Fixed structure

Abstract

To provide a fixing structure that prevents bacterial infiltration and can suppress positional deviation from the target area.SOLUTION: A fixing structure 1 comprises: a porous sheet body 2 that is composed of a biocompatible, nonabsorbable material; a cylindrical insertion part 4 that guides an insertion member from the interior of a living body to the exterior; a holding part 5 that holds the area surrounding the opening of the sheet body 2 along the thickness direction of the sheet body 2 and is fixed to the insertion part 4; and a fixed thread-shaped body 33 that is composed of a thread-shaped body, sewed onto the sheet body 2 so as to fix the sheet body 2 and the holding part 5. The fixed thread-shaped body 33 is sewn onto the surface of the sheet body 2 so as to form a relief structure. This structure resists relative movement to the target area of the living body which the insertion member is inserted into, along the extension direction of the sheet body 2.SELECTED DRAWING: Figure 16

Description

Technical Field

[0006] , ,

[0005] , , ,

[0001] The present invention relates to a fixing structure.

Background Art

[0002] When leading an insertion member such as a medical tube or a drive line from inside the body to outside the body, a skin button, a cuff member, or the like is used as a fixture for fixing the insertion member to the skin.

[0003] As such a fixture, for example, Patent Document 1 discloses a medical tube fixture having a cylindrical portion into which a medical tube is inserted, a flange portion fixed at the percutaneous portion, and a fixing nut for fixing the flange portion to the cylindrical portion.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] A fixture such as that in Patent Document 1 fixes the flange portion to the cylindrical portion by sandwiching the flange portion with a flange retainer and a fixing nut. When the flange portion is made of a flexible material such as PTFE, the flange portion flexes due to the tightening of the fixing nut, and a gap occurs between the flange retainer and the fixing nut. Therefore, measures are required to prevent bacteria from entering through the gap, making handling difficult.

[0006] Also, although the flange portion is fixed to the skin by tissue invading the flange portion, it takes time until the flange portion is completely fixed to the skin. Therefore, if the flange portion moves relative to the skin in the unfixed state before the flange portion is completely fixed to the skin, the healing will be delayed.

[0007] Therefore, the present invention aims to provide a fixing structure that can suppress bacterial invasion and prevent displacement of the target site. [Means for solving the problem]

[0008] The fixing structure of the present invention comprises a porous sheet body made of a biocompatible, non-absorbable material having an opening through which an insertion member to be led out of a living body can be inserted; a cylindrical insertion portion having an insertion passage for guiding the insertion member from the living body to the living body; a clamping portion that clamps the portion of the sheet body around the opening in the thickness direction of the sheet body and is fixed to the insertion portion; and a fixing thread-like body made of a thread-like body sewn to the sheet body to fix the sheet body and the clamping portion, wherein the fixing thread-like body is sewn to the surface of the sheet body such that it forms an uneven structure that resists the relative movement of the insertion member with respect to the target part of the living body through which the insertion member is inserted in the extending direction of the sheet body. [Effects of the Invention]

[0009] According to the fixation structure of the present invention, bacterial invasion can be suppressed, displacement of the target site can be suppressed, and early fixation to the target site can be achieved. [Brief explanation of the drawing]

[0010] [Figure 1] This is a cross-sectional view showing a fixed structure of one embodiment of the present invention embedded in a wall-like tissue. [Figure 2] This figure shows one side of the fixed structure of one embodiment of the present invention. [Figure 3] This figure shows the other side of the fixed structure of one embodiment of the present invention. [Figure 4] Figure 2 is a schematic diagram of the section along line IV-IV. [Figure 5] This is a schematic diagram showing an enlarged view of region A1 in Figure 4. [Figure 6] This is a schematic diagram showing an enlarged view of area A2 in Figure 4. [Figure 7]This is an image of a cross-section of the fixing structure of the present embodiment that has been embedded and removed together with the skin after a predetermined period of time has elapsed. [Figure 8] This is an image of a cross-section of the fixing structure of the comparative example that has been embedded and removed together with the skin after a predetermined period of time has elapsed. [Figure 9] This is a schematic diagram showing the sewing pattern of the fixing structure of the second embodiment. [Figure 10] This is a schematic diagram showing the sewing pattern of the fixing structure of the third embodiment. [Figure 11] This is a schematic diagram showing the sewing pattern of the fixing structure of the fourth embodiment. [Figure 12] This is a schematic diagram showing the sewing pattern of the fixing structure of the fifth embodiment. [Figure 13] This is a perspective view showing the fixing structure of the sixth embodiment before the filament is sewn. [Figure 14] This is a cross-sectional view taken along line XIV-XIV of FIG. 13. [Figure 15] This is an exploded view showing the fixing structure of the sixth embodiment in a simplified manner. [Figure 16] This is a schematic diagram showing the state in which each member of the fixing structure is assembled to each other and the filament is sewn from the state shown in FIG. 15. [Figure 17] This is an enlarged view of the portion of the fixing structure of FIG. 16 where the filament is sewn. [Figure 18] This is a view showing the state in which the clamping portion is attached to the sheet body in the sixth embodiment. [Figure 19] This is a plan view showing the first clamping member of the clamping portion in the sixth embodiment. [Figure 20] This is a plan view of the sheet body in the sixth embodiment. [Figure 21] This is a photograph showing the state in which the filament on the sheet body side is sewn to the sheet body in the sixth embodiment. [Figure 22] This is a plan view showing the second clamping member of the clamping portion in the sixth embodiment. [Figure 23]It is a schematic diagram showing an example of a sewing pattern in which a fixing filament and a filament on the sheet body side are sewn together in a simplified manner. [Figure 24] It is a schematic diagram showing a sewing pattern of the filament on the sheet body side in the fixing structure of the seventh embodiment. [Figure 25] It is a schematic diagram showing a modified example of the fixing structure of the seventh embodiment. [Figure 26] It is a schematic diagram showing a sewing pattern of the filament on the sheet body side in the fixing structure of the eighth embodiment. [Figure 27] It is a diagram schematically showing the overlap between the filament on the sheet body side and the fixing filament in the fixing structure of the eighth embodiment. [Figure 28] It is a schematic diagram showing a sewing pattern of the filament on the sheet body side in the fixing structure of the ninth embodiment.

Embodiments for Carrying Out the Invention

[0011] <First Embodiment> Hereinafter, with reference to the drawings, the fixing structure of an embodiment of the present invention will be described. Note that the embodiments shown below are merely examples, and the fixing structure of the present invention is not limited to the following embodiments.

[0012] In this specification, expressions such as "perpendicular to A" and similar expressions do not refer only to the direction completely perpendicular to A, but include the direction substantially perpendicular to A. Also, in this specification, expressions such as "parallel to B" and similar expressions do not refer only to the direction completely parallel to B, but include the direction substantially parallel to B. Further, in this specification, expressions such as "C shape" and similar expressions do not refer only to the complete C shape, but include a shape that reminds one of the C shape visually (substantially C shape).

[0013] As shown in Figure 1, the fixing structure 1 of this embodiment is used to fix an insertion member IS, which is led out of the body from inside to outside, to a wall-like tissue T of the body. As shown in Figure 1, the fixing structure 1 is fixed to the wall-like tissue T of the body by being embedded at a predetermined position and depth in the wall-like tissue T of the body with the insertion member IS inserted through it. The use of the fixing structure 1 is not particularly limited as long as it is used to fix an insertion member IS, which is led out of the body from inside to outside, to a wall-like tissue T of the body. For example, the fixing structure 1 can be used in a skin button (cuff member) through which the insertion member IS is inserted.

[0014] In this specification, "living organism" refers to the body of a human or other animal. "Wall-like tissue" refers to any wall, membrane, or other tissue of a living organism having a predetermined thickness through which the insertion member IS is inserted. Specifically, wall-like tissue refers to various tissues within a living organism, such as skin (epidermis, dermis, subcutaneous tissue), muscle layer, and tissues constituting various organs, as well as layers formed by combinations of these. In this embodiment, the wall-like tissue T through which the insertion member IS is inserted is a tissue including skin (epidermis, dermis, subcutaneous tissue) and muscle layer. The fixation position (implantation position) in the wall-like tissue T to which the fixation structure 1 is fixed can be appropriately changed according to the body shape of the patient (living organism) to which the fixation structure 1 is fixed.

[0015] The use of the fixing structure 1 is not particularly limited, as long as it fixes the insertion member IS, which is led out of the body from inside to outside, to the wall-like tissue T of the body. In this embodiment, the fixing structure 1 is used when inserting a driveline (insertion member IS) used in a medical device implanted in the human body (for example, an artificial organ such as an artificial heart assist device (VAD) or artificial lung) into the wall-like tissue T of the abdomen, and leading the driveline out of the body. As shown in Figure 1, the driveline led out of the body is fixed at a predetermined position in the abdomen via the fixing structure 1.

[0016] The insertion member IS is a linear member having a predetermined length and inserted into a wall-like tissue T of a living body. The term "linear" in relation to the insertion member IS means that it extends for a predetermined length, regardless of whether the insertion member IS is hollow or solid. In this embodiment, the insertion member IS is a long medical member positioned to penetrate the wall-like tissue T of a living body. More specifically, the insertion member IS is a driveline for an artificial organ (artificial heart assist device). One end of the insertion member IS is connected to an artificial organ (not shown) located at a predetermined position inside the body, and the other end is connected to equipment (such as a power supply) located outside the body.

[0017] The internal structure of the insertion member IS is not particularly limited, but for example, the insertion member IS has a cooling water circulation passage for circulating cooling water between an artificial organ inside the body and a pressure pump outside the body, and a power cable for connecting the artificial organ inside the body and a power source outside the body. The insertion member IS may also have a configuration that has only a power cable, or a configuration that has only a cooling water circulation passage. Furthermore, the insertion member IS may have a configuration that has other components with functions other than those described above, or it may be configured as a hollow component (tube) without any components inside. When the insertion member IS is used as a hollow component that connects the inside and outside of the body, it may be used to deliver medicine from outside the body to a treatment site inside the body for therapeutic purposes.

[0018] When inserting the insertion member IS into the wall-shaped tissue T, for example, as shown in Figure 1, the fixing structure 1 is fixed to the wall-shaped tissue T with the insertion member IS inserted into the fixing structure 1. More specifically, the fixing device D shown in Figure 1 is used to fix the insertion member IS to the wall-shaped tissue T with the insertion member IS inserted into the wall-shaped tissue T. The fixing structure 1 (fixing device D) of this embodiment includes a connecting member C that (indirectly) connects the insertion member IS to the sheet body 2. In this embodiment, the connecting member C includes a first connecting member C1 and a second connecting member C2 that sandwich the sheet body 2, which will be described later, in the thickness direction of the sheet body 2. The first connecting member C1 and the second connecting member C2 are configured to allow the insertion member IS to be inserted. In this embodiment, at least one of the first connecting member C1 and the second connecting member C2 (in this embodiment, the first connecting member C1) is inserted into the opening 21 of the sheet body 2. The insertion member IS is inserted through the first connecting member C1 and the second connecting member C2, which are then screwed together, so that the portion of the sheet body 2 around the opening 21 is sandwiched between the first connecting member C1 and the second connecting member C2. In this way, the fixing structure 1 and the insertion member IS are connected via the connecting member C. In this state, as shown in Figure 1, the fixing structure 1 is embedded in the wall-like tissue T, thereby fixing the insertion member IS in a predetermined position with the insertion member IS inserted into the wall-like tissue T via the fixing structure 1. Note that the method of connection between the connecting member C and the sheet body 2 is not limited to the method described above. Furthermore, the structure of the fixing structure 1 is not limited to the structure using the connecting member C shown in Figure 2, as long as it can support the insertion member IS in the inserted state. For example, the fixing structure 1 may include a cylindrical insertion part 4 and a clamping part 5, as shown in Figure 16, and the insertion part 4 and the clamping part 5 may be fixed by a fixing thread-like body 33.

[0019] As shown in Figures 1 to 3, the fixing structure 1 has an opening 21 through which an insertion member IS, which is led out of the body from inside to outside the body, can be inserted, and has a porous sheet body 2 made of a biocompatible, non-absorbable material.

[0020] The sheet body 2 is the portion embedded in the wall-like tissue T when the fixing structure 1 is fixed (attached) to the wall-like tissue T with the insertion member IS inserted into the wall-like tissue T. For example, the sheet body 2 is embedded in the wall-like tissue T so as to slip under a part of the wall-like tissue T (e.g., skin) that has been incised to insert the insertion member IS. As a result, the sheet body 2 is fixed to a predetermined location in the wall-like tissue T, as shown in Figure 1.

[0021] The sheet body 2 is composed of a biocompatible, non-absorbable material. The biocompatible, non-absorbable material constituting the sheet body 2 can be the same material used as medical sheets in the body or on wounds. Furthermore, it is preferable that the sheet body 2 is composed of a flexible material before the thread-like material 3, described later, is sewn onto it. The material constituting the sheet body 2 can be, for example, at least one selected from the group consisting of polyurethane resin, polyamide resin, polylactic acid resin, polyolefin resin, polyester resin, fluororesin, urea resin, phenolic resin, epoxy resin, polyimide resin, acrylic resin, and methacrylic resin, and their derivatives, and preferably, stretched polytetrafluoroethylene (ePTFE).

[0022] Furthermore, it is preferable that the sheet body 2 is made of a porous sheet in order to promote the growth and attachment of cells from the wall-like tissue T to the sheet body 2. The pore size (average pore size) of the porous sheet body 2 is not particularly limited, as long as it is of a size that facilitates cell growth and attachment when the sheet body 2 is embedded in the wall-like tissue T. The average pore size of the sheet body 2 can be, for example, 10 to 100 μm.

[0023] The shape of the sheet body 2 is not particularly limited, as long as it is a shape that allows the insertion member IS to be inserted and is suitable for embedding in a wall-like tissue T. In this embodiment, the sheet body 2 is formed in a circular (approximately circular) shape with an opening 21 in the central part, but it may be formed in a shape other than circular, such as an ellipse or polygon. The size of the sheet body 2 is not particularly limited and can be appropriately changed depending on the diameter of the insertion member IS inserted into the sheet body 2, and the use and fixing location of the fixing structure 1. The sheet body 2 can be, for example, the same size as the flange portion of a known skin button (cuff member) that is embedded in a wall-like tissue T. If the sheet body 2 is circular, the diameter of the sheet body 2 can be, for example, 5 to 80 mm. The thickness of the sheet body 2 is not particularly limited, but can be, for example, 0.5 to 5 mm. Also, if the sheet body 2 is elliptical or otherwise has different dimensions in the longitudinal direction and the transverse direction, the longitudinal dimension of the sheet body 2 can be 10 mm to 80 mm. For example, if the sheet body 2 is elliptical in shape, the major axis of the sheet body 2 can be set to 40-80 mm and the minor axis to 20-40 mm.

[0024] The opening 21 provided in the sheet body 2 is located in the central part of the sheet body 2 and penetrates through the sheet body 2 in the thickness direction. The size of the opening 21 is appropriately set to a size that allows the insertion member IS to be inserted. In this embodiment, the opening 21 is provided to a size that allows the connecting member C (see Figure 1) to be inserted (with the thread-like body described later provided). In this specification, a predetermined region of the sheet body 2 in the direction from the opening edge 21a of the opening 21 toward the outer peripheral edge 22 of the sheet body 2 (in this embodiment, the radially outer side of the sheet body 2) is called the central region Ra (see Figure 2). Also, a predetermined region of the sheet body 2 around the outer peripheral edge 22 of the sheet body 2, that is, in the direction from the outer peripheral edge 22 of the sheet body 2 toward the opening 21 (in this embodiment, the radially inner side of the sheet body 2) is called the peripheral region Rb (see Figure 2). Furthermore, the region between the central region Ra and the peripheral region Rb is called the intermediate region Rc (see Figure 2). The range of the central region Ra of the sheet body 2 is not particularly limited, but for example, it can be the region from the opening edge 21a of the sheet body 2 to 30-60% of the radial distance between the opening edge 21a and the outer edge 22 of the sheet body 2. Similarly, the range of the peripheral region Rb of the sheet body 2 is not particularly limited, but it can be the region from the outer edge 22 of the sheet body 2 to 20-60% of the radial distance between the opening edge 21a and the outer edge 22 of the sheet body 2. Preferably, the range of the central region Ra and the intermediate region Rc can be the region from the opening edge 21a of the sheet body 2 to 50% of the radial distance between the opening edge 21a and the outer edge 22 of the sheet body 2.

[0025] Furthermore, as will be described later, the sheet body 2 has (multiple) through holes 23 (see Figure 6) that penetrate the thickness direction of the sheet body 2 for inserting the thread-like material 3. These through holes 23 are formed in predetermined positions according to a predetermined uneven structure (formed by the thread-like material 3) that will be formed on the sheet body 2, as will be described later, before the thread-like material 3 is sewn in. Because the through holes 23 are provided in predetermined positions on the sheet body 2 before the thread-like material 3 is sewn in, the through holes 23 serve as markers indicating where the thread-like material 3 should be sewn, making it easy to form the uneven structure with the thread-like material 3. In this embodiment, four through holes 23 are provided in the radial direction and arranged in a circumferential direction, but the number and arrangement of the through holes 23 can be appropriately changed depending on the sewing pattern.

[0026] The size of the through-hole 23 through which the filamentous body 3 is inserted is not particularly limited, as long as it is possible to insert the filamentous body 3. In this embodiment, the through-hole 23 is formed such that the clearance CL (see Figure 6) between the inner circumference of the portion of the sheet body 2 in which the through-hole 23 is formed and the filamentous body 3 is 1 mm or less, preferably 100 μm to 300 μm. In this case, not only the gap between the filamentous body 3 and the surface of the sheet body 2, as described later, but also the clearance CL between the filamentous body 3 and the through-hole 23 of the sheet body 2 makes it easier for body fluids and cells to flow toward the epidermis, and makes it easier for the cells of the wall-like tissue T to grow and settle. The above clearance CL can be the maximum gap between the inner circumference (inner surface) of the portion of the sheet body 2 in which the through-hole 23 is formed and the outer circumference of the filamentous body 3 in the extending direction of the surface of the sheet body 2. Furthermore, multiple thread-like bodies 3 may be inserted through a single through-hole 23 from one surface 2a (see Figure 4) to the other surface 2b (see Figure 4) of the sheet body 2, or from the other surface 2b to the one surface 2a, either multiple times or with multiple threads. In this case, the clearance CL is the maximum gap between the inner circumference (opening edge) of the portion of the sheet body 2 where the through-hole 23 is formed and the outer circumference of the thread-like body 3, when the thread-like bodies 3 have been passed through multiple times or with multiple threads.

[0027] The fixing structure 1 includes thread-like bodies 3 sewn onto the surface of the sheet body 2, as shown in Figures 1 to 6. The thread-like bodies 3 form an uneven structure on the sheet body 2 that resists relative movement of the sheet body 2 with respect to the target site of the living body through which the insertion member IS is inserted, in the direction of extension of the sheet body 2. Here, the target site of the living body is the peripheral portion of the wall-like tissue T to which the insertion member IS is inserted. More specifically, the target site of the living body is the portion of the wall-like tissue T that has been incised to install the fixing structure 1 through which the insertion member IS is inserted. In this specification, the term "thread-like body" is not limited to thread-like bodies sewn only to the sheet body 2 (such as the radial suture portion 31, circumferential suture portion 32, and sheet body side thread-like body 34 described later), as long as it can form an uneven structure that resists relative movement of the sheet body 2 with respect to the target site, in the direction of extension of the sheet body 2. For example, the "thread-like body" also includes a fixing thread-like body 33 that fixes the sheet body 2 to other members (for example, the clamping part 5 described later).

[0028] The uneven structure, composed of filamentous bodies 3, which resists relative movement of the sheet body 2 with respect to the target area in the direction of its extension, suppresses relative movement between the sheet body 2 and the target area (wall-like tissue T; hereinafter, the target area will also be referred to as wall-like tissue T) in any direction perpendicular to the thickness direction of the sheet body 2, i.e., the direction in which the sheet body 2 extends. The uneven structure is provided by having the filamentous bodies 3 sewn onto the surface of the sheet body 2 (one surface 2a and / or the other surface 2b in the thickness direction) in a predetermined pattern, so that the filamentous bodies 3 protrude from the surface of the sheet body 2 in the thickness direction (see Figures 1 and 4). More specifically, the parts of the sheet body 2 to which the filamentous bodies 3 are sewn constitute the convex parts of the uneven structure, and the parts where the filamentous bodies 3 are not provided, i.e., the surface of the sheet body 2, constitute the concave parts of the uneven structure.

[0029] As described above, in this embodiment, the fixing structure 1 has thread-like bodies 3 sewn onto the surface of the sheet body 2 so as to form an uneven structure that resists relative movement of the sheet body 2 with respect to the target area in the extending direction of the sheet body 2. As a result, when the fixing structure 1 is placed on the target area (wall-like tissue T), a part of the wall-like tissue T fits into the recesses of the uneven structure. Furthermore, in the fixing structure 1 of this embodiment, the contact area with the wall-like tissue T is larger compared to a fixing structure consisting only of a sheet body without thread-like bodies, so the uneven structure of the fixing structure 1 also increases the resistance when the fixing structure 1 moves relative to the wall-like tissue T. Therefore, relative movement between the sheet body 2 and the wall-like tissue T in the extending direction of the sheet body 2 parallel to the surface of the sheet body 2 (in this embodiment, the radial and circumferential directions of the sheet body 2) is suppressed (the sheet body 2 moves relative to the wall-like tissue T, or the wall-like tissue T moves relative to the sheet body 2). Therefore, displacement relative to the target area can be suppressed without suturing the sheet body 2 to the target area such as skin. Therefore, the fixation structure 1 can be fixed to the target site early with a simple procedure. More specifically, the uneven structure formed by the filamentous bodies 3 prevents the fixation structure 1 from shifting relative to the wall-like tissue T of the living body. Consequently, the cells of the wall-like tissue T can stably proliferate and enter the sheet body 2, promoting healing of the incision site (target site) through which the insertion member IS is inserted.

[0030] Furthermore, because the filamentous bodies 3 are sutured to the sheet body 2, a minute space SP (in Figure 5, the size of the space SP is exaggerated for ease of understanding) is formed between the filamentous bodies 3 and the sheet body 2 in the thickness direction of the sheet body 2, as shown in Figure 5. When the fixation structure 1 is embedded in the wall-like tissue T and a predetermined period of time has elapsed, cells from the wall-like tissue T enter this minute space SP. This promotes healing at the incision site of the wall-like tissue T and enables early fixation of the fixation structure 1 to the wall-like tissue T. In addition, as cells from the wall-like tissue T enter this minute space SP, the filamentous bodies 3 are constrained by the entered cells. Therefore, even if the entire fixation structure 1 attempts to move relative to the wall-like tissue T, the cells that have entered the minute space SP become entangled with the filamentous bodies 3, suppressing the relative movement of the fixation structure 1 relative to the wall-like tissue T.

[0031] Figure 7 shows a hematoxylin-eosin stained (HE stain) image of a cross-section of a rat's back after it had been removed from the back along with the skin following a 30-day incision in the rat's back. The fixed structure 1, consisting of an ePTFE sheet 2 with filamentous bodies 3 sutured to it, was embedded under the skin. As shown in Figure 7, it was observed that cells of wall-like tissue T had entered between the filamentous bodies 3 and the sheet 2, and between the filamentous bodies 3 themselves, making it difficult for the skin to peel off. Furthermore, cells that had entered the gap between the filamentous bodies 3 and the surface of the sheet 2 were tightly attached to the surface of the sheet 2, confirming that cells had entered the porous surface of the sheet 2 (the surface of the sheet 2 is slightly discolored in the image in Figure 7). On the other hand, Figure 8 shows a hematoxylin-eosin stained (HE stained) image of a cross-section of a comparative example, magnified 40 times, after implantation under the same conditions as in Figure 7, except that the fixation structure of the comparative example was not sutured to the filamentous bodies 3. The fixation structure of the comparative example was removed from the back, including the skin, and the resulting section was removed. In the comparative example in Figure 8, a porous ePTFE sheet similar to the image in Figure 7 was used, but the wall-like tissue T had peeled away from the surface of the sheet 2, creating a gap, and cell invasion into the surface of the sheet 2 could not be confirmed. Thus, it was found that by suturing the filamentous bodies 3 to the sheet 2, cells from the wall-like tissue T could enter the minute space SP between the filamentous bodies 3 and the sheet 2, promoting healing of the incision site and enabling early fixation between the fixation structure 1 and the wall-like tissue T.

[0032] The uneven structure only needs to be provided on at least one surface of the sheet body 2, but in this embodiment, the uneven structure is provided on both surfaces of the sheet body 2. When the uneven structure is provided on both surfaces of the sheet body 2, relative movement between the fixing structure 1 and the wall-like tissue T can be suppressed more effectively, making it easier for cells of the wall-like tissue T to invade both one surface 2a and the other surface 2b of the sheet body 2, and further promoting the healing of the incision site.

[0033] The filamentous body 3, like the sheet body 2, is composed of a biocompatible, non-absorbable material. The biocompatible, non-absorbable material constituting the filamentous body 3 can be the same material used for medical sutures. The material constituting the filamentous body 3 can be at least one selected from the group consisting of polyurethane resin, polyamide resin, polylactic acid resin, polyolefin resin, polyester resin, fluororesin, urea resin, phenolic resin, epoxy resin, polyimide resin, acrylic resin, and methacrylic resin, and their derivatives, and preferably stretched polytetrafluoroethylene (ePTFE). Furthermore, the filamentous body 3 is preferably porous in order to promote the growth and establishment of cells in the more wall-like tissue T.

[0034] The thickness of the filamentous material 3 is not particularly limited as long as it can form an uneven structure that resists relative movement with respect to the target area in the extending direction of the sheet body 2. For example, a thread with a diameter of 0.1 to 0.5 mm, preferably 0.1 to 0.3 mm, and more preferably 0.2 mm can be used.

[0035] The thread-like material 3 is sewn to the sheet body 2 using a predetermined sewing pattern, which will be described later. The sewing pattern of the thread-like material 3 is not particularly limited as long as it can form an uneven structure that resists relative movement of the target area in the extending direction of the sheet body 2. The thread-like material 3 may be sewn continuously by a single thread-like material 3 as the entire sewing pattern, or it may be sewn in sections by multiple thread-like material 3. Furthermore, as shown in Figures 2 and 3, one surface 2a and the other surface 2b may be sewn with the same sewing pattern, or one surface 2a and the other surface 2b may be sewn with different sewing patterns.

[0036] Next, the sewing pattern of the thread-like material 3 in this embodiment will be described.

[0037] In this embodiment, the thread-like body 3 has a plurality of radial suture portions 31 that extend radially in a direction connecting the opening 21 and the outer peripheral edge 22 of the sheet body 2, as shown in Figures 2 and 3. The thread-like body 3 also has circumferential suture portions 32 that extend in the circumferential direction of the sheet body 2.

[0038] The radial suture portion 31 is part of the sewing pattern of the thread-like body 3, extending radially. Here, "extending radially" means that the thread-like body 3 extends in the direction connecting the opening 21 and the outer edge 22 (hereinafter referred to as the radial direction). In this embodiment, the radial suture portion 31 extends in the radial direction of the circular sheet body 2. The radial suture portion 31 may be inclined with respect to the radial direction of the sheet body 2, as long as it extends in the direction connecting the opening 21 and the outer edge 22 so as to radiate from the opening 21. In addition, in this embodiment, the radial suture portion 31 extends radially from the opening edge 21a of the sheet body 2, but it does not necessarily have to extend from the opening edge 21a, and may extend toward the outer edge 22 (radially outward) from a position closer to the outer edge 22 than the opening edge 21a. In this embodiment, as shown in Figures 2 and 3, the radial suture portion 31 extends radially to a length that does not reach the outer edge 22 from the opening 21, and as will be described later, the sheet body 2 has an unsutured portion 24 to which the thread-like body 3 is not sewn.

[0039] The radial suture portion 31 constitutes part of the uneven structure and extends radially, thereby suppressing relative movement between the fixing structure 1 and the wall-like tissue T in directions intersecting the radial direction. In this embodiment, the radial suture portion 31 is composed of multiple radial suture portions 311 and 312 that extend radially from the opening edge 21a at predetermined angular intervals. The multiple radial suture portions 311 and 312 are provided over the entire circumferential direction of the opening edge 21a. When multiple radial suture portions 311 and 312 extending radially are provided, relative movement of the fixing structure 1 with respect to the wall-like tissue T can be suppressed even if forces are applied to the fixing structure 1 in various directions. Furthermore, even if a force is applied to the fixing structure 1 in a direction that rotates it in the circumferential direction of the sheet body 2 (around the axis of the insertion member IS) relative to the wall-like tissue T, each radial suture portion 311 and 312 acts as resistance, suppressing the rotation of the fixing structure 1. In this embodiment, the multiple radial sutures 311 and 312 extending in multiple radial directions are provided at different lengths, but the multiple radial sutures extending in multiple radial directions may be of the same length.

[0040] As described above, the radial suture portion 31 may have a plurality of radial suture portions 311, 312 of different lengths. As will be described in detail later, in this embodiment, the radial suture portion 31 has a plurality of first radial suture portions 311 extending radially from the opening 21 for a predetermined length, and a plurality of second radial suture portions 312 extending radially from the opening 21 for a length shorter than the length of the first radial suture portions 311, as shown in Figures 2 and 3. The radial suture portion 31 may also have other radial suture portions (for example, a third radial suture portion, a fourth radial suture portion, etc.) of different lengths from the first radial suture portions 311 and the second radial suture portions 312.

[0041] Furthermore, as shown in Figures 2 and 3, some of the multiple radial sutures 31 may be adjacent to each other in the circumferential direction and extend parallel to each other in the radial direction 1. In this case, a space is formed between the adjacent radial sutures 31. When cells of the wall-like tissue T enter this space, the cells that enter the space become entangled with the filaments 3, further suppressing the relative movement of the fixed structure 1 with respect to the wall-like tissue T.

[0042] The circumferential suture portion 32 is part of the stitching pattern of the thread-like body 3 that extends in the circumferential direction. Here, "extending in the circumferential direction" means extending in substantially the same direction as the direction along the outer peripheral edge 22 or the opening edge 21a of the sheet body 2. In this embodiment, the circumferential suture portion 32 extends in a direction intersecting the radial direction (the radial direction of the sheet body 2). More specifically, the circumferential suture portion 32 extends so as to connect one radial suture portion 31 (first radial suture portion 311) and another radial suture portion 31 (first radial suture portion 311) at the same radial position.

[0043] In this embodiment, the circumferential suture portion 32 extends so as to intersect with the radial suture portion 31 (extending so as to connect the ends of the first radial suture portion 311 on the outer peripheral edge 22 side). However, the circumferential suture portion 32 does not necessarily have to intersect with the radial suture portion 31. Also, in this embodiment, the circumferential suture portion 32 is provided so as to be continuous in the circumferential direction and to make one full turn around the axis of the insertion member IS inserted through the opening 21. However, the circumferential suture portion 32 does not have to be provided continuously in the circumferential direction, and may be interrupted and provided intermittently in the circumferential direction.

[0044] The circumferential suture portion 32 constitutes part of the uneven structure and extends in the circumferential direction, thereby suppressing relative movement between the fixing structure 1 and the wall-like tissue T in a direction that intersects the circumferential direction. By suppressing relative movement in a direction that intersects the circumferential direction, the fixing structure 1 embedded in the wall-like tissue T is prevented from detaching from the wall-like tissue T. For example, when the insertion member IS is pulled upward in Figure 1, the fixing structure 1 receives a force such that the central part near the opening 21 is pulled upward. In this case, the part of the fixing structure 1 to the right of the insertion member IS in Figure 1 receives a force that tries to move it to the left, and the part to the left of the insertion member IS receives a force that tries to move it to the right. The circumferential suture portion 32 resists this force by catching on the wall-like tissue T, thereby suppressing displacement of the fixing structure 1 and detachment from the wall-like tissue T. Furthermore, because the circumferential suture portion 32 extends continuously in the circumferential direction, it is possible to suppress the bending of the sheet body 2, which has a fold line in a direction intersecting the circumferential direction.

[0045] Furthermore, in this embodiment, as shown in Figures 2 and 3, the sheet body 2 has a non-suture portion 24 in a peripheral region Rb having a predetermined width from the outer peripheral edge 22 of the sheet body 2, to which the thread-like body 3 is not sewn. The non-suture portion 24 is a part where neither the radial suture portion 31 nor the circumferential suture portion 32 is provided, and is a part composed solely of the sheet body 2. Because the sheet body 2 has a non-suture portion 24, the peripheral region Rb of the fixing structure 1 is flexible relative to the central region Ra. Therefore, when the fixing structure 1 is embedded in a wall-like tissue T, it can follow the movement of the wall-like tissue T, such as skin.

[0046] Furthermore, in this embodiment, the filamentous bodies 3 are sewn to the sheet body 2 so that they become denser towards the outer edge 22 (peripheral region Rb) of the sheet body 2, starting from the central region Ra side around the opening 21 of the sheet body 2. In this case, the filamentous bodies 3 (particularly the radial suture portion 31 in this embodiment) become denser in the central region Ra, increasing the rigidity of the central region Ra of the fixing structure 1, and making the fixing structure 1 less susceptible to deformation in the central region Ra. As a result, even if a force is applied from the insertion member IS inserted into the fixing structure 1 that deforms the part of the fixing structure 1 around the opening 21 due to the weight of the insertion member IS, the deformation of the fixing structure 1 is suppressed. Therefore, the insertion member IS inserted into the fixing structure 1 can be maintained at a predetermined angle with respect to the target site (wall-like tissue T). Consequently, deformation of the fixing structure 1 or tilting relative to the wall-like tissue T prevents cells that have grown between the fixing structure 1 and the wall-like tissue T from detaching. Therefore, cell growth is not inhibited, cell proliferation in the central region Ra becomes active, promoting healing of the incision site and suppressing downgrowth.

[0047] Furthermore, the filamentous bodies 3 become coarser on the peripheral region Rb side of the sheet body 2, allowing the fixation structure 1 (sheet body 2) to conform to the movement and shape of the target area such as the skin. Therefore, patients who have the fixation structure 1 implanted can reduce the discomfort they experience when the fixation structure 1 is implanted. Note that "from dense to coarse from the central region Ra side towards the outer peripheral edge 22 side of the sheet body 2" means that the amount of filamentous bodies 3 per unit area in the entire predetermined region on the central region Ra side (in Figure 2, the entire region within the central region Ra) is greater than the amount per unit area in the entire predetermined region on the outer peripheral edge 22 side (in Figure 2, the entire intermediate region Rc or the entire peripheral region Rb). Therefore, the statement "from the central region Ra side toward the outer edge 22 side of the sheet body 2, the density becomes denser" refers to a comparison between predetermined regions having a predetermined width in the radial direction. Even if there are areas where the density of filamentous bodies 3 (the ratio of filamentous bodies 3 per unit area of ​​the fixed structure 1) is locally higher as one moves outward in the radial direction, it is sufficient if the density decreases when comparing each region individually.

[0048] The stitching pattern of the thread-like material 3 is not particularly limited, as long as the thread-like material 3 is sewn to the sheet body 2 so that the stitching becomes denser from the central region Ra side towards the outer edge 22 side. In this embodiment, the radial suture portion 31 has a first radial suture portion 311 and a second radial suture portion 312, and the outer edge end of the first radial suture portion 311 (hereinafter referred to as the outer end) is located radially outward from the outer end of the second radial suture portion 312. As a result, the first radial suture portion 311 protrudes radially from the second radial suture portion 312. Therefore, in the central region Ra, where both the first radial suture portion 311 and the second radial suture portion 312 are provided, the density of the radial suture portion 31 is higher than in the intermediate region Rc, where the second radial suture portion 312 is not provided. (Note that in this embodiment, a circumferential suture portion 32 is provided in the intermediate region Rc, but even including the circumferential suture portion 32, the central region Ra is denser than the intermediate region Rc.)

[0049] Furthermore, as shown in Figure 1, the central region Ra may be sandwiched between connecting members C, etc., in a predetermined area from the opening edge 21a of the opening 21. In such cases, the portion where the filamentous material 3 changes from dense to sparse only needs to be in the portion not sandwiched by connecting members C, etc.

[0050] Furthermore, it is preferable that the filamentous bodies 3 (especially the radial suture portion 31) gradually become denser from the central region Ra side towards the outer edge 22 side. "Gradually becoming denser from denser to coarser" means that there are two or more regions with different densities of filamentous bodies 3, but it is preferable that the filamentous bodies 3 have three or more regions with different densities arranged in stages.

[0051] When the filamentous bodies 3 are sutured in a gradual progression from dense to loose, the fixation structure 1 can easily follow the movement of the target area, such as the skin, from the central region Ra to the peripheral region Rb of the sheet body 2. As a result, the abrupt change in the rigidity of the sheet body 2 and the resulting localized stress are suppressed, preventing the sheet body 2 from bending and causing separation of the parts where the surface of the sheet body 2 and the cells of the wall-like tissue T were fixed, thereby preventing delays in the healing of the incision site.

[0052] Next, the fixing structure of other embodiments will be described. In the following description, explanations of matters common to the first embodiment described above will be omitted, and the focus will be on the differences. All matters described in the first embodiment can be applied to the fixing structure of the other embodiments described below, insofar as the objective of the invention is achieved, and the configurations of the other embodiments described below can be used in combination with the contents described in the first embodiment. Furthermore, the effects obtained by the configuration described in the first embodiment can also be obtained in the other embodiments described below, as long as that configuration is present. In addition, the configurations of the other embodiments described below can be combined.

[0053] <Second Embodiment> The fixing structure 1 of the second embodiment has a plurality of circumferential sutures 32, as shown in Figure 9. Specifically, the fixing structure 1 of the second embodiment has a plurality of (three in Figure 9) circumferential sutures 32 that are at different distances from the opening edge 21a in the radial direction. The fixing structure 1 of this embodiment does not have radial sutures and has a non-suture portion 24 in the peripheral region Rb that does not have filamentous bodies 3. In this embodiment, the provision of a plurality of circumferential sutures 32 further suppresses relative movement in the radial direction between the fixing structure 1 and the wall-like tissue T.

[0054] <Third Embodiment> The fixing structure 1 of the third embodiment, as shown in Figure 10, has multiple (three in Figure 10) circumferential suture portions 32 at different distances from the opening edge 21a in the radial direction, similar to the second embodiment. The fixing structure 1 of this embodiment has a non-suture portion 24 in the peripheral region Rb that does not have a thread-like body 3. In addition, this embodiment has multiple radial suture portions 31 provided in the central region Ra, extending radially toward the opening edge 21a from the circumferential suture portion 32 closest to the opening 21. Similar to the second embodiment, the fixing structure 1 of this embodiment has multiple circumferential suture portions 32, which further suppresses relative movement in the radial direction between the fixing structure 1 and the wall-like tissue T. In addition, the presence of multiple radial suture portions can suppress relative movement between the fixing structure 1 and the wall-like tissue T in directions intersecting the radial direction. Furthermore, since the multiple radial suture portions 31 are provided over the entire circumferential direction of the opening edge 21a, rotation of the fixing structure 1 relative to the wall-like tissue T can be suppressed. Furthermore, since the central region Ra side is dense and the outer edge 22 side of the sheet body 2 is loose, the rigidity of the central region Ra of the fixing structure 1 is increased, and the fixing structure 1 becomes less prone to deformation in the central region Ra. Therefore, as described above, the insertion member IS inserted through the fixing structure 1 can be maintained at a predetermined angle with respect to the target site (wall-like tissue T). Consequently, deformation of the fixing structure 1 or tilting with respect to the wall-like tissue T prevents cells that have grown between the fixing structure 1 and the wall-like tissue T from detaching. As a result, cell growth is not inhibited, cell proliferation in the central region Ra becomes active, healing of the incision site is promoted, and down-growth can be suppressed.

[0055] Furthermore, if the portion of the central region Ra around the opening 21 is sandwiched by a connecting member C or the like, as described above, the circumferential suture portion 32 and the radial suture portion 31 extending radially inward from the circumferential suture portion 32 can be positioned so as to be shifted radially toward the outer edge 22 side compared to the portion sandwiched by the connecting member C or the like.

[0056] <Fourth Embodiment> The fixing structure 1 of the fourth embodiment has a plurality of different radial sutures 31 extending from the central region Ra toward the outer peripheral edge 22, as shown in Figure 11. By having a plurality of radial sutures 31, relative movement between the fixing structure 1 and the wall-like tissue T in directions intersecting the radial direction can be suppressed. Furthermore, since the plurality of radial sutures 31 are provided over the entire circumferential direction of the opening edge 21a, rotation of the fixing structure 1 with respect to the wall-like tissue T can be suppressed. Note that in this embodiment, no circumferential sutures are provided. Note that the dashed line in Figure 11 indicates the boundary of the region of the fixing structure 1.

[0057] Furthermore, in this embodiment, the multiple different radial sutures 31 are sewn together such that the positions of the outer ends 311a, 312a, and 313a, which are the ends on the outer peripheral edge 22 side, are different from each other. In this embodiment, the positions of the outer ends 311a, 312a, and 313a of the radial sutures 31 extending from the central region Ra toward the outer peripheral edge 22 side are different from each other, so that the fixing structure 1 is configured to gradually become denser from the central region Ra side toward the outer peripheral edge 22 side.

[0058] Specifically, the fixing structure 1 of this embodiment comprises a plurality of first radial sutures 311, a plurality of second radial sutures 312, and a third radial suture 313 that extends further toward the outer peripheral edge 22 side (radially outward) of the sheet body 2 than the first radial sutures 311. More specifically, the first to third radial sutures 311, 312, and 313 are configured such that the outer end 312a of the second radial suture 312 is located furthest inward (towards the opening 21) in the radial direction, the outer end 313a of the third radial suture 313 is located furthest outward (towards the outer peripheral edge 22) in the radial direction, and the outer end 311a of the first radial suture 311 is located between the outer end 312a of the second radial suture 312 and the outer end 312a of the third radial suture 313 in the radial direction. As a result, in the fixing structure 1 of this embodiment, the density of the radial suture portion 31 is highest in the central region Ra, and the density of the radial suture portion 31 gradually becomes looser towards the outer edge 22. More specifically, in this embodiment, as shown in Figure 11, the fixing structure 1 has a first region (central region) Ra to which the first to third radial sutures 311, 312, and 313 are sewn and which has the highest density of radial sutures 31; a second region (first intermediate region) Rc1 adjacent to the outer edge 22 side of the first region Ra, to which the first and third radial sutures 311 and 313 are sewn and which has the next highest density after the first region Ra; a third region (second intermediate region) Rc2 adjacent to the outer edge 22 side of the second region Rc1, to which the third radial suture 313 is sewn and which has the next highest density after the second region Rc1; and a fourth region (peripheral region) Rb which is the coarsest, which is the unsutured region 24 to which the radial sutures 31 are not sewn. The number of different radial sutures 31 can be changed as appropriate; for example, there may be a fourth radial suture, a fifth radial suture, and so on.

[0059] As described above, the fixing structure 1 is configured to gradually become denser from the central region Ra towards the outer edge 22. This increases the rigidity of the central region Ra of the fixing structure 1, making it less susceptible to deformation in the central region Ra. Therefore, as described above, the insertion member IS inserted into the fixing structure 1 can be maintained at a predetermined angle with respect to the target area (wall-like tissue T). Consequently, deformation of the fixing structure 1 or tilting relative to the wall-like tissue T prevents cells that have grown between the fixing structure 1 and the wall-like tissue T from detaching. As a result, cell growth is not inhibited, cell proliferation in the central region Ra becomes more active, promoting healing of the incision site and suppressing downgrowth. Furthermore, in this embodiment, as described above, the thread-like bodies 3 are sewn in a manner that gradually becomes denser from the central region Ra to the outer edge Rb of the sheet body 2. In this case, the fixing structure 1 can easily follow the movement of the target area such as skin from the central region Ra to the peripheral region Rb of the sheet body 2. Therefore, the rapid change in the rigidity of the sheet body 2 and the resulting localized stress are suppressed, preventing the sheet body 2 from bending and causing the parts where the surface of the sheet body 2 and the cells of the wall-like tissue T were fixed to each other to detach, thus preventing delays in the healing of the incision site.

[0060] In this embodiment, the third radial suture portion 313 may extend to the opening edge 21a. Also, the area around the opening 21 of the central region Ra may be sandwiched by a connecting member C (see Figure 1), in which case the inner ends 311b and 312b of the first and second radial suture portions 311 and 312 may be on the outer peripheral edge 22 side with respect to the opening 21 (for example, at the same radial position as the inner end 313b of the third radial suture portion 313).

[0061] <Fifth Embodiment> The fixing structure 1 of the fifth embodiment further includes a circumferential suture portion 32 compared to the fixing structure 1 of the fourth embodiment. In the fifth embodiment, in addition to the effects described in the fourth embodiment, the circumferential suture portion 32 can suppress relative movement in the radial direction between the fixing structure 1 and the wall-like tissue T.

[0062] In this embodiment, the circumferential suture portion 32 extends circumferentially to connect the outer ends 313a of the multiple third radial suture portions 313, but the radial position of the circumferential suture portion 32 is not limited to the position shown in the figure. Furthermore, multiple circumferential suture portions 32 may be provided at multiple different radial positions, as shown in Figure 9.

[0063] Furthermore, as a further modification, the sheet body 2 used in any of the embodiments described above may be configured such that the flexibility of the sheet body 2 gradually increases from the central region Ra around the opening 21 of the sheet body 2 toward the outer peripheral edge 22 of the sheet body 2. In this case, the sheet body 2 can easily follow the movement of the target area such as skin from the central region Ra to the peripheral region Rb, and the abrupt change in the rigidity of the sheet body 2 and the application of localized stress are suppressed. Therefore, problems such as the sheet body 2 bending due to localized stress, causing the part where the surface of the sheet body 2 and the cells of the wall-like tissue T were fixed to separate, and delaying healing, are less likely to occur. Note that the configuration for gradually increasing the flexibility of the sheet body 2 from the central region Ra toward the outer peripheral edge 22 is not particularly limited, but for example, the flexibility of the sheet body 2 can be gradually increased from the central region Ra toward the outer peripheral edge 22 of the sheet body 2 by changing the thickness of the sheet body 2 toward the outer peripheral edge 22 of the sheet body 2, or by applying a coating to the sheet body 2.

[0064] <Sixth Embodiment> The fixing structure 1 of the sixth embodiment differs from the fixing structures of the first to fifth embodiments in that, as will be described later, it includes a cylindrical insertion portion 4 that guides the insertion member IS and a clamping portion 5 that clamps the sheet body 2 and is fixed to the insertion portion 4. The points described below can also be applied to the fixing structures of the first to fifth embodiments and the seventh to ninth embodiments.

[0065] Figure 13 is a perspective view showing the fixing structure of the sixth embodiment before the thread-like material is sewn on. Figure 14 is a cross-sectional view taken along line XIV-XIV of Figure 13. Figure 15 is a simplified exploded view showing the fixing structure of the sixth embodiment. Figure 16 is a schematic diagram showing the state in which each member of the fixing structure is assembled to each other and the thread-like material is sewn on, starting from the state shown in Figure 15. Figure 17 is an enlarged view of the part of the fixing structure of Figure 16 to which the thread-like material is sewn on. Note that Figures 15 to 17 show a conceptually simplified fixing structure, and the number of through holes, the shape of the insertion part, etc., do not match the fixing structure shown in Figure 14. Figure 18 is a diagram showing the state in which the clamping part is attached to the sheet body in the sixth embodiment. Figure 19 is a plan view showing the first clamping member of the clamping part in the sixth embodiment. Figure 20 is a plan view of the sheet body in the sixth embodiment. Figure 21 is a photograph showing the state in which the sheet body side thread-like material is sewn to the sheet body in the sixth embodiment. Figure 22 is a plan view showing the second clamping member of the clamping portion in the sixth embodiment. Figure 23 is a simplified schematic diagram showing an example of a sewing pattern in which the fixed thread-like body and the sheet-side thread-like body are sewn together.

[0066] As shown in Figures 13 to 18, the fixing structure 1 of this embodiment comprises a cylindrical insertion portion 4 having an insertion passage 41 that guides the insertion member IS (see Figure 14) from inside the body to outside the body, and a clamping portion 5 that clamps the portion around the opening of the sheet body 2 in the thickness direction of the sheet body 2 and is fixed to the insertion portion 4.

[0067] The insertion portion 4 supports the insertion member IS with respect to the living body while it is inserted through the insertion portion 4. The insertion portion 4 is connected to the sheet body 2, as will be described later. In this embodiment, the insertion portion 4 is connected to the sheet body 2 via the clamping portion 5.

[0068] The insertion portion 4 connects the inside and outside of the living body. In this embodiment, the insertion portion 4 is the part through which an insertion member IS such as a drive line is inserted, and is configured in a substantially cylindrical shape. As shown in Figures 14 to 16, the insertion portion 4 has a first opening 42 on the inside of the living body and a second opening 43 on the outside of the living body. The insertion passage 41 is formed between the first opening 42 and the second opening 43.

[0069] The shape and structure of the insertion portion 4 are not particularly limited, as long as the insertion portion 4 can support the insertion member IS in the state in which it is inserted into the insertion portion 4. In this embodiment, the insertion portion 4 is configured to protrude to the outside of the body. Specifically, as shown in Figure 14, the insertion portion 4 is configured such that the axis of the insertion passage 41 is inclined with respect to the surface of the sheet body 2, but the inclination angle of the axis of the insertion passage 41 is not particularly limited. The insertion passage 41 may also be provided perpendicular to the sheet body 2 (see schematic diagram in Figure 16, etc.).

[0070] Although not shown in the illustration, the insertion portion 4 may be positioned between the inner wall of the insertion passage 41 and the outer surface of the insertion member IS, and may include a chuck member that tightens and grips the outer circumferential surface of the insertion member IS, or a sealing member that holds the insertion member IS liquid-tight within the insertion passage 41. Since the chuck member, sealing member, etc., provided between the inner wall of the insertion passage 41 and the outer surface of the insertion member IS can be of known configuration, a detailed explanation is omitted. The material constituting the insertion portion 4 is made of a material that is biocompatible and has a predetermined rigidity. For example, as the material constituting the insertion portion 4, a metal material that is biocompatible and has high corrosion resistance, such as titanium or a titanium alloy, may be used.

[0071] In this embodiment, the insertion portion 4 has a mounting portion 44 to which the opening peripheral portion of the sheet body 2 and the inner peripheral portion of the first clamping member 51, which will be described later, are attached, as shown in Figures 15 to 17. The mounting portion 44 has an engaging step portion 44a configured to engage with the surface of the first clamping member 51 opposite to the surface that contacts the sheet body 2 in the thickness direction of the sheet body 2.

[0072] The mounting portion 44 is the portion where a part of the opening periphery of the sheet body 2 and the inner circumference of the first clamping member 51 are positioned when the sheet body 2 and the first clamping member 51 are attached to the insertion portion 4. The mounting portion 44 is configured so that the sheet body 2 and the first clamping member 51 can be fitted onto the end of the insertion portion 4 where the first opening 42 is provided. In this embodiment, as shown in Figures 14 to 17, the cylindrical portion on which the mounting portion 44 is provided is configured to be radially smaller than the cylindrical portion (second cylindrical portion) adjacent to the cylindrical portion (first cylindrical portion) on which the mounting portion 44 is provided in the axial direction (thickness direction of the sheet body 2). Due to the difference in radial size between the first cylindrical portion on which the mounting portion 44 is provided and the second cylindrical portion adjacent to the first cylindrical portion, the mounting portion 44 is provided with an engagement step portion 44a that acts as a step.

[0073] As shown in Figure 17, the engaging step portion 44a engages with the surface of the first clamping member 51 opposite to the surface that contacts the sheet body 2 (the outer surface) in the thickness direction of the sheet body 2 when the sheet body 2 and the first clamping member 51 are attached to the insertion portion 4. The engaging step portion 44a engages with the first clamping member 51 when force is applied to the sheet body 2 from the second clamping member 52 side toward the first clamping member 51 side, as will be described later, and the sheet body 2 is clamped. As a result, the sheet body 2 is clamped under pressure and stably held against the insertion portion 4. The shape and structure of the engaging step portion 44a are not particularly limited as long as the first clamping member 51 and the engaging step portion 44a can engage with each other. In this embodiment, the engaging step portion 44a is composed of an annular planar portion that partially faces the surface of the first clamping member 51 at the end side where the first opening 42 is provided.

[0074] In this embodiment, the length of the mounting portion 44 in the thickness direction of the sheet body 2, from the engaging step portion 44a to the end face 4a of the insertion portion 4 having the first opening 42, is configured to be smaller than the sum of the thickness of the first clamping member 51 and the thickness of the sheet body 2 (the thickness of the sheet body 2 in the arrangement portion 25 described later). In this case, the sheet body 2 is compressed by the first clamping member 51 and the second clamping member 52, preventing gaps from forming between the sheet body 2 and the first clamping member 51, and between the sheet body 2 and the second clamping member 52, thereby enabling a liquid-tight connection of the sheet body 2 to the insertion portion 4.

[0075] As shown in Figure 15, the insertion portion 4 has a fixing portion 45 to which the clamping portion 5 is fixed. In this embodiment, the fixing portion 45 is provided at the end (end face 4a in this embodiment) where the first opening 42 of the insertion portion 4 is provided. The fixing means between the insertion portion 4 and the clamping portion 5 is not particularly limited as long as it can fix the clamping portion 5 to the insertion portion 4 while the sheet body 2 is clamped by the clamping portion 5. In this embodiment, the fixing means between the insertion portion 4 and the clamping portion 5 is a fastening member SC such as a screw or bolt, and the fixing portion 45 is configured to fasten the fastening member SC. In this embodiment, the fixing portion 45 is a screw hole provided on the end face 4a where the first opening 42 of the insertion portion 4 is provided. When the fastening member SC is fastened through the second clamping member 52, the second clamping member 52 moves in a direction toward the first clamping member 51, and the clamping portion 5 is fixed to the insertion portion 4 while the sheet body 2 is compressed and clamped. By fixing the sheet body 2 to the insertion portion 4 while being held in the clamping portion 5, the sheet body 2 can be compressed uniformly, preventing gaps from forming between the insertion portion 4 and the sheet body 2, increasing the rigidity of the area on the opening edge 21a side of the sheet body 2 (placement portion 25), and preventing the sheet body 2 from coming out of the insertion portion 4.

[0076] As shown in Figures 14, 16, and 17, the clamping portion 5 clamps the portion of the sheet body 2 around the opening in the thickness direction. Also, as shown in Figure 16, the clamping portion 5 is fixed to the insertion portion 4, indirectly fixing the clamped sheet body 2 to the insertion portion 4. In this embodiment, as shown in Figures 14 to 17, the clamping portion 5 comprises an annular first clamping member 51 that contacts one surface 2a of the sheet body 2 around the opening, and an annular second clamping member 52 that contacts the other surface 2b of the sheet body 2 around the opening.

[0077] The first clamping member 51, together with the second clamping member 52, clamps the sheet body 2. One side of the first clamping member 51 contacts and engages with the engaging step portion 44a of the insertion portion 4, and the other side of the first clamping member 51 contacts one side 2a of the sheet body 2. The first clamping member 51 is made of a rigid, biocompatible material having a predetermined rigidity higher than that of the sheet body 2, and is arranged to surround the insertion portion 4 (mounting portion 44) as shown in Figures 14, 16, and 17.

[0078] The material constituting the first clamping member 51 is not particularly limited as long as it is biocompatible and has a predetermined rigidity higher than that of the sheet body 2. For example, a biocompatible and corrosion-resistant metal material such as titanium or a titanium alloy can be used as the material for the first clamping member 51. When titanium or a titanium alloy is used as the material for the first clamping member 51, bacteria are less likely to proliferate than on the sheet body 2, and the invasion of bacteria toward the living body along the first clamping member 51 can be suppressed. More specifically, bacteria that reach the surface of the first clamping member 51 from the outer surface of the insertion portion 4 are less likely to proliferate by traveling along the titanium or titanium alloy surface. Furthermore, even if bacteria proliferate toward the sheet body 2 (to the right in Figure 17) by traveling along the surface of the first clamping member 51, cell growth is promoted on the surface of the sheet body 2, so further bacterial proliferation is suppressed by cell growth. Furthermore, the path toward the other surface 2b of the sheet body 2 (the path through the gap between opposing members) is detoured by the fact that the mounting portion 44 and the arrangement portion 25 are arranged in a stepped, intricate manner, except for the through holes 23, 51a, etc. through which the filamentous body 3 passes. Therefore, bacteria are less likely to multiply, and it is difficult for bacteria to reach the other surface 2b of the sheet body 2. Consequently, healing of the incision site (target area) is promoted.

[0079] The shape of the first clamping member 51 is not particularly limited, as long as it can be attached to the insertion portion 4 and can clamp the sheet body 2 together with the second clamping member 52. In this embodiment, the first clamping member 51 is formed in a substantially elliptical (or substantially oblong) shape with an inner space, as shown in Figures 13, 18, and 19. The first clamping member 51 is also formed in a thin plate shape with one surface and the other surface. As shown in Figures 18 and 19, the first clamping member 51 has a plurality of through holes 51a formed in advance along the circumferential direction of the first clamping member 51 for sewing the fixing thread-like body 33.

[0080] As shown in Figures 17 and 18, the first clamping member 51 is positioned in an arrangement portion 25 provided around the opening of the sheet body 2. The arrangement portion 25 of the sheet body 2 is provided with a width corresponding to the width of the first clamping member 51 in the direction connecting the opening edge 21a of the opening 21 and the outer peripheral edge 22 of the sheet body 2. As a result, as shown in Figures 17 and 18, the first clamping member 51 and the opening edge 21a of the sheet body 2 coincide, allowing it to be attached to the mounting portion 44 of the insertion portion 4 without any gaps. Furthermore, the thickness of the sheet body 2 in the arrangement portion 25 is configured to be thinner than the thickness of the sheet body 2 on the outside of the arrangement portion 25 (on the outer peripheral edge 22 side of the sheet body 2). In this embodiment, the difference between the thickness of the sheet body 2 in the parts of the sheet body 2 other than the arrangement portion 25 and the thickness of the sheet body 2 in the arrangement portion 25 corresponds to the thickness of the first clamping member 51.

[0081] The second clamping member 52, together with the first clamping member 51, clamps the sheet body 2. The second clamping member 52 is fixed to the insertion portion 4, as shown in Figure 16. This indirectly fixes the sheet body 2, which is clamped between the first clamping member 51 and the second clamping member 52, to the insertion portion 4. In this embodiment, the second clamping member 52 is fastened to the insertion portion 4 so that it moves toward the first clamping member 51 in the thickness direction of the sheet body 2, thereby compressing and clamping the sheet body 2 and the first clamping member 51 between the engaging step portion 44a and the second clamping member 52. As a result, the sheet body 2 is stably fixed to the insertion portion 4 via the first clamping member 51 and the second clamping member 52. Therefore, when the sheet body 2 is fixed to a target area of ​​a living body, the insertion portion 4 is more easily maintained at a predetermined angle relative to the sheet body 2.

[0082] The material constituting the second clamping member 52 is not particularly limited as long as it is biocompatible and has a predetermined rigidity higher than that of the sheet body 2. For example, a biocompatible and corrosion-resistant metallic material such as titanium or a titanium alloy can be used as the material for the second clamping member 52.

[0083] The shape of the second clamping member 52 is not particularly limited, as long as it can be fixed to the insertion portion 4 and clamp the sheet body 2 together with the first clamping member 51. In this embodiment, the second clamping member 52 is formed in a substantially elliptical (or substantially oblong) shape with an inner space, as shown in Figures 18 and 22. The second clamping member 52 is also formed in a thin plate shape with one surface and the other surface. As shown in Figure 22, the second clamping member 52 has a plurality of pre-formed through holes 52a along the circumferential direction of the second clamping member 52 for sewing the fixing thread-like body 33. The through holes 52a of the second clamping member 52 are provided at positions corresponding to the positions of the through holes 51a of the first clamping member 51. The second clamping member 52 also has an insertion portion 52b for inserting fastening members SC such as screws and bolts, as shown in Figure 22. In this embodiment, the plurality of insertion portions 52b protrude inward from the annular portion of the second clamping member 52. As described later, with the sheet body 2 and the first clamping member 51 attached to the mounting portion 44 of the insertion portion 4, the second clamping member 52 is fixed to the insertion portion 4 by the fastening member SC inserted into the insertion portion 52b. As a result, the surface of the second clamping member 52 facing the other surface 2b of the sheet body 2 presses the sheet body 2 toward the first clamping member 51, compressing the sheet body 2 and holding it in the clamping portion 5.

[0084] As shown in Figures 16, 17, and 23, the fixing structure 1 has a fixing thread-like body 33 made up of thread-like bodies sewn to the sheet body 2 to fix the sheet body 2 and the clamping portion 5. The fixing thread-like body 33 is sewn to the surface of the sheet body 2 such that the sheet body 2 forms an uneven structure that resists relative movement of the sheet body 2 with respect to the target site of the living body through which the insertion member IS is inserted, in the direction in which the sheet body 2 extends. As described above, the fixing thread-like body 33 forms an uneven structure that resists relative movement with respect to the target site, so that when the fixing structure 1 is placed on the target site (wall-like tissue T), a part of the wall-like tissue T fits into the recesses of the uneven structure. Therefore, relative movement between the sheet body 2 and the wall-like tissue T in the direction in which the sheet body 2 extends parallel to the surface of the sheet body 2 is suppressed. Therefore, displacement of the sheet body 2 with respect to the target site can be suppressed without suturing the sheet body 2 to the target site such as skin. Thus, the fixing structure 1 can be quickly fixed to the target site with a simple procedure.

[0085] In this embodiment, the fixing structure 1 has a sheet-side filament 34 in addition to the fixing filament 33, but it may also have only the fixing filament 33 without the sheet-side filament 34. Alternatively, the fixing structure 1 may have only the sheet-side filament 34 without the fixing filament 33.

[0086] The thread-like material constituting the fixing thread-like material 33 can be the same as that of the first embodiment. The fixing thread-like material 33 is sewn to the sheet body 2 and the clamping part 5 in order to fix the sheet body 2 and the clamping part 5 together. In this embodiment, as shown in Figure 17, the outer end 33a of the fixing thread-like material 33 is inserted through a through hole 23 in the sheet body 2 that is located outside the arrangement part 25 of the sheet body 2, and the inner end 33b of the fixing thread-like material 33 is inserted through a through hole 23 provided in the sheet body 2 and through holes 51a and 52a provided in the clamping part 5, so that the fixing thread-like material 33 is sewn to the sheet body 2. The through hole 23 through which the fixing thread-like material 33 is inserted only needs to be able to accommodate the fixing thread-like material 33, and can be formed when sewing the fixing thread-like material 33 to the sheet body 2 with a sewing needle, or the through hole 23 can be formed in the sheet body 2 in advance. Furthermore, the through-hole 23 through which the fixing thread-like body 33 is inserted may be a common through-hole with the sheet-side thread-like body 34, or it may be a separate through-hole, depending on the size of the thread-like body and the size of the sheet body. Since the through-hole is formed when sewing the fixing thread-like body 33 to the sheet body 2 with a sewing needle, it is not necessary to form the through-hole in the sheet body 2 in advance, making it easy to form.

[0087] The fixing threads 33 are sewn radially, as shown in Figures 17 and 23. The length of the fixing threads 33 in the radial direction is not particularly limited. Preferably, the fixing threads 33 are sewn such that, for example, the outer end 33a of the fixing threads 33 is located in the area from the opening edge 21a of the sheet body 2 to 50% of the distance between the opening edge 21a and the outer peripheral edge 22 (for example, the area from 20% to 50%). Preferably, the fixing threads 33 are sewn so as to straddle (overlap with) the sheet body side threads 34 sewn to the sheet body 2. In this case, since the fixing threads 33 pass over the sheet body side threads 34, the height of the uneven structure formed by the fixing threads 33 and the sheet body side threads 34 from the surface of the sheet body 2 is increased. Therefore, the resistance when the fixing structure 1 moves against the wall-like tissue T is increased. Therefore, relative movement between the sheet body 2 and the wall-like tissue T in the direction of extension of the sheet body 2 parallel to the surface of the sheet body 2 is further suppressed. In addition to the minute space SP between the fixed filamentous body 33 and the surface of the sheet body 2 (see Figure 5), and the minute space SP between the sheet body-side filamentous body 34 and the surface of the sheet body 2 (see Figure 5), a minute space is also created between the fixed filamentous body 33 and the sheet body-side filamentous body 34. Consequently, cells of the wall-like tissue T enter these minute spaces, promoting healing of the wall-like tissue T at the incision site and enabling early fixation of the fixation structure 1 to the wall-like tissue T. Furthermore, as cells of the wall-like tissue T enter these minute spaces, the fixed filamentous body 33 and the sheet body-side filamentous body 34 are constrained by the entered cells. Therefore, even if the entire fixed structure 1 attempts to move relative to the wall-like tissue T, cells that have entered the minute spaces become entangled with the fixed filaments 33 and the sheet-side filaments 34, thereby suppressing the relative movement of the fixed structure 1 relative to the wall-like tissue T.

[0088] In this embodiment, as shown in Figures 16, 17, 21, and 23, the fixing structure 1 further includes a sheet-side thread-like body 34 sewn to the surface of the sheet body 2 so as to form an uneven structure on the outside of the clamping portion 5 that resists relative movement of the sheet body 2 with respect to the target site in the extending direction of the sheet body 2. The sheet-side thread-like body 34 forms an uneven structure that resists relative movement with respect to the target site, similar to the thread-like body 3 in the first to fifth embodiments. As a result, when the fixing structure 1 is placed on the target site (wall-like tissue T), a part of the wall-like tissue T fits into the recesses of the uneven structure. Therefore, relative movement between the sheet body 2 and the wall-like tissue T in the extending direction of the sheet body 2 parallel to the surface of the sheet body 2 is suppressed. Therefore, displacement of the sheet body 2 with respect to the target site can be suppressed without suturing the sheet body 2 to the target site such as skin. Thus, the fixing structure 1 can be quickly fixed to the target site with a simple procedure. The sheet-side filamentous body 34 can be the same filamentous body 3 or fixed filamentous body 33 described in the first to fifth embodiments above.

[0089] In this embodiment, the sheet-side thread-like material 34 is a thread-like material sewn only to the sheet body 2 and is not sewn to the clamping portion 5 (first clamping member 51 and second clamping member 52). The extension direction of the sheet-side thread-like material 34 is not particularly limited as long as the sheet-side thread-like material 34 can form the above-described uneven structure. For example, the sheet-side thread-like material 34 may extend radially, circumferentially, or inclined with respect to the radial or circumferential direction. In the sheet body 2, the region to which the sheet-side thread-like material 34 extends is not particularly limited as long as the sheet-side thread-like material 34 can form the above-described uneven structure. For example, it is preferable that the sheet-side thread-like material 34 is sewn to the outside of the clamping portion 5 and extends from the opening edge 21a of the sheet body 2 to 50% of the distance between the opening edge 21a and the outer peripheral edge 22 (for example, a region of 20-50%). Furthermore, in this embodiment, the sheet-side thread-like material 34 is shown as a cross-stitch portion 341 (see Figure 23), which will be described later. However, the sheet-side thread-like material 34 is not limited to the sewing pattern shown in Figure 23, and may be the thread-like material 3 described in the first to fifth embodiments, or it may be any other sewing pattern.

[0090] In this embodiment, as shown in Figure 23, the sheet-side filamentous bodies 34 have a cross-suture portion 341 where they intersect in the thickness direction of the sheet body 2. The cross-suture portion 341 is a suture portion having a structure in which at least two filamentous bodies extending in different directions intersect each other. When the sheet-side filamentous bodies 34 have a cross-suture portion 341, one of the intersecting filamentous bodies overlaps and rides on top of the other filamentous body. Therefore, at the intersection of the cross-suture portion 341, the height of the uneven structure formed by the cross-suture portion 341 increases in the direction perpendicular to the surface of the sheet body 2 (the thickness direction of the sheet body 2). Therefore, when the fixation structure 1 is placed on a target site in a living body, the frictional force between the fixation structure 1 and the target site in the living body can be increased, and the slippage of the fixation structure 1 with respect to the target site such as skin can be further suppressed. In addition, minute spaces are created between the intersecting filamentous bodies in the cross-suture portion 341. Therefore, the fixation structure 1 forms a more complex three-dimensional structure, making it easier for cells to enter and fixate.

[0091] In this embodiment, the cross-suture portion 341 is formed by two filamentous portions that extend from the inside to the outside of the sheet body 2 at a slight inclination with respect to the radial direction, intersecting each other, as shown in Figure 23. However, the direction in which the filamentous portions of the cross-suture portion 341 extend is not particularly limited, as long as they intersect in an overlapping manner in the thickness direction of the sheet body 2. For example, the cross-suture portion may be configured such that filamentous portions extending in the radial direction and filamentous portions extending in the circumferential direction intersect each other in a cross shape. Alternatively, the cross-suture portion may consist of three or more filamentous portions that intersect each other.

[0092] In Figure 23 and Figures 24 to 28 relating to embodiments described later, the filamentous bodies (fixed filamentous body 33, sheet-side filamentous body 34) are simplified and shown as lines. However, in reality, the filamentous bodies have a predetermined thickness, and as explained in the first embodiment, only a small clearance is formed between the through holes 23, 51a, 52a and the filamentous bodies (see the explanation of clearance CL in Figure 6).

[0093] In this embodiment, the method for manufacturing the fixed structure 1 is not particularly limited, but as an example, it can be manufactured as follows. However, the following manufacturing method is merely an example, and the method for manufacturing the fixed structure 1 is not limited, and the present invention is not limited by the following description.

[0094] First, the sheet body side thread-like material 34 is sewn to the sheet body 2 to form a sewing structure such as a cross-sewn portion 341, as shown in Figure 21. With the sheet body side thread-like material 34 sewn to it, the sheet body 2 and the first clamping member 51 are positioned on the placement portion 25 of the sheet body 2, and then positioned on the attachment portion 44 of the insertion portion 4 from one end of the insertion portion 4. Next, the second clamping member 52 is positioned on the other side 2b of the sheet body 2 so as to follow the opening edge 21a of the sheet body 2. In this state, the second clamping member 52 is fastened to the fixing portion 45 of the insertion portion 4 by the fastening member SC. Next, the fixing thread-like material 33 is sewn to the sheet body 2, the first clamping member 51 and the second clamping member 52 along the entire circumference of the sheet body 2. This stably fixes the sheet body 2 and the clamping portion 5. Furthermore, since the second clamping member 52 is fixed to the insertion portion 4, the sheet body 2, the clamping portion 5, and the insertion portion 4 are fixed to each other, and the sheet body 2 is stably held in place by the insertion portion 4. The fixing thread-like body 33 may be sewn to the sheet body 2, the first clamping member 51, and the second clamping member 52 before the second clamping member 52 is fastened to the fixing portion 45 of the insertion portion 4.

[0095] <Seventh Embodiment> The seventh embodiment differs from the sixth embodiment in that an auxiliary suture portion 342 is provided, as shown in Figure 24. Aside from the provision of the auxiliary suture portion 342, the configuration is the same as that of the sixth embodiment. Note that the configuration described below can also be applied to other embodiments, and configurations from other embodiments can be applied to this embodiment.

[0096] In this embodiment, as shown in Figure 24, the sheet body side filamentous body 34 includes, in addition to the cross suture portion 341, an auxiliary suture portion 342 provided adjacent to the cross suture portion 341 in the circumferential direction of the sheet body 2, in the region between the central portion of the cross suture portion 341 (a predetermined radial region including the cross portion 341a) and the inner end 341b, in the direction connecting the opening edge 21a of the opening 21 and the outer peripheral edge 22 of the sheet body 2.

[0097] The auxiliary suture portion 342 is a suture portion provided auxiliaryly on the sheet body 2 to reinforce the uneven structure formed by the cross suture portion 341. The structure of the auxiliary suture portion 342 is not particularly limited as long as it can reinforce the uneven structure formed by the cross suture portion 341. In this embodiment, the auxiliary suture portion 342 is shown as a linear suture portion extending radially. However, the auxiliary suture portion may extend in the circumferential direction, or it may extend in a zigzag shape rather than a straight line. Also, as shown in Figure 25, the auxiliary suture portion 342 may intersect so as to overlap in the thickness direction of the sheet body 2.

[0098] In this embodiment, as described above, the auxiliary suture portion 342 is provided in the region between the central portion of the cross suture portion 341 and the inner end 341b. This allows the filamentous material to be densely packed in the region between the central portion of the cross suture portion 341 and the inner end 341b by the cross suture portion 341 and the auxiliary suture portion 342. Therefore, the rigidity of the sheet body 2 is increased in the region between the central portion of the cross suture portion 341 and the inner end 341b. As a result, the fixing structure 1 is less likely to deform on the inner end 341b side of the cross suture portion 341. Therefore, as described above, the insertion member IS inserted through the fixing structure 1 can be maintained at a predetermined angle with respect to the target site (wall-like tissue T). Therefore, deformation of the fixing structure 1 or tilting relative to the wall-like tissue T prevents cells that have grown between the fixing structure 1 and the wall-like tissue T from detaching. Therefore, cell growth is not inhibited, cell proliferation becomes active on the inner end 341b side of the cross suture portion 341, promoting healing of the incision site and suppressing downgrowth. The inner end 341b of the cross suture portion 341 is located at a position adjacent in the radial direction to the outer circumference of the clamping portion 5 (first clamping member 51) on the surface (one surface 2a) of the sheet body 2 (not limited to, for example, within 20% of the distance between the opening edge 21a and the outer edge 22 from the outer circumference of the first clamping member 51). The central portion (crossing portion 341a) of the cross suture portion 341 is located at a position adjacent in the radial direction to the outer circumference of the clamping portion 5 (first clamping member 51) (not limited to, but for example, within 30-50% of the distance between the opening edge 21a and the outer edge 22 from the outer circumference of the first clamping member 51).

[0099] Furthermore, the rigidity of the sheet body 2 is increased in the region between the central part of the cross suture portion 341 and the inner end 341b, making the sheet body 2 less prone to bending in the portion of the sheet body 2 that is radially adjacent to the outer circumference of the clamping portion 5 (first clamping member 51) where the inner end 341b of the cross suture portion 341 is provided. Therefore, even if a thin and flexible sheet body 2 is used for the fixing portion (flange-shaped portion) of the fixing structure 1 to the living body, it is possible to stably support the insertion portion 4 and insertion member IS having a predetermined size and weight at a predetermined angle. Note that the description "the region between the central part of the cross suture portion 341 and the inner end 341b" where the auxiliary suture portion 342 is provided refers to any region between the central part and the inner end 341b. Therefore, the auxiliary suture portion 342 may not be provided in the region corresponding to the inner end 341b of the cross suture portion 341, but only in the region corresponding to the central portion of the cross suture portion 341; or it may not be provided in the region corresponding to the central portion, but only in the region corresponding to the inner end 341b; or it may be provided over the entire region from the central portion to the inner end 341b.

[0100] Furthermore, in this embodiment, the outer end 342a of the auxiliary suture portion 342 is positioned inward relative to the outer end 341c of the cross suture portion 341, as shown in Figures 24 and 25. As a result, the sheet body side filaments 34 provided on the sheet body 2 become denser from the inside to the outside due to the cross suture portion 341 and the auxiliary suture portion 342. Therefore, as described above, the rapid change in the rigidity of the sheet body 2 and the application of localized stress are suppressed, and the bending of the sheet body 2 and the separation of the parts where the surface of the sheet body 2 and the cells of the wall-like tissue T were fixed are suppressed, which would delay the healing of the incision site.

[0101] <Eighth Embodiment> The eighth embodiment differs from the seventh embodiment in that the auxiliary suture portion 342 is provided in a position overlapping the cross suture portion 341, as shown in Figures 26 and 27, but the other configurations are the same as those of the seventh embodiment. The configurations described below can also be applied to other embodiments, and the configurations of other embodiments can also be applied to this embodiment.

[0102] As shown in Figures 26 and 27, in this embodiment, the auxiliary suture portion 342 is provided in a region between the central part of the cross suture portion 341 and the inner end 341b, overlapping the cross suture portion 341. When the cross suture portion 341 and the auxiliary suture portion 342 are provided overlapping, the height in the thickness direction of the sheet body 2 increases in the portion where the thread-like material of the cross suture portion 341 and the thread-like material of the auxiliary suture portion 342 overlap. Specifically, in addition to the intersection of the thread-like material of the cross suture portion 341, the thread-like material of the cross suture portion 341 and the thread-like material of the auxiliary suture portion 342 also intersect. Therefore, the frictional force between the fixing structure 1 and the target part of the living body can be increased at the intersection of the thread-like material of the cross suture portion 341, and at the intersection of the thread-like material of the cross suture portion 341 and the thread-like material of the auxiliary suture portion 342. Furthermore, minute spaces are created in the gaps between the filamentous bodies of the cross suture portion 341 and the filamentous bodies of the auxiliary suture portion 342, forming a more complex three-dimensional structure that allows cells to enter and settle more easily. Regarding the auxiliary suture portion 342, "located in a position overlapping the cross suture portion 341" means that a portion of the filamentous bodies constituting the cross suture portion 341 and a portion of the filamentous bodies constituting the auxiliary suture portion 342 are arranged to overlap and intersect at some point. Therefore, the intersection of the cross suture portion 341 and the intersection of the auxiliary suture portion 342 may be misaligned. In this embodiment, as shown in Figure 26, the intersection of the cross suture portion 341 and the intersection of the auxiliary suture portion 342 overlap in the thickness direction of the sheet body 2. In this case, the height of the uneven structure becomes higher, further increasing the frictional force between the fixing structure 1 and the target area of ​​the living body. Furthermore, the intersection of the cross suture portion 341 and the auxiliary suture portion 342 forms a more complex three-dimensional structure, which allows cells to enter and settle more easily.

[0103] <Ninth Embodiment> In the ninth embodiment, as shown in Figure 28, the region where the auxiliary suture portion 342 is provided is the region on the outer end 341c side of the cross suture portion 341, which is different from the eighth embodiment, but the other configurations are the same as in the eighth embodiment. The configurations described below can also be applied to other embodiments, and the configurations of other embodiments can also be applied to this embodiment.

[0104] In this embodiment, as shown in Figure 28, the auxiliary suture portion 342 is provided in the region on the outer end 341c side of the cross suture portion 341, at a position overlapping the cross suture portion 341. When the auxiliary suture portion 342 is provided on the outer end 341c side of the cross suture portion 341, the area having a cross structure increases, which has the effect of making it easier for cells to invade and suppressing displacement. Furthermore, if the first clamping member 51 has thickness, the difference in rigidity between the first clamping member 51 and the sheet body 2 can be further reduced.

[0105] In Figure 28, the auxiliary suture portion 342 is provided in a position overlapping the cross suture portion 341. However, as a modified example, the auxiliary suture portion may be provided adjacent to the cross suture portion 341 in the circumferential direction of the sheet body 2, in the region on the outer end 341c side of the cross suture portion 341.

[0106] It should be noted that the embodiments described above are merely examples, and the present invention is not limited to the embodiments described above. For example, the stitching pattern of the thread-like material may be uniform in the circumferential direction, or it may be switched to different stitching patterns in the circumferential direction. Also, the positions of the outer end and / or inner end of the thread-like material may vary in the circumferential direction.

[0107] Although embodiments of the present invention have been described above, the present invention is not limited to the embodiments described above. The embodiments described above mainly describe an invention having the following configuration.

[0108] (1) A porous sheet body having an opening through which an insertion member to be brought out from inside the body can be inserted, and composed of a biocompatible, non-absorbable material, A cylindrical insertion portion having an insertion passage for guiding the insertion member from inside the body to outside the body, The clamping portion is fixed to the insertion portion and clamps the portion of the sheet body around the opening in the thickness direction of the sheet body, A fixing thread-like body, which is made up of a thread-like body sewn onto the sheet body, is used to fix the sheet body and the clamping portion. It has, The fixing structure is sewn onto the surface of the sheet body such that the fixing thread-like material forms an uneven structure that resists relative movement of the insertion member with respect to the target part of the living body through which it is inserted, in the direction of extension of the sheet body.

[0109] (2) The fixing structure further The fixing structure according to (1), further comprising a sheet-side thread-like body sewn onto the surface of the sheet body so as to form an uneven structure on the outside of the clamping portion that resists relative movement of the sheet body with respect to the target portion in the extending direction of the sheet body.

[0110] (3) The fixing structure according to (1) or (2), wherein the sheet-side filamentous material has a cross-suturing portion in which it intersects so as to overlap in the thickness direction of the sheet.

[0111] (4) The fixing structure according to any one of (1) to (3), wherein the sheet body side filamentous body is provided with an auxiliary suture portion located adjacent to or overlapping with the cross suture portion in the circumferential direction of the sheet body, in a region between the central portion and the inner end of the cross suture portion in the direction connecting the opening edge of the opening and the outer peripheral edge of the sheet body.

[0112] (5) The fixing structure according to any one of (1) to (4), wherein the outer end of the auxiliary suture portion is provided so as to be located inward relative to the outer end of the cross suture portion.

[0113] (6) The fixing structure according to any one of (1) to (5), wherein the auxiliary sutures intersect so as to overlap in the thickness direction of the sheet body.

[0114] (7) The fixing structure according to any one of (1) to (6), wherein the intersection portion of the cross suture and the intersection portion of the auxiliary suture overlap in the thickness direction of the sheet body.

[0115] (8) The fixing structure according to any one of (1) to (7), wherein the sheet-side thread-like material is provided with an auxiliary suture portion located adjacent to or overlapping with the cross suture portion in the circumferential direction of the sheet, in the region on the outer end side of the cross suture portion in the direction connecting the opening edge of the opening and the outer peripheral edge of the sheet.

[0116] (9) The fixing structure according to any one of (1) to (8), wherein the auxiliary sutures intersect so as to overlap in the thickness direction of the sheet body.

[0117] (10) The clamping portion comprises an annular first clamping member that contacts one surface of the sheet body in the periphery of the opening of the sheet body, and an annular second clamping member that contacts the other surface of the sheet body in the periphery of the opening of the sheet body, The first clamping member is made of a rigid, biocompatible material having a predetermined rigidity higher than that of the sheet body, and is arranged to surround the insertion portion. The second clamping member is fixed to the insertion portion, according to any one of (1) to (9) of the fixing structure.

[0118] (11) The insertion portion has an attachment portion to which the opening peripheral portion of the sheet body and the inner peripheral portion of the first clamping member are attached, The mounting portion has an engagement step configured to engage with the sheet body in the thickness direction on the surface of the first clamping member opposite to the surface that contacts the sheet body, The fixing structure according to any one of (1) to (10), wherein the second clamping member is fastened to the insertion portion such that it moves toward the first clamping member in the thickness direction of the sheet body, so that the sheet body and the first clamping member are compressed and sandwiched between the engaging step and the second clamping member.

[0119] (12) The fixing structure according to any one of (1) to (11), wherein the sheet body has an arrangement portion for arranging the first clamping member around the opening, the arrangement portion is provided with a width corresponding to the width of the first clamping member in the direction connecting the opening edge of the opening and the outer peripheral edge of the sheet body, and the thickness of the sheet body in the arrangement portion is configured to be thinner than the thickness of the sheet body outside the arrangement portion.

[0120] (13) The fixing structure according to any one of (1) to (12), wherein the sheet-side filamentous material is sewn to the sheet body so that it becomes denser towards the outer edge of the sheet body from the central region around the opening of the sheet body.

[0121] (14) The fixing structure according to any one of (1) to (13), wherein the thread-like body has a plurality of radial sutures extending in a radial direction that connects the opening and the outer edge of the sheet body.

[0122] (15) The fixing structure according to any one of (1) to (14), wherein the radial suture portion extends radially with a length that does not reach the outer edge from the opening.

[0123] (16) The fixing structure according to any one of (1) to (15), wherein the radial suture portion comprises a plurality of first radial suture portions extending radially from the opening for a predetermined length, and a plurality of second radial suture portions extending radially from the opening for a length shorter than the length of the first radial suture portions. [Explanation of Symbols]

[0124] 1 Fixed structure 2 sheets 2a One side of the sheet 2b The other side of the sheet 21. Opening of the sheet body 21a Opening edge 22 Peripheral edge of the sheet body 23 Through hole 24 Non-sutured area 25 Placement section 3. Filamentous bodies 31 Radial suture 311 First radial suture 311a Outer end of the first radial suture 311b Inner end of the first radial suture 312 Second radial suture 312a Outer end of the second radial suture 312b Inner end of the second radial suture 313 Third radial suture 313a Outer end of the third radial suture 313b Inner end of the third radial suture 32 Circumferential suture 33. Fixed filamentous body 33a Outer end of the fixed filamentous body 33b Inner end of the fixed filament 34 Sheet-side filamentous bodies 341 Cross suture 341a Crossing portion of the cross suture 341b Inner end of cross suture 341c Outer end of cross suture 342 Auxiliary suture site 342a Outer end of auxiliary suture 4 Insertion part 4a End face of the insertion portion 41 Insertion passage 42 First opening 43. Second opening 44 Mounting part 44a Engagement stepped portion 45 Fixed part 5 Clamping part 51 First clamping member 51a Through hole 52 Second clamping member 52a through hole 52b Insertion section C connecting member C1 First connecting member C2 Second connecting member CL Clearance between the inner circumference of the sheet body and the filamentous body D Fixation device IS insertion member Ra central area (1st area) Rb Peripheral region (4th region) Rc intermediate area Rc1 1st intermediate area (2nd area) Rc2 2nd intermediate area (3rd area) SC fastening member SP (Small Space) T Wall-like tissue

Claims

1. A porous sheet body having an opening through which an insertion member can be inserted from inside to outside the body, and composed of a biocompatible, non-absorbable material, A cylindrical insertion portion having an insertion passage for guiding the insertion member from inside the body to outside the body, The clamping portion is fixed to the insertion portion and clamps the portion of the sheet body around the opening in the thickness direction of the sheet body, A fixing thread-like body, which is made up of a thread-like body sewn onto the sheet body, is used to fix the sheet body and the clamping portion. It has, The fixing structure is sewn onto the surface of the sheet body such that the fixing thread-like material forms an uneven structure that resists relative movement of the insertion member with respect to the target part of the living body through which it is inserted, in the direction of extension of the sheet body.

2. The aforementioned fixing structure further, The fixing structure according to claim 1, further comprising a sheet-side thread-like body sewn to the surface of the sheet body so as to form an uneven structure on the outside of the clamping portion that resists relative movement of the sheet body with respect to the target portion in the extending direction of the sheet body.

3. The fixing structure according to claim 2, wherein the sheet-side filamentous bodies intersect in a cross-suturing portion so as to overlap in the thickness direction of the sheet-body.

4. The fixing structure according to claim 3, wherein the sheet body side filamentous body includes an auxiliary suture portion provided in the region between the central portion and the inner end of the cross suture portion in the direction connecting the opening edge of the opening and the outer peripheral edge of the sheet body, adjacent to or overlapping the cross suture portion in the circumferential direction of the sheet body.

5. The fixing structure according to claim 4, wherein the outer end of the auxiliary suture portion is provided to be located inward relative to the outer end of the cross suture portion.

6. The fixing structure according to claim 5, wherein the auxiliary suture portions intersect in the thickness direction of the sheet body so as to overlap.

7. The fixing structure according to claim 6, wherein the intersection portion of the cross suture and the intersection portion of the auxiliary suture overlap in the thickness direction of the sheet body.

8. The fixing structure according to claim 3, wherein the sheet body side filamentous body includes an auxiliary suture portion provided in the region on the outer end side of the cross suture portion in the direction connecting the opening edge of the opening and the outer peripheral edge of the sheet body, adjacent to or overlapping the cross suture portion in the circumferential direction of the sheet body.

9. The fixing structure according to claim 8, wherein the auxiliary suture portions intersect in the thickness direction of the sheet body so as to overlap.

10. The clamping portion comprises an annular first clamping member that contacts one surface of the sheet body in the area surrounding the opening of the sheet body, and an annular second clamping member that contacts the other surface of the sheet body in the area surrounding the opening of the sheet body. The first clamping member is made of a rigid, biocompatible material having a predetermined rigidity higher than that of the sheet body, and is arranged to surround the insertion portion. The fixing structure according to claim 1, wherein the second clamping member is fixed to the insertion portion.

11. The insertion portion has a mounting portion to which the portion around the opening of the sheet body and the portion on the inner circumference of the first clamping member are attached. The mounting portion has an engagement step configured to engage with the surface of the first clamping member opposite to the surface that contacts the sheet body in the thickness direction of the sheet body, The fixing structure according to claim 10, wherein the second clamping member is fastened to the insertion portion such that it moves toward the first clamping member in the thickness direction of the sheet body, so that the sheet body and the first clamping member are compressed and sandwiched between the engaging step and the second clamping member.

12. The fixing structure according to claim 10, wherein the sheet body has an arrangement portion for arranging the first clamping member in the area surrounding the opening, the arrangement portion is provided with a width corresponding to the width of the first clamping member in the direction connecting the opening edge of the opening and the outer peripheral edge of the sheet body, and the thickness of the sheet body in the arrangement portion is configured to be thinner than the thickness of the sheet body outside the arrangement portion.

Images