Patent Application
20210361340
The present disclosure relates to systems and methods for controlling an electrosurgical generator. In particular, the present disclosure relates to controlling a plurality of electrosurgical devices that each delivers a separate monopolar and/or bipolar radio frequency waveform.
Electrosurgery involves application of high radio frequency electrical current to a surgical site to cut, ablate, desiccate, or coagulate tissue. In monopolar electrosurgery, a source or active electrode delivers radio frequency alternating current from the electrosurgical generator to the targeted tissue. A patient return electrode is placed remotely from the active electrode to conduct the current back to the generator.
In bipolar electrosurgery, return and active electrodes are placed in close proximity to each other such that an electrical circuit is formed between the two electrodes (e.g., in the case of an electrosurgical forceps). In this manner, the applied electrical current is limited to the body tissue positioned between the electrodes. Accordingly, bipolar electrosurgery generally involves the use of instruments where it is desired to achieve a focused delivery of electrosurgical energy between two electrodes.
The current solution for dual site surgery, namely, using two electrosurgical instruments simultaneously, is generally to use two electrosurgical generators. This solution is inherently cumbersome and cost prohibitive. Thus, there is a need for independent control of the multiple ports of a single electrosurgical generator capable of outputting simultaneous RF waveforms.
The present disclosure provides an electrosurgical system including an electrosurgical generator having two radio frequency (RF) channels generated by two separate RF sources. Each of the sources includes a power supply configured to output DC power and an RF power inverter configured to output an RF waveform. The individual RF waveform is supplied to a corresponding electrosurgical instrument, which may be monopolar or bipolar. Each of the sources is controlled by its own controller, each of which is coupled to a common clock source. The electrosurgical generator performs a wide band measurement of each source's discontinuous or continuous signal simultaneously detecting cross-conductance and cross-talk between the RF sources. As used herein, cross-conductance is an energy channel's current flowing through the opposite channel's contact impedance and cross-talk is radiated interference between energy channels inside the electrosurgical generator.
According to one embodiment of the present disclosure, an electrosurgical generator is disclosed. The electrosurgical generator includes a first radio frequency source having: a first power supply configured to output a first direct current waveform; a first radio frequency inverter coupled to the first power supply and configured to generate a monopolar radio frequency waveform from the first direct current waveform; and a first controller configured to control the first radio frequency inverter to output the monopolar radio frequency waveform. The generator also includes a second radio frequency source having: a second power supply configured to output a second direct current waveform; a second radio frequency inverter coupled to the second power supply and configured to generate a bipolar radio frequency waveform simultaneously as the monopolar radio frequency waveform; and a second controller configured to control the second radio frequency inverter to output the bipolar radio frequency waveform.
According to one aspect of the above embodiment, the generator further includes a clock source coupled to the first controller and the second controller and configured to synchronize sampling operation of the first controller and the second controller. The monopolar radio frequency waveform has a first frequency and the bipolar radio frequency waveform has a second frequency different from the first frequency. The first controller and the second controller are configured to perform frequency domain analysis of the monopolar radio frequency waveform and the bipolar radio frequency waveform, respectively. Each of the first controller and the second controller is further configured to detect cross-conductance between the first radio frequency source and the second radio frequency source based on the frequency domain analysis. Each of the first controller and the second controller is further configured to at least one of output an alarm or shut off both the first radio frequency source and the second radio frequency source in response to detection of the cross-conductance.
According to another aspect of the above embodiment, the first radio frequency source further includes a first active terminal coupled to the first radio frequency inverter and further configured to couple to a monopolar electrosurgical instrument. The second radio frequency source further includes a second active terminal and a second return terminal coupled to the second radio frequency inverter and further configured to couple to a bipolar electrosurgical instrument. The first radio frequency source further includes a first return terminal configured to couple to at least one return electrode pad, the first return terminal coupled to the first radio frequency inverter and the second radio frequency inverter. The first radio frequency source further includes a first isolation transformer having a primary winding coupled to the first radio frequency inverter and a secondary winding coupled to the first active terminal and the return terminal. The second radio frequency source further includes a second isolation transformer having a primary winding coupled to the second radio frequency inverter and a secondary winding coupled to the second active terminal and the second return terminal.
According to another embodiment of the present disclosure, an electrosurgical system is disclosed. The system includes: a monopolar electrosurgical instrument; a bipolar electrosurgical instrument; and an electrosurgical generator. The generator includes a first radio frequency source having a first power supply configured to output a first direct current waveform, and a first radio frequency inverter coupled to the first power supply and the monopolar electrosurgical instrument. The first radio frequency inverter is configured to supply a monopolar radio frequency waveform having a first frequency from the first direct current waveform to the monopolar electrosurgical instrument. The first radio frequency source also includes a first controller configured to control the first radio frequency inverter. The generator also includes a second radio frequency source having a second power supply configured to output a second direct current waveform and a second radio frequency inverter coupled to the second power supply and the bipolar electrosurgical instrument. The second radio frequency inverter is configured to generate a bipolar radio frequency waveform from the second direct current waveform to the bipolar electrosurgical instrument simultaneously as the monopolar radio frequency waveform. The second radio frequency source also includes a second controller configured to control the second radio frequency inverter.
According to one aspect of the above embodiment, the electrosurgical generator further includes a clock source coupled to the first controller and the second controller and is configured to synchronize sampling operation of the first controller and the second controller. The monopolar radio frequency waveform has a first frequency and the bipolar radio frequency waveform has a second frequency different from the first frequency. The first controller and the second controller are configured to perform frequency domain analysis of the monopolar radio frequency waveform and the bipolar radio frequency waveform, respectively. Each of the first controller and the second controller is further configured to detect cross-conductance between the first radio frequency source and the second radio frequency source based on the frequency domain analysis. Each of the first controller and the second controller is further configured to at least one of output an alarm or shut off both the first radio frequency source and the second radio frequency source in response to detection of the cross-conductance.
According to another aspect of the above embodiment, the first radio frequency source further includes a first active terminal coupled to the first radio frequency inverter and is further configured to couple to a monopolar electrosurgical instrument. The second radio frequency source further includes a second active terminal coupled to the second radio frequency inverter and further configured to couple to a bipolar electrosurgical instrument. The electrosurgical system further includes at least one return electrode pad, wherein the electrosurgical generator further includes a first return terminal coupled to the at least one return electrode pad and to the first radio frequency inverter and the second radio frequency inverter. The first radio frequency source further includes a first isolation transformer having a primary winding coupled to the first radio frequency inverter and a secondary winding coupled to the first active terminal and the first return terminal. The second radio frequency source further includes a second isolation transformer having a primary winding coupled to the second radio frequency inverter and a secondary winding coupled to the second active terminal and the second return terminal.
The present disclosure may be understood by reference to the accompanying drawings, when considered in conjunction with the subsequent, detailed description, in which:
Embodiments of the presently disclosed electrosurgical system are described in detail with reference to the drawings, in which like reference numerals designate identical or corresponding elements in each of the several views. As used herein the term “distal” refers to the portion of the surgical instrument coupled thereto that is closer to the patient, while the term “proximal” refers to the portion that is farther from the patient.
The term “application” may include a computer program designed to perform functions, tasks, or activities for the benefit of a user. Application may refer to, for example, software running locally or remotely, as a standalone program or in a web browser, or other software which would be understood by one skilled in the art to be an application. An application may run on a controller, or on a user device, including, for example, a mobile device, an IOT device, a server system, or any programmable logic device.
In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Those skilled in the art will understand that the present disclosure may be adapted for use with either an endoscopic instrument, a laparoscopic instrument, or an open instrument. It should also be appreciated that different electrical and mechanical connections and other considerations may apply to each particular type of instrument.
An electrosurgical generator according to the present disclosure may be used in monopolar and/or bipolar electrosurgical procedures, including, for example, cutting, coagulation, ablation, and vessel sealing procedures. The generator may include a plurality of outputs for interfacing with various ultrasonic and electrosurgical instruments (e.g., ultrasonic dissectors and hemostats, monopolar instruments, return electrode pads, bipolar electrosurgical forceps, footswitches, etc.). Further, the generator may include electronic circuitry configured to generate radio frequency energy specifically suited for powering ultrasonic instruments and electrosurgical devices operating in various electrosurgical modes (e.g., cut, blend, coagulate, division with hemostasis, fulgurate, spray, etc.) and procedures (e.g., monopolar, bipolar, vessel sealing).
Referring to
Bipolar electrosurgical instruments 30′ and 30′ are shown as tweezers having a pair of electrodes 33a′ and 33b′ and 33a″ and 33b″, respectively, for treating tissue of a patient. In embodiments, the bipolar electrosurgical instruments 30′ and 30″ may be a pair of forceps. The instruments 30′ and 30″ are coupled to a generator 100 via cables 34′ and 34″. The generator 100 is a dual source RF generator configured to supply a separate RF waveform to each of the instruments 30′ and 30″ from individual RF sources.
With reference to
The generator 100 is configured to operate in a variety of modes and is configured to output monopolar and/or bipolar waveforms based on the selected mode for each of the ports 110, 112, 114, 116. Each of the modes operates based on a preprogrammed power curve that dictates how much power is output by the generator 100 at varying impedance ranges of the load (e.g., tissue). Each of the power curves includes power, voltage and current control ranges that are defined by the user-selected intensity setting and the measured minimum impedance of the load.
The generator 100 may operate in the following monopolar modes, which include, but are not limited to, cut, blend, division with hemostasis, fulgurate and spray. The generator 100 may operate in the following bipolar modes, including bipolar coagulation, automatic bipolar which operates in response to sensing tissue contact, and various algorithm-controlled vessel sealing modes.
Each of the first and second RF waveforms may be either monopolar or bipolar RF waveforms, each of which may be continuous or discontinuous and may have a carrier frequency from about 200 kHz to about 500 kHz. As used herein, continuous waveforms are waveforms that have a 100% duty cycle. In embodiments, continuous waveforms are used to impart a cutting effect on tissue. Conversely, discontinuous waveforms are waveforms that have a non-continuous duty cycle, e.g., below 100%. In embodiments, discontinuous waveforms are used to provide coagulation effects to tissue.
In the cut mode, the generator 100 may supply a continuous sine waveform at a predetermined carrier frequency (e.g., 472 kHz) having a crest factor of about 1.5 with an impedance of from about 100Ω to about 2,000Ω. The cut mode power curve may include three regions: constant current into low impedance, constant power into medium impedance and constant voltage into high impedance. In the blend mode, the generator may supply bursts of a sine waveform at the predetermined frequency, with the bursts reoccurring at a first predetermined rate (e.g., about 26.21 kHz). In one embodiment, the duty cycle of the bursts may be about 50%. The crest factor of one period of the sine waveform may be about 1.5. The crest factor of the burst may be about 2.7.
The division with hemostasis mode may include bursts of sine waveforms at a predetermined frequency (e.g., 472 kHz) reoccurring at a second predetermined rate (e.g., about 28.3 kHz). The duty cycle of the bursts may be about 25%. The crest factor of one burst may be about 4.3 across an impedance of from about 100Ω to about 2,000Ω. The fulgurate mode may include bursts of sine waveforms at a predetermined frequency (e.g., 472 kHz) reoccurring at a third predetermined rate (e.g., about 30.66 kHz). The duty cycle of the bursts may be about 6.5% and the crest factor of one burst cycle may be about 5.55 across an impedance range of from about 100Ω to about 2,000Ω. The spray mode may include bursts of sine waveform at a predetermined frequency (e.g., 472 kHz) reoccurring at a fourth predetermined rate (e.g., about 21.7 kHz). The duty cycle of the bursts may be about 4.6% and the crest factor of one burst cycle may be about 6.6 across the impedance range of from about 100Ω to about 2,000Ω.
With reference to
The system 10 is shown in various configurations, with the generator 100 operating with any combination of monopolar and bipolar electrosurgical instruments 20′, 20″, 30′, and 30″. The generator 100 includes a dual source RF architecture, where each RF source is supplied by an individual and separate RF inverter, each of which is powered by an individual and separate DC power supply. More specifically, the generator 100 includes a first RF source 202 and a second source 302. The first RF source 202 energizes the ports 110 and 114 and the second RF source 302 energizes the ports 112 and 116. The port 118 is shared between the first RF source 202 and the second RF source 302.
Each of the sources 202 and 302 includes a first controller 204 and a second controller 304, a first power supply 206 and a second power supply 306, and a first RF inverter 208 and a second RF inverter 308. The power supplies 206 and 306 may be high voltage, DC power supplies connected to a common AC source (e.g., line voltage) and provide high voltage, DC power to their respective RF inverters 208 and 308, which then convert DC power into a first and second RF waveforms through their respective active terminals 210 and 310. RF energy is returned thereto via a first return terminal 212 and a second return terminal 312, respectively.
The active terminal 210 and the return terminal 212 are coupled to the RF inverter 208 through an isolation transformer 214. The isolation transformer 214 includes a primary winding 214a coupled to the RF inverter 208 and a secondary winding 214b coupled to the active and return terminals 210 and 212. Similarly, the active terminal 310 and the return terminal 312 are coupled to the RF inverter 308 through an isolation transformer 314. The isolation transformer 314 includes a primary winding 314a coupled to the RF inverter 308 and a secondary winding 314b coupled to the active and return terminals 310 and 312.
With reference to
With reference to
The generator 100 may include a plurality of steering relays or other switching devices configured to couple the active terminals 210 and 310 and the return terminals 212 and 312 to various ports 110, 112, 114, 116, 118 based on the combination of the monopolar and bipolar electrosurgical instruments 20′, 20″, 30′, 30″ being used, such as coupling the first and second return terminals 212 and 312 to the shared return terminal 313 during dual monopolar configuration through a steering relay 315 (
With continued reference to
The controllers 204 and 304 may include a processor (not shown) operably connected to a memory (not shown), which may include one or more of volatile, non-volatile, magnetic, optical, or electrical media, such as read-only memory (ROM), random access memory (RAM), electrically-erasable programmable ROM (EEPROM), non-volatile RAM (NVRAM), or flash memory. The processor may be any suitable processor (e.g., control circuit) adapted to perform the operations, calculations, and/or set of instructions described in the present disclosure including, but not limited to, a hardware processor, a field programmable gate array (FPGA), a digital signal processor (DSP), a central processing unit (CPU), a microprocessor, and combinations thereof. Those skilled in the art will appreciate that the processor may be substituted for by using any logic processor (e.g., control circuit) adapted to perform the calculations and/or set of instructions described herein.
Each of the controllers 204 and 304 is operably connected to the respective power supplies 206 and 306 and/or RF inverters 208 and 308 allowing the processor to control the output of the first RF source 202 and the second source 302 of the generator 100 according to either open and/or closed control loop schemes. A closed loop control scheme is a feedback control loop, in which a plurality of sensors measures a variety of tissue and energy properties (e.g., tissue impedance, tissue temperature, output power, current and/or voltage, etc.), and provide feedback to each of the controllers 204 and 304. The controllers 204 and 304 then control their respective power supplies 206 and 306 and/or RF inverters 208 and 308, which adjust the DC and/or RF waveform, respectively.
The generator 100 according to the present disclosure may also include a plurality of sensors 216 and 316, each of which monitors output of the first RF source 202 and the second RF source 302 of the generator 100. The sensors 216 and 316 may be any suitable voltage, current, power, and impedance sensors. In the embodiment illustrated in
In further embodiments, the sensors 216 and 316 may be coupled to the power supplies 206 and 306 and may be configured to sense properties of DC current supplied to the RF inverters 208 and 308. The controllers 204 and 304 also receive input signals from the display 120 and the input controls 122 of the generator 100 and/or the instruments 30′ and 30″. The controllers 204 and 304 adjust power outputted by the generator 100 and/or perform other control functions thereon in response to the input signals.
The RF inverters 208 and 308 includes a plurality of switching elements 228a-228d and 328a-328d, respectively, which are arranged in an H-bridge topology. In embodiments, RF inverters 208 and 308 may be configured according to any suitable topology including, but not limited to, half-bridge, full-bridge, push-pull, and the like. Suitable switching elements include voltage-controlled devices such as transistors, field-effect transistors (FETs), combinations thereof, and the like. In embodiments, the FETs may be formed from gallium nitride, aluminum nitride, boron nitride, silicon carbide, or any other suitable wide bandgap materials.
The controllers 204 and 304 are in communication with the respective RF inverters 208 and 308, and in particular, with the switching elements 228a-228d and 328a-328d. Controllers 204 and 304 are configured to output control signals, which may be pulse-width modulated (“PWM”) signals, to switching elements 228a-228d and 328a-328d. In particular, controller 204 is configured to modulate a control signal d1 supplied to switching elements 228a-228d of the RF inverter 208 and the controller 304 is configured to modulate a control signal d2 supplied to switching elements 328a-328d of RF inverter 308. The control signals d1 and d2 provide PWM signals that operate the RF inverters 208 and 308 at their respective selected carrier frequency. Additionally, controller 204 and 304 are configured to calculate power characteristics of output of the first RF source 202 and the second source 302 of the generator 100, and control the output of the first RF source 202 and the second source 302 based at least in part on the measured power characteristics including, but not limited to, voltage, current, and power at the output of RF inverters 208 and 308.
With reference to
The RF waveforms have different carrier frequencies, such that the first RF waveform has a first carrier frequency and the second RF waveform has a second carrier frequency. The two different carrier frequencies are selected such that the controllers 204 and 304 can discriminate or separate measurement data in the frequency domain. The measurement data is collected by the sensors 216 and 316 which monitor the output of the first RF source 202 and the second source 302. The controllers 204 and 304 analyze their respective first and second RF waveforms using any suitable band pass technique or any technique which transforms the measurement data to the frequency domain, such as discrete Fourier transform (DFT) and fast Fourier transform (FFT). In embodiments, the controllers 204 and 304 may use arrays of Goertzel filters which are pointed to the carrier frequency and its harmonics of the RF waveform for continuous waveforms (e.g., those used during cut mode). With respect to discontinuous waveforms, the Goertzel filters are pointed to the repetition rate and harmonics of the repetition frequency of the waveform being analyzed. The filtering of measurement data may be performed by applications, e.g., software instructions, executable by the controllers 204 and 304.
The frequencies for the first and second RF waveforms are selected to provide sufficient channel separation between the carrier frequencies of the first RF waveform and the second RF waveform as determined by the band pass Goertzel filters. With reference to a frequency response plot 350 of
With reference to
In embodiments, where both the first and second RF waveforms are discontinuous, the limited frequency space may be constraining. Discontinuous waveforms may have a repetition rate from about 20 KHz to about 490 KHz. The repetition rate does not allow for a completely orthogonal solution from a signal processing standpoint. The technique for determining the power value for each of the first RF source 202 and the second source 302 to be used for independent control is dependent on the level of cross-conductance. Cross-conductance results in real power deposited at the contact impedance. Thus, the power to control is based on the sum of cross-conductance power deposited at the contact impedance site and port source power deposited at the contact impedance. In embodiments, power deposited in the non-contact tissue impedance and the return electrode pad 26 may also be included in the overall calibration of a specific RF port. If frequency discrimination is used for power control, prior to use the generator 100, the instruments 30′ and 30″, and the return electrode pad 26 are used in a calibration procedure, which takes into account both cable compensation for cables 34′ and 34″ and the return line 28 as well as harmonic overlap and cross-conductance. Cross-conductance may also be monitored as a mitigation to potential dosage errors.
In embodiments, where one the first and second RF waveforms is continuous while the other is discontinuous, the continuous RF waveform may be at the higher Goertzel frequency of about 481 KHz and the discontinuous RF waveform may be at a lower frequency of about 433 KHz, such that there is very little interference that happens between the sources due to the frequency response of the Goertzel being divisible by 45 (see
In embodiments, where the first and second RF waveforms are continuous, since the continuous waveforms are generally not a perfect sine wave, the pre-selected unique carrier frequencies of 433 KHz and 481 KHz also comply with coherent sampling rules used to separate the continuous RF sources in combination with a Goertzel filter to provide attenuation of the interfering constructive or destructive signal from the other source. A band pass filter provides a signal pass-band region and lower/upper signal rejection regions. The level of rejection is variable and based on the type of band pass filter designed. Finite impulse response (FIR) filters provide a sinc function (sin x/x) type magnitude vs frequency response. The implementation of a computationally efficient Goertzel filter acts like a sampling function as shown in plots 350 and 360 of
With reference to
During operation, each of the first RF source 202 and the RF second source 302 output a first and second RF waveforms continuously while the mode is active. The first and second RF waveforms are segregated in the frequency domain and are measured by the sensors 216 and 316 to measure impedance of the tissue and electrical properties of the waveforms.
The first and second RF waveforms may be supplied simultaneously. During simultaneous RF waveform transmission, the sensors 216 and 316 measure properties of the first and second RF waveforms. RF waveform carrier frequencies and coagulation repetition rates may be chosen to provide coherent sampling under time critical power computation update rates. The controllers 204 and 304 utilize signal processing techniques and/or time-multiplexing techniques to discriminate between simultaneous activated first and second interrogation waveforms. The controllers 204 and 304 also determine level of cross-conductance between the first RF source 202 and the second RF source 302. First and second RF waveform carrier frequencies are such that the carrier frequencies provide coherent sampling under time critical power computation update rates and to provide a combination of effective frequency discrimination as well as for detection of cross-conductance. Carrier frequency ratios may be varied between 45:50 Goertzel ratios to 49:51 Goertzel ratios to provide for different response rates for tissue contact detection, e.g., differentiating from an open circuit. Time cascaded Goertzel computations may also be used to provide a smaller interval of time between power computations for algorithm.
In embodiments, optimal frequencies for the first and second waveforms may be determined by scanning frequency response of the first RF source 202 and the second RF source 302 and identifying noise frequencies. Following identifying noise carrier frequencies, quieter frequencies are selected to avoid corruption of the first and second interrogation waveforms thereby avoiding false detection of tissue contact.
The sensors 216 and 316 in conjunctions with the respective controllers 204 and 304 perform a wide band measurement of each first and second RF waveforms while at the same time detecting cross-conductance between the first RF source 202 and the second RF source 302. In addition, during operation the controllers 204 and 304 also provide over current protection during dual activation by monitoring the total current through the return electrode pad 26. The controllers 204 and 304 compute an overcurrent value by squaring an instantaneous current value (I2) as a moving value during any suitable time period, which may be from about 15 seconds to about 60 seconds. The moving value may be calculated every second or at any other suitable repetition rate. The overcurrent value is then compared to an overcurrent threshold, which may be about 30 A2, and if the threshold is exceeded in any 60 second window as monitored at the set rate (e.g. once per second), then both the RF source 202 and the second RF source 302 are shut off.
Each of the controllers 204 and 304 also utilize a signal processing technique, namely, the Goertzel array plots described above, to discriminate between simultaneously activated the first RF source 202 and the second RF source 302. The controllers 204 and 304 are also configured to determine a level of cross-conductance between first RF source 202 and the second RF source 302, if any, using the signal processing discrimination technique. After the level of cross-conductance is determined, the level of cross-conductance is used as a safety mitigator, namely, as a dosage error monitor, during simultaneous monopolar or bipolar RF operation. In particular, upon detection of cross-conductance by either of the controllers 204 or 304, each of the controllers 204 and 304 is configured to output an alarm and/or shut down both the first RF source 202 and the second RF source 302 in response to the cross-conductance dosage error.
While several embodiments of the disclosure have been shown in the drawings and/or described 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. Those skilled in the art will envision other modifications within the scope of the claims appended hereto.
The present application claims the benefit of and priority to U.S. Provisional Patent Applications Nos. 63/028,049, 63/028,009, 63/028,012, and 63/028,007, each of which were filed on May 21, 2020. The entire contents of each of the foregoing applications are incorporated by reference herein.
| Number | Date | Country | |
|---|---|---|---|
| 63028049 | May 2020 | US | |
| 63028009 | May 2020 | US | |
| 63028012 | May 2020 | US | |
| 63028007 | May 2020 | US |
