CN114129254A - Dynamic pressure balance system in balloon of cryoablation instrument - Google Patents

Dynamic pressure balance system in balloon of cryoablation instrument Download PDF

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CN114129254A
CN114129254A CN202111507120.7A CN202111507120A CN114129254A CN 114129254 A CN114129254 A CN 114129254A CN 202111507120 A CN202111507120 A CN 202111507120A CN 114129254 A CN114129254 A CN 114129254A
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balloon
pressure
gas
control valve
proportional control
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CN114129254B (en
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叶振宇
潘幸珍
袁小勇
张建新
孙佳
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Suzhou Haiyu Xinchen Medical Technology Co ltd
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Suzhou Haiyu Xinchen Medical Technology Co ltd
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    • 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
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • 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
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart

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Abstract

The embodiment of the specification provides a dynamic pressure balance system in a cryoablation instrument balloon, which comprises a refrigerant gas pressure tank, a liquefied heat exchanger, a catheter, a freezing balloon, a control unit, a data acquisition unit and a pressure regulation unit, wherein the refrigerant gas pressure tank is connected with the liquefied heat exchanger; the control unit is in communication connection with the data acquisition unit and the pressure regulation unit; the data acquisition unit comprises a plurality of measuring points and a flowmeter; the plurality of measuring points are used for detecting the gas state of the target position; the flow meter is used for detecting the volume flow of the refrigerant gas; the pressure adjusting unit comprises a balloon front end proportion adjusting valve, a balloon rear end proportion adjusting valve and a vacuum pump; the control unit adjusts the flow areas of the balloon front end proportion adjusting valve and the balloon rear end proportion adjusting valve and the vacuumizing speed of the vacuum pump in real time based on the gas state and the volume flow data acquired by the data acquisition unit.

Description

Dynamic pressure balance system in balloon of cryoablation instrument
Technical Field
The specification relates to the field of medical instruments, in particular to a dynamic pressure balancing system in a balloon of a cryoablation instrument.
Background
Atrial fibrillation is the most common clinical sustained arrhythmia, in recent years, the application of a freezing balloon to atrial fibrillation ablation is an important technical breakthrough, and the freezing balloon releases freezing energy to cause myocardial cells at the muscle sleeve at the joint of a pulmonary vein and the left atrium to disintegrate and necrose to cause electric conduction block, so that atrial fibrillation is effectively treated.
A plurality of problems can occur due to abnormal pressure control in the saccule, and the treatment process is not facilitated to be smoothly carried out, so that the accurate control of the pressure in the saccule is the basis for stable cryoablation treatment, and a dynamic pressure balance system in the saccule of the cryoablation instrument is needed to be provided.
Disclosure of Invention
One of the embodiments of the present specification provides a dynamic pressure balance system in a cryoablation instrument balloon, which includes a refrigerant gas pressure tank, a liquefaction heat exchanger, a catheter, a cryoballoon, a control unit, a data acquisition unit, and a pressure regulation unit; the control unit is in communication connection with the data acquisition unit and the pressure regulation unit; the data acquisition unit comprises a plurality of measuring points and a flowmeter; the plurality of measuring points are used for detecting the gas state of the target position; the flow meter is used for detecting the volume flow of the refrigerant gas; the pressure adjusting unit comprises a balloon front end proportion adjusting valve, a balloon rear end proportion adjusting valve and a vacuum pump; the control unit adjusts the flow areas of the balloon front end proportion adjusting valve and the balloon rear end proportion adjusting valve and the vacuumizing speed of the vacuum pump in real time based on the gas state and the volume flow data acquired by the data acquisition unit.
Drawings
The present description will be further explained by way of exemplary embodiments, which will be described in detail by way of the accompanying drawings. These embodiments are not intended to be limiting, and in these embodiments like numerals are used to indicate like structures, wherein:
FIG. 1 is a schematic diagram of an application scenario of a dynamic pressure balancing system within a cryoablator balloon according to some embodiments herein;
FIG. 2 is a schematic structural view of a dynamic pressure balancing system within a cryoablator balloon according to some embodiments herein;
FIG. 3 is a control logic diagram of a dynamic pressure balancing system within a cryoablator balloon according to some embodiments herein;
fig. 4 is a control logic diagram of a system for dynamic balancing of pressure within a cryoablator balloon when nitrous oxide is the refrigerant according to the teachings of the present disclosure.
Reference numerals: 100 is a main machine, 110 is a communication cable, 120 is a coaxial cable, 210 is a refrigerant gas pressure tank, 220 is a liquefaction heat exchanger, 230 is a freezing balloon, 241 is a first measuring point, 242 is a second measuring point, 243 is a third measuring point, 244 is a fourth measuring point, 245 is a fifth measuring point, 246 is a flow meter, 251 is a balloon front end proportional control valve, 252 is a balloon rear end proportional control valve, 253 is a vacuum pump, 260 is a catheter and 300 is a handle.
Detailed Description
In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings used in the description of the embodiments will be briefly described below. It is obvious that the drawings in the following description are only examples or embodiments of the present description, and that for a person skilled in the art, the present description can also be applied to other similar scenarios on the basis of these drawings without inventive effort. Unless otherwise apparent from the context, or otherwise indicated, like reference numbers in the figures refer to the same structure or operation.
It should be understood that "system", "apparatus", "unit" and/or "module" as used herein is a method for distinguishing different components, elements, parts, portions or assemblies at different levels. However, other words may be substituted by other expressions if they accomplish the same purpose.
As used in this specification and the appended claims, the terms "a," "an," "the," and/or "the" are not intended to be inclusive in the singular, but rather are intended to be inclusive in the plural, unless the context clearly dictates otherwise. In general, the terms "comprises" and "comprising" merely indicate that steps and elements are included which are explicitly identified, that the steps and elements do not form an exclusive list, and that a method or apparatus may include other steps or elements.
Flow charts are used in this description to illustrate operations performed by a system according to embodiments of the present description. It should be understood that the preceding or following operations are not necessarily performed in the exact order in which they are performed. Rather, the various steps may be processed in reverse order or simultaneously. Meanwhile, other operations may be added to the processes, or a certain step or several steps of operations may be removed from the processes.
Fig. 1 is a schematic diagram of an application scenario of a dynamic pressure balancing system within a cryoablator balloon according to some embodiments of the present disclosure.
In some embodiments, the cryoablator as shown in fig. 1 may include a host 100, a cryoballoon 230, a catheter 260, a handle 300, wherein the host 100 may be used to control the pressure within the cryoballoon 230, as well as the flow rate of the refrigerant. In some embodiments, the handle 300 may be used to perform a cryosurgical operation, such as adjusting the orientation of the cryoballoon 230, and the like. In some embodiments, the catheter 260 may be used to deliver a refrigerant to the cryoballoon 230. In some embodiments, host 100 may communicate with handle 300 via communication cable 110. Further, the main unit 100 may exchange refrigerant with the handle 300 through the coaxial cable 120.
In some embodiments, the cryoablation therapy procedure consists essentially of: inflating the cryoballoon 230 with gas from the device self-test process; after the freezing balloon 230 is positioned, the refrigerant is filled for refrigeration, the pressure of the refrigerant is required to be kept at the pressure of the liquefaction section, the flow rate of the refrigerant is required to be controlled, and the pressure in the balloon is controlled to be stable.
In some embodiments, after the valve of the refrigerant gas pressure tank is opened in the main unit 100, the main unit 100 performs a self-checking process to ensure that the equipment can be safely used. After the cryoablation process is started, the refrigerant may perform a series of operations such as pressure reduction, pressure control, and flow rate adjustment inside the main body 100, so as to re-liquefy the refrigerant gas from the refrigerant gas pressure tank, transport the refrigerant gas to the catheter 260 through the coaxial cable 120, and transport the refrigerant gas to the cryoballoon 230 through the catheter 260. Further, after the liquefied refrigerant enters the cryoballoon 230, the pressure is rapidly reduced, and at this time, the pressure in the cryoballoon 230 is much lower than the saturated vapor pressure of the liquefied refrigerant, so that the refrigerant is vaporized again, and the heat of the surrounding environment is taken away, thereby achieving the purpose of cryoablation treatment. In some embodiments, the refrigerant inside the cryoballoon 230 is vaporized by heat absorption and is discharged in time, and the refrigerant gas returns to the handle 300 through the conduit 260, returns to the main body 100 through the coaxial cable 120 after being detected by the sensor of the handle 260, and is discharged after a series of processes inside the main body 100.
In some embodiments, the following problems may occur if the pressure control within the balloon is lost: if the pressure in the freezing balloon 230 is too high, the evaporation temperature may be increased, and the total refrigerating capacity of the freezing balloon 230 is correspondingly reduced; if the pressure in the freezing balloon 230 increases, the pressure borne by the freezing balloon 230 increases, and the risk of rupture exists; if the air-pumping speed of the vacuum pump is too fast, the freezing balloon 230 may be contracted during the refrigeration process, resulting in poor therapeutic effect.
In some embodiments, during the cryoablation, as the temperature difference between the freezing balloon 230 and the outside decreases, the heat exchange amount between the outside and the freezing balloon 230 gradually decreases, and if the flow rate of the refrigerant is not properly controlled, a part of the refrigerant may not be completely evaporated and stored in the freezing balloon 230.
Therefore, effective control of the pressure inside the balloon is the basis for stable operation of the cryoablation instrument. At present, some cryoablation instruments regulate the pressure in front of and behind a valve by controlling the opening degree of a proportional valve so as to control the pressure in a balloon, generally the pressure is controlled by a single valve, a functional relation is not established between the pressure and other parts of a system, and dynamic balance is difficult to realize. At present, some cryoablators are also used for real-time adjustment according to the pressure condition monitored in real time, continuous detection data are needed in the method, adjustment is delayed, and the pressure in the saccule is easy to be abnormal.
Some embodiments of the present disclosure provide a dynamic balance system for pressure in a balloon of a cryoablation instrument, which establishes a functional relationship among a balloon front-end proportional control valve, a balloon rear-end proportional control valve, and a vacuum pump through theoretical data, estimates a required initial opening of a valve, verifies an adjustment accuracy according to monitoring data during an adjustment process, and continuously corrects the opening of the valve in real time, so that the pressure in the balloon is kept in dynamic balance. The dynamic pressure balance system in the balloon of the cryoablation instrument can improve the accuracy of pressure control and greatly reduce the risk in the cryoablation treatment process.
In some embodiments, during the process of adjusting the valve openings of the balloon front end proportional control valve and the balloon rear end proportional control valve to adjust the pressure, the gas state parameters of the measuring point positions can be detected in real time, and whether the gas state parameters are in a reasonable range or not is analyzed, so that the state of the refrigerant can be monitored, and the situation that the refrigerant is not completely evaporated can be avoided at least.
Fig. 2 is a schematic structural view of a dynamic pressure balancing system within a cryoablator balloon according to some embodiments herein.
As shown in fig. 2, some embodiments of the present disclosure provide a dynamic balancing system for pressure inside a balloon of a cryoablation apparatus, where the dynamic balancing system 200 may include a refrigerant gas pressure tank 210, a liquefaction heat exchanger 220, a catheter 260, and a cryoballoon 230, and after a cryoablation process is started, refrigerant gas from the refrigerant gas pressure tank 210 is re-liquefied by the liquefaction heat exchanger 220, and then is transported into the catheter 260, and then is transported into the cryoballoon 230 by the catheter 260. Further, after the liquefied refrigerant enters the cryoballoon 230, the pressure is rapidly reduced, and at this time, the pressure in the cryoballoon 230 is much lower than the saturated vapor pressure of the liquefied refrigerant, so that the refrigerant is vaporized again, and the heat of the surrounding environment is taken away, thereby achieving the purpose of cryoablation treatment.
In some embodiments, the dynamic balancing system 200 may further include a control unit, a data acquisition unit, and a pressure adjustment unit, the control unit is in communication with the data acquisition unit and the pressure adjustment unit, the data acquisition unit may be configured to acquire relevant parameters during cryoablation treatment, the pressure adjustment unit may be configured to regulate and control the pressure inside the cryoballoon 230, and the control unit may control operating parameters of the pressure adjustment unit during operation according to the relevant parameters acquired by the data acquisition unit. Through the real-time cooperation of the control unit, the data acquisition unit and the pressure regulation unit, the pressure in the freezing saccule 230 can be kept in dynamic balance, so that the curative effect and the stability of the cryoablation treatment process are improved.
In some embodiments, the data acquisition unit may include monitoring components, such as pressure monitoring components, temperature monitoring components, flow monitoring components, and the like, for acquiring cryoablation therapy process-related parameters. Further, monitoring components can be arranged at appropriate station locations as needed to monitor parameters at the respective locations.
In some embodiments, the data acquisition unit may include a plurality of stations that may be used to detect a gas condition at the target location. The number and the position of the plurality of measuring points are not limited in the embodiment of the description, and can be adaptively set according to actual needs.
In some embodiments, the data acquisition unit may further comprise a flow meter 246, and the flow meter 246 may be used to detect the volumetric flow rate of the refrigerant gas. The flow meter 246 can be placed anywhere in the refrigerant gas line since the volumetric flow rate of gas flow is the same anywhere in the same line. In some embodiments, the flow meter 246 may be disposed at the end of the pipeline, i.e., the end from which the gas is discharged. For example only, as shown in fig. 2, a flow meter 246 may be provided at an outlet end of the vacuum pump 253, and may be used to detect a volume flow rate of the refrigerant gas discharged from the vacuum pump 253.
In some embodiments, the pressure adjustment unit may include components for adjusting the pressure inside the cryoballoon 230. In some embodiments, the pressure regulating unit may include a component for regulating the flow rate of refrigerant gas circulating in the line, such as a self-regulating valve or the like. The pressure adjusting unit may include a means for adjusting the flow rate of the refrigerant gas discharge line, for example, a suction pump or the like. In some embodiments, as shown in fig. 2, the pressure regulating unit may include a balloon front end proportional regulating valve 251, a balloon rear end proportional regulating valve 252, and a vacuum pump 253. Further, the balloon front end proportional regulating valve 251 can regulate the flow rate of the refrigerant gas entering the freezing balloon 230 by regulating the flow area thereof; the balloon rear-end proportional control valve 252 can adjust the flow rate of the refrigerant gas discharged out of the freezing balloon 230 by adjusting the flow area thereof. The pressure regulating unit may further include a vacuum pump 253, the frequency of the vacuum pump 253 is fixed when the vacuum pump 253 is actually used, that is, the air suction speed is fixed, and the air suction speed of the vacuum pump 253 can be indirectly controlled by regulating the flow area of the balloon rear end proportional regulating valve 252.
In some embodiments, the control unit may include components for regulating the pressure inside the cryoballoon 230, e.g., a controller that may send control instructions, etc. In some embodiments, the control unit may be a controller disposed within a host (e.g., host 100). In some embodiments, the control unit may include a control screen or display screen for human-computer interaction, which may facilitate input of control instructions.
In some embodiments, the control unit may adjust the internal pressure of the cryoballoon 230 by regulating the operating parameters of the pressure adjustment unit. In some embodiments, the control unit may adjust the flow areas of the balloon front end proportional regulating valve 251 and the balloon rear end proportional regulating valve 252 and the vacuum pumping speed of the vacuum pump 253 in real time based on the gas state and the volume flow data acquired by the data acquisition unit.
As shown in fig. 2, in some embodiments, the plurality of measuring points may include a first measuring point 241, a second measuring point 242, a third measuring point 243, a fourth measuring point 244 and a fifth measuring point 245, and by providing the plurality of measuring points, the gas state of the refrigerant gas flowing through each position of the pipeline can be detected, so as to better control the regulating unit to maintain the pressure inside the freezing balloon 230 in dynamic balance. In some embodiments, the gas conditions detected at each station may include the pressure P and temperature T of the refrigerant gas. In some embodiments, a pressure gauge and a temperature gauge may be installed at each station location for detecting and displaying the pressure P and the temperature T of the refrigerant gas flowing through the target location. Further, the gas state detected at each station position can be transmitted to the control unit in real time.
In some embodiments, as shown in fig. 2, a first measuring point 241 may be provided at the front end of the balloon front end proportional regulating valve 251, and may be used for measuring the gas state (e.g., gas pressure, gas temperature) of the refrigerant gas flowing into the front end of the balloon front end proportional regulating valve 251. In some embodiments, a second measuring point 242 may be provided between the balloon front end proportional regulating valve 251 and the liquefaction heat exchanger 220, and may be used for measuring the gas state of the refrigerant gas in the pipeline after being regulated by the balloon front end proportional regulating valve 251. The gas states of the front end and the rear end of the balloon front end proportional control valve 251 can be detected through the first measuring point 241 and the second measuring point 242, and the required opening degree of the balloon front end proportional control valve 251 can be calculated by combining the detected volume flow, so as to adjust the pressure inside the freezing balloon 230. For the control process of the balloon front end proportional control valve 251, reference may be made to other parts (for example, relevant contents in fig. 3 and fig. 4) in this description, and details are not repeated here.
In some embodiments, a third point 243 may be provided between the cryoballoon 230 and the balloon rear proportional regulating valve 252, which may be used to measure the gas state of the refrigerant gas after being discharged from within the cryoballoon 230. In some embodiments, a fourth point 244 may be provided between balloon rear proportional control valve 252 and vacuum pump 253, and may be used to measure the gas state of the refrigerant gas before vacuum pump 253 (i.e., after balloon rear proportional control valve 252 has been adjusted). The gas states of the front end and the rear end of the balloon rear end proportional control valve 252 can be detected through the third measuring point 243 and the fourth measuring point 244, and the opening degree required by the balloon rear end proportional control valve 252 can be calculated by combining the detected volume flow, so as to adjust the pressure inside the freezing balloon 230. For the control process of the balloon rear-end proportional control valve 252, reference may be made to other parts (for example, relevant contents in fig. 3 and fig. 4) in this description, and details are not repeated here.
In some embodiments, the gas state (e.g., temperature) of the refrigerant gas at the front end of the liquefaction heat exchanger 220 may be detected at the second measurement point 242, the gas state (e.g., temperature) of the refrigerant gas after being discharged from the freezing balloon 230 may be detected at the third measurement point 243, and whether the refrigerant is completely vaporized may be determined by calculating the heat exchange amount, so that the refrigerant inside the freezing balloon 230 may be prevented from being stored in the freezing balloon 230 without being completely vaporized.
In some embodiments, a fifth measurement point 245 may be provided between the vacuum pump 253 and the flow meter 246, and may be used to measure the gas state of the refrigerant gas discharged from the vacuum pump 253. The gas state at the front end and the rear end of the vacuum pump 253 can be detected through the fourth measuring point 244 and the fifth measuring point 245, and the required vacuumizing speed of the vacuum pump 253 can be calculated by combining the detected volume flow so as to adjust the pressure inside the freezing balloon 230.
Fig. 3 is a control logic diagram of a dynamic pressure balancing system within a cryoablator balloon according to some embodiments herein. As shown in fig. 3, in some embodiments, a control flow 300 of a pressure dynamic balancing system within a balloon may include the following steps.
310, after the cryoablation treatment is started, the initial setting value of the opening degree of the balloon front end proportion adjusting valve is A1The initial set value of the opening degree of the balloon rear end proportion adjusting valve is A2(ii) a The desired pressure setting at the cryoballoon site is P0. In some embodiments, the desired set point P for the pressure at the cryoballoon site0May be the bubble point pressure at which the refrigerant vaporizes.
The initial opening setting value of the balloon front end proportion adjusting valve can refer to the initial opening of the balloon front end proportion adjusting valve which starts to operate at the beginning when the cryoablation is started. In some embodiments, the initial opening of the balloon front end proportional regulating valve can be set according to the expected value of the pressure in the freezing balloon, for example, if the expected value of the pressure in the freezing balloon is larger, the initial opening of the balloon front end proportional regulating valve can be set to be larger so as to increase the flow rate of the refrigerant filled into the freezing balloon and enable the pressure in the freezing balloon to be increased rapidly; if the expected value of the pressure in the freezing saccule is smaller, the initial opening of the saccule front end proportion adjusting valve can be set smaller so as to slow down the flow rate of the refrigerant filled into the freezing saccule and avoid over-inflation caused by too fast increase of the pressure in the freezing saccule.
After the cryoablation is carried out for a certain time, the temperature difference between the cryoballoon and the outside is gradually reduced, and the heat exchange amount is correspondingly reduced to achieve phase contrastThe same cooling effect requires an increase in the flow rate of the refrigerant, and therefore, the opening degree of the balloon front end proportional control valve can be increased to increase the refrigerant flow rate, and accordingly, the initial setting value of the balloon front end proportional control valve can be appropriately increased. In some embodiments, the initial setting value a of the balloon front-end proportional control valve may be adjusted based on the accumulated time t for the cryoablator to begin freezing during the course of the cryoablation treatment1By way of example only, A1The specific adjustment method is as follows: a. the1＝A0(1-e ^ (-0.013 t)); wherein A is0The flow area of the balloon front end which is fully opened is proportionally adjusted.
The initial opening setting value of the balloon rear end proportion adjusting valve can refer to the initial opening at which the balloon rear end proportion adjusting valve starts to operate when cryoablation is started. In some embodiments, the initial opening of the balloon rear end proportional regulating valve may be set according to the desired value of the pressure inside the freezing balloon and the initial setting value of the balloon front end proportional regulating valve, for example, if the desired value of the pressure inside the freezing balloon is large and the initial setting value of the balloon front end proportional regulating valve is small, the initial opening of the balloon rear end proportional regulating valve may be set small to reduce the flow rate of the refrigerant discharged out of the freezing balloon to increase the pressure inside the freezing balloon; if the expected value of the pressure in the freezing saccule is small and the initial set value of the saccule front end proportion adjusting valve is large, the initial opening degree of the saccule rear end proportion adjusting valve can be set to be large so as to increase the flow rate of the refrigerant discharged out of the freezing saccule and avoid the pressure in the freezing saccule from exceeding the expected set value.
Step 320, detecting the gas pressure P of the third measuring point in real time in the process of cryoablation treatment3. By monitoring the gas pressure of the refrigerant gas discharged from the cryoballoon, the real-time status of the pressure inside the cryoballoon can be estimated so as to perform pressure regulation in time when the pressure inside the cryoballoon fluctuates. In some embodiments, the gas pressure P may be plotted3The monitoring curve changing along with time can intuitively know the pressure in the freezing saccule at any time.
Step 330, determining the gas pressure P at the third measuring point3Whether or not toGreater than the desired set point P for the pressure of the cryoballoon0. When P is present3<P0During the operation, the opening degree of the balloon front end proportion adjusting valve can be kept at an initial set value A1The opening degree of the balloon rear end proportion adjusting valve can be kept at an initial set value A unchanged2And is not changed.
Step 340, when P is3>P0In time, the real-time opening A of the proportional control valve at the front end of the saccule can be adjusted simultaneously1' real-time opening A of proportional control valve at front end of balloon2' to make the pressure in the freezing saccule in dynamic balance state, to ensure the pressure in the freezing saccule not to exceed the bubble point pressure of the refrigerant, to make the refrigerant in the saccule completely vaporized. About real-time opening degree A1' and real-time opening degree A2The detailed contents of' can be referred to other parts of the present description (for example, the relevant contents of fig. 4), and are not described herein again.
Step 350, based on the first pressure P of the refrigerant gas at the first and second stations1And a second pressure P2A first temperature T1And a second temperature T2First flow velocity w1And a second flow rate w2The functional relationship a ═ f (P, T, w) is established.
And step 360, calculating the real-time opening A of the balloon front end proportional control valve according to the functional relation A-f (P, T, w)1’。
Step 370, based on the third pressure P of the refrigerant gas at the third and fourth measurement points3And a fourth pressure P4A third temperature T3And a fourth temperature T4Third flow velocity w3And a fourth flow rate w4The functional relationship a ═ f (P, T, w) is established.
Step 380, calculating the real-time opening A of the balloon front end proportional control valve according to the functional relation A ═ f (P, T, w)2’。
In some embodiments, the functional relationship a ═ f (P, T, w) can be established by bernoulli's equation for compressible fluids, flow equations, and helmholtz free energy state equation. Specifically, the real-time opening degree of the valve (a in the formula) can be calculated by the following equation system, and the bernoulli equation is shown as follows:
Figure BDA0003403585210000071
the flow formula is shown as follows:
Figure BDA0003403585210000081
the helmholtz free energy state equation is shown as follows:
Figure BDA0003403585210000082
Figure BDA0003403585210000083
Figure BDA0003403585210000084
in the above formula: gamma ═ CP/CVV is the volume flow measured by the flowmeter, and rho is the gas density at the target position; q is the mass flow of the refrigerant gas in the conduit, d2R is the ideal gas constant for the diameter of the conduit at the second measurement point.
The method comprises the steps of arranging a first measuring point and a second measuring point at the front end and the rear end of a balloon front-end proportional control valve, arranging a third measuring point and a fourth measuring point at the front end and the rear end of the balloon rear-end proportional control valve, monitoring the gas state of refrigerant gas at each measuring point, and calculating the real-time opening degree of the balloon front-end proportional control valve and the balloon rear-end proportional control valve by establishing a functional relation based on the gas state monitored in real time. The air flow conditions of all positions of the whole system are comprehensively considered, the balloon front end proportion adjusting valve and the balloon rear end proportion adjusting valve are adjusted and controlled simultaneously, the flow velocity of refrigerant gas is accurately controlled, the pressure in the freezing balloon is kept in dynamic balance, no adjustment delay exists, and the balloon is always kept in a full state. Furthermore, in the treatment process, the state of the refrigerant gas in the freezing saccule can be monitored through the gas state detected by the third measuring point, so that whether pressure adjustment is needed or not can be judged, and the situation that the refrigerant in the saccule is not completely evaporated can be avoided.
FIG. 4 is a graph showing the results of the present specification on nitrous oxide (N)2O) is a control logic diagram of a dynamic balance system of the pressure in the balloon of the cryoablation instrument when the refrigerant is used. As shown in FIG. 4, the refrigerant used in the pressure dynamic balance system in the balloon of the cryoablation apparatus is N2O, the control flow 400 may include the following steps.
Step 410, after the cryoablation treatment is started, the initial setting value of the opening degree of the balloon front end proportion adjusting valve is A1＝A0(1-e ^ (-0.013t)), and the initial set value of the opening degree of the balloon rear-end proportional control valve is A2(ii) a The desired pressure setting at the cryoballoon site is P0. Specifically, more details can be found in the description of step 310, and are not described herein.
Step 420, detecting the gas pressure P of the third measuring point in real time in the process of cryoablation treatment3. In some embodiments, a pressure monitoring component (e.g., a pressure gauge) can be installed at the third measuring point, and the pressure monitoring component is in communication connection with the control unit to detect the gas pressure P in real time3And feeding back to the control unit.
Step 430, judging the gas pressure P of the third measuring point3Whether or not it is greater than the desired set value P of the pressure of the cryoballoon0. In some embodiments, as shown in FIG. 4, with nitrous oxide (N)2O, commonly known as laughing gas), the desired set point for the pressure of the cryoballoon may be P00.16 MPa. When P is present3<At 0.16MPa, the opening degree of the balloon front end proportional control valve can be A1＝A0(1-e ^ (-0.013t)) was used for the regulation.
Step 440, when P is3>When the pressure is 0.16MPa, the real-time opening A of the proportional control valve at the front end of the saccule can be adjusted1' simultaneously starting the balloon rear end proportional control valve, the balloon rear end proportional control valve is opened by an initial opening degree A2Operation is initiated to place the pressure within the cryoballoon in dynamic equilibrium.
Step 451, after the proportional control valve at the front end of the balloon starts to be adjusted, detecting the gas state of the refrigerant gas at the first measuring point and the second measuring point, including the first pressure P1And a second pressure P2A first temperature T1And a second temperature T2(ii) a Through the helmholtz free energy state equation, gas parameters of the refrigerant gas at the first measuring point and the second measuring point can be calculated, and the gas parameters can comprise gas density rho, volume specific heat capacity Cv and pressure specific heat capacity Cp.
Specifically, the helmholtz free energy state equation is shown as follows:
Figure BDA0003403585210000091
Figure BDA0003403585210000092
Figure BDA0003403585210000093
in the above formula: r is an ideal gas constant, and R is an ideal gas constant,
Figure BDA0003403585210000094
is the second derivative of the Helmholtz free energy residual function with respect to delta and tau, r is the angular scale of the residual function, tau is the specific temperature, and tau is Tc/T，TcIs the gas critical temperature, T is the state point temperature for the gas to calculate, δ is the specific density, δ is ρ/ρcρ is the density of state points of the gas used for calculation, ρcAlpha is the helmholtz free energy for the critical density of the gas. a (ρ, T) ═ a0(F,T)+ar(ρ, T), a (ρ, T) is Helmholtz free energy, a0(F, T) is the contribution of the ideal gas to the Helmholtz free energy, ar(ρ, T) is the residual Helmholtz energy produced by intermolecular forces.
Step 452, calculating a second flow rate w at the second measurement point using the volumetric flow2The volumetric flow rate may be detected by a flow meter (e.g., flow meter 246).
Specifically, the flow rate formula is shown as follows:
Figure BDA0003403585210000095
wherein q is mass flow, V is volume flow, ρ5Is the density, p, of the refrigerant gas at the fifth measurement point2Is the density of the refrigerant gas at the second measurement point, d2Is the diameter of the catheter at the second station.
By the equation
Figure BDA0003403585210000096
A second flow rate w at the second measurement point can be calculated2。
At step 453, the calculated flow rate w of step 452 is used2By means of the compressible Bernoulli equation, a first flow velocity w at the first measurement point can be calculated1。
Specifically, the bernoulli equation for compressible fluids is shown below:
Figure BDA0003403585210000101
wherein γ is CP/CV，ρ1Is the first density, ρ, of the refrigerant gas at the first measurement point2Is the second density, P, of the refrigerant gas at the second measurement point1Is a first pressure, P, of the refrigerant gas at a first point2Is a second pressure of the refrigerant gas at the second point.
Step 454, utilizing the flow rate w calculated in step 4531By the formula q ═ V ρ5＝w1ρ1A, calculating to obtain a flow area A, and taking A as the real-time opening A of the balloon front end proportional control valve1’。
Step 461, begin adjusting the ballAfter the proportion regulating valve at the rear end of the bag, detecting the third pressure P of the refrigerant gas at the third measuring point and the fourth measuring point in real time3And a fourth pressure P4A third temperature T3And a fourth temperature T4. Gas parameters of the refrigerant gas at the third measuring point and the fourth measuring point can be calculated through a Helmholtz free energy state equation: gas density rho, volumetric specific heat capacity Cv, pressure specific heat capacity CP. The specific calculation process can be referred to the description of step 251.
Step 462, calculating the flow velocity w at the fourth measurement point using the volumetric flow4The volumetric flow rate may be detected by a flow meter (e.g., flow meter 246).
Specifically, the flow rate formula is shown as follows:
Figure BDA0003403585210000102
wherein q is mass flow, V is volume flow, ρ5Is the density, p, of the refrigerant gas at the fifth measurement point4Is the density of the refrigerant gas at the fourth measurement point, d4Is the diameter of the catheter at the fourth station.
By the equation
Figure BDA0003403585210000103
A fourth flow rate w at the fourth measurement point can be calculated4。
Step 463, using the flow rate w calculated in step 4624By the compressible Bernoulli equation, the flow velocity w at the third measurement point can be calculated3。
Specifically, the bernoulli equation for compressible fluids is shown below:
Figure BDA0003403585210000104
wherein γ is CP/CV，ρ3Is the third density, p, of the refrigerant gas at the third measurement point4Is the fourth density of the refrigerant gas at the fourth measurement point，P3Is the third pressure, P, of the refrigerant gas at the third point4Is the fourth pressure of the refrigerant gas at the fourth point.
Step 464, utilizing the calculated flow rate w of step 4633By the formula q ═ V ρ5＝w3ρ3A, calculating to obtain a flow area A, and taking A as the real-time opening A of the balloon front end proportional control valve2’。
In some embodiments, step 470 may be further included, and the real-time opening degree a of the valve is proportionally adjusted at the front end of the balloon1' real-time opening A of proportional control valve at front end of balloon2In the adjusting process of' the data acquisition unit can detect the gas state of the measuring point position in real time and transmit the gas state to the control unit to analyze whether the detected gas state parameter (for example, the pressure P) is in a reasonable range. If the real-time opening degree of the proportional control valve is not in a reasonable range (for example, a pressure range), the real-time opening degree A of the proportional control valve at the front end of the ball bag1' real-time opening A of proportional control valve at front end of balloon2' readjust or send an alarm signal. In some embodiments, a second pressure P of the refrigerant gas at the second point may be monitored2Judgment of P2Whether within a preset pressure range. For example only, as shown in FIG. 4, a second pressure P of the refrigerant gas at the second measurement point may be set2Reasonable range of (4 MPa > P)2Is more than 3.6 MPa. In some embodiments, when the second pressure P of the refrigerant gas at the second point2Within a reasonable range (i.e., 4MPa > P is satisfied)2> 3.6MPa), the system can be operated according to the current operating parameters. In some embodiments, when the second pressure P of the refrigerant gas at the second point2Out of reasonable range (i.e., P)2> 4MPa, or P2Less than 3.6MPa), and judging whether the balloon front end proportion adjusting valve is in a fully open state at present. For example, if the second pressure P2Out of the reasonable range, the balloon front proportional regulating valve is not fully opened (i.e. A)1’＜A0) The balloon front end proportional control valve and the balloon rear end proportional control valve can be continuously adjusted until the second pressure P2Satisfying a reasonable range. For another example, ifTwo pressures P2Out of the reasonable range, the balloon front proportional regulating valve is fully opened (i.e. A)1’＝A0) And immediately stopping the cryoablation treatment and sending an alarm prompt.
It should be noted that the above description related to the flow 400 is only for illustration and description, and does not limit the applicable scope of the present specification. Various modifications and changes to flow 400 will be apparent to those skilled in the art in light of this description. However, such modifications and variations are intended to be within the scope of the present description.
The beneficial effects that may be brought by the embodiments of the present application include, but are not limited to: 1) the system is provided with a plurality of measuring points, the gas state of the refrigerant gas at each measuring point is monitored, the real-time opening degree of the valve is calculated based on the function relationship established by the gas state monitored in real time, and meanwhile, the proportion regulating valve at the front end of the balloon and the proportion regulating valve at the rear end of the balloon are regulated and controlled to accurately control the flow rate of the refrigerant gas, so that the pressure in the freezing balloon is kept in dynamic balance, no regulation delay exists, and the balloon is kept in a full state all the time; 2) in the treatment process, the gas state detected by the third measuring point can monitor the condition of the refrigerant gas in the freezing saccule, so that whether pressure adjustment is needed or not can be judged, and the situation that the refrigerant in the freezing saccule is not completely evaporated can be avoided; 3) the initial opening degree of the balloon front end proportion adjusting valve can be adjusted according to A along with the progress of treatment1＝A0(1-e ^ (-0.013t)) is adjusted, the temperature difference change between the freezing saccule and the outside is comprehensively considered, the flow rate of the refrigerant can be adjusted in time, and the situation that the refrigerant in the freezing saccule cannot be completely evaporated due to insufficient heat is avoided; 4) monitoring a second pressure P of the refrigerant gas at the second point during the treatment2Judgment of P2Whether in the pressure range of predetermineeing, can in time readjust the real-time aperture of sacculus front end proportional control valve and the real-time aperture of sacculus front end proportional control valve, can in time report to the police the suggestion when pressure does not satisfy the scope and sacculus front end proportional control valve has fully opened.
It is to be noted that different embodiments may produce different advantages, and in different embodiments, any one or combination of the above advantages may be produced, or any other advantages may be obtained.
Having thus described the basic concept, it will be apparent to those skilled in the art that the foregoing detailed disclosure is to be regarded as illustrative only and not as limiting the present specification. Various modifications, improvements and adaptations to the present description may occur to those skilled in the art, although not explicitly described herein. Such modifications, improvements and adaptations are proposed in the present specification and thus fall within the spirit and scope of the exemplary embodiments of the present specification.
Also, the description uses specific words to describe embodiments of the description. Reference throughout this specification to "one embodiment," "an embodiment," and/or "some embodiments" means that a particular feature, structure, or characteristic described in connection with at least one embodiment of the specification is included. Therefore, it is emphasized and should be appreciated that two or more references to "an embodiment" or "one embodiment" or "an alternative embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, some features, structures, or characteristics of one or more embodiments of the specification may be combined as appropriate.
Additionally, the order in which the elements and sequences of the process are recited in the specification, the use of alphanumeric characters, or other designations, is not intended to limit the order in which the processes and methods of the specification occur, unless otherwise specified in the claims. While various presently contemplated embodiments of the invention have been discussed in the foregoing disclosure by way of example, it is to be understood that such detail is solely for that purpose and that the appended claims are not limited to the disclosed embodiments, but, on the contrary, are intended to cover all modifications and equivalent arrangements that are within the spirit and scope of the embodiments herein. For example, although the system components described above may be implemented by hardware devices, they may also be implemented by software-only solutions, such as installing the described system on an existing server or mobile device.
Similarly, it should be noted that in the preceding description of embodiments of the present specification, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure aiding in the understanding of one or more of the embodiments. This method of disclosure, however, is not intended to imply that more features than are expressly recited in a claim. Indeed, the embodiments may be characterized as having less than all of the features of a single embodiment disclosed above.
Numerals describing the number of components, attributes, etc. are used in some embodiments, it being understood that such numerals used in the description of the embodiments are modified in some instances by the use of the modifier "about", "approximately" or "substantially". Unless otherwise indicated, "about", "approximately" or "substantially" indicates that the number allows a variation of ± 20%. Accordingly, in some embodiments, the numerical parameters used in the specification and claims are approximations that may vary depending upon the desired properties of the individual embodiments. In some embodiments, the numerical parameter should take into account the specified significant digits and employ a general digit preserving approach. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the range are approximations, in the specific examples, such numerical values are set forth as precisely as possible within the scope of the application.
For each patent, patent application publication, and other material, such as articles, books, specifications, publications, documents, etc., cited in this specification, the entire contents of each are hereby incorporated by reference into this specification. Except where the application history document does not conform to or conflict with the contents of the present specification, it is to be understood that the application history document, as used herein in the present specification or appended claims, is intended to define the broadest scope of the present specification (whether presently or later in the specification) rather than the broadest scope of the present specification. It is to be understood that the descriptions, definitions and/or uses of terms in the accompanying materials of this specification shall control if they are inconsistent or contrary to the descriptions and/or uses of terms in this specification.
Finally, it should be understood that the embodiments described herein are merely illustrative of the principles of the embodiments of the present disclosure. Other variations are also possible within the scope of the present description. Thus, by way of example, and not limitation, alternative configurations of the embodiments of the specification can be considered consistent with the teachings of the specification. Accordingly, the embodiments of the present description are not limited to only those embodiments explicitly described and depicted herein.

Claims (11)

1. The utility model provides a dynamic balance system in cryoablation appearance sacculus, includes refrigerant gas overhead tank, liquefaction heat exchanger, pipe, freezing sacculus, its characterized in that: the device also comprises a control unit, a data acquisition unit and a pressure regulation unit; the control unit is in communication connection with the data acquisition unit and the pressure regulation unit;
the data acquisition unit comprises a plurality of measuring points and a flowmeter; the plurality of measuring points are used for detecting the gas state of the target position; the flow meter is used for detecting the volume flow of the refrigerant gas;
the pressure adjusting unit comprises a balloon front end proportion adjusting valve, a balloon rear end proportion adjusting valve and a vacuum pump;
the control unit adjusts the flow areas of the balloon front end proportion adjusting valve and the balloon rear end proportion adjusting valve and the vacuumizing speed of the vacuum pump in real time based on the gas state and the volume flow data acquired by the data acquisition unit.
2. The system of claim 1, wherein the plurality of stations comprises a first station, a second station, a third station, a fourth station, and a fifth station;
the first measuring point is arranged at the front end of the balloon front end proportion adjusting valve and is used for measuring the gas state in front of the balloon front end proportion adjusting valve;
the second measuring point is arranged between the balloon front end proportion adjusting valve and the liquefaction heat exchanger and is used for measuring the gas state adjusted by the balloon front end proportion adjusting valve;
the third measuring point is arranged between the freezing saccule and the saccule rear end proportion regulating valve and is used for measuring the gas state of the gas discharged from the freezing saccule;
the fourth measuring point is arranged between the balloon rear end proportion adjusting valve and the vacuum pump and is used for measuring the gas state in front of the vacuum pump;
and the fifth measuring point is arranged between the vacuum pump and the flowmeter and is used for measuring the gas state at the front end of the flowmeter.
3. The system of claim 2, wherein the gas state comprises pressure and temperature of gas in the catheter.
4. The system of claim 3, wherein the initial setting value of the opening of the proportional control valve at the front end of the balloon is A1The initial opening setting value of the balloon rear end proportional control valve is A2(ii) a The desired pressure setting value of the freezing saccule part is P0；
After the freezing saccule starts to perform freezing work, the gas pressure measured by the third measuring point is the third pressure P3When P is3<P0During the operation, the opening degree of the balloon front end proportional control valve is kept at an initial set value A1The opening degree of the balloon rear end proportion adjusting valve is kept at an initial set value A unchanged2The change is not changed;
when P is present5>P0Simultaneously adjusting the real-time opening A of the proportional control valve at the front end of the balloon1' real-time opening A of proportional control valve at front end of balloon2' to dynamically balance the pressure in the cryoballoon.
5. The system of claim 4, wherein the first pressure P is based on a refrigerant gas at the first and second points1And a second pressure P2A first temperature T1And a second temperature T2First flow velocity w1And a second flow rate w2And calculating the real-time opening A of the balloon front end proportional control valve according to the functional relation A-f (P, T, w)1'; based on refrigerant gas at third and fourth stationsThird pressure P3And a fourth pressure P4A third temperature T3And a fourth temperature T4Third flow velocity w3And a third flow rate w4And calculating the real-time opening A of the balloon front end proportional control valve according to the functional relation A-f (P, T, w)2’。
6. The system of claim 5, wherein the functional relationship A ═ f (P, T, w) is established by Bernoulli's equation for compressible fluids, flow equations, and Helmholtz's free energy state equation.
7. The system of claim 5, wherein the Bernoulli equation is expressed by the following equation:
Figure FDA0003403585200000021
in the above formula: gamma ═ CP/CVCv is the volume specific heat capacity, Cp is the pressure specific heat capacity; ρ is the gas density at the target location; w is the gas flow rate at the target location.
8. The system of claim 7, wherein the flow rate is expressed by the following equation:
Figure FDA0003403585200000022
in the above formula: v is the volume flow measured by the flowmeter; ρ is the gas density at the target location; q is the mass flow of refrigerant gas in the conduit; d2Is the diameter of the catheter at the second station.
9. The system of claim 8, wherein the helmholtz free energy state equation is expressed as follows:
Figure FDA0003403585200000023
Figure FDA0003403585200000024
Figure FDA0003403585200000031
in the above formula: r is an ideal gas constant; p is the gas pressure at the target location; t is the gas temperature at the target location.
10. The system of claim 4, wherein the real-time opening A of the proportional control valve at the front end of the balloon is adjusted1' real-time opening A of proportional control valve at front end of balloon2In the adjusting process of' the method, the data acquisition unit detects the gas state of the target position in real time and transmits the gas state to the control unit to analyze whether the gas state is in a reasonable range; if the front end of the saccule is not in a reasonable range, the real-time opening A of the proportional control valve at the front end of the saccule1' real-time opening A of proportional control valve at front end of balloon2' readjust or send an alarm signal.
11. The system of claim 4, wherein the initial setting A is adjusted based on the cumulative time t for the cryoablator to begin freezing1The specific operation mode is as follows: a. the1＝A0(1-e^(-0.013t))；
Wherein A is0The flow area of the balloon front end which is fully opened is proportionally adjusted.
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