CN107307901B - Cryoablation system - Google Patents

Cryoablation system Download PDF

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CN107307901B
CN107307901B CN201710481942.XA CN201710481942A CN107307901B CN 107307901 B CN107307901 B CN 107307901B CN 201710481942 A CN201710481942 A CN 201710481942A CN 107307901 B CN107307901 B CN 107307901B
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cooling fluid
balloon
catheter
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fluid
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CN107307901A (en
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冯骥
龚杰
彭博
耿坦
韩博阳
刘彦斌
华新
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Synaptic Medical Beijing Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00005Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00023Cooling or heating of the probe or tissue immediately surrounding the probe with fluids closed, i.e. without wound contact by the fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053Mechanical features of the instrument of device
    • A61B2018/00214Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022Balloons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345Vascular system
    • A61B2018/00351Heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577Ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0212Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques using an instrument inserted into a body lumen, e.g. catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0231Characteristics of handpieces or probes
    • A61B2018/0262Characteristics of handpieces or probes using a circulating cryogenic fluid

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Abstract

The invention provides a cryoablation system, which comprises a catheter, a fluid delivery unit and a control unit; the catheter comprises a central cavity and a balloon positioned at the distal end of the catheter, wherein an input channel for inputting cooling fluid into the balloon and an output channel for outputting the cooling fluid from the balloon are arranged in the central cavity; the fluid delivery unit supplies and discharges cooling fluid; the control unit controls the fluid delivery unit. When the cryoablation system works in a steady state, a balloon at the far end of the catheter always has a stable pressure value, the temperature fluctuation is small, the success rate of the treatment operation is high, and the risk is small; with the same ablation depth, there is a more optimal ablation pattern.

Description

Cryoablation system
Technical Field
The present invention relates to a cryoablation system, and more particularly, to a cryoablation system with steady state control of cooling fluid.
Background
At present, the invasive medical minimally invasive technology for arrhythmia and other diseases has been researched, and the technology for radio frequency ablation therapy has been used clinically. Conventional radio frequency ablation achieves treatment by releasing radio frequency current at a specific location of the heart to burn tissue to necrosis. The disadvantages that patients need to bear the pain caused by high temperature in the operation, more complications occur after the operation and the like are also exposed one by one.
In view of the treatment risk of the rf ablation on the patient, the cryoablation interventional therapy technology is also beginning to be applied clinically. The cryoablation adopts liquefied gas of liquid nitrogen as a cooling fluid source, takes away tissue heat through the absorption and evaporation of the liquid nitrogen, reduces the temperature of a target part, and destroys abnormal electrophysiological cell tissues, thereby reducing the risk of arrhythmia.
Currently, there is a need for more optimized cryoablation systems.
Disclosure of Invention
The invention aims to provide a cryoablation system, which comprises a catheter, a fluid delivery unit and a control unit; the catheter comprises a central cavity and a balloon positioned at the distal end of the catheter, wherein an input channel for inputting cooling fluid into the balloon and an output channel for outputting the cooling fluid from the balloon are arranged in the central cavity; the fluid delivery unit supplies and discharges cooling fluid; the control unit controls the fluid delivery unit.
Preferably, the control unit adjusts the flow rate of the input cooling fluid by controlling the fluid delivery unit, so that the cooling fluid flowing through the balloon enters a steady state within a set time.
Preferably, the set time is a parameter pre-stored in the control unit and can be adjusted by a human-computer interaction unit of the control unit.
Preferably, the input side of the input channel of the catheter is connected with the fluid conveying pipe of the fluid conveying unit, and the output side of the output channel of the catheter is connected with the fluid recovery pipe of the fluid conveying unit; an input side pressure sensor and an input side flow regulating valve are arranged on the input side of the input channel of the conduit; and an outflow-side mass flow sensor, an outflow-side pressure sensor, and an outflow-side flow regulating valve are provided on the outflow side of the outflow passage of the catheter.
Preferably, the control unit calculates an outflow side theoretical pressure value of the outflow channel of the conduit, compares the outflow side theoretical pressure value with a pressure value measured by the outflow side pressure sensor, and adjusts the flow rate of the cooling fluid input to the conduit by using a PID algorithm, so that the cooling fluid enters a steady state.
Preferably, the theoretical pressure value of the outflow side of the outflow channel of the catheter is calculated by the following equation:
P=c*Q2,
c=b/(T1*ρ1/(T2*ρ2)-1),
Figure GDA0002484012920000021
where P is the theoretical pressure on the outflow side, Q is the flow rate of the cooling fluid in the pipeline between the balloon and the mass flow meter on the outflow side, T1 is the temperature of the cooling fluid in the balloon, ρ 1 is the density of the cooling fluid in the balloon, T2 is the temperature of the cooling fluid near the mass flow meter, ρ 2 is the density of the cooling fluid near the mass flow meter, L is the length of the pipeline between the balloon and the mass flow meter, a is the cross-sectional area of the pipeline between the balloon and the mass flow meter, a is the coefficient of friction of the pipeline between the balloon and the mass flow meter, ρ is the density of the cooling fluid in the pipeline between the balloon and the mass flow meter, and c and b are intermediate calculation variables.
Preferably, the control unit compares the theoretical pressure with a pressure value measured by the outflow side pressure sensor, and when the measured pressure value of the outflow side pressure sensor is greater than the theoretical pressure, the control unit increases the opening degree of the outflow side flow rate adjustment valve and/or decreases the opening degree of the input side flow rate adjustment valve by a PID algorithm to reduce the input amount of the cooling fluid; and when the measured pressure value of the outflow side pressure sensor is less than the theoretical pressure, the control unit decreases the opening degree of the outflow side flow rate adjustment valve and/or increases the opening degree of the input side flow rate adjustment valve by a PID algorithm to increase the input amount of the cooling fluid.
Preferably, when the cooling fluid flowing through the balloon reaches a steady state, the amount of cooling fluid input to the balloon is equal to the amount of cooling fluid exiting the balloon.
Preferably, the control unit performs pressure feedback control through the input side flow regulating valve and/or the output side flow regulating valve, so that the cooling fluid immediately achieves phase change after entering the balloon for injection, and a certain amount of cooling fluid which can be fully gasified is continuously input into the balloon during treatment.
Preferably, the cooling fluid reaches a supercritical state immediately after being injected into the balloon.
Preferably, the cryoablation system is further provided with a plurality of temperature sensors for sensing the temperature of the cooling fluid. .
In the cryoablation system according to a preferred embodiment of the present invention, the input amount of the cooling fluid can be effectively controlled by steady-state control of the cooling fluid, so that the cooling fluid can be effectively vaporized in the balloon at the distal end of the catheter, and the cooling effect of the balloon can be optimized. When the cryoablation system works in a steady state, a balloon at the far end of the catheter always has a stable pressure value, the temperature fluctuation is small, the success rate of the treatment operation is high, and the risk is small; with the same ablation depth, there is a more optimal ablation pattern.
Drawings
The invention will be described in more detail below with reference to embodiments and the accompanying drawings, in which:
FIG. 1 is a schematic structural view of a cryoablation system according to an embodiment of the present invention;
FIG. 2 is a schematic illustration of the connection of the input and discharge sides of the conduit to the fluid delivery unit;
FIG. 3 illustrates a temperature profile according to an embodiment of the present invention;
FIG. 4 is a schematic view of a catheter configuration according to an embodiment of the present invention; and
FIG. 5 is a model diagram of calculating theoretical pressure at steady state according to one embodiment of the present invention.
Detailed Description
The technical solutions of the present invention will be described in further detail below by way of exemplary embodiments and with reference to the drawings, but the present invention is not limited to the following embodiments.
Fig. 1 shows a schematic structural view of a cryoablation system 10 according to an embodiment of the present invention. As shown in FIG. 1, the system 10 may include a catheter 12, a fluid delivery unit 13, and a control unit 14.
The catheter 12 comprises an elongate main tube comprising a central lumen with an expandable element, such as a balloon, disposed at its distal end. Distal generally refers to the end of the patient distal from the operator and proximal generally refers to the end proximal to the operator. One or more channels or conduits, such as fluid delivery channels, fluid recovery channels, etc., are provided within the central chamber of the main body tube to provide fluid, mechanical and/or electrical communication between the proximal and distal portions of the main body tube. The proximal end of the fluid delivery channel extends to the proximal end of the catheter, for example in connection with a fluid delivery tube of a cooling fluid storage reservoir of the fluid delivery unit 13. The distal end of the fluid delivery channel extends into the balloon, which may be coiled or wrapped around a portion of the shaft within the lumen of the balloon, and injects a cooling fluid through one or more holes into the balloon. The distal end of the fluid recovery channel is communicated with the lumen of the balloon, the proximal end of the fluid recovery channel extends to the proximal end of the catheter through the main tube, and the gasified cooling fluid flows into the cooling fluid recovery system through the fluid recovery tube of the fluid delivery unit 13 connected with the fluid recovery channel and can be discharged into the atmosphere.
Fig. 4 shows an exemplary configuration of a catheter having an operating handle and various interfaces disposed at its proximal end, according to one embodiment of the present invention.
The fluid delivery unit 13 includes a container for providing delivery and discharge functions for the cooling fluid, and a piping, such as a cooling fluid storage container 36, a cooling fluid recovery system, and the like. The fluid delivery unit 13 further comprises a pump, a valve, a heat exchange mechanism, and control elements, such as a pressure sensor, a mass flow sensor, a temperature sensor, etc., for performing data acquisition and flow regulation during delivery, recovery and/or recirculation of the cooling fluid delivered to the balloon at the distal end of the catheter. The heat exchanging mechanism may control the temperature of the cooling fluid prior to delivery to the balloon at the distal end of the catheter. In addition, the fluid delivery unit 13 also includes one or more check valves or pressure relief valves CV that open to the atmosphere or to a cooling fluid recovery system if the pressure level or flow within a portion of the system exceeds a required or predetermined level. The pressure pump of the fluid delivery unit 13 may control the pressure of the cooling fluid.
The control unit 14 may include one or more controllers, processors, and/or software modules, including in one embodiment, for example, a programmable control unit 41, and a human-machine interaction (HMI) unit 42, among others. These controllers, processors and/or software modules contain instructions or algorithms for controlling the fluid delivery unit 13, as will be described in more detail below.
According to one embodiment of the present invention, the programmable control unit 41 centrally processes, senses input signals and outputs commands to the actuators of the fluid delivery unit 13, providing automated operation and sequence or process of executing the target. Through a Human Machine Interaction (HMI) unit 42, an operator can provide on-site instructions or modify parameters, etc., and the programmable control unit 41 receives the instructions and/or parameters and sends the instructions to the actuators of the fluid delivery unit 13 through calculations.
Fig. 2 shows a schematic view of the connection of the input side and the output side of the conduit 12 to the fluid delivery unit 13. As shown in fig. 2, the input side of the conduit 12 is connected to the fluid delivery pipe of the fluid delivery unit 13, and the discharge side of the conduit 12 is connected to the fluid recovery pipe. An input-side pressure sensor 31, an input-side flow rate adjustment valve 32, an input-side temperature sensor, and the like may be provided on the input side of the pipe 12, and a discharge-side mass flow rate sensor 33, a discharge-side pressure sensor 34, a discharge-side flow rate adjustment valve 35, a discharge-side temperature sensor, and the like may be provided on the discharge side of the pipe 12. The pressure or flow of the cooling fluid is controlled by the fluid delivery unit 13 and then delivered into the balloon at the distal end of the catheter 12. The cooling fluid is discharged out of the conduit 12 through the fluid recovery tube at the discharge side after the state transition is completed.
According to an embodiment of the present invention, the input side pressure sensor 31 on the input side of the conduit 12 feeds back the input pressure of the cooling fluid, and the discharge side pressure sensor 34 on the discharge side of the conduit 12 feeds back the discharge pressure of the cooling fluid. According to the present invention, it is necessary to control the cooling fluid so that the pressure of the cooling fluid in the conduit of the cryoablation system is maintained at a preset value or fluctuates within a small range around the preset value in the case where a certain flow rate of the cooling fluid is continuously supplied to the balloon of the cryoablation system (thereby providing a continuous cooling amount to the affected tissue), so that the cooling fluid reaches a gas-liquid equilibrium in the balloon. That is, the delivery amount of the cooling fluid is controlled such that the cooling fluid reaches a steady state in the balloon of the cryoablation system, which may be referred to as a steady state of the cryoablation system or a steady state of the cooling fluid.
The discharge side theoretical pressure value at the discharge side of the catheter 12 in the steady state of the cooling fluid can be calculated, compared with the pressure value actually measured by the discharge side pressure sensor 34, and then calculated by the PID algorithm of the control unit 14 to adjust the flow rate of the cooling fluid, so that the cryoablation system enters the steady state.
According to an embodiment of the present invention, the length of time from the beginning of the cryoablation treatment to the cooling fluid entering steady state may be set or modified by the Human Machine Interaction (HMI) unit 42 before the cooling fluid enters the flow regulating valve 32. The length of time may have a default value set in advance and stored in the control unit. During this time period, the control unit adjusts the cooling fluid to a certain flow rate according to the above-described embodiment. An exemplary calculation method of the discharge-side theoretical pressure value of the discharge side of the conduit 12 to achieve the steady state of the cooling fluid will be specifically described below with reference to fig. 5.
In fig. 5, the meanings of the respective reference numerals are as follows:
p1 is the balloon internal pressure;
p2 is theoretical pressure (set pressure);
l is the length of the pipeline between the balloon and the discharge side mass flow meter mounting part;
a discharge-side flow rate adjusting valve 35;
33 is a discharge side mass flow meter;
the model is corresponding to P1-P2 ═ a ^ L ^ ρ ^ upsilon2/2d (1)
Wherein a is the friction coefficient of the pipeline, L is the distance between the pipelines, ρ is the density of the cooling fluid in the pipeline, ρ is the flow velocity of the fluid, and d is the diameter of the pipeline.
Q is rho, A, upsilon (Q is the flow of the pipeline, A is the sectional area of the pipeline)
A=Πd2/4
Can know d2=4A/П,υ=Q/ρA
Thus, there are:
Figure GDA0002484012920000051
wherein
Figure GDA0002484012920000052
Under certain vacuum conditions, the mass flow meter 33 measures a value, i.e. the amount of cooling fluid flowing out of the pipe, for the case where the balloon is kept fully inflated when the system is in a steady state under dynamic conditions.
According to the gas equation under the ideal state, P1V 1/T1 n 1R is arranged in the balloon, V1 is the volume of the balloon, T1 is the temperature in the balloon, the density is rho 1, and n1 is the amount of cooling fluid;
considering the line near the valve 35 or the discharge-side mass flow meter 33, there are P2 × V2/T2 × n2 × R, V2 is the line volume, T2 is the temperature of the cooling fluid in the line, the density is ρ 2, and n2 is the amount of the cooling fluid;
wherein n1 ═ M1/M ═ ρ 1 ═ V1/M, n2 ═ M2/M ═ ρ 2 ═ V2/M
Obtaining P1V 1/(T1 n1) ═ P2V 2/(T2 n2)
Namely: p1 ═ P2 × T1 × ρ 1/(T2 × ρ 2)
Substituting P1-P2 ═ (T1 ═ ρ 1/(T2 ═ ρ 2) -1) P2 ═ b ═ Q2
Wherein T2 is known, T1 is known,
it is known that P2 ═ c × Q2 (4)
Wherein c ═ b/(T1 · ρ 1/(T2 · ρ 2) -1) (5)
Under different pressures and temperatures, from N2The O-physical properties revealed that ρ 1 was much larger than ρ 2, i.e., T1 × ρ 1/(T2 × ρ 2) -1>0。
In addition, for ρ, ρ 1, and ρ 2, the values of the pressure and temperature detected by the cryoablation system can be determined by a look-up table. For example, the temperature in the balloon can be actually detected; the maximum design pressure of the balloon is 30PSI, and in the actual ablation process, the pressure in the balloon is kept at 18PSI, so that the balloon can be completely expanded against the blood pressure, and enough safety margin is reserved. For convenience of calculation, the pressure value in the balloon can be directly referred to in the algorithm to calculate the theoretical pressure on the exhaust side. The temperature and pressure in the line L can be measured separately or the temperature and pressure of the cooling fluid measured at the discharge side can be used.
The control unit compares the calculated theoretical pressure with the pressure value measured by the discharge side pressure sensor 34. When the measured value of the discharge side pressure sensor 34 is greater than the theoretical pressure, the opening degree of the discharge side flow rate adjustment valve 35 may be increased and/or the opening degree of the input side flow rate adjustment valve 32 may be decreased at this time to decrease the input amount of the cooling fluid, by the PID calculation of the control unit 14. When the measured value of the discharge side pressure sensor 34 is smaller than the theoretical pressure, the opening degree of the discharge side flow rate adjustment valve 35 may be decreased and/or the opening degree of the input side flow rate adjustment valve 32 may be increased at this time to increase the input amount of the cooling fluid by the PID calculation of the control unit 14. The adjustment is made to continuously correct the amount of cooling fluid actually input at the input side of the conduit 12 and the amount of cooling fluid actually output at the output side.
The adjustment of both the opening degree of the input-side flow rate adjustment valve 32 and the opening degree of the discharge-side flow rate adjustment valve 35 can be balanced according to the set length of time from the start of the cryoablation treatment to the cooling fluid entering the steady state. For example, when the length of time is small, the opening degree of the input-side flow rate adjustment valve 32 will be increased relatively quickly, while the opening degree of the discharge-side flow rate adjustment valve 35 is adjusted accordingly, to quickly achieve a steady state.
According to the preferred embodiment of the invention, the amount of the cooling fluid in the balloon at the distal end of the input catheter 12 is equal to the amount of the cooling fluid in the balloon of the outflow catheter in a steady state, the phase change of the cooling fluid can be immediately achieved after the cooling fluid enters the balloon for injection through the pressure feedback control of the input side flow regulating valve, and a certain amount of cooling fluid which can be fully gasified is continuously input into the balloon during treatment. Preferably, the cooling fluid is able to reach a supercritical state immediately after being injected into the balloon, so that the temperature reached by the balloon can be minimal.
Through the control mode of the cooling fluid, the input quantity of the cooling fluid can be effectively controlled, the cooling fluid can be effectively gasified in the saccule at the far end of the catheter, and the refrigeration effect of the saccule is optimal. And when the cryoablation system works in a steady state, the balloon at the far end of the catheter always has a stable pressure value and smaller temperature fluctuation, and a more optimized ablation mode is realized under the condition of reaching the same ablation depth.
FIG. 3 shows a temperature profile according to an embodiment of the invention. After the cooling fluid is accurately controlled by the control mode and the algorithm, the temperature change in the balloon at the distal end of the catheter 12 per unit time can be effectively controlled. Is beneficial to the cryoablation treatment of different pathological tissues of patients, and increases the treatment flexibility of the system under different conditions.
The embodiments of the present invention are not limited to the above-described examples, and various changes and modifications in form and detail may be made by those skilled in the art without departing from the spirit and scope of the present invention, and these are considered to fall within the scope of the present invention.

Claims (7)

1. A cryoablation system comprising a catheter, a fluid delivery unit, and a control unit; the catheter comprises a central cavity and a balloon positioned at the distal end of the catheter, wherein an input channel for inputting cooling fluid into the balloon and an output channel for outputting the cooling fluid from the balloon are arranged in the central cavity; the fluid delivery unit supplies and discharges cooling fluid; the control unit controls the fluid conveying unit;
the input side of the input channel of the catheter is connected with the fluid delivery pipe of the fluid delivery unit, and the output side of the output channel of the catheter is connected with the fluid recovery pipe of the fluid delivery unit; an input side pressure sensor and an input side flow regulating valve are arranged on the input side of the input channel of the conduit; an outflow side mass flow sensor, an outflow side pressure sensor and an outflow side flow regulating valve are arranged on the outflow side of the outflow channel of the catheter;
the control unit performs pressure feedback control through the input side flow regulating valve and/or the output side flow regulating valve so that the cooling fluid flowing through the balloon enters a stable state within a set time, the cooling fluid immediately achieves phase change after entering the balloon for injection, a certain amount of cooling fluid capable of being fully gasified is continuously input into the balloon during treatment, and the temperature change in the balloon at the far end of the catheter in unit time is accurately controlled;
the set time is a parameter pre-stored in the control unit and can be adjusted through a human-computer interaction unit of the control unit.
2. The system of claim 1, wherein the control unit calculates a theoretical pressure value at the outflow side of the outflow channel of the catheter and compares the theoretical pressure value with a pressure value measured by the outflow side pressure sensor, and adjusts the flow rate of the cooling fluid supplied to the catheter using a PID algorithm so that the cooling fluid enters a steady state.
3. The cryoablation system of claim 2, wherein the theoretical pressure value at the outflow side of the outflow channel of the catheter is calculated by the following equation:
P=c×Q2
c=b/(T1×ρ1/(T2×ρ2)-1),
Figure FFW0000022099370000011
where P is the theoretical pressure on the outflow side, Q is the flow rate of the cooling fluid in the pipeline between the balloon and the mass flow meter on the outflow side, T1 is the temperature of the cooling fluid in the balloon, ρ 1 is the density of the cooling fluid in the balloon, T2 is the temperature of the cooling fluid near the mass flow meter, ρ 2 is the density of the cooling fluid near the mass flow meter, L is the length of the pipeline between the balloon and the mass flow meter, a is the cross-sectional area of the pipeline between the balloon and the mass flow meter, a is the coefficient of friction of the pipeline between the balloon and the mass flow meter, ρ is the density of the cooling fluid in the pipeline between the balloon and the mass flow meter, and c and b are intermediate calculation variables.
4. The cryoablation system of claim 3, said control unit comparing said theoretical pressure with a pressure value measured by an outflow side pressure sensor, said control unit increasing the opening of the outflow side flow regulating valve and/or decreasing the opening of the input side flow regulating valve to reduce the input amount of cooling fluid by a PID algorithm when the measured pressure value of the outflow side pressure sensor is greater than the theoretical pressure; and when the measured pressure value of the outflow side pressure sensor is less than the theoretical pressure, the control unit decreases the opening degree of the outflow side flow rate adjustment valve and/or increases the opening degree of the input side flow rate adjustment valve by a PID algorithm to increase the input amount of the cooling fluid.
5. The cryoablation system of claim 1, wherein an amount of cooling fluid input to the balloon is equal to an amount of cooling fluid output from the balloon when cooling fluid flow through the balloon reaches a steady state.
6. The cryoablation system of claim 1, said cooling fluid reaching a supercritical state immediately after being injected into the balloon.
7. The cryoablation system of claim 1 further provided with a plurality of temperature sensors that sense the temperature of the cooling fluid.
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