A flexible ureteroscope sheath device and its pressure control method

Abstract

This invention relates to the field of medical device technology and discloses a ureteroscope sheath device and its pressure control method. The device includes: a connector tube seat connected to the sheath at one end, and three connectors at the other end: a first connector connecting to a pressure relief device and a control device, a second connector for flexible endoscope and irrigation, and a third connector for negative pressure suction; a central channel inside the sheath, with axially uniformly arranged pressure sensors around the channel; the control device includes adjustment buttons, a digital display, indicator lights, and a buzzer, and is electrically connected to the pressure sensors and the pressure relief device; the control device includes an automatic pressure relief module for collecting analog voltage signals and converting them into pressure data values. When the detected value reaches a set threshold, the electrically controlled pressure relief device automatically releases pressure. This invention achieves real-time, continuous detection and control of intracavitary pressure.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to a ureteroscope sheath device and its pressure control method. Background Technology

[0002] The ureteral guiding sheath is a commonly used auxiliary device in urology, primarily used to provide a stable passage and reduce surgical risks when flexible endoscopes or other instruments enter the ureter. In clinical practice, to maintain a good surgical field, continuous instillation of fluid into the renal pelvis and ureteral lumen is usually necessary. However, continuous instillation can easily lead to increased intraluminal pressure. When the pressure is too high, it may cause complications such as hydronephrosis, renal parenchymal damage, and retrograde infection, and in severe cases, even endanger the patient's safety. Therefore, how to monitor and effectively control intraluminal pressure in real time during surgery is an important clinical concern.

[0003] For example, CN211751716U discloses a ureteral guide sheath with pressure measurement and control functions. This type of device can achieve the basic function of "pressure measurement and control": when the pressure indicator shows that the intraluminal pressure is too high, the doctor can manually or automatically release the pressure using a valve, or even use a negative pressure device to assist in lowering the pressure, thereby reducing the risk of complications. However, the following problems still exist: the pressure measurement method relies on mechanical structure and can only provide interval display, unable to perform high-precision, real-time data monitoring; the pressure control function has a delayed response, relying mostly on the opening and closing of mechanical valves or manual intervention, making it difficult to control pressure changes in a timely and accurate manner; the early warning mechanism is insufficient, and when the pressure continues to rise, the device lacks audible, visual, or data interface prompts, which may cause the doctor to miss the best intervention opportunity.

[0004] Therefore, it is necessary to design a flexible ureteroscope sheath device and its pressure control method to solve the problems existing in the current technology. Summary of the Invention

[0005] In view of this, the present invention proposes a flexible ureteroscope sheath device and its pressure control method, aiming to solve the problem of inaccurate pressure control within the renal pelvis and ureteral lumen.

[0006] In one aspect, the present invention provides a flexible ureteroscope sheath device, comprising: a multi-channel connector tube seat, a sheath tube, a pressure relief device, a control device, a flexible endoscope and an irrigation connector, and a negative pressure suction connector;

[0007] The multi-channel connector tube seat is connected to a sheath tube at one end and three connectors at the other end. The first connector is connected to a pressure relief device and a control device, the second connector is a flexible endoscope and infusion connector, and the third connector is a negative pressure suction connector.

[0008] The sheath includes a through-type pressure sensor and a central channel; the through-type pressure sensor is axially and evenly arranged around the central channel;

[0009] The control device includes adjustment buttons, a digital display, indicator lights, and a buzzer; the control device is electrically connected to the pressure relief device and the through-type pressure sensor.

[0010] The control device also includes an automatic pressure relief module. The automatic pressure relief module collects the analog voltage signal of the through-type pressure sensor and converts the analog voltage signal into pressure data value. When the pressure data value is detected to reach the pressure threshold, the automatic pressure relief module electrically controls the pressure relief device to release pressure.

[0011] Furthermore, the automatic pressure relief module also includes a preset unit, a data acquisition unit, a first processing unit, a second processing unit, an output unit, and an early warning unit;

[0012] The preset unit is used to set the initial digital reference value based on the initial output signal of the through-type pressure sensor under ambient atmospheric pressure.

[0013] The acquisition unit is used to monitor the static pressure difference between the inner lumen of the flexible endoscope sheath and the external environment in real time through the through-type pressure sensor, and output an analog voltage signal proportional to the static pressure difference.

[0014] The first processing unit is used to perform impedance matching on the analog voltage signal based on an operational amplifier, and to use low-pass filtering to suppress high-frequency electromagnetic interference and noise caused by the flow of perfusion fluid; and to sample and quantize the analog voltage signal based on an analog-to-digital converter circuit to generate discrete pressure data values ​​in digital form.

[0015] The second processing unit is used to perform moving average filtering on the discrete pressure data values ​​in digital form, and to generate the final pressure data value by accumulating the discrete pressure data values ​​of continuous sampling points and calculating their average value.

[0016] The output unit is used to periodically compare the final pressure data value with the pressure threshold; and generate an on or off control signal based on the result of the periodic comparison.

[0017] The warning unit is used to issue a warning message when the duration of the pressure data value being greater than the pressure threshold is greater than the time threshold.

[0018] Furthermore, when the preset unit sets the initial digital reference value based on the initial output signal of the via-type pressure sensor under ambient atmospheric pressure, it includes:

[0019] The preset unit detects the connectivity between the flexible endoscope sheath and the external environment, confirming that there is no liquid residue in the flexible endoscope sheath and that the pressure is completely balanced with the ambient atmospheric pressure. When the pressure fluctuation amplitude is lower than the fluctuation threshold and remains stable for a certain period of time, the initial analog voltage signal output by the through-type pressure sensor is periodically sampled. The clock module precisely controls the sampling interval for each sampling, collects a preset number of sample points and stores them in a temporary buffer. An arithmetic mean is performed on all sample points in the temporary buffer to eliminate random noise interference and generate the initial digital reference value.

[0020] Furthermore, when the acquisition unit monitors the static pressure difference between the inner lumen of the flexible endoscope sheath and the external environment in real time through the via-type pressure sensor, and outputs an analog voltage signal proportional to the static pressure difference, it includes:

[0021] The via-type pressure sensor is integrated into the fluid passage of the multi-channel connector tube seat, with its sensing diaphragm directly exposed to the perfusion fluid flow within the flexible endoscope sheath. When the pressure within the flexible endoscope sheath changes, the sensing diaphragm of the via-type pressure sensor undergoes physical deformation, driving a change in resistance in its internal piezoresistive sensing element. The via-type pressure sensor converts the resistance change into a differential analog voltage signal output. The signal output terminal of the via-type pressure sensor transmits the analog voltage signal through a shielded wire.

[0022] Furthermore, when the first processing unit performs impedance matching on the analog voltage signal based on the operational amplifier and uses low-pass filtering to suppress high-frequency electromagnetic interference and noise caused by the flow of perfusion fluid, it includes:

[0023] The operational amplifier receives the analog voltage signal output from the channel-type pressure sensor. Impedance matching is achieved by adjusting the adjustable resistor network at its input terminal, ensuring that the input impedance of the operational amplifier is perfectly matched with the output impedance of the sensor, thus eliminating distortion caused by signal reflection. The operational amplifier linearly amplifies the matched analog voltage signal, with the amplification factor dynamically set by a digital potentiometer. The output terminal of the operational amplifier is connected to a resistor-capacitor low-pass filter network, which consists of a series resistor and a parallel capacitor, to filter out high-frequency noise generated by the flow of the perfusion fluid and external electromagnetic interference.

[0024] Furthermore, when the first processing unit samples and quantizes the analog voltage signal based on the analog-to-digital conversion circuit to generate discrete pressure data values ​​in digital form, it includes:

[0025] The timing control unit of the analog-to-digital converter (ADC) generates a precise sampling clock signal, and the sampling frequency is determined by a preset sampling rate parameter. The sample-and-hold module of the ADC captures the instantaneous value of the conditioned analog voltage signal under the trigger of the clock signal and maintains the instantaneous value stable until quantization is completed. The quantizer of the ADC adopts a successive approximation architecture, compares the analog voltage signal with the internal reference voltage, and generates the corresponding discrete pressure data value in digital form through a binary search algorithm.

[0026] Furthermore, when the second processing unit generates the final pressure data value by accumulating the discrete pressure data values ​​of continuous sampling points and calculating their average value, it includes:

[0027] The second processing unit sets a sliding window, the size of which is determined by a preset sampling point number parameter; it calculates the arithmetic sum of all the discrete pressure data values ​​in real time, and divides the arithmetic sum by the window size to obtain the sliding average value, which is used as the final pressure data value.

[0028] Furthermore, when the output unit periodically compares the final pressure data value with the pressure threshold, it includes:

[0029] The final pressure data value is compared with the preset pressure threshold; the comparison period is precisely set through the clock module and repeated within a fixed time interval; the comparison period is dynamically adjusted according to the pressure change rate, automatically shortening or extending the comparison interval.

[0030] Furthermore, when the output unit generates an on / off control signal based on the result of the periodic comparison, it includes:

[0031] When the pressure data value is greater than the pressure threshold, a control signal for driving the pressure relief device to open is generated. The power drive circuit receives the opening control signal, activates the electromagnetic actuator in the pressure relief device, and opens the pressure relief channel, allowing the liquid inside the flexible endoscope sheath to be discharged through the pressure relief channel. When the filtered pressure data is less than the pressure threshold, a control signal for driving the pressure relief device to close is generated. The power drive circuit receives the closing control signal, resets the electromagnetic actuator in the pressure relief device to close the pressure relief channel, and blocks the liquid discharge path inside the flexible endoscope sheath.

[0032] Compared with existing technologies, the advantages of this invention are as follows: Real-time and continuous detection of intra-cavity pressure is achieved through a circumferentially arranged pressure sensor in the central channel of the sheath; combined with an automatic pressure relief module, the pressure relief device can be automatically activated when the pressure exceeds a set threshold, avoiding the risk of excessive intrarenal pressure due to delays caused by manual judgment. Operational amplifier impedance matching and low-pass filtering design suppress high-frequency noise and external electromagnetic interference caused by perfusion fluid flow; combined with a moving average filtering algorithm, discrete sampling points are smoothed, ensuring stable and reliable pressure data and improving measurement accuracy. The analog-to-digital conversion circuit quantizes the analog signal into a digital signal, and combined with dynamic sampling, a sliding window, and a periodic comparison mechanism, achieves digital and intelligent processing of pressure changes. When the pressure data value exceeds the threshold and continues to exceed the timeout, a multi-channel early warning system is automatically triggered, including audible and visual alarms and data interface reminders, preventing doctors from missing the intervention opportunity.

[0033] In another aspect, the present invention proposes a pressure control method for a flexible ureteroscope sheath device, for use with the aforementioned flexible ureteroscope sheath device, comprising:

[0034] The initial digital reference value is set based on the initial output signal of the through-type pressure sensor under ambient atmospheric pressure.

[0035] The static pressure difference between the inner lumen of the flexible endoscope sheath and the external environment is monitored in real time by the aforementioned channel-type pressure sensor, and an analog voltage signal proportional to the static pressure difference is output.

[0036] The analog voltage signal is impedance matched using an operational amplifier, and a low-pass filter is used to suppress high-frequency electromagnetic interference and noise caused by the flow of the perfusion fluid. The analog voltage signal is sampled and quantized using an analog-to-digital converter to generate discrete pressure data values ​​in digital form.

[0037] The discrete pressure data values ​​in digital form are subjected to moving average filtering. The final pressure data values ​​are generated by accumulating the discrete pressure data values ​​of continuous sampling points and calculating their average value.

[0038] The final pressure data value is periodically compared with the pressure threshold; and based on the result of the periodic comparison, an on or off control signal is generated.

[0039] When the duration of the pressure data value being greater than the pressure threshold exceeds the time threshold, an early warning message is issued.

[0040] It is understandable that the aforementioned flexible ureteroscope sheath device and its pressure control method have the same beneficial effects, and will not be elaborated further here. Attached Figure Description

[0041] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the invention. Furthermore, the same reference numerals denote the same parts throughout the drawings. In the drawings:

[0042] Figure 1 This is a schematic diagram of the ureteroscope sheath device provided in an embodiment of the present invention;

[0043] Figure 2 This is a cross-sectional schematic diagram of section A of the ureteroscopic flexible sheath device provided in an embodiment of the present invention;

[0044] Figure 3 A schematic diagram of the control device for the ureteroscopic flexible sheath device provided in an embodiment of the present invention;

[0045] Figure 4 A flowchart of a pressure control method for a ureteroscope sheath device provided in an embodiment of the present invention.

[0046] The components include: 1. Multi-channel connector tube seat; 2. Sheath tube; 21. Path-type pressure sensor; 22. Central channel; 3. Pressure relief device; 4. Control device; 41. Adjustment button; 42. Digital display; 43. Indicator light; 44. Buzzer; 5. Flexible endoscope and infusion connector; 6. Negative pressure suction connector. Detailed Implementation

[0047] Exemplary embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of the present disclosure and to fully convey the scope of the disclosure to those skilled in the art. It should be noted that, unless otherwise specified, embodiments and features in the embodiments of the present invention can be combined with each other. The present invention will now be described in detail with reference to the accompanying drawings and embodiments.

[0048] Current flexible ureteroscopic techniques still have several shortcomings in pressure control. Most traditional flexible ureteroscope sheath devices lack real-time pressure monitoring capabilities, making it difficult for surgeons to accurately monitor the immediate pressure within the renal pelvis or bladder during surgery. This can easily lead to excessively rapid instillation of the infusion fluid or obstructed reflux, resulting in elevated intraluminal pressure. Such excessive pressure can trigger urinary reflux, allowing infectious materials or stone fragments to enter the renal pelvis, increasing the risk of intraoperative and postoperative infection. It can also cause damage to the renal pelvis or ureteral mucosa, potentially leading to short-term or long-term kidney damage. Most pressure relief operations in current techniques rely on manual adjustment. Surgeons must manually open or close the drainage channel based on observation of pressure changes or experience, which not only increases the complexity of the procedure but also makes it difficult to control intraluminal pressure in a timely manner due to operational delays, affecting surgical safety and efficiency.

[0049] For example, in a clinical setting, a patient undergoing ureteroscopic lithotripsy for kidney stones experienced a rapid increase in pressure within the traditional sheath during irrigation. This was due to the large number of stones in the renal pelvis and the high flow rate of the irrigation fluid. The surgeon failed to detect this pressure change in time, causing the pressure to exceed the safe range, resulting in slight reflux and intraoperative bleeding. Postoperatively, the patient developed a mild infection requiring additional antibiotics and a prolonged hospital stay. This example clearly demonstrates the shortcomings of current technology in real-time pressure monitoring and automatic pressure relief, illustrating the potential adverse effects of a lack of intelligent pressure control mechanisms on patient safety and surgical outcomes.

[0050] Therefore, how to achieve real-time monitoring and automatic adjustment of intracavitary pressure during flexible endoscopic surgery, and ensure that the pressure of the renal pelvis and bladder is always maintained within a safe range during the operation, has become an important technical requirement for improving clinical safety and operational efficiency.

[0051] For this, please refer to Figure 1-3 As shown, this application proposes a flexible ureteroscope sheath device, including: a multi-channel connector tube seat 1, a sheath tube 2, a pressure relief device 3, a control device 4, a flexible endoscope and irrigation connector 5, and a negative pressure suction connector 6.

[0052] The multi-channel connector tube seat 1 is connected to the sheath tube 2 at one end and to three connectors at the other end. The first connector is connected to the pressure relief device 3 and the control device 4. The second connector is the flexible endoscope and infusion connector 5. The third connector is the negative pressure suction connector 6.

[0053] The sheath 2 includes a through-type pressure sensor 21 and a central channel 22; the through-type pressure sensor 21 is axially and evenly arranged around the central channel 22;

[0054] The control device 4 includes adjustment buttons 41, a digital display 42, an indicator light 43, and a buzzer 44; the control device 4 is electrically connected to the pressure relief device 3 and the through-type pressure sensor 21 respectively.

[0055] The control device 4 also includes an automatic pressure relief module. The automatic pressure relief module collects the analog voltage signal from the channel-type pressure sensor and converts the analog voltage signal into pressure data value. When the pressure data value is detected to reach the pressure threshold, the automatic pressure relief module electrically controls the pressure relief device 3 to release pressure.

[0056] Specifically, a flexible ureteroscope sheath device is proposed to achieve real-time monitoring and dynamic control of renal pelvis and bladder pressure during surgery. The device mainly includes a multi-channel connector 1, a sheath 2, a pressure relief device 3, a control device 4, a flexible endoscope and irrigation connector 5, and a negative pressure suction connector 6. The flexible endoscope and irrigation connector 5 connects the flexible endoscope to the irrigation channel, ensuring smooth entry of the endoscope into the renal pelvis and enabling continuous irrigation and drainage. The negative pressure suction connector 6 connects to an external negative pressure suction channel, efficiently removing irrigation fluid, stone fragments, and tissue debris during surgery, thus maintaining good surgical field clarity. During the procedure, irrigation fluid is injected into the renal pelvis through the flexible endoscope and irrigation connector 5 and the sheath 2, while irrigation fluid and stone fragments are aspirated through the negative pressure suction connector 6, achieving simultaneous irrigation and suction. If irrigation is too rapid or reflux is impaired, the pressure in the bladder and renal pelvis may increase sharply, causing a synchronous increase in pressure within the flexible endoscope sheath. Therefore, the pressure relief device 3 of this device is configured as an automated control unit: when the static pressure difference between the flexible endoscope sheath and the external environment exceeds 200 mmHg, the pressure relief device 3 will automatically open, rapidly reducing the static pressure difference until it returns to within 200 mmHg, at which point it will automatically close. This dynamic adjustment process ensures that the pressure in the bladder and renal pelvis remains in a relatively safe balance, effectively preventing kidney damage, infection, or postoperative complications caused by excessive pressure. Regarding monitoring and alerts, the device's digital display 42 shows the static pressure difference between the flexible endoscope sheath and the environment in real time, allowing doctors to intuitively monitor the intraoperative pressure. When the static pressure difference exceeds 200 mmHg and the duration exceeds the set threshold, the device will alert the doctor through a double alarm: a flashing indicator light 43 and a buzzer 44. The doctor can then manually intervene using the adjustment buttons to actively initiate pressure relief, further ensuring safety and operational flexibility.

[0057] During the surgical procedure, the surgeon inserts the ureteroscope sheath device into the patient's body through the urethra, ensuring that the sheath 2 is accurately positioned and fixed in the ureter. The flexible endoscope and irrigation connector 5 are connected to the flexible endoscope and irrigation tubing to achieve continuous supply of fluid for the endoscope and irrigation. The negative pressure suction connector 6 is connected to an external negative pressure system for simultaneous aspiration of irrigation fluid and lithotripsy, maintaining a clear field of vision. The sheath's built-in channel-type pressure sensor 21 collects the static pressure difference between the sheath and the external environment in real time, outputting an analog voltage signal, which is converted into a digital pressure value by the control device 4 and displayed on the digital display. If the pressure exceeds the set threshold, the automatic pressure relief module in the control device 4 will immediately activate the pressure relief device 3, releasing excess fluid through the pressure relief channel to quickly reduce the pressure. When the pressure returns to a safe range, the pressure relief device 3 automatically closes to maintain intraluminal stability. Throughout the process, the surgeon can visually monitor pressure changes through the digital display and manually control pressure relief using the adjustment button 41 when necessary. If the abnormal pressure persists, the indicator light 43 will flash and a buzzer 44 will sound an alarm, prompting the surgeon to intervene promptly. This operational procedure organically combines real-time monitoring, automatic control, and manual intervention, ensuring the safety and stability of the surgery.

[0058] As a preferred embodiment, the specific implementation of this application is as follows: A patient undergoes ureteroscopic lithotripsy for kidney stones. The doctor inserts the ureteroscopic sheath device through the urethra, allowing the sheath 2 to smoothly enter the ureter and reach the renal pelvis. During the procedure, the doctor continuously injects irrigation fluid into the sheath through the flexible endoscope and irrigation connector 5 to maintain a clear surgical field, while simultaneously using a negative pressure suction connector 6 to aspirate and drain the irrigation fluid and stone fragments. When there are many stones or the irrigation flow rate is large, the pressure inside the sheath may suddenly increase. If the pressure exceeds 200 mmHg, the through-type pressure sensor 21 inside the sheath will immediately detect the pressure change and transmit an analog electrical signal to the control device 4. The automatic pressure relief module in the control device 4, after data processing, determines that the pressure exceeds the limit and then automatically activates the pressure relief device to quickly drain the excess fluid, restoring the pressure inside the sheath to a safe range. At the same time, the digital display 42 displays the pressure value in real time. If the pressure remains too high for more than a set threshold, the indicator light 43 flashes and the buzzer 44 sounds an alarm, alerting the doctor to potential risks. At this point, doctors can manually intervene by adjusting the buttons, which, in conjunction with automatic pressure relief, can further accelerate pressure recovery.

[0059] Understandably, the ureteroscopic flexible sheath device, by incorporating a via-type pressure sensor 21 within the sheath 2 and combining it with an automatic pressure relief module, achieves real-time monitoring and intelligent control of the static pressure difference between the sheath 2 and the external environment. When the pressure exceeds the safety threshold, the pressure relief device 3 is automatically activated to rapidly reduce the intraluminal pressure, preventing abnormal increases in bladder and renal pelvis pressure caused by excessively rapid infusion or poor reflux. This effectively prevents risks such as urinary reflux, renal pelvis injury, and postoperative infection. The device is equipped with a digital display 42, indicator lights 43, and a buzzer 44, providing intuitive audible and visual alarms in case of abnormal pressure, facilitating timely intervention by physicians. The control device 4 also supports manual adjustment, enhancing the flexibility and safety of clinical operations.

[0060] This application further proposes that the automatic pressure relief module also includes a preset unit, a data acquisition unit, a first processing unit, a second processing unit, an output unit, and an early warning unit;

[0061] The preset unit is used to set the initial digital reference value based on the initial output signal of the through-type pressure sensor under ambient atmospheric pressure.

[0062] The acquisition unit is used to monitor the static pressure difference between the inner lumen of the flexible endoscope sheath and the external environment in real time through a through-type pressure sensor, and outputs an analog voltage signal proportional to the static pressure difference.

[0063] The first processing unit is used to perform impedance matching on the analog voltage signal based on the operational amplifier, and to use low-pass filtering to suppress high-frequency electromagnetic interference and noise caused by the flow of the perfusion fluid; the analog-to-digital conversion circuit samples and quantizes the analog voltage signal to generate discrete pressure data values ​​in digital form.

[0064] The second processing unit is used to perform moving average filtering on the discrete pressure data values ​​in digital form. It generates the final pressure data value by accumulating the discrete pressure data values ​​of continuous sampling points and calculating their average value.

[0065] The output unit is used to periodically compare the final pressure data value with the pressure threshold; and generate an on or off control signal based on the result of the periodic comparison.

[0066] The early warning unit is used to issue an early warning message when the duration of the pressure data value being greater than the pressure threshold exceeds the time threshold.

[0067] Specifically, the pressure control method for the ureteroscopic sheath device involves acquiring an initial output signal at ambient atmospheric pressure using a access-type pressure sensor before the procedure begins. This signal is then set as the initial digital reference value to ensure a reliable reference standard for subsequent pressure monitoring. During the procedure, the access-type pressure sensor monitors the static pressure difference between the lumen of the ureteroscopic sheath and the external environment in real time, converting pressure changes into an analog voltage signal proportional to the static pressure difference. An operational amplifier performs impedance matching on the analog voltage signal to ensure no distortion occurs during signal transmission due to impedance mismatch. Simultaneously, a low-pass filter network suppresses noise caused by high-frequency electromagnetic interference and irrigation fluid flow, ensuring signal accuracy. An analog-to-digital converter samples and quantizes the conditioned analog voltage signal, generating discrete pressure data values ​​in digital form. To reduce the impact of instantaneous fluctuations on the data, a moving average filtering process is performed on these discrete pressure data values. This involves accumulating data from consecutive sampling points and calculating the average value, resulting in a smoother and more reliable final pressure data value. This final pressure data value is periodically compared with a preset pressure threshold. By precisely controlling the comparison period, it is possible to determine in real time whether the pressure exceeds the safe range. If the pressure value exceeds the threshold, an activation control signal will be automatically generated to drive the pressure relief device to drain and release the liquid. When the pressure returns to a safe range, a deactivation control signal will be generated to close the pressure relief device, blocking the liquid discharge path and maintaining stable pressure within the chamber. If the pressure remains above the threshold for an extended period exceeding the set time threshold, a warning message will be issued, prompting the operator to intervene promptly via an audible and visual alarm or a digital display.

[0068] The pressure threshold is used to determine whether the fluid pressure inside the flexible endoscopic sheath exceeds the safe range, and is generally determined based on clinical surgical experience and physiological tolerance limits. For adult urological surgeries, the safe pressure inside the flexible endoscopic sheath is usually controlled at around 200 mmH2O, which is approximately 0.002 MPa. When the pressure value exceeds this threshold, it indicates that the intraluminal pressure may cause stress to the urethra, ureter, or renal pelvis, requiring immediate triggering of pressure relief control. The threshold setting must ensure sufficient irrigation fluid to maintain the surgical field while avoiding excessive pressure that could damage tissues. The threshold can be fine-tuned according to the patient's body size, surgical site, and type of irrigation fluid; for example, it can be set at 150–180 mmH2O for pediatric surgery, and slightly lowered to 180–190 mmH2O for high-risk adult patients to increase the safety margin. The time threshold is used to determine the duration for which the pressure exceeds the threshold, preventing accidental actions caused by brief, momentary pressure fluctuations. It is generally set within ten seconds, such as 5–10 seconds. This time frame is sufficient to filter out brief pressure spikes while ensuring timely pressure relief or warnings during sustained overpressure, preventing tissue damage from prolonged high pressure. The time threshold can also be adjusted based on the type of surgery and perfusion flow characteristics; for example, the time threshold can be appropriately shortened during high-flow perfusion to respond quickly to pressure increases.

[0069] The working process and principle of this application are as follows: Before the operation begins, an initial output signal is collected by a channel-type pressure sensor under ambient atmospheric pressure and set as the initial digital reference value to provide a reference standard for subsequent pressure monitoring. During the operation, the channel-type pressure sensor senses the static pressure difference between the lumen of the flexible endoscope sheath and the external environment in real time and converts the pressure change into an analog voltage signal proportional to the static pressure difference. This signal is first impedance matched by an operational amplifier to eliminate signal distortion caused by the mismatch between the sensor output impedance and the signal receiving impedance. At the same time, a low-pass filter suppresses high-frequency electromagnetic interference and noise generated by the perfusion fluid flow, thereby ensuring the accuracy and stability of the signal. The analog-to-digital conversion circuit samples and quantizes the conditioned analog voltage signal, converting the continuous analog signal into discrete pressure data values ​​in digital form. To further reduce the impact of instantaneous fluctuations on the data, these discrete data are subjected to moving average filtering, that is, the data of continuous sampling points are accumulated within a set window and the average value is calculated to generate a smooth and reliable final pressure data value. By periodically comparing the final pressure data value with a preset pressure threshold, it is determined in real time whether the pressure in the flexible endoscope sheath exceeds the safe range. If the pressure exceeds the threshold, an activation control signal is generated, driving the pressure relief device to automatically drain fluid and relieve pressure, reducing the intracavitary pressure. When the pressure returns to a safe range, a deactivation control signal is generated, closing the pressure relief device and blocking the drainage pathway, thereby maintaining stable intracavitary pressure. If the pressure data value continuously exceeds the threshold for a set time period, an audible and visual alarm or digital prompt will be issued, alerting the physician to intervene promptly to prevent excessive pressure in the bladder and renal pelvis, which could lead to reflux, tissue damage, or other complications. Through closed-loop control involving real-time acquisition, signal conditioning, data processing, and automatic regulation, precise management of intracavitary pressure during flexible endoscopic surgery is achieved, improving surgical safety and operational efficiency while reducing the physician's workload.

[0070] As a preferred embodiment, the solution of this application is implemented as follows: During a cystoscopy, the physician uses a flexible ureteroscope sheath to fragment stones in the renal pelvis. Before the procedure begins, an initial output signal is acquired at ambient atmospheric pressure using a access-type pressure sensor and set as the initial digital reference value to ensure the accuracy of subsequent pressure monitoring. During the fragmentation process, the physician continuously injects saline solution into the renal pelvis through the flexible endoscope and irrigation connector to flush the fragments, while simultaneously aspirating the fragments and irrigation fluid to the outside through a negative pressure suction connector. As the flow rate of the injected fluid increases, the pressure in the renal pelvis and bladder gradually rises. The access-type pressure sensor monitors the static pressure difference between the lumen of the flexible endoscope sheath and the external environment in real time and outputs an analog voltage signal proportional to the pressure change. This analog voltage signal is impedance matched by an operational amplifier to eliminate signal attenuation and distortion caused by the mismatch between the sensor output impedance and the downstream receiving circuit. Simultaneously, a low-pass filter is used to suppress high-frequency noise generated by the flow of irrigation fluid and environmental electromagnetic interference. The analog-to-digital converter performs high-frequency sampling and quantization on the processed signal, converting the analog signal into discrete digital pressure data. Short-term fluctuations are then eliminated through moving average filtering, generating a stable and reliable final pressure value. The final pressure value is continuously compared periodically with a preset safety threshold. When the pressure approaches or exceeds the threshold, an automatic control signal is generated to activate the pressure relief device, reducing intracavitary pressure. When the pressure returns to a safe range, the pressure relief pathway is closed to maintain pressure stability. If the intrarenal pelvis pressure continuously exceeds the threshold for more than 3 seconds, a warning value is displayed on the digital monitor, an indicator light flashes, and a buzzer sounds an alarm, reminding the doctor to pay attention to the operation and prevent excessive pressure from causing reflux or tissue damage. The doctor can adjust the perfusion rate appropriately or manually open the pressure relief pathway based on the prompts to maintain a dynamic balance between the pressure in the renal pelvis and bladder.

[0071] Understandably, a pressure sensor with a via path collects the static pressure difference signal between the flexible endoscope sheath and the external environment. This signal is then processed by operational amplifier impedance matching and low-pass filtering to eliminate signal interference and noise, ensuring the stability and accuracy of the pressure data. An analog-to-digital converter samples and quantizes the processed analog signal to generate discrete digital pressure data. This data is then processed by a moving average filter to obtain the final pressure value. By periodically comparing this value with a preset pressure threshold, an automatic opening or closing control signal is generated to drive the pressure relief device to regulate the pressure inside the flexible endoscope sheath. When the pressure remains above the safety threshold for an extended period, an audible and visual warning is issued to alert the physician to take intervention measures, thereby preventing tissue damage or intraoperative complications caused by excessive pressure in the renal pelvis and bladder.

[0072] This application further proposes that when the preset unit sets the initial digital reference value based on the initial output signal of the through-type pressure sensor under ambient atmospheric pressure, it includes:

[0073] The communication status between the inner lumen of the flexible endoscope sheath and the external environment is detected to confirm that there is no liquid residue in the inner lumen of the flexible endoscope sheath and that the pressure is completely balanced with the ambient atmospheric pressure. After the pressure fluctuation amplitude is lower than the fluctuation threshold and remains stable for a certain period of time, the initial analog voltage signal output by the through-type pressure sensor is periodically sampled. The sampling interval is precisely controlled by its clock module, a preset number of sample points are collected and stored in a temporary buffer. An arithmetic mean is performed on all sample points in the temporary buffer to eliminate random noise interference and generate an initial digital reference value.

[0074] Specifically, the initial digital reference value is set by first ensuring the fluid intubation is free of liquid residue and that the internal pressure is completely balanced with atmospheric pressure by checking the connectivity between the flexible endoscope sheath and the external environment, thus eliminating the influence of external interference factors on the measurement. After confirming pressure stability, the pressure fluctuation amplitude is monitored. Once the pressure fluctuation is below a preset fluctuation threshold and remains stable for a set duration, the initial analog voltage signal acquisition process of the through-type pressure sensor is initiated. During sampling, the clock module precisely controls the time interval of each sampling to ensure the continuity and timing accuracy of data acquisition, while a preset sampling number ensures statistical reliability. All acquired sample points are stored in a temporary buffer. An arithmetic mean is calculated on all sample points in the buffer to effectively eliminate random noise and transient interference, generating a high-precision, stable, and reliable initial digital reference value. This reference value not only provides a reference point for subsequent pressure monitoring within the flexible endoscope sheath but also provides an accurate basis for the automatic pressure relief module to judge pressure deviations and trigger control signals.

[0075] As a preferred embodiment, the specific implementation of this application is as follows: Before performing ureteroscopic lithotripsy, medical staff place the flexible ureteroscope sheath in an external cavity environment to ensure that there is no residual infusion fluid in the sheath lumen and that the intracavitary pressure is completely balanced with the ambient atmospheric pressure. After activation, the access-type pressure sensor begins to monitor the intracavitary pressure. When the pressure fluctuation amplitude is less than the preset 5 mmHg threshold and remains stable for at least 10 seconds, the sensor's initial analog voltage signal is periodically sampled. The clock module precisely controls the sampling interval to be 50 milliseconds, collecting a total of 100 sample points, which are then stored in a temporary buffer. An arithmetic mean is calculated on all sample points in the buffer to eliminate occasional electromagnetic interference or minor fluctuations, generating a stable and reliable initial digital reference value.

[0076] Understandably, by precisely measuring the inner cavity of the flexible endoscope sheath under ambient atmospheric pressure, it is ensured that there is no liquid residue and the pressure is completely balanced, thus providing reliable initial conditions for pressure monitoring. When the pressure fluctuation is below a preset threshold and remains stable, the through-type pressure sensor periodically samples the initial analog voltage signal with high precision. The collected sample points are stored in a temporary buffer with the interval strictly controlled by a clock module. An arithmetic mean is performed on all sample points in the buffer to eliminate occasional noise and interference, generating a stable and reliable initial digital reference value.

[0077] This application further proposes that when the acquisition unit monitors the static pressure difference between the inner lumen of the flexible endoscope sheath and the external environment in real time through a via-type pressure sensor, and outputs an analog voltage signal proportional to the static pressure difference, it includes:

[0078] The channel-type pressure sensor is integrated into the fluid passage of the multi-channel connector tube seat, and its sensing diaphragm is directly exposed to the perfusion fluid flow inside the flexible endoscope sheath. When the pressure inside the flexible endoscope sheath changes, the sensing diaphragm of the channel-type pressure sensor undergoes physical deformation, driving the internal piezoresistive sensing element to generate a resistance change. The channel-type pressure sensor converts the resistance change into a differential analog voltage signal output. The signal output terminal of the channel-type pressure sensor transmits the analog voltage signal through a shielded wire.

[0079] Specifically, a channel-type pressure sensor is integrated into the fluid passageway within the multi-channel connector, with its sensing diaphragm directly exposed to the perfusion fluid flow within the flexible endoscope sheath. During surgery, changes in the perfusion fluid flow or the pressure within the sheath cause minute physical deformation of the sensing diaphragm, which is converted into a resistance change by an internal piezoresistive sensing element. The sensor's internal circuitry further converts these resistance changes into a differential analog voltage signal, making the output signal proportional to the static pressure difference between the sheath and the external environment. To ensure signal stability and interference resistance, the sensor's output uses shielded wires to transmit the analog voltage signal, effectively isolating it from external electromagnetic interference and noise. This design allows surgeons to monitor pressure changes within the flexible endoscope sheath in real-time, continuously, and accurately, providing reliable data support for the pressure control module and ensuring timely triggering of the pressure relief device for automatic or manual adjustment under high pressure conditions.

[0080] As a preferred embodiment, the solution of this application is implemented as follows: A channel-type pressure sensor is integrated into the fluid passage of the inner wall of the multi-channel connector tube, and its sensing diaphragm is directly exposed to the perfusion fluid injected into the renal pelvis through the sheath. When the perfusion fluid flow rate suddenly increases or backflow obstruction occurs during the surgical procedure, the pressure inside the flexible endoscope sheath increases accordingly, causing physical deformation of the sensing diaphragm and driving a change in resistance in the internal piezoresistive sensing element. These resistance changes are converted into differential analog voltage signals by the internal circuit of the sensor and transmitted to the control device through shielded wires. After receiving the signal, the control device can calculate the static pressure difference between the inner cavity and the external environment in real time, and when the pressure exceeds a set threshold, it triggers the automatic pressure relief module to start the pressure relief device, draining excess fluid and rapidly reducing the pressure inside the sheath to ensure the safety of the renal pelvis and bladder. This real-time monitoring and response mechanism can effectively prevent tissue damage or operational inconvenience caused by excessive pressure during surgery.

[0081] Understandably, by integrating a channel-type pressure sensor into the fluid pathway within the multi-channel connector tube, and directly exposing its sensing diaphragm to the perfusion fluid flow within the flexible endoscope sheath, the static pressure difference between the sheath and the external environment can be monitored in real time and accurately. When the pressure within the sheath changes, the sensor diaphragm undergoes physical deformation, driving a change in resistance in the internal piezoresistive sensing element. This resistance change is converted into a differential analog voltage signal by the sensor's internal circuitry and transmitted to the control device via shielded wires. This enables continuous, real-time monitoring of the pressure within the sheath, allowing the pressure control system to respond quickly to pressure anomalies and automatically adjust the pressure relief device, thereby preventing excessively high pressure in the renal pelvis and bladder due to excessively rapid perfusion or poor reflux during surgery.

[0082] This application further proposes that when the first processing unit performs impedance matching on the analog voltage signal based on an operational amplifier and uses low-pass filtering to suppress high-frequency electromagnetic interference and noise caused by the flow of perfusion fluid, it includes:

[0083] The operational amplifier receives the analog voltage signal output from the via-type pressure sensor. Impedance matching is achieved by adjusting the adjustable resistor network at its input terminal, ensuring that the input impedance of the operational amplifier is perfectly matched with the output impedance of the sensor, thus eliminating distortion caused by signal reflection. The operational amplifier linearly amplifies the matched analog voltage signal, with the amplification factor dynamically set by a digital potentiometer. The output terminal of the operational amplifier is connected to a resistor-capacitor low-pass filter network, which consists of a series resistor and a parallel capacitor, to filter out high-frequency noise generated by the flow of the perfusion fluid and external electromagnetic interference.

[0084] Specifically, the analog voltage signal output from the through-type pressure sensor is first input to an operational amplifier. The operational amplifier achieves impedance matching through an adjustable resistor network at its input, ensuring a perfect match between the amplifier's input impedance and the sensor's output impedance. This eliminates distortion caused by signal reflection, guaranteeing signal integrity and accuracy. The matched analog voltage signal is then linearly amplified by the operational amplifier. The amplification factor can be dynamically set via a digital potentiometer to adapt to different pressure ranges and signal requirements under surgical conditions, ensuring the pressure signal is within the ideal voltage range before analog-to-digital conversion. The output of the operational amplifier is connected to a resistor-capacitor low-pass filter network consisting of a series resistor and a parallel capacitor. This network effectively filters out high-frequency noise generated by the perfusion fluid flow and external electromagnetic interference, preventing noise from affecting subsequent analog-to-digital conversion and the control system. This design provides a high-precision, stable pressure signal in real time, providing a reliable data foundation for the automatic pressure relief module and surgical procedures, improving surgical safety, and reducing damage to the patient's urinary system caused by fluid backflow or abnormal pressure.

[0085] As a preferred embodiment, the solution of this application is implemented as follows: When a physician infuses saline solution into the renal pelvis through a sheath, the minute turbulence caused by the flow of the infusion fluid generates high-frequency noise in the analog voltage signal output by the through-type pressure sensor. Without processing, this noise may cause excessive fluctuations in pressure monitoring data, affecting the judgment of the automatic pressure relief module. By using an operational amplifier to perform impedance matching on the sensor signal, the input impedance is perfectly matched to the sensor's output impedance, eliminating errors caused by signal reflection. The operational amplifier linearly amplifies the matched signal, with the amplification factor dynamically adjusted by a digital potentiometer to ensure the signal is stable and effective within the input range of the analog-to-digital converter.

[0086] Understandably, the synergistic effect of the operational amplifier and low-pass filter network improves the accuracy and stability of the pressure signal within the flexible endoscope sheath. Impedance matching eliminates reflections and distortions in the sensor output signal, allowing the signal to be transmitted completely and without loss to the amplifier input. Linear amplification brings the weak pressure signal to a range suitable for analog-to-digital converter processing, ensuring the reliability of data acquisition. The low-pass filter network filters out high-frequency interference from perfusion fluid flow and the operating room environment, thereby reducing spurious pressure fluctuations.

[0087] This application further proposes that when the first processing unit samples and quantizes the analog voltage signal based on the analog-to-digital conversion circuit to generate discrete pressure data values ​​in digital form, it includes:

[0088] The timing control unit of the analog-to-digital converter (ADC) generates a precise sampling clock signal, and the sampling frequency is determined by a preset sampling rate parameter. The sample-and-hold module of the ADC captures the instantaneous value of the conditioned analog voltage signal under the trigger of the clock signal and maintains the instantaneous value stable until quantization is complete. The quantizer of the ADC adopts a successive approximation architecture, compares the analog voltage signal with the internal reference voltage, and generates the corresponding discrete pressure data value in digital form through a binary search algorithm.

[0089] Specifically, the analog-to-digital conversion circuit ensures high accuracy and real-time performance in processing the pressure signal inside the soft lens sheath. The timing control unit generates a precise sampling clock signal according to a preset sampling rate parameter, ensuring that each sampling interval is fixed and stable, thereby capturing the continuous dynamic characteristics of pressure changes. The sample-and-hold module locks the instantaneous value of the conditioned analog voltage signal at each sampling moment and keeps this value unchanged until quantization is complete, to avoid errors introduced by instantaneous fluctuations. The quantizer adopts a successive approximation architecture, which accurately generates the corresponding discrete pressure data value in digital form by progressively comparing the sampled analog voltage with the internal reference voltage and combining it with a binary search algorithm.

[0090] As a preferred embodiment, the solution of this application is implemented as follows: During ureteroscopic surgery, the analog-to-digital conversion circuit plays a crucial role in processing the pressure signal within the ureteroscopic sheath. At the start of the operation, the timing control unit generates a sampling clock signal every millisecond according to a preset sampling rate, ensuring that pressure fluctuations caused by the irrigation fluid can be captured in real time; the sample-and-hold module locks the conditioned analog voltage signal at each sampling moment and keeps it stable until quantization is complete, avoiding short-term fluctuations from affecting data accuracy; subsequently, the successive approximation quantizer compares the sampled analog voltage with the internal reference voltage in multiple rounds, and accurately generates discrete pressure data in digital form through a binary search algorithm. For example, when the pressure within the ureteroscopic sheath suddenly increases from 120 mmHg to 180 mmHg, the analog-to-digital conversion circuit can capture this change within milliseconds and generate the corresponding discrete digital signal, providing a reliable basis for the control device to promptly determine whether the pressure exceeds the threshold and trigger automatic pressure relief, thereby ensuring the safety of the surgical operation and the dynamic stability of the bladder and renal pelvis pressure.

[0091] Understandably, the timing control unit generates a precise sampling clock, ensuring that every instantaneous pressure change is captured; the sample-and-hold module locks the instantaneous analog voltage signal and keeps it stable, so that short-term interference or fluctuations will not affect the quantization results; the successive approximation quantizer accurately converts the analog signal into discrete digital values ​​through multiple rounds of binary comparison, thereby providing stable and reliable pressure data.

[0092] This application further proposes that the second processing unit generates the final pressure data value by accumulating the discrete pressure data values ​​of continuous sampling points and calculating their average value, including:

[0093] Set a sliding window, the size of which is determined by a preset sampling point number parameter; calculate the arithmetic sum of all discrete pressure data values ​​in real time, divide the arithmetic sum by the window size to obtain the sliding average value, which is used as the final pressure data value.

[0094] Specifically, during the generation of the final pressure data value, a sliding window is set on the sampled data sequence. The size of this window is determined by a preset parameter for the number of sampling points to ensure the continuity and stability of data processing. Whenever a new sampling point is generated, the discrete pressure data value is added to the sliding window, while the oldest data point is removed, ensuring that the window always contains the latest continuous data. The control module accumulates all discrete pressure data values ​​within the window to obtain an arithmetic sum, and then divides this sum by the window size to calculate the moving average, which is used as the final pressure data value. This method effectively suppresses the influence of instantaneous fluctuations or noise from single-point measurements on the pressure reading, ensuring stable and reliable pressure data, facilitating subsequent pressure threshold judgment and automatic pressure relief operations by the control device. The moving average processing also improves the pressure monitoring system's immunity to short-term interference, maintaining continuous and controllable pressure within the sheath during flexible endoscope operation.

[0095] As a preferred embodiment, the solution of this application is implemented as follows: During cystoscopy or ureteroscopy, a pressure sensor is used to collect pressure signals within the sheath in real time, generating hundreds of discrete pressure data points per second. The control module sets a sliding window for these data, with a window size of 20 consecutive sampling points. Whenever a new sampling point enters the window, the 20 data points within the window are summed and then divided by the window size to obtain the sliding average value as the final pressure data value. When the infusion fluid is rapidly injected into the sheath, causing a momentary increase in pressure, a single sampling point may show large pressure fluctuations. However, after processing with the sliding average, the final pressure data value smoothly reflects the overall pressure trend within the sheath, avoiding false triggering of pressure relief operations caused by short-term pulses or minor interferences.

[0096] Understandably, by generating the final pressure data value through moving average processing, instantaneous pressure fluctuations caused by irrigation fluid flow, surgical vibration, or external electromagnetic interference are suppressed, making pressure monitoring more stable and reliable. By dynamically calculating the average value of continuous sampling points, the overall pressure trend of the flexible endoscope sheath can be reflected in real time, avoiding misjudgment or accidental triggering of the pressure relief device due to a single abnormal data point.

[0097] This application further proposes that when the output unit periodically compares the final pressure data value with the pressure threshold, it includes:

[0098] The final pressure data value is compared with the preset pressure threshold; the comparison period is precisely set through the clock module and repeated within a fixed time interval; the comparison period is dynamically adjusted according to the pressure change rate, automatically shortening or extending the comparison interval.

[0099] Specifically, during the periodic comparison of the final pressure data value with the preset pressure threshold, the final pressure data value processed by the moving average is compared with the set safe pressure threshold to determine whether the current pressure inside the flexible endoscope sheath exceeds the safe range. The comparison operation is precisely controlled by a built-in clock module, and the time interval of each comparison cycle is determined by preset parameters to ensure the continuity and real-time performance of pressure monitoring. The comparison cycle is dynamically adjusted according to the pressure change rate: when a rapid increase or decrease in pressure is detected, the comparison interval is automatically shortened to increase the monitoring frequency and improve the response speed to sudden pressure changes; when the pressure change is stable and remains near the threshold for a long time, the comparison interval can be appropriately extended to reduce the processor load and energy consumption. Through this periodic and dynamic adjustment mechanism, the pressure inside the flexible endoscope sheath can be monitored in real time, triggering pressure relief or alarm operations in a timely manner.

[0100] As a preferred embodiment, the solution of this application is implemented as follows: The final pressure data value after moving average processing is acquired in real time and compared with a preset pressure threshold. The preset pressure threshold is 200 mmHg. When the final pressure data value reaches 180 mmHg, a periodic comparison is performed at a fixed time interval of once per second using a built-in clock module to ensure continuous monitoring of intracavitary pressure changes. If a rapid pressure increase is detected in several consecutive comparisons, such as rising from 180 mmHg to 210 mmHg within 5 seconds, the comparison period is dynamically shortened to once every 0.5 seconds based on the pressure change rate, in order to quickly capture pressure peaks and trigger a pressure relief device or alarm. Conversely, when the pressure data value remains stable between 150–170 mmHg for a long period, with gentle pressure changes, the comparison interval is automatically extended to once every 2 seconds to reduce processor load and optimize resource utilization. Through this real-time comparison mechanism combining fixed period and dynamic adjustment, the pressure inside the flexible endoscope sheath can be precisely controlled during surgery.

[0101] Understandably, by periodically comparing the final pressure data value with a preset pressure threshold, real-time monitoring and dynamic control of the pressure within the flexible endoscope sheath are achieved. During the comparison process, a clock module precisely controls the comparison period, ensuring that each test is completed within a fixed time interval. Simultaneously, the comparison frequency is automatically adjusted based on the pressure change rate; the comparison interval is shortened when pressure changes rapidly to improve response speed, and lengthened when pressure is stable to reduce processor load. This allows for timely detection of pressure anomalies, triggering pressure relief devices or alarms, preventing damage to the renal pelvis or bladder caused by excessive pressure within the flexible endoscope sheath.

[0102] This application further proposes that when the output unit generates an on or off control signal based on the result of a periodic comparison, it includes:

[0103] When the pressure data value is greater than the pressure threshold, a control signal is generated to drive the pressure relief device to open. The power drive circuit receives the opening control signal, activates the electromagnetic actuator in the pressure relief device, and opens the pressure relief channel, allowing the liquid in the flexible endoscope sheath to be discharged through the pressure relief channel. When the filtered pressure data is less than the pressure threshold, a control signal is generated to drive the pressure relief device to close. The power drive circuit receives the closing control signal, resets the electromagnetic actuator in the pressure relief device to close the pressure relief channel, and blocks the liquid discharge path from the flexible endoscope sheath.

[0104] Specifically, when the final pressure data value after moving average processing exceeds a preset pressure threshold through periodic comparison, the control system immediately generates an opening control signal. This signal is transmitted to the electromagnetic actuator in the pressure relief device via a power drive circuit. The electromagnetic actuator is activated and pushes the pressure relief valve open, forming a fluid discharge channel. This effectively releases excess perfusion fluid and pressure within the flexible endoscope sheath, thereby rapidly reducing intraluminal static pressure and preventing damage to the renal pelvis or bladder due to excessive pressure. Continuous monitoring of pressure data changes means that when the pressure data value falls below the threshold, the control system generates a closing control signal. This signal, via the power drive circuit, resets the electromagnetic actuator, closing the pressure relief channel, preventing further fluid discharge, and maintaining the pressure within the flexible endoscope sheath within a safe range.

[0105] As a preferred embodiment, the solution of this application is implemented as follows: During cystoscopy or ureteroscopy, when the flexible endoscope irrigation fluid is injected into the cavity and maintains a certain flow rate, a pathway-type pressure sensor monitors the intracavitary pressure in real time. If the intracavitary pressure rises due to excessive irrigation fluid flow or sudden obstruction during the operation, the pressure data value may exceed a preset pressure threshold. An opening control signal is immediately generated and transmitted to the electromagnetic actuator in the pressure relief device through a power drive circuit. The solenoid valve is activated and opens the pressure relief channel, allowing some irrigation fluid to be discharged through the pressure relief channel, rapidly reducing the intracavitary pressure and avoiding tissue damage. When the intracavitary pressure falls back to a safe range, and the filtered pressure data is lower than the threshold, a closing control signal is generated, causing the electromagnetic actuator to reset, closing the pressure relief channel, blocking fluid discharge, ensuring that the intracavitary pressure is maintained at a safe level, while continuing to maintain the irrigation fluid supply, thus achieving dynamic balance and safe control of pressure during the operation.

[0106] Understandably, through precise pressure monitoring and automatic control, dynamic adjustment and safety assurance of the fluid pressure inside the flexible endoscope sheath are achieved. When the pressure data value exceeds the preset threshold, an opening control signal is automatically generated, driving the pressure relief device to quickly discharge excess fluid, preventing damage to the urethra or renal pelvis tissue caused by excessive intracavitary pressure; and when the pressure drops back to a safe range, a closing control signal is automatically generated, closing the pressure relief channel, avoiding excessive fluid loss and maintaining stable surgical perfusion.

[0107] In another preferred embodiment based on the above embodiments, see [reference] Figure 4 As shown, this embodiment provides a pressure control method for a flexible ureteroscope sheath device, used in applying the aforementioned flexible ureteroscope sheath device, comprising:

[0108] S100: The initial digital reference value is set based on the initial output signal of the through-type pressure sensor under ambient atmospheric pressure.

[0109] S200: Real-time monitoring of the static pressure difference between the inner lumen of the flexible endoscope sheath and the external environment via a via-type pressure sensor, outputting an analog voltage signal proportional to the static pressure difference;

[0110] S300: Based on an operational amplifier, impedance matching is performed on the analog voltage signal, and low-pass filtering is used to suppress high-frequency electromagnetic interference and noise caused by the flow of the perfusion fluid; the analog-to-digital conversion circuit samples and quantizes the analog voltage signal to generate discrete pressure data values ​​in digital form;

[0111] S400: Performs moving average filtering on discrete pressure data values ​​in digital form, and generates the final pressure data value by accumulating the discrete pressure data values ​​of continuous sampling points and calculating their average value.

[0112] S500: Periodically compares the final pressure data value with the pressure threshold; and generates an on or off control signal based on the result of the periodic comparison.

[0113] S600: When the duration of the pressure data value exceeding the pressure threshold is greater than the time threshold, an early warning message is issued.

[0114] Specifically, the pressure control method for the ureteroscopic sheath device involves acquiring an initial output signal at ambient atmospheric pressure using a access-type pressure sensor before the procedure begins. This signal is then set as the initial digital reference value to ensure a reliable reference standard for subsequent pressure monitoring. During the procedure, the access-type pressure sensor monitors the static pressure difference between the lumen of the ureteroscopic sheath and the external environment in real time, converting pressure changes into an analog voltage signal proportional to the static pressure difference. An operational amplifier performs impedance matching on the analog voltage signal to ensure no distortion occurs during signal transmission due to impedance mismatch. Simultaneously, a low-pass filter network suppresses noise caused by high-frequency electromagnetic interference and irrigation fluid flow, ensuring signal accuracy. An analog-to-digital converter samples and quantizes the conditioned analog voltage signal, generating discrete pressure data values ​​in digital form. To reduce the impact of instantaneous fluctuations on the data, a moving average filtering process is performed on these discrete pressure data values. This involves accumulating data from consecutive sampling points and calculating the average value, resulting in a smoother and more reliable final pressure data value. This final pressure data value is periodically compared with a preset pressure threshold. By precisely controlling the comparison period, it is possible to determine in real time whether the pressure exceeds the safe range. If the pressure value exceeds the threshold, an activation control signal will be automatically generated to drive the pressure relief device to drain and release the liquid. When the pressure returns to a safe range, a deactivation control signal will be generated to close the pressure relief device, blocking the liquid discharge path and maintaining stable pressure within the chamber. If the pressure remains above the threshold for an extended period exceeding the set time threshold, a warning message will be issued, prompting the operator to intervene promptly via an audible and visual alarm or a digital display.

[0115] The pressure threshold is used to determine whether the fluid pressure inside the flexible endoscopic sheath exceeds the safe range, and is generally determined based on clinical surgical experience and physiological tolerance limits. For adult urological surgeries, the safe pressure inside the flexible endoscopic sheath is usually controlled at around 200 mmH2O, which is approximately 0.02 MPa. When the pressure value exceeds this threshold, it indicates that the intraluminal pressure may cause stress to the urethra, ureter, or renal pelvis, requiring immediate triggering of pressure relief control. The threshold setting must ensure sufficient irrigation fluid to maintain the surgical field while avoiding excessive pressure that could damage tissues. The threshold can be fine-tuned according to the patient's body size, surgical site, and type of irrigation fluid; for example, it can be set at 150–180 mmH2O for pediatric surgery, and slightly lowered to 180–190 mmH2O for high-risk adult patients to increase the safety margin. The time threshold is used to determine the duration for which the pressure exceeds the threshold, preventing accidental actions caused by brief, momentary pressure fluctuations. It is generally set within ten seconds, such as 5–10 seconds. This time frame is sufficient to filter out brief pressure spikes while ensuring timely pressure relief or warnings during sustained overpressure, preventing tissue damage from prolonged high pressure. The time threshold can also be adjusted based on the type of surgery and perfusion flow characteristics; for example, the time threshold can be appropriately shortened during high-flow perfusion to respond quickly to pressure increases.

[0116] Understandably, a pressure sensor with a via path collects the static pressure difference signal between the flexible endoscope sheath and the external environment. This signal is then processed by operational amplifier impedance matching and low-pass filtering to eliminate signal interference and noise, ensuring the stability and accuracy of the pressure data. An analog-to-digital converter samples and quantizes the processed analog signal to generate discrete digital pressure data. This data is then processed by a moving average filter to obtain the final pressure value. By periodically comparing this value with a preset pressure threshold, an automatic opening or closing control signal is generated to drive the pressure relief device to regulate the pressure inside the flexible endoscope sheath. When the pressure remains above the safety threshold for an extended period, an audible and visual warning is issued to alert the physician to take intervention measures, thereby preventing tissue damage or intraoperative complications caused by excessive pressure in the renal pelvis and bladder.

[0117] In summary, by using a circumferentially arranged pressure sensor in the central channel of the sheath, real-time and continuous monitoring of intrarenal pressure is achieved. Combined with an automatic pressure relief module, the pressure relief device is automatically activated when the pressure exceeds a set threshold, avoiding the risk of excessive intrarenal pressure due to delays caused by manual judgment. Operational amplifier impedance matching and low-pass filtering design suppress high-frequency noise and external electromagnetic interference caused by perfusion fluid flow. A moving average filtering algorithm smooths discrete sampling points, ensuring stable and reliable pressure data and improving measurement accuracy. The analog-to-digital conversion circuit quantizes the analog signal into a digital signal and, combined with dynamic sampling, a sliding window, and periodic comparison mechanisms, achieves digital and intelligent processing of pressure changes. When the pressure data value exceeds the threshold and continues to exceed the timeout, a multi-channel early warning system is automatically triggered, including audible and visual alarms and data interface reminders, preventing doctors from missing the intervention opportunity.

[0118] Those skilled in the art will understand that embodiments of this application can be provided as methods, systems, or computer program goods. Therefore, this application can take the form of a completely hardware embodiment, a completely software embodiment, or an embodiment combining software and hardware aspects. Furthermore, this application can take the form of a computer program goods embodied on one or more computer-usable storage media (including, but not limited to, disk storage, CD-ROM, optical storage, etc.) containing computer-usable program code.

[0119] This application is described with reference to flowchart illustrations and / or block diagrams of methods, apparatus (systems), and computer program goods according to embodiments of this application. It will be understood that each block of the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, special-purpose computer, embedded processor, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, generate instructions for implementing the flowchart... Figure 1 One or more processes and / or boxes Figure 1 A device that provides the functions specified in one or more boxes.

[0120] These computer program instructions may also be stored in a computer-readable storage medium that can direct a computer or other programmable data processing device to function in a particular manner, such that the instructions stored in the computer-readable storage medium produce an article of manufacture including instruction means, which are implemented in a process Figure 1 One or more processes and / or boxes Figure 1 The function specified in one or more boxes.

[0121] These computer program instructions may also be loaded onto a computer or other programmable data processing equipment to cause a series of operational steps to be performed on the computer or other programmable equipment to produce a computer-implemented process, thereby providing instructions that execute on the computer or other programmable equipment for implementing the process. Figure 1 One or more processes and / or boxes Figure 1 The steps of the function specified in one or more boxes.

[0122] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and not to limit it. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that modifications or equivalent substitutions can still be made to the specific implementation of the present invention. Any modifications or equivalent substitutions that do not depart from the spirit and scope of the present invention should be covered within the protection scope of the claims of the present invention.

Claims

1. A flexible ureteroscope sheath device, characterized in that, include: Multi-channel connectors, sheaths, pressure relief devices, control devices, flexible endoscopes and infusion connectors, and negative pressure suction connectors; The multi-channel connector tube seat is connected to a sheath tube at one end and three connectors at the other end. The first connector is connected to a pressure relief device and a control device, the second connector is a flexible endoscope and infusion connector, and the third connector is a negative pressure suction connector. The sheath includes a through-type pressure sensor and a central channel; the through-type pressure sensor is axially and evenly arranged around the central channel; The control device includes adjustment buttons, a digital display, indicator lights, and a buzzer; the control device is electrically connected to the pressure relief device and the through-type pressure sensor. The control device also includes an automatic pressure relief module, which collects the analog voltage signal of the through-type pressure sensor and converts the analog voltage signal into a final pressure data value. When the final pressure data value is detected to reach a pressure threshold, the automatic pressure relief module electrically controls the pressure relief device to release pressure. The automatic pressure relief module also includes a preset unit, a data acquisition unit, a first processing unit, a second processing unit, an output unit, and an early warning unit; The preset unit is used to set the initial digital reference value based on the initial output signal of the through-type pressure sensor under ambient atmospheric pressure. The acquisition unit is used to monitor the static pressure difference between the inner lumen of the flexible endoscope sheath and the external environment in real time through the through-type pressure sensor, and output an analog voltage signal proportional to the static pressure difference. The first processing unit is used to perform impedance matching on the analog voltage signal based on the operational amplifier, and to use low-pass filtering to suppress high-frequency electromagnetic interference and noise caused by the flow of perfusion fluid; The analog voltage signal is sampled and quantized using an analog-to-digital converter circuit to generate discrete pressure data values ​​in digital form. The second processing unit is used to perform moving average filtering on the discrete pressure data values ​​in digital form, and to generate the final pressure data value by accumulating the discrete pressure data values ​​of continuous sampling points and calculating their average value. The output unit is used to periodically compare the final pressure data value with the pressure threshold; and generate an on or off control signal based on the result of the periodic comparison. The early warning unit is used to issue an early warning message when the duration of the final pressure data value being greater than the pressure threshold is greater than the time threshold. When the output unit periodically compares the final pressure data value with the pressure threshold, it includes: The final pressure data value is compared with the preset pressure threshold. The comparison period is precisely set by the clock module and repeated within a fixed time interval. The comparison period is dynamically adjusted according to the pressure change rate. When a rapid increase or decrease in pressure is detected, the comparison interval is automatically shortened. When the pressure change is stable and remains near the threshold for a long time, the comparison interval is appropriately extended.

2. The ureteroscope sheath device according to claim 1, characterized in that, When the preset unit sets the initial digital reference value based on the initial output signal of the via-type pressure sensor under ambient atmospheric pressure, it includes: The preset unit detects the connectivity between the flexible endoscope sheath and the external environment, confirming that there is no liquid residue in the flexible endoscope sheath and that the pressure is completely balanced with the ambient atmospheric pressure. When the pressure fluctuation amplitude is lower than the fluctuation threshold and remains stable for a certain period of time, the initial analog voltage signal output by the through-type pressure sensor is periodically sampled. The clock module precisely controls the sampling interval for each sampling, collects a preset number of sample points and stores them in a temporary buffer. An arithmetic mean is performed on all sample points in the temporary buffer to eliminate random noise interference and generate the initial digital reference value.

3. The ureteroscope sheath device according to claim 2, characterized in that, The acquisition unit monitors the static pressure difference between the inner lumen of the flexible endoscope sheath and the external environment in real time through the via-type pressure sensor, and outputs an analog voltage signal proportional to the static pressure difference, including: The via-type pressure sensor is integrated into the fluid passage of the multi-channel connector tube seat, with its sensing diaphragm directly exposed to the perfusion fluid flow within the flexible endoscope sheath. When the pressure within the flexible endoscope sheath changes, the sensing diaphragm of the via-type pressure sensor undergoes physical deformation, driving a change in resistance in its internal piezoresistive sensing element. The via-type pressure sensor converts the resistance change into a differential analog voltage signal output. The signal output terminal of the via-type pressure sensor transmits the analog voltage signal through a shielded wire.

4. The ureteroscope sheath device according to claim 3, characterized in that, When the first processing unit performs impedance matching on the analog voltage signal based on an operational amplifier and uses low-pass filtering to suppress high-frequency electromagnetic interference and noise caused by the flow of perfusion fluid, it includes: The operational amplifier receives the analog voltage signal output from the channel-type pressure sensor. Impedance matching is achieved by adjusting the adjustable resistor network at its input terminal, ensuring that the input impedance of the operational amplifier is perfectly matched with the output impedance of the sensor, thus eliminating distortion caused by signal reflection. The operational amplifier linearly amplifies the matched analog voltage signal, with the amplification factor dynamically set by a digital potentiometer. The output terminal of the operational amplifier is connected to a resistor-capacitor low-pass filter network, which consists of a series resistor and a parallel capacitor, to filter out high-frequency noise generated by the flow of the perfusion fluid and external electromagnetic interference.

5. A flexible ureteroscope sheath device according to claim 4, characterized in that, When the first processing unit samples and quantizes the analog voltage signal based on the analog-to-digital conversion circuit to generate discrete pressure data values ​​in digital form, it includes: The timing control unit of the analog-to-digital converter (ADC) generates a precise sampling clock signal, and the sampling frequency is determined by a preset sampling rate parameter. The sample-and-hold module of the ADC captures the instantaneous value of the conditioned analog voltage signal under the trigger of the clock signal and maintains the instantaneous value stable until quantization is completed. The quantizer of the ADC adopts a successive approximation architecture, compares the analog voltage signal with the internal reference voltage, and generates the corresponding discrete pressure data value in digital form through a binary search algorithm.

6. A flexible ureteroscope sheath device according to claim 5, characterized in that, When the second processing unit generates the final pressure data value by accumulating the discrete pressure data values ​​of continuous sampling points and calculating their average value, it includes: The second processing unit sets a sliding window, the size of which is determined by a preset sampling point number parameter; it calculates the arithmetic sum of all the discrete pressure data values ​​in real time, and divides the arithmetic sum by the window size to obtain the sliding average value, which is used as the final pressure data value.

7. A flexible ureteroscope sheath device according to claim 6, characterized in that, When the output unit generates an on or off control signal based on the result of the periodic comparison, it includes: When the final pressure data value is greater than the pressure threshold, a control signal for driving the pressure relief device to open is generated. The power drive circuit receives the opening control signal, activates the electromagnetic actuator in the pressure relief device, and opens the pressure relief channel, allowing the liquid inside the flexible endoscope sheath to be discharged through the pressure relief channel. When the final pressure data value is less than the pressure threshold, a control signal for driving the pressure relief device to close is generated. The power drive circuit receives the closing control signal, resets the electromagnetic actuator in the pressure relief device to close the pressure relief channel, and blocks the liquid discharge path inside the flexible endoscope sheath.

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