US20080281315A1 - Electrosurgical Generator With Adaptive Power Control - Google Patents
Electrosurgical Generator With Adaptive Power Control Download PDFInfo
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- US20080281315A1 US20080281315A1 US12/136,551 US13655108A US2008281315A1 US 20080281315 A1 US20080281315 A1 US 20080281315A1 US 13655108 A US13655108 A US 13655108A US 2008281315 A1 US2008281315 A1 US 2008281315A1
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Classifications
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- H—ELECTRICITY
- H03—ELECTRONIC CIRCUITRY
- H03L—AUTOMATIC CONTROL, STARTING, SYNCHRONISATION, OR STABILISATION OF GENERATORS OF ELECTRONIC OSCILLATIONS OR PULSES
- H03L5/00—Automatic control of voltage, current, or power
- H03L5/02—Automatic control of voltage, current, or power of power
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical 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
- A61B18/1206—Generators therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00696—Controlled or regulated parameters
- A61B2018/00702—Power or energy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00696—Controlled or regulated parameters
- A61B2018/00761—Duration
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00773—Sensed parameters
- A61B2018/00875—Resistance or impedance
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00773—Sensed parameters
- A61B2018/00886—Duration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical 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
- A61B18/1206—Generators therefor
- A61B2018/124—Generators therefor switching the output to different electrodes, e.g. sequentially
Definitions
- the present invention relates to an electrosurgical generator with an adaptive power control, and more particularly to an electrosurgical generator that controls the output power in a manner that causes impedance of tissue to rise and fall cyclically until the tissue is completely desiccated.
- Electrosurgical generators are used by surgeons to cut and coagulate tissue of a patient.
- High frequency electrical power is produced by the electrosurgical generator and applied to the surgical site by an electrosurgical tool.
- Monopolar and bipolar configurations are common in electrosurgical procedures.
- Electrosurgical generators are typically comprised of power supply circuits, front panel interface circuits, and RF output stage circuits. Many electrical designs for electrosurgical generators are known in the field. In certain electrosurgical generator designs, the RE output stage can be adjusted to control the RMS output power. The methods of controlling the RF output stage may comprise changing the duty cycle, or changing the amplitude of the driving signal to the RF output stage. The method of controlling the RF output stage is described herein as changing an input to the RF output stage.
- Electrosurgical techniques have been used to seal small diameter blood vessels and vascular bundles.
- tissue welding Another application of electrosurgical energy is tissue welding.
- tissue welding is similar to vessel sealing, except that a vessel or duct is not necessarily sealed in this process.
- tissue welding may be used instead of staples for surgical anastomosis.
- Electrosurgical power has a desiccating effect on tissue during tissue welding or vessel sealing.
- electrosurgical desiccation is meant to encompass any tissue desiccation procedure, including standard electrosurgical coagulation, desiccation, vessel sealing, and tissue welding.
- One of the problems associated with electrosurgical desiccation is undesirable tissue damage due to thermal effects.
- the tissue at the operative site is heated by the electrosurgical current. Healthy tissue adjacent to the operative site can become thermally damaged if too much heat is allowed to build up at the operative site. The heat may conduct to the adjacent tissue and cause a large region of tissue necrosis. This is known as thermal spread.
- thermal spread becomes important when electrosurgical tools are used in close proximity to delicate anatomical structures. Therefore, an electrosurgical generator that reduced the possibility of thermal spread would offer a better opportunity for a successful surgical outcome.
- Eschar is a deposit on an electrosurgical tool that is created from tissue that is desiccated and then charred by heat.
- the surgical tools win often lose effectiveness when they are coated with eschar.
- the buildup of eschar could be reduced when less heat is developed at the operative site.
- a measurement of electrical impedance of tissue is a good indication of the state of desiccation of the tissue.
- electrosurgical generators can automatically terminate output power based on a measurement of impedance.
- Several methods for determining the optimal point of desiccation are known in the field. One method sets a threshold impedance, and terminates power once the measured impedance of the tissue crosses the threshold. Another method terminates power based on dynamic variations in the impedance.
- FIG. 2 in the Vallfors article shows impedance as a function of time during heating of tissue.
- Valfors reports that the impedance value of tissue proved to be close to minimal at the moment of coagulation.
- Vallfors suggests a micro-computer technique for monitoring the minimum impedance and subsequently terminating output power to avoid charring the tissue.
- the Bergdahl article reported that the impedance had a minimum value at the moment of coagulation.
- the Bergdahl article also reported that it was not possible to coagulate safely arteries with a diameter larger than 2 to 2.5 millimeters.
- the present invention helps to overcome this limitation by enabling electrosurgical vessel seating of larger diameter vessels.
- U.S. Pat. No. 5,540,684 discloses a method and apparatus for electrosurgically treating tissue in a manner similar to the disclosures of Vallfors and Bergdahl.
- the '684 patent addresses the problem associated with turning off the RF output automatically after the tissue impedance has reached a minimum value.
- a storage device records maximum and minimum impedance values, and an algorithm computes an optimal time for terminating output power.
- U.S. Pat. No. 4,191,188 discloses a variable crest factor electrosurgical generator.
- the crest factor is disclosed to be associated with the coagulation effectiveness of the electrosurgical waveform.
- U.S. Pat. No. 5,472,443 discloses the variation of tissue impedance with temperature. The impedance of tissue is shown to fall, and then subsequently rise as the temperature is increased.
- the '443 patent shows a relatively lower temperature region (Region A in FIG. 2 ) where salts, contained within the body fluids, are believed to dissociate, thereby decreasing the electrical impedance.
- the relatively next higher temperature region (Region B) is where the water in the tissues boils away, causing the impedance to rise.
- the relatively highest region (Region C) is where the tissue becomes charred, resulting in a slight lowering of impedance.
- electrosurgical generator that produced a clinically effective output and, in addition, reduced the amount of heat and thermal spread at the operative site. It would also be desirable to have an electrosurgical generator that produced a better quality seal for vessel sealing and tissue welding operations. It would also be desirable to have an electrosurgical generator that desiccated tissue by applying a minimal amount of electrosurgical energy.
- an electrosurgical generator for applying output power to tissue.
- the electrosurgical generator includes a tissue impedance measurement circuit configured to measure tissue impedance and a controller coupled to the tissue impedance measurement circuit.
- the controller is adapted to cycle output power from the electrosurgical generator to cause a cycling of the tissue impedance by applying the output power to tissue and then adjusting the output power to at least one of a lower output value and termination of output power.
- the controller is further adapted to re-apply the output power to tissue if tissue impedance does not indicate tissue desiccation and to terminate output power when the measured tissue impedance indicates tissue desiccation.
- an electrosurgical generator for treating tissue by applying energy.
- the electrosurgical generator includes a desiccation detector configured to determine completeness of tissue desiccation and a controller coupled to the desiccation detector.
- the controller is adapted to cycle output power to cause a cycling of tissue impedance in response to the degree of tissue desiccation.
- the controller is further adapted to re-apply the output power to tissue if the desiccation detector does not indicate tissue desiccation.
- a method for applying electrosurgical energy to tissue to treat tissue includes the steps of: a) cycling output power from an electrosurgical generator to cause a cycling of tissue impedance by applying output power to tissue and then adjusting output power to at least one of a lower output value and termination of output power and re-applying output power to tissue if tissue impedance does not indicate tissue desiccation.
- the method also includes the steps of c) allowing the tissue impedance to fall to a predetermined minimum value and then raising the output power to cause an increase in tissue impedance and d) repeating steps b and c until tissue impedance at least reaches a predetermined value that corresponds to tissue desiccation.
- FIG. 1 is a block diagram representation of an adaptive oscillatory power curve according to the present invention.
- FIG. 2( a ) is a sample of experimental data for a standard vessel sealing operation, showing output power as function of time.
- FIG. 2( b ) is a sample of experimental data for a standard vessel sealing operation, showing load impedance as a function of time.
- FIG. 2( c ) is a sample of experimental data for a standard vessel sealing operation, showing output current as a function of time.
- FIG. 2( d ) is a sample of experimental data for a standard vessel sealing operation, showing output voltage as a function of time.
- FIG. 3( a ) is a sample of experimental data for an adaptive power control generator, showing output power as fiction of time.
- FIG. 3( b ) is a sample of experimental data for an adaptive power control generator, showing load impedance as a function of time.
- FIG. 3( c ) is a sample of experimental data for an adaptive power control generator, showing output current as a function of time.
- FIG. 3( d ) is a sample of experimental data for an adaptive power control generator, showing output voltage as a function of time.
- FIG. 4( a ) is a representation of a power curve for a standard electrosurgical generator.
- FIG. 4( b ) is a representation of an adaptive oscillatory power curve.
- the present invention discloses an adaptive, oscillatory power curve which is able to reduce thermal spread in each of these areas by applying power in a cyclical fashion, rather than continuously.
- thermal energy is allowed to dissipate which reduces direct thermal conduction.
- steam exits the weld site in smaller bursts, which produces less thermal damage than one large burst.
- impedance between the jaws of the electrosurgical instrument is kept low, which allows current to flow more directly between the jaws.
- Charring is also reduced. High voltages contribute to tissue charring, which is why it is preferable to limit the output voltage of the electrosurgical generator to 120 volts, and to periodically reduce it to a lower value during power cycling. A relatively low voltage is also important because it prevents electrical sparks, or arcs, from passing through the tissue and burning small holes in the newly sealed, or welded, tissue.
- FIG. 1 a block diagram of an adaptive oscillatory power control system 10 is shown.
- the line designated by the letter A represents the command input signal to the control system 10 .
- the command input signal A is preferably a periodic function, and in stain embodiments the period may vary depending on the dynamics of the tissue.
- the signal A is representative of the desired tissue impedance.
- a measurement of tissue impedance is represented by line B.
- a summing block 11 compares the command input signal A with the measured tissue impedance B to produce a difference signal C.
- the summing block 11 may be comprised of an electrical comparator circuit as is commonly known to control systems engineers.
- the difference signal C may be input to a controller 12 that generates a control signal D.
- the control signal D adjusts or terminates the output power of the electrosurgical generator by changing the state of the RF. Output Stage 13 .
- the controller 12 may be comprised of an algorithm in a microprocessor that determines the conditions for power termination based on the amplitude of the control signal. Alternatively and equivalently, the controller 12 may be connected directly to the measured tissue impedance B to terminate power based on the amplitude of the measured tissue impedance B.
- the controller 12 may be comprised of any combination of proportional integral, and derivative control laws that are known to control system engineers. Other types of control laws, such as “bang-bang” control laws, are effective equivalents.
- the command input signal A has a cyclic pattern, for example a sine wave or a square wave.
- the cyclic nature of the command input signal A causes the control system 10 to regulate the output power in a cyclic manner to achieve beneficial surgical effects.
- the controller 12 monitors the difference signal C to determine the response of the output power E. In one embodiment, when the difference signal C is large, and the impedance measurement B is above threshold, then the controller 12 terminates the output power E.
- the control signal D is preferably connected to an R.F. Output Stage 13 .
- the control signal D preferably changes a driving voltage in the R.F. output stage to thereby change the RMS output power from the electrosurgical generator, shown as line E in FIG. 1 .
- the control signal D may change the duty cycle of the R.F. Output Stage 13 thereby effectively changing the RMS output power.
- Other means of changing RMS output power from an R.F. Output Stage, such as changing current, are known to electrical engineers.
- the generator R.F. Output Stage 13 causes the electrosurgical generator to output a power level E to the tissue 14 of the patient.
- the tissue 14 becomes desiccated, thereby changing the electrical impedance, shown by F in FIG. 1 .
- the electrical impedance F of the tissue is measured by an impedance measurement circuit 15 and reported as the measured tissue impedance B.
- the impedance measurement circuit 15 may be any form of electrical circuit that measures, or estimates, electrical impedance.
- the measured tissue impedance B is preferably an electrical signal that is proportional to the actual tissue impedance F.
- output power from an electrosurgical generator can be adjusted in several ways.
- the amplitude of the output power can be adjusted.
- the output power can be adjusted by changing the duty cycle or the crest factor.
- the change or adjustment in output power is meant to refer any change or adjustment in the root mean square (RMS) value of the output power of the electrosurgical generator.
- RMS root mean square
- the control system 10 is designed to cycle the tissue impedance F for preferably several cycles in order to achieve beneficial effects.
- the command input signal A is a cyclically varying signal such as a sine wave.
- An example of cyclical impedance behavior of tissue is shown in FIG. 3( b ).
- the generator output power that caused the cyclical impedance behavior is shown in FIG. 3( a ).
- the cyclical behavior of the present invention can be contrasted with a standard electrosurgical generator wherein the output power is shown in FIG. 2( a ) and the tissue impedance is shown in 2 ( b ).
- the present invention discloses an adaptive, oscillatory power curve which is able to reduce thermal spread in each of these areas by applying power in a cyclical fashion, rather than continuously.
- thermal energy is allowed to dissipate which reduces direct thermal conduction.
- steam exits the weld site in smaller bursts, which produces less thermal damage than one large burst.
- impedance between the jaws of the electrosurgical instrument is kept low, which allows current to flow more directly between the jaws.
- Charring is thought to be reduced by the present invention. High voltages contribute to tissue charring, which is why it is preferable to limit the output voltage of the electrosurgical generator to 120 volts, and to periodically reduce it to a lower value during power cycling. A relatively low voltage is also important because it prevents electrical sparks, or arcs, from passing through the tissue and burning small holes in the newly sealed, or welded, tissue.
- a plot of output power vs. load impedance is called a “power curve.”
- a representation of a standard power curve is shown in FIG. 4( a ).
- the output is typically current limited, and this is shown as the “constant current” line segment on FIG. 4( a ).
- the electrosurgical generator has a power control system that maintains the output power at a constant level by adjusting the output voltage, as shown by the “constant power” line segment on FIG. 4( a ).
- the load impedance becomes large, and the output power cannot be maintained without applying unacceptably high output voltages.
- a voltage limit is reached, and the output power drops off because the output current is falling and the output voltage is at a limit.
- the drop in output power is shown as the “constant voltage” line segment in FIG. 4( a ).
- the present invention is related to an electrosurgical generator having an adaptive oscillatory power curve as shown in FIG. 4( b ).
- the adaptive oscillatory power curve is produced by a power control system in the electrosurgical generator.
- the design details of the control system can be implemented in several ways which are well known to control system engineers.
- the first part of the adaptive oscillatory power curve is similar to the standard power curve, wherein the generator applies high current into a low impedance load until a maximum power limit, shown as A, is reached.
- A maximum power limit
- line segment B output current begins to fall, and output voltage begins to rise as the generator adjusts the output voltage to maintain constant output power at the level marked by A.
- the generator then begins looking for signs to indicate the onset of boiling in the tissue. Such signs include a very rapid rise in impedance, or a high value of voltage, such as 120 volts.
- the local maximum of the impedance curve is shown by letter K in FIG. 4( b ).
- the output power drops to the level indicated by H in FIG. 4( b ).
- H may be zero watts.
- desiccation stops and the tissue impedance starts to fall.
- the cyclical portion of the power curve incorporating line segments B, D, and E is an important part of this invention and will continue until the tissue is desiccated.
- the power will terminate as shown when impedance reaches point L.
- point L will be substantially the same as point K.
- FIG. 4( b ) The behavior shown in FIG. 4( b ) can be observed in FIGS. 3( a ), 3 ( b ), 3 ( c ) and 3 ( d ).
- Power oscillations between 120 watts and 20 watts in FIG. 3( a ) correspond to cyclical movement between power level A and power level H in FIG. 4( b ).
- Impedance oscillations in FIG. 3( b ) correspond to cyclical movement between impedance level K and impedance level J in FIG. 4( b ). It will be understood by control systems engineers that FIG. 4( b ) is highly idealized, and the cyclical behavior may not always reach exactly the same local maxima and minima. This can be observed in FIG. 3( a ), where the local maxima of the power curve may not always reach 120 volts.
- the initial high output power initiates boiling in the tissues.
- the subsequent low output power is insufficient to maintain boiling, and hence boiling in the tissue stops.
- the impedance will fall to a lower value.
- the low impedance allows output power to increase, which re-heats the tissue to the point of boiling.
- the voltage is also pulled higher during the process, and remains so until the power curve can sense the onset of boiling, and lower the voltage, preferably back to 50 volts.
- the process continues until the tissue is fully desiccated.
- An oscillation is one cycle of high output power followed by low output power.
- FIGS. 2( a ) through 2 ( d ) show experimental results on tissue samples using a standard power curve.
- FIGS. 3( a ) through 3 ( d ) show experimental results using an adaptive oscillatory power curve.
- the general nature of the invention can be seen by comparing FIG. 2( a ) with FIG. 3( a ).
- FIG. 2( a ) shows a 100 watt electrosurgical output that is applied continuously to tissue. As the tissue desiccates, the impedance of the tissue rises and the output power in FIG. 2( a ) is seen to fall off below 20 watts.
- FIG. 3( a ) shows an oscillating output power that varies from approximately 100 watts to approximately 20 watts.
- tissue impedance can be seen by comparing FIG. 2( b ) with FIG. 3( b ).
- the tissue impedance resulting from the standard power curve is shown to continuously increase in FIG. 2( b ), perhaps after an initial drop.
- the tissue impedance resulting from the adaptive oscillatory power curve is shown to oscillate in FIG. 3( b ) and thus has several local minima.
- Output voltage and output current show a cyclic behavior in the adaptive oscillatory power curve.
- the cyclic behavior is absent in the standard power curve.
- FIGS. 2( c ) and 3 ( c ) can be compared to show the difference in output current between the standard power curve and the adaptive oscillatory power curve. In each case the maximum output current rises above 2 amps RMS.
- FIGS. 2( d ) and 3 ( d ) can be compared to show the difference in output voltage between the standard power curve and the adaptive oscillatory power curve.
- a voltage limit preferably in each case 120 volts, prevents arcing that might leave pinholes in the tissue seal.
- the generator temporarily lowers the output voltage limit to 50 volts whenever the output voltage reaches 120 volts. This causes a reduction in output power, and if the tissue is not completely desiccated, a corresponding significant reduction in tissue impedance. After the reduction in tissue impedance, the output voltage limit is reset to 120 volts, allowing a rise in output power. This reduction and subsequent rise in output power constitutes a cycle.
- control system can properly create the adaptive oscillatory power curve based on measurements of time, and output voltage.
- Table 1 shows a comparison between two sets of tests which compare a standard power curve with an adaptive oscillatory power curve.
- Test 1 indicates use of the standard power curve
- Test 2 indicates the use of the adaptive oscillatory power curve.
- Size indicates the vessel diameter in millimeters
- burst pressures are measured in p.s.i., sticking, charring, and clarity are subjective measures ranked from 0 to 3, (where 0 represents a low value for sticking and charring, and 0 represents a poor value for clarity), and ts indicates thermal spread, measured in millimeters.
- Table 1 illustrates that the adaptive oscillatory power curve (Test 2) has several advantages over the standard power curve (Test 1). Most notable is the lower amount of thermal spread: a mean value of 2.1 mm for the standard power curve, and 1.65 mm for the adaptive oscillatory power curve. The subjective measures for sticking, charring and clarity of the weld show that the adaptive oscillatory power curve offer improvements over the standard power curve.
- the invention is an electrosurgical generator for treating tissue, wherein the electrosurgical generator comprises a circuit for generating a measurement of the load impedance, and an output power controller having means for inducing multiple oscillations of the load impedance in response to the measurement.
- the load impedance refers to the impedance of the tissue being treated by the electrosurgical generator.
- the circuit for generating a measurement of the load impedance can be analog or digital, and typically requires an output voltage sensor and an output current sensor. The output voltage is divided by the output current to compute a measurement of load impedance.
- the means for inducing multiple oscillations of the load impedance preferably comprises a control system which can selectively control the output voltage to cause appropriate oscillations of the output power.
- an output power control circuit has an adjustable voltage supply connected to the primary side of an isolation transformer. The secondary winding of the transformer is connected to an output resonant circuit. The voltage supply has an adjuster for changing the voltage to the transformer, and thereby changing the output voltage of the electrosurgical generator. A digital signal may be used to control the voltage supply.
- the means for inducing multiple oscillations preferably comprise a feedback control system, where the feedback is a measurement of the load impedance.
- the control system preferably includes an algorithm in a microprocessor.
- the algorithm in the microprocessor can monitor the load impedance and determine how the load impedance is responding to a change in the output power.
- the control system sets an output voltage limit of 120 volts RMS, and then controls the output power to a user desired setting, for example 100 watts.
- a high current will combine with an output voltage of less than 120 volts to yield the desired power of 100 watts.
- the control system will automatically lower the output voltage to a low value, preferably 50 volts. This effectively lowers the output power. If the tissue is not completely desiccated, the lower output power will cause the impedance to drop significantly.
- the output voltage limit is reset to 120 volts by the control system, and the cycle repeats. It has been found through experimentation that the oscillations of the load impedance will occur in the frequency range of one to twenty hertz, and this range has been referred to herein as the thermal bandwidth.
- the control system terminates the output power after a set period of time which was three seconds. Alternatively, the control system can terminate power when the impedance reaches a threshold of 2000 ohms. Another alternative is to terminate output power when the measurement of impedance indicates that the impedance does not substantially fall in response to a drop in the output power.
- the present invention is applicable to any form of electrosurgical coagulation.
- the benefits of the present invention including reduced thermal spread, less eschar buildup, and improved desiccation, can be applied to both monopolar and bipolar electrosurgical generator outputs. While a particular preferred embodiment has been illustrated and described, the scope of protection sought is in the claims that follow.
Abstract
Description
- This application is a continuation of U.S. patent application Ser. No. 10/434,019, filed on May 8, 2003, which is a reissue of U.S. patent application Ser. No. 09/209,323, now U.S. Pat. No. 6,228,080, filed on Dec. 11, 1998, which is a continuation of U.S. patent application Ser. No. 08/838,548, filed on Apr. 9, 1997, now U.S. Pat. No. 6,033,399, the contents of which are incorporated herein by reference.
- 1. Field of the Invention
- The present invention relates to an electrosurgical generator with an adaptive power control, and more particularly to an electrosurgical generator that controls the output power in a manner that causes impedance of tissue to rise and fall cyclically until the tissue is completely desiccated.
- 2. Background of the Disclosure
- Electrosurgical generators are used by surgeons to cut and coagulate tissue of a patient. High frequency electrical power is produced by the electrosurgical generator and applied to the surgical site by an electrosurgical tool. Monopolar and bipolar configurations are common in electrosurgical procedures.
- Electrosurgical generators are typically comprised of power supply circuits, front panel interface circuits, and RF output stage circuits. Many electrical designs for electrosurgical generators are known in the field. In certain electrosurgical generator designs, the RE output stage can be adjusted to control the RMS output power. The methods of controlling the RF output stage may comprise changing the duty cycle, or changing the amplitude of the driving signal to the RF output stage. The method of controlling the RF output stage is described herein as changing an input to the RF output stage.
- Electrosurgical techniques have been used to seal small diameter blood vessels and vascular bundles. Another application of electrosurgical energy is tissue welding. In this application, two layers of tissue are grasped and clamped together while electrosurgical power is applied. The two layers are thereby welded together. Tissue welding is similar to vessel sealing, except that a vessel or duct is not necessarily sealed in this process. For example, tissue welding may be used instead of staples for surgical anastomosis, Electrosurgical power has a desiccating effect on tissue during tissue welding or vessel sealing. As used herein, the term “electrosurgical desiccation” is meant to encompass any tissue desiccation procedure, including standard electrosurgical coagulation, desiccation, vessel sealing, and tissue welding.
- One of the problems associated with electrosurgical desiccation is undesirable tissue damage due to thermal effects. The tissue at the operative site is heated by the electrosurgical current. Healthy tissue adjacent to the operative site can become thermally damaged if too much heat is allowed to build up at the operative site. The heat may conduct to the adjacent tissue and cause a large region of tissue necrosis. This is known as thermal spread. The problem of thermal spread becomes important when electrosurgical tools are used in close proximity to delicate anatomical structures. Therefore, an electrosurgical generator that reduced the possibility of thermal spread would offer a better opportunity for a successful surgical outcome.
- Another problem that is associated with electrosurgical desiccation is a buildup of eschar on the surgical tool, Eschar is a deposit on an electrosurgical tool that is created from tissue that is desiccated and then charred by heat. The surgical tools win often lose effectiveness when they are coated with eschar. The buildup of eschar could be reduced when less heat is developed at the operative site.
- Practitioners have known that a measurement of electrical impedance of tissue is a good indication of the state of desiccation of the tissue. Several commercially available electrosurgical generators can automatically terminate output power based on a measurement of impedance. Several methods for determining the optimal point of desiccation are known in the field. One method sets a threshold impedance, and terminates power once the measured impedance of the tissue crosses the threshold. Another method terminates power based on dynamic variations in the impedance.
- A discussion of the dynamic variations of impedance of tissue can be found in the article, Vallfors and Bergdahl “Automatically Controlled Bipolar Electrocoagulation,” Neurosurgical Review, 7:2-3, pp. 187-190, 1984. FIG. 2 in the Vallfors article shows impedance as a function of time during heating of tissue. Valfors reports that the impedance value of tissue proved to be close to minimal at the moment of coagulation. Based on this observation, Vallfors suggests a micro-computer technique for monitoring the minimum impedance and subsequently terminating output power to avoid charring the tissue.
- A second article by Bergdahl and Vallfors, “Studies on Coagulation and the Development of an Automatic Computerized Bipolar Coagulator,” Journal of Neurosurgery, 75:1, 148-151, July 1991, discusses the impedance behavior of tissue and its application to electrosurgical vessel sealing. The Bergdahl article reported that the impedance had a minimum value at the moment of coagulation. The Bergdahl article also reported that it was not possible to coagulate safely arteries with a diameter larger than 2 to 2.5 millimeters. The present invention helps to overcome this limitation by enabling electrosurgical vessel seating of larger diameter vessels.
- U.S. Pat. No. 5,540,684 discloses a method and apparatus for electrosurgically treating tissue in a manner similar to the disclosures of Vallfors and Bergdahl. The '684 patent addresses the problem associated with turning off the RF output automatically after the tissue impedance has reached a minimum value. A storage device records maximum and minimum impedance values, and an algorithm computes an optimal time for terminating output power.
- U.S. Pat. No. 4,191,188 discloses a variable crest factor electrosurgical generator. The crest factor is disclosed to be associated with the coagulation effectiveness of the electrosurgical waveform.
- U.S. Pat. No. 5,472,443 discloses the variation of tissue impedance with temperature. The impedance of tissue is shown to fall, and then subsequently rise as the temperature is increased. The '443 patent shows a relatively lower temperature region (Region A in
FIG. 2 ) where salts, contained within the body fluids, are believed to dissociate, thereby decreasing the electrical impedance. The relatively next higher temperature region (Region B) is where the water in the tissues boils away, causing the impedance to rise. The relatively highest region (Region C) is where the tissue becomes charred, resulting in a slight lowering of impedance. - It would be desirable to have an electrosurgical generator that produced a clinically effective output and, in addition, reduced the amount of heat and thermal spread at the operative site. It would also be desirable to have an electrosurgical generator that produced a better quality seal for vessel sealing and tissue welding operations. It would also be desirable to have an electrosurgical generator that desiccated tissue by applying a minimal amount of electrosurgical energy.
- According to one aspect of the present disclosure an electrosurgical generator for applying output power to tissue is disclosed. The electrosurgical generator includes a tissue impedance measurement circuit configured to measure tissue impedance and a controller coupled to the tissue impedance measurement circuit. The controller is adapted to cycle output power from the electrosurgical generator to cause a cycling of the tissue impedance by applying the output power to tissue and then adjusting the output power to at least one of a lower output value and termination of output power. The controller is further adapted to re-apply the output power to tissue if tissue impedance does not indicate tissue desiccation and to terminate output power when the measured tissue impedance indicates tissue desiccation.
- According to another aspect of the present disclosure, an electrosurgical generator for treating tissue by applying energy is disclosed. The electrosurgical generator includes a desiccation detector configured to determine completeness of tissue desiccation and a controller coupled to the desiccation detector. The controller is adapted to cycle output power to cause a cycling of tissue impedance in response to the degree of tissue desiccation. The controller is further adapted to re-apply the output power to tissue if the desiccation detector does not indicate tissue desiccation.
- A method for applying electrosurgical energy to tissue to treat tissue is also contemplated by the present disclosure. The method includes the steps of: a) cycling output power from an electrosurgical generator to cause a cycling of tissue impedance by applying output power to tissue and then adjusting output power to at least one of a lower output value and termination of output power and re-applying output power to tissue if tissue impedance does not indicate tissue desiccation. The method also includes the steps of c) allowing the tissue impedance to fall to a predetermined minimum value and then raising the output power to cause an increase in tissue impedance and d) repeating steps b and c until tissue impedance at least reaches a predetermined value that corresponds to tissue desiccation.
- Particular embodiments of the present disclosure will be described herein below with reference to the accompanying drawings. In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail.
-
FIG. 1 is a block diagram representation of an adaptive oscillatory power curve according to the present invention. -
FIG. 2( a) is a sample of experimental data for a standard vessel sealing operation, showing output power as function of time. -
FIG. 2( b) is a sample of experimental data for a standard vessel sealing operation, showing load impedance as a function of time. -
FIG. 2( c) is a sample of experimental data for a standard vessel sealing operation, showing output current as a function of time. -
FIG. 2( d) is a sample of experimental data for a standard vessel sealing operation, showing output voltage as a function of time. -
FIG. 3( a) is a sample of experimental data for an adaptive power control generator, showing output power as fiction of time. -
FIG. 3( b) is a sample of experimental data for an adaptive power control generator, showing load impedance as a function of time. -
FIG. 3( c) is a sample of experimental data for an adaptive power control generator, showing output current as a function of time. -
FIG. 3( d) is a sample of experimental data for an adaptive power control generator, showing output voltage as a function of time. -
FIG. 4( a) is a representation of a power curve for a standard electrosurgical generator. -
FIG. 4( b) is a representation of an adaptive oscillatory power curve. - The present invention discloses an adaptive, oscillatory power curve which is able to reduce thermal spread in each of these areas by applying power in a cyclical fashion, rather than continuously. During the periods of reduced power application, thermal energy is allowed to dissipate which reduces direct thermal conduction. Also, the steam exits the weld site in smaller bursts, which produces less thermal damage than one large burst. Finally, the impedance between the jaws of the electrosurgical instrument is kept low, which allows current to flow more directly between the jaws.
- Charring is also reduced. High voltages contribute to tissue charring, which is why it is preferable to limit the output voltage of the electrosurgical generator to 120 volts, and to periodically reduce it to a lower value during power cycling. A relatively low voltage is also important because it prevents electrical sparks, or arcs, from passing through the tissue and burning small holes in the newly sealed, or welded, tissue.
- The transparency, or clarity, at the weld site has been identified as an indicator of successful seal completion. It also gives the surgeon visual feedback as to whether the seal is a success. Preliminary findings indicate that this method may also increase weld site transparency. The reason for this is unknown, but it seems reasonable that reduced charring will allow the weld site to remain more transparent.
- Referring to
FIG. 1 , a block diagram of an adaptive oscillatorypower control system 10 is shown. The line designated by the letter A represents the command input signal to thecontrol system 10. The command input signal A is preferably a periodic function, and in stain embodiments the period may vary depending on the dynamics of the tissue. The signal A is representative of the desired tissue impedance. A measurement of tissue impedance is represented by line B.A summing block 11 compares the command input signal A with the measured tissue impedance B to produce a difference signal C.The summing block 11 may be comprised of an electrical comparator circuit as is commonly known to control systems engineers. - The difference signal C may be input to a
controller 12 that generates a control signal D. The control signal D adjusts or terminates the output power of the electrosurgical generator by changing the state of the RF.Output Stage 13. Thecontroller 12 may be comprised of an algorithm in a microprocessor that determines the conditions for power termination based on the amplitude of the control signal. Alternatively and equivalently, thecontroller 12 may be connected directly to the measured tissue impedance B to terminate power based on the amplitude of the measured tissue impedance B. Thecontroller 12 may be comprised of any combination of proportional integral, and derivative control laws that are known to control system engineers. Other types of control laws, such as “bang-bang” control laws, are effective equivalents. - In one embodiment, the command input signal A has a cyclic pattern, for example a sine wave or a square wave. The cyclic nature of the command input signal A causes the
control system 10 to regulate the output power in a cyclic manner to achieve beneficial surgical effects. Thecontroller 12 monitors the difference signal C to determine the response of the output power E. In one embodiment, when the difference signal C is large, and the impedance measurement B is above threshold, then thecontroller 12 terminates the output power E. - The control signal D is preferably connected to an R.F.
Output Stage 13. The control signal D preferably changes a driving voltage in the R.F. output stage to thereby change the RMS output power from the electrosurgical generator, shown as line E inFIG. 1 . Alternatively and equivalently, the control signal D may change the duty cycle of the R.F.Output Stage 13 thereby effectively changing the RMS output power. Other means of changing RMS output power from an R.F. Output Stage, such as changing current, are known to electrical engineers. - The generator R.F.
Output Stage 13 causes the electrosurgical generator to output a power level E to thetissue 14 of the patient. Thetissue 14 becomes desiccated, thereby changing the electrical impedance, shown by F inFIG. 1 . The electrical impedance F of the tissue is measured by animpedance measurement circuit 15 and reported as the measured tissue impedance B. Theimpedance measurement circuit 15 may be any form of electrical circuit that measures, or estimates, electrical impedance. The measured tissue impedance B is preferably an electrical signal that is proportional to the actual tissue impedance F. - Electrical engineers will recognize that output power from an electrosurgical generator can be adjusted in several ways. For example, the amplitude of the output power can be adjusted. In another example, the output power can be adjusted by changing the duty cycle or the crest factor. The change or adjustment in output power, as used herein is meant to refer any change or adjustment in the root mean square (RMS) value of the output power of the electrosurgical generator.
- In operation, the
control system 10 is designed to cycle the tissue impedance F for preferably several cycles in order to achieve beneficial effects. Thus, the command input signal A is a cyclically varying signal such as a sine wave. An example of cyclical impedance behavior of tissue is shown inFIG. 3( b). The generator output power that caused the cyclical impedance behavior is shown inFIG. 3( a). The cyclical behavior of the present invention can be contrasted with a standard electrosurgical generator wherein the output power is shown inFIG. 2( a) and the tissue impedance is shown in 2(b). - The present invention discloses an adaptive, oscillatory power curve which is able to reduce thermal spread in each of these areas by applying power in a cyclical fashion, rather than continuously. During the periods of reduced power application, thermal energy is allowed to dissipate which reduces direct thermal conduction. Also, the steam exits the weld site in smaller bursts, which produces less thermal damage than one large burst. Finally, the impedance between the jaws of the electrosurgical instrument is kept low, which allows current to flow more directly between the jaws.
- Charring is thought to be reduced by the present invention. High voltages contribute to tissue charring, which is why it is preferable to limit the output voltage of the electrosurgical generator to 120 volts, and to periodically reduce it to a lower value during power cycling. A relatively low voltage is also important because it prevents electrical sparks, or arcs, from passing through the tissue and burning small holes in the newly sealed, or welded, tissue.
- The transparency, or clarity, at the weld site has been identified as an indicator of successful seal completion. It also gives the surgeon visual feedback as to whether the seal is a success. Preliminary findings indicate that this method may also increase weld site transparency. The reason for this is unknown, but it seems reasonable that reduced charring will allow the weld site to remain more transparent.
- A plot of output power vs. load impedance is called a “power curve.” A representation of a standard power curve is shown in
FIG. 4( a). At low impedance, the output is typically current limited, and this is shown as the “constant current” line segment onFIG. 4( a). At midranges of impedance, the electrosurgical generator has a power control system that maintains the output power at a constant level by adjusting the output voltage, as shown by the “constant power” line segment onFIG. 4( a). Eventually, the load impedance becomes large, and the output power cannot be maintained without applying unacceptably high output voltages. Thus, a voltage limit is reached, and the output power drops off because the output current is falling and the output voltage is at a limit. The drop in output power is shown as the “constant voltage” line segment inFIG. 4( a). - The present invention is related to an electrosurgical generator having an adaptive oscillatory power curve as shown in
FIG. 4( b). The adaptive oscillatory power curve is produced by a power control system in the electrosurgical generator. The design details of the control system can be implemented in several ways which are well known to control system engineers. - The first part of the adaptive oscillatory power curve, shown at the line segment I in
FIG. 4( b), is similar to the standard power curve, wherein the generator applies high current into a low impedance load until a maximum power limit, shown as A, is reached. In the next “leg” of the power curve, shown by line segment B, output current begins to fall, and output voltage begins to rise as the generator adjusts the output voltage to maintain constant output power at the level marked by A. The generator then begins looking for signs to indicate the onset of boiling in the tissue. Such signs include a very rapid rise in impedance, or a high value of voltage, such as 120 volts. The local maximum of the impedance curve is shown by letter K inFIG. 4( b). The dotted line, marked C and labeled V=120 V, shows the possible output power if the generator were to maintain a voltage limit of 120 volts, which is a preferred voltage limit. Rather than follow the V=120 V line, a controller in the generator drops the output power. This can be accomplished, in one embodiment, by dropping the output voltage limit to between zero and 70 volts, and preferably 50 volts, as shown in line segment D. In another embodiment of the control system, the output power can be reduced by other combinations of output current reduction and/or output voltage reduction. - As a consequence of the lower voltage limit, the output power drops to the level indicated by H in
FIG. 4( b). In certain embodiments, H may be zero watts. At this lower output power, desiccation stops and the tissue impedance starts to fall. A preferred lower voltage limit of 50 volts may be used as shown by dotted line E and marked “V=5 volts”. Once the impedance has reached a local minimum, shown by J, or after a set period of time, the power control system raises the output power back to level A, which corresponds to an output voltage limit of 120 volts in the preferred embodiment. Thus, the output power rises back to level A, and the impedance rises again, until the onset of boiling or an impedance threshold is reached. The cyclical portion of the power curve incorporating line segments B, D, and E is an important part of this invention and will continue until the tissue is desiccated. When the tissue is desiccated, the power will terminate as shown when impedance reaches point L. In certain embodiments, point L will be substantially the same as point K. - The behavior shown in
FIG. 4( b) can be observed inFIGS. 3( a), 3(b), 3(c) and 3(d). Power oscillations between 120 watts and 20 watts inFIG. 3( a) correspond to cyclical movement between power level A and power level H inFIG. 4( b). Impedance oscillations inFIG. 3( b) correspond to cyclical movement between impedance level K and impedance level J inFIG. 4( b). It will be understood by control systems engineers thatFIG. 4( b) is highly idealized, and the cyclical behavior may not always reach exactly the same local maxima and minima. This can be observed inFIG. 3( a), where the local maxima of the power curve may not always reach 120 volts. - It is theorized by the inventor that the following phenomena occur. The initial high output power initiates boiling in the tissues. The subsequent low output power is insufficient to maintain boiling, and hence boiling in the tissue stops. After boiling stops, if the tissue is not completely desiccated then the impedance will fall to a lower value. Next, the low impedance allows output power to increase, which re-heats the tissue to the point of boiling. The voltage is also pulled higher during the process, and remains so until the power curve can sense the onset of boiling, and lower the voltage, preferably back to 50 volts. The process continues until the tissue is fully desiccated. An oscillation is one cycle of high output power followed by low output power.
-
FIGS. 2( a) through 2(d) show experimental results on tissue samples using a standard power curve.FIGS. 3( a) through 3(d) show experimental results using an adaptive oscillatory power curve. The general nature of the invention can be seen by comparingFIG. 2( a) withFIG. 3( a).FIG. 2( a) shows a 100 watt electrosurgical output that is applied continuously to tissue. As the tissue desiccates, the impedance of the tissue rises and the output power inFIG. 2( a) is seen to fall off below 20 watts. In contrast,FIG. 3( a) shows an oscillating output power that varies from approximately 100 watts to approximately 20 watts. The effects on tissue impedance can be seen by comparingFIG. 2( b) withFIG. 3( b). The tissue impedance resulting from the standard power curve is shown to continuously increase inFIG. 2( b), perhaps after an initial drop. The tissue impedance resulting from the adaptive oscillatory power curve is shown to oscillate inFIG. 3( b) and thus has several local minima. - Output voltage and output current show a cyclic behavior in the adaptive oscillatory power curve. The cyclic behavior is absent in the standard power curve.
FIGS. 2( c) and 3(c) can be compared to show the difference in output current between the standard power curve and the adaptive oscillatory power curve. In each case the maximum output current rises above 2 amps RMS.FIGS. 2( d) and 3(d) can be compared to show the difference in output voltage between the standard power curve and the adaptive oscillatory power curve. A voltage limit, preferably in eachcase 120 volts, prevents arcing that might leave pinholes in the tissue seal. - In one embodiment of the adaptive oscillatory power curve, the generator temporarily lowers the output voltage limit to 50 volts whenever the output voltage reaches 120 volts. This causes a reduction in output power, and if the tissue is not completely desiccated, a corresponding significant reduction in tissue impedance. After the reduction in tissue impedance, the output voltage limit is reset to 120 volts, allowing a rise in output power. This reduction and subsequent rise in output power constitutes a cycle.
- Designers of electrosurgical generators have found that impedance is a good indicator of the desiccation state of the tissue. However, skilled artisans will recognize that it may not be necessary to compute an exact value for impedance. An electrical measurement that is proportional to the tissue impedance can be used as a functional equivalent. In one embodiment, the control system can properly create the adaptive oscillatory power curve based on measurements of time, and output voltage.
- Table 1 shows a comparison between two sets of tests which compare a standard power curve with an adaptive oscillatory power curve.
Test 1 indicates use of the standard power curve, whileTest 2 indicates the use of the adaptive oscillatory power curve. Size indicates the vessel diameter in millimeters, burst pressures are measured in p.s.i., sticking, charring, and clarity are subjective measures ranked from 0 to 3, (where 0 represents a low value for sticking and charring, and 0 represents a poor value for clarity), and ts indicates thermal spread, measured in millimeters. - TABLE 1 Comparison of Standard Power Curve with Adaptive Power Curve Test # samples size bp stick charring clarity ts 1 (mean) 19 2.57 17.26 0.63 1.11 1.89 2.11 1 (SD) 1.35 1.04 0.76 0.81 1.29 0.74 1 (min) 1 12.96 1 (max) 6 17.50 2 (mean) 20 2.55 17.39 0.80 0.60 1.95 1.65 2 (SD) 1.36 0.44 1.06 0.60 1.36 0.81 2 (min) 1 15.52 2 (max) 5 17.50
- Table 1 illustrates that the adaptive oscillatory power curve (Test 2) has several advantages over the standard power curve (Test 1). Most notable is the lower amount of thermal spread: a mean value of 2.1 mm for the standard power curve, and 1.65 mm for the adaptive oscillatory power curve. The subjective measures for sticking, charring and clarity of the weld show that the adaptive oscillatory power curve offer improvements over the standard power curve.
- In general, the invention is an electrosurgical generator for treating tissue, wherein the electrosurgical generator comprises a circuit for generating a measurement of the load impedance, and an output power controller having means for inducing multiple oscillations of the load impedance in response to the measurement. The load impedance refers to the impedance of the tissue being treated by the electrosurgical generator. The circuit for generating a measurement of the load impedance can be analog or digital, and typically requires an output voltage sensor and an output current sensor. The output voltage is divided by the output current to compute a measurement of load impedance.
- The means for inducing multiple oscillations of the load impedance preferably comprises a control system which can selectively control the output voltage to cause appropriate oscillations of the output power. In many electrosurgical generators, an output power control circuit has an adjustable voltage supply connected to the primary side of an isolation transformer. The secondary winding of the transformer is connected to an output resonant circuit. The voltage supply has an adjuster for changing the voltage to the transformer, and thereby changing the output voltage of the electrosurgical generator. A digital signal may be used to control the voltage supply.
- The means for inducing multiple oscillations preferably comprise a feedback control system, where the feedback is a measurement of the load impedance. The control system preferably includes an algorithm in a microprocessor. The algorithm in the microprocessor can monitor the load impedance and determine how the load impedance is responding to a change in the output power.
- In the preferred embodiment, the control system sets an output voltage limit of 120 volts RMS, and then controls the output power to a user desired setting, for example 100 watts. When the impedance is relatively low, a high current will combine with an output voltage of less than 120 volts to yield the desired power of 100 watts. As the impedance rises, the output current will fall, and the output voltage will be increased by the circuit to maintain the desired output power. When the voltage limit of 120 volts is reached, the control system will automatically lower the output voltage to a low value, preferably 50 volts. This effectively lowers the output power. If the tissue is not completely desiccated, the lower output power will cause the impedance to drop significantly. Once a local impedance minimum is detected, or after a set period of time, the output voltage limit is reset to 120 volts by the control system, and the cycle repeats. It has been found through experimentation that the oscillations of the load impedance will occur in the frequency range of one to twenty hertz, and this range has been referred to herein as the thermal bandwidth. In one embodiment, the control system terminates the output power after a set period of time which was three seconds. Alternatively, the control system can terminate power when the impedance reaches a threshold of 2000 ohms. Another alternative is to terminate output power when the measurement of impedance indicates that the impedance does not substantially fall in response to a drop in the output power.
- The present invention is applicable to any form of electrosurgical coagulation. The benefits of the present invention, including reduced thermal spread, less eschar buildup, and improved desiccation, can be applied to both monopolar and bipolar electrosurgical generator outputs. While a particular preferred embodiment has been illustrated and described, the scope of protection sought is in the claims that follow.
Claims (18)
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Also Published As
Publication number | Publication date |
---|---|
AU5289998A (en) | 1998-10-15 |
DE69831525T2 (en) | 2006-06-22 |
JPH10286261A (en) | 1998-10-27 |
DE69831525D1 (en) | 2005-10-20 |
EP0870473A3 (en) | 2001-01-24 |
EP1616529A2 (en) | 2006-01-18 |
ES2248877T3 (en) | 2006-03-16 |
USRE40388E1 (en) | 2008-06-17 |
EP1616529B1 (en) | 2013-09-25 |
JP4191810B2 (en) | 2008-12-03 |
US6228080B1 (en) | 2001-05-08 |
US6033399A (en) | 2000-03-07 |
DE29805534U1 (en) | 1998-08-13 |
CA2232018C (en) | 2002-02-12 |
EP0870473B1 (en) | 2005-09-14 |
CA2232018A1 (en) | 1998-10-09 |
EP1616529A3 (en) | 2006-02-15 |
EP0870473A2 (en) | 1998-10-14 |
AU738541B2 (en) | 2001-09-20 |
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