Medical sheet and method for manufacturing medical sheet

Abstract

The present invention addresses the problem of improving the rigidity of a main body part constituting a medical sheet and preventing or suppressing distortion when disposed in a biological organ. [Solution] The present invention has a sheet-like main body part (10) containing fibers made of a biodegradable material, the main body part having a plurality of through-holes (11) formed therein, and having a fused part (50) in which the fibers are fused together around the through-holes.

Description

Technical Field

[0001] This invention relates to medical sheets and methods for manufacturing medical sheets. Background Technology

[0002] In the medical field, techniques for surgically joining biological organs (such as anastomosis of the digestive tract) are known. It is known that, in performing such techniques, it is important that the junction where the biological organs are joined does not experience delayed healing, as a key factor in postoperative prognosis.

[0003] In the technique of anastomosing biological organs, various methods and medical devices have been used, including methods such as suturing biological organs using biodegradable sutures and mechanical anastomosis devices using staplers. In particular, when using mechanical anastomosis devices, compared with methods using sutures, the bonding force between biological organs at the junction can be improved, thus reducing the risk of anastomotic leakage.

[0004] Existing technical documents Patent documents Patent Document 1: Japanese Patent Publication No. 2008-516678 Summary of the Invention

[0005] The problem that the invention aims to solve In the anastomosis device of Patent Document 1, to prevent leakage or breakage at the anastomosis site, a sheet-like component (hereinafter referred to as a medical sheet) is used to hold and support the structure to promote healing at the anastomosis site. Such medical sheets are usually thin and soft. The inventors of this application have conducted in-depth research on improving the rigidity of the main body of the medical sheet, preventing the medical sheet from twisting (bending or folding into a non-flat state) when placed in a biological organ, and preventing the medical sheet from unraveling (the state where the fibers spread out at the cut ends) during anastomosis using a mechanical anastomosis device.

[0006] Therefore, the object of the present invention is to improve the rigidity of the main body of the medical sheet and to prevent or suppress twisting and opening when disposed in a biological organ.

[0007] Methods for solving problems The present invention is implemented by any one of the means described in (1) to (14).

[0008] (1) A medical sheet having a sheet-like main body comprising fibers made of a biodegradable material, the main body having a plurality of through holes, and the aforementioned medical sheet having a fused portion formed by the fibers gathering and fusing around the through holes.

[0009] (2) The medical sheet as described in (1) above, wherein the aforementioned through hole is formed along the thickness direction of the aforementioned main body portion, and the aforementioned fusion portion is formed along the aforementioned thickness direction.

[0010] (3) The medical sheet as described in (1) or (2) above, wherein the aforementioned fusion portion comprises: a portion in which the aforementioned fibers are completely fused; and a portion in which the shape of the aforementioned fibers is maintained and the periphery of the aforementioned fibers is fused.

[0011] (4) The medical sheet as described in any one of (1) to (3) above, wherein the aforementioned main body portion comprises: a nearby portion located near the aforementioned through hole in the surface direction of the aforementioned main body portion; and a distal portion separated from the aforementioned through hole in the surface direction compared to the aforementioned nearby portion. Compared to the aforementioned distal portion, the aforementioned fibers are present at a high density in the aforementioned nearby portion.

[0012] (5) The medical sheet as described in (4) above, wherein the aforementioned fusion portion is formed in the aforementioned nearby portion.

[0013] (6) The medical sheet as described in (4) or (5) above, wherein the aforementioned main body portion has a first surface and a second surface formed on the opposite side to the first surface, the aforementioned fusion portion is formed in the aforementioned nearby portion and the aforementioned distant portion of the aforementioned first surface, and is formed only in the aforementioned nearby portion of the aforementioned second surface.

[0014] (7) The medical sheet as described in any one of (1) to (6) above, wherein the main body portion comprises multifilaments of the aforementioned fibers, and at least a portion of the aforementioned multifilaments in the fused portion are fused together.

[0015] (8) A method for manufacturing a medical sheet, wherein a needle is passed through a sheet component containing fibers made of a biodegradable material to form a through hole, and the needle is heated while the needle is passing through the sheet component, or The heated needle is made to penetrate the sheet component, thereby forming a fused portion of the fibers around the through hole.

[0016] (9) The method for manufacturing a medical sheet as described in (8) above, wherein, when the needle is heated after passing through the sheet component to form the through hole, or when the heated needle passes through the sheet component, the needle is heated to a temperature above the melting temperature of the fiber.

[0017] (10) The method for manufacturing a medical sheet as described in (8) above, wherein, when the needle is heated after passing through the sheet component to form the through hole, or when the heated needle passes through the sheet component, the needle is heated to above the melting point of the fiber.

[0018] (11) The method for manufacturing a medical sheet as described in any one of (8) to (10) above, wherein, after the needle is heated to form the through hole by passing through the sheet component, and while the planar base on which the needle is disposed is in contact with the sheet component, the needle is heated by heating the base to form the fusion portion.

[0019] (12) The method for manufacturing a medical sheet as described in any one of (8) to (10) above, wherein, when the needle is heated after passing through the sheet component to form the through hole, or when the heated needle passes through the sheet component, the needle passes through the sheet component while multiple sheets of the aforementioned sheet component are overlapped. Heating the aforementioned needle is performed by maintaining the aforementioned needle at a specified temperature for a specified time.

[0020] (13) A method for manufacturing a medical sheet as described in any one of (8) to (12) above, wherein, before the needle passes through the sheet component, the fibers of the plurality of sheet components are needle-punched, such that the fibers of the plurality of sheet components are intertwined with each other compared to before the needle-punching.

[0021] (14) The method for manufacturing a medical sheet as described in any one of (8) to (13) above, wherein, after heating the aforementioned needle, the aforementioned sheet component is cooled. Remove the aforementioned needle from the aforementioned sheet component.

[0022] Invention Effects According to the medical sheet described in (1) to (7) above and the manufacturing method of the medical sheet described in (8) to (14) above, the rigidity of the main body of the medical sheet can be improved, and the twisting and opening when disposed in a biological organ can be prevented or suppressed. Attached Figure Description

[0023] [ Figure 1 This is a perspective view showing the medical sheet involved in the embodiment.

[0024] [ Figure 2 This is an enlarged cross-sectional view showing the through hole in the main body of a medical sheet.

[0025] [ Figure 3[A diagram showing the shape pattern of a through hole in a medical sheet.]

[0026] [ Figure 4 [A diagram illustrating the shape pattern involved in a deformation example of a through hole in a medical sheet.]

[0027] [ Figure 5 [A diagram illustrating the shape pattern involved in a deformation example of a through hole in a medical sheet.]

[0028] [ Figure 6 [A diagram illustrating the shape pattern involved in a deformation example of a through hole in a medical sheet.]

[0029] [ Figure 7 To show Figure 1 The variation example involves a three-dimensional view of a medical sheet.

[0030] [ Figure 8 This is an exploded perspective view of a portion (front end) of a medical device used in the anastomosis of biological organs with medical sheets.

[0031] [ Figure 9 This is an enlarged image showing the welded portion of a medical sheet.

[0032] [ Figure 10 This is an enlarged image showing the welded portion of a medical sheet.

[0033] [ Figure 11 This is an enlarged image showing the welded portion of a medical sheet.

[0034] [ Figure 12 This is a flowchart illustrating a method for manufacturing a medical sheet according to an embodiment.

[0035] [ Figure 13 [A diagram showing the needle component used in the manufacturing method of the medical sheet according to the first embodiment.]

[0036] [ Figure 14 This is a schematic diagram illustrating the process of forming a through hole in a sheet component using a needle component.

[0037] [ Figure 15 [A diagram showing the needle component used in the manufacturing method of the medical sheet according to the second embodiment.] Detailed Implementation

[0038] <First Implementation> Hereinafter, the embodiments for carrying out the present invention will be described in detail with reference to the accompanying drawings. The embodiments shown herein are illustrative of the technical concept of the present invention and are not intended to limit the present invention. Furthermore, all other embodiments, implementation methods, and techniques that can be implemented and conceived by those skilled in the art without departing from the scope of the present invention are included in the scope and spirit of the present invention, and are included within the scope of the invention as set forth in the claims and its equivalents.

[0039] Furthermore, regarding the accompanying drawings, for the purpose of illustration and understanding, the scale, aspect ratio, shape, etc., are sometimes appropriately changed compared to the actual object to make schematic representations, but this is only one example and does not limit the interpretation of the present invention.

[0040] In addition, the following descriptions use ordinal numbers such as "the first" and "the second" for convenience, but unless otherwise specified, they are used for convenience and do not stipulate any order.

[0041] <Medical Sheets> Figure 1 A perspective view of the medical sheet 100 according to the embodiment is shown. Figure 2 This is an enlarged view showing the through-holes 11 of the medical sheet. The medical sheet 100 is configured to be sandwiched between two or more biological organs (the joined parts of one and another) that are to be anastomosed, and is formed as a flat sheet with multiple through-holes 11. Here, "configured between two or more biological organs that are to be anastomosed" means that the medical sheet 100 is configured in a state of direct or indirect contact with the biological organ, in a state where the medical sheet 100 forms a spatial gap with the biological organ, or in a state where the medical sheet 100 is configured in at least one of these two states (e.g., the medical sheet 100 is in contact with one biological organ and not in contact with the other biological organ). Examples of biological organs include, for example, luminal organs such as the large intestine, jejunum, and pancreatic duct. Figure 1 As shown, the medical sheet 100 includes a main body 10, a reinforcing portion 20, a fixing portion 30, a hole portion 40, and a fusion portion 50. It should be noted that the medical sheet 100 may also omit the reinforcing portion 20 and the fixing portion 30, and be composed solely of the main body 10, the hole portion 40, and the fusion portion 50. Alternatively, the medical sheet 100 may also omit the reinforcing portion 20, and be composed solely of the main body 10, the fixing portion 30, the hole portion 40, and the fusion portion 50. It should be noted that an orthogonal coordinate system is shown in some of the figures; the surface direction of the main body 10 will be referred to as the surface direction YZ, and the thickness direction as the thickness direction X. A detailed description follows.

[0042] <Main Body> The main body 10 is disposed between the biological organs that are to be anastomosed (e.g., the large intestine, pancreatic duct, and jejunum), and is configured as a sheet that can follow the movements of the biological organs that are to be anastomosed.

[0043] Main body 10 Figure 1 The land shown is formed into a circular shape as an example, such as Figure 2 The main body 10 is provided with a plurality of through holes 11 formed in a manner that allow insertion along the thickness direction X (axial direction) of the circular shape. Taking the size (diameter D) of the through holes 11 in the main body 10 as an example, it 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 through holes 11 in the main body 10 can promote a healing effect. The size of the through holes 11 can be configured such that... Figure 2 The distance shown is the diameter D of the through hole 11 and the spacing P (where D is the distance between the two holes). Figure 2 The ratio of the distance shown (the distance between the opening edges of the two through holes 11) is 0.25 or more and less than 40. Since the main body 10 has multiple through holes 11, there are multiple values ​​for the aperture D corresponding to each through hole 11. Therefore, in this embodiment, when calculating the value of the above ratio, the arithmetic mean of two or more aperture D values ​​corresponding to each of the multiple through holes 11 is used as the representative value of aperture D. On the other hand, the spacing P of the multiple through holes 11 is defined by the shortest distance between the openings of two through holes 11. There are also multiple values ​​for the spacing P corresponding to combinations of adjacent through holes 11. Therefore, in this embodiment, when calculating the value of the above ratio, the arithmetic mean of two or more spacing P values ​​corresponding to combinations of adjacent through holes 11 is used as the representative value of spacing P. The spacing P is an example and can be periodic or random. It should be noted that the (perfect) circle described as the shape of the main body 10 is an example. In addition to the above, it can also be configured as a polygon including an ellipse, a quadrilateral, a star, etc.

[0044] Figure 3 This diagram illustrates the shape and pattern of the through hole 11 in the main body 10. Figures 4 to 6 A diagram showing the shape pattern of a modified example of the through hole 11 in the main body 10. Figure 2 and Figure 3 In the diagram, the through holes 11 are shown with the same shape and equal spacing. However, the shape and pattern of the through holes 11 are not limited to this. In addition to the above, they can also be shown as follows: Figure 4 As shown, through holes 11 of different sizes are arranged at equal intervals, such as Figure 5 As shown, through holes of the same size are arranged with a 60° staggered spacing (alternating arrangement), such as Figure 6The diagram shows through holes 11 of different sizes arranged randomly.

[0045] The thickness of the main body 10 ( Figure 2 The dimension T shown is not particularly limited, but is preferably 0.05 to 0.7 mm, more preferably 0.25 to 0.45 mm. It should be noted that the values ​​for the thickness, size, and other dimensions described above are merely examples, and dimensions other than those described are also possible. It should be noted that when the thickness T of the main body 10 is 0.7 mm or less (especially 0.45 mm or less), the flexibility of the main body 10 can be improved. This allows the main body 10 to fit snugly against the biological organ, improving its ability to follow the movement of the biological organ. On the other hand, if the thickness T 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 will twist and be difficult to place between the biological organs to be fitted.

[0046] The main body 10 can be made from a sheet-like molded material, which is constructed by multifilamentizing multiple fibers (e.g., filaments) made of a biodegradable material, and then weaving or knitting the resulting multifilaments. That is, the main body 10 can be made of a biodegradable sheet. There are no particular limitations on the constituent materials of the main body 10; for example, biodegradable resins can be used.

[0047] Examples of biodegradable resins include (1) polymers selected from the group consisting of aliphatic polyesters, polyesters, polyanhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphates, polyvinyl alcohol, polypeptides, polysaccharides, proteins, and cellulose; and (2) copolymers composed of one or more monomers constituting (1) above.

[0048] That is, the biodegradable sheet preferably comprises at least one biodegradable resin selected from the group consisting of polymers selected from the group consisting of polymers selected from the group consisting of polymers selected from the group consisting of aliphatic polyesters, polyesters, polyanhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphates, polyvinyl alcohol, polypeptides, polysaccharides, proteins, and cellulose. The body portion 10 preferably comprises, for example, a bioabsorbable material such as polyglycolic acid (PGA) or PLGA (polylactic acid-glycolic acid copolymer).

[0049] The main body 10 is made by non-woven fabrication of a sheet obtained from processing biodegradable fibers, followed by a process of forming through holes 11 accompanied by heating. The main body 10 thus formed induces a biological response through the biodegradable resin or other constituent materials constituting the main body 10. The main body 10 induces the expression of biological components such as fibrin through this action. The biological components thus induced accumulate from both sides in the YZ direction through the through holes 11 of the main body 10, thereby promoting healing. Therefore, by leaving the main body 10 of the medical sheet 100 in a clamped state between biological organs that are to be joined (e.g., between intestinal segments undergoing colon anastomosis, between the cut surfaces of intestinal segments undergoing colon anastomosis, between pancreatic parenchyma and jejunum), healing is promoted based on the above mechanism.

[0050] <Enhancement Department> The reinforcing part 20 is provided to suppress twisting, misalignment, breakage, and detachment of the medical sheet 100 when it is placed between the first joined portion (one joined portion) and the second joined portion (the other joined portion). The reinforcing part 20 is formed along the outer periphery in the hollow circular shape of the main body 10.

[0051] In this embodiment, the reinforcing portion 20 is constructed with a higher rigidity than the main body portion 10. In this embodiment, the reinforcing portion 20 is configured such that no through-hole 11 is provided in the main body portion 10. The reinforcing portion 20 preferably comprises a bioabsorbable material such as a thermoplastic resin like PGA (polyglycolic acid), PLA (polylactic acid), PLGA (polylactic acid-glycolic acid copolymer), PDS (polydioxanone), or PCL (polycaprolactone). However, the reinforcing portion 20 may also comprise a non-bioabsorbable material.

[0052] Furthermore, the reinforcing portion 20 can be provided all over the entire circumference of the main body portion 10 in the outer direction of the YZ direction, or it can be provided locally at one or more locations within the entire circumference. Here, the outer direction refers to the direction away from the center point Pt (imaginary point) of the medical sheet 100 in the YZ direction. The direction in the YZ direction closer to the center point Pt of the medical sheet 100 is the inner direction. The reinforcing portion 20 can be joined to the main body portion 10 using adhesives, thermal fusion, or it can be sewn together using silk or the like. It should be noted that the reinforcing portion 20 may also be omitted. Figure 7 A perspective view is provided for a modified example of a medical sheet 100a that does not have the reinforcing part 20. (See attached image.) Figure 7As shown, the medical sheet 100 may also be composed of a main body 10, a fixing part 30, a hole part 40, and a welding part 50. In the absence of the reinforcing part 20, the outer periphery of the medical sheet 100 is composed of a main body 10 that is continuous in the outward direction from the main body 10 and has a through hole 11.

[0053] Figure 8 This is an exploded perspective view showing the front end of a medical device 200 used when placing a medical sheet 100 onto a biological organ. The medical device 200 includes a first engaging device 210 and a second engaging device 250. The medical device 200 may also be referred to as an anastomosis device, the first engaging device 210 may also be referred to as a cannula, and the second engaging device 250 may also be referred to as an anvil. A portion of the outer side of the reinforcing portion 20 and the main body portion 10 (the main body portion 10 near the inner periphery of the reinforcing portion 20) is integrated with the first and second joined portions in such a way that a staple released from the release portion 240 of the first engaging device 210 of the medical device 200 and the clamping portion 270 of the second engaging device 250 opposite to the release portion 240 are clamped and deformed together.

[0054] <Fixed part 30> The fixing part 30 is configured to prevent or suppress misalignment and detachment of the medical sheet 100 when it is positioned between the first and second joint portions. The fixing part 30 is formed along the inner periphery of the hollow circular shape of the main body portion 10. That is, the fixing part 30 is formed in a manner that surrounds the center portion Pt (imaginary point) of the medical sheet 100 in the YZ direction. Therefore, the medical sheet 100 is composed of: a circular reinforcing part 20 formed to surround the center portion Pt of the medical sheet 100; a main body portion 10 formed to surround the outer periphery of the reinforcing part 20; and a reinforcing part 20 formed to surround the outer periphery of the main body portion 10. In the medical sheet 100, the fixing part 30, the main body portion 10, and the reinforcing part 20 are arranged sequentially from the center portion Pt outward in the YZ direction.

[0055] The fixing part 30, like the reinforcing part 20, is configured such that no through hole 11 is provided in the main body part 10. The fixing part 30 can be made of the same material as the reinforcing part 20.

[0056] The fixing part 30 can be provided all over the circumference of the inner side of the main body 10 in the YZ direction, or it can be provided at one or more locations in the circumference. Furthermore, the fixing part 30 is coaxially formed with the inner edge, but its center position can be offset from the main body 10 as long as it does not enter the healing area. During operation, the fixing part 30 and the inner side of the main body 10 are penetrated by the penetrating part 230 of the first engaging device 210 of the medical device 200, thereby separating them from the outer side of the main body 10 and the reinforcing part 20. It should be noted that the fixing part 30 may also be omitted. Without the fixing part 30, the inner periphery of the medical sheet 100 is formed by a continuous main body 10 extending inward from the main body 10 and having a through hole 11.

[0057] <Kong section> The hole 40 is separated from the outer periphery of the main body 10 in the YZ direction and is formed by the fixing part 30 in this embodiment. The hole 40 is configured to allow the shaft 260 of the second engaging device 250 of the medical device 200 to pass through. In this embodiment, the hole 40 has a diameter larger than the diameter D of each through hole 11, and is therefore configured to allow the shaft 260 to pass through. The shaft 260 of the second engaging device 250 is configured to accommodate the positioning part 220 of the first engaging device 210.

[0058] In this embodiment, the hole 40 is configured to be approximately circular 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 the healing of biological tissue. The cross-section of the hole 40 is preferably a perfect circle, but it can also be configured as a linear, elliptical, triangular, quadrangular, concave, convex, cross-shaped, or other cuts.

[0059] <Fusion section> Figures 9 to 11 This image shows a portion of the fusion portion 50. The fusion portion 50 is configured as a region where fibers gather and fuse around the through hole 11. The through hole 11 of the main body 10 is formed along the thickness direction X of the main body 10. The fusion portion 50 is configured to be formed along the thickness direction X.

[0060] like Figure 10 As shown, the fusion portion 50 includes: Figure 9The diagram shows a first part 51 where the fibers are completely fused together; and a second part 52 where the fibers maintain their shape and are fused together around their periphery. Here, "completely fused" means the fibers are so tightly integrated that they are indistinguishable even when examined under a microscope. "Maintaining the shape of the fibers and being fused together around their periphery" means the fibers are not completely integrated (so tightly integrated that they are indistinguishable even when examined under a microscope), but have portions where the fibers are fused together around their periphery and become integrated with each other (so tightly integrated that they can be distinguished when examined under a microscope). Figure 11 As shown, the main body 10 includes: a nearby portion 12 located near the through hole 11 in relation to the fusion portion 50; and a distal portion 13 separated from the through hole 11 in the planar direction YZ compared to the nearby portion 12. The nearby portion 12 includes the opening edge of the through hole 11. The distal portion 13 includes the central periphery of the distance (pitch P) between the two through holes 11. Here, in the main body 10, the range from the edge of one through hole 11 to the length between adjacent through holes 11 is less than 50%, which can be called the nearby portion 12, and the remaining range can be called the distal portion 13. The nearby portion 12 is configured such that the fibers are present at a higher density compared to the distal portion 13.

[0061] The fusion portion 50 is configured such that, as described later, it is formed on one side (the first surface) in the thickness direction X, in the nearby portion 12 and the distant portion 13, and on the other side (the second surface, opposite to the first surface), it is formed only in the nearby portion 12. The fusion portion 50 can be formed by fusing at least a portion of a multifilament composed of multiple fibers together. However, the fusion portion 50 can also be formed by fusing at least a portion of the fibers (filaments) of the multifilament together. The size of the fusion portion 50 is not particularly limited, but by example, it can be configured to be from 0.015 mm to 0.7 mm. The fusion portion 50 can be configured such that its proportion to the unmelted portion is more than 3% and less than 100%. In addition, when viewed from above (in the thickness direction X) of the main body portion 10, the occupancy of the fusion portion 50 relative to the main body portion 10 can be configured to be more than 0.002%.

[0062] <Method for forming the fusion section> Next, the method for forming the fusion portion 50 in the medical sheet 100 will be described. Figure 12 A flowchart illustrating a method for forming a medical sheet 100 according to an embodiment is provided. Figure 13 The diagram illustrates the needle component 320 used in the method for forming the fusion portion 50 according to the first embodiment. Figure 14This diagram illustrates the formation of a through-hole 11 in a sheet component S used when forming a fusion portion 50 in a medical sheet 100. The sheet component S is a sheet-like component containing fibers made of a biodegradable material without the through-hole 11 formed.

[0063] In one example of the method for forming the fusion portion 50, such as Figure 13 As shown, a forming member 300 with numerous heat-conducting needle components 320 is provided at the front end of a base 310 having a circular plane, which serves as a base. A component capable of heating by generating ultrasound or the like is built into the base 310 of the forming member 300. By generating heat in the base 310, heat can be conducted to the multiple needle components 320. In this embodiment, the forming member 300 is preheated. The needle components 320 are heated to a temperature above the melting point of the fibers 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 above; or for PLGA, approximately 200°C, 215°C, or above). Then, the needle components 320 are inserted into a pre-processed sheet component S (S1) of the medical sheet 100, bringing the base 310 into contact with the sheet component S and applying pressure.

[0064] Therefore, as Figure 14 As shown, in the sheet component S, the area around the edge of the through hole 11 formed by the needle component 320 (corresponding to the near portion 12 of the main body portion 10) is heated and melted by the needle component 320, and the fibers around the through hole 11 are melted together to form a fused portion 50 (S2). In this embodiment, the needle component 320 has a shape in which a cylindrical portion and a conical portion with the same diameter are overlapped at the base 310, but the shape of the needle component 320 is not particularly limited as long as the through hole 11 can be formed with the target aperture D. For example, the needle component 320 can be conical, pyramidal, cylindrical, tapered, etc. In addition, the needle component 320 can have the same or equal diameter as the aperture D. In this embodiment, the diameter of the cylindrical portion and the diameter of the bottom surface of the conical portion of the needle component 320 have the same diameter as the aperture D, and the cylindrical portion penetrates the sheet component S to make a through hole. However, as long as a through hole 11 can be formed with the target aperture D, the cylindrical part may not penetrate the sheet component S.

[0065] Figure 14Part 14 represents the area in sheet component S where the needle component 320 directly contacts the material, and part 15 represents the area in which the base 310 directly contacts the material (first side). The parts 14 and 15 where the base 310 and needle component 320 directly contact each other have a greater heat load than the parts where the base 310 and needle component 320 do not directly contact each other (second side). Therefore, when viewed from the thickness direction X, the fibers of one side of sheet component S (front side, parts 14 and 15 where the base 310 and needle component 320 directly contact each other, first side) are more fused, resulting in increased rigidity compared to the other side (back side, parts where the base 310 and needle component 320 do not directly contact each other, second side).

[0066] In addition, such as Figure 14 As shown, the surface (part 15) of the sheet member S in contact with the base 310 is an uneven plane due to the fibers, thus there are portions that do not directly contact the base 310. It should be noted that the through-hole 11 is formed by the fibers of the sheet member S that avoid the edge of the hole perforated by the needle member 320 (corresponding to the near portion 12 of the main body 10). Therefore, the fiber density in the near portion 12 of the through-hole 11 is higher than that in the distal portion 13. That is, the density of the through-hole 11 is higher than the density of the surface of the sheet member S. The portion 15, where the fibers are locally melted and fused by heating through contact with the base 310, is formed only on one side of the main body 10, thus enabling the main body 10 to possess both a certain degree of flexibility and rigidity. It should be noted that on the side directly in contact with the base 310 when viewed from the thickness direction X (front side, portions 14 and 15 where the base 310 and the needle component 320 directly contact, first side), the fusion portion 50 is formed in the nearby portion 12 and the distal portion 13. On the other side where the base 310 and the needle component 320 do not directly contact (back side, portions where the base 310 and the needle component 320 do not directly contact, second side), the fusion portion 50 is formed only in the nearby portion 12. The portion separated from the nearby needle component 320 (corresponding to the distal portion 13 of the main body portion 10) will not completely melt due to heat, but will slightly melt due to heat conduction, thus forming the fusion portion 50 in a state where the fibers are not completely melted. The fusion portion 50 can be formed by fusing the filaments between multifilaments or by fusing bundled multifilaments together. However, fusing bundled multifilaments together can be expected to improve rigidity.

[0067] The number of sheet components S used to form the main body 10 is not particularly limited; it can be one sheet or two or more sheets, preferably two to eight sheets. Four sheets provide a good balance between heating conditions and intensity, and are therefore a further preferred option. By forming the through hole 11 while applying heat, the area around the edge can be melted, making it easy to maintain the shape of the through hole 11.

[0068] After heating the needle component 320, the sheet component S is cooled (S3), and the needle component 320 is removed from the sheet component S (S4). The cooling method is not particularly limited; natural cooling or forced cooling such as blowing air can be used. Cooling can be performed while the needle component 320 is inserted, or after the needle component 320 has been removed from the sheet component S. If the heated needle component 320 is pierced and processed as described above, and then separated from the sheet component S and cooled, a protrusion can be formed around the edge. This protrusion facilitates positioning. Furthermore, by changing the temperature, time, pressure, needle diameter, spacing, etc., during hot pressing, the hardness of the sheet component S, the size and distribution of the through holes can be adjusted.

[0069] As explained above, the medical sheet 100 according to this embodiment has a sheet-like main body 10 comprising fibers made of a biodegradable material. The main body 10 has a plurality of through holes 11 and a fusion portion 50 formed by the fibers gathering and fusing around the through holes 11. This configuration makes it easy to maintain the shape of the through holes 11 in the main body 10. Furthermore, by configuring the fusion portion 50 as described above, the rigidity of the main body 10 can be increased, preventing or suppressing the occurrence of twisting or misalignment of the medical sheet 100. Additionally, by increasing the rigidity of the main body 10, it is possible to prevent or suppress unraveling when a stapler such as a medical device 200 penetrates the medical sheet 100, and penetration is facilitated.

[0070] Furthermore, the through hole 11 is formed along the thickness direction X of the main body 10. The fusion portion 50 is also formed along the thickness direction X. Therefore, it is easy to improve the rigidity of the main body 10, which helps to prevent or suppress twisting in the medical sheet 100.

[0071] Furthermore, the fusion portion 50 includes a first portion 51 in which the fibers are completely fused together, and a second portion 52 in which the shape of the fibers is maintained and the periphery of the fibers is fused together. In this way, the fusion portion 50 contains not only the second portion 52 but also the first portion 51, so that biological components can easily enter the gaps between the fibers and can easily exert a healing effect.

[0072] Furthermore, the main body 10 includes a nearby portion 12 located near the through hole 11 in the YZ direction of the main body 10, and a distal portion 13 that is separated from the through hole 11 in the YZ direction compared to the nearby portion 12. The nearby portion 12 is perforated by the needle member 320 using the aforementioned method, causing the fibers to distribute in a way that avoids the surrounding area, thereby constituting a higher fiber density compared to the distal portion 13. This configuration easily improves the strength of the main body 10, thereby making it easier to maintain the shape of the through hole 11.

[0073] Furthermore, the fusion portion 50 is formed in the thickness direction X of the main body portion 10, specifically in the portion 15 (first surface) that directly contacts the base portion 310 and the needle component 320, in both the nearby portion 12 and the distal portion 13. The fusion portion 50 is also formed only in the nearby portion 12 in the thickness direction X, on the opposite side (second surface) from the portion 15. This configuration facilitates the maintenance of the shape of the through hole 11 and prevents or suppresses opening when the medical device 200 penetrates the medical sheet 100.

[0074] Furthermore, the main body 10 includes multifilaments of fibers. The fusion portion 50 can be constructed such that at least a portion of the multifilaments are fused together. By constructing it in this way, the strength of the main body 10 can be easily improved.

[0075] Furthermore, in the manufacturing method of the medical sheet 100, it is configured such that a heated needle component 320 passes through a sheet component S containing fibers made of a biodegradable material to form a through hole 11, and a fusion portion 50 is formed by the heated needle component 320 around the fibers of the through hole 11. With this configuration, a medical sheet 100 with high rigidity and resistance to twisting of the main body 10 can be manufactured.

[0076] Furthermore, when the heated needle component 320 passes through the sheet component S, the needle component 320 is heated to above the melting point of the fiber or above the temperature at which the fiber melts. With this configuration, the area around the through hole 11 can be melted, and a fused portion 50 can be formed in the fiber around the through hole 11.

[0077] In this embodiment, the base 310, on which the needle member 320 is disposed, is heated beforehand while in contact with the sheet member S, thereby heating the needle member 320 to form a fusion portion 50. With this configuration, a fusion portion 50 that improves the rigidity of the main body 10 and is less prone to twisting can be formed.

[0078] Furthermore, in this embodiment, the sheet component S is configured such that after heating the needle component 320, it is cooled and then removed from the needle component 320. With this configuration, a medical sheet 100 having the fusion portion 50 formed can be obtained.

[0079] (Second Implementation) Figure 15 This is a schematic diagram illustrating the manufacturing method according to the second embodiment of forming the fusion portion 50 of the medical sheet 100. In this embodiment, although the manufacturing method of the medical sheet 100 is different from that of the first embodiment, the medical sheet 100 itself is the same as that of the first embodiment, so the description of the medical sheet 100 is omitted.

[0080] In this embodiment, such as Figure 15 As shown, multiple sheets S containing biodegradable material are overlapped, and multiple thermally conductive needles 320a, which have no base 310 relative to the forming member 300 described in the first embodiment, are pierced into the sheets S, thereby forming through holes 11 (S1) in the sheets S. The multiple sheets S containing biodegradable material that are overlapped may also have different shapes and patterns of through holes 11. For example, from Figures 3 to 6 The sheet component S with through holes 11 arranged in two or more different shape patterns is selected from the shape pattern of the through hole 11 of the main body 10 shown, and multiple sheets are overlapped.

[0081] Then, with the needle component 320a piercing the sheet component S, the needle component 320a is maintained at a high temperature for a predetermined time. In this embodiment, the predetermined temperature can be set to any temperature above or above the melting point of the fiber. As a result, a fusion portion 50 is formed in the sheet component S (S2). In this embodiment, the fusion portion 50 is formed (only) in the adjacent portion 12 on either side (the first surface and the second surface) in the thickness direction X. After heating the needle component 320a, the sheet component S is cooled (S3), and the needle component 320a is removed from the sheet component S (S4).

[0082] As described above, in this embodiment, the fusion portion 50 is formed on either side of the proximity portion 12 in the thickness direction X. With this configuration, it is easy to maintain the shape of the through hole 11.

[0083] When the needle component 320a is heated after it has passed through the sheet component S to form a through hole 11, the needle component 320a is maintained at a temperature above the fiber melting point. With this configuration, the area around the through hole 11 can be melted, and the fibers around the through hole 11 can form a fused portion 50.

[0084] Furthermore, when the needle component 320a penetrates the sheet component S, the needle component 320a is penetrated through the sheet component S while multiple sheet components S are overlapped. Also, while the needle component 320a penetrates the sheet component S, the needle component 320a is maintained at a high temperature for a predetermined time. With this configuration, a medical sheet 100 in which a fusion portion 50 is formed in the fibers constituting the sheet component S can be obtained.

[0085] It should be noted that the present invention is not limited to the embodiments described above, and various modifications can be made within the scope of the claims. In the first embodiment, it is described that a preheated needle component 320 is pierced into the sheet component S, but it can also be processed by entanglement of the fibers by needle punching compared to before needle punching. This promotes the entanglement between fibers, and it is expected that the rigidity of the main body 10 can be further improved when the fibers are fused together. In addition, in the second embodiment, the sheet component S can be needle punched before the fusion portion 50 is formed. By needle punching, the entanglement between the fibers of multiple sheet components S can be promoted. In addition, by needle punching, the multifilament formed by the aggregation of multiple fibers can be loosened, and the entanglement between fibers can be promoted. By promoting the entanglement between fibers, the fusion portion 50 is easily formed when the fibers are fused together, and the rigidity of the medical sheet 100 can be improved.

[0086] Furthermore, in the first embodiment, it is described that a preheated needle member 320 is pierced into the sheet member S to form a fusion portion 50. However, it is also possible to configure the base 310 to be heated after the unheated needle member 320 is pierced into the sheet member S. With this configuration, a fusion portion 50 that can improve the rigidity of the main body 10 and is less prone to twisting can be formed. In addition, in the second embodiment, it is described that the needle member 320a is pierced into the sheet member S and then maintained at a high temperature for a predetermined time. However, it is also possible to configure the needle member 320a to be heated before piercing into the sheet member S.

[0087] This application is based on Japanese Patent Application No. 2023-164236, filed on September 27, 2023, the disclosure of which is incorporated herein by reference in its entirety.

[0088] Explanation of reference numerals in the attached figures 10. Main body section 11 Through holes 12 Nearby areas 13. Distal region 50 Fusion section 51 Part 1 52 Part 2 100, 100a medical sheets 310 base 320, 320a pin components S-sheet components, X thickness direction YZ plane direction.

Claims

1. A medical sheet having a sheet-like main body comprising fibers made of a biodegradable material. The main body has a plurality of through holes, and the medical sheet has a fused portion formed by the fibers gathering and fusing around the through holes.

2. The medical sheet as described in claim 1, wherein, The through hole is formed along the thickness direction of the main body. The fusion portion is formed along the thickness direction.

3. The medical sheet as described in claim 1, wherein, The fusion portion includes: a portion in which the fibers are completely fused; and a portion in which the shape of the fibers is maintained and the periphery of the fibers is fused.

4. The medical sheet as described in claim 1, wherein, The main body includes: a nearby portion located near the through hole in the surface direction of the main body; and a distal portion that is separated from the through hole in the surface direction compared to the nearby portion. Compared to the distal portion, the fibers in the proximal portion exist at a high density.

5. The medical sheet as described in claim 4, wherein, The fusion portion is formed in the vicinity of the fusion portion.

6. The medical sheet as described in claim 4, wherein, The main body has a first surface and a second surface formed on the opposite side of the first surface. The fusion portion is formed in the nearby portion and the distant portion of the first surface, and is formed only in the nearby portion of the second surface.

7. The medical sheet as described in claim 1, wherein, The main body comprises multifilaments of the fiber. At least a portion of the multifilaments in the fusion section are fused together.

8. A method for manufacturing medical sheets, wherein, A through-hole is formed by passing a needle through a sheet component containing fibers made of biodegradable material; the needle is then heated while it is passing through the sheet component. The heated needle is passed through the sheet component, thereby forming a fused portion of the fibers around the through hole.

9. The method for manufacturing a medical sheet as described in claim 8, wherein, When the needle is heated after passing through the sheet component to form the through hole, or when the heated needle passes through the sheet component, the needle is heated to a temperature above the melting temperature of the fiber.

10. The method for manufacturing a medical sheet as described in claim 8, wherein, When the needle is heated after passing through the sheet component to form the through hole, or when the heated needle passes through the sheet component, the needle is heated to above the melting point of the fiber.

11. The method for manufacturing a medical sheet as described in claim 8, wherein, When the needle is heated after passing through the sheet component to form the through hole, and the planar base on which the needle is located is in contact with the sheet component, the needle is heated by heating the base, thereby forming the fusion portion.

12. The method for manufacturing a medical sheet as described in claim 8, wherein, When the needle is heated after penetrating the sheet component to form the through hole, or when the heated needle is penetrating the sheet component, the penetration of the needle is performed while multiple sheets of the sheet component are overlapped. Heating the needle is performed by maintaining the needle at a specified temperature for a specified time.

13. The method for manufacturing a medical sheet as described in claim 8, wherein, Before the needle penetrates the sheet component, the fibers of the plurality of sheet components are needle-punched, causing the fibers of the plurality of sheet components to become intertwined with each other compared to before the needle-punching.

14. The method for manufacturing a medical sheet as described in claim 8, wherein, After heating the needle, the sheet component is cooled. Remove the needle from the sheet component.

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