CN117159121A - Cryoablation system and method with adjustable balloon size - Google Patents
Cryoablation system and method with adjustable balloon size Download PDFInfo
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Abstract
The application provides a cryoablation system and a cryoablation method with an adjustable balloon size, which belong to the technical field of cryotherapy, wherein the system specifically comprises an adjustable-size balloon, a tube body part and a control part which are sequentially connected, the control part comprises an inflation pipeline and a balloon flow pressure control pipeline, the inflation pipeline is connected with the balloon through the tube body part, the inflation pipeline controls the size of the balloon by inflating the balloon to a target pressure corresponding to the size of the balloon, the balloon flow pressure control pipeline is connected with the balloon through the tube body part, and the balloon flow pressure control pipeline is used for controlling the gas flow and the pressure in the balloon in the ablation process. By the treatment scheme, the safety, effectiveness and applicability of the cryoablation treatment for atrial fibrillation are improved.
Description
Technical Field
The application relates to the technical field of cryocryotherapy, in particular to a cryoablation system and method with an adjustable balloon size.
Background
At present, minimally invasive intervention technology for treating diseases such as arrhythmia is becoming a main means for treating the diseases, atrial fibrillation (atrial fibrillation) is one of the most common clinical tachyarrhythmias, the total prevalence of the atrial fibrillation in China is about 0.7%, and the prevalence is increased year by year along with the aging of population. In terms of atrial fibrillation treatment, the curative effect of catheter ablation treatment on atrial fibrillation is well known, and Pulmonary Vein Isolation (PVI) is a foundation stone for catheter ablation treatment on atrial fibrillation. Cryoballoon ablation (cryoballoon ablation, CBA) is a new ablation method that has emerged in recent years and has become one of the standard methods for achieving PVI. Several studies have demonstrated that CBA has good safety and effectiveness in treating atrial fibrillation, and has the advantages of short learning curve, fewer serious complications, low readmission rate, and the like.
The mechanism of cryoablation is to cause target myocardial cell necrosis by low temperature caused by cryoenergy, thereby achieving the therapeutic effect. The main factors determining the cryoablation effect are mentioned in the national expert consensus 2020 for atrial fibrillation ablation via cryoballoon catheters, including "contact level and local blood flow: there is no damage without contact and local blood flow is an important factor affecting tissue temperature, and the expert consensus also mentions the cryoballoon system preparation precautions — "cryoballoon catheter diameter selection", balloon size and pulmonary vein abutment and occlusion are critical. The balloon size is therefore closely related to the effectiveness and safety of cryotherapy.
In the prior art, the only atrial fibrillation cryoablation system on the domestic market at present is Cryoablation System developed by Medtronic corporation in America, and the matched consumable balloon catheter (Cryoablation Catheter) has 2 size specifications of 23mm and 28mm respectively. Generally, a human body has 4 pulmonary veins, and each pulmonary vein is ablated for about 1 to 2 times; meanwhile, due to the fact that the shape, thickness, branches, whether the pulmonary veins of the human body are co-dried, malformation and the like are very complex, 2 balloon sizes are difficult to adapt to the pulmonary veins with wide anatomical forms. For a particular patient, if there is both a pulmonary vein of greater than conventional diameter and a relatively narrow pulmonary vein, then the physician needs to use two balloon catheters simultaneously for ablation, which increases the handling of the replacement balloon catheter during surgery, carries a risk of use, and also increases the cost of treatment for the patient.
In view of this, there is a need to develop a cryoablation system with balloon size adjustment to improve the safety, effectiveness and applicability of cryoablation therapy for atrial fibrillation.
Disclosure of Invention
In view of the above, the embodiment of the application provides a cryoablation system and a cryoablation method with adjustable balloon size, which can adjust the balloon size, and the system correspondingly controls the balloon size and the output of refrigeration energy according to preset parameters during ablation, thereby effectively improving the safety, the effectiveness and the adaptability of treating atrial fibrillation.
In a first aspect, an embodiment of the present application provides a cryoablation system with an adjustable balloon size, including an adjustable balloon, a tube portion, and a control member connected in sequence, where the control member includes an inflation line and a balloon flow pressure control line, the inflation line is connected to the balloon through the tube portion, the inflation line controls the size of the balloon by inflating the balloon to a target pressure corresponding to the size of the balloon, the balloon flow pressure control line is connected to the balloon through the tube portion, and the balloon flow pressure control line is used to control a gas flow and a pressure in the balloon during an ablation process.
According to a specific implementation manner of the embodiment of the application, the air charging pipeline comprises an air source, a first valve, an air storage tank, a third valve and a flow restrictor which are sequentially connected, and the flow restrictor is connected with the pipe body part; the balloon flow pressure control pipeline comprises a front proportional valve, a first pressure sensor, a heat exchanger, an air inlet of the pipe body part, an air outlet of the pipe body part, a rear proportional valve, a vacuum pump and a mass flowmeter which are connected in sequence, wherein the front proportional valve is connected with the air source; in the ablation process, the control of the air inlet pressure by the front proportional valve realizes the flow closed-loop control of the balloon, and the pressure closed-loop control of the balloon is realized by the rear proportional valve.
According to a specific implementation manner of the embodiment of the application, a second pressure sensor is arranged on the air storage tank, a second valve is arranged between the first valve and the air storage tank, and the second valve is connected with the exhaust gas recovery assembly.
According to a specific implementation manner of the embodiment of the application, a filter for filtering impurities is arranged at the air outlet of the air source.
According to a specific implementation manner of the embodiment of the application, a pressure reducing valve is arranged between the air source and the air storage tank.
According to a specific implementation manner of the embodiment of the application, the system further comprises a graphic interaction platform, the graphic interaction platform is in communication connection with the control component, and the control component and the balloon are visually displayed through the graphic interaction platform.
According to a specific implementation of an embodiment of the application, the pipe body part is connected to the control part by means of a coaxial fluid connection pipe and a connection cable.
According to a specific implementation manner of the embodiment of the application, a temperature sensor and a third pressure sensor are arranged in the balloon.
In a second aspect, a cryoablation method with adjustable balloon size, using a cryoablation system with adjustable balloon size according to any of the embodiments of the first aspect, the method comprising:
acquiring a set size of the balloon;
determining a target pressure and a target flow of the balloon according to the set size;
inflating the balloon to the target pressure by utilizing the inflation pipeline to enable the balloon to reach the set size and plugging;
and starting an ablation process, and monitoring and controlling the flow and the pressure of the balloon in real time through the balloon flow pressure control pipeline so that the pressure and the flow of the balloon respectively reach the target pressure and the target flow.
According to a specific implementation of an embodiment of the application, the balloon pressure when inflated is the same as the pressure when the balloon is ablated, and/or,
the pressure in the post-balloon ablation re-warming stage is the same as the pressure in the balloon ablation.
Advantageous effects
According to the cryoablation system with the adjustable balloon size, due to the fact that the size of the balloon is adjustable, proper sizes can be selected for pulmonary veins of different structures, better adhesion is achieved, more effective damage is formed, and safety and effectiveness of the cryoballoon ablation system in treating atrial fibrillation are improved.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are needed in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present application, and that other drawings can be obtained according to these drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic illustration of a balloon-size adjustable cryoablation system in accordance with an embodiment of the application;
FIG. 2 is a piping connection diagram of a balloon-size-adjustable cryoablation system according to an embodiment of the application;
FIG. 3 is a schematic diagram of a balloon flow pressure control circuit according to an embodiment of the present application;
fig. 4 is a schematic diagram of closed-loop control of the flow of a balloon according to an embodiment of the present application.
FIG. 5 is a schematic diagram of a graphical interaction platform according to an embodiment of the application;
FIG. 6 is a flow chart of a balloon-size adjustable cryoablation method according to one embodiment of the application;
FIG. 7 is a graph of pressure within a balloon versus outer diameter of the balloon according to an embodiment of the present application;
FIG. 8 is a graph of balloon outer diameter versus ablation flow in accordance with an embodiment of the present application;
FIG. 9 is a graph of ablation pressure versus time for different balloon sizes according to an embodiment of the application;
fig. 10 is a graph of ablation flow versus time for different balloon sizes according to an embodiment of the present application.
In the figure: 1. a system host; 2. a graphic interaction platform; 3. a balloon; 4. a tube body portion; 5. a handle.
Detailed Description
Embodiments of the present application will be described in detail below with reference to the accompanying drawings.
Other advantages and effects of the present application will become apparent to those skilled in the art from the following disclosure, which describes the embodiments of the present application with reference to specific examples. It will be apparent that the described embodiments are only some, but not all, embodiments of the application. The application may be practiced or carried out in other embodiments that depart from the specific details, and the details of the present description may be modified or varied from the spirit and scope of the present application. It should be noted that the following embodiments and features in the embodiments may be combined with each other without conflict. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.
It is noted that various aspects of the embodiments are described below within the scope of the following claims. It should be apparent that the aspects described herein may be embodied in a wide variety of forms and that any specific structure and/or function described herein is merely illustrative. Based on the present disclosure, one skilled in the art will appreciate that one aspect described herein may be implemented independently of any other aspect, and that two or more of these aspects may be combined in various ways. For example, an apparatus may be implemented and/or a method practiced using any number of the aspects set forth herein. In addition, such apparatus may be implemented and/or such methods practiced using other structure and/or functionality in addition to one or more of the aspects set forth herein.
It should also be noted that the illustrations provided in the following embodiments merely illustrate the basic concept of the present application by way of illustration, and only the components related to the present application are shown in the drawings and are not drawn according to the number, shape and size of the components in actual implementation, and the form, number and proportion of the components in actual implementation may be arbitrarily changed, and the layout of the components may be more complicated.
In addition, in the following description, specific details are provided in order to provide a thorough understanding of the examples. However, it will be understood by those skilled in the art that the aspects may be practiced without these specific details.
In a first aspect, embodiments of the present application provide a cryoablation system with an adjustable balloon size, described in detail below with reference to fig. 1-5.
Referring to fig. 1, the cryoablation system with adjustable balloon size in this embodiment includes a balloon 3 with adjustable size, a tube portion 4, and a control member connected in sequence, the control member including an inflation line connected with the balloon 3 through the tube portion 4, the inflation line controlling the size of the balloon 3 by inflating the balloon 3 to a target pressure corresponding to the size of the balloon 3, and a balloon flow pressure control line connected with the balloon 3 through the tube portion 4, the balloon flow pressure control line being used for controlling the flow and pressure of gas in the balloon 3 during ablation.
In the implementation, one end of the tube body part 4 is connected with the balloon 3, the other end of the tube body part 4 is connected with the handle 5, the handle 5 is connected with the control part through the coaxial fluid connecting pipe and the connecting cable, the balloon 3, the tube body part 4 and the handle 5 form a cryoablation balloon catheter, and when the implementation is carried out by an operator, the operator holds the handle 5 to operate.
Specifically, the control component is arranged in the system host 1, the system host 1 further comprises a graphic interaction platform 2, the graphic interaction platform 2 is in communication connection with the control component, and the control component and the balloon 3 are visually displayed through the graphic interaction platform 2. The graphic interaction platform 2 is composed of a computer, a touch screen display and a software interaction interface, the software interaction interface of the graphic interaction platform 2 is shown in fig. 5, a user sets and operates by touching the touch screen display, and meanwhile, the display interface displays the state of the balloon 3 and various system parameters in the operation process in real time, such as the temperature and curve in the balloon 3, the ablation time, the ablation flow, the balloon pressure, the state of a host gas cylinder and the like. In this embodiment, the computer is a single-board computer, and the implementation is not limited to the single-board computer, and may be implemented by selecting an industrial personal computer.
In one embodiment, the user may set the balloon size via a software interaction interface (see fig. 5), default balloon size 28mm: the ablation mode is the same as the prior art (the balloon 3 with the size of 28mm is selected for ablation), and the inflation and the ablation are carried out with the size of 28mm. Clicking the "Σ" "≡key beside the" 28mm "icon at the lower left corner of the software interactive interface, the current balloon size can be adjusted and set," +.gtoreq.s. for decreasing the balloon size, "+.gtoreq.s. for increasing the balloon size. The balloon size defaults to 28mm, the settable range is 23 mm-35 mm, and the interval is 1mm; the setting range and interval can have different design range and adjusting fineness. The balloon size can be adjusted in various ways, and the balloon size is not limited to the touch screen design in the embodiment, and can be realized by a physical knob, and the implementation in the embodiment is only taken as an example.
In one embodiment, referring to fig. 2, the inflation line comprises a gas source, a first valve SV1, a gas reservoir, a third valve SV3 and a restrictor connected in sequence, the restrictor being connected to the body portion 4; the balloon flow pressure control pipeline comprises a front proportional valve, a first pressure sensor P1, a heat exchanger, an air inlet of the pipe body part 4, an air outlet of the pipe body part 4, a rear proportional valve, a vacuum pump and a mass flowmeter which are connected in sequence, wherein the front proportional valve is connected with the air source; in the ablation process, the flow closed-loop control of the balloon 3 is realized through the direct control of the front proportional valve on the air inlet pressure, and the pressure closed-loop control of the balloon 3 is realized through the rear proportional valve.
In the use process of a user, firstly preparing a system host 1 according to an operation instruction of the system host 1 of the cryoablation system, connecting the system host 1 of the cryoablation system with a handle 5 through a coaxial fluid connecting pipe and a connecting cable, placing a balloon 3 into a left atrium according to an operation procedure, setting the balloon size in a graphical interactive interface based on the size and the anatomical form of an ablation part, selecting a proper balloon size for inflating, positioning and blocking a pulmonary vein, then performing cryoablation, recording TTI (Time To Isolation, time from beginning of cryoablation to electrical isolation of the pulmonary vein), and paying attention to temperature curve and graphical interactive interface information in the balloon 3 until the ablation is finished; and ablating the rest pulmonary veins according to the same operation sequence, and completing the whole operation flow.
Specifically, the sensor for monitoring each important parameter in the ablation process comprises: the system comprises a first pressure sensor P1 for monitoring air intake, a second pressure sensor P2 arranged on an air storage tank, a temperature sensor T and a third pressure sensor P3 arranged in a balloon 3, a refrigerant mass flowmeter (Flow Meter) and the like, wherein signal acquisition, conversion processing and logic control of the sensors are realized through a PCBA (Printed Circuit Board Assembly) control board, and embedded software is contained in a control board microprocessor chip for logic control. The PCBA control mode has the advantages of large expansibility, relatively low cost and the like. In addition, the system can also adopt a PLC (Programmable Logic Controller ) to collect the signals of each sensor and perform conversion processing and logic control.
In one embodiment, a second pressure sensor P2 is disposed on the air storage tank, a second valve SV2 is further disposed between the first valve SV1 and the air storage tank, and the second valve SV2 is connected to the exhaust gas recovery assembly. That is, the second valve SV2 is located between the gas tank and the exhaust gas recovery unit, the second pressure sensor P2 is configured to monitor the pressure in the gas tank, and when the second pressure sensor P2 detects that the pressure is too high, the second valve SV2 is opened to discharge the excessive gas in the gas tank from the second valve SV2, and the pressure is reduced by slightly releasing the gas.
In one embodiment, a filter for filtering impurities is arranged at the air outlet of the air source and is used for filtering impurities in the air bottle.
In one embodiment, a pressure reducing valve is arranged between the air source and the air storage tank, and the high-pressure air source (about 700-800 PSI) can be reduced and stabilized to a proper pressure range (< 100 PSI) in advance through the pressure reducing valve, so that the safety during inflation is improved.
Specifically, the inflation gas source used by the system of the application is gaseous N at normal temperature 2 O, the structure of the charging pipeline is shown in FIG. 2: the inflation path of the system is N 2 O-cylinder-filter-pressure-reducing valve-first valve (solenoid valve SV 1) -gas reservoir-third valve (solenoid valve SV 3) -restrictor-coaxial fluid connection-pipe body portion 4. The system inflation path is designed with a high-pressure precise filter for filtering impurities in the gas cylinder, so that the problem of blockage of a pipeline or a balloon nozzle caused by the problem of gas purity is avoided; the inflation path is designed with a pressure reducing valve, so that a high-pressure air source (about 700-800 PSI) is reduced and stabilized to a proper pressure range (< 100 PSI) in advance, and the safety during inflation is improved; the volume design of the small air storage tank depends on the pressure range of the air required to be inflated by the balloon 3, and the system is provided with a second pressure sensor P2, wherein the second pressure sensor P2 is used for monitoring and controlling the pressure change of the air storage tank; a third valve (SV 3) and a restrictor (restrictor valve) are arranged at the downstream of the small air storage tank, wherein the SV3 is used for controlling the inflation passage of the balloon 3, and the restrictor (restrictor valve) is beneficial to the inflation smoothness of the balloon 3.
Inflation method of cryoablation system: before the balloon 3 is inflated, the system opens a first valve SV1 to pre-fill the air storage tank to a certain pressure range, the pressure of the air storage tank is monitored in real time in the process, and if the pressure is too high, the valve SV2 is opened to slightly release air for decompression; when the control system receives an INFLATE command (inflation command), the valve SV3 is opened to store N in the air storage tank 2 O passes through a restrictor (restrictor valve) and then enters the balloon 3 through a return air passage of the balloon 3 to inflate the balloon 3The pressure inside the balloon 3 is monitored in real time in the process, and when the pressure inside the balloon 3 reaches the target pressure, the SV3 is closed, so that the inflation process is completed. The flow rate of the restrictor (restrictor valve) can be adjusted based on the inflation time during the host debugging process, so that the inflation time of the balloon 3 is in a proper range.
Referring to fig. 3 and 4 for schematic diagrams of balloon flow pressure control pipelines, the balloon 3 has a size adjusting function, after a user adjusts the size of the balloon 3 through a graphical interactive interface, the system calculates and determines the target pressure and the target flow of the balloon 3 according to the selected balloon size, seals pulmonary veins, and outputs ablation after confirming that the balloon 3 is well sealed through an imaging Device (DSA). The closed-loop control of the flow in fig. 3 corresponds to the "outer ring" adjusting part in fig. 4, and during the ablation process, the flow of the refrigerant flowing through the balloon 3 is monitored in real time through a mass flowmeter (the refrigerant is obtained by the normal temperature gas output by a gas source through a heat exchanger), the flow deviation is obtained by calculating with the target flow, and an intake pressure given value is given through PID control based on the flow deviation; the pressure closed-loop control in fig. 3 is realized by a front proportional valve and a first pressure sensor P1 (pressure detection) of a pipeline downstream of the front proportional valve, and corresponds to an 'inner ring' adjusting part in fig. 4, the pressure closed-loop control is a pressure closed-loop of the first pressure sensor P1, data of the first pressure sensor P1 are collected in real time, and compared with an intake pressure set value to obtain an intake pressure deviation, and the opening of the front proportional valve is adjusted by PID control based on the intake pressure deviation, so that the pressure closed-loop control is realized. In the ablation process, the pressure in the balloon 3 is monitored in real time (pressure detection) through a third pressure sensor P3, the pressure deviation is obtained after the pressure deviation is compared with the target pressure, and the closed-loop control of the balloon pressure is realized through the control of a proportional valve behind a PID (proportion integration differentiation). Therefore, in the flow closed loop process, the system realizes indirect control of the flow through the direct control of the front proportional valve on the inlet pressure. The whole system is monitored and adjusted in real time by setting sampling and flow rate periods, for example, 0.5s sampling and flow rate adjustment periods are set, and the flow rate of the refrigerant is adjusted by adjusting the inlet pressure given value every 0.5s, and the above adjustment periods are only taken as examples.
Therefore, in the cryoablation system, the closed-loop implementation mode of the flow of the control system of the main machine 1 of the cryoablation system is shown in fig. 4, and the delivery pressure of the refrigerant directly determines the flow of ablation because the structure of the working medium flow pipeline is fixed. The system realizes indirect PID closed-loop control on the melting flow through direct PID control on the air inlet pressure: the control system collects and circularly compares the target flow with the actual flow in real time through the mass flowmeter, and adjusts the air inlet pressure through control conversion; the downstream fluid pipeline of the front proportional valve is provided with a pressure sensor P1 so as to quickly feed back the air inlet conveying pressure, the front proportional valve is driven to quickly adjust the air inlet pressure to the designated pressure through PID closed-loop control, deviation is reduced, and finally the purpose of stabilizing flow is achieved.
In one embodiment, in order to achieve the size-adjustable function of the balloon 3, the cryoablation system achieves the size adjustment by controlling the inflation and ablation pressure of the balloon 3, and a compliant balloon is used as the balloon 3, and the diameter of the compliant balloon increases with the increase of the internal pressure according to a certain proportion within a certain pressure range. The balloon 3 used in the embodiment is Polyurethane (PU), and the PU balloon is soft, so that the damage to blood vessels, tissues and sheaths of the balloon 3 in the use process can be reduced, and the balloon can be tightly attached to the mouth of a pulmonary vein in filling; in addition, the large filling volume reduces the risk of rupture of the balloon 3.
In a second aspect, the present application further provides a cryoablation method with adjustable balloon size, using the cryoablation system with adjustable balloon size according to any one of the embodiments of the first aspect, referring to fig. 6, the method includes the following steps:
step 1, acquiring a set size of a balloon 3 (balloon size selection);
step 2, determining target pressure and target flow of the balloon 3 according to the set size;
step 3, inflating the balloon 3 to the target pressure by utilizing the inflation pipeline, enabling the balloon 3 to reach the set size, and performing pulmonary vein occlusion;
step 4, starting an ablation process, and monitoring and controlling the flow and the pressure of the balloon 3 in real time through the balloon flow pressure control pipeline to enable the pressure and the flow of the balloon 3 to respectively reach the target pressure and the target flow, wherein the method comprises flow closed-loop control, air inlet pressure control and balloon ablation pressure closed-loop control;
and 5, ending the ablation.
A detailed description will be given below of how the target pressure and the target flow rate of the balloon 3 are determined according to the set size with reference to fig. 7 and 8.
In one embodiment, the balloon pressure dimension characteristic is shown in fig. 7, where the balloon 3 has an outer diameter dimension of 23mm when the balloon pressure is 2PSI, corresponding to 28mm when the pressure is 3.7PSI, and 32mm when the pressure is 5PSI. Other balloon sizes for other pressures are shown in fig. 7, and can be calculated simply by d=3p+17, where D is the nominal outer diameter (in mm) of the balloon 3 being set and P is the inflation and ablation pressure (in PSI) required for its balloon 3. The outer diameter size characteristics of the balloon 3 corresponding to different pressures depend on the design and process treatment of the balloon 3, and can be adjusted based on the use requirements, and are not limited to the relationship between the nominal outer diameter of the balloon 3 and the pressure as exemplified in the present embodiment, and the above is only an example.
In one embodiment, the closed-loop targets of the corresponding flows are different when the balloons 3 are arranged in different sizes, and referring to fig. 8, in this embodiment, the corresponding flow is 6200sccm when the diameter of the balloon 3 is 23mm, 7200sccm when the diameter of the balloon 3 is 28mm, and 8000sccm when the diameter of the balloon 3 is 32mm. In order to ensure the effectiveness of ablation and continue the cognition and the use habit of doctors, the ablation flow of 23mm and 28mm is consistent with the flow design of the existing marketed products. The ablation flow corresponding to the other balloon sizes is shown in fig. 8, and can be calculated by a formula, q=200d+1600, where D is the nominal outer diameter (unit mm) of the balloon 3, Q is the ablation target flow (unit sccm) corresponding to the balloon 3, and the ablation flow corresponding to different sizes can be calculated in different manners, and is not limited to the relationship between the nominal outer diameter of the balloon 3 and the ablation target flow, which is listed in the embodiment, and the above is only taken as an example.
As shown in fig. 9, in this embodiment, the pressure curve of the balloon 3 is obtained by using the same balloon catheter for three continuous ablations (the ablation time is 180 s) under the condition of different outer diameter setting, the time is on the abscissa, the pressure of the balloon 3 is on the ordinate, (1) when the diameter of the balloon 3 is set to 23mm, the pressure of the balloon 3 is controlled to be 2PSI; (2) when the diameter of the balloon 3 is set to be 28mm, the pressure in the balloon 3 is controlled to be 3.7PSI; (3) when the diameter of the balloon 3 was set to 32mm, the pressure in the balloon 3 was controlled to 5PSI. The graph illustrates the achievement of the target pressure, and the pressure control in the balloon 3 stabilizes.
As shown in fig. 10, in this embodiment, the flow rate curve of the balloon 3, which is obtained by continuously ablating three times (the same ablation as in fig. 9) using the same balloon catheter under different outer diameter setting conditions, is time on the abscissa, and ablation flow rate on the ordinate, (1) when the diameter of the balloon 3 is set to 23mm, the flow rate of the refrigerant passing through the balloon 3 is 6200sccm; (2) when the diameter of the balloon 3 is set to 28mm, the flow rate of the refrigerant passing through the balloon 3 is 7200sccm; (3) when the diameter of the balloon 3 was set to 32mm, the flow rate of the refrigerant passing through the balloon 3 was 8000sccm. The graph illustrates the realization of the target flow rate and the control is stable.
In one embodiment, the balloon 3 is inflated at the same balloon pressure as the balloon 3 is ablated, and/or,
the pressure in the rewarming stage after the ablation of the balloon 3 is the same as the pressure during the ablation of the balloon 3.
In this embodiment, the balloon 3 of the cryoablation system has the same balloon pressure and ablation pressure when inflated under the same size setting condition, so that the balloon 3 can be ensured to be inflated and stably transited to the ablation stage until the end under the condition of good sealing of the pulmonary veins. The design can reduce the occurrence of poor abutment caused by inconsistent ablation pressure and inflation pressure (the ablation pressure in the prior art is far greater than the inflation pressure).
In addition, the balloon 3 of the cryoablation system is also the same as the ablation pressure at the same sizing conditions, and the pressure of the re-Wen Shiqiu balloon: after the ablation time is over, the system stops the input of the refrigerant, and simultaneously controls the rear proportional valve to keep the balloon 3 at a certain pressure, and when the temperature of the balloon 3 is restored to a proper temperature (more than or equal to 20 ℃), the balloon 3 is contracted. The design can reduce mechanical damage to myocardial tissue in a low-temperature frozen state caused by morphological change due to pressure change in the balloon 3, and improve the safety of the system.
The relationship between balloon-myocardial adhesion and temperature is mentioned in "Chinese expert's consensus 2020 for atrial fibrillation ablation via cryoballoon catheters: effective abutment produces effective damage'. The temperature during the freezing process has a certain correlation with the balloon-myocardium abutment. The freezing model experiment proves that the cryoablation can generate tissue injury on the abutting surface of the saccule; the poor adhesion part is difficult to generate effective tissue damage even if the freezing time is prolonged; the study under the MRI guidance also proves that the tissue damage can be generated only by effectively attaching the cryoballoon to myocardial tissue, and the cryoablation system with the adjustable balloon size in the embodiment of the application can select proper size for pulmonary veins with different structures by arranging the size of the balloon, so that better attachment is achieved, more effective damage is formed, and the safety and effectiveness of the cryoballoon ablation system for treating atrial fibrillation are improved.
The foregoing is merely illustrative of the present application, and the present application is not limited thereto, and any changes or substitutions easily contemplated by those skilled in the art within the scope of the present application should be included in the present application. Therefore, the protection scope of the application is subject to the protection scope of the claims.
Claims (10)
1. The cryoablation system with the adjustable balloon size is characterized by comprising a balloon (3), a tube body part (4) and a control part, wherein the balloon (3), the tube body part (4) and the control part are sequentially connected, the control part comprises an inflation pipeline and a balloon flow pressure control pipeline, the inflation pipeline is connected with the balloon (3) through the tube body part (4), the inflation pipeline is used for controlling the size of the balloon (3) by inflating the balloon (3) to a target pressure corresponding to the size of the balloon (3), the balloon flow pressure control pipeline is connected with the balloon (3) through the tube body part (4), and the balloon flow pressure control pipeline is used for controlling the gas flow and the pressure in the balloon (3) in an ablation process.
2. The cryoablation system of claim 1 wherein the inflation line comprises a gas source, a first valve, a gas reservoir, a third valve, and a restrictor connected in sequence, the restrictor being connected to the tube portion (4); the balloon flow pressure control pipeline comprises a front proportional valve, a first pressure sensor, a heat exchanger, an air inlet of the pipe body part, an air outlet of the pipe body part, a rear proportional valve, a vacuum pump and a mass flowmeter which are connected in sequence, wherein the front proportional valve is connected with the air source; in the ablation process, the control of the air inlet pressure by the front proportional valve realizes the flow closed-loop control of the balloon (3), and the pressure closed-loop control of the balloon (3) is realized by the rear proportional valve.
3. The cryoablation system of claim 2 wherein a second pressure sensor is provided on the air reservoir, a second valve is provided between the first valve and the air reservoir, and the second valve is connected to an exhaust recovery assembly.
4. The cryoablation system of claim 2 wherein a filter for filtering impurities is provided at the air outlet of the air source.
5. The balloon-size-adjustable cryoablation system of claim 2 wherein a pressure relief valve is provided between the air source and the air reservoir.
6. The cryoablation system of claim 1 wherein the system further comprises a graphical interactive platform communicatively coupled to the control component through which the control component and balloon (3) are visually displayed.
7. The cryoablation system of any of claims 1-7 wherein the tube portion (4) is connected to the control member by coaxial fluid connection tubing and connection cable.
8. The cryoablation system of any of claims 1-7 wherein a temperature sensor and a third pressure sensor are provided within the balloon (3).
9. A method of cryoablation with adjustable balloon size using the cryoablation system of any of claims 1-8, the method comprising:
acquiring a set size of the balloon (3);
determining a target pressure and a target flow of the balloon (3) according to the set size;
inflating the balloon (3) to the target pressure by utilizing the inflation pipeline, so that the balloon (3) reaches the set size and is blocked;
and starting an ablation process, and monitoring and controlling the flow and the pressure of the balloon (3) in real time through the balloon flow pressure control pipeline so that the pressure and the flow of the balloon (3) respectively reach the target pressure and the target flow.
10. The cryoablation method with adjustable balloon size according to claim 9, characterized in that the balloon (3) is inflated at the same balloon pressure as the balloon (3) is ablated and/or,
the pressure of the re-warming stage after the balloon (3) is the same as the pressure of the balloon (3) during the ablation.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311130334.6A CN117159121A (en) | 2023-09-04 | 2023-09-04 | Cryoablation system and method with adjustable balloon size |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311130334.6A CN117159121A (en) | 2023-09-04 | 2023-09-04 | Cryoablation system and method with adjustable balloon size |
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| Publication Number | Publication Date |
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| CN117159121A true CN117159121A (en) | 2023-12-05 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202311130334.6A Pending CN117159121A (en) | 2023-09-04 | 2023-09-04 | Cryoablation system and method with adjustable balloon size |
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| Country | Link |
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| CN (1) | CN117159121A (en) |
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2023
- 2023-09-04 CN CN202311130334.6A patent/CN117159121A/en active Pending
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