Radiofrequency generating treatment device for cardiac radiofrequency ablation treatment

Abstract

The present invention discloses a radio frequency generating treatment device for cardiac radio frequency ablation treatment, the device comprises a shell, and a power module, a radio frequency generating unit and an electrophysiological recording unit are arranged in the shell; the power module is used to provide electric energy for the radio frequency generating unit and the electrophysiological recording unit; the radio frequency generating unit comprises a power control module, a low voltage adjustable DC power supply, a power inverter, a high frequency power transformer, a back electrode and a radio frequency ablation catheter; the power control module is connected to other components of the radio frequency generating unit; the low voltage adjustable DC power supply is used to output a constant voltage with variable voltage; the power inverter is used to convert the input DC voltage into a corresponding high frequency AC power signal; the high frequency power transformer couples the signal to the radio frequency ablation catheter and the back electrode. The present invention can reduce the size and volume of the cardiac electrophysiological diagnosis and treatment system, and simplify the interconnection between the various components, making it more stable and having a lower failure rate.

Description

Technical Field

[0001] The present invention relates to the field of cardiac electrophysiological treatment, and more particularly to a radio frequency generating treatment device for cardiac radio frequency ablation treatment. Background Art

[0002] The mainstream method of cardiac interventional treatment is to use an interventional catheter to obtain local excitation signals from the surface of the heart. The operator analyzes the signals through instruments and equipment, determines the cause of the disease, and then delivers radio frequency energy to the heart tissue through the interventional catheter.

[0003] Currently, the equipment commonly used in cardiac interventional surgery is the multi-channel electrophysiological recorder system and the cardiac radiofrequency ablation device. The former is used to detect and diagnose heart disease lesions through the interventional catheter, and the latter, as an independent radiofrequency ablation device, uses the interventional catheter to release high-frequency electrical energy to the target area, causing the target tissue to heat up, the protein to denature and lose its activity, thereby achieving the treatment goal.

[0004] Among the currently disclosed products and technical solutions, the two devices are two independent products. The two systems are connected through external interconnection wires and coordinated by the operator. This method brings many disadvantages: the devices are interconnected through a series of external cables, the wiring is complicated, and the connection is easily interfered and damaged, affecting the progress of the operation.

[0005] At the same time, the principle of traditional radio frequency energy generation technology generally adopts A / B class amplifiers, which are inefficient and generate severe heat. Radio frequency ablation equipment is often large in size and heavy in weight, causing it to occupy limited operating room space. In addition, independent ablation equipment and related connecting cables require regular maintenance, and the transportation and storage costs are high.

[0006] In addition, the two devices are often manufactured by different manufacturers, and the two systems are generally incompatible and information cannot be integrated. As a result, the surgeon's perspective needs to switch between the electrophysiological recorder and the radiofrequency ablation system, which can easily cause surgeon fatigue.

[0007] Therefore, there is currently a lack of a radio frequency system in the art that can reduce the overall size and volume of the cardiac electrophysiological diagnosis and treatment system, simplify the interconnection between various devices in cardiac interventional surgery, and work more stably with a lower failure rate. Summary of the invention

[0008] The purpose of the present invention is to provide a radio frequency generating treatment device for cardiac radio frequency ablation treatment, which can reduce the overall size and volume of the cardiac electrophysiological diagnosis and treatment system, and simplify the interconnection between various devices of cardiac interventional surgery, so that the operation is more stable and has a lower failure rate.

[0009] The present invention provides a radio frequency generating treatment device for cardiac radio frequency ablation treatment. Specifically, the device includes a shell, and a power module, a radio frequency generating unit and an electrophysiological recording unit are arranged in the shell; the power module is used to provide electric energy for the radio frequency generating unit and the electrophysiological recording unit; the radio frequency generating unit includes a power control module, a low-voltage adjustable DC power supply, a power inverter, a high-frequency power transformer, a back electrode and a radio frequency ablation catheter; the power control module is connected to other components of the radio frequency generating unit, and the power control module is used to collect voltage, current and power parameters fed back by the power inverter and the sensor circuit, and automatically adjust the working state of the power inverter and the low-voltage adjustable DC power supply to perform closed-loop control; the low-voltage adjustable DC power supply is used to output a constant voltage with variable voltage; the power inverter is electrically connected to the low-voltage adjustable DC power supply, and the power inverter is used to convert the input DC voltage into a corresponding high-frequency AC power signal; the high-frequency power transformer couples the high-frequency AC power signal to the radio frequency ablation catheter and the back electrode, and the radio frequency ablation catheter and the back electrode perform ablation treatment on the lesion.

[0010] In another preferred embodiment, a communication backplane is further provided in the housing, the communication backplane is electrically connected to the power module, the communication backplane is used to provide DC power to the device, and the communication backplane is a medium for exchanging information between the device and the computer.

[0011] In another preferred embodiment, data exchange between the communication backplane and the computer is based on a wired network, optical fiber or wireless network.

[0012] In another preferred embodiment, the radio frequency generating unit and the electrophysiological recording unit are any of the following structures: a card structure, a stacked structure or a structure consisting of multiple electronic circuits.

[0013] In another preferred embodiment, the power supply module is in the form of a high-frequency switching power supply, or in the form of an industrial frequency rectifier.

[0014] In another preferred embodiment, the output voltage of the low voltage adjustable DC power supply is 0-20V.

[0015] In another preferred embodiment, a switch is provided between the communication backplane and the low-voltage adjustable DC power supply unit for interrupting the output of radio frequency energy and cutting off the power supply of the power part when the current and voltage are overloaded.

[0016] In another preferred embodiment, the output power of the power inverter is 0-100W.

[0017] In another preferred embodiment, the device comprises an external foot switch, which is used to control the operation or termination of radio frequency excitation.

[0018] In another preferred embodiment, the power module is located inside the housing, or is placed outside the housing.

[0019] The main advantages of the present invention include:

[0020] (a) The overall size and volume of the electrophysiological diagnosis and treatment system are reduced.

[0021] (b) Simplify the interconnection between various components of cardiac interventional surgery.

[0022] (c) More stable and with lower failure rate.

[0023] (d) Maintenance work on independent ablation equipment and related connecting cables is avoided.

[0024] (e) Reduce storage and transportation costs.

[0025] (f) It avoids the incompatibility problem between the multi-channel electrophysiological recorder system and the cardiac radiofrequency ablation device.

[0026] (g) Improve work efficiency.

[0027] Therefore, the present invention utilizes the miniaturization of the radiofrequency ablation power unit and combines it with the electrophysiological device to form an integrated device, which greatly reduces the space occupied and effectively reduces the space occupied by the operating bed. At the same time, it also greatly reduces the equipment transportation cost and has obvious clinical value; the integrated system is interconnected through internal wiring, which reduces the reliability problems caused by human factors and device factors during use and reduces the risks in clinical practice; the modular design makes the maintenance and replacement of the radiofrequency unit very convenient and rapid.

[0028] It should be understood that within the scope of the present invention, the above-mentioned technical features of the present invention and the technical features specifically described below (such as embodiments) can be combined with each other to form a new or preferred technical solution. Due to space limitations, they will not be described one by one here. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0030] Figure 1 It is a schematic diagram of the structure of a radio frequency generating treatment device in an example of the present invention.

[0031] Figure 2 It is an overall perspective view of a radio frequency generating treatment device in one example of the present invention.

[0032] Figure 3It is a working flow chart of the radio frequency generating unit in one example of the present invention.

[0033] Figure 4 It is a module schematic diagram of a radio frequency generating unit in an example of the present invention.

[0034] Figure 5 It is a diagram of output power of a radio frequency generating unit on different loads under different control voltages in an example of the present invention.

[0035] Figure 6 It is a waveform diagram of interference of the radio frequency generating unit on the electrophysiological waveform before and after the radio frequency is working and not working in one example of the present invention.

[0036] In the accompanying drawings, the symbols are as follows:

[0037] 1- Power cord;

[0038] 2- Communication cable;

[0039] 3- Computer host;

[0040] 4- Display;

[0041] 5- Power module;

[0042] 6-Communication backplane;

[0043] 7- housing;

[0044] 8-Low voltage adjustable DC power supply;

[0045] 9-Electrophysiological function board;

[0046] 10-RF power generating unit;

[0047] 11- Power inverter;

[0048] 12-connector;

[0049] 13- Foot switch connection interface;

[0050] 14- Radiofrequency ablation catheter interface;

[0051] 15-RF loop electrode interface;

[0052] 16-External foot switch;

[0053] 17- Radiofrequency ablation catheter;

[0054] 18-RF loop back electrode;

[0055] 19-Sensor Networks;

[0056] 20-power control module;

[0057] 21- high frequency power transformer;

[0058] 22-Isolation interface divider. DETAILED DESCRIPTION

[0059] After extensive and in-depth research and a large amount of screening, the inventor has developed for the first time a radio frequency generating treatment device for cardiac radio frequency ablation treatment. The device is a highly integrated radio frequency generator device with a novel structure. The device is designed as a standard modular structure and is designed to be small enough so that it can be integrated into other cardiac interventional diagnostic equipment (such as electrophysiological recording devices, or similar cardiac electrophysiological three-dimensional mapping devices). The device uses support systems such as power supplies, communication interfaces, and software interface systems that are already available in other diagnostic equipment to achieve the power supply, communication, and human-machine interface functions that the complete instrument needs to provide, thereby reducing the redundancy of these components, reducing the overall volume after integration, simplifying connections, improving surgical efficiency, reducing failure rates, and making the system easier to use and maintain. The present invention was completed on this basis.

[0060] Typically, the radio frequency generating treatment device for cardiac radio frequency ablation therapy of the present invention utilizes the miniaturization of the radio frequency ablation power unit and combines it with the electrophysiological device to form an integral device. The miniaturized power unit can be covered in an integral housing together with the power supply and other amplifier units of the electrophysiological device. The interconnection between the unit and other parts of the electrophysiological device is carried out through an internal cable, which is hidden in the overall housing. The original electrophysiological system computer equipment is used as a display device and a recording device for the corresponding functions of the radio frequency generator.

[0061] It should be noted that the modularization of the RF unit of the board-based Class E amplifier is only one form of implementation of the present invention. Professional and technical personnel in the industry can choose different high-power density technologies. Regardless of the form, they are still within the scope of the present invention. Similarly, it is not based on modularization, but an overall design, which may achieve a smaller overall volume, and is also within the scope of the present invention. The electrophysiological diagnostic equipment described in the present invention generally refers to a special cardiac intervention equipment that provides diagnostic functions. This equipment can provide waveform tracing / recording / playback, catheter navigation mapping, electrophysiological stimulation, and one or more of many other functions. The communication backplane described in the present invention can also be a bunch of wires, which mainly embodies the functions of power supply and communication, and does not necessarily have to be a backplane.

[0062] The present invention will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and are not intended to limit the scope of the present invention. In addition, the accompanying drawings are schematic diagrams, so the device and apparatus of the present invention are not limited by the size or ratio of the schematic diagrams.

[0063] It should be noted that in the claims and description of this patent, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the sentence "including one" do not exclude the existence of other identical elements in the process, method, article or device including the elements.

[0064] Example

[0065] The core of the present invention is a modular, independently working RF power generating device, which needs to be integrated into other diagnostic devices necessary for cardiac interventional surgery, and utilizes the existing power supply, communication, human-machine interface and other components in these diagnostic devices to complete the functions required by a complete cardiac electrophysiological ablation device. It should be clear that this integration, although relying on the functions provided by the host device, these functions are originally necessary in these host devices or systems.

[0066] The radio frequency generating treatment device of this embodiment includes a radio frequency generating unit, an electrophysiological recording unit, a communication backplane 6 and a power module 5 (AC / DC unit). The above components are placed in a compact housing 7 with a heat dissipation design to form a whole, serving as a new two-in-one radio frequency power treatment and electrophysiological diagnosis device.

[0067] like Figure 1 and Figure 2 As shown, an independently working radio frequency generating unit is added to the original electrophysiological recording system. The radio frequency generating unit is designed as a board-type structure. The unit can also be designed in other forms, such as a stacked type, or even composed of multiple electronic circuits. However, its main feature is that it is integrated with the electrophysiological recording unit in a housing 7, and can be connected to the electrophysiological recording unit without going through an external cable. During normal use, the device does not need to be physically touched by the operator.

[0068] The electrophysiological recording unit is used to obtain one or more of the patient's cardiac excitation information, catheter position information, patient blood pressure information and other electrophysiological information. The unit can also be designed to emit electrical stimulation to the heart. The medium for achieving the above functions is through another interventional catheter or multiple electrodes connected to the heart or human body.

[0069] The RF generating unit can be installed on a communication backplane 6 connected to the computer host 3 via a communication cable 22, obtain power supply therefrom, and exchange various data (such as the power required to be set for the RF, the actual power generated, the measured tissue impedance, the RF temperature, etc.) with the computer host 3 via the communication backplane 6, and finally present the data that needs to be presented to the operator on the display 4. As an implementation method, this data exchange can be based on wired network communication of the communication cable 22, but it can also be in other forms, such as optical fiber or even wireless. The external foot switch 16 is connected to the communication backplane 6 via the foot switch connection interface 13, and the operation or termination of the RF excitation can be effectively controlled by the external foot switch 16.

[0070] The communication backplane 6 is powered by a wall power system through an independent power module 5 via a power cord 1. One implementation form of the power module 5 may be a high-frequency switching power supply, but it may also be an industrial frequency rectifier. The former is an optimized implementation because of its higher power density. The power module 5 may be built into the housing 7 or placed outside the housing 7, thereby further reducing the size of the device. In this regard, there are already very mature commercial power modules available.

[0071] The radio frequency generating unit 10 obtains a stable, high-power DC power supply from the communication backplane 6. After the power supply enters the radio frequency generating unit 10, it undergoes voltage conversion through the low-voltage adjustable DC power supply 8 to generate a variable voltage constant voltage output. Since other electrophysiological function boards 9 process very weak human body signals, the output of the adjustable power supply must be carefully processed to reduce the impact of space radiation emissions on the electrophysiological boards. This embodiment reduces the range of the output voltage to ensure the impact on the voltage output. In principle, a lower adjustable voltage needs to be selected, but under the condition of constant output power, a lower adjustable voltage means a larger output current, which often increases the loss of the device, especially the transformer and the switch tube. In order to withstand a larger current, the size of the device needs to be increased. Experience has shown that an adjustable output voltage of less than 20V can achieve an acceptable balance between low voltage and high current while ensuring that the circuit volume is still relatively small. This balance between reducing space radiation emissions and device volume can be achieved by using power transistors with smaller on-resistance and higher switching frequency. For example, Figure 6 As shown, the left side of the isolation interface dividing line 22 is during RF power output, and the right side is when the power output is stopped. It can be seen that no interference changes are shown on the RF output electrode and other electrodes before and after the power output is stopped.

[0072] The variable voltage generated by the low-voltage adjustable DC power supply 8 is loaded onto the power inverter 11 behind it. The power inverter 11 is responsible for converting the input DC voltage into a corresponding high-frequency AC power signal, which is loaded onto the human body through the high-frequency power transformer 21. The voltage, current and temperature signals actually received by the human body are transmitted back to the power control module 20 of the power unit through the isolated sensor network 19. The power control module 20 sets the power according to the setting requirements transmitted by the computer host 3 through the communication backplane 6, and monitors various parameters on the human body. As the hub of the RF power unit, it completes various functional controls.

[0073] The device is connected to various interfaces on the panel of the electrophysiological system through an internal cable or connector 12, and these interfaces can be increased or reduced according to actual needs. In this embodiment, a radiofrequency ablation catheter interface 14 and a radiofrequency loop electrode interface 15 are provided. These interfaces are used to connect the radiofrequency ablation catheter 17 and the radiofrequency loop back electrode 18 during the operation. A typical example of use is that the radiofrequency ablation catheter 17 is connected to the human body as one pole of the loop electrode, and the back electrode forms a closed loop with the human body as the other pole of the loop. The high-frequency current emitted by the high-frequency power transformer 21 is loaded into the human tissue through the two, especially the tissue near the head of the radiofrequency ablation catheter 17, forming a high-frequency thermal effect to complete the ablation. Another implementation of the radiofrequency loop back electrode is to simplify it to another electrode on the radiofrequency ablation catheter 17. This form of ablation is clinically called bipolar ablation. This change does not affect the essence of the present invention.

[0074] The method for realizing the function of the RF generating unit 10 is to use the class E power amplifier technology with higher power density, so as to realize the inversion of RF power with a smaller volume. As a specific implementation, a design of the RF power generating unit 10 is described as follows:

[0075] like Figure 3 As shown, the backplane connector provides all the connections required by the board: digital communication interface, 24V power input, RF energy output, back electrode output, and catheter temperature sensor input.

[0076] The digital communication interface is responsible for transmitting control data between the backplane and the FPGA control logic. Considering the anti-interference performance of signal transmission, low voltage differential signal (LVDS) is used for output transmission. Various control parameters of the RF module are imported from this interface, and the working data such as power and impedance processed by the control logic in the field programmable logic array (FPGA) are also transmitted to the backplane through this interface.

[0077] The 24V input is used as the overall power supply of the module. After entering the board, it is divided into two paths. One path passes through the DCDC conversion circuit to generate a low-voltage power supply to the internal circuit, and the other path passes through the 24V electronic switch to the power conversion part. The role of the 24V electronic switch is to serve as a redundant design to reliably interrupt the output of RF energy under any circumstances. Another function of the 24V electronic switch is to cut off the power supply when the current and voltage are overloaded, protecting the power supply and subsequent circuits from further damage.

[0078] The 24V through the electronic switch is connected to a 200W Bulk voltage conversion circuit, the purpose is to generate a 0-20V adjustable voltage, the control signal of the adjustable voltage output value is generated by the FPGA control analog DAC. The FPGA module generates a 400-500KHz adjustable PWM signal, which is sent to the ClassE power amplifier for power amplification. The power of the same frequency amplified by the ClassE amplifier is transmitted to the human body after coupling through the power transformer. The actual output power here is controlled by the human body load and the ClassE power supply, that is, the 0-20V Bulk voltage output. After the FPGA module collects the actual power value of the human body, it can compensate by adjusting the output voltage of the Bulk power supply to ensure the stability of the power output. This adjustment is completed by the PID adjustment module in the FPGA. The PID module ensures the stability of the output power according to the set target power. The set target power is determined by the control signal on the backplane, so that the output power can be stable and adjustable according to the set power. It will not be described in detail here. It is worth mentioning that considering that the Class E circuit works in a switching state, it is crucial to ensure that each transistor therein works in the ZVS and ZCS switching states. This is mainly reflected in the need for precise adjustment between the Class E filter circuit and the actual operating frequency of the circuit. Under certain component tolerances, the ZVS and ZCS states of the power transistors can be guaranteed by adjusting the actual FPGA PWM output operating frequency. The actual load of the Class E power amplifier is human tissue, and its output effective 0-100W adjustable power can ensure the effect of radiofrequency ablation. The effective impedance range of human tissue is 50Ω-300Ω. Within this impedance range, under the given input voltage range (0-20V). Figure 5 As shown in the figure, under different load impedances, the output power increases as the bulk voltage increases.

[0079] The power signal loaded into the human body is picked up by the voltage and current transformers connected across the isolation interface, and then picked up by the broadband signal conditioning circuit and then passed through the high-speed analog-to-digital conversion circuit to enter the FPGA control logic. The FPGA is directly obtained by the digital circuit in the form of P=VxI. In order to prevent a single failure in any link of the above link from causing abnormal power actually loaded on the patient side, another set of backup voltage and current sensor circuits is designed. The power is calculated through the analog power measurement circuit, and the generated power signal is converted into a digital signal through the low-speed analog-to-digital conversion circuit and transmitted to the FPGA. The two power signals are compared in the FPGA. In the case of abnormal values ​​of the two sensors, the FPGA can shut off the power supply of the power part through the 24V switch.

[0080] In addition, the temperature signal on the catheter involved in the radiofrequency ablation application is picked up by the sensor on the catheter head and sent to the thermocouple or thermistor temperature sensor conditioning circuit on the board for processing. After being converted into a digital signal, it is sent to the FPGA through digital isolation. The temperature signal fed back from the FPGA can participate in closed-loop control when necessary to achieve constant temperature discharge.

[0081] like Figure 4 As shown, the above sub-modules are designed on a circuit board with a size of 250mm*170mm*30mm.

[0082] All documents mentioned in the present invention are cited as references in this application, just as each document is cited as reference individually. In addition, it should be understood that after reading the above teachings of the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms also fall within the scope defined by the claims attached to this application.

Claims

1. A radio frequency generating treatment device for cardiac radio frequency ablation treatment, characterized in that: The device comprises a housing, and a communication backplane, a power module, a radio frequency generating unit and an electrophysiological recording unit are arranged in the housing; The radio frequency generating unit and the electrophysiological recording unit are interconnected via an internal cable, which is hidden in the overall housing; The power module is used to provide power to the radio frequency generating unit and the electrophysiological recording unit; The radio frequency generation unit includes a power control module, a low voltage adjustable DC power supply, a power inverter, a high frequency power transformer, a back electrode, a radio frequency ablation catheter and a sensor network; The power control module is connected to all other components of the radio frequency generating unit, and is used to collect the voltage, current, and power parameters fed back by the power inverter and the sensor circuit, and automatically adjust the working state of the power inverter and the low-voltage adjustable DC power supply to perform closed-loop control; The low-voltage adjustable DC power supply is used to output a constant voltage with a variable voltage; The power inverter is electrically connected to a low-voltage adjustable DC power supply, and the power inverter is used to convert an input DC voltage into a corresponding high-frequency AC power signal; The high-frequency power transformer couples the high-frequency AC power signal to the radiofrequency ablation catheter and the back electrode, and the radiofrequency ablation catheter and the back electrode perform ablation treatment on the lesion site; The voltage, current and temperature signals actually received by the human body are transmitted back to the power control module of the power unit through the isolated sensor network. The power control module sets the power according to the setting requirements transmitted by the computer host through the communication backplane, and monitors various parameters. As the hub of the RF power unit, it completes various functional controls; The electrophysiological recording unit is used to obtain one or more of the electrophysiological information of the patient's cardiac excitation information, the position information of the catheter, and the patient's blood pressure information; The radio frequency generating unit and the electrophysiological recording unit are both board-card structures, and the board-card radio frequency generating unit and the electrophysiological recording unit are mounted on the communication backplane; The communication backplane is electrically connected to the power module, the communication backplane is used to provide a DC power supply for the device, and the communication backplane is a medium for exchanging information between the device and the computer; The RF generating unit obtains a stable high-power DC power supply from the communication backplane. After the power supply enters the RF generating unit, it undergoes voltage conversion through the low-voltage adjustable DC power supply, and generates a 0-20V variable constant voltage output through the Bulk voltage conversion circuit; the FPGA module generates a 400-500KHz adjustable PWM signal, which is sent to the ClassE power amplifier for power amplification. The power of the same frequency amplified by the ClassE amplifier is transmitted to the human body after coupling through the subsequent power transformer; after the FPGA module collects the actual power value and changes, it compensates by adjusting the output voltage of the Bulk power supply, thereby ensuring the stability of the power output; The digital communication interface uses low voltage differential signaling to transmit control data between the backplane and the FPGA control logic; A switch is provided between the communication backplane and the low-voltage adjustable DC power supply, for interrupting the output of radio frequency energy and cutting off the power supply of the power part when the current and voltage are overloaded.

2. The device according to claim 1, characterized in that The data exchange between the communication backplane and the computer is carried out based on a wired network, an optical fiber or a wireless network.

3. The device according to claim 1, characterized in that The power supply module is in the form of a high-frequency switching power supply or an industrial frequency rectification form.

4. The device according to claim 1, characterized in that The output power of the power inverter is 0-100W.

5. The device according to claim 1, characterized in that The device includes an external foot switch for controlling the operation or termination of radio frequency excitation.

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