Balloon endoscopic system for intravascular direct vision examination

Abstract

The invention provides a balloon endoscopic system for intravascular direct vision examination, and relates to the technical field of medical instruments, the balloon endoscopic system comprises a catheter, a balloon capable of being filled and discharged, an endoscope lens, a light source assembly and an image transmission processing module, a cavity channel used for containing the endoscope lens and a conduction component of the light source assembly is formed in a catheter body of the catheter, and the catheter body of the catheter is internally provided with a cavity channel used for containing the endoscope lens and the conduction component of the light source assembly; the filling pipeline is used for supplying liquid to the inflatable and deflatable balloon; the inflatable and deflatable balloon is fixedly connected to the outer surface of the front end of the catheter, and the inflatable and deflatable balloon is used for bulging after being conveyed to a target position in a blood vessel. The inflatable and deflatable balloon can block blood flow and open the blood vessel wall after bulging and is matched with transparent filling liquid injected into the filling pipeline, residual blood can be further removed, a blood-free observation window is formed, interference of blood on imaging is avoided, and a foundation is laid for clearly observing the condition of the blood vessel wall. The inner wall of the balloon is coated with a nano anti-fog coating, so that the penetrability of a light source is ensured, and the fogging surface influence caused by blood residue or temperature difference can be avoided.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a balloon endoscope system for direct visualization of blood vessels. Background Technology

[0002] In the field of medical devices, vascular endoscopes are a key tool for diagnosing vascular wall lesions (such as atherosclerotic plaques and vascular stenosis), thrombosis, and other vascular diseases. Their application demand continues to grow with the rising incidence of cardiovascular diseases. In clinical practice, doctors need to use vascular endoscopes to directly observe the internal structure and pathological features of blood vessels, providing precise information for the formulation of subsequent treatment plans (such as stent implantation and thrombus removal).

[0003] However, traditional endoscopic balloons used for positioning have defects. Some balloons lack pressure monitoring and automatic adjustment functions. During inflation and deflation, the balloon is prone to rupture due to excessive pressure, or the sudden rise and fall of pressure can cause excessive expansion of the blood vessel wall and fluctuations in blood pressure, increasing the probability of complications such as vascular tearing and dissection.

[0004] To address the issues raised above, we designed a balloon endoscopy system for direct visualization of blood vessels. Summary of the Invention

[0005] The purpose of this application is to provide a balloon endoscope system for direct visualization of blood vessels.

[0006] This application provides a balloon endoscope system for direct visualization of blood vessels, which adopts the following technical solution: including a catheter, an inflatable water balloon, an endoscope lens, a light source assembly and an image transmission and processing module. The catheter has a cavity inside for accommodating the endoscope lens and the light source assembly's conductive component, as well as an inflation tube for supplying fluid to the inflatable water balloon. The inflatable balloon is fixedly connected to the outer surface of the front end of the catheter, and the inflatable balloon is used to inflate after being delivered to the target position in the blood vessel to temporarily block blood flow and expand the blood vessel wall to form a bloodless observation window. The endoscope lens is fixed inside the distal end of the catheter. The light source assembly provides illumination for the observation area of ​​the endoscope lens. The image transmission and processing module is signal-connected to the endoscope lens and is used to receive and process image information. Preferably, the central axis of the endoscope lens forms an angle of 15°-20° with the central axis of the inflatable water balloon to avoid the balloon wall obstructing the field of vision, while ensuring that the field of vision completely covers the blood vessel wall area after the balloon is inflated.

[0007] Preferably, the inflatable balloon is made of a flexible transparent polymer material with a wall thickness controlled at 0.08-0.12mm and a light transmittance of ≥92%, ensuring light source penetration and no obvious image distortion; after the inflatable balloon is deployed, its maximum diameter can be adapted to blood vessels of 2-8mm and its length is 15-25mm, meeting the coverage requirements of different blood vessel segments.

[0008] Preferably, the inner wall of the inflatable water balloon is coated with a nano anti-fogging coating to avoid the influence of fogging caused by blood residue or temperature difference. At the same time, the distal edge of the inflatable water balloon is provided with a smooth transition structure with a radius of 0.5mm to reduce frictional damage to the blood vessel wall.

[0009] Preferably, the output end of the inflation tube extends to the position of the inflatable balloon, and an inflation / deflation head is fixedly embedded at the output end of the inflation tube. The output end of the inflation / deflation head extends into the interior of the inflatable balloon, and a pressure sensor is fixedly embedded in the inner wall of the inflation / deflation head. The pressure sensor is used to monitor the internal pressure of the inflatable balloon in real time to prevent the inflatable balloon from rupturing or the blood vessels from dilating excessively. The inflation tube is used to inject transparent inflation fluid into the inflatable balloon before or during observation to further remove residual blood and improve imaging clarity.

[0010] Preferably, the endoscope lens is a fiber optic endoscope or an electronic endoscope, and the endoscope lens uses a 1 / 16-inch CMOS sensor with ≥2 million pixels, an adjustable field of view of 60°-120° to adapt to different observation range requirements, and a depth of field of 0.5-10mm to ensure clear capture of vascular wall plaque and thrombus details at close range; the outer cover of the endoscope lens is made of medical-grade sapphire material with a hardness ≥9H, scratch-resistant and light transmittance ≥98%.

[0011] Preferably, the light source component is a light-emitting diode or a laser light source, whose light is transmitted to the distal end of the catheter through an optical fiber and emitted. The LED light source uses cool white light with a color rendering index ≥90 to ensure accurate color reproduction of vascular wall lesions; the laser light source is switchable with 635nm red light assistance to enhance the contrast between the thrombus and the vascular wall. The light source component includes four medical quartz optical fibers fixed to the surface of the endoscope lens. The four medical quartz optical fibers are evenly distributed in a ring around the endoscope lens, and the four medical quartz optical fibers are at 90 degrees to each other. A microlens is fixedly provided at the end of the endoscope lens, and the medical quartz optical fibers diffuse through the microlens to ensure that the illumination area evenly covers the field of view of the endoscope lens without any blind spots.

[0012] Preferably, an operating handle is fixedly provided at the tail end of the catheter, and a data connection line is fixedly provided on the surface of the operating handle. A microcontroller is fixedly connected to the end of the data connection line away from the operating handle. The microcontroller is equipped with a light source power linkage adjustment module and an image transmission and processing module. The microcontroller can realize the linkage of inflatable water balloon inflation, light source power adjustment and image processing. The parameters are automatically adjusted by the microcontroller, eliminating the need for manual operation by the doctor and reducing the complexity of operation.

[0013] Preferably, the surface of the operating handle is rotatably provided with a pull-wire knob, one end of which extends into the interior of the operating handle and is fixedly connected to a rotating disk. The surface of the pull-wire knob is provided with a torsion spring. The surface of the rotating disk is symmetrically and fixedly provided with two limiting rings. The surface of the limiting rings is fixedly connected with adjusting pull wires. The ends of the two adjusting pull wires away from the rotating disk extend to the position of the endoscope lens, and the two adjusting pull wires are respectively fixedly connected to the two sides of the endoscope lens. The bottom of the operating handle is fixedly provided with a multi-functional handle, and the surface of the multi-functional handle integrates a balloon inflation / deflation knob, a light source mode switching key, and an image freeze key.

[0014] Preferably, the catheter contains an internal flushing tube, the inlet of which extends to the outside of the catheter. A flushing head is fixedly mounted at the front end of the catheter, and the surface of the flushing head has several flushing holes. The outlet of the flushing tube extends into the interior of the flushing head, and the end of the flushing tube furthest from the flushing head extends to the tail of the operating handle. A hemostatic valve is provided at the outlet of the flushing tube. A movable baffle is located inside the flushing head, its position corresponding to the outlet of the flushing tube. Two movable rods are fixedly connected to the surface of the movable baffle, one end of each rod extending into the interior of the catheter. A pressure tube is fixedly embedded at the end of the conduit. The output end of the pressure tube extends into the interior of the flushing head, and a spring-loaded switch valve is fixedly connected to the input end of the pressure tube. An inlet pipe is fixedly connected to the input end of the spring-loaded switch valve, and the input end of the inlet pipe extends into the interior of the inflatable water balloon. A trigger push plate is fixedly connected to the spring switch end of the spring-loaded switch valve. A push rod is fixedly connected to the surface of the trigger push plate. The end of the push rod away from the trigger push plate is fixedly connected to the end of a movable rod. A return spring is sleeved on the surface of the movable rod, and one end of the return spring is fixedly connected to the inner wall of the flushing head.

[0015] In summary, this application includes at least one of the following beneficial technical effects: 1. The inflatable balloon, once inflated, blocks blood flow and expands the vessel wall. Combined with the transparent filling fluid injected through the filling tube, it further removes residual blood, creating a bloodless observation window and preventing blood from interfering with imaging, thus laying the foundation for clear observation of the vessel wall. The inner wall of the balloon is coated with a nano-anti-fog coating, ensuring light penetration while avoiding fogging caused by blood residue or temperature differences, resulting in no significant image distortion. A pressure sensor inside the inflation / deflation head monitors the internal pressure of the balloon in real time, preventing balloon rupture or excessive vessel dilation. The distal edge of the balloon features a smooth transition structure with a 0.5mm radius, reducing frictional damage to the vessel wall. The flushing tube, along with the flushing head and hemostatic valve, flushes impurities from within the vessel during the examination and prevents blood leakage, ensuring examination safety. 2. By setting up the light source components, the LED light source is cool white light with a color rendering index ≥90, which can truly restore the color of lesions on the blood vessel wall; the 635nm red laser light source can be switched, which can enhance the contrast between the thrombus and the blood vessel wall; four medical quartz optical fibers are evenly distributed in a ring around the endoscope lens, and the light is diffused through microlenses to ensure that the illumination area evenly covers the field of view without any blind spots.

[0016] 3. Automated linkage control: The microcontroller enables coordinated inflation of the inflatable balloon, adjustment of the light source power, and image processing, eliminating the need for manual operation by the doctor and reducing operational complexity. When the balloon pressure reaches 0.5 atm during initial inflation, the system automatically activates the light source (initial power 10mW) and puts the image processing system into pre-noise reduction mode. When the balloon is fully inflated, the light source power automatically adjusts according to the blood vessel diameter: 20mW for a diameter <3mm and 25mW for a diameter ≥3mm. The image processing system also switches to enhancement mode, enabling automatic lesion marking. During balloon deflation, the system first reduces the light source power to 5mW and then slowly deflates the balloon to avoid sudden increases in blood pressure that could damage the blood vessels. Attached Figure Description

[0017] Figure 1 This is a three-dimensional first-person perspective structural diagram of this application; Figure 2 This is a schematic diagram of the three-dimensional second-view structure of this application; Figure 3 yes Figure 2 Enlarged structural diagram at point A; Figure 4 This is a schematic diagram of the three-dimensional third-view structure of this application; Figure 5 yes Figure 4 Enlarged structural diagram at point B; Figure 6 This is a partial cross-sectional view of the inflatable balloon and catheter. Figure 7 yes Figure 6 Enlarged structural diagram at point C; Figure 8 This is a schematic diagram of the working state of this application inside a blood vessel; Figure 9 This is a schematic diagram of a partial orthogonal section of the catheter structure of this application.

[0018] Explanation of reference numerals in the attached diagram: 1. Catheter; 2. Inflatable water-filled balloon; 3. Endoscope lens; 4. Light source assembly; 5. Inflation tube; 6. Operating handle; 7. Data connection cable; 8. Microcontroller; 9. Multifunctional handle; 10. Irrigation tube; 11. Irrigation head; 12. Irrigation port; 13. Hemostatic valve; 14. Movable baffle; 15. Movable rod; 16. Pressure tube; 17. Spring-loaded switch valve; 18. Inlet tube; 19. Trigger plate; 20. Push rod; 21. Return spring; 1. Quartz optical fiber; 402 microlens; 501. Inflation / Relief Head; 502. Pressure Sensor; 601. Pull-cord knob; 602. Rotary disc; 603. Limit ring; 604. Adjusting pull cord; 605. Torsion spring. Detailed Implementation

[0019] The following is in conjunction with the appendix Figure 1 -Appendix Figure 9 This application will be described in further detail below.

[0020] A balloon endoscope system for direct visualization of blood vessels, the core structure of which includes a catheter 1, an inflatable water balloon 2, an endoscope lens 3, and a light source assembly 4.

[0021] Reference Figures 1 to 3 The inflatable water-filled balloon 2 is fixedly connected to the outer surface of the front end of the catheter 1, and the two are coaxially arranged to ensure that the balloon can symmetrically expand the blood vessel wall along the axis of the catheter 1 when it inflates. The inflatable water-filled balloon 2 is made of flexible transparent polymer material (such as medical polyamide-polyether block copolymer), with a wall thickness strictly controlled at 0.08-0.12mm and a light transmittance ≥92%, which can ensure efficient light transmission of the light source component 4 and avoid significant image distortion. Its maximum diameter after expansion can be adapted to blood vessels of 2-8mm, and its length is 15-25mm, which can meet the examination coverage needs of different blood vessel segments such as coronary arteries and cerebral blood vessels. At the same time, the inner wall of the inflatable water-filled balloon 2 is coated with a nano anti-fog coating (such as silica nanofilm), which can effectively avoid the influence of fogging caused by blood residue or temperature difference, and ensure image clarity. Its distal edge has a smooth transition structure with a radius of 0.5mm, which can reduce friction damage to the blood vessel wall during the delivery of the catheter 1 and improve the safety of the examination.

[0022] Reference Figures 3 to 5The catheter 1 has multiple independent cavities inside its body. One cavity is used to accommodate the transmission components (such as optical fibers) of the endoscope lens 3 and the light source assembly 4. Another cavity has a built-in filling tube 5, and another cavity is used to place the flushing tube 10. The multi-cavity separation design can avoid mutual interference between the components when they are working.

[0023] The endoscope lens 3 is fixed inside the distal end of the catheter 1, and the central axis of the endoscope lens 3 forms an angle of 15°-20° with the central axis of the inflatable water balloon 2. This angle design effectively avoids the balloon wall of the inflatable water balloon 2 from obstructing the field of view, while ensuring that the lens field of view completely covers the blood vessel wall area after the balloon is inflated, achieving observation without blind spots. The endoscope lens 3 can be either a fiber optic endoscope or an electronic endoscope, which uses a 1 / 16-inch CMOS sensor with ≥2 million pixels and an adjustable field of view of 60°-120° to adapt to different observation ranges according to examination needs; the depth of field is 0.5-10mm, which can clearly capture the detailed features of blood vessel wall plaques and thrombi at close range; the lens cover is made of medical-grade sapphire material with a hardness ≥9H, which not only prevents scratches (preventing the catheter 1 from being scratched by impurities in the blood vessel during delivery), but also has a light transmittance of ≥98%, further ensuring image quality.

[0024] Reference Figures 4 to 7 The core components of the light source assembly 4 include four medical quartz optical fibers 401 and a microlens 402. The four medical quartz optical fibers 401 are fixed on the surface of the endoscope lens 3 and are evenly distributed in a ring around the endoscope lens 3. The included angle between two adjacent medical quartz optical fibers 401 is 90°. The microlens 402 is fixedly installed at the end of the endoscope lens 3 and is coaxial with the endoscope lens 3. The light-emitting end of the medical quartz optical fiber 401 faces the microlens 402. The light source component 4 can be either a light-emitting diode (LED) or a laser light source. The light is transmitted to the distal end of the catheter 1 through a medical quartz optical fiber 401, and then diffused by a microlens 402 to uniformly illuminate the observation area, ensuring that there are no blind spots in the illumination. If an LED light source is selected, it is cool white light (color temperature 5000-6500K) with a color rendering index ≥90, which can truly reproduce the color of vascular wall lesions (such as the yellow of atherosclerotic plaques and the red of thrombi), making it easier for doctors to accurately determine the type of lesion. If a laser light source is selected, a 635nm red light mode can be switched. This wavelength of light can enhance the contrast between thrombi and the vascular wall, making it easier to identify tiny thrombi.

[0025] Reference Figures 5 to 8The inlet end of the inflation conduit 5 extends to the tail end of the catheter 1 and connects to the inflation / deflation control structure within the operating handle 6. The outlet end extends to the position of the inflatable / deflation balloon 2, and an inflation / deflation head 501 is fixedly embedded in the outlet end of the inflation conduit 5. The outlet end of the inflation / deflation head 501 extends directly into the interior of the inflatable / deflation balloon 2 for injecting or deflation of the inflation medium (liquid or transparent liquid) into the balloon. A pressure sensor 502 is fixedly embedded in the inner wall of the inflation / deflation head 501. The pressure sensor 502 is connected to the microcontroller 8 and can monitor the pressure inside the inflatable / deflation balloon 2 in real time. When the pressure exceeds the safety threshold (such as 2.5 atm to prevent excessive vasodilation) or is lower than the pressure for effective blood flow occlusion (such as 0.4 atm), the microcontroller 8 will issue an early warning and automatically adjust to avoid rupture of the inflatable / deflation balloon 2 or incomplete blood flow occlusion affecting observation. In addition, the filling tube 5 can inject transparent filling fluid (such as physiological saline) into the inflatable balloon 2 before or during observation to further remove residual blood between the balloon and the blood vessel wall, forming a bloodless observation window and improving imaging clarity.

[0026] Reference Figures 7 to 8 The inlet end of the flushing tube 10 extends to the outside of the catheter 1, and the outlet end extends to the inside of the flushing head 11 at the front end of the catheter 1. The flushing head 11 is fixedly installed at the front end of the catheter 1, located on the proximal side of the inflatable balloon 2 (closer to the operating handle 6). Several evenly distributed flushing holes 12 are opened on the surface of the flushing head 11, facing the gap between the inflatable balloon 2 and the blood vessel wall. The end of the flushing tube 10 away from the flushing head 11 extends to the tail of the operating handle 6, and a hemostatic valve 13 is provided at the port. The hemostatic valve 13 can prevent blood from leaking from the port of the flushing tube 10 during flushing, and at the same time facilitates the doctor to control the injection rate and dosage of the flushing solution. During the examination, saline is delivered to the flushing head 11 through the flushing tube 10, and the flushing solution is sprayed out through the flushing holes 12, which can remove impurities or residual blood on the surface of the blood vessel wall, further optimizing the observation environment.

[0027] Reference Figure 9The flushing head 11 is equipped with a movable baffle 14, which is positioned corresponding to the outlet of the flushing pipe 10. Two movable rods 15 are fixedly connected to the surface of the movable baffle 14. One end of each movable rod 15 extends into the interior of the conduit 1. A pressure tube 16 is fixedly embedded at the end of the conduit 1. The output end of the pressure tube 16 extends into the interior of the flushing head 11. A spring-loaded switch valve 17 is fixedly connected to the input end of the pressure tube 16. An inlet pipe 18 is fixedly connected to the input end of the spring-loaded switch valve 17. The input end of the inlet pipe 18 extends into the interior of the inflatable balloon 2. A trigger push plate 19 is fixedly connected to the spring switch end of the spring-loaded switch valve 17. A push rod 20 is fixedly connected to the surface of the trigger push plate 19. The end of the push rod 20 away from the trigger push plate 19 is fixedly connected to the end of the movable rod 15. A return spring 21 is sleeved on the surface of the movable rod 15. One end of the return spring 21 is fixedly connected to the inner wall of the flushing head 11.

[0028] By setting up a series of automatic pressurization structures such as the movable baffle 14 and the spring-type switch valve 17, when the flushing hole 12 on the surface of the flushing head 11 becomes blocked and the blockage enters the interior of the flushing head 11, the movable baffle 14 will drive the movable rod 15 to move into the conduit 1 after being pressurized. Then, the movable rod 15 drives the push rod 20 to move and trigger the push plate 19. The push plate 19 triggers the spring switch of the spring-type switch valve 17, and then the liquid in the inflatable and deflated water balloon 2 is input into the pressurization pipe 16 through the liquid inlet pipe 18. Then, the liquid is input into the interior of the flushing head 11 through the pressurization pipe 16. Thus, with the assistance of the liquid, the debris accumulated inside the flushing head 11 is flushed out of the flushing hole 12, achieving the purpose of automatic anti-clogging and cleaning of the flushing head 11.

[0029] Reference Figures 1 to 3The tail end of catheter 1 is fixedly connected to operating handle 6, which is the core component for the doctor's hand operation. A pull-wire knob 601 is rotatably mounted on its surface. One end of the pull-wire knob 601 extends into the interior of operating handle 6 and is fixedly connected to rotating disk 602. A torsion spring 605 is fitted onto the surface of pull-wire knob 601. One end of the torsion spring 605 is fixed to the inner wall of operating handle 6, and the other end is fixed to pull-wire knob 601, for automatic reset after rotation. Two limiting rings 603 are symmetrically fixedly mounted on the surface of rotating disk 602. The two limiting rings 603 are located on both sides of rotating disk 602 and are coaxial with rotating disk 602. An adjusting pull wire 604 is fixedly connected to the surface of each limiting ring 603. The ends of both adjusting pull wires 604 away from rotating disk 602 pass through the cavity inside catheter 1, extending to the position of endoscope lens 3, and are fixedly connected to both sides of endoscope lens 3. When the doctor turns the pull cable knob 601, the pull cable 604 can be tightened or loosened by rotating the disc 602, thereby fine-tuning the angle of the endoscope lens 3 to adapt to the observation needs of different blood vessel directions. The reset function of the torsion spring 605 can simplify the operation steps and improve the convenience of operation.

[0030] Reference Figures 3 to 4 The bottom of the operating handle 6 is fixedly equipped with a multi-functional handle 9, which is convenient for doctors to hold and operate with one hand. The surface of the multi-functional handle 9 integrates a balloon inflation / deflation knob, a light source mode switching key, and an image freeze key. The balloon inflation / deflation knob is connected to the inflation tube 5 and is used to manually assist in controlling the inflation and deflation of the water-filled balloon 2. The light source mode switching key can directly switch between LED cold white light and 635nm red light modes. The image freeze key can quickly freeze the currently observed image, making it convenient for doctors to record lesion details. The integrated design reduces the range of hand movement during operation and improves examination efficiency.

[0031] Reference Figures 1 to 3 A data connection cable 7 is fixedly mounted on the surface of the operating handle 6. The end of the data connection cable 7 furthest from the operating handle 6 is fixedly connected to the microcontroller 8, which is used to realize signal transmission and power supply between the operating handle 6, the endoscope lens 3, the light source assembly 4, and the pressure sensor 502. The microcontroller 8 integrates an image transmission processing module and a light source power linkage adjustment module. The image transmission processing module is connected to the endoscope lens 3 and can receive image information acquired by the lens in real time and perform noise reduction, enhancement, and other processing. The light source power linkage adjustment module is connected to the light source assembly 4 and can automatically adjust the light source power according to the inflation state of the inflatable water balloon 2.

[0032] Working principle: The doctor holds the operating handle 6 and the multi-functional handle 9, and slowly delivers the tip of the catheter 1 to the target examination location in the blood vessel (such as a segment of the blood vessel suspected of having plaque). The doctor starts the inflation procedure by using the balloon inflation / deflation knob on the multi-functional handle 9. The inflation medium is injected into the inflatable / deflationable balloon 2 through the inflation tube 5 and the inflation / deflation head 501. The inflatable / deflationable balloon 2 gradually inflates and expands the blood vessel wall, while temporarily blocking blood flow to the target area. At this time, the pressure sensor 502 inside the inflation / deflation head 501 transmits the balloon pressure data to the microcontroller 8 in real time. When the pressure reaches 0.5 atm (initial occlusion pressure), the microcontroller 8 automatically activates the light source component 4, and the image transmission and processing module enters the pre-noise reduction mode to filter image noise caused by residual blood flow. When the pressure rises to 1.5-2.0 atm, the inflatable / deflation balloon 2 is fully inflated, forming a stable bloodless observation window. The microcontroller 8 automatically adjusts the light source power according to the blood vessel diameter, and the image transmission and processing module switches to the enhancement mode, activates the lesion marking function (such as automatically identifying plaque edges and thrombus locations), and displays the processed clear image on the external display screen in real time. During the examination, the doctor can fine-tune the angle of the endoscope lens 3 by turning the pull-wire knob 601 on the operating handle 6. If any impurities are found in the local area, the hemostasis valve 13 can be opened, and saline solution can be injected into the irrigation head 11 through the irrigation tube 10. The irrigation solution is sprayed out through the irrigation hole 12. After removing the impurities, the hemostasis valve 13 can be closed. Finally, the water balloon 2 can be inflated and deflated slowly at a rate of 0.2 atm / s. The entire examination process is completed after the balloon is fully contracted.

Claims

1. A balloon endoscopy system for intravascular direct vision, comprising a catheter (1), a water-filled balloon (2), an endoscope lens (3), a light source assembly (4) and an image transmission and processing module, characterized in that, The tube body of the catheter (1) is internally provided with a cavity for accommodating the endoscope lens (3) and the light source assembly (4) conducting components, and a filling pipeline (5) for supplying liquid to the inflatable water balloon (2); The inflatable water balloon (2) is fixedly connected to the outer surface of the front end of the catheter (1), and the inflatable water balloon (2) is used to swell after being delivered to the target position in the blood vessel to temporarily block the blood flow and expand the blood vessel wall to form a blood-free observation window; The endoscope lens (3) is fixed to the inner part of the distal end of the catheter (1), the light source assembly (4) is used to provide illumination for the observation area of the endoscope lens (3), and the image transmission processing module is signal connected with the endoscope lens (3) for receiving and processing image information; According to the balloon endoscopy system for intravascular direct vision inspection of claim 1, the lens center axis of the endoscope lens (3) and the center axis of the inflatable water balloon (2) form an angle of 15°-20°, which avoids the obstruction of the balloon wall to the field of view and ensures that the field of view completely covers the blood vessel wall area after the balloon is expanded.

2. The balloon endoscopy system for intravascular direct vision inspection according to claim 2, characterized by, The inflatable water balloon (2) is made of flexible transparent high polymer material with a wall thickness controlled within 0.08-0.12mm and a light transmittance of ≥92%, which ensures the light transmittance and no obvious image distortion; the maximum diameter of the inflatable water balloon (2) after expansion can be adapted to 2-8mm blood vessels, and the length is 15-25mm, which meets the coverage requirements of different blood vessel segments.

3. A balloon endoscope system for direct visualization of blood vessels according to claim 3, characterized in that, The inner wall of the inflatable water balloon (2) is coated with a nano anti-fog coating to avoid the influence of fog caused by blood residue or temperature difference, and the distal edge of the inflatable water balloon (2) is provided with a smooth transition structure with a radius of 0.5mm to reduce the friction damage to the blood vessel wall.

4. A balloon endoscope system for direct visualization of blood vessels according to claim 4, characterized in that, The output end of the filling pipeline (5) extends to the position of the inflatable water balloon (2), and the output end of the filling pipeline (5) is fixedly embedded with a filling and discharging head (501), the output end of the filling and discharging head (501) extends to the inside of the inflatable water balloon (2), the inner wall of the filling and discharging head (501) is fixedly embedded with a pressure sensor (502), the pressure sensor (502) is used to monitor the internal pressure of the inflatable water balloon (2) in real time to prevent the inflatable water balloon (2) from being broken or the blood vessel from being excessively expanded, and the filling pipeline (5) is used to inject transparent filling liquid into the inflatable water balloon (2) before or during observation to further exclude residual blood and improve the imaging clarity.

5. A balloon endoscope system for direct visualization of blood vessels according to claim 5, characterized in that, The endoscope lens (3) is a fiber optic endoscope or an electronic endoscope, and the endoscope lens (3) adopts a 1 / 16 inch CMOS sensor with a pixel of ≥2 million, a field of view angle of 60°-120° adjustable, an adaptation to different observation range requirements, a depth of field of 0.5-10mm, and an assurance of clearly capturing the details of blood vessel wall plaques and thrombi at close range; the outer cover of the endoscope lens (3) is made of medical sapphire material with a hardness of ≥9H, which is scratch-resistant and has a light transmittance of ≥98%.

6. A balloon endoscopy system for direct visualization of blood vessels according to claim 6, characterized in that, The light source assembly (4) is a light-emitting diode or a laser light source, and the light rays are conducted to the distal end of the catheter (1) through optical fibers. The LED light source adopts cold white light (color temperature 5000-6500K), and the color rendering index is greater than or equal to 90, which ensures the true color restoration of the blood vessel wall lesions. The laser light source is 635nm red light auxiliary switchable, which is used to enhance the contrast between thrombus and blood vessel wall. The light source assembly (4) includes four medical quartz optical fibers (401) fixed on the surface of the endoscope lens (3). The four medical quartz optical fibers (401) are evenly distributed around the endoscope lens (3) in a ring shape, and the four medical quartz optical fibers (401) are 90 degrees apart from each other. The end of the endoscope lens (3) is fixedly provided with a microlens (402), and the medical quartz optical fibers (401) are diffused through the microlens (402), which ensures that the illumination area uniformly covers the field of view of the endoscope lens (3) without dark corners.

7. A balloon endoscope system for direct visualization of blood vessels according to claim 7, characterized in that, The tail of the catheter (1) is fixedly provided with an operation handle (6), and the surface of the operation handle (6) is fixedly provided with a data connection line (7). One end of the data connection line (7) away from the operation handle (6) is fixedly connected with a microcontroller (8). The microcontroller (8) is internally provided with a light source power linkage adjustment module, and an image transmission processing module is arranged in the microcontroller (8). The microcontroller (8) can realize the linkage of the inflatable water balloon (2), light source power adjustment and image processing. The parameters are automatically adjusted by the microcontroller (8), without the need for manual operation by the doctor, thereby reducing the operation complexity.

8. The balloon endoscopy system of claim 8, wherein, The surface of the operation handle (6) is rotatably provided with a pull wire knob (601), one end of the pull wire knob (601) extends into the interior of the operation handle (6), and a rotating disc (602) is fixedly connected. The surface of the pull wire knob (601) is provided with a torsional spring (605), and the surface of the rotating disc (602) is fixedly provided with two limiting rings (603) symmetrically. The surface of the limiting ring (603) is fixedly connected with an adjusting pull wire (604), and one end of the two adjusting pull wires (604) away from the rotating disc (602) extends to the position of the endoscope lens (3), and the two adjusting pull wires (604) are fixedly connected with the two sides of the endoscope lens (3), respectively. The bottom of the operation handle (6) is fixedly provided with a multifunctional handle (9), and the surface of the multifunctional handle (9) is integrated with a balloon inflation and discharge knob, a light source mode switching key and an image freezing key.

9. A balloon endoscope system for direct visualization of blood vessels according to claim 9, characterized in that, The inside of the catheter (1) is provided with a flushing pipe (10), the input end of the flushing pipe (10) extends to the outside of the catheter (1), the front end of the catheter (1) is fixedly provided with a flushing head (11), the surface of the flushing head (11) is provided with a plurality of flushing holes (12), the output end of the flushing pipe (10) extends to the inside of the flushing head (11), the end of the flushing pipe (10) away from the flushing head (11) extends to the tail of the operating handle (6), and the output port of the flushing pipe (10) is provided with a hemostasis valve (13), the inside of the flushing head (11) is provided with a movable baffle (14), the position of the movable baffle (14) corresponds to the outlet of the flushing pipe (10), and the surface of the movable baffle (14) is fixedly connected with two movable rods (15), one end of the two movable rods (15) extends to the inside of the catheter (1), the end of the catheter (1) is fixedly embedded with a pressurizing pipe (16), the output end of the pressurizing pipe (16) extends to the inside of the flushing head (11), and the input end of the pressurizing pipe (16) is fixedly connected with a spring type on-off valve (17), the input end of the spring type on-off valve (17) is fixedly connected with a liquid inlet pipe (18), the input end of the liquid inlet pipe (18) extends to the inside of the inflatable water balloon (2), the spring switch end of the spring type on-off valve (17) is fixedly connected with a trigger push plate (19), the surface of the trigger push plate (19) is fixedly connected with a push rod (20), one end of the push rod (20) away from the trigger push plate (19) is fixedly connected with the end of the movable rod (15), the surface of the movable rod (15) is sleeved with a reset spring (21), one end of the reset spring (21) is fixedly connected with the inner wall of the flushing head (11).

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