Fixing device

Abstract

This fixing device is provided with a porous sheet body (2), a device main body (3) provided with a through-hole (31), the device main body (3) having a flange section (32) extending outward at a predetermined width along the outer periphery of a first end section (31a), and an annular clamping member (4) that can be attached to the outside of the first end section (31a) of the through-hole (31) and that can be inserted into the through-hole (31), the device main body (3) having a flange section (32) extending outward at a predetermined width along the outer periphery of the first end section (31a) of the through-hole (31). The flange section (32) has a first surface (32a) that serves as the outside of the body in a state where the fixing device (1) is attached to the living body, and the sheet body (2) is inserted through a first end section (31a) of the insertion section (31) and is sandwiched between the first surface (32a) of the flange section (32) and the sandwiching member (4). With such a structure, it is possible to provide a fixing device capable of suppressing the generation of steps between a biocompatible sheet embedded in a living body and the living body.

Description

Technical Field

[0001] This invention relates to a fixing device. Background Technology

[0002] When inserting a medical tube from outside the body into the body, as shown in Patent Document 1, a skin fixation component is disclosed, which is configured to clamp a biocompatible nonwoven fabric such as PTFE felt using an internal protrusion protruding inward and a fixing nut.

[0003] Existing technical documents Patent documents Patent Document 1: Japanese Patent Application Publication No. 2019-166310 Summary of the Invention The problem that the invention aims to solve In the skin fixation component of Patent Document 1, the nonwoven fabric is fixed using an external threaded portion provided in the inner side protrusion and a fixing nut. Therefore, a step is created between the inner side surface of the nonwoven fabric and the inner side surface of the skin fixation component (the inner side portion of the inner side protrusion and the inner side portion of the fixing nut). If such a step is created, a portion where cells cannot adhere is formed at the step portion, hindering cell invasion into the nonwoven fabric.

[0004] Therefore, the object of the present invention is to provide a fixation device that can suppress the formation of steps between a biocompatible sheet embedded in an organism and the organism.

[0005] Methods for solving problems The fixation device of the present invention comprises: a porous sheet made of a non-absorbent material with biocompatibility; a device body having a through portion through which a through member extending from inside the organism to outside the organism passes; and an annular clamping member, wherein the device body has a flange portion extending outwardly with a predetermined width along the outer periphery of a first end portion of the through portion that is inside the organism when the fixation device is installed in the organism, the clamping member being able to be installed on the outer side of the first end portion of the through portion, the flange portion having a first surface that is outside the organism when the fixation device is installed in the organism, the sheet portion passing through the first end portion of the through portion and being clamped by the first surface of the flange portion and the clamping member.

[0006] The effects of the invention The fixing device according to the present invention can suppress the formation of steps between the biocompatible sheet embedded in the organism and the organism. Attached Figure Description

[0007] Figure 1This is a schematic diagram showing the state in which the fixing device of one embodiment of the present invention is installed on a wall-like tissue.

[0008] Figure 2 This is an exploded perspective view of a fixing device according to an embodiment of the present invention.

[0009] Figure 3 yes Figure 2 The side view of the main body of the device shown.

[0010] Figure 4 yes Figure 2 The top view of the main body of the device shown.

[0011] Figure 5 yes Figure 2 The top view of the clamping component shown.

[0012] Figure 6 This is a diagram showing a modified example of the clamping component.

[0013] Figure 7 This diagram shows the state in which the sheet is mounted on the main body of the device.

[0014] Figure 8 It means from Figure 7 The diagram shows the state from the state of the clamping member during installation, to the state of the clamping member passing through the through part, and before the clamping member crosses the engaging step.

[0015] Figure 9 It is a cross-sectional view of the fixing device in which the sheet is clamped by the clamping member and the flange.

[0016] Figure 10 It is an enlarged view of the part of the sheet body that is held by the clamping components and the flange.

[0017] Figure 11 This diagram shows the state in which the sheet is sewn onto the linear body while being held by the clamping member and the flange. Detailed Implementation

[0018] Hereinafter, with reference to the accompanying drawings, a fixing device according to one embodiment of the present invention will be described. It should be noted that the embodiment shown below is merely an example, and the fixing device of the present invention is not limited to the following embodiment.

[0019] It should be noted that, in this specification, "perpendicular to A" and similar expressions do not only refer to a direction that is completely perpendicular to A, but also include cases where it is approximately perpendicular to A. Similarly, in this specification, "parallel to B" and similar expressions do not only refer to a direction that is completely parallel to B, but also include cases where it is approximately parallel to B. Furthermore, in this specification, "C-shape" and similar expressions do not only refer to a perfect C-shape, but also include shapes that are visually reminiscent of a C-shape (approximately C-shaped).

[0020] like Figure 1 As shown, the fixation device 1 of this embodiment is used when a penetrating member IS, which is extended from inside the organism to outside the organism, is fixed to the wall-like tissue T of the organism. Figure 1 As shown, the fixation device 1, with the penetrating member IS passing through it, is embedded at a predetermined position and depth in the wall-like tissue T, thereby fixing it to the wall-like tissue T of the organism. The purpose of the fixation device 1 is simply to fix the penetrating member IS, which extends from inside the organism to outside the organism, to the wall-like tissue T of the organism; there is no particular limitation. For example, the fixation device 1 can be used for skin buttons (flanged members) penetrated by the penetrating member IS, etc.

[0021] In this specification, "organism" refers to the body of animals other than humans. "Wall-like tissue" refers to any wall, membrane, or other tissue of an organism having a predetermined thickness that is penetrated by the penetrating member IS. Specifically, wall-like tissue refers to various tissues within an organism, such as skin (epidermis, dermis, subcutaneous tissue), muscle layer, and tissues constituting various organs, as well as layers composed of these tissues. In this embodiment, the wall-like tissue T penetrated by the penetrating member IS is tissue that includes skin (epidermis, dermis, subcutaneous tissue) and muscle layer. The fixation position (embedding position) of the wall-like tissue T fixed by the fixation device 1 can be appropriately changed according to the body shape of the patient (organism) fixed by the fixation device 1.

[0022] The purpose of the fixation device 1 is simply to fix the penetrating member IS, which is led from inside the body to outside the body, to the wall-like tissue T of the body; there is no particular limitation. In this embodiment, the fixation device 1 is used when the drive tube (penetrating member IS) used by a medical device (e.g., a VAD, artificial lung, or other artificial organ) implanted in the human body is inserted through the wall-like tissue T of the abdomen, and the drive tube is led from inside the body to outside the body. Figure 1 As shown, the drive tube leading out of the body is fixed at a predetermined position on the abdomen via a fixation device 1.

[0023] The penetrating member IS is a linear member of a predetermined length that penetrates the wall-like tissue T of a living organism. It should be noted that "linear" in the penetrating member IS refers to the fact that the penetrating member IS extends to a predetermined length, regardless of whether the penetrating member IS is hollow or solid. In this embodiment, the penetrating member IS is a medical strip member configured to penetrate the wall-like tissue T of a living organism. More specifically, the penetrating member IS is a drive conduit for an artificial organ (artificial assistive heart). One end of the penetrating member IS is connected to an artificial organ (not shown) disposed at a predetermined location within the body, and the other end is connected to a device (power supply, etc.) disposed externally.

[0024] The internal structure of the penetrating component IS is not particularly limited. For example, the penetrating component IS has a cooling water circulation path that circulates cooling water between the artificial organ inside the body and the external pressure pump, as well as a power cable connecting the artificial organ inside the body and the power source outside the body. It should be noted that the penetrating component IS can be a structure with only a power cable or a structure with only a cooling water circulation path. In addition, the penetrating component IS can be configured to have components with other functions besides those mentioned above, or it can be configured to be a hollow component (tube) without internal components. When used as a hollow component connecting the inside and outside of the body, the penetrating component IS can also be used to deliver therapeutic drugs from outside the body to the treatment site inside the body.

[0025] When a penetrating member IS penetrates a wall-like tissue T, for example, as... Figure 1 As shown, with the through member IS penetrating through the fixing device 1, the fixing device 1 is fixed to the wall-shaped tissue T. (As indicated...) Figure 1 and Figure 2 As shown, the fixing device 1 of this embodiment includes: a porous sheet 2 made of a non-absorbent material with biocompatibility; a device body 3 having a through portion 31 through which a through member IS, which can be directed from inside the organism to outside the organism, passes; and an annular clamping member 4. In this embodiment, as Figure 1 As shown, the sheet 2 is fixed to the wall-shaped tissue T while being held by the flange 32 (described later) and the clamping member 4 provided on the main body 3 of the device, as will be described in detail later. Thus, the penetrating member IS is fixed at a predetermined position via the fixing device 1 in a state of penetrating the wall-shaped tissue T.

[0026] The sheet 2 is embedded in the wall-shaped tissue T at the location where the fixing device 1 is fixed (attached) to the wall-shaped tissue T while the penetrating member IS is penetrating through the wall-shaped tissue T (see reference). Figure 1 ).like Figure 1As shown, the sheet 2 penetrates the first end 31a of the through portion 31 and is held by the first surface 32a of the flange portion 32 and the clamping member 4, as will be described in detail later. For example, while held by the first surface 32a of the flange portion 32 and the clamping member 4, the sheet 2 is embedded in the wall-like tissue T such that it is inserted beneath a portion (e.g., skin) of the wall-like tissue T that has been cut to penetrate the through portion 32. Thus, as... Figure 1 As shown, the sheet 2 is fixed to a predetermined location on the wall-like tissue T.

[0027] The sheet 2 is made of a biocompatible, non-absorbent material. The biocompatible, non-absorbent material constituting the sheet 2 can be the same material used in the body or at wound sites as a medical sheet. The sheet 2 is preferably made of a soft material. The material constituting the sheet 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, fluoropolymer resin, urea resin, phenolic resin, epoxy resin, polyimide resin, acrylic resin, and methacrylic resin, and their derivatives, and is preferably extended polytetrafluoroethylene (ePTFE).

[0028] Furthermore, to promote the growth and attachment of cell wall-like tissue T to sheet 2, sheet 2 is preferably composed of a porous sheet. The pore size (average pore size) of the porous sheet 2 is not particularly limited, as long as it facilitates cell growth and attachment when sheet 2 is embedded in the cell wall-like tissue T. For example, the average pore size of sheet 2 can be set to 10 μm to 100 μm.

[0029] The shape of the sheet 2 is not particularly limited as long as it can pass through the through-hole 31 and the through-hole member IS, and is suitable for embedding in the wall-like tissue T. In this embodiment, the sheet 2 has an opening 21 in the central part. In this embodiment, the sheet 2 is formed into a generally elliptical shape (generally oblong), but it can also be formed into a circular, polygonal, or other shapes other than those shown in the figure. The size of the sheet 2 is not particularly limited and can be appropriately changed according to the size of the through-hole 31 of the device body 3 through which the sheet 2 passes, the purpose of the fixing device 1, and the fixing position. In this embodiment, the sheet 2 is set to a size that extends outward relative to the flange 32 of the device body 3. The sheet 2 can be set to the same size as the flange portion of a known skin button (flanged member) embedded in the wall-like tissue T. When the sheet 2 has the shape shown in the figure, the length of the sheet 2 can be set to, for example, 10 mm to 80 mm, and the length of the short side can be set to, for example, 5 mm to 60 mm (for example, about 30% to 50% of the length of the long side). Furthermore, the thickness of the sheet 2 is not particularly limited, and can be set to, for example, 0.5mm to 5mm. Additionally, when the sheet is circular, its diameter can be set to, for example, 5mm to 80mm.

[0030] An opening 21 is provided in the sheet body 2 and extends through the central portion of the sheet body 2 along the thickness direction of the sheet body 2. The size of the opening 21 is appropriately set to allow the sheet body 2 to pass through the first end 31a of the through portion 31 of the fixing device 1.

[0031] The main body 3 of the device is a base portion of a fixing device 1, in which a through member IS penetrates the inner side and a plate 2 and a clamping member 4 are mounted on the outer side. In this embodiment, as... Figure 3 and Figure 4 As shown, the main body 3 of the device has: a through portion 31 through which the through member IS can pass; and a flange portion 32 that extends outward in the through portion 31 along the outer periphery of the first end 31a, which is the inner side of the body when the fixing device 1 is installed in the organism, with a predetermined width.

[0032] The through-hole 31 is a portion in the main body 3 through which the through-hole member IS passes. The through-hole 31 connects the inside of the organism to the outside. In this embodiment, the through-hole 31, which is the portion through which through-hole members IS such as drive pipes pass, is configured to be approximately cylindrical. Figures 1-3 As shown, the through portion 31 has a first end portion 31a that becomes the inner side of the organism and a second end portion 31b that becomes the outer side of the organism. Figure 9As shown, the through portion 31 has a first opening 311a located on the side of the first end 31a (inside the organism) and a second opening 311b located on the side of the second end 31b (outside the organism). A through path 311 is provided between the first opening 311a and the second opening 311b, penetrating the through portion 31. It should be noted that the first end 31a is a predetermined region in the through portion 31 extending from the first opening 311a toward the second opening 311b, and the second end 31b is a predetermined region in the through portion 31 extending from the second opening 311b toward the first opening 311a. In this embodiment, as... Figure 3 As shown, the outer portion of the first end portion 31a (the mounting portion 312 described later) is configured as a body extending in a separation direction D that separates from the flange portion 32 (an imaginary surface S formed such that the outer periphery of the flange portion 32 is contained within a surface (hereinafter simply referred to as the imaginary surface S of the flange portion 32)). It should be noted that the separation direction D is simply a direction that intersects the flange portion 32 (imaginary surface S). In this embodiment, the mounting portion 312, which is the outer portion of the first end portion 31a, protrudes in a direction perpendicular to the imaginary surface S of the flange portion 32. It should be noted that in this specification, the separation direction D can also be referred to as the thickness direction of the sheet 2 or the thickness direction of the clamping member 4. It should be noted that, in this specification, regarding the through portion 31 (or the first end portion 31a), when referred to as "inner side" and "outer side," the inner circumferential portion of the through portion 31 near the axis of the through path 311 is called the inner side, and the outer circumferential portion of the through portion 31 (or the first end portion 31a) opposite to the inner side is called the outer side. Furthermore, regarding the various parts of the fixing device 1, when described as "protruding outwards" or "extending outwards," it means that each part protrudes or extends in a direction from the inner side (inner circumference) of the through portion 31 towards the outer side (outer circumference).

[0033] Regarding the shape and structure of the through portion 31, there are no particular limitations as long as the through portion 31 can be supported on the organism while the through member IS passes through the through portion 31. In this embodiment, as... Figure 1 As shown, the through portion 31 is configured to protrude outward from the organism. Specifically, as... Figure 3 As shown, the through portion 31 is configured such that the axis of the through path 311 is inclined relative to the imaginary surface S of the flange portion 32, but the inclination angle of the axis of the through path 311 is not particularly limited. Alternatively, the through path 311 may be configured to be orthogonal to the imaginary surface S of the flange portion 32.

[0034] It should be noted that, although the illustration is omitted, the through portion 31 may also include a chuck member disposed between the inner wall of the through portion 31 defining the through path 311 and the outer surface of the through member IS, and fastening and holding the outer peripheral surface of the through member IS; and a sealing member for liquid-tightly retaining the through member IS within the through path 311. The chuck member, sealing member, etc., provided between the inner wall of the through portion 31 and the outer surface of the through member IS can be of known structures, therefore detailed description is omitted. It should be noted that the material constituting the through portion 31 is a biocompatible material with predetermined rigidity. For example, titanium, titanium alloys, and other biocompatible and highly corrosion-resistant metallic materials are used as the material constituting the through portion 31.

[0035] In this embodiment, such as Figure 3 As shown, the through portion 31 has a mounting portion 312 on the outer side of the first end portion 31a of the through portion 31, which is configured to mount the clamping member 4. Figure 3 As shown, the mounting portion 312 is separated from the flange portion 32 in the separation direction D (thickness direction of the sheet 2), and has an engaging step portion 312a protruding outward from the first end 31a (in a direction intersecting the separation direction D) and a retaining groove 312b provided in the separation direction D between the engaging step portion 312a and the flange portion 32. In this embodiment, in addition, the side of the through portion 31 opposite to the flange portion 32 in the separation direction D (the side opposite to the engaging step portion 312a) Figure 3 The portion on the upper side of the engagement step 312a is configured to be one size smaller than the engagement step 312a in the protruding direction. In this case, when the sheet 2 and the clamping member 4 are installed in the retaining groove 312b from the second end 31b side, the sheet 2 and the clamping member 4 can be easily moved to the position of the engagement step 312a. Figure 8 (The location shown).

[0036] The engaging step portion 312a is configured to engage at least partially with the inner periphery 4a of the clamping member 4 described later in the separation direction D, thus functioning as an anti-disengagement portion of the clamping member 4. In this embodiment, as... Figure 3 As shown, the engaging step portion 312a protrudes from the outer side of the first end portion 31a of the through portion 31 relative to the portion adjacent to the engaging step portion 312a in the separation direction D. In this embodiment, the engaging step portion 312a is configured as a protruding strip that continuously protrudes in the circumferential direction of the through portion 31. However, the engaging step portion may not be continuous in the circumferential direction of the through portion 31, but may protrude partially.

[0037] In this embodiment, the plate 2 and the clamping member 4 are configured such that when they are mounted on the outside of the first end portion 31a of the through portion 31 (see reference 31) Figure 1 and Figure 9 When the sheet 2 is pressed by the clamping member 4 in the thickness direction of the sheet 2, the clamping member 4 engages with the engaging step portion 312a, as will be described in detail later. In this case, by the reaction force applied from the sheet 2 to the clamping member 4 when the clamping member 4 presses the sheet 2, the surface of the clamping member 4 opposite to the sheet 2 is pressed to the engaging step portion 312a. Therefore, the installation of the sheet 2 and the clamping member 4 is completed simply by placing the sheet 2 and the clamping member 4 on the outside of the first end 31a of the through portion 31 (retaining groove 312b). Therefore, temporary fixation of the sheet 2 and the clamping member 4 can be performed, and the assembly of the fixing device 1 becomes simple. In addition, the sheet 2 itself does not engage with the engaging step portion 312a, but is restricted from disengaging from the retaining groove 312b by the clamping member 4 with a predetermined width that engages with the engaging step portion 312a. Therefore, even without increasing the outward protrusion of the engaging step portion 312a, the plate 2 can be stably held in the retaining groove 312b using the clamping member 4 with a predetermined width. Thus, in the device body 3, it is not necessary to increase the protrusion of the engaging step portion 312a or otherwise complicate the structure of the device body 3.

[0038] like Figure 1 and Figure 9 As shown, the retaining groove 312b is a groove provided for the inner periphery 4a of the clamping member 4 to be positioned when the clamping member 4 is engaged with the engaging step portion 312a. The length of the retaining groove 312b in the separation direction D is not particularly limited, as long as it is sufficient to clamp the sheet 2 using the clamping member 4 and the flange portion 32. In this embodiment, the length of the retaining groove 312b in the separation direction D is configured to be shorter than the combined thickness of the thickness of the clamping member 4 and the sheet 2.

[0039] The flange 32, together with the clamping member 4, clamps the sheet 2. In this embodiment, the flange 32 and the through portion 31 are integrally formed. To promote cell growth and fixation, the flange 32 may also be formed as a porous material. Additionally, as... Figure 2 As shown, the flange portion 32 may also have multiple holes H. The multiple holes H can be holes for mounting the filament 5 (described later), holes for cell invasion by appropriately setting the size of the holes H without using the filament 5, or holes for cell invasion by mounting the filament 5.

[0040] like Figures 1-3 As shown, the flange portion 32 extends outward along the outer periphery of the first end portion 31a of the through portion 31 by a predetermined width. The shape of the flange portion 32 is not particularly limited, as long as it can clamp the sheet body 2 together with the clamping member 4. In this embodiment, as... Figure 2 and Figure 4As shown, the flange portion 32 is formed in a generally elliptical shape (generally oblong shape). However, the flange portion 32 can be appropriately modified according to the outer peripheral shape of the through portion 31 and the shape of the sheet 2.

[0041] like Figure 1 and Figure 9 As shown, the flange portion 32 has a first surface 32a that becomes the outer side of the body when the fixing device 1 is installed on the organism. In addition, the flange portion 32 has a second surface 32b on the side opposite to the first surface 32a.

[0042] like Figure 1 As shown, the first surface 32a is the surface of the flange 32 facing outward (opposite to the in vivo side) when installed in a living organism (wall-like tissue T). The first surface 32a contacts the sheet 2 when the sheet 2 penetrates the through portion 31. Figure 1 and Figure 9 As shown, the first surface 32a clamps the sheet 2 together with the clamping member 4.

[0043] In this embodiment, the first surface 32a supports the inner peripheral portion of the sheet 2, which is a portion of a predetermined width from the inner peripheral edge 2a, in the direction from the inner peripheral edge 2a to the outer peripheral edge 2b of the sheet 2. Thus, the inner peripheral portion of the sheet 2 overlapping with the first surface 32a retains its shape using the first surface 32a, and the shape of the portion of the sheet 2 extending outward from the first surface 32a is also stabilized to some extent. Therefore, during procedures such as installing the fixation device 1 on a wall-like tissue T, the shape of the thin sheet 2 is stable, making it easier for the physician to operate the fixation device 1.

[0044] The amount of protrusion of the flange portion 32 (the amount of overlap with the sheet body 2) is not particularly limited, as long as it can stably support the sheet body 2. For example, the amount of protrusion of the flange portion 32 (the amount of overlap with the sheet body 2) can be set to 20% or more, preferably 30% or more, and more preferably 40% or more, of the length from the inner peripheral edge 2a to the outer peripheral edge 2b of the sheet body 2. In this case, the shape of the sheet body 2 is stabilized by supporting the sheet body 2 with a predetermined width or more on the flange portion 32. Alternatively, the amount of protrusion of the flange portion 32 (the amount of overlap with the sheet body 2) can be set to 70% or less, preferably 60% or less, and more preferably 50% or less, of the length from the inner peripheral edge 2a to the outer peripheral edge 2b of the sheet body 2. In this case, the width of the soft portion of the sheet body 2 is ensured to be a predetermined amount, making it easy to configure the sheet body 2 according to the curvature of the wall-like tissue T.

[0045] In addition, in this embodiment, such as Figures 7-10As shown, the first surface 32a of the flange portion 32 has an inclined surface, which is inclined toward the outer side of the body as it moves from the outer periphery of the flange portion 32 toward the outer periphery of the through portion 31 while the fixing device 1 is installed on the organism. In this case, when the sheet 2 is arranged on the first surface 32a formed by the inclined surface, as... Figures 7-9 As shown, the portion of sheet 2 extending outward from the flange 32 is inclined at an angle along the inclined surface. Therefore, the portion extending from the flange 32 of sheet 2 is not planar (parallel to the imaginary surface S), but slightly curved into a skirt shape. Consequently, the portion of sheet 2 extending from the flange 32 is easily positioned along the surface of the curved wall-like tissue T, suppressing the formation of gaps between the wall-like tissue T and sheet 2.

[0046] In this embodiment, such as Figure 9 and Figure 10 As shown, the aforementioned retaining groove 312b has a curved portion protruding toward the center of the through portion 31 (the axis of the through path 311), and this curved portion is connected to the inclined surface of the flange portion 32. Because the inclined surface of the flange portion 32 and the curved surface of the retaining groove 312b form a continuous and smooth surface, the abrupt change in the angle of the sheet 2 inclined along the inclined surface of the flange portion 32 at the boundary between the flange portion 32 and the retaining groove 312b can be suppressed. Therefore, the sheet 2 easily follows the surfaces of the inclined surface of the flange portion 32 and the curved surface of the retaining groove 312b. This suppresses the generation of gaps between the sheet 2 and the inclined surface of the flange portion 32 and the curved surface of the retaining groove 312b. Furthermore, as... Figure 10 As shown by the double-dotted line, for example, when the sheet 2 is compressed by the clamping member 4 in the thickness direction of the sheet 2, causing the inner periphery 2a of the sheet 2 to shift (expand) toward the bottom of the retaining groove 312b, the inner periphery 2a of the sheet 2 can be smoothly avoided.

[0047] The second surface 32b is the portion that faces the wall-shaped tissue T together with the sheet 2 when the fixing device 1 is positioned on the wall-shaped tissue T. The second surface 32b can be composed of a smooth plane or a curved surface. In this embodiment, as... Figure 9 As shown, the second surface 32b of the flange portion 32 is formed by a curved surface that protrudes outward from the outer periphery of the flange portion 32 toward the inward side when the fixation device 1 is installed on the organism. In this case, when the fixation device 1 is positioned on the wall-like tissue T, the second surface 32b is positioned along the curved wall-like tissue T, suppressing the formation of a gap between the wall-like tissue T and the second surface 32b. Unlike the soft sheet 2, the flange portion 32 is mostly a metal product with high rigidity that does not deform in a way that follows the surface of the wall-like tissue T, but because the second surface 32b is formed by a curved surface, it can easily adhere tightly along the curvature of the skin surface.

[0048] In addition, in this embodiment, such as Figure 9 As shown, the curved surface of the second surface 32b is inclined in the same direction as the inclined surface of the first surface 32a of the flange portion 32. In this case, the skirt-shaped curved portion of the sheet 2 extending from the flange portion 32 forms a continuous curved surface with the curved surface of the second surface 32b of the flange portion 32. As a result, it can be disposed more closely along the surface of the curved wall-like tissue T.

[0049] The clamping member 4 can be installed on the outside of the first end 31a of the through portion 31, and clamps the sheet body 2 together with the flange portion 32. More specifically, as Figure 1 As shown, the clamping member 4, together with the flange portion 32, clamps the inner circumferential portion of the sheet 2 in the thickness direction, holding the sheet 2 in place. The material constituting the clamping member 4 is a biocompatible material with predetermined rigidity. For example, biocompatible and highly corrosion-resistant metallic materials such as titanium or titanium alloys are used as the material constituting the clamping member 4.

[0050] The clamping member 4 is configured as a separate component from the device body 3 and is installed in the through portion 31 of the device body 3. In this embodiment, as... Figure 2 and Figure 5 As shown, the clamping member 4 is formed in a ring shape with an opening 41 in the center. Figure 8 and Figure 9 As shown, the clamping member 4 is installed on the device body 3 through the through-hole 31 via the opening 41, and together with the flange 32, clamps the sheet 2 that first passes through the through-hole 31.

[0051] In this embodiment, the clamping member 4 is flexible and configured to elastically deform in a manner that allows it to pass over the engaging step portion 312a in the separation direction D. The clamping member 4 is configured to elastically return to its original position after passing over the engaging step portion 312a, thereby engaging the inner periphery 4a of the clamping member 4 with the engaging step portion 312a (see reference). Figure 9 and Figure 10 In this embodiment, the clamping member 4 is formed as a flat plate, which is easily elastically deformable. The clamping member 4 is configured such that, when installed in the through portion 31, as... Figure 9 and Figure 10 As shown, the inner peripheral edge 4a is disposed in the retaining groove 312b and engages with the engaging step portion 312a in the separation direction D.

[0052] The size of the clamping member 4 can be appropriately varied depending on the purpose of using the fixing device 1, the size of the sheet 2, and the size of the through portion 31. Preferably, the amount of protrusion of the clamping member 4 from the outside of the first end 31a (retaining groove 312b) when it is inserted through the through portion 31 is the same as that of the flange portion 32 (for example, 80% to 120% of the protrusion of the flange portion 32). In this case, the sheet 2 is clamped by the flange portion 32 and the clamping member 4 with a predetermined contact width of equal length, thereby stably holding the sheet 2.

[0053] The shape of the clamping member 4 can be appropriately changed according to the shape of the sheet 2 and the through portion 31. In this embodiment, such as Figure 2 and Figure 5 As shown, the overall shape of the clamping member 4 is an ellipse (approximately oblong) with an opening 41 on the inner side. In this embodiment, a plurality of recesses 42 are provided along the circumferential direction of the clamping member 4 on its outer peripheral edge 4b ​​and inner peripheral edge 4a, in a direction that connects the outer peripheral edge 4b ​​and inner peripheral edge 4a of the clamping member 4. By providing the recesses 42 in the clamping member 4, the clamping member 4 can be easily flexed, making installation into the through portion 31 easier. More specifically, as... Figure 5 As shown, the recess 42 is formed by cutting it into a roughly semi-circular shape. In the inner periphery 4a, the spacing between a pair of adjacent recesses 42, 42 in the circumferential direction is smaller than the width of the recess 42 in the circumferential direction. In this case, the portion of the inner periphery 4a of the clamping member 4 that hooks onto the engaging step 312a is less than half of the inner periphery 4a of the clamping member 4. Therefore, the resistance when passing over the engaging step 312a during the installation of the clamping member 4 is reduced, and the clamping member 4 can be installed more easily. In addition, by providing the recess 42 on the outer periphery 4b of the clamping member 4, cells enter the recess 42 on the outer periphery 4b, thereby suppressing the movement of the fixing device 1 in the circumferential direction of the clamping member 4. Therefore, the fixing device 1 can be stably held in the wall-like tissue T. In addition, in this embodiment, the recess 42 formed on the outer periphery 4b of the clamping member 4 and the recess 42 formed on the inner periphery 4a are arranged at a position offset in the circumferential direction. Specifically, as Figure 5 As shown, the recess 42 formed on the outer periphery 4b is located between a pair of recesses 42, 42 formed on the inner periphery 4a. Therefore, the clamping member 4 is easily bent, and thus, for example, when the fixing device 1 is installed on a wall-like tissue T, the clamping member 4 easily follows the movement of the through member IS, such as the drive line, thus preventing the clamping member 4 from detaching from the through portion 31. Furthermore, the portion of the inner periphery 4a between the inner periphery 4a and the adjacent recess 42 is convex, thus, compared to a structure without recesses 42, the depth of engagement with the engaging step portion 312a can be increased, making it less likely for the clamping member 4 to detach from the through portion 31.

[0054] It should be noted that the recess can be provided only on the inner periphery 4a of the clamping member 4, or only on the outer periphery 4b. In addition, the recess can also have a polygonal shape such as a triangle or a quadrilateral.

[0055] In addition, the recess 42 makes the clamping member 4 easy to elastically deform, so that, as will be described later, when the clamping member 4 is sewn by the linear body 5, the clamping member 4 deforms and can fit tightly in such a way that the gap between the clamping member 4 and the sheet 2 disappears.

[0056] Clamping component 4 can also be as follows Figure 6 As shown in the modified example, there are no recesses on the inner perimeter 4a and the outer perimeter 4b. Additionally, as... Figure 5 and Figure 6 As shown, the clamping member 4 may also have a through hole 43 extending through the clamping member 4 along its thickness direction. When the clamping member 4 is provided with a through hole 43, as... Figure 1 As shown, when the clamping member 4 is disposed on the wall-shaped tissue T, the cells invade the interior of the through hole 43, which can stably fix the fixation device 1.

[0057] In this embodiment, with the clamping member 4 installed in the retaining groove 312b, as follows: Figure 11 As shown, the hole H of the device body 3 is configured to overlap with a portion of the through hole 43 of the clamping member 4 and a portion of the recess 42 of the inner peripheral edge 4a of the clamping member 4 in the separation direction D. In other words, the hole H of the device body 3 and the through hole 43 of the clamping member 4 are connected in the separation direction D, and the hole H of the device body 3 and the recess 42 of the inner peripheral edge 4a of the clamping member 4 are also connected in the separation direction D. Therefore, cells invading from the hole H of the device body 3 can easily invade the through hole 43 of the clamping member 4 or the recess 42 of the inner peripheral edge 4a of the clamping member 4 via the sheet 2. Furthermore, cells invading from the through hole 43 of the clamping member 4 or the recess 42 of the inner peripheral edge 4a of the clamping member 4 can easily invade the hole H of the device body 3 via the sheet 2. This makes it easier to stably fix the fixing device 1. Furthermore, since the thread-like body 5 inserted from the hole H of the device body 3 can easily pass through the recess 42 of the inner periphery 4a of the clamping member 4, the suturing of the thread-like body 5 becomes easier. The amount of overlap between the hole H of the device body 3, the through hole 43 of the clamping member 4, and the recess 42 of the inner periphery 4a of the clamping member 4 in the separation direction D can be appropriately set within a range where cells can easily invade and bacteria cannot easily invade. It should be noted that, in this embodiment, as Figure 11 As shown, the hole H of the main body 3 is provided in the circumferential direction of the clamping member 4 at positions corresponding to the plurality of recesses 42 provided on the inner peripheral edge 4a of the clamping member 4. Additionally, as... Figure 11As shown, the through hole 43 of the clamping member 4 is arranged in the circumferential direction of the clamping member 4 at positions corresponding to the multiple holes H of the device body 3 respectively.

[0058] In the fixing device 1 of this embodiment, such as Figure 1 and Figure 9 As shown, the sheet 2 extends through the first end 31a of the through portion 31 and is held by the first surface 32a of the flange portion 32 and the clamping member 4. That is, when the sheet 2 is installed in the through portion 31 of the device body 3, the sheet 2 is held by being clamped by the first surface 32a of the flange portion 32 and the clamping member 4. Therefore, when the sheet 2 is held in the device body 3, the portion of the device body 3 facing inward (e.g., the second surface 32b side of the flange portion 32) will not have fastening members such as nuts protruding as in Patent Document 1. As a result, the formation of steps on the inward-facing surface of the fixing device 1 can be suppressed. Therefore, it is possible to suppress the formation of steps between the sheet 2 and the flange portion 32 and the wall-like tissue T, which would make it difficult for cells to adhere.

[0059] Next, the assembly method of the fixing device 1 will be described. It should be noted that the following description is only an example, and the structure of the fixing device 1 is not limited by the following description.

[0060] First, such as Figure 2 and Figure 3 As shown, a device body 3 with a through portion 31 and a flange portion 32 is prepared. Next, as... Figure 7 As shown, a sheet 2 with an opening 21 is inserted through the through portion 31 from the second end 31b side, and is arranged such that the inner peripheral portion of the sheet 2 overlaps with the first surface 32a of the flange portion 32. Next, as... Figure 8 As shown, the clamping member 4 passes through the through portion 31 from the second end 31b side. The clamping member 4 from... Figure 8 The hook, as shown, is pressed toward the flange 32 while being engaged with the step 312a. When the clamping member 4 is pressed toward the flange 32, it elastically deforms, thus passing over the step 312a. Therefore, as... Figure 1 and Figure 9 As shown, the sheet 2 is clamped by the clamping member 4 and the first surface 32a of the flange 32. This prevents the formation of a portion protruding inwards relative to the second surface 32b of the flange 32 on the inner side of the sheet 2, and prevents the formation of a step on the inner side of the fixing device 1. Therefore, as... Figure 1 As shown, when the fixation device 1 is positioned relative to the wall-like tissue T, it can suppress the formation of steps between the sheet 2 and the flange 32 and the wall-like tissue T that would make it difficult for cells to attach. Therefore, the sheet 2 adheres tightly to the wall-like tissue T, allowing cells to easily invade the sheet 2, thus promoting cell growth and fixation.

[0061] In this embodiment, when the clamping member 4 passes over the engaging step portion 312a, under the pressing force of the clamping member 4 toward the flange portion 32, the sheet 2 is pressed toward the flange portion 32 and compressed. Figure 10 (The state of the double-dotted line). The clamping member 4, which crosses the engaging step 312a, receives a reaction force from the compressed piece 2 toward the engaging step 312a (in Figure 10 (The reaction force is upward). Therefore, clamping member 4 is subjected to an upward reaction force. Figure 10 When pressed upwards, it engages with the engaging step portion 312a. Therefore, there is no need to use fastening components such as screws and nuts to fix the sheet body 2, and the sheet body 2 can be stably held with a simple structure.

[0062] When the clamping member 4 compresses the sheet 2 in the thickness direction, the inner periphery 2a of the sheet 2 deforms in a manner that retracts toward the bottom of the retaining groove 312b (see reference). Figure 10 (The double-dotted line). In this embodiment, as described above, the retaining groove 312b has a curved surface, forming a smooth surface that is continuous with the inclined surface of the first surface 32a of the flange portion 32. Therefore, as Figure 10 As shown, the inner periphery 2a of the sheet 2 is able to face the bottom of the retaining groove 312b (towards) Figure 10 Smoothly retreat (to the upper right of the middle).

[0063] It should be noted that, as a variation of the above implementation method, such as... Figure 11 As shown, the sheet 2 can also be fixed by suturing with the thread-like body 5 while being clamped between the first surface 32a of the flange 32 and the clamping member 4. In this case, the sheet 2 can be fixed more stably, and the sutured thread-like body 5 forms a small uneven structure at the contact point between the fixation device 1 and the wall-like tissue T without creating a large step. The uneven structure formed by the thread-like body 5 acts as a resistance to the relative movement between the fixation device 1 and the wall-like tissue T, suppressing the positional displacement of the fixation device 1 relative to the wall-like tissue T. In addition, small spaces are formed between the thread-like body 5 and the clamping member 4, between the thread-like body 5 and the sheet 2, and between the thread-like body 5 and the flange 32, allowing cells to enter these small spaces, thereby enabling early fixation between the fixation device 1 and the wall-like tissue T. It should be noted that... Figure 11 For ease of illustration, the illustration of the main body 3 of the device has been omitted.

[0064] Like sheet 2, the filament 5 is composed of a non-absorbable material with biocompatibility. The non-absorbable material with biocompatibility constituting the filament 5 can be the same material used for medical sutures. The material constituting the filament 5 can be, for example, at least one selected from the group consisting of polyurethane resin, polyamide resin, polylactic acid resin, polyolefin resin, polyester resin, fluoropolymer resin, urea resin, phenolic resin, epoxy resin, polyimide resin, acrylic resin, and methacrylic resin, and their derivatives, and is preferably stretched polytetrafluoroethylene (ePTFE). Furthermore, to further promote the growth / attachment of wall-like tissue T cells, the filament 5 is preferably porous.

[0065] Regarding the thickness of the thread 5, there is no particular limitation as long as it can form a concave-convex structure that acts as a resistance to relative movement of the target part in the extension direction of the sheet 2. For example, a thread with a diameter of 0.1 mm to 0.5 mm, preferably 0.1 mm to 0.3 mm, and more preferably 0.2 mm can be used.

[0066] The thread-like body 5 is sewn onto the sheet 2 with a predetermined sewing pattern. Regarding the sewing pattern of the thread-like body 5, there are no particular limitations as long as it can form an uneven structure that resists relative movement of the sheet 2 relative to the target area in the extending direction. In this embodiment, as... Figure 11 As shown, the clamping member 4 is alternately sewn from the recess 42 of the inner periphery 4a to the recess 42 of the outer periphery 4b, and from the recess 42 of the outer periphery 4b to the recess 42 of the inner periphery 4a. Furthermore, the thread 5 is sewn at the recess 42 in a manner that, in the thickness direction of the sheet 2, it penetrates the sheet 2 and the hole H of the flange 32. Specifically, the thread 5 penetrating the hole H of the flange 32, the sheet 2, and the recess 42 of the inner periphery 4a of the clamping member 4 is sewn in a manner that, it penetrates the recess 42 of the outer periphery 4b of the clamping member 4 and the sheet 2, and the thread 5 is sewn to the hole H adjacent to the aforementioned hole H of the flange 32. The thread 5 is then sewn to the clamping member 4 using the same steps. It should be noted that the thread-like body 5 can also be sewn onto the portion of the sheet 2 that extends outward from the flange 32 and is not clamped by the clamping member 4. It should also be noted that when the sheet 2 is sewn onto the thread-like body 5 while being clamped by the clamping member 4 and the flange 32, the engaging step portion 312a may not be required. Furthermore, the sewing steps are not limited to the order and direction described above.

[0067] The embodiments of the present invention have been described above, but the present invention is not limited to the above embodiments. It should be noted that the above embodiments mainly describe an invention having the following structure.

[0068] (1) A fixing device comprising: Porous sheets composed of non-absorbent materials with biocompatibility; The main body of the device includes a through portion through which a through-member extending from inside the organism to outside the organism can pass; and A ring-shaped clamping member, wherein, The main body of the device has a flange portion that extends outward by a predetermined width along the outer periphery of the first end of the through portion, which is the inner side of the body when the fixing device is installed in the organism. The clamping member can be mounted on the outside of the first end of the through portion. The flange portion has a first surface that becomes the outer side of the body when the fixing device is installed on the organism. The sheet extends through the first end of the through portion and is held by the first surface of the flange and the clamping member.

[0069] (2) The fixing device according to (1), wherein the first surface of the flange has an inclined surface, the inclined surface being inclined toward the outside of the body as the fixing device is installed on the organism from the outer periphery of the flange toward the outer periphery of the through portion.

[0070] (3) The fixing device according to (1) or (2), wherein the second surface of the flange portion opposite to the first surface is formed by a curved surface that protrudes outward from the outer periphery of the flange portion toward the inner side while the fixing device is installed on the organism.

[0071] (4) The fixing device according to any one of (1) to (3), wherein a plurality of recesses are provided along the circumferential direction of the clamping member at the outer periphery and / or inner periphery of the clamping member, the plurality of recesses being recessed in the direction connecting the outer periphery and inner periphery of the clamping member.

[0072] (5) The fixing device according to any one of (1) to (4), wherein the sheet is fixed by the linear body while being clamped between the first surface of the flange and the clamping member.

[0073] Explanation of reference numerals in the attached figures 1. Fixing device; 2. Sheet; 2a. Inner periphery of the sheet; 2b. Outer periphery of the sheet; 21. Opening; 3. Main body of the device; 31. Through part; 31a. First end; 31b. Second end; 311. Through path; 311a. First opening; 311b. Second opening; 312. Mounting part; 312a. Engaging step part; 312b. Retaining groove; 32. Flange part; 32a. First surface; 32b. Second surface; 4. Clamping member; 4a. Inner periphery of the clamping member; 4b. Outer periphery of the clamping member; 41. Opening; 42. Recess; 43. Through hole; 5. Linear body; D. Separation direction; H. Hole; IS. Through member; S. Imaginary surface of the flange part; T. Wall-like structure.

Claims

1. A fixing device comprising: Porous sheets composed of non-absorbent materials with biocompatibility; The main body of the device includes a through portion through which a through-member extending from inside the organism to outside the organism can pass; and A ring-shaped clamping member, wherein, The main body of the device has a flange portion that extends outward by a predetermined width along the outer periphery of the first end of the through portion, which is the inner side of the body when the fixing device is installed in the organism. The clamping member can be mounted on the outside of the first end of the through portion. The flange portion has a first surface that becomes the outer side of the body when the fixing device is installed on the organism. The sheet extends through the first end of the through portion and is held by the first surface of the flange and the clamping member.

2. The fixing device according to claim 1, wherein, The first surface of the flange has an inclined surface that is inclined toward the outside of the body as it moves from the outer periphery of the flange toward the outer periphery of the through portion, while the fixing device is installed on the organism.

3. The fixing device according to claim 1, wherein, The second surface of the flange, opposite to the first surface, is formed by a curved surface that protrudes outward from the body as the fixing device is installed on the organism, moving inward from the outer periphery of the flange.

4. The fixing device according to claim 1, wherein, A plurality of recesses are provided along the circumferential direction of the clamping member on the outer periphery and / or the inner periphery, and the plurality of recesses are recessed in the direction connecting the outer periphery and the inner periphery of the clamping member.

5. The fixing device according to any one of claims 1 to 4, wherein, The sheet is fixed by a linear body while it is held between the first surface of the flange and the clamping member.

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