Device for treating metrorrhagia

Abstract

The embodiment of the invention discloses a device for treating metrorrhagia. All the components act synergistically to improve the treatment effect. The balloon is of a multi-layer structure, can be easily placed without being inflated, and is matched with a uterine cavity to assist hemostasis after being inflated. The shape memory supporting piece for fixing the fins stabilizes the position of the balloon according to the temperature change. The inflation tube connecting plug and the balloon connecting assembly facilitate rapid establishment of a fluid channel and help medical care to accurately control the fluid amount and pressure of the balloon. An image acquisition part in the visualization assembly can acquire images in the uterus, medical care can master conditions through multi-degree-of-freedom adjustment and information processing functions, and a buffer part guarantees monitoring stability. The pressure sensing and liquid releasing assembly can release a procoagulant solution when encountering large pressure, and cooperative hemostasis is achieved in combination with balloon compression. All the components are in close linkage, defects of an existing treatment technology are effectively overcome, and operation is convenient and efficient.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a device for treating uterine bleeding. Background Art

[0002] Uterine bleeding is a common disease in obstetrics and gynecology, which can be caused by a variety of reasons, such as postpartum uterine atony, uterine trauma, uterine fibroids, endometrial lesions, etc. If severe uterine bleeding is not promptly and effectively controlled, it may lead to life-threatening conditions such as hemorrhagic shock in the parturient, and will also have long-term adverse effects on women's reproductive health.

[0003] In the existing field of uterine bleeding treatment technology, commonly used treatment methods include drug therapy, uterine massage, and uterine artery embolization. Drug therapy mainly uses drugs such as uterotonics to promote uterine contraction and reduce bleeding, but in some cases, such as when uterine contraction weakness is more severe or there are structural uterine lesions, the effect of drug therapy is often limited. Uterine massage requires continuous operation by medical staff, and it is difficult to accurately and effectively control the bleeding site in some cases of deep bleeding or abnormal uterine morphology. Uterine artery embolization is a relatively effective interventional treatment method, but it is somewhat traumatic and requires professional interventional equipment and technicians. The operation is relatively complicated and is not suitable for all patients with uterine bleeding, especially in emergency situations. It is difficult to implement quickly.

[0004] Therefore, there is an urgent need for a device that can quickly and accurately deal with uterine bleeding and is easy to operate. Summary of the invention

[0005] The embodiment of the present application provides a device for treating uterine bleeding, which can effectively improve the problems of complex operation and poor hemostatic effect of current technical treatment for uterine bleeding.

[0006] In a first aspect, an embodiment of the present application provides a device for treating uterine bleeding, the device for treating uterine bleeding comprising: The balloon has a multi-layer structure, including an inner layer for providing support and pressure resistance, a middle layer for antibacterial properties, and an outer layer for contacting the inner wall of the uterus. The balloon is in a shape that fits the uterine cavity when inflated, and is flat and irregular when not inflated. The front end of the balloon is used to enter the uterine cavity, and the rear end is provided with a connecting component; A fixed wing, comprising a shape memory support and a medical flexible sleeve, wherein the shape memory support is located inside the medical flexible sleeve, the shape memory support has the characteristic of deforming according to temperature, and the predetermined shape of the shape memory support in an undeformed state fits closely with the inner wall of the balloon when it is inflated, and the medical flexible sleeve is sealed and connected to the rear end of the balloon; The trachea comprises a tube body and a plug connector, wherein the tube body is used to receive fluid flowing into and out of the balloon, one end of the plug connector is connected to the tube body, and the other end is used to be inserted into the connecting assembly to achieve the connection between the trachea and the balloon; A visualization component, comprising an image acquisition component located on the surface of the balloon, a light source for illuminating the image acquisition component, and a transmission component connecting the image acquisition component with an external terminal, wherein the image acquisition component has multi-degree-of-freedom adjustment and image information processing functions, and a buffer component is arranged around the image acquisition component; The pressure sensing and liquid release component includes a pressure sensitive element and a valve component. The pressure sensitive element is arranged on the outer layer and a liquid storage cavity is arranged inside the pressure sensitive element for storing a coagulation-promoting solution. The pressure sensitive element is provided with at least one liquid port for allowing the coagulation-promoting solution to enter and be discharged from the liquid storage cavity. The valve component is arranged at the liquid port for controlling the opening and closing of the liquid port.

[0007] In some embodiments of the present application, the inner layer, middle layer and outer layer of the balloon are all polyurethane coatings, the middle layer is filled with nanosilver particles, and the outer layer is coated with a fibrin-based hemostatic coating.

[0008] In some embodiments of the present application, the shape memory support members are distributed in a grid pattern inside the medical flexible sleeve, and the shape memory support members are in a curled deformation shape when the temperature is below a first temperature, and are in a predetermined shape when the temperature is above a second temperature; the first temperature is lower than the second temperature, and the second temperature is the normal body temperature of a human body; a protrusion is provided on the surface of the medical flexible sleeve to increase the surface friction of the medical flexible sleeve.

[0009] In some embodiments of the present application, the pressure sensitive element is a pressure sensitive film, the valve assembly includes a valve, a fixed plate, a first elastic member and a pressure-sensitive soft ball, the valve seal is arranged at the liquid port, one end of the first elastic member is connected to the valve and is located in the liquid storage chamber, the other end of the first elastic member is connected to the fixed plate, the fixed plate is located in the liquid storage chamber, and the pressure-sensitive soft ball is fixed to a side of the valve away from the first elastic member and protrudes outside the pressure sensitive film.

[0010] In some embodiments of the present application, the pressure-sensitive film has the properties of being deformable under pressure and being biocompatible.

[0011] In some embodiments of the present application, the inner wall of the liquid storage chamber is coated with a biomolecule aggregation-resistant coating, and the coagulation-promoting solution contains thrombin and fibrinogen. In some embodiments of the present application, a plurality of the plug connectors are arranged at intervals along the circumference of the tube body, and a side of the plug connector away from the tube body is a slope, and the connecting assembly includes a connecting ring connected to the balloon, the connecting ring is provided with a plug groove, and the plug groove includes a connected transverse groove and a vertical groove, and abutment blocks and a second elastic member are provided in the transverse groove, and the abutment blocks have a slope matching the slope of the plug connector, one end of the second elastic member is connected to the abutment block, and the other end is fixed to the inner wall of the transverse groove, when the second elastic member is in an undeformed state, the abutment block extends from one end of the second elastic member into the vertical groove, and when the plug connector is inserted into the vertical groove, the plug connector squeezes the abutment block to compress the second elastic member until the plug connector is inserted into the bottom of the vertical groove, and the abutment block cooperates with the inner wall of the vertical groove to clamp and fix the plug connector.

[0012] In some embodiments of the present application, the bevel angle of the plug connector ranges from 30° to 60°.

[0013] In some embodiments of the present application, the balloon is an eccentric structure and includes a recessed portion, and the image acquisition component is disposed in the recessed portion.

[0014] In some embodiments of the present application, an air inlet duct and an exhaust duct are provided in the tube body, a first one-way valve is provided in the air inlet duct for controlling the gas to flow only in the direction of flowing into the balloon along the air inlet duct, and a second one-way valve is provided in the exhaust duct for controlling the gas to flow only in the direction of flowing into the balloon along the air inlet duct.

[0015] It can be seen that the embodiment of the present application mainly uses the multi-layer structure of the balloon to facilitate its placement into the uterus when not inflated, and can adapt to the shape of the uterine cavity after inflation, providing a basis for effective hemostasis. The fixed wing, with the help of the characteristics of the shape memory support, deforms and recovers at different temperatures, fits tightly to the inner wall of the balloon under body temperature, and cooperates with the balloon to stabilize the position of the balloon, prevent it from shifting in the uterus, and ensure that the balloon exerts stable and continuous pressure on the bleeding site. The trachea can quickly establish a fluid channel through the convenient connection method of the plug connector and the balloon connection component, so that medical staff can accurately control the amount and pressure of the fluid in the balloon according to the information feedback from the visualization component. The image acquisition component of the visualization component directly obtains the internal image of the uterus on the surface of the balloon, and the multi-degree-of-freedom adjustment and information processing functions allow medical staff to fully understand the condition of the uterus, including the degree of fit between the bleeding point and the balloon, and the buffer component protects the image acquisition component to ensure stable monitoring. When the pressure-sensitive element of the pressure sensing and liquid release component is subjected to a large pressure, it can timely trigger the release of the procoagulant solution in the liquid storage cavity to the bleeding site, and combine the pressure of the balloon to achieve physical and chemical synergistic hemostasis. All components are closely linked, which comprehensively improves the accuracy, stability and effectiveness of the device in treating uterine bleeding. It can respond to uterine bleeding quickly and accurately, and is convenient and efficient to operate, effectively improving the current uterine bleeding treatment technology that is complex to operate and has poor hemostasis effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For those skilled in the art, other drawings can be obtained based on these drawings without creative work.

[0017] Figure 1 A schematic diagram of the structure of a device for treating uterine bleeding provided in an embodiment of the present application when not inflated; Figure 2 A schematic diagram of the structure of a device for treating uterine bleeding provided by an embodiment of the present application when inflated; Figure 3 A schematic diagram of the structure of a balloon in a device for treating uterine bleeding provided in an embodiment of the present application; Figure 4 for Figure 3 A magnified schematic diagram of part A; Figure 5 A schematic diagram of the structure of a trachea in a device for treating uterine bleeding provided in an embodiment of the present application; Figure 6 A schematic diagram of the structure of the connection between the plug connector and the connecting ring in a device for treating uterine bleeding provided by an embodiment of the present application; Figure 7This is a schematic structural diagram of a device for treating uterine bleeding provided in an embodiment of the present application, in which a plug connector is not connected to a connecting ring.

[0018] Description of reference numerals: 1. Balloon; 11. Inner layer; 12. Middle layer; 13. Outer layer; 14. Recessed portion; 2. Fixed wing; 21. Shape memory support; 22. Medical flexible sleeve; 3. Trachea; 31. Tube body; 311. Air inlet; 312. Exhaust duct; 32. Plug connector; 33. First one-way valve; 34. Second one-way valve; 4. Visualization component; 41. Image acquisition component; 5. Pressure sensing and liquid release component; 51. Pressure sensitive element; 511. Liquid storage chamber; 52. Valve component; 521. Fixed plate; 522. Valve; 523. First elastic member; 524. Pressurized soft ball; 6. Buffer component; 7. Connecting component; 71. Connecting ring; 72. Plug slot; 721. Vertical slot; 722. Horizontal slot; 73. Abutment block; 74. Second elastic member. DETAILED DESCRIPTION

[0019] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of the present application.

[0020] In the description of this application, it should be understood that the words "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or indicating the number of technical features indicated. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more features. In the description of this application, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0021] See also Figures 1 to 7 , an embodiment of the present application provides a device for treating uterine bleeding, comprising: The balloon 1 has a multi-layer structure, including an inner layer 11 for providing support and pressure resistance, a middle layer 12 for antibacterial properties, and an outer layer 13 for contacting the inner wall of the uterus. The balloon 1 is in a shape that fits the uterine cavity when inflated, and is flat and irregular when not inflated. The front end of the balloon 1 is used to enter the uterine cavity, and the rear end is provided with a connecting component 7; The fixed wing 2 includes a shape memory support member 21 and a medical flexible sleeve 22. The shape memory support member 21 is located in the medical flexible sleeve 22. The shape memory support member 21 has the characteristic of deforming according to temperature, and the predetermined shape of the shape memory support member 21 in an undeformed state fits closely with the inner wall of the balloon 1 when it is inflated. The medical flexible sleeve 22 is sealed and connected to the rear end of the balloon 1.

[0022] The trachea 3 includes a tube body 31 and a plug connector 32. The tube body 31 is used to receive fluid flowing into and out of the balloon 1. One end of the plug connector 32 is connected to the tube body 31, and the other end is used to be inserted into the connecting component 7 to achieve the connection between the trachea 3 and the balloon 1.

[0023] The visualization component 4 includes an image acquisition component 41 located on the surface of the balloon 1, a light source for providing illumination for the image acquisition component 41, and a transmission component connecting the image acquisition component 41 with an external terminal. The image acquisition component 41 has multi-degree-of-freedom adjustment and image information processing functions, and a buffer component 6 is provided around the image acquisition component 41.

[0024] The pressure sensing and liquid releasing component 5 comprises a pressure sensitive element 51 and a valve 522 component 52. The pressure sensitive element 51 is arranged on the outer layer 13 and a liquid storage cavity 511 is arranged inside the pressure sensitive element 51 for storing a coagulation promoting solution. The pressure sensitive element 51 is provided with at least one liquid port for allowing the coagulation promoting solution to enter and be discharged from the liquid storage cavity 511. The valve 522 component 52 is arranged at the liquid port for controlling the opening and closing of the liquid port.

[0025] It should be noted that, with respect to the device, the terms "front end" and "rear end" refer to the perspective of the device operator, the rear end refers to the end inserted into the vagina, and the front end refers to the end closest to the operator.

[0026] The technical solution provided by the present application can be conveniently placed in the uterus when the balloon 1 is not inflated through the multi-layer structure, and can adapt to the shape of the uterine cavity after inflation, providing a basis for effective hemostasis. The fixed wing 2, with the help of the characteristics of the shape memory support 21, deforms and recovers at different temperatures, and fits tightly to the inner wall of the balloon 1 under body temperature, and cooperates with the balloon 1 to stabilize the position of the balloon 1, prevent it from shifting in the uterus, and ensure that the balloon 1 exerts stable and continuous pressure on the bleeding site. The trachea 3 can quickly establish a fluid channel through the convenient connection method of the plug connector 32 and the balloon 1 connection component 7, so that medical staff can accurately control the amount and pressure of the fluid in the balloon 1 according to the information fed back by the visualization component 4. The image acquisition component 41 of the visualization component 4 directly obtains the internal image of the uterus on the surface of the balloon 1. The multi-degree-of-freedom adjustment and information processing functions allow medical staff to fully understand the condition of the uterus, including the degree of fit between the bleeding point and the balloon 1, and the buffer component 6 protects the image acquisition component 41 to ensure stable monitoring. When the pressure sensitive element 51 of the pressure sensing and liquid releasing component 5 is subjected to a large pressure, it can timely trigger the release of the procoagulant solution in the liquid storage chamber 511 to the bleeding site, and achieve physical and chemical synergistic hemostasis in combination with the compression of the balloon 1. The various components are closely linked, which comprehensively improves the accuracy, stability and effectiveness of the device in treating uterine bleeding, can quickly and accurately respond to uterine bleeding, is convenient and efficient to operate, and effectively improves the current uterine bleeding treatment technology with complex operation and poor hemostasis effect.

[0027] In some embodiments, see Figures 1 to 3 The inner layer 11 of the balloon 1 is made of polyurethane coating material. The polyurethane is evenly coated on the mold surface through a specific coating process to form an inner layer 11 structure with support and pressure resistance. This process can ensure that the thickness of the inner layer 11 is uniform, so that it can withstand a certain pressure without deformation or rupture when inflated. For example, after multiple experimental tests, when the polyurethane coating of the inner layer 11 reaches a certain thickness (such as 0.3-0.8mm), it can meet the requirements of the intrauterine pressure environment.

[0028] The middle layer 12 is also a polyurethane coating, and the nanosilver particles are dispersed as evenly as possible during the coating process. The amount of nanosilver particles added has been calculated and verified by experiments. Generally, it is added at a ratio of 3% to 8% of the mass of polyurethane, which can ensure a good antibacterial effect without causing adverse effects on the human body. This antibacterial middle layer 12 can effectively inhibit the growth of bacteria in the uterus and the balloon 1, reducing the risk of infection.

[0029] The surface of the polyurethane coating of the outer layer 13 is coated with a fibrin-based hemostatic coating, and the hemostatic coating is uniformly attached to the surface of the outer layer 13 by spraying or dipping. Fibrin-based substances can rapidly promote the coagulation process when in contact with blood, thereby enhancing the hemostatic effect.

[0030] The prepared three layers of materials are tightly attached together through heat sealing or bonding processes to form a complete balloon 1 structure, ensuring that there are no gaps or leaks between the layers. The balloon 1 is flat and irregular when not inflated, making it easy to enter the uterus through the cervical opening; after inflation, its shape can adapt to the complex shape of the uterine cavity and effectively compress the bleeding site.

[0031] In some embodiments, see Figure 3 The shape memory support 21 is made of materials with shape memory effect such as nickel-titanium alloy wire, which is processed into a grid structure, and the mesh wire diameter is controlled between 0.1-0.3mm to ensure its stability and elasticity during the deformation process. Then the grid-shaped shape memory support 21 is embedded in a medical flexible sleeve 22 (such as a silicone sleeve), and the thickness of the medical flexible sleeve 22 is about 0.5-1.5mm, which can protect the shape memory support 21 and ensure its softness and biocompatibility when it contacts the uterine wall.

[0032] See also Figure 1 and Figure 3 The medical flexible sleeve 22 is provided with protrusions with a height of about 0.1-0.3 mm, which are fixed to the flexible sleeve surface by integral molding or later bonding. These protrusions can increase the friction between the medical flexible sleeve 22 and the inner wall of the uterus, further preventing the balloon 1 from shifting.

[0033] In some embodiments, the root of the fixed wing 2 is sealed to the rear end of the balloon 1 through a heat-sealing process. The heat-sealing temperature, pressure and time are strictly controlled to ensure a firm connection and good sealing to prevent gas or liquid leakage. The heat-sealing process is a conventional process, and the specific temperature, pressure and time are not repeated here. The shape memory support 21 is curled and deformed at low temperatures (such as 0-5°C), which facilitates the device to enter the uterus; after entering the uterus, it quickly returns to a predetermined shape under body temperature (about 37°C). The predetermined shape will support the medical flexible sleeve 22, so that the medical flexible sleeve 22 remains in a stretched state. The medical flexible sleeve 22 fits tightly with the inner wall of the balloon 1 when it is inflated, thereby stabilizing the position of the balloon 1.

[0034] In some embodiments, see Figure 5The tube body 31 of the trachea 3 is made of medical grade plastic or rubber material, and has certain flexibility and pressure resistance. An air inlet 311 and an exhaust duct 312 are arranged in the tube body 31, a first one-way valve 33 is installed in the air inlet 311, and a second one-way valve 34 is installed in the exhaust duct 312. The first one-way valve 33 and the second one-way valve 34 adopt a micro valve structure, and the valve material is rubber or plastic with good biocompatibility. The first one-way valve 33 is opened during air intake, and the second one-way valve 34 is closed, ensuring that the gas can only flow into the balloon 1 along the air inlet 311. Specifically, the air intake can be connected to the rear end of the tube body 31 with an external inflation device, such as an inflation pump, and the inflation pump inflates the air inlet 311 in the tube body 31, and then completes the inflation of the balloon 1. Because the first one-way valve 33 restricts the gas to only enter the balloon 1 from the air inlet 311, it cannot flow out of the air inlet 311 from the balloon 1, thereby ensuring that the air inlet 311 will not be deflated. The second one-way valve 34 is opened during exhaust, and the first one-way valve 33 is closed, ensuring that the gas can only flow into the exhaust passage 312 along the balloon 1. The specific exhaust can be achieved by connecting the rear end of the tube body 31 to an external vacuum device, such as a vacuum pump. The vacuum pump exhausts the exhaust passage 312, so that the waste gas in the balloon 1 flows out through the exhaust passage 312. After the balloon 1 becomes deflated, it is convenient to remove the balloon 1 from the uterus.

[0035] In some embodiments, see Figure 6 and Figure 7 , multiple plug connectors 32 are arranged at intervals along the circumference of the tube body 31, and the number is generally 3-5. The side of the plug connector 32 away from the tube body 31 is an inclined surface, and the angle of the inclined surface ranges from 30° to 60°. The inclined surface facilitates the plug connector 32 to be inserted into the connection component 7 of the balloon 1. The connection component 7 includes a connecting ring 71 connected to the balloon 1, and the connecting ring 71 is provided with a plug groove 72, and the plug groove 72 is composed of a connected horizontal groove 722 and a vertical groove 721. An abutment block 73 and a second elastic member 74 are installed in the horizontal groove 722. The abutment block 73 is made of medical plastic or rubber and has an inclined surface matching the inclined surface of the plug connector 32. The second elastic member 74 is a spring. The elastic coefficient of the spring is selected according to the insertion force and clamping force requirements of the plug connector 32, and is generally between 0.5-2 N / mm. When the plug connector 32 is inserted into the vertical groove 721, the plug connector 32 squeezes the abutment block 73 to compress the second elastic member 74 until the plug connector 32 is inserted into the bottom of the vertical groove 721. At this time, the abutment block 73 cooperates with the inner wall of the vertical groove 721 under the action of the second elastic member 74 to clamp and fix the plug connector 32, thereby realizing a quick connection between the trachea 3 and the balloon 1; when disassembly is required, appropriate external force is applied to pull out the trachea 3, the plug connector 32 is disengaged from the vertical groove 721, and the second elastic member 74 returns to its original state, allowing the abutment block 73 to extend into the vertical groove 721.

[0036] In some embodiments, see Figure 3The image acquisition component 41 uses a micro high-definition camera, and its lens uses a wide-angle lens with a viewing angle range of 100°-150°, which can obtain a larger range of internal images of the uterus. The camera has a multi-degree-of-freedom adjustment function, and can achieve up and down, left and right, front and back movement and rotation adjustment of about ±30° through a micro motor or a flexible connection structure. The structure used for the multi-degree-of-freedom adjustment of the camera is an existing structure, which will not be repeated here, and the micro high-definition camera that can move and rotate is a product available on the market, so the specific structure will not be repeated. The image acquisition component 41 is installed in the recessed portion 14 set by the eccentric structure of the balloon 1. The depth and shape of the recessed portion 14 are designed according to the shape of the camera, so that the camera can be stably installed without affecting the overall performance of the balloon 1. The setting of the recessed portion 14 enables the image acquisition component 41 to be located in the recessed portion 14. When the balloon 1 is expanded and squeezed to squeeze the uterus, it can ensure that the camera will not squeeze the inner wall of the uterus as much as possible, avoiding damage to the camera and injury to the inner wall of the uterus.

[0037] Furthermore, the light source uses a plurality of LED lights distributed in a ring, the number of which is 4-6, surrounding the image acquisition component 41 to provide sufficient lighting for the camera to ensure clear images. The brightness and color temperature of the LED lights are optimized to adapt to the ambient light conditions in the uterus, for example, the brightness is between 50-150 lumens and the color temperature is between 4000-6000K.

[0038] Furthermore, the transmission component uses an extremely fine wire with a wire diameter of about 0.1-0.2 mm, and the wire is covered with insulating and protective materials (such as polyimide film, with a thickness of about 0.05-0.1 mm) to ensure the stability and safety of signal transmission. The wire connects the image acquisition component 41 to an external terminal (such as a display screen, a computer, etc.) to achieve real-time transmission of image information. A buffer component 6 is arranged around the image acquisition component 41. The buffer component 6 is made of silica gel or gel material, with a thickness of about 0.5-1 mm, and is wrapped around the camera. During the inflation process of the balloon 1, the buffer component 6 can absorb the pressure of the balloon 1 on the camera to prevent it from being damaged due to excessive squeezing, thereby ensuring that the visualization component 4 can work continuously and stably.

[0039] Of course, in some embodiments, the transmission component may be eliminated and a wireless transmission mode may be adopted.

[0040] In some embodiments, see Figure 3 and Figure 4The pressure sensitive element 51 adopts a pressure sensitive film with a thickness between 0.1 and 0.5 mm, and is made of a polymer material (such as polyurethane elastomer) with good biocompatibility and elasticity. The pressure sensitive film is tightly combined with the outer layer 13 of the balloon 1, and a liquid storage chamber 511 is formed inside it. The volume of the liquid storage chamber 511 is designed to be between 3 and 10 ml according to the size of the device and the use requirements. The number and setting position of the pressure sensitive elements 51 can be determined according to actual conditions. In this embodiment, only one pressure sensitive element 51 is schematically drawn on the top of the balloon 1. The number and setting position of the pressure sensitive elements 51 are mainly set according to the location of uterine bleeding and the number of bleeding points.

[0041] The valve 522 assembly 52 comprises a valve 522, a fixing plate 521, a first elastic member 523 and a pressure-bearing soft ball 524. The valve 522 is made of medical plastic or rubber, so that the valve 522 has a certain elasticity, and the size of the valve 522 is larger than the size of the liquid port, so that when the valve 522 is sealed and arranged at the liquid port, the valve 522 will be squeezed by the inner wall of the liquid port, thereby improving the sealing effect of the valve 522, and effectively preventing the solution in the liquid storage cavity 511 from leaking. One end of the first elastic member 523 is connected to the valve 522 and is located in the liquid storage cavity 511. The first elastic member 523 is a spring, and its elastic coefficient is selected according to the required triggering pressure, generally between 0.1-1 N / mm. When the pressure of the uterine wall on the pressure-sensitive film reaches a set value, the film deformation pushes the valve 522 to overcome the spring resistance and open. The other end of the first elastic member 523 is connected to the fixing plate 521, and the fixing plate 521 is located in the liquid storage cavity 511, and is made of medical plastic or metal material, and is used to fix the position of the spring. The pressure-bearing soft ball 524 is fixed to the side of the valve 522 away from the first elastic member 523 and protrudes outside the pressure-sensitive film. The pressure-bearing soft ball 524 is made of a soft material with good biocompatibility (such as silicone) and has a radius of about 2-5 mm. When the local pressure of the uterine wall increases, the pressure-bearing soft ball 524 is squeezed first and the pressure is transmitted to the valve 522, triggering the valve 522 to open.

[0042] Further, the inner wall of the liquid storage chamber 511 is coated with an anti-biomolecule aggregation coating, which can be a heparin coating or a hydrophilic polymer coating, and the coating thickness is between 0.01-0.05 mm, which can prevent the biomolecules (such as thrombin and fibrinogen) in the coagulation-promoting solution from aggregating or precipitating during storage, thereby ensuring the effectiveness of the solution. The coagulation-promoting solution contains thrombin and fibrinogen, and the concentrations thereof are adjusted according to the clinical hemostasis requirements. Generally, the thrombin concentration is between 500-2000 international units / ml, and the fibrinogen concentration is between 50-200 mg / ml. When the compressed soft ball 524 is compressed, the first elastic member 523 is compressed, so that the valve 522 is opened, and the pro-coagulation solution in the liquid storage chamber 511 is released to the bleeding site through the liquid port, and the physical and chemical synergistic hemostasis is achieved in combination with the compression of the balloon 1.

[0043] The specific working process of the device for treating uterine bleeding provided by the present application is as follows: The fixed wing 2 of the device is pre-treated in a low temperature environment (such as using an ice bag or a low temperature box) to curl it so that it can easily enter the uterus through the cervical opening. At the same time, check whether the trachea 3, the visualization component 4, the pressure sensing and liquid release component 5 and other components are working properly, ensure that the image acquisition component 41, the light source, the transmission component, the valve 522 component 52 and other functions are intact, and promote that the coagulation solution has been correctly filled in the liquid storage cavity 511 without leakage.

[0044] Medical staff use forceps or other appropriate medical instruments to slowly insert the uninflated balloon 1 into the uterine cavity through the cervical opening, and the operation should be gentle and slow to avoid damage to the cervix and uterine wall. According to the size and shape of the uterus, the balloon 1 is pushed to a suitable position, generally so that the front end of the balloon 1 reaches near the bottom of the uterus.

[0045] Connect the trachea 3 to an external inflation device (such as a syringe or an inflation pump), and inject an appropriate amount of gas (such as carbon dioxide or air) into the balloon 1 through the air inlet 311 of the trachea 3. As the gas is injected, the balloon 1 begins to expand, and its shape gradually adapts to the shape of the uterine cavity, exerting uniform pressure on the uterine wall to compress the bleeding site. During the inflation process, medical staff can observe the fit between the balloon 1 and the uterine wall through the visualization component 4 to ensure that the balloon 1 covers the bleeding point and achieves effective compression. After the balloon 1 enters the uterus, under the action of body temperature, the shape memory support 21 of the fixed wing 2 restores the predetermined shape, and the medical flexible sleeve 22 fits tightly with the inner wall of the balloon 1. The protrusions on its surface increase the friction with the uterine wall, preventing the balloon 1 from shifting in the uterus, stabilizing the compression position of the balloon 1, and ensuring the hemostatic effect.

[0046] During the inflation and compression process of the balloon 1, the visualization component 4 continues to work. The image acquisition component 41 illuminates the inside of the uterus through a light source, uses a multi-degree-of-freedom adjustment function and a wide-angle lens to capture the situation inside the uterus, and transmits the image to the external terminal in real time through a transmission component. By observing the image displayed on the external terminal, medical staff can fully understand the location of the bleeding point in the uterus, the degree of fit between the balloon 1 and the uterine wall, and other information. If it is found that the area around the camera or other local areas is bleeding continuously due to poor fit between the balloon 1 and the uterine wall and the pressure does not reach the effective hemostasis standard, the pressure sensitive element 51 on the wall of the balloon 1 in this area will deform due to the pressure change. For example, when the pressure of the uterine wall on the pressure-sensitive film exceeds the pressure value corresponding to the elastic coefficient set by the spring, the compressed soft ball 524 is squeezed, compressing the first elastic member 523, so that the valve 522 is opened. At this time, the coagulation-promoting solution (containing thrombin and fibrinogen) in the liquid storage chamber 511 flows out through the liquid port under pressure, exerts a coagulation effect at the bleeding site, and achieves physical and chemical synergistic hemostasis in combination with the compression of the balloon 1. As the pressure-sensitive film is deformed under pressure, the space of the liquid storage chamber 511 will be compressed, increasing the pressure of the solution flowing in the liquid storage chamber 511, further accelerating hemostasis. At the same time, the pressure generated by the pressure-sensitive film under pressure deformation on the solution in the liquid storage chamber 511 can also effectively prevent the solution from flowing back.

[0047] When the bleeding is effectively controlled, the medical staff holds the trachea 3 and replaces the external inflation device with a vacuum device, which is connected to the exhaust duct 312 to exhaust the balloon 1. Of course, the gas in the balloon 1 can also be naturally discharged through the exhaust duct 312 of the trachea 3 or assisted by simple pressing, and the balloon 1 shrinks accordingly. Then, the balloon 1 is slowly pulled out of the uterus by holding the trachea 3.

[0048] After the device is completely removed from the uterus, the electronic components on the device, such as the visualization component 4, are removed, cleaned and disinfected, and used again. Then, the trachea 3 is held, and a certain pulling force is applied in the direction away from the balloon 1, so that the plug connector 32 at the connection end of the trachea 3 gradually comes out of the vertical groove 721, and the abutment block 73 is extended into the vertical groove 721 by the second elastic member 74, thereby realizing the separation of the trachea 3 from the balloon 1. The outer surface and the internal airway of the trachea 3 are cleaned and disinfected for subsequent continuous use. For the balloon 1, the hemostatic coating of its outer layer 13 and the possible residual coagulation-promoting solution and other disposable consumables are treated as medical waste after the device is removed; and the other parts of the balloon 1, the fixed wing 2 and other reusable parts are treated according to strict cleaning, disinfection and sterilization processes and are ready for use. Later, the hemostatic coating can be further applied to the outside of the balloon 1 and the coagulation-promoting solution can be filled in the pressure-sensitive film. The treatment process includes soaking and rinsing with professional medical cleaning agents to remove contaminants, and then using high-temperature and high-pressure steam sterilization or ethylene oxide sterilization to ensure sterility and no residue. After each treatment, it must pass quality tests such as microbial testing and chemical testing before it can be put into use again.

[0049] In summary, during the entire use process, all components work closely together. The balloon 1 provides basic compression hemostasis function, the fixed wing 2 ensures the stable position of the balloon 1, the trachea 3 realizes the inflation and deflation control of the balloon 1, the visualization component 4 provides accurate monitoring information for medical staff, and the pressure sensing and liquid release component 5 performs chemical hemostasis intervention for local bleeding, which comprehensively improves the accuracy, stability and effectiveness of the device in treating uterine bleeding. The operation is simple and convenient, and effectively solves the problems existing in the existing uterine bleeding treatment technology.

[0050] The basic concepts have been described above. Obviously, for those skilled in the art, the above detailed disclosure is only for example and does not constitute a limitation of the present application. Although not explicitly stated herein, those skilled in the art may make various modifications, improvements and amendments to the present application. Such modifications, improvements and amendments are suggested in the present application, so such modifications, improvements and amendments still belong to the spirit and scope of the exemplary embodiments of the present application.

[0051] At the same time, the present application uses specific words to describe the embodiments of the present application. For example, "one embodiment", "an embodiment", and / or "some embodiments" refer to a certain feature, structure or characteristic related to at least one embodiment of the present application. Therefore, it should be emphasized and noted that "one embodiment" or "an embodiment" or "an alternative embodiment" mentioned twice or more in different positions in this specification does not necessarily refer to the same embodiment. In addition, some features, structures or characteristics in one or more embodiments of the present application can be appropriately combined.

[0052] Similarly, it should be noted that in order to simplify the description of the disclosure of this application and thus help understand one or more application embodiments, in the above description of the embodiments of this application, multiple features are sometimes merged into one embodiment, figure or description thereof. However, this disclosure method does not mean that the features required by the object of this application are more than the features mentioned in the claims. In fact, the features of the embodiments are less than all the features of the single embodiment disclosed above.

[0053] Each patent, patent application, patent application publication, and other materials, such as articles, books, specifications, publications, documents, etc., cited in this application is hereby incorporated by reference in its entirety, except for application history documents that are inconsistent with or conflicting with the content of this application, and documents that limit the broadest scope of the claims of this application (currently or later attached to this application). It should be noted that if the description, definition, and / or use of terms in the attached materials of this application are inconsistent or conflicting with the content of this application, the description, definition, and / or use of terms in this application shall prevail.

[0054] The above are only preferred embodiments of the present application and are not intended to limit the present application. For those skilled in the art, the present application may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A device for treating uterine bleeding, characterized in that: include: The balloon has a multi-layer structure, including an inner layer for providing support and pressure resistance, a middle layer for antibacterial properties, and an outer layer for contacting the inner wall of the uterus. The balloon is in a shape that fits the uterine cavity when inflated, and is flat and irregular when not inflated. The front end of the balloon is used to enter the uterine cavity, and the rear end is provided with a connecting component; A fixed wing, comprising a shape memory support and a medical flexible sleeve, wherein the shape memory support is located inside the medical flexible sleeve, the shape memory support has the characteristic of deforming according to temperature, and the predetermined shape of the shape memory support in an undeformed state fits closely with the inner wall of the balloon when it is inflated, and the medical flexible sleeve is sealed and connected to the rear end of the balloon; The trachea comprises a tube body and a plug connector, wherein the tube body is used to receive fluid flowing into and out of the balloon, one end of the plug connector is connected to the tube body, and the other end is used to be inserted into the connecting assembly to achieve the connection between the trachea and the balloon; A visualization component, comprising an image acquisition component located on the surface of the balloon, a light source for illuminating the image acquisition component, and a transmission component connecting the image acquisition component with an external terminal, wherein the image acquisition component has multi-degree-of-freedom adjustment and image information processing functions, and a buffer component is arranged around the image acquisition component; The pressure sensing and liquid releasing component comprises a pressure sensitive element and a valve component. The pressure sensitive element is arranged on the outer layer and a liquid storage cavity is arranged inside the pressure sensitive element for storing a coagulation promoting solution. The pressure sensitive element is provided with at least one liquid port for allowing the coagulation promoting solution to enter and be discharged from the liquid storage cavity. The valve component is arranged at the liquid port for controlling the opening and closing of the liquid port.

2. The device for treating uterine bleeding according to claim 1, characterized in that: The inner layer, middle layer and outer layer of the balloon are all polyurethane coatings, the middle layer is filled with nano silver particles, and the surface of the outer layer is coated with a fibrin hemostatic coating.

3. The device for treating uterine bleeding according to claim 1, characterized in that: The shape memory support parts are distributed in the medical flexible sleeve in a grid shape. When the shape memory support parts are below a first temperature, they are in a curled deformation shape, and when the shape memory support parts are above a second temperature, they are in a predetermined shape. The first temperature is lower than the second temperature, and the second temperature is the normal body temperature of the human body. The surface of the medical flexible sleeve is provided with protrusions for increasing the surface friction of the medical flexible sleeve.

4. The device for treating uterine bleeding according to claim 1, characterized in that: The pressure sensitive element is a pressure sensitive film, and the valve assembly includes a valve, a fixed plate, a first elastic member and a pressure-bearing soft ball. The valve seal is arranged at the liquid port, one end of the first elastic member is connected to the valve and is located in the liquid storage cavity, and the other end of the first elastic member is connected to the fixed plate, and the fixed plate is located in the liquid storage cavity. The pressure-bearing soft ball is fixed to a side of the valve away from the first elastic member and protrudes outside the pressure sensitive film.

5. The device for treating uterine bleeding according to claim 4, characterized in that: The pressure sensitive film has the characteristics of deformation under pressure and biocompatibility.

6. The device for treating uterine bleeding according to claim 4, characterized in that: The inner wall of the liquid storage cavity is coated with a coating to prevent biomolecule aggregation, and the coagulation-promoting solution contains thrombin and fibrinogen.

7. The device for treating uterine bleeding according to claim 1, characterized in that: The plurality of plug connectors are arranged at intervals along the circumference of the tube body, and the side of the plug connector away from the tube body is an inclined surface, and the connecting assembly includes a connecting ring connected to the balloon, the connecting ring is provided with a plug groove, and the plug groove includes a connected transverse groove and a vertical groove, and abutment blocks and second elastic members are provided in the transverse groove, and the abutment blocks have an inclined surface matching the inclined surface of the plug connector, one end of the second elastic member is connected to the abutment block, and the other end is fixed to the inner wall of the transverse groove, when the second elastic member is in an undeformed state, the abutment block extends away from the end of the second elastic member into the vertical groove, and when the plug connector is inserted into the vertical groove, the plug connector squeezes the abutment block to compress the second elastic member until the plug connector is inserted into the bottom of the vertical groove, and the abutment block cooperates with the inner wall of the vertical groove to clamp and fix the plug connector.

8. The device for treating uterine bleeding according to claim 7, characterized in that: The bevel angle of the plug connector ranges from 30° to 60°.

9. The device for treating uterine bleeding according to any one of claims 1 to 8, characterized in that: The balloon is an eccentric structure and includes a recessed portion, and the image acquisition component is arranged in the recessed portion.

10. The device for treating uterine bleeding according to any one of claims 1 to 8, characterized in that: An air inlet and an air exhaust passage are provided in the tube body. A first one-way valve is provided in the air inlet for controlling the gas to flow only in the direction of flowing into the balloon along the air inlet. A second one-way valve is provided in the exhaust passage for controlling the gas to flow only in the direction of flowing into the balloon along the exhaust passage.

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