Sheath entering system

Abstract

The invention provides a sheath entry system convenient to push. The sheath entry system 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 filling device; the controller is configured to execute a sheath entering method, and the sheath entering method comprises the following steps that in the process that the sheath tube is pushed into a human body cavity, when the resistance detection piece detects that the pushing resistance reaches the highest warning resistance value, the perfusion device starts a perfusion mode to send perfusion liquid into the cavity so as to expand the cavity, and if the cavity is expanded, the sheath tube enters the sheath tube. If the sheath entering resistance is reduced, the sheath tube continues to be pushed, and if the cavity is expanded through perfusion liquid, the pressure in the cavity reaches the highest warning pressure value, and the sheath entering resistance still exceeds the highest warning resistance value, it is proved that the volume of the perfusion expansion cavity is limited, and a small-specification sheath is replaced; and the small-specification sheath is pushed to enter the cavity, and if the sheath entering resistance of the small-specification sheath still exceeds the highest warning resistance value, it is judged that the cavity is blocked.

Description

Technical Field

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

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

[0003] The present invention provides a sheath-introduction system that is easy to push, and the sheath-introduction system comprises:

[0004] The sheath comprises a sheath seat, a sheath tube, an infusion joint and an aspiration joint, wherein the sheath seat is arranged at the proximal end of the sheath tube, the infusion joint and the aspiration joint 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, which is arranged on the sheath to detect the movement resistance of the sheath tube entering the human body cavity and to feed back the resistance value;

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

[0007] An infusion device is connected to the infusion joint to deliver the infusion 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 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 cavity, and the pressure detection component is used to detect the pressure in the cavity in real time;

[0011] Step 2) During the process of pushing the sheath tube into the human body cavity, when the resistance detection component detects that the pushing resistance reaches the highest 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 situation: if the sheath push resistance decreases after the cavity is expanded, the sheath tube 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, if the cavity is expanded by perfusing the liquid, the pressure in the cavity reaches the highest warning pressure value, and the sheath push resistance still exceeds the highest warning resistance value, it proves that the volume of the perfusion expansion cavity is limited, and the sheath tube is still difficult to move forward. At this time, consider replacing a small-sized sheath;

[0012] Step 3) Push the small-sized sheath into the cavity, 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 cavity is blocked.

[0013] In some embodiments, the sheath advancement system further comprises a suction device, the controller is communicatively connected with the pressure detection member, the resistance detection member, the perfusion device and the suction device, and the perfusion 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): Preset the maximum warning resistance value, the maximum warning pressure value, the minimum warning pressure value, and the 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:

[0016] Step 2): During the sheath insertion 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 cavity. When the pressure in the cavity reaches the highest 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.

[0017] If the resistance to the sheath does not decrease after the perfusion device is perfused with liquid, the pressure in the cavity is regulated to the pressure control value by coordinating the perfusion device with the suction device, and a small-sized sheath is 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 reinserting the sheath, repeat the sheath pushing method of step 2). If the sheath insertion resistance does not decrease after the perfusion device perfuses the 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 the balance state of perfusion and suction is achieved, the perfusion parameters include the perfusion flow gear, 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 connected to the pressure measuring channel, and the pressure measuring interface is suitable for connecting to the pressure detecting element.

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

[0026] The present invention provides a sheath insertion method which simplifies the operation of physicians during surgery through comprehensive regulation of 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] Figure 1 A schematic diagram of the structure of the sheath insertion system provided by the present invention;

[0028] Figure 2 A schematic diagram of the structure of the sheath provided by the present invention;

[0029] Figure 3 A structural cross-sectional view 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", "rear", "upper", "lower" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation of the present invention. In the present application, the proximal end should be interpreted as the part close to the operator (doctor), and the distal end should be understood as the part 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 of 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 the specific circumstances.

[0033] See also Figure 1-Figure 3The present invention provides a sheath-introduction system that is easy to push. The sheath-introduction system includes a sheath and a perfusion and suction system. The perfusion and suction system includes a perfusion device, a suction device and a controller. The sheath includes a sheath seat 2, a sheath tube 1, a perfusion joint 21, a suction joint 22 and a resistance detection member 6. The sheath seat 2 is arranged at the proximal end of the sheath tube 1. The sheath seat 2 has a perfusion joint 21 and a suction joint 22. The suction joint 22 is suitable for connecting with a suction device. The perfusion joint 21 is suitable for connecting with the perfusion device. The perfusion device perfuses liquid into the body cavity through the perfusion 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 member 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 member 6 is installed on the sheath tube 1 to monitor the contact force between the sheath tube 1 and the cavity wall during the pushing process. The resistance detection can be achieved in a variety of ways, such as using a strain gauge, a pressure sensor or a micro force sensor to sense the change in external resistance during the movement of the sheath tube into the cavity, and can provide real-time feedback to the operator on the state of the cavity, reducing the risk of blind operation and avoiding cavity damage that may be caused by excessive resistance. If the resistance is too large, the doctor can replace a small-sized sheath or expand the cavity by injecting 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 to force 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 arranged on the endoscope or the 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 with the pressure detection component, the resistance detection component and the perfusion device. Further, 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 arranged on the pressure measuring channel or any path connected thereto. Exemplarily, the pressure sensor is arranged 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 connecting with the pressure detection component 5.

[0035] In one embodiment of the present invention, the perfusion device includes a liquid inlet tube 10, a liquid storage bag 11 and a perfusion pump. The perfusion pump is connected to the liquid storage bag 11 through the liquid inlet tube 10; the perfusion pump is connected to the perfusion 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 perfusion device perfuses the liquid in 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 is integrated with the diaphragm pump and the controller on the same main control machine 100. The pressure detection device 5 and the resistance detection device 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 realized 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 level of perfusion and suction can be adjusted in real time through the cavity pressure feedback by the pressure detection device. For example, if the pressure detection device 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 relying on resistance detection is provided, and the sheath insertion method comprises the following steps:

[0037] Step 1): Preset the highest warning resistance value, the lowest warning resistance value, and the highest 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 entry resistance decreases after the cavity is expanded, the sheath continues to be pushed. This situation indicates that the large sheath entry resistance here is due to the large sheath entry resistance caused by the stenosis of the cavity. In the second situation, if after the cavity is expanded by perfusing the liquid, the pressure in the cavity reaches the maximum warning pressure value, and the sheath entry resistance still exceeds the maximum warning resistance value, it proves that the volume of the perfused and expanded 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, 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 visual devices such as endoscopes. 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 the cavity damage caused by excessive resistance during the sheath insertion process, and improves the safety of the operation. It is worth noting that when the method of expanding the cavity through 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 insertion system will prompt to replace the small-sized sheath for further operation. This flexible multi-specification sheath switching mechanism helps to continue the operation under complex cavity conditions and avoids the interruption of operation 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 basis for judgment 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 cooperates with the suction device 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): preset the highest warning resistance value, the highest warning pressure value, the lowest warning pressure value, the pressure control value, and the perfusion flow rate gear, and 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 ideal pressure value or pressure range in the preset 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 insertion 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 cavity. When the pressure in the cavity reaches the highest 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.

[0043] If the resistance to sheath insertion does not decrease after the perfusion device is perfused 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 further and a small-sized 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 has reached 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, thereby achieving a balanced state of perfusion and suction, and can effectively avoid excessive expansion or collapse of the cavity, thereby maintaining the stability of the cavity and ensuring smooth operation. After replacing a 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 to prevent the doctor from continuing to push and causing damage to the cavity. 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 lumen is expanded by perfusion to achieve the reduction of 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 lumen. 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 pressure in the lumen is balanced at the pressure control value to achieve a balanced state of perfusion and suction. The perfusion parameters include the perfusion flow rate 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 pump is started and stopped by setting the suction pressure threshold. The pressure control method can select the pressure control method announced in CN116983498B. By optimizing the pressure control, it is ensured that the lumen expansion will not cause damage to the lumen.

[0047] In a specific embodiment of the present invention, the sheath advancement system is configured with a plurality of 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, and the maximum warning resistance value of the high-resistance sheath advancement mode is greater than the maximum warning resistance value of the low-resistance sheath advancement mode. The doctor selects a suitable sheath advancement mode according to the diameter, curvature and elastic toughness of the sheath advancement path. In this way, the system can accurately control the thrust of the sheath tube, ensure the implementation of a suitable thrust range (such as 0.5-5N) under different cavity conditions, and avoid using excessive thrust to cause ureteral damage, tearing or perforation. Accurate force control and regulation greatly reduce the operation risk, and is particularly suitable for the ureter, a thin cavity structure that is easily damaged. A variety of sheath advancement modes can be selected, such as a high-resistance sheath advancement mode, a medium-resistance sheath advancement mode, and a low-resistance sheath advancement mode. Different sheath advancement modes correspond to different maximum warning resistance values, that is, to different thrusts.

[0048] The relationship between the thrust force and the sheath cavity is explained in detail below.

[0049] If the sheath passage is a ureter with good elasticity and strong toughness, the high-resistance sheath passage mode is selected; if the sheath passage is a ureter with poor elasticity, the low-resistance sheath passage mode is selected. If there is a large bend in the sheath passage, the low-resistance sheath passage mode is selected; if the curvature of the sheath passage is small, the high-resistance sheath passage mode is selected. If the diameter of the sheath passage is large, the high-resistance sheath passage mode is selected; if the sheath passage is narrow, the low-resistance sheath passage mode is selected. In some examples, the sheath passage is a ureter, and the sheath passage system presets high-resistance and low-resistance sheath passage modes according to the characteristics of the ureter such as diameter, curvature and elasticity to ensure that the thrust meets the requirements of different lumen conditions. For example, a high-resistance sheath passage mode can be used for a ureter with a larger diameter or a straighter diameter, while a low-resistance sheath passage mode can be used for a ureter with a smaller diameter or a larger curvature. Doctors flexibly select the appropriate sheath passage mode according to individual anatomical structures, that is, select the appropriate push force, which reduces the risk of lumen damage and ensures 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 3-4mm, but there are individual differences. If the ureter is thin, a smaller thrust is required when pushing the ureteroscope to avoid ureteral damage, and the thrust range is controlled at about 0.5-2N; if the ureter is relatively thick, it may be able to withstand a slightly larger thrust, but it should not usually exceed 5N. 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 thrust is required to avoid damage when pushing the sheath, and the thrust range is controlled at about 0.5-1.5N; and the relatively straight part of the ureter can appropriately increase the thrust, and the thrust is controlled to not exceed 3N. Elasticity and toughness of the ureter: The elasticity and toughness of the ureters of different individuals are different. Ureters with good elasticity and toughness can withstand relatively large thrusts, and the thrust range is controlled at 2-5N; while for ureters with poor elasticity, the thrust range is controlled at 1-3N. Excessive thrust can easily cause ureteral tearing or perforation.

[0050] Exemplarily, the present invention provides a method for pushing a sheath into a urinary cavity. During the process of pushing the sheath into the urinary cavity, the resistance encountered by the sheath push will vary with the size and stenosis of the urinary cavity. During the pushing process, the urinary cavity squeezes the pressure sensor on the sheath, and the data of the pressure sensor will be fed back to the pressure monitoring instrument. By analyzing the pressure, the resistance of pushing the sheath is judged. When the pushing resistance is too large, the system will issue an instruction, and the perfusion device will start to perfuse to fill the urinary cavity. When the urinary cavity reaches a certain pressure, the blocked urinary cavity will be expanded. Then, while the perfusion suction system continues to perfuse, the doctor pushes the sheath into the expanded urinary cavity. When the pressure in the urinary cavity is too high, the suction device starts to suck the liquid in the urinary cavity out of the body. The system works cyclically according to the pressure detection value of the perfusion suction system to control the pressure of the urinary cavity to be within the pressure control value range until the sheath reaches the target position of the urinary cavity smoothly. The working mode of this system can reduce the damage to the patient's urinary cavity during the sheath delivery process.

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

[0052] In the description of this specification, the description with reference to the terms "one embodiment", "some embodiments", "specific examples", or "some examples" means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representation of the above terms does not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner.

[0053] Although the 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 present invention, and that the scope of the present invention is defined by the claims and their equivalents.

Claims

1. A sheath-introduction system that is easy to push, characterized in that: The sheath introduction system includes: The sheath comprises a sheath seat, a sheath tube, an infusion joint and an aspiration joint, wherein the sheath seat is arranged at the proximal end of the sheath tube, the infusion joint and the aspiration joint 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, which is arranged on the sheath to detect the movement resistance of the sheath tube entering the human body cavity and to feed back the resistance value; A pressure detection element, which is used to detect the pressure in a human body cavity and is suitable for being arranged on an endoscope or a sheath; An infusion device is connected to the infusion joint to deliver the infusion 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 cavity, and the pressure detection component is used to detect the pressure in the cavity in real time; Step 2) During the process of pushing the sheath tube into the human body cavity, when the resistance detection component detects that the pushing resistance reaches the highest 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 situation: if the sheath push resistance decreases after the cavity is expanded, the sheath tube 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, if the cavity is expanded by perfusing the liquid, the pressure in the cavity reaches the highest warning pressure value, and the sheath push resistance still exceeds the highest warning resistance value, it proves that the volume of the perfusion expansion cavity is limited, and the sheath tube is still difficult to move forward. At this time, consider replacing a small-sized sheath; Step 3) Push the small-sized sheath into the cavity, 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 cavity is blocked.

2. The sheath insertion system according to claim 1, characterized in that: The sheath advancement system also 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, the maximum warning pressure value, the minimum warning pressure value, and the 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 insertion 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 cavity. When the pressure in the cavity reaches the highest 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 resistance to the sheath does not decrease after the perfusion device is perfused with liquid, the pressure in the cavity is regulated to the pressure control value by coordinating the perfusion device with the suction device, and a small-sized sheath is 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 stenosis of the lumen. If the resistance reaches the maximum warning resistance value when reinserting the sheath, repeat the sheath pushing method of step 2). If the sheath insertion resistance does not decrease after the perfusion device perfuses the 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 2, 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 the 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 introduction system according to claim 1, characterized in that: The sheath tube 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.

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 detection component.

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 introduction 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 introduction 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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