CN111839713B - Multi-modal tumor ablation probe system and control method thereof - Google Patents
Multi-modal tumor ablation probe system and control method thereof Download PDFInfo
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Abstract
The application relates to the field of medical instruments and discloses a multi-modal tumor ablation probe system and a control method thereof. A probe system, comprising: the device comprises a liquid nitrogen storage tank, a gas-liquid separation device, a valve block, a probe, an exhaust electromagnetic valve and a control device; the inlet of the gas-liquid separation device is connected with the liquid nitrogen storage tank to input liquid nitrogen; a liquid outlet of the gas-liquid separation device is connected with the valve block, and liquid nitrogen is input into the probe through the valve block so as to refrigerate the probe; the exhaust port of the gas-liquid separation device is connected to an exhaust electromagnetic valve; the valve block is internally provided with a temperature sensor and a pressure sensor which are used for measuring the temperature value and the pressure value of the liquid nitrogen flowing through the valve block; the control device is used for controlling the opening and closing proportion of the exhaust electromagnetic valve according to the temperature value output by the temperature sensor and the pressure value output by the pressure sensor.
Description
Technical Field
The application relates to the field of medical equipment, in particular to a tumor ablation probe technology.
Background
The incidence of malignant tumors is increasing year by year, the threat to human health is increasing, the traditional treatment methods such as surgical operation, radiotherapy, chemotherapy and the like are becoming mature, but all the traditional treatment methods inevitably cause different degrees of damage to the normal functions of the organism, and the success rate of treatment still needs to be improved. With the development of scientific technology, especially the improvement of medical imaging technology such as magnetic resonance imaging, ultrasonic imaging and the like, minimally invasive surgery such as cryotherapy, heat ablation therapy and the like of tumors has been developed and is becoming more and more popular, but the minimally invasive surgery still has respective defects.
The multi-modal thermal physical treatment of the tumor can overcome the defects of single cold and single heat therapy, improve the cure rate of the tumor, and simultaneously protect normal tissues from being damaged, thereby becoming a hot point direction for the research of the thermal physical treatment of the tumor. By accurately controlling and adjusting the local thermophysical action of the malignant tumor, the multi-modal thermophysical treatment can effectively treat the in-situ tumor, relieve the immunosuppression of the malignant tumor to the organism, and induce and enhance the anti-tumor immune response of the organism, thereby effectively inhibiting the distal metastasis.
The invention patent CN201610453842.1 of China successfully develops a small digital cold and hot alternating therapeutic apparatus which can realize the freezing process control of multi-modal tumor ablation and the generation and control of heating energy. But the invention is suitable for realizing the freezing process of low-pressure liquid nitrogen in a large-size probe.
With the further development of minimally invasive surgery, there is a great need for the development of a multi-modal tumor ablation probe of micro size (< =2 mm).
The micro-size probe in the current market or proposed by existing research uses high-pressure liquid nitrogen, the high-pressure liquid nitrogen freezing probe has long refrigeration time, the high pressure reduces the safety factor, increases the complexity of the system, and is difficult to meet the freezing requirements of multi-mode ablation accurate control and rapid precooling.
The size of the current low-pressure liquid nitrogen freezing probe is generally larger than 3mm, and the reason is that after liquid nitrogen is gasified in the probe to form nitrogen gas, the local pressure rises sharply, the flow area of the microscale probe is small, the flow resistance is large, so that the gas cannot be discharged in time, and the phenomenon of pipeline blockage, namely the air resistance problem, is easily formed.
Disclosure of Invention
The application aims to provide a multi-modal tumor ablation probe system and a control method thereof, and the first problem to be solved is that: for the freezing system of effective phase change heat transfer in the low-pressure liquid nitrogen micro-channel, the air resistance problem is avoided, and the environment of an operating room is not influenced by the aerial fog formed by the liquid nitrogen.
The second problem to be solved is: how to realize multi-modal ablation control with the heating area and the freezing area completely coincident.
The third problem to be solved is: finding out the structural parameters of the micro-scale multi-mode probe suitable for low-pressure liquid nitrogen refrigeration.
The application discloses probe system includes: the device comprises a liquid nitrogen storage tank, a gas-liquid separation device, a valve block, a probe, an exhaust electromagnetic valve and a control device;
the inlet of the gas-liquid separation device is connected with the liquid nitrogen storage tank to input liquid nitrogen; a liquid outlet of the gas-liquid separation device is connected with the valve block, and liquid nitrogen is input into the probe through the valve block so as to refrigerate the probe; an exhaust port of the gas-liquid separation device is connected to the exhaust electromagnetic valve;
the valve block is internally provided with a first temperature sensor and a first pressure sensor which are used for measuring the temperature value and the pressure value of liquid nitrogen flowing through the valve block;
the control device is used for controlling the opening and closing proportion of the exhaust electromagnetic valve according to the temperature value output by the first temperature sensor and the pressure value output by the pressure sensor.
In a preferred example, the exhaust solenoid valve is opened and closed periodically, and the opening and closing proportion is a proportion of the opening time length and the closing time length of the exhaust solenoid valve.
In a preferred embodiment, the device further comprises a waste liquid treatment device and a loop electromagnetic valve;
the outlet of the probe is connected to the loop electromagnetic valve, waste liquid is input to the waste liquid treatment device through the loop electromagnetic valve, the outlet of the exhaust electromagnetic valve is also connected to the waste liquid treatment device, and the waste liquid treatment device is used for treating the input waste liquid into normal-temperature gas and then discharging the gas into the air.
In a preferred embodiment, the waste liquid treatment device comprises a collection box, a heater, a second temperature sensor and a fan; the waste liquid discharged by the exhaust electromagnetic valve and the loop electromagnetic valve is fully mixed in the collecting box, and then the on-off state of the heater is controlled through the temperature information monitored by the second temperature sensor, so that the waste liquid is heated to normal temperature gas; the fan works to form negative pressure, so that the heated gas is discharged into the air.
The application also discloses a multi-modal tumor ablation probe system comprising a probe system as described in the foregoing and a radio frequency generating device;
the radio frequency generating device is used for providing radio frequency current to the probe so that the probe is heated;
the control device is also used for controlling the radio frequency generation device.
In a preferred embodiment, the outer diameter of the probe is less than or equal to 2mm; the ratio of the inlet air area to the outlet air area is between 0.1 and 0.6; the inner diameter of the air inlet pipe is more than or equal to 0.5mm; the distance between the mouth of the air inlet pipe and the needle point is less than or equal to 6mm.
In a preferred embodiment, the probe comprises a treatment section for tumor freezing and heating, an insulation section for thermal insulation and electrical insulation of normal tissues, and a connection section for transmission of temperature signals, radio frequency signals and liquid nitrogen;
during freezing, liquid nitrogen flows into the tube cavity of the treatment section through the air inlet pipe to perform phase change heat exchange, and then flows out of the probe through the air return channel; during heating, the probe inputs radio frequency current through a radio frequency signal wire, and the outside of the needle rod except the treatment section is wrapped with an electric insulation layer so as to ensure that radio frequency energy is only output from the treatment section;
the treatment section comprises a temperature sensor for feeding back temperature information in real time during the treatment process.
In a preferred example, the pressure of liquid nitrogen used for freezing the probe is less than or equal to 1MPa.
In a preferred embodiment, the freezing control comprises the following steps:
acquiring the liquid nitrogen pressure P and the temperature T1 of an input probe in real time through a pressure sensor and a temperature sensor in the valve block;
calculating the liquid nitrogen-gas liquid ratio alpha (P, T1) in real time according to the liquid nitrogen phase change heat exchange principle;
outputting an opening and closing proportion control function f (t) of the exhaust electromagnetic valve to ensure that the liquid nitrogen gas-liquid ratio alpha of the input probe is greater than or equal to 0.9;
calculating liquid nitrogen flow Q (P, alpha) in real time according to the liquid nitrogen pressure P and the liquid nitrogen-liquid ratio alpha;
and outputting an opening and closing proportion control function g (t) of the loop electromagnetic valve to realize the flow control of the liquid nitrogen flowing through the probe, thereby realizing different freezing rates and freezing ranges.
In a preferred embodiment, the heating comprises the following steps:
determining a target heating range d _ a according to the freezing range;
according to a precooled radio frequency heating heat transfer principle, establishing a relation function d (T2, T) of a radio frequency heating temperature boundary d and a probe central temperature T2, and determining a target heating temperature T2_ a according to a target heating range d _ a;
collecting parameters such as tissue impedance (Z), heating power (p), probe temperature measurement temperature (T2) and the like in real time;
and establishing a radio frequency power and temperature accurate control function T2 (Z, p, T) by combining a multi-modal ablation heating model, adjusting the input heating power p (Z, T2_ a, T) according to the target heating temperature T2_ a, and realizing real-time accurate control of a heating temperature field, thereby realizing multi-modal tumor ablation with a heating area and a freezing area completely superposed.
In the embodiment of the application, carry out gas-liquid separation to the liquid nitrogen from liquid nitrogen storage jar output through gas-liquid separation device, set up exhaust solenoid valve at gas-liquid separation device's gas vent, according to the temperature of the liquid nitrogen that will flow into the probe and the proportion that opens and shuts of pressure control exhaust solenoid valve, thereby it does not have gas in the liquid nitrogen that has guaranteed to flow into the probe on the one hand, the possibility of air lock has been reduced, on the other hand can not make the liquid nitrogen spill over from gas-liquid separator's gas vent, the liquid nitrogen formation aerial fog that has prevented to spill over from the gas vent influences the operating room environment. In the freezing process, the control system adjusts the liquid nitrogen-gas ratio and the flow rate of liquid nitrogen through the exhaust electromagnetic valve at the exhaust port of the gas-liquid separation device and the opening and closing proportion of the main control electromagnetic valve, so that the cooling rate and the freezing range in the freezing process can be accurately controlled, and in one embodiment, a single multi-mode tumor ablation probe can form an ice ball with the depth of more than 4cm in the biomimetic colloid.
Furthermore, a probe structure design suitable for micro-size (less than or equal to 2 mm) and based on low-pressure liquid nitrogen freezing (less than or equal to 1 MPa) is provided, and effective phase change heat exchange of the low-pressure liquid nitrogen in the micro-channel is realized.
In addition, the heating area and the freezing area can be completely overlapped through a freezing control algorithm based on the regulation of liquid nitrogen flow and gas-liquid ratio and a heating control algorithm based on the regulation of radio frequency power and temperature, and the treatment effect is ensured.
In addition, the low-pressure liquid nitrogen refrigeration provided by the application has the advantages of being safer, less in nitrogen consumption, low in complexity, controllable in treatment process and the like compared with the existing high-pressure nitrogen refrigeration.
The present specification describes a number of technical features distributed throughout the various technical aspects, and if all possible combinations of technical features (i.e. technical aspects) of the present specification are listed, the description is made excessively long. In order to avoid this problem, the respective technical features disclosed in the above-mentioned summary of the invention of the present application, the respective technical features disclosed in the following embodiments and examples, and the respective technical features disclosed in the drawings may be freely combined with each other to constitute various new technical solutions (these technical solutions should all be considered as having been described in the present specification), unless such a combination of the technical features is technically impossible. For example, in one example, the feature a + B + C is disclosed, in another example, the feature a + B + D + E is disclosed, and the features C and D are equivalent technical means for the same purpose, and technically only one feature is used, but not simultaneously employed, and the feature E can be technically combined with the feature C, then the solution of a + B + C + D should not be considered as being described because the technology is not feasible, and the solution of a + B + C + E should be considered as being described.
Drawings
FIG. 1 is a schematic structural diagram of a probe system according to a first embodiment of the present application;
FIG. 2 is a schematic structural diagram of a multi-modal tumor ablation probe system according to a second embodiment of the present application;
FIG. 3 is a schematic structural diagram of a multi-modal tumor ablation probe system according to a preferred embodiment of the present application;
FIG. 4 is a schematic view of a multi-modal ablation zone configuration in accordance with a preferred embodiment of the present application;
FIG. 5 is a schematic diagram of a thermal isolation region structure according to a preferred embodiment of the present application;
FIG. 6 is a schematic diagram of a multi-modal energy transmission channel configuration in accordance with a preferred embodiment of the present application;
FIG. 7 is a schematic diagram of a probe control system according to a preferred embodiment of the present application.
The system comprises a probe 1, a probe 2, a probe control system 3, a liquid nitrogen storage tank 4, a multi-modal tumor ablation control system 11, a multi-modal ablation area 12, a thermal isolation area 13, a multi-modal energy transmission channel 14, a liquid nitrogen transmission channel 15, a nitrogen backflow channel 16, a data transmission line 16, a needle tube 111, a heat exchange enhancement device 112, a liquid nitrogen outlet 113, a temperature sensor 114, an outer insulation layer 121, a low-temperature thermal isolation area 122, a channel outer layer 131, a thermal insulation material 132, a liquid nitrogen low-temperature switch electromagnetic valve 21, a liquid nitrogen split outlet 22, a gas-liquid separator control valve 23, an exhaust port 24, a gas-liquid separator controller 25, a gas-liquid separator 26, a gas-liquid separator control line 27, a valve block 213, an exhaust electromagnet 214, a loop electromagnetic valve 215-215, a waste liquid treatment device 216, a control device 217 and a radio frequency generator 218.
The size and thickness of each component shown in the drawings are arbitrarily illustrated, and the size and thickness of each component are not limited in the present application. The thickness of the components may be exaggerated where appropriate in the figures to improve clarity.
Detailed Description
In the following description, numerous technical details are set forth in order to provide a better understanding of the present application. However, it will be understood by those skilled in the art that the technical solutions claimed in the present application may be implemented without these technical details and with various changes and modifications based on the following embodiments.
To make the objects, technical solutions and advantages of the present application more clear, embodiments of the present application will be described in further detail below with reference to the accompanying drawings.
A first embodiment of the present application relates to a probe system, the structure of which is shown in fig. 1. The system comprises a liquid nitrogen storage tank 3, a gas-liquid separator 26, a valve block 213, a probe 1, an exhaust solenoid valve 214, a control device 217, a waste liquid treatment device 216 and a loop solenoid valve 215. Wherein the waste liquid treatment device and the loop solenoid valve are optional.
An inlet of the gas-liquid separator 26 is connected to the liquid nitrogen storage tank 3 to input liquid nitrogen. The liquid outlet of the gas-liquid separator 26 is connected to the valve block 213, and liquid nitrogen is supplied to the probe 1 through the valve block 213 to cool the probe 1. The exhaust port of the gas-liquid separator 26 is connected to an exhaust solenoid valve 214.
A first temperature sensor and a pressure sensor (not shown) are provided in the valve block 213 for measuring a temperature value and a pressure value of the liquid nitrogen flowing through the valve block 213.
The outlet of the probe 1 is connected to a circuit solenoid valve 215, waste liquid is input to a waste liquid treatment device 216 through the circuit solenoid valve 215, the outlet of the exhaust solenoid valve 214 is also connected to the waste liquid treatment device 216, and the waste liquid treatment device 216 discharges the input waste liquid into air after treating the waste liquid into normal temperature gas.
The control device 217 is used for controlling the opening and closing proportion of the exhaust solenoid valve 214 according to the temperature value output by the first temperature sensor and the pressure value output by the pressure sensor. In one embodiment, initially, the pipeline is in a pre-cooling state, and the exhaust solenoid valve is in a normally open state for exhausting. When the temperature measured by the first temperature sensor is reduced to a certain temperature (-120 ℃), precooling is completed, the control strategy is changed into duty ratio control, the period is 1s, the duty ratio is related to the pressure, the duty ratio is smaller when the pressure is larger, the duty ratio is larger when the pressure is smaller, and the following equation can be used for describing the precooling control method:
there are various ways of controlling the opening/closing ratio of the exhaust solenoid valve 214. In one embodiment, the exhaust solenoid valve 214 has only two states of fully open and fully closed, and the exhaust solenoid valve 214 is opened and closed periodically, and the opening and closing ratio is the ratio of the opening time length and the closing time length of the exhaust solenoid valve 214, or the opening and closing ratio may be a duty ratio. By controlling the duty cycle, the function of the exhaust solenoid 214 can be achieved using a low cost, common solenoid. In another embodiment, the exhaust solenoid valve 214 may be proportionally opened (i.e., a proportional valve), where the opening-closing ratio may be the ratio at which the exhaust solenoid valve 214 is opened. Proportional valves are generally more complex and expensive than solenoid valves that can only be fully opened and closed, and no proportional valve for liquid nitrogen is currently found on the market.
Optionally, in one embodiment, the waste liquid treatment device 216 includes a collection cartridge, a heater, a second temperature sensor, and a fan. The waste liquid discharged through the exhaust solenoid valve 214 and the return solenoid valve 215 is first mixed sufficiently in the collection box, and then the on-off state of the heater is controlled by the temperature information monitored by the second temperature sensor, so that the waste liquid is heated to a normal temperature gas. The fan works to form negative pressure, so that the heated gas is discharged into the air.
A second embodiment of the present application relates to a multi-modal tumor ablation probe system, the structure of which is shown in fig. 2, which adds a heating function to the probe system of the first embodiment. In particular, the multi-modal tumor ablation probe system comprises, in addition to the various modules in the probe system of the first embodiment, a radio frequency generating means 218 for supplying a radio frequency current to the probe 1 such that the probe 1 heats up.
The control means 217 are also used to control the radio frequency generating means 218.
In one embodiment, the probe 1 comprises a treatment section for tumor freezing and heating, an insulation section for thermal and electrical insulation of normal tissue, and a connection section for transmission of temperature signals, radio frequency signals and liquid nitrogen. During freezing, liquid nitrogen flows into the tube cavity of the treatment section through the air inlet pipe to perform phase change heat exchange, and then flows out of the probe 1 through the air return channel. When heating, the probe 1 inputs radio frequency current through the radio frequency signal line, and the outside of the needle rod except for the treatment section is wrapped with an electric insulation layer to ensure that the radio frequency energy is only output from the treatment section. The treatment section comprises a temperature sensor for feeding back temperature information in real time during the treatment process.
In one embodiment, the structure of the probe 1 is optimized, and the outer diameter of the probe 1 is less than or equal to 2mm. The ratio of the inlet to outlet areas is between 0.1 and 0.6, with a preferred value of 0.4. The inner diameter of the air inlet pipe is more than or equal to 0.5mm. The distance between the mouth of the air inlet pipe and the needle point is less than or equal to 6mm (the optimal value is 5 mm). The probe structure is suitable for probes with micro sizes (less than or equal to 2 mm) and based on low-pressure liquid nitrogen freezing (less than or equal to 1 MPa), and realizes effective phase change heat exchange of low-pressure liquid nitrogen in the micro-channel. During freezing, liquid nitrogen flows into the tube cavity of the treatment section through the air inlet pipe to perform phase change heat exchange, and then flows out of the probe 1 through the air return channel; during heating, radio frequency signals are transmitted to the probe 1 through radio frequency signal wires, and the outside of the needle rod except for the treatment section is wrapped with an electric insulation layer so as to ensure that radio frequency energy is only output from the treatment section. The needle point of the probe 1 is designed with a temperature sensor for feeding back temperature information in real time during the treatment process.
A third embodiment of the present application relates to a method for controlling a multi-modal tumor ablation probe system, which is used for the multi-modal tumor ablation probe system of the second embodiment, and comprises a control during freezing and a control during heating. Wherein,
the method comprises the following steps in freezing control:
the liquid nitrogen pressure P and temperature T1 input to the probe 1 are collected in real time by the pressure sensor and the first temperature sensor in the valve block 213.
And calculating the liquid-gas ratio alpha (P, T1) of the liquid nitrogen in real time according to the liquid nitrogen phase change heat exchange principle. For example, the liquid-gas ratio of liquid nitrogen and the temperature T can be simplified into a two-stage function, when T1 is at a higher temperature, the liquid-gas ratio is 0, when T1 is reduced to a certain temperature, the liquid-gas ratio and T1 can be expressed by a linear equation, the coefficient is related to the pressure, and different coefficients are selected according to different pressures. It can therefore be expressed by the following equation:
and outputting an opening and closing ratio control function f (t) of the exhaust solenoid valve 214 to ensure that the liquid nitrogen liquid-gas ratio alpha of the input probe 1 is greater than or equal to 0.9. For example, the exhaust solenoid valve is opened all the time, the liquid-gas ratio of liquid nitrogen can be increased, when the liquid-gas ratio is less than 0.9, the solenoid valve is opened all the time, when the liquid-gas ratio is more than 0.9, the duty ratio (D) control is adopted, and the duty ratio is related to the pressure. As a result of research, the duty cycle can be expressed by the following equation:
calculating liquid nitrogen flow Q (P, alpha) in real time according to the liquid nitrogen pressure P and the liquid nitrogen-liquid ratio alpha;
the opening and closing proportion of the electromagnetic valve 215 of the output loop controls the function g (t) to realize the flow control of the liquid nitrogen flowing through the probe 1, thereby realizing different freezing rates and freezing ranges. For example, different freezing ranges are mainly related to the total amount of liquid nitrogen flowing in the same time t, and if the total amount of liquid nitrogen required for refrigeration is Q0, the required average flow rate is Q0/t, so the open-and-proportional control function can be simply expressed by the following equation:
the heating process includes the following steps:
from the freezing range, a target heating range d _ a is determined.
According to the precooled radio frequency heating heat transfer principle, establishing a relation function d (T2, T) of a radio frequency heating temperature boundary d and the probe central temperature T2, and determining a target heating temperature T2_ a according to a target heating range d _ a. For example, the central temperature T2 and the heating time T can be simplified to be an exponential function, and coefficients of the exponential function are related to the target heating range, and different coefficients are selected according to different target heating ranges.
It can therefore be expressed by the following equation:
T2 d_a ＝a-b×c t
and collecting parameters such as tissue impedance (Z), heating power (p), probe temperature measurement temperature (T2) and the like in real time.
And establishing a radio frequency power and temperature accurate control function T2 (Z, p, T) by combining a multi-modal ablation heating model, adjusting the input heating power p (Z, T2_ a, T) according to the target heating temperature T2_ a, and realizing real-time accurate control of a heating temperature field, thereby realizing multi-modal tumor ablation with a heating area and a freezing area completely superposed. For example, the relationship between the rf power and the heating time can be well expressed as an exponential function, and the coefficients of the exponential function are related to the impedance and the target core temperature, with different coefficients being selected based on different impedances and core temperatures. It can therefore be expressed by the following equation:
p Z,T_a ＝a-b×c t
in order to better understand the technical solution of the present application, the following description is given with reference to a specific example, in which the listed details are mainly for the sake of understanding and are not intended to limit the scope of the present application.
As shown in fig. 3, the multi-modal tumor ablation probe system provided by the present embodiment includes a multi-modal tumor ablation probe 1, a probe control system 2, a liquid nitrogen storage tank 3, and a multi-modal tumor ablation control system 4. Wherein, the liquid nitrogen outlet of the liquid nitrogen storage tank 3 is connected with the inlet of the probe control system 2 through a pipeline, the outlet of the probe control system 2 is connected with the multi-modal tumor ablation probe 1, and the multi-modal tumor ablation control system 4 is connected with the probe control system 2 through a signal line.
In fig. 3, the multi-modal tumor ablation probe 1 is provided with a multi-modal ablation zone 11, a thermal isolation zone 12 and a multi-modal energy transmission channel 13 in sequence from the right along the length thereof. Inside the multi-modal tumor ablation probe 1, along its length direction, there are disposed a liquid nitrogen transmission channel 14, a nitrogen gas reflux channel 15, and a data transmission line 16. A plurality of pressure sensors (not shown in fig. 3) are provided on the liquid nitrogen delivery passage 14 for collecting pressure information of the liquid nitrogen.
In order to meet the development requirement of minimally invasive surgery, in the embodiment, the outer diameter of the multi-modal tumor ablation probe 1 is less than or equal to 2mm.
The multi-modal ablation zone 11 is used for performing targeted ablation on tumor tissues, the thermal isolation zone 12 is used for protecting normal tissues in the multi-modal ablation process, and the multi-modal energy transmission channel 13 is used for transmitting temperature signals of liquid nitrogen transmission, heat energy transmission and collection.
The liquid nitrogen storage tank 3 is used for providing a cold source during the freezing process, the cold source substance is liquid nitrogen, and in order to improve the safety of the freezing process, the pressure of the liquid nitrogen is less than or equal to 1Mpa.
As shown in fig. 4, the multi-modal ablation zone 11 is the area directly facing the tumor where ablation is performed, and includes a needle 111, a liquid nitrogen outlet 113, and a heating device (not shown in fig. 4).
During the freezing process, the liquid nitrogen moves to the liquid nitrogen outlet 113 along the liquid nitrogen transmission channel 14, the liquid nitrogen performs phase change heat exchange and is converted into gaseous nitrogen, and at the moment, the temperature of the nitrogen is raised and moves towards the probe control system 2 along the nitrogen backflow channel 15. The temperature of the multi-modal ablation zone 11 rapidly drops with the phase change heat exchange of the liquid nitrogen and the freezing energy is transmitted to the tumor tissue through the needle tube 111. The direction indicated by the arrow is the flow direction of the liquid nitrogen and nitrogen.
Meanwhile, in order to heat the multi-modal ablation zone 11 so that the heating region coincides with the freezing region, a heating device is provided inside the needle tube 111, the heating device is connected to the multi-modal tumor ablation control system 4 through a data transmission line 16, and the heating process is controlled by the multi-modal tumor ablation control system 4. The heating device adopts a radio frequency electrode, and realizes a heating process by transmitting radio frequency energy. Heating energy is delivered to the tumor tissue through the needle 111.
The multi-modal tumor ablation control system 4 can output a freeze signal to the probe control system 2 or a heat signal. In order to realize that the multi-modal tumor ablation probe system can carry out multi-modal therapy or carry out single cryotherapy or single heating therapy, different signals are output by the multi-modal tumor ablation control system 4 so as to control the therapy mode.
It should be noted that, in the present embodiment, the needle tube 111 may be a single-stage needle tube or a multi-stage needle tube, and a plurality of needle tubes 111 may be arranged in an umbrella shape during the heat treatment.
In order to improve the heat exchange efficiency, a heat exchange enhancing means 112 is provided in the multi-modal ablation zone 11 and fixed to the inner wall of the needle tube 111.
In order to control the freezing process and the heating process more precisely, a temperature sensor 114 is further provided inside the multi-modal ablation zone 11 for collecting temperature information during the treatment process in real time and correcting the output of the freezing control and the heating control. The signals from the temperature sensor 114 are transmitted via the data transmission line 16 to the probe control system 2 and the multi-modal tumor ablation control system 4.
As shown in fig. 5, the thermal isolation region 12 includes an outer insulating layer 121 and a low-temperature thermal isolation region 122. The thermal isolation region 122 functions to prevent damage to normal tissue during multi-modal ablation, primarily to prevent damage to normal tissue from hypothermia. The outer insulating layer 121 is wrapped outside the liquid nitrogen transmission channel 14, the nitrogen gas return channel 15 and the data transmission line 16, and a low-temperature thermal isolation region 122 is formed between the outer insulating layer 121 and the nitrogen gas return channel 15. The low temperature thermal isolation region 122 may be cold isolated using vacuum techniques or using an insulating material. The outer insulating layer 121 provides thermal and electrical isolation. During the freezing process, certain cold quantity can be generated when the liquid nitrogen passes through the liquid nitrogen transmission channel 14 and when the nitrogen after heat exchange passes through the nitrogen backflow channel 15, so that damage to normal tissues can be generated, and the damage can be prevented after the low-temperature thermal isolation region 122 is arranged. The outer insulating layer 121 prevents high frequency current from damaging normal tissue during heating. The direction indicated by the arrow is the flow direction of the liquid nitrogen and nitrogen gas.
As shown in fig. 3 and 6, the multi-modal energy transmission channel 13 is disposed on the multi-modal tumor ablation probe 1 on a side close to the probe control system 2, and includes a channel outer layer 131 and an insulating material 132. Inside the multi-mode energy transmission channel 13, the liquid nitrogen transmission channel 14, the nitrogen backflow channel 15 and the data transmission line 16 pass through the multi-mode energy transmission channel, and the channel outer layer 131 wraps the liquid nitrogen transmission channel 14, the nitrogen backflow channel 15 and the data transmission line 16 and fills gaps with the heat insulation material 132. The insulating material 132 can reduce heat exchange loss of the liquid nitrogen during the transmission process. The direction indicated by the arrow is the flow direction of the liquid nitrogen and nitrogen.
As shown in fig. 7, the probe control system 2 includes a gas-liquid separation device including a gas-liquid separator 26, an exhaust port 24 provided on an outlet side of the gas-liquid separator 26, a gas-liquid separator control valve 23 provided on the exhaust port 24, a liquid nitrogen tapping port 22 provided at an outlet of the gas-liquid separator 26, a low-temperature on-off solenoid valve 21 provided at the liquid nitrogen tapping port 22, and a gas-liquid separator controller 25 connected to the gas-liquid separator control valve 23 and the low-temperature on-off solenoid valve 21 via a gas-liquid separator control line 27, respectively. The inlet of the gas-liquid separator 26 is communicated with the liquid nitrogen storage tank 3 through a pipeline; the liquid nitrogen shunt outlet 22 at least has one outlet channel, and one outlet channel is communicated with the liquid nitrogen transmission channel 14 of the multi-modal tumor ablation probe 1 through a low-temperature switch electromagnetic valve 21. It is understood that a plurality of multi-modal tumor ablation probes 1 can be connected by providing the liquid nitrogen outflow split port 22. In this embodiment, only one multi-modal tumor ablation probe 1 is employed. The direction indicated by the arrow is the flow direction of the liquid nitrogen and nitrogen.
The gas-liquid separator controller 25 controls the operation of the gas-liquid separator control valve 23 by using a phase-change heat exchange algorithm in the treatment process, thereby controlling the working state of the gas-liquid separator 26, adjusting the phase-change heat exchange process of the liquid nitrogen, and enabling the liquid nitrogen to perform sufficient phase-change heat exchange to achieve the purpose of rapid freezing. Whether liquid nitrogen transmission is carried out or not is realized by controlling the opening and closing of the low-temperature switch electromagnetic valve 21.
The multi-modal tumor ablation probe system in this embodiment works as follows:
when the multi-mode tumor ablation probe system works, the multi-mode ablation region 11 of the multi-mode tumor ablation probe 1 is punctured to the position for treating the tumor through the skin according to the shape and the position of the corresponding tumor, and then the treatment is started.
In the freezing process, the multi-modal tumor ablation control system 4 sends out a freezing signal, and the gas-liquid separator controller 25 of the probe control system 2 controls to open the low-temperature switch electromagnetic valve 21 which is connected with the multi-modal tumor ablation probe 1 at present and open the liquid nitrogen transmission channel 14. And redundant nitrogen generated by pipeline transmission heat exchange in the gas-liquid separator 25 can be separated out through the exhaust port 24, so that precooling of liquid nitrogen is realized. Meanwhile, the gas-liquid separator controller 25 outputs the switching function f (T, P) of the gas-liquid separator control valve 23 through a phase-change heat exchange algorithm (where T is the operating time of the gas-liquid separator control valve 23), controls the operation of the gas-liquid separator control valve 23, and controls the operating state of the gas-liquid separator 26, so that the low-pressure liquid nitrogen passes through the liquid nitrogen split-flow outlet 22 and the low-temperature switching solenoid valve 21 from the outlet of the gas-liquid separator 26 in sequence, passes through the liquid nitrogen transmission channel 14 of the multi-modal energy transmission channel 13 of the multi-modal tumor ablation probe 1, passes through the thermal isolation region 12, and reaches the liquid nitrogen outlet 113 of the multi-modal ablation region 11, and then the liquid nitrogen performs sufficient phase-change heat exchange, thereby achieving the purpose of rapid freezing. The gas-liquid separator controller 25 establishes a phase change heat exchange algorithm for controlling the freezing process by combining a liquid nitrogen phase change heat exchange freezing model according to the temperature signal and the liquid nitrogen pressure signal transmitted back by the temperature sensor 122 and the pressure sensor, outputs a switch control function f (T, T, P) of the gas-liquid separator control valve 23, and adjusts the flowing state of low-pressure liquid nitrogen in a liquid nitrogen transmission passage by controlling the work of the gas-liquid separator control valve 23, so that the liquid nitrogen can perform sufficient phase change heat exchange in the multi-mode melting area 11, and the freezing process can be accurately controlled.
In order to fully and fully exchange heat for the liquid nitrogen entering the inside of the needle tube 111, a heat exchange enhancement device 112 is arranged on the inner wall of the needle tube 111. High-temperature nitrogen formed after heat exchange of the liquid nitrogen is timely discharged through the nitrogen backflow channel 15, so that the air pressure inside the multi-modal tumor ablation needle tube 1 is reduced, and the aim of continuous refrigeration is fulfilled.
In the heating process, the multi-modal tumor ablation control system 4 sends out a heating signal, and the probe control system 2 controls the liquid nitrogen transmission passage to stop working. The multi-modal tumor ablation control system 4 establishes heating energy and a temperature control function g (T, Z, P, T) (wherein T is heating time) according to information such as heating power (P), ablated tissue impedance (Z), temperature (T) acquired by the temperature sensor 122 and the like, in combination with a multi-modal ablation heating model, accurately controls the input of the heating energy, and realizes real-time accurate control of a heating temperature field, thereby realizing multi-modal tumor ablation in which a heating region and a freezing region are completely overlapped.
During the freezing and heating processes, the temperature sensor 114 can acquire the temperature data of the ablation target area in the ablation process in real time, and return the temperature data to the multi-modal tumor ablation control system 4 for control feedback and display.
In this embodiment, the multi-modal tumor ablation probe system provided in the present application is tested, and the testing method is as follows: the multi-modal tumor ablation probe 1 is inserted into the bio-mimetic colloid, freezing is performed for 12 minutes, and then the size of an iceball generated by freezing is measured using a vernier caliper. And (3) testing results: in the freezing process, an ellipsoidal ice ball is formed in a target area, and the maximum diameter of the ice ball is 4.5cm and the length of the ice ball is 6.2cm through measurement; meanwhile, no frost or freezing state appears in other places outside the target area, which shows that the multi-modal tumor ablation probe system can well protect normal tissues from being damaged. The test result shows that the multi-modal tumor ablation probe system in the embodiment can achieve a good freezing effect in the micro-scale probe, control and adjustment of the cooling rate and the freezing range in the freezing process are realized, and the purpose of rapid freezing is achieved.
It is noted that, in the present patent application, relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, the use of the verb "comprise a" to define an element does not exclude the presence of another, same element in a process, method, article, or apparatus that comprises the element. In the present patent application, if it is mentioned that a certain action is executed according to a certain element, it means that the action is executed according to at least the element, and two cases are included: performing the action based only on the element, and performing the action based on the element and other elements. Multiple, etc. expressions include 2, 22 kinds, more than 2 times, more than 2 kinds.
This specification includes combinations of the various embodiments described herein. Separate references to "one embodiment" or a particular embodiment, etc., do not necessarily refer to the same embodiment; however, these embodiments are not mutually exclusive, unless indicated as mutually exclusive or as would be apparent to one of ordinary skill in the art. It should be noted that the term "or" is used in this specification in a non-exclusive sense unless the context clearly dictates otherwise.
All documents mentioned in this application are to be considered as being incorporated in their entirety into the disclosure of this application so as to be subject to modification as necessary. Further, it is understood that various changes or modifications may be made to the present application by those skilled in the art after reading the above disclosure of the present application, and such equivalents are also within the scope of the present application as claimed.
Claims (10)
1. A probe system, comprising: the device comprises a liquid nitrogen storage tank, a gas-liquid separation device, a valve block, a probe, an exhaust electromagnetic valve and a control device;
the inlet of the gas-liquid separation device is connected with the liquid nitrogen storage tank to input liquid nitrogen; a liquid outlet of the gas-liquid separation device is connected with the valve block, and liquid nitrogen is input into the probe through the valve block so as to refrigerate the probe; an exhaust port of the gas-liquid separation device is connected to the exhaust electromagnetic valve;
the valve block is internally provided with a first temperature sensor and a first pressure sensor which are used for measuring the temperature value and the pressure value of the liquid nitrogen flowing through the valve block;
the control device is used for controlling the opening and closing proportion of the exhaust electromagnetic valve according to the temperature value T1 output by the first temperature sensor and the pressure value P output by the pressure sensor in the following way:
calculating the liquid nitrogen-gas liquid ratio alpha (P, T1) in real time according to the liquid nitrogen phase change heat exchange principle;
and controlling the opening and closing ratio of the exhaust electromagnetic valve to ensure that the liquid nitrogen gas-liquid ratio alpha input into the probe is greater than or equal to 0.9.
2. The probe system of claim 1, wherein the exhaust solenoid valve is periodically opened and closed, the opening and closing ratio being a ratio of a length of time the exhaust solenoid valve is opened to a length of time the exhaust solenoid valve is closed.
3. The probe system of claim 1, further comprising a waste treatment device, a loop solenoid valve;
the outlet of the probe is connected to the loop electromagnetic valve, waste liquid is input to the waste liquid treatment device through the loop electromagnetic valve, the outlet of the exhaust electromagnetic valve is also connected to the waste liquid treatment device, and the waste liquid treatment device is used for treating the input waste liquid into normal-temperature gas and then discharging the gas into the air.
4. The probe system of claim 3, wherein the waste fluid treatment device comprises a collection cartridge, a heater, a second temperature sensor, and a fan; the waste liquid discharged by the exhaust electromagnetic valve and the loop electromagnetic valve is fully mixed in the collecting box, and then the on-off state of the heater is controlled through the temperature information monitored by the second temperature sensor, so that the waste liquid is heated to normal temperature gas; the fan works to form negative pressure, so that the heated gas is discharged into the air.
5. A multi-modal tumor ablation probe system comprising the probe system of claim 3 and a radio frequency generating device;
the radio frequency generating device is used for providing radio frequency current to the probe so that the probe is heated;
the control device is also used for controlling the radio frequency generation device.
6. The multi-modal tumor ablation probe system of claim 5, wherein the outer diameter of the probe is less than or equal to 2mm; the ratio of the inlet air area to the outlet air area is between 0.1 and 0.6; the inner diameter of the air inlet pipe is more than or equal to 0.5mm; the distance between the mouth of the air inlet pipe and the needle point is less than or equal to 6mm.
7. The multi-modality tumor ablation probe system of claim 5, wherein the probe includes a treatment section for tumor freezing and heating, an insulation section for thermal and electrical insulation of normal tissue, a connection section for temperature signal, radio frequency signal, and liquid nitrogen transmission;
during freezing, liquid nitrogen flows into the tube cavity of the treatment section through the air inlet pipe to perform phase change heat exchange, and then flows out of the probe through the air return channel; during heating, the probe inputs radio frequency current through a radio frequency signal wire, and the outside of the needle rod except the treatment section is wrapped with an electric insulation layer so as to ensure that radio frequency energy is only output from the treatment section;
the treatment section comprises a temperature sensor for feeding back temperature information in real time during the treatment process.
8. The multi-modal tumor ablation probe system of claim 5, wherein the probe is frozen using a liquid nitrogen pressure of 1MPa or less.
9. The multi-modal tumor ablation probe system according to any of claims 5-8, wherein the system is cryogenically controlled by:
acquiring the liquid nitrogen pressure P and the temperature T1 of an input probe in real time through a pressure sensor and a first temperature sensor in the valve block;
calculating the liquid nitrogen-gas liquid ratio alpha (P, T1) in real time according to the liquid nitrogen phase change heat exchange principle;
outputting an opening and closing proportion control function f (t) of the exhaust electromagnetic valve to ensure that the liquid nitrogen gas-liquid ratio alpha of the input probe is greater than or equal to 0.9;
calculating liquid nitrogen flow Q (P, alpha) in real time according to the liquid nitrogen pressure P and the liquid nitrogen-liquid ratio alpha;
and outputting an opening and closing proportion control function g (t) of the loop electromagnetic valve to realize the flow control of the liquid nitrogen flowing through the probe, thereby realizing different freezing rates and freezing ranges.
10. The multi-modal tumor ablation probe system of claim 9, wherein the system is heat controlled by:
determining a target heating range d _ a according to the freezing range;
according to a precooled radio frequency heating heat transfer principle, establishing a relation function d (T2, T) of a radio frequency heating temperature boundary d and a probe central temperature T2, and determining a target heating temperature T2_ a according to a target heating range d _ a;
collecting tissue impedance (Z), heating power (p) and probe temperature measurement temperature (T2) parameters in real time;
and establishing a radio frequency power and temperature accurate control function T2 (Z, p, T) by combining a multi-modal ablation heating model, adjusting the input heating power p (Z, T2_ a, T) according to the target heating temperature T2_ a, and realizing real-time accurate control of a heating temperature field, thereby realizing multi-modal tumor ablation with a heating area and a freezing area completely superposed.
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| CN113576649B (en) * | 2021-07-22 | 2022-08-23 | 海杰亚（北京）医疗器械有限公司 | Electrical control system for minimally invasive tumor treatment |
| CN115337093A (en) * | 2022-09-06 | 2022-11-15 | 上海美杰医疗科技有限公司 | Ablation system |
| CN115220496B (en) * | 2022-09-20 | 2022-12-20 | 南京伟思医疗科技股份有限公司 | Temperature control method, device and equipment of sectional type radio frequency treatment equipment |
| CN115530962A (en) * | 2022-10-09 | 2022-12-30 | 上海美杰医疗科技有限公司 | Thermal ablation system and method for controlling flowing medium in thermal ablation system |
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