Uterine packing hemostatic balloon and use method thereof

Abstract

The invention belongs to the technical field of interventional medical devices, and in particular relates to a uterine tamponade hemostatic balloon and a method for using the same; the uterine tamponade hemostatic balloon comprises a balloon and a catheter group, the balloon comprises a body cavity balloon and two uterine horn balloons, the uterine horn balloons are attached and fixed to the outer surface of the balloon, and the uterine horn balloons and the body cavity balloons are not connected inside; a method for using the uterine tamponade hemostatic balloon is characterized by comprising the following steps: step A, after vaginal delivery of the placenta, checking the bleeding situation and determining the site of uterine bleeding; step B, delivering the uterine tamponade hemostatic balloon into the uterine cavity through the cervical os; step C, connecting a drainage bag to the lower end of the drainage tube and regularly recording the amount of uterine cavity bleeding; step D, injecting physiological saline into different balloon bodies according to the site of uterine bleeding; step E, taking out the balloon after the bleeding stops; the invention can solve the problem that there is currently no effective hemostatic measure for placental adhesion and uterine contraction weakness caused by placenta attachment to the uterine horn in clinical practice.

Description

Technical Field

[0001] The invention belongs to the technical field of interventional medical devices, and in particular relates to a uterine packing hemostatic balloon and a use method thereof. Background Art

[0002] In the clinic, parturients with placenta attached to the uterine horns are often encountered. Due to poor postpartum uterine contraction, especially poor contraction of the uterine horns, a large amount of bleeding occurs, which leads to laparotomy to suture the uterus or even hysterectomy. At present, there is no effective hemostatic measure for placental adhesion and uterine contraction weakness caused by placenta attachment to the uterine horns. Although there is also a method of using a balloon (Bayri balloon) to compress the uterus to stop bleeding in the prior art, it is mainly designed for lower uterine bleeding, and there is no effective treatment and hemostatic measure for uterine horn bleeding. When the placenta is attached to the uterine horns, placental adhesion or placental retention is prone to occur. After manual placental peeling or curettage, the amount of bleeding on the placental attachment surface is large. Because this part is angled with the uterine body cavity, the existing balloon cannot effectively compress the uterine horn part, the hemostatic effect is poor, and the amount of postpartum bleeding is large, and laparotomy to ligate the uterus or perform hysterectomy is often required. Summary of the invention

[0003] In view of this, the present invention aims to provide a uterine tamponade hemostatic balloon and a method of using the same, so as to solve the current clinical problem of lack of effective hemostatic measures for placental adhesion and uterine atony caused by placenta attachment to the uterine horn.

[0004] To achieve the above object, the technical solution of the present invention is achieved as follows:

[0005] A uterine tamponade hemostatic balloon comprises a balloon and a catheter assembly, wherein the balloon comprises a body cavity balloon and two uterine horn balloons, wherein the uterine horn balloons are attached and fixed to the outer surface of the balloon and the uterine horn balloons and the body cavity balloons are not connected to each other, and the two uterine horn balloons are respectively located at the upper left corner and the upper right corner of the body cavity balloon;

[0006] The catheter group includes a main balloon catheter, a side balloon catheter and a drainage tube. The main balloon catheter connects the body cavity balloon with the injection port of an external syringe. The side balloon catheter connects the two uterine horn balloons with the injection ports of an external syringe respectively. The drainage tube passes through the body cavity balloon, and the upper end of the drainage tube extends out of the body cavity balloon. The lower end of the drainage tube is connected to a drainage bag.

[0007] Furthermore, the included angle between the central axes of the two uterine cornu sacs 12 at the intersection is α, and the range of angle α is 90° to 120°.

[0008] Furthermore, the length of the upper end of the drainage tube extending out of the body cavity bag is 8-10 mm.

[0009] Furthermore, the catheter group also includes an outer sleeve, through which the main balloon catheter, the side balloon catheter and the drainage tube are tightly wrapped to form an integral tube bundle structure, and at the position where the catheter group penetrates into the body cavity balloon, the outer wall of the outer sleeve is sealed and fixedly connected to the body cavity balloon;

[0010] The upper end of the main balloon catheter is located in the body cavity bag, the lower end of the main balloon catheter passes through the outer sleeve to pass through the body cavity bag and a control valve is installed near the outlet, the upper end of the side balloon catheter is bifurcated to form branch tube 1 and branch tube 2, the upper ends of branch tube 1 and branch tube 2 pass through the cavity wall of the body cavity bag and extend into the uterine cornu sac to communicate with the uterine cornu sac, the lower end of the side balloon catheter passes through the outer sleeve to pass through the body cavity bag and a control valve is installed near the outlet; the drainage tube is installed with a control valve near the interface between it and the drainage bag.

[0011] Furthermore, a recessed portion is provided at the lower portion of the body cavity bag, and an anti-slip protrusion is provided on the surface of the recessed portion.

[0012] Furthermore, a protrusion is arranged on the top of the uterine cornu sac.

[0013] Furthermore, it also includes multiple pressure sensors, which are attached and installed at different positions on the surface of the balloon; wherein, a No. 1 pressure point is respectively arranged on both sides of the raised part of the uterine cornu sac, and a pressure sensor is installed at each No. 1 pressure point; two No. 2 pressure points are symmetrically arranged at the lower part of the body cavity sac, and a pressure sensor is installed at each No. 2 pressure point; the pressure sensor is connected to a controller through a communication signal, and the controller is electrically connected to an external display.

[0014] Furthermore, the perpendicular lines of the tangents of the two No. 1 compression points 41 at the uterine cornu sac 12 have an angle β at the intersection, and the range of the β angle is 70° to 100°; the perpendicular lines of the tangents of the two No. 2 compression points 42 at the body cavity sac 11 have an angle γ at the intersection, and the range of the γ angle is 90° to 150°.

[0015] Furthermore, the pressure sensor adopts a flexible film pressure sensor.

[0016] A method for using a uterine tamponade hemostatic balloon comprises the following steps:

[0017] Step A: After vaginal delivery of the placenta, press the uterine fundus to understand the height of the uterine fundus and the contraction of the uterus, check and repair the soft birth canal, check the bleeding, and determine the site of uterine bleeding;

[0018] Step B, inserting the uterine tamponade hemostatic balloon into the uterine cavity through the cervical os;

[0019] Step C, connecting the drainage bag to the lower end of the drainage tube, and regularly recording the amount of uterine bleeding;

[0020] Step D, injecting normal saline into different cysts according to the site of uterine bleeding;

[0021] Step E: After the balloon is placed, monitor uterine bleeding at any time. When the bleeding stops, remove the balloon.

[0022] Furthermore, in step B, when the uterine tampon hemostatic balloon is sent into the uterine cavity through the cervical os, it is necessary to ensure that the balloon is accurately placed. The specific method is: slowly send the balloon from the cervical os into the uterine cavity, and when you feel push resistance, that is, the end of the drainage tube just touches the top of the uterus, stop pushing inward; at the same time, cooperate with B-ultrasound monitoring to check whether the balloon position is accurate, and adjust the balloon position appropriately according to the results of B-ultrasound monitoring.

[0023] Further, in step D, the method of injecting physiological saline into different capsules is:

[0024] Method 1: When the bleeding site is located in the lower uterine segment, inject normal saline into the body cavity bag through the main bag catheter with a syringe. The maximum injection volume is 800 ml. First, inject 350-400 ml and monitor the value of the pressure sensor at the second pressure point, that is, the uterine contraction force. When the uterine contraction force reaches or approaches 150 mmHg, stop injecting water and close the control valve.

[0025] Method 2: When the bleeding site is located at the uterine cornu, first inject normal saline into the body cavity sac according to the method described in method 1, and then inject normal saline into the uterine cornu sac through the side sac catheter by syringe. The maximum injection volume is 200 ml. First inject 50-100 ml, and monitor the pressure sensor values ​​at the four No. 1 pressure points, that is, the uterine cornu contraction force. When the uterine contraction force reaches or approaches 150 mmHg, inject another 10-20 ml as appropriate, stop water injection, and close the control valve;

[0026] Method 3: When postpartum bleeding prevention is needed, use the operation described in method 2 as a preventive measure for postpartum hemorrhage.

[0027] Furthermore, in step E, the value fed back by the pressure sensor installed on the surface of the balloon is used to monitor the uterine bleeding in real time. The data is analyzed according to the value of the pressure at each point recorded in the display, that is, the uterine contraction force and the contraction force of the uterine horns on both sides, and the contraction force of the uterine horns on both sides is compared. The uterine contraction is analyzed through data monitoring, and the oxytocin drip rate and dosage are adjusted in time to wait for the body to exert its own coagulation function to form a thrombus, and guide the next step of diagnosis and treatment; if the postpartum uterine contraction force value is close to or reaches 350mmHg, if there is not much vaginal bleeding at this time, indicating that the uterine contraction force is good, the oxytocin drip rate can be adjusted to the regular dose; if the postpartum uterine contraction force value is much less than 350mmHg, it is necessary to observe the amount of vaginal bleeding while increasing the oxytocin drip rate or dosage.

[0028] According to the values ​​of the uterine pressure at each point recorded on the display, when the postpartum uterine contraction force reaches 350-400mmHg, it indicates that the uterine contraction force is good. The balloon can be withdrawn based on the actual amount of postpartum bleeding.

[0029] Compared with the prior art, the present invention has the following advantages:

[0030] The balloon compresses the inner wall of the uterus, especially the lower uterine segment and the uterine cornu, by providing a body cavity capsule and a uterine cornu capsule, so that the uterine spiral artery is compressed. When the pressure in the uterine cavity is greater than the uterine spiral artery pressure, arterial bleeding is reduced until it stops. Similarly, the uterine venous plexus is compressed to reduce bleeding. After the main balloon of the balloon is injected with normal saline, it expands and compresses the uterine cavity, reflexively causing uterine contraction and blood vessel closure to reduce bleeding. This solves the problem that when the placenta attaches to the uterine cornu and causes massive bleeding in the uterine cornu, the existing balloon (Bayri balloon) cannot effectively compress the uterine cornu and effectively stop bleeding, thereby avoiding excessive postpartum bleeding and avoiding laparotomy, ligation of the uterus or hysterectomy.

[0031] Moreover, the compression mode can be flexibly selected according to the actual bleeding location. When the placenta is attached in the normal position and postpartum bleeding occurs, the body cavity sac can be activated to stop bleeding. If the placenta is attached to the uterine cornu or near the uterine cornu, the body cavity sac and the uterine cornu sac can be activated at the same time to perform compression to stop bleeding. This method can also be used for preventive use of postpartum hemorrhage. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The accompanying drawings constituting a part of the present invention are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. In the accompanying drawings:

[0033] Figure 1 It is a schematic diagram of the external structure of the present invention;

[0034] Figure 2 This is a schematic diagram of the distribution of the catheter group inside the balloon;

[0035] Figure 3 is a schematic diagram of the structure of the catheter group;

[0036] Figure 4 It is a schematic diagram of the structure of the side balloon catheter;

[0037] Figure 5 This is a schematic diagram of the placement of the balloon in the uterus;

[0038] Figure 6 Schematic diagram of the placement of the cornual sac at the cornu uterus.

[0039] Description of reference numerals:

[0040] 11-body cavity sac; 111-depression; 112-anti-slip protrusion; 12-uterine horn sac; 121-protrusion; 2-catheter set; 21-main sac catheter; 22-side sac catheter; 221-branch tube 1; 222-branch tube 2; 23-drainage tube; 231-drainage bag; 24-outer cannula; 25-control valve; 3-uterus; 31-uterine horn; 32-uterine os; 41-pressure point No. 1; 42-pressure point No. 2. DETAILED DESCRIPTION

[0041] It should be noted that, in the absence of conflict, the embodiments of the present invention and the features in the embodiments may be combined with each other.

[0042] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and the like are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, features defined as "first", "second", and the like may explicitly or implicitly include one or more of the features. In the description of the present invention, unless otherwise specified, "multiple" means two or more.

[0043] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood by specific circumstances.

[0044] The present invention will be described in detail below with reference to the accompanying drawings and in conjunction with embodiments.

[0045] like Figure 1-6 As shown, a uterine tamponade hemostatic balloon includes a balloon and a catheter set 2, the balloon includes a body cavity balloon 11 and two uterine horn balloons 12, the uterine horn balloons 12 are attached and fixed to the outer surface of the balloon, and the uterine horn balloons 12 and the body cavity balloon 11 are not connected, and the two uterine horn balloons 12 are respectively located at the upper left corner and the upper right corner of the body cavity balloon 11;

[0046] The catheter group 2 includes a main balloon catheter 21, a side balloon catheter 22 and a drainage tube 23. The main balloon catheter 21 connects the body cavity balloon 11 with the injection port of an external syringe, and the side balloon catheter 22 connects the two uterine horn balloons 12 with the injection ports of an external syringe respectively. The drainage tube 23 passes through the body cavity balloon 11, and the upper end of the drainage tube 23 extends out of the body cavity balloon 11, and the lower end of the drainage tube 23 is connected to a drainage bag 231.

[0047] When using the hemostatic balloon, physiological saline can be injected / extracted into the body cavity balloon 11 and the two uterine horn balloons 12 through the main balloon catheter 21 or the side balloon catheter 22 respectively. The upper end of the drainage tube 23 is located in the uterine cavity, and its function is to guide and drain the blood in the uterus 3 in time.

[0048] Preferably, the angle between the central axes of the two uterine angle capsules 12 at the intersection is α, and the range of α is 90° to 120°. Theoretically, the postpartum uterine angle is 90°, and α is also 90°. Considering the actual situation, such as poor postpartum uterine contraction or poor contraction due to placental attachment, the uterine angle may increase, and the α angle will also increase accordingly, so the α angle range is set to 90° to 120°.

[0049] Preferably, the length of the upper end of the drainage tube 23 extending outside the body cavity bag 11 is 8-10 mm, and there is an opening at the end for draining blood. The length of the exposed section is selected in combination with the structure of the uterus 3. In order to ensure that the balloon is accurately placed in the uterus 3, when the balloon is placed in the uterus 3, when the end of the drainage tube 23 abuts against the top of the uterus 3, the body cavity bag 11 just presses on the lower segment of the uterus 3 (the bleeding site). At the same time, the two uterine cornu sacs 12 are just located at the uterine cornu 31. Because the placement of the balloon mainly relies on the doctor's touch operation, when it is felt that the end of the drainage tube 23 just abuts against the top of the uterus 3, it can be used as a signal that the balloon is accurately placed, providing a reference for the doctor's operation.

[0050] Preferably, if Figure 3 As shown, the catheter group 2 also includes an outer sleeve 24, through which the main balloon catheter 21, the side balloon catheter 22 and the drainage tube 23 are tightly wrapped to form an integral tube bundle structure. When the catheter group 2 penetrates into the body cavity bag 11, the outer wall of the outer sleeve 24 is sealed and fixedly connected to the body cavity bag 11. Through this structural design, on the one hand, the service life of the product is extended. When the catheter group 2 penetrates into the body cavity bag 11, the sealing and fixing point only exists at the junction of the outer sleeve 24 and the body cavity bag 11, which avoids the increase in the number of junctions caused by multiple catheters penetrating into the cavity bag separately, resulting in an increased risk of leakage; on the other hand, the structure of the catheter group 2 is made more stable. Because the position of each catheter in the body cavity bag 11 needs to be relatively fixed, the outer sleeve 24 is added to play a role in preliminary positioning of the catheter, thereby preventing the balloon from failing due to external force pulling on the catheter during operation.

[0051] The upper end of the main balloon catheter 21 is located in the body cavity bag 11, and the lower end of the main balloon catheter 21 passes through the body cavity bag 11 through the outer sleeve 24 and a control valve 25 is installed near the outlet. The upper end of the side balloon catheter 22 is bifurcated to form a branch tube 1 221 and a branch tube 2 222. The upper ends of the branch tube 1 221 and the branch tube 2 222 pass through the cavity wall of the body cavity bag 11 and extend into the uterine horn bag 12 to communicate with the uterine horn bag 12. The lower end of the side balloon catheter 22 passes through the body cavity bag 11 through the outer sleeve 24 and a control valve 25 is installed near the outlet; the drainage tube 23 is installed with a control valve 25 near the interface between it and the drainage bag 231. Through this structural design, coupled with the fact that the body cavity bag 11 and the uterine horn bag 12 are not connected internally, the function of injecting / extracting physiological saline into / from the body cavity bag 11 and the uterine horn bag 12 can be realized, and the bleeding in the uterus 3 can be drained separately through the drainage tube 23, and can be individually controlled by the control valves 25 installed separately.

[0052] Preferably, if Figure 5 As shown, a concave portion 111 is provided at the lower part of the body cavity balloon 11, and anti-skid protrusions 112 are provided on the surface of the concave portion 111. In order to ensure that the body cavity balloon 11 is installed more stably in the uterus 3, the structure of the lower part of the body cavity balloon 11 conforms to the internal physiological structure of the uterus 3 at the cervical os 32, and a circle of concave portions 111 is provided. After the balloon is placed in the uterus 3, the concave portion 111 is about 2-3 cm away from the cervical os, and anti-skid protrusions 112 are provided on the surface of the concave portion 111, which are horizontally distributed on the surface of the body cavity balloon 11 in a strip shape, and are about 1-1.5 cm wide, in order to increase the friction between the body cavity balloon 11 and the wall of the uterus 3, and prevent the body cavity balloon 11 from sliding down.

[0053] Preferably, if Figure 6 As shown, a protrusion 121 is provided at the top of the uterine cornu capsule 12; due to physiological structure reasons, if the uterine cornu capsule 12 adopts a spherical structure, the top of the uterine cornu capsule 12 cannot be completely fitted with the uterine cornu 31 of the uterus 3, and the compression and hemostasis effect is not obvious. Therefore, the protrusion 121 is provided at the top of the uterine cornu capsule 12 to ensure that after the uterine cornu capsule 12 is fully unfolded, it is tightly fitted with the inner wall of the uterine cornu 31, thereby effectively playing a compression role.

[0054] Preferably, if Figure 5As shown, it also includes a plurality of pressure sensors, which are attached and installed at different positions on the surface of the balloon; wherein, a No. 1 pressure point 41 is respectively arranged on both sides of the raised portion 121 of the uterine angle capsule 12, and a pressure sensor is installed at each No. 1 pressure point 41; two No. 2 pressure points 42 are symmetrically arranged at the lower part of the body cavity capsule 11, and a pressure sensor is installed at each No. 2 pressure point 42. After the body cavity capsule 11 is unfolded, the body cavity capsule 11 is close to the wall of the uterus 3, and the close part is mainly located in the lower part of the uterus 3. The connection between the body cavity capsule 11 and the wall of the uterus 3 mainly corresponds to the lower part of the body cavity capsule 11, so a pressure sensor is arranged on each of the left and right sides here, which can monitor the intrauterine cavity pressure (uterus 3 contraction force) in real time. Two pressure sensors are arranged on each of the left and right sides of the connection between the uterine angle capsule 12 and the wall of the uterus 3, which can monitor the pressure at the uterine angle 31 (uterus 3 contraction force) in real time. The pressure sensor is connected to a controller through a communication signal, and the controller is electrically connected to an external display. The pressure sensor transmits the pressure signal to the controller, which is converted and transmitted to the display by the controller, and the pressure signal is displayed on the display screen.

[0055] Preferably, the perpendicular lines of the tangents of the two No. 1 compression points 41 at the uterine angle sac 12 have an angle β at the intersection, and the range of the β angle is 70° to 100°. Theoretically, the postpartum uterine angle is 90°, and the β angle is also 90°. If the postpartum uterus does not contract well, or the contraction is poor due to placental attachment, the uterine angle may become larger and the β angle becomes smaller, so the α angle range is set to 70° to 100°.

[0056] Preferably, the vertical lines of the tangents of the two second pressure points 42 at the body cavity bag 11 have an angle γ at the intersection, and the range of γ angle is 90°~150°. The value of this angle is affected by the contraction force of the lower uterine segment. If the lower uterine segment contracts well, the γ angle becomes smaller, otherwise the γ angle becomes larger, so the range of γ angle is set to 90°~150°

[0057] Preferably, the pressure sensor adopts a flexible film pressure sensor. In this embodiment, the Hanwei brand SI4-G soft ultra-thin pressure sensor is used, which is composed of an ultra-thin film, a conductive material and a nano pressure-sensitive layer. It has high sensitivity, a thickness of only 0.1 mm, good flexibility, can be bent freely, and has excellent mechanical properties, which can meet the use requirements.

[0058] According to the above uterine tamponade hemostatic balloon, a method for using the uterine tamponade hemostatic balloon comprises the following steps:

[0059] Step A: After vaginal delivery of the placenta, press the uterine fundus to understand the height of the uterine fundus and the contraction of the uterus, check and repair the soft birth canal, check the bleeding, and determine the bleeding site of the uterus;

[0060] Step B, inserting the uterine tamponade hemostatic balloon into the uterine cavity through the cervical os;

[0061] Step C, connecting the drainage bag 231 to the lower end of the drainage tube 23, and regularly recording the amount of uterine bleeding;

[0062] Step D, injecting normal saline into different cysts according to the bleeding sites of uterus 3;

[0063] Step E: After the balloon is placed, monitor the bleeding of the uterus 3 at any time, and remove the balloon when the bleeding stops.

[0064] Preferably, in step B, when the uterine tamponade hemostatic balloon is sent into the uterine cavity through the cervical os, the accurate placement of the balloon is required. The specific method is: slowly send the balloon into the uterine cavity from the cervical os, and stop pushing inward when you feel the push resistance, that is, the end of the drainage tube 23 just abuts against the top of the uterus 3; because the length of the upper end of the drainage tube 23 extending outside the body cavity balloon 11 is 5-8 mm, the length of the exposed section is designed in consideration of the structure of the uterus 3, so that when the end of the drainage tube 23 just abuts against the top of the uterus 3, the body cavity balloon 11 just presses on the lower segment of the uterus 3, and at the same time, the two uterine horn balloons 12 are just located at the uterine horn 31. Because the placement of the balloon is mainly based on the doctor's touch operation, when you feel that the end of the drainage tube 23 just abuts against the top of the uterus 3, it can be used as a signal that the balloon is accurately placed, providing a reference basis for the doctor's operation, and can preliminarily ensure the accurate placement of the balloon.

[0065] At the same time, with the help of B-ultrasound monitoring, check whether the position of the balloon is accurate, and adjust the position of the balloon appropriately according to the results of B-ultrasound monitoring to ensure that the body cavity balloon 11 and the two uterine horn balloons 12 are placed in the correct position in the uterus 3.

[0066] Preferably, in step D, the method of injecting physiological saline into different capsules is:

[0067] Method 1: When the bleeding site is located at the lower segment of the uterus 3, a syringe is used to inject physiological saline into the body cavity bag 11 through the main bag catheter 21, and the maximum injection volume is 800 ml. First, 350 to 400 ml are injected, and the value of the pressure sensor at the second pressure point 42, that is, the contraction force of the uterus 3, is monitored. When the contraction force of the uterus 3 reaches or approaches 150 mmHg, the water injection is stopped and the control valve 25 is closed;

[0068] Method 2: When the bleeding site is located at the uterine cornu 31, firstly, inject normal saline into the body cavity bag 11 according to the method described in method 1, and then inject normal saline into the uterine cornu 12 through the side bag catheter 22 by means of a syringe, the maximum injection volume is 200 ml, first inject 50-100 ml, and monitor the pressure sensor values ​​at the four No. 1 pressure points 41, that is, the contraction force of the uterine cornu 31. When the contraction force of the uterus 3 reaches or approaches 150 mmHg, inject 10-20 ml as appropriate, stop injecting water, and close the control valve 25; when the uterine cornu 12 gradually expands, inject a small amount of normal saline, so that the uterine cornu 12 further fits with the wall of the uterus 3 at the uterine cornu 31, so that the uterine cornu 12 fits tightly with the inner wall of the uterine cornu 31, and effectively plays a compressive role.

[0069] Method 3: When postpartum bleeding prevention is needed, use the operation described in method 2 as a preventive measure for postpartum hemorrhage.

[0070] It can be seen that the use of this balloon can flexibly select to inject water into different balloon bodies according to the actual bleeding location, adopt a targeted compression mode, or it can be used for preventive use of postpartum hemorrhage. It not only has a wide range of applications, but also makes the treatment of bleeding in different parts more targeted and the hemostatic effect will be better.

[0071] Preferably, in step E, the value of the pressure sensor installed on the surface of the balloon is used to monitor the bleeding of the uterus 3 in real time, and the data is analyzed according to the value of the pressure at each point recorded in the display, that is, the contraction force of the uterus 3 and the contraction force value of the uterine horns 31 on both sides, and the contraction force of the uterine horns 31 on both sides is compared. The contraction of the uterus 3 is analyzed by data monitoring and analysis, and the drip rate and dosage of oxytocin are adjusted in time, waiting for the body to exert its own coagulation function to form a thrombus, and guiding the next step of diagnosis and treatment; if the postpartum uterine contraction force value is close to or reaches 350mmHg, if there is not much vaginal bleeding at this time, it indicates that the uterine contraction force is good, and the drip rate of oxytocin can be adjusted to a conventional dose; if the postpartum uterine contraction force value is much less than 350mmHg, it is necessary to observe the amount of vaginal bleeding while increasing the drip rate or dosage of oxytocin. At this time, according to the situation of the pressure point value, the situation of uterine contraction force can be objectively and accurately evaluated, and the number of vaginal examinations can be reduced, the risk of infection can be reduced, the childbirth experience can be improved, and the perinatal outcome can be improved.

[0072] According to the values ​​of the subcutaneous pressure at each point recorded on the display, when the contraction force of the uterus 3 after delivery reaches 350-400 mmHg, it indicates that the contraction force of the uterus 3 is good, and the balloon can be withdrawn based on the actual amount of postpartum bleeding.

[0073] It can be seen that in this process, the pressure sensor is used to monitor the contraction force of the uterus 3 and the contraction force of the uterine horns 31 on both sides, so that the bleeding situation can be monitored in real time. Generally, the balloon is left in place for 24 hours, and the balloon is removed after 24 hours. If real-time monitoring is possible, the bleeding situation can be grasped in time without waiting for 24 hours. As long as the bleeding stops, the balloon can be withdrawn as appropriate. The treatment time is shortened and the patient's pain is reduced (if there is no recorded compression point value, the uterine contraction needs to be checked frequently, either by pressing the uterine fundus from the abdominal wall, but the accuracy is poor, or by checking and massaging the uterus from the vagina, which is very uncomfortable for the parturient and increases the chance of infection).

[0074] Furthermore, the use of pressure sensors for real-time monitoring can timely analyze the bleeding situation, facilitate timely adjustment of treatment plans, prevent delays in the disease, enable patients to receive targeted and effective treatment, and guide the next step of diagnosis and treatment to improve treatment outcomes.

[0075] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A uterine tamponade hemostatic balloon, characterized in that: The invention comprises a balloon and a catheter assembly (2), wherein the balloon comprises a body cavity balloon (11) and two uterine horn balloons (12), wherein the uterine horn balloons (12) are attached and fixed to the outer surface of the balloon and the uterine horn balloons (12) and the body cavity balloons (11) are not connected inside, and the two uterine horn balloons (12) are respectively located at the upper left corner and the upper right corner of the body cavity balloon (11), and the included angle of the central axes of the two uterine horn balloons (12) at the intersection point is α, and the range of the α angle is 90° to 120°; The catheter group (2) comprises a main sac catheter (21), a side sac catheter (22) and a drainage tube (23); the main sac catheter (21) connects the body cavity sac (11) with the injection port of an external syringe; the side sac catheter (22) connects the two uterine horn sacs (12) with the injection ports of an external syringe respectively; the drainage tube (23) penetrates the body cavity sac (11), and the upper end of the drainage tube (23) extends out of the body cavity sac (11); the lower end of the drainage tube (23) is connected to a drainage bag (231); It also includes a plurality of pressure sensors, which are attached and installed at different positions on the surface of the balloon; wherein, a No. 1 pressure point (41) is respectively arranged on both sides of the raised portion (121) of the uterine angle capsule (12), and a pressure sensor is installed at each No. 1 pressure point (41); two No. 2 pressure points (42) are symmetrically arranged at the lower part of the body cavity capsule (11), and a pressure sensor is installed at each No. 2 pressure point (42); the pressure sensor is connected to a controller through a communication signal, and the controller is electrically connected to an external display; the vertical lines of the tangents of the two No. 1 pressure points 41 at the uterine angle capsule 12 have an angle β at the intersection, and the range of the β angle is 70° to 100°; the vertical lines of the tangents of the two No. 2 pressure points 42 at the body cavity capsule 11 have an angle γ at the intersection, and the range of the γ angle is 90° to 150°; The catheter group (2) also includes an outer sleeve (24), through which the main balloon catheter (21), the side balloon catheter (22) and the drainage tube (23) are tightly wrapped to form an integral tube bundle structure; at the position where the catheter group (2) penetrates into the body cavity bag (11), the outer wall of the outer sleeve (24) is sealed and fixedly connected to the body cavity bag (11); The upper end of the main bag catheter (21) is located in the body cavity bag (11), the lower end of the main bag catheter (21) passes through the outer sleeve (24) to pass out of the body cavity bag (11) and a control valve (25) is installed near the outlet; the upper end of the side bag catheter (22) is bifurcated to form a branch tube 1 (221) and a branch tube 2 (222); the upper ends of the branch tube 1 (221) and the branch tube 2 (222) pass through the cavity wall of the body cavity bag (11) and extend into the uterine horn bag (12) to communicate with the uterine horn bag (12); the lower end of the side bag catheter (22) passes through the outer sleeve (24) to pass out of the body cavity bag (11) and a control valve (25) is installed near the outlet; the drainage tube (23) is installed with a control valve (25) near the interface between the drainage tube and the drainage bag (231); A recessed portion (111) is provided at the lower part of the body cavity sac (11), and an anti-slip protrusion (112) is provided on the surface of the recessed portion (111); and a protrusion (121) is provided at the top of the uterine horn sac (12).

2. The uterine tamponade hemostatic balloon according to claim 1, characterized in that: The length of the upper end of the drainage tube (23) extending outside the body cavity bag (11) is 8-10 mm.

Images