Uterine hemostatic set

Abstract

To provide an instrument set for uterine hemostasis suppressing coming-off of a tube from a vaginal opening and being comfortable to wear on a mother's body.SOLUTION: An instrument set for uterine hemostasis includes: a balloon 2 to be inserted into the uterus of a mother body; a tube 3 to which the balloon 2 is fixed on the tip side, and including a drainage passage 32a for draining blood in the uterus to the outside and a fluid passage 32b for injecting fluid into the balloon 2, formed therein, to be inserted into the vagina; a stopper attached to a proximal side of the tube 3, the member including a drainage through-hole formed therein for communicating with the drainage passage 32a to drain the blood in the uterus to the outside and regulating coming-off of the tube 3 from the vaginal opening, the stopper including a holding part exposed from the vaginal opening, being held by a vulva area of the vaginal opening; and a shorts-type supporter being worn on the mother's body to come into contact with the holding part of the stopper and suppressing coming-off of the balloon 2 from the uterus and coming-off of the tube 3 from the vaginal opening.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates to a uterine hemostatic set device. [Background technology]

[0002] In recent years, a fixing support device for a uterine hemostatic balloon unit that suppresses bleeding in the uterus and stops the bleeding has been proposed (see, for example, Patent Document 1).

[0003] The uterine hemostatic balloon unit described in Patent Document 1 includes a flexible tube and a balloon attached to the tip of the tube. The fixing support for the uterine hemostatic balloon unit includes a tube stopper that supports the tube and a fixing member that fixes the tube stopper to the mother's body. The tube stopper has a clamping portion that clamps the tube, and the fixing member is composed of an abdominal belt that is attached to the mother's abdomen and a band that connects the tube stopper to the abdominal belt. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] International Publication No. 2020 / 208993 Summary of the Invention [Problem to be solved by the invention]

[0005] In conventional uterine hemostatic balloon units, the tube stopper is designed to clamp any position on the tube, so the length of the tube inserted into the vagina from the vaginal opening to the balloon (inside the uterus) can be adjusted to an appropriate length to suit the mother. In addition, the fixing support device connects the tube stopper to the abdominal belt with a band, which is expected to have the effect of preventing the uterine hemostatic balloon unit from slipping out of the uterus.

[0006] However, as uterine contractions progress after delivery and the gap with the balloon becomes smaller, the force pushing the balloon out of the uterus becomes stronger, and even though it is connected to the abdominal belt with a band, the force in the direction of removal is strong, and there is a concern that the uterine hemostatic balloon unit may slip out of place with the band.In addition, the mother may feel uncomfortable due to discharged fluids such as blood leaking along the outer surface of the tube, and the base end of the tube of the uterine hemostatic balloon unit protrudes outside the body, restricting body movement, so the maternal fixation support device is not very comfortable to wear.

[0007] An object of the present invention is to provide a set device for uterine hemostasis that prevents a tube from coming out of the vaginal opening and that is comfortable to wear for the mother. [Means for solving the problem]

[0008] In order to solve the above problem, we provide a set device for uterine hemostasis, which includes: a balloon to be inserted into the uterus of a mother; a tube to which the balloon is fixed at the tip end, which is inserted into the vagina and has a first passage for draining blood from the uterus to the outside and a second passage for injecting fluid into the balloon; a restricting member attached to the base end of the tube, which is connected to the first passage and has a third passage for draining blood from the uterus to the outside, and which is a member to restrict the tube from slipping out of the vaginal opening, the exposed part of which is held by the surrounding tissue of the vaginal opening; and a shorts-type slipping-out prevention member that comes into contact with the exposed part of the restricting member when attached to the mother, and prevents the balloon from slipping out of the uterus and the tube from slipping out of the vaginal opening. [Effects of the Invention]

[0009] According to the present invention, it is possible to provide a set device for uterine hemostasis that prevents a tube from coming out of the vaginal opening and that is comfortable to wear for the mother. [Brief explanation of the drawings]

[0010] [Figure 1]FIG. 1 is an external view showing an example of a balloon unit constituting a set instrument for uterine hemostasis according to an embodiment of the present invention. [Figure 2] Figure 2(a) is a cross-sectional view showing an example of the internal structure of a balloon unit, Figure 2(b) is a cross-sectional view of a key part showing an example of the internal structure of a connecting tube shown in Figure 2(a), and Figure 2(c) is a cross-sectional view taken along line AA shown in Figure 2(b). [Figure 3] FIG. 3 is a perspective view of the stopper. [Figure 4] FIG. 4(a) is a vertical cross-sectional view of the stopper, and FIG. 4(b) is a view showing an example of the rear end surface of the holding portion. [Figure 5] FIG. 5 is a development view showing an example of a shorts-type supporter. [Figure 6] FIG. 6 is a front view showing an example of a state in which the supporter is attached to the mother's body. [Figure 7] FIG. 7 is a side view schematically showing an example of a state in which the balloon unit is attached to the mother body. DETAILED DESCRIPTION OF THE INVENTION

[0011] Hereinafter, embodiments of the present invention will be described with reference to the drawings. In the drawings, components having substantially the same functions are designated by the same reference numerals, and redundant description thereof will be omitted.

[0012] <Overall composition> 1 is an external view showing an example of a balloon unit constituting a set device for uterine hemostasis according to an embodiment of the present invention. This set device for uterine hemostasis comprises a balloon unit 1 that inserts a balloon 2 into the uterus to stop bleeding within the uterus, and a shorts-type supporter 10 that prevents the balloon 2 from slipping out of the uterus when worn on the mother's body. The shorts-type supporter 10 is an example of a shorts-type slip-out prevention member.

[0013] The balloon unit 1 includes an inflatable and deflateable balloon 2 inserted into the uterus; a flexible tube 3 inserted into the vagina, with the balloon 2 at its distal end, a drainage route for draining bleeding from the uterus, and a fluid route to the balloon 2; a connector 4 connected to an injection device that injects fluid into the balloon 2 via the fluid route; and a stopper 5, which communicates with the drainage route of the tube 3 to drain blood from the uterus and prevent the tube 3 from slipping out of the vaginal opening, and whose retaining portion 53 (see FIGS. 3 and 4 ) exposed from the vaginal opening is retained in the vulva of the vaginal opening. The supporter 10 is attached to the mother's body so as to cover the retaining portion 53 of the stopper 5, thereby preventing the tube 3 from slipping out of the vaginal opening. Here, the stopper 5 is an example of a restricting member. The retaining portion 53 is an example of an exposed portion exposed from the vaginal opening. The vulva is an example of tissue surrounding the vaginal opening.

[0014] (Balloon configuration) The balloon 2 is formed from an elastic, flexible material such as silicone resin so that it can deflate when fluid is removed and expand when fluid is injected. The balloon 2 is shown in an expanded state in Fig. 1, and in Fig. 2(a), which will be described later, it is shown in a contracted state. The balloon 2 is inserted into the uterus in a deflated state, and when inflated, it compresses the inside of the uterus (the bleeding area) to stop the bleeding.

[0015] 2(a) and 2(b), the distal end 2a is joined to the distal tip 31, and the proximal end 2b is joined to the distal end of the inner-layer tube shaft 33A by adhesive bonding, welding, etc. The balloon 2 may be formed by blow molding or the like from a material with little elasticity, such as a film material such as polyurethane or polyvinyl chloride.

[0016] <Tube configuration> Fig. 2(a) is a cross-sectional view showing an example of the internal structure of the balloon unit 1, Fig. 2(b) is a cross-sectional view of a main part showing an example of the internal structure of the connection tube shown in Fig. 2(a), and Fig. 2(c) is a cross-sectional view taken along line AA shown in Fig. 2(b). As shown in Fig. 2(a), the tube 3 includes a distal tip 31, a connection tube 32 connected to the distal tip 31, and a tube shaft 33 connected to the connection tube 32.

[0017] (Tip configuration) The distal tip 31 is provided so as to be exposed approximately 20 to 30 mm distal to the balloon 2 of the tube 3. The distal tip 31 has an opening 31a that communicates with a drainage passage 32a of the connecting tube 32 to discharge drainage fluids such as blood from within the uterus, and has multiple drainage holes 31b on its side. The outer peripheral surface of the distal tip 31 is connected to the distal end 2a of the balloon 2, and the inner peripheral surface is connected to the connecting tube 32. The distal tip 31 is formed from a material such as silicone, fluororesin, or polyurethane.

[0018] (Connection tube configuration) The connecting tube 32 connects the distal tip 31 and the inner-layer tube shaft 33A. The outer peripheral surface of the connecting tube 32 forms the inner wall surface of the balloon 2, separating the balloon 2 from the drainage passage 32a and providing part of the fluid route to the balloon 2.

[0019] Specifically, the connection tube 32 has a circular cross section and is provided with multiple lumens, including a lumen for a drainage passage 32a for draining blood from within the uterus to the outside and a lumen for a fluid passage 32b that serves as a fluid route to the balloon 2. The fluid passage 32b that serves as the fluid route to the balloon 2 is connected to multiple side holes 32d that lead to the interior of the balloon 2. The opening on the distal end side of the fluid passage 32b is closed by a stopper 32c joined by bonding, welding, or the like, and the opening on the proximal end side is connected to a connection tip 41 of a fluid route tube 42 by bonding, welding, or the like. The stopper 32c and the connection tip 41 are formed from a material such as silicone, fluororesin, or polyurethane.

[0020] (Tube shaft configuration) The tube shaft 33 is thicker on the side closer to the balloon 2 and thinner on the proximal end side. That is, the thicker portion of the tube shaft 33 has a two-layer structure made up of the inner-layer tube shaft 33A and the outer-layer tube shaft 33B, while the thinner portion has a single-layer structure made up of only the outer-layer tube shaft 33B. The inner-layer tube shaft 33A and the outer-layer tube shaft 33B are formed by extrusion molding or the like from an elastic material such as silicone, fluororesin, or polyurethane to provide flexibility. The inner-layer tube shaft 33A and the outer-layer tube shaft 33B may also be formed integrally.

[0021] A drainage passage is connected to the tube shaft 33 from its tip connected to the balloon 2 to its rear end. That is, the hollow of the inner-layer tube shaft 33A and the hollow of the outer-layer tube shaft 33B of the tube shaft 33 serve as drainage passages 33a and 33b, respectively, which communicate with the drainage passage 32a of the connecting tube 32.

[0022] The side closest to the balloon 2, which is inserted into the vagina, has a two-layer structure consisting of the inner-layer tube shaft 33A and the outer-layer tube shaft 33B, which prevents the tube shaft 33 from collapsing and provides a thick-walled section with sufficient strength for easy insertion. On the other hand, the base end farther from the balloon 2 has a thin-walled section consisting only of the outer-layer tube shaft 33B. This thin-walled section becomes flexible and can serve as a length-adjustment section 33c that can be easily cut at any position to adjust the length of the tube shaft 33 when connecting it to the stopper 5 (described later). In this case, the outer-layer tube shaft 33B may be thinner than the inner-layer tube shaft 33A. Furthermore, by providing both a thick-walled section and a thin-walled section in the tube shaft 33, the strength of the inserted portion of the vagina can be maintained, while the thin-walled section serving as the length-adjustment section 33c can be easily cut at any position according to the length of the mother's vagina. The length of the tube shaft 33 may also be adjusted according to the location of the bleeding site. This allows the balloon 2 to be fixed to the bleeding site.

[0023] (Connector configuration) The connector 4 includes a connection tip 41, a fluid route tube 42, and a tapered valve connector 43. The fluid route tube 42 is inserted midway through the lumen of the tube 3. That is, the fluid route tube 42, which serves as a route for injecting and discharging fluid into and from the balloon 2, has its tip connected to the lumen on the fluid route side of the connection tube 32 via the connection tip 41 and extends to the base end, protruding from midway through the drainage passage 33a of the tube shaft 33. The base end of the extended fluid route tube 42 is provided with a luer taper for connecting to a syringe or the like for injecting and discharging fluid, and a tapered valve connector 43 equipped with a valve for controlling the flow of fluid from the balloon 2.

[0024] An injection device that injects a fluid into the balloon 2 via the fluid route tube 42 is connected to the tapered valve connector 43. With this configuration, the fluid is injected from the injection device into the balloon 2 via the tapered valve connector 43, the fluid route tube 42, the connection tip 41, the fluid passage 32b, and the side hole 32d.

[0025] (Stopper configuration) Fig. 3 is a perspective view of the stopper 5, Fig. 4(a) is a longitudinal cross-sectional view of the stopper 5, and Fig. 4(b) is a diagram showing an example of the rear end surface of the holding portion. Note that Fig. 4(b) shows by a dashed line the state in which the base end side of the tube shaft 33 is attached to the stopper 5.

[0026] The stopper 5 has a through hole 54 for detachably attaching the base of the tube 3, and holds the tube 3 at the vaginal opening. The stopper 5 has a tubular portion 51 to which the tube shaft 33 is attached and which is inserted into the vagina, a holding portion 53 which is held at the vulva, and a tapered portion 52 which transitions gently between the tubular portion 51 and the holding portion 53.

[0027] The holding portion 53 is formed with a drainage hole 54a communicating with the drainage passage 32a of the connecting tube 32 and the drainage passages 33a, 33b of the tube shaft 33 to drain intrauterine blood to the outside, and a leakage hole 55 for draining fluid leaking along the outer peripheral surface 5a of the tube shaft 33 and the stopper 5 to the outside. The holding portion 53 has a substantially elliptical rear end surface 53a and a heart-shaped configuration with a recess 53b and a pair of protrusions 53c, 53c at the apex of at least one side (the abdominal side) of the major axis. The rear end surface 53a of the holding portion 53 is the contact surface with the supporter 10 and is formed as a flat surface. The holding portion 53, including its side surfaces, is formed in a shape without corners (e.g., an elliptical, oblong, heart-shaped, etc.), and the surface opposite the rear end surface 53a is the contact surface with the vulva. For this reason, it is preferable that the edges of the holding portion 53 be formed as curved surfaces. Furthermore, it is preferable that the rear end surface 53a has a sufficient area to come into contact with the supporter 10 so that the holding portion 53 can be securely held at the vulva.

[0028] The rear end surface 53a of the retaining portion 53 has, for example, a heart shape. If the abdominal side of the rear end surface 53a were simply the apex of an ellipse, the apex would contact the abdomen and dig in, causing discomfort to the mother. However, the heart shape allows the shape to conform to the surrounding tissue, allowing the stopper 5 to be worn without a poor fit. In other words, when the tubular portion 51 of the stopper 5 is inserted into the vagina and the retaining portion 53 is held at the vulva, the tapered portion 52 may come into contact with the mother's body. A retaining portion 53 formed into a flat shape without corners or a roughly elliptical shape such as a heart shape (a simple ellipse would cause pain at the contact point) can reduce discomfort to the mother. Furthermore, because the rear end surface 53a of the retaining portion 53 is flat and the peripheral surface is curved, it fits well into the supporter 10, ensuring a more secure hold.

[0029] Furthermore, the rear end surface 53a of the holding part 53 is provided with a drainage hole 54a that communicates with the tube shaft 33, as well as a leakage hole 55 at an eccentric position on the major axis of the approximately elliptical shape. This allows the drainage liquid that leaks from the tube shaft 33 along the outer surface 5a of the stopper 5 to be discharged into the supporter 10 without accumulating on the contact surface with the vulva, reducing discomfort caused by drainage or leakage liquid accumulating in the vulva or rear end surface 53a.

[0030] (Supporter Composition) Figure 5 is a development view showing an example of a shorts-type supporter 10. Supporter 10 is designed to cover the buttocks and lower abdomen and is wrapped around the waist to hold it in place, forming a shorts shape when worn and fixing stopper 5 to the vulva. Supporter 10 has a back 11 (rear body), a crotch 12 (crotch cloth), a front 13 (front body), and a horizontally long waist belt 14 attached to back 11 for wrapping around the waist, and has an overall T-shaped development.

[0031] The waist belt 14 is placed around the waist and secured at the front by hook-and-loop fasteners 15a and 15b, while the back 11, crotch 12, and front 13 wrap from the buttocks to the lower abdomen and are secured to the waist belt 14 by hook-and-loop fasteners 15c and 15d, and the garment is worn on the mother's body. The crotch 12 is the part that comes into contact with the rear end surface 53a of the stopper 5, so it preferably has an area that completely covers the rear end surface 53a of the stopper 5. By completely covering the entire rear end surface 53a of the stopper 5 with the supporter 10 in this way, the tube shaft 33 can be reliably secured with minimal misalignment. Completely covering the stopper 5 with the supporter 10 prevents the balloon 2 from slipping out of the uterus. Furthermore, because the balloon unit 1 fits within the supporter 10, with the exception of the connector 4 that ensures a fluid route to the balloon 2, there are fewer restrictions on the mother's movements, improving the wearing comfort.

[0032] At least the portion of the supporter 10 including the crotch 12 (the portion that presses the stopper 5) is made of a highly water-absorbent polymeric absorbent material (for example, an absorbent high molecular weight polymer). This allows drainage such as blood discharged from the drainage holes 54a, leaking down the tube shaft 33, and leaking from the liquid leakage holes 55 to be absorbed by the absorbent material, thereby preventing the mother from getting wet with drainage or leaking liquid and reducing discomfort when wearing the supporter. Therefore, there is no need to provide an outlet hole in the supporter 10 for leading the tube shaft 33 to the outside for drainage. Furthermore, because the supporter 10 has an unfolded shape, it can be worn without significant movement of the mother, and the size can be adjusted to suit the mother.

[0033] <How to use> Next, an example of how to use the set device for uterine hemostasis will be described with reference to Figures 6 and 7. Figure 6 is a front view showing an example of how the supporter 10 is attached to the mother's body. Figure 7 is a side view schematically showing an example of how the balloon unit 1 is attached to the mother's body.

[0034] (1) Adjusting the length of the tube shaft The length of the tube shaft 33 is adjusted by cutting the length adjustment portion 33c on the base end side of the outer layer tube shaft 33B at any position of the length adjustment portion 33c according to the length of the vagina 101 of the mother 100.

[0035] (2) Insert the tube shaft into the stopper The base end of the tube shaft 33, which has been cut to an appropriate length, is inserted into the through-hole 54 of the stopper 5. That is, as shown in FIG. 4(a), the base end of the tube shaft 33 is inserted into the through-hole 54 of the stopper 5 until the cut surface 33d of the tube shaft 33 abuts against the flange portion that forms the drainage through-hole 54a of the stopper 5.

[0036] (3) Insertion into the mother's body 7, the tube 3 and the cylindrical portion 51 of the stopper 5 are inserted through the vagina 101, and the balloon 2 is positioned inside the uterus 103. At this time, the balloon 2 is in a deflated state because no fluid has been injected into it yet.

[0037] (4) Inflation of balloon 2 Fluid is injected from the injection device into the balloon 2 via the connector 4 to inflate the balloon 2, compressing the inside of the uterus 103, including the cervix 102. This stops bleeding at the anticipated bleeding site 102a. At this time, if necessary, fine-tune the axial position of the tube shaft 33 to confirm that the stopper 5 is securely held in the vulva 104.

[0038] (5) Wearing a supporter As shown in FIGS. 6 and 7, the supporter 10 is fitted to the mother's body and fixed at an appropriate position with hook-and-loop fasteners 15a to 15d so as to completely cover the entire stopper 5.

[0039] (6) Hemostasis by leaving the device in place for a certain period of time The balloon is left in place for about 12 hours (maximum 24 hours) to stop bleeding. At this time, the amount of fluid in the balloon 2 is adjusted as necessary.

[0040] (Effects of this embodiment) According to this embodiment, the following effects are achieved. (a) By wearing the shorts-type supporter 10 on the mother 100, the supporter 10 comes into contact with the rear end surface 53a of the stopper 5, preventing the balloon 2 from slipping out of the uterus 103 and the tube 3 from slipping out of the vaginal opening. (b) The rotation direction of the stopper 5 relative to the tube 3 can be adjusted, and the rear end surface 53a of the holding portion 53 exposed from the vaginal opening has a roughly elliptical shape whose major axis is the longitudinal direction of the mother body 100 and is eccentric with respect to the central axis of the tube 3, thereby reducing the discomfort felt by the mother body 100 when wearing it. (c) The stopper 5 can discharge the leaked liquid that leaks along the outer surface of the tube 3 and the stopper 5 to the outside through the leaked liquid through hole 55 formed at an eccentric position on the long axis of the rear end face 53a. (d) The absorbent material of the supporter 10 can absorb the drainage liquid discharged from the drainage hole 54a of the stopper 5 and the leaking liquid discharged from the leaking hole 55, so that the mother body 100 can be prevented from getting wet with the drainage liquid or the leaking liquid, and the discomfort of wearing the supporter can be reduced. (e) As described above, the set device for uterine hemostasis according to this embodiment can prevent the balloon 2 placed in the uterus from coming out and stop bleeding, and can also reduce discomfort felt by the mother when wearing the device.

[0041] Although the embodiments of the present invention have been described above, the embodiments of the present invention are not limited to the above-described embodiments, and various modifications and implementations are possible.

[0042] Furthermore, some of the components of the above-described embodiments may be omitted or modified, and in the methods of using the above-described embodiments, steps may be added, deleted, modified, or replaced. [Explanation of symbols]

[0043] 1...balloon unit, 2...balloon, 2a, 2b...ends of balloon, 3...tube, 4...connector, 5...stopper, 5a...outer surface, 10...Supporter, 11...Back, 12...Crotch, 13...Front, 14...waist belt, 15a to 15d...hook and loop fastener, 31...tip, 31a...opening, 31b...discharge hole, 32...connection tube, 32a...discharge passage, 32b...fluid passage, 32c...plug, 32d...side hole, 33...tube shaft, 33A...inner layer tube shaft, 33B...outer layer tube shaft, 33a, 33b... drainage passage, 33c... length adjustment portion, 33d... cutting surface, 41...connection tip, 42...fluid route tube, 43...taper valve connector, 51... cylindrical portion, 52... tapered portion, 53... holding portion, 53a... rear end surface, 53b... recess, 53c... convex portion, 54... through hole, 54a... drainage through hole, 55... leakage through hole, 100... parent body, 101…Vagina, 102…Uterine cervix, 102a…Bleeding area, 103…Uterus, 104…Vulva

Claims

1. a balloon inserted into the mother's uterus; a tube to which the balloon is fixed at the distal end, the tube having a drainage passage for draining blood from the uterus to the outside, and a fluid passage for injecting fluid into the balloon, the tube being inserted into the vaginal opening; a restricting member attached to the base end side of the tube, having a drainage hole communicating with the drainage passage for discharging blood from the uterus to the outside, and restricting the tube from coming out of the vaginal opening, the exposed portion of which is held by the tissue surrounding the vaginal opening; a shorts-type slip-out prevention member that is attached to the mother's body and comes into contact with the exposed portion of the restricting member to prevent the balloon from slipping out of the uterus and the tube from slipping out of the vaginal opening; A set of instruments for uterine hemostasis.

2. a rotational direction of the restricting member relative to the tube is adjustable, and a surface of the base end side of the exposed portion has a substantially elliptical shape with a major axis extending in the longitudinal direction of the base body; The uterine hemostatic set instrument according to claim 1.

3. The restricting member has a liquid leakage hole formed at an eccentric position on the longitudinal axis, through which the discharged liquid leaking along the outer circumferential surface of the tube and the restricting member is discharged to the outside. The uterine hemostatic set instrument according to claim 2.

4. The exposed portion has a recess formed at a top on the long axis on the side where the liquid leakage through hole is formed. The uterine hemostatic set instrument according to claim 3.

5. The tube has a thick-walled portion on the side closer to the balloon and a thin-walled portion on the base end side farther from the balloon, and the thin-walled portion has a length adjustment portion that can be cut according to the length of the vagina. A set instrument for uterine hemostasis according to any one of claims 1 to 4.

Images