CN110897710A

CN110897710A - Control method and system of pulmonary nerve ablation system and computer medium

Info

Publication number: CN110897710A
Application number: CN201911209167.8A
Authority: CN
Inventors: 徐宏; 秦翔翔; 冯晓杰
Original assignee: Hangzhou Kunbo Biotechnology Co Ltd
Current assignee: Hangzhou Kunbo Biotechnology Co Ltd
Priority date: 2019-11-30
Filing date: 2019-11-30
Publication date: 2020-03-24
Anticipated expiration: 2039-11-30
Also published as: CN110897710B

Abstract

The application discloses a control method, a system and a computer medium of a pulmonary nerve ablation system, wherein the control method of a radio frequency ablation system for implementing pulmonary nerve ablation is included, the pulmonary nerve ablation system comprises at least one electrode for releasing energy, a temperature sensor for collecting temperature information of each electrode part, and a cooling medium delivery device for providing cooling medium for each electrode, and the control method is characterized by comprising the following steps of: s100, acquiring temperature information of an electrode part in an ablation process; step S110, comparing the temperature information with a temperature threshold value; and step S120, correspondingly delivering a cooling medium to the electrode part according to the relation between the temperature information and the temperature threshold value until the ablation is finished. According to the technical scheme, stable, convenient and accurate ablation operation is realized by monitoring various parameters in the ablation process, and the efficiency of the operation and the treatment effect are improved.

Description

Control method and system of pulmonary nerve ablation system and computer medium

Technical Field

The present application relates to the field of interventional therapy, and in particular to a method, system and computer medium for controlling a pulmonary nerve ablation system.

Background

Chronic Obstructive Pulmonary Disease (COPD) is the most common Disease of the respiratory system, and has been shown in our country to be around 10% in adults over 40 years of age, based on current epidemiological survey evidence.

Currently, COPD mainly depends on drug therapy, and most of the drugs are anticholinergic drugs for specific blocking of M receptors, which causes relaxation of airway smooth muscle, airway relaxation and reduction of mucus secretion, thereby alleviating airway obstruction and relieving symptoms of COPD patients, while ablation of pulmonary denervation Therapy (TLD) pulmonary denervation therapy aims at parasympathetic nerves, blocks the dominant action thereof, and achieves permanent anticholinergic action. This approach has completed a feasible clinical study in 2015, and further clinical trials are currently underway.

With the continuous improvement of society on COPD and the continuous development of interventional technology, the treatment of chronic obstructive pulmonary disease through airway interventional technology has gained various recognition, and TLD as one of the treatment methods has the advantages of more thorough and more efficient treatment compared with the drug treatment. Therefore, the development of the TLD ablation catheter and the matched equipment thereof is planned to provide technical support for a new method for treating the chronic obstructive pulmonary disease.

As a new trend in recent years to treat COPD, TLD ablation is required to ablate the parasympathetic nerves around the main bronchi, block their innervation, achieve permanent anticholinergic effects, reduce airway smooth muscle tone, reduce mucus secretion, and improve clinical symptoms of chronic obstructive pulmonary disease.

In the ablation process, the inner wall of the main bronchus needs to be ablated in a ring shape, and an ablation point forms a closed ring on the inner wall of the main bronchus, so that effective blocking can be performed.

The inventor finds that most of the ring-shaped catheters in the related technology are electrophysiology mapping catheters, and most of the ablation catheters are single-pole ablation catheters, so that multiple ablations are needed in the treatment process, and the ablations form a closed ring, so that the operation process is complicated, and the treatment effect is not easy to control. The ablation degree is insufficient, and the ablation points are not easy to form a closed ring and are difficult to effectively block; the degree of ablation is excessive, the injury is too large, and the recovery process of the patient is not favorable.

Meanwhile, the internal cavity diameter of the breathing pipeline is gradually reduced along with the deep intervention, the form of the ablation electrode in the related technology is relatively determined, the adaptability to different arranged target tissues is poor, the ablation position is too high easily, excessive nerve inactivation is caused, and the influence on a patient is large.

Disclosure of Invention

In order to solve the above problems, the present application discloses a control method of a radio frequency ablation system for performing pulmonary nerve ablation, the radio frequency ablation system including at least one electrode for releasing energy, a temperature sensor for collecting temperature information of each electrode site, and a cooling medium delivery device for providing a cooling medium to each electrode, the control method including, for each electrode:

s100, acquiring temperature information of an electrode part in an ablation process;

step S110, comparing the temperature information with a temperature threshold value;

and step S120, correspondingly delivering a cooling medium to the electrode part according to the relation between the temperature information and the temperature threshold value until the ablation is finished.

Several alternatives are provided below, but not as an additional limitation to the above general solution, but merely as a further addition or preference, each alternative being combinable individually for the above general solution or among several alternatives without technical or logical contradictions.

Optionally, the temperature threshold is 55 ℃ to 65 ℃, when the temperature information is higher than the temperature threshold, the flow rate of the cooling medium is increased, otherwise, the current flow rate is maintained.

Optionally, the flow rate of the cooling medium is adjusted within a range of 3-15 ml/min.

Optionally, the control method further includes:

and when the temperature information is higher than the temperature threshold value, reducing the power of the electrode, otherwise, keeping the current power.

Optionally, the power of the electrode is adjusted in a range of 3-10W.

Optionally, the control method further comprises monitoring the ablation time, and when the ablation time reaches 60s-120s, the ablation is finished.

The application also discloses a radiofrequency ablation system for performing pulmonary nerve ablation, the radiofrequency ablation system comprising at least one electrode for delivering energy, the radiofrequency ablation system further comprising:

the detection module is used for acquiring temperature information of the electrode part in the ablation process;

the judging module is used for comparing the temperature information with a temperature threshold value;

and the driving module is controlled by the judging module and correspondingly conveys a cooling medium to the electrode part according to the relation between the temperature information and the temperature threshold until the ablation is finished.

The application also discloses a radio frequency ablation system for implementing pulmonary nerve ablation, which comprises a processor and a memory, wherein the memory stores a computer program, and the processor executes the computer program to realize the following steps:

and acquiring temperature information of an electrode working circuit, and sending a corresponding energy release driving signal to the electrode according to the temperature information.

The application also discloses a control method of the pulmonary nerve ablation system, the pulmonary nerve ablation system comprises at least one electrode for releasing energy and a cooling medium delivery device for providing a cooling medium for each electrode, and the control method comprises the following steps:

s200, acquiring impedance information of an electrode working circuit in an ablation process;

and step S210, generating a corresponding control instruction according to the impedance information so as to adjust the flow of the cooling medium.

Optionally, the method further comprises calibrating the steady-state impedance in advance, and calculating a threshold value according to the steady-state impedance, wherein the threshold value is used for being compared with the impedance information to generate a corresponding regulating cooling medium flow.

Optionally, the steady-state impedance is calibrated in such a way that after the radiofrequency ablation catheter is in place in the body, the heat exchange medium is output at an initial flow rate before the electrodes are powered on, impedance information is collected in real time, and when the impedance information is stable, the corresponding value is recorded as the steady-state impedance.

Optionally, in step S210, generating a corresponding control instruction according to the impedance information specifically includes:

step S211, comparing the impedance information with a threshold value, and judging the increase and decrease of the flow rate according to the relation between the impedance information and the threshold value;

step S212, according to the increase and decrease of the flow, corresponding control commands are generated according to the preset increase and decrease degrees.

Optionally, the threshold is a numerical range, and in step S211, the determining, according to the relationship between the impedance information and the threshold, an increase or decrease of the flow rate specifically includes:

when the impedance information is larger than the upper threshold, determining to increase the flow;

when the impedance information is smaller than the lower threshold, determining to reduce the flow;

when the impedance information is within the threshold range, maintaining the current flow;

in step S211, when it is determined that the flow rate is increased, a first control instruction is generated in step S212, where the flow rate of the heat exchange medium corresponding to the first control instruction is greater than the current flow rate;

if it is determined in step S211 that the flow rate is decreased, a second control command is generated in step S212, and the flow rate of the heat exchange medium corresponding to the second control command is smaller than the current flow rate.

Optionally, step S200 and step S210 are executed in a loop according to the sampling period of the impedance information;

after a control instruction is generated and output in the last sampling period, in the next period, after impedance information is collected, before the impedance information is compared with a threshold value, the impedance information is compared with the impedance information in the last sampling period, and the change trend of the impedance information is judged;

and correspondingly changing the adjusting amplitude of the flow of the heat exchange medium or selecting one of the upper threshold and the lower threshold according to the change trend of the impedance information.

Optionally, after the first control instruction is generated and output in the previous sampling period, in the next period, comparing the impedance information with the impedance information in the previous sampling period before comparing the impedance information with the threshold value, and determining a variation trend of the impedance information;

when the change trend of the impedance information is rising, the adjusting range of the flow of the heat exchange medium is increased;

when the change trend of the impedance information is descending, the impedance information of the current sampling period is compared with the lower threshold limit.

Optionally, after the second control instruction is generated and output in the previous sampling period, in the next period, comparing the impedance information with the impedance information in the previous sampling period before comparing the impedance information with the threshold value, and determining a variation trend of the impedance information;

when the change trend of the impedance information is descending, the adjusting range of the flow of the heat exchange medium is increased;

when the change trend of the impedance information is rising, the impedance information of the current sampling period is compared with the upper threshold limit.

The present application also discloses a pulmonary nerve ablation system comprising at least one electrode for delivering energy, the radiofrequency ablation system further comprising:

the detection module is used for acquiring impedance information of an electrode part in an ablation process;

the judging module is used for comparing the impedance information with an impedance threshold value;

and the driving module is controlled by the judging module and correspondingly conveys a cooling medium to the electrode part according to the relation between the impedance information and the impedance threshold value until the ablation is finished.

The application also discloses a pulmonary nerve ablation system, comprising a processor and a memory, wherein the memory stores a computer program, and the processor executes the computer program to realize the following steps:

and acquiring impedance information of an electrode working circuit, and sending a corresponding energy release driving signal to the electrode according to the impedance information. This application has realized through the setting of inflation portion that core pipe subassembly can both realize stable, convenient, accurate the operation of melting to different positions, the breathing pipe of form, has improved the efficiency of operation and the effect of treatment.

Specific advantageous effects will be explained in the detailed description in conjunction with specific examples.

Drawings

FIGS. 1 a-1 c are schematic views of an exemplary RF ablation catheter;

fig. 2a to 2b are schematic views of an expansion part in a second embodiment;

FIGS. 3a to 3e are schematic views of an expansion part in a third embodiment;

fig. 4a and 4b are schematic views illustrating the installation of the connector;

FIG. 5 is an enlarged partial schematic view of FIG. 3 d;

FIGS. 6a to 6f are schematic views of cooling medium passages in the second embodiment;

FIGS. 7a to 7c are schematic views of a cooling medium passage in the third embodiment;

FIG. 8 is a schematic view of a wetting hole on an electrode;

FIGS. 9a to 9b are schematic views showing changes of the annular expansion part;

FIGS. 10a to 10b are schematic views showing the detailed arrangement of the annular expansion part;

FIGS. 11 a-11 c are schematic views of a sheath of an RF ablation system in accordance with an embodiment;

fig. 12a to 12c are schematic diagrams of a control method;

fig. 13 is a schematic diagram of a computer device of the rf ablation system;

fig. 14 is a schematic view of the use state of the radio frequency ablation catheter.

The reference numerals in the figures are illustrated as follows:

1. a core tube assembly; 11. an expansion part; 111. an elastic rod; 1111. a cavity; 1112. a sleeve; 112. a connector; 1121. a center block; 1122. a fastening cap; 1123. an adaptation structure; 113. a first channel; 114. a second channel; 115. an end cap; 12. a core tube; 13. a delivery channel; 131. an output port; 132. a sleeve; 14. a control segment; 15. protecting the tube;

2. an electrode; 21. a socket is butted; 211. an annular projection; 22. an electrode card slot;

3. a sheath tube;

4. core pulling;

51. infiltrating the pores;

6. a stress relief tube; 61. a handle; 611. a pipe joint; 612. a circuit connector; 613. a threading channel; 614. an elastic clamping jaw; 615. tightening the nut; 62. a guide member; 621. a guide port; 63. a traction member; 631. a traction body; 632. a radial rod; 633. an anchor head; 634. avoiding the through hole; 64. a force application member; 641. a thread groove; 7. a bronchoscope.

Detailed Description

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. When a component is referred to as being "disposed on" another component, it can be directly on the other component or intervening components may also be present.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the present application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

With reference to fig. 12a to 12c, the present application further discloses a control method of a radiofrequency ablation system for performing pulmonary nerve ablation, the radiofrequency ablation system comprising at least one electrode for releasing energy, a temperature sensor for collecting temperature information of each electrode site, and a cooling medium delivery device for providing a cooling medium to each electrode, the control method comprising, for each electrode:

Before step S100, the tip of the rf ablation catheter is first positioned near the target point, the distal tip of the electrode is generally made to correspond to the center of the lesion site, and then the electrode is powered on to begin ablation, and the temperature parameters obtained in real time can be collected in real time by using the thermistor or the temperature detection device (hereinafter also referred to as a temperature detection device), and the specific collection method can also be implemented by combining with other prior art.

The temperature parameter has a corresponding detection position in space, namely, the position of the temperature detection device, and although means or methods for acquiring the temperature parameter are adopted in the prior art, the temperature parameter is mostly limited to the position of the electrode.

In one embodiment, the temperature threshold is 55 ℃ to 65 ℃, and when the temperature information is higher than the temperature threshold, the flow rate of the cooling medium is increased, otherwise, the current flow rate is maintained.

The setting relationship comprises that the edge temperature parameter reaches the temperature threshold value and keeps a preset time interval.

The conventional ablation operation generally presets ablation time, and ablation is stopped after the preset ablation time is reached, but the ablation effect cannot be guaranteed, and in the embodiment, the ablation end point is determined by the temperature change at a specified position in the temperature field, so that the ablation effect can be further guaranteed.

In one embodiment, the flow rate of the cooling medium is adjusted in the range of 3-15 ml/min.

In the actual ablation process, the flow can be manually controlled or regulated and controlled by the system according to preset parameters. The system can also be adjusted manually to be a main system for adjustment as an auxiliary system, for example, when the system is manually set to be automatically adjusted, the system is adjusted and controlled according to temperature parameters, when the temperature is higher than a certain preset value, the flow of the cooling medium is increased, and when the temperature is lower than the certain preset value, the flow of the cooling medium is reduced; when the system is manually set to suspend regulation, the system regulates and controls according to the temperature parameters, when the temperature is higher than a certain preset value, the system prompts that the flow of the cooling medium needs to be increased, and when the temperature is lower than the certain preset value, the system prompts that the flow of the cooling medium needs to be reduced;

in one embodiment, the control method further comprises:

Correspondingly, the method for controlling the temperature rise can be adjusted by the current power of the electrode besides the cooling medium,

in one embodiment, the power of the electrode is adjusted in the range of 3-10W.

In one embodiment, the control method further comprises monitoring the ablation time, and when the ablation time reaches 60s-120s, the ablation is ended.

The range is obtained by combining a use scene and design requirements through multiple tests, and the inventor finds that when the parameters are not reasonably set, severe bursting of an ablation point can occur in the effect process, the power is too high, skin tissues are seriously damaged, and the like, so that the range is reasonable and preferable for controlling the ablation effect.

It should be understood that although the various steps in the flowchart of fig. 12a are shown in order as indicated by the arrows, the steps are not necessarily performed in order as indicated by the arrows. The steps are not performed in the exact order shown and described, and may be performed in other orders, unless explicitly stated otherwise. Moreover, at least a portion of the steps in fig. 12a may include multiple sub-steps or multiple stages that are not necessarily performed at the same time, but may be performed at different times, and the order of performing the sub-steps or stages is not necessarily sequential, but may be performed in turn or alternately with other steps or at least a portion of the sub-steps or stages of other steps.

In one embodiment, there is provided a radio frequency ablation system for performing pulmonary nerve ablation, the radio frequency ablation system including at least one electrode for delivering energy, the radio frequency ablation system further including:

and the driving module is controlled by the judging module and correspondingly conveys the cooling medium to the electrode part according to the relation between the temperature information and the temperature threshold value until the ablation is finished.

For specific definition and other details of the rf ablation system, reference may be made to the above definition of the control method of the rf ablation system for performing pulmonary nerve ablation, which is not described herein again. The various modules in the rf ablation system described above may be implemented in whole or in part by software, hardware, and combinations thereof. The modules can be embedded in a hardware form or independent from a processor in the computer device, and can also be stored in a memory in the computer device in a software form, so that the processor can call and execute operations corresponding to the modules.

In one embodiment, another rf ablation system for pulmonary nerve ablation is provided, which includes a processor and a memory, wherein the memory stores a computer program, and the processor executes the computer program to implement the following steps:

The rf ablation system in this embodiment is a computer device, which may be a terminal, and its internal structure diagram may be as shown in fig. 13. The computer device includes a processor, a memory, a network interface, a display screen, and an input device connected by a system bus. Wherein the processor of the computer device is configured to provide computing and control capabilities. The memory of the computer device comprises a nonvolatile storage medium and an internal memory. The non-volatile storage medium stores an operating system and a computer program. The internal memory provides an environment for the operation of an operating system and computer programs in the non-volatile storage medium. The network interface of the computer device is used for communicating with an external terminal through a network connection. The computer program is executed by a processor to implement the above control method of a radio frequency ablation system for performing pulmonary nerve ablation. The display screen of the computer equipment can be a liquid crystal display screen or an electronic ink display screen, and the input device of the computer equipment can be a touch layer covered on the display screen, a key, a track ball or a touch pad arranged on the shell of the computer equipment, an external keyboard, a touch pad or a mouse and the like.

Those skilled in the art will appreciate that the architecture shown in fig. 13 is merely a block diagram of some of the structures associated with the disclosed aspects and is not intended to limit the computing devices to which the disclosed aspects apply, as particular computing devices may include more or less components than those shown, or may combine certain components, or have a different arrangement of components.

With reference to fig. 12b, the present application further discloses a control method of a pulmonary nerve ablation system, the radiofrequency ablation system comprising at least one electrode for releasing energy, and a cooling medium delivery device for providing a cooling medium to the electrodes, the control method comprising, for each electrode:

The control instruction has various forms in actual operation, not only can directly disconnect the power supply of the electrode, but also can give prompt information, and utilizes the temperature information to prompt or control the ablation process, and logically can utilize the impedance information to control the flow of the cooling medium without correlation, and utilizes the impedance information to control the flow of the cooling medium to emphasize the regulation and control of the ablation process, and utilizes the temperature information to prompt or control the ablation process to only intervene on important process nodes.

In one embodiment, the method further comprises pre-calibrating the steady-state impedance, and calculating a threshold value based on the steady-state impedance, the threshold value being used to compare with the impedance information to generate a corresponding adjusted cooling medium flow.

In one embodiment, the steady-state impedance is calibrated in such a way that after the radiofrequency ablation catheter is in place in a body, the cooling medium is output at an initial flow rate before the electrodes are electrified, impedance information is collected in real time, and when the impedance information is stable, the corresponding value is recorded as the steady-state impedance.

The electrodes are electrified to start ablation, impedance information is collected in real time, the obtained impedance information is continuously compared with a threshold value, a corresponding control instruction is generated to adjust the flow of the cooling medium, the threshold value is a range, and the lower-limit impedance can adopt steady-state impedance.

As the ablation is carried out, the impedance rises, and when the impedance information is greater than the set upper limit impedance, a first control instruction is generated and sent, namely the flow of the cooling medium is increased;

then comparing the impedance information of the next sampling period with the impedance information of the previous sampling period, judging whether the impedance rises, if so, generating and sending a first control instruction again, namely further increasing the flow of the cooling medium;

if the impedance starts to decrease without increasing, generating and transmitting a second control command, that is, reducing the flow rate of the cooling medium, when the impedance information is smaller than the set lower limit impedance, as compared with the lower limit impedance;

and then comparing the impedance information of the next sampling period with the impedance information of the previous sampling period, judging whether the impedance is reduced, if so, generating and sending a second control instruction again, namely, further reducing the flow of the cooling medium until the impedance starts to rise.

Based on the above circulation, the impedance information is continuously monitored in the ablation process, and the flow of the cooling medium is adjusted, so that the ablation is prompted or stopped when preset conditions are met, such as time calculation or temperature monitoring.

Referring to fig. 12c, in an embodiment, in step S210, generating a corresponding control command according to the impedance information specifically includes:

In an embodiment, the threshold is a numerical range, and the determining the increase or decrease of the flow rate according to the relationship between the impedance information and the threshold in step S211 specifically includes:

when it is determined in step S211 that the flow rate is increased, a first control command is generated in step S212, and the flow rate of the cooling medium corresponding to the first control command is larger than the current flow rate;

if it is determined in step S211 that the flow rate is decreased, a second control command is generated in step S212, and the flow rate of the cooling medium corresponding to the second control command is smaller than the current flow rate.

In one embodiment, step S200 and step S210 are executed in a loop according to the sampling period of the impedance information;

according to the change trend of the impedance information, the adjustment amplitude of the flow of the cooling medium is correspondingly changed or one of the upper threshold and the lower threshold is selected for comparison.

In one embodiment, after the first control instruction is generated and output in the last sampling period, in the next period, comparing the impedance information with the impedance information in the last sampling period before comparing the impedance information with the threshold value, and judging the variation trend of the impedance information;

when the change trend of the impedance information is rising, the adjusting amplitude of the flow of the cooling medium is increased;

In one embodiment, after the second control instruction is generated and output in the previous sampling period, in the next period, comparing the impedance information with the impedance information in the previous sampling period before comparing the impedance information with the threshold value, and judging the variation trend of the impedance information;

when the change trend of the impedance information is descending, the adjusting amplitude of the flow of the cooling medium is increased;

It should be understood that although the steps in the flowcharts of fig. 12b and 12c are shown in order as indicated by the arrows, the steps are not necessarily performed in order as indicated by the arrows. The steps are not performed in the exact order shown and described, and may be performed in other orders, unless explicitly stated otherwise. Also, at least some of the steps in fig. 12b and 12c may include multiple sub-steps or multiple stages, which are not necessarily performed at the same time, but may be performed at different times, which are not necessarily performed in sequence, but may be performed alternately or alternatingly with other steps or at least some of the sub-steps or stages of other steps. In one embodiment, there is provided a pulmonary nerve ablation system, the rf ablation system including at least one electrode for delivering energy, the rf ablation system further including:

the detection module is used for acquiring impedance information of an electrode working circuit in the ablation process;

and the driving module is used for generating a corresponding control instruction according to the impedance information so as to adjust the flow of the cooling medium.

For specific definition of the rf ablation system and other details, reference may be made to the above definition of the control method for the pulmonary nerve ablation system, which is not described in detail here. The various modules in the rf ablation system described above may be implemented in whole or in part by software, hardware, and combinations thereof. The modules can be embedded in a hardware form or independent from a processor in the computer device, and can also be stored in a memory in the computer device in a software form, so that the processor can call and execute operations corresponding to the modules.

In one embodiment, a pulmonary nerve ablation system is provided, comprising a processor and a memory, the memory having a computer program stored therein, the processor implementing the following steps when executing the computer program:

The rf ablation system in this embodiment is a computer device, which may be a terminal, and its internal structure diagram may be as shown in fig. 13. The computer device includes a processor, a memory, a network interface, a display screen, and an input device connected by a system bus. Wherein the processor of the computer device is configured to provide computing and control capabilities. The memory of the computer device comprises a nonvolatile storage medium and an internal memory. The non-volatile storage medium stores an operating system and a computer program. The internal memory provides an environment for the operation of an operating system and computer programs in the non-volatile storage medium. The network interface of the computer device is used for communicating with an external terminal through a network connection. The computer program is executed by a processor to implement the above control method of the pulmonary nerve ablation system. The display screen of the computer equipment can be a liquid crystal display screen or an electronic ink display screen, and the input device of the computer equipment can be a touch layer covered on the display screen, a key, a track ball or a touch pad arranged on the shell of the computer equipment, an external keyboard, a touch pad or a mouse and the like.

The application also discloses a computer readable storage medium having stored thereon a computer program which, when executed by a processor, implements the steps of the above-described radio frequency ablation method.

In one embodiment, a method of frequency ablation comprises:

In addition, the details of each step can be referred to the above definition of the relevant part of the control method of the radiofrequency ablation system for implementing the pulmonary nerve ablation, and are not described herein again.

In another embodiment, a method of frequency ablation comprises:

See the above definitions of relevant parts of the control method of the rf ablation system for performing the pulmonary nerve ablation, and are not described in detail here.

It will be understood by those skilled in the art that all or part of the processes of the methods of the embodiments described above can be implemented by hardware instructions of a computer program, which can be stored in a non-volatile computer-readable storage medium, and when executed, can include the processes of the embodiments of the methods described above. Any reference to memory, storage, database, or other medium used in the embodiments provided herein may include non-volatile and/or volatile memory, among others. Non-volatile memory can include read-only memory (ROM), Programmable ROM (PROM), Electrically Programmable ROM (EPROM), Electrically Erasable Programmable ROM (EEPROM), or flash memory. Volatile memory can include Random Access Memory (RAM) or external cache memory. By way of illustration and not limitation, RAM is available in a variety of forms such as Static RAM (SRAM), Dynamic RAM (DRAM), Synchronous DRAM (SDRAM), Double Data Rate SDRAM (DDRSDRAM), Enhanced SDRAM (ESDRAM), Synchronous Link DRAM (SLDRAM), Rambus Direct RAM (RDRAM), direct bus dynamic RAM (DRDRAM), and memory bus dynamic RAM (RDRAM).

The above-described solution can be achieved by applying any of the radiofrequency ablation devices disclosed hereinafter.

In the embodiment disclosed with reference to fig. 1a to 1c, the present embodiment discloses a radiofrequency ablation catheter for performing pulmonary nerve ablation, comprising a core tube assembly 1 and a plurality of electrodes 2 mounted on the core tube assembly 1; the distal end of the core tube assembly 1 is provided with an expansion part 11, and a plurality of electrodes 2 are arranged on the expansion part 11 at intervals; a delivery channel 13 is further provided in the interior of the core tube assembly 1, one end of the delivery channel 13 is used for connecting a cooling medium delivery device, and the other end extends to the expansion part 11 and is provided with an output port 131 for each electrode 2.

The rf ablation catheter in this embodiment is entered through the bronchoscope through the airway to the target site. The respiratory tract has larger difference compared with other interventional paths, and the cavity diameter of other interventional paths has less change degree; while the airway lumen diameter varies to a greater extent. Therefore, the radiofrequency ablation catheter realizes treatment of different target positions through the core tube assembly 1 provided with the expansion part 11. The expansion part 11 can change the volume of the expansion part, so that the electrode 2 arranged on the expansion part 11 is stopped close to the target position to match with the respiratory tracts with different cavity diameters.

During ablation, a cooling medium needs to be delivered. The cooling medium can prevent the target tissue from being over-heated in the ablation process to influence the treatment effect. In the embodiment, the output ports 131 are designed independently for the plurality of electrodes 2, so that the ablation parameters of the plurality of electrodes 2 can be controlled independently. The electrodes 2 are provided with independent output ports 131, so that a structural basis can be provided for independently controlling ablation parameters by the single electrode 2, and better ablation effect can be achieved.

Whether the electrode 2 can approach the target point in an appropriate posture depends on the deformed posture of the expansion portion 11. In the embodiment shown with reference to fig. 2a, the core tube assembly 1 comprises a core tube 12 and an expansion 11; the core tube 12 has opposite distal and proximal ends, the expansion portion 11 is connected to the distal end of the core tube 12, and the expansion portion 11 in an expanded state is a three-dimensional netpen shape.

The expansion part 11 has different specifications in the expanded state and the loaded state. When the expansion part 11 is in the loading state, a smaller volume and higher flexibility are required to facilitate intervention operation of medical staff and other operators; when the expansion part 11 is in an expansion state, a larger deformation amount is needed to ensure that the expansion part can be attached to target positions with different inner diameter sizes; when the expansion part 11 enters the expansion state from the installation state, the deformation of the expansion part 11 needs to be controlled linearly, so that the operation of operators such as medical staff is facilitated. In view of the above requirements, the expansion part 11 in this embodiment is preferably in a three-dimensional netpen shape, and the netpen-shaped expansion part 11 can ensure a smaller volume and higher flexibility in a loading state, a larger volume in an expansion state and controllability of a deformation process. The solid mesh cage may be, for example, a sphere, an ellipsoid, a cylinder, etc., but it is required that the geometric shape thereof is very regular and is only a rough shape characteristic, and the density of the mesh cage is not strictly limited.

In one embodiment, the expansion part 11 includes a plurality of solid elastic rods 111, one end of each of the plurality of elastic rods 111 is connected in a converging manner, and the other end is fixedly inserted into a distal portion of the core tube.

The expansion part 11 has elasticity by the elastic rod 111 itself, but the direction of the elasticity can be optimally selected.

For example, in one embodiment, each of the flexible rods 111 is pre-configured to a radially expanded state, and each of the flexible rods 111 is brought into an expanded state by:

the expansion state is entered by the elasticity of the self body; or

The distal end of each elastic rod 111 is directly or indirectly connected with a pull core 4, and the pull core 4 extends towards the proximal end for drawing the elastic rod 111 to deform to enter the expansion state.

The elastic force of the elastic rod 111 can drive the expansion part 11 to enter an expansion state, that is, the expansion part 11 is in a radial expansion state when no external force is applied, and the expansion part can be generally wrapped and furled by matching with a sheath tube which slides relative to a core tube during loading, so that the expansion part 11 is limited in the loading state. At this time, the pull core 4 can be omitted, and the pull core 4 can be matched, so that the posture of the expansion part can be accurately regulated and controlled.

In another embodiment, for example, each of the elastic rods 111 is pre-configured in a radially collapsed state, and a pull core 4 is directly or indirectly attached to a distal end of each of the elastic rods 111, the pull core 4 extending proximally for pulling the elastic rods to deform to enter an expanded state.

The expansion part 11 is in a loading state of being radially folded when no external force is applied, and at this time, the pull core 4 is used in cooperation, and the expansion part is driven to enter an expansion state by the pull core 4.

The elastic bars 111 do not affect the arrangement of the electrodes in the different states of the pre-shaping and are therefore not separately distinguishable below.

In the specific arrangement of the electrode 2, with reference to the embodiment shown in fig. 2b, the electrode 2 is arranged on the outer circumferential surface of the expansion part 11.

The outer peripheral surface of the expansion part 11 is the most easily contacted part with the inner wall of the respiratory tract, and the electrode 2 arranged on the outer periphery of the expansion part 11 can conveniently realize the ablation operation of the target tissue. More importantly, the expansion part 11 can be provided in various shapes so as to adapt to the internal cavity diameter and shape of different respiratory tracts. On the basis, an electrode can be further arranged on the end face of the far end of the expansion part 11 so as to adapt to the ablation requirement of a specific part.

In the specific arrangement of the expansion part 11, referring to the embodiment shown in fig. 3a to 3b, in the expanded state, in the axial direction of the core tube 12, both ends of the expansion part 11 are closed, and the middle part is expanded to form a working area; the electrode 2 is mounted on the outer peripheral surface of the working area.

The expansion part 11 can control the expansion degree of the middle part through the distance between the two ends, so that the expansion part is linearly controlled, and the deformation process of the expansion part 11 is accurately controlled by operating personnel such as medical personnel. The electrode 2 is arranged on the peripheral surface of the working area, the working area is used as the part of the expansion part 11 with the largest radial size in the expansion state, the inner wall of the respiratory tract can be better attached, and the ablation operation can be conveniently realized.

In the embodiment disclosed with reference to fig. 3c, the expansion part 11 comprises a plurality of elastic rods 111, one end of each of the plurality of elastic rods 111 is connected in a converging manner, the other end is fixedly inserted into a distal portion of the core tube 12, and each of the electrodes 2 is fixed to a corresponding one of the elastic rods 111.

The elastic rod 111 provides a driving force for deformation of the expansion part 11. Since the member directly driving the expansion part 11 to deform has the largest stress among the members, the electrode 2 is provided on the elastic rod 111 to secure the position of the electrode 2 in the respiratory tract, and the success rate of the intervention is increased, thereby improving the treatment efficiency. In other embodiments, a plurality of electrodes may be disposed on the same elastic rod, and the cross-sectional shape of the elastic rod 11 is not limited, and may be circular, rectangular, or elliptical, and the elastic rod 11 itself may be either hollow or solid. For a certain elastic rod 11, a single rod body can be used, and a form of multi-strand twisting, or a form of combining a core wire with a spiral coating, etc. can also be used. The near ends of the elastic rods 111 converge and are fixedly inserted at the far end part of the core pipe 12, the far end part of the core pipe 12 can be elastically hooped, the near ends of the elastic rods 111 are bound and fixed in a welding mode and the like, a central supporting piece can be arranged for facilitating threading of parts such as a lead, the near ends of the elastic rods 111 converge and are close to the periphery of the central supporting piece, and the central supporting piece is provided with avoiding holes for threading of the parts such as the lead.

During the interventional and ablation procedures, the shape of the expansion 11 changes. In the embodiment disclosed with reference to fig. 3d, in the loaded state, the plurality of elastic rods 111 are bundled in parallel with each other; in the expanded state, each elastic rod is arc-shaped.

The elastic rods 111 bundled in parallel can provide smaller volume, and facilitate the implementation of the interventional procedure. Meanwhile, the parallel converging state reduces the deformation stress of the expansion part 11 in the road entering process, and the operation is convenient. The arc-shaped elastic rod can ensure that sharp appearance cannot be formed in the process of intervening in the human body, and unnecessary injury is avoided.

In the loaded state, the resilient rods extend substantially linearly and have a smaller overall outer diameter after collapse to provide passability.

In the specific arrangement position of the electrodes 2, in the embodiment disclosed with reference to fig. 3e, the electrodes 2 are mounted on the arc tips of the respective elastic bars 111.

The arc top portion is a portion where the amount of deformation of the elastic rod 111 is the largest. Electrode 2 installs and can change the deformation of inflation portion 11 into the change of electrode 2 relative position completely at the arc top position, consequently changeable respiratory tract of adaptation that can be better to satisfy complicated treatment demand. Under the inflation state, each elastic rod is the arc, can also understand the wavy structure that multistage arc concatenation formed, and the arc top position is probably more than a department, for example 2 ~ 3 departments in crest position, when setting up a plurality of electrodes on same elastic rod, each electrode sets up respectively in corresponding crest department.

In the spatial arrangement of the elastic rods 111, referring to fig. 4a, one end of each of the elastic rods 111 is connected to a connector 112, and in the expanded state, the elastic rods are radially distributed around the connector 112.

The relative distance between the connector 112 and the distal end of the core tube 12 controls the degree of deformation of the elastic member, and thus the degree of deformation of the expansion 11. Many elastic rods 111 are connected to connector 112, just can realize connector 112 to many elastic rods 111's synchro control, make things convenient for operating personnel such as medical personnel accurate and convenient control inflation portion 11 state in the human body, accurate realization melts the process. The elastic rod 111 with radiation distribution distributes the electrode 2 to the inner wall of the respiratory tract by radiation with the core tube 12 as the center, thereby conveniently and accurately realizing the ring ablation of the target point.

In the arrangement of the connection head 112, in the embodiment disclosed with reference to fig. 4b, the connection head 112 comprises:

a central block 1121, wherein the distal ends of the elastic rods 111 are gathered together and abut against the periphery of the central block 1121;

and a fastening cap 1122, wherein the fastening cap 1122 fastens and fixes the plurality of elastic rods 111 together with the central block 1121.

Through the setting of fastening cap 1122, the installation and the location of realization elastic rod 111 that can be convenient and firm reduce the requirement of production precision, improve production efficiency, reduction in production cost. The central block 1121, which is a biasing member for applying a biasing force to the elastic rod 111 to drive the elastic rod 111 to deform, can apply the same biasing force to the elastic rods 111 synchronously and equally, and facilitates control of the deformation process of the expansion portion 11 by an operator such as a medical worker.

Correspondingly, in the embodiment disclosed with reference to fig. 4b, the central block 1121 is provided with an adapting structure 1123 for connecting the pull core 4, and the pull core 4 is used for traction to change the posture of the expansion part 11.

The pull core 4 is used to drive the relative distance between the central block 1121 and the distal portion of the core tube 12, thereby applying a force to the elastic rod 111 to drive the elastic rod 111 to deform. The adaptive structure is disposed at a proximal side of the central block 1121, and is fixed to the central block 1121 in an integrated or separated manner, specifically, the adaptive structure may be a connecting hole, a hook, or the like, and a distal end of the pull core 4 may be inserted into and welded to the connecting hole, or tied and fixed to the hook.

In various embodiments, the pull core 4 has a solid structure or a hollow structure.

In the hollow structure, an auxiliary cooling medium passage is formed inside the core 4, and a cooling medium (e.g., physiological saline) can be introduced to form auxiliary cooling.

In a preferred embodiment, the central block 1121 may be provided with an opening connected to the auxiliary cooling medium passage for directly outputting the cooling medium, and a valve structure may be provided in the central block 1121 to control the on/off state of the auxiliary cooling medium passage.

The auxiliary cooling medium passage inside the core 4 also forms a loop for implementing the cooling by means of a circulating cooling medium, which may or may not be via the central block 1121.

In a particular arrangement, in the embodiment disclosed with reference to fig. 5, the plurality of resilient bars 111 is 3 in number and is a solid bar; in the embodiment disclosed with reference to fig. 3a, the number of the plurality of resilient bars 111 is 4 and is a hollow bar. There may be more combinations in a particular product, even where hollow and solid rods are mixed.

The more the number of the elastic rods 111 is, the more the corresponding positions where the electrodes 2 can be arranged are, so that the ring-shaped ablation on the target point can be realized more conveniently, but the difficulty of bending the distal end of the core tube 12 in the interventional procedure is increased by increasing the number of the elastic rods 111, and therefore, 3 or 4 elastic rods are preferred.

A single resilient rod 111, which may be a hollow rod or a solid rod, has different technical effects. For example, hollow rods can form channels inside for the threading of pipelines or the transport of fluids; for example, the solid rod can reduce the volume as much as possible under the condition of the same mechanical parameters, thereby providing better interventional effect. Therefore, the specific setting can be selected according to different use scenes or design requirements, and different structures can be mixed to meet special requirements.

In one embodiment, the elastic rods 111 are made of nitinol, and the elastic rods 111 are insulated from the electrode 2 by plating an insulating layer or wrapping an insulating tube.

The nickel-titanium alloy is convenient to perform, can be conveniently unfolded to a preset shape in a human body, and is convenient for operation of operators such as medical staff; the respiratory tract has changeable and complex shape, except the electrode 2 can contact with the inner wall of the respiratory tract, the elastic rod 111 can also contact with the inner wall of the respiratory tract, and therefore, the elastic rod 111 and the electrode 2 need to be arranged in an insulating way to avoid the damage to normal tissues.

In the embodiment disclosed with reference to fig. 6d, the electrode 2 is provided with an electrode slot 22 and is fixed to the corresponding elastic rod 111 by the slot.

The electrode 2 may be adhered to the tissue of the target during the ablation operation, and a certain connection strength needs to be maintained between the electrode 2 and the elastic rod 111 when the core tube 12 is moved, so that the electrode clamping groove 22 is preferably designed, and the stress performance of the electrode 2 in all directions can be structurally improved. The electrode clamping groove 22 can also prevent the electrode 2 from rotating around the elastic rod 111, so as to avoid unnecessary dislocation, in order to ensure the effect of preventing rotation and dislocation, at least a part of the matching part of the electrode clamping groove 22 and the elastic rod 111 is a plane in the preferred embodiment, and in addition, a positioning bulge and other structures can be arranged in the length direction of the elastic rod 111 to limit the slippage of the electrode 2.

The core tube 12 is used for transporting the cooling medium to the vicinity of the target point in addition to the electrode 2. The cooling medium can cool the tissues near the target point when the electrode 2 works, and the ablation effect is improved. In one embodiment, a plurality of delivery pipes are formed through the core tube 12 to respectively form delivery passages 13, and each delivery passage 13 supplies a cooling medium to one of the electrodes 2. The plurality of conveying pipelines can ensure the flow of the cooling medium when the plurality of electrodes 2 carry out ablation operation, and ensure the ablation effect. In one embodiment, each delivery line flow is independently controlled.

In some usage scenarios, the ablation parameters of each electrode 2 may need to be controlled independently, and the need for a cooling medium may also be inconsistent. The embodiment realizes accurate control of the cooling medium by independently controlling the flow of the delivery pipe. The regulation and control precision and the adaptability of the radiofrequency ablation catheter for implementing the pulmonary nerve ablation are improved, and the good ablation effect can be realized on target spots in different positions and under different conditions.

The independent control can be implemented in the prior art, for example by configuring the delivery pump and the corresponding control circuit separately for each delivery channel.

In one embodiment, each delivery tube is a separately configured tube or core 12 with its own plurality of channels, each delivery tube being provided by one of the channels.

The arrangement of the conveying pipe also has various advantages. For example, independently configured designs can provide greater flow, and are suitable for use in some usage scenarios where the cavity diameter is larger and the requirement for cooling medium flow is higher; furthermore, for example, a design scheme with multiple channels on the core tube 12 can provide a more regular external shape, and an interventional procedure can be conveniently realized in a narrow respiratory tract. The specific selection can be matched with other design schemes according to the requirements of the use scene.

When a plurality of cavities are adopted, the core tube can be integrally formed during processing, for example, a die head with a corresponding structure is adopted for extrusion molding, and the like.

The cooling medium needs to spread to function at the site where the electrode 2 achieves ablation. In the embodiment shown in fig. 6a to 6c, in the cooperation between the cooling medium and the electrodes 2, each electrode 2 is provided with a cooling medium channel and is in butt joint with a corresponding delivery pipe, and the output port 131 is provided on the outer surface of each electrode 2 and is communicated with the cooling medium channel inside the electrode 2.

The cooling medium directly diffuses from the electrode 2 to the target position, so that the cooling medium can be ensured to be synchronous with the position where ablation occurs, and the action effect of the cooling medium is improved. Meanwhile, the cooling medium flows through the electrode 2, so that the temperature difference between the tissues near the target point and the electrode 2 can be reduced, and the implementation of ablation parameter control means such as temperature control and the like is facilitated. In a practical application scenario, the cooling medium is generally conductive normal saline, and the normal saline diffused from the electrode 2 can also improve the ablation effect and optimize the ablation operation environment.

In a particular arrangement, in the embodiment disclosed with reference to figure 6a, the plurality of resilient bars 111 are solid bars and the distal portion of the delivery tube extends beyond the core 12 and along the respective resilient bars 111 until it abuts the electrode 2 on the resilient bars 111.

The conveying pipe is arranged along the elastic rod 111 and can better adapt to the deformation of the expansion part 11. Meanwhile, the elastic rod 111 is a force application member for driving the expansion part 11 to deform, so that the conveying pipe can be prevented from being deformed in a blocking manner under the action of external force, and the cooling medium can be stably conveyed to the electrode 2.

Reference is made to fig. 6d to 6f for an embodiment shown, where fig. 6e is a side sectional view of fig. 6d and fig. 6f is a top sectional view of fig. 6 d. The electrode 2 is provided with a butt joint socket 21 connected with the conveying pipe, the butt joint socket 21 is a tubular structure which can be integrated with the electrode or a split fixing structure, the butt joint socket 21 is provided with an annular bulge 211 for preventing the conveying pipe from dropping off, the inside of the electrode 2 forms a structure similar to a tee joint, and a cooling medium from the butt joint socket 21 is diffused to an ablation part through an output port 131 on the electrode 2.

In another embodiment, in order to facilitate the butt joint of each electrode 2 and the conveying pipe, the electrode 2 may be provided with a slot, the slot is communicated with a cooling medium flow passage inside the motor, and the end part of the conveying pipe is fixed in the slot. In one embodiment, the flexible rod 111 is provided with a sleeve 132, and the distal portion of the delivery tube extends out of the core tube 12 and into the sleeve 132 to the electrode 2.

To prevent tissue within the airway from affecting the delivery tube, the cannula 132 can form a relatively closed environment. Meanwhile, the sleeve 132 can also function as an insulating layer to prevent the RF energy on the electrode 2 from being transmitted to the normal tissue through the elastic rod 111.

In the embodiment disclosed with reference to fig. 6d, the output ports 131 on each electrode 2 are multiple and oriented differently.

The electrode 2 can diffuse in multiple directions when ablating the tissue of the target point, so the cooling medium needs to diffuse in multiple directions to ensure the ablation is orderly carried out. Therefore, the present embodiment realizes the diffusion of the cooling medium in different directions by setting the output ports 131 to have different orientations, and ensures the coverage area of the cooling medium. When the number of the output ports 131 on the electrode 2 is plural, the cooling medium flow passage inside the electrode 2 may adopt a branch structure, one end of each branch is linked with the delivery pipe, and the other end is communicated to the corresponding output port 131.

Other forms of cooperation of the cooling medium with the electrode 2 are also possible. In the embodiment disclosed with reference to fig. 7a to 7b, a plurality of conveying pipes are arranged in the core tube 12 to form the conveying channels 13, the plurality of elastic rods 111 are hollow rods, the proximal ends of the elastic rods 111 are communicated with a corresponding one of the conveying pipes, and the output port 131 is arranged on the elastic rod 111 and is communicated with the cavity 1111 of the elastic rod 111.

The elastic rod 111 is a hollow rod and can be used as a conveying pipe while ensuring the deformation of the elastic rod, so that the whole volume is reduced. More importantly, the elastic rod 111, which is a main structure forming component of the expansion part 11, is made of elastic material with high strength, and can provide high-strength conveying pipe performance without adding extra weight, and the condition of cooling failure caused by breakage of the conveying pipe and the like is avoided. In this embodiment, the cooling medium is transmitted through the cavity 1111 of the flexible rod 111, and the wires are still disposed along the outer side wall of the flexible rod 111 and protected by the sleeve 1112.

In the arrangement of the delivery openings, in the embodiment disclosed with reference to fig. 7c, the delivery opening 131 on the same flexible rod 111 and the electrode 2 are adjacent to each other, and the delivery opening 131 is on the distal side of the electrode 2.

The output 131 needs to diffuse the cooling medium to the tissue near the target point, so in this embodiment the output 131 is placed adjacent to the electrode 2. In another specific position, the output port 131 is located on the distal end side of the electrode 2 in this embodiment, in some other embodiments, the output port 131 may be disposed on the proximal end side of the electrode 2, or the output port 131 is disposed on both the distal end side and the proximal end side, and the specific requirement is set according to different requirements.

In terms of the selection of the number of the output ports 131, in an embodiment, a plurality of output ports 131 are arranged on the same elastic rod 111 and are arranged along the length direction of the elastic rod 111. For example, two or three output ports 131 are provided on the same resilient lever 111.

The increase of the number of the output ports 131 can effectively improve the diffusion effect of the cooling medium, so that the temperature of the target point can be stably and uniformly controlled, and stable ablation can be realized. In this embodiment, the arrangement of the output ports 131 in the length direction can further increase the coverage area of the cooling medium and optimize the diffusion effect.

The electrode 2 requires proximal delivery of radio frequency energy during ablation. Wires need to be arranged on the core tube 12. In the embodiment disclosed in fig. 7c, the flexible rod 111 is provided with a sleeve 1112, and the electrode 2 is connected with a first wire extending through the inside of the sleeve 1112 into the core tube 12 and extending proximally.

The lead is protected by the sleeve 1112 so as to avoid friction with the respiratory tract affecting the stability of the lead, which is important in the interventional field and often directly affects the efficacy of the treatment and the efficiency of the procedure. The sleeve 1112 may be preferably a PTFE shrink tube in material.

During the ablation procedure, the ablation status of the electrode 2 and the extent of ablation need to be controlled by a number of parameters. In one embodiment, the radiofrequency ablation catheter further comprises a plurality of temperature sensors, each temperature sensor being applied against or embedded in a respective electrode 2.

The temperature is a parameter which is easier to observe in the ablation operation and is directly related to the ablation process, and the ablation degree and the process can be directly controlled through the temperature sensor. The temperature sensor is attached to or embedded in the electrode 2, so that the ablation state of the electrode 2 can be detected more accurately. Meanwhile, the electrodes 2 are provided with temperature sensors independently, and a structural basis is provided for independently controlling the ablation parameters of the electrodes 2.

In one embodiment, a sleeve 1112 is disposed on each flexible rod 111, a second wire is connected to each sensor, and each second wire extends through the sleeve 1112 and into the core tube 12 and then extends proximally.

The second wire is protected by the sleeve 1112, so that friction between the second wire and the respiratory tract is prevented from influencing the stability of the second wire, the stability of reading of the temperature sensor is ensured, and the precision of ablation control is improved. The sleeve 1112 may be preferably a PTFE shrink tube in material. In connection with the previous embodiments, the first and second wires may be encased within the same sleeve 1112.

In addition to natural diffusion of the cooling medium when it is diffused to the target, the infiltration holes 51 may be designed to enhance the diffusion effect. Referring to fig. 8, in the embodiment, a plurality of wetting holes 51 communicated with the output ports 131 are distributed on the electrode 2, and the cooling medium from the output ports 131 is distributed to the periphery of the electrode 2 through the wetting holes 51.

The infiltration holes 51 can better diffuse the cooling medium to the target point, especially between the contact surface of the electrode 2 and the target point, thereby optimizing the ablation effect and facilitating the control of the ablation process.

A plurality of fine infiltration holes 51 are uniformly distributed on the electrode 2. The cooling medium enters the electrode 2 from the delivery pipe and flows out from the infiltration holes 51, and a thin cooling medium film in the form of a water film is formed on the outer surface of the electrode 2, so that the surface of the electrode is infiltrated by the cooling medium (in this embodiment, the cooling medium is normal saline), ablation tissue scabbing is further avoided, and loop impedance is reduced. Maintaining impedance balance allows the ablation process to continue until the target ablation volume is reached.

The pore size and density distribution of the wetting holes 51 can be set according to the flow demand of the heat exchange medium, so as to ensure that a uniform protective film is formed on the periphery of the electrode as much as possible, for example, all the wetting holes 51 have the same pore size, or are set according to the flow balance of the heat exchange medium.

I.e., the size of the wetting holes 51 in different areas can be varied to accommodate the need for uniform flow. In the same way, the distribution density of all the infiltration holes 51 at different parts of the equalizing device is the same, or the infiltration holes are arranged correspondingly according to the flow balance of the heat exchange medium.

When the heat exchange medium flow rate is balanced and correspondingly set, the arrangement mode of the heat exchange medium flow channel outlet is mainly considered, for example, the aperture of the wetting hole 51 increases with the distance from the outflow hole.

Similarly, for example, the distribution density of the wetting holes 51 increases with distance from the outlet holes.

The wetting holes 51 may be arranged as desired during processing, for example, in one embodiment, the wetting holes 51 are distributed in a plurality of groups along the circumference of the electrode 2.

In one embodiment, the expansion portion 11 includes a plurality of elastic rods 111, one end of each of the plurality of elastic rods 111 is connected in a converging manner, the other end of each of the plurality of elastic rods 111 is fixedly inserted into a distal portion of the core tube 12, and each of the electrodes 2 is fixed to a corresponding one of the plurality of elastic rods 111.

The electrode 2 is fixed on the elastic rod 111, so that the electrode 2 can be attached to the elastic rod, the radial volume can be reduced when the elastic rod is contracted, and the threading and the intervention are facilitated.

Specific structure of the electrode 2, in the embodiment disclosed with reference to fig. 10, the electrode 2 is a closed structure in the circumferential direction of the elastic rod 111.

Accordingly, in one embodiment, the electrode 2 is in a non-closed configuration around the circumference of the flexible rod 111. The electrode 2 with the closed structure can ensure a good connection relation with the elastic rod 111, and can provide enough strength in some treatment scenes in which the electrode 2 needs to be in stressed contact with the tissues of the respiratory tract. The selection of a particular electrode 2 can be selected as desired depending on the use scenario and design criteria.

In one embodiment, the electrodes 2 are provided with distribution grooves (not shown) for the passage of the cooling medium, and the cooling medium from the outlets 131 is supplied to the wetting holes 51 at the outer periphery of the respective electrodes 2 through the distribution grooves.

In a specific using method, the radiofrequency ablation catheter for performing pulmonary nerve ablation disclosed by the application establishes an interventional passage through a bronchoscope, after the bronchoscope reaches a focus (namely a target point), a sheath tube 3 with a core tube assembly 1 is plugged into the bronchoscope, an adjustable knob is twisted, a pull core 4 is loosened, the expansion part 11 is contracted and gathered to enter a loading state, the core tube assembly 1 is pushed, the expansion part 11 passes through the bronchoscope from the sheath tube 3, after the expansion part 11 passes through the bronchoscope, the expansion part 11 is observed through the bronchoscope, a handle at the near end is rotated to adjust the position of an electrode 2, after the adjustment is completed, the adjustable knob is rotated, the pull core 4 is pulled, the expansion part 11 is driven to enter the expansion state, the expansion part is expanded until the electrode 2 is well attached to the inner wall of a bronchus, then a cooling medium is introduced, cold saline is adopted in the embodiment, then the radiofrequency instrument is opened, and the plurality of electrodes 2 are ablated at the same time (the cold saline pump, if the temperature is higher than 60 ℃, the saline flow rate is increased, if the temperature is not higher than 60 ℃, the flow rate is kept unchanged, the saline flow rate is adjusted within the range of 3-15 ml/min), the ablation power range is 3-10W, the ablation time is 60s-120s, the bronchoscope is matched with and pumps out redundant saline in the cavity channel during ablation, after ablation is completed, the pull core 4 is loosened through the adjustable knob, the expansion part 11 naturally enters a loading state by means of the self elasticity of the elastic rod 111, the ablation position is adjusted, the next round of ablation is carried out, and finally a closed loop is formed at the ablation point on the inner wall of the main bronchus. If the ablation point is observed through the bronchoscope and the ablation point is not closed, the expansion part 11 is adjusted to enable one electrode 2 to be in the gap position, and the monopolar ablation is carried out until the ablation point forms a closed loop.

The expansion 11 can have other designs besides the net cage shape, and in the embodiment disclosed with reference to fig. 9a to 9b, the core tube assembly 1 comprises a core tube 12, and the distal end portion of the core tube 12 constitutes the expansion 11, the expansion 11 having opposite loading and expansion states, in which the expansion 11 is in the shape of a closed or open loop; the electrodes 2 are arranged at intervals on the expanded portion 11 in the extending direction of the core tube 12. Referring to fig. 9 a-9 b, the ring size differences are compared. The annular shape has an advantage in that the diameter of the annular shape itself can be changed to realize the function of the expansion part 11. Because the stress direction of the self deformation of the annular expansion part 11 is radial on the section of the far end, the bending of the core pipe assembly 1 in the intervention process cannot be influenced, the respiratory tract position with smaller cavity diameter can be more conveniently entered, and the fine operation is convenient. Meanwhile, the expansion part 11 may be formed by bending the distal end of the core tube 12, and the entire structure is more complete.

Different designs of the expansion part 11 have different advantages, for example, the expansion part 11 in the shape of a net cage has simple structure and reliable support, can be realized by the existing materials and technologies, has low manufacturing cost and is easy to popularize; the annular expansion part 11 has small circle diameter, can realize the ablation of respiratory tracts with different cavity diameters, has small self deformation stress, is convenient to implement in the intervention process, and can realize more accurate ablation. Therefore, the design scheme disclosed by the application can be adjusted as required according to different treatment scenes and use requirements, the adaptability of the radiofrequency ablation catheter is improved, the operation of medical personnel is facilitated, and the experience of a patient in the treatment process is improved.

In the embodiment disclosed with reference to fig. 10a, the core tube 12 is provided with a plurality of channels, one of which is the first channel 113 and serves as the conveying passage 13, and the output ports 131 are formed in the side wall of the core tube 12 and are communicated with the first channel 113.

The core tube 12 can function to protect the conveyance channel 13. The core tube 12 is made of a material having high strength, and can effectively prevent the cooling failure caused by the breakage of the conveyance passage 13. Meanwhile, because the expansion part 11 and the core tube 12 can adopt an integrated design, the cooling medium is directly transmitted to the vicinity of the electrode 2 from the conveying channel 13 in the core tube 12, and the structure is simple and stable.

In one embodiment, the electrode 2 is sleeved on the corresponding output port 131, and a plurality of wetting holes 51 communicated with the corresponding output port 131 are formed on the electrode 2.

Besides natural diffusion when the cooling medium diffuses to the target point, the diffusion effect can be improved by designing the output ports 131 more frequently. In this embodiment, the cooling medium at the output port 131 is better diffused to the target point through the plurality of infiltration holes 51, especially between the contact surface of the electrode 2 and the target point, so as to optimize the ablation effect, prevent the tissue from scabbing in the ablation process, and facilitate the control of the ablation process.

In one embodiment, each electrode 2 is a cylindrical shape closed in the circumferential direction or a C-shape partially opened.

The electrode 2 is fixed to the expansion portion 11 and needs to have a certain strength. In some treatment scenarios, adhesion may occur between the electrode 2 and the ablated tissue, and the electrode 2 is subjected to a pulling force when the rf ablation catheter is moved. The cylindrical or C-shaped electrode 2 can ensure the structural strength and avoid the accidental situations such as the falling off of the electrode 2. Meanwhile, the C-shaped electrode 2 also has the advantage of convenience in installation, can reduce the production cost, and can be applied to products in some treatment scenes.

In one embodiment, the outer wall of the core tube 12 is provided with a distribution groove (not shown) communicating with the output ports 131, through which the cooling medium from the output ports 131 is supplied to the wetting holes 51 on the respective electrodes 2.

The function of the distribution groove is to pre-distribute the cooling medium, thereby improving the diffusion effect of the cooling medium. If the cooling medium is simply supplied to the wetting holes 51 through the output ports 131, more cooling medium may be obtained for the wetting holes 51 of the output ports 131, and the cooling medium diffusion effect may be poor. In an actual product, the distribution groove can be operated by changing the shape of the output opening 131.

The electrode 2 requires proximal delivery of radio frequency energy during ablation. Wires need to be arranged on the core tube 12. In the embodiment disclosed in fig. 10a, one of the plurality of channels is a second channel 114, and each electrode 2 has a first lead wire connected thereto, and each first lead wire extends through the sidewall of the core tube 12 into the second channel 114 and extends proximally.

The first wire is protected by the core tube 12 so as to avoid friction with the respiratory tract affecting the stability of the wire, which is important in the interventional field and often directly affects the efficacy of the treatment and the efficiency of the operation.

In one embodiment, the radiofrequency ablation catheter further comprises a plurality of temperature sensors, each temperature sensor being attached to or embedded in a corresponding electrode 2;

a second wire is connected to each sensor and extends proximally through the sidewall of the core tube 12 into the second lumen 114 or into a separately disposed third lumen.

In the path of the second conductive line, the second channel 114 can be selected to be shared with the first conductive line or the third channel can be configured independently, so that in some special scenarios, the rf energy of the first conductive line may interfere with the second conductive line.

In the embodiment disclosed with reference to fig. 10a, one of the plurality of channels is a wire channel for disposing a wire (not shown) connected to the expansion part 11 to change the posture of the expansion part 11, i.e., to adjust the degree of bending of the expansion part 11, and the wire channel is shared with the second channel 114 or shared with the third channel or disposed separately.

The shared use of the wire-drawing lumen and other lumens can effectively reduce the radial size of the core tube 12, and facilitate the implementation of the interventional procedure. At the time, the other pipelines are not moved, and the pull wire moves relative to the core tube 12, so that relative interference may be generated between the pull wire and the other pipelines, and in some scenes with high requirements on the movement precision of the pull wire, the cavity channel can be configured independently. In this embodiment, the first and second leads share a second lumen 114, and the puller wires are individually configured with puller wire lumens.

In the embodiment disclosed with reference to fig. 10b, the distal end of the pull wire lumen extends to the tip region of the core tube 12.

The pull wire needs to operate the expansion 11 and thus needs to extend to the distal end of the core tube 12. To avoid interference of the puller wire by other components of the rf ablation catheter or by tissue in the respiratory tract, a puller wire lumen is also disposed to the distal end of the core tube 12 to protect the puller wire. In the actual product, the swelling portion 11 is formed by the distal end portion of the core tube 12, so that the wire lumen is arranged in the core tube 12 up to the tip of the core tube 12, thereby achieving control of the tip of the swelling portion 11. In the actual product, the end of the expansion part 11 is provided with an end cover 115, and the stay wire is fixed on the end cover 115.

The deformation process of the expansion part 11 is controlled by the stay wire on one hand and is realized by the elasticity of the expansion part on the other hand. In order to ensure stability of the state transition, in an embodiment, a shaping element (not shown) is provided in the core tube 12, which shaping element is arranged to maintain the position of the expansion 11 in the released state.

In the free state of the stay wire, the expansion part 11 is kept in the release state under the action of the shaping piece, and the loop diameter is maximum in space, so that the ablation operation is conveniently implemented; when the stay wire is tightened, the elasticity of the plastic part is overcome to drive the expansion part 11 to reduce the self space volume so as to facilitate the implementation of the intervention process, and the tightening degree of the stay wire is related to the space volume of the expansion part 11, so that the near end can accurately control the space state of the expansion part 11.

The mounting of the shaping element can be of various forms. In one embodiment, the shaping member is secured to the inner wall of the core tube 12. In one embodiment, the shaping member is inserted and fixed into the sandwich of the wall of the core tube 12. In other embodiments, the shaping member may be affixed to the outer wall of the core 12. (not shown in the figure)

The core function of the shaping piece is to drive the expansion part 11 into a release state and drive the electrode 2 to be close to the tissue from the target point so as to realize ablation, so that the specific installation position can be set according to the design index and the condition of the internal components of the radio frequency ablation catheter.

In one embodiment, the shaping member is a nickel titanium alloy.

The nickel-titanium alloy has the characteristics of good elasticity, high stability and convenience for processing and shaping. The performance requirements of the plastic part in the embodiment are met.

Aiming at the situation that the esophagus needs to be avoided when the left and right main branches are ablated, the electrode 2 is arranged on the arrangement details of the expansion part 11, and in the embodiment disclosed by referring to fig. 10b, the expansion part 11 is in an open ring shape, one end is a tail end, the other end is a starting end, and the starting end is connected with the other part of the core tube 12; the part of the expansion part 11 adjacent to the tail end is a regulation section 14, the rest parts are working sections, and the electrodes 2 are distributed on the working sections and avoid the regulation section 14.

The expansion part 11 is in an open ring shape, and has the advantage of providing a larger deformation stroke to adapt to target points with different cavity diameters. This embodiment is implemented by the arrangement of the electrodes 2 distributed over the working section in order to avoid the esophagus. In the selection of specific parameters, in an embodiment, the central angle corresponding to the working segment is greater than or equal to 270 degrees.

When aiming at the branch in the deeper position, the side does not need to consider avoiding problem, at this moment, the electrodes 2 can be uniformly distributed on the expansion part 11, namely, the tail end part can also be provided with an electrode.

In one embodiment, there are four electrodes 2.

The increase in the number of electrodes 2 is more convenient for ablation to form a closed loop, but the more lines there are in the core tube 12, the more the corresponding bending and other operations are required during intervention, and in the present embodiment, the number of electrodes 2 is preferably four when the two are combined with the requirements of the existing treatment environment.

In the arrangement of the electrode 2, the electrode 2 is not formed with a projection with respect to the expansion part 111, and the outer diameter is in conformity with the expansion part 111, so that the electrode can be smoothly pushed out in a uniform tubular structure in the loaded state.

In a specific operation process, referring to fig. 14, the radiofrequency ablation catheter for performing pulmonary nerve ablation disclosed by the present application establishes an intervention path through the bronchoscope 7, the sheath 3 is preset in the bronchoscope 7, and after the bronchoscope 7 reaches a lesion (i.e., target point) position, an operator straightens the expansion part 11 through the protection tube 15 to enter a loading state, so that the expansion part 11 enters the sheath 3. During the course of passing through the sheath 3, the expansion part 11 is kept in a straightened loading state until reaching the lesion site from the distal end of the sheath 3. After the expansion part 11 penetrates out of the sheath tube 3, the self ring shape can be recovered through self deformation or stay wire drive and other forms, so that the expansion part enters a release state, and the implementation of a treatment process is facilitated.

It should be noted that if the expansion part 11 is provided in a ring shape and the pull wire is provided, the operation of straightening the expansion part 11 by the protective tube 15 should be performed in a state where the pull wire is loosened, and the loop diameter of the expansion part is the largest, i.e., the most loose state, otherwise there is a risk of breaking the pull wire.

In some embodiments, the diameter of the ring can be further adjusted by twisting the force application member 64 to drive the pull wire, so as to adjust the size of the ring diameter of the expansion part 11. While also enabling adjustment of the electrode 2 position by actuating a proximal handle. In the adjustment process, an operator can observe the expansion part 11 through the bronchoscope 7 until the electrode 2 can be well attached to the inner wall of the lesion.

Then, a cooling medium is introduced, in this embodiment, cold saline is adopted, then the radiofrequency instrument is turned on, the plurality of electrodes 2 perform ablation simultaneously (the cold saline pump should adjust the flow rate according to the ablation temperature of the radiofrequency instrument, if the temperature is higher than 60 ℃, the saline flow rate should be increased, the temperature does not exceed 60 ℃, the flow rate is kept unchanged, the saline flow rate is adjusted within the range of 3-15 ml/min), the ablation power range is 3-10W, the ablation time is 60s-120s, the bronchoscope is matched with and pumps out redundant saline in the lumen during ablation, after ablation is completed, the pull wire is tightened through the force application part 64, the loop diameter of the expansion part 11 is adjusted to conveniently adjust the ablation position, next round of ablation is performed, and finally, a closed loop is formed at the ablation point on the inner wall of the focus. If the ablation point is observed through the bronchoscope and the ablation point is not closed, the expansion part 11 is adjusted to enable one electrode 2 to be in the gap position, and the monopolar ablation is carried out until the ablation point forms a closed loop.

With reference to fig. 11a to 11c, the present application further discloses a radiofrequency ablation catheter for performing pulmonary nerve ablation, which includes a sheath tube 15 slidably sleeved on the radiofrequency ablation catheter, and a handle 61 connected to a proximal end of the radiofrequency ablation catheter, wherein the expansion portion 11 of the radiofrequency ablation catheter can be folded in the sheath tube 15;

the handle 61 is provided with a tubing connector 611 which is communicated with the delivery channel, and a circuit connector 612 which is connected with the circuit elements in the radiofrequency ablation catheter through wires.

The radio frequency ablation system in the embodiment establishes the access path through the bronchoscope, the respiratory tract is greatly different from other access paths, and the change degree of the cavity paths of other access paths is less; while the airway lumen diameter varies to a greater extent. Therefore, the radiofrequency ablation catheter realizes the treatment of different target positions through the core tube assembly with the expansion part. The expansion portion is capable of changing its loop diameter, thereby matching the impedance of electrodes disposed on the expansion portion near the target site to respiratory tracts of different lumen diameters. When the protection tube 15 slides, the expansion part 11 can be stroked and stored in the protection tube, when the protection tube 15 is used, the protection tube 15 is butted with the near end of the sheath tube 3, and then the radiofrequency ablation catheter is communicated with the expansion part 11 and pushed into the sheath tube 3.

In one embodiment, the proximal end of the rf ablation catheter is further sleeved with a stress relief tube 6, the stress relief tube 6 is fixed to the handle 61 in such a manner that the handle 61 has a threading channel 613 passing through axially, the distal end of the handle 61 is provided with a plurality of elastic clamping jaws 614, and the proximal end of the stress relief tube 6 is inserted into the threading channel 613 and is tightly fixed by the plurality of elastic clamping jaws 614; the plurality of resilient clamping jaws 614 cooperate to clamp and secure the stress relief tube 6 therebetween by means of a threaded engagement of a tightening nut 615.

In one embodiment, the radiofrequency ablation catheter further comprises a pull wire for changing the posture of the expansion part, and the handle 61 is provided with a pull wire adjusting mechanism connected with the pull wire.

The function of the stay wire adjusting mechanism is to apply a pulling force to the stay wire, and the stay wire is used as a flexible component and can transmit the self pulling force to the other end, namely the expansion part. The expansion part can generate preset deformation under the action of the stay wire, so that the spatial position of the electrode at the far end is adjusted, and the requirement of ablation is met.

In one embodiment, the wire adjustment mechanism includes:

a guide 62 fixedly connected to the handle 61;

a traction member 63 connected to the wire and slidably mounted on the guide member 62;

the urging member 64 is rotationally engaged with the guide member 62, and rotationally drives the pulling member 63 to linearly reciprocate.

The force applying member 64 is formed to move in a direction of rotation of the guide member 62 by the force applying member 64, so that the force applying member 64 itself makes a linear reciprocating motion to apply a force to the wire by the pulling member 63 on the premise that the guide member 62 and the handle 61 are relatively fixed. The design has the advantage that stable acting force can not be applied to the stay wire, and more importantly, stable fine adjustment can be carried out on the acting force of the stay wire.

In one embodiment, the guiding element 62 includes a tube body, the pulling element 63 is located inside the tube body, the force applying element 64 is rotatably sleeved outside the tube body, a guiding hole 621 is formed in the tube wall and is disposed along an axis of the guiding element 62, and a portion of the pulling element 63 extends out of the guiding hole 621 and is linked with the force applying element 64.

In principle, the three components of the guiding component 62, the pulling component 63 and the force applying component 64 are required to be stably driven and not generate clamping stagnation, so that the guiding ports 621 and the like are required to be arranged to guide the moving direction of the pulling component 63, and the phenomenon that the clamping stagnation is generated in the compact space layout to influence the treatment process is avoided.

In one embodiment, the inner wall of the force applying member 64 is formed with a spiral groove 641, and the portion of the pulling member 63 extending out of the guiding hole 621 is engaged in the spiral groove.

The spiral groove functions to convert the rotation of the force application member 64 into the reciprocation of the wire, and is a structure for changing the moment. The design has certain requirements on the pitch and the stroke of the spiral, and the self-locking is required to ensure that the stay wire cannot displace in the using process.

In one embodiment, the pulling member 63 includes:

a traction body 631 slidably arranged within the tube body;

a radial rod 632 fixed on the traction body 631 and extending out of the guide hole 621 to match with the spiral groove;

an anchor head 633 fixedly embedded in the traction body 631, the proximal end of the pull wire being connected to the anchor head 633.

The traction member 63 needs to have a good mechanical property as a structure for directly transmitting torque with the wire. Meanwhile, the spiral groove needs to be matched, so that the clamping condition under the stress condition cannot be generated, and the design is needed on the self shape, such as a round shape and the like.

In one embodiment, the guiding element 62 is a multi-petal structure that radially and mutually snap-fits, and at least one petal is fixed relative to the handle 61 and detachably snap-fits with the rest petals.

The multi-lobe structure can improve the stability of the installation of the two. Compared with other installation modes, the multi-petal structure also has the effect of improving the assembly precision under the condition of not improving the assembly difficulty, so that the influence on the operation process caused by some unnecessary errors can be avoided.

In one embodiment, the guide 621 is provided at the split of the adjacent petals.

The guide hole 621 is formed at the splicing portion of the adjacent petals to prevent stress concentration caused by the movement of the wire, thereby providing a smoother movement performance of the wire. The guide hole 621 of the split part of the adjacent petals is easy to realize from the aspect of processing and installation.

In one embodiment, the towing member 63 defines an evacuation passageway and an evacuation through-hole 634 for evacuating the guide wire.

The pulling element 63 acts directly on the wire and therefore needs to maintain at least a portion of the axial distribution of the wire and therefore is easily accessible to the coaxial conductors or feed channels, the provision of the through hole enables an efficient distribution of the internal structure and thus a reduction in the overall bulk.

In one embodiment, the radiofrequency ablation system further comprises a generator connected to each electrode in the radiofrequency ablation catheter for sending a corresponding energizing drive signal, and a cooling medium delivery device for providing a cooling medium to each of the plurality of electrodes.

During ablation, a cooling medium needs to be delivered. The cooling medium can prevent the target tissue from being over-heated in the ablation process to influence the treatment effect. In the embodiment, the output ports of the plurality of electrodes are independently designed, so that the ablation parameters of the plurality of electrodes are independently controlled. The electrodes are provided with independent output ports, so that a structural basis can be provided for independently controlling ablation parameters by a single electrode, and a better ablation effect can be achieved.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features. When technical features in different embodiments are represented in the same drawing, it can be seen that the drawing also discloses a combination of the embodiments concerned.

The above-mentioned embodiments only express several embodiments of the present application, and the description thereof is more specific and detailed, but not construed as limiting the claims. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the concept of the present application, which falls within the scope of protection of the present application. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. A method of controlling a radio frequency ablation system for performing pulmonary nerve ablation, the pulmonary nerve ablation system including at least one electrode for delivering energy, a temperature sensor for collecting temperature information at a location of each electrode, and a cooling medium delivery device for providing a cooling medium to each electrode, the method comprising, for each electrode:

2. The method of claim 1, wherein the temperature threshold is 55-65 ℃, and the flow rate of the cooling medium is increased when the temperature information is higher than the temperature threshold, and otherwise the current flow rate is maintained.

3. The method for controlling a radio frequency ablation system for pulmonary nerve ablation according to claim 2, wherein the flow rate of the cooling medium is adjusted in a range of 3-15 ml/min.

4. The method of controlling a radiofrequency ablation system that performs pulmonary nerve ablation of claim 3, further comprising:

5. The method of claim 4, wherein the power of the electrode is adjusted in a range of 3-10W.

6. The method of controlling a radio frequency ablation system according to claim 1, further comprising monitoring the ablation time, wherein the ablation is terminated when the ablation time reaches 60-120 s.

7. A radio frequency ablation system for performing pulmonary nerve ablation, the radio frequency ablation system including at least one electrode for delivering energy, the radio frequency ablation system further comprising:

8. A radio frequency ablation system for performing pulmonary nerve ablation comprising a processor and a memory, the memory having a computer program stored therein, the processor when executing the computer program performing the steps of:

9. A method of controlling a pulmonary nerve ablation system including at least one electrode for discharging energy and a cooling medium delivery device for supplying a cooling medium to the respective electrode, the method comprising, for each electrode:

10. The method of claim 9, further comprising pre-calibrating the steady-state impedance, and calculating a threshold value based on the steady-state impedance, the threshold value being used to compare with the impedance information to generate a corresponding adjusted cooling medium flow.

11. The method for controlling the pulmonary nerve ablation system according to claim 10, wherein the steady-state impedance is calibrated in such a way that after the radiofrequency ablation catheter is in place in the body and before the electrodes are energized, the heat exchange medium is output at an initial flow rate, impedance information is collected in real time, and when the impedance information is stable, the corresponding value is recorded as the steady-state impedance.

12. The method for controlling the pulmonary nerve ablation system according to claim 9, wherein the step S210 of generating a corresponding control command according to the impedance information specifically includes:

13. The method for controlling a pulmonary nerve ablation system according to claim 12, wherein the threshold is a range of values, and the step S211 of determining the increase or decrease of the flow rate according to the relationship between the impedance information and the threshold specifically includes:

14. The method of controlling a pulmonary nerve ablation system according to claim 13,

executing step S200 and step S210 circularly according to the sampling period of the impedance information;

15. The method of controlling a pulmonary nerve ablation system according to claim 14,

after a first control instruction is generated and output in the last sampling period, in the next period, comparing impedance information with impedance information in the last sampling period before comparing the impedance information with a threshold value, and judging the change trend of the impedance information;

16. The method of controlling a pulmonary nerve ablation system according to claim 14,

after a second control instruction is generated and output in the last sampling period, in the next period, comparing the impedance information with the impedance information in the last sampling period before comparing the impedance information with a threshold value, and judging the change trend of the impedance information;

17. A pulmonary nerve ablation system comprising at least one electrode for releasing energy, characterized in that the pulmonary nerve ablation system further comprises:

18. A pulmonary nerve ablation system comprising a processor and a memory, the memory having a computer program stored therein, the processor when executing the computer program performing the steps of:

and acquiring impedance information of an electrode working circuit, and sending a corresponding energy release driving signal to the electrode according to the impedance information.