Biocavity ablation system, biocavity ablation method and storage medium

Abstract

This invention provides a biocavity ablation system, a biocavity ablation method, and a storage medium. The biocavity ablation system includes an energy module, a delivery module, and a control module. The energy module generates ablation energy to the target area of ​​the biocavity. The delivery module transmits the ablation energy to the target area and monitors the temperature of the target area in real time. The control module monitors the parameter values ​​corresponding to the ablation energy generated by the energy module in real time and adjusts the ablation energy of the energy module in real time based on the parameter values ​​and the temperature of the target area. With this configuration, this invention uses the detected parameter values ​​of the ablation energy and the temperature of the target area to provide feedback and control of the ablation energy during ablation treatment, achieving a biological monitoring and feedback function. This improves the safety factor of the ablation energy output process, thereby avoiding excessively high actual temperatures in the target area, ensuring safe and gentle ablation treatment, and reducing the probability of postoperative complications for patients.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a biological cavity ablation system, a biological cavity ablation method, and a storage medium. Background Technology

[0002] Rhinitis, or inflammation and swelling of the nasal mucosa, causes symptoms such as runny nose, itchy nose, and nasal congestion. Chronic and allergic rhinitis affects tens of millions of patients annually in China alone and is one of the most common reasons for seeking medical attention. Generally, rhinitis is treated with medication-containing medical devices, such as nasal sprays and allergy injections. Unfortunately, the effects of these medications are temporary and can cause various side effects.

[0003] Another approach to treating rhinitis is through surgery. Surgical options are limited and invasive, typically involving the removal of nasal tissue. Turbinate repositioning is one surgical method for treating chronic or allergic rhinitis; however, this procedure is relatively invasive, usually has only temporary effects, and can lead to complications such as mucosal shedding, acute pain and swelling, and bone damage. Another treatment for chronic rhinitis is endoscopic pterygopalatine ganglion resection. While this method is very effective in treating chronic rhinitis, it has been largely abandoned, primarily because the autonomic fibers in the pterygopalatine ganglion innervate the lacrimal glands, and complications associated with this treatment include dry eye.

[0004] In view of this, it is necessary to propose a non-invasive radiofrequency ablation system for rhinitis to greatly reduce the chance of complications for patients after radiofrequency surgery. Summary of the Invention

[0005] This invention provides a biocavitary ablation system, a biocavitary ablation method, and a storage medium, which aim to safely output ablation energy during the operation to avoid excessively high actual temperature in the target area and reduce the probability of complications after rhinitis ablation surgery.

[0006] To address the aforementioned technical problems, based on a first aspect of the present invention, the present invention provides a biological cavity ablation system, comprising:

[0007] An energy module, used to generate ablation energy to the target area in the biological cavity;

[0008] A delivery module is used to transmit the ablation energy to the target area of ​​the biocavitary cavity and to detect the temperature of the target area in real time.

[0009] The control module is used to detect in real time the parameter values ​​corresponding to the ablation energy generated by the energy module. The parameter values ​​include current values ​​and / or voltage values. Both the delivery module and the energy module are connected to the control module. The control module adjusts the ablation energy of the energy module in real time according to the parameter values ​​and the temperature value of the target area fed back by the delivery module.

[0010] Optionally, the energy module includes:

[0011] Signal generating unit, which is used to generate ablation electrical signals;

[0012] A signal filtering unit is used to perform low-pass filtering on the ablation electrical signal at a preset frequency.

[0013] A power amplification unit is used to amplify the ablation electrical signal processed by the signal filtering unit by a preset factor to obtain the ablation energy.

[0014] Optionally, the delivery module includes a catheter and an ablation head. The proximal module of the catheter is connected to the energy module, and the ablation head is disposed at the distal end of the catheter. The ablation head is used to transmit the ablation energy to the target area of ​​the biological cavity, and the ablation head is used to detect the temperature of the target area.

[0015] Optionally, the catheter has a curved section connected to the ablation head, the curved section being offset relative to the axis of the catheter.

[0016] Optionally, the ablation head includes:

[0017] A substrate connected to the conduit, the substrate having a reference surface;

[0018] Multiple ablation electrodes are mounted on the substrate at intervals and are all located on the reference plane. The ablation electrodes are electrically connected to the energy module.

[0019] A temperature detection unit is mounted on the substrate and located on the reference surface. The temperature detection unit is communicatively connected to the control module.

[0020] Optionally, the ablation head includes at least two sets of electrode rows arranged side by side at intervals, each set of electrode rows including a plurality of ablation electrodes arranged collinearly, and the temperature detection unit is located between two adjacent sets of electrode rows.

[0021] Optionally, the control module controls the energy module to stop generating the ablation energy according to preset conditions, and generates an alarm signal according to the preset conditions; the preset conditions are configured as follows: the current value of the ablation energy is greater than a current threshold, and / or, the temperature of the target area is greater than a temperature threshold.

[0022] Optionally, the biocavity ablation system further includes a human-computer interaction module, which includes a touch component and / or a visualization component; the touch component is connected to the control module, and the touch component is triggered to drive the control module to adjust the working state of the energy module; the visualization component includes an endoscope and a display, the endoscope is used to extend into the biocavity to acquire endoscopic images of the target area, and the display is used to visualize the endoscopic images.

[0023] Optionally, the control module is configured to execute:

[0024] Obtain the ablation energy at sampling time t m To t m+n The current values ​​corresponding to each sampling time in the data;

[0025] Calculate the sampling time t respectively m+1 To t m+n The current values ​​corresponding to each sampling time and the sampling time t m The difference between the corresponding current values ​​yields (n-1) different deviation values;

[0026] The current increment is obtained based on (n-1) different deviation values, and the current increment is based on the sampling time t. m+n The current value is obtained at sampling time t m+n+1 The corresponding current value;

[0027] Based on sampling time t m+n+1 The corresponding current value outputs a PWM signal with a corresponding duty cycle, and the energy module is controlled to output the ablation energy according to the PWM signal;

[0028] Where n is greater than or equal to 3, m is greater than or equal to 0, and m and n are both integers.

[0029] Optionally, when n equals 3, the current increment is equal to the sampling time t. m+2 The corresponding deviation value and sampling time t m+1 The difference between the corresponding deviation values;

[0030] When n is greater than 3, the current increment is equal to the average of (n-1) different deviation values.

[0031] Optionally, the biological cavity ablation system includes a signal routing circuit module connected to both the energy module and the delivery module. The signal routing circuit module divides the ablation energy into at least two signals, one of which is directed to the control module to detect the parameter value of the ablation energy, and the other signal is directed to the delivery module to transmit the ablation energy to the target area.

[0032] Based on a second aspect of the present invention, the present invention also provides a method for ablation of biological cavities, comprising:

[0033] Deliver ablation energy to the target region within the biological cavity;

[0034] The parameter values ​​corresponding to the ablation energy generated are detected in real time, and the temperature value of the target area is detected in real time. The parameter values ​​include voltage values ​​and / or current values.

[0035] The ablation energy is adjusted in real time based on the parameter values ​​and the temperature of the target area.

[0036] Optionally, the step of adjusting the ablation energy according to the parameter value includes:

[0037] The ablation energy is obtained at sampling time t. m To t m+n The current values ​​corresponding to each sampling time in the data;

[0038] Calculate the sampling time t respectively m+1 To t m+n The current values ​​corresponding to each sampling time and the sampling time t m The difference between the corresponding current values ​​yields (n-1) different deviation values;

[0039] The current increment is obtained based on (n-1) different deviation values, and the current increment is based on the sampling time t. m+n The corresponding current value is obtained at sampling time t. m+n+1 The corresponding current value;

[0040] Based on sampling time t m+n+1 The corresponding current value outputs a PWM signal with a corresponding duty cycle, and the energy module is controlled to output the ablation energy according to the PWM signal;

[0041] Where n is greater than or equal to 3, m is greater than or equal to 0, and m and n are both integers.

[0042] Based on a third aspect of the invention, the invention also provides a storage medium having a readable and writable program stored thereon, which, when executed, implements the biological cavity ablation method as described above.

[0043] In summary, the biocavity ablation system, biocavity ablation method, and storage medium provided by this invention include an energy module, a delivery module, and a control module. The energy module generates ablation energy to the target area of ​​the biocavity. The delivery module transmits the ablation energy to the target area of ​​the biocavity and monitors the temperature of the target area in real time. The control module monitors the parameter values ​​corresponding to the ablation energy generated by the energy module in real time. The parameter values ​​include voltage and / or current values. Both the delivery module and the energy module are connected to the control module. The control module adjusts the ablation energy of the energy module in real time based on the parameter values ​​and the temperature value of the target area fed back by the delivery module.

[0044] With this configuration, the present invention uses the detected voltage and / or current values ​​of the ablation energy, along with the temperature of the target area, to provide feedback and regulate the ablation energy during the ablation treatment process. This serves as a bio-monitoring feedback function, improving the safety of the ablation energy output process, preventing excessively high temperatures in the target area, ensuring ablation treatment is performed safely and gently, and reducing the likelihood of postoperative complications. Furthermore, the delivery module extends into the bio-cavity and adheres to the target area to transmit ablation energy without penetrating the tissue within the bio-cavity. This ensures that the invented bio-cavity ablation system is a non-invasive treatment method, precisely delivering ablation energy to the nerve-dense areas of the target region while minimizing damage to surrounding tissues, improving patient comfort, enhancing the ablation treatment effect, and reducing postoperative recovery time. Attached Figure Description

[0045] Those skilled in the art will understand that the accompanying drawings are provided to better understand the invention and do not constitute any limitation on the scope of the invention. Wherein:

[0046] Figure 1 This is a schematic diagram of a biological cavity ablation system according to an embodiment of the present invention;

[0047] Figure 2 This is another schematic diagram of a biological cavity ablation system according to an embodiment of the present invention;

[0048] Figure 3 This is a schematic diagram of the target region of a biocavity according to an embodiment of the present invention;

[0049] Figure 4 This is a schematic diagram of a conveying module according to an embodiment of the present invention;

[0050] Figure 5 This is a schematic diagram of an ablation head according to an embodiment of the present invention;

[0051] Figure 6 This is a flowchart of the biocavity ablation system according to an embodiment of the present invention.

[0052] Figure 7 This is a self-test flowchart of a biological cavity ablation system according to an embodiment of the present invention.

[0053] In the attached image:

[0054] 10-Energy module; 11-Signal generation unit; 12-Signal filtering unit; 13-Power amplification unit;

[0055] 20-Delivery module; 21-Conduit; 210-Bent section; 22-Ablation head; 221-Substrate; 2210-Reference surface; 222-Ablation electrode; 223-Temperature detection unit; 23-Handle;

[0056] 30 - Control module; 31 - Microcontroller; 32 - Temperature controller;

[0057] 40 - Human-computer interaction module; 41 - Foot pedal; 42 - Button; 43 - Display;

[0058] 50 - Target area. Detailed Implementation

[0059] To make the objectives, advantages, and features of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to facilitate and clarify the explanation of the embodiments of this invention. Furthermore, the structures shown in the drawings are often part of the actual structures. In particular, different figures may emphasize different aspects and may sometimes use different scales.

[0060] As used in this invention, the singular forms “a,” “an,” and “the” include plural objects; the term “or” is generally used to mean “and / or”; the term “a number” is generally used to mean “at least one”; and the term “at least two” is generally used to mean “two or more”. Furthermore, the terms “first,” “second,” and “third” are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined with “first,” “second,” or “third” may explicitly or implicitly include one or at least two of that feature. “One module” and “another module,” as well as “near module” and “far module,” generally refer to two corresponding parts, including not only module points. The terms “installed,” “connected,” and “joined” should be interpreted broadly; for example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal connection of two elements or the interaction between two elements. Furthermore, as used in this invention, the phrase "one element is disposed on another element" generally only indicates that there is a connection, coupling, cooperation, or transmission relationship between the two elements, and the connection, coupling, cooperation, or transmission between the two elements can be direct or indirect through an intermediate element. It should not be construed as indicating or implying a spatial positional relationship between the two elements, i.e., one element can be located arbitrarily inside, outside, above, below, or to one side of the other element, unless otherwise explicitly stated. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0061] It should be noted that in the medical field, the definitions of "proximal" and "distal" are as follows: "proximal" usually refers to the end of the medical device that is closest to the operator during normal operation, while "distal" usually refers to the end of the medical device that first enters the patient's body during normal operation.

[0062] Figure 1 This is a schematic diagram of a biological cavity ablation system according to an embodiment of the present invention. Figure 2 This is another schematic diagram of a biocavity ablation system according to an embodiment of the present invention. (See attached diagram.) Figure 1 and Figure 2 An embodiment of the present invention schematically provides a biocavitary ablation system, which includes an energy module 10, a delivery module 20 connected to the energy module 10, and a control module 30 connected to both the energy module 10 and the delivery module 20.

[0063] Description of Energy Module 10: Energy Module 10 generates ablation energy. Control Module 30 controls the output of this ablation energy. The ablation energy is transmitted to the bio-cavity via Delivery Module 20 and can be used to ablate the target area 50 within the bio-cavity. Typically, the control module adjusts the output of the ablation energy based on parameter values ​​corresponding to the generated ablation energy. These parameter values ​​include voltage and / or current values. Bio-cavities include, but are not limited to, the ear cavity, nasal cavity, and throat. Figure 3 This is a schematic diagram of the target region 50 according to an embodiment of the present invention. The biological cavity may be, for example, the nasal cavity, and the target region 50 may be, for example, the area where the posterior nasal parasympathetic nerve is located. The ablation energy includes, but is not limited to, radiofrequency energy, low-temperature plasma, laser, microwave, cryoablation, and focused ultrasound.

[0064] In some other embodiments, the ablation energy can also be microwave energy. When the energy module 10 provides microwave energy, electromagnetic irradiation causes polar molecules in the irradiated tissue to rotate at high speed with the microwave frequency, generating heat through mutual friction. This causes thermal coagulation, necrosis, and sloughing of the tissue in the target area 50, thereby reducing the size of the hypertrophic inferior turbinate and alleviating nasal congestion. Simultaneously, through thermal coagulation of the parasympathetic and sensory nerves in the parasympathetic and sensory nerves of the lesion mucosa in the hypersensitive reaction area of ​​the nasal septum and the corresponding nasal septum, sensory nerve endings and stimuli receptors can be destroyed to varying degrees, reducing their sensitivity. Furthermore, microwave therapy can induce the production of protein coagulation enzymes on the surface of the nasal mucosa to prevent the invasion of external sensitizing substances, thereby alleviating nasal symptoms. It should be noted that the above-mentioned microwaves have the same energy output as radiofrequency. Although they are mostly used to treat tumors due to their large effective area, excessive energy output, and difficulty in achieving targeted therapy, those skilled in the art can still adjust the appropriate power and irradiation method to make microwave energy suitable for ablation surgery in biological cavities.

[0065] In this embodiment, the ablation energy of the energy module 10 can be a radio frequency pulse current. (Continue reading...) Figure 2The energy module 10 includes a signal generation unit 11 connected to the control module 30, a signal filtering unit 12 electrically connected to the signal generation unit 11, and a power amplification unit 13 (e.g., a power amplifier) ​​electrically connected to the signal filtering unit 12. The power amplification unit 13 is also connected to the transmission module 20. The signal generation unit 11 is used to generate an ablation signal, specifically a radio frequency pulse signal. In one embodiment, the signal generation unit 11 generates the ablation signal based on Direct Digital Synthesis (DDS) technology. For example, the signal generation unit 11 generates a 469kHz sine wave signal as the current output ablation signal. DDS technology directly digitally synthesizes signals based on the concepts of phase and amplitude, and has the advantages of high frequency resolution and low output noise. Moreover, based on digital synthesis technology, the amplitude of the signal can be easily controlled by a program, while also being low in cost and power consumption. The signal filtering unit 12 is used to perform low-pass filtering on the ablation electrical signal at a preset frequency. For example, due to the inherent characteristics of DDS technology, its output signal inevitably contains a large number of stray spectral lines. Therefore, after the signal is generated, it needs to be connected to the signal filtering unit 12 for low-pass filtering to remove stray signals in the high-frequency band, thereby outputting a high-quality ablation electrical signal. The signal filtering unit 12 can be, for example, a Butterworth filter, which has no ripple in the passband, has the flattest response, and has minimal output distortion. The power amplification unit 13 is used to amplify the ablation electrical signal processed by the signal filtering unit 12 by a preset factor to obtain the ablation energy. The power amplification unit 13 can boost the power of the ablation electrical signal and enhance its load capacity. In one embodiment, the circuit structure of the power amplification unit 13 can be built based on operational amplifiers and power transistors (such as transistors and MOSFETs). Taking into account the RF output power and impedance matching of the signal generation unit 11, the energy module 10 is designed to meet the requirements of pre-stage signal amplification, power matching, and post-stage signal power amplification. This avoids the problems of low circuit efficiency and overheating of power transistors caused by direct power amplification in the overall circuit structure, thus improving safety performance. It should be noted that those skilled in the art can configure the preset frequency of the signal filtering unit 12 and the preset multiplier of the power amplification unit 13 according to actual conditions.

[0066] Description of delivery module 20: Delivery module 20 has the characteristics of a linear body. The proximal end of delivery module 20 is connected to energy module 10, and the distal end of delivery module 20 can extend into the biological cavity and abut against the target area 50 of the biological cavity to transmit the ablation energy provided by energy module 10 to the target area 50 of the biological cavity, thereby performing ablation treatment on the target area 50 and realizing non-invasive targeted ablation treatment. After delivery module 20 abuts against the target area 50, it can also detect the temperature of the target area 50 in real time and feed the temperature back to control module 30.

[0067] Figure 4 This is a schematic diagram of a conveying module 20 according to an embodiment of the present invention. (See attached diagram.) Figure 4 The delivery module 20 includes a catheter 21 and an ablation head 22. The proximal end of the catheter 21 is connected to the energy module 10 to mechanically fix the catheter 21 to the energy module 10. The ablation head 22 is located at the distal end of the catheter 21 and is electrically connected to the energy module 10 and the control module 30, respectively. The cable used for electrical connection can be concealed in the catheter 21, so that after the ablation head 22 is brought into contact with the target area 50, ablation energy is transmitted to the target area 50 of the biocavitary for ablation, and the temperature generated in the target area 50 during ablation is detected in real time by the ablation head 22. As a further implementation detail, the delivery module 20 also includes a handle 23, which is disposed on the catheter 21. The doctor can control the catheter 21 by holding the handle 23, thereby extending the catheter 21 and the ablation head 22 into the biocavitary.

[0068] Preferably, see below. Figure 2 A portion of the catheter 21 is configured as a curved segment 210, which is connected to the ablation head 22. For example, the portion of the catheter 21 defined between the handle 23 and the ablation head 22 is the curved segment 210. The curved segment 210 can be offset relative to the axis of the catheter 21, thereby allowing the curved segment 210 to bend, for example, by approximately 20° relative to the axis of the catheter 21 itself. The configuration of the curved segment 210 can be based on the cavitary structural features of the biological cavity, allowing the catheter 21 to be better navigated during insertion to precisely apply the ablation head 22 to the target area 50.

[0069] See Figure 2 The biocavitary ablation system also includes a human-machine interface module 40. The navigation of the catheter 21 and ablation head 22 within the biocavitary can be monitored through the visualization components of the human-machine interface module 40. These visualization components include an endoscope and a display 43. The endoscope is inserted into the biocavitary to acquire endoscopic images, which are then visualized on the display 43. This ensures that the physician can monitor the real-time position of the catheter 21 and ablation head 22, such as whether the ablation head 22 is aligned with the target area 50. Furthermore, the endoscope is inserted into the biocavitary to acquire endoscopic images of the target area 50, and the physician can monitor the ablation progress of the target area 50 in real-time via the display 43.

[0070] Figure 5This is a schematic diagram of an ablation head 22 according to an embodiment of the present invention. The ablation head 22 includes a substrate 221, a plurality of ablation electrodes 222, and a temperature detection unit 223. The substrate 221 is made of an insulating material, such as polyimide. The substrate 221 is disposed at the distal end of the conduit 21. The substrate 221 has a reference surface 2210. Preferably, the reference surface 2210 is parallel to the axis of the curved tube segment 210. The shape of the substrate 221 is, for example, cuboid. The plurality of ablation electrodes 222 are mounted on the substrate 221 at intervals and are all located on the reference surface 2210. For example, the ablation electrodes 222 are embedded in the substrate 221. The ablation electrodes 222 are electrically connected to the energy module 10. The cable connecting the ablation electrodes 222 to the energy module 10 can be concealed in the conduit 21. The ablation electrodes 222 are sheet-shaped and are used to adhere to the target area 50 to transmit ablation energy to the target area 50. All ablation electrodes 222 can be bipolar electrodes, or some electrodes can be positive electrodes and others negative electrodes. A temperature detection unit 223 is mounted on the substrate 221 and located on the reference surface 2210. For example, both ends of the temperature detection unit 223 are embedded in the substrate 221. The temperature detection unit 223 is in contact with the target area 50 to detect the temperature of the target area 50. The temperature detection unit 223 is communicatively connected to the control module 30, thereby feeding back the detected temperature to the control module 30. Furthermore, there is a gap between the temperature detection unit 223 and the ablation electrodes to avoid mutual interference.

[0071] In one embodiment, the temperature detection unit 223 is a thermocouple temperature sensor. Thermocouple temperature sensors have a simple structure, provide accurate measurements, and have an ideal temperature range. They can be used as direct-contact temperature measurement instruments, and are unaffected by intermediate media. Specifically, the temperature of the target region 50 is obtained by mapping the resistance of the thermistor within the thermocouple temperature sensor to the temperature, forming a temperature signal. This temperature signal can be converted into a digital signal by an A / D conversion circuit and provided to the control module 30.

[0072] Continue reading Figure 5 Furthermore, multiple ablation electrodes 222 are arranged collinearly to form a group of electrode rows, and the ablation head 22 includes at least two groups of said electrode rows arranged at intervals and side by side (e.g., Figure 5The demonstrated left and right electrode rows have a temperature detection unit 223 located between adjacent electrode rows, with both the ablation electrode 222 and the temperature detection unit 223 embedded in the substrate 221. This design ensures that the reference surface 2210 effectively conforms to the target area 50, guaranteeing that the temperature detection unit 223 and the ablation electrode 222 can effectively adhere to the target area 50, resulting in better ablation and more accurate temperature detection in the target area 50. Furthermore, it avoids interference from the current signal on the electrodes with the temperature detection unit 223. It should be noted that in the two adjacent electrode rows, one electrode row exhibits positive polarity after acquiring ablation energy, while the other electrode row exhibits negative polarity. Preferably, the vertical distance from the ablation electrode 222 to the reference surface 2210 is equal to the vertical distance from the temperature detection unit 223 to the reference surface 2210. As the user applies a certain pressure to the target area 50 during use, the ablation electrode 222 is able to release a certain amount of ablation energy (such as radio frequency energy) after making full contact with the tissue of the target area 50. At the same time, the temperature of the target area 50 can be effectively monitored and fed back to the control module 30.

[0073] Furthermore, the bending of the curved tube segment 210 can be controlled using an auxiliary tool (not shown). This tool is connected to the catheter 21 and allows the curved tube segment 210 to bend at any angle. The doctor also uses the auxiliary tool to apply conductive gel to the ablation electrode 222. The auxiliary tool is a disposable medical consumable. In addition, the ablation electrode 222, the substrate 221, and the temperature detection unit 223 of the catheter 21 and ablation head 22 are also disposable medical consumables, avoiding the risk of cross-infection due to excessive reuse.

[0074] Furthermore, the human-computer interaction module 40 also includes a touch component connected to the control module 30. The touch component is triggered to cause the control module 30 to adjust the working state of the energy module 10. Specifically, when the touch component is triggered, it sends a signal to the control module 30. The control module 30 controls the energy module 10 to change the output of ablation energy, or directly controls the energy module 10 to stop working. In one embodiment, the output of ablation energy can be controlled by the number of times the touch component is touched. For example, each time the touch component is touched, the output of ablation energy increases by a fixed value. Further, after the touch component has been continuously triggered for a certain period of time, the energy module 10 can be controlled to stop working. The touch component can be, for example, a foot pedal 41 connected to the control module 30. The doctor presses the foot pedal 41 to trigger it. The number of times the foot pedal 41 is triggered is the number of times it is pressed. Continuous triggering of the foot pedal 41 is considered as prolonged pressing of the foot pedal 41. The touch component can also be a button 42, which can be located on the handle 23. The doctor presses the button 42 to trigger it. The number of times the button 42 is triggered is the number of times it is pressed. Continuous triggering of the button 42 is considered as prolonged pressing of the button 42. By configuring the touch component, the doctor can remotely control the output of ablation energy, and in the event of a major malfunction, the doctor can remotely interrupt the surgery, improving the system's safety performance while conforming to ergonomic design.

[0075] Description of Control Module 30: Control Module 30 is used to detect in real time the parameter values ​​corresponding to the ablation energy generated by Energy Module 10. These parameter values ​​include voltage and / or current values. Based on the parameter values ​​of the ablation energy and the temperature of the target area 50 fed back by Delivery Module 20, Control Module 30 adjusts the ablation energy in real time. This includes, but is not limited to, adaptively adjusting the output energy value of the ablation energy according to the temperature and the detected parameter values ​​to match the temperature generated during ablation, controlling Energy Module 10 to stop outputting ablation energy, and interrupting the line for Delivery Module 20 to acquire ablation energy so that no radiofrequency current is delivered to ablation electrode 222. This improves the safety factor during ablation treatment, and the reference to temperature and voltage / current can provide feedback to adjust the energy value of the ablation energy, ensuring that the temperature of the target area 50 is maintained at a certain value, achieving uniform heating and ablation. In one embodiment, see [reference needed]. Figure 2 The control module 30 includes a microcontroller 31 (e.g., a single-chip microcomputer) and a temperature controller 32 that communicates with the microcontroller. The temperature controller 32 is connected to the temperature detection unit 223 of the delivery module 20, acquires the temperature fed back by the temperature detection unit 223, and feeds the temperature back to the microcontroller 31. The microcontroller 31 detects the voltage and current values ​​of the ablation energy. The current value can be obtained by first acquiring the voltage through a sampling resistor, and then obtaining the sampled current value according to Ohm's law.

[0076] The biocavity ablation system of this invention achieves ablation therapy based on the biological principle of cells (i.e., cell death due to heat). Determining cell death requires observing the local temperature of the target tissue (i.e., the temperature of the target region 50 in this embodiment). During ablation therapy, this invention further uses the detected ablation energy current value and the temperature of the target region 50 to provide feedback and regulate the ablation energy, thus providing a biological monitoring and feedback function. This improves the safety factor of the ablation energy output process, preventing the actual temperature of the target region 50 from becoming too high, ensuring safe and gentle ablation therapy, and reducing the likelihood of postoperative complications for patients. Furthermore, by simultaneously referencing the current value and the temperature of the target region 50 to regulate the ablation energy, more detailed treatment plans can be established through extensive clinical trials.

[0077] To illustrate, taking the ablation energy as a radio frequency signal, the biocavitary ablation system includes a signal routing circuit module connected to both the energy module and the delivery module. The radio frequency signal generated by the energy module 10 can be divided into at least two paths by the signal routing circuit module composed of relays. One path goes to the voltage and current monitoring circuit, which allows the control module 30 to obtain the voltage through the sampling resistor and then acquire the current value of the radio frequency signal. The other path goes to the delivery module 20, which supplies the ablation electrode 222 for radio frequency ablation.

[0078] Typically, the control module 30 adjusts the output magnitude of the ablation energy of the energy module 10 by adjusting the duty cycle of its own output PWM signal. Further, the control module 30 is configured to execute steps S1, S2, S3, and S4, wherein:

[0079] S1: The control module 30 sequentially acquires the current value corresponding to the ablation energy at each sampling time in a series of consecutive sampling times. That is, the control module 30 obtains the ablation energy at sampling time t. m To t m+n The current values ​​corresponding to each sampling time in the data are given, where n is greater than or equal to 3, m is greater than or equal to 0, and m and n are both integers.

[0080] For example, the current value I1 is collected at sampling time t1, the current value I2 is collected at sampling time t2, the current value I3 is collected at sampling time t3, and the current value I4 is collected at sampling time t4.

[0081] S2: Calculate the sampling time t respectively. m+1 To t m+n The current values ​​corresponding to each sampling time and the sampling time t m The difference between the corresponding current values ​​yields (n-1) different deviation values.

[0082] For example, the deviation between I2 and I1 is △1 = I2 - I1, the deviation between I3 and I1 is △2 = I3 - I1, and the deviation between I4 and I1 is △3 = I4 - I1.

[0083] S3: Obtain the current increment based on (n-1) different deviation values, and based on the current increment and the sampling time corresponding to t m+n The current value is obtained at sampling time t m+n+1 The corresponding current value, sampling time t m+n+1 The corresponding current value is equal to the sampling time t. m+n The sum of the current value and the current increment, i.e., I m+n+1 =I m+n +△I,I m+n+1 Indicates sampling time t m+n+1 The corresponding current value, I m+n Indicates the sampling time corresponding to t m+n The current value is ΔI, where ΔI represents the current increment.

[0084] When n equals 3, the current increment is equal to the sampling time t. m+2 The corresponding deviation value and sampling time t m+1 The difference in the corresponding deviation values ​​is used to calculate the current increment based on the PID adaptive control algorithm, which can be programmed in the temperature controller 32. For example, if three consecutive sampling times are selected in a certain period of time, namely t2, t3, and t4, then ΔI = Δ3 - Δ2.

[0085] When n is greater than 3, the current increment is equal to the average of (n-1) different deviation values. For example, if four consecutive sampling times are selected in a certain period of time, namely t1, t2, t3, and t4, then ΔI = (Δ1 + Δ2 + Δ3) / 3.

[0086] S4: Based on sampling time t m+n+1 The corresponding current value outputs a PWM signal with a corresponding duty cycle, and the energy module 10 is controlled to output the ablation energy according to the PWM signal.

[0087] Thus, the control module 30 executes the above steps, collecting real-time current to provide feedback for controlling the output of ablation energy, improving the control accuracy of the ablation energy output, and ensuring a uniform temperature rise in the target area 50. It should be noted that steps S1, S2, and S3 can be executed in the temperature controller 32 of the control module 30, while step S4 can be executed in the microcontroller 31.

[0088] Furthermore, the control module 30 controls the energy module 10 to stop generating ablation energy according to preset conditions, and generates an alarm signal according to preset conditions; the preset conditions are configured as follows: the current value of the ablation energy is greater than a current threshold, and / or, the temperature of the target area 50 is greater than a temperature threshold. When the control module 30 detects that the current value of the ablation energy is greater than the current threshold or the temperature of the target area 50 is greater than the temperature threshold, it controls the energy module 10 to stop the output of ablation energy to protect the patient and avoid secondary injury. During this process, the control module 30 will also generate an alarm signal to alert the doctor that the current ablation status is dangerous. For example, the alarm signal can be a sensory signal, such as an auditory signal (sound), a visual signal (image, color, etc.), or an audiovisual signal (a combination of visual and auditory signals). In one embodiment, for example, the control module 30 is connected to an alarm device that can generate an alarm signal; for example, the alarm component can be a buzzer.

[0089] Optionally, the control module 30 also has a built-in timer, which can be configured with different timing periods (e.g., 30 seconds, 1 minute). This allows doctors to use the timer to perform periodic ablation treatments on patients. Specifically, during pre-operative preparation, the doctor manipulates the control module 30 to select the corresponding timing period in the timer. After the ablation procedure begins, the timer starts counting down (either forward or backward). After the countdown ends, the timer sends a feedback signal to the control module 30, which then controls the energy module 10 to stop outputting ablation energy, marking the end of one treatment cycle. Of course, the doctor can also choose not to use the timer and decide when to stop treatment based on the actual progress. Optionally, the system can generate a prompt signal after one timing period to notify the doctor that the current treatment cycle has ended. The prompt signal and the alarm signal can share the same signal or be two separate signals.

[0090] Figure 6 This is a flowchart of a biological cavity ablation system according to an embodiment of the present invention, for reference. Figure 6 The working process of the biocavity ablation system of the present invention will be described in detail.

[0091] The first step is to perform preoperative preparations, including system initialization, by resetting and initializing the corresponding parameters of the timer, the PWM signal of the control module 30, the ablation electrical signal of the signal generation unit 11 of the transmission module 20, and the A / D conversion circuit.

[0092] The second step is to set the parameters in the signal generation unit 11 so that the signal generator outputs an ablation electrical signal of the corresponding frequency, such as a 460KHz sine wave signal.

[0093] The third step is to determine whether to trigger the timer. If the timer is triggered, select the timer setting to confirm the timer's timing period. Then, the timer will start timing and proceed to the fourth step. If the timer is not triggered, proceed directly to the fourth step.

[0094] The fourth step involves using an A / D conversion circuit and a sampling resistor to collect the voltage values ​​corresponding to the ablation energy at multiple consecutive sampling times. Based on the collected voltage values ​​and the sampling resistor, the current values ​​of the ablation energy at each sampling time are calculated, and then low-pass filtering and power amplification are performed.

[0095] The fifth step is to determine whether the collected current value is greater than the current threshold. If yes, proceed to the ninth step; otherwise, proceed directly to the sixth step.

[0096] The sixth step involves calculating the deviation value and current increment based on the multiple filtered current values, thereby calculating the actual current required for the next sampling moment, and outputting a PWM signal with the corresponding duty cycle based on the actual current, and then controlling the ablation energy output of the energy module 10 based on the PWM signal.

[0097] Step 7: The A / D conversion circuit converts the temperature signal fed back by the temperature detection unit 223 into a digital signal and sends it to the control module 30. The control module 30 compares whether the temperature of the target area 50 is greater than the temperature threshold. If it is, it proceeds directly to step 9; otherwise, it proceeds to step 8.

[0098] Step 8: Has the timer reached its timing period? If yes, proceed to step 9; otherwise, return to step 3.

[0099] In the ninth step, the control module 30 stops outputting the PWM signal so that the ablation energy output of the energy module 10 is zero, and the alarm component generates an alarm signal.

[0100] Figure 7 This is a self-test flowchart of a biological cavity ablation system according to an embodiment of the present invention. (Reference) Figure 7 The self-testing process of the biological cavity ablation system of the present invention is described in detail.

[0101] When the power switch is turned on, the system begins a self-test. If the self-test is normal, the system will enter the insertion interface for the electrode 21. If the self-test is abnormal, the screen of the display 43 will display an error message, and the system will automatically power off. After successful insertion and recognition of the electrode 21, the main interface of the display 43 will switch to the standby interface. The user can step on the foot pedal 41 to enter the working interface of the display 43. At this time, various parameters of the RF pulse output can be set, and the user can choose to start the timer to begin the countdown (the user can select, use the default, or customize the timing period). After that, the system will enter the cooling interface of the display 43. If the user uses the system improperly (for example, not applying conductive gel to the electrode head), the shield of the display 43 will start to display a warning (or the alarm component may generate an alarm signal), and the system will return to the standby interface of the display 43. Under correct use, the workflow of the display 43 is: main interface — standby interface — working interface — cooling interface — countdown ends — return to main interface.

[0102] Based on the same inventive concept as the aforementioned biocavity ablation system, this invention also provides a biocavity ablation method, which includes:

[0103] Deliver ablation energy to the target area within the biological cavity;

[0104] Real-time detection of parameter values ​​corresponding to the generated ablation energy, and real-time detection of temperature values ​​in the target area, including voltage and / or current values;

[0105] The ablation energy is adjusted in real time based on the parameter values ​​and the temperature of the target area.

[0106] Furthermore, the step of adjusting the ablation energy according to the parameter value includes:

[0107] Obtain the ablation energy at sampling time t m To t m+n The current values ​​corresponding to each sampling time in the data;

[0108] Calculate the sampling time t respectively m+1 To t m+n The current values ​​corresponding to each sampling time and the sampling time t m The difference between the corresponding current values ​​yields (n-1) different deviation values;

[0109] The current increment is obtained based on (n-1) different deviation values, and the current increment is based on the sampling time t. m+n The corresponding current value is obtained at sampling time t. m+n+1 The corresponding current value;

[0110] Based on sampling time t m+n+1The corresponding current value outputs a PWM signal with a corresponding duty cycle, and the energy module is controlled to output the ablation energy according to the PWM signal;

[0111] Where n is greater than or equal to 3, m is greater than or equal to 0, and m and n are both integers.

[0112] Furthermore, when n equals 3, the current increment is equal to the sampling time t. m+2 The corresponding deviation value and sampling time t m+1 The difference between the corresponding deviation values; when n is greater than 3, the current increment is equal to the average of (n-1) different deviation values.

[0113] It should be noted that the biocavitary ablation method and the biocavitary ablation system are based on the same inventive concept and have the same or corresponding specific technical features. Those skilled in the art can understand the biocavitary ablation method here based on the biocavitary ablation system, which will not be elaborated here.

[0114] Based on the above-described biocavity ablation method, this invention also provides a storage medium storing a readable and writable program. When the program is executed, it can realize the biocavity ablation method as described above. Specifically, the biocavity ablation method provided by this invention can be programmed or software and stored on the storage medium. In actual use, the program stored on the storage medium is used to execute each step of the biocavity ablation method.

[0115] In summary, the biocavity ablation system, biocavity ablation method, and storage medium provided by this invention include an energy module, a delivery module, and a control module. The energy module generates ablation energy to the target area of ​​the biocavity. The delivery module transmits the ablation energy to the target area of ​​the biocavity and monitors the temperature of the target area in real time. The control module monitors the parameter values ​​corresponding to the ablation energy generated by the energy module in real time, including voltage and / or current values. Both the delivery module and the energy module are connected to the control module. The control module adjusts the ablation energy of the energy module in real time based on the parameter values ​​and the temperature of the target area fed back by the delivery module. With this configuration, this invention uses the detected voltage and / or current values ​​of the ablation energy and the temperature of the target area to regulate the ablation energy during ablation treatment, achieving a biological monitoring and feedback function. This improves the safety factor of the ablation energy output process, thereby avoiding excessively high actual temperatures in the target area, ensuring safe and gentle ablation treatment, and reducing the probability of postoperative complications for patients. Furthermore, the delivery module extends into the biological cavity and attaches to the target area to transmit ablation energy without penetrating the tissue within the biological cavity. This ensures that the invented biological cavity ablation system is performed in a non-invasive manner, accurately delivering ablation energy to the nerve-dense areas of the target region while minimizing damage to surrounding tissues, improving patient comfort, enhancing ablation treatment efficacy, and reducing postoperative recovery time.

[0116] The above description is only a description of preferred embodiments of the present invention and is not intended to limit the scope of the present invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure shall fall within the protection scope of the present invention.

Claims

1. A biological cavity ablation system, characterized in that, include: An energy module, used to generate ablation energy to the target area in the biological cavity; A delivery module is used to transmit the ablation energy to the target area and to detect the temperature of the target area in real time; A control module is used to detect in real time the parameter values ​​corresponding to the ablation energy generated by the energy module. The parameter values ​​include current values ​​and / or voltage values. Both the delivery module and the energy module are connected to the control module. The control module adjusts the ablation energy of the energy module in real time according to the parameter values ​​and the temperature value of the target area fed back by the delivery module. The control module is configured to execute: Obtain the ablation energy at sampling time t m To t m+n The current values ​​corresponding to each sampling time in the data; Calculate the sampling time t respectively m+1 To t m+n The current values ​​corresponding to each sampling time and the sampling time t m The difference between the corresponding current values ​​yields (n-1) different deviation values; The current increment is obtained based on (n-1) different deviation values, and the current increment is based on the sampling time t. m+n The corresponding current value is obtained at sampling time t. m+n+1 The corresponding current value; Based on sampling time t m+n+1 The corresponding current value outputs a PWM signal with a corresponding duty cycle, and the energy module is controlled to output the ablation energy according to the PWM signal; Where n is greater than or equal to 3, m is greater than or equal to 0, and m and n are both integers.

2. The biological cavity ablation system according to claim 1, characterized in that, The energy module includes: Signal generating unit, which is used to generate ablation electrical signals; A signal filtering unit is used to perform low-pass filtering on the ablation electrical signal at a preset frequency. A power amplification unit is used to amplify the ablation electrical signal processed by the signal filtering unit by a preset factor to obtain the ablation energy.

3. The biological cavity ablation system according to claim 1, characterized in that, The delivery module includes a catheter and an ablation head. The proximal end of the catheter is connected to the energy module, and the ablation head is located at the distal end of the catheter. The ablation head is used to transmit the ablation energy to the target area of ​​the biological cavity, and the ablation head is used to detect the temperature of the target area.

4. The biological cavity ablation system according to claim 3, characterized in that, The catheter has a curved section connected to the ablation head, and the curved section can be offset relative to the axis of the catheter.

5. The biological cavity ablation system according to claim 3, characterized in that, The ablation head includes: A substrate connected to the conduit, the substrate having a reference surface; Multiple ablation electrodes are mounted on the substrate at intervals and are all located on the reference plane. The ablation electrodes are electrically connected to the energy module. A temperature detection unit is mounted on the substrate and located on the reference surface; the temperature detection unit is communicatively connected to the control module.

6. The biological cavity ablation system according to claim 5, characterized in that, The ablation head includes at least two sets of electrode rows arranged side by side at intervals. Each set of electrode rows includes multiple ablation electrodes arranged collinearly. The temperature detection unit is located between two adjacent sets of electrode rows.

7. The biological cavity ablation system according to claim 1, characterized in that, The control module controls the energy module to stop generating the ablation energy according to preset conditions, and generates an alarm signal according to the preset conditions; the preset conditions are configured as follows: the current value of the ablation energy is greater than a current threshold, and / or, the temperature of the target area is greater than a temperature threshold.

8. The biological cavity ablation system according to claim 1, characterized in that, The biocavitary ablation system further includes a human-computer interaction module, which includes a touch component and / or a visualization component; the touch component is connected to the control module, and the touch component is triggered to drive the control module to adjust the working state of the energy module; the visualization component includes an endoscope and a display, the endoscope is used to extend into the biocavitary space to acquire endoscopic images of the target area, and the display is used to visualize the endoscopic images.

9. The biological cavity ablation system according to claim 1, characterized in that, When n equals 3, the current increment is equal to the sampling time t. m+2 The corresponding deviation value and sampling time t m+1 The difference between the corresponding deviation values; When n is greater than 3, the current increment is equal to the average of (n-1) different deviation values.

10. The biological cavity ablation system according to claim 1, characterized in that, The biocavity ablation system includes a signal routing circuit module connected to both the energy module and the delivery module. The signal routing circuit module divides the ablation energy into at least two signals. One signal is routed to the control module so that the control module can detect the parameter value of the ablation energy, and the other signal is routed to the delivery module to transmit the ablation energy to the target area.

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