WO1996039088A1 - Digital waveform generation for electrosurgical generators - Google Patents

Digital waveform generation for electrosurgical generators Download PDF

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Publication number
WO1996039088A1
WO1996039088A1 PCT/IB1996/000551 IB9600551W WO9639088A1 WO 1996039088 A1 WO1996039088 A1 WO 1996039088A1 IB 9600551 W IB9600551 W IB 9600551W WO 9639088 A1 WO9639088 A1 WO 9639088A1
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WO
WIPO (PCT)
Prior art keywords
output
electrosurgical
electrosurgical generator
serial digital
digital output
Prior art date
Application number
PCT/IB1996/000551
Other languages
French (fr)
Inventor
Michael S. Klicek
Matthew J. Sodnicar
Original Assignee
Valleylab Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US47134495A priority Critical
Priority to US08/471,344 priority
Application filed by Valleylab Inc. filed Critical Valleylab Inc.
Publication of WO1996039088A1 publication Critical patent/WO1996039088A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206Generators therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00642Sensing and controlling the application of energy with feedback, i.e. closed loop control
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00666Sensing and controlling the application of energy using a threshold value
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00684Sensing and controlling the application of energy using lookup tables
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00696Controlled or regulated parameters
    • A61B2018/00726Duty cycle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00696Controlled or regulated parameters
    • A61B2018/00761Duration

Abstract

An electrosurgical generator (10) has an improved design for generating output waveforms using a microprocessor (15). The waveforms are generated in the form of a serial digital output from the microprocessor (15). The serial digital output is transformed into an electrosurgical RF output in an amplifier stage. The improved design also includes a monitoring circuit to continuously monitor the serial digital output by time-averaging the output, and then comparing that value with a threshold. The electrosurgical generator (10) comprises a microprocessor (15), an algorithm in the microprocessor (15) capable of toggling an output port of the microprocessor (15), an output amplifier (16), an adjustable high voltage DC power supply (17), a patient circuit including an active electrode (12) and a return electrode (13). The electrosurgical generator (10) may further comprise a mode selector (20) for selecting one of a plurality of pulse patterns in the serial digital output, and a plurality of command sequences in the algorithm, where each command sequence is designed to produce one of the plurality of patterns. There may also be a tank damp circuit (22) for reducing the amplitude of voltage spikes in the electrosurgical output, and a pulse suppression circuit. The monitoring circuit comprises a low pass filter (19) and a comparator to verify operation of the waveform generator.

Description

5 DIGITAL WAVEFORM GENERATION FOR

ELECTROSURGICAL GENERATORS

Related applications incorporated herein and made a part hereof by reference were filed with the United States Patent and Trademark Office on the same date, as 10 follows:

"Power Control for an Electrosurgical Generator," U.S.S.N. 08/471 ,1 16; PC8826 ;

"A Control System for Neurosurgery," U.S.S.N. 08/470,533; PC91 62;

"Control Apparatus for Electrosurgical Generator Power Output," U.S.S.N. 15 08/468,950; PC8827;

"Exit Spark Control for an Electrosurgical Generator; U.S.S.N. 08/479,424; PC9217.

1 . Field of the Invention. This invention pertains to the design of electrosurgical generators, and more particularly to an improved design for generating

20 electrosurgical output waveforms and monitoring those waveforms to verify proper operation.

2. Background of the Disclosure. Electrosurgical generators are used for generating high frequency electrical energy for surgical use on the tissue of a patient. The high frequency electrical energy is also referred to as radio-frequency (RF)

25 energy, or as electrosurgical energy. The electrosurgical energy flows through an electrode which is manipulated by a surgeon. The electrode can be used to cut, coagulate, and/or fulgurate the tissue of the patient.

The electrosurgical energy will have an associated waveform. For example, the electrosurgical energy may be in the form of a sine wave. The waveform will 30 also have a duty cycle. For example, the sine waves may not be continuous, and may instead have the cycles separated in time by periods of zero output.

The importance of the waveform for electrosurgical generators is that different waveforms will have different tissue effects. For example, it is well known in the art that a continuous sine wave may have desirable tissue cutting

35 characteristics. Other waveforms, such as high frequency white noise, may have desirable tissue fulguration characteristics.

One of the important capabilities of electrosurgical generators is that the output waveform can be selected by the surgeon to achieve the desired surgical effect. The surgeon may sometimes desire a combination of cutting and coagulation effects, which is sometimes called a "blend" mode. To achieve these blend modes, designers of electrosurgical generators may experiment with different waveforms and duty cycles to achieve the best possible tissue effects. The commercial success of electrosurgical generators is partly based on the desirability and effectiveness of the modes or waveforms.

Digital technology has been used in prior electrosurgical generators. For example, U.S. Patent number 4,658,819 discloses an electrosurgical generator with a microprocessor controller that is used to decrease the output power with increasing patient impedance. However, there is no disclosure of digital waveform generation.

Some currently available electrosurgical generators use analog circuitry to generate the output waveforms. Other currently available electrosurgical generators use digital technology to generate output waveforms. U.S. Patent number

4,658,820 discloses a waveform generator that stores several waveforms in an MxN storage device. The storage device is loaded in a parallel fashion, and then a shift register is used to sequentially output each bit into a serial data stream.

Similarly, U.S. Patent number 4,961 ,739 discloses another digital waveform generator in which the storage device has an MxNxP storage capability with an improved memory access capability. This waveform generator allows for a greater diversity of waveforms, waveform lengths, and waveform frequencies. A shift register is also used in this waveform generator to convert a parallel data stream into a serial output. The foregoing patents are incorporated herein by reference.

Both of the foregoing digital waveform generators require hardware and circuitry associated with a shift register. It would be desirable to have a microprocessor-based signal generator that could digitally generate commands for different waveforms without the added complexity and other restraints associated with a shift register. It would also be desirable to have a fault detection circuit for the waveform generator to ensure proper operation.

SUMMARY OF THE INVENTION

An improved electrosurgical generator uses a microprocessor for waveform generation. The microprocessor has an algorithm that is capable of toggling an output port of the microprocessor to generate many different waveforms. No shift register is required. A fault detection circuit can check the output of the waveform generator to insure proper operation. A summary of the elements of the invention follows.

An electrosurgical generator may be used for applying high frequency electrosurgical energy to the tissue and bodily fluids of a patient. A microprocessor in the electrosurgical generator may have a memory capability, at least one output port, and at least one input port. A clock signal may be connected to one of the input ports of the microprocessor to provide a reference frequency.

An algorithm in the microprocessor is designed to execute a command sequence for toggling the output port. A serial digital output from the output port may thereby be created. The algorithm may be designed to continuously execute until it is reset through one of the input ports of the microprocessor.

An output amplifier in the electrosurgical generator may be capable of transforming the serial digital output into the high frequency electrosurgical energy. A field effects transistor (FET) driver circuit and a FET are most preferably included in the output amplifier. An adjustable high voltage DC power supply in electrical connection with the output amplifier may be used for adjusting the amplitude of the high frequency electrosurgical energy.

A patient circuit is connected to the electrosurgical generator. The patient circuit may include an active electrode in electrical connection with the high frequency electrosurgical energy, and a return electrode in electrical connection with the electrosurgical generator.

A mode selector on the electrosurgical generator may be used for selecting one of a plurality of pulse patterns in the serial digital output. Each pattern results in a different effect on the tissue and bodily fluids of the patient. A plurality of command sequences may be in the algorithm. Each command sequence is designed to produce one of the plurality of pulse patterns.

A tank damp circuit may be connected to the output amplifier and may be controlled by the microprocessor for reducing the amplitude of voltage spikes in the electrosurgical energy. A pulse suppression circuit may also be connected to suppress portions of the serial digital output.

A dosage error monitoring circuit can be used to monitor the serial digital output. In general, the dosage error monitor can time-average the serial digital output, and then compare that average to a safety threshold. A low-pass filter may be used to time-average the output, although other filtering and averaging techniques can be used. If a safety threshold is reached, the dosage error monitoring circuit may be used to reduce the electrosurgical output substantially to zero. A method of using an electrosurgical generator comprises the following steps: providing a microprocessor in the electrosurgical generator with a memory capability, at least one output port, and at least one input port; creating a serial digital output from the output port of the microprocessor by executing a command sequence in an algorithm in the microprocessor; transforming the serial digital output into the high frequency electrosurgical energy using an output amplifier in the electrosurgical generator; adjusting the amplitude of the high frequency electrosurgical energy with an adjustable high voltage DC power supply in electrical connection with the output amplifier, and connecting a patient circuit to the electrosurgical generator. The patient circuit may include an active electrode in electrical connection with the high frequency electrosurgical energy, and a return electrode in electrical connection with the electrosurgical generator.

Some additional steps in the method of using an electrosurgical generator can be: selecting one of a plurality of pulse patterns in the serial digital output using a mode selector on the electrosurgical generator, where each pattern results in a different effect on the tissue and bodily fluids of the patient, and providing a plurality of command sequences in the algorithm, wherein each command sequence is designed to produce one of the plurality of patterns.

The method may further comprise the step of continuously executing the command sequence until it is reset through one of the input ports of the microprocessor. The method can also comprise the step of reducing the amplitude of voltage spikes in the electrosurgical energy with a tank damp circuit which is connected to the output amplifier and is controlled by the microprocessor. There may also be a step of suppressing portions of the serial digital output using a pulse suppression circuit which is connected to the serial digital output. The method may also comprise the steps of: time averaging the serial digital output; comparing the time-averaged serial digital output against a safety threshold, and reducing the electrosurgical energy substantially to zero whenever the time- averaged serial digital output exceeds the safety threshold. BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a functional block diagram of an electrosurgical generator. Figure 2 is a schematic block diagram of a microprocessor and associated circuits for generating waveforms.

DETAILED DESCRIPTION OF THE INVENTION

Figure 1 is a partial block diagram of an electrosurgical generator 10 connected to a patient 1 1 by an active electrode 12 and a return electrode 13. The controller 14 is composed of several microcontrollers, logic circuits, and digital memory. In the preferred embodiment, these microcontrollers are Phillips/Signetics model 80C562. The microprocessor 1 5 generates a serial digital output which is subsequently used as an RF mask to generate the output waveform. An output amplifier 1 6 converts the serial digital output into an electrosurgical signal using a field effects transistor (FET). The output amplifier 1 6 also includes a tank circuit 18 which has been shown as a separate block in Figure 2.

The output amplifier 16 also has an input from an adjustable high voltage power supply 17 which effects the amplitude of the electrosurgical signal. The controller 14 and the microprocessor 15 each have inputs to the adjustable high voltage power supply 17. In the preferred embodiment, the serial digital line from the microprocessor 1 5 is sent through a low-pass filter 19 which time-averages the serial digital line. The time-averaged, or filtered, signal is sent to the controller 14. For each waveform, the controller 14 has thresholds for the expected value of the filtered signal. If the filtered signal is outside of the thresholds, an algorithm in the controller 14 will generate a fault signal which shuts off the output of the electrosurgical generator 10.

The modes for the electrosurgical generator 10 are selected from a mode selector 20 which sends a signal to the controller 14. Thresholds for the filtered signal are set in the controller 14, and the mode selection is sent to the microprocessor 15. An algorithm in the microprocessor 1 5 executes one of a plurality of command sequences based on the mode selection. Each command sequence generates a different serial digital output. A clock 21 sends timed pulses to the microprocessor 1 5 to sequence the execution of the algorithm in the microprocessor 15. Figure 2 shows a schematic diagram of the microprocessor 1 5 and some of its associated circuits. In the preferred embodiment, the microprocessor 15 is a Phillips/Signetics 87C750 which is driven with a clock operating at 28.322 MHz. The microprocessor 1 5 has on-board memory and input ports for the clock 21 , as well as other logic signals. An input from the controller 14 which enables the serial digital output is labeled "T_ON_EN" in Figure 2. The output of the mode selector 20 is input to the microprocessor 15 through one of the ports labeled, in Figure 2, "MODE 0" through "MODE 3."

The microprocessor 15 has output ports to deliver the serial digital line and other logic signals. In Figure 2, the serial digital line is labeled "T ON MICRO." An output which controls the high voltage power supply 17 is labeled "ECON GAIN."

In the preferred embodiment, the algorithm in the microprocessor 1 5 repetitively executes a series of commands that toggle the output port,

"T_ON_MICRO," of the microprocessor 15. In this disclosure, the term "toggle" means switching between a logic "on" and a logic "off" in a timed sequence to produce a serial digital output. The series of commands will be different depending on the mode which the surgeon selects. For example, in a pure cut mode, the algorithm will produce a square wave. In a blend mode, the algorithm may reduce the duty cycle by incorporating longer periods of logic "off" in the serial digital output. For one mode, i.e. the electrosurgical spray mode, a 256 byte long lookup table is stored in on-board memory which has the effect of generating a specified waveform output. The pattern will repeat each time the algorithm cycles through the lookup table.

In the preferred embodiment there is also a tank damp circuit which is shown in Figure 1 as block 22. The purpose of the tank damp circuit is to reduce the amplitude of voltage spikes in the electrosurgical output and also to reduce the leakage current. The tank damp circuit 22 is enabled by the microprocessor 1 5 through an output port labeled "TNK_DMP." The output is sent through NAND gates U10C and U10D where it is logically NANDED with a high impedance flag labeled "HI_Z." The logical output is labeled "TNK_DMP_OUT" and is sent to the tank damp circuit 22.

In the preferred embodiment there is also a pulse suppression circuit shown in Figure 2 as the logical NAND gate labeled U10; its purpose is to lower the duty cycle of the output by suppressing selected pulses from the serial digital pulse train. The pulse suppression circuit is enabled by the controller 14 when a lower duty cycle is desirable, depending on the mode selected and on the impedance of the patient tissue 1 1 . A digital signal labeled WAX is NANDED with the serial digital pulse train at U10B to yield the signal "T_ON" which is sent to the output amplifier 1 6, as shown in Figure 2.

The preferred embodiment also has a dosage error monitoring circuit composed of a filter 19 and an algorithm in the controller 14. The preferred filter 19 is shown in Figure 2 as a low-pass filter including resistor R1 5 and capacitor C16. The filtered signal, labeled "T_ON_AVG", is compared with a threshold in the controller 14 to determine if the proper waveform is being generated. If the filtered signal is too high or too low with respect to the threshold for the desired signal, then a fault condition exists and the electrosurgical generator 10 output is shut off.

It is to be understood that the above detailed description of an embodiment of the invention is provided by way of example only. Various details of design and construction may be modified without departing from the true spirit and scope of the invention as set forth in the claims.

Claims

What is claimed is:
1 . An electrosurgical generator 10, for applying high frequency electrosurgical energy to the tissue and bodily fluids of a patient 1 1 , comprising: a microprocessor 1 5 in the electrosurgical generator 10 having a memory capability, at least one output port, and at least one input port; an algorithm in the microprocessor 1 5 designed to execute a command sequence for toggling the output port and to thereby create a serial digital output; an output amplifier 16 in the electrosurgical generator 10 capable of transforming the serial digital output into the high frequency electrosurgical energy; an adjustable high voltage DC power supply 17 in electrical connection with the output amplifier 16 for adjusting the amplitude of the high frequency electrosurgical energy, and a patient circuit connected to the electrosurgical generator 10, the patient circuit including an active electrode 12 in electrical connection with the high frequency electrosurgical energy, and a return electrode 13 in electrical connection with the electrosurgical generator 10.
2. The electrosurgical generator 10 of Claim 1 further comprising: a mode selector 20 on the electrosurgical generator 10 for selecting one of a plurality of pulse patterns in the serial digital output, where each pattern results in a different effect on the tissue and bodily fluids of the patient 1 1 , and a plurality of command sequences in the algorithm, wherein each command sequence is designed to produce at least one of the plurality of patterns.
3. The electrosurgical generator 10 of Claim 1 wherein a tank damp circuit 22 is connected to the output amplifier 16 and is controlled by the microprocessor 1 5 for reducing the amplitude of voltage spikes in the electrosurgical energy.
4. The electrosurgical generator 10 of Claim 1 wherein a pulse suppression circuit is connected to the output amplifier 1 6 to suppress portions of the serial digital output.
5. An electrosurgical generator 10 for applying high frequency electrosurgical energy to a patient 1 1 comprising: a pulse generator in the electrosurgical generator 10 for creating a serial digital output; a dosage error monitoring circuit comprising a filter 19 connected for time averaging the serial digital output and a comparator for comparing the filtered serial digital output against a safety threshold; an output amplifier 1 6 in the electrosurgical generator 10 capable of receiving and transforming the serial digital output into the high frequency electrosurgical energy; an adjustable high voltage DC power supply 17 in electrical connection with the output amplifier 1 6 for adjusting the amplitude of the high frequency electrosurgical energy, and a patient circuit connected to the electrosurgical generator 10, the patient circuit including an active electrode 12 in electrical connection with the high frequency electrosurgical energy, and a return electrode 13 in electrical connection with the electrosurgical generator 10.
6. A method of using an electrosurgical generator 10 for applying high frequency electrosurgical energy to the tissue and bodily fluids of a patient 1 1 , the method comprising the steps of: providing a microprocessor 15 in the electrosurgical generator 10 with a memory capability, at least one output port, and at least one input port; creating a serial digital output from the output port of the microprocessor 1 5 by executing a command sequence in an algorithm in the microprocessor 1 5; transforming the serial digital output into the high frequency electrosurgical energy by using an output amplifier 16 in the electrosurgical generator 10; adjusting the amplitude of the high frequency electrosurgical energy with an adjustable high voltage DC power supply 17 in electrical connection with the output amplifier 1 6, and connecting a patient circuit to the electrosurgical generator 10, the patient circuit including an active electrode 1 2 in electrical connection with the high frequency electrosurgical energy, and a return electrode 13 in electrical connection with the electrosurgical generator 10.
7. The method of using an electrosurgical generator 10 in Claim 6 further comprising the steps of: selecting one of a plurality of pulse patterns in the serial digital output using a mode selector 20 on the electrosurgical generator 10, where each pattern results in a different effect on the tissue and bodily fluids of the patient 1 1 , and providing a plurality of command sequences in the algorithm, wherein each command sequence is designed to produce one of the plurality of patterns.
8. The method of using an electrosurgical generator 10 in Claim 6 further comprising the step of reducing the amplitude of voltage spikes in the electrosurgical energy with a tank damp circuit 22 which is connected to the output amplifier 16 and is controlled by the microprocessor 15.
9. The method of using an electrosurgical generator 10 in Claim 6 further comprising the step of suppressing portions of the serial digital output using a pulse suppression circuit which is connected to the serial digital output.
10. A method of using an electrosurgical generator 10 for applying high frequency electrosurgical energy to the tissue and bodily fluids of a patient 1 1 , the method comprising the steps of: creating a serial digital output using a pulse generator in the electrosurgical generator 10; time averaging the serial digital output; comparing the time-averaged serial digital output against a safety threshold; transforming the serial digital output into the high frequency electrosurgical energy; adjusting the amplitude of the high frequency electrosurgical energy with an adjustable high voltage DC power supply 17 in electrical connection with the output amplifier 1 6, and providing a patient circuit connected to the electrosurgical generator 10, the patient circuit including an active electrode 12 in electrical connection with the high frequency electrosurgical energy, and a return electrode 13 in electrical connection with the electrosurgical generator 10.
PCT/IB1996/000551 1995-06-06 1996-06-03 Digital waveform generation for electrosurgical generators WO1996039088A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US47134495A true 1995-06-06 1995-06-06
US08/471,344 1995-06-06

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CA 2220909 CA2220909C (en) 1995-06-06 1996-06-03 Digital waveform generation for electrosurgical generators
AU57009/96A AU710400B2 (en) 1995-06-06 1996-06-03 Digital waveform generation for electrosurgical generators
JP50026097A JPH10506564A (en) 1995-06-06 1996-06-03 Digital waveform generator for electrosurgical generator
EP96915135A EP0836433A1 (en) 1995-06-06 1996-06-03 Digital waveform generation for electrosurgical generators

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WO1996039088A1 true WO1996039088A1 (en) 1996-12-12

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EP (1) EP0836433A1 (en)
JP (1) JPH10506564A (en)
AU (1) AU710400B2 (en)
CA (1) CA2220909C (en)
WO (1) WO1996039088A1 (en)

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JPH10506564A (en) 1998-06-30
CA2220909A1 (en) 1996-12-12
CA2220909C (en) 2001-02-27
AU5700996A (en) 1996-12-24
AU710400B2 (en) 1999-09-16
EP0836433A1 (en) 1998-04-22

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