An intrauterine balloon device, system and method for assisted childbirth

Abstract

The application relates to the field of medical devices, and discloses an intrauterine balloon device, system and method for delivery assistance, which comprises a device main body, the device main body comprising a main pipe body, a compression balloon, a control balloon, a compression cavity pipe, a control cavity pipe and a drug delivery catheter; wherein the distal end of the drug delivery catheter is provided with an annular opening, and the inside of the distal end of the drug delivery catheter is provided with a plurality of integrally-formed shear blocks; after flowing through the shear blocks, the drug liquid is cut into fine liquid particles and sprayed out of the annular opening to form a drug mist; the annular opening is arranged on the balloon wall of the control balloon, the deformation of the control balloon drives the spatial position and orientation of the annular opening to change, so that the adjustment of the drug liquid penetration position is realized. Through the arrangement of the compression balloon and the control balloon, targeted drug intervention can be carried out on the compression dead cavity and stubborn bleeding points while the basic compression is maintained, the combination of wound compression and point-surface drug liquid assistance is realized, and the success rate of treatment of postpartum hemorrhage cases can be improved.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more particularly to an intrauterine balloon device, system, and method for assisting childbirth. Background Technology

[0002] Postpartum hemorrhage is the leading cause of maternal death worldwide, with uterine atony being the most common cause. After delivery, numerous blood sinuses open at the placental separation site, and effective contraction of the uterine muscle layer is crucial for closing these blood vessels and stopping the bleeding. If uterine atony occurs, it can lead to fatal hemorrhage.

[0003] Intrauterine balloon compression is currently a conservative treatment option for postpartum hemorrhage. Its basic principle is to insert a balloon into the uterine cavity and inflate it to apply physical pressure to the uterine wall, thereby mechanically compressing the bleeding point.

[0004] However, because the uterine cavity is an irregularly shaped inverted triangle, wider at the top and narrower at the bottom, traditional balloons, after inflation, are mostly spherical or pear-shaped, making it difficult to perfectly fit the anatomical structure of the uterine cavity. This leads to the easy formation of "dead spaces" that are not effectively compressed in the uterine horns on both sides of the fundus and between the balloon and the anterior and posterior walls of the uterus. Blood sinuses in these dead space areas will continue to bleed, and the uniform pressure of the balloon cannot be effectively transmitted to these areas, thus greatly reducing the overall hemostasis effect. Traditional balloons have very limited solutions to this problem, usually only attempting to improve the fit through over-inflation, but this significantly increases the risk of patient pain, tissue ischemia and necrosis, and even uterine rupture. Specifically, traditional balloons provide basic "surface" compression, but lack the ability to accurately identify and target bleeding located in dead spaces or at specific "points".

[0005] In conclusion, a new solution is urgently needed to address the aforementioned problems. Summary of the Invention

[0006] This invention overcomes the shortcomings of the prior art and provides an intrauterine balloon device, system, and method for assisting childbirth.

[0007] To achieve the above objectives, firstly, the present invention provides an intrauterine balloon device for assisting childbirth, comprising: a device body, the device body including a main tube, a compression balloon fixedly connected to the end of the main tube, a control balloon arranged parallel to the compression balloon along the axial direction of the main tube, a compression cavity tube disposed within the main tube and communicating distally with the interior of the compression balloon, a control cavity tube disposed within the main tube and communicating distally with the interior of the control balloon, and a drug delivery catheter terminated at the maximum inflatable and contractile deformable portion of the control balloon; wherein,

[0008] The drug delivery catheter is disposed within the main body, and its distal end extends to the outside of the control balloon and has an annular opening. The distal end of the drug delivery catheter has several integrally formed shearing blocks inside. After the drug flows through the shearing blocks, it is cut into fine liquid particles and sprayed out from the annular opening at the end to form a drug mist. The annular opening is disposed on the wall of the control balloon. When fluid is filled or released into the control balloon, the deformation of the control balloon causes the spatial position and orientation of the annular opening to change, thereby adjusting the penetration position of the drug.

[0009] In a preferred embodiment of the present invention, the shearing block is a columnar, wing-shaped, or spiral structure fixed in the internal channel of the drug delivery catheter, and a narrow gap for the drug solution to pass through is formed between the outer edge of the shearing block and the inner wall of the drug delivery catheter.

[0010] In a preferred embodiment of the present invention, the drug delivery catheter segment where the annular opening is located is fixed to the balloon wall of the control balloon by a biocompatible adhesive or integrally formed, so that the drug delivery catheter where the annular opening is located and the control balloon move in coordination with each other under deformation.

[0011] In a preferred embodiment of the present invention, the control balloon is fixed on the main tube at a position relative to the compression balloon toward a deeper part of the uterus, and the control balloon and the compression balloon are in partial contact or have a gap when inflated.

[0012] In a preferred embodiment of the present invention, the control balloon is configured to be one or more independently inflatable and deflated;

[0013] When the number of control balloons is one, the control balloon is an annular balloon arranged around the main body. The orientation of the annular opening can be adjusted by controlling the expansion or contraction of the control balloon at different circumferential positions.

[0014] When the number of control balloons is greater than one, the control balloons are arranged in a ring array around the main body, and the orientation of the ring opening is adjusted by selectively inflating and deflating different control balloons.

[0015] In a preferred embodiment of the present invention, an external control unit is further included, the external control unit comprising:

[0016] A precision pump, which is connected to the proximal end of a drug delivery catheter, for dispensing a drug solution;

[0017] Two fluid control modules are respectively connected to the inner cavities of the compression balloon and the control balloon. The fluid control modules are connected to the proximal ends of the control tube and the compression tube, and are used to precisely control the inflation and deflation of the control balloon and the compression balloon.

[0018] In a preferred embodiment of the present invention, the fluid control module includes an inflatable balloon that is sealed to the proximal end of the compression chamber or control chamber, a one-way valve disposed on the connection passage between the outlet of the inflatable balloon and the compression chamber or control chamber, and a pressure relief valve mounted on the valve body of the one-way valve. The operating knob of the pressure relief valve is located externally and is used to manually open it to release the fluid in the compression balloon.

[0019] In a preferred embodiment of the present invention, the control balloon is made of highly elastic medical-grade silicone, and the wall thickness of the most expandable and contractile deformable part of the control balloon is smaller than that of other parts.

[0020] Secondly, this application provides an intrauterine balloon system for assisting childbirth, including the balloon device as described above; and an observation component for observing intrauterine conditions, the observation component including a fiber endoscope, the endoscope of which is arranged parallel to the main body, the distal lens of which is located at the distal end of the compression balloon, with the field of view facing the inside of the uterine cavity, so as to observe the condition of the uterine wall, bleeding points and the adhesion of the drug mist after the balloon is in place.

[0021] Thirdly, this application provides a method for assisted delivery hemostasis using the aforementioned intrauterine balloon system, comprising the following steps: S1: After delivery of the fetus, the main body of the device is placed into the uterine cavity of the mother; S2: The main bleeding area in the uterine cavity is observed and located through the field of view of the observation component; S3: Fluid is injected into the compression balloon through the compression tube to inflate it and apply basic compression to the uterine wall for hemostasis; S4: With the real-time visual assistance of the observation component, the shape of the control balloon is adjusted through the control tube to precisely align the annular opening of the drug delivery catheter with the main bleeding area located in S2; S5: Hemostatic drug solution is delivered to the target bleeding area through the drug delivery catheter. The drug solution is atomized and sprayed out, adhering to the uterine wall; S6: The bleeding situation is continuously observed through the observation component. If the bleeding is significantly reduced or stopped, proceed to S7; if there is still active bleeding, repeat S4 and S5, and adjust the drug delivery target area for supplementary drug delivery; S7: After confirming that the bleeding is effectively controlled, the balloon compression state is maintained for a period of time; S8: First, empty the control balloon, then slowly empty the compression balloon, while monitoring for any recurrence of active bleeding through the observation component. Once safety is confirmed, remove the main body of the device from the uterine cavity.

[0022] This invention addresses the shortcomings of the prior art and has the following beneficial effects:

[0023] (1) This application separates basic compression and precise drug delivery by setting up a compression balloon and a control balloon with independent functions. The compression balloon first inflates to achieve full-area compression of the uterine cavity to control most of the bleeding. The control balloon then adjusts the spatial orientation of the annular opening of the drug delivery catheter through deformation. This design breaks through the technical limitation that traditional single balloons can only provide uniform static compression. It enables targeted drug intervention on compression dead space and refractory bleeding points while maintaining basic compression, thereby achieving the combination of area compression and point treatment, which significantly improves the success rate of treatment for complex postpartum hemorrhage cases.

[0024] (2) This application sets an integrally formed shear block structure inside the drug delivery catheter. When the drug flows through the narrow gap formed by the shear block and the tube wall, it generates a violent shearing action, breaking the drug into micron-sized atomized particles. This purely mechanical atomization scheme eliminates the need for traditional atomization elements that require external energy. It achieves efficient atomization of the drug in a limited space, which not only ensures the uniform adhesion and rapid absorption of the drug on the tissue surface, but also avoids the side effects of systemic drug delivery, providing a new technical path for intrauterine local drug treatment.

[0025] (3) This application integrates a fiber optic endoscope or electronic endoscope with a balloon device to construct a visual operating system. The endoscope is embedded in the main tube and the distal lens is located at the distal end of the main tube, providing a real-time view inside the uterine cavity. This solves the defects of blind operation in traditional balloon operation, enabling doctors to directly observe the location of bleeding points, assess the compression effect and monitor the adhesion of the drug mist, forming a closed-loop treatment mode of "observation-positioning-intervention-verification", which greatly improves the accuracy of operation and the controllability of treatment.

[0026] (4) This application adopts a ring-shaped balloon or a ring array control balloon configuration. By selectively filling and releasing different circumferential areas, the direction of drug delivery can be precisely controlled, ensuring accurate supply of drug to the bleeding point. It can effectively cover the pressure dead zone of traditional balloons such as the fundus and horn of the uterus, thereby solving the treatment blind zone problem of fixed nozzle devices and expanding the applicable scope of balloon devices. Attached Figure Description

[0027] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0028] Figure 1 This is a perspective structural diagram of a preferred embodiment of the present invention;

[0029] Figure 2 yes Figure 1Enlarged diagram of section A in the middle;

[0030] In the diagram: 1. Main body; 11. Pressure relief valve; 2. Compression balloon; 21. Compression lumen; 3. Control balloon; 31. Control lumen; 4. Drug delivery catheter; 41. Shear block; 42. Precision pump; 5. Observation assembly; 51. Fiberoptic endoscope; 6. Fluid control module. Detailed Implementation

[0031] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0032] Many specific details are set forth in the following description in order to provide a full understanding of the invention. However, the invention may also be practiced in other ways different from those described herein. Therefore, the scope of protection of the invention is not limited to the specific embodiments disclosed below.

[0033] In the description of this application, it should be understood that the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicating orientation or positional relationships based on the orientation or positional relationships shown in the accompanying drawings, are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as limiting the scope of protection of this application. Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Therefore, features defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0034] In the description of this application, it should be noted that, unless otherwise expressly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to the internal communication between two components. Those skilled in the art will understand the specific meaning of the above terms in this application based on the specific circumstances.

[0035] Exemplary device:

[0036] like Figure 1 , Figure 2 As shown, an intrauterine balloon device for assisting childbirth includes: a main body, comprising a main tube 1, a compression balloon 2 fixedly connected to the end of the main tube 1, a control balloon 3 arranged parallel to the compression balloon 2 along the axial direction of the main tube 1, a compression cavity tube 21 disposed within the main tube 1 and communicating distally with the interior of the compression balloon 2, a control cavity tube 31 disposed within the main tube 1 and communicating distally with the interior of the control balloon 3, and a drug delivery catheter 4 terminated at the maximum inflatable and contractile deformable portion of the control balloon 3; wherein,

[0037] The drug delivery catheter 4 is disposed inside the main body 1. The distal end of the drug delivery catheter 4 extends into the interior of the control balloon 3 and is provided with an annular opening. The distal end of the drug delivery catheter 4 is provided with several integrally formed shearing blocks 41. After the drug flows through the shearing blocks 41, it is cut into fine liquid particles and sprayed out from the annular opening to form a drug mist. The annular opening is disposed on the balloon wall of the control balloon 3. When the control balloon 3 is filled or released with fluid, the deformation of the control balloon 3 causes the spatial position and orientation of the annular opening to change, thereby realizing the adjustment of the drug penetration position.

[0038] Based on the above configuration, the device of this application decomposes the traditional single balloon into a functionally independent compression balloon 2 and control balloon 3. The compression balloon 2 rapidly inflates and fills the uterine cavity, applying uniform static pressure to stop most of the diffuse bleeding, thereby creating a stable environment with reduced bleeding for all subsequent delicate operations. Then, by combining the control balloon 3 with the drug delivery catheter 4, the balloon 3 is controlled by inflation and deflation to deform specific parts, thereby changing the spatial position and spray direction of the annular opening of the drug delivery catheter 4 fixed thereon. At this time, the drug solution is divided into fine liquid particles when flowing through the integrally formed shear block 41 inside the drug delivery catheter 4, and finally sprayed out through the direction-adjustable annular opening to form an atomized drug field covering a specific target area. This allows the doctor to independently adjust the spray target point of the drug mist while maintaining balloon compression, achieving precise drug intervention on the compression dead space and refractory bleeding points in the uterine cavity.

[0039] Specifically, in the drug delivery conduit 4, the shear block 41 is a columnar, wing-shaped, or spiral structure fixed in the internal channel of the drug delivery conduit 4. Its outer edge forms a narrow gap between itself and the inner wall of the drug delivery conduit 4, which constitutes a flow resistance structure. When the drug flows through the narrow gap under pressure, the fluid velocity increases sharply and the internal shear stress is significantly enhanced. This stress overcomes the surface tension and cohesion of the drug, tearing and breaking the entire flow into tiny liquid particles, thus achieving drug atomization.

[0040] Furthermore, the catheter segment containing the annular opening is fixed to the balloon wall of the control balloon 3 with a biocompatible adhesive or integrally molded, so that the deformation of this part of the catheter and the control balloon 3 moves in tandem. This connection structure establishes a direct motion relationship between the deformation of the control balloon 3 and the annular nozzle, so that when the control balloon 3 is controlled to expand or contract, the stretching and deformation of the balloon wall causes the annular nozzle at the end of the drug delivery catheter 4 to change the opening angle, ensuring that the spatial position of the annular opening and the spray angle change synchronously with the deformation of the balloon, realizing real-time linkage between nozzle orientation adjustment and balloon shape change.

[0041] Furthermore, the control balloon 3 is fixed to the main tube 1 at a position relative to the compression balloon 2 towards the deeper side of the uterus, and the control balloon 3 and the compression balloon 2 are in partial contact or have gaps when inflated. The control balloon 3, located deeper in the uterus, is closer to the fundus and horn of the uterus, which are the areas where the traditional compression balloon 2 is most likely to form compression dead space. This position allows the annular nozzle of the drug delivery catheter 4 integrated on the control balloon 3 to directly face these key areas, creating good spatial conditions for precise drug delivery.

[0042] Furthermore, the control balloon 3 is configured as one or more independently inflatable units. When there is only one control balloon 3, it is an annular balloon surrounding the main tube 1, and the orientation of the annular opening is adjusted by controlling the expansion or contraction of different circumferential positions of the control balloon 3. When there are multiple control balloons 3, they are arranged in a parallel annular array surrounding the main tube 1, and the orientation of the annular opening is adjusted by selectively inflating or contracting different control balloons 3. Based on the above configuration, when using a single annular balloon, the orientation of the annular opening is adjusted by controlling the expansion or contraction of different circumferential areas of the annular balloon surrounding the main tube 1. Inflation and deflation cause uniform local deformation of the balloon, which in turn drives the annular opening fixed to it to deflect evenly, achieving uniform coverage of the medication. When multiple independent annular array control balloons 3 are used, the inflation degree of each control balloon 3 is controlled differently. The difference in expansion of the control balloons 3 forms a combined thrust, which achieves precise control of the orientation of the annular opening. This allows the device to autonomously adjust the direction of drug delivery within the uterine cavity, thereby accurately covering bleeding points in various complex anatomical locations from the fundus to the lateral wall, solving the treatment blind spot problem caused by the fixed nozzle of traditional devices.

[0043] Furthermore, the main body of the device in this application also includes an external control unit, which includes: a precision pump 42, which is connected to the proximal end of the drug delivery catheter 4 for pushing the drug solution; two fluid control modules 6 respectively connected to the chambers of the compression balloon 2 and the control balloon 3, which are connected to the proximal ends of the control chamber tube 31 and the compression chamber tube 21 for precisely controlling the inflation and deflation of the control balloon 3 and the compression balloon 2; specifically, the fluid control module 6 includes an inflatable balloon that is sealed to the proximal end of the compression chamber tube 21 or the control chamber tube 31, a one-way valve disposed on the connection passage between the outlet of the inflatable balloon and the compression chamber tube 21 or the control chamber tube 31, and a pressure relief valve 11 mounted on the valve body of the one-way valve, wherein the operating knob of the pressure relief valve 11 is located at Externally, it is used to manually open and release the fluid inside the compression balloon 2. Based on the above settings, the precision pump 42 is responsible for pushing the drug solution from the drug delivery catheter 4 with a stable pressure and flow rate. In the fluid control module 6, the inflatable balloon generates pressure by manual pressing. The one-way valve is in the direction of opening from the inflatable balloon towards the uterus. It is used to ensure that the fluid is injected into the target balloon in one direction and maintain stable pressure. The pressure relief valve 11 provides a controllable pressure relief channel, so that the compression balloon 2 can quickly establish basic pressure, while allowing the control balloon 3 to achieve fine deformation adjustment. The three work together to ensure the accuracy of drug delivery and atomization stability, while maintaining the intuitiveness of operation and system reliability. Ultimately, it achieves precise control of the entire process from compression to drug delivery in an emergency clinical environment.

[0044] Furthermore, the control balloon 3 is made of highly elastic medical-grade silicone. The wall thickness of the most expandable and deformable part of the control balloon 3 is smaller than that of other parts. The highly elastic silicone gives the balloon sufficient deformation ability to adapt to complex uterine cavity shapes, while the thinning of the wall thickness in specific parts creates a preset deformation guidance zone. This allows the balloon to preferentially generate concentrated and controllable deformation in the deformation guidance zone during inflation and deflation, thereby converting limited volume changes into effective deflection displacement of the annular opening. This ensures both the sensitivity and accuracy of angle adjustment and the structural reliability of the control balloon 3 during repeated deformation.

[0045] Exemplary system:

[0046] An intrauterine balloon system for assisting childbirth includes the exemplary balloon device described above, and an observation component 5 for observing intrauterine conditions; wherein, the observation component 5 includes a fiber scope 51 or an electronic scope, the scope body of the fiber scope 51 or the electronic scope is arranged parallel to the main body 1, the distal lens of the fiber scope 51 or the electronic scope is located at the distal end of the compression balloon 2, and the field of view is directed toward the inside of the uterine cavity, so as to observe the condition of the uterine wall, bleeding points and the adhesion of the drug mist after the balloon is in place.

[0047] Specifically, the endoscope 51 is fixed to the main body 1 of the balloon device by embedding it into the tube. Its distal lens extends and is fixed to the farthest end of the main body 1. The flexibility of the endoscope 51 allows it to maintain structural integrity when it bends with the whole device in the uterine cavity. Based on the above settings, the observation path of the endoscope 51 and the instrument channel of the balloon device are arranged in parallel to form a composite instrument with a unified structure. This allows the operator to obtain real-time intrauterine vision and balloon compression and drug delivery functions simultaneously after a single insertion operation, thereby realizing full visual monitoring and guidance of the treatment process.

[0048] Exemplary method:

[0049] A method for assisted labor hemostasis using the above-mentioned intrauterine balloon system includes the following steps:

[0050] S1: After the fetus is delivered, the main body of the device is placed into the mother's uterine cavity;

[0051] S2: Observe and locate the main bleeding areas in the uterine cavity through the field of view of observation component 5;

[0052] S3: Fluid is injected into the compression balloon 2 through the compression tube 21 to inflate it and apply basic compression to the uterine wall to stop bleeding.

[0053] S4: With the real-time visual assistance of the observation component 5, the shape of the control balloon 3 is adjusted by the control tube 31, so that the orientation of the annular opening of the drug delivery catheter 4 is precisely aligned with the main bleeding area located in S2.

[0054] S5: Hemostatic solution is delivered to the target bleeding area through the drug delivery catheter 4. The solution is atomized and sprayed out, adhering to the uterine wall.

[0055] S6: Continuously observe the bleeding situation through observation component 5. If the bleeding is significantly reduced or stops, proceed to S7; if there is still active bleeding, repeat S4 and S5, adjust the drug delivery target area and administer supplementary drugs.

[0056] S7: After confirming that the bleeding has been effectively controlled, maintain the balloon compression for a period of time;

[0057] S8: First, empty the control balloon 3, then slowly empty the compression balloon 2, while monitoring for any recurrence of active bleeding through the observation component 5. After confirming safety, remove the main body of the device from the uterine cavity.

[0058] Specifically, firstly, after the fetus is delivered, a balloon device integrating the observation component 5 is placed into the uterine cavity. The observation component 5 provides a real-time view of the uterine cavity, allowing for direct identification of the bleeding area distribution. Subsequently, an appropriate amount of fluid is injected into the compression balloon 2 through the compression tube 21, causing it to expand and exert basic pressure on the uterine wall, controlling most of the diffuse bleeding and creating a stable environment for subsequent precise operations.

[0059] After basic compression is established, the observation component 5 is used to continuously monitor the uterine cavity status and locate persistent bleeding points or compression dead space that still exist after compression. By precisely adjusting the shape of the control balloon 3 through the control tube 31, the deformation of its specific parts drives the spatial orientation change of the annular opening of the drug delivery catheter 4, so that it is precisely aligned with the target bleeding area.

[0060] Next, the precision pump 42 connected to the drug delivery catheter 4 is activated to push the hemostatic drug solution at a constant pressure. As the drug solution flows through the shear block 41 set inside the catheter, it is broken into fine liquid particles, forming an atomized drug flow that is sprayed out from the pre-adjusted annular opening, evenly covering the target tissue surface. During this process, the drug mist adhesion and bleeding changes are monitored in real time by the observation component 5. If residual bleeding points are found, the spray angle can be readjusted immediately for supplemental drug delivery, forming a closed-loop treatment of "observation-positioning-intervention-verification".

[0061] Once bleeding is confirmed to be under effective control, maintain balloon compression for a preset time to consolidate the hemostatic effect. Finally, empty the contents of the balloon in stages, first controlling balloon 3 and then compressing balloon 2, and monitor for any signs of rebleeding throughout the process using the observation component 5. After ensuring safety, remove the device completely.

[0062] In summary, this method, by combining visual monitoring, mechanical compression, and precise drug administration, effectively intervenes in compression dead space and refractory bleeding points that are difficult to manage with traditional balloons, significantly improving the success rate of postpartum hemorrhage treatment.

[0063] Based on the preferred embodiments of the present invention described above, those skilled in the art can make various changes and modifications without departing from the inventive concept. The technical scope of this invention is not limited to the contents of the specification, but must be determined according to the scope of the claims.

Claims

1. An intrauterine balloon device for assisting childbirth, characterized in that, include: The device body includes a main body (1), a compression balloon (2) fixedly connected to the end of the main body (1), a control balloon (3) arranged parallel to the compression balloon (2) along the axial direction of the main body (1), a compression cavity tube (21) disposed in the main body (1) and communicating with the interior of the compression balloon (2) at its distal end, a control cavity tube (31) disposed in the main body (1) and communicating with the interior of the control balloon (3) at its distal end, and a drug delivery catheter (4) whose end is disposed at the maximum expandable and contractile deformable part of the control balloon (3). The drug delivery catheter (4) is disposed inside the main body (1). The distal end of the drug delivery catheter (4) extends to the outside of the control balloon (3) and is provided with an annular opening. The distal end of the drug delivery catheter (4) is provided with a plurality of integrally formed shear blocks (41). The shear blocks (41) are columnar, wing-shaped or spiral structures fixed in the internal channel of the drug delivery catheter (4). A narrow gap for the drug liquid to pass through is formed between the outer edge of the shear blocks (41) and the inner wall of the drug delivery catheter (4). When the drug liquid flows through the narrow gap under pressure, the fluid velocity increases sharply and the internal shear stress is significantly enhanced. The stress overcomes the surface tension and cohesion of the drug liquid, tears and breaks the entire flow into fine liquid particles, and sprays out from the annular opening at the distal end of the drug delivery catheter (4) to form a drug mist. The annular opening is located on the wall of the control balloon (3). When fluid is filled into the control balloon (3), the deformation of the control balloon (3) causes the spatial position and orientation of the annular opening to change, thereby adjusting the position of the drug penetration. The deformation of a specific part of the control balloon (3) can precisely change the orientation of the annular opening, so that the drug mist can be accurately aimed at the target bleeding area in the uterine cavity.

2. The intrauterine balloon device for assisting childbirth according to claim 1, characterized in that: The drug delivery catheter (4) segment with the annular opening is fixed to the balloon wall of the control balloon (3) by a biocompatible adhesive or integrally formed, so that the drug delivery catheter (4) with the annular opening moves in coordination with the deformation of the control balloon (3).

3. The intrauterine balloon device for assisting childbirth according to claim 1, characterized in that: The control balloon (3) is fixed on the main body (1) at a position relative to the compression balloon (2) towards the deeper side of the uterus, and the control balloon (3) and the compression balloon (2) are in partial contact or have a gap when inflated.

4. The intrauterine balloon device for assisting childbirth according to claim 1, characterized in that: The control balloon (3) is configured to be independently inflatable or deflated (one or more); When the number of control balloons (3) is one, the control balloon (3) is an annular balloon surrounding the main body (1). The orientation of the annular opening is adjusted by controlling the expansion or contraction of the control balloon (3) at different circumferential positions. When the number of control balloons (3) is greater than one, the control balloons (3) are arranged in a ring array around the main body (1) and the orientation of the ring opening is adjusted by selectively inflating and deflating different control balloons (3).

5. An intrauterine balloon device for assisting childbirth according to claim 1, characterized in that, It also includes an external control unit, which includes: A precision pump (42) is connected to the proximal end of a drug delivery catheter (4) for pushing drug solution; Two fluid control modules (6) are respectively connected to the inner cavities of the compression balloon (2) and the control balloon (3). The fluid control modules (6) are connected to the proximal ends of the control tube (31) and the compression tube (21) for precisely controlling the inflation and deflation of the control balloon (3) and the compression balloon (2).

6. An intrauterine balloon device for assisting childbirth according to claim 5, characterized in that: The fluid control module (6) includes an inflatable balloon that is sealed to the proximal end of the compression chamber (21) or control chamber (31), a one-way valve disposed on the connection passage between the outlet of the inflatable balloon and the compression chamber (21) or control chamber (31), and a pressure relief valve (11) mounted on the valve body of the one-way valve. The operating knob of the pressure relief valve (11) is located externally and is used to manually open it to release the fluid in the compression balloon (2).

7. An intrauterine balloon device for assisting childbirth according to claim 1, characterized in that: The control balloon (3) is made of highly elastic medical-grade silicone, and the wall thickness of the largest expandable and deformable part of the control balloon (3) is smaller than that of other parts.

8. An intrauterine balloon system for assisting childbirth, characterized in that, Includes a balloon device as described in any one of claims 1-7, and an observation component (5) for observing intrauterine conditions, the observation component (5) including a fiberscope (51), the body of the fiberscope (51) being arranged parallel to the main body (1), the distal lens portion of the fiberscope (51) or the electronic scope being located at the distal end of the compression balloon (2) and the field of view being directed toward the inside of the uterine cavity.

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