Uterine hemostasis set instrument

Abstract

To provide a uterine hemostasis set instrument reliably preventing a balloon from slipping out of a uterus by achieving adjusting of the position of the balloon inserted into the uterus appropriately to a mother body.SOLUTION: A uterine hemostasis set instrument comprises: a balloon unit 1 consisting of a balloon 2 to be inserted into a uterus, a drainage passage 3 having the balloon 2 at the tip thereof and communicating a flow path from the inside of the uterus to outside the body, a fluid passage 4 for injecting / discharging fluid with respect to the balloon 2, and a connector 5 provided at the end of the fluid passage 4; a stopper 10 for inserting the drainage passage 3, provided on the proximal side of the balloon 2 and holding the balloon 2 in the uterus; and a shorts-type supporter 100 to be worn on the mother's body and preventing the stopper 10 from coming off from the vagina. The stopper 10 is so formed as to be able to change the length thereof in the axial direction of the drainage passage 3. The length-variable stopper 10 is formed of an inner cylinder 11 and an outer cylinder 12 that are screwed together, or a plurality of fixed segments 21 that is connected together.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to a uterine hemostatic set device for stopping bleeding in the uterus. [Background technology]

[0002] Conventionally, the BT method (Ballon tampоnade method) is known for controlling bleeding in the uterus after childbirth by inflating a hemostatic balloon inserted into the uterus. The uterine hemostatic balloon used in the BT method is composed of a hemostatic balloon that compresses the bleeding area to stop the bleeding, a tube equipped with the balloon at the tip, a drainage passage for draining blood and the like from the uterus to the outside of the body, and a fluid passage for injecting and discharging fluid into and from the balloon. The balloon is inserted into the uterus vaginally in the case of natural childbirth, or through an abdominal incision in the case of Caesarean section, and the balloon is inflated by injecting fluid to compress the bleeding area to stop the bleeding.

[0003] Many of the failures in hemostatic treatment using the BT method are attributed to the balloon slipping out of the cervical opening, and failure of hemostatic treatment can lead to serious situations in which hysterectomy or other procedures may be considered. In order to prevent the balloon from slipping out of the uterus, a set device for uterine hemostasis has been proposed that includes a cylindrical stopper that is inserted into the vagina in a manner that inserts the base end of the tube to restrict the balloon from slipping out, and a shorts-type supporter that is attached to the mother's body and comes into contact with the base end of the stopper, preventing the stopper from slipping out of the vagina. (Patent Document 1) [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Patent Application No. 2022-082804 Summary of the Invention [Problem to be solved by the invention]

[0005] According to the configuration of Patent Document 1, the balloon is held down by a stopper, and the stopper is held down by a shorts-type supporter, thereby preventing the balloon from slipping out of the uterus.

[0006] However, the stopper in Patent Document 1 is formed integrally with the tubular part inserted into the vagina and the holding part held by the tissue around the vaginal opening, and the size cannot be adjusted to fit the mother's body. Therefore, there is a concern that it may cause discomfort when worn, and that the length from the vaginal opening to the hemostatic balloon may cause misalignment between the hemostatic balloon and the bleeding site, or that it may not be possible to sufficiently control the falling off of the hemostatic balloon.

[0007] Therefore, the objective of the present invention is to provide a set device for uterine hemostasis that allows the position of a balloon inserted into the uterus to be appropriately adjusted to match the mother's body and reliably prevents the balloon from slipping out of the uterus. [Means for solving the problem]

[0008] In order to solve the above problems, the set device for uterine hemostasis of the present invention is composed of a balloon unit consisting of a balloon to be inserted into the uterus, a drainage passage having the balloon at its tip and connecting a flow path from inside the uterus to outside the body, a fluid passage for injecting and discharging fluid into the balloon, and a connector at the end of the fluid passage, a stopper that is placed in the vagina in a manner that inserts the drainage passage proximal to the balloon and holds the balloon within the uterus, and a shorts-type supporter that is attached to the mother's body to prevent the stopper from slipping out of the vagina, and the stopper is formed so that its length can be changed in the axial direction of the drainage passage.

[0009] The stopper is formed so that an outer cylinder arranged on the balloon side and an inner cylinder arranged on the body surface side are screwed together.

[0010] The outer cylinder and the inner cylinder are preferably formed as follows. The proximal end of the inner cylinder is provided with a flange. The outer cylinder is made of an elastic material. The distal side of the outer tube is provided with a concave contact surface that conforms to the shape of the balloon.

[0011] In another embodiment, the stopper is composed of a plurality of donut-shaped fixing segments, the number and / or size of which may be selectively combined and axially connected to the drainage passage.

[0012] The fixed segment is preferably constructed or formed as follows. The fixing segments each have a convex portion on the proximal side and a concave portion on the distal side, and the convex portion and the concave portion of each of the fixing segments fit together to connect the fixing segments. The fixation segment includes a notch that guides the drainage passage into the lumen. The distal side of the fixing segment is provided with a concave contact surface that conforms to the shape of the balloon and contacts the balloon. Effect of the Invention

[0013] According to the present invention, it is possible to provide a set device for uterine hemostasis that can reliably prevent the balloon from slipping out of the uterus by making it possible to appropriately adjust the position of the balloon inserted into the uterus to suit the mother and maintaining it in that appropriate position. [Brief description of the drawings]

[0014] [Figure 1] FIG. 1 is an overall configuration diagram of a uterine hemostatic set instrument according to a first embodiment of the present invention. [Diagram 2] FIG. 3 is a cross-sectional view of the balloon unit according to the embodiment. [Diagram 3] FIG. 4 is a half-sectional view of the stopper according to the embodiment. [Figure 4] FIG. 4 is a side view showing a schematic view of the uterine hemostasis set instrument according to the embodiment attached to a mother's body. [Diagram 5] FIG. 11 is an external view of a balloon unit equipped with a stopper in a second embodiment of the present invention. [Figure 6] FIG. 4 is a diagram showing a fixed segment according to the embodiment. [Figure 7] FIG. 4 is a half-sectional view of the stopper according to the embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] Hereinafter, a first embodiment of the present invention will be described with reference to the drawings. Fig. 1A is an external view of a balloon unit and a stopper installed in the balloon unit constituting a set device for uterine hemostasis according to the first embodiment of the present invention, and Fig. 1B is an external view of a shorts-type supporter according to this embodiment. Fig. 2A is a cross-sectional view showing the internal structure of the balloon unit according to this embodiment, Fig. 2B is a cross-sectional view of a main part showing an example of the internal structure of the connection tube shown in Fig. 2A, and Fig. 2C is a cross-sectional view taken along line A-A shown in Fig. 2B.

[0016] This form of uterine hemostasis set device is composed of a balloon unit 1 that inserts a balloon 2 into the uterus to stop bleeding within the uterus, a stopper 10 that is placed inside the vagina at the base end of the balloon unit 1 to hold the balloon 2 within the uterus, and a shorts-type supporter 100 that is attached to the mother's body to hold down the stopper 10 and inhibit the stopper 10 from slipping out of the vagina, thereby preventing the balloon 2 from slipping out of the uterus.

[0017] The balloon unit 1 consists of an inflatable and deflated balloon 2 to be inserted into the uterus, a drainage passage 3 located at the tip end of the balloon 2 for draining bleeding within the uterus to the outside of the body, a fluid passage 4 for injecting fluid into the balloon 2 and discharging fluid from the balloon 2, and a connector 5 serving as a fluid injection / discharge port located at the base end of the fluid passage 4.

[0018] The balloon 2 is formed in a cylindrical shape in a deflated state, and when used, it is inflated inside the uterus to compress the bleeding area inside the uterus to stop bleeding. As shown in Figures 2A and 2B, the distal end 2a of the balloon 2 is joined to the distal tip 31, and the proximal end 2b is joined to the distal end of the tube shaft 33 by adhesion, welding, etc., and a connection tube 32 connected between the distal tip 31 and the tube shaft 33 is housed.

[0019] The balloon 2 is formed from an elastic and flexible material such as silicone resin so that it can be in a deflated state when fluid is removed and in an inflated state when fluid is injected. Fig. 1 shows the inflated state, and Fig. 2A shows the deflated state. The balloon 2 may be formed by blow molding or the like from a material that has almost no elasticity, such as a film material such as polyurethane or polyvinyl chloride.

[0020] The length of the balloon 2 before inflation is about 75 mm, and the maximum outer diameter when inflated is about 70 mm, taking into consideration the size of the lower uterine segment. The size of the balloon 2 when inflated can be adjusted by the amount of fluid injected depending on the situation, and in this example, the amount injected is set to about 500 ml.

[0021] 2A, the drainage passage 3 is composed of a distal tip 31, a connection tube 32 connected to the base end side of the distal tip 31, and a tube shaft 33 connected to the connection tube 32. The drainage passage 3 is formed by extrusion molding or the like from an elastic material such as silicone, fluororesin, or polyurethane so as to have flexibility.

[0022] The distal tip 31 is provided so as to be exposed about 20 to 30 mm toward the distal end side from the balloon 2, and is provided with at least one of an opening 31a at the distal end communicating with a drainage route 32a of the connecting tube 32 and a plurality of drainage holes 31b at the side in order to discharge drainage fluid such as blood in the uterus. The distal tip 31 has an outer peripheral surface connected to the end 2a on the distal side of the balloon 2, and an inner peripheral surface connected to the connecting tube 32.

[0023] The connection tube 32 connects the distal tip 31 and the tube shaft 33, and its outer surface forms the inner wall surface inside the balloon 2, separating the balloon 2 from the drainage route 32a and forming part of the fluid route to the balloon 2.

[0024] Specifically, the connection tube 32 has a circular cross section as shown in Fig. 2c, and includes a plurality of lumens, including a lumen of a drainage route 32a for discharging blood in the uterus to the outside, and a lumen of a fluid route 32b communicating with a fluid passage 4 to the balloon 2 described below. The fluid route 32b communicates with a plurality of side holes 32d leading to the inside of the balloon 2. The tip opening of the fluid route 32b is closed by a plug 32c joined by adhesion, welding, or the like, and the base end opening is connected to a connection tip 41 of the fluid passage 4 by adhesion, welding, or the like. The plug 32c and the connection tip 41 are formed of a material such as silicone, fluororesin, polyurethane, or the like.

[0025] The outer peripheral surface of the tip side of the tube shaft 33 is connected to the end 2b on the base end side of the balloon 2, and the inner peripheral surface is connected to the outer peripheral surface on the base end side of the connection tube 32. In addition, a drainage route is connected from the tip connected to the balloon 2 to the rear end. In other words, the hollow of the tube shaft 33 serves as a drainage route that is connected to the drainage route 32a of the connection tube 32.

[0026] During use, the base end of the tube shaft 33 is passed through a slit 102a of the shorts-type supporter 100 described below, and a drainage bag or the like (not shown) is connected to drain blood and other fluids from within the uterus. Therefore, the length of the tube shaft 33 is preferably about 200 mm, which is long enough to pass from the balloon base end through the slit 102a of the shorts-type supporter 100 and connect to a drainage bag.

[0027] The fluid passage 4 includes a connection tip 41 and a fluid tube 42. The fluid tube 42 is inserted into the middle of the lumen of the tube shaft 33. That is, the fluid tube 42, which is a route for injecting and discharging fluid into the balloon 2, has a tip connected to the lumen on the fluid route 32b side of the connection tube 32 via the connection tip 41, and extends to the base end side by protruding from an arbitrary position in the middle of the tube shaft 33. The base end of the extended fluid tube 42 has a connector 5 for injecting and discharging fluid. Although the fluid passage 4 in this embodiment protrudes from the middle of the tube shaft 33, it may be inserted into the tube shaft 33.

[0028] The connector 5 is connected to an injection device (such as a syringe) that injects fluid into the balloon 2 via the fluid tube 42, and is equipped with a check valve that controls the flow of fluid from the balloon 2. When the syringe is connected to the connector 5, the check valve opens the flow path to allow injection and discharge of fluid, and when the syringe is removed, the valve closes to block the flow path. With this configuration, fluid is injected from the injection device into the balloon 2 via the connector 5, the fluid tube 42, the connection tip 41, the fluid route 32b, and the side hole 32d.

[0029] Fig. 3A is an outer tube constituting the stopper, Fig. 3B is a half-side cross-sectional view of the inner tube constituting the stopper, and Fig. 3C is a half-side cross-sectional view of the stopper combining the outer tube and the inner tube. The stopper 10 is composed of a cylindrical outer tube 11 and an inner tube 12, and is detachably attached by inserting a tube shaft 33 therein. The tip side of the outer tube 11 abuts against the balloon 2, thereby holding the position of the balloon 2 in the uterus.

[0030] The outer cylinder 11 is formed in a cylindrical shape with a female thread 11a on its inner circumferential surface, and a concave surface 11b is formed on the tip side so as to abut against the base end side of the inflated balloon 2. Although the outer cylinder 11 of the stopper 10 may be formed from a hard resin, it is preferable to form it from an elastic material in consideration of the wearing comfort of the mother.

[0031] The inner cylinder 12 is formed in a cylindrical shape with a male thread 12a on the outer circumferential surface, and the inner cavity serves as an insertion hole 12c for inserting the tube shaft 33. In addition, a flange 12b may be provided on the base end side of the inner cylinder.

[0032] The outer tube 11 and the inner tube 12 are screwed together by a female thread 11a and a male thread 12a, respectively. An operator can adjust the length of the stopper 10 by turning the inner tube 12 relative to the outer tube 11. In this embodiment, turning the inner tube 12 clockwise shortens the stopper 10, and turning the inner tube 12 counterclockwise lengthens the stopper 10.

[0033] The outer tube 11 and the inner tube 12 are each formed to a length of about 90 mm so as to reproduce the length from the vaginal opening to the balloon, taking into consideration the length of the mother's vagina. The outer diameter of the inner tube 12 is set to match the inner diameter (described later) of the outer tube 11, and the inner diameter is appropriately set (about 18 mm in this embodiment) depending on the thickness of the tube shaft 33. The flange 12b provided at the proximal end of the inner tube 12 is set to a size that does not get in the way when the stopper 10 is placed and does not impair operability (outer diameter 50 mm, thickness 5 mm in this embodiment). The diameter of the outer tube 11 is set to an outer diameter that allows for easy insertion into the vagina and a thickness that provides a contact surface for fixing the balloon 2 (outer diameter 35 mm, inner diameter 22 mm in this embodiment).

[0034] According to the stopper 10 of this embodiment, the outer tube 11 and the inner tube 12 are screwed together, so that the length of the stopper 10 can be changed in the axial direction, and the length of the stopper 10 can be adjusted to suit the mother's body. Also, the outer tube 11 is made of an elastic material, so it is gentle to the mother's body. Furthermore, the flange 12b is provided on the base end side of the inner tube 12, so that the operability when adjusting the length of the stopper 10 is improved, and the contact area with the shorts-type supporter 100 is also increased, so that the fixation is reliable.

[0035] 1B is a development view showing an example of a shorts-type supporter 100. The shorts-type supporter 100 covers the buttocks and lower abdomen and is wrapped around the waist to hold it in place, forming a shorts shape when worn and fixing the stopper 10 inside the vagina. The shorts-type supporter 100 has a back 101 (rear body), a crotch 102 (crotch cloth), a front 103 (front body), and a horizontally long waist belt 104 that is attached to the back 101 and is worn around the waist, and has an overall T-shaped development.

[0036] The waist belt 104 is wrapped around the waist and secured at the front by hook-and-loop fasteners 105a and 105b, and the back 101, crotch 102 and front 103 wrap from the buttocks to the lower abdomen and are secured to the waist belt 104 by hook-and-loop fasteners 105c and 105d, and are worn on the mother's body.

[0037] Since the crotch 102 is the portion that comes into contact with the flange 12b of the stopper 10, it is preferable that the crotch 102 has an area that completely covers the flange 12b of the stopper 10. By completely covering the entire flange 12b of the stopper 10 with the shorts-type supporter 100 in this manner, the stopper 10 can be securely fixed. By securely fixing the stopper 10, it is possible to prevent the balloon 2 from slipping.

[0038] Furthermore, a slit 102a is provided in at least a portion of the shorts-type supporter 100 including the crotch 102 (the portion that holds down the stopper 10) through which the tube shaft 33 and connector 5 of the drainage passage 3 are inserted. It is preferable to provide a plurality of slits 102a (for example, in this embodiment, five slits in a vertical row when viewed from the front in a developed view), and the size of the slits 102a is appropriately set to match the diameter of the tube shaft 33 so that the tube shaft 33 can pass through and be appropriately fixed. The tube shaft 33 that has passed through the slit 102a is connected to a drainage bag.

[0039] According to the above-mentioned configuration, the shorts-type supporter 100 has an unfolded shape, so that it can be worn without significant movement of the mother, and the size can be adjusted according to the mother's body. Furthermore, by providing a slit 102a in the crotch 102, the tube shaft 33 is exposed to the outside of the shorts-type supporter 100 through the slit 102a. Therefore, the base end side of the tube shaft 33 can be connected to a drainage bag, and drainage from the uterus is contained in the drainage bag, preventing the mother's body from being soiled with drainage such as blood from the uterus. Furthermore, since multiple slits 102a are provided, the slit 102a most suitable for the mother's body can be selected, preventing excessive bending of the tube shaft 33 and reducing discomfort to the mother.

[0040] Next, an example of a method of using the present invention will be described with reference to Fig. 4. Fig. 4 is a side view showing a schematic example of a state in which the set device for uterine hemostasis of the present invention is attached to a mother's body.

[0041] (1) Attaching the stopper 10 to the balloon unit 1 The length of the stopper 10 is roughly adjusted, and the tube shaft 33 is inserted into the stopper 10 . (2) Insertion into the mother’s body 4, the balloon unit 1 is inserted from the vagina 1001, and the balloon 2 is positioned inside the uterus 1003. At this time, the balloon 2 is in a deflated state since no fluid has been injected into it yet. (3) Inflation of balloon 3 A fluid (sterile purified water) is injected from an injection device through a connector 5 into the balloon 2 to expand the balloon 2 and apply pressure to the inside of the uterus 1003 including the cervical canal 1002. This stops the bleeding at the anticipated bleeding site 1002a. (4) Adjustment of stopper 10 The axial length of the drainage passage 3 of the stopper 10 is adjusted by screwing in accordance with the length of the mother's vagina. The above steps (1) to (4) may be appropriately interchanged depending on the situation. In this embodiment, only the drainage passage 3 is inserted into the stopper 10, but the fluid passage 4 may also be inserted therein. (5) Wearing a shorts-type supporter The shorts-type supporter 100 is fitted to the mother's body and secured in an appropriate position with hook-and-loop fasteners 105a to 105d so as to completely cover the entire stopper 10. (6) Hemostasis by placing the device 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.

[0042] 5 is an external view of a balloon unit and a stopper installed in the balloon unit that constitute a set device for uterine hemostasis in the second embodiment of the present invention. The structure of the balloon unit 1 and the shorts-type supporter 100 in this embodiment is basically the same as that in the first embodiment, so a description of the similar parts will be omitted and only the stopper, which is the different part, will be described.

[0043] The stopper 20 in this embodiment is composed of a plurality of donut-shaped fixing segments 21, and the length is adjusted by changing the number and / or size of the plurality of fixing segments 21. 6 shows a perspective view (A), a plan view (B), a bottom view (C), and a front view (D) of the fixed segment in this embodiment. Fixed segment 21 is preferably configured to include segment body 22 formed in a doughnut shape with a cutout portion 221 in the circumferential direction, convex portion 23 provided on the proximal side of segment body 22, and concave portion 24 provided on the distal side, and is integrally molded from an elastic member.

[0044] The segment body 22 is formed in a doughnut shape with a cutout portion 221 in the circumferential direction, and the inside forms an insertion hole 25 into which the tube shaft 33 is inserted. The insertion hole 25 and the cutout portion 221 communicate with each other, and the tube shaft 33 is guided into the insertion hole 25 through the cutout portion 221.

[0045] The protrusion 23 is provided on the proximal side of the segment main body 22, and a constricted portion 23a is provided between the protrusion 23 and the segment main body 22. The recess 24 is formed on the distal side of the segment main body 22 in a manner following the shape of the protrusion 23 so as to fit with the protrusion 23.

[0046] The fixing segments 21 are connected by engaging the convex portion 23 with the concave portion 24. The distal side of the segment body 22 is concave, forming an abutment surface 26 with the base end side of the inflated balloon 2 and the proximal side of the connected segment body 22.

[0047] According to the stopper 20 having the above configuration, the fixing segments 21 can be connected by the interlocking convex portions 23 and concave portions 24, so that the length of the stopper 20 can be adjusted by combining the number and / or size of the fixing segments 21. Therefore, the length of the stopper 20 can be set to suit the mother's body, and the balloon unit 1 can be securely fixed. Furthermore, by providing a constricted portion 23a on the segment body 22 side of the convex portions 23, the distal side of the concave portions 24 is caught by the constricted portion 23a, ensuring a secure fit. Furthermore, each fixing segment 21 is made of an elastic material, so it is gentle to the mother's body.

[0048] In this example, all the segment bodies 22 have the same shape, but a plurality of shapes of different sizes may be used. Also, the convex portion 23 is formed with a constricted portion 23a so that the cross-sectional shape is uniformly semi-cylindrical along the circumferential direction, but the present invention is not limited to this as long as the convex portion 23 and the concave portion 24 can be engaged with each other to connect the segment bodies 22.

[0049] Although the embodiment of the present invention has been described above, the embodiment of the present invention is not limited to the above embodiment, and various modifications and implementations are possible. In addition, some of the components of the embodiment of the present invention may be removed or changed. In addition, in the above-mentioned method of use, steps may be added, deleted, changed, replaced, etc. [Explanation of symbols]

[0050] 1 Balloon unit 2. Balloon 2a End of balloon 2b End of balloon 3 Drainage passage 31 Tip 31a aperture 31b Discharge hole 32 Connecting tube 32a Drainage route 32b Fluid Route 32c Stopper 32d side hole 33 Tube shaft 4 Fluid passage 41 Connection Chip 42 Fluid Tube 5 Connectors 10 Stopper 11 Outer cylinder 11a Female thread 11b concave surface 12 Inner cylinder 12a Male thread 12b flange 12c Insertion hole 20 Stopper 21 Fixed Segments 22 Segment body 221 Notch 23 Convex 23a Neck 24 Recess 25 Insertion hole 26 Contact surface 100 Shorts-type supporter 101 Back 102 Crotch 102a Slit 103 Front 104 Waist belt 105 Hook and Loop Fastener

Claims

1. A balloon unit including a balloon to be inserted into the uterus, a drainage passage having the balloon at its tip and communicating a flow path from the uterus to the outside of the body, a fluid passage for injecting and discharging fluid into the balloon, and a connector provided at the end of the fluid passage; a stopper that is provided in the vagina in a manner that inserts the drainage passage proximal to the balloon and holds the balloon in the uterus; A shorts-type supporter that is attached to the mother's body to prevent the stopper from slipping out of the vagina. A set device for uterine hemostasis, characterized in that the length of the stopper is variable in the axial direction of the drainage passage.

2. 2. The uterine hemostatic set device according to claim 1, wherein the stopper is composed of an outer tube arranged on the balloon side and an inner tube arranged on the body surface side, and the outer tube and the inner tube are formed to be slidable.

3. The set instrument for uterine hemostasis according to claim 2 , wherein a screw mechanism is formed on the inner peripheral surface of said outer cylinder and the outer peripheral surface of said inner cylinder.

4. The uterine hemostatic set device of claim 2 , wherein the proximal end of the inner barrel comprises a flange.

5. 3. The uterine hemostatic set instrument of claim 2, wherein said outer sleeve is molded from an elastic material.

6. The uterine hemostatic set device according to claim 1, wherein the stopper is composed of a plurality of donut-shaped fixing segments, and the number and / or size of the fixing segments are selectively combined and connected in the axial direction of the drainage passage.

7. The uterine hemostasis set instrument according to claim 6, wherein the fixing segments each have a convex portion on a proximal side and a concave portion on a distal side, and the fixing segments are connected together by fitting together the convex portion and the concave portion of each of the fixing segments.

8. 7. The uterine hemostatic set device of claim 6, wherein said fixation segment includes a notch for guiding said drainage passageway into an internal cavity.

9. 9. A set instrument for uterine hemostasis according to claim 1, wherein the distal side of the stopper is provided with a concave contact surface that conforms to the shape of the balloon and contacts the balloon.

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