WO2015041353A1 - Pessaire annulaire pour le traitement d'un prolapsus de l'utérus ou d'une hystéroptose - Google Patents

Pessaire annulaire pour le traitement d'un prolapsus de l'utérus ou d'une hystéroptose Download PDF

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Publication number
WO2015041353A1
WO2015041353A1 PCT/JP2014/074962 JP2014074962W WO2015041353A1 WO 2015041353 A1 WO2015041353 A1 WO 2015041353A1 JP 2014074962 W JP2014074962 W JP 2014074962W WO 2015041353 A1 WO2015041353 A1 WO 2015041353A1
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WIPO (PCT)
Prior art keywords
ring
pessary
string
resin
resin ring
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Application number
PCT/JP2014/074962
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English (en)
Japanese (ja)
Inventor
潤子 八木
Original Assignee
潤子 八木
八木 太郎
八木 茉莉
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Application filed by 潤子 八木, 八木 太郎, 八木 茉莉 filed Critical 潤子 八木
Priority to JP2015537993A priority Critical patent/JPWO2015041353A1/ja
Publication of WO2015041353A1 publication Critical patent/WO2015041353A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
    • A61F6/08—Pessaries, i.e. devices worn in the vagina to support the uterus, remedy a malposition or prevent conception, e.g. combined with devices protecting against contagion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females

Definitions

  • 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.
  • 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).
  • a ring pessary is installed at the upper end of the vagina to support the lower uterus with the ring pessary.
  • 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.
  • 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.
  • 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.
  • 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.
  • FIG. 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. 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
  • FIG. 10 (b) is a top view
  • Fig.11 (a) is a front view of the string for attaching to a ring pessary
  • 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.
  • FIG. 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
  • 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.
  • the ring pessary 1 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 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.
  • 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).
  • 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.
  • 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.
  • pessaries early for example, after birth, at an early stage of uterine drooping
  • the ring pessary 1 is inserted into the upper end of the vagina 91 transvaginally from the direction of arrow X (FIG. 2A).
  • 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.
  • the ring pessary 1 can be inserted very easily. Therefore, the ring pessary 1 can be easily inserted even by a young mother.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the outer dimension DD of the resin ring 10 refers to the minimum outer dimension of the resin ring 10 after deformation or unloading.
  • 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.
  • 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).
  • the compressive load of the resin ring 10 is preferably 2 to 8N, and more preferably 3 to 5N.
  • 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).
  • 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.
  • 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.
  • 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.
  • the restoration rate after 30 seconds after unloading is preferably 80% or more, and particularly preferably 90% or more.
  • 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.
  • the soft film 20 FIG. 2 (a), ( b)
  • the lower part can be received by 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.
  • vaginal tablets may be used in combination with ring pessary 1 for the treatment of vaginitis or for the prevention of vaginitis.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 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.
  • the ring pessary 1 may include a resin ring 10 having a circular cross-sectional shape as shown in FIG.
  • FIG. 6A 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.
  • 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. .
  • Drugs eg, estriol
  • 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.
  • 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.
  • FIG. 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. 1 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.
  • 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.
  • a soft film 20 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.
  • a drug 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.
  • the ring pessary 1 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the soft film 20 is provided.
  • 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.
  • the soft film 20 is provided, the drug can be received by the soft film 20.
  • 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.
  • the prevention of vaginitis or the vaginitis can heighten the effect of the treatment after a symptom. .
  • FIG. 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
  • 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.
  • 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.
  • any number of tablets can be held at any place.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the string 30 can be detachably attached to the resin ring 10 by being tied so that it can be unwound.
  • 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.
  • 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.
  • the string 30 can be easily attached to the string attaching part 19.
  • 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.
  • 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. .
  • 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.
  • 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.
  • 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.
  • the string 30 may be passed through the hole and then wound around the resin ring 10 before being tied.
  • 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.
  • two or more string attaching portions 19 are provided.
  • the deterioration of the string attachment portions 19 can be delayed and the life of the ring pessary 1 can be extended.
  • the center point O of the resin ring 10 and the first string attachment portions 19 (19a) when viewed from above.
  • the angle ⁇ is more preferably 80 to 100 °, and most preferably 90 °.
  • the resin ring 10 includes two string attaching portions 19a and 19b, and an angle ⁇ between the straight lines La and Lb passing through them is 90 °.
  • treatment is performed with the ring pessary 1 in which the string 30 is fixed to the first string attachment portion 19a.
  • the treatment is performed with the ring pessary 1 in which the string 30 is fixed to the second string attachment portion 19b.
  • the resin ring 10 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.
  • “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.
  • angle (theta) 90 degrees
  • angle (theta) is not limited to 90 degrees.
  • angle ⁇ 120 ° (that is, when three string attachment portions 19 are provided at equal intervals on the resin ring 10)
  • the string 30 is attached to the first string attachment portion
  • the internal strain of the resin ring 10 can be offset or alleviated by treatment for three days.
  • the angle ⁇ 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. .
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the protrusion 22 is fixed at the center position of the flexible film 20, but is not limited to this.
  • 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.
  • the protrusion 22 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.
  • 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.
  • 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.
  • the protrusion 22 can be provided on the soft film 20 having a portion extending downward.
  • 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).
  • 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.
  • 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 resin ring 10 is a ring-shaped member having a through hole inside.
  • 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.
  • 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.
  • 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.
  • a polymer material such as silicone rubber, nylon, polyvinyl chloride, and thermoplastic elastomer is suitable.
  • 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
  • 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.
  • 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.
  • 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 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.
  • FIG. 17 is a hysteresis-loss curve showing the loading process and the unloading process.
  • the load required to make the displacement 5 cm was 5.34 N (about 0.54 kgf).
  • 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 compression load measurement of the ring sample was the same as in Example 1.
  • FIG. 18 is a hysteresis-loss curve showing the loading process and the unloading process.
  • the load required to make the displacement 5 cm was 37.5 N (3.82 kgf).
  • 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.
  • 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.

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  • Health & Medical Sciences (AREA)
  • Reproductive Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un pessaire annulaire pour le traitement d'un prolapsus de l'utérus ou d'une hystéroptose, l'anneau étant utilisé pour lutter contre le prolapsus de l'utérus ou l'hystéroptose par le support du segment utérin inférieur. Un pessaire annulaire (1) est caractérisé en ce que : il contient un anneau en résine (10) dont le diamètre externe OD est de 5-9 cm et la charge nécessaire pour comprimer ce diamètre externe à 2 cm est de 2-10 N ; les dimensions externes de l'anneau en résine, 30 secondes après avoir enlevé la charge, sont d'au moins 70 % du diamètre externe de l'anneau en résine.
PCT/JP2014/074962 2013-09-20 2014-09-19 Pessaire annulaire pour le traitement d'un prolapsus de l'utérus ou d'une hystéroptose WO2015041353A1 (fr)

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Cited By (10)

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WO2017031456A1 (fr) 2015-08-20 2017-02-23 Watkins-Conti Products, Inc. Dispositif de support intra-vaginal souple et en forme de cône
KR101806732B1 (ko) * 2016-08-25 2017-12-07 고려대학교 산학협력단 자궁경부 무력증에서 조산을 방지하기 위한 자궁경부 밴드 구조체
KR20170139279A (ko) * 2016-06-09 2017-12-19 고려대학교 산학협력단 자궁경부봉축술용 스트랩
KR101866665B1 (ko) * 2016-11-09 2018-06-11 고려대학교 산학협력단 반복 결찰이 가능한 자궁경부 봉축수술 장치
WO2019083071A1 (fr) * 2017-10-27 2019-05-02 고려대학교 산학협력단 Structure de bande cervicale pour empêcher une naissance prématurée résultant d'une faiblesse cervicale
EP3337434A4 (fr) * 2015-08-20 2019-06-05 Watkins-Conti Products, Inc. Dispositif de support intra-vaginal souple et en forme de cône
WO2021069619A1 (fr) * 2019-10-08 2021-04-15 Gruenspecht Naturprodukte Gmbh Coupe menstruelle
KR20210066428A (ko) * 2019-11-28 2021-06-07 인제대학교 산학협력단 생리컵
US11291535B2 (en) 2018-03-16 2022-04-05 Watkins-Conti Products, Inc. Intravaginal support devices and methods
KR20220131643A (ko) * 2021-03-22 2022-09-29 가톨릭대학교 산학협력단 산모 맞춤형 조산 예방용 페서리 및 이의 제조방법

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JPS5164793A (fr) * 1974-10-18 1976-06-04 Schering Ag
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AU2016308363B2 (en) * 2015-08-20 2020-08-27 Watkins-Conti Products, Inc. Flexible cone-shaped intra-vaginal support device
CN111658289A (zh) * 2015-08-20 2020-09-15 沃特金斯-康迪产品股份有限公司 柔性锥形阴道内支撑装置
CN108135732A (zh) * 2015-08-20 2018-06-08 沃特金斯-康迪产品股份有限公司 柔性锥形阴道内支撑装置
US11219548B2 (en) 2015-08-20 2022-01-11 Watkins-Conti Products, Inc. Flexible cone-shaped intra-vaginal support device
JP2018526169A (ja) * 2015-08-20 2018-09-13 ワトキンス−コンティ プロダクツ， インコーポレイテッド 可撓性円錐形状の膣内支持デバイス
WO2017031456A1 (fr) 2015-08-20 2017-02-23 Watkins-Conti Products, Inc. Dispositif de support intra-vaginal souple et en forme de cône
EP3337434A4 (fr) * 2015-08-20 2019-06-05 Watkins-Conti Products, Inc. Dispositif de support intra-vaginal souple et en forme de cône
KR20170139279A (ko) * 2016-06-09 2017-12-19 고려대학교 산학협력단 자궁경부봉축술용 스트랩
KR102586182B1 (ko) * 2016-06-09 2023-10-06 고려대학교 산학협력단 자궁경부봉축술용 스트랩
KR101806732B1 (ko) * 2016-08-25 2017-12-07 고려대학교 산학협력단 자궁경부 무력증에서 조산을 방지하기 위한 자궁경부 밴드 구조체
KR101866665B1 (ko) * 2016-11-09 2018-06-11 고려대학교 산학협력단 반복 결찰이 가능한 자궁경부 봉축수술 장치
KR20190047481A (ko) * 2017-10-27 2019-05-08 고려대학교 산학협력단 자궁경부 무력증에서 조산을 방지하기 위한 자궁경부 밴드 구조체
WO2019083071A1 (fr) * 2017-10-27 2019-05-02 고려대학교 산학협력단 Structure de bande cervicale pour empêcher une naissance prématurée résultant d'une faiblesse cervicale
KR102110132B1 (ko) * 2017-10-27 2020-05-13 고려대학교산학협력단 자궁경부 무력증에서 조산을 방지하기 위한 자궁경부 밴드 구조체
US11291535B2 (en) 2018-03-16 2022-04-05 Watkins-Conti Products, Inc. Intravaginal support devices and methods
WO2021069619A1 (fr) * 2019-10-08 2021-04-15 Gruenspecht Naturprodukte Gmbh Coupe menstruelle
KR20210066428A (ko) * 2019-11-28 2021-06-07 인제대학교 산학협력단 생리컵
KR102328099B1 (ko) * 2019-11-28 2021-11-17 인제대학교 산학협력단 생리컵
KR102571791B1 (ko) 2021-03-22 2023-08-28 가톨릭대학교 산학협력단 산모 맞춤형 조산 예방용 페서리 및 이의 제조방법
KR20220131643A (ko) * 2021-03-22 2022-09-29 가톨릭대학교 산학협력단 산모 맞춤형 조산 예방용 페서리 및 이의 제조방법

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