# Patent

## Title
Square wave for vessel sealing

## Abstract

A square wave generator suitable for use with an electrosurgical device is provided. The square wave generator includes a voltage source configured to output a waveform and a comparator operatively coupled to the voltage source and configured to output energy in the form of a square wave. The generator may also include at least one sensor configured to sense an operational parameter of the energy outputted from the comparator and to provide a sensor signal corresponding thereto and a controller adapted to receive the at least one sensor signal and in response thereto control the voltage source.

## Background
BACKGROUND
1. Technical Field
The present disclosure relates to systems for providing energy to biological tissue and, more particularly, to an apparatus that utilizes square waves to deliver energy to biological tissue.
2. Background of the Related Art
Energy-based tissue treatment is well known in the art. Various types of energy (e.g., electrical, ultrasonic, microwave, cryogenic, thermal, laser, etc.) are applied to tissue to achieve a desired result. Electrosurgery involves application of high radio frequency electrical current to a surgical site to cut, ablate, coagulate or seal tissue. In monopolar electrosurgery, a source or active electrode delivers radio frequency energy from the electrosurgical generator to the tissue and a return electrode carries the current back to the generator. In monopolar electrosurgery, the source electrode is typically part of the surgical instrument held by the surgeon and applied to the tissue to be treated. A patient return electrode is placed remotely from the active electrode to carry the current back to the generator.
Ablation is most commonly a monopolar procedure that is particularly useful in the field of cancer treatment, where one or more RF ablation needle electrodes (usually having elongated cylindrical geometry) are inserted into a living body and placed in the tumor region of an affected organ. A typical form of such needle electrodes incorporates an insulated sheath from which an exposed (uninsulated) tip extends. When RF energy is provided between the return electrode and the inserted ablation electrode, RF current flows from the needle electrode through the body. Typically, the current density is very high near the tip of the needle electrode, which tends to heat and destroy surrounding issue.
In bipolar electrosurgery, one of the electrodes of the hand-held instrument functions as the active electrode and the other as the return electrode. The return electrode is placed in close proximity to the active electrode such that an electrical circuit is formed between the two electrodes (e.g., electrosurgical forceps). In this manner, the applied electrical current is limited to the body tissue positioned immediately adjacent the electrodes. When the electrodes are sufficiently separated from one another, the electrical circuit is open and thus inadvertent contact with body tissue with either of the separated electrodes does not cause current to flow.
Typically, sinusoidal waveforms are used to deliver energy for a desired tissue effect in electrosurgical and vessel sealing applications. Creating sinusoidal waveforms requires the use of low harmonic content linear drive or resonant switching amplifier topologies. However, linear drive electronics, which use linear components such as resistors, capacitors and inductors, tend to be inefficient due to the power loss caused by such linear components. With regard to resonant amplifier topologies, such topologies require large resonant components to shape the output waveform.
Further, in order to achieve excellent tissue sealing performance, it is important to monitor the impedance of the tissue to which energy is being applied. The impedance is calculated by measuring the root mean square (RMS) voltage and current of the radio frequency (RF) energy output to calculate the tissue impedance. However, with sinusoidal waveforms, complicated sensing hardware and/or signal processing is required to accurately calculate RMS voltage and/or current. Further, sinusoidal waveforms tend to have a peak voltage that 1.414 times the RMS voltage of the waveform. The higher peak voltage may have a negative impact on certain tissue treatments.
SUMMARY
The present disclosure provides a square wave generator suitable for use with an electrosurgical device in an embodiment of the present disclosure. The square wave generator includes a voltage source configured to output a waveform and a comparator operatively coupled to the voltage source and configured to output energy in the form of a square wave. The generator may also include at least one sensor configured to sense an operational parameter of the energy outputted from the comparator and to provide a sensor signal corresponding thereto, and a controller adapted to receive the at least one sensor signal and in response thereto control the voltage source.
The square wave generator may also include a positive high voltage direct current source coupled to the comparator and a negative high voltage direct current source coupled to the comparator. The controller may control the output of the positive high voltage direct current source and the negative high voltage direct current source in response to the at least one sensor signal to control the output of the square wave generator.
The operational parameter sensed by the circuit may be peak voltage or current.
In another embodiment of the present disclosure, a square wave generator suitable for use with an electrosurgical device is provided. The square wave generator includes a waveform synthesizer configured to output a waveform and an amplifier operatively coupled to the waveform synthesizer and configured to output energy in the form of a square wave. The generator may also include at least one sensor configured to sense an operational parameter of the energy outputted from the comparator and to provide a sensor signal corresponding thereto, and a controller adapted to receive the at least one sensor signal and in response thereto control the voltage source.
The square wave generator may also include a positive high voltage direct current source coupled to the comparator and a negative high voltage direct current source coupled to the comparator. The controller may control the output of the positive high voltage direct current source and the negative high voltage direct current source in response to the at least one sensor signal to control the output of the square wave generator.
The operational parameter sensed by the circuit may be peak voltage or current.
The amplifier may include at least two gain elements arranged in a push-pull configuration. The at least two gain elements are selected from the group consisting of bipolar transistors, field-effect transistors, and laterally diffused metal oxide semiconductors.
The square wave generator may also have a gain stage coupled between the waveform synthesizer and the amplifier. The gain stage may include a transformer.



BRIEF DESCRIPTION OF THE DRAWINGS
The above and other aspects, features, and advantages of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings in which:
FIGS. 1A-1B are schematic block diagrams of an electrosurgical system according to the present disclosure for use with various instrument types;
FIG. 2 is a schematic block diagram of a generator according to an embodiment of the present disclosure;
FIG. 3 is a schematic diagram of a generator according to another embodiment of the present disclosure;
FIG. 4 is a schematic diagram of a generator according to another embodiment of the present disclosure;
FIG. 5 is a schematic diagram of a generator according to another embodiment of the present disclosure; and
FIG. 6 is a schematic diagram of a generator according to another embodiment of the present disclosure.



DETAILED DESCRIPTION
Particular embodiments of the present disclosure are described hereinbelow with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are merely exemplary of the disclosure, which may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure. Like reference numerals may refer to similar or identical elements throughout the description of the figures.
The generator according to the present disclosure can perform ablation, monopolar and bipolar electrosurgical procedures, including vessel sealing procedures. The generator may include a plurality of outputs for interfacing with various electrosurgical instruments (e.g., a monopolar active electrode, return electrode, bipolar electrosurgical forceps, footswitch, etc.). Further, the generator includes electronic circuitry configured for generating radio frequency power specifically suited for various electrosurgical modes (e.g., cutting, blending, division, etc.) and procedures (e.g., monopolar, bipolar, vessel sealing).
FIG. 1A is a schematic illustration of a monopolar electrosurgical system 1 according to one embodiment of the present disclosure. The system 1 includes an electrosurgical instrument 2 having one or more electrodes for treating tissue of a patient P. The instrument 2 is a monopolar type instrument including one or more active electrodes (e.g., electrosurgical cutting probe, ablation electrode(s), etc.). Electrosurgical RF energy is supplied to the instrument 2 by a generator 20 via a supply line 4, which is connected to an active terminal (FIG. 2) of the generator 20, allowing the instrument 2 to coagulate, ablate and/or otherwise treat tissue. The energy is returned to the generator 20 through a return electrode 6 via a return line 8 at a return terminal (FIG. 2) of the generator 20. The active terminal and the return terminal are connectors configured to interface with plugs (not explicitly shown) of the instrument 2 and the return electrode 6, which are disposed at the ends of the supply line 4 and the return line 8, respectively.
The system 1 may include a plurality of return electrodes 6 that are arranged to minimize the chances of tissue damage by maximizing the overall contact area with the patient P. In addition, the generator 20 and the return electrode 6 may be configured for monitoring so-called “tissue-to-patient” contact to insure that sufficient contact exists therebetween to further minimize chances of tissue damage. In one embodiment, the active electrode 6 may be used to operate in a liquid environment, wherein the tissue is submerged in an electrolyte solution.
The generator 20 includes suitable input controls (e.g., buttons, activators, switches, touch screen, etc.) for controlling the generator 20. In addition, the generator 20 may include one or more display screens for providing the user with variety of output information (e.g., intensity settings, treatment complete indicators, etc.). The controls allow the user to adjust power of the RF energy, waveform, as well as the level of maximum arc energy allowed which varies depending on desired tissue effects and other parameters to achieve the desired waveform suitable for a particular task (e.g., coagulating, tissue sealing, intensity setting, etc.). The instrument 2 may also include a plurality of input controls that may be redundant with certain input controls of the generator 20. Placing the input controls at the instrument 2 allows for easier and faster modification of RF energy parameters during the surgical procedure without requiring interaction with the generator 20.
FIG. 1B is a schematic illustration of a bipolar electrosurgical system 3 according to the present disclosure. The system 3 includes a bipolar electrosurgical forceps 10 having one or more electrodes for treating tissue of a patient P. The electrosurgical forceps 10 include opposing jaw members having an active electrode 14 and a return electrode 16, respectively, disposed therein. The active electrode 14 and the return electrode 16 are connected to the generator 20 through cable 18, which includes the supply and return lines 4, 8 coupled to the active and return terminals 112 and 114, respectively. The electrosurgical forceps 10 are coupled to the generator 20 at a connector 21 having connections to the active and return terminals (e.g., pins) via a plug disposed at the end of the cable 18, wherein the plug includes contacts from the supply and return lines 4, 8.
FIG. 2 is a schematic block diagram of the generator 20 shown in FIG. 1 for use with an electrosurgical system according to an embodiment of the present disclosure. As shown in FIG. 2, generator 20 includes a square wave generator 100, active terminal 112, return terminal 114, sensor 122 and controller 124. Square wave generator 100 is operatively coupled to active terminal 112 to provide electrosurgical energy in the form of a square wave to an electrosurgical instrument. In particular, the active terminal 112 generates either continuous or pulsed square waveforms of high RF energy. The active terminal 112 is configured to generate a plurality of waveforms having various duty cycles, peak voltages, crest factors, and other suitable parameters. Certain types of waveforms are suitable for specific electrosurgical modes. For instance, the active terminal 112 generates a 100% duty cycle sinusoidal waveform in cut mode, which is best suited for ablating, fusing and dissecting tissue and a 1-25% duty cycle waveform in coagulation mode, which is best used for cauterizing tissue to stop bleeding.
The generator 20 may implement a closed and/or open loop control schemes that include a sensor circuit 122 having a plurality of sensors measuring a variety of tissue and energy properties (e.g., tissue impedance, tissue temperature, output current and/or voltage, etc.), and providing feedback to the controller 124. A current sensor can be disposed at either the active or return current path or both and voltage can be sensed at the active electrode(s). The controller 124 then transmits appropriate signals to the square wave generator 100, which then adjusts AC or DC power supply, respectively, by using a maximum allowable energy that varies according to the selected mode. The controller 124 also receives input signals from the input controls of the generator 20 or the instrument 2. The controller 124 utilizes the input signals to adjust power output by the generator 20 and/or performs other control functions thereon.
When electrosurgical energy is applied to tissue, the impedance of the tissue changes. The sensor circuit 122 measures the electrical current (I) and voltage (V) supplied by the active terminal 112 in real time to characterize the electrosurgical process during application of electrosurgical energy to tissue. This allows for the measured electrical properties to be used as dynamic input control variables to achieve feedback control. The current and voltage values may also be used to derive other electrical parameters, such as power (P=V*I) and impedance (Z=V/I). The sensor circuit 122 also measures properties of the current and voltage waveforms and determines the shape thereof.
The controller 124 includes a microprocessor operably connected to a memory, which may be volatile type memory (e.g., RAM) and/or non-volatile type memory (e.g., flash media, disk media, etc.). The controller 124 includes an output port that is operably connected to the square wave generator 100 allowing the controller 124 to control the output of the generator 20 according to either open and/or closed control loop schemes. Those skilled in the art will appreciate that the microprocessor may be substituted by any logic processor or analog circuitry (e.g., control circuit) adapted to perform the calculations discussed herein.
Because the output of generator 20 is a square wave, the RMS voltage and current is equal to the peak value of the square wave. As such, generator 20 does not need complicated sense hardware and/or signal processing that is usually required to accurately calculate RMS voltage and/or current for sinusoidal waveforms. Therefore, generator 20 has fewer components than the typical electrosurgical generator. Further, because the output of generator 20 is a square wave, generator 20 does not need large resonant components to shape the square wave.
Additionally, square wave generators are more efficient and can be made smaller than the typical electrosurgical generator in both the amplifier and sensor sections. Accordingly, a generator according to the above described embodiment may be incorporated into a portable handheld surgical device capable of being powered by a battery, battery pack or other portable power supply.
FIG. 3 is a schematic illustration of a generator 30 for use with an electrosurgical system according to another embodiment of the present disclosure. As shown in FIG. 3, generator 30 has a voltage source 102 that generates an output voltage that is transmitted to comparator 104. The output voltage may be in the form of a sine wave, saw tooth wave or square wave. The output voltage is compared to a reference voltage at the negative input of comparator 104. Although FIG. 3 shows the reference voltage as ground any other voltage may be used as a reference voltage.
Comparator 104 is supplied with a positive high voltage direct current (+HVDC) source 132 and a negative high voltage direct current (−HVDC) source 134. As such, when the output voltage from voltage source 102 is positive, the output of comparator 104 is +HVDC and when the output voltage from voltage source 102 is negative, the output of comparator 104 is −HVDC. The comparator output is coupled to the active terminal 112 and provides energy in the form of a square wave to the electrosurgical instrument.
Generator 30 may implement a closed and/or open loop control schemes that include a sensor circuit 122 having a plurality of sensors measuring a variety of tissue and energy properties (e.g., tissue impedance, tissue temperature, output current and/or voltage, etc.), and providing feedback to the controller 124. A current sensor can be disposed at either the active or return current path or both and voltage can be sensed at the active electrode(s). The controller 124 then transmits appropriate signals to the voltage source 102, +HVDC source 132 and/or −HVDC source 134, which then adjusts AC or DC power supply, respectively, by using a maximum allowable energy that varies according to the selected mode. The controller 124 also receives input signals from the input controls of the generator 20 or the instrument 2. The controller 124 utilizes the input signals to adjust power output by the generator 20 and/or performs other control functions thereon.
FIG. 4 is a schematic illustration of a generator 40 according to another embodiment of the present disclosure. As shown in FIG. 4, generator 40 includes a waveform synthesizer 302 that generates waveforms having various duty cycles, peak voltages, crest factors, and other suitable parameters based on a selected mode for the electrosurgical device. Waveform synthesizer 302 may include a pulse width modulated (PWM) controller that generates a PWM signal.
The output of waveform synthesizer 302 is fed into voltage gain stage 303. Voltage gain stage 303 amplifies the input voltage and provides the amplified voltage as an output to a class A/B amplifier 308. Voltage gain stage 303 may include a transformer to provide patient isolation between the waveform synthesizer 302 and the patient. Voltage gain stage 303 may also include a bias circuit that can be controlled by controller 124 to provide a bias voltage for the class A/B amplifier 308. The combined power amplifier formed by 303 and 308 may be run open-loop or closed-loop.
Amplifier 308 may include two transistors in a push-pull configuration and may be a part of the voltage gain stage 303 or be discrete components. The two transistors in amplifier 308 may be bipolar transistors, field-effect transistors or laterally diffused metal oxide semiconductors. When a positive voltage is applied to the base of Q1, a high positive voltage from +HVDC source 132 is supplied to the active terminal 112. When a negative voltage is applied to the base of Q2, a high negative voltage from −HVDC source 134 is supplied to active terminal 112.
Generator 40 also includes a sensor circuit 122 that measures the electrical current (I) and voltage (V) supplied by the active terminal 112 in real time to characterize the electrosurgical process for a predetermined sampling period. Sensor circuit 122 provides a feedback signal to controller 124. Controller 124 analyzes the feedback signal and controls the output of the waveform synthesizer 302, +HVDC source 132 and −HVDC source 132 based on the feedback signal.
FIG. 5 is a schematic illustration of a generator 50 according to another embodiment of the present disclosure. As shown in FIG. 5, generator 50 includes switching amplifier 504 in a push-pull configuration that generates waveforms having various duty cycles, peak voltages, crest factors, and other suitable parameters based on a selected mode for the electrosurgical device. Switching amplifier 504 may include two transistors in a push-pull configuration. The two transistors in switching amplifier 504 may be bipolar transistors, field-effect transistors or laterally diffused metal oxide semiconductors. The output of switching amplifier 504 is fed into transformer 502. Transformer 502 receives the input voltage and provides an output voltage to active terminal 112.
Generator 50 also includes a sensor circuit 122 that measures the electrical current (I) and voltage (V) supplied by the active terminal 112 in real time to characterize the electrosurgical process for a predetermined sampling period. Sensor circuit 122 provides a feedback signal to controller 124. Controller 124 analyzes the feedback signal and controls the output of the switching amplifier 504 based on the feedback signal.
FIG. 6 is a schematic illustration of a generator 60 according to another embodiment of the present disclosure. As shown in FIG. 6, generator 60 includes switching amplifier 604 in a full-bridge configuration that generates waveforms having various duty cycles, peak voltages, crest factors, and other suitable parameters based on a selected mode for the electrosurgical device. Switching amplifier 604 may include four transistors that may be bipolar transistors, field-effect transistors or laterally diffused metal oxide semiconductors. The output of switching amplifier 604 is fed into transformer 602. Transformer 602 receives the input voltage and provides an output voltage to active terminal 112.
Generator 60 also includes a sensor circuit 122 that measures the electrical current (I) and voltage (V) supplied by the active terminal 112 in real time to characterize the electrosurgical process for a predetermined sampling period. Sensor circuit 122 provides a feedback signal to controller 124. Controller 124 analyzes the feedback signal and controls the output of the switching amplifier 604 based on the feedback signal.
The generators described above with regard to FIGS. 2-6 include suitable input controls (e.g., buttons, activators, switches, touch screen, etc.) for controlling the generator. In addition, the generator may include one or more display screens for providing the user with variety of output information (e.g., intensity settings, treatment complete indicators, etc.). The controls allow the user to adjust power of the RF energy, waveform, as well as the level of maximum arc energy allowed which varies depending on desired tissue effects and other parameters to achieve the desired waveform suitable for a particular task (e.g., coagulating, tissue sealing, intensity setting, etc.). The instrument 2 may also include a plurality of input controls that may be redundant with certain input controls of the generator. Placing the input controls at the instrument 2 allows for easier and faster modification of RF energy parameters during the surgical procedure without requiring interaction with the generator.
The generator may include a plurality of connectors to accommodate various types of electrosurgical instruments (e.g., instrument 2, electrosurgical forceps 10, etc.). Further, the generator may operate in monopolar or bipolar modes by including a switching mechanism (e.g., relays) to switch the supply of RF energy between the connectors, such that, for instance, when the instrument 2 is connected to the generator, only the monopolar plug receives RF energy.
Using square waves for treating tissue has many advantages over using sinusoidal waves. Square waves generators do not require additional resonant components to shape the waveform. Accordingly, a generator using a square wave output topology has a smaller implementation and a smaller component count than a generator that outputs a sinusoidal wave. Further, when using sinusoidal waves, complicated sensing hardware and/or signal processing may be required to calculate the RMS voltage and/or current. For example, to calculate the RMS voltage of a sinusoidal wave, multiple samples of the voltage waveform have to be measured and then applied to complicated digital signal processing algorithms to obtain the RMS voltage value. On the other hand, with a square wave output, a single sample may be used to obtain the RMS voltage value because the peak voltage value is equal to RMS voltage in a square wave. The simplified sensing method associated with square wave outputs reduces algorithm complexity thereby reducing required processor power and hardware costs.
Another consideration in certain tissue treatments using electrosurgical methods has to do with arcing between instrument jaws. Arcing may be caused by high peak voltage and tends to have a negative impact on electrosurgical performance. Sinusoidal waveforms have a higher peak voltage compared to square waves with the same RMS value. For example, consider a waveform having a 100V RMS value. For a square wave output, the peak voltage would equal the RMS voltage so the peak value would be 100V. However, for a pure sinusoidal waveform, the peak voltage is equal to 1.414 times the RMS value so the peak voltage would be 141.4V. This discrepancy increases with the crest factor of the sinusoidal waveform, Accordingly, the lower peak voltage of the square wave output reduces the risk of arcing and improves performance of the electrosurgical device.
While several embodiments of the disclosure have been shown in the drawings and/or discussed herein, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise, Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. The claims can encompass embodiments in hardware, software, or a combination thereof. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

## Claims

1. A square wave generator suitable for use with an electrosurgical device, the square wave generator comprising:
a waveform synthesizer configured to generate a waveform;
an amplifier operatively coupled to the waveform synthesizer for providing electrosurgical energy in a shape of square waves directly to tissue;
at least one sensor configured to sense an operational parameter of the electrosurgical energy outputted from the amplifier and to provide a sensor signal corresponding thereto; and
a controller adapted to receive the sensor signal and in response thereto control the waveform synthesizer.

2. The square wave generator according to claim 1, further comprising:
a positive high voltage direct current source coupled to the amplifier; and
a negative high voltage direct current source coupled to the amplifier,
wherein the controller controls the output of the positive high voltage direct current source and the negative high voltage direct current source in response to the at least one sensor signal to control the output of the square wave generator.

3. The square wave generator according to claim 1, wherein the operational parameter is peak voltage.

4. The square wave generator according to claim 1, wherein the operational parameter is current.

5. The square wave generator according to claim 1, wherein the amplifier comprises at least two gain elements arranged in a push-pull configuration.

6. The square wave generator according to claim 5, wherein the at least two gain elements are selected from the group consisting of bipolar transistors, field-effect transistors, and laterally diffused metal oxide semiconductors.

7. The square wave generator according to claim 1 further comprising a gain stage coupled between the waveform synthesizer and the amplifier.

8. The square wave generator according to claim 7, wherein the gain stage further comprises a transformer.

9. The square wave generator according to claim 7, wherein the gain stage is configured to amplify the waveform from the waveform synthesizer and output the amplified waveform to the amplifier.