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WO2018163400A1 - Pièce de membrane amniotique et sa méthode de fabrication - Google Patents

Pièce de membrane amniotique et sa méthode de fabrication Download PDF

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Publication number
WO2018163400A1
WO2018163400A1 PCT/JP2017/009682 JP2017009682W WO2018163400A1 WO 2018163400 A1 WO2018163400 A1 WO 2018163400A1 JP 2017009682 W JP2017009682 W JP 2017009682W WO 2018163400 A1 WO2018163400 A1 WO 2018163400A1
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WO
WIPO (PCT)
Prior art keywords
amniotic membrane
identification
main body
shape
amniotic
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2017/009682
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English (en)
Japanese (ja)
Inventor
上柳　喜一
田中　淳
信行 荒川
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Amnos Co Ltd
Original Assignee
Amnos Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Amnos Co Ltd filed Critical Amnos Co Ltd
Priority to PCT/JP2017/009682 priority Critical patent/WO2018163400A1/fr
Priority to JP2019504264A priority patent/JP6861444B2/ja
Publication of WO2018163400A1 publication Critical patent/WO2018163400A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices

Definitions

  • the present invention relates to an amniotic membrane piece and a method of manufacturing the same, and more particularly to an amniotic membrane piece whose front and back can be distinguished and a method of manufacturing the same.
  • Amniotic membrane is one of the embryonic membranes that enclose the fetus and amniotic fluid, and is composed of three layers with different properties, each of amniotic epithelial tissue and underlying basement membrane, and collagen-rich parenchymal (stromal) tissue.
  • Amnion which is a foreign substance for the fetus, is interposed between the mother and the fetus, so it has low immune rejection and has anti-inflammatory and wound healing properties and has long been used for the treatment of burns and wounds, etc. It has In recent years, in the field of regenerative treatment, it is also used for regeneration of cornea, skin, tympanic membrane and the like (see, for example, Non-Patent Document 1).
  • the upper membrane of amniotic membrane is peeled off, and dry amniotic membrane consisting of basement membrane and stromal tissue, and laminated dry amniotic membrane consisting of a membrane obtained by laminating them are used See, for example, Patent Document 2).
  • amniotic membranes from a plurality of suppliers are simultaneously cut out into sheets and dried. Specifically, after the amniotic membrane is cut out in a sheet shape having a size in which the length of one side of the drying device is matched to a holder of several tens of centimeters, mounted on the holder, and dried continuously, various demands are made for shipment. Cut to a combined size to form a lot. For this reason, in order to avoid confusion of the acquisition sources etc., it is required to be able to identify those lots not only at the shipping stage but also during production.
  • the rectangular shape means a shape having two pairs of opposing sides and maintaining an angle of about 90 degrees formed by each other.
  • 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.
  • 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.
  • An object of the present invention is to provide an amniotic membrane piece which can be easily manufactured at low cost and has a high visibility and easy discrimination between the front and back, and a small adverse effect on the characteristics of the amniotic membrane.
  • the present invention is an amniotic membrane piece comprising at least an amniotic membrane or one of its constituent layers, which is a main body having an end for dividing the outline shape in plan view and a means capable of identifying the front and back of the main body. And the identification portion is at least one of a convex portion protruding outward from the end, a concave portion recessed inward from the end, and a hole formed inside the end. It is an amniotic piece characterized by being one.
  • the identification part which can identify the front and back of a main-body part is either a convex part, a recessed part, and a hole part, an identification part is clear. Further, in the present invention, since the identification portion has the shape as described above, the adverse effect on the characteristics of the amniotic membrane is small compared to 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 in the main body portion.
  • the said convex part and the said recessed part are triangles, a square, or circular arc shape.
  • the hole is preferably triangular, square or circular.
  • the main body portion is a line symmetry figure having at least one line symmetry axis in the contour shape, and the identification part is divided across the line symmetry axis at all of the at least one line symmetry axis. It is preferable that the two regions be provided on a part of the main body so as to be non-linearly symmetrical.
  • the identification portion is provided such that the two regions divided across the line symmetry axis at all the line symmetry axes become non-line symmetry.
  • the position of the amniotic membrane makes it possible to easily identify the front and back of the amniotic membrane.
  • the main body portion is preferably polygonal or circular.
  • the main body portion is a rectangular shape
  • the line symmetry axis is two center lines passing through centers of two opposing sides of the two rectangular shapes
  • the identification unit be provided in at least one of the four regions divided by the two center lines.
  • the symmetry of the rectangular shape is broken by the identification portion, so that the identification of the front and back becomes easy.
  • the identification portion is a convex portion and a concave portion provided on one side of the four regions, and the convex portion and the concave portion are symmetrical with respect to the center of the one side. It is preferable to be provided in
  • the identification part is provided on the side, the identification part is clear as compared with the case where the identification part is provided on the corner, and it becomes possible to identify the front and back more reliably.
  • the said main-body part is circular, and the said identification part is provided with two or more on the periphery of the said main-body part.
  • the main body portion is circular, it is possible to identify the front and back by providing a plurality of identification portions.
  • the main body portion is a non-linear symmetric graphic having no line symmetry axis in the contour shape, and the identification portion is provided at an arbitrary position of the main body portion.
  • the main body portion is a non-linear symmetric graphic, it is possible to distinguish the front and back only by the shape of the main body portion, but by further providing the identification portion, both the shape of the main portion and the position of the identification portion It is possible to more reliably identify the front and back.
  • the present invention is the method for producing an amniotic membrane according to any one of the above, wherein the identification portion is shaped by a cutting means.
  • the identification portion can be formed by the cutting process, the identification portion can be easily formed.
  • one amniotic membrane is cut so that one side is convex, whereby a convex portion is formed on one of the two adjacent amniotic membrane pieces. It is preferable to form the recessed part of the shape corresponding to this convex part in the other.
  • a pair of substantially rectangular amniotic membrane pieces of erected arrangement and inverted arrangement are cut so that one side on which the convex portion and the concave portion are formed face each other and face each other.
  • the amniotic membrane pieces of the erected arrangement and the inverted arrangement be paired so that one convex portion and the other concave portion overlap with each other.
  • the said cutting means is a laser beam cutter.
  • the identification unit is the hole, and the main body be irradiated with a laser beam having a diameter substantially the same as or smaller than the diameter of the hole.
  • the identification unit is the hole, and the main body be irradiated with a laser beam having a diameter substantially the same as or smaller than the diameter of the hole.
  • the present invention is the method for producing an amniotic membrane according to any one of the above, further comprising: a cutting step of cutting a plurality of different types of amniotic membrane pieces from different lots from the amniotic membrane; At least one of the height, the shape, and the position, for each lot.
  • the lot can be identified.
  • an amniotic membrane piece having high visibility and easy discrimination between the front and back, and capable of being manufactured inexpensively, and a method for manufacturing the same.
  • the dried amniotic membrane pieces obtained by drying the amniotic membrane and the method for producing the same are described.
  • the amniotic membrane pieces of the present invention are not limited to dried amniotic membrane pieces, and ordinary amniotic membrane pieces that are not dried Also included are wet amniotic membrane pieces immersed in a preservation solution or the like.
  • FIG. 1 is a plan view of an amniotic membrane showing an embodiment in which the identification portion is a projection
  • FIG. 1 (a) is a triangle for the identification projection
  • FIG. 1 (b) is an arc
  • FIG. 1 (c) Is a rectangle
  • FIG. 2D is an embodiment having a plurality of identification units.
  • a convex portion is provided on a part of a rectangular amniotic membrane which is a line symmetrical figure, and the amniotic membrane is shaped into a substantially rectangular shape to make the amniotic membrane non-linearly symmetric. It makes it possible to identify.
  • the amniotic membrane piece 11-1 includes a main body portion 13 and a convex portion (identification portion) 15.
  • the main body portion 13 is a main portion constituting the amniotic membrane piece 11-1
  • the convex portion 15 is a means used for identifying the front and back of the main body portion 13.
  • the main-body part 13 has the edge part which divides the outline shape in planar view, and an outline shape is rectangular shape (square shape) in this embodiment.
  • the size of the main body portion 13 is not particularly limited, and may be various sizes according to the application, but when used for regenerative treatment, for example, 1 ⁇ 1 cm, 2 ⁇ 2 cm, etc. Besides small squares, large squares such as 5 ⁇ 5 cm, rectangles such as 2 ⁇ 3 cm, and the like can be exemplified.
  • the main body portion 13 has a rectangular shape, and an end portion is constituted by four sides 13a to 13d. Further, the main body portion 13 has four line symmetrical axes Xa to Xd, and is line symmetrical in plan view by these line symmetrical axes Xa to Xd. That is, the main body portion 13 can be said to have a line-symmetrical figure as its contour shape (shape divided by the sides 13 to 13 d).
  • the line symmetry axis Xa is a center line passing through the middle points of the two opposing sides 13a and 13b of the main body 13, and the line symmetry axis Xb is a pair of two opposing sides 13c and 13d. It is a center line passing through the middle point.
  • the line symmetry axis Xc is a diagonal line passing through the angle between the side 13a and the side 13d and the angle between the side 13b and the side 13c.
  • the line symmetry axis Xd is an angle between the side 13a and the side 13c and the side 13b. And a diagonal line passing through an angle formed by the side 13 d.
  • the convex part 15 is a means which enables identification of the front and back, and corresponds to the identification part of this invention.
  • the convex part 15 of this embodiment is an isosceles triangle, and is provided in a part of side 13b.
  • the size of the isosceles triangle is not particularly limited. For example, when the main body portion 13 is 1 ⁇ 1 cm, the distance (height) to the apex angle of the convex portion 15 is 1 to 3 mm with the side 13 b as the base The inside is preferable, and a degree of 2 mm is more preferable. If the size of the convex portion 15 is small, the visibility is deteriorated and the discrimination between the front and back is likely to be difficult.
  • the size of the convex portion 15 is large, a portion which is wasted when manufacturing a plurality of the amniotic membrane pieces 11-1 is increased. That is, when a plurality of amniotic membrane pieces are cut out from one amniotic membrane, the amniotic membrane pieces 11-1 of the rectangular main body portion 13 as in the present embodiment are originally cut into the amniotic membrane in a grid pattern. The amniotic membrane pieces can be cut out without waste (with good yield).
  • the amniotic membrane piece 11-1 of the present embodiment is provided with the convex portions 15 projecting from the side 13b, the convex portions 15 between the convex portion 15 of one amniotic membrane piece and the side of the amniotic membrane piece adjacent thereto.
  • the other portions are not included in the main body portion 13 and are wasted. Therefore, if the size of the convex portion 15 is too large, the portion to be wasted increases, and the yield tends to deteriorate in the manufacturing process.
  • the convex portion 15 is provided in the main body portion 13 such that two regions divided across the respective line symmetry axes Xa to Xd are non-linearly symmetrical on all the line symmetry axes Xa to Xd.
  • the convex portion 15 is provided on one side 13 b of eight regions divided by the line symmetry axes Xa to Xd, and not on the line symmetry axes Xa to Xd.
  • the main body portion 13 has the convex portion 15 which is the identification portion, which makes it possible to distinguish between the front and back.
  • the contour shape of the main body portion 13 is congruent on the front surface and the back surface.
  • “Symmetry is broken” is identified so that there is no mathematical congruence with other areas in at least one of the areas divided by the line symmetry axis (so that mathematical congruence conditions are not satisfied) It can be reworded as providing a part.
  • “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.
  • amniotic membrane is isotropic and relatively soft even if it is a dried product
  • the identification portion can be easily processed since it can be easily processed into any shape. Therefore, amniotic membrane pieces that can be identified on the front and back sides can be easily manufactured 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 13 a to 13 d) of the main body portion 13, but a position not on the line symmetry axes Xa to Xd as in this embodiment. Is preferred. When the convex portion 15 is disposed on the line symmetry axes Xa to Xd, the position of the convex portion 15 approximates on the front surface and the rear surface, and the front / back discrimination tends to be difficult.
  • the user In order to identify the front and back of the amniotic membrane piece 11-1, the user previously stores the position of the convex portion 15. Taking a case where a doctor or the like performs regenerative treatment using an amniotic membrane, for example, as shown in FIG. 1A, the convex portion 15 is above the center of the right side 13b of the rectangular main body portion 13. If the position is stored by the user such as the surface, it can be determined that it is the front if the convex 15 is located on the upper side of the right side facing the amniotic membrane piece 11-1 and the back if it is not located. . In this way, it is possible to prevent mistakes in the front and back of the amniotic membrane. Or when convex part 15 is located above the left side, it may be judged as the back.
  • the convex part 15 of this embodiment is a site
  • the position of the convex portion 15 may be shifted to any position within the side 13b as long as the symmetry of the area divided with the line symmetry axes Xa to Xd is broken. Further, the size of the convex portion 15 can be arbitrarily changed.
  • the term "lot” as used herein is the smallest unit in the process of producing amniotic membrane pieces, and the amniotic membrane pieces of the same lot mean those manufactured from amniotic membrane of the same origin and having the same shape in the main part.
  • the lot distinguishable at the position of the convex portion 15 for example, when the convex portion 15 is above the center of the side 13b, the A lot (first lot), and the convex portion 15 above the center of the side 13b. When it has, it can be made distinguishable like B lot (2nd lot).
  • the case of the convex portion 15 is 2 mm
  • the case of C lot (third lot) and the height of the convex portion 15 is 1 mm Can be identified as lot C (fourth lot).
  • 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.
  • 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, the respective small pieces , It is possible to identify the front and back and the lot.
  • FIGS. 1 (b) and 1 (c) an amniotic membrane piece according to a modification of the present embodiment is shown in FIGS. 1 (b) and 1 (c).
  • a circular arc shaped convex portion 16 as a discriminating portion
  • a rectangular convex portion 17 as a discriminating portion It is provided in the part 13.
  • Both the size of the amniotic membrane piece 11-2 and the amniotic membrane piece 11-3 can be, for example, 1 ⁇ 1 cm, as in FIG. 1A, and the height of each of the convex portions 16 and 17 is 2 mm. It can be done.
  • the size of the amniotic membrane piece 11-2 and the amniotic membrane piece 11-3 is not limited to 1 ⁇ 1 cm, and may be another size. Thus, according to the present invention, it is possible to identify the front and back surfaces of the amniotic membrane piece in the same manner as the triangular convex portion 15 shown in FIG. Become.
  • FIG. 2 (d) An amniotic membrane piece according to another modification of the amniotic membrane piece of the present invention is shown in FIG. 2 (d).
  • the amniotic membrane piece 11-4 of this modification is provided with a triangular convex portion 15 and a rectangular convex portion 17 on the side 13b as an identification portion.
  • identification portion As described above, by providing the convex portions in the shape of a rectangle, a triangle, or an arc mentioned in the other modified example as the identification portion in a mixed manner, identification of the front and back becomes easier.
  • the lot identification of amniotic membrane pieces can also be enabled by changing at least one of the position, shape, and size of the convex portion.
  • determination part is not restricted to these shapes, It is also possible to use a complicated polygon. However, it should be noted that in the case of an overly complex polygon, the identification may decrease.
  • the width of each amniotic membrane segment is equal to the height of the triangular convex portion 15 (for example, 2 mm)
  • the amniotic membrane of that width will be wasted wastefully because the cutting process must be performed separately.
  • the main body portion is 1 ⁇ 1 cm in size
  • the waste portion corresponds to 20% of the area of the amniotic membrane piece, and a considerable portion is wasted.
  • an amniotic membrane piece 11-1 'in an inverted arrangement obtained by rotating an amniotic membrane piece 11-1 in an upright arrangement by 180 degrees is adjacent to the amniotic piece 11
  • the convex part 15 of -1 and convex part 15 'of amniotic membrane piece 11-1' may be located in the same side.
  • the peripheral portions of the convex portions 15 and 16 ' can be shared by the adjacent amniotic membrane pieces 11-1 and the amniotic membrane pieces 11-1', and the discarded portion can be halved.
  • the shape of the amniotic membrane piece 11-1 is rectangular, by providing the convex portion 15 on the short side, it is possible to further reduce the portion to be discarded.
  • FIG. 3 is a flow chart showing the manufacturing process of amniotic membrane pieces from acquisition of amniotic membrane to drying and shipping.
  • Amniotic membrane obtained by natural labor and cesarean section is provided via the hospital.
  • the acquisition status, blood type of mother and child, shape, thickness, degree of contamination, etc. are recorded in a database of a computer and registered (amniotic membrane acquisition / registration process).
  • amniotic membrane is inspected (examination step), disinfected and cleaned (disinfection and cleaning step), and then pre-cut for placing on the drying table, and the sheet having a size capable of placing the amniotic membrane on the drying device table (amniotic sheet Cut into pieces) (pre-cutting step).
  • the amniotic membrane sheet is placed in a drying apparatus and dewatered and dried to form a dried amniotic sheet (dewatering and drying step). After this process is completed and the dried amniotic membrane sheet is taken out of the drying apparatus, it is cut into a desired size to form amniotic membrane pieces, and lots are recorded in a database etc. (cut and lot recording process).
  • amniotic membrane pieces and desiccants are put in and packaged (packaging step), and then shipped to a hospital etc. (shipping step).
  • the amniotic membrane after drying is cut to cut out the amniotic membrane piece having the identification portion.
  • the shape processing of the amniotic membrane piece is not a simple rectangular shape processing, but a cutting processing of a complicated shape is required so as to form the convex portions 15 to 17 which are identification portions.
  • an automatic laser beam cutter is used.
  • the automatic laser beam cutter is a device for irradiating and cutting a laser beam, and is a fully automatic device for automatically cutting a preprogrammed shape.
  • the amniotic membrane is a semitransparent membrane having a pale yellow color, and absorbs a fundamental wave (wavelength: 1.064 ⁇ m) of the YAG laser well, so a small-sized YAG laser device of 1 watt or less can be used.
  • This laser beam cutter so as to scan along the shape of the desired amniotic membrane, it becomes possible to form the main body portion and the convex portion of the amniotic membrane piece continuously and efficiently.
  • pre-programming the movement of the laser beam it is possible to freely process even an identification part of a complicated shape.
  • amniotic membrane piece cutting method is not limited to the automatic laser beam cutter, and cutting with an ordinary cutter knife or scissors may be performed. Further, in the present embodiment, although the amniotic membrane pieces are cut with respect to the dried amniotic membrane, the present invention is not limited thereto, and the amniotic membrane before drying may be cut.
  • amniotic membrane obtained in hospitals etc. has an irregular shape of several tens of centimeters or more, and even in the pre-cutting, the peripheral portion is left as much as possible so as not to waste as much as possible. It is not Therefore, it may be difficult to cut automatically in the cutting process after drying, and at that time, the process may be semi-automatically cut including installation by a person on a cutting machine.
  • FIG. 4 is a plan view showing the amniotic membrane piece in which the identification portion is a recess.
  • FIG. 4 (a) is a triangle with a recess
  • FIG. 4 (b) is an arc with a recess
  • FIG. 4 (c) is a rectangle with a recess.
  • FIG. 4 (d) shows an embodiment in which the corner is cut out.
  • the convex portion protruding outward from the end of the main body is used as the identification portion, thereby breaking the line symmetry of the square and making it possible to identify the front and back.
  • the main body By using the recess recessed inward from the end of the portion as the identification portion, the line symmetry of the main portion can be broken to identify the front and back.
  • the main body portion 13 is rectangular, and has four line symmetrical axes Xa to Xd.
  • the recess 24 of the present embodiment is provided in a region on one side 13 b of eight regions divided by the line symmetry axes Xa to Xd and not on the line symmetry axes Xa to Xd.
  • the recess 24 in this embodiment may be a right triangle having a height of 2 mm, but is not limited to this and may have a height of 1 mm or the like.
  • "height" here means the distance to the apex angle of the recessed part 24 by making the side 13b into a base.
  • the position of the recess 24 can be any position in the side 13b as long as the symmetry of the main body 13 is broken and the position is axisymmetric.
  • This recess 24 makes it possible to identify the front and back, and in the case of manufacturing a plurality of amniotic membrane pieces, it is possible to identify the lot by changing the position and the size of the recess 24 which is the identification part , It is the same as that of the first embodiment.
  • the size of the main body portion 13 is not limited to 1 ⁇ 1 cm described above, and may be a rectangle such as 2 ⁇ 3 cm or a large 5 ⁇ 5 cm. Further, as the length of the side 13 b forming the concave portion 24 becomes longer, the visibility of the lot difference can be increased, and it becomes possible to distinguish many lots.
  • the identification portion is a concave portion
  • processing can be performed only by cutting out the end portion of the main body portion as compared with the convex portion as in the above-described first embodiment, and therefore a portion which is wasted in cutting It is only the part of this notch. Therefore, in the present embodiment, the discarded portion of the amniotic membrane is smaller than in the case of forming the above-mentioned convex portion, and the use area efficiency is good.
  • a plurality of recesses 24 may be provided on the side 13 b, and in such a case, the shape and position of the recesses 24 may be variously changed. This makes it possible to distinguish more lots when producing a plurality of amniotic membrane pieces. Further, even in the case of amniotic membrane pieces of a large size, the triangular concave portions 24 of the present embodiment make it possible to distinguish the front and back surfaces.
  • the amniotic membrane piece 21-1 of the present embodiment can be manufactured by using an automatic laser beam cutter using a YAG laser, as in the first embodiment described above. As described above, by using the automatic laser beam cutter, the end portion and the recess portion of the main body can be shaped continuously.
  • FIG. 4 (b) to FIG. 4 (d) an amniotic membrane piece according to a modification of the present embodiment is shown in FIG. 4 (b) to FIG. 4 (d).
  • the amniotic membrane piece 21-2 (FIG. 4 (b)) has an arc-shaped concave portion 25 as a discriminating portion
  • the amniotic membrane piece 21-3 (FIG. 4 (c)) has a rectangular concave portion 26 as a discriminating portion.
  • the size of each of ⁇ 2 and amniotic membrane 21-3 can be, for example, 1 ⁇ 1 cm, and the height of each of the recesses 25 and 26 can be 2 mm. This makes it possible to identify the front and back as in the triangular recess 24.
  • the size of the amniotic membrane piece 21-2 and the amniotic membrane piece 21-3 is not limited to 1 ⁇ 1 cm, and may be another size.
  • these amniotic membrane pieces can also be shaped using an automatic laser beam cutter, as in the embodiment described above.
  • the corner of the main body 13 may be cut away to form a recess 27, which may be used as an identification unit.
  • the corner of the main body portion 13 is cut into a triangle, and the shape is left and right asymmetric with respect to the diagonal of the main body portion 13.
  • the notch angle of the recess 27 with respect to the corner of the main body portion 13 can be any angle as long as the front and back can be distinguished. In the case of producing a plurality of amniotic membrane pieces, lot identification can also be made by changing this notch angle.
  • the shape of the identification portion 13 when the corners of the main body portion 13 are notched to form the identification portion, the shape changes depending on the notch angle to give diversity, but in the shape change due to the notch of the angle It is generally difficult to make it so versatile. For this reason, the discrimination between the front and back by the shape of the identification portion and the lot identification in the case of producing a plurality of amniotic membrane pieces are more complicated shapes such as providing the identification portion on the side as in the embodiment described above. It tends to be difficult compared to the identification unit. Moreover, since the corner part of the main-body part 13 is a part which a bending
  • an automatic laser beam cutter can be used similarly to 1st Embodiment, it is needless to say that it is not limited to this.
  • the present embodiment since a part of the rectangular shape is cut away to form a desired shape, there is no convex portion, and a plurality of amniotic membrane pieces in an upright arrangement 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 adjacent amniotic membrane pieces like the convex portion of the first embodiment, the yield in the manufacturing process is relatively compared to that of the amniotic membrane pieces of the first embodiment. Good.
  • FIG. 5 is a plan view showing an amniotic membrane piece having a convex portion and a concave portion as an identification portion
  • FIG. 5A shows an embodiment in which both the convex portion and the concave portion are rectangular.
  • the main body 13 has a rectangular (square) shape, and has four line symmetrical axes Xa to Xd. It is provided on one side 13 b of eight regions divided by the line symmetry axes Xa to Xd and not on the line symmetry axes Xa to Xd.
  • the convex portion 17 and the concave portion 26 are provided as the identification portion.
  • the convex portion 17 of the present embodiment is provided on one side 13 b of eight regions divided by the line symmetry axes Xa to Xd and is not provided on the line symmetry axes Xa to Xd, and the recess 26 is It is provided in a region which is on one side 13b of eight regions divided by the line symmetry axes Xa to Xd and not on the line symmetry axes Xa to Xd.
  • the convex portion 17 and the concave portion 26 are respectively provided in different areas of eight areas divided by the line symmetrical axes Xa to Xd.
  • the convex portion 17 and the concave portion 26 have a rectangular contour shape, and the contour shapes of the both are congruent, and when the convex portion 17 and the concave portion 26 are butted, a gap is not generated.
  • the convex part 17 and the recessed part 26 of this embodiment can all be made into the rectangular shape of height 2 mm, it is not limited to this, For example, it is good also as height 1 mm etc.
  • the convex portion 17 of the amniotic membrane piece 31-1 and the concave portion 26 'of the amniotic membrane piece 31-1', the concave portion 26 of the amniotic membrane piece 31-1 and the convex portion 17 'of the amniotic membrane piece 31-1' The shape is processed so as to be in mutually opposing positions. Thereby, the amniotic membrane piece 31-1 having the uneven portion and the amniotic membrane piece 31-1 'obtained by rotating it by 180 degrees can be simultaneously manufactured. Further, in this case, since the convex portions and the concave portions of the respective amniotic membrane pieces correspond to each other, there is no waste portion at all, and the amniotic membrane can be efficiently used.
  • a plurality of amniotic membrane pieces may be lined up and attached to the affected area.
  • the contours of the convex portion 17 and the concave portion 26 are congruent.
  • the concave and convex portions of the amniotic membrane piece are butted and attached to the affected part, no gap is generated between the amniotic membrane pieces. As a result, air infection or the like through the gaps between the amniotic membrane pieces is less likely to occur.
  • the amniotic membrane piece of the present embodiment can also be produced by an automatic laser beam cutter programmed to follow the uneven portion as in 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 any position in the side 13 b, the symmetry can be kept broken. Thereby, it is possible to easily produce a plurality of states for lot identification. Furthermore, in the present embodiment, although the convex portion 17 and the concave portion 26 having a rectangular shape are used, the present invention is not limited thereto, and any shape may be used as long as it has a shape such as an arc shape or a rectangular shape that maintains mathematical congruence with each other. Can also be used. Moreover, in this embodiment, although the position of the convex part 17 and the recessed part 26 was on the same side 13b, you may arrange so that it may become on a different side.
  • lot identification can also be performed by changing at least one of the shape, size, and position of the identification unit for each lot.
  • FIG. 6 is a plan view showing the amniotic membrane piece of which the identification part is a hole; FIGS. 6 (a) and 6 (c) are rectangular in the main part and FIG. 6 (b) is a square in the main part. It is a form.
  • the main body 43 is a rectangular line symmetrical figure, and has two line symmetrical axes Xa and Xb.
  • the line symmetry axis Xa is a center line passing through the middle points of the two opposing sides 43a and 43b
  • the line symmetry axis Xb is a center line passing through the middle points of the two opposing sides 43c and 43d.
  • the identification portion in the present embodiment is a hole 46 formed inside the sides (ends) 43a to 43d of the main body 43.
  • the hole 46 of the present embodiment is circular, and is provided at the periphery of one of four regions divided by the line symmetry axes Xa and Xb.
  • the size of the main body 43 may be, for example, 1 ⁇ 2 cm, but is not limited thereto.
  • the size of the hole 46 may be, for example, 0.5 mm in diameter, but is not limited thereto, and may be 1 mm, 2 mm, or the like.
  • the position of the hole 46 is provided at a position close to the corner formed by the side 12 b and the side 13 a, but this 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 in the range of about 1 to 5 mm from each of the side 43 b and the side 43 d.
  • FIG. 6 (b) shows another modification of this embodiment.
  • the shape of the main body portion 13 of the amniotic membrane piece 41-2 is substantially rectangular (square), and the size thereof can be, for example, 1 ⁇ 1 cm.
  • the hole 46 is substantially circular, and it is difficult to identify the front and back by the shape of the hole 46 itself. Therefore, the hole 46 is formed at a position avoiding the line of the line symmetry axes Xa to Xd.
  • the hole 46 may be provided anywhere on the main body 13 unless the center is located on the line of the line symmetrical axes Xa to Xd, and a plurality of holes may be provided. Therefore, in the case of producing a plurality of amniotic membrane pieces, it is possible to produce a large number of amniotic membrane pieces that can be identified as lots.
  • the main body 43 has a rectangular shape having sides 43a to 43d as in FIG. 6A, but three or three types of holes 46 to 48 (circular holes 46, It is an example which has 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 non-linear shapes can be produced, whereby more lots of lots can be produced. Identification is possible.
  • the diameter and side length of these holes 46 to 48 are usually in the range of 0.1 to 2 mm and can be sufficiently identified by about 0.5 mm, and the influence of the holes in treatment is negligible. is there.
  • the holes 46 to 48 can be formed using an automatic laser beam cutter as in the above embodiment. In the case of the circular hole 46, processing can be performed using a laser beam condensed 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 of the hole for a short time.
  • the degree of light collection is further increased, and a laser beam condensed to a diameter smaller than the size of the hole is used.
  • a laser beam condensed to a diameter smaller than the size of the hole is used.
  • the present embodiment it is possible to distinguish between the front and back by simply forming the minute holes, so that it is easy to use for treatment, and the preparation process may be simple, and amniotic membrane pieces can be manufactured inexpensively. .
  • FIG. 7A is a plan view showing an amniotic membrane piece whose main body portion is circular
  • FIG. 7A shows an embodiment having two convex portions as an identification portion
  • FIG. 7B shows an embodiment having convex portions and concave portions
  • FIG. (C) is an embodiment having three convex portions and three concave portions
  • FIG. 7 (d) and FIG. 7 (e) are embodiments having a hole as an identification portion
  • FIG. 7 (f) is a convex portion, a concave portion
  • FIG. 7 (g) shows an embodiment in which a plurality of amniotic membrane pieces are cut out.
  • the main body portion 53 is a line-symmetrical figure having a substantially circular shape.
  • a circle is a line-symmetrical figure in which all lines passing through its center line are axes of line symmetry.
  • the circular main body portion 53 even if there is only one identification portion, it is possible to distinguish between the front and back depending on the shape, but if there is only one identification portion, it is necessary to discriminate the front and back only by the shape. It tends to be difficult to identify. Therefore, in the amniotic membrane piece 51-1 (FIG. 7 (a) and amniotic membrane piece 51-2 (FIG.
  • the asymmetry of the amniotic membrane piece of approximately circular shape is performed by shape processing at two locations.
  • the amniotic membrane piece 51-1 has two convex parts (identification parts) 15 and 17 having different shapes, and the amniotic membrane piece 51-2 has a triangular convex shape (identification part) 15 and a triangular shape.
  • the shape of the amniotic membrane piece is asymmetrical by providing the concave portion (identification portion) 24 of the present invention on the periphery of the circumference (end portion) of the main body portion 53, respectively.
  • each of the two identification units is disposed at a position at 90 degrees with respect to the center O of the substantially circular main body portion 53.
  • determination part is not limited to this, As long as an amniotic membrane piece can be front and back discernment, it can arrange
  • the angles formed by the two identification units are preferably other than 180 degrees. If the angle formed by the two identification parts is 180 °, the identification parts are arranged on the line symmetry axis, so the shapes of the front and back become similar and the front / back identification tends to be difficult.
  • the angle formed by the two identification parts may be an arbitrary angle other than 180 degrees. it can.
  • the difference between the angles of the two identification parts by an angle that can identify the front and back, a large number of asymmetric shapes can be obtained. Thereby, when manufacturing a plurality of amniotic membrane pieces, it is also possible to use an identification part for lot identification.
  • Amniotic membrane piece 51-3 (FIG. 7 (c)), amniotic membrane piece 51-4 (FIG. 7 (d)), amniotic membrane piece 51-5 (FIG. 5 (e)), amniotic membrane piece 51-6 (FIG. 7 (f))
  • this identification unit can also be used for lot identification when producing a plurality of amniotic membrane pieces.
  • a circular arc convex portion 16 is further provided in the main body portion 53 in the convex portion 15 and the concave portion 24 of the amniotic membrane piece 51-2 (FIG.
  • the amniotic membrane piece 51-4 (FIG. 7 (d)) has three circular holes 46, and the amniotic membrane piece 51-5 (FIG. 7 (e)) has a circular hole 46, a triangular hole 47, and a square
  • the three kinds of identification parts of the hole 48 in the main body 53 with the convex part 15, the concave part 26, and the hole 46 in the amniotic membrane piece 51-6 (FIG.
  • a substantially circular main body Asymmetry of the part 53 makes it possible to discriminate the front and back.
  • the shape processing can be suitably performed by an automatic laser beam cutter.
  • the circumferential portion of the circular main body portion 53 is disposed so as to be in contact with adjacent amniotic membrane pieces. And it is preferable to cut out so that the convex parts 15 and 17 may be located in the clearance gap between adjacent amniotic membrane pieces 51-1.
  • the main body portion 63 is a trapezoidal shape that is not an isosceles trapezoid, and is a non-linear symmetric figure in which the line symmetry axis does not exist in the contour shape.
  • a hole 46 as an identification unit is provided at an arbitrary position of the main body 63.
  • the asymmetric figure has no line symmetry axis, it is possible to identify the front and the back by itself, but in the present embodiment, an identification unit is further provided.
  • the front / back discrimination by the main body 63 which is a non-linear symmetric graphic
  • the front / back discrimination by the position of the identification portion or the like is possible, and the front / back discrimination can be 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 °. From the viewpoint of the discrimination between the front and back by the main body 63 itself, if the inclination angle of the corner 63a is 3 ° or more, the front and back can be sufficiently discriminated. On the other hand, when 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 corner 53 is preferably in the range of 3 to 10 °. In addition, in the case of operation, by sandwiching the corner 53 of this acute angle portion with a tweezer, the amniotic membrane piece can be easily grasped, and adhesion to the affected part is facilitated, which is preferable.
  • the ease of manufacturing an amniotic membrane can be mentioned. That is, as shown in FIG. 8 (b), as in the third embodiment (FIG. 5), the amniotic membrane 61-1 of the present embodiment and the amniotic membrane 61-1 'obtained by rotating the amniotic membrane 61 by 180.degree.
  • the amniotic membrane pieces can be produced simultaneously by cutting the boundary at an angle so as to sandwich the sides forming the asymmetry of the two on the inside. By this, it is possible to cut without generating a useless portion of the amniotic membrane. Further, since the cutting portion is straight, it can be cut by a cutter having a normal linear blade, but of course it may be cut by an automatic laser cutter.
  • the present invention has been described above by citing a plurality of embodiments, but the present invention is not limited to the above embodiments.
  • the number of identification parts can be three or more, and the convex part, the concave part, and the hole part can be freely combined.
  • the shape, position, and size of the identification unit can be arbitrarily changed.
  • the shape of the main body portion is not limited to the rectangular shape, the rectangular shape, the circular shape, and the trapezoidal shape described above, and various shapes can be adopted.
  • an isosceles triangle one line symmetry axis
  • an equilateral triangle three line symmetry axes
  • a rhombus two line symmetry axes
  • an ellipse eleven
  • Two symmetrical lines of line symmetry, one semicircle (one line symmetrical axis), and the like can be mentioned.
  • a parallelogram can be mentioned as another example of the outline shape of a main-body part non-linearly symmetric figure.
  • the amniotic membrane piece of the present invention is not limited to the amniotic membrane itself as long as it has at least one of the layers (membranes) constituting the amniotic membrane.
  • it may be composed of one or more tissues among amniotic epithelial tissues, basement membranes, and stromal tissues that constitute amniotic membrane, and these tissues may further have tissues or the like derived from other than amniotic membrane.
  • amniotic membrane piece of the present invention can easily identify the front and back, when used for treatment of burns and wounds, the affixing surface is not mistaken and can be appropriately used for each treatment.

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  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Materials For Medical Uses (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Prostheses (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Abstract

L'invention concerne une pièce de membrane amniotique 11-1 ayant au moins une membrane amniotique ou une des couches constitutives de la membrane amniotique, la pièce étant configurée à partir : d'une partie de corps principal 13 ayant des côtés 13a -13d qui distinguent une forme de contour dans une vue en plan ; et d'une partie d'identification qui est un moyen par lequel les côtés avant et arrière de la partie de corps principal 13 peuvent être identifiés, la partie d'identification étant une partie de saillie 15 faisant saillie vers l'extérieur à partir du côté 13b. La partie de saillie 15 a de préférence une forme triangulaire, rectangulaire ou d'arc. De plus, la partie de corps principal 13 est une figure axisymétrique ayant au moins un axe axisymétrique Xa-Xd dans la forme de contour, et la partie de saillie 15 est de préférence disposée dans une partie de la partie de corps principal 13 de sorte que pour tous les axes axisymétriques Xa-Xd, deux régions divisées avec les axes axisymétriques respectifs entre elles ne sont pas axisymétriques.
PCT/JP2017/009682 2017-03-10 2017-03-10 Pièce de membrane amniotique et sa méthode de fabrication Ceased WO2018163400A1 (fr)

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JP2019504264A JP6861444B2 (ja) 2017-03-10 2017-03-10 羊膜片及びその製造方法

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Publication number Priority date Publication date Assignee Title
CN116370165B (zh) * 2023-03-30 2023-12-29 中国人民解放军总医院第三医学中心 一种多孔隙生物羊膜穿刺设备及制备方法

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US20120010727A1 (en) * 2010-07-06 2012-01-12 AFcell Medical Amnion and chorion constructs and uses thereof in sport injury surgeries
US20120035744A1 (en) * 2010-08-04 2012-02-09 AFcell Medical Amnion and chorion constructs and uses thereof in joint repair
US20130211511A1 (en) * 2012-02-14 2013-08-15 AFcell Medical Method of using amnion allograft in heart valve replacement surgery
US20130238100A1 (en) * 2012-03-08 2013-09-12 AFcell Medical Amnion and chorion constructs and uses thereof in abdominal surgery
US20130289724A1 (en) * 2012-04-25 2013-10-31 AFcell Medical Amnion and chorion wound dressing and uses thereof
US8597687B2 (en) * 2006-08-17 2013-12-03 Mimedx Group, Inc. Methods for determining the orientation of a tissue graft

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JPH05128784A (ja) * 1991-10-31 1993-05-25 Sony Corp テープカセツト
JPH08263966A (ja) * 1995-01-27 1996-10-11 Sony Corp 記録再生用カセットの誤消去識別用カラープレート及びこのカラープレートを搭載した記録再生用カセット
JPH10106697A (ja) * 1996-09-30 1998-04-24 Mitsumi Electric Co Ltd 電気コネクタ
JP3055108U (ja) * 1998-06-19 1999-01-06 モリト株式会社 テープ付き雌スナップ
JP2001266903A (ja) * 2000-03-21 2001-09-28 Matsushita Electric Ind Co Ltd 偏平型電池
JP2003027780A (ja) * 2001-07-23 2003-01-29 Miwa Lock Co Ltd キー構造
JP2005234415A (ja) * 2004-02-23 2005-09-02 Nidec Copal Corp レンズ鏡筒
JP2007049047A (ja) * 2005-08-11 2007-02-22 Hitachi Cable Ltd 半導体形成用基板、窒化物系半導体基板およびその製造方法
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US8597687B2 (en) * 2006-08-17 2013-12-03 Mimedx Group, Inc. Methods for determining the orientation of a tissue graft
US20120010727A1 (en) * 2010-07-06 2012-01-12 AFcell Medical Amnion and chorion constructs and uses thereof in sport injury surgeries
US20120035744A1 (en) * 2010-08-04 2012-02-09 AFcell Medical Amnion and chorion constructs and uses thereof in joint repair
US20130211511A1 (en) * 2012-02-14 2013-08-15 AFcell Medical Method of using amnion allograft in heart valve replacement surgery
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