Anus opening device

Abstract

This anus opening device comprises: a cylindrical anal dilator having one end part and the other end part; and an insertion auxiliary tool having a body inserted into the anal dilator and contained inside the anal dilator, and a conical tip part protruding from the one end part of the anal dilator. An inclined surface that extends from the outer peripheral surface of the tip part of the insertion auxiliary tool is formed at the one end part of the anal dilator.

Description

Anal dilation device

[0001] This invention relates to an anal opening device.

[0002] Conventionally, devices for dilating the anus have been proposed for various purposes. For example, Patent Document 1 discloses an anal dilator from the viewpoint of facilitating surgical procedures for rectal cancer. The anal dilator consists of a conical part, a gripping part integrated with the conical part, and a pair of semi-cylindrical bodies. The pair of semi-cylindrical bodies is inserted into the anus together with the conical part, then the gripping part and the conical part are withdrawn from the pair of semi-cylindrical bodies, and after the anus is kept open to a predetermined diameter by the pair of semi-cylindrical bodies, the semi-cylindrical bodies are withdrawn from the anus.

[0003] Patent Document 2 discloses an anoscope as a device used for treating hemorrhoids. The anoscope consists of a cylindrical body that can be inserted into the anus, and one or more handles that extend radially from the rear end of the cylindrical body and rotate the cylindrical body inserted into the anus around its axis.

[0004] Patent Document 3 discloses a surgical system that can be inserted rectally. In this system, a sleeve device having a proximal end and a distal end is open at its proximal end. The sleeve device has a window region on one side of the sleeve device that extends along the length of the sleeve device to the region of its distal end. A shield portion is configured to slide along the sleeve device to at least partially close the window region. The sleeve device, including the shield portion, is insertable into an anal dilator ring.

[0005] Japanese Patent Publication No. 09-168542, Japanese Patent Publication No. 2003-235799, Japanese Patent Publication No. 2009-504209

[0006] For patients undergoing anal dilation, the forced insertion of a device into the narrow anus and subsequent dilation often causes some pain. Therefore, there is a need to develop a device that can be inserted into the anus as smoothly as possible and alleviate patient pain.

[0007] Therefore, an object of one embodiment of the present invention is to provide an anal opening device that can be smoothly inserted into the anus and can reduce the pain felt by the patient.

[0008] An anal dilation device according to one embodiment of the present invention includes a cylindrical anal dilator having one end and the other end, an insertion aid having a main body that is inserted into the anal dilator and fits inside the anal dilator, and a conical tip that protrudes from the one end of the anal dilator, wherein the one end of the anal dilator has an inclined surface that is continuous with the outer circumferential surface of the tip of the insertion aid.

[0009] To use this anal dilation device, the assembled device (anal dilator and insertion aid) is inserted into the anus starting from the tip of the insertion aid. After inserting the main body of the insertion aid until it reaches the inside of the anus, the anal dilator can be left in place by removing the insertion aid. One end of the anal dilator has a sloped surface that extends from the outer surface (slope) of the tip of the insertion aid, which reduces the resistance felt by the patient when the boundary between the insertion aid and the anal dilator comes into contact with the area around the anus. As a result, this anal dilation device can be inserted smoothly into the anus, reducing the pain felt by the patient.

[0010] Furthermore, "an inclined surface extending from the outer circumferential surface (inclined surface) of the tip" may be defined, for example, as an inclined surface formed in continuity with the outer circumferential surface (inclined surface) of the tip.

[0011] In an anal opening device according to one embodiment of the present invention, the insertion aid includes a stepped portion at the boundary between the tip and the main body, having an annular concave auxiliary mating surface formed along the outer circumference of the insertion aid, and the one end of the anal dilator has an annular visor portion that protrudes inward to form the opening of the anal dilator and has an inward dilator mating surface that fits the auxiliary mating surface, and the outer surface of the visor portion may be formed as the inclined surface when the dilator mating surface fits the auxiliary mating surface and the visor portion engages with the stepped portion.

[0012] In this configuration, the visor of the anal dilator engages with the stepped portion (adapter side mating surface) of the insertion aid, forming an inclined surface where the outer surface of the visor and the outer circumferential surface of the tip of the insertion aid are connected. This further reduces the resistance felt by the patient when inserting the anal dilation device.

[0013] In an anal dilator according to one embodiment of the present invention, the main body of the insertion aid is formed in a tapered shape such that its outer diameter decreases toward the tip, and the anal dilator may have an outer peripheral surface that slopes toward the other end from the base of the visor so as to conform to the tapered shape of the main body of the insertion aid.

[0014] In this configuration, the insertion aid is attached to the anal dilator by tapered fitting. This prevents the interface between the anal dilator and the insertion aid from slipping during insertion of the anal dilator, thus preventing the insertion aid from being overinserted.

[0015] In an anal dilator according to one embodiment of the present invention, the inclination angle of the visor portion with respect to the radial direction of the anal dilator coincides with the inclination angle of the tip portion with respect to the radial direction of the insertion aid, and the outer surface of the visor portion may form a flat surface continuous with the outer circumferential surface of the tip portion.

[0016] Furthermore, "the angles of inclination match" includes cases where the angle of inclination of the eaves is the same as the angle of inclination of the tip, or where the difference between the two angles of inclination is less than 3°.

[0017] This configuration eliminates the step at the boundary between the insertion aid and the anal dilator, providing a flat, inclined surface where the outer surface of the visor and the outer surface of the insertion aid are integrated. As a result, the anal dilator can be inserted into the anus very smoothly.

[0018] In an anal opening device according to one embodiment of the present invention, the auxiliary side mating surface is continuous from the lower end of the outer peripheral surface of the tip portion, extends in a direction intersecting the radial direction of the main body of the insertion auxiliary device, and includes a first surface that is partially exposed from the tip of the visor portion, and may be continuous in the order of the outer peripheral surface of the tip portion, the first surface, and the outer surface of the visor portion.

[0019] In the anal dilation device according to one embodiment of the present invention, the inclination angle of the gluteal part with respect to the radial direction of the anal dilator may be larger than the inclination angle of the tip part with respect to the radial direction of the insertion aid.

[0020] In the anal dilation device according to one embodiment of the present invention, the mating surface on the aid side may include a first surface that is a plane perpendicular to the radial direction of the main body of the insertion aid, and a second surface that is an inclined surface inclined outward from the perpendicular plane.

[0021] In the anal dilation device according to one embodiment of the present invention, the anal dilator includes a tapered portion whose wall thickness gradually becomes thinner so that the outer diameter becomes smaller from the other end side toward the one end side, and the outer surface of the tapered portion may be continuous with the outer peripheral surface of the tip portion as the inclined surface.

[0022] According to this configuration, the anal dilator is formed in a tapered shape. Thereby, the step between the outer surface of the tapered portion and the outer peripheral surface of the tip portion of the insertion aid can be alleviated. As a result, the resistance felt by the patient during the insertion of the anal dilation device can be reduced.

[0023] In the anal dilation device according to one embodiment of the present invention, a plate-like stopper portion that projects outward in the radial direction of the anal dilator may be formed at the other end of the anal dilator.

[0024] According to this configuration, over-insertion of the anal dilator can be prevented by the stopper portion.

[0025] In the anal dilation device according to one embodiment of the present invention, the stopper portion may integrally include an inclined plate that is inclined with respect to the radial direction of the anal dilator, and a horizontal plate that projects along the horizontal direction from the inclined plate.

[0026] According to this configuration, the inclined plate of the anal dilator can be fitted to the shape of the buttocks, and over-insertion of the anal dilator can be reliably prevented by the horizontal plate.

[0027] In the anal dilation device according to one embodiment of the present invention, the stopper portion may include a flange portion formed in an annular shape along the outer periphery of the anal dilator.

[0028] This configuration eliminates the need to worry about the orientation of the anal dilator when inserting it into the anus, thus improving the ease of insertion.

[0029] An anal dilator according to one embodiment of the present invention may further include a locking mechanism comprising a claw portion that protrudes laterally from the main body of the insertion aid, and a claw receiving portion formed on the lower surface of the stopper portion, which locks the claw portion that has been slid into the anal dilator by rotating the insertion aid.

[0030] With this configuration, the insertion aid and the anal dilator are connected by a locking mechanism, and this connection can be maintained until the anal dilator is fully placed. Therefore, the ease of inserting the anal dilator can be improved. In addition, the locking mechanism is a rotary slide type, and the direction in which the locking mechanism is released is different from the direction in which the anal dilator is inserted. Therefore, the locking mechanism can be released and the insertion aid can be retrieved without applying force in the anterior-posterior direction to the placed anal dilator. As a result, discomfort to the patient can be prevented when retrieving the insertion aid.

[0031] In the anal dilator according to one embodiment of the present invention, the length from the stopper portion to the one end of the anal dilator may be 20 mm or more and 45 mm or less.

[0032] In the anal opening device according to one embodiment of the present invention, the inclination angle of the tip portion of the insertion aid with respect to the radial direction may be 45° or more and 80° or less.

[0033] In the anal dilator according to one embodiment of the present invention, the outer diameter of the anal dilator may be 50 mm or less.

[0034] Figure 1 is a perspective view of the first embodiment of the anal opening device. Figure 2 is a plan view of the first embodiment of the anal opening device. Figure 3 is a side view of the first embodiment of the anal opening device. Figure 4 is a side view of the first embodiment of the anal opening device. Figure 5 is a cross-sectional view of Figure 2 at the VV cross-section. Figure 6 is an enlarged view of the portion enclosed by the dashed line VI in Figure 5. Figure 7 is a cross-sectional view of Figure 2 at the VII-VII cross-section. Figure 8 is a perspective view illustrating the assembly method of the anal opening device. Figure 9 is a perspective view illustrating the assembly method of the anal opening device. Figure 10A is a diagram illustrating the method of implanting the anal opening device in the anus. Figure 10B is a diagram illustrating the method of implanting the anal opening device in the anus. Figure 10C is a diagram illustrating the method of implanting the anal opening device in the anus. Figure 11 is a diagram showing a modified example of the anal opening device. Figure 12 is a perspective view of the second embodiment of the anal opening device. Figure 13 is a plan view of the second embodiment of the anal opening device. Figure 14 is a bottom view of the anal opening device according to the second embodiment. Figure 15 is a side view of the anal opening device according to the second embodiment. Figure 16 is a cross-sectional view of Figure 15 at the XVI-XVI cross-section. Figure 17 is an enlarged view of the area enclosed by the dashed line XVII in Figure 16. Figure 18 is a perspective view of the anal opening device according to the third embodiment. Figure 19 is a top view of the anal opening device according to the third embodiment. Figure 20 is a bottom view of the anal opening device according to the third embodiment. Figure 21 is a side view of the anal opening device according to the third embodiment. Figure 22 is a cross-sectional view of Figure 21 at the XXII-XXII cross-section. Figure 23 is an enlarged view of the area enclosed by the dashed line XXIII in Figure 22. Figure 24 is a perspective view of the anal opening device according to the fourth embodiment. Figure 25 is a top view of the anal opening device according to the fourth embodiment. Figure 26 is a side view of the anal opening device according to the fourth embodiment. Figure 27 is a cross-sectional view of Figure 26 at the XXVII-XXVII cross-section. Figure 28 is an enlarged view of the area enclosed by the dashed line XXVIII in Figure 27. Figure 29 is a perspective view of the anal opening device according to the fifth embodiment. Figure 30 is a side view of the anal opening device according to the fifth embodiment. Figure 31 is a cross-sectional view of the XXXI-XXXI section of Figure 30. Figure 32 is an enlarged view of the area enclosed by the dashed line XXXII in Figure 31.

[0035] Next, embodiments of the present invention will be described in detail with reference to the accompanying drawings.

[0036] (1) First Embodiment Figure 1 is a perspective view of the anal opening device 1A according to the first embodiment. Figure 2 is a plan view of the anal opening device 1A according to the first embodiment. Figure 3 is a side view of the anal opening device 1A according to the first embodiment. Figure 4 is a side view of the anal opening device 1A according to the first embodiment. Figure 5 is a cross-sectional view of the A-A section of Figure 2. Figure 6 is an enlarged view of the portion enclosed by the dashed line VI of Figure 5. Figure 7 is a cross-sectional view of the VII-VII section of Figure 2. Figures 8 and 9 are perspective views illustrating the assembly method of the anal opening device 1A. Figures 10A to 10C are diagrams illustrating the method of implanting the anal opening device 1A into the anus 38.

[0037] Referring to Figures 1 to 7, the anal dilation device 1A is a device for, for example, dilating the anus of a human body and maintaining the dilated state. The application of the anal dilation device 1A is not limited to humans, but may also include dogs, cats, horses, and other mammals. By dilating the anus with the anal dilation device 1A, procedures such as manual disimpaction, surgical procedures and examinations of the anus and rectum can be performed smoothly. The anal dilation device 1A may be called a "disimpaction device," "anal dilator," "anoscope," etc., depending on its use. Note that manual disimpaction may be a procedure in which stool in the rectum is removed using a finger, a spoon, or other scraping device.

[0038] The anal dilator 1A includes a detachably assembled anal dilator 2 and an insertion aid 3. The anal dilator 1A is assembled by inserting the insertion aid 3 into the cylindrical anal dilator 2 so that its tip 5 is exposed.

[0039] The materials for the anal dilator 2 and insertion aid 3 are not particularly limited, as long as they are biologically safe. Examples of materials for the anal dilator device 1A include general-purpose resins such as polyethylene resin (PE) and polypropylene resin (PP), engineering plastics such as polyacetal (POM) and polycarbonate (PC), and soft resins such as silicone and polyurethane (PU). The anal dilator 2 and insertion aid 3 can be manufactured by various methods. Examples of manufacturing methods for the anal dilator 2 and insertion aid 3 include 3D printing, cutting of resin materials, and injection molding.

[0040] The insertion aid 3 is a component that assists in inserting and leaving the anal dilator 2 into the anus, and is formed in a shape that narrows at the tip 5. The insertion aid 3 includes an aid body 4, a tip 5, and a gripping portion 6. The insertion aid 3 is formed in a cylindrical shape with the end on the tip 5 side closed and the end on the gripping portion 6 side open.

[0041] In the assembled state of the anal dilator device 1A, the auxiliary device body 4 covers the anal dilator 2, the tip portion 5 protrudes from the upper side of the anal dilator 2, and the gripping portion 6 protrudes from the lower side of the anal dilator 2. The thickness of the insertion aid 3 is not limited as long as it does not deform even when gripped with a moderate amount of force, for example, it is 1.0 mm or more and 2.0 mm or less, and preferably 1.2 mm or more and 1.8 mm or less.

[0042] The auxiliary device body 4 is formed in a cylindrical shape having approximately the same outer diameter toward the tip portion 5. The outer circumferential surface 7 of the auxiliary device body 4 may be inclined by several degrees with respect to the axial direction of the auxiliary device body 4. The dimensions of the auxiliary device body 4 are designed to match the dimensions of the anal dilator 2 (described later), so that the outer circumferential surface 7 of the auxiliary device body 4 is in close contact with the inner circumferential surface 28 of the anal dilator 2.

[0043] The tip portion 5 extends conically from one end of the main body 4 of the auxiliary tool. The tip surface 9 of the tip portion 5 is rounded. The curvature of the tip portion 5 is, for example, R １ The outer diameter D of the tip portion 5 is 8.0 mm or more and 12.0 mm or less, preferably 8.5 mm or more and 12.0 mm or less. １(See Figure 3), for example, 27 mm to 33 mm, preferably 28 mm to 32 mm. Height H of the tip portion 5 １ (See Figure 4) is, for example, 15.0 mm to 35.0 mm, preferably 17.0 mm to 25.0 mm. The inclination angle θ of the tip portion 5 １ The inclination angle of the insertion aid 3 with respect to the radial direction is, for example, 45° or more and 80° or less, preferably 55° or more and 70° or less.

[0044] The insertion aid 3 has a stepped portion 10 at the boundary between the tip portion 5 and the aid body 4. The stepped portion 10 has an aid side mating surface 11 formed in an annular concave shape along the outer circumference of the insertion aid 3. The aid side mating surface 11 is located inside the stepped portion 10 and is the surface responsible for aligning the insertion aid 3 with the anal dilator 2.

[0045] The mating surface 11 on the auxiliary tool side includes a first surface 12 and a second surface 13 that is inclined or perpendicular to the first surface 12. The first surface 12 is continuous from the lower end of the outer peripheral surface 8 (outer peripheral inclined surface) of the tip portion 5, and the second surface 13 is continuous with the upper end of the outer peripheral surface 7 of the auxiliary tool body 4. In this embodiment, the first surface 12 is a surface perpendicular to the radial direction of the insertion auxiliary tool 3, and the second surface 13 is an inclined surface that slopes outward from the said vertical surface. More specifically, the mating surface 11 on the auxiliary tool side includes a first surface 12, which is an annular vertical surface extending integrally from the lower end of the outer peripheral surface 8 (conical surface) of the tip portion 5, and a second surface 13, which is an annular tapered surface extending uniformly outward integrally from the lower end of the said annular vertical surface. The first surface 12 and the second surface 13 may be referred to as the first mating surface and the second mating surface, respectively.

[0046] The first surface 12 and the second surface 13 do not necessarily have to be a vertical and inclined surface, respectively. For example, the first surface 12 may be an inclined surface with respect to the axial direction of the insertion aid 3, and the second surface 13 may be a horizontal surface along the radial direction of the insertion aid 3. Furthermore, the mating surface 11 on the aid side does not need to be divided into multiple surfaces like the first surface 12 and the second surface 13, and may be a single annular mating surface that fits the mating surface 24 on the expander side, which will be described later.

[0047] As shown in Figure 6, the height H of the mating surface 11 on the auxiliary device side is shown. ２In this configuration, the height of the first surface 12 is, for example, 2.5 mm to 5.0 mm, preferably 3.0 mm to 4.0 mm. If the height of the auxiliary device side mating surface 11 is within this range, the feeling of snagging or pain experienced by the patient when inserting the anal opening device 1A into the anus can be reduced.

[0048] The gripping portion 6 is the handle portion used when inserting the anal opening device 1A into the anus.

[0049] A non-slip portion 15 is formed on the outer circumferential surface 14 of the gripping portion 6. The non-slip portion 15 includes protrusions that are projected outward from the outer circumferential surface 14 of the gripping portion 6. In this embodiment, a rib, which is a linear protrusion, is formed protruding from the outer circumferential surface 14 of the gripping portion 6. More specifically, the non-slip portion 15 is formed consisting of a plurality of ribs (transverse ribs) extending along the circumferential direction of the gripping portion 6. The plurality of ribs are arranged at intervals in the axial direction of the gripping portion 6. The plurality of ribs may be annular ribs formed around the entire circumference of the outer circumferential surface 14 of the gripping portion 6, as shown in the figure, or, although not shown, may be linear ribs having one end and the other, partially formed in the circumferential direction of the outer circumferential surface 14 of the gripping portion 6.

[0050] The anti-slip portion 15, although not shown in the figure, may be, for example, a plurality of ribs (longitudinal ribs) extending along the axial direction of the gripping portion 6, or a plurality of dot-shaped protrusions. Furthermore, the anti-slip portion 15 may be a roughened surface formed by, for example, a physical or chemical roughening treatment.

[0051] The anal dilator 2 is a component that is placed in the anus and maintains the anus in a dilated state, and is cylindrical in shape with a tip portion 16 (one end) and a base portion 17 (the other end). The tip portion 16 is the part that is pushed into the inside of the anus, and the base portion 17 is the part that is exposed to the outside of the anus. The anal dilator 2 integrally includes a dilator body 18 and a stopper portion 19. The tip portion and base portion of the dilator body 18 coincide with the tip portion 16 and base portion 17 of the anal dilator 2, and the stopper portion 19 is positioned on the base portion 17 of the dilator body 18.

[0052] The dilator body 18 is formed in a cylindrical shape having substantially the same outer diameter from the base end portion 17 side toward the tip end portion 16 side. The outer peripheral surface 20 of the dilator body 18 may be a surface inclined by about several degrees with respect to the axial direction of the dilator body 18. The outer diameter D of the dilator body 18 ２ (see FIG. 7), for example, is 50 mm or less, preferably 30 mm or more and 40 mm or less, and more preferably 33 mm or more and 37 mm or less. The height H of the dilator body 18 ３ (see FIG. 3), for example, is 25 mm or more and 45 mm or less, preferably 30 mm or more and 40 mm or less.

[0053] An annular flange portion 22 that forms the opening 21 of the dilator body 18 is formed at the tip end portion 16 of the dilator body 18. The flange portion 22 projects inward from the tip end portion 16 of the dilator body 18 over the entire circumference of the dilator body 18. In this form, the flange portion 22 is configured as an inward flange formed by bending a part of the tip end portion 16 of the dilator body 18 inward over the entire circumference. The flange portion 22 includes an inclined surface 23 (inclined wall) inclined inward with respect to the outer peripheral surface 20 (outer peripheral wall) along the axial direction of the dilator body 18.

[0054] The inner diameter D of the tip end portion 16 of the dilator body 18 formed by the flange portion 22 ３ (see the diameter of the opening 21 in FIG. 7) is, for example, 20 mm or more and 40 mm or less, preferably 25 mm or more and 35 mm or less. Also, the inclination angle θ of the flange portion 22 ２ (the inclination angle of the inclined surface 23 (outer surface) of the flange portion 22 with respect to the radial direction of the dilator body 18) is the same as the inclination angle θ of the tip end portion 5 of the insertion aid 3 １ and is, for example, 45° or more and 80° or less, preferably 55° or more and 70° or less.

[0055] The inner surface of the visor portion 22 is the surface responsible for aligning the insertion aid 3 and the anal dilator 2, and may be called the dilator-side mating surface 24. The dilator-side mating surface 24 is the surface that fits with the aid side mating surface 11. The dilator-side mating surface 24 includes a first surface 25 and a second surface 26 that is inclined or perpendicular to the first surface 25. The first surface 25 is continuous with the tip 27 of the visor portion 22, and the second surface 26 is continuous with the upper end of the inner circumferential surface 28 of the dilator body 18. In this embodiment, the first surface 25 is a surface perpendicular to the radial direction of the anal dilator, and the second surface 26 is an inclined surface that slopes outward from the said vertical surface. More specifically, the dilator-side mating surface 24 includes a first surface 25 which is an annular vertical surface extending integrally from the annular tip of the visor portion 22, and a second surface 26 which is an annular tapered surface extending uniformly outward integrally from the lower end of the said annular vertical surface. The first surface 25 and the second surface 26 may also be referred to as the first mating surface and the second mating surface, respectively.

[0056] The first surface 25 and the second surface 26 do not necessarily have to be a vertical and inclined surface, respectively. For example, the first surface 25 may be an inclined surface with respect to the axial direction of the anal dilator 2, and the second surface 26 may be a horizontal surface along the radial direction of the anal dilator 2. Also, the dilator-side mating surface 24 does not need to be distinguished into multiple surfaces like the first surface 25 and the second surface 26, and may be a single annular mating surface that fits the auxiliary device-side mating surface 11.

[0057] As shown in Figure 6, the height H of the expansion unit side mating surface 24 is shown. ４ (In this configuration, the height of the first surface 25) is the height H of the auxiliary device side mating surface 11. ２ It is the same as, for example, 2.5 mm to 5.0 mm, preferably 3.0 mm to 4.0 mm. Also, the tip 27 of the visor portion 22 is rounded. The roundness of the tip is, for example, R ２ The thickness is 0.1 mm or more and 0.5 mm or less, preferably 0.2 mm or more and 0.3 mm or less.

[0058] The stopper portion 19 is plate-shaped and extends radially outward from the outer peripheral surface 20 of the dilator body 18. In this configuration, multiple stopper portions 19 are formed as horizontal plates extending laterally from the dilator body 18. More specifically, a pair of stopper portions 19 are formed extending radially outward from one side and the other side of the dilator body 18. Since the stopper portions 19 are not formed around the entire circumference of the dilator body 18, by aligning the longitudinal direction of the stopper portion 19 with the direction of the gluteal cleft, the stopper portion 19 is less likely to come into contact with the buttocks when inserting the anal dilator, allowing for smoother insertion.

[0059] Length L of the stopper part 19 １ For example, it is 80 mm to 110 mm, preferably 90 mm to 100 mm. The length of the stopper portion 19 may be the length from the end of one stopper portion 19 to the end of the other stopper portion 19. The width W of the stopper portion 19 １ For example, the width of the stopper portion 19 is 20 mm to 40 mm, preferably 25 mm to 35 mm. If the width of the stopper portion 19 is within this range, the anal dilator can adequately press against the buttocks surrounding the anus when it is placed in the anus, and the field of view around the anus is widened. Therefore, subsequent procedures such as manual disimpaction and surgical operations can be performed smoothly.

[0060] The anal dilation device 1A may further include a locking mechanism for locking the connection between the insertion aid 3 and the anal dilator 2. Below, the structure and usage of a locking mechanism 29 will be described as an example of a locking mechanism, but the locking mechanism is not limited to locking mechanism 29. Furthermore, the anal dilation device 1A may not have a locking mechanism.

[0061] The locking mechanism 29 consists of a claw portion 30 on the insertion aid 3 side and a claw receiving portion 31 on the anal dilator 2 side.

[0062] Multiple claw portions 30 are formed on the outer circumferential surface 7 of the auxiliary tool body 4. The multiple claw portions 30 are horizontal plate-shaped portions that protrude laterally from the auxiliary tool body 4. In this configuration, a pair of claw portions 30 are formed, each protruding radially outward from one side and the other side of the auxiliary tool body 4.

[0063] Multiple claw receiving portions 31 are formed on the lower surface 32 of the stopper portion 19. Each of the multiple claw receiving portions 31 has a locking groove 33 that is box-shaped and partitioned from the side and below by walls protruding from the lower surface 32 of the stopper portion 19. In this configuration, one claw receiving portion 31 is provided on each of the stopper portions 19. The walls of each pair of claw receiving portions 31 include a guide wall 34, a locking wall 35, and a bottom wall 36, and these are arranged in an L-shape in plan view, thereby partitioning the locking groove 33.

[0064] The guide wall 34 is formed linearly in the width direction of the stopper portion 19. The locking wall 35 is the portion of the wall that is bent at one end of the guide wall 34 in a direction perpendicular to the width direction of the stopper portion 19. The pair of locking walls 35 are positioned at opposite ends of the stopper portion 19 in the width direction. As a result, the locking groove 33 of one claw receiving portion 31 is open on one side in the width direction of the stopper portion 19, and the locking groove 33 of the other claw receiving portion 31 is open on the other side in the width direction of the stopper portion 19. As a result, by rotating the insertion aid 3 relative to the anal dilator 2, the claw portion 30 can be slid into the claw receiving portion 31 (locking groove 33).

[0065] The overall height H of the anal dilator, including the amount of protrusion of the claw receiving portion 31 described above. ５ (See Figure 3) For example, it is 30 mm or more and 50 mm or less, preferably 35 mm or more and 45 mm or less.

[0066] The stopper portion 19 has an opening 37 formed at a position opposite to the claw receiving portion 31. One opening 37 is formed for each claw receiving portion 31. The locked state of the locking mechanism 29 can be confirmed through the opening 37.

[0067] To assemble the anal dilator 1A, refer to Figure 8 and insert the tip 5 of the insertion aid 3 into the opening 21 of the anal dilator 2. Insertion should be continued until the mating surface 24 on the dilator side fits into the mating surface 11 on the aid side and the visor portion 22 engages with the stepped portion 10 of the insertion aid. Then, refer to Figure 9 and rotate the insertion aid 3 relative to the anal dilator 2. This causes each claw portion 30 of the insertion aid 3 to be guided by the guide wall 34 of each claw receiving portion 31 and inserted into the locking groove 33, and locked in place by the locking wall 35.

[0068] To use the anal dilator 1A, refer to Figure 10A and align the assembled anal dilator 1A (anal dilator 2 and insertion aid 3) so that the longitudinal direction of the stopper portion 19 aligns with the direction of the gluteal cleft 64. Next, refer to Figure 10B and insert the tip 5 of the insertion aid 3 into the patient's anus 38. After inserting the aid body 4 until it reaches the inside of the anus 38, the anal dilator 2 can be left inside the anus 38 by releasing the locking mechanism 29 and removing the insertion aid 3, as shown in Figure 10C. This expands the anus 38, allowing procedures such as manual disimpaction, surgical procedures and examinations of the anus and rectum to be performed smoothly. Furthermore, by applying a lubricant such as lidocaine jelly to the tip 5 and outer surface 8 of the insertion aid 3 before insertion, frictional resistance during insertion can be reduced, improving the ease of insertion.

[0069] With the anal dilator device 1A, as shown in Figures 5 and 6, the visor portion 22 of the anal dilator 2 engages with the stepped portion 10 of the insertion aid 3, forming an inclined surface 39 where the inclined surface 23 of the visor portion 22 and the outer peripheral surface 8 of the tip portion 5 of the insertion aid 3 are integrated. This reduces the resistance felt by the patient when the boundary between the insertion aid 3 and the anal dilator 2 comes into contact with the area around the anus 38. As a result, the anal dilator device 1A can be smoothly inserted into the anus 38, reducing the pain felt by the patient.

[0070] Furthermore, as shown in Figure 6, the inclination angle θ of the tip 5 of the insertion aid 3 １ and the inclination angle θ of the eaves portion 22 ２These coincide, and the inclined surface 23 of the visor portion 22 and the outer peripheral surface 8 of the tip portion 5 form a continuous flat inclined surface 39. This eliminates the step at the boundary between the insertion aid 3 and the anal dilator 2, providing a flat inclined surface 39 where the inclined surface 23 of the visor portion 22 and the outer peripheral surface 8 of the tip portion 5 are integrated. As a result, the anal opening device 1A can be inserted into the anus 38 very smoothly.

[0071] In Figure 6, a small gap 40 is shown between the inclined surface 23 of the eaves portion 22 and the outer peripheral surface 8 of the tip portion 5. However, this gap 40 is not large enough to cause discomfort to the patient and is clearly distinct from a "step" that would cause the patient to feel a sense of catching or tension.

[0072] Referring to Figure 11, a modified example of the area around the engagement portion between the visor portion 22 of the anal dilator 2 and the stepped portion 10 of the insertion aid 3 will be explained. For example, the height H of the mating surface 24 on the dilator side. ４ The height H of the mating surface 11 on the auxiliary device side. ２ It does not need to be the same as, height H ２ It can be smaller than this. For example, height H ４ is, height H ２ It may be 0.5 mm to 1.5 mm smaller than this. As a result, the first surface 12 of the auxiliary tool side mating surface 11 may be partially exposed from the tip 27 of the visor portion 22. Consequently, the outer peripheral surface 8 of the tip portion 5, the first surface 12 of the auxiliary tool side mating surface 11, and the inclined surface 23 of the visor portion 22 are continuous in that order.

[0073] Furthermore, the inclination angle θ of the eaves portion 22 ２ The inclination angle θ of the tip 5 of the insertion aid 3. １ It does not need to be the same as, the inclination angle θ １ It can be larger than that. For example, the inclination angle θ ２ The inclination angle θ １ It may be greater than or equal to 1° by 5°.

[0074] In this configuration, a small step 63 remains at the boundary between the insertion aid 3 and the anal dilator 2, but the resistance felt by the patient when the boundary between the insertion aid 3 and the anal dilator 2 comes into contact with the area around the anus 38 can be sufficiently reduced.

[0075] In particular, the anal opening device 1A can be suitably used as a device for manual disimpaction. Traditionally, manual disimpaction has been performed for patients with chronic constipation. Manual disimpaction is necessary for patients with severe chronic constipation to prevent fecal intestinal obstruction, etc. In recent years, more than several million manual disimpaction procedures are performed in medical institutions every year, and this is expected to increase further in the future due to the aging population. Therefore, this anal opening device 1A can greatly reduce the burden on patients who require manual disimpaction, and at the same time, it can greatly reduce the burden on medical professionals who perform manual disimpaction.

[0076] Furthermore, since the anal dilator 2 is equipped with a visor 22, the anal dilator 2 can also be prevented from being overinserted.

[0077] Furthermore, since the stopper portion 19 is a pair of plate-shaped parts that protrude from the expander body 18 in opposite directions, a plastic bag or the like can be hooked onto it during manual disimpaction. This prevents stool from scattering or sticking to the body during manual disimpaction. As a result, cleaning time after manual disimpaction can be shortened, and the spread of odor can be reduced.

[0078] Furthermore, the anal dilation device 1A is equipped with a locking mechanism 29 for locking the connection between the insertion aid 3 and the anal dilator 2. Since the insertion aid 3 and the anal dilator 2 are connected by the locking mechanism 29, this connection can be maintained until the anal dilator 2 is fully placed. This improves the ease of insertion of the anal dilation device 1A. In addition, the locking mechanism 29 is a rotary slide type, and the direction in which the locking mechanism 29 is released is different from the insertion direction of the anal dilation device 1A. Therefore, the locking mechanism 29 can be released and the insertion aid 3 can be retrieved without applying force in the forward or backward direction to the placed anal dilator 2. As a result, discomfort to the patient can be prevented when retrieving the insertion aid 3.

[0079] (2) Second Embodiment Figure 12 is a perspective view of the anal opening device 1B according to the second embodiment. Figure 13 is a plan view of the anal opening device 1B according to the second embodiment. Figure 14 is a bottom view of the anal opening device 1B according to the second embodiment. Figure 15 is a side view of the anal opening device 1B according to the second embodiment. Figure 16 is a cross-sectional view of the XVI-XVI section of Figure 15. Figure 17 is an enlarged view of the portion enclosed by the dashed line XVII in Figure 16. In Figures 12 to 17, components corresponding to the components described in Figures 1 to 11 are given the same reference numerals as in Figures 1 to 11, and detailed explanations are omitted.

[0080] The anal dilating device 1B has a tip 5 that is slightly more pointed than that of the anal dilating device 1A. The roundness of the tip 5 of the anal dilating device 1B is, for example, R ３ The diameter is 5.0 mm or more and 9.0 mm or less, preferably 6.0 mm or more and 8.0 mm or less.

[0081] The auxiliary body 4 of the anal opening device 1B is tapered so that its outer diameter decreases from the gripping portion 6 side to the tip portion 5 side. Refer to Figure 16, the outer diameter D of the tip portion 5. ４ For example, it is 27 mm or more and 33 mm or less, preferably 28 mm or more and 32 mm or less. On the other hand, the outer diameter D of the gripping portion 6 ５ For example, it is 30 mm or more and 36 mm or less, preferably 31 mm or more and 35 mm or less.

[0082] The anal dilator 2 has an outer peripheral surface 20 that slopes from the tip 16 (base of the visor 22) toward the base end 17 of the dilator body 18, so as to conform to the tapered shape of the auxiliary device body 4.

[0083] The stopper portion 19 of the anal dilator device 1B is a flange portion 41 formed in an annular shape along the outer circumference of the anal dilator 2. In this configuration, the flange portion 41 is formed in an annular shape around the base end portion 17 of the dilator body 18.

[0084] In addition to the effects exhibited by the anal dilator 1A, the anal dilator 1B can exhibit the following effects. For example, the insertion aid 3 and the anal dilator 2 are formed in a tapered shape, and the insertion aid 3 is assembled to the anal dilator 2 by tapered fitting. This prevents the interface between the anal dilator 2 and the insertion aid 3 from slipping and causing only the insertion aid 3 to be overinserted when the anal dilator 1B is inserted.

[0085] Furthermore, since the stopper portion 19 is an annular flange portion 41, there is no need to worry about the orientation of the anal opening device 1B when inserting it into the anus 38. As a result, the ease of inserting the anal opening device 1B can be improved.

[0086] (3) Third Embodiment Figure 18 is a perspective view of the anal opening device 1C according to the third embodiment. Figure 19 is a plan view of the anal opening device 1C according to the third embodiment. Figure 20 is a bottom view of the anal opening device 1C according to the third embodiment. Figure 21 is a side view of the anal opening device 1C according to the third embodiment. Figure 22 is a cross-sectional view of the XXII-XXII section of Figure 21. Figure 23 is an enlarged view of the portion enclosed by the dashed line XXIII in Figure 22. In Figures 18 to 23, components corresponding to the components described in Figures 1 to 11 are given the same reference numerals as in Figures 1 to 11, and detailed explanations are omitted.

[0087] The anal dilating device 1C has a tip 5 that is slightly more pointed than that of the anal dilating device 1A. The roundness of the tip 5 of the anal dilating device 1C is, for example, R ４ The diameter is 5.0 mm or more and 9.0 mm or less, preferably 6.0 mm or more and 8.0 mm or less.

[0088] The auxiliary device body 4 of the anal opening device 1C is tapered in shape so that the outer diameter decreases from the gripping portion 6 side to the tip portion 5 side. Refer to Figure 22, the outer diameter D of the tip portion 5. ６ For example, it is 27 mm or more and 33 mm or less, preferably 28 mm or more and 32 mm or less. On the other hand, the outer diameter D of the gripping portion 6 ７ For example, it is 30 mm or more and 36 mm or less, preferably 31 mm or more and 35 mm or less.

[0089] The anal dilator 2 has an outer peripheral surface 20 that slopes from the tip 16 (base of the visor 22) toward the base end 17 side of the dilator body 18, following the tapered shape of the auxiliary device body 4. Furthermore, the anal dilator 2 includes a tapered portion 42 in which the wall thickness gradually decreases from the base end 17 side toward the tip 16 side of the dilator body 18 so that the outer diameter decreases. Referring to Figure 23, for example, the thickness T of the dilator body 18 on the base end 17 side. １ The thickness T of the expander body 18 on the tip portion 16 side is 1.0 mm or more and 2.0 mm or less, preferably 1.2 mm or more and 1.8 mm or less. ２ The diameter is 0.4 mm or more and 1.4 mm or less, preferably 0.6 mm or more and 1.2 mm or less.

[0090] The outer circumferential surface 8 of the tip portion 5 of the insertion aid 3 has a lower outer circumferential surface 43 with a slope approximately the same as the slope of the tapered portion 42, near the boundary with the tip portion 16 of the expander body 18. The outer circumferential surface 44 of the tapered portion 42 forms an inclined surface that continues from the lower outer circumferential surface 43 of the tip portion 5 with approximately the same slope. In Figure 23, it appears that there is a step between the lower outer circumferential surface 43 of the tip portion 5 and the outer circumferential surface 44 of the tapered portion 42, equal to the thickness of the tip of the tapered portion 42. However, this is not a thickness that would cause discomfort to the patient, and it is clearly distinct from a "step" that would cause the patient to feel a catching or tight sensation.

[0091] The stopper portion 19 of the anal dilator device 1C integrally includes an inclined plate 46 that is inclined with respect to the radial direction of the anal dilator 2, and horizontal plates 45 and 47 that extend horizontally from the inclined plate 46. More specifically, the stopper portion 19 includes a pair of first horizontal plates 45 that extend laterally from the base end 17 of the dilator body 18, a pair of inclined plates 46 that are inclined outward from the pair of first horizontal plates 45, and a second horizontal plate 47 that further extends horizontally from the pair of inclined plates 46. As a result, the stopper portion 19 is formed in a crank shape. The locking mechanism 29 is formed on the lower surface 32 of the first horizontal plate 45.

[0092] The anal dilator device 1C can exhibit the following effects in addition to those exhibited by the anal dilator device 1A. For example, the outer circumferential wall of the anal dilator 2 is tapered. This reduces the step between the outer circumferential surface 44 of the tapered portion 42 and the outer circumferential surface 8 (lower outer circumferential surface 43) of the tip portion 5 of the insertion aid 3. As a result, the discomfort felt by the patient after the anal dilator 2 is placed in the anus 38 can be reduced.

[0093] Furthermore, the stopper portion 19 is formed in a crank shape including an inclined plate 46. This allows the inclined plate 46 of the anal dilator 2 to fit the shape of the buttocks, and the second horizontal plate 47 reliably prevents overinsertion of the anal dilator 2.

[0094] (4) Fourth Embodiment Figure 24 is a perspective view of the anal opening device 1D according to the fourth embodiment. Figure 25 is a plan view of the anal opening device 1D according to the fourth embodiment. Figure 26 is a side view of the anal opening device 1D according to the fourth embodiment. Figure 27 is a cross-sectional view of the section XXVII-XXVII of Figure 26. Figure 28 is an enlarged view of the portion enclosed by the dashed line XXVIII of Figure 27. In Figures 24 to 28, components corresponding to the components described in Figures 1 to 11 are given the same reference numerals as in Figures 1 to 11, and detailed explanations are omitted.

[0095] The anal dilating device 1D has a tip 5 that is slightly more pointed than the anal dilating device 1A. The roundness of the tip 5 of the anal dilating device 1D is, for example, R ５ The diameter is 5.0 mm or more and 9.0 mm or less, preferably 6.0 mm or more and 8.0 mm or less. Furthermore, the anal opening device 1D has a tip portion 5 with a steeper incline than the anal opening device 1A. Inclination angle θ of the tip portion 5 of the anal opening device 1D ３ (See Figure 28), for example, it is between 65° and 80°.

[0096] The anal dilator 2 includes a tapered section 42 in which the thickness of the dilator body 18 gradually decreases from the base end 17 side to the tip end 16 side, so that the outer diameter decreases. For example, the thickness T of the dilator body 18 at the base end 17 side. ３The thickness T of the expander body 18 on the tip portion 16 side is 1.0 mm or more and 2.0 mm or less, preferably 1.2 mm or more and 1.8 mm or less. ４ The diameter is 0.4 mm or more and 1.4 mm or less, preferably 0.6 mm or more and 1.2 mm or less.

[0097] The outer circumferential surface 8 of the tip portion 5 of the insertion aid 3 has a lower outer circumferential surface 49 with a slope approximately the same as the slope of the tapered portion 48, near the boundary with the tip portion 16 of the expander body 18. The outer circumferential surface 50 of the tapered portion 48 forms an inclined surface that extends from the lower outer circumferential surface 49 of the tip portion 5 with approximately the same slope. In Figure 28, it appears that there is a step between the lower outer circumferential surface 49 of the tip portion 5 and the outer circumferential surface 50 of the tapered portion 48, equal to the thickness of the tip of the tapered portion 48. However, this is not a thickness that would cause discomfort to the patient, and it is clearly distinct from a "step" that would cause the patient to feel a catching or tight sensation.

[0098] The stopper portion 19 of the anal dilator 1D integrally includes an inclined plate 51 that is inclined with respect to the radial direction of the anal dilator 2, and a horizontal plate 52 that extends horizontally from the inclined plate 51. More specifically, the stopper portion 19 includes a pair of inclined plates 51 that are inclined outward from the base end 17 of the dilator body 18, and a horizontal plate 52 that further extends horizontally from the pair of inclined plates 51. As a result, the stopper portion 19 is formed in a wing shape.

[0099] The locking mechanism 29 consists of a combination of multiple slide rails 53 on the insertion aid 3 side and multiple rail guides 54 on the anal dilator 2 side.

[0100] Multiple slide rails 53 are formed on the outer circumferential surface 7 of the auxiliary device body 4. The multiple slide rails 53 are curved rails that protrude laterally from the auxiliary device body 4. In this configuration, a pair of substantially semicircular slide rails 53 are formed, each protruding radially outward from one side and the other side of the auxiliary device body 4.

[0101] Multiple rail guides 54 protrude laterally inward from the inclined plate 51 of the stopper portion 19. The multiple rail guides 54 form a rail groove 55 between themselves and the lower surface 32 of the inclined plate 51. The slide rail 53 is slidably inserted into the rail groove 55. The anal opening device 1D has a gripping portion 6 that is longer vertically than the anal opening device 1A.

[0102] The anal dilator device 1D can exhibit the following effects in addition to those exhibited by the anal dilator device 1A. For example, the outer circumferential wall of the anal dilator 2 is tapered. This reduces the step between the outer circumferential surface 50 of the tapered portion 48 and the outer circumferential surface 8 (lower outer circumferential surface 49) of the tip portion 5 of the insertion aid 3. As a result, the discomfort felt by the patient after the anal dilator 2 is placed in the anus 38 can be reduced.

[0103] Furthermore, the stopper portion 19 is formed in a wing shape that includes an inclined plate 51. This allows the inclined plate 51 of the anal dilator 2 to fit the shape of the buttocks, and the horizontal plate 52 reliably prevents overinsertion of the anal dilator 2.

[0104] (5) Fifth Embodiment Figure 29 is a perspective view of the anal opening device 1E according to the fifth embodiment. Figure 30 is a side view of the anal opening device 1E according to the fifth embodiment. Figure 31 is a cross-sectional view of the XXXI-XXXI section of Figure 30. Figure 32 is an enlarged view of the portion enclosed by the dashed line XXXII in Figure 31. In Figures 29 to 32, components corresponding to the components described in Figures 1 to 11 are given the same reference numerals as in Figures 1 to 11, and detailed explanations are omitted.

[0105] The anal dilating device 1E has a tip 5 that is slightly more pointed than the anal dilating device 1A. The roundness of the tip 5 of the anal dilating device 1E is, for example, R ６ The diameter is 5.0 mm or more and 9.0 mm or less, preferably 6.0 mm or more and 8.0 mm or less. Furthermore, the anal opening device 1E has a tip portion 5 with a steeper incline than the anal opening device 1A. The incline angle θ of the tip portion 5 of the anal opening device 1E ４ For example, it is between 65° and 80°.

[0106] The anal dilator 2 includes a tapered section 56 in which the thickness of the dilator body 18 gradually decreases from the base end 17 side to the tip end 16 side, so that the outer diameter decreases. For example, the thickness T of the dilator body 18 at the base end 17 side. ５ The thickness T of the expander body 18 on the tip portion 16 side is 1.0 mm or more and 2.0 mm or less, preferably 1.2 mm or more and 1.8 mm or less. ６ The diameter is 0.4 mm or more and 1.4 mm or less, preferably 0.6 mm or more and 1.2 mm or less.

[0107] The outer circumferential surface 8 of the tip portion 5 of the insertion aid 3 has a lower outer circumferential surface 57 with a slope approximately the same as the slope of the tapered portion 56, near the boundary with the tip portion 16 of the expander body 18. The outer circumferential surface 58 of the tapered portion 56 forms an inclined surface that is continuous with the lower outer circumferential surface 57 of the tip portion 5 with approximately the same slope. In Figure 32, it appears that there is a step between the lower outer circumferential surface 57 of the tip portion 5 and the outer circumferential surface 58 of the tapered portion 56, equal to the thickness of the tip of the tapered portion 56. However, this is not a thickness that would cause discomfort to the patient, and is clearly distinct from a "step" that would cause the patient to feel a catching or tight sensation.

[0108] The stopper portion 19 of the anal dilator 1E integrally includes an inclined plate 59 that is inclined with respect to the radial direction of the anal dilator 2, and a horizontal plate 60 that extends horizontally from the inclined plate 59. More specifically, the stopper portion 19 includes an annular inclined plate 59 that is inclined outward from the base end 17 of the dilator body 18, and an annular horizontal plate 60 that further extends horizontally from the pair of inclined plates 59. As a result, the stopper portion 19 is formed in a flange shape.

[0109] The anal dilator 1E includes a projection 61 formed on the outer circumferential surface 7 of the auxiliary device body 4, instead of a locking mechanism 29. The projection 61 protrudes outward from the outer circumferential surface 7 of the auxiliary device body 4. The projection 61 contacts the inclined plate 59 of the anal dilator 2, preventing over-insertion of the insertion aid 3. The anal dilator 1E has a gripping portion 6 that is longer vertically than that of the anal dilator 1A.

[0110] The anal dilator 1E further includes a hook portion 62 attached to the anal dilator 2. The hook portion 62 is shaped to allow a finger to be hooked onto it.

[0111] In addition to the effects exhibited by the anal dilator 1A, the anal dilator 1E can exhibit the following effects. For example, the outer circumferential wall of the anal dilator 2 is tapered. This reduces the step between the outer circumferential surface 58 of the tapered portion 56 and the outer circumferential surface 8 (lower outer circumferential surface 57) of the tip portion 5 of the insertion aid 3. As a result, the discomfort felt by the patient after the anal dilator 2 is placed in the anus 38 can be reduced.

[0112] Furthermore, the stopper portion 19 is formed in a flange shape that includes an inclined plate 59. This allows the inclined plate 59 of the anal dilator 2 to fit the shape of the buttocks, and the horizontal plate 60 reliably prevents overinsertion of the anal dilator 2. In addition, because the stopper portion 19 has an annular flange shape, there is no need to worry about the orientation of the anal dilator 1E when inserting it into the anus 38. As a result, the ease of insertion of the anal dilator 1E can be improved.

[0113] Although embodiments of the present invention have been described, the present invention can also be implemented in other forms.

[0114] The embodiments of the present invention described herein are illustrative in all respects and should not be interpreted restrictively, and modifications are intended in all respects.

[0115] This application corresponds to Japanese Patent Application No. 2024-182547, filed with the Japan Patent Office on 18 October 2024, and the full disclosure of this application is incorporated herein by reference.

[0116] 1A: Anal dilator 1B: Anal dilator 1C: Anal dilator 1D: Anal dilator 1E: Anal dilator 2: Anal dilator 3: Insertion aid 4: Aid aid body 5: Tip 8: Outer surface 10: Step 11: Aid aid side mating surface 16: Tip 17: Base end 19: Stopper 21: Opening 22: Overhang 23: Inclined surface 24: Dilator side mating surface 29: Locking mechanism 30: Claw 31: Claw receiving part 32: Bottom surface 39: Inclined surface 41: Flange 42: Tapered part 43: Lower outer surface 44: Outer surface 45: First horizontal plate 46: Inclined plate 47: Second horizontal plate 48: Tapered part 49 : Lower outer surface 50 : Outer surface 51 : Inclined plate 52 : Horizontal plate 56 : Tapered section 57 : Lower outer surface 58 : Outer surface 59 : Inclined plate 60 : Horizontal plate

Claims

1. An anal dilator comprising: a cylindrical anal dilator having one end and the other end; an insertion aid having a main body inserted into the anal dilator and housed inside the anal dilator; and a conical tip protruding from the one end of the anal dilator, wherein the one end of the anal dilator has an inclined surface formed thereon, which is continuous with the outer circumferential surface of the tip of the insertion aid.

2. The anal dilator according to claim 1, wherein the insertion aid includes a stepped portion at the boundary between the tip and the main body, having an annular concave auxiliary mating surface formed along the outer circumference of the insertion aid, and the one end of the anal dilator has an annular visor portion formed on the inside that protrudes inward from the anal dilator to form the opening of the anal dilator and has a dilator mating surface on the inside that fits the auxiliary mating surface, and the outer surface of the visor portion is formed as the inclined surface when the dilator mating surface fits the auxiliary mating surface and the visor portion engages with the stepped portion, the anal dilator according to claim 1.

3. The anal dilator according to claim 2, wherein the main body of the insertion aid is tapered in shape such that its outer diameter decreases toward the tip, and the anal dilator has an outer peripheral surface that slopes toward the other end from the base of the visor so as to conform to the tapered shape of the main body of the insertion aid.

4. The anal dilator according to claim 2, wherein the angle of inclination of the visor portion of the anal dilator with respect to the radial direction coincides with the angle of inclination of the tip portion of the insertion aid with respect to the radial direction, and the outer surface of the visor portion forms a flat surface continuous with the outer surface of the tip portion.

5. The auxiliary device side mating surface is continuous from the lower end of the outer peripheral surface of the tip portion, extends in a direction intersecting the radial direction of the main body of the insertion auxiliary device, includes a first surface that is partially exposed from the tip of the visor portion, and is continuous in the order of the outer peripheral surface of the tip portion, the first surface, and the outer surface of the visor portion, as described in claim 2.

6. The anal dilator device according to claim 5, wherein the angle of inclination of the visor portion of the anal dilator with respect to the radial direction is greater than the angle of inclination of the tip portion of the insertion aid with respect to the radial direction.

7. The anal opening device according to claim 5, wherein the mating surface on the auxiliary device side includes a first surface which is perpendicular to the radial direction of the main body of the insertion auxiliary device, and a second surface which is an inclined surface that slopes outward from the vertical surface.

8. The anal dilator includes a tapered portion in which the wall thickness gradually decreases from the other end to the one end, and the outer surface of the tapered portion is continuous with the outer surface of the tip as the inclined surface, according to claim 1.

9. The anal dilator according to any one of claims 1 to 8, wherein a plate-shaped stopper portion is formed at the other end of the anal dilator, extending radially outward from the anal dilator.

10. The anal dilator according to claim 9, wherein the stopper portion integrally includes an inclined plate that is inclined with respect to the radial direction of the anal dilator and a horizontal plate that extends horizontally from the inclined plate.

11. The anal dilator according to claim 9, wherein the stopper portion includes a flange portion formed in an annular shape along the outer circumference of the anal dilator.

12. The anal dilator according to claim 9, further comprising a locking mechanism including a claw portion that protrudes laterally from the main body of the insertion aid, and a claw receiving portion formed on the lower surface of the stopper portion, which locks the claw portion that has been slid into the anal dilator by rotating the insertion aid.

13. The anal dilator according to claim 9, wherein the length from the stopper portion to the one end of the anal dilator is 20 mm or more and 45 mm or less.

14. The anal opening device according to any one of claims 1 to 8, wherein the inclination angle of the tip of the insertion aid with respect to the radial direction is 45° or more and 80° or less.

15. The anal dilator has an outer diameter of 50 mm or less, as described in any one of claims 1 to 8.

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