A disposable uterine packing balloon and its usage method

Abstract

The present invention discloses a disposable uterine tamponade balloon and a method for using the same, and relates to the technical field of medical devices. In order to solve the problem that the existing disposable uterine tamponade balloon needs to be placed in the uterine cavity of a parturient to be filled with liquid when in use, the uterus will contract reactively, and the liquid-filled balloon will be squeezed during the uterine contraction process, causing the liquid-filled balloon to slide outward. After the liquid-filled balloon slides outward, it is even more unable to support and tighten the uterine body, thereby affecting the hemostatic effect. A shunt head is installed on the top of the first filling catheter, and a liquid injection port is installed on the top of the shunt head. A first drug injection port is provided on one side of the shunt head, and a second drug injection port is provided on the other side of the shunt head. The liquid injection port, the first drug injection port, and the second drug injection port are all plug-connected with the shunt head. A first balloon is installed on the second filling catheter, a second balloon is installed on one side of the first balloon, and an inner folding ring is installed on the other side of the first balloon.

Description

Technical Field

[0001] The present invention relates to the field of medical device technology, and in particular to a disposable uterine packing balloon and a method for using the same. Background Art

[0002] At present, the treatment methods for postpartum hemorrhage include conservative drug treatment, pelvic vascular ligation, modified uterine sling suture, vascular interventional treatment and physical uterine packing compression hemostasis. Among them, physical liquid-filled balloon packing of the uterine cavity can quickly and successfully control more than 90% of severe postpartum hemorrhage induced by uterine atony. The material of the balloon catheter used is soft silicone. Due to the anatomical characteristics of the uterus, cervix, and vagina, as well as the friction inside the vagina and uterus, in order to deal with postpartum hemorrhage after vaginal delivery, it is necessary to insert the balloon catheter into the uterine cavity through the vagina. Because this hemostasis method has the advantages of simple operation, little harm to pregnant women, low cost, safety and rapidity, and rapid postoperative recovery, it is widely used in obstetrics clinic.

[0003] The existing disposable uterine tamponade balloon needs to be placed in the uterine cavity of the parturient to be filled with liquid. Since the uterus contracts reactively, the liquid-filled balloon will be squeezed during the contraction process, causing the liquid-filled balloon to slide outward. After the liquid-filled balloon slides outward, it is even more unable to support the uterine body tightly, thereby affecting the hemostatic effect. Therefore, it does not meet the existing needs. In this regard, we propose a disposable uterine tamponade balloon and a method of using it. Summary of the invention

[0004] The object of the present invention is to provide a disposable uterine tamponade balloon and a method of using the same, so as to solve the problem raised in the above-mentioned background technology that the existing disposable uterine tamponade balloon needs to be placed in the uterine cavity of the parturient to be filled with liquid during use. Since the uterus is in reactive contraction, the liquid-filled balloon will be squeezed during the contraction process, causing the liquid-filled balloon to slide outward. After sliding outward, the liquid-filled balloon cannot support the uterine body tightly, thereby affecting the hemostatic effect.

[0005] To achieve the above-mentioned purpose, the present invention provides the following technical solutions: a disposable uterine packing balloon, comprising a first filling catheter, a second filling catheter, a first balloon, a second balloon and an inner folding and pressing ring, a shunt head is installed on the top of the first filling catheter, a liquid injection port is installed on the top of the shunt head, a first drug injection port is arranged on one side of the shunt head, a second drug injection port is arranged on the other side of the shunt head, and the liquid injection port, the first drug injection port and the second drug injection port are all plug-connected with the shunt head, a first balloon is installed on the second filling catheter, a second balloon is installed on one side of the first balloon, and an inner folding and pressing ring is installed on the other side of the first balloon.

[0006] Preferably, a valve is installed on the first drug injection port, a valve is installed on the second drug injection port, and a cut-off mechanism is installed on the first filling conduit, and two cut-off mechanisms are installed.

[0007] Preferably, a plug interface is provided on the other side of the first filling conduit, a plug connector is provided on one side of the second filling conduit, and the first filling conduit is plug-connected to the plug connector on the second filling conduit through the plug interface.

[0008] Preferably, a rubber tube is provided inside the cut-off mechanism, an insertion opening is provided inside the rubber tube, and the cut-off mechanism is plug-connected with the first filling conduit through the insertion opening, and a mounting opening is provided on the cut-off mechanism.

[0009] Preferably, a cut-off ring is installed on the installation opening, fastening rings are installed around the cut-off ring, and a cut-off edge is installed on the inner wall of the cut-off ring.

[0010] Preferably, a pressing head is provided on one side of the inner folding ring, an inner folding edge is provided on the inner folding ring, a plurality of folds are provided on both sides of the inner folding edge, and the inner folding ring is slidably connected to the second filling conduit.

[0011] Preferably, a pressing ring is provided on the other side of the inner folding ring, a sliding tube is provided on one side of the pressing ring, and both the pressing ring and the sliding tube are slidably connected to the second filling conduit.

[0012] Preferably, the first filling conduit and the second filling conduit are both provided with built-in conduits, and support rings are provided between the built-in conduits and the first filling conduit and the second filling conduit, and six support rings are provided.

[0013] Preferably, the method for using the disposable uterine tamponade balloon comprises the following steps:

[0014] Step 1: Before placement, first confirm whether there is placental residue, birth canal laceration, and uterine vascular bleeding. If necessary, use ultrasound to directly explore the depth of the uterine cavity;

[0015] Step 2: During placement, the person who places the uterine tampon will remove the valve of the injection port of the disposable uterine tamponade balloon, level it with the drainage port, and insert the disposable uterine tamponade balloon through the uterine incision. The catheter will be inserted through the internal cervical os. The assistant will connect it to the external cervical os through the vagina. The balloon will be placed in place by pulling on both sides of the internal and external cervical os. The bottom of the balloon will touch the internal cervical os. The catheter will be fixed on the patient's thigh. The incisions will be closed in turn. Be careful not to puncture the balloon when suturing. Then install the valve, fill the balloon with sterile water, and fill the posterior vaginal fornix with gauze.

[0016] Step 3: After vaginal placement, the use of the hemostatic balloon in women with postpartum hemorrhage can avoid the need for laparotomy to stop bleeding. Even if it is unsuccessful, real-time monitoring of bleeding and simple operation will not cause significant delays in the next treatment measures. It can slow down the amount of bleeding during transfer to the operating room or preoperative preparation, buy time for blood matching, rescue, notification of superior doctors, and referral, and save the uterus;

[0017] Step 4: After the balloon is placed, avoid massaging the uterus or applying pressure to the uterine fundus to prevent the balloon from falling off. Continue intravenous infusion of oxytocin for 24 hours to maintain effective uterine contractions. Routinely use antibiotics for 24 hours to prevent infection. Record the amount of blood drained by the drainage tube and the height of the uterine fundus every hour. Perform a vaginal examination after the balloon is filled with liquid to confirm that the balloon is placed in the normal position.

[0018] Step 5: When withdrawal is needed, the physician will determine the timing of removing the disposable uterine tamponade balloon based on the hemostatic effect. It is usually retained for 8-24 hours, and the longest retention time is no more than 48 hours. When removing the balloon, open the valve to allow the filling liquid to flow out naturally, or use a syringe to extract the liquid. When the liquid is completely emptied, gently withdraw the disposable uterine tamponade balloon from the vagina through the cervical opening;

[0019] Step 6: After removing the balloon, monitor the vital signs and vaginal bleeding of the parturient. Release 50% of the liquid in 12 hours. If there is no continued bleeding, empty it after 12 hours and remove it. If hemostasis is unsuccessful, take more active treatment measures such as arterial embolization, arterial ligation or even hysterectomy. Real-time monitoring of bleeding volume and simple operation will not delay the next treatment plan. At the same time, leaving the balloon in place will help stabilize the condition and buy time.

[0020] Compared with the prior art, the present invention has the following beneficial effects:

[0021] 1. The present invention installs an inner folding ring on the second filling catheter, and the inner folding ring is installed on one side of the balloon. When in use, the first filling catheter and the second filling catheter are first connected. After the balloon is placed and filled, the sliding tube is slid inwardly so that the pressing ring presses the inner folding ring, so that the inner folding ring is folded inwardly from the inner folded edge and fixed, thereby playing a role of fixing and supporting the balloon, solving the problem that the existing disposable uterine tamponade balloon needs to place the liquid-filled balloon in the uterine cavity of the parturient for liquid filling when in use. Due to the reactive contraction of the uterus, the liquid-filled balloon will be squeezed during the contraction process of the uterus, causing the liquid-filled balloon to slide outward. After the liquid-filled balloon slides outward, it is even more unable to support and press against the body of the uterus, thereby affecting the hemostatic effect.

[0022] 2. By installing two balloons on the second filling catheter, the filled liquid first enters the interior of the first balloon during use to provide support and pressurize hemostasis. At the same time, the second balloon can not only serve as a backup, but also when one balloon has a poor hemostasis effect, both balloons can be used for pressurized hemostasis at the same time, thereby improving the overall use effect of the device.

[0023] 3. Two cut-off mechanisms are installed on the first filling conduit, a cut-off ring is installed on the cut-off mechanism, a fastening ring is installed on the cut-off ring, a rubber tube is installed inside the cut-off mechanism, and a cut-off edge is arranged on the inner wall of the cut-off ring. When the filling of liquid is stopped, the cut-off ring can be locked by the fastening ring so that the cut-off edge of the inner wall of the cut-off ring squeezes the rubber tube, which plays the role of squeezing and cutting off, thereby avoiding leakage of liquid. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 A schematic diagram of the steps for using the uterine tamponade balloon of the present invention;

[0025] Figure 2 This is a schematic diagram of the structure of the uterine tamponade balloon filling catheter portion of the present invention;

[0026] Figure 3 This is a schematic diagram of the structure of the uterine tamponade balloon of the present invention;

[0027] Figure 4 It is an enlarged schematic diagram of the filling conduit cutting mechanism structure of the present invention;

[0028] Figure 5 It is an enlarged schematic diagram of the internal structure of the filling conduit of the present invention;

[0029] In the figure: 1. first filling catheter; 2. liquid injection port; 3. first drug injection port; 4. second drug injection port; 5. valve; 6. diverter head; 7. cut-off mechanism; 8. plug interface; 9. second filling catheter; 10. plug connector; 11. sliding tube; 12. pressing ring; 13. first balloon; 14. second balloon; 15. pressing head; 16. inner folding ring; 17. inner folding edge; 18. rubber tube; 19. insertion port; 20. installation port; 21. fastening ring; 22. stop ring; 23. stop edge; 24. built-in catheter; 25. support ring. DETAILED DESCRIPTION

[0030] The technical solutions in the embodiments of the present invention will be described clearly and completely below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all the embodiments.

[0031] See also Figure 1-5An embodiment of the present invention is as follows: a disposable uterine packing balloon comprises a first filling catheter 1, a second filling catheter 9, a first balloon 13, a second balloon 14 and an inner folding and pressing ring 16, a shunt head 6 is installed on the top of the first filling catheter 1, a liquid injection port 2 is installed on the top of the shunt head 6, a first drug injection port 3 is arranged on one side of the shunt head 6, a second drug injection port 4 is arranged on the other side of the shunt head 6, and the liquid injection port 2, the first drug injection port 3 and the second drug injection port 4 are all plug-connected with the shunt head 6, a first balloon 13 is installed on the second filling catheter 9, a second balloon 14 is installed on one side of the first balloon 13, and an inner folding and pressing ring 16 is installed on the other side of the first balloon 13.

[0032] Furthermore, a valve 5 is installed on the first drug injection port 3, a valve 5 is installed on the second drug injection port 4, a cut-off mechanism 7 is installed on the first filling conduit 1, and two cut-off mechanisms 7 are installed. The arrangement of the valve 5 facilitates the injection of the drug solution.

[0033] Furthermore, a plug interface 8 is provided on the other side of the first filling tube 1, and a plug connector 10 is provided on one side of the second filling tube 9, and the first filling tube 1 is plug-connected with the plug connector 10 on the second filling tube 9 through the plug interface 8, so as to facilitate the connection and installation of the first filling tube 1 and the second filling tube 9.

[0034] Furthermore, a rubber tube 18 is provided inside the cut-off mechanism 7, an insertion port 19 is provided inside the rubber tube 18, and the cut-off mechanism 7 is plug-connected with the first filling conduit 1 through the insertion port 19, a mounting port 20 is provided on the cut-off mechanism 7, two cut-off mechanisms 7 are installed on the first filling conduit 1, a cut-off ring 22 is installed on the cut-off mechanism 7, a fastening ring 21 is installed on the cut-off ring 22, the rubber tube 18 is installed inside the cut-off mechanism 7, a cut-off edge 23 is provided on the inner wall of the cut-off ring 22, and when the filling of liquid is stopped, the cut-off ring 22 can be locked by using the fastening ring 21, so that the cut-off edge 23 on the inner wall of the cut-off ring 22 squeezes the rubber tube 18.

[0035] Furthermore, a cut-off ring 22 is installed on the installation opening 20, and a fastening ring 21 is installed around the cut-off ring 22. A cut-off edge 23 is installed on the inner wall of the cut-off ring 22 to play a role of squeezing and cutting off when in use to prevent leakage of liquid.

[0036] Furthermore, a pressing head 15 is provided on one side of the inner folding ring 16, and an inner folding edge 17 is provided on the inner folding ring 16. A number of folds are provided on both sides of the inner folding edge 17, and the inner folding ring 16 is slidably connected to the second filling catheter 9. The inner folding ring 16 is installed on one side of the balloon. When in use, the first filling catheter 1 and the second filling catheter 9 are first connected. After the balloon is placed and filled, the sliding tube 11 is slid inward so that the pressing ring 12 presses the inner folding ring 16, so that the inner folding ring 16 is folded inward from the inner folding edge 17 and fixed, thereby playing a role of fixing and supporting the balloon.

[0037] Furthermore, a pressing ring 12 is provided on the other side of the inner folding ring 16, and a sliding tube 11 is provided on one side of the pressing ring 12, and the pressing ring 12 and the sliding tube 11 are both slidably connected to the second filling catheter 9, which solves the problem that the existing disposable uterine tamponade balloon needs to place the liquid-filled balloon in the uterine cavity of the parturient for liquid filling when in use. Due to the reactive contraction of the uterus, the liquid-filled balloon will be squeezed during the contraction of the uterus, causing the liquid-filled balloon to slide outward. After the liquid-filled balloon slides outward, it is even more unable to support and press against the body of the uterus, thereby affecting the hemostatic effect.

[0038] Furthermore, built-in catheters 24 are installed inside the first filling catheter 1 and the second filling catheter 9, and support rings 25 are installed between the built-in catheter 24 and the first filling catheter 1 and the second filling catheter 9, and six support rings 25 are installed, which play a role of supporting and limiting the built-in catheters 24.

[0039] Furthermore, a method for using a disposable uterine tamponade balloon comprises the following steps:

[0040] Step 1: Before placement, first confirm whether there is placental residue, birth canal laceration, and uterine vascular bleeding. If necessary, use ultrasound to directly explore the depth of the uterine cavity;

[0041] Step 2: During placement, the person who places the uterine tampon will remove the valve of the injection port of the disposable uterine tamponade balloon, level it with the drainage port, and insert the disposable uterine tamponade balloon through the uterine incision. The catheter will be inserted through the internal cervical os. The assistant will connect it to the external cervical os through the vagina. The balloon will be placed in place by pulling on both sides of the internal and external cervical os. The bottom of the balloon will touch the internal cervical os. The catheter will be fixed on the patient's thigh. The incisions will be closed in turn. Be careful not to puncture the balloon when suturing. Then install the valve, fill the balloon with sterile water, and fill the posterior vaginal fornix with gauze.

[0042] Step 3: After vaginal placement, the use of the hemostatic balloon in women with postpartum hemorrhage can avoid the need for laparotomy to stop bleeding. Even if it is unsuccessful, real-time monitoring of bleeding and simple operation will not cause significant delays in the next treatment measures. It can slow down the amount of bleeding during transfer to the operating room or preoperative preparation, buy time for blood matching, rescue, notification of superior doctors, and referral, and save the uterus;

[0043] Step 4: After the balloon is placed, avoid massaging the uterus or applying pressure to the uterine fundus to prevent the balloon from falling off. Continue intravenous infusion of oxytocin for 24 hours to maintain effective uterine contractions. Routinely use antibiotics for 24 hours to prevent infection. Record the amount of blood drained by the drainage tube and the height of the uterine fundus every hour. Perform a vaginal examination after the balloon is filled with liquid to confirm that the balloon is placed in the normal position.

[0044] Step 5: When withdrawal is needed, the physician will determine the timing of removing the disposable uterine tamponade balloon based on the hemostatic effect. It is usually retained for 8-24 hours, and the longest retention time is no more than 48 hours. When removing the balloon, open the valve to allow the filling liquid to flow out naturally, or use a syringe to extract the liquid. When the liquid is completely emptied, gently withdraw the disposable uterine tamponade balloon from the vagina through the cervical opening;

[0045] Step 6: After removing the balloon, monitor the vital signs and vaginal bleeding of the parturient. Release 50% of the liquid in 12 hours. If there is no continued bleeding, empty it after 12 hours and remove it. If hemostasis is unsuccessful, take more active treatment measures such as arterial embolization, arterial ligation or even hysterectomy. Real-time monitoring of bleeding volume and simple operation will not delay the next treatment plan. At the same time, leaving the balloon in place will help stabilize the condition and buy time.

[0046] It will be apparent to those skilled in the art that the invention is not limited to the details of the exemplary embodiments described above and that the invention can be implemented in other specific forms without departing from the spirit or essential features of the invention. Therefore, the embodiments should be considered exemplary and non-limiting in all respects, and the scope of the invention is defined by the appended claims rather than the foregoing description, and it is intended that all variations falling within the meaning and scope of the equivalent elements of the claims be included in the invention. Any reference numeral in a claim should not be considered as limiting the claim to which it relates.

Claims

1. A disposable uterine tamponade balloon, comprising a first filling catheter (1), a second filling catheter (9), a first balloon (13), a second balloon (14) and an inner folding ring (16), characterized in that: A shunt head (6) is installed on the top of the first filling conduit (1), a liquid injection port (2) is installed on the top of the shunt head (6), a first drug injection port (3) is provided on one side of the shunt head (6), a second drug injection port (4) is provided on the other side of the shunt head (6), and the liquid injection port (2), the first drug injection port (3) and the second drug injection port (4) are all plug-connected to the shunt head (6), a first balloon (13) is installed on the second filling conduit (9), a second balloon (14) is installed on one side of the first balloon (13), an inner folding ring (16) is installed on the other side of the first balloon (13), an insertion interface (8) is provided on the other side of the first filling conduit (1), a plug connector (10) is provided on one side of the second filling conduit (9), and the first filling conduit (1) is connected to the second filling conduit (9) through the insertion interface (8). 9), a plug connector (10) on the inner folding ring (16) is plug-connected, a pressing head (15) is provided on one side of the inner folding ring (16), an inner folding edge (17) is provided on the inner folding ring (16), a plurality of folds are provided on both sides of the inner folding edge (17), and the inner folding ring (16) is slidably connected to the second filling conduit (9), a pressing ring (12) is provided on the other side of the inner folding ring (16), a sliding tube (11) is provided on one side of the pressing ring (12), and the pressing ring (12) and the sliding tube (11) are both slidably connected to the second filling conduit (9), the first filling conduit (1) and the second filling conduit (9) are both installed with built-in conduits (24), and support rings (25) are installed between the built-in conduits (24) and the first filling conduits (1) and the second filling conduits (9), and six support rings (25) are installed.

2. A disposable uterine tamponade balloon according to claim 1, characterized in that: The first drug injection port (3) is provided with a valve (5), the second drug injection port (4) is provided with a valve (5), the first filling conduit (1) is provided with a cut-off mechanism (7), and two cut-off mechanisms (7) are provided.

3. A disposable uterine tamponade balloon according to claim 2, characterized in that: The cut-off mechanism (7) is provided with a rubber tube (18) inside, and the rubber tube (18) is provided with an insertion opening (19) inside. The cut-off mechanism (7) is plug-connected with the first filling conduit (1) via the insertion opening (19), and the cut-off mechanism (7) is provided with a mounting opening (20).

4. A disposable uterine tamponade balloon according to claim 3, characterized in that: A cut-off ring (22) is installed on the installation opening (20), a fastening ring (21) is installed around the cut-off ring (22), and a cut-off edge (23) is installed on the inner wall of the cut-off ring (22).

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