Ring for preventing organ prolapse

Abstract

A ring 1 for preventing organ prolapse, which is to be inserted into the vagina, has a ring-shaped part 2 comprising a circular cross-sectional skeleton, wherein the ring-shaped part has a ring body 21 made of a soft material and four arc-shaped reinforcing members 3a, 3b, 3c and 3d which are made of a hard or semi-hard material and buried inside the ring body. The ring-shaped part 2 has a first bendable part 51 configured of a first set of arc-shaped reinforcing member-free parts 5a and 5c that are formed of a soft material alone and face to each other, and a second bendable part 52 configured of a second set of arc-shaped reinforcing member-free parts that are formed of a soft material alone and face to each other in the direction orthogonal to the first set of the arc-shaped reinforcing member-free parts 5a and 5c.

Description

Organ prolapse prevention ring

[0001] The present invention relates to a ring for preventing organ prolapse, such as uterine prolapse and cystocele, which is inserted into the vagina.

[0002] Elderly women often suffer from uterine prolapse and cystocele. With aging, the tissues supporting the uterus and the muscles supporting it from below weaken, causing the uterus to drop from its normal position, potentially exposing parts of the uterus and the surrounding bladder wall to the outside of the body. This condition is known as uterine prolapse and cystocele. While vaginal hysterectomy is desirable for treating these conditions, it is technically difficult and rarely performed. Therefore, a conservative treatment for uterine prolapse and cystocele without surgery is desirable. Patent Publication 2002-085436 (Patent Document 1) proposes a vaginal ring for preventing organ prolapse, such as uterine prolapse and cystocele. This uterine prolapse and cystocele prevention ring 1 includes an annular portion 2 and a flexible, curved rod-shaped portion 3 whose leading and trailing ends are connected to the annular portion 2, with an intermediate portion 3a extending upward and toward the center of the annular plane defined by the annular portion 2. The annular portion 2 has an opening 4 formed by a partial defect in the annular portion 2. Also, Japanese Patent Laid-Open Publication No. 2011-167364 (Patent Document 2) proposes a pessary for treating uterine prolapse. The pessary 10 for treating uterine prolapse in Patent Document 2 is characterized by being composed of a cylindrical thin plate member 11 that is immovable in the axial direction but deformable in the radial direction, and the thin plate member 11 is composed of a plurality of metal pieces 13 that are discontinuously arranged in the circumferential direction with gaps 12 of a predetermined length between them, and silicon 14 that is continuously arranged in the circumferential direction so as to coat each metal piece 13, and the silicon 14a arranged in the gaps 12 is deformable in the radial direction.

[0003] JP 2002-085436 JP 2011-167364 (WO2011-102158A, US2012-289771A, EP2537493A)

[0004] In the device disclosed in Patent Document 1, by inserting the ring obliquely into the vagina so that one end is positioned deep inside the uterus and the lower part of the bladder is positioned in the curved rod-shaped portion, the uterus can be pushed up from below by the ring-shaped portion and the bladder can be supported from below by the curved rod-shaped portion, which is effective in alleviating the symptoms of uterine prolapse and cystocele without surgical intervention. However, the device disclosed in Patent Document 1 was not easy to collapse and make small when inserted into the vagina.

[0005] In addition, the device disclosed in Patent Document 2 can be crushed, but when crushed, both ends must be pressed down simultaneously, and the device must be inserted into the vagina in that state, which makes the insertion operation difficult. Also, because it is a thin cylindrical plate and is thin, it is difficult to remove it from the vagina after insertion.

[0006] An object of the present invention is to provide an organ prolapse prevention ring for insertion into the vagina that can be easily inserted into the vagina and can also be easily removed from the vagina.

[0007] The above object is achieved by the following: An organ prolapse prevention ring for insertion into the vagina, the organ prolapse prevention ring comprising a ring-shaped portion formed by a skeleton having a circular or elliptical cross section, the ring-shaped portion comprising a ring main body made of a soft material and four arc-shaped reinforcing bodies made of a hard or semi-hard material embedded in the ring main body, the four arc-shaped reinforcing bodies being spaced apart from one another, the ring-shaped portion comprising a first bendable portion formed by a first set of opposing arc-shaped reinforcing body-free portions and the first set of arc-shaped reinforcing body-free portions formed only of the soft material, and a second bendable portion formed by a second set of opposing arc-shaped reinforcing body-free portions and the second set of arc-shaped reinforcing body-free portions formed only of the soft material and perpendicular to the first set of arc-shaped reinforcing body-free portions.

[0008] FIG. 1 is a front view of an organ prolapse prevention ring according to an embodiment of the present invention. FIG. 2 is a right side view of the organ prolapse prevention ring shown in FIG. 1. FIG. 3 is a perspective view of the organ prolapse prevention ring shown in FIG. 1. FIG. 4 is a cross-sectional view taken along line A-A in FIG. 1. FIG. 5 is a cross-sectional view taken along line B-B in FIG. 1. FIG. 6 is a cross-sectional view taken along line C-C in FIG. 1. FIG. 7 is a cross-sectional view taken along line D-D in FIG. 2. FIG. 8 is a front view of an arc-shaped reinforcing member used in an organ prolapse prevention ring according to an embodiment of the present invention. FIG. 9 is a bottom view of the arc-shaped reinforcing member shown in FIG. 8. FIG. 10 is a front view of an organ prolapse prevention ring according to another embodiment of the present invention. FIG. 11 is a bottom view of the organ prolapse prevention ring shown in FIG. 10. FIG. 12 is a left side view of the organ prolapse prevention ring shown in FIG. 10. FIG. 13 is a perspective view of the organ prolapse prevention ring shown in FIG. 10. FIG. 14 is a cross-sectional view taken along line G-G in FIG. 12. FIG. 15 is a cross-sectional view taken along line E-E in FIG. 10. FIG. 16 is a cross-sectional view taken along line F-F in FIG. 10. FIG. 17 is a front view of another example of an arc-shaped reinforcing body used in an organ prolapse prevention ring according to an embodiment of the present invention. FIG. 18 is a bottom view of the arc-shaped reinforcing body shown in FIG. 17. FIG. 19 is a front view of an organ prolapse prevention ring according to another embodiment of the present invention. FIG. 20 is a right side view of the organ prolapse prevention ring shown in FIG. 19. FIG. 21 is a perspective view of the organ prolapse prevention ring shown in FIG. 19. FIG. 22 is a cross-sectional view taken along line H-H in FIG. 19. FIG. 23 is a cross-sectional view taken along line J-J in FIG. 19. FIG. 24 is a cross-sectional view taken along line K-K in FIG. 19. FIG. 25 is a cross-sectional view taken along line L-L in FIG. 20. FIG. 26 is a front view of an organ prolapse prevention ring according to another embodiment of the present invention. FIG. 27 is a bottom view of the organ prolapse prevention ring shown in FIG. 26. FIG. 28 is a right side view of the organ prolapse prevention ring shown in FIG. 27. FIG. 29 is a cross-sectional view taken along line M-M in FIG. 26. FIG. 30 is a cross-sectional view taken along line N--N in FIG.

[0009] The intravaginal organ prolapse prevention ring of the present invention will be described using the embodiments shown in the drawings. As shown in FIGS. 1 to 9 , the intravaginal organ prolapse prevention ring 1 of the present invention comprises a ring-shaped portion 2 formed of a skeletal portion having a circular or elliptical cross section. The ring-shaped portion 2 comprises a ring main body 21 made of a soft material and four arc-shaped reinforcement members 3a, 3b, 3c, and 3d made of a hard or semi-hard material embedded within the ring main body 21, with the arc-shaped reinforcement members 3a, 3b, 3c, and 3d spaced apart from one another. The ring-shaped portion 2 comprises a first pair of opposing arc-shaped reinforcement-free portions 5a and 5c made entirely of a soft material, a first bendable portion 51 formed by these portions, and a second pair of opposing arc-shaped reinforcement-free portions 5b and 5d made entirely of a soft material, perpendicular to the first pair of arc-shaped reinforcement-free portions 5a and 5c, and a second bendable portion 52 formed by these portions.

[0010] This organ prolapse prevention ring for insertion into the vagina has a first bendable portion and a second bendable portion that can be bent in a direction different from the bending direction of the first bendable portion. Therefore, it can be bent at either of the two bendable portions, making the bending operation easy. Furthermore, in the folded state, both sides protrude, allowing it to be inserted into the vagina from one side, facilitating insertion into the vagina. Furthermore, because the ring-shaped portion is formed by a skeleton with a circular or elliptical cross section, it can be easily removed from the vagina by hooking it with a finger.

[0011] As shown in Figures 1 to 7, the organ prolapse prevention ring 1 for insertion into the vagina of this embodiment comprises a ring-shaped portion 2 formed by a skeletal portion having a circular or elliptical cross section, and the ring-shaped portion 2 comprises a ring main body 21 made of a soft material and four arc-shaped reinforcing bodies 3a, 3b, 3c, and 3d made of a hard material embedded in the ring main body 21.

[0012] The ring-shaped portion 2 is an annular body having a substantially perfect circle shape and has a central opening 4. The ring-shaped portion 2 is not limited to a perfect circle, but may be an ellipse, a modified circle, or the like. The size of the ring-shaped portion 2 varies depending on the patient's physique, but a diameter (outer diameter) of approximately 40 to 120 mm is preferable, with a diameter of 60 to 100 mm being particularly preferable. The inner diameter of the ring-shaped portion 2 (diameter of the central opening 4) is preferably approximately 30 to 110 mm, with a diameter of 35 to 95 mm being particularly preferable.

[0013] 4, 5, and 6, the ring-shaped portion 2 is formed by a skeleton having a circular or elliptical cross section. The diameter of the skeleton forming the ring-shaped portion 2 is preferably 8 to 16 mm, and particularly preferably 10 to 14 mm. The skeleton of the ring-shaped portion 2 does not have to have the same thickness (diameter) throughout. For example, the portion without arc-shaped reinforcement, which will be described later, may have a smaller or larger diameter than the other portions (portions with arc-shaped reinforcement).

[0014] The ring-shaped portion 2 is formed by a ring main body 21 and four arc-shaped reinforcing members 3a, 3b, 3c, and 3d embedded therein. The four arc-shaped reinforcing members 3a, 3b, 3c, and 3d are arranged at equal angular intervals (90 degrees) relative to the center of the ring-shaped portion 2. Adjacent arc-shaped reinforcing members 3a, 3b, 3c, and 3d are spaced apart by a predetermined arc length. It is preferable that the four arc-shaped reinforcing members 3a, 3b, 3c, and 3d are the same.

[0015] Four arc-shaped reinforcement-free portions 5a, 5b, 5c, and 5d are formed in the spaces between the four arc-shaped reinforcements 3a, 3b, 3c, and 3d. The four arc-shaped reinforcement-free portions 5a, 5b, 5c, and 5d are formed only from the soft material that forms the ring main body 21. The ring main body 21 forms the entire outer shape of the ring-shaped portion 2, and the arc-shaped reinforcements 3a, 3b, 3c, and 3d are not exposed on the outer surface of the ring-shaped portion 2.

[0016] The ring-shaped portion 2 includes a first bendable portion 51 formed of a first set of opposing arc-shaped reinforcement-free portions 5a, 5c formed solely of a soft material, and a second bendable portion 52 formed of a second set of arc-shaped reinforcement-free portions 5b, 5d. The second set of arc-shaped reinforcement-free portions 5b, 5d are perpendicular to the first set of arc-shaped reinforcement-free portions 5a, 5c. Therefore, the second bendable portion 52 is bendable in a direction different from the bending direction of the first bendable portion 51. Specifically, the second bendable portion 52 is bendable in a direction substantially perpendicular to the bending direction of the first bendable portion 51. In particular, it is preferable that the second bendable portion 52 be bendable in a direction perpendicular to the bending direction of the first bendable portion 51.

[0017] The central angle of the arc of each of the arc-shaped reinforcing member-free portions 5a, 5b, 5c, and 5d is preferably 24 to 45 degrees, and particularly preferably 25 to 40 degrees. The arc outer edge length of each of the arc-shaped reinforcing member-free portions 5a, 5b, 5c, and 5d is preferably 1 / 15 to 5 / 40 of the outer periphery (circumferential length) of the ring-shaped portion 2, and particularly preferably 1 / 14 to 1 / 9.

[0018] Four arc-shaped reinforcements 3a, 3b, 3c, and 3d made of a hard material are embedded and spaced apart within the ring body 21. The four arc-shaped reinforcements 3a, 3b, 3c, and 3d are arranged at equal angular intervals (90 degrees) relative to the center of the ring-shaped portion 2. The central angle of the arc of each of the arc-shaped reinforcements 3a, 3b, 3c, and 3d is preferably 40 to 72 degrees, and more preferably 45 to 65 degrees. The arc length of each of the arc-shaped reinforcements 3a, 3b, 3c, and 3d is preferably 11 / 100 to 2 / 10 of the circumferential length of the corresponding portion (the circular portion where the four arc-shaped reinforcements are located), and more preferably 5 / 40 to 18 / 100.

[0019] Each of the arc-shaped reinforcing members 3a, 3b, 3c, and 3d has a main body 31 and a recess 32 extending from one surface of the ring-shaped member 2 to the other. In this embodiment, the recess 32 has a main portion 32a that extends a predetermined length in a substantially cylindrical shape (with the same diameter) and a tip portion 32b (conical tip portion) with a tapered diameter. The entire recess 32 is filled with a soft material that forms the ring main body 21.

[0020] As shown in FIG. 6, the arc-shaped reinforcements 3a, 3b, 3c, and 3d have a circular cross section except for the recessed portions 32. However, the cross section may also be elliptical. The diameter of the arc-shaped reinforcements 3a, 3b, 3c, and 3d (excluding the recessed portions) is preferably 1 / 3 to 2 / 3 of the diameter of the skeleton portion forming the ring-shaped portion 2, and more preferably 2 / 5 to 3 / 5. The radius of curvature of the arc-shaped reinforcements 3a, 3b, 3c, and 3d is preferably the same as the radius of curvature of the ring-shaped portion 2 at that portion (the circular portion where the four arc-shaped reinforcements are located), and more preferably the same.

[0021] Furthermore, it is preferable that the four arc-shaped reinforcing members are arranged at approximately equal angular intervals relative to the center of the ring-shaped portion, the central angles of the arcs of the four arc-shaped reinforcing members being 40 to 72 degrees, and the central angles of the arcs of the four arc-shaped reinforcing member-free portions being 24 to 45 degrees. In particular, it is preferable that the four arc-shaped reinforcing members are arranged at approximately equal angular intervals relative to the center of the ring-shaped portion, the central angles of the arcs of the four arc-shaped reinforcing members being 45 to 65 degrees, and the central angles of the arcs of the four arc-shaped reinforcing member-free portions being 25 to 40 degrees.

[0022] As described above, the organ prolapse prevention ring 1 of this embodiment has a first bendable portion 51 formed only from a soft material, and a second bendable portion 52 formed only from a soft material and consisting of a second set of arc-shaped reinforcement-free portions 5b, 5d that face each other and are perpendicular to the first set of arc-shaped reinforcement-free portions 5a, 5c (first bendable portion 51).

[0023] Therefore, by folding the first foldable portion 51 made only of a soft material about the center thereof as the folding axis, i.e., by bringing the second set of arc-shaped reinforcement-free portions 5b, 5d close to or in contact with each other, the organ prolapse prevention ring 1 can be folded in half with both ends (the first set of arc-shaped reinforcement-free portions 5a, 5c) slightly bulging. Similarly, by folding the second foldable portion 52 made only of a soft material about the center thereof as the folding axis, i.e., by bringing the first set of arc-shaped reinforcement-free portions 5a, 5c close to or in contact with each other, the organ prolapse prevention ring 1 can be folded in half with both ends (the second set of arc-shaped reinforcement-free portions 5b, 5d) slightly bulging.

[0024] In this way, the organ prolapse prevention ring 1 can be bent in two directions, so compared to rings having only one bendable portion, the operation of searching for the bendable portion is much easier, or practically unnecessary, and the bending operation is easy. Furthermore, since the first bendable portion 51 and the second bendable portion 52 are formed only from the soft material that forms the ring body 21, bending itself is also easy.

[0025] In the organ prolapse prevention ring 1 of this embodiment, as shown in Figures 6 to 9, the arc-shaped reinforcing bodies 3a, 3b, 3c, and 3d each include a main body 31 and a recess 32 extending from one surface of the ring-shaped portion 2 (main body 31) to the other. As shown in Figures 6 and 7, the recess 32 is filled with a soft material 25 that forms the ring main body 21. This prevents the arc-shaped reinforcing bodies 3a, 3b, 3c, and 3d from moving within the ring-shaped portion 2 when the organ prolapse prevention ring 1 is bent or after insertion into the vagina. The diameter of the recess 32 is preferably 2 / 10 to 6 / 10 of the diameter of the arc-shaped reinforcing bodies 3a, 3b, 3c, and 3d, and more preferably 3 / 10 to 5 / 10. Furthermore, the depth of the recess 32, particularly in this embodiment the depth of the portion 32a extending at the same diameter, is preferably 40 / 100 to 75 / 100 of the diameter of the arc-shaped reinforcing bodies 3a, 3b, 3c, 3d, and more preferably 45 / 100 to 65 / 100.

[0026] Furthermore, in the organ prolapse prevention ring 1 of this embodiment, the arc-shaped reinforcing members 3a, 3b, 3c, and 3d preferably have a plurality of recesses 32. In particular, the arc-shaped reinforcing members 3a, 3b, 3c, and 3d preferably have a recess 32 at each of their opposite ends. In this embodiment, the arc-shaped reinforcing members 3a, 3b, 3c, and 3d each have recesses 32 at three locations: at both ends and in the center. All of these recesses are filled with the soft material 25 that forms the ring body 21.

[0027] A soft elastic material is suitable as the soft material (ring body forming material) used for the ring body 21. Specifically, soft rubber or soft elastomer is used. Examples of soft rubber that are preferred include natural rubber, isoprene rubber, butyl rubber, chloroprene rubber, nitrile-butadiene rubber, styrene-butadiene rubber, and silicone rubber, with vulcanized rubber being particularly preferred. Examples of soft elastomers that are preferred include polyvinyl chloride elastomers, polyolefin elastomers, styrene elastomers, polyester elastomers, polyamide elastomers, polyurethane elastomers, and silicone elastomers. Furthermore, soft thermoplastic elastomers are preferred as the soft elastomers. Examples of thermoplastic elastomers that can be used include polyester elastomers (e.g., polyethylene terephthalate elastomers), nylon elastomers (e.g., polyamide elastomers), urethane elastomers (e.g., polyurethane elastomers), olefin elastomers (e.g., polyethylene elastomers, polypropylene elastomers), and fluororesin elastomers.

[0028] Among the above soft elastic materials, silicone rubber (crosslinked silicone elastomer) is preferred due to its favorable elastic properties and strength. As the silicone rubber, millable silicone rubber is preferred. Millable silicone rubber is a silicone rubber compound whose pre-hardening state resembles unvulcanized compounded rubbers such as natural rubber and ordinary synthetic rubber, and can be plasticized and mixed using a kneading roll mill or an internal mixer. In particular, crosslinked millable silicone rubber is preferred as the soft elastic material.

[0029] Examples of the millable silicone rubber that can be used include KE-541-U, KE-561-U, KE-931-U, KE-941-U, KE-951-U, and KE-961-U manufactured by Shin-Etsu Chemical Co., Ltd. These silicone rubbers may be used alone or in combination of two or more. A crosslinking agent is added to the millable silicone rubber. Suitable crosslinking agents include organic peroxide vulcanizing agents, specifically C-23N (containing paramethylbenzoyl peroxide) manufactured by Shin-Etsu Chemical Co., Ltd., and platinum-based catalysts, specifically C-25A manufactured by Shin-Etsu Chemical Co., Ltd.

[0030] Furthermore, the material (soft elastic material) forming the ring main body preferably has a durometer hardness A at 25°C, as defined in accordance with JIS K6253 "Testing Method for Hardness of Vulcanized and Thermoplastic Rubber," of 15 to 50, particularly 20 to 45, and particularly 25 to 40. With such a material, the second bendable portion 52 can be satisfactorily bent in a direction different from the bending direction of the first bendable portion 51 (specifically, in a direction substantially perpendicular to the bending direction of the first bendable portion 51), the second bendable portion 52 being composed of a first set of opposing arc-shaped reinforcement-free portions 5a, 5c formed only from a soft material, and a second set of opposing arc-shaped reinforcement-free portions 5b, 5d formed only from a soft material and perpendicular to the first set of arc-shaped reinforcement-free portions 5a, 5c. The second bendable portion 52 is preferably bendable in a direction perpendicular to the bending direction of the first bendable portion 51 .

[0031] The soft elastic material preferably has an elongation at break measured in accordance with JIS K6251 of 300 to 900%, and more preferably 400 to 800%, and a tensile strength measured in accordance with JIS K6251 of 5 to 12 MPa, and more preferably 6 to 10 MPa.

[0032] The material (soft elastic material) forming the ring body is preferably transparent or translucent so that the embedded arc-shaped reinforcing members 3 a, 3 b, 3 c, and 3 d can be seen, which makes it easy to confirm the arc-shaped reinforcing member-free areas 5 a, 5 b, 5 c, and 5 d and the positions of the first bendable portion 51 and the second bendable portion 52.

[0033] The arc-shaped reinforcing members 3a, 3b, 3c, and 3d are formed from a hard or semi-hard material. Specifically, hard or semi-hard thermoplastic resins are preferred. Specifically, synthetic resins such as polyamide (nylon 6, nylon 66), polyvinylidene fluoride, polycarbonate, acrylic resins (e.g., polyacrylates, specifically, PMMA (polymethyl methacrylate), polyacrylamide, acrylonitrile-styrene copolymers, acrylonitrile-butadiene-styrene copolymers, etc.), polyesters (e.g., polyethylene terephthalate, polybutylene terephthalate), polyolefins (e.g., polyethylene, polypropylene, ethylene-propylene copolymers), styrene-based resins (e.g., polystyrene, MS resin (methacrylate-styrene copolymers)), MBS resin (methacrylate-butylene-styrene copolymers), polyvinyl chloride (hard vinyl chloride), polysulfone, and polyarylate are preferred, with polyamide (nylon 6, nylon 66) being particularly preferred. Furthermore, it is preferable that the material forming the arc-shaped reinforcing members 3a, 3b, 3c, and 3d be colored (other than white).

[0034] The material for forming the arc-shaped reinforcement preferably has a tensile modulus (ISO 527-1, 23°C) of 1000 to 4000 MPa, and more preferably 1500 to 3000 MPa. The flexural modulus (ISO 178, 23°C) is preferably 1000 to 4000 MPa, and more preferably 1500 to 3000 MPa. The flexural strength (ISO 178, 23°C) is preferably 15 to 45 MPa, and more preferably 20 to 40 MPa.

[0035] Furthermore, when the material forming the arc-shaped reinforcement is a thermoplastic resin and the material used to form the ring body is a cross-linked silicone rubber, it is preferable that the melting point of the thermoplastic resin be higher than the heating temperature for cross-linking (cross-linking temperature). In particular, when the material used to form the ring body is a cross-linked silicone rubber, it is preferable that the melting point of the material forming the arc-shaped reinforcement be 15°C or more higher than the heating temperature for cross-linking. Although this will vary depending on the cross-linking temperature of the soft elastic material used, a thermoplastic resin with a melting point of 240 to 280°C, and particularly 245 to 275°C, is preferable for the thermoplastic resin used to form the arc-shaped reinforcement.

[0036] Furthermore, it is preferable that the materials forming the arc-shaped reinforcement members and the ring body are incompatible. If they are incompatible, they will not melt at their contact surface and will not bond at their interface. Therefore, when the organ prolapse prevention ring 1 is deformed, the arc-shaped reinforcement members can slide slightly within the ring body, improving the organ prolapse prevention ring's deformation. For example, the above-described state can be achieved by selecting polyamide (6 nylon, 66 nylon) as the material forming the arc-shaped reinforcement members and silicone rubber (crosslinked silicone elastomer) as the material forming the ring body. Furthermore, the thickness of the soft material of the ring body 21 that encases the outer surfaces of the arc-shaped reinforcement members 3a, 3b, 3c, and 3d is preferably 1.5 mm or more, particularly 2 mm or more, and even more preferably 2.5 mm or more. This ensures that the organ prolapse prevention ring 1 has sufficient surface elasticity at the locations where the arc-shaped reinforcement members 3a, 3b, 3c, and 3d are located.

[0037] The organ prolapse prevention ring for intravaginal insertion of the present invention may also be an organ prolapse prevention ring 1a for intravaginal insertion of the type shown in Figures 10 to 18. The organ prolapse prevention ring 1a of this embodiment differs mainly from the organ prolapse prevention ring 1 for intravaginal insertion of the above-described embodiment in that the organ prolapse prevention ring 1a has an elastic rod-like portion (string-like portion) 6 with one end 6a connected to the ring-shaped portion 2a. The arc-shaped reinforcing members 13a, 13b, 13c, and 13d used in this organ prolapse prevention ring 1a are substantially the same as the arc-shaped reinforcing members 3a, 3b, 3c, and 3d described above, except for the shape of the recess 72, which is slightly different.

[0038] The organ prolapse prevention ring 1a of this embodiment includes an elastic rod-shaped portion 6, one end 6a of which is connected to the ring main body 21a and the other end 6b is a free end, and which has a total length longer than the inner diameter of the ring-shaped portion 2a. In this embodiment, the elastic rod-shaped portion 6 has one end 6a connected to the inner surface of the arc-shaped reinforcement-free portion 5a. As in this embodiment, the elastic rod-shaped portion 6 is formed integrally with the ring-shaped portion 2a from the soft material that forms the ring main body 21a.

[0039] Furthermore, the elastic rod-shaped portion 6 in the organ prolapse prevention ring 1a of this embodiment has one end 6a located on the inner surface of the arc-shaped reinforcement-free portion 5a, and is provided with a first portion 6c extending from the one end 6a toward the center of the ring-shaped portion 2a, a second portion 6d curving from the end of the first portion 6c and extending above the surface of the ring-shaped portion 2a, and a third portion 6e curving from the end of the second portion 6d and extending above the ring-shaped portion 2a approximately parallel to the ring-shaped portion 2a, and the end 6b of the third portion 6e is a free end.

[0040] Specifically, as shown in Figures 10 to 16, the elastic rod-shaped portion 6 is an elastic string-like member with a substantially circular cross section. The cross-sectional diameter of the elastic rod-shaped portion 6 is preferably 3 to 6 mm, and particularly preferably 3.5 to 5 mm. One end 6a of the elastic rod-shaped portion 6 is connected to the inner surface of the arc-shaped reinforcement-free portion 5a. A first portion 6c extends from the one end 6a toward the center of the ring-shaped portion 2a for a predetermined length, approximately 5 to 15 mm. A second portion 6d is curved from the end of the first portion 6c and extends obliquely above the surface and toward the center of the ring-shaped portion 2a. The end of the second portion 6d is located closer to the arc-shaped reinforcement-free portion 5c, which faces the arc-shaped reinforcement-free portion 5a, than the center of the ring-shaped portion 2a. Therefore, the end side of the second portion 6d extends obliquely above the center of the ring-shaped portion 2a.

[0041] The elastic rod-shaped portion 6 also includes a third portion 6e extending from the end of the second portion 6d above the ring-shaped portion 2a and generally parallel to the ring-shaped portion 2a. In this embodiment, the third portion 6e extends beyond the upper portion of the arc-shaped reinforcement-free portion 5c of the ring-shaped portion 2a. Therefore, the third portion 6e extends beyond the outer edge of the ring-shaped portion 2a by a predetermined length, approximately 5 to 20 mm. The end 6b of the third portion 6e is a free end, and is hemispherical, with no corners. The provision of this elastic rod-shaped portion 6 makes it easy to confirm that the organ prolapse prevention ring 1a has been inserted into the vagina, and also makes it easy to remove the organ prolapse prevention ring 1a from the vagina.

[0042] 17 and 18, the arc-shaped reinforcing members 13a, 13b, 13c, and 13d used in this organ prolapse prevention ring 1a have the same basic configuration as the above-mentioned arc-shaped reinforcing members 3a, 3b, 3c, and 3d, but are slightly different in the shape of the recesses 72 facing the main body 71. The entire recesses 72 in these arc-shaped reinforcing members 13a, 13b, 13c, and 13d are formed by main portions 72a that extend with approximately the same outer diameter, and the bottoms 72b of the recesses 72 are flat.

[0043] 14 and 16, the recess 72 is filled with a soft material 25 that forms the ring body. The diameter of the recess 72 is preferably 2 / 10 to 6 / 10 of the diameter of the arc-shaped reinforcing members 13a, 13b, 13c, and 13d, and more preferably 3 / 10 to 5 / 10. The entire recess 72 extends with the same diameter. The depth of the recess 72 is preferably 40 / 100 to 75 / 100 of the diameter of the arc-shaped reinforcing members 13a, 13b, 13c, and 13d, and more preferably 45 / 100 to 70 / 100.

[0044] The organ prolapse prevention ring for intravaginal insertion of the present invention may also be an organ prolapse prevention ring 1b for intravaginal insertion of the type shown in Figures 19 to 25. The main difference between the organ prolapse prevention ring 1b of this embodiment and the organ prolapse prevention ring 1 for intravaginal insertion of the above-described embodiment is that the organ prolapse prevention ring 1b has elastic rod-like portions (string-like portions) 8 connected at one end 41 and the other end 42 to the ring-shaped portion 2b.

[0045] The organ prolapse prevention ring 1b of this embodiment includes an elastic rod-shaped portion (string-shaped portion) 8, one end 41 and the other end 42 of which extend through the center of the ring-shaped portion 2b. Specifically, one end 41 of the elastic rod-shaped portion 8 is connected to the inner surface of the arc-shaped reinforcement-free portion 5a. The elastic rod-shaped portion 8 extends linearly and passes through the center of the ring-shaped portion 2b, and the other end is connected to the inner surface of the arc-shaped reinforcement-free portion 5c facing the arc-shaped reinforcement-free portion 5a. The elastic rod-shaped portion 8 is formed integrally with the ring-shaped portion 2b from the soft material that forms the ring main body 21b. As shown in Figures 23 and 24, the elastic rod-shaped portion 8 is an elastic string-shaped member with a substantially circular cross section. The cross-sectional diameter of the elastic rod-shaped portion 8 is preferably 3 to 6 mm, and more preferably 3.5 to 5 mm.

[0046] The organ prolapse prevention ring for intravaginal insertion of the present invention comprises a ring-shaped portion formed by a skeleton having a circular or elliptical cross section. The ring-shaped portion comprises a ring main body made of a soft material and four arc-shaped reinforcing members made of a hard or semi-hard material embedded in the ring main body. The four arc-shaped reinforcing members are spaced apart from one another. The ring-shaped portion comprises a first set of opposing arc-shaped reinforcing member-free sections formed solely of the soft material and a first foldable section formed thereby, and a second set of opposing arc-shaped reinforcing member-free sections formed solely of the soft material and perpendicular to the first set of arc-shaped reinforcing member-free sections and a second foldable section formed thereby.

[0047] In particular, the organ prolapse prevention ring for intravaginal insertion of the present invention includes a first bendable portion and a second bendable portion that can be bent in a direction different from the bending direction of the first bendable portion, specifically, in a direction substantially perpendicular to the bending direction of the first bendable portion. Therefore, since it can be bent at either of the two bendable portions, it is easy to select the bending position and perform the bending operation. Furthermore, in the folded state, both sides protrude, allowing it to be inserted into the vagina from one side, facilitating insertion into the vagina. Furthermore, since the ring-shaped portion is formed by a skeleton with a circular or elliptical cross section, it can be easily removed from the vagina by hooking it with a finger.

[0048] The organ prolapse prevention ring for intravaginal insertion of the present invention may also be an organ prolapse prevention ring 1c for intravaginal insertion of the type shown in Figures 26 to 30. The main difference between the organ prolapse prevention ring 1c of this embodiment and the organ prolapse prevention ring 1 for intravaginal insertion of the above-described embodiment is that the organ prolapse prevention ring 1c has elastic rod-like portions (string-like portions) 8a with one end 41 and the other end 42 connected to the ring-shaped portion 2b.

[0049] The organ prolapse prevention ring 1c of this embodiment includes an elastic rod-shaped portion (string-shaped portion) 8a, one end 41 and the other end 42 of which are connected to the ring-shaped portion 2b. Specifically, one end 41 of the elastic rod-shaped portion 8a is connected to the inner surface of the arc-shaped reinforcement-free portion 5a. Similarly, the other end 42 of the elastic rod-shaped portion 8a is connected to the inner surface of the arc-shaped reinforcement-free portion 5c facing the arc-shaped reinforcement-free portion 5a. The elastic rod-shaped portion 8a also includes a curved portion 43 in its center.

[0050] The curved portion 43 preferably has an apex at the upper center of the ring-shaped portion 2b, and is particularly preferably curved in a substantially semicircular shape. The apex of the curved portion 43 is preferably located at the upper center of the ring-shaped portion 2b. The curved portion 43 may be bent at the apex, extend linearly for a predetermined length, or have a trapezoidal shape as a whole. In the organ prolapse prevention ring 1c of this embodiment, as shown in Figures 27, 28, and 29, the center of the curved portion 43 protrudes above the circular surface formed by the upper surface of the ring-shaped portion 2b (the surface from which the curved portion extends).

[0051] 29, in the organ prolapse prevention ring 1c of this embodiment, the elastic rod-shaped portion 8a includes a short straight portion 41a extending from one end 41 toward the inside (center) of the ring-shaped portion 2b, and a one-end curved portion 43a extending from the short one-end straight portion 41a in a direction perpendicular to the straight portion 41a. The elastic rod-shaped portion 8a also includes a short other-end straight portion 42a extending from the other end 42 toward the inside (center) of the ring-shaped portion 2b, and a other-end curved portion 43b extending from the short other-end straight portion 42a in a direction perpendicular to the straight portion 42a (the same direction as the one-end curved portion 43a). The curved portion 43 connects the one-end curved portion 43a and the other-end curved portion 43b. The center of the curved portion 43 protrudes above the circular surface formed by the upper surface (the surface from which the curved portion extends) of the ring-shaped portion 2 b. In this embodiment, the curved portion 43 has a gap 44 on the inside (the center side of the ring-shaped portion 2 b) that is located at the upper center of the ring-shaped portion 2 b.

[0052] The elastic rod-shaped portion 8a is formed integrally with the ring-shaped portion 2b from the soft material that forms the ring main body 21b. As shown in Figure 28, the elastic rod-shaped portion 8a is an elastic string-like member with a substantially circular cross section. The cross-sectional diameter of the elastic rod-shaped portion 8a is preferably 3 to 6 mm, and particularly preferably 3.5 to 5 mm. The organ prolapse prevention ring 1c for intravaginal insertion of this embodiment is equipped with the elastic rod-shaped portion 8a having a curved portion 43 in the center, so that it can be easily removed from the vagina by hooking a finger on this curved portion.

[0053] The organ prolapse prevention ring for intravaginal insertion of the present invention comprises a ring-shaped portion formed by a skeleton having a circular or elliptical cross section. The ring-shaped portion comprises a ring main body made of a soft material and four arc-shaped reinforcing members made of a hard or semi-hard material embedded in the ring main body. The four arc-shaped reinforcing members are spaced apart from one another. The ring-shaped portion comprises a first set of opposing arc-shaped reinforcing member-free sections formed solely of the soft material and a first foldable section formed thereby, and a second set of opposing arc-shaped reinforcing member-free sections formed solely of the soft material and perpendicular to the first set of arc-shaped reinforcing member-free sections and a second foldable section formed thereby.

[0054] In particular, the device has a first bendable portion and a second bendable portion that can be bent in a direction different from the bending direction of the first bendable portion. Therefore, the device can be bent at either of the two bendable portions, making the folding operation easy. Furthermore, in the folded state, both sides protrude, allowing insertion into the vagina from one side, facilitating insertion into the vagina. Furthermore, the ring-shaped portion is formed by a skeleton with a circular or elliptical cross section, allowing easy removal from the vagina by hooking it with a finger.

[0055] The organ prolapse prevention ring of the present invention is as follows: (1) An organ prolapse prevention ring for insertion into the vagina, the organ prolapse prevention ring comprising a ring-shaped portion formed by a skeleton having a circular or elliptical cross section, the ring-shaped portion comprising a ring main body made of a soft material and four arc-shaped reinforcing bodies made of a hard or semi-hard material embedded in the ring main body, the four arc-shaped reinforcing bodies being spaced apart from one another, the ring-shaped portion comprising a first bendable portion formed by a first set of opposing arc-shaped reinforcing body-free portions and the first set of arc-shaped reinforcing body-free portions formed only of the soft material, and a second bendable portion formed by a second set of opposing arc-shaped reinforcing body-free portions and the second set of arc-shaped reinforcing body-free portions formed only of the soft material and perpendicular to the first set of arc-shaped reinforcing body-free portions.

[0056] This organ prolapse prevention ring for insertion into the vagina has a first bendable portion and a second bendable portion that can be bent in a direction different from the bending direction of the first bendable portion. Therefore, it can be bent at either of the two bendable portions, making the bending operation easy. Furthermore, in the folded state, both sides protrude, allowing it to be inserted into the vagina from one side, facilitating insertion into the vagina. Furthermore, because the ring-shaped portion is formed by a skeleton with a circular or elliptical cross section, it can be easily removed from the vagina by hooking it with a finger.

[0057] The above embodiments may also be as follows. (2) The organ prolapse prevention ring according to (1) above, wherein the arc-shaped reinforcement body has a recess extending from one surface side of the ring-shaped portion to the other surface side, and the recess is filled with the soft material forming the ring main body. (3) The organ prolapse prevention ring according to (1) or (2) above, wherein the arc-shaped reinforcement bodies are arranged at approximately equal angular intervals with respect to the center of the ring-shaped portion, the central angle of the arc of each arc-shaped reinforcement body is 40 to 72 degrees, and the central angle of the arc of the four arc-shaped reinforcement-free portions is 24 to 45 degrees. (4) The organ prolapse prevention ring according to (1) or (2) above, wherein the arc-shaped reinforcement bodies are arranged at approximately equal angular intervals with respect to the center of the ring-shaped portion, the central angle of the arc of each arc-shaped reinforcement body is 45 to 65 degrees, and the central angle of the arc of the four arc-shaped reinforcement-free portions is 25 to 40 degrees. (5) The organ prolapse prevention ring according to any one of (2) to (4) above, wherein the arc-shaped reinforcement members have the recesses at both ends. (6) The organ prolapse prevention ring according to any one of (1) to (5) above, wherein the soft material forming the four arc-shaped reinforcement member-free portions is an elastic material having a durometer hardness A of 15 to 50. (7) The organ prolapse prevention ring according to any one of (1) to (6) above, wherein the soft material forming the ring main body portion is soft rubber or soft elastomer. (8) The organ prolapse prevention ring according to any one of (1) to (7) above, wherein the organ prolapse prevention ring has one end connected to the ring main body portion and the other end as a free end, and comprises an elastic rod-shaped portion having a total length longer than the inner diameter of the ring-shaped portion. (9) The organ prolapse prevention ring according to (8), wherein the elastic rod-shaped portion has one end connected to the arc-shaped reinforcement member-free portion. (10) The organ prolapse prevention ring according to (9) above, wherein the elastic rod-shaped portion is formed integrally with the ring-shaped portion by the soft material forming the ring main body.(11) The organ prolapse prevention ring according to any one of (8) to (10) above, wherein the elastic rod-shaped portion has one end located on the inner surface of the arc-shaped reinforcement-free portion and comprises a first portion extending from the one end toward the center of the ring-shaped portion, a second portion curving from the end of the first portion and extending above the surface of the ring-shaped portion, and a third portion curving from the end of the second portion and extending above the ring-shaped portion approximately parallel to the ring-shaped portion, the end of the third portion being the free end. (12) The organ prolapse prevention ring according to any one of (1) to (7) above, wherein the organ prolapse prevention ring comprises an elastic rod-shaped portion, one end and the other end of which are connected to the ring main body. (13) The organ prolapse prevention ring according to (12) above, wherein the one end and the other end of the elastic rod-shaped portion are connected to the inner surface of the ring main body. (14) The organ prolapse prevention ring according to (12) or (13) above, wherein one end of the elastic rod-shaped portion is connected to the inner surface of the arc-shaped reinforcement-free portion and the other end of the elastic rod-shaped portion is connected to the inner surface of the arc-shaped reinforcement-free portion facing the arc-shaped reinforcement-free portion to which the one end is connected. (15) The organ prolapse prevention ring according to any of (12) to (14) above, wherein the elastic rod-shaped portion extends linearly from the one end to the other end. (16) The organ prolapse prevention ring according to any of (12) to (14) above, wherein the elastic rod-shaped portion has a curved portion with an apex at the upper center of the ring-shaped portion.

Claims

1. A ring for preventing organ prolapse when inserted into the vagina, The aforementioned organ prolapse prevention ring comprises a ring-shaped portion formed by a skeletal part with a circular or elliptical cross-section, The ring-shaped portion comprises a ring body made of a soft material and four arc-shaped reinforcing bodies made of a hard or semi-hard material embedded within the ring body, wherein the four arc-shaped reinforcing bodies are spaced apart from each other, and the ring-shaped portion comprises a first bendable portion composed of a first pair of opposing arc-shaped reinforcing body-free portions formed solely of the soft material and the first pair of arc-shaped reinforcing body-free portions and a second bendable portion composed of a second pair of opposing arc-shaped reinforcing body-free portions formed solely of the soft material and perpendicular to the first pair of arc-shaped reinforcing body-free portions and the second pair of arc-shaped reinforcing body-free portions.

2. The organ prolapse prevention ring according to claim 1, wherein the arc-shaped reinforcing member has a recess extending from one side of the ring-shaped portion toward the other side, and the recess is filled with the soft material that forms the ring body.

3. The organ prolapse prevention ring according to claim 1 or 2, wherein each of the arc-shaped reinforcing members is arranged at approximately equal angular intervals with respect to the center of the ring-shaped portion, the central angle of the arc of each arc-shaped reinforcing member is 40 to 72 degrees, and the central angle of the arc of the four portions where the arc-shaped reinforcing members are absent is 24 to 45 degrees.

4. The organ prolapse prevention ring according to claim 1 or 2, wherein each of the arc-shaped reinforcing members is arranged at approximately equal angular intervals with respect to the center of the ring-shaped portion, the central angle of the arc of each arc-shaped reinforcing member is 45 to 65 degrees, and the central angle of the arc of the four portions where the arc-shaped reinforcing members are absent is 25 to 40 degrees.

5. The organ prolapse prevention ring according to claim 2, wherein the arc-shaped reinforcing body is provided with the recesses at both ends.

6. The organ prolapse prevention ring according to claim 1 or 2, wherein the soft material forming the four arc-shaped reinforcing body non-existent portions is an elastic material and has a durometer hardness A of 15 to 50.

7. The organ prolapse prevention ring according to claim 1 or 2, wherein the soft material forming the ring body is soft rubber or soft elastomer.

8. The organ prolapse prevention ring according to claim 1 or 2, wherein one end of the organ prolapse prevention ring is connected to the ring body and the other end is a free end, and the ring has an elastic rod-shaped portion having a total length longer than the inner diameter of the ring-shaped portion.

9. The organ prolapse prevention ring according to claim 8, wherein one end of the elastic rod-shaped portion is connected to the portion where the arc-shaped reinforcing body is not present.

10. The organ prolapse prevention ring according to claim 8, wherein the elastic rod-shaped portion is integrally formed with the ring-shaped portion by the soft material that forms the ring body portion.

11. The organ prolapse prevention ring according to claim 8, wherein the elastic rod-shaped portion has one end located on the inner surface of the portion where the arc-shaped reinforcing body is absent, and comprises a first portion extending from the one end toward the center of the ring-shaped portion, a second portion curving from the end of the first portion and extending above the surface of the ring-shaped portion, and a third portion curving from the end of the second portion and extending above the ring-shaped portion substantially parallel to the ring-shaped portion, with the end of the third portion being the free end.

12. The organ prolapse prevention ring according to claim 1 or 2, wherein the organ prolapse prevention ring comprises an elastic rod-shaped portion having one end and the other end connected to the ring body.

13. The organ prolapse prevention ring according to claim 12, wherein one end and the other end of the elastic rod-shaped portion are connected to the inner surface of the ring body portion.

14. The organ prolapse prevention ring according to claim 12, wherein one end of the elastic rod-shaped portion is connected to the inner surface of the portion where the arc-shaped reinforcing body is absent, and the other end of the elastic rod-shaped portion is connected to the inner surface of the portion where the arc-shaped reinforcing body is absent that faces the portion where the arc-shaped reinforcing body is absent to which the one end is connected.

15. The organ prolapse prevention ring according to claim 12, wherein the elastic rod-shaped portion extends linearly from one end to the other end.

16. The organ prolapse prevention ring according to claim 12, wherein the elastic rod-shaped portion comprises a curved portion having a vertex at the upper central part of the ring-shaped portion.

17. A ring for preventing organ prolapse for intravaginal insertion, The aforementioned organ prolapse prevention ring comprises a ring-shaped portion formed by a skeletal part with a circular or elliptical cross-section, The ring-shaped portion comprises a ring body made of a soft material and four arc-shaped reinforcing bodies made of a hard or semi-hard material embedded within the ring body, the four arc-shaped reinforcing bodies being spaced apart from each other, and the ring-shaped portion comprises a first bendable portion composed of a first pair of opposing arc-shaped reinforcing body-free portions formed solely of the soft material and the first pair of arc-shaped reinforcing body-free portions being opposed to each other and a second bendable portion composed solely of the soft material and composed of a second pair of opposing arc-shaped reinforcing body-free portions perpendicular to the first pair of arc-shaped reinforcing body-free portions and the second pair of arc-shaped reinforcing body-free portions being opposed to each other. Each of the aforementioned arc-shaped reinforcing members is arranged at equal angular intervals with respect to the center of the ring-shaped portion, and the central angle of the arc of each of the arc-shaped reinforcing members is between 40 and 72 degrees. The organ prolapse prevention ring has an elastic rod-shaped portion at one end and the other end connected to the ring body, An organ prolapse prevention ring characterized in that one end of the elastic rod-shaped portion is connected to the inner surface of the portion where the arc-shaped reinforcing body is absent, and the other end of the elastic rod-shaped portion is connected to the inner surface of the portion where the arc-shaped reinforcing body is absent that faces the portion where the arc-shaped reinforcing body is absent to which the one end is connected.

18. The organ prolapse prevention ring according to claim 17, wherein each of the arc-shaped reinforcing members is arranged at equal angular intervals with respect to the center of the ring-shaped portion, and the central angle of the arc of each of the arc-shaped reinforcing members is 45 to 65 degrees.

19. The organ prolapse prevention ring according to claim 17, wherein each of the arc-shaped reinforcing members is arranged at equal angular intervals with respect to the center of the ring-shaped portion, and the central angles of the arcs in the four portions where the arc-shaped reinforcing members are absent are 24 to 45 degrees.