Disposable bladder renal pelvis ureter flexible mirror system with intelligent temperature and pressure control function

Abstract

This invention relates to the field of ureteroscopic surgery technology, providing a disposable flexible cystoscopic, pyelonephric, and ureteroscopic system with intelligent temperature and pressure control functions. The system includes a disposable flexible endoscope body and an intelligent temperature and pressure control unit. The disposable flexible endoscope body includes a mid-section flexible insertion tube, a distal sensing lens tip, and a proximal operating handle. The distal sensing lens tip integrates an in-situ temperature and pressure measurement sensor, a miniature imaging module, an illumination fiber optic bundle, an instrument operating channel outlet, an irrigation channel outlet, and a suction channel outlet. Precise real-time monitoring is achieved through the in-situ temperature and pressure sensor at the tip, combined with dual-channel closed-loop control, keeping renal pelvic pressure fluctuations and temperature errors within a safe range, thus reducing the risk of infection and thermal damage at the source. The integrated structure eliminates the need for a pressure measuring sheath, resulting in less trauma and lower cost. Furthermore, the fully automated control significantly shortens the learning curve, greatly improving safety and practicality.

Description

Technical Field

[0001] This invention relates to the field of ureteroscopic surgery technology, specifically a disposable flexible cystoscopic, pyelonephroscope system with intelligent temperature and pressure control functions. Background Technology

[0002] The disposable flexible ureteroscope is a core instrument in urology for the treatment of kidney stones, ureteral stones, and upper urinary tract tumors. It is widely used in clinical practice, and the control of intrarenal pelvic pressure and local temperature during the operation directly determines the safety of the surgery.

[0003] Current clinical practice routinely employs a disposable flexible endoscope in conjunction with a split-type pressure-measuring sheath, an independent infusion pump, and a negative pressure suction device to complete the surgery through indirect external pressure measurement and manual adjustment.

[0004] Existing technologies lack in-situ temperature and pressure measurement, cannot link perfusion and suction in a closed loop, and lack active temperature control methods, resulting in large pressure and temperature monitoring errors, high risk of runaway, and frequent complications. At the same time, separate consumables increase trauma and cost, and the learning curve for operation is long, making it difficult to meet the needs of clinical safety and popularization. Summary of the Invention

[0005] To address the shortcomings of existing technologies, this invention provides a disposable flexible cystoscope / ureteroscope system with intelligent temperature and pressure control. This system solves the problems of existing disposable flexible ureteroscopes lacking in-situ temperature and pressure measurement capabilities, relying solely on indirect external pressure measurement which results in large errors and significant lag, and the inability to achieve closed-loop linkage between perfusion and suction, leading to drastic fluctuations in intrarenal pelvic pressure. Furthermore, the lack of active temperature control means that laser lithotripsy can easily cause tissue thermal burns. Additionally, the need for a separate pressure measurement sheath results in significant trauma, high cost, and complete reliance on physician experience, leading to a high risk of complications and a long learning curve.

[0006] To achieve the above objectives, the present invention provides the following technical solution: a disposable flexible cystoscope / nephroscope / ureteroscope system with intelligent temperature and pressure control function, comprising a disposable flexible endoscope body and an intelligent temperature and pressure control host; The disposable flexible lens body includes a mid-section flexible insertion tube, a distal sensing lens head end, and a proximal operating handle. The remote sensing lens head integrates an in-situ temperature and pressure measurement sensor, a miniature imaging module, an illumination fiber bundle, an instrument operation channel outlet, an infusion channel outlet, and a suction channel outlet; The flexible insertion tube in the middle section is equipped with independently sealed instrument operation channels, infusion channels, suction channels, sensor signal channels, bending control channels, and imaging illumination channels. The proximal operating handle is equipped with a bending control lever, an instrument operating inlet, an infusion quick-connect interface, a suction quick-connect interface, an electrical signal quick-connect interface, and a cold light source interface; The intelligent temperature and pressure control host includes a main control unit, an intelligent injection module, an intelligent suction module, a constant temperature control module, a signal acquisition and processing module, a human-machine interaction early warning module, and a closed-loop control algorithm unit.

[0007] Preferably, the tip of the remote sensing lens is a cylindrical medical polymer structure with an outer diameter of Fr7-Fr10, a length of ≤5mm, and can be bent in both directions at ≥270°. The in-situ temperature and pressure integrated sensor is a MEMS chip with a package size of ≤0.6mm×0.6mm×0.4mm, and the sensing surface is directly exposed to the surgical area environment.

[0008] Preferably, the in-situ integrated temperature and pressure sensor has a pressure range of -20 to +200 mmHg and a temperature range of 10 to 60°C. The sensor signal is transmitted through the shielded cable in the sensor signal channel to the pre-processing signal board in the near-end operating handle, and then input to the host signal acquisition and processing module.

[0009] Preferably, the length of the flexible insertion tube in the middle section is 700-900mm, and from the inside out, it consists of a PTFE inner liner tube, a stainless steel wire braided reinforcement layer, and a TPU hydrophilic coating tube; the inner diameter of the injection channel and the suction channel are both 0.8-1.0mm, and they are completely isolated, and are respectively connected to the injection channel outlet and the suction channel outlet symmetrically arranged on the end of the remote sensing lens.

[0010] Preferably, a pre-processing signal board is provided inside the proximal operating handle for amplifying, filtering, and noise reduction of the weak signal from the in-situ integrated temperature and pressure sensor; both the injection quick-connect interface and the suction quick-connect interface adopt a Luer lock quick-connect structure, and the electrical signal quick-connect interface adopts a foolproof and waterproof structure.

[0011] Preferably, the intelligent perfusion module is a high-precision peristaltic pump with a flow rate range of 0-100 ml / min and an adjustment accuracy of ≤±0.5 ml / min; the intelligent suction module is a medical negative pressure suction pump with a negative pressure adjustment range of 0 to -200 mmHg and an adjustment accuracy of ≤±2 mmHg; and the constant temperature control module is a semiconductor heating and cooling dual control structure with a temperature control range of 30-40℃ and a control accuracy of ≤±0.3℃.

[0012] Preferably, the closed-loop control algorithm unit includes a pressure closed-loop PID control algorithm, a temperature closed-loop control algorithm, a graded safety early warning algorithm, and an adaptive anti-interference algorithm; the host signal sampling rate is ≥200Hz, the intrarenal pelvis pressure control fluctuation amplitude is ≤±5mmHg, and the temperature control of the surgical area is completed within 10 seconds after the temperature exceeds the threshold.

[0013] Preferably, the hierarchical security early warning algorithm is configured as follows: The first-level warning threshold for pressure is 40 mmHg, and the second-level warning threshold is 60 mmHg. The temperature warning threshold is 40℃ for Level 1 and 42℃ for Level 2. When the secondary threshold is reached, the infusion will automatically stop, the suction will be fully opened, an audible and visual warning will be activated, and a prompt to pause the laser operation will be displayed.

[0014] Preferably, the disposable flexible endoscope body is a disposable sterile product sterilized with ethylene oxide. The one-piece structure does not require an external pressure-measuring insertion sheath and is disposed of as medical waste after use. The host is equipped with HDMI, USB, RS485 communication interfaces and a cold light source output interface, which can be connected to external display devices and hospital data systems to realize data storage and traceability.

[0015] Preferably, the intelligent temperature and pressure control workflow is implemented by following these steps: Step 1: Quickly connect the disposable flexible endoscope body to the intelligent temperature and pressure control host to complete the zero-point calibration of the in-situ integrated temperature and pressure measurement sensor; Step 2: Initiate self-checks of the infusion and suction pathways, and set target pressure, target temperature, and safety warning thresholds; Step 3: Insert the disposable flexible endoscope into the renal pelvis and calyces, and use an in-situ integrated temperature and pressure sensor to collect pressure and temperature data in real time; Step 4: The main unit synchronously adjusts the infusion flow rate, suction negative pressure, and infusion fluid temperature based on real-time data to maintain stable pressure and temperature; Step 5: When the pressure or temperature exceeds the threshold, activate the graded early warning system and execute emergency control measures; Step Six: After the surgery, disconnect the connection, discard the disposable flexible endoscope, and save all data from the entire procedure on the main unit.

[0016] This invention provides a disposable flexible cystoscope, pyeloscope, and ureteroscope system with intelligent temperature and pressure control functions. It has the following beneficial effects: 1. This invention integrates a sensor in situ at the head end of a remote sensing lens to achieve direct measurement of surgical area pressure and temperature without conduction, conversion, or lag. The monitoring accuracy and real-time performance far exceed those of traditional external pressure measurement methods.

[0017] 2. This invention employs a closed-loop control system linking independent perfusion and suction channels, keeping intrarenal pelvic pressure fluctuations within ±5 mmHg. This provides 10 times greater stability than manual adjustment, effectively preventing sepsis and kidney damage caused by high pressure from the source.

[0018] 3. By linking in-situ temperature measurement with constant temperature infusion and flow regulation, rapid cooling can be achieved within 10 seconds, resulting in high efficiency in preventing thermal damage. At the same time, the integrated sterile structure eliminates the need for an external pressure sheath, resulting in less trauma, lower consumable costs, and simple and easy operation. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the present invention. Figure 1 ; Figure 2 This is a schematic diagram of the present invention. Figure 2 .

[0020] Among them, 1. Insertion part; 1-1. Head end; 1-2. Bending part; 2. Operating part; 2-1. Handle; 2-2. Suction knob; 2-3. Suction channel; 2-4. Infusion channel outlet; 2-5. Instrument channel; 3. Handle connection cable. Detailed Implementation

[0021] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0022] Example: As one aspect of the present invention, please refer to the appendix. Figure 1 and attached Figure 2 A disposable flexible cystoscope, nephroptoscope, and ureteroscope system with intelligent temperature and pressure control functions, including a disposable flexible endoscope body 1 and an intelligent temperature and pressure control host; The disposable flexible endoscope body 1 includes a mid-section flexible insertion tube 1-1, a distal sensing lens tip 1-2, and a proximal operating handle 2. The disposable flexible endoscope body 1 is a disposable sterile product sterilized with ethylene oxide. The integrated structure does not require an external pressure measuring insertion sheath. After use, it is disposed of as medical waste. The host is equipped with HDMI, USB, RS485 communication interfaces and a cold light source output interface, which can be connected to external display devices and hospital data systems to realize data storage and traceability. The distal sensing lens head 1-2 is a cylindrical medical polymer structure with an outer diameter of Fr7-Fr10 and a length ≤5mm. It can be bent in both directions at ≥270°. It integrates an in-situ temperature and pressure measurement integrated sensor 3, which is a MEMS chip with a package size ≤0.6mm×0.6mm×0.4mm. The sensing surface is directly exposed to the surgical area environment. The pressure range is -20~+200mmHg, and the temperature range is 10~60℃. The device includes a miniature imaging module 4, an illumination fiber bundle 5, an instrument operation channel outlet 6, an infusion channel outlet 7, and a suction channel outlet 8. The sensor signal is transmitted through the shielded cable in the sensor signal channel to the pre-processing signal board in the proximal operating handle 2, and then input to the host signal acquisition and processing module. The length of the flexible insertion tube 1-1 in the middle section is 700-900mm. From the inside out, it consists of a PTFE inner liner tube, a stainless steel wire braided reinforcement layer, and a TPU hydrophilic coating tube. Inside, there are independently sealed instrument operation channels, infusion channels, suction channels, sensor signal channels, bending control channels, and imaging illumination channels. The inner diameter of the infusion channel and the suction channel is 0.8-1.0mm. They are completely isolated and connected to the infusion channel outlet 7 and the suction channel outlet 8 symmetrically arranged on the tip of the remote sensing lens 1-2, respectively. The proximal operating handle 2 is equipped with a bending control lever 2-1, an instrument operation inlet 2-2, an infusion quick-connect interface 2-3, a suction quick-connect interface 2-4, an electrical signal quick-connect interface 2-5, and a cold light source interface 2-6. It contains a pre-processing signal board for amplifying, filtering, and noise reduction of the weak signal from the in-situ integrated temperature and pressure sensor 3. Both the infusion quick-connect interface 2-3 and the suction quick-connect interface 2-4 adopt a Luer lock quick-connect structure, while the electrical signal quick-connect interface 2-5 adopts a foolproof and waterproof structure. The intelligent temperature and pressure control unit includes a main control unit, an intelligent perfusion module, an intelligent suction module, a constant temperature control module, a signal acquisition and processing module, a human-machine interaction and early warning module, and a closed-loop control algorithm unit. The intelligent perfusion module is a high-precision peristaltic pump with a flow rate range of 0-100 ml / min and an adjustment accuracy of ≤±0.5 ml / min. The intelligent suction module is a medical negative pressure suction pump with a negative pressure adjustment range of 0~-200 mmHg and an adjustment accuracy of ≤±2 mmHg. The constant temperature control module has a semiconductor heating and cooling dual-control structure with a temperature control range of 30-40℃ and a control accuracy of ≤±0.3℃. The closed-loop control algorithm unit includes a pressure closed-loop PID control algorithm, a temperature closed-loop control algorithm, a graded safety early warning algorithm, and an adaptive anti-interference algorithm. The main unit signal sampling rate is ≥200Hz, the intrarenal pelvic pressure fluctuation is ≤±5 mmHg, and cooling regulation is completed within 10 seconds after the surgical area temperature exceeds the threshold. The graded safety early warning algorithm is set as follows: The first-level warning threshold for pressure is 40 mmHg, and the second-level warning threshold is 60 mmHg. The temperature warning threshold is 40℃ for Level 1 and 42℃ for Level 2. When the secondary threshold is reached, the infusion will automatically stop, the suction will be fully opened, an audible and visual warning will be activated, and a prompt to pause the laser operation will be displayed.

[0023] As another aspect of the present invention, the intelligent temperature and pressure control workflow is implemented according to the following steps: Step 1: Quickly connect the disposable flexible mirror body 1 to the intelligent temperature and pressure control host to complete the zero-point calibration of the in-situ integrated temperature and pressure measurement sensor 3; Step 2: Initiate self-checks of the infusion and suction pathways, and set target pressure, target temperature, and safety warning thresholds; Step 3: Insert the disposable flexible endoscope body 1 into the renal pelvis and calyces, and the in-situ integrated temperature and pressure sensor 3 collects pressure and temperature data in real time; Step 4: The main unit synchronously adjusts the infusion flow rate, suction negative pressure, and infusion fluid temperature based on real-time data to maintain stable pressure and temperature; Step 5: When the pressure or temperature exceeds the threshold, activate the graded early warning system and execute emergency control measures; Step Six: After the surgery, disconnect the connection, discard the disposable flexible endoscope body 1, and save the entire data on the main unit.

[0024] To better illustrate the embodiments of the present invention, specific examples are given below: Example 1 System: Disposable flexible endoscope body 1, intelligent temperature and pressure control host.

[0025] Flexible endoscope specifications: Fr8, with a flexible insertion tube 1-1 in the middle section, 750mm in length.

[0026] Remote sensing lens head 1-2: In-situ temperature and pressure measurement integrated sensor 3, miniature imaging module 4, illumination fiber bundle 5.

[0027] Proximal operating handle 2: Bending control lever 2-1, Injection quick-connect interface 2-3, Suction quick-connect interface 2-4, Electrical signal quick-connect interface 2-5.

[0028] The procedure was performed correctly, with stable pressure and temperature during the operation, and no postoperative complications.

[0029] Implementation 2 The disposable flexible endoscope body is of specification Fr7.5, and the flexible insertion tube in the middle section is 820mm in length.

[0030] A remote sensing lens head 1-2 is equipped with an in-situ integrated temperature and pressure sensor 3.

[0031] The near-end operating handle 2 uses a quick-connect structure to connect with the main unit.

[0032] Follow the temperature control procedure step by step, and reduce the temperature to a safe range within 9 seconds after it exceeds the threshold.

[0033] Example 3 Disposable flexible endoscope body 1, specification Fr9, with a flexible insertion tube 1-1 in the middle section, 900mm in length.

[0034] The remote sensing lens head has 1-2 dual-channel high-speed circulation.

[0035] Follow the pressure control procedure step by step, and initiate emergency pressure reduction within 1 second if the pressure rises suddenly.

[0036] Performance Comparison Table: The results show that the system of the present invention is significantly superior to the prior art in terms of temperature and pressure accuracy, control stability, response speed, safety and cost, and is suitable for various disposable flexible endoscopic surgeries in urology.

[0037] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art 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 appended claims and their equivalents.

Claims

1. A disposable flexible cystoscope / nephroscope / ureteroscope system with intelligent temperature and pressure control function, characterized in that, Includes a disposable flexible endoscope body (1) and an intelligent temperature and pressure control unit; The disposable flexible endoscope body (1) includes a mid-section flexible insertion tube (1-1), a distal sensing lens head end (1-2), and a proximal operating handle (2). The remote sensing lens head end (1-2) integrates an in-situ temperature and pressure measurement integrated sensor (3), a miniature imaging module (4), an illumination fiber bundle (5), an instrument operation channel outlet (6), an infusion channel outlet (7), and a suction channel outlet (8). The flexible insertion tube (1-1) in the middle section is provided with an independently sealed instrument operation channel, infusion channel, suction channel, sensor signal channel, bending control channel, and imaging illumination channel. The proximal operating handle (2) is equipped with a bending control lever (2-1), an instrument operating inlet (2-2), an infusion quick-connect interface (2-3), a suction quick-connect interface (2-4), an electrical signal quick-connect interface (2-5), and a cold light source interface (2-6). The intelligent temperature and pressure control host includes a main control unit, an intelligent injection module, an intelligent suction module, a constant temperature control module, a signal acquisition and processing module, a human-machine interaction early warning module, and a closed-loop control algorithm unit.

2. The disposable flexible cystoscope / nephroscope system with intelligent temperature and pressure control function according to claim 1, characterized in that, The distal sensing lens head (1-2) is a cylindrical medical polymer structure with an outer diameter of Fr7-Fr10 and a length of ≤5mm. It can be bent in both directions at ≥270°. The in-situ temperature and pressure integrated sensor (3) is a MEMS chip with a package size of ≤0.6mm×0.6mm×0.4mm, and the sensing surface is directly exposed to the surgical area environment.

3. The disposable flexible cystoscope / nephroscope system with intelligent temperature and pressure control function according to claim 1, characterized in that, The in-situ integrated temperature and pressure sensor (3) has a pressure range of -20 to +200 mmHg and a temperature range of 10 to 60℃. The sensor signal is transmitted through the shielded cable in the sensor signal channel to the pre-processing signal board in the near-end operating handle (2), and then input into the host signal acquisition and processing module.

4. The disposable flexible cystoscope / nephroscope system with intelligent temperature and pressure control function according to claim 1, characterized in that, The middle section of the flexible insertion tube (1-1) is 700-900mm long, and consists of a PTFE inner liner, a stainless steel wire braided reinforcement layer, and a TPU hydrophilic coating tube from the inside out. The inner diameter of the injection channel and the suction channel is 0.8-1.0mm, and they are completely isolated. They are connected to the injection channel outlet (7) and the suction channel outlet (8) symmetrically arranged on the end of the remote sensing lens (1-2).

5. The disposable flexible cystoscope / nephroscope system with intelligent temperature and pressure control function according to claim 1, characterized in that, The pre-processing signal board is installed inside the near-end operating handle (2) to amplify, filter and reduce the noise of the weak signal of the in-situ temperature and pressure integrated sensor (3); the injection quick-connect interface (2-3) and the suction quick-connect interface (2-4) both adopt Luer lock quick-connect structure, and the electrical signal quick-connect interface (2-5) adopts foolproof and waterproof structure.

6. The disposable flexible cystoscope / nephroscope system with intelligent temperature and pressure control function according to claim 1, characterized in that, The intelligent perfusion module is a high-precision peristaltic pump with a flow rate range of 0-100 ml / min and an adjustment accuracy of ≤±0.5 ml / min; the intelligent suction module is a medical negative pressure suction pump with a negative pressure adjustment range of 0 to -200 mmHg and an adjustment accuracy of ≤±2 mmHg; the constant temperature control module is a semiconductor heating and cooling dual control structure with a temperature control range of 30-40℃ and a control accuracy of ≤±0.3℃.

7. The disposable flexible cystoscope / nephroscope system with intelligent temperature and pressure control function according to claim 1, characterized in that, The closed-loop control algorithm unit includes a pressure closed-loop PID control algorithm, a temperature closed-loop control algorithm, a graded safety early warning algorithm, and an adaptive anti-interference algorithm; the host signal sampling rate is ≥200Hz, the intrarenal pelvis pressure control fluctuation amplitude is ≤±5mmHg, and the temperature control of the surgical area is completed within 10 seconds after the temperature exceeds the threshold.

8. The disposable flexible cystoscope / nephroscope system with intelligent temperature and pressure control function according to claim 1, characterized in that, The hierarchical security early warning algorithm is configured as follows: The first-level warning threshold for pressure is 40 mmHg, and the second-level warning threshold is 60 mmHg. The temperature warning threshold is 40℃ for Level 1 and 42℃ for Level 2. When the secondary threshold is reached, the infusion will automatically stop, the suction will be fully opened, an audible and visual warning will be activated, and a prompt to pause the laser operation will be displayed.

9. The disposable flexible cystoscope / nephroscope system with intelligent temperature and pressure control function according to claim 1, characterized in that, The disposable flexible endoscope body (1) is a disposable sterile product sterilized with ethylene oxide. The integrated structure does not require an external pressure measuring insertion sheath. After use, it is disposed of as medical waste. The host is equipped with HDMI, USB, RS485 communication interfaces and a cold light source output interface, which can be connected to external display devices and hospital data systems to realize data storage and traceability.

10. The disposable flexible cystoscope / nephroscope system with intelligent temperature and pressure control function according to claim 1, characterized in that, To implement the intelligent temperature and pressure control workflow, follow these steps: Step 1: Quickly connect the disposable flexible mirror body (1) to the intelligent temperature and pressure control host to complete the zero-point calibration of the in-situ integrated temperature and pressure sensor (3); Step 2: Initiate self-checks of the infusion and suction pathways, and set target pressure, target temperature, and safety warning thresholds; Step 3: Place the disposable flexible endoscope body (1) into the renal pelvis and calyces, and use the in-situ integrated temperature and pressure sensor (3) to collect pressure and temperature data in real time; Step 4: The main unit synchronously adjusts the infusion flow rate, suction negative pressure, and infusion fluid temperature based on real-time data to maintain stable pressure and temperature; Step 5: When the pressure or temperature exceeds the threshold, activate the graded early warning system and execute emergency control measures; Step 6: After the surgery, disconnect the connection, discard the disposable flexible endoscope body (1), and save the entire data in the host.

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