Ophthalmic radio frequency ablation system, radio frequency ablation instrument, and control method therefor

Abstract

The present application relates to the field of ophthalmic radio frequency ablation and provides an ophthalmic radio frequency ablation system, a radio frequency ablation instrument, and a control method therefor. The radio frequency ablation system comprises: an ablation electrode comprising a sharp-tipped electrode needle for puncturing ocular tissues; and a radio frequency ablation host comprising a control module, a radio frequency module, an input / output module, an impedance detection module, and an information reading module. The radio frequency module is used for providing radio frequency energy for the ablation electrode connected to the radio frequency ablation host. The impedance detection module is used for detecting impedance information of the ocular tissues during ablation. The information reading module is used for acquiring electrode information of the ablation electrode and / or writing use information of the ablation electrode recorded by the radio frequency ablation host into the ablation electrode. This ophthalmic ablation system can not only carry out precise radio frequency ablation therapy on different ocular tissues and simplify the operation steps and reduce difficulty of users, but also determine whether radio frequency ablation conditions are met or not and thereby to ensure the safety of the radio frequency ablation therapy process.

Description

Ophthalmic radiofrequency ablation system, radiofrequency ablation instrument and control method thereof Cross-references

[0001] This application refers to the Chinese invention patent applications No. 202311851506.9 filed on December 29, 2023, entitled “A Ophthalmic Radiofrequency Ablation System” and No. 202311850706.2 filed on December 29, 2023, entitled “A Ocular Radiofrequency Ablation Device and Its Control Method”, both of which are incorporated herein by reference in their entirety. Technical Field

[0002] This specification relates to the field of eye treatment, and in particular to an ophthalmic radiofrequency ablation system, a radiofrequency ablation apparatus, and a control method thereof. Background Art

[0003] Radiofrequency ablation technology mainly implements ablation through the thermal effect on the biological body. When radiofrequency current flows through human tissue, the rapid change of the electromagnetic field causes the polar water molecules in the tissue to move at high speed, generating heat (i.e., endogenous thermal effect), causing the water inside and outside the cells to evaporate, dry, shrink and fall off, resulting in aseptic necrosis, thereby achieving the purpose of treatment.

[0004] Due to the smaller tissue structure of the eye, higher requirements are placed on radiofrequency ablation electrodes, ablation accuracy, clinical operability, and treatment safety. Currently, there is no mature radiofrequency ablation technology for eye tissue.

[0005] Therefore, it is hoped that an ophthalmic radiofrequency ablation system can be provided to achieve precise radiofrequency ablation of ocular tissues, treat eye diseases such as glaucoma, and make clinical operations more convenient and safer. Summary of the Invention

[0006] One or more embodiments of the present specification provide an ophthalmic radiofrequency ablation system, the system comprising: an ablation electrode, the ablation electrode comprising an electrode needle with a tip and an operating handle, the electrode needle being mounted on the operating handle, the tip being used to penetrate into eye tissue to ablate the eye tissue based on radiofrequency energy; a radiofrequency ablation host, the radiofrequency ablation host comprising a power module, a control module, a radiofrequency module, an input / output module, an impedance detection module, and an information reading module; wherein the radiofrequency module is configured to generate a radiofrequency signal based on a control instruction sent by the control module when the ablation electrode is electrically connected to the radiofrequency ablation host. , to provide the RF energy to the ablation electrode; the impedance detection module is configured to detect the impedance information of the eye tissue during the ablation process and transmit the impedance information to the control module; and the information reading module is configured to obtain the electrode information of the ablation electrode after the ablation electrode is electrically connected to the RF ablation host, and transmit the electrode information to the control module, and / or write the usage information of the ablation electrode recorded by the control module into the ablation electrode; the power supply module is configured to supply power to the control module, the RF module, the input / output module and each module communicating with the control module.

[0007] One or more embodiments of the present specification provide an ophthalmic radiofrequency ablation system, the system comprising: a radiofrequency ablation host for providing radiofrequency energy; accessories connected to the radiofrequency ablation host, the accessories comprising a foot switch and an ablation electrode; the foot switch is used to control the output and stop of the radiofrequency energy, and the ablation electrode is used to perform ablation based on the radiofrequency energy; wherein the ablation electrode comprises: an electrode needle, the electrode needle is cylindrical as a whole, and its cross-section comprises an electrode inner pole, a first insulating layer, an electrode outer pole, and a second insulating layer from the inside to the outside in the radial direction, the outer surfaces of the front ends of the electrode inner pole, the first insulating layer, the electrode outer pole, and the second insulating layer correspondingly form an inner pole region, a first insulating region, an outer pole region, and a second insulating region, and after the ablation electrode is connected to the radiofrequency ablation host, an ablation wave is generated between the inner pole region and the outer pole region; and an adjustment component, the adjustment component is inserted into the outer surface of the electrode needle and can move axially relative to the electrode needle to adjust the length of the electrode needle exposed from the adjustment component.

[0008] The ophthalmic radiofrequency ablation system provided in this embodiment, which includes an ablation electrode and a radiofrequency ablation host, can perform precise radiofrequency ablation treatment on different eye tissues, while simplifying the user's operating steps and difficulty, making the radiofrequency ablation treatment process simpler and faster. It can also determine whether the conditions for radiofrequency ablation are met, thereby ensuring the safety and standardization of the radiofrequency ablation treatment process.

[0009] In one or more embodiments of the present specification, an ocular radiofrequency ablation device is further provided, which is used to provide radiofrequency energy to the ablation electrode connected thereto. The ocular radiofrequency ablation device includes: a control module, a radiofrequency module, an impedance detection module and an information reading module; the control module is used to communicate with the radiofrequency module, the impedance detection module and the information reading module to control the radiofrequency ablation device to generate the radiofrequency energy; the radiofrequency module is used to generate radiofrequency energy based on the control instruction of the control module; the radiofrequency module includes a radiofrequency power supply, a radiofrequency signal source and a power amplifier module, wherein: the radiofrequency power supply is connected to the control module and the power amplifier module to provide electrical energy for the generation of the radiofrequency energy; the radiofrequency signal source is connected to the control module and the power amplifier module to generate radiofrequency signals based on the control instructions; the power amplifier module is used to generate alternating current radiofrequency energy based on the radiofrequency signal and the electrical energy; the impedance detection module is used to detect impedance information before, during or after the output of the radiofrequency energy; the information reading module is used to obtain electrode information of the ablation electrode when the ablation electrode is connected to the radiofrequency ablation device.

[0010] In some embodiments, the control module is further used to: verify the ablation electrode based on the electrode information obtained by the information reading module; give a prompt in response to the ablation electrode being unavailable; or display the electrode type and electrode life information of the ablation electrode and request confirmation in response to the ablation electrode being available.

[0011] In some embodiments, the availability of the ablation electrode includes: the ablation electrode is not an illegal electrode and is within the validity period, and the remaining number of uses or the remaining ablation time of the ablation electrode is not zero.

[0012] In some embodiments, the expiration date includes the expiration date on the ablation electrode packaging and the preset usage time range after unpacking and first use, and the electrode life information includes the number of times the electrode has been used and the remaining number of uses, or the accumulated ablation time and the remaining ablation time.

[0013] In some embodiments, the ocular radiofrequency ablation device also includes a foot switch interface for connecting a foot switch, and the control module is further used to: detect whether the foot switch is connected in response to the electrode type and electrode life information of the ablation electrode being confirmed; give a prompt in response to the foot switch not being connected; and enter the parameter setting interface in response to the foot switch being connected or the user clicking the confirmation button in the prompt interface.

[0014] In some embodiments, the control module is further used to: recommend target parameters in response to user confirmation of the electrode type and electrode life information of the ablation electrode; preferably, based on the electrode type of the ablation electrode, recommend parameter values ​​related to the target parameters or user-selectable parameter ranges; preferably, the target parameters include the output duration and output power of the radio frequency energy.

[0015] In some embodiments, the ocular radiofrequency ablation device also includes an activation switch, and the control module is further used to: give a prompt in response to abnormal activation of the activation switch; the abnormal activation of the activation switch includes: the activation switch is activated when a first preset condition is not met, and the first preset condition includes that all functions of the radiofrequency ablation device are normal, the foot switch is connected, the ablation electrode is available and the target parameters have been determined.

[0016] In some embodiments, the control module is further used to: enter a treatment interface in response to the activation switch being activated when the first preset condition is met; the information displayed on the treatment interface includes at least one of electrode status, electrode type, electrode life, output duration of radio frequency energy, real-time treatment time, output power of radio frequency energy, and impedance information; preferably, the information displayed on the treatment interface includes electrode status, electrode type, electrode life information, output power of radio frequency energy, output duration of radio frequency energy, real-time treatment time, and real-time impedance.

[0017] In some embodiments, the control module is further used to: issue a prompt in response to abnormal activation of the foot switch; the abnormal activation of the foot switch includes: the foot switch is activated when a second preset condition is not met; the second preset condition includes the radiofrequency ablation device entering the treatment interface.

[0018] One or more embodiments of the present specification provide a control method for a radiofrequency ablation instrument; the method includes: in response to the radiofrequency ablation instrument being turned on, detecting whether the functions of the radiofrequency ablation instrument are normal; in response to all functions of the radiofrequency ablation instrument being normal, detecting whether the ablation electrode connected to the radiofrequency ablation instrument is available; in response to the ablation electrode being available and the electrode information being confirmed, entering a parameter setting interface; in response to the ablation electrode being available before or after the electrode information is confirmed, detecting whether a foot switch is connected; in response to the foot switch being connected and based on the target parameters recommended by the parameter setting interface or set in the parameter setting interface, controlling the output or stopping of radiofrequency energy.

[0019] In some embodiments, detecting whether the function of the radiofrequency ablation device is normal includes at least one of the following: detecting whether the foot switch and / or activation switch is abnormally started; detecting whether the status of the analog-to-digital converter of the radiofrequency ablation device is normal; detecting whether the size of the radiofrequency output frequency is normal; detecting whether the real-time clock is accurate; detecting whether the serial port communication is normal; detecting whether the power supply is normal; and detecting whether the reading and writing of the memory are normal.

[0020] In some embodiments, detecting whether the real-time clock is accurate includes: comparing the time of the real-time clock with the latest device recorded time, if the time of the real-time clock is before the device recorded time, determining that the real-time clock is inaccurate; and / or in response to the real-time clock being inaccurate, reminding after-sales maintenance personnel to adjust the time.

[0021] In some embodiments, controlling the output or stopping of radio frequency energy based on the target parameters recommended by the parameter setting interface or set in the parameter setting interface further includes: judging whether the ablation electrode has reached the target position in response to the activation switch being activated when a first preset condition is met; determining that the ablation electrode has reached the target position in response to the impedance information reaching a preset value or the ablation electrode reaching a predetermined depth; and when the ablation electrode reaches the target position, controlling the output of the radio frequency energy based on the target parameters in response to the foot switch being activated.

[0022] In some embodiments, the process of controlling the output or stopping of the RF energy further includes: controlling the RF energy to stop outputting when a sudden change in impedance occurs; or automatically stopping the RF energy output in response to the foot switch being released, the activation switch being turned off, or the timing reaching the output duration of the RF energy.

[0023] One or more embodiments of this specification provide a computer-readable storage medium, wherein the storage medium stores computer instructions. When a computer reads the computer instructions in the storage medium, the computer executes the control method as described above.

[0024] The ocular radiofrequency ablation device and control method provided in this embodiment can perform precise ocular radiofrequency ablation treatment on different ocular tissues to treat eye diseases such as glaucoma. It can be connected to the ablation electrode and read the stored information of the ablation electrode, and monitor the impedance changes during the treatment process in real time, making the radiofrequency ablation treatment process simpler and faster. It can also determine whether the conditions for radiofrequency ablation are met, ensuring the safety and standardization of the radiofrequency ablation treatment process, while simplifying the user's operating steps and difficulty. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] This specification will be further described in the form of exemplary embodiments, which will be described in detail with reference to the accompanying drawings. These embodiments are not limiting, and in these embodiments, like numbers represent like structures, wherein:

[0026] FIG1 is an exemplary schematic diagram of an ophthalmic radiofrequency ablation system according to some embodiments of the present specification;

[0027] 2A and 2B are exemplary schematic diagrams of a trolley of a radiofrequency ablation apparatus according to some embodiments of the present specification;

[0028] FIG3 is an exemplary schematic diagram of the hardware structure of a radiofrequency ablation apparatus according to some embodiments of this specification;

[0029] FIG4 is a schematic diagram of the hardware structure of an ophthalmic radiofrequency ablation system according to other embodiments of this specification;

[0030] FIG5 is a software / hardware schematic diagram of a microcontroller unit according to some embodiments of the present specification;

[0031] 6A and 6B are exemplary schematic diagrams of radiofrequency ablation apparatus structures according to some embodiments of the present specification;

[0032] FIG7 is an exemplary schematic diagram of an ablation electrode according to some embodiments of the present specification;

[0033] FIG8A is an exemplary schematic diagram of an electrode needle according to some embodiments of the present specification;

[0034] FIG8B is an exemplary schematic diagram of the internal structure of an electrode needle according to some embodiments of this specification;

[0035] FIG9A is a schematic diagram of an embodiment of a regulating tube according to some embodiments of this specification;

[0036] FIG9B is a schematic diagram of another embodiment of a regulating tube according to some embodiments of this specification;

[0037] FIG10 is a schematic diagram of another embodiment of an electrode needle according to some embodiments of this specification;

[0038] FIG11 is a schematic diagram of an embodiment of an electrode needle according to some embodiments of this specification;

[0039] FIG12A is a schematic diagram of an embodiment of an electrode needle according to some embodiments of this specification;

[0040] FIG12B is a schematic diagram of another embodiment of an electrode needle according to some embodiments of this specification;

[0041] FIG13 is a schematic diagram of an embodiment of an electrode needle according to some embodiments of this specification;

[0042] FIG14 is an exploded schematic diagram of an ablation electrode according to some embodiments of the present specification;

[0043] FIG15 is a cross-sectional view of a handle tip of an ablation electrode according to some embodiments of the present specification;

[0044] FIG16 is an exemplary schematic diagram of an electrode needle protection cap according to some embodiments of this specification;

[0045] FIG17 is an exploded schematic diagram of an operating handle in an ablation electrode according to the present invention;

[0046] FIG18 is an exemplary flow chart of an ophthalmic radiofrequency ablation method according to some embodiments of the present specification;

[0047] FIG19 is an exemplary schematic diagram of an ophthalmic radiofrequency ablation method according to some embodiments of the present specification;

[0048] FIG20 is an exemplary schematic diagram of a display page for replacing electrodes according to some embodiments of this specification;

[0049] FIG21 is an exemplary schematic diagram of a warning information display page according to some embodiments of this specification;

[0050] FIG22 is an exemplary schematic diagram of a confirmation page for electrode identification after the ablation electrode is electrically connected according to some embodiments of the present specification;

[0051] FIG23 is a schematic diagram of a parameter setting page before treatment according to some embodiments of this specification;

[0052] FIG24 is an exemplary schematic diagram of an information display page during a treatment process according to some embodiments of the present specification;

[0053] FIG25 is an exemplary diagram of a system setting page according to some embodiments of the present specification; and

[0054] FIG26 is an exemplary schematic diagram of a time setting interface according to some embodiments of this specification;

[0055] FIG27 is an exemplary module diagram of an ocular radiofrequency ablation apparatus according to some embodiments of the present specification;

[0056] FIG. 28 is an exemplary flowchart of a control method according to some embodiments of the present specification. DETAILED DESCRIPTION

[0057] In order to more clearly illustrate the technical solutions of the embodiments of this specification, the following briefly introduces the drawings required for describing the embodiments. The drawings do not represent all implementation methods.

[0058] It should be understood that the terms "system," "device," "unit," and / or "module" used herein are a method for distinguishing different components, elements, parts, portions, or assemblies at different levels. If other terms can achieve the same purpose, the terms may be replaced by other expressions.

[0059] As used in this specification and claims, unless the context clearly indicates otherwise, the words "a," "an," "an," and / or "the" do not refer to the singular but also include the plural. Generally speaking, the terms "comprises" and "include" only indicate the inclusion of the steps and elements specifically identified, and these steps and elements do not constitute an exclusive list. A method or apparatus may also include other steps or elements.

[0060] When operations are performed according to the step descriptions in the embodiments of this specification, unless otherwise specified, the order of the steps is interchangeable, steps can be omitted, and other steps can be included in the operation process.

[0061] FIG1 is an exemplary schematic diagram of an ophthalmic radiofrequency ablation system according to some embodiments of the present specification.

[0062] As shown in FIG. 1 , in some embodiments, an ophthalmic radiofrequency ablation system 100 may include a radiofrequency ablation host 110 (ie, a radiofrequency ablation device 110 ), an ablation electrode 120 , and a connector 130 .

[0063] In some embodiments, the ablation electrode 120 may include a needle electrode with a sharp tip and an operating handle. The needle electrode is mounted on the operating handle; the sharp tip can be used to penetrate ocular tissue to ablate the ocular tissue using radiofrequency energy. Ocular tissue refers to the tissue area to be ablated. For example, ocular tissue may include the ciliary body, trabecular meshwork, iris, and sclera. For more details about the ablation electrode, see Figures 7-17.

[0064] The radiofrequency ablation device 110 is configured to provide radiofrequency energy to the ablation electrode after the ablation electrode is electrically connected to the radiofrequency ablation host. In some embodiments, the ablation host 110 may include a control module, a radiofrequency module, an input / output module, an impedance detection module, and an information reading module. Among them, the control module can be configured to control the ablation host 110 to achieve ablation of eye tissue. The radiofrequency module can be configured to generate a radiofrequency signal based on the control instruction sent by the control module after the ablation electrode 120 is electrically connected to the radiofrequency ablation host 110, so as to provide radiofrequency energy to the ablation electrode 120. The impedance detection module can be configured to detect the impedance information of the eye tissue during the ablation process and transmit the impedance information to the control module so that the control module issues corresponding control instructions based on the changes in the impedance information (such as controlling the radiofrequency module to start or stop the output of radiofrequency energy, controlling the input / output module to output warning information, etc.). The information reading module can be configured to, when the ablation electrode 120 is electrically connected to the RF ablation host 110, obtain electrode information from the ablation electrode and transmit this information to the control module, so that the control module can determine whether the ablation electrode is usable based on the electrode information. The information reading module can also be configured to write the ablation electrode usage information recorded by the RF ablation host 110 to the corresponding ablation electrode. For more details about the RF ablation host, please refer to Figures 3-6B.

[0065] The connector 130 is configured to connect the ablation electrode 120 and the radiofrequency ablation host 110. The connector 130 may include an aviation plug, an N-type connector, an SMA connector, and the like.

[0066] In some embodiments, the ophthalmic radiofrequency ablation system 100 may further include a foot switch. The foot switch can be connected to the radiofrequency ablation host 110 via a cable to control the output and stop of radiofrequency energy. For example, the foot switch can be connected to one end of the cable, and the other end of the cable is plugged into the foot switch interface on the radiofrequency ablation host 110 (such as the foot switch interface 664 in Figure 6A or 6B), thereby being electrically connected to the radiofrequency ablation host 110. When the foot switch is electrically connected to the radiofrequency ablation host 110, if the radiofrequency energy output conditions are met (such as the ablation electrode is available, the ablation parameters are determined, the ablation electrode reaches the target position and there are no other errors in the radiofrequency ablation host, etc.), the user can control the radiofrequency energy output by stepping on the foot switch, and release the foot switch to control the stop of radiofrequency energy output.

[0067] In some embodiments, as shown in FIG2A or 2B , the ophthalmic RF ablation system 100 may further include a trolley 140. The trolley 140 is configured to carry the RF ablation device 110. In some embodiments, the RF ablation device 110 may be fixedly mounted or detachably mounted on the trolley 140. When the RF ablation device 110 is mounted on the trolley 140, the RF ablation device 110 may be moved by moving the trolley 140 (e.g., to a user's location).

[0068] As shown in Figures 2A or 2B, in some embodiments, the trolley 140 may include a front handle 210, a rear push handle 220, a storage box 230, a cable hook, a body, and casters. The front handle 210 may be located at the front of the trolley 140 to pull the trolley, thereby moving the mounted RF ablation device 110. The rear push handle 220 may be located at the rear of the trolley 140 to propel the trolley 140. The storage box 230 may be located at the rear bottom of the trolley 140 to store items (such as cables, documents, masks, gloves, and patient belongings). In some embodiments, the storage box 230 may also be located at the front or side of the trolley 140. The front of the trolley may refer to the side where the display interface of the RF ablation device 110 is located after the trolley 140 is mounted on the trolley 140; accordingly, the rear refers to the side opposite the front. The cable hook structure may include a wire hanging shaft and a baffle; the cable is wound around the wire hanging shaft, and the baffle is used to prevent the cable from falling. The body refers to the main part of the trolley, which can provide a stable center of gravity for the trolley, support the radiofrequency ablation device, etc. The caster refers to the structure that provides the trolley with a mobile function. The caster may include fixed casters, brake casters, and universal casters. In some embodiments, the front casters may be two universal casters, and the rear casters may be two brake casters.

[0069] As shown in FIG2B , in some embodiments, the trolley 140 may further include a locking member 240 for securing the RF ablation device. As shown in FIG2B , the locking member 240 may be positioned above the platform 250 of the trolley 140, with a knob connected to the locking member 240 positioned at the bottom of the platform 250. The RF ablation device may be provided with a fixing structure (such as fixing structure 650) that matches the locking member 240. By rotating the knob, the locking member 240 can be locked or unlocked with the fixing structure, thereby securing or detaching the RF ablation device 110 from the trolley 140. In some embodiments, the locking member 240 may comprise various reasonable shapes, such as a rectangular parallelepiped, a cube, or an irregular shape, though this specification does not impose specific limitations thereon. In some embodiments, the fixing structure may include a locking member and a locking hole, which rotates within the locking hole to secure or detach the RF ablation device. The locking member and locking hole may be positioned on the bottom of the RF ablation device and on the trolley, respectively. The fixing structure may also be in the form of other structures that secure the RF ablation device 110 to the trolley. For example, the fixing structure is a snap-fit ​​structure, including an elastic member and a groove, which are respectively provided on the radiofrequency ablation device 110 and the trolley, and are fixed to the groove through deformation of the elastic member.

[0070] FIG3 is an exemplary schematic diagram of the hardware structure of a radiofrequency ablation host according to some embodiments of this specification.

[0071] As shown in FIG. 3 , in some embodiments, the RF ablation host 110 may include a RF module 112 , a control module 113 , an input / output module 114 , an impedance detection module 115 , and an information reading module 116 .

[0072] The control module 113 is configured to control the radiofrequency ablation host 110 to perform radiofrequency ablation on eye tissue.

[0073] In some embodiments, the control module 113 can be communicatively connected to the RF module 112, input / output module 114, impedance detection module 115, and information reading module 116 in the RF ablation host 110. The control module 113 can read information from the connected modules or send control instructions to control the RF ablation host 110. For example, the control module 113 can read ablation parameters from the input / output module 114 and control the RF module 112 to output RF energy based on the ablation parameters. For another example, the control module 113 can receive impedance information of ocular tissue detected by the impedance detection module 115 and, based on the impedance information, determine whether the ablation electrode has reached the target location in the eye. For another example, the control module 113 can receive electrode information of the ablation electrode obtained by the information reading module 116 and, based on the electrode information, determine whether the ablation electrode is usable. If so, the control module 113 controls the input / output module 114 (e.g., display screen 610) to output the electrode information. If not, the control module 114 controls the input / output module 114 to output a warning message (e.g., "Electrode verification failed, please replace the electrode" or "Electrode life expired, please replace the electrode"). For another example, the control module 113 can detect the operating status of the RF ablation host and / or its accessories (such as a foot switch, ablation electrode), determine the occurrence of a warning or error, and output a warning message or prompt sound through the input / output module 114. For more information about this part, please refer to the relevant description below.

[0074] In some embodiments, the control module 113 may include a microcontroller unit (MCU). The MCU can be used to implement analog-to-digital signal conversion, serial communication, SPI (Serial Peripheral Interface) communication, IIC (Inter-Integrated Circuit) communication, signal timing capture, timing control, digital control state identification and logic control, and RF voltage and current calculations. For more information about the MCU, see FIG5 .

[0075] The RF module 112 can be configured to generate a RF signal based on the control instruction sent by the control module 113 when the ablation electrode is electrically connected to the RF ablation host 110, so as to provide RF energy (such as RF energy with a peak value in the range of 0-300V) to the ablation electrode.

[0076] In some embodiments, as shown in FIG. 4 , the RF module 112 may include a RF signal source 1121 , a RF power supply 1122 , and a power amplification module 1123 .

[0077] RF signal source 1121 is connected to control module 113 and is configured to generate RF signals based on control instructions from control module 113. For example, RF signal source 1121 can generate RF signals of corresponding frequency and amplitude based on signal generation instructions sent by control module 113 containing information such as frequency and amplitude. In some embodiments, RF signal source 1211 can be connected to control module 113 via a predetermined connection method. The predetermined connection method may include an electrical connection, a communication connection, or the like.

[0078] In some embodiments, the RF signal may include an analog signal or a digital signal. For example, the RF signal source 1121 may be a DDS signal generator for generating a digital signal. For another example, the RF signal source 1121 may be based on a phase-locked loop (PLL) and may adjust the parameters (such as frequency, amplitude, etc.) of the RF signal through an RC circuit (Resistor-Capacitance circuit) to generate an analog signal. A PLL-based RC circuit (Resistor-Capacitance circuit) refers to a circuit that adjusts the signal frequency of the output signal based on the phase difference between the input signal and the output signal.

[0079] In some embodiments, the radio frequency signal may be in the range of 300 KHz to 3 MHz, for example, 500 KHz, 700 KHz, 900 KHz, 1 MHz, 2 MHz, etc.

[0080] In some embodiments, the radio frequency signal may include a weak current waveform, a square wave, a sine wave, and a triangle wave.

[0081] The RF power supply 1122 is connected to the control module 114 and the power amplifier module 1123 to provide electrical energy for the generation of RF energy. In some embodiments, the RF power supply can generate direct current with a voltage range of 0 to 80 V, for example, 10 V, 30 V, 50 V, 80 V, etc.

[0082] In some embodiments, RF power supply 1122 may include a voltage adjustable power supply.

[0083] The voltage-adjustable power supply, also known as a voltage-controlled power supply, is configured to adjust its voltage to a target value based on control instructions sent by the control module 113, so that the RF module 112 generates an RF signal with a predetermined output power. For example, after the user sets the output power of the RF signal, the control module 113 can adjust the voltage of the voltage-adjustable power supply for the current ablation procedure based on the output power of the RF signal, so that the electrical energy output by the RF power supply 1122 can be generated by the power amplifier module to generate the RF energy required for RF ablation.

[0084] In some embodiments, the RF power supply 1122 may be a fixed voltage power supply. In this case, the RF module 112 may adjust the output power of the RF signal by adjusting the output parameters (such as frequency, amplitude, etc.) of the RF signal source 1121, or by adjusting the amplification power parameters of the power amplifier module 1123 to control the output power of the RF signal.

[0085] The power amplifier module 1123 is connected to the RF signal source 1121 and is configured to amplify the electrical energy generated by the RF power supply 1122 to generate RF energy based on the RF signal output by the RF signal source 1121. As shown in FIG4 , one end of the power amplifier module 1123 is connected to the RF signal source 1121, and the other end is connected to the RF power supply 1122. In some embodiments, the RF energy may include AC RF energy.

[0086] In some embodiments, the power amplifier module 1123 can amplify the direct current generated by the radio frequency power source under the radio frequency signal output by the radio frequency signal source to form a changing alternating current radio frequency energy.

[0087] In some embodiments, the power amplification module 1123 may include a Class D power amplifier. A Class D power amplifier is an electronic amplifier that amplifies a low-power signal into a high-power signal. Compared to conventional Class A, Class B, or Class AB power amplifiers, a Class D power amplifier has higher efficiency and lower power loss.

[0088] In some embodiments, the power amplifier module 1123 can generate RF energy in a variety of ways. For example, the power amplifier module can generate RF energy using a power switch in conjunction with a transformer using a preset topology. For another example, the power amplifier module can generate RF energy using a power amplifier in conjunction with a transformer or an audio power amplifier circuit. Preset topologies can include flyback, push-pull, and full-bridge topologies. Power switches can include MOSFETs, IGBTs, Darlington transistors, and the like.

[0089] The input / output module 114 is configured to control the start and stop of RF energy output (such as by activating a switch, a foot switch, etc.), and / or set ablation parameters (such as by setting through a touch screen display), and display treatment information, electrode information and / or prompt information to the user (such as by displaying through a display screen).

[0090] In some embodiments, as shown in FIG4 , the input / output module 114 may include a human-computer interaction unit (input module) 1141 and an output unit 1142. The human-computer interaction unit 1141 may be used to control the start and stop of RF energy output and / or set ablation parameters. The output unit 1142 may be used to display treatment information, electrode information, and / or prompt information to the user. For details about ablation parameters, treatment information, electrode information, and prompt information, please refer to the following description.

[0091] Ablation parameters refer to parameters used when performing radiofrequency ablation on eye tissue. In some embodiments, ablation parameters may include output power of the radiofrequency signal, treatment time, treatment mode, etc.

[0092] Different electrode types are used for different ocular tissues targeted by radiofrequency ablation. For example, for radiofrequency ablation of different ocular tissues such as the ciliary body, trabecular meshwork, iris, and sclera, the electrode types can be ciliary body electrodes, trabecular meshwork electrodes, iris electrodes, and sclera electrodes, respectively. When performing radiofrequency ablation on different tissues, the ablation parameters are primarily the same as those listed above.

[0093] In some embodiments, the RF ablation system can automatically detect and identify the electrode type of the ablation electrode connected to the system, display the type of the electrode, and request user confirmation (see Figure 18). Based on the electrode type, the system can recommend RF therapy parameters. Automatic detection and identification of the connected electrode type by the system eliminates the need for operator selection, making it safer and preventing the operator from selecting the wrong type.

[0094] The output power of the RF signal reflects the power of RF ablation. In some embodiments, the output power can be in the range of 0.5-50W. For example, the output power can be any value in the range of 0.5-9.9W. In some embodiments, the output power of the RF signal can be obtained in a variety of ways. For example, in response to the availability of the ablation electrode and the user's confirmation, the RF ablation host can provide multiple alternative output powers for the user to choose according to the electrode type or control the optional output power within the recommended range. In response to the user selecting or setting one of the alternative output powers through a preset input method, the selected alternative output power is determined as the output power of the RF signal. For more instructions on determining whether the ablation electrode is available, please refer to the relevant description below.

[0095] In some embodiments, the alternative output power can be pre-set based on historical experience and the patient's actual situation. For example, the alternative output power can be determined based on the output power of the RF signal used in a completed RF ablation procedure. In some embodiments, the alternative output power can have a range of values ​​(e.g., 0.5-9.9W) or multiple specific values.

[0096] The treatment time refers to the treatment time at a location after each insertion when performing radiofrequency ablation on ocular tissue. In some embodiments, the treatment time can be obtained in a variety of ways. For example, in response to the availability of an ablation electrode, the control module 113 can provide multiple alternative treatment times based on the electrode type and control the input / output module 114 to display them on the display interface for the user to select, or control the optional treatment time to be within a recommended range based on the electrode type. When the user selects or sets one of the alternative treatment times through a preset input method, the selected alternative treatment time is determined as the treatment time.

[0097] In some embodiments, the alternative treatment time can also be pre-set based on historical experience and the patient's actual situation. For example, the alternative treatment time can be determined based on the treatment time used in a completed radiofrequency ablation procedure. In some embodiments, the alternative treatment time can be a time range (e.g., 1-20 seconds, 10-100 seconds, etc.), or multiple specific time values.

[0098] In some embodiments, the treatment mode may include a continuous treatment mode and / or a single treatment mode.

[0099] Continuous treatment mode means that after the tip of the electrode needle enters the eye tissue, RF energy can be released multiple times at the same treatment location, that is, released intermittently. The corresponding treatment time is the accumulation of multiple release times. Correspondingly, single treatment mode means that RF energy is released once each time the tip of the electrode needle enters the eye tissue. The corresponding treatment time is the duration of this RF energy release.

[0100] In some embodiments, the treatment information may include treatment time, output power of the radio frequency signal, real-time impedance, etc.

[0101] The treatment time refers to the time during which radiofrequency ablation has been performed at a radiofrequency ablation site. In some embodiments, the control module 113 can determine the treatment time by a timer and output it through the input / output module 114 (such as the display screen 610).

[0102] Real-time impedance can be used to characterize the real-time impedance of ocular tissue. For more information about real-time impedance, please refer to the following description.

[0103] Electrode information refers to information related to the ablation electrode. In some embodiments, the electrode information may include the electrode type, electrode validity period information, and electrode life information of the ablation electrode. Preferably, the electrode validity period information may include the electrode production date, production shelf life, first use time, and a preset usage time range after the first use. Preferably, the electrode life information may include the number of uses, the remaining number of uses, or the accumulated ablation time and the remaining ablation time. For instructions on electrode types, please refer to the relevant description above. For more instructions on electrode validity period information and electrode life information, please refer to the relevant description below.

[0104] In some embodiments, the prompt information may include accessory connection status and / or warning information.

[0105] Accessories refer to components that need to be connected to the RF ablation main unit through cables or other means. For example, accessories may include ablation electrodes 120, foot switches, etc.

[0106] The accessory connection status may represent the connection between the accessory and the RF ablation host. In some embodiments, the accessory connection status may include whether the foot switch or ablation electrode is connected to the RF ablation host or whether the foot switch or ablation electrode is not connected to the RF ablation host.

[0107] In some embodiments, the control module 113 can automatically detect the accessory connection status and send the accessory connection status to the input / output module 114 for display.

[0108] The warning information can prompt the user to perform corresponding operations based on the warning information. For example, in response to the ablation electrode being disconnected from the RF ablation host, the control module 113 can control the input / output module 114 to output the warning message "electrode not connected" so that the user can check the connection status of the ablation electrode.

[0109] In some embodiments, the warning message may include information such as electrode not connected, electrode not authorized or verification failed, electrode life ended, electrode expired, foot switch not connected, self-test failed, please release the activation switch, please release the foot switch, etc. For example, in response to the ablation electrode being an illegal electrode, the control module 113 may control the output unit to output the warning message "electrode not authorized." For more information about legal electrodes, please refer to the relevant content below.

[0110] In some embodiments, the human-computer interaction unit 1141 may include at least one of a foot switch, an activation switch (such as activation switch 450), and an input button. For example, the input button is configured to set ablation parameters and may include a keyboard, a mouse, a virtual button (such as a function button on a touch screen display), a real button, etc. In some embodiments, in response to the user setting the ablation parameters via the input button, the control module may determine the ablation parameters. The output unit may include a display screen (such as display screen 610), an audio device 430 (such as a speaker), etc.

[0111] In some embodiments, the input / output module 114 may include a touch screen display. In this case, the input button of the human-computer interaction unit 1141 may be integrated with the output unit.

[0112] Activation switch 450 is used to activate the RF module after a first preset condition is met. The first preset condition is that the accessory connection status with the RF ablation mainframe is connected, the ablation electrode is available, the ablation parameters have been set, and the RF ablation mainframe has no other errors (all functions are normal). For information on whether the ablation electrode is available, please refer to the relevant description below.

[0113] When the first preset condition is met, the activation switch is turned on, and the control module can control the radio frequency module to generate radio frequency energy.

[0114] It should be noted that the activation switch is not controlled by software, but by the RF signal. If the activation switch is turned off, the RF generation circuit will be in a closed state, and the control module will not send a control signal for RF output, making it impossible to control RF energy output.

[0115] During the ablation process of eye tissue, if the output of RF energy is abnormal or an emergency occurs (such as patient physical abnormality, equipment failure, etc.), the user turns off the activation switch and the RF module 112 stops outputting RF energy.

[0116] In some embodiments, in response to abnormal activation of the activation switch during a power-on self-test process or other non-RF output process (e.g., activation when a first preset condition is not met), the control module 113 may send a warning message to the input / output module 114, and the output unit 1142 of the input / output module 114 may display the warning message to prompt the user. The warning message may include, for example, "Please release the activation switch."

[0117] The foot switch is configured to control the start and stop of the radio frequency energy output after a second preset condition is met.

[0118] The second preset condition is that after the first preset condition is met, the ablation electrode is inserted into the eye tissue and reaches the target position. Preferably, the second preset condition can be that the display interface enters the treatment interface.

[0119] In some embodiments, the connection method between the foot switch and the radiofrequency ablation host 110 may include cable connection or wireless network connection.

[0120] In some embodiments, in response to the foot switch being disconnected from the RF ablation host 110, the control module 113 may send a warning message to the input / output module 114, and the output unit 1142 in the input / output module 114 may output the warning message. The warning message may include, for example, "foot switch not connected."

[0121] In some embodiments, in response to abnormal activation of the foot switch (e.g., activation when the second preset condition is not satisfied), the control module 113 may send a warning message to the input / output module 114, and the output unit 1142 of the input / output module 114 may output the warning message. The warning message may include, for example, "Please release the foot switch."

[0122] In some embodiments, the ophthalmic radiofrequency ablation system 100 may be configured to have a continuous output mode and / or a timed output mode, wherein the continuous output mode or the timed output mode may reflect the output manner of radiofrequency energy.

[0123] Continuous output mode means that in response to the user activating the foot switch, control module 113 controls RF module 112 to begin outputting RF energy, and in response to the user deactivating the foot switch or activating the switch, control module 113 controls RF module 112 to stop outputting RF energy. In some embodiments, continuous output mode is suitable for performing multiple RF treatments on the same ocular tissue.

[0124] In some embodiments, in response to each activation of the foot switch by the user, the input / output module 114 can display the elapsed treatment time for each RF energy delivery.

[0125] In timed output mode, in response to a user activating the foot switch, the control module 113 controls the RF module 112 to begin outputting RF energy and start timing. When the timing reaches a preset time threshold, the RF energy output automatically ceases. In some embodiments, in response to the user turning off the foot switch or activating the switch before the timing reaches the preset time threshold, the control module 113 can control the RF module 112 to cease outputting RF energy. In some embodiments, the preset time threshold can be the treatment time or less.

[0126] In some embodiments, in continuous treatment mode, when the RF ablation host begins outputting RF energy and timing begins, the output unit 1142 of the input / output module 114 can display the real-time timing. In some embodiments, the output unit 1142 can simultaneously display the timing information along with the number of treatments completed and / or the treatment time. In some embodiments, the displayed real-time timing can be updated synchronously with the restart of the timing after each time count ends.

[0127] In some embodiments, in response to the user pressing the foot switch for more than a preset time, the control module 113 can control the RF module 112 to start outputting RF energy. The preset time may include 1 second, 2 seconds, etc.

[0128] In some embodiments, in response to the foot switch not being released when the timer reaches a preset time threshold, the control module 113 may send a warning message to the input / output module 114, and the output unit 1142 in the input / output module 114 may output the warning message. The warning message may include "Please release the foot switch."

[0129] In some embodiments, in continuous output mode or timed output mode, each time the output of RF energy is stopped, the RF ablation host can record the usage information of the ablation electrode and update the electrode life information of the currently used ablation electrode. For an explanation of the electrode life information, please refer to the relevant description below.

[0130] In some embodiments, the RF ablation system can determine the impedance of the ocular tissue based on the impedance information obtained by the impedance detection module 115 before delivering RF energy. If the impedance of the ocular tissue is 0 or is not within a preset impedance threshold range, the RF ablation system will not deliver RF energy even if the user activates the foot switch, thereby further ensuring the safety of RF ablation. The preset impedance threshold range refers to the range of impedance information when the tip of the ablation electrode is inserted into the location to be treated, and can be pre-set.

[0131] The impedance detection module 115 is configured to detect the impedance of the ocular tissue during the ablation process and transmit this information to the control module. For example, before RF energy is delivered, in response to the user inserting the ablation electrode into the patient's ocular tissue, the impedance detection module may detect the impedance of the ocular tissue. This impedance information may include real-time impedance.

[0132] In some embodiments, as shown in FIG. 4 , the impedance detection module 115 may include an impedance monitoring unit 1151 and a voltage and current feedback unit 1152 .

[0133] The impedance monitoring unit 1151 is configured to monitor the impedance information of the eye tissue before and after the RF energy is output.

[0134] In some embodiments, the impedance monitoring unit 1151 may include a bio-impedance detection chip.

[0135] In some embodiments, the impedance monitoring unit 1151 can obtain impedance information of the ocular tissue and send the impedance information to the control module 113. The control module 113 controls the input / output module 114 to display the impedance information of the ocular tissue. The impedance information can help the user determine whether the tip of the ablation electrode is inserted into the location requiring treatment (i.e., the target location).

[0136] In some embodiments, as shown in FIG. 4 , the impedance monitoring unit 1151 may be connected to the control module 113 and the ablation electrode 120 via an electrode switching unit.

[0137] The electrode switching unit is configured to connect the ablation electrode 120 to the impedance monitoring unit 1151 or to connect the ablation electrode 120 to the RF module 112. In some embodiments, the electrode switching unit may include a single-pole double-throw switch, such as a relay switch, an analog switch, or a switch circuit.

[0138] In some embodiments, in response to before the RF energy starts to be output or after the output stops, the control module 113 may control the single-pole double-throw switch to connect the impedance monitoring unit 1151 to the ablation electrode 120 .

[0139] In some embodiments, in response to outputting RF energy, the control module 113 may control a single-pole double-throw switch to connect the RF module 112 to the ablation electrode 120 , so that the RF module 112 provides RF energy to the ablation electrode 120 .

[0140] It is understandable that the electrode switching unit can ensure that the impedance monitoring unit 1151 and the RF module 112 are not turned on at any time, thereby avoiding device failure due to RF energy entering the impedance monitoring unit 1151.

[0141] The voltage and current feedback unit 1152 is configured to monitor the impedance information of the eye tissue during the output of radio frequency energy.

[0142] In some embodiments, the voltage and current feedback unit 1152 may include a current and voltage sampling unit.

[0143] The current and voltage sampling unit is configured to collect current and voltage feedback signals and calculate impedance information based on the collected current and voltage feedback signals. In some embodiments, the voltage and current feedback unit 1152 can send the collected current and voltage values ​​to the control module 113, which calculates the real-time impedance.

[0144] In some embodiments, the current and voltage sampling unit may include a mutual inductor, a Hall-type voltage and current sensor, and a sampling resistor. In some embodiments, the current and voltage sampling unit obtains impedance information through various methods. For example, the current and voltage sampling unit may collect current and voltage feedback signals, convert the AC current and voltage signals into DC current and voltage signals through a rectifier circuit, and calculate the impedance information using a resistance calculation formula. The resistance calculation formula includes Ohm's law.

[0145] In some embodiments, the current and voltage sampling unit 1152 can obtain the impedance information of the eye tissue and send the impedance information to the control module 113, which controls the input / output module 114 to output the impedance information of the eye tissue. It should be noted that the impedance information can help the user judge the change between the actual RF power and the set RF power. The set RF power is the maximum power during the treatment process. During the treatment process, the target tissue loses water and the impedance increases. Power P = U 2 / R, the voltage remains unchanged and the power will gradually decrease; therefore, the change in impedance information can reflect the degree of RF ablation; when the impedance suddenly changes (that is, it indicates that the degree of RF ablation has met the conditions for stopping RF energy output), the RF energy output will be stopped even if the timer has not reached the treatment time, which can further ensure the safety of RF ablation.

[0146] The information reading module 116 is configured to obtain electrode information of the ablation electrode 120 after the ablation electrode 120 is electrically connected to the RF ablation host 110, transmit the electrode information to the control module 113, and / or write the usage information of the ablation electrode recorded by the RF ablation host into the ablation electrode.

[0147] In some embodiments, in response to the ablation electrode 120 being electrically connected to the RF ablation host 110 , the information reading module 116 may automatically obtain the electrode information of the ablation electrode 120 and send it to the control module 113 .

[0148] In some embodiments, after ablation is completed, in response to the remaining service life of the ablation electrode being not 0, the control module 113 may actively write the usage information of the ablation electrode recorded by the radiofrequency ablation host into the ablation electrode.

[0149] In some embodiments, the ablation electrode 120 may include a memory chip configured to store electrode information of the ablation electrode.

[0150] In some embodiments, the electrode information may include the chip model, encryption information, electrode type, model, electrode validity period information, electrode life information, and data verification code of the ablation electrode. Among them, the encryption information refers to the information used to verify whether the electrode is a legally authorized electrode. The first use time refers to the time when the ablation electrode is first connected to the radiofrequency ablation host. The data verification code can be used to verify that the data obtained by the input / output module is consistent with the data in the storage chip or can be matched or paired to determine whether the ablation electrode is legal. The data verification code may include a CRC verification code. The electrode validity period information may include the production date, production shelf life, first use time, and a preset use time range after the first use. The electrode life information may include the number of uses and the remaining number of uses, or the accumulated ablation time and the remaining ablation time.

[0151] The manufacturing date is the date the ablation electrode leaves the factory. The shelf life is the time from the manufacturing date to the expiration date of the ablation electrode. The first use time is the time when the ablation electrode is first connected to the RF ablation host.

[0152] The preset usage time range after the first use can reflect the interval time after the ablation electrode is used for ablation again after the last use. For example, after ablation electrode A is unsealed and used to complete eye tissue ablation, the remaining service life is not 0, and the ablation end time is 10 am on December 1st. To ensure aseptic operation, the preset usage time range after the first use can be set to 4 hours (or 2 hours, 3 hours, 5 hours, 6 hours, 8 hours, etc.) after the first use. If the electrode A is used for ablation again at 1 pm on December 1st, the time interval between the two uses is 3 hours, which is less than 4 hours, so it is within the preset usage time range; if it is used for ablation again at 3 pm on December 1st, the time interval between the two uses is 5 hours, which is greater than 4 hours, so it exceeds the preset usage time range. When such an electrode is connected, the radiofrequency ablation host will remind you that the electrode has expired.

[0153] In some embodiments, when the ablation electrode 120 is connected to the RF ablation host 110 for the first time, the RF ablation host 110 may proactively write the first use time into the storage chip of the ablation electrode 120 .

[0154] In some embodiments, the remaining number of uses and the number of uses (or the accumulated ablation time and the remaining ablation time) can be actively updated and written into the memory chip of the ablation electrode 120 by the RF ablation host 110 each time the ablation electrode is connected. In some embodiments, each time the ablation electrode is used, the remaining number of uses in the memory chip is reduced by 1 and the number of uses is increased by 1.

[0155] In some embodiments, the accumulated ablation time and the remaining ablation time (or the remaining number of uses and the number of uses) can be actively updated and written into the storage chip of the ablation electrode 120 by the RF ablation host 110 after each use of the ablation electrode. In some embodiments, in response to the end of each ablation electrode use, the accumulated ablation time in the storage chip can be increased by the duration of the single ablation electrode use, and the remaining ablation time can be reduced by the duration of the single ablation electrode use.

[0156] In some embodiments, in response to the end of ablation, and the remaining service life of the ablation electrode is not 0 and the usage time does not exceed the preset usage time range, the control module can actively write the electrode information stored in the radiofrequency ablation host (such as the remaining number of uses, the number of uses, etc.) into the storage chip.

[0157] In some embodiments, the memory chip may be integrated into the electrode operating handle, or integrated into the plug of the aviation plug cable connecting the electrode operating handle and the radiofrequency ablation host.

[0158] In some embodiments, the RF ablation host 110 may determine whether the ablation electrode is available based on the acquired electrode information.

[0159] A usable ablation electrode means it's legal, within its valid use period, and has a remaining usable lifespan (remaining number of uses or remaining ablation time) of not less than 0. A legal electrode is a verified, authorized electrode used with the RF ablation device. The valid use period can include the manufacturer's warranty period and the pre-set usage timeframe.

[0160] In some embodiments, the control module 113 can determine whether the ablation electrode is available in a variety of ways. For example, the control module can verify the encryption information of the ablation electrode. If the encryption information is correct, it determines that the ablation electrode is a legally authorized electrode. At the same time, it checks whether the ablation electrode has exceeded the effective use period and the remaining available life. If the ablation electrode has not exceeded the effective use period and the remaining available life is not 0, it determines that the ablation electrode is available. Among them, the encryption information can be constructed in a variety of ways, for example, symmetric encryption, asymmetric encryption, etc. Exemplarily, the encryption information of the ablation electrode is constructed by symmetric encryption. When the control module receives the encrypted information, it can decrypt the encrypted information by using a key. If it cannot be decrypted or the decrypted information is incorrect, the control module can determine that the ablation electrode is an illegal electrode and control the output module to output a warning message, such as "The electrode is illegal, please replace the electrode."

[0161] In some embodiments, in response to the ablation electrode 120 being disconnected from the RF ablation host 110, the control module 113 may send a warning message to the input / output module 114 to control the input / output module 114 to output the warning message. For example, the warning message may include "electrode not connected."

[0162] In some embodiments, in response to the control module 113 determining that the ablation electrode is unavailable, the control module 113 may send a warning message to the input / output module 114 to control the input / output module 114 to output the warning message. For example, the warning message may include "electrode not authorized" or "electrode verification failed", "electrode life end", or "electrode expired".

[0163] In some embodiments, in response to the ablation electrode being available, the control module 113 can send electrode information to the input / output module 114 to control the input / output module 114 to output the electrode information for user confirmation. FIG22 is an exemplary schematic diagram of a confirmation page for electrode identification after the ablation electrode is electrically connected according to some embodiments of this specification. As shown in FIG22 , when the connected ablation electrode is available, the control module 113 can control the display screen 610 to display information such as the electrode type and electrode life as shown in FIG22 . If the electrode type and electrode information are correct, the user can click the "Confirm" button in the interactive interface 2000 to confirm and proceed to the next step.

[0164] In some embodiments, as shown in FIG3 , the RF ablation host 110 may further include a power module 111 .

[0165] The power module 111 is configured to supply power to the control module 113 , the RF module 112 , the input / output module 114 , and modules communicating with the control module 113 .

[0166] In some embodiments, the power module 111 can be electrically connected to the control module 113 to supply power to the control module, and at the same time supply power to the remaining modules in the RF ablation host (such as the input / output module 114, the impedance detection unit 1151, the voltage and current feedback unit 1152, the information reading module 116, etc.) through the control module.

[0167] In some embodiments, the voltage output by the power module 111 may range from 5 to 110 V, for example, 5 V, 10 V, 50 V, 100 V, etc.

[0168] In some embodiments, the power module 111 may include multiple power submodules. Each of the multiple power submodules can provide power to multiple modules in the RF ablation host 110. For example, as shown in FIG4 , the power submodule 1111 can provide power to the output unit 1142, and the power submodule 1112 can provide power to the control module 113 and modules electrically connected to the control module 113 (e.g., the impedance detection unit 1151, the voltage and current feedback unit 1152, the information reading module 116, etc.).

[0169] It is understandable that by independently powering the modules corresponding to the power submodule through the power submodule, the power supply stability of the radiofrequency ablation host can be improved without generating mutual power supply interference.

[0170] In some embodiments, as shown in FIG. 4 , the RF ablation host 110 may further include a power filter 410 , a memory 420 , an audio device 430 , and a real-time clock 440 .

[0171] Power filter 410 is configured to suppress noise in the AC power supply, thereby transmitting the AC power supply to the power module without attenuation. It will be appreciated that the power filter can attenuate EMI noise introduced by the AC power supply while effectively suppressing EMI noise generated by power equipment, preventing it from entering the AC power grid and interfering with other electronic devices.

[0172] Memory 420 is configured to store data, instructions, and / or any other information. In some embodiments, the memory may store data and / or information obtained from at least one component of the ophthalmic radiofrequency ablation system or an external data source. For example, the memory may store ablation parameters and electrode information. For another example, the memory may store alternative output powers and alternative treatment times.

[0173] In some embodiments, memory 420 may include a large-capacity memory, a removable memory, or any combination thereof. Preferably, memory 420 may be an electrically erasable programmable read-only memory (EEPROM). By using EEPROM memory, data can be retained even after the device loses power or is shut down, preventing data loss. In some embodiments, memory 420 may be integrated into the control module 113 or other modules of the RF ablation host 110.

[0174] The audio device 430 can be configured to emit audio information. In some embodiments, the audio information can include audio-type warning information, prompts, etc. For example, when the control module 113 detects that the activation switch is abnormally started (i.e., it is started when the first preset condition is not met), the audio device 430 can be used to broadcast the warning message "Please release the activation switch" by voice. For another example, when the control module 113 detects that the ablation electrode is disconnected, a beeping prompt sound can be emitted through the audio device 430. In some embodiments, the audio device 430 can be integrated into the radiofrequency ablation host 110.

[0175] The real-time clock 440 is configured to provide time information to the RF ablation host 110. In some embodiments, the user can set the real-time clock through the input / output module when the RF ablation system is used for the first time. For example, the user can set the real-time clock in the display interface shown in Figure 26. In some embodiments, in response to the inaccurate time of the real-time clock 440, the control module 113 can remind the after-sales maintenance personnel to adjust the time. After-sales maintenance personnel or technicians can use engineering electrodes to set the time setting page shown in Figure 26. The engineering electrode is a type of ablation electrode, and the control module can determine whether it is an engineering electrode in a variety of ways. It is understandable that the RF ablation instrument can calculate the life of the ablation electrode based on the system time, and the RF ablation instrument does not include network time, so the time can only be set when it is turned on for the first time. The time setting authority for other situations is not open to the user.

[0176] FIG5 is a software / hardware diagram of a microcontroller unit according to some embodiments of the present specification.

[0177] In some embodiments, the microcontroller unit can be configured to have at least one of the following functions: pulse width modulation control, input / output, analog-to-digital conversion, read-only memory, random access memory, flash memory, timing, and serial communication. As shown in FIG5 , the microcontroller unit may include a processor 510, flash memory 520, read-only memory 530, random access memory 540, input / output port 550, communication port 560, analog-to-digital converter 570, and timer 580. These components may be connected via a bus to transmit information and implement related functions.

[0178] The processor 510 can be configured to process data from at least one component of the RF ablation host 110 (such as flash memory 520, read-only memory 530, random access memory 540, input / output port 550, communication port 560, analog-to-digital converter 570, and timer 580) or an external data source (for example, a cloud data center) to implement functions such as pulse width modulation control, human-computer interaction, initiation of ablation treatment, timing control, logic control (such as warnings when the activation switch or foot switch is abnormally activated, or when an error occurs in the self-test, prompts when the ablation electrode is unavailable, etc.) and calculation of RF voltage and current. Among them, pulse width modulation control refers to changing the pulse width to control the output power of the RF module. For example, the processor 510 can read the ablation parameters in the flash memory 520 and control the RF module to output RF energy based on the ablation parameters. For another example, the processor 510 can receive the impedance information of the eye tissue detected by the impedance detection module 115 through the input / output port 550, and determine whether the tip of the ablation electrode has reached the target position of the eye based on the impedance information, and / or convert the impedance information and display it on the display screen. For another example, the processor 510 can collect the operating status of the radiofrequency ablation host and / or its accessories (such as the foot switch, ablation electrode) through the communication port 560, determine the occurrence of a warning or error, and display it on the display screen or generate a prompt sound.

[0179] The flash memory 520 , the read-only memory 530 , and the random access memory 540 can store data. For example, the flash memory 520 can store ablation parameters set by the user.

[0180] The communication port 560 can perform serial communication, SPI communication, IIC communication, and the like.

[0181] The analog-to-digital converter 570 may be used to convert between analog signals and digital signals.

[0182] The timer 580 can perform signal timing capture, which refers to the timing acquisition of input signals, such as the timing acquisition of voltage and / or current information during the RF energy output process.

[0183] 6A and 6B are exemplary schematic diagrams of a radiofrequency ablation host structure according to some embodiments of the present specification.

[0184] In some embodiments, as shown in FIG6A , in addition to the aforementioned hardware modules (e.g., power module 111, RF module 112, control module 113, input / output module 114, impedance detection module 115, information reading module 116, etc.), power filter 410, memory 420, audio device 430, real-time clock 440, activation switch 450, and other structures, the RF ablation host 110 may also include a rotary handle 620, a cooling fan 630, a motherboard shielding cover 640, and related interfaces. The related interfaces include a connector socket 661, a power switch and interface 662, an equipotential interface 663, and a foot switch interface 664.

[0185] The rotating handle 620 can be mounted on the upper portion of the RF ablation main unit 110 and is used to hold the RF ablation main unit. In some embodiments, the rotating handle 620 can be provided with a handle protrusion so that when the rotating handle is lowered, it can slowly contact the handle groove at the corresponding position on the RF ablation main unit 110 to avoid colliding with the RF ablation main unit 110. In some embodiments, the rotating handle 620 can be connected to the RF ablation main unit 110 via a rotating shaft, and the rotating handle 620 can rotate along the rotating shaft (e.g., 0-180 degrees, 0-90 degrees, 0-160 degrees, etc.).

[0186] In some embodiments, the cooling fan 630 can be provided on both sides of the RF ablation host 110 to remove the heat generated by the RF ablation host 110. In some embodiments, the mainboard shielding cover 640 can be provided inside the shell of the RF ablation host 110 to shield the external electromagnetic interference to the inside of the RF ablation host or the inside of the RF ablation host to the outside. In some embodiments, the mainboard shielding cover 640 can be made of metal material to shield the interference while carrying the filter 410, the power module 111 and the cooling fan 630. A plurality of small holes are provided on one side of the shell of the RF ablation host 110 close to the cooling fan, and heat is discharged from the small holes to the outside of the RF ablation device 100. In some embodiments, a plurality of small holes (such as hole 670) are also provided on the other side of the RF ablation device 100 for transmitting the audio emitted by the audio device 430.

[0187] In some embodiments, the connector socket 661 can be provided on the side of the RF ablation host where the display screen is located (also referred to as the front), for connecting to the connector 130 to connect the ablation electrode 120 to the RF ablation host 110. By providing the connector interface on the side of the RF ablation host where the display screen is located, it is convenient for the user to view information displayed on the display screen (such as electrode information, treatment information, warning information, etc.) during the ablation process.

[0188] As shown in FIG6B , the power switch and interface 662 may be provided on the back of the RF ablation host (on the side opposite to the display screen) for connecting the RF ablation host 110 to an external power source.

[0189] As shown in FIG6B , the equipotential interface 663 can be provided on the back of the radiofrequency ablation host to enable the radiofrequency ablation host 110 to be grounded when there is no grounding socket, thereby ensuring the electrical safety of the ophthalmic radiofrequency ablation system.

[0190] As shown in FIG. 6B , the foot switch interface 664 may be provided on the back of the RF ablation host for connecting the foot switch to the RF ablation host 110 .

[0191] By arranging the power switch and interface 662, equipotential interface 663 and foot switch interface 664 on the back of the radiofrequency ablation host, the appearance of the host can be improved while ensuring use, while preventing the devices connected to the interface from affecting the user's viewing of the displayed information on the display screen.

[0192] In some embodiments, as shown in FIG6B , the RF ablation device 110 may further include a fixing structure 650 for fixing to the trolley 140. In some embodiments, the fixing structure 650 may be a structure that matches the locking member 240. For example, the fixing structure 650 may be a rectangular groove having the same shape as the locking member 240 and capable of accommodating the locking member 240. The locking member 240 rotates within the groove at a certain angle to achieve locking and fixation of the RF ablation device.

[0193] FIG. 7 is an exemplary schematic diagram of an ablation electrode according to some embodiments of the present specification.

[0194] In some embodiments, the ophthalmic radiofrequency ablation system 100 may include a radiofrequency ablation host 110 and accessories connected to the radiofrequency ablation host 110 , wherein the accessories include a foot switch and an ablation electrode 120 .

[0195] As shown in Figures 7 and 8A, in some embodiments, the ablation electrode 120 may include an electrode needle 1 with a tip 2 and an operating handle 4, with the electrode needle 1 mounted on the operating handle 4. The tip 2 is configured to penetrate ocular tissue to ablate the ocular tissue using radiofrequency energy. In some embodiments, the ablation electrode 120 may include an adjustment assembly 3 and an electrode needle protective cap 6.

[0196] The electrode needle 1 can be configured to generate ablation waves required for radiofrequency ablation. For example, after the ablation electrode 120 is connected to the radiofrequency ablation host 110, the electrode needle 1 can generate ablation waves using radiofrequency energy provided by the radiofrequency ablation host 110.

[0197] In some embodiments, as shown in FIG. 8A or FIG. 8B , the electrode needle 1 is cylindrical as a whole, and includes an inner electrode 21 , an outer electrode 23 , and an insulating structure. The insulating structure may include a first insulating layer 22 and a second insulating layer 24 .

[0198] In some embodiments, the cross-section of the columnar structure along the radial direction of the electrode needle is, from inside to outside, the electrode inner pole 21, the first insulating layer 22, the electrode outer pole 23, and the second insulating layer 24, and the central axis Z of the electrode inner pole 21, the first insulating layer 22, the electrode outer pole 23 and the second insulating layer 24 are in the same straight line.

[0199] In some embodiments, the outer diameter range of the electrode needle 1 may include 0.3~0.8mm, wherein the outer diameter range of the electrode inner pole 21 may include 0.1~0.4mm, the outer diameter range of the first insulating layer 22 may include 0.03~0.2mm, the outer diameter range of the electrode outer pole 23 may include 0.05~0.2mm, and the outer diameter range of the second insulating layer thickness 24 may include 0.03~0.2mm.

[0200] In some embodiments, the inner electrode can be made of tungsten, platinum, or a platinum-iridium alloy. The outer electrode can be made of stainless steel or a titanium alloy, such as 2Cr13, 1Cr13, or TC4. The insulating structure can be made of polyimide, polyetheretherketone, ceramic, parylene, PTFE, glass, ABS, PC, or POM.

[0201] In some embodiments, the tip 2 can be formed by grinding, and its length along the axial direction can range from 0.6 to 1.5 mm. The angle between the main line of the conical tip 2 and the central axis Z can range from 10 to 20°, preferably 12-16°. In this way, the tip 2 of the electrode needle can meet the strength requirements while being sharp enough, and will not curl or produce burrs due to being too sharp.

[0202] In some embodiments, when the ablation electrode 120 is connected to the radiofrequency ablation host 110 , an ablation wave is generated between the inner and outer regions of the ablation electrode 120 .

[0203] The operating handle 4 is configured to control the position of the ablation electrode. In some embodiments, as shown in Figures 7, 14, and 15, the operating handle 4 can be elongated and include a handle end 41 and a handle body 42. The handle end 41 and the handle body 42 can be detachably connected to facilitate replacement of the operating handle 42 with a different handle end 41. The detachable connection can include plug-in, snap-on, screw-on, and the like.

[0204] In some embodiments, the operating handle 4 may be made of ABS, PVC, PET, PA or other medical-grade polymer materials and engineering modified plastics.

[0205] In some embodiments, the handle end 41 may be tapered and circular in cross section. The diameter of the cross section at one end of the handle end is smaller than the diameter of the cross section at the other end, the end with the smaller cross section diameter being the front end of the handle end, and the end with the larger cross section diameter being the rear end of the handle end.

[0206] In some embodiments, a first annular flange 411 may be provided at a predetermined position between the front end and the rear end of the handle end 41. The predetermined position may include the middle portion of the handle end.

[0207] In some embodiments, the first annular flange 411 can form an abutment portion 412 with the rear side of the handle end. The abutment portion 412 can be used to abut the middle finger, preventing the finger from slipping when using the operating handle and improving the comfort of the hand holding the operating handle. In some embodiments, the cross-sectional diameter of the abutment portion can gradually decrease and then gradually increase along the direction from the first annular flange to the rear end of the handle end.

[0208] In some embodiments, a first through hole 43 may be provided at the front and rear ends of the handle end 41, and the electrode needle 1 is fixedly connected to the first through hole 43 by a permanent fixed connection (such as injection molding or gluing, etc.) or a non-permanent fixed connection (such as plug-in, snap-on, screw-on, etc. detachable connection).

[0209] In some embodiments, a positioning sleeve 413 may be provided inside the handle end 41. The positioning sleeve 413 coincides with the central axis of the handle end 41, and the free end of the positioning sleeve 413 extends further toward the rear side of the handle end 41. The handle end 41 is detachably connected to the handle body 42 via the positioning sleeve 413. For example, one of the positioning sleeve 413 and the handle body 42 may be provided with a first positioning groove 414, and the other of the positioning sleeve 413 and the handle body 42 may be provided with a positioning protrusion 421 that cooperates with the first positioning groove 414.

[0210] In some embodiments, the positioning sleeve 413 is circumferentially provided with a plurality of first positioning grooves 414, and the interior of the handle body 42 is correspondingly provided with a plurality of positioning protrusions 421 that cooperate with the first positioning grooves 414. The positioning protrusions 421 can be inserted into the first positioning grooves 414 to secure the handle end 41 to the handle body 42. Preferably, there can be two first positioning grooves 414, symmetrically arranged along the circumference of the positioning sleeve 413.

[0211] In some embodiments, a plurality of positioning protrusions may be provided around the positioning sleeve 413, and a plurality of first positioning grooves corresponding to the positioning protrusions may be provided inside the handle body 42. The positioning protrusions may be inserted into the first positioning grooves to fix the handle end 41 to the handle body 42.

[0212] In some embodiments, the interior of the positioning sleeve 413 may be provided with a counterweight cavity 45, into which a counterweight 46 is inserted. The provision of the counterweight 46 can enhance the user's operating feel. The counterweight 46 is tubular in structure and is circumferentially provided with a plurality of second positioning grooves 47 corresponding to the first positioning grooves 414. The positioning protrusion 421, after being inserted through the first positioning grooves 414, is further inserted into the second positioning grooves 47. This strengthens the fixed connection between the handle end 41 and the handle body 42, while also preventing the counterweight 46 from escaping from the counterweight cavity 45.

[0213] In some embodiments, as shown in FIG15 , the length of the electrode inner pole 11 in its axial direction can be greater than the lengths of the first insulating layer 12, the electrode outer pole 13, and the second insulating layer 14. The end of the electrode inner pole 11 away from the needle tip 2 (i.e., the end inside the operating handle 4) is electrically connected to the memory chip 5 inside the operating handle 4 via a connecting wire or a metal connecting tube 36 sleeved on the electrode inner pole 11. The second insulating layer 14 is partially peeled off at the end of the electrode needle 1 located inside the operating handle 4, exposing the electrode outer pole 13, which is electrically connected to the memory chip 5 via a connecting wire. The connecting wire and the memory chip 5 can be electrically connected by welding, such as micro-resistance welding, laser welding, brazing, etc.

[0214] In some embodiments, the handle body 42 may be in the shape of a slender arc, with one end connected to the rear end of the handle end being the front end of the handle body, and the other end being the rear end of the handle body.

[0215] In some embodiments, the front end of the handle body may be provided with a second annular flange 422, forming a grip portion 423 between the second annular flange 422 and the rear end of the handle body 42. The grip portion 423 has a circular cross-section, and its cross-sectional dimensions gradually decrease and then increase from the second annular flange 422 to the rear end of the handle body 42. The grip portion 423 can be gripped by the thumb and index finger of the hand, thereby improving the comfort of the hand holding the operating handle.

[0216] In some embodiments, the handle body 42 may include a left housing 8, a right housing 9, and an upper housing 7. In some embodiments, the left housing 8 and the right housing 9 may have identical and symmetrical structures and be detachably connected. In some embodiments, the upper housing 7 may be inserted into the opening formed by the left housing 8 and the right housing 9.

[0217] In some embodiments, as shown in Figures 14 and 17 , the top middle regions of the left and right housings 8, 9 may each be provided with an opening 75 to allow the upper housing 7 to be inserted into a mounting groove 76 formed by the two openings 75. Preferably, the openings 75 may be arc-shaped so that the shape of the openings 75 better matches the cross-sectional variation of the handle body 42.

[0218] In some embodiments, a first fixing block 71 may be provided at the bottom of the upper shell 7 near the front end, and a first fixing slot 77 may be provided on the lower side of the front end of each opening 75. The first fixing block 71 can be inserted and fixed in the first fixing hole 78 formed by the two first fixing slots 77, that is, the front end of the upper shell 7 can be engaged in the first fixing hole 78 through the first fixing block 71.

[0219] In some embodiments, plug-in card blocks 72 may be provided on both sides of the middle area of ​​the bottom of the upper shell 7, and a plug-in card slot 79 that cooperates with the plug-in card block 72 may be provided on the lower side of the middle part of the opening 75. The two ends of the upper shell 7 can be respectively plugged into the plug-in card slots 79 in the left shell 8 and the right shell 9 through the plug-in card block 72.

[0220] In some embodiments, a second fixing block 81 may be provided at the bottom of the upper shell 7 near the rear end, and a second fixing slot 70 may be provided on the lower side of the rear end of each opening 75. The second fixing block 81 can be inserted and fixed in the second fixing hole 82 formed by the two second fixing slots 70, that is, the rear end of the upper shell 7 can be engaged in the second fixing hole 82 through the second fixing block 81.

[0221] In some embodiments, a mounting bump 73 may be provided in the middle area of ​​the bottom of the upper housing 7. The mounting bump 73 is integrally formed with the plug-in card blocks 72 on either side. The lower surface of the mounting bump 73 may be provided with a mounting cavity 74 extending toward its upper surface to allow the memory chip 5 to be accommodated and fixed in the mounting cavity 74.

[0222] In some embodiments, a threading hole 83 may be provided at the rear end of the upper housing 7 , and the threading hole 83 may allow a signal cable connected to the electrode needle 1 or the memory chip 5 to pass through.

[0223] The adjustment component 3 is configured to be inserted into the outer surface of the electrode needle 1 and can move axially relative to the electrode needle 1 to adjust the length of the electrode needle 1 exposed from the adjustment component 3. In some embodiments, the adjustment component may include an adjustment tube 3.

[0224] In some embodiments, the inner diameter of the adjustment tube 3 is larger than the outer diameter of the electrode needle 1, and a protruding step can be formed between the electrode needle 1 and the adjustment tube 3. When the tip of the electrode needle penetrates the eye tissue, the protruding step can contact the eye surface, preventing the adjustment tube from penetrating the eye tissue.

[0225] It is understood that the length of the electrode needle 1 exposed outside the adjustment tube 3 is the depth of penetration of the electrode needle 1 into the eye tissue. In some embodiments, the depth of penetration of the electrode needle into the eye tissue can range from 0.5mm to 2.5mm. For example, 0.5mm, 0.7mm, 1.1mm, 1.5mm, 2.5mm, etc. The depth of penetration of the electrode needle into the eye tissue can be determined based on the actual use.

[0226] In some embodiments, the adjustment tube 3 may include multiple adjustment tubes of different lengths. Different adjustment tube lengths result in different lengths of the electrode needle exposed from the adjustment tube. For example, if the depth of the electrode needle penetrating the eye tissue changes from 1.5 mm to 2.5 mm, a 1 mm shorter adjustment tube may be required compared to the previously used adjustment tube.

[0227] In some embodiments, the adjustment tube 3 can be mounted on the adjustment handle 4 in a variety of ways. For example, the adjustment tube can be fixed to the operating handle by magnetic attraction. For example, the adjustment tube can be fixed to the operating handle by plugging.

[0228] In some embodiments, as shown in FIG9A or 9B , a numerical mark 31 is provided on the outer surface of one end of the adjustment tube, and a position mark 32 is provided on the outer surface of the other end. The numerical mark 31 may indicate the length of the electrode needle exposed from the adjustment tube. For example, a numerical mark of 2.5 mm indicates that the electrode needle is 2.5 mm exposed from the adjustment tube. The position mark 32 may indicate that the adjustment tube has been inserted into a position where it can be securely connected to the operating handle.

[0229] In some embodiments, the in-position mark 32 may include a color area 321 or a color ring 322 provided on the surface of the adjusting tube. When the color area 321 or the color ring 322 is completely covered by the operating handle, it indicates that the adjusting tube is inserted into a position where it can be fixedly connected to the operating handle.

[0230] The electrode needle protection cap 6 is configured to protect the electrode needle. In some embodiments, as shown in FIG16 , the electrode needle protection cap 6 can be a hollow conical structure, covering and fixed to the periphery of the handle end 41 .

[0231] In some embodiments, the electrode needle protection cap 6 may be provided with a second through hole 61, which connects the front and rear opposite sides of the electrode needle protection cap 6 to allow the adjustment tube 3 to pass through the second through hole 61. The electrode needle protection cap 6 is provided with a strip-shaped through hole 62 extending axially and penetrating the electrode needle protection cap 6 in the radial direction of the electrode needle protection cap 6.

[0232] In some embodiments, a preset number of strip-shaped clamping arms 63 may be formed in the strip-shaped through hole 62. The free end of each strip-shaped clamping arm 63 extends toward the second through hole 61. The strip-shaped clamping arm 63 can clamp the adjustment tube 3 after elastic deformation. The preset number may include two.

[0233] In some embodiments, the strip-shaped clamping arms 63 can be arranged symmetrically with each other, and the two strip-shaped clamping arms 63 are provided with protruding clamping portions 631 on the inner sides facing each other, and the clamping surfaces of the clamping portions 631 respectively have semicircular grooves (not shown). When the adjusting tube 3 passes through the second through hole 61, the grooves on the inner surfaces of the clamping portions 631 form a guide channel, and the guide channel of the clamping portion 631 guides the adjusting tube 3 to align and enter the first through hole 43.

[0234] In some embodiments, the regulating tube 3 can be inserted with the help of the electrode needle protective cap 6. The specific steps for installing the regulating tube 3 are as follows: the operator selects the required model of regulating tube 3, inserts the selected regulating tube 3 from the second through hole 61 of the electrode needle protective cap 6, and presses multiple strip clamping arms 63 at the same time to tighten the regulating tube 3 centrally, and forms a guide channel to guide the regulating tube 3 to align with the first through hole 43 of the insertion operating handle 4, thereby realizing rapid insertion of the regulating tube 3.

[0235] In some embodiments, the adjustment tube 3 of different lengths can be freely replaced with the help of the electrode needle protective cap 6, which plays a good guiding role in replacing the adjustment tube 3, facilitates the rapid insertion of the adjustment tube 3 into the operating handle 4, and can quickly obtain the required depth of the electrode needle 1 inserted into the eye.

[0236] In some embodiments, the ablation electrode 120 may include three or more electrode needles, wherein one of the three or more electrode needles serves as an inner electrode pole located at the center of the ablation electrode 120, and the remaining electrode needles serve as outer electrode poles disposed around the one electrode needle, with an insulating structure disposed between the inner electrode pole and the outer electrode pole.

[0237] Please refer to Figure 10, which illustrates an example of an ablation electrode comprising three or more electrode needles. As shown in Figure 10, taking a case comprising five electrode needles as an example, the front end of the ablation electrode 120 has a conical structure. An inner electrode pole 1021 may be positioned at the tip of the cone. Four outer electrode poles 1023 are positioned around the inner electrode pole 1021 on the conical surface of the cone. The remaining portion between the inner electrode pole 1021 and the four outer electrode poles 1023 is a cast insulating structure. It should be understood that Figure 10 is merely an example. In some embodiments, any number of outer electrode poles, such as three, five, six, or seven, may be positioned around the inner electrode pole 1021. In some embodiments, the multiple outer electrode poles may form a regular or irregular shape, such as a triangle, quadrilateral, or pentagon, in the cross-section of the ablation electrode. In some embodiments, the inner electrode pole 1021 may be located at a non-central position among the multiple outer electrode poles, such as near the left or right side. In some embodiments, the insulating structure may be constructed of the same material as that used in the electrode needle 1 shown in Figure 8A.

[0238] In some embodiments, the tip of the ablation electrode 120 shown in FIG10 can be formed by grinding. During the grinding process, the tip of the tapered needle tip is formed from the inner electrode 1021, and the outer electrode 1023 on the conical surface is exposed during grinding. In some embodiments, the diameter of the inner electrode and the outer electrode of the ablation electrode 120 shown in FIG10 can range from 0.1 to 0.3 mm, and the overall size of each electrode needle can be the same as the electrode needle 1 described above.

[0239] In some embodiments, the ablation electrode 120 may include an even number of electrode needles, half of which are positive electrodes and the other half are negative electrodes, and the positive electrodes and negative electrodes are alternately arranged, and an insulating structure is arranged on the periphery of each electrode needle.

[0240] Please refer to Figure 11, which shows a schematic diagram of an ablation electrode comprising an even number of electrode needles. As shown in Figure 11, the ablation electrode 120 can be composed of an even number of electrode needles (such as 4, 6, 8, 10, etc.), with half of the electrode needles being positive electrodes 11-1 and the other half being negative electrodes 11-2. The negative electrodes 11-2 and the positive electrodes 11-1 can be arranged alternately, and an insulating structure can be provided around the periphery of each electrode needle.

[0241] In some embodiments, an even number of electrode needles can be arranged in a circular, triangular, polygonal or other structure. Preferably, an even number of electrode needles can be arranged in an arc shape (such as a half arc, two-thirds arc, three-quarters arc, etc.) and inserted into the operating handle. The arc-shaped electrode needles can better adapt to the shape of the eye tissue. It is worth noting that the structure of the operating handle or shell of the ablation electrode shown in Figure 11 may be different from the structure of the operating handle shown in Figure 7. When the ablation electrode is connected to the radiofrequency ablation host and radiofrequency energy is output, an ablation zone can be formed between two adjacent electrode needles, thereby generating an ablation wave. Among them, the spacing range of the spaced electrode needles may include 0.3-0.9mm.

[0242] In some embodiments, the size range and constituent materials of the even-numbered electrode needles in the ablation electrode 120 shown in Figure 11 may be the same as those of the electrode needle 1. In some embodiments, the even-numbered electrode needles may be arranged in multiple rows.

[0243] In some embodiments, the ablation electrode 120 may include an electrode needle, wherein the electrode inner pole, the insulating structure and the electrode outer pole of the electrode needle are stepped at the tip of the electrode needle along the axial direction of the ablation electrode.

[0244] Please refer to Figures 12A and 12B, which show an ablation electrode with a step-shaped electrode needle. As shown in Figures 12A and 12B, the ablation electrode 120 includes an electrode needle 12, the center of the electrode needle 12 is an electrode inner pole 1221, an insulating structure 1222 is provided on the periphery of the electrode inner pole 1221, and an electrode outer pole 1223 is sleeved outside the insulating structure 1222, and the electrode inner pole 1221, the insulating structure 1222 and the electrode outer pole 1223 form a step-like structure at the tip of the electrode needle 12 along the axial direction of the electrode needle. In some embodiments, an insulating structure transition portion may be provided between the electrode inner pole 1221 and the insulating structure 1222 to avoid the formation of steps that make it difficult for the electrode needle to penetrate the eye tissue. The outer diameter of the insulating structure 1222 is 0.3-0.8 mm. In some embodiments, the electrode needle 12 may be a non-cylindrical structure.

[0245] As shown in Figure 12A, in some embodiments, the electrode outer pole 1223 can form a boss 1224 protruding from the outer surface of the electrode outer pole 1523 along the radial direction of the electrode needle at the connection between the tip of the electrode needle 12 and the insulating structure 1222. The boss 1224 can be disc-shaped and attached to the patient's ocular surface during ablation. In some embodiments, the boss 1223 can be any shape such as a cuboid, a cube, a cylinder, an irregular body, etc. In some embodiments, the thickness of the boss 1224 (i.e., the length along the axial direction of the electrode needle) can be in the range of 0.1-0.3 mm. In some embodiments, the axial distance from the end of the tip of the electrode needle 12 to the lower surface of the boss can be in the range of 0.5-1.8 mm.

[0246] As shown in FIG. 12B , in some embodiments, the electrode needle 12 may not be provided with the boss 1224 , that is, the annular table formed between the electrode outer pole 1223 and the insulating structure 1222 directly contacts the ocular surface.

[0247] In some embodiments, the electrode needle 12 may only include an inner electrode and an insulating structure around the inner electrode, and the outer electrode is attached to the periphery of the eye to be radiofrequency ablated in the form of a patch.

[0248] In some embodiments, the ablation electrode 120 may include a sandwich electrode needle 13. The sandwich electrode needle 13 includes a positive electrode, a negative electrode, and an insulating layer disposed radially therebetween. The insulating layer forms the tip of the electrode needle. In some embodiments, the sandwich electrode needle 13 may be a special-shaped electrode needle or a regular cylindrical electrode needle with a tapered tip.

[0249] Please refer to Figure 13, which shows ablation electrodes stacked along the radial direction of the ablation electrode. As shown in Figure 13, the electrode needle 13 can have a non-cylindrical structure and a non-conical tip. In some embodiments, the electrode needle 13 can include a first pole 1311, a second pole 1312, and an insulating interlayer 1313 (i.e., an insulating structure) disposed between the first and second poles along the radial direction. The first pole 1311 and the second pole 1312 are the positive and negative poles, respectively. For example, the first pole 1311 is the positive pole and the second pole is the negative pole; or the first pole is the negative pole and the second pole is the positive pole. In some embodiments, the first pole 1311, the second pole 1312, and the insulating interlayer 1313 can form a hexagonal structure in the cross-section of the electrode needle 13. In some embodiments, the thickness of the insulating interlayer 1313 (the length along the radial direction of the electrode needle) can be in the range of 0.1-0.3 mm. In some embodiments, the length of the tip of the electrode needle 13 along its axial direction can be in the range of 0.3-1.5 mm.

[0250] In some embodiments, the insulating structure may be made of glass, ceramic, basalt, etc. The first electrode and the second electrode may be made of the same material as the electrode needle 1 described above.

[0251] In some embodiments, the electrode needles 1, 11, 12, and 13 can be formed into insulating structures or insulating structures and outer electrode poles in a variety of ways. For example, the electrode needles can be formed into insulating structures or insulating structures and outer electrode poles by coating, and the electrode tips can be formed by grinding. For example, the electrode needles can be formed into insulating structures and metal outer electrode poles on the needle tip surface of the inner electrode pole by vapor deposition and electroplating respectively; in addition, it should be understood that the outer electrode pole and the inner electrode pole in this specification serve as the positive pole and the negative pole respectively during the radiofrequency ablation process, that is, when the inner pole is the positive pole, the outer pole will be the negative pole, or when the inner pole is the negative pole, the outer pole will be the positive pole.

[0252] As mentioned above, the radiofrequency ablation system of the present invention can achieve radiofrequency ablation of eye tissues such as the ciliary body, trabecular meshwork, iris and sclera. For different eye tissues, in order to facilitate the operation of ablation, the morphological structure of the electrode needle can be designed differently. For example, the end of the electrode needle that penetrates the eye tissue is a straight needle, a curved needle with a straight tip, or a curved needle with a curved tip. For example, in some embodiments, the electrode is used to ablate the ciliary body, and its electrode needle 1 is in the form of a straight needle. In some embodiments, the electrode is used to ablate the trabecular meshwork, and its electrode needle is in the form of a curved needle with a straight tip.

[0253] In some embodiments of this specification, the ophthalmic radiofrequency ablation system can complete radiofrequency ablation operations more safely and conveniently, and can recommend corresponding treatment plans based on different treatment sites, and can achieve precise radiofrequency ablation of eye tissues such as the ciliary body, trabecular meshwork and iris.

[0254] It should be understood that the ophthalmic radiofrequency ablation system and its modules shown in FIG1 can be implemented in various ways. It should be noted that the above description of the ophthalmic radiofrequency ablation system and its modules is for convenience of description only and does not limit this specification to the scope of the embodiments cited. It is understandable that for those skilled in the art, after understanding the principle of the system, it is possible to arbitrarily combine the various modules, or form a subsystem to connect with other modules without deviating from this principle. In some embodiments, the control module, radio frequency module, input / output module, impedance detection module and information reading module disclosed in FIG1 can be different modules in a system, or a module can realize the functions of two or more of the above modules. For example, each module can share a storage module, or each module can have its own storage module. Such variations are all within the scope of protection of this specification.

[0255] FIG18 is an exemplary flow chart of an ophthalmic radiofrequency ablation method according to some embodiments of this specification. FIG19 is an exemplary schematic diagram of an embodiment of an ophthalmic radiofrequency ablation method according to some embodiments of this specification. As shown in FIG18 , process 1800 may include the following steps:

[0256] Step 1810 : In response to the radiofrequency ablation device being turned on, detecting whether the radiofrequency ablation device functions normally.

[0257] Powering on the system can refer to activating the RF ablation system via a keystroke or other means (e.g., voice command). In some embodiments, as shown in FIG19 , prior to powering on the system, pre-power-on preparations can be performed, such as connecting the power supply and the foot switch. In some embodiments, after powering on, the system can automatically detect whether all functions of the RF ablation system are functioning normally.

[0258] In some embodiments, detecting whether the function of the RF ablation device is normal may include at least one of the following: detecting whether the foot switch and / or activation switch is abnormally started, detecting whether the status of the analog-to-digital converter of the RF ablation host is normal, detecting whether the RF output frequency is normal, detecting whether the clock of the RF ablation host is accurate, detecting whether the serial port communication of the RF ablation host is normal, detecting whether the power supply is normal, and detecting whether the reading and writing of the memory of the RF ablation host is normal, etc.

[0259] In some embodiments, in response to a module in the radiofrequency ablation host failing to operate properly, an interactive interface 2000 may be entered, and a prompt message may be displayed. The prompt message may include an error code. The error code may indicate different errors detected. For example, E01-12V indicates a detection error, E04-DAC indicates an output abnormality, etc.

[0260] As shown in FIG25 , in some embodiments, in response to the RF ablation system being powered on and all modules functioning normally, the interactive interface 2000 may display a system settings page, including settings for turning on / off the touch button prompt tone, adjusting screen brightness, and setting the system time. The touch button prompt tone can be selected by touching the on / off selection button. The screen brightness can be selected by sliding the nodes on the right line. The system time can be set using the input box shown in FIG21 , for example, to 11:19 on October 8, 2023.

[0261] As shown in Figure 26, in some embodiments, in response to the first use of the radiofrequency ablation system, the interactive interface 2000 can display a time setting interface 600. The user cannot set the system time at other times. If the system time needs to be set, the after-sales technician can use the engineering electrode to set it in the engineering interface. The engineering interface includes year, month, day, hour, minute, week and a confirmation button. Among them, enter the correct year, month, day, hour, minute and week in the input boxes corresponding to the year, month, day, hour, minute and week, and touch the confirmation button to complete the time reset. In some other embodiments, in the engineering interface, the after-sales technician can also correct some of the electrode information (such as when the information is incorrect), rewrite it, or perform other background settings.

[0262] It is understandable that the radiofrequency ablation system can calculate the life of the ablation electrode based on the system time, and the radiofrequency ablation system does not include network time, so the time setting permission is not open to the user.

[0263] In some embodiments, the radiofrequency ablation system can be networked. One or more components of the radiofrequency ablation system (e.g., the control device 210, the radiofrequency generator 220, the impedance detection device 230, the information reading unit 240) can communicate information and / or data with one or more other systems of the radiofrequency ablation system (e.g., a medical management system) via a network. For example, the control device 210 can obtain data (e.g., a patient's electronic medical record) from other systems via a network. The network can be any suitable network for the exchange of information and / or data. The network can be and / or include a public network (e.g., the Internet), a private network (e.g., a local area network (LAN), a wide area network (WAN)), a wired network (e.g., a wireless local area network), Ethernet, a wireless network (e.g., an 11 network, a Wi-Fi network), etc.

[0264] In some embodiments, when the radiofrequency ablation system is connected to the network during use, it can automatically obtain the real-time network time and use the real-time network time as the real-time clock device's real-time time. In this case, the user does not need to set the real-time clock device.

[0265] A medical management system refers to a system used by a hospital to manage or process all aspects of medical information. For example, a medical management system may include outpatient and emergency management systems, medical record management systems, and medical statistical query systems. In some embodiments, after the radiofrequency ablation system is connected to the medical management system network, it can have patient management functions. For example, the radiofrequency ablation system is connected to a camera, which scans a code to input patient information; by retrieving more patient information from the medical management system (such as medical records and appointment times), the patient can be managed. In some embodiments, patient management functions also include data analysis, developing patient review plans, and reminding patients to review.

[0266] In some embodiments, the radiofrequency ablation system can obtain treatment information of different patients (such as the duration of a single radiofrequency treatment, the total duration of treatment, the output power of radiofrequency energy, etc.) based on a medical management system or an Internet platform; and perform big data analysis based on the treatment information of different patients. In some embodiments, the radiofrequency ablation device can recommend ablation parameters based on the results of the big data analysis. For example, the radiofrequency ablation device can input the characteristics of the current patient into the big data model of the medical management system based on the personal characteristics and disease condition of the current patient, and the big data model outputs the corresponding recommended ablation parameters (treatment time, output power of radiofrequency energy, etc.).

[0267] In some embodiments, when all modules of the RF ablation host are functioning normally, the RF energy control switch of the RF ablation system can be tested for proper function. In some embodiments, the RF energy control switch can include an activation switch and / or a foot switch. In some embodiments, in response to detecting that the RF energy control switch of the RF ablation system is not functioning properly, the interactive interface 2000 can display a warning message. The warning message can include, for example, "Please release the activation switch," "Foot switch not connected," or "Please release the foot switch." For more information on the warning message, see FIG. 1 and its related description. In some embodiments, when the RF ablation system is powered on and no ablation electrodes are connected, if the user activates the foot switch or activation switch, and a warning message (such as "Please release the foot switch" or "Please release the activation switch") appears on the interactive interface 2000, the RF energy control switch of the RF ablation system can be considered to be functioning properly. For example, if the user activates the activation switch when the first preset condition is not met, and a warning message (such as "Please release the activation switch") appears on the interactive interface 2000, the RF ablation system's activation switch can be considered to be functioning properly. For another example, when the second preset condition is not met, the user activates the foot switch. If a warning message (such as "Please release the foot switch") appears on the interactive interface 2000, it can be considered that the foot switch of the radiofrequency ablation system is functioning normally.

[0268] Step 1820 : In response to all functions of the radiofrequency ablation system being normal, it is detected whether the ablation electrode connected to the radiofrequency ablation host is available.

[0269] In some embodiments, the information reading module can obtain electrode information of the ablation electrode and transmit the electrode information to the control module. For more information about the electrode information, the information reading module, and the control module, please refer to FIG1 and its related descriptions, which will not be repeated here.

[0270] In some embodiments, the electrode information of the ablation electrode can be obtained when the ablation electrode is connected to the radiofrequency ablation host.

[0271] In some embodiments, the radiofrequency ablation system may determine the availability of the ablation electrode based on the electrode information.

[0272] In some embodiments, as shown in FIG20 , in response to the ablation electrode being unavailable, the interactive interface 2000 may display an electrode replacement display page to remind the user to replace the ablation electrode. For instructions on determining the availability of the ablation electrode, see FIG3 and its related description.

[0273] In step 1830, in response to the ablation electrode being available and the state of the radiofrequency ablation system meeting a preset condition, ablation is performed on the eye tissue based on ablation parameters. For the determination of ablation parameters, please refer to FIG. 1 and its related description.

[0274] In some embodiments, as shown in FIG22 , in response to the ablation electrode being available, the interactive interface 2000 may display a confirmation page for electrode identification after the ablation electrode is electrically connected, including whether the ablation electrode is connected and electrode life information. When the ablation electrode is connected, the electrode icon is highlighted, and when the ablation electrode is not connected, the electrode icon is dimmed. If the user confirms that the electrode information is correct, they can confirm it by clicking the confirmation button in the figure; if the user believes that the electrode information is incorrect, they can replace the connected ablation electrode or request after-sales maintenance personnel to handle it. After-sales maintenance personnel can correct and rewrite the erroneous information stored in the electrode.

[0275] In some embodiments, in response to the ablation electrode being available and the electrode information being confirmed, the parameter setting interface 700 (page shown in FIG. 23 ) may be entered. In some embodiments, as shown in FIG. 23 , the parameter setting interface may include accessory connection status, treatment time, RF power, and electrode life information. Among them, the accessory connection status may include an electrode icon and a foot switch icon, and the electrode icon includes an electrode type and an electrode legend. The treatment time may include time information, and the time information includes the treatment time duration and a time adjustment button. The RF power may include power information, and the power information includes the RF power duration and a power adjustment button. The electrode life information may include the number of times used, the number of remaining uses, or the cumulative ablation time, and the remaining ablation time. For information about treatment time, RF power, the number of times used, the number of remaining uses, the cumulative ablation time, and the remaining ablation time, please refer to FIG. 1 and its related description.

[0276] In some embodiments, in response to the ablation electrode not being connected, the electrode icon can be displayed in gray, and in response to the foot switch not being connected, the foot switch icon can be displayed in gray. Even when the accessories (ablation electrode and foot switch) are not connected, the system will enter the treatment parameter setting page shown in Figure 23. Based on this, the demonstration and teaching of the radiofrequency ablation system can be facilitated when the accessories are not connected.

[0277] In some embodiments, in response to the ablation electrode being available and the user confirming the electrode information, the control module may determine recommended parameters according to the electrode type of the ablation electrode, and determine target parameters based on user input information regarding the recommended parameters.

[0278] Recommended parameters refer to recommended ablation parameters (such as alternative treatment time, alternative radiofrequency power). Target parameters refer to determined ablation parameters. In some embodiments, the recommended parameters may include parameter values ​​or parameter ranges of recommended ablation parameters, and the input information may include user adjustment information or confirmation information for the recommended parameter values, or target parameters input by the user based on the recommended parameter range. In response to receiving the user's confirmation information, the control module may determine the parameter value corresponding to the confirmation information as the target parameter.

[0279] Exemplarily, in response to the ablation electrode being available and confirmed by the user, the control module can recommend the parameter value or parameter range of the ablation parameter based on the electrode type of the ablation electrode and control the input / output module to display it on the interactive interface for the user to adjust the parameter value and confirm or input the parameter within the recommended parameter range, and use the confirmed parameter value as the determined target parameter, or use the parameter within the recommended parameter range as the confirmed target parameter.

[0280] In some embodiments, when the ablation electrode is available, before or after the electrode information is confirmed, it is possible to detect whether the foot switch is connected. If it is not connected, a prompt message "Foot switch not connected" is output in the interactive interface. At this time, the user can proceed to the next step by clicking the "Confirm" button in the interface or connecting the foot switch, such as entering the electrode identification confirmation page shown in Figure 22 or the parameter setting page shown in Figure 23. It is worth noting that the connection order of the foot switch and the ablation electrode is not restricted. In some embodiments, it is possible to first detect whether the foot switch is connected and then detect whether the ablation electrode is connected, or to detect whether the foot switch and the ablation electrode are connected at the same time, or to first detect whether the ablation electrode is connected and then detect whether the foot switch is connected. In some embodiments, if the foot switch is connected, the activation status of the foot switch can be monitored in real time. In some embodiments, as shown in Figure 21, in response to the second preset condition not being met to activate the foot switch, the interactive interface 2000 can display a warning message "Please release the foot switch".

[0281] In some embodiments, in response to the first preset condition not being met, the activation switch is activated and the interactive interface 2000 may display “Please release the activation switch.” For an explanation of the first and second preset conditions, see FIG. 1 and its related description.

[0282] In some embodiments, as shown in FIG19 , if the ablation electrode is available and the status of the RF ablation system meets preset conditions (such as the user confirms the electrode information, the ablation parameters have been determined, the foot switch is connected, and there are no other errors in the RF ablation system), in response to the activation switch being started, the control module can determine whether the tip of the ablation electrode has reached the target position of the eye based on the impedance information obtained by the impedance detection module. If the tip of the ablation electrode has reached the target position of the eye, in response to the foot switch being started, the RF ablation host can output RF energy.

[0283] In some embodiments, as shown in FIG24 , in response to treatment initiation, the interactive interface 2000 may display a treatment initiation information display page, which may include, for example, electrode status, treatment time, RF power, elapsed treatment time, real-time impedance, electrode life information, etc. For details on elapsed treatment time and real-time impedance, see FIG1 and its related description.

[0284] The electrode status may include electrode information, which may be used to indicate whether the ablation electrode is outputting radiofrequency energy. The electrode lifespan information may include the number of uses, the number of remaining uses, or the cumulative ablation time and the remaining ablation time.

[0285] In some embodiments, as shown in FIG19 , during the ablation of ocular tissue, in response to a sudden change in impedance, the release of a foot switch, or the treatment time reaching a preset time threshold, the RF ablation host can stop the output of RF energy. It is understandable that after the RF treatment is completed, the impedance of the ocular tissue will suddenly change, and the impedance sudden change can indicate the completion of the RF treatment. Specifically, the threshold of the sudden change can be determined according to different target tissues, such as setting the threshold to an impedance greater than a certain value. Alternatively, the sudden change in impedance can also be judged by the change in the impedance change (difference) collected multiple times, for example, the impedance change approaches zero to form an inflection point, or the impedance change increment exceeds a preset value.

[0286] In some embodiments, as shown in FIG19 , in response to the ocular tissue not needing further treatment, the user releases the activation switch, and the RF treatment process ends. In some embodiments, in response to an abnormality occurring during the output of RF energy, the user presses the activation switch, and the RF ablation host can stop outputting RF energy.

[0287] In some embodiments, in response to the end of the RF treatment process, the RF ablation host can write the usage information of the ablation electrode (such as the number of times it has been used, the number of remaining uses, or the cumulative ablation time, the remaining ablation time) back to the storage chip of the ablation electrode.

[0288] The ophthalmic radiofrequency ablation system described in this manual can achieve multiple uses: Based on the thermal effect of radiofrequency ablation, when this ophthalmic radiofrequency ablation device is used to perform radiofrequency ablation on the ciliary body, the ciliary body tissue will be damaged or partially necrotic, inhibiting its ability to produce aqueous humor, thereby reducing intraocular pressure (IOP) to treat glaucoma; in addition, radiofrequency ablation can also cause the ciliary body to shrink due to heat, which can deepen the anterior chamber, treat shallow anterior chamber syndrome, and prevent angle-closure glaucoma; at the same time, ciliary body contraction also increases the gap between the choroid and sclera (the suprachoroidal space), producing a suprachoroidal drainage effect. Alternatively, this radiofrequency ablation device can be used to perform radiofrequency ablation of the trabecular meshwork by replacing the appropriate electrode needle shape, creating ablation holes circumferentially in the trabecular meshwork, allowing aqueous humor in the anterior chamber to flow through the ablation holes in the trabecular meshwork into the Schlemm's canal to treat early and mid-stage open-angle glaucoma. Furthermore, for iris radiofrequency ablation, this radiofrequency ablation device can be used to perform radiofrequency ablation drilling on the iris by replacing the appropriate electrode needle configuration, thereby connecting the anterior and posterior chambers and achieving the effect of iridotomy. Alternatively, replacing the appropriate electrode needle can also be used to ablate the sclera, creating an ablation tunnel from the anterior chamber angle to the sclera through ablation, achieving subconjunctival drainage. Furthermore, the radiofrequency ablation system described in this specification can also be used to stop bleeding on the ocular surface or within the eye.

[0289] On the other hand, the present application also claims protection for a radiofrequency ablation device 110 (also referred to as a radiofrequency ablation host) in the aforementioned radiofrequency ablation system. For the relevant introduction and description of the radiofrequency ablation device 110, please understand it in conjunction with the previous relevant introduction and the description below.

[0290] In some embodiments, as shown in FIG1 , a radiofrequency ablation device 110 can be used to provide radiofrequency energy to an ablation electrode 120 connected thereto to ablate target tissue in an eye 1300 . The target tissue refers to the tissue site to be ablated. For example, the target tissue may include the ciliary body, trabecular meshwork, or iris of the eye.

[0291] In some embodiments, when the ablation electrode 120 is connected to the radiofrequency ablation device 110, the radiofrequency ablation device 110 provides radiofrequency energy to the ablation electrode 120, and the radiofrequency energy is transmitted to the target tissue through the ablation electrode 120, thereby achieving the purpose of ablation of the target tissue. In some embodiments, the ablation electrode 120 may include an electrode needle with a tip, and the tip is configured to penetrate the target tissue. The electrode needle may include an outer pole and an inner pole, and one of the outer pole and the inner pole serves as a positive pole and a negative pole respectively under the radiofrequency energy provided by the radiofrequency ablation device, and an ablation wave is formed between the positive pole and the negative pole, thereby achieving ablation of the target tissue.

[0292] In some embodiments, when the ablation electrode 120 is connected to the radiofrequency ablation device 110 for the first time, the radiofrequency ablation device 110 may actively write the time of the electrode's first use into a memory chip of the ablation electrode 120 .

[0293] In some embodiments, each time the ablation electrode is connected to the RF ablation device 110, the RF ablation device 110 can actively update usage information such as the remaining number of electrode uses and the number of times the electrode has been used (or the accumulated ablation time and the remaining ablation time) and write it into the storage chip of the ablation electrode 120.

[0294] In some embodiments, in response to the end of ablation, the RF ablation device 110 can update the electrode information (such as the remaining number of times the electrode can be used, the number of times it has been used, or the cumulative ablation time and the remaining ablation time, etc.), and / or actively write the electrode information stored in the RF ablation device (such as the remaining number of times the electrode can be used, the number of times it has been used, or the cumulative ablation time and the remaining ablation time, etc.) into the storage chip of the ablation electrode.

[0295] In some embodiments, the ablation electrode 120 can be connected to the RF ablation device 110 via a connector. For example, the connector can be configured as a plug and a socket, and can include an aviation plug, an N-type connector, an SMA connector, and the like. For example, as shown in FIG1 , one end of the ablation electrode 120 is a connector that is inserted into the connector receptacle 1040 , and the ablation electrode 120 is connected to the RF ablation device 110 via the connector.

[0296] FIG27 is an exemplary module diagram of an ocular radiofrequency ablation apparatus according to some embodiments of the present specification.

[0297] In some embodiments, as shown in FIG. 27 , the radiofrequency ablation device 110 may include a control module 113 , a radiofrequency module 112 , an impedance detection module 115 , and an information reading module 116 .

[0298] In some embodiments, the control module 113 is used to communicate with the radiofrequency module, the impedance detection module, and the information reading module to control the radiofrequency ablation device to generate radiofrequency energy. In some embodiments, the control module 113 can be communicatively connected or electrically connected to the radiofrequency module 112, the impedance detection module 115, and the information reading module 116. The control module 113 can read information from the modules connected to it or send control instructions to each component to achieve control of the radiofrequency ablation device 110. For example, the control module 113 can receive the impedance information of the target tissue detected by the impedance detection module 115 and determine whether the ablation electrode has reached the target position of the eye based on the impedance information. For another example, the control module 113 can receive electrode information of the ablation electrode obtained by the information reading module 116 and determine whether the ablation electrode is available based on the electrode information. If available, the control module outputs the electrode information; if not available, the control module outputs a warning message (such as "Electrode verification failed, please replace the electrode" or "Electrode life end, please replace the electrode"). For another example, the control module 113 can detect the operating status of the radiofrequency ablation device and / or its accessories (such as a foot switch, ablation electrodes), determine the occurrence of a warning or error, and output a warning message or prompt sound through the output unit. For more information on this part, please refer to the following.

[0299] The impedance detection module 115 is used to detect impedance information before, during, or after RF energy delivery. In some embodiments, the impedance detection module 115 is used to detect the impedance information of the target tissue during the ablation process and transmit this impedance information to the control module. For example, before RF energy delivery, in response to a user inserting an ablation electrode into the patient's target tissue, the impedance detection module may detect the impedance information of the target tissue. This impedance information may include real-time impedance.

[0300] In some embodiments, as shown in FIG. 4 , the impedance detection module 115 may include an impedance monitoring unit 1151 and a voltage and current feedback unit 1152 .

[0301] The impedance monitoring unit 1151 is used to monitor the impedance information of the target tissue before and after the RF energy is output. In some embodiments, the impedance monitoring unit 1151 may include a bioimpedance detection chip.

[0302] In some embodiments, the impedance monitoring unit 1151 can obtain impedance information of the target tissue and send the impedance information to the control module 113. The control module 113 controls the output unit (such as the output unit 1142) to display the impedance information of the target tissue. The impedance information can help the user determine whether the tip of the ablation electrode is inserted into the location requiring treatment (i.e., the target location).

[0303] In some embodiments, as shown in FIG. 4 , the impedance monitoring unit 1151 may be connected to the control module 113 and the ablation electrode 120 via an electrode switching unit.

[0304] The electrode switching unit is used to connect the ablation electrode 120 to the impedance monitoring unit 1151 or to connect the ablation electrode 120 to the RF module 112. In some embodiments, the electrode switching unit may include a single-pole double-throw switch, such as a relay switch, an analog switch, or a switch circuit.

[0305] In some embodiments, in response to before the RF energy starts to be output or after the output stops, the control module 113 may control the single-pole double-throw switch to connect the impedance monitoring unit 1151 to the ablation electrode 120 .

[0306] In some embodiments, in response to outputting RF energy, the control module 113 may control a single-pole double-throw switch to connect the RF module 112 to the ablation electrode 120 , so that the RF module 112 provides RF energy to the ablation electrode 120 .

[0307] It is understandable that the electrode switching unit can ensure that the impedance monitoring unit 1151 and the RF module 112 are not turned on at any time, thereby avoiding device failure due to RF energy entering the impedance monitoring unit 1151.

[0308] The voltage and current feedback unit 1152 is used to monitor the impedance information of the target tissue during the output of radio frequency energy.

[0309] In some embodiments, the current and voltage sampling unit can obtain the impedance information of the target tissue and send the impedance information to the control module 113, which controls the output unit (such as the output unit 1142) to output the impedance information of the eye tissue. The impedance information can help the user judge the change between the actual RF power and the set RF power. The set RF power is the maximum power during the treatment process. During the treatment process, the target tissue loses water and the impedance increases. Power P = U 2 / R, the voltage remains unchanged and the power will gradually decrease; therefore, the change in impedance information can reflect the degree of radiofrequency ablation; when the impedance suddenly changes, the radiofrequency ablation device will stop outputting radiofrequency energy even if the timer has not reached the treatment time, which can further ensure the safety of radiofrequency ablation.

[0310] The information reading module 116 is used to obtain electrode information of the ablation electrode when the ablation electrode is connected to the radiofrequency ablation device. In some embodiments, the information reading module 116 reads the electrode information of the ablation electrode connected to the radiofrequency ablation device and transmits the electrode information to the control module 113.

[0311] In some embodiments, in response to the ablation electrode 120 being electrically connected to the radiofrequency ablation device 110, the information reading module 116 can automatically obtain electrode information of the ablation electrode 120 and send it to the control module 113. In some embodiments, after ablation is completed, in response to the remaining number of uses of the ablation electrode being not zero, the control module 113 can actively write the ablation electrode usage information (such as usage time, number of uses, or number of remaining uses) recorded by the radiofrequency ablation device into the ablation electrode.

[0312] In some embodiments, as shown in FIG. 4 , the radiofrequency ablation apparatus 110 further includes a human-computer interaction unit 1141 and an output unit 1142 .

[0313] The human-computer interaction unit 1141 can be used to control the start and stop of RF energy output and / or set target parameters. In some embodiments, the human-computer interaction unit may include an activation switch, a foot switch, and input buttons. The input buttons can be real buttons or virtual buttons. For example, virtual buttons can be function buttons on a touch screen display. Real buttons can include keyboard, mouse, or other buttons.

[0314] As shown in Figure 1, the activation switch 1030 can be a real button for activating the output control of the radio frequency energy. In some embodiments, the activation switch is used to activate the radio frequency module when it is turned on after a first preset condition is met.

[0315] The first preset condition is that all functions of the radiofrequency ablation device are normal, the foot switch is connected, the connected ablation electrode is available, and the target parameters have been determined. When the first preset condition is met, the activation switch is turned on, and the control module can control the radiofrequency module to generate radiofrequency energy.

[0316] It should be noted that the activation switch is not controlled by software, but by the RF signal. If the activation switch is turned off, the RF generating circuit will be in an off state, and the control module 113 will not send a control signal for RF output, and RF energy output control cannot be achieved.

[0317] During the ablation process of the target tissue, if the output of RF energy is abnormal or an emergency occurs (such as patient physical abnormality, equipment failure, etc.), the user turns off the activation switch and the RF module 112 stops outputting RF energy.

[0318] In some embodiments, in response to abnormal activation of the activation switch, the control module 113 may send a warning message to the output unit 1142 and display the warning message to prompt the user. The warning message may include, for example, "Please release the activation switch." In some embodiments, abnormal activation of the activation switch includes activation of the activation switch when a first preset condition is not met. For more information about the first preset condition, see above.

[0319] The foot switch is used to control the start and stop of the radiofrequency energy output after the second preset condition is met. In some embodiments, the connection method between the foot switch and the radiofrequency ablation device can include cable connection and wireless network connection.

[0320] The second pre-set condition refers to the ablation electrode being inserted into the target tissue and reaching the target location after the first pre-set condition is met. In some embodiments, the second pre-set condition also includes the RF ablation device entering the treatment interface. Understandably, further treatment information is not displayed before entering the treatment interface. At this time, the physician is uncertain about the RF energy output, so entering the treatment interface before RF energy is delivered is necessary. For more information about the treatment interface, see Figure 24.

[0321] In some embodiments, in response to the foot switch being disconnected from the RF ablation device, the control module 113 may send a warning message to the output unit 1142 and display the warning message. The warning message may include, for example, "Foot switch not connected" so that the user can connect the foot switch to the RF ablation device.

[0322] In some embodiments, in response to abnormal activation of the foot switch (e.g., activation when the second preset condition is not met), the control module 113 may send a warning message to the output unit 1142 and display the warning message. The warning message may include, for example, "Please release the foot switch."

[0323] During radiofrequency ablation, doctors perform ophthalmic surgery under a microscope while simultaneously holding electrodes. In some embodiments of this specification, a foot switch is provided to control the start and stop of radiofrequency energy output, facilitating treatment operations. It is understood that radiofrequency ablators can also operate without a foot switch, with another operator (such as a physician's assistant) controlling the start and stop of radiofrequency energy output. Alternatively, the control switch can be provided in other ways (such as on the operating handle of the ablation electrode).

[0324] Output unit 1142 can be used to display treatment information, electrode information, and / or prompt information to the user. For an explanation of treatment information, electrode information, and prompt information, see FIG. 28 . In some embodiments, the output unit can include a display screen (e.g., display screen 610 ) or an audio device (e.g., audio device 430 ).

[0325] The real-time clock 440 is used to provide time information for the radiofrequency ablation device 110. In some embodiments, the user can set the real-time clock through the human-computer interaction unit 1141 (such as a touch interface of a touch screen display) when the radiofrequency ablation device is used for the first time. For example, the user can set the real-time clock in the clock setting interface 600 shown in Figure 26. In some embodiments, in response to the time on the real-time clock 440 being inaccurate, the control module 113 can control the display screen to enter the clock setting interface (such as the interface shown in Figure 26) so that the user (such as an after-sales maintenance personnel or engineer) can adjust the time information.

[0326] It should be understood that the system and its modules shown in FIG27 can be implemented in various ways. For example, in some embodiments, the information reading module can be integrated into the control module, and the output unit can be another device that is communicatively connected to the control module, such as a smartphone or a laptop computer.

[0327] It should be noted that the above description of the radiofrequency ablation device and its modules is only for the convenience of description and does not limit this specification to the scope of the embodiments cited. It is understandable that for those skilled in the art, after understanding the principle of the system, it is possible to arbitrarily combine the various modules, or form a subsystem to connect with other modules without deviating from this principle. In some embodiments, the control module, radio frequency module, impedance detection module and information reading module disclosed in Figure 27 can be different modules in a system, or a module can realize the functions of two or more of the above modules. For example, each module can share a storage module, or each module can have its own storage module. Such variations are all within the scope of protection of this specification.

[0328] FIG28 is an exemplary flow chart of a control method according to some embodiments of the present specification. As shown in FIG28 , process 1900 may include the following steps:

[0329] Step 1910 : In response to the radiofrequency ablation device being turned on, detecting whether the radiofrequency ablation device functions normally.

[0330] Turning on the device can refer to starting the radiofrequency ablation device by pressing a button or other means (such as voice).

[0331] In some embodiments, before powering on the device, pre-power-on preparations may be performed, such as connecting the power supply, connecting the foot switch, etc. In some embodiments, after powering on the device, it may be possible to detect whether the RF ablation device is powered on normally (e.g., whether the system is powered on normally, whether the system power button is activated normally, whether the system can enter the power-on screen normally, etc.).

[0332] In some embodiments, in response to the radiofrequency ablation apparatus being powered on normally, the control module may automatically detect whether each module of the radiofrequency ablation apparatus is operating normally.

[0333] In some embodiments, detecting whether the function of the radiofrequency ablation device is normal includes at least one of the following: detecting whether the foot switch and / or activation switch is abnormally started; detecting whether the status of the analog-to-digital converter of the radiofrequency ablation device is normal; detecting whether the size of the radiofrequency output frequency is normal; detecting whether the real-time clock is accurate; detecting whether the serial port communication is normal; detecting whether the power supply is normal; and detecting whether the reading and writing of the memory are normal.

[0334] In some embodiments, if the foot switch is detected to be disconnected, a prompt message such as "Foot switch not connected" can be displayed on the display interface. In some embodiments, the detection of whether the foot switch is connected can be performed in other steps. For example, when the ablation electrode is available and the user confirms the electrode information, the foot switch connection can be detected. In some embodiments, the connection of the foot switch can be monitored in real time throughout the ablation process. For more information on abnormal activation of the foot switch or activation switch, see above.

[0335] In some embodiments, a prompt can be triggered when the foot switch or activation switch is activated without the ablation electrode connected. In some embodiments, the prompt can include: Please release the activation switch, or Please release the foot switch. For example, when the foot switch is activated without the ablation electrode connected, the display screen of the RF ablation device prompts "Please release the foot switch"; when the activation switch is activated without the ablation electrode connected, the display screen of the RF ablation device prompts "Please release the activation switch." Triggering the prompt indicates that the RF energy control switch is able to connect and communicate normally.

[0336] In some embodiments, in response to an abnormality in the function of a module of the radiofrequency ablation device, a display screen may display a prompt message. The prompt message may include an error code. The error code may indicate different errors detected. For example, E01-12V indicates a detection error, E04-DAC indicates an output abnormality, etc.

[0337] In some embodiments, the function of the radiofrequency ablation device can be detected in various ways. For example, the function of one or more modules of the radiofrequency ablation device can be determined by detecting changes in current, voltage, and signal.

[0338] In some embodiments, whether the state of the analog-to-digital converter (ADC) of the radiofrequency ablation device is normal can be detected by reading the output data of the ADC chip through SPI communication to determine whether the state is normal.

[0339] Detecting whether the magnitude of the RF output frequency is normal refers to the process of measuring and monitoring the frequency of the RF signal. In some embodiments, a timer-capture driver module and / or a DDS (Direct Digital Synthesis) driver module can be used to achieve measurement and generation of the RF signal frequency. The timer-capture driver module refers to a timer module inside a microcontroller unit or a digital signal processor (DSP) that achieves measurement by capturing the time of external events. Exemplarily, in the detection of the magnitude of the RF output frequency, a timer-capture driver module can be used to measure the period or pulse width of the RF signal to calculate the frequency magnitude; by capturing the time interval of the rising edge or falling edge of the RF signal, the frequency of the RF signal can be accurately calculated.

[0340] The DDS driver module can generate precise frequencies digitally, including components such as a phase accumulator, a sine wave table, and a digital-to-analog converter. For example, the DDS driver module can generate a radio frequency signal at a specific frequency. By controlling the DDS phase accumulator, the desired radio frequency signal frequency can be precisely generated, and rapid frequency switching and adjustment can be achieved.

[0341] In some embodiments, the timer-capture driver module can measure the actual output frequency of the RF signal, while the DDS driver module can generate an RF signal of a specific frequency. The two methods can be combined to achieve accurate measurement and generation of the RF signal frequency.

[0342] In some embodiments, detecting whether the real-time clock is accurate may include comparing the time of the real-time clock with the most recent time recorded by the device, and determining that the real-time clock is inaccurate if the time of the real-time clock is earlier than the time recorded by the device. In some embodiments, in response to the real-time clock being inaccurate, after-sales maintenance personnel are prompted to adjust the time.

[0343] In some embodiments, in response to the first use of the radiofrequency ablation device, the display screen may display a clock setting page. The user cannot set the system time at other times; if the real-time clock is inaccurate (such as the time of the real-time clock is before the time recorded by the device), the system time needs to be set, and the after-sales maintenance personnel can be reminded to adjust the time. After-sales maintenance personnel or technicians can use engineering electrodes to set the time setting page; in addition, after-sales maintenance personnel can also correct some electrode information in the engineering interface (such as when the information is incorrect) and rewrite or perform other background settings. The engineering electrode is a type of ablation electrode, and the control module 113 can determine whether it is an engineering electrode through a variety of methods such as the access signal of the engineering electrode, the engineering electrode model or the verification code. It is understandable that the radiofrequency ablation device can calculate the life of the ablation electrode based on the system time, and the radiofrequency ablation device does not include the network time, so the time can only be set when it is turned on for the first time. The time setting authority for other situations is not open to the user.

[0344] In some embodiments, the accuracy of the real-time clock can be detected by reading the RTC chip function and using a communication interface driver.

[0345] In some embodiments, detecting whether serial port communication is normal may be achieved through a serial port driver.

[0346] In some embodiments, to detect whether the power supply is normal, the analog-to-digital converter (ADC) of the microcontroller unit can be used to monitor changes in the power supply voltage or current to determine whether the power supply is normal; for example, whether the voltage is 3.3V, 5V, 12V, etc.

[0347] In some embodiments, detecting whether the memory reads and writes normally can be implemented by using the memory's IIC (Inter-Integrated Circuit) interface driver. For example, when the memory 420 is an electrically erasable programmable read-only memory, detecting whether the memory reads and writes normally can be implemented by performing read and write operations on the EEPROM through the IIC interface driver to verify whether the data is correct.

[0348] In some embodiments, detecting whether the radiofrequency ablation apparatus functions normally may further include detecting the function and initialization of a touch screen. The function of the touch screen may include setting the touch sensitivity of the touch screen.

[0349] In some embodiments, initialization refers to the control module detecting and identifying the external device and establishing communication with it after the radiofrequency ablation device is turned on. Through initialization, the control module can correctly exchange data and perform control operations with the external device.

[0350] In some embodiments, detecting whether the radiofrequency ablation device functions properly may further include interrupt transaction processing. In some embodiments, interrupt transaction processing includes: responding to an interrupt signal at an interrupt entry, identifying an interrupt number; interrupt number identification includes serial communication interrupt tasks, timer interrupt tasks, and short circuit detection interrupt tasks; and returning to the interrupt exit in response to completion of the interrupt transaction processing.

[0351] Interrupt transaction processing refers to the process whereby, when a control module receives a higher-priority event or request while executing certain tasks, it pauses the current task and instead processes the event or request. In some embodiments, interrupt transaction processing can occur at various stages, such as during normal startup of the RF ablation device, during functional testing of the device, or during ablation of target tissue.

[0352] Step 1920 : In response to all functions of the radiofrequency ablation apparatus being normal, it is detected whether the ablation electrode connected to the radiofrequency ablation apparatus is usable.

[0353] In some embodiments, the control module 113 can verify the ablation electrode based on the electrode information obtained by the information reading module, and in response to the ablation electrode being unavailable, provide a prompt. In some embodiments, in response to the ablation electrode being available, the control module 113 displays the electrode type and electrode life information of the ablation electrode and requests confirmation.

[0354] Electrode information refers to information related to the ablation electrode. In some embodiments, the electrode information may include the chip model of the ablation electrode, encryption information, electrode type, model, electrode validity period information, electrode life information, data verification code, etc. Among them, the encrypted information refers to the information used to verify whether the electrode is a legitimate electrode. The first use time refers to the time when the ablation electrode is first connected to the radiofrequency ablation device. The data verification code can be used to verify that the data obtained by the input / output unit is consistent with the data in the storage chip to determine whether the ablation electrode is legitimate. The data verification code may include a CRC check code.

[0355] In some embodiments, the availability of the ablation electrode includes: the ablation electrode is not an illegal electrode, is within its validity period, and the remaining number of uses or remaining ablation time of the ablation electrode is not 0. An illegal electrode refers to an electrode that cannot be matched or matched with a radiofrequency ablation device.

[0356] In some embodiments, the expiration date includes the expiration date on the ablation electrode packaging and a preset usage time range after first use after unpacking. The expiration date on the ablation electrode packaging can be obtained from information on the packaging, including the production date and the production shelf life.

[0357] The production date refers to the date the ablation electrode leaves the factory. The production shelf life refers to the time from the production date to the expiration date of the ablation electrode. The preset usage time range can reflect the interval time after the ablation electrode is last used and can be used for ablation again. For example, after ablation electrode A is unsealed and used to complete ablation of the target tissue, the remaining number of uses is not 0, and the ablation ends at 10 am on December 1st. To ensure aseptic operation, the preset usage time range can be set to 4 hours (or 2 hours, 3 hours, 5 hours, 6 hours, 8 hours, etc.). If electrode A is used for ablation again at 1 pm on December 1st, the time interval between the two uses is 3 hours, which is less than 4 hours, and therefore within the preset usage time range; if it is used for ablation again at 3 pm on December 1st, the time interval between the two uses is 5 hours, which is greater than 4 hours, and therefore exceeds the preset usage time range. In some embodiments, the electrode expiration date may also include the first use time and the preset usage time range after the first use. The first use time refers to the time when the ablation electrode is first connected to the radiofrequency ablation device. The preset usage time range after the first use refers to the interval time during which the electrode can be used again for ablation after it is unpacked for the first time.

[0358] In some embodiments, the electrode life information includes the number of times the electrode has been used and the number of times it remains to be used, or the cumulative ablation time and the remaining ablation time. In some embodiments, the number of times the electrode has been used and the number of times it remains to be used, or the cumulative ablation time and the remaining ablation time, can be actively updated and written into the storage chip of the ablation electrode 120 by the radiofrequency ablator 110 after each use of the ablation electrode. In some embodiments, in response to the end of each use of the ablation electrode, the cumulative ablation time in the storage chip can be increased by the time the ablation electrode is used, and the remaining ablation time can be reduced by the time the ablation electrode is used.

[0359] In some embodiments, the radiofrequency ablation device 110 can determine whether the ablation electrode is available in a variety of ways. For example, the control module 113 can verify the encryption information of the ablation electrode. If the encryption information is correct, the ablation electrode is determined to be an authorized and legal electrode. At the same time, it is checked whether the ablation electrode has exceeded the validity period (production shelf life and preset usage time range) and the remaining number of uses or the remaining ablation time. If the ablation electrode is within the shelf life and has not exceeded the preset usage time range and the remaining number of uses or the remaining ablation time is not 0, the ablation electrode is determined to be available. Among them, the encryption information can be constructed in a variety of ways, for example, symmetric encryption, asymmetric encryption, etc. Exemplarily, the encryption information of the ablation electrode is constructed by symmetric encryption. When the control module receives the encrypted information, it can decrypt the encrypted information by using a key. If it cannot be decrypted or the decrypted information is incorrect, the control module can determine that the ablation electrode is an illegal electrode and control the output unit (such as output unit 1142) to output a warning message, such as "The electrode is illegal, please replace the electrode."

[0360] In some embodiments, the radiofrequency ablation device may first detect the connection status of the ablation electrode and, in response to the ablation electrode 120 being disconnected from the radiofrequency ablation device, send a prompt message to the output unit. The output unit may output the prompt message to the user (e.g., by displaying the prompt message on a display screen), and the prompt message may include, for example, "electrode not connected."

[0361] In some embodiments, in response to determining that an ablation electrode is unavailable, an output unit may prompt the user to replace the ablation electrode. For example, the prompt may include "electrode unauthorized" or "electrode lifespan expired." In some embodiments, availability checks may continue for the replaced ablation electrode until a new ablation electrode is available.

[0362] In some embodiments, the reasons for the ablation electrode being unavailable are different, and the content of the prompt is different. For example, if the ablation electrode fails to pass the legality verification, the prompt "Electrode not authorized" or "Electrode illegal, please replace the electrode" may be displayed; if the electrode is not within the validity period, the prompt may be different according to the reason for not being within the validity period, such as "Expired the preset time range for first use after unpacking", "Electrode has expired", and "Electrode usable life is 0" when the remaining number of uses or remaining ablation time of the ablation electrode is insufficient.

[0363] In some embodiments, in response to the ablation electrode being available, the control module 113 can send the electrode information to the output unit, so that the output unit outputs and displays the electrode information for the user to confirm. Figure 22 is an exemplary schematic diagram of an electrode information confirmation interface shown in some embodiments of this specification. As shown in Figure 22, the interface can display the electrode type and electrode life. The electrode type includes an electrode icon, and different electrode icons can be displayed for different electrode types; the electrode life can include the number of times it has been used and the number of times it remains to be used; when the information is correct, the user can click the "Confirm" button in the figure to confirm; when there is an error, the electrode can be replaced or the after-sales maintenance personnel can be requested to handle it. The after-sales maintenance personnel can correct and rewrite the error information stored in the electrode.

[0364] In some embodiments, the prompt information or warning information may be displayed on a display screen, or may be issued through sound, vibration, or the like.

[0365] In some embodiments, the information reading module may obtain electrode information of the ablation electrode and transmit the electrode information to the control module to determine whether the ablation electrode is available.

[0366] Step 1930: In response to the ablation electrode being available and the electrode information being confirmed, enter the parameter setting interface.

[0367] In some embodiments, in response to all functions of the radiofrequency ablation device being normal, the ablation electrode is available and confirmed by the user (such as the user has confirmed the electrode type, etc.), the parameter setting interface 700 (as shown in Figure 23) can be entered so that the user can set the target parameters.

[0368] Figure 23 is an exemplary schematic diagram of a parameter setting interface according to some embodiments of this specification. In some embodiments, as shown in Figure 23, the parameter setting interface 700 may include accessory connection status, treatment time, radiofrequency power, and electrode life information.

[0369] Among them, the accessory connection status may include an electrode icon and a foot switch icon. The electrode icon includes the electrode type (such as a ciliary body electrode, a trabecular meshwork electrode, or an iris electrode) and an electrode legend. In some embodiments, when the ablation electrode and / or the foot switch are not connected, clicking Confirm (as shown in FIG22 ) will also enter the parameter setting interface to facilitate demonstration operations or teaching; at this time, in response to the ablation electrode not being connected, the electrode icon may be displayed in gray, and in response to the foot switch not being connected, the foot switch icon may be displayed in gray.

[0370] The treatment time (i.e., the duration of the radiofrequency energy output) may include time information, including the treatment time duration and a time adjustment button. The time adjustment button may be used to set the duration of the treatment of the target tissue.

[0371] The radio frequency power (i.e., the output power of the radio frequency energy) may include power information, including the radio frequency power level and a power adjustment button. The power adjustment button may be used to set the output power level of the radio frequency energy when ablating the target tissue.

[0372] The electrode life information may include the number of times the current electrode has been used and the number of times it remains to be used, or the accumulated ablation time and the remaining ablation time.

[0373] Step 1940 , in response to the ablation electrode being available before or after the electrode information is confirmed, detecting whether the foot switch is connected.

[0374] In some embodiments, the ocular radiofrequency ablation device further includes a foot switch interface for connecting a foot switch. In some embodiments, the control module is further configured to: detect whether the foot switch is connected before or after the electrode type and electrode life information of the ablation electrode are confirmed; provide a prompt if the foot switch is not connected; and enter a parameter setting interface in response to the foot switch being connected or the user clicking a confirmation button in the prompt interface.

[0375] In some embodiments, when the ablation electrode is available and the user confirms the electrode information or before confirmation, it is possible to detect whether the foot switch is connected. If it is not connected, a prompt message "Foot switch not connected" is output in the display interface. At this time, the user can proceed to the next step by clicking the "Confirm" button in the interface or connecting the foot switch, such as entering the parameter setting interface shown in Figure 23. It is worth noting that the connection order of the foot switch and the ablation electrode is not restricted. In some embodiments, it is possible to first detect whether the foot switch is connected and then detect whether the ablation electrode is connected, or detect whether the foot switch and the ablation electrode are connected at the same time, or first detect whether the ablation electrode is connected and then detect whether the foot switch is connected. In some embodiments, if the foot switch is connected, the start-up status of the foot switch can be monitored in real time. In some embodiments, the parameter setting interface shown in Figure 23 can be entered after the electrode information is confirmed, and whether the foot switch is connected can be detected before or after.

[0376] Step 1950 , in response to the foot switch being connected and based on the target parameters recommended by the parameter setting interface or set in the parameter setting interface, controlling the output or stopping of the radio frequency energy.

[0377] Target parameters refer to determined ablation parameters. Ablation parameters refer to parameters used when performing radiofrequency ablation on target tissue. In some embodiments, ablation parameters may include the output power of the radiofrequency signal (referred to as radiofrequency power), treatment time, treatment mode, etc.

[0378] Different target eye tissues are targeted by radiofrequency ablation, and different electrode types are used. For example, the types of electrodes may include ciliary body electrodes, trabecular meshwork electrodes, or iris electrodes. If the target tissue is the ciliary body, the electrode used is a ciliary body electrode. If the target tissue is the trabecular meshwork, the electrode type used should be a trabecular meshwork electrode. If the target tissue is the iris, an iris electrode is used. For different target tissues, considering the morphology, location, and operability of the target tissue, the difference in the electrode mainly lies in the different morphological structures of the electrode needle, such as whether the end of the electrode needle that penetrates the target tissue is a straight needle, a curved needle with a straight tip, or a curved needle with a curved tip.

[0379] In some embodiments, the RF ablation device 110 can automatically detect, identify, and display the electrode type of the ablation electrode connected to the RF ablation host and request user confirmation (see FIG22 ). For example, the control module 113 can automatically detect and identify the electrode type of the ablation electrode connected to the RF ablation device 110 based on the information reading module 116, without requiring the operator to select the electrode type, thereby improving safety and preventing the operator from selecting an inconsistency between the electrode type actually used and the electrode type selected.

[0380] The output power of the radio frequency signal reflects the power of radio frequency ablation. In some embodiments, the output power can be in the range of 0.5-50w. For example, the output power can be any value within the range of 0.5-9.9w. In some embodiments, the output power of the radio frequency signal can be obtained in a variety of ways. For example, in response to the availability of the ablation electrode, the radio frequency ablation instrument can provide multiple alternative output powers for the user to choose based on the electrode type, and in response to the user selecting one of the alternative output powers through a preset input method, the selected alternative output power is determined as the output power of the radio frequency signal. For more instructions on determining whether the ablation electrode is available, please refer to the relevant description above.

[0381] In some embodiments, the alternative output power can be pre-set based on historical experience. For example, the alternative output power can be determined based on the output power of the radiofrequency signal used in a completed radiofrequency ablation procedure. In some embodiments, the alternative output power can have a range of values ​​(e.g., 0.5-9.9W) or multiple specific values.

[0382] Treatment time refers to the treatment time at a location after each insertion during radiofrequency ablation of target tissue. In some embodiments, treatment time can be obtained in a variety of ways. For example, in response to the availability of an ablation electrode, the control module 113 can provide multiple alternative treatment times based on the electrode type and control the output unit 1142 to display them on the display interface for user selection. When the user selects one of the alternative treatment times through a preset input method, the selected alternative treatment time is determined as the treatment time.

[0383] In some embodiments, the candidate treatment time can be pre-set based on historical experience. For example, the candidate treatment time can be determined based on the treatment time used in a completed radiofrequency ablation procedure. In some embodiments, the candidate treatment time can be a time range (e.g., 1-20 seconds, 10-100 seconds, etc.), or multiple specific time values.

[0384] In some embodiments, the treatment mode may include a continuous treatment mode and a single treatment mode.

[0385] Continuous treatment mode means that after the tip of the electrode needle enters the target tissue, RF energy can be released multiple times at the same treatment location, that is, released intermittently. The corresponding treatment time is the accumulation of multiple release times. Correspondingly, single treatment mode means that after the tip of the electrode needle enters the target tissue, RF energy is released once. The corresponding treatment time is the duration of this RF energy release.

[0386] In some embodiments, the treatment information may include treatment time, output power of the radio frequency signal, real-time impedance, etc.

[0387] The treatment time refers to the time during which radiofrequency ablation has been performed at a radiofrequency ablation site. In some embodiments, the control module 113 can determine the treatment time by a timer and output it through the output unit 1142 (such as the display screen 610).

[0388] Real-time impedance can be used to characterize the real-time impedance of the target tissue. For more information about real-time impedance, please refer to the above description.

[0389] In some embodiments, in response to user confirmation of the electrode type and electrode life information of the ablation electrode, the control module may recommend target parameters. In some embodiments, the control module may determine candidate ablation parameters based on the electrode type of the ablation electrode and determine template parameters based on user input regarding the candidate ablation parameters; the candidate ablation parameters may include recommended parameter values ​​related to the target parameters or user-selectable parameter ranges to improve treatment safety. In some embodiments, the target parameters include the output duration and output power of the RF energy.

[0390] Candidate ablation parameters refer to recommended ablation parameters (such as alternative treatment time, alternative radiofrequency power). In some embodiments, the candidate ablation parameters may include parameter values ​​or parameter ranges of recommended target ablation parameters. The input information may include adjustment information or confirmation information of the recommended parameter value by the user, or target parameters input by the user based on the recommended parameter range. In some embodiments, in response to receiving confirmation information from the user on the electrode, the control module may determine the parameter value corresponding to the confirmation information as the target parameter.

[0391] Exemplarily, in response to the availability of the ablation electrode, the control module 113 can recommend the treatment time, the output power of the radio frequency signal, or the parameter value / parameter range of the treatment mode according to the electrode type of the ablation electrode, and control the output unit to be displayed on the display interface for the user to adjust the parameter value and confirm or input the parameter within the recommended parameter range, and use the confirmed parameter value as the determined target parameter, or use the parameter within the recommended parameter range as the confirmed target parameter. Exemplarily, the parameter value related to the target parameter or the parameter range selectable by the user may also not be displayed on the display interface, and the target parameter may be limited to the parameter range by limiting the user's adjustment range.

[0392] In some embodiments, before determining the target parameters, the status of the activation switch can be monitored in real time. A prompt is provided in response to abnormal activation of the activation switch. For example, in response to the activation switch being activated without satisfying the first preset condition, the display interface can display a reminder such as "Please release the activation switch." The first preset condition includes that all functions of the radiofrequency ablation device are normal, the foot switch is connected and the connected ablation electrode is available, and the target parameters have been determined. For an explanation of the first preset condition and the second preset condition, please refer to the above and the related descriptions.

[0393] In some embodiments, in response to the activation switch being actuated when a first preset condition is satisfied (all functions of the radiofrequency ablation device are normal, the foot switch is connected and the connected ablation electrode is available, and target parameters have been determined), a determination is made as to whether the ablation electrode has reached the target position. In some embodiments, when the ablation electrode has reached the target position, in response to the foot switch being actuated, the output of the radiofrequency energy is controlled based on the target parameters.

[0394] In some embodiments, in response to the user pressing the foot switch for more than a preset time, the control module 113 can control the RF module 112 to start outputting RF energy. The preset time may include 1 second.

[0395] In some embodiments, the ablation electrode is determined to have reached the target location in response to impedance information reaching a preset value or the ablation electrode reaching a predetermined depth. The control module can determine whether the ablation electrode has reached the target location in the eye based on the impedance information detected by the impedance detection module. For example, if the impedance detection module detects impedance information, i.e., the impedance information is not zero or is within a preset impedance threshold range, the ablation electrode can be determined to have reached the target location and the output of RF energy can be controlled. In some embodiments, the impedance information detected by the impedance detection module can be obtained. If the impedance information reaches a preset value, the ablation electrode is determined to have reached the target location; otherwise, the ablation electrode is determined not to have reached the target location. The preset value can be determined based on actual conditions; for example, different preset values ​​can correspond to different target tissue locations. In some embodiments, the control module can determine whether the ablation electrode has reached the target location by detecting whether the depth reached by the ablation electrode meets a predetermined depth. For example, if the tip of an ablation electrode protrudes a preset distance, the ablation electrode can be considered to have reached the predetermined depth when the tip of the electrode needle fully penetrates the eye. The preset distance can be adjusted based on actual conditions. For example, the preset distance, and thus the predetermined depth, can be adjusted by adjusting the protruding length of the tip.

[0396] In some embodiments, during the ablation of the target tissue, the impedance information of the target tissue can be monitored in real time, and when the impedance suddenly changes, the output of radiofrequency energy is stopped. It is understandable that when radiofrequency ablation is completed, the impedance of the target tissue will suddenly change, and the impedance sudden change can indicate the completion of radiofrequency treatment. Specifically, the mutation threshold can be determined according to different target tissues, such as when the impedance is greater than a certain value. Alternatively, the impedance sudden change can also be judged by the change in the impedance change amount (difference) collected multiple times, for example, the impedance change tends to zero to form an inflection point, or the impedance change increment exceeds a preset value.

[0397] In some embodiments, during the ablation of the target tissue, the radiofrequency ablation device automatically stops outputting radiofrequency energy in response to the release of a foot switch or when the timing reaches a preset time threshold.

[0398] In some embodiments, the radiofrequency ablation device may be configured to have a continuous output mode and a timed output mode, wherein the continuous output mode or the timed output mode may reflect the output method of the radiofrequency energy.

[0399] The continuous output mode means that in response to the user activating the foot switch, the control module 113 controls the RF module 112 to start outputting RF energy, and in response to the user deactivating the foot switch, the control module 113 controls the RF module 112 to stop outputting RF energy.

[0400] In timed output mode, in response to a user activating a foot switch, the control module 113 controls the RF module 112 to begin outputting RF energy and start timing. When the timing reaches a preset time threshold, the RF energy output automatically ceases. In some embodiments, in timed output mode, in response to the user deactivating the foot switch if the timing does not reach the preset time threshold, the control module 113 may control the RF module 112 to cease outputting RF energy. In some embodiments, the preset time threshold may be the treatment time or less.

[0401] In some embodiments, in response to the timing reaching a preset time threshold but the foot switch is not released, the control module 113 can send a warning message to the output unit to output a warning message. The warning message can include, for example, "Please release the foot switch."

[0402] In some embodiments, in the continuous output mode or the timed output mode, each time the output of radio frequency energy is stopped, the control module may record the usage information of the electrode and update the electrode life information of the currently used electrode.

[0403] In some embodiments, during ablation of target tissue, the RF ablation device may cease RF energy output in response to the activation switch being turned off. This can occur when the user releases the activation switch when no further treatment of the target tissue is necessary, or when the user presses the activation switch when an abnormality occurs during RF energy output.

[0404] In some embodiments, in response to the activation switch being started when the first preset condition is met, the treatment interface is entered. For more information about the first preset condition, please refer to the above. In some embodiments, after entering ablation (such as starting to output radiofrequency energy), treatment information can be displayed in the display interface. For example, the activation switch is started when the first preset condition is met, and after ablation of the target tissue begins, the treatment interface shown in Figure 24 can be entered. In some embodiments, the information displayed on the treatment interface includes at least one of the electrode status, electrode type, electrode life information, output duration of radiofrequency energy, real-time treatment time, output power of radiofrequency energy, and impedance information. Preferably, the information displayed on the treatment interface includes electrode status, electrode type, electrode life information, output duration of radiofrequency energy, output power of radiofrequency energy, real-time treatment time, and real-time impedance.

[0405] The electrode status refers to whether the ablation electrode is connected to the radiofrequency ablation device. A colored electrode icon indicates a connection, while a gray icon indicates a disconnection. Electrode types include ciliary body electrodes, trabecular meshwork electrodes, and iris electrodes.

[0406] The RF energy output duration (i.e., the set treatment time) and RF energy output power (i.e., the set RF power) are described above. Real-time treatment time, also known as elapsed treatment time, refers to the duration of the current treatment. For example, if the treatment time is 20 seconds, the elapsed treatment time is 2 seconds.

[0407] The output power of radio frequency energy is the power value that the radio frequency signal needs to meet when treating the target tissue (such as the radio frequency power set in the interface shown in Figure 23).

[0408] Real-time impedance refers to the current impedance value of the target tissue, such as the impedance value monitored by a voltage and current feedback unit.

[0409] In some embodiments, the status of the foot switch can be monitored in real time, and if the foot switch is activated in a non-treatment interface (ie, activated before entering the interface shown in FIG. 24 ), a prompt is given.

[0410] In some embodiments, in response to the completion of radiofrequency ablation, the radiofrequency ablation device can detect the remaining number of uses of the ablation electrode. If the remaining number of uses is not zero, information such as the first use time, the number of uses, and the remaining number of uses of the ablation electrode can be actively written into the ablation electrode (e.g., a memory chip of the ablation electrode).

[0411] In some embodiments, the control module's process of controlling the output or stopping of RF energy further includes: controlling the RF energy output to stop when a sudden change in impedance occurs; or automatically stopping the RF energy output in response to the release of a foot switch, the closure of an activation switch, or the expiration of the RF energy output duration. For more information, see Figure 19.

[0412] Fig. 19 is an exemplary flow chart of a control method according to some other embodiments of the present specification. As shown in Fig. 19, in some embodiments, process 900 may include the following steps, which may be executed by a control module.

[0413] Step 910: In response to the radiofrequency ablation device being turned on, detecting whether the radiofrequency ablation device functions normally.

[0414] In conjunction with the above, before turning on the device, you can first perform pre-startup preparations, such as connecting the power supply and the foot switch. After turning on the device, you can test whether the RF ablation device is starting up normally (e.g., whether the system is powered on, whether the system power button is activated normally, whether the boot screen can be normally entered, etc.). For more details on testing whether the RF ablation device is functioning normally, please refer to Figure 28 and will not be repeated here.

[0415] Step 920 : In response to the radiofrequency ablation device functioning normally, determine the availability of the ablation electrode.

[0416] After the RF ablation device functions normally (also known as passing the self-test), the user can connect the ablation electrode. The RF ablation device can obtain the electrode information of the connected ablation electrode. For example, the RF ablation device can obtain the electrode type, encryption information, data verification code and other electrode information of the connected ablation electrode through the information reading module 116, and transmit the electrode information to the control module 113. In some embodiments, the control module 113 can determine whether the ablation electrode is available based on the electrode information. For example, the control module 113 can determine whether the ablation electrode is an illegal electrode based on the encryption information and the electrode model, determine whether the first use time of the electrode exceeds the preset use time range based on the time, determine whether the service life meets the requirements based on the remaining number of uses of the electrode, etc. In response to determining that the ablation electrode is unavailable, the control module 113 can control the output unit to output a prompt message to remind the user to replace the ablation electrode. For more details, please refer to the description in Figure 28, which will not be repeated here.

[0417] In step 930 , in response to the ablation electrode being available, target parameters are set.

[0418] In some embodiments, in response to the ablation electrode being available, the control module 113 can control the output unit to output the electrode information for the user to confirm. After the user confirms the electrode information, the parameter setting page (the interface shown in FIG23 ) can be entered to set the target parameters. In some embodiments, the user can actively input the target parameters in the parameter setting interface. In some embodiments, the recommended candidate ablation parameters can be displayed in the parameter setting interface, and the target parameters can be determined based on the user's feedback on the candidate ablation parameters. For example, the target parameters are determined based on the user's adjustment information or confirmation information on the recommended parameter value, or the target parameters input by the user based on the recommended parameter range.

[0419] After determining the target parameters, treatment can begin. In conjunction with the above, when all functions of the RF ablation device are functioning normally, the foot switch is connected, the connected ablation electrode is available, and the target parameters have been determined, the activation switch can be activated to determine whether the ablation electrode has reached the target position. If so, the foot switch can be activated to activate the output of RF energy to ablate the target tissue.

[0420] In step 940 , in response to a sudden change in impedance, the release of a foot switch, the release of an activation switch, or the treatment time reaching a preset time threshold, the radiofrequency ablation device may stop outputting radiofrequency energy.

[0421] In some embodiments, as shown in FIG19 , during ablation of the target tissue, the RF ablation device may stop outputting RF energy in response to a sudden change in impedance, the release of a foot switch, or the release of an activation switch, or the treatment time reaching a preset time threshold (such as the timing reaching a set RF energy output duration).

[0422] In some embodiments, as shown in Figure 19, in response to the target tissue not needing further treatment and the user releasing the activation switch, the entire radiofrequency ablation process ends. If further treatment is required, the target tissue can be ablated again by reactivating the foot switch.

[0423] In some embodiments, in response to an abnormality occurring during the output of radiofrequency energy, the user presses an activation switch, causing the radiofrequency ablation device to stop outputting radiofrequency energy. In some embodiments, in response to the completion of radiofrequency ablation, the radiofrequency ablation device can write electrode information of the ablation electrode back to the memory chip of the ablation electrode.

[0424] It should be noted that the above description of control methods 900 and 1900 is for illustrative purposes only and does not limit the scope of application of this specification. Those skilled in the art will be able to make various modifications and alterations to the ocular radiofrequency ablation process under the guidance of this specification. However, such modifications and alterations remain within the scope of this specification.

[0425] In some embodiments, the radiofrequency ablation device 110 may further include a power filter 410, a power module 111, an audio device 430, a display screen 610, a rotary handle 1020, a cooling fan, a mainboard shield, an activation switch 1030, and related interfaces. The related interfaces may include a connector socket (such as connector socket 1040), a power switch and interface, an equipotential interface, and a foot switch interface.

[0426] The activation switch 1030 may be a push button or a rotary button. For more information about the power filter 410, the power module 111, the audio device 430, and the display screen, please refer to the above and will not be repeated here.

[0427] In some embodiments, the rotating handle 1020 can be installed on the upper part of the radiofrequency ablation device 110 for picking up and placing the radiofrequency ablation device. In some embodiments, the rotating handle 1020 may include a handle protrusion, a handle, a rotating shaft and a handle buckle. The handle protrusion allows the rotating handle to fall slowly to avoid colliding with the radiofrequency ablation device 110. The rotating handle 1020 can be connected to the radiofrequency ablation device 110 via a rotating shaft and rotated along the rotating shaft (such as rotating 0-180 degrees, 0-90 degrees, 0-160 degrees, etc.). The handle buckle finger facilitates the operator to buckle the handle from the state where it fits the radiofrequency ablation device to the structure of the picking up state. Exemplarily, the handle buckle can be a groove or protrusion on the handle.

[0428] In some embodiments, a cooling fan may be provided on one side of the RF ablation device 110, and a plurality of cooling holes may be provided on the housing of the RF ablation device 110 near the cooling fan to dissipate heat generated by the RF ablation device 110. In some embodiments, the cooling fan may also be other structures for cooling or dissipating heat.

[0429] In some embodiments, a motherboard shield can be provided inside the housing of the radiofrequency ablation device 110 to shield the interior of the radiofrequency ablation device from external electromagnetic interference, or vice versa. In some embodiments, the motherboard shield can be made of a conductive material, such as metal or plastic with a conductive coating. In some embodiments, the motherboard shield can be made of a metal material to shield interference while supporting the filter 410, power module 111, audio device 430 (such as a speaker), and cooling fan, providing support for their stable installation.

[0430] In some embodiments, a connector port can be provided on the side of the RF ablation device 110 where the display screen is located (also referred to as the front), for connecting a connector to connect the ablation electrode 120 to the RF ablation device 110. By providing the connector port on the side of the RF ablation device where the display screen is located, it is easier for the user to view information displayed on the display screen (such as electrode information, treatment information, warning information, etc.) during the ablation process.

[0431] In some embodiments, a power switch and interface, an equipotential interface, and a foot switch interface can be located on the back of the RF ablation device 110 (on the side opposite the display screen). The power switch and interface are used to connect the RF ablation device 110 to an external power source. The equipotential interface is used to ground the RF ablation device 110 when a grounded socket is unavailable, ensuring electrical safety. The foot switch interface is used to connect the foot switch to the RF ablation device 110.

[0432] By arranging the power switch and interface, equipotential interface and foot switch interface on the back of the radiofrequency ablation device, the appearance of the radiofrequency ablation device can be improved while ensuring use, while preventing the components connected to the interface from affecting the user's viewing of the displayed information on the display screen.

[0433] In some embodiments, the RF ablation device 110 can be fixedly or detachably mounted on a trolley to facilitate movement and operation of the RF ablation device 110. The trolley is used to carry the RF ablation device 110. When the RF ablation device 110 is mounted on the trolley, the RF ablation device can be moved by moving the trolley (e.g., to the operator's location). The specific trolley structure is as described above, and can also be seen in Figures 2A and 2B, and will not be repeated here.

[0434] While the basic concepts have been described above, it will be apparent to those skilled in the art that the detailed disclosure is merely illustrative and does not limit this specification. Although not explicitly stated herein, various modifications, improvements, and revisions to this specification may be made by those skilled in the art. Such modifications, improvements, and revisions are suggested in this specification and remain within the spirit and scope of the exemplary embodiments of this specification.

[0435] This specification also uses specific terms to describe the embodiments of this specification. For example, "one embodiment," "an embodiment," and / or "some embodiments" refer to a feature, structure, or characteristic associated with at least one embodiment of this specification. Therefore, it should be emphasized and noted that references to "one embodiment," "an embodiment," or "an alternative embodiment" two or more times in different locations in this specification do not necessarily refer to the same embodiment. Furthermore, certain features, structures, or characteristics of one or more embodiments of this specification may be appropriately combined.

[0436] In addition, certain features, structures or characteristics in one or more embodiments of this specification may be appropriately combined, and all specific feasible combined technical solutions belong to the technical solutions disclosed in this specification.

Claims

1. An ophthalmic radiofrequency ablation system, characterized in that, Comprising: An ablation electrode, which includes an electrode needle with a tip and an operating handle. The electrode needle is mounted on the operating handle, and the tip is used to pierce the eye tissue to ablate the eye tissue based on radio frequency energy; A radio frequency ablation mainframe, which includes a power supply module, a control module, a radio frequency module, an input / output module, an impedance detection module, and an information reading module; wherein, The radio frequency module is configured to generate a radio frequency signal based on a control instruction sent by the control module to provide the radio frequency energy for the ablation electrode after the ablation electrode is electrically connected to the radio frequency ablation mainframe; The impedance detection module is configured to detect the impedance information of the eye tissue during ablation and transmit the impedance information to the control module; and The information reading module is configured to obtain the electrode information of the ablation electrode and transmit the electrode information to the control module after the ablation electrode is electrically connected to the radio frequency ablation mainframe, and / or write the usage information of the ablation electrode recorded by the radio frequency ablation mainframe into the ablation electrode; The power supply module is configured to supply power to the control module, the radio frequency module, the input / output module, and each module communicating with the control module.

2. The system according to claim 1, wherein The radio frequency module includes a radio frequency power supply, a radio frequency signal source, and a power amplification module, wherein, The radio frequency signal source is connected to the control module and is used to generate a radio frequency signal based on the control instruction of the control module; The power amplification module is connected to the radio frequency signal source and is used to generate radio frequency energy based on the radio frequency signal output by the radio frequency signal source; The radio frequency power supply is connected to the control module and the power amplification module and is used to provide electrical energy for the generation of the radio frequency energy.

3. The system according to claim 2, characterized in that, The radio frequency power supply includes a voltage adjustable power supply, which is configured to adjust the voltage to a target value based on an instruction sent by the control module so that the radio frequency module generates a radio frequency signal with a predetermined output power; Preferably, the radio frequency signal includes at least one of a weak electric waveform, a square wave, a sine wave, and a triangular wave, and the frequency of the radio frequency signal is in the range of 300 KHz - 3 MHz; Preferably, the power amplification module adopts a class D power amplification circuit; or adopts a power switch and a transformer, and the power switch and the transformer are connected in a circuit mode of a flyback topology, a push-pull topology, or a full-bridge topology; or adopts a circuit structure of a power amplifier cooperating with a transformer or an audio power amplifier circuit.

4. The system according to claim 1, characterized in that, The impedance detection module includes an impedance monitoring unit and a voltage-current feedback unit, wherein, The impedance monitoring unit is connected to the control module and the ablation electrode through an electrode connection switching unit and is used to monitor the impedance information of the eye tissue before and after the output of the radio frequency energy stops; The voltage-current feedback unit is used to monitor the impedance information of the eye tissue during the output of the radio frequency energy; The electrode connection switching unit includes a single-pole double-throw switch, which is used to switch the ablation electrode connected to the radiofrequency ablation host between being conducted to the radiofrequency module or the impedance detection module; wherein, Before or after the output of the radiofrequency energy, the single-pole double-throw switch is conducted to the impedance monitoring unit, so that the impedance monitoring unit monitors the impedance information of the eye tissue; When the output of the radiofrequency energy is turned on, the single-pole double-throw switch is conducted to the radiofrequency module, so that the radiofrequency module provides the radiofrequency energy for the ablation electrode.

5. The system according to claim 1, wherein The input / output module includes: A human-computer interaction unit, which is used to control the start and stop of the radiofrequency energy output, and / or set ablation parameters; and An output unit, which is used to display treatment information, electrode information, and / or prompt information to the user; Wherein, the human-computer interaction unit includes at least one of a foot switch, an activation switch, and an input button; the ablation parameters include at least one of the output power of the radiofrequency signal, the treatment time, and the treatment mode; Or, the output unit includes a display screen, the treatment information includes at least one of the treated time, the output power of the radiofrequency signal, and the real-time impedance, the electrode information includes at least one of the electrode type of the ablation electrode, the electrode expiration information, and the electrode life information, and the prompt information includes the accessory connection status and / or warning information; preferably, the electrode expiration information includes the production date, the production shelf life, the first use time, and a preset use time range after the first use, and the electrode life information includes the number of times of use and the remaining number of times of use, or the cumulative ablation duration and the remaining ablation duration.

6. The system according to claim 5, characterized in that, The treatment mode includes a continuous treatment mode and / or a single treatment mode. In the continuous treatment mode, multiple releases of radiofrequency energy can be performed after the tip of the electrode needle enters the eye tissue; The ophthalmic radiofrequency ablation system is configured to have a continuous output mode and / or a timed output mode, and the continuous output mode or the timed output mode reflects the output mode of the radiofrequency energy.

7. The system according to claim 6, wherein In the continuous output mode, starting the foot switch starts the output of the radiofrequency energy, and closing the foot switch or the activation switch stops the output of the radiofrequency energy; In the timed output mode, starting the foot switch starts the output of the radiofrequency energy and starts timing. When the timing reaches a preset time threshold, the output of the radiofrequency energy is automatically stopped. When the timing does not reach the preset time threshold but the foot switch or the activation switch is closed, the output of the radiofrequency energy is stopped.

8. The system according to claim 7, wherein In the continuous output mode or the timed output mode, each time the output of the radiofrequency energy is stopped, the radiofrequency ablation host records the usage information of the ablation electrode and updates the electrode life information of the currently used ablation electrode; preferably, the output of the radiofrequency energy further includes impedance judgment before output. When the impedance is zero or not within the preset impedance threshold range, the radiofrequency energy is not output.

9. The system according to claim 5, characterized in that, The attachment connection status includes whether the foot switch or the ablation electrode is connected or not connected to the radiofrequency ablation host; The warning information includes at least one of the following: electrode not connected, electrode unauthorized or verification failed, electrode life ended, electrode expired, foot switch not connected, self-check failed, please release the activation switch, please release the foot switch.

10. The system according to claim 1, wherein The control module includes a microcontroller unit, and the microcontroller unit is configured to have at least one function of pulse width modulation control, input / output, analog-to-digital conversion, read-only storage, random storage, flash memory, timing, and serial communication.

11. The system according to claim 1, wherein, The radiofrequency ablation host further includes at least one of the following: A power filter for suppressing noise in the AC power supply; A memory for storing ablation parameters; A real-time clock for providing time information for the radiofrequency ablation host.

12. The system according to claim 1, wherein The ablation electrode further includes a storage chip, and the storage chip is used to store at least one of the model, encryption information, electrode type, electrode expiration information, electrode life information, and data check code of the ablation electrode.

13. The system according to claim 12, wherein The expiration information includes the first use time, and the electrode life information includes the number of times used and the remaining number of times available. The first use time is actively written by the radiofrequency ablation host into the storage chip when the ablation electrode is first connected to the radiofrequency ablation host; The remaining number of times available and the number of times used are actively updated and written by the radiofrequency ablation host into the storage chip each time the ablation electrode is connected to the radiofrequency ablation host or the remaining number of times available and the number of times used of the electrode are updated after each radiofrequency output stops.

14. The system according to claim 1, characterized in that, When the ablation electrode is connected to the radiofrequency ablation host, the radiofrequency ablation host is configured to: Judge the availability of the ablation electrode based on the obtained electrode information; In response to the ablation electrode being unavailable, give a prompt through the input / output module; Or In response to the ablation electrode being available, display the electrode information through the input / output module and request the user to confirm.

15. The system according to claim 14, wherein The ablation electrode being available includes that the ablation electrode is an authorized electrode that has passed verification, has not exceeded the effective service life, and the remaining available life is not 0; further, in response to the user confirming the ablation electrode, the system recommends ablation parameters.

16. An ophthalmic radiofrequency ablation system, characterized in that, Including: A radiofrequency ablation host for providing radiofrequency energy; An attachment connected to the radiofrequency ablation host, and the attachment includes a foot switch and an ablation electrode; The foot switch is used to control the output and stop of the radiofrequency energy, and the ablation electrode is used to perform ablation based on the radiofrequency energy; Wherein, the ablation electrode includes: An electrode needle, the electrode needle is integrally cylindrical, and its cross-section sequentially includes an inner electrode, a first insulating layer, an outer electrode, and a second insulating layer from the inside to the outside in the radial direction. The outer surfaces of the front ends of the inner electrode, the first insulating layer, the outer electrode, and the second insulating layer respectively form an inner electrode region, a first insulating region, an outer electrode region, and a second insulating region. After the ablation electrode is connected to the radiofrequency ablation host, an ablation wave is generated between the inner electrode region and the outer electrode region; and Adjustment assembly, the adjustment assembly is inserted into the outer surface of the electrode needle and can move axially relative to the electrode needle for adjusting the length of the electrode needle exposed outside the adjustment assembly.

17. The system according to claim 16, wherein The ablation electrode further includes: an operating handle, and the electrode needle is mounted on the operating handle; Wherein, a first through hole is provided on the operating handle, the first through hole is a stepped hole with a stepped surface, the first through hole allows the rear end of the electrode needle to pass through and be fixed therein; the adjustment assembly is inserted into the first through hole and fixedly abuts against the stepped surface.

18. The system according to claim 17, wherein The ablation electrode further includes: Electrode needle protection cap, the electrode needle protection cap is a hollow conical structure for covering the electrode needle and being fixed around the end of the handle; a second through hole is provided on the electrode needle protection cap, and the second through hole connects the front and rear sides of the electrode needle protection cap opposite to each other to allow the adjustment tube to pass through the second through hole.

19. The system according to claim 16, wherein The radiofrequency ablation host includes a control module and an information reading module, wherein The information reading module is used for, after the ablation electrode is electrically connected to the radiofrequency ablation host, acquiring the electrode information of the ablation electrode and transmitting it to the control module; The control module is used for verifying the usability of the ablation electrode based on the electrode information and making parameter recommendations when the ablation electrode is available; Preferably, the control module is further used for detecting the connection status of the accessory and whether the foot switch is abnormally started, and giving a prompt when the accessory is not connected or the foot switch is abnormally started; the abnormal start of the foot switch includes the foot switch being started in a non-treatment interface.

20. The system according to claim 19, wherein The radiofrequency ablation host further includes an impedance detection module and a radiofrequency module; The impedance detection module is used for detecting impedance information during ablation and transmitting the impedance information to the control module; The control module is further used for judging whether the tip of the ablation electrode reaches the target position based on the impedance information and controlling the radiofrequency module to output radiofrequency energy in response to reaching the target position; Preferably, the control module is further used for, when the impedance suddenly changes, controlling the radiofrequency energy to stop output; or automatically stopping the output of the radiofrequency energy in response to the release of the foot switch or when the timing reaches the output duration of the radiofrequency energy.

21. An ocular radiofrequency ablation instrument, which is used to provide radiofrequency energy for an ablation electrode connected thereto, is characterized in that, The radiofrequency ablation instrument includes a control module, a radiofrequency module, an impedance detection module and an information reading module, wherein: The control module is used for communicating with the radiofrequency module, the impedance detection module and the information reading module to control the radiofrequency ablation instrument to generate the radiofrequency energy; The radiofrequency module is used for generating radiofrequency energy based on the control instruction of the control module; the radiofrequency module includes a radiofrequency power supply, a radiofrequency signal source and a power amplification module, wherein: The radiofrequency power supply is connected to the control module and the power amplification module for providing electrical energy for the generation of the radiofrequency energy; the radiofrequency signal source is connected to the control module and the power amplification module for generating a radiofrequency signal based on the control instruction; the power amplification module is used for generating an alternating current radiofrequency energy based on the radiofrequency signal and the electrical energy; The impedance detection module is used to detect impedance information before, during, or after the output of the radio frequency energy; The information reading module is used to obtain electrode information of the ablation electrode when the ablation electrode is connected to the radiofrequency ablation instrument.

22. The ophthalmic radiofrequency ablation instrument according to claim 21, wherein, The control module is further used for: Verifying the ablation electrode based on the electrode information obtained by the information reading module; Giving a prompt in response to the ablation electrode being unavailable; or In response to the ablation electrode being available, displaying the electrode type and electrode life information of the ablation electrode and requesting confirmation.

23. The ophthalmic radiofrequency ablation instrument according to claim 22, wherein, The ophthalmic radiofrequency ablation instrument further includes a foot switch interface for connecting a foot switch, and the control module is further used for: Detecting whether the foot switch is connected in response to the confirmation of the electrode type and electrode life information of the ablation electrode; Giving a prompt in response to the foot switch not being connected; and Entering a parameter setting interface in response to the foot switch being connected or the user clicking the confirmation button in the prompt interface.

24. The ophthalmic radiofrequency ablation instrument according to claim 23, wherein, The control module is further used for: in response to the confirmation of the electrode type and electrode life information of the ablation electrode by the user, making a recommendation for target parameters; preferably, based on the electrode type of the ablation electrode, recommending parameter values or a range of user-selectable parameters related to the target parameters; preferably, the target parameters include the output duration and output power of the radio frequency energy.

25. The eye radiofrequency ablation instrument according to claim 24, wherein, The ophthalmic radiofrequency ablation instrument further includes an activation switch, and the control module is further used for: Giving a prompt in response to the abnormal activation of the activation switch; The abnormal activation of the activation switch includes: the activation switch is activated when the first preset condition is not met, and the first preset condition includes that all functions of the radiofrequency ablation instrument are normal, the foot switch is connected, the ablation electrode is available, and the target parameters are determined.

26. The ophthalmic radiofrequency ablation instrument according to claim 25, characterized in that, The control module is further used for: Entering a treatment interface in response to the activation switch being activated when the first preset condition is met; The information displayed on the treatment interface includes at least one of electrode status, electrode type, electrode life information, output duration of radio frequency energy, real-time treatment time, output power of radio frequency energy, and impedance information; Preferably, the information displayed on the treatment interface includes electrode status, electrode type, electrode life information, output power of radio frequency energy, output duration of radio frequency energy, real-time treatment time, and real-time impedance.

27. The eye radiofrequency ablation instrument according to claim 26, wherein The control module is further used for: Giving a prompt in response to the abnormal activation of the foot switch; The abnormal activation of the foot switch includes: the foot switch is activated when the second preset condition is not met; the second preset condition includes that the radiofrequency ablation instrument enters the treatment interface.

28. A control method for a radiofrequency ablation instrument as described in any one of claims 21-27, characterized in that, The method includes: Detecting whether the functions of the radiofrequency ablation instrument are normal in response to the power-on of the radiofrequency ablation instrument; Detecting whether the ablation electrode connected to the radiofrequency ablation instrument is available in response to all functions of the radiofrequency ablation instrument being normal; Entering a parameter setting interface in response to the ablation electrode being available and the electrode information having been confirmed; Detecting whether the foot switch is connected in response to the ablation electrode being available before or after the confirmation of the electrode information; In response to the foot switch being connected and based on the target parameters recommended by or set in the parameter setting interface, control the output or stop of the radio frequency energy.

29. The method according to claim 28, wherein Detecting whether the functions of the radiofrequency ablation instrument are normal includes at least one of the following: Detecting whether the foot switch and / or the activation switch is abnormally activated; Detecting whether the status of the analog-to-digital converter of the radiofrequency ablation instrument is normal; Detecting whether the magnitude of the radiofrequency output frequency is normal; Detecting whether the real-time clock is accurate; Detecting whether the serial communication is normal; Detecting whether the power supply is normal; and Detecting whether the reading and writing of the memory are normal.

30. The method according to claim 29, characterized in that, The detecting whether the real-time clock is accurate includes: Comparing the time of the real-time clock with the latest device record time, and if the time of the real-time clock is before the device record time, determining that the real-time clock is inaccurate; and / or In response to the real-time clock being inaccurate, reminding the after-sales maintenance personnel to adjust the time.

31. The method according to claim 28, wherein The controlling the output or stop of the radio frequency energy based on the target parameters recommended by or set in the parameter setting interface further includes: In response to the activation switch being activated when a first preset condition is met, determining whether the ablation electrode has reached the target position; In response to the impedance information reaching a preset value or the ablation electrode reaching a predetermined depth, determining that the ablation electrode has reached the target position; and When the ablation electrode reaches the target position, in response to the foot switch being activated, controlling the output of the radio frequency energy based on the target parameters.

32. The method according to claim 31, wherein During the process of controlling the output or stop of the radio frequency energy, it further includes: when the impedance suddenly changes, controlling the radio frequency energy to stop output; or, in response to the foot switch being released, or the activation switch being turned off, or the timing reaching the output duration of the radio frequency energy, automatically stopping the output of the radio frequency energy.

33. A computer-readable storage medium, the storage medium stores computer instructions, and when a computer reads the computer instructions in the storage medium, the computer executes the control method according to any one of claims 28-32.

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