High-precision hemostatic balloon and system

Abstract

Disclosed in the present invention are a high-precision hemostatic balloon and system, which relate to the technical field of medical devices. The high-precision hemostatic balloon is used for uterine cavity hemostasis and comprises a balloon assembly and a catheter assembly. The balloon assembly comprises an intrauterine hemostasis balloon and an intravaginal fixing balloon. The intrauterine hemostasis balloon comprises a middle balloon mainly used for compressing front and rear walls of the uterus, and left and right side balloons mainly used for compressing left and right side walls of the uterus. The three balloons form a flat inverted pear shape with a wide top and a narrow bottom, and front and rear diameters being smaller than left and right diameters. The intravaginal fixing balloon is clamped and fixed in the vaginal fornix and surrounds the cervix after expansion, and the internal cervical orifice is closed while the intrauterine hemostasis balloon is lifted. The catheter assembly is used for draining accumulated blood and performing fluid filling and drainage on the balloon assembly. By utilizing the characteristics of the vaginal fornix at the cervix ostium, the present invention provides the intravaginal fixing balloon to lift the hemostasis balloon and close the internal cervical orifice. In addition, the use of a multi-cavity hemostasis balloon improves the regional compression precision of the balloon.

Description

High precision hemostatic balloon and system TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, and in particular to a high precision hemostatic balloon and system for uterine cavity hemostasis. BACKGROUND

[0002] Gynecological and obstetric patients can suffer from heavy bleeding, for example due to trauma, miscarriage, vaginal delivery or caesarean section delivery, or due to various other causes such as placental abruption, placenta previa, placenta implantation or penetration or implantation placenta, coagulopathy, etc. Currently, the treatment methods for treating gynecological / obstetric bleeding can include blood products and / or drug intervention (such as coagulation mediators, uterine contraction agent drugs), uterine massage and compression suture, surgery, and interventional radiology surgery. Among them, the method of filling gauze into the uterus for hemostasis is an effective and rapid hemostasis method, but the preparation and filling of gauze are difficult, the pressure on the inner wall of the uterine cavity is not uniform, and a dead space is easily formed, resulting in failure of hemostasis; moreover, the surface of the gauze is rough and not smooth, and once there is a detached gauze thread, etc., the uterine environment will be contaminated, increasing the pain of the patient.

[0003] In view of the above problems, balloon catheters developed initially for other purposes, such as Foley balloon catheter and Rusch balloon catheter, are applied to uterine cavity hemostasis, and later balloon catheters developed specifically for treating postpartum hemorrhage of the uterus appeared, such as SOS Bakri tamponade balloon catheter (manufactured by Cook Medical Inc., Bloomington, IN). The Bakri tamponade balloon catheter is a balloon catheter developed specifically for treating postpartum hemorrhage of the non-injured uterus, and the structure of the hemostatic balloon is similar to that of a balloon provided at the top of a urinary catheter. After the balloon is inflated with liquid (or other fluid), it can be fixed in the uterus and resist the internal orifice of the uterine cervix, allowing blood to flow from the opening at the upper end of the balloon and then flow out from the outlet of the flow guide pipe, thereby draining the blood accumulated in the uterine cavity. On the one hand, by placing a hemostatic balloon in the uterine cavity of a bleeding puerpera, the hemostatic balloon generates a hydrostatic pressure from the uterine cavity to the outside of the uterine cavity, which is greater than the pressure of the uterine artery. The balloon filled with water directly presses on the inner wall of the lower end of the uterus, i.e. the entrance of the uterine artery, which can effectively reduce postpartum uterine bleeding. On the other hand, the balloon can also compress the blood sinuses opened at the placenta implantation site of the endometrium, further reducing uterine bleeding.

[0004] However, the balloon body of the traditional uterine cavity hemostasis balloon is usually long-cylindrical or spherical, which does not match the actual shape of the uterus. As shown in FIG. 1, the normal shape of the uterus is usually slightly flattened inverted pear-shaped, and the uterine cavity is triangular with a wide upper part and a narrow lower part. The non-pregnant period can accommodate about 5 ml, and the pregnant period can increase to 5000 ml. After the fetus and placenta are delivered, the shape of the uterine cavity is still wide at the top and narrow at the bottom, and the shape of the uterus is still larger in the transverse direction than in the front and back directions, so that the hemostasis balloon cannot well fit the fundus and both sides of the uterine cavity. At the same time, the balloon is usually placed in the middle and lower segment of the uterine cavity, or even in the lower segment and the cervical canal. It is easy to slip out because it cannot be fixed at the cervix, especially for patients with postpartum hemorrhage after vaginal delivery and cesarean section with a wide cervix, because the cervix is loose and / or the cervix is injured, it is more likely to slip out. Accordingly, in recent years, hemostasis balloons that adapt to the size and shape of the uterine cavity have also appeared, and a uterine neck cover is added to prevent the hemostasis balloon in the uterus from slipping. As an example, Chinese Patent ZL202020503679.7 discloses a uterine cavity hemostasis assembly, which comprises a hemostasis balloon, a liquid injection pipe, a uterine cavity drainage pipe and a liquid injection device. The upper end of the hemostasis balloon is inwardly recessed to form a drainage port, and a uterine neck cover is arranged below the hemostasis balloon. The side wall of the drainage port is provided with a spiral thread, the drainage port is connected with the uterine cavity drainage pipe, the uterine cavity drainage pipe passes through the hemostasis balloon and extends out from the lower end. The uterine neck cover is internally provided with an air bag and a sliding channel in the middle. The uterine cavity drainage pipe can slide in the sliding channel. The uterine neck cover is raised around after being inflated, and the middle is recessed, which can be clamped between the posterior fornix of the vagina and the medial side of the pubic arch. The uterine neck cover squeezes the inside of the cervical orifice, so that the cervical orifice tends to close. The above-mentioned scheme provides a hemostasis balloon with a shape of wide at the top and narrow at the bottom, and also provides a cervical orifice part that can be squeezed, so that the prolapsed cervical orifice is closed upward, avoiding the uterine neck cover air bag of the hemostasis balloon from slipping out of the cervical orifice. For another example, Chinese Patent ZL202121718055.8 discloses a new type of uterine and cervical hemostasis balloon, which comprises a hemostasis balloon, a drainage pipe fixedly installed on the hemostasis balloon, a ring-shaped cervical cover fixedly sleeved on the drainage pipe, a main collection ball fixedly installed at the bottom end of the drainage pipe, a liquid passage guide hole opened on the drainage pipe, a liquid injector fixedly installed on one side of the outer wall of the drainage pipe, and one end of the liquid injector is fixedly and sealingly connected with the bottom of the liquid passage guide hole, and an air inflator fixedly installed at the bottom of the cervical cover.When in use, the deflated hemostatic balloon is inserted into the uterus of a parturient woman by holding the drainage tube, and when the arc surface contact cover is slightly blocked and contacts the inner wall of the uterus, the insertion is stopped, and the upper and lower ends of the cervical cover are just pushed into the vaginal cul-de-sac and pubic arch, air is blown into the cervical cover through the air blower, so that the cervical cover is stably placed on the vaginal part of the uterine cervix; when the parturient woman bleeds or has bled, normal saline is injected into the liquid passage guide hole through the liquid injector, the normal saline is extruded from the top outlet of the liquid passage guide hole, and the hemostatic balloon is lifted, the hemostatic balloon presses the inner wall of the uterus after being lifted, presses the blood vessels of the uterine cavity wound, induces uterine contraction, and thus the purpose of hemostasis is achieved, and at the same time, the overflowing blood is extruded and filled into the two fan-shaped drainage holes and is drained out through the drainage tube. The cervical cover in the above scheme can also prevent the hemostatic balloon from falling out of the cervix after being inflated.

[0005] However, the above-mentioned existing uterine cavity hemostatic balloon has the following disadvantages: 1) The traditional uterine cavity hemostatic balloon generally adopts a single-cavity balloon, which can well compress the front and back walls of the uterus, but the compression of the lateral wall of the uterus is often insufficient, and the ascending branch of the uterine artery runs along the lateral wall of the uterus, so insufficient compression may lead to poor hemostatic effect of the hemostatic balloon. It is found in actual application that even if the single-cavity hemostatic balloon is set to have a shape of being wide at the upper part and narrow at the lower part to adapt to the shape of the uterine cavity, the single-cavity balloon still cannot meet the demand for better compression of the lateral wall area, placenta attachment area or active bleeding area of the uterus due to the inability to control the expansion area and the inflation degree of the area when the balloon is inflated. How to set the area expansion performance and the inflation degree of the area of the uterine cavity hemostatic balloon based on the shape of the uterine cavity to improve the area compression accuracy of the hemostatic balloon is a technical problem to be solved at present. Further, the area pressure of the hemostatic balloon often needs to be adjusted according to the intracavitary tissue condition / intracavitary bleeding condition of the patient to control the compression force of the balloon on certain area or areas of the uterine cavity wall, such as increasing / decreasing the compression force of a certain area at the back of the cavity wall without increasing / decreasing the compression force of other areas, but the existing hemostatic balloon cannot meet the demand for fine adjustment of the area pressure. 2) When the hemostatic balloon is used to treat postpartum hemorrhage in clinic, the uterine cavity hemostatic balloon often cannot be well sent to the fundus or upper segment of the uterine cavity. For example, the cervical orifice of some patients is tight, or the tenacity is strong, the head of the balloon is wide, the silicone material is soft, and there is no supporting structure, so it is not easy to be inserted into the uterine cavity through the cervical orifice; during the operation, if the uterine cavity is adhesed, the uterine cavity shape is abnormal (the uterus is excessively inclined forward or backward), or the uterine cavity is narrow at the body part, the balloon is not easy to be inserted into the fundus, and it is easy to be folded and slipped out. At present, in order to insert the hemostatic balloon, an oviform forceps is often used, but the oviform forceps has a limited length and is relatively thick, and when it is inserted into and out of the uterine cavity, the uterine body and the cervical canal are easily damaged, which brings great pain to the patient. SUMMARY

[0006] The present application aims at overcoming the shortcomings of the prior art and providing a high-precision hemostatic balloon and system.The high-precision hemostatic balloon provided by the present application comprises a balloon assembly and a catheter assembly, the catheter assembly is provided with the balloon assembly, the balloon assembly comprises an intrauterine hemostatic balloon and an intravaginal fixing balloon, on one hand, the intrauterine hemostatic balloon adopts a multi-cavity balloon to form a flattened inverted pear shape with a wide upper part and a narrow lower part and a smaller front-to-back diameter than a left-to-right diameter, the middle balloon is mainly used for compressing the front and back walls of the uterus, and the left and right side balloons are mainly used for compressing the left and right side walls of the uterus, and the use of the multi-cavity balloon improves the regional compression accuracy of the hemostatic balloon; on the other hand, the intravaginal fixing balloon is arranged to be clamped in the vaginal vault at the top of the vagina and wrapped around the cervix, and the intrauterine hemostatic balloon is lifted and the internal orifice of the cervix is closed at the same time.Further, the present application thickens the balloon wall between the middle balloon and the two side balloons to limit the expandability of the balloon at the thicker wall, so that the expansion of the balloon is guided to the thinner area of the balloon wall on the outside, which can promote the balloon to expand more to the outside when filled, so as to better achieve the effect that the middle balloon is mainly used for compressing the front and back walls of the uterus and the left and right side balloons are mainly used for compressing the side walls of the uterus.

[0007] To achieve the above-mentioned object, the present application provides the following technical scheme: a high-precision hemostatic balloon for uterine cavity hemostasis, comprising: a balloon assembly comprising an intrauterine hemostatic balloon and an intravaginal fixing balloon; the intrauterine hemostatic balloon comprises a middle balloon, a left side balloon and a right side balloon, the middle balloon and the left and right side balloons combine to form a flattened inverted pear shape with a wide upper part and a narrow lower part and a smaller front-to-back diameter than a left-to-right diameter, the cavities of the middle balloon and the left and right side balloons are independent of each other, the middle balloon is mainly used for compressing the front and back walls of the uterus after expansion, and the left and right side balloons are mainly used for compressing the left and right side walls of the uterus after expansion; the intravaginal fixing balloon is used to be clamped in the vaginal vault at the top of the vagina and wrapped around the cervix after expansion, and the intrauterine hemostatic balloon is lifted and the internal orifice of the cervix is closed at the same time; a catheter assembly is provided with the balloon assembly; the catheter assembly is used for draining the blood accumulated in the uterine cavity and filling and discharging fluid for the balloon assembly.

[0008] Further, the intravaginal fixing balloon is a ring-shaped balloon, the inner ring of the ring-shaped balloon matches the peripheral size of the cervix at the vaginal vault, and the body of the ring-shaped balloon matches the size of the vaginal vault; the fluid filled by the intrauterine hemostatic balloon and the intravaginal fixing balloon when expanded is a liquid.

[0009] Further, the catheter assembly comprises: a flexible drainage tube, the drainage tube distal end sequentially passes through the inner ring of the intravaginal fixation balloon, the inner cavity of the intrauterine hemostasis balloon, and then extends outside the intrauterine hemostasis balloon, the drainage tube distal end is provided with a drainage port to drain the blood accumulated in the uterine cavity, and the proximal end of the drainage tube is connected with a drainage device; an intrauterine hemostasis balloon pipeline for connecting the intermediate balloon, the left balloon and the right balloon with an external inflation device; wherein, the intermediate balloon, the left balloon and the right balloon are respectively provided with independent intermediate balloon pipeline, left balloon pipeline and right balloon pipeline, the distal end of each balloon pipeline is communicated with the inner cavity of the corresponding balloon, the proximal end of each balloon pipeline is provided with a valve to open or close the pipeline port, and the pipeline port is connected with the inflation device; and an intravaginal fixation balloon pipeline for connecting the intravaginal fixation balloon with the external inflation device, the distal end of the intravaginal fixation balloon pipeline is communicated with the inner cavity of the intravaginal fixation balloon, the proximal end of the intravaginal fixation balloon pipeline is provided with a valve to open or close the pipeline port, and the pipeline port is connected with the inflation device.

[0010] Further, the balloon wall of the intermediate balloon comprises a side balloon connecting area and a non-connecting area, the balloon wall thickness of the side balloon connecting area is greater than that of the non-connecting area, so that the intermediate balloon is more inflated in the direction of the anterior and posterior walls of the uterus when inflated and expanded to realize that the intermediate balloon is mainly used for pressing the anterior and posterior walls of the uterus; the balloon wall of the left and right side balloons comprises an intermediate balloon connecting area and a non-connecting area, the balloon wall thickness of the intermediate balloon connecting area is greater than that of the non-connecting area, so that the left and right side balloons are more inflated in the direction of the left and right sides of the uterus respectively when inflated and expanded to realize that they are mainly used for pressing the lateral walls of the uterus; wherein, the inflated left and right side balloons can effectively press the left and right lateral walls of the lower segment of the uterus to block the ascending branches of the uterine arteries.

[0011] Further, the intermediate balloon adopts a multi-cavity structure, comprising a center cavity and balloon cavity units radially distributed around the center cavity, the cavities between the balloon cavity units are independent of each other, each balloon cavity unit is communicated with the center cavity through a balloon cavity channel, and each balloon cavity unit is provided with a traction line for pressure adjustment; when the inflation fluid enters the center cavity of the intermediate balloon through the catheter assembly, it then enters the balloon cavity units through the balloon cavity channels; the center cavity can be passed through by the catheter assembly; the catheter assembly further comprises an operation cavity for the intermediate balloon operation support to enter the center cavity, and the intermediate balloon operation support adopts a tube structure; each balloon cavity unit has a distal end and a proximal end, the first end of the traction line is connected to the balloon wall at the distal end of the balloon cavity unit, the second end of the traction line penetrates through the balloon cavity channel at the proximal end of the balloon cavity unit, is introduced into the lumen of the intermediate balloon operation support through the center cavity, and then is led out from the lumen outlet of the intermediate balloon operation support; the second end of the traction line is pulled by the user or by a traction adjustment device to adjust the distal end balloon wall of each balloon cavity unit, so as to adjust the regional pressure of the uterine cavity region corresponding to the balloon cavity unit.

[0012] Further, each of the sac cavity units is provided with a traction line, the traction line is point-like traction with the sac wall at the distal end of the sac cavity unit, at this time, the sac wall at the distal end of the sac cavity unit has a thickened area, the first end of the traction line is connected with the thickened area, and the second end of the traction line is pulled to move the first end of the traction line to the direction of the central cavity during traction; or, each of the sac cavity units is provided with a plurality of traction lines, the sac wall at the distal end of the sac cavity unit is realized by the plurality of traction lines to achieve surface traction, the first ends of the plurality of traction lines are respectively connected to different directions of the sac wall at the distal end of the sac cavity unit, and the second ends of the plurality of traction lines are simultaneously pulled to simultaneously move the first ends of the plurality of traction lines to the direction of the central cavity during traction.

[0013] Further, each of the sac cavity units is further provided with a sac cavity stent capable of being filled with fluid, and the sac cavity stent forms a reinforced support between the proximal end and the distal end of the sac cavity unit after being filled with the fluid; the sac cavity stent is sequentially connected by a plurality of independent cavity segments, including a head cavity segment, a tail cavity segment and at least one intermediate cavity segment, the head cavity segment is connected to the sac wall at the distal end of the sac cavity unit, the tail cavity segment is connected to the sac wall at the proximal end of the sac cavity unit, and the intermediate cavity segment is located between the head cavity segment and the tail cavity segment and is nestedly connected; independent catheters are respectively arranged corresponding to the head cavity segment, the tail cavity segment and the intermediate cavity segment, and the head cavity segment, the tail cavity segment and the intermediate cavity segment are respectively filled with fluid through the respective catheters when filling is needed; when it is needed to reduce the pressing force of the sac cavity unit on the corresponding uterine cavity area, part of the fluid in the head cavity segment is released first.

[0014] The application further discloses a hemostatic balloon system, which comprises: a hemostatic balloon, which is the high-precision hemostatic balloon in any one of claims 1-7; and a balloon boosting device, which is detachably connected with the flexible drainage tube and used for being attached or inserted on the drainage tube to support the catheter assembly when the balloon is placed, so as to guide the intrauterine hemostatic balloon of the hemostatic balloon to be placed at the fundus or the upper segment of the uterine cavity.

[0015] Further, the system further comprises a cervical cerclage belt, which is used for horizontally cerclaging the cervix to close the internal orifice of the cervix; the cervical cerclage belt is connected on the catheter assembly and arranged corresponding to the position of the intravaginal fixed balloon; wherein the cervical cerclage belt comprises a cerclage ring and a telescopic buckle, and the telescopic buckle can adjust the tightness of the cerclage ring.

[0016] Further, the balloon boosting device is a guide tube, the guide tube is provided with a guide tube sub-cavity on the drainage tube for the insertion of the guide tube, the hardness of the guide tube is greater than that of the drainage tube, so as to improve the bending resistance and toughness of the balloon placement, and the guide tube can be separated from the drainage tube after the balloon is placed in place, so as to take out the guide tube; the guide tube is provided with a scale, which is used for indicating the position of the balloon reaching the uterine cavity.

[0017] Compared with the prior art, the high-precision hemostatic balloon provided by the application has the following advantages and positive effects: the high-precision hemostatic balloon comprises a balloon assembly and a catheter assembly, the balloon assembly is arranged on the catheter assembly, the balloon assembly comprises an intrauterine hemostatic balloon and an intravaginal fixing balloon, on one hand, the intrauterine hemostatic balloon adopts a multi-cavity balloon to form a flat inverted pear shape with a wide upper part and a narrow lower part and a smaller front-to-back diameter than a left-to-right diameter, the middle balloon is mainly used for pressing the front and back walls of the uterus, and the left and right side balloons are mainly used for pressing the left and right side walls of the uterus, and the use of the multi-cavity balloon improves the regional pressing precision of the hemostatic balloon; on the other hand, the intravaginal fixing balloon is arranged in the vaginal vault at the top of the vagina and wraps around the cervix, and the intravaginal fixing balloon is used for closing the internal orifice of the cervix while lifting the intrauterine hemostatic balloon. Further, the wall thickness between the middle balloon and the two side balloons is increased to limit the expandability of the balloons at the thicker wall part, so that the expansion of the balloon is guided to the thinner wall part of the outer side balloon wall, which can promote the balloon to expand more to the outer side when filled, so as to better achieve the effect that the middle balloon is mainly used for pressing the front and back walls of the uterus and the left and right side balloons are mainly used for pressing the side walls of the uterus.

[0018] On the other hand, the hemostatic balloon capable of adjusting the regional pressure is also provided, which can control the pressing force of the balloon on the wall of the uterine cavity in one or more regions after inflation as needed, and the fine adjustment of the regional pressure of the balloon is achieved.

[0019] The system comprising the high-precision hemostatic balloon is also provided, and the system comprises a guide tube as a balloon boosting device, at this time, the guide tube can be attached or connected to the drainage tube to improve the bending resistance and toughness of the balloon catheter when the balloon catheter is placed in the uterine cavity. After the balloon is placed in position, the guide tube can be separated from the balloon catheter to maintain the flexibility of the balloon catheter, so that the efficiency of placing the hemostatic balloon in the uterine cavity is improved, and the pain of the patient is reduced.

[0020] On the other hand, a cervical cerclage band can also be connected to the catheter assembly (preferably the drainage tube) of the hemostatic balloon, and the cervical cerclage band is used for horizontally cerclaging the cervix to close the internal orifice of the cervix. Under the double action of the cerclage band and the intravaginal fixing balloon, the hemostatic balloon can be better prevented from slipping, and the cervix can be kept or restored to the normal anatomical structure to help hemostasis, while the drainage of the uterine cavity is not affected. BRIEF DESCRIPTION OF DRAWINGS

[0021] FIG. 1 is a schematic view of the structure of the uterine cavity.

[0022] FIG. 2 is a schematic view of the structure of the high-precision hemostatic balloon provided by the embodiment of the application.

[0023] FIG. 3 is a schematic view of the arrangement of the intrauterine hemostatic balloon pipeline provided by the embodiment of the application.

[0024] Fig. 4 is a schematic diagram of the structure of the annular intra-vaginal fixing balloon according to an embodiment of the present application.

[0025] Fig. 5 is a schematic diagram of the structure of the catheter assembly according to an embodiment of the present application.

[0026] Fig. 6 is a schematic diagram of the structure of the side balloon connecting area and non-connecting area of the intermediate balloon according to an embodiment of the present application.

[0027] Fig. 7 is a schematic diagram of the structure of the intermediate balloon with a central cavity and multi-cavity unit according to an embodiment of the present application.

[0028] Fig. 8 is a schematic diagram of the A-A cross section of Fig. 7.

[0029] Fig. 9 is a schematic diagram of the planar traction structure of the cavity unit according to an embodiment of the present application.

[0030] Fig. 10 is a schematic diagram of the adjustment of the compression force of one cavity unit in Fig. 9.

[0031] Fig. 11 is a schematic diagram of the structure of the cavity support of the cavity unit according to an embodiment of the present application.

[0032] Fig. 11 is a schematic diagram of the structure of the cavity support of the cavity unit according to an embodiment of the present application. DETAILED DESCRIPTION

[0033] The high-precision hemostatic balloon and system disclosed in the present application will be further described in detail below in combination with the drawings and specific embodiments. It should be noted that the technical features or combinations of technical features described in the following embodiments should not be considered in isolation, and they can be combined with each other to achieve better technical effects. In the drawings of the following embodiments, the same reference numerals appearing in each drawing represent the same features or components and can be applied to different embodiments. Therefore, once a feature is defined in one drawing, it does not need to be further discussed in subsequent drawings.

[0034] It should be noted that the structures, proportions, sizes, etc. shown in the drawings accompanying the present specification are merely intended to cooperate with the content disclosed in the present specification, so as to be understood and read by those skilled in the art, and are not intended to limit the conditions for implementing the present application. Any modification of the structure, change of the proportional relationship, or adjustment of the size, which does not affect the effect and purpose that can be achieved by the present application, shall fall within the scope of the technology disclosed by the present application. The scope of the preferred embodiments of the present application includes additional implementations, in which the functions can be performed in a substantially simultaneous manner or in reverse order according to the functions involved, without being limited by the order described or discussed, which should be understood by those skilled in the art to which the embodiments of the present application belong.

[0035] Techniques, methods, and apparatus known to those of ordinary skill in the relevant art can not be discussed in detail herein, but should be considered as part of the patent application where appropriate. In all examples shown and discussed herein, any specific values should be interpreted as merely exemplary, and not as limiting. Thus, other examples of the exemplary embodiments can have different values.

[0036] In the description of the embodiments of the present application, " / " represents the meaning of or, and "and / or" is used to describe the association relationship of the associated objects, indicating that there can be three relationships, such as "A and / or B", indicating that there are three cases of A alone, B alone, and A and B at the same time. In the description of the embodiments of the present application, "multiple" means two or more. Embodiments

[0037] Referring to FIG. 2, a high-precision hemostatic balloon 100 for uterine cavity hemostasis is provided. The high-precision hemostatic balloon 100 adopts a balloon catheter, mainly including a balloon assembly and a catheter assembly, and the balloon assembly is arranged on the catheter assembly.

[0038] As shown in FIG. 3, the balloon assembly can include an intrauterine hemostatic balloon 111 and an intravaginal fixation balloon 112. In a specific implementation, the intrauterine hemostatic balloon and the intravaginal fixation balloon are made of expandable materials, such as natural rubber, synthetic rubber, silicone, latex, polyurethane, polyvinyl chloride, polyethylene, nylon, or any other expandable elastomer, polymer, or other material. Preferably, the intrauterine hemostatic balloon and the intravaginal fixation balloon are made of silicone, which has sufficient compliance to generally conform to the shape of the uterine cavity.

[0039] In this embodiment, the intrauterine hemostasis balloon 111 includes a middle balloon 1110, and a left balloon 1111 and a right balloon 1112 located on the left and right sides of the middle balloon 1110 respectively. The middle balloon 1110, the left balloon 1111 and the right balloon 1112 combine to form a flat inverted pear shape with a width from top to bottom being smaller than a length from front to back. The cavities of the middle balloon 1110, the left balloon 1111 and the right balloon 1112 are independent of each other, and fluid is filled into the cavities through respective filling pipes when inflation is needed. The middle balloon 1110 is mainly used to compress the front and back walls of the uterus after inflation, and the left balloon 1111 and the right balloon 1112 are mainly used to compress the left and right walls of the uterus respectively after inflation. In particular, the left lower segment compression area 1111a of the left balloon 1111 and the right lower segment compression area 1112a of the right balloon 1112 can effectively compress the ascending branch of the uterine artery of the lower segment of the uterus after inflation to effectively stop bleeding.

[0040] As a preferred typical mode, the middle balloon 1110 can adopt an oval or substantially oval balloon, the bottom of the left balloon 1111 is arranged to match the left side of the middle balloon 1110 to form a first connection area, and the bottom of the right balloon 1112 is arranged to match the right side of the middle balloon 1110 to form a second connection area. The left balloon 1111 and the right balloon 1112 can be arranged to be axially symmetrical with respect to the middle balloon 1110, and in this case, the areas of the first connection area and the second connection area are equal. Alternatively, the left balloon 1111 and the right balloon 1112 adopt relatively flat balloons, and the upper segment of the flat balloon is wider than the lower segment to form a balloon structure with a width from top to bottom being smaller than a length from front to back. The upper segment compression area can correspond to the uterine horn area, and the lower segment compression area can correspond to the ascending branch of the uterine artery area.

[0041] If the horizontal cross section of the middle balloon 1110 is evenly divided into front, back, left and right areas according to angles, preferably, the first connection area is located in the middle segment of the left area of the middle balloon, and the proportion of the first connection area with respect to the left area is not greater than 2 / 3, so that the left balloon 1111 can better compress the left side of the uterine wall when inflated; and the second connection area is located in the middle segment of the right area of the middle balloon, and the proportion of the second connection area with respect to the right area is not greater than 2 / 3, so that the right balloon 1112 can better compress the right side of the uterine wall when inflated. As an example, if the central angles of the left area and the right area in the horizontal cross section are both 90 degrees, the central angles of the first connection area and the second connection area in the horizontal cross section are preferably less than or equal to 2 / 3 of 90 degrees, i.e. less than or equal to 60 degrees.

[0042] The intravaginal fixation balloon 112 is used to be fixed in the vaginal vault at the top of the vagina and to surround the cervix (or cervix canal) after inflation, to lift the aforementioned uterine cavity hemostasis balloon and close the internal orifice of the cervix. That is, the intravaginal fixation balloon 112 needs to form a structure that can surround the cervix canal after inflation.

[0043] In a typical embodiment, in combination with the embodiments shown in Figs. 3 and 4, the intravaginal fixation balloon adopts a ring-shaped balloon, a structure similar to a swimming ring. Specifically, the ring-shaped intravaginal fixation balloon 112 can include a ring-shaped balloon body 1121, the inner cavity of the ring-shaped balloon body 1121 is used to fill fluid, and at the same time the ring-shaped balloon body 1121 forms an inner ring 1122, the inner ring 1122 of the ring-shaped balloon matches the peripheral size of the cervix at the vaginal vault, and the ring-shaped balloon body 1121 matches the size of the vaginal vault, so that the intravaginal fixation balloon can be fixed in the vaginal vault at the top of the vagina and surround the cervix after inflation. At least one opening is provided on the ring-shaped balloon body 1121 as a filling hole 1123, the filling hole 1123 is used to communicate with the intravaginal fixation balloon pipeline for the fluid in the intravaginal fixation balloon pipeline 123 to enter the inner cavity of the ring-shaped balloon body 1121, so as to inflate the ring-shaped balloon body 1121.

[0044] In this embodiment, the fluid filled by the uterine cavity hemostasis balloon 111 and the intravaginal fixation balloon 112 when inflated can be liquid or gas as needed. Preferably, the balloon is inflated by filling liquid, such as normal saline.

[0045] The catheter assembly 120 is used to drain the blood accumulated in the uterine cavity, and to fill and drain the fluid of the aforementioned balloon assembly.

[0046] In this embodiment, referring to Fig. 5, the catheter assembly 120 can specifically include a flexible drainage tube 121, a uterine cavity hemostasis balloon pipeline 122 and an intravaginal fixation balloon pipeline 123.

[0047] The distal end of the flexible drainage tube 121 successively passes through the inner ring 1122 of the intravaginal fixation balloon 112 and the inner cavity of the uterine cavity hemostasis balloon 111 and then extends out of the uterine cavity hemostasis balloon to drain the blood accumulated in the uterine cavity, and the distal end of the drainage tube is provided with a drainage port 1211. The proximal end of the drainage tube can be connected to a drainage device. Preferably, the length of the drainage tube extending out of the uterine cavity hemostasis balloon is 5-15 mm.

[0048] The uterine cavity hemostasis balloon pipeline 122 can be independently provided or attached to the aforementioned drainage tube 121. Preferably, the uterine cavity hemostasis balloon pipeline 122 is attached to the aforementioned drainage tube 121, and at this time the uterine cavity hemostasis balloon pipeline can be provided with a lumen on the drainage tube 121.

[0049] The intrauterine hemostasis balloon conduit 122 is used to communicate the middle balloon 1110, the left balloon 1111 and the right balloon 1112 with the external inflation device 150. Among them, the middle balloon 1110, the left balloon 1111 and the right balloon 1112 can be respectively provided with independent middle balloon conduit, left balloon conduit and right balloon conduit, the distal end of each balloon conduit communicates with the inner cavity of the corresponding balloon, and the proximal end of each balloon conduit can be provided with a valve to open or close the conduit port, and each conduit port is connected with the aforementioned inflation device. When the liquid needs to be inflated, the valve is opened (which can be manually opened, or the valve can be opened by electric control, at this time the valve uses electric control valve), and then the liquid is input into the aforementioned balloon conduit through the inflation device, and the liquid enters the corresponding balloon through the balloon conduit to make the balloon expand. After the balloon is expanded to the position, the valve is closed to seal the conduit port, and then the inflation device can be removed. When the balloon needs to be taken out later, the liquid in the intrauterine hemostasis balloon should be discharged first, at this time, the conduit port of the balloon conduit can be connected with the liquid collecting bag for collecting liquid, and the valve is opened to open the conduit port, and the liquid in the balloon is discharged into the liquid collecting bag through the balloon conduit.

[0050] The intravaginal fixation balloon conduit 123 can be independently provided or attached to the aforementioned drainage tube 121. Preferably, the intravaginal fixation balloon conduit 123 is attached to the aforementioned drainage tube 121, and at this time, the intravaginal fixation balloon conduit sub-cavity can be provided on the drainage tube 121.

[0051] The intravaginal fixation balloon conduit 123 is used to communicate the intravaginal fixation balloon 112 with the external inflation device 150, the distal end of the intravaginal fixation balloon conduit 123 communicates with the inner cavity of the intravaginal fixation balloon 112, and the proximal end of the intravaginal fixation balloon conduit 123 can be provided with a valve to open or close the conduit port, and the conduit port is connected with the aforementioned inflation device 150. When the liquid needs to be inflated, the valve is opened (which can be manually opened, or the valve can be opened by electric control, at this time the valve uses electric control valve), and then the liquid is input into the aforementioned intravaginal fixation balloon conduit 123 through the inflation device, and the liquid enters the intravaginal fixation balloon 112 through the intravaginal fixation balloon conduit 123 to make the intravaginal fixation balloon expand. After the balloon is expanded to the position, the valve is closed to seal the conduit port, and then the inflation device can be removed. When the balloon needs to be taken out later, the liquid in the intrauterine hemostasis balloon 111 is discharged, and then the liquid in the intravaginal fixation balloon 112 is discharged. At this time, the conduit port of the intravaginal fixation balloon conduit can be connected with the liquid collecting bag for collecting liquid, and the valve is opened to open the conduit port, and the liquid in the intravaginal fixation balloon is discharged into the liquid collecting bag through the balloon conduit.

[0052] More preferably, by using the expansion characteristics of the balloon, the balloon wall of the balloon in the embodiment can include a thickening area (thicker balloon wall) to guide the balloon to expand more in the area where the balloon wall is thinner.

[0053] Specifically, referring to Fig. 6, the balloon wall of the middle balloon 111 can include a side balloon connecting area 111a and a non-connecting area 111b. The balloon wall thickness of the side balloon connecting area 111a is greater than that of the non-connecting area 111b, so that the middle balloon expands more in the direction of the anterior and posterior walls of the uterus when inflated to achieve the purpose of mainly pressing the anterior and posterior walls of the uterus.

[0054] In addition, the balloon wall of the left and right side balloons can include a middle balloon connecting area and a non-connecting area. The balloon wall thickness of the middle balloon connecting area is greater than that of the non-connecting area, so that the left and right side balloons expand more in the direction of the left and right sides of the uterus respectively when inflated to achieve the purpose of mainly pressing the side walls of the uterus. In particular, the left and right side balloons can effectively press the left and right side walls of the lower uterine segment after expansion, thereby directly blocking the ascending branches of the uterine arteries and effectively stopping bleeding.

[0055] In this way, by thickening the balloon wall of the connecting area to limit the expandability of the balloon at the connecting area, the expansion of the balloon is guided to the non-connecting area of the balloon wall, and the balloon exhibits more obvious expansion of the non-connecting area of the balloon when inflated. After using the above scheme, the intrauterine hemostasis balloon expands more to the outside when inflated, the middle balloon can better press the anterior and posterior walls of the uterus, and the left and right side balloons can better press the left and right side walls of the uterus to press the ascending branches of the uterine arteries, thereby effectively solving the problem of poor hemostasis effect of the existing hemostasis balloon on the side walls of the uterus.

[0056] In another embodiment of the present embodiment, a force-adjustable hemostasis balloon is also provided to more finely adjust the regional pressure of the hemostasis balloon.

[0057] At this time, the middle balloon adopts a multi-cavity structure, including a central cavity and a plurality of balloon cavity units radially distributed around the central cavity. The cavities between the balloon cavity units are independent of each other, each balloon cavity unit is in communication with the aforementioned central cavity through a balloon cavity channel, and a traction line is arranged in each balloon cavity unit as a force adjustment line of the balloon cavity unit. At this time, the balloon cavity unit forms a force adjustment unit of the hemostasis balloon. When the inflation fluid enters the central cavity of the middle balloon through the catheter assembly, it then enters each balloon cavity unit through the balloon cavity channel. At the same time, the central cavity can be passed through by the catheter assembly.

[0058] In a specific implementation, the central cavity 1110a of the intermediate balloon 1110 can be a cylindrical cavity or a spherical cavity. When the central cavity 1110a is a cylindrical cavity, a plurality of balloon cavity units are arranged around the central cavity in the circumferential direction of the central cavity, and the central cavity can be passed through by a catheter assembly to extend outside the uterine cavity hemostasis balloon. When the central cavity 1110a is a spherical cavity, a plurality of balloon cavity units are distributed around the central cavity in the spherical surface of the central cavity. In this case, the upper and lower parts of the central cavity 1110a can be reserved for catheter passage.

[0059] In addition, in this embodiment, the number of balloon cavity units around the central cavity 1110a can be set according to the accuracy requirements of regional control. For example, according to the pressure regulation requirements of the anterior, posterior, left and right positions of the uterine cavity, the number of balloon cavity units can be four to correspond to the regulation of the anterior, posterior, left and right positions of the body cavity. For example, according to the pressure regulation requirements of the right upper, right lower, left upper and left lower positions of the uterine cavity, the number of balloon cavity units can be four to correspond to the regulation of the right upper, right lower, left upper and left lower positions of the body cavity. Of course, according to the division accuracy of the region, the number of balloon cavity units can be set to be more, such as six, eight, etc.

[0060] As an example of a typical way, the following describes this embodiment in detail with the central cavity 1110a being a cylindrical cavity.

[0061] Referring to FIGS. 7 and 8, the central cavity 1110a of the intermediate balloon 1110 is a cylindrical cavity that penetrates the intermediate balloon. The cylindrical cavity has an axial direction, a radial direction and a circumferential direction. The balloon cavity units 1110b are arranged in the circumferential direction of the central cavity 1110a, and a plurality of balloon cavity units are distributed radially around the central cavity 1110a, as shown in FIG. 8. In this case, each balloon cavity unit 1110b includes a distal end and a proximal end relative to the central cavity 1110a. The distal end P1 of the balloon cavity unit is away from the central cavity 1110a, and the proximal end P2 of the balloon cavity unit is close to the central cavity 1110a. The proximal end P2 of the balloon cavity unit 1110b is connected to the central cavity 1110a. In this case, for each balloon cavity unit 1110b, the top of the balloon cavity unit 1110b is connected to the top of the central cavity 1110a in the axial direction of the cylindrical cavity, and the bottom of the balloon cavity unit 1110b is connected to the bottom of the central cavity 1110a.

[0062] The catheter assembly further includes an operating cavity for the intermediate balloon operating support 160 to enter the aforementioned central cavity 1110a. The operating cavity can be provided on one side of the drainage tube, and the distal end of the operating cavity is located in the central cavity. The intermediate balloon operating support 160 adopts a hollow tube structure, which can accommodate a traction line and has a certain hardness to serve as a support when the balloon catheter adjusts the pressure.

[0063] The traction line 1110d is a force adjustment line of the balloon cavity unit, the first end of which is connected to the balloon wall at the distal end P1 of the balloon cavity unit, and the second end of the traction line 1110d enters the central cavity 1110a after passing through the balloon cavity channel 1110c at the proximal end P2 of the balloon cavity unit, and then is introduced into the lumen of the intermediate balloon operating support 160, and then is drawn out to the outside from the lumen outlet at the lower end of the intermediate balloon operating support 160.

[0064] When the pressure of the region of the balloon needs to be adjusted, the user can hold the proximal end of the intermediate balloon operating support 160, and extend the distal end of the intermediate balloon operating support 160 into the preset position of the central cavity through the operation cavity. After the distal end is extended to the position, the user can adjust the pressure of the region as needed, and pull the distal balloon wall of the corresponding balloon cavity unit through the traction line. When the traction line is pulled, the intermediate balloon operating support supports the catheter assembly, and maintains the position of the catheter assembly in the human body unchanged or substantially unchanged.

[0065] The traction of the traction line can be manual or electric.

[0066] When the manual mode is adopted, the user can adjust the distal balloon wall of each balloon cavity unit by pulling the second end of the drawn-out traction line 1110d, so as to adjust the regional pressure of the uterine cavity region corresponding to the balloon cavity unit. At this time, preferably, different visual marks are provided for the traction lines of the balloon cavity units of different regions to facilitate the user to intuitively distinguish the regions corresponding to the traction lines. For example, the traction lines can adopt different colors.

[0067] When the electric mode is adopted, a traction adjustment device can be installed at the lower end of the intermediate balloon operating support 160, and the second end of the traction line 1110d is connected to the traction adjustment device after being drawn out through the lumen outlet. For each balloon cavity unit, a traction operation key or a traction operation area can be provided on the traction adjustment device. When the user triggers the traction operation key or the traction operation area of a balloon cavity unit, the traction adjustment device controls the second end of the traction line of the balloon cavity unit to be wound to pull the distal balloon wall of the balloon cavity unit, so as to adjust the regional pressure of the uterine cavity region corresponding to the balloon cavity unit.

[0068] As an example but not limitation, taking the middle balloon including 4 balloon cavity units as an example, the traction adjustment device can include a shell, and a controller and 4 winding discs arranged in the shell, the second end of the traction line of each balloon cavity unit can be fixed on the rotating shaft of the corresponding winding disc; an electric motor is arranged on the winding disc as a rotating driver to drive the rotating shaft of the winding disc to rotate forward or reverse, so as to realize the winding or unwinding. The control circuit of the electric motor is connected with the controller and receives the control of the controller. Four button areas are further arranged on the shell to correspond to the adjustment of the four balloon cavity units respectively, and each button area can include at least two buttons to correspond to the winding operation and the unwinding operation of the traction line respectively.

[0069] When it is needed to adjust the pressure of a certain region of the balloon, the user triggers the winding button of the corresponding balloon cavity unit through the button area, and the controller controls the electric motor of the corresponding winding disc to start according to the triggered winding button, and the rotating shaft of the winding disc rotates forward to wind, slowly pulls the traction line to pull the distal balloon wall of the balloon cavity unit, and when the regional pressure meets the requirement, the user can trigger the winding button again to stop winding. When the regional traction is excessive, the user can also trigger the unwinding button of the aforementioned balloon cavity unit to control unwinding, so as to flexibly adjust the pressure of the region to meet the needs. The automatic winding and unwinding control of the winding disc can refer to the automatic winding disc / winding machine in the prior art, which belongs to the prior art and will not be described here.

[0070] In this embodiment, one traction line can be arranged in each balloon cavity unit, and the traction line is point-like traction with the balloon wall at the distal end of the balloon cavity unit. At this time, preferably, the balloon wall at the distal end of the balloon cavity unit has a thickened area, and the first end of the traction line is connected to the thickened area.

[0071] In another embodiment of the present embodiment, the traction of the balloon cavity unit can also be planar traction, as shown in FIG. 9. At this time, a plurality of traction lines can be arranged in each balloon cavity unit, and the planar traction is realized by the plurality of traction lines and the balloon wall at the distal end P1 of the balloon cavity unit, the first end of the plurality of traction lines is respectively connected to different positions of the balloon wall at the distal end P1 of the balloon cavity unit to form a plane, and the second end of the plurality of traction lines is pulled by the user at the same time. Optionally, the second ends of the plurality of traction lines are concentrated together to form a concentrated end, and the user pulls the concentrated end to realize the simultaneous traction of the second ends of the plurality of traction lines. As shown in FIG. 10, an example is shown that after a certain balloon cavity unit is pulled, the balloon wall 110c of the hemostatic balloon and the uterine cavity wall form a gap 200. It needs to be explained that the above-mentioned gap 200 is not necessary when adjusting the regional pressure, for example, when reducing the regional pressure at the distal end of the balloon cavity unit, the balloon wall 110c of the hemostatic balloon and the uterine cavity wall can still maintain contact.

[0072] Referring to FIG. 11, in the embodiment, each of the cavity units can be provided with a cavity support 1110e capable of being filled with fluid, which forms a support between the proximal end P2 and the distal end P1 of the cavity unit after being filled with fluid.

[0073] Preferably, the cavity support 1110e is sequentially connected by a plurality of independent closed cavities, which can include a head cavity section, a tail cavity section and at least one intermediate cavity section, the head cavity section is connected to the cavity wall of the distal end P1 of the cavity unit, the tail cavity section is connected to the cavity wall of the proximal end P2 of the cavity unit, and the intermediate cavity section is located between the head cavity section and the tail cavity section and is nestedly connected, and independent conduits are respectively arranged corresponding to the head cavity section, the tail cavity section and the intermediate cavity section. When filling is required, the head cavity section, the tail cavity section and the intermediate cavity section are respectively filled with fluid through the respective conduits.

[0074] When it is necessary to reduce the pressure of the cavity unit on the corresponding uterine cavity area, part of the fluid in the head cavity section can be released to reduce the pressure of the cavity wall at the distal end of the cavity unit, and at this time, the tail cavity section and the intermediate cavity section remain filled to better support the cavity unit.

[0075] More advantageously, when the hemostatic balloon is to be removed, in order to avoid the rapid contraction of the balloon body causing discomfort to the patient, the fluid in the cavity support can be released to gradually reduce the pressure of each cavity unit, and then the fluid in the central cavity is released, at this time, the fluid in other areas of the cavity unit also enters the central cavity through the cavity channel, and then is released through the central cavity.

[0076] Optionally, a pressure sensor can be arranged in each cavity of the intrauterine hemostatic balloon and the intravaginal fixing balloon to measure the internal pressure of the pressurized balloon and monitor the pressure of the pressurized balloon on the cavity wall in real time. Specifically, the pressure measuring structure can pass through the stent and be inserted into the interior of the pressurized balloon, and after being filled with fluid, the internal pressure of the pressurized balloon is monitored.

[0077] Correspondingly, a display mechanism for displaying the pressure value detected by the pressure sensor can be arranged on the proximal end of the conduit assembly, so that the user can view the monitored pressure signal.

[0078] Another embodiment of the present application further discloses a hemostatic balloon system. The system comprises a hemostatic balloon and a balloon boosting device.

[0079] The hemostatic balloon is the high-precision hemostatic balloon as described above, and the conduit assembly of the high-precision hemostatic balloon is a flexible conduit assembly.

[0080] The balloon boosting device is detachably connected with the flexible conduit assembly, and is used for being attached or inserted on the flexible conduit assembly to support the conduit assembly when the balloon is placed, so as to guide the intrauterine hemostatic balloon of the aforementioned hemostatic balloon to be placed at the fundus or the upper segment of the uterine cavity.

[0081] Specifically, the balloon boosting device is a guide tube, and a guide tube sub-cavity can be arranged on the drainage tube of the catheter assembly for the insertion of the guide tube. The hardness of the guide tube is greater than that of the drainage tube of the catheter assembly, so as to improve the bending resistance and toughness of the balloon catheter placement. After the balloon is placed in position, the guide tube can be separated from the catheter assembly to remove the guide tube.

[0082] Preferably, a scale is arranged on the guide tube to indicate the position of the balloon reaching the uterine cavity.

[0083] In this embodiment, the guide tube attached or inserted on the drainage tube is used as a support to resist bending when the balloon catheter is placed, facilitating the placement of the balloon catheter. After the balloon is placed in position, the guide tube can be separated from the drainage tube to remove the guide tube. The guide tube makes the placement of the balloon no longer need the help of forceps, tweezers and other tools, and the placement operation of the balloon is faster and more accurate, which not only reduces the work of medical staff, but also further reduces the discomfort of patients. At the same time, since the guide tube can be flexibly placed or removed, the balloon catheter can maintain the original softness, and the structure is simple and practical.

[0084] In another embodiment of the present embodiment, the hemostatic balloon system can further include a cervical cerclage band, such as a wide nylon band, which is used to horizontally cerclage the cervix to close the internal cervical orifice.

[0085] Specifically, the cervical cerclage band is connected to the catheter assembly (such as the drainage tube) of the hemostatic balloon and is arranged corresponding to the position of the intravaginal fixed balloon. After the hemostatic balloon is placed in the uterine cavity, it is filled with an appropriate amount of liquid to ensure that the balloon is located at the upper segment of the uterine cavity or the uterine fundus position, and then the cervical cerclage band is tightly wrapped around the vault of the vagina as close to the internal cervical orifice as possible to prevent the hemostatic balloon from slipping off, and then the hemostatic balloon is continuously inflated until it completely fits the uterine cavity. By directly wrapping the cervical cerclage band around the cervix, the damage to the cervix is reduced. At the same time, for patients with postpartum hemorrhage after vaginal delivery, such as those with cervical laceration, the cervical cerclage band can stop bleeding without suturing the cervix.

[0086] Preferably, the cervical cerclage band includes a cerclage ring and a telescopic buckle, and the telescopic buckle can adjust the tightness of the cerclage ring.

[0087] Specifically, the telescopic buckle may include a housing with an engaging through-hole that extends laterally through the interior of the housing. One end of a loop is fixedly connected to the housing of the telescopic buckle, and the other end of the loop extends through the engaging through-hole. A rack that engages with the cable tie is connected to the bottom surface of the inner wall of the engaging through-hole. A top groove is formed in the center of the top surface of the inner wall of the engaging through-hole, and a compression block for limiting and fixing the cable tie is provided at the lower end of the top groove. After the cable tie is adjusted to the correct position, the compression block compresses the cable tie to restrict its movement. When it is necessary to release the cable tie, the compression block is pulled up to release the compression, allowing the cable tie to move freely in the engaging through-hole, thereby adjusting the tightness of the cable tie.

[0088] During use, after placing the uninflated intrauterine hemostatic balloon into the uterine cavity, inflate it with an appropriate amount of fluid to ensure the balloon is positioned in the upper segment or fundus of the uterus. Then, ligate the cervix once inside the vagina, close to the fornix and as close as possible to the level of the internal cervical os, to prevent the intrauterine hemostatic balloon from slipping out. Continue to inflate the intrauterine hemostatic balloon until it is completely fitted into the uterine cavity. The ligation band is simply wrapped around the cervix and tied without sutures, so it will not damage the cervix. Subsequently, inflate the vaginal fixation balloon to secure it within the vaginal fornix. The vaginal fixation balloon lifts the intrauterine hemostatic balloon and further strengthens the closure of the internal cervical os by the ligation band. Under the dual action of the ligation band and the vaginal fixation balloon, the internal cervical os is better closed, thus preventing the intrauterine hemostatic balloon from slipping out. It also helps maintain or restore the normal anatomical structure of the cervix, aiding in hemostasis, while not affecting the drainage of blood accumulated in the uterine cavity.

[0089] When removing the hemostatic balloon, first release the fluid from the hemostatic balloon in the uterine cavity, then release the fluid from the balloon in the vagina, and finally remove the cervical ligature.

[0090] Other technical features are described in the preceding embodiments and will not be repeated here.

[0091] In the above description, the disclosure of this invention is not intended to limit itself to these aspects. Rather, within the scope of the objectives of this disclosure, components can be selectively and operationally combined in any number. Furthermore, terms such as “comprising,” “encompassing,” and “having” should be interpreted by default as inclusive or open-ended, rather than exclusive or closed, unless explicitly defined as such. All technical, scientific, or other terms are to be understood by those skilled in the art, unless defined as such. Public terms found in dictionaries should not be interpreted in the context of the relevant technical documents in an overly idealistic or impractical manner, unless explicitly defined as such in this disclosure. Any modifications or alterations made by those skilled in the art based on the foregoing disclosure are within the scope of the claims.

Claims

1. A high-precision hemostatic balloon for uterine cavity hemostasis, characterized in that The application relates to a balloon assembly and a catheter assembly. The balloon assembly comprises an intrauterine hemostasis balloon and a vaginal fixation balloon; the intrauterine hemostasis balloon comprises a middle balloon, a left balloon and a right balloon, and the middle balloon and the left and right balloons are combined to form a flat inverted pear shape with a wide upper part and a narrow lower part and a smaller front-to-back diameter than a left-to-right diameter; the cavities of the middle balloon and the left and right balloons are independent of each other; the middle balloon is mainly used for pressing the front and back walls of the uterus after being inflated; the left and right balloons are mainly used for pressing the left and right walls of the uterus after being inflated; the vaginal fixation balloon is used for being clamped in the vaginal vault at the top of the vagina and wrapping around the cervix after being inflated, thereby lifting the intrauterine hemostasis balloon and closing the internal orifice of the cervix. The catheter assembly is provided with the balloon assembly; the catheter assembly is used for draining blood accumulated in the uterine cavity and inflating and deflating the balloon assembly.

2. The high-precision hemostatic balloon of claim 1, wherein: The vaginal fixation balloon is a ring-shaped balloon, the inner ring of the ring-shaped balloon matches the peripheral size of the cervix at the vaginal vault, and the body of the ring-shaped balloon matches the size of the vaginal vault. The intrauterine hemostasis balloon and the vaginal fixation balloon are inflated by liquid.

3. The high-precision hemostatic balloon of claim 2, wherein, The catheter assembly comprises: a flexible drainage tube, the distal end of the drainage tube is sequentially inserted through the inner ring of the vaginal fixation balloon and the cavity of the intrauterine hemostasis balloon and then extends out of the intrauterine hemostasis balloon, the distal end of the drainage tube is provided with a drainage port for draining blood accumulated in the uterine cavity, and the proximal end of the drainage tube is connected with a drainage device; an intrauterine hemostasis balloon pipeline for connecting the middle balloon, the left balloon and the right balloon with an external inflation device; the middle balloon, the left balloon and the right balloon are respectively provided with independent middle balloon pipeline, left balloon pipeline and right balloon pipeline, the distal ends of the pipelines are connected with the cavities of the corresponding balloons, the proximal ends of the pipelines are provided with valves for opening or closing the pipeline ports, and the pipeline ports are connected with the inflation device; a vaginal fixation balloon pipeline for connecting the vaginal fixation balloon with the external inflation device, the distal end of the vaginal fixation balloon pipeline is connected with the cavity of the vaginal fixation balloon, the proximal end of the vaginal fixation balloon pipeline is provided with a valve for opening or closing the pipeline port, and the pipeline port is connected with the inflation device.

4. The high-precision hemostatic balloon according to any one of claims 1-3, wherein: The balloon wall of the middle balloon comprises a side balloon connecting area and a non-connecting area, the balloon wall thickness of the side balloon connecting area is greater than that of the non-connecting area, so that the middle balloon is more inflated towards the front and back walls of the uterus during inflation and expansion, thereby realizing that the middle balloon is mainly used for pressing the front and back walls of the uterus. The balloon wall of the left and right balloons comprises a middle balloon connecting area and a non-connecting area, the balloon wall thickness of the middle balloon connecting area is greater than that of the non-connecting area, so that the left and right balloons are more inflated towards the left and right walls of the uterus respectively during inflation and expansion, thereby realizing that the left and right balloons are mainly used for pressing the side walls of the uterus; the inflated left and right balloons can effectively press the left and right walls of the lower segment of the uterus to block the ascending branches of the uterine arteries.

5. The high-precision hemostatic balloon according to any one of claims 1-3, wherein: The intermediate balloon adopts a multi-cavity structure, including a center cavity and balloon cavity units radially distributed around the center cavity, the cavities between the balloon cavity units are independent of each other, each balloon cavity unit is in communication with the center cavity through a balloon cavity channel, and a traction line for pressure adjustment is arranged in each balloon cavity unit; when the fluid is filled, the fluid enters the center cavity of the intermediate balloon through the catheter assembly, and then enters each balloon cavity unit through the balloon cavity channel; The center cavity can pass through the catheter assembly; the catheter assembly further includes an operation cavity for the intermediate balloon operation support to enter the center cavity, and the intermediate balloon operation support adopts a tube structure; Each balloon cavity unit has a distal end and a proximal end, a first end of the traction line is connected to the balloon wall at the distal end of the balloon cavity unit, a second end of the traction line is introduced into the lumen of the intermediate balloon operation support after penetrating through the balloon cavity channel at the proximal end of the balloon cavity unit and then passing through the center cavity, and then the second end of the traction line is drawn out from the outlet of the lumen of the intermediate balloon operation support; the region pressure of the uterine cavity region corresponding to each balloon cavity unit is adjusted by pulling the second end of the traction line by a user or by a traction adjustment device to adjust the distal balloon wall of each balloon cavity unit.

6. The high-precision hemostatic balloon of claim 5, wherein: A traction line is arranged in each balloon cavity unit, the traction line and the balloon wall at the distal end of the balloon cavity unit are point-like traction, at this time, the balloon wall at the distal end of the balloon cavity unit has a thickened region, the first end of the traction line is connected to the thickened region, and the second end of the traction line is pulled during traction to move the first end of the traction line to the center cavity; Alternatively, a plurality of traction lines are arranged in each balloon cavity unit, the balloon wall at the distal end of the balloon cavity unit is surface-like traction by the plurality of traction lines, the first ends of the plurality of traction lines are respectively connected to different directions of the balloon wall at the distal end of the balloon cavity unit, and the second ends of the plurality of traction lines are simultaneously pulled during traction to simultaneously move the first ends of the plurality of traction lines to the center cavity.

7. The high-precision hemostatic balloon of claim 5 or 6, wherein: A balloon cavity support capable of being filled with fluid is further arranged in each balloon cavity unit, the balloon cavity support forms a reinforced support between the proximal end and the distal end of the balloon cavity unit after being filled with fluid; The balloon cavity support is sequentially connected by a plurality of independent cavity segments, including a head cavity segment, a tail cavity segment and at least one intermediate cavity segment, the head cavity segment is connected to the balloon wall at the distal end of the balloon cavity unit, the tail cavity segment is connected to the balloon wall at the proximal end of the balloon cavity unit, and the intermediate cavity segment is located between the head cavity segment and the tail cavity segment and is nestedly connected; independent catheters corresponding to the head cavity segment, the tail cavity segment and the intermediate cavity segment are respectively arranged, and the head cavity segment, the tail cavity segment and the intermediate cavity segment are respectively filled with fluid through the respective catheters when filling is needed; when it is needed to reduce the pressing force of the balloon cavity unit on the corresponding uterine cavity region, part of the fluid in the head cavity segment is released first.

8. A hemostatic balloon system characterized by It comprises: A hemostatic balloon, the hemostatic balloon is the high-precision hemostatic balloon of any one of claims 1-7, and the catheter assembly of the high-precision hemostatic balloon is a flexible catheter assembly; A balloon boosting device which is detachably connected with the flexible catheter assembly, is used for being attached or inserted on the flexible catheter assembly to support the catheter assembly when the balloon is placed, thereby guiding the intrauterine hemostatic balloon of the hemostatic balloon to be placed at the fundus or the upper segment of the uterine cavity.

9. The hemostatic balloon system of claim 8, wherein: Also included is a cervical cerclage band for horizontally cerclaging the cervix to close the internal cervical orifice; the cervical cerclage band is connected to the catheter assembly, corresponding to the position of the intravaginal fixation balloon; The cervical cerclage band comprises a cerclage ring and a stretch buckle, and the stretch buckle can adjust the tightness of the cerclage ring.

10. The hemostatic balloon system of claim 8 or 9, wherein: The balloon boosting device is a guide tube, and a guide tube sub-cavity is arranged on the catheter assembly for inserting the guide tube. The hardness of the guide tube is greater than the hardness of the catheter assembly to improve the bending resistance and toughness of the balloon placement. After the balloon is placed in position, the guide tube can be separated from the catheter assembly to remove the guide tube. A scale is arranged on the guide tube to indicate the position of the balloon reaching the uterine cavity.

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