Guiding device for improving pressure measurement precision and dilator

By incorporating a guiding device with a pressure measuring lumen and pressure sensor within the pressure measuring sheath, combined with a dilator and integrated operation buttons, the problems of pressure measuring accuracy and ease of operation of existing ureteral pressure measuring sheaths are solved, achieving more efficient and safer intrarenal pelvic pressure control.

CN223667925UActive Publication Date: 2025-12-16ZHEJIANG YIGAO MEDICAL TECH CO LTD
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Patent Information

Application Number
CN202421512994.0
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2024-06-28
Publication Date
2025-12-16
Estimated Expiration
2034-06-28

AI Technical Summary

Technical Problem

Existing ureteral manometry sheaths are insufficient in terms of pressure measurement accuracy and ease of operation, making it difficult to control intrarenal pelvic pressure in real time and accurately, which increases the risk of infection during surgery and increases the complexity of the operation.

Method used

A guiding device was designed, including a pressure measuring sheath and an expander. The pressure measuring sheath contains a pressure measuring cavity and a pressure sensor. The expander is used to prevent foreign objects from entering the pressure measuring cavity. The handle integrates operation buttons and a PCB board, enabling convenient control of infusion and suction, and improving pressure measurement accuracy and operation efficiency.

Benefits of technology

This improved the pressure measurement accuracy of the pressure measuring sheath, simplified the operation process, reduced the risk of infection, and improved the safety and efficiency of the surgery.

✦ Generated by Eureka AI based on patent content.

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Abstract

The utility model provides a guiding device and dilator for improving pressure measurement accuracy, the guiding device comprises a pressure measurement sheath, the pressure measurement sheath comprises a handle and a sheath tube, the size and shape of the sheath tube are suitable for entering a target area in a body through a body lumen, the sheath tube longitudinally extends from a near end to a far end, the sheath tube defines a first lumen suitable for entering of an external instrument, and the first lumen is communicated with the handle. A pressure measuring tube cavity longitudinally extending from the near end to the far end is formed in the tube wall of the sheath tube, a pressure measuring opening used for sensing the pressure of liquid in the body is formed in the far side of the pressure measuring tube cavity, and the dilator is arranged in the first tube cavity in a supporting and penetrating mode so that the pressure measuring sheath can enter the body conveniently. And the dilator is provided with a blocking part for limiting foreign matters from entering the pressure measuring tube cavity through the pressure measuring port.
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Description

TECHNICAL FIELD

[0001] The utility model belongs to the field of medical apparatus and instruments, and particularly relates to a guide device for ureter flexible mirror lithotripsy surgery and a dilator. BACKGROUND

[0002] In conventional ureter flexible mirror lithotripsy surgery, the powder of the calculus and the hematuria in the renal pelvis can cause blurred vision, and perfusion of the flushing liquid is needed 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 urine, bacteria and endotoxin of the infection 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 too high pressure in the renal pelvis during the flexible mirror surgery, it is needed to control the pressure in the renal pelvis in a safe range during the surgery, and it is further needed to adjust the perfusion speed and / or the high and low values of the negative pressure suction according to the feedback of the pressure in the renal pelvis during the surgery, and whether the pressure measurement method can measure the pressure in the renal pelvis in real time and accurately is the cornerstone to ensure that the pressure measurement and control system has good performance and the operation is safe.

[0003] The ureter pressure measurement sheath 10 is mainly used for establishing an operation channel for treatment when ureter stenosis, adhesion, obstruction, blockage and calculus occur, and endoscopes 20, laser fibers, stone removal instruments or operation cables are introduced through the channel. At the same time, in order to keep the vision clear during the existing urological surgery, the flushing liquid needs to be perfused, but the pressure in the renal pelvis can be obviously increased due to too fast perfusion and poor backflow, and 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, the pressure in the renal pelvis needs to be controlled in a safe range during the surgery.

[0004] The existing bendable pressure measurement sheath retains the pressure measurement lumen, the sensor and the pressure measurement control module are placed on the main control machine or the main control machine pipeline, then the pressure is transmitted to the sensor through the connection of the pipeline and the pressure measurement lumen of the pressure measurement sheath, however, the pressure measurement accuracy of the structure is greatly affected by the pipeline, the pressure measurement 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 removal. In addition, some schemes also install the pressure sensor on the pressure measurement sheath or the endoscope, and the pressure measurement control module is on the main machine or the main machine pipeline, and the sensor and the pressure measurement control module are connected through a cable, the operability of the structure is poor, and the pressure measurement accuracy cannot be completely guaranteed. UTILITY MODEL CONTENTS

[0005] The utility model provides a guide device, the guide device includes

[0006] A pressure measuring sheath comprising a handle and 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 a first lumen adapted for passage of an external instrument, and a pressure measuring lumen formed within the sheath tube wall extending longitudinally from the proximal end toward the distal end, the pressure measuring lumen having a pressure measuring port at the distal end adapted for sensing pressure of a fluid within the body, the pressure measuring port in communication with the outside and the first lumen, and a pressure sensor at any location along the pressure measuring lumen or a path in communication therewith;

[0007] The handle comprises a handle body defining a port in communication with the first lumen, the port having a seal member with a passage therethrough to form a sealed cavity between the first lumen and the body after a medical instrument passes through the passage, and a first connector on the handle body, the first connector having a first channel in communication with the first lumen to form a drainage path, the first connector adapted to be connected to a negative pressure device to drain the fluid medium within the body through the drainage path.

[0008] A dilator supported within the first lumen to facilitate passage of the pressure measuring sheath into the body, the dilator having a blocking portion to limit passage of foreign matter into the pressure measuring lumen through the pressure measuring port.

[0009] In some embodiments, the dilator has a cavity formed inside, the cavity having a side hole in the side wall in communication with the pressure measuring port, and foreign matter can pass into the cavity from the side hole.

[0010] In some embodiments, the dilator has a blocking portion to block the pressure measuring port at the distal end of the pressure measuring lumen to limit passage of foreign matter into the pressure measuring lumen.

[0011] In some embodiments, the blocking portion is made of a flexible material to allow the dilator to be withdrawn from the sheath tube.

[0012] In some embodiments, the side hole is not smaller than the diameter of the pressure measuring port.

[0013] In some embodiments, a gap is provided between the blocking portion and the pressure measuring port.

[0014] In some embodiments, a groove is formed on the outer wall of the dilator adjacent to the blocking portion to allow the blocking portion to be retracted into the groove after being withdrawn from the pressure measuring port.

[0015] In some embodiments, a pressure sensor is provided at a location of the pressure measuring lumen adjacent to the pressure measuring port, and a signal line is provided within the pressure measuring lumen to transmit a pressure signal.

[0016] In some embodiments, a protective sleeve is arranged in the pressure measuring tube cavity, the pressure sensor is arranged in the protective sleeve, and the sensing part of the pressure sensor is in communication with the pressure measuring port; preferably, the pressure sensor is a resistance bridge type sensor, and the protective sleeve is a stainless steel protective sleeve.

[0017] In some embodiments, the pressure measuring sheath further comprises:

[0018] A PCB is arranged in the handle body, and at least one data connector is arranged on the PCB, the data connector being configured to be connected to an external perfusion and suction device, and the pressure sensor is connected to the PCB through a signal line;

[0019] An operation button is arranged on the handle body, and the PCB is connected to control the running state of perfusion and suction.

[0020] The dilator is also provided in the utility model.

[0021] The dilator provided in the utility model solves the problem of blockage and pressure measuring precision reduction caused by foreign matter entering the pressure measuring tube cavity during the process of the pressure measuring sheath entering the body cavity, and improves the pressure measuring precision of the pressure measuring sheath.

[0022] Additional aspects and advantages of the utility model 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 utility model. BRIEF DESCRIPTION OF DRAWINGS

[0023] The above and / or additional aspects and advantages of the utility model will become apparent and more readily appreciated from the following description of the embodiments, with reference to the following drawings, in which:

[0024] Figure 1 The structure schematic view of the perfusion system related to the pressure measuring sheath provided in the utility model is shown in the figure;

[0025] Figure 2 The principle schematic view of the pressure measuring sheath provided in the utility model is shown in the figure;

[0026] Figure 3 The structure schematic view of the pressure measuring sheath (cooperating with the dilator) provided in the utility model is shown in the figure;

[0027] Figure 4 The partial structure schematic view of the pressure measuring sheath (cooperating with the dilator) provided in the utility model is shown in the figure;

[0028] Figure 5 The structure split schematic view of the pressure measuring sheath (cooperating with the dilator) provided in the utility model is shown in the figure;

[0029] Figure 6 The structure sectional view of the pressure measuring sheath provided in the utility model is shown in the figure;

[0030] Figure 7 The utility model provides a structure side view of pressure measuring sheath provided by the utility model,

[0031] Figure 8 The utility model provides a structure section view of pressure measuring sheath provided by the utility model,

[0032] Figure 9 The utility model provides a far -end schematic view of pressure measuring sheath ( cooperate dilator),

[0033] Figures 10-13 The utility model provides a structure schematic view of pressure measuring mouth provided by the utility model,

[0034] Figure 14 The utility model provides a schematic view of pressure measuring sheath pump in carbon dioxide provided by the utility model,

[0035] Figures 15-16 The utility model provides a pressure measuring sheath pressure detection principle schematic view provided by the utility model,

[0036] Figures 17-18 The utility model provides a structure section view of pressure measuring sheath far -end provided by the utility model,

[0037] Figure 19 The utility model provides a structure section view of cable provided by the utility model,

[0038] Figure 20 The utility model provides a structure schematic view of sheath tube ( far -end configuration sensor) provided by the utility model.

[0039] Among them,

[0040] 10-pressure measuring sheath, 11-data joint, 20-endoscope, 200-endoscope catheter

[0041] 101-handle main body, 102-sheath tube, 103-calibration chamber, 104-first lumen, 105-pressure measuring lumen, 106-sealing element, 107-pressure measuring mouth, 108-port, 109-ring, 120-first connecting piece, 121-third connecting piece, 122-first sealing cap, 123-assistant 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;

[0042] 50-pressure sensor, 51-PCB board, 52-data joint, 521-wire core, 522-insulating outer covering, 53-joint, 54-operation button, 55-exhaust pipe;

[0043] 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;

[0044] 80-resistance bridge sensor, 81-stainless steel sleeve, 82-signal line;

[0045] 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 wire harness, 202-image processor. DETAILED DESCRIPTION

[0046] In the description of the utility model, it is understood that the terms "front", "back", "head", "tail", "far", "near", "axial" and "radial" and the like indicate the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the utility model and simplifying the description, and do not indicate or imply that the device or element must have a particular orientation, be constructed and operated in a particular orientation, therefore, it cannot be understood as a limitation of the utility model.

[0047] In the description of the utility model, it should be pointed out that, unless otherwise specified and limited, the terms "installation", "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 directly connected, or indirectly connected through intermediate medium, for those skilled in the art, the specific meaning of the above terms can be understood according to the specific circumstances.

[0048] Please refer to Figure 1The utility model discloses a perfusion suction system, the system includes pressure measuring sheath 10, endoscope 20, perfusion device, suction device, pressure detection component and host computer, endoscope 20 is inserted in pressure measuring sheath 10 to observe in renal pelvis, perfusion device utilizes liquid medium to carry out pressure expansion to patient's inner cavity to form visible interval, and can clean the impurity in the cavity, and the doctor observes and surgical field clear through endoscope 20, suction device is used to suck the waste liquid in patient's inner cavity and export the body, and pressure detection component includes pressure sensor 50, and the pressure sensor 50 is used to detect the cavity pressure in renal pelvis, and the pressure detection component, perfusion device, suction device are connected with host computer, that is, host computer controls the flow and pressure of perfusion device and suction device according to the pressure value of pressure sensor 50 output. Specifically, the perfusion device sends liquid into the cavity through the channel of endoscope 20, and the suction device is used to extract the waste liquid and calculus in the cavity through the channel of pressure measuring sheath 10 under negative pressure, and the waste liquid and calculus are collected into suction container 91 through negative pressure suction pipe, and the perfusion device cooperates with the suction device to keep the cavity at proper pressure. Exemplarily, the suction device includes 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 is connected with the diaphragm pump and the suction container 91, and the second negative pressure suction pipe 92 is connected with the suction container 91 and the liquid outlet of the pressure measuring sheath 10. The perfusion device includes 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 is communicated 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 enter the renal pelvis through the pressure measuring sheath 10. Optionally, the perfusion pump and the suction pump are installed on the same case 100. 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 host computer can be installed on the endoscope 20 or the image processor 202.

[0049] The following embodiments are based on the existing perfusion suction equipment, which aims to improve the efficiency of stone removal, the pressure measurement accuracy and the operation convenience through the improvement of the sheath tube 102, the endoscope 20, the dilator 60 and the perfusion suction equipment.

[0050] Embodiment 1

[0051] Please refer to Figures 2-13 The pressure measuring sheath 10 provided by the embodiment includes 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 lumen to reach the target area in the body, such as the renal pelvis, and longitudinally extend from the proximal end to the distal end, and the handle is connected to the proximal side of the sheath tube 102 to enable the handle to be kept outside the body.

[0052] The sheath 102 defines at least a first lumen extending longitudinally from a proximal end to a distal end, and the handle includes 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.

[0053] 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 including a passageway therethrough to form a sealed cavity between the first lumen 104 and the body through which a medical instrument can pass.

[0054] 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.

[0055] 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 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 stones 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 will rapidly fluctuate between pressure release and negative pressure by repeatedly and quickly controlling the pressure regulating member 18. The repeated pressure fluctuations can produce a strong suction effect, making it easier to extract the stones and other objects that are adsorbed or stuck. The rapidly changing pressure can generate sufficient impact force to help clear the blockage and ensure the smoothness of the suction passage. By controlling the pressure fluctuations, stronger suction force can be provided when needed, improving the efficiency and success rate of the operation.

[0056] In some embodiments of the utility model, the pressure regulating piece 18 includes a pressure relief valve, the handle body is equipped with a pressure relief cavity 127 communicated with the sheath 102 first lumen 104, the handle body 101 is equipped with a pressure relief valve for sealing or opening the pressure relief cavity 127, in some preferred embodiments of the utility model, the pressure relief cavity 127 is set in the proximal side of the liquid outlet, that is, the path of the pressure relief cavity 127 is not as the discharge path of waste liquid, it is far away from the discharge path of waste liquid, in this way, waste liquid does not pass through the pressure relief cavity 127, and when manually operating the pressure relief valve, liquid will not be contaminated, realizing touchless aseptic operation. In addition, the pressure relief cavity 127 and the pressure relief valve are set on the handle body 101, and the ingeniousness lies in that: when the suction pressure is too large to cause the suction 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 embodiment, the handle body 101 is held, when the pressure relief valve is quickly opened, external air rapidly enters the cavity, the pressure rapidly 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 rapidly drops, forming a negative pressure, which is used for suction;By repeatedly opening and closing the pressure relief valve, the pressure in the cavity will rapidly fluctuate between pressure relief and negative pressure, and the repeated pressure fluctuation can produce a strong suction effect, so that the calculus and other objects adsorbed or stuck are more easily extracted. Exemplarily, the pressure relief valve includes a pressing portion 128, the pressing portion is connected with a pressure relief hose (pressure relief cavity 127), a 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. Exemplarily, the pressing portion is connected with the pressure relief pipe, pressing the pressing portion can adjust the opening degree and closing of the valve thereon, and then adjust the volume of external air entering the first lumen.

[0057] In an 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 main body. At least one data connector 52 is arranged on the PCB board 51. The data connector 52 extends from the handle main body 101. The data connector 52 is adapted to be connected to external infusion and suction equipment. Further, the handle main body 101 is provided with an operation button 54. The user controls the operation button 54 to control the operation of infusion and suction. Specifically, the operation button 54 is located at the upper part of the handle main body 101 to control the operation of infusion and suction. The pressure regulating part 18 is also arranged at the upper part. In this way, the upper part of the handle main body 101 constitutes an operation area. The handle can realize the operations of 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 part 18 are both arranged at the upper part. During operation, the handle does not need to be frequently moved. The user only needs to operate the handle main body 101 at the upper part with fingers. 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 in one. The doctor no longer needs to switch or coordinate multiple devices. The user can complete multiple functions by operating one handle, which reduces the complexity of operation.

[0058] The PCB board 51 is arranged at the middle position of the handle main body 101. This optimizes the internal space layout, making the shape and weight distribution of the handle main body 101 more reasonable. The handle main 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 main body 101 is provided with a finger ring 109. In this way, the bottom of the handle main body 101 is provided with a finger ring 109, and the operation surface is located at the top surface of the handle main body 101. Such a design is in line with ergonomics, ensuring that the user can maintain a natural and comfortable grip 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. This can not only hold the handle firmly, but also use other fingers flexibly for operation. The operation surface at the top of the handle main body 101 is more convenient for the fingers to touch, and the operation is more convenient and fast. The arrangement of the finger ring 109 makes the center of gravity of the handle more stable, and the weight is 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 main 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.

[0059] In the embodiment of the utility model, the bottom end of the sheath tube 102 is provided with a liquid outlet, the bottom end here refers to the end facing the ground, that is, 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 piece 120 is arranged at the liquid outlet, and the other end extends out of the handle main body 101, and the axis of the first channel defined by the first connecting piece is perpendicular to the axis of the sheath tube 102. In this way, compared with discharging waste liquid through the inclined side arm led out of the sheath tube 102, the utility model forms a straight discharge path for discharging waste liquid, and the waste liquid directly flows into the first connecting piece 120 through the bottom end of the sheath tube 102, and 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 piece 120 is directly connected with the liquid outlet and there is no 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 piece is arranged below the handle main body 101 instead of the side part, so that the operation of the doctor is not disturbed by the negative pressure suction device, thereby further improving the smoothness and accuracy of the operation.

[0060] 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, and 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 the rubber sealing ring is located in the handle main body 101 and is connected to the proximal end of the sheath tube. The rubber sealing ring is used for sealing penetration of the elongated dilator 60 or the catheter of the endoscope 20. Specifically, the proximal end of the handle main body 101 is provided with a pressing part, 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, so that the pressure is stabilized.

[0061] In addition, the proximal end of 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 the rotation of the dilator 60 during cooperation with the sheath, facilitate operation and improve efficiency.

[0062] In one example of the utility model, the distal end of the sheath tube 102 is a flexible section 136 that can bend, and the endoscope 20 includes an operating part and a bending part. 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.

[0063] Embodiment 2

[0064] On the basis of embodiment 1, the utility model further provides a pressure measuring sheath which can detect the pressure in the body, such as the pressure in the renal pelvis, a pressure measuring cavity 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 cavity 105 is arranged side by side with the first cavity 104, a pressure measuring port for sensing the liquid pressure in the body is arranged at the distal end of the pressure measuring cavity 105, the handle comprises a second connecting piece 124 arranged on the handle body, the second connecting piece 124 has a second channel in communication with the pressure measuring cavity 105, a pressure sensor is arranged on the pressure measuring cavity 105, the second channel or any path in communication therewith, and all of them can collect the pressure data of the pressure measuring cavity. Exemplarily, the pressure sensor 50 can be arranged at the distal end of the endoscope 20, can be arranged at the distal end of the pressure measuring sheath 10, can be arranged in the pressure measuring cavity 105 in the pressure measuring sheath 10, or can be arranged at any position on the pressure measuring path in communication with the pressure measuring cavity 105, such as an external device, and the positions herein include but are not limited to the second connecting piece 124 in communication with the pressure measuring cavity 105.

[0065] Further, in the embodiment, the pressure sensor 50 is installed on the inner side or the outer side of the second channel. In the embodiment, the outer wall of the second channel is provided with a pressure measuring hole 126, 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 cavity 105. It almost does not occupy the space of the second channel, and the second channel 124 can also be used as other auxiliary cavities, so as to avoid resource occupation by other instruments. It can be understood that the detection signal of the pressure sensor 50 can be connected with external equipment through a connecting line to transmit and process the signal and the like.

[0066] In some embodiments of the utility model, 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 in communication with the outside for communication, so as to facilitate the 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 in communication 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 cavity, and the second channel has an opening in communication with the outside, the opening can be opened or closed through a sealing part, for example, a second sealing cap 125, and the calibration of the pressure sensor 50 is realized through the opening and the calibration chamber 103.

[0067] 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.

[0068] In the present embodiment, the pressure sensor 50 is located in the handle main body 101 for electrical connection with the PCB board 51. The data connector 52 is used to connect with external devices such as the main control machine, perfusion device, suction device, display device, etc. to realize the transmission of pressure signal and control of perfusion and suction operation state.

[0069] 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, due to the pressing operation of the operation button or other operations of the handle, the pressure change in the sealed calibration chamber 103 in the handle main body 101 will cause 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 sensor 50 from reducing the pressure measurement precision caused by the pressure fluctuation in the handle main body 101. 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 pipe cavity 105 is realized, while the system stability and operation simplicity are ensured.

[0070] As mentioned before, the distal end of the pressure sensing pipe 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 pipe 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 and not in communication with the first pipe cavity 104, i.e. the outer wall of the pressure sensing pipe cavity 105 is opened to form the pressure sensing port. This type of 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 can easily enter the pressure sensing pipe cavity through the outer pressure sensing port, and the pressure sensing precision will decrease after the pressure sensing pipe 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, and the measured value is relatively low compared with 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 opening of the inner wall and the opening 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 relatively high, and the cavity pressure can be truly fed back, but there is also the risk of pipe blockage. Or the opening of the inner wall and the opening 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 relatively high, and the cavity pressure can be truly fed back, and there is no risk of pipe blockage. 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.

[0071] In some embodiments of the utility model, the proximal end of the sheath tube 102 is provided with a pressure relief hole 130, which is suitable for being in communication with the outside to facilitate the entry of air. When the sheath tube 102 is placed into operation through an instrument or the like, pressure fluctuation will be caused, and the stability of the cavity pressure can be ensured by introducing an appropriate amount of air through the opening of the pressure relief hole 130. 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 utility model, the proximal end of the sheath tube 102 is provided with a sealing element 106, and the endoscope 20 or the dilator 60 is sealingly inserted into the sheath tube 102. The sealing element 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 achieve small-amplitude pressure relief. Alternatively, the sheath tube 102 comprises a sealing element 106 and an elongated sheath tube, the sealing element 106 has a valve port, the sealing element 106 is connected to the proximal end of the sheath tube, the valve port is used for sealingly penetrating the elongated dilator 60 or the endoscope 20, the proximal end of the handle body 101 is provided with a pressing element, the pressing element comprises a pressing part 133 which is pressed above the sealing element 106 and a rotating part 134 which is rotationally connected to the handle body 101, the sealing element 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 and the upper pressure relief hole 130 are communicated to realize pressure stabilization.

[0072] Embodiment 3

[0073] 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 will flow towards 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, 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 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 amount of 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.

[0074] 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 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, and then generate an impact force on the stones, gradually reducing the adhesion and static friction between the stones and the surrounding tissues. 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 of a single channel, and solving the technical problem that the stones are difficult to be effectively sucked due to excessive perfusion pressure.

[0075] 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.

[0076] Embodiment 4

[0077] 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 causes the pressure signal to be difficult to be transmitted 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. Exemplarily, the pressure measuring pressure P of the pressure sensor 50 is 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.

[0078] Based on this, in some embodiments of the utility model, the pressure measuring sheath 10 further comprises a tension eliminating mechanism to eliminate the influence of water film on intracavity pressure detection

[0079] As described 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 pipe 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. Exemplarily, 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 P 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 P4 of the high-frequency pulse carbon dioxide gas. Exemplarily, the second connecting piece 124 is connected to the carbon dioxide gas pump 71 interface through the connecting pipe 70.

[0080] In addition, the second connecting piece 124 is provided with a one-way valve 74 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 plugging the second sealing cap 125, foreign matter and water column will re-enter the pressure measuring tube cavity 105, and the second sealing cap 125 will be pressed to enter air, causing pressure difference in the pressure measuring tube cavity 105, combined with the influence of water film, causing pressure measuring accuracy to decline, and the use of 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.

[0081] 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 P measured by the pressure measuring module P = P3 = P1. Reduce the retention of water film, improve the self-cleaning ability and measurement accuracy of the pressure measuring tube cavity 105.

[0082] The present 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 improves the measurement accuracy and stability of the system,

[0083] Embodiment 5

[0084] 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.

[0085] 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 Figure 17 .

[0086] 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 in the radial direction, 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.

[0087] 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.

[0088] In other embodiments, please refer to Figure 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.

[0089] 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 difficulty of operation and the pressure change of the pressure measuring 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 measuring port, so as to facilitate the smooth extraction of the dilator from the sheath tube.

[0090] 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.

[0091] In the 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, a signal line 82 is arranged in the pressure measuring lumen to transmit a 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 act 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 temperature and pressure, and through the principle of resistance change and pressure difference, accurate data acquisition and transmission are realized.

[0092] 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, so as to avoid accidental extrusion or misfire of the sensor by laser energy instruments.

[0093] The resistance sensor 80 transmits signals through the signal line 82 arranged in the pressure measuring lumen.

[0094] 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.

[0095] 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 these 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. A guide device, characterized in that The guide device comprises The pressure measuring sheath comprises a handle and a sheath tube, the sheath tube is sized and shaped to enter a target area in a body through a body lumen, and longitudinally extends from a proximal end to a distal end, the sheath tube defines a first lumen for an external instrument to enter, and a pressure measuring lumen longitudinally extends in the sheath tube from the proximal end to the distal end, the pressure measuring lumen is provided with a pressure measuring port at the distal end for sensing a pressure of a liquid in the body, the pressure measuring port is in communication with the outside and the first lumen, and the pressure measuring lumen or any position on a path in communication therewith is provided with a pressure sensor; The handle comprises a handle body and a first connector provided on the handle body, the handle body defines a port in communication with the first lumen, the port is provided with a sealing member, the sealing member comprises a passage therethrough to form a sealed cavity between the first lumen and the body after a medical instrument passes through the passage, and the first connector has a first channel in communication with the first lumen to form a drainage path, and the first connector is adapted to be connected with a negative pressure device to drain the liquid medium in the body out of the body through the drainage path. The dilator is provided with a blocking portion for limiting the foreign matter to enter the pressure measuring lumen through the pressure measuring port.

2. The guide device of claim 1, wherein, The dilator is provided with a blocking portion for limiting the foreign matter to enter the pressure measuring lumen through the pressure measuring port.

3. The guide device of claim 1, wherein, The blocking portion is made of a flexible material to allow the dilator to be withdrawn from the sheath tube.

4. The guide device of claim 3, wherein, The side hole is not less than the diameter of the pressure measuring port.

5. The guide device of claim 2, wherein, The blocking portion is provided with a gap relative to the pressure measuring port.

6. The guide device of claim 3, wherein, The dilator is provided with a blocking portion for limiting the foreign matter to enter the pressure measuring lumen through the pressure measuring port.

7. The guide device of claim 4, wherein, The pressure measuring lumen is provided with a pressure sensor at a position close to the pressure measuring port, and a signal line is arranged in the pressure measuring lumen to transmit a pressure signal.

8. The guide device of claim 1, wherein, The pressure measuring lumen is provided with a protective sleeve in a distal cavity, the pressure sensor is arranged in the protective sleeve, and a sensing portion of the pressure sensor is in communication with the pressure measuring port.

9. The guide device of claim 8, wherein, The pressure sensor is a resistance bridge type sensor, and the protective sleeve is a stainless steel protective sleeve.

10. The guide device of claim 9, wherein, The pressure measuring sheath further comprises:

11. The guide device of claim 1, wherein, A PCB board is arranged in the handle body, the PCB board is provided with at least one data connector configured to be connected with an external perfusion and suction device, and the pressure sensor is connected with the PCB board through a signal line; An operation button is arranged on the handle body and connected with the PCB board to control the operation state of the perfusion and suction. The dilator is provided with a blocking portion for limiting the foreign matter to enter the pressure measuring lumen through the pressure measuring port.

12. A dilator supported for passage within a first lumen of a pressure measuring sheath, characterized by, The dilator is provided with a blocking portion for limiting the foreign matter to enter the pressure measuring lumen through the pressure measuring port.

13. The dilator of claim 12, wherein, The blocking portion is made of a flexible material to allow the dilator to be withdrawn from the sheath tube.

14. The dilator of claim 12, wherein, The side hole is not less than the diameter of the pressure measuring port.

15. The dilator of claim 14, wherein, The blocking portion is provided with a gap relative to the pressure measuring port.

16. The dilator of claim 13, wherein, ​ 17. The dilator of claim 14, wherein, A gap is reserved between the blocking part and the pressure measuring port.

18. The dilator of claim 14, wherein, The outer wall of the dilator is formed with a groove near the blocking part for the blocking part to be retracted into the groove after the blocking part is withdrawn from the pressure measuring port.

Citation Information

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