Vascular ablation system

Abstract

The invention relates to the technical field of medical instruments, and discloses a blood vessel ablation system. The system comprises an ablation catheter, a heating element, a pressure sensor and a radio frequency generator, pressure borne by the catheter in a blood vessel is detected in real time through the pressure sensor, pressure data are fed back to the radio frequency generator, the radio frequency generator judges the contact condition of the catheter and the blood vessel wall according to the pressure data, and then a corresponding indication signal is sent out. And injection of swelling liquid and output of radio frequency energy are controlled. The system can monitor the contact condition of the catheter and the blood vessel wall in real time, eliminate dependence on experience of doctors, achieve accurate control and improve safety and effectiveness of blood vessel ablation treatment.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to radiofrequency ablation technology for treating vascular diseases. Background Art

[0002] Varicose veins are one of the most common vascular diseases in clinical practice. As the disease progresses, the patient's veins will expand abnormally, resulting in poor blood return, which can cause a series of symptoms. Radiofrequency ablation technology is a common method for treating varicose veins. It uses the radiofrequency energy generated by the heating element in the catheter to close the damaged blood vessels, thereby achieving a therapeutic effect. This technology has achieved good results in the treatment of varicose veins and is widely used in clinical practice. However, the existing radiofrequency ablation technology still has some technical bottlenecks, which limit its wide application and further improvement of the treatment effect.

[0003] The existing radiofrequency ablation treatment process usually requires the use of a catheter-type thermal ablation device. During the treatment, the doctor needs to inject tumescent anesthetic fluid or saline into the blood vessel area to be ablated. The purpose of injecting tumescent fluid is to make the blood vessel wall fully contact with the catheter heating element through external pressure to ensure that the heat can be effectively transferred to the blood vessel wall, thereby achieving the ablation effect. However, in the prior art, the dosage and pressure of the injected tumescent fluid are completely dependent on the doctor's experience. Due to differences in different blood vessel types, patient constitutions and treatment sites, the doctor's experience and judgment can hardly guarantee consistent results for each treatment. This experience-based approach has the following problems:

[0004] In the existing technology, doctors cannot monitor the contact between the blood vessels and the catheter heating element in real time, and can only rely on experience to determine whether to continue or stop injecting the tumescent fluid. Due to the lack of real-time feedback information, different doctors may inject too much or too little tumescent fluid when facing different patients, resulting in insufficient or excessive contact between the blood vessels and the catheter, affecting the treatment effect.

[0005] Since the injection volume and pressure of the tumescent fluid cannot be precisely controlled, in some cases, the contact pressure between the catheter and the blood vessel wall is too high, which may cause adhesion between the catheter and the tissue, or even cause tissue damage; and when the pressure is insufficient, the heat cannot be fully transferred to the blood vessel wall, which can easily lead to underheating and incomplete treatment. This uncertainty leads to differences in treatment effects, especially in different patients and different treatment areas, where the treatment results may vary significantly.

[0006] In the existing radiofrequency ablation technology, due to the lack of real-time pressure monitoring means, doctors cannot effectively monitor the pressure changes during the ablation process when applying radiofrequency energy. Therefore, when the contact between the catheter and the blood vessel wall is insufficient, it may lead to treatment failure; when the contact is too tight, it may cause adhesion between the catheter and the tissue, and even cause complications such as burns, increasing the risk of treatment.

[0007] In response to the above technical problems, there is an urgent need for a vascular ablation system that can monitor the contact between the catheter and the blood vessel wall in real time and can accurately control the injection volume and pressure of the tumescent fluid to improve the safety and consistency of treatment. Summary of the invention

[0008] The purpose of the present application is to provide a vascular ablation system to solve the problems raised in the above background technology.

[0009] The present application discloses a vascular ablation system, comprising:

[0010] An ablation catheter, comprising:

[0011] a heating element for ablative treatment of blood vessels;

[0012] A pressure sensor, disposed at the heating element, for detecting the pressure exerted on the ablation catheter in the blood vessel;

[0013] A radio frequency generator is electrically connected to the ablation catheter, and the radio frequency generator is used to:

[0014] receiving pressure data transmitted by the pressure sensor;

[0015] determining the contact condition between the heating element and the blood vessel wall according to the pressure data;

[0016] Based on the judgment result, determining whether ablation treatment conditions are met;

[0017] According to the comparison result between the pressure data and the preset pressure threshold, a corresponding indication signal is generated, wherein:

[0018] When the pressure data is lower than the preset pressure threshold, generating an indication signal for continuing to inject the tumescent fluid;

[0019] When the pressure data reaches or exceeds the preset pressure threshold, an indication signal is generated to stop injecting the tumescent fluid and start ablation therapy;

[0020] When it is determined that the ablation treatment conditions are met, radio frequency energy is provided to the heating element to perform ablation treatment.

[0021] In a preferred embodiment, the pressure sensor is selected from at least one of the following:

[0022] Varistor;

[0023] Strain gauges;

[0024] Piezoelectric elements;

[0025] Capacitive pressure sensor;

[0026] Fiber optic pressure sensor;

[0027] Conductive silicone ring;

[0028] Piezoelectric film.

[0029] In a preferred embodiment, the pressure sensor is a conductive silicone ring, and the preparation method thereof includes:

[0030] A ring-shaped metal electrode is deposited on the surface of the PI tube at the winding gap or the head and tail of the ablation catheter by using a metal deposition technology;

[0031] Filling the gap with an FEP outer sleeve and liquid conductive silicone and solidifying the resulting gap into a conductive silicone ring;

[0032] Remove the FEP outer sleeve;

[0033] The windings are covered with insulating sleeves.

[0034] In a preferred example, the conductive silicone ring is connected to an identification resistor in the ablation catheter handle via a dial switch, and is used to determine the pressure by identifying impedance changes during treatment.

[0035] In a preferred example, the pressure sensor is a piezoelectric film attached to the surface of the ablation catheter by deposition.

[0036] In a preferred embodiment, the device further comprises a display unit, which is electrically connected to the radio frequency generator and is used for:

[0037] displaying the indication signal;

[0038] Displaying the pressure data in real time;

[0039] showing the contact between the heating element and the blood vessel wall;

[0040] Displays the progress and parameters of ablation therapy.

[0041] In a preferred embodiment, the radio frequency generator is also used for:

[0042] After the pressure data reaches or exceeds the preset pressure threshold, continuously monitoring the pressure data;

[0043] When the pressure data drops below the preset pressure threshold, the following operations are performed:

[0044] a) generate a warning signal;

[0045] b) Pause or adjust the RF energy output;

[0046] c) re-generating an indication signal for continuing to inject the swelling fluid;

[0047] Setting an adjustable pressure threshold range, including an upper threshold and a lower threshold;

[0048] When the pressure data exceeds the upper threshold, an indication signal for reducing the injection of tumescent fluid is generated.

[0049] In a preferred example, the radio frequency generator further includes a storage unit, and the storage unit is used to store a plurality of preset pressure thresholds, each preset pressure threshold corresponding to a different blood vessel type or treatment site.

[0050] In a preferred embodiment, it further includes an input unit, which is electrically connected to the radio frequency generator and is used to:

[0051] Receive user input, including:

[0052] a) Vascular type;

[0053] b) Treatment area;

[0054] c) Patient characteristics, such as age, gender, weight, etc.;

[0055] Provides preset vessel type and treatment site options for users to choose from;

[0056] Allows the user to manually enter or adjust pressure thresholds and RF parameters;

[0057] Wherein, the radio frequency generator is based on the information received by the input unit:

[0058] Selecting a corresponding preset pressure threshold and radio frequency parameter from a storage unit;

[0059] Automatically adjust the selected preset pressure threshold and radiofrequency parameters according to patient characteristics;

[0060] During treatment, pressure thresholds and RF parameters are adjusted based on real-time input from the user.

[0061] In a preferred embodiment, the radio frequency generator is also used for:

[0062] Record data during ablation therapy, including:

[0063] a) Real-time changes in pressure data;

[0064] b) RF energy output parameters;

[0065] c) duration of treatment;

[0066] d) Temperature changes (if the system includes a temperature sensor);

[0067] Analyze recorded data, including:

[0068] a) Calculate the statistical characteristics of pressure data, such as average value, maximum value, minimum value and fluctuation range;

[0069] b) Identify abnormal change points in pressure data;

[0070] c) evaluate the correlation between RF energy output and pressure changes;

[0071] Generates comprehensive treatment reports including:

[0072] a) Data visualization, such as pressure-time graph;

[0073] b) summary of treatment parameters;

[0074] c) Records of abnormal events and handling measures;

[0075] d) Preliminary evaluation of treatment efficacy;

[0076] Provide report export and sharing functions, supporting multiple formats such as PDF, CSV, etc.;

[0077] Store treatment data and reports in a secure database to support subsequent query and analysis.

[0078] In a preferred example, the ablation catheter further includes a temperature sensor for detecting the temperature during the ablation treatment; the radio frequency generator adjusts the radio frequency energy provided to the heating element according to the detected temperature.

[0079] Compared with the prior art, the embodiments of the present application have at least the following differences and effects:

[0080] The present application provides a vascular ablation system, which can effectively solve the uncertainty problem caused by the injection of tumescent fluid relying on the doctor's experience in the prior art by integrating a pressure sensor and a radio frequency generator in the ablation catheter, and has the following significant technical effects:

[0081] The pressure sensor can detect the pressure of the catheter in the blood vessel in real time and feed the pressure data back to the RF generator. The RF generator determines the contact between the catheter heating element and the blood vessel wall based on the pressure data. This technical means can help doctors accurately grasp the degree of fit between the catheter and the blood vessel wall, ensure that the catheter is in close contact with the blood vessel wall during treatment, avoid overheating or underheating, and thus improve the treatment effect.

[0082] Through the feedback of the pressure sensor, the RF generator can send an indication signal according to the preset pressure threshold, prompting the doctor to continue or stop injecting the tumescent fluid. This design avoids the excessive reliance of traditional methods on the doctor's experience, reduces the problem of inconsistent treatment effects caused by differences in experience and judgment of different doctors, and realizes precise control of the vascular ablation process.

[0083] Real-time monitoring and feedback of pressure data enables the system to issue warning signals in time when the pressure is insufficient or excessive, and adjust the RF energy output. When the pressure is insufficient, the system will prompt to continue injecting the tumescent fluid; when the pressure is too high, the system will issue an instruction signal to stop injecting the tumescent fluid. This functional design can effectively avoid incomplete underheating treatment due to too low contact pressure between the catheter and the blood vessel wall, or tissue damage or catheter adhesion caused by excessive pressure, significantly improving the safety and effectiveness of ablation treatment.

[0084] Through the cooperation of the input unit and the storage unit, the present application allows doctors to make personalized pressure threshold and radio frequency parameter adjustments based on the patient's vascular type, treatment site and personal characteristics (such as age, gender, weight, etc.), so that the system can provide customized treatment plans based on different patient conditions, further improving the targetedness and accuracy of the treatment.

[0085] The system has data recording and analysis functions, which can record key parameters such as changes in pressure data, radiofrequency energy output, and treatment time during treatment, and generate detailed treatment reports. This function enables doctors to conduct a comprehensive evaluation of the treatment process, helps optimize and improve subsequent treatment plans, and also provides data support for patients' treatment effects.

[0086] By adding a temperature sensor, the system can monitor temperature changes during ablation in real time and automatically adjust the output of RF energy based on temperature feedback. This design ensures that when the contact between the catheter and the blood vessel wall is uneven, the heating element can still avoid local overheating or underheating through temperature control, further improving the accuracy and safety of treatment.

[0087] In summary, this application successfully overcomes many defects of the prior art by introducing technical means such as pressure monitoring, personalized parameter adjustment, data recording and analysis, and significantly improves the accuracy, safety and therapeutic effect of vascular ablation treatment.

[0088] A large number of technical features are recorded in the specification of this application, which are distributed in various technical solutions. If all possible combinations of technical features of this application (i.e., technical solutions) are to be listed, the specification will be too long. In order to avoid this problem, the various technical features disclosed in the above invention content, the various technical features disclosed in the various embodiments and examples below, and the various technical features disclosed in the accompanying drawings can be freely combined with each other to form various new technical solutions (these technical solutions are all deemed to have been recorded in this specification), unless such a combination of technical features is technically infeasible. For example, in one example, feature A+B+C is disclosed, and in another example, feature A+B+D+E is disclosed, and features C and D are equivalent technical means that play the same role. Technically, only one can be used, and it is impossible to use them at the same time. Feature E can be combined with feature C technically. Then, the solution of A+B+C+D should not be deemed to have been recorded because it is technically infeasible, and the solution of A+B+C+E should be deemed to have been recorded. BRIEF DESCRIPTION OF THE DRAWINGS

[0089] Figure 1 It is a schematic diagram of the structure of an ablation catheter of a vascular ablation system according to the first embodiment of the present application.

[0090] Figure 2 It is a schematic diagram of the overall structure of the vascular ablation system according to the first embodiment of the present application.

[0091] Figure 3 It is a schematic structural diagram of a conductive silicone ring pressure sensor in a vascular ablation system according to the first embodiment of the present application.

[0092] Figure 4 It is a schematic structural diagram of a piezoelectric film pressure sensor in a vascular ablation system according to the first embodiment of the present application.

[0093] Throughout the drawings, the same reference numerals are used to denote the same elements or structures, wherein:

[0094] 10: Temperature sensor

[0095] 20: Pressure sensor

[0096] 30: Heating body

[0097] 40: Peristaltic pump

[0098] 50: Electronic control components

[0099] 60: Foot switch DETAILED DESCRIPTION

[0100] In the following description, many technical details are provided to help readers better understand the present application. However, those skilled in the art can understand that the technical solution claimed in the present application can be implemented even without these technical details and various changes and modifications based on the following embodiments.

[0101] Description of some concepts:

[0102] Vascular Ablation System

[0103] Refers to a medical device used to treat vascular diseases (such as varicose veins), which usually uses radiofrequency energy to heat and ablate the diseased blood vessels, closing them and restoring normal blood flow. The vascular ablation system in this application mainly includes components such as ablation catheters, pressure sensors, and radiofrequency generators.

[0104] Radiofrequency ablation

[0105] A technique that uses radiofrequency energy to heat specific tissues, causing them to denature or coagulate, thereby achieving a therapeutic effect. In this application, radiofrequency ablation is used to treat varicose veins by heating the diseased blood vessels to close them.

[0106] Ablation Catheter

[0107] Refers to a catheter device used to transmit radiofrequency energy into a blood vessel, and the heating element of the catheter heats and ablates the blood vessel through radiofrequency energy. In this application, the ablation catheter also integrates a pressure sensor to detect the pressure of the catheter in the blood vessel.

[0108] Heating elements

[0109] A part of the ablation catheter that generates heat through radiofrequency energy, which acts on the blood vessel wall to close the diseased blood vessels, thereby achieving a therapeutic effect.

[0110] Pressure Sensors

[0111] It is used to detect the pressure of the ablation catheter in the blood vessel and feed back the pressure data to the radiofrequency generator. By real-time monitoring of pressure, it helps doctors determine the contact between the catheter and the blood vessel wall and ensure the safety and effectiveness of ablation treatment.

[0112] RF Generator

[0113] A device for generating radio frequency energy and delivering it to an ablation catheter. The radio frequency generator in the present application also receives pressure data from a pressure sensor, determines the contact between the catheter and the blood vessel wall based on the pressure data, and sends a corresponding indication signal to control the ablation process.

[0114] Tumescent fluid

[0115] Refers to the fluid injected around the blood vessel to be treated during vascular ablation treatment, usually anesthetic solution or saline. The role of the tumescent fluid is to make the blood vessel wall better contact with the heating element of the ablation catheter through external pressure to ensure effective heat transfer.

[0116] Temperature Sensor

[0117] It is used to detect the temperature of the catheter heating element during ablation treatment and feed it back to the RF generator to adjust the RF energy output according to temperature changes to ensure the accuracy of temperature control during treatment.

[0118] In order to make the objectives, technical solutions and advantages of the present application clearer, the implementation methods of the present application will be further described in detail below in conjunction with the accompanying drawings.

[0119] First embodiment

[0120] See also Figure 1 and Figure 2 , showing the following main components:

[0121] Heating body 30: shown in the figure as a long spiral structure on the catheter, which is used to generate heat for vascular ablation.

[0122] Pressure sensor 20: located in the middle and upper part of the spiral of the heating body 30, used to detect the contact pressure between the catheter and the blood vessel wall.

[0123] Temperature sensor 10: located in the lower middle of the spiral of the heating body 30, used to monitor the temperature during the ablation process.

[0124] Ablation catheter: The long tubular structure shown on the right side of the image is the main tool for performing ablation therapy.

[0125] Electronic control component 50: located at the lower left, including pressure control and temperature control modules, and is the core control unit of the system.

[0126] Pressure feedback and temperature feedback: connecting the electronic control component 50 and the ablation catheter for real-time data transmission.

[0127] Peristaltic pump 40: used to control the injection of swelling fluid.

[0128] Foot switch 60: used for the operator to control the start and stop of the system.

[0129] Tumescent fluid container: Located in the upper left corner, it stores tumescent fluid for injection around blood vessels.

[0130] Specifically, the vascular ablation system of this embodiment includes:

[0131] An ablation catheter, comprising:

[0132] a heating element for ablative treatment of blood vessels;

[0133] A pressure sensor 20, disposed at the heating element, for detecting the pressure exerted on the ablation catheter in the blood vessel;

[0134] A radio frequency generator is electrically connected to the ablation catheter, and the radio frequency generator is used to:

[0135] Receiving pressure data transmitted by the pressure sensor 20;

[0136] determining the contact condition between the heating element and the blood vessel wall according to the pressure data;

[0137] Based on the judgment result, determining whether ablation treatment conditions are met;

[0138] According to the comparison result between the pressure data and the preset pressure threshold, a corresponding indication signal is generated, wherein:

[0139] When the pressure data is lower than the preset pressure threshold, generating an indication signal for continuing to inject the tumescent fluid;

[0140] When the pressure data reaches or exceeds the preset pressure threshold, an indication signal is generated to stop injecting the tumescent fluid and start ablation therapy;

[0141] When it is determined that the ablation treatment conditions are met, radio frequency energy is provided to the heating element to perform ablation treatment.

[0142] Specifically, the vascular ablation system provided in this embodiment mainly includes key components such as an ablation catheter and a radio frequency generator. First, the ablation catheter is one of the core components of the system, which contains a heating element. The function of the heating element is to generate heat through radio frequency energy during the treatment process to ablate the blood vessels, close the diseased blood vessels, and thus achieve the treatment purpose.

[0143] In order to ensure the accuracy of treatment, the ablation catheter is also provided with a pressure sensor 20, which is specifically located at the heating element. Its function is to detect the pressure of the ablation catheter in the blood vessel in real time and feed back the pressure data to the radio frequency generator. The presence of the pressure sensor 20 enables the system to monitor the contact between the catheter and the blood vessel wall in real time, which is a key link in the entire ablation process.

[0144] The RF generator is the control center of the system. It not only provides RF energy to the heating element, but also receives the pressure data transmitted by the pressure sensor 20. Based on the pressure data, the RF generator can determine the contact between the heating element and the blood vessel wall. By comparing the pressure data with the preset pressure threshold, the RF generator can determine whether the conditions for ablation treatment are currently met.

[0145] When the pressure data is lower than the preset pressure threshold, the RF generator will generate an indication signal to continue injecting the tumescent fluid into the blood vessel. This is because when the catheter is not in sufficient contact with the blood vessel wall, the injection of the tumescent fluid can make the blood vessel wall and the catheter heating element fit closely through external pressure, thereby ensuring that heat can be effectively transferred. When the pressure data reaches or exceeds the preset pressure threshold, the RF generator will generate an indication signal to stop injecting the tumescent fluid, prompting the doctor to start ablation treatment.

[0146] After determining that the conditions for ablation treatment are met, the RF generator will provide RF energy to the heating element to start the ablation process. This design not only ensures the accuracy and safety of treatment, but also effectively avoids the problems of ablation failure, tissue damage or incomplete treatment caused by excessive or insufficient pressure.

[0147] In summary, the vascular ablation system of this embodiment can monitor the contact between the catheter and the blood vessel wall in real time through the synergistic effect of the pressure sensor 20 and the radio frequency generator in the ablation catheter, and accurately control the injection of the tumescent fluid and the output of the radio frequency energy according to the changes in the pressure data, thereby achieving safer and more effective vascular ablation treatment.

[0148] Optionally, the pressure sensor 20 is selected from at least one of the following:

[0149] Varistor;

[0150] Strain gauges;

[0151] Piezoelectric elements;

[0152] Capacitive pressure sensor;

[0153] Fiber optic pressure sensor;

[0154] Conductive silicone ring;

[0155] Piezoelectric film.

[0156] Optionally, the pressure sensor 20 is a conductive silicone ring, and the preparation method thereof includes:

[0157] A ring-shaped metal electrode is deposited on the surface of the PI tube at the winding gap or the head and tail of the ablation catheter by using a metal deposition technology;

[0158] Filling the gap with an FEP outer sleeve and liquid conductive silicone and solidifying the resulting gap into a conductive silicone ring;

[0159] Remove the FEP outer sleeve;

[0160] The windings are covered with insulating sleeves.

[0161] Optionally, the conductive silicone ring is connected to an identification resistor in the ablation catheter handle via a dial switch, and is used to determine pressure by identifying impedance changes during treatment.

[0162] Specifically, in the optional embodiment, the selection of the pressure sensor 20 has a certain flexibility. Specifically, the pressure sensor 20 can be selected from the following types, including: piezoresistors, strain gauges, piezoelectric elements, capacitive pressure sensors, optical fiber pressure sensors, conductive silicone rings, and piezoelectric films. These sensor types each have their own unique working principles and application scenarios, and can adapt to different clinical needs and usage environments.

[0163] Among them, the conductive silicone ring is a preferred type of pressure sensor. The conductive silicone ring has good flexibility and conductivity, and can sense pressure changes under slight deformation conditions. It is suitable for use in ablation catheters to accurately detect the pressure of the catheter in the blood vessel. The preparation process of the conductive silicone ring is relatively complicated, and the specific steps are as follows:

[0164] First, a ring-shaped metal electrode is deposited on the surface of the PI tube (polyimide tube) at the winding gap or the head and tail of the ablation catheter using metal deposition technology. The function of the metal electrode is to form a conductive loop and provide the necessary electrical signal transmission path for subsequent pressure detection. Next, an FEP (fluoroethylene propylene) outer sleeve is used in the gap of the winding, and liquid conductive silicone is injected into the gap. After solidification, the conductive silicone forms a complete silicone ring with good conductivity and pressure responsiveness. Then, the FEP outer sleeve is removed from the outside of the conductive silicone ring to expose the molded conductive silicone ring. Finally, an insulating sleeve is covered on the winding to ensure the safety of electronic components and the electrical insulation of the catheter.

[0165] The unique advantage of the conductive silicone ring lies in its flexibility and sensitivity, which can effectively detect pressure changes in the complex environment inside the blood vessel. In order to further enhance the accuracy of pressure detection, a mechanism is designed in this application to connect the conductive silicone ring to the identification resistor in the ablation catheter handle. This connection is achieved through a toggle switch. When the conductive silicone ring senses pressure changes, the impedance of the identification resistor will also change accordingly. The radio frequency generator determines the pressure of the catheter in the blood vessel by monitoring the change in impedance. This design can accurately identify the contact state between the catheter and the blood vessel wall, thereby providing doctors with real-time feedback information to ensure the accuracy and safety of ablation treatment.

[0166] Through this structural design, the conductive silicone ring can very sensitively sense the pressure changes of the catheter in the body and output pressure data through electrical signals, ensuring that the system can monitor the degree of fit between the catheter and the blood vessel wall in real time. Compared with traditional pressure monitoring methods, the use of conductive silicone rings not only improves the accuracy and sensitivity of detection, but its flexible material properties also greatly reduce the potential risk of trauma during catheter operation, making it suitable for complex vascular environments.

[0167] In summary, by using a conductive silicone ring as a pressure sensor 20, combined with metal deposition, liquid conductive silicone filling, identification resistors and other technical means, an innovative solution that can accurately detect changes in intravascular pressure is provided. This design greatly improves the real-time monitoring capability of the vascular ablation system and ensures the safety and effectiveness of the treatment process.

[0168] like Figure 3 As shown in the figure, the conductive silicone ring pressure sensor includes a coil, a conductive silicone ring, a metal electrode and an insulating sleeve. The conductive silicone ring is located in the gap of the coil, surrounded by metal electrodes on both sides and covered with an insulating sleeve on the outside. This structure enables the conductive silicone ring to sensitively sense pressure changes and transmit electrical signals through the metal electrodes.

[0169] Optionally, the pressure sensor 20 is a piezoelectric film, and the piezoelectric film is a ZnO film, which is attached to the surface of the ablation catheter by deposition.

[0170] Specifically, in the embodiment of the present application, in addition to the conductive silicone ring, a piezoelectric film is also an optional type of pressure sensor 20. Specifically, the piezoelectric film has the ability to convert mechanical pressure into an electrical signal, and can be used to detect the pressure of the ablation catheter in the blood vessel in real time. In this embodiment, the piezoelectric film material is a ZnO (zinc oxide) film, which is attached to the surface of the ablation catheter by deposition.

[0171] The unique property of piezoelectric materials is that they can generate electric charges when they are subjected to external pressure, thereby generating electrical signals. ZnO film, as a typical piezoelectric material, has good piezoelectric effect and mechanical flexibility, and is suitable for use in narrow and complex environments such as ablation catheters. By depositing ZnO film on the surface of the ablation catheter, the ablation catheter can use the piezoelectric effect of the film to sense the pressure on the catheter in real time, convert it into an electrical signal, and transmit it to the radio frequency generator for processing.

[0172] The ZnO film is deposited by physical or chemical vapor deposition technology to evenly cover the surface of the ablation catheter with ZnO material. The choice of deposition process ensures that the thickness of the ZnO film is precisely controllable, and its sensitivity and pressure responsiveness can be adjusted to meet different treatment needs. In addition, the film is very thin after being deposited on the catheter surface, and will not significantly increase the volume of the catheter or affect its flexibility, so it can adapt well to the complex operating environment within the blood vessel.

[0173] By using a piezoelectric film as the pressure sensor 20, the present application can achieve high-precision pressure detection. When the catheter is inserted into a blood vessel and subjected to pressure from the surrounding tissue, the ZnO film will generate tiny electrical signals due to the piezoelectric effect, and these electrical signals are transmitted to the radio frequency generator through the wire. The radio frequency generator determines the contact between the catheter and the blood vessel wall based on these signals, and controls the output of radio frequency energy and the injection amount of swelling fluid accordingly.

[0174] Compared with other types of pressure sensors 20, the advantages of ZnO piezoelectric film are its simple structure, fast response speed and high sensitivity. Since the film itself is relatively thin, it will not significantly affect the operational flexibility of the catheter and the comfort of the patient, and its high sensitivity to small pressure changes can ensure that the pressure changes of the ablation catheter in the blood vessel are sensed and fed back in time. Especially in the treatment process with high precision requirements, ZnO piezoelectric film can provide more detailed pressure monitoring, ensure the fit between the catheter and the blood vessel wall, avoid excessive or insufficient contact between the catheter and the tissue, and thus improve the success rate of treatment.

[0175] In addition, the stability and durability of the ZnO film enable it to maintain good performance during long-term treatment and is not easily affected by environmental factors (such as temperature changes or humidity), thus ensuring the continuity and reliability of pressure monitoring during ablation treatment.

[0176] In summary, by depositing ZnO piezoelectric film on the surface of the ablation catheter, this application provides an efficient and sensitive pressure detection method. This design can not only provide real-time feedback on the contact status between the catheter and the blood vessel wall, ensuring the accurate output of radio frequency energy, but also effectively improve the safety and effectiveness of vascular ablation treatment.

[0177] It should be pointed out that the piezoelectric film in the present application is not limited to ZnO material. In the embodiments of the present application, there are many other piezoelectric materials that are also suitable for the present system, such as polyvinylidene fluoride (PVDF), aluminum nitride (AlN), etc. These materials have their own characteristics and can be selected according to specific application requirements. For example, PVDF has good flexibility and chemical stability, and is suitable for use in situations where large deformations are required; while AlN has a higher piezoelectric coefficient and thermal stability, and is suitable for working in high temperature environments. Selecting different piezoelectric materials can make the system better adapt to different clinical needs and operating environments, and further improve the applicability and performance of the vascular ablation system. Regardless of the piezoelectric material selected, its core function is to achieve accurate detection of pressure through the piezoelectric effect, thereby ensuring the safety and effectiveness of ablation therapy.

[0178] like Figure 4 As shown in the figure, the piezoelectric film pressure sensor consists of a piezoelectric film directly attached to the surface of the coil, and an insulating sleeve is covered on the outside. The piezoelectric film can convert mechanical pressure into an electrical signal to achieve real-time monitoring of pressure.

[0179] Optionally, the system further comprises a display unit, which is electrically connected to the radio frequency generator and is used for:

[0180] displaying the indication signal;

[0181] Displaying the pressure data in real time;

[0182] showing the contact between the heating element and the blood vessel wall;

[0183] Displays the progress and parameters of ablation therapy.

[0184] Optionally, the radio frequency generator is also used for:

[0185] After the pressure data reaches or exceeds the preset pressure threshold, continuously monitoring the pressure data;

[0186] When the pressure data drops below the preset pressure threshold, the following operations are performed:

[0187] a) generate a warning signal;

[0188] b) Pause or adjust the RF energy output;

[0189] c) re-generating an indication signal for continuing to inject the swelling fluid;

[0190] Setting an adjustable pressure threshold range, including an upper threshold and a lower threshold;

[0191] When the pressure data exceeds the upper threshold, an indication signal for reducing the injection of tumescent fluid is generated.

[0192] Optionally, the RF generator further includes a storage unit, the storage unit is used to store a plurality of preset pressure thresholds, each preset pressure threshold corresponds to a different blood vessel type or treatment site. Optionally, the system further includes an input unit, the input unit is electrically connected to the RF generator, and is used to:

[0193] Receive user input, including:

[0194] a) Vascular type;

[0195] b) Treatment area;

[0196] c) Patient characteristics, such as age, gender, weight, etc.;

[0197] Provides preset vessel type and treatment site options for users to choose from;

[0198] Allows the user to manually enter or adjust pressure thresholds and RF parameters;

[0199] Wherein, the radio frequency generator is based on the information received by the input unit:

[0200] Selecting a corresponding preset pressure threshold and radio frequency parameter from a storage unit;

[0201] Automatically adjust the selected preset pressure threshold and radiofrequency parameters according to patient characteristics;

[0202] During treatment, pressure thresholds and RF parameters are adjusted based on real-time input from the user.

[0203] Specifically, in the embodiments of the present application, the RF generator is not only a core component for controlling the output of RF energy, but also includes a storage unit, which plays an important role in the system. The storage unit can store multiple preset pressure thresholds, each of which is optimized for different blood vessel types or treatment sites. Specifically, different types of blood vessels (such as superficial veins, deep veins, etc.) and different treatment sites (such as legs, arms, etc.) may have significantly different pressure requirements. Storing preset pressure thresholds can help doctors select the most appropriate parameters according to the specific treatment situation, thereby improving the accuracy and safety of treatment.

[0204] To make the system more intelligent and personalized, the present application also provides an input unit, which is electrically connected to the RF generator and allows doctors or operators to input information related to patients and treatment. The input unit can receive the following types of information:

[0205] Vessel type: Different vessel types have different anatomical structures and physiological characteristics. Entering the vessel type helps the system select the corresponding preset pressure threshold and RF parameters.

[0206] Treatment site: The thickness and reactivity of blood vessels in different parts of the body vary, so the choice of treatment site is also very important for the setting of RF parameters.

[0207] Patient characteristics: The system can input personalized parameters such as the patient's age, gender, weight, etc. These factors may affect the characteristics of the blood vessels and the difficulty of treatment, so they are also important for the selection of pressure threshold and RF energy.

[0208] The system is designed with a user-friendly interface that allows doctors to select preset vessel types and treatment site options through the input unit. To increase flexibility, users can also manually input or adjust pressure thresholds and radiofrequency parameters to deal with special situations or adjust treatment strategies. The input unit not only provides ease of operation, but also provides doctors with flexible adjustment space to ensure dynamic adjustments during treatment based on real-time conditions.

[0209] During the operation of the system, the RF generator will call the preset pressure threshold and RF parameters corresponding to the specific treatment scenario from the storage unit according to the information received by the input unit. For example, for superficial vein ablation in the leg, the system will automatically select the optimal pressure threshold and RF parameters for that part to ensure the treatment effect. At the same time, the RF generator also has the ability to automatically adjust. It can fine-tune the selected preset parameters according to the input patient characteristics (such as age, weight, etc.) to further personalize the treatment.

[0210] In addition, the system allows doctors to adjust the pressure threshold and radiofrequency parameters according to real-time conditions during treatment. This real-time adjustment capability is critical because the state of the blood vessels may change during the actual treatment process. Doctors can optimize the parameters based on actual feedback to ensure the safety and effectiveness of the treatment.

[0211] The above method has the following technical effects:

[0212] Personalized treatment: Through multiple pressure thresholds preset in the storage unit, the system can automatically select the most suitable parameters according to the input blood vessel type and treatment site. At the same time, the system can also fine-tune the pressure threshold and radiofrequency parameters according to the individual characteristics of the patient to ensure the personalization and accuracy of the treatment plan.

[0213] Improve operational flexibility: The input unit allows doctors to manually input or adjust parameters to meet special treatment needs. The system not only provides automatic selection of preset parameters, but also allows users to make real-time adjustments based on actual conditions, effectively improving operational flexibility.

[0214] Real-time adjustment capability: During treatment, doctors can dynamically adjust pressure thresholds and radiofrequency parameters based on the patient's real-time response. This design enables the system to adapt to changes that occur during treatment, ensuring treatment effectiveness while reducing risks.

[0215] Optimize treatment effect: Because the system can select and adjust parameters according to different blood vessel types, treatment sites and individual patient characteristics, the accuracy and safety of treatment have been significantly improved. By automatically adjusting the pressure threshold and radiofrequency parameters, the system can ensure the best contact between the ablation catheter and the blood vessel wall, thereby improving the success rate of ablation treatment.

[0216] In summary, the present application realizes the function of the radio frequency generator to select and adjust treatment parameters according to different situations by combining the storage unit and the input unit. This design not only improves the intelligence level of the system, but also enables doctors to flexibly adjust according to the individual needs of patients, thereby ensuring the safety, accuracy and effectiveness of vascular ablation treatment.

[0217] Optionally, the radio frequency generator is also used for:

[0218] Record data during ablation therapy, including:

[0219] a) Real-time changes in pressure data;

[0220] b) RF energy output parameters;

[0221] c) duration of treatment;

[0222] d) temperature changes (if the system includes a temperature sensor 10);

[0223] Analyze recorded data, including:

[0224] a) Calculate the statistical characteristics of pressure data, such as average value, maximum value, minimum value and fluctuation range;

[0225] b) Identify abnormal change points in pressure data;

[0226] c) evaluate the correlation between RF energy output and pressure changes;

[0227] Generates comprehensive treatment reports including:

[0228] a) Data visualization, such as pressure-time graph;

[0229] b) summary of treatment parameters;

[0230] c) Records of abnormal events and handling measures;

[0231] d) Preliminary evaluation of treatment efficacy;

[0232] Provide report export and sharing functions, supporting multiple formats such as PDF, CSV, etc.;

[0233] Store treatment data and reports in a secure database to support subsequent query and analysis.

[0234] Specifically, the RF generator of the optional embodiment described above also has data recording and analysis functions. It can record key data during ablation therapy, including pressure changes, RF energy output, treatment time, and temperature changes (if there is a temperature sensor 10). By analyzing these data, the average, maximum, and minimum values ​​of pressure are generated, abnormal pressure changes are identified, and the correlation between RF energy and pressure is evaluated.

[0235] The system can generate treatment reports, including pressure-time curves, treatment parameter summaries, abnormal event records, and preliminary efficacy evaluations. The reports can be exported to PDF or CSV formats and stored in a secure database for subsequent query and analysis.

[0236] Optionally, the ablation catheter further includes a temperature sensor 10 for detecting the temperature during the ablation treatment; the radio frequency generator adjusts the radio frequency energy provided to the heating element according to the detected temperature.

[0237] Specifically, the ablation catheter in the present application may be optionally equipped with a temperature sensor 10 for real-time temperature detection during ablation therapy. The temperature sensor 10 can monitor temperature changes near the heating element to ensure that ablation therapy is performed within a safe temperature range.

[0238] The RF generator automatically adjusts the RF energy output provided to the heating element according to the feedback data from the temperature sensor 10. If the detected temperature is too high, the system will reduce the RF energy to prevent overheating of the tissue; if the temperature is too low, the energy output will be increased to ensure the ablation effect. This design improves the safety and accuracy of treatment and prevents treatment failure or tissue damage caused by overheating or underheating.

[0239] Working principle:

[0240] The vascular ablation system of the above embodiment achieves accurate and safe ablation treatment through the following working principles:

[0241] Catheter insertion and positioning: At the beginning of treatment, the ablation catheter is inserted into the patient's blood vessel and the catheter's heating element is positioned in the target diseased vascular area.

[0242] Pressure monitoring and feedback: The pressure sensor 20 on the catheter monitors the contact pressure between the catheter and the blood vessel wall in real time. The pressure data is transmitted to the radio frequency generator, which determines whether the catheter is in full contact with the blood vessel wall based on a preset pressure threshold.

[0243] If the pressure is lower than the threshold, the system will generate an indication signal to continue injecting the tumescent fluid to ensure that the catheter is in close contact with the blood vessel wall.

[0244] When the pressure reaches or exceeds the threshold, the system generates an indication signal to stop injecting the tumescent fluid and prepare for ablation therapy.

[0245] Temperature monitoring and energy regulation (optional): If the catheter is equipped with a temperature sensor 10, it will detect the temperature of the heating element in real time during the ablation process. The RF generator dynamically adjusts the RF energy output according to the temperature data to prevent overheating or underheating.

[0246] Radiofrequency ablation: After confirming that the catheter is in good contact with the vessel wall and the temperature is appropriate, the radiofrequency generator provides radiofrequency energy to the heating element. The radiofrequency energy causes the heating element to generate heat, ablating the diseased blood vessel and promoting its closure.

[0247] Data recording and analysis: During the treatment process, the system records data such as pressure, RF energy, temperature (if any) and treatment time, and performs real-time analysis to ensure stability and safety during the treatment.

[0248] Treatment completion and evaluation: After the ablation treatment is completed, the system generates a treatment report, including pressure change curves, treatment parameters, abnormal event records, etc., to provide doctors with detailed treatment process data and preliminary evaluation of efficacy.

[0249] By integrating pressure monitoring, temperature control and radiofrequency energy regulation, this system ensures the accuracy and safety of ablation therapy, effectively improving the success rate of treatment and reducing the risk of complications.

[0250] The advantages of the above implementation are as follows:

[0251] The above embodiment provides a vascular ablation system, which can effectively solve the uncertainty problem caused by the injection of tumescent fluid relying on the doctor's experience in the prior art by integrating a pressure sensor and a radio frequency generator in the ablation catheter, and has the following significant technical effects:

[0252] Real-time monitoring of the contact between the catheter and the blood vessel wall

[0253] The pressure sensor can detect the pressure of the catheter in the blood vessel in real time and feed the pressure data back to the RF generator. The RF generator determines the contact between the catheter heating element and the blood vessel wall based on the pressure data. This technical means can help doctors accurately grasp the degree of fit between the catheter and the blood vessel wall, ensure that the catheter is in close contact with the blood vessel wall during treatment, avoid overheating or underheating, and thus improve the treatment effect.

[0254] Eliminate reliance on experience and achieve precise injection control

[0255] Through the feedback of the pressure sensor, the RF generator can send an indication signal according to the preset pressure threshold, prompting the doctor to continue or stop injecting the tumescent fluid. This design avoids the excessive reliance of traditional methods on the doctor's experience, reduces the problem of inconsistent treatment effects caused by differences in experience and judgment of different doctors, and realizes precise control of the vascular ablation process.

[0256] Improving the safety and effectiveness of ablation therapy

[0257] Real-time monitoring and feedback of pressure data enables the system to issue warning signals in time when the pressure is insufficient or excessive, and adjust the RF energy output. When the pressure is insufficient, the system will prompt to continue injecting the tumescent fluid; when the pressure is too high, the system will issue an instruction signal to stop injecting the tumescent fluid. This functional design can effectively avoid incomplete underheating treatment due to too low contact pressure between the catheter and the blood vessel wall, or tissue damage or catheter adhesion caused by excessive pressure, significantly improving the safety and effectiveness of ablation treatment.

[0258] Personalized treatment parameter adjustment

[0259] The above-mentioned embodiment, through the cooperation of the input unit and the storage unit, allows the doctor to make personalized pressure threshold and radio frequency parameter adjustments according to the patient's blood vessel type, treatment site and personal characteristics (such as age, gender, weight, etc.), so that the system can provide customized treatment plans according to different patient conditions, further improving the targetedness and accuracy of the treatment.

[0260] Data recording and analysis function

[0261] The system has data recording and analysis functions, which can record key parameters such as changes in pressure data, radiofrequency energy output, and treatment time during treatment, and generate detailed treatment reports. This function enables doctors to conduct a comprehensive evaluation of the treatment process, helps optimize and improve subsequent treatment plans, and also provides data support for patients' treatment effects.

[0262] Temperature monitoring and energy regulation

[0263] By adding a temperature sensor, the system can monitor temperature changes during ablation in real time and automatically adjust the output of RF energy based on temperature feedback. This design ensures that when the contact between the catheter and the blood vessel wall is uneven, the heating element can still avoid local overheating or underheating through temperature control, further improving the accuracy and safety of treatment.

[0264] It should be noted that all documents mentioned in this application are cited as references in this application, just as each document is cited as reference separately. In addition, it should be understood that after reading the above teaching content of this application, those skilled in the art can make various changes or modifications to this application, and these equivalent forms also fall within the scope defined by the claims attached to this application.

Claims

1. A vascular ablation system, characterized in that: include: An ablation catheter, comprising: a heating element for ablative treatment of blood vessels; A pressure sensor, disposed at the heating element, for detecting the pressure exerted on the ablation catheter in the blood vessel; A radio frequency generator is electrically connected to the ablation catheter, and the radio frequency generator is used to: receiving pressure data transmitted by the pressure sensor; determining the contact condition between the heating element and the blood vessel wall according to the pressure data; Based on the judgment result, determining whether ablation treatment conditions are met; According to the comparison result between the pressure data and the preset pressure threshold, a corresponding indication signal is generated, wherein: When the pressure data is lower than the preset pressure threshold, generating an indication signal for continuing to inject the tumescent fluid; When the pressure data reaches or exceeds the preset pressure threshold, an indication signal is generated to stop injecting the tumescent fluid and start ablation therapy; When it is determined that the ablation treatment conditions are met, radio frequency energy is provided to the heating element to perform ablation treatment.

2. The vascular ablation system according to claim 1, characterized in that: The pressure sensor is selected from at least one of the following: Varistor; Strain gauges; Piezoelectric elements; Capacitive pressure sensor; Fiber optic pressure sensor; Conductive silicone ring; Piezoelectric film.

3. The vascular ablation system according to claim 2, characterized in that: The pressure sensor is a conductive silicone ring, and its preparation method includes: A ring-shaped metal electrode is deposited on the surface of the PI tube at the winding gap or the head and tail of the ablation catheter by using a metal deposition technology; Filling the gap with an FEP outer sleeve and liquid conductive silicone and solidifying the gap into a conductive silicone ring; Remove the FEP outer sleeve; The windings are covered with insulating sleeves.

4. The vascular ablation system according to claim 3, characterized in that: The conductive silicone ring is connected to the identification resistor in the ablation catheter handle through a dial switch, and is used to judge the pressure by identifying the impedance change during treatment.

5. The vascular ablation system according to claim 2, characterized in that: The pressure sensor is a piezoelectric film, and the piezoelectric film is attached to the surface of the ablation catheter by deposition.

6. The vascular ablation system according to claim 1, characterized in that: The device further comprises a display unit, which is electrically connected to the radio frequency generator and is used for: displaying the indication signal; Displaying the pressure data in real time; showing the contact between the heating element and the blood vessel wall; Displays the progress and parameters of ablation therapy.

7. The vascular ablation system according to claim 1, characterized in that: The radio frequency generator is also used for: After the pressure data reaches or exceeds the preset pressure threshold, continuously monitoring the pressure data; When the pressure data drops below the preset pressure threshold, the following operations are performed: a) generate a warning signal; b) Pause or adjust the RF energy output; c) re-generating an indication signal for continuing to inject the swelling fluid; Setting an adjustable pressure threshold range, including an upper threshold and a lower threshold; When the pressure data exceeds the upper threshold, an indication signal for reducing the injection of tumescent fluid is generated.

8. The vascular ablation system according to claim 1, characterized in that: The radio frequency generator further comprises a storage unit, which is used to store a plurality of preset pressure thresholds, each of which corresponds to a different blood vessel type or treatment site.

9. The vascular ablation system according to claim 8, characterized in that: The device further comprises an input unit, which is electrically connected to the radio frequency generator and is used for: Receive user input, including: a) Vascular type; b) Treatment area; c) Patient characteristics, such as age, gender, weight, etc.; Provides preset vessel type and treatment site options for users to choose from; Allows the user to manually enter or adjust pressure thresholds and RF parameters; Wherein, the radio frequency generator is based on the information received by the input unit: Selecting a corresponding preset pressure threshold and radio frequency parameter from a storage unit; Automatically adjust the selected preset pressure threshold and radiofrequency parameters according to patient characteristics; During treatment, pressure thresholds and RF parameters are adjusted based on real-time input from the user.

10. The vascular ablation system according to claim 1, characterized in that: The radio frequency generator is also used for: Record data during ablation therapy, including: a) Real-time changes in pressure data; b) RF energy output parameters; c) duration of treatment; d) Temperature changes (if the system includes a temperature sensor); Analyze recorded data, including: a) Calculate the statistical characteristics of pressure data, such as average value, maximum value, minimum value and fluctuation range; b) Identify abnormal change points in pressure data; c) evaluate the correlation between RF energy output and pressure changes; Generates comprehensive treatment reports including: a) Data visualization, such as pressure-time graph; b) summary of treatment parameters; c) Records of abnormal events and handling measures; d) Preliminary evaluation of treatment efficacy; Provide report export and sharing functions, supporting multiple formats such as PDF, CSV, etc.; Store treatment data and reports in a secure database to support subsequent query and analysis.

11. The vascular ablation system according to claim 1, characterized in that: The ablation catheter also includes a temperature sensor for detecting the temperature during the ablation treatment process; the radio frequency generator adjusts the radio frequency energy provided to the heating element according to the detected temperature.

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