A sheathing system

Abstract

The application provides a sheathing system convenient to push, which comprises a sheath, a resistance detection piece, a pressure detection piece, a perfusion device and a controller; the controller is in communication connection with the pressure detection piece, the resistance detection piece and the perfusion device; the controller is configured to execute a sheathing method, which comprises the following steps: in the process of pushing the sheath into a human body cavity, when the resistance detection piece detects that the pushing resistance reaches a highest warning resistance value, the perfusion device opens a perfusion mode to send a perfusion liquid into the cavity to expand the cavity; if the sheathing resistance decreases after the cavity is expanded, the sheath is continuously pushed; if the pressure in the cavity reaches a highest warning pressure value after the cavity is expanded by the perfusion liquid, and the sheathing resistance still exceeds the highest warning resistance value, it is proved that the volume of the perfusion expanded cavity is limited, and a small-specification sheath is replaced; the small-specification sheath is pushed into the cavity, and if the sheathing resistance of the small-specification sheath still exceeds the highest warning resistance value, it is determined that the cavity is blocked.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and specifically relates to a sheath insertion system and a sheath insertion method that is convenient for pushing into a cavity. Background Art

[0002] In the operation of medical devices, especially when pushing a sheath through a narrow or curved lumen, the resistance inside the lumen is one of the key factors affecting the success of the operation. In current technology, the judgment of resistance mainly relies on the doctor's experience and feel, and lacks accurate detection methods. This method may lead to excessive pushing force in some complex situations (such as stenosis, large curvature or tissue adhesion), thereby damaging the lumen and even causing serious complications such as bleeding or perforation. In addition, during the process of the sheath entering the lumen, the resistance is not constant, but changes with the lumen state during the pushing process (such as the degree of expansion or the reaction of the tissue around the lumen), which further increases the difficulty of the operation. In order to improve the success rate of sheath insertion and reduce operational risks, there is an urgent need for a technology that can detect the pushing resistance in real time and adjust the pushing strategy in time according to the resistance changes. Existing sheath insertion methods generally lack accurate monitoring of resistance, making it difficult to determine when to adjust the pushing force or change the size of the instrument during the pushing process, increasing the uncontrollability of the operation and the risk of lumen damage. Therefore, accurate resistance detection technology is crucial to ensure smooth and safe sheath insertion operations. Summary of the Invention

[0003] The present invention provides a sheath insertion system that is easy to push, and the sheath insertion system includes:

[0004] The sheath comprises a sheath seat, a sheath tube, an irrigation connector and an aspiration connector, wherein the sheath seat is arranged at the proximal end of the sheath tube, the irrigation connector and the aspiration connector are arranged on the sheath seat, the sheath tube defines a channel for external instruments to pass through, and the sheath tube is suitable for entering a human body cavity;

[0005] A resistance detection member is provided on the sheath to detect the movement resistance of the sheath tube entering the human body cavity and to provide feedback on the resistance value;

[0006] A pressure detection element, which is used to detect the pressure in the human body cavity and is suitable for being arranged on the endoscope or the sheath;

[0007] An irrigation device is connected to the irrigation connector to deliver irrigation liquid into the human body cavity through the sheath channel;

[0008] a controller, which is in communication with the pressure detection element, the resistance detection element, and the perfusion device;

[0009] The controller is configured to execute a sheathing method, the sheathing method comprising the following steps:

[0010] Step 1) Preset a maximum warning resistance value and a maximum warning pressure value, wherein the resistance detection component is used to detect the resistance of the sheath entering the lumen, and the pressure detection component is used to detect the pressure in the lumen in real time;

[0011] Step 2) During the process of pushing the sheath into the human body cavity, when the resistance detection component detects that the pushing resistance reaches the maximum warning resistance value, the perfusion device starts the perfusion mode to send perfusion liquid into the cavity to expand the cavity. There are two situations here. The first situation is: if the sheath push resistance decreases after the cavity is expanded, the sheath is continued to be pushed. This situation indicates that the large sheath push resistance here is due to the large sheath push resistance caused by the stenosis of the cavity; the second situation is that if the pressure in the cavity reaches the maximum warning pressure value after the cavity is expanded by perfusion liquid, if the sheath push resistance still exceeds the maximum warning resistance value, it proves that the volume of the perfusion expansion cavity is limited and the sheath is still difficult to move forward. In this case, consider replacing a smaller sheath.

[0012] Step 3) Push the small-sized sheath into the lumen, and repeat the sheath pushing method of step 2). If the sheath insertion resistance of the small-sized sheath still exceeds the maximum warning resistance value, it is determined that the lumen is blocked.

[0013] In some embodiments, the sheath insertion system further includes a suction device, the controller is in communication with the pressure detection component, the resistance detection component, the irrigation device, and the suction device, and the irrigation device cooperates with the suction device to maintain a suitable pressure in the cavity.

[0014] In some embodiments, the controller is configured to perform a sheathing method, the sheathing method comprising the following steps:

[0015] Step 1): The maximum warning resistance value, the maximum warning pressure value, the minimum warning pressure value, and the pressure control value are preset. The controller controls the perfusion device to deliver the perfusion liquid into the body cavity and can control the suction device to extract the liquid in the body cavity:

[0016] Step 2): During the sheath advancement process, when the resistance detection component detects that the resistance reaches the highest warning resistance value, the perfusion device activates the perfusion mode to expand the lumen. When the pressure in the lumen reaches the highest warning pressure value, the perfusion device stops perfusion and continues to push the sheath tube. If the sheath advancement resistance decreases, the sheath advancement continues. When the sheath tube reaches the target position, the suction device activates the suction mode to reduce the pressure in the lumen.

[0017] If the resistance to sheath entry does not decrease after the perfusion device is filled with liquid, the pressure in the cavity should be regulated to the control value by coordinating the perfusion device and the suction device, and a smaller sheath should be replaced.

[0018] Step 3) After replacing the small-sized sheath, reinsert the sheath. If the sheath insertion is smooth, it is considered to be a case of local stenosis of the lumen. If the resistance reaches the maximum warning resistance value when reinsert the sheath, repeat the sheath pushing method of step 2). If the sheath insertion resistance does not decrease after the perfusion device is perfused with liquid and still exceeds the maximum warning resistance value, it is determined to be a case of lumen obstruction.

[0019] In some embodiments, the sheath advancement system is configured with multiple sheath advancement modes, and different sheath advancement modes have different maximum warning resistance values. The sheath advancement modes include at least a high-resistance sheath advancement mode and a low-resistance sheath advancement mode. The appropriate sheath advancement mode is selected according to the diameter, curvature, and elastic toughness of the sheath advancement path.

[0020] In some embodiments, the sheath insertion method includes a pressure control method in the cavity, which includes: adjusting the perfusion and suction parameters according to the real-time monitored pressure value and the data change trend of the pressure value, so that the current cavity pressure is balanced at the pressure control value, and a balanced state of perfusion and suction is achieved. The perfusion parameters include the perfusion flow gear, and the suction parameters include the opening of the pressure relief valve and the suction pressure threshold. The suction pressure threshold is the suction pressure threshold of the suction container preset by the controller, and the start and stop of the suction pump are controlled by setting the suction pressure threshold.

[0021] In some embodiments, the sheath defines a pressure measuring channel extending from the proximal end toward the distal end, the distal end of the pressure measuring channel forms at least one pressure measuring port for sensing the pressure in the cavity, and a pressure detection component is provided on the pressure measuring channel or any path connected thereto.

[0022] In some embodiments, the sheath seat is provided with a pressure measuring interface communicating with the pressure measuring channel, and the pressure measuring interface is suitable for connecting with the pressure detecting element.

[0023] In some embodiments, if the sheath entry channel is a ureter with good elasticity and strong toughness, the high-resistance sheath entry mode is selected; and for a ureter with poor elasticity, the low-resistance sheath entry mode is selected.

[0024] In some embodiments, if the sheath entry channel has a large curvature, a low-resistance sheath entry mode is selected; if the sheath entry channel has a small curvature, a high-resistance sheath entry mode is selected.

[0025] In some embodiments, if the sheath entry channel has a large diameter, a high-resistance sheath entry mode is selected; if the sheath entry channel has a narrow diameter, a low-resistance sheath entry mode is selected.

[0026] The present invention provides a sheath insertion method which simplifies the physician's operation during surgery by comprehensively regulating pressure, resistance and perfusion, reduces the risk caused by operational errors, and improves the safety and efficiency of the sheath insertion process. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Fig. 1 A schematic structural diagram of the sheath insertion system provided by the present invention;

[0028] Fig. 2 A schematic structural diagram of the sheath provided by the present invention;

[0029] Fig. 3 This is a cross-sectional view of the structure of the sheath provided by the present invention. DETAILED DESCRIPTION

[0030] The present invention or the technical solution of the invention will be further described in detail below through specific embodiments and in conjunction with the accompanying drawings.

[0031] In the description of the present invention, it should be understood that the terms "front," "back," "upper," "lower," etc., indicating directions or positions, are based on the directions or positions shown in the accompanying drawings and are intended solely to facilitate the description of the present invention and simplify the description. They are not intended to indicate or imply that the devices or components referred to must have a specific direction, be constructed, or operate in a specific direction. Therefore, they should not be construed as limitations on the present invention. In this application, the proximal end should be interpreted as the portion closer to the operator (doctor), while the distal end should be understood as the portion farther away from the doctor.

[0032] In the description of the present invention, it should be noted that, unless otherwise specified and limited, the terms "installation" and "connection" should be understood in a broad sense. For example, it can be a mechanical connection or an electrical connection, or it can be the internal connection between two components. It can be a direct connection or an indirect connection through an intermediate medium. For ordinary technicians in this field, the specific meanings of the above terms can be understood according to specific circumstances.

[0033] See also Figs. 1-3The present invention provides a sheath insertion system that is easy to push. The sheath insertion system includes a sheath and an irrigation and suction system. The irrigation and suction system includes an irrigation device, a suction device and a controller. The sheath includes a sheath seat 2, a sheath tube 1, an irrigation joint 21, a suction joint 22 and a resistance detection component 6. The sheath seat 2 is arranged at the proximal end of the sheath tube 1. The sheath seat 2 has an irrigation joint 21 and a suction joint 22. The suction joint 22 is suitable for connecting with a suction device. The irrigation joint 21 is suitable for connecting with the irrigation device. The irrigation device infuses liquid into the body cavity through the irrigation joint 21. The suction device sucks waste liquid and stones out of the body through the suction joint 22. The sheath tube 1 defines a channel 110 for external instruments such as a uroscope 3 to pass through. The sheath tube 1 is suitable for entering the human body cavity. The resistance detection component 6 is arranged on the sheath to detect the movement resistance of the sheath tube entering the human body cavity and feedback the resistance value. Specifically, the resistance detection element 6 is mounted on the sheath tube 1 and is used to monitor the contact force between the sheath tube 1 and the cavity wall during the pushing process. Resistance detection can be achieved in a variety of ways, such as using a strain gauge, pressure sensor, or micro force sensor to sense the change in external resistance during the movement of the sheath tube into the cavity. This can provide real-time feedback to the operator on the cavity status, reducing the risk of blind operation and avoiding cavity damage caused by excessive resistance. If the resistance is too high, the doctor can replace the sheath with a smaller size or expand the cavity by perfusing liquid into the cavity to facilitate smooth sheath insertion. If the above methods are still difficult to implement, it is necessary to consider that the cavity is blocked and it is not suitable to continue forcing the sheath.

[0034] In some embodiments of the present invention, the sheath insertion system further includes a pressure detection component 5, which is used to detect the pressure in the human body cavity. The pressure detection component 5 can be provided on an endoscope or a sheath to detect the pressure in the human body cavity in real time. The perfusion device is connected to the perfusion connector 21 to deliver the perfusion liquid into the human body cavity through the sheath tube 1 channel; the controller is communicatively connected to the pressure detection component, the resistance detection component and the perfusion device. Furthermore, the sheath tube 1 defines a pressure measuring channel 111 extending from the proximal end toward the distal end, and the distal end of the pressure measuring channel 111 forms at least one pressure measuring port for sensing the pressure in the cavity. The pressure detection component is provided on the pressure measuring channel or any path connected thereto. Exemplarily, the pressure sensor is provided at the distal end of the pressure measuring channel. The sheath seat is provided with a pressure measuring interface 112 connected to the pressure measuring channel, and the pressure measuring interface is suitable for connection with the pressure detection component 5.

[0035] In one embodiment of the present invention, the irrigation device includes a liquid inlet tube 10, a liquid storage bag 11, and an irrigation pump. The irrigation pump is connected to the liquid storage bag 11 through the liquid inlet tube 10; the irrigation pump is connected to the irrigation connector 21 on the sheath seat through the liquid outlet tube 12. The suction device is connected to the sheath tube 1, and the suction device includes a diaphragm pump, a first negative pressure suction tube 91, a suction container 93, and a second negative pressure suction tube 92. One end of the first negative pressure suction tube 91 is connected to the diaphragm pump, and the other end is connected to the suction container 93. One end of the second negative pressure suction 92 is connected to the suction container 93, and the other end is connected to the suction connector 22 of the sheath. In this way, during long-term laser operation, the operation time lasts for a long time, and the irrigation device injects liquid into the body to reduce the temperature in the cavity. However, too much liquid in the cavity will cause excessive pressure in the cavity. The doctor can use the suction device to suck the liquid in the cavity out of the body to reduce the pressure in the cavity. In this embodiment, the perfusion pump, diaphragm pump and controller are integrated on the same main control machine 100, and the pressure detection component 5 and the resistance detection component 6 are connected to the controller of the main control machine 100 through the cavity pressure harness 51 and the resistance harness 61 respectively. In this way, the structure of the entire perfusion and suction system is greatly simplified. The detection and control of perfusion, suction, pressure and resistance can be achieved through one main control machine. The doctor can realize the flow rate of perfusion and suction through the main control machine. In some preferred embodiments, the flow rate level of perfusion and suction can be adjusted in real time by the cavity pressure feedback from the pressure detection component. For example, if the pressure detection component detects that the perfusion pressure is too high, the suction pressure is increased to reduce the pressure in the cavity.

[0036] The resistance detection element 6 facilitates the doctor to timely understand the pushing resistance of the sheath tube during the process of pushing the sheath tube into the cavity. In some embodiments of the present invention, a sheath insertion method based on the resistance detection element is provided, and the sheath insertion method comprises the following steps:

[0037] Step 1): Preset the maximum warning resistance value, the minimum warning resistance value, and the maximum warning pressure value. The resistance detection component is used to detect the resistance of the sheath entering the cavity, and the pressure detection component is used to detect the pressure in the cavity in real time.

[0038] Step 2): During the process of pushing the sheath into the human body cavity, when the resistance detection component detects that the pushing resistance reaches the maximum warning resistance value, the perfusion device turns on the perfusion mode to send the perfusion liquid into the cavity to expand the cavity. There are two situations here. The first situation: if the sheath push resistance decreases after the cavity is expanded, the sheath continues to be pushed. This situation indicates that the large sheath push resistance here is due to the large sheath push resistance caused by the stenosis of the cavity. The second situation is that if the cavity is expanded by perfusing the liquid, the pressure in the cavity reaches the maximum warning pressure value, and the sheath push resistance still exceeds the maximum warning resistance value, it proves that the volume of the perfusion expansion cavity is limited, and the sheath is still difficult to move forward. At this time, consider replacing a small-sized sheath;

[0039] Step 3): Push the small-sized sheath into the cavity, and repeat the sheath pushing method of step 2). If the sheath pushing resistance of the small-sized sheath still exceeds the maximum warning resistance value, it proves that the sheath pushing resistance of the small-sized sheath is also too large. At this time, it is considered that the cavity is blocked, and the sheath cannot be pushed forcibly. It can be verified by a visual device such as an endoscope. In this way, the present invention sets a resistance detection part on the sheath. When the resistance detection part on the sheath detects that the resistance of the sheath moving into the cavity exceeds the maximum warning resistance value, the perfusion device automatically starts and injects perfusion liquid into the cavity to expand the cavity, thereby reducing the pushing resistance of the sheath. This method effectively avoids cavity damage caused by excessive resistance during the sheath pushing process and improves the safety of the operation. It is worth noting that when the method of expanding the cavity by the perfusion device cannot effectively reduce the resistance, or when the cavity pressure reaches the maximum warning value due to excessive perfusion liquid, the sheath pushing system will prompt to replace the small-sized sheath for further operation. This flexible multi-specification sheath switching mechanism helps to continue operation under complex cavity conditions and avoid operation interruption caused by excessive resistance. Furthermore, after replacing the small-sized sheath, if the resistance still exceeds the warning value, the system can automatically determine that the cavity is blocked, avoiding further damage that may be caused by continuing the operation under blockage, providing doctors with an effective judgment basis and improving the accuracy of diagnosis.

[0040] In some preferred embodiments of the present invention, the controller is in communication with the pressure detection element, the resistance detection element, the perfusion device, and the suction device. The perfusion device and the suction device cooperate to maintain a suitable pressure in the cavity. The main control machine is configured to execute a sheath insertion method, which includes the following steps:

[0041] Step 1): The maximum warning resistance value, the maximum warning pressure value, the minimum warning pressure value, the pressure control value, and the perfusion flow rate gear are preset. The controller controls the perfusion device to deliver the perfusion liquid into the body cavity, and can control the suction device to suck the liquid in the body cavity out of the body: the "pressure control value" here refers to the preset ideal pressure value or pressure range in the cavity, and the "warning pressure value" here refers to the state where the pressure difference between the pressure in the cavity and the pressure control value exceeds this value;

[0042] Step 2): During the sheath advancement process, when the resistance detection component detects that the resistance reaches the highest warning resistance value, the perfusion device activates the perfusion mode to expand the lumen. When the pressure in the lumen reaches the highest warning pressure value, the perfusion device stops perfusion and continues to push the sheath tube. If the sheath advancement resistance decreases, the sheath advancement continues. When the sheath tube reaches the target position, the suction device activates the suction mode to reduce the pressure in the lumen.

[0043] If the resistance to sheath insertion does not decrease after the perfusion device is filled with liquid, the pressure in the cavity is regulated to the pressure control value through the cooperation of the perfusion device and the suction device. At this time, the sheath cannot be inserted any further and a smaller sheath needs to be replaced.

[0044] Step 3) After replacing the small-sized sheath, reinsert the sheath. If the sheath insertion is smooth, it is considered to be a case of local stenosis of the cavity; after replacing the small-sized sheath, reinsert the sheath. When the resistance detection component detects that the resistance reaches the maximum warning resistance value, repeat the sheath pushing method of step 2). Specifically, the perfusion device turns on the perfusion mode to expand the cavity. When the pressure in the cavity reaches the maximum warning pressure value, the perfusion device stops perfusion and continues to push the sheath tube. If the sheath insertion resistance decreases, the sheath is continued to be inserted. When the sheath tube reaches the target position, the suction device turns on the suction mode to reduce the pressure in the cavity. If the sheath insertion resistance does not decrease after the perfusion device perfuses the liquid and still exceeds the maximum warning resistance value, the pressure in the cavity is regulated to be at the pressure control value through the cooperation of the perfusion device and the suction device. At this time, the system determines that the cavity is blocked.

[0045] In this embodiment, through the coordinated cooperation of the suction device and the perfusion device, the sheath advancement system can adjust the pressure in the cavity in real time during the sheath advancement process to ensure that the cavity is in an appropriate pressure range. The controller can automatically start or stop suction and perfusion according to the pressure value in the cavity fed back by the pressure detection component, achieving a balanced state of perfusion and suction, which can effectively avoid excessive expansion or collapse of the cavity, thereby maintaining the stability of the cavity and ensuring smooth operation. After replacing the small-sized sheath, if the sheath advancement resistance is still detected to exceed the warning value, the system can automatically determine that the cavity is blocked, avoiding the doctor's continued pushing and causing cavity damage. Through this intelligent judgment, the system provides a clear decision-making basis for the operation and avoids complications caused by blind operation.

[0046] In this embodiment, the sheath insertion cavity is expanded by perfusion to achieve the reduction of the sheath insertion resistance. However, perfusion will bring about changes in pressure. Based on this, the sheath insertion method provided in this embodiment also includes a pressure control method in the cavity. The method includes: adjusting the perfusion and suction parameters according to the real-time monitored pressure value and the data change trend of the pressure value, so that the current cavity pressure is balanced at the pressure control value, and the equilibrium state of perfusion and suction is achieved. The perfusion parameters include the perfusion flow gear, and the suction parameters include the opening of the pressure relief valve and the suction pressure threshold. The suction pressure threshold is the suction pressure threshold of the suction container preset by the controller. The suction pressure threshold is set to control the start and stop of the suction pump. This pressure control method can select the pressure control method announced in CN116983498B. By optimizing the pressure control, it is ensured that the cavity will not be damaged while the cavity is expanded.

[0047] In one embodiment of the present application, the sheathing system is configured with multiple sheathing modes, each sheathing mode having a different maximum alerting resistance value, and the sheathing modes include at least a high-resistance sheathing mode and a low-resistance sheathing mode, the maximum alerting resistance value of the high-resistance sheathing mode being greater than that of the low-resistance sheathing mode. The physician selects a suitable sheathing mode according to the diameter, curvature and elastic toughness of the sheathing path, so that the system can accurately control the pushing force of the sheath, ensure the implementation of a suitable pushing force range (e.g. 0.5-5N) under different lumen conditions, and avoid the use of excessive pushing force to cause ureter injury, tearing or perforation. Precise force control adjustment greatly reduces the operation risk, and is particularly suitable for ureter, which is a thin lumen structure that is easily damaged. Multiple sheathing modes can be selected, such as a high-resistance sheathing mode, a medium-resistance sheathing mode and a low-resistance sheathing mode, each sheathing mode corresponding to a different maximum alerting resistance value, i.e. a different pushing force.

[0048] The relationship between the pushing force and the sheathing lumen is explained in detail below.

[0049] If the sheath insertion lumen is a ureter with good elasticity and strong toughness, the high-resistance sheath insertion mode is selected; if the sheath insertion lumen is a ureter with poor elasticity, the low-resistance sheath insertion mode is selected. If there is a large bend in the sheath insertion lumen, the low-resistance sheath insertion mode is selected; if the sheath insertion lumen has a small curvature, the high-resistance sheath insertion mode is selected. If the sheath insertion lumen has a large diameter, the high-resistance sheath insertion mode is selected; if the sheath insertion lumen is narrow, the low-resistance sheath insertion mode is selected. In some examples, the sheath insertion lumen is a ureter, and the sheath insertion system has preset high-resistance and low-resistance sheath insertion modes based on the diameter, curvature, and elasticity of the ureter to ensure that the thrust meets the requirements of different lumen conditions. For example, the high-resistance sheath insertion mode can be used for ureters with larger diameters or straighter diameters, while the low-resistance sheath insertion mode can be used for ureters with smaller diameters or larger curvatures. Doctors flexibly select the appropriate sheath insertion mode based on individual anatomical structures, that is, select the appropriate pushing force, reducing the risk of lumen damage and ensuring the safety of the operation. Specifically, the ureteral anatomy shows the diameter of the ureter: the diameter of the ureter in a normal adult is about 3-4 mm, but there are individual differences. If the ureter is thin, a smaller push is required when pushing the ureteroscope to avoid ureteral damage. The push force range is controlled at about 0.5-2N; if the ureter is relatively thick, it may be able to withstand a slightly larger push force, but it should not usually exceed 5N. The degree of ureteral curvature: normal ureters have physiological curvatures, such as at the sacroiliac joint and across the iliac vessels. If the bending angle is large, a smaller and gentler push is required when pushing the sheath to avoid damage. The push force range is controlled at about 0.5-1.5N; and the relatively straight part of the ureter can appropriately increase the push force, and the push force is controlled to not exceed 3N. The elasticity and toughness of the ureter: the elasticity and toughness of the ureters of different individuals are different. Ureters with good elasticity and strong toughness can withstand relatively large thrusts, and the thrust range is controlled within 2-5N; while for ureters with poor elasticity, the thrust range is controlled within 1-3N. Excessive thrust can easily cause ureteral tearing or perforation.

[0050] For example, the present invention provides a method for pushing a sheath into a urinary tract. During the process of pushing the sheath into the urinary tract, the resistance encountered by the sheath varies with the size and stenosis of the urinary tract. During the pushing process, the urinary tract squeezes the pressure sensor on the sheath, and the data from the pressure sensor is fed back to the pressure monitoring instrument. By analyzing the pressure, the resistance to pushing the sheath is determined. When the pushing resistance is too large, the system issues a command, and the perfusion device begins to perfuse to fill the urinary tract. When the urinary tract reaches a certain pressure, the blocked urinary tract is expanded. Then, while the perfusion and suction system continues to perfuse, the doctor pushes the sheath into the expanded urinary tract. When the pressure in the urinary tract is too high, the suction device begins to aspirate the liquid in the urinary tract out of the body. The system operates cyclically according to the pressure detection value of the perfusion and suction system to control the pressure in the urinary tract within the pressure control value range until the sheath successfully reaches the target position in the urinary tract. This system working mode can reduce damage to the patient's urinary tract during the sheath delivery process.

[0051] The various embodiments of the present invention significantly improve the safety, flexibility and accuracy of sheath insertion operations through intelligent control systems, real-time monitoring, automatic feedback adjustment and other technologies, ensuring the protection of the lumen and the success rate of the operation.

[0052] Throughout this specification, references to terms such as "one embodiment," "some embodiments," "specific examples," or "some examples" mean that the specific features, structures, materials, or characteristics described in conjunction with that embodiment or example are included in at least one embodiment or example of the present invention. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

[0053] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to the embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the claims and their equivalents.

Claims

1. A sheath-feeding system that is easy to push, characterized in that: The sheath introduction system includes: The sheath comprises a sheath seat, a sheath tube, an irrigation connector and an aspiration connector, wherein the sheath seat is arranged at the proximal end of the sheath tube, the irrigation connector and the aspiration connector are arranged on the sheath seat, the sheath tube defines a channel for external instruments to pass through, and the sheath tube is suitable for entering a human body cavity; A resistance detection member is provided on the sheath to detect the movement resistance of the sheath tube entering the human body cavity and to provide feedback on the resistance value; A pressure detection element, which is used to detect the pressure in the human body cavity and is suitable for being arranged on the endoscope or the sheath; An irrigation device is connected to the irrigation connector to deliver irrigation liquid into the human body cavity through the sheath channel; a controller, which is in communication with the pressure detection element, the resistance detection element, and the perfusion device; The controller is configured to execute a sheathing method, the sheathing method comprising the following steps: Step 1) Preset the maximum warning resistance value and the maximum warning pressure value. The resistance detection component is used to detect the resistance of the sheath entering the lumen, and the pressure detection component is used to detect the pressure in the lumen in real time. Step 2) During the process of pushing the sheath into the human body cavity, when the resistance detection component detects that the pushing resistance reaches the maximum warning resistance value, the perfusion device starts the perfusion mode to send the perfusion liquid into the cavity to expand the cavity; There are two situations here: The first scenario: if the sheath insertion resistance decreases after the lumen is expanded, the sheath tube is continued to be pushed. This scenario indicates that the large sheath insertion resistance is caused by lumen stenosis. In the second case, if after the lumen is expanded by perfusion, the pressure in the lumen reaches the maximum warning pressure value, but the sheath advancement resistance still exceeds the maximum warning resistance value, it proves that the volume of the perfusion expansion lumen is limited and the sheath is still difficult to advance. In this case, consider replacing the sheath with a smaller size. Step 3) Push the small-sized sheath into the lumen and repeat the sheath pushing method of step 2). If the sheath insertion resistance of the small-sized sheath still exceeds the maximum warning resistance value, it is determined that the lumen is blocked.

2. The sheath insertion system according to claim 1, characterized in that The sheath insertion system further includes a suction device. The controller is in communication with the pressure detection component, the resistance detection component, the irrigation device and the suction device. The irrigation device cooperates with the suction device to maintain a suitable pressure in the cavity.

3. The sheath insertion system according to claim 2, characterized in that: The controller is configured to execute a sheathing method, the sheathing method comprising the following steps: Step 1): Preset the maximum warning resistance value, maximum warning pressure value, minimum warning pressure value, and pressure control value. The controller controls the perfusion device to deliver the perfusion liquid into the body cavity and can control the suction device to extract the liquid in the body cavity: Step 2): During the sheath advancement process, when the resistance detection component detects that the resistance reaches the highest warning resistance value, the perfusion device turns on the perfusion mode to expand the lumen. When the pressure in the lumen reaches the highest warning pressure value, the perfusion device stops perfusion and continues to push the sheath tube. If the sheath advancement resistance decreases, the sheath will continue to be advanced. When the sheath tube reaches the target position, the suction device turns on the suction mode to reduce the pressure in the lumen. If the resistance to sheath entry does not decrease after the perfusion device is filled with liquid, the pressure in the cavity should be regulated to the control value by coordinating the perfusion device and the suction device, and a smaller sheath should be replaced. Step 3) After replacing the small-sized sheath, reinsert the sheath. If the sheath insertion is smooth, it is considered to be a case of local lumen stenosis. If the resistance reaches the maximum warning resistance value when reinsert the sheath, repeat the sheath pushing method in step 2). If the sheath insertion resistance does not decrease after the perfusion device is perfused with liquid and still exceeds the maximum warning resistance value, it is determined to be a case of lumen obstruction.

4. The sheath insertion system according to claim 2, characterized in that: The sheath advancement system is configured with a variety of sheath advancement modes. Different sheath advancement modes have different maximum warning resistance values. The sheath advancement modes include at least a high-resistance sheath advancement mode and a low-resistance sheath advancement mode. The appropriate sheath advancement mode is selected according to the diameter, curvature and elastic toughness of the sheath advancement path.

5. The sheath insertion system according to claim 3, characterized in that: The sheath insertion method includes a pressure control method in the cavity, which includes: adjusting the perfusion and suction parameters according to the real-time monitored pressure value and the data change trend of the pressure value, so that the current cavity pressure is balanced at the pressure control value, and a balanced state of perfusion and suction is achieved. The perfusion parameters include the perfusion flow gear, and the suction parameters include the opening of the pressure relief valve and the suction pressure threshold. The suction pressure threshold is the suction pressure threshold of the suction container preset by the controller, and the start and stop of the suction pump are controlled by setting the suction pressure threshold.

6. The sheath insertion system according to claim 1, characterized in that: The sheath defines a pressure measuring channel extending from the proximal end toward the distal end. The distal end of the pressure measuring channel forms at least one pressure measuring port for sensing the pressure in the cavity. A pressure detecting component is provided on the pressure measuring channel or any path connected thereto.

7. The sheath insertion system according to claim 6, characterized in that: The sheath seat is provided with a pressure measuring interface communicated with the pressure measuring channel, and the pressure measuring interface is suitable for connecting with the pressure detecting element.

8. The sheath insertion system according to claim 4, characterized in that: If the sheath entry channel is a ureter with good elasticity and strong toughness, the high-resistance sheath entry mode is selected; for a ureter with poor elasticity, the low-resistance sheath entry mode is selected.

9. The sheath insertion system according to claim 4, characterized in that: If the sheath insertion channel has a large bend, select the low-resistance sheath insertion mode; if the sheath insertion channel has a small bend, select the high-resistance sheath insertion mode.

10. The sheath insertion system according to claim 4, characterized in that: If the diameter of the sheath insertion channel is large, select the high-resistance sheath insertion mode. If the sheath insertion channel is narrow, select the low-resistance sheath insertion mode.

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