WO2024149191A1 - Ablation device for airway tissue, system and control method - Google Patents

Abstract

Provided by the present invention is an ablation device for airway tissue, comprising: an air source, a freezing medium reservoir, a heat exchange system, a catheter and a control system. The heat exchange system comprises a thermal refrigerator and connecting pipes. The thermal refrigerator is provided inside of the freezing medium reservoir. The connecting pipes comprise a first connecting pipe and a second connecting pipe. A proximal end of the first connecting pipe is connected to a distal end pipe of the air source, and a distal end of the first connecting pipe is connected to a proximal end pipe of the thermal refrigerator. A proximal end of the second connecting pipe is connected to a distal end pipe of the thermal refrigerator. The catheter comprises an air inlet tube and a freezing probe. A proximal end of the air inlet tube is connected to a distal end pipe of the second connecting pipe. A proximal end of the freezing probe is connected to a distal end pipe of the air inlet tube. The control system comprises an input regulator, a freezing medium reserve monitor and an industrial personal computer. Further provided by the present invention is an airway spray cryoablation system. According to the present invention, by means of monitoring and determination by the control system, the input pressure of the thermal refrigerator is automatically and precisely regulated, thereby precisely controlling the output of the cooling amount.

Description

Airway tissue ablation device, system and control method

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the priority of the Chinese patent application filed with the Chinese Patent Office on January 9, 2023, with application number 202310027496.0 and invention name “A device for ablation of airway tissue” and the Chinese patent application filed with the Chinese Patent Office on January 10, 2023, with application number 202310034944.X and invention name “A system for spray cryoablation of airway”, the entire contents of which are incorporated by reference into this application.

Technical Field

The present invention relates to the field of cryoablation technology, and in particular to an airway tissue ablation device and a control method thereof, and an airway spray cryoablation system.

Background technique

At present, there are more and more patients suffering from chronic airway diseases at home and abroad, and the disease progresses faster and faster. Traditional treatment methods are still mainly based on drug therapy, which has the main disadvantages of many complications, heavy drug burden, and poor drug compliance.

Interventional treatments for respiratory diseases are constantly improving and being promoted. In the field of interventional treatments for respiratory diseases, cryotherapy is used for benign and malignant tumors, airway stenosis, chronic obstructive pulmonary disease, asthma, bronchial tuberculosis, and hemostasis. There are fewer complications of intrabronchial cryotherapy, and the main common complications are tissue edema after freezing and tearing of tissues after cryosection with a small amount of bleeding. The corresponding treatment measures are mature.

Existing ablation devices and systems generally use metal probes as the freezing end, which has defects such as small freezing range, high freezing temperature, and low freezing efficiency, making it difficult to apply to large-area cryoablation in the airway. At present, there are also cryo-spray systems used in airway diseases, but their control performance on liquid nitrogen output is poor, and the catheter does not have good thermal insulation performance, which will cause ice and frost in the non-freezing area, causing frostbite risks to doctors and patients and freezing damage to the supporting equipment. At the same time, because the catheter is not well insulated, the catheter and the supporting equipment are bonded together after freezing, and the equipment cannot be used normally during this period, resulting in high safety risks. In addition, there are defects such as slow cooling rate and high freezing temperature.

Summary of the invention

The purpose of the present invention is to address the deficiencies in the prior art and to provide an airway tissue ablation device and a control method thereof, as well as an airway spray cryoablation system.

To achieve the above object, the technical solution adopted by the present invention is:

The present invention provides an ablation device for airway tissue, comprising: an air source, a cryogenic medium storage device, a heat exchange system, a catheter, and a control system. The heat exchange system comprises a heat cooler and a connecting pipeline. The heat cooler is arranged in the cryogenic medium storage device. The connecting pipeline comprises a first connecting pipeline and a second connecting pipeline. The proximal end of the first connecting pipeline is connected to the distal pipeline of the air source, and the distal end of the first connecting pipeline is connected to the proximal end pipeline of the heat cooler. The proximal end of the second connecting pipeline is connected to the distal pipeline of the heat cooler. The catheter comprises an air inlet pipe and a cryogenic probe. The proximal end of the air inlet pipe is connected to the distal pipeline of the second connecting pipeline. The proximal end of the cryogenic probe is connected to the distal pipeline of the air inlet pipe. The control system comprises an input regulator, a cryogenic medium reserve monitor, and an industrial computer. The input regulator is arranged on the first connecting pipeline. The cryogenic The medium storage monitor is arranged on the refrigerating medium storage device. The industrial computer is electrically connected to the input regulator and the refrigerating medium storage monitor respectively.

The present invention also provides an airway spray cryoablation system, comprising: the above-mentioned airway tissue ablation device and a lifting system. The lifting system comprises: a lifting power device connected to the industrial computer, and a lifting component; the lifting component is connected to the lifting power device and the thermal cooler respectively, and is used to control the contact area between the thermal cooler and the freezing medium in the freezing medium storage device.

The present invention also provides a control method for an ablation device, which is used to control the above-mentioned ablation device, and the control method includes: turning on the power, system self-checking, and if there is an abnormality, performing system debugging, and then performing self-checking after debugging; if it is normal, entering the freezing mode; setting the points that need to be frozen, determining the cold amount corresponding to the freezing points, and adjusting the input pressure according to the initial freezing medium reserves; using a compensation mechanism to adjust the input pressure in real time according to the changes in the freezing medium reserves, and performing cold amount compensation by increasing the input pressure; monitoring the freezing medium reserves, the output temperature of the refrigerant, the output temperature of the catheter, the vacuum degree of the system, and the required freezing time; the monitored information is fed back to the compensation mechanism and the judgment mechanism in real time; if an abnormality occurs during the process, the freezing is suspended and the system self-check is performed again; using a judgment mechanism to judge the input cold amount, if it is determined that the real-time input cold amount does not meet the set range, it is fed back to the compensation mechanism, and the compensation mechanism adjusts the input cold amount in combination with the information of the monitoring system and the judgment system; if the real-time cold amount exceeds the safety range, pressure relief is performed.

The present invention adopts the above technical solution, and has the following technical effects compared with the prior art:

The airway tissue ablation device and airway spray cryoablation system of the present invention will consume the cryogenic medium reserve as they operate, and the output of cold will also change accordingly, the liquid level will drop, and the contact area will be reduced. Through the monitoring and judgment of the control system, the pressure input into the heat refrigerator is automatically and accurately adjusted according to the cold reserve for compensation, thereby accurately controlling the output of cold; the lifting component is adjusted in real time to keep the contact area constant. An insulating layer is provided outside the air inlet pipe, and real-time vacuum monitoring is provided, so that the cold is not disturbed by the external environment during transportation, the accuracy of cold transportation is improved, and the non-freezing area is protected from damage to medical staff, patients or supporting equipment; the freezing probe has an adaptive centering function to ensure that the freezing probe is located in the center of the airway when liquid nitrogen is sprayed, thereby improving the uniformity of freezing, and the flexible material further improves the application performance of the catheter in the endoscope.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG1 is a schematic structural diagram of an airway tissue ablation device according to the present invention;

FIG2 is a schematic diagram of the structure of the air inlet tube in the ablation device;

FIG3 is a schematic diagram of the structure of a cryoprobe in an ablation device;

FIG4 is a schematic diagram of the structure of a heat insulation layer in an ablation device;

FIG5 is a schematic diagram of the structure of a heat insulation layer in an ablation device;

FIG6 is a schematic diagram of the structure of a heat insulation layer in an ablation device;

FIG7 is a schematic diagram of the structure of an air inlet connector, a vacuum connector, and a vacuum connecting tube in the ablation device;

FIG8 is a schematic diagram of the structure of a cryoprobe extension tube and an extension tube marker ring in the ablation device;

FIG9 is a schematic diagram of the structure of a centering device and a marker ring of the centering device in the ablation device;

FIG10 is a schematic diagram of the structure of a thermocouple in an ablation device;

FIG11 is a schematic diagram of the structure of a thermocouple in an ablation device;

FIG12 is a schematic diagram of the structure of a thermocouple in an ablation device;

FIG13 is a schematic diagram of the control flow of the ablation device in the present invention;

FIG14 is a schematic diagram of the use of the ablation device of the present invention;

FIG15 is a schematic diagram of a bronchus when the ablation device of the present invention is used;

FIG16 is a schematic diagram of the lungs when the ablation device of the present invention is used;

FIG17 is a schematic diagram of the structure of the airway spray cryoablation system of the present invention;

FIG18 is a schematic diagram of the structure of a lifting system in an airway spray cryoablation system;

FIG19 is a schematic diagram of the structure of a lifting system in an airway spray cryoablation system;

FIG20 is a schematic diagram of the structure of the lifting system in the airway spray cryoablation system;

FIG21 is a schematic diagram of the structure of a lifting system in an airway spray cryoablation system;

FIG. 22 is a schematic diagram of the structure of the lifting system in the airway spray cryoablation system.

The reference numerals include:

1. Gas source; 2. Conduit; 21. Inlet pipe; 22. Insulation layer; 221. Vacuum outer tube; 222. Vacuum inner tube; 223. Insulation outer cavity; 224. Insulation inner cavity; 225. Spring tube; 226. Liner tube; 23. Cryoprobe; 231. Spray hole; 24. Inlet joint; 25. Vacuum joint; 26. Marking ring; 27. Cryoprobe extension tube; 270. Extension tube marking ring; 2701. First extension tube marking ring; 2702. Second extension tube marking ring; 28. Centering device; 280. Centering device marking ring; 2801. First centering device marking ring; 2802. Second centering device marking ring; 4. Cryogenic medium storage; 3. Heat exchange system; 31. Heat exchanger; 32. Connecting pipeline; 321. First connecting pipe Take the pipe; 322, the second connecting pipe; 33, the vacuum sleeve; 34, the retractable pipe; 5, the vacuum system; 51, the vacuum connecting pipe; 52, the vacuum pump; 6, the control system; 61, the industrial computer; 62, the pressure valve; 63, the input regulator; 64, the temperature monitor; 65, the vacuum monitor; 66, the thermocouple; 67, the refrigerant medium reserve monitor; 68, the liquid level monitoring device; 7, the filtering system; 71, the primary filter; 72, the secondary filter; 8, the lifting system; 81, the lifting power device; 82, the lifting assembly; 821, the lifting rod; 822, the lifting base; 823, the vacuum insulation sleeve; 824, the slider; 825, the top plate; 826, the bottom plate; 91, the lungs; 92, the endoscope; 93, the trachea; 94, the bronchi.

Detailed ways

The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

It should be noted that, in the absence of conflict, the embodiments of the present invention and the features in the embodiments may be combined with each other.

The present invention will be further described below in conjunction with the accompanying drawings and specific embodiments, but they are not intended to limit the present invention.

As shown in FIGS. 1-3 , the present application provides an airway tissue ablation device, including an air source 1 , a cryogenic medium storage 4 , a heat exchange system 3 , a catheter 2 , and a control system 6 .

The heat exchange system 3 includes a heat cooler 31 and a connecting pipeline 32. The heat cooler 31 is arranged in the refrigerant storage 4. The connecting pipeline 32 includes a first connecting pipeline 321 and a second connecting pipeline 322. The proximal end of the first connecting pipeline 321 is connected to the distal pipeline of the gas source 1, and the distal end of the first connecting pipeline 321 is connected to the proximal pipeline of the heat cooler 31. The proximal end of the second connecting pipeline 322 is connected to the distal pipeline of the heat cooler 31. Preferably, the heat cooler 31 includes but is not limited to a metal spring tube or a metal bellows.

The catheter 2 includes an air inlet pipe 21 and a cryoprobe 23. The proximal end of the air inlet pipe 21 is connected to the distal end of the second connecting pipeline 322. The proximal end of the cryoprobe 23 is connected to the distal end of the air inlet pipe 21.

The control system 6 includes an input regulator 63, a refrigerant storage monitor 67, and an industrial computer 61. The input regulator 63 is disposed on the first connecting pipeline 321. The refrigerant storage monitor 67 is disposed on the refrigerant storage 4. The industrial computer 61 is electrically connected to the input regulator 63 and the refrigerant storage monitor 67, respectively.

In the ablation device of the present invention, the cryogenic medium reserve monitor 67 monitors the cryogenic medium reserve in the cryogenic medium storage device 4, and the monitoring methods include but are not limited to weighing measurement and temperature measurement, and feedback is given to the industrial computer 61. The industrial computer 61 calculates the required input pressure according to the cryogenic medium reserve, and automatically fine-adjusts the input pressure according to the instruction, and sends the instruction to the input regulator 63. The input regulator 63 automatically fine-adjusts the input pressure according to the instruction. If the cryogenic medium reserve decreases, the input regulator 63 increases the input power accordingly to improve the heat exchange efficiency of the heat exchanger 31, otherwise the input pressure is automatically reduced. During the operation of the heat exchange system, this automatic adjustment process is a continuous dynamic balance process, and the pressure adjustment range is controlled within 10%.

In a preferred embodiment, as shown in FIG. 3 , the cryoprobe 23 further includes a spray hole 231 , which is opened on the distal wall of the cryoprobe 23 , and the cross-sectional area of the spray hole 231 is not less than the cross-sectional area of the air inlet pipe 21 .

In a preferred embodiment, the heat exchange system 3 further includes a vacuum sleeve 33, which is covered outside the second connecting pipeline 322. The vacuum sleeve 33 provides vacuum insulation performance, reduces the impact of the external environment on the non-refrigerated area, and improves the accuracy of cold delivery control. Preferably, a vacuum monitor 65 is provided on the vacuum sleeve 33 to monitor the vacuum insulation performance.

In a preferred embodiment, as shown in FIGS. 10-12 , the conduit 2 further includes a heat insulation layer 22 , and the heat insulation layer 22 is covered on the outside of the air inlet pipe 21 .

In a preferred embodiment, as shown in FIGS. 4-6 , the heat insulation layer 22 includes at least one vacuum inner tube 222 and a vacuum outer tube 221; the vacuum inner tube 222 is covered outside the air intake pipe 21, and the vacuum inner tube 222 and the air intake pipe 21 are surrounded by a heat insulation layer inner cavity 224. Preferably, a plurality of vacuum inner tubes 222 are coaxially sleeved. The vacuum outer tube 221 is sleeved outside the vacuum inner tube 222, and the vacuum outer tube 221 and the vacuum inner tube 222 are surrounded by a heat insulation layer outer cavity 223.

In a more preferred embodiment, the heat insulating layer 22 is made of a polymer flexible material, and the polymer flexible material includes but is not limited to: nylon and/or polyimide.

In a more preferred embodiment, as shown in FIG. 4 , the heat insulation layer 22 includes a plurality of vacuum tubes.

In a more preferred embodiment, as shown in FIG5 , the thermal insulation layer 22 comprises a single multi-cavity tube, and a plurality of spacers are used to connect the vacuum outer tube 221 and the vacuum inner tube 222 and divide the thermal insulation layer outer cavity 223 between the vacuum outer tube 221 and the vacuum inner tube 222 into a plurality of cavities.

In a more preferred embodiment, as shown in FIG. 6 , the vacuum outer tube 221 is a spring tube 225 , and the vacuum inner tube 222 is an inner liner tube 226 .

In a preferred embodiment, as shown in Figures 1 and 7, the catheter 2 also includes an air inlet connector 24 and a vacuum connector 25; the proximal end of the air inlet connector 24 is connected to the distal end of the second connecting pipeline 322, and the distal end of the air inlet connector 24 is connected to the proximal end of the air inlet pipe 21; the distal end of the vacuum connector 25 is connected to the proximal end of the insulation layer 22.

In a preferred embodiment, as shown in FIGS. 1 and 7 , the ablation device further includes a vacuum system 5 , and the vacuum system 5 is connected to the pipelines of the thermal insulation layer 22 and the vacuum sleeve 33 , respectively.

As shown in Fig. 7, the vacuum system 5 includes a vacuum pump 52 and a vacuum connecting pipe 51. The proximal end of the vacuum connecting pipe 51 is connected to the pipeline of the vacuum pump 52, the distal end of the vacuum connecting pipe 51 is connected to the proximal pipeline of the vacuum connector 25, and the vacuum connecting pipe 51 is provided with the vacuum monitor 65.

In a preferred embodiment, as shown in FIG8 , the catheter 2 further includes a cryoprobe extension tube 27 and an extension tube marker ring 270. The cryoprobe extension tube 27 is made of a flexible material having a certain deformation and shaping ability, the proximal end of the cryoprobe extension tube 27 is connected to the distal pipeline of the air inlet pipe 21, and the distal end of the cryoprobe extension tube 27 is connected to the proximal pipeline of the cryoprobe 23. Preferably, the extension tube marker ring 270 includes a first extension tube marker ring 2701 and a second extension tube marker ring 2702. The first extension tube marker ring 2701 is arranged on the proximal outer wall of the cryoprobe extension tube 27; the second extension tube marker ring 2702 is arranged on the distal outer wall of the cryoprobe extension tube 27.

In this preferred embodiment, the cryoprobe extension tube 27 can be bent by pre-contacting the bronchus 94 to form a suitable bending angle, and the cryoprobe 23 can be extended to a position where the endoscope 92 cannot enter due to the large angle of the bronchus 94 for freezing.

In a preferred embodiment, as shown in FIG9 , the catheter 2 further includes a centering device 28 and a centering device marker ring 280. The centering device 28 is made of a material having memory and elasticity, the proximal end of the centering device 28 is connected to the distal pipeline of the air inlet pipe 21, the distal end of the centering device 28 is connected to the proximal pipeline of the cryoprobe 23, the cryoprobe 23 is arranged at the axial center of the centering device 28, and the centering device 28 is arranged within the thermal insulation layer 22. Preferably, the centering device marker ring 280 includes a first centering device marker ring 2801 and a second centering device marker ring 2802; the first centering marker ring 2801 is arranged on the proximal outer wall of the centering device 28; the second centering marker ring 2802 is arranged on the distal outer wall of the centering device 28.

In this preferred embodiment, the centering device 28 can be pre-set to have a diameter slightly larger than the maximum diameter of the bronchus 94. After the centering device 28 is extended out of the endoscope, it is expanded into a predetermined shape so that the cryoprobe 23 is always located in the center position.

In a preferred embodiment, the control system 6 further includes a pressure valve 62, a temperature monitor 64, a vacuum monitor 65, and at least one thermocouple 66. The pressure valve 62 is disposed on the first connecting pipeline 321 near the far end of the gas source 1; the temperature monitor 64 is disposed on the second connecting pipeline 322; the vacuum monitor 65 is disposed on the insulation layer 22 and the vacuum sleeve 33; the thermocouple 66 is disposed on the conduit 2. The industrial computer 61 is electrically connected to the pressure valve 62, the temperature monitor 64, the vacuum monitor 65, and the thermocouple 66, respectively.

In the preferred embodiment, the temperature monitor 64 monitors the temperature of the freezing medium output from the heat cooler 31 and feeds back to the industrial computer 61. The industrial computer 61 automatically determines whether the temperature parameters provided by the temperature monitor 64, the conduit 2 and the thermocouple 66 meet the requirements. The temperature parameter can be, but is not limited to, a temperature value or a temperature change slope. In the preferred embodiment, the thermocouple 66 transmits the temperature information of the freezing probe 23 to the industrial computer 61. When the temperature information of the freezing probe 23 meets the working requirements, the industrial computer 61 will start timing, and when the preset or ideal freezing time is reached, the freezing output will be turned off.

In a preferred embodiment, the thermocouple 66 is disposed in the cryoprobe 23 .

In a preferred embodiment, as shown in Figs. 10-12, a plurality of the thermocouples 66 are arranged on at least one of the inner wall of the thermal insulation layer 22, the inner wall of the thermal insulation layer 22, or the outer wall of the thermal insulation layer 22. In this preferred embodiment, a plurality of thermocouples 66 are connected in parallel. When the system is running, the control system 6 can simultaneously monitor the working temperature of the cryoprobe 23 and the temperature of the thermal insulation layer 22, and compare them with the pre-set temperature or temperature slope to determine the working state and thermal insulation performance of the catheter 2; when it is determined that the thermal insulation performance has a downward trend, the control system 6 will issue instructions to the vacuum pump 52 to increase the working output; when it is determined that the thermal insulation performance does not meet the requirements, an alarm will be issued.

In a preferred embodiment, a plurality of the thermocouples 66 are disposed on the outer wall of the centering device 28. In this preferred embodiment, the thermocouples 66 can monitor the tissue temperature and the ambient temperature within and near the freezing range during the freezing process, and feed back to the control system 6.

In a preferred embodiment, the ablation device also includes a filtering system 7, which includes a primary filter 71 and a secondary filter 72: the primary filter 71 is arranged on the first connecting pipe 321 near the distal end of the pressure valve 62; the secondary filter 72 is arranged on the first connecting pipe 321 near the proximal end of the thermal cooler 31.

In this preferred embodiment, the gas source 1 provides a refrigerant medium in a gas phase, and preliminarily adjusts the input pressure through a pressure valve 62, passes through a primary filter 71, an input regulator 63, the input regulator precisely adjusts the input pressure, and a secondary filter 72 to enter the heat exchange system 3, and the refrigerant medium undergoes a gas-liquid conversion in the heat refrigerator 31, from a normal temperature gas to a low temperature liquid; the cooled refrigerant medium passes through a temperature monitor 64 and then enters the air inlet pipe 21, and the refrigerant medium is output from the freezing probe 23.

As shown in FIG13 , the present invention also provides a control method for an ablation device, which is used to control the ablation device for airway tissue. The control method includes: starting the device, performing a system self-check, and if there is an abnormality, performing a system debugging. After debugging, perform self-test again; if normal, enter the freezing mode; set the points that need to be frozen, determine the cold capacity of the corresponding freezing points, and adjust the input pressure according to the initial storage of the freezing medium; use the compensation mechanism to adjust the input pressure in real time according to the change of the freezing medium storage, and compensate for the cold capacity by increasing the input pressure; monitor the storage of the freezing medium, the output temperature of the refrigerant, the output temperature of the conduit, the vacuum degree of the system and the required freezing time; the monitored information is fed back to the compensation mechanism and the judgment mechanism in real time; if an abnormality occurs during the process, the freezing is suspended and the system self-test is performed again; the judgment mechanism is used to judge the input cold capacity. If it is judged that the real-time input cold capacity does not meet the set range, it is fed back to the compensation mechanism. The compensation mechanism adjusts the input cold capacity in combination with the information of the monitoring system and the judgment system; if the real-time cold capacity exceeds the safety range, pressure relief is performed.

Specifically, the control method of the ablation device includes the following steps:

After starting up, the system will conduct self-test, which includes: whether the catheter 2 is connected, whether the storage of the freezing medium meets the requirements, whether the control system 6 is working properly, the status of the sensor and whether the performance of the catheter is normal, etc. After the self-test is completed, the system will automatically prompt the self-test result. If it is abnormal and needs to be debugged, it will be self-tested again after debugging; if it is normal, it will enter the freezing mode;

After entering the freezing mode, set the point to be frozen, the system automatically determines and confirms the cold capacity of the corresponding freezing point, and adjusts the input pressure according to the initial storage of the freezing medium; after the freezing starts, the cold capacity compensation mechanism and the control system 6 will start working at the same time;

During the freezing process, the freezing medium will be continuously consumed, the freezing reserve will decrease, and the output cooling capacity will decrease. The cooling capacity compensation mechanism will adjust the input pressure according to the cooling capacity reserve and compensate the cooling capacity by increasing the input pressure.

The control system 6 will monitor the storage of the freezing medium, the output temperature of the refrigerant, the output temperature of the conduit, the vacuum degree of the system and the required freezing time during the freezing process; the monitored information will be fed back to the compensation mechanism and the judgment mechanism in real time; if an abnormality occurs during the process, it will automatically judge and suspend the freezing, and re-perform the system self-check process;

The judgment mechanism will judge the input cooling capacity. If it is judged that the real-time input cooling capacity does not meet the set range, it will be fed back to the compensation mechanism. The compensation mechanism will adjust the input cooling capacity based on the information of the monitoring system and the judgment system. If the real-time cooling capacity exceeds the safe range, pressure relief will be performed.

As shown in Figures 14-16, the cryotherapy process is to pass the catheter 2 through the instrument channel of the endoscope 92, the endoscope 92 passes through the trachea 93 to reach the lungs 91, and the cryoprobe 23 is exposed in the bronchus 94. The cryoprobe 23 sprays the freezing medium evenly on the surface of the bronchus to perform cryotherapy, kill the diseased epithelial cells, and retain the extracellular matrix. A healthy epithelial layer can be quickly grown on the basis of the extracellular matrix. After a single cryotherapy is completed, if multiple treatments are needed, the cryoprobe 23 is moved backward to freeze the unfrozen area, and the above freezing process is repeated until the target tissue has completed the cryotherapy.

The ablation device of the present invention consumes the cryogenic medium reserve as it runs, and the output of cold energy will also change accordingly. Through monitoring and judgment by the control system, the pressure input to the heat refrigerator is automatically and accurately adjusted according to the cold energy reserve for compensation, thereby accurately controlling the output of cold energy; an insulation layer is provided outside the air inlet pipe, and real-time vacuum monitoring is provided, so that the cold energy is not disturbed by the external environment during transportation, thereby improving the accuracy of cold energy transportation. The cryoprobe has an adaptive centering function to ensure that the cryoprobe is located in the center of the airway when liquid nitrogen is sprayed, thereby improving the uniformity of freezing. The flexible material further improves the application performance of the catheter in the endoscope.

As shown in FIG17 , the present invention further provides a spray cryoablation system, comprising the above-mentioned airway tissue ablation device. The spray cryoablation system further comprises a lifting system 8. The lifting system 8 comprises a lifting power device 81 and a lifting assembly 82; the lifting power device 81 is connected to the industrial computer 61; the lifting assembly 82 is respectively connected to the lifting power device 81 and the thermal cooler 31, and is used to control the contact area between the thermal cooler 31 and the freezing medium in the freezing medium storage 4.

In a preferred embodiment, the control system of the spray cryoablation system further includes a temperature monitor 64; the temperature monitor 64 is arranged on the second connecting pipeline 322 and connected to the industrial computer 61. The temperature monitor 64 monitors the temperature of the freezing medium output from the thermal refrigerator 31 and feeds back to the industrial computer 61. The industrial computer 61 automatically determines whether the temperature parameter provided by the temperature monitor 64 meets the requirements. The temperature parameter can be, but is not limited to, a temperature value or a temperature change slope; according to the judgment result, the industrial computer 61 sends a command to the lifting system 8; after receiving the command, the lifting system 8 provides power through the lifting power device 81 to adjust the contact area between the thermal refrigerator 31 and the freezing medium to achieve the output cooling capacity adjustment; the temperature monitor 64 will continue to monitor and feedback to complete real-time adjustment to ensure that the output cooling capacity is constant.

In a preferred embodiment, the control system further includes a liquid level monitoring device 68. The liquid level monitoring device 68 is arranged on the refrigerant storage 4 and connected to the industrial computer 61. The liquid level monitoring device 68 monitors the refrigerant storage in the refrigerant storage 4 in real time and feeds back to the industrial computer 61. The industrial computer 61 automatically determines whether the refrigerant storage meets the requirements. According to the determination result, the industrial computer 61 sends a command to the lifting system 8; the industrial computer 61 combines the temperature parameter and the refrigerant storage parameter and sends the lifting system adjustment command.

The above two embodiments, namely the temperature control by the temperature monitor 64 and the liquid level control by the liquid level monitoring device 68, can be operated separately or synchronously.

In a preferred embodiment, the lifting power device includes but is not limited to hydraulic transmission, thread rotation transmission or roller transmission.

In a preferred embodiment, the heat exchange system 3 further includes: a telescopic pipeline 34 to accommodate the adjustment of the heat cooler 31 relative to the refrigerating medium. The telescopic pipeline 34 includes a first telescopic pipeline and a second telescopic pipeline; the distal end of the first telescopic pipeline is connected to the proximal pipeline of the heat cooler 31; the proximal end of the second telescopic pipeline is connected to the distal pipeline of the heat cooler 31.

In a preferred embodiment, the telescopic pipeline 34 includes but is not limited to a metal bellows or an elastic polymer tube.

In a preferred embodiment, as shown in FIG. 17 , the lifting assembly 82 includes a lifting rod 821 and a lifting base 822 : the lifting rod 821 is connected to the lifting power device 81 ; The base 822 is disposed at the bottom of the thermal cooler 31 , and the top of the lifting base 822 is fixedly connected to the bottom of the lifting rod 821 .

In a preferred embodiment, as shown in FIGS. 18-19 , the lifting assembly 82 includes a lifting rod 821 , the top of the lifting rod 821 is connected to the lifting power device 81 , and the bottom of the lifting rod 821 is fixedly connected to the top of the thermal cooler 31 .

In a preferred embodiment, as shown in Figure 20, the lifting assembly 82 includes a lifting rod 821 and a vacuum insulation sleeve 823; the lifting rod 821 is connected to the lifting power device 81; the vacuum insulation sleeve 823 is mounted outside the heat cooler 31, and the top of the vacuum insulation sleeve 823 is fixedly connected to the bottom of the lifting rod 821.

In a preferred embodiment, as shown in Figure 21, the lifting assembly 82 includes a lifting rod 821 and a slider 824; the lifting rod 821 is connected to the lifting power device 81; the slider 824 is arranged in the refrigerant medium storage 4, and the top of the slider 824 is fixedly connected to the bottom of the lifting rod 821. By moving the slider 824, the liquid level of the refrigerant medium relative to the thermal refrigerator is changed to control the contact area between the thermal refrigerator and the refrigerant medium.

In a preferred embodiment, as shown in Figure 22, the lifting assembly 82 includes a top plate 825 and a bottom plate 826; the top plate 825 is arranged at the bottom of the refrigerant medium storage container 4, and the top plate 825 is arranged at the top of the lifting power device 81; the bottom plate 826 is arranged at the bottom of the lifting power device 81, and the bottom plate 826 and the top plate 825 are movably connected. Through the contraction or expansion of the lifting power device 81, the liquid level height of the refrigerant medium relative to the thermal refrigerator is changed to control the contact area between the thermal refrigerator and the refrigerant medium.

The spray cryoablation system of the present invention consumes the freezing medium during operation, that is, the liquid level drops, resulting in a reduction in the contact area. Through monitoring and judgment by the control system, the lifting component is adjusted in real time to keep the contact area constant, thereby accurately controlling the output of cold. An insulating layer is provided outside the air inlet pipe, and real-time vacuum monitoring is provided to prevent the cold from being disturbed by the external environment during transportation, thereby improving the accuracy of cold transportation and protecting the non-freezing area from causing damage to medical staff, patients or supporting equipment. The freezing probe has an adaptive centering function to ensure that the freezing probe is located in the center of the airway when liquid nitrogen is sprayed, thereby improving the uniformity of freezing, and the flexible material further improves the application performance of the catheter in the endoscope.

The above description is only a preferred embodiment of the present invention, and does not limit the implementation mode and protection scope of the present invention. For those skilled in the art, it should be aware that all solutions obtained by equivalent substitutions and obvious changes made using the description and illustrations of the present invention should be included in the protection scope of the present invention.

Claims (32)

An airway tissue ablation device, characterized by comprising: Gas source (1); A freezing medium storage container (4); A heat exchange system (3), the heat exchange system (3) comprising: a thermal cooler (31), the thermal cooler (31) being arranged in the refrigerating medium storage (4), and A connecting pipeline (32), wherein the connecting pipeline (32) comprises: a first connecting pipeline (321), the proximal end of the first connecting pipeline (321) being connected to the distal pipeline of the gas source (1), the distal end of the first connecting pipeline (321) being connected to the proximal pipeline of the thermal cooler (31), and A second connecting pipeline (322), the proximal end of the second connecting pipeline (322) being connected to the distal pipeline of the thermal cooler (31); A catheter (2), the catheter (2) comprising: an air intake pipe (21), the proximal end of the air intake pipe (21) being connected to the distal end of the second connecting pipe (322), and A cryoprobe (23), the proximal end of the cryoprobe (23) being connected to the distal end of the air inlet pipe (21); and A control system (6), the control system (6) comprising: an input regulator (63), wherein the input regulator (63) is arranged on the first connecting pipeline, a refrigerating medium reserve monitor (67), the refrigerating medium reserve monitor (67) being arranged on the refrigerating medium storage (4), and An industrial computer (61), the industrial computer (61) being electrically connected to the input regulator (63) and the refrigeration medium storage monitor (67) respectively. The ablation device according to claim 1, characterized in that the heat exchange system (3) further comprises a vacuum sleeve (33), and the vacuum sleeve (33) is covered outside the second connecting pipeline (322). The ablation device according to claim 2, characterized in that the catheter (2) further comprises a heat insulation layer (22), the heat insulation layer (22) is covered outside the air inlet pipe (21), and the heat insulation layer (22) comprises: At least one layer of vacuum inner tube (222), the vacuum inner tube (222) being covered outside the air intake pipe (21), the vacuum inner tube (222) and the air intake pipe (21) enclosing a heat insulation layer inner cavity (224), and a plurality of the vacuum inner tubes (222) being coaxially sleeved; and The vacuum outer tube (221) is sleeved outside the vacuum inner tube (222), and the vacuum outer tube (221) and the vacuum inner tube (222) are surrounded by a heat insulation layer outer cavity (223). The ablation device according to claim 3 is characterized in that the thermal insulation layer (22) comprises a single multi-lumen tube, the vacuum outer tube (221) is connected to the vacuum inner tube (222) by a plurality of spacers, and the outer cavity (223) of the thermal insulation layer between the vacuum outer tube (221) and the vacuum inner tube (222) is divided into a plurality of cavities. The ablation device according to claim 3 is characterized in that the vacuum outer tube (221) is a spring tube (225), and the vacuum inner tube (222) is an inner lining tube (226). The ablation device according to claim 1, characterized in that the cryoprobe (23) comprises a spray hole (231), the spray hole (231) is opened on the distal end wall of the cryoprobe (23), and the spray hole The cross-sectional area of (231) is not less than the cross-sectional area of the air intake pipe (21). The ablation device according to claim 3 is characterized in that it also includes a vacuum system (5), and the vacuum system (5) is respectively connected to the insulation layer (22) and the vacuum sleeve (33) pipeline. The ablation device according to claim 7, characterized in that the catheter (2) further comprises: An air intake connector (24), the proximal end of the air intake connector (24) being connected to the distal end of the second connecting pipeline (322), and the distal end of the air intake connector (24) being connected to the proximal end of the air intake pipe (21); and A vacuum joint (25), the distal end of the vacuum joint (25) being connected to the proximal pipeline of the thermal insulation layer (22). The ablation device according to claim 8, characterized in that the vacuum system (5) comprises: a vacuum pump (52); and A vacuum connecting tube (51), wherein the proximal end of the vacuum connecting tube (51) is connected to the pipeline of the vacuum pump (52), the distal end of the vacuum connecting tube (51) is connected to the proximal pipeline of the vacuum joint (25), and the vacuum monitor (65) is arranged on the vacuum connecting tube (51). The ablation device according to claim 1, characterized in that the catheter (2) further comprises: a cryoprobe extension tube (27), wherein the cryoprobe extension tube (27) is made of a flexible material having a certain deformation and shaping capability, the proximal end of the cryoprobe extension tube (27) is connected to the distal end pipeline of the air inlet pipe (21), and the distal end of the cryoprobe extension tube (27) is connected to the proximal end pipeline of the cryoprobe (23); and An extension tube marker ring (26), the extension tube marker ring (26) comprising: a first extension tube marker ring (261), the first extension tube marker ring (261) being arranged on the outer wall of the proximal end of the cryoprobe extension tube (27); and A second extension tube marking ring (262), wherein the second extension tube marking ring (262) is arranged on the outer wall of the distal end of the cryoprobe extension tube (27). The ablation device according to claim 3, characterized in that the catheter (2) further comprises: A centering device (28), wherein the proximal end of the centering device (28) is connected to the distal pipeline of the air inlet pipe (21), the distal end of the centering device (28) is connected to the proximal pipeline of the cryoprobe (23), the cryoprobe (23) is arranged at the axial center of the centering device (28), and the centering device (28) is arranged within the thermal insulation layer (22). The ablation device according to claim 11, characterized in that the centering device (28) is made of a material having memory and elastic capabilities. The ablation device according to claim 11, characterized in that the catheter (2) further comprises: a centering device marker ring (29), wherein the centering device marker ring (29) comprises: A first centering device marking ring (291), wherein the first centering device marking ring (291) is arranged on the proximal outer wall of the centering device (28); A second centering device marking ring (292), wherein the second centering device marking ring (292) is arranged on the distal outer wall of the centering device (28). The ablation device according to claim 1, characterized in that the control system (6) further comprises: A pressure valve (62), wherein the pressure valve (62) is arranged on the first connecting pipeline (321) close to the far end of the gas source (1) and is electrically connected to the industrial computer (61). The ablation device according to claim 3, characterized in that the control system (6) further comprises: A vacuum monitor (65), wherein the vacuum monitor (65) is disposed on the heat insulation layer (22) and the vacuum sleeve (33), and is electrically connected to the industrial computer (61). The ablation device according to claim 11 is characterized in that the control system (6) further comprises: at least one thermocouple (66), wherein the thermocouple (66) is arranged on the catheter (2) and is electrically connected to the industrial computer (61). The ablation device according to claim 16, characterized in that the thermocouple (66) is arranged in the cryoprobe (23). The ablation device according to claim 16 is characterized in that the plurality of thermocouples (66) are arranged at least one of the inner wall of the thermal insulation layer (22), the inner wall of the thermal insulation layer (22), or the outer wall of the thermal insulation layer (22). The ablation device according to claim 16 is characterized in that a plurality of the thermocouples (66) are arranged on the outer wall of the centering device (28). The ablation device according to claim 14, further comprising a filtering system (7), wherein the filtering system (7) comprises: a primary filter (71), the primary filter (71) being disposed on the first connecting pipeline (321) near the distal end of the pressure valve (62); and A secondary filter (72), wherein the secondary filter (72) is arranged on the first connecting pipeline (321) near the proximal end of the thermal cooler (31). The ablation device according to claim 1 is characterized in that the control system (6) further includes a temperature monitor (64) arranged on the second connecting pipeline (322). An airway spray cryoablation system, characterized by comprising: An ablation device for airway tissue according to any one of claims 1-20; and A lifting system (8), the lifting system (8) comprising: A lifting power device (81) is connected to the industrial computer (61), and A lifting assembly (82) is connected to the lifting power device (81) and the thermal cooler (31) respectively, and is used to control the contact area between the thermal cooler (31) and the freezing medium in the freezing medium storage container (4). The airway spray cryoablation system according to claim 22, characterized in that the control system further comprises: A temperature monitor (64) is arranged on the second connecting pipeline and is connected to the industrial computer (61). The airway spray cryoablation system according to claim 22, characterized in that the control system further comprises: A liquid level monitoring device (68) is arranged on the freezing medium storage device (4) and is connected to the industrial computer (61). The airway spray cryoablation system according to any one of claims 22 to 24, characterized in that the lifting assembly (82) comprises: A lifting rod (821), the lifting rod (821) being connected to the lifting power device (81); and A lifting base (822), wherein the lifting base (822) is arranged at the bottom of the thermal cooler (31), and the top of the lifting base (822) is fixedly connected to the bottom of the lifting rod (821). The airway spray cryoablation system according to any one of claims 22 to 24, characterized in that the lifting assembly (82) comprises: A lifting rod (821), the top of which is connected to the lifting power device (81), and the bottom of which is fixedly connected to the top of the thermal cooler (31). The airway spray cryoablation system according to any one of claims 22 to 24, characterized in that the lifting assembly (82) comprises: A lifting rod (821), the lifting rod (821) being connected to the lifting power device (81); and A vacuum insulation sleeve (823), wherein the vacuum insulation sleeve (823) is sleeved outside the heat cooler (31), and the top of the vacuum insulation sleeve (823) is fixedly connected to the bottom of the lifting rod (821). The airway spray cryoablation system according to any one of claims 22 to 24, characterized in that the lifting assembly (82) comprises: A lifting rod (821), wherein the lifting rod (821) is connected to the lifting power device (81); and A slider (824), wherein the slider (824) is disposed inside the freezing medium storage container (4), and the top of the slider (824) is fixedly connected to the bottom of the lifting rod (821). The airway spray cryoablation system according to any one of claims 22 to 24, characterized in that the lifting assembly (82) comprises: A top plate (825), the top plate (825) being disposed at the bottom of the freezing medium storage container (4), the top plate (825) being disposed at the top of the lifting power device (81); and A bottom plate (826) is arranged at the bottom of the lifting power device (81), and the bottom plate (826) is movably connected to the top plate (825). The liquid level height of the freezing medium relative to the heat refrigerator is changed by the contraction or expansion of the lifting power device (81). The airway spray cryoablation system according to any one of claims 22 to 29, characterized in that the heat exchange system (3) further comprises: a telescopic pipeline (34) to accommodate the adjustment of the thermal cooler (31) relative to the cryogenic medium, the telescopic pipeline 34 comprising: A first telescopic pipeline, the distal end of which is connected to the proximal pipeline of the thermal cooler 31; and The proximal end of the second telescopic pipeline is connected to the distal pipeline of the thermal cooler 31 . The airway spray cryoablation system according to any one of claims 22-30 is characterized in that the lifting component controls the contact area between the thermal cooler (31) and the freezing medium by changing the liquid level height of the freezing medium relative to the thermal cooler (31). A control method for an ablation device, used for controlling the ablation device according to any one of claims 1 to 21, the control method comprising: After powering on, the system will self-check. If abnormal, the system will be debugged. After debugging, self-check will be performed again. If normal, the system will enter the freezing mode. Set the points that need to be frozen, determine the cooling capacity of the corresponding freezing points, and adjust the input pressure according to the initial storage of the freezing medium; A compensation mechanism is used to adjust the input pressure in real time according to the change of the refrigeration medium storage capacity, and the cooling capacity is compensated by increasing the input pressure; Monitor the storage of the freezing medium, the output temperature of the refrigerant, the output temperature of the conduit, the vacuum degree of the system and the required freezing time; the monitored information is fed back to the compensation mechanism and the judgment mechanism in real time; if an abnormality occurs during the process, the freezing is suspended and the system self-check is performed again; A judgment mechanism is used to judge the input cooling capacity. If the real-time cooling capacity input does not meet the set range, it will be fed back to the compensation mechanism. The compensation mechanism adjusts the input cooling capacity based on the information of the monitoring system and the judgment system. If the real-time cooling capacity exceeds the safety range, pressure relief is performed.