Signal generator for tissue modification system

Abstract

This invention relates to a signal generator, a system including the signal generator, and related methods. The signal generator includes a capacitor storing energy for generating a processed signal. The signal generator also includes a waveform shaping circuit, a controller, a voltage sensing circuit, and a current sensing circuit. The waveform shaping circuit is coupled to the capacitor and includes a first switch, a second switch, a third switch, and a fourth switch, each configured to selectively turn on and off such that current flows through the switch when it is on and current is blocked when it is off. The controller selectively controls the switches to generate the processed signal. The controller also selectively controls the switches to perform certain fault tests that depend on a voltage sensed by the voltage sensing circuit and a current sensed by the current sensing circuit.

Description

Technical Field

[0001] Some embodiments of this technology relate to signal generators used in processing systems such as tissue modification systems, and to processing systems that include signal generators. Some embodiments of this technology also relate to methods used by signal generators and / or by processing systems that include signal generators.

[0002] Priority requirements

[0003] This application claims priority to U.S. Provisional Patent Application No. 63 / 077,022, filed September 11, 2020, and U.S. Non-Provisional Patent Application No. 17 / 227,232, filed April 9, 2021, which are incorporated herein by reference. Background Technology

[0004] Pulsed electric field therapy can be used to deliver high-voltage, short-duration pulses to affect various intracavitary structures (airway and gastrointestinal tract), unresectable tissue targets (liver, pancreas, lung, and kidney), or diseased tissue in cancerous solid tumors. Signal generators are typically used to generate the pulsed electric field signals for this tissue treatment therapy. Due to the short duration of the pulses used to deliver the treatment, signal generators typically include a switching network containing solid-state electronics. The signal generator can use its switching network to generate a biphasic processing signal comprising both positive and negative pulses. Alternatively, the signal generator can use its switching network to generate a single-phase pulse. The solid-state switches in the signal generator can sometimes fail and introduce reliability issues due to the high voltage and current that may be present under low impedance conditions. Summary of the Invention

[0005] According to embodiments of the present technology, a signal generator includes one or more capacitors coupled between a high-voltage rail and a low-voltage rail, configured to store energy that can be used to selectively generate a processed signal. The signal generator also includes waveform shaping circuitry, a controller, voltage sensing circuitry, and current sensing circuitry. The waveform shaping circuitry is coupled to the one or more capacitors and includes a first switch, a second switch, a third switch, and a fourth switch, each configured to selectively turn on and off, and each switch is configured to allow current to flow through the switch when it is on and to prevent current from flowing through the switch when it is off. The controller is configured to selectively control the switches to selectively turn on a first pair of switches and turn off a second pair of switches during a first time period, and to selectively turn off the first pair of switches and turn on the second pair of switches during a second time period to generate a processed signal. The voltage sensing circuitry is configured to sense a voltage stored in the one or more capacitors. The current sensing circuitry is configured to sense a current having an amplitude characterizing the amplitude of the current flowing through a pair of switches turned on by the controller.

[0006] According to some embodiments, the controller is further configured to: selectively perform a first fault test on the signal generator, wherein during the first fault test, a first pair of switches is turned on and a second pair of switches is turned off; determine that the signal generator has passed the first fault test in response to a voltage sensed by a voltage sensing circuit being lower than a specified voltage threshold and a current amplitude sensed by a current sensing circuit being higher than a specified current threshold; and determine that the signal generator has failed the first fault test in response to a current amplitude sensed by a current sensing circuit being lower than a specified current threshold.

[0007] According to some embodiments, as part of a first fault test, the controller is configured to: determine that at least one switch in a first pair of switches is stuck in an open state in response to a current amplitude sensed by a current sensing circuit being lower than a specified current threshold and a voltage sensed by a voltage sensing circuit being higher than a specified voltage threshold; and determine that at least one switch in a second pair of switches is stuck in an on state in response to a current amplitude sensed by a current sensing circuit being lower than a specified current threshold and a voltage sensed by a voltage sensing circuit being lower than a specified voltage threshold.

[0008] According to some embodiments, the controller is further configured to: selectively perform a second fault test on the signal generator, wherein during the second fault test, a first pair of switches is open and a second pair of switches is closed; determine that the signal generator has passed the second fault test in response to a voltage sensed by the voltage sensing circuit being lower than a specified voltage threshold and a current amplitude sensed by the current sensing circuit being higher than a specified current threshold; and determine that the signal generator has failed the second fault test in response to a current amplitude sensed by the current sensing circuit being lower than a specified current threshold.

[0009] According to some embodiments, as part of a second fault test, the controller is configured to: determine that at least one switch in the second pair of switches is stuck in the open state in response to a current amplitude sensed by the current sensing circuit being lower than a specified current threshold and a voltage sensed by the voltage sensing circuit being higher than a specified voltage threshold; and determine that at least one switch in the first pair of switches is stuck in the closed state in response to a current amplitude sensed by the current sensing circuit being lower than a specified current threshold and a voltage sensed by the voltage sensing circuit being lower than a specified voltage threshold.

[0010] According to some embodiments, the controller is configured to perform at least one of a first fault test and a second fault test in response to the signal generator being energized.

[0011] According to some embodiments, the controller is implemented by at least one of a processor or a field-programmable gate array (FPGA).

[0012] According to some embodiments, a first switch and a second switch are connected in series in a first branch of the waveform shaping circuit, and a third switch and a fourth switch are connected in series in a second branch of the waveform shaping circuit, wherein the first branch and the second branch are connected in parallel with each other. A first output node of the waveform shaping circuit is located between the first and second switches, and a second output node of the waveform shaping circuit is located between the third and fourth switches. A first pair of switches includes the first switch and the fourth switch, and a second pair of switches includes the second switch and the third switch. According to a particular embodiment, the first switch is connected between the high-voltage rail and the first output node; the second switch is connected between the first output node and the low-voltage rail; the third switch is connected between the high-voltage rail and the second output node; and the fourth switch is connected between the second output node and the low-voltage rail.

[0013] According to some embodiments, the signal generator further includes a transformer comprising a first primary winding, a second primary winding, and a secondary winding, wherein the first primary winding and the second primary winding are connected in parallel with each other and coupled between a first output node and a second output node of a waveform shaping circuit, and wherein a current sensed by a current sensing circuit is generated in response to an induced voltage in the secondary winding, the current being used to generate a processing signal applied to the patient's tissue.

[0014] Some embodiments of this technology relate to a method used by a signal generator, the signal generator comprising: one or more capacitors configured to store energy that can be used to selectively generate a processed signal; and a waveform shaping circuit coupled to the one or more capacitors and including a first switch, a second switch, a third switch, and a fourth switch, each switch being configured to selectively turn on and off, and each switch being configured to allow current to flow through the switch when the switch is on, and to prevent current from flowing through the switch when the switch is off. The method includes: performing a first fault test on the signal generator, wherein during the first fault test, a first pair of switches is turned on and a second pair of switches is turned off; as part of the first fault test, sensing a first voltage stored on the one or more capacitors; as part of the first fault test, sensing a first current, the magnitude of which characterizes the magnitude of the current flowing through the turned-on first pair of switches; and determining whether the signal generator has passed the first fault test based on the first voltage stored on the one or more capacitors and based on the first current sensed as part of the first fault test, the magnitude of which characterizes the magnitude of the current flowing through the turned-on first pair of switches.

[0015] According to some embodiments, determining whether a signal generator passes a first fault test includes: determining that the signal generator has passed the first fault test in response to a first voltage sensed as part of the first fault test being lower than a specified voltage threshold and a first current sensed as part of the first fault test having an amplitude higher than a specified current threshold.

[0016] According to some embodiments, determining whether a signal generator passes a first fault test includes: determining that the signal generator fails the first fault test in response to the amplitude of a first current sensed by a current sensing circuit being lower than a specified current threshold. According to some embodiments, determining that the signal generator fails the first fault test further includes: determining that at least one switch in a first pair of switches is stuck in an open state in response to the amplitude of a first current sensed as part of the first fault test being lower than a specified current threshold and the first voltage sensed as part of the first fault test being higher than a specified voltage threshold; or determining that at least one switch in a second pair of switches is stuck in an on state in response to the amplitude of a first current sensed as part of the first fault test being lower than a specified current threshold and the first voltage sensed as part of the first fault test being lower than a specified voltage threshold.

[0017] According to some embodiments, the method further includes performing a second fault test on the signal generator, wherein, during the second fault test, a first pair of switches is disconnected and a second pair of switches is turned on; as part of the second fault test, a second voltage stored on the one or more capacitors is sensed; as part of the second fault test, a second current is sensed, the magnitude of which characterizes the magnitude of the current flowing through the turned-on second pair of switches; and based on the second voltage stored on the one or more capacitors, and based on the second current sensed as part of the second fault test, the magnitude of which characterizes the magnitude of the current flowing through the turned-on second pair of switches, it is determined whether the signal generator has passed the second fault test.

[0018] According to some embodiments, determining whether a signal generator passes a second fault test includes: determining that the signal generator has passed the second fault test in response to a second voltage sensed as part of the second fault test being lower than a specified voltage threshold and a current amplitude sensed as part of the second fault test being higher than a specified current threshold.

[0019] According to some embodiments, determining whether a signal generator passes a second fault test includes: determining that the signal generator fails the second fault test in response to the amplitude of a second current sensed as part of the second fault test being lower than a specified current threshold.

[0020] According to some embodiments, determining that the signal generator failed the second fault test further includes: determining that at least one switch in the second pair of switches is stuck in the off state in response to the amplitude of the second current sensed as part of the second fault test being lower than a specified current threshold and the second voltage sensed as part of the second fault test being higher than a specified voltage threshold; or determining that at least one switch in the first pair of switches is stuck in the on state in response to the amplitude of the second current sensed as part of the second fault test being lower than a specified current threshold and the second voltage sensed as part of the second fault test being lower than a specified voltage threshold.

[0021] According to some embodiments, the signal generator includes one or more capacitors configured to store energy that can be used to selectively generate a processed signal. The signal generator also includes a switch network comprising a first switch, a second switch, a third switch, and a fourth switch, wherein the first and second switches are connected in series with each other and in parallel with the one or more capacitors, and the third and fourth switches are connected in series with each other and in parallel with the one or more capacitors. Each of the first, second, third, and fourth switches is configured to selectively turn on and off, configured to allow current to flow through the switch when it is on, and configured to prevent current from flowing through the switch when it is off. The signal generator also includes a controller configured to selectively control the switches to selectively turn on the first and fourth switches and turn off the second and third switches during a first time period, and to selectively turn off the first and fourth switches and turn on the second and third switches during a second time period to generate a processed signal. In addition, the signal generator includes a voltage sensing circuit and a current sensing circuit, wherein the voltage sensing circuit is configured to sense the voltage stored on the one or more capacitors, and the current sensing circuit is configured to sense a current having an amplitude that characterizes the amplitude of the current flowing through a pair of switches turned on by the controller.

[0022] In some embodiments, the controller is further configured to selectively perform a first fault test on the signal generator, wherein during the first fault test, a first switch and a fourth switch are turned on and a second switch and a third switch are turned off; the signal generator is determined to have passed the first fault test in response to a voltage sensed by a voltage sensing circuit being lower than a specified voltage threshold and a current amplitude sensed by a current sensing circuit being higher than a specified current threshold; and the signal generator is determined to have failed the first fault test in response to a current amplitude sensed by a current sensing circuit being lower than a specified current threshold.

[0023] In some embodiments, the controller is further configured to: selectively perform a second fault test on the signal generator, wherein during the second fault test, the first and fourth switches are open and the second and third switches are closed; determine that the signal generator has passed the second fault test in response to a voltage sensed by the voltage sensing circuit being lower than a specified voltage threshold and a current amplitude sensed by the current sensing circuit being higher than a specified current threshold; and determine that the signal generator has failed the second fault test in response to a current amplitude sensed by the current sensing circuit being lower than a specified current threshold.

[0024] According to some embodiments, the signal generator further includes a first output node between a first switch and a second switch; a second output node between a third switch and a fourth switch; and a transformer including a first primary winding, a second primary winding, and a secondary winding. In some such embodiments, the first primary winding and the second primary winding are connected in parallel with each other and coupled between the first output node and the second output node. Furthermore, in response to an induced voltage in the secondary winding, a current sensed by a current sensing circuit is generated, which is used to generate a processing signal applied to the patient tissue.

[0025] This invention is not a complete description of the embodiments of the present technology. Other features and advantages of the embodiments of the present technology will become apparent in the following description, wherein preferred embodiments are set forth in detail with reference to the accompanying drawings and claims. Attached Figure Description

[0026] Figure 1A An exemplary treatment system for treating patients is shown.

[0027] Figure 1B It was shown that initially in Figure 1A A schematic diagram of an embodiment of the processing system described herein.

[0028] Figure 2A An embodiment of the present technology is shown in Figure 1A and Figure 1B The circuit diagram of the output signal generator circuit of the signal generator described in the article.

[0029] Figure 2B Including with Figure 2A The same circuit diagram described herein is used to explain how a first fault test is performed on the switching network of a signal generator according to embodiments of the present technology.

[0030] Figure 2C Including with Figure 2A The same circuit diagram described herein is used to explain how a second fault test is performed on the switching network of a signal generator according to embodiments of the present technology.

[0031] Figure 3 shows an example of the waveform of the biphase processed signal as defined by the energy transfer algorithm.

[0032] Figure 4 shows the result of... Figure 2A The circuit described herein generates a signal from its controller, which is used to control the switch to produce a two-phase processing signal.

[0033] Figure 5A The diagram shows the generalization of execution in Figure 2B The flowchart of the first fault test method introduced in the article is as follows.

[0034] Figure 5BThe diagram shows the generalization of execution in Figure 2C The flowchart of the second fault test method described in the article is as follows.

[0035] Figure 5C A summary flowchart for the generalization method is shown, which is used to determine in Figure 2B and Figure 5A The reasons why the first fault test failed, as discussed in the article.

[0036] Figure 5D A summary flowchart for the generalization method is shown, which is used to determine in Figure 2C and Figure 5B The reason why the second fault test failed, as discussed in the article. Detailed Implementation

[0037] Some embodiments of this technology relate to signal generators for use in processing systems such as tissue modification systems, but are not limited thereto. Figure 1A An example of a treatment system 100 for treating patients is shown. Figure 1B Is Figure 1A The diagram illustrates an embodiment of the processing system. In this embodiment, system 100 includes a therapeutic energy delivery device 102 (e.g., a catheter) connectable to a signal generator 104. The signal generator 104 may be more simply referred to herein as generator 104. (See also...) Figure 1A The device 102 is shown to have an elongated shaft 106 with at least one energy transfer element 108 near its distal end and a gripping portion 110 at its proximal end. The device 102 can be connected to a generator 104 as part of a processing system 100. Among other features, the connection of the device 102 to the generator 104 provides electrical energy to the energy transfer element 108. In this embodiment, the energy transfer element 108 comprises a plurality of filaments or strips 120 constrained by a proximal constraint 122 and a distal constraint 124, and forms a helical frame shape serving as electrodes. In an alternative embodiment, the filaments or strips are straight rather than helical (i.e., configured to form a straight frame shape). In yet another embodiment, the energy transfer element 108 is formed from a tubing by laser cutting. It should be understood that a variety of other designs can be used. For example, the energy transfer element 108 may be paddle-shaped and comprise multiple filaments or strips arranged to form a flat pad-like or paddle-like structure. Such an energy transfer element 108 is flexible so as to retract into the shaft 106. Still referring to... Figure 1AIn this embodiment, the energy transfer element 108 is self-expanding and is transferred to the target region in a collapsed configuration. This collapsed configuration can be achieved, for example, by placing a sheath 126 on the energy transfer element 108. The device axis 106 (within the sheath 126) terminates at a proximal constraint 122, such that the distal constraint 124 is substantially unconstrained axially and free to move relative to the axis 106 of the device 102. Advancing the sheath 126 on the energy transfer element 108 allows the distal constraint 124 to move forward, thereby elongating / collapsed and constraining the energy transfer element 108. The energy transfer element 108 may also be referred to herein as an energy transfer electrode 108, an active electrode 108, or more simply as an electrode 108.

[0038] As shown in this example, the device 102 includes a grip 110 at its proximal end. In some embodiments, the grip 110 is removable, for example, by pressing a grip removal button 130. In this embodiment, the grip 110 includes an energy transfer element operating knob or actuator 132, wherein movement of the actuator 132 causes expansion or retraction / collapse of the frame electrode. In this example, the grip 110 also includes a working port latch 134 for optional connection to an endoscope or other type of visualization device and a cable insertion port 136 for connection to the generator 104. It should be understood that various types of visualization techniques can be used, including angiography (optionally including markers), computed tomography, optical coherence tomography, ultrasound imaging, and direct video visualization, etc.

[0039] In this embodiment, the therapeutic energy delivery device 102 can be connected to the generator 104 and discrete (return) electrodes 140 applied to the patient's skin. Therefore, in this embodiment, unipolar energy delivery is achieved by providing energy between the energy delivery element 108 positioned near the distal end of the device 102 and the return electrode 140. However, it should be understood that bipolar energy delivery and other arrangements can be used alternatively. When using bipolar energy delivery, the therapeutic energy delivery device 102 can differ in its overall design, for example, including multiple energy delivery elements 108, or the therapeutic energy delivery device 102 can appear similar in its overall design, for example, including a single energy delivery element 108 configured to operate in a bipolar manner. In some cases, bipolar energy delivery allows for the use of lower voltages to achieve the treatment effect compared to unipolar energy delivery. In a bipolar configuration, the positive and negative electrodes are sufficiently close to provide the treatment effect together between the electrode ends. Compared to unipolar, this allows the treatment effect to be propagated over a larger, shallower surface area, thus requiring a lower voltage to achieve the treatment effect. Similarly, this lower voltage can be used to reduce the depth of penetration. Furthermore, if the voltage delivered is low enough to avoid stimulating myocardial cells, then in certain situations, the lower voltage requirement can eliminate the need for cardiac synchronization techniques.

[0040] In this embodiment, generator 104 includes a user interface 150, one or more energy transfer algorithms 152, a processor 154, a data storage / retrieval unit 156 (e.g., a memory and / or database), and an energy storage and output subsystem 158 that generates and stores the energy to be transferred and generates the desired waveform of the energy to be transferred. In some embodiments, one or more capacitors are used to store / transfer energy; however, any other suitable energy storage element may be used. In some embodiments, multiple switches are used to generate the desired waveform of the energy to be transferred. Energy storage and output subsystem 158 may also be referred to as output signal generator circuit 158, or more simply as circuit 158. Furthermore, the generator may include one or more communication ports 167.

[0041] In some embodiments, generator 104 includes three subsystems: 1) a high-energy storage system, 2) a high-voltage intermediate-frequency switching amplifier, and 3) a system controller, firmware, and user interface. The system controller includes a cardiac synchronization trigger monitor that allows the pulse energy output to be synchronized with the patient's heart rhythm. The generator uses an alternating current (AC) power supply to power multiple direct current (DC) powered devices. The generator's controller enables the DC powered devices to charge the high-energy capacitor storage stack before energy transfer begins. At the start of processing the energy transfer, the generator's controller, high-energy storage stack, and biphase pulse amplifier can operate simultaneously to generate a high-voltage intermediate-frequency output.

[0042] It should be understood that various generator electrical architectures can be employed to execute energy transfer algorithms. In particular, in some embodiments, advanced switching systems are used that can cyclically direct pulsed electric fields to energy transfer electrodes separate from the same energy storage and high-voltage transfer systems. Furthermore, in advanced energy transfer algorithms employing rapidly changing pulse parameters (e.g., voltage, frequency, etc.), the generator or multiple energy transfer electrodes can utilize modular energy storage and / or high-voltage systems, thereby facilitating highly customizable waveform and geographic pulse transfer paradigms. It should also be understood that the electrical architectures described above are merely exemplary, and systems for transferring pulsed electric fields may or may not include additional switching amplifier components.

[0043] User interface 150 may include a touchscreen and / or more conventional buttons to allow the operator to input patient data, select a processing algorithm (e.g., energy transfer algorithm 152), initiate energy transfer, view records stored on storage / retrieval unit 156, and / or otherwise communicate with generator 104. User interface 150 may include a voice activation mechanism for inputting patient data, or may be able to communicate with additional devices in the kit to control generator 104 via a secondary, separate user interface.

[0044] In some embodiments, the user interface 150 is configured to receive operator-defined input. Operator-defined input may include the duration of energy delivery, one or more other time aspects of the energy delivery pulse, power and / or operating mode, or combinations thereof. Example operating modes may include (but are not limited to): system startup and self-test, operator input, algorithm selection, pre-processing system status and feedback, energy delivery, post-energy delivery display or feedback, processing data retrieval and / or download, software update, or any combination or sub-combination thereof. According to some embodiments, during automated treatment delivery, the user interface 150 displays information to a physician or technician or other users, wherein all the aforementioned dosage parameters (e.g., the duration of energy delivery, one or more other time aspects of the energy delivery pulse, power and / or operating mode, or combinations thereof) may be preset. The user interface 150 may also be used to provide system status after one or more self-tests and may provide users with a way to be aware of system status information.

[0045] In some embodiments, system 100 further includes a mechanism for acquiring an electrocardiogram (ECG), such as an external cardiac monitor 170. Examples of cardiac monitors are available from AccuSync Medical Research, Inc. In some embodiments, the external cardiac monitor 170 is operatively connected to generator 104. The cardiac monitor 170 can be used to continuously acquire ECG signals. External electrodes 172 can be applied to a patient to acquire an ECG. Generator 104 analyzes one or more cardiac cycles and identifies the start of a time period in which energy can be safely applied to the patient, thereby providing the ability to synchronize energy delivery with the cardiac cycle. In some embodiments, this time period is within the R wave (of the ECG QRS complex) of several milliseconds to avoid inducing arrhythmias, which could be induced if energy pulses were delivered on the T wave. It should be understood that this cardiac synchronization is typically utilized when using unipolar energy delivery; however, this cardiac synchronization can also be used as part of other energy delivery methods.

[0046] In some embodiments, among other activities, processor 154 also modifies energy transfer algorithms and / or switches between energy transfer algorithms, monitors energy transfer and any sensing data, and reacts to the monitored data via a feedback loop. In some embodiments, processor 154 is configured to execute one or more algorithms for operating a feedback control loop based on one or more measured system parameters (e.g., current), one or more measured tissue parameters (e.g., impedance), and / or combinations thereof.

[0047] The data storage / retrieval unit 156 stores data, for example, data related to the transmitted processing, and can optionally be downloaded by connecting a device (e.g., a laptop or USB flash drive) to the communication port. In some embodiments, the device has local software for guiding the download of information, such as instructions stored on the data storage / retrieval unit 156 and executable by the processor 154. In some embodiments, the user interface 150 allows an operator to select to download data to a device and / or system, such as, but not limited to, a computer device, tablet, mobile device, server, workstation, cloud computing device / system, and / or the like. A communication port that can permit wired and / or wireless connections can allow data downloads, as described above, but can also allow data uploads, such as uploading custom algorithms or providing software updates.

[0048] The data storage / retrieval unit 156 may be, for example, random access memory (RAM), buffer memory, hard disk drive, database, erasable programmable read-only memory (EPROM), electrically erasable read-only memory (EEPROM), read-only memory (ROM), flash memory, etc. The data storage / retrieval unit 156 may store instructions that cause the processor 154 to execute modules, processes, and / or functions associated with the system 100.

[0049] In some embodiments, the data storage / retrieval unit 156 includes a computer storage product having a non-transient computer-readable medium (also referred to as a non-transient processor-readable medium) containing instructions or computer code for performing various computer-implemented operations. A computer-readable medium (or processor-readable medium) is non-transient in the sense that it does not contain transiently propagating signals (e.g., propagating electromagnetic waves carrying information in transmission media such as space or cables). The medium and computer code (also referred to as code) can be those media and computer code designed and architected for a particular purpose. Examples of non-transient computer-readable media include, but are not limited to: magnetic storage media, such as hard disks, floppy disks, and magnetic tapes; optical storage media, such as compact discs / digital video discs (CD / DVD), read-only compact discs (CD-ROM), and holographic devices; magneto-optical storage media, such as optical discs; carrier signal processing modules; and hardware devices specifically configured to store and execute program code, such as ASICs, programmable logic devices (PLDs), read-only memory (ROM), and random access memory (RAM) devices. Other embodiments described herein relate to computer program products that may include, for example, instructions and / or computer code discussed herein.

[0050] Examples of computer code include, but are not limited to, microcode or microinstructions, such as machine instructions generated by a compiler, code for generating World Wide Web services, and files containing high-level instructions that a computer executes using an interpreter. For example, embodiments may be implemented using imperative programming languages ​​(e.g., C, Fortran, etc.), functional programming languages ​​(Haskell, Erlang, etc.), logic programming languages ​​(e.g., Prolog), object-oriented programming languages ​​(e.g., Java, C++, etc.), or other suitable programming languages ​​and / or development tools. Other examples of computer code include, but are not limited to, control signals, encryption code, and compression code.

[0051] In some embodiments, system 100 may be communicatively coupled to a network, which may be any type of network, such as a local area network (LAN), wide area network (WAN), virtual network, telecommunications network, data network, and / or the Internet implemented as a wired and / or wireless network. In some embodiments, any or all communication may be secured using any suitable type and / or method of secure communication (e.g., Secure Sockets Layer (SSL)) and / or encryption. In other embodiments, any or all communication may be unsecured.

[0052] Figure 1B It was the first time in Figure 1A A schematic diagram of an embodiment of the processing system 100 described herein. In this embodiment, a discrete (neutral) electrode or return electrode 140 is operatively connected to the generator 104 and secured to the patient's skin to provide a return path for energy delivered via the device 102. The energy delivery device 102 includes one or more energy delivery elements 108 (composed of electrodes), one or more sensors 160, one or more imaging modalities 162, one or more buttons 164, and / or positioning mechanisms 166 (e.g., such as, but not limited to, a lever and / or control panel with traction wires on a grip, a telescopic tube, a sheath, etc.), wherein the one or more energy delivery elements 108 are in contact with tissue. In some embodiments, a foot switch 168 is operatively connected to the generator 104 and used to initiate energy delivery. The discrete electrode 140 may also be referred to herein as a neutral electrode 140, a return electrode 140, or more simply as electrode 140.

[0053] As previously described, the user interface 150 may include a touchscreen and / or more conventional buttons to allow the operator to input patient data, select processing algorithm 152, initiate energy transfer, view records stored in storage / retrieval unit 156, or otherwise communicate with generator 104. Processor 154 manages and executes the energy transfer algorithm, monitors energy transfer and any sensor data, and reacts to the monitored data via feedback loops. Data storage / retrieval unit 156 stores data related to the transferred processing and can be downloaded by connecting a device (e.g., a laptop or USB flash drive) to communication port 167.

[0054] Instrument 102 is operatively connected to generator 104 and / or a separate imaging screen 180. Imaging modality 162 may be incorporated into, or used in conjunction with, instrument 102. Alternatively or additionally, a separate imaging modality or device 169 may be used, such as a commercially available system (e.g., a bronchoscope). This separate imaging device 169 may be mechanically, operatively, and / or communicatively coupled to instrument 102 using any suitable mechanism.

[0055] Figure 2A This is a circuit diagram of the output signal generator circuit 158 ​​of the signal generator 104 according to an embodiment of the present technology. (See reference) Figure 2A Circuit 158 ​​is shown as including a high-voltage (HV) power supply device 202, a controller 204, an HV capacitor 206, a waveform shaping circuit 208, a transformer 210, a filter 220, a DC blocking capacitor 222, a voltage sensing circuit 226, a current sensing circuit 228, and a calibration resistor Rcal. Voltage sensing circuit 226 and current sensing circuit 228 are part of a fault detector 230, which will be described in more detail below. As those skilled in the art will appreciate, circuit 158 ​​may include additional circuit networks not shown.

[0056] HV power supply device 202 is configured to selectively provide a high-voltage DC signal for charging HV capacitor 206 to a desired voltage level. In some embodiments, voltage sensing circuitry 226 may be used to determine when HV capacitor 206 is charged to the desired voltage level, but this is not necessary. HV power supply device 202 may include, for example, an AC / DC converter that receives alternating current (AC) and holds and outputs a direct current (DC) signal. HV power supply device 202 may also include a boost regulator or buck regulator that receives the output of the AC / DC converter, converts the output of the AC / DC converter to the desired voltage level, and holds the voltage level at the desired level. As will be understood by those skilled in the art, HV power supply device 202 may include additional and / or alternative circuit networks. Switch Sp is used to selectively connect HV power supply device 202 to HV capacitor 206. As an alternative or additional solution to using switch Sp to control whether HV power supply device 202 charges HV capacitor 206, the output of HV power supply device 202 can be selectively enabled and disabled by controller 204, thereby selectively controlling whether HV capacitor 206 is charged by HV power supply device 202 at any given time. Accordingly, if the output of HV power supply device 202 can be selectively enabled and disabled by controller 204, switch Sp can be optionally omitted.

[0057] HV capacitor 206 includes one or more HV capacitors for storing energy used to generate a processing signal, which is delivered to the patient via electrode 108 and electrode 140 or some other electrodes. HV capacitor 206 may be implemented using a stack of capacitors connected in series and / or in parallel with each other, depending on the specific implementation.

[0058] The waveform shaping circuit 208 is shown as including current-limiting resistors Ra1, Ra2, Rb1, and Rb2, and switches Sa1, Sa2, Sb1, and Sb2. These switches are controlled by a controller 204, which may be controlled by a processor (e.g., Figure 1A and Figure 1B The processor 154, FPGA, or similar is used for implementation. According to some embodiments, each of switches Sa1, Sa2, Sb1, and Sb2 is implemented using a corresponding insulated-gate bipolar transistor (IGBT). If each switch is implemented using a corresponding IGBT, each switch may include or be associated with a corresponding IGBT driver (not shown), as understood by those skilled in the art. Each such IGBT driver can selectively turn on (i.e., close) or turn off (i.e., open) a corresponding IGBT type switch in response to a signal received from controller 204. The output nodes of waveform shaping circuit 208, labeled output 1 and output 2, are connected to transformer 210.

[0059] Transformer 210 is used to boost the voltage signal generated between the output nodes (output 1 and output 2) of waveform shaping circuit 208 to the desired level. Transformer 210 also serves to isolate HV power supply device 202 and waveform shaping circuit 208 from electrodes 108 and 140. Figure 2A In the diagram, the primary side of the transformer is shown as comprising two parallel windings 212 and 214, and the secondary side is shown as comprising a single winding 216. In the illustrated embodiment, each of the primary windings 212 and 214 has 14 turns, and the secondary winding 216 has 30 turns, meaning that the transformer is an approximately 1:2 step-up transformer. However, the primary and secondary windings may also have different numbers of turns to provide different step-up (or step-down) ratios.

[0060] Turning a switch on, as used herein, does not necessarily mean that the switch is actually on, as the switch may be stuck in the off position and therefore not respond to being turned on. Similarly, turning a switch off, as used herein, does not necessarily mean that the switch is actually off, as the switch may be stuck in the on position and therefore not respond to being turned off. As will be described in more detail below, according to certain embodiments of the present technology, the fault tests described herein can be used to determine whether a switch is stuck in the on or off state.

[0061] Filter 220, shown as an RC snubber circuit comprising a resistor and a capacitor connected in series, is used to filter out high-frequency transients or ringing that may be caused by leakage inductance of transformer 210. DC blocking capacitor 222 is used to prevent dangerous low-frequency currents or DC currents from flowing through patient tissue. During self-testing, a calibrated resistor Rcal with a known (i.e., predetermined) resistance value having very tight tolerances can be used to verify that the voltage sensing circuit 226 and current sensing circuit 228 are functioning properly by measuring the voltage and current flowing through this known resistor (i.e., Rcal). Switch Sc is used to connect the calibrated resistor Rcal. Figure 2A The circuit shown is followed by the disconnection of the resistor from the circuit.

[0062] Figure 3 illustrates an embodiment of the waveform 300 of the processed signal defined by the energy transfer algorithm 152. Waveform 300 may also be referred to as biphase processed signal 300, or more simply as processed signal 300. In Figure 3, one packet 302 is shown. However, waveform 300 may also include one or more additional packets (not shown), wherein pairs of packets are separated from each other by rest periods. In this embodiment, packet 302 includes a first biphase cycle (including a first positive pulse peak 308 and a first negative pulse peak 310), a second biphase cycle (including a second positive pulse peak 308' and a second negative pulse peak 310'), and an nth biphase cycle (including an nth positive pulse peak 308" and an nth negative pulse peak 310"), where n is an integer greater than or equal to 3. The first and second biphase pulses are separated by a no-signal time 312 (i.e., an interval) between each pulse. In this embodiment, the biphase pulses are symmetrical, such that the set voltage 316p of the positive peak is the same as the set voltage 316n of the negative peak; however, this is not mandatory. Here, the biphase, symmetrical wave is also a square wave, such that the amplitude and time of the positive voltage wave are approximately equal to the amplitude and time of the negative voltage wave; however, this is not necessary.

[0063] When a bipolar configuration is used to apply a processing signal, the cellular portions facing the negative voltage wave (e.g., airway wall cells) undergo cell depolarization in these regions, during which the normally negatively charged cell membrane regions briefly become positively charged. Conversely, the cellular portions facing the positive voltage wave undergo hyperpolarization, during which the potential of the cell membrane regions becomes extremely negative. When used to treat the airway walls of a patient's lungs, it should be understood that in the respective positive or negative phases of the biphasic pulse, the portions of the airway wall cells will experience opposite effects. For example, the cell membrane portions facing the negative voltage will undergo depolarization, while the portions 180° to that portion will undergo hyperpolarization. In some embodiments, the hyperpolarized portions face the discrete electrode or return electrode 140.

[0064] The voltage used and considered can be the top of a square wave, the peak of a sine wave or a sawtooth wave, or the RMS (root mean square) voltage of a sine wave or a sawtooth wave. In some embodiments, energy is transferred in a unipolar manner, and each high-voltage pulse or set voltage 316 is between about 500V and 10,000V, particularly between about 500V and 5000V, between about 500V and 4000V, between about 1000V and 4000V, between about 2500V and 4000V, between about 2000V and 3500V, between about 2000V and 2500V, and between about 2500V and 3500V, including all values ​​and sub-ranges between about 500V, 1000V, 1500V, 2000V, 2500V, 3000V, 3500V, and 4000V. In some embodiments, each high-voltage pulse is in the range of approximately 1000V to 2500V, and this high-voltage pulse can penetrate the airway wall W in a specific combination of parameters to treat or affect specific cells located at a slightly superficial level, such as epithelial cells. In some embodiments, each high-voltage pulse is in the range of approximately 2500V to 4000V, and this high-voltage pulse can penetrate the airway W in a specific combination of parameters to treat or affect specific cells located at a slightly deeper level, such as submucosal cells or smooth muscle cells.

[0065] It should be understood that the set voltage 316p and set voltage 316n may vary depending on the specific embodiment. In bipolar transfer, lower voltages can be used due to a smaller, more directional electric field. In some embodiments, energy is transferred bipolarly, and each pulse is between about 100V and 1900V, particularly between 100V and 999V, and more particularly between about 500V and 800V, such as 500V, 550V, 600V, 650V, 700V, 750V, and 800V. In other embodiments, energy is transferred bipolarly, and each pulse is between about 50V and 5000V, including 250V to 1500V.

[0066] The bipolar voltage used for treatment is selected based on the separation distance between the electrodes. However, for monopolar electrode configurations using far-dispersed plate electrodes, the bipolar voltage for treatment can be delivered with less consideration for the accurate placement of the catheter electrodes and the discrete electrodes on the body. In monopolar electrode embodiments, a larger voltage is typically used due to the discrete behavior of the energy delivered through the body to the discrete electrodes (on the order of 10 cm to 100 cm effective separation distance). Conversely, in bipolar electrode configurations, the relatively close proximity of the electrodes' effective areas, on the order of 0.5 mm to 10 cm, including 1 mm to 1 cm, results in a greater impact on energy concentration and the effective dose delivered to the tissue from the separation distance. For example, if the target voltage-distance ratio to achieve the desired clinical effect at an appropriate tissue depth (1 to 3 mm) is 3000 V / cm, then if the separation distance changes from 1 mm to 1.2 mm, this would result in the treatment voltage having to increase from 300 V to approximately 360 V, a change of 20%.

[0067] The number of biphasic cycles per second is the frequency. In some embodiments, biphasic pulses are used to reduce unwanted muscle stimulation, particularly myocardial stimulation. In other embodiments, the pulse waveform is monophasic and does not have a defined inherent frequency; alternatively, the fundamental frequency can be considered by doubling the length of the monophasic pulse to derive the frequency. In some embodiments, the signal has a frequency in the range of 100 kHz to 1 MHz, more specifically in the range of 100 kHz to 1000 kHz. In some embodiments, the signal has a frequency in the range of approximately 100 kHz to 600 kHz, which typically penetrates the airway to treat or affect specific cells located slightly deeper, such as submucosal cells or smooth muscle cells. In some embodiments, the signal has a frequency in the range of approximately 600 kHz to 1000 kHz or 600 kHz to 1 MHz, which typically penetrates the airway wall to treat or affect specific cells located slightly shallower, such as epithelial cells. It should be understood that at certain voltages, frequencies at or below 300 kHz may cause unwanted muscle stimulation. Therefore, in some embodiments, the signal has a frequency in the range of 400 kHz to 800 kHz or 500 kHz to 800 kHz, such as 500 kHz, 550 kHz, 600 kHz, 650 kHz, 700 kHz, 750 kHz, and 800 kHz. In particular, in some embodiments, the signal has a frequency of 600 kHz. Furthermore, cardiac synchronization is often utilized to reduce or avoid unwanted myocardial stimulation during sensitive rhythmic cycles. It should be understood that even higher frequencies can be used with components that minimize signal artifacts.

[0068] Figure 4 shows the result of Figure 2A Controller 204 in (e.g.) Figure 1A and Figure 1B The processor 154 generates signals to control switches Sa1, Sa2, Sb1, and Sb2 to produce the biphase processing signal 300 shown in Figure 3. The aforementioned switches collectively provide the switch network. In Figure 4, a rising phase 1 signal 402 controls switch Sa1, a falling phase 2 signal controls switch Sa2, a rising phase 2 signal 406 controls switch Sb1, and a falling phase 2 signal 408 controls switch Sb2. (Refer to...) Figure 2A In Figures 3 and 4, during the time interval between time point t1 and time point t2, the rising phase 1 signal 402 turns on switch Sa1 (i.e., closes it), the falling phase 1 signal 408 turns on switch Sb2 (i.e. closes it), the falling phase 2 signal 404 keeps switch Sa2 off (i.e. open), and the rising phase 2 signal 406 keeps switch Sb1 off (i.e. open), which produces the first positive pulse peak 308 shown in Figure 3.

[0069] During the time interval between time points t2 and t3, a rising phase 1 signal 402 causes switch Sa1 to open (i.e., be on), a falling phase 1 signal 408 causes switch Sb2 to open (i.e., be on), a falling phase 2 signal 404 causes switch Sa2 to close (i.e., be on), and a rising phase 2 signal 406 causes switch Sb1 to open (i.e., be on), resulting in the first negative pulse peak 310 shown in Figure 3. During the time interval between time points t3 and t4, a rising phase 1 signal 402 keeps switch Sa1 open (i.e., be on), a falling phase 1 signal 408 keeps switch Sb2 open (i.e., be on), a falling phase 2 signal 404 causes switch Sa2 to open (i.e., be on), and a rising phase 2 signal 406 causes switch Sb1 to open (i.e., be on), resulting in a signal-free period 312 following the first negative pulse peak 310, as shown in Figure 3. During the time interval between time points t4 and t5, the rising phase 1 signal 402 turns on switch Sa1 (i.e., closes it), the falling phase 1 signal 408 turns on switch Sb2 (i.e., closes it), the falling phase 2 signal 404 keeps switch Sa2 off (i.e., open it), and the rising phase 2 signal 406 keeps switch Sb1 off (i.e., open it), which produces the second positive pulse peak 308' shown in Figure 3. During the time interval between time points t5 and t6, the rising phase 1 signal 402 turns off switch Sa1 (i.e., opens it), the falling phase 1 signal 408 turns off switch Sb2 (i.e., opens it), the falling phase 2 signal 404 turns on switch Sa2 (i.e., closes it), and the rising phase 2 signal 406 turns on switch Sb1 (i.e., open it), which produces the second negative pulse peak 310' shown in Figure 3. During the time interval between time points t6 and t7, phase 1 rising signal 402 keeps switch Sa1 open (i.e., on), phase 1 falling signal 408 keeps switch Sb2 open (i.e., on), phase 2 falling signal 404 opens switch Sa2 (i.e., on), and phase 2 rising signal 406 opens switch Sb1 (i.e., on). This produces an additional no-signal period following the second negative pulse peak 310', as shown in Figure 3. Additional positive and negative pulse peaks (e.g., positive pulse peak 308" and negative pulse peak 310") and additional no-signal periods can be generated in a similar manner as desired.

[0070] from Figure 2AAs can be understood from the above discussion of Figures 3 and 4, in order to generate appropriate processing signals, such as the biphase processing signal 300 shown in Figure 3, various switches of the signal generator 104 (and more specifically, the energy storage and output subsystem 158), namely switches Sa1, Sa2, Sb1, and Sb2, must be properly operated. However, due to the high voltages these switches are subjected to, they can sometimes experience malfunctions, which may cause one or more of these switches to become stuck in the ON state (i.e., closed) and / or one or more switches to become stuck in the OFF state (i.e., open). To identify such potential malfunctions, the signal generator 104 can perform one or more fault tests to classify the fault states of the signal generator 104, thereby ensuring that the signal generator is operated properly. When a fault test identifies a fault, an error message can be generated, and in response to this error message, the signal generator 104 can be serviced (i.e., repaired) by a suitable technician.

[0071] More specifically, according to some embodiments, the signal generator 104 includes a fault detector 230, which includes a voltage sensing circuit 226 and a current sensing circuit 228, such as... Figure 2A As shown. The fault detector 230 may also include a controller 204 (e.g., processor 154, FPGA, or the like) for controlling switches Sa1, Sa2, Sb1, Sb2, voltage sensing circuit 226, and current sensing circuit 228 during a fault test. Furthermore, during the fault test, the controller 204 may obtain a voltage measurement from the voltage sensing circuit 226 and a current measurement from the current sensing circuit 228. If the fault test fails (i.e., fails to pass), a fault can be considered detected. The controller 204 may also determine whether a fault is detected based on such voltage and current measurements, which will be described in further detail below. The controller 204 may be configured to set multiple switches to predetermined states (e.g., test states) to allow fault states to be categorized. Fault tests may be performed when the signal generator 104 is powered on, for example for power-on self-test (POST) and / or at predetermined intervals or in response to certain events occurring during use, such as just before tissue ablation energy transfer and / or capacitor discharge, but are not limited thereto.

[0072] According to some embodiments, a first fault test and a second fault test are performed under the control of controller 204, and the HV capacitor 206 is charged before the first fault test by, for example, by turning on (i.e., closing) switch Sp for a period of time. Figure 2A As shown, and simultaneously switches Sa1, Sa2, Sb1, and Sb2 are all open (i.e., disconnected), as also... Figure 2AAs shown. Then, just before the first fault test is about to start, switch Sp is turned off (i.e., opened). During the first fault test, switches Sa1 and Sb2 are turned on (i.e. closed), switches Sa2 and Sb1 are turned off (i.e. open), and switch Sc is also turned on (i.e. closed), as shown. Figure 2B As shown. Assuming all switches are working properly, the current should flow along the path from... Figure 2B The current 232 flows along the path specified by the dashed line marked 232. When current 232 flows through the primary windings 212 and 214 of transformer 210, a secondary current is induced in the secondary winding 216 of transformer 210. This secondary current should flow along the path specified by the dashed line marked 232. Figure 2B The secondary current 234 flows along the path specified by the dashed line marked 234. This secondary current 234 causes current to flow through resistor Rcal, which is sensed by current sensing circuit 228 as part of the first fault test. Additionally, as part of the first fault test, voltage sensing circuit 226 senses voltage on the high-voltage rail of waveform shaping circuit 208. If voltage sensing circuit 226 senses a low voltage (i.e., a voltage below a specified voltage threshold) and current sensing circuit 228 senses a current (i.e., a current with an amplitude above a specified current threshold), then it is determined that signal generator 104 has passed the first fault test. However, if voltage sensing circuit 226 senses a high voltage (i.e., a voltage above a specified voltage threshold) and / or current sensing circuit 228 does not sense a current (more specifically, senses a current with an amplitude below a specified current threshold), then it is determined that signal generator 104 has failed the first fault test. In some embodiments, only whether the first fault test was passed or failed is determined. In other embodiments, the cause of failure to pass the first fault test can also be identified, which can be used by a technician or similar individual to repair the signal generator. Table 1 below clarifies the various types of faults that may cause a candidate to fail the first fault test.

[0073] Table 1

[0074]

[0075] Prior to the second fault test, HV capacitor 206 is charged by, for example, turning on (i.e. closing) switch Sp for a period of time, such as... Figure 2A As shown, and simultaneously switches Sa1, Sa2, Sb1, and Sb2 are all open (i.e., disconnected), as also... Figure 2A As shown. Then, just before the second fault test is about to start, switch Sp is turned off (i.e., opened). During the second fault test, switches Sa1 and Sb2 are turned off (i.e., opened), switches Sa2 and Sb1 are turned on (i.e. closed), and switch Sc is also turned on (i.e. closed), as shown. Figure 2C As shown. Assuming all switches are working properly, the current should flow along the path from... Figure 2C The current flows along the path specified by the dashed line marked 242. When current 242 flows through the primary windings 212 and 214 of transformer 210, a secondary current is induced in the secondary winding 216 of transformer 210. This secondary current should flow along the path specified by the dashed line marked 242. Figure 2C The secondary current 244 flows along the path specified by the dashed line marked 244. This secondary current 244 causes current to flow through resistor Rcal, which is sensed by current sensing circuit 228 as part of the second fault test. Additionally, as part of the second fault test, voltage sensing circuit 226 senses voltage on the high-voltage rail of waveform shaping circuit 208. If voltage sensing circuit 226 senses a low voltage (i.e., below a specified voltage threshold) and current sensing circuit 228 senses current (i.e., current with an amplitude above a specified current threshold), then signal generator 104 is determined to have passed the second fault test. However, if voltage sensing circuit 226 senses a high voltage (i.e., above a specified voltage threshold) and / or current sensing circuit 228 does not sense current (more specifically, senses a current with an amplitude below a specified current threshold), then signal generator 104 is determined to have failed the second fault test. In some embodiments, only passing the second fault test or failing the first fault test is determined. In other embodiments, the cause of failing the first fault test can also be identified, which a technician or similar individual can use to repair the signal generator. Table 2 below clarifies the various types of failures that may result in failing the second failure test.

[0076] Table 2

[0077]

[0078]

[0079] In the first fault test, the voltage sensed on the high-voltage rail is the same as the voltage sensed stored in the HV capacitor 206. Similarly, in the second fault test, the voltage sensed on the high-voltage rail is the same as the voltage sensed stored in the HV capacitor 206. Furthermore, since the first fault test fails if the sensed current is below a specified sensing threshold, failure of the first fault test can be detected solely based on the sensed current, without considering the sensed voltage. Similarly, since the second fault test fails if the sensed current is below a specified sensing threshold, failure of the second fault test can be detected solely based on the sensed current, without considering the sensed voltage.

[0080] Now for reference Figure 5A This diagram is used to summarize the above references. Figure 2B A summary flowchart of the method discussed for performing the first fault test. (Refer to...) Figure 5AStep 502 includes charging the HV capacitor used to selectively transmit processing signals to patient tissue. Step 504 includes turning on a first pair of switches (e.g., switches Sa1 and Sb2) and turning off a second pair of switches (e.g., switches Sa2 and Sb1). Steps 502 and 504 can be performed, for example, by controller 204. Step 502 can be considered separate from the first fault test; for example, this step can occur before the first fault test is initiated.

[0081] Step 506 includes sensing a first voltage stored in the HV capacitor. Step 506 can be performed by voltage sensing circuit 226 under the control of controller 204. As part of the first fault test, step 508 includes sensing a first current having an amplitude characterizing the amplitude of the current flowing through the first pair of switched-on switches (e.g., switch Sa1 and switch Sb2). Step 508 can be performed, for example, by current sensing circuit 228 under the control of controller 204. The order of steps 506 and 508 can be reversed, or steps 506 and 508 can be performed simultaneously.

[0082] Step 510 includes comparing a first voltage sensed as part of a first fault test with a specified voltage threshold. Step 512 includes comparing the magnitude of a first current sensed as part of a first fault test with a specified current threshold. The order of steps 510 and 512 may be reversed, or steps 510 and 512 may be performed simultaneously.

[0083] At step 514, it is determined whether the first voltage sensed as part of the first fault test is less than a specified voltage threshold, and whether the amplitude of the first current sensed as part of the first fault test is greater than a specified current threshold. Step 514 may consist of two or more steps.

[0084] If the answer to the content determined in step 514 is "yes," the process proceeds to step 516, and it is determined that the first fault test has been passed. In other words, the first fault test is passed if both of the following conditions are true: the first voltage sensed as part of the first fault test is lower than a specified voltage threshold, and the amplitude of the first current sensed as part of the first fault test is greater than a specified current threshold. If the first fault test is passed, the second fault test is performed. (See below for further details.) Figure 5B The details of the method used to perform the second fault test are discussed.

[0085] If the answer to the content determined in step 514 is "no," the process proceeds to step 518, where it is determined that the first fault test has failed. In other words, the first fault test fails if at least one of the following conditions is not true: the first voltage sensed as part of the first fault test is below a specified voltage threshold, or the amplitude of the first current sensed as part of the first fault test is greater than a specified current threshold. If the first fault test fails, the reason for the failure can be determined. (See below for further details.) Figure 5C The details of the methods used to determine why the first failure test failed are discussed.

[0086] Now for reference Figure 5B This diagram is used to summarize the above references. Figure 2C A summary flowchart of the method discussed for performing the second fault test. (Refer to...) Figure 5B Step 522 includes disconnecting the first pair of switches (e.g., switches Sa1 and Sb2) and connecting the second pair of switches (e.g., switches Sa2 and Sb1). Step 522 can be performed, for example, by controller 204.

[0087] Step 524 includes sensing a second voltage stored in the HV capacitor. Step 524 can be performed by voltage sensing circuit 226 under the control of controller 204. As part of a second fault test, step 526 includes sensing a second current having an amplitude characterizing the amplitude of the current flowing through the second pair of switched-on switches (e.g., switch Sa2 and switch Sb1). Step 526 can be performed, for example, by current sensing circuit 228 under the control of controller 204. The order of steps 524 and 526 can be reversed, or steps 524 and 526 can be performed simultaneously.

[0088] Step 528 includes comparing a second voltage sensed as part of a second fault test with a specified voltage threshold, which may be the same as, but is not required to be the same as, the voltage threshold mentioned in step 510. Step 530 includes comparing the amplitude of a second current sensed as part of a second fault test with a specified current threshold, which may be the same as, but is not required to be the same as, the current threshold mentioned in step 512. The order of steps 528 and 530 may be reversed, or steps 528 and 530 may be performed simultaneously.

[0089] At step 532, it is determined whether the second voltage sensed as part of the second fault test is less than a specified voltage threshold, and whether the amplitude of the second current sensed as part of the second fault test is greater than a specified current threshold. Step 5324 may consist of two or more steps.

[0090] If the answer to the content determined in step 532 is "yes," the process proceeds to step 534, and it is determined that the second fault test has been passed. In other words, the second fault test is passed if both of the following conditions are true: the second voltage sensed as part of the second fault test is below a specified voltage threshold, and the amplitude of the second current sensed as part of the second fault test is greater than a specified current threshold. If both the first and second fault tests are passed, the signal generator can be safely used to generate and transmit the processing signal to the patient tissue.

[0091] If the answer to the content determined in step 532 is "no," the process proceeds to step 536, where it is determined that the second fault test has failed. In other words, the second fault test fails if at least one of the following conditions is not true: the second voltage sensed as part of the second fault test is below a specified voltage threshold, or the amplitude of the second current sensed as part of the second fault test is greater than a specified current threshold. If the second fault test fails, the reason for the failure can be determined. (See below for further details.) Figure 5D The details of the method used to determine why the second failure test failed are discussed.

[0092] Figure 5C It is used to summarize and determine why it is referenced. Figure 2B and Figure 5A A summary flowchart of the method for handling the first failure test that fails (i.e., fails). Reference Figure 5C At step 542, it is determined whether the following conditions related to the first fault test are both true: the amplitude of the first current sensed by the current sensing circuit is lower than a specified current threshold; and the first voltage sensed by the voltage sensing circuit is higher than a specified voltage threshold. If the answer at step 542 is "yes," the process proceeds to step 544. At step 544, it is determined that at least one of the first pair of switches (e.g., switch Sa1 and switch Sb2) is stuck in the off state. Such information may be displayed or otherwise provided to physicians, technicians, or other users via a display, printout, or some other user interface.

[0093] If the answer to the determination at step 542 is "no", the process proceeds to step 546. At step 546, it is determined whether both of the following conditions related to the first fault test are true: the amplitude of the first current sensed by the current sensing circuit is below a specified current threshold; and the first voltage sensed by the voltage sensing circuit is below a specified voltage threshold. If the answer to the determination at step 546 is "yes", the process proceeds to step 548. At step 548, it is determined that at least one of the second pair of switches (e.g., switch Sa2 and switch Sb1) is stuck in the ON state. Such information may be displayed or otherwise provided to a physician, technician, or other user via a display, printout, or some other user interface. If the answer to the determination at step 546 is "no", the process proceeds to step 550, and the reason for the failure of the first fault test is uncertain. The order of steps 542 and 546 may be reversed.

[0094] Figure 5D It is used to summarize and determine why it is referenced. Figure 2C and Figure 5B A summary flowchart of the method for handling the second failure test that was discussed. (See reference) Figure 5D At step 552, it is determined whether the following conditions related to the second fault test are both true: the amplitude of the second current sensed by the current sensing circuit is lower than a specified current threshold; and the second voltage sensed by the voltage sensing circuit is higher than a specified voltage threshold. If the answer at step 552 is "yes," the process proceeds to step 554. At step 554, it is determined that at least one of the second pair of switches (e.g., switch Sa2 and switch Sb1) is stuck in the off state. Such information may be displayed or otherwise provided to physicians, technicians, or other users via a display, printout, or some other user interface.

[0095] If the answer to the determination at step 552 is "no", the process proceeds to step 556. At step 556, it is determined whether both of the following conditions related to the second fault test are true: the amplitude of the second current sensed by the current sensing circuit is below a specified current threshold; and the second voltage sensed by the voltage sensing circuit is below a specified voltage threshold. If the answer to the determination at step 556 is "yes", the process proceeds to step 558. At step 558, it is determined that at least one of the first pair of switches (e.g., switch Sa1 and switch Sb2) is stuck in the ON state. Such information may be displayed or otherwise provided to a physician, technician, or other user via a display, printout, or some other user interface. If the answer to the determination at step 556 is "no", the process proceeds to step 560, and the reason for the failure of the first fault test is uncertain. The order of steps 552 and 556 may be reversed.

[0096] Back Figure 5A and Figure 5B In another embodiment, it can be referenced Figure 5A The reference was executed before the described fault test. Figure 5B The described fault test. If this is the case, refer to... Figure 5B The described fault test can be referred to as the first fault test, and referenced Figure 5A The described fault test may be referred to as the second fault test. Other variations are also possible and are within the scope of the embodiments described herein.

[0097] Reference Figure 2B and Figure 2CIn the illustrated and described embodiments, switch Sp is shown as open (i.e., on) during the first and second fault tests, meaning that the HV power supply 202 remains decoupled from the HV capacitor 206 during both tests. In such an embodiment, the HV capacitor 206 should be charged before the first fault test and recharged between the first and second fault tests, in which case switch Sp should be on for a period of time and then off before and between the first and second fault tests. In an alternative embodiment, where switch Sp remains on (i.e. closed) during both the first and second fault tests, the voltage sensing circuit 226 will still be able to detect low-voltage conditions (i.e., when the voltage sensing circuit 226 senses a voltage below a specified voltage threshold) as long as the HV power supply 202 is designed to not provide sufficient power to keep the HV capacitor 206 charged (above a specified voltage threshold) if one of the switches Sa1, Sa2, Sb1, or Sb2 in the switching network fails (stuck in an off state or stuck in an on state). As an alternative or additional solution to using switch Sp to control whether the output of HV power supply device 202 is coupled to or decoupled from HV capacitor 206, the output of HV power supply device 202 can be selectively enabled and disabled. Accordingly, when the output of HV power supply device 202 can be selectively enabled and disabled by controller 204, switch Sp can be optionally omitted.

[0098] It should be understood that the subject matter described herein is not limited in its application to the details of the arrangement and structure of the components set forth in this specification or shown in the accompanying drawings. The subject matter described herein can be other embodiments and can be practiced or performed in a variety of ways. Furthermore, it should be understood that the wording and terminology used herein are for descriptive purposes and should not be considered limiting. The use of “comprising,” “including,” or “having,” and variations thereof herein is intended to cover the items listed thereafter and their equivalents and additional items. Moreover, it should be noted that, unless otherwise stated, the term “based on” as used herein should be interpreted as being based at least in part on the following meanings: one or more additional factors may exist to make the decision, etc. For example, if a decision is based on the results of a comparison, then in addition to being based on the results of the comparison, the decision may also be based on one or more other factors.

[0099] The embodiments of this technology have been described above using functional building blocks that illustrate the performance of specified functions and their relationships. For ease of description, the boundaries of these functional building blocks are frequently defined herein. Alternative boundaries can be defined as long as the specified functions and their relationships are properly performed. Therefore, any such alternative boundaries are within the scope and spirit of the claimed invention. For example, they can be combined or separated. Figures 5A to 5D The steps shown are some examples, and the order of the steps can be changed. For another example, the steps can be changed... Figures 1A to 2C The boundaries of some blocks are shown.

[0100] It should be understood that the above description is illustrative and not restrictive. For example, the above embodiments (and / or aspects thereof) can be used in combination with each other. Furthermore, various modifications can be made to adapt particular situations or materials to the teachings of embodiments of the invention without departing from the scope of the invention. Many other embodiments will be apparent to those skilled in the art after reading the above specification. Therefore, the scope of embodiments of the present technology should be determined by reference to the appended claims and the full scope of their authorized equivalents. In the appended claims, the terms “comprising” and “wherein” are used as common English equivalents of the corresponding terms “comprising” and “wherein”. Furthermore, in the appended claims, the terms “first,” “second,” and “third,” etc., are used only as denoting marks and are not intended to impose numerical requirements on their objects. In addition, the limitations of the following claims are not written in a means-plus-function format and are not intended to be interpreted based on 35 U.S.SC §112(f), unless and until such a claim is limited by the explicit use of the phrase “means for something,” followed by a functional statement without further structure.

Claims

1. A signal generator, comprising: One or more capacitors coupled between a high voltage rail and a low voltage rail and configured to store energy that can be used to selectively generate processed signals; A waveform shaping circuit coupled to the one or more capacitors and including a first switch, a second switch, a third switch, and a fourth switch, each of the switches being configured to selectively turn on and off, and each of the switches being configured to allow current to flow through the switch when the switch is on and to block current from flowing through the switch when the switch is off, wherein the first switch and the second switch are connected in series in a first branch of the waveform shaping circuit, the third switch and the fourth switch are connected in series in a second branch of the waveform shaping circuit, and the first branch and the second branch are connected in parallel with each other; A controller configured to selectively control the switches to selectively turn on a first pair of switches and turn off a second pair of switches during a first time period, and to selectively turn off the first pair of switches and turn on the second pair of switches during a second time period, in order to generate the processing signal, wherein the first pair of switches includes the first switch and the fourth switch, and the second pair of switches includes the second switch and the third switch; A voltage sensing circuit, configured to sense the voltage stored on the one or more capacitors; and A current sensing circuit configured to sense a current having an amplitude that characterizes the amplitude of the current flowing through a pair of switches turned on by the controller. The controller is also configured to: A first fault test is selectively performed on the signal generator, wherein during the first fault test, the first pair of switches is turned on, the second pair of switches is turned off, the voltage sensed by the voltage sensing circuit stored on the one or more capacitors is compared with a specified voltage threshold, and the current amplitude sensed by the current sensing circuit is compared with a specified current threshold. In response to the voltage stored in the one or more capacitors sensed by the voltage sensing circuit being lower than a specified voltage threshold and the current amplitude sensed by the current sensing circuit being higher than a specified current threshold, it is determined that the signal generator has passed the first fault test; and In response to the current amplitude sensed by the current sensing circuit being lower than the specified current threshold, it is determined that the signal generator has failed the first fault test.

2. The signal generator according to claim 1, wherein, As part of the first fault test, the controller is configured to: In response to the current amplitude sensed by the current sensing circuit being lower than the specified current threshold and the voltage sensed by the voltage sensing circuit being higher than the specified voltage threshold, it is determined that at least one of the first pair of switches is stuck in the open state. as well as In response to the current amplitude sensed by the current sensing circuit being lower than the specified current threshold and the voltage sensed by the voltage sensing circuit being lower than the specified voltage threshold, it is determined that at least one of the second pair of switches is stuck in the ON state.

3. The signal generator according to claim 1, wherein, The controller is further configured to: A second fault test is selectively performed on the signal generator, wherein during the second fault test, the first pair of switches is disconnected and the second pair of switches is turned on; and In response to a voltage sensed by the voltage sensing circuit being lower than the specified voltage threshold and a current amplitude sensed by the current sensing circuit being higher than the specified current threshold, it is determined that the signal generator has passed the second fault test; and In response to the current amplitude sensed by the current sensing circuit being lower than the specified current threshold, it is determined that the signal generator has failed the second fault test.

4. The signal generator according to claim 3, wherein, As part of the second fault test, the controller is configured to: In response to the current amplitude sensed by the current sensing circuit being lower than the specified current threshold and the voltage sensed by the voltage sensing circuit being higher than the specified voltage threshold, it is determined that at least one of the second pair of switches is stuck in the open state. as well as In response to the current amplitude sensed by the current sensing circuit being lower than the specified current threshold and the voltage sensed by the voltage sensing circuit being lower than the specified voltage threshold, it is determined that at least one of the first pair of switches is stuck in the ON state.

5. The signal generator according to claim 4, wherein, The controller is configured to perform at least one of the first fault test and the second fault test in response to power-on of the signal generator.

6. The signal generator according to any one of claims 1 to 5, wherein, The controller is implemented by at least one of a processor or a field-programmable gate array (FPGA).

7. The signal generator according to any one of claims 1 to 5, wherein: The first output node of the waveform shaping circuit is located between the first switch and the second switch; The second output node of the waveform shaping circuit is located between the third switch and the fourth switch.

8. The signal generator according to claim 7, wherein: The first switch is connected between the high voltage rail and the first output node; The second switch is connected between the first output node and the low voltage rail; The third switch is connected between the high-voltage rail and the second output node; as well as The fourth switch is connected between the second output node and the low voltage rail.

9. The signal generator according to claim 8, further comprising: A transformer, comprising a first primary winding, a second primary winding, and a secondary winding; The first primary winding and the second primary winding are connected in parallel and coupled between the first output node and the second output node of the waveform shaping circuit; and The current sensed by the current sensing circuit is generated in response to the voltage induced in the secondary winding, and the current is used to generate a processing signal applied to the patient's tissue.

10. The signal generator according to any one of claims 1 to 5, further comprising: A transformer, comprising a first primary winding, a second primary winding, and a secondary winding; The first primary winding and the second primary winding are connected in parallel and coupled to the waveform shaping circuit; and The current sensed by the current sensing circuit is generated in response to the voltage induced in the secondary winding, and the current is used to generate a processing signal applied to the patient's tissue.

11. A method used by a signal generator, the signal generator comprising: One or more capacitors configured to store energy that can be used to selectively generate processed signals; as well as A waveform shaping circuit coupled to the one or more capacitors and including a first switch, a second switch, a third switch, and a fourth switch, each of the switches being configured to selectively turn on and off, and each of the switches being configured to allow current to flow through the switch when the switch is on and to block current from flowing through the switch when the switch is off, wherein the first switch and the second switch are connected in series in a first branch of the waveform shaping circuit, the third switch and the fourth switch are connected in series in a second branch of the waveform shaping circuit, and the first branch and the second branch are connected in parallel with each other; The method includes: A first fault test is performed on the signal generator, wherein during the first fault test, a first pair of switches in the switch is turned on and a second pair of switches in the switch is turned off, wherein the first pair of switches includes the first switch and the fourth switch, and the second pair of switches includes the second switch and the third switch; As part of the first fault test, a first voltage stored on the one or more capacitors is sensed and the first voltage is compared with a specified voltage threshold. As part of the first fault test, a first current is sensed, the first current having an amplitude that characterizes the amplitude of the current flowing through the first pair of switches that have been turned on, and the amplitude of the first current is compared with a specified current threshold; and Based on a comparison of the first voltage stored on the one or more capacitors with the specified voltage threshold, and based on a comparison of the first current with the specified current threshold, it is determined whether the signal generator has passed the first fault test.

12. The method according to claim 11, wherein, Determining whether the signal generator passes the first fault test includes: In response to the first voltage being lower than a specified voltage threshold as part of the first fault test, and the amplitude of the first current being higher than a specified current threshold as part of the first fault test, it is determined that the signal generator has passed the first fault test.

13. The method according to claim 12, wherein, Determining whether the signal generator passes the first fault test includes: In response to the amplitude of the first current being lower than the specified current threshold, it is determined that the signal generator has failed the first fault test.

14. The method according to claim 13, wherein, Determining that the signal generator failed the first fault test further includes: In response to the first current amplitude sensed as part of the first fault test being lower than the specified current threshold, and the first voltage sensed as part of the first fault test being higher than the specified voltage threshold, it is determined that at least one switch in the first pair of switches is stuck in the open state; and In response to the first current amplitude being lower than the specified current threshold and the first voltage being lower than the specified voltage threshold as part of the first fault test, it is determined that at least one of the second pair of switches is stuck in the ON state.

15. The method of claim 14, wherein The first output node of the waveform shaping circuit is located between the first switch and the second switch; The second output node of the waveform shaping circuit is located between the third switch and the fourth switch.

16. The method according to any one of claims 11 to 15, further comprising: A second fault test is performed on the signal generator, wherein during the second fault test, the first pair of switches is disconnected and the second pair of switches is turned on; As part of the second fault test, a second voltage stored on the one or more capacitors is sensed; As part of the second fault test, a second current is sensed, the second current having an amplitude that characterizes the amplitude of the current flowing through the second pair of switches that have been turned on; and The signal generator passes the second fault test based on the second voltage stored on the one or more capacitors and based on the second current, wherein the second current has an amplitude that characterizes the amplitude of the current flowing through the second pair of switches that are turned on, and the second voltage and the second current are sensed as part of the second fault test.

17. The method according to claim 16, wherein, Determining whether the signal generator passes the second fault test includes: In response to the second voltage being lower than a specified voltage threshold as part of the second fault test, and the amplitude of the second current being higher than a specified current threshold as part of the second fault test, it is determined that the signal generator has passed the second fault test.

18. The method according to claim 17, wherein, Determining whether the signal generator passes the second fault test includes: In response to the second current amplitude being lower than the specified current threshold sensed as part of the second fault test, it is determined that the signal generator has failed the second fault test.

19. The method according to claim 18, wherein, Determining that the signal generator failed the second fault test further includes: In response to the second current amplitude sensed as part of the second fault test being lower than the specified current threshold, and the second voltage sensed as part of the second fault test being higher than the specified voltage threshold, it is determined that at least one of the second pair of switches is stuck in the open state; or In response to the second current amplitude being lower than the specified current threshold and the second voltage being lower than the specified voltage threshold as part of the second fault test, it is determined that at least one of the first pair of switches is stuck in the ON state.

20. A signal generator, comprising: One or more capacitors configured to store energy capable of selectively generating processed signals; A switching network comprising a first switch, a second switch, a third switch, and a fourth switch, wherein the first switch and the second switch are connected in series with each other and in parallel with the one or more capacitors, and the third switch and the fourth switch are connected in series with each other and in parallel with the one or more capacitors; Each of the first switch, the second switch, the third switch, and the fourth switch is configured to selectively turn on and off, to allow current to flow through the switch when the switch is on, and to block current from flowing through the switch when the switch is off; A controller configured to selectively control the switches to selectively turn on the first switch and the fourth switch and turn off the second switch and the third switch during a first time period, and to selectively turn off the first switch and the fourth switch and turn on the second switch and the third switch during a second time period, in order to generate the processing signal; A voltage sensing circuit configured to sense the voltage stored on the one or more capacitors; as well as A current sensing circuit configured to sense a current having an amplitude that characterizes the amplitude of the current flowing through a switch turned on by the controller. The controller is also configured to: A first fault test is selectively performed on the signal generator, wherein during the first fault test, the first switch and the fourth switch are turned on, the second switch and the third switch are turned off, the voltage sensed by the voltage sensing circuit stored on the one or more capacitors is compared with a specified voltage threshold, and the current amplitude sensed by the current sensing circuit is compared with a specified current threshold. In response to a voltage sensed by the voltage sensing circuit being lower than a specified voltage threshold and a current amplitude sensed by the current sensing circuit being higher than a specified current threshold, it is determined that the signal generator has passed the first fault test; and In response to the current amplitude stored in the one or more capacitors, sensed by the current sensing circuit, being lower than the specified current threshold, it is determined that the signal generator has failed the first fault test.

21. The signal generator according to claim 20, wherein, The controller is further configured to: A second fault test is selectively performed on the signal generator, wherein during the second fault test, the first switch and the fourth switch are disconnected, and the second switch and the third switch are turned on; and In response to the voltage sensed by the voltage sensing circuit being lower than the specified voltage threshold and the amplitude of the current sensed by the current sensing circuit being higher than the specified current threshold, it is determined that the signal generator has passed the second fault test; and In response to the current amplitude sensed by the current sensing circuit being lower than the specified current threshold, it is determined that the signal generator has failed the second fault test.

22. The signal generator according to claim 20 or 21, further comprising: The first output node between the first switch and the second switch; The second output node between the third switch and the fourth switch; A transformer, comprising a first primary winding, a second primary winding, and a secondary winding; The first primary winding and the second primary winding are connected in parallel and coupled between the first output node and the second output node; and The current sensed by the current sensing circuit is generated in response to the voltage induced in the secondary winding, and the current is used to generate a processing signal applied to the patient's tissue.

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