WO2014162363A1 - Intravaginal support tool and fluid injection device - Google Patents

Intravaginal support tool and fluid injection device Download PDF

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Publication number
WO2014162363A1
WO2014162363A1 PCT/JP2013/002378 JP2013002378W WO2014162363A1 WO 2014162363 A1 WO2014162363 A1 WO 2014162363A1 JP 2013002378 W JP2013002378 W JP 2013002378W WO 2014162363 A1 WO2014162363 A1 WO 2014162363A1
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WO
WIPO (PCT)
Prior art keywords
fluid
internal support
injection
bag
vagina
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Application number
PCT/JP2013/002378
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French (fr)
Japanese (ja)
Inventor
圭 本田
Original Assignee
テルモ株式会社
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Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to PCT/JP2013/002378 priority Critical patent/WO2014162363A1/en
Publication of WO2014162363A1 publication Critical patent/WO2014162363A1/en

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Classifications

    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/005—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra with pressure applied to urethra by an element placed in the vagina
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable

Definitions

  • the present invention relates to a vaginal internal support that can be used for the treatment of pelvic organ prolapse and that can be expanded and contracted while inserted into the vagina, and in particular, is intended to ensure conformity to the shape of the patient's vagina.
  • the present invention also relates to a fluid injection device for inflating the vaginal internal support, and particularly to facilitate fluid injection operation.
  • Pelvic organ prolapse is a disease in which the uterus, bladder, rectum, and other organs in the pelvis droop and escape from the body in severe cases. Such as symptoms.
  • vaginal births develop with aging and the number of potential patients in the country is 3.5 million.
  • a pessary usually consists of an elastically deformable ring body, which is inserted and placed in the patient's vagina by a doctor to support the drooping of the cervix, the anterior wall of the vagina, the posterior wall of the vagina, etc. Suppress.
  • a circular ring body is inserted into the vagina with an elliptical shape. While the inserted ring body is restored from an elliptical shape to a circular shape, the radial direction of the restored circular ring body is substantially perpendicular to the direction from the vaginal entrance to the back of the vagina. Is pressed against a region near the cervix side of a hard tissue derived from the pubic bone (hereinafter referred to as “pubic tissue”) in the anterior vaginal wall, and is locked to the pubic tissue through the anterior vaginal wall in the region. Is held in the vagina.
  • pubic tissue a hard tissue derived from the pubic bone
  • the surrounding soft vagina wall can be pushed and deformed, whereas in areas where the pubic tissue is deep, the depth leading to the pubic tissue The above indentation deformation is difficult.
  • the pessary is pressed against the region slightly behind the vagina than the region where the pubic tissue exists in the deep part of the vagina (that is, the region near the cervix side of the pubic tissue on the anterior vagina)
  • a recess is formed by the deformable region and the region in which push-in deformation is difficult, and the pessary is locked in the recess.
  • pessaries may cause off-flavors or bleeding from pressure points if left in the body for a long period of time. Or a new one needs to be inserted and placed.
  • the pessary has a ring body whose outer diameter is considerably larger than that of the vaginal entrance, and is not easy to remove. For this reason, as an alternative to the pessary, a vaginal internal support that can expand and contract in the vagina has been proposed.
  • the vaginal internal support described in Patent Document 1 is disposed on the vaginal entrance side and is inflatable via the valve, and is disposed on the back side of the vagina and inflated via another valve. And other shrinkable bags.
  • the vaginal internal support device described in Patent Document 1 cannot always be surely adapted to the shape of the patient's vagina. For this reason, the effect of suppressing pelvic organ prolapse has not been sufficiently obtained, and a compression site has been produced, causing problems such as bleeding and erosion.
  • the present invention has been developed in view of the above-described present situation, and an object thereof is to provide an intravaginal support that can be surely adapted to the intravaginal shape of a patient. It is another object of the present invention to provide a fluid injection device for inflating such a vaginal internal support, which can be easily injected with a fluid.
  • the intravaginal support device of the present invention is used for the treatment of pelvic organ prolapse, and in the intravaginal support device that can be inflated and contracted while inserted into the vagina, the open state where fluid is allowed to pass and the blocking of passage of fluid are blocked.
  • a balloon having an opening / closing portion that can be switched between states, and a bag portion that is inflatable by inflow of fluid through the opening / closing portion and contractable by outflow of fluid through the opening / closing portion.
  • an outer bag body which accommodates the bag portion of the balloon and can be inflated and contracted as the bag portion expands and contracts.
  • fluid means fluids, such as air, other gas, a liquid, or a viscous body, for example.
  • the vaginal internal support device of the present invention includes two or more balloons, and the outer bag body stores both of the bag portions of the two or more balloons, and the bag portions are expanded and contracted. It is preferable that it can expand and contract.
  • At least one of the two or more balloons can press the bag portion of the other balloon toward the anterior wall of the vagina by the expansion of the bag portion of the balloon. preferable.
  • the two or more balloons have different elastic compliances.
  • the elastic compliance is the reciprocal of the elastic modulus and is a physical quantity indicating the ease of deformation of the object.
  • a recess that can fit the cervix is formed on the outer surface of the outer bag body by inflating the two or more balloons.
  • the vaginal internal support device of the present invention further includes a ring-shaped pressing portion that surrounds all of the opening / closing portions of the one or more balloons, and each opening / closing portion allows fluid to flow into each bag portion.
  • each of the check valves has a check valve for blocking outflow of fluid from each bag portion, and each of the check valves presses the ring-shaped pressing portion inward at a predetermined circumferential position. It is preferable to allow fluid outflow from the bag portion.
  • the fluid injection device for inflating the vaginal internal support device of the present invention is connected to the vaginal internal support device and has an injection port having an injection port communicating with the opening and closing unit, and is sent to the injection port of the injection unit
  • the injection part is connected to the vaginal internal support device including two or more balloons, and the two or more communication parts communicate with the opening / closing parts of the two or more balloons.
  • the adjustment operation unit can adjust the amount of fluid sent to each injection port of the injection unit, and the injection operation unit supplies the amount of fluid adjusted by the adjustment operation unit, respectively.
  • each injection port of the injection unit be pumped.
  • the bag portion is inflated by inserting the intravaginal support device into the vagina and allowing fluid to flow into the bag portion of the balloon through the opening / closing portion. Accordingly, since the outer bag body that accommodates the bag portion can be inflated, the mutual positional relationship between the bag portion and the outer bag body, the shape and the expansion characteristics of the bag portion and the outer bag body (for example, By properly setting the direction of expansion, such as whether it can expand in all directions or only in a specific direction, and the size of elastic compliance, etc. It can be surely adapted to the shape of the vagina.
  • the injection part of the fluid injection device is connected to the vaginal internal support inserted into the vagina, or the vaginal internal support to which the injection part of the fluid injection device is connected is connected to the vagina. Since the fluid of the amount inserted and adjusted by the adjustment operation unit can be pumped to the injection port of the injection unit by the injection operation unit, the vaginal internal support can be expanded by an easy operation.
  • FIG. 4 is a partial longitudinal sectional view of the fluid injection device of FIG. 3.
  • FIG. 4 is a longitudinal sectional view showing a state where the fluid injection device of FIG. 3 is connected to the vaginal internal support of FIG. 1 and air is injected. It is a partial longitudinal cross-sectional view which shows the state which has arrange
  • FIG. 9 is a cross-sectional view taken along the line AA in FIG.
  • FIG. 7 is a modification of the vagina internal support of FIG. 7, Comprising:
  • One of the bag parts is comprised with the material with low elastic compliance, and the example arrange
  • FIG. 7 It is a perspective view which shows the other modification of the vagina internal support tool of FIG. 7, and shows the example which provided the hollow part. It is a perspective view which shows the further another modification of the vagina inside support tool of FIG. 7, (a) is the example which formed the convex part in the outer surface of a bag part, (b) is a protrusion on the outer surface of a bag part. Examples of arrangement are shown respectively. It is a perspective view which shows the further another modification of the vagina inner support tool of FIG. 7, (a) shows the example which uses a balloon-shaped balloon, (b) shows the example which has arrange
  • FIG. 7 shows the example using a ring-shaped balloon, (b) shows the example using a holding member, respectively. It is a perspective view which shows the further another modification of the vagina internal support tool of FIG. 7, and shows the example which provided the recessed part. It is a side view which shows the further another modification of the vagina internal support tool of FIG. 7, and shows the example which provided the groove part.
  • FIG. 1 is a perspective view of a vaginal internal support of this example, where (a) shows an expanded state and (b) shows a contracted state.
  • FIG. 2 is a longitudinal sectional view of the internal vagina support of this example, where (a) shows an expanded state and (b) shows a contracted state.
  • the vaginal internal support 1 includes a balloon 20, an outer bag body 30, and a ring body (pressing portion) 40.
  • the balloon 20 includes a mouth portion 21, an opening / closing portion 22 that is continuous with the mouth portion 21, and a bag portion 23 that is continuous with the opening / closing portion 22.
  • the mouth portion 21 is formed with a tapered surface 21 a that is inclined toward the bag portion 23 toward the center of the mouth portion 21.
  • the tapered surface 21a forms a connection portion to which an inlet of a fluid injection device described later is connected.
  • the opening / closing part 22 can be switched between an open state in which fluid, in this example, air is allowed to pass, and a shut-off state, in which the passage of fluid is blocked.
  • the opening / closing part 22 has a through hole 22a penetrating inside and outside of the bag part 23, and the opening on the bag part 23 side of the through hole 22a is sealed by a cantilevered check valve 22b. ing. Therefore, in the opening / closing part 22, the check valve 22b allows the inflow of air into the bag part 23, and the air outflow from the bag part 23 is blocked.
  • the bag portion 23 is made of an airtight elastic material, can be expanded by inflow of air through the opening / closing portion 22, and can be contracted by outflow of air through the opening / closing portion 22.
  • the outer bag 30 is made of an airtight elastic material.
  • the outer bag 21, the opening / closing part 22, and the bag part 23 of the balloon 20 are accommodated, and the bag part 23 is inflated and contracted. It can shrink.
  • a space S is formed between the inner surface of the outer bag body 30 and the outer surface of the bag portion 23 in a region opposite to the mouth portion 21. In other areas, the outer bag 30 and the balloon 20 are joined to each other.
  • the space S is filled with air, but instead of air, for example, a gas other than air, a liquid, or a fluid such as a viscous material can be filled.
  • the ring body 40 is provided on the outer bag body 30 so as to surround the opening / closing part 22.
  • the ring body 40 is integrated with the outer surface of the outer bag body 30 in a region surrounding the opening / closing part 22 by, for example, bonding. Therefore, by pressing the ring body 40 inward at a predetermined circumferential position, the check valve 22b can be deformed to open the through hole 22a, and the outflow of air from the bag portion 23 can be allowed.
  • FIG. 3 is a perspective view of the fluid injection device of this example.
  • FIG. 4 is a partial longitudinal sectional view of the fluid injection device of this example.
  • the fluid injection device 2 includes an injection unit 50, an adjustment operation unit 60, and an injection operation unit 70.
  • the injection part 50 is connected to the tapered surface 21a (connection part) of the vaginal internal support 1 described with reference to FIG. 2, and the injection port 51 communicating with the opening / closing part 22 is connected to the adjustment operation part 60.
  • a tube 52 provided continuously.
  • the adjustment operation unit 60 includes an inner cylinder 61, an inner pusher 62, and a knob 63.
  • the end of the tube 52 opposite to the inlet 51 of the tube 52 is screwed and fixed to the tip of the inner cylinder 61.
  • the tip of the inner pusher rod 62b is screwed into the inner gasket 62a, and the inner pusher flange 62c is integrally provided at the rear end of the inner pusher rod 62b.
  • the injection operation unit 70 includes an outer cylinder 71 that houses the inner cylinder 61 and the inner pusher 62, an outer pusher 72, and a cap 73.
  • a slit 71a is formed on the side wall to expose the knob 63 and a part of the side wall of the inner cylinder 61. From the slit 71a, the scale 61a displayed on the inner cylinder 61 is visible. Further, the inner cylinder 61 is made of a transparent material, and as a result, the position of the inner gasket 62a can be confirmed through the scale 61a.
  • the outer pusher 72 has a front end of the outer pusher rod 72b screwed into the outer gasket 72a, and an outer pusher flange 72c is integrally provided at the rear end of the outer pusher rod 72b. ing.
  • the cap 73 is screwed and fixed to the open end 71 b on the opposite side of the injection portion 50 of the outer cylinder 71.
  • the knob 63 of the adjustment operation unit 60 by operating the knob 63 of the adjustment operation unit 60 and adjusting the position of the inner gasket 62a to an appropriate scale position so that a desired amount of air determined by, for example, a doctor's examination is injected,
  • the amount of air sent to the injection port 51 of the injection unit 50 can be adjusted.
  • the outer pusher flange 72c of the injection operation unit 70 is pushed in, the inner pusher 62 is pushed in by the outer gasket 72a, and the amount of air adjusted by the adjustment operation unit 60 is pumped to the injection port 51 of the injection unit 50. can do.
  • the inlet 51 is connected to the tapered surface 21a (connecting portion) of the vagina internal support 1 and communicated with the opening / closing portion 22.
  • the amount of air adjusted by the adjusting operation portion is supplied to the inlet 51 by the injecting operation portion.
  • the check valve 22b of the opening / closing part 22 can be opened, air can flow into the bag part 23 of the balloon 20, and the bag part 23 can be inflated. Further, with the expansion of the bag portion 23, the space S between the inner surface of the outer bag body 30 and the outer surface of the bag portion 23 is pushed, and the outer bag body 30 in the region forming the space S is expanded. be able to.
  • vaginal internal support 1 that can be surely adapted to the shape of the patient's vagina.
  • the patient can use the finger or an insertion device, for example, with the vagina internal support 1 in a contracted state or a partially expanded state as shown in FIG. ),
  • the vaginal internal support 1 is inserted into the vagina, the injection part 50 of the fluid injection device 2 is inserted into the vagina and connected to the vaginal internal support 1, and as described above, the vaginal internal support 1 6 is removed, the injection part 50 of the fluid injection device 2 is removed from the vaginal internal support 1 and the fluid injection device 2 is taken out of the vagina, whereby the internal vaginal support 1 is removed from the vagina as shown in FIG. Can be placed in.
  • the injection 50 of the fluid injection device 2 are connected to the vaginal internal support 1, and the vaginal internal support 1, the injection part 50 of the fluid injection device 2, and the tube 52 are inserted into the vagina with fingers so that the vaginal internal support 1 is placed deep inside the vagina. You may make it insert in.
  • the bag part 23 of the vaginal internal support 1 is held in the vagina by being locked to the pubic tissue C via the outer bag body 30 and the anterior wall of the vagina.
  • the pubic tissue C means a hard tissue derived from the pubic bone, as described above with respect to the arrangement procedure of the conventional pessary.
  • the bag portion 23 is a region near the cervix N side of the pubic tissue C on the anterior vagina wall (that is, between the pubic tissue C and the cervix N).
  • the pressing force is applied to the region closer to the pubic tissue C than the cervix N), and the holding force of the vagina internal support 1 in the vagina is also strengthened from this point. Therefore, it is possible to support the cervix N from below by the vaginal internal support device 1 and / or suppress drooping of the anterior wall of the vagina and / or inhibit drooping of the posterior wall of the vagina and inhibit pelvic organ prolapse. It becomes.
  • the patient contracts the vagina internal support device 1 by squeezing the ring body 40 inward at a predetermined circumferential position with a finger, and causes the ring body 40 to contract. Just pull it out with your finger.
  • FIG. 7 is a perspective view showing the vagina internal support of the present example in an expanded state.
  • FIG. 8 is a longitudinal sectional view showing the vagina internal support of the present example in an expanded state.
  • 9 is a cross-sectional view taken along the line AA in FIG.
  • the intravaginal support 1 ′ includes three balloons in this example, that is, a first balloon 80 disposed on the vagina rear wall side, a first balloon 80 disposed on the vagina front wall side, and a vagina inlet side.
  • positioned in the vaginal front wall side and the back side of vagina, the outer bag body 30, and the ring body (pressing part) 40 are comprised.
  • each of the first balloon 80, the second balloon 80 ′, and the third balloon 80 ′′ has a small bag portion 83, 83 ′, 83 ′′, and the peripheral walls of the mouth portion are integrated with each other.
  • the structure is the same as that of the balloon 20 in the example described with reference to FIG.
  • the opening / closing portions 82, 82 ′, 82 ′′ of the first balloon 80, the second balloon 80 ′, and the third balloon 80 ′′ are symmetrical around the axis O of the ring body 40. Has been placed. Further, all of these check valves are cantilevered in the same direction (in this example, upward in FIGS. 8 and 9).
  • the outer bag body 30 stores all of the first balloon 80, the second balloon 80 ′, and the third balloon 80 ′′ in this example. It can be expanded and contracted with the expansion and contraction of 83 ′ and 83 ′′.
  • the ring body 40 has a ring shape surrounding each of the open / close portions 82, 82 ′, 82 ′′. 9 at the 3 o'clock and 9 o'clock positions), each check valve is deformed to allow fluid outflow from each bag portion.
  • FIG. 10 is a perspective view of the fluid injection device of this example.
  • the fluid injection device 2 ′ of this example corresponds to the three opening / closing portions 82, 82 ′, 82 ′′ of the vaginal internal support 1 ′ described with reference to FIGS. 3 is the same as the fluid injection device 2 described with reference to FIG. 3 and FIG.
  • the injection part 50 is connected to the connection part of each balloon of the vaginal internal support 1 ′, and the three injections communicating with the opening / closing parts 82, 82 ′, 82 ′′, respectively. It has inlets 51, 51 ', 51' '.
  • the injection unit 50 includes three inner tubes (not shown) that connect the respective injection ports 51, 51 ′, 51 ′′ to the corresponding adjustment operation units 60, 60 ′, 60 ′′, respectively. Have inside.
  • Each adjustment operation unit 60, 60 ′, 60 ′′ has the same configuration as that of the adjustment operation unit 60 in the example described with reference to FIGS. 3 and 4, and each knob 63, 63 ′, 63 ′. By manipulating ', the amount of fluid sent to each inlet 51, 51', 51 '' can be adjusted.
  • the injection operation unit 70 has the same configuration as the injection operation unit 70 in the example described with reference to FIGS. 3 and 4, and each adjustment is performed by an outer gasket (not shown) when the outer pusher flange 72c is pushed in.
  • Each of the inner pushers (not shown) of the operation units 60, 60 ′, 60 ′′ is pushed in, and the amount of air adjusted by each adjustment operation unit 60, 60 ′, 60 ′′ is respectively injected into the injection unit 50. Can be pumped to the respective inlets 51, 51 ′, 51 ′′.
  • the injection part 50 of the fluid injection device 2 ′ is connected to the tapered surface 21a (connection part) of the vaginal internal support 1 ′ to open and close the injection ports 51, 51 ′, 51 ′′. , 82, 82 ′, 82 ′′ are communicated with each of the adjustment operation units 60, 60 ′, 60 ′′.
  • Each check valve of each opening / closing part 82, 82 ′, 82 ′′ is opened by pressure feeding to 51 ′′, and air flows into the bag part of each balloon 80, 80 ′, 80 ′′.
  • the part can be inflated.
  • the bag portions of the second balloon 80 ′ and the third balloon 80 ′′ are pressed toward the vaginal front wall by the expansion of the bag portion of the first balloon 80 disposed on the vagina rear wall side. be able to.
  • the procedure for disposing the vagina internal support 1 ′ in this example in the vagina is the same as in the example described with reference to FIGS. 1 to 6, but in this example, a plurality of bags are provided. Nevertheless, it is possible to inject an adjusted amount of air into each bag part by a single operation of operating the injection operation part 70 of the fluid injection device 2 ′. Therefore, according to the fluid injection device 2 ′ of this example, the operation of inflating the vagina inner support 1 ′ can be greatly facilitated. Further, when removing the vaginal internal support 1 ′ from the vagina, air can be discharged from all the bag portions by a single operation of pressing the ring body 40 inward at a predetermined circumferential position. Therefore, according to the vaginal internal support 1 'of this example, the operation for removing the vaginal internal support 1' from the vagina can be greatly facilitated.
  • the vaginal internal support comprises two or more balloons, and at least one of the two or more balloons is made of a material in which a balloon bag is less elastic compliant than at least one other balloon bag.
  • the bag portion 83 of the first balloon 80 has lower elastic compliance than the bag portions 83 ′ and 83 ′′ of the second balloon 80 ′ and the third balloon 80 ′′. It can be made of material and placed on the vagina posterior wall side.
  • the vaginal internal support device includes two or more balloons, and by inflating both of the two or more balloons, a hollow portion that can fit the cervix is formed on the outer surface of the outer bag body.
  • the entire vagina internal support device can be inserted into the vagina while pushing the cervix hanging down at the depression.
  • the bag portion 83 of the first balloon 80 is partially surrounded by the bag portions 83 ′ and 83 ′′ of the second balloon 80 ′ and the third balloon 80 ′′, thereby forming the depression U. Can be formed.
  • a convex portion P is formed on the outer surface of the bag portion by forming a partial region of the bag portion with a material having high elastic compliance.
  • the protrusion Q is arranged on the outer surface of the bag portion, so that either the protrusion P or the protrusion Q is connected to the pubic tissue C shown in FIGS. 6 (a) and 6 (b).
  • the inner vaginal support can be securely held in the vagina by engaging the outer bag body with the outer bag body and the front wall of the vagina or by fitting the recess in the vagina wall with the outer bag body.
  • the intravaginal support device includes two or more balloons, and at least one of the two or more balloons has a balloon bag portion having an elongated shape than the other at least one balloon bag portion. Also good.
  • a balloon having a bellows-like bag portion 90 and two balloons having an elongated bag portion 91 are provided, and around two elongated bag portions 91 arranged in parallel.
  • it is configured such that a vine-shaped bag portion 90 is wound.
  • a plurality of convex portions can be formed on the surface of the vagina internal support, and any one of the plurality of convex portions is applied to the pubic tissue C shown in FIG.
  • the internal support for the vagina can be securely held in the vagina by being locked through the front wall or adapted to the recess in the vagina wall.
  • the elongate bag portion 92 is folded and stored in the outer bag body, so that the outer bag body expands in the vaginal front-rear direction (arrow direction in the figure) when inflated.
  • the outer bag body is easily locked to the pubic tissue C shown in FIG. 6 through the anterior vagina wall.
  • the intravaginal support device includes two or more balloons, and the two or more balloons are each made of a material having a lower elastic compliance than that of the balloon, such as an elastomer or plastic. It can also be set as the structure joined by the member R.
  • a recess W for a patient to hook a finger when removing the vagina inner support from the vagina can be provided on the outer surface of the vagina inner wall on the vagina rear wall side.
  • a groove T extending from the back of the vagina toward the vagina inlet side may be provided on the outer surface of the vagina internal support, and the vaginal secretion can be discharged through the groove T.
  • a through hole that penetrates the vagina internal support may be provided.
  • the outer bag body has been described as accommodating the mouth portion, the opening / closing portion, and the entire bag portion of the balloon.
  • the outer bag body is not necessarily limited to such a configuration, and the outer bag body may accommodate the balloon bag portion. That's fine.
  • the number of balloons provided in the vaginal internal support may be two, or four or more.

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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)
  • Surgical Instruments (AREA)

Abstract

This intravaginal support tool (1) comprises: a balloon (20) including an opening/closing part (22) that can be operated so as to be switched between an open state that lets a fluid pass through and a blocked state that blocks the passage of the fluid, and a bag part (23) that can be inflated by the inflow of the fluid through the opening/closing part (22) and that can be deflated by the outflow of the fluid through the opening/closing part (22); and an outer bag body (30) that houses the bag part (23) of the balloon (20), and that can be inflated/deflated along with the inflation/deflation of the bag part (23).

Description

膣内部支持具及び流体注入デバイスVaginal internal support and fluid injection device
　本発明は、骨盤臓器脱の治療に用いられる、膣内に挿入された状態で膨張収縮可能な膣内部支持具に関し、特に、患者の膣内形状に確実に適合させようとするものである。
　また、本発明は、前記膣内部支持具を膨張させるための流体注入デバイスに関し、特に、流体の注入操作を容易化しようとするものである。 The present invention relates to a vaginal internal support that can be used for the treatment of pelvic organ prolapse and that can be expanded and contracted while inserted into the vagina, and in particular, is intended to ensure conformity to the shape of the patient's vagina.
The present invention also relates to a fluid injection device for inflating the vaginal internal support, and particularly to facilitate fluid injection operation.
　近年、高齢化に伴い、骨盤臓器脱の患者数が増加している。骨盤臓器脱とは、骨盤の中にある子宮、膀胱、直腸などの臓器が下垂し、重症例では体外に脱出してしまう病気であり、強い不快感、排尿障害、排便困難、脱出部の痛みなどの症状を及ぼす。加齢に伴い、経膣出産者の４４％が発症し、国内の潜在患者数は３５０万人に上るとの報告もある。 In recent years, with the aging of the population, the number of patients with pelvic organ prolapse has increased. Pelvic organ prolapse is a disease in which the uterus, bladder, rectum, and other organs in the pelvis droop and escape from the body in severe cases. Such as symptoms. There are reports that 44% of vaginal births develop with aging and the number of potential patients in the country is 3.5 million.
　骨盤臓器脱の軽症患者には、骨盤底筋体操、ホルモン補充療法などの治療法や、クッションを用いた対処療法などが有効である。骨盤臓器脱の中等症患者及び重症患者には、症状や患者の希望により、メッシュ挿入術や外科的固定術といった手術療法の他、低侵襲な非手術療法として、ペッサリーを用いた治療が行われている。ペッサリーは、通常、弾性変形可能なリング体からなり、医師によって患者の膣内に挿入、配置されることによって、子宮頸部、膣前壁、及び膣後壁などの下垂を支えて骨盤臓器脱を抑制する。 For patients with mild pelvic prolapse, treatments such as pelvic floor muscle exercises, hormone replacement therapy, and coping therapy using cushions are effective. Patients with moderate or severe pelvic prolapse are treated with pessaries as a minimally invasive non-surgical treatment in addition to surgical treatments such as mesh insertion and surgical fixation, depending on the symptoms and the patient's wishes. ing. A pessary usually consists of an elastically deformable ring body, which is inserted and placed in the patient's vagina by a doctor to support the drooping of the cervix, the anterior wall of the vagina, the posterior wall of the vagina, etc. Suppress.
　最も一般的なペッサリーであるリングペッサリーでは、円形のリング体を楕円形に変形させた状態で膣内に挿入される。この挿入されたリング体が楕円形から円形に復元しつつ、この復元した円形のリング体の径方向が、膣入口から膣奥に向う方向に対して略垂直となる状態で、リング体の一部が、膣前壁における恥骨由来の固い組織（以下、「恥骨組織」という）の子宮頸部側近傍領域に押し当てられ、当該領域において、膣前壁を介して恥骨組織に係止されることにより、膣内に保持される。より具体的には、膣前壁を体内（尿道）側に押し込むと、周囲の柔らかい膣壁部分は押し込み変形可能であるのに対し、深部に恥骨組織が存在する領域では、恥骨組織に至る深度以上の押し込み変形は難しい。このため膣前壁における、深部に恥骨組織が存在する領域よりも少し膣奥側の領域（すなわち、前述した膣前壁における恥骨組織の子宮頸部側近傍領域）にペッサリーを押し当てると、押し込み変形可能な領域と、押し込み変形困難な領域とによって凹部が形成され、この凹部にペッサリーが係止する。この状態でペッサリーに対して膣奥から膣入口に向う方向へ力が加わった場合、ペッサリーには、恥骨組織から膣前壁を介して、膣入口から膣奥に向う方向への抗力が働くため、ペッサリーの離脱が抑制される。 In the ring pessary, which is the most common pessary, a circular ring body is inserted into the vagina with an elliptical shape. While the inserted ring body is restored from an elliptical shape to a circular shape, the radial direction of the restored circular ring body is substantially perpendicular to the direction from the vaginal entrance to the back of the vagina. Is pressed against a region near the cervix side of a hard tissue derived from the pubic bone (hereinafter referred to as “pubic tissue”) in the anterior vaginal wall, and is locked to the pubic tissue through the anterior vaginal wall in the region. Is held in the vagina. More specifically, when the anterior wall of the vagina is pushed into the body (urethra), the surrounding soft vagina wall can be pushed and deformed, whereas in areas where the pubic tissue is deep, the depth leading to the pubic tissue The above indentation deformation is difficult. For this reason, when the pessary is pressed against the region slightly behind the vagina than the region where the pubic tissue exists in the deep part of the vagina (that is, the region near the cervix side of the pubic tissue on the anterior vagina) A recess is formed by the deformable region and the region in which push-in deformation is difficult, and the pessary is locked in the recess. In this state, if force is applied to the pessary in the direction from the back of the vagina to the entrance of the vagina, the pessary has a drag in the direction from the vagina entrance to the back of the vagina through the anterior wall of the vagina. , Pessary withdrawal is suppressed.
　また、このようなペッサリーは、体内に長期間に配置したままにすると異臭を生じたり、圧迫箇所から出血を生じたりするため、定期的に、体内から除去し、洗浄したものを再度挿入、配置し、又は新品を挿入、配置する必要がある。しかしながら、ペッサリーは、リング体の外径が膣入口よりもかなり大きく、脱着が容易ではない。このため、ペッサリーに代るものとして、膣内で膨張収縮可能な膣内部支持具が提案されている。 In addition, such pessaries may cause off-flavors or bleeding from pressure points if left in the body for a long period of time. Or a new one needs to be inserted and placed. However, the pessary has a ring body whose outer diameter is considerably larger than that of the vaginal entrance, and is not easy to remove. For this reason, as an alternative to the pessary, a vaginal internal support that can expand and contract in the vagina has been proposed.
　例えば、特許文献１に記載される膣内部支持具は、膣入口側に配置されると共に弁を介して膨張収縮可能な袋体と、膣奥側に配置されると共に他の弁を介して膨張収縮可能な他の袋体とを備える。 For example, the vaginal internal support described in Patent Document 1 is disposed on the vaginal entrance side and is inflatable via the valve, and is disposed on the back side of the vagina and inflated via another valve. And other shrinkable bags.
米国特許第５６０３６８５号明細書US Pat. No. 5,603,685
　しかしながら、特許文献１に記載されるような膣内部支持具では、患者の膣内形状に確実に適合させることができるとは限らなかった。そのため、骨盤臓器脱の抑制効果が十分に得られないことや、圧迫箇所を生じ、出血やびらんなどの障害が発生することがあった。 However, the vaginal internal support device described in Patent Document 1 cannot always be surely adapted to the shape of the patient's vagina. For this reason, the effect of suppressing pelvic organ prolapse has not been sufficiently obtained, and a compression site has been produced, causing problems such as bleeding and erosion.
　本発明は、前記の現状に鑑み開発されたもので、患者の膣内形状に確実に適合させることのできる膣内部支持具を提供することを目的とする。
　また、本発明は、そのような膣内部支持具を膨張させるための、流体の注入操作の容易な流体注入デバイスを提供することを目的とする。 The present invention has been developed in view of the above-described present situation, and an object thereof is to provide an intravaginal support that can be surely adapted to the intravaginal shape of a patient.
It is another object of the present invention to provide a fluid injection device for inflating such a vaginal internal support, which can be easily injected with a fluid.
　本発明の膣内部支持具は、骨盤臓器脱の治療に用いられ、膣内に挿入された状態で膨張収縮可能な膣内部支持具において、流体を通過させる開放状態と流体の通過を遮断する遮断状態との間で切り換え動作可能な開閉部と、該開閉部を介した流体の流入によって膨張可能であると共に、前記開閉部を介した流体の流出によって収縮可能である袋部と、を有するバルーンと、前記バルーンの袋部を収納し、該袋部の膨張収縮に伴って膨張収縮可能な外袋体とを備えることを特徴とする。
　なお、流体とは、例えば、空気、その他の気体、液体又は粘性体などの流体を意味する。 INDUSTRIAL APPLICABILITY The intravaginal support device of the present invention is used for the treatment of pelvic organ prolapse, and in the intravaginal support device that can be inflated and contracted while inserted into the vagina, the open state where fluid is allowed to pass and the blocking of passage of fluid are blocked. A balloon having an opening / closing portion that can be switched between states, and a bag portion that is inflatable by inflow of fluid through the opening / closing portion and contractable by outflow of fluid through the opening / closing portion. And an outer bag body which accommodates the bag portion of the balloon and can be inflated and contracted as the bag portion expands and contracts.
In addition, fluid means fluids, such as air, other gas, a liquid, or a viscous body, for example.
　ここで、本発明の膣内部支持具は、前記バルーンを２つ以上備え、前記外袋体は、前記２つ以上のバルーンの袋部をいずれも収納し、該袋部の膨張収縮に伴って膨張収縮可能であることが好ましい。 Here, the vaginal internal support device of the present invention includes two or more balloons, and the outer bag body stores both of the bag portions of the two or more balloons, and the bag portions are expanded and contracted. It is preferable that it can expand and contract.
　また、本発明の膣内部支持具は、前記２つ以上のバルーンのうち少なくとも１つは、該バルーンの袋部の膨張によって、他のバルーンの袋部を膣前壁に向かって押圧することが好ましい。 In the vaginal internal support device of the present invention, at least one of the two or more balloons can press the bag portion of the other balloon toward the anterior wall of the vagina by the expansion of the bag portion of the balloon. preferable.
　また、本発明の膣内部支持具は、前記２つ以上のバルーンは、互いに異なる弾性コンプライアンスを有することが好ましい。
　なお、弾性コンプライアンスとは、弾性率の逆数であり、物体の変形しやすさを示す物理量である。 In the vaginal internal support device of the present invention, it is preferable that the two or more balloons have different elastic compliances.
The elastic compliance is the reciprocal of the elastic modulus and is a physical quantity indicating the ease of deformation of the object.
　また、本発明の膣内部支持具は、前記２つ以上のバルーンをいずれも膨張させることによって、外袋体の外表面に、子宮頸部に適合可能な窪み部が形成されることが好ましい。 In addition, in the vaginal internal support device of the present invention, it is preferable that a recess that can fit the cervix is formed on the outer surface of the outer bag body by inflating the two or more balloons.
　また、本発明の膣内部支持具は、前記１つ以上のバルーンの前記開閉部をいずれも取り囲むリング状の押圧部をさらに備え、各開閉部は、各袋部への流体の流入を許容するが、各袋部からの流体の流出は遮断する逆止弁をそれぞれ有し、前記逆止弁はいずれも、前記リング状の押圧部を所定の周方向位置で内側に圧迫することによって、各袋部からの流体の流出を許容することが好ましい。 The vaginal internal support device of the present invention further includes a ring-shaped pressing portion that surrounds all of the opening / closing portions of the one or more balloons, and each opening / closing portion allows fluid to flow into each bag portion. However, each of the check valves has a check valve for blocking outflow of fluid from each bag portion, and each of the check valves presses the ring-shaped pressing portion inward at a predetermined circumferential position. It is preferable to allow fluid outflow from the bag portion.
　また、本発明の膣内部支持具を膨張させるための流体注入デバイスは、前記膣内部支持具に接続し、前記開閉部に連通する注入口を有する注入部と、前記注入部の注入口に送る流体の量を調整可能な調整操作部と、前記調整操作部によって調整された量の流体を、前記注入部の注入口に圧送させる注入操作部とを備えることを特徴とする。 Further, the fluid injection device for inflating the vaginal internal support device of the present invention is connected to the vaginal internal support device and has an injection port having an injection port communicating with the opening and closing unit, and is sent to the injection port of the injection unit An adjustment operation unit capable of adjusting the amount of fluid, and an injection operation unit that pumps the amount of fluid adjusted by the adjustment operation unit to the injection port of the injection unit.
　また、本発明の流体注入デバイスは、前記注入部は、２つ以上の前記バルーンを備える前記膣内部支持具に接続し、前記２つ以上のバルーンの各開閉部にそれぞれ連通する２つ以上の注入口を有し、前記調整操作部は、前記注入部の各注入口に送る流体の量をそれぞれ調整可能であり、前記注入操作部は、前記調整操作部によって調整された量の流体をそれぞれ、前記注入部の各注入口に圧送させることが好ましい。 Further, in the fluid injection device of the present invention, the injection part is connected to the vaginal internal support device including two or more balloons, and the two or more communication parts communicate with the opening / closing parts of the two or more balloons. The adjustment operation unit can adjust the amount of fluid sent to each injection port of the injection unit, and the injection operation unit supplies the amount of fluid adjusted by the adjustment operation unit, respectively. In addition, it is preferable that each injection port of the injection unit be pumped.
　本発明に係る膣内部支持具によれば、膣内部支持具を膣内に挿入し、バルーンの袋部に流体を開閉部を介して流入させることによって袋部を膨張させ、当該袋部の膨張に伴って、当該袋部を収納する外袋体を膨張させることができるため、袋部と外袋体との互いの位置関係や、袋部及び外袋体それぞれの形状及び膨張特性（例えば、全方向に膨張可能とするか、特定の方向のみに膨張可能とするかといった膨張の指向性や、弾性コンプライアンスの大きさなど）などを適切に設定しておくことで、膣内部支持具を患者の膣内形状に確実に適合させることができる。 According to the intravaginal support device of the present invention, the bag portion is inflated by inserting the intravaginal support device into the vagina and allowing fluid to flow into the bag portion of the balloon through the opening / closing portion. Accordingly, since the outer bag body that accommodates the bag portion can be inflated, the mutual positional relationship between the bag portion and the outer bag body, the shape and the expansion characteristics of the bag portion and the outer bag body (for example, By properly setting the direction of expansion, such as whether it can expand in all directions or only in a specific direction, and the size of elastic compliance, etc. It can be surely adapted to the shape of the vagina.
　また、本発明に係る流体注入デバイスによれば、膣内に挿入した膣内部支持具に流体注入デバイスの注入部を接続し、又は、流体注入デバイスの注入部を接続した膣内部支持具を膣内に挿入し、調整操作部によって調整された量の流体を、注入操作部によって注入部の注入口に圧送させることができるため、容易な操作で膣内部支持具を膨張させることができる。 Further, according to the fluid injection device according to the present invention, the injection part of the fluid injection device is connected to the vaginal internal support inserted into the vagina, or the vaginal internal support to which the injection part of the fluid injection device is connected is connected to the vagina. Since the fluid of the amount inserted and adjusted by the adjustment operation unit can be pumped to the injection port of the injection unit by the injection operation unit, the vaginal internal support can be expanded by an easy operation.
本発明の一実施形態に係る膣内部支持具の斜視図であり、（ａ）は膨張した状態、（ｂ）は収縮した状態をそれぞれ示す。It is a perspective view of the vagina internal support which concerns on one Embodiment of this invention, (a) shows the expanded state, (b) shows the contracted state, respectively. 図１の膣内部支持具の縦断面図であり、（ａ）は膨張した状態、（ｂ）は収縮した状態をそれぞれ示す。It is a longitudinal cross-sectional view of the vagina internal support tool of FIG. 1, (a) shows the expanded state, (b) shows the contracted state. 本発明の一実施形態に係る流体注入デバイスの斜視図である。1 is a perspective view of a fluid injection device according to an embodiment of the present invention. 図３の流体注入デバイスの一部縦断面図である。FIG. 4 is a partial longitudinal sectional view of the fluid injection device of FIG. 3. 図１の膣内部支持具に図３の流体注入デバイスを接続し、空気を注入している状態を示す縦断面図である。FIG. 4 is a longitudinal sectional view showing a state where the fluid injection device of FIG. 3 is connected to the vaginal internal support of FIG. 1 and air is injected. 図１の膣内部支持具を膣内に配置した状態を示す一部縦断面図であり、（ａ）は膨張前、（ｂ）は膨張後の状態を示す。It is a partial longitudinal cross-sectional view which shows the state which has arrange | positioned the vagina internal support tool of FIG. 1 in the vagina, (a) shows the state after expansion, (b) shows the state after expansion. 本発明の他の実施形態に係る膣内部支持具を膨張した状態で示す斜視図である。It is a perspective view which shows the vagina internal support which concerns on other embodiment of this invention in the expanded state. 図７の膣内部支持具を膨張した状態で示す縦断面図である。It is a longitudinal cross-sectional view shown in the state which expanded the vagina internal support tool of FIG. 図８のＡ－Ａ断面図である。FIG. 9 is a cross-sectional view taken along the line AA in FIG. 本発明の他の実施形態に係る流体注入デバイスの斜視図である。It is a perspective view of the fluid injection | pouring device which concerns on other embodiment of this invention. 図７の膣内部支持具の変形例であって、袋部の一つを弾性コンプライアンスの低い材料で構成し、膣後壁側に配置した例を示し、（ａ）は斜視図、（ｂ）は横断面図である。It is a modification of the vagina internal support of FIG. 7, Comprising: One of the bag parts is comprised with the material with low elastic compliance, and the example arrange | positioned in the vagina rear wall side is shown, (a) is a perspective view, (b) Is a cross-sectional view. 図７の膣内部支持具の他の変形例を示す斜視図であり、窪み部を設けた例を示す。It is a perspective view which shows the other modification of the vagina internal support tool of FIG. 7, and shows the example which provided the hollow part. 図７の膣内部支持具のさらなる他の変形例を示す斜視図であり、（ａ）は袋部の外表面に凸部を形成した例、（ｂ）は袋部の外表面に突起体を配置した例をそれぞれ示す。It is a perspective view which shows the further another modification of the vagina inside support tool of FIG. 7, (a) is the example which formed the convex part in the outer surface of a bag part, (b) is a protrusion on the outer surface of a bag part. Examples of arrangement are shown respectively. 図７の膣内部支持具のさらなる他の変形例を示す斜視図であり、（ａ）は蔓巻状のバルーンを用いる例、（ｂ）は細長いバルーンを折畳んで配置した例をそれぞれ示す。It is a perspective view which shows the further another modification of the vagina inner support tool of FIG. 7, (a) shows the example which uses a balloon-shaped balloon, (b) shows the example which has arrange | positioned the elongate balloon by folding, respectively. 図７の膣内部支持具のさらなる他の変形例を示す斜視図であり、（ａ）はリング状のバルーンを用いる例、（ｂ）は保持部材を用いる例をそれぞれ示す。It is a perspective view which shows the further another modification of the vagina internal support tool of FIG. 7, (a) shows the example using a ring-shaped balloon, (b) shows the example using a holding member, respectively. 図７の膣内部支持具のさらなる他の変形例を示す斜視図であり、凹み部を設けた例を示す。It is a perspective view which shows the further another modification of the vagina internal support tool of FIG. 7, and shows the example which provided the recessed part. 図７の膣内部支持具のさらなる他の変形例を示す側面図であり、溝部を設けた例を示す。It is a side view which shows the further another modification of the vagina internal support tool of FIG. 7, and shows the example which provided the groove part.
　以下、本発明の実施形態について、図面を参照して説明する。
　まず、本発明の一実施形態に係る膣内部支持具について、図１～図２を参照して例示説明する。図１は、本例の膣内部支持具の斜視図であり、（ａ）は膨張した状態、（ｂ）は収縮した状態をそれぞれ示す。図２は、本例の膣内部支持具の縦断面図であり、（ａ）は膨張した状態、（ｂ）は収縮した状態をそれぞれ示す。 Hereinafter, embodiments of the present invention will be described with reference to the drawings.
First, an intravaginal support device according to an embodiment of the present invention will be described with reference to FIGS. FIG. 1 is a perspective view of a vaginal internal support of this example, where (a) shows an expanded state and (b) shows a contracted state. FIG. 2 is a longitudinal sectional view of the internal vagina support of this example, where (a) shows an expanded state and (b) shows a contracted state.
　図１に示すように、膣内部支持具１は、バルーン２０と、外袋体３０と、リング体（押圧部）４０とからなる。バルーン２０は、図２に示すように、口部２１と、口部２１に連なる開閉部２２と、開閉部２２に連なる袋部２３とを有する。口部２１には、口部２１の中心に向かって袋部２３側に傾斜するテーパ面２１ａが形成されている。テーパ面２１ａは、後述する流体注入デバイスの注入口が接続される接続部を形成している。 As shown in FIG. 1, the vaginal internal support 1 includes a balloon 20, an outer bag body 30, and a ring body (pressing portion) 40. As illustrated in FIG. 2, the balloon 20 includes a mouth portion 21, an opening / closing portion 22 that is continuous with the mouth portion 21, and a bag portion 23 that is continuous with the opening / closing portion 22. The mouth portion 21 is formed with a tapered surface 21 a that is inclined toward the bag portion 23 toward the center of the mouth portion 21. The tapered surface 21a forms a connection portion to which an inlet of a fluid injection device described later is connected.
　開閉部２２は、流体、本例では空気を通過させる開放状態と流体の通過を遮断する遮断状態との間で切り換え動作可能になっている。具体的には開閉部２２は、袋部２３の内外に貫通する貫通孔２２ａを有し、この貫通孔２２ａの袋部２３側の開口を、片持ち支持された逆止弁２２ｂで封止されている。したがって、開閉部２２は、逆止弁２２ｂにより、袋部２３への空気の流入は許容され、袋部２３からの空気の流出は遮断されている。袋部２３は、気密性の弾性材料からなり、開閉部２２を介した空気の流入によって膨張可能であると共に、開閉部２２を介した空気の流出によって収縮可能である。 The opening / closing part 22 can be switched between an open state in which fluid, in this example, air is allowed to pass, and a shut-off state, in which the passage of fluid is blocked. Specifically, the opening / closing part 22 has a through hole 22a penetrating inside and outside of the bag part 23, and the opening on the bag part 23 side of the through hole 22a is sealed by a cantilevered check valve 22b. ing. Therefore, in the opening / closing part 22, the check valve 22b allows the inflow of air into the bag part 23, and the air outflow from the bag part 23 is blocked. The bag portion 23 is made of an airtight elastic material, can be expanded by inflow of air through the opening / closing portion 22, and can be contracted by outflow of air through the opening / closing portion 22.
　外袋体３０は、気密性の弾性材料からなり、本例では、バルーン２０の口部２１、開閉部２２及び袋部２３の全体を収納しており、袋部２３の膨張収縮に伴って膨張収縮可能である。また、外袋体３０の内表面と袋部２３の外表面との間には、口部２１の反対側の領域で、空間Ｓが形成されている。その他の領域では、外袋体３０とバルーン２０とは互いに接合されている。空間Ｓには、本例では空気が充填されているが、空気に代えて、例えば、空気以外の気体、液体又は粘性体などの流体を充填することも可能である。 The outer bag 30 is made of an airtight elastic material. In this example, the outer bag 21, the opening / closing part 22, and the bag part 23 of the balloon 20 are accommodated, and the bag part 23 is inflated and contracted. It can shrink. A space S is formed between the inner surface of the outer bag body 30 and the outer surface of the bag portion 23 in a region opposite to the mouth portion 21. In other areas, the outer bag 30 and the balloon 20 are joined to each other. In this example, the space S is filled with air, but instead of air, for example, a gas other than air, a liquid, or a fluid such as a viscous material can be filled.
　リング体４０は、開閉部２２を取り囲むように、本例では外袋体３０に設けられている。具体的にはリング体４０は、開閉部２２を取り囲む領域における外袋体３０の外表面に、例えば接合などによって一体化されている。したがって、リング体４０を所定の周方向位置で内側に圧迫することによって、逆止弁２２ｂを変形させて貫通孔２２ａを開放し、袋部２３からの空気の流出を許容することができる。 In this example, the ring body 40 is provided on the outer bag body 30 so as to surround the opening / closing part 22. Specifically, the ring body 40 is integrated with the outer surface of the outer bag body 30 in a region surrounding the opening / closing part 22 by, for example, bonding. Therefore, by pressing the ring body 40 inward at a predetermined circumferential position, the check valve 22b can be deformed to open the through hole 22a, and the outflow of air from the bag portion 23 can be allowed.
　次に、本発明の一実施形態に係る流体注入デバイスについて、図３～図４を参照して例示説明する。図３は、本例の流体注入デバイスの斜視図である。図４は、本例の流体注入デバイスの一部縦断面図である。 Next, a fluid injection device according to an embodiment of the present invention will be described with reference to FIGS. FIG. 3 is a perspective view of the fluid injection device of this example. FIG. 4 is a partial longitudinal sectional view of the fluid injection device of this example.
　図３に示すように、流体注入デバイス２は、注入部５０と、調整操作部６０と、注入操作部７０とからなる。注入部５０は、前掲図２を用いて説明した膣内部支持具１のテーパ面２１ａ（接続部）に接続し、開閉部２２に連通する注入口５１と、注入口５１を調整操作部６０に連設するチューブ５２とを有している。図４に示すように、調整操作部６０は、内筒６１と、内押子６２と、摘み６３とからなっている。内筒６１の先端には、チューブ５２の注入口５１の反対側の端部がねじ込み固定されている。内押子６２は、内ガスケット６２ａに内押子ロッド６２ｂの先端がねじ込まれ、内押子ロッド６２ｂの後端に内押子フランジ６２ｃが一体に設けられている。 As shown in FIG. 3, the fluid injection device 2 includes an injection unit 50, an adjustment operation unit 60, and an injection operation unit 70. The injection part 50 is connected to the tapered surface 21a (connection part) of the vaginal internal support 1 described with reference to FIG. 2, and the injection port 51 communicating with the opening / closing part 22 is connected to the adjustment operation part 60. And a tube 52 provided continuously. As shown in FIG. 4, the adjustment operation unit 60 includes an inner cylinder 61, an inner pusher 62, and a knob 63. The end of the tube 52 opposite to the inlet 51 of the tube 52 is screwed and fixed to the tip of the inner cylinder 61. In the inner pusher 62, the tip of the inner pusher rod 62b is screwed into the inner gasket 62a, and the inner pusher flange 62c is integrally provided at the rear end of the inner pusher rod 62b.
　注入操作部７０は、内筒６１及び内押子６２を収容する外筒７１と、外押子７２と、キャップ７３とからなっている。外筒７１には、側壁に、摘み６３と内筒６１の側壁の一部とを露出するスリット７１ａが形成されている。スリット７１ａからは、内筒６１に表示された目盛６１ａを視認可能になっている。また、内筒６１は透明な素材からなっており、その結果、内ガスケット６２ａの位置を目盛６１ａを通じて確認できるようになっている。外押子７２は、内押子６２の場合と同様に、外ガスケット７２ａに外押子ロッド７２ｂの先端がねじ込まれ、外押子ロッド７２ｂの後端に外押子フランジ７２ｃが一体に設けられている。キャップ７３は、外筒７１の注入部５０の反対側の開放端部７１ｂにねじ込み固定されている。 The injection operation unit 70 includes an outer cylinder 71 that houses the inner cylinder 61 and the inner pusher 62, an outer pusher 72, and a cap 73. In the outer cylinder 71, a slit 71a is formed on the side wall to expose the knob 63 and a part of the side wall of the inner cylinder 61. From the slit 71a, the scale 61a displayed on the inner cylinder 61 is visible. Further, the inner cylinder 61 is made of a transparent material, and as a result, the position of the inner gasket 62a can be confirmed through the scale 61a. As in the case of the inner pusher 62, the outer pusher 72 has a front end of the outer pusher rod 72b screwed into the outer gasket 72a, and an outer pusher flange 72c is integrally provided at the rear end of the outer pusher rod 72b. ing. The cap 73 is screwed and fixed to the open end 71 b on the opposite side of the injection portion 50 of the outer cylinder 71.
　したがって、調整操作部６０の摘み６３を操作して、例えば医師の診察により決定された、所望の量の空気が注入されるように、内ガスケット６２ａの位置を適切な目盛位置に合せることにより、注入部５０の注入口５１に送る空気の量を調整することができる。そして、注入操作部７０の外押子フランジ７２ｃを押し込めば、外ガスケット７２ａで内押子６２を押し込んで、調整操作部６０によって調整された量の空気を、注入部５０の注入口５１に圧送することができる。 Therefore, by operating the knob 63 of the adjustment operation unit 60 and adjusting the position of the inner gasket 62a to an appropriate scale position so that a desired amount of air determined by, for example, a doctor's examination is injected, The amount of air sent to the injection port 51 of the injection unit 50 can be adjusted. When the outer pusher flange 72c of the injection operation unit 70 is pushed in, the inner pusher 62 is pushed in by the outer gasket 72a, and the amount of air adjusted by the adjustment operation unit 60 is pumped to the injection port 51 of the injection unit 50. can do.
　以上説明した本発明の一実施形態に係る膣内部支持具及び本発明の一実施形態に係る流体注入デバイスの構成によれば、図５に示すように、流体注入デバイス２の注入部５０の注入口５１を、膣内部支持具１のテーパ面２１ａ（接続部）に接続して開閉部２２に連通させ、調整操作部で調整しておいた量の空気を、注入操作部によって注入口５１に圧送することにより、開閉部２２の逆止弁２２ｂを開き、空気をバルーン２０の袋部２３に流入させ、袋部２３を膨張させることができる。また、この袋部２３の膨張に伴って、外袋体３０の内表面と袋部２３の外表面との間の空間Ｓが押され、空間Ｓを形成する領域の外袋体３０を膨張させることができる。 According to the configuration of the intravaginal support device according to the embodiment of the present invention described above and the fluid injection device according to the embodiment of the present invention, as shown in FIG. The inlet 51 is connected to the tapered surface 21a (connecting portion) of the vagina internal support 1 and communicated with the opening / closing portion 22. The amount of air adjusted by the adjusting operation portion is supplied to the inlet 51 by the injecting operation portion. By feeding by pressure, the check valve 22b of the opening / closing part 22 can be opened, air can flow into the bag part 23 of the balloon 20, and the bag part 23 can be inflated. Further, with the expansion of the bag portion 23, the space S between the inner surface of the outer bag body 30 and the outer surface of the bag portion 23 is pushed, and the outer bag body 30 in the region forming the space S is expanded. be able to.
　そして、袋部２３と外袋体３０との互いの位置関係や、袋部２３及び外袋体３０それぞれの形状や膨張特性、空間Ｓに封入する物質などを適切に設定しておくことで、患者の膣内形状に確実に適合させることができる膣内部支持具１を得ることが可能となる。 And by appropriately setting the mutual positional relationship between the bag portion 23 and the outer bag body 30, the shape and expansion characteristics of the bag portion 23 and the outer bag body 30, the substance enclosed in the space S, etc. It is possible to obtain the vaginal internal support 1 that can be surely adapted to the shape of the patient's vagina.
　このような膣内部支持具１及び流体注入デバイス２によれば、患者は、膣内部支持具１を収縮させた状態又はある程度膨張させた状態で、例えば指や挿入用器具で、図６（ａ）に示すように膣内部支持具１を膣内へ挿入し、流体注入デバイス２の注入部５０を膣内へ挿入して膣内部支持具１に接続し、前述したように膣内部支持具１を膨張させ、膣内部支持具１から流体注入デバイス２の注入部５０を取り外し、流体注入デバイス２を膣外へ取り出すことにより、図６（ｂ）に示すように、膣内部支持具１を膣内に配置することができる。 According to the vaginal internal support 1 and the fluid infusion device 2, the patient can use the finger or an insertion device, for example, with the vagina internal support 1 in a contracted state or a partially expanded state as shown in FIG. ), The vaginal internal support 1 is inserted into the vagina, the injection part 50 of the fluid injection device 2 is inserted into the vagina and connected to the vaginal internal support 1, and as described above, the vaginal internal support 1 6 is removed, the injection part 50 of the fluid injection device 2 is removed from the vaginal internal support 1 and the fluid injection device 2 is taken out of the vagina, whereby the internal vaginal support 1 is removed from the vagina as shown in FIG. Can be placed in.
　なお、膣内部支持具１を膣内へ挿入してから、流体注入デバイス２の注入部５０を膣内へ挿入して膣内部支持具１に接続する代わりに、流体注入デバイス２の注入部５０を膣内部支持具１に接続した状態で、膣内部支持具１、流体注入デバイス２の注入部５０、及びチューブ５２を、膣内部支持具１が膣奥へ配置されるように指で膣内に挿入するようにしてもよい。 Instead of inserting the vaginal internal support 1 into the vagina and then inserting the injection 50 of the fluid injection device 2 into the vagina and connecting it to the vaginal internal support 1, the injection 50 of the fluid injection device 2 Are connected to the vaginal internal support 1, and the vaginal internal support 1, the injection part 50 of the fluid injection device 2, and the tube 52 are inserted into the vagina with fingers so that the vaginal internal support 1 is placed deep inside the vagina. You may make it insert in.
　その結果、膣内部支持具１は、袋部２３が、外袋体３０及び膣前壁を介して恥骨組織Ｃに係止され、膣内に保持される。なお、恥骨組織Ｃとは、従来のペッサリーの配置要領に関して前述したとおり、恥骨由来の固い組織を意味する。また、外袋体３０と袋部２３との間の空間Ｓにより、袋部２３は膣前壁における恥骨組織Ｃの子宮頸部Ｎ側近傍領域（すなわち、恥骨組織Ｃと子宮頸部Ｎとの間の領域のうち、子宮頸部Ｎよりも恥骨組織Ｃに近い領域）に押し付けられるため、この点からも膣内部支持具１の膣内への保持力は強められる。したがって、膣内部支持具１によって子宮頸部Ｎを下から支え、及び/又は膣前壁の下垂を抑制し、及び/又は膣後壁の下垂を抑制し、骨盤臓器脱を抑制することが可能となる。 As a result, the bag part 23 of the vaginal internal support 1 is held in the vagina by being locked to the pubic tissue C via the outer bag body 30 and the anterior wall of the vagina. The pubic tissue C means a hard tissue derived from the pubic bone, as described above with respect to the arrangement procedure of the conventional pessary. Further, due to the space S between the outer bag body 30 and the bag portion 23, the bag portion 23 is a region near the cervix N side of the pubic tissue C on the anterior vagina wall (that is, between the pubic tissue C and the cervix N). In this region, the pressing force is applied to the region closer to the pubic tissue C than the cervix N), and the holding force of the vagina internal support 1 in the vagina is also strengthened from this point. Therefore, it is possible to support the cervix N from below by the vaginal internal support device 1 and / or suppress drooping of the anterior wall of the vagina and / or inhibit drooping of the posterior wall of the vagina and inhibit pelvic organ prolapse. It becomes.
　また、膣内部支持具１を膣内から取り出す際には、患者は、指でリング体４０を所定の周方向位置で内側に圧迫することにより膣内部支持具１を収縮させ、リング体４０に指を引っ掛けて引き出せばよい。 Further, when the vagina internal support device 1 is taken out from the vagina, the patient contracts the vagina internal support device 1 by squeezing the ring body 40 inward at a predetermined circumferential position with a finger, and causes the ring body 40 to contract. Just pull it out with your finger.
　次に、本発明の他の実施形態に係る膣内部支持具について、図７～図９を参照して例示説明する。図７は、本例の膣内部支持具を膨張した状態で示す斜視図である。図８は、本例の膣内部支持具を膨張した状態で示す縦断面図である。図９は、図８のＡ－Ａ断面図である。 Next, a vaginal internal support according to another embodiment of the present invention will be described with reference to FIGS. FIG. 7 is a perspective view showing the vagina internal support of the present example in an expanded state. FIG. 8 is a longitudinal sectional view showing the vagina internal support of the present example in an expanded state. 9 is a cross-sectional view taken along the line AA in FIG.
　図７に示すように、膣内部支持具１’は、本例では３つのバルーン、すなわち、膣後壁側に配置された第１バルーン８０、膣前壁側且つ膣入口側に配置された第２バルーン８０’、及び膣前壁側且つ膣奥側に配置された第３バルーン８０’’と、外袋体３０と、リング体（押圧部）４０とからなる。 As shown in FIG. 7, the intravaginal support 1 ′ includes three balloons in this example, that is, a first balloon 80 disposed on the vagina rear wall side, a first balloon 80 disposed on the vagina front wall side, and a vagina inlet side. 2 balloon 80 ', 3rd balloon 80' 'arrange | positioned in the vaginal front wall side and the back side of vagina, the outer bag body 30, and the ring body (pressing part) 40 are comprised.
　図８に示すように、第１バルーン８０、第２バルーン８０’及び第３バルーン８０’’はそれぞれ、袋部８３，８３’，８３’’が小さく、口部の周壁が互いに一体化されている他は、前掲図２を用いて説明した例におけるバルーン２０の場合と同一の構造になっている。 As shown in FIG. 8, each of the first balloon 80, the second balloon 80 ′, and the third balloon 80 ″ has a small bag portion 83, 83 ′, 83 ″, and the peripheral walls of the mouth portion are integrated with each other. Other than that, the structure is the same as that of the balloon 20 in the example described with reference to FIG.
　第１バルーン８０、第２バルーン８０’及び第３バルーン８０’’のそれぞれの開閉部８２，８２’，８２’’は、図９に示すように、リング体４０の軸線Ｏの周りに対称に配置されている。また、それらの逆止弁はいずれも、互いに同一の向き（本例では、図８及び図９における上方）で片持ち支持されている。 As shown in FIG. 9, the opening / closing portions 82, 82 ′, 82 ″ of the first balloon 80, the second balloon 80 ′, and the third balloon 80 ″ are symmetrical around the axis O of the ring body 40. Has been placed. Further, all of these check valves are cantilevered in the same direction (in this example, upward in FIGS. 8 and 9).
　外袋体３０は、図７に示したように、本例では、第１バルーン８０、第２バルーン８０’及び第３バルーン８０’’をいずれも収納しており、これらバルーンの袋部８３，８３’，８３’’の膨張収縮に伴って膨張収縮可能である。 As shown in FIG. 7, the outer bag body 30 stores all of the first balloon 80, the second balloon 80 ′, and the third balloon 80 ″ in this example. It can be expanded and contracted with the expansion and contraction of 83 ′ and 83 ″.
　リング体４０は、図９に示したように、各開閉部８２，８２’，８２’’をいずれも取り囲むリング状を成しており、リング体４０を所定の周方向位置（本例では図９における３時と９時の位置）で内側に圧迫することによって、各逆止弁が変形し、各袋部からの流体の流出を許容するようになっている。 As shown in FIG. 9, the ring body 40 has a ring shape surrounding each of the open / close portions 82, 82 ′, 82 ″. 9 at the 3 o'clock and 9 o'clock positions), each check valve is deformed to allow fluid outflow from each bag portion.
　次に、本発明の他の実施形態に係る流体注入デバイスについて、図１０を参照して例示説明する。図１０は、本例の流体注入デバイスの斜視図である。
　本例の流体注入デバイス２’は、前掲図７～図９を用いて説明した膣内部支持具１’の３つの開閉部８２，８２’，８２’’に対応して、注入口及び調整部を３組備えたこと以外は、前掲図３及び図４を用いて説明した流体注入デバイス２と同一の構成になっている。 Next, a fluid injection device according to another embodiment of the present invention will be described with reference to FIG. FIG. 10 is a perspective view of the fluid injection device of this example.
The fluid injection device 2 ′ of this example corresponds to the three opening / closing portions 82, 82 ′, 82 ″ of the vaginal internal support 1 ′ described with reference to FIGS. 3 is the same as the fluid injection device 2 described with reference to FIG. 3 and FIG.
　具体的には、注入部５０は、膣内部支持具１’の各バルーンの接続部にそれぞれ接続するようになっており、各開閉部８２，８２’，８２’’にそれぞれ連通する３つの注入口５１，５１’，５１’’を有する。また、注入部５０は、各注入口５１，５１’，５１’’をそれぞれ、対応する調整操作部６０，６０’，６０’’に連設する３つの内チューブ（図示省略）を外チューブ５３の内部に有している。 Specifically, the injection part 50 is connected to the connection part of each balloon of the vaginal internal support 1 ′, and the three injections communicating with the opening / closing parts 82, 82 ′, 82 ″, respectively. It has inlets 51, 51 ', 51' '. In addition, the injection unit 50 includes three inner tubes (not shown) that connect the respective injection ports 51, 51 ′, 51 ″ to the corresponding adjustment operation units 60, 60 ′, 60 ″, respectively. Have inside.
　各調整操作部６０，６０’，６０’’はそれぞれ、前掲図３及び図４を用いて説明した例における調整操作部６０と同一の構成になっており、各摘み６３，６３’，６３’’を操作することで、各注入口５１，５１’，５１’’に送る流体の量をそれぞれ調節可能である。 Each adjustment operation unit 60, 60 ′, 60 ″ has the same configuration as that of the adjustment operation unit 60 in the example described with reference to FIGS. 3 and 4, and each knob 63, 63 ′, 63 ′. By manipulating ', the amount of fluid sent to each inlet 51, 51', 51 '' can be adjusted.
　注入操作部７０は、前掲図３及び図４を用いて説明した例における注入操作部７０と同一の構成になっており、外押子フランジ７２ｃを押し込めば、外ガスケット（図示省略）で各調整操作部６０，６０’，６０’’の各内押子（図示省略）をいずれも押し込んで、各調整操作部６０，６０’，６０’’によって調整された量の空気をそれぞれ、注入部５０の各注入口５１，５１’，５１’’に圧送することができる。 The injection operation unit 70 has the same configuration as the injection operation unit 70 in the example described with reference to FIGS. 3 and 4, and each adjustment is performed by an outer gasket (not shown) when the outer pusher flange 72c is pushed in. Each of the inner pushers (not shown) of the operation units 60, 60 ′, 60 ″ is pushed in, and the amount of air adjusted by each adjustment operation unit 60, 60 ′, 60 ″ is respectively injected into the injection unit 50. Can be pumped to the respective inlets 51, 51 ′, 51 ″.
　以上説明した本発明の他の実施形態に係る膣内部支持具１’及び本発明の他の実施形態に係る流体注入デバイス２’の構成によれば、前掲図１～図６を用いて説明した例の場合と同様に、流体注入デバイス２’の注入部５０を、膣内部支持具１’のテーパ面２１ａ（接続部）に接続して各注入口５１，５１’，５１’’を各開閉部８２，８２’，８２’’に連通させ、各調整操作部６０，６０’，６０’’でそれぞれ調整しておいた量の空気を、注入操作部７０によって各注入口５１，５１’，５１’’にそれぞれ圧送することにより、各開閉部８２，８２’，８２’’の各逆止弁を開き、空気を各バルーン８０，８０’，８０’’の袋部に流入させ、各袋部を膨張させることができる。その際、本例では、膣後壁側に配置された第１バルーン８０の袋部の膨張によって、第２バルーン８０’及び第３バルーン８０’’の袋部を膣前壁に向かって押圧することができる。 According to the configurations of the vaginal internal support 1 ′ according to the other embodiment of the present invention and the fluid injection device 2 ′ according to the other embodiment of the present invention described above, it has been described with reference to FIGS. As in the case of the example, the injection part 50 of the fluid injection device 2 ′ is connected to the tapered surface 21a (connection part) of the vaginal internal support 1 ′ to open and close the injection ports 51, 51 ′, 51 ″. , 82, 82 ′, 82 ″ are communicated with each of the adjustment operation units 60, 60 ′, 60 ″. Each check valve of each opening / closing part 82, 82 ′, 82 ″ is opened by pressure feeding to 51 ″, and air flows into the bag part of each balloon 80, 80 ′, 80 ″. The part can be inflated. At this time, in this example, the bag portions of the second balloon 80 ′ and the third balloon 80 ″ are pressed toward the vaginal front wall by the expansion of the bag portion of the first balloon 80 disposed on the vagina rear wall side. be able to.
　そして、本例では、各袋部の互いの位置関係や、それぞれの形状、それぞれの膨張特性などを適切に設定しておくことで、患者の膣内形状に確実に適合させることができる膣内部支持具を得ることができる。 And in this example, by properly setting the positional relationship of each bag part, each shape, each expansion characteristic, etc., the inside of the vagina that can be surely adapted to the shape of the patient's vagina A support can be obtained.
　本例の膣内部支持具１’の膣内への配置要領は、前掲図１～図６を用いて説明した例の場合と同様であるが、本例では、袋部が複数備わっているにも関わらず、流体注入デバイス２’の注入操作部７０を操作するという、一度の操作で各袋部にそれぞれ調整された量の空気を注入することができる。したがって、本例の流体注入デバイス２’によれば、膣内部支持具１’を膨張させる操作を大幅に容易化することができる。また、膣内部支持具１’を膣内から取り除く際には、リング体４０を所定の周方向位置で内側に圧迫するという、一度の操作で全ての袋部から空気を排出することができる。したがって、本例の膣内部支持具１’によれば、膣内部支持具１’を膣内から取り除く際の操作を大幅に容易化することができる。 The procedure for disposing the vagina internal support 1 ′ in this example in the vagina is the same as in the example described with reference to FIGS. 1 to 6, but in this example, a plurality of bags are provided. Nevertheless, it is possible to inject an adjusted amount of air into each bag part by a single operation of operating the injection operation part 70 of the fluid injection device 2 ′. Therefore, according to the fluid injection device 2 ′ of this example, the operation of inflating the vagina inner support 1 ′ can be greatly facilitated. Further, when removing the vaginal internal support 1 ′ from the vagina, air can be discharged from all the bag portions by a single operation of pressing the ring body 40 inward at a predetermined circumferential position. Therefore, according to the vaginal internal support 1 'of this example, the operation for removing the vaginal internal support 1' from the vagina can be greatly facilitated.
　また、図７～図９を用いて説明した膣内部支持具に代えて、様々な変形例を採用することができる。
　例えば、膣内部支持具が２つ以上のバルーンを備え、２つ以上のバルーンのうち少なくとも１つは、バルーンの袋部が、他の少なくとも１つのバルーンの袋部より弾性コンプライアンスの低い材料からなると共に、膣後壁側に配置されているように構成することで、直腸の圧迫を緩和し、膣内部支持具の使用に伴い生じる排便障害を軽減、もしくは回避することができる。具体的には、図１１に示すように、例えば、第１バルーン８０の袋部８３を、第２バルーン８０’及び第３バルーン８０’’の袋部８３’，８３’’より弾性コンプライアンスの低い材料で形成すると共に、膣後壁側に配置することができる。 Further, various modified examples can be employed in place of the vaginal internal support described with reference to FIGS.
For example, the vaginal internal support comprises two or more balloons, and at least one of the two or more balloons is made of a material in which a balloon bag is less elastic compliant than at least one other balloon bag. At the same time, by being arranged on the posterior wall side of the vagina, it is possible to relieve pressure on the rectum and to reduce or avoid defecation disorders caused by the use of the vaginal internal support. Specifically, as shown in FIG. 11, for example, the bag portion 83 of the first balloon 80 has lower elastic compliance than the bag portions 83 ′ and 83 ″ of the second balloon 80 ′ and the third balloon 80 ″. It can be made of material and placed on the vagina posterior wall side.
　また、膣内部支持具が２つ以上のバルーンを備え、２つ以上のバルーンをいずれも膨張させることによって、外袋体の外表面に、子宮頸部に適合可能な窪み部が形成されるように構成することで、膣内部支持具を膣内に挿入する際に、窪み部で、下垂している子宮頸部を押し込みながら、膣内部支持具全体を膣内に挿入することができる。例えば、図１２に示すように、第１バルーン８０の袋部８３を、第２バルーン８０’及び第３バルーン８０’’の袋部８３’，８３’’で部分的に取り囲むことによって窪み部Ｕを形成することができる。 Further, the vaginal internal support device includes two or more balloons, and by inflating both of the two or more balloons, a hollow portion that can fit the cervix is formed on the outer surface of the outer bag body. With this configuration, when inserting the intravaginal support device into the vagina, the entire vagina internal support device can be inserted into the vagina while pushing the cervix hanging down at the depression. For example, as shown in FIG. 12, the bag portion 83 of the first balloon 80 is partially surrounded by the bag portions 83 ′ and 83 ″ of the second balloon 80 ′ and the third balloon 80 ″, thereby forming the depression U. Can be formed.
　また、図１３（ａ）に示すように、袋部の一部の領域を高弾性コンプライアンスの材料で形成することによって袋部の外表面に凸部Ｐを形成したり、図１３（ｂ）に示すように、袋部の外表面に突起体Ｑを配置したりすることで、これら凸部Ｐや突起体Ｑのいずれかを、前掲図６（ａ）及び（ｂ）に示した恥骨組織Ｃに外袋体及び膣前壁を介して係止させたり、膣壁内の凹部に外袋体を介して適合させたりして、膣内部支持具を膣内に確実に保持することができる。 Further, as shown in FIG. 13A, a convex portion P is formed on the outer surface of the bag portion by forming a partial region of the bag portion with a material having high elastic compliance. As shown, the protrusion Q is arranged on the outer surface of the bag portion, so that either the protrusion P or the protrusion Q is connected to the pubic tissue C shown in FIGS. 6 (a) and 6 (b). The inner vaginal support can be securely held in the vagina by engaging the outer bag body with the outer bag body and the front wall of the vagina or by fitting the recess in the vagina wall with the outer bag body.
　また、膣内部支持具が２つ以上のバルーンを備え、２つ以上のバルーンのうち少なくとも１つは、バルーンの袋部が、他の少なくとも１つのバルーンの袋部より細長い形状を有するようにしてもよい。図１４（ａ）の例では、蔓巻状の袋部９０を有するバルーンと、細長形状の袋部９１を有する２つのバルーンとを設け、並列配置した２つの細長形状の袋部９１の周囲に、蔓巻状の袋部９０を巻き付けた構成としている。このような構成とすることで、膣内部支持具の表面に複数の凸形状部を形成することができ、これら複数の凸形状部のいずれかを、前掲図６に示した恥骨組織Ｃに膣前壁を介して係止させたり、膣壁内の凹部に適合させたりして、膣内部支持具を膣内に確実に保持することができる。 Further, the intravaginal support device includes two or more balloons, and at least one of the two or more balloons has a balloon bag portion having an elongated shape than the other at least one balloon bag portion. Also good. In the example of FIG. 14 (a), a balloon having a bellows-like bag portion 90 and two balloons having an elongated bag portion 91 are provided, and around two elongated bag portions 91 arranged in parallel. In addition, it is configured such that a vine-shaped bag portion 90 is wound. With such a configuration, a plurality of convex portions can be formed on the surface of the vagina internal support, and any one of the plurality of convex portions is applied to the pubic tissue C shown in FIG. The internal support for the vagina can be securely held in the vagina by being locked through the front wall or adapted to the recess in the vagina wall.
　また、図１４（ｂ）の例では、細長い袋部９２を折畳んで外袋体内に収納した構成にすることで、膨張時に外袋体を膣前後方向（図中の矢印方向）に膨張し易くし、その結果、外袋体を、前掲図６に示した恥骨組織Ｃに膣前壁を介して係止させ易くしている。 In the example of FIG. 14 (b), the elongate bag portion 92 is folded and stored in the outer bag body, so that the outer bag body expands in the vaginal front-rear direction (arrow direction in the figure) when inflated. As a result, the outer bag body is easily locked to the pubic tissue C shown in FIG. 6 through the anterior vagina wall.
　また、図１５（ａ）に示すように、リング状の袋部９３を有する２つのバルーンと、細長形状の袋部９４を有するバルーンとを設け、縦列配置した２つのリング状の袋部９３の貫通孔を、細長形状の袋部９４で貫通させた構成としてもよい。また、図１５（ｂ）に示すように、膣内部支持具が２つ以上のバルーンを備え、２つ以上のバルーンは、互いに、例えばエラストマーやプラスチックなどバルーンよりも弾性コンプライアンスが低い材料からなる保持部材Ｒによって接合された構成とすることもできる。このような構成とすることで、膣内部支持具全体が変形しにくくなるため、膣内部支持具を膣内に挿入し易くすることができる。また、体動に伴う膣内部の変形に対し、膣内部支持具を脱離し難くすることもできる。 15A, two balloons having a ring-shaped bag portion 93 and balloons having an elongated bag portion 94 are provided, and two ring-shaped bag portions 93 arranged in tandem are arranged. It is good also as a structure which penetrated the through-hole with the elongate bag part 94. FIG. Further, as shown in FIG. 15B, the intravaginal support device includes two or more balloons, and the two or more balloons are each made of a material having a lower elastic compliance than that of the balloon, such as an elastomer or plastic. It can also be set as the structure joined by the member R. FIG. By setting it as such a structure, since the whole vagina internal support tool becomes difficult to deform | transform, it can make it easy to insert a vagina internal support tool in a vagina. In addition, it is possible to make it difficult for the internal support of the vagina to be detached from deformation inside the vagina accompanying body movement.
　また、図１６に示すように、膣内部支持具の膣後壁側の外表面に、膣内部支持具を膣内から取り除く際に患者が指を引っ掛けるための凹み部Ｗを設けることもできる。さらに、図１７に示すように、膣内部支持具の外表面に、膣奥側から膣入口側に向かって延びる溝部Ｔを設け、当該溝部Ｔを通じて膣分泌物を排出可能に構成することもできる。なお、溝部Ｔに代えて、膣内部支持具を貫通する貫通孔を設けてもよい。 Also, as shown in FIG. 16, a recess W for a patient to hook a finger when removing the vagina inner support from the vagina can be provided on the outer surface of the vagina inner wall on the vagina rear wall side. Furthermore, as shown in FIG. 17, a groove T extending from the back of the vagina toward the vagina inlet side may be provided on the outer surface of the vagina internal support, and the vaginal secretion can be discharged through the groove T. . Instead of the groove T, a through hole that penetrates the vagina internal support may be provided.
　上述したところは、本発明の一実施形態を示したにすぎず、特許請求の範囲において、種々の変更を加えることができる。例えば、外袋体は、バルーンの口部、開閉部及び袋部全体を収納するものとして説明したが、必ずしもそのような構成に限られず、外袋体は、バルーンの袋部を収納していればよい。また、膣内部支持具が備えるバルーンの数は、２つとしたり、４つ以上とすることもできる。 The above description shows only one embodiment of the present invention, and various modifications can be made within the scope of the claims. For example, the outer bag body has been described as accommodating the mouth portion, the opening / closing portion, and the entire bag portion of the balloon. However, the outer bag body is not necessarily limited to such a configuration, and the outer bag body may accommodate the balloon bag portion. That's fine. Further, the number of balloons provided in the vaginal internal support may be two, or four or more.
　１，１’　膣内部支持具
　２　流体注入デバイス
　２０　バルーン
　２１　口部
　２１ａ　テーパ面
　２２　開閉部
　２２ａ　貫通孔
　２２ｂ　逆止弁
　２３　袋部
　３０　外袋体
　４０　リング体（押圧部）
　５０　注入部
　５１，５１’，５１’’　注入口
　５２　チューブ
　５３　外チューブ
　６０，６０’，６０’’　調整操作部
　６１　内筒
　６１ａ　目盛
　６２　内押子
　６２ａ　内ガスケット
　６２ｂ　内押子ロッド
　６２ｃ　内押子フランジ
　６３，６３’，６３’’　摘み
　７０　注入操作部
　７１　外筒
　７１ａ　スリット
　７１ｂ　開放端部
　７２　外押子
　７２ａ　外ガスケット
　７２ｂ　外押子ロッド
　７２ｃ　外押子フランジ
　７３　キャップ
　８０　第１バルーン
　８０’　第２バルーン
　８０’’　第３バルーン
　８２，８２’，８２’’　開閉部
　８３，８３’，８３’’　袋部
　９０　蔓巻状の袋部
　９１　細長形状の袋部
　９２　細長い袋部
　９３　リング状の袋部
　９４　細長形状の袋部
　Ｓ　空間
　Ｃ　恥骨組織
　Ｎ　子宮頸部
　Ｏ　軸線
　Ｕ　窪み部
　Ｐ　凸部
　Ｑ　突起体
　Ｒ　保持部材
　Ｗ　凹み部
　Ｔ　溝部 1, 1 'Vaginal internal support 2 Fluid injection device 20 Balloon 21 Mouth 21a Tapered surface 22 Opening / closing part 22a Through hole 22b Check valve 23 Bag part 30 Outer bag body 40 Ring body (pressing part)
50 Injecting portion 51, 51 ', 51''Inlet 52 Tube 53 Outer tube 60, 60', 60 '' Adjusting operation portion 61 Inner cylinder 61a Scale 62 Inner pusher 62a Inner gasket 62b Inner pusher rod 62c Inner pusher Flange 63, 63 ′, 63 ″ knob 70 injection operation portion 71 outer cylinder 71a slit 71b open end 72 outer pusher 72a outer gasket 72b outer pusher rod 72c outer pusher flange 73 cap 80 first balloon 80 ′ second Balloon 80 ″ Third balloon 82, 82 ′, 82 ″ Open / close portion 83, 83 ′, 83 ″ Bag portion 90 Vine-shaped bag portion 91 Elongate bag portion 92 Elongate bag portion 93 Ring-shaped bag portion 94 Elongated bag part S Space C Pubic tissue N Uterine cervix O Axis line U Depression part P Convex part Q Protrusion R Holding member W Concavity part T Groove part

Claims (8)

  1. 　骨盤臓器脱の治療に用いられる、膣内に挿入された状態で膨張収縮可能な膣内部支持具において、
    　流体を通過させる開放状態と流体の通過を遮断する遮断状態との間で切り換え動作可能な開閉部と、該開閉部を介した流体の流入によって膨張可能であると共に、前記開閉部を介した流体の流出によって収縮可能である袋部と、を有するバルーンと、
    　前記バルーンの袋部を収納し、該袋部の膨張収縮に伴って膨張収縮可能な外袋体と
    を備えることを特徴とする膣内部支持具。     In the vaginal internal support device that can be expanded and contracted while inserted into the vagina, used for treatment of pelvic organ prolapse,
    An opening / closing part that can be switched between an open state that allows fluid to pass through and a blocking state that blocks passage of fluid, and is expandable by the inflow of fluid through the opening / closing part, and the fluid via the opening / closing part A balloon having a bag portion that is shrinkable by the outflow of
    A vaginal internal support device comprising: an outer bag body that houses the bag portion of the balloon and that can expand and contract as the bag portion expands and contracts.
  2. 　前記バルーンを２つ以上備え、
    　前記外袋体は、前記２つ以上のバルーンの袋部をいずれも収納し、該袋部の膨張収縮に伴って膨張収縮可能である、請求項１に記載の膣内部支持具。     Comprising two or more balloons,
    The vaginal internal support device according to claim 1, wherein the outer bag body stores both of the bag portions of the two or more balloons, and can expand and contract as the bag portions expand and contract.
  3. 　前記２つ以上のバルーンのうち少なくとも１つは、該バルーンの袋部の膨張によって、他のバルーンの袋部を膣前壁に向かって押圧する、請求項２に記載の膣内部支持具。 The intravaginal support device according to claim 2, wherein at least one of the two or more balloons presses the bag portion of the other balloon toward the vaginal front wall by the expansion of the bag portion of the balloon.
  4. 　前記２つ以上のバルーンは、互いに異なる弾性コンプライアンスを有する、請求項２又は３に記載の膣内部支持具。 The vaginal internal support device according to claim 2 or 3, wherein the two or more balloons have different elastic compliances.
  5. 　前記２つ以上のバルーンをいずれも膨張させることによって、外袋体の外表面に、子宮頸部に適合可能な窪み部が形成される、請求項２～４のいずれか一項に記載の膣内部支持具。 The vagina according to any one of claims 2 to 4, wherein a hollow portion adapted to the cervix is formed on the outer surface of the outer bag body by inflating the two or more balloons. Internal support.
  6. 　前記１つ以上のバルーンの前記開閉部をいずれも取り囲むリング状の押圧部をさらに備え、
    　各開閉部は、各袋部への流体の流入を許容するが、各袋部からの流体の流出は遮断する逆止弁をそれぞれ有し、
    　前記逆止弁はいずれも、前記リング状の押圧部を所定の周方向位置で内側に圧迫することによって、各袋部からの流体の流出を許容する、請求項１～５のいずれか一項に記載の膣内部支持具。     A ring-shaped pressing portion that surrounds both the opening and closing portions of the one or more balloons;
    Each open / close section allows a flow of fluid into each bag, but has a check valve that blocks outflow of fluid from each bag,
    6. The check valve according to claim 1, wherein the check valve allows the fluid to flow out from each bag portion by pressing the ring-shaped pressing portion inward at a predetermined circumferential position. The vaginal internal support.
  7. 　請求項１～６のいずれか一項に記載の膣内部支持具を膨張させるための流体注入デバイスであって、
    　前記膣内部支持具に接続し、前記開閉部に連通する注入口を有する注入部と、
    　前記注入部の注入口に送る流体の量を調整可能な調整操作部と、
    　前記調整操作部によって調整された量の流体を、前記注入部の注入口に圧送させる注入操作部と
    を備えることを特徴とする流体注入デバイス。     A fluid injection device for inflating a vaginal internal support device according to any one of the preceding claims,
    An injection part connected to the vaginal internal support and having an injection port communicating with the opening and closing part;
    An adjustment operation unit capable of adjusting the amount of fluid sent to the injection port of the injection unit;
    A fluid injection device comprising: an injection operation unit that pumps an amount of fluid adjusted by the adjustment operation unit to an injection port of the injection unit.
  8. 　前記注入部は、２つ以上の前記バルーンを備える前記膣内部支持具に接続し、前記２つ以上のバルーンの各開閉部にそれぞれ連通する２つ以上の注入口を有し、
    　前記調整操作部は、前記注入部の各注入口に送る流体の量をそれぞれ調整可能であり、
    　前記注入操作部は、前記調整操作部によって調整された量の流体をそれぞれ、前記注入部の各注入口に圧送させる、請求項７に記載の流体注入デバイス。     The injection part is connected to the vaginal internal support device including two or more balloons, and has two or more injection ports respectively communicating with the opening / closing parts of the two or more balloons,
    The adjustment operation unit can adjust the amount of fluid sent to each injection port of the injection unit,
    The fluid injection device according to claim 7, wherein the injection operation unit causes the amount of fluid adjusted by the adjustment operation unit to be pumped to each injection port of the injection unit.
PCT/JP2013/002378 2013-04-05 2013-04-05 Intravaginal support tool and fluid injection device WO2014162363A1 (en)

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Cited By (2)

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Publication number Priority date Publication date Assignee Title
CN108135732A (en) * 2015-08-20 2018-06-08 沃特金斯-康迪产品股份有限公司 Flexible conical intravaginal support device
EP3906900A1 (en) 2020-05-06 2021-11-10 Stichting Radboud universitair medisch centrum Vaginal device for prolapse treatment

Citations (2)

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US4669478A (en) * 1985-03-21 1987-06-02 Robertson Jack R Device for diagnosing and relieving female incontinence
JP2009513215A (en) * 2005-10-25 2009-04-02 エシコン・インコーポレイテッド Adjustable vaginal splint for pelvic floor support

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4669478A (en) * 1985-03-21 1987-06-02 Robertson Jack R Device for diagnosing and relieving female incontinence
JP2009513215A (en) * 2005-10-25 2009-04-02 エシコン・インコーポレイテッド Adjustable vaginal splint for pelvic floor support

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108135732A (en) * 2015-08-20 2018-06-08 沃特金斯-康迪产品股份有限公司 Flexible conical intravaginal support device
CN108135732B (en) * 2015-08-20 2020-08-14 沃特金斯-康迪产品股份有限公司 Flexible conical vaginal support device
EP3906900A1 (en) 2020-05-06 2021-11-10 Stichting Radboud universitair medisch centrum Vaginal device for prolapse treatment
WO2021224332A1 (en) 2020-05-06 2021-11-11 Stichting Radboud Universitair Medisch Centrum Vaginal device for prolapse treatment

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