Ophthalmic radiofrequency ablation system

Abstract

An embodiment of the present specification provides an ophthalmic radiofrequency ablation system, including: an ablation electrode, including an electrode needle with a tip and an operating handle, the electrode needle is installed on the operating handle, and the tip is used to pierce the eye tissue; and a radiofrequency ablation host, including a control module, a radiofrequency module, an input / output module, an impedance detection module and an information reading module. Among them, the radiofrequency module is used to provide radiofrequency energy to the ablation electrode connected to the radiofrequency ablation host; the impedance detection module is used to detect the impedance information of the eye tissue during the ablation process; the information reading module is used to obtain the electrode information of the ablation electrode, and / or write the use information of the ablation electrode recorded by the radiofrequency ablation host into the ablation electrode. The ophthalmic ablation system provided in this embodiment can not only perform accurate radiofrequency ablation treatment on different eye tissues, simplify the user's operating steps and difficulty, but also determine whether the conditions for radiofrequency ablation are met to ensure the safety of the radiofrequency ablation treatment process.

Description

Technical Field

[0001] This specification relates to the field of eye treatment, and in particular to an ophthalmic radiofrequency ablation system. Background Art

[0002] 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.

[0003] Since the eye has a small tissue structure, it has higher requirements for the electrodes, ablation accuracy, clinical operability, treatment safety, etc. Therefore, it is hoped to provide an ophthalmic radiofrequency ablation system to achieve precise radiofrequency ablation of eye tissues and treat eye diseases such as glaucoma, while making clinical operations more convenient and safer. Summary of the invention

[0004] 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 , so as 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, when the ablation electrode is electrically connected to the RF ablation host, obtain the electrode information of the ablation electrode, 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.

[0005] 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 relative to the axial direction of the electrode needle, and is used to adjust the length of the electrode needle exposed from the adjustment component.

[0006] The ophthalmic radiofrequency ablation system provided in this embodiment, which includes an ablation electrode and a radiofrequency ablation host, can perform accurate radiofrequency ablation treatment on different eye tissues, while simplifying the user's operating steps and operating 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. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] This specification will be further described in the form of exemplary embodiments, which will be described in detail by the accompanying drawings. These embodiments are not restrictive, and in these embodiments, the same number represents the same structure, wherein:

[0008] Figure 1 is an exemplary schematic diagram of an ophthalmic radiofrequency ablation system according to some embodiments of the present specification;

[0009] Figure 2A and 2B is an exemplary schematic diagram of a host vehicle according to some embodiments of this specification;

[0010] Figure 3 is an exemplary schematic diagram of the hardware structure of a radiofrequency ablation host according to some embodiments of this specification;

[0011] Figure 4 is a schematic diagram of the hardware structure of an ophthalmic radiofrequency ablation system according to other embodiments of this specification;

[0012] Figure 5 is a software / hardware schematic diagram of a microcontroller unit according to some embodiments of the present specification;

[0013] Fig. 6A and 6B is an exemplary schematic diagram of a radiofrequency ablation host structure according to some embodiments of this specification;

[0014] Figure 7 is an exemplary schematic diagram of an ablation electrode according to some embodiments of the present specification;

[0015] Fig. 8A is an exemplary schematic diagram of an electrode needle according to some embodiments of this specification;

[0016] Figure 8B is an exemplary schematic diagram of the internal structure of an electrode needle according to some embodiments of this specification;

[0017] Fig. 9A is a schematic diagram of an embodiment of a regulating tube according to some embodiments of this specification;

[0018] Fig. 9B is a schematic diagram of another embodiment of the regulating tube according to some embodiments of this specification;

[0019] Fig.10 is a schematic diagram of another embodiment of the electrode needle according to some embodiments of this specification;

[0020] Fig.11 is a schematic diagram of an embodiment of an electrode needle according to some embodiments of this specification;

[0021] Fig. 12A is a schematic diagram of an embodiment of an electrode needle according to some embodiments of this specification;

[0022] Fig. 12B is a schematic diagram of another embodiment of the electrode needle according to some embodiments of this specification;

[0023] Fig.13 is a schematic diagram of an embodiment of an electrode needle according to some embodiments of this specification;

[0024] Fig.14 is an exploded schematic diagram of an ablation electrode according to some embodiments of the present specification;

[0025] Fig.15 is a cross-sectional view of the handle end of the ablation electrode according to some embodiments of the present specification;

[0026] Fig.16 is an exemplary schematic diagram of an electrode needle protection cap according to some embodiments of this specification;

[0027] Fig.17 is an exploded schematic diagram of an operating handle in an ablation electrode according to the present invention;

[0028] Fig.18 is an exemplary flow chart of an ophthalmic radiofrequency ablation method according to some embodiments of the present specification;

[0029] Fig.19 is an exemplary schematic diagram of an ophthalmic radiofrequency ablation method according to some embodiments of the present specification;

[0030] Fig. 20 is an exemplary schematic diagram of a display page for replacing electrodes according to some embodiments of this specification;

[0031] Fig.21 is an exemplary schematic diagram of a warning information display page according to some embodiments of this specification;

[0032] Fig. 22 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;

[0033] Fig.23 is a schematic diagram of a parameter setting page before treatment according to some embodiments of this specification;

[0034] Fig.24 is an exemplary schematic diagram of an information display page during a treatment process according to some embodiments of this specification;

[0035] Fig.25 is an exemplary schematic diagram of a system setting page according to some embodiments of this specification; and

[0036] Fig.26 is an exemplary schematic diagram of a time setting interface according to some embodiments of this specification. DETAILED DESCRIPTION

[0037] 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.

[0038] It should be understood that the "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 words can achieve the same purpose, the words can be replaced by other expressions.

[0039] As shown in this specification and claims, unless the context clearly indicates an exception, the words "a", "an", "an" and / or "the" do not refer to the singular and may also include the plural. Generally speaking, the terms "comprise" and "include" only indicate the inclusion of the steps and elements that have been clearly identified, and these steps and elements do not constitute an exclusive list. The method or device may also include other steps or elements.

[0040] When the operations are performed according to the step description in the embodiments of this specification, unless otherwise specified, the order of the steps is interchangeable, the steps may be omitted, and other steps may be included in the operation process.

[0041] Figure 1 is an exemplary schematic diagram of an ophthalmic radiofrequency ablation system according to some embodiments of the present specification.

[0042] like Figure 1 As shown, in some embodiments, the ophthalmic radiofrequency ablation system 100 may include a radiofrequency ablation host 110 , an ablation electrode 120 , and a connector 130 .

[0043] In some embodiments, the ablation electrode 120 may include an electrode needle with a tip and an operating handle. The electrode needle is mounted on the operating handle; the tip can be used to penetrate into the eye tissue to ablate the eye tissue based on radio frequency energy. The eye tissue refers to the tissue part that needs to be ablated by radio frequency. For example, the eye tissue may include the ciliary body, trabecular meshwork, iris and sclera. For more details about the ablation electrode, please refer to Figure 7-Figure 17 Described in.

[0044] The RF ablation host 110 is configured to provide RF energy to the ablation electrode after the ablation electrode is electrically connected to the RF ablation host. In some embodiments, the ablation host 110 may include a control module, a RF 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 RF module can be configured to generate an RF signal based on the control instruction sent by the control module after the ablation electrode 120 is electrically connected to the RF ablation host 110, so as to provide RF 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 change of impedance information (such as controlling the RF module to start or stop the output of RF energy, controlling the input / output module to output warning information, etc.). The information reading module can be configured to obtain the electrode information of the ablation electrode after the ablation electrode 120 is electrically connected to the RF ablation host 110, and transmit the electrode information to the control module so that the control module can determine whether the ablation electrode is available based on the electrode information. The information reading module can also be configured to write the usage information of the ablation electrode recorded by the RF ablation host 110 into the corresponding ablation electrode. For more details about the RF ablation host, please refer to Figure 3-6B Described in.

[0045] 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.

[0046] In some embodiments, the ophthalmic RF ablation system 100 may further include a foot switch. The foot switch may be connected to the RF ablation host 110 via a cable to control the output and stop of RF energy. For example, the foot switch may be connected to one end of the cable, and the other end of the cable may be plugged into a foot switch interface (such as a foot switch interface) on the RF ablation host 110. Fig. 6A Or the foot switch interface 664 in 6B), thereby electrically connecting to the RF ablation host 110. When the foot switch is electrically connected to the RF ablation host 110, if the RF 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 RF ablation host, etc.), the user can control the RF energy output by stepping on the foot switch, and release the foot switch to control the RF energy to stop outputting.

[0047] In some embodiments, Figure 2AAs shown in FIG. 2B , the ophthalmic RF ablation system 100 may further include a host trolley 140. The host trolley 140 is configured to carry the RF ablation host 110. In some embodiments, the RF ablation host 110 may be fixedly mounted or detachably mounted on the host trolley 140. When the RF ablation host 110 is mounted on the host trolley 140, the RF ablation host may be dragged and moved (e.g., moved to the user's location) by moving the trolley 140.

[0048] like Figure 2A As shown in Figure 2B, in some embodiments, the host trolley 140 may include a front handle 210, a rear push handle 220 and a storage box 230. The front handle 210 may be provided at the front end of the host trolley 140 to pull the host trolley, thereby driving the RF ablation host 110 installed thereon to move. The rear push handle 220 may be provided at the rear end of the host trolley 140 to push the host trolley 140 to move. The storage box 230 may be provided at the rear end bottom of the host trolley 140 to place items (such as cables, documents, masks, gloves, patient belongings, etc.). In some embodiments, the storage box 230 may also be provided at the front end or side of the host trolley 140. Among them, the front end of the host trolley may refer to the side where the display interface of the RF ablation host 110 is located after the RF ablation host 110 is installed on the trolley 140; accordingly, the rear end refers to the side opposite to the front end.

[0049] like Figure 2B As shown, in some embodiments, the host trolley 140 may further include a locking member 240 for fixing the RF ablation host. Figure 2B As shown in , the locking member 240 can be arranged above the platform 250 of the host trolley 140, and a knob connected to the locking member 240 is arranged at the bottom of the platform 250. A fixed structure (such as a fixed structure 650) matching the locking member 240 can be arranged on the RF ablation host, and the locking member 240 can be locked or unlocked with the fixed structure by rotating the knob, so that the RF ablation host 110 is fixed or separated from the host trolley 140. In some embodiments, the locking member 240 can include various reasonable shapes such as a cuboid, a cube, an irregular body, etc., and this specification does not make specific restrictions on this.

[0050] Figure 3 It is an exemplary schematic diagram of the hardware structure of the radiofrequency ablation host according to some embodiments of this specification.

[0051] like Figure 3 As shown, 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 .

[0052] The control module 113 is configured to control the RF ablation host 110 to perform RF ablation on eye tissue.

[0053] In some embodiments, the control module 113 can be connected to the RF module 112, the input / output module 114, the impedance detection module 115 and the information reading module 116 in the RF ablation host 110. The control module 113 can read information or send control instructions from the modules connected to it to realize the control of the RF ablation host 110. For example, the control module 113 can read the 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 the impedance information of the eye tissue detected by the impedance detection module 115, and determine whether the ablation electrode reaches the target position of the eye based on the impedance information. For another example, the control module 113 can receive the 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 it is available, the input / output module 114 (such as the display screen 610) is controlled to output the electrode information; if it is not available, the input / output module 114 is controlled to output a warning message (such as "electrode verification failed, please replace the electrode", "electrode life ends, please replace the electrode", etc.). 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 a prompt sound through the input / output module 114. For more information about this part, please refer to the following related description.

[0054] In some embodiments, the control module 113 may include a microcontroller unit (MCU). The microcontroller unit may be used to implement conversion between analog signals and digital signals, serial communication, SPI (Serial Peripheral Interface) communication, IIC (Inter-Integrated Circuit) communication, signal timing capture, timing control, identification of digital control states and logic control, and calculation of RF voltage and current. For more information about MCU, see Figure 5 Described in.

[0055] The RF module 112 may be configured to generate a RF signal based on a 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.

[0056] In some embodiments, Figure 4 As shown, the RF module 112 may include a RF signal source 1121 , a RF power supply 1122 , and a power amplification module 1123 .

[0057] The RF signal source 1121 is connected to the control module 113 and is used to generate a RF signal based on the control instruction of the control module 113. For example, the RF signal source 1121 can generate a RF signal of corresponding frequency and amplitude based on a signal generation instruction containing information such as frequency and amplitude sent by the control module 113. In some embodiments, the RF signal source 1211 can be connected to the control module 113 through a preset connection method. The preset connection method may include an electrical connection, a communication connection, etc.

[0058] 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 and 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 phase-locked loop-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.

[0059] In some embodiments, the RF 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.

[0060] In some embodiments, the radio frequency signal may include a weak current waveform, a square wave, a sine wave, and a triangle wave.

[0061] 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 80V, for example, 10V, 30V, 50V, 80V, etc.

[0062] In some embodiments, RF power supply 1122 may include a voltage adjustable power supply.

[0063] The voltage-adjustable power supply, also known as a voltage-controlled power supply, is configured to adjust the voltage to a target value based on the control instruction sent by the control module 113 so that the RF module 112 generates a RF signal with a predetermined output power. Exemplarily, 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 this ablation according to the output power of the RF signal, so that the electric energy output by the RF power supply 1122 can form the RF energy required for RF ablation through the power amplifier module.

[0064] 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.

[0065] The power amplifier module 1123 is connected to the RF signal source 1121 and is used to amplify the electric energy generated by the RF power supply 1122 to form RF energy based on the RF signal output by the RF signal source 1121. Figure 4 As shown, 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.

[0066] In some embodiments, the power amplifier module 1123 can form changing alternating current RF energy by amplifying the direct current generated by the RF power source under the RF signal output by the RF signal source.

[0067] In some embodiments, the power amplification module 1123 may include a class D power amplifier.

[0068] In some embodiments, the power amplifier module 1123 can generate radio frequency energy in a variety of ways. For example, the power amplifier module can generate radio frequency energy in a preset topology by means of a power switch in conjunction with a transformer. For another example, the power amplifier module can generate radio frequency energy by means of a power amplifier in conjunction with a transformer or in conjunction with an audio power amplifier circuit. Among them, the preset topology may include a flyback topology, a push-pull topology, and a full-bridge topology. The power switch may include a MOS tube, an IGBT, a Darlington transistor, and the like.

[0069] The input / output module 114 is configured to control the start and stop of RF energy output (such as by an activation switch, a foot switch, etc.), and / or set ablation parameters (such as by setting through a touch display screen), and display treatment information, electrode information and / or prompt information to the user (such as by displaying on a display screen).

[0070] In some embodiments, Figure 4 As shown, the input / output module 114 may include a human-computer interaction unit 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 instructions on ablation parameters, treatment information, electrode information and prompt information, please refer to the following related descriptions.

[0071] Ablation parameters refer to parameters used when performing radiofrequency ablation on eye tissue. In some embodiments, ablation parameters may include output power of radiofrequency signal, treatment time, treatment mode, etc.

[0072] Different eye tissues are targeted by radiofrequency ablation, and different electrode types are used. For example, for radiofrequency ablation of different eye tissues such as ciliary body, trabecular meshwork, iris, sclera, etc., the electrode types can be ciliary body electrodes, trabecular meshwork electrodes, iris electrodes, sclera electrodes, etc. When radiofrequency ablation is performed on different tissues, the ablation parameters are mainly the above parameters.

[0073] In some embodiments, the RF ablation host can automatically detect and identify, display the electrode type of the ablation electrode connected to the RF ablation host, and request user confirmation (see Fig.18 ) and recommends RF therapy parameters based on the electrode type. The RF ablation host automatically detects and identifies the connected electrode type, eliminating the need for operator selection, which is safer and can prevent the operator from selecting the wrong type.

[0074] 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 a plurality of 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.

[0075] In some embodiments, the alternative output power can be preset based on historical experience and the actual situation of the patient. For example, the alternative output power can be determined based on the output power of the radio frequency signal used in the completed radio frequency ablation process. In some embodiments, the alternative output power can have a range value (such as 0.5-9.9w), or multiple specific values.

[0076] The treatment time refers to the treatment time at a location after each insertion when performing radiofrequency ablation on eye tissue. In some embodiments, the treatment time can be obtained in a variety of ways. For example, in response to the availability of ablation electrodes, the control module 113 can provide a plurality of alternative treatment times according to the electrode type and control the input / output module 114 to display them on the display interface for user selection, or control the optional treatment time within the recommended range according to 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.

[0077] In some embodiments, the alternative treatment time can also be pre-set based on historical experience and the actual situation of the patient. For example, the alternative treatment time can be determined based on the treatment time used in the completed radiofrequency ablation process. In some embodiments, the alternative treatment time can be a time range (such as 1-20s, 10-100s, etc.), or multiple specific time values.

[0078] In some embodiments, the treatment mode may include a continuous treatment mode and / or a single treatment mode.

[0079] The continuous treatment mode means that after the tip of the electrode needle enters the eye tissue, the radiofrequency energy can be released multiple times at the same treatment position, that is, intermittently, and the corresponding treatment time is the accumulation of multiple release times. Correspondingly, the single treatment mode means that after the tip of the electrode needle enters the eye tissue, the radiofrequency energy is released once, and the corresponding treatment time is the release time of this radiofrequency energy.

[0080] In some embodiments, the treatment information may include elapsed treatment time, output power of the radio frequency signal, real-time impedance, etc.

[0081] The treatment time refers to the time that radiofrequency ablation has been performed at a radiofrequency ablation position. In some embodiments, the control module 113 can determine the treatment time through a timer and output it through the input / output module 114 (such as the display screen 610).

[0082] The real-time impedance can be used to characterize the real-time impedance of the eye tissue. For more information about the real-time impedance, please refer to the following related description.

[0083] 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 preset use 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 above-mentioned related descriptions. For more instructions on electrode validity period information and electrode life information, please refer to the following related descriptions.

[0084] In some embodiments, the prompt information may include accessory connection status and / or warning information.

[0085] Accessories refer to components that need to be connected to the RF ablation host through cables or other means. For example, accessories may include ablation electrodes 120, foot switches, etc.

[0086] The accessory connection state may represent the connection between the accessory and the RF ablation host. In some embodiments, the accessory connection state 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.

[0087] In some embodiments, control module 113 can automatically detect the accessory connection status and send the accessory connection status to input / output module 114 for display.

[0088] 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 a warning message of "electrode not connected" so that the user can check the connection status of the ablation electrode.

[0089] In some embodiments, the warning information may include electrode not connected, electrode not authorized or verification failed, electrode life ended, electrode expired, foot switch not connected, self-test failed, please release activation switch, please release 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 information "electrode not authorized". For more information about legal electrodes, please refer to the following related content.

[0090] 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 in a touch display screen), a real button, etc. In some embodiments, in response to the user setting the ablation parameter through the input button, the control module may determine the ablation parameter. The output unit may include a display screen (such as display screen 610), an audio device 430 (such as a speaker), etc.

[0091] 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.

[0092] The activation switch 450 is used to activate the RF module after the first preset condition is met. The first preset condition means that the accessory connection status between the accessory and the RF ablation host is connected, the ablation electrode is available, the ablation parameters have been set, and the RF ablation host has no other errors (all functions are normal). For instructions on the availability of the ablation electrode, please refer to the following related description.

[0093] 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.

[0094] 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 an off state, the control module will not send a control signal for RF output, and the RF energy output control cannot be achieved.

[0095] During the ablation 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.

[0096] In some embodiments, in response to the activation switch being abnormally activated (e.g., being activated when the first preset condition is not met) during the power-on self-test process or other non-RF output process, 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 display the warning message to prompt the user. The warning message may include, for example, "Please release the activation switch."

[0097] The foot switch is configured to control the start and stop of the radio frequency energy output after a second preset condition is met.

[0098] The second preset condition means 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 may be that the display interface enters the treatment interface.

[0099] In some embodiments, the connection method between the foot switch and the RF ablation host 110 may include cable connection or wireless network connection.

[0100] 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 outputs the warning message. The warning message may include, for example, "foot switch is not connected".

[0101] In some embodiments, in response to abnormal activation of the foot switch (such as being activated when the second 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 in the input / output module 114 outputs the warning message. The warning message may include, for example, "Please release the foot switch."

[0102] 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.

[0103] The continuous output mode means that in response to the user starting the foot switch, the control module 113 controls the RF module 112 to start outputting RF energy, and in response to the user turning off the foot switch or activating the switch, the control module 113 controls the RF module 112 to stop outputting RF energy. In some embodiments, the continuous output mode is suitable for performing multiple RF treatments on the same eye tissue.

[0104] 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.

[0105] The timed output mode means that in response to the user starting the foot switch, the control module 113 controls the RF module 112 to start outputting RF energy and start timing, and automatically stops the output of RF energy when the timing reaches a preset time threshold. In some embodiments, in response to the timing not reaching the preset time threshold, the user turns off the foot switch or activates the switch, and the control module 113 can control the RF module 112 to stop outputting RF energy. In some embodiments, the preset time threshold can be the treatment time or less than the treatment time.

[0106] In some embodiments, in the continuous treatment mode, when the RF ablation host starts to output RF energy and starts timing, the output unit 1142 in the input / output module 114 can display the real-time timing. In some embodiments, the output unit 1142 can simultaneously display the timing information, the number of treatments and / or the treatment time. In some embodiments, in response to restarting the timing after each timing is completed, the displayed real-time timing can be updated synchronously.

[0107] In some embodiments, in response to the user stepping on 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.

[0108] In some embodiments, in response to the foot switch not being released when the timing 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 outputs the warning message. The warning message may include "Please release the foot switch".

[0109] In some embodiments, in the continuous output mode or the timed output mode, each time the output of radio frequency energy is stopped, the radio frequency ablation host can record the use information of the ablation electrode and update the electrode life information of the currently used ablation electrode. For the description of the electrode life information, please refer to the following related description.

[0110] In some embodiments, the RF ablation host can determine the impedance of the eye tissue based on the impedance information obtained by the impedance detection module 115 before the RF energy is output. If the impedance of the eye tissue is 0 or is not within the preset impedance threshold range, the RF ablation host will not output RF energy even if the user activates the foot switch, which can further ensure 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 position to be treated, which can be preset.

[0111] The impedance detection module 115 is configured to detect the impedance information of the eye tissue during the ablation process and transmit the impedance information to the control module. For example, before the RF energy is output, in response to the user inserting the ablation electrode into the patient's eye tissue, the impedance detection module can detect the impedance information of the eye tissue. The impedance information can include real-time impedance.

[0112] In some embodiments, Figure 4 As shown, the impedance detection module 115 may include an impedance monitoring unit 1151 and a voltage and current feedback unit 1152 .

[0113] The impedance monitoring unit 1151 is configured to monitor the impedance information of the eye tissue before and after the RF energy output is stopped.

[0114] In some embodiments, the impedance monitoring unit 1151 may include a bio-impedance detection chip.

[0115] In some embodiments, the impedance monitoring unit 1151 can obtain the impedance information of the eye tissue and send the impedance information to the control module 113, and the control module 113 controls the input / output module 114 to display the impedance information of the eye tissue. The impedance information can help the user determine whether the tip of the ablation electrode is inserted into the position that needs to be treated (i.e., the target position).

[0116] In some embodiments, Figure 4 As shown, the impedance monitoring unit 1151 can be connected to the control module 113 and the ablation electrode 120 through the electrode switching unit.

[0117] 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, a switch circuit, and the like.

[0118] 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 .

[0119] In some embodiments, in response to the output of RF energy, the control module 113 may control the 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 .

[0120] 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.

[0121] The voltage and current feedback unit 1152 is configured to monitor the impedance information of the eye tissue during the output of the radio frequency energy.

[0122] In some embodiments, the voltage-current feedback unit 1152 may include a current-voltage sampling unit.

[0123] The current and voltage sampling unit is configured to collect feedback signals of current and voltage, and calculate impedance information based on the collected feedback signals of current and voltage. In some embodiments, the voltage and current feedback unit 1152 can send the collected current value and voltage value to the control module 113, and the control module 113 calculates the real-time impedance.

[0124] 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 in a variety of ways. For example, the current and voltage sampling unit can collect feedback signals of current and voltage, convert AC current and voltage signals into DC current and voltage signals through a rectifier circuit, and calculate impedance information through a resistance calculation formula. Among them, the resistance calculation formula includes Ohm's law formula.

[0125] 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, and the control module 113 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 of the treatment process. During the treatment process, the target tissue loses water and the impedance increases. The 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 changes suddenly (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.

[0126] 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.

[0127] 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 acquire the electrode information of the ablation electrode 120 and send it to the control module 113 .

[0128] 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 radio frequency ablation host into the ablation electrode.

[0129] In some embodiments, the ablation electrode 120 may include a memory chip. The memory chip is configured to store electrode information of the ablation electrode.

[0130] 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 encrypted 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 cumulative ablation time and the remaining ablation time.

[0131] The production date refers to the date when the ablation electrode leaves the factory. The production shelf life refers to the time from the production date to the expiration of the ablation electrode. The first use time refers to the time when the ablation electrode is first connected to the RF ablation host.

[0132] 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 opened 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 that the electrode has expired.

[0133] 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 actively write the first use time into the storage chip of the ablation electrode 120 .

[0134] 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 storage chip of the ablation electrode 120 by the RF ablation host 110 each time the RF ablation host 110 is connected. In some embodiments, in response to each use of the ablation electrode, the remaining number of uses in the storage chip is reduced by 1 and the number of uses is increased by 1.

[0135] 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 use of the ablation electrode, the accumulated ablation time in the storage chip can be increased by the time of a single ablation electrode use, and the remaining ablation time can be reduced by the time of a single ablation electrode use.

[0136] 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 RF ablation host (such as the remaining number of uses, the number of uses, etc.) into the storage chip.

[0137] In some embodiments, the storage chip can be integrated inside the electrode operating handle, or integrated into the plug of the aviation plug cable connecting the electrode operating handle and the radiofrequency ablation host.

[0138] In some embodiments, the RF ablation host 110 may determine whether the ablation electrode is available based on the acquired electrode information.

[0139] Ablation electrode availability means that the ablation electrode is a legal electrode, has not exceeded the effective use period, and the remaining usable life (remaining number of uses or remaining ablation time) is not 0. Legal electrode refers to an authorized electrode that has passed verification and is compatible with the RF ablation host. The effective use period can include the production shelf life and the preset use time range.

[0140] 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 is determined that the ablation electrode is a legally authorized electrode. At the same time, it is checked 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 is determined that the ablation electrode is available. Among them, the encryption information can be constructed in a variety of ways, such as 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 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."

[0141] 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".

[0142] 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 has expired", etc.

[0143] In some embodiments, in response to the ablation electrode being available, the control module 113 may send the electrode information to the input / output module 114 to control the input / output module 114 to output the electrode information for confirmation by the user. Fig. 22 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, such as Fig. 22 As shown, when the connected ablation electrode is available, the control module 113 can control the display interface of the display screen 610 to display Fig. 22 The electrode type, electrode life and other information shown in the display interface 2000 are displayed. If the electrode type and electrode information are correct, the user can click the "Confirm" button in the display interface 2000 to confirm and enter the next step.

[0144] In some embodiments, Figure 3 As shown, the RF ablation host 110 may further include a power module 111 .

[0145] The power module 111 is configured to supply power to the control module 113 , the RF module 112 , the input / output module 114 , and various modules communicating with the control module 113 .

[0146] 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.

[0147] 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.

[0148] In some embodiments, the power module 111 may include multiple power submodules. The multiple power submodules may respectively power multiple modules in the RF ablation host 110. Figure 4 As shown, the power submodule 1111 can provide power for the output unit 1142, and the power submodule 1112 can provide power for the control module 113 and the modules electrically connected to the control module 113 (such as the impedance detection unit 1151, the voltage and current feedback unit 1152, the information reading module 116, etc.).

[0149] It is understandable that by independently supplying power to the modules corresponding to the power submodule through the power submodule, the power supply stability of the radiofrequency ablation host can be improved without causing mutual power supply interference.

[0150] In some embodiments, Figure 4 As shown, 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 .

[0151] The 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 is understood that the power filter can attenuate the EMI noise introduced with the AC power supply, while effectively suppressing the EMI noise generated by the power equipment to prevent it from entering the AC power grid and interfering with other electronic devices.

[0152] The 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, electrode information. For another example, the memory may store alternative output powers and alternative treatment times, etc.

[0153] In some embodiments, the memory 420 may include a large capacity memory, a removable memory, etc., or any combination thereof. Preferably, the memory 420 may be an electrically erasable programmable read only memory (EEPROM). By using an EEPROM memory, data can be retained after the device is powered off or shut down, thereby avoiding data loss. In some embodiments, the memory 420 may be integrated into the control module 113 or other modules of the RF ablation host 110.

[0154] The audio device 430 may be configured to emit audio information. In some embodiments, the audio information may include audio warning information, prompts, etc. For example, when the control module 113 detects that the activation switch is abnormally started (i.e., started when the first preset condition is not met), the audio device 430 may voice broadcast the warning message "Please release the activation switch". For another example, when the control module 113 detects that the ablation electrode is disconnected, a beeping prompt sound may be emitted through the audio device 430. In some embodiments, the audio device 430 may be integrated into the RF ablation host 110.

[0155] 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. Fig.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. The after-sales maintenance personnel or technicians can use the engineering electrode to Fig.26 The time setting page shown is used for setting. Engineering electrodes are a type of ablation electrodes, and the control module can determine whether it is an engineering electrode in a variety of ways. It is understandable that the radiofrequency ablation instrument can calculate the life of the ablation electrode based on the system time, and the radiofrequency 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.

[0156] Figure 5 is a software / hardware schematic diagram of a microcontroller unit according to some embodiments of the present specification.

[0157] In some embodiments, the microcontroller unit can be configured to have at least one of pulse width modulation control, input / output, analog-to-digital conversion, read-only storage, random access storage, flash memory, timing, and serial communication. Figure 5 As shown, the microcontroller unit may include a processor 510, a flash memory 520, a read-only memory 530, a random access memory 540, an input / output port 550, a communication port 560, an analog-to-digital converter 570, and a timer 580. These components may be connected via a bus to transmit information to implement related functions.

[0158] 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 a 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.

[0159] 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.

[0160] The communication port 560 can perform serial communication, SPI communication, IIC communication, and the like.

[0161] The analog-to-digital converter 570 may be used to convert between analog signals and digital signals.

[0162] 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.

[0163] Fig. 6A and 6B It is an exemplary schematic diagram of the radiofrequency ablation host structure shown in some embodiments of this specification.

[0164] In some embodiments, Fig. 6AAs shown, in addition to the above hardware modules (such as power module 111, RF module 112, control module 113, input / output module 114, impedance detection module 115, information reading module 116, etc.) and power filter 410, memory 420, audio device 430, real-time clock 440, activation switch 450 and other structures, the RF ablation host 110 can also include a rotating handle 620, a cooling fan 630, a mainboard 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.

[0165] The rotating handle 620 can be installed on the upper part of the RF ablation host 110 for taking and placing the RF ablation host. In some embodiments, the rotating handle 620 can be provided with a handle protrusion so that when the rotating handle falls, it can slowly contact the handle groove at the corresponding position on the RF ablation host 110 to avoid colliding with the RF ablation host 110. In some embodiments, the rotating handle 620 can be connected to the RF ablation host 110 through a rotating shaft, and the rotating handle 620 can rotate along the rotating shaft (such as rotating 0-180 degrees, 0-90 degrees, 0-160 degrees, etc.).

[0166] 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 electromagnetic interference from the outside to the inside of the RF ablation host or from 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.

[0167] In some embodiments, the connector socket 661 can be arranged on the side where the display screen of the RF ablation host is located (also called the front side), and is used to connect the connector 130 to achieve the connection between the ablation electrode 120 and the RF ablation host 110. By arranging the connector interface on the side where the display screen of the RF ablation host is located, it is convenient for the user to view the information displayed on the display screen (such as electrode information, treatment information, warning information, etc.) during the ablation process.

[0168] like Figure 6B As shown, the power switch and the interface 662 may be disposed on the back side of the RF ablation host (the side opposite to the display screen) for connecting the RF ablation host 110 to an external power source.

[0169] like Figure 6B As shown, the equipotential interface 663 can be set 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.

[0170] like Figure 6B As shown, the foot switch interface 664 can be set on the back of the radiofrequency ablation host to connect the foot switch to the radiofrequency ablation host 110.

[0171] By arranging the power switch and interface 662, equipotential interface 663 and foot switch interface 664 on the back of the RF ablation host, the appearance of the host can be improved while being used, while preventing the devices connected to the interface from affecting the user's viewing of the display information on the display screen.

[0172] In some embodiments, Figure 6B As shown, the RF ablation host 110 may further include a fixing structure 650 for fixing on the host trolley 140. In some embodiments, the fixing structure 650 may be a structure matching the locking member 240. For example, the fixing structure 650 may be a rectangular groove, which has the same shape as the locking member 240 and can accommodate the locking member 240. The locking member 240 rotates a certain angle in the groove to achieve locking and fixing of the RF ablation host.

[0173] Figure 7 is an exemplary schematic diagram of an ablation electrode according to some embodiments of the present specification.

[0174] 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 .

[0175] like Figure 7 and Fig. 8A As shown, in some embodiments, the ablation electrode 120 may include an electrode needle 1 with a tip 2 and an operating handle 4, and the electrode needle 1 is mounted on the operating handle 4. The tip 2 is configured to penetrate into the eye tissue to ablate the eye tissue based on radio frequency energy. In some embodiments, the ablation electrode 120 may include an adjustment component 3 and an electrode needle protective cap 6.

[0176] The electrode needle 1 may 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 may generate ablation waves using radiofrequency energy provided by the radiofrequency ablation host 110.

[0177] In some embodiments, Fig. 8A or Figure 8B As shown, the electrode needle 1 is cylindrical in shape as a whole, and includes an electrode inner pole 21 , an electrode outer pole 23 , and an insulating structure. The insulating structure may include a first insulating layer 22 and a second insulating layer 24 .

[0178] In some embodiments, the cross-section of the columnar structure along the radial direction of the electrode needle from inside to outside is 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 is the same straight line.

[0179] 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.

[0180] In some embodiments, the constituent material of the inner pole may include tungsten, platinum, platinum-iridium alloy, etc. The constituent material of the outer pole may include stainless steel, titanium alloy, for example, 2Cr13, 1Cr13, TC4, etc. The constituent material of the insulating structure may include polyimide, polyetheretherketone, ceramic, parylene, PTFE, glass, ABS, PC, POM, etc.

[0181] 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 generatrix 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.

[0182] In some embodiments, when the ablation electrode 120 is connected to the radiofrequency ablation host 110 , an ablation wave is generated between the inner pole region and the outer pole region of the ablation electrode 120 .

[0183] The operating handle 4 is configured to control the position of the ablation electrode. Figure 7 , Fig.14 , Fig.15 As shown, the operating handle 4 may be slender, including a handle end 41 and a handle body 42, and the handle end 41 and the handle body 42 may be connected in a detachable manner to facilitate the replacement of different handle ends 41 of the operating handle 42. The detachable connection may include plug-in, snap-on, screw-on, etc.

[0184] 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.

[0185] In some embodiments, the handle end 41 may be tapered and may have a circular 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 is the front end of the handle end, and the end with the larger cross section diameter is the rear end of the handle end.

[0186] In some embodiments, a first annular flange 411 may be provided at a preset position between the front end and the rear end of the handle end 41. The preset position may include the middle portion of the handle end.

[0187] In some embodiments, the first annular flange 411 may form abutment portion 412 with the rear side of the handle end. The butt portion 412 may be used for the middle finger to butt against, to prevent the finger from slipping when using the operating handle, and to improve the comfort of the hand holding the operating handle. In some embodiments, the diameter of the cross section of the butt portion may first gradually decrease and then gradually increase in the direction from the first annular flange to the rear end of the handle end.

[0188] 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 a detachable connection such as plug-in, snap-on, screw-on, etc.).

[0189] 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 further extends toward the rear side of the handle end 41, and the handle end 41 is detachably connected to the handle body 42 through the positioning sleeve 413. For example, one of the positioning sleeve 413 and the handle body 42 is provided with a first positioning groove 414, and the other of the positioning sleeve 413 and the handle body 42 is provided with a positioning protrusion 421 that matches the first positioning groove 414.

[0190] In some embodiments, the positioning sleeve 413 is provided with a plurality of first positioning grooves 414 in the circumference thereof, and the handle body 42 is provided with a plurality of positioning protrusions 421 corresponding to the first positioning grooves 414, and the positioning protrusions 421 can be inserted into the first positioning grooves 414 to fix the handle end 41 to the handle body 42. Preferably, there can be two first positioning grooves 414, which are symmetrically arranged along the circumference of the positioning sleeve 413.

[0191] In some embodiments, a plurality of positioning protrusions may be provided around the positioning sleeve 413, and a plurality of first positioning grooves matching the positioning protrusions may be provided inside the handle body 42 correspondingly. The positioning protrusions may be inserted into the first positioning grooves to fix the handle end 41 to the handle body 42.

[0192] In some embodiments, a counterweight cavity 45 may be provided inside the positioning sleeve 413, and a counterweight block 46 may be inserted into the cavity 45. The counterweight block 46 may improve the user's operating feel. The counterweight block 46 is a tubular structure, and a plurality of second positioning grooves 47 corresponding to the first positioning groove 414 are also provided around the counterweight block 46. After the positioning protrusion 421 is inserted through the first positioning groove 414, it is further inserted into the second positioning groove 47, thereby strengthening the fixed connection between the handle end 41 and the handle body 42, and also preventing the counterweight block 46 from being separated from the counterweight cavity 45.

[0193] In some embodiments, Fig.15 As shown, the length of the electrode inner pole 11 in the axial direction can be greater than the length 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 storage chip 5 inside the operating handle 4 through 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 one end of the electrode needle 1 located inside the operating handle 4 to expose the electrode outer pole 13, and the electrode outer pole 13 is electrically connected to the storage chip 5 through a connecting wire. The connecting wire and the storage chip 5 can be electrically connected by welding, such as micro-resistance welding, laser welding, brazing, etc.

[0194] In some embodiments, the handle body 42 may be in the shape of an elongated 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.

[0195] In some embodiments, the front end of the handle body may be provided with a second annular flange 422, and a grip portion 423 is formed between the second annular flange 422 and the rear end of the handle body 42. The cross section of the grip portion 423 is circular, and the cross-sectional size of the grip portion 423 gradually decreases and then gradually increases in the direction from the second annular flange 422 to the rear end of the handle body 42. The grip portion 423 can be used for gripping by the thumb and index finger of the hand to improve the comfort of the hand gripping the operating handle.

[0196] In some embodiments, the handle body 42 may include a left shell 8, a right shell 9, and an upper shell 7. In some embodiments, the left shell 8 and the right shell 9 may have the same and symmetrical structures and be connected in a detachable manner. In some embodiments, the upper shell 7 may be inserted into the opening formed by the left shell 8 and the right shell 9.

[0197] In some embodiments, in combination Fig.14 , Fig.17 As shown, the top middle area of ​​the left shell 8 and the right shell 9 can each be provided with an opening 75 to allow the upper shell 7 to be inserted into the mounting groove 76 formed by the two openings 75. Preferably, the opening 75 can be an arc-shaped opening so that the shape of the opening 75 is more compatible with the cross-sectional change of the handle body 42.

[0198] In some embodiments, a first fixed block 71 may be provided at the bottom of the upper shell 7 near the front end, and a first fixed slot 77 may be provided on the lower side of the front end of each opening 75. The first fixed block 71 can be inserted and fixed in a first fixed hole 78 formed by the two first fixed slots 77, that is, the front end of the upper shell 7 can be engaged in the first fixed hole 78 through the first fixed block 71.

[0199] 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 matching the plug-in card block 72 may be provided on the lower side of the middle part of the opening 75, and 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 blocks 72.

[0200] 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 a 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.

[0201] In some embodiments, a mounting protrusion 73 may be provided in the middle area of ​​the bottom of the upper housing 7, and the mounting protrusion 73 is integrally formed with the plug-in card blocks 72 on both sides. The lower surface of the mounting protrusion 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.

[0202] 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 storage chip 5 to pass through.

[0203] The adjustment component 3 is configured to be inserted into the outer surface of the electrode needle 1 and can move relative to the axial direction of 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.

[0204] 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 and prevent the adjustment tube from penetrating the eye tissue.

[0205] It is understood that the length of the electrode needle 1 exposed from the adjustment tube 3 is the depth of the electrode needle 1 penetrating the eye tissue. In some embodiments, the depth of the electrode needle penetrating the eye tissue may include 0.5mm to 2.5mm. For example, 0.5mm, 0.7mm, 1.1mm, 1.5mm, 2.5mm, etc. Among them, the depth of the electrode needle penetrating the eye tissue can be determined based on the use requirements.

[0206] In some embodiments, the adjustment tube 3 may include adjustment tubes of different lengths, and the lengths of the electrode needles exposed from the adjustment tubes are different. For example, if the depth of the electrode needles penetrating the eye tissue changes from 1.5 mm to 2.5 mm, a 1 mm shorter adjustment tube is required compared to the previous adjustment tube.

[0207] In some embodiments, the adjusting tube 3 can be installed on the adjusting handle 4 in a variety of ways. For example, the adjusting tube can be fixed to the operating handle by magnetic attraction. For example, the adjusting tube can be fixed to the operating handle by plugging.

[0208] In some embodiments, Fig. 9A As shown in FIG. 9B , a numerical mark 31 is provided on the outer surface of one end of the regulating tube, and an in-position mark 32 is provided on the outer surface of the other end. The numerical mark 31 can represent the length of the electrode needle exposed from the regulating tube. For example, the numerical mark 2.5 mm indicates that the length of the electrode needle exposed from the regulating tube is 2.5 mm. The in-position mark 32 can represent that the regulating tube is inserted to a position where it can be fixedly connected to the operating handle.

[0209] 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.

[0210] The electrode needle protection cap 6 is configured to protect the electrode needle. Fig.16 As shown, the electrode needle protection cap 6 can be a hollow conical structure, covering and fixed on the periphery of the handle end 41.

[0211] In some embodiments, the electrode needle protection cap 6 may be provided with a second through hole 61, which connects the front and rear 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 through hole 62 that penetrates the electrode needle protection cap 6 in the radial direction of the electrode needle protection cap 6 and extends along the axial direction.

[0212] In some embodiments, a preset number of strip-shaped clamping arms 63 may be formed in the strip-shaped through hole 62, and the free end of each strip-shaped clamping arm 63 extends toward the direction close to the second through hole 61. The strip-shaped clamping arm 63 can clamp the adjusting tube 3 after elastic deformation. The preset number may include 2.

[0213] In some embodiments, the strip-shaped clamping arms 63 can be symmetrically arranged with respect to each other, and protruding clamping portions 631 are arranged on the inner sides facing each other of the two strip-shaped clamping arms 63, 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.

[0214] In some embodiments, the adjusting tube 3 can be inserted with the help of the electrode needle protective cap 6. The specific operating steps for installing the adjusting tube 3 are as follows: the operator selects the required model of the adjusting tube 3, inserts the selected adjusting 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 adjusting tube 3 centrally, and forms a guide channel to guide the adjusting tube 3 to align with the first through hole 43 of the insertion operating handle 4, thereby realizing the rapid insertion of the adjusting tube 3.

[0215] In some embodiments, the electrode needle protective cap 6 can be used to freely replace the adjustment tube 3 of different lengths, 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.

[0216] In some embodiments, the ablation electrode 120 may include three or more electrode needles, wherein one of the three or more electrode needles is located at the center of the ablation electrode 120 as an inner electrode pole, and the remaining electrode needles are arranged around the one electrode needle as outer electrode poles, and the insulating structure is arranged between the inner electrode pole and the outer electrode pole.

[0217] Please refer to Fig.10 , Fig.10 An example of an ablation electrode including three or more electrode needles is shown in FIG. Fig.10As shown in the figure, taking the case of a device including five electrode needles, the front end of the ablation electrode 120 is a conical structure, an electrode inner pole 1021 can be arranged at the tip of the conical structure, and four electrode outer poles 1023 are arranged around the electrode inner pole 1021 on the conical surface of the conical structure, and the rest between the electrode inner pole 1021 and the four electrode outer poles 1023 is a cast insulating structure. It can be understood that Fig.10 The above is only used as an example. In some embodiments, the outer periphery of the electrode inner pole 1021 may be provided with any number of electrode outer poles, such as 3, 5, 6, 7, etc. In some embodiments, the multiple electrode outer poles may form a regular or irregular shape such as a triangle, a quadrilateral, a pentagon, etc. in the cross section of the ablation electrode. In some embodiments, the electrode inner pole 1021 may be located at a non-central position of the multiple electrode outer poles, such as near the left side or near the right side. In some embodiments, the constituent material of the insulating structure may be the same as that of the above Fig. 8A The insulating structures in the electrode needles 1 shown are made of the same material.

[0218] In some embodiments, Fig.10 The tip of the ablation electrode 120 shown can be formed by grinding. During the grinding process, the tip of the conical needle tip is formed by the inner electrode 1021, and the outer electrode 1023 on the conical surface is exposed during grinding. Fig.10 The diameter size range of the inner electrode and the outer electrode of the ablation electrode 120 shown may include 0.1-0.3 mm, and the overall size of each electrode needle may be the same as the above-mentioned electrode needle 1.

[0219] 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.

[0220] See also Fig.11 , the figure shows a schematic diagram of an ablation electrode including an even number of electrode needles. Fig.11 As shown, the ablation electrode 120 can be composed of an even number of electrode needles (such as 4, 6, 8, 10, etc.), and half of the electrode needles in the even number of electrode needles are electrode positive electrodes 11-1, and the other half of the electrode needles are electrode negative electrodes 11-2. The electrode negative electrodes 11-2 and the electrode positive electrodes 11-1 can be arranged alternately and spaced, and the insulating structure can be sleeved on the periphery of each electrode needle.

[0221] 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 Fig.11 The structure of the operating handle or housing of the ablation electrode shown may be different from Figure 7 The structure of the operating handle is shown. 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 ablation waves. The spacing range of the electrode needles arranged at intervals may include 0.3-0.9mm.

[0222] In some embodiments, Fig.11 The size range and constituent materials of the even-numbered electrode needles in the ablation electrode 120 shown 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.

[0223] In some embodiments, the ablation electrode 120 may include an electrode needle, 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.

[0224] Please refer to Fig. 12A and 12B , the figure shows an ablation electrode with a stepped electrode needle. Fig. 12A and 12B As shown, 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, 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.

[0225] like Fig. 12AAs shown, in some embodiments, at the connection between the tip of the electrode needle 12 and the insulating structure 1222, a boss 1224 protruding from the outer surface of the electrode outer pole 1523 may be formed along the radial direction of the electrode needle. The boss 1224 may be disc-shaped and attached to the patient's ocular surface during ablation. In some embodiments, the boss 1223 may 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) may 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 may be in the range of 0.5-1.8 mm.

[0226] like Fig. 12B As shown, 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 eye surface.

[0227] 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 subjected to radiofrequency ablation in the form of a patch.

[0228] In some embodiments, the ablation electrode 120 may include a sandwich electrode needle 13, which includes an electrode positive electrode, an electrode negative electrode, and an insulating layer disposed between the electrode positive electrode and the electrode negative electrode in a radial direction, wherein the insulating layer forms the tip of the electrode needle. In some embodiments, the sandwich electrode needle 13 may be an electrode needle of a special-shaped structure, or a regular cylindrical structure electrode needle with a conical tip.

[0229] Please refer to Fig.13 , the figure shows the ablation electrodes stacked in the radial direction of the ablation electrodes. Fig.13 As shown, the electrode needle 13 may be a non-cylindrical structure and a non-conical tip. In some embodiments, the electrode needle 13 may include a first pole 1311, a second pole 1312, and an insulating interlayer 1313 (i.e., an insulating structure) disposed between the first pole and the second pole along the radial direction. The first pole 1311 and the second pole 1312 are respectively the positive electrode and the negative electrode. For example, the first pole is the positive electrode, and the second pole is the negative electrode; or the first pole is the negative electrode, and the second pole is the positive electrode. In some embodiments, the first pole 1311, the second pole 1312, and the insulating clip 1313 may 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) may 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 may be in the range of 0.3-1.5 mm.

[0230] In some embodiments, the constituent material of the insulating structure may include glass, ceramic, basalt, etc. The constituent materials of the first pole and the second pole are the same as those of the electrode needle 1 described above.

[0231] In some embodiments, the electrode needle 1, electrode needle 11, electrode needle 12, and electrode needle 13 can be formed into an insulating structure or an insulating structure and an electrode outer pole in a variety of ways. For example, the electrode needle can form an insulating structure or an insulating structure and an electrode outer pole by means of a coating layer, and form an electrode tip by grinding. For example, the electrode needle can form an insulating structure and a metal electrode outer pole on the needle tip surface of the electrode inner pole by means of vapor deposition and electroplating; in addition, it should be understood that the electrode outer pole and the electrode inner pole in this specification are respectively used as the positive pole and the negative pole during the radiofrequency ablation process, that is, when the inner pole is a positive pole, the outer pole will be a negative pole, or when the inner pole is a negative pole, the outer pole will be a positive pole.

[0232] As mentioned above, the radiofrequency ablation system of the present invention can achieve radiofrequency ablation of eye tissues such as 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 a curved needle with a straight tip.

[0233] In some embodiments of the present specification, the ophthalmic radiofrequency ablation system can complete the radiofrequency ablation operation more safely and conveniently, and can recommend corresponding treatment plans according to different treatment sites, and can achieve precise radiofrequency ablation of eye tissues such as the ciliary body, trabecular meshwork and iris.

[0234] It should be understood that Figure 1 The ophthalmic radiofrequency ablation system and its modules shown can be implemented in various ways. It should be noted that the above description of the ophthalmic radiofrequency ablation system and its modules is only for the convenience of description and cannot limit this specification to the scope of the embodiments. It is understandable that for those skilled in the art, after understanding the principle of the system, it is possible to arbitrarily combine the modules or form a subsystem to connect with other modules without deviating from this principle. In some embodiments, Figure 1 The control module, radio frequency module, input / output module, impedance detection module and information reading module disclosed in the specification can be different modules in a system, or one module can realize the functions of two or more modules mentioned above. For example, each module can share a storage module, or each module can have its own storage module. Such variations are all within the protection scope of this specification.

[0235] Fig.18 is an exemplary flow chart of an ophthalmic radiofrequency ablation method according to some embodiments of the present specification. Fig.19 FIG. 1 is an exemplary schematic diagram of an embodiment of an ophthalmic radiofrequency ablation method according to some embodiments of this specification. Fig.18 As shown, process 1800 may include the following steps:

[0236] Step 1810, in response to the radiofrequency ablation system being turned on, detecting whether the radiofrequency ablation system functions normally.

[0237] Turning on the device may refer to starting the RF ablation host by pressing a button or other means (such as voice, etc.). Fig.19 As shown, before starting up, you can first perform pre-startup preparations, such as connecting a power source, connecting a foot switch, etc. In some embodiments, after starting up, it is possible to automatically detect whether each function of the radiofrequency ablation system is normal.

[0238] In some embodiments, detecting whether the function of the RF ablation system 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 state 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.

[0239] In some embodiments, in response to a module in the RF ablation host that cannot operate normally, the 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.

[0240] like Fig.25 As shown, in some embodiments, in response to the RF ablation system being turned on and all modules functioning normally, the interactive interface 2000 may display a system settings page, including touch key prompt sound on / off, screen brightness adjustment, system time setting, etc. Among them, the touch key prompt sound can be selected by touching the on / off selection button. The screen brightness can be selected by sliding the node on the right line. The system time can be selected by Fig.21 Set the input box shown, for example, to 11:19 on October 8, 2023.

[0241] like Fig.26As shown, in some embodiments, in response to the first use of the radiofrequency ablation system, the interactive interface 2000 can display a time setting page. 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 confirmation button. Among them, enter the correct year, month, day, hour, minute and week in the input box 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 electrode information (such as when the information is incorrect), rewrite it, or perform other background settings.

[0242] 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 authority is not open to the user.

[0243] 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.

[0244] 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 time of the real-time clock device. At this time, the user does not need to set the real-time clock device.

[0245] The medical management system refers to a system used by the hospital to manage or process data on various aspects of medical information. For example, the medical management system may include an outpatient and emergency management system, a medical record management system, a medical statistics query system, etc. In some embodiments, after the radiofrequency ablation system is connected to the medical management system network, it may have a patient management function. For example, the radiofrequency ablation system is connected to a camera, and the camera scans the code to input patient information; the patient is managed by retrieving more patient information (such as medical records, consultation time) from the medical management system. In some embodiments, the patient management function also includes data analysis, formulating patient review plans, and reminding patients to review.

[0246] In some embodiments, the radiofrequency ablation system can obtain treatment information of different patients (such as the single radiofrequency treatment time, total treatment time, output power of radiofrequency energy, etc. of different patients) 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 big data analysis. Exemplarily, 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 patient, and the big data model outputs the corresponding recommended ablation parameters (treatment time, output power of radiofrequency energy, etc.).

[0247] In some embodiments, when each module of the RF ablation host is normal, it can detect whether the RF energy control switch of the RF ablation system is functioning normally. In some embodiments, the RF energy control switch may 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 normally, the interactive interface 2000 may display a warning message. The warning message may include, for example, "Please release the activation switch", "The foot switch is not connected", "Please release the foot switch", etc. For more information about the warning message, see Figure 1 And its related description. In some embodiments, when the RF ablation system is turned on and the ablation electrode is not connected, the user activates the foot switch or the activation switch. If a warning message (such as "Please release the foot switch" or "Please release the activation switch") appears on the interactive interface 2000, it can be considered that the RF energy control switch of the RF ablation system is functioning normally. For example, when the first preset condition is not met, the user activates the activation switch. If a warning message (such as "Please release the activation switch") appears on the interactive interface 2000, it can be considered that the activation switch of the RF ablation system is functioning normally. 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 RF ablation system is functioning normally.

[0248] Step 1820: In response to all functions of the radiofrequency ablation system being normal, detecting whether the ablation electrode connected to the radiofrequency ablation host is available.

[0249] 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 electrode information, information reading module, and control module, please refer to Figure 1 The related descriptions will not be repeated here.

[0250] In some embodiments, the electrode information of the ablation electrode may be obtained when the ablation electrode is connected to a radiofrequency ablation host.

[0251] In some embodiments, the radiofrequency ablation system may determine the availability of the ablation electrode based on the electrode information.

[0252] In some embodiments, Fig. 20 As shown, 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 Figure 3 and its related description.

[0253] Step 1830: In response to the ablation electrode being available and the state of the radiofrequency ablation system satisfying a preset condition, ablation is performed on the eye tissue based on the ablation parameters. Figure 1 and its related description.

[0254] In some embodiments, Fig. 22 As shown, in response to the ablation electrode being available, the interactive interface 2000 can 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 will be highlighted, and when the ablation electrode is not connected, the electrode icon will be dimmed. If the user confirms that the electrode information is correct, he can confirm it by clicking the confirmation button in the figure; if the user believes that the electrode information is incorrect, he can replace the connected ablation electrode, or request after-sales maintenance personnel to handle it. After-sales maintenance personnel can correct and rewrite the error information stored in the electrode.

[0255] In some embodiments, in response to the ablation electrode being available and the electrode information being confirmed, a parameter setting interface (eg, Fig.23 In some embodiments, Fig.23 As shown, 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 times remaining, 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 times remaining, the cumulative ablation time, and the remaining ablation time, please refer to Figure 1 and its related description.

[0256] In some embodiments, in response to the ablation electrode not being connected, the electrode icon may be grayed out, in response to the foot switch not being connected, the foot switch icon may be grayed out, and even in the case where the accessories (ablation electrode and foot switch) are not connected, the system will enter the Fig.23Schematic treatment parameter setting page, based on which the demonstration and teaching of the radiofrequency ablation system can be facilitated when no accessories are connected.

[0257] 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.

[0258] 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 of the recommended parameter values, or target parameters input by the user based on the recommended parameter range. In response to receiving confirmation information from the user, the control module may determine the parameter value corresponding to the confirmation information as the target parameter.

[0259] Exemplarily, in response to the ablation electrode being available and confirmed by the user, the control module can recommend a 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 a 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.

[0260] In some embodiments, when the ablation electrode is available, before or after the electrode information is confirmed, it can be detected 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 enter the next step by clicking the "Confirm" button in the interface or connecting the foot switch. Fig. 22 The confirmation page of electrode identification shown in FIG24 or the parameter setting page shown in FIG23 is displayed. It is worth noting that the connection order of the foot switch and the ablation electrode is not limited. In some embodiments, the foot switch can be detected first and then the ablation electrode can be detected, or the foot switch and the ablation electrode can be detected at the same time, or the ablation electrode can be detected first and then the foot switch can be detected. 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, Fig.21 As shown, in response to the second preset condition not being met to activate the foot switch, the interactive interface 2000 may display a warning message “Please release the foot switch”.

[0261] 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 descriptions of the first preset condition and the second preset condition, see Figure 1 and its related description.

[0262] In some embodiments, Fig.19 As shown, if the ablation electrode is available and the status of the RF ablation system meets the 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.

[0263] In some embodiments, Fig.24 As shown, in response to the start of treatment, the interactive interface 2000 may display an information display page in the treatment start, such as electrode status, treatment time, radio frequency power, treatment time, real-time impedance, electrode life information, etc. For information about treatment time and real-time impedance, please refer to Figure 1 and its related description.

[0264] The electrode status may include electrode information, which may be used to indicate whether the ablation electrode is outputting radio frequency energy. The electrode life information may include the number of times used, the number of times remaining to be used, or the accumulated ablation time, and the remaining ablation time.

[0265] In some embodiments, Fig.19 As shown, during the ablation of eye tissue, in response to impedance mutation, release of the foot switch, or 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 eye tissue will mutate, and the impedance mutation can indicate the completion of the RF treatment. Specifically, the threshold of the mutation can be determined according to different target tissues, such as setting the threshold to impedance greater than a certain value. Alternatively, the impedance mutation can also be judged by the change of the impedance change amount (difference) collected multiple times, for example, the impedance change amount tends to zero to form an inflection point, or the impedance change increment exceeds the preset value.

[0266] In some embodiments, Fig.19 As shown, in response to the ocular tissue not needing to be treated again, 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 the RF energy output.

[0267] 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 times it remains to be used, or the cumulative ablation time, the remaining ablation time) back into the storage chip of the ablation electrode.

[0268] The ophthalmic radiofrequency ablation system of this manual can achieve multiple uses: based on the thermal effect of radiofrequency ablation, when the 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, the contraction of the ciliary body will also increase the gap between the choroid and sclera (suprachoroidal space), producing the effect of suprachoroidal space drainage. On the other hand, the radiofrequency ablation device can be used to replace the appropriate electrode needle shape to perform radiofrequency ablation of the trabecular meshwork, and ablation holes can be made in the circumferential direction of the trabecular meshwork, so that the aqueous humor in the anterior chamber can flow through the ablation holes on the trabecular meshwork into the Schlemm canal to treat early and middle-stage open-angle glaucoma. In addition, for radiofrequency ablation of the iris, by replacing the appropriate electrode needle shape through this radiofrequency ablation device, radiofrequency ablation can also be performed on the iris to make a hole, so that the anterior chamber and the posterior chamber are connected, and the effect of iridotomy can be achieved. On the one hand, by replacing the appropriate electrode needle, it can also be used to ablate the sclera, and an ablation tunnel is formed from the anterior chamber angle to the sclera through ablation to achieve subconjunctival drainage. In addition, the radiofrequency ablation system of this manual can also be used to stop bleeding on the ocular surface or inside the eye.

[0269] 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.

[0270] In some embodiments, numbers describing the number of components and attributes are used. It should be understood that such numbers used in the description of the embodiments are modified by the modifiers "about", "approximately" or "substantially" in some examples. Unless otherwise specified, "about", "approximately" or "substantially" indicate that the numbers are allowed to vary by ±20%. Accordingly, in some embodiments, the numerical parameters used in the specification and claims are approximate values, which may change according to the required features of individual embodiments. In some embodiments, the numerical parameters should take into account the specified significant digits and adopt the general method of retaining digits. Although the numerical domains and parameters used to confirm the breadth of their range in some embodiments of this specification are approximate values, in specific embodiments, the setting of such numerical values ​​is as accurate as possible within the feasible range.

[0271] If there is any inconsistency or conflict between the descriptions, definitions, and / or usage of terms in the materials cited in this specification and the contents described in this specification, the descriptions, definitions, and / or usage of terms in this specification shall prevail.

Claims

1. An ophthalmic radiofrequency ablation system, characterized in that: include: An ablation electrode, the ablation electrode comprising: An electrode needle with a pointed tip and an operating handle, wherein the electrode needle is mounted on the operating handle, and the electrode needle is cylindrical in shape as a whole, and its cross section includes an electrode inner pole, a first insulating layer, an electrode outer pole, and a second insulating layer in a radial direction from the inside to the outside in sequence, and the tip of the electrode needle is formed into a cone shape by grinding, and during the grinding process, the tip of the conical needle tip is formed by the electrode inner pole to form a needle tip, and the electrode outer pole on the cone surface is exposed as the grinding proceeds, and the electrode inner pole, the first insulating layer, the electrode outer pole, and the second insulating layer form an inner pole region, a first insulating region, an outer pole region, and a second insulating region in sequence on the cone surface of the tip in a circumferential direction from the cone tip to the cone bottom; the tip is used to penetrate into eye tissue to ablate the eye tissue based on radio frequency energy; An adjusting tube, wherein the adjusting tube is fixedly mounted on the operating handle, the adjusting tube is inserted into the outer surface of the electrode needle, and can move relative to the axial direction of the electrode needle, and is used to adjust the length of the electrode needle exposed from the adjusting tube, and the length of the electrode needle exposed from the adjusting tube is the depth of the electrode needle piercing the eye tissue; the inner diameter of the adjusting tube is greater than the outer diameter of the electrode needle, and a protruding step is formed between the electrode needle and the adjusting tube, and when the tip of the electrode needle pierces the eye tissue, the protruding step abuts against the eye surface, preventing the adjusting tube from piercing the eye tissue; The radiofrequency ablation host comprises a power module, a control module, a radiofrequency 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 to the ablation electrode when the ablation electrode is electrically connected to the radio frequency ablation host; The impedance detection module is configured to detect 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, when the ablation electrode is electrically connected to the radiofrequency ablation host, obtain electrode information of the ablation electrode, transmit the electrode information to the control module, and / or write usage information of the ablation electrode recorded by the radiofrequency ablation host 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, characterized in that 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 RF signal source and is used to generate RF energy based on the RF signal output by the RF 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 RF power supply comprises a voltage-adjustable power supply, and the voltage-adjustable power supply is configured to adjust the voltage to a target value based on the instruction sent by the control module so that the RF module generates a RF signal with a predetermined output power; The radio frequency signal includes at least one of a weak current waveform, a square wave, a sine wave and a triangle wave, and the frequency of the radio frequency signal is in the range of 300KHz-3MHz; The power amplifier module adopts a class D power amplifier circuit; or adopts a power switch and a transformer, and the power switch and the transformer are connected through a flyback topology, a push-pull topology or a full-bridge topology circuit; or adopts a circuit structure of a power amplifier 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 and 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 RF energy output stops. The control module is further used to determine whether the tip of the ablation electrode reaches the target position based on the impedance information, and control the RF module to output RF energy in response to reaching the target position; The voltage and 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, and the single-pole double-throw switch is used to switch the ablation electrode connected to the radio frequency ablation host between being connected to the radio frequency module or the impedance detection module; wherein, Before the radio frequency energy is output or after the output stops, the single-pole double-throw switch is connected to the impedance monitoring unit, so that the impedance monitoring unit monitors the impedance information of the eye tissue; When the output of the radio frequency energy is turned on, the single-pole double-throw switch is connected to the radio frequency module, so that the radio frequency module provides the radio frequency energy to the ablation electrode.

5. The system according to claim 1, characterized in that The input / output module comprises: A human-machine interaction unit, used to control the start and stop of radiofrequency energy output, and / or set ablation parameters; and An output unit, used to display treatment information, electrode information and / or prompt information to the user; Wherein, the human-machine interaction unit includes at least one of a foot switch, an activation switch and an input button; the ablation parameter includes at least one of an output power of a radio frequency signal, a treatment time and a treatment mode; Or, the output unit includes a display screen, the treatment information includes at least one of the treatment time, the output power of the radio frequency signal, and the real-time impedance, the electrode information includes at least one of the electrode type of the ablation electrode, the electrode validity period information, and the electrode life information, and the prompt information includes the accessory connection status and / or warning information; the electrode validity period information includes the production date, the production shelf life, the first use time and the preset usage time range after the first use, and the electrode life information includes the number of uses and the remaining number of uses, or the cumulative ablation time and the remaining ablation time.

6. The system according to claim 5, characterized in that The treatment mode includes a continuous treatment mode and / or a single treatment mode, wherein in the continuous treatment mode, the tip of the electrode needle may release radiofrequency energy multiple times after entering the eye tissue; The ophthalmic radiofrequency ablation system is configured to have a continuous output mode and / or a timed output mode, wherein the continuous output mode or the timed output mode reflects the output manner of the radiofrequency energy.

7. The system according to claim 6, characterized in that In the continuous output mode, starting the foot switch starts the output of the radio frequency energy, and closing the foot switch or the activation switch stops the output of the radio frequency energy; In the timing output mode, the foot switch is activated to start the output of the RF energy and start timing. When the timing reaches a preset time threshold, the output of the RF energy is automatically stopped. When the timing does not reach the preset time threshold but the foot switch is turned off or the activation switch is turned off, the output of the RF energy is stopped.

8. The system according to claim 7, characterized in that In the continuous output mode or the timed output mode, each time the output of the RF energy is stopped, the RF ablation host records the usage information of the ablation electrode and updates the electrode life information of the ablation electrode currently in use; the output of the RF energy also includes impedance judgment before output, and when the impedance is zero or not within the preset impedance threshold range, the RF energy is not output.

9. The system according to claim 5, characterized in that The accessory connection status includes whether the foot switch or 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 not authorized or verification failed, electrode life ended, electrode expired, foot switch not connected, self-test failed, please release activation switch, please release foot switch.

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

11. The system according to claim 1, characterized in that The radiofrequency ablation host also includes at least one of the following: Power filter, used to suppress noise in AC power; A memory, used for storing ablation parameters; A real-time clock is used to provide time information to the radiofrequency ablation host.

12. The system according to claim 1, characterized in that The ablation electrode further comprises a storage chip, and the storage chip is used to store at least one of the model, encryption information, electrode type, electrode validity period information, electrode life information and data verification code of the ablation electrode.

13. The system according to claim 12, characterized in that The electrode validity period information includes the first use time, and the electrode life information includes the number of uses and the number of remaining uses. The first use time is actively written into the storage chip by the radiofrequency ablation host when the ablation electrode is connected to the radiofrequency ablation host for the first time; The remaining number of uses and the number of uses are actively updated and written into the storage chip by the RF ablation host each time the RF ablation host is connected, or the remaining number of uses and the number of uses of the electrode are updated after each RF 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 as follows: Based on the acquired electrode information, determining the availability of the ablation electrode; In response to the ablation electrode being unavailable, prompting through the input / output module; or In response to the ablation electrode being available, the electrode information is displayed through the input / output module and a user confirmation is requested.

15. The system according to claim 14, characterized in that The ablation electrode can be used including that the ablation electrode is a verified authorized electrode, has not exceeded the effective usage period, and has a remaining usable life of 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: include: Radiofrequency ablation host, used for providing radiofrequency energy; Accessories connected to the radiofrequency ablation host, the accessories including a foot switch and an ablation electrode; The foot switch is used to control the output and stop of the radio frequency energy, and the ablation electrode is used to perform ablation based on the radio frequency energy; Wherein, the ablation electrode comprises: An electrode needle with a pointed tip, the electrode needle is cylindrical in shape as a whole, and its cross section includes an electrode inner pole, a first insulating layer, an electrode outer pole, and a second insulating layer in the radial direction from the inside to the outside. The tip of the electrode needle is formed into a cone by grinding. During the grinding process, the tip of the conical needle tip is formed by the electrode inner pole. The electrode outer pole on the cone surface is exposed as the grinding progresses. The electrode inner pole, the first insulating layer, the electrode outer pole, and the second insulating layer form an inner pole region, a first insulating region, an outer pole region, and a second insulating region on the cone surface of the tip in the circumferential direction from the cone tip to the cone bottom. 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 adjusting component, which is inserted into the outer surface of the electrode needle and can move relative to the axial direction of the electrode needle, and is used to adjust the length of the electrode needle exposed from the adjusting component. The length of the electrode needle exposed from the adjusting component is the depth of the electrode needle piercing the eye tissue; The adjustment component includes an adjustment tube, the inner diameter of which is larger than the outer diameter of the electrode needle, and a protruding step is formed between the electrode needle and the adjustment tube. When the tip of the electrode needle penetrates into the eye tissue, the protruding step abuts against the eye surface, preventing the adjustment tube from penetrating into the eye tissue.

17. The system according to claim 16, characterized in that The ablation electrode further comprises: an operating handle, on which the electrode needle is mounted; Among them, the operating handle is provided with a first through hole, which is a step hole with a step surface, and the first through hole allows the rear end of the electrode needle to pass through and be fixed in the first through hole; the adjustment component is inserted into the first through hole and fixedly abutted against the step surface.

18. The system according to claim 17, characterized in that The ablation electrode further comprises: An electrode needle protection cap, which is a hollow conical structure and is used to cover the electrode needle and is fixed to the periphery of the end of the operating 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 to allow the adjustment tube to pass through the second through hole; Wherein, the adjustment component includes the adjustment tubes of various lengths, and the adjustment tubes of different lengths of the ablation electrode can be replaced through the electrode needle protection cap.

19. The system according to claim 16, characterized in that The radiofrequency ablation host includes a control module and an information reading module, wherein: The information reading module is used to obtain the electrode information of the ablation electrode and transmit it to the control module after the ablation electrode is electrically connected to the radio frequency ablation host; The control module is used to verify the availability of the ablation electrode based on the electrode information, and make parameter recommendations when the ablation electrode is available; The control module is also used to detect the connection status of the accessory and whether the foot switch is abnormally activated, and to provide a prompt when the accessory is not connected or the foot switch is abnormally activated; the abnormal activation of the foot switch includes the activation of the foot switch in a non-treatment interface.

20. The system according to claim 19, characterized in that The radiofrequency ablation host also includes an impedance detection module and a radiofrequency module; The impedance detection module is used to detect impedance information during the ablation process and transmit the impedance information to the control module; The control module is further used to determine whether the tip of the ablation electrode reaches the target position based on the impedance information, and control the radio frequency module to output radio frequency energy in response to reaching the target position; The control module is also used to control the RF energy to stop outputting when the impedance information suddenly changes; or automatically stop outputting the RF energy in response to the foot switch being released or the timing reaching the output duration of the RF energy.

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