Tissue reinforcement material and method for producing tissue reinforcement material

Abstract

This invention enhances rigidity of a body part of a tissue reinforcement material, and prevents or minimizes twisting thereof when placed in a biological organ.　The invention includes a sheet-shaped body part 10 containing fibers composed of a biodegradable material. The body part has multiple through-holes 11, wherein there is a fusion part 50 that is formed due to the fibers being gathered and fused around the through-holes.

Description

Tissue reinforcement material and method for manufacturing the same

[0001] The present invention relates to a tissue reinforcement material and a method for manufacturing the tissue reinforcement material.

[0002] In the medical field, surgical procedures for joining biological organs (e.g., anastomosis of the digestive tract) are known. When such procedures are performed, it is known that the absence of delayed healing at the junction 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 anastomosis of biological organs, including a method using biodegradable sutures and a method using a mechanical anastomosis device that performs anastomosis with a stapler. In particular, when performing anastomosis using a mechanical anastomosis device, the joining strength between biological organs at the joint can be increased compared to methods using sutures, thereby reducing the risk of anastomosis failure.

[0004] Special Publication No. 2008-516678

[0005] The anastomosis device of Patent Document 1 promotes healing of the anastomosis site by sandwiching a sheet-like member (hereinafter referred to as a tissue reinforcement material) such as a support structure to prevent leakage or tearing at the anastomosis site. Such tissue reinforcement materials are typically relatively thin and soft. The inventors have been actively studying ways to increase the rigidity of the main body constituting the tissue reinforcement material, prevent twisting (a state in which the tissue reinforcement material is bent or folded and not flat) when placed in a biological organ, and prevent fraying (a state in which the fibers are loose at the cut ends of the fibers) of the tissue reinforcement material when performing an anastomosis using a mechanical anastomosis device.

[0006] Therefore, an object of the present invention is to increase the rigidity of the main body that constitutes the tissue reinforcement material, and to prevent or suppress twisting and fraying when placed in a living organ.

[0007] The present invention is achieved by any one of the following means (1) to (17).

[0008] (1) A tissue reinforcement material having a sheet-like main body portion containing fibers made of a biodegradable material, wherein the main body portion has a plurality of through holes formed therein, the initial elongation rate of the main body portion in a first direction is 22% or less, and the initial elongation rate of the main body portion in a second direction intersecting the first direction does not exceed 71%.

[0009] (2) A tissue reinforcement material as described in (1) above, in which the initial elongation rate in the first direction is 0.3% or more and 2.4% or less.

[0010] (3) A tissue reinforcement material according to (1) or (2) above, wherein the initial elongation rate in the second direction is 0.5% or more and 6.0% or less.

[0011] (4) A sheet-like main body portion including fibers made of a biodegradable material, the main body portion having a plurality of through holes formed therein, and an initial Young's modulus in a first direction of the main body portion being 0.4 N / mm ２ or more, and the initial Young's modulus of the main body portion in a second direction intersecting the first direction is 0.2 N / mm ２ Tissue reinforcement materials that do not contain:

[0012] (5) The initial Young's modulus in the first direction is 2 N / mm ２ 20N / mm or more ２ The tissue reinforcement material according to (4) above, which is as follows:

[0013] (6) The initial Young's modulus in the second direction is 1 N / mm ２ More than 17N / mm ２ A tissue reinforcement material according to (4) or (5) above, which is:

[0014] (7) A tissue reinforcement material described in any of (4) to (6) above, wherein when the initial Young's modulus ratio of the second direction of the main body portion to the first direction is a%, and the initial Young's modulus ratio of the first direction of the main body portion to the second direction is b%, b = 10000 / a, 50 < a ≦ 150.

[0015] (8) A tissue reinforcement material according to any one of (1) to (7) above, wherein the knitted fabric of the main body portion is warp knitted or weft knitted.

[0016] (9) A tissue reinforcement material according to any one of (1) to (8) above, wherein the main body portion is needle-punched.

[0017] (10) A tissue reinforcement material described in any of (1) to (9) above, wherein the breaking elongation when pulled in the first direction is less than 58%, and the breaking elongation when pulled in the second direction does not exceed 74%.

[0018] (11) A tissue reinforcement material according to any one of (1) to (10) above, wherein the main body is used by being sandwiched between an anastomotic site of a living organ.

[0019] (12) A tissue reinforcement material according to any one of (1) to (11) above, wherein the main body portion has a fused portion formed by the fibers gathering and fusing around the through hole.

[0020] (13) A tissue reinforcement material as described in (12) above, wherein the through hole is formed along the thickness direction of the main body portion, and the fused portion is formed along the thickness direction.

[0021] (14) A tissue reinforcement material described in (12) or (13) above, wherein the fused portion comprises a portion where the fibers are completely fused and a portion where the fibers are fused around the fibers while maintaining their shape.

[0022] (15) The main body portion comprises a proximal portion located near the through hole in the surface direction of the main body portion, and a distal portion that is farther away from the through hole in the surface direction than the proximal portion, and a tissue reinforcement material described in any of (12) to (14) above, in which the fibers are present at a higher density in the proximal portion than in the distal portion.

[0023] (16) The tissue reinforcement material according to (15) above, wherein the fused portion is formed in the vicinity.

[0024] (17) A method for manufacturing a tissue reinforcement material described in any one of (12) to (16) above, comprising: penetrating a needle into the main body portion to form the through hole; heating the needle while the needle is still penetrating the main body portion; or penetrating the heated needle into the main body portion to form the fused portion in the fibers surrounding the through hole.

[0025] According to the tissue reinforcement materials described in (1) to (16) above and the method for manufacturing the tissue reinforcement material described in (17) above, the rigidity of the main body portion constituting the medical sheet can be increased, and twisting and fraying when placed in a biological organ can be prevented or suppressed.

[0026] 1 is a perspective view showing a tissue reinforcing material according to an embodiment. FIG. 1 is an enlarged cross-sectional view showing through holes in a main body portion of the tissue reinforcing material. FIG. 2 is a diagram showing the shape pattern of the through holes in the tissue reinforcing material. FIG. 3 is a diagram showing the shape pattern of a modified example of the through holes in the tissue reinforcing material. FIG. 4 is a diagram showing the shape pattern of a modified example of the through holes in the tissue reinforcing material. FIG. 5 is a perspective view showing a tissue reinforcing material according to a modified example of FIG. 1. FIG. 6 is an exploded perspective view showing a portion (tip portion) of a medical device used when anastomosis of biological organs using a tissue reinforcing material. FIG. 7 is an enlarged image showing the fused portion of the tissue reinforcing material. FIG. 8 is an enlarged image showing the fused portion of the tissue reinforcing material. FIG. 9 is a flowchart showing a method for manufacturing a tissue reinforcing material according to an embodiment. FIG. 10 is a diagram showing a needle member used in a method for manufacturing a tissue reinforcing material according to a first embodiment. FIG. 11 is a schematic diagram showing the formation of through holes in a sheet member with a needle member. FIG. 12 is a diagram showing a needle member used in a method for manufacturing a tissue reinforcing material according to a second embodiment. FIG. 13 is a graph showing the longitudinal breaking strength and breaking elongation of a tissue reinforcing material according to Experiment 1. FIG. 14 is a graph showing the transverse breaking strength and breaking elongation of a tissue reinforcing material according to Experiment 1. 10 is a graph showing the initial Young's modulus of the tissue reinforcement material according to Experiment 2. 11 is a graph showing the initial elongation rate of the tissue reinforcement material according to Experiment 2. 12 is a graph showing the ratio of the initial Young's modulus in the horizontal direction to the vertical direction and the ratio of the initial Young's modulus in the vertical direction to the horizontal direction of the tissue reinforcement material according to Experiment 2.

[0027] <First Embodiment> Hereinafter, embodiments for carrying out the present invention will be described in detail with reference to the drawings. The embodiments shown here are provided as examples to embody the technical idea of ​​the present invention and are not intended to limit the present invention. Furthermore, all other embodiments, examples, and operational techniques that can be conceived by those skilled in the art without departing from the spirit of the present invention are included in the scope and spirit of the present invention, as well as in the scope of the inventions described in the claims and their equivalents.

[0028] Furthermore, for the convenience of illustration and ease of understanding, the drawings attached to this specification may be represented schematically with the scale, aspect ratio, shape, etc. appropriately changed from the actual product, but these are merely examples and do not limit the interpretation of the present invention.

[0029] 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 stipulate any particular order.

[0030] <Tissue Reinforcement Material> FIG. 1 is a perspective view showing a tissue reinforcement material 100 according to an embodiment. FIG. 2 is an enlarged view showing a through-hole 11 of the tissue reinforcement material. The tissue reinforcement material 100 is sandwiched and disposed between two or more biological organs (one to be joined and the other to be joined) to be anastomosed, and is configured in a flat sheet shape with multiple 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 tissue reinforcement material 100 is disposed in direct or indirect contact with the biological organs; the tissue reinforcement material 100 is disposed with a spatial gap formed between the biological organs; or the tissue reinforcement material 100 is disposed in both of these states (e.g., the tissue reinforcement material 100 is disposed in contact with one biological organ and not in contact with the other biological organ). Examples of biological organs include digestive tracts such as the large intestine and the jejunum, and hollow organs such as the pancreatic duct. The tissue reinforcement material 100 is sandwiched between two or more biological organs (one of the to-be-joined portions and the other of the to-be-joined portions) to be anastomosed, thereby enabling reinforcement of the anastomotic portion of the biological organ in a shape suitable for the anastomotic portion of the biological organ until the anastomotic portion of the biological organ heals. As shown in FIG. 1 and other figures, the tissue reinforcement material 100 comprises a main body portion 10, a reinforcing portion 20, a fixing portion 30, a hole portion 40, and a fusion portion 50. Note that the tissue reinforcement material 100 may not comprise the reinforcing portion 20 and the fixing portion 30, but may be comprised of the main body portion 10, the hole portion 40, and the fusion portion 50. Alternatively, the tissue reinforcement material 100 may not comprise the reinforcing portion 20, but may be comprised of the main body portion 10, the fixing portion 30, the hole portion 40, and the fusion portion 50. Note that a Cartesian coordinate system is illustrated in some drawings, and hereinafter, the surface direction of the main body portion 10 will be referred to as the surface direction YZ, and the thickness direction will be referred to as the thickness direction X. Details are provided below.

[0031] <Main Body> The main body 10 is disposed between biological organs to be anastomosed (for example, between two large intestines, or between the pancreatic duct and the jejunum), and is configured in a sheet shape that can follow the movements of the biological organs to be anastomosed. In this way, the main body 10 is used by being sandwiched between the anastomoses of the biological organs.

[0032] The main body 10 is formed, for example, in a circular shape as shown in FIG. 1 , and includes 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 in the main body 10 is preferably 0.1 to 6 mm, more preferably 0.3 to 4 mm, and even more preferably 0.6 to 1.5 mm. The main body 10 can promote healing by the through holes 11. The main body 10 can be configured such that the ratio of the dimension 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 greater and less than 40. Because the main body 10 has a plurality of through holes 11, there are multiple values ​​of the hole diameter D corresponding to each through hole 11. Therefore, in this embodiment, when calculating the above-mentioned ratio, the arithmetic mean value of two or more values ​​of the hole diameter D corresponding to each of the plurality of through holes 11 is used as a 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 combinations of adjacent through holes 11. Therefore, in this embodiment, when calculating the value of the above-mentioned ratio, the arithmetic mean value of two or more values ​​of the pitch P corresponding to each 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 other shapes such as an ellipse, a polygon such as a rectangle, a star, etc. may also be used.

[0033] Fig. 3 is a diagram showing the shape pattern of the through holes 11 in the main body 10, and Figs. 4 to 6 are diagrams showing shape patterns according to modified examples of the through holes 11 in the main body 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, it is also possible to arrange through holes 11 of different sizes at equal intervals as shown in Fig. 4, to arrange through holes of the same size at a 60° staggered pitch (staggered arrangement) as shown in Fig. 5, or to arrange through holes 11 of different sizes randomly as shown in Fig. 6.

[0034] The thickness of the main body portion 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 merely examples, and other dimensions may also be used. When the dimension T, which is the thickness of the main body portion 10, is 0.7 mm or less (particularly when it is 0.45 mm or less), the flexibility of the main body portion 10 can be increased. This allows the main body portion 10 to adhere closely to the biological organ and improve 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 portion 10, is 0.05 mm or less, the strength of the main body portion 10 is insufficient, and the tissue reinforcement material 100 may twist, making it difficult to position it between the biological organs to be anastomosed.

[0035] As shown in the experimental results described below, the initial elongation rate of the main body 10 in the first direction is 22% or less, and the initial elongation rate in the second direction can be configured to not exceed 71%. The initial elongation rate of the main body 10 in the first direction can be configured to be 0.3% or more and 2.4% or less, and the initial elongation rate in the second direction can be configured to be 0.5% or more and 6.0% or less. The initial Young's modulus of the main body 10 in the first direction is 0.4 N / mm ２ or more, and the initial Young's modulus in the second direction is 0.2 N / mm ２ The main body 10 may be configured not to include the following: In addition, the initial Young's modulus in the first direction of the main body 10 is 2 N / mm ２ 20N / mm or more ２ and an initial Young's modulus in the second direction of 1 N / mm ２ More than 17N / mm ２ The main body 10 can be configured as follows: If the initial Young's modulus in the second direction relative to the first direction of the main body 10 is a %, and the initial Young's modulus in the first direction relative to the second direction of the main body 10 is b %, then b can be expressed as b = 10000 / a (50 < a ≦ 150). Furthermore, as shown in the experimental results described below, the main body 10 can be configured so that the breaking elongation when tensile in the first (vertical) direction is less than 58%, and the breaking elongation when tensile in the second (horizontal) direction, which is intersecting with the first direction and preferably perpendicular to the first direction, does not exceed 74%.

[0036] The starting material for the main body 10 can be a sheet-like molded product formed by knitting or weaving a multifilament of multiple fibers (e.g., yarn) made of a biodegradable material. That is, the main body 10 can be formed from a biodegradable sheet made of biodegradable fibers. There are no particular restrictions on the material that can be used for the main body 10, and examples include biodegradable resins that induce a biological reaction.

[0037] Examples of biodegradable resins include (1) polymers selected from the group consisting of aliphatic polyesters, polyesters, polyanhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphate esters, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and cellulose; and (2) copolymers composed of one or more monomers constituting the above (1).

[0038] 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, polyphosphate esters, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and cellulose, as well as copolymers composed of one or more monomers that constitute 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).

[0039] The main body 10 is produced by converting a sheet of processed biodegradable fibers into a nonwoven fabric, followed by a process involving heating to form through-holes 11. The main body 10 thus produced induces a biological reaction due to the constituent materials, such as biodegradable resin, that make up the main body 10. This action of the main body 10 induces the expression of biological components such as fibrin. The biological components thus induced 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 sandwiching the main body 10 of the tissue reinforcement material 100 between biological organs to be joined (e.g., between two anastomosed intestinal tracts of the large intestine, between two cut surfaces of anastomosed intestinal tracts of the large intestine, or between the pancreatic parenchyma and the jejunum), healing is promoted by the above-mentioned mechanism. The main body 10 can also be formed by warp knitting or weft knitting and can be needle-punched.

[0040] <Reinforcing portion> The reinforcing portion 20 is provided to prevent twisting, shifting, breakage, falling off, etc. of the tissue reinforcing material 100 when, for example, the tissue reinforcing material 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 shape of the main body portion 10.

[0041] In this embodiment, the reinforcing portion 20 is configured to have higher rigidity than the main body portion 10. In this embodiment, the reinforcing portion 20 is configured in a shape that does not include through holes 11 in the main body portion 10. The reinforcing portion 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), or PCL (polycaprolactone). However, the reinforcing portion 20 may also include a non-bioabsorbable material.

[0042] The reinforcement portion 20 may be provided around the entire circumference of the main body portion 10 on the outward side in the planar direction YZ, or may be provided at one or more locations within the entire circumference. Here, the outward direction refers to the direction away from the center Pt (a virtual point) of the tissue reinforcement material 100 in the planar direction YZ. The direction approaching the center Pt of the tissue reinforcement material 100 in the planar direction YZ is the inward direction. The reinforcement portion 20 may be bonded to the main body portion 10 by adhesive or thermal fusion, or sewn with thread. The main body portion 10 and the reinforcement portion 20 may be made of the same material, with the reinforcement portion 20 being more rigid than the main body portion 10. In this case, to eliminate the through-hole 11, the through-hole 11 of the main body portion 10 may be crushed in the thickness direction X (axial direction) so that the thickness of the reinforcement portion 20 in the thickness direction X (axial direction) is smaller than the thickness of the main body portion 10 in the thickness direction X (axial direction). The reinforcement portion 20 may not be provided. Fig. 7 is a perspective view showing a tissue reinforcing material 100a according to a modified example that does not include a reinforcing portion 20. As shown in Fig. 7, the tissue reinforcing material 100 may be composed of a main body portion 10, a fixing portion 30, a hole portion 40, and a fused portion 50. When the reinforcing portion 20 is not provided, the outer peripheral edge of the tissue reinforcing material 100 is composed of the main body portion 10 having through holes 11 that continue outward from the main body portion 10.

[0043] 8 is an exploded perspective view showing the distal end of a medical instrument 200 used when placing the tissue reinforcement material 100 in a biological organ. The medical instrument 200 includes a first instrument 210 and a second instrument 250. The first instrument 210 and the second instrument 250 can be engaged with each other by engaging a positioning portion 220 of the first instrument 210 with a shaft 260 of the second instrument 250. The medical instrument 200 may also be called a stapler, the first instrument 210 may also be called a trocar, and the second instrument 250 may also be called an anvil. The first and second to-be-joined portions, and the main body portion 10 can be sandwiched between the first and second instruments 210 and 250. The reinforcing portion 20 and a portion of the outward side of the main body portion 10 (the main body portion 10 near the inner circumference of the reinforcing portion 20) are deformed by being clamped together with the clamping portion 270 of the second instrument 250 facing the release portion 240 when the staple released from the release portion 240 of the first instrument 210 of the medical instrument 200 is released, thereby joining and integrating the first and second joined portions.

[0044] <Fixing portion 30> The fixing portion 30 is provided to prevent or inhibit displacement of the tissue reinforcement material 100 and to prevent it from falling off, for example, when the tissue reinforcement material 100 is placed between the first and second bonded portions. The fixing portion 30 is formed along the inner peripheral edge of the hollow circular shape of the main body portion 10. That is, the fixing portion 30 is formed to surround the center Pt (an imaginary point) of the tissue reinforcement material 100 in the planar direction YZ. Therefore, the tissue reinforcement material 100 is composed of a circular reinforcing portion 20 formed to surround the center Pt of the tissue reinforcement material 100, the main body portion 10 formed to surround the outer periphery of the reinforcing portion 20, and the reinforcing portion 20 formed to surround the outer periphery of the main body portion 10. The tissue reinforcement material 100 is arranged in the following order from the center Pt outward in the planar direction YZ: the fixing portion 30, the main body portion 10, and the reinforcing portion 20.

[0045] 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.

[0046] The fixing portion 30 may be provided around the entire circumference on the inner side of the main body portion 10 in the planar direction YZ, or may be provided at one or more locations within the entire circumference. The fixing portion 30 is configured coaxially with the inner edge, but its center may be offset from the main body portion 10 as long as it does not enter the fusion region. The fixing portion 30 and the inner side of the main body portion 10 are punched out by the punching portion 230 of the first device 210 of the medical device 200 during the procedure, and are separated from the outer side of the main body portion 10 and the reinforcement portion 20. The fixing portion 30 does not have to be provided. When the fixing portion 30 is not provided, the inner peripheral edge of the tissue reinforcement material 100 is formed by the main body portion 10 having a through-hole 11 that continues inward from the main body portion 10.

[0047] <Hole> The hole 40 is spaced from the outer periphery of the main body 10 in the planar direction YZ of the main body 10, and is formed by the fixing part 30 in this embodiment. The hole 40 is configured to be able to insert the shaft 260 of the second instrument 250 of the medical instrument 200. In this embodiment, the hole 40 has a hole diameter larger than the hole diameter D of each through-hole 11, and is therefore configured to be able to insert the shaft 260. The shaft 260 of the second instrument 250 is configured to be able to accommodate the positioning part 220 of the first instrument 210.

[0048] In this embodiment, the hole 40 is configured to have a substantially circular shape when viewed from the thickness direction X. However, the specific shape of the hole is not limited to a circular shape as long as the main body 10 can promote healing of biological tissue. 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-shaped or other notch shape.

[0049] 9 to 11 are images showing a part of the fused portion 50. The fused portion 50 is configured as a region where fibers gather and are fused around the through-hole 11. The through-hole 11 of the main body portion 10 is formed along the thickness direction X of the main body portion 10. The fused portion 50 is configured to be formed along the thickness direction X.

[0050] The fused portion 50 shown in FIG. 10 includes a first portion 51 in which the fibers are completely fused, as shown in FIG. 9 , and a second portion 52 in which the peripheries of the fibers are fused while maintaining the fiber shape. Here, "completely fused" refers to a state in which the fibers are fused together (i.e., fibers that are originally separate are integrated to an extent that they cannot be distinguished even when viewed under a microscope). "Fused around the peripheries of the fibers while maintaining the fiber shape" refers to a state in which the fibers are not fused together (i.e., fibers that are originally separate are integrated to an extent that they cannot be distinguished even when viewed under a microscope), but the peripheries of the fibers are fused together (i.e., fibers that are originally separate are integrated to an extent that they can be distinguished even when viewed under a microscope). As shown in FIG. 11 , the main body 10 includes a proximal portion 12 located near the through hole 11 relative to the fused portion 50, and a distal portion 13 that is farther from the through hole 11 in the planar direction YZ than the proximal portion 12. The proximal portion 12 includes the edge of the through hole 11. The distal portion 13 includes the periphery of the center of the distance (pitch P) between two through holes 11. Here, the range from the edge of one through hole 11 in the main body portion 10 to less than 50% of the length between adjacent through holes 11 can be the proximal portion 12, and the remaining range can be the distal portion 13. The proximal portion 12 is configured so that fibers are present at a higher density than the distal portion 13.

[0051] As described below, the fused portion 50 is formed in the proximal portion 12 and the distal portion 13 on one side (first surface) in the thickness direction X, and is formed only in the proximal portion 12 on the other side (second surface opposite the first surface). The fused portion 50 can be formed so that at least a portion of the multifilament fibers (yarns) are fused together. However, the fused portion 50 may also be formed so that at least a portion of the multifilament fibers (yarns) are fused together. The size of the fused portion 50 is not particularly limited, but can be, for example, 0.015 mm to 0.7 mm. The ratio of the unmelted portion of the fused portion 50 to the total area of ​​the main body portion 10 can be 3% or more and 100% or less. Furthermore, the occupancy rate of the fused portion 50 relative to the main body portion 10 when viewed in a plan view (viewed from the thickness direction X) can be 0.002% or more.

[0052] <Method of forming fused portion> Next, a method of forming the fused portion 50 in the tissue reinforcement material 100 will be described. Fig. 12 is a flowchart showing a method of forming the tissue reinforcement material 100 according to an embodiment. Fig. 13 is a diagram showing a needle member 320 used in the method of forming the fused portion 50 according to the first embodiment. Fig. 14 is a diagram showing the formation of through holes 11 in a sheet member S used when forming the fused portion 50 in the tissue reinforcement material 100. The sheet member S is a sheet-like member containing fibers made of a biodegradable material and does not have through holes 11 formed therein.

[0053] One example of a method for forming the fused portion 50 uses a forming member 300 having a base 310 with a circular flat base and numerous thermally conductive needle members 320 attached to the tip thereof, as shown in FIG. 13 . The base 310 of the forming member 300 incorporates a heatable component, such as by generating ultrasound. By generating heat in the base 310, the heat can be conducted to the multiple needle members 320. In this embodiment, the forming member 300 is preheated. The needle members 320 are heated to a temperature above the melting point of the fibers made of the biodegradable material forming the main body 10 or above the melting point of the fibers (for PGA, approximately 200°C, 218°C, or 218°C or higher; for PLGA, approximately 200°C, 215°C, or 215°C or higher). The needle members 320 are then inserted through the sheet member S of the tissue reinforcement material 10 before processing (S1), and the base 310 is brought into contact with the sheet member S, followed by pressing.

[0054] 14 , the area around the edge of the through hole 11 (corresponding to the area 12 near the main body 10) in the sheet member S is heated and melted, and the fibers around the through hole 11 are melted to become one unit, forming a fused portion 50 (S2). In this embodiment, the needle member 320 has a shape in which a cylindrical portion and a conical portion having the same diameter are stacked on top of each other in the base 310. However, the shape of the needle member 320 is not particularly limited as long as it can form the through hole 11 with the desired hole diameter D. For example, the needle member 320 may be conical, pyramidal, cylindrical, tapered, or the like. Furthermore, the needle member 320 may have a diameter that is the same as or equivalent to the hole diameter D. In this embodiment, the diameter of the cylindrical portion of the needle member 320 and the diameter of the base of the conical portion are the same as the hole diameter D, and the cylindrical portion penetrates and perforates the sheet member S. However, as long as the through-hole 11 can be formed with the desired hole diameter D, the cylindrical portion does not need to penetrate the sheet member S.

[0055] 14 indicates a region of the sheet member S with which the needle members 320 come into direct contact, and region 15 indicates a region (first surface) with which the base 310 comes into direct contact. Regions 14 and 15 where the base 310 and the needle members 320 come into direct contact experience a greater amount of thermal load than regions (second surface) where the base 310 and the needle members 320 do not come into direct contact. Therefore, when viewed from the thickness direction X, one side of the sheet member S (front side, regions 14 and 15 where the base 310 and the needle members 320 come into direct contact, first surface) has more melted fibers and is more rigid than the other side (back side, regions where the base 310 and the needle members 320 do not come into direct contact, second surface).

[0056] 14 , the surface (region 15) of the sheet member S that contacts the base 310 is an uneven plane due to the fibers, and therefore there are portions that do not directly contact the base 310. The through-holes 11 are formed by avoiding the fibers of the sheet member S at the edge (corresponding to the region 12 near the main body 10) that is perforated by the needle members 320. As a result, the region 12 near the through-holes 11 has a higher fiber density than the distal region 13. In other words, the density of the through-holes 11 is higher than the density of the surface of the sheet member S. The region 15, which is heated by contact with the base 310 and where the fibers are partially melted and fused, is formed on only one side of the main body 10, and therefore the main body 10 can be provided with a certain degree of both flexibility and rigidity. Note that, on one side (front side, regions 14 and 15 where the base 310 and the needle member 320 are in direct contact, first surface) when viewed from the thickness direction X where the base 310 is in direct contact, the fused portion 50 is formed in the proximal portion 12 and the distal portion 13. On the other side (back side, region where the base 310 and the needle member 320 are not in direct contact, second surface) where the base 310 and the needle member 320 are not in direct contact, the fused portion 50 is formed only in the proximal portion 12. Regions away from the vicinity of the needle member 320 (corresponding to the distal portion 13 of the main body 10) are not completely melted by heat, but are slightly melted by heat conduction, forming the fused portion 50 in a state where the fibers are not completely melted. The fused portion 50 may be formed by fusing threads between multifilaments or by fusing bundled multifilaments together. However, fusion of bundled multifilaments together is expected to result in higher rigidity.

[0057] The number of sheet members S used to form the main body 10 is not particularly limited, and may be one or two or more, but is preferably two to eight, and four is more preferred because it provides a good balance between heating conditions and strength. By forming the through holes 11 while applying heat, the periphery of the edges is melted, making it easier to maintain the shape of the through holes 11.

[0058] After applying heat to the needle members 320, the sheet member S is cooled (S3), and the needle members 320 are removed from the sheet member S (S4). The cooling method is not particularly limited, and natural cooling or forced cooling using air or the like may be used. Cooling may be performed while the needle members 320 remain inserted, or after the needle members 320 are removed from the sheet member S. When the heated needle members 320 are punctured and processed as described above, and then the needle members 320 are separated from the sheet member S and cooled, protrusions may be formed around the edges. These protrusions facilitate positioning. Furthermore, the hardness of the sheet member S and the size and distribution of the through holes can be adjusted by changing the temperature, time, and pressure of the heat press, as well as the diameter and pitch of the needle members.

[0059] As described above, the tissue reinforcement material 100 according to this embodiment has a sheet-like main body portion 10 containing fibers made of a biodegradable material. The main body portion 10 has a plurality of through holes 11 formed therein, and is configured such that the initial elongation rate of the main body portion 10 in a first direction is 22% or less and the initial elongation rate of the main body portion in a second direction intersecting the first direction does not exceed 71%. This configuration makes it easier to maintain the shape of the through holes 11 in the main body portion 10. Furthermore, configuring the fused portion 50 as described above increases the rigidity of the main body portion 10, thereby preventing or suppressing twisting or slippage of the tissue reinforcement material 100. Furthermore, increasing the rigidity of the main body portion 10 prevents or suppresses fraying when the tissue reinforcement material 100 is punched with a stapler such as the medical device 200, making punching easier.

[0060] The initial elongation rate in the first direction is set to be 0.3% or more and 2.4% or less. This configuration can prevent or suppress twisting or shifting of the tissue reinforcement material 100. Furthermore, by increasing the rigidity of the main body 10, fraying can be prevented or suppressed when the tissue reinforcement material 100 is punched out with a stapler such as the medical device 200, making punching easier.

[0061] Furthermore, the initial elongation rate in the second direction is set to be 0.5% or more and 6.0% or less. By configuring in this manner, it is possible to prevent or suppress the occurrence of twisting or shifting of the tissue reinforcement material 100, and it is possible to prevent or suppress fraying when punched out with a stapler, making punching easier.

[0062] The tissue reinforcement material 100 has a sheet-like main body 10 containing fibers made of a biodegradable material, and the main body 10 has a plurality of through holes 11. The initial Young's modulus of the main body 10 in the first direction is 0.4 N / mm ２ or more, and the initial Young's modulus of the main body in a second direction intersecting the first direction is 0.2 N / mm ２ The main body 10 is configured so as not to include the following. This configuration can prevent or suppress twisting or shifting of the tissue reinforcement material 100. Furthermore, by increasing the rigidity of the main body 10, fraying can be prevented or suppressed when the tissue reinforcement material 100 is punched out with a stapler such as the medical device 200, making punching easier.

[0063] The initial Young's modulus in the first direction is 2 N / mm ２ 20N / mm or more ２ This configuration prevents or suppresses twisting or shifting of the tissue reinforcement material 100, and prevents or suppresses fraying when punched out with a stapler, making punching easier.

[0064] The initial Young's modulus in the second direction is 1 N / mm ２ 17 / mm or more ２ This configuration prevents or suppresses twisting or shifting of the tissue reinforcement material 100, and prevents or suppresses fraying when punched out with a stapler, making punching easier.

[0065] Furthermore, if the initial Young's modulus in the second direction relative to the first direction of the main body 10 is a %, and the initial Young's modulus in the first direction relative to the second direction of the main body 10 is b %, then b = 10000 / a when 50 < a ≦ 150. This makes it possible to calculate the value of one of a and b from the other.

[0066] Furthermore, the knitted fabric of the main body portion 10 is constructed as a warp knit or weft knit. This construction can prevent or suppress twisting or shifting of the tissue reinforcement material 100. Furthermore, by increasing the rigidity of the main body portion 10, fraying can be prevented or suppressed when the tissue reinforcement material 100 is punched out with a stapler such as the medical device 200, making punching easier.

[0067] Furthermore, the main body 10 is configured to be needle-punched. This configuration can prevent or suppress twisting or shifting of the tissue reinforcement material 100. Furthermore, by increasing the rigidity of the main body 10, fraying can be prevented or suppressed when the tissue reinforcement material 100 is punched out with a stapler such as the medical device 200, making punching easier.

[0068] Furthermore, the breaking elongation when pulled in the first direction is less than 58%, and the breaking elongation when pulled in the second direction does not exceed 74%. This configuration can prevent or suppress twisting or shifting of the tissue reinforcement material 100. Furthermore, by increasing the rigidity of the main body 10, fraying can be prevented or suppressed when the tissue reinforcement material 100 is punched out with a stapler such as the medical device 200, making punching easier.

[0069] The main body 10 is configured to be used by being sandwiched between the anastomotic sites of living organs, thereby promoting the healing of separated living organs and contributing to the anastomosis of the relevant sites.

[0070] The main body 10 also includes a fused portion 50 formed by gathering and fusing fibers around the through-hole. This configuration can prevent or suppress twisting or shifting of the tissue reinforcement material 100. Furthermore, by increasing the rigidity of the main body 10, fraying can be prevented or suppressed when the tissue reinforcement material 100 is punched out with a stapler such as the medical device 200, making punching easier.

[0071] Furthermore, the main body 10 is formed along the thickness direction of the main body 10, and the fused portion 50 is formed along the thickness direction. This configuration can contribute to increasing the rigidity of the main body 10 and preventing or suppressing twisting of the tissue reinforcement material 100.

[0072] The fused portion 50 includes a first portion 51 where the fibers are completely fused and a second portion 52 where the fibers are fused around their peripheries while maintaining their shape. The presence of the first portion 51 as well as the second portion 52 in the fused portion 50 allows biological components to easily penetrate into gaps between the fibers, making it easier to achieve a healing effect.

[0073] The main body 10 also includes a proximal portion 12 located near the through hole 11 in the planar direction of the main body 10, and a distal portion 13 that is farther away from the through hole 11 in the planar direction than the proximal portion 12. The proximal portion 12 is configured so that fibers exist at a higher density than the distal portion 13. This configuration makes it easier to improve the strength of the main body 10, thereby making it easier to maintain the shape of the through hole 11.

[0074] The fused portion 50 is formed in the proximal portion 12 and the distal portion 13 at a region 15 (first surface) that is in direct contact with the base portion 310 and the needle member 320 in the thickness direction X of the main body portion 10. The fused portion 50 is formed only in the proximal portion 12 on the side (second surface) opposite to the region 15 in the thickness direction X. This configuration makes it easier to maintain the shape of the through hole 11, and prevents or suppresses fraying when the tissue reinforcement material 100 is punched out with the medical device 200.

[0075] Furthermore, in the method for manufacturing the tissue reinforcement material 100, a heated needle member 320 is penetrated through a sheet member S containing fibers made of a biodegradable material to form a through-hole 11, and the needle member 320 is heated with the needle penetrated through the main body portion 10, or the heated needle member 320 is penetrated through the main body portion 10 to form a fused portion 50 in the fibers surrounding the through-hole 11. By configuring in this manner, a tissue reinforcement material 100 can be manufactured in which the main body portion 10 has high rigidity and is less likely to twist.

[0076] 15 is a schematic diagram showing a manufacturing method according to a second embodiment for forming the fused portion 50 of the tissue reinforcement material 100. In this embodiment, the manufacturing method of the tissue reinforcement material 100 is different from that of the first embodiment, but the tissue reinforcement material 100 itself is similar to that of the first embodiment, and therefore a description of the tissue reinforcement material 100 will be omitted.

[0077] 15, multiple sheet members S containing a biodegradable material are stacked, and multiple thermally conductive needle members 320a, which do not have a base 310 as compared to the forming member 300 described in the first embodiment, are punctured into the sheet members to form through holes 11 in the sheet members S (S1). The multiple stacked sheet members S containing a biodegradable material may each have a different shape pattern of the through holes 11. For example, multiple sheet members S having through holes 11 arranged in two or more different shape patterns may be selected from the shape patterns of the through holes 11 of the main body 10 shown in FIGS. 3 to 6, and stacked.

[0078] Then, with the needles 320a puncturing the sheet member S, the needles 320a are maintained at a high temperature for a predetermined time. In this embodiment, the predetermined temperature can be set to a temperature at which the above-mentioned fibers melt or any temperature equal to or higher than the melting point of the above-mentioned fibers. As a result, the fused portions 50 are formed in the sheet member S (S2). In this embodiment, the fused portions 50 are formed (only) in the vicinity portions 12 on both sides (first surface and second surface) in the thickness direction X. After the needles 320a are heated, the sheet member S is cooled (S3), and the needles 320a are removed from the sheet member S (S4).

[0079] As described above, in this embodiment, the fused portion 50 is formed in the vicinity portion 12 on either side in the thickness direction X. By configuring in this manner, the shape of the through hole 11 can be easily maintained.

[0080] When the needle members 320a are heated after penetrating the sheet member S to form the through holes 11, the needle members 320a are maintained at a temperature equal to or higher than the melting point of the fibers. By configuring in this manner, the periphery of the through holes 11 can be melted to form fused portions 50 in the fibers around the through holes 11.

[0081] Furthermore, when the needle members 320a are penetrated through the sheet member S, the needle members 320a are penetrated through the sheet members S in a state in which a plurality of sheet members S are stacked on top of one another. Then, with the needle members 320a penetrated through the sheet members S, the state in which the needle members 320a are heated to a high temperature is maintained for a predetermined period of time. By configuring in this manner, it is also possible to obtain a tissue reinforcing material 100 in which fused portions 50 are formed in the fibers that make up the sheet member S.

[0082] The present invention is not limited to the above-described embodiment, and various modifications are possible within the scope of the claims. In the first embodiment, the sheet member S is punctured with a preheated needle member 320. However, the fibers may be processed by needle punching to be more entangled with each other than before the needle punching. This promotes entanglement between the fibers, and is expected to further increase the rigidity of the main body 10 when the fibers are fused together. Furthermore, in the second embodiment, needle punching may be performed on the sheet member S before the fused portion 50 is formed. Needle punching can promote entanglement between the fibers of multiple sheet members S. Furthermore, needle punching can loosen multifilaments, which are made up of multiple fibers, and promote entanglement between the fibers. Promoting entanglement between the fibers makes it easier to form the fused portion 50 when the fibers are fused together, thereby increasing the rigidity of the tissue reinforcement material 100.

[0083] In the first embodiment, the fused portion 50 is formed by piercing the sheet member S with the preheated needle member 320, but the base 310 may be heated after the needle member 320 has pierced the sheet member S without heating it. This configuration also makes it possible to form the fused portion 50 that can increase the rigidity of the main body 10 and make it less likely to twist. In the second embodiment, the needle member 320a is maintained at a high temperature for a predetermined period of time after piercing the sheet member S with the needle member 320a, but the needle member 320a may be heated before piercing the sheet member S with the needle member 320a.

[0084] (Experiment 1) The breaking elongation and breaking strength were confirmed as follows: In this experiment, the breaking elongation and breaking strength were confirmed when the tissue reinforcement materials according to the following examples and comparative examples were pulled using an Autograph AGS-1kNX (manufactured by Shimadzu Corporation).

[0085] As a preliminary preparation, a 0.05 mm thick Naflon sheet was cut to approximately 40 mm x 40 mm, and a 6 mm diameter hole was punched in the center with a biopsy trephine. A PTFE punched sheet was then cut to approximately 40 mm x 40 mm, and a 6 mm diameter hole was punched in the center with a biopsy trephine. A silicone rubber sheet was then punched to a diameter of 23 mm with a punch, and the center of this punched sheet was further punched with a 7 mm diameter punch. The punched silicone rubber sheet was then attached to the anvil (second device 250) of the medical device 200.

[0086] Next, for punching evaluation, a PTFE sheet was placed on top of the anvil. A Naflon sheet was then placed on top of the PTFE sheet, and a mesh cut to approximately 40 mm x 40 mm and with a 6 mm diameter hole drilled in the center using a biopsy trephine was placed on top of that. Another Naflon sheet was then placed on top of the PTFE sheet, and the mesh was sandwiched between the anvil and the main trocar (first instrument 210) of the medical device 200. The rotary knob on the first instrument 210 of the medical device 200 was then turned clockwise to bring the anvil and the main body closer together. While checking for any twisting in the mesh, the indicator was rotated until the bottom of the green bar was reached. The blade was then extended from the first instrument 210, punching was performed, and the handle was held in place for approximately 10 seconds. The grip was then released, and the rotary knob on the main body was turned counterclockwise to remove the anvil. The punched mesh was then removed. If the mesh became trapped in the silicone rubber sheet built into the inside of the anvil, it was gently pulled out using tweezers to avoid breaking the thread. The mesh was then observed to check for fraying or loosening between the mesh pieces after the blade had penetrated, and a judgment was made as to whether or not the mesh had been punched through. If there was no fraying, it was judged that the mesh had been punched through, and if there was fraying in two or more lines or in two or more places, it was judged that the mesh had not been punched through.

[0087] The detailed specifications of the examples and comparative examples are shown in Tables 1 and 2 below. The tissue reinforcement materials used in the experiments were made of PGA and had a roughly dumbbell-like shape measuring 20 mm wide and 30 mm long. The initial load measured by autograph was 0.029 N, the tensile speed was 6 mm / min (the tensile speed until the initial load was applied was 1 mm / min), the chuck distance was 14 mm, and the test temperature was 20-25°C. The tensile strength and stroke length were calculated using commercially available analytical software included with the tensile testing device. The tensile strength per width was calculated by dividing the tensile breaking strength (N) by the measured width (mm) of the sample. The elongation (%) was calculated by dividing the elongation (mm) by the chuck distance × 100. Figure 16 is a graph showing the breaking strength and breaking elongation in the first (longitudinal) direction of the tissue reinforcement material of Experiment 1, and Figure 17 is a graph showing the breaking strength and breaking elongation in the second (transverse) direction. 16 and 17 are plots of the breaking strength and breaking elongation in the first (vertical) direction and the breaking strength and breaking elongation in the second (horizontal) direction of the tissue reinforcement material of Experiment 1, based on the data in Tables 1 and 2. In Fig. 16 and 17, circles indicate those that were punched out, and squares indicate those that were not punched out.

[0088]

[0089]

[0090] Tables 1 and 2 confirm that punching was not possible with the specifications of the comparative example, but was possible with the specifications of the examples. From Table 1, it can be seen that the breaking elongation of the main body portion 10 in the first direction is less than 58% with Comparative Example 3. Furthermore, from Table 2, it can be seen that the breaking elongation of the main body portion 10 in the second direction does not exceed 74% with Example 5. From Table 1, it can be seen that the elongation in the first direction is 7% or more and 36% or less with Examples 10 and 17. From Table 2, it can be seen that the elongation in the second direction is 14% or more and 74% or less with Examples 5, 13, and 14. From Table 1, it can be seen that the breaking strength in the first direction is 0.22 N / mm or more with Example 14 and less than 1.19 N / mm with Comparative Example 2. From Table 2, it can be seen that the breaking strength in the second direction is 0.18 N / mm or more with Examples 2, 3, and 4 and less than 0.67 N / mm with Comparative Example 1. In this specification, the numerical values ​​for both Experiment 1 and Experiment 2 are rounded to the nearest digit (if the values ​​are expressed to the second decimal place, they are rounded to the third decimal place).

[0091] (Experiment 2) Next, an experiment was conducted on the initial Young's modulus of the tissue reinforcement material, which will be described. In this experiment, the initial Young's modulus and initial elongation rate were measured and punching was performed using a stapler using the specifications of the example and comparative example.

[0092] The detailed specifications of the examples and comparative examples are as shown in Table 3 below. The equipment, sample shape, chuck distance, tensile speed, initial load, and test temperature used in the experiment were the same as those in Experiment 1. In Experiment 2, the initial Young's modulus and initial elongation rate were determined using the analysis software attached to the tensile test equipment. The initial elongation rate (%) was calculated by the stroke length (mm) when a test force of 1 N was applied / chuck distance x 100. Initial Young's modulus (N / mm ２) was calculated as the Young's modulus at the time of initial elongation (between 2.5% and 5.0%). The ratio of the initial Young's moduli (longitudinal / lateral) was calculated as initial Young's modulus (longitudinal) / initial Young's modulus (lateral). The initial Young's modulus ratio (lateral / longitudinal) was calculated by initial Young's modulus (lateral) / initial Young's modulus (longitudinal) × 100. The specifications and punching results of the examples and comparative examples are shown in Table 3 below. Figure 18 is a graph showing the initial Young's modulus of the tissue reinforcement material according to Experiment 2, and Figure 19 is a graph showing the initial elongation. That is, Figures 18 and 19 are plots of the initial Young's modulus of the tissue reinforcement material according to Experiment 2 and the initial elongation of the tissue reinforcement material according to Experiment 2 based on the data listed in Table 3. In Figures 18 and 19, circles indicate punched-out specimens, and squares indicate specimens that could not be punched out.

[0093]

[0094] First, it was confirmed that punching was not possible with the specifications of the comparative example, but was possible with the specifications of the example. From Table 3, the initial Young's modulus in the first direction was 0.4 N / mm for the comparative example 2. ２ or more, and the initial Young's modulus in the second direction is 0.2 N / mm ２ It can be considered that the following is not included. In addition, the initial Young's modulus in the first direction is 2 N / mm ２ From Example 11, 20 N / mm ２ Furthermore, the initial Young's modulus in the second direction is 1 N / mm ２ From Example 11, it is 17 N / mm ２ It can be considered as follows.

[0095] FIG. 20 is a graph showing the relationship between the initial Young's modulus ratio in the second direction to the first direction and the initial Young's modulus ratio in the first direction to the second direction of the tissue reinforcement material in Experiment 2. If the initial Young's modulus ratio in the second direction to the first direction of the main body portion 10 is a and the initial Young's modulus ratio in the first direction to the second direction is b, the graph shows the relationship shown in FIG. 20, and this relationship can be expressed as an approximate equation b = 10,000 / a (50 < a ≦ 150). That is, FIG. 20 plots the initial Young's modulus ratio in the second direction to the first direction and the initial Young's modulus ratio in the first direction to the second direction of the tissue reinforcement material in Experiment 2 based on the data listed in Table 3. In FIG. 20, circles indicate punched-out samples, and squares indicate samples that were not punched-out. The approximate curve showing the approximate equation is also shown with a dotted line.

[0096] Furthermore, the initial elongation in the first direction can be considered to be 22% or less in Comparative Example 1 in Table 3, and the initial elongation in the second direction can be considered to be not more than 71% in Comparative Examples 1 and 2. Furthermore, the initial elongation in the first direction can be considered to be 0.3% or more in Example 11 and 2.4% or less in Example 14. The initial elongation in the second direction can be considered to be 0.5% or more in Example 11 and 6.0% or less in Example 5.

[0097] The present invention is not limited to the above-described embodiment, and various modifications are possible within the scope of the claims.

[0098] The present invention encompasses the following aspects and configurations.

[0099] (1) A tissue reinforcement material having a sheet-like main body portion containing fibers made of a biodegradable material, wherein the main body portion has a plurality of through holes formed therein, and the breaking elongation rate of the main body portion when pulled in a first direction is less than 58%, and the breaking elongation rate of the main body portion when pulled in a second direction intersecting the first direction does not exceed 74%.

[0100] (2) The tissue reinforcement material according to (1) above, wherein the breaking elongation in the first direction is 7% or more and 36% or less.

[0101] (3) A tissue reinforcement material according to (1) or (2) above, wherein the breaking elongation in the second direction is 14% or more and 74% or less.

[0102] (4) A tissue reinforcement material described in any one of (1) to (3) above, wherein the breaking strength when tensile in the first direction is 0.22 N / mm or more and less than 1.19 N / mm.

[0103] (5) A tissue reinforcement material according to any one of (1) to (4) above, wherein the breaking strength when tensile in the second direction is 0.18 N / mm or more and less than 0.67 N / mm.

[0104] (6) A tissue reinforcement material described in any of (1) to (5) above, wherein the initial elongation rate of the main body portion in the first direction is 22% or less, and the initial elongation rate in the second direction does not exceed 71%.

[0105] (7) The initial Young's modulus of the main body in the first direction is 0.4 N / mm ２ or more, and the initial Young's modulus of the main body in the second direction is 0.2 N / mm ２ The tissue reinforcement material according to any one of (1) to (6) above, which does not contain the following:

[0106] (8) A tissue reinforcement material according to any one of (1) to (7) above, wherein the knitted fabric of the main body portion is warp knitted or weft knitted.

[0107] (9) A tissue reinforcement material according to any one of (1) to (8) above, wherein the main body portion is needle-punched.

[0108] (10) A tissue reinforcement material according to any one of (1) to (9) above, wherein the main body is used by being sandwiched between an anastomotic site of a living organ.

[0109] (11) A tissue reinforcement material according to any one of (1) to (10) above, wherein the main body portion has a fused portion formed by the fibers gathering and fusing around the through hole.

[0110] (12) The tissue reinforcement material according to (11) above, wherein the through-hole is formed along the thickness direction of the main body portion, and the fused portion is formed along the thickness direction.

[0111] (13) A tissue reinforcement material described in (11) or (12) above, wherein the fused portion comprises a portion where the fibers are completely fused and a portion where the fibers are fused around the fibers while maintaining their shape.

[0112] (14) The main body portion has a proximal portion located near the through hole in the surface direction of the main body portion, and a distal portion that is farther away from the through hole in the surface direction than the proximal portion, and a tissue reinforcement material described in any of (11) to (13) above, in which the fibers are present at a higher density in the proximal portion than in the distal portion.

[0113] (15) The tissue reinforcement material according to (14) above, wherein the fused portion is formed in the vicinity thereof.

[0114] (16) A method for manufacturing a tissue reinforcement material described in any one of (11) to (15) above, comprising: penetrating a needle through the main body portion to form the through hole; heating the needle while it is penetrating the main body portion, or penetrating the heated needle through the main body portion to form the fused portion in the fibers around the through hole.

[0115] This application is based on Japanese Patent Application No. 2024-050731, filed on March 27, 2024, the disclosure of which is incorporated herein by reference in its entirety.

[0116] 10 main body portion, 11 through hole, 12 proximal portion, 13 distal portion, 50 fused portion, 51 first portion, 52 second portion, 100, 100a tissue reinforcement material, 310 base portion, 320, 320a needle member, S sheet member, X thickness direction, YZ surface direction.

Claims

1. A tissue reinforcement material having a sheet-like main body containing fibers made of a biodegradable material, wherein the main body has a plurality of through holes formed therein, the initial elongation rate of the main body in a first direction is 22% or less, and the initial elongation rate of the main body in a second direction intersecting the first direction does not exceed 71%.

2. The tissue reinforcement material according to claim 1, wherein the initial elongation in the first direction is 0.3% or more and 2.4% or less.

3. The tissue reinforcement material according to claim 1, wherein the initial elongation rate in the second direction is 0.5% or more and 6.0% or less.

4. A sheet-like main body portion containing fibers made of a biodegradable material, the main body portion having a plurality of through holes formed therein, and an initial Young's modulus in a first direction of the main body portion of 0.4 N / mm ２ or more, and the initial Young's modulus of the main body portion in a second direction intersecting the first direction is 0.2 N / mm ２ Tissue reinforcement materials that do not contain:

5. The initial Young's modulus in the first direction is 2 N / mm ２ 20N / mm or more ２ The tissue reinforcement material according to claim 4, wherein:

6. The initial Young's modulus in the second direction is 1 N / mm ２ More than 17N / mm ２ The tissue reinforcement material according to claim 4, wherein:

7. A tissue reinforcement material as described in claim 4, wherein when the initial Young's modulus ratio of the main body portion in the second direction to the first direction is a%, and the initial Young's modulus ratio of the main body portion in the first direction to the second direction is b%, b = 10000 / a50 < a ≦ 150 is satisfied.

8. The tissue reinforcement material according to claim 1, wherein the knitted fabric of the main body portion is warp knitted or weft knitted.

9. The tissue reinforcement material according to claim 1, wherein the main body portion is needle-punched.

10. The tissue reinforcement material according to claim 1, wherein the breaking elongation when stretched in the first direction is less than 58%, and the breaking elongation when stretched in the second direction does not exceed 74%.

11. A tissue reinforcement material according to any one of claims 1 to 8, wherein the main body is used by being sandwiched between an anastomotic site of a living organ.

12. The tissue reinforcement material according to claim 1, wherein the main body portion has a fused portion formed by gathering and fusing the fibers around the through-hole.

13. The tissue reinforcement material according to claim 10, wherein the through-holes are formed along the thickness direction of the main body portion, and the fused portions are formed along the thickness direction.

14. The tissue reinforcement material according to claim 10, wherein the fused portion comprises a portion where the fibers are completely fused and a portion where the fibers are fused around their peripheries while maintaining their shape.

15. The tissue reinforcement material described in claim 10, wherein the main body portion comprises a proximal portion located near the through-hole in the surface direction of the main body portion, and a distal portion that is farther away from the through-hole in the surface direction than the proximal portion, and the fibers are present at a higher density in the proximal portion than in the distal portion.

16. The tissue reinforcement material according to claim 13, wherein the fused portion is formed in the adjacent portion.

17. A method for manufacturing a tissue reinforcement material according to any one of claims 10 to 14, comprising: penetrating a needle through the main body portion to form the through-hole; and heating the needle while it is still penetrating the main body portion, or penetrating the heated needle through the main body portion to form the fused portion in the fibers around the through-hole.

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