Introducer sheath and perfusion and suction system

The guide sheath design enables precise control of irrigation and aspiration during ureteroscopic lithotripsy, solving the problem of inaccurate pressure control within the renal pelvis and improving the safety and efficiency of the procedure.

WO2026000598A1PCT designated stage Publication Date: 2026-01-02ZHEJIANG YIGAO MEDICAL TECH CO LTD
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Patent Information

Application Number
PCT/CN2024/115815
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-06-28
Filing Date
2024-08-30
Publication Date
2026-01-02

AI Technical Summary

Technical Problem

In existing ureteroscopic lithotripsy procedures, the irrigation fluid causes an increase in intrarenal pelvic pressure, leading to an infection risk. Furthermore, the pressure measurement accuracy and ease of operation are insufficient, making it difficult to control intrarenal pelvic pressure in real time and accurately.

Method used

A guide sheath was designed, including a sheath tube, a handle, a seal, a PCB board, and a pressure sensor. Through precise pressure monitoring and control, an infusion and aspiration system was integrated to achieve an efficient discharge path and pressure relief mechanism, thereby optimizing pressure measurement accuracy and ease of operation.

Benefits of technology

It improved the efficiency of stone removal, enhanced pressure measurement accuracy and ease of operation, reduced the risk of infection, and ensured the safety and efficiency of the surgery.

✦ Generated by Eureka AI based on patent content.

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  • Figure CN2024115815_02012026_PF_FP_ABST
    Figure CN2024115815_02012026_PF_FP_ABST
Patent Text Reader

Abstract

A perfusion and suction system and an introducer sheath (10) thereof. The introducer sheath (10) comprises a sheath tube (102) and a handle. The handle is connected to the proximal end of the sheath tube (102), such that the handle can remain outside the body of a patient. The handle comprises a handle main body (101), and a first connecting member (120) and a pressure regulating member (18) that are arranged on the handle main body (101). The handle main body (101) extends in a direction consistent with the axis of the sheath tube (102) to facilitate gripping by a user. The handle main body (101) defines a port (108) in communication with a first lumen (104), so that a medical instrument can enter the first lumen (104) by means of the port (108). The first connecting member (120) has a first channel, and the first channel is in communication with the first lumen (104) to form a liquid discharge path. The first connecting member (120) is adapted to be connected to a negative pressure device, so that a liquid medium in the body of a patient is discharged out of the body by means of the liquid discharge path. The pressure regulating member (18) is in communication with the first lumen (1804) and is arranged away from the liquid discharge path, so as not to contact the liquid when regulating the pressure of the liquid discharge path.
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Description

Guide sheath and perfusion suction system

[0001] TECHNICAL FIELD

[0002] The present application relates to a perfusion suction system and a guide sheath used in ureteroscopy. BACKGROUND

[0003] In conventional ureteroscopy, the powder of the stone and the hematuria in the renal pelvis can cause blurred vision, and the irrigation fluid needs to be perfused to keep the vision clear, but at the same time, the pressure in the renal pelvis will be significantly increased due to too fast perfusion and poor backflow, causing infection urine, bacteria and endotoxin to enter the blood and lymph circulation, resulting in fever, systemic inflammatory response syndrome and even fatal urosepsis in patients after surgery. In order to prevent serious infection caused by high pressure in the renal pelvis during ureteroscopy, it is necessary to control the pressure in the renal pelvis within a safe range during surgery, and further to adjust the perfusion speed and / or the suction value according to the feedback of the pressure in the renal pelvis. Whether the pressure measuring method can accurately measure the pressure in the renal pelvis in real time is the cornerstone to ensure that the pressure control system has good performance and the operation is safe.

[0004] The ureter pressure measuring sheath 10 is mainly used in the treatment of ureteral stenosis, adhesion, obstruction, obstruction and stone in clinical practice, and is used to establish a surgical channel for introducing an endoscope 20, a laser fiber, a stone removal instrument or an operating cable. At the same time, in order to keep the vision clear during the existing urological surgery, irrigation fluid is needed, but the pressure in the renal pelvis will be significantly increased due to too fast perfusion and poor backflow. In order to prevent a series of complications such as fever and renal pelvis rupture caused by changes in the pressure in the renal pelvis, it is necessary to control the pressure in the renal pelvis within a safe range during surgery.

[0005] The existing flexible pressure measuring sheath retains a pressure measuring lumen, the sensor and the pressure measuring control module are placed on the main control machine or the main control machine pipeline, then connected through the connecting pipeline and the pressure measuring lumen of the pressure measuring sheath, and then the pressure is transmitted to the sensor, however, the pressure measuring accuracy of this structure is greatly affected by the pipeline, the pressure measuring accuracy is poor, and the operation keys are divided on the main machine, which is not convenient for doctors to control and operate, and it is difficult to control the perfusion and suction process in the process of focusing on stone crushing and stone cleaning. In addition, some schemes also install a pressure sensor on the pressure measuring sheath or the endoscope, and the pressure measuring control module is on the main machine or the main machine pipeline, and the sensor and the pressure measuring control module are connected through a cable. This structure has poor controllability, and the pressure measuring accuracy cannot be completely guaranteed. SUMMARY

[0006] The present application provides a guide sheath, which comprises

[0007] a sheath tube sized and shaped to access a target region within a body through a body lumen, the sheath tube extending longitudinally from a proximal end to a distal end, the sheath tube defining at least a first lumen extending longitudinally from the proximal end to the distal end;

[0008] a handle connected to the proximal end of the sheath tube so that the handle can be held outside the body, the handle including a handle body extending in a direction coinciding with the axis of the sheath tube for user gripping, the handle body defining a port communicating with the first lumen for the medical instrument to access the first lumen, a first connector having a first passage communicating with the first lumen to constitute a drainage path, the first connector being adapted to be connected to a negative pressure device to drain the liquid medium in the body outside the body through the drainage path, a pressure regulator communicating with the first lumen and disposed away from the drainage path to not contact the liquid when adjusting the pressure of the drainage path;

[0009] a seal disposed at the port, the seal including a passage therethrough for the medical instrument to pass through to form a sealed cavity between the first lumen and the body.

[0010] In some embodiments, the guide sheath further includes

[0011] a PCB board mounted in the handle body, the PCB board being provided with at least one data terminal configured to be connected to an external perfusion and suction device to transmit signals;

[0012] an operation button disposed on the handle body and connected to the PCB board to control the operation state of the perfusion and suction.

[0013] In some embodiments, a pressure measuring lumen longitudinally extending from the proximal end towards the distal end is formed in the tube wall of the sheath tube, the pressure measuring lumen being provided with a pressure measuring port at the distal end for sensing the pressure of the liquid in the body, a pressure sensor being disposed on the pressure measuring lumen or any path communicating therewith, the pressure sensor being connected to the PCB board; preferably, the handle includes a second connector disposed on the handle body, the second connector having a second passage communicating with the pressure measuring lumen, the pressure sensor being disposed at the second passage to sense the pressure in the second passage.

[0014] In some embodiments, a liquid outlet is provided at the bottom end of the first lumen, the first connector is disposed below the handle body, and the axis of the first passage is perpendicular to the axis of the first lumen to constitute a straight drainage path.

[0015] In some embodiments, the bottom of the handle body is provided with a hand positioning part, the first connecting member is arranged on the bottom of the handle body, the second connecting member is arranged on the side wall of the handle, and the pressure regulating member and the operation button are located on the upper part of the handle.

[0016] In some embodiments, the handle comprises a third connecting member arranged on the handle body, and the sheath tube defines an auxiliary lumen extending from the proximal end to the distal end, and the third connecting member is in communication with the auxiliary lumen to form a liquid supplement channel.

[0017] In some embodiments, the sheath tube is sealingly connected with the handle body to form a calibration chamber in the handle body, the calibration chamber is in communication with the outside, and the PCB board and the pressure sensor are arranged in the calibration chamber, the pressure sensor is a gauge pressure sensor, the outer wall of the second channel is provided with a pressure measuring hole in communication with the calibration chamber, the gauge pressure sensor is located in the chamber, and at least the sensing film thereof is arranged at the pressure measuring hole to collect the pressure in the pressure measuring lumen, and the second channel has an opening in communication with the outside, and the opening can be opened or closed by a sealing part, and the calibration of the pressure sensor is realized by the cooperation of the opening and the calibration chamber.

[0018] In some embodiments, the pressure regulating member comprises a pressure relief valve arranged on the handle body, the handle body is provided with a pressure relief chamber in communication with the first lumen, and the pressure relief valve seals or opens the pressure relief chamber; preferably, the pressure relief valve comprises a pressing part, the pressing part is connected with a pressure relief hose, and the pressure relief hose is formed with an openable and closable valve.

[0019] In some embodiments, the second connecting member is configured to be connected with an external air inlet device to eliminate the water film tension of the pressure measuring lumen.

[0020] In some embodiments, an exhaust pipe in communication with the outside and the calibration chamber is arranged in the data connector to maintain the pressure stability in the handle body.

[0021] In some embodiments, the sealing member is connected at the proximal end of the sheath tube, the proximal end of the handle body is provided with a pressing member, the pressing member comprises a pressing part pressing above the sealing member and a rotating part rotatingly matched with the handle body, the sealing member is provided with a lower pressure relief hole, the pressing part is provided with an upper pressure relief hole, and the lower pressure relief hole and the upper pressure relief hole are communicated by rotating the rotating part to rotate the pressing part to realize pressure stabilization.

[0022] In some embodiments, the pressure measuring hole is in communication with the outside and / or the first lumen; preferably, the distal end of the pressure measuring lumen is located proximally to the distal end of the first lumen, and the distal end of the pressure measuring lumen is provided with a pressure measuring hole penetrating the outside and the first lumen.

[0023] In some embodiments, the pressure measuring tube cavity is distally provided with a pressure sensor, and a signal line is arranged in the pressure measuring tube cavity to transmit the pressure signal collected by the pressure sensor to the PCB board.

[0024] In some embodiments, at least the surface of the pressure measuring tube cavity in the distal cavity is coated with a hydrophilic or hydrophobic coating.

[0025] In some embodiments, a one-way valve is arranged on the second connecting piece to allow gas to enter the pressure measuring tube cavity from the outside only in one direction.

[0026] Another object of the present application is to provide a perfusion and suction system, which comprises a guide sheath as described above, an endoscope, which seals through the port of the handle body into the first lumen, and the gap between the first lumen and the endoscope discharges the body waste liquid; a perfusion device connected with the endoscope to send liquid medium into the body through the endoscope catheter; a suction device connected with the first connecting piece to generate negative pressure in the liquid discharge path to suck the waste liquid containing stones out of the body; and a master control machine connected with the perfusion device, the suction device and the PCB board to control the operation state of perfusion and suction.

[0027] The present application optimizes the performance of the perfusion and suction system by precise pressure monitoring and regulation, efficient discharge path, convenient pressure relief mechanism, multifunctional integrated handle design, efficient perfusion and suction system, precision and response speed, improves the efficiency of stone removal, pressure measurement accuracy and operation convenience.

[0028] Additional aspects and advantages of the present application will be partially given in the following description, partially will become obvious from the following description, or will be understood by the practice of the present application. BRIEF DESCRIPTION OF DRAWINGS

[0029] The above and / or additional aspects and advantages of the present application will become apparent and more readily appreciated from the following description, taken in conjunction with the following drawings, in which:

[0030] FIG. 1 is a structural schematic diagram of a perfusion system related to the pressure measuring sheath provided by the present application;

[0031] FIG. 2 is a schematic diagram of the principle of the pressure measuring sheath provided by the embodiment of the present application;

[0032] FIG. 3 is a structural schematic diagram of the pressure measuring sheath (cooperating with a dilator) provided by the present application;

[0033] FIG. 4 is a partial structural schematic diagram of the pressure measuring sheath (cooperating with a dilator) of the present application;

[0034] FIG. 5 is a structural split schematic diagram of the pressure measuring sheath (cooperating with a dilator) provided by the present application;

[0035] FIG. 6 is a structural cross-sectional view of the pressure measuring sheath provided by the present application;

[0036] Figure 7 is a structural side view of the pressure measuring sheath provided by the present application;

[0037] Figure 8 is a structural cross-sectional view of the pressure measuring sheath provided by the present application;

[0038] Figure 9 is a schematic view of the distal end of the pressure measuring sheath provided by the present application (with a dilator);

[0039] Figures 10-13 are schematic views of the structure of the pressure measuring port provided by the present application;

[0040] Figure 14 is a schematic view of the pressure measuring sheath provided by the present application being pumped with carbon dioxide;

[0041] Figures 15-16 are schematic views of the pressure detection principle of the pressure measuring sheath provided by the present application;

[0042] Figures 17-18 are structural cross-sectional views of the distal end of the pressure measuring sheath provided by the present application;

[0043] Figure 19 is a structural cross-sectional view of the cable provided by the present application;

[0044] Figure 20 is a schematic view of the structure of the sheath tube provided by the present application (with a sensor arranged at the distal end);

[0045] Figures 21-22 are schematic views of the operation of the pressure measuring sheath provided by the present application.

[0046] wherein,

[0047] 10 - pressure measuring sheath, 11 - data connector, 20 - endoscope, 200 - endoscope catheter

[0048] handle body, 102 - sheath tube, 103 - calibration chamber, 104 - first lumen, 105 - pressure measuring lumen, 106 - sealing member, 107 - pressure measuring port, 108 - port, 109 - finger ring, 120 - first connecting member, 121 - third connecting member, 122 - first sealing cap, 123 - auxiliary lumen, 124 - second connecting member, 125 - second sealing cap, 126 - pressure measuring hole, 127 - pressure relief chamber, 128 - pressing portion, 130 - pressure relief hole, 131 - switch, 132 - first connecting portion, 133 - pressing portion, 134 - rotating portion, 135 - limiting portion, 136 - flexible section, 138 - valve;

[0049] pressure sensor, 51 - PCB board, 52 - data connector, 521 - wire core, 522 - insulating outer covering, 53 - connector, 54 - operation button, 55 - exhaust pipe;

[0050] Dilator, 601-Second connecting part, 602-Dilator channel, 605-Groove, 603-Side hole, 604-Blocking part, 70-Connecting tube, 71-Carbon dioxide gas pump, 73-Hydrophilic or hydrophobic coating, 74-One-way valve;

[0051] Resistance bridge sensor, 81-Stainless steel sleeve, 82-Signal line;

[0052] 90-First negative pressure suction tube, 91-Suction container, 92-Second negative pressure suction tube, 93-Storage container, 94-Liquid inlet tube, 95-Liquid outlet tube, 100-Cabinet, 201-Endoscope cable, 202-Image processor. DETAILED DESCRIPTION

[0053] In the description of the present application, it should be understood that the terms "front", "back", "head", "tail", "far", "near", "axial" and "radial" indicate the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application.

[0054] In the description of the present application, it should be noted that unless otherwise specified and limited, the terms "mounting", "connection" should be understood broadly, for example, it can be mechanical connection or electrical connection, it can be the communication between two elements, it can be direct connection or indirect connection through intermediate medium, and those skilled in the art can understand the specific meaning of the above terms according to the specific circumstances.

[0055] Referring to FIG. 1, the present embodiment provides a perfusion suction system, which comprises a pressure measuring sheath 10, an endoscope 20, a perfusion device, a suction device, a pressure detecting component, and a main control machine, the endoscope 20 is inserted into the pressure measuring sheath 10 to observe the renal pelvis; the perfusion device uses a liquid medium to pressurize and expand the patient's cavity to form a visible interval, and can clean the impurities in the cavity, so that the doctor can observe through the endoscope 20 and the surgical field is clear; the suction device is used to suck the waste liquid in the patient's cavity out of the body, the pressure detecting component comprises a pressure sensor 50, which is used to detect the intracavity pressure in the renal pelvis, and the pressure detecting component, the perfusion device, the suction device and the main control machine are connected, that is, the main control machine controls the flow and pressure of the perfusion device and the suction device according to the pressure value output by the pressure sensor 50. Specifically, the perfusion device sends liquid into the cavity through the channel of the endoscope 20, the suction device is used to suck the waste liquid and stones in the cavity out through the negative pressure channel of the pressure measuring sheath 10, and the waste liquid and stones are collected into the suction container 91 through the negative pressure suction tube, the perfusion device and the suction device cooperate to keep the cavity at a suitable pressure. Exemplarily, the suction device comprises a diaphragm pump, a first negative pressure suction tube 90, a suction container 91 and a second negative pressure suction tube 92, the first negative pressure suction tube 90 connects the diaphragm pump and the suction container 91, and the second negative pressure suction tube 92 connects the suction container 91 and the liquid outlet of the pressure measuring sheath 10. The perfusion device comprises a liquid storage container 93 and a perfusion pump, the perfusion pump is connected with the liquid storage bag through a liquid inlet pipe 94, and the perfusion pump communicates with the liquid sending channel through a liquid outlet pipe 95. It can be understood that the liquid medium can enter the renal pelvis through the endoscope 20 or through the pressure measuring sheath 10. Optionally, the perfusion pump and the suction pump are installed on the same machine box 100 with the main control machine. Specifically, the perfusion pump is a peristaltic pump, and the suction pump is a diaphragm pump. In addition, the endoscope is connected with an image processor 202 through an endoscope cable 201, and the main control machine can be installed on the endoscope 20 or the image processor 202.

[0056] The following embodiments are based on the existing perfusion suction equipment, which aims to improve the efficiency of stone removal, the accuracy of pressure measurement and the convenience of operation by improving the sheath tube 102, the endoscope 20, the dilator 60 and the perfusion suction equipment. Embodiment 1

[0057] Referring to FIGS. 2-13, the pressure measuring sheath 10 provided in the present embodiment comprises a handle and an elongated sheath tube 102, the handle is gripped by the hand of an adult user, the user holds the handle with one hand to flexibly operate the pressure measuring sheath 10, the size and shape of the sheath tube 102 are suitable for entering the body through the body cavity, for example, the target area of the renal pelvis, and longitudinally extends from the proximal end to the distal end, the handle is connected to the proximal side of the sheath tube 102 so that the handle can be kept outside the body.

[0058] The sheath 102 defines at least a first lumen extending longitudinally from a proximal end to a distal end, and the handle comprises a handle body 101 and a first connector 120 disposed on the handle body 101, wherein the handle body 101 extends in a direction consistent with the axis of the sheath 102 to facilitate gripping by a user.

[0059] The handle body 101 defines a port 108 in communication with the first lumen 104, and a seal 106 is disposed at the port 108, the seal 106 comprising a passageway therethrough to form a sealed cavity between the first lumen 104 and the body through which the medical instrument passes.

[0060] The first connector 120 has a first passageway in communication with the first lumen to constitute a drainage path, and the first connector 120 is adapted to be connected to a negative pressure device to cause the liquid medium in the body to be drained out of the body through the drainage path. Exemplarily, the first connector 120 can be a luer connector or the like, which is connected to a suction device, and the waste liquid passes through the first lumen 104 and the first connector 120 to enter a collection container of the suction device.

[0061] Referring to FIG. 8, the handle body 101 is further provided with a pressure regulating member 18 for regulating the pressure of the first lumen. Thus, when the suction pressure is too large to cause the pressure in the renal pelvis to be too large and the organ to be sucked flat, etc., air is quickly introduced through the pressure regulating member 18 to quickly release the pressure to ensure the progress of the operation. In some preferred embodiments of the present application, the pressure regulating member 18 is in communication with the first lumen and is disposed away from the drainage path of the waste liquid, i.e., the pressure regulating member 18 is away from the drainage path of the waste liquid, so that the user will not be contaminated by the liquid when manually operating the pressure regulating member 18, achieving touch-free and aseptic operation. In addition, the pressure regulating member 18 is provided on the handle body 101, which is ingenious in that when the suction pressure is too large to cause the suction of the calculus to fail, the user needs to manually increase the suction force. Based on the pressure regulating member 18 provided in the present embodiment, the handle body 101 is held, and the pressure in the state chamber is quickly fluctuated between the pressure release and the negative pressure by repeatedly and quickly controlling the pressure regulating member 18. The repeated pressure fluctuation can produce a strong suction effect, making the calculus or other objects that are adsorbed or stuck more easily extracted. The rapidly changing pressure can produce sufficient impact force to help clear the blockage and ensure the smoothness of the suction passage. By controlling the pressure fluctuation, stronger suction force can be provided when needed, improving the efficiency and success rate of the operation.

[0062] In some embodiments of the present application, the pressure regulating member 18 comprises a pressure relief valve, the handle body is provided with a pressure relief cavity 127 in communication with the first lumen 104 of the sheath 102, and the handle body 101 is provided with a pressure relief valve for sealing or opening the pressure relief cavity 127. In some preferred embodiments of the present application, the pressure relief cavity 127 is arranged proximally of the liquid outlet, i.e. the path of the pressure relief cavity 127 is not the discharge path of the waste liquid, and it is away from the discharge path of the waste liquid. In this way, the waste liquid does not pass through the pressure relief cavity 127, and the user will not be contaminated by the liquid when manually operating the pressure relief valve, achieving touch-free and aseptic operation. In addition, the pressure relief cavity 127 and the pressure relief valve provided on the handle body 101 are ingenious in that when the suction pressure is too large to cause the suction of the calculus to fail, the user needs to manually increase the suction force. Based on the pressure relief cavity 127 and the pressure relief valve provided in the present embodiment, the handle body 101 is held, when the pressure relief valve is quickly opened, external air quickly enters the cavity, the pressure quickly rises, and the pressure relief effect is achieved; when the pressure relief valve is quickly closed, the suction device continues to work, the pressure in the cavity quickly drops, forming a negative pressure for suction; by repeatedly opening and closing the pressure relief valve, the pressure in the cavity will quickly fluctuate between pressure relief and negative pressure, and the repeated pressure fluctuations can produce a strong suction effect, making it easier to extract the calculus and other objects that are adsorbed or stuck. Illustratively, the pressure relief valve comprises a pressing portion 128, the pressing portion is connected with the pressure relief hose (pressure relief cavity 127), and a openable and closable valve 138 is formed on the pressure relief hose (pressure relief cavity 127). In this way, the user controls the opening degree and closing of the valve 138 by pressing the pressing portion 128. Illustratively, the pressing portion is connected with the pressure relief pipe, and pressing the pressing portion can adjust the opening degree and closing of the valve thereon, thereby adjusting the volume of external air entering the first lumen.

[0063] In one embodiment of the present application, the guide sheath further comprises a PCB board 51 and an operation button 54, the PCB board 51 is arranged in the handle body, at least one data connector 52 is arranged on the PCB board 51, the data connector 52 extends from the handle body 101, and the data connector 52 is adapted to be connected to an external infusion and suction device. Further, the handle body 101 is provided with an operation button 54, and the user controls the operation of infusion and suction by controlling the operation button 54. Specifically, the operation button 54 is located at the upper part of the handle body 101 for controlling the operation of infusion and suction, and the pressure regulating piece 18 is also arranged at the upper part. Thus, referring to FIGS. 21-22, the upper part of the handle body 101 constitutes an operation area, and the handle can realize operations such as infusion, suction, pressure relief, and increased suction force. All these operations can be completed by fingers, greatly simplifying the use process. The operation button 54 and the pressure regulating piece 18 are both arranged at the upper part, and during operation, the handle does not need to be frequently moved, but only needs to be operated by fingers at the upper part of the handle body 101. This reduces the moving range of the hand and improves the operation efficiency. Compared with the traditional design which needs to control multiple devices at the same time, the present application integrates multiple control functions into one. The doctor no longer needs to switch or coordinate multiple devices, but only needs to operate one handle to complete multiple functions, which reduces the complexity of operation.

[0064] The PCB board 51 is arranged at the middle position of the handle body 101, which optimizes the internal space layout and makes the shape and weight distribution of the handle body 101 more reasonable. The handle body 101 is designed more in line with ergonomics, increasing the comfort of use. In some examples of the present application, the bottom of the handle body 101 is provided with a finger ring 109, so that the operation surface is located at the top surface of the handle body 101. Such a design is in line with ergonomics, ensuring that the user can maintain a natural and comfortable holding posture during operation. The design of the finger ring 109 provides an additional support point, helping the user to hold the handle more stably and reducing the fatigue of the hand muscles. Due to the presence of the finger ring 109, the user can pass a finger through the finger ring 109, which can not only hold the handle stably, but also use other fingers flexibly for operation. The operation surface at the top of the handle body 101 is more convenient for fingers to touch, and the operation is more simple and convenient. The arrangement of the finger ring 109 makes the center of gravity of the handle more stable, and the weight can be more evenly distributed when holding the handle, improving the comfort of operation. The finger ring 109 makes the handle more stable, and the handle is not easy to slide or rotate during operation, thereby improving the accuracy and control force of operation. In summary, the design of the finger ring 109 makes the handle body 101 more in line with the user's usage habits and needs, especially in scenarios that require long-term holding and fine operation, significantly improving the user experience.

[0065] In the embodiment of the present application, the bottom end of the sheath tube 102 is provided with a liquid outlet, where the bottom end refers to the end facing the ground, i.e. the design of the bottom end liquid outlet utilizes gravity to make the waste liquid and stones flow downward, thereby enhancing the discharge efficiency. One end of the first connecting member 120 is arranged at the liquid outlet, and the other end extends out of the handle main body 101. The first connecting member defines a first channel axis perpendicular to the axis of the sheath tube 102. In this way, compared with discharging the waste liquid through the inclined side arm extending from the sheath tube 102, the present application forms a straight discharge path for discharging the waste liquid, which directly flows into the first connecting member 120 through the bottom end of the sheath tube 102. The straight path reduces the resistance encountered by the liquid and stones in the channel, thereby reducing the risk of blockage. Since the first connecting member 120 is directly connected with the liquid outlet without a bent pipeline, the waste liquid and stones do not need to change the flow direction when being discharged. This design significantly reduces the probability of retention and jamming of stones in the pipeline. In addition, the first connecting member is arranged below the handle main body 101 instead of the side, so that the operation of the doctor is not disturbed by the negative pressure suction device, further improving the smoothness and accuracy of the operation.

[0066] In the embodiment, the handle main body 101 is provided with a first connecting part 132 at the port 108, which is suitable for detachable connection with the dilator 60. The dilator 60 has a hand-held part and an elongated conduit. The first connecting part 132 is suitable for detachable connection with a second connecting part 601 of the hand-held part of the dilator 60, and specifically, the first connecting part 132 is snap-connected with the second connecting part 601. A rubber sealing ring (106) is connected with the elongated sheath tube, and is located in the handle main body 101. The rubber sealing ring is connected with the proximal end of the sheath tube, and is used for sealing penetration of the elongated dilator 60 or the conduit of the endoscope 20. Specifically, the handle main body 101 is provided with a pressing member, which includes a pressing part 133 pressed above a rubber valve and a rotating part 134 rotationally matched with the handle main body 101. The rubber sealing ring is provided with a lower pressure relief hole 130, and the pressing cover is provided with an upper pressure relief hole 130. The pressing cover is rotated by rotating the ring to make the lower pressure relief hole 130 communicate with the upper pressure relief hole 130, thereby achieving pressure stabilization.

[0067] In addition, the handle main body 101 is further provided with a limiting part 135 for preventing the dilator 60 from being pulled out, so as to limit rotation of the dilator 60 during cooperation of the dilator 60 with the sheath, facilitate operation, and improve efficiency.

[0068] In an example of the present application, the distal end of the sheath tube 102 is a flexible section 136 that can be bent. The endoscope 20 includes an operation part and a bending part, and the operation part can drive the bending part to bend. The endoscope 20 is inserted into the sheath tube 102, the bending part is accommodated in the flexible section 136, and the bending part can drive the flexible section 136 to bend. Example 2

[0069] In addition to the embodiment 1, the present application further provides a pressure measuring sheath for detecting the pressure in the body, such as the pressure in the renal pelvis, wherein a pressure measuring lumen 105 is formed in the tube wall of the sheath tube and extends longitudinally from the proximal end to the distal end, wherein the pressure measuring lumen 105 is arranged side by side with the first lumen 104, and a pressure measuring port is arranged at the distal end of the pressure measuring lumen 105 for sensing the pressure of the liquid in the body, and the handle comprises a second connector 124 arranged on the handle body, wherein the second connector 124 has a second channel communicating with the pressure measuring lumen 105, and a pressure sensor is arranged in the pressure measuring lumen 105, the second channel or any path communicating therewith, which can collect the pressure data of the pressure measuring lumen. For example, the pressure sensor 50 can be arranged at the distal end of the endoscope 20, the distal end of the pressure measuring sheath 10, the pressure measuring lumen 105 in the pressure measuring sheath 10, or any position in the pressure measuring path communicating with the pressure measuring lumen 105, such as an external device, and the position includes but is not limited to the second connector 124 communicating with the pressure measuring lumen 105.

[0070] Further, in the present embodiment, the pressure sensor 50 is arranged inside or outside the second channel. In the present embodiment, the outer wall of the second channel is provided with a pressure measuring hole 126, and the pressure sensor 50 is arranged inside the handle body, and at least the sensing part thereof is arranged at the pressure measuring hole 126 to sense the pressure of the pressure measuring lumen 105. It almost does not occupy the space of the second channel, and the second channel 124 can also be used as an auxiliary lumen, avoiding resource occupation by other instruments. It can be understood that the detection signal of the pressure sensor 50 can be connected to an external device through a connecting line for signal transmission and processing.

[0071] In some embodiments of the present application, the pressure sensor 50 is a gauge pressure sensor, the sheath tube 102 and the handle body 101 are sealingly connected to form a calibration chamber 103 in the handle body, the calibration chamber 103 is open to the outside for calibration and adjustment of the pressure sensor 50, the PCB board 51 and the pressure sensor 50 are arranged in the calibration chamber 103, the outer wall of the second channel is provided with a pressure measuring hole 126 communicating with the calibration chamber, the gauge pressure sensor is arranged in the chamber 103, and at least the sensing film thereof is arranged at the pressure measuring hole 126 to collect the pressure in the pressure measuring lumen, and the second channel has an opening which can be open or closed by a sealing part such as a second sealing cap 125, and the calibration of the pressure sensor 50 is realized by the opening and the calibration chamber 103.

[0072] Specifically, the working principle of the gauge pressure sensor is to determine the pressure value by measuring the pressure change of the sensor sensing film caused by the fluid or gas, and then compare this value with the ambient pressure to obtain the relative pressure value. If the pressure at the measurement point is higher than the atmospheric pressure, the sensor outputs a positive value; if it is lower than the atmospheric pressure, it outputs a negative value or zero value. When the pressure sensing sheath does not enter the body, the pressure sensing port 107 at the distal end of the pressure sensing sheath 10 is in communication with the calibration chamber 103, which realizes the calibration of the gauge pressure sensor. When the pressure sensing sheath enters the body, the second sealing cap 125 is opened, the second channel is open and in communication with the outside, at this time, in cooperation with the calibration chamber 103, the calibration of the gauge pressure sensor is realized. In addition, the gauge pressure sensor is installed in the handle main body 101, compared with being installed in the external setting such as the main control machine, it is set at the handle position, reduces the volume of the pressure sensing cavity, quickly and accurately responds to pressure changes, avoids signal attenuation and lag in a large space, and has higher precision.

[0073] In the present embodiment, the pressure sensor 50 is located in the handle main body 101 for electrical connection with the PCB board 51, and the data connector 52 is used to connect with external devices such as the main control machine, perfusion device, suction device, display device and the like to realize the transmission of pressure signal and the control of perfusion and suction operation state.

[0074] Please refer to FIG. 19, the data connector 52 (including wire core 521 and insulating outer covering 522) has an exhaust pipe 55 in communication with the outside and the handle main body 101, so as to realize the communication between the calibration chamber in the handle main body and the outside. In addition, since the pressing operation of the operation button or other operation of the handle will cause the pressure change in the sealed calibration chamber 103 in the handle main body 101, resulting in the basic deviation of the sensor, the design of the exhaust pipe eliminates the pressure fluctuation caused by the operation button 54, maintains the pressure stability in the handle main body 101, and avoids the pressure fluctuation in the handle main body 101 to reduce the pressure measurement accuracy of the pressure sensor 50. By reasonably arranging the pressure sensor 50 and its auxiliary equipment, combining the design of the sealed cavity and the exhaust pipe 55, the accurate pressure monitoring of the pressure sensing cavity 105 is realized, while the system stability and operation simplicity are ensured.

[0075] As described above, the distal end of the pressure measuring tube cavity 105 has a pressure measuring port 107, which is adapted to sense the pressure in the human body cavity and transmit it to the pressure measuring tube cavity. The pressure measuring port can be arranged in various ways: for example, referring to FIG. 10, the pressure measuring port 107 is in communication with the outside world and not in communication with the first tube cavity 104, i.e. the outer wall of the pressure measuring tube cavity 105 is opened to form the pressure measuring port. This type of pressure measuring port is in communication with the high pressure area in the cavity, has high measurement accuracy, and can accurately feedback the pressure in the cavity, but foreign matter can easily enter the pressure measuring tube cavity through the pressure measuring port on the outside, and the measurement accuracy will decrease after the pressure measuring tube cavity is blocked. In another embodiment, referring to FIG. 11, the pressure measuring port 107 is in communication with the first tube cavity 104 and not in communication with the outside world, i.e. the inner wall of the pressure measuring tube cavity 105 is opened to form the pressure measuring port. This type of pressure measuring port is in communication with the low pressure area in the cavity, and the measurement value will be relatively low compared to the overall pressure in the cavity, but the risk of foreign matter blocking the pressure measuring tube cavity is excluded. In another embodiment, referring to FIGS. 12 and 13, the pressure measuring port 107 is in communication with the outside world and the first tube cavity 104, i.e. the inner wall and the outer wall of the pressure measuring tube cavity 105 have openings, and in this embodiment, the opening in the inner wall and the opening in the outer wall are radially corresponding, i.e. the full type of pressure measuring port is in communication with the high pressure area and the low pressure area in the cavity at the same time, has high measurement accuracy, and can accurately feedback the pressure in the cavity, but also has the risk of blocking the tube. Alternatively, the opening in the inner wall and the opening in the outer wall are staggered, e.g. Z-shaped, i.e. the Z-shaped pressure measuring port is in communication with the high pressure area and the low pressure area in the cavity at the same time, has high measurement accuracy, and can accurately feedback the pressure in the cavity without the risk of blocking the tube. More preferably, the distal end of the pressure measuring tube cavity 105 is located proximally to the distal end of the first tube cavity, and the distal end of the pressure measuring tube cavity is provided with a pressure measuring port which is in communication with the outside world and the first tube cavity, i.e. the distal end of the pressure measuring tube cavity is not consistent with the distal end of the first tube cavity, and the pressure measuring port is in communication with the outside world and the first tube cavity.

[0076] In some embodiments of the present application, the proximal end of the sheath 102 is provided with a pressure relief hole 130 adapted to communicate with the outside world to facilitate the entry of air when the sheath 102 is placed into operation by an instrument or the like, causing pressure fluctuations, and the introduction of an appropriate amount of air through the opening of the pressure relief hole 130 to ensure the stability of the intracavity pressure, thus avoiding the pressure fluctuations caused by external operations and improving the accuracy of pressure measurement. It can be understood that the pressure relief hole 130 should be a small hole or a hole with valve control to introduce an appropriate amount of air to relieve the excessive internal pressure when necessary. In embodiments of the present application, the proximal end of the sheath 102 is provided with a seal 106, and the endoscope 20 or dilator 60 is sealed into the sheath 102. The seal 106 is provided with a pressure relief hole 130, and the pressure relief hole 130 is provided with an on-off switch to open or close the pressure relief hole 130, solving the influence of pressure fluctuations caused by the entry of an instrument or the like on pressure detection and achieving small-scale pressure relief. Alternatively, the sheath 102 includes a seal 106 and an elongated sheath, the seal 106 has a valve port, the seal 106 is connected to the proximal end of the sheath, and the valve port is provided for the elongated dilator 60 or endoscope 20 to be sealed through. The handle body 101 is provided with a pressing member at the proximal end, the pressing member includes a pressing portion 133 pressed above the seal 106 and a rotating portion 134 rotationally connected with the handle body 101, the seal 106 is provided with a lower pressure relief hole 130, and the pressing portion 133 is provided with an upper pressure relief hole 130. The rotating ring is rotated to drive the pressing portion 133 to rotate so that the lower pressure relief hole 130 communicates with the upper pressure relief hole 130 to achieve pressure stabilization. Embodiment 3

[0077] In some embodiments of the present application, the present application utilizes double-channel perfusion, and the flow of fluid between different channels is affected by the pressure difference. The liquid in the high-pressure area flows towards the low-pressure area, and the low-pressure area attracts more fluid. When the endoscope 20 enters the sheath 102, the waste liquid is sucked out of the body through the first lumen 104 of the sheath 102, and the liquid enters the body through the endoscope 20 conduit, one suction and one pumping. When the negative pressure suction pressure in the sheath 102 is very large, the pressure inside the sheath 102 is much lower than the pressure in the endoscope 20. Such a large pressure difference will cause more liquid to enter the body, which will cause the perfusion volume of the liquid to be too large and form a high perfusion pressure in the local area, resulting in difficulty in suctioning waste liquid such as stones.

[0078] Based on this, the handle body 101 of the embodiment is provided with a third connecting piece 121, which can be blocked by a first sealing cap 122. When liquid needs to be delivered, the first sealing cap 122 is opened, and when it is not needed, the first sealing cap 122 is closed to avoid the influence on the negative pressure. The sheath tube 102 has an auxiliary lumen 123 isolated from the first lumen 104 and the pressure measuring lumen 105, the third connecting piece 121 communicates with the auxiliary lumen 123, and the third connecting piece 121 and the auxiliary lumen 123 constitute a liquid inlet channel for the perfusion liquid medium to enter. In this way, the perfusion liquid enters the body through the third connecting piece 121 and the auxiliary lumen 123 to generate a small pressure fluctuation, so that a dynamic pressure environment is formed around the calculus to promote the loosening and movement of the calculus. The pressure fluctuation will periodically change the flow rate and direction of the liquid, thereby generating an impact force on the calculus, gradually reducing the adhesion and static friction between the calculus and the surrounding tissue. In addition, the introduction of the auxiliary lumen 123 provides more liquid inlet paths to ensure the stable supply of liquid medium and avoid the pressure instability caused by uneven liquid supply in a single channel. It solves the technical problem that the calculus is difficult to be effectively aspirated due to excessive perfusion pressure.

[0079] Optionally, the inner diameter of the second channel 124 and the third connecting piece 121 is greater than the inner diameter of the pressure measuring lumen 105 and the auxiliary lumen 123, so as to facilitate the entry of external instruments. Embodiment 4

[0080] The water film is easily formed at the pressure measuring port 107 at the distal end of the pressure measuring lumen 105. The formation of the water film makes it difficult to transmit the pressure signal to the pressure sensor 50 in time and accurately, and it is difficult to detect the pressure in real time. In addition, the water film tension causes the signal transmitted to the pressure sensor 50 to deviate from the actual pressure signal, thereby affecting the accuracy of the measurement. The pressure sensor 50 measures the pressure P=P3=P1+P2, P1 is the intracavity pressure, P2 is the water film tension, and P3 is the pressure in the pressure measuring lumen 105.

[0081] Based on this, in some embodiments of the application, the pressure measuring sheath 10 further comprises a tension eliminating mechanism to eliminate the influence of the water film on the intracavity pressure detection

[0082] As described above, please refer to FIG. 14, the handle body 101 is provided with a first connecting piece 124 in communication with the pressure measuring tube cavity 105, the first connecting piece 124 has an opening which can be sealed or opened by a second sealing cap 125, the first connecting piece 124 constitutes an air inlet tube for the high-frequency low-pressure gas from the outside to eliminate the water film; since the pressure sensor 50 does not occupy the space of the first connecting piece 124, the first connecting piece 124 can be used as other auxiliary tube cavities, improving the space utilization efficiency of the pressure measuring sheath 10. Effectively eliminating the interference of the water film on the signal transmission of the pressure sensor 50, ensuring the timely and accurate transmission of the pressure signal. For example, please refer to FIG. 15, open the second sealing cap 125 of the second channel 124, and deliver high-frequency micro-pressure gas such as carbon dioxide to the second channel 124 to break the water film tension balance of the liquid in the cavity at the distal end port 108 of the pressure measuring tube cavity 105, at this time the pressure measured by the pressure measuring module is P=P3+P4=P1+P2 (when the water film tension balance is broken P4=P2, P=P3=P1), wherein P1 is the cavity pressure, P2 is the water film tension, P3 is the pressure in the pressure measuring tube cavity 105, and P4 is the pressure of the high-frequency pulse carbon dioxide gas P4. For example, the second connecting piece 124 is connected to the carbon dioxide gas pump 71 interface through the connecting pipe 70.

[0083] In addition, a one-way valve 74 is arranged at the second connecting piece 124 to allow gas to be pumped into the pressure measuring tube cavity 105 from the outside only to remove the pressure accuracy decline caused by the water film tension. If the one-way valve 74 is not arranged, after the second sealing cap 125 is closed, foreign matter and water column will re-enter the pressure measuring tube cavity 105, and the second sealing cap 125 will press the air, causing the pressure difference in the pressure measuring tube cavity 105, combined with the influence of the water film, causing the pressure measuring accuracy to decline, and the use of the one-way valve 74 can prevent the water in the cavity from flowing backward into the pressure measuring tube cavity 105 after the inflation is completed, improving the pressure measuring accuracy.

[0084] In other embodiments, please refer to FIG. 16, the inner wall of the pressure measuring tube cavity 105 is provided with a hydrophilic or hydrophobic coating 73, and the water film tension can be considered as no contact to the pressure measuring tube cavity 105, at this time the pressure measured by the pressure measuring module is P=P3=P1. Reducing the retention of the water film, improving the self-cleaning ability and measurement accuracy of the pressure measuring tube cavity 105.

[0085] The present embodiment effectively eliminates the influence of the water film on pressure detection by introducing high-frequency low-pressure gas, coating treatment, one-way valve and other measures, significantly improving the measurement accuracy and stability of the system, Embodiment 5

[0086] When the pressure measuring sheath 10 (usually used in catheterization and other surgical operations) enters the body cavity, the negative pressure suction and perfusion have not yet started. At this time, the dilator 60 has been inserted into the pressure measuring sheath 10 to ensure that the pressure measuring sheath 10 can smoothly enter the body cavity. Since the dilator 60 occupies the first lumen 104 of the sheath tube 102, it is easy to cause foreign matter to enter the pressure measuring lumen 105, causing the pressure measuring lumen 105 to be blocked, and the pressure measuring accuracy to sharply decrease.

[0087] The dilator 60 is provided with a blocking part to limit the foreign matter from entering the pressure measuring lumen 105 through the pressure measuring port 107. Please refer to FIG. 17.

[0088] In some embodiments of the present application, the pressure measuring port 107 is in communication with the outside and the first lumen, at this time, the inner wall and the outer wall of the pressure measuring lumen both have openings with the openings of the inner wall and the openings of the outer wall radially corresponding, that is, the distal end of the pressure measuring lumen is not consistent with the distal end of the first lumen, and the pressure measuring port penetrates the outside and the first lumen. The dilator 60 forms a cavity inside, and the side wall of the cavity has a side hole 603 in communication with the distal pressure measuring port 107 of the pressure measuring lumen 105, and the foreign matter can enter the cavity from the side hole 603 of the dilator 60 and be discharged from the cavity.

[0089] The side hole 603 is not less than the diameter of the pressure measuring port 107. The diameter of the side hole 603 of the dilator 60 is not less than the diameter of the pressure measuring port 107, which ensures that the foreign matter can smoothly pass through the side hole 603 and be discharged from the cavity, prevents the pressure measuring lumen 105 from being blocked, and improves the safety and convenience of the surgical operation.

[0090] In other embodiments, please refer to FIG. 18, the dilator 60 is provided with a blocking part 60 to block the distal pressure measuring port 107 of the pressure measuring lumen 105 to limit the foreign matter from entering the pressure measuring lumen 105. In this way, when entering the cavity, the dilator 60 is pulled out of the sheath tube 102, avoiding the introduction of foreign matter into the pressure measuring lumen 105, ensuring the smoothness of the pressure measuring lumen 105 and the pressure measuring accuracy. For example, the blocking part 60 is made of flexible material to allow the dilator 60 to be pulled out of the sheath tube 102. The blocking part 60 is made of flexible material, allowing the dilator 60 to be smoothly pulled out of the sheath tube 102 during use, avoiding the inconvenience and potential damage caused by hard materials.

[0091] A gap is reserved between the blocking part 60 and the pressure measuring port 107. An appropriate gap is reserved between the blocking part 60 and the pressure measuring port 107 to ensure the blocking effect while avoiding the operation difficulty and pressure change of the pressure measuring lumen 105 caused by excessive sealing. The area of the outer wall of the dilator near the blocking part forms a groove 605 for the blocking part to retreat into the groove after exiting the pressure measuring port, so as to facilitate the smooth pulling out of the dilator from the sheath tube.

[0092] By setting the blocking part and the plugging part 60 on the dilator 60, the problem of blockage and pressure measurement accuracy reduction caused by foreign matter entering the pressure measuring lumen 105 during the process of entering the body cavity of the pressure measuring sheath 10 is solved.

[0093] In the present embodiment, referring to Fig. 20, the pressure measuring lumen 105 is provided with a pressure sensor 50 at the position close to the pressure measuring port, and a signal line 82 is arranged in the pressure measuring lumen to transmit the pressure signal. The pressure sensor 50 is a resistance bridge sensor 80, and the sensor is arranged at the distal end of the sheath. The temperature acts on the surface of the sensor, the resistance of the temperature measuring bridge arm changes, and a pressure difference is generated. At the same time, the gas and liquid pressure acts on the surface of the sensor, the sensor generates a micro-strain, the resistance of the pressure measuring bridge arm changes, and a pressure difference is generated. Then, the two groups of voltage signals are converted into digital signals by the internal collector, and finally the data is read out through the SPI interface. In this way, the resistance bridge sensor can measure both temperature and pressure, and through the principle of resistance change and pressure difference, accurate data collection and transmission are realized.

[0094] The distal cavity of the pressure measuring lumen 105 is provided with a protective sleeve, the resistance bridge sensor 80 is installed in the protective sleeve, and the sensing surface of the resistance bridge sensor 80 is in communication with the pressure measuring port 107 at the distal end of the pressure measuring lumen 105. Preferably, a stainless steel protective tube sleeve is used for protection, to avoid accidental extrusion or misfire of the sensor by laser energy devices.

[0095] The resistance sensor 80 transmits signals through the signal line 82 arranged in the pressure measuring lumen.

[0096] In the description of the present specification, the description of the terms "one embodiment", "some embodiments", "exemplary embodiment", "example", "specific example", or "some examples" means that the specific features, structures, materials or characteristics described in connection with the embodiment or example are included in at least one embodiment or example of the present application. In the present specification, the exemplary description of the above terms does not necessarily mean 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.

[0097] Although the embodiments of the present application have been shown and described, those skilled in the art can understand that various changes, modifications, replacements and variations can be made to the embodiments without departing from the principles and purposes of the present application, and the scope of the present application is defined by the claims and their equivalents.

[0098] Enter the free content description paragraph of the sequence listing here.

Claims

1. A guide sheath, comprising: The guide sheath comprises a sheath tube sized and shaped to access a target region in a body through a body lumen, and extending longitudinally from a proximal end to a distal end, the sheath tube defining at least a first lumen extending longitudinally from the proximal end to the distal end; a handle connected to the proximal end of the sheath tube so that the handle can be held outside the body, the handle comprising a handle body extending in a direction coinciding with the axis of the sheath tube for easy gripping by a user, and a first connector and a pressure regulator provided on the handle body, the handle body defining a port in communication with the first lumen for a medical instrument to access the first lumen, the first connector having a first passage in communication with the first lumen to constitute a drainage path, the first connector being adapted to be connected to a negative pressure device to drain liquid medium in the body outside the body through the drainage path, the pressure regulator being in communication with the first lumen and being disposed away from the drainage path so as not to contact the liquid when adjusting the pressure of the drainage path; a seal provided at the port, the seal comprising a passage therethrough for the medical instrument to pass through so as to form a sealed cavity between the first lumen and the body.

2. The introducer sheath of claim 1, wherein, The guide sheath further comprises a PCB board mounted in the handle body, the PCB board being provided with at least one data connector configured to be connected to an external perfusion and suction device to transmit signals; an operation button provided on the handle body and connected to the PCB board to control the operation state of the perfusion and suction.

3. The introducer sheath of claim 2, wherein, a pressure measuring lumen formed in the wall of the sheath tube and extending longitudinally from the proximal end towards the distal end, the pressure measuring lumen being provided with a pressure measuring port at the distal end for sensing the pressure of the liquid in the body, a pressure sensor being provided on the pressure measuring lumen or any path in communication therewith, the pressure sensor being connected to the PCB board; preferably, the handle comprises a second connector provided on the handle body, the second connector having a second passage in communication with the pressure measuring lumen, the pressure sensor being provided at the second passage to sense the pressure in the second passage; preferably, the sheath tube is sealingly connected to the handle body to form a calibration chamber in the handle body, the calibration chamber being in communication with the outside, the PCB board and the pressure sensor being arranged in the calibration chamber, the pressure sensor being a gauge pressure sensor, the second passage being provided with a pressure measuring hole in communication with the calibration chamber, the gauge pressure sensor being positioned in the chamber and at least its sensing diaphragm being arranged at the pressure measuring hole to collect the pressure in the pressure measuring lumen, and the second passage having an opening in communication with the outside, the opening being openable or closable by a sealing part, calibration of the pressure sensor being achieved by cooperation of the opening and the calibration chamber; preferably, the second connector is configured to be connected to an external air inlet device to eliminate the water meniscus tension of the pressure measuring lumen; optionally, the pressure measuring port is in communication with the outside and / or the first lumen; preferably, the distal end of the pressure measuring lumen is located proximally of the distal end of the first lumen, and the distal end of the pressure measuring lumen is provided with a pressure measuring port penetrating the outside and the first lumen; Optionally, the pressure measuring tube cavity is distally provided with a pressure sensor, and a signal line is arranged in the pressure measuring tube cavity to transmit the pressure signal collected by the pressure sensor to the PCB board. Optionally, at least the surface of the distal cavity of the pressure measuring tube cavity is coated with a hydrophilic or hydrophobic coating. Optionally, the second connecting member is provided with a one-way valve to allow gas to enter the pressure measuring tube cavity from the outside in one direction only.

4. The introducer sheath of claim 1, wherein, The bottom end of the first tube cavity is provided with a liquid outlet, the first connecting member is located below the handle body, and the axis of the first channel is perpendicular to the axis of the first tube cavity to form a straight liquid discharge path.

5. The introducer sheath of claim 1, wherein, The pressure regulating member includes a pressure regulating valve in communication with the first channel, and the first pressure regulating valve is arranged proximally of the first connecting member.

6. The introducer sheath of claim 3, wherein, The bottom of the handle body is provided with a hand holding positioning part, the first connecting member is arranged at the bottom of the handle body, the second connecting member is arranged at the side wall of the handle, and the pressure regulating member and the operation button are located at the upper part of the handle.

7. The introducer sheath of claim 1, wherein, The handle includes a third connecting member arranged on the handle body, the sheath defines an auxiliary tube cavity extending from the proximal end to the distal end, and the third connecting member is in communication with the auxiliary tube cavity to form a liquid supplementing channel.

8. The introducer sheath of claim 1, wherein, The pressure regulating member includes a pressure relief valve arranged on the handle body, the handle body is provided with a pressure relief cavity in communication with the first tube cavity, and the pressure relief valve seals or opens the pressure relief cavity; preferably, the pressure relief valve includes a pressing part connected with a pressure relief hose, and a valve is formed on the pressure relief hose to be opened and closed.

9. The introducer sheath of claim 1, wherein, The data connector is provided with an exhaust pipe in communication with the outside and the calibration chamber to maintain the pressure stability in the handle body; Optionally, the sealing member is connected to the proximal end of the sheath, the proximal end of the handle body is provided with a pressing member, the pressing member includes a pressing part pressing above the sealing member and a rotating part rotating with the handle body, the sealing member is provided with a lower pressure relief hole, the pressing part is provided with an upper pressure relief hole, and the lower pressure relief hole and the upper pressure relief hole are communicated by rotating the rotating part to rotate the pressing part to realize pressure stabilization.

10. A perfusion suction system, characterized in that The system comprises The guide sheath according to any one of claims 1-9, an endoscope sealingly passing through the port of the handle body into the first tube cavity, and a gap between the first tube cavity and the endoscope discharging the waste liquid in the body; a perfusion device connected with the endoscope to send the liquid medium into the body through the endoscope catheter; a suction device connected with the first connecting member to generate negative pressure in the liquid discharge path to suck the waste liquid containing the calculus out of the body; a main control machine connected with the perfusion device, the suction device and the PCB board to control the operation state of perfusion and suction. The system comprises The guide sheath according to any one of claims 1-9, an endoscope sealingly passing through the port of the handle body into the first tube cavity, and a gap between the first tube cavity and the endoscope discharging the waste liquid in the body; a perfusion device connected with the endoscope to send the liquid medium into the body through the endoscope catheter; a suction device connected with the first connecting member to generate negative pressure in the liquid discharge path to suck the waste liquid containing the calculus out of the body; a main control machine connected with the perfusion device, the suction device and the PCB board to control the operation state of perfusion and suction.

Citation Information

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