Improved pressure measuring sheath

Abstract

The utility model provides an improved pressure measuring sheath which comprises a sheath tube and a handle, the handle comprises a handle body, a first connecting piece and a second connecting piece, the first connecting piece and the second connecting piece are arranged on the handle body, and the handle body extends in the direction consistent with the axis of the sheath tube so that a user can hold the handle body conveniently. The pressure sensor is positioned in the handle main body, and at least a sensing film of the pressure sensor is arranged at the pressure measuring hole to collect pressure in the pressure measuring pipe cavity; the sealing element is arranged at the port and comprises a passage penetrating through the sealing element, so that a sealing cavity is formed between the first pipe cavity and the body after the medical instrument penetrates through the passage; the PCB is installed in the handle main body, the PCB is provided with at least one data connector, the data connector extends out of the handle main body, and the data connector is configured to be suitable for being connected with suction equipment for transmitting signals through external perfusion; and the operation key is arranged on the handle main body and is connected with the PCB so as to control the operation states of filling and suction.

Description

TECHNICAL FIELD

[0001] The utility model belongs to the field of medical devices, more particularly to an improved pressure measuring sheath. BACKGROUND

[0002] In a conventional ureteroscopy lithotripsy surgery, the powder of the calculus and the hematuria in the renal pelvis can cause blurred vision, and it is necessary to perfuse the flushing liquid to keep the vision clear, but at the same time, the pressure in the renal pelvis can be obviously increased due to too fast perfusion and poor backflow, causing the infection urine, bacteria and endotoxin to enter the blood and lymph circulation, resulting in fever and systemic inflammatory response syndrome of the patient after the surgery, and even causing fatal urosepticemia. In order to prevent serious infection caused by high pressure in the renal pelvis during the soft lens surgery, it is necessary to control the pressure in the renal pelvis within a safe range during the surgery, and it is further necessary to adjust the perfusion speed and / or the level of negative pressure suction according to the feedback of the pressure in the renal pelvis during the surgery. Whether the pressure measuring method can measure the pressure in the renal pelvis in real time and accurately is the cornerstone to ensure that the pressure measuring and controlling system has good performance and the operation is safe.

[0003] The ureter pressure measuring sheath 10 is mainly used for establishing an operation channel for treatment in the clinical treatment of ureteral stenosis, adhesion, obstruction, blockage and calculus, and introducing an endoscope 20, a laser fiber, a stone removal instrument or an operation cable through the channel. At the same time, in order to keep the vision clear in the existing urological surgery, it is necessary to perfuse the flushing liquid, but the pressure in the renal pelvis can be obviously 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 the change of the pressure in the renal pelvis, it is necessary to control the pressure in the renal pelvis within a safe range during the surgery.

[0004] The existing flexible pressure measuring sheath retains a pressure measuring lumen, a sensor and a pressure measuring control module are placed on a main control machine or a main control machine pipeline, then connected through a 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 precision of the structure is greatly affected by the pipeline, the pressure measuring precision 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 a pressure measuring control module on the main machine or the main machine pipeline, and the sensor and the pressure measuring control module are connected through a cable. The structure has poor controllability, and the pressure measuring precision cannot be completely guaranteed. UTILITY MODEL CONTENTS

[0005] The utility model provides an improved pressure measuring sheath, the pressure measuring sheath includes:

[0006] 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 and a manometer lumen spaced apart from the first lumen;

[0007] a handle connected to the proximal end of the sheath tube so as to 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, and a first connector and a second connector 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 the liquid medium in the body outside through the drainage path;

[0008] a pressure regulator in communication with the first lumen and disposed away from the drainage path so as not to contact the liquid when regulating the pressure of the drainage path, the second connector having a second passage in communication with the manometer lumen, the second passage having a pressure measuring hole in communication with the calibration chamber on its outer wall;

[0009] a pressure sensor positioned in the handle body with at least its sensing diaphragm disposed at the pressure measuring hole to collect the pressure in the manometer lumen;

[0010] a sealing member disposed at the port, the sealing member including a passage therethrough for the medical instrument to pass through to form a sealed cavity between the first lumen and the body;

[0011] a PCB board mounted in the handle body, the PCB board being provided with at least one data connector extending out of the handle body, the data connector being 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, the sealing member is provided with an upper pressure relief hole, and the handle housing is provided with a switch to open or close the upper pressure relief hole.

[0014] In some embodiments, the first lumen is provided with a liquid outlet at its bottom end, the first connector is located 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 data connector has an exhaust pipe in communication with the outside and the handle housing to maintain the pressure stability in the cavity of the handle housing.

[0016] In some embodiments, the first connecting member is arranged at the bottom of the handle body, the second connecting member is arranged at the sidewall of the handle, and the operation button is located at the upper part of the handle.

[0017] 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 cavity in communication with the first lumen, and the pressure relief valve seals or opens the pressure relief cavity; preferably, the pressure relief valve comprises a pressing portion connected with a pressure relief hose, and a valve is formed on the pressure relief hose.

[0018] In some embodiments, the sheath comprises an elongated sheath, a sealing member is connected to the proximal end of the sheath, the proximal end of the handle shell is provided with a pressing member, the pressing member comprises a pressing portion pressing above the sealing member and a rotating portion rotating with the handle shell, the sealing member is provided with a lower pressure relief hole, the pressing portion 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 ring to rotate the pressing portion to realize pressure stabilization.

[0019] In some embodiments, a first connecting portion adapted to detachably connect with the dilator is arranged at the port of the handle shell.

[0020] In some embodiments, the detachable connection is a snap connection.

[0021] In some embodiments, the proximal end of the handle shell is further provided with a limiting portion preventing the dilator from being pulled out.

[0022] In some embodiments, the distal end of the sheath is a flexible section.

[0023] The 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 through the practice of the present application. BRIEF DESCRIPTION OF DRAWINGS

[0024] 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:

[0025] Figure 1 The structure schematic diagram of the perfusion system related to the pressure measuring sheath provided by the present application;

[0026] Figure 2 The principle schematic diagram of the pressure measuring sheath provided by the embodiment of the present application;

[0027] Figure 3 The structure schematic diagram of the pressure measuring sheath (cooperating with the dilator) provided by the present application;

[0028] Figure 4Part structure diagram of the pressure measuring sheath (with dilator) of the present application;

[0029] Figure 5 Part structure diagram of the pressure measuring sheath (with dilator) of the present application;

[0030] Figure 6 Part structure diagram of the pressure measuring sheath (with dilator) of the present application;

[0031] Figure 7 Part structure diagram of the pressure measuring sheath (with dilator) of the present application;

[0032] Figure 8 Part structure diagram of the pressure measuring sheath (with dilator) of the present application;

[0033] Figure 9 Part structure diagram of the pressure measuring sheath (with dilator) of the present application;

[0034] Figures 10-13 Part structure diagram of the pressure measuring sheath (with dilator) of the present application;

[0035] Figure 14 Part structure diagram of the pressure measuring sheath (with dilator) of the present application;

[0036] Figures 15-16 Part structure diagram of the pressure measuring sheath (with dilator) of the present application;

[0037] Figures 17-18 Part structure diagram of the pressure measuring sheath (with dilator) of the present application;

[0038] Figure 19 Part structure diagram of the pressure measuring sheath (with dilator) of the present application;

[0039] Figure 20 Part structure diagram of the pressure measuring sheath (with dilator) of the present application;

[0040] Wherein,

[0041] 10-pressure measuring sheath, 11-data joint, 20-endoscope, 200-endoscope catheter

[0042] 101-handle body, 102-sheath, 103-calibration chamber, 104-first lumen, 105-pressure measuring lumen, 106-seal, 107-pressure measuring port, 108-port, 109-ring, 120-first connecting piece, 121-third connecting piece, 122-first sealing cap, 123-accessory lumen, 124-second connecting piece, 125-second sealing cap, 126-pressure measuring hole, 127-pressure relief chamber, 18-pressure regulating piece, 128-pressing part, 130-pressure relief hole, 131-switch, 132-first connecting part, 133-pressing part, 134-rotating part, 135-limiting part, 136-flexible section, 138-valve;

[0043] 50-pressure sensor, 51-PCB board, 52-data connector, 521-wire core, 522-insulating outer covering, 53-connector, 54-operation button, 55-exhaust pipe;

[0044] 60-dilator, 601-second connecting part, 602-dilator lumen, 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;

[0045] 80-resistance bridge sensor, 81-stainless steel sleeve, 82-signal line;

[0046] 90-first negative pressure suction tube, 91-suction container, 92-second negative pressure suction tube, 93-liquid storage container, 94-liquid inlet tube, 95-liquid outlet tube, 100-machine box, 201-endoscope cable, 202-image processor. DETAILED DESCRIPTION

[0047] In the description of the present application, it should be understood that the terms "front", "back", "head", "tail", "distal", "proximal", "axial" and "radial" indicate the orientation or positional relationship shown in the drawings, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element 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.

[0048] 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 the specific meaning of the above terms can be understood by those skilled in the art according to the specific circumstances.

[0049] Please refer to Figure 1The 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 detection component and a main control machine, the endoscope 20 is inserted into the pressure measuring sheath 10 to observe the inside of 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 detection component comprises a pressure sensor 50, which is used to detect the intracavity pressure in the renal pelvis, and the pressure detection 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 channel of the pressure measuring sheath 10 under negative pressure, the waste liquid and stones are collected into the suction container 91 through the negative pressure suction pipe, and 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 pipe 90, a suction container 91 and a second negative pressure suction pipe 92, the first negative pressure suction pipe 90 connects the diaphragm pump and the suction container 91, and the second negative pressure suction pipe 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 case 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.

[0050] 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.

[0051] Embodiment 1

[0052] Please refer to Figures 2-13 The pressure measuring sheath 10 provided by 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.

[0053] 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.

[0054] 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 when a medical instrument is passed through the passageway.

[0055] 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.

[0056] Please refer to Figure 8 The handle body 101 is further provided with a pressure regulating member 18 for regulating the pressure of the first lumen, so that 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, 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 disposed on the handle body 101 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 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 channel. By controlling the pressure fluctuation, stronger suction force can be provided when needed, improving the efficiency and success rate of the operation.

[0057] 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.

[0058] 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. In this way, 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, which greatly simplifies 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.

[0059] 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 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.

[0060] 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 waste liquid through an inclined side arm extending from the sheath tube 102, the present application forms a straight discharge path for discharging 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 to the liquid outlet without a bent pipe, the waste liquid and stones do not need to change the flow direction when being discharged. This design significantly reduces the probability of stones being trapped and stuck in the pipe. 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.

[0061] 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 catheter. 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 to the proximal end of the sheath tube, and is used for sealing penetration of the elongated dilator 60 or the catheter 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.

[0062] 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 prevent the dilator 60 from being rotated and pulled out during use of the dilator 60 matched with the sheath, thereby facilitating operation and improving efficiency.

[0063] 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 operating part and a bending part, and the operating 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.

[0064] Embodiment 2

[0065] On the basis of 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 extending longitudinally from the proximal end to the distal end is formed in the tube wall of the sheath tube, wherein the pressure measuring lumen 105 is arranged side by side with the first lumen 104, and a pressure measuring port for sensing the pressure of the liquid in the body is arranged at the distal end of the pressure measuring lumen 105, and the handle comprises a second connecting member 124 arranged on the handle body, the second connecting member 124 has a second channel communicating with the pressure measuring lumen 105, and a pressure sensor is arranged on the pressure measuring lumen 105, the second channel or any path communicating therewith, which can all collect the pressure data of the pressure measuring lumen. Exemplarily, the pressure sensor 50 can be arranged at the distal end of the endoscope 20, at the distal end of the pressure measuring sheath 10, in the pressure measuring lumen 105 in the pressure measuring sheath 10, or at any position on the pressure measuring path communicating with the pressure measuring lumen 105, such as on an external device, and the positions herein include but are not limited to the second connecting member 124 communicating with the pressure measuring lumen 105.

[0066] Further, in the present embodiment, the pressure sensor 50 is mounted on the inner side or the outer side of 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 on the inner side of 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 other auxiliary lumens, avoiding resource occupation by other instruments. It can be understood that the detection signal of the pressure sensor 50 can be connected with external devices through a connecting line for signal transmission and processing, etc.

[0067] 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 build 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 positioned 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 to the outside, and the opening can be opened 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.

[0068] 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. When the pressure sensing sheath is not inserted into 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 is inserted into the body, the second sealing cap 125 is opened, the second channel is open and in communication with the outside, at this time, the calibration of the gauge pressure sensor is realized in cooperation with the calibration chamber 103. 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, which reduces the volume of the pressure sensing cavity, quickly and accurately responds to pressure changes, avoids the attenuation and lag of the signal in a large space, and has higher precision.

[0069] 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.

[0070] Please refer to Figure 19 , the data connector 52 (including the wire core 521 and the insulating outer covering 522) has an exhaust pipe 55 in communication with the outside and the handle main body 101 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 operations 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 the operation simplicity are ensured.

[0071] As mentioned before, the distal end of the pressure sensing cavity 105 has a pressure sensing port 107, which is suitable for sensing the pressure in the human body cavity and transmitting it to the pressure sensing cavity. The pressure sensing port can be arranged in various ways: for example, please refer to Figure 10 , the pressure sensing port 107 is in communication with the outside, but not in communication with the first cavity 104, i.e. the outer wall of the pressure sensing cavity 105 is opened to form the pressure sensing port. The outer communication type pressure sensing port is in communication with the high pressure area in the cavity, has higher measurement accuracy, and can truly feedback the pressure in the cavity, but foreign matters are easy to enter the pressure sensing cavity through the outer pressure sensing port, and the pressure sensing accuracy will decrease after the pressure sensing cavity is blocked; another embodiment is shown in Figure 11, the pressure measuring port 107 is in communication with the first lumen 104 and not with the outside, that is, the inner wall of the pressure measuring lumen 105 has an opening to form a pressure measuring port, which is in communication with the low pressure area in the cavity, the measured value is relatively lower than the overall pressure in the cavity, but the risk of foreign matter blocking the pressure measuring lumen is excluded; in another embodiment, please refer to Figure 12 and Figure 13 , the pressure measuring port 107 is in communication with the outside and the first lumen 104, at this time, the inner wall and the outer wall of the pressure measuring lumen 105 have openings, and in this embodiment, the openings of the inner wall and the openings of the outer wall correspond radially, the full-through type pressure measuring channel port is in communication with the high pressure area and the low pressure area in the cavity at the same time, the measurement accuracy is higher, and the cavity pressure can be truly fed back, but there is also the risk of pipe blocking. Or the openings of the inner wall and the openings of the outer wall are staggered, for example, in the form of Z, 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, the measurement accuracy is higher, and the cavity pressure can be truly fed back, and there is no risk of pipe blocking. More preferably, the distal end of the pressure measuring lumen 105 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 port penetrating the outside and the first lumen, 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.

[0072] In some embodiments of the present application, the proximal end of the sheath 102 is provided with a pressure relief hole 130, which is adapted to communicate with the outside to facilitate the entry of air. When the sheath 102 is placed into operation through an instrument or the like, it will cause pressure fluctuation, and by opening the pressure relief hole 130 to introduce an appropriate amount of air, the stability of the cavity pressure can be ensured. In this way, the pressure fluctuation caused by external operation is avoided, and the pressure measurement accuracy is improved. 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 the embodiments of the present application, the proximal end of the sheath 102 is provided with a sealing member 106, and the endoscope 20 or the dilator 60 is sealingly inserted into the sheath 102. The sealing member 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, so as to solve the influence of pressure fluctuation caused by the entry of an instrument or the like on pressure detection, and to achieve small-scale pressure relief. Alternatively, the sheath 102 comprises a sealing member 106 and an elongated sheath, the sealing member 106 has a valve port, the sealing member 106 is connected to the proximal end of the sheath, and the valve port is for the sealing penetration of the elongated dilator 60 or endoscope 20, the proximal end of the handle body 101 is provided with a pressing member, the pressing member comprises a pressing part 133 which is pressed above the sealing member 106 and a rotating part 134 which is rotationally connected with the handle body 101, the sealing member 106 is provided with a lower pressure relief hole 130, and the pressing part 133 is provided with an upper pressure relief hole 130, the rotating ring is rotated to drive the pressing part 133 to rotate, so that the lower pressure relief hole 130 communicates with the upper pressure relief hole 130 to achieve pressure stabilization.

[0073] Embodiment 3

[0074] In some embodiments of the present application, the present application utilizes dual channel perfusion, the flow of fluid between different channels is affected by the pressure difference. The liquid in the high pressure area will flow to the low pressure area, while the low pressure area will attract more fluid. The endoscope 20 enters the sheath tube 102, the waste liquid is sucked out of the body through the first lumen 104 of the sheath tube 102, the liquid enters the body through the endoscope 20 conduit, one suction and one injection, when the negative pressure suction pressure in the sheath tube 102 is very large, the pressure inside the sheath tube 102 is much lower than the pressure in the endoscope 20, such a large pressure difference will cause more liquid to enter the body, at this time it will cause the perfusion of the liquid to be too large, and form a too high perfusion pressure in the local area, causing the waste liquid such as stones to be difficult to suck.

[0075] Based on this, the handle body 101 of the present embodiment is provided with a third connecting piece 121, which can be blocked by a first sealing cap 122. When liquid needs to be sent, the first sealing cap 122 is opened, and when it is not needed, the first sealing cap 122 is closed, so as to avoid the influence on the negative pressure. The sheath tube 102 has an auxiliary lumen 123 which is 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, so that 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 stones, promoting the loosening and movement of the stones. The pressure fluctuation will periodically change the flow rate and direction of the liquid, thereby generating an impact force on the stones, gradually reducing the adhesion and static friction between the stones and the surrounding tissue. In addition, the introduction of the auxiliary lumen 123 provides more liquid inlet paths, ensuring the stable supply of liquid medium, avoiding the pressure instability caused by uneven liquid supply in a single channel, and solving the technical problem that the stones are difficult to be effectively sucked due to excessive perfusion pressure.

[0076] 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.

[0077] Embodiment 4

[0078] A 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 for the pressure signal to be transmitted to the pressure sensor 50 in a timely and accurate manner, 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.

[0079] Based on this, in some embodiments of the present application, the pressure measuring sheath 10 further comprises a tension eliminating mechanism to eliminate the influence of water film on intracavity pressure detection

[0080] As mentioned before, please refer to Figure 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 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 Figure 15 , open the second sealing cap 125 of the second channel 124, and send 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 of the pressure measuring module P=P3+P4=P1+P2 (when the water film tension balance is broken P4=P2, P=P3=P1), wherein P1 is the intracavity 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 tube 70.

[0081] In addition, a one-way valve 74 is provided 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 water film tension. If the one-way valve 74 is not provided, 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 a pressure difference in the pressure measuring tube cavity 105, combined with the influence of water film, causing the pressure measuring accuracy to decline. 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.

[0082] In other embodiments, please refer to Figure 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 P=P3=P1. Reducing the retention of water film, improving the self-cleaning ability and measurement accuracy of the pressure measuring tube cavity 105.

[0083] This embodiment effectively eliminates the influence of 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,

[0084] Example 5

[0085] When the pressure sensing sheath 10 (usually used in catheterization and other surgical procedures) enters the body cavity, the negative pressure suction and perfusion have not yet begun. At this time, the dilator 60 has been inserted into the pressure sensing sheath 10 to ensure that the pressure sensing 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 sensing lumen 105, causing the pressure sensing lumen 105 to be blocked, and the pressure sensing accuracy to drop sharply.

[0086] The dilator 60 is provided with a blocking part to limit the entry of foreign matter into the pressure sensing lumen 105 through the pressure sensing port 107. Please refer to Figure 17 .

[0087] In some embodiments of the present application, the pressure sensing 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 sensing lumen have openings in the inner wall and the outer wall of the opening corresponding to the radial direction, that is, the distal end of the pressure sensing lumen is not consistent with the distal end of the first lumen, and the pressure sensing 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 end of the pressure sensing lumen 105 and the pressure sensing port 107, and the foreign matter can enter the cavity from the side hole 603 of the dilator 60 and be discharged from the cavity.

[0088] The side hole 603 is not less than the diameter of the pressure sensing port 107. The diameter of the side hole 603 of the dilator 60 is not less than the diameter of the pressure sensing 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 sensing lumen 105 from being blocked, and improves the safety and convenience of the surgical operation.

[0089] In other embodiments, please refer to Figure 18 , the dilator 60 is provided with a blocking part 60 that can block the pressure sensing port 107 at the distal end of the pressure sensing lumen 105 to limit the entry of foreign matter into the pressure sensing 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 sensing lumen 105, ensuring the smoothness of the pressure sensing lumen 105 and the pressure sensing 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.

[0090] A gap is reserved between the blocking part 60 and the pressure sensing port 107. A suitable gap is reserved between the blocking part 60 and the pressure sensing port 107 to ensure the blocking effect while avoiding the difficulty of operation and the pressure change of the pressure sensing lumen 105 caused by excessive sealing. The area of the dilator outer wall near the blocking part forms a groove 605 for the blocking part to retract into the groove after exiting the pressure sensing port, so as to facilitate the smooth extraction of the dilator from the sheath tube.

[0091] 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.

[0092] In the present embodiment, referring to Figure 20 , the pressure measuring lumen 105 is provided with a pressure sensor 50 at a 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.

[0093] The distal cavity of the pressure measuring lumen 105 is provided with a protective sleeve, and the resistance bridge sensor 80 is installed in the protective sleeve. 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, and a stainless steel protective tube sleeve is preferably used for protection, so as to avoid accidental extrusion of the sensor or accidental impact of laser energy devices.

[0094] The resistance sensor 80 transmits signals through the signal line 82 arranged in the pressure measuring lumen.

[0095] 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 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.

[0096] 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.

Claims

1. An improved pressure-sensing sheath, characterized in that, The pressure-measuring sheath includes: A sheath, sized and shaped to enter a target area within the body through a body lumen, and extending longitudinally from the proximal end to the distal end, the sheath defining at least a first lumen extending longitudinally from the proximal side to the distal side and a pressure measuring lumen, the pressure measuring lumen being spaced apart from the first lumen and arranged side by side; A handle is attached to the proximal side of the sheath to allow it to be held outside the body. The handle includes a handle body and a first connector and a second connector disposed on the handle body. The handle body extends in a direction consistent with the axis of the sheath for easy gripping by the user. The handle body defines a port communicating with a first lumen to allow a medical device to enter the first lumen through the port. The first connector has a first channel communicating with the first lumen to form a drainage path. The first connector is adapted to be connected to a negative pressure device to allow liquid media in the body to be discharged from the body through the drainage path. The pressure regulating component is connected to the first cavity and is positioned to avoid the drain path so as not to come into contact with the liquid when adjusting the pressure of the drain path; the second connecting component has a second channel connected to the pressure measuring cavity, and the outer wall of the second channel is provided with a pressure measuring hole connected to the calibration chamber. A pressure sensor is positioned within the handle body and at least its sensing diaphragm is disposed at the pressure measuring port to collect the pressure within the pressure measuring chamber; A seal is disposed at the port, the seal including a passage therethrough such that a medical device forms a sealed cavity between a first lumen and the body after passing through the passage; A PCB board is installed inside the handle body. The PCB board has at least one data connector that extends from the handle body and is configured to be connected to an external infusion and suction device to transmit signals. The operation buttons are located on the handle body and connected to the PCB board to control the infusion and aspiration operation.

2. The pressure-measuring sheath according to claim 1, characterized in that, The sealing element is provided with an upper pressure relief hole, and the handle housing is provided with a switch that can open or close the upper pressure relief hole.

3. The pressure-measuring sheath according to claim 1, characterized in that, The bottom end of the first tube is provided with a liquid outlet, the first connector is located below the handle body, and the axis of the first channel is perpendicular to the axis of the first tube to form a straight drainage path.

4. The pressure-measuring sheath according to claim 1, characterized in that, The data connector has an exhaust pipe that connects to the outside and the handle housing to maintain pressure stability within the handle housing cavity.

5. The pressure-measuring sheath according to claim 1, characterized in that, The first connector is located at the bottom of the handle body, the second connector is located on the side wall of the handle, and the operation button is located at the top of the handle.

6. The pressure-measuring sheath according to claim 1, characterized in that, The pressure regulating component includes a pressure relief valve disposed on the handle body, and the handle body is provided with a pressure relief chamber communicating with the first pipe cavity. The pressure relief valve seals or opens the pressure relief chamber. Preferably, the pressure relief valve includes a pressing part, the pressing part is connected to a pressure relief hose, and an openable and closable valve is formed on the pressure relief hose.

7. The pressure-measuring sheath according to claim 3, characterized in that, The sheath includes a slender sheath, and a seal is connected to the proximal end of the sheath. The proximal end of the handle housing is provided with a pressing member, which includes a pressing part pressing on the seal and a rotating part rotating with the handle housing. The seal is provided with a lower pressure relief hole, and the pressing part is provided with an upper pressure relief hole. The pressing part is rotated by rotating the rotating ring so that the lower pressure relief hole and the upper pressure relief hole communicate to achieve pressure stabilization.

8. The pressure-measuring sheath according to claim 1, characterized in that, The handle housing has a first connecting part at its port that is suitable for detachable connection with the expander.

9. The pressure-measuring sheath according to claim 8, characterized in that, The detachable connection is a snap-fit ​​connection.

10. The pressure-measuring sheath according to claim 6, characterized in that, The handle housing also has a limiting part near the end to prevent the expander from coming out.

11. The pressure-measuring sheath according to claim 1, characterized in that, The distal end of the sheath is a flexible segment.

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