WO2024254845A1 - 一种灌注吸引系统的恒压及控温方法 - Google Patents

一种灌注吸引系统的恒压及控温方法 Download PDF

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Publication number
WO2024254845A1
WO2024254845A1 PCT/CN2023/100677 CN2023100677W WO2024254845A1 WO 2024254845 A1 WO2024254845 A1 WO 2024254845A1 CN 2023100677 W CN2023100677 W CN 2023100677W WO 2024254845 A1 WO2024254845 A1 WO 2024254845A1
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Prior art keywords
pressure
temperature
perfusion
suction
liquid
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Ceased
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PCT/CN2023/100677
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English (en)
French (fr)
Inventor
李芳柄
徐鹏宏
冯冬刚
岑金华
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Zhejiang Yigao Medical Technology Co Ltd
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Zhejiang Yigao Medical Technology Co Ltd
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Priority to PCT/CN2023/100677 priority Critical patent/WO2024254845A1/zh
Priority to EP23941080.6A priority patent/EP4620410A4/en
Publication of WO2024254845A1 publication Critical patent/WO2024254845A1/zh
Priority to US19/006,241 priority patent/US20250127532A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/225—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for for extracorporeal shock wave lithotripsy [ESWL], e.g. by using ultrasonic waves
    • A61B17/2251—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for for extracorporeal shock wave lithotripsy [ESWL], e.g. by using ultrasonic waves characterised by coupling elements between the apparatus, e.g. shock wave apparatus or locating means, and the patient, e.g. details of bags, pressure control of bag on patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00002—Operational features of endoscopes
    • A61B1/00004—Operational features of endoscopes characterised by electronic signal processing
    • A61B1/00006—Operational features of endoscopes characterised by electronic signal processing of control signals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00094—Suction openings
    • A—HUMAN NECESSITIES
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    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/015—Control of fluid supply or evacuation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/26—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor for producing a shock wave, e.g. laser lithotripsy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/74—Suction control
    • A—HUMAN NECESSITIES
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/77—Suction-irrigation systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
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    • A—HUMAN NECESSITIES
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    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0202—Enemata; Irrigators with electronic control means or interfaces
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0204—Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity
    • A61M3/0216—Pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00084—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22079—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with suction of debris
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/007—Auxiliary appliance with irrigation system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3344—Measuring or controlling pressure at the body treatment site
    • A—HUMAN NECESSITIES
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature

Definitions

  • the invention relates to the field of ureteroscopic lithotripsy surgery, and in particular to a constant pressure and temperature control method for a perfusion suction system.
  • the conventional pressure regulation method is to adjust the pressure in the chamber by adjusting the perfusion flow rate, and no suction device is used to adjust the pressure at the same time. Due to the large suction effect of the suction pump, reducing the perfusion flow rate will cause the pressure to drop too quickly and cannot stabilize at the ideal pressure value.
  • the ideal pressure value in the renal pelvis during surgery needs to be 8-12mmHg.
  • the surgical environment is complex and the pressure in the renal pelvis is always in a fluctuating state.
  • the current pressure regulation is extensive and cannot be adjusted to the appropriate ideal pressure.
  • the tissue loss caused by the sudden increase in temperature caused by laser lithotripsy cannot be reduced in time by only reducing the temperature through perfusion and suction circulation. In view of the short duration of the operation and the extremely high temperature, the surgical risk is relatively high.
  • the present invention provides a constant pressure control method for a perfusion and suction system, wherein the perfusion and suction system comprises a sheath, an endoscope, a perfusion device, a suction device, a main control machine, and a pressure sensor; the sheath is provided with a suction channel, the endoscope is inserted into the sheath, and a liquid delivery channel is formed in the endoscope; the pressure sensor is arranged in the endoscope, the sheath or the perfusion pump, the pressure sensor is used to detect the pressure in the body cavity, the perfusion device is connected with the liquid delivery channel to inject the perfusion liquid into the body cavity; the suction device comprises a suction pump and a suction container connected with the suction pump, the suction container is provided with a pressure relief valve, the suction container is connected with the suction channel to extract the liquid in the body cavity, the perfusion device cooperates with the suction device to keep the cavity at a suitable pressure; the main control machine is connected in communication with
  • the constant pressure control method includes the following steps: step 1) presetting the maximum warning pressure value, the minimum warning pressure value, the pressure control value, and the perfusion flow rate gear; step 2) the main control machine controls the perfusion device to send the perfusion liquid into the body cavity, and can control the suction device to extract the liquid in the body cavity: step 3) the pressure detection device collects the pressure in the cavity and transmits it to the main control machine, and the main control machine adjusts the perfusion and suction parameters according to the real-time monitored pressure value and the data change trend of the pressure value, so that the current cavity pressure is balanced at the pressure control value, and the balance state of perfusion and suction is achieved.
  • the perfusion parameters include the perfusion flow rate gear, and the suction parameters include the opening of the pressure relief valve and the suction pressure threshold.
  • the suction pressure threshold is the suction pressure threshold of the suction container preset by the main control machine, and the suction pump is started and stopped by setting the suction pressure threshold; the constant pressure control of the main control machine includes a coarse adjustment mode, a fine adjustment mode and a mixed adjustment mode.
  • the coarse adjustment mode is for When the intracavity pressure exceeds the highest warning pressure value and the lowest warning pressure value, the fine adjustment mode is for the situation that the pressure difference between the intracavity pressure and the pressure control value is at the first level, and the mixed adjustment mode is for the situation that the pressure difference between the intracavity pressure and the pressure control value is at the second level, and the second level of pressure difference is greater than the first level of pressure difference;
  • the coarse adjustment mode includes the following steps: adjusting the perfusion flow gear and opening the pressure relief valve for the situation that the pressure exceeds the high warning pressure value and the lowest warning pressure value;
  • the fine adjustment mode includes the following steps: keeping the perfusion gear in operation, and the pressure relief valve closed, and adjusting the pressure by fine adjustment of the suction pressure threshold;
  • the mixed adjustment mode includes the following steps: by combining the adjustment of the perfusion flow gear, the pressure relief valve and the suction pressure threshold, the fine adjustment of the perfusion flow, the fine adjustment of the pressure relief valve and the fine adjustment of the suction pressure threshold
  • the coarse adjustment mode is started; when the pressure difference exceeds ⁇ 3 mmHg and is within ⁇ 8 mmHg, the fine adjustment mode is started; when the pressure difference is detected to exceed ⁇ 8 mmHg and is within ⁇ 20 mmHg, the mixed adjustment mode is started.
  • the coarse adjustment mode includes the following steps: when the pressure value in the body cavity exceeds the highest warning line, the main control machine controls the reduction of the perfusion flow gear, and controls the suction pressure threshold so that the suction flow>perfusion flow; when the pressure difference in the cavity exceeds the lowest warning line, the perfusion process gear is increased, the pressure relief valve is opened, and the suction pressure threshold is adjusted to the threshold value under the stable state, so as to achieve a rapid balancing effect and make the pressure in the cavity leave the extreme state as soon as possible.
  • the perfusion flow rate gear is kept unchanged, the pressure relief valve is kept closed, the perfusion maintains the current operation, and the uploaded data change trend is observed. If it is in an upward stage, the suction pressure threshold is increased; if it is in a downward trend, the suction pressure threshold is reduced and the reduction is greater than the amplitude of the increase in the suction pressure threshold in the upward stage.
  • the perfusion flow rate is appropriately reduced, and the change trend of the uploaded data is observed. If it is in an ascending stage, the suction pressure threshold is increased.
  • the suction pressure threshold is reduced and the reduction amplitude is smaller than the amplitude of increasing the suction pressure threshold in the ascending stage; in this way, during the data adjustment process, there is an overall trend of increasing the "suction pressure threshold" to achieve a decompression effect; when it is detected that the pressure difference is lower than -8 mmHg and within -20 mmHg, the perfusion flow rate maintains the current operation, the pressure relief valve is opened in stages, and the change trend of the uploaded data is observed. If it is in an ascending stage, the suction pressure threshold is increased.
  • the "suction pressure threshold" is reduced and the reduction amplitude is larger than the amplitude of increasing the suction pressure threshold in the ascending stage; in this way, during the data adjustment process, there is an overall trend of reducing the "suction pressure threshold" to achieve a pressurization effect;
  • the adjustment amplitude of the suction pressure threshold increases as the pressure difference between the intracavity pressure and the pressure control value increases.
  • the present invention provides a constant pressure temperature control method for a perfusion and suction system, the method comprising the constant pressure regulation method and the temperature control method described above;
  • the perfusion device further comprises: a perfusion pump, the perfusion pump being used to pump the perfusion liquid; a normal temperature liquid storage bag, the normal temperature liquid storage bag being used to store the normal temperature perfusion liquid; a low temperature liquid storage bag, the low temperature liquid storage bag being used to store the low temperature perfusion liquid; a normal temperature liquid inlet pipe, the normal temperature liquid storage bag being connected to the normal temperature liquid inlet pipe; a low temperature liquid inlet pipe, the low temperature liquid storage bag being connected to the low temperature liquid inlet pipe; a temperature sensor, which is arranged on the endoscope or the sheath tube to detect the temperature in the body cavity; a mixing pipeline, one end of the mixing pipeline is connected to the outlets of the normal temperature liquid inlet pipe and the low temperature liquid inlet pipe, and the other end is connected to the perfusion pump; a proportional control valve, the proportional control valve is used to control the liquid flow of the normal temperature liquid inlet pipe and the low temperature liquid inlet pipe; the main control machine controls the mixing ratio of the normal temperature perfusion liquid and
  • the present invention provides another constant pressure temperature control method for a perfusion suction system, the method includes the aforementioned constant pressure regulation method and temperature control method, the perfusion device includes: a low temperature perfusion pump, the low temperature perfusion pump is connected to a low temperature liquid inlet pipe; a normal temperature perfusion pump, the normal temperature perfusion pump is connected to the normal temperature liquid inlet pipe, the normal temperature perfusion pump and the low temperature perfusion pump are connected to the liquid outlet pipe after the liquid outlet is merged; the method includes the following steps: step 1) presetting a first predetermined temperature Tmax and a second predetermined temperature Tmin, the normal temperature storage liquid has a first preset temperature t1, and the low temperature storage liquid has a second preset temperature tmin Assume temperature t2; step 2) after each temperature acquisition, compare the acquired temperature T with the first predetermined temperature Tmax and the second predetermined temperature Tmin.
  • the main control machine controls the speed ratio of the normal temperature perfusion pump and the low temperature perfusion pump respectively to adjust the flow rates of the normal temperature liquid inlet pipe and the low temperature liquid inlet pipe; step 3) if it is judged that T reaches the ideal temperature, the temperature control process is stopped. If it does not reach the standard, the speed ratio of the normal temperature perfusion pump and the low temperature perfusion pump is further adjusted in real time according to the temperature difference until it is adjusted to the ideal temperature.
  • the present invention provides a perfusion aspirator, which includes a suction device and a perfusion device, wherein the perfusion device includes a perfusion pump, wherein the perfusion pump is used to pump perfusion liquid; a normal temperature liquid storage bag, wherein the normal temperature liquid storage bag is used to store normal temperature perfusion liquid; a low temperature liquid storage bag, wherein the low temperature liquid storage bag is used to store low temperature perfusion liquid; a normal temperature liquid inlet pipe, wherein the normal temperature liquid storage bag is connected to the normal temperature liquid inlet pipe; a low temperature liquid inlet pipe, wherein the low temperature liquid storage bag is connected to the low temperature liquid inlet pipe; the suction container includes a suction pump, a first negative pressure suction tube, a suction container and a second negative pressure suction tube, wherein one end of the first negative pressure suction tube is connected to the suction pump and the other end is connected to the suction container, and one end of the second negative pressure suction tube is connected to the suction container and the other end
  • the infusion pump, diaphragm pump, and main control unit are integrated.
  • the adjustment range of the suction pressure threshold increases with the increase of the pressure difference between the intracavitary pressure and the pressure control value.
  • the pressure sensor is configured at the distal end of the endoscope or the proximal end of the sheath
  • the temperature sensor is configured at the distal end of the endoscope or the sheath.
  • the present invention realizes real-time regulation of the pressure in the body cavity by setting a pressure relief valve in the suction container and setting the suction pressure threshold, and then realizing the coarse adjustment mode, fine adjustment mode and mixed adjustment mode through the suction device, so that the pressure is dynamically balanced at the pressure control value, reducing the damage of pressure fluctuation to the body cavity tissue; at the same time, the present invention judges the state of the pressure detection value in the body cavity and the data change trend, and dynamically regulates the body cavity pressure in combination with multiple modes. Furthermore, the perfusion suction system provided by the present invention realizes precise control of the temperature in the cavity by controlling the temperature of the perfusion fluid at the source.
  • this embodiment first reduces the excessive requirements for the perfusion flow and the temperature control is more accurate and real-time, reducing the experience requirements of the operator and reducing postoperative complications.
  • the system provided by the present invention timely adjusts the pressure, flow and temperature of the perfusion by dual monitoring of the pressure and temperature in the cavity, effectively improving the safety of the operation and reducing the dangers caused by excessively high or low temperature and pressure during the operation.
  • FIG1 is a schematic structural diagram of the perfusion and suction system provided by the present invention.
  • Figure 2-4 is a process curve diagram of the control method provided by the present invention.
  • FIG5 is a schematic diagram of the structure of the perfusion and suction system provided by the present invention.
  • FIG6 is a schematic diagram of the working principle of the perfusion and suction system provided by the present invention.
  • FIG. 7 is a schematic diagram showing the working principle of the perfusion and suction system provided by the present invention.
  • This embodiment provides an intelligent constant pressure controlled perfusion and suction system, which includes a sheath tube 1, an endoscope 2, a perfusion device, a suction device, a pressure sensor, and a main control machine.
  • the sheath tube 1 also has a suction channel.
  • the suction channel and the main channel are the same channel.
  • the endoscope 2 is inserted into the sheath tube 1, and a liquid delivery channel is formed in the endoscope 2.
  • the perfusion device 10 is connected to the liquid delivery channel to inject the perfusion liquid into the body cavity.
  • the suction device is used to extract the waste fluid and stones in the cavity through the negative pressure of the sheath tube, collect the waste fluid and stones into the suction container through the negative pressure suction tube, and the perfusion device cooperates with the suction device to maintain the cavity at a suitable pressure; specifically, the suction device is connected to the sheath tube 1, and the suction device includes a diaphragm pump, a first negative pressure suction tube 91, a suction container 93 and a second negative pressure suction tube 92, one end of the first negative pressure suction tube 91 is connected to the diaphragm pump, and the other end is connected to the suction container 93, one end of the second negative pressure suction 92 is connected to the suction container 93, and the other end is connected to the sheath tube 1; specifically, during long-term laser operation, the operation time lasts for a long time, the perfusion fluid increases relatively, and the suction device can be used to reduce the pressure in the cavity.
  • the perfusion device includes a liquid inlet tube 6, a liquid storage bag 3 and a perfusion pump 4, wherein the perfusion pump 4 is connected to the liquid storage bag 3 via the liquid inlet tube 6; the perfusion pump 4 is connected to the liquid delivery channel 8 of the endoscope via the liquid outlet tube 7;
  • the suction device includes a suction pump, a first negative pressure suction tube 91, a suction container 93, a second negative pressure suction tube 92 and a pressure sensor.
  • One end of the first negative pressure suction tube 91 is connected to the sheath tube 1, and the other end is connected to the suction container 93.
  • One end of the second negative pressure suction 92 is connected to the suction container 93, and the other end is connected to the suction pump.
  • the pressure sensor is used to detect the intracavitary pressure in the suction container 93.
  • the suction container 93 is provided with a pressure relief valve.
  • the main control machine is communicatively connected with the pressure sensor, the perfusion device and the suction device.
  • the main control machine controls the flow rate and pressure of the perfusion device and the suction device according to the pressure value output by the pressure sensor.
  • the perfusion pump, the suction pump and the main control machine are integrated in the housing 5.
  • the perfusion pump is a peristaltic pump and the suction pump is a diaphragm pump.
  • main control computer can be installed on the endoscope or on the image processor 22 .
  • the pressure sensor can be arranged at the distal end of the endoscope, at the distal end of the sheath, or at the proximal end of the sheath.
  • the pressure sensor 26 is arranged at the proximal end of the sheath, thus solving the problem of high error caused by the long pressure detection pipeline.
  • the sheath is in the cavity, and the doctor will not touch the sheath by mistake, thus avoiding the pressure detection error caused by the doctor's accidental collision with the pressure measurement pipeline.
  • the instantaneous high pressure problem caused by installing the pressure sensor at the distal end of the sheath is solved; the pressure sensor 26 is connected to the main control machine.
  • the system further comprises a display 27 capable of displaying the pressure output value.
  • the present invention provides a constant voltage intelligent control method, the method comprising the following steps:
  • Step 1) The pressure of the pressure detection device is output to the main control machine, and the main control machine compares the pressure with the preset ideal pressure. If the pressure does not meet the ideal pressure requirement, the main control machine controls the parameters of the perfusion suction, such as proportional pressure, temperature and flow rate;
  • Step 2) The pressure detection device is provided with a control button, and the control button can be used to directly control the perfusion device and the suction device to adjust the pressure in the body cavity.
  • the suction device also includes a suction pressure sensor, which is used to detect the intracavity pressure in the suction container 93.
  • the suction container 93 is provided with a pressure relief valve.
  • the main control machine presets a suction pressure threshold. When the pressure of the suction container 93 is greater than the suction pressure threshold, the suction pump stops. When the pressure of the suction container is less than the suction pressure threshold and the current cavity pressure is greater than the "pressure control value -3 mmHg", the suction pump is turned on.
  • the pressure of the suction container is adjusted by changing the suction pressure threshold. Different pressures of the suction container result in different suction flow rates. By adjusting the suction flow rate and the perfusion flow rate, a certain pressure is maintained in the cavity to achieve a dynamic balance between perfusion and suction.
  • the main control machine controls the change of the suction pressure threshold to further control the pressure in the body cavity by controlling the pressure of the suction container.
  • the suction pressure threshold can achieve fine adjustment of the pressure in the body cavity and significantly reduce the pressure fluctuation in the body cavity.
  • the main control unit further presets the highest warning pressure value, the lowest warning pressure value, the pressure control value and the perfusion flow rate gear.
  • the "pressure control value” here refers to the ideal pressure value or pressure range in the preset cavity.
  • the “warning pressure value” here refers to the state where the pressure difference between the pressure in the cavity and the pressure control value exceeds this value.
  • the pressure detection device detects the pressure in the cavity every 0.25s. When the cavity pressure is not at the "pressure control value ⁇ 8mmHg", it means that the pressure is too high or too low than the "pressure control value" at this time, and the pressure difference is too large.
  • the present invention fine-tunes the pressure threshold of the suction container; in summary, the present invention aims to obtain a dynamic balance of pressure in the cavity, and maintains the pressure in the cavity in a dynamic balance state of the pressure control value through a combination of coarse adjustment and fine adjustment.
  • the present invention provides a constant pressure control method for a perfusion suction system, the method comprising the following steps:
  • Step 1) Preset the maximum warning pressure value, the minimum warning pressure value, the pressure control value, and the perfusion flow rate gear;
  • Step 2) The main control machine controls the delivery of the perfusion liquid into the perfusion device and the suction of the suction device;
  • Step 3) The pressure detection device collects the pressure in the cavity and transmits it to the main control machine.
  • the main control machine automatically adjusts the corresponding state system according to the real-time monitored pressure value and the data change trend of the pressure value, so that the current cavity pressure is balanced at the pressure control value; when the data exceeds the standard, the system will automatically adjust its own perfusion and suction state to achieve a balanced state of perfusion and suction as soon as possible while maintaining a certain cavity pressure;
  • the perfusion parameters include the perfusion flow rate gear, and the suction parameters include the opening of the pressure relief valve and the adjustment of the suction pressure threshold;
  • the main control machine pressure regulation mode includes a coarse adjustment mode, a fine adjustment mode and a mixed adjustment mode.
  • the coarse adjustment mode is for extreme pressure in the cavity
  • the fine adjustment mode is for a small pressure difference between the cavity pressure and the pressure control value.
  • the mixed adjustment mode is for a situation where the cavity pressure has not reached an extreme situation and the deviation is large. For example, when the pressure difference between the cavity pressure and the pressure control value is in an extreme situation, such as exceeding ⁇ 20 mmHg, the coarse adjustment mode is started; when the pressure difference exceeds ⁇ 3 mmHg and is within ⁇ 8 mmHg, the fine adjustment mode is started; when it is detected that the pressure difference exceeds ⁇ 8 mmHg and is within ⁇ 20 mmHg, the mixed adjustment mode is started.
  • the pressure control value may be a point value or an interval value.
  • the pressure control value is 10 mmHg, and when the pressure difference between the cavity pressure and the pressure control value is within ⁇ 3 mmHg, the pressure regulation process is started.
  • the coarse adjustment mode When the pressure value in the cavity is detected to exceed the highest warning line, that is, the pressure difference between the cavity pressure and the pressure control value is in an extreme situation, such as greater than 20 mmHg, the coarse adjustment mode is started, the main control machine controls to reduce the perfusion flow gear, and controls the suction pressure threshold so that the suction flow>perfusion flow.
  • the coarse adjustment mode is started, the perfusion process gear is adjusted to the maximum, the pressure relief valve is opened, and the suction pressure threshold is adjusted to the threshold value in the stable state, so as to achieve a rapid balance effect and enable the device to leave the current state as soon as possible.
  • the suction pressure threshold is adjusted to the suction pressure threshold in the stable state.
  • the suction pressure threshold in the stable state refers to the corresponding suction pressure threshold when the cavity pressure recorded by the main control machine reaches the pressure control value interval.
  • the suction pressure threshold also needs to be adjusted in real time according to the changing trend of the data.
  • the pressure difference exceeds -3mmHg and is within -8mmHg
  • the perfusion flow rate gear is kept unchanged
  • the pressure relief valve is kept closed, the perfusion is maintained in the current operation, and the change trend of the uploaded data is observed.
  • the suction pressure threshold is increased, and if it is in a downward trend, the suction pressure threshold is reduced and the reduction amplitude is greater than the amplitude of increasing the suction pressure threshold in the rising stage. In this way, in the process of data adjustment, there is an overall trend of reducing the suction pressure threshold, and the pressurization effect is achieved in a fine-tuning manner.
  • the pressure difference exceeds 3mmHg and is within 8mmHg, the perfusion is maintained in the current gear operation, and the change trend of the uploaded data is observed.
  • the suction pressure threshold is increased, and if it is in a downward trend, the “suction pressure threshold” is reduced and the reduction amplitude is less than the amplitude of increasing the suction pressure threshold in the rising stage. In this way, in the process of data adjustment, there is an overall trend of increasing the "suction pressure threshold" to achieve a decompression effect.
  • the current pressure detection value state and the data change trend are judged, and the suction pressure threshold is adjusted to make it show an upward or downward trend, reducing the damage to the body cavity caused by large pressure fluctuations.
  • the mixed adjustment mode is started.
  • the perfusion flow rate gear By combining the adjustment of the perfusion flow rate gear, the pressure relief valve and the suction pressure threshold, the perfusion flow rate fine adjustment, the pressure relief valve fine adjustment and the suction pressure threshold fine adjustment are combined to act on the intracavitary pressure together to achieve the effect of pressurization or decompression.
  • the perfusion flow rate gear is appropriately reduced, and the change trend of the uploaded data is observed. If it is in an upward stage, the suction pressure threshold is increased.
  • the "suction pressure threshold" is reduced and the reduction amplitude is less than the amplitude of increasing the suction pressure threshold in the upward stage; in this way, in the process of data adjustment, there is an overall increase in the "suction pressure threshold". to achieve a decompression effect; when it is detected that the pressure difference exceeds -8mmHg and is within -20mmHg, the perfusion flow maintains the current operation, the pressure relief valve is opened in stages, and the change trend of the uploaded data is observed.
  • the suction pressure threshold is increased; if it is in a downward trend, the "suction pressure threshold" is reduced and the reduction amplitude is greater than the amplitude of increasing the suction pressure threshold in the upward stage; in this way, during the data adjustment process, there is an overall trend of reducing the "suction pressure threshold" to achieve a pressurization effect; in this embodiment, the adjustment amplitude of the suction pressure threshold increases with the increase of the pressure difference between the intracavitary pressure and the pressure control value. In this way, the combination of coarse adjustment and fine adjustment is achieved through the amplitude of the suction pressure threshold, so that the intracavitary pressure quickly reaches the pressure control value, avoiding tissue damage caused by excessive pressure fluctuations in the body.
  • the relationship between the negative pressure suction flow rate (unit: ml/min) and the suction pressure threshold is statistically divided into 12 categories. They are -5mmhg, -10mmhg, -15mmhg, -20mmhg, -25mmhg, -30mmhg, -35mmhg, -40mmhg, -45mmhg, -50mmhg, -60mmhg, -70mmhg. This value is generally used when the system is turned on. The system defaults to the initial value. Later, the balance point value will be updated with the dynamic balance process to achieve the effect of dynamic balance.
  • the pressure difference Pa (unit: mmhg) between the pressure in the cavity and the pressure control value is counted and then classified.
  • the newly collected cavity pressure data is compared with the historical data, so as to quickly achieve a dynamic balance between perfusion and suction by adjusting the perfusion, suction and pressure relief valves according to the changing trend of the historical data.
  • this embodiment provides the following processing method:
  • the perfusion device of this embodiment includes a perfusion pump, a normal temperature liquid storage bag 31, a low temperature liquid storage bag 33, a liquid inlet pipe, a liquid outlet pipe 7, a temperature sensor 11 and.
  • the sheath 1 defines an instrument entry channel to facilitate the insertion of the endoscope 2 therein.
  • the sheath 1 provided in this embodiment is a three-channel sheath, which includes a central channel, a pressure measurement channel, and a suction channel.
  • the central channel is used for inserting the endoscope 2, and the suction channel is used to connect with the suction device.
  • the endoscope 2 is inserted into the sheath 1.
  • the camera at the head end of the endoscope 2 is used to collect images in the cavity.
  • the images are processed by the image processor 22 and output to the display for the doctor to observe the internal environment of the cavity.
  • a liquid delivery channel is formed in the endoscope 2, and the liquid delivery channel is used for the inflow of perfusion liquid.
  • the endoscope 2 is connected to the image processor 22 via an endoscope harness 21.
  • the perfusion pump is used to pump the perfusion liquid; the normal temperature liquid storage bag 31 is used to store the normal temperature perfusion liquid; the low temperature liquid storage bag 32 is used to store the low temperature perfusion liquid, the normal temperature liquid storage bag 31 and the low temperature liquid storage bag 33 are connected to the perfusion pump through the liquid inlet pipe; the perfusion pump is connected to the liquid delivery channel of the endoscope through the liquid outlet pipe 7.
  • the low temperature liquid storage bag can be low temperature physiological saline directly installed in the liquid storage bag, or the normal temperature liquid storage bag can be placed in a refrigerator, the temperature of the refrigerator can be adjusted, for example, the temperature of the refrigerator can be controlled by the main control computer, and a low temperature liquid storage bag can be obtained.
  • the temperature sensor 11 is arranged on the endoscope or the sheath tube to detect the temperature in the body cavity; the main control machine controls the mixing ratio of the normal temperature perfusion liquid and the low temperature perfusion liquid according to the temperature signal obtained by the temperature sensor, and then controls the supply temperature of the perfusion liquid; in this way, when the temperature caused by laser lithotripsy is too high, the main control machine controls the mixing ratio of the normal temperature perfusion liquid and the low temperature perfusion liquid, and delivers the mixed perfusion liquid of the predetermined temperature to the cavity, such as the lesion site in the renal pelvis, through the perfusion pump to take away the overheating heat generated by the lithotripsy process.
  • the perfusion liquid can wash away the bleeding and stone powder during the operation, keep the field of view of the endoscope 2 clear, and can also open the cavity to maintain the space required for the operation.
  • the instantaneous heat of the laser will cause the liquid in the cavity to boil.
  • the doctor needs to adjust the rotation speed of the perfusion pump to increase the flow rate of the perfusion fluid in order to remove the heat through a large flow of normal temperature perfusion fluid.
  • Excessive perfusion volume will cause excessive pressure in the cavity, so the existing technology needs to rely on a suction device to speed up the circulation of the perfusion fluid.
  • the instantaneous pressure in the body is still high and is limited by the size of the inlet and outlet pipes, and the increase in its flow rate has limitations.
  • the temperature control method provided in this embodiment can adjust the temperature of the perfusion liquid in real time according to the temperature difference between the collected temperature and the ideal temperature. Firstly, the cleaning advantage of the normal temperature perfusion liquid is taken into account while achieving the purpose of temperature control, so as to avoid only using low temperature perfusion liquid and ignoring the perfusion advantage of the normal temperature perfusion liquid. Secondly, when the temperature in the cavity is too high, the low temperature perfusion liquid can be directly pumped into the cavity and the heat generated by the laser can be quickly taken away by the flow rate of the perfusion liquid.
  • the perfusion liquid is cooled before being delivered to the liquid delivery channel so that the cooled liquid is delivered to the cavity to take away the heat.
  • delivering liquid below 5°C into the liquid delivery channel takes away more heat than the normal temperature perfusion liquid.
  • the speed is significantly accelerated, and the ideal temperature can be reached in a short time, which solves the technical problem of short surgical course and slow cooling speed; thirdly, with the pumping of low-temperature perfusion fluid, the temperature in the cavity also begins to drop.
  • the mixing ratio of low-temperature perfusion fluid and high-temperature perfusion fluid is controlled according to the difference between the collected temperature and the ideal temperature, so that the temperature control process can stably reach the ideal temperature and avoid supercooled liquid from entering the body to cause frostbite;
  • this control method firstly accurately controls the temperature of the perfusion fluid in the liquid inlet tube, and at the same time takes into account the difference between the real-time temperature and the ideal temperature in the cavity, adjusts the temperature of the perfusion fluid in real time, and dynamically controls the temperature of the lesion site in real time and accurately.
  • the perfusion and suction system includes a normal temperature liquid storage bag 31, a low temperature liquid storage bag 33, a normal temperature liquid inlet pipe 61, a low temperature liquid inlet pipe 62, a mixing pipeline 63, and a proportional control valve 10.
  • the normal temperature liquid storage bag 31 stores normal temperature perfusion liquid; the low temperature liquid storage bag 33 is used to store low temperature perfusion liquid; the normal temperature liquid storage bag 31 is connected to the normal temperature liquid inlet pipe 61; the low temperature liquid storage bag 33 is connected to the low temperature liquid inlet pipe 62, one end of the mixing pipeline 63 is connected to the outlets of the normal temperature liquid inlet pipe 61 and the low temperature liquid inlet pipe 62, and the other end is connected to the perfusion pump, and the proportional control valve 10 is used to control the liquid flow rate of the normal temperature liquid inlet pipe 61 and the low temperature liquid inlet pipe 62; in this way, the temperature of the perfusion liquid and the temperature in the cavity can be accurately regulated through the perfusion and suction system.
  • the doctor can connect the normal temperature liquid storage bag 31 with the mixing pipeline 63 through the proportional control valve 10, so that the normal temperature perfusion liquid can be directly delivered to the cavity to clean up the bleeding, stone powder, etc. during the operation.
  • the doctor can connect the low temperature liquid storage bag 33 with the mixing pipeline 63 through the proportional control valve 10. In this way, when the laser lithotripsy causes the temperature of the lesion site to be too high, for example, the liquid in the cavity directly boils, the low temperature perfusion liquid is directly delivered to the cavity through the proportional control valve to quickly take away the heat generated by the laser.
  • the third embodiment as the perfusion liquid is poured in, the temperature difference between the temperature in the cavity and the ideal temperature gradually decreases.
  • the doctor can adjust the proportional control valve 10 according to the temperature difference between the temperature in the cavity and the ideal temperature so that the mixed ratio of the normal temperature perfusion liquid and the low temperature perfusion liquid is obtained to obtain a mixed perfusion liquid with a specific temperature to the liquid delivery channel, thereby avoiding technical problems caused by overcooling or overheating of the perfusion liquid and achieving precise temperature control.
  • the normal temperature liquid inlet pipe 61 and the low temperature liquid inlet pipe 62 are respectively provided with a proportional control valve 10.
  • the proportional control valve 10 is a three-way valve, which connects the normal temperature liquid inlet pipe 61, the low temperature liquid inlet pipe 62 and the mixing pipeline 63; all of the above can realize the above temperature control process.
  • the three-way valve is a PID control valve.
  • This embodiment provides a temperature control method for a perfusion suction system, the method comprising the following steps:
  • Step 1) Preset a first preset temperature Tmax and a second preset temperature Tmin, that is, establish a standard ideal temperature range; the room temperature storage liquid has a first preset temperature t1, and the low temperature storage liquid has a second preset temperature t2; specifically, Tmax is 40°C, Tmin is 30°C, the first preset temperature t1 is 25°C, and the second preset temperature t2 is 0-5°C
  • Step 2) After each temperature collection, the main control machine compares the collected temperature T with the first predetermined temperature Tmax and the second predetermined temperature Tmin. If the collected temperature T is higher than the first predetermined temperature Tmax, the control valve connects the low-temperature liquid storage bag 33 with the mixing pipeline 63 or controls the mixing ratio of the normal temperature liquid inlet pipe 61 and the low temperature liquid inlet pipe 62 according to the temperature difference between the collected temperature and the required temperature, thereby controlling the output liquid temperature of the mixing pipeline 63; if the collected temperature T is higher than the second predetermined temperature Tmin, the normal temperature liquid storage bag 31 is connected with the mixing pipeline 63;
  • Step 3 If it is determined that the collected temperature T reaches the ideal temperature between 30°C and 40°C, the temperature control process is stopped. If it does not reach the standard, the opening of the proportional control valve 10 is further adjusted in real time according to the temperature difference between the collected temperature T and the ideal temperature until it is adjusted to the ideal temperature to obtain a dynamic balance of temperature.
  • the heat in the cavity is quickly removed by speeding up the number of cycles of the perfusion flow and the suction flow, while avoiding the damage caused by excessive perfusion pressure.
  • the low-temperature perfusion liquid provided in this embodiment can achieve perfusion of a small flow of perfusion liquid without causing the problem of excessive pressure.
  • the perfusion and suction system provided in this embodiment significantly reduces the number of cycles and liquid flow rate because the temperature of the perfusion fluid is controllable, thereby avoiding tissue damage caused by high flow and high pressure, and the surgical process is gentler and more delicate, and the temperature is controllable.
  • the temperature sensor 11 is mounted on the endoscope 2 or the sheath 1.
  • the temperature sensor 11 is installed at the head end of the endoscope to collect the temperature in the cavity in real time.
  • the temperature measurement signal can be directly fed back to the main control machine; it can also be transmitted to the electronic endoscope 2 host, and then the electronic endoscope 2 host feeds back the signal to the perfusion and suction host.
  • the temperature of the lesion site of the human body can be detected in real time.
  • the proportional control valve 10 is disposed in the perfusion suction host to shorten the travel distance of the low-temperature perfusion liquid.
  • the perfusion suction system includes a low-temperature perfusion pump and a high-temperature perfusion pump, the low-temperature perfusion pump is connected to the low-temperature liquid inlet pipe 62, the normal temperature perfusion pump is connected to the normal temperature liquid inlet pipe, and the normal temperature perfusion pump and the low temperature perfusion pump are connected to the liquid outlet pipe after the liquid outlets merge, so that the speed ratio of the normal temperature perfusion pump and the low temperature perfusion pump can be adjusted in real time according to the temperature difference between the collected temperature and the ideal temperature, and a variety of perfusion methods can also be achieved.
  • the low temperature perfusion pump and the high temperature perfusion pump are both peristaltic pumps, and the temperature and flow rate of the mixed perfusion liquid are controlled by adjusting the speed ratio of the two sets of peristaltic pumps through the perfusion suction host.
  • This embodiment further provides a temperature control method for a perfusion suction system, the method comprising the following steps:
  • Step 1) Preset a first preset temperature Tmax and a second preset temperature Tmin, wherein the room temperature storage liquid has a first preset temperature t1, and the low temperature storage liquid has a second preset temperature t2;
  • Step 2 After each temperature acquisition, the acquisition temperature T is compared with the first predetermined temperature Tmax and the second predetermined temperature Tmin.
  • the main control machine controls the speed ratio of the normal temperature perfusion pump and the low temperature perfusion pump to adjust the flow rate of the normal temperature liquid inlet pipe 61 and the low temperature liquid inlet pipe 62;
  • T reaches the ideal temperature
  • the temperature control process is stopped. If it does not reach the standard, the speed ratio of the normal temperature perfusion pump and the low temperature perfusion pump is further adjusted in real time according to the temperature difference until the ideal temperature is adjusted.
  • the perfusion pump, the diaphragm pump of the suction device and the main control machine are integrated, and the perfusion suction host is used to control the flow and pressure of perfusion and suction and the temperature of the perfusion liquid, and the equipment is more streamlined and easy to operate.
  • the inlet pipe and the outlet pipe can be wrapped with insulation material.
  • the main control machine is connected to the pedal member 100 via a pedal cable 101, and when the doctor has difficulty operating the main control machine with his hands during surgery, the doctor can control the perfusion and suction system via the pedal member.
  • the system provided by the present invention timely adjusts the perfusion pressure, flow rate and temperature by dual monitoring of the pressure and temperature in the cavity, thereby effectively improving the safety of the operation and reducing the temperature during the operation and the risks caused by excessively high or low pressure.
  • the perfusion suction system provided by the present invention realizes precise control of the temperature in the cavity by controlling the temperature of the perfusion fluid at the source. Compared with relying solely on the perfusion flow adjustment, this embodiment first reduces the excessively high requirements for the perfusion flow and the temperature control is more precise and real-time, thereby reducing the operator's experience requirements and reducing postoperative complications.

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Abstract

一种灌注吸引系统的恒压控温方法，恒压控温方法包括恒压调控方法以及控温方法，恒压调控方法包括如下步骤：压力检测装置对腔体内压力进行采集并输送至主控机，主控机根据实时监测到的压力值以及压力值的数据变化趋势，调节灌注参数与吸引参数，使当前腔体内压力平衡在压力控制值，实现灌注与吸引的平衡状态，灌注参数包括灌注流量档位，吸引参数包括泄压阀的开启与吸引压力阈值，吸引压力阈值为主控机预设的吸引容器的吸引压力阈值，通过设定吸引压力阈值来控制吸引泵的启停；主控机调压模式包括粗调模式，精调模式以及混合调节模式。

Description

一种灌注吸引系统的恒压及控温方法 技术领域
本发明涉及输尿管软镜碎石手术领域，具体涉及一种灌注吸引系统的恒压及控温方法。
 背景技术
常规的输尿管软镜碎石手术中，结石的粉末及肾盂内血尿可导致视野模糊，需要灌注冲洗液保持视野清晰，但同时肾盂内压会因为灌注过快、回流不畅而出现明显升高，造成感染的尿液、细菌及内毒素进入血液及淋巴循环，导致患者术后出现发热、全身炎症反应综合征，甚至引发致命性的尿源性脓毒血症。为预防软镜术中肾盂压力过高所致之严重感染，需要术中控制肾盂内压力在安全范围，进一步需要根据术中肾盂压力反馈性地调节灌流速度和/或负压吸引值的高低，所采用的测压方法能否实时、准确地对肾盂压力进行测定，是保证测压控压系统具备良好性能和手术操作安全的基石。
目前常规的采用调压方法为通过调整灌注流量来调节腔室内压力，且并未采用吸引装置同时调节压力。由于吸引泵的抽吸作用较大，降低灌注流量会造成压力下降过快无法稳定处于理想压力值。手术时肾盂内的压力理想压力值需要在8-12mmHg，手术环境复杂，肾盂内的压力始终处于波动状态，目前针对压力的调控粗放且无法调整其处于合适的理想压力。此外，激光碎石术引起的温度骤高造成的组织损失，仅通过灌注吸引循环来降低温度已经无法及时将温度降低，鉴于手术时长短且温度极高的情况，手术风险较大。
 发明内容
第一方面，本发明提供一种灌注吸引系统的恒压调控方法，所述的灌注吸引系统包括鞘管、内窥镜、灌注装置、吸引装置、主控机、压力传感器；所述鞘管内具有吸引通道，所述内窥镜插置在鞘管内，所述内窥镜内形成送液通道；所述压力传感器配置在内窥镜、鞘管或灌注泵内，所述压力传感器用于检测体腔内的压力，所述灌注装置与送液通道连通以用于将灌注液注入体腔；所述吸引装置包括吸引泵以及与吸引泵连接的吸引容器，所述吸引容器设有泄压阀，所述的吸引容器与吸引通道连通以用于将体腔内液体抽出，所述灌注装置与吸引装置配合以保持腔内处于合适压力；所述主控机与压力传感器、灌注装置以及吸引装置通信连接；
所述的恒压调控方法包括如下步骤：步骤1）预设最高警戒压力值、最低警戒压力值、压力控制值、灌注流量档位；步骤2）主控机控制灌注装置将灌注液送入体腔，且能够控制吸引装置将体腔内液体抽出：步骤3）压力检测装置对腔体内压力进行采集并输送至主控机，所述主控机根据实时监测到的压力值以及压力值的数据变化趋势，调节灌注与吸引参数，使当前腔内压力平衡在压力控制值，实现灌注与吸引的平衡状态，所述灌注参数包括灌注流量档位，所述的吸引参数包括泄压阀的开启与吸引压力阈值，所述的吸引压力阈值为主控机预设的吸引容器的吸引压力阈值，通过设定吸引压力阈值来控制吸引泵的启停；所述主控机恒压调控包括粗调模式，精调模式以及混合调节模式，所述的粗调模式针对腔内压力超出了最高警戒压力值与最低警戒压力值，所述的精调模式针对腔内压力与压力控制值的压差处于第一等级的情形，所述的混合调节模式针对腔内压力与压力控制值的压差处于第二等级的情形，所述的第二等级的压差大于第一等级的压差；所述的粗调模式包括如下步骤：调节灌注流量档位以及开启泄压阀的方式来针对压力超过高警戒压力值、最低警戒压力值的情形；所述的精调模式包括如下步骤：保持灌注档位维持运转，且泄压阀保持关闭，通过对吸引压力阈值的精调来进行压力调节；所述的混合调节模式包括如下步骤：通过对灌注流量档位、泄压阀与吸引压力阈值的调节结合，将灌注流量精调、泄压阀精调与吸引压力阈值的精调相结合来共同作用于腔内压力，达到增压或减压的效果。
在一些实施例中，当腔内压力与压力控制值的压差超出±20mmHg，启动粗调模式；当压差超出±3mmHg且处于±8mmHg以内时，启动精调模式；当检测到压差超出±8mmHg且处于±20mmHg以内时，启动混合调节模式。
在一些实施例中，所述的粗调模式包括如下步骤，当体腔内压力值超出了最高警戒线，主控机控制降低灌注流量档位，控制吸引压力阈值使得吸引流量>灌注流量，当腔内压力的压差超出了最低警戒线，将增加灌注流程档位，开启泄压阀，并将吸引压力阈值调节到稳定状态下的阀值，达到快速平衡效果，使腔体内压力尽快脱离极端状态。
在一些实施例中，当压差超出-3mmHg且处于-8mmHg以内，保持灌注流量档位不变，保持泄压阀关闭，灌注维持当前运行，观察上传的数据变化趋势，如果处于上升阶段，增加吸引压力阈值，如果处于下降趋势，减小吸引压力阈值且减小幅度大于上升阶段增加吸引压力阈值的幅度，如此，在数据调整的过程中，整体有降低吸引压力阈值的趋势，以精调的方式达到增压效果；当压差超出3mmHg且处于8mmHg以内，灌注维持当前档位运行，观察上传的数据变化趋势，如果处于上升阶段，增加“吸引压力阈值”，如果处于下降趋势，减小“吸引压力阈值”且减小幅度小于上升阶段增加吸引压力阈值的幅度，在数据调整的过程中，整体有增加“吸引压力阈值”的趋势，达到减压效果。
在一些实施例中，当检测到压差超出8mmHg且处于20mmHg以内时，适当减小灌注流量，观察上传的数据变化趋势，如果处于上升阶段，增加吸引压力阈值，如果处于下降趋势，减小“吸引压力阈值”且减小的幅度小于上升阶段增加吸引压力阈值的幅度；这样在数据调整的过程中，整体有增加“吸引压力阈值”的趋势，达到减压效果；当检测到压差低于-8mmHg且处于-20mmHg以内时，灌注流量维持当前运行，阶段性开启泄压阀，观察上传的数据变化趋势，如果处于上升阶段，增加吸引压力阈值，如果处于下降趋势，减小“吸引压力阈值”且减小的幅度大于上升阶段增加吸引压力阈值的幅度；这样在数据调整的过程中，整体有减小“吸引压力阈值”的趋势，达到增压效果；
在一些实施例中，吸引压力阈值的调节幅度随着腔内压力与压力控制值的压差的增大而增大。
第二方面，本发明提供一种灌注吸引系统的恒压控温方法，该方法包括前述所述的恒压调控方法以及控温方法；
所述的灌注装置还包括：灌注泵，所述灌注泵用于泵送灌注液；常温储液袋，所述常温储液袋用于储存常温灌注液；低温储液袋，所述低温储液袋用于储存低温灌注液；常温进液管，所述常温储液袋与常温进液管连接；低温进液管，所述低温储液袋与低温进液管连接；温度传感器，其设置在内窥镜或鞘管上以检测体腔内的温度；混合管路，所述混合管路一端与常温进液管和低温进液管的出口连通，另一端与灌注泵连接；比例控制阀，所述比例控制阀用于控制常温进液管与低温进液管的液体流量；所述主控机根据温度传感器获取的温度信号控制常温灌注液与低温灌注液的混合比例进而来控制灌注液的供给温度；所述控温方法包括如下步骤：步骤1）预设第一预定温度Tmax和第二预定温度Tmin，所述的常温储存液具有第一预设温度t1，所述的低温储存液具有第二预设温度t2；步骤2）在每进行一次温度采集后，将采集温度T与第一预定温度Tmax和第二预定温度Tmin进行比较，采集温度T高于第一预定温度Tmax后或低于第二预定温度Tmin后，控制阀根据采集温度与需要达到的温度之间的温度差，连通常温储液袋与混合管路、连通低温储液袋与混合管路或控制常温进液管和低温进液管的混合比例，进而控制混合管路的输出液体温度；4）若判断T达到理想温度后，则停止控温流程，若未达标，则进一步根据温度差实时调节比例控制阀的开度，直至调节至理想温度。
第三方面，本发明提供另一种灌注吸引系统的恒压控温方法，该方法包括前述所述的恒压调控方法以及控温方法，所述灌注装置包括：低温灌注泵，所述低温灌注泵与低温进液管连接；常温灌注泵，所述常温灌注泵与常温进液管连接，常温灌注泵与低温灌注泵的出液口汇合后与出液管连通；该方法包括如下步骤：步骤1）预设第一预定温度Tmax和第二预定温度Tmin，所述的常温储存液具有第一预设温度t1，所述的低温储存液具有第二预设温度t2；步骤2）在每进行一次温度采集后，将采集温度T与第一预定温度Tmax和第二预定温度Tmin进行比较，采集温度T高于第一预定温度Tmax后或低于第二预定温度Tmin后，主控机分别控制常温灌注泵与低温灌注泵的转速比例来调节常温进液管和低温进液管的流量；步骤3）若判断T达到理想温度后，则停止控温流程，若未达标，则进一步根据温度差实时调节常温灌注泵与低温灌注泵的转速比例，直至调节至理想温度。
第四方面，本发明提供一种灌注吸引器，所述灌注吸引器包括吸引装置与灌注装置，所述的灌注装置包括灌注泵，所述灌注泵用于泵送灌注液；常温储液袋，所述常温储液袋用于储存常温灌注液；低温储液袋，所述低温储液袋用于储存低温灌注液；常温进液管，所述常温储液袋与常温进液管连接；低温进液管，所述低温储液袋与低温进液管连接；所述的吸引容器包括吸引泵、第一负压吸引管、吸引容器和第二负压吸引管，所述第一负压吸引管一端与吸引泵连接，另一端与吸引容器连接，所述的第二负压吸引管一端与吸引容器连接，另一端与鞘管连接；主控机，所述主控机与灌注装置以及吸引装置通信连接，所述的主控机通过控制灌注装置和吸引装置来控制体腔内的温度和压力。
在一些实施例中，所述的灌注泵、隔膜泵、主控机集成安装。在一些实施例中，吸引压力阈值的调节幅度随着腔内压力与压力控制值的压差的增大而增大。
在一些实施例中，所述的压力传感器配置在内窥镜的远端或鞘管的近端，所述的温度传感器配置在内窥镜或鞘管的远端。
本发明通过在吸引容器设置泄压阀以及设定吸引压力阈值，进而通过吸引装置来实现粗调模式、精调模式以及混合调节模式，实现了实时调节体腔内的压力，使得压力动态平衡在压力控制值，降低了压力波动对对体腔组织的损伤；同时本发明判断当体腔内压力检测值状态以及数据变化趋势，结合多种模式动态调控体腔压力。进一步地，本发明提供的灌注吸引系统通过对源头的灌注液的温度进行控制来实现对腔体内温度的精准控制，相较于仅依靠灌注流量调节，本实施方式首先降低了对灌注流量的过高要求且温度的控制更为精准且实时，降低术者的经验要求、降低术后的并发症。本发明提供的系统通过对腔体内压力温度双重监测及时调整灌注的压力、流量以及温度，有效提高手术的安全性，降低手术过程的温度以及压力过高或过低带来的危险。
 附图说明
图1为本发明提供的灌注吸引系统的结构示意图；
图2-4为本发明提供的调控方法的过程曲线图；
图5为本发明提供的灌注吸引系统的结构示意图；
图6为本发明提供的灌注吸引系统的工作原理示意图；
图7为本发明提供的灌注吸引系统的工作原理示意图。
 具体实施方式
在本发明的描述中，需要理解的是，术语“上”、“下”、“前”、“后”、“左”、“右”、“内”、“外”、“近”、“远”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。此外，限定有“第一”、“第二”的特征可以明示或者隐含地包括一个或者更多个该特征。
实施例1
请参阅图1，本实施方式提供一种智能恒压调控灌注吸引系统，该系统包括鞘管1、内窥镜2、灌注装置、吸引装置、压力传感器以及主控机，所述鞘管1还具有吸引通道，在本实施例中，所述吸引通道与主通道为同一通道；所述内窥镜2插置在鞘管1内，所述内窥镜2内形成送液通道；所述灌注装置10与送液通道连通以用于将灌注液注入体腔.
所述吸引装置用于将腔内废液及结石通过鞘管负压抽出，通过负压吸引管将废液及结石收集到吸引容器内，灌注装置与吸引装置配合以保持腔内处于合适压力；具体地，所述吸引装置与鞘管1连接，所述吸引装置包括隔膜泵、第一负压吸引管91、吸引容器93和第二负压吸引管92，所述第一负压吸引管91一端与隔膜泵连接，另一端与吸引容器93连接，所述的第二负压吸引92一端与吸引容器93连接，另一端与鞘管1连接；具体地，在长时间激光操作时，手术时间持续长，则灌注液则相对的增多，可以吸引装置来降低腔体内压力。
所述灌注装置包括进液管6、储液袋3以及灌注泵4，所述灌注泵4通过进液管6与储液袋3连接；所述的灌注泵4通过出液管7与内窥镜的8送液通道连通；
所述的吸引装置包括吸引泵、第一负压吸引管91、吸引容器93和第二负压吸引管92与压力传感器，所述第一负压吸引管91一端与鞘管1连接，另一端与吸引容器93连接，所述的第二负压吸引92一端与吸引容器93连接，另一端与吸引泵连接，所述压力传感器用于检测吸引容器93内的腔内压力，所述吸引容器93设有泄压阀。
所述主控机与压力传感器、灌注装置以及吸引装置通信连接，所述主控机根据压力传感器输出的压力值控制灌注装置以及吸引装置的流量以及压力，在本实施中，所述灌注泵、吸引泵与主控机集成安装在壳体5，可选地，所述的灌注泵为蠕动泵，所述的吸引泵为隔膜泵。
可以理解的是，所述的主控机可以安装在内窥镜上，也可以安装在图像处理器22上。
所述压力传感器可以设置在内窥镜的远端、也可以设置在鞘管的远端，更可以设置在鞘管的近端，在本实施例中，所述的压力传感器26设置在鞘管的近端，如此，解决了压力检测管路过长误差高的问题，且鞘管在实际操作中基于均处于腔体内，医生不会误触碰到鞘管，因此避免了医生误碰撞测压管路引起的压力检测误差。同时解决了将压力传感器安装在鞘管远端带来的瞬时高压问题；所述压力传感器26与主控机连接。
所述系统还包括显示器27，所述显示器27能够显示压力输出值。
在本发明的一个实施例中，本发明提供一种恒压智能调控方法，该方法包括如下步骤：
步骤1）所述压力检测装置的压力输出至主控机，所述主控机将压力与预设的理想压力进行比对，若压力不满足理想压力要求，则通过主控机控制灌注吸引的参数，比例压力、温度以及流量；
步骤2）所述压力检测装置设有控制按键，所述控制按键可以用于直接控制灌注装置与吸引装置来调控体腔内压力。
在本发明一个优选实施例中，所述的吸引装置还包括吸引压力传感器，所述吸引压力传感器用于检测吸引容器93内的腔内压力，所述吸引容器93设有泄压阀，主控机预设吸引压力阈值，当吸引容器93的压力大于吸引压力阈值，吸引泵停止，当吸引容器的压力小于吸引压力阈值，且当前腔压大于“压力控制值-3mmHg”开启吸引泵，通过对吸引压力阈值的改变调整吸引容器的压力，所述吸引容器的压力不同导致吸引流量的不同，通过吸引流量与灌注流量的调节使得腔内维持一定的压力达到灌注与吸引的动态平衡。
所述主控机控制吸引压力阈值的变化以通过控制吸引容器的压力进一步控制体腔内的压力，相较于直接通过吸引泵的抽吸压力大小，通过吸引压力阈值可以实现对体腔内的压力精调以及显著降低了体腔内的压力波动。
主控机进一步预设最高警戒压力值、最低警戒压力值、压力控制值以及灌注流量档位，此处的“压力控制值”是指预设腔体内的理想压力值或压力区间，此处的“警戒压力值”是指腔体内的压力与压力控制值的压差超出该值的状态，压力检测装置每0.25s检测一次腔体内的压力，当腔体压力不处于“压力控制值±8mmHg”，说明此时压力比“压力控制值”过高或过低，压差过大，此时需要通过粗调的方式对压力进行大范围的调节，例如通过对灌注档位的调节以及泄压阀的调节来快速调节腔体内压力使其接近或到达压力控制值。然而当腔体内压力处于“压力控制值±8mmHg”，腔体内压力与压力控制值压差小，如继续通过粗调例如灌注档位或泄压阀调节，则容易导致腔体内压力走向另一个极端，难以到达或接近控制值。此外，吸引装置的吸引泵的吸引压力较大，若通过吸引泵直接调节压力则同样难以达到精调的效果，基于此，本发明通过对吸引容器的压力阈值进行精调；综上，本发明旨在获得腔体内的压力动态平衡，通过粗调与精调的结合将腔体内的压力维持在压力控制值的动态平衡状态。
本发明提供一种灌注吸引系统的恒压调控方法，该方法包括如下步骤：
步骤1）预设最高警戒压力值、最低警戒压力值、压力控制值、灌注流量档位；
步骤2）主控机控制灌注装置灌注液的送入和吸引装置的吸出；
步骤3）压力检测装置对腔体内压力进行采集并输送至主控机，所述主控机根据实时监测到的压力值以及压力值的数据变化趋势，对相应的状态系统进行自动调整，使当前腔内压力平衡在压力控制值；当数据超标时，系统会自动调节自己的灌注与吸引状态，尽快的达到维持一定腔内压力的状态下，灌注与吸引的平衡状态；所述灌注参数包括灌注流量档位，所述的吸引参数包括泄压阀的开启与吸引压力阈值的调节；
所述主控机调压模式包括粗调模式，精调模式以及混合调节模式，所述的粗调模式针对腔内压力处于极端情况，所述的精调模式针对腔内压力偏离压力控制值的压差较小；所述的混合调节模式针对腔内压力并未达到极端情况同时偏离值较大的情形，例如，腔内压力与压力控制值的压差处于极端情况例如超出±20mmHg，启动粗调模式；当压差超出±3mmHg且处于±8mmHg以内时启动精调模式；当检测到压差超出±8mmHg且处于±20mmHg以内时，启动混合调节模式。
所述的压力控制值可以为一个点值，也可以为一个区间值。在本发明的一些实施例中，请参阅图2-4，所述的压力控制值为10mmhg，当腔内压力与压力控制值的压差为±3mmHg以内时，启动调压流程。
请参阅图2，检测到腔内压力值超出了最高警戒线，即腔内压力与压力控制值的压差处于极端情况例如大于20mmHg，启动粗调模式，主控机控制降低灌注流量档位，控制吸引压力阈值使得吸引流量>灌注流量，当腔内压力的压差超出了最低警戒线，启动粗调模式，灌注流程档位调至最大，开启泄压阀，并将吸引压力阈值调节到稳定状态下的阀值，达到快速平衡效果，使设备尽快脱离当前状态。如此加快系统响应，减小静差，但该种调节方式超调量会加大，稳定性变差；在本实施例中，将灌注流程档位调整至最低档位或最高档位以加快压力的回调，同时为了避免压力的调整幅度过大，将吸引压力阈值调整至稳定状态下的吸引压力阈值，所述的稳定状态的吸引压力阈值是指主控机记录的腔内压力达到压力控制值区间时的对应的吸引压力阈值。
请参阅图4，当检测到压差超出±3mmHg且处于±8mmHg以内时，启动精调模式，说明腔体内的压力的压差不大，为了维持运行中的灌注需求，保持灌注流量不变，通过控制吸引压力阈值去动态的平衡灌注，并控制体内压力处于“压力控制值”，此状态不需要调整灌注，或者开启泄压阀。因为该两种调节方式会引起数据的较大波动。也容易破坏当前的动态平衡。因此在此阶段时，需要启动系统的精调模式，保持灌注档位维持运转，且泄压阀保持关闭，通过对吸引压力阈值的精调来进行压力调节。此外在灌注吸引过程中，腔体内的管路较多，压力波动较大，且压力检测的频率较快，吸引压力阈值的设定也需要根据数据的变化趋势进行实时调节。本发明的一个实施例中，当压差超出-3mmHg且处于-8mmHg以内，保持灌注流量档位不变，保持泄压阀关闭，灌注维持当前运行，观察上传的数据变化趋势，如果处于上升阶段，增加吸引压力阈值，如果处于下降趋势，减小吸引压力阈值且减小幅度大于上升阶段增加吸引压力阈值的幅度，如此，在数据调整的过程中，整体有降低吸引压力阈值的趋势，以精调的方式达到增压效果。当压差超出3mmHg且处于8mmHg以内，灌注维持当前档位运行，观察上传的数据变化趋势，如果处于上升阶段，增加“吸引压力阈值”，如果处于下降趋势，减小“吸引压力阈值”且减小幅度小于上升阶段增加吸引压力阈值的幅度。这样在数据调整的过程中，整体有增加“吸引压力阈值”的趋势，达到减压效果。判断当前压力检测值状态以及数据变化趋势，调整吸引压力阈值使其呈上升或下降的趋势，降低压力波动大对体腔造成的损伤。
在本发明的一些实施例中，请参阅图3，当检测到压差超出±8mmHg且处于±20mmHg以内时，启动混合调节模式，通过对灌注流量档位、泄压阀与吸引压力阈值的调节结合，将灌注流量精调、泄压阀精调与吸引压力阈值的精调相结合来共同作用于腔内压力，达到增压或减压的效果，具体地，当检测到压差超出8mmHg且处于20mmHg以内时，适度降低灌注流量档位，观察上传的数据变化趋势，如果处于上升阶段，增加吸引压力阈值，如果处于下降趋势，减小“吸引压力阈值”且减小的幅度小于上升阶段增加吸引压力阈值的幅度；这样在数据调整的过程中，整体有增加“吸引压力阈值”的趋势，达到减压效果；当检测到压差超出-8mmHg且处于-20mmHg以内时，灌注流量维持当前运行，阶段性开启泄压阀，观察上传的数据变化趋势，如果处于上升阶段，增加吸引压力阈值，如果处于下降趋势，减小“吸引压力阈值”且减小的幅度大于上升阶段增加吸引压力阈值的幅度；这样在数据调整的过程中，整体有降低“吸引压力阈值”的趋势，达到增压效果；在本实施例中，吸引压力阈值的调节幅度随着腔内压力与压力控制值的压差的增大而增大，如此，通过吸引压力阈值的幅度实现粗调与细调的结合，使得腔内压力快速达到压力控制值，避免体内的压力波动过大带来的组织损伤。
示例性地，对吸引压力阈值对应的负压吸引流量（单位：ml/min）与之间的关系进行统计，分为12类。分别为-5mmhg、-10mmhg、-15mmhg、-20mmhg、-25mmhg、-30mmhg、-35mmhg、-40mmhg、-45mmhg、-50mmhg、-60mmhg、-70mmhg，该值一般用于系统开启的时候，系统默认的初始值，后期会随着动态平衡的过程，更新平衡点的值，从而达到动态平衡的效果。
对腔体内压力与压力控制值的压差Pa（单位：mmhg）进行统计，然后进行分类，腔体内压力存在以下13种状态，1：>20， 2：15<Pa<=20，3：10<Pa<=15，4：8<Pa<=10，5：5<Pa<=8，  6：3<Pa<=5，7：-3<Pa<=3，8：-5<Pa<=-3 ，9：-8<Pa<=-5，10：-10<Pa<=-8，11：-15<Pa<=-10，  12：-20<Pa<=-15  13：-20<Pa。
根据上述统计分类，对新采集的腔体内压力数据与历史数据进行比对，以根据历史数据的变化趋势，通过调整灌注、吸引、泄压阀，快速达到灌注与吸引的动态平衡。
根据腔体内压力与压力控制值的压差Pa（单位：mmhg），本实施例提供如下处理方式：
1.（Pa＞20）：灌注当前档位-4运行，增加吸引压力，根据统计的吸引压力阈值对应的负压吸引流量，加强吸引流量，使吸引流量>灌注流量；并观察上传的数据变化趋势，如果持续上升，将灌注调至最低档位，将吸引压力阈值调至平衡状态的阈值，直至当前腔内压力恢复至“压力控制值”，恢复灌注流量。如果持续下降根据变化需求，调整灌注流量，增加吸引压力阈值从而达到减压效果；
2.（15<Pa<=20）：灌注当前档位-3运行，观察上传的数据变化趋势，如果处于上升阶段，增加“吸引压力阈值+5”，如果处于下降趋势，减小“吸引压力阈值-2”。这样在数据调整的过程中，整体有增加“吸引压力阈值”的趋势；达到减压效果；
3.（10<Pa<=15）：灌注当前档位-2运行，观察上传的数据变化趋势，如果处于上升阶段，增加“吸引压力阈值+5”，如果处于下降趋势，减小“吸引压力阈值-3”。这样在数据调整的过程中，整体有增加“吸引压力阈值”的趋势。达到减压效果；
4.（8<Pa<=10）：灌注当前档位-1运行，观察上传的数据变化趋势，如果处于上升阶段，增加“吸引压力阈值+4”，如果处于下降趋势，减小“吸引压力阈值-1”。这样在数据调整的过程中，整体有增加“吸引压力阈值”的趋势。达到减压效果；
5.（5<Pa<=8）：灌注维持当前运行，观察上传的数据变化趋势，如果处于上升阶段，增加“吸引压力阈值+3”，如果处于下降趋势，减小“吸引压力阈值-1”。这样在数据调整的过程中，整体有增加“吸引压力阈值”的趋势。达到减压效果；
6.（3<Pa<=5）：观察上传的数据变化趋势，如果处于上升阶段，增加“吸引压力阈值+2”，如果处于下降趋势，减小“吸引压力阈值-1”。这样在数据调整的过程中，整体有增加“吸引压力阈值”的趋势。达到减压效果；
7. （-3<Pa<=3）：保持当前状态，并进行计时，记录数据，当达到一定时间时，记录当前吸引压力阈值（也即处于稳定状态对应的吸引压力阈值），并实时更新。当状态破坏时，重新计时，改保存的值可用于动态调节的过程中，快速恢复平衡状态时使用；
8.（-5<Pa<=-3）：灌注维持当前运行，观察上传的数据变化趋势，如果处于上升阶段，增加“吸引压力阈值+1”，如果处于下降趋势，减小“吸引压力阈值-2”。这样在数据调整的过程中，整体有降低“吸引压力阈值”的趋势。达到增压效果；
9.（-8<Pa<=-5）：灌注维持当前运行，观察上传的数据变化趋势，如果处于上升阶段，增加“吸引压力阈值+1”，如果处于下降趋势，减小“吸引压力阈值-3”。这样在数据调整的过程中，整体有降低“吸引压力阈值”的趋势。达到增压效果；
10.（-10<Pa<=-8）：灌注维持当前运行，阶段性开启泄压阀，观察上传的数据变化趋势，如果处于上升阶段，增加“吸引压力阈值+1”，如果处于下降趋势，减小“吸引压力阈值-4”。这样在数据调整的过程中，整体有降低“吸引压力阈值”的趋势。达到增压效果；
11.（-15<Pa<=-10）：灌注维持当前运行，阶段性开启泄压阀，观察上传的数据变化趋势，如果处于上升阶段，增加“吸引压力阈值+3”，如果处于下降趋势，减小“吸引压力阈值-5”。整体有降低“吸引压力阈值”的趋势。达到增压效果；
12.（-20<Pa<=-15）：灌注当前档位+3运行，开启泄压阀，并将“吸引压力阈值”调节到稳定状态下的阀值。观察上传的数据变化趋势，如果处于上升阶段，增加“吸引压力阈值+2”，如果处于下降趋势，减小“吸引压力阈值-5”。这样在数据调整的过程中，整体有降低“吸引压力阈值”的趋势。达到增压效果；
13.（Pa<-20）灌注当前档位+4运行，开启泄压阀，并将吸引压力阈值调节到稳定状态下的阀值，达到快速平衡效果，使设备尽快脱离当前状态。
如上，通过对历史数据进行分析，对腔内的压力值、压力控制值与压力阈值进行数据分析，从而动态调整灌注流量与吸引流量，以达到腔内压力的平衡。
实施例2
请参阅图5，在实施例1的基础上，本实施例的灌注装置包括灌注泵，常温储液袋31、低温储液袋33，进液管、出液管7、温度传感器11与。
鞘管1限定出器械进入通道以便于内窥镜2插设其中，本实施方式提供的鞘管1为三通道鞘管，其中心通道、测压通道与吸引通道，所述中心通道用于内窥镜2插入，所述的吸引通道用于与吸引装置连接。内窥镜2插置在鞘管1内，所述内窥镜2头端的摄像头用于采集腔体内的图像，图像经过图像处理器22处理后输出至显示器以供医生观察腔体内环境情况，所述内窥镜2内形成送液通道，该送液通道用于灌注液的流入。具体地，所述内窥镜2通过内窥镜线束21与图像处理器22连接。
所述灌注泵用于泵送灌注液；所述常温储液袋31用于储存常温灌注液；所述的低温储液袋32用于储存低温灌注液，所述常温储液袋31与低温储液袋33通过进液管与灌注泵连接；所述的灌注泵通过出液管7与内窥镜的送液通道连接。所述的低温储液袋可以为低温生理盐水直接配装在储液袋中，也可以将常温储液袋置于制冷机中，所述的制冷机的温度可以调节，例如通过主控机对制冷机的温度进行温度调控，均可以获得低温储液袋。
温度传感器11设置在内窥镜或鞘管上以检测体腔内的温度；所述主控机根据温度传感器获取的温度信号控制常温灌注液与低温灌注液的混合比例进而来控制灌注液的供给温度；如此，当激光碎石引起的温度过高时，主控机控制常温灌注液与低温灌注液的混合比例，并通过灌注泵将混合后的预定温度的灌注液体送至腔体例如肾盂内病灶部位以带走碎石过程产生的过热热量。此外，灌注液可以冲洗掉术中的出血、结石粉末，保持内窥镜2的视野清晰，还可以撑开腔隙，维持手术所必须的空间。
由于激光碎石过程产生的热量过高，激光的瞬时热量会引起腔体内液体呈沸腾状态，为了避免该过高的温度引起的组织损伤，医生需要调整灌注泵泵的转速加大灌注液的流量以期通过大流量的常温灌注液来带走热量，过大的灌注量会引起腔体内压力过高，因此现有技术需要依赖吸引装置来加快灌注液的循环。然而即便采用高循环的灌注方式，体内瞬时的压力依然处于高位且受限于进液管和出液管的管路尺寸，其流量的增大具有局限性。在实际操作中，25℃的常温灌注液即便加大流量也无法及时将体灌注吸引系统内沸腾的腔内液问降低至合适理想的温度（30-40℃）之间。本实施例提供的温度控制方式可以根据采集温度与理想温度的温度差实时调节灌注液的温度，其一在实现温度控制的目的同时兼具常温灌注液的清洗优势，避免仅有低温灌注液而忽视了常温灌注液的灌注优势；其二，在腔体内温度过高时，可以直接低温灌注液泵入腔体内且可以通过灌注液的流量来迅速带走激光产生的热量，如此，将灌注液在送达送液通道之前进行降温以将冷却后的液体送入腔体内带走热量，例如将5℃以下的液体送入送液通道相较于常温灌注液带走热量的速度显著加快，能够在短时间内到达理想温度，解决了手术历程短降温速度慢的技术问题；其三，随着低温灌注液的泵入，腔体内的温度亦开始回落降低，此时则根据采集温度与理想的温度差来控制低温灌注液和高温灌注液的混合比例，以使得温度控制过程稳定达到理想温度，避免过冷液体进入体内产生冻伤；该控制方法首先精准控制了进液管的灌注液的温度，同时考虑了腔体内实时温度与理想温度差，对实时调节灌注液的温度，实时精确的动态控制病灶部位的温度。
在本发明的一些实施方式中，请参阅图5，所述的灌注吸引系统包括常温储液袋31、低温储液袋33、常温进液管61、低温进液管62、混合管路63、比例控制阀10，常温储液袋31储存常温灌注液；低温储液袋33用于储存低温灌注液；所述常温储液袋31与常温进液管61连接；所述低温储液袋33与低温进液管62连接，所述混合管路63一端与常温进液管61和低温进液管62的出口连通，另一端与灌注泵连接，所述比例控制阀10用于控制常温进液管61与低温进液管62的液体流量；如此，可以通过该灌注吸引系统实现灌注液的温度以及腔体内温度的精确调控。第一种实施方式，医生可以通过比例控制阀10连通常温储液袋31与混合管路63，如此，常温灌注液可以被直接送达腔体内来清洗掉术中的出血、结石粉末等。第二种实施方式，医生可以通过比例控制阀10连通低温储液袋33与混合管路63，如此，当激光碎石引起病灶部位温度过高，例如腔体内液体直接沸腾，则通过比例控制阀将低温灌注液直接送入腔体，迅速带走激光产生的热量。第三种实施方式，随着灌注液的灌入，腔体内温度与理想温度的温度差逐渐缩小，为了避免腔体内液体过冷，医生可以根据腔体内的温度与理想温度的温度差，来调整比例控制阀10以使得常温灌注液与低温灌注液的混合比例来获得具有特定温度的混合灌注液至送液通道，避免灌注液过冷或过热带来的技术问题，实现了温度的精准调控。
可选地，所述的常温进液管61与低温进液管62分别设有比例控制阀10。在本实施例中，所述比例控制阀10为三通阀，所述三通阀将常温进液管61与低温进液管62与混合管路63连接；以上均可以实现上述控温流程。
具体地，所述的三通阀为PID控制阀。
本实施例提供一种灌注吸引系统的温度控制方法，该方法包括如下步骤：
步骤1）预设第一预定温度Tmax和第二预定温度Tmin，即建立标准的理想温度区间；所述的常温储存液具有第一预设温度t1，所述的低温储存液具有第二预设温度t2；具体地，Tmax为40℃，Tmin为30℃，第一预设温度t1为25℃，所述的第二预设温度t2为0-5℃
步骤2）在每进行一次温度采集后，主控机将采集温度T与第一预定温度Tmax和第二预定温度Tmin进行比较，若采集温度T高于第一预定温度Tmax后，控制阀根据采集温度与需要达到的温度之间的温度差，连通低温储液袋33与混合管路63或控制常温进液管61和低温进液管62的混合比例，进而控制混合管路63的输出液体温度；若采集温度T高于第二预定温度Tmin后连通常温储液袋31与混合管路63；
步骤3）若判断采集温度T达到理想温度后30℃-40℃之间，则停止控温流程，若未达标，则进一步根据采集温度T与理想温度的温度差实时调节比例控制阀10的开度，直至调节至理想温度，以获得温度的动态平衡。
现有技术中通过加快灌注流量与吸引流量的循环次数来快速带走腔体内热量的同时避免灌注压力过高带来的伤害。本实施例中提供的低温灌注液可以实现灌注液的小流量的灌注，不会造成压力过高的问题。
可以理解的是，本实施方式提供的灌注吸引系统相较于现有的灌注吸引系统，由于灌注液的温度可控，则显著降低循环次数以及液体流量，避免高流量高压带来的组织损伤，手术过程更温和更精细，温度可控。
所述的温度传感器11装配在内窥镜2或鞘管1，在本实施例中，所述的温度传感器11安装在内窥镜的头端，实时采集腔体内的温度，测温信号可以直接反馈到主控机；也可以传递到电子内窥镜2主机，然后有由电子内窥镜2主机向灌注吸引主机反馈信号。可实时探测人体病灶部位的温度。
在本发明的一个实施例中，请参阅图5，所述比例控制阀10设置在灌注吸引主机内以缩短低温灌注液的行走距离。
在本发明的另一些具体实施例中，请参阅图6，所述灌注吸引系统包括低温灌注泵与高温灌注泵，所述低温灌注泵与低温进液管62连接，所述常温灌注泵与常温进液管连接，常温灌注泵与低温灌注泵的出液口汇合后与出液管连通，如此，可以根据采集温度与理想温度的温度差，实时调节常温灌注泵与低温灌注泵的转速比例，同样可以实现多种灌注方式。具体地，所述的低温灌注泵与高温灌注泵均为蠕动泵，通过灌注吸引主机分别调节2套蠕动泵的转速比例控制混合灌注液的温度与流量。
本实施例进一步提供一种灌注吸引系统的温度控制方法，该方法包括如下步骤：
步骤1）预设第一预定温度Tmax和第二预定温度Tmin，所述的常温储存液具有第一预设温度t1，所述的低温储存液具有第二预设温度t2；
步骤2）在每进行一次温度采集后，将采集温度T与第一预定温度Tmax和第二预定温度Tmin进行比较，采集温度T高于第一预定温度Tmax后或低于第二预定温度Tmin后，主控机分别控制常温灌注泵与低温灌注泵的转速比例来调节常温进液管61和低温进液管62的流量；
3）若判断T达到理想温度后，则停止控温流程，若未达标，则进一步根据温度差实时调节常温灌注泵与低温灌注泵的转速比例，直至调节至理想温度。
在本实施例中，所述的灌注泵、吸引装置的隔膜泵与主控机集成安装，所述灌注吸引主机用于控制灌注与吸引的流量与压力以及控制灌注液的温度，设备更为精简且好操作。为了对管路的液体降温，可以对进液管和出液管通过保温材料包裹。
可选地，所述主控机通过脚踏线缆101与脚踏件100连接，医生手术操作时手部难以操作主控机可以通过脚踏件控制灌注吸引系统。
在本实施例中，如图4-图6所示，本发明提供的系统通过对腔体内压力温度双重监测及时调整灌注的压力、流量以及温度，有效提高手术的安全性，降低手术过程的温度以及压力过高或过低带来的危险。
本发明提供的灌注吸引系统通过对源头的灌注液的温度进行控制来实现对腔体内温度的精准控制，相较于仅依靠灌注流量调节，本实施方式首先降低了对灌注流量的过高要求且温度的控制更为精准且实时，降低术者的经验要求、降低术后的并发症。
尽管已经示出和描述了本发明的实施例，本领域的普通技术人员可以理解：在不脱离本发明的原理和宗旨的情况下可以对这些实施例进行多种变化、修改、替换和变型，本发明的范围由权利要求及其等同物限定。
  在本说明书的描述中，参考术语“一个实施例”、“一些实施例”、“具体实施例”、“可选实施例”、“示例”或“一些示例”等的描述意指结合该实施例或示例描述的具体特征、结构、材料或者特点包含于本发明的至少一个实施例或示例中。在本说明书中，对上述术语的示意性表述不一定指的是相同的实施例或示例。而且，描述的具体特征、结构、材料或者特点可以在任何的一个或多个实施例或示例中以合适的方式结合。

Claims (10)

  1. [根据细则91更正 11.12.2023]
    一种灌注吸引系统的恒压调控方法，其特征在于，所述的灌注吸引系统包括鞘管、内窥镜、灌注装置、吸引装置、主控机、压力传感器；所述鞘管内具有吸引通道，所述内窥镜插置在鞘管内，所述内窥镜内形成送液通道；所述压力传感器配置在内窥镜、鞘管或灌注泵内，所述压力传感器用于检测体腔内的压力，所述灌注装置与送液通道连通以用于将灌注液注入体腔；所述吸引装置包括吸引泵以及与吸引泵连接的吸引容器，所述吸引容器设有泄压阀，所述的吸引容器与吸引通道连通以用于将体腔内液体抽出，所述灌注装置与吸引装置配合以保持腔内处于合适压力；所述主控机与压力传感器、灌注装置以及吸引装置通信连接；
    所述的恒压调控方法包括如下步骤：
    步骤1）预设最高警戒压力值、最低警戒压力值、压力控制值、灌注流量档位；
    步骤2）主控机控制灌注装置将灌注液送入体腔，且能够控制吸引装置将体腔内液体抽出：
    步骤3）压力检测装置对腔体内压力进行采集并输送至主控机，所述主控机根据实时监测到的压力值以及压力值的数据变化趋势，调节灌注与吸引参数，使当前腔内压力平衡在压力控制值，实现灌注与吸引的平衡状态，所述灌注参数包括灌注流量档位，所述的吸引参数包括泄压阀的开启与吸引压力阈值，所述的吸引压力阈值为主控机预设的吸引容器的吸引压力阈值，通过设定吸引压力阈值来控制吸引泵的启停；
    所述主控机恒压调控包括粗调模式，精调模式以及混合调节模式，所述的粗调模式针对腔内压力超出了最高警戒压力值与最低警戒压力值，所述的精调模式针对腔内压力与压力控制值的压差处于第一等级的情形，所述的混合调节模式针对腔内压力与压力控制值的压差处于第二等级的情形，所述的第二等级的压差大于第一等级的压差；
    所述的粗调模式包括如下步骤：调节灌注流量档位以及开启泄压阀的方式来针对压力超过高警戒压力值、最低警戒压力值的情形；
    所述的精调模式包括如下步骤：保持灌注档位维持运转，且泄压阀保持关闭，通过对吸引压力阈值的精调来进行压力调节；
    所述的混合调节模式包括如下步骤：通过对灌注流量档位、泄压阀与吸引压力阈值的调节结合，将灌注流量精调、泄压阀精调与吸引压力阈值的精调相结合来共同作用于腔内压力，达到增压或减压的效果。
  2. [根据细则91更正 11.12.2023]
    根据权利要求1所述的恒压调控方法，其特征在于，当腔内压力与压力控制值的压差超出±20mmHg，启动粗调模式；当压差超出±3mmHg且处于±8mmHg以内时，启动精调模式；当检测到压差超出±8mmHg且处于±20mmHg以内时，启动混合调节模式。
  3. [根据细则91更正 11.12.2023]
    根据权利要求1所述的恒压调控方法，其特征在于，所述的粗调模式包括如下步骤，当体腔内压力值超出了最高警戒线，主控机控制降低灌注流量档位，控制吸引压力阈值使得吸引流量>灌注流量，当腔内压力的压差超出了最低警戒线，将增加灌注流程档位，开启泄压阀，并将吸引压力阈值调节到稳定状态下的阀值，达到快速平衡效果，使腔体内压力尽快脱离极端状态。
  4. [根据细则91更正 11.12.2023]
     根据权利要求2所述的恒压调控方法，其特征在于，当压差超出-3mmHg且处于-8mmHg以内，保持灌注流量档位不变，保持泄压阀关闭，灌注维持当前运行，观察上传的数据变化趋势，如果处于上升阶段，增加吸引压力阈值，如果处于下降趋势，减小吸引压力阈值且减小幅度大于上升阶段增加吸引压力阈值的幅度，如此，在数据调整的过程中，整体有降低吸引压力阈值的趋势，以精调的方式达到增压效果；当压差超出3mmHg且处于8mmHg以内，灌注维持当前档位运行，观察上传的数据变化趋势，如果处于上升阶段，增加“吸引压力阈值”，如果处于下降趋势，减小吸引压力阈值且减小幅度小于上升阶段增加吸引压力阈值的幅度，在数据调整的过程中，整体有增加“吸引压力阈值”的趋势，达到减压效果。
  5. [根据细则91更正 11.12.2023]
     根据权利要求2所述的恒压调控方法，其特征在于，当检测到压差超出8mmHg且处于20mmHg以内时，适当减小灌注流量，观察上传的数据变化趋势，如果处于上升阶段，增加吸引压力阈值，如果处于下降趋势，减小吸引压力阈值且减小的幅度小于上升阶段增加吸引压力阈值的幅度；这样在数据调整的过程中，整体有增加“吸引压力阈值”的趋势，达到减压效果；当检测到压差低于-8mmHg且处于-20mmHg以内时，灌注流量维持当前运行，阶段性开启泄压阀，观察上传的数据变化趋势，如果处于上升阶段，增加吸引压力阈值，如果处于下降趋势，减小“吸引压力阈值”且减小的幅度大于上升阶段增加吸引压力阈值的幅度；这样在数据调整的过程中，整体有减小“吸引压力阈值”的趋势，达到增压效果。
  6. [根据细则91更正 11.12.2023]
     根据权利要求1所述的恒压调控方法，其特征在于，吸引压力阈值的调节幅度随着腔内压力与压力控制值的压差的增大而增大。
  7. [根据细则91更正 11.12.2023]
     一种灌注吸引系统的恒压控温方法，其特征在于，该方法包括权利要求1-6任意一项所述的恒压调控方法以及控温方法；
    所述的灌注装置还包括：
    灌注泵，所述灌注泵用于泵送灌注液；
    常温储液袋，所述常温储液袋用于储存常温灌注液；
    低温储液袋，所述低温储液袋用于储存低温灌注液；
    常温进液管，所述常温储液袋与常温进液管连接；
    低温进液管，所述低温储液袋与低温进液管连接；
    温度传感器，其设置在内窥镜或鞘管上以检测体腔内的温度；
    混合管路，所述混合管路一端与常温进液管和低温进液管的出口连通，另一端与灌注泵连接；
    比例控制阀，所述比例控制阀用于控制常温进液管与低温进液管的液体流量；
    所述主控机根据温度传感器获取的温度信号控制常温灌注液与低温灌注液的混合比例进而来控制灌注液的供给温度；
    所述控温方法包括如下步骤：
    步骤1）预设第一预定温度Tmax和第二预定温度Tmin，所述的常温储存液具有第一预设温度t1，所述的低温储存液具有第二预设温度t2；
    步骤2）在每进行一次温度采集后，将采集温度T与第一预定温度Tmax和第二预定温度Tmin进行比较，采集温度T高于第一预定温度Tmax后或低于第二预定温度Tmin后，控制阀根据采集温度与需要达到的温度之间的温度差，连通常温储液袋与混合管路、连通低温储液袋与混合管路或控制常温进液管和低温进液管的混合比例，进而控制混合管路的输出液体温度；
    若判断T达到理想温度后，则停止控温流程，若未达标，则进一步根据温度差实时调节比例控制阀的开度，直至调节至理想温度。
  8. [根据细则91更正 11.12.2023]
    一种灌注吸引系统的恒压控温方法，其特征在于，该方法包括权利要求1-6任意一项所述的恒压调控方法以及控温方法，所述灌注装置包括：
    低温灌注泵，所述低温灌注泵与低温进液管连接；
    常温灌注泵，所述常温灌注泵与常温进液管连接，常温灌注泵与低温灌注泵的出液口汇合后与出液管连通；
    该方法包括如下步骤：
    步骤1）预设第一预定温度Tmax和第二预定温度Tmin，所述的常温储存液具有第一预设温度t1，所述的低温储存液具有第二预设温度t2；
    步骤2）在每进行一次温度采集后，将采集温度T与第一预定温度Tmax和第二预定温度Tmin进行比较，采集温度T高于第一预定温度Tmax后或低于第二预定温度Tmin后，主控机分别控制常温灌注泵与低温灌注泵的转速比例来调节常温进液管和低温进液管的流量；
    步骤3）若判断T达到理想温度后，则停止控温流程，若未达标，则进一步根据温度差实时调节常温灌注泵与低温灌注泵的转速比例，直至调节至理想温度。
  9. [根据细则91更正 11.12.2023]
    一种灌注吸引器，其特征在于，所述灌注吸引器包括吸引装置与灌注装置，所述的灌注装置包括灌注泵，所述灌注泵用于泵送灌注液；
    常温储液袋，所述常温储液袋用于储存常温灌注液；
    低温储液袋，所述低温储液袋用于储存低温灌注液；
    常温进液管，所述常温储液袋与常温进液管连接；
    低温进液管，所述低温储液袋与低温进液管连接；
    所述的吸引容器包括吸引泵、第一负压吸引管、吸引容器和第二负压吸引管，所述第一负压吸引管一端与吸引泵连接，另一端与吸引容器连接，所述的第二负压吸引管一端与吸引容器连接，另一端与鞘管连接；
    主控机，所述主控机与灌注装置以及吸引装置通信连接。
  10. [根据细则91更正 11.12.2023]
    根据权利要求9所述的灌注吸引器，其特征在于，所述的灌注泵、隔膜泵、主控机集成安装。
PCT/CN2023/100677 2023-06-16 2023-06-16 一种灌注吸引系统的恒压及控温方法 Ceased WO2024254845A1 (zh)

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