Blocking sheath tube device for bleeding in robot bronchoscope operation and bronchoscope system

Abstract

The invention discloses a blocking sheathing canal device for bleeding in a robot bronchoscope operation and a bronchoscope system, and belongs to the technical field of medical instruments. The blocking sheathing canal device comprises a guide pipeline, a blocking balloon, a medium channel and a pressure device; a pipe cavity is formed in the guide pipeline, and the robot bronchoscope enters a focus position through the pipe cavity; the blocking balloon is arranged at the far end of the guiding pipeline, can expand and deform in the radial direction of the guiding pipeline in the pressure state and is used for blocking the bronchus or / and the lumen; the medium channel is arranged on the guide pipeline, the pressure device is communicated with the near end of the medium channel, and a pressure medium is injected into the plugging balloon through the medium channel; under the bleeding condition, the balloon can be rapidly inflated through the pressure device at the near end of the guide pipeline, so that the balloon is expanded and deformed to completely block the gap between the guide pipeline and the bronchus, the emergency bleeding in the robot bronchoscope operation is blocked, and the safety of the robot bronchoscope operation is improved; and popularization and application of the robot bronchoscope operation are promoted.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a sheath device for blocking bleeding during robot bronchoscopy and a bronchoscope system. Background Art

[0002] With the increase in the detection rate of peripheral pulmonary nodules, how to obtain specimens of peripheral pulmonary nodules more safely and effectively and then make a clear diagnosis has become an important issue facing clinical practice. In recent years, virtual navigation, electromagnetic navigation, RP-EBUS and other guided bronchoscopic technologies have continued to develop, and the diagnosis rate of peripheral pulmonary nodules through bronchoscopy has been significantly improved. However, the overall diagnosis rate of peripheral pulmonary nodules through bronchoscopy is still not ideal, far lower than that of percutaneous lung puncture technology. However, compared with percutaneous lung puncture technology, bronchoscopy is operated through the natural cavity, which reduces complications such as pneumothorax and bleeding, reduces the risk of implantation and metastasis, and combined with EBUS-TBNA (transbronchial needle aspiration biopsy under ultrasound bronchoscope guidance), it can be diagnosed and staged in one operation at the same time, which has irreplaceable advantages. Therefore, it is necessary to further improve the positive rate of diagnosis of peripheral pulmonary nodules through bronchoscopy.

[0003] Compared with traditional thin bronchoscopes, the diameter of the robot-assisted bronchoscopy system (RAB) can be made thinner, and it can enter more distal airways. At the same time, it is not affected by the operator's wrist angle and muscle fatigue, so it has better stability and flexibility, especially in bronchi with complex angles. Because the robot bronchoscope system has better visibility, stability and flexibility, it has irreplaceable advantages in the diagnosis and treatment of peripheral lesions, and therefore is of great significance to further improve the diagnosis rate of peripheral pulmonary lesions.

[0004] However, there are still many problems in the application of robotic bronchoscopy technology at this stage. Among them, the safety issue is the most concerned by clinicians. At present, the emergency response capability of the robotic bronchoscopy system, especially the ability to deal with emergency bleeding during surgery, is still the most worrying issue for clinicians. Compared with traditional bronchoscopes, the main advantage of robotic bronchoscopes is that they use computer system fine control instead of fatigued human hands to achieve more accurate navigation and biopsy sampling. However, as an operating system remotely controlled by an operating handle, the operator cannot feel the touch like when operating the scope by hand, and the lack of tactile feedback will increase the potential risk during operation. Although the high-definition magnified field of view can make up for the defect of lack of tactile feedback to a certain extent, this compensation cannot actually completely avoid similar risks. If the doctor is not skilled in operation, or in some special cases, such as needing to bypass curved or nearly right-angled distal bronchial branches, the scope will inevitably come into contact and collide with the airway. In these scenarios, it is very dangerous to push the scope without tactile feedback, which may cause serious airway injury or even massive bleeding in the airway. In addition to airway injury and bleeding caused by collision, sudden bleeding of the lesion itself during biopsy or treatment is a greater concern for clinicians and one of the most important obstacles to the clinical use of robotic bronchoscope systems. Because for some high-risk cases, once massive bleeding occurs after biopsy or treatment, it will have fatal consequences if there is no effective response.

[0005] At present, it is recommended to prepare preventive strategies in advance before performing clinical operations of robotic bronchoscopes. There are two preventive strategies. The first preventive strategy is that when bleeding occurs during robotic bronchoscopy, do not withdraw the scope, but embed the flexible scope in the distal bronchial opening for packing and hemostasis. At the same time, a 4mm thin bronchoscope can be inserted orally or nasally to assist in hemostasis. The second preventive strategy is to quickly withdraw the robotic bronchoscope and switch to other interventional treatments. However, in real clinical scenarios, the implementation of these plans faces some difficulties. For example, when there is a lot of bleeding in the airway, the hemostasis effect of the scope embedding is not ideal, and in the absence of tactile feedback, the loss of vision may make the operator more panicked; withdrawing the robotic bronchoscope and switching to other interventional treatments will delay time and even miss the opportunity for rescue (the scope may not be able to enter the airway again when there is heavy bleeding). Therefore, if the robotic bronchoscope system itself can be improved to improve its ability to deal with emergency bleeding during surgery, it will be a better choice both from the perspective of surgical convenience and health economics. Summary of the invention

[0006] In response to the problems existing in the prior art, the present invention provides a sheath device and a bronchoscope system for blocking bleeding during robotic bronchoscopy, which can block emergency bleeding during bronchoscopy, improve the safety of robotic bronchoscopy, and promote the promotion and application of robotic bronchoscopy.

[0007] The present invention is achieved through the following technical solutions: A sheath device for blocking bleeding during robotic bronchoscopy, comprising a guide tube, a blocking balloon, a medium channel and a pressure device; The guide tube has a lumen formed inside thereof, and the lumen can allow a bronchoscope to pass through and enter the lesion location; The blocking balloon is arranged at the distal end of the guide tube, and can expand and deform along the radial direction of the guide tube under pressure to block the bronchus and / or the lumen; The medium channel is arranged on the guide pipe and arranged along the axial direction of the guide pipe, one end of the medium channel is connected to the blocking balloon, and the other end extends to the proximal end of the guide pipe; The pressure device is communicated with the proximal end of the medium channel and is used to inject pressure medium into the blocking balloon through the medium channel.

[0008] Preferably, the blocking balloon comprises a blocking ring or an elastic blocking film; A medium cavity is formed inside the blocking ring, the blocking ring is sleeved and fixed on the outer wall of the distal end of the guide pipe, and a medium hole is provided on the blocking ring and communicated with the distal end of the medium channel; The elastic blocking film surrounds the outer wall of the distal end of the guide pipe, and two sides of the elastic blocking film are fixedly connected to the outer wall of the guide pipe.

[0009] Preferably, the ring wall of the blocking ring is a film; The blocking ring is attached to the outer wall of the far end of the guide pipe when no pressure medium is injected.

[0010] Preferably, the blocking balloon is provided with a plurality of pressure chambers, the plurality of pressure chambers are arranged in a ring shape, and each pressure chamber is connected to a medium channel.

[0011] Preferably, a constraint structure is provided on the outer surface of the blocking balloon to constrain the maximum deformation state of the blocking balloon; The restraining structure is an elastic restraining net, which covers the surface of the blocking balloon.

[0012] Preferably, a fiber Bragg grating sensor is embedded on the surface of the blocking balloon to detect the pressure between the blocking balloon and the bronchus.

[0013] Preferably, a blocking device is provided at the distal end of the lumen of the guide tube for blocking the gap between the lumen or the inner wall of the guide tube and the bronchoscope.

[0014] Preferably, the blocking device is an inner balloon or an elastic blocking body; The inner balloon is an elastic blocking film, and two sides of the elastic blocking film are fixedly connected to the inner wall of the guide tube; The elastic blocking body is an annular structure, the thickness of the elastic blocking body decreases from the inner wall of the guide pipe to the center, and a hole is arranged in the center of the elastic blocking body; When the bronchoscope is not inserted, the channel is in a closed state due to the elastic force of the elastic occluding body.

[0015] Preferably, the medium channel is arranged in the pipe wall of the guide pipe; Alternatively, the medium channel is arranged in a medium pipeline, and the medium pipeline is arranged on a pipe wall of the guide pipe.

[0016] A robotic bronchoscope system comprises a sheath device for blocking bleeding during robotic bronchoscope surgery.

[0017] Compared with the prior art, the present invention has the following beneficial technical effects: The present application provides a sheath device for blocking bleeding during robot bronchoscopy, wherein the blocking balloon is arranged on the outer wall of the distal end of the guide tube, and can expand and deform along the circumference of the guide tube under pressure to effectively block the bronchus or lumen. When dealing with intraoperative bleeding, the blocking can be implemented quickly and accurately, thereby significantly improving the safety and success rate of the operation. Secondly, the medium channel is arranged along the axial direction of the guide tube, which provides a direct and efficient path for the transmission of the pressure medium, making the injection of the pressure medium more convenient and rapid, and improving the response speed of the blocking operation. In addition, the pressure device is connected to the proximal end of the medium channel, and the injection pressure is controlled by the pressure device to accurately control the expansion of the blocking balloon, which can ensure effective blocking and avoid excessive compression to cause damage to the surrounding tissues, thereby improving the precision and safety of the operation; finally, the lumen of the guide tube serves as the guide channel of the bronchoscope, which can ensure that the bronchoscope is accurately and quickly inserted and guided to the target position, improves the convenience and accuracy of the surgical operation, and enables the doctor to perform subsequent treatment operations more quickly. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without creative work.

[0019] Figure 1 This is a schematic diagram of the appearance of the occluding sheath device of the present invention; Figure 2 It is an axial cross-sectional view of the blocking sheath device of the present invention; Figure 3 A cross-sectional view of the position of the outer balloon of the occluding sheath device of the present invention; Figure 4 is a cross-sectional view of an inner balloon of the occluding sheath device of the present invention, in which the inner balloon includes two sub-balloons; Figure 5 It is a schematic plan view of the unfolded state of the elastic restraint net on the outer balloon of the present invention; Figure 6 This is a state diagram of a bronchoscope being inserted into an elastic occluding body according to an embodiment of the present invention; Figure 7 An axial cross-sectional view of an elastic sealing body according to an embodiment of the present invention; Figure 8 This is a schematic diagram of the structure in which the medium channel is arranged on the outer wall of the guide pipeline in Example 2 of the present invention; Fig. 9 A schematic diagram of bronchial occlusion by the occluding sheath device of the present invention; Fig.10 This is a state diagram of the external balloon of the present invention blocking the bronchus.

[0020] In the figure: 1. guide tube; 2. medium channel; 3. lumen; 4. inner balloon; 5. outer balloon; 6. pressure chamber; 7. air inlet; 8. separation membrane; 9. daughter balloon; 10. elastic constraint net; 11. elastic blocking body; 12. channel; 100. bronchus; 200. bronchoscope. DETAILED DESCRIPTION

[0021] In order to make the purpose, technical solution and advantages of the embodiments of the present application clearer, the technical solution in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all the embodiments. The components of the embodiments of the present application described and shown in the drawings here can be arranged and designed in various different configurations.

[0022] Therefore, the following detailed description of the embodiments of the present application provided in the accompanying drawings is not intended to limit the scope of the present application for which protection is sought, but merely represents selected embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in the field without creative work are within the scope of protection of the present application.

[0023] Emergency bleeding occurs during robotic bronchoscopy. Since the robotic bronchoscope lacks tactile feedback, the operator lacks timely perception of complications such as damage and bleeding during the operation, which may lead to serious complications that endanger the patient's life. In view of the problem that the existing robotic bronchoscope cannot deal with emergency bleeding, the present application provides a sheath device for blocking bleeding during robotic bronchoscopy, which can make up for the defects of the robotic bronchoscope system in dealing with emergency bleeding in the diagnosis and treatment of peripheral pulmonary nodules, improve the safety of robotic bronchoscopy, and promote the development and application of robotic bronchoscopy technology.

[0024] First, the technical terms described in the present application of a sheath device for blocking bleeding during robotic bronchoscopy are defined as follows: Distal end: refers to the end of a medical device or equipment that is farther from the operator, that is, the end that is closer to the patient's body when in use.

[0025] Proximal end: refers to the end of a medical device or equipment that is closer to the operator, that is, the end that is closer to the doctor or the operating handle of the medical device when in use.

[0026] In the occluding sheath device of the present application, the proximal end is located at the end of the guide tube 1 that is not inserted into the patient's body, and the distal end is located at the end of the guide tube 1 that is inserted into the patient's body.

[0027] In the occluding sheath device of the present invention, the distal end refers to the portion located at the main tube insertion end, including the occluding balloon, which is directly inserted into the bronchus to close the gap between the tube and the bronchus during bleeding.

[0028] See also Figure 1-8 A sheath device for blocking bleeding during robotic bronchoscopy comprises a guide tube 1, a blocking balloon, a medium channel 2 and a pressure device.

[0029] A guide tube 1, wherein a lumen 3 is formed inside the guide tube 1, and the lumen 3 serves as a guide channel of the bronchoscope, and the guide channel is used to insert the bronchoscope and guide the bronchoscope to a target position; The blocking balloon is arranged on the outer wall of the distal end of the guide tube 1 . The blocking balloon can expand and deform along the circumference of the guide tube 1 under pressure to block the bronchus and / or the lumen of the guide tube 1 .

[0030] The medium channel 2 is arranged in the tube wall of the guide tube 1 and along the axial direction of the guide tube 1 . One end of the medium channel is connected to the blocking balloon, and the other end extends to the proximal end of the guide tube 1 .

[0031] The pressure device is communicated with the proximal end of the medium channel 2 and is used to inject pressure medium into the blocking balloon through the medium channel 2.

[0032] The principle of the blocking sheath device is to achieve rapid control of intraoperative bronchial bleeding by combining mechanical compression and physical blocking; during bronchoscopy, the guide tube 1 is pre-placed into the target bronchus, and the robotic bronchoscope reaches the lesion through the lumen for biopsy or treatment; when sudden bleeding occurs during the operation, the operator injects a pressure medium (usually air or saline) into the medium channel 2 through a pressure device (such as a syringe or a pressure pump), so that the blocking balloon forms a circumferential expansion along the distal outer wall of the guide tube 1 within a few seconds, or / and, the blocking balloon deforms and expands toward the center of the lumen and compresses the bronchoscope. After the balloon is expanded, its diameter can be expanded to 2-3 times the original inner diameter of the bronchus, forming radial compression on the bronchial wall or / and the bronchoscope, achieving blocking between the guide tube 1 and the bronchial mucosa, or / and, blocking between the inner wall of the guide tube and the bronchoscope; During the blocking process, the blocking balloon fits tightly against the bronchial mucosa, blocking the blood flow along the bronchial axis to the proximal airway, blocking the distal bronchial cavity 3, preventing blood from flowing back into the healthy lung segment, and reducing the risk of suffocation; at the same time, the blocking balloon deforms evenly under the action of pressure, directly compresses the bleeding point or adjacent tissue through uniform pressure distribution, promotes local vasoconstriction and thrombosis; secondly, after the bronchoscope is withdrawn, the blocking balloon continues to deform under pressure, which can also achieve the blocking of the lumen, solving the problem of blood reflux to the proximal end.

[0033] The occluding sheath device of the present application integrates the occluding balloon on the guiding tube 1, and the occlusion can be initiated without withdrawing the robotic bronchoscope, thus avoiding the loss of field of view and difficulty in secondary positioning due to the withdrawal of the scope; the lumen of the guiding tube 1 can also be compatible with other standard treatment instruments (such as suction tubes, drug delivery catheters), and hemostasis and etiology treatment can be carried out simultaneously; the occluding sheath device converts passive hemostasis into active occlusion, reduces the risk of operation-related bleeding, and promotes the popularization and application of robotic bronchoscopes to high-risk cases (such as patients with paravascular nodules and coagulation disorders).

[0034] In some embodiments, the blocking balloon is a blocking ring formed at the distal end of the guide pipe 1 , and the blocking ring is provided with an air inlet 7 , which is connected to the air outlet at the distal end of the medium channel 2 .

[0035] Optionally, the sealing ring forms a sealing ring shape in an expanded and deformed state, and the interior of the sealing ring is a cavity, which serves as a accommodating chamber for the pressure medium. The air inlet 7 is arranged on the inner ring wall of the sealing ring. The sealing ring is fixedly sleeved on the distal end of the guide pipe 1, and the fixing method is bonding. It should be noted that the inner diameter of the sealing ring is slightly smaller than the outer diameter of the guide pipe 1. In this way, during the assembly process of the sealing ring, the sealing ring is sleeved on the guide pipe 1 and forms an annular seal, and then it is bonded and fixed, and the air inlet 7 of the sealing ring is connected to the medium channel 2, to ensure that the pressure medium can smoothly enter the sealing ring so that it is deformed and sealed under the action of pressure.

[0036] The sealing ring is an elastic sealing film. When no pressure medium is injected, that is, in the initial state, the sealing ring is attached to the outer wall of the distal end of the guide tube 1. This does not increase the diameter of the guide tube 1, so that the guide tube 1 can be inserted into a lobar bronchus with a smaller diameter.

[0037] Optionally, the cross-section of the blocking ring after deformation and expansion is hemispherical, which can increase the contact area between the blocking ring and the guide pipe 1 and ensure the stability of the connection between the blocking ring and the guide pipe 1.

[0038] Optionally, a plurality of separation membranes 8 are provided in the sealing ring, and the plurality of separation membranes 8 are arranged at intervals along the circumference of the sealing ring to divide the sealing ring into a plurality of independent pressure chambers 6, and each pressure chamber 6 is provided with an air inlet 7; correspondingly, a plurality of medium channels 2 are provided in the guide pipe 1, and the number of the medium channels 2 is the same as the number of the pressure chambers 6. Injecting pressure medium into the plurality of pressure chambers 6 through the plurality of medium channels at the same time can effectively increase the deformation rate of the sealing ring, and at the same time can also control the pressure of the plurality of pressure chambers 6 according to the shape of the bronchus, so that the shape after expansion and deformation is more compatible with the bronchus, thereby ensuring the pressure balance of the bronchus.

[0039] The blocking balloon is an elastic blocking film formed on the outer wall of the guide pipe 1, and the two sides of the elastic blocking film are fixed to the outer wall of the guide pipe 1, and the air inlet 7 of the medium channel is located in the coverage area of ​​the elastic blocking film, and the elastic blocking film and the guide pipe 1 are fixed by bonding, heat sealing, etc.; similarly, the elastic blocking film is attached to the guide pipe 1 in the initial state (no pressure medium is injected), and produces an annular expansion deformation after the pressure medium is injected.

[0040] In some embodiments, a constraint structure is provided on the outer surface of the blocking balloon for constraining the maximum deformation state of the blocking balloon.

[0041] The occluding balloon is used to stop bleeding during bronchoscopic surgery. It occludes the bronchus by expanding with pressure. If the pressure of the occluding balloon is too high (for example, the pressure device is out of control or the pressure is too high), the occluding balloon will damage the bronchial wall. Therefore, the maximum expansion state of the balloon is limited to ensure that even if the pressure is too high, the occluding balloon will not over-expand and cause damage to the bronchus. Therefore, a constraint structure is covered on the occluding balloon to constrain the maximum deformation of the occluding balloon to ensure the safety of bronchoscopy.

[0042] Optionally, the constraint structure is an elastic constraint net 10, which covers the surface of the occluding balloon, and the elastic constraint net 10 is arrayed with diamond meshes or hexagonal honeycomb meshes.

[0043] The elastic constraint net 10 needs to be biocompatible, comply with the biocompatibility standards of medical devices, and meet the requirements of short-term contact with mucosa. At the same time, its elastic modulus and elongation at break are greater than ≥300% to adapt to the dynamic expansion process of the occluding balloon, and it also has a certain fatigue resistance and a certain degree of reusability.

[0044] The elastic constraint net 10 is made of medical polyurethane, thermoplastic polyurethane, polyether block amide or composite fiber material, preferably medical polyurethane. Medical polyurethane can generate significant resistance when the balloon is expanded to a preset diameter, and its high elongation at break ensures uniform expansion of the mesh and avoids local stress concentration; the surface can be modified to increase lubricity (such as hydrophilic coating) to reduce friction with the airway mucosa.

[0045] Furthermore, radioactive imaging strips (containing barium sulfate) were printed on the surface of the restraining mesh, and the expansion diameter was monitored in real time by intraoperative fluoroscopy. The elongation at break of the restraining mesh was set to 110% of the clinically safe diameter (e.g., bronchial inner diameter 8mm → expansion limited to 8.8mm), and the mesh changed color when the limit was exceeded.

[0046] Optionally, a fiber Bragg grating (FBG) sensor is embedded in the balloon wall to monitor the expansion diameter in real time (accuracy ±0.1 mm) and feed back to the pressure device.

[0047] In some embodiments, the blocking balloon includes an outer balloon 5 and an inner balloon 4 , the outer balloon 5 is located on the outer wall of the distal end of the guide tube 1 , and the inner balloon 4 is located on the inner wall of the distal end of the guide tube 1 .

[0048] Optionally, the outer balloon 5 and the inner balloon 4 are located at the same position at the distal end of the guide tube 1, and both the outer balloon 5 and the inner balloon 4 are elastic blocking films; the structure of the outer balloon 5 can adopt the above-mentioned structure and will not be repeated here, and the inner balloon 4 will be described in detail below.

[0049] The inner balloon 4 is an elastic blocking film, both sides of which are fixedly connected to the inner wall of the guide pipe 1 , and the outlet of the medium channel 2 is in communication with the inner balloon 4 .

[0050] In order to facilitate the setting of the inner balloon 4, it is preferred to fix the inner balloon 4 at the distal end of the guide tube 1. When setting the inner balloon 4, an expansion device can be used to expand the distal end of the guide tube 1, and then the elastic sealing film is fixed to form the inner balloon 4.

[0051] When emergency bleeding occurs during bronchoscopy, pressure medium is injected into the outer balloon 5 and the inner balloon 4 respectively, so that the outer balloon 5 deforms to block the space between the guide tube 1 and the bronchus, and the inner balloon 4 expands and deforms centripetally and covers the bronchoscope to block the guide tube 1. When switching to other interventional treatment interventions, the robotic bronchoscope is quickly withdrawn, and at the same time, the pressure of the inner balloon 4 is controlled to cause it to continue to deform until it completely blocks the lumen 3 of the guide tube 1, and then other interventional treatment interventions are performed to stop the bleeding.

[0052] Optionally, the inner balloon 4 includes two sub-balloons 9 symmetrically arranged along the axis of the guide tube 1 . When the bronchoscope is withdrawn, the two sub-balloons 9 form two hemispherical structures to block the lumen 3 of the guide tube 1 .

[0053] In some embodiments, the inner balloon 4 includes an elastic sealing body 11, which is a ring-shaped structure. The thickness of the elastic sealing body 11 decreases from the inner wall of the guide tube 1 to the center. A channel 12 is provided in the center of the elastic sealing body 11. In a natural state, the channel 12 is in a closed state under the elastic force of the elastic sealing body 11. When a bronchoscope is inserted, the elastic body is deformed under the pressure of the bronchoscope, and a channel for inserting into the bronchus is formed in the center thereof.

[0054] Optionally, the elastic blocking body 11 includes multiple blocking bodies, and the multiple blocking bodies are circumferentially spaced apart. Similarly, the thickness of the blocking body gradually decreases from the edge to the center. The blocking body is made of elastic material, such as silicone. In the initial state (bronchoscope is not inserted), the multiple blocking bodies block the lumen 3 of the guide tube 1. After the bronchoscope is inserted into the lumen 3, the bronchoscope squeezes the blocking body and passes through the blocking body. The blocking body covers the bronchoscope and provides support for it.

[0055] In some embodiments, the inner cavity of the guide tube 1 needs to be smooth enough to reduce the friction resistance when the flexible arm of the robot bronchoscope is inserted; the wall of the guide tube 1 needs to be as thin as possible to make the diameter of the entire guide tube 1 as small as possible and not occupy the bronchial airway. The guide tube 1 needs to have certain support and flexibility, can bend freely to reach the lobar bronchial opening, and can have a certain support effect on the flexible arm of the robot bronchoscope to help it bend to reach the lesion. Preferably, the guide tube 1 is designed with an outer diameter of 6.0 mm and an inner diameter of 3.3 mm.

[0056] The guide pipe 1 is made of TPU (thermoplastic polyurethane elastomer rubber) material, PBAX (copolymer of polyether amide and polyether components) or PA (polyamide) composite material. The guide pipe 1 needs to have a certain rigidity, flexibility and elasticity. It will not become hard and brittle at low temperatures and maintain consistent resilience in a wide temperature range.

[0057] In some embodiments, the guide tube 1 and the occluding balloon are integrally formed, for example, by multi-layer co-extrusion + selective foaming technology, laser-induced cross-linking molding technology, and printing molding technology.

[0058] In some embodiments, the medium channels 2 include at least two, respectively together with the inner balloon 4 and the outer balloon 5 , and the medium channels 2 are arranged in the wall of the guide pipe 1 and arranged in a conformal manner, that is, arranged along the length direction of the guide pipe 1 .

[0059] In some embodiments, the pressure medium is air or saline, and a pressurizing device is used to inject air or saline into the blocking balloon through the medium to make it expand and deform, thereby achieving blocking of the guide tube 1.

[0060] In some embodiments, the pressure device is an injection pump and a pressure pump. For example, the pressure pump is connected to the medium channel 2 through a pipeline to achieve injection of pressure medium. The controller of the pressure pump receives the pressure value of the pressure sensor and adjusts the injection amount in real time.

[0061] A flow meter may also be provided at the outlet of the pressure pump to determine the pressure of the blocking balloon according to the flow of the pressure medium.

[0062] Example 1 A sheath device for blocking bleeding during robotic bronchoscopy comprises a guide tube 1, a blocking balloon is arranged about 1 cm from the distal end of the guide tube 1, the outer diameter of the guide tube 1 is 6.0 mm, the inner diameter is 3.3 mm, the wall thickness of the guide tube 1 is 1.35 mm, a medium channel 2 is arranged in the tube wall of the guide tube 1, the cross section of the medium channel 2 is a strip structure to increase the area of ​​the medium channel 2, the width is 0.6 mm, and the length is 2 mm, the outlet of the medium channel 2 is connected to the blocking balloon, and the inlet of the medium channel 2 is connected to the inflation pump through a pipeline.

[0063] The inflation pump is located at the distal end of the guide tube 1, and is connected to the blocking balloon through the wall of the sheath tube. The blocking balloon can be inflated or deflated by injecting or sucking gas. The inflation valve operation needs to be simple and convenient to facilitate rapid operation in emergency bleeding scenarios. In the case of bleeding, the blocking balloon can be quickly inflated through the inflation valve at the proximal end of the guide tube 1. After the blocking balloon is opened, the gap between the guide tube 1 and the bronchus is completely blocked.

[0064] Example 2 In this embodiment, only the position of the medium channel is optimized, and the rest of the structure is the same as that of Embodiment 1. In this embodiment, the medium channel serves as an independent pipeline.

[0065] A sheath device for blocking bleeding during bronchoscopy comprises a guide tube 1 and a medium tube, wherein a medium channel 2 is formed inside the medium tube and the medium tube is attached to the outer wall of the guide tube 1.

[0066] The attachment method is bonding, and multiple medium pipes are bonded in parallel to the outer wall of the guide pipe 1. An air inlet hole 7 is set in the area of ​​the guide pipe 1 close to the inner balloon 4. The distal end of one of the guide pipes 1 is connected to one end of the air inlet hole 7, and the other end of the air inlet hole 7 is connected to the inner balloon 4.

[0067] The medium pipeline is parallel to the guide pipeline 1, or the medium pipeline is bonded to the outer wall of the guide pipeline 1 in a spiral winding manner, which can increase the manufacturing difficulty of the guide pipeline 1 and facilitate unblocking and maintenance when the medium pipeline is blocked.

[0068] Example 3 A bronchoscope comprises a bronchoscope assembly and a sheath device for blocking bleeding during bronchoscopy as described in the above embodiment.

[0069] Example 4 A robotic bronchoscope comprises a robot and the bronchoscope described in Example 1.

[0070] The bronchoscope assembly includes the physician console, robotic arm platform, bronchoscope catheter, visual probe, navigation and positioning system, and biopsy tool.

[0071] The doctor operates the robotic arm through the console to control the omnidirectional motion catheter and visual probe to enter the bronchus. The outer diameter of the catheter is 3.5 mm, and the front end has an active bending function of 180 degrees in any direction, which can smoothly pass through complex bronchial branches. With the assistance of fiber optic shape sensing navigation technology, the catheter can accurately reach the target lesion and complete biopsy or other diagnostic and treatment operations. It realizes accurate diagnosis and treatment of lung diseases, making the robotic bronchoscope show great application potential in the field of respiratory intervention.

[0072] See also Fig. 9 and 10 , the following is a detailed description of the use of robotic bronchoscope, including the following process: The lesion area of ​​the bronchus was determined based on the patient's preoperative CT images; During the operation, the guide tube 1 is inserted into the bronchus 100. The guide tube 1 serves as a guide channel for the bronchoscope 200. During the insertion of the guide tube 1, the occluding balloon is ensured to be in an uninflated state. At this time, the occluding balloon is attached to the outer wall of the bronchus, and the proximal end of the guide tube is connected to the inflation pump through a tube.

[0073] The robotic arm controls the bronchoscope to enter the guide channel 1 and advance it along the planned path to the target bronchus. Electromagnetic navigation (accuracy ±1.2 mm) and OCT real-time scanning are used to confirm the location of the lesion, and a biopsy forceps is inserted through the guide channel for sampling.

[0074] When bleeding is detected, the inflation pump is immediately started to inflate the two blocking balloons. The circumferentially expanded blocking balloons (covered with the elastic constraint net 10) compress the bronchial wall and block the blood flow to the proximal end. At the same time, the FBG sensor feeds back the diameter data in real time and dynamically adjusts the pressure to a stable value. At the same time, the inner balloon 4 deforms to cover the bronchoscope and blocks the gap in the lumen 3.

[0075] When the bronchoscope is withdrawn and other interventional treatments are used, the pressure of the inner balloon 4 is controlled to completely block the lumen 3, and then other interventional treatments are used to stop bleeding, for example, drainage of bleeding through the guide tube 1 and injection of hemostatic glue for hemostasis.

[0076] The present application provides a sheath device for blocking bleeding during robotic bronchoscopy, which is mainly used for emergency treatment of emergency bleeding that may occur during the operation of a robotic bronchoscopy. The device can improve the safety of robotic bronchoscopy, effectively deal with life-threatening massive bleeding scenarios that may occur during surgery, reduce the surgical risk of patients, and provide a new solution for emergency treatment of bleeding during surgery in robotic bronchoscopy systems, which has good commercial value and clinical application prospects.

[0077] The above contents are only for explaining the technical idea of ​​the present invention and cannot be used to limit the protection scope of the present invention. Any changes made on the basis of the technical solution in accordance with the technical idea proposed by the present invention shall fall within the protection scope of the claims of the present invention.

Claims

1. A sheath blocking device for bleeding during robotic bronchoscopy, characterized in that: It comprises a guide pipe (1), a blocking balloon, a medium channel (2) and a pressure device; The guide tube (1) has a lumen (3) formed inside, and the lumen is capable of allowing a bronchoscope to pass through and enter the lesion location; The blocking balloon is arranged at the distal end of the guide tube (1), and can expand and deform along the radial direction of the guide tube (1) under pressure, so as to block the bronchus and / or the lumen; The medium channel (2) is arranged on the guide tube (1) and is arranged along the axial direction of the guide tube (1); one end of the medium channel is connected to the blocking balloon, and the other end extends to the proximal end of the guide tube (1); The pressure device is communicated with the proximal end of the medium channel (2) and is used to inject pressure medium into the blocking balloon through the medium channel (2).

2. A sheath device for blocking bleeding during robotic bronchoscopy according to claim 1, characterized in that: The blocking balloon includes a blocking ring or an elastic blocking film; A medium cavity is formed inside the blocking ring, the blocking ring is sleeved and fixed on the outer wall of the distal end of the guide pipe (1), and a medium hole is provided on the blocking ring and is in communication with the distal end of the medium channel (2); The elastic blocking film surrounds the outer wall of the distal end of the guide pipe (1), and two sides of the elastic blocking film are fixedly connected to the outer wall of the guide pipe (1).

3. The device for blocking bleeding during robotic bronchoscopy according to claim 2, characterized in that: The ring wall of the blocking ring is a film; The sealing ring is attached to the outer wall of the distal end of the guide pipe (1) when no pressure medium is injected.

4. The device for blocking sheath tube during bleeding in robotic bronchoscopy according to claim 1, characterized in that: A plurality of pressure chambers (6) are provided in the blocking balloon, the plurality of pressure chambers (6) are arranged in a ring, and each pressure chamber (6) is connected to a medium channel (2).

5. The sheath device for blocking bleeding during robotic bronchoscopy according to claim 1, characterized in that: The outer surface of the blocking balloon is provided with a constraint structure for constraining the maximum deformation state of the blocking balloon; The restraining structure is an elastic restraining net (10) which covers the surface of the blocking balloon.

6. The sheath device for blocking bleeding during robotic bronchoscopy according to claim 1, characterized in that: A fiber Bragg grating sensor is embedded on the surface of the blocking balloon to detect the pressure between the blocking balloon and the bronchus.

7. The sheath device for blocking bleeding during robotic bronchoscopy according to claim 1, characterized in that: A blocking device is provided at the distal end of the lumen (3) of the guide tube, and is used to block the gap between the lumen (3) or the inner wall of the guide tube and the bronchoscope.

8. The sheath device for blocking bleeding during robotic bronchoscopy according to claim 7, characterized in that: The blocking device is an inner balloon (4) or an elastic blocking body (11); The inner balloon (4) is an elastic blocking film, and two sides of the elastic blocking film are fixedly connected to the inner wall of the guide tube (1); The elastic blocking body (11) is an annular structure, the thickness of the elastic blocking body (11) gradually decreases from the inner wall of the guide pipe (1) to the center, and a hole (12) is provided at the center of the elastic blocking body (11); When the bronchoscope is not inserted, the hole (12) is in a closed state under the elastic force of the elastic blocking body (11).

9. The sheath device for blocking bleeding during robotic bronchoscopy according to claim 1, characterized in that: The medium channel (2) is arranged in the pipe wall of the guide pipe (1); Alternatively, the medium channel (2) is arranged in a medium pipeline, and the medium pipeline is arranged on the pipe wall of the guide pipeline (1).

10. A robotic bronchoscopy system, characterized in that: A sheath device for blocking bleeding during robotic bronchoscopy comprising any one of claims 1-9.

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