Fixing device

Abstract

A fixing device according to the present invention is a fixing device (1) that comprises a porous sheet element (2), a device body (3) which is provided with an insertion part (31), and an annular holding member (4), wherein the device body (3) is provided with a flange part (32) which extends outward along the outer circumference of a first end part (31a) so as to have a prescribed width, the holding member (4) is attachable to the outer side of the first end part (31a) of the insertion part (31), the flange part (32) has a first face (32a) which is on the outside of a living body in a state where the fixing device (1) is attached to the living body, and the sheet element (2) is inserted at the first end part (31a) of the insertion part (31) and is held by the first face (32a) of the flange part (32) and the holding member (4). With such a structure, it is possible to provide a fixing device which is capable of suppressing the occurrence of a level difference between a living body and a biocompatible sheet element implanted in the living body.

Description

Fixation device

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

[0002] As shown in Patent Document 1, when a medical tube is inserted into the body from outside, a skin fixation member is disclosed that is configured to sandwich a biocompatible nonwoven fabric such as PTFE felt between an inner body protruding body that protrudes into the body and a fixing nut.

[0003] Japanese Patent Application Laid-Open No. 2019-166310

[0004] In the skin fixing member described in Patent Document 1, the nonwoven fabric is fixed by a male screw portion provided on the intracorporeal protrusion and a fixing nut, so a step is created between the inner surface of the nonwoven fabric and the inner surface of the skin fixing member (the inner portion of the intracorporeal protrusion and the inner portion of the fixing nut). When such a step is created, cells have difficulty attaching to the step, preventing the cells from penetrating the nonwoven fabric.

[0005] Therefore, an object of the present invention is to provide a fixing device that can prevent the occurrence of a step between the living body and a biocompatible sheet member that is to be implanted in the living body.

[0006] The fixing device of the present invention is a fixing device comprising a porous sheet body made of a non-absorbable material having biocompatibility, a device main body having an insertion portion through which an insertion member can be inserted to be led from inside the living body to outside the living body, and an annular clamping member, wherein the device main body has a flange portion extending outward by a predetermined width along the outer periphery of a first end of the insertion portion which becomes the end inside the body when the fixing device is attached to the living body, the clamping member can be attached to the outside of the first end of the insertion portion, and the flange portion has a first surface which becomes the outside of the body when the fixing device is attached to the living body, and the sheet body is inserted into the first end of the insertion portion and is clamped by the first surface of the flange portion and the clamping member.

[0007] According to the fixing device of the present invention, it is possible to prevent the occurrence of a step between the living body and a biocompatible sheet member that is to be implanted in the living body.

[0008] 7 is a schematic diagram showing a state in which a fixing device according to one embodiment of the present invention is attached to wall-like tissue. FIG. 8 is an exploded perspective view of a fixing device according to one embodiment of the present invention. FIG. 9 is a side view of the device main body shown in FIG. 2. FIG. 10 is a top view of the device main body shown in FIG. 2. FIG. 11 is a top view of the clamping member shown in FIG. 2. FIG. 12 is a diagram showing a modified example of the clamping member. FIG. 13 is a diagram showing a state in which a sheet body is attached to the device main body. FIG. 14 is a diagram showing a state in which the clamping member is being inserted into the insertion portion from the state shown in FIG. 7, and before the clamping member has climbed over the engagement step portion. FIG. 15 is a cross-sectional view of the fixing device in a state in which the sheet body is clamped by the clamping member and the flange portion. FIG. 16 is an enlarged view of the portion in which the sheet body is clamped by the clamping member and the flange portion. FIG. 17 is a diagram showing a state in which the sheet body, clamped by the clamping member and the flange portion, is sewn to a filament.

[0009] 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.

[0010] In this specification, expressions such as "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, expressions such as "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, expressions such as "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).

[0011] As shown in Fig. 1 , the fixing device 1 of this embodiment is used to fix an inserting member IS, which is to be led from inside the living body to the wall-like tissue T of the living body. As shown in Fig. 1 , the fixing device 1 is fixed to the wall-like tissue T of the living body by being embedded at a predetermined position and a predetermined depth in the wall-like tissue T with the inserting member IS inserted therein. The use of the fixing device 1 is not particularly limited as long as it is used to fix an inserting member IS, which is to be led from inside the living body to the wall-like tissue T of the living body. For example, the fixing device 1 can be used in a skin button (cuff member) or the like through which the inserting member IS is inserted.

[0012] 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 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.

[0013] The use of the fixing device 1 is not particularly limited as long as it fixes the inserting member IS, which is led from inside the living body to the wall-like tissue T of the living body. 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 (for example, an artificial organ such as a ventricular assist device (VAD) or an artificial lung) through the wall-like tissue T of the abdomen and leading the driveline from inside the body to the outside. The driveline led outside the body is fixed at a predetermined position in the abdomen via the fixing device 1, as shown in FIG. 1 .

[0014] 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.

[0015] 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 external pump, and a power cable for connecting the artificial organ inside the body to an external power source. The insertion member IS may have only a power cable, or may have only a cooling water circulation passage. The insertion member IS may also have components with 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.

[0016] When inserting the inserting member IS through the wall-like tissue T, for example, as shown in Fig. 1 , the inserting member IS is inserted into the fixing device 1, and the fixing device 1 is fixed to the wall-like tissue T. As shown in Figs. 1 and 2 , the fixing device 1 of this embodiment includes a porous sheet body 2 made of a biocompatible non-absorbable material, a device main body 3 having an insertion portion 31 through which the inserting member IS can be inserted to be led from inside the living body to outside the living body, and an annular clamping member 4. As will be described in detail later, in this embodiment, as shown in Fig. 1 , the sheet body 2 is clamped between a flange portion 32 (described later) provided on the device main body 3 and the clamping member 4, and fixed to the wall-like tissue T. As a result, the inserting member IS is inserted into the wall-like tissue T via the fixing device 1 and fixed at a predetermined position.

[0017] The sheet body 2 is a portion that is embedded in the wall-like tissue T when the fixing device 1 is fixed (anchored) to the wall-like tissue T with the inserting member IS inserted through the wall-like tissue T (see FIG. 1 ). As will be described in detail below, as shown in FIG. 1 , the sheet body 2 is inserted into the first end 31 a of the inserting portion 31 and clamped between the first surface 32 a of the flange portion 32 and the clamping member 4. For example, while being clamped between the first surface 32 a of the flange portion 32 and the clamping member 4, the sheet body 2 is embedded in the wall-like tissue T so as to slip under a portion of the wall-like tissue T (e.g., skin) that has been incised to insert the inserting member IS. In this way, the sheet body 2 is fixed to a predetermined portion of the wall-like tissue T as shown in FIG. 1 .

[0018] The sheet body 2 is made of a biocompatible, non-absorbable material. The biocompatible, non-absorbable material making up the sheet body 2 can be the same material as that used as a medical sheet inside the body or at a wound site. The sheet body 2 is preferably made of a flexible material. The material making up the sheet body 2 can be, for example, at least one selected from the group consisting of polyurethane resin, polyamide resin, polylactic acid resin, polyolefin resin, polyester resin, fluororesin, urea resin, phenolic resin, epoxy resin, polyimide resin, acrylic resin, methacrylic resin, and derivatives thereof, and preferably expanded polytetrafluoroethylene (ePTFE).

[0019] Furthermore, the sheet body 2 is preferably made of a porous sheet in order to promote the growth and settlement of cells of the wall-like tissue T in the sheet body 2. The pore size (average pore size) of the porous sheet body 2 is not particularly limited as long as it is a size that allows cells to easily grow and settle when the sheet body 2 is embedded in the wall-like tissue T. The average pore size of the sheet body 2 can be, for example, 10 to 100 μm.

[0020] The shape of the sheet body 2 is not particularly limited as long as it allows the insertion of the insertion member IS through the insertion portion 31 and is suitable for embedding in the wall-like tissue T. In this embodiment, the sheet body 2 has an opening 21 in its central portion. In this embodiment, the sheet body 2 is formed in a substantially elliptical (approximately oblong) shape, but may be formed in a shape other than the illustrated shape, such as a circular or polygonal shape. The size of the sheet body 2 is not particularly limited and may be changed as appropriate depending on the size of the insertion portion 31 of the device main body 3 that is inserted into the sheet body 2, as well as the purpose and fixation location of the fixation device 1. In this embodiment, the sheet body 2 is sized to protrude outward from the flange portion 32 of the device main body 3. The sheet body 2 may be sized, for example, similar to the size of the flange portion of a known skin button (cuff member) that is embedded in the wall-like tissue T. When the sheet body 2 has the shape shown in the figure, the longitudinal dimension of the sheet body 2 can be, for example, 10 to 80 mm, and the lateral dimension can be, for example, 5 to 60 mm (e.g., a length of about 30 to 50% of the longitudinal dimension). The thickness of the sheet body 2 is not particularly limited, but can be, for example, 0.5 to 5 mm. When the sheet body has a circular shape, the diameter of the sheet body can be, for example, 5 to 80 mm.

[0021] The opening 21 provided in the sheet body 2 penetrates the sheet body 2 in the thickness direction at the center of the sheet body 2. The size of the opening 21 is appropriately set to a size that allows the sheet body 2 to be inserted into the first end 31 a of the insertion portion 31 of the fixing device 1.

[0022] The device main body 3 is a base portion of the fixing device 1, into which the inserting member IS is inserted and to which the sheet body 2 and the clamping member 4 are attached on the outside. In this embodiment, as shown in Figures 3 and 4, the device main body 3 has an inserting portion 31 through which the inserting member IS can be inserted, and a flange portion 32 that extends outward by a predetermined width along the outer periphery of a first end portion 31a of the inserting portion 31, which is the end portion inside the body when the fixing device 1 is attached to the living body.

[0023] The insertion portion 31 is a portion of the device main body 3 through which the insertion member IS is inserted. The insertion portion 31 communicates between the inside of the living body and the outside of the living body. In this embodiment, the insertion portion 31 is a portion through which the insertion member IS, such as a driveline, is inserted and is configured in a substantially cylindrical shape. As shown in FIGS. 1 to 3 , the insertion portion 31 has a first end 31a that is the end inside the living body and a second end 31b that is the end outside the living body. As shown in FIG. 9 , the insertion portion 31 has a first opening 311a provided on the first end 31a side (inside the living body) and a second opening 311b provided on the second end 31b side (outside the living body), and an insertion passage 311 that penetrates the insertion portion 31 is provided between the first opening 311a and the second opening 311b. The first end 31a is a predetermined region of the insertion portion 31 extending from the first opening 311a to the second opening 311b, and the second end 31b is a predetermined region of the insertion portion 31 extending from the second opening 311b to the first opening 311a. In this embodiment, the outer portion of the first end 31a (an attachment portion 312 described later) is configured as a body portion that protrudes and extends in a separation direction D away from the flange portion 32 (an imaginary plane S formed so that the outer periphery of the flange portion 32 is included in one plane (hereinafter simply referred to as the imaginary plane S of the flange portion 32)), as shown in FIG. 3 . The separation direction D may be any direction as long as it intersects with the flange portion 32 (the imaginary plane S). In this embodiment, the attachment portion 312, which is the outer portion of the first end 31a, protrudes in a direction perpendicular to the imaginary plane S of the flange portion 32. In this specification, the separation direction D can also be referred to as the thickness direction of the sheet body 2 or the thickness direction of the clamping member 4. In this specification, when referring to the insertion portion 31 (or the first end portion 31 a), the "inside" and "outside" refer to the inner peripheral portion of the insertion portion 31 that is close to the axis of the insertion passage 311, and the outer peripheral portion of the insertion portion 31 (or the first end portion 31 a) that is opposite the inside, as the "outside." Furthermore, when referring to each part of the fixing device 1 as "protruding outward" or "overhanging outward," it means that each part protrudes or overhangs in the direction from the inside (inner peripheral) of the insertion portion 31 to the outside (outer peripheral) thereof.

[0024] The shape and structure of the insertion portion 31 are not particularly limited as long as the insertion portion 31 can support the insertion member IS against the living body with the insertion portion 31 inserted therein. In this embodiment, the insertion portion 31 is configured to protrude outside the living body, as shown in Fig. 1. Specifically, the insertion portion 31 is configured such that the axis of the insertion passage 311 is inclined with respect to the imaginary plane S of the flange portion 32, as shown in Fig. 3, but the inclination angle of the axis of the insertion passage 311 is not particularly limited. Furthermore, the insertion passage 311 may be provided so as to be perpendicular to the imaginary plane S of the flange portion 32.

[0025] Although not shown, the insertion portion 31 may include a chuck member disposed between the inner wall of the insertion portion 31, which defines the insertion passage 311, and the outer surface of the insertion member IS, which fastens and grips the outer peripheral surface of the insertion member IS, and a seal member for maintaining the insertion member IS in a liquid-tight state within the insertion passage 311. The chuck member and seal member provided between the inner wall of the insertion portion 31 and the outer surface of the insertion member IS may have a known configuration, and therefore detailed description thereof will be omitted. The material constituting the insertion portion 31 is biocompatible and has a predetermined rigidity. For example, the material constituting the insertion portion 31 may be a biocompatible, highly corrosion-resistant metal material such as titanium or a titanium alloy.

[0026] In this embodiment, as shown in Fig. 3 , the insertion portion 31 has an attachment portion 312 configured to be able to attach the clamping member 4 on the outer side of the first end portion 31a of the insertion portion 31. As shown in Fig. 3 , the attachment portion 312 is provided spaced apart from the flange portion 32 in the separation direction D (thickness direction of the sheet body 2), and includes an engagement step 312a that protrudes outward (in a direction intersecting the separation direction D) at the first end portion 31a, and a holding groove 312b that is provided between the engagement step 312a and the flange portion 32 in the separation direction D. In this embodiment, the portion of the insertion portion 31 on the opposite side of the flange portion 32 in the separation direction D from the engagement step 312a (upper side in Fig. 3 ) is configured to be slightly smaller than the engagement step 312a in the protruding direction of the engagement step 312a. In this case, when attaching the sheet body 2 or the clamping member 4 to the holding groove 312b from the second end 31b side, the sheet body 2 or the clamping member 4 can be easily moved to the position of the engagement step 312a (the position shown in Figure 8).

[0027] The engaging step 312a is configured to at least partially engage with an inner peripheral edge 4a of the clamping member 4 (described later) in the separation direction D, and functions as a retaining portion for the clamping member 4. In this embodiment, as shown in FIG. 3 , the engaging step 312a protrudes from the portion adjacent to the engaging step 312a in the separation direction D on the outside of the first end 31a of the insertion portion 31. In this embodiment, the engaging step 312a is configured as a protrusion that protrudes continuously in the circumferential direction of the insertion portion 31. However, the engaging step may not be continuous in the circumferential direction of the insertion portion 31, but may protrude partially.

[0028] Although details will be described later, in this embodiment, when the sheet body 2 and the clamping member 4 are attached to the outside of the first end 31a of the insertion portion 31 (see FIGS. 1 and 9 ), the sheet body 2 is pressed in the thickness direction of the sheet body 2 by the clamping member 4, and the clamping member 4 engages with the engagement step 312a. In this case, when the clamping member 4 presses the sheet body 2, a reaction force is applied from the sheet body 2 to the clamping member 4, and the surface of the clamping member 4 opposite the sheet body 2 is pressed against the engagement step 312a. Therefore, the attachment of the sheet body 2 and the clamping member 4 is completed simply by placing the sheet body 2 and the clamping member 4 outside the first end 31a of the insertion portion 31 (in the holding groove 312b). This allows the sheet body 2 and the clamping member 4 to be temporarily fixed, simplifying the assembly of the fixing device 1. Furthermore, the sheet body 2 itself does not engage with the engaging step 312a, but the clamping member 4 having a predetermined width that engages with the engaging step 312a prevents the sheet body 2 from being released from the holding groove 312b. Therefore, even if the engaging step 312a does not protrude outwardly by a large amount, the sheet body 2 can be stably held in the holding groove 312b by the clamping member 4 having a predetermined width. Therefore, there is no need to complicate the structure of the device main body 3, for example, by increasing the protrusion amount of the engaging step 312a.

[0029] 1 and 9 , the holding groove 312b is a groove into which the inner peripheral edge 4a of the clamping member 4 is disposed when the clamping member 4 engages with the engagement step 312a. The length of the holding groove 312b in the separation direction D is not particularly limited as long as it is wide enough to clamp the sheet body 2 between the clamping member 4 and the flange portion 32. In this embodiment, the length of the holding groove 312b in the separation direction D is configured to be shorter than the sum of the thickness of the clamping member 4 and the thickness of the sheet body 2.

[0030] The flange portion 32 clamps the sheet body 2 together with the clamping member 4. In this embodiment, the flange portion 32 is formed integrally with the insertion portion 31. The flange portion 32 may be formed porous to promote cell growth and settlement. Furthermore, as shown in FIG. 2 , the flange portion 32 may have a plurality of holes H. The plurality of holes H may be holes into which the filaments 5 described below are attached, or may be holes into which cells invade by appropriately setting the size of the holes H without using the filaments 5, or holes into which the filaments 5 are attached and into which the cells invade.

[0031] As shown in Figures 1 to 3, the flange portion 32 extends outward by a predetermined width along the outer periphery of the first end portion 31a of the insertion portion 31. The shape of the flange portion 32 is not particularly limited as long as it can hold the sheet body 2 together with the holding member 4. In this embodiment, the flange portion 32 is formed in a substantially elliptical shape (substantially oval shape) as shown in Figures 2 and 4. However, the flange portion 32 can be changed as appropriate depending on the outer periphery shape of the insertion portion 31 and the shape of the sheet body 2.

[0032] 1 and 9, the flange portion 32 has a first surface 32a that faces outside the body when the fixing device 1 is attached to the living body. The flange portion 32 also has a second surface 32b on the opposite side of the first surface 32a.

[0033] The first surface 32a is the surface of the flange portion 32 that faces outside the body (the side opposite to the inside of the body) when attached to a living body (wall-like tissue T) as shown in Fig. 1. The first surface 32a faces and contacts the sheet body 2 when the sheet body 2 is inserted into the insertion portion 31. The first surface 32a, together with the clamping member 4, clamps the sheet body 2 as shown in Figs. 1 and 9.

[0034] In this embodiment, the first surface 32a supports the inner peripheral portion of the sheet body 2, which is a portion of a predetermined width from the inner peripheral edge 2a, in the direction from the inner peripheral edge 2a toward the outer peripheral edge 2b of the sheet body 2. As a result, the shape of the inner peripheral portion of the sheet body 2 that overlaps with the first surface 32a is maintained by the first surface 32a, and the shape of the portion of the sheet body 2 that protrudes outward from the first surface 32a is also stabilized to a certain extent. Therefore, during treatment, such as when attaching the fixation device 1 to wall-like tissue T, the shape of the thin sheet body 2 is stabilized, making it easier for the doctor to handle the fixation device 1.

[0035] 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 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 the flange portion 32 being supported by a predetermined width or more. Furthermore, the amount of protrusion of the flange portion 32 (the amount of overlap with the sheet body 2) can be 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, a predetermined width of the flexible portion of the sheet body 2 is ensured, making it easier to position the sheet body 2 in accordance with the curvature of the wall-like tissue T.

[0036] Furthermore, in this embodiment, as shown in Figures 7 to 10, the first surface 32a of the flange portion 32 has an inclined surface that slopes from the outer periphery of the flange portion 32 toward the outer periphery of the insertion portion 31 toward the outside of the body when the fixation device 1 is attached to the living body. In this case, when the sheet body 2 is placed on the first surface 32a formed by the inclined surface, the portion of the sheet body 2 that protrudes outward from the flange portion 32 is inclined according to the inclination angle of the inclined surface, as shown in Figures 7 to 9. Therefore, the portion of the sheet body 2 that protrudes from the flange portion 32 is not flat (parallel to the imaginary plane S) but is slightly curved and skirt-like. This makes it easy to position the portion of the sheet body 2 that protrudes from the flange portion 32 along the surface of the curved wall-like tissue T, thereby preventing a gap from forming between the wall-like tissue T and the sheet body 2.

[0037] In this embodiment, as shown in FIGS. 9 and 10 , the holding groove 312b has a curved portion that is convex toward the center of the insertion portion 31 (the axis of the insertion passage 311), and the curved portion is connected to the inclined surface of the flange portion 32. The inclined surface of the flange portion 32 and the curved surface of the holding groove 312b form a continuous, smooth surface, which prevents the sheet body 2, which is inclined along the inclined surface of the flange portion 32, from suddenly changing angle at the boundary between the flange portion 32 and the holding groove 312b. Therefore, the sheet body 2 easily follows the inclined surface of the flange portion 32 and the curved surface of the holding groove 312b. This prevents gaps from being generated between the sheet body 2 and the inclined surface of the flange portion 32 and the curved surface of the holding groove 312b. Furthermore, as shown by the dotted line in Figure 10, for example, when the sheet body 2 is compressed in the thickness direction of the sheet body 2 by the clamping member 4 and the inner peripheral edge 2a of the sheet body 2 is displaced (expands) toward the bottom of the holding groove 312b, the inner peripheral edge 2a portion of the sheet body 2 can be smoothly released.

[0038] The second surface 32b, together with the sheet body 2, faces the wall-like tissue T when the fixing device 1 is placed on the wall-like tissue T. The second surface 32b can be configured as a smooth plane or a curved surface. In this embodiment, as shown in FIG. 9 , the second surface 32b of the flange portion 32 is configured as a curved surface that becomes convex toward the outside of the body as it extends from the outer periphery of the flange portion 32 toward the inside when the fixing device 1 is attached to the living body. In this case, when the fixing device 1 is placed on the wall-like tissue T, the second surface 32b is positioned along the curved wall-like tissue T, preventing the formation of a gap between the wall-like tissue T and the second surface 32b. Unlike the flexible sheet body 2, the flange portion 32 is often made of a metal that is highly rigid and does not deform to conform to the surface of the wall-like tissue T. However, the curved second surface 32b facilitates close contact with the curved skin surface.

[0039] 9, in this embodiment, 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 extending from the flange portion 32 of the sheet body 2 and the curved surface of the second surface 32b of the flange portion 32 form a continuous curved surface. This allows the sheet body 2 to be placed in closer contact with the surface of the curved, wall-like tissue T.

[0040] The clamping member 4 can be attached to the outside of the first end 31a of the insertion portion 31, and clamps the sheet body 2 together with the flange portion 32. More specifically, as shown in FIG. 1 , the clamping member 4, together with the flange portion 32, clamps the inner peripheral portion of the sheet body 2 in the thickness direction of the sheet body 2 to hold the sheet body 2. The material constituting the clamping member 4 is biocompatible and has a predetermined rigidity. For example, the material constituting the clamping member 4 may be a metal material that is biocompatible and highly corrosion-resistant, such as titanium or a titanium alloy.

[0041] The clamping member 4 is configured as a separate member from the device main body 3 and is attached to the insertion portion 31 of the device main body 3. In this embodiment, the clamping member 4 is formed in an annular shape and has an opening 41 in the center, as shown in Figures 2 and 5. The clamping member 4 is attached to the device main body 3 by being inserted into the insertion portion 31 through the opening 41, as shown in Figures 8 and 9, and clamps the sheet body 2 that has previously been inserted into the insertion portion 31 together with the flange portion 32.

[0042] In this embodiment, the clamping member 4 is flexible and configured to be elastically deformable so as to overcome the engagement step 312a in the separation direction D. After the clamping member 4 overcomes the engagement step 312a, it elastically returns to its original shape, and the inner peripheral edge 4a of the clamping member 4 engages with the engagement step 312a (see FIGS. 9 and 10 ). In this embodiment, the clamping member 4 is formed in a flat plate shape and is easily elastically deformable. When the clamping member 4 is attached to the insertion portion 31, as shown in FIGS. 9 and 10 , the inner peripheral edge 4a of the clamping member 4 is positioned in the holding groove 312b and is configured to engage with the engagement step 312a in the separation direction D.

[0043] The size of the clamping member 4 can be changed as appropriate depending on the application for which the fixing device 1 is used and the sizes of the sheet body 2 and the insertion portion 31. When the clamping member 4 is inserted into the insertion portion 31, it is preferable that the amount of protrusion of the first end portion 31a from the outside (retaining groove 312b) is approximately the same as that of the flange portion 32 (for example, 80 to 120% of the amount of protrusion of the flange portion 32). In this case, the sheet body 2 is clamped by the flange portion 32 and the clamping member 4 with a predetermined uniform contact width, and the sheet body 2 is stably held.

[0044] The shape of the clamping member 4 can be changed as appropriate depending on the shapes of the sheet body 2 and the insertion portion 31. In this embodiment, the overall shape of the clamping member 4 is an ellipse (approximately oval) having an opening 41 on the inside, as shown in FIGS. 2 and 5 . In this embodiment, the outer peripheral edge 4 b and the inner peripheral edge 4 a of the clamping member 4 are provided with a plurality of recesses 42 that are recessed in a direction connecting the outer peripheral edge 4 b and the inner peripheral edge 4 a of the clamping member 4 along the circumferential direction of the clamping member 4. The provision of the recesses 42 in the clamping member 4 makes the clamping member 4 more flexible and facilitates attachment to the insertion portion 31. More specifically, as shown in FIG. 5 , the recesses 42 are formed by cutting out a substantially semicircular shape, and the distance between a pair of recesses 42, 42 adjacent to each other in the circumferential direction on the inner peripheral edge 4 a is smaller than the circumferential width of the recesses 42. In this case, the portion of the inner peripheral edge 4a of the clamping member 4 that engages with the engagement step 312a is less than half of the inner peripheral edge 4a of the clamping member 4. Therefore, resistance when overcoming the engagement step 312a during attachment of the clamping member 4 is reduced, making attachment of the clamping member 4 even easier. Furthermore, by providing the recess 42 on the outer peripheral edge 4b ​​of the clamping member 4, cells can enter the recess 42 on the outer peripheral edge 4b, thereby suppressing the circumferential rotation of the fixing device 1 around the clamping member 4. Therefore, the fixing device 1 can be stably held on the wall-like tissue T. Furthermore, in this embodiment, the recess 42 formed on the outer peripheral edge 4b ​​of the clamping member 4 and the recess 42 formed on the inner peripheral edge 4a are positioned at positions offset from each other in the circumferential direction. Specifically, as shown in FIG. 5 , the recess 42 formed on the outer peripheral edge 4b ​​is positioned between a pair of recesses 42, 42 formed on the inner peripheral edge 4a. This makes it easier for the clamping member 4 to bend, and therefore, for example, when the fixation device 1 is attached to wall-like tissue T, it becomes easier for the clamping member 4 to follow the movement of the insertion member IS such as a driveline, thereby preventing the clamping member 4 from coming off the insertion portion 31. Furthermore, because the portion between adjacent recesses 42 of the inner peripheral edge 4a has a convex shape, the depth of engagement with the engaging step portion 312a can be made deeper compared to a configuration without recesses 42, making it more difficult for the clamping member 4 to come off the insertion portion 31.

[0045] The recess may be provided only on the inner peripheral edge 4 a of the clamping member 4, or may be provided only on the outer peripheral edge 4 b. The recess may also have a polygonal cutout shape such as a triangular or rectangular shape.

[0046] In addition, the recess 42 makes it easier for the clamping member 4 to elastically deform, so that when the clamping member 4 is sewn with the thread-like body 5, as described below, the clamping member 4 deforms and becomes tightly attached so that there is no gap between the clamping member 4 and the sheet body 2.

[0047] The clamping member 4 may not have recesses on the inner peripheral edge 4a and the outer peripheral edge 4b, as in the modified example shown in Fig. 6. Alternatively, the clamping member 4 may have through-holes 43 that penetrate the clamping member 4 in the thickness direction of the clamping member 4, as shown in Fig. 5 and Fig. 6. When the clamping member 4 is provided with through-holes 43, as shown in Fig. 1, when the clamping member 4 is placed on wall-like tissue T, cells can enter the inside of the through-holes 43, allowing the fixing device 1 to be stably fixed.

[0048] In this embodiment, as shown in FIG. 11 , when the clamping member 4 is attached to the holding groove 312b, the hole H of the device body 3 is configured to overlap 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 penetrate each other 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 penetrate each other in the separation direction D. This makes it easier for cells that have invaded through the hole H of the device body 3 to 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 body 2. Furthermore, cells that have invaded through the through-hole 43 of the clamping member 4 or the recess 42 of the inner peripheral edge 4a of the clamping member 4 also penetrate the hole H of the device body 3 via the sheet body 2. This makes it easier to fix the fixing device 1 stably. Furthermore, the filament 5 inserted through the hole H in the device body 3 can be easily inserted into the recessed portion 42 on the inner peripheral edge 4 a of the clamping member 4, facilitating sewing of the filament 5. The amount by which the hole H in the device body 3 overlaps with the through-hole 43 of the clamping member 4 and the recessed portion 42 on the inner peripheral edge 4 a of the clamping member 4 in the separation direction D can be appropriately set within a range that allows easy penetration of cells and difficult penetration of bacteria. In this embodiment, as shown in FIG. 11 , the hole H in the device body 3 is provided at positions in the circumferential direction of the clamping member 4 that correspond to each of the multiple recessed portions 42 on the inner peripheral edge 4 a of the clamping member 4. As shown in FIG. 11 , the through-holes 43 in the clamping member 4 are provided at positions in the circumferential direction of the clamping member 4 that correspond to each of the multiple holes H in the device body 3.

[0049] In the fixation device 1 of this embodiment, as shown in FIGS. 1 and 9 , the sheet body 2 is inserted into the first end 31 a of the insertion portion 31 and is clamped between the first surface 32 a of the flange portion 32 and the clamping member 4. That is, when attaching the sheet body 2 to the insertion portion 31 of the device main body 3, the sheet body 2 is held by being clamped between the first surface 32 a, which is the surface of the flange portion 32 facing the body outside, and the clamping member 4. Therefore, when holding the sheet body 2 in the device main body 3, a fastening member such as a nut does not protrude from the portion of the device main body 3 facing the body inside (e.g., the second surface 32 b side of the flange portion 32), as in Patent Document 1. This prevents the formation of a step on the surface of the fixation device 1 facing the body inside. Therefore, it is possible to prevent the formation of a step between the sheet body 2 and the flange portion 32 and the wall-like tissue T, which would make it difficult for cells to adhere.

[0050] Next, a description will be given of a method for assembling the fixing device 1. Note that the following description is merely an example, and the configuration of the fixing device 1 is not limited to the following description.

[0051] First, as shown in FIGS. 2 and 3 , a device main body 3 including an insertion portion 31 and a flange portion 32 is prepared. Next, as shown in FIG. 7 , a sheet body 2 having an opening 21 is inserted into the insertion portion 31 from the second end 31b side of the insertion portion 31, and the sheet body 2 is positioned so that the inner peripheral portion of the sheet body 2 overlaps the first surface 32a of the flange portion 32. Next, as shown in FIG. 8 , a clamping member 4 is inserted into the insertion portion 31 from the second end 31b side of the insertion portion 31. The clamping member 4 is pushed toward the flange portion 32 from the state where it is caught on the engagement step 312a shown in FIG. 8 . When the clamping member 4 is pushed toward the flange portion 32, the clamping member 4 elastically deforms and overcomes the engagement step 312a. As a result, the sheet body 2 is clamped by the clamping member 4 and the first surface 32a of the flange portion 32, as shown in FIGS. 1 and 9 . This prevents the formation of portions that protrude toward the inside of the body in the portions of the sheet body 2 and the second surface 32b of the flange portion 32 that are inside the body, and prevents the formation of steps on the surface of the fixation device 1 that faces the inside of the body. Therefore, when the fixation device 1 is placed against wall-like tissue T as shown in Fig. 1, the formation of steps that would make it difficult for cells to adhere is prevented between the sheet body 2 and the flange portion 32 and the wall-like tissue T. This allows the sheet body 2 to adhere closely to the wall-like tissue T, making it easier for cells to invade the sheet body 2 and promoting cell growth and settlement.

[0052] In this embodiment, when the clamping member 4 moves over the engagement step 312a, the pressing force of the clamping member 4 toward the flange 32 presses the sheet body 2 toward the flange 32 and compresses it (the state shown by the two-dot chain line in FIG. 10 ). The clamping member 4 that has moved over the engagement step 312a receives a reaction force (an upward reaction force in FIG. 10 ) from the compressed sheet body 2 toward the engagement step 312a. As a result, the clamping member 4 engages with the engagement step 312a in a state where it is pressed upward in FIG. 10 . Therefore, there is no need to use fastening members such as screws or nuts to secure the sheet body 2, and the sheet body 2 can be stably held with a simple configuration.

[0053] When the sheet 2 is compressed in the thickness direction by the clamping member 4, the inner peripheral edge 2a of the sheet 2 is deformed so as to escape toward the groove bottom of the holding groove 312b (see the two-dot chain line in FIG. 10 ). In this embodiment, as described above, the holding groove 312b has a curved surface that forms a smooth surface continuous with the inclined surface of the first surface 32a of the flange portion 32. Therefore, as shown in FIG. 10 , the inner peripheral edge 2a of the sheet 2 can smoothly escape toward the groove bottom of the holding groove 312b (toward the upper right in FIG. 10 ).

[0054] As a modification of the above-described embodiment, as shown in FIG. 11 , the sheet body 2 may be sandwiched between the first surface 32 a of the flange portion 32 and the clamping member 4 and then sewn and fixed with filaments 5. In this case, the sheet body 2 can be more stably fixed, and the sewn filaments 5 form a minute uneven structure without large steps at the contact points of the fixation device 1 with the wall-like tissue T. This uneven structure formed by the filaments 5 acts as a resistance to relative movement between the fixation device 1 and the wall-like tissue T, thereby preventing the fixation device 1 from shifting relative to the wall-like tissue T. Furthermore, minute spaces are formed between the filaments 5 and the clamping member 4, between the filaments 5 and the sheet body 2, and between the filaments 5 and the flange portion 32, and cells can enter these minute spaces, enabling early fixation between the fixation device 1 and the wall-like tissue T. Note that the device main body 3 is not shown in FIG. 11 for ease of illustration.

[0055] Like the sheet 2, the filaments 5 are made of a biocompatible, non-absorbable material. The biocompatible, non-absorbable material constituting the filaments 5 can be the same material as that used for medical sutures. The material constituting the filaments 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, fluororesin, urea resin, phenolic resin, epoxy resin, polyimide resin, acrylic resin, methacrylic resin, and derivatives thereof, and preferably expanded polytetrafluoroethylene (ePTFE). Furthermore, the filaments 5 are preferably porous to promote cell growth and settlement in the wall-like tissue T.

[0056] The thickness of the filamentous body 5 is not particularly limited as long as it can form an uneven structure that provides resistance to relative movement with respect to the target site in the extension direction of the sheet body 2. For example, a thread having a diameter of 0.1 to 0.5 mm, preferably 0.1 to 0.3 mm, and more preferably 0.2 mm can be used.

[0057] The filaments 5 are sewn to the sheet body 2 using a predetermined stitching pattern. The stitching pattern of the filaments 5 is not particularly limited as long as it can form an uneven structure that provides resistance to relative movement with respect to the target area in the extension direction of the sheet body 2. In this embodiment, as shown in Fig. 11 , the filaments 5 are sewn alternately from the recesses 42 on the inner periphery 4a of the clamping member 4 to the recesses 42 on the outer periphery 4b of the clamping member 4, and from the recesses 42 on the outer periphery 4b of the clamping member 4 to the recesses 42 on the inner periphery 4a of the clamping member 4. Furthermore, the filaments 5 are sewn at the positions of the recesses 42 so as to pass through the holes H in the sheet body 2 and the flange portion 32 in the thickness direction of the sheet body 2 from the outside to the inside of the body and from the inside to the outside of the body. Specifically, the filament 5 that passes through the hole H in the flange portion 32, the sheet body 2, and the recess 42 in the inner peripheral edge 4a of the clamping member 4 is sewn so as to pass through the recess 42 in the outer peripheral edge 4b ​​of the clamping member 4 and the sheet body 2, and the filament 5 is sewn to the hole H adjacent to the hole H in the flange portion 32. The filament 5 is then sewn to the clamping member 4 in the same manner. The filament 5 may also be sewn to a portion of the sheet body 2 that protrudes outward from the flange portion 32 and is not clamped by the flange portion 32 and the clamping member 4. When the filament 5 is sewn to the sheet body 2 while it is clamped between the clamping member 4 and the flange portion 32, the engaging step 312a does not need to be provided. The sewing procedure is not limited to the order or direction described above.

[0058] 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.

[0059] (1) A fixing device comprising: a porous sheet body made of a non-absorbable material having biocompatibility; a device main body having an insertion portion through which an insertion member can be inserted to be led from inside the living body to outside the living body; and an annular clamping member, wherein the device main body has a flange portion extending outward by a predetermined width along the outer periphery of a first end of the insertion portion which is the end inside the body when the fixing device is attached to the living body; the clamping member is attachable to the outside of the first end of the insertion portion; and the flange portion has a first surface which is the outside of the body when the fixing device is attached to the living body; and the sheet body is inserted into the first end of the insertion portion and is clamped by the first surface of the flange portion and the clamping member.

[0060] (2) The fixation device according to (1), wherein the first surface of the flange portion has an inclined surface that is inclined from the outer periphery of the flange portion toward the outer periphery of the insertion portion so as to face toward the outside of the body when the fixation device is attached to a living body.

[0061] (3) The fixation device according to (1) or (2), wherein a second surface of the flange portion opposite to the first surface is configured as a curved surface that becomes convex outward from the body when the fixation device is attached to a living body as it extends inward from the outer periphery of the flange portion.

[0062] (4) A fixing device described in any one of (1) to (3), in which a plurality of recesses are provided on the outer peripheral edge and / or inner peripheral edge of the clamping member, which are recessed in a direction connecting the outer peripheral edge and inner peripheral edge of the clamping member along the circumferential direction of the clamping member.

[0063] (5) A fixing device described in any one of (1) to (4), wherein the sheet body is sandwiched between the first surface of the flange portion and the clamping member and fixed by sewing with the thread-like body.

[0064] DESCRIPTION OF SYMBOLS 1 Fixing device 2 Sheet body 2a Inner peripheral edge of sheet body 2b Outer peripheral edge of sheet body 21 Opening 3 Device body 31 Insertion portion 31a First end 31b Second end 311 Insertion passage 311a First opening 311b Second opening 312 Mounting portion 312a Engagement step portion 312b Retaining groove 32 Flange portion 32a First surface 32b Second surface 4 Clamping member 4a Inner peripheral edge of clamping member 4b Outer peripheral edge of clamping member 41 Opening 42 Recess 43 Through hole 5 Filament D Separation direction H Hole IS Insertion member S Imaginary surface of flange portion T Wall-like structure

Claims

1. A fixing device comprising: a porous sheet body made of a non-absorbable material having biocompatibility; a device main body having an insertion portion through which an insertion member can be inserted to be led from inside the living body to outside the living body; and an annular clamping member, wherein the device main body has a flange portion extending outward by a predetermined width along the outer periphery of a first end of the insertion portion which is the end inside the body when the fixing device is attached to the living body, the clamping member is attachable to the outside of the first end of the insertion portion, the flange portion has a first surface which is the outside of the body when the fixing device is attached to the living body, and the sheet body is inserted into the first end of the insertion portion and is clamped between the first surface of the flange portion and the clamping member.

2. The fixing device according to claim 1, wherein the first surface of the flange portion has an inclined surface that is inclined from the outer periphery of the flange portion toward the outer periphery of the insertion portion so as to be inclined toward the outside of the body when the fixing device is attached to a living body.

3. A fixing device according to claim 1, wherein a second surface of the flange portion opposite the first surface is configured as a curved surface that becomes convex outwardly from the body when the fixing device is attached to a living body, as it moves inward from the outer periphery of the flange portion.

4. A fixing device as described in claim 1, wherein the outer peripheral edge and / or inner peripheral edge of the clamping member is provided with a plurality of recesses that are concave in the direction connecting the outer peripheral edge and inner peripheral edge of the clamping member along the circumferential direction of the clamping member.

5. A fixing device according to any one of claims 1 to 4, wherein the sheet body is sandwiched between the first surface of the flange portion and the clamping member and fixed by sewing with the thread-like body.

Images