Medical sheet and producing method of medical sheet

Abstract

To provide a medical sheet capable of preventing or suppressing occurrence of twisting and lag, improving punchability, and easily forming a through hole, and a producing method of the medical sheet.SOLUTION: A medical sheet 100 has: a sheet-like main body part 10 that has a first surface 10a and a second surface 10b containing fibers composed of biodegradable materials; and a plurality of through holes 11 having openings 11a and 11b on the first and second surfaces of the main body part. The medical sheet further has a fused part 60 formed between the openings of the plurality of through holes, where the fibers are melted together in a surface direction YZ.SELECTED DRAWING: Figure 10

Description

[Technical field]

[0001] The present invention relates to a medical sheet and a method for manufacturing a medical sheet. [Background technology]

[0002] In the medical field, there are known surgical procedures for joining biological organs together (e.g., anastomosis of the digestive tract). When such procedures are performed, it is known that the absence of delayed healing at the joint where the biological organs are joined is an important factor in determining the postoperative prognosis.

[0003] Various methods and medical instruments are used in the procedure of anastomosis of biological organs, and for example, a method of suturing biological organs with biodegradable sutures and a method of using a mechanical anastomosis device that performs anastomosis with a stapler have been proposed. In particular, when performing anastomosis using a mechanical anastomosis device, the joining strength between biological organs at the joint can be increased compared to a method using sutures, making it possible to reduce the risk of suture failure. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Special Publication No. 2008-516678 Summary of the Invention [Problem to be solved by the invention]

[0005] In the anastomosis device of Patent Document 1, healing of the anastomosis site is promoted by sandwiching a sheet-like member (hereinafter referred to as a medical sheet) such as a support structure in order to prevent leakage or tearing at the anastomosis site.

[0006] Also known is a technique for forming through holes in a medical sheet in order to promote the adhesion effect of the medical sheet.

[0007] Such medical sheets are relatively soft. For this reason, the medical sheet is prone to twisting (bending or folding, making it not flat) or shifting during handling or placement on a living organ. When performing anastomosis using a mechanical anastomosis device, when punching out a part of the medical sheet, the fibers are not punched out (not cut out), and fraying of the fibers (a state in which the fibers are loose at the cut ends) is likely to occur. Furthermore, it is difficult to form through holes, and the shape of the formed through holes is easily distorted.

[0008] Therefore, an object of the present invention is to provide a medical sheet and a method for manufacturing a medical sheet in which the occurrence of twisting or shifting can be prevented or suppressed, punching properties can be improved, and through holes can be easily formed. [Means for solving the problem]

[0009] The present invention can be achieved by any one of the following means (1) to (11).

[0010] (1) A medical sheet having a sheet-like main body having a first surface and a second surface including fibers made of a biodegradable material, a plurality of through holes having openings on the first surface and the second surface of the main body, and fused portions formed between the openings of the plurality of through holes and in which the fibers are fused together in the planar direction.

[0011] (2) The medical sheet according to (1) above, wherein the fused portion is formed around the opening of at least some of the plurality of through holes.

[0012] (3) The through hole has an inner surface formed along a thickness direction of the main body, The medical sheet according to (1) or (2) above, further comprising another fused portion formed on at least a part of the inner surface, the other fused portion being formed by fusion of the fibers together in the thickness direction.

[0013] (4) The through hole has an inner surface formed along a thickness direction of the main body, The medical sheet according to (1) or (2) above, wherein the inner surface has a cross-sectional portion which is a cut surface of the fibers.

[0014] (5) The medical sheet according to (4) above, wherein the fused portion is formed on the cross-sectional portion.

[0015] (6) The medical sheet according to any one of (1) to (5) above, wherein the main body portion comprises a thermoplastic material on the first surface and the second surface.

[0016] (7) applying heat while applying pressure to the first surface and the second surface of a sheet member having a first surface and a second surface containing fibers made of a biodegradable material, to form a fused portion in which the fibers are fused to each other in a planar direction in a part of at least one of the first surface and the second surface; A method for manufacturing a medical sheet, comprising forming a plurality of through holes on the first surface and the second surface of the sheet member after the fused portion has been formed.

[0017] (8) The method for producing a medical sheet according to (7) above, wherein the fused portions are formed by heating the sheet member to a temperature equal to or higher than the temperature at which the fibers melt.

[0018] (9) The method for producing a medical sheet according to (7) above, wherein the fused portions are formed by heating the sheet member to a temperature equal to or higher than the melting point of the fibers.

[0019] (10) The method for producing a medical sheet according to any one of (7) to (9) above, wherein the sheet member is formed by stacking a plurality of sheet materials containing the fibers.

[0020] (11) The method for manufacturing a medical sheet according to any one of (7) to (9) above, wherein the sheet member is formed by stacking multiple sheets of sheet material containing the fibers, needle-punching the stacked sheets, and entangling the fibers of the sheet material with each other before the needle-punching. Effect of the Invention

[0021] According to the medical sheet and the method for manufacturing the medical sheet according to one aspect of the present invention, the rigidity of the main body can be increased by the fused parts, twisting or shifting of the medical sheet can be prevented or suppressed, and fraying of the fibers can be prevented or suppressed by improving punching properties. In addition, through holes can be easily formed and the shape of the through holes can be easily maintained. [Brief description of the drawings]

[0022] [Figure 1] FIG. 1 is a perspective view showing a medical sheet according to an embodiment. [Diagram 2] 4 is an enlarged cross-sectional view showing a through hole in a main body portion of the medical sheet. FIG. [Diagram 3] FIG. 2 is a diagram showing a shape pattern of through holes in a medical sheet. [Figure 4] 13A to 13C are diagrams showing modified shape patterns of through holes in a medical sheet. [Diagram 5] 13A to 13C are diagrams showing modified shape patterns of through holes in a medical sheet. [Figure 6] 13A to 13C are diagrams showing modified shape patterns of through holes in a medical sheet. [Figure 7] FIG. 2 is a perspective view showing a medical sheet according to a modified example of FIG. [Figure 8] FIG. 2 is an exploded perspective view showing a part (tip portion) of a medical instrument used when anastomosing biological organs using a medical sheet. [Figure 9] FIG. 2 is an enlarged perspective view showing a main portion of the medical sheet. [Figure 10] FIG. 4 is an enlarged cross-sectional view showing a fused portion and a through hole. [Figure 11] 4 is a cross-sectional view showing a sheet member in a state in which a fused portion has been formed. FIG. [Figure 12] 3 is a flowchart showing a method for manufacturing a medical sheet according to the embodiment. [Figure 13] 5A to 5C are schematic diagrams illustrating a state in which a fused portion is formed on a sheet member. [Figure 14] 10A and 10B are schematic diagrams illustrating a state in which through holes are formed in a sheet member after a fused portion is formed. [Figure 15] 13 is a cross-sectional view showing a main portion of a medical sheet according to a modified example. FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] First Embodiment Hereinafter, the embodiments for carrying out the present invention will be described in detail with reference to the drawings. The embodiments shown here are merely illustrative in order to embody the technical idea of ​​the present invention, and do not limit the present invention. Furthermore, all other possible embodiments, examples, and operating techniques that can be conceived by those skilled in the art without departing from the gist of the present invention are included in the scope and gist of the present invention, and are included in the scope of the inventions described in the claims and their equivalents.

[0024] Furthermore, for the convenience of illustration and ease of understanding, the drawings attached to this specification may be represented diagrammatically with appropriate changes in scale, aspect ratio, shape, etc. from the actual product; however, these are merely examples and are not intended to limit the interpretation of the present invention.

[0025] In the following description, ordinal numbers such as "first" and "second" are used, but unless otherwise specified, these are used for convenience and do not dictate any order.

[0026] <Medical Sheet> FIG. 1 is a perspective view showing a medical sheet 100 according to an embodiment. FIG. 2 is an enlarged view showing a through hole 11 of the medical sheet. The medical sheet 100 is sandwiched and disposed between two or more biological organs to be anastomosed (one part to be joined and the other part to be joined), and is configured in a flat sheet shape with a plurality of through holes 11 formed therein. Here, "sandwiched and disposed between two or more biological organs to be anastomosed" means at least one of the following: the medical sheet 100 is disposed in direct or indirect contact with the biological organs, the medical sheet 100 is disposed in a state in which a spatial gap is formed between the biological organs, or the medical sheet 100 is disposed in both of these states (for example, the medical sheet 100 is disposed in a state in which it is in contact with one biological organ and not in contact with the other biological organ). Examples of biological organs include tubular organs such as the large intestine, the jejunum, and the pancreatic duct. As shown in Fig. 1 etc., the medical sheet 100 comprises a main body portion 10, a reinforcing portion 20, a fixing portion 30, a hole portion 40, and a fused portion 60. The medical sheet 100 may not comprise the reinforcing portion 20 and the fixing portion 30, but may comprise the main body portion 10, the hole portion 40, and the fused portion 60. Alternatively, the medical sheet 100 may not comprise the reinforcing portion 20, but may comprise the main body portion 10, the fixing portion 30, the hole portion 40, and the fused portion 60. Some of the drawings show an orthogonal coordinate system, and hereinafter, the surface direction of the main body portion 10 is referred to as the surface direction YZ, and the thickness direction is referred to as the thickness direction X. This will be described in detail below.

[0027] <Main body> The main body portion 10 is disposed between biological organs to be anastomosed (for example, between large intestines, or between the pancreatic duct and the jejunum), and is configured in a sheet shape capable of following the movement of the biological organs to be anastomosed.

[0028] The main body 10 is formed in a circular shape as shown in FIG. 1, and has a plurality of through holes 11 formed to pass through the circular shape in the thickness direction X (axial direction) as shown in FIG. 2. The size (hole diameter D) of the through holes 11 of the main body 10 is preferably 0.1 to 6 mm, more preferably 0.3 to 4 mm, and further preferably 0.6 to 1.5 mm. The main body 10 can promote healing effect by the through holes 11. The through holes 11 can be configured so that the ratio of the size of the through holes 11 (the distance shown in FIG. 2, the hole diameter D of the through holes 11) to the pitch P (the distance shown in FIG. 2, the distance between the opening edges of two through holes 11) is 0.25 or more and less than 40. Since the main body 10 has a plurality of through holes 11, there are a plurality of values ​​of the hole diameter D corresponding to each through hole 11. Therefore, in this embodiment, when calculating the value of the above-mentioned ratio, the arithmetic average value of two or more values ​​of the hole diameter D corresponding to each of the plurality of through holes 11 is used as the representative value of the hole diameter D. On the other hand, the pitch P of the multiple through holes 11 is defined as the shortest distance between the openings of two through holes 11. However, there are also multiple values ​​of the pitch P corresponding to the combination of adjacent through holes 11. Therefore, in this embodiment, when calculating the above-mentioned ratio, the arithmetic average value of two or more points of the pitch P values ​​corresponding to the combination of adjacent through holes 11 is used as the representative value of the pitch P. However, the above-mentioned pitch P is an example, and may be periodic or random. Note that the (perfect) circle described as the shape of the main body 10 is an example, and may be configured to include shapes other than the above, such as an ellipse, a polygon such as a rectangle, a star, etc.

[0029] Fig. 3 is a diagram showing a shape pattern of the through holes 11 of the main body portion 10, and Figs. 4 to 6 are diagrams showing shape patterns according to modified examples of the through holes 11 of the main body portion 10. In Figs. 2 and 3, the through holes 11 are shown with the same shape and at equal pitches. However, the shape pattern of the through holes 11 is not limited to this. In addition to the above, through holes 11 of different sizes may be arranged at equal intervals as shown in Fig. 4, through holes of the same size may be arranged at a 60° staggered pitch (staggered arrangement) as shown in Fig. 5, or through holes 11 of different sizes may be arranged randomly as shown in Fig. 6.

[0030] The thickness of the main body 10 (dimension T shown in FIG. 2) is not particularly limited, but is preferably 0.05 to 0.7 mm, and more preferably 0.25 to 0.45 mm. The above-mentioned values ​​for the thickness, size, and other dimensions are also examples, and other dimensions may be used. When the dimension T, which is the thickness of the main body 10, is 0.7 mm or less (particularly when it is 0.45 mm or less), the flexibility of the main body 10 can be increased. This allows the main body 10 to adhere closely to the biological organ, and improves its ability to follow the movement of the biological organ. On the other hand, when the dimension T, which is the thickness of the main body 10, is 0.05 mm or less, the strength of the main body 10 is insufficient, and the medical sheet 100 becomes twisted, making it difficult to place it between the biological organs to be anastomosed.

[0031] The main body 10 can be formed from a sheet-like molded product made by knitting or weaving a multifilament of multiple fibers (e.g., threads) made of a biodegradable material as a starting material. That is, the main body 10 can be formed from a biodegradable sheet. There are no particular limitations on the material of the main body 10, and examples of the material include biodegradable resins.

[0032] Examples of biodegradable resins include (1) polymers selected from the group consisting of aliphatic polyesters, polyesters, polyanhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphates, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and cellulose; and (2) copolymers composed of one or more monomers constituting the above (1).

[0033] That is, the biodegradable sheet preferably contains at least one biodegradable resin selected from the group consisting of polymers selected from the group consisting of aliphatic polyesters, polyesters, polyanhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphates, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and cellulose, and copolymers composed of one or more monomers constituting the polymers. The main body 10 is preferably made of a bioabsorbable material such as polyglycolic acid (PGA) or PLGA (polylactic acid-glycolic acid copolymer).

[0034] The main body 10 is produced by forming a sheet made of biodegradable fibers into a nonwoven fabric, and then subjecting the sheet to a process of forming the through-holes 11 involving heating. The main body 10 produced in this manner induces a biological reaction by the constituent materials, such as biodegradable resin, that constitute the main body 10. The main body 10 induces the expression of biological components, such as fibrin, through this action. The biological components induced in this manner can be accumulated by penetrating the through-holes 11 of the main body 10 from both sides in the planar direction YZ, thereby promoting healing. Therefore, by placing the main body 10 of the medical sheet 100 in a sandwiched state between biological organs to be joined (for example, between intestinal tracts that anastomose with the large intestine, between cut surfaces of intestinal tracts that anastomose with the large intestine, between the pancreatic parenchyma and the jejunum), healing is promoted by the above-mentioned mechanism.

[0035] <Reinforcement section> The reinforcing portion 20 is provided to prevent twisting, shifting, damage, falling off, etc. of the medical sheet 100 when the medical sheet 100 is placed between a first bonded portion (one bonded portion) and a second bonded portion (the other bonded portion). The reinforcing portion 20 is formed along the outer periphery of the hollow circular body portion 10.

[0036] In this embodiment, the reinforcing part 20 is configured to have higher rigidity than the main body part 10. In this embodiment, the reinforcing part 20 is configured to have a shape in which the through-hole 11 is not provided in the main body part 10. The reinforcing part 20 is preferably made of a bioabsorbable material such as a thermoplastic resin such as PGA (polyglycolic acid), PLA (polylactic acid), PLGA (polylactic acid-glycolic acid copolymer), PDS (polydioxanone), PCL (polycaprolactone), etc. However, the reinforcing part 20 may contain a material that is not bioabsorbable.

[0037] The reinforcing portion 20 may be provided over the entire circumference on the outer side of the surface direction YZ of the main body portion 10, or may be provided at one or more locations partially around the entire circumference. Here, the outer direction is the direction away from the center Pt (imaginary point) of the medical sheet 100 in the surface direction YZ. In the surface direction YZ, the direction approaching the center Pt of the medical sheet 100 is the inner direction. The reinforcing portion 20 may be bonded to the main body portion 10 by adhesive or thermal fusion, or sewn with thread or the like. The reinforcing portion 20 may not be provided. FIG. 7 is a perspective view showing a medical sheet 100a according to a modified example not including the reinforcing portion 20. As shown in FIG. 7, the medical sheet 100 may be composed of the main body portion 10, the fixing portion 30, the hole portion 40, and the fused portion 60. When the reinforcing portion 20 is not provided, the outer peripheral edge of the medical sheet 100 is composed of the main body portion 10 having the through-hole 11 that continues from the main body portion 10 in the outer direction.

[0038] 8 is an exploded perspective view showing a tip of a medical instrument 200 used when placing the medical sheet 100 on a living organ. The medical instrument 200 includes a first engaging instrument 210 and a second engaging instrument 250. The medical instrument 200 may also be called a stapler, the first engaging instrument 210 may also be called a trocar, and the second engaging instrument 250 may also be called an anvil. The reinforcing portion 20 and a part of the outer side of the main body portion 10 (the main body portion 10 in the vicinity of the inner circumference of the reinforcing portion 20) are integrated into the first and second joined portions by the staples released from the release portion 240 of the first engaging instrument 210 of the medical instrument 200 being clamped together with the clamping portion 270 of the second engaging instrument 250 facing the release portion 240 and being deformed.

[0039] <Fixed part 30> The fixing part 30 is provided to prevent or suppress the shifting of the medical sheet 100 and to prevent it from falling off when the medical sheet 100 is placed between the first and second bonded parts. The fixing part 30 is formed along the inner peripheral edge of the hollow circular shape of the main body part 10. That is, the fixing part 30 is formed so as to surround the center Pt (imaginary point) of the medical sheet 100 in the planar direction YZ. Therefore, the medical sheet 100 is composed of a circular reinforcing part 20 formed so as to surround the center Pt of the medical sheet 100, the main body part 10 formed so as to surround the outer periphery of the reinforcing part 20, and the reinforcing part 20 formed so as to surround the outer periphery of the main body part 10. The medical sheet 100 is arranged in the order of the fixing part 30, the main body part 10, and the reinforcing part 20 from the center Pt outward in the planar direction YZ.

[0040] The fixing portion 30 is configured in a shape in which no through-hole 11 is provided in the main body portion 10, similar to the reinforcing portion 20. The fixing portion 30 can be configured from the same material as the reinforcing portion 20.

[0041] The fixing part 30 may be provided around the entire circumference on the inner side of the surface direction YZ of the main body part 10, or may be provided at one or more locations partially around the entire circumference. The fixing part 30 is configured coaxially with the inner edge part, but the center position may be shifted from the main body part 10 as long as it does not enter the fusion region. The fixing part 30 and the inner side of the main body part 10 are punched out by the punching part 230 of the first engagement device 210 of the medical device 200 during the procedure, and are separated from the outer side of the main body part 10 and the reinforcing part 20. The fixing part 30 may not be provided. When the fixing part 30 is not provided, the inner peripheral edge of the medical sheet 100 is formed by the main body part 10 having the through hole 11 that continues inward from the main body part 10.

[0042] <hole> The hole portion 40 is spaced from the outer circumferential edge portion of the main body portion 10 in the surface direction YZ of the main body portion 10, and is formed by the fixing portion 30 in this embodiment. The hole portion 40 is configured so that the shaft 260 of the second engagement device 250 of the medical device 200 can be inserted therethrough. In this embodiment, the hole portion 40 has a hole diameter larger than the hole diameter D of each through hole 11, and is therefore configured so that the shaft 260 can be inserted therethrough. The shaft 260 of the second engagement device 250 is configured so that the positioning portion 220 of the first engagement device 210 can be housed therein.

[0043] In this embodiment, the hole 40 is configured to have a substantially circular shape when viewed from the thickness direction X. However, as long as the main body 10 can promote healing of biological tissues, the specific shape of the hole is not limited to a circular shape. The cross section of the hole 40 is preferably a perfect circle, but may also be configured to have a linear, elliptical, triangular, rectangular, concave, convex, cross, or other notch shape.

[0044] <Fused part> 9, 10, and 11 are explanatory diagrams used to explain the fused portion 60. Fig. 9 is an enlarged perspective view showing a main portion of the medical sheet 100. Fig. 10 is an enlarged cross-sectional view showing the fused portion and the through-holes. Fig. 11 is a cross-sectional view showing the sheet member S in a state in which the fused portion 60 has been formed.

[0045] As shown in Figs. 9 and 10, the medical sheet 100 has a sheet-like main body 10, a plurality of through holes 11, and a fused portion 60. The main body 10 has a first surface 10a and a second surface 10b containing fibers made of a biodegradable material. The plurality of through holes 11 have openings 11a, 11b on the first surface 10a and the second surface 10b of the main body 10. The fused portion 60 is formed between the openings 11a, 11a, and between the openings 11b, 11b of the plurality of through holes 11, and the fibers are fused to each other in the planar direction YZ. The fused portion 60 can be formed on a part of at least one of the first surface 10a and the second surface 10b of the main body 10. Figs. 10 and 11 show an example in which the fused portion 60 is formed on both the first surface 10a and the second surface 10b of the main body 10.

[0046] "Between the openings 11a and 11a, and between the openings 11b and 11b" means between the openings 11a on the first surface 10a or between the openings 11b on the second surface 10b when the main body 10 is viewed in plan from the first surface 10a or the second surface 10b, and does not mean between the openings 11a on the first surface 10a and the openings 11b on the second surface 10b. In the fused portion 60, the fibers may be fused to each other in the thickness direction X from the first surface 10a toward the second surface 10b, or from the second surface 10b toward the first surface 10a. Depending on the location, in the fused portion 60, the fibers may be fused to each other in the thickness direction X so as to connect the first surface 10a and the second surface 10b.

[0047] The fused portion 60 is formed around the openings 11 a , 11 b of at least some of the through holes 11 .

[0048] The fused portion 60 can have a portion where the fibers are completely fused and a portion where the periphery of the fibers is fused while maintaining the shape of the fibers. Here, "completely fused" means a state where the fibers are in a mixed state (fibers that are originally separate are integrated to such an extent that they cannot be distinguished even when viewed under a microscope, etc.). "The periphery of the fibers is fused while maintaining the shape of the fibers" means a state where the fibers are not in a mixed state (fibers that are originally separate are integrated to such an extent that they cannot be distinguished even when viewed under a microscope, etc.), but the periphery of the fibers is melted and the fibers are integrated (fibers that are originally separate are integrated to such an extent that they can be distinguished when viewed under a microscope, etc.). The presence of a portion where the periphery of the fibers is fused while maintaining the shape of the fibers makes it easier for biological components to enter the gaps between the fibers, making it easier to exert the healing effect.

[0049] The main body 10 includes a thermoplastic material on the first surface 10a and the second surface 10b. Examples of the thermoplastic material include bioabsorbable materials such as PGA (polyglycolic acid), PLA (polylactic acid), PLGA (polylactic acid-glycolic acid copolymer), PDS (polydioxanone), and PCL (polycaprolactone).

[0050] There is no particular limitation on the size of the fused portion 60. When the main body portion 10 is viewed in plan from the first surface 10a or the second surface 10b, the occupancy rate of the fused portion 60 to the main body portion 10 can be set to 0.002% or more.

[0051] 10 has an inner surface 11c formed along the thickness direction X of the main body portion 10. The medical sheet 100 further has another fused portion 70 formed on at least a part of the inner surface 11c and formed by fusing fibers together in the thickness direction X.

[0052] <Formation method> Next, a method for forming the fused parts 60 and the through holes 11 in the medical sheet 100 will be described. Fig. 12 is a flowchart showing a method for manufacturing the medical sheet 100 according to an embodiment. Fig. 13 is a schematic diagram showing how the fused parts 60 are formed in the sheet member S, and Fig. 14 is a schematic diagram showing how the through holes 11 are formed in the sheet member S after the fused parts 60 have been formed. The sheet member S is a sheet-like member that does not have through holes 11 formed therein and contains fibers made of a biodegradable material.

[0053] As shown in Fig. 12, a sheet member S containing fibers made of a biodegradable material is prepared (S1). The sheet member S has a first surface 10a and a second surface 10b. Heat is applied to the first surface 10a and the second surface 10b of the sheet member S while applying pressure, and a fused portion 60 is formed in which the fibers are fused to each other in the planar direction YZ on a portion of at least one of the first surface 10a and the second surface 10b (S2). The first surface 10a and the second surface 10b are heated by the heat press, and at least a portion of the fibers are melted to be integrated, forming the fused portion 60.

[0054] 13, when forming the fused portion 60, the sheet member S is sandwiched between a pair of heating plates 410 and pressed by a pressure member 420. One of the heating plates 410 is supported on a support base 430, and the other heating plate 410 is connected to a pressure member 420. Each of the heating plates 410 has a built-in heater member (not shown). The heater member is not particularly limited, and may be, for example, a member that generates heat by ultrasonic waves, a member that generates heat by electricity, or a member that generates heat by circulating a heat medium. The pressure member 420 may be, for example, a press machine.

[0055] The area of ​​the portion where the heat generating portion of the heating plate 410 that becomes hot is in contact with the sheet member S is preferably 30% or more of the area of ​​the sheet member S. This is because the fused portion 60 increases the rigidity of the sheet member S.

[0056] The temperature, pressure, and time for performing the heat press are not particularly limited. In order to adjust the sheet member S to a desired hardness, the temperature for performing the heat press and the like can be appropriately adjusted depending on the type of fibers constituting the sheet member S and the like.

[0057] For example, the fused portion 60 can be formed by heating the sheet member S to a temperature or higher at which the fibers made of a biodegradable material forming the main body melt. Alternatively, the fused portion 60 can be formed by heating the sheet member S to a temperature or higher at the melting point of the fibers. The melting point of PGA is about 218°C, and the melting point of PLGA is about 205°C to 215°C. "Above the temperature at which the fibers melt" refers to a temperature below the melting point of the fibers and above the temperature at which the fibers begin to fuse together. The temperature above the temperature at which the fibers melt is, for example, 150°C to 200°C.

[0058] The pressure of the heat press is, for example, 1 MPa or more, and the time of the heat press is, for example, 20 to 30 minutes.

[0059] The fused portion 60 may be formed by fusing the yarns between the multifilaments together, or may be formed by fusing bundles of multifilaments together. However, it is expected that fusing bundles of multifilaments together will result in higher rigidity.

[0060] As shown in FIG. 12, when the heat pressing (S2) is completed, a plurality of through holes 11 are formed on the first surface 10a and the second surface 10b of the sheet member S after the fused portion 60 is formed (S3).

[0061] As shown in FIG. 14, when forming the through hole 11, a laser is irradiated from a laser device 440 to the sheet member S. The through hole 11 formed by the laser irradiation has an inner surface 11c formed along the thickness direction X of the main body 10. Another fused portion 70 in which fibers are fused to each other in the thickness direction X is formed in at least a part of the inner surface 11c by heat from the laser irradiation. Note that the other fused portion 70 may have a cross-sectional portion in which the inner surface 11c is a cut surface of the fibers by heat from the laser irradiation. That is, the through hole 11 may be formed by cutting the fibers by the laser irradiation. In this case, the inner surface 11c is a cross-sectional portion in which the fibers are cut.

[0062] By changing the diameter of the irradiated laser, the movement pitch, etc., the diameter and pitch of the through holes 11 and the hardness of the sheet member S can be adjusted.

[0063] The sheet member S can be formed by stacking a plurality of sheet materials containing fibers.

[0064] The number of sheets of sheet material used to form the sheet member S is not particularly limited, but may be one sheet, or may be two or more sheets, for example, three sheets. The number of sheets of sheet material can be appropriately selected in consideration of the improvement in strength and handleability of the sheet member S obtained by forming the fused portion 60. The sheet materials to be stacked in multiple sheets may each have a different shape pattern of the through holes 11. For example, a sheet material having through holes 11 arranged in two or more different shape patterns from the shape patterns of the through holes 11 of the main body portion 10 shown in Figures 3 to 6 may be selected and stacked in multiple sheets. However, if the number of sheet materials is too large, it is difficult to fuse the sheets while maintaining the fibers, and it becomes necessary to fuse the sheets at a higher temperature. In this case, the main body portion 10 becomes a film without being able to maintain the shape of the fibers, making it difficult for biological components to enter. For this reason, the upper limit of the number of sheet materials is determined from the viewpoint of being able to exert the desired function as the medical sheet 100.

[0065] The sheet member S can be formed by stacking multiple sheets of sheet material containing fibers, needle punching them, and entangling the fibers of the sheet material with each other before needle punching. Needle punching can promote entanglement of the fibers of the multiple sheet members S. Needle punching can also loosen multifilaments, which are a collection of multiple fibers, and promote entanglement of the fibers. Promoting entanglement of the fibers makes it easier to form the fused portion 60 when the fibers are fused together, and the rigidity of the medical sheet 100 can be increased. Needle punching is performed in the step (S1) of preparing the sheet member S, which is prior to the step (S2) of forming the fused portion 60.

[0066] As described above, the medical sheet 100 according to this embodiment has a sheet-like main body 10 having a first surface 10a and a second surface 10b containing fibers made of a biodegradable material, and a plurality of through holes 11 having openings 11a, 11b on the first surface 10a and the second surface 10b of the main body 10. The medical sheet 100 further has fused parts 60 formed between the openings 11a, 11a, and between the openings 11b, 11b of the plurality of through holes 11, in which the fibers are fused to each other in the planar direction YZ. With this configuration, the rigidity of the main body 10 can be increased by the fused parts 60, and the occurrence of twisting or shifting of the medical sheet 100 can be prevented or suppressed. In addition, the through holes 11 can be easily formed, and the shape of the through holes 11 can be easily maintained. By increasing the rigidity of the main body 10, the medical sheet 100 can be easily punched out by a stapler such as the medical instrument 200, and fraying of the fibers can be made less likely to occur (improved punchability).

[0067] The fused portion 60 is formed around the openings 11a, 11b of at least some of the through holes 11 among the plurality of through holes 11. By configuring in this manner, it becomes easier to form the through holes 11, and the shape of the through holes 11 can be more easily maintained.

[0068] The through-holes 11 have an inner surface 11c formed along the thickness direction X of the main body portion 10. The medical sheet 100 further has another fused portion 70 formed on at least a part of the inner surface 11c and formed by fusing fibers together in the thickness direction X. With this configuration, the rigidity of the main body portion 10 can be further increased by the other fused portion 70, and twisting or shifting of the medical sheet 100 can be further prevented or suppressed.

[0069] The main body 10 contains a thermoplastic material on the first surface 10a and the second surface 10b. By configuring in this manner, it is possible to easily form the fused portion 60 in which the fibers are fused to each other in the planar direction YZ.

[0070] The method for manufacturing the medical sheet 100 involves first applying heat while applying pressure to the first surface 10a and the second surface 10b of a sheet member S having a first surface 10a and a second surface 10b containing fibers made of a biodegradable material, thereby forming a fused portion 60 in which the fibers are fused to each other in the planar direction YZ in a portion of at least one of the first surface 10a and the second surface 10b. Then, a plurality of through holes 11 are formed in the first surface 10a and the second surface 10b of the sheet member S after the fused portion 60 has been formed. By configuring in this manner, a medical sheet 100 can be manufactured in which the main body portion 10 has high rigidity, twisting or shifting can be prevented or suppressed, punching properties can be improved, and through holes 11 can be easily formed.

[0071] The sheet member S is heated to a temperature equal to or higher than the temperature at which the fibers melt, to form the fused portion 60. With this configuration, the fused portion 60 can be formed by melting the fibers.

[0072] The sheet member S is heated to a temperature equal to or higher than the melting point of the fibers to form the fused portion 60. With this configuration, the fused portion 60 can be formed by melting the fibers.

[0073] The sheet member S is formed by stacking a plurality of sheet materials containing fibers. By configuring it in this manner, a medical sheet 100 that satisfies the strength and handling properties required of the sheet member S can be easily manufactured.

[0074] The sheet member S is formed by stacking multiple sheets of sheet material containing fibers, needle punching them, and entangling the fibers of the sheet material with each other before needle punching. By configuring it in this way, it is expected that the entanglement between the fibers will be promoted and the rigidity of the main body portion 10 will be increased when the fibers are fused together. In addition, the medical sheet 100 that meets the strength and handleability required of the sheet member S can be easily manufactured.

[0075] <Modification> FIG. 15 is a cross-sectional view showing a main portion of a medical sheet 100 according to a modified example.

[0076] Although the embodiment in which the through hole 11 is formed by laser irradiation has been described, the method of forming the through hole 11 is not limited to the laser irradiation. For example, the through hole 11 can be formed by dropping an organic solvent to melt the fibers, punching with a punch, pulling to widen the hole, piercing with a needle, etc. Since the rigidity of the main body 10 is increased by the fused portion 60, it becomes easier to form the through hole 11 and to easily maintain the shape of the through hole 11 regardless of the formation method.

[0077] Among these methods, when dropping an organic solvent and punching with a punch, the through hole 11 is formed by cutting the fibers. As shown in Fig. 15, the through hole 11 has an inner surface 11d formed along the thickness direction X of the main body 10, and the inner surface 11d has a cross-sectional portion 11e that is a cut surface of the fibers.

[0078] The through-holes 11 are formed in the sheet member S after the fused portion 60 has been formed. Therefore, the fused portion 60 is formed and exists in the cross-sectional portion 11e.

[0079] As described above, the through hole 11 has the inner surface 11d formed along the thickness direction X of the main body 10, and the inner surface 11d has a cross-sectional portion 11e which is a cut surface of the fibers. With this configuration, even when the fibers are cut to form the through hole 11, the rigidity of the main body 10 is increased by the fused portion 60, so that the through hole 11 is easily formed and the shape of the through hole 11 can be easily maintained.

[0080] The fused portion 60 is formed on the cross-sectional portion 11e. With this configuration, the fused portion 60 is present around the openings 11a and 11b of the through hole 11, which makes it easier to form the through hole 11 and makes it easier to maintain the shape of the through hole 11.

[0081] The present invention is not limited to the above-described embodiment and modified examples, and various modifications are possible within the scope of the claims.

[0082] For example, when forming the through-holes 11 by piercing a needle, the needle can be heated after penetrating the sheet member S, or a pre-heated needle can be inserted into the sheet member S. In this case, the through-holes 11 also have an inner surface 11c formed along the thickness direction X of the main body portion 10. The medical sheet 100 further has another fused portion 70 formed on at least a part of the inner surface 11c and formed by fusing fibers together in the thickness direction X. For this reason, the rigidity of the main body portion 10 can be further increased by the other fused portion 70, and the occurrence of twisting or shifting of the medical sheet 100 can be further prevented or suppressed. [Explanation of symbols]

[0083] 10 Main body, 10a 1st face, 10b. Second facet, 11 through hole, 11a, 11b opening, 11c inner surface, 11d inner surface, 11e cross section, 20 Reinforcement part, 30 Fixed part, 40 holes, 60 fusion part, 70 Other fused parts, 100, 100a medical sheets, 410 heating plate, 420 Pressurizing member, 430 Support stand; 440 Laser equipment, S sheet material, X thickness direction, YZ plane direction.

Claims

1. A sheet-like main body having a first surface and a second surface including fibers made of a biodegradable material; a plurality of through holes having openings on the first surface and the second surface of the body portion; and fused portions formed between the openings of the plurality of through holes, the fibers being fused together in a planar direction.

2. The medical sheet according to claim 1 , wherein the fused portion is formed around the opening of at least some of the plurality of through holes.

3. The through hole has an inner surface formed along a thickness direction of the main body, 2. The medical sheet according to claim 1, further comprising another fused portion formed on at least a part of the inner surface, the other fused portion being formed by fusion of the fibers together in the thickness direction.

4. The through hole has an inner surface formed along a thickness direction of the main body, The medical sheet according to claim 1 , wherein the inner surface has a cross-sectional portion which is a cut surface of the fibers.

5. The medical sheet according to claim 4 , wherein the fused portion is formed on the cross-sectional portion.

6. 2. The medical sheet according to claim 1, wherein the main body portion comprises a thermoplastic material on the first surface and the second surface.

7. applying heat while applying pressure to the first surface and the second surface of a sheet member having a first surface and a second surface containing fibers made of a biodegradable material, thereby forming a fused portion in which the fibers are fused to each other in a planar direction in a part of at least one of the first surface and the second surface; A method for manufacturing a medical sheet, comprising forming a plurality of through holes on the first surface and the second surface of the sheet member after the fused portion has been formed.

8. The method for producing a medical sheet according to claim 7, wherein the fused portions are formed by heating the sheet member to a temperature equal to or higher than the temperature at which the fibers melt.

9. The method for producing a medical sheet according to claim 7 , wherein the fused portions are formed by heating the sheet member to a temperature equal to or higher than the melting point of the fibers.

10. The method for producing a medical sheet according to claim 7, wherein the sheet member is formed by stacking a plurality of sheet materials containing the fibers.

11. The method for manufacturing a medical sheet according to claim 7, wherein the sheet member is formed by stacking multiple sheets of sheet material containing the fibers, needle-punching the stacked sheets, and entangling the fibers of the sheet material with each other before the needle-punching.

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