Pressure measuring sheath for improving pressure measuring precision and guiding device

Abstract

The utility model provides a pressure measuring sheath and a guiding device for improving pressure measuring precision, the pressure measuring sheath comprises a sheath tube and a handle, the pressure measuring sheath comprises a handle main body and a first connecting piece arranged on the handle main body, the handle main body defines a port communicated with a first tube cavity, the port is provided with a sealing piece, and the sealing piece is connected with the first tube cavity. The sealing piece comprises a passage penetrating through the sealing piece so that a sealing cavity can be formed between the first pipe cavity and the body after the medical instrument penetrates through the passage, the first connecting piece is provided with a first channel, and the first channel is communicated with the first pipe cavity to form a drainage path. The first connecting piece is suitable for being connected with a negative pressure device so that a liquid medium in the body can be discharged out of the body through the liquid discharging path. The tension eliminating mechanism is used for eliminating the detection influence of the water film on the pressure in the cavity.

Description

Technical Field

[0001] This utility model relates to medical devices, specifically to a pressure measuring sheath and guiding device for improving pressure measurement accuracy. Background Technology

[0002] In conventional ureteroscopic lithotripsy, stone powder and hematuria in the renal pelvis can obscure the field of vision, necessitating irrigation to maintain a clear view. However, this rapid irrigation and poor reflux can significantly increase intrarenal pelvic pressure, allowing infected urine, bacteria, and endotoxins to enter the bloodstream and lymphatic system. This can lead to postoperative fever, systemic inflammatory response syndrome, and even fatal urosepsis. To prevent serious infections caused by excessively high renal pelvic pressure during flexible ureteroscopy, it is crucial to control the intrarenal pelvic pressure within a safe range. Furthermore, it is necessary to adjust the irrigation rate and / or negative pressure suction value based on the intraoperative renal pelvic pressure feedback. The ability of the pressure measurement method to accurately and in real-time measure renal pelvic pressure is fundamental to ensuring the performance of the pressure measurement and control system and the safety of the surgical procedure.

[0003] The ureteral manometry sheath 10 is mainly used clinically to establish a surgical access point for ureteral stricture, adhesions, obstruction, blockage, and stones requiring related surgical treatment. This access point is used to insert an endoscope 20, laser fiber, stone retrieval instruments, or manipulation cables. Meanwhile, in current urological surgeries, irrigation fluid is needed to maintain a clear field of vision. However, the intrarenal pelvic pressure can significantly increase due to rapid irrigation and poor reflux. To prevent complications such as fever and renal pelvic rupture caused by changes in intrarenal pressure, it is necessary to control the intrarenal pelvic pressure within a safe range during surgery.

[0004] Existing flexible pressure-measuring sheaths retain the pressure-measuring lumen, with the sensor and pressure control module placed on the main control unit or its tubing. Pressure is then transmitted to the sensor via a connecting tube to the pressure-measuring lumen of the sheath. However, this structure suffers from poor pressure measurement accuracy due to significant tubing interference. Furthermore, the operation buttons are located on the main unit, making it inconvenient for doctors to control the procedure and hindering their ability to focus on the lithotripsy and stone removal processes while simultaneously controlling the irrigation and suction procedures. Alternatively, some solutions mount the pressure sensor on the pressure-measuring sheath or endoscope, with the pressure control module located on the main unit or its tubing, connected via cables. This structure also suffers from poor operability, and the accuracy of pressure measurement is not always guaranteed. Summary of the Invention

[0005] This invention provides a pressure-sensing sheath, the pressure-sensing sheath comprising:

[0006] A sheath, sized and shaped to enter a target area within the body through a body lumen, and extending longitudinally from a proximal end to a distal end, defines a first lumen suitable for the entry of external instruments, and forms a pressure-measuring lumen extending longitudinally from the proximal end to the distal end within the sheath wall, a pressure-measuring port for sensing intra-body fluid pressure is provided on the distal side of the pressure-measuring lumen, and a pressure sensor for detecting intra-body pressure is provided at any location on the pressure-measuring lumen or along a path connected to it;

[0007] A handle includes a handle body and a first connector disposed on the handle body. The handle body defines a port communicating with a first lumen. The port is provided with a seal. The seal includes a passage through which a medical device passes to form a sealed cavity between the first lumen and the body. 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.

[0008] Tension relief mechanism, used to eliminate the influence of water film on the detection of pressure inside the cavity.

[0009] In some embodiments, the handle body is provided with an air inlet pipe that communicates with the pressure measuring chamber, the air inlet pipe allowing high-frequency, low-pressure gas from the outside to enter the pressure measuring chamber to eliminate the water film.

[0010] In some embodiments, the handle includes a second connector disposed on the handle body, the second connector having a second channel communicating with a pressure measuring chamber, a pressure sensor being disposed on the pressure measuring chamber, the second channel, or any path communicating therewith, and the second connector constituting an air intake pipe.

[0011] In some embodiments, the sheath is sealed to the handle body to construct a calibration chamber within the handle body. The calibration chamber is open to the outside. A PCB board and a pressure sensor are installed in the calibration chamber. The pressure sensor is a gauge pressure sensor. The outer wall of the second channel has a pressure measuring hole that communicates with the calibration chamber. The gauge pressure sensor is positioned in the chamber, and at least its sensing diaphragm is located at the pressure measuring hole to collect the pressure in the pressure measuring chamber. The second channel has an opening that is open to the outside. The opening can be opened or closed by a sealing part. The calibration of the pressure sensor is achieved by cooperating with the calibration chamber through the opening.

[0012] In some embodiments, the second connector is provided with a one-way valve to allow gas to enter the pressure measuring chamber only from the outside in one direction. Preferably, the gas is high-frequency micro-pressure carbon dioxide.

[0013] In some embodiments, the surface of the inner wall of the pressure measuring lumen, at least at its distal end, is coated with a hydrophilic or hydrophobic coating.

[0014] In some embodiments, the end of the second connector extending from the handle forms an opening, which can be sealed or opened by a sealing part.

[0015] In some embodiments, the pressure-sensing sheath further comprises:

[0016] A PCB board is installed inside the handle body. The PCB board is connected to a pressure sensor. The PCB board has at least one data connector that extends from the handle and is configured to be connected to external infusion and suction devices.

[0017] The operation buttons are located on the handle body and connected to the PCB board to control the infusion and aspiration operation.

[0018] The present invention further provides a guiding device, the guiding device comprising:

[0019] As described above, the pressure-measuring sheath

[0020] An expander, which is supported and inserted into the first lumen to facilitate the entry of the pressure measuring sheath into the body, is provided with a blocking part to prevent foreign objects from entering the pressure measuring lumen through the pressure measuring port.

[0021] In some embodiments, a cavity is formed inside the expander, and the sidewall of the cavity has a side hole communicating with the pressure measuring port, through which foreign objects can enter and exit the cavity.

[0022] In some embodiments, the expander is provided with a sealing portion that can block the pressure measuring port at the distal end of the pressure measuring cavity to restrict foreign objects from entering the pressure measuring cavity.

[0023] This embodiment effectively eliminates the influence of water film on pressure detection by introducing multiple measures such as high-frequency low-pressure gas, coating treatment, and one-way valves, significantly improving measurement accuracy and system stability.

[0024] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0025] The above and / or additional aspects and advantages of the present invention will become apparent and readily understood from the description of the embodiments taken in conjunction with the following drawings, in which:

[0026] Figure 1 This is a schematic diagram of the perfusion system involved in the pressure-measuring sheath provided by the present invention;

[0027] Figure 2 A schematic diagram illustrating the principle of the pressure-measuring sheath provided in an embodiment of the present invention;

[0028] Figure 3 A schematic diagram of the structure of the pressure-sensing sheath (with expander) provided by the present invention;

[0029] Figure 4 This is a partial structural schematic diagram of the pressure-measuring sheath (with expander) of the present invention;

[0030] Figure 5 A structurally disassembled schematic diagram of the pressure-sensing sheath (with expander) provided by the present invention;

[0031] Figure 6 This is a cross-sectional view of the pressure measuring sheath provided by the present invention;

[0032] Figure 7 This is a side view of the structure of the pressure measuring sheath provided by the present invention;

[0033] Figure 8 This is a cross-sectional view of the pressure measuring sheath provided by the present invention;

[0034] Figure 9 This is a schematic diagram of the distal end of the pressure-measuring sheath (with expander) provided by the present invention;

[0035] Figures 10-13 A schematic diagram of the pressure measuring port provided by this invention;

[0036] Figure 14 This is a schematic diagram of the pressure sheath pumping carbon dioxide according to the present invention;

[0037] Figures 15-16 This is a schematic diagram illustrating the pressure detection principle of the pressure measuring sheath provided by the present invention;

[0038] Figures 17-18 This is a cross-sectional view of the distal end of the pressure-measuring sheath provided by the present invention;

[0039] Figure 19 This is a cross-sectional view of the cable structure provided by the present invention;

[0040] Figure 20 This is a schematic diagram of the structure of the sheath (with a sensor configured at the distal end) provided by the present invention.

[0041] in,

[0042] 10-Pressure measuring sheath, 11-Data connector, 20-Endoscope, 200-Endoscope catheter

[0043] 101-Handle body, 102-Sheath, 103-Calibration chamber, 104-First cavity, 105-Pressure measuring cavity, 106-Seal, 107-Pressure measuring port, 108-Port, 109-Finger ring, 120-First connector, 121-Third connector, 122-First sealing cap, 123-Auxiliary cavity, 124-Second connector, 125-Second sealing cap, 126-Pressure measuring hole, 127-Pressure relief chamber, 18-Pressure regulating component, 128-Pressing part, 130-Pressure relief hole, 131-Switch, 132-First connector, 133-Pressure pressing part, 134-Rotating part, 135-Restricting part, 136-Flexible section, 138-Valve;

[0044] 50-Pressure sensor, 51-PCB board, 52-Data connector, 521-Wire core, 522-Insulating outer sheath, 53-Connector, 54-Operating button, 55-Exhaust pipe;

[0045] 60-Expander, 601-Second connection, 602-Expander cavity, 605-Groove, 603-Side hole, 604-Blocking part, 70-Connecting pipe, 71-Carbon dioxide pump, 73-Hydrophilic or hydrophobic coating, 74-One-way valve;

[0046] 80 - Resistor bridge sensor, 81 - Stainless steel sleeve, 82 - Signal line;

[0047] 90-First negative pressure suction tube, 91-Suction container, 92-Second negative pressure suction tube, 93-Liquid storage container, 94-Inlet tube, 95-Outlet tube, 100-Chassis, 201-Endoscope wiring harness, 202-Image processor. Detailed Implementation

[0048] In the description of this invention, it should be understood that the terms "front", "rear", "head", "tail", "far", "near", "axial", and "radial" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting this invention.

[0049] In the description of this invention, it should be noted that, unless otherwise specified and limited, the terms "installation" and "connection" should be interpreted broadly. For example, they can refer to mechanical or electrical connections, or internal connections between two components. They can be direct connections or indirect connections through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms according to the specific circumstances.

[0050] Please see Figure 1This invention provides an infusion and aspiration system, which includes a pressure-measuring sheath 10, an endoscope 20, an infusion device, an aspiration device, a pressure detection component, and a main control unit. The endoscope 20 is inserted into the pressure-measuring sheath 10 to observe the renal pelvis. The infusion device uses a liquid medium to pressurize and expand the patient's internal cavity to form a visible area and to clean impurities within the cavity, allowing the doctor to have a clear view and surgical field through the endoscope 20. The aspiration device is used to suction waste fluid from the patient's internal cavity. The pressure detection component includes a pressure sensor 50, which is used to detect the intracavitary pressure within the renal pelvis. The pressure detection component, the infusion device, and the aspiration device are connected to the main control unit, which controls the flow rate and pressure of the infusion device and the aspiration device based on the pressure value output by the pressure sensor 50. Specifically, the perfusion device delivers liquid into the cavity through the channel of the endoscope 20, and the suction device is used to extract waste fluid and stones from the cavity through the channel of the pressure measuring sheath 10 under negative pressure. The waste fluid and stones are collected into the suction container 91 through the negative pressure suction tube. The perfusion device and the suction device cooperate to maintain the cavity at a suitable pressure. Exemplarily, the suction device includes a diaphragm pump, a first negative pressure suction tube 90, a suction container 91, and a second negative pressure suction tube 92. The first negative pressure suction tube 90 connects the diaphragm pump and the suction container 91, and the second negative pressure suction tube 92 connects the suction container 91 and the outlet of the pressure measuring sheath 10. The perfusion device includes a storage container 93 and a perfusion pump. The perfusion pump is connected to the storage bag through an inlet pipe 94; the perfusion pump is connected to the delivery channel through an outlet pipe 95. It is understood that the liquid medium can enter the renal pelvis through the endoscope 20 or through the pressure measuring sheath 10. Optionally, the infusion pump, suction pump, and main control unit are integrated and installed in the same chassis 100. Specifically, the infusion pump is a peristaltic pump, and the suction pump is a diaphragm pump. Furthermore, the endoscope is connected to the image processor 202 via the endoscope wiring harness 201, and the main control unit can be installed on the endoscope 20 or on the image processor 202.

[0051] The following implementation methods are all based on existing infusion and suction equipment, and aim to improve stone removal efficiency, pressure measurement accuracy and ease of operation by improving the sheath 102, endoscope 20, dilator 60 and infusion and suction equipment.

[0052] Example 1

[0053] Please see Figures 2-13 The pressure measuring sheath 10 provided in this embodiment includes a handle and an elongated sheath 102. The handle is a handle that an adult user can grip. The user can hold the handle with one hand to operate the pressure measuring sheath 10 flexibly. The size and shape of the sheath 102 are suitable for entering the target area of ​​the body, such as the renal pelvis, through the body lumen and extend longitudinally from the proximal end to the distal end. The handle is connected to the proximal side of the sheath 102 so that the handle can be kept outside the body.

[0054] The sheath 102 defines at least a first lumen extending longitudinally from the proximal end to the 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 the user.

[0055] The handle body 101 defines a port 108 communicating with the first lumen 104. A seal 106 is disposed at the port 108. The seal 106 includes a passage through which a medical device passes to form a sealed cavity between the first lumen 104 and the body after passing through the passage.

[0056] The first connector 120 has a first channel, which communicates with the first lumen to form a drainage path. The first connector 120 is adapted to be connected to a negative pressure device so that the liquid medium in the body is discharged out of the body through the drainage path. For example, the first connector 120 can be a Luer connector, etc. The Luer connector is connected to the suction device. After the waste liquid passes through the first lumen 104 and the first connector 120, it enters the collection container of the suction device.

[0057] Please see Figure 8 The handle body 101 is further provided with a pressure regulating component 18, which is used to adjust the pressure of the first lumen. Thus, when excessive suction pressure causes excessive pressure within the renal pelvis, resulting in organ collapse, air can be quickly introduced through the pressure regulating component 18 to rapidly release pressure and ensure the continuation of the surgery. In some preferred embodiments of the present invention, the pressure regulating component 18 is connected to the first lumen and positioned away from the drainage path, i.e., the pressure regulating component 18 is far from the waste fluid drainage path. This prevents contact with liquid during manual operation of the pressure regulating component 18, achieving contactless and aseptic operation. Furthermore, the ingenious aspect of providing a pressure regulating component 18 on the handle body 101 is that when excessive suction pressure causes stone aspiration to fail, the user needs to manually increase the suction force. Based on the pressure regulating component 18 provided in this embodiment, by holding the handle body 101 and repeatedly and rapidly controlling the pressure within the pressure regulating component 18, the pressure will fluctuate rapidly between depressurization and negative pressure. This repeated pressure fluctuation can generate a strong suction effect, making it easier to remove adsorbed or stuck stones and other objects. Rapidly changing pressure can generate sufficient impact force to help clear blockages and ensure unobstructed suction channels. By controlling pressure fluctuations, stronger suction can be provided when needed, improving the efficiency and success rate of the procedure.

[0058] In some embodiments of the present invention, the pressure regulating component 18 includes a pressure relief valve. The handle body is provided with a pressure relief chamber 127 communicating with the first cavity 104 of the sheath 102. The handle body 101 is provided with a pressure relief valve for sealing or opening the pressure relief chamber 127. In some preferred embodiments of the present invention, the pressure relief chamber 127 is located near the liquid outlet, that is, the path of the pressure relief chamber 127 is not used as the discharge path of the waste liquid, and it is far away from the discharge path of the waste liquid. In this way, the waste liquid does not pass through the pressure relief chamber 127, and the liquid will not be contaminated when the pressure relief valve is manually operated, so aseptic operation without contact is achieved. Furthermore, the ingenious design of the pressure relief chamber 127 and pressure relief valve on the handle body 101 is as follows: when excessive suction pressure causes the stone suction to fail, the user needs to manually increase the suction force. Based on the pressure relief chamber 127 and pressure relief valve provided in this embodiment, when the handle body 101 is held and the pressure relief valve is quickly opened, outside air quickly enters the chamber, and the pressure rises rapidly, achieving the pressure relief effect; when the pressure relief valve is quickly closed, the suction device continues to work, and the pressure inside the chamber drops rapidly, forming a negative pressure for suction; by repeatedly and quickly opening and closing the pressure relief valve, the pressure inside the chamber will fluctuate rapidly between pressure relief and negative pressure. The repeated pressure fluctuations can produce a strong suction effect, making it easier to remove stones and other objects that are adsorbed or stuck. For example, the pressure relief valve includes a pressing part 128 connected to a pressure relief hose (pressure relief chamber 127). An openable and closable valve 138 is formed on the pressure relief hose (pressure relief chamber 127). Thus, the user controls the opening and closing of the valve 138 by pressing the pressing part 128. For example, the pressing part is connected to a pressure relief pipe, and pressing the pressing part can adjust the opening and closing of its valve, thereby adjusting the volume of outside air entering the first chamber.

[0059] In one embodiment of the present invention, the guide sheath further includes a PCB board 51 and an operation button 54. The PCB board 51 is disposed within the handle body, and at least one data connector 52 is provided on the PCB board 51. The data connector 52 extends from the handle body 101 and is suitable for connection to external infusion and suction devices. Furthermore, the handle body 101 is provided with the operation button 54, allowing the user to control the infusion and suction operations. Specifically, the operation button 54 is located on the upper part of the handle body 101 for controlling the infusion and suction operation. The pressure regulating component 18 is also located on the upper part. Thus, the upper part of the handle body 101 constitutes the operation area, enabling operations such as infusion, suction, pressure release, and increased suction force. All these operations can be completed with the fingers, greatly simplifying the usage process. Since both the operation button 54 and the pressure regulating component 18 are located on the upper part, frequent handle movement is unnecessary; only the fingers need to operate on the upper part of the handle body 101. This reduces the range of hand movement and improves operational efficiency. Compared to traditional designs that require simultaneous control of multiple devices, this invention integrates multiple control functions into one. Doctors no longer need to switch or coordinate multiple devices; they can perform multiple functions simply by operating a single handle, which reduces operational complexity.

[0060] A PCB board 51 is positioned in the middle of the handle body 101, optimizing the internal space layout and making the shape and weight distribution of the handle body 101 more reasonable. The handle body 101 is designed to be more ergonomic, increasing user comfort. In some examples of this invention, a finger ring 109 is provided at the bottom of the handle body 101, so that the operating surface is located on the top surface of the handle body 101. This design is ergonomic, ensuring that the user can maintain a natural and comfortable grip posture during operation. The finger ring 109 provides an additional support point, helping the user to grip the handle more stably and reducing hand muscle fatigue. Due to the presence of the finger ring 109, the user can pass one finger through the finger ring 109, which allows for a stable grip while also enabling flexible use of other fingers. The operating surface at the top of the handle body 101 is more easily accessible to the fingers, making operation simpler and faster. The finger ring 109 makes the handle's center of gravity more stable, distributing weight more evenly when gripping the handle, thus improving operating comfort. The ring 109 makes the handle more stable, preventing it from slipping or rotating during operation, thus improving precision and control. Combined with these improvements, the ring 109 design makes the handle body 101 more compatible with user habits and needs, significantly enhancing the user experience, especially in scenarios requiring prolonged holding and precise operation.

[0061] In an embodiment of the present invention, the bottom end of the sheath 102 is provided with a liquid outlet. Here, "bottom end" refers to the end facing the ground. The design of the bottom outlet utilizes gravity to allow waste liquid and stones to flow downwards, enhancing discharge efficiency. One end of the first connector 120 is located at the liquid outlet, and the other end extends out of the handle body 101. The axis of the first channel defined by the first connector is perpendicular to the axis of the sheath 102. Thus, compared to discharging waste liquid through an inclined side arm extending from the sheath 102, the present invention forms a straight discharge path for waste liquid, flowing directly into the first connector 120 through the bottom end of the sheath 102. This straight path reduces the resistance encountered by the liquid and stones in the channel, lowering the risk of blockage. Since the first connector 120 is directly connected to the liquid outlet, there are no bends in the pipe, and the waste liquid and stones do not need to change their flow direction during discharge. This design significantly reduces the probability of stones lingering and getting stuck in the pipe. Furthermore, by placing the first connector below the handle body 101 rather than on the side, the doctor's operation is not interfered with by the negative pressure suction device, further improving the smoothness and accuracy of the operation.

[0062] In this embodiment, a first connecting portion 132 adapted for detachable connection with a dilator 60 is provided at port 108 of the handle body 101. The dilator 60 has a handle portion and a slender catheter. The first connecting portion 132 is adapted for detachable connection with a second connecting portion 601 of the handle portion of the dilator 60. Specifically, the first connecting portion 132 and the second connecting portion 601 are snap-fitted together. A rubber sealing ring (106) is connected to a slender sheath. The rubber sealing ring is located inside the handle body 101 and connected to the proximal end of the sheath. The rubber sealing ring allows the slender dilator 60 or the endoscope 20 catheter to pass through in a sealed manner. Specifically, the handle body 101 has a pressing component near its end. The pressing component includes a pressing part 133 that presses against the rubber valve and a rotating part 134 that rotates with the handle body 101. The rubber sealing ring has a lower pressure relief hole 130 and the pressing cover has an upper pressure relief hole 130. By rotating the rotating ring, the pressing cover is rotated so that the lower pressure relief hole 130 communicates with the upper pressure relief hole 130, thus achieving pressure stabilization.

[0063] In addition, the near end of the handle body 101 is provided with a limiting part 135 to prevent the expander 60 from coming out, so as to limit the expander 60 from rotating out during use with the sheath, which facilitates operation and improves efficiency.

[0064] In one example of the present invention, the distal end of the sheath 102 is a flexible segment 136 that can be bent, and the endoscope 20 includes an operating part and a bending part, wherein the operating part can drive the bending part to bend; the endoscope 20 is inserted in the sheath 102, the bending part is housed in the flexible segment 136, and the bending part can drive the flexible segment 136 to bend.

[0065] Example 2

[0066] Based on Embodiment 1, the present invention further provides a pressure-measuring sheath capable of detecting pressure within the body, such as within the renal pelvis. The sheath wall forms a pressure-measuring lumen 105 extending longitudinally from the proximal end to the distal end. The pressure-measuring lumen 105 is separated from and arranged side-by-side with a first lumen 104. A pressure-measuring port for sensing intra-body fluid pressure is provided on the distal side of the pressure-measuring lumen 105. The handle includes a second connector 124 disposed on the handle body. The second connector 124 has a second channel communicating with the pressure-measuring lumen 105. Pressure sensors are disposed on the pressure-measuring lumen 105, the second channel, or any path communicating with it, all capable of collecting pressure data from the pressure-measuring lumen. For example, the pressure sensor 50 can be located at the distal end of the endoscope 20, at the distal end of the pressure measuring sheath 10, in the pressure measuring lumen 105 inside the pressure measuring sheath 10, or at any location on the pressure measuring path connected to the pressure measuring lumen 105, such as on an external device. This location includes, but is not limited to, the second connector 124 connected to the pressure measuring lumen 105.

[0067] Furthermore, in this embodiment, the pressure sensor 50 is installed on the inner or outer side of the second channel. In this embodiment, the outer wall of the second channel is provided with a pressure measuring hole 126, and the pressure sensor 50 is disposed on the inner side of the handle body, with at least its sensing part disposed at the pressure measuring hole 126 to sense the pressure of the pressure measuring cavity 105. It occupies almost no space in the second channel, and the second channel 124 can also be used as other auxiliary cavities, avoiding resource encroachment with other instruments. It is understood that the detection signal of the pressure sensor 50 can be connected to external devices via a connecting cable for signal transmission and processing, etc.

[0068] In some embodiments of the present invention, the pressure sensor 50 is a gauge pressure sensor. The sheath 102 is sealed to the handle body 101 to construct a calibration chamber 103 within the handle body. The calibration chamber 103 is connected to the outside for communication to facilitate calibration and adjustment of the pressure sensor 50. The calibration chamber 103 houses the PCB board 51 and the pressure sensor 50. 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 its sensing diaphragm is disposed at the pressure measuring hole 126 to collect the pressure within the pressure measuring chamber. The second channel has an opening that is connected to the outside. The opening can be opened or closed by a sealing part, such as a second sealing cap 125. The calibration of the pressure sensor 50 is achieved by cooperating with the calibration chamber 103 through the opening.

[0069] Specifically, the working principle of the gauge pressure sensor is to determine the pressure value by measuring the pressure change of the fluid or gas on the sensor's sensing diaphragm. This value is then compared with the ambient pressure to obtain the relative pressure. If the pressure at the measuring point is higher than atmospheric pressure, the sensor outputs a positive value; if it is lower than atmospheric pressure, it outputs a negative value or zero. When the pressure measuring sheath is not inside the body, the pressure measuring port 107 at the distal end of the pressure measuring sheath 10 is connected to the calibration chamber 103, thus calibrating the gauge pressure sensor. When the pressure measuring sheath is inside the body, the second sealing cap 125 is opened, opening the second channel to the outside, at which point it cooperates with the calibration chamber 103 to calibrate the gauge pressure sensor. Furthermore, installing the gauge pressure sensor inside the handle body 101, compared to installing it externally in a main control unit or other similar location, reduces the volume of the pressure measuring chamber, allows for a faster and more accurate response to pressure changes, avoids signal attenuation and lag in large spaces, and results in higher accuracy.

[0070] In this embodiment, the pressure sensor 50 is located inside the handle body 101 to facilitate electrical connection with the PCB board 51, and the data connector 52 is used to connect with external devices such as a main controller, infusion device, suction device, and display device to realize the transmission of pressure signals and control of the infusion and suction operation status.

[0071] Please see Figure 19 The data connector 52 (including a wire core 521 and an insulating outer sheath 522) has an exhaust pipe 55 connecting the outside world to the handle body 101, thereby enabling communication between the calibration chamber inside the handle body and the outside world. Furthermore, since pressing the operation button or other operations on the handle can cause pressure changes within the sealed calibration chamber 103 inside the handle body 101, leading to sensor misalignment, the exhaust pipe design eliminates pressure fluctuations caused by the operation button 54, maintaining pressure stability within the handle body 101 and preventing a decrease in the pressure measurement accuracy of the pressure sensor 50 due to pressure fluctuations within the handle body 101. Through the rational layout of the pressure sensor 50 and its auxiliary equipment, combined with the design of the sealed chamber and exhaust pipe 55, accurate pressure monitoring of the pressure measuring chamber 105 is achieved, while ensuring system stability and ease of operation.

[0072] As mentioned above, the distal end of the pressure-measuring lumen 105 has a pressure-measuring port 107, which is adapted to sense the pressure inside the human body cavity and transmit it to the pressure-measuring lumen. The pressure-measuring port can be configured in various ways; for example, please refer to... Figure 10 The pressure measuring port 107 is connected to the outside but not to the first cavity 104. That is, the outer wall of the pressure measuring cavity 105 is opened to form a pressure measuring port. This externally connected pressure measuring channel is connected to the high-pressure area inside the cavity, providing high measurement accuracy and accurate feedback of the cavity pressure. However, foreign objects can easily enter the pressure measuring cavity through the outer pressure measuring port, and the measurement accuracy decreases after the pressure measuring cavity is blocked. For another embodiment, please refer to... Figure 11The pressure measuring port 107 is connected to the first cavity 104 but not to the outside. That is, the inner wall of the pressure measuring cavity 105 is opened to form a pressure measuring port. This port is connected to the low-pressure area within the cavity, so the measured value will be relatively lower than the overall pressure within the cavity, but this eliminates the risk of foreign objects blocking the pressure measuring cavity. In another embodiment, please refer to... Figure 12 and Figure 13 The pressure measuring port 107 is connected to both the outside and the first cavity 104. In this case, both the inner and outer walls of the pressure measuring cavity 105 have openings. In this embodiment, the openings on the inner and outer walls are radially aligned, and the fully-connected pressure measuring channel simultaneously connects to both the high-pressure and low-pressure areas within the cavity, resulting in high measurement accuracy and accurate feedback of the cavity pressure. However, this also carries the risk of blockage. Alternatively, the openings on the inner and outer walls can be staggered, for example, in a Z-shape. The Z-shaped pressure measuring port simultaneously connects to both the high-pressure and low-pressure areas within the cavity, providing high measurement accuracy, accurate feedback of the cavity pressure, and eliminating the risk of blockage. More preferably, the distal end of the pressure measuring cavity 105 is located near the distal end of the first cavity. The distal end of the pressure measuring cavity is provided with a pressure measuring port that connects to both the outside and the first cavity; that is, the distal end of the pressure measuring cavity is not the same as the distal end of the first cavity, and the pressure measuring port connects to both the outside and the first cavity.

[0073] In some embodiments of the present invention, the proximal end of the sheath 102 provided by the present invention is provided with a pressure relief hole 130. The pressure relief hole 130 is adapted to communicate with the outside to allow air to enter. When the sheath 102 is inserted by instruments or the like, pressure fluctuations may occur. By opening the pressure relief hole 130 to introduce an appropriate amount of air, the stability of the internal pressure is ensured. This avoids pressure fluctuations caused by external operations and improves pressure measurement accuracy. It is 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 when necessary to alleviate excessive internal pressure. In embodiments of the present invention, the proximal end of the sheath 102 is provided with a sealing element 106, and the endoscope 20 or dilator 60 is sealed and inserted into the sheath 102. The sealing element 106 is provided with a pressure relief hole 130, and the pressure relief hole 130 is provided with a switch to open or close the pressure relief hole 130, solving the influence of pressure fluctuations caused by instrument insertion, etc., on pressure detection and achieving small-amplitude pressure relief. Optionally, the sheath 102 includes a seal 106 and an elongated sheath. The seal 106 has a valve port and is connected to the proximal end of the sheath. The valve port allows the elongated dilator 60 or endoscope 20 to pass through in a sealed manner. The proximal end of the handle body 101 is provided with a pressing member. The pressing member includes a pressing part 133 pressing on the seal 106 and a rotating part 134 rotatingly engaging with the handle body 101. The seal 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 pressing part 133 is rotated by the rotation of the rotating ring so that the lower pressure relief hole 130 communicates with the upper pressure relief hole 130 to achieve pressure stabilization.

[0074] Example 3

[0075] In some embodiments of the present invention, dual-channel perfusion is utilized, where the flow of fluid between different channels is affected by pressure differences. Liquid in high-pressure areas flows towards low-pressure areas, while low-pressure areas attract more fluid. When the endoscope 20 enters the sheath 102, waste fluid is aspirated out of the body through the first lumen 104 of the sheath 102, and liquid enters the body through the endoscope 20 catheter. With this aspiration and suction, when the negative pressure aspiration pressure within the sheath 102 is very high, the pressure inside the sheath 102 is much lower than the pressure inside the endoscope 20. This significant pressure difference leads to more fluid entering the body, resulting in excessive perfusion volume and excessively high perfusion pressure in localized areas, making it difficult to aspirate waste fluids such as stones.

[0076] Based on this, the handle body 101 provided in this embodiment is provided with a third connector 121. The third connector 121 can be sealed by a first sealing cap 122. When liquid delivery is required, the first sealing cap 122 is opened; when not needed, the first sealing cap 122 is closed to avoid affecting the negative pressure. The sheath 102 has an auxiliary cavity 123 isolated from the first cavity 104 and the pressure measuring cavity 105. The third connector 121 communicates with the auxiliary cavity 123. The third connector 121 and the auxiliary cavity 123 form a liquid inlet channel for the infusion liquid medium to enter. In this way, the infusion liquid enters the body through the third connector 121 and the auxiliary cavity 123, generating small pressure fluctuations. This creates a dynamic pressure environment around the stone, promoting the loosening and movement of the stone. The pressure fluctuations periodically change the flow rate and direction of the liquid, thereby generating an impact force on the stone and gradually reducing the adhesion and static friction between the stone and the surrounding tissues. In addition, the introduction of auxiliary lumen 123 provides more liquid inlet paths, ensuring a stable supply of liquid medium, avoiding pressure instability caused by uneven liquid supply from a single channel, and solving the technical problem that stones are difficult to be effectively aspirated due to excessive injection pressure.

[0077] Optionally, the inner diameter of the second channel 124 and the third connector 121 is larger than the inner diameter of the pressure measuring cavity 105 and the auxiliary cavity 123, thus facilitating the entry of external instruments.

[0078] Example 4

[0079] A water film easily forms at the pressure measuring port 107 at the distal end of the pressure measuring cavity 105. This water film formation makes it difficult to transmit the pressure signal to the pressure sensor 50 in a timely and accurate manner, hindering real-time pressure detection. Furthermore, the water film tension causes a deviation between the signal transmitted to the pressure sensor 50 and the actual pressure signal, thus affecting the accuracy of the measurement. For example, the pressure measured by the pressure sensor 50 is P = P3 = P1 + P2, where P1 is the pressure inside the cavity, P2 is the water film tension, and P3 is the pressure inside the pressure measuring cavity 105.

[0080] Based on this, in some embodiments of the present invention, the pressure measuring sheath 10 further includes a tension relief mechanism to eliminate the influence of the water film on the detection of intracavity pressure.

[0081] As mentioned above, please refer to Figure 14 The handle body 101 is provided with a first connector 124 communicating with the pressure measuring chamber 105. The first connector 124 has an opening, which can be sealed or opened by a second sealing cap 125. The first connector 124 constitutes an air inlet pipe to allow high-frequency, low-pressure gas from the outside to enter and eliminate the water film. Since the pressure sensor 50 does not occupy the space of the first connector 124, the first connector 124 can be used as other auxiliary chambers, improving the space utilization efficiency of the pressure measuring sheath 10. This effectively eliminates the interference of the water film on the signal transmission of the pressure sensor 50, ensuring timely and accurate transmission of the pressure signal. For an example, please refer to [link to example]. Figure 15 The second sealing cap 125 of the second channel 124 is opened, and a high-frequency, low-pressure gas, such as carbon dioxide, is supplied to the second channel 124 to break the water film tension balance formed by the liquid in the cavity at the distal port 108 of the pressure measuring tube 105. At this time, the pressure measured by the pressure measuring module is P = P3 + P4 = P1 + P2 (when the water film tension balance is broken, P4 = P2, P = P3 = P1), where P1 is the cavity pressure, P2 is the water film tension, P3 is the pressure inside the pressure measuring tube 105, and P4 is the high-frequency pulsed carbon dioxide gas pressure P4. Exemplarily, the second connector 124 is connected to the carbon dioxide pump 71 interface via a connecting pipe 70.

[0082] Furthermore, a one-way valve 74 is provided at the second connector 124 to allow only gas to be pumped into the pressure measuring chamber 105 from the outside, thus eliminating the pressure accuracy decrease caused by water film tension. If the one-way valve 74 is not provided, after the second sealing cap 125 is plugged, foreign objects and water columns will re-enter the pressure measuring chamber 105, and the closing of the second sealing cap 125 will force air in, causing a pressure difference in the pressure measuring chamber 105. Combined with the effect of the water film, this will cause a decrease in pressure measuring accuracy. Using the one-way valve 74 can prevent water in the chamber from flowing back into the pressure measuring chamber 105 after air is pumped in, thereby improving pressure measuring accuracy.

[0083] In other embodiments, please refer to Figure 16 The inner wall of the pressure measuring cavity 105 is provided with a hydrophilic or hydrophobic coating 73. The water film tension can be regarded as non-contact with the pressure measuring cavity 105. At this time, the pressure measured by the pressure measuring module is P=P3=P1. This reduces the retention of water film and improves the self-cleaning ability and measurement accuracy of the pressure measuring cavity 105.

[0084] This embodiment effectively eliminates the influence of water film on pressure detection by introducing multiple measures such as high-frequency low-pressure gas, coating treatment, and one-way valves, significantly improving measurement accuracy and system stability.

[0085] Example 5

[0086] When the pressure measuring sheath 10 (typically used in surgical procedures such as catheter insertion) enters the body cavity, negative pressure aspiration and irrigation have not yet begun. At this time, the dilator 60 has already 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 for foreign objects to enter the pressure measuring lumen 105, causing blockage of the pressure measuring lumen 105 and a sharp decrease in pressure measuring accuracy.

[0087] The expander 60 is provided with a blocking part to prevent foreign objects from entering the pressure measuring chamber 105 through the pressure measuring port 107. Please refer to [link / reference]. Figure 17 .

[0088] In some embodiments of the present invention, the pressure measuring port 107 is connected to both the outside and the first cavity. In this case, both the inner and outer walls of the pressure measuring cavity have openings, with the openings of the inner wall and outer wall radially corresponding. That is, the distal end of the pressure measuring cavity is not the same as the distal end of the first cavity, and the pressure measuring port connects to both the outside and the first cavity. The expander 60 forms a cavity inside, and the sidewall of the cavity has a side hole 603 communicating with the pressure measuring port 107 at the distal end of the pressure measuring cavity 105. Foreign objects can enter through the side hole 603 of the expander 60 and exit through the cavity.

[0089] The side hole 603 is not smaller than the diameter of the pressure measuring port 107. The diameter of the side hole 603 of the dilator 60 is not smaller than the diameter of the pressure measuring port 107, ensuring that foreign objects can pass smoothly through the side hole 603 and be discharged from the cavity, preventing the pressure measuring lumen 105 from being blocked, and improving the safety and convenience of the surgical operation.

[0090] In other embodiments, please refer to Figure 18 The expander 60 is provided with a sealing portion 60 that can block the distal pressure measuring port 107 of the pressure measuring cavity 105 to restrict foreign objects from entering the pressure measuring cavity 105. Thus, when the expander 60 is pulled out of the sheath 102 after entering the cavity, foreign objects are prevented from being introduced into the pressure measuring cavity 105, ensuring the unobstructed flow and pressure measuring accuracy of the pressure measuring cavity 105. For example, the sealing portion 60 is made of a flexible material to allow the expander 60 to be withdrawn from the sheath 102. The use of a flexible material for the sealing portion 60 allows the expander 60 to be smoothly withdrawn from the sheath 102 during use, avoiding operational inconvenience and potential damage that may be caused by rigid materials.

[0091] A gap is provided between the sealing part 60 and the pressure measuring port 107. This appropriate gap ensures effective sealing while avoiding operational difficulties and pressure changes in the pressure measuring chamber 105 caused by excessive sealing. A groove 605 is formed on the outer wall of the expander near the sealing part so that the sealing part can retract into the groove after exiting the pressure measuring port, facilitating the smooth extraction of the expander from the sheath.

[0092] By providing a blocking part and a sealing part 60 on the expander 60, the problem of foreign objects entering the pressure measuring tube 105 during the process of the pressure measuring sheath 10 entering the body cavity, causing blockage and a decrease in pressure measuring accuracy, is solved.

[0093] In this embodiment, please refer to Figure 20 A pressure sensor 50 is installed near the pressure measuring port in the pressure measuring cavity 105. A signal line 82 is installed inside the pressure measuring cavity to transmit pressure signals. The pressure sensor 50 is a resistance bridge sensor 80, and this sensor is placed at the distal end of the sheath. Temperature acts on the sensor surface, causing a change in the resistance of the temperature measuring bridge arm, thus generating a pressure difference. Simultaneously, gas and liquid pressures act on the sensor surface, causing micro-strain in the sensor, which in turn causes a change in the resistance of the pressure measuring bridge arm, generating a pressure difference. Then, the two sets of voltage signals are converted into digital signals by an internal acquisition unit, and finally, the data is read out through the SPI interface. In this way, the resistance bridge sensor can measure both temperature and pressure, achieving accurate data acquisition and transmission through the principle of resistance change and pressure difference.

[0094] A protective sleeve is provided in the distal cavity of the pressure measuring tube 105. The resistance bridge sensor 80 is installed in the protective sleeve, and the sensing surface of the resistance bridge sensor 80 is connected to the pressure measuring port 107 at the distal end of the pressure measuring tube 105. It is preferable to use a stainless steel protective sleeve for protection to avoid accidental squeezing of the sensor or accidental impact from energy devices such as lasers.

[0095] The resistive sensor 80 transmits signals through a signal line 82 located inside the pressure measuring chamber.

[0096] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "illustrative embodiment," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0097] Although embodiments of the invention have been shown and described, those skilled in the art will understand that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the claims and their equivalents.

Claims

1. A pressure-measuring sheath, characterized in that, The pressure-sensing sheath includes A sheath, sized and shaped to enter a target area within the body through a body lumen, and extending longitudinally from a proximal end to a distal end, defines a first lumen suitable for the entry of external instruments, and forms a pressure-measuring lumen extending longitudinally from the proximal end to the distal end within the sheath wall, a pressure-measuring port for sensing intra-body fluid pressure is provided on the distal side of the pressure-measuring lumen, and a pressure sensor for detecting intra-body pressure is provided at any location on the pressure-measuring lumen or along a path connected to it; A handle includes a handle body and a first connector disposed on the handle body. The handle body defines a port communicating with a first lumen. The port is provided with a seal. The seal includes a passage through which a medical device passes to form a sealed cavity between the first lumen and the body. 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. Tension relief mechanism, used to eliminate the influence of water film on the detection of pressure inside the cavity.

2. The pressure-measuring sheath according to claim 1, characterized in that, The handle body is provided with an air inlet pipe that communicates with the pressure measuring chamber. The air inlet pipe allows high-frequency, low-pressure gas from the outside to enter the pressure measuring chamber to eliminate the water film.

3. The pressure-measuring sheath according to claim 2, characterized in that, The handle includes a second connector disposed on the handle body. The second connector has a second channel communicating with the pressure measuring chamber. A pressure sensor is disposed on the pressure measuring chamber, the second channel, or any path communicating with it. The second connector constitutes an air intake pipe.

4. The pressure-measuring sheath according to claim 3, characterized in that, The sheath is sealed to the handle body to form a calibration chamber within the handle body. The calibration chamber is open to the outside. A PCB board and a pressure sensor are installed in the calibration chamber. The pressure sensor is a gauge pressure sensor. The outer wall of the second channel has a pressure measuring hole that communicates with the calibration chamber. The gauge pressure sensor is positioned in the chamber, and at least its sensing diaphragm is located at the pressure measuring hole to collect the pressure in the measuring chamber. The second channel has an opening that is open to the outside. The opening can be opened or closed by a sealing part. The pressure sensor is calibrated by cooperating with the calibration chamber through the opening.

5. The pressure-measuring sheath according to claim 3, characterized in that, The second connector is equipped with a one-way valve to allow gas to enter the pressure measuring chamber from the outside only in one direction. Preferably, the gas is high-frequency micro-pressure carbon dioxide.

6. The pressure-measuring sheath according to claim 1, characterized in that, The pressure measuring cavity has at least one end of its inner wall coated with a hydrophilic or hydrophobic coating.

7. The pressure-measuring sheath according to claim 3, characterized in that, The second connector extends out of the handle to form an opening, which can be sealed or opened by a sealing part.

8. The pressure-measuring sheath according to claim 1, characterized in that, The pressure-measuring sheath further includes: A PCB board is installed inside the handle body. The PCB board is connected to a pressure sensor. The PCB board has at least one data connector that extends from the handle and is configured to be connected to external infusion and suction devices. The operation buttons are located on the handle body and connected to the PCB board to control the infusion and aspiration operation.

9. A guiding device, characterized in that, The guidance device includes: The pressure-measuring sheath as described in any one of claims 1-8, An expander, which is supported and inserted into the first lumen to facilitate the entry of the pressure measuring sheath into the body, is provided with a blocking part to prevent foreign objects from entering the pressure measuring lumen through the pressure measuring port.

10. The guiding device according to claim 9, characterized in that, The expander has a cavity formed inside, and the sidewall of the cavity has a side hole that communicates with the pressure measuring port. Foreign objects can enter through the side hole of the expander and be discharged from its cavity.

11. The guiding device according to claim 10, characterized in that, The expander is equipped with a sealing part that can block the pressure measuring port at the far end of the pressure measuring cavity to restrict foreign objects from entering the pressure measuring cavity.

Images