Endoluminal radiofrequency ablation system

Abstract

The application relates to the field of medical equipment and discloses an intracavitary radiofrequency ablation system. The system comprises a radiofrequency generator, a catheter (provided with a heating element, a pressure sensor and a temperature sensor), a processor and a display. The safety and accuracy of the treatment process are ensured by monitoring the temperature and pressure in real time and dynamically adjusting the radiofrequency energy output power. The system can automatically adjust the treatment parameters according to the real-time shrinkage of the cavity tissue, prevent excessive heating, reduce the damage to normal tissue, provide intuitive tissue shrinkage feedback and improve the treatment effect.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, particularly to radiofrequency ablation technology. BACKGROUND

[0002] As a minimally invasive treatment method, radiofrequency ablation technology has been widely used in the treatment of heart disease, tumors and other diseases in recent years. A radiofrequency ablation system usually consists of a radiofrequency generator, a catheter, a temperature sensor and other monitoring devices. The system transmits heat energy to the target tissue by heating the catheter's heating element with radiofrequency energy, thereby achieving ablation of the diseased tissue. However, the existing radiofrequency ablation system still has some technical limitations and hidden dangers in practical application, which makes it difficult to fully guarantee the safety and accuracy during treatment.

[0003] Firstly, the traditional radiofrequency ablation system mainly relies on temperature sensors to feedback control the temperature of the catheter heating element. However, temperature feedback is usually only single-point monitoring. When the temperature sensor fails or the feedback is delayed, the system cannot timely perceive the contact between the catheter and the tissue, which may cause the heating element to continue to output energy, eventually leading to excessive heating and burning of the surrounding normal tissue, causing serious medical risks.

[0004] Secondly, the existing radiofrequency ablation system mostly uses fixed treatment temperature and treatment time, which cannot be dynamically adjusted according to the real-time contraction of the cavity tissue. Due to the different tissue characteristics and reactions of each patient, fixed temperature and time settings may lead to over-treatment or under-treatment, affecting the treatment effect. For example, when the cavity tissue has completely contracted, the system still continues to heat according to the preset target temperature and time, which is easy to cause excessive heat energy, thereby damaging normal tissue and increasing the risk of complications.

[0005] In addition, the existing system lacks intuitive feedback on the contraction of the cavity tissue. During the operation, the doctor can only rely on external imaging devices such as ultrasound to observe the contact between the catheter and the cavity tissue, and cannot obtain the contraction changes of the tissue before and after treatment in real time. This indirect feedback mechanism not only increases the difficulty of the doctor's operation, but also makes the monitoring during the treatment process less accurate, increasing the complexity and uncertainty of the operation.

[0006] In view of the above problems, the existing radiofrequency ablation technology needs to be improved to improve the real-time monitoring capability of the system on temperature and pressure during treatment, to ensure the safety and accuracy of the contact between the catheter and the tissue. In addition, the system should have the ability to dynamically adjust the treatment parameters according to the actual contraction of the tissue, to prevent damage to normal tissue due to excessive heating. At the same time, the system should also provide intuitive feedback on tissue contraction, so that the doctor can clearly understand the changes of the tissue before and after treatment, thereby improving the operation effect and reducing the operation risk. SUMMARY

[0007] The present application aims to provide an intraluminal radiofrequency ablation system to solve the problems raised in the background.

[0008] The present application discloses an intraluminal radiofrequency ablation system, which comprises:

[0009] a radiofrequency generator for generating radiofrequency energy and transmitting it to a heating element of a catheter;

[0010] a catheter, comprising: a heating element for receiving the radiofrequency energy and heating luminal tissue; a pressure sensor arranged at the heating element for detecting the contact pressure of the heating element with luminal tissue; and a temperature sensor arranged at the heating element for detecting the temperature of the heating element;

[0011] a processor electrically connected with the radiofrequency generator, pressure sensor and temperature sensor, and configured to:

[0012] (a) acquire an initial pressure value P1 and an initial temperature value T1;

[0013] (b) control the radiofrequency generator to output radiofrequency energy to the heating element so that its temperature rises to a second temperature value T2, and acquire a second pressure value P2 at this time;

[0014] (c) calculate a pressure-temperature function relationship according to the initial pressure value P1, initial temperature value T1, second pressure value P2 and second temperature value T2;

[0015] (d) calculate a first pressure threshold P3 and a second pressure threshold P4 at a preset target temperature based on the pressure-temperature function relationship, wherein P4 is greater than P3;

[0016] (e) control the heating element to rise to the preset target temperature, and monitor the current pressure value P in real time;

[0017] (f) when the current pressure value P reaches the first pressure threshold P3, lower the target temperature of the heating element to a new target temperature lower than the preset target temperature;

[0018] (g) when the current pressure value P exceeds the second pressure threshold P4 and the current temperature is lower than the preset target temperature, control the radiofrequency generator to stop outputting radiofrequency energy;

[0019] a display electrically connected with the processor for displaying the pressure value change before and after treatment to reflect the shrinkage of luminal tissue.

[0020] In a preferred embodiment, the processor is further configured to:

[0021] According to the initial pressure value P1, the initial temperature value T1, the second pressure value P2 and the second temperature value T2, a pressure value P at a current temperature T is calculated by using a pressure-temperature function relationship, which is:

[0022] P = [(P2-P1) / (T2-T1)]xT+[(P1xT2-P2xT1) / (T2-T1)]+a

[0023] wherein a is a correction constant, and T is the current temperature.

[0024] In one preferred embodiment, the processor is further configured to:

[0025] In step (d), the second pressure threshold P4 is calculated according to the formula P4 = P3xK, wherein K is a preset constant greater than 1.

[0026] In one preferred embodiment, the processor is further configured to:

[0027] In step (f), the new target temperature Tp is calculated according to the formula Tp = b x Ts, wherein Ts is the preset target temperature, and b is a preset coefficient greater than 0 and less than 1.

[0028] In one preferred embodiment, the processor is further configured to:

[0029] In step (f), after the target temperature of the heating element is lowered to the new target temperature, the heating element is controlled to maintain the new target temperature until a preset treatment time ends; wherein,

[0030] The processor is further configured to continuously monitor the current pressure value P during the maintenance of the new target temperature, and perform step (g) when the current pressure value P exceeds the second pressure threshold P4.

[0031] In one preferred embodiment, the processor is further configured to:

[0032] In step (g), when the radio frequency generator is controlled to stop outputting the radio frequency energy, the following operations are simultaneously performed:

[0033] (i) displaying abnormal warning information through the display, the abnormal warning information including a prompt that the current pressure value P exceeds the second pressure threshold P4;

[0034] (ii) generating an audible alarm sound; and

[0035] (iii) recording the time of the abnormality, the current pressure value P and the current temperature value into a system log.

[0036] In a preferred embodiment, the system further comprises:

[0037] a user input interface electrically connected to the processor, the user input interface being configured to:

[0038] (i) receive a preset target temperature Ts input by a user;

[0039] (ii) receive a preset treatment time input by a user;

[0040] (iii) receive a coefficient b input by a user, where 0 < b < 1, for calculating a new target temperature Tp;

[0041] (iv) receive a constant K input by a user, where K > 1, for calculating a second pressure threshold P4;

[0042] wherein the processor is further configured to perform steps (a) to (g) in claim 1 according to the parameters received from the user input interface, and use these parameters for corresponding calculations and controls during the execution.

[0043] In a preferred embodiment, the display is configured to:

[0044] display the following information in real time:

[0045] (i) the current pressure value P;

[0046] (ii) the current temperature value T;

[0047] (iii) the target temperature value, including the preset target temperature Ts and the new target temperature Tp (if applicable);

[0048] (iv) the remaining treatment time;

[0049] (v) the first pressure threshold P3 and the second pressure threshold P4;

[0050] (vi) the output power of the radio frequency generator;

[0051] (vii) the system running status, including normal operation, cooling stage or abnormal stop, etc. status indication.

[0052] In a preferred embodiment, the heating element comprises:

[0053] (i) a thermocouple for measuring the temperature of the heating element in real time and transmitting the measurement results to the processor;

[0054] (ii) a heating element winding coaxially surrounding the thermocouple, the heating element winding being configured to receive radio frequency energy from the radio frequency generator, convert it into heat and distribute it uniformly;

[0055] (iii) an insulating layer, coated on the outside of the heating element winding, for electrical insulation and heat retention;

[0056] (iv) a flexible outer shell, made of biocompatible material, covering the entire heating element structure.

[0057] In one preferred embodiment, the system further comprises: a swelling liquid injection device, electrically connected to the processor, the swelling liquid injection device is configured to:

[0058] (i) inject a preset volume of swelling liquid into the cavity tissue;

[0059] (ii) send an injection completion signal to the processor;

[0060] wherein the processor is further configured to:

[0061] (a) receive the injection completion signal;

[0062] (b) in response to the injection completion signal, continuously monitor the contact condition between the heating element and the cavity tissue by the pressure sensor;

[0063] (c) based on the measurement results of the pressure sensor, calculate the contact area percentage of the heating element and the cavity tissue;

[0064] (d) control the display to display the contact condition in real time, including: numerical display of the contact area percentage, and / or graphical representation of the contact state;

[0065] (e) when the contact area percentage is lower than a preset threshold, control the display to issue a warning signal.

[0066] In one preferred embodiment, the processor is further configured to dynamically adjust the output power of the radio frequency energy, specifically including:

[0067] (a) set an initial radio frequency output power value Pinitial;

[0068] (b) during the treatment process, continuously obtain the current temperature value T and the current pressure value P at a preset sampling frequency;

[0069] (c) based on the current temperature value T, the current pressure value P, the target temperature Ts and the first pressure threshold P3, calculate the power adjustment factor a, wherein:

[0070] a = f(T, P, Ts, P3), f is a preset power adjustment function;

[0071] (d) according to the power adjustment factor a, calculate a new radio frequency output power value Pnew:

[0072] Pnew = Pcurrent x a

[0073] where Pcurrent is the current radio frequency output power value;

[0074] (e) applying the new radio frequency output power value Pnew to the radio frequency generator to dynamically adjust the radio frequency energy output;

[0075] (f) setting an upper limit value Pmax and a lower limit value Pmin for power adjustment, ensuring that:

[0076] Pmin < Pnew < Pmax

[0077] where Pmin and Pmax are predefined safe power ranges;

[0078] (g) triggering a rapid power adjustment when any of the following conditions occur:

[0079] (i) when the temperature rapidly rises and exceeds a preset safe temperature threshold Tsafe, immediately reducing the output power to Pmin;

[0080] (ii) when the pressure rapidly rises and exceeds a first pressure threshold P3, reducing the output power to a preset percentage β% of the current power (where 0 < β < 100);

[0081] (h) after each power adjustment, recording relevant data of the power adjustment, including but not limited to: adjustment time, power before adjustment, power after adjustment, current temperature, current pressure, and power adjustment factor a;

[0082] (i) generating power adjustment curves and temperature-pressure change curves based on the recorded data, and displaying these curves to the user through the display at the end of the treatment for analysis;

[0083] (j) periodically optimizing the power adjustment function f based on historical treatment data and machine learning algorithms to improve the system's adaptability and treatment effectiveness.

[0084] The embodiments of the present application have the following technical effects:

[0085] 1. Accurate control of radio frequency energy output to avoid tissue damage

[0086] By monitoring temperature and pressure in real time and dynamically adjusting radio frequency energy output power, the system can quickly respond when tissue contact pressure changes, prevent excessive energy transmission, and avoid tissue burns caused by excessive heating. Especially in the case of rapid temperature rise or pressure exceeding the threshold, the system can immediately reduce the output power to ensure the safety and accuracy of the treatment.

[0087] 2. Real-time feedback on the shrinkage of the cavity tissue, improving treatment effectiveness

[0088] The system obtains the contact pressure between the catheter and the cavity tissue through the pressure sensor, and visually displays the shrinkage of the cavity tissue before and after treatment through the display. This real-time feedback not only helps doctors better understand the treatment process, but also allows them to take timely measures when the cavity tissue shrinks abnormally, reducing the risk of surgery.

[0089] 3. Automatic adjustment of treatment temperature to avoid excessive heat energy

[0090] The system automatically calculates and adjusts the treatment temperature based on the pressure changes at different temperature points. When the pressure reaches the set threshold, the system will lower the target temperature and maintain an appropriate temperature level according to the treatment time, avoiding excessive heating and reducing damage to normal tissues.

[0091] 4. Abnormal detection and alarm function to improve operational safety

[0092] When abnormal conditions occur during treatment (such as pressure or temperature exceeding the set threshold), the system can stop the output of radiofrequency energy in time, and issue an abnormal warning through the display and alarm, prompting the doctor to take appropriate measures. This mechanism greatly improves the operational safety of the system and reduces medical accidents caused by equipment failure or operational errors.

[0093] 5. Efficient data recording and analysis to optimize treatment plans

[0094] The system records temperature, pressure, power changes and other data during each treatment, and generates related curves for user analysis. Through these data, doctors can more accurately evaluate treatment effectiveness and optimize subsequent treatment plans based on historical data. In addition, the system can also combine machine learning algorithms to automatically optimize power adjustment functions, further improving the adaptive ability and effectiveness of treatment.

[0095] 6. Flexible power adjustment mechanism to adapt to different clinical needs

[0096] The system sets upper and lower limits for power adjustment, and dynamically adjusts the radiofrequency output power through the power adjustment factor. This flexible power adjustment mechanism allows the system to adapt to different treatment environments and patient individual differences, ensuring that the energy output during treatment is always within a safe and effective range.

[0097] 7. Reduce manual operation of doctors, improve surgical efficiency

[0098] Through automatic temperature and pressure monitoring, power adjustment and abnormality processing, the system reduces the manual operation of the doctor and displays the key data related to the treatment in real time through the display, helping the doctor to complete the operation more efficiently. This not only improves the operation efficiency, but also reduces the error caused by manual operation.

[0099] In summary, the present application significantly improves the safety, accuracy and efficiency of radiofrequency ablation treatment, and provides a more reliable treatment tool for clinical use.

[0100] A large number of technical features are described in the specification of the present application, which are distributed in various technical solutions. If all possible combinations of technical features (i.e. technical solutions) of the present application are listed, the specification will be too long. In order to avoid this problem, each technical feature disclosed in the above invention content, each technical feature disclosed in the following embodiments and examples, and each technical feature disclosed in the drawings can be freely combined to form various new technical solutions (these technical solutions are considered to have been described in the specification), unless such combination of technical features is technically infeasible. For example, features A+B+C are disclosed in one example, features A+B+D+E are disclosed in another example, features C and D are equivalent technical means that play the same role, and can only be used at the same time, and feature E can be combined with feature C technically. Therefore, the scheme of A+B+C+D should not be considered as having been described because it is technically infeasible, and the scheme of A+B+C+E should be considered as having been described. BRIEF DESCRIPTION OF DRAWINGS

[0101] Figure 1 is a schematic diagram of a heating element structure of an intracavitary radiofrequency ablation system according to the first embodiment of the present application.

[0102] Figure 2 is a schematic diagram of temperature and pressure change curves of an intracavitary radiofrequency ablation system according to the embodiment of the present application.

[0103] Figure 3 is a schematic diagram of temperature control of an intracavitary radiofrequency ablation system according to the embodiment of the present application.

[0104] In all the drawings, the same reference signs are used to represent the same elements or structures, wherein:

[0105] 10: pressure sensor;

[0106] 20: thermocouple;

[0107] 30: heating element winding. DETAILED DESCRIPTION

[0108] In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. However, it will be apparent to one ordinarily skilled in the art that the application can be practiced without the specific details and that numerous implementation variations and modifications can be possible.

[0109] Explanation of partial concepts:

[0110] Catheter RF ablation system, in the present application, refers to a medical device system used for tissue ablation treatment in the human body cavity. It uses RF energy to heat the catheter tip and ablate specific tissues.

[0111] RF generator: a device that generates high-frequency current, used to transmit RF energy to the catheter.

[0112] Heating element, in the present application, refers to the component located at the catheter tip, which receives RF energy and converts it into heat energy for tissue ablation.

[0113] Pressure sensor, in the present application, is set at the catheter heating element to detect the contact pressure between the heating element and the cavity tissue.

[0114] Temperature sensor, in the present application, is set at the catheter heating element to detect the temperature of the heating element.

[0115] Pressure-temperature function, in the present application, refers to a mathematical formula describing the relationship between pressure and temperature, used to predict and control the treatment process.

[0116] Pressure threshold (P3 and P4), in the present application, refers to the preset pressure value used to trigger the automatic adjustment or stop operation of the system. P3 is the first pressure threshold, and P4 is the second pressure threshold.

[0117] Target temperature (Ts), in the present application, refers to the preset ideal treatment temperature.

[0118] New target temperature (Tp), in the present application, refers to the new target temperature automatically lowered by the system when the pressure reaches the first threshold.

[0119] Swelling liquid, in the present application, refers to the liquid injected into the cavity in some surgeries to expand the tissue or improve visibility.

[0120] Power adjustment factor (a), in the present application, refers to the calculation factor used to dynamically adjust the RF output power.

[0121] Thermocouple: a temperature sensor used to accurately measure the temperature of the heating element.

[0122] Heating element winding: the main part of the heating element, used to receive RF energy and convert it into heat.

[0123] Contact area percentage, in this application, refers to the percentage of the actual contact area of the heating element with the cavity tissue to the ideal contact area, used to evaluate the treatment effect.

[0124] Safety temperature threshold (Tsafe), in this application, refers to the preset maximum safety temperature, which will trigger the system's rapid power adjustment when exceeded.

[0125] In order to make the purpose, technical scheme and advantages of the present application more clear, the embodiments of the present application will be further described in detail below with reference to the drawings.

[0126] The first embodiment of the present application relates to an intracavity radiofrequency ablation system, the structure of the core component heating element is as shown in Figure 1 The system comprises:

[0127] RF generator, used to generate RF energy and transmit it to the heating element of the catheter;

[0128] Catheter, the catheter comprises: a heating element for receiving the RF energy and heating the cavity tissue; a pressure sensor 10 arranged at the heating element for detecting the contact pressure of the heating element with the cavity tissue; a temperature sensor arranged at the heating element for detecting the temperature of the heating element;

[0129] Processor, electrically connected with the RF generator, pressure sensor 10 and temperature sensor, see Figure 2 and Figure 3 , the processor is configured to:

[0130] (a) obtain the initial pressure value P1 and the initial temperature value T1;

[0131] (b) control the RF generator to output RF energy to the heating element, so that its temperature rises to the second temperature value T2, and obtain the second pressure value P2 at this time;

[0132] (c) according to the initial pressure value P1, the initial temperature value T1, the second pressure value P2 and the second temperature value T2, calculate the pressure-temperature function relationship;

[0133] (d) based on the pressure-temperature function relationship, calculate the first pressure threshold P3 and the second pressure threshold P4 under the preset target temperature, wherein P4 is greater than P3;

[0134] (e) control the heating element to rise to the preset target temperature, and monitor the current pressure value P in real time;

[0135] (f) when the current pressure value P reaches the first pressure threshold P3, lowering the target temperature of the heating element to a new target temperature that is lower than the preset target temperature;

[0136] (g) when the current pressure value P exceeds the second pressure threshold P4 and the current temperature is lower than the preset target temperature, controlling the radio frequency generator to stop outputting radio frequency energy;

[0137] a display, electrically connected to the processor, for displaying the pressure value change before and after treatment, reflecting the shrinkage of the cavity tissue.

[0138] Specifically, this embodiment describes a system for intracavitary radiofrequency ablation, the core component of which is a heating element, the structure of which is shown in Figure 1 The main components of the system include a radio frequency generator, a catheter, a pressure sensor, a temperature sensor, a processor, and a display.

[0139] First, the radio frequency generator is responsible for generating and transmitting radio frequency energy to the heating element of the catheter. After receiving the energy, the heating element of the catheter heats the tissue in the cavity to achieve tissue ablation. The catheter is also equipped with a pressure sensor 10 and a temperature sensor, which are used to detect the contact pressure of the heating element and the temperature of the heating element, respectively. Real-time feedback from the pressure sensor and the temperature sensor is an important guarantee for the safety and accuracy of the system.

[0140] Second, the processor, as the core control unit of the system, is connected to the radio frequency generator, the pressure sensor, and the temperature sensor. The working principle of the processor can be found in Figure 2 and Figure 3 It can dynamically adjust the output of radio frequency energy according to the preset control logic. The processor first obtains the initial pressure value P1 and the temperature value T1, then controls the radio frequency generator to output radio frequency energy to the heating element, so that its temperature rises to the second temperature value T2, and records the second pressure value P2 at this time.

[0141] Next, the processor calculates the pressure-temperature function relationship based on the initial pressure value P1, the initial temperature value T1, the second pressure value P2, and the second temperature value T2. This function relationship is used to further calculate the first pressure threshold P3 and the second pressure threshold P4 at the preset target temperature, where P4 is greater than P3. Based on these calculations, the processor can accurately control the working state of the heating element.

[0142] During the treatment, the processor controls the heating element to heat up to a preset target temperature and monitors the current contact pressure value P in real time. When the current pressure value reaches a first pressure threshold P3, in order to prevent excessive heating, the processor will lower the target temperature of the heating element to a new target temperature lower than the preset target temperature. If the current pressure value exceeds a second pressure threshold P4 and the current temperature is lower than the preset target temperature, the processor will stop the output of radio frequency energy to ensure the safety of the treatment.

[0143] In addition, the display is electrically connected with the processor and is responsible for showing the user the changes in pressure value during the treatment. Through the display, the operator can intuitively understand the contraction of the cavity tissue, thereby providing real-time feedback and helping to improve the accuracy and effectiveness of the treatment.

[0144] This embodiment ensures the safety and tissue protection during radiofrequency ablation through the dual monitoring mechanism of temperature and pressure. At the same time, by adjusting the heating element temperature and the output of radio frequency energy in real time, tissue damage caused by overheating is avoided, and the accuracy and reliability of the entire treatment process are improved.

[0145] Optionally, the processor is further configured to:

[0146] According to the initial pressure value P1, the initial temperature value T1, the second pressure value P2 and the second temperature value T2, the pressure value P at the current temperature T is calculated using a pressure-temperature function relationship, and the pressure-temperature function relationship is:

[0147] P = [(P2-P1) / (T2-T1)]xT + [(P1xT2-P2xT1) / (T2-T1)]+a

[0148] wherein,

[0149] P is the current pressure value, i.e. the pressure value calculated at the current temperature T.

[0150] P1 is the initial pressure value, i.e. the pressure value measured at the initial temperature T1.

[0151] P2 is the second pressure value, i.e. the pressure value measured when the temperature rises to T2.

[0152] T1 is the initial temperature value.

[0153] T2 is the second temperature value, higher than T1.

[0154] T is the current temperature, used to calculate the current pressure value.

[0155] [(P2-P1) / (T2-T1)] represents the rate of change of pressure with temperature, i.e. the slope of the change of pressure with temperature.

[0156] [(P1 x T2 - P2 x T1) / (T2 - T1)] is the intercept term of the linear equation.

[0157] a is a correction constant used to adjust the deviation between the theoretical calculation and the actual measurement.

[0158] Specifically, this optional implementation further expands the functions of the processor by calculating the pressure value P at the current temperature T through a pressure-temperature function. This calculation process is based on the measurement of the initial and second temperature and pressure values, aiming to achieve more accurate control and dynamic adjustment of the system state.

[0159] Specifically, the processor first obtains the initial pressure value P1 and the initial temperature value T1, then controls the radio frequency generator to raise the temperature of the heating element, and records the second pressure value P2 when the temperature reaches the second temperature value T2. Through the temperature and pressure data at these initial and second states, the processor can establish a function relationship between pressure and temperature for predicting the pressure value PP at the current temperature T.

[0160] In the above formula, a is a correction constant used to fine-tune the deviation between the theoretical calculation and the actual measurement, ensuring that the formula is closer to the actual situation. Its existence allows the system to flexibly adjust the calculation result of the pressure according to different operating environments and patient characteristics.

[0161] By calculating the pressure value at the current temperature, the system can accurately monitor the contact between the catheter and the tissue during the treatment process. This dynamic monitoring process can effectively prevent the occurrence of overheating or overpressure, ensuring the safety of the radiofrequency ablation process. In addition, using this pressure-temperature function, the system can automatically adjust the output power or temperature of the heating element according to real-time feedback, thereby optimizing the treatment effect and reducing damage to normal tissue.

[0162] This implementation clearly expresses the relationship between pressure and temperature through a mathematical model, not only improving the control accuracy of the system, but also providing a theoretical basis for the adaptive adjustment of the system.

[0163] Optionally, the processor is further configured to:

[0164] In step (d), the second pressure threshold P4 is calculated according to the formula P4 = P3 x K, where,

[0165] P4 is the second pressure threshold, representing the upper limit of the pressure at which the system stops outputting radiofrequency energy.

[0166] P3 is the first pressure threshold, representing the pressure value at which the system begins to reduce the target temperature.

[0167] K is a preset constant with a value greater than 1, used to determine the multiple relationship of the second pressure threshold relative to the first pressure threshold.

[0168] P4>P3, ensuring that when the pressure continues to rise, the system has a buffer interval to adjust the treatment parameters, and stops the treatment in time if necessary.

[0169] Specifically, in this optional embodiment, the processor is further configured to calculate the second pressure threshold P4 by the formula. The core of this function is to dynamically adjust the behavior of the system according to the change of pressure, to ensure the safety and accuracy of the treatment process.

[0170] In the above formula, P4 represents the second pressure threshold, i.e. the upper limit of the pressure at which the system stops the output of radio frequency energy during treatment. When the pressure value reaches or exceeds this upper limit, the system will immediately stop energy transmission to prevent excessive pressure on the tissue and avoid damage. P3 represents the first pressure threshold, when the current pressure value reaches P3, the system starts to reduce the target temperature of the heating element. This threshold is used to prevent the pressure from rising further, and at the same time as a warning mechanism to indicate that the pressure has entered a range that needs to be adjusted.

[0171] K is a preset constant, and K>1K>1. It is used to determine the multiple relationship of the second pressure threshold P4 relative to the first pressure threshold P3. By introducing this constant, the system can flexibly set the value of P4, so that it is higher than P3, thereby providing sufficient buffer space for the system to cope with pressure fluctuations during treatment.

[0172] The goal of this embodiment is to establish a hierarchical pressure control mechanism. First, when the pressure reaches the first threshold P3, the system does not immediately stop the energy output, but reduces the target temperature of the heating element to alleviate the rising trend of the pressure. This preventive mechanism allows the system to continue working within a moderate pressure range, while avoiding excessive temperature rise.

[0173] However, if the pressure continues to rise and reaches the second pressure threshold P4, the system will immediately stop the output of radio frequency energy. This action is to provide the last line of defense when the pressure is too large, to prevent irreversible damage to the patient's tissue during treatment.

[0174] The reason for introducing the coefficient K is that it provides flexibility and adjustability to the system. The tissue characteristics of different patients may be different, and the rate of pressure change during treatment may also vary. By adjusting the value of K, the system can set appropriate second pressure thresholds according to the specific treatment needs, thereby avoiding premature or late stopping of the output of radio frequency energy.

[0175] P4>P3, the system has a buffer zone when the pressure keeps rising. When the pressure reaches P3, the system has enough time to adjust by lowering the temperature. When the adjustment fails or the pressure continues to rise to P4, the system will stop the RF energy output decisively. This tiered response mechanism significantly improves the safety of the system, ensuring that even under more complex treatment conditions, the system can effectively prevent tissue overheating or overpressure.

[0176] Through this mechanism, the RF ablation system can achieve a higher level of intelligent control during treatment, both ensuring the effectiveness of treatment and minimizing damage to normal tissue.

[0177] Optionally, the processor is further configured to:

[0178] In step (f), the new target temperature Tp is calculated according to the formula Tp = b x Ts, where Ts is the preset target temperature and b is a preset coefficient greater than 0 and less than 1.

[0179] Specifically, in this optional embodiment, the processor is further configured to calculate the new target temperature Tp by the formula Tp = b x Ts. The purpose of this function is to dynamically adjust the target temperature of the heating element according to certain conditions (e.g. the pressure reaching a certain threshold) during treatment, thereby preventing the temperature from being too high during treatment and ensuring the safety of the treatment.

[0180] In the above formula, Tp is the new target temperature. When the system detects that the pressure reaches the first pressure threshold P3, the system will not immediately stop the energy output, but will lower the temperature of the heating element to this new target temperature Tp to slow down the further rise of the pressure. Ts is the preset target temperature. Ts is the temperature value set by the user or the system before the treatment begins, usually the highest temperature to be reached during the treatment. B is a preset coefficient, and 0 < b < 1. B controls the amplitude of the temperature drop, indicating the percentage of the new target temperature relative to the preset target temperature. Since the value of b is between 0 and 1, using this coefficient can ensure that the new target temperature Tp is always lower than the preset target temperature Ts.

[0181] The core purpose of the above optional embodiment is to provide a dynamic temperature adjustment mechanism. When the pressure reaches or approaches the first pressure threshold P3 during treatment, directly stopping the RF energy output may affect the treatment effect. Therefore, the system chooses to alleviate the rising trend of the pressure by lowering the temperature of the heating element. This gradual adjustment allows the system to solve the problem of excessive pressure by lowering the temperature without completely interrupting the treatment.

[0182] Through the formula Tp = b x Ts, the processor can flexibly calculate an appropriate temperature drop value:

[0183] When b is close to 1, the temperature decrease is small, and the system selects a higher new target temperature, which is suitable for cases where a small temperature adjustment is needed.

[0184] When b is small (close to 0), the new target temperature decreases more, which is suitable for cases where a large temperature decrease is needed.

[0185] The value of b in this formula can be adjusted according to specific treatment needs. For example, the system can select different b values for different patient tissue characteristics or different treatment stages in order to optimize treatment effectiveness.

[0186] Through the mechanism of reducing the target temperature, the system can effectively prevent tissue damage caused by excessive temperature. Especially during the treatment process, when the pressure rises, directly reducing the temperature of the heating element can quickly reduce the heat transmitted to the tissue, thereby avoiding excessive contraction or burning of the tissue.

[0187] In addition, since the range of b is limited between 0 and 1, the new target temperature Tp is always less than the preset target temperature Ts, which provides an additional safety guarantee for the system. Even in extreme cases, the system will not maintain the temperature at a high-risk level.

[0188] By using the formula Tp = b × Ts, the system can flexibly adjust the temperature according to real-time pressure feedback, ensuring optimal treatment effectiveness under different treatment conditions. This automated temperature adjustment enables the system to have higher adaptive ability when facing complex treatment environments.

[0189] In addition, the processor can adjust the range of b values according to different surgical scenarios or patient needs. For example, in some cases, the doctor may want the temperature to decrease only slightly, in which case a larger b value can be selected. In other cases, such as when the risk of tissue overheating is high, a smaller b value can be selected to reduce the temperature more significantly.

[0190] This embodiment introduces the b coefficient and the formula Tp = b × Ts to provide a dynamic temperature adjustment mechanism for radiofrequency ablation systems based on pressure feedback. It not only improves safety during treatment, but also ensures that the system can adapt to different treatment situations through a flexible temperature adjustment mechanism, thereby optimizing the final treatment effectiveness.

[0191] Optionally, the processor is further configured to:

[0192] In step (f), after reducing the target temperature of the heating element to the new target temperature, the heating element is controlled to maintain the new target temperature until the preset treatment time ends; wherein,

[0193] The processor is further configured to continuously monitor the current pressure value P during the maintaining of the new target temperature, and perform step (g) when the current pressure value P exceeds the second pressure threshold P4.

[0194] Optionally, the processor is further configured to:

[0195] In step (g), when controlling the radio frequency generator to stop outputting radio frequency energy, the following operations are simultaneously performed:

[0196] (i) displaying abnormal warning information on the display, the abnormal warning information including a prompt that the current pressure value P exceeds the second pressure threshold P4;

[0197] (ii) generating an audible alarm sound; and

[0198] (iii) recording the time of abnormality occurrence, the current pressure value P and the current temperature value into a system log.

[0199] Optionally, the system further comprises:

[0200] a user input interface electrically connected to the processor, the user input interface being configured to:

[0201] (i) receive a preset target temperature Ts input by a user;

[0202] (ii) receive a preset treatment time input by a user;

[0203] (iii) receive a coefficient b input by a user, where 0 < b < 1, for calculating the new target temperature Tp;

[0204] (iv) receive a constant K input by a user, where K > 1, for calculating the second pressure threshold P4;

[0205] wherein the processor is further configured to perform steps (a) to (g) in claim 1 according to the parameters received from the user input interface, and use these parameters for corresponding calculations and controls during the execution.

[0206] Optionally, the display is configured to:

[0207] display the following information in real time:

[0208] (i) the current pressure value P;

[0209] (ii) the current temperature value T;

[0210] (iii) the target temperature value, including the preset target temperature Ts and the new target temperature Tp (if applicable);

[0211] (iv) the remaining treatment time;

[0212] (v) a first pressure threshold P3 and a second pressure threshold P4;

[0213] (vi) an output power of the radio frequency generator;

[0214] (vii) a system running status, including normal running, cooling down phase, or abnormal stop, etc.

[0215] Optionally, the heating element comprises:

[0216] (i) a thermocouple 20 for measuring the temperature of the heating element in real time and transmitting the measurement results to the processor;

[0217] (ii) a heating element winding coaxially surrounding the thermocouple 20, the heating element winding 30 being configured to receive radio frequency energy from the radio frequency generator, convert it into heat and distribute it uniformly;

[0218] (iii) an insulation layer covering the outside of the heating element winding 30 for electrical insulation and heat retention;

[0219] (iv) a flexible shell made of biocompatible material covering the entire heating element structure.

[0220] Optionally, the system further comprises: a swelling liquid injection device electrically connected to the processor, the swelling liquid injection device being configured to:

[0221] (i) inject a preset volume of swelling liquid into the cavity tissue;

[0222] (ii) send an injection completion signal to the processor;

[0223] wherein the processor is further configured to:

[0224] (a) receive the injection completion signal;

[0225] (b) in response to the injection completion signal, continuously monitor the contact between the heating element and the cavity tissue through the pressure sensor 10;

[0226] (c) based on the measurement results of the pressure sensor 10, calculate the contact area percentage of the heating element and the cavity tissue;

[0227] (d) control the display to display the contact in real time, including: numerical display of the contact area percentage, and / or graphical representation of the contact state;

[0228] (e) when the contact area percentage is lower than a preset threshold, control the display to issue a warning signal.

[0229] Optionally, the processor is further configured to dynamically adjust the radio frequency energy output power, specifically comprising:

[0230] (a) setting an initial radio frequency output power value Pinitial;

[0231] (b) continuously acquiring a current temperature value T and a current pressure value P at a preset sampling frequency during the treatment process;

[0232] (c) calculating a power adjustment factor a based on the current temperature value T, the current pressure value P, a target temperature Ts and a first pressure threshold P3, wherein:

[0233] a = f(T, P, Ts, P3), f being a preset power adjustment function;

[0234] (d) calculating a new radio frequency output power value Pnew according to the power adjustment factor a:

[0235] Pnew = Pcurrent x a

[0236] wherein Pcurrent is the current radio frequency output power value;

[0237] (e) applying the new radio frequency output power value Pnew to the radio frequency generator to dynamically adjust the radio frequency energy output;

[0238] (f) setting an upper limit value Pmax and a lower limit value Pmin for power adjustment, ensuring that:

[0239] Pmin ≤ Pnew ≤ Pmax

[0240] wherein Pmin and Pmax are predefined safe power ranges;

[0241] (g) triggering a rapid power adjustment when any of the following conditions occurs:

[0242] (i) when the temperature rapidly rises and exceeds a preset safe temperature threshold Tsafe, immediately reducing the output power to Pmin;

[0243] (ii) when the pressure rapidly rises and exceeds the first pressure threshold P3, reducing the output power to a preset percentage β% (where 0 < β < 100) of the current power;

[0244] (h) recording the relevant data of power adjustment after each power adjustment, including but not limited to: adjustment time, power before adjustment, power after adjustment, current temperature, current pressure and power adjustment factor a;

[0245] (i) Based on the recorded data, generate power adjustment curves and temperature pressure change curves, and show these curves to the user through the display after the treatment is completed for analysis;

[0246] (j) Based on historical treatment data and machine learning algorithms, periodically optimize the power adjustment function f to improve the system's adaptability and treatment effectiveness.

[0247] Specifically, in the above optional optional implementation, the processor is configured to dynamically adjust the output power of the radio frequency energy to adapt to the changes in temperature and pressure during treatment, thereby ensuring the effectiveness and safety of the treatment. This process is achieved through a series of carefully designed steps, each with its specific purpose and function.

[0248] First, the system sets an initial radio frequency output power value as the baseline at the beginning of treatment. During treatment, the system continuously monitors the current temperature and pressure values at a predetermined frequency, and these real-time data are the basis for subsequent dynamic adjustments. Based on these data, the system calculates a power adjustment factor that takes into account the current temperature, pressure, target temperature, and preset pressure threshold.

[0249] Next, the system uses this adjustment factor to calculate a new radio frequency output power. This calculation method allows the system to optimize power in real time based on the current treatment status. To ensure safety, the system also sets upper and lower limits for power adjustment, ensuring that the new power value is always within the predefined safety range.

[0250] In addition, the system also contains a rapid power adjustment mechanism. When the temperature or pressure rises rapidly and exceeds the preset threshold, the system immediately reduces the output power to prevent overheating or overpressure from causing damage to the tissue. This rapid response mechanism is a key factor in ensuring treatment safety.

[0251] After each power adjustment, the system records detailed data, including adjustment time, power values before and after adjustment, current temperature and pressure, etc. These data are not only used to generate power adjustment curves and temperature pressure change curves for doctors to analyze after treatment, but also provide valuable information for the continuous optimization of the system.

[0252] Finally, the system introduces machine learning algorithms to periodically optimize the power adjustment function using historical treatment data. This self-learning and optimization mechanism can continuously improve the system's adaptability, enabling it to more accurately control radio frequency energy output in future treatments.

[0253] Overall, this dynamic power adjustment mechanism combines real-time data analysis, safety measures, and machine learning techniques, ensuring the safety of the treatment process while continuously optimizing the effectiveness and efficiency of radiofrequency ablation therapy. This intelligent power control method represents the trend of medical devices towards more precise, safer, and more personalized development.

[0254] The above embodiments have the following technical effects:

[0255] Precise control of radiofrequency energy output to avoid tissue damage: By monitoring temperature and pressure in real time and dynamically adjusting radiofrequency energy output power, the system can quickly respond to changes in tissue contact pressure, prevent excessive energy transmission, and avoid tissue burns caused by excessive heating. Especially in the case of rapid temperature rise or pressure exceeding the threshold, the system can immediately reduce the output power to ensure the safety and accuracy of the treatment.

[0256] Real-time feedback of cavity tissue contraction to improve treatment effectiveness: The system obtains the contact pressure between the catheter and the cavity tissue through the pressure sensor and displays the contraction of the cavity tissue before and after treatment on the display. This real-time feedback not only helps doctors better understand the treatment process, but also allows them to take timely measures when the cavity tissue contracts abnormally, reducing the risk of surgery.

[0257] Automatic adjustment of treatment temperature to avoid excessive heat: The system automatically calculates and adjusts the treatment temperature based on the pressure changes at different temperature points. When the pressure reaches the set threshold, the system will lower the target temperature and maintain an appropriate temperature level according to the treatment time to avoid excessive heating and reduce damage to normal tissues.

[0258] Abnormal detection and alarm function to improve operational safety: When abnormal conditions occur during treatment (such as pressure or temperature exceeding the set threshold), the system can stop radiofrequency energy output in time and issue an abnormal warning through the display and alarm to prompt the doctor to take appropriate measures. This mechanism greatly improves the operational safety of the system and reduces medical accidents caused by equipment failure or operational errors.

[0259] Efficient data recording and analysis to optimize treatment plans: The system records temperature, pressure, power changes and other data during each treatment and generates related curves for user analysis. Through these data, doctors can more accurately evaluate the treatment effect and optimize subsequent treatment plans based on historical data. In addition, the system can combine machine learning algorithms to automatically optimize the power adjustment function, further improving the adaptive ability and effectiveness of treatment.

[0260] A flexible power adjustment mechanism adapts to different clinical needs: The system sets upper and lower limits for power adjustment and dynamically adjusts the radiofrequency output power through a power adjustment factor. This flexible power adjustment mechanism enables the system to adapt to different treatment environments and individual patient differences, ensuring that the energy output during treatment remains within a safe and effective range.

[0261] Reducing manual intervention by doctors and improving surgical efficiency: Through automated temperature and pressure monitoring, power adjustment, and anomaly handling, the system reduces manual intervention by doctors and displays key treatment-related data in real time, helping doctors complete surgeries more efficiently. This not only improves surgical efficiency but also reduces errors caused by human intervention.

[0262] In summary, this application significantly improves the safety, accuracy, and efficiency of radiofrequency ablation treatment, providing a more reliable treatment tool for clinical practice.

[0263] It should be noted that in this patent application, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one" does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element. In this patent application, if it refers to performing an action according to an element, it means performing the action at least according to that element, including two cases: performing the action only according to that element, and performing the action according to that element and other elements. Expressions such as "multiple," "repeatedly," and "various" include two, two times, two kinds, and more than two, more than two times, and more than two kinds.

[0264] All documents mentioned in this application are considered to be incorporated in their entirety into the disclosure of this application so that they can serve as a basis for modifications if necessary. Furthermore, it should be understood that after reading the foregoing disclosure of this application, those skilled in the art can make various alterations or modifications to this application, and these equivalent forms also fall within the scope of protection claimed in this application.

Claims

1. An intracavitary radiofrequency ablation system, characterized in that, The system includes: Radio frequency generator, a heating element used to generate radio frequency energy and transmit it to the conduit; The catheter includes: a heating element for receiving radio frequency energy and heating the cavity tissue; a pressure sensor disposed at the heating element for detecting the contact pressure between the heating element and the cavity tissue; and a temperature sensor disposed at the heating element for detecting the temperature of the heating element. A processor, electrically connected to the radio frequency generator, pressure sensor, and temperature sensor, is configured to: (a) Obtain the initial pressure value P1 and the initial temperature value T1; (b) Control the radio frequency generator to output radio frequency energy to the heating element, raising its temperature to the second temperature value T2, and obtain the second pressure value P2 at this time; (c) Calculate the pressure-temperature function relationship based on the initial pressure value P1, the initial temperature value T1, the second pressure value P2, and the second temperature value T2; (d) Calculate the first pressure threshold P3 and the second pressure threshold P4 at the preset target temperature based on the pressure-temperature function relationship, where P4 is greater than P3; (e) Control the heating element to heat up to the preset target temperature, and monitor the current pressure value P in real time; (f) When the current pressure value P reaches the first pressure threshold P3, reduce the target temperature of the heating element to a new target temperature lower than the preset target temperature, and then control the heating element to maintain the new target temperature until the preset treatment time ends; (g) Continuously monitor the current pressure value P while maintaining the new target temperature, and when the current pressure value P exceeds the second pressure threshold P4 and the current temperature is lower than the preset target temperature, control the radio frequency generator to stop outputting radio frequency energy; The display, electrically connected to the processor, is used to show changes in pressure values ​​before and after treatment, reflecting the contraction of the cavity tissues.

2. The intracavitary radiofrequency ablation system according to claim 1, characterized in that, The processor is further configured to: Based on the initial pressure value P1, the initial temperature value T1, the second pressure value P2, and the second temperature value T2, the pressure value P at the current temperature T is calculated using the pressure-temperature function relationship, which is: P=[(P2-P1) / (T2-T1)]×T+[(P1×T2-P2×T1) / (T2-T1)]+a Where a is a correction constant and T is the current temperature.

3. The intracavitary radiofrequency ablation system according to claim 1, characterized in that, The processor is further configured to: In step (d), the second pressure threshold P4 is calculated according to the formula P4 = P3 × K, where K is a preset constant greater than 1.

4. The intracavitary radiofrequency ablation system according to claim 1, characterized in that, The processor is further configured to: In step (f), the new target temperature Tp is calculated according to the formula Tp = b × Ts, where Ts is the preset target temperature and b is a preset coefficient greater than 0 and less than 1.

5. The intracavitary radiofrequency ablation system according to claim 1, characterized in that, The processor is further configured to: In step (g), when the radio frequency generator is controlled to stop outputting radio frequency energy, the following operations are performed simultaneously: (i) Displaying abnormal warning information on the display, the abnormal warning information including a prompt that the current pressure value P exceeds the second pressure threshold P4; (ii) Generate an audible alarm sound; And (iii) Record the time of the occurrence of the abnormality, the current pressure value P, and the current temperature value in the system log.

6. The intracavitary radiofrequency ablation system according to claim 1, characterized in that, The system further includes: A user input interface, electrically connected to the processor, the user input interface being configured to: (i) Receive a preset target temperature Ts input by the user; (ii) Receive a preset treatment time input by the user; (iii) Receive a coefficient b input by the user, where 0 < b < 1, for calculating a new target temperature Tp; (iv) Receive a constant K input by the user, where K > 1, for calculating a second pressure threshold P4; Wherein, the processor is further configured to perform steps (a) to (g) in claim 1 according to the parameters received from the user input interface, and use these parameters for corresponding calculations and controls during the execution process.

7. The intracavitary radiofrequency ablation system according to claim 1, characterized in that, The display is configured to: Real-time display the following information: (i) The current pressure value P; (ii) The current temperature value T; (iii) The target temperature value, including the preset target temperature Ts and the new target temperature Tp (if applicable); (iv) The remaining treatment time; (v) The first pressure threshold P3 and the second pressure threshold P4; (vi) The output power of the radio frequency generator; (vii) The system operation status, including normal operation, cooling phase, or abnormal stop.

8. The intracavitary radiofrequency ablation system according to claim 1, characterized in that, The heating element includes: (i) A thermocouple for real-time measuring the temperature of the heating element and transmitting the measurement result to the processor; (ii) A heating element winding coaxially surrounding the thermocouple, the heating element winding being configured to receive radio frequency energy from the radio frequency generator, convert it into heat, and distribute it evenly; (iii) An insulating layer covering the outside of the heating element winding for electrical insulation and heat retention; (iv) A flexible housing made of a biocompatible material covering the entire heating element structure.

9. The intracavitary radiofrequency ablation system according to claim 1, characterized in that, The system further includes: A swelling liquid injection device, electrically connected to the processor, the swelling liquid injection device being configured to: (i) Inject a preset volume of swelling liquid into the cavity tissue; (ii) Send an injection completion signal to the processor; Wherein, the processor is further configured to: (a) Receive the injection completion signal; (b) In response to the injection completion signal, continuously monitor the contact situation between the heating element and the cavity tissue through the pressure sensor; (c) Calculate the contact area percentage between the heating element and the cavity tissue based on the measurement result of the pressure sensor; (d) Control the display to real-time display the contact situation, including: numerical display of the contact area percentage, and / or graphical representation of the contact state; (e) When the contact area percentage is lower than a preset threshold, control the display to emit a warning signal.

10. The intracavitary radiofrequency ablation system according to claim 1, characterized in that, The processor is further configured to dynamically adjust the radio frequency energy output power, specifically including: (a) Set an initial radio frequency output power value Pinitial; (b) During the treatment process, continuously obtain the current temperature value T and the current pressure value P at a preset sampling frequency; (c) Calculate the power adjustment factor α based on the current temperature T, the current pressure P, the target temperature Ts, and the first pressure threshold P3, where: α = f(T, P, Ts, P3), where f is a preset power adjustment function; (d) Calculate the new RF output power value Pnew based on the power adjustment factor α: Pnew = Pcurrent × α Where Pcurrent is the current RF output power value; (e) Apply the new RF output power value Pnew to the RF generator to dynamically adjust the RF energy output; (f) Set the upper limit value Pmax and the lower limit value Pmin for power adjustment to ensure: Pmin≤Pnew≤Pmax Wherein, Pmin and Pmax are predefined safe power ranges; (g) Fast power adjustment is triggered when any of the following conditions occur: (i) When the temperature rises rapidly and exceeds the preset safe temperature threshold Tsafe, the output power is immediately reduced to Pmin; (ii) When the pressure rises rapidly and exceeds the first pressure threshold P3, the output power is reduced to a preset percentage β% of the current power (where 0 < β < 100); (h) After each power adjustment, record the relevant data of the power adjustment, including but not limited to: adjustment time, power before adjustment, power after adjustment, current temperature, current pressure and power adjustment factor α; (i) Based on the recorded data, generate power adjustment curves and temperature and pressure change curves, and display these curves to the user via the display after treatment for analysis; (j) Based on historical treatment data and machine learning algorithms, the power adjustment function f is periodically optimized to improve the system's adaptability and treatment effect.

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