WO2015041353A1

WO2015041353A1 - Ring pessary for treatment of uterine prolapse or hysteroptosis

Info

Publication number: WO2015041353A1
Application number: PCT/JP2014/074962
Authority: WO
Inventors: 潤子八木
Original assignee: 潤子八木; 八木太郎; 八木茉莉
Priority date: 2013-09-20
Filing date: 2014-09-19
Publication date: 2015-03-26
Also published as: JPWO2015041353A1

Abstract

Provided is a ring pessary (1) for the treatment of uterine prolapse or hysteroptosis, the ring pessary (1) being used to control uterine prolapse or hysteroptosis by supporting the lower uterine segment. The ring pessary (1) is characterized in that: the ring pessary (1) includes a resin ring (10); the resin ring (10) has an outer diameter (OD) of 5-9 cm, and the load necessary to compress the outer diameter to 2 cm is 2-10 N; and the external dimension of the resin ring 30 seconds after the load is removed is at least 70% of said outer diameter of the resin ring.

Description

Ring pessary for uterine prolapse or uterine droop treatment

The present invention relates to a uterine prolapse or uterine drop treatment ring used for the treatment of uterine prolapse or uterine ptosis, and more particularly to a uterine prolapse or uterine drop treatment ring that can be easily attached or detached by a patient.

As a method for treating uterine prolapse or uterine ptosis, a method using a “ring pessary” that is a ring-shaped therapeutic instrument is known (for example, Patent Document 1). In treatment, a ring pessary is installed at the upper end of the vagina to support the lower uterus with the ring pessary. Thereby, treatment and prevention of uterine prolapse or uterine drooping can be performed.
The ring pessary is mainly installed transvaginally in the upper part of the vagina in a medical institution, then periodically removed from the medical institution every several months, and installed again after washing.

JP 2011-167364 A

In recent years, it has been reported that vaginitis occurs due to treatment methods that leave ring pessaries in place for several months. Therefore, in order to prevent vaginitis, it has been proposed that the patient himself attach and detach the ring pessary every day at home. When a patient wakes up in the morning, he / she inserts a ring pessary by himself / herself and takes out the ring pessary before going to bed at night, thereby making vaginitis less likely.

However, conventionally, it has been considered that the use of a ring pessary that is relatively hard and difficult to deform can effectively treat uterine prolapse or uterus. Such a hard and difficult to deform ring pessary has not been detachable by the patient himself. In addition, the main patients with uterine prolapse or uterine ptosis are middle-aged and older women, but there are also those who have been born or young. In the case of a naive woman, it was extremely difficult to insert the ring pessary that is hard and difficult to deform vaginally, and the patient was forced to withstand severe pain.

Therefore, an object of the present invention is to provide a ring pessary for treating uterine prolapse or uterus that is easy to attach and detach by the patient himself, has little pain at the time of attachment and detachment, and hardly damages the vagina.

The ring pessary of the present invention is
A ring pessary for treating uterine prolapse or uterine droop for supporting the lower uterus and suppressing uterine prolapse or uterine drooping,
The ring pessary includes a resin ring,
The outer diameter of the resin ring is 5 to 9 cm, and the load required to compress the outer diameter to 2 cm is 2 to 10 N.
The outer dimension of the resin ring 30 seconds after unloading is 70% or more of the outer diameter of the resin ring.

In the ring pessary of the present invention, the resin ring can be compressed and deformed to an outer dimension of 2 cm only by applying a load of 2 to 10 N or less, so that the patient can attach and detach the ring pessary at home. Further, since the resin ring is inserted after being sufficiently deformed, the patient is less likely to feel strong pain when attaching / detaching the ring pessary, and the vagina is hardly damaged.
Also, the resin ring used in the ring pessary of the present invention returns to 70% or more of the original outer diameter after 30 seconds after removing the load for compressive deformation. There is no loss of functionality.

1A and 1B show a ring pessary according to Embodiment 1, in which FIG. 1A is a perspective view and FIG. 1B is a top view. Fig.2 (a) is a schematic diagram which shows the state which installed the ring pessary which concerns on Embodiment 1 in the vagina upper end, FIG.2 (b) is the elements on larger scale of Fig.2 (a). FIG. 3 is a top view of a resin ring used in the ring pessary according to the first embodiment. FIGS. 4A and 4B are cross-sectional views of ring pessaries provided with resin rings having various cross-sectional shapes. FIGS. 5A and 5B are cross-sectional views of a ring pessary provided with resin rings having various cross-sectional shapes. 6 (a) to 6 (b) are cross-sectional views of a ring pessary provided with a flexible film having various shapes. FIG. 7A is a perspective view of a ring pessary provided with a medicine holding portion, and FIG. 7B is a cross-sectional view of the ring pessary along the line BB in FIG. 7A. FIGS. 8A to 8C are cross-sectional views of ring pessaries provided with various forms of drug holding portions. FIG. 9 is a top view of a ring pessary provided with a string. FIG. 10 shows a ring pessary provided with a string attaching portion, FIG. 10 (a) is a perspective view, and FIG. 10 (b) is a top view. Fig.11 (a) is a front view of the string for attaching to a ring pessary, and FIG.11 (b) is sectional drawing for demonstrating the attachment method of a string. 12 (a) to 12 (b) are perspective views of a ring pessary provided with various types of string attaching portions. 13A and 13B show a ring pessary provided with a protrusion, where FIG. 13A is a perspective view and FIG. 13B is a cross-sectional view. FIGS. 14A and 14B show another ring pessary provided with a protrusion, in which FIG. 14A is a perspective view and FIG. 14B is a cross-sectional view. 15A and 15B show still another ring pessary provided with a protrusion. FIG. 15A is a perspective view, and FIG. 15B is a cross-sectional view. 16A and 16B show still another ring pessary provided with a protrusion, wherein FIG. 16A is a perspective view and FIG. 16B is a cross-sectional view. FIG. 17 is a hysteresis-loss curve of a resin ring used in the ring pessary of the present invention. FIG. 18 is a hysteresis-loss curve of the resin ring of the comparative example.

Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. In the following description, terms indicating specific directions and positions (for example, “up”, “down”, “right”, “left” and other terms including those terms) are used as necessary. . The use of these terms is to facilitate understanding of the invention with reference to the drawings, and the technical scope of the present invention is not limited by the meaning of these terms. Moreover, the part of the same code | symbol which appears in several drawing shows the same part or member.

<Embodiment 1>
As shown in FIG. 1, the ring pessary 1 according to the present embodiment includes a resin ring 10. The resin ring 10 shown in FIG. 1 has a shape in which a wide band-like body is used as a ring. The dimension of the resin ring 10 is preferably determined based on the dimension of the body cavity (the dimension of the upper end of the vagina) in the horizontal direction when the resin ring 10 is upright (for example, the dimension of the upper end of the vagina). The width W (dimension in the z direction) = 0.5 cm to 1 cm and the thickness T (dimension in the diameter direction) = 0.2 cm to 0.6 cm.

As shown in FIG. 2, the ring pessary 1 is placed at the upper end of the vagina 91 when the ring pessary 1 is used to treat uterine prolapse or uterine droop. At this time, the resin ring 10 (particularly the outer surface 13) of the ring pessary 1 is held at the upper end of the vagina 91 by the surrounding soft tissue (vagina wall 95), and the upper surface 11 of the resin ring 10 is the uppermost end of the vagina 91. It comes into contact with the vaginal lid 93 (upward concave inner wall surrounding the uterine vagina part 94). Thereby, since the ring pessary 1 can support the lower part of the uterus 90 from the lower side, it can prevent or treat uterine prolapse or uterine droop. At this time, since the uterine vagina part 94 is fitted inside the resin ring 10, the resin ring 10 is more stably held in the vagina. The resin ring 10 can also stimulate an organ (for example, the bladder 98 and the rectum 99) located around the upper end of the vagina 91. Therefore, the ring pessary 1 can also have an effect of suppressing bladder prolapse, frequent urination, constipation, and the like along with treatment of uterine prolapse or uterine droop. In addition, by using pessaries early (for example, after birth, at an early stage of uterine drooping), it is possible to prevent uterine drooping and uterine prolapse and to promote recovery of wrinkles.

The ring pessary 1 is inserted into the upper end of the vagina 91 transvaginally from the direction of arrow X (FIG. 2A). At this time, as shown in FIG. 3, the resin ring 10 is compressed from the both sides in the diametrical direction with loads F ₁ and F ₂ so as to have an elongated shape like the resin ring 10 ′. It becomes very easy to insert. Since the diameter of the vagina of an adult woman is about 2 cm to 3 cm, the resistance when the resin ring 10 is inserted into the vagina 91 can be significantly reduced by deforming the resin ring 10 to 2 cm. That is, if the outer diameter OD = 5 to 9 cm of the resin ring 10 is deformed to 2 cm and then inserted into the vagina 91, the ring pessary 1 can be inserted very easily. Therefore, the ring pessary 1 can be easily inserted even by a young mother.

The load necessary for compressing the outer diameter OD = 5-9 cm of the resin ring 10 to the outer dimension DD = 2 cm (this is referred to as “compressive load” in this specification) can be 2-10 N. A compressive load of 2 to 10 N is a small load that can be sufficiently applied by a female fingertip. Therefore, the female patient can deform the resin ring 10 with the fingertip. That is, when inserting the ring pessary 1, the patient can insert the resin ring 10 into the vagina after compressing the resin ring 10 to 2 cm with the patient's own fingertip. Further, when the ring pessary 1 is taken out from the vagina, the patient himself / herself can insert the fingertip into the vagina to sandwich the resin ring 10, compress the outer dimension DD of the resin ring 10 to 2 cm, and then pull it out. Thus, since the resin ring 10 can be sufficiently elongated when the ring pessary 1 is inserted and removed, the patient can insert and remove the ring pessary 1 without causing severe pain.

In the present specification, “the outer diameter OD of the resin ring 10” means “the diameter of the outer surface 13 of the resin ring 10” when the resin ring 10 (circular shape before deformation) is viewed from above. In other words, when the resin ring 10 before deformation is viewed from above, the second point on the outer surface 13 located on the opposite side through the center of the circle from the first point on the outer surface 13 of the resin ring 10. It is the distance to.

In the present specification, “the outer dimension DD of the resin ring 10” refers to the minimum outer dimension of the resin ring 10 after deformation or unloading. When the deformed resin ring 10 is viewed from above, the distance between the two points (between the first point and the second point) at which the outer diameter OD is measured (= the outer dimension in a broad sense) has various values. Can take. The smallest value among them was defined as “outside dimension DD” in the present application.
In addition, when the resin ring 10 is completely unrestored when the resin ring 10 is unloaded after being deformed (when the resin ring 10 returns to the same circle as the original resin ring 10), the resin ring 10 after being deformed and restored is restored. The “outer dimension DD” matches the “outer diameter OD” of the resin ring 10 before deformation.

Conventionally, it has been considered that it is necessary to use a hard ring pessary to firmly support the lower side of the uterus in the treatment of uterine prolapse or uterine droop. However, the inventor of the present application has found that when the compressive load of the resin ring 10 is 2 to 10 N, the uterus can be sufficiently supported, so that a therapeutic effect on uterine prolapse or uterus is obtained. That is, the ring pessary 1 of the present invention can be sufficiently removed from the uterus or the uterus by using the soft and easily deformable resin ring 10 (previously considered to be unusable for the treatment of uterine prolapse or uterus). This is a novel ring pessary 1 that is easy to mount and take out.
The compressive load of the resin ring 10 is preferably 2 to 8N, and more preferably 3 to 5N. Thereby, the ring pessary 1 which can be easily inserted into the body and is suitable for treatment of uterine prolapse or uterine drooping can be provided.

The resin ring 10 used for the ring pessary 1 is required to return to a circular shape to some extent in a relatively short time after being inserted into the vagina and unloading the loads F ₁ and F ₂ . If the resin ring 10 does not return to a substantially circular shape, the resin ring 10 cannot fit well under the vaginal lid 93 and cannot support the uterus from below. Further, when the resin ring 10 is in the state of being elongated and deformed, the ring pessary 1 easily passes through the vagina 91 downward due to gravity and falls off the body. Therefore, the resin ring 10 needs an appropriate restoring force (a force for returning to the original shape after removing the load for deforming the resin ring 10). Specifically, it is desirable that the resin DD 10 has a restoring force such that the outer dimension DD of the resin ring 10 at 30 seconds after unloading is 70% or more of the outer diameter OD of the resin ring 10. Here, if it is defined as “restoration rate = DD / OD × 100 (%)”, it can be said that the resin ring 10 having a restoration rate of 70% or more 30 seconds after unloading is desirable.

When the resin ring 10 is completely circular (the outer dimension DD of the resin ring 10 = the outer diameter OD of the resin ring 10), the resin ring 10 is placed at a predetermined position at the upper end of the vagina 91 (the space below the vaginal lid 93). Fits tightly and holds in place. However, if it is slightly deformed, it can be held at a predetermined position without any problem. For example, when the restoration rate is 70% or more, the upper end of the vagina 91 can be held at a predetermined position.

In the regulation of the restoration rate, “30 seconds after unloading” is assumed to be 30 seconds after the patient releases the fingertip after the ring pessary 1 is deformed and inserted into the vagina 91. If there are 30 seconds after the unloading, the ring pessary 1 inserted into the vagina 91 can be positioned at a predetermined position at the upper end of the vagina 91 (a space below the vaginal lid 93). Therefore, if the resin ring 10 is restored to 70% or more of the outer diameter OD when the resin ring 10 is positioned at a predetermined position 30 seconds after unloading, the resin ring 10 is held at the predetermined position as it is. be able to.

That is, if the resin ring 10 has a recovery rate of 70% or more 30 seconds after unloading, the resin ring 10 is positioned at a predetermined position under the vaginal lid 93 within 30 seconds after unloading and is held in that position. Therefore, the ring pessary 1 can be easily attached. In particular, the restoration rate after 30 seconds after unloading is preferably 80% or more, and particularly preferably 90% or more.

Referring to FIG. 1 again, the ring pessary 1 may include a soft film 20 that covers the opening 16 on the lower surface 12 side of the resin ring 10. When the ring pessary 1 with the soft film 20 is inserted into the upper end of the vagina 91, the lower side of the uterine vagina part 94 fitted inside the resin ring 10 is covered with the soft film 20 (FIG. 2 (a), ( b)). At this time, if the lower surface 12 of the resin ring 10 is covered with the soft film 20, the lower part can be received by the soft film 20. In particular, depending on the patient who is being treated with the ring pessary 1, there may be an increase in the lower band, but by using the ring pessary 1 with the soft film 20, the lower film is received by the soft film 20. Can do. Thereby, the discomfort by the belt can be reduced. It can also be used during menstruation, and can also be used as a sanitary product for preventing uterine prolapse and uterine drooping.

In addition, in the case of a patient who tends to cause vaginitis or the like due to the use of ring pessary 1, vaginal tablets may be used in combination with ring pessary 1 for the treatment of vaginitis or for the prevention of vaginitis. At this time, if the ring pessary 1 having the soft film 20 is placed after putting the vaginal tablet in the upper end of the vagina, the vaginal tablet and the dissolved vaginal tablet dissolved in the vagina are held on the upper end of the vagina by the soft film 20. Can be expected to increase the effect of medication.
The soft film 20 may be formed from a film that covers the lower surface of the resin ring 10 flatly. However, when the film is swollen downward as shown in FIG. Since it becomes easy to do, it is preferable.

The soft film 20 may be fixed to the lower surface 12 side of the resin ring 10 by adhesion, fusion, or the like. Moreover, you may fix the soft film 20 to the resin ring 10 by winding the edge part etc. of the soft film 20 around the resin ring 10 as a core material.

In the case of the ring pessary 1 provided with the soft film 20, the compression load and the restoration rate of the resin ring 10 are the compression load and the restoration rate of the resin ring 10 measured with the soft film 20 for the following reason. Preferably there is.
The compressive load of the resin ring 10 is defined so that the ring pessary 1 to be used can be easily inserted into the body. The restoration rate of the resin ring 10 is defined so that the ring pessary 1 to be used is securely held at a predetermined position after being inserted into the body. That is, in the ring pessary 1 actually used, the resin ring 10 needs to have a predetermined compression load and a predetermined restoration rate. Therefore, in the ring pessary 1 provided with the soft film 20, the resin ring 10 provided with the soft film 20 needs to have the compression load and the restoration rate defined in the present invention.
As will be described later, the ring pessary 1 according to the present embodiment can have various additional configurations such as a medicine holding part, a string attaching part, and a protruding part. In that case, the compressive load and the restoration rate of the resin ring 10 are the compressive load and the restoration rate of the resin ring 10 measured in a state having these additional configurations.

FIGS. 4 (a) to 4 (b) and FIGS. 5 (a) to 5 (b) show a ring pessary 1 including resin rings 10 having various cross-sectional shapes. These cross sections are cross sectional views taken along a line extending in the diameter direction of the resin ring 10 (specifically, a line AA in FIG. 1B).
The ring pessary 1 in FIG. 4A includes a resin ring 10 having a rectangular cross-sectional shape. A feature of the resin ring 10 having such a cross-sectional shape is that a flat outer surface 13 is provided. When the ring pessary 1 is disposed in the vagina, the flat outer surface 13 contacts the vagina wall 95, so that the ring pessary 1 can be stably held at a predetermined position on the upper end of the vagina. Therefore, even when the compressive load of the resin ring 10 is small (that is, in the case of the resin ring 10 that is easily deformed), the ring pessary 1 that does not easily fall out of the body can be obtained.

Further, when the patient takes out the ring pessary 1, the outer surface 13 of the resin ring 10 is pinched with two or more fingertips inserted into the vagina 91 and pulled out of the body. At this time, if the outer surface 13 of the resin ring 10 is flat, the fingertip is less likely to slip when the outer surface 13 is pinched with the fingertip, as compared to the resin ring 10 having a circular cross-sectional shape (FIG. 4D). Therefore, the patient can easily take out the ring pessary 1.

Particularly, in the cross-sectional shape of the resin ring 10, it is preferable that the outer side surface 13 and the inner side surface 14 of the resin ring 10 have long sides and the upper surface 11 and the lower surface 12 have short sides. In other words, as shown in FIGS. 1 and 4A, the resin ring 10 having a width W (dimension in the z direction) larger than the thickness T (dimension in the diameter direction) of the resin ring 10 is preferable. Thereby, since the area of the outer side surface 13 of the resin ring 10 can be enlarged, the drop-off prevention effect of the ring pessary 1 can be improved. In addition, the patient can easily take out the ring pessary 1.

The ring pessary 1 in FIG. 4B is a modification of the ring pessary 1 in FIG. Specifically, an edge (outer upper edge) ED ₁ between the outer surface 13 and the upper surface 11 and an edge (outer lower edge) ED ₂ between the outer surface 13 and the lower surface 12 are chamfered with a curved surface. ing. Since the outer upper edge ED ₁ and the outer lower edge ED ₂ contact the vagina wall 95 when the ring pessary 1 is placed in the vagina (FIG. 2B), the edges ED ₁ and ED ₂ are chamfered. Thus, damage to the vagina wall 95 due to the edges ED ₁ and ED ₂ can be suppressed.

The edge between the inner side surface 14 and the upper surface 11 (inner upper edge ED ₃ ) is also preferably chamfered with a curved surface. Since the inner upper edge ED ₃ can come into contact with the vaginal lid 93 when the ring pessary 1 is placed in the vagina (FIG. 2B), the inner upper edge ED ₃ is chamfered so that the inner upper edge ED ₃ is chamfered. ₃ can prevent the vaginal lid 93 from being damaged.
Since the edge between the inner surface 14 and the lower surface 12 (inner lower edge ED ₄ ) is less likely to contact the soft tissue in the vagina 91 than the other edges, the inner lower edge ED ₄ is applied to the soft tissue in the vagina 91. Less likely to cause damage. However, since the soft tissue in the vagina 91 is delicate, it is preferable to chamfer the inner lower edge ED _{4 with a} curved surface to reliably avoid the risk of damaging the soft tissue.

The ring pessary 1 in FIG. 5A is a modification of the ring pessary 1 in FIG. 4B so that the edges ED ₁ to ED ₄ of the resin ring 10 are completely eliminated. The characteristic of the ring pessary 1 in FIG. 5A is that the cross-sectional shape of the resin ring 10 includes a linear outer surface 13 and an upper surface 11 having a convex curve. Since the outer side surface 13 is straight (that is, the outer side surface 13 is flat), the effect of preventing the ring pessary 1 from falling off and the patient's own removal of the ring pessary 1 are easy as in the ring pessary 1 of FIG. Sexual effect is obtained. When the upper surface 11 of the resin ring 10 is a convex curved surface (similar to the shape of the vaginal lid 93), the upper surface 11 supports the vaginal cap 93 from below for the treatment of uterine prolapse or uterine drooping. In addition, it is possible to avoid applying excessive force to the vaginal lid 93. Thereby, while suppressing the damage of the vaginal lid 93, the effect of suppressing vaginitis can also be expected.
The ring pessary 1 may include a resin ring 10 having a circular cross-sectional shape as shown in FIG.

6 (a) to 6 (b) show the ring pessary 1 provided with the soft film 20 having various shapes. The ring pessary 1 in FIG. 6A has a shape in which the central portion of the soft film 20 extends downward (−z direction). The ring pessary 1 in FIG. 6B has a shape in which the entire soft film 20 is pulled downward about a point that is shifted from the center position in the y direction. Thus, when the flexible film 20 is extended downward, the ring pessary 1 can be taken out from the vagina relatively easily by pulling the extended portion with a fingertip.

7 (a) to (b) and FIGS. 8 (a) to (c), the resin ring 10 may include a medicine holding portion 18 for holding medicine. It is known that treatment with the ring pessary 1 is likely to cause vaginitis near the upper end of the vagina where the ring pessary 1 comes into contact. Drugs (eg, estriol) that are administered vaginally are used for the prevention of vaginitis or for the treatment after the onset of vaginitis. By inserting the ring pessary 1 into the vagina while holding such a drug in the drug holding part 18 of the resin ring 10, treatment of uterine prolapse or uterus and drug administration can be performed simultaneously. .

In particular, the ring pessary 1 of the present invention can be attached and detached by the patient every day. Therefore, on the day when medication is required, the drug is placed in the drug holding unit 18 and then the ring pessary 1 is used, and no medication is required. Can use the ring pessary 1 without a drug. Since medication can be controlled in this way, unnecessary medication can be avoided.
As a medicine to be put in the medicine holding part 18, various forms such as tablets, powders, jellys and the like can be used. It is easy for the patient to put the medicine in the tablet into the medicine holder 18. On the other hand, the amount of the powdery or jelly-like medicine can be easily adjusted in the medicine holding part 18.

7 (a) to 7 (b) show concave drug holding portions 18 (181a, 181b) provided on the inner side surface 14 of the resin ring 10. FIG. When the medicine holding portion 18 is formed on the inner side surface 14, when the ring pessary 1 is placed in the vagina, the uterine vagina portion 94 (FIGS. 2A and 2B) fitted inside the resin ring 10 is provided. On the other hand, since the drug can be disposed in proximity, the therapeutic effect on the uterine vagina part 94 can be enhanced.

The drug holding part 181a shown in FIGS. 7 (a) to 7 (b) has an elliptical shape when viewed from the front, but is not limited to this, and is circular according to the ease of putting the drug, the dosage form of the tablet, etc. It can be a polygon (triangle, quadrangle, pentagon, etc.). Further, the medicine holding part 181a is not limited to a concave part having a constant depth as shown in the figure (that is, a concave part having a flat bottom surface), and may be a concave part whose depth changes. For example, when the tablet dosage form is rounded, a concave portion having a rounded bottom surface can be formed accordingly.

FIG. 7 (b) also shows a drug holding unit 181b for the purpose of suppressing tablet dropout as a modified example of the drug holding unit 181a. The medicine holding part 181b has a dimension 181x of an opening opened on the inner surface 14 side slightly smaller than the outer dimension of the tablet, and a maximum dimension 181y of the medicine holding part 181b larger than the outer dimension of the tablet. By expanding the opening and storing the tablet in the medicine holding part 181b, it is possible to prevent the tablet from dropping from the medicine holding part 181b.

When providing the medicine holding part 18 on the inner side surface 14 of the resin ring 10, it is preferable to provide a soft film 20. When a drug is put in the drug holding unit 18, powdered or jelly-like drugs may spill out from the drug holding unit 18, but if the soft film 20 is provided, the drug can be received by the soft film 20. Moreover, after the ring pessary 1 is placed in the vagina, when the drug is dissolved in the body fluid, the dissolved drug is received by the soft film 20 so that it can be prevented from flowing out of the body. In addition, since the chemical | medical agent collected on the soft film 20 will be hold | maintained at the upper end of the vagina 91 (FIG.2 (b)), the prevention of vaginitis or the vaginitis can heighten the effect of the treatment after a symptom. .

FIG. 8A shows concave drug holding portions 18 (182 a and 182 b) provided on the outer side surface 13 of the resin ring 10. When the medicine holding portion 18 is formed on the outer surface 14, the medicine is brought close to the vagina wall 95 (FIG. 2B) with which the outer surface 13 of the resin ring 10 contacts when the ring pessary 1 is disposed in the vagina. Therefore, the therapeutic effect on the vaginal wall 95 can be enhanced.
Note that the shape of the concave portion (for example, the shape of the front view, the depth of the concave portion, etc.) constituting the medicine holding portion 182a shown in FIG. 8A is shown in FIGS. 7A to 7B. This is the same as the medicine holding unit 181a.

FIG. 8 (a) also shows a drug holding part 182b for the purpose of suppressing tablet dropout as a modified example of the drug holding part 182a. The medicine holding part 182b has a dimension 182x of an opening opened on the outer surface 13 side slightly smaller than the outer dimension of the tablet, and a maximum dimension 181y of the medicine holding part 182b larger than the outer dimension of the tablet. By expanding the opening and storing the tablet in the medicine holding part 182b, it is possible to suppress the tablet from dropping off from the medicine holding part 182b.

FIG. 8 (b) shows a drug holding portion 18 (183 a, 183 b) composed of a through hole penetrating from the inner side surface 14 to the outer side surface 13 of the resin ring 10. Since the medicine holding part 18 communicates with both the inner side surface 14 and the outer side face 13, the effect of the medicine holding part 181a shown in FIGS. 7A and 7B and the medicine holding part shown in FIG. Part 182a. That is, since the medicine holding part 18 shown in FIG. 8B communicates with the inner side surface 14, the therapeutic effect on the uterine vagina part 94 (FIG. 2B) fitted inside the resin ring 10 is enhanced. Can do. Furthermore, since the medicine holding portion 18 shown in FIG. 8B communicates with the outer side surface 13, the therapeutic effect on the vagina wall 95 (FIG. 2B) can be enhanced.

The shape of the medicine holding portion 183a shown in FIG. 8B in a front view is a circle, an ellipse, a polygon (triangle, quadrangle, pentagon, etc.), etc. according to the ease of putting the medicine, the dosage form of the tablet, etc. be able to.
FIG. 8 (b) also shows a drug holding part 183b for the purpose of suppressing tablet dropout as a modified example of the drug holding part 183a. The medicine holding part 183b has a dimension 183x of an opening opened on the inner side surface 14 side slightly smaller than the outer dimension of the tablet, a maximum dimension 183y of the medicine holding part 183b larger than the outer dimension of the tablet, and the outer side face 13 The dimension 183z of the opening that opens to the side is significantly smaller than the outer dimension of the tablet. By opening the opening opened on the inner side surface 14 side and storing the tablet in the medicine holding part 183b, it is possible to prevent the tablet from dropping off from the medicine holding part 183b.

When inserting a tablet from the outer surface 13 side of the resin ring 10, the dimension 181x of the opening on the inner surface 14 side is made significantly smaller than the outer dimension of the tablet, and the opening dimension 183z on the outer surface 13 side is set to the outer dimension of the tablet. It may be made slightly smaller.
In addition, both the dimension 181x of the opening on the inner surface 14 side and the dimension 183z of the opening on the outer surface 13 side may be slightly smaller than the outer dimension of the tablet. Tablets can be inserted from the 13th side.

In the case of the medicine holding part 18 composed of a through hole, it is preferable that the soft film 20 is provided. For example, when a medicine is put into the medicine holding part 18 from the outer surface 14 side, the powdery or jelly-like medicine may pass through the penetrating medicine holding part 183a and spill out from the inner side face 14 side. However, if the soft film 20 is provided, the drug can be received by the soft film 20. Moreover, after the ring pessary 1 is placed in the vagina, when the drug is dissolved in the body fluid, the drug flowing out from the inner side surface 14 side is received by the soft film 20 so that it can be prevented from flowing out of the body. In addition, since the chemical | medical agent collected on the soft film 20 will be hold | maintained at the upper end of the vagina 91 (FIG.2 (b)), the prevention of vaginitis or the vaginitis can heighten the effect of the treatment after a symptom. .

7 (a) to 7 (b) and FIG. 8 (a) disclose a medicine holding portion 18 composed of a concave portion provided on the inner side surface 14 or the outer side surface 13, but this concave portion is elongated along the circumference. It can also be used as the chemical | medical agent holding part 18 which extends and consists of a groove part. For example, FIG. 8C illustrates a groove-shaped medicine holding portion 18 (184) provided along the circumference of the inner side surface 14 of the resin ring 10. Although not shown, a groove-shaped drug holding portion provided along the circumference of the outer side surface 13 of the resin ring 10 can also be provided. The groove-shaped drug holding part 18 can be made larger than the concave drug holding part 18 so that the volume in which the drug can be put is wide, which is advantageous when it is desired to increase the dosage of the drug. In the case of tablets, since the medicine can be held only by being fitted into the groove, any number of tablets can be held at any place.

As shown in FIG. 9, the ring pessary 1 can include a string 30 that is used when the ring pessary 1 is taken out from the vagina. The string 30 has a rear end 31 firmly attached to an attachment position 190 of the resin ring 10, and a tip 32 is a free end that is not fixed. When the ring pessary 1 with the string 30 is used, the string 30 is arranged to extend from the resin ring 10 (FIG. 2A) held at the upper end of the vagina 91 to the outside of the body along the vagina 91. The patient can easily remove the ring pessary 1 by manually pulling the tip 32 of the string 30. Since the resin ring 10 of the ring pessary 1 can be greatly deformed with a small compressive force, the resin ring 10 is pulled when the string 30 is pulled in the external direction (arrow P direction) with the ring pessary 1 placed at the upper end of the vagina 91. Is compressed from both sides by the vaginal wall 95 (FIG. 2 (a)) and deformed into an elongated shape (see the resin ring 10 ″ indicated by the broken line). In such a deformed state, it can pass through the vagina 91 and be taken out of the body, so that no strong pain is felt when taking out.
By providing the string 30, the ring pessary 1 can be taken out without inserting a finger into the vagina. Therefore, even a patient who is unaccustomed to self-removal of the ring pessary 1 can take out the ring pessary 1 relatively easily.
In addition, it is preferable to use the string 30 having such a length that the tip 32 of the string 30 is sufficiently exposed outside the body so that the string 30 can be easily pulled.

As shown in FIG. 10A, the ring pessary 1 ′ (without the soft film 20) can include a string attachment portion 19 for attaching the string 30 to the resin ring 10. 10A includes a through hole extending from the inner side surface 14 to the outer side surface 13 of the resin ring 10. The string 30 can be fixed to the resin ring 10 by inserting the string 30 into the string attaching portion 19 and tying it. When the string 30 is fixed, the string 30 can be detachably attached to the resin ring 10 by being tied so that it can be unwound.

Although the string 30 may take any form, for example, as shown in FIG. 11A, the string 30 having the other end 31 formed into a ring may be used to facilitate attachment / detachment of the string 30. Can do. A method for attaching the string 30 to the string attaching portion 19 will be described with reference to FIG. First, the tip 32 of the string 30 is inserted into the string attachment portion 19 from the inner surface 14 side of the resin ring 10 and pulled out to the outer surface 13 side. At this time, the ring at the rear end 31 of the string 30 is left protruding from the inner side surface 14 side of the resin ring 10. Thereafter, the tip 32 is directed to the inner surface 14 side through the lower surface 12 side of the resin ring 10. Then, the front end 31 of the string 30 is pulled downward after passing through the ring at the rear end 31 of the string 30 that is projected to the inner surface 14 side. Thereby, the string 30 can be easily attached to the string attaching part 19. Moreover, since the knot of the string 30 is not located on the outer side surface 13 (contacts with the vagina wall) or the upper surface 11 (contacts with the vaginal vault) of the resin ring 10, it is difficult to damage the soft tissue in the vagina 91. Can do.

Since the string 30 can be attached / detached by providing the string attaching portion 19, the string 30 can be used properly according to the patient's proficiency with respect to the self attachment / detachment of the ring pessary 1. That is, while the patient is unaccustomed to self-removal of the ring pessary 1, the ring pessary 1 with the string 30 is used, and when the patient gets used to self-removal, the ring pessary 1 can be used without attaching the string 30. .

12 (a) to 12 (b) show another embodiment of the string attaching portion 19. FIG.
As shown in FIG. 12A, a small annular protrusion can be provided on the lower surface 12 of the resin ring 10 to form the string attaching portion 19. To attach the string 30, the string 30 may be tied to the hole (through hole portion of the annular protrusion) of the string attaching portion 19 after passing through the string 30.
Further, as shown in FIG. 12B, in the ring pessary 1 having the soft film 20 on the lower surface 12 of the resin ring 10, a hole can be made in the soft film 20 to form the string attaching portion 19. In order to attach the string 30, the string 30 may be passed through the hole and then wound around the resin ring 10 before being tied. In addition, when making a hole in the soft film 20, forming in the vicinity of the resin ring 10 is preferable.
The string attaching portion 19 is not limited to the form shown in FIGS. 11 to 12, and any form may be used as long as the string 30 can be attached to the resin ring 10.

As shown in FIGS. 10 and 12, it is preferable that two or more string attaching portions 19 are provided. By using two or more string attachment portions 19 alternately, the deterioration of the string attachment portions 19 can be delayed and the life of the ring pessary 1 can be extended.
Further, as to the formation positions of the two or more string attachment portions 19, as shown in FIG. 10B, the center point O of the resin ring 10 and the first string attachment portions 19 (19a) when viewed from above. The angle θ formed by the first straight line La connecting the first point La and the second straight line Lb connecting the center point O and the second string attaching portion 19 (19b) is 60 ° to 120 ° (in FIG. 10B, θ = 90 °) is preferable. The angle θ is more preferably 80 to 100 °, and most preferably 90 °.
By arranging the plurality of string attaching portions 19 so that the angle θ is an appropriate angle, the shape of the resin ring 10 can be prevented from collapsing for the reason described in detail below.

In the ring pessary 1 shown in FIG. 10 (b), the resin ring 10 includes two

string attaching portions

19a and 19b, and an angle θ between the straight lines La and Lb passing through them is 90 °. On the first treatment day, treatment is performed with the ring pessary 1 in which the string 30 is fixed to the first string attachment portion 19a. On the second treatment day, the treatment is performed with the ring pessary 1 in which the string 30 is fixed to the second string attachment portion 19b. Give treatment.

When the first day of treatment is completed and the ring 30 is removed from the body by pulling the string 30 attached to the first string attaching part 19a, the resin ring 10 is moved to the first straight line passing through the first string attaching part 19a. It is deformed into a shape elongated in the La direction (y direction) (see the resin ring 10a shown by a broken line). At this time, the resin ring 10 is pulled in the y direction and compressed in the x direction.
When the second day of treatment is completed and the ring 30 is removed from the body by pulling the string 30 attached to the second string attachment part 19b, the resin ring 10 becomes a second straight line passing through the second string attachment part 19a. It is deformed into a shape extending in the Lb direction (x direction) (see the resin ring 10b shown by a one-dot chain line). At this time, the resin ring 10 is compressed in the y direction and pulled in the x direction, contrary to the first treatment day.

“Internal strain” may remain in the resin ring 10 due to the tensile stress in the y direction and the compressive stress in the x direction applied to the resin ring 10 on the first day of treatment. However, the “internal strain” generated on the first day of treatment is canceled or alleviated by the compressive stress in the y direction and the tensile stress in the x direction applied to the resin ring 10 on the second day of treatment. Become. Thereby, the internal strain of the resin ring 10 is less likely to remain in the long term, and the life of the ring pessary 1 can be extended.

In addition, in FIG.10 (b), although the example of the resin ring 10 which provided the two string attachment parts 19 so that it might become angle (theta) = 90 degrees was shown, angle (theta) is not limited to 90 degrees. For example, in the case of an angle θ = 120 ° (that is, when three string attachment portions 19 are provided at equal intervals on the resin ring 10), on the first day of treatment, the string 30 is attached to the first string attachment portion, By attaching the string 30 to the second string attachment part on the second day and the third string attachment part on the third day, the internal strain of the resin ring 10 can be offset or alleviated by treatment for three days. . Further, when the angle θ = 60 ° (that is, when six string attaching portions 19 are provided at equal intervals on the resin ring 10), the internal strain of the resin ring 10 can be offset or alleviated by treatment for 6 days. .

As described above, when the angle θ is 60 ° to 120 °, the patient himself changes the lace attachment portion 19 to which the lace 30 is attached every day to treat the uterine prolapse or uterus with the ring pessary 1 for 2 to 6 days. It is possible to cancel or alleviate the internal strain of the resin ring 10 only by performing it.

As shown in FIG. 13, the ring pessary 1 can include a rod-shaped protrusion 22 that is used when the ring pessary 1 is taken out from the vagina. In addition, the protrusion part 22 can be formed from the rod-shaped member of various forms, such as a rectangle, circular shape, and an ellipse, in cross section. The protrusion 22 may be hollow or solid.
The rod-shaped protrusion 22 can be provided on the ring pessary 1 with one end fixed to the lower surface 21 of the soft film 20 and the other end extending downward. When the ring pessary 1 is installed on the vaginal lid 93 (FIG. 2), the lower surface 21 of the soft film 20 is disposed on the vagina 91 side, and the protrusion 22 fixed to the lower surface 21 of the soft film 20 It protrudes downward.
When taking out the ring pessary 1 provided with the protrusion 22 from the body, a finger is inserted into the vagina, and the protrusion 22 is grasped and pulled by the fingertip. Since the protrusion 22 protrudes downward in the vagina 91, if the finger is inserted into the vagina 91 shallowly, the protrusion 22 can be grasped by the fingertip. Therefore, the ring pessary 1 can be taken out relatively easily even by an inexperienced patient.

A slip stopper 23 can be provided on the surface of the protrusion 22. When the protrusion 22 is grasped and pulled by the fingertip, the fingertip can be prevented from sliding with body fluid or the like. The anti-slip 23 can be in various forms such as a belt-like convex portion provided on the surface of the protruding portion 22, an island-shaped convex portion, and a groove portion. In particular, as shown in FIG. 13, a non-slip 23 comprising a belt-like convex portion extending around the rod-like projection 22 is preferable.

A string used when the ring pessary 1 is taken out can be attached to the protrusion 22. For example, a string can be tied to the protrusion 22. The string can be extended from the protrusion 22 along the vagina 91 to the outside of the body. The patient can pull out the ring pessary 1 by pulling the protrusion 22 through the string by manually pulling the end of the string exposed outside the body. By attaching a string to the protrusion 22, it is not necessary to put a finger into the vagina when the ring pessary 1 is taken out.
In the case where the protrusion 22 is provided with the anti-slip 23, it is preferable that a string is tied to the protrusion 22 above the anti-slip 23. When the string is pulled to take out the ring pessary 1, it is possible to prevent the string from being caught by the anti-slip 23 and coming out of the protrusion 22.

In the ring pessary 1 shown in FIG. 13, the protrusion 22 is fixed at the center position of the flexible film 20, but is not limited to this. For example, as shown in FIG. 13, the protrusion 22 may be fixed to the soft film 20 at a position shifted from the center in the y direction of the soft film 20. Further, as shown in FIG. 13, in addition to the form in which the protrusion 22 extends vertically downward, the protrusion 22 can be inclined and extended as shown in FIG. When the ring pessary 1 with the protruding portion 22 inclined as described above is mounted, the ring pessary 1 is preferably installed in the vagina 91 so that the inclined direction of the protruding portion 22 coincides with the front side of the body. Thereby, the protrusion direction (downward front side of the body) of the protrusion 22 can be adapted to the anatomical form of the lumen of the vagina 91 (inclined downward from the vagina toward the vaginal opening). Further, when the ring pessary 1 is taken out from the vagina 91, the protrusion 22 extends in the same direction as the lumen of the vagina 91, so that it is easy to pull the protrusion 22 along the anatomy of the vagina 91. The ring pessary 1 can be taken out smoothly.

Further, as shown in FIGS. 15 and 16, the protrusion 22 can be provided on the soft film 20 having a portion extending downward. For example, the ring pessary 1 shown in FIG. 15 has a soft film 20 having a configuration as shown in FIG. 6A, and a protrusion 22 is fixed to the lowest point of the soft film 20 (near the center of the extended portion). Has been. In the ring pessary 1 of FIG. 16, it has the soft film 20 of the form as shown in FIG.6 (b), and is at the lowest point of the soft film 20 (point shifted from the center position of the soft film 20 in the y direction). The protrusion 22 is fixed. When the ring pessary 1 of FIGS. 15 and 16 is placed in the vagina, the protrusion 22 is located in the vicinity of the vaginal opening, so when removing the ring pessary 1 from the body, just inserting the finger shallowly near the vaginal opening, The protrusion 22 can be grasped with a fingertip. Therefore, the ring pessary 1 can be easily taken out even by an inexperienced patient.

The components of the ring pessary 1 will be described in detail below.

(Resin ring 10)
The resin ring 10 is a ring-shaped member having a through hole inside. The dimensions of the resin ring 10 can be, for example, an outer diameter OD = 5 to 9 cm, a width W = 0.5 cm to 1 cm, and a thickness T = 0.2 cm to 0.6 cm. The compression load of the resin ring 10 (= the load necessary for compressing the outer diameter OD to the outer dimension DD = 2 cm) is 2 to 10 N, and can be greatly deformed by the fingertip.
The resin ring 10 is formed of a biocompatible elastic material, and for example, a polymer material such as silicone rubber, nylon, and polyvinyl chloride is suitable.

(Soft film 20)
The soft film 20 is for receiving a liquid or the like by covering the hollow portion inside the resin ring 10 from the lower surface 11 side. Since the flexible film 20 receives liquid, it is basically desirable that there is no hole. However, since the amount of liquid to be received is not so large, for example, for the purpose of providing the string attaching portion 19, a hole may be partially formed. In addition, when opening a hole, avoiding the center of the soft film 20 and making it in the vicinity of the resin ring 10, it is difficult to impair the function of receiving the liquid.
It is preferable that the flexible film 20 is molded into a shape that hangs down at the center, because the liquid can be easily received.
The flexible film 20 is made of a biocompatible film material, and a polymer material film such as a silicone rubber film, a nylon film, or a polyvinyl chloride film is preferable.

(Protrusion 22, anti-slip 23)
The protrusion 22 and the anti-slip portion 23 are made of a biocompatible material, and for example, a polymer material such as silicone rubber, nylon, polyvinyl chloride, and thermoplastic elastomer is suitable.
By forming the protrusion 22 and the slip stopper 12 from the same material as that used for the soft film 20, the protrusion 22, the slip stopper 12 and the soft film 20 can be formed integrally.
The protrusion 22 and the anti-slip 12 may be made of a material different from that used for the soft film 20. In that case, what is necessary is just to shape | mold the soft film 20, the protrusion part 22, and the anti-slip | skid 12 separately, and to fix the end of the protrusion part 22 to the lower surface 21 of the soft film 20 later.

(String 30)
The string 30 is used to make it easy for the patient to take the ring pessary 1 out of the body. The string 30 is formed of a material having a sufficiently high tensile strength so that the string 30 is not cut during the removal of the ring pessary 1. Moreover, since the string 30 is a member that contacts body fluid, it is preferably formed from a material that does not easily cause problems such as a decrease in tensile strength due to contact with the body fluid. Further, it is preferable that the string 30 is made of a material having a certain thickness and softness so as not to damage the vagina wall 95 and the like when moving in the vagina 91.
The string 30 is formed from a biocompatible string-like material, for example, a string-like material made of a natural material such as cotton or silk, or a polymer material such as a silicone rubber film, nylon, or polyvinyl chloride film. A string-like material is preferred.

Example 1
About the resin ring 10 used for the ring pessary 1, the compression load required to make the outer dimension 2 cm was measured. A silicone rubber resin ring 10 was used as a measurement sample. The resin ring 10 had an outer diameter OD = 7 cm, and its cross-sectional shape was a rectangle (width W = 0.8 cm, thickness T = 0.4 cm) long in the width direction. The compression load of the resin ring 10 was measured in accordance with JIS K 6254: 2010 “Vulcanized rubber and thermoplastic rubber-Determination of stress / strain characteristics”. In the measurement, a load was applied to the resin ring 10 in the diameter direction (loading process), and the outer dimension was compressed from 7 cm (no load) to 2 cm (displacement 5 cm). Thereafter, the load was gradually reduced (unloading process). The test speed (deformation speed of the outer dimension) was 20 cm / min. That is, the loading process was 15 seconds and the unloading process was 15 seconds.

The experimental results of Example 1 are shown in FIG. FIG. 17 is a hysteresis-loss curve showing the loading process and the unloading process. In the loading process, the load required to make the displacement 5 cm (outer dimension 2 cm) was 5.34 N (about 0.54 kgf). Further, the resin ring 10 immediately after unloading had a strain of about 1 cm. That is, since the resin ring 10 has an outer diameter OD = 7 cm and the outer dimension DD immediately after unloading is about 6 cm, the restoration rate was about 85%.

(Comparative Example 1)
As a comparative example, for a commercially available ring pessary (made by Kitasato Medical Co., Ltd., trade name “Kitaza Tring Pessary”), a compressive load necessary to make the outer dimension 2 cm was measured. The ring pessary used was a nylon resin contract O-type ring pessary (hereinafter referred to as “ring sample”). The ring sample had an outer diameter OD = 7 cm and its cross-sectional shape was circular (diameter = 1 cm). The compression load measurement of the ring sample was the same as in Example 1.

The experimental results of Comparative Example 1 are shown in FIG. FIG. 18 is a hysteresis-loss curve showing the loading process and the unloading process. In the loading process, the load required to make the displacement 5 cm (outer dimension 2 cm) was 37.5 N (3.82 kgf). Further, the resin ring 10 immediately after unloading had a strain of about 0.1 cm. That is, since the resin ring 10 has an outer diameter OD = 7 cm and the outer dimension DD immediately after unloading is approximately 6.9 cm, the restoration rate is approximately 98%.

When the experimental results of Example 1 and Comparative Example 1 are compared, the resin ring 10 of Example 1 has a compression load of 5.34 N (about 550 g in terms of weight). It can be seen that it can be sufficiently deformed. On the other hand, the ring sample of Comparative Example 1 has a compressive load of 37.5 N (a little less than 4 kg in terms of weight), and it can be seen that it cannot be easily deformed by the fingertip of a female patient.

1, 1 'ring pessary 10 resin ring 18 drug holding part 19 string attachment part 20 soft film 22 pull-out part 30 string OD outer diameter of resin ring DD outer dimension of resin ring

Claims

A ring pessary for treating uterine prolapse or uterine droop for supporting the lower uterus and suppressing uterine prolapse or uterine drooping,
The ring pessary includes a resin ring,
The outer diameter of the resin ring is 5 to 9 cm, and the load required to compress the outer diameter to 2 cm is 2 to 10 N.
A ring pessary characterized in that an outer dimension of the resin ring 30 seconds after unloading is 70% or more of the outer diameter of the resin ring.
The ring pessary according to claim 1, wherein the resin ring has a substantially rectangular cross-sectional shape.
The ring pessary according to claim 1, wherein the resin ring has a cross-sectional shape including a linear outer surface and a curved upper surface convex upward.
The ring pessary according to any one of claims 1 to 3, further comprising a soft film that covers an opening on a lower surface side of the resin ring.
The ring pessary according to any one of claims 1 to 4, wherein the resin ring includes a medicine holding portion for holding a medicine.
The ring pessary according to any one of claims 1 to 5, further comprising a string for taking out the ring pessary.
The ring pessary includes a string attaching portion for attaching the string,
The ring pessary according to claim 6, wherein the string is detachably attached to the string attaching part.
The resin ring includes two or more string attachment portions,
The angle formed by the first straight line connecting the center point of the resin ring and the first string attaching portion and the second straight line connecting the center point and the second string attaching portion is 60 ° to 120 °. 8. The ring pessary according to claim 7, wherein the ring pessary is provided.
The ring pessary according to any one of claims 1 to 6, further comprising a protrusion for taking out the ring pessary.
The ring pessary according to claim 9, wherein the protrusion is provided on a lower surface side of a soft film that covers an opening on a lower surface side of the resin ring.