic membrane pieces are manufactured, the number of lots that can be identified can be increased. The amniotic membrane piece 51-4 (FIG. 7D) has three circular holes 46, and the amniotic membrane 51-5 (FIG. 7E) has a circular hole 46, a triangular hole 47, and a square hole. By providing the three types of identification portions of the holes 48 in the main body 53 in the amniotic membrane piece 51-6 (FIG. 7 (f)), the convex portion 15, the concave portion 26, and the hole portion 46 are provided. The part 53 is made asymmetric so that the front and back can be distinguished. In the case of manufacturing a plurality of amniotic pieces, it is possible to improve the discriminability of lots by using three types of identification units. In forming the shapes of these identification portions, the shape can be suitably processed by an automatic laser beam cutter as in the other embodiments described above.

  Further, when a plurality of amniotic pieces are manufactured from the amniotic sheet, as shown in FIG. 7 (g), they are arranged such that the circumferential portion of the circular main body 53 is in a position where it comes into contact with the adjacent amniotic piece. It is preferable that the projections 15 and 17 be cut out so as to be located in the gap between the adjacent amniotic membrane pieces 51-1. By cutting out amniotic pieces from the amniotic sheet as described above, an extra portion after cutting out can be reduced, and the yield of the amniotic sheet can be improved.

In the embodiment described above, the identification portion is a part of a book that can be formed by using the above-described protrusions, recesses, and holes, and by mixing these, countless lots can be identified. Becomes

6. Sixth embodiment (non-linear symmetric figure)
Hereinafter, an amniotic membrane piece according to the sixth embodiment of the present invention will be described with reference to FIG. As shown in FIG. 8, in the present embodiment, the main body 63 has a trapezoidal shape that is not an isosceles trapezoid, and is a non-linearly symmetrical figure having no axis of symmetry in the contour shape. In the present embodiment, a hole 46 as an identification unit is provided at an arbitrary position of the main body 63. Since an asymmetrical figure does not have a line symmetry axis, it is possible to identify the front and back sides by itself, but the present embodiment further includes an identification unit. For this reason, in addition to the front and back identification by the main body 63 which is a non-linear symmetrical figure, the front and back identification by the position of the identification unit and the like are possible, and the identification of the front and back can be performed more reliably.

  The inclination angle of the corner 63a of the main body 63 is not particularly limited, but is usually in the range of 1 to 85 °. In addition, from the viewpoint of the distinction between the front and back by the main body 63 itself, the front and back can be sufficiently distinguished if the inclination angle of the corner 63a is 3 ° or more. On the other hand, if the inclination angle of the corner 53 is too acute, it becomes difficult to match the shape of the treatment portion, and the portion is easily peeled off. Therefore, from these points, the inclination angle of the angle 53 is preferably in the range of 3 to 10 °. In the treatment, it is preferable to pinch the acute angle portion 53 with tweezers to easily grasp the amniotic piece and to easily adhere to the affected part.

  Advantages of the present embodiment include ease of manufacturing amniotic membrane pieces. That is, as shown in FIG. 8B, as in the case of the third embodiment (FIG. 5), the two pieces of the amniotic membrane 61-1 of this embodiment and the amniotic membrane 61-1 ′ obtained by rotating the same by 180 degrees are used. Two pieces of amniotic membrane pieces can be produced simultaneously by cutting the boundary part obliquely so that the sides forming the asymmetry of both are sandwiched inside. As a result, the cutting can be performed without generating a useless portion of the amniotic membrane. Further, since the cut portion is straight, the cut portion can be cut by a cutter having a normal straight blade, but may be cut by an automatic laser cutter.

  As described above, the present invention has been described with reference to the plurality of embodiments, but the present invention is not limited to the above embodiments. The number of the identification portions can be three or more, and the convex portions, the concave portions, and the hole portions can be freely combined. In addition, the shape, position, and size of the identification unit can be arbitrarily changed. Further, the shape of the main body is not limited to the above-described rectangular shape, rectangular shape, circular shape, and trapezoidal shape, and various shapes can be adopted. For example, as other examples of the figure whose outline shape is a line symmetry, an isosceles triangle (one line symmetry axis), an equilateral triangle (three line symmetry axes), a rhombus (two line symmetry axes), and an ellipse ( And two semi-circles (one axis of line symmetry). Another example of a figure having a non-linearly symmetrical contour shape of the main body is a parallelogram.

  The amniotic membrane piece of the present invention is not limited to the amniotic membrane itself as long as it has at least one layer (membrane) constituting the amniotic membrane. For example, it may be composed of one or more of an amniotic epithelial tissue, a basement membrane, and a stromal tissue constituting the amniotic membrane, and may further include a tissue derived from a material other than the amniotic membrane.

Since the amniotic membrane piece of the present invention can easily identify the front and back surfaces, when used for treatment of a burn or a wound, the affixed surface is not mistaken and can be used accurately for each treatment. Further, when a plurality of amniotic membrane pieces of the present invention are manufactured, the lot can be identified by changing at least one of the position, shape, and size of the identification portion. Lot management is possible from middle to after shipment. This makes it possible to reliably trace the history of the amnion pieces used in the operation, etc., so that, for example, if there is a difference in the treatment effect, it becomes easier to elucidate the cause, and it is possible to appropriately respond to subsequent treatment At the same time, it is possible to provide data for developing more optimal amniotic membrane pieces.

11-1 to 11-4, 11-1 ', 21-1 to 21-3, 31-1, 31-1', 41-1 to 41-3, 51-1 to 51-6, 61-1, 61-1 'amniotic membrane fragment, 13, 43, 53, 63 main body, 13a to 13d, 43a to 43d side (end), 15, 15', 16, 17, 17 ', convex (identification), 24 , 26, 26 ', 27 recess (identification part), 46, 47, 48 hole (identification part), Xa-Xd line symmetry axis, O center

Claims (17)

An amniotic membrane or a piece of amniotic membrane having at least one of its constituent layers,
It is composed of a main body having an end portion that divides the contour shape in a plan view, and an identification portion that is a means that can identify the front and back of the main body,
The identification portion is at least one of a convex portion protruding outward from the end portion, a concave portion recessed inward from the end portion, and a hole formed inside the end portion. And amniotic piece.   The amniotic membrane piece according to claim 1, wherein the convex portion and the concave portion have a triangular shape, a quadrangular shape, or an arc shape.   The piece of amniotic membrane according to claim 1, wherein the hole is triangular, quadrangular or circular. The main body is a line-symmetrical figure having at least one axis of symmetry in the contour shape,
The identification unit is provided on a part of the main body such that two regions divided by the line of symmetry are non-linearly symmetric with respect to all of the at least one line of symmetry. The amniotic membrane piece according to claim 1, wherein   The amniotic membrane piece according to claim 4, wherein the main body is polygonal or circular. The main body has a rectangular shape,
The axisymmetric axes are two center lines passing through centers of two opposite sides of the rectangular shape,
The amniotic membrane piece according to claim 5, wherein the identification unit is provided in at least one of four regions divided by the two center lines. The identification unit is a protrusion and a recess provided on one side of the four regions,
The amniotic membrane piece according to claim 6, wherein the convex portion and the concave portion are provided at positions symmetrical with respect to the center of the one side. The main body is circular,
The amniotic membrane piece according to claim 5, wherein a plurality of the identification portions are provided on a circumference of the main body portion. The main body is a non-linear symmetric figure having no axis of symmetry in the contour shape,
The amniotic membrane piece according to claim 1, wherein the identification section is provided at an arbitrary position on the main body section.   The amniotic membrane piece according to any one of claims 1 to 9, wherein the amniotic membrane piece is a dried amniotic membrane piece having a water content of 10% by mass or less. A method for producing an amniotic membrane piece according to any one of claims 1 to 10,
The method for manufacturing an amniotic membrane piece, wherein the identification unit is shaped by a cutting unit. By cutting one amniotic membrane one side into a convex shape when cutting the boundary line between two adjacent amniotic membrane pieces,
The method of claim 11, wherein a convex portion is formed on one of the two adjacent amniotic pieces and a concave portion having a shape corresponding to the convex portion is formed on the other.   A pair of substantially rectangular amniotic membrane pieces in an upright arrangement and an inverted arrangement are paired, and cut so that one side on which the respective convex portions and concave portions are formed is opposed to and close to each other. A method for producing an amniotic membrane piece according to claim 12.   The method for producing an amniotic piece according to claim 12, wherein the amniotic membrane pieces in the upright arrangement and the inverted arrangement are paired and shaped so that one convex portion and the other concave portion overlap each other.   The method according to claim 11, wherein the cutting means is a laser beam cutter.   16. The amniotic membrane piece according to claim 15, wherein the identification portion is the hole, and the main body is irradiated with a laser beam having a diameter substantially the same as the hole or a diameter smaller than the diameter of the hole. Production method. A method for producing an amniotic membrane piece according to any one of claims 1 to 10,
With a cutting process to cut multiple types of amniotic membrane pieces of different lots from amniotic membrane,
In the cutting step, at least one of the size, shape, and position of the identification unit is changed for each lot.

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