Fixing device

Abstract

To provide a fixing device capable of liquid-tightly holding an insertion member with a simple constitution.SOLUTION: A fixing device 1 of the present invention includes: a body 2 including a cylindrical portion 21 having an internal space S into which an insertion member IS is inserted; a seal member 3 made of an elastic material and disposed between the outer periphery of the insertion member IS and the inner surface of the cylindrical portion 21 in the internal space S of the cylindrical portion 21; and a lock member 4 locked to the cylindrical portion 21 in a state where the seal member 3 disposed in the internal space S is compressed in an axial direction D1 of the insertion member IS. The seal member 3 is formed in a cylindrical shape having an insertion member insertion portion 31 through which the insertion member IS passes, and the fixing device 1 further includes at least one rigid portion 5 disposed between the outer periphery of the seal member 3 and the inner surface of the insertion member insertion portion 31.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] The present invention relates to a fixation device. [Background technology]

[0002] BACKGROUND ART For example, a fixing device such as that shown in Patent Document 1 is disclosed as a fixing tool for fixing an inserting member such as a medical tube or a driveline to the skin when the inserting member is led from inside the living body to outside the living body.

[0003] In the fixing device of Patent Document 1, an insertion member is inserted into a main body attached to the skin and is held liquid-tight by multiple members. Specifically, the fixing device includes a main body, a pair of half-split contact members that sandwich the outer periphery of the insertion member, a nut-shaped movement restricting member fastened to the main body, an inner seal disposed between the movement restricting member and the insertion member, and an outer seal disposed between the movement restricting member and the main body. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Publication No. 2020-81537 Summary of the Invention [Problem to be solved by the invention]

[0005] Although the above-described fixing device can hold the insertion member in a liquid-tight state, there is a demand for a simpler structure that can hold the insertion member in a liquid-tight state.

[0006] Therefore, an object of the present invention is to provide a fixing device that can hold an insertion member liquid-tight with a simple configuration. [Means for solving the problem]

[0007] The fixing device of the present invention is a fixing device that fixes an inserting member that is inserted into the wall-like tissue of a living organism and is attached to the living organism, and the fixing device comprises: a main body with a tubular portion having an internal space through which the inserting member is inserted; a sealing member made of an elastic material that is arranged in the internal space of the tubular portion between the outer periphery of the inserting member and the inner surface of the tubular portion; and a locking member that locks the sealing member arranged in the internal space to the tubular portion in a state where the sealing member is compressed in the axial direction of the inserting member, the sealing member being configured in a tubular shape with an inserting member insertion portion for passing the inserting member through, and the fixing device further comprises at least one rigid portion that is arranged between the outer periphery of the sealing member and the inner surface of the inserting member insertion portion.

[0008] Furthermore, the fixing device of the present invention is a fixing device that fixes an inserting member to be inserted into wall-like tissue of a living organism and is attached to the living organism, and the fixing device comprises: a main body with a tubular portion having an internal space through which the inserting member is inserted; a sealing member made of an elastic material that is arranged in the internal space of the tubular portion between the outer periphery of the inserting member and the internal surface of the tubular portion; and a locking member that locks the sealing member arranged in the internal space to the tubular portion in a state where the sealing member is compressed in the axial direction of the inserting member, and the sealing member is configured in a tubular shape with an inserting member insertion portion for passing the inserting member through, and has a thick portion that is long in a direction perpendicular to the axial direction and a thin portion that is shorter in distance than the thick portion in the direction perpendicular to the axial direction. [Effects of the Invention]

[0009] According to the fixing device of the present invention, the insertion member can be held liquid-tight with a simple structure. [Brief explanation of the drawings]

[0010] [Figure 1] FIG. 1 is a side view of a fixation device according to one embodiment of the present invention. [Figure 2] FIG. 2 is a perspective view of the fixation device of FIG. 1; [Figure 3] FIG. 2 is an exploded perspective view of the fixation device of FIG. 1. [Figure 4]FIG. 2 is an axial view of the fixing device of FIG. 1. [Figure 5] FIG. 5 is a cross-sectional view taken along line VV in FIG. [Figure 6] 2 is a view of a main body used in the fixing device of FIG. 1 as seen in the axial direction. [Figure 7] FIG. 7 is a perspective view of the main body of FIG. 6. [Figure 8] FIG. 8 is a cross-sectional view taken along line VIII-VIII in FIG. 6. [Figure 9] FIG. 2 is a perspective view of a seal member used in the fixing device of FIG. 1. [Figure 10] FIG. 4 is a partial enlarged view of the cylindrical portion with the seal member attached, as viewed in the axial direction. [Figure 11] 10A and 10B are schematic diagrams showing modified examples of the sealing member. [Figure 12] FIG. 10 is a schematic view showing another modified example of the sealing member. [Figure 13] FIG. 10 is a partial enlarged view of a cylindrical portion of a fixing device according to a modified example of the present invention, with a seal member attached, as viewed in the axial direction. DETAILED DESCRIPTION OF THE INVENTION

[0011] Hereinafter, a fixing device according to one embodiment of the present invention will be described with reference to the drawings. Note that the embodiment described below is merely an example, and the fixing device of the present invention is not limited to the following embodiment.

[0012] In this specification, the expressions "perpendicular to A" and similar expressions do not refer only to a direction that is completely perpendicular to A, but also refer to a direction that is approximately perpendicular to A. In this specification, the expressions "parallel to B" and similar expressions do not refer only to a direction that is completely parallel to B, but also refer to a direction that is approximately parallel to B. In this specification, the expressions "C-shape" and similar expressions do not refer only to a perfect C-shape, but also refer to a shape that visually resembles a C-shape (approximately a C-shape).

[0013] 1 and 5, the fixing device 1 of this embodiment fixes an inserting member IS that is inserted into wall-like tissue T of a living organism, and is attached to the living organism. In this embodiment, the fixing device 1 is fixed to the wall-like tissue T of the living organism by being embedded at a predetermined position and a predetermined depth in the wall-like tissue T with the inserting member IS inserted therein, as shown in FIGS.

[0014] In this specification, the term "living body" refers to the body of a human or non-human animal. The term "wall-like tissue" refers to any tissue, such as a wall or membrane, of a living body having a predetermined thickness through which the insertion member IS is inserted. Specifically, the wall-like tissue refers to various tissues in a living body, such as the skin (epidermis, dermis, subcutaneous tissue), muscle layer, and tissues constituting various organs, as well as layers formed by combining these. In this embodiment, the wall-like tissue T through which the insertion member IS is inserted is a tissue including the skin (epidermis, dermis, subcutaneous tissue) and muscle layer. The fixing position (embedding position) in the wall-like tissue T to which the fixing device 1 is fixed can be changed as appropriate depending on the body shape, etc. of the patient (living body) to which the fixing device 1 is fixed.

[0015] The use of the fixing device 1 is not particularly limited as long as it can fix the inserting member IS inserted into the wall-like tissue T of a living body and be attached to the living body. For example, the fixing device 1 can be used for a skin button (cuff member) through which the inserting member IS is inserted. In this embodiment, the fixing device 1 is used when inserting a driveline (inserting member IS) used in a medical device implanted in the human body (e.g., an artificial organ such as a ventricular assist device (VAD) or an artificial lung) through the abdominal wall-like tissue T and leading the driveline from inside to outside the human body. The driveline led outside the body is fixed at a predetermined position in the abdominal wall-like tissue T via the fixing device 1, as shown in FIGS. 1 and 5 .

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

[0017] The internal structure of the insertion member IS is not particularly limited. For example, the insertion member IS may have a cooling water circulation passage for circulating cooling water between the artificial organ inside the body and the pressure pump outside the body, and a power cable for connecting the artificial organ inside the body to an external power source. The insertion member IS may be configured to have only a power cable, or may be configured to have only a cooling water circulation passage. The insertion member IS may also be configured to have components having functions other than those described above, or may be configured as a hollow member (tube) with no internal components. When used as a hollow member connecting the inside and outside of the body, the insertion member IS may be used to deliver a therapeutic drug from outside the body to a treatment site inside the body.

[0018] As shown in Figures 1 to 5, the fixing device 1 comprises a main body 2 having a tubular portion 21 with an internal space S (see Figure 3) through which the inserting member IS is inserted, a sealing member 3 made of an elastic material that is arranged in the internal space S of the tubular portion 21 between the outer periphery of the inserting member IS and the inner surface of the tubular portion 21, and a locking member 4 that locks the sealing member 3 arranged in the internal space S to the tubular portion 21 while compressing it in the axial direction D1 (see Figure 1) of the inserting member IS.

[0019] Regarding the components of the fixing device 1 (e.g., the cylindrical portion 21, the sealing member 3, the locking member 4, the rigid portion 5 described later, etc.), the direction in which the inserting member IS extends when inserted into the fixing device 1 is referred to as the axial direction D1 of the inserting member IS. Furthermore, the axis passing through the center of the inserting member IS when inserted is referred to as the axis X (see FIG. 1). Regarding the components of the fixing device 1, the direction perpendicular to the axial direction D1 is referred to as the direction away from the axis X or the radial direction D2 (see FIG. 1). While only one radial direction D2 is shown in the drawings for ease of illustration, the radial direction is not limited to the illustrated direction and may be any direction radiating from the axis X (the radial direction or diameter direction of a circle centered on the axis X). Regarding the components of the fixing device 1, the direction in which the inserting member IS rotates around the axis X (the direction around the axis X) is referred to as the circumferential direction D3 (see FIG. 1).

[0020] The main body 2 is a base portion of the fixing device 1, into which the inserting member IS is inserted. In this embodiment, as shown in Figs. 1 to 8, the main body 2 includes a tubular portion 21 having an inner space S through which the inserting member IS is inserted, and a fixing portion 22 that is attached to a living body. In this embodiment, the tubular portion 21 and the fixing portion 22 are integrally formed, but the tubular portion and the fixing portion may also be formed separately from each other.

[0021] The fixing portion 22 is a portion that is fixed to the wall-like tissue T of a living body. Specifically, the fixing portion 22 is fixed around a hole (not shown) formed in the wall-like tissue T for inserting the insertion member IS (see FIGS. 1 and 5). The shape of the fixing portion 22 is not particularly limited as long as it can fix the fixing device 1 to the wall-like tissue T of a living body. In the present embodiment, as shown in FIGS. 2 to 4, 6 and 7, the fixing portion 22 is formed in a flange shape so as to surround the end of the tubular portion 21 of the main body 2, and the flange-shaped fixing portion 22 is embedded under the skin (wall-like tissue T) and thereby fixed to the skin (see FIGS. 1 and 5).

[0022] The material of the fixing part 22 is not particularly limited as long as it can fix the fixing device 1 to the wall-like tissue T of a living body. The fixing part 22 is made of, for example, a biocompatible material. For example, a biocompatible, highly corrosion-resistant metal material such as titanium or a titanium alloy can be used as the material for the fixing part 22. The surface of the fixing part 22 may be subjected to a surface treatment to improve adhesion to the wall-like tissue T. Alternatively, the fixing part (for example, when the tubular part and the fixing part are separate bodies) may be made of a sheet body made of a non-absorbable material with biocompatibility. In this case, the non-absorbable material making up the fixing part may be the same material as that used as a medical sheet inside the body or at a wound site. When the fixing part is a sheet body, it is preferable that the fixing part be made of a flexible material. In this case, the fixing part can follow the movement of the wall-like tissue T, such as the skin. When the fixing part is made of a flexible material, the material constituting the fixing part 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, methacrylic resin, and derivatives thereof, and preferably expanded polytetrafluoroethylene (ePTFE).

[0023] The cylindrical portion 21 is a portion of the main body 2 through which the inserting member IS is inserted. As shown in FIGS. 3 and 5 to 8, the cylindrical portion 21 has an internal space S through which the inserting member IS is inserted. In this embodiment, the cylindrical portion 21 is configured to support the inserting member IS, such as a driveline, in an inserted state via a seal member 3 (see FIG. 5). The cylindrical portion 21 is configured from a biocompatible material that has a predetermined rigidity capable of supporting the inserting member IS in an inserted state. The material from which the cylindrical portion 21 is configured is not particularly limited, but is preferably a biocompatible, corrosion-resistant metal material such as titanium or a titanium alloy, or a biocompatible, tough resin material such as polyether ether ketone (PEEK). The overall shape of the cylindrical portion 21 is not particularly limited as long as it can accommodate the inserting member IS. In this embodiment, the cylindrical portion 21 is formed in a substantially cylindrical shape. Specifically, the cylindrical portion 21 extends at an angle in a direction non-perpendicular to the extending direction of the flange-shaped fixing portion 22. The cylindrical portion 21 can be appropriately set depending on the type of inserting member IS to be inserted, the part of the wall-like tissue T of the living body to which the fixing device 1 is attached, etc., and the cylindrical portion 21 may extend perpendicularly from the fixing portion 22.

[0024] As shown in FIGS. 5 and 8, the cylindrical portion 21 has a first end portion 21a, which is an end region inside the body of a living organism, and a second end portion 21b, which is an end region outside the body of a living organism. As shown in FIGS. 5 and 8, the cylindrical portion 21 has a first opening OP1 provided on the first end portion 21a side (inside the body) and a second opening OP2 provided on the second end portion 21b side (outside the body). In this embodiment, an internal space S is formed between the first opening OP1 and the second opening OP2 (see FIG. 8). Note that the internal space S is the entire space between the first opening OP1 and the second opening OP2, and includes spaces other than the space through which the inserting member IS passes (e.g., a space in which the seal member 3 is housed, a space around the inserting member IS, etc.). In this embodiment, the inserting member IS is led into the body from the first opening OP1 of the first end portion 21a. Furthermore, the inserting member IS is led out from the second opening OP2 of the second end portion 21b toward the outside of the living body. As shown in Figures 1, 2 and 5, a locking member 4 is attached to the second end portion 21b.

[0025] In this embodiment, as shown in Figures 5 to 8, the cylindrical portion 21 includes a housing portion 211 that houses the seal member 3. Furthermore, as shown in Figure 5, the cylindrical portion 21 has an insertion portion 212, through which the inserting member IS is inserted, with a radial gap between the outer periphery of the inserting member IS and the insertion portion 212, on one side (the side toward the living body when attached to the living body) in the axial direction D1 of the cylindrical portion 21 relative to the housing portion 211. Furthermore, as shown in Figures 5 and 8, the cylindrical portion 21 has a locking member attachment portion 213 on the other side (the side away from the living body when attached to the living body) in the axial direction D1 of the cylindrical portion 21 relative to the housing portion 211.

[0026] The accommodating portion 211 is a portion of the cylindrical portion 21 in which the seal member 3 is accommodated and disposed (see FIG. 5 ). When the seal member 3 is accommodated in the axial direction D1 as described below, the accommodating portion 211 comes into close contact with the outer surface of the seal member 3. This prevents bodily fluids, such as blood, from passing through the seal member 3 in the axial direction D1. The length of the accommodating portion 211 in the axial direction D1 is not particularly limited as long as it can accommodate the seal member 3 in a state where it can be compressed in the axial direction D1. The accommodating portion 211 may be configured to accommodate the entire seal member 3 in the axial direction D1, or may be configured to accommodate only a portion of the seal member 3. In this embodiment, as shown by the two-dot chain line in FIG. 5 , the length of the accommodating portion 211 in the axial direction D1 is shorter than the length of the seal member 3 before compression in the axial direction D1 so that the other end (the end on the locking member 4 side) of the seal member 3 in the axial direction D1 protrudes from the accommodating portion 211.

[0027] The inner surface of the storage portion 211 defines a space in which the seal member 3 is accommodated. The shape of the inner surface of the storage portion 211 is not particularly limited as long as it can closely contact the outer surface of the seal member 3 and prevent bodily fluids such as blood from passing through the position of the seal member 3 in the axial direction D1. In this embodiment, the inner shape of the storage portion 211 and the outer surface shape of the seal member 3 correspond to each other. Note that "corresponding shapes" means that the inner shape of the storage portion 211 and the outer surface shape of the seal member 3 are identical or similar to each other to such an extent that they can closely contact each other in a state in which the seal member 3 is compressed and deformed in the axial direction D1, as described below. Therefore, before the seal member 3 is compressed and deformed in the axial direction D1, the inner shape of the storage portion 211 and the outer surface shape of the seal member 3 may be slightly different shapes.

[0028] As shown in FIGS. 5 to 8 , in this embodiment, the accommodation portion 211 has an axial abutment portion A1 against which one end face 3a (see FIG. 5) of the seal member 3 in the axial direction D1 (opposite the locking member 4) abuts when the seal member 3 is accommodated in the accommodation portion 211. The axial abutment portion A1 positions the seal member 3 by abutting against one end face 3a of the seal member 3 in the axial direction D1. As will be described later, the axial abutment portion A1 also functions as a support portion that supports the end face 3a of the seal member 3 when the seal member 3 is compressed in the axial direction D1. The shape and structure of the axial abutment portion A1 are not particularly limited as long as it is configured to abut against at least a portion of the end face 3a of the seal member 3 in the axial direction D1. In this embodiment, the axial abutment portion A1 is configured by an abutment surface extending perpendicular to the axial direction D1. More specifically, the axial abutment portion A1 is formed by a flat surface that abuts against a portion of the end face 3a of the sealing member 3 on the outer side in the radial direction D2 (a portion of the protrusion 342 (see Figures 9 and 10) described later) (in Figure 6, the outline of the sealing member 3 is shown by a dotted line).

[0029] As will be described in detail later, as shown in FIG. 10 , the accommodating portion 211 includes a circumferential abutment portion A2 that abuts against the seal member 3 in the circumferential direction of the inserting member IS. The circumferential abutment portion A2 is configured to face a portion of the seal member 3 in the circumferential direction D3 and to engage with the portion of the seal member 3 in the circumferential direction D3. As a result, even if a force that rotates the seal member 3 in the circumferential direction D3 is applied to the seal member 3, as will be described later, the portion of the seal member 3 engages with the circumferential abutment portion A2 in the circumferential direction D3, restricting the seal member 3 from rotating in the circumferential direction D3 relative to the accommodating portion 211. In the present embodiment, the circumferential abutment portion A2 is configured to abut against a protruding portion 342 of the seal member 3, and the circumferential abutment portion A2 engages with the protruding portion 342 of the seal member 3 in the circumferential direction D3, restricting the seal member 3 from rotating in the circumferential direction relative to the accommodating portion 211.

[0030] 6 and 10, in this embodiment, the circumferential contact portion A2 extends in a direction that includes a component of the radial direction D2 so as to engage with the protruding portion 342 of the seal member 3 in the circumferential direction D3. The direction in which the circumferential contact portion A2 extends (the angle with respect to the radial direction D2) is not particularly limited as long as it can abut and engage with the protruding portion 342 of the seal member 3 in the circumferential direction D3. In this embodiment, the circumferential contact portion A2 is formed by a curved surface, but it may also be formed by a flat surface or a combination of a flat surface and a curved surface. 6 and 10, in this embodiment, the accommodation portion 211 has a first circumferential abutment portion A21 that engages with the protrusion 342 of the seal member 3 when a force in one rotational direction is applied to the seal member 3 in the circumferential direction D3, and a second circumferential abutment portion A22 that engages with the protrusion 342 of the seal member 3 when a force in the other rotational direction is applied to the seal member 3 in the circumferential direction D3. The first circumferential abutment portion A21 and the second circumferential abutment portion A22 are connected by a radial abutment portion A3. The radial abutment portion A3 extends along the circumferential direction D3 and engages with the outer surface of the seal member 3 in the radial direction D2 when the seal member 3 is compressed in the axial direction D1. The first circumferential contact portion A21, the radial contact portion A3, and the second circumferential contact portion A22 define a recess (see FIGS. 6 and 10) in which one protrusion 342 of the seal member 3 is accommodated. In this embodiment, the accommodation portion 211 has a plurality of recesses (three in this embodiment) that accommodate each of the plurality of protrusions 342 of the seal member 3 (three in this embodiment). One recess of the accommodation portion 211 is connected to another recess adjacent to that recess in the circumferential direction D3 by a connecting portion C (see FIGS. 6 and 10). In this embodiment, the plurality of recesses that accommodate the protrusions 342 (thick-walled portions 344) described below and the plurality of connecting portions C that are convex inward and connect the plurality of recesses are configured with curved surfaces. In this case, as will be described later, when the sealing member 3 is compressed in the axial direction D1, the material of the sealing member 3 that is compressed and deformed tends to move smoothly along the curved surface from the protrusion 342 (thick-walled portion 344) to the thin-walled portion 343 (see Figure 10).Therefore, as will be described later, the gap between the inserting member IS and the inner surface of the accommodating portion 211 can be more easily sealed by the thin-walled portion 343 of the seal member 3, thereby improving the sealing performance of the seal member 3.

[0031] In the present embodiment, the accommodating portion 211 has a shape having a plurality (three) of recesses so as to accommodate the plurality (three) of protruding portions 342 (thickened portions 344) of the seal member 3 (in other words, a shape in which a plurality (three) of protruding spaces extend outward in the radial direction D2 from a central space through which the inserting member IS passes), but the shape of the accommodating portion is not limited to the shapes shown in FIGS. 6 and 10 as long as it can accommodate the seal member 3. For example, if the seal member 3 has only one protruding portion (thickened portion 344), the accommodating portion may have a shape having one recess. Therefore, the space defined by the inner surface of the accommodating portion can have a shape in which one or more protruding spaces extend outward in the radial direction D2 from a central space through which the inserting member IS passes. More specifically, the space defined by the inner surface of the accommodating portion may have a keyhole shape in which one protruding space (recess) extends outward in the radial direction D2 from a central space through which the inserting member IS passes, or a cross shape (see FIG. 12), gear shape, or star shape in which multiple protruding spaces (recesses) extend. Furthermore, the space defined by the inner surface of the accommodating portion may have a polygonal shape such as a circle, an ellipse (see FIG. 11), a triangle, a square, a pentagon, or a hexagon, in addition to the above shapes, or a shape that is a combination of the above shapes or other shapes.

[0032] The locking member mounting portion 213 is a portion of the cylindrical portion 21 to which the locking member 4 is attached. In this embodiment, the locking member mounting portion 213 engages with the locking member 4 in the axial direction D1 and prevents the locking member 4 from coming off the cylindrical portion 21. As a result, even if the locking member 4 receives a reaction force from the seal member 3 in the axial direction D1 (in the direction opposite to the compression direction) when the locking member 4 compresses the seal member 3 in the axial direction D1, the locking member 4 is held at a predetermined position relative to the cylindrical portion 21. The shape and structure of the locking member mounting portion 213 are not particularly limited as long as the locking member mounting portion 213 can engage with the locking member 4 in the axial direction D1 and prevent the locking member 4 from coming off the cylindrical portion 21. In this embodiment, as shown in FIGS. 3 and 5 , the locking member mounting portion 213 is configured as an engagement recess having a female thread FS into which the locking member 4 having a male thread MS is threadedly engaged. Specifically, as shown in Figures 3, 5, 7, and 8, the locking member mounting portion 213 is formed in a cylindrical shape large enough to allow a portion of the locking member 4 to be inserted therein, and has a female thread FS on its inner surface. However, the locking member mounting portion can be modified as appropriate depending on the structure of the locking member, and may have a structure different from that shown in the drawings. For example, if the locking member is snap-fitted to the locking member mounting portion, the locking member mounting portion may be configured to have, instead of a female thread, an engaged portion that engages with the engaging claw of the locking member in the axial direction D1.

[0033] In this embodiment, as shown in FIGS. 5 to 8 , the cylindrical portion 21 has a stop portion ST that abuts against a portion of the locking member 4 in the axial direction D1 when the locking member 4 is moved in the axial direction D1 relative to the locking member attaching portion 213, stopping the locking member 4 at a predetermined position in the axial direction D1. By providing the stop portion ST on the cylindrical portion 21, when the locking member 4 engages with the locking member attaching portion 213, a portion of the locking member 4 (in this embodiment, one end of the locking member 4 in the axial direction D1) abuts against the stop portion ST, stopping the locking member 4 at a predetermined axial position. This allows the amount of compression of the seal member 3 compressed by the locking member 4 to be constant, as will be described later. This prevents the amount of compression of the seal member 3 from changing depending on factors such as the degree of tightening by the user of the fastening device 1. This prevents a decrease in sealing performance due to insufficient compression.

[0034] The locking member 4 is locked to the cylindrical portion 21 in a state in which the seal member 3 disposed in the internal space S is compressed in the axial direction D1. In this embodiment, when the locking member 4 is locked to the cylindrical portion 21, it moves relative to the cylindrical portion 21 in the axial direction D1. As will be described in detail later, in this embodiment, when the locking member 4 moves relative to the cylindrical portion 21, the locking member 4 presses the seal member 3 in the axial direction D1, compressing the seal member 3 in the axial direction D1 (in FIG. 5, the position of the seal member 3 before compression is indicated by a two-dot chain line, and the seal member 3 indicated by a solid line in FIG. 5 is in a compressed state). Due to the deformation of the seal member 3 when it is compressed in the axial direction D1, the inserting member IS inserted into the seal member 3 is held by the seal member 3.

[0035] The shape and structure of the locking member 4 are not particularly limited as long as the locking member 4 is configured to lock the sealing member 3 disposed in the internal space S to the cylindrical portion 21 in a state where the sealing member 3 is compressed in the axial direction D1. In this embodiment, the locking member 4 is configured as a fastening member having a male thread MS on its outer periphery, as shown in Figures 3 and 5. However, as described above, the locking member 4 may have another structure, such as having an engaging portion such as an engaging claw, and being configured to be snap-fitted to the locking member mounting portion 213 having an engaged portion.

[0036] As shown in FIG. 5 , the locking member 4 has a pressing portion 41 configured to press the end face 3b of the sealing member 3 (the other end face in the axial direction D1, which is opposite to the one end face 3a in the axial direction D1). In this embodiment, the pressing portion 41 is configured by the end face of the locking member 4 that can contact the end face 3b of the sealing member 3 (in FIG. 5 , depending on the cutting position of the cross section, it appears as if the pressing portion 41 and the end face 3b of the sealing member 3 are not in contact, but in reality, a part of the pressing portion 41 is in contact with the end face 3b of the sealing member 3). The shape and structure of the pressing portion are not particularly limited as long as it can press the end face 3b of the sealing member 3. In this embodiment, the pressing portion 41 is configured to be in surface contact with the end face 3b of the sealing member 3, but it may be configured to be in localized contact with the end face 3b of the sealing member 3, such as point contact or line contact.

[0037] In this embodiment, as shown in FIG. 5, the locking member 4 has a contact portion 42 that comes into contact with the stop portion ST of the cylindrical portion 21 in the axial direction D1. In this embodiment, the contact portion 42 is provided at one end of the locking member 4 in the axial direction D1. Specifically, as shown in FIG. 5, the contact portion 42 is configured as a protrusion (an annular protrusion in this embodiment) that protrudes in the axial direction D1 from the outer periphery of one end of the locking member 4 in the axial direction D1. In this embodiment, the contact portion 42 is provided so as to protrude in the axial direction D1 relative to the pressing portion 41; however, the end face of the locking member 4 may be formed flat without a protrusion, and both the pressing portion and the contact portion may be configured by the flat end face of the locking member 4.

[0038] The seal member 3 seals the gap that occurs between the outer surface of the inserting member IS and the inner surface of the cylindrical portion 21. Specifically, the seal member 3 is disposed between the outer surface of the inserting member IS and the inner surface of the cylindrical portion 21, thereby preventing bodily fluids such as blood from moving from one side to the other in the axial direction D1 of the seal member 3. The seal member 3 is configured to be compressed in the axial direction D1 by the lock member 4. The seal member 3 is compressed and deformed in the axial direction D1, thereby coming into close contact with the outer surface of the inserting member IS and the inner surface of the cylindrical portion 21, thereby preventing bodily fluids such as blood from moving from one side to the other in the axial direction D1 of the seal member 3.

[0039] The sealing member 3 is made of an elastic material that is elastically deformable. The material that makes up the sealing member 3 is not particularly limited as long as it can seal the gap that occurs between the outer surface of the insertion member IS and the inner surface of the tubular portion 21, but for example, a biocompatible elastic material such as silicone rubber is preferably used.

[0040] As shown in FIGS. 3, 5, and 9, the seal member 3 is configured in a cylindrical shape having an inserting member insertion portion 31 for passing the inserting member IS therethrough. In this embodiment, the inserting member insertion portion 31 is a through-hole that penetrates the seal member 3 in the axial direction D1. The inserting member insertion portion 31 is configured so that a cross section taken perpendicular to the axial direction D1 is circular. When the inserting member IS is passed through the inserting member insertion portion 31, the inserting member IS is surrounded by the seal member 3. Note that, in this embodiment, as shown in FIGS. 3, 9, and 10, the seal member 3 is provided with a notch 33 that communicates from the outer surface of the seal member 3 to the inserting member insertion portion 31 so that the inserting member IS can be moved from the outer surface of the seal member 3 in the radial direction D2 to the inserting member insertion portion 31. This allows the seal member 3 to be easily attached to the inserting member IS by moving the inserting member IS in a direction perpendicular to the axial direction D1 (radial direction D2) relative to the seal member 3 (or by moving the seal member 3 in the radial direction D2 relative to the inserting member IS). Note that the seal member may be attached to the inserting member IS from the end of the inserting member IS without providing a cutout portion in the seal member.

[0041] In this embodiment, the length of the seal member 3 in the axial direction D1 is longer than the length of the accommodation portion 211 in the axial direction D1, and when the seal member 3 is placed in the accommodation portion 211, a portion of the seal member 3 protrudes from the accommodation portion 211 (see the two-dot chain line in FIG. 5 ). In this embodiment, the portion of the tubular portion 21 between the axial abutment portion A1 and the stop portion ST in the axial direction D1 is configured as the accommodation portion 211, and when the seal member 3 is placed in the accommodation portion 211, a portion of the seal member 3 protrudes from the stop portion ST to the other side in the axial direction D1 (protruding beyond the stop portion ST and out of the accommodation portion 211), as shown by the two-dot chain line in FIG. 5 . In this embodiment, this protruding portion is pressed in the axial direction D1 by the locking member 4, thereby compressing the seal member 3 in the axial direction D1. Note that the seal member 3 may not protrude from the accommodation portion 211, but the locking member 4 may protrude into and enter the accommodation portion 211, thereby compressing the seal member 3 in the axial direction D1 by the locking member 4.

[0042] In the present embodiment, the seal member 3 has an accommodating hole 32 that accommodates the rigid portion 5, which will be described later, as shown in FIGS. 5, 9, and 10. The accommodating hole 32 extends in the seal member 3 along the axial direction D1. The shape and structure of the accommodating hole 32 are not particularly limited as long as it can accommodate the rigid portion 5 so that the rigid portion 5 can exhibit the effects described later. In the present embodiment, the accommodating hole 32 is configured as a through-hole that penetrates the seal member 3 in the axial direction D1, as shown in FIG. 5. However, the accommodating hole may not penetrate in the axial direction D1 (for example, it may be configured to be open on only one side or only the other side in the axial direction D1) as long as it can accommodate the rigid portion 5. The position at which the accommodating hole 32 is provided is not particularly limited. In the present embodiment, the accommodating hole 32 is provided in the thick-walled portion 344 of the seal member 3 at a position such that the distance in the radial direction D2 from the accommodating hole 32 to the inserting member insertion portion 31 and the distance in the radial direction D2 from the accommodating hole 32 to the outer surface of the seal member 3 are substantially equal. In addition, when no rigid portion is provided as in the modified example shown in FIG. 13, no receiving hole is provided either.

[0043] The overall shape of the seal member 3 is not particularly limited as long as it can seal the gap that occurs between the outer surface of the inserting member IS and the inner surface of the tubular portion 21 and allows for the arrangement of the rigid portion 5. In this embodiment, as shown in FIGS. 9 and 10 , the seal member 3 includes an inner circumferential portion 341 configured to surround the outer periphery of the inserting member IS, and a protruding portion 342 that protrudes outward from the inner circumferential portion 341 in a direction (radial direction) perpendicular to the axial direction D1 of the seal member 3. The inner circumferential portion 341 is a portion that is provided with a predetermined thickness in the radial direction D2 around the inserting member insertion portion 31. The inner circumferential portion 341 surrounds the inserting member IS when the inserting member IS is inserted into the seal member 3. 10, the seal member 3 has thick portions 344 that have a long distance L4 in a direction perpendicular to the axial direction D1 (radial direction D2), and thin portions 343 that have a shorter distance L3 in a direction perpendicular to the axial direction D1 (radial direction D2) than the thick portions 344. The thick portions 344 are portions of the seal member 3 that are relatively thicker in the radial direction D2 than the other portions (thin portions 343) in the circumferential direction D3. The thin portions 343 are portions of the seal member 3 that are relatively thinner in the radial direction D2 than the other portions (thick portions 344) in the circumferential direction D3. In this embodiment, the thin portions 343 are provided between the thick portions 344 in the circumferential direction D3. In this embodiment, the thick portion 344 is a portion where the protruding portion 342 is provided, and strictly speaking, the thick portion 344 is a portion where the inner circumferential portion 341 and the protruding portion 342 are joined together at a position where the protruding portion 342 is provided in the circumferential direction D3. In this embodiment, the thin portion 343 is a part of the inner circumferential portion 341 located between the pair of protruding portions 342 in the circumferential direction D3.

[0044] The protrusion 342 is a portion that protrudes outward from the inner circumferential portion 341 in the radial direction D2. In this embodiment, as shown in FIGS. 9 and 10 , a plurality of (three) protrusions 342 are provided at predetermined intervals in the circumferential direction D3. The protrusions 342 are configured to abut against the circumferential abutment portion A2 of the accommodating portion 211 in the circumferential direction D3. As a result, when a force that rotates the seal member 3 in the circumferential direction D3 is applied in the accommodating portion 211, the protrusions 342 and the circumferential abutment portion A2 engage with each other, restricting the rotation of the seal member 3. Therefore, when the fixing device 1 is in use, the insertion member IS, which is disposed in close contact with the inner side of the seal member 3, is prevented from being subjected to a twisting force about the axis X. In particular, when the locking member 4 is a fastening member, the seal member 3 is subjected to a force that rotates the seal member 3 in the circumferential direction D3 from the locking member 4. In response to this force, the protruding portion 342 engages with the circumferential abutment portion A2 of the accommodating portion 211 in the circumferential direction D3, thereby preventing the seal member 3 from rotating around the axis X. Therefore, twisting of the inserting member IS around the axis X is prevented, and changes in the position and angle of the inserting member IS extending into the body, which are caused by the twisting of the inserting member IS, are prevented.

[0045] 9 and 10 , the protrusion 342 includes a first contact portion 342a that contacts the first circumferential contact portion A21 of the accommodating portion 211, a second contact portion 342b that contacts the second circumferential contact portion A22 of the accommodating portion 211, and a third contact portion 342c that contacts the radial contact portion A3 of the accommodating portion 211. The first contact portion 342a and the second contact portion 342b are connected in the circumferential direction D3 by the third contact portion 342c. The first contact portion 342a extends at an angle and size that is disposed along the first circumferential contact portion A21 of the accommodating portion 211. The second contact portion 342b extends at an angle and size that is disposed along the second circumferential contact portion A22 of the accommodating portion 211. The third contact portion 342c extends at an angle and with a size that allows it to be disposed along the radial contact portion A3 of the accommodation portion 211.

[0046] The shape of the seal member 3 corresponds to the shape of the housing portion, such as the shape of the housing portion of the present embodiment and the shape of the housing portion of the modified example. Therefore, the seal member 3 can have one or more protrusions that protrude outward in the radial direction D2 from an inner periphery configured to surround the outer periphery of the inserting member IS. More specifically, the seal member may have a keyhole shape with one protrusion that protrudes outward in the radial direction D2 from the inner periphery, or a cross shape (see FIG. 12), gear shape, or star shape with multiple protrusions. In addition to the above shapes, the seal member may also have a polygonal shape, such as a circle, an ellipse (see FIG. 11), a triangle, a square, a pentagon, or a hexagon, or a shape that combines the above shapes or other shapes.

[0047] In this embodiment, the fixing device 1 further includes at least one rigid portion 5 disposed between the outer periphery of the sealing member 3 and the inner surface of the inserting portion 31 for the inserting member, as shown in Figures 3, 5, and 10. The rigid portion 5 is not an essential component, and the sealing member 3 may not be provided with a rigid portion, as in the modified example shown in Figure 13. The modified example shown in Figure 13 has the same configuration as the embodiment shown in Figures 1 to 10, except that it does not have a rigid portion or a receiving hole, and the matters described with reference to Figures 1 to 10 can also be applied to the modified example.

[0048] As shown in FIGS. 5 and 10 , the rigid portion 5 is disposed in the seal member 3 at a predetermined position between the outer periphery of the seal member 3 and the inner surface of the inserting member insertion portion 31. The rigid portion 5 may be molded integrally with the seal member 3, or may be detachably attached to the seal member 3. In this embodiment, the rigid portion 5 is detachably attached to the seal member 3 and configured to be inserted into the accommodating hole 32 of the seal member 3 during use. In this embodiment, the rigid portion 5 is accommodated in the accommodating hole 32 so as to be movable relative to the seal member 3 in the axial direction D1. In this case, when the seal member 3 is compressed and deformed in the axial direction D1, the rigid portion 5 does not move integrally with the seal member 3. Therefore, the deformation of the seal member 3 is not restricted by the rigid portion 5, and the seal member 3 is free to deform. This facilitates close contact between the seal member 3 and the inserting member IS and the accommodating portion 211. Furthermore, if the rigid portion 5 is not sufficiently pressed into the accommodating hole 32, the rigid portion 5 can be pressed by the locking member 4 and moved to a predetermined position.

[0049] The rigid portion 5 is made of a rigid material having higher rigidity than the seal member 3. It is preferable that the rigid portion 5 has a predetermined rigidity that does not substantially deform due to the pressure applied to the rigid portion 5 from the seal member 3 when the seal member 3 is compressed in the axial direction D1. The material that makes up the rigid portion 5 is not particularly limited as long as it has the predetermined rigidity, but for example, a metal material that is biocompatible and highly corrosion-resistant, such as titanium, a titanium alloy, or polyether ether ketone, can be used.

[0050] In this embodiment, as shown in FIGS. 5 and 10 , a rigid portion 5 is provided between the outer periphery of the seal member 3 and the inner surface of the inserting member insertion portion 31. As a result, when the seal member 3 is compressed in the axial direction D1 by the locking member 4, the portion of the seal member 3 between the rigid portion 5 and the inner surface of the inserting member insertion portion 31 has a hard wall where the rigid portion 5 has high rigidity. The rigid portion 5 is less likely to deform toward the rigid portion 5, but deforms toward the inserting member IS inserted in the inserting member insertion portion 31. In other words, when the seal member 3 is compressed in the axial direction D1 by the locking member 4, the rigid portion 5 functions as a core that displaces a portion of the seal member 3 toward the inserting member IS. Therefore, if a gap is generated between the inserting member insertion portion 31 and the outer surface of the inserting member IS, the seal member 3 preferentially deforms toward the inserting member IS, closing the gap and adhering to the inserting member IS. This allows the fixing device 1 to maintain a liquid-tight seal with a simple configuration without complicating the configuration.

[0051] Furthermore, when the seal member 3 is compressed in the axial direction D1 by the locking member 4, the portion of the seal member 3 between the rigid portion 5 and the inner surface of the accommodating portion 211 has a rigid wall where the highly rigid rigid portion 5 forms a hard wall, making it difficult to deform toward the rigid portion 5 and deforming so as to fill the gap between the inner surface of the accommodating portion 211 and the outer surface of the seal member 3. In other words, when the seal member 3 is compressed in the axial direction D1 by the locking member 4, the rigid portion 5 functions as a core that displaces a portion of the seal member 3 toward the inner surface of the accommodating portion 211. Therefore, if a gap occurs between the outer surface of the seal member 3 and the inner surface of the accommodating portion 211, the seal member 3 deforms preferentially to fill the gap, closing the gap and adhering closely to the inner surface of the accommodating portion 211. As a result, the gap between the outer surface of the seal member 3 and the inner surface of the accommodating portion 211 can be filled with a simple configuration without complicating the configuration of the fixing device 1, and the seal member 3 can be held liquid-tight in the accommodating portion 211.

[0052] 10 , the seal member 3 has a thin portion 343 and a thick portion 344. The thick portion 344 has higher rigidity than the thin portion 343, and the thin portion 343 is more easily deformed than the thick portion 344. As a result, the thick portion 344 serves as a rigid wall, and the seal member 3 is less likely to deform from the thin portion 343 toward the thick portion 344. The thin portion 343 deforms to fill the gap between the seal member 3 and the inserting member IS and the gap between the inner surface of the accommodating portion 211 and the outer surface of the seal member 3. In other words, when the seal member 3 is compressed in the axial direction D1 by the locking member 4, the thick portion 344 functions as a core that displaces the thin portion 343 toward the inserting member IS and the inner surface of the accommodating portion 211. Therefore, if a gap occurs between the seal member 3 and the inserting member IS and accommodating portion 211, the seal member 3 will deform preferentially to fill the gap, closing the gap and coming into close contact with the inner surfaces of the inserting member IS and accommodating portion 211. This makes it possible to maintain the seal member 3 liquid-tight with the inserting member IS and accommodating portion 211 with a simple configuration without complicating the configuration of the fixing device 1. This effect can be achieved not only in the embodiments shown in FIGS. 1 to 12 in which a rigid portion 5 is provided, but also in a modified example shown in FIG. 13 in which no rigid portion is provided.

[0053] Furthermore, in this embodiment, a portion of the seal member 3 between the rigid portion 5 and the inserting member IS (the portion enclosed by the dimension line L2 in FIG. 10) also functions as a thin-walled portion. Therefore, in addition to the thin-walled portion 343 provided between the pair of protruding portions 342 in the circumferential direction D3, the protruding portions 342 also have portions that function as thin-walled portions, so that the inserting member IS is pressed inward from more points in the circumferential direction D3. Therefore, the holding force and sealing performance of the inserting member IS are further improved.

[0054] In this embodiment, the thick-walled portion 344 extends along the axial direction D1 of the seal member 3 and is provided over the entire length of the seal member 3 in the axial direction D1. In this case, the thin-walled portion 343 of the seal member 3 easily adheres to the inserting member IS and the inner surface of the accommodating portion 211 over the entire length of the axial direction D1. For example, if only a thin-walled portion is provided over the entire length of the seal member in the axial direction D1 (i.e., if the seal member is thin over the entire length of the axial direction D1 and does not have a thick-walled portion), there is no portion (thick-walled portion) that maintains the shape of the thin-walled portion and guides the direction of deformation. In this case, when the seal member is compressed in the axial direction D1 by the locking member 4, only the end region of the seal member that comes into contact with the locking member 4 deforms. Therefore, in a configuration without a thick-walled portion, for example, the center portion of the seal member in the axial direction D1 and the end region opposite the locking member 4 in FIG. 5 are less likely to deform, and the seal member's adhesion to the inserting member IS and the inner surface of the accommodating portion 211 is weakened. In this embodiment, the thick-walled portion 344 is provided throughout the entire axial direction D1 of the sealing member 3, allowing the thin-walled portion 343 of the sealing member 3 to adhere closely to the inner surface of the inserting member IS and the accommodating portion 211 throughout the entire axial direction D1.

[0055] Furthermore, in this embodiment, the rigid portion 5 is used to compress the seal member 3 in the axial direction D1 by the locking member 4, thereby providing a liquid-tight seal between the inserting member IS and the seal member 3 and between the seal member 3 and the accommodating portion 211. Therefore, before the seal member 3 is compressed in the axial direction D1 by the locking member 4, that is, before the locking member 4 is attached to the locking member attaching portion 213, when moving the seal member 3 in the axial direction D1 along the inserting member IS or when placing the seal member 3 in the accommodating portion 211, the seal member 3 can be easily moved in the axial direction D1. This makes it possible to facilitate the assembly work of the fixing device 1.

[0056] In this embodiment, a total of three rigid portions 5 are provided, but the number of rigid portions 5 can be changed as appropriate depending on the shape and structure of the seal member 3. In this embodiment, the fixing device 1 has multiple rigid portions 5 arranged at a distance from each other in the circumferential direction D3 of the inserting member IS. In this case, by arranging multiple rigid portions 5 in the circumferential direction D3 of the inserting member IS, the seal member 3 adheres in a balanced manner around the inserting member IS. In order to obtain uniform liquid-tightness in the circumferential direction D3, it is preferable to provide three or more multiple rigid portions 5 at equal intervals in the circumferential direction D3.

[0057] The shape of the rigid portion 5 can be appropriately changed depending on the shape and structure of the seal member 3, such as the accommodating hole 32 of the seal member 3. In this embodiment, the rigid portion 5 is formed in a substantially cylindrical shape extending in the axial direction D1 as shown in FIGS. 3 and 5 , but may have other shapes, such as a polygonal pillar or a plate. In this embodiment, both ends of the rigid portion 5 in the axial direction D1 are formed to have curved surfaces, such as hemispherical shapes. In this case, the rigid portion 5 can be easily inserted into the accommodating hole 32 of the seal member 3. Note that the cross section of the rigid portion 5 perpendicular to the axial direction D1 may be larger than the cross section of the accommodating hole 32, so that the rigid portion 5 is press-fit into the accommodating hole 32. In this case, the rigid portion 5 is less likely to come off when assembled to the seal member 3. Alternatively, the cross section of the rigid portion 5 perpendicular to the axial direction D1 may be smaller than the cross section of the accommodating hole 32, so that a clearance is provided between the outer surface of the rigid portion 5 and the accommodating hole 32. In this case, the rigid portion 5 can be smoothly inserted into the accommodating hole 32 of the seal member 3. The length of the rigid portion 5 in the axial direction D1 is preferably a length that does not cause the rigid portion 5 to be compressed in the axial direction D1 when the seal member 3 is compressed in the axial direction D1. In this embodiment, the length of the rigid portion 5 in the axial direction D1 is preferably shorter than the length between the axial contact portion A1 and the pressing portion 41 of the locking member 4 when the seal member 3 is compressed.

[0058] 3, the three rigid portions 5 are provided independently of one another, but for example, the three rigid portions may be connected to one another at their ends in the axial direction D1 to form a single member. The rigid portions may also be provided integrally with the main body 2. For example, the rigid portions may be provided so as to protrude from the axial contact portion A1 of the main body 2 toward the other side in the axial direction D1.

[0059] In this embodiment, as shown in FIG. 10 , the seal member 3 is configured such that the distance L1 in the circumferential direction D3 from the rigid portion 5 to the circumferential contact portion A2 is greater than the distance L2 from the rigid portion 5 to the inner surface of the inserting member insertion portion 31 of the seal member 3. Because the distance L1 in the circumferential direction D3 from the rigid portion 5 to the circumferential contact portion A2 is longer (compared to the distance L2), the rigidity of the portion from the rigid portion 5 to the circumferential contact portion A2 is increased. Therefore, when a rotational force about the axis X is applied to the seal member 3, the seal member 3 is less likely to deform in the circumferential direction D3, making it easier to restrict the rotation of the seal member 3. Furthermore, because the distance L2 (in the radial direction D2) from the rigid portion 5 to the inner surface of the inserting member insertion portion 31 of the seal member 3 is shorter (compared to the distance L1), the rigidity of the portion from the rigid portion 5 to the inner surface of the inserting member insertion portion 31 of the seal member 3 is reduced and the portion is more likely to deform. This allows the seal member 3 to more easily fit tightly to the outer periphery of the inserting member IS, thereby further improving the holding performance and sealing performance of the inserting member IS. In this embodiment, the distance in the radial direction D2 from the rigid portion 5 to the inner surface of the accommodating portion 211 is equal to the distance L2 in the radial direction D2 from the rigid portion 5 to the inner surface of the inserting member insertion portion 31 of the seal member 3 (0.8 to 1.2 times the distance L2, preferably equal). In this case, since the distance in the radial direction D2 from the rigid portion 5 to the inner surface of the accommodating portion 211 is shorter (compared to the distance L1), the rigidity of the portion between the rigid portion 5 and the inner surface of the accommodating portion 211 is lowered and the portion is more likely to deform. This allows the seal member 3 to more easily fit tightly to the inner surface of the accommodating portion 211, thereby further improving the sealing performance of the seal member 3.

[0060] In this embodiment, the locking member 4 is configured so that its inner diameter is larger than the inner diameter of the inserting member insertion portion 31 (the outer diameter of the inserting member IS). This configuration is intended to allow the inserting member IS to be inserted through a portion of the inserting member IS that has a larger diameter than the tubular portion, such as a connector pin connected to a device (not shown) provided at the end of the inserting member IS, such as a driveline. In this manner, if the inner diameter of the locking member 4 is larger than the inner diameter of the inserting member insertion portion 31 (the outer diameter of the inserting member IS) and the locking member 4 does not contact the entire end surface 3b of the seal member 3, when the inserting member IS is pulled in the axial direction D1 (e.g., the upper left direction in FIG. 5 ), a force is applied to the seal member 3 that causes the seal member 3 to deform and move in accordance with the inserting member IS. In this embodiment, the rigid portion 5 provided on the seal member 3 contacts the end surface (pressing portion 41) of the locking member 4, thereby restricting deformation of the seal member 3. Therefore, even if the entire end face 3b of the sealing member 3 is not in contact with the locking member 4, when the inserting member IS is pulled in the axial direction D1, the highly rigid rigid portion 5 can prevent the sealing member 3 from being significantly deformed and damaged, or from coming out of the accommodating portion 211. The inner diameter of the locking member is not particularly limited as long as it can insert the inserting member IS, and may be the same size as the inner diameter of the inserting member insertion portion.

[0061] Next, a method of using the fixing device 1 of this embodiment (a method of fixing the fixing device 1) will be described using an example in which the insertion member is a driveline (hereinafter referred to as driveline IS) and the fixing device 1 is attached to the driveline IS that is led out of the body through a hole provided in the skin (hereinafter referred to as skin T), which is a wall-like tissue. Note that the following description is merely an example, and the fixing device of the present invention is not limited to the following description.

[0062] First, the driveline IS, which has been led out of the body from the skin T, is inserted into the tubular portion 21 of the main body 2 (see FIG. 3). The driveline IS is also inserted into the through-hole of the locking member 4. Once the driveline IS has been inserted into the tubular portion 21 of the main body 2, the main body 2 is placed at a predetermined position on the skin T. Specifically, the fixing portion 22 of the main body 2 is buried under the skin T (see FIGS. 1 and 5).

[0063] Next, as shown in FIG. 3 , the seal member 3 is attached to the driveline IS. In this embodiment, the seal member 3 can be connected to the driveline IS by pressing the seal member 3 toward the driveline IS from the location of the notch 33 of the seal member 3 in a direction perpendicular to the axis X. Next, the seal member 3 is housed in the housing portion 211 of the tubular portion 21. The seal member 3 is housed in the housing portion 211 by moving the seal member 3 in the axial direction D1 along the driveline IS until the end face 3 a of the seal member 3 abuts against the axial abutment portion A1. The rigid portion 5 may be attached to the seal member 3 before or after the seal member 3 is attached to the driveline IS. The rigid portion 5 may be attached to the seal member 3 before or after the seal member 3 is housed in the housing portion 211. When the seal member 3 is accommodated in the accommodation portion 211 and before the lock member 4 is attached to the lock member attachment portion 213, the seal member 3 slightly protrudes from the accommodation portion 211 toward the lock member 4 in the axial direction D1, as indicated by the two-dot chain line in FIG. 5 . In other words, the seal member 3 is not compressed in the axial direction D1, and there is a slight clearance or low adhesion between the inner surface of the seal member 3 and the outer surface of the driveline IS, and between the outer surface of the seal member 3 and the inner surface of the accommodation portion 211. This allows the seal member 3 to be smoothly moved relative to the driveline IS in the axial direction D1 and to be smoothly accommodated in the accommodation portion 211.

[0064] When the seal member 3 is accommodated in the accommodation portion 211, the lock member 4 is moved in the axial direction D1 toward the lock member mounting portion 213 of the cylindrical portion 21. When the lock member 4 reaches the lock member mounting portion 213, the lock member 4 is screwed into the lock member mounting portion 213. As the lock member 4 is screwed into the lock member mounting portion 213, the lock member 4 moves in the axial direction D1 relative to the lock member mounting portion 213, and the pressing portion 41 of the lock member 4 abuts against the end face 3b of the seal member 3. When the lock member 4 is further screwed into the lock member mounting portion 213 in this state, the seal member 3 is compressed in the axial direction D1 by the pressing portion 41 of the lock member 4. When the seal member 3 is compressed in the axial direction D1, the rigid portion 5, which has high rigidity, becomes a hard wall in the portion between the rigid portion 5 and the inner surface of the inserting member insertion portion 31, and deforms toward the driveline IS. Furthermore, the highly rigid rigid portion 5 becomes a hard wall in the area between the rigid portion 5 and the inner surface of the housing portion 211, and deforms to fill the gap between the inner surface of the housing portion 211 and the outer surface of the seal member 3. This causes the seal member 3 to come into close contact with the driveline IS and the housing portion 211, completing the retention of the driveline IS and the sealing of the fixation device 1.

[0065] When the locking member 4 is threaded into the locking member attachment portion 213, the locking member 4 rotates about the axis X while in contact with the end face 3b of the seal member 3, and the seal member 3 receives a rotational force about the axis X from the pressing portion 41 of the locking member 4. The protrusion 342 of the seal member 3 abuts against the circumferential abutment portion A21, thereby restricting the rotation of the seal member 3 against this rotational force. Therefore, although the seal member 3 and the driveline IS are tightly attached by the compression of the seal member 3 in the axial direction D1, the rotation of the seal member 3 about the axis X is restricted. This restricts twisting of the driveline IS about the axis X due to the rotation of the seal member 3, thereby restricting changes in the position and angle of the driveline IS extending inside the body that would result from the twisting of the driveline IS.

[0066] Although the embodiments of the present invention have been described above, the present invention is not limited to the above-described embodiments. Note that the above-described embodiments mainly describe the invention having the following configurations.

[0067] (1) A fixing device that fixes an inserting member that is inserted into wall-like tissue of a living body and is attached to the living body, the fixing device comprising: a main body including a cylindrical portion having an internal space through which the insertion member is inserted; a sealing member made of an elastic material and disposed in the internal space of the cylindrical portion between an outer periphery of the insertion member and an inner surface of the cylindrical portion; a locking member that locks the sealing member disposed in the internal space to the cylindrical portion in a state in which the sealing member is compressed in the axial direction of the inserting member; Equipped with the sealing member is configured in a cylindrical shape having an insertion member insertion portion for passing the insertion member therethrough, The fixation device further comprises: At least one rigid portion is provided between the outer periphery of the sealing member and the inner surface of the inserting portion. Fixation device.

[0068] (2) A fixing device that fixes an inserting member that is inserted into wall-like tissue of a living body and is attached to the living body, the fixing device comprising: a main body including a cylindrical portion having an internal space through which the insertion member is inserted; a sealing member made of an elastic material and disposed in the internal space of the cylindrical portion between an outer periphery of the insertion member and an inner surface of the cylindrical portion; a locking member that locks the sealing member disposed in the internal space to the cylindrical portion in a state in which the sealing member is compressed in the axial direction of the inserting member; Equipped with The sealing member is configured in a cylindrical shape having an inserting member insertion portion for passing the inserting member therethrough, and has a thick-walled portion that is long in a direction perpendicular to the axial direction, and a thin-walled portion that is shorter in distance in the direction perpendicular to the axial direction than the thick-walled portion.

[0069] (3) The seal member includes an inner peripheral portion configured to surround an outer periphery of the insertion member, and a protruding portion protruding outward from the inner peripheral portion in a direction perpendicular to the axial direction of the seal member, the cylindrical portion includes a housing portion that houses the seal member, The accommodating portion includes a circumferential abutment portion that abuts against the protruding portion of the sealing member in the circumferential direction of the inserting member. A fixing device according to (1) or (2).

[0070] (4) The fixing device further comprises: At least one rigid portion is disposed in the thick portion. The fixing device according to any one of (1) to (3).

[0071] (5) The fixing device includes at least one rigid portion disposed between an outer periphery of the sealing member and an inner surface of the inserting portion for the inserting member, A fixing device according to any one of (1) to (4), wherein the circumferential distance L1 from the rigid portion to the circumferential abutment portion is greater than the distance L2 from the rigid portion to the inner surface of the inserting member insertion portion of the sealing member.

[0072] (6) The fixing device according to any one of (1) to (5), wherein the fixing device has a plurality of rigid portions spaced apart from one another in the circumferential direction of the insertion member.

[0073] (7) A fixing device described in any one of (1) to (6), wherein the sealing member has an accommodating hole that accommodates the rigid portion, and the rigid portion is accommodated in the accommodating hole so as to be movable relative to the sealing member in the axial direction. [Explanation of symbols]

[0074] 1 Fixing device 2 Main unit 21 Cylindrical part 21a first end 21b second end 211 Storage Unit 212 Insertion part 213 Locking member mounting portion 22 Fixed part 3 Sealing material 3a, 3b End faces of sealing members 31 Insertion member insertion portion 32 Receiving hole 33 Cutout 341 Inner circumference 342 Protrusion 342a 1st contact part 342b 2nd contact part 342c 3rd contact part 343 Thin-walled section 344 Thick wall part 4 Locking member 41 Pressing section 42 Contact part 5 Rigid part A1 Axial contact part A2 Circumferential contact area A21 First circumferential contact part A22 Second circumferential contact part A3 Radial contact area C connection part D1 Axial direction D2 radial direction D3 Circumferential direction FS female thread IS Insertion Part (Driveline) L1 Circumferential distance from the rigid part to the circumferential contact part L2: Distance from the rigid part to the inner surface of the inserting part of the seal member L3: Distance from the inner surface of the inserting part to the outer surface of the sealing material in the thin-walled part L4: Distance from the inner surface of the inserting part to the outer surface of the sealing material in the thick part MS male thread OP1 1st opening OP2 Second opening S interior space ST stop part T wall-like tissue (skin) X Axis of the insert

Claims

1. A fixing device that fixes an inserting member that is inserted into wall-like tissue of a living body and is attached to the living body, the fixing device comprising: a main body including a cylindrical portion having an internal space through which the insertion member is inserted; a sealing member made of an elastic material and disposed in the internal space of the cylindrical portion between an outer periphery of the insertion member and an inner surface of the cylindrical portion; a locking member that locks the sealing member disposed in the internal space to the cylindrical portion in a state in which the sealing member is compressed in the axial direction of the inserting member; Equipped with the sealing member is configured in a cylindrical shape having an insertion member insertion portion for passing the insertion member therethrough, The fixation device further comprises: At least one rigid portion is provided between the outer periphery of the seal member and the inner surface of the insertion portion for the inserting member. Fixation device.

2. A fixing device that fixes an inserting member that is inserted into wall-like tissue of a living body and is attached to the living body, the fixing device comprising: a main body including a cylindrical portion having an internal space through which the insertion member is inserted; a sealing member made of an elastic material and disposed in the internal space of the cylindrical portion between an outer periphery of the insertion member and an inner surface of the cylindrical portion; a locking member that locks the sealing member disposed in the internal space to the cylindrical portion in a state in which the sealing member is compressed in the axial direction of the inserting member; Equipped with The sealing member is configured in a cylindrical shape having an inserting member insertion portion for passing the inserting member therethrough, and has a thick-walled portion that is long in a direction perpendicular to the axial direction, and a thin-walled portion that is shorter in distance in the direction perpendicular to the axial direction than the thick-walled portion.

3. the seal member includes an inner circumferential portion configured to surround an outer periphery of the insertion member, and a protruding portion protruding outward from the inner circumferential portion in a direction perpendicular to an axial direction of the seal member, the cylindrical portion includes a housing portion that houses the seal member, The accommodating portion includes a circumferential abutment portion that abuts against the protruding portion of the sealing member in the circumferential direction of the inserting member.

3. The fixation device according to claim 1 or 2.

4. The fixation device further comprises: At least one rigid portion is disposed in the thick portion. The fixation device of claim 2 .

5. the fixing device includes at least one rigid portion disposed between an outer periphery of the seal member and an inner surface of the inserting portion; The fixing device according to claim 3 , wherein a distance L1 in the circumferential direction from the rigid portion to the circumferential contact portion is greater than a distance L2 from the rigid portion to an inner surface of the inserting member insertion portion of the seal member.

6. The fixing device according to claim 1 or 4, wherein the fixing device has a plurality of rigid portions spaced apart from one another in the circumferential direction of the insertion member.

7. The fixing device according to claim 1 or 4, wherein the seal member has an accommodating hole that accommodates the rigid portion, and the rigid portion is accommodated in the accommodating hole so as to be movable relative to the seal member in the axial direction.

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