Rapid hemostasis balloon and system
By using an automatic docking system and a multi-balloon design, the problems of tubing confusion and regional adjustment in existing technologies are solved, enabling efficient and accurate hemostasis.
Patent Information
- Application Number
- PCT/CN2024/124613
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-10-08
- Filing Date
- 2024-10-14
- Publication Date
- 2026-04-16
AI Technical Summary
Existing hemostatic balloon devices are prone to tubing confusion during clinical operation, making it difficult to achieve regional adjustment and real-time monitoring, and the hemostatic effect is poor, affecting the efficiency and accuracy of operation.
A rapid hemostasis balloon system was designed, including a balloon assembly, a catheter assembly, and an inflation and dispensing assembly. The inflation and dispensing assembly automatically docks with the target balloon for fluid inflation. Combined with multiple independent balloons and imaging acquisition devices, regional hemostasis and real-time monitoring can be achieved.
It reduces manual operation time, improves balloon infusion efficiency, enables flexible compression hemostasis in specific areas of the body cavity, provides intuitive operation reference, and improves hemostasis effect and efficiency.
Smart Images

Figure CN2024124613_16042026_PF_FP_ABST
Abstract
Description
Rapid hemostasis balloon and system Technical Field
[0001] This invention relates to the field of medical electronics technology, and in particular to a rapid hemostasis balloon and system. Background Technology
[0002] For surgical hemostasis in natural body cavities (such as the abdominal cavity, uterine cavity, and nasal cavity), traditional methods involve local packing with materials like gauze or expanded sponges to achieve pressure hemostasis. While effective, this method is difficult to implement, resulting in uneven pressure on the cavity walls and the potential for dead space formation, leading to hemostasis failure. Furthermore, some packing materials have rough surfaces, increasing patient pain. Therefore, current technology has developed various balloon catheters for hemostasis in natural body cavities. Taking the uterine cavity as an example, hemostatic balloons are commonly used for postpartum hemostasis. An uninflated balloon is inserted into the lower segment of the uterine cavity, then inflated with fluid. This creates hydrostatic pressure from inside the uterine cavity to outside, exceeding the uterine artery pressure. The inflated balloon acts directly on the lower part of the uterus, near the uterine artery inlet, effectively reducing blood flow into the uterus. This method is relatively simple, quick, and provides rapid hemostasis. The balloon is also easy to remove after the fluid is drained post-operatively. Furthermore, considering the issue of balloon slippage during intrauterine balloon hemostasis—especially in patients with postpartum hemorrhage after vaginal delivery or cesarean section following cervical dilation, due to cervical laxity and / or cervical lacerations, the hemostatic balloon can easily slip out into the vagina after being inflated, preventing it from being properly placed in the uterine cavity and resulting in poor hemostasis—existing technologies also provide a hemostatic balloon anti-slippage structure as a technical solution to prevent hemostatic balloon slippage. For example, Chinese patent ZL202010227168.1 discloses a pressure-adjustable uterine hemostasis balloon device, including an injection hemostasis component, an injection device, and a cervical cover. The injection hemostasis component includes a hemostasis balloon, an injection tube, and a first drainage tube. The injection tube is located on the inner wall of the first drainage tube, and the first drainage tube has a drainage port located above the hemostasis balloon. The cervical cover is located below the hemostasis balloon, has an air bladder inside, and a sliding channel in the middle. The first drainage tube can move within the sliding channel, and a limiting structure is provided between the sliding channel and the first drainage tube. The cervical cover is detachably fixed to the outer wall of the first drainage tube through the limiting structure. After the air bladder inside the cervical cover is inflated, the cervical cover is positioned between the posterior fornix of the vagina and the inner side of the pubic arch, and the cervical cover is squeezed inward towards the cervical os, causing the cervical os to tend to close. The cervical cover also has a drainage hole, a second drainage tube, and a collection bag. For example, Chinese patent application CN202210475406.X discloses an anti-dislodgement device for a hemostatic balloon for postpartum hemorrhage, which includes a fixing ring and an elastic clip. The clip of the elastic clip is locked inside the fixing ring, and the clip opening of the elastic clip is set towards the cervix. The elastic clip is provided with an adjusting airbag for adjusting the distance between the two clips, and the adjusting airbag is fixed between the two clips.This anti-loosening device works in conjunction with a hemostatic balloon. During use, the hemostatic balloon is slowly inserted into the uterine cavity. Once the bottom of the balloon reaches the bottom of the uterus, water is injected into it, causing the balloon to compress the uterine cavity. Meanwhile, the regulating and compressive balloons of the anti-loosening device are inflated. The regulating balloon expands the two clips outwards, ensuring the clips secure the elastic clamps to the regulating ring. Continued inflation injects air into the compressive balloon, compressing the cervix. As can be seen, with this anti-loosening hemostatic balloon structure, the device forms a multi-channel, multi-balloon structure. During hemostasis, each independent cavity needs to be individually inflated (either with fluid or air) to control the balloon's expansion.
[0003] Currently, for hemostatic balloon devices with multiple tubing and balloons, clinical operation usually requires manual connection of the balloon's infusion or inflation tubing to the respective infusion or inflation device. When the patient has many connected tubing and external devices, tubing confusion can easily occur. To ensure that each tubing is correctly connected to the corresponding device, medical staff often need to spend some time identifying and selecting the tubing, which consumes valuable treatment time and affects the efficiency of hemostasis.
[0004] On the other hand, traditional body cavity hemostasis balloons generally use single-lumen balloons. Since the expansion area cannot be adjusted when a single-lumen balloon is inflated, it is difficult to apply pressure to one or more locations for hemostasis, and it is difficult to meet the regional adjustment requirements of hemostasis balloons.
[0005] On the other hand, once the hemostatic balloon is inserted, it is operated within the body cavity. The balloon's inflation status within the body relies mainly on the doctor's experience, as the doctor cannot directly observe the situation inside the body cavity, increasing the difficulty of hemostasis and potentially leading to inadequate compression hemostasis. Therefore, existing technologies offer solutions that combine external ultrasound monitoring to detect the balloon's position within the body cavity. However, this requires the assistance of an ultrasound physician. Postpartum hemorrhage often involves heavy and rapid bleeding; waiting for the ultrasound physician to arrive before placing the hemostatic balloon can delay or even cause missed opportunities for rescue. Therefore, the procedure is inconvenient, and it is difficult to stably and in real-time monitor the balloon's inflation status and the situation within the body cavity during balloon inflation. Summary of the Invention
[0006] The purpose of this invention is to overcome the shortcomings of existing technologies and provide a rapid hemostasis balloon and system. The rapid hemostasis balloon solution provided by this invention includes a balloon assembly, a catheter assembly, and an inflation / dispensing assembly. The balloon assembly includes multiple balloons, and the inflation / dispensing assembly is disposed between the inflation device and the inflation ports of each balloon catheter. Upon receiving a balloon inflation command, the assembly identifies the target balloon to be inflated, connects it to the inflation port corresponding to the target balloon to form an infusion pathway, and inflates the target balloon by injecting fluid into it. After inflation is completed, the connection is released, and the inflation port valve of the target balloon returns to a closed state. This technical solution can automatically connect the inflation / dispensing assembly with the target balloon requiring fluid injection to form an infusion pathway according to the balloon inflation command, reducing manual operation, saving time, and improving balloon infusion efficiency.
[0007] To achieve the above objectives, the present invention provides the following technical solution: a rapid hemostasis balloon, comprising a balloon catheter, the balloon catheter comprising a catheter assembly and a balloon assembly, the balloon assembly being disposed on the catheter assembly, the catheter assembly being used to connect to an external inflation device; the balloon assembly comprising multiple balloons, the cavities of the multiple balloons being independent of each other; the catheter assembly comprising multiple balloon tubings, the balloon tubings being configured one-to-one with the balloons, each balloon tubing connecting its corresponding balloon to the aforementioned inflation device, and each balloon tubing inflation port being provided with a control valve; further comprising an inflation distribution component disposed between the inflation device and the inflation ports of each balloon tubing, the inflation distribution component being configured to: determine the target balloon to be inflated according to the received balloon inflation command, form an infusion pathway after docking with the inflation port of the balloon tubing corresponding to the target balloon to inflate the target balloon with fluid, at which time the control valve of the target balloon inflation port is opened; and after the fluid inflation is completed, disengage the aforementioned docking, and the control valve of the target balloon inflation port returns to the closed state.
[0008] Furthermore, the balloon assembly includes at least one hemostatic balloon and at least one anti-slip balloon, and the catheter assembly includes a hemostatic balloon conduit and an anti-slip balloon conduit. The hemostatic balloon includes a main balloon and multiple flattened secondary balloons disposed on the outer surface of the main balloon, with the cavities of the main balloon and the flattened secondary balloons being independent of each other. Corresponding to the main balloon and the multiple flattened secondary balloons, independent main balloon conduits and multiple secondary balloon conduits are respectively provided, with each secondary balloon conduit corresponding to a secondary balloon. The inflation port of the main balloon conduit can be connected to the aforementioned inflation distribution assembly to form an infusion pathway, and the inflation ports of each secondary balloon conduit can be connected to the aforementioned inflation distribution assembly to form an infusion pathway.
[0009] Furthermore, the balloon catheter is used for uterine cavity hemostasis. In this case, the hemostasis balloon is an intrauterine hemostasis balloon, which includes a main balloon and multiple flat auxiliary balloons arranged on the left and right sides of the main balloon. The multiple flat auxiliary balloons are arranged along the left and right sides of the main balloon, and the bottom of the flat auxiliary balloons is attached to the balloon wall of the main balloon. The anti-slip balloon is placed in the vagina. The anti-slip balloon is a ring-shaped balloon. After expansion, it is fixed in the vaginal fornix at the top of the vagina and surrounds the cervix, lifting the aforementioned intrauterine hemostasis balloon while closing the internal os of the cervix. The catheter assembly also includes a drainage tube. The distal end of the drainage tube passes through the inner ring of the ring-shaped anti-slip balloon and the inner cavity of the intrauterine hemostasis balloon in sequence and extends out of the intrauterine hemostasis balloon. A drainage port is provided at the distal end of the drainage tube, and the proximal end of the drainage tube is connected to a drainage device.
[0010] Furthermore, the shape of the intrauterine hemostatic balloon is adapted to the shape of the uterine cavity, and is a flat, inverted pear shape that is wider at the top and narrower at the bottom, with the anteroposterior diameter smaller than the lateral diameter.
[0011] Furthermore, each balloon in the balloon assembly is configured with a balloon name and / or balloon number, and the balloon name and / or balloon number are set in a one-to-one correspondence with the balloon, so that the corresponding balloon can be located by the balloon name and / or balloon number; the balloon inflation command includes the balloon name and / or balloon number of the target balloon that needs to be inflated with fluid, as well as the inflation parameter information of the target balloon.
[0012] Furthermore, the inflation and distribution assembly includes a controller and at least one inflation distributor, the inflation distributor being connected to the controller and receiving control from the controller; the controller is configured to receive a balloon inflation command and determine one or more target balloons to be inflated according to the balloon inflation command; the inflation distributor includes a balloon inflation head, configured to connect the balloon inflation head to the balloon tubing inflation port of the target balloon to form an infusion path according to the controller's control, and to inflate the target balloon with fluid according to the inflation parameter information of the target balloon; and after inflation, to separate the balloon inflation head from the balloon tubing inflation port of the target balloon according to the controller's control.
[0013] Furthermore, the inflation dispenser includes: a slide bar, corresponding to the inflation ports of each balloon, with multiple balloon inflation ports arranged in a row along the axial direction of the slide bar; an electric slider mounted on the slide bar, the electric slider including a slider part, a first drive part, and a second drive, the first end of the slider part being fitted with the aforementioned balloon inflation head, the first end being the end closest to the balloon inflation port; the first drive being used to drive the slider part to move on the slide bar according to the control of the controller to reach the balloon inflation port position of the target balloon; the second drive being used to drive the balloon inflation head to move towards the balloon inflation port of the target balloon according to the control of the controller to dock the balloon inflation head with the balloon inflation port, after docking, the inflation port control valve of the target balloon opens, and fluid is inflated through the balloon inflation head; after inflation, the second drive being used to drive the balloon inflation head to move in the opposite direction according to the control of the controller to separate from the balloon inflation port of the target balloon, and the first drive being used to drive the slider part to move on the slide bar to a target balloon position or return to the initial position according to the control of the controller.
[0014] Furthermore, each balloon tube is equipped with an image acquisition cavity for the fiber optic probe to enter the balloon cavity. Each balloon is made of transparent material. The camera fiber and the light guide fiber are located in the image acquisition cavity, and the fiber optic probe is located at the distal end of the image acquisition cavity and enters the corresponding balloon cavity. At the same time, a connector for the camera fiber and the light guide fiber is provided at the balloon tube filling port. The slider part also includes a camera connector and a light guide connector, which are located around the balloon filling head. When the balloon tube filling port is connected to the balloon filling head, the camera connector and the light guide connector are also connected to the connectors for the camera fiber and the light guide fiber, respectively, for electrical connection.
[0015] Furthermore, the infusion dispenser includes a multi-dimensional docking plate, on the upper surface of which the aforementioned balloon infusion head is disposed. Multiple balloon infusion ports are located on the same plane, which is parallel to the upper surface of the multi-dimensional docking plate. The multi-dimensional docking plate includes a sliding table, a rotating table, and a longitudinal shifter. The sliding table, rotating table, and longitudinal shifter are controlled by a controller. The balloon infusion head is mounted on the sliding table of the multi-dimensional docking plate via a lateral shifting mechanism, which drives the balloon infusion head to move laterally on the sliding table. The sliding table is mounted on the rotating table, which drives the sliding table to rotate, thereby rotating the balloon infusion head. The rotating table is mounted on the longitudinal shifter, which drives the rotating table to move longitudinally, thereby moving the balloon. The filling head can be connected to or disconnected from the balloon tubing filling port; when the balloon filling head is disconnected from the balloon tubing filling port, the fluid injection operation stops; or, the filling distributor includes a rotating docking plate, which includes a rotating section and a rotating drive structure. The rotating drive structure drives the rotating section to rotate, and multiple balloon tubing filling ports are arranged corresponding to the rotating section and located at different positions on the rotating section; the rotating section includes an input end and an output end, the input end is used to connect to the filling device, and the rotating drive structure can drive the rotating section to rotate under the control of the controller so that the output end is connected to the balloon tubing filling ports at different positions; when the output end is connected to the target balloon tubing filling port, the filling port control valve of the target balloon opens, and the fluid enters the balloon tubing through the rotating section and is then input into the target balloon.
[0016] The present invention also provides a balloon dilation system for uterine cavity hemostasis, the system comprising: an expandable balloon body, the expandable balloon body being the aforementioned rapid hemostasis balloon; and a balloon dilation control device, including a user-facing host computer, the host computer being used to display information of each balloon in the balloon assembly, and after acquiring a balloon inflation command issued by the user for one or more of the balloons, sending the balloon inflation command to the inflation and dispensing component of the aforementioned rapid hemostasis balloon.
[0017] Compared with existing technologies, this invention, by adopting the above technical solution, has the following advantages and positive effects, as an example: The rapid hemostasis balloon includes a balloon assembly, a catheter assembly, and an inflation dispensing assembly. The balloon assembly includes multiple balloons. The inflation dispensing assembly is disposed between the inflation device and the inflation ports of each balloon tubing. Upon receiving a balloon inflation command, it determines the target balloon to be inflated, and after docking with the inflation port corresponding to the target balloon, forms an infusion pathway to inflate the target balloon with fluid. After inflation is completed, it disengages the connection, and the inflation port valve of the target balloon returns to a closed state. This technical solution can automatically dock with the target balloon requiring fluid inflation via the inflation dispensing assembly to form an infusion pathway according to the balloon inflation command, reducing manual operation, saving operation time, and improving balloon infusion efficiency.
[0018] On the other hand, a multi-chamber hemostatic balloon with multiple auxiliary balloons is provided. Multiple flat auxiliary balloons are set in different areas on the outer surface of the main balloon. According to the received balloon inflation command, one or more auxiliary balloons can be flexibly and conveniently inflated with fluid through the inflation distribution component, thereby enabling flexible and efficient compression hemostasis in one or more areas within the body cavity, meeting the regional adjustment needs of the hemostatic balloon.
[0019] On the other hand, a variety of inflation dispensers were designed, and imaging equipment connection components were provided in combination with the structure of the inflation dispensers. This allows users to stably and in real time monitor information such as balloon inflation status and intracavitary conditions during balloon inflation, providing medical staff with more intuitive and accurate reference information. The operation is simple and convenient, avoiding the blind inflation of balloons in existing technologies. Attached Figure Description
[0020] Figure 1 is a schematic diagram of the structure of the rapid hemostasis balloon provided in an embodiment of the present invention.
[0021] Figure 2 is a schematic diagram of the structure of a hemostatic balloon including a main balloon and multiple flat auxiliary balloons provided in an embodiment of the present invention.
[0022] Figure 3 is a schematic diagram of the pipe arrangement in the conduit assembly provided in an embodiment of the present invention.
[0023] Figure 4 is an information processing logic diagram of the filling and dispensing component provided in an embodiment of the present invention.
[0024] Figure 5 is a schematic diagram of the structure of the filling dispenser provided in an embodiment of the present invention.
[0025] Figure 6 is a schematic diagram of the structure of the filling dispenser provided in an embodiment of the present invention.
[0026] Figure 7 is a schematic diagram of the layout of the balloon tube filling port provided in an embodiment of the present invention.
[0027] Figure 8 is a schematic diagram of the structure of the filling distributor II provided in an embodiment of the present invention.
[0028] Explanation of reference numerals in the attached drawings: Rapid hemostasis balloon 100; Hemostasis balloon 110, main balloon 111, left auxiliary balloons 112, 113, right auxiliary balloons 114, 115; Anti-slip balloon 120; Catheter assembly 130, drainage tube 131, balloon tubing 132, linear array of filling ports 133, circular array of filling ports 134; Inflation dispensing assembly 140, inflation dispenser one 142, slide bar 1421, electric slider 1422, first balloon inflation head 1423, inflation tubing 1424, camera connector and light guide connector 1425, fiber optic mirror line 1426, second inflation dispenser two 144, second balloon inflation head 1441, sliding stage 1442, rotating stage 1443, longitudinal shifter 1444; Inflation device 200; Drainage device 300. Detailed Implementation
[0029] The rapid hemostasis balloon and system disclosed in this invention will be further described in detail below with reference to the accompanying 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 isolated; they can be combined with each other to achieve better technical effects. In the accompanying drawings of the following embodiments, the same reference numerals appearing in each drawing represent the same features or components, which can be applied to different embodiments. Therefore, once an item is defined in one drawing, it does not need to be further discussed in subsequent drawings.
[0030] It should be noted that the structures, proportions, sizes, etc., illustrated in the accompanying drawings are merely for illustrative purposes and to aid those skilled in the art in understanding and reading the invention. They are not intended to limit the conditions under which the invention can be implemented. Any modifications to the structure, changes in proportions, or adjustments to size, provided they do not affect the effectiveness or purpose of the invention, should fall within the scope of the technical content disclosed in the invention. The scope of the preferred embodiments of the present invention includes other implementations, wherein functions may be performed not in the order stated or discussed, including substantially simultaneously or in reverse order, depending on the functions involved. This should be understood by those skilled in the art to which the embodiments of the present invention pertain.
[0031] Techniques, methods, and apparatus known to those skilled in the art may not be discussed in detail, but where appropriate, such techniques, methods, and apparatus should be considered part of the specification. In all examples shown and discussed herein, any specific values should be interpreted as merely exemplary and not as limitations. Therefore, other examples of exemplary embodiments may have different values.
[0032] In the description of the embodiments of this application, " / " means "or", and "and / or" is used to describe the relationship between related objects, indicating that there can be three relationships. For example, "A and / or B" means: A and B exist alone, B exists alone, and A and B exist simultaneously. In the description of the embodiments of this application, "multiple" refers to two or more. Example
[0033] Figure 1 shows a rapid hemostatic balloon provided by the present invention.
[0034] The rapid hemostasis balloon 100 includes a balloon catheter and an inflation dispensing assembly. The balloon catheter includes a catheter assembly and a balloon assembly. The balloon assembly is disposed on the catheter assembly, and the inflation dispensing assembly is disposed proximally to the catheter assembly.
[0035] The balloon assembly includes multiple balloons, each with an independent cavity. The balloons are made of an expandable material, such as natural rubber, synthetic rubber, silicone resin, latex, polyurethane, polyvinyl chloride, polyethylene, nylon, or any other expandable elastomer, polymer, or other material. Preferably, the balloons are made of silicone and have sufficient conformability to generally conform to the shape of the body cavity.
[0036] The catheter assembly is connected to an external inflation device for inflating and deflating the balloons in the aforementioned balloon assembly. The fluid inflated during balloon inflation can be liquid or gas, depending on the requirements. Specifically, the catheter assembly includes multiple balloon tubings, each corresponding to a balloon in the balloon assembly. Each balloon tubing connects its corresponding balloon to the inflation device 200, and each balloon tubing's inflation port is equipped with a control valve to open or close the inflation port.
[0037] In this embodiment, the balloon assembly includes at least one hemostatic balloon 110 and at least one anti-slip balloon 120. The hemostatic balloon 110 is disposed at the distal end of the catheter assembly 130 and wraps around the outer wall of the catheter assembly 130. The anti-slip balloon 120 is disposed corresponding to the hemostatic balloon 110 and is used to prevent the hemostatic balloon 110 from slipping out of the body cavity into which it is inserted.
[0038] Correspondingly, the balloon conduit of the catheter assembly 130 includes a hemostatic balloon conduit and an anti-slip balloon conduit. The hemostatic balloon conduit and the anti-slip balloon conduit are independent of each other. The output port at the distal end of the hemostatic balloon conduit is connected to the inner lumen of the hemostatic balloon, and the output port at the distal end of the anti-slip balloon conduit is connected to the inner lumen of the anti-slip balloon. An inflation port is provided at the proximal end of the hemostatic balloon conduit and the anti-slip balloon conduit.
[0039] The inflation dispensing assembly 140 is installed at the proximal end of the catheter assembly 130 and is located between the inflation device 200 and the inflation ports of each balloon conduit. The inflation dispensing assembly 140 is configured to: determine the target balloon to be inflated according to the received balloon inflation command; form an infusion path after docking with the balloon conduit inflation port corresponding to the target balloon to inflate the target balloon by infusing fluid, at which time the inflation port control valve of the target balloon is opened; and after the fluid inflation is completed, disconnect the aforementioned docking, and the inflation port control valve of the target balloon returns to the closed state.
[0040] As an example, and not a limitation, if the target balloon requiring inflation is determined to be the anti-slip balloon 120 according to the balloon inflation command, the inflation distribution assembly 140 first connects to the inflation port of the balloon tubing corresponding to the anti-slip balloon 120. After connection, an infusion path is formed, and then fluid is injected into the anti-slip balloon 120 to inflate it. At this time, the inflation port control valve of the target balloon opens. After the fluid inflation is completed, the inflation distribution assembly 140 can disconnect the aforementioned connection, and the inflation port control valve of the target balloon returns to the closed state.
[0041] In one embodiment, the control valve can be a one-way valve. After the anti-slip balloon tubing filling port is connected to the filling distribution assembly 140, the one-way valve of the filling port automatically opens to form an infusion passage, allowing fluid to be injected into the anti-slip balloon 120 through the filling distribution assembly 140 to inflate it; no manual filling connection or filling operation (such as using a syringe) is required. After filling is completed, the connection is released, and the one-way valve of the anti-slip balloon filling port automatically closes. In another embodiment, the control valve can also be a solenoid valve, which is connected to the controller of the filling distribution assembly 140 and can receive control from the controller. After the anti-slip balloon tubing filling port is connected to the filling distribution assembly 140, the controller controls the solenoid valve of the filling port to open to form an infusion passage, allowing fluid to be injected into the anti-slip balloon 120 through the filling distribution assembly 140 to inflate it; after filling is completed, the control valve of the anti-slip balloon filling port is closed, and the connection is released. It should be noted that the specific structure and opening / closing control of the check valve and solenoid valve can refer to various check valve and solenoid valve devices already existing in the field, which are prior art and will not be described in detail here.
[0042] When the balloon needs to be removed later, the fluid in the balloon must be released first. At this point, the inflation dispensing assembly 140 can be detached from the catheter assembly 130, separating the inflation dispensing assembly and inflation device from the catheter assembly. This exposes the balloon tubing inflation port at the proximal end of the catheter assembly, allowing for fluid release—for example, by connecting the balloon tubing inflation port to a fluid collection device. As an example, and not a limitation, when the fluid in the balloon is liquid, the balloon tubing inflation port can be connected to a collection bag for collecting the liquid. After the control valve is opened, the liquid in the balloon is released through the balloon tubing into the collection bag.
[0043] In this embodiment, the hemostatic balloon itself can adopt a multi-cavity structure, including a main balloon and multiple flattened auxiliary balloons disposed on the outer surface of the main balloon. The cavities of the main balloon and the flattened auxiliary balloons are independent of each other. Corresponding to the main balloon and the multiple flattened auxiliary balloons, independent main balloon conduits and multiple auxiliary balloon conduits can be respectively provided, with each auxiliary balloon conduit corresponding to a specific auxiliary balloon. The inflation port of the main balloon conduit can be connected to the aforementioned inflation and dispensing component to form an infusion pathway, and the inflation ports of each auxiliary balloon conduit can be connected to the aforementioned inflation and dispensing component to form an infusion pathway.
[0044] When the balloon catheter is used for hemostasis in the uterine cavity, the hemostasis balloon 110 is an intrauterine hemostasis balloon. In this case, the shape of the intrauterine hemostasis balloon is preferably configured to match the shape of the uterine cavity, and is a flat, inverted pear shape that is wider at the top and narrower at the bottom, with the anteroposterior diameter smaller than the left-right diameter.
[0045] As a typical example, as shown in Figure 2, the intrauterine hemostatic balloon includes a main balloon 111 and multiple flat auxiliary balloons disposed on the left and right sides of the main balloon 111. The shape and size of each flat auxiliary balloon can be the same. The multiple flat auxiliary balloons are arranged along the left and right sides of the main balloon, respectively, and the bottom of the flat auxiliary balloons is attached to the balloon wall of the main balloon, forming a left auxiliary balloon and a right auxiliary balloon.
[0046] The left and right accessory balloons can be symmetrically arranged relative to the main balloon. When inflatation is required, fluid is injected into the cavities of the main balloon, the left accessory balloon, and the right accessory balloon via the inflation dispensing assembly. After inflating, the main balloon primarily compresses the anterior and posterior walls of the uterus, while the left and right accessory balloons primarily compress the left and right lateral walls of the uterus, respectively. In particular, the inflating of the lower portions of the left and right accessory balloons effectively compresses the ascending branch of the uterine artery in the lower segment of the uterus, thus achieving effective hemostasis.
[0047] Preferably, Figure 2 illustrates the case where there are two auxiliary balloons on both the left and right sides. In this case, four flat auxiliary balloons are distributed on the surface of the main balloon 111. The upper part of the left and right auxiliary balloons corresponds to the uterine horn region of the uterine cavity for compression hemostasis in that region. The lower part of the left and right auxiliary balloons corresponds to the ascending branches of the uterine arteries on the left and right sides of the uterine cavity, respectively, for direct blockage of the ascending branches of the uterine arteries, thereby effectively stopping bleeding. In this way, compression hemostasis can be applied to specific areas based on the tissue characteristics of the uterine cavity and the location of bleeding, satisfying the regional adjustment requirements of the hemostasis balloon. More preferably, utilizing the balloon's expansion characteristics, the balloon wall in this embodiment can include a thickened area to guide the balloon to expand further into areas with thinner balloon walls. Specifically, the balloon wall in the connecting area between the main balloon and the flat auxiliary balloon can be thickened to limit the balloon's expandability in the connecting area. This guides the balloon's expansion to the non-connecting area where the balloon wall is thinner. When the balloon expands, the expansion of the non-connecting area is more pronounced. In this way, the intrauterine hemostatic balloon expands more outward when inflated, which can better compress the cavity wall.
[0048] It should be noted that the number and position of the left and right auxiliary balloons mentioned above are examples and not limitations. When designing hemostatic balloons, those skilled in the art can set more auxiliary balloons on the main balloon as needed, and are not limited to the left and right sides of the main balloon.
[0049] The anti-slip balloon, preferably a ring-shaped balloon, is placed inside the vagina, resembling a swimming ring. After inflating, the anti-slip balloon is secured within the vaginal fornix at the apex of the vagina and surrounds the cervix, simultaneously lifting the aforementioned intrauterine hemostatic balloon and closing the internal cervical os. In other words, the anti-slip balloon, after inflation, needs to form a structure capable of surrounding the cervical canal. Specifically, the inner cavity of the ring-shaped balloon body is used for fluid filling. The ring-shaped balloon body forms an inner ring whose dimensions match the outer periphery of the cervix at the vaginal fornix. Simultaneously, the dimensions of the ring-shaped balloon body match those of the vaginal fornix, allowing the anti-slip balloon to be secured within the vaginal fornix at the apex of the vagina and surround the cervix after inflation. An opening on the ring-shaped balloon body serves as an inflation port, allowing fluid from the anti-slip balloon tubing to enter the inner cavity of the ring-shaped balloon body, thereby causing the ring-shaped balloon to inflate.
[0050] Preferably, when used for uterine cavity hemostasis, the filling fluid of each balloon is a liquid—such as physiological saline.
[0051] Considering the need for drainage to stop bleeding in the uterine cavity, the catheter assembly 130 also includes a drainage tube 131, as shown in Figure 3. The distal end of the drainage tube 131 passes sequentially through the inner ring of the annular anti-slip balloon and the inner lumen of the intrauterine hemostasis balloon before extending outside the intrauterine hemostasis balloon. A drainage port is provided at the distal end of the drainage tube 131 (located in the uterine cavity) to drain the accumulated blood in the uterine cavity; one or more drainage ports may be provided as needed. The proximal end of the drainage tube is connected to the drainage device 300. Preferably, the length of the upper end of the drainage tube extending outside the intrauterine hemostasis balloon is 5-15 mm.
[0052] Each balloon conduit 132 of the catheter assembly can be set independently relative to the drainage tube 131, or it can be attached to the aforementioned drainage tube 131. Figure 3 illustrates the case where the balloon conduit 132 and the drainage tube 131 are set independently. In this case, the catheter assembly can be divided into balloon conduit lumens and drainage tube lumens. Multiple balloon conduits are arranged in the balloon conduit lumens, and the drainage tube lumens can directly form the drainage tube.
[0053] In this embodiment, each balloon in the balloon assembly is configured with a balloon name and / or balloon number. The balloon name and / or balloon number are set in a one-to-one correspondence with the balloon, and the corresponding balloon can be distinguished from other balloons through the balloon name and / or balloon number. As a typical example, the balloon numbering in the balloon assembly can be seen in Figure 4. The main balloon is numbered Xm1, and the number Xm1 can be mapped to the main balloon of the hemostasis balloon X in the balloon assembly. There are 4 auxiliary balloons, numbered Xn1, Xn2, Xn3, and Xn4 respectively, and the numbers Xn1, Xn2, Xn3, and Xn4 can be mapped to each auxiliary balloon of the hemostasis balloon X in the balloon assembly. There is only 1 anti-slip balloon, numbered Y1, and the number Y1 can be mapped to the anti-slip balloon in the balloon assembly. It should be noted that the above-described configuration of balloon numbers is an example and not a limitation. Those skilled in the art can adapt the data format of balloon names and / or balloon numbers as needed, as long as the balloon name and / or balloon number can be mapped to its corresponding specific balloon. The configuration of the data format of balloon names and / or balloon numbers should not be regarded as a limitation of the present invention.
[0054] At this time, the balloon inflation command includes the balloon name and / or balloon number of the target balloon that needs to be inflated with fluid, as well as the inflation parameter information of the target balloon.
[0055] The inflation parameter information may specifically include information such as the fluid type, inflation flow rate, inflation speed, and / or inflation time. When there are multiple target balloons to be inflated, the inflation parameter information may also include the inflation sequence information for the multiple target balloons.
[0056] In specific configurations, the inflation and distribution component can be equipped with a human-machine interface to collect user balloon inflation commands. In one embodiment, the human-machine interface is a button area on the inflation and distribution component. This button area has operation buttons for inflating multiple balloons. The user issues a balloon inflation command for a target balloon by triggering the corresponding button. For example, when the user needs to inflate the main balloon of the hemostatic balloon, they can press the operation button corresponding to the main balloon in the button area. The controller will then receive the balloon inflation command for the main balloon of the hemostatic balloon and initiate the inflation operation accordingly. Similarly, when the user needs to inflate the anti-slip balloon, they can press the operation button corresponding to the anti-slip balloon in the button area. The controller will then receive the balloon inflation command for the anti-slip balloon and initiate the inflation operation accordingly. In another embodiment, the human-machine interface includes a touch screen mounted on the inflation and dispensing component. The touch screen has a balloon inflation information acquisition section. After acquiring the user-inputted / selected balloon information (i.e., the target balloon) through this section, the interface sends an inflation command to the controller, specifying the target balloon—for example, the main balloon of a hemostatic balloon. Upon receiving the inflation command for the main balloon of the hemostatic balloon, the controller initiates the inflation operation of the main balloon according to the command.
[0057] Alternatively, the inflation distribution component can be communicatively connected to an associated user terminal to receive balloon inflation commands sent by that user terminal. In this case, the balloon inflation command may also include the user terminal's terminal ID information and user authentication information, whereby the user authentication information is used to verify the legality of the balloon inflation command. When the user authentication information verification fails, the inflation distribution component determines that the inflation command is illegal. At this point, the inflation distribution component sends verification failure information back to the user terminal corresponding to the aforementioned terminal ID and issues an alarm through an associated alarm. The alarm can be installed on the inflation distribution component or on other associated terminals, and the alarm information can be an audible and / or visual warning.
[0058] Referring to Figure 4, the filling and dispensing component may specifically include a controller and at least one filling dispenser, wherein the filling dispenser is connected to the controller and receives control from the controller.
[0059] The controller is configured to receive a balloon inflation command and determine one or more target balloons to be inflated based on the balloon inflation command.
[0060] The inflation dispenser includes a balloon inflation head, which is used to connect the balloon inflation head to the balloon tubing inflation port of the target balloon under the control of the controller to form an infusion path, and to inflate the target balloon with fluid according to the inflation parameters of the target balloon; and after the inflation is completed, to separate the balloon inflation head from the balloon tubing inflation port of the target balloon under the control of the controller.
[0061] Figure 5 illustrates a specific structure of a filler dispenser.
[0062] At this time, the balloon inlet ports of each balloon form a balloon inlet port array 133 at the proximal end of the catheter assembly, that is, multiple balloon inlet ports are arranged in a row along the axis of the slide bar, and the inlet distributor is an inlet distributor 142.
[0063] The filling dispenser 142 includes a slide bar 1421 and an electric slider 1422 mounted on the slide bar.
[0064] The slide bar 1421 is set at each balloon tube filling port corresponding to the linear array 133 of balloon tube filling ports, and the length of the slide bar 1421 matches the arrangement length of the balloon tube filling ports.
[0065] The electric slider 1422 includes a first drive unit and a second driver (not shown in the figure). The electric slider 1422 is capable of moving as a whole on the slide rod 1421. The first drive unit and the second driver can be miniature linear motors.
[0066] The first end of the slider section is fitted with the aforementioned balloon inflator head, namely the first balloon inflator head 1423, which is located near the balloon tubing inflator port. The second end of the slider section is connected to the output end of the inflator line 1424, and the input end of the inflator line 1424 is connected to the inflator device. A through-flow pipe is provided in the slider section to connect the inner cavity of the aforementioned first balloon inflator head 1423 and the inflator line 1424. Fluid sequentially passes through the inflator line 1424, the slider section pipe, and the inner cavity of the balloon inflator head before entering the balloon tubing inflator port.
[0067] The first actuator, under the control of the controller, drives the slider to move on the slide rod to reach the inflation port of the target balloon's tubing. The second actuator, under the control of the controller, drives the first balloon inflation head 1423 to move towards the inflation port of the target balloon's tubing to dock with it. After docking, the inflation port control valve of the target balloon opens to form an infusion passage, and fluid is injected into the current balloon through the inflation port 1423. The controller monitors the inflation process, and upon determining that inflation is complete, controls the second actuator to start, driving the first balloon inflation head 1423 to move in the opposite direction to separate from the inflation port of the target balloon's tubing.
[0068] After separation is complete, the controller can activate the first driver to move the slider on the slide bar to a target balloon position or return to the initial position.
[0069] Preferably, each balloon can also be equipped with an image acquisition cavity to allow a fiber optic probe to enter the balloon cavity and acquire body cavity image information. In this case, each balloon is made of transparent material.
[0070] The camera fiber (or imaging fiber bundle) and the light guide fiber (or illumination fiber bundle) are located in the image acquisition cavity. The fiber optic probe is located at the far end of the image acquisition cavity and enters the corresponding balloon cavity. At the same time, a connector for the camera fiber and the light guide fiber is provided at the balloon tube filling port for electrical connection, as shown in Figure 6.
[0071] At this time, the slider section also includes a camera connector and a light guide connector 1425, which are located around the first balloon inflation head 1423, for example, below, above, to the left, or to the right of the first balloon inflation head 1423. When the balloon tube inflation port is connected to the first balloon inflation head 1423, the camera connector and light guide connector 1425 around the first balloon inflation head 1423 are also connected to the connecting connectors of the camera fiber and the light guide fiber on the balloon tube inflation port for electrical connection. The other end of the camera connector and the light guide connector 1425 are connected to the external imaging equipment and the external light source respectively via the fiber optic mirror line 1426. In this way, when the balloon inlet is connected to the balloon inlet head, the fiber optic probe can be electrically connected to the external imaging equipment and external light source. The external imaging equipment can display the intrauterine image information collected by the probe, thereby enabling stable and real-time monitoring of the balloon expansion status, balloon position, intracavitary conditions, and other information during the balloon inlet filling process.
[0072] In another embodiment of this example, when the balloon inlet ports of each balloon form a circular array 134 of balloon inlet ports at the proximal end of the catheter assembly, as shown in Figure 7, another type of inlet dispenser is required.
[0073] Figure 8 illustrates the specific structure of the filler dispenser 2 144.
[0074] At this time, the filling distributor includes a multi-dimensional docking plate, and the aforementioned balloon filling head, namely the second balloon filling head 1441, is arranged on the upper surface of the multi-dimensional docking plate. Multiple balloon tube filling ports are arranged on the same plane and the plane is parallel to the upper surface of the multi-dimensional docking plate.
[0075] The multidimensional docking plate includes a sliding stage 1442, a rotating stage 1443, and a longitudinal shifter 1444, which are controlled by a controller.
[0076] In a specific configuration, the second balloon inflator 1441 is mounted on the sliding platform 1442 of the multidimensional docking plate via a lateral movement mechanism. This lateral movement mechanism drives the balloon inflator to move laterally on the sliding platform. The sliding platform 1442 is mounted on a rotating platform 1443, which drives the sliding platform 1442 to rotate, thereby rotating the second balloon inflator 1441. The rotating platform 1443 is mounted on a longitudinal shifter 1444, which drives the rotating platform 1443 to move longitudinally, thereby engaging or disengaging the second balloon inflator 1441 with or from the balloon tubing inflator. When the balloon inflator separates from the balloon tubing inflator, the fluid injection operation stops.
[0077] At this time, the controller is configured to: after determining that the target balloon needs to be inflated, control the sliding stage and / or rotating stage of the multi-dimensional docking plate to adjust the position of the balloon inflation head in the lateral and / or circumferential directions respectively so that it moves to the balloon tube inflation port of the target balloon, and control the longitudinal shifter of the multi-dimensional docking plate to drive the balloon inflation head to dock with the balloon tube inflation port of the target balloon, and inject fluid into the balloon tube inflation port after docking is completed.
[0078] In this embodiment, when each balloon tube is provided with an image acquisition cavity (for the passage of camera fibers and light guide fibers), a connector for the camera fibers and light guide fibers is also provided at each balloon tube filling port for electrical connection. At this time, the aforementioned camera connector and light guide connector can also be provided around the balloon filling head on the upper surface of the multi-dimensional docking plate. The camera connector and light guide connector can be located below, above, to the left, or to the right of the balloon filling head. When the balloon filling head is docked with a balloon tube filling port, the camera connector and light guide connector around the balloon filling head also dock with the connectors for the camera fibers and light guide fibers on the aforementioned balloon tube filling port for electrical connection; the other end of the camera connector and light guide connector can be connected to an external imaging device and an external light source via fiber optic mirror lines, respectively.
[0079] In another embodiment of this invention, the filling dispenser is a rotating docking plate. In this case, the rotating docking plate may include a rotating section and a rotating drive structure. The rotating drive structure is used to drive the rotating section to rotate. Multiple balloon tube filling ports are set corresponding to the rotating section and are located at different positions of the rotating section.
[0080] Specifically, the rotating section may include an input end and an output end, which are connected through an internal cavity within the rotating section. The input end is used to connect to the inflation device, and the rotating drive structure, under the control of the controller, drives the rotating section to rotate so that the output end connects to the inflation ports of the balloon tubing at different locations. When the output end connects to the inflation port of the target balloon tubing, the inflation port control valve of the target balloon opens, and fluid enters the balloon tubing through the rotating section and is then introduced into the target balloon.
[0081] In this embodiment, when each balloon tube is provided with an image acquisition cavity (for the passage of camera fibers and light guide fibers), a connector for the camera fibers and light guide fibers is also provided at each balloon tube filling port for electrical connection. At this time, the aforementioned camera connector and light guide connector can also be provided near the output end of the rotating section. When this output end is connected to a balloon tube filling port, the camera connector and light guide connector near the output end are also connected to the connectors for the camera fibers and light guide fibers on the aforementioned balloon tube filling port for electrical connection; the other ends of the camera connector and light guide connector are connected to external imaging equipment and external light source respectively via fiber optic mirror lines.
[0082] In this embodiment, the multiple balloons in the balloon assembly can also be configured with type attribute information, meaning the balloons are divided into multiple types. In this case, a dedicated inflation dispenser can be configured for each type of balloon, and multiple balloons of the same type are inflated with fluid through their dedicated inflation dispensers. All multiple inflation dispensers are connected to and receive control from the controller. The balloon inflation command can also include the balloon type attribute information. Based on this type attribute information, the controller controls the corresponding dedicated inflation dispenser to inflate the target balloon with fluid. Thus, on the one hand, multiple inflation dispensers can simultaneously inflate multiple types of balloons in parallel, improving inflation efficiency; on the other hand, different inflation dispensers can be configured to inflate different types of balloons with different fluids, meeting the inflation needs of more application scenarios.
[0083] Another embodiment of the present invention provides a balloon dilation system for uterine cavity hemostasis, the system comprising an inflatable balloon and a balloon dilation control device.
[0084] The expandable balloon is the aforementioned rapid hemostatic balloon, and the balloon assembly includes a hemostatic balloon for insertion into the uterine cavity and an anti-slip balloon for insertion into the vagina.
[0085] The balloon expansion control device includes a user-facing host computer—such as a PC—which displays information about each balloon in the balloon assembly. After receiving a balloon inflation command from the user for one or more balloons, the host computer sends the balloon inflation command to the aforementioned rapid hemostasis balloon inflation and dispensing assembly.
[0086] As a typical example, the host computer's display screen can show a list of balloons containing balloon components, displaying information about each balloon. At the same time, operation options are set for each balloon in the balloon list, and the user's selection information for the balloons is collected through the operation options—for example, the user selects one or more balloons in the balloon list by triggering the operation options with the mouse. These selected balloons are the target balloons that need to be inflated with fluid.
[0087] Furthermore, each balloon in the balloon list is equipped with an inflation parameter acquisition section. After selecting a target balloon, the user can configure its inflation parameters through this section. The inflation parameters may specifically include the fluid type, flow rate, inflation speed, and / or inflation time. When multiple target balloons are selected, the inflation parameters may also include the inflation sequence information. This inflation sequence parameter can be configured by the user according to hemostasis requirements.
[0088] In this embodiment, when the catheter assembly of the balloon catheter is a flexible catheter, the system may further include a balloon propulsion device. The balloon propulsion device is detachably connected to the catheter assembly and is used to attach to or insert into the catheter assembly during balloon placement to support the catheter assembly, thereby guiding the aforementioned intrauterine hemostasis balloon to the fundus or upper segment of the uterine cavity.
[0089] Optionally, the balloon propulsion device is a guide tube. A guide tube lumen can be provided on the drainage tube of the catheter assembly for insertion. The guide tube has a higher rigidity than the drainage tube of the catheter assembly to improve the bending resistance and toughness of the balloon catheter insertion. After the balloon is inserted in place, the guide tube can be separated from the catheter assembly for removal. The guide tube is provided with graduations to indicate the position of the balloon in the uterine cavity.
[0090] Optionally, the system may also include a cervical ligation band for horizontal ligation of the cervix to close the internal cervical os. Specifically, the cervical ligation band can be a wide nylon band connected to a catheter assembly (such as a drainage tube), positioned corresponding to the anti-slip balloon. After the hemostatic balloon is placed in the uterine cavity, it is first inflated with an appropriate amount of fluid to ensure the balloon is located in the upper segment or fundus of the uterus. Then, the cervix is ligated horizontally within the vagina, close to the fornix and as close as possible to the internal cervical os, to prevent slippage. The hemostatic balloon is then inflated until it is completely fitted into the uterine cavity. Ligating the cervix directly with the ligation band eliminates the need for sutures, reducing damage to the cervix. Furthermore, for patients with postpartum hemorrhage after vaginal delivery, especially those with cervical lacerations, this ligation can stop the bleeding without requiring cervical sutures.
[0091] Preferably, the cervical ligation band includes a ligation ring and a telescopic buckle, the telescopic buckle being able to adjust the tightness of the ligation ring.
[0092] During use, after placing the uninflated hemostatic balloon into the uterine cavity, first inflate the main balloon with an appropriate amount of fluid using the inflation dispensing device to ensure the hemostatic 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 hemostatic balloon from slipping out. Continue to inflate the main and auxiliary balloons until the balloon 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 anti-slip balloon inside the vagina to secure it within the vaginal fornix. The anti-slip balloon lifts the hemostatic balloon inside the uterine cavity and further strengthens the closure of the internal cervical os by the ligation band. Under the dual action of the ligation band and the anti-slip balloon, the internal cervical os is better closed, thus preventing the hemostatic balloon from slipping out of the uterine cavity. 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.
[0093] When removing the hemostatic balloon, first release the fluid from the hemostatic balloon in the uterine cavity, then release the fluid from the anti-slip balloon, and finally remove the cervical ligation band.
[0094] Other technical features are described in the preceding embodiments and will not be repeated here.
[0095] 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 rapid hemostasis balloon, comprising a balloon catheter, the balloon catheter including a catheter assembly and a balloon assembly, the balloon assembly being disposed on the catheter assembly, the catheter assembly being for connection to an external inflation device, characterized in that: The balloon assembly includes multiple balloons, and the cavities of the multiple balloons are independent of each other; The catheter assembly includes multiple balloon tubings, with each balloon tubing corresponding to a balloon. Each balloon tubing connects its corresponding balloon to the aforementioned inflation device, and each balloon tubing has an inflation port equipped with a control valve. It also includes an inflation distribution assembly disposed between the inflation device and the inflation ports of each balloon tubing. The inflation distribution assembly is configured to: determine the target balloon to be inflated according to the received balloon inflation command; form an infusion passage after docking with the balloon tubing inflation port corresponding to the target balloon to inflate the target balloon with fluid, at which time the inflation port control valve of the target balloon is opened; and after the fluid inflation is completed, disconnect the aforementioned docking and the inflation port control valve of the target balloon is returned to the closed state.
2. The rapid hemostatic balloon according to claim 1, characterized in that: The balloon assembly includes at least one hemostatic balloon and at least one anti-slip balloon, and the catheter assembly includes a hemostatic balloon conduit and an anti-slip balloon conduit. The hemostatic balloon includes a main balloon and multiple flat auxiliary balloons disposed on the outer surface of the main balloon. The cavities of the main balloon and the flat auxiliary balloons are independent of each other. Corresponding to the main balloon and the multiple flat auxiliary balloons, there are independent main balloon channels and multiple auxiliary balloon channels. The auxiliary balloon channels are configured one-to-one with the auxiliary balloons. The inflation port of the main balloon channel can be connected to the aforementioned inflation and dispensing component to form an infusion pathway. The inflation ports of each auxiliary balloon channel can be connected to the aforementioned inflation and dispensing component to form an infusion pathway.
3. The rapid hemostatic balloon according to claim 2, characterized in that: The balloon catheter is used for hemostasis in the uterine cavity. At this time, the hemostasis balloon is an intrauterine hemostasis balloon. The intrauterine hemostasis balloon includes a main balloon and multiple flat auxiliary balloons arranged on the left and right sides of the main balloon. The multiple flat auxiliary balloons are arranged along the left and right sides of the main balloon, and the bottom of the flat auxiliary balloons is attached to the balloon wall of the main balloon. The anti-slip balloon is placed inside the vagina. The anti-slip balloon is a ring-shaped balloon. After expansion, it is fixed in the vaginal fornix at the top of the vagina and surrounds the cervix. While lifting the aforementioned intrauterine hemostatic balloon, it closes the internal os of the cervix. The catheter assembly also includes a drainage tube, the distal end of which passes through the inner ring of the annular anti-slip balloon and the inner lumen of the intrauterine hemostatic balloon in sequence, and then extends out of the intrauterine hemostatic balloon. A drainage port is provided at the distal end of the drainage tube, and the proximal end of the drainage tube is connected to a drainage device.
4. The rapid hemostatic balloon according to claim 3, characterized in that: The intrauterine hemostatic balloon is shaped to match the shape of the uterine cavity, and is a flat, inverted pear shape that is wider at the top and narrower at the bottom, with the anteroposterior diameter smaller than the lateral diameter.
5. The rapid hemostatic balloon according to any one of claims 1-4, characterized in that: Each balloon in the balloon assembly is configured with a balloon name and / or balloon number, and the balloon name and / or balloon number are set in a one-to-one correspondence with the balloon. The corresponding balloon can be located by the balloon name and / or balloon number. The balloon inflation command includes the name and / or number of the target balloon to be inflated with fluid, as well as the inflation parameter information of the target balloon.
6. The rapid hemostatic balloon according to claim 5, characterized in that: The filling and dispensing assembly includes a controller and at least one filling dispenser, wherein the filling dispenser is connected to the controller and receives control from the controller; The controller is configured to receive a balloon inflation command and determine one or more target balloons to be inflated based on the balloon inflation command. The inflation dispenser includes a balloon inflation head, which is used to connect the balloon inflation head to the balloon tubing inflation port of the target balloon under the control of the controller to form an infusion path, and to inflate the target balloon with fluid according to the inflation parameters of the target balloon; and after the inflation is completed, to separate the balloon inflation head from the balloon tubing inflation port of the target balloon under the control of the controller.
7. The rapid hemostatic balloon according to claim 6, characterized in that, The filling dispenser includes: The slide bar is set with the balloon tubing inflation port of each balloon, and multiple balloon tubing inflation ports are arranged in a row along the axis of the slide bar; An electric slider mounted on a sliding rod includes a slider section, a first drive section, and a second drive unit. The first end of the slider section is fitted with the aforementioned balloon inflation head, and this first end is located near the balloon tubing inflation port. The first drive unit, under the control of a controller, drives the slider section to move along the sliding rod to reach the balloon tubing inflation port position of the target balloon. The second drive unit, under the control of the controller, drives the balloon inflation head to move towards the balloon tubing inflation port of the target balloon to mate with the balloon tubing inflation port. After mate-mate, the balloon inflation port control valve opens, and fluid is inflated through the balloon inflation head. After inflation, the second drive unit, under the control of the controller, drives the balloon inflation head to move in the opposite direction to separate from the balloon tubing inflation port of the target balloon. The first drive unit, under the control of the controller, drives the slider section to move along the sliding rod to a target balloon position or return to its initial position.
8. The rapid hemostatic balloon according to claim 7, characterized in that: Each balloon is equipped with an image acquisition cavity for the fiber optic probe to enter the balloon cavity. Each balloon is made of transparent material. The camera fiber and the light guide fiber are located in the image acquisition cavity. The fiber optic probe is located at the far end of the image acquisition cavity and enters the corresponding balloon cavity. At the same time, the connection connector of the camera fiber and the light guide fiber is set at the balloon filling port. The slider section also includes a camera connector and a light guide connector, which are located around the balloon filling head. When the balloon tube filling port is connected to the balloon filling head, the camera connector and the light guide connector are also connected to the connecting connectors of the camera fiber and the light guide fiber, respectively, for electrical connection.
9. The rapid hemostatic balloon according to claim 6, characterized in that: The filling dispenser includes a multi-dimensional docking plate. The aforementioned balloon filling head is disposed on the upper surface of the multi-dimensional docking plate. Multiple balloon tubing filling ports are disposed on the same plane, which is parallel to the upper surface of the multi-dimensional docking plate. The multi-dimensional docking plate includes a sliding table, a rotating table, and a longitudinal shifter. The sliding table, rotating table, and longitudinal shifter are controlled by a controller. The balloon filling head is mounted on the sliding table of the multi-dimensional docking plate via a lateral movement mechanism, which drives the balloon filling head to move laterally on the sliding table. The sliding table is mounted on the rotating table, which drives the sliding table to rotate, thereby rotating the balloon filling head. The rotating table is mounted on the longitudinal shifter, which drives the rotating table to move longitudinally, thereby causing the balloon filling head to dock with or separate from the balloon tubing filling port. When the balloon filling head separates from the balloon tubing filling port, the fluid injection operation stops. Alternatively, the filling dispenser includes a rotating docking plate, which comprises a rotating section and a rotating drive structure. The rotating drive structure drives the rotating section to rotate, and multiple balloon tube filling ports are arranged corresponding to the rotating section and located at different positions on the rotating section. The rotating section includes an input end and an output end. The input end is used to connect to the filling device, and the rotating drive structure can drive the rotating section to rotate under the control of the controller so that the output end is connected to the balloon tube filling ports at different positions. When the output end is connected to the target balloon tube filling port, the filling port control valve of the target balloon opens, and fluid enters the balloon tube through the rotating section and is then input into the target balloon.
10. A balloon dilation system for uterine cavity hemostasis, characterized in that... include: An expandable bladder, wherein the expandable bladder is the rapid hemostatic balloon according to any one of claims 1-9; The balloon expansion control device includes a user-facing host computer that displays information about each balloon in the balloon assembly. After receiving a balloon inflation command from the user for one or more balloons, the host computer sends the balloon inflation command to the inflation and dispensing component of the aforementioned rapid hemostasis balloon.
Citation Information
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